Medical devices for implantation in bone tissue and characterization of fracture sites

Abstract

The present invention provides a structure configured to be at least partially implanted in the body of a smart medical device, and an electronics cartridge configured to be inserted into the structure after it has been implanted in the body. [Solution] The structure of the present invention is preferably a sheath screw used in the treatment of fractures. The medical device has an impedance sensor that monitors and reports the healing status of the fracture. This sensor includes components of an electronic cartridge and an electrode associated with either a sheath screw or an insertable electronic cartridge.

Description

Technical Field

[0001] The present disclosure (the present invention) generally relates to a medical device having a structure configured to at least partially extend into bone tissue. For example, the structure may be part of a screw, pin, rod, nail, an implant for joint replacement (e.g., hip joint, shoulder joint, knee joint, etc.), part of a spinal fixation device, or part of other orthopedic devices. The medical device has a sensor for obtaining a measurement indicating the healing state of fractured bone tissue in which the medical device is implanted, and a communication circuit for transmitting such measurement to an external device.

[0002]

Citation of Related Applications

Background Art

[0003] Reliable assessment of bone healing is essential for the successful treatment of fractures. Delayed or nonunion of fractures has a high incidence (incidence) of up to 5-10%, and these cases can be extremely painful and dangerous to the patient's health, and can also result in unavoidable high costs. Current techniques for monitoring the healing status of fractures utilize non-invasive imaging modalities, such as X-ray, CT scans, ultrasound, and magnetic resonance imaging (MRI). Because the formation of bridging callus in long bone fractures takes more than three months, there are limitations to relying on conventional X-rays to monitor the degree of healing. Computed tomography (CT) scanning is a widely used modality, and such CT scans can evaluate bridging callus in the later stages of healing and confirm the degree of healing. Technological advances in dynamic contrast-enhanced MRI and nuclear imaging may offer advantages in the assessment of infectious nonunion. Emerging evidence supports the use of ultrasound to detect bridging callus prior to radiographic confirmation, which may be helpful in predicting patients with high-risk nonunion. However, each of these techniques tends to be most useful in the final stages of healing, and their effectiveness depends on patient compliance—whether the patient will undergo regular imaging examinations. [Overview of the project] [Problems that the invention aims to solve]

[0004] Therefore, it is desirable to provide a technology that characterizes the fracture site throughout all stages of healing and in an automated manner that does not rely on imaging or patient compliance. The technical ideas disclosed herein address these and other needs. [Means for solving the problem]

[0005] In summary, this disclosure relates to medical devices, optionally referred to herein as implantable and / or smart medical devices, methods for manufacturing medical devices, methods for using medical devices, including methods for treating with medical devices, methods for using medical devices, including methods for characterizing the degree of healing with medical devices, and other aspects disclosed herein. Medical devices generally have a structure configured to extend at least partially into bone tissue. For example, the structure may be a screw, pin, rod, nail, part of a joint replacement implant (e.g., hip, shoulder, knee joint, etc.), part of a spinal fixation device, or part of another orthopedic device. In one embodiment, the medical device is a screw. An implantable smart medical device has, for example, a sensor that obtains one or more measurements representing the healing state of bone tissue in a fractured state in which the medical device is implanted, for example, a healing state, and a communication circuit system that transmits such measurements to an external device.

[0006] For example, in one view, the present disclosure provides a smart medical device having a structure configured to be at least partially implanted in the body, and an electronic cartridge configured to be inserted into the structure after it has been implanted in the body. The structure may be a sheath screw used in treating a fracture. The medical device has an impedance sensor that monitors and reports the healing status of the fracture. The sensor includes components and electrodes of an electronic cartridge, either associated with the sheath screw or associated with an insertable electronic cartridge.

[0007] In one view, the present disclosure relates to a medical device having a structure through which a lumen extends at least partially, and an insertable electronics cartridge containing electronics. The structure is configured to be implanted at least partially in the body, and the electronics cartridge is configured to be inserted into the lumen after the implantation of the structure.

[0008] The disclosure also relates to a medical device having a sheath-like structure having a plurality of electrodes on the outer surface of the structure, and an insertable electronics cartridge. The sheath-like structure has a lumen extending through it, and the sheath-like structure is configured to be implanted at least partially inside the body. The electronics cartridge contains electronics, and the electronics cartridge is configured to be inserted into the lumen of the sheath-like structure such that one or more electrical couplings between the electronics and the plurality of electrodes are achieved upon insertion.

[0009] The disclosure also relates to a medical device having a sheath-like structure having at least one hole provided through the side wall of the structure, and an insertable electronics cartridge. The sheath-like structure has a lumen extending through it, and the sheath-like structure is configured to be implanted at least partially inside the body. The electronics cartridge has a plurality of electrodes and electronics electrically coupled to these electrodes. The electronics cartridge is inserted into the lumen and is configured to align the plurality of electrodes with the at least one hole upon such insertion.

[0010] The disclosure also relates to a medical device having a sheath-like structure with a distal end opening and a proximal end opening, and an insertable electronics cartridge. The sheath-like structure has a lumen extending through it, and the sheath-like structure is configured to be implanted in the body at least partially. The electronics cartridge has a plurality of electrodes and electronics electrically coupled to these electrodes. The electronics cartridge is inserted into the lumen and is configured, upon insertion, to position a first electrode of the plurality of electrodes at the distal end opening of the sheath-like structure and a second electrode of the plurality of electrodes at the proximal end opening.

[0011] This disclosure also relates to a medical device having a short sheath-like structure with a distal end opening and a proximal end opening, and an insertable electronics cartridge. The sheath-like structure has a lumen extending through it, and the sheath-like structure is configured to be implanted at least partially in the body. The electronics cartridge has a plurality of electrodes and electronics electrically coupled to these electrodes. The electronics cartridge is inserted into the lumen and is configured to position the plurality of electrodes beyond the distal end opening of the sheath-like structure upon such insertion.

[0012] This disclosure also relates to a medical device with pre-integrated electronics. The medical device is configured to be implanted at least partially in the body, and the medical device has a structure comprising a head and a shaft, each having a head cavity and a shaft cavity, respectively. The pre-integrated medical device further comprises electronics positioned in one or more of the head cavity and shaft cavity, and at least one electrode associated with the shaft and electrically coupled to the electronics.

[0013] This disclosure also relates to a medical device having a sheath-like structure with an electronics cartridge pre-installed. The sheath-like structure is configured to be implanted in the body and has a lumen extending at least partially through it. The electronics cartridge is at least partially located within the lumen, and the electronics are permanently fixed within the lumen. The sheath-like structure has a plurality of holes penetrating its side walls and a plurality of electrodes, each associated with each of the plurality of holes. The electronics cartridge has electronics and a plurality of electrical contacts, each aligned with each of the holes to achieve electrical coupling between the electronics and each of the plurality of electrodes.

[0014] From one perspective, the medical devices of this disclosure can be used to help treat fractures in bone tissue. For example, the medical device may be in the form of a screw positioned across the fracture site in the bone tissue, in which case the screw helps to hold the bone tissue together adjacent to the fracture site, thus providing a stabilizing function to the bone during healing. Optionally, the medical device may have little to no stabilizing function, but instead, it may be implanted in the fractured bone tissue, optionally across the fracture site in the bone tissue, primarily to characterize the fracture site during the healing process, or solely for that purpose, thus providing a characterizing function. Optionally, the implanted medical device may exhibit both stabilizing and characterizing functions. In particular, if the medical device of this disclosure has little to no stabilizing function, it may be used in conjunction with other medical devices, such as standard orthopedic screws that do not have sensors that primarily provide a stabilizing function. Thus, from one perspective, the present disclosure provides a set of medical devices, at least one of which is the smart medical device of the present disclosure, which provides a characterizing function (and optionally some stabilizing function), and at least one of which is used primarily to provide or solely to provide a stabilizing function. When in use, the smart medical device of the present disclosure is preferably placed in bone tissue in a location where a stabilizing function is not required, i.e., in a non-load / unloaded location. The medical device used primarily or exclusively to provide a stabilizing function is preferably placed in a load-bearing location in bone tissue.

[0015] The disclosure also relates to an implantable medical device for characterizing a fracture site in bone. The medical device has an implant configured to be implanted in bone and at least partially across the fracture site. The implant has an impedance sensor having a first electrode and a second electrode, and a detection module configured to obtain impedance measurements between the first electrode and the second electrode. The implant further has a controller with memory configured to process and store impedance measurements, and a communication circuit system configured to transmit impedance measurements to an external device.

[0016] This disclosure also relates to an implantable medical device for characterizing a fracture site in bone. The medical device comprises a first implant and a second implant, each configured to be at least partially implanted in the bone, and a third implant positioned adjacent to the bone and across the fracture site, and configured to be fixed in place by the first and second implants. The first implant has a first electrode, and the second implant has a second electrode. The medical device further comprises an impedance sensor and a detection module having the first and second electrodes. The detection module is located in one or more of the first, second, or third implants, and is configured to obtain impedance measurements between the first and second electrodes. The medical device further comprises a controller with memory configured to process and store the impedance measurements, and a communication circuit system configured to transmit the impedance measurements to an external device. The controller, memory, and communication circuit system are preferably located in one or more of the first, second, or third implants.

[0017] The disclosure also relates to a method for characterizing a fracture site via electrodes positioned on opposite sides of the fracture site. The method includes obtaining multiple measurements of the electrical properties of a tissue over time using a plurality of electrodes associated with a single implant and positioned within the bone tissue and across the fracture site. The plurality of electrodes include a first electrode and a second electrode positioned on opposite sides of the fracture site. The method further includes processing the measurements to determine a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site.

[0018] The disclosure also relates to a method for characterizing a fracture site via electrodes placed within the fracture cavities. The method involves obtaining multiple measurements of the electrical properties of a tissue over time using multiple electrodes associated with a single implant and positioned within the bone tissue at the fracture site. The multiple electrodes include a first electrode and a second electrode, each located within the fracture cavities. The method further includes processing the measurements to determine a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site.

[0019] The disclosure also relates to a method for characterizing a fracture site using electrodes that straddle the fracture gap. The method includes obtaining multiple measurements of the electrical properties of a tissue over time using multiple electrodes placed in the bone tissue at the fracture site. The multiple electrodes include a first electrode and a second electrode, each straddling the fracture gap. The method further includes processing the measurements to determine a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site.

[0020] The disclosure also relates to a method for manufacturing an implantable medical device. The method includes the step of creating a plurality of holes through the side wall of a sheath-like structure having a through-lumen and configured to be at least partially implanted in the body. The method further includes the step of associating electrodes with each of the plurality of holes, and associating an electronics cartridge with the lumen of the sheath-like structure. The electronics cartridge has electronics and a plurality of electrical contacts, and such association achieves electrical coupling between the electronics and each electrode by aligning each of the plurality of electrical contacts with each of the holes, respectively.

[0021] This disclosure also relates to a method for implanting a medical device. The method includes the step of implanting an implant structure at least partially into the body. The structure has a lumen extending at least partially through it. The method further includes, after implantation of the implant structure, inserting an electronics cartridge into the lumen.

[0022] The disclosure also relates to a tool for implanting an implant structure, the implant structure having a proximal end with a head, a shaft extending from the head to the distal end of the implant structure, and a lumen extending through the shaft. The tool has a drill bit and a mechanism for applying rotational torque to the drill bit. The drill bit has a first portion configured to be directly coupled to the head of the implant structure, and a second portion extending from the first portion. The second portion is configured to extend at least partially into the lumen of the implant structure.

[0023] The present disclosure also relates to a coupling device for implanting an implant structure, the implant structure having a proximal end with a head and a shaft extending from the head to the distal end of the implant structure. The coupling device has a body with a proximal end region and a distal end region. The distal end region is configured to effect a mechanical coupling to the distal end portion of the implant structure. The coupling device may further have a cap configured to couple to the proximal end region of the body rather than directly to the implant structure.

[0024] Exemplary features, their nature, and various advantages of the present disclosure will become apparent from the following detailed description of the accompanying drawings and various embodiments. Non-limiting and non-exclusive embodiments will be described with reference to the accompanying drawings, where the same reference numerals indicate the same parts throughout the various figures unless otherwise specified. The dimensions and relative positions of the elements in the figures are not necessarily drawn to scale. For example, the shapes of the various elements are selected, enlarged, and positioned to make the drawings understandable. The particular shapes of the elements depicted are selected to be recognizable in the drawings. One or more embodiments will be described below with reference to the accompanying drawings.

Brief Description of the Drawings

[0025] [Figure 1A] Schematic diagram of a configuration example of a smart medical device. [Figure 1B] Schematic diagram of a configuration example of a smart medical device having a partially threaded cannulated screw with a pair of electrodes. <0000l00>Schematic diagram of a configuration example of a smart medical device having an electronics cartridge configured to be inserted into a cannulated screw, showing a state where a pair of electrical contacts carried by the cartridge are aligned with a pair of electrodes. [Figure 1D] Schematic diagram of a partially threaded cannulated screw, showing a state where the unthreaded portion is coated with a certain material. [Figure 2A]This is a schematic diagram of a fixing mechanism for securing an electronics cartridge inside a sheath-shaped screw. [Figure 2B] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 3A] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 3B] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 4] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 5A] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 5B] This is a schematic diagram of another fixing mechanism for securing an electronics cartridge within a sheath-shaped screw. [Figure 6A] Figures 1A to 1C are schematic diagrams of different configurations of sheath-shaped screws with threads throughout, which can be used in medical devices, and show an example configuration with only one pair of electrodes. [Figure 6B] Figures 1A to 1C are schematic diagrams of different configurations of a sheath-shaped screw with threads throughout, which can be used in medical devices, and show an example configuration with two pairs of electrodes. [Figure 6C] Figures 1A to 1C are schematic diagrams of different configurations of sheath-shaped screws with threads throughout, which can be used in medical devices, and show examples of configurations with electrodes arranged in an array. [Figure 7A] This is a schematic diagram of a smart medical device having a sheath-shaped screw with a pair of electrodes and an electronics cartridge configured to be insertable into the sheath-shaped screw, showing the pair of electrical contacts supported by the cartridge aligned with the electrodes. [Figure 7B]This is a schematic diagram of a smart medical device having a sheath-shaped screw with a pair of electrodes, and an electronics cartridge (shown in cross-section) configured to be insertable into the sheath-shaped screw, with the pair of electrical contacts supported by the cartridge aligned with the electrodes. [Figure 8A] This is a schematic diagram of a smart medical device having a sheath-shaped screw with an array of electrodes, and an electronics cartridge configured to be insertable into the sheath-shaped screw, showing a state in which numerous electrical contacts supported by the cartridge are aligned with the electrodes. [Figure 8B] This is a schematic diagram of a smart medical device having a sheath-shaped screw with an array of electrodes, and an electronics cartridge (shown in cross-section) configured to be insertable into the sheath-shaped screw, with a number of electrical contacts supported by the cartridge aligned with the electrodes. [Figure 9A] Figure 1C is a schematic diagram showing different configurations of the head end of an electronics cartridge. [Figure 9B] Figure 1C is a schematic diagram showing different configurations of the head end of an electronics cartridge. [Figure 10A] This is a schematic diagram of a smart medical device having a sheath-shaped screw with a pair of electrodes covering the surface of the screw, and an electronics cartridge configured to be insertable into the sheath-shaped screw, with the pair of electrical contacts supported by the cartridge aligned with the electrodes. [Figure 10B] This is a schematic diagram of a smart medical device having a sheath-shaped screw with a pair of electrodes covering the surface of the screw, and an electronics cartridge configured to be insertable into the sheath-shaped screw, with the pair of electrical contacts supported by the cartridge aligned with the electrodes. [Figure 11A]This is a schematic diagram of a smart medical device having a sheath-shaped screw with four electrodes covering its surface, and an electronics cartridge configured to be insertable into the sheath-shaped screw, where the four electrical contacts supported by the cartridge are aligned with the conductive trace lines of the electrodes. [Figure 11B] This is a schematic diagram of a smart medical device having a sheath-shaped screw with four electrodes covering its surface, and an electronics cartridge configured to be insertable into the sheath-shaped screw, where the four electrical contacts supported by the cartridge are aligned with the conductive trace lines of the electrodes. [Figure 12A] This is a schematic diagram of a smart medical device having a split-type sheath-shaped screw with a distal and proximal portion each equipped with electrodes, and an electronics cartridge configured to be insertable into the sheath-shaped screw, with the electrical contacts supported by the cartridge aligned with the electrodes. [Figure 12B] This is a schematic diagram of a smart medical device having a split-type sheath-shaped screw with a distal and proximal portion each equipped with electrodes, and an electronics cartridge configured to be insertable into the sheath-shaped screw, with the electrical contacts supported by the cartridge aligned with the electrodes. [Figure 12C] This is a schematic diagram of a smart medical device having a split-type sheath-shaped screw with a distal and proximal portion each equipped with electrodes, and an electronics cartridge configured to be insertable into the sheath-shaped screw, with the electrical contacts supported by the cartridge aligned with the electrodes. [Figure 13A] This is a schematic diagram of a configuration example for a different type of smart medical device, showing a state where electrodes supported by a cartridge are aligned with the slots. [Figure 13B] This is a schematic diagram of a configuration example for a different type of smart medical device, showing a state where electrodes supported by a cartridge are aligned with the slots. [Figure 13C] This is a schematic diagram of a smart medical device configuration example, showing an electrode supported by a cartridge aligned with the slots in a sheath-shaped screw. [Figure 13D] This is a schematic diagram of a smart medical device configuration example, which has an electronics cartridge configured to be insertable into a sheath-shaped screw, and shows the electrodes supported by the cartridge aligned with the slots. [Figure 14A] This is a schematic diagram of another example of a smart medical device configuration, showing how electrodes supported by a cartridge are aligned with holes. [Figure 14B] This is a schematic diagram of another example of a smart medical device configuration, showing how electrodes supported by a cartridge are aligned with holes. [Figure 14C] This is a schematic diagram of another configuration example of a smart medical device having a tubular screw with numerous holes, showing how electrodes supported by a cartridge are aligned with the holes. [Figure 14D] This is a schematic diagram of another example configuration of a smart medical device having an electronics cartridge configured to be insertable into a sheath-shaped screw, showing the electrodes supported by the cartridge aligned with the holes. [Figure 15A] This is a schematic diagram of another example of a smart medical device configuration, showing a state where a pair of electrodes supported by a cartridge are aligned with a pair of holes. [Figure 15B] This is a schematic diagram of another example of a smart medical device configuration, showing a state where a pair of electrodes supported by a cartridge are aligned with a pair of holes. [Figure 15C] This is a schematic diagram of another configuration example of a smart medical device having a sheath-shaped screw with a pair of holes, showing a pair of electrodes supported by a cartridge aligned with the pair of holes. [Figure 15D]This is a schematic diagram of another configuration example of a smart medical device having an electronics cartridge configured to be insertable into a sheath-shaped screw, showing a pair of electrodes supported by the cartridge aligned with a pair of holes. [Figure 16A] This is a schematic diagram of another example of a smart medical device configuration, showing a state where the tip electrode is aligned with the distal end of a sheath-shaped screw, and a cap electrode, also supported by a cartridge, is exposed at the head of the screw. [Figure 16B] This is a schematic diagram of another example of a smart medical device configuration, showing a state where the tip electrode is aligned with the distal end of a sheath-shaped screw, and a cap electrode, also supported by a cartridge, is exposed at the head of the screw. [Figure 16C] This is a schematic diagram of another configuration example of a smart medical device having a sheath-shaped screw, in which the tip electrode is aligned with the distal end of the sheath-shaped screw, and the cap electrode, also supported by a cartridge, is exposed at the head of the screw. [Figure 16D] This is a schematic diagram of another example of a smart medical device configuration having an electronics cartridge that can be inserted into a sheath-shaped screw, in which the tip electrode is aligned with the distal end of the sheath-shaped screw, and the cap electrode, also supported by the cartridge, is exposed at the head of the screw. [Figure 17A] This is a schematic diagram of another example of a smart medical device configuration, showing a state in which a portion of the cartridge, which carries the distal and proximal electrodes, penetrates the distal end of a sheath-shaped screw. [Figure 17B] This is a schematic diagram of another configuration example of a smart medical device having a sheath-shaped screw, showing a state in which a portion of the cartridge carrying the distal and proximal electrodes penetrates the distal end of the sheath-shaped screw. [Figure 17C]This is a schematic diagram of another example of a smart medical device configuration having an electronic cartridge that can be inserted into a sheath-shaped screw, showing a state in which a portion of the cartridge, which carries distal and proximal electrodes, penetrates the distal end of the sheath-shaped screw. [Figure 18A] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18B] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18C] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18D] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18E] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18F] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18G] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18H] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18I] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 18J] This is a schematic diagram of the tools and technologies for implanting smart medical devices. [Figure 19A] This is a schematic diagram of a pre-built-in configuration example of a smart medical device having a screw with an integrated electronics package. [Figure 19B] This is a schematic diagram of a pre-built-in configuration example of a smart medical device having a screw with an integrated electronics package. [Figure 19C] This is a schematic diagram of a pre-built-in configuration example of a smart medical device having a screw with an integrated electronics package. [Figure 19D]This is a schematic diagram of a pre-built-in configuration example of a smart medical device having a screw with an integrated electronics package. [Figure 20A] This is a schematic diagram of a preliminary built-in configuration example of a smart medical device having a sheath-shaped screw, where the sheath-shaped screw is attached to the surface of the screw and has a pair of electrodes that connect to an electronics package via vias provided on the side wall of the screw. [Figure 20B] This is a schematic diagram of a preliminary built-in configuration example of a smart medical device having a sheath-shaped screw, where the sheath-shaped screw is attached to the surface of the screw and has a pair of electrodes that connect to an electronics package via vias provided on the side wall of the screw. [Figure 21A] This is a schematic diagram of a preliminary built-in configuration example of a smart medical device having a sheath-shaped screw, showing the sheath-shaped screw having four pin electrodes that connect to an electronics package via vias provided on the side wall of the screw. [Figure 21B] This is a schematic diagram of a preliminary built-in configuration example of a smart medical device having a sheath-shaped screw, showing the sheath-shaped screw having four pin electrodes that connect to an electronics package via vias provided on the side wall of the screw. [Figure 22A] This block diagram shows components of an implantable reporting processor (IRP), an example of a smart medical device having a sensor system for monitoring the healing status of a fracture site. [Figure 22B] This block diagram shows components of an implantable reporting processor (IRP), an example of a smart medical device having a sensor system for monitoring the healing status of a fracture site. [Figure 23] This graph shows the magnitude of impedance measured across the fracture site as a function of time using a smart medical device. [Figure 24A] A schematic diagram of a smart medical device implanted for a specific type of fracture. [Figure 24B]A schematic diagram of a smart medical device implanted for a different type of fracture. [Figure 24C] A schematic diagram of a smart medical device implanted for a different type of fracture. [Figure 24D] A schematic diagram of a smart medical device implanted for a different type of fracture. [Figure 24E] A schematic diagram of a smart medical device implanted for a different type of fracture. [Figure 25A] This is a flowchart illustrating a method for characterizing fracture sites using smart medical devices. [Figure 25B] This is a schematic diagram illustrating how to characterize a fracture site using smart medical devices. [Figure 26A] There is a flowchart illustrating another method for characterizing fracture sites using smart medical devices. [Figure 26B] This is a schematic diagram illustrating how to characterize a fracture site using smart medical devices. [Figure 27A] This is a flowchart illustrating another method for characterizing fracture sites using smart medical devices. [Figure 27B] This is a schematic diagram illustrating another way to characterize fracture sites using smart medical devices. [Figure 28] This is a diagram showing the setup of smart medical devices in the patient's home. [Modes for carrying out the invention]

[0026] The smart medical devices disclosed herein include electronics, such as application-specific integrated circuit (ASIC) chips including memory, a microprocessor, and a wireless telemetry element, a power supply (battery or supercapacitor), wireless and antenna environment tuning (MICS or Bluetooth®), sensors for verifying in vivo bone healing measurements, and sensors for detecting movement relative to a first placement location of the sensors. The smart medical devices are used, for example, in orthopedic trauma and spinal products, such as hip fracture screws, long bone fracture screws (together with plates), and spinal pedicle screws.

[0027] Two configuration examples of the smart medical device are envisioned. In this specification, one is referred to as the cartridge configuration example, and the other as the pre-built-in configuration example.

[0028] Cartridge configuration example Referring to Figures 1A to 1C, an example of a cartridge configuration for the smart medical device 100 has a structure 102 or outer body characterized by a tubular body with a lumen 104 that extends at least partially through it. The structure 102 is configured to be implanted at least partially inside the body. The medical device 100 further has an electronics cartridge 106 or inner body having electronics, such as an ASIC chip, power supply, antenna, etc. In some embodiments, the electronics cartridge 106 may have a shell housing the electronics. In other embodiments, the electronics may be fixed together or supported by a core element extending along the axis of the cartridge. The electronics cartridge 106 is configured to be inserted and fitted into the lumen 104 of the structure 102 after implantation of the structure.

[0029] In some embodiments, the structure 102 as a whole is made of a single biocompatible, implantable-grade material. Exemplary implantable-grade materials include titanium, stainless cobalt-chromium-molybdenum alloy, nitinol, ceramics, alumina-zirconia-carbon hydroxyapatite, or composites, such as carbon fiber-reinforced PEEK.

[0030] In some embodiments, the structure 102 may be segmented into different parts, each made of a combination of different materials. For example, the structure 102 may have a distal body, section, or section made of a metallic material, a central body, section, or section made of a different material than the distal section, and a proximal body, section, or section made of substantially the same metallic material as the distal section. In one exemplary configuration, the metallic materials of the distal and proximal sections may be implantable grade materials having a Young's modulus of 100-200 gigapascals (GPa) and tensile strength to allow homogeneous or heterogeneous material interactions, while the material of the central section may be made of the same material as the distal or proximal section, or a different implantable grade material, such as a polymer material, having the same or different Young's modulus. By providing a segmented structure 102, the different parts of the structure can exhibit different properties with respect to strength and performance for a particular application. For example, the materials used for different parts, whether these parts are made of different or similar materials, should be such that the strength of the materials allows the structure 102 to fit into and interlock with the fractured bone, and to pull the fractured area together for healing. A structure 102 configured in this way can assist the detection operation of a medical device 100. For example, it can assist in electrochemical impedance spectroscopy (EIS) measurements before and after the fracture site.

[0031] In configurations where the electronics cartridge 106 includes a shell or core element, the shell or core element is preferably formed of an implantable-grade material that is electrically insulating and non-conductive. In some embodiments, the electronics cartridge 106 is preferably configured to enhance the healing response at the implant site. For this purpose, the electronics cartridge 106 has a mechanism that delivers a catalytic material that generates a gaseous oxygen reaction and, through a chemical reaction, enhances the oxygen zone at the implant site. In some configurations, this mechanism is a reservoir that releases the catalytic material once or more after implantation under the control of a sustained-release controller. In other configurations, this mechanism is a coating of catalytic material added to the cartridge during the electrical processing of the cartridge. In any configuration, the material released by the cartridge mechanism generates an energy reaction that releases an oxygen-enriched environment into a local zone around the implant, thereby improving the healing process.

[0032] In the embodiments shown in Figures 1A to 1C, the structure 102 is a sheath screw configured to be implanted in bone tissue. In one configuration, the lumen 104 of the sheath screw 102 is configured to receive an implant tool during implantation of the screw 102 into bone tissue. In another configuration, the lumen 104 is preferably configured to receive a support element, such as a "blank" cartridge, that temporarily fills the lumen to provide support for the sheath screw 102, thereby reducing the risk of screw 102 fracture when the screw 102 is implanted in the bone.

[0033] Continuing to refer to Figures 1A to 1C, the sheath screw 102 has a shaft 118 with an outer diameter in the range of 4 millimeters or more, and a head 119. The length of the shaft 118 varies depending on the application of the medical device 100. For example, in the case of an application related to hip joint femoral head fractures, the length of the shaft 118 is preferably about 115 millimeters. The sheath screw 102 has a shaft 118, the shaft 118 has continuous threads 111 provided around a portion thereof, and these continuous threads 111 constitute the threaded portion 112 of the screw configured to fix the screw in bone. The lumen 104 has a shaft portion with an inner diameter and volume sized to receive an electronics cartridge 106. The electronics cartridge 106 has a proximal end 140, a distal end 142, a head 122 provided at the proximal end, and a shaft 126 extending from the head toward the distal end.

[0034] Each of the electronics cartridge 106 and the lumen 104 has a form factor that allows for the placement of the electronics cartridge 106 within the lumen 104. Referring to Figure 1B, in one embodiment, the form factor of the lumen 104 of the sheath screw 102 includes a head portion 120 and a shaft portion 124, where the inner diameter of the head portion is larger than the inner diameter of the shaft. The head portion 120 of the lumen 104 preferably corresponds to a recessed pocket provided in the head 119 of the sheath screw 102, for example, a polygonal head. The recessed pocket preferably receives the corresponding hexagonal head of the implant tool and is configured to transmit the torque applied to the implant tool to the screw during implantation of the instrument into the bone. Referring to Figure 1C, the form factor of the electronics cartridge 106 includes a head 122 and a shaft 126, where the outer diameter of the head 122 is larger than the outer diameter of the shaft 126.

[0035] In one embodiment, the electronics cartridge 106 is configured to be fixed within the lumen 104. In another embodiment, the electronics cartridge 106 is configured to be removed from the lumen without impairing the structural integrity of either the electronics cartridge or the structure.

[0036] For these purposes, various types of fixing mechanisms are conceivable. For example, referring to Figures 2A and 2B, the head 122 of the electronics cartridge 106 and the head portion 120 of the lumen 104 of the sheath screw 102 are preferably dimensioned relative to each other such that a friction fit 182 results when the cartridge is fully inserted into the lumen 104 of the screw. In this configuration example, the head 122 of the electronics cartridge 106 is preferably pressed into the head portion 120 of the lumen 104 of the sheath screw 102, for example, by hammering, to achieve the friction fit. In a variation of this configuration, the friction fit can be obtained based on the geometric shapes of the head portion 120 of the lumen 104 of the sheath screw 102 and the head 122 of the electronics cartridge 106. For example, the head portion 120 of the 104 lumen is preferably oval-shaped, and in order to obtain a friction fit between this head portion 120 and the head 119 of the sheath-shaped screw, it is best to rotate the cartridge head 122 by, for example, 1 / 4 turn.

[0037] Referring to Figures 3A and 3B, in another embodiment, the head 122 of the electronics cartridge 106 and the head portion 120 of the lumen 104 of the sheath screw 102 have complementary mechanical features, so that a mechanical coupling 184 is consequently created when the cartridge is fully inserted into the lumen 104 of the screw. In one configuration example, the mechanical feature of the electronics cartridge 106 is the toothed projection 186, and the mechanical feature of the sheath screw 102 is the enlarged ring region 188 of the head portion 120 of the lumen 104 of the screw. In this configuration example, the head 122 of the electronics cartridge 106 is preferably pressed into the head portion 120 of the lumen 104 of the sheath screw 102, until the toothed projection 186 clicks into place in the ring region 188, thereby establishing a mechanical connection 184 and holding the electronics cartridge 106 in place within the sheath screw by preventing the cartridge from moving outward from the sheath screw. In a modified version of this configuration example, a snap-fit ​​feature, such as a round or hexagonal ring, is preferably provided, which extends around the entire head 122 of the electronics cartridge 106 and snaps into place in the ring region 188.

[0038] Referring to Figure 4, in another embodiment, a section of the shaft 126 of the electronics cartridge 106 located below the head 122 has a threaded portion 190, which is configured to engage with a complementary threaded portion (not shown) provided on the lumen 104 of the sheath screw 102. In this configuration, the electronics cartridge 106 has a circular cross-section along its length. The lumen 104 of the sheath screw 102 also has a circular cross-section, thus allowing rotation of the electronics cartridge 106 and thread engagement of components 102 and 106 within the lumen 104. In this configuration, the electronics cartridge 106 can then be removed from the sheath screw 102 by loosening the sheath screw 102. In a modified version of this configuration, the complementary threads are preferably located on the outer wall of the head 122 of the electronics cartridge and on the inner wall of the head 119 of the sheath screw 102. In this configuration example, the head 119 of the sheath-shaped screw is located on its outer surface and is characterized by being coupled to the implant tool in such a way that the screw can rotate during implantation.

[0039] Referring to Figures 5A and 5B, in another embodiment, a section of the shaft 126 of the electronics cartridge 106 located below the head 122 has an interlock feature 192, which consists of a number of grooves arranged around the circumference of the shaft. In this configuration example, an adhesive is applied to the interlock feature 192 before inserting the electronics cartridge 106 into the lumen 104 of the sheath screw 102. The adhesive 194 is preferably, for example, polymethyl methacrylate (PMMA) or silicone. When the electronics cartridge 106 is fully inserted into the lumen 104 of the sheath screw 102, an adhesive interface 194 is formed between the interlock feature 192 and the inner wall 196 of the sheath screw 102.

[0040] Another possible fixing mechanism is a peel-off surface provided on the underside of the head 122 of the electronics cartridge 106, which, when peeled off, exposes an adhesive surface. When the electronics cartridge 106 is fully inserted into the lumen 104 of the sheath-shaped screw, the adhesive surface abuts against the bottom surface of the head portion 120 of the lumen, thereby fixing the electronics cartridge 106 in place.

[0041] Referring to Figures 1B and 1D, in some embodiments, the sheath screw 102 has an outer surface 113 and one or more electrodes 128, 130 located on this outer surface. The electrodes 128, 130 are preferably arc-shaped pad electrodes with a radius of curvature approximately the same as the radius of curvature of the shaft 118, and these electrodes preferably extend along grooves provided between adjacent windings of the threads 111 that constitute the threaded portion 112. For example, each electrode 128, 130 may extend over a range of 30° to 180° around the shaft 118. The electrodes 128, 130 are made of a conductive implantable grade material with low resistivity. Exemplary materials include platinum, platinum-iridium, gold, gold-plated copper, silver, or other low-resistivity materials used in electronic connection circuits. The electrodes 128, 130 are electrically insulated from the shaft 118 of the sheath screw 102. For this purpose, insulating material is preferably applied between the surfaces of electrodes 128 and 130, otherwise the surfaces of such electrodes would come into contact with the outer surface 113 of the shaft 118. A hermetically sealed feedthrough 115 is preferably extended through the side wall 117 of the sheathed screw 102, providing an electrical coupling between the electrodes 128 and 130 of the sheathed screw and the interior 121. The feedthrough 115 may be a conventional ceramic feedthrough with a gold-brazed conductor, a glass feedthrough, or a fired ceramic feedthrough.

[0042] Referring to Figure 1D, in embodiments having a partially threaded sheath-shaped screw 102, for example in the embodiments of Figures 1A to 1C, it is preferable that a layer of insulating material 174 is applied to the portion of the screw without threads (the non-threaded portion) to form a covering area. This material is preferably, for example, titanium dioxide or aluminum oxide applied to the non-threaded portion 172 using anodizing. The resistance of titanium dioxide is approximately the same as that of cobalt chrome oxide, which is an excellent insulator. The insulating material is preferably a diamond material applied to the non-threaded portion 172 using chemical vapor deposition, thereby obtaining a highly insulating film. This material may also be a ceramic material applied to the non-threaded portion 172 using chemical vapor deposition, thereby initiating film bonding, and this material is preferably a conductive or non-conductive metal liquid metal reflow produced by eutectic mounting.

[0043] To minimize coating shear, the smaller diameter of the threaded portion 112 of the sheath screw 102 is increased by an amount substantially equal to the thickness of the material layer 174. Thus, the outer diameter of the coated area of ​​the sheath screw 102 is, overall, equal to the smaller diameter of the threaded portion 112 of the sheath screw 102.

[0044] The electrodes 128 and 130, when combined with other electronics of the medical device 100, can constitute a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. Further details of the EIS sensor are disclosed below. The electrodes 128 and 130, when combined with other electronics of the medical device 100, can constitute a communication interface. Further details of the communication interface are disclosed below.

[0045] Referring to Figure 1C, in some embodiments, the electronics cartridge 106 has an outer surface and one or more electrical contacts 132, 134 provided on the outer surface and configured to electrically couple to one or more electrodes 128, 130 when the electronics cartridge is inserted into the lumen. An insulating seal 133 between the electrical contacts 132, 134 prevents harmful electrical contact between two electrodes 128, 130 or two electrical contacts 132, 134, even if the space between them is filled with a conductive fluid. The insulating seal 133 is preferably an O-ring or a conformable coated silicone wiper. Each of the sheath screw 102 and the electronics cartridge 106 has respective features for aligning one or more electrodes 128, 130 to one or more electrical contacts 132, 134 when the electronics cartridge is inserted into the lumen 104. These features are preferably complementary mechanical features, such as grooves provided on the surface of either the sheath-shaped screw 102 or the electronics cartridge 106, and projections extending from the other of the screw or the electronics cartridge.

[0046] Referring to Figures 1B and 6A-6C, the sheath-shaped screw 102 has a proximal end 136, a distal end 138, and one or more electrodes located along the shaft 118 between the proximal and distal ends. Different numbers and arrangements of electrodes are possible.

[0047] For example, referring to Figures 1B and 6A, in some configurations, the sheath screw 102 may have a single pair of spaced electrodes provided on the shaft 118, such as a distal electrode 130 located near the distal end 138 and a proximal electrode 128 located near the proximal end 136. In the configuration example in Figure 1B, electrodes 128 and 130 are positioned on the shaft 118 on either side of the threaded portion 112 of the sheath screw 102, and these electrodes are preferably spaced 20 to 30 mm or more apart. In the configuration in Figure 6A, each of electrodes 128 and 130 is positioned on the shaft 118 between adjacent winding portions of the threads 111 of the shaft, and these electrodes are preferably spaced 20 to 30 mm or more apart. The electrodes 128 and 130 are preferably arc-shaped pad electrodes having a radius of curvature approximately the same as that of the shaft 118, and these electrodes are preferably extending along the grooves between adjacent windings of the screw thread 111. For example, each electrode 128 and 130 is preferably extending around the shaft 118 over a range of 30° to 180°.

[0048] Referring to Figure 6B, in some embodiments, the sheath-shaped screw 102 preferably has two pairs of electrodes along the shaft 118. One pair of distal electrodes 130, 150 is positioned near the distal end 138, and one pair of proximal electrodes 128, 148 is positioned near the proximal end 136. In one configuration example, the electrodes 128, 130, 148, 150 are preferably positioned between adjacent windings of the threads 111 of the shaft 118. The pairs of electrodes 128, 130, 148, 150 are preferably separated from each other by a distance of 2 to 10 mm, and the pairs of electrodes are preferably separated from each other by a distance of 20 to 30 mm or more. Electrodes 128, 130, 148, and 150 are preferably arc-shaped pad electrodes having a radius of curvature approximately the same as that of the shaft 118, and these electrodes are preferably extending along the grooves between adjacent windings of the screw thread 111. For example, each electrode 128, 130, 148, and 150 is preferably extending around the shaft 118 over a range of 30° to 180°.

[0049] Referring to Figure 6C, in some embodiments, the sheath-shaped screw 102 preferably has electrodes 164 arranged in an array along the shaft 118 between the distal end 138 and the proximal end 136 of the sheath-shaped screw 102. In one configuration example, each electrode belonging to the electrode array 164 is preferably positioned between adjacent windings of the threads 111 provided on the shaft 118, and these electrodes are preferably spaced 2 to 10 mm apart from each other. The electrodes belonging to the electrode array 164 are preferably arc-shaped pad electrodes having a radius of curvature approximately the same as the radius of curvature of the shaft 118, and these electrodes preferably extend along the grooves between adjacent windings of the threads 111. For example, each electrode in the electrode array 164 may extend over a range of 30° to 180° around the shaft 118.

[0050] Referring to the schematic diagrams in Figures 7A and 7B, in an example configuration of a medical device 100 having only one pair of electrodes 128, 130, these electrodes are electrically insulated from each other. For example, the shaft 118 extending between the proximal end 136 and distal end 138 of the sheath screw 102 may be formed of an electrically non-conductive material or may be covered with an insulating material. In either case, one or more electrodes 128, 130 are separated by insulating regions 152. Additional insulating regions 155, 156 located on the sides of electrodes 128, 130 electrically insulate the electrodes 128, 130 from the surface of the sheath screw 102, which is preferably conductive.

[0051] Referring to the schematic diagrams in Figures 8A and 8B, in an example configuration of a medical device 100 having electrodes 164 arranged in an array, these electrodes are electrically insulated from each other. For example, the shaft 118 extending between the proximal end 136 and distal end 138 of the sheath-shaped screw 102 may be formed of an electrically non-conductive material or may be covered with an insulating material. In either case, one or more electrodes 128,130 are separated by an insulating region 158.

[0052] Referring to Figures 1C, 7B, and 8B, as described above, the electronics cartridge 106 has a proximal end 140, a distal end 142, a head 122 located at the proximal end, and a shaft 126 extending from the head toward the distal end. The electronics cartridge 106 is configured to electrically couple the electrodes 128, 130, 148, 150, and 164 of the sheath-shaped screw 102 to the electronics housed within the cartridge.

[0053] For this purpose, referring to Figures 1C and 7B, in some embodiments, the electronics cartridge 106 has an outer surface and a pair of electrical contacts 132, 134 located on this outer surface, configured to electrically couple to a pair of electrodes 128, 130 of the sheath screw when the electronics cartridge is inserted into the lumen of the sheath screw. The pair of electrical contacts 132, 134 penetrate the wall of the shell of the electronics cartridge 106 and electrically couple to the electronics inside the cartridge. As mentioned above, the shell is made of a non-conductive material. Therefore, the pair of electrical contacts 132, 134 are electrically insulated from each other.

[0054] Referring to Figure 8B, in some embodiments, the electronics cartridge 106 has an outer surface and an array of electrical contacts 166 located on this outer surface, configured to electrically couple to an array of electrodes 164 when the electronics cartridge is inserted into the lumen of a sheath-shaped screw. Each electrical contact 166 included in the array of electrical contacts penetrates the wall of the shell of the electronics cartridge 106 and electrically couples to the electronics within the cartridge. As mentioned above, the shell is made of a non-conductive material. Therefore, the electrical contacts 166 are electrically insulated from one another.

[0055] Referring to Figures 1C, 7B, and 8B, the electronics contained in the electronics cartridge 106 are preferably associated with one or more electronic assemblies located in either or both of the head 122 and the shaft 126. The electronics of the electronics cartridge 106 have an implanted reporting processor (IRP), details of such an IRP are further given below with reference to Figures 22A and 22B. With respect to the structure of the IRP, in some embodiments the IRP has one or more antennas 144, 145, one or more rechargeable power supplies 154, and one or more electronic assemblies, such electronic assemblies are A communication circuit system that enables communication between a device and another device or apparatus (either implanted inside or outside the body). One or more sensors that can be used to perform one or more of the following actions, namely: 1) detecting, measuring and / or monitoring one or more different aspects of body tissue (anatomical structure, physiology, metabolism, and / or function); 2) detecting, measuring and / or monitoring one or more aspects of the state or function of the body or body segment / joint (including fracture healing, movement including measurement of position, angle, velocity, and acceleration of body segments and joints); and / or 3) detecting, measuring and / or monitoring one or more aspects of orthopedic instruments or implants. This includes various other components that enable the operation of the medical device 100, such as memory, switches, and processors.

[0056] The electronics are positioned within the electronics cartridge 106 to minimize the load on the electronic components, such as particularly sensitive electronics such as processors, CPUs, communication circuits, and ASICs, or power sources such as capacitors, batteries, or rechargeable batteries. For this purpose, the electronics are generally positioned away from the high-stress zones of the medical device 100, and in areas where the load on the device is minimal. For example, in the case of a medical device 100 used to treat fractures, the high-stress zones include a) the interface change from the head to the shaft body due to torque load and compression during implantation, b) the diametrical change and the distal transition from the threads to the shaft body due to torque load and compression during implantation, and c) the center of the shaft body due to torque, moment, and axial stress concentration within this zone. In addition, highly sensitive electronics, such as processors, CPUs, communication circuits, and ASICs, are located at the proximal end of the electronics cartridge 106, while less sensitive electronics, such as the power supply 154, are located in the middle region of the cartridge. In some embodiments, the electronics are preferably located in the high-stress region of the medical device 100, and are preferably configured to withstand stress by being flexible, for example, to allow a certain degree of deformation under the load conditions of the device.

[0057] In applications requiring multiple medical devices, it is preferable that the smart medical device 100 be selected to be located at the least stressful implantation site, i.e., the location where the implanted medical implant experiences the least stress. For example, in the case of medical device 100 used when treating a femoral neck fracture using the inverted triangle approach shown in Figure 24B, the least stressed location corresponds to one vertex of the inverted triangle. Therefore, medical device 100 is best positioned at one vertex of the inverted triangle, where it primarily performs a characterizing function that characterizes the fracture site and its healing process. Medical devices that perform a stabilizing function, either overall or primarily, may optionally lack sensors and are best positioned elsewhere in the inverted triangle, their purpose being to firmly hold the bone tissue together during healing.

[0058] Thus, in one view, the Disclosure provides a set of medical devices, namely at least two medical devices, optionally three, four, five, etc., used together to treat a fracture site in bone tissue. In one embodiment, all medical devices belonging to the set are screws. In particular, if the medical devices of the Disclosure are intended to provide little to no stabilization function, the medical devices of the Disclosure are preferably used in conjunction with other medical devices, such as standard orthopedic screws that do not have sensors and primarily provide stabilization function to healing tissue. Thus, in one view, the Disclosure provides a set of medical devices, in which at least one component belonging to the set is a smart medical device of the Disclosure that provides a characterizing function (and optionally some stabilization function), and at least one component belonging to this set is used to provide primarily or exclusively a stabilization function (and optionally no characterizing function). For example, from one perspective, the Disclosure provides a set of three medical devices, in which one component of the set is a smart medical device of the Disclosure that performs a characterizing function (and optionally some stabilizing function), and the other two components of this set are used primarily or exclusively to perform stabilizing functions, in which case each of the medical devices is optionally a screw. Thus, in use, the smart medical device of the Disclosure is preferably placed in the bone tissue in a location where stabilizing function is not so necessary, i.e., in a location where there is no load or only a small load. The medical devices constituting the set that are used primarily or exclusively to provide stabilizing functions are preferably placed in a location in the bone tissue where there is a relatively large load. Thus, in one embodiment, the Disclosure provides a method for treating a femoral neck fracture in an inverted triangle configuration, the method comprising the steps of placing a medical device of the Disclosure, for example, medical device 100, at one vertex of an inverted triangle, and placing medical devices without sensors at the other two vertices of the triangle.

[0059] In one view, the present disclosure provides a set of medical devices, the set comprising at least one first medical device of the present disclosure, and the set comprising at least one second medical device configured to be insertable into bone tissue, wherein the second medical device does not comprise a sensor. Optionally, each of the first and second medical devices is a screw. Optionally, the set comprises a single, i.e., just one, first medical device and a plurality, i.e., two or more, i.e., three or more, second medical devices, wherein, optionally, each component of the set is a screw.

[0060] With respect to one or more antennas 144, 145 of the electronics cartridge 106, in some embodiments, the antenna 144 is preferably located entirely inside the cartridge, and this antenna is preferably located within the head 122 of the cartridge, within the shaft 126 of the cartridge, or partially within the head and partially within the shaft. For example, referring to Figure 9A, the head 122a of the electronics cartridge 106 preferably has an antenna 144a enclosed in a material 147 such as PEEK. The antenna 144a is preferably a conductive wire 146 or trace line extending along an antenna board 149 parallel to the base 151 of the head 122. Referring to Figure 9B, in another embodiment of the electronics cartridge 106, an antenna 144b configured to function as both a communication antenna and a charging element is preferably located at the top of the head 122b. The antenna 144b is preferably configured as a protruding pin arranged in a multifaceted array.

[0061] Referring to Figure 1C, in another embodiment of the electronics cartridge 106, the antenna 145 is associated with the shaft 126. The antenna 145 may consist of a conductive wire or trace wire that is wound around the shaft 126 and extends along a portion of the shaft 126. For example, the antenna 145 may be a wire that extends in a spiral pattern around the shaft 126. The antenna 145 is embedded in the shaft and thus electrically insulated from the outer surface of the shaft 126 to avoid contact with the inside of the sheathed screw 102 when the electronics cartridge 106 is inserted into the lumen 104 of the screw. The antenna 145 may be connected to the electronics in the head 122 via an insulated trace wire or wire that extends along the shaft 126 between the antenna and the head.

[0062] In some embodiments, the antenna is preferably located entirely outside the cartridge. In some embodiments, the antenna is preferably located partially inside the cartridge and partially outside the cartridge.

[0063] With respect to one or more power sources 154 of the electronics cartridge 106, referring to Figures 7B and 8B, the power sources 154 are preferably associated with the shaft 126 of the electronics cartridge 106 and preferably located in an intermediate region along the length of the shaft for the purpose of structural stability. The one or more power sources 154 are preferably rechargeable, and a recharging mechanism, such as a coil, is preferably located within the head of the electronics cartridge 106. In other embodiments (not shown), the power source is preferably associated with the head 122 of the electronics cartridge 106, and a recharging mechanism, such as a coil, is preferably provided simultaneously with a battery in the head of the electronics cartridge. As will be further described below, the one or more power sources 154 are preferably one or more of a battery, such as a rechargeable battery, and a capacitor, such as a supercapacitor. The electronics may include an energy extraction device configured to extract energy by one of electrostatic energy, wireless energy transmission, and IR radiation.

[0064] With respect to the communication circuitry of the electronics cartridge 106, in one embodiment, one or more communication components include a radio frequency (RF) transceiver configured to be coupled to antennas 144, 145 and to transmit and receive RF signals (e.g., via Bluetooth or MICS). Referring to Figure 9A, the RF transceiver is preferably associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the RF transceiver is preferably associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126. Further details of RF telemetry communication are described below with reference to Figure 22A.

[0065] In another embodiment, one or more communication components include a positioned tissue-conductive communication circuit system, which is coupled to a pair of electrodes associated with the medical device 100 and positioned to be in contact with tissue. The tissue-conductive communication circuit system preferably includes a transmitter and a receiver. The pair of electrodes preferably correspond to electrodes 128, 130 of the medical device 100. In this configuration, one or more communication components preferably are configured to enable capacitive coupling between the medical device 100 and another device, or to enable galvanic coupling between the medical device and another device. Referring to Figure 9A, the tissue-conductive communication circuit system preferably relates to an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the tissue-conductive communication circuit system preferably relates to an electronics assembly 157 in the form of a circuit capsule located within the shaft 126. Details of capacitive and galvanic coupled communication are further described below with reference to Figure 22A.

[0066] With respect to the sensors of the electronics cartridge 106, in some embodiments, one or more sensors include an EIS sensor consisting of electrodes 128, 130 of the medical device in combination with electrode switches and detection circuitry / modules of the medical device 100. Referring to Figure 9A, the electrode switches and detection circuitry / modules are preferably associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the electrode switches and detection circuitry / modules are preferably associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126. Further details of the EIS sensor are disclosed below with reference to Figures 22A and 22B.

[0067] In some embodiments, one or more sensors may include an inertial measuring unit (IMU), such as an accelerometer or gyroscope, configured to output signals corresponding to the movement of the medical device 100, and, by relevance, the movement of the bone structure in which the device is implanted, and the movement or activity level of the patient in whom the device is implanted. The accelerometer may be a one-dimensional accelerometer, a two-dimensional accelerometer, a three-dimensional accelerometer, or an accelerometer of any available dimension. The electronics may further include a processor coupled to the accelerometer to receive and process signals, and configured to provide the signals as one or more indicators of the patient's activity level, the integrity (fracture) of the medical device, and the movement of the medical device relative to the implantation site (back-out movement). For example, the position of the accelerometer may be determined after implantation, and by using the detection of changes in that position, the movement of the medical device at the implantation site can be detected. Referring to Figure 9A, the accelerometer or gyroscope and the processor may be associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the accelerometer or gyroscope and processor are preferably associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126.

[0068] In some embodiments, one or more sensors may include a strain sensor associated with the medical device 100. The electronics may further include a processor coupled to the strain sensor to receive and process signals, and configured to provide one or more indicators of the integrity of the medical device (fracture) and the movement of the medical device relative to the implant placement site (retraction movement or an indicator of fracture healing). Referring to Figure 9A, the strain sensor and processor may be associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the strain sensor and processor may be associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126.

[0069] In some embodiments, one or more sensors may include an acoustic resonance sensor configured to be associated with the medical device 100 and to output a signal corresponding to the level of acoustic vibration / motion of the medical device. The electronics may further include a processor coupled to the acoustic resonance device to receive the signal and configured to process the signal to provide an indicator of the degree of fixation of the medical device within the bone structure at the implantation site, the processor of which may provide an indicator of the state of bone healing. The acoustic resonance sensor may be a single device that is associated with the medical device 100 and vibrates, or it may be a pair of devices consisting of an acoustic transmitter provided at one end of the medical device 100 and an acoustic receiver provided at the other end of the device. The acoustic transmitter outputs an acoustic signal into the medical device 100. The acoustic receiver detects the acoustic signal and outputs an electrical signal having an amplitude representing the intensity of the acoustic signal received by the acoustic receiver. The processor can analyze this amplitude to calculate the state of bone healing, in which case the progression of the acoustic signal over time toward a smaller amplitude (meaning that the vibration of the medical device is small) represents bone healing. Referring to Figure 9A, the acoustic resonance sensor and processor are preferably associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the acoustic resonance sensor and processor are preferably associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126.

[0070] In some embodiments, one or more sensors may include a stress sensor associated with the medical device 100 and configured to output a signal corresponding to the level of stress within the medical device. The electronics may further include a processor coupled to the stress sensor to receive this signal and configured to process this signal to provide an indicator of the degree of fixation of the medical device within the bone structure at the implantation site, the processor of which may provide an indicator of the bone healing state. The stress sensor may be a single device associated with the medical device 100 that detects local stress, or it may be a device consisting of stress sensors located within or on the medical device 100. The stress sensor detects mechanical stress in a section of the medical device 100 and outputs an electrical signal having an amplitude representing the magnitude of this stress. The processor analyzes this amplitude to calculate the state of fracture healing, in which case the progression of stress over time toward a small amplitude (meaning small vibration of the medical device) represents bone healing. Referring to Figure 9A, the stress sensor and processor may be associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the stress sensor and processor are preferably associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126.

[0071] In some embodiments, one or more sensors may include a temperature sensor configured to output a signal corresponding to the temperature of the medical device 100 at the implantation site. Referring to Figure 9A, the temperature sensor and processor may be associated with an electronics assembly 153 in the form of a circuit board located within the head 122a. Referring to Figure 9B, the temperature sensor and processor may be associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126. In some embodiments, the temperature sensor may be associated with a sheath-shaped screw 102.

[0072] Referring to Figure 9A, the electronics within the head 122a may further include other components associated with an electronics assembly 153 in the form of a circuit board located beneath the antenna board 149, such as memory, power switches, fuses, etc. The electronics within the head 122a may further include battery contacts 195 extending to a power source (not shown) located within the shaft 126 of the electronics cartridge 106. In other embodiments, some of the electronics may be mounted on a printed circuit board located within the shaft 126. Referring to Figure 9B, the electronics within the shaft 126 may include a power source 154 and other components associated with an electronics assembly 157 in the form of a circuit capsule located within the shaft 126, such as memory, power switches, fuses, etc. Details of these components are further disclosed below with reference to Figure 22A.

[0073] In some embodiments, the electronic cartridge 106 includes a mechanism configured to deliver a catalytic material that generates a gaseous oxygen reaction at the implantation site through a chemical reaction. This mechanism is a reservoir that releases the catalytic material one or more times after implantation under the control of a sustained-release controller of the processor. Preferably, this mechanism is a coating of catalytic material applied to the cartridge that passively dissolves into the body. The reaction between the catalytic material and the body can be facilitated by delivering electrical stimulation to electrodes of the medical device.

[0074] Referring to Figures 10A and 10B, in some embodiments, the cartridge configuration of the smart medical device 1000 includes a sheath-like structure 1002 through which a lumen 1004 extends, and a plurality of electrodes 1028, 1030 provided on the outer surface of the structure. As in other embodiments of the medical device, the sheath-like structure 1002 is configured to be at least partially implanted in the body. The medical device 1000 further includes an electronics cartridge 1006 containing electronics. The electronics cartridge 1006 is configured to be insertable into the lumen 1004 of the sheath-like structure 1002. When inserted, the electronics cartridge 1006 provides one or more electrical connections 1008, 1010 between the cartridge's electronics and the plurality of electrodes 1028, 1030.

[0075] The sheath-shaped structure 1002 has a conductive substrate 1012 with a threaded portion 1011. The electronics cartridge 1006 has a first electrical contact 1016 and a second electrical contact 1022. The first electrical contact 1016 contacts the inner surface of the conductive substrate 1012 and is positioned to realize an electrical coupling 1010 between the electronics and the first electrode 1030. The second electrical contact 1022 contacts a portion of the second electrode 1028 and is positioned to realize an electrical coupling 1008 between the electronics and the second electrode 1028.

[0076] The outer surface of the conductive substrate 1012 is at least partially treated or coated with an insulating material 1014. For example, the titanium conductive substrate 1012 may be anodized to electrically insulate its surface. The first electrode 1030 of the plurality of electrodes corresponds to the exposed portion of the conductive substrate 1012 connected to the electronics cartridge 1006 via the first electrical contact 1016 of the cartridge. The first electrical contact 1016 may be, for example, a leaf spring, a pressure-fitted metal ring, or a contact metal surface. The surface of the first electrode 1030 and the surface in contact with the first electrical contact 1016 are not surface-treated or coated. This allows for electrical connection to the electronics cartridge 1006 via the conductive substrate 1012.

[0077] The second electrode 1028 of the multiple electrodes is located on a portion of the insulating material 1014 at the proximal end of the sheath-shaped structure 1002 and is connected to the electronics cartridge 1006 via the second electrical contact 1022 of the electronics cartridge 1006. The second electrical contact 1022 may be, for example, a leaf spring, a pressure-fitted metal ring, or a contact metal surface.

[0078] The second electrode 1028 is constructed by coating or treating the conductive substrate 1012 to form a conductive surface layer 1018 on the top of the insulating material 1014. The coating forming the conductive surface layer 1018 is thin so as to maintain the strength of the sheath-like structure 1002 and maintain approximately the same outer diameter as a conventional sheath-like structure. Electrical contact with the patient outside the area of ​​the second electrode 1028 is prevented by a thin insulating treatment or coating 1020 and / or by slightly reducing the diameter of the sheath-like structure 1002 within one area of ​​the second electrode to reduce contact with the bone. The insulating treatment or coating 1020 may be added by several processes, such as chemical vapor deposition, electroplating, silk screening, or powder coating. In this embodiment, the conductive surface layer 1018 wraps around the insulating head of the conductive substrate 1012 and covers the inside of the drive socket 1026.

[0079] The two electrical contacts 1016 and 1022 of the electronics cartridge 1006 are separated from each other by an insulating seal 1032. The insulating seal 1032 prevents harmful electrical contact between the two electrodes 1028 and 1030 or between the two electrical contacts 1016 and 1022, even if the space between them is filled with conductive fluid. The insulating seal 1032 is preferably an O-ring or a responsive overmolded silicone wiper. The second electrode 1028 is preferably protected from wear during insertion by a sacrificial anti-friction coating. The second electrode 1028 is also preferably mechanically protected by placing conductive and insulating coatings within recessed channels cut into the screw wall. This configuration technique allows for any arrangement, shape, and dimensions of the electrodes.

[0080] The embodiments in Figures 10A and 10B employ layers or coatings of insulating nonconductive material 1014 and conductive material 1018 to create multiple electrodes 1028, 1030 without altering the conductive substrate 1012 of the sheath-like structure 1002. Using masking, the coatings can be applied along the length of the sheath-like structure 1002 to create electrodes of various dimensions, thus creating electrodes that are different from each other. One area of ​​the conductive substrate 1012 acts as one electrode.

[0081] Referring to Figures 11A and 11B, in some embodiments, the cartridge configuration of the smart medical device 1100 includes a sheath-like structure 1102 through which a lumen 1104 extends, and a plurality of electrodes 1128, 1130, 1136, 1140 provided on the outer surface of this structure, each electrode having corresponding electrical contacts 1134, 1138, 1142, 1144 also provided on the outer surface of the structure. As in other embodiments of the medical device, the sheath-like structure 1102 is configured to be at least partially implanted in the body. The medical device 1100 further includes an electronics cartridge 1106 containing electronics. The electronics cartridge 1106 is configured to be inserted into the lumen 1104 of the sheath-like structure 1102. Upon insertion, the electronics cartridge 1106 establishes one or more electrical connections (not shown) between the cartridge's electronics and the multiple electrodes 1128, 1130, 1136, and 1140.

[0082] The electronics cartridge 1106 has multiple electrodes 1128, 1130, 1136, 1140 and multiple electrical contacts 1131, 1135, 1139, 1143. Each of the electrical contacts 1131, 1135, 1139, 1143 of the electronics cartridge 1106 is positioned to contact correspondingly with each of the electrical contacts 1134, 1138, 1142, 1144 of the sheath-shaped screw 1102 when inserted into the lumen 1104, thereby creating an electrical connection between the cartridge's electronics and the electrodes 1128, 1130, 1136, 1140. The electrical contacts 1131, 1135, 1139, 1143 of the electronics cartridge 1106 are preferably, for example, leaf springs, pressure-fitted metal rings, or contact metal surfaces.

[0083] The sheath-like structure 1102 has a conductive substrate having an outer surface that is at least partially treated or coated with an insulating material 1114. For example, the sheath-like structure 1102 may have a titanium substrate that is anodized to electrically insulate this outer surface. Multiple electrodes, for example four in the embodiment of Figure 11, are formed by a conductive coating applied on the insulating material 1114. Trace lines 1129, 1133, 1137, 1141 formed by this or the conductive coating extend from each electrode 1128, 1130, 1136, 1140 to a notch formed in the head 1119 of the sheath-like structure 1102, where the trace lines terminate at the respective electrical contacts 1134, 1138, 1142, 1144. The insulating coating covers the portions of the trace lines 1129, 1133, 1137, and 1141 that extend between the corresponding electrodes 1128, 1130, 1136, and 1140 of the sheath-shaped structure 1102 and the corresponding electrical contacts 1134, 1138, 1142, and 1144.

[0084] Three of the four electrodes, 1128, 1132, and 1136, are C-shaped and do not completely wrap around the shaft 1126 of the sheath-like structure 1002. This allows one or more of the trace lines 1133, 1137, and 1141 of the three more distal electrodes 1130, 1136, and 1140 to pass through the gaps of the C-shaped electrodes 1128, 1130, and 1136 on a single conductive layer. However, by adding an additional insulating layer, all four electrodes 1128, 1132, 1136, and 1140 can be completely wrapped around the shaft 1126 and cross over the tops of the conductive connections to the other electrodes.

[0085] Embodiments in Figures 11A and 11B utilize electroplating on conductive and nonconductive materials on the outer surface of the substrate of the sheath-shaped structure 1102. Firstly, the nonconductive layer insulates most or all of the substrate. Secondly, the substrate is covered and a conductive coating is applied to create electrical contacts 1134, 1138, 1142, 1144, electrical trace lines 1129, 1133, 1137, 1141, and electrodes 1128, 1130, 1136, 1140. Thirdly, nonconductive plating is applied only to the electrical trace lines 1129, 1133, 1137, 1141, thereby exposing the electrical contacts 1134, 1138, 1142, 1144 and electrodes 1128, 1130, 1136, 1140.

[0086] Referring to Figures 12A to 12C, in some embodiments, the cartridge concept of the smart medical device 1200 has a multi-component sheath-like structure 1202 through which a lumen 1204 extends, and a plurality of electrodes 1228, 1230 provided on the outer surface of this structure. As in other embodiments of the medical device, the sheath-like structure 1202 is configured to be at least partially implanted in the body. The medical device 1200 further has an electronics cartridge 1206 containing electronics. The electronics cartridge 1206 is configured to be insertable into the lumen 1204 of the multi-component sheath-like structure 1202. When inserted, the electronics cartridge 1206 provides one or more electrical connections 1208, 1210 between the cartridge's electronics and the plurality of electrodes 1228, 1230.

[0087] The multi-component sheath-like structure 1202 has a distal component 1212 and a proximal component 1214, each component having conductive substrates 1216a, 1216b having an outer surface at least partially covered with an insulating coating 1218. For example, the distal component 1212 and the proximal component 1214 may have titanium substrates 1216a, 1216b that are anodized to insulate their outer surfaces. The distal component 1212 has a threaded portion 1220. The multi-component sheath-like structure 1202 described herein has two components 1212, 1214, each having electrodes 1228, 1230, but the sheath-like structure 1202 may have three or more components. For example, the multi-component sheath-like structure may have four components, each having an electrode and each configured to be coupled to one or more adjacent components.

[0088] The electronics cartridge 1206 has a shell 1240 housing the electronics, and a first electrical contact 1222 and a second electrical contact 1224 located outside the shell and coupled to the electronics. The shell 1240 is configured to electrically insulate the two electrical contacts 1222 and 1224 from each other. For this purpose, the shell 1240 may be made of an electrically non-conductive material or of a conductive material coated with an insulating material. The first electrical contact 1222 is positioned to contact the inner surface of the conductive substrate 1216a of the distal component 1212, thereby creating an electrical coupling 1208 between the electronics and the first electrode 1230. The first electrical contact 1222 may be, for example, a leaf spring, a pressure-fitted metal ring, or a contact metal surface. The inner surface of the conductive substrate 1216a is not surface-treated or coated. This enables an electrical connection from the first electrode 1230 to the electronics cartridge 1206 via the conductive substrate 1216a. The second electrical contact 1224 is positioned to contact the inner surface of the conductive substrate 1216b of the proximal component 1214, thereby creating an electrical coupling 1210 between the electronics and the second electrode 1228. The second electrical contact 1224 may be, for example, a leaf spring, a pressure-fitted metal ring, or a contact metal surface. The inner surface of the conductive substrate 1216b is not surface-treated or coated. This enables an electrical connection from the second electrode 1228 to the electronics cartridge 1206 via the conductive substrate 1216b.

[0089] The first electrode 1230 and the second electrode 1228 correspond to the exposed areas of the corresponding conductive substrates 1216a and 1216b, respectively. The electrodes 1228 and 1230 may be constructed by covering the outer surfaces of the corresponding conductive substrates 1216a and 1216b before applying the insulating coating 1218, or, if the coating is already applied, by mechanically surface finishing the conductive substrate to remove the insulating coating. The first electrode 1230 and the second electrode 1228 are electrically insulated from each other by a non-conductive junction 1232 between the distal part 1212 and the proximal part 1214 of the sheath-like structure 1202.

[0090] The non-conductive joint 1232 is preferably an adhesive used to fix the proximal component 1214 to the distal component 1212 during the implantation of the medical device 1200. For example, during the implantation of the medical device 1200, the first component 1212 is first implanted in a portal socket made by penetrating the bone tissue. Next, a non-conductive adhesive material is applied to the end of the proximal component 1214, then this component is inserted into the portal socket, and finally this component is mechanically bonded to the distal component 1212. The bonding of the distal component 1212 and the proximal component 1214 is preferably achieved by the respective mechanical features 1234, 1236 of these components, for example, notches and projections that form each pair that fit together. Next, the electronics cartridge 1206 is inserted into the lumen 1204 by passing it through the head 1238 of the proximal component 1214. In another implantation procedure, the electronics cartridge 1206 is inserted into the distal component 1212, and then the proximal component 1214 is connected to the distal component. In yet another procedure, the distal component 1212 and the proximal component 1214 are assembled together outside the body, then implanted, and then seated in the bone using any of the implant tools and techniques described below with reference to Figures 18A to 18J. Next, the electronics cartridge 1206 is inserted into the assembled sheath-like structure 1202.

[0091] Referring to Figures 13A to 13D, in some embodiments, the cartridge configuration example of the smart medical device 1300 has a sheath screw 1302 and an electronics cartridge 1306 configured to be insertable into the sheath screw. In this embodiment, the electronics cartridge 1306 has one or more electrodes, and the sheath screw 1302 has one or more holes. In some embodiments, the various electronics of the electronics cartridge 1306 are located within the cartridge head 1322, and the power supply source 1354 is located within a portion of the shaft 1326 of the electronics cartridge, which is located below the head. This structure and characteristics of the sheath screw 1302 and the electronics cartridge 1306, as well as other structures and characteristics, are substantially identical to those described above for the sheath screw 102 and the electronics cartridge 106 in the embodiments of Figures 1A to 1C. Therefore, such details will not be repeated here. Instead, further description of the smart medical device 1300 in Figures 13A to 13D will focus on its distinct features.

[0092] Referring to Figure 13C, the sheath screw 1302 has a slot-shaped hole 1308 that penetrates its side wall 1310. The slot 1308 is located within a region of the shaft 1318 of the sheath screw 1302, proximal to the threaded region 1312 of the sheath screw 1302. In some embodiments, an insulating coating is applied to the outer surface 1316 of the sheath screw 1302 within a region of the slot 1308.

[0093] Referring to Figure 13D, the electronics cartridge 1306 has a spring-compressed electrode assembly 1314 extending radially outward from the surface of the cartridge shaft 1326. For this purpose, the electrode assembly 1314 is biased relative to the surface of the shaft 1326, thereby allowing the electronics cartridge to transition between a compressed state in which the outer surface of the electrode assembly 1314 is substantially coplanar with the surface of the shaft 1326 and an expanded state in which the outer surface of the electrode assembly 1314 is positioned above or offset relative to the surface of the shaft 1326 so as to penetrate the slot 1308. The electrode assembly 1314 has a pair of electrodes 1328, 1330 spaced at a distance of at least 1 mm from each other.

[0094] Continuing to refer to Figure 13D, the shape factors of the electrode assembly 1314, such as its geometric cross-section and thickness, as well as the distance d between the bottom of the head 1322 of the electronics cartridge 1306 and the top of the electrode projection, are such that when the electronics cartridge is fully inserted into the lumen 1304 of the sheath screw 1302, the electrode assembly 1314 aligns with the slot 1308 and penetrates it, positioning the electrodes 1328 and 1330 outward from the outer surface 1316 of the sheath screw.

[0095] The sheath-shaped screw 1302 and the electronics cartridge 1306 are similar to the mechanisms described above, with reference to Figures 2A to 5B, and preferably have one or more mechanisms for securing the cartridge within the screw. Furthermore, passing the electrode assembly 1314 through the slot 1308 also helps to secure the electronics cartridge 1306 within the sheath-shaped screw 1302.

[0096] Referring to Figures 13A to 13D, when implanting the medical device 1300 for the treatment of the fracture site 1342, the sheath screw 1302 is preferably implanted across the fracture site so that the fracture site is located between the opposite ends of the slot 1308, preferably midway between such ends. Therefore, when the electronics cartridge 1306 is inserted into the sheath screw 1302, the electrodes 1328 and 1330 are located on opposite sides of the fracture site 1342.

[0097] Electrodes 1328 and 1330, in combination with other electronics of the medical device 1300, can constitute a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. As further described below, in this configuration, the medical device 1300 enables the collection of data via electrodes 1328 and 1330 for the purpose of characterizing the fracture 1342 and analyzing the healing status. Electrodes 1328 and 1330, in combination with other electronics of the medical device 1300, can constitute a tissue conduction communication interface. Details of the tissue conduction communication interface are further disclosed below.

[0098] Referring to Figures 14A to 14D, in some embodiments, the cartridge configuration of the smart medical device 1400 includes a sheath screw 1402 and an electronics cartridge 1406 configured to be insertable into the sheath screw. In some configurations, the various electronics of the electronics cartridge 1406 are located within the cartridge head 1422, and the power source 1454 is located within a portion of the shaft 1426 of the electronics cartridge, below the head. This structure and characteristics of the sheath screw 1402 and the electronics cartridge 1406, as well as other structures and characteristics, are substantially identical to those described above for the sheath screw 102 and the electronics cartridge 106 in the embodiments of Figures 1A to 1C. Therefore, such details will not be repeated here. Instead, further description of the smart medical device 1400 in Figures 14A to 14D will focus on its distinct features.

[0099] Referring to Figure 14C, the sheath screw 1402 has an array of holes 1408 that penetrate its side wall 1410. In the sheath screw 1402 of Figure 14C, the array of holes 1408 has eight individual holes. The array of holes 1408 is located within a region of the shaft 1418 of the sheath screw 1402, proximal to the threaded region 1412 of the sheath screw 1402. In some embodiments, an insulating coating is applied to the outer surface 1416 of the sheath screw 1402 within a region of the array of holes 1408. In some embodiments, the insulating coating is applied to the outer surface 1416 of the sheath screw 1402 along its entire length, excluding the threaded region 1412.

[0100] Referring to Figure 14D, the electronics cartridge 1406 has an array of electrodes 1414. In the electronics cartridge 1406 of Figure 14D, the array of electrodes 1414 has eight individual electrodes. The array of electrodes 1414 includes a number of individual electrodes separated from each other by seals 1424 that seal and electrically insulate the individual electrodes from one another. In some embodiments, these seals 1424 correspond to a region of the hollow shell of the electronics cartridge 1406, which is formed of an insulating material as described above. In other embodiments, the seals 1424 may be a ring made of a non-conductive metal or polymer material or a biocompatible elastomer arranged around the shell of the electronics cartridge 1406. The distance between adjacent individual electrodes may be at least 1 mm. These individual electrodes are recessed relative to the outer surface 1420 of the shaft 1426 of the electronics cartridge 1406. In one configuration example, the individual electrodes are ring electrodes.

[0101] Continuing to refer to Figure 14D, the distance d between the bottom of the head 1422 of the electronics cartridge 1406 and the top of the array of electrodes 1414 is such that, when the electronics cartridge is fully inserted into the lumen 1404 of the sheath screw 1402, each individual electrode belonging to the array of electrodes 1414 aligns with each hole belonging to the array of holes 1408. Due to the recessed position of the individual electrodes of the electronics cartridge 1406 relative to the shaft 1426 when the electronics cartridge 1406 is inserted into the sheath screw 1402, a donut-shaped space is formed between the outer surface of each electrode and the inner wall of the sheath screw 1402. The electrode-tissue interface between the electrode surface and the tissue is realized by the tissue entering the donut-shaped space around the electrodes belonging to the array of electrodes 1414 through the holes in the sheath screw 1402.

[0102] The sheath-shaped screw 1402 and the electronics cartridge 1406 are preferably similar to the mechanisms described above with reference to Figures 2A to 5B and have one or more mechanisms for fixing the cartridge within the screw. Furthermore, one or more electrodes belonging to the array of electrodes 1414 are preferably configured to expand radially and extend at least partially, and possibly entirely, into one of the holes belonging to the array of holes 1408. For this purpose, the electrodes are preferably made of a shape-memory material, such as platinum or a platinum-iridium alloy, so that when the electronics cartridge 1406 is placed in an orthopedically defined location, temperature changes cause the electrodes to change from their set form to another shape-setting form that extends the electrodes into the hole. The expansion change of the electrodes is preferably 0.001 inches (0.025 mm) or more in the axial, radial, or both directions, thereby extending the electrodes into and through the hole, thereby fixing the electronics cartridge 1406 within the sheath-shaped screw 1402 and improving the contact between the electrode surface and the bone tissue interface.

[0103] Referring to Figures 14A to 14D, when implanting the medical device 1400 for the treatment of the fracture site 1442, the sheath screw 1402 is preferably implanted across the fracture site such that the fracture site is located between the opposite ends of the array of holes 1408, preferably in the middle of such ends. Therefore, when the electronics cartridge 1406 is inserted into the sheath screw 1402, one or more of the electrodes are located on opposite sides of the fracture site 1442.

[0104] At least two selected electrodes from the array of electrodes 1414 can be combined with other electronics of the medical device 1400 to form a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. As will be further described below, in this configuration, the medical device 1400 enables the collection of data via selected electrodes placed on opposite sides of the fracture 1442 for the purpose of characterizing the fracture and analyzing its healing. Two selected electrodes from the array of electrodes 1414 can be combined with other electronics of the medical device 1400 to form a tissue conduction communication interface. Further details of the tissue conduction communication interface will be described below.

[0105] Referring to Figures 15A to 15D, in some embodiments, the cartridge configuration of the smart medical device 1500 includes a sheath screw 1502 and an electronics cartridge 1506 configured to be insertable into the sheath screw. In some configurations, the various electronics of the electronics cartridge 1506 are located within the cartridge head 1522, and the power source 1554 is located within a portion of the shaft 1526 of the electronics cartridge, below the head. This structure and characteristics of the sheath screw 1502 and the electronics cartridge 1506, as well as other structures and characteristics, are substantially identical to those described above for the sheath screw 102 and the electronics cartridge 106 in the embodiments of Figures 1A to 1C. Therefore, such details will not be repeated here. Instead, further description of the smart medical device 1500 in Figures 15A to 15D will focus on its distinct features.

[0106] Referring to Figure 15C, the sheath screw 1502 has a pair of holes 1508, 1509 that penetrate its side wall 1510. The pair of holes 1508, 1509 are located within a region of the shaft 1518 of the sheath screw 1502, proximal to the threaded region 1512 of the sheath screw 1502. In some embodiments, an insulating coating is applied to the outer surface 1516 of the sheath screw 1502 within a region of the pair of holes 1508, 1509. In some embodiments, the insulating coating is applied to the outer surface 1516 of the sheath screw 1502 along its entire length, excluding the threaded region 1512.

[0107] Referring to Figure 15D, the electronics cartridge 1506 has a pair of electrodes 1528, 1530. The electrodes 1528, 1530 are separated from each other by a seal 1524 that seals and electrically insulates the individual electrodes from each other. In some embodiments, this seal 1524 corresponds to a region of the hollow shell of the electronics cartridge 1506, which is formed of an insulating material as described above. In other embodiments, the seal 1524 may be a ring made of a non-conductive metal or polymer material or a biocompatible elastomer positioned around the shell of the electronics cartridge 1506. The distance between the electrodes 1528, 1530 may be at least 1 mm. The electrodes 1528, 1530 are recessed relative to the outer surface 1520 of the shaft 1526 of the electronics cartridge 1506. In one configuration example, the individual electrodes 1528, 1530 are ring electrodes.

[0108] Continuing to refer to Figure 15D, the distance d between the bottom of the head 1522 of the electronics cartridge 1506 and the proximal electrode 1528 is such that, when the electronics cartridge is fully inserted into the lumen 1504 of the sheath screw 1502, each electrode 1528, 1530 aligns with the corresponding holes 1508, 1509. Due to the retraction structure of the individual electrodes 1528, 1530 relative to the shaft 1526 of the electronics cartridge 1506, a donut-shaped space is formed between the outer surface of each electrode and the inner wall of the sheath screw 1502 when the electronics cartridge 1506 is inserted into the sheath screw 1502. The electrode-tissue interface between the electrode surface and the tissue is realized by the tissue entering the donut-shaped space around the electrodes 1528, 1530 through the holes 1508, 1509 of the sheath screw 1502.

[0109] The sheath-shaped screw 1502 and the electronics cartridge 1506 are similar to the mechanisms described above with reference to Figures 2A to 5B and preferably have one or more mechanisms for fixing the cartridge within the screw. Furthermore, one or more of the electrodes 1528 and 1530 are preferably configured to expand radially and extend at least partially, and possibly entirely, into one of the holes 1508 and 1509, as described with reference to Figure 14D.

[0110] Referring to Figures 15A to 15D, when implanting the medical device 1500 for the treatment of the fracture site 1542, the tubular screw 1502 is preferably implanted across the fracture site such that the fracture site is located between a pair of holes 1508 and 1509, preferably midway between such holes. Therefore, when the electronic cartridge 1506 is inserted into the tubular screw 1502, the electrodes 1528 and 1530 are located on opposite sides of the fracture site 1542.

[0111] Electrodes 1528 and 1530, in combination with other electronics of the medical device 1500, can constitute a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. As will be further described below, in this configuration, the medical device 1500 enables the collection of data via these electrodes for the purpose of fracture characterization and healing analysis. Electrodes 1528 and 1530, in combination with other electronics of the medical device 1500, can constitute a tissue conduction communication interface. Further details of the tissue conduction communication interface will be described below.

[0112] Referring to Figures 16A to 16D, in some embodiments, the cartridge configuration of the smart medical device 1600 includes a sheath screw 1602 and an electronics cartridge 1606 configured to be insertable into the sheath screw. In some configurations, the various electronics of the electronics cartridge 1606 are located within a head 1622, and a power source 1654 is located within a portion of the shaft 1626 of the electronics cartridge, below the head. This structure and characteristics of the sheath screw 1602 and the electronics cartridge 1606, as well as other structures and characteristics, are substantially identical to those described above for the sheath screw 102 and the electronics cartridge 106 in the embodiments of Figures 1A to 1C. Therefore, such details will not be repeated here. Instead, further description of the smart medical device 1600 in Figures 16A to 16D will focus on its distinct features.

[0113] Referring to Figure 16D, the electronics cartridge 1606 has a cap electrode 1628 associated with the cartridge head 1622 and a tip electrode 1630 located at the distal end of the cartridge. The distance d between the bottom of the head 1622 of the electronics cartridge 1606 and the top of the tip electrode 1630 is such that when the electronics cartridge is fully inserted into the lumen 1604 of the sheath screw 1602 (shown in Figure 16B), the tip electrode 1630 is adjacent to or exposed at the distal end 1605 of the lumen 1604 of the sheath screw 1602, and the cap electrode 1628 is exposed at the head 1619 of the screw. In this embodiment, the exposure of the cap electrode 1628 and the tip electrode 1630 is achieved without requiring sidewall slots or holes, for example, as provided in the embodiments in Figures 13A to 15D.

[0114] Continuing to refer to Figure 16D, in some embodiments, the cap electrode 1628 has a first portion 1632 located in a plane parallel to the top surface of the head 1622, a second portion 1634 that curves downward from the end of the first portion and extends in a plane different from the plane of the first portion and away from the side of the head, and a third portion 1636 that curves upward from the end of the second portion and extends in a plane substantially parallel to the plane of the first portion 1632 and further away from the side of the head.

[0115] Referring to Figure 16A, the exposure of the cap electrode 1628 at the head 1619 of the sheath screw 1602 allows an electrode-tissue interface 1640 to be formed between the third portion 1636 of the cap electrode 1628 and the surface of the bone tissue 1644 when the electronics cartridge 1606 is inserted into the sheath screw 1602. In this embodiment, since a portion of the cap electrode 1628, for example, a first portion 1632 and possibly a second portion 1634, contacts the head 1619 of the sheath screw 1602, it is preferable that the head of the sheath screw 1602 be covered with an insulating material, or that the entire sheath screw 1602 be covered with an insulating material.

[0116] In other embodiments (not shown), instead of providing a cap electrode 1628 exposed on the head 1622 of the electronics cartridge 1606, the cartridge may have an upper electrode located inside the cartridge (either at the head 1622 or in the upper region of the shaft 1626) that is exposed at the side of the cartridge to electrically contact the conductive portion of the sheath-shaped screw 1602. In this embodiment, the entire screw is covered with an insulating material, except for the portion that contacts the upper electrode.

[0117] Referring back to Figure 16D, the tip electrode 1630 is retracted relative to the outer surface 1620 of the shaft 1626 of the electronics cartridge 1606. In one configuration, the tip electrode 1630 is a ring electrode. Due to the retraction of the tip electrode 1630 relative to the shaft 1626 of the electronics cartridge 1606, a donut-shaped space is formed between the outer surface of the tip electrode 1630 and the inner wall of the sheath screw 1602 when the electronics cartridge 1606 is inserted into the sheath screw 1602. The electrode-tissue interface between the tip electrode 1630 and the tissue is realized by the tissue entering the donut-shaped space around the tip electrode 1630 through the distal end 1605 of the sheath screw 1602. A seal 1652 positioned around the shaft 1626 and proximal to the tip electrode 1630 is located on the proximal side of the seal, preventing the intrusion of tissue and bodily fluids into the portion of the medical device 1600, particularly the cap electrode 1628. The seal 1652 is preferably formed from a biocompatible elastomer or polymer material having a durometer of 20A or more, or from a polymer fiber doped material or polymer encapsulation material that can swell when exposed to a solution, or from a non-conductive metal material.

[0118] The sheath screw 1602 and the electronics cartridge 1606 are preferably similar to the mechanisms described above with reference to Figures 2A to 5B and have one or more mechanisms for fixing the cartridge within the screw. Furthermore, the tip electrode 1630 is preferably configured to expand radially and axially, as described with reference to Figure 14D, extending at least partially, and possibly entirely, into the distal end 1605 of the sheath screw. Such expansion helps to fix the electronics cartridge 1606 within the sheath screw 1602.

[0119] Referring to Figures 16A to 16D, when implanting the medical device 1600 for treating the fracture site 1642, the sheath screw 1602 is preferably implanted across the fracture site such that the fracture site is located between the screw head 1619 and the distal end 1621, preferably midway between the head and the distal end. Therefore, when the electronics cartridge 1606 is inserted into the sheath screw 1602, the electrodes 1628 and 1630 are located on opposite sides of the fracture site 1642.

[0120] The electrodes 1628 and 1630, in combination with other electronics of the medical device 1600, can constitute a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. As will be further described below, in this configuration, the medical device 1600 enables the collection of data via these electrodes for the purpose of fracture characterization and healing analysis. The electrodes 1628 and 1630, in combination with other electronics of the medical device 1600, can constitute a tissue conduction communication interface. Further details of the tissue conduction communication interface will be described below.

[0121] Referring to Figures 17A to 17C, in some embodiments, the cartridge configuration of the smart medical device 1700 has a sheath screw 1702 and an electronics cartridge 1706 configured to be insertable into the sheath screw, with a portion of the electronics cartridge penetrating and extending beyond the distal end of the sheath screw. In some configurations, the various electronics of the electronics cartridge 1706 are located within the head 1722 of the electronics cartridge, and a power source 1754 is located within the first portion 1725 of the shaft 1726 of the electronics cartridge, which is located below the head. This structure and characteristics of the sheath screw 1702 and the electronics cartridge 1706, as well as other structures and characteristics, are substantially identical to those described above for the sheath screw 102 and the electronics cartridge 106 in the embodiments of Figures 1A to 1C. Therefore, such details will not be repeated here. Instead, further description of the smart medical device 1700 in Figures 17A to 17C will focus on its distinct features.

[0122] Referring to Figure 17C, the electronics cartridge 1706 has a rigid proximal portion 1760, a rigid intermediate portion 1761, and a non-yielding, flexible distal portion 1762. The proximal portion 1760 includes the head 1722 and first portion 1725 of the shaft 1726 on which the power supply source 1754 is located. In some embodiments, the different portions 1760, 1761, and 1762 of the electronics cartridge 1706 are made of homogeneous implanted grade materials with approximately the same or gradually varying hardness. For example, the proximal portion 1760 is preferably made of a metallic material with a hardness of RA25 or a polymer with a jurometer hardness of 95A or higher. The intermediate portion 1761 is preferably made of the same material, and its hardness is approximately the same as that of the proximal portion 1760. The flexible distal portion 1762 is preferably made of the same material as the proximal portion 1760 and the intermediate portion 1761, but with a hardness less than those regions to allow for flexure in the distal region. In some embodiments, the distinct portions 1760, 1761, and 1762 of the electronics cartridge 1706 are made of different implanted grade materials with nearly the same or gradually varying hardness. In some embodiments, the flexible distal portion 1762 is formed of a matrix polymer.

[0123] The proximal portion 1760, the intermediate portion 1761, and the flexible distal portion 1762 are joined to each other to form a continuous shaft 1726. For this purpose, the first portion 1725 of the shaft 1726, the intermediate portion 1761 of the shaft, and the flexible distal portion 1762 of the shaft are joined to each other by a Morse taper joint, a single-lock threaded mechanism, or a keyway and single-lock thread that creates interconnected sections with a specific axial load capacity, and these maintain a flexible deflection of 1° or more from the central axis. The flexible distal portion 1762 of the shaft has a pair of electrodes 1728, 1730. The distance between the electrodes is at least 1 mm. The electrodes 1728, 1730 are substantially flush with the outer surface of the shaft 1726 of the electronics cartridge 1706. In one configuration example, the electrodes 1728, 1730 are ring electrodes.

[0124] Referring to Figure 17B, in this embodiment, the sheath screw 1702 has a length substantially shorter than the length of the electronics cartridge 1706 and functions to secure the electronics cartridge in place. In some embodiments, the sheath screw 1702 has a shaft 1718 that is substantially equal in length to the length of the first portion 1725 of the shaft 1726 of the electronics cartridge 1706, so that when the cartridge is inserted into the screw, the middle portion 1761 and the flexible distal portion 1762 of the shaft 1726 pass through the end of the screw. In some embodiments, an insulating coating is applied to the outer surface 1716 of the sheath screw 1702. In some embodiments, the sheath screw 1702 is not coated with an insulating coating over its entire length.

[0125] Referring to Figures 17A to 17C, when implanting the medical device 1700 for treating the fracture site 1742, a portal hole sized to receive the electronics cartridge 1706 is formed across the fracture site. The depth of the portal hole is such that the fracture site 1742 is positioned between electrodes 1728, 1730, preferably midway between electrodes, when the electronics cartridge 1706 is later inserted into and through the sheath screw 1702. During implantation, the sheath screw 1702 is implanted into the portal hole, and then the electronics cartridge 1706 is inserted into and partially through the screw. For this purpose, the electronics cartridge 1706 is preferably equipped with a closed lumen for receiving the stylet, the stylet pushing its intermediate portion 1761 and flexible distal portion 1762 beyond the sheath screw 1702 and further into the portal hole. When the electronics cartridge 1706 is inserted into and through the sheath-shaped screw 1702, the electrodes 1728 and 1730 are positioned opposite each other on the fracture site 1742.

[0126] The sheath-shaped screw 1702 and the electronics cartridge 1706 are similar to those described above with reference to Figures 2A to 5B and preferably have one or more mechanisms for fixing the cartridge within the screw. Furthermore, a region 1720 of the flexible distal portion 1762 of the electronics cartridge 1706 is preferably configured to swell or expand upon exposure to a fluid. For this purpose, the flexible distal portion 1762 is preferably made of a matrix polymer that swells upon exposure to sterile water or physiological saline after implantation. The radial and / or axial expansion of region 1720 of the flexible distal portion 1762 helps to fix the electronics cartridge 1706 in place and to create close contact between the electrodes 1728, 1730 and the bone tissue interface.

[0127] The electrodes 1728 and 1730, in combination with other electronics of the medical device 1700, can constitute a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor that functions as an EIS sensor for detecting the location of a fracture and monitoring the healing status of such fracture. As will be further described below, in this configuration, the medical device 1700 enables the collection of data via these electrodes for the purpose of fracture characterization and healing analysis. The electrodes 1728 and 1730, in combination with other electronics of the medical device 1700, can constitute a tissue conduction communication interface. Further details of the tissue conduction communication interface will be described below.

[0128] Installation method for example cartridge configurations A method for implanting a medical device, such as the medical device shown in Figures 1A and 1B, includes the steps of implanting a structure 102 at least partially into the body, and, after implantation of the structure, inserting an electronics cartridge 106 into a lumen 104. This method further includes the step of fixing the electronics cartridge 106 to the structure 102. After fixing the electronics cartridge 106 to the structure 102, it is preferable to remove the cartridge from the lumen 104 without affecting the integrity of the structure or the cartridge. When implanting the structure 102 into the body, it is preferable to insert a support element into the lumen 104 to provide physical support along the length of the shaft of the structure 102. After fixing the structure 102 into the body, the support element is removed, and then the cartridge is inserted into the lumen 104.

[0129] Referring to Figures 18A to 18G, further details are provided of a method for implanting medical devices, such as those shown in Figures 1A and 1B, into a fractured bone. This method involves a two-step insertion process, during which one or more tubular screws are implanted into the bone tissue and an electronics cartridge is inserted into at least one of the tubular screws.

[0130] Referring to Figure 18A, the first guidewire 1802 is driven across the fracture site 1804 of bone 1806 to within a distance of, for example, 5 mm from the lateral region of the bone containing the bone marrow, i.e., the subchondral bone which is the outer surface of the bone. The first guidewire 1802 has an outer diameter smaller than the inner diameter of the sheath screw to be implanted. Referring to Figure 18B, a parallel drill guide 1808 is engaged with the first guidewire 1802 for the purpose of creating a parallel guidewire path or portal hole. Referring to Figures 18C and 18D, three portal holes are drilled in the bone 1806 using the parallel drill guide 1808. The second guidewire 1810 and the third guidewire 1812 are inserted into the portal holes, and the drill guide is removed.

[0131] Referring to Figure 18E, it is preferable to measure the length of the sheath screws 1814 to be inserted into each gate-shaped hole using a depth gauge (not shown). If the head 1818 of the sheath screws 1814 is countersunk, place the head in the measuring instrument. Fit each of the sheath screws 1814 onto its respective guide wire 1802, 1810, 1812 and slide it along the guide wire until the tip of the screw contacts the opening end of its corresponding gate-shaped hole.

[0132] Referring to Figure 18F, the sheathed screw 1814 is screwed into each of the gate-shaped holes using the insertion tool 1822. The tool has a drill bit 1824 configured to engage with the head 1818 of the sheathed screw 1814, and the tool has a lumen 1826 (shown in Figure 18G) that is dimensioned to receive and slide along the guide wires 1802, 1810, 1812.

[0133] Referring to Figure 18G, in some embodiments, the drill bit 1824 may have a hexagonal cross-section, which is sized to fit into a corresponding hexagonal socket on the head 1818. In this embodiment, the drill bit 1824 is fitted onto the guide wires 1802, 1810, and 1812 and slid toward the head 1818 of the sheath screw 1814 to engage with the head. Next, the drill bit 1824 is rotated to pass the sheath screw 1814 through the gate-shaped hole and advance across the fracture portion 1804. The drill bit 1824 is then disengaged from the head 1818 of the sheath screw 1814, and then the guide wires 1802, 1810, and 1812 are removed, leaving the sheath screw in place.

[0134] Referring to Figure 18H, in some embodiments, the drill bit 1824 may have a hexagonal cross-section, which is dimensioned to fit into a corresponding hexagonal socket of the head 1818, and a support shaft 1828 extends from the drill bit, which is configured to fit into the lumen of the sheath screw 1814. The support shaft 1828 may have a feature 1830, for example, a linear projection located along all or part of the shaft, which is configured to fit into a corresponding feature, for example, a straight line or groove, along at least part of the inner side wall of the shaft 1834 of the sheath screw 1814. Each of the drill bit 1824 and the support shaft 1828 further has a lumen 1832 dimensioned to receive and slide along guide wires 1802, 1810, 1812.

[0135] In this embodiment, the support shaft 1828 and the drill bit 1824 are fitted onto the guide wires 1802, 1810, and 1812, and slid toward the head 1818 of the sheath screw 1814. The support shaft 1828 is positioned relative to the sheath screw 1814 so that the projection 1830 of the support shaft aligns with the slot in the shaft 1834 of the sheath screw. The support shaft 1828 is slid toward the lumen of the sheath screw 1814 until the drill bit 1824 engages with the head 1818 of the screw. The drill bit 1824 is rotated together with the support shaft 1828 to pass the sheath screw 1814 through the hole and advance across the fracture 1804. The drill bit 1824 and support shaft 1828 are removed from the sheath screw 1814, and then the guide wires 1802, 1810, and 1812 are removed, leaving the sheath screw in place. The support shaft 1828 provides support along the length of the shaft 1834 of the sheath screw 1814 during insertion, and this support shaft functions to distribute the torque applied during rotation to both the screw head 1818 area and the screw shaft 1834. By distributing the torque in this way, the risk of the sheath screw 1814 breaking during implantation is reduced.

[0136] In one variant configuration, the support shaft 1828 is preferably smooth along its length and does not have features such as, for example, a linear projection or a key. In this configuration, it supports the shaft 1834 of the sheath screw during planting but does not function to transmit torque. In another variant configuration, the support shaft 1828 is preferably a separate component inserted into the lumen of the sheath screw 1814 before engagement of the drill bit 1824. In this configuration, the support shaft 1828 is preferably equipped with features that engage in correspondence with features of the shaft 1834 of the sheath screw 1814, such as grooves or channels, such as a linear projection or a key. In this case, the drill bit 1824 has features configured to engage with the hexagonal end of the support shaft 1828 for the purpose of transmitting torque along the support shaft during the rotation of the drill bit, such as a hexagonal socket.

[0137] Referring to Figure 18I, in some embodiments, the tubular screw 1814 is preferably configured to be placed within a coupling device 1840 as part of the implantation procedure. The coupling device 1840 includes an annular body 1842 having a proximal end region with a proximal opening 1844 sized to receive the tubular screw 1814, and a distal end region with a distal opening 1846 configured to receive and engage with the distal portion 1848 of the tubular screw 1814. This engagement is preferably achieved by thread features provided on the outer circumference of the distal portion 1848 of the tubular screw and thread features provided on the inner circumference of the annular body 1842. Such engagement may also be via a locking mechanism. The coupling device 1840 may further have a cap 1850 configured to engage with the proximal end of the annular body 1842. This fitting is preferably achieved by the thread features of the cap 1850 and the annular body 1842, respectively. The cap 1850 further has a feature 1852, for example, a hexagonal socket, configured to engage with a drill bit. During implantation, the gate-shaped hole provided through the bone is sized to accommodate the annular body 1842 of the coupling device 1840. In Figure 18I, the dimensions of the annular body 1842 relative to the dimensions of the sheath-tubular screw 1814 have not been scaled for illustrative purposes. Generally, the thickness 1854 of the sheath-tubular screw 1814 is smaller than the diameter 1856 of the sheath-tubular screw 1814, and such thickness is preferably, for example, 1 / 4 to 1 / 2 of the diameter of the sheath-tubular screw.

[0138] In this embodiment, the sheath screw 1814 is fixed within the coupling device 1840, for example, the distal portion 1848 of the sheath screw is screwed into the distal opening 1846 of the annular body 1842, and the cap 1850 is coupled to the proximal end of the annular body. The coupling device 1840 and the sheath screw 1814 are fitted onto corresponding guide wires 1802, 1810, and 1812, respectively, and slid along the guide wires until the tip 1858 of the screw abuts against the opening end of its corresponding hole. Referring further to Figure 18G, the drill bit 1824 may have a hexagonal cross-section, which is sized to fit into the corresponding hexagonal socket of the cap 1850 of the coupling device 1840. The drill bit 1824 is fitted onto the guide wires 1802, 1810, and 1812 protruding from the cap 1850 of the coupling device 1840, and then slid toward the cap to engage with it.

[0139] Next, the drill bit 1824 is rotated to pass the coupling device 1840 and the tubular screw 1814 through the portal hole and advance across the fracture site 1804. The drill bit 1824 is rotated in the opposite direction to detach the coupling device 1840 from the tubular screw 1814, and the coupling device is removed from the portal hole, leaving the tubular screw in place. At this stage, the tubular screw 1814 is rotated further, if necessary, by direct engagement with the drill bit, to fully seat the screw. For example, rotating the tubular screw 1814 is good because it brings the screw head into contact with the bone, thereby pressing together with the fractured bone. Next, the guide wires 1802, 1810, and 1812 are removed from the tubular screw 1814. During the rotation of the coupling device 1840, the torque energy applied to the proximal end of the coupling device is transferred along the length of the annular body 1842 to the distal end of the tubular body 1842 and the distal portion 1848 of the sheath-shaped screw, at which point the annular body is coupled to the screw. In this way, torque transmission along the length of the shaft of the sheath-shaped screw 1814 is avoided. By distributing the torque in this manner, the risk of breakage of the sheath-shaped screw 1814 during planting is reduced.

[0140] In an alternative implantation technique, the sheath-shaped screw 1814 can be implanted using the tubular body 1842 without the cap 1850. In this embodiment, the proximal end of the annular body 1842 is configured to engage with the drill bit 1824.

[0141] Referring to Figure 18J, after implanting the sheathed screws 1814, the electronics cartridge 1820 is inserted into at least one of the sheathed screws. In some embodiments, it is preferable to insert the electronics cartridge 1820 into the screw in a two-step process. In the first step, the electronics cartridge 1820 is introduced and positioned inside the sheathed screws 1814 using an insertion tool similar to a syringe. In the second step, the electronics cartridge 1820 is fixed in place inside the sheathed screws 1814 using at least one of the mechanisms described above, referring to Figures 2A to 5B.

[0142] In some embodiments, the electronics cartridge 1820 is preferably inserted into the screw using a guide tool. The guide wire located at the center of the sheath screw 1814 is preferably removed, and then the electronics cartridge 1820 is attached. Before removing the guide wire, the guide tool is fitted onto the guide wire. The tip of the guide tool has a tapered end that contacts the head of the sheath screw 1814. When positioned in this way, the guide tool extends from the surgical site but does not extend beyond the end of the guide wire. With the guide tool in contact with the screw head, the guide wire is removed, and the electronics cartridge 1820 is lowered within the guide tool until it finally slides into the sheath screw 1814.

[0143] Example of a backup load configuration Referring to Figures 19A to 19D, in some embodiments, the preloaded smart medical device 1900 has a structure 1902 including a head 1904 and a shaft 1906, each having a head cavity 1908 and a shaft cavity 1910, respectively. In some embodiments, the medical device 1900 is a screw configured to be implanted in bone tissue. The medical device 1900 further includes an antenna 1944 and an electronics assembly 1912 located in the head cavity 1908 and a power source 1954 located in the shaft cavity 1910. At least one electrode 1914 is associated with the shaft 1906 and is electrically coupled to the electronics assembly 1912 by a conductor 1916 that penetrates the side wall of the shaft 1906. With respect to the antenna 1944, it is preferable that the antenna be a conductive wire 1946 or trace wire extending along an antenna board 1949 inserted in a material 1947, such as PEEK, ceramic, or a material that enables communication and connectivity, such as RF signal transmission or reception. With respect to the power source 1954, the power source is coupled to the electronics assembly 1912 via a pair of battery contacts 1955.

[0144] The preloaded smart medical device may be structurally similar to any one of the cartridge configuration examples described above, but with respect to the electronic cartridge, it is permanently fixed in a structure, such as a sheath screw, during manufacturing. For example, the preloaded smart device may be manufactured by inserting the electronic cartridge into a sheath screw, welding the head of the electronic cartridge into the head of the sheath screw or fixing the head in place with a biocompatible adhesive, such as a silicone or urethane-based adhesive, and then hermetically sealing the assembly at the distal and proximal ends, respectively. In these preloaded configuration examples, either the head of the electronic cartridge or the head of the sheath screw is configured to receive an implantation tool. For example, the electronic cartridge may have a socket head that engages with the implantation tool, or the head of the sheath screw may have features on its outer surface that engage with the implantation tool, as shown in Figure 4, for example.

[0145] The structural features of the auxiliary load configuration example are almost the same as those described for the cartridge configuration example. Therefore, these features will not be repeated here.

[0146] Referring to Figures 20A and 20B, in some embodiments, the pre-loaded smart medical device 2000 has a sheath-like structure 2002 configured to be at least partially implanted in the body. The sheath-like structure 2002 has a lumen 2004 extending through it, a plurality of holes 2006, 2008 provided through the side wall 2010, and a plurality of electrodes 2012, 2014, each associated with each of the plurality of holes. The medical device 2000 further has an electronics cartridge 2016 located at least partially within the lumen 2004 of the sheath-like structure 2002. The electronics cartridge 2016 has electronics, such as an antenna, ASIC, power source, etc. The electronics cartridge 2016 further has several electrical contacts 2018, 2020, each electrical contact associated with each of the holes 2006, 2008 to realize an electrical coupling between the cartridge's electronics and each of the electrodes 2012, 2014.

[0147] The sheath-like structure 2002 has a substrate 2024 having an outer surface 2026 and an inner surface 2028. A first electrode 2012 of a plurality of electrodes is positioned on the outer surface 2026 of the substrate, and this first electrode has a feedthrough 2030 that extends through a first hole 2006 of a plurality of holes to the inner surface 2028 of the substrate. A second electrode 2014 of a plurality of electrodes is also positioned on the outer surface 2026 of the substrate, and this second electrode has a feedthrough 2032 that extends through a second hole 2008 of a plurality of holes to the inner surface 2028 of the substrate.

[0148] In some embodiments, the substrate 2024 is formed of an insulating material. In some embodiments, the substrate 2024 is made of a conductive material coated with an insulating material 2034. As shown in Figure 20B, the substrate 2024 is preferably treated or coated such that the outer surface 2026, inner surface 2028 and the inner walls 2036, 2038 of each pore 2006, 2008 are electrically insulated. For example, the titanium substrate 2024 is preferably anodized to make its surface insulating.

[0149] Electrodes 2012 and 2014 are preferably formed by coating or treating the outer surface 2026 of the substrate 2024 to create the outer portion of the electrode. The inner walls 2036 and 2038 of the holes 2006 and 2008 and adjacent portions of the inner surface 2028 of the substrate 2024 are similarly coated or treated. The coating or treatment is preferably carried out by electroplating or silk screening, for example. After forming electrodes 2012 and 2014 by electroplating, for example, it is preferable to fill the holes 2040 and 2042 that penetrate the electrodes with a material to reinforce the side walls 2010 of the sheath-like structure 2002, or to create electrodes without holes in order to reinforce the side walls by controlling the electrode plating process.

[0150] Electrodes 2012 and 2014 may be custom-plated shapes as shown in Figure 20B, or they may be the shaped ends of conductive pins provided through the sidewalls 2010 of the sheath-like structure 2002. These fabrication techniques allow any number, any size, and any shape of electrodes to be added to the surface of the screw. Electrodes 2012 and 2014 are separated from each other by an insulating seal 2046. The insulating seal 2046 prevents harmful electrical contact between the electrodes, even if the space between them is filled with conductive fluid. The insulating seal 2046 may be an O-ring or a responsive overmolded silicone wiper.

[0151] Continuing to refer to Figures 20A and 20B, in one configuration example, the electronics cartridge 2016 has a connecting leg 2048 extending downward along the lumen 2004 of the sheath-like structure 2002. The connecting leg 2048 has a conductive central peg 2050 with a distal end forming a first electrical contact 2018, an insulating core 2052, and a conductive jacket surrounding a portion of the insulating core to form a second electrical contact 2020. Thus, the electronics cartridge 2016 has a first electrical contact 2018 positioned to contact the feedthrough 2030 of the first electrode 2012 on the inner surface 2028 of the substrate, thereby realizing an electrical coupling between the electronics and the first electrode, and a second electrical contact 2020 positioned to contact the feedthrough 2032 of the second electrode 2014 on the inner surface of the substrate, thereby realizing an electrical coupling between the electronics and the second electrode.

[0152] Referring to Figures 21A and 21B, in some embodiments, the pre-loaded smart medical device 2100 has a sheath-like structure 2102 configured to be at least partially implanted in the body. The sheath-like structure 2102 has a lumen 2104 through which it passes, a plurality of holes 2106a to 2106d through the side walls 2110, and a plurality of pin electrodes 2112a to 2112d, each associated with each of the plurality of holes. The medical device 2100 further has an electronics cartridge 2116 located at least partially within the lumen 2104 of the sheath-like structure 2102. The electronics cartridge 2116 includes electronics, such as an antenna, ASIC, power source, etc. The electronics cartridge 2116 further has a plurality of electrical trace lines 2114a to 2114d, each having distal ends 2116a to 2116d, the distal ends 2116a to 2116d align with corresponding holes 2106a to 2106d, thereby realizing an electrical coupling between the cartridge electronics and pin electrodes 2112a to 2112d.

[0153] The sheath-shaped structure 2102 has a substrate 2124 having an outer surface 2126 and an inner surface 2128. In some embodiments, the substrate 2124 is formed of an insulating material. In some embodiments, the substrate 2124 is formed of a conductive material coated with an insulating material 2134. As shown in Figure 21B, the substrate 2124 is preferably treated or coated so that the outer surface 2126, the inner surface 2128, and the inner walls of each of the holes 2106a to 2106d are insulated. For example, the titanium substrate 2124 is preferably anodized so that these surfaces are electrically insulated.

[0154] The pin electrodes 2112a to 2112d are preferably bonded or pressure-fitted into the holes 2106a to 2106d to contact the corresponding distal ends of the distal ends 2116a to 2116d. The pin electrodes 2112a to 2112d may be rigid or spring-operated pogo-type pins biased to extend radially outward from the holes 2106a to 2106d. In configurations where the substrate 2124 of the sheath-tubular structure 2102 is conductive but not covered with insulating material, the pin electrodes 2112a to 2112d have an insulating outer surface and a conductive core. The pin electrodes 2112a to 2112d may also be bonded into the holes 2106a to 2106d using an insulating binder. The pin electrodes 2112a to 2112d may be riveted into the holes 2106a to 2106d, and the ends of the pins may be flattened and made into electrodes in the riveting process. The pin electrodes 2112a to 2112d may also be formed together by filling the holes 2106a to 2106d with a conductive material (e.g., conductive epoxy) that solidifies. This can help increase the strength of the side walls 2110 of the sheath-like structure 2102 near the holes 2106a to 2106d.

[0155] Electrical elements and features Having thus disclosed examples of cartridge configurations and pre-integrated configurations of smart medical devices, as well as the mechanical, material, and other structural details of these various embodiments, we will now describe the electrical and operational elements and features of two configuration examples.

[0156] Referring to Figure 22A, an example of a smart medical device configuration includes an implantable reporting processor (IRP) 2203. The IRP 2203 includes a power source 2212, a sensing electrode 2221, an electronics assembly 2210, an antenna 2230, communication electrodes 2231, 2233, and an acoustic transducer 2236.

[0157] The circuitry of the electronics assembly 2210 may include one or more sensors 2222, electrode switches 2223, and detection circuits / modules 2227. In some embodiments, as further disclosed below, the detection electrode 2221, electrode switch 2223, and detection circuit / module 2227 function together as a sensor 2229 configured to monitor the electrical properties of the tissue. For example, the sensor 2229 may be an impedance sensor.

[0158] The circuitry of the electronics assembly 2210 may include a fuse 2214, one or more power switches 2216, 2218, a clock oscillator, a power management unit 2220, a memory 2224, a controller 2232, and a communication circuitry 2225. The communication circuitry 2225 may include one or more of the following: a radio frequency (RF) transceiver 2226 coupled with an antenna 2230 and a filter 2228, a tissue conduction communication (TCC) circuitry 2238 coupled with a set of communication electrodes 2231, 2233, or a data-over-sound circuitry 2240 coupled with an acoustic transducer 2236. Examples of some or all of these components are described elsewhere in this application or in U.S. Patent Application No. 16 / 084,544, which are referred to by reference in all jurisdictions relating thereto and which are incorporated herein by reference. In one embodiment, the electronics assembly 2210 is preferably an ASIC chip with the possibility of refilling via a 2mF to 8mF capacitor for processing and transmitting data packages.

[0159] As stated above, IRP2203 includes one or more sensors 2222,2229. "Sensor" means a combination of components that form a device or sensor that can be used to perform one or more of the following: 1) detecting, measuring and / or monitoring one or more aspects of the state or function of the body or body segment / joint (including fracture healing, movement including measurement of position, angle, velocity, and acceleration of body segments and joints); 2) detecting, measuring and / or monitoring one or more different aspects of body tissue (anatomical structure, physiology, metabolism, and / or function); and / or 3) detecting, measuring and / or monitoring one or more aspects of orthopedic instruments or implants.

[0160] Referring to Figure 22B, as described above, in some embodiments, the IRP2203 includes an impedance sensor 2229 having a detection electrode 2221, an electrode switch 2223, and a detection circuit / module 2227. The detection electrode 2221 may include a number of individual electrodes 2231a to 2231n. In some embodiments, the number of electrodes 2231a to 2231n may be at least two, and up to eight or possibly more. Referring to Figures 1A to 1C, in some embodiments, the detection electrode 2221 may correspond to electrodes 128 and 130 associated with the sheath screw 102. Referring to Figures 13A to 13D, in some embodiments, the detection electrode 2221 may correspond to electrodes 1328 and 1330 associated with the electronics cartridge 1306. Referring to Figures 14A to 14D, in some embodiments, the detection electrode 2221 preferably corresponds to an array of electrodes 1414 associated with the electronics cartridge 1406.

[0161] Referring back to Figure 22B, in some embodiments, the detection circuit / module 2227 for the impedance sensor 2229 includes a switch controller 2234, a signal generator 2235, an impedance calculator 2237, a digital-to-analog converter (DAC) 2239, a digital transconductance amplifier (GMC) 2241, and an analog-to-digital converter (ADC) 2243. In this configuration example, the impedance sensor 2229 functions as an EIS sensor that measures frequency-dependent impedance through anatomical structures for the purpose of characterizing fracture sites and determining the healing status or pathological condition of fracture sites. In this context, the EIS sensor is described, for example, in Monica C. Lin et al., "New Opportunities for Fracture Healing Detection: Impedance Spectroscopy Measurements Correlate to Tissue Composition in Fractures," Journal of Orthopaedic Research, published December 2017. This non-patent document is cited by reference and its contents are incorporated into this specification.

[0162] Continuing to refer to Figure 22B, the medical device may have a sensor system 2229, such as an impedance sensor or EIS sensor, which includes one or more detection electrodes 2231a-2231n and one or more components 2223,2227 electrically coupled to one or more detection electrodes to monitor the electrical properties of the tissue for the purpose of characterizing the healing of a fracture site. Two structural embodiments of such a medical device are envisioned: one embodiment in which the sensor components of the sensor system 2229 are contained within a single medical device, and another embodiment in which the sensor components are arranged across a wide variety of structures of the medical device.

[0163] Referring to Figures 24A and 24B, the first embodiment relates to a single medical device 2400 having a structure configured such that a plurality of detection electrodes 2420 are implanted in the bone 2410 to bridge the fracture site 2408. In this embodiment, the length of the medical device 2400 is selected to allow for the positioning of a first detection electrode 2428 on a first side of the fracture site 2408, and the positioning of a second detection electrode 2430 on a second side of the fracture site opposite to the first side.

[0164] Referring to Figure 24C, in the second embodiment, the first detection electrode 2428 of the medical device 2400 is associated with a first implant or structure 2402 configured to be implanted on the first side of the fracture 2408, and the second detection electrode 2430 of the medical device is associated with a second implant or structure 2404 configured to be implanted on the second side of the fracture. In this embodiment, the medical device 2400 has a third implant or plate 2406 configured to straddle the structures 2402 and 2404. The plate 2406 serves as a means of electrically coupling the two detection electrodes 2428 and 2430 to a common detection component. The common detection component is preferably located in one or more of the first structure 2402, the second structure 2404, and the plate 2406.

[0165] In any embodiment, impedance measurements across the fracture site 2408 can be obtained, and such impedance measurements can be analyzed over time as a means of monitoring the healing process from the inflammatory stage to the repair stage, for example from hematoma to callus, as the fracture site transitions to bony callus / spongiform bone. For this purpose, the change in impedance measurements as a function of time can be obtained by the medical device 2400. If a certain measurement is obtained periodically, for example, once every hour or once every six hours, a dataset of impedance measurements over time can be collected. In some embodiments, the dataset of impedance measurements is analyzed on a substrate by the medical device 2400, thereby obtaining outcomes that depict the healing conditions of the fracture site. In some embodiments, the dataset is transmitted to an external device for analysis to obtain outcomes that depict the healing state of the fracture site.

[0166] In any case, such depiction should preferably include one of the following: "union" (meaning that the fracture site 2408 has healed, for example, the magnitude of the impedance before and after the fracture site has increased above the baseline by a threshold amount, e.g., the percentile), "suspected non-union" (meaning that healing has not progressed to a level corresponding to union, for example, the magnitude of the impedance before and after the fracture site has increased relative to the baseline, but the increase is too small and the rate of increase is too slow as a function of time), or "non-union" (meaning that healing has not occurred, for example, the magnitude of the impedance before and after the fracture site remains the same over time).

[0167] In some embodiments, the outcome of the analysis is obtained based on a comparison between a benchmark derived from a patient dataset of impedance measurements and a benchmark derived from a reference dataset of impedance measurements across the entire patient population. For example, a benchmark of impedance change over a period derived from the patient dataset can be compared to a benchmark of impedance change over the same period derived from a reference dataset to determine whether the patient's measurement falls within the acceptable range of the reference measurement. If it is determined that the patient's measurement is outside the acceptable range, the smart medical device 2400 should issue an alarm. For example, if the patient's measurement is only slightly below the reference measurement threshold, for example, if it is only slightly below the 1st percentile, an alarm should be issued.

[0168] In some embodiments, measurements corresponding to different stages or modalities of bone healing over time are preferably defined based on a baseline dataset. For example, referring to Figure 23, the baseline dataset can define the expected change in impedance at 7 days post-implantation representing the "cartilage" healing state, the expected change in impedance at 13 days post-implantation representing the "C and C" healing state (in which case "C and C" represents cartilage and cancellous bone), the expected change in impedance at 19 days post-implantation representing the "cancellous bone" healing state, and the expected change in impedance at 28 days post-implantation representing the "cortical" healing state. Comparing patient measurements at approximately the same time after implantation with baseline measurements allows for tracking the patient's healing status and issuing alerts if the patient's measurements fall outside the acceptable range of the corresponding baseline measurements.

[0169] Referring to Figure 22B, as described above, the impedance sensor 2229 can function as an EIS sensor for obtaining impedance measurements. For this purpose, in some embodiments, the impedance sensor 2229 employs a two-point impedance detection method, and the detection electrode 2221 includes a first electrode and a second electrode. The first and second electrodes are preferably selected from a plurality of available detection electrodes 2231a to 2231n. The detection circuit / module 2227 is configured so that the first and second electrodes can function in either application mode or detection mode. In application mode, a signal, such as a current, is applied to the first and second electrodes. For example, it is preferable to apply the signal to the first electrode with the second electrode grounded. In detection mode, the impedance between the first and second electrodes is detected based on the potential change between the electrodes.

[0170] Regarding the application mode, in some embodiments, the signal generator 2235 generates a digital display 2245 of a time sine wave at a first frequency and provides this sine wave signal to both the DAC 2239 and the impedance calculator 2237. The DAC 2239 receives the digital display 2245, converts it to an analog sine wave voltage 2247, and provides it to the GMC 2241. The GMC 2241 converts the analog sine wave voltage 2247 to a sine wave current 2249. The GMC 2241 outputs the sine wave current 2249 to the electrode switch 2223, which applies the sine wave current to the first electrodes 2231a-2231n of the sensing electrode 2221. The sine wave current 2249 is applied to the body tissue by a voltage which is the potential difference between the first and second electrodes 2231a-2231n of the sensing electrode 2221 that are installed.

[0171] In detection mode, the voltage 2251 applied to the first and second electrodes and passing through the body tissue is detected by the ADC 2243, which has an input coupled to the first electrode via an electrode switch 2223. The ADC 2243 converts the voltage 2251 into a digital voltage 2253 and provides this voltage to the signal generator 2235. The signal generator converts the digital voltage 2253 into a digital sinusoidal voltage 2255 and provides this to the impedance calculator 2237. The impedance calculator 2237 calculates the impedance based on the digital display 2245 of a time sine wave at a first frequency and generates the resulting digital sinusoidal voltage 2255.

[0172] It is best to repeat the above for different frequencies within the frequency range. Different impedance measurements at different frequencies allow for the collection of different measurements that can display different fracture healing responses. Analysis of measurements at different frequencies shows that the impedance changes to a particular frequency or subset of frequencies correlate best with the healing stage. For each frequency, the impedance calculator 2237 processes the digital display 2245 and digital sinusoidal voltage 2255 of the corresponding sine wave over time to calculate the composite impedance (Z) of the anatomical structure. As described above, these impedances are collected over time to form a dataset, and these are then analyzed to obtain outcomes corresponding to the fracture healing state.

[0173] Referring again to Figure 22B regarding obtaining impedance measurements, in some embodiments the impedance sensor 2229 employs a four-point impedance detection method, and the detection electrodes 2221 include a first electrode, a second electrode, a third electrode, and a fourth electrode, which are switchably coupled to a detection module via an electrode switch 2223. The first and second electrodes are preferably selected from a plurality of available detection electrodes 2231a to 2231n. The detection circuit / module 2227 is configured such that the first and second electrodes can function in application mode, and the third and fourth electrodes can function in detection mode. In application mode, a signal, such as a current, is applied to the first and second electrodes. For example, it is preferable to apply the signal to the first electrode with the second electrode grounded. In detection mode, the impedance between the third and fourth electrodes is detected based on the potential between the third and fourth electrodes.

[0174] In some embodiments, changes in impedance represent the progress of healing. For example, referring to Figure 23, Figure 2300 shows a graph of the magnitude of impedance 2302 measured before and after a fracture as a function of time 2304 using a pair of detection electrodes spaced 27 mm apart, based on EIS measurements at a frequency of 5000 Hz. Different fracture characteristics or the progress of healing, including cartilage and cancellous bone (C and C), cancellous bone, and cortex, are represented by corresponding increases in the magnitude of impedance between day 5 and day 35. In this embodiment, given the increase in the magnitude of impedance over time, the data analysis outcome at day 35 indicates "union" (meaning the fracture has healed).

[0175] The impedance sensor 2229 of the smart medical device 2400 offers several advantages compared to other bone healing monitoring methods. For example, the monitoring function of the medical device 2400 eliminates the need for intermediate X-ray transmission, thereby reducing medical care costs and patient inconvenience of having to go to an imaging facility. In cases of suspected nonunion, the monitoring function of the medical device 2400 identifies delayed healing earlier than imaging monitoring, and anticipates additional patient care and complementary and / or alternative treatment options. In cases of nonunion, the monitoring function of the medical device 2400 identifies non-healing fractures earlier than imaging monitoring, thereby taking into account other options for the patient, such as new surgery, for example, hip replacement. The medical device 2400 also provides an improved clinician workflow by providing relevant remote patient monitoring (RPM) data over a period of time, which can provide useful information relatively automatically and potentially meet the minimum requirements for organization.

[0176] Referring to Figures 22A, 22B, and 24B, when considering embodiments of smart medical devices in which the sensor components of the sensor system 2229 are included in a single medical device, in a particular configuration example, the medical device 2400 may have multiple electrodes 2420 along its shaft. In this configuration example, the switch controller 2243 may be configured to control the electrode switch 2223 and test various electrode pairs to first locate the fracture site 2408, then select the electrode located on the first side 2460 of the fracture site to serve as the first electrode 2428, and then select the electrode located on the second side 2462 of the fracture site to serve as the second electrode 2430, thereby selecting the first electrode 2428 and the second electrode 2430 from among the multiple electrodes 2420.

[0177] To pinpoint the location of a fracture, it is best to obtain impedance measurements between adjacent pairs of electrodes along the shaft of the medical device 2400, which will eventually yield measurements that represent the fracture site. For example, the fracture site 2408 may be determined to be located between the pairs of electrodes with the highest impedance measurements. Regarding the selection of the first electrode 2428 and the second electrode 2430, any electrodes on either side can be selected, but electrodes placed close together tend to yield more accurate impedance measurements. Therefore, generally speaking, the electrodes located closest to the fracture site 2408 but on the opposite side are selected as the first electrode 2428 and the second electrode 2430.

[0178] The initial electrode selection is preferably performed during implantation of the medical device by a physician's interface, such as a programmer, configured to detect the location of the fracture relative to the paired electrodes based on impedance measurements. For this purpose, an external programmer is preferably used to control the implanted switch controller 2234 to perform the electrode selection process described above.

[0179] Continuing with reference to Figures 22A, 22B, and 24B, in another configuration example of a smart medical device in which the sensor components of sensor system 2229 are included in a single medical device, the medical device 2400 may further have a third electrode 2448 and a fourth electrode 2450 located on the outer surface of the structure 2402, and one or more electrical components include a signal generator and an impedance sensor. The first electrode 2428 and the second electrode 2430 are coupled to a signal generator to enable an application mode in which a signal, such as a current, is applied to the first and second electrodes. The third electrode 2448 and the fourth electrode 2450 are coupled to an impedance sensor to enable a detection mode in which the potential between the third electrode and the fourth electrode is measured, and the impedance is calculated based on the current applied to the first and second electrodes.

[0180] Referring to Figures 22A, 22B, and 24C, an embodiment of a smart medical device in which the sensor components of the sensor system are positioned across a wide variety of structures of the medical device is considered. In a particular configuration example, the medical device 2400 has a first structure 2402 configured to be at least partially implanted in bone 2410 and including at least one electrode 2428, a second structure 2404 configured to be at least partially implanted in bone and having at least one second electrode 2430, and a third implant or structure 2406 configured to be positioned on the bone across the fracture site 2408 and fixed in place by the first and second structures. One or more electrical components are associated with one or more of the first structure 2402, the second structure 2404, and the third implant or structure 2406. These electrical components include sensors configured to enable measurement of tissue impedance between the first electrode 2428 and the second electrode 2430.

[0181] Referring to Figure 22A, as described above, in some embodiments, the IRP2203 may include one or more other sensors 2222 in addition to the impedance sensor 2229. Typical examples of other sensors 2222 suitable for use in the IRP2203 include ultrasonic sensors, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), impedance sensors, conductive sensors, optical sensors, acoustic sensors, accelerometers, gyroscopes, mechanical stress sensors, and temperature sensors.

[0182] A wide variety of sensors (also known as microelectromechanical systems or "MEMS," or nanoelectromechanical systems or "NEMS," and BioMEMS or BioNEMS; see https: / / en.wikipedia.org / wiki / MEMS for more information) can be used. Representative patents and patent application publications include U.S. Patent Nos. 7,383,071, 7,450,332, 7,463,997, 7,924,267, and 8,634,928, as well as U.S. Patent Application Publication Nos. 2010 / 0285082 and 2013 / 0215979. Representative publications include Albert Foch, "Introduction to BioMEMS," CRC Press, 2013; Marc J. Madou, "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and applications," CRC Press, 2011; Simona Badilescu, "Bio-MEMS: Science and Engineering Perspectives," CRC Press, 2011; and Steven S. Solitterman. Saliterman), "Fundamentals of BioMEMS and Medical Microdevices," SPIE (The International Society of Optical Engineering), 2006, Wanjun Wang, Steven A. Soper.Soper (eds.), "Bio-MEMS: Technologies and Applications," CRS Press, 2012; Volker Kempe, "Inertial MEMS: Principles and Practice," Cambridge University Press, 2011; Polla, DL et al., "Microdevices in Medicine," Annual Review of Biomedical Engineering, 2000, Vol. 2, pp. 551-576; Yun, KS, et al. Yeh, R., et al., "A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations", 11:5, Journal of Microelectromechanical Systems, October 2002, pp. 454-461; Yeh, R., et al., "Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors", 11:4, Journal of Microelectromechanical Systems, August 2002, pp. 330-336; Loh, NC, et al. al.), "Sub-10cm." 3The document cited is "Sub-10cm3 Interferometric Accelerometer with Nano-g Resolution," 11:3, Journal of Microelectromechanical Systems, June 2002, pp. 182–187. All of the above-mentioned patent and non-patent documents are cited by reference and their entire contents are incorporated herein by reference.

[0183] The sensor 2222 may be located on the printed circuit board of the electronics assembly 2210 or in another structure of the smart medical device, spaced apart from the IRP 2203, but electrically coupled to the electronics assembly. In a particular embodiment, the sensor 2222 may have a processor or be coupled to a processor located on the printed circuit board of the electronics assembly 2210. In other embodiments, the sensor may be a wireless sensor. In another embodiment, one or more (including all) of the sensors may have a unique sensor identification (USI) number that specifically identifies the sensor.

[0184] The sensor 2222 is preferably an ultrasonic sensor used to characterize the degree of fracture healing based on known ultrasonic technology. For this purpose, an ultrasonic sensor of appropriate size and with power requirements that can be supported by the medical device is preferably placed in a structure of the medical device, such as a sheath screw or electronic cartridge, where the sensor is placed at or near the fracture site during implantation of the medical device. Ultrasonic measurements of the tissue at the fracture site can be obtained over time, and processing these can provide one or more of the characteristics of the fracture site and the characteristics of the tissue within a region of the structure.

[0185] The sensor 2222 is preferably a strain sensor used to characterize the degree of fracture healing based on known mechanical stress / strain techniques. For this purpose, the strain sensor is preferably placed in a structure of a medical device, such as a sheathing screw or electronic cartridge, where the sensor is placed at or near the fracture site during implantation of the medical device. Strain measurements at the fracture site can be obtained over time, and processing these can provide one or more of the following: characterization of the fracture site and characterization of the tissue within a region of the structure.

[0186] The sensor 2222 is preferably a glucose detector or oxygen sensor used to characterize tissue inflammation based on known techniques. For this purpose, the glucose detector or oxygen sensor is preferably placed within a structure of a medical device, such as a sheath screen or electronic cartridge, where the sensor is positioned at or near the fracture site during implantation of the medical device. Sensor measurements at the fracture site can be obtained over time, and these can be processed using known techniques to provide indicators of inflammatory fluid, interstitial fluid, or other biological fluids, such as blood, within a region of the medical device.

[0187] Sensor 2222 can be used to detect, measure, and / or monitor information regarding the condition of a medical device after implantation. The condition of the medical device may include information regarding the device's integrity (device fracture), device motion (device backout), forces acting on the device, and other information regarding the implanted medical device. Examples of these types of sensors 2222 include gyroscopes, accelerometers, temperature sensors, and pressure sensors.

[0188] Sensor 2222 can be used to detect, measure, and / or monitor information regarding the state of the body or body segment after implantation of a medical device. This includes kinematic information of the body or body segment. Examples of these types of sensors 2222 include gyroscopes, accelerometers, temperature sensors, and pressure sensors coupled to a processor. In some embodiments, sensor 2222 may include an inertial measurement unit (IMU), such as an accelerometer or gyroscope, configured to output signals corresponding to the movement of the medical device 100, and, depending on the context, the movement of the bone structure in which the device is implanted, and the movement or activity level of the patient in which the device is implanted.

[0189] Sensor 2222 can be used to detect, measure, and / or monitor information about body tissue after implantation of a medical device. Body tissue monitoring may include blood pressure and pH levels. Examples of this type of sensor 2222 include fluid pressure sensors, fluid volume sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), and metabolic sensors (e.g., for blood and / or other fluids). Sensor 2222 can also be used to monitor the temperature within a region of a medical device for the purpose of detecting infection.

[0190] The power source 2212 is configured to power the components of the IRP 2203 by generating a regulated supply signal in the range of approximately 1 volt (V) to 24 volts (V). The power source 2212 may include one or more of the following: a battery, a rechargeable power device (e.g., a rechargeable battery or supercapacitor), and an energy extraction device.

[0191] In some embodiments, the power source 2212 of the IRP2203 may be any suitable battery, such as a lithium-carbon monofluoride (LiCFx) battery, or another rechargeable battery configured to store energy to power the components of the electronics assembly 2210 so that the expected lifespan of the smart medical device (e.g., 5 to 25 years or more) can be obtained.

[0192] The size of the power source 2212 is generally constrained by the size of the medical device structure, such as the sheath screw or the electronics cartridge shell. For example, referring to Figures 13C and 13D, the diameter of the power source 1354 is limited by the diameter of the inner lumen 1304 of the sheath screw 1302. In another embodiment, referring to Figures 17A-17C, the diameter of the power source 1754 is limited by the diameter of the shaft 1726 of the electronics cartridge 1706. In yet another embodiment, referring to Figures 19A and 19B, the diameter of the power source 1954 is limited by the diameter of the lower cavity of the structure 1902. In the exemplary design example, the battery diameter is preferably greater than 1 mm, and generally in the range of 1 mm to 5 mm. The battery length is preferably greater than 1 mm, and generally at least 3 mm. The battery volume is 2 mm 2 It is good to exceed the following. The battery capacity should ideally exceed 1mAh, however, based on measurements and communications, more energy, for example around 100mAh, may be required. The power required to fully charge in one hour should ideally exceed 5mW, and generally speaking, it is good to be in the range of 5mW to 150mW.

[0193] In some embodiments, the power source 2212 of the IRP2203 is preferably a supercapacitor. Supercapacitors are attractive due to their rapid charge / discharge characteristics, for example, a 2.8mAh battery rated at 0.2C charge / discharge and a 5-hour charge time. Supercapacitors also have a higher current supply capability compared to batteries. The supercapacitor is preferably an electrochemical double-layer capacitor (EDLC) supercapacitor or a wire-type supercapacitor. Commercially available EDLCs have only half the volumetric energy density of "novel" wire-type supercapacitors. Therefore, wire-type supercapacitors are preferred.

[0194] The example characteristics and specifications for the wire-type supercapacitor are as follows: form factor (2 × 0.5 mm outer diameter wire), 153.3 Wh / kg -1 Gravimetric energy density (1 / 3 of LiCFx): 8810 Wkg -1 Includes a power density (20 times that of LiCFx). Illustrative characteristics and specifications for the EDLC are: form factor (3.2 × 2.5 × 0.9 mm), single-digit μAh, 2.3 mWhcm. -3 Includes.

[0195] In some embodiments, the power source 2212 of the IRP 2203 is preferably a hybrid solution. In this example configuration, the IRP includes a first power source for measurement, e.g., a primary battery, and a second power source for temporarily buffering energy while exchanging data, e.g., a supercapacitor.

[0196] The power source 2212 of the IRP2203 is preferably a rechargeable power device, such as a lithium-ion battery or a supercapacitor. In this case, the power source 2212 and / or electronics assembly 2210 include additional components for charging the power source by an external recharging unit. These additional components include power coils configured to generate voltage and current in response to a magnetic field generated by the external recharging unit. Possible energy transmission modes include far-field RF, near-field RF, and ultrasound.

[0197] An example configuration for far-field energy transmission has the following operating parameters: power 0.24 / 32mW, frequency 2.34 / 1GHz, efficiency 12 / 0.2%, and antenna size 9 / 2160mm. 2 The range is 20 / 150 cm, and the allowable specific absorption rate (SAR) limit (1.6 W / kg) restricts power transmission. Far-field energy transmission can be directed by multiple antennas. Furthermore, far-field energy transmission is preferably carried out using antennas used for communications. For example, antenna 144b in Figure 9B can be used for both RF energy transmission and RF communications.

[0198] In the example configuration for near-field RF energy transmission, the operating parameters are: power 0.2 / 15.7mW, frequency 10MHz / 1.5GHz, efficiency 15.2 / 0.5%, and antenna size 2.3 / 6mm. 2 The depth is 0.5 / 3 cm. Near-field energy transmission requires precise tuning and alignment as well as close contact with the skin.

[0199] In this example configuration for ultrasonic energy transmission, the operating parameters are: power 0.36mW@1MHz, efficiency up to 5.6%, and transducer size 1×1mm. 2The minimum depth is 5 mm or more, which is related to the maximum thickness in people with a BMI (Body Mass Index) up to 45. In this configuration example, it can be said that energy can be transmitted to a skin depth of more than 10 cm. Ultrasonic energy transmission can lose efficiency when traveling through many tissue types, and such ultrasonic energy transmission requires direct contact with the skin.

[0200] The energy extraction device is configured to convert environmental stimuli into energy for charging a rechargeable power device. For example, the extraction device can convert one or more of the following into battery charging current or voltage or supercapacitor charging: body heat from a subject with an IRP2203 implanted, kinetic energy generated by the subject's movement, pressure changes (e.g., atmospheric pressure or internal pressure in the subject, e.g., the subject's blood pressure), energy generated by electrochemical reactions in the subject's body, radio frequency (RF) fields, light, electromechanical conversion (e.g., piezoelectric), or energy generated by electromagnetic conversion.

[0201] The fuse 2214 may be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent current flowing from the power source 2212 or battery from causing injury to the patient or damaging the battery and one or more components of the electronic assembly 2210. For example, the fuse 2214 may be configured to prevent the power source 2212 from generating enough heat to cause burns to the patient, damage the electronic assembly 2210, damage the battery, or damage the structural components of the smart implantable implant.

[0202] The first power switch 2216 is configured to connect the power source 2212 to one or more sensors 2222 or disconnect the power source from one or more sensors 2222 in response to a control signal from the controller 2232. For example, the controller 2232 may be configured to generate a control signal that has an open state, opening the switch 2216 and thus disconnecting power from one or more sensors 2222, and thus extending the life of the power source 2212, during a sleep mode or other low-power mode for power conservation. Similarly, the controller 2232 may also be configured to generate a control signal that has a closed state, closing the switch 2216 and thus connecting power to one or more sensors 2222. Such low-power modes may be directed only to one or more sensors 2222, or to sensors and one or more components of the electronics assembly 2210.

[0203] The second power switch 2218 is configured to connect the power source 2212 to the memory 2224 or disconnect the power source from the memory 2224 in response to a control signal from the controller 2232. For example, the controller 2232 may be configured to generate a control signal that has an open state, opening the switch 2218 during a sleep mode or other low-power mode to conserve power, thereby disconnecting power from the memory 2224 and thus extending the lifespan of the power source 2212. Similarly, the controller 2232 may also be configured to generate a control signal that has a closed state, closing the switch 2218 when "waking" from sleep mode or exiting another low-power mode, thereby connecting power to the memory 2224. Such low-power modes may be directed only to the memory 2224, or to the memory and one or more components of the electronics assembly 2210.

[0204] The clock and power management unit 2220 is preferably configured to generate a clock signal for one or more of the other components of the electronics assembly 2210, and also preferably to generate periodic commands or other signals (e.g., interrupt requests), in response to such periodic commands or other signals, the controller 2232 causes one or more components of the IRP 2203 to enter or exit sleep mode or other low-power mode. The clock and power management unit 2220 is also preferably configured to adjust the voltage from the power source 2212 and provide the adjusted power supply voltage to some or all of the other components of the electronics assembly 2210.

[0205] Examples of memory 2224 include volatile memory and non-volatile memory. For example, volatile memory can be configured to store the operating system and one or more applications executed by the controller 2232. Non-volatile memory is preferably configured to store configuration information for the IRP2203, store data written by the controller 2232, and provide data in response to read commands from the controller.

[0206] The IRP2203 medical device includes a communication interface that facilitates communication between the medical device and another device. The other device may be, for example, an external device located outside or away from the patient who received the medical device, such as a base station, or an internal device placed inside the patient's body who received the medical device. In either case, communication between the implanted medical device and another device, whether internal or external, is called intracellular communication. One or more modes of intracellular communication can be made possible by the communication interface of the IRP2203. As mentioned above, possible intracellular communication modes include 1) RF telemetry communication, 2) tissue conduction communication, such as galvanic coupling communication, and 3) data-over-sound communication, such as ultrasound or acoustic communication.

[0207] The communication interface generally includes a communication circuitry system 2225 associated with (but not necessarily associated with) the electronics assembly 2210 of the IRP2203. The communication circuitry system 2225 may include any hardware, firmware, software, or any combination thereof suitable for enabling one or more modes of internal communication. For this purpose, the communication circuitry system 2225 may include, for example, voltage regulators, current generators, oscillators, or signal generating circuits, resistors, capacitors, inductors, and other filtering circuits for processing received signals, as well as circuits for modulating and / or demodulating signals according to a communication protocol.

[0208] Depending on the internal communication mode, the communication circuit system 2225 may further include other switching circuit systems for selectively coupling or receiving signals from transistors or other transistors or transmitted signals to desired transceivers, such as antenna 2230 (which is for electromagnetic communication, e.g., RF telemetry communication), or electrodes 2231, 2233 (which can be used for tissue conduction communication), or acoustic transducer 2236 (which can be used for data-over-sound communication). Under the control of controller 2232, the communication circuit system 2225 can receive downlink communication signals from an external device or another implanted device and send uplink communication signals to such external device or implanted device. In addition, the communication circuit system 2225 can communicate with external devices and networked computing devices via computer networks, such as the Medtronic CareLink® network developed by Medtronic Public Limited Company (Medtronic, plc) in Dublin, Ireland.

[0209] Further details regarding RF telemetry communication, tissue conduction communication, and data-over-sound communication modes for internal communications are as follows:

[0210] The RF telemetry mode of the internal communication is made possible by an RF communication interface including an antenna 2230 and an RF telemetry circuit system, such as an RF transceiver 2226 and a filter 2228. Possible RF communication modes include far-field RF and near-field RF. The RF transceiver 2226 is preferably a conventional transceiver configured so that the controller 2232 (and optionally a fuse 2214) can communicate with another implanted medical device (not shown in Figure 22A) or a base station (not shown in Figure 22A) configured for a smart implantable device. For example, the RF transceiver 2226 may be any suitable form of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE)), and WiFi®, and may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi®), and may be configured to operate in a frequency band in the range of 1 MHz to 5.4 GHz, or in any other suitable range. In exemplary configurations of far-field RF communication, the frequency band is preferably 401-406 MHz or 2.4 GHz. In some embodiments, different frequencies can be used for different purposes. For example, in one configuration, 2.4 GHz can be used to wake up the equipment, while 400 MHz is used for communication.

[0211] For far-field RF communication, the antenna 2230 can be a monopole, dipole, folded dipole, meandering load, loop, small loop, chip-mounted MEMS, or helical antenna. Furthermore, far-field RF communication is best implemented using an antenna used for energy transmission. For example, antenna 144b in Figure 9B can be used for both RF energy transmission and RF communication.

[0212] Filter 2228 may be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. Antenna 2230 may be any antenna suitable for the frequency band in which the RF transceiver 2226 generates signals for transmission by the antenna, and suitable for the frequency band in which the base station (not shown in Figure 22A) generates signals for reception by the antenna.

[0213] The tissue conduction communication (TCC) mode of internal communication is made possible by a TCC interface including a TCC circuit system 2238 and a pair of electrodes 2231, 2233. The pair of electrodes 2231, 2233 are preferably selected from the detection electrode 2221 and coupled to the TCC circuit system 2238 via an electrode switch 2223. In a modified example, the pair of electrodes may be electrodes 2231, 2233 which are the detection electrode 2221. The TCC interface allows the controller 2232 to communicate with another device having the same TCC interface as the IRP 2203. The other device may be an implanted medical device (not shown in Figure 22A) or a base station configured for a medical device (not shown in Figure 22A).

[0214] Tissue conduction communication depends on the ion content of the patient's tissues into which the smart medical device 2202 is implanted, and is therefore often called galvanic communication. The ion content of the tissues provides an electrical communication medium for sending and receiving information to and from the smart medical device. To communicate in transmit mode, the TCC circuit system 2238 applies voltage to electrodes 2231 and 2233 so that a current flows between these electrodes and the corresponding electrical signal and propagates through the tissue. The propagating current can be detected by a receiving device (not shown in Figure 22A) by measuring the voltage generated between the two electrodes. To communicate in receive mode, the TCC circuit system 2238 measures the voltage applied to electrodes 2231 and 2233.

[0215] When TCC communication is employed to facilitate communication, the detection attachment and other devices that send and receive information to and from the detection attachment have relevant hardware, relevant firmware, relevant software, or any combination thereof suitable for enabling such communication. TCC transmission and related hardware, firmware, and software have been described and are preferably included in the smart implantable device of the present invention. For this, see, for example, U.S. Patent Application Publications 2016 / 213939, 2018 / 207429, 2019 / 160290, 2019 / 160291, 2019 / 160292, and 2019 / 184181. For example, from one perspective, the TCC circuit system 2238 is preferably coupled to one or more electrodes 2231, 2233, and the circuit system is preferably configured to allow the TCC interface to switch between a transmit mode in which it transmits TCC signals and a receive mode in which it receives TCC signals from another similarly configured device.

[0216] The data-over-sound mode for internal communication is made possible by a data-over-sound communication interface including a data-over-sound circuit system 2240 and at least one acoustic transducer 2236. The data-over-sound communication interface allows the controller 2232 to communicate with another device having the same data-over-sound communication interface as the IRP 2203. The other device may be a base station configured for an implanted medical device or a smart implantable device.

[0217] When data-over-sound communication is employed to facilitate communication, the smart medical device and other devices that send and receive information to and from the smart medical device have relevant hardware, relevant firmware, relevant software, or any combination thereof that is suitable for enabling such communication. Transmission by data-over-sound communication and the relevant hardware, firmware, and software have been described and are preferably included in the smart implantable medical device of the present invention. For this, see, for example, U.S. Patent No. 7,489,967 and U.S. Patent Application Publications 2010 / 0249882(A1) and 2013 / 0033966(A1). For example, in one view, the data-over-sound circuit system 2240 is preferably coupled to the acoustic transducer 2236 and comprises a circuit system that allows the data-over-sound communication interface to switch between a transmission mode in which it transmits an ultrasonic signal and a reception mode in which it receives an ultrasonic signal from another similarly configured device.

[0218] The controller 2232 may be any suitable microcontroller or microprocessor, which is configured to control the configuration and operation of one or more other components of the electronic assembly 2210. For example, the controller 2232 is configured to control one or more sensors 2222,2229 to detect relevant measurement data and to store the measurement data generated by one or more sensors in memory 2224. The controller 2232 is also configured to generate messages that can be communicated through one or more forms of communication interfaces. For example, in the case of RF telemetry communication, the controller 2232 creates a message containing the stored data as a payload, packets such a message, and provides the message packets to the RF transceiver 2226 for transmission to a base station (not shown in Figure 22A). The controller 2232 is also preferably configured to execute commands received from the base station (not shown in Figure 22A) via a communication interface, such as antenna 2230, filter 2228, and RF transceiver 2226. For example, the controller 2232 may be configured to receive configuration data from the base station and to provide setting data to the components of the electronics assembly 2210 to which the base station has directed the setting data. When the base station directs the setting data to the controller 2232, the controller is configured to configure itself in response to the setting data.

[0219] In one respect, the medical devices of the present invention are sterile. In another respect, the medical devices of the present invention are subjected to sterilization procedures to provide sterile medical devices. Among various options, the medical devices may be sterilized by exposing them to ethylene oxide, ionizing radiation, autoclave, ultraviolet radiation, or dry heating using an alcohol solution. Suitable alcohol solutions include, but are not limited to, methanol, ethanol, isopropanol, and aqueous solutions thereof. The ionizing radiation used may include gamma radiation and electron beam radiation. The dose of ionizing radiation used for sterilization may exceed 20 kGy, 25 kGy, 30 kGy, 35 kGy, or 40 kGy. With respect to devices sterilized using ethylene oxide, the sterilized devices may preferably conform to ISO 10993-7 regarding the presence of residual ethylene oxide and ethylene chlorohydrin.

[0220] The medical device of the present invention may be in a non-sterile form. From one perspective, a non-sterile medical device is subject to USP <1111> The requirements are met. From one perspective, non-sterile instruments have a total aerobic microorganism count (cfu / g or cfu / mL) of 10² or less. From another perspective, they have a total fungal count (cfu / g or cfu / mL) of less than 10¹. From another perspective, non-sterile instruments have a total aerobic microorganism count (cfu / g or cfu / mL) of 10² or less and a total fungal count (cfu / g or cfu / mL) of 10¹ or less. Non-sterile contraceptives are not contaminated with Pseudomonas aeruginosa, Staphylococcus aureus, or Candida albicans.

[0221] Implant placement location Referring to Figures 24A and 24B, in some embodiments, the structure 2402 of the medical device 2400 is configured to be implanted to bridge the fracture site 2408 of the bone 2410. For example, in Figure 24A, the medical device 2400 is preferably one of two devices positioned parallel to each other to bridge the femoral neck fracture 2408. In another embodiment shown in Figure 24B, the medical device 2400 is preferably one of three devices that form a triangle and are implanted to bridge the femoral head hip fracture site 2408, with the other two devices 2422, 2424 being merely tubular screws. In this embodiment, the medical device 2400 is implanted at the apex of the triangle at the location with the least load among the three locations. In another embodiment, the medical device 2400 may be implanted solely for the purpose of monitoring the progress of bone healing, and such a medical device does not provide any support or load-bearing function related to orthopedic treatment provided by other devices. For this purpose, the medical device 2400 is preferably implanted in the center of the surrounding orthopedic support devices, for example, at the center of a triangle, while the orthopedic support devices are implanted at each vertex of the triangle.

[0222] Referring to Figure 24C, in some embodiments, the medical device 2400 has a pair of smart structures 2402, 2404, each smart structure being implanted through corresponding holes in a plate 2406 that bridges a bone 2410, for example, a fracture site 2408 of the bone 2410, for example, a fracture site of the humerus.

[0223] Referring to Figures 24D and 24E, in some embodiments, the medical device 2400 is a structure 2402, such as a rod or pin, configured to be implanted to bridge a fracture site 2408 of bone 2410. For example, in Figure 24D, the structure 2402 of the medical device 2400 is a push rod that bridges a distal fibular fracture site. In Figure 24E, the structure 2402 of the medical device 2400 is one of four percutaneous pins that bridge a fracture site of the humeral neck.

[0224] Fracture Characterization Devices and Methods Figures 25A and 25B are a flowchart and a schematic diagram, respectively, of a method for characterizing a fracture site. This method is preferably carried out by one of the smart medical devices disclosed herein and configured as described below.

[0225] In block 2502, a smart medical device 2520 with multiple electrodes is implanted in bone tissue 2522, with the first electrode 2524 and the second electrode 2526 positioned opposite each other on the fracture site 2528. In some methods, multiple electrodes are implanted by implanting a lumen-equipped sheath structure in the bone tissue and across the fracture site. After implanting the sheath structure, an electronics cartridge containing a detection module and other electronics is inserted into the lumen. In some methods, the sheath structure has multiple electrodes, which are coupled to the detection module when the electronics cartridge is inserted into the lumen. In some methods, multiple electrodes are provided in the electronics cartridge, and these electrodes interface with the bone tissue through holes in the side walls of the sheath structure or through openings at the ends of the sheath structure. In some methods, multiple electrodes are implanted by implanting a preloaded medical device having a structure with multiple electrodes, a detection module, and other electronics coupled to the multiple electrodes.

[0226] In block 2504, multiple measurements of the electrical properties of the tissue are obtained over time by a first electrode 2524 and a second electrode 2526 located opposite each other to the fracture site 2528. The electrical properties of the tissue are best represented by impedance measurements, and these measurements are obtained by applying signals of different frequencies to the first electrode 2524 and measuring the tissue impedance in accordance with EIS technique.

[0227] Block 2506 processes the measured values ​​to determine the healing status of the fracture site, such as union, risk of nonunion, and characterization of the fracture site 2528 corresponding to nonunion.

[0228] Block 2508 transmits multiple measurements of the electrical properties of the tissue, or characterization of the fracture site 2528, to an external device.

[0229] Figures 26A and 26B are a flowchart and a schematic diagram, respectively, of a method for characterizing a fracture site. This method is preferably carried out by one of the smart medical devices disclosed herein and configured as described below.

[0230] In block 2602, a smart medical device 2620 with multiple electrodes is implanted in bone 2622, with the first electrode 2624 and the second electrode 2626 each positioned in the gap 2630 of the fracture site 2628. In some methods, multiple electrodes are implanted by implanting a lumen-equipped sheath structure into the bone tissue at the fracture site. After implanting the sheath structure, an electronics cartridge containing a detection module and other electronics is inserted into the lumen. In some methods, the sheath structure has multiple electrodes, which are coupled to the detection module when the electronics cartridge is inserted into the lumen. In some methods, multiple electrodes are provided in the electronics cartridge, and these electrodes interface with the bone tissue through holes provided in the side wall of the sheath structure. In some methods, multiple electrodes are implanted by implanting a preloaded medical device having multiple electrodes, a detection module, and other electronics coupled to the multiple electrodes.

[0231] In block 2604, multiple measurements of the electrical properties of the tissue are obtained over time by a first electrode 2624 and a second electrode 2626 located within the gap 2630 of the fracture site 2628. The electrical properties of the tissue are best represented by impedance measurements, and these measurements are obtained by applying signals of different frequencies to the first electrode 2624 and measuring the tissue impedance in accordance with EIS technique.

[0232] In block 2606, the measured quantity is processed to determine the healing state of the fracture site, such as healing, the risk of non-union, and the characterization of the fracture site 2628 corresponding to non-union.

[0233] In block 2608, a plurality of measured quantities of the electrical properties of the tissue or the characterization of the fracture site 2628 are transmitted to an external device.

[0234] Referring to FIG. 26B, the smart medical device 2620 has a first set of electrodes located on a first side of the shaft 2632 of the medical device and a second set of electrodes located on a second side of the shaft spaced from the first side. This embodiment of the medical device may be based on, for example, the embodiments of FIGS. 21A and 21B, but may be modified to have four pin electrodes forming two sets. Continuing to refer to FIG. 26B, the smart medical device 2620 is placed within the patient's bone 2622 such that the first set of electrodes and the second set of electrodes straddle the fracture site 2628 and at least one electrode belonging to each set is located within the gap 2630. The electrodes are arranged on the shaft 2632 such that the first electrode 2624 is located on one side of the shaft and the second electrode 2626 is located on the other side of the shaft. The shaft 2632 may be insulated (e.g., anodized titanium). Thereby, an electrical path 2634 from the first electrode 2624 to the second electrode 2626 is created through the healing bone within the gap 2630. Thereby, a large change in impedance occurs when the fracture site is healing. However, the electrical path 2634 may be confined to an area located immediately around the shaft 2632. Therefore, in order to well understand the healing condition over the entire fracture site, a number of medical devices 2620a, 2620b, 2620c of this style may be employed to place a number of pairs of electrodes within the gap 2630 at a number of locations of the gap cross-section, thereby collecting a set of impedance measurement values at different locations of the gap. [[ID=]10]

[0235] Figures 27A and 27B are respectively a flowchart and a schematic diagram of a method for characterizing a fracture site. This method may be implemented by one of the smart medical devices configured as disclosed herein and further described below.

[0236] In block 2702, a smart medical device 2720 having a plurality of electrodes is implanted into a bone 2722 such that each of a first linear electrode 2724 and a second linear electrode 2726 straddles a gap 2730 of a fracture site 2728. The linear electrodes 2724, 2726 have a length of at least 1 mm. In some methods, a plurality of electrodes are implanted by implanting a cannula structure having a lumen into bone tissue at the fracture site. After implanting the cannula structure, an electronics cartridge having a detection module and other electronics is inserted into the lumen. In some methods, the cannula structure has a plurality of electrodes that couple to the detection module upon insertion of the electronics cartridge into the lumen. In some methods, a plurality of electrodes are provided within the electronics cartridge and interface with bone tissue through slots provided in the sidewall of the cannula structure. In some methods, a plurality of electrodes are implanted by implanting a preloaded medical device having a structure with a plurality of electrodes, a detection module, and other electronics coupled to the plurality of electrodes.

[0237] In block 2704, a plurality of measured quantities of the electrical properties of tissue are obtained over time by the first linear electrode 2724 and the second linear electrode 2726 straddling the gap 2730 of the fracture site 2728. The electrical properties of the tissue may correspond to impedance measurements, and the measured quantities are obtained by applying signals of different frequencies to the first linear electrode 2724 and measuring the tissue impedance in accordance with EIS technology.

[0238] In block 2706, the measured quantities are processed to determine a characterization of the healing state of the fracture site, such as healing, risk of nonunion, and characteristics of the fracture site 2728 corresponding to nonunion.

[0239] Block 2708 transmits multiple measurements of the electrical properties of the tissue, or characterization of the fracture site 2728, to an external device.

[0240] Referring to Figure 27A, the smart medical device 2720 has a first linear electrode 2724 located on the first side of the shaft 2732 of the medical device and a second linear electrode 2726 located on the second side of the shaft, spaced apart from the first side. This embodiment of the medical device is preferably based on the embodiments in Figures 13A to 13D, for example, but is preferably modified to have two linear electrodes, each configured to penetrate each other's slots located on opposite sides of the sheath-like structure. Continuing to refer to Figure 27B, the smart medical device 2720 is placed in the patient's bone 2722 so that the first linear electrode 2724 and the second linear electrode 2726 straddle the fracture site 2628. The linear electrodes 2724 and 2726 are positioned on the shaft 2732 such that these electrodes are located on opposite sides of the shaft. The shaft 2632 is preferably insulated (e.g., anodized titanium). This creates an electrical current path 2734 from the first linear electrode 2724 to the second linear electrode 2726 via a local region around the shaft 2732. Since the linear electrodes 2724 and 2726 are in contact with the bone 2722 on both sides of the fracture site, the electrical current path 2734 passes through the healing bone at the fracture site as well as through the bone on both sides of the fracture site.

[0241] The illustrative circuit diagrams show the initial state 2729 of the fracture site 2728 and the healing state 2731 of the fracture site. When the bone is healing, the impedance of the gap 2730 of the fracture site 2728 changes from low resistance RG in the fractured state to high resistance RG' in the healing state, thereby allowing the smart medical device 2720 to determine whether healing has occurred in a local area around the shaft 2732. When two linear electrodes 2724, 2726 are placed on each side of the shaft 2732, the influence of electrode contact resistance is removed from this measurement using a four-wire impedance measurement method. This embodiment tends to measure the degree of healing only in a local area around the shaft 2732. Therefore, in order to get a good understanding of the degree of healing across the entire fracture site, it is better to employ multiple medical devices of this style and place multiple pairs of linear electrodes across the gap 2730 at multiple locations in the gap cross section, thereby collecting sets of impedance measurements at different locations in the gap.

[0242] In one view, the present invention provides a method for treating a fracture in bone tissue, the method comprising the steps of identifying the fracture site in the bone tissue and inserting a medical device disclosed herein into the bone tissue, the medical device being inserted across the fracture site. The fracture site may be identified, for example, by X-ray. In one embodiment, the medical device is a screw. The medical device may be inserted into the bone tissue according to standard techniques used for inserting a sheath screw into the bone containing the fracture site. Optionally, the method further includes the step of characterizing the fracture site with the medical device.

[0243] In one view, the present invention provides a method for characterizing a fracture site in bone tissue, the method comprising the steps of identifying a fracture site in bone tissue and inserting a medical device disclosed herein into the bone tissue, the medical device being inserted across the fracture site, and the method further comprises a method for characterizing the fracture site with a sensor placed within the medical device. The fracture site may be identified, for example, by X-ray. In one embodiment, the medical device is a screw. The medical device may be inserted into the bone tissue according to standard techniques used for inserting a sheath screw into bone containing a fracture site.

[0244] Communication with smart medical devices A smart medical device is best situated within an environment that communicates with it. An example environment is an operating room, where the smart medical device is implanted in the patient by a healthcare professional. Another example environment is the patient's home, where the smart medical device is already implanted in the patient. Yet another example environment is a doctor's office, where the patient with the implanted smart medical device is present, for example, for evaluation. The following is a detailed description of the example environment within the patient's home. However, the features and connectivity described also exist analogously in other environments where the patient with the implanted smart medical device is present, such as an operating room or a doctor's office, which are also described herein, though not in as much detail.

[0245] Figure 28 is a diagram illustrating the smart medical device environment 2800, including features present in the patient's home. In this environment, a smart medical device 2802 having an implantable reporting processor (IRP) 2803 is implanted in the patient's body (not shown). The detection capabilities and associated electronic assembly of the smart medical device of the present invention may be collectively referred to as the implantable reporting processor (IRP). The IRP is a component of the smart medical device of the present invention, in which case the smart medical device has an IRP. The antenna may or may not be a component of the IRP. Similarly, the power source may not be a component of the IRP. The implantable reporting processor 2803 is arranged and configured to collect data, for example, medical and health data relating to the patient to whom the smart medical device is associated, as well as operational data of the smart medical device 2802 itself. The smart medical device 2802 communicates with one or more home base stations 2804 or one or more external smart devices 2805 during different monitoring stages of the patient.

[0246] The smart medical device 2802 has one or more sensors that collect information and data, including medical and health data about the patient to whom the smart medical device is associated, as well as operational data of the smart medical device 2802 itself. The smart medical device 2802 collects data at various different times and at various different rates during the patient monitoring process, and such smart medical device can optionally store such data in memory until this data is transmitted out of the patient's body. In some embodiments, the smart medical device 2802 can operate at multiple different stages throughout the patient monitoring process, with a large amount of data collected immediately after the smart medical device 2802 is implanted in the patient's body, and less data collected as the patient is healing and thereafter.

[0247] The amount and type of data collected by the smart medical device 2802 may vary from patient to patient, and may even change within a single patient. For example, a healthcare professional studying data collected by the smart medical device 2802 for a particular patient can adjust or control how the smart medical device 2802 collects future data.

[0248] The amount and type of data collected by the smart medical device 2802 may differ for different body parts, different forms of patient conditions, different patient demographics, or other differences. As a variation or additional example, the amount and type of data collected may change over time based on other factors, such as how the patient is healing or feeling, how long the monitoring process is estimated to last, how much power remains in the smart medical device 2802 and how much power should be saved, the type of movement being monitored, the body part being monitored, etc. In some cases, the collected data may be supplemented with personal descriptive information provided by the patient, such as subjective pain data, metric data on quality of life, comorbidities, and the patient's perceptions or expectations regarding the smart medical device 2802.

[0249] Once the smart medical device 2802 is implanted in the patient's body and the patient returns home, the smart medical device can begin communicating outside the patient's body within the home environment. Communication may be with, for example, a home base station 2804, an external smart device 2805 (e.g., the patient's smartphone), a connected personal assistant 2807, or two or more of the home base station, external smart device, and connected personal assistant that can communicate with the smart medical device 2802. The smart medical device 2802 can collect data at a predetermined rate and time, a variable rate and time, or at a different controllable rate and time. Data collection may begin when the smart medical device 2802 is initialized in the operating room, when instructed by a healthcare professional, or at some later point in time.

[0250] At least some of the data collected by the smart medical device 2802 can be transmitted directly to the home base station 2804, directly to the external smart device 2805, directly to the connected personal assistant 2807, to the base station via one or both of the smart device and the connected personal assistant, to the smart device via one or both of the base station and the connected personal assistant, or to the connected personal assistant via one or both of the smart device and the base station. In this case, "one or both" means via an item alone and via both items serially or in parallel. For example, data collected by the implanted smart medical device 2802 can be transmitted to the home base station 2084 via the external smart device 2805 alone, via the connected personal assistant 2807 alone, serially via the external smart device and the connected personal assistant, serially via the connected personal assistant and the external smart device, and directly, and possibly simultaneously via both the external smart device and the connected personal assistant.

[0251] Similarly, data collected by the implanted smart medical device 2802 can be transmitted to the external smart device 2805 via the home base station 2804 alone, via the connected personal assistant 2807 alone, serially via the home base station and the connected personal assistant, serially via the connected personal assistant and the home base station, or directly, and possibly simultaneously, via both the home base station and the connected personal assistant. Further examples illustrate that data collected by the implanted smart medical device 2802 can be transmitted to the external smart device 2805 alone, via the home base station 2804 alone, serially via the external smart device and the home base station, serially via the home base station and the external smart device, or directly, and possibly simultaneously, via both the external smart device and the home base station, to the connected personal assistant 2807.

[0252] In various embodiments, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 periodically or at other times to check the network connectivity of the implanted smart medical device 2802 and determine whether the implanted smart medical device 2802 is within the communication range of one or more of the home base station, external smart device, and connected personal assistant. Based on the response from the implanted smart device 2802, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 confirm that the implanted smart medical device 2802 is within communication range and that it can send requests, commands, or other instructions to the implanted smart medical device 2802 to transmit the data collected by the smart medical device to one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807.

[0253] Each of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807 may, in some cases, each have a corresponding user interface as an option. The user interface may be formed as a multimedia interface that transmits one or more forms of multimedia information (e.g., video, audio, haptics, etc.) in one or two directions. The patient (not shown in Figure 28) or the patient's friend (not shown in Figure 28) can enter other data and capture data collected by the implanted smart medical device 2802 through the user interface of each of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807. The user may enter, for example, personal descriptive information (e.g., age changes, weight changes), changes in medical status, comorbidities, pain levels, quality of life, indicators of how the implanted smart medical device 2802 "feels", other subjective metric data, personal messages about healthcare professionals, etc. In these embodiments, the personally descriptive information may be entered by a keyboard, mouse, touchscreen, microphone, wired or wireless computing interface, or any other means of input. When collecting personally descriptive information, the personally descriptive information may include, or be otherwise associated with, a unique identifier of the information-implanted smart medical device 2802, a patient, a relevant healthcare professional, a relevant healthcare facility, etc.

[0254] In some of these cases, it is preferable that the user interface, as an option for one or more of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807, is also configured to send information related to the implanted smart medical device 2802, for example, from a healthcare professional to the user. In these cases, it is preferable that the information sent to the user is transmitted via a video screen, an audio output device, a haptic transducer, a wired or wireless computing interface, or some other similar means.

[0255] In embodiments in which one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 have a user interface, the user interface preferably includes an internal user interface arranged to enable communicative coupling to a patient portal device. The patient portal device may be a smartphone, tablet, wearable device, weight or other health measuring device (e.g., thermometer, scale, etc.), or any other computing device capable of wired or wireless communication. In these cases, the user can enter personally descriptive information and also receive information related to the implanted smart medical device 2802.

[0256] The home base station 2804 transmits data collected using the patient's home network 2806 to the cloud 2808. The home network 2806 may be a local area network, which enables access from the patient's home to a wide area network, such as the internet. In some embodiments, the home base station 2804 can connect to the home network 2806 and access the internet using a Wi-Fi connection. In other embodiments, for example, the home base station 2804 may be connected to the patient's home computer (not shown in Figure 28) via a USB connection, which itself is connected to the home network 2806.

[0257] The external smart device 2805 can directly communicate with the implanted smart medical device 2802 by, for example, a Bluetooth (registered trademark) compliant signal, and can transmit the collected data to the cloud 2808 using the patient's home network 2806 or can directly communicate with the cloud via, for example, a cellular network. As a variant, the external smart device 2805 is configured to directly communicate with one or both of the home base station 2804 and the connected personal assistant 2807 by, for example, a Bluetooth (registered trademark) compliant signal, and such an external smart device is not configured to directly communicate with the implanted smart medical device 2802.

[0258] Furthermore, the connected personal assistant 2807 can directly communicate with the implanted smart medical device 2802 by, for example, a Bluetooth (registered trademark) compliant signal, and can transmit the collected data to the cloud 2808 using the patient's home network 2806 or can directly communicate with the cloud via, for example, a modem / Internet connection method or a cellular network. As a variant, the connected personal assistant 2807 is configured to directly communicate with one or both of the home base station 2804 and the external smart device 2805 by, for example, a Bluetooth (registered trademark) compliant signal, and such a connected personal assistant 2807 is not configured to directly communicate with the implanted smart medical device 2802.

[0259] One or more of the home base station 2804, external smart devices 2805, and connected personal assistants 2807 also transmit collected data to the cloud 2808 and can obtain data, commands, or other information from the cloud 2808 directly or via the home network 2806. One or more of the home base station 2804, external smart devices 2805, and connected personal assistants 2807 can provide some or all of the received data, commands, or other information to the implanted smart medical device 2802. Examples of such information include, but are not limited to, configuration update information, diagnostic requests to determine whether the implanted smart medical device 2802 is functioning properly, data collection requests, and other information.

[0260] Cloud 2808 may include one or more server computers or databases to collect data from implanted smart medical devices 2802, possibly from other assemblies (not shown), along with personally descriptive information collected from patients (not shown in Figure 28), and possibly from other patients. In this way, Cloud 2808 can generate a wide variety of metrics regarding data collected from each of multiple assemblies implanted in different patients. This information can be useful in determining whether the assemblies are functioning properly. The collected information may also be useful for other purposes, such as identifying which particular devices are not functioning properly, determining whether procedures or conditions associated with smart medical devices are helping the patient (e.g., whether a knee replacement is working properly and reducing the patient's pain), and determining other medical information.

[0261] Referring further to Figure 28, modified embodiments can be envisioned. For example, one or more of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807 can be omitted from the smart medical device environment 2800. Furthermore, each of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807 may be configured to communicate with one or both of the implanted smart medical device 2802 and the cloud 2808 via one or more other of the base station, smart device, and connected personal assistant. Furthermore, the external smart device 2805 can be temporarily contracted as an interface to the implanted smart medical device 2802, and the external smart device may be any suitable device other than a smartphone, such as a smartwatch, a smart patch, and any IoT device that can act as an interface to the implanted smart medical device 2802, such as a coffee pot.

[0262] In addition, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can function as a communication hub for multiple prostheses implanted in the body of one or more patients. Furthermore, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can automatically order or reorder prescriptions or medical supplies (e.g., knee braces) in response to patient input or implanted prosthesis input (e.g., pain level, instability level), provided that a medical professional or insurance company has given prior authorization for such ordering or reordering. As a variation, one or more of the base station, smart device, and connected personal assistant may be configured to request authorization from a medical professional or insurance company to place an order or reorder. Furthermore, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 may be equipped with a personal assistant, such as Alexa® or Siri®.

[0263] Referring to Figure 28, the smart medical device environment was explained in relation to the patient's home, but the same principle applies when the environment is an operating room or a doctor's office. For example, in connection with a medical procedure, the implanted smart medical device 2802 can be implanted in the patient's body within the operating room environment. The implanted smart medical device 2802 communicates with the operating room base station (similar to a home base station) at the same time as the medical procedure. After the patient has fully recovered from the medical procedure and returned home, the implanted smart medical device 2802 is configured to communicate with the home base station 2804. Then, at another point in time, the implanted smart medical device 2802 is configured to communicate with the doctor's office base station when the patient visits a doctor for a follow-up examination. In any case, the implanted smart medical device 2802 communicates with each base station via a short-range network protocol, such as Medical Device Communication Services (MICS), Medical Device Wireless Communication Services (MedRadio), or any other wireless communication protocol suitable for use with the smart medical device 2802.

[0264] For example, the implantation of the implantable smart medical device 2802 into the patient's body is preferably performed in an operating room. An operating room as used herein may be any clinic, room, building, or facility in which the smart medical device 2802 is implanted into the patient's body. For example, the operating room may be a typical operating room in a hospital, an operating room in a surgical clinic or doctor's office, or any other surgical site in which the smart medical device 2802 is implanted into the patient's body.

[0265] The operating room (similar to the home base station in Figure 28) is used to configure and initialize the implanted smart medical device 2802 in relation to the smart medical device 2802 implanted in the patient's body. A communication relationship is established between the smart medical device 2802 and the operating room base station, for example, based on polling signals transmitted by the operating room base station and response signals transmitted by the smart medical device 2802.

[0266] During the establishment of communication infrastructure, which is often performed prior to the implantation of the smart medical device 2802, the operating room base station transmits initial setup information to the smart medical device 2802. This initial setup information may include, but is not limited to, a time stamp, a date stamp, identification of the type and location of the smart medical device 2802, information about other implants associated with the smart medical device, information about the surgeon, patient identification, and operating room information.

[0267] In some embodiments, the initial setup information is transmitted unidirectionally, and in other embodiments, the initial setup is transmitted bidirectionally. The initial setup information can define at least one parameter related to data collection by the smart medical device 2802. For example, the setup information can identify setting values ​​for one or more sensors provided on the smart medical device 2802 for each of one or more operating modes. The setup information may also preferably include other control information, such as the initial operating mode of the smart medical device 2802, specific events that trigger changes in operating modes, wireless setting values, data collection information (e.g., how much data the smart medical device 2802 activates to collect, how much data the smart medical device collects, how much data to collect), identification information for the home base station 2804, the smart device 2805, the connected personal assistant 2807, and other control information related to the implantation or operation of the smart medical device 2802. Examples of connected personal assistants 2807, sometimes also called smart speakers, include Amazon Echo®, Amazon Dot®, Google Home®, Phillips® patient monitors, Comcast health tracking speakers, and Apple HomePod®.

[0268] In some embodiments, the configuration information may be pre-stored in the operating room base station or the patient's computing device. In other embodiments, a surgeon, surgical technician, or any other healthcare professional may input control information and other parameters to the operating room base station for transmission to the smart medical device 2802. In at least one such embodiment, the operating room base station may communicate with an operating room configuration computing device. The operating room configuration computing device includes an application with a graphical user interface that allows a healthcare professional to input configuration information for the smart medical device 2802. In various embodiments, the application running on the operating room configuration computing device may have some of the default configuration information, which may or may not be adjustable by the healthcare professional.

[0269] The operating room configuration computing device transmits configuration information to the operating room base station via a wired or wireless network connection method (e.g., USB connection method, Bluetooth connection method, Bluetooth Low Energy (BTLE) connection method, or Wi-Fi connection method), and such wired or wireless network connection method transmits the configuration information to the smart medical device 2802.

[0270] The operating room configuration computing device can also display information regarding the smart medical device 2802 or the operating room base station to the surgeon, surgical technician, or healthcare professional. For example, the surgical configuration computing device may display error information if the smart medical device 2802 is unable to obtain or access configuration information, if the smart medical device 2802 is unresponsive, if the smart medical device 2802 detects a problem with one of its sensors or radios during initial self-testing, if the operating room base station is unresponsive or malfunctioning, or for other reasons.

[0271] Although the operating room base station and the operating room configuration computing device have been described as separate devices, the embodiments are not limited thereto. In contrast, the functions of the operating room configuration computer device and the operating room base station may be included in a single computing device or in separate devices, as shown in the figures. In this case, in one embodiment, medical personnel can directly input configuration information into the operating room base station.

[0272] After a smart medical device is implanted in a patient's body, the patient should periodically visit a physician for follow-up evaluations. From one perspective, the present invention can provide a physician's clinic environment (similar to the home environment described herein), in which case the implanted smart medical device communicates with the clinic environment. During these visits, data stored in memory can be accessed and / or specific data can be requested and obtained as part of the monitoring process.

[0273] For example, at various times throughout the monitoring process, the patient may be asked to visit a healthcare professional for a follow-up appointment. This healthcare professional may be the surgeon who implanted the smart medical device 2802 in the patient's body or another healthcare professional who oversees the monitoring process, physiotherapy, and the patient's recovery. For various reasons, the healthcare professional may want to collect real-time data from the smart medical device 2802 within a controlled environment. In some cases, the request to visit the healthcare professional may be sent via a two-way user interface as one or more of the following options: the home base station 2804, the external smart device 2805, and the connected personal assistant 2807.

[0274] The healthcare professional transmits additional data between the physician's clinic base station (similar to the home base station shown in Figure 28) and the smart medical device 2802, using a physician's clinic base station that communicates with the smart medical device 2802. In a modified or additional example, the healthcare professional transmits commands to the smart medical device 2802 using a physician's clinic base station (not shown in Figure 28). In some embodiments, the physician's clinic base station commands the smart medical device 2802 to enter high-resolution mode, temporarily increasing the rate or type of data collected in a short period of time. High-resolution mode commands the smart medical device 2802 to collect a different amount (e.g., a large amount) of data while the healthcare professional is also monitoring the patient.

[0275] In some embodiments, a physician's clinic base station allows healthcare professionals to input events or pain markers, and these events or pain markers can be synchronized with high-resolution data collected by the smart medical device 2802. For example, a healthcare professional may have a patient walk on a treadmill while the smart medical device 2802 is in high-resolution mode. While the patient is walking, they may complain of pain. The healthcare professional can click a pain marker button on the physician's clinic base station to display the patient's discomfort. The physician's clinic base station records the marker and the time the marker was input. By synchronizing the timing of this marker with the timing of the collected high-resolution data, healthcare professionals can analyze the data to investigate and pinpoint the cause of the pain.

[0276] In other embodiments, the physician's clinic base station can provide updated configuration information to the smart medical device 2802. The smart medical device 2802 stores this updated configuration information, which can be used to adjust parameters associated with data collection. For example, if a patient is recovering, a healthcare professional can instruct the smart medical device 2802 to reduce the frequency of data collection. Conversely, if a patient is experiencing unexpectedly severe pain, the healthcare professional may instruct the smart medical device 2802 to collect additional data over a specified period (e.g., several days). The healthcare professional can use the additional data to diagnose and address specific problems. In some cases, the additional data may include personally descriptive information provided by the patient after they have left the healthcare professional's care, and such additional data is no longer within the range of the physician's clinic base station. In these cases, the personally descriptive information can be collected or transmitted via one or more of the home base station 2804, external smart devices 2805, and connected personal assistants 2807. The firmware in the smart medical device and / or base station acts as a safety safeguard that limits the improved monitoring period, ensuring that the smart medical device 2802 maintains sufficient power to last throughout the patient's implant lifecycle.

[0277] In various embodiments, the physician's clinic base station can communicate with a physician's clinic configuration computing device (similar to an operating room computing device). The physician's clinic configuration computing device includes an application with a graphical user interface that allows healthcare professionals to input commands and data. It is preferable that some or all of the commands, data, and other information are later transmitted to the smart medical device 2802 via the physician's clinic base station. For example, in some embodiments, a healthcare professional can issue commands to the smart medical device 2802 using the graphical user interface, thereby entering its high-resolution mode. In other embodiments, a healthcare professional can input or modify configuration information for the smart medical device 2802 using the graphical user interface. The physician's clinic configuration computing device transmits information (e.g., commands, data, or other information) to the physician's clinic base station via a wired or wireless network connection (e.g., USB connection, Bluetooth connection, or Wi-Fi connection), and the physician's clinic base station transmits some or all of the configuration information to the smart medical device 2802.

[0278] The physician's clinic configuration computing device can also display to healthcare professionals other information relating to the smart medical device 2802, to the patient (e.g., personally descriptive information), or to the physician's clinic base station. For example, the physician's clinic configuration computing device can display high-resolution data collected by the smart medical device 2802 and transmitted to the physician's clinic base station. The physician's clinic configuration computing device can also display error information if the smart medical device 2802 is unable to store or access configuration information, if the smart medical device 2802 is unresponsive, if the smart medical device 2802 detects a problem with one of its sensors or radios, if the physician's clinic base station is unresponsive or malfunctioning, or for other reasons.

[0279] In some embodiments, the physician's clinic-configured computing device preferably has access to the cloud 2808. In at least one embodiment, a healthcare professional can use the physician's clinic-configured computing device to access data stored in the cloud 2808 that has been previously collected by the smart medical device 2802 and transmitted to the cloud 2808 via either or both of the home base station 2804 and / or an external smart device 2805. Similarly, the physician's clinic-configured computing device can transmit high-resolution data obtained from the smart medical device 2802 to the cloud 2808 via the physician's clinic base station. In some embodiments, the physician's clinic base station preferably has internet access and can transmit high-resolution data directly to the cloud 2808 without using the physician's clinic-configured computing device.

[0280] In various embodiments, healthcare professionals can update the configuration information of the smart medical device 2802 when the patient is not at the healthcare professional's clinic. In these cases, the healthcare professional can use a physician's clinic configuration computing device (not shown in Figure 28) to transmit the updated configuration information to the smart medical device 2802 via the cloud 2808. One or more of the home base station 2804, external smart devices 2805, and connected personal assistants 2807 can obtain the updated configuration information from the cloud 2808 and send the updated configuration information to the cloud. This allows healthcare professionals to remotely adjust the operating status of the smart medical device 2802 without the patient having to go to the healthcare professional's clinic. This also allows healthcare professionals to send messages to patients in response to personally descriptive information provided by the patient and sent to the physician's clinic base station (not shown in Figure 28) via one or more of the home base station 2804, external smart devices 2805, and connected personal assistants 2807. For example, if a patient says "I'm in pain" to the connected personal assistant 2807, the healthcare professional can issue a prescription for pain medication, which the connected personal assistant can then "speak" to inform the patient that "the doctor has called the patient's preferred pharmacy with a Vicodin (registered trademark) prescription, and the prescription is ready for pickup anytime at 4pm."

[0281] Although the physician's clinic base station (not shown in Figure 28) and the physician's clinic configuration computing device (not shown in Figure 28) have been described as separate devices, the embodiments are not limited thereto. In contrast, the functions of the physician's clinic configuration computer device and the physician's clinic base station may be contained in a single computing device or separate devices (as shown). In this way, in one embodiment, healthcare professionals can directly input configuration information or markers into the physician's clinic base station and view high-resolution data (and synchronized marker information) from a display on the physician's clinic base station.

[0282] Some specific exemplary embodiments of the present invention, numbered for convenience, include the following: [Implementation item 1] It is a medical device, A structure having a lumen that extends through at least partially and configured to be at least partially implanted in the body, A medical device comprising an electronics cartridge that includes electronics and is configured to be inserted into the lumen after implantation of the above structure. [Implementation Section 2] The system further includes a sensor for measuring the electrical properties of tissue, and the sensor is Multiple electrodes, A medical device according to Embodiment 1, comprising the above-mentioned electronic cartridge and a detection module, wherein the detection module is coupled to the plurality of electrodes. [Embodiment 3] The above-mentioned plurality of electrodes include a first electrode and a second electrode, The medical device according to Embodiment 2, wherein the detection module is configured to allow the first electrode and the second electrode to function in either an application mode in which a signal is applied to the entire electrode, or a detection mode in which the impedance between the electrodes is detected. [Embodiment Item 4] The medical device according to Embodiment 3, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies. [Embodiment 5] The above sensor further includes an electrode switch, The plurality of electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode, which are switchably coupled to the detection module via the electrode switch. The medical device according to Embodiment 2, wherein the detection module is configured to enable an application mode in which a signal is applied to the first electrode and the second electrode, and to enable a detection mode in which the impedance between the third electrode and the fourth electrode is detected. [Implementation Section 6] The medical device according to Embodiment 5, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies. [Embodiment 7] The medical device according to Embodiment 2, wherein the electrical properties of the above-mentioned tissue include impedance measurements, and the medical device further comprises a controller configured to process the impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture. [Embodiment 8] The above healing state corresponds to one of fusion, suspected nonunion, and nonunion, as described in Embodiment 7 of the medical device. [Embodiment Item 9] The above-mentioned plurality of electrodes are associated with the above-mentioned structure and are arranged at intervals from each other so as to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site. The medical device according to Embodiment 2, wherein the electronic cartridge has a plurality of electrical contacts arranged to electrically couple to the plurality of electrodes when the electronic cartridge is inserted into the lumen of the structure. [Implementation item 10] The medical device according to Embodiment 2, wherein the plurality of electrodes are associated with the electronic cartridge and are spaced apart from each other to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site. [Initiative 11] The above structure has at least one hole penetrating the side wall, The medical device according to embodiment 10, wherein the plurality of electrodes are positioned on the electronics cartridge so as to align with the at least one hole when the electronics cartridge is inserted into the lumen of the structure. [Implementation item 12] The above structure has a distal end opening and a proximal end opening, The medical device according to embodiment 10, wherein the plurality of electrodes include a first electrode positioned on the electronics cartridge so as to be adjacent to the distal end opening when the electronics cartridge is inserted into the lumen of the structure, and a second electrode positioned on the electronics cartridge so as to be adjacent to the proximal end opening. [Embodiment 13] The above structure has a distal end opening, The medical device according to Embodiment 10, wherein the plurality of electrodes include a first electrode and a second electrode positioned on the electronic cartridge such that when the electronic cartridge is inserted into the lumen of the structure, each electrode is positioned distal to the distal end opening of the structure. [Embodiment Item 14] The above-mentioned lumen is configured to receive an implantation tool during implantation of the above-mentioned structure, as described in Embodiments 1 to 13 of the medical device. [Embodiment Item 15] The medical device according to embodiment 14, wherein the structure has a head having a recessed pocket that constitutes the head portion of the lumen, configured to receive a portion of the implant tool, thereby enabling the transmission of torque applied to the implant tool to the structure. [Implementation item 16] The above structure is a medical device according to embodiments 1 to 15, configured to be implanted in bone. [Embodiment Item 17] The above structure is configured to be implanted to bridge the fractured portion of the bone, as described in Embodiment 16. [Embodiment 18] The above structure is configured to be implanted through a hole provided in a plate that bridges the fractured portion of the bone, as described in Embodiment 16. [Implementation item 19] The above structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument, as described in Embodiments 1 to 18. [Embodiment Clause 20] The above structure is a medical device according to embodiments 1 to 19, having a shaft with an outer diameter in the range of 4 millimeters or more. [Implementation Clause 21] The medical device according to embodiments 1 to 20, wherein the above-mentioned lumen has a shaft portion having a diameter sized to accept at least a portion of the above-mentioned electronic cartridge. [Embodiment Section 22] The medical device according to embodiments 1 to 21, wherein each of the above-mentioned electronic cartridge and the above-mentioned lumen has substantially identical shape factors. [Embodiment 23] The shape factor of the electronic cartridge and the lumen, respectively, includes a head portion and a shaft portion, wherein the head portion has a larger diameter than the shaft portion, according to the medical device of embodiment 22. [Embodiment Section 24] The above structure and the above electronic cartridge include mechanical features that allow the electronic cartridge to be securely fixed within the lumen, as described in Embodiments 1 to 23. [Embodiment 25] The medical device according to Embodiment 24, wherein the above mechanical features consist of one of the following: a difference in shape factor between the head of the electronics cartridge and the head portion of the lumen of the structure; a protrusion associated with the electronics cartridge and a recess associated with the lumen of the structure; and an interlock feature associated with the shaft of the electronics cartridge that receives the adhesive and the inner wall of the structure that engages with the adhesive. [Embodiment Clause 26] The above structure and the above electronic cartridge have mechanical features that allow the electronic cartridge to be removed from the lumen without damaging the structural integrity of either the electronic cartridge or the above structure, as described in Embodiments 1 to 25. [Embodiment 27] The above mechanical features are those of a complementary screw thread, as described in Embodiment 26 of the medical device. [Embodiment 28] The medical device according to embodiments 1 to 27, wherein the electronics cartridge has a head and a shaft, and at least a portion of the electronics is contained in an electronics assembly disposed within the head.

[0283] [Embodiment Section 29] The medical device according to embodiments 1 to 28, wherein the electronics cartridge has a head and a shaft, and at least a portion of the electronics is contained in an electronics assembly disposed within the shaft. [Embodiment 30] The above structure has an outer surface, and one or more electrodes are located on the outer surface. The medical device according to embodiments 1 to 29, wherein the electronic cartridge has an outer surface and one or more electrical contacts provided on the outer surface that are configured to electrically couple to one or more electrodes when the electronic cartridge is inserted into the lumen. [Embodiment 31] The medical device according to embodiment 30, wherein the structure has a conductive substrate, one or more electrodes correspond to a conductive material associated with the sidewall of the conductive substrate, and one or more electrodes are electrically insulated from the conductive substrate by an insulating material. [Embodiment 32] The medical device according to embodiment 31, further comprising a feedthrough for one or more electrodes, wherein the feedthrough extends through the side wall of the conductive substrate and provides an electrical connection between the one or more electrodes and the interior of the structure. [Embodiment 33] The above structure has a conductive substrate that is at least partially covered with an insulating material, and one or more electrodes are The region of the conductive substrate not covered with the insulating material, and A medical device according to embodiment 30, which corresponds to one or more conductive materials located on top of the insulating material. [Embodiment 34] The medical device according to embodiment 30, wherein the structure has a substrate, and one or more electrodes correspond to a conductive material on the substrate. [Embodiment 35] The above substrate is made of a non-conductive material, as described in Embodiment 34 of the medical device. [Embodiment 36] The above substrate is made of conductive material. The medical device according to embodiment 34, wherein one or more electrodes correspond to a conductive material located on an insulating material. [Embodiment 37] The above structure has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end, according to Embodiment 30. [Embodiment 38] The medical device according to embodiment 30, wherein one or more electrodes are electrically insulated from each other and from the structure. [Embodiment 39] The above structure has one or more holes penetrating the side wall, The medical device according to embodiments 1 to 38, wherein the electronic cartridge has one or more electrodes positioned to align with one or more holes when the electronic cartridge is inserted into the lumen of the structure. [Embodiment Item 40] The medical device according to Embodiment 39, wherein each of the above structure and the above electronic cartridge is configured to align each of the one or more electrodes with a corresponding one of the one or more holes when the electronic cartridge is inserted into the lumen. [Embodiment Item 41] The medical device according to Embodiment 39, wherein the electronic cartridge has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end. [Embodiment Section 42] The medical device according to embodiment 39, wherein one or more electrodes are electrically insulated from each other. [Embodiment Item 43] The one or more holes mentioned above correspond to slots, The medical device according to embodiment 39, wherein the electronic cartridge has a shape factor that extends outward from the surface of the electronic cartridge and fits into the slot, and has an electrode assembly that includes one or more electrodes. [Embodiment Item 44] The medical device according to Embodiment 43, wherein the electrode assembly is biased with respect to the surface of the electronics cartridge so that the electronics cartridge can transition between a compressed state in which the outer surface of the electrode assembly is substantially coplanar with the surface of the electronics cartridge and an expanded state in which the outer surface of the electrode assembly is positioned above the surface of the electronics cartridge so as to penetrate the slot. [Embodiment Item 45] The medical device according to Embodiment 39, wherein the electrode is associated with the shaft of the electronics cartridge, and the electrode includes a recessed electrode surface relative to the surface of the shaft such that when inserted into the lumen of the structure, an empty space communicating with a hole is formed between the electrode surface and the inner wall of the structure. [Embodiment Item 46] The above structure has a distal end opening and a proximal end opening, The medical device according to embodiments 1 to 45, wherein the electronic cartridge has a first electrode positioned adjacent to the distal end opening and a second electrode positioned adjacent to the proximal end opening when the electronic cartridge is inserted into the lumen of the structure. [Embodiment Item 47] The above structure has a distal end opening, The medical device according to embodiments 1 to 46, wherein the electronic cartridge has a plurality of electrodes positioned on the electronic cartridge so as to be located distal to the distal end opening when the electronic cartridge is inserted into the lumen of the structure. [Embodiment 48] The above electronics include an antenna, as described in Embodiments 1 to 47 of the medical device. [Embodiment Item 49] The above-mentioned electronic cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The above antenna is related to the above shaft, as described in Embodiment 48 of the medical device. [Embodiment 50] The above-mentioned antenna has a conductive wire or trace wire extending along the length of the above-mentioned shaft, the medical device according to embodiment 49. [Embodiment 51] The above-mentioned antenna extends in a spiral pattern around the above-mentioned shaft, as described in embodiment 50 of the medical device. [Embodiment 52] The medical device according to Embodiment 51, wherein the antenna is electrically insulated from the outer surface of the shaft to avoid contact with the structure when the electronic cartridge is inserted into the lumen of the structure. [Embodiment 53] The above-mentioned electronic cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The above antenna is associated with the above head, as described in Embodiment 48 of the medical device. [Embodiment 54] The medical device according to embodiment 53, wherein the antenna has a conductive wire or trace wire extending along a plane parallel to the base of the head. [Embodiment 55] The above electronics include one or more power supplies, as described in Embodiments 1 to 54 of the medical device. [Embodiment 56] The above-mentioned electronic cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to embodiment 55, wherein one or more of the above-mentioned power sources are associated with the above-mentioned shaft. [Embodiment 57] The above-mentioned electronic cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to Embodiment 55, wherein one or more of the above-mentioned power sources are associated with the head. [Embodiment 58] The medical device according to Embodiment 55, wherein the one or more power sources include one or more batteries and capacitors. [Embodiment 59] The medical device according to Embodiment 55, wherein one or more of the above-mentioned power sources include an energy extraction device configured to extract energy by one of the following: electrostatic energy, wireless energy transfer, electromechanical conversion, electromagnetic conversion, and IR radiation. [Embodiment 60] The above electronics include one or more communication components that enable communication between the medical device and another device, whether implanted in the body or located outside the body, according to Embodiments 1 to 59. [Implementation clause 61] One or more of the above communication components are: Antenna, and A medical device according to embodiment 60, comprising a radio frequency (RF) transceiver coupled to the antenna and configured to transmit and receive RF signals. [Embodiment Clause 62] The one or more of the above communication components are: A transmitter configured and positioned to be coupled to an electrode associated with the above medical device and to be in contact with tissue, and The medical device according to embodiment 60, comprising a receiver configured and positioned to be coupled to an electrode associated with the above-mentioned medical device and to be in contact with tissue.

[0284] [Embodiment 63] One or more of the above communication components are: To enable capacitive coupling between the above medical device and the above other devices, or The medical device according to embodiment 60, configured to enable galvanic coupling between the above medical device and the above other device. [Embodiment Item 64] The above electronics include one or more sensors in the medical device according to embodiments 1 to 63. [Embodiment 65] The medical device according to Embodiment 64, wherein one or more of the sensors include an accelerometer configured to output a signal corresponding to the motion of the structure. [Implementation clause 66] The above-mentioned accelerometer is a medical device according to embodiment 65, comprising one of a one-dimensional accelerometer and a three-dimensional accelerometer. [Embodiment 67] The medical device according to Embodiment 65, wherein the electronics further include a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide one or more indicators of the patient's activity level, the integrity of the structure, and the movement of the structure relative to the implant site. [Embodiment 68] The medical device according to Embodiment 64, wherein one or more sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implant site. [Embodiment Item 69] The medical device according to Embodiment 64, wherein one or more of the sensors include a strain sensor configured to output a signal corresponding to motion, force, tension, velocity, or other mechanical force associated with the structure. [Embodiment Clause 70] The medical device according to Embodiment 69, wherein the electronics further include a processor coupled to the strain sensor to receive signals from the strain sensor over time and configured to process the signals to provide a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site. [Embodiment Clause 71] The medical device according to Embodiment 64, wherein one or more sensors include ultrasonic transducers configured to output a signal corresponding to ultrasonic energy detected within a region of the structure. [Embodiment 72] The medical device according to Embodiment 71, wherein the electronics further include a processor coupled to the ultrasonic transducer to receive a signal from the ultrasonic transducer and configured to process the signal to provide one or more of the following: characterization of a fracture site, characterization of tissue within the area of ​​the structure, and healing area glucose. [Embodiment Item 73] The medical device according to Embodiment 64, wherein the one or more sensors include one or more glucose detectors and oxygen sensors configured to output signals corresponding to either glucose level or oxygen level, respectively. [Embodiment Clause 74] The medical device according to embodiment 73, wherein the electronics further include a processor configured to receive the above signal, coupled to one or more of a glucose detector and an oxygen sensor, and to process the above signal to provide an indicator of inflammatory fluid within a region of the medical device. [Embodiment Item 75] The above-mentioned electronic cartridge further comprises a mechanism configured to deliver a catalytic material that causes a gaseous oxygen reaction at the implant site through a chemical reaction, as described in embodiments 1 to 74 of the medical device. [Embodiment Clause 76] The above mechanism is A reservoir that releases the above catalyst material at least once after implantation under the control of a sustained-release controller, and A medical device according to Embodiment 75, comprising one or more coatings of catalyst material applied to the electronic cartridge described above. [Embodiment Clause 77] It is a medical device, It has a sheath-like structure, a lumen extends through the sheath-like structure, and multiple electrodes are provided on the outer surface of the sheath-like structure, and the sheath-like structure is configured to be implanted in the body, at least partially. A medical device having an electronics cartridge containing electronics, wherein the electronics cartridge is inserted into the lumen and is configured to create one or more electrical connections between the electronics and the plurality of electrodes upon insertion. [Embodiment 78] The medical device according to embodiment 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a single set of electrodes spaced apart along the length of the shaft. [Embodiment Clause 79] The medical device according to embodiment 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a first set of electrodes spaced apart from each other along the length of a first side of the shaft, and a second set of electrodes spaced apart from each other along the length of a second side of the shaft spaced apart from the first side. [Embodiment 80] The medical device according to embodiment 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a first linear electrode provided on a first side of the shaft, and a second linear electrode provided on a second side of the shaft, spaced apart from the first side. [Embodiment 81] The above tubular structure is, A conductive body having an outer surface that is at least partially covered with an insulating material, The first electrode among the plurality of electrodes corresponding to the exposed portion of the conductive body, A medical device according to embodiment 77, further comprising a second electrode among the plurality of electrodes located on a portion of the insulating material. [Embodiment 82] The above electronics cartridge is A first electrical contact is positioned to contact the inner surface of the conductive body, thereby realizing an electrical coupling between the electronics and the first electrode. The medical device according to embodiment 81, further comprising a second electrical contact positioned to contact a portion of the second electrode, thereby realizing an electrical coupling between the electronics and the second electrode. [Embodiment 83] The medical device according to embodiment 82, wherein the electronic cartridge further comprises an insulating seal between the first electrical contact and the second electrical contact. [Embodiment 84] The medical device according to embodiment 82, wherein the second electrode is partially covered with an insulating material, and the portion of the second electrode that contacts the second electrical contact corresponds to the uncovered portion of the second electrode. [Embodiment 85] The medical device according to embodiment 84, wherein the uncoated portion of the second electrode is located within the head portion of the lumen, which is positioned at the proximal end of the sheath-like structure. [Embodiment 86] The above tubular structure is, It has a head and a body having an outer surface that is at least partially covered with insulating material, A first portion of the conductive material provided on the insulating material forms a first electrode among the plurality of electrodes, a first electrical contact located near the head, and a first conductive path between the first electrode and the first electrical contact. The medical device according to embodiment 77, wherein a second portion of the conductive material provided on the insulating material forms a second electrode among the plurality of electrodes, a second electrical contact located near the head, and a second conductive path between the second electrode and the second electrical contact. [Embodiment 87] The above electronics cartridge is A first electrical contact established to contact the first contact of the above-mentioned sheath-shaped structure, thereby realizing an electrical coupling between the electronics and the first electrode, and A medical device according to embodiment 86, having a second electrical contact established to contact the second contact of the sheath-like structure, thereby realizing an electrical coupling between the electronics and the second electrode. [Embodiment 88] The above tubular structure is, A distal component including the first electrode among the multiple electrodes described above, A medical device according to embodiment 77, further comprising a proximal component including a second electrode among the plurality of electrodes described above. [Embodiment Item 89] The medical device according to Embodiment 88, wherein each of the distal and proximal components has a conductive substrate having an outer surface at least partially covered with an insulating coating. [Embodiment Clause 90] The medical device according to Embodiment 88, wherein each of the distal and proximal components has mechanical features that enable mechanical coupling between the distal and proximal components. [Implementation item 91] The medical device according to embodiment 77, wherein the sheath-like structure and the electronics cartridge have mechanical features that allow the electronics cartridge to be securely fixed within the lumen. [Embodiment Clause 92] The medical device according to Embodiment 91, wherein the above mechanical features consist of one of the following: a difference in shape factor between the head of the electronics cartridge and the head portion of the lumen of the sheath-like structure; a projection associated with the electronics cartridge and a recess associated with the lumen of the sheath-like structure; and an interlock feature associated with the shaft of the electronics cartridge that receives the adhesive and the inner wall of the sheath-like structure that engages with the adhesive. [Embodiment Item 93] The medical device according to Embodiment 77, wherein the sheath-like structure and the electronics cartridge have mechanical features that allow the electronics cartridge to be removed from the lumen without damaging the structural integrity of either the electronics cartridge or the sheath-like structure. [Embodiment section 94] The above mechanical features are those of a complementary screw thread, as described in Embodiment 93 of the medical device.

[0285] [Embodiment Item 95] It is a medical device, It has a tubular structure, a lumen extending through the tubular structure, and at least one hole is provided through the side wall of the tubular structure, and the tubular structure is configured to be implanted at least partially inside the body. A medical device having a plurality of electrodes and an electronics cartridge containing electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to provide alignment between the plurality of electrodes and the at least one hole upon insertion. [Embodiment section 96] The above at least one hole corresponds to a slot, The medical device according to Embodiment 95, wherein the electronics cartridge has a shape factor that extends outward from the surface of the electronics cartridge and fits into the slot, and includes an electrode assembly that includes the plurality of electrodes. [Embodiment Clause 97] The medical device according to Embodiment 96, wherein the electrode assembly is biased with respect to the surface of the electronics cartridge so that the electronics cartridge can transition between a compressed state in which the outer surface of the electrode assembly is substantially coplanar with the surface of the electronics cartridge and an expanded state in which the outer surface of the electrode assembly is positioned above the surface of the electronics cartridge so as to penetrate the slot. [Embodiment Item 98] The above at least one hole corresponds to multiple holes, The above-mentioned electronic cartridge is a medical device according to embodiment 95, having a plurality of corresponding electrodes. [Embodiment Clause 99] The medical device according to embodiment 98, wherein the plurality of electrodes are ring electrodes recessed relative to the surface of the electronics cartridge, and as a result, when inserted into the lumen of the sheath-like structure, an annular space communicating with the hole is formed between the electrode surface and the inner wall of the sheath-like structure. [Implementation item 100] The above-mentioned plurality of electrodes include distal electrodes and proximal electrodes, as described in Embodiment 98 of the medical device. [Initiation clause 101] The above-mentioned plurality of electrodes include three or more electrodes arranged in an array between a distal electrode and a proximal electrode, as described in Embodiment 98 of the medical device. [Embodiment Item 102] It is a medical device, It has a sheath-like structure, the sheath-like structure having a lumen penetrating the sheath-like structure, as well as a distal end opening and a proximal end opening, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having an electronics cartridge containing multiple electrodes and electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to position a first electrode among the multiple electrodes at the distal end opening and a second electrode among the multiple electrodes at the proximal end opening during insertion. [Embodiment Item 103] The medical device according to embodiment 102, wherein the first electrode is a ring electrode recessed with respect to the surface of the electronics cartridge, and as a result, when inserted into the lumen, an annular space communicating with the distal end opening is formed between the surface of the first electrode and the inner wall of the sheath-like structure. [Embodiment Item 104] The medical device according to embodiment 102, wherein the sheath-like structure has a head with an outer periphery, and the second electrode extends from and beyond the electronic cartridge. [Embodiment Item 105] It is a medical device, It has a sheath-like structure, the sheath-like structure having a lumen penetrating the sheath-like structure, as well as a distal end opening and a proximal end opening, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having a plurality of electrodes and an electronics cartridge containing electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to position the plurality of electrodes distal to the distal end opening during insertion. [Embodiment Item 106] The above-mentioned electronic cartridge is a medical device according to embodiment 105, having a shaft having a length and at least two parts having different rigidities along the length. [Embodiment Item 107] The medical device according to embodiment 106, wherein the plurality of electrodes are associated with the less rigid portion of the at least two portions. [Embodiment 108] The above electronics are associated with the more rigid of the two above-mentioned parts, as described in Embodiment 106 of the medical device. [Embodiment Item 109] A medical device configured to be implanted at least partially inside the body, the medical device being: A structure having a head and a shaft, each having a head cavity and a shaft cavity, Electronics disposed in one or more of the head cavity and the shaft cavity, A medical device having at least one electrode associated with the shaft and electrically coupled to the electronics. [Initiation clause 110] The medical device according to embodiment 109, wherein the structure has a shaft, and the at least one electrode includes a single set of electrodes positioned spaced apart from each other along the length of the shaft. [Mention Section 111] The medical device according to embodiment 109, wherein the structure has a shaft, and the at least one electrode comprises a first pair of electrodes spaced apart from each other along the length of a first side of the shaft and a second pair of electrodes spaced apart from each other along the length of a second side of the shaft spaced apart from the first side. [Initiation Clause 112] The medical device according to embodiment 109, wherein the structure has a shaft, and the at least one electrode comprises a first linear electrode provided on a first side of the shaft, and a second linear electrode provided on a second side of the shaft, spaced apart from the first side. [Embodiment Item 113] The system further comprises sensors for measuring the electrical properties of the tissue, and the sensors are Multiple electrodes, A medical device according to embodiment 109, comprising a detection module coupled to the above-mentioned plurality of electrodes. [Embodiment Clause 114] The above-mentioned plurality of electrodes include a first electrode and a second electrode, The medical device according to Embodiment 113, wherein the detection module is configured to allow the first electrode and the second electrode to function in either an application mode in which a signal is applied to the entire electrode, or a detection mode in which the impedance between the electrodes is detected. [Implementation clause 115] The above-mentioned detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies, as described in Embodiment 114. [Implementation clause 116] The above sensor further includes an electrode switch, The plurality of electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode, which are switchably coupled to the detection module via the electrode switch. The medical device according to embodiment 113, wherein the detection module is configured to enable an application mode in which a signal is applied to the first electrode and the second electrode, and to enable a detection mode in which the impedance between the third electrode and the fourth electrode is detected. [Embodiment Clause 117] The above-mentioned detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies, as described in Embodiment 116. [Embodiment 118] The medical device according to Embodiment 113, wherein the electrical properties of the above-mentioned tissue include impedance measurements, and the medical device further comprises a controller configured to process the impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture. [Implementation clause 119] The above healing state corresponds to one of fusion, suspected nonunion, and nonunion, as described in Embodiment 118 of the medical device. [Embodiment Item 120] The above structure is a medical device according to embodiment 109, configured to be implanted in bone. [Initiation Clause 121] The above structure is configured to be implanted to bridge the fractured portion of the bone, as described in Embodiment 120. [Embodiment Section 122] The above structure is configured to be implanted through a hole provided in a plate that bridges the fractured portion of the bone, as described in Embodiment 120. [Embodiment Item 123] The above structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument, as described in Embodiment 109. [Embodiment Clause 124] The above structure is a medical device according to embodiment 109, having a shaft with an outer diameter in the range of 4 millimeters or more. [Embodiment Item 125] The medical device according to embodiment 109, wherein the structure has an outer surface and one or more electrodes provided on the outer surface and electrically coupled to the electronics.

[0286] [Embodiment Item 126] The medical device according to Embodiment 125, wherein the structure has a substrate, and one or more electrodes correspond to a conductive structure extending along the side wall of the substrate from the outer surface to the electronics. [Embodiment Clause 127] The medical device according to Embodiment 125, wherein the structure has a substrate, and one or more electrodes correspond to conductive structures that penetrate holes provided through the side walls of the substrate. [Embodiment 128] The medical device according to embodiment 127, wherein the conductive structure has a layer of conductive material extending from the outer surface of the structure to the inner surface of the structure along the side wall of the hole. [Embodiment Section 129] The above-mentioned conductive structure comprises a conductive pin that penetrates the above-mentioned hole, the medical device according to embodiment 127. [Embodiment Item 130] The medical device according to Embodiment 129, wherein the conductive pin is a pogo-type pin that is normally biased outward from the hole. [Embodiment Item 131] The above-mentioned conductive structure is comprised of a conductive material that fills the above-mentioned holes, as described in Embodiment 129 of the medical device. [Embodiment Item 132] The above substrate is made of a conductive material that is at least partially coated with an insulating material, the medical device according to Embodiment 129. [Embodiment Item 133] The above-mentioned hole has a side wall covered with an insulating material, as described in Embodiment 132 of the medical device. [Embodiment Item 134] The above substrate is made of a non-conductive material, as described in Embodiment 129 of the medical device. [Embodiment Item 135] The medical device according to Embodiment 125, wherein the structure has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end. [Embodiment Item 136] The medical device according to Embodiment 135, wherein one or more electrodes are electrically insulated from each other. [Embodiment Item 137] The above electronics include an antenna, as described in Embodiment 109 of the medical device. [Embodiment Item 138] The above antenna is related to the above shaft of the above structure, the medical device according to embodiment 137. [Embodiment Item 139] The above-mentioned antenna has a conductive wire or trace wire extending along the length of the above-mentioned shaft, the medical device according to embodiment 138. [Embodiment Item 140] The above-mentioned antenna extends in a spiral pattern around the above-mentioned shaft, the medical device according to embodiment 139. [Embodiment Clause 141] The above antenna is associated with the above head of the above structure, in the medical device according to embodiment 138. [Embodiment Clause 142] The medical device according to embodiment 141, wherein the antenna has a conductive wire or trace wire extending along a plane parallel to the base of the head. [Embodiment Item 143] The above electronics include one or more power sources, as described in Embodiment 109 of the medical device. [Embodiment Section 144] A medical device according to Embodiment 143, wherein one or more of the above-mentioned power sources are associated with the above-mentioned shaft of the above-mentioned structure. [Embodiment Item 145] The medical device according to Embodiment 143, wherein one or more of the above-mentioned power sources are associated with the head of the above-mentioned structure. [Embodiment Item 146] The medical device according to Embodiment 143, wherein the one or more power sources include one or more batteries and capacitors. [Embodiment Clause 147] The medical device according to Embodiment 143, wherein one or more of the above-mentioned power sources include an energy extraction device configured to extract energy by one of the following: electrostatic energy, wireless energy transfer, electromechanical conversion, electromagnetic conversion, and IR radiation. [Embodiment Item 148] The medical device according to Embodiment 109, wherein the electronics include one or more communication components that enable communication between the medical device and another device, whether implanted in the body or located outside the body. [Embodiment Clause 149] One or more of the above communication components are: Antenna, and A medical device according to Embodiment 148, comprising a radio frequency (RF) transceiver coupled to the above antenna and configured to transmit and receive RF signals. [Embodiment 150] The one or more of the above communication components are: A transmitter configured and positioned to be coupled to an electrode associated with the above medical device and to be in contact with tissue, and The medical device according to embodiment 148, comprising a receiver configured and positioned to be coupled to an electrode associated with the above-mentioned medical device and to be in contact with tissue. [Implementation Clause 151] One or more of the above communication components are: To enable capacitive coupling between the above medical device and the above other devices, or The medical device according to Embodiment 150, configured to enable galvanic coupling between the above medical device and the above other device. [Embodiment Item 152] The above electronics include one or more sensors in the medical device according to Embodiment 109. [Embodiment Item 153] The medical device according to Embodiment 152, wherein one or more of the sensors include an accelerometer configured to output a signal corresponding to the motion of the structure. [Embodiment Item 154] The above-mentioned accelerometer is a medical device according to embodiment 153, comprising one of a one-dimensional accelerometer and a three-dimensional accelerometer. [Embodiment Item 155] The medical device according to Embodiment 153, wherein the electronics further include a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide one or more indicators of the patient's activity level, the integrity of the structure, and the movement of the structure relative to the implant site. [Embodiment 156] The medical device according to Embodiment 152, wherein one or more of the sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implant site. [Embodiment Item 157] The medical device according to Embodiment 152, wherein one or more of the sensors include a strain sensor configured to output a signal corresponding to motion, force, tension, velocity, or other mechanical force associated with the structure. [Embodiment Item 158] The medical device according to Embodiment 157, wherein the electronics further include a processor coupled to the strain sensor to receive signals from the strain sensor over time and configured to process the signals to provide a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site. [Embodiment Item 159] The medical device according to Embodiment 152, wherein one or more sensors include ultrasonic transducers configured to output a signal corresponding to ultrasonic energy detected within a region of the structure. [Embodiment Item 160] The medical device according to Embodiment 159, wherein the electronics further include a processor coupled to the ultrasonic transducer to receive a signal from the ultrasonic transducer and configured to process the signal to provide one or more of the following: a fracture site, a tissue characterization within the area of ​​the structure, and glucose levels. [Implementation clause 161] The medical device according to Embodiment 152, wherein the one or more sensors include one or more glucose detectors and oxygen sensors configured to output signals corresponding to either glucose level or oxygen level, respectively. [Embodiment Clause 162] The medical device according to Embodiment 161, wherein the electronics further include a processor configured to receive the above signals, coupled to one or more of a glucose detector and an oxygen sensor, and to process the above signals to provide an indicator of inflammatory fluid within a region of the medical device. [Embodiment Item 163] The medical device according to embodiment 109, further comprising a mechanism configured to deliver a catalytic material that generates a gaseous oxygen reaction at the implant site through a chemical reaction. [Embodiment Clause 164] The above mechanism is A reservoir that releases the above catalyst material at least once after implantation under the control of a sustained-release controller, and A medical device according to Embodiment 163, comprising one or more coatings of catalyst material applied to the above structure. [Embodiment Item 165] It is a medical device, The sheath-like structure has a lumen extending through it, a plurality of holes provided through the side wall, and a plurality of electrodes, each associated with each of the plurality of holes, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having an electronics cartridge containing electronics, the electronics cartridge being at least partially provided within the lumen, and the electronics cartridge having a plurality of electrical contacts, each aligned with each of the holes to realize an electrical coupling between the electronics and each of the plurality of electrodes.

[0287] [Implementation clause 166] The above-mentioned sheath-shaped structure has a shaft, The above-mentioned multiple holes consist of a single set of holes that are spaced apart from each other along the length of the shaft. The medical device according to embodiment 165, wherein the plurality of electrodes described above consist of a single set of electrodes arranged at intervals from one another along the length of the shaft. [Embodiment Clause 167] The above-mentioned sheath-shaped structure has a shaft, The plurality of holes described above consist of a first set of holes spaced apart from each other along the length of the first side of the shaft, and a second set of holes spaced apart from the first side of the shaft along the length of the second side of the shaft. The medical device according to embodiment 165, wherein the plurality of electrodes consist of a first set of electrodes spaced apart from each other along the length of the first side of the shaft, and a second set of electrodes spaced apart from the first side of the shaft along the length of the second side of the shaft. [Embodiment 168] The above-mentioned sheath-shaped structure has a shaft, The aforementioned multiple holes consist of a first straight slot provided on the first side of the shaft, and a second straight slot provided on the second side of the shaft, which is located at a distance from the first side. The medical device according to embodiment 165, wherein the plurality of electrodes consist of a first linear electrode provided on the first side of the shaft and a second linear electrode provided on the second side of the shaft, which is spaced apart from the first side. [Embodiment Clause 169] The above-mentioned sheath-like structure has a substrate with an outer surface and an inner surface, The above multiple electrodes are, A first electrode provided on the outer surface and having a feedthrough that extends through a first hole among the plurality of holes to the inner surface of the substrate, A medical device according to embodiment 165, comprising a second electrode provided on the outer surface and having a feedthrough that extends through a second hole among the plurality of holes to the inner surface of the substrate. [Embodiment Clause 170] The above substrate is made of an insulating material, the medical device according to embodiment 169. [Embodiment Clause 171] The above substrate is a medical device according to embodiment 169, wherein the substrate is made of a conductive material coated with an insulating material. [Embodiment Clause 172] The above electronics cartridge is The first electrical contact among the plurality of electrical contacts is positioned to contact the feedthrough of the first electrode on the inner surface of the substrate, thereby realizing an electrical coupling between the electronics and the first electrode, A medical device according to embodiment 169, having a second electrical contact among a plurality of electrical contacts that contacts the feedthrough of the second electrode on the inner surface of the substrate, thereby positioning the electronics to achieve an electrical coupling with the second electrode. [Embodiment Item 173] The above multiple electrodes are, A first conductive structure that penetrates the first of the multiple holes mentioned above, The medical device according to embodiment 165, further comprising a second conductive structure that penetrates a second of the plurality of holes and extends to the inner surface of the main body. [Embodiment Clause 174] The medical device according to embodiment 173, wherein the first conductive structure corresponds to a first conductive pin, and the second conductive structure corresponds to a second conductive pin. [Embodiment Item 175] The medical device according to Embodiment 174, wherein each of the first conductive pin and the second conductive pin is a pogo-type pin that is normally biased outward from the first hole or the second hole. [Embodiment Item 176] The medical device according to embodiment 173, wherein each of the first conductive structure and the second conductive structure corresponds to a conductive material filling the first hole or the second hole. [Embodiment Clause 177] An implantable medical device that characterizes the site of a bone fracture, the above medical device is The implant has been configured to be implanted at least partially within the bone and across the fracture site, The implant includes an impedance sensor, and the impedance sensor is The first electrode and the second electrode, and The system includes a detection module configured to obtain impedance measurements between the first electrode and the second electrode, The implant has a memory-equipped controller that is provided within the implant and configured to process and store the impedance measurement values, A medical device having a communication circuit system provided within the implant and configured to transmit the impedance measurement values ​​to an external device. [Embodiment Item 178] The medical device according to Embodiment 177, wherein the detection module is configured to function in either an application mode in which the first electrode and the second electrode apply a signal to the entire electrode, or a detection mode in which the impedance between the first electrode and the second electrode is detected. [Embodiment Clause 179] The above-mentioned detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies, as described in Embodiment 178. [Embodiment 180] The impedance sensor described above further comprises a third electrode and a fourth electrode, The medical device according to Embodiment 177, wherein the detection module is configured to enable an application mode in which a signal is applied to the first electrode and the second electrode, and to enable a detection mode in which the impedance between the third electrode and the fourth electrode is detected. [Embodiment 181] The above-mentioned detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies, as described in Embodiment 180. [Embodiment 182] The controller is further configured to process impedance measurements over time to determine the characterization of the fracture site, the characterization of which corresponds to the healing state of the fracture site, according to Embodiment 177. [Embodiment Item 183] The above healing state corresponds to one of fusion, suspected nonunion, and nonunion, as described in Embodiment 182 of the medical device. [Embodiment 184] The medical device according to embodiment 177, wherein the first electrode and the second electrode are arranged on the implant at an interval from each other so as to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site. [Embodiment 185] The impedance sensor has a plurality of electrodes, including the first electrode, the second ele...

Claims

1. It is a medical device, A structure having a lumen that extends through at least partially and configured to be at least partially implanted in the body, A medical device comprising an electronics cartridge containing electronics and configured to be inserted into the lumen after implantation of the structure.

2. The system further comprises a sensor for measuring the electrical properties of tissue, and the sensor is Multiple electrodes, The medical device according to claim 1, comprising an electronics cartridge detection module, wherein the detection module is coupled to the plurality of electrodes.

3. The plurality of electrodes include a first electrode and a second electrode, The medical device according to claim 2, wherein the detection module is configured to function in either an application mode in which the first electrode and the second electrode apply a signal to the entire electrode, or a detection mode in which the impedance between the electrodes is detected.

4. The medical device according to claim 3, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

5. The sensor further includes an electrode switch, The plurality of electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode, which are switchably coupled to the detection module via the electrode switch. The medical device according to claim 2, wherein the detection module is configured to enable an application mode in which a signal is applied to the first electrode and the second electrode, and to enable a detection mode in which the impedance between the third electrode and the fourth electrode is detected.

6. The medical device according to claim 5, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

7. The medical device according to claim 2, wherein the electrical properties of the tissue include impedance measurements, and the medical device further comprises a controller configured to process impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture.

8. The medical device according to claim 7, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

9. The plurality of electrodes are associated with the structure and are spaced apart from each other so as to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site. The medical device according to claim 2, wherein the electronics cartridge has a plurality of electrical contacts arranged to electrically couple to the plurality of electrodes when the electronics cartridge is inserted into the lumen of the structure.

10. The medical device according to claim 2, wherein the plurality of electrodes are associated with the electronics cartridge and are spaced apart from each other to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site.

11. The structure has at least one hole penetrating the side wall, The medical device according to claim 10, wherein the plurality of electrodes are positioned on the electronics cartridge so as to align with the at least one hole when the electronics cartridge is inserted into the lumen of the structure.

12. The structure has a distal end opening and a proximal end opening, The medical device according to claim 10, wherein the plurality of electrodes include a first electrode positioned on the electronics cartridge so as to be adjacent to the distal end opening when the electronics cartridge is inserted into the lumen of the structure, and a second electrode positioned on the electronics cartridge so as to be adjacent to the proximal end opening.

13. The structure has a distal end opening, The medical device according to claim 10, wherein the plurality of electrodes include a first electrode and a second electrode positioned on the electronics cartridge such that when the electronics cartridge is inserted into the lumen of the structure, each electrode is positioned distal to the distal end opening of the structure.

14. The medical device according to claim 1, wherein the lumen is configured to receive an implantation tool during implantation of the structure.

15. The medical device according to claim 14, wherein the structure has a head having a recessed pocket that constitutes the head portion of the lumen, configured to receive a portion of the implant tool, thereby enabling the transmission of torque applied to the implant tool to the structure.

16. The medical device according to claim 1, wherein the structure is configured to be implanted in bone.

17. The medical device according to claim 16, wherein the structure is configured to be implanted to bridge the fractured portion of the bone.

18. The medical device according to claim 16, wherein the structure is configured to be implanted through a hole provided in a plate that bridges the fractured portion of the bone.

19. The medical device according to claim 1, wherein the structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

20. The medical device according to claim 1, wherein the structure has a shaft with an outer diameter of 4 millimeters or more.

21. The medical device according to claim 1, wherein the lumen has a shaft portion having a diameter sized to receive at least a portion of the electronics cartridge.

22. The medical device according to claim 1, wherein each of the electronic cartridge and the lumen has substantially identical shape factors.

23. The medical device according to claim 22, wherein the shape factor of the electronics cartridge and the lumen each includes a head portion and a shaft portion, and the head portion has a larger diameter than the shaft portion.

24. The medical device according to claim 1, wherein the structure and the electronics cartridge include mechanical features that allow the electronics cartridge to be securely fixed within the lumen.

25. The medical device according to claim 24, wherein the mechanical feature comprises one of the following: a difference in shape factor between the head of the electronics cartridge and the head portion of the lumen of the structure; a protrusion associated with the electronics cartridge and a recess associated with the lumen of the structure; and an interlock feature associated with the shaft of the electronics cartridge that receives the adhesive and the inner wall of the structure that engages with the adhesive.

26. The medical device according to claim 1, wherein the structure and the electronics cartridge have mechanical features that allow the electronics cartridge to be removed from the lumen without damaging the structural integrity of either the electronics cartridge or the structure.

27. The aforementioned mechanical feature is a complementary screw thread, as described in claim 26.

28. The medical device according to claim 1, wherein the electronics cartridge has a head and a shaft, and at least a portion of the electronics is contained in an electronics assembly disposed within the head.

29. The medical device according to claim 1, wherein the electronics cartridge has a head and a shaft, and at least a portion of the electronics is contained in an electronics assembly disposed within the shaft.

30. The structure has an outer surface, and one or more electrodes are located on the outer surface. The medical device according to claim 1, wherein the electronics cartridge has an outer surface and one or more electrical contacts provided on the outer surface that are configured to electrically couple to one or more electrodes when the electronics cartridge is inserted into the lumen.

31. The medical device according to claim 30, wherein the structure has a conductive substrate, one or more electrodes correspond to a conductive material associated with the sidewall of the conductive substrate, and one or more electrodes are electrically insulated from the conductive substrate by an insulating material.

32. The medical device according to claim 31, further comprising a feedthrough for one or more electrodes, the feedthrough extending through the side wall of the conductive substrate and providing an electrical connection between the one or more electrodes and the interior of the structure.

33. The structure has a conductive substrate that is at least partially covered with an insulating material, and one or more electrodes are The region of the conductive substrate that is not covered with the insulating material, and The medical device according to claim 30, which corresponds to one or more conductive materials located on the insulating material.

34. The medical device according to claim 30, wherein the structure has a substrate, and one or more electrodes correspond to a conductive material on the substrate.

35. The medical device according to claim 34, wherein the substrate is made of a non-conductive material.

36. The substrate is made of a conductive material. The medical device according to claim 34, wherein one or more electrodes correspond to conductive materials located on an insulating material.

37. The medical device according to claim 30, wherein the structure has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end.

38. The medical device according to claim 30, wherein one or more electrodes are electrically insulated from each other and from the structure.

39. The aforementioned structure has one or more holes penetrating the side wall, The medical device according to claim 1, wherein the electronic cartridge has one or more electrodes positioned to align with one or more holes when the electronic cartridge is inserted into the lumen of the structure.

40. The medical device according to claim 39, wherein each of the structure and the electronic cartridge is configured to align each of the one or more electrodes with a corresponding one of the one or more holes when the electronic cartridge is inserted into the lumen.

41. The medical device according to claim 39, wherein the electronic cartridge has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end.

42. The medical device according to claim 39, wherein one or more electrodes are electrically insulated from each other.

43. The one or more holes correspond to slots, The medical device according to claim 39, wherein the electronics cartridge has a shape factor that extends outward from the surface of the electronics cartridge and fits into the slot, and has an electrode assembly including one or more electrodes.

44. The medical device according to claim 43, wherein the electrode assembly is biased with respect to the surface of the electronics cartridge so that the electronics cartridge can transition between a compressed state in which the outer surface of the electrode assembly is substantially coplanar with the surface of the electronics cartridge and an expanded state in which the outer surface of the electrode assembly is positioned above the surface of the electronics cartridge so as to penetrate the slot.

45. The medical device according to claim 39, wherein the electrode is associated with the shaft of the electronics cartridge, and the electrode includes an electrode surface recessed with respect to the surface of the shaft such that when inserted into the lumen of the structure, an empty space communicating with a hole is formed between the electrode surface and the inner wall of the structure.

46. The structure has a distal end opening and a proximal end opening, The medical device according to claim 1, wherein the electronics cartridge has a first electrode positioned adjacent to the distal end opening and a second electrode positioned adjacent to the proximal end opening when the electronics cartridge is inserted into the lumen of the structure.

47. The structure has a distal end opening, The medical device according to claim 1, wherein the electronics cartridge has a plurality of electrodes positioned on the electronics cartridge so as to be located distal to the distal end opening when the electronics cartridge is inserted into the lumen of the structure.

48. The medical device according to claim 1, wherein the electronics include an antenna.

49. The electronics cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to claim 48, wherein the antenna is associated with the shaft.

50. The medical device according to claim 49, wherein the antenna has a conductive wire or trace wire extending along the length of the shaft.

51. The medical device according to claim 50, wherein the antenna extends in a spiral pattern around the shaft.

52. The medical device according to claim 51, wherein the antenna is electrically insulated from the outer surface of the shaft to avoid contact with the structure when the electronic cartridge is inserted into the lumen of the structure.

53. The electronics cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to claim 48, wherein the antenna is associated with the head.

54. The medical device according to claim 53, wherein the antenna has a conductive wire or trace wire extending along a plane parallel to the base of the head.

55. The medical device according to claim 1, wherein the electronics include one or more power sources.

56. The electronics cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to claim 55, wherein the one or more power sources are associated with the shaft.

57. The electronics cartridge has a proximal end, a distal end, a head provided at the proximal end, and a shaft extending from the head toward the distal end. The medical device according to claim 55, wherein the one or more power sources are associated with the head.

58. The medical device according to claim 55, wherein the one or more power sources include one or more batteries and capacitors.

59. The medical device according to claim 55, wherein the one or more power sources include an energy extraction device configured to extract energy by one of electrostatic energy, wireless energy transfer, electromechanical conversion, electromagnetic conversion, and IR radiation.

60. The medical device according to claim 1, wherein the electronics include one or more communication components that enable communication between the medical device and another device that is either implanted in the body or located outside the body.

61. The one or more communication components mentioned above are: Antenna, and The medical device according to claim 60, comprising a radio frequency (RF) transceiver coupled to the antenna and configured to transmit and receive RF signals.

62. The one or more communication components described above are: A transmitter configured and positioned to be coupled to an electrode associated with the medical device and to be in contact with tissue, and The medical device according to claim 60, comprising a receiver configured and positioned to be coupled to an electrode associated with the medical device and to be in contact with tissue.

63. The one or more communication components mentioned above are: To enable capacitive coupling between the aforementioned medical device and the aforementioned other devices, or The medical device according to claim 60, configured to enable galvanic coupling between the medical device and the other device.

64. The medical device according to claim 1, wherein the electronics include one or more sensors.

65. The medical device according to claim 64, wherein the one or more sensors include an accelerometer configured to output a signal corresponding to the motion of the structure.

66. The medical device according to claim 65, wherein the accelerometer comprises one of a one-dimensional accelerometer and a three-dimensional accelerometer.

67. The medical device according to claim 65, wherein the electronics further include a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide one or more indicators of the patient's activity level, the integrity of the structure, and the movement of the structure relative to the implant site.

68. The medical device according to claim 64, wherein the one or more sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implant site.

69. The medical device according to claim 64, wherein one or more sensors include strain sensors configured to output signals corresponding to motion, force, tension, velocity, or other mechanical forces associated with the structure.

70. The medical device according to claim 69, wherein the electronics further include a processor coupled to the strain sensor to receive signals from the strain sensor over time and configured to process the signals to provide a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site.

71. The medical device according to claim 64, wherein the one or more sensors include ultrasonic transducers configured to output a signal corresponding to ultrasonic energy detected within a region of the structure.

72. The medical device according to claim 71, further comprising a processor configured to receive a signal from the ultrasonic transducer and to process the signal to provide one or more of the following: a fracture site, a tissue within the area of ​​the structure, and a healing area glucose.

73. The medical device according to claim 64, wherein the one or more sensors include one or more glucose detectors and oxygen sensors configured to output signals corresponding to either glucose level or oxygen level, respectively.

74. The medical device according to claim 73, wherein the electronics further include a processor coupled to one or more glucose detectors and oxygen sensors to receive the signal and configured to process the signal to provide an indicator of inflammatory fluid within a region of the medical device.

75. The medical device according to claim 1, wherein the electronic cartridge further comprises a mechanism configured to deliver a catalytic material that causes a gaseous oxygen reaction at the implant site through a chemical reaction.

76. The aforementioned mechanism body is A reservoir that releases the catalyst material once or more after implantation under the control of a sustained-release controller, and The medical device according to claim 75, comprising one or more coatings of catalyst material applied to the electronics cartridge.

77. It is a medical device, It has a sheath-like structure, a lumen extends through the sheath-like structure, a plurality of electrodes are provided on the outer surface of the sheath-like structure, and the sheath-like structure is configured to be implanted in the body at least partially. A medical device having an electronics cartridge containing electronics, wherein the electronics cartridge is inserted into the lumen and is configured to realize one or more electrical connections between the electronics and the plurality of electrodes upon such insertion.

78. The medical device according to claim 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a single set of electrodes spaced apart along the length of the shaft.

79. The medical device according to claim 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a first set of electrodes spaced apart from each other along the length of a first side of the shaft, and a second set of electrodes spaced apart from each other along the length of a second side of the shaft spaced apart from the first side.

80. The medical device according to claim 77, wherein the sheath-like structure has a shaft, and the plurality of electrodes consist of a first linear electrode provided on a first side of the shaft, and a second linear electrode provided on a second side of the shaft, spaced apart from the first side.

81. The cannula-like structure is A conductive body having an outer surface that is at least partially covered with an insulating material, The first electrode among the plurality of electrodes corresponding to the exposed portion of the conductive body, The medical device according to claim 77, further comprising a second electrode among the plurality of electrodes located on a portion of the insulating material.

82. The aforementioned electronics cartridge is A first electrical contact is positioned to contact the inner surface of the conductive body, thereby realizing an electrical coupling between the electronics and the first electrode, The medical device according to claim 81, further comprising a second electrical contact positioned to contact a portion of the second electrode, thereby realizing an electrical coupling between the electronics and the second electrode.

83. The medical device according to claim 82, wherein the electronics cartridge further comprises an insulating seal between the first electrical contact and the second electrical contact.

84. The medical device according to claim 82, wherein the second electrode is partially covered with an insulating material, and the portion of the second electrode that contacts the second electrical contact corresponds to the uncovered portion of the second electrode.

85. The medical device according to claim 84, wherein the uncoated portion of the second electrode is located within the head portion of the lumen, which is positioned at the proximal end of the sheath-like structure.

86. The aforementioned sheath-shaped structure is It has a head and a body having an outer surface that is at least partially covered with insulating material, A first portion of the conductive material provided on the insulating material forms a first electrode among the plurality of electrodes, a first electrical contact located near the head, and a first conductive path between the first electrode and the first electrical contact. The medical device according to claim 77, wherein a second portion of the conductive material provided on the insulating material forms a second electrode among the plurality of electrodes, a second electrical contact located near the head, and a second conductive path between the second electrode and the second electrical contact.

87. The aforementioned electronics cartridge is A first electrical contact established to contact the first contact of the sheath-shaped structure, thereby realizing an electrical coupling between the electronics and the first electrode, and The medical device according to claim 86, further comprising a second electrical contact established to contact the second contact of the sheath-like structure, thereby realizing an electrical coupling between the electronics and the second electrode.

88. The cannula-like structure is A distal component including the first electrode among the plurality of electrodes, The medical device according to claim 77, comprising a proximal component including a second electrode among the plurality of electrodes.

89. The medical device according to claim 88, wherein each of the distal and proximal components has a conductive substrate having an outer surface at least partially covered with an insulating coating.

90. The medical device according to claim 88, wherein each of the distal component and the proximal component has mechanical features that enable mechanical coupling between the distal component and the proximal component.

91. The medical device according to claim 77, wherein the sheath-like structure and the electronics cartridge have mechanical features that allow the electronics cartridge to be securely fixed within the lumen.

92. The medical device according to claim 91, wherein the mechanical feature comprises one of the following: a difference in shape factor between the head of the electronics cartridge and the head portion of the lumen of the sheath-like structure; a protrusion associated with the electronics cartridge and a recess associated with the lumen of the sheath-like structure; and an interlock feature associated with the shaft of the electronics cartridge that receives the adhesive and the inner wall of the sheath-like structure that engages with the adhesive.

93. The medical device according to claim 77, wherein the sheath-like structure and the electronics cartridge have mechanical features that allow the electronics cartridge to be removed from the lumen without damaging the structural integrity of either the electronics cartridge or the sheath-like structure.

94. The aforementioned mechanical feature is a complementary screw thread, as described in claim 93.

95. It is a medical device, It has a tubular structure, a lumen extending through the tubular structure, and at least one hole is provided through the side wall of the tubular structure, and the tubular structure is configured to be implanted at least partially inside the body. A medical device having a plurality of electrodes and an electronics cartridge containing electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to provide alignment between the plurality of electrodes and the at least one hole upon insertion.

96. The at least one hole corresponds to a slot, The medical device according to claim 95, wherein the electronics cartridge has a shape factor that extends outward from the surface of the electronics cartridge and fits into the slot, and includes an electrode assembly that includes the plurality of electrodes.

97. The medical device according to claim 96, wherein the electrode assembly is biased with respect to the surface of the electronics cartridge so that the electronics cartridge can transition between a compressed state in which the outer surface of the electrode assembly is substantially coplanar with the surface of the electronics cartridge and an expanded state in which the outer surface of the electrode assembly is positioned above the surface of the electronics cartridge so as to penetrate the slot.

98. The at least one hole corresponds to a plurality of holes, The medical device according to claim 95, wherein the electronic cartridge has a plurality of corresponding electrodes.

99. The medical device according to claim 98, wherein the plurality of electrodes are ring electrodes recessed with respect to the surface of the electronics cartridge, and as a result, when inserted into the lumen of the sheath-like structure, an annular space communicating with the hole is formed between the electrode surface and the inner wall of the sheath-like structure.

100. The medical device according to claim 98, wherein the plurality of electrodes include a distal electrode and a proximal electrode.

101. The medical device according to claim 98, wherein the plurality of electrodes include three or more electrodes arranged in an array between a distal electrode and a proximal electrode.

102. It is a medical device, It has a sheath-like structure, the sheath-like structure having a lumen penetrating the sheath-like structure, as well as a distal end opening and a proximal end opening, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having an electronics cartridge containing a plurality of electrodes and electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to position a first electrode among the plurality of electrodes at the distal end opening and a second electrode among the plurality of electrodes at the proximal end opening during insertion.

103. The medical device according to claim 102, wherein the first electrode is a ring electrode recessed with respect to the surface of the electronics cartridge, and as a result, when inserted into the lumen, an annular space communicating with the distal end opening is formed between the surface of the first electrode and the inner wall of the sheath-like structure.

104. The medical device according to claim 102, wherein the sheath-like structure has a head with an outer periphery, and the second electrode extends from and beyond the electronics cartridge.

105. It is a medical device, It has a sheath-like structure, the sheath-like structure having a lumen penetrating the sheath-like structure, as well as a distal end opening and a proximal end opening, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having a plurality of electrodes and an electronics cartridge containing electronics electrically coupled to the electrodes, wherein the electronics cartridge is inserted into the lumen and is configured to position the plurality of electrodes distal to the distal end opening during such insertion.

106. The medical device according to claim 105, wherein the electronic cartridge has a shaft having a length, and at least two parts having different rigidities along the length.

107. The medical device according to claim 106, wherein the plurality of electrodes are associated with the less rigid portion of the at least two portions.

108. The medical device according to claim 106, wherein the electronics are associated with the more rigid of the at least two parts.

109. A medical device configured to be implanted at least partially inside the body, wherein the medical device is A structure having a head and a shaft, each having a head cavity and a shaft cavity, Electronics disposed in one or more of the head cavity and the shaft cavity, A medical device having at least one electrode associated with the shaft and electrically coupled to the electronics.

110. The medical device according to claim 109, wherein the structure has a shaft, and the at least one electrode includes a single set of electrodes spaced apart from each other along the length of the shaft.

111. The medical device according to claim 109, wherein the structure has a shaft, and the at least one electrode comprises a first pair of electrodes spaced apart from each other along the length of a first side of the shaft and a second pair of electrodes spaced apart from each other along the length of a second side of the shaft spaced apart from the first side.

112. The medical device according to claim 109, wherein the structure has a shaft, and the at least one electrode comprises a first linear electrode provided on a first side of the shaft, and a second linear electrode provided on a second side of the shaft located at a distance from the first side.

113. The system further comprises sensors for measuring the electrical properties of tissue, and the sensors are Multiple electrodes, The medical device according to claim 109, comprising a detection module coupled to the plurality of electrodes.

114. The plurality of electrodes include a first electrode and a second electrode, The medical device according to claim 113, wherein the detection module is configured to allow the first electrode and the second electrode to function in either an application mode in which a signal is applied to the entire electrode, or a detection mode in which the impedance between the electrodes is detected.

115. The medical device according to claim 114, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

116. The sensor further includes an electrode switch, The plurality of electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode, which are switchably coupled to the detection module via the electrode switch. The medical device according to claim 113, wherein the detection module is configured to perform an application mode in which a signal is applied to the first electrode and the second electrode, and to perform a detection mode in which the impedance between the third electrode and the fourth electrode is detected.

117. The medical device according to claim 116, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

118. The medical device according to claim 113, wherein the electrical properties of the tissue include impedance measurements, and the medical device further comprises a controller configured to process impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture.

119. The medical device according to claim 118, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

120. The medical device according to claim 109, wherein the structure is configured to be implanted in bone.

121. The medical device according to claim 120, wherein the structure is configured to be implanted to bridge the fractured portion of the bone.

122. The medical device according to claim 120, wherein the structure is configured to be implanted through a hole provided in a plate that bridges the fractured portion of the bone.

123. The medical device according to claim 109, wherein the structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

124. The medical device according to claim 109, wherein the structure has a shaft with an outer diameter of 4 millimeters or more.

125. The medical device according to claim 109, wherein the structure has an outer surface and one or more electrodes provided on the outer surface that are electrically coupled to the electronics.

126. The medical device according to claim 125, wherein the structure has a substrate, and one or more electrodes correspond to a conductive structure extending along the side wall of the substrate from the outer surface to the electronics.

127. The medical device according to claim 125, wherein the structure has a substrate, and one or more electrodes correspond to conductive structures that penetrate holes provided through the side walls of the substrate.

128. The medical device according to claim 127, wherein the conductive structure has a layer of conductive material extending from the outer surface of the structure along the side wall of the hole to the inner surface of the structure.

129. The medical device according to claim 127, wherein the conductive structure comprises a conductive pin that penetrates the hole.

130. The medical device according to claim 129, wherein the conductive pin is a pogo-type pin that is normally biased outward from the hole.

131. The medical device according to claim 129, wherein the conductive structure is made of a conductive material that fills the holes.

132. The medical device according to claim 129, wherein the substrate is made of a conductive material that is at least partially coated with an insulating material.

133. The medical device according to claim 132, wherein the hole has a side wall covered with an insulating material.

134. The medical device according to claim 129, wherein the substrate is made of a non-conductive material.

135. The medical device according to claim 125, wherein the structure has a proximal end and a distal end, and the one or more electrodes consist of one or more of the following: a distal electrode located near the distal end, a proximal electrode located near the proximal end, a plurality of distal electrodes located near the distal end, a plurality of proximal electrodes located near the proximal end, and a plurality of electrodes located between the proximal end and the distal end.

136. The medical device according to claim 135, wherein one or more electrodes are electrically insulated from each other.

137. The medical device according to claim 109, wherein the electronics include an antenna.

138. The medical device according to claim 137, wherein the antenna is associated with the shaft of the structure.

139. The medical device according to claim 138, wherein the antenna has a conductive wire or trace wire extending along the length of the shaft.

140. The medical device according to claim 139, wherein the antenna extends in a spiral pattern around the shaft.

141. The medical device according to claim 138, wherein the antenna is associated with the head of the structure.

142. The medical device according to claim 141, wherein the antenna has a conductive wire or trace wire extending along a plane parallel to the base of the head.

143. The medical device according to claim 109, wherein the electronics include one or more power sources.

144. The medical device according to claim 143, wherein the one or more power sources are associated with the shaft of the structure.

145. The medical device according to claim 143, wherein the one or more power sources are associated with the head of the structure.

146. The medical device according to claim 143, wherein the one or more power sources include one or more batteries and capacitors.

147. The medical device according to claim 143, wherein the one or more power sources include an energy extraction device configured to extract energy by one of electrostatic energy, wireless energy transfer, electromechanical conversion, electromagnetic conversion, and IR radiation.

148. The medical device according to claim 109, wherein the electronics include one or more communication components that enable communication between the medical device and another device, whether implanted in the body or located outside the body.

149. The one or more communication components mentioned above are: Antenna, and The medical device according to claim 148, comprising a radio frequency (RF) transceiver coupled to the antenna and configured to transmit and receive RF signals.

150. The one or more communication components described above are: A transmitter configured and positioned to be coupled to an electrode associated with the medical device and to be in contact with tissue, and The medical device according to claim 148, comprising a receiver configured and positioned to be coupled to an electrode associated with the medical device and to be in contact with tissue.

151. The one or more communication components mentioned above are: To enable capacitive coupling between the aforementioned medical device and the aforementioned other devices, or The medical device according to claim 150, configured to enable galvanic coupling between the medical device and the other device.

152. The medical device according to claim 109, wherein the electronics include one or more sensors.

153. The medical device according to claim 152, wherein the one or more sensors include an accelerometer configured to output a signal corresponding to the motion of the structure.

154. The medical device according to claim 153, wherein the accelerometer comprises one of a one-dimensional accelerometer and a three-dimensional accelerometer.

155. The medical device according to claim 153, wherein the electronics further include a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide one or more indicators of the patient's activity level, the integrity of the structure, and the movement of the structure relative to the implant site.

156. The medical device according to claim 152, wherein the one or more sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implant site.

157. The medical device according to claim 152, wherein one or more sensors include strain sensors configured to output signals corresponding to motion, force, tension, velocity, or other mechanical forces associated with the structure.

158. The medical device according to claim 157, wherein the electronics further include a processor coupled to the strain sensor to receive a signal from the strain sensor over time and configured to process the signal to provide a characterization of the fracture site, the characterization corresponding to the healing state of the fracture site.

159. The medical device according to claim 152, wherein the one or more sensors include ultrasonic transducers configured to output a signal corresponding to ultrasonic energy detected within a region of the structure.

160. The medical device according to claim 159, wherein the electronics further include a processor coupled to the ultrasonic transducer to receive a signal from the ultrasonic transducer and configured to process the signal to provide one or more of the following: a fracture site, a tissue characterization within the area of ​​the structure, and glucose levels.

161. The medical device according to claim 152, wherein the one or more sensors include one or more glucose detectors and oxygen sensors configured to output signals corresponding to either glucose level or oxygen level, respectively.

162. The medical device according to claim 161, wherein the electronics further include a processor configured to receive the signal, and to process the signal to provide an indicator of inflammatory fluid within a region of the medical device.

163. The medical device according to claim 109, further comprising a mechanism configured to deliver a catalytic material that generates a gaseous oxygen reaction at the implant site through a chemical reaction.

164. The aforementioned mechanism body is A reservoir that releases the catalyst material once or more after implantation under the control of a sustained-release controller, and The medical device according to claim 163, comprising one or more coatings of catalyst material applied to the aforementioned structure.

165. It is a medical device, The sheath-like structure has a lumen extending through it, a plurality of holes provided through the side wall, and a plurality of electrodes, each associated with each of the plurality of holes, and the sheath-like structure is configured to be implanted at least partially inside the body. A medical device having an electronics cartridge containing electronics, the electronics cartridge being at least partially provided within the lumen, and the electronics cartridge having a plurality of electrical contacts, each aligned with each of the holes to realize an electrical coupling between the electronics and each of the plurality of electrodes.

166. The aforementioned sheath-shaped structure has a shaft, The plurality of holes consist of a single set of holes that are spaced apart from each other along the length of the shaft. The medical device according to claim 165, wherein the plurality of electrodes consist of a single set of electrodes arranged at intervals from one another along the length of the shaft.

167. The aforementioned sheath-shaped structure has a shaft, The plurality of holes consist of a first set of holes spaced apart from each other along the length of the first side of the shaft, and a second set of holes spaced apart from the first side of the shaft along the length of the second side of the shaft. The medical device according to claim 165, wherein the plurality of electrodes consist of a first set of electrodes arranged at intervals from one another along the length of the first side of the shaft, and a second set of electrodes arranged at intervals along the length of the second side of the shaft, which is located at an interval from the first side.

168. The aforementioned sheath-shaped structure has a shaft, The plurality of holes consist of a first straight slot provided on the first side of the shaft, and a second straight slot provided on the second side of the shaft, which is spaced apart from the first side. The medical device according to claim 165, wherein the plurality of electrodes consist of a first linear electrode provided on the first side of the shaft and a second linear electrode provided on the second side of the shaft, which is located at a distance from the first side.

169. The sheath-shaped structure has a substrate with an outer surface and an inner surface, The aforementioned plurality of electrodes are A first electrode provided on the outer surface and having a feedthrough that extends through a first hole among the plurality of holes to the inner surface of the substrate, The medical device according to claim 165, further comprising: a second electrode provided on the outer surface and having a feedthrough that extends through a second hole among the plurality of holes to the inner surface of the substrate.

170. The medical device according to claim 169, wherein the substrate is made of an insulating material.

171. The medical device according to claim 169, wherein the substrate consists of a conductive material covered with an insulating material.

172. The aforementioned electronics cartridge is The first electrical contact among the plurality of electrical contacts is positioned to contact the feedthrough of the first electrode on the inner surface of the substrate, thereby enabling an electrical coupling between the electronics and the first electrode, The medical device according to claim 169, further comprising a second electrical contact among a plurality of electrical contacts that contacts the feedthrough of the second electrode on the inner surface of the substrate, thereby positioning the electronics to achieve an electrical coupling with the second electrode.

173. The aforementioned plurality of electrodes are A first conductive structure that penetrates the first hole among the plurality of holes, The medical device according to claim 165, further comprising a second conductive structure that penetrates a second hole among the plurality of holes and extends to the inner surface of the main body.

174. The medical device according to claim 173, wherein the first conductive structure corresponds to a first conductive pin, and the second conductive structure corresponds to a second conductive pin.

175. The medical device according to claim 174, wherein each of the first conductive pin and the second conductive pin is a pogo-type pin that is normally biased outward from the first hole or the second hole.

176. The medical device according to claim 173, wherein each of the first conductive structure and the second conductive structure corresponds to a conductive material filling the first hole or the second hole.

177. An implantable medical device that characterizes a bone fracture site, wherein the medical device is The implant is configured to be implanted in the bone and at least partially across the fracture site, The implant includes an impedance sensor, and the impedance sensor is A first electrode and a second electrode, and The system includes a detection module configured to obtain impedance measurements between the first electrode and the second electrode, The implant has a memory-equipped controller provided within it, which is configured to process and store the impedance measurement values. A medical device having a communication circuit system provided within the implant and configured to transmit the impedance measurement value to an external device.

178. The medical device according to claim 177, wherein the detection module is configured to function in either an application mode in which the first electrode and the second electrode apply a signal to the entire electrode, or a detection mode in which the impedance between the first electrode and the second electrode is detected.

179. The medical device according to claim 178, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

180. The impedance sensor further comprises a third electrode and a fourth electrode, The medical device according to claim 177, wherein the detection module is configured to enable an application mode in which a signal is applied to the first electrode and the second electrode, and to enable a detection mode in which the impedance between the third electrode and the fourth electrode is detected.

181. The medical device according to claim 180, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

182. The controller is further configured to process impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture site, according to claim 177.

183. The medical device according to claim 182, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

184. The medical device according to claim 177, wherein the first electrode and the second electrode are spaced apart on the implant so as to allow the placement of the first electrode and the second electrode on opposite sides of the fracture site.

185. The medical device according to claim 177, wherein the impedance sensor has a plurality of electrodes, including a first electrode, a second electrode, and at least one additional electrode, and the detection module is configured to select the first electrode and the second electrode from the plurality of electrodes based on impedance measurements such that the first electrode and the second electrode are located opposite each other from the fracture site.

186. The medical device according to claim 177, wherein the communication circuit system comprises a tissue-conductive communication circuit system that is coupled to the first electrode and the second electrode and is configured to enable capacitive coupling between the medical device and another device, or to enable galvanic coupling between the medical device and the other device.

187. The aforementioned implant is The lumen has a structure that extends through it at least partially, and the structure is configured to be implanted at least partially within the bone and across the fracture site, The medical device according to claim 177, comprising an electronics cartridge including at least a portion of the impedance sensor, the controller, the memory, and at least a portion of the communication circuit system, wherein the electronics cartridge is configured to be inserted into the lumen after implantation of the structure.

188. The medical device according to claim 187, wherein the structure has an outer surface, and the first electrode and the second electrode are located on the outer surface.

189. The structure has at least one hole penetrating the side wall, The medical device according to claim 187, wherein the electronics cartridge has an outer surface, the first electrode and the second electrode are located on the outer surface and are positioned to align with the at least one hole when the electronics cartridge is inserted into the lumen of the structure.

190. The medical device according to claim 187, wherein the structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

191. The implant comprises a single structure, as described in claim 177.

192. The medical device according to claim 191, wherein the single structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

193. A method for characterizing the fracture site, wherein the method is The step includes obtaining multiple measurements of the electrical properties of the bone tissue over time via a plurality of electrodes positioned within the bone tissue and across the fracture site, wherein the plurality of electrodes include a first electrode and a second electrode located on opposite sides of the fracture site. A method comprising the step of processing the measured quantity to determine the characterization of the fracture site, wherein the characterization corresponds to the healing state of the fracture site.

194. The method according to claim 193, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

195. The method according to claim 193, further comprising the step of communicating the plurality of measurements of the electrical properties of the tissue or the characterization of the fracture site to an external device.

196. The electrical properties of the said tissue include impedance, and the step of obtaining the plurality of measured quantities is, The method according to claim 193, comprising the step of applying signals to the first electrode at different frequencies and measuring tissue impedance according to electrical impedance spectroscopy (EIS).

197. The method according to claim 196, wherein the signal is applied by an implanted detection module.

198. The method according to claim 193, further comprising the step of implanting the plurality of electrodes such that the first electrode and the second electrode are positioned opposite each other from the fracture site.

199. The step of implanting the plurality of electrodes is, The procedure includes the step of implanting at least one tubular structure in the bone tissue across the fracture site, wherein the tubular structure has a lumen extending at least partially through the tubular structure. The method according to claim 198, comprising the step of inserting an electronics cartridge into the lumen after implanting the sheath-like structure, wherein the electronics cartridge includes a detection module.

200. The method according to claim 199, wherein the plurality of electrodes are supported by the sheath-like structure and coupled to the detection module when the electronic cartridge is inserted into the lumen.

201. The method according to claim 199, wherein the plurality of electrodes are supported by the electronics cartridge and interface with bone tissue through a plurality of holes provided in the side wall of the sheath-like structure.

202. The method according to claim 199, further comprising the step of fixing the electronics cartridge to the sheath-like structure.

203. The step of implanting the plurality of electrodes is, The method according to claim 198, comprising the step of implanting a structure supporting the plurality of electrodes and a medical device having electronics arranged within the structure and coupled to the plurality of electrodes.

204. A method for characterizing the fracture site, wherein the method is The step includes obtaining multiple measurements of the electrical properties of the tissue over time via a plurality of electrodes placed within the bone tissue, wherein the plurality of electrodes include a first electrode and a second electrode, each located within the gap of the fracture. A method comprising the step of processing the measured quantity to determine the characterization of the fracture site, wherein the characterization corresponds to the healing state of the fracture site.

205. The method according to claim 204, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

206. The method according to claim 204, further comprising transmitting the plurality of measurements of the electrical properties of the tissue, or the characterization of bone destruction, to an external device.

207. The electrical properties of the said tissue include impedance, and the step of obtaining the plurality of measured quantities is, The method according to claim 204, comprising the step of applying signals to the first electrode at different frequencies and measuring tissue impedance according to electrical impedance spectroscopy (EIS).

208. The method according to claim 207, wherein the signal is applied by an implanted detection module.

209. The method according to claim 204, further comprising the step of implanting the plurality of electrodes such that the first electrode and the second electrode are positioned within the gap in the fractured portion.

210. The step of implanting the plurality of electrodes is, The procedure includes the step of implanting at least one tubular structure in the bone tissue and across the gap in the fracture, wherein the tubular structure has a lumen extending at least partially through the tubular structure, The method according to claim 209, comprising the step of inserting an electronics cartridge into the lumen after implanting the sheath-like structure, wherein the electronics cartridge includes a detection module.

211. The method according to claim 210, wherein the plurality of electrodes are supported by the sheath-like structure and coupled to the detection module when the electronics cartridge is inserted into the lumen.

212. The method according to claim 210, wherein the plurality of electrodes are supported by the electronics cartridge and interface with bone tissue through a plurality of holes provided in the side wall of the sheath-like structure.

213. The method according to claim 210, further comprising the step of fixing the electronics cartridge to the sheath-like structure.

214. The step of implanting the plurality of electrodes is, The method according to claim 209, comprising the step of implanting a structure supporting the plurality of electrodes and a medical device having electronics arranged within the structure and coupled to the plurality of electrodes.

215. A method for characterizing a fracture site, wherein the method is The step includes obtaining multiple measurements of the electrical properties of the tissue over time via a plurality of electrodes placed within the bone tissue, wherein the plurality of electrodes each include a first electrode and a second electrode that straddle the gap in the fracture site. A method comprising the step of processing the measured quantity to determine the characterization of the fracture site, wherein the characterization corresponds to the healing state of the fracture site.

216. The method according to claim 215, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

217. The method according to claim 215, further comprising transmitting the plurality of measurements of the electrical properties of the tissue, or the characterization of bone destruction, to an external device.

218. The electrical properties of the said tissue include impedance, and the step of obtaining the plurality of measured quantities is, The method according to claim 215, comprising the step of applying signals to the first electrode at different frequencies and measuring tissue impedance according to electrical impedance spectroscopy (EIS).

219. The method according to claim 218, wherein the signal is applied by an implanted detection module.

220. The method according to claim 215, further comprising the step of implanting the plurality of electrodes such that the first electrode and the second electrode straddle the gap in the fractured portion.

221. The step of implanting the plurality of electrodes is, The procedure includes the step of implanting at least one tubular structure in the bone tissue and across the gap in the fracture, wherein the tubular structure has a lumen extending at least partially through the tubular structure, The method according to claim 220, comprising the step of inserting an electronics cartridge into the lumen after implanting the sheath-like structure, wherein the electronics cartridge includes a detection module.

222. The method according to claim 221, wherein the plurality of electrodes are supported by the sheath-like structure and coupled to the detection module when the electronic cartridge is inserted into the lumen.

223. The method according to claim 221, wherein the plurality of electrodes are supported by the electronics cartridge and interface with bone tissue through a plurality of holes provided in the side wall of the sheath-like structure.

224. The method according to claim 221, further comprising the step of fixing the electronics cartridge to the sheath-like structure.

225. The step of implanting the plurality of electrodes is, The method according to claim 220, comprising the step of implanting a structure supporting the plurality of electrodes and a medical device having electronics arranged within the structure and coupled to the plurality of electrodes.

226. An implantable medical device that characterizes a bone fracture site, wherein the medical device is The first implant is configured to be at least partially implanted in the bone, and the first implant has a first electrode. The device has a second implant configured to be at least partially implanted in the bone, the second implant having a second electrode, The third implant is positioned on the bone, crossing the fracture site, and is configured to be fixed in place by the first and second implants. It has an impedance sensor, and the impedance sensor is The first electrode and the second electrode, and It comprises a detection module provided in one of the first, second, or third implants, and configured to obtain impedance measurements between the first electrode and the second electrode, A controller with memory is provided in one of the first, second, or third implants and is configured to process and store the impedance measurement values. A medical device having a communication circuit system provided in one of the first, second, or third implants, and configured to transmit the impedance measurement value to an external device.

227. The medical device according to claim 226, wherein the third implant is configured to enable the connection of the first implant and the second implant at their respective placement locations along the third implant, where the first electrode and the second electrode are positioned opposite each other from the fracture site.

228. The medical device according to claim 226, wherein the detection module is configured to allow the first electrode and the second electrode to function in either an application mode in which a signal is applied to the entire electrode, or a detection mode in which the impedance between the first electrode and the second electrode is detected.

229. The medical device according to claim 228, wherein the detection module includes a signal generator configured to measure tissue impedance according to electrical impedance spectroscopy (EIS) by applying signals at different frequencies.

230. The controller is further configured to process impedance measurements over time to determine the characterization of the fracture site, the characterization corresponding to the healing state of the fracture site, according to claim 226.

231. The medical device according to claim 230, wherein the healing state corresponds to one of fusion, suspected nonunion, and nonunion.

232. The medical device according to claim 226, wherein the communication circuit system comprises a tissue-conductive communication circuit system that is coupled to the first electrode and the second electrode and is configured to enable capacitive coupling between the medical device and another device, or to enable galvanic coupling between the medical device and the other device.

233. At least one of the first implant and the second implant is The lumen has a structure that extends through it at least partially, and the structure is configured to be implanted at least partially within the bone and across the fracture site, The medical device according to claim 226, comprising an electronics cartridge including at least a portion of the impedance sensor, the controller, the memory, and at least a portion of the communication circuit system, wherein the electronics cartridge is configured to be inserted into the lumen after implantation of the structure.

234. The medical device according to claim 233, wherein the structure has an outer surface, and the first electrode and the second electrode are located on the outer surface.

235. The structure has at least one hole penetrating the side wall, The medical device according to claim 233, wherein the electronics cartridge has an outer surface, and the first electrode or the second electrode is located on the outer surface and is positioned to align with the at least one hole when the electronics cartridge is inserted into the lumen of the structure.

236. The medical device according to claim 233, wherein the structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

237. The medical device according to claim 228, wherein at least one of the first implant and the second implant comprises a single structure.

238. The medical device according to claim 237, wherein the single structure is a screw, pin, rod, nail, part of a joint replacement implant, part of a spinal fixation device, or part of another orthopedic instrument.

239. A method for manufacturing an implantable medical device, wherein the method is The steps include creating multiple holes by penetrating the side wall of a sheath-like structure that is configured to be implanted at least partially inside the body and has a lumen extending through it, The steps of associating the electrode with each of the plurality of holes, A method comprising the steps of associating an electronics cartridge with the lumen of the sheath-like structure, wherein the electronics cartridge comprises electronics and a plurality of electrical contacts, and the association aligns each of the plurality of electrical contacts with each of the holes to realize an electrical coupling between the electronics and each electrode.

240. The sheath-shaped structure is made of a conductive material, and the step of associating electrodes with each of the plurality of holes is, The steps include: applying an insulating material to the sheath-shaped structure within one area of ​​each of the plurality of holes; The method according to claim 239, comprising the step of covering and adhering the insulating material with a conductive material within one area of ​​each of the plurality of holes.

241. The sheath-shaped structure is made of an insulating material, and the step of associating the electrodes with each of the plurality of holes is, The method according to claim 239, comprising the step of covering and adhering a conductive material to a plurality of surfaces of the sheath-like structure within one area of ​​each of the plurality of holes.

242. The sheath-shaped structure is made of a conductive material, and the step of associating electrodes with each of the plurality of holes is, The steps include: applying an insulating material to the sheath-shaped structure within one area of ​​each of the plurality of holes; The method according to claim 239, comprising the step of arranging a conductive structure through each of the plurality of holes.

243. The method according to claim 242, wherein the step of arranging the conductive structure includes the step of inserting conductive pins through each of the plurality of holes.

244. The method according to claim 242, wherein the step of arranging the conductive structure includes the step of filling each of the plurality of holes with a conductive material.

245. The sheath-shaped structure is made of an insulating material, and the step of associating the electrodes with each of the plurality of holes is, The steps of inserting a conductive pin through each of the plurality of holes, The method according to claim 239, comprising at least one of the steps of filling each of the plurality of holes with a conductive material.

246. A method for implanting a medical device, wherein the method is The procedure includes the step of implanting an implant structure into the body at least partially, wherein the implant structure has a lumen that extends at least partially through the implant structure. A method comprising the step of inserting an electronics cartridge into the lumen after implanting the implant structure.

247. The implant structure has a proximal end with a head and a shaft extending from the head to the distal end of the implant structure, and the step of implanting the implant structure is, The steps include inserting the support structure into the shaft and at least partially along the length of the lumen, The method according to claim 246, further comprising the step of rotating the support structure together with the implant structure.

248. The method according to claim 247, wherein the step of rotating the support structure together with the implant structure includes the step of transmitting rotational torque from the support structure to a portion of the shaft.

249. The method according to claim 248, wherein the shaft and the support structure are configured to be mechanically coupled to each other so as to enable the direct transmission of rotational torque to the shaft.

250. The method according to claim 247, further comprising the step of positioning the implant structure along a guide wire positioned across the fracture site before inserting the support structure.

251. The implant structure has a proximal end with a head and a shaft extending from the head to the distal end of the implant structure, and the step of implanting the implant structure is, The steps include: placing the implant structure within a connecting device having a main body configured to achieve mechanical connection with the distal end portion of the implant structure; The method according to claim 246, further comprising the step of rotating the coupling device together with the implant structure.

252. The method according to claim 251, wherein the step of rotating the coupling device together with the implant structure includes the step of transmitting rotational torque along the length of the body to the mechanical coupling and to the distal end portion of the implant structure.

253. The method according to claim 252, wherein the connecting device is connected to the implant structure only at the distal end portion of the implant structure.

254. The method according to claim 246, further comprising the step of fixing the electronics cartridge to the implant structure.

255. The method according to claim 254, further comprising the step of removing the electronic cartridge from the lumen without affecting the structural integrity of the implant structure or the electronic cartridge, after the electronic cartridge has been fixed to the implant structure.

256. The method according to claim 255, further comprising the step of removing the electronics cartridge from the lumen and then inserting a replacement electronics cartridge into the lumen of the implant structure.

257. A tool for implanting an implant structure, wherein the implant structure has a proximal end with a head, a shaft extending from the head to the distal end of the implant structure, and a lumen extending through the shaft, the tool is Drill bit and It has a mechanism for applying rotational torque to the drill bit, The aforementioned drill bit is A first portion configured to be directly coupled to the head of the implant structure, A tool having a second portion extending from the first portion, wherein the second portion is configured to extend at least partially into the lumen of the implant structure.

258. The tool according to claim 257, wherein the second portion has a mechanical feature configured to be mechanically coupled in correspondence with the feature of the shaft, thereby enabling the transmission of rotational torque from the second portion to the shaft.

259. A coupling device for implanting an implant structure, wherein the implant structure has a proximal end with a head and a shaft extending from the head to the distal end of the implant structure, and the coupling device is A main body having a proximal end region and a distal end region configured to achieve mechanical connection to the distal end portion of the implant structure, A coupling device comprising a cap configured to connect to the proximal end region of the main body without directly connecting to the implant structure.

260. The coupling device according to claim 259, wherein the cap is coupled to a tool, receives rotational torque from the tool through the mechanical coupling, and transmits the rotational torque along the length of the body to the mechanical coupling and to the distal end portion of the implant structure.

261. The coupling device according to claim 259, wherein the coupling device is configured to connect to the implant structure only at the distal end portion of the implant structure.

262. The medical device is in a sterile state, as described in any one of claims 1 to 192 and 226 to 238.

263. The medical device is a medical device according to any one of claims 1 to 192 and 226 to 238, wherein the medical device has undergone a sterilization procedure to provide a sterile medical device.

264. A method for treating a fracture in bone tissue, the method comprising the steps of identifying the fracture in the bone tissue and inserting a medical device described in any one of claims 1 to 192, 226 to 238, and 262 to 263 into the bone tissue, wherein the medical device is inserted across the fracture.

265. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 1 to 76.

266. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 77 to 94.

267. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 95 to 101.

268. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 102 to 104.

269. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 105 to 108.

270. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 109 to 164.

271. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 165 to 176.

272. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 177 to 192.

273. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 226 to 238.

274. The method according to claim 264, wherein the medical device is the medical device described in any one of claims 262 to 263.

275. The method according to any one of claims 264 to 274, wherein the medical device is a screw.

276. The method according to any one of claims 264 to 275, further comprising the step of characterizing the fractured area with the medical device.

277. A method for characterizing a fracture site in bone tissue, the method comprising the steps of identifying the fracture site in the bone tissue and inserting a medical device described in any one of claims 1 to 192, 226 to 238 and 262 to 263 into the bone tissue, wherein the medical device is inserted across the fracture site, and the method further comprises the step of characterizing the fracture site with a sensor located within the medical device.

278. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 1 to 76.

279. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 77 to 94.

280. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 95 to 101.

281. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 102 to 104.

282. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 105 to 108.

283. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 109 to 164.

284. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 165 to 176.

285. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 177 to 192.

286. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 226 to 238.

287. The method according to claim 277, wherein the medical device is the medical device described in any one of claims 262 to 263.

288. The method according to any one of claims 277 to 287, wherein the medical device is a screw.

289. A set of medical devices, the set comprising at least one first medical device as described in any one of claims 1 to 192, claims 226 to 238 and claims 262 to 263, the set further comprising at least one second medical device configured to be insertable into bone tissue, the second medical device not comprising a sensor.

290. A set of medical devices according to claim 289, wherein each of the first medical device and the second medical device is a screw.

291. A set of medical devices according to claim 289, comprising a single first medical device and a plurality of second medical devices.

292. A set of medical devices according to claim 291, wherein each member of the set is a screw.

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