Medical device for implanting in bone tissue and characterizing bone fractures

Abstract

An intelligent medical device includes a structure configured to be at least partially implanted in a body, and an electronics cartridge configured to be inserted into the structure after implanting the structure in the body. The structure can be a cannulated screw for treating a bone fracture. The medical device includes an impedance sensor for monitoring and reporting the status of the bone fracture healing. The sensor includes an electronics cartridge assembly and an electrode associated with the cannulated screw or with the insertable electronics cartridge.

Description

[0001] Cross-reference of related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 120,158, filed December 1, 2020, and U.S. Provisional Patent Application No. 62 / 979,349, filed February 20, 2020, pursuant to 35 USC §119(e), which are incorporated herein by reference in their entirety for all purposes. Technical Field

[0003] This disclosure generally relates to medical devices having structures configured to extend at least partially into bone tissue. For example, the structure may be part of a screw, pin, rod, nail, joint replacement implant (e.g., hip, shoulder, knee, etc.), a spinal fixation device, or other orthopedic device. The medical device includes sensors for obtaining measurements indicating the healing status of fractured bone tissue in which the device is implanted, and communication circuitry for communicating such measurements to external devices. Background Technology

[0004] Reliable assessment of bone healing is fundamental to successful fracture treatment. Delayed or nonunion fractures occur frequently, in rates as high as 5%–10%, and can be extremely painful and dangerous to the patient's health, leading to unavoidable high costs. Current techniques for monitoring fracture healing rely on non-invasive imaging modalities such as X-rays, CT scans, ultrasound, and magnetic resonance imaging (MRI). Traditional reliance on radiographs for monitoring healing has limitations, as bridging callus formation in long bone fractures can take three months or longer. Computed tomography (CT) scans are a popular method and can assess bridging callus in the later stages of healing to confirm healing. The use of dynamic contrast-enhanced MRI and advances in nuclear imaging may be beneficial in assessing infected nonunion. Emerging evidence supports the use of ultrasound to detect bridging callus prior to radiological confirmation and its potential use in predicting high-risk patients for nonunion. However, each of these techniques tends to be most useful in the later stages of healing, and their effectiveness depends on patient adherence to regular imaging.

[0005] Therefore, it is desirable to provide a technique for characterizing fracture status in an automated manner at all stages of healing, independent of imaging or patient compliance. The concepts disclosed herein address these and other needs. Invention Overview

[0007] In short, this disclosure relates to medical devices, optionally referred to herein as implantable and / or smart medical devices, methods of manufacturing such medical devices, methods of using such medical devices, including, for example, methods of treatment with such medical devices and methods of characterizing healing with such medical devices, as well as other aspects disclosed herein. Medical devices typically have structures configured to extend at least partially into bone tissue. For example, the structure may be part of a screw, pin, rod, nail, joint replacement implant (e.g., hip, shoulder, knee, etc.), part of a spinal fixation device, or part of other orthopedic devices. In one embodiment, the medical device is a screw. Implantable smart medical devices include sensors for obtaining one or more measurements, for example, indicating the healing status of bone tissue in which the device is implanted, and communication circuitry for communicating such measurements to an external device.

[0008] For example, one aspect of this disclosure provides a smart medical device comprising a structure configured to be at least partially implanted in the body, and an electronic box configured to be inserted into the structure after implantation. The structure may be a hollow screw for treating fractures. The medical device includes an impedance sensor for monitoring and reporting the fracture healing status. The sensor includes components of the electronic box and electrodes associated with the hollow screw or the insertable electronic box.

[0009] On one hand, this disclosure relates to a medical device comprising a structure having a lumen extending at least partially therethrough and an insertable electronic cartridge including electronic components. The structure is configured to be at least partially implanted in the body, and the electronic cartridge is configured to be inserted into the lumen after being implanted in the implant structure.

[0010] This disclosure also relates to a medical device comprising a cannula structure having a plurality of electrodes on its outer surface, and an insertable electronic cartridge. The cannula structure has a lumen extending therethrough and is configured to be at least partially implanted in the body. The electronic cartridge includes electronic devices and is configured to be inserted into the lumen of the cannula structure such that one or more electrical couplings are established between the electronic devices and the plurality of electrodes upon such insertion.

[0011] This disclosure also relates to a medical device comprising a cannulation structure having at least one orifice through a structural sidewall, and an insertable electronic cartridge. The cannulation structure has a lumen extending therethrough and is configured to be at least partially implanted in the body. The electronic cartridge includes a plurality of electrodes and electronic devices electrically coupled to the electrodes. The electronic cartridge is configured to be inserted into the lumen and, upon such insertion, provide alignment between the plurality of electrodes and the at least one orifice.

[0012] This disclosure also relates to a medical device comprising a cannulation structure having a distal opening and a proximal opening, and an insertable electronic cartridge. The cannulation structure has a lumen extending therethrough and is configured to be at least partially implanted in the body. The electronic cartridge includes a plurality of electrodes and electronic devices electrically coupled to the electrodes. The electronic cartridge is configured to be inserted into the lumen and, upon such insertion, to position a first electrode of the plurality of electrodes at the distal opening of the cannulation structure and a second electrode of the plurality of electrodes at the proximal opening.

[0013] This disclosure also relates to a medical device comprising a short cannula structure having a distal opening and a proximal opening, and an insertable electronic cartridge. The cannula structure has a lumen extending therethrough and is configured to be at least partially implanted in the body. The electronic cartridge includes a plurality of electrodes and electronic devices electrically coupled to the electrodes. The electronic cartridge is configured to be inserted into the lumen and, upon such insertion, to position the plurality of electrodes beyond the distal opening of the cannula structure.

[0014] This disclosure also relates to a medical device pre-loaded with electronic components. The medical device is configured for at least partial implantation in the body and includes a structure having a head and an axis, each defining a head cavity and an axis cavity, respectively. The pre-loaded medical device also includes electronic components positioned in one or more head cavities and axis cavities, and at least one electrode associated with the axis and electrically coupled to the electronic components.

[0015] This disclosure also relates to a medical device comprising a cannula structure preloaded with an electronics cartridge. The cannula structure is configured for implantation within the body and includes a lumen extending at least partially through it. The electronics cartridge is at least partially located within the lumen and permanently fixed therein. The cannula structure has a plurality of holes through its sidewalls, and each of a plurality of electrodes is associated with one of the holes. The electronics cartridge includes electronic components, and each of a plurality of electrical contacts is aligned with one of the holes to establish electrical coupling between the electronic components and one of the electrodes.

[0016] On one hand, the medical devices of this disclosure can be used to assist in the treatment of fractures in bone tissue. For example, the medical device may be in the form of a screw placed through a fracture in bone tissue, wherein the screw helps to hold bone tissue adjacent to the bone portion together and thus provides a stabilizing function for the healing bone. Optionally, the medical device has little or no stabilizing function but is implanted in the fractured bone tissue, optionally through the fracture in the bone tissue, primarily or solely for characterizing the fracture during the healing process and thus providing a characterizing function. Optionally, the implanted medical device provides both stabilizing and characterizing functions. Particularly where the medical devices of this disclosure provide little or no stabilizing function, the medical devices of this disclosure can be used in conjunction with other medical devices, such as standard orthopedic screws without sensors, which primarily provide a stabilizing function. Therefore, on one hand, this disclosure provides a set of medical devices, wherein at least one member of the set is a smart medical device of this disclosure that provides a characterizing function (and optionally some stabilizing function), and at least one member of the set is used to provide a primary or specific stabilizing function. In use, the smart medical devices of this disclosure can be placed in the bone tissue at locations where a stabilizing function is not required, i.e., in non-loaded locations. Medical devices designed to provide primary or specific stability functions can be placed at the loading site within the bone tissue.

[0017] This disclosure also relates to an implantable medical device for characterizing fractures. The medical device includes an implant configured to be at least partially implanted in bone and across the fracture. The implant includes an impedance sensor comprising a first electrode and a second electrode, and a sensing module configured to obtain an impedance measurement between the first and second electrodes. The implant also includes a controller and a memory configured to process and store the impedance measurement, and communication circuitry configured to transmit the impedance measurement to an external device.

[0018] This disclosure also relates to an implantable medical device for characterizing fractures. The medical device includes a first implant and a second implant, each configured to be at least partially implanted in bone, and a third implant configured to be placed adjacent to bone across the fracture and fixed in situ by the first and second implants. The first implant has a first electrode, and the second implant has a second electrode. The medical device also includes an impedance sensor including the first and second electrodes and a sensing module. The sensing module is included in one or more of the first, second, and third implants and is configured to acquire an impedance measurement between the first and second electrodes. The medical device also includes a controller and a memory configured to process and store the impedance measurement, and communication circuitry configured to transmit the impedance measurement to an external device. The controller, memory, and communication circuitry may be included in one or more of the first, second, or third implants.

[0019] This disclosure also relates to a method for characterizing a fracture on the opposite side of a fracture using electrodes. The method includes acquiring, over time, multiple measurements of the tissue electrical properties associated with a single implant, located within bone tissue, and spanning the fracture using multiple electrodes. The multiple electrodes include a first electrode and a second electrode on the opposite side of the fracture. The method further includes processing the measurements to determine a characterization of the fracture corresponding to the state of fracture healing.

[0020] This disclosure also relates to a method for characterizing a fracture using electrodes in the fracture space. The method includes acquiring, over time, multiple measurements of tissue electrical properties associated with a single implant and located in the bone tissue at the fracture site using multiple electrodes. The multiple electrodes include a first electrode and a second electrode, each located in the fracture space. The method further includes processing the measurements to determine a characterization of the fracture corresponding to the fracture healing status.

[0021] This disclosure also relates to a method for characterizing a fracture using electrodes spanning the fracture gap. The method includes obtaining multiple measurements of tissue electrical properties over time using multiple electrodes positioned in the bone tissue at the fracture site. The multiple electrodes include a first electrode and a second electrode, each spanning the fracture gap. The method further includes processing the measurements to determine a characterization of the fracture corresponding to the fracture healing status.

[0022] This disclosure also relates to a method of manufacturing an implantable medical device. The method includes creating a plurality of holes through the sidewalls of a cannula structure configured to be at least partially implanted in the body and having a lumen extending therethrough. The method also includes associating electrodes with each of the plurality of holes, and associating an electronic cartridge with the lumen of the cannula structure. The electronic cartridge includes electronic components and a plurality of electrical contacts, wherein the association aligns each of the plurality of electrical contacts with one of the holes to establish electrical coupling between the electronic components and each electrode.

[0023] This disclosure also relates to a method of implanting a medical device. The method includes at least partially implanting an implantable structure into the body. The structure has a lumen extending at least partially through it. The method further includes inserting an electronic cartridge into the lumen after implanting the implantable structure.

[0024] This disclosure also relates to a tool for implanting an implant structure having a proximal end including a head, an axis extending distally from the head of the implant structure, and a lumen extending through the axis. The tool includes a drill bit and a mechanism for applying rotational torque to the drill bit. The drill bit includes 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.

[0025] This disclosure also relates to a coupling device for implanting an implant structure having a proximal end including a head and an axis extending distally from the head of the implant structure. The coupling device includes a body having a proximal region and a distal region. The distal region is configured to establish mechanical coupling with a distal portion of the implant structure. The coupling device may further include a cap configured to couple with the proximal region of the body without directly coupling with the implant structure.

[0026] Brief description of the attached figures

[0027] The exemplary features, nature, and various advantages of this disclosure will become apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein, unless otherwise stated, similar reference numerals or designations refer to similar parts in all the various views. The dimensions and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve the readability of the drawings. Specific shapes of the drawn elements are selected for easy identification in the drawings. One or more embodiments are described below with reference to the accompanying drawings, wherein:

[0028] Figure 1A , Figure 1B and Figure 1C It includes hollow screws that are partially threaded. Figure 1B The diagram illustrates the configuration of a smart medical device, wherein the hollow screw has a pair of electrodes and an electronic cartridge configured for insertion into the hollow screw to align a pair of electrical contacts carried by a cartridge with the pair of electrodes. Figure 1C ).

[0029] Figure 1D This is an illustration of a partially threaded hollow screw, where the unthreaded portion is coated with material.

[0030] Figure 2A , Figure 2B , Figure 3A , Figure 3B , Figure 4 , Figure 5A and Figure 5B This is a diagram of the various fixing mechanisms used to secure the electronic box in the hollow screw.

[0031] Figure 6A , Figure 6B and Figure 6C It can be used Figures 1A to 1C Illustrations of various configurations of threaded hollow screws for medical devices, including configurations with a single pair of electrodes. Figure 6A ), with a configuration of two pairs of electrodes ( Figure 6B ) and configuration with a row of electrodes ( Figure 6C ).

[0032] Figure 7A and Figure 7B This is a schematic diagram of a smart medical device including a hollow screw having a pair of electrodes, and an electronic cartridge configured for insertion into the hollow screw to align a pair of electrical contacts carried by a cartridge with the electrodes. Figure 7B (As shown in the cross-sectional view).

[0033] Figure 8A and Figure 8B This is a schematic diagram of a smart medical device including a hollow screw having a row of electrodes, and an electronic cartridge configured for insertion into the hollow screw to align some electrical contacts carried by the cartridge with the electrodes. Figure 8B (As shown in the cross-sectional view).

[0034] Figure 9A and Figure 9B yes Figure 1C Illustrations of different configurations of the electronic box head end.

[0035] Figure 10A and Figure 10B The illustration shows a smart medical device including a hollow screw, wherein the hollow screw has a pair of electrodes covered on the screw, a surface, and an electronic box configured for insertion into the hollow screw to align a pair of electrical contacts carried by a box with the electrodes.

[0036] Figure 11A and Figure 11B This is an illustration of a smart medical device including a hollow screw with four electrodes covering the surface of the screw, and an electronic box configured for insertion into the hollow screw to align four electrical contacts carried by the box with the conductive traces of the electrodes.

[0037] Figure 12A , Figure 12B and Figure 12C This is an illustration of a smart medical device comprising a separate hollow screw having a distal portion and a proximal portion, each of the distal and proximal portions having an electrode, and an electronic cartridge configured for insertion into the hollow screw to align electrical contacts carried by the cartridge with the electrode.

[0038] Figure 13A , Figure 13B , Figure 13C and Figure 13D It includes hollow screws ( Figure 13C Another configuration of the intelligent medical device is illustrated, wherein the hollow screw has a slot, and an electronic cartridge is configured for insertion into the hollow screw to align an electrode carried by the cartridge with the slot. Figure 13D ).

[0039] Figure 14A , Figure 14B , Figure 14C and Figure 14D It includes hollow screws ( Figure 14C An illustration of another configuration of a smart medical device, wherein the hollow screw has several holes, and an electronic cartridge is configured for insertion into the hollow screw to align electrodes carried by the cartridge with the holes. Figure 14D ).

[0040] Figure 15A , Figure 15B , Figure 15C and Figure 15D It includes hollow screws ( Figure 15C An illustration of another configuration of a smart medical device, wherein the hollow screw has a pair of holes, and an electronic cartridge is configured for insertion into the hollow screw to align a pair of electrodes carried by the cartridge with the pair of holes. Figure 15D ).

[0041] Figure 16A , Figure 16B , Figure 16C and Figure 16D This is an illustration of another configuration of a smart medical device, which includes a hollow screw ( Figure 16C ), and an electronic box configured for insertion into a hollow screw to align the tip electrode with the distal end of the hollow screw. Figure 16D ), and the cap electrode carried by the box is also exposed at the head of the screw.

[0042] Figure 17A , Figure 17B and Figure 17C This is an illustration of another configuration of a smart medical device, which includes a hollow screw ( Figure 17B ), and an electronic box configured to be inserted into a hollow screw so that a portion of the box carrying the distal and proximal electrodes extends through the distal end of the hollow screw ( Figure 17C ).

[0043] Figure 18A , Figure 18B , Figure 18C , Figure 18D , Figure 18E , Figure 18F , Figure 18G , Figure 18H , Figure 18I and Figure 18J This is an illustration of tools and technologies used for implanting smart medical devices.

[0044] Figure 19A , Figure 19B , Figure 19C and Figure 19D This is an illustration of a pre-loaded configuration of a smart medical device including screws with an integrated package of electronic components.

[0045] Figure 20A and Figure 20B This is an illustration of a pre-loaded configuration of a smart medical device including a hollow screw having a pair of electrodes on the screw surface that are coupled to an electronics package through a through-hole in the screw sidewall.

[0046] Figure 21A and Figure 21B This is an illustration of a pre-loaded configuration of a smart medical device including a hollow screw having four pin electrodes coupled to an electronics package through through holes in the screw sidewall.

[0047] Figure 22A and Figure 22B The block diagram shows the components of an exemplary implantable report processor (IRP) for a smart medical device that includes a sensor system for monitoring the healing status of fractures.

[0048] Figure 23 It is a graph of the impedance amplitude across the fracture as a function of time, measured using a smart medical device.

[0049] Figure 24A , Figure 24B Figure 25C Figure 24D and Figure 24E This is an illustration of intelligent medical devices for implantation in various types of fractures.

[0050] Figure 25A and Figure 25B These are flowcharts and schematic diagrams of methods for characterizing fractures using intelligent medical devices.

[0051] Figure 26A and Figure 26B These are flowcharts and schematic diagrams for another method of characterizing fractures using intelligent medical devices.

[0052] Figure 27A and Figure 27B These are flowcharts and schematic diagrams for another method of characterizing fractures using intelligent medical devices.

[0053] Figure 28 This is a map showing the range of smart medical devices in the patient's home. Invention Details

[0055] The intelligent medical devices disclosed herein include electronic components such as memory, a microprocessor and radio telemetry components, a power source (battery or supercapacitor), radio and antenna environmental tuning (MICS or Bluetooth), sensors for verifying in vivo bone healing measurements, and application-specific integrated circuit (ASIC) chips for sensors that detect motion relative to a first placement position of the sensors. These intelligent medical devices are used in, for example, orthopedic trauma and spinal products, such as hip fracture screws, long bone fracture screws (for use with plates), and pedicle screws for the spine.

[0056] Two configurations of the intelligent medical device are envisioned. One is referred to in this paper as the box configuration, and the other as the pre-loaded configuration.

[0057] Box configuration

[0058] refer to Figures 1A to 1C The smart medical device 100, in a cassette configuration, includes a structure 102 or an external body, characterized by a tubular body having a lumen 104 extending at least partially therethrough. The structure 102 is configured to be at least partially implanted within the body. The medical device 100 also includes an electronics box 106 or an internal body with electronic components, such as an ASIC chip, a power source, an antenna, etc. In some embodiments, the electronics box 106 may include a housing for accommodating the electronic components. In other embodiments, the electronic components may be fixed together or supported by a core element extending along the axis of the box. The electronics box 106 is configured to be inserted into and positioned within the lumen 104 of the structure 102 after implantation.

[0059] In some embodiments, the entire structure 102 is formed from a single biocompatible implantable-grade material. Exemplary implantable-grade materials include: titanium, stainless steel cobalt-chromium-molybdenum alloy, nickel-titanium oxide, ceramics, alumina, zirconium oxide, carbohydroxyapatite, or composite materials such as carbon fiber reinforced PEEK.

[0060] In some implementations, structure 102 can be segmented into different parts having different combinations of materials. For example, structure 102 may have a distal body, segment, or portion having a metallic material; a central body, segment, or portion having a material different from that of the distal portion; and a proximal body, segment, or portion having a metallic material similar to that of the distal portion. In an exemplary configuration, the metallic material of the distal and proximal portions may be an implantable grade material having a Young's modulus between 100 and 200 gigapascals (GPa), tensile strength of similar or different material interactions, while the material of the central portion may have the same material as the distal or proximal portion, having the same or different Young's modulus, or a different implantable grade material, such as a polymer. By having segmented structure 102, the different portions of the structure can have different strength and performance characteristics for a specific application. For example, the materials of the different portions, whether they are different or similar materials, can enable the structure 102 to penetrate and anchor into the fractured bone to pull the fracture together for healing. Structure 102 configured in this way can support sensing operations of medical device 100. For example, it can support electrochemical impedance spectroscopy (EIS) measurements across fracture sites.

[0061] In configurations where the electronic cartridge 106 includes a shell or core element, the shell or core element may be formed of an electrically insulating, non-conductive implantable material. In some embodiments, the electronic cartridge 106 may be configured to enhance the healing response at the implantation site. For this purpose, the electronic cartridge 106 includes a mechanism for delivering a catalytic substance that generates gaseous oxygen through a chemical reaction and enhances the oxygenation zone at the implantation site. In some configurations, the mechanism is a reservoir of catalytic substance that releases one or more times after implantation under the control of a time-release controller. In other configurations, the mechanism is a catalytic substance coating added to the cartridge during electronic processing of the cartridge. In any configuration, the material released by the cartridge mechanism generates an energy reaction to release an oxygen-rich environment to the local area surrounding the implant to improve healing.

[0062] exist Figures 1A to 1C In one embodiment, structure 102 is a hollow screw configured for implantation into bone tissue. In one configuration, the lumen 104 of the hollow screw 102 is configured to receive an implantation tool during implantation of the screw 102 into the bone tissue. In another configuration, the lumen 104 may be configured to receive a support element, such as a "blank" box, which temporarily fills the lumen to provide support for the hollow screw 102 and reduce the likelihood of the screw 102 breaking when implanted into the bone.

[0063] Continue to refer to Figures 1A to 1C The hollow screw 102 includes a shaft 118 with an outer diameter of 4 mm or greater and a head 119. The length of the shaft 118 varies depending on the application of the medical device 100. For example, in applications related to hip fractures of the femoral head, the length of the shaft 118 may be approximately 115 mm. The hollow screw 102 includes a shaft 118 having a continuous thread 111 around a portion thereof, which defines a threaded portion 112 of the screw configured to secure the screw into the bone. The lumen 104 includes a shaft portion whose inner diameter is configured to receive an electron cartridge 106 and whose volume is configured to accommodate the electron cartridge. The electron cartridge 106 includes 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.

[0064] Each of the electronic box 106 and the cavity 104 has its own shape factor enabling the electronic box 106 to be placed into the cavity 104. (See reference) Figure 1B In one embodiment, the shape factors of the lumen 104 of the hollow screw 102 include a head portion 120 and a shaft portion 124, wherein the inner diameter of the head is larger than the inner diameter of the shaft. The head portion 120 of the lumen 104 may correspond to the head portion 119 of the hollow screw 102, such as a recessed pocket in a polygonal head. The recessed pocket may be configured to receive a corresponding hexagonal head of an implantation tool and transmit the torque applied to the implantation tool to the screw during implantation of the device into the bone. Reference Figure 1CThe shape factors of the electronic box 106 include a head 122 and a shaft 126, wherein the outer diameter of the head 122 is larger than the outer diameter of the shaft 126.

[0065] In one embodiment, the electronics box 106 is configured to be fixed within the cavity 104. In another embodiment, the electronics box 106 is configured to be removed from the cavity without compromising the structural integrity of the electronics box or the structure.

[0066] For this purpose, various types of fixing mechanisms have been envisioned. For example, refer to Figure 2A and Figure 2B The head 122 of the electronic box 106 and the head portion 120 of the cavity 104 of the hollow screw 102 can be sized relative to each other such that a frictional fit 182 is created when the box is fully inserted into the cavity 104 of the screw. In this configuration, the head 122 of the electronic box 106 can be forced, for example, hammered into the head portion 120 of the cavity 104 of the hollow screw 102 to establish a frictional fit. In a variation of this configuration, the frictional fit can be obtained based on the geometry of the head portion 120 of the cavity 104 of the hollow screw 102 and the head 122 of the electronic box 106. For example, the head portion 120 of the cavity 104 can be elliptical, and a frictional fit between it and the head 119 of the hollow screw can be obtained by rotating the head 122 of the box, for example, by a quarter turn.

[0067] refer to Figure 3A and Figure 3B In another embodiment, the head 122 of the electronic case 106 and the head portion 120 of the cavity 104 of the hollow screw 102 include complementary mechanical features that create mechanical coupling 184 when the case is fully inserted into the cavity 104 of the screw. In one configuration, the mechanical feature of the electronic case 106 is a toothed protrusion 186, and the mechanical feature of the hollow screw 102 is an enlarged annular region 188 of the head portion 120 of the cavity 104 of the screw. In this configuration, the head 122 of the electronic case 106 can be pushed into the head portion 120 of the cavity 104 of the hollow screw 102 until the toothed protrusion 186 engages in place in the annular region 188, thereby establishing mechanical coupling 184 to hold the electronic case 106 in place within the hollow screw by preventing the case from moving outward from the hollow screw. In a variation of this configuration, snap-fit ​​features, such as circular or hexagonal rings, may extend around the entire head 122 of the electronic box 106 and snap-fit ​​into the ring area 188.

[0068] refer to Figure 4In another embodiment, a portion of the shaft 126 of the electronic cartridge 106 below the head 122 includes a threaded portion 190 configured to engage a complementary threaded portion (not shown) in the lumen 104 of the hollow screw 102. In this configuration, the electronic cartridge 106 has a circular cross-section along its length. The lumen 104 of the hollow screw 102 also has a circular cross-section; thereby allowing the electronic cartridge 106 to rotate within the lumen 104 and the threaded engagement of the assemblies 102, 106. In this configuration, if desired, the electronic cartridge 106 can subsequently be removed from the hollow screw 102 by loosening it. In a variation of this configuration, the complementary threads may be located in the outer wall of the head 122 of the electronic cartridge and the inner wall of the head 119 of the hollow screw 102. In this configuration, the head 119 of the hollow screw includes features on its outer surface that couple with an implantation tool to allow the screw to rotate during implantation.

[0069] refer to Figure 5A and Figure 5B In another embodiment, a portion of the shaft 126 of the electronics cartridge 106 below the head 122 includes an interlocking feature 192 comprising a plurality of grooves around the circumference of the shaft. In this configuration, a crosslinking agent is applied to the interlocking feature 192 before the electronics cartridge 106 is inserted into the lumen 104 of the hollow screw 102. The adhesive 194 may be, for example, a biocompatible epoxy resin such as polymethyl methacrylate (PMMA) or silicone. After the electronics cartridge 106 is fully inserted into the lumen 104 of the hollow screw 102, a crosslinking agent interface 194 is formed between the interlocking feature 192 and the inner wall 196 of the hollow screw 102.

[0070] Other envisioned securing mechanisms include a peelable surface on the underside of the head 122 of the electronic box 106, which exposes an adhesive surface when peeled off. When the electronic box 106 is fully inserted into the cavity 104 of the hollow screw, the adhesive surface abuts the bottom surface of the head portion 120 of the cavity, thereby securing the electronic box 106 in place.

[0071] refer to Figure 1B and Figure 1DIn some embodiments, the hollow screw 102 includes an outer surface 113 and one or more electrodes 128, 130 located on the outer surface. Electrodes 128, 130 may be arcuate pad electrodes having a radius of curvature similar to that of the shaft 118, and may extend along a groove between adjacent windings of the thread 111 defining the threaded portion 112. For example, each electrode 128, 130 may extend about the shaft 118 between 30 degrees and 180 degrees. Electrodes 128, 130 are made of a conductive implantable material with low resistivity. Exemplary materials include platinum, platinum-iridium, gold, gold-plated copper, silver, or other low-resistivity materials for electronic connection paths. Electrodes 128, 130 are electrically isolated from the shaft 118 of the hollow screw 102. For this purpose, an electrically insulating material may be located between the surfaces of electrodes 128, 130 that would otherwise contact the outer surface 113 of the shaft 118. The sealed feedthrough 115 extends through the sidewall 117 of the hollow screw 102 and provides electrical coupling between the electrodes 128, 130 and the interior 121 of the hollow screw. The feedthrough 115 can be a conventional ceramic feedthrough, a glass feedthrough, or a co-fired ceramic feedthrough with gold-bonded conductors.

[0072] refer to Figure 1D In an embodiment of the hollow screw 102 with partial threads, such as Figures 1A to 1C In one embodiment, an electrically insulating layer 174 may be applied to the unthreaded portion 172 of the screw to form a coated area. This material may be, for example, titanium dioxide or aluminum oxide applied to the unthreaded portion 172 using anodizing. Titanium dioxide has a similar electrical resistance to cobalt chromium oxide, which is an excellent electrical insulator. Alternatively, the material may be a diamond material applied to the unthreaded portion 172 using chemical vapor deposition to obtain a highly insulating coating. The material may also be a ceramic material applied to the unthreaded portion 172 using chemical plating vapor deposition to initiate coating bonding, or a liquid metal reflow of conductive or non-conductive metal induced by a eutectic adhesion method.

[0073] To minimize coating shear, the small diameter of the threaded portion 112 of the hollow screw 102 is increased by an amount substantially equal to the thickness of the material layer 174. Therefore, the outer diameter of the coated area of ​​the hollow screw 102 is generally equal to the small diameter of the threaded portion 112 of the hollow screw 102.

[0074] Electrodes 128 and 130, in combination with other electronics of the medical device 100, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor, which is used as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. Details of the EIS sensor are further disclosed below. Electrodes 128 and 130, in combination with other electronics of the medical device 100, can define a communication interface. Details of the communication interface are further disclosed below.

[0075] refer to Figure 1C In some embodiments, the electronic cartridge 106 includes an outer surface and one or more electrical contacts 132, 134 located on the outer surface, the contacts 132, 134 being configured to be electrically coupled to one or more electrodes 128, 130 when the electronic cartridge is inserted into a lumen. If the space between two electrodes 128, 130 or two electrical contacts 132, 134 is filled with a conductive fluid, an insulating seal 133 between the electrical contacts 132, 134 prevents harmful electrical contact between them. The insulating seal 133 may be an O-ring or a compliant overmolded silicone wiper. Each of the hollow screw 102 and the electronic cartridge 106 includes corresponding features for aligning one or more electrodes 128, 130 with one or more electrical contacts 132, 134 when the electronic cartridge is inserted into a lumen 104. These features may be complementary mechanical features, such as grooves in the surface of either the hollow screw 102 or the electronic cartridge 106 and protrusions extending from the other in the screw and the electronic cartridge.

[0076] refer to Figure 1B and 6A to Figure 6C The hollow screw 102 includes a proximal end 136, a distal end 138, and one or more electrodes along the axis 118 between the proximal and distal ends. Different numbers and arrangements of electrodes are envisioned.

[0077] For example, refer to Figure 1B and Figure 6A In some configurations, the hollow screw 102 may have a single pair of spaced-apart electrodes on the shaft 118, including a distal electrode 130 near the distal end 138 and a proximal electrode 128 near the proximal end 136. Figure 1B In this configuration, electrodes 128 and 130 are located on the shaft 118 on either side of the threaded portion 112 of the hollow screw 102, and can be spaced 20-30 mm or more apart. Figure 6A In this configuration, each of electrodes 128 and 130 is positioned on the shaft between adjacent windings of the thread 111 of the shaft, and may be spaced 20-30 mm or more apart. Electrodes 128 and 130 may be arc-shaped pad electrodes with a radius of curvature similar to that of the shaft 118, and may extend along the groove between adjacent windings of the thread 111. For example, each electrode 128 and 130 may extend around the shaft 118 between 30 degrees and 180 degrees.

[0078] refer to Figure 6BIn some embodiments, the hollow screw 102 may have two pairs of electrodes along the shaft 118. A pair of distal electrodes 130, 150 are located near the distal end 138, and a pair of proximal electrodes 128, 148 are located near the proximal end 136. In one configuration, electrodes 128, 130, 148, 150 may be located between adjacent windings of the thread 111 of the shaft 118. Electrodes 128, 130, 148, 150 within a pair may be spaced apart by a distance between 2 and 10 mm, and electrode pairs may be spaced apart by a distance between 20 and 30 mm or greater. Electrodes 128, 130, 148, 150 may be arcuate pad electrodes having a radius of curvature similar to that of the shaft 118, and may extend along a groove between adjacent windings of the thread 111. For example, each electrode 128, 130, 148, 150 may extend 30 degrees and 180 degrees around the shaft 118.

[0079] refer to Figure 6C In some embodiments, the hollow screw 102 may have a row of electrodes 164 along an axis 118 between its distal end 138 and proximal end 136. In one configuration, each electrode in the array of electrodes 164 may be located between adjacent windings of the thread 111 on the axis 118 and may be spaced apart by a distance between 2 and 10 mm. The electrodes of the array of electrodes 164 may be arcuate pad electrodes having a radius of curvature similar to that of the axis 118 and may extend along a groove between adjacent windings of the thread 111. For example, each electrode in the array of electrodes 164 may extend between 30 degrees and 180 degrees around the axis 118.

[0080] refer to Figure 7A and Figure 7B The schematic diagram illustrates a configuration of a medical device 100 with a single pair of electrodes 128, 130, in which the electrodes are electrically insulated from each other. For example, the shaft 118 extending between the proximal end 136 and the distal end 138 of the hollow screw 102 can be formed of a non-conductive material, or it can be coated with an electrically insulating material. In either case, one or more electrodes 128, 130 are separated by an insulating region 152. Additional insulating regions 155, 156 on the electrode 128, 130 sides electrically isolate the electrodes 128, 130 from the surface of the hollow screw 102, and these regions may be conductive.

[0081] refer to Figure 8A and Figure 8B The schematic diagram shows a configuration of a medical device 100 having a row of electrodes 164, in which the electrodes are electrically isolated from each other. For example, the shaft 118 extending between the proximal end 136 and the distal end 138 of the hollow screw 102 can be formed of a non-conductive material, or it can be coated with an electrically insulating material. In either case, one or more electrodes 128, 130 are separated by an insulating region 158.

[0082] refer to Figure 1C , Figure 7B and Figure 8B As previously described, the electronics box 106 includes a proximal end 140, a distal end 142, a head 122 at the proximal end, and a shaft 126 extending from the head to the distal end. The electronics box 106 is configured to electrically couple the electrodes 128, 130, 148, 150, 164 of the hollow screw 102 to electronic devices housed within the box.

[0083] Therefore, and refer to Figure 1C and Figure 7B In some embodiments, the electronic housing 106 includes an outer surface and a pair of electrical contacts 132, 134 on the outer surface, configured to electrically couple to a pair of electrodes 128, 130 of the hollow screw when the electronic housing is inserted into the cavity of the hollow screw. The pair of electrical contacts 132, 134 extends through the wall of the housing of the electronic housing 106 to electrically couple to electronic devices within the housing. As mentioned above, the housing is made of a non-conductive material. Therefore, the pair of electrical contacts 132, 134 are electrically insulated from each other.

[0084] refer to Figure 8B In some embodiments, the electronics box 106 includes an outer surface and a row of electrical contacts 166 on the outer surface, configured to be electrically coupled to an array of electrodes 164 when the electronics box is inserted into the lumen of a hollow screw. Each electrical contact 166 included in the array of electrical contacts extends through the wall of the housing of the electronics box 106 to be electrically coupled to electronic devices within the box. As mentioned above, the housing is made of a non-conductive material. Therefore, the electrical contacts 166 are electrically isolated from each other.

[0085] refer to Figure 1C , Figure 7B and Figure 8B The electronics included in the electronics box 106 can be associated with one or more electronic assemblies located on one or both of the head 122 and the shaft 126. The electronics in the electronics box 106 include an implantable report processor (IRP), details of which are described below. Figure 22A and Figure 22B Further details are provided. Regarding the structure of the IRP, in some embodiments, the IRP includes one or more antennas 144, 145, one or more rechargeable power sources 154, and one or more electronic assemblies, including:

[0086] A communication circuit that enables communication between a device and another device (implanted or external);

[0087] One or more sensors may be used to perform one or more of the following: 1) detecting, measuring, and / or monitoring one or more different aspects (anatomical, physiological, metabolic, and / or functional) of body tissues; 2) detecting, measuring, and / or monitoring one or more aspects of the condition or function of the body or body segment / joint (fracture healing, movement, including measuring the position, angle, velocity, and acceleration of body segments and joints); and / or 3) detecting, measuring, and / or monitoring one or more aspects of orthopedic devices or implants; and

[0088] Various other components that enable the medical device 100 to operate, such as memory, switches, processors, etc.

[0089] Electronic devices are located within the electronics housing 106 to minimize load on electronic components, particularly more sensitive electronic devices such as processors, CPUs, communication circuits, and ASICs, or power sources such as capacitors, batteries, or storage cells. For this purpose, electronic devices are typically placed away from high-stress areas of the medical device 100, but rather in the least-loaded portion of the device. For example, in the case of the medical device 100 for treating fractures, high-stress areas include: a) the interface change from the head to the shaft body due to torque loads during implantation and compression at implantation; b) the transition from the thread to the distal end of the shaft body due to diameter changes, and torque loads and compression at implantation; and c) the center of the shaft body itself due to torque, moment, and axial stress concentration in this area. Therefore, sensitive electronic devices such as processors, CPUs, communication circuits, and ASICs are located at the proximal end of the electronics housing 106, while less sensitive electronic devices, such as power source 154, are located in the central region of the housing. In some embodiments, electronic devices may be placed in high-stress areas of the medical device 100 but may be configured to withstand stress, for example, by having flexibility to allow some deformation under load conditions of the device.

[0090] In applications involving multiple medical devices, the device at the implantation site with the least load, i.e., the site of least stress on the implanted medical implant, can be selected as the smart medical device 100. For example, in the case of the medical device 100 used to treat femoral neck fractures using an inverted triangle method, such as... Figure 24B As shown, the position of minimum load corresponds to the point of the inverted triangle. Therefore, the medical device 100 can be placed at the point of the inverted triangle, where it will primarily serve to characterize the portion and its healing. A medical device used entirely or primarily for stabilization, optionally without sensors, can be placed at other locations on the inverted triangle to firmly hold the bone tissue together during healing.

[0091] Therefore, one aspect of this disclosure provides a set of medical devices, namely at least two medical devices, optionally three, four, or five, etc., used together for treating bone fractures. In one embodiment, the medical devices in this set are all screws. Particularly where the medical devices of this disclosure are intended to provide little or no stability function, the medical devices of this disclosure can be used in conjunction with other medical devices, such as standard orthopedic screws without sensors, and primarily provide stability for healing tissue. Thus, in one aspect, this disclosure provides a set of medical devices, wherein at least one member of the set is a smart medical device of this disclosure that provides characterization function (and optionally some stability function), and at least one member of the set is used primarily or specifically to provide stability function (and optionally not characterization function). For example, in one aspect, this disclosure provides a set of three medical devices, wherein one member of the set is a smart medical device of this disclosure that provides characterization function (and optionally some stability function), and two members of the set are used primarily or specifically to provide stability function, wherein optionally each medical device is a screw. Therefore, in use, the intelligent medical device of this disclosure can be optionally placed in the bone tissue at locations where stability is less required, i.e., at locations without load or with slight load. The group of medical devices intended to primarily or specifically provide stability can be placed at locations in the bone tissue with relatively high load. Thus, in one embodiment, this disclosure provides a method for treating femoral neck fractures using an inverted triangle approach, comprising placing a medical device of this disclosure, such as medical device 100, at one point of the inverted triangle, and placing sensorless medical devices at other points of the triangle.

[0092] On one hand, this disclosure provides a set of medical devices, including at least one first medical device of this disclosure, and further including at least one second medical device configured for insertion into bone tissue, wherein the second medical device does not contain a sensor. Optionally, each of the first and second medical devices is a screw. Optionally, the set includes a single, i.e., only one first medical device and a plurality, i.e., more than one, i.e., two or more second medical devices, wherein optionally each member of the set is a screw.

[0093] Regarding one or more antennas 144, 145 of the electronic box 106, in some embodiments, antenna 144 is entirely located inside the box and may be located in the head 122 of the box, or in the shaft 126 of the box, or partially in the head and partially in the shaft. For example, refer to Figure 9A The head 122a of the electronics box 106 may include an antenna 144a encapsulated in a material 147 such as PEEK. The antenna 144a may be a wire 146 or trace extending along an antenna plate 149 parallel to the bottom 151 of the head 122. (See reference) Figure 9BIn another embodiment of the electronic box 106, an antenna 144b is configured to serve as a communication antenna, and a rechargeable element may be located on top of the head 122b. The antenna 144b may be configured as a multiplanar array of protruding pins.

[0094] refer to Figure 1C In another embodiment of the electronics box 106, the antenna 145 is associated with the shaft 126. The antenna 145 may include a wire or trace wound around and extending along a portion of the shaft 126. For example, the antenna 145 may be a wire extending in a helical 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 interior of the hollow screw 102 when the electronics box 106 is inserted into the cavity 104 of the screw. The antenna 145 may be connected to electronics in the head 122 via an insulated trace or wire extending along the shaft 126 between the antenna and the head.

[0095] In some implementations, the antenna may be entirely outside the housing. In other implementations, the antenna may be partially inside the housing and partially outside the housing.

[0096] Regarding one or more energy sources 154 for the electronic box 106, see reference. Figure 7B and Figure 8B Energy source 154 may be associated with axis 126 of electronic box 106 and may be located in the intermediate region along the length of the axis for structural stability purposes. One or more energy sources 154 may be rechargeable and recharging mechanisms, such as coils, and may be located in the head of electronic box 106. In other embodiments (not shown), energy sources may be associated with head 122 of electronic box 106, and recharging mechanisms, such as coils, may be co-located with batteries in the head of electronic box. As will be further described below, one or more energy sources 154 may be one or more batteries, such as rechargeable batteries, and capacitors, such as supercapacitors. The electronics may include energy harvesting devices configured to harvest energy via electrostatic energy, wireless power transfer, and IR radiation.

[0097] Regarding the communication circuitry of the electronic box 106, in one embodiment, one or more communication components include a radio frequency (RF) transceiver coupled to antennas 144, 145 and configured to receive and transmit RF signals (e.g., Bluetooth or MICS). Reference Figure 9A The RF transceiver can be associated with an electronic assembly 153 in the form of a circuit board located in the header 122a. (See reference) Figure 9B The RF transceiver can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126. Details of RF telemetry communication are referenced below. Figure 22A Further details will be released.

[0098] In another embodiment, one or more communication components include tissue-conducting communication circuitry coupled to a pair of electrodes associated with medical device 100 and configured and positioned to contact tissue. The tissue-conducting communication circuitry may include a transmitter and a receiver. The pair of electrodes may correspond to electrodes 128, 130 of medical device 100. Thus configured, one or more communication components may be configured to enable at least one of the following: capacitive coupling between medical device 100 and another device; or current coupling between medical device 100 and another device. Reference Figure 9A The tissue conduction communication circuitry can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (See reference) Figure 9B The conductive communication circuitry can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126. Details of capacitive and current-coupled communication will be referenced below. Figure 22A Further details will be released.

[0099] Regarding the sensors in electronic box 106, in some embodiments, one or more sensors may include EIS sensors, which include electrodes 128, 130 of the medical device combined with electrode switches and sensing circuitry / modules of the medical device 100. Reference Figure 9A The electrode switches and sensing circuits / modules can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (See reference...) Figure 9B The electrode switches and sensing circuits / modules can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126. Details of the EIS sensor are referenced below. Figure 22A and Figure 22B Further details will be released.

[0100] In some implementations, one or more sensors may include an inertial measurement unit (IMU), such as an accelerometer or gyroscope, configured to output a signal corresponding to the motion of the medical device 100, and by association, the motion of the bone structure of the implanted device, and the motion or activity of the patient in which the device is implanted. The accelerometer may be a one-dimensional, two-dimensional, three-dimensional, or any available dimensional accelerometer. The electronics also include a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide indications of one or more of patient activity, medical device integrity (damage), and movement of the medical device relative to the implantation site (withdrawal). For example, the position of the accelerometer may be determined after implantation, and detection of changes in this position may be used to detect movement of the medical device at the implantation site. Reference Figure 9A An accelerometer or gyroscope and a processor may be associated with an electronic assembly 153 in the form of a circuit board located in head 122a. (Reference) Figure 9BAn accelerometer or gyroscope and a processor may be associated with an electronic assembly 157 in the form of a circuit box located in axis 126.

[0101] In some embodiments, one or more sensors may include stress sensors associated with the medical device 100. The electronics also include a processor coupled to the stress sensors to receive signals and configured to process the signals to provide indications of one or more of the following: the integrity of the medical device (damage) and movement of the medical device relative to its implantation location (withdrawal or indication of fracture healing). Reference Figure 9A The stress sensor and processor can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (Reference) Figure 9B The stress sensor and processor can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126.

[0102] In some embodiments, one or more sensors may include acoustic resonance sensors associated with the medical device 100 and configured to output signals corresponding to the acoustic vibration / movement level of the medical device. The electronics also include a processor coupled to the acoustic resonator to receive the signals and configured to process the signals to provide an indication of the degree of fixation of the medical device within the bone structure at the implantation site, which in turn can provide an indication of the bone healing status. The acoustic resonance sensor may be a single device associated with the vibrating medical device 100, or it may be a pair of devices including an acoustic transmitter at one end of the medical device 100 and an acoustic receiver at the other end of the device. The acoustic transmitter outputs an acoustic signal through the medical device 100. The acoustic receiver senses the acoustic signal and outputs an electrical signal having an amplitude indicating the intensity of the received acoustic signal. The processor may analyze the amplitude to determine the fracture healing status, wherein, over time, the progression of the acoustic signal towards lower amplitude (meaning less vibration of the medical device) indicates bone healing. Reference Figure 9A The acoustic resonance sensor and processor can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (Reference) Figure 9B The acoustic resonance sensor and processor can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126.

[0103] In some embodiments, one or more sensors may include stress sensors associated with the medical device 100 and configured to output a signal corresponding to the stress level in the medical device. The electronics also include a processor coupled to the stress sensor to receive the signal and configured to process the signal to provide an indication of the degree of fixation of the medical device within the bone structure at the implantation site, which in turn can provide an indication of the healing status of the bone. The stress sensor may be a single device associated with the medical device 100 that senses localized stress, or it may be a device that includes a stress sensor in or on the medical device 100. The stress sensor senses mechanical stress in a portion of the medical device 100 and outputs an electrical signal having an amplitude indicating the magnitude of the stress. The processor may analyze the amplitude to determine the healing status of the fracture, where the progression of the stress amplitude to a lower amplitude (meaning stress in the medical device) over time indicates bone healing. Reference Figure 9A The stress sensor and processor can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (Reference) Figure 9B The stress sensor and processor can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126.

[0104] In some implementations, 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. (Reference) Figure 9A The temperature sensor and processor can be associated with an electronic assembly 153 in the form of a circuit board located in the head 122a. (Reference) Figure 9B The temperature sensor and processor can be associated with an electronic assembly 157 in the form of a circuit box located in shaft 126. In some embodiments, the temperature sensor can be associated with a hollow screw 102.

[0105] refer to Figure 9A The electronics in head 122a may also include other components associated with an electronic assembly 153 in the form of a circuit board beneath antenna plate 149, such as memory, power source switches, fuses, etc. The electronics in head 122a may also include battery contacts 195 extending to a power source (not shown) located in shaft 126 of electronics cassette 106. In other embodiments, some electronics may be mounted on a printed circuit board located in shaft 126. Reference Figure 9B The electronic components in shaft 126 may include power source 154 and other components such as memory, power source switch, fuse, etc., which are associated with electronic assembly 157 in the form of a circuit box located in shaft 126. Details of these components will be referenced below. Figure 22A Further details will be released.

[0106] In some embodiments, the electronic cartridge 106 includes a mechanism configured to deliver a catalyst that generates gaseous oxygen at the implantation site through a chemical reaction. This mechanism may be a reservoir that releases the catalyst once or multiple times after implantation under the control of a time-release controller of a processor. The mechanism may also be a coating of the catalyst on the cartridge that is passively eluted into the body. The reaction of the catalyst with the body can be enhanced by delivering electrical stimulation via electrodes from a medical device.

[0107] refer to Figure 10A and Figure 10B In some embodiments, the smart medical device 1000, in a cassette configuration, includes a cannula structure 1002 having a lumen 1004 extending therethrough, and a plurality of electrodes 1028, 1030 on the outer surface of the structure. As with other embodiments of the medical device, the cannula structure 1002 is configured to be at least partially implanted in the body. The medical device 1000 also includes an electronics box 1006 containing electronics. The electronics box 1006 is configured to be inserted into the lumen 1004 of the cannula structure 1002. Upon insertion, the electronics box 1006 establishes one or more electrical couplings 1008, 1010 between the electronics of the box and the plurality of electrodes 1028, 1030.

[0108] The cannula structure 1002 includes a conductive substrate 1012 having a threaded portion 1011. The electronic housing 1006 includes a first electrical contact 1016 and a second electrical contact 1022. The first electrical contact 1016 is positioned to contact the inner surface 1024 of the conductive substrate 1012, thereby establishing an electrical coupling 1010 between the electronic device and the first electrode 1030. The second electrical contact 1022 is positioned to contact a portion of the second electrode 1028, thereby establishing an electrical coupling 1008 between the electronic device and the second electrode 1028.

[0109] The outer surface of the conductive substrate 1012 is at least partially treated or coated with an electrically insulating material 1014. For example, the titanium conductive substrate 1012 may be anodized to make the surface electrically insulating. A first electrode 1030 of a plurality of electrodes corresponds to the exposed portion of the conductive substrate 1012 and is connected to the electronic housing 1006 via a first electrical contact 1016. The first electrical contact 1016 may be, for example, a leaf spring, a press-fit metal ring, a contact metal surface, etc. The surface of the first electrode 1030 and the surface in contact with the first electrical contact 1016 have no surface treatment or coating. This allows for electrical connection to the electronic housing 1006 via the conductive substrate 1012.

[0110] The second electrode 1028 of the plurality of electrodes covers a portion of the electrically insulating material 1014 at the proximal end of the cannula structure 1002 and is connected to the electronic box 1006 via the second electrical contact 1022. The second electrical contact 1022 may be, for example, a leaf spring, a press-fit metal ring, a contact metal surface, etc.

[0111] The second electrode 1028 is constructed by coating or treating the conductive substrate 1012 to form a conductive surface layer 1018 on top of the insulating material 1014. The coating forming the conductive surface layer 1018 is thin to maintain the strength of the cannula structure 1002 and to maintain an outer diameter similar to that of a conventional cannula structure. Electrical contact with the patient outside the area of ​​the second electrode 1028 can be prevented by a thin insulating treatment or coating 1020 and / or by slightly reducing the diameter of the cannula structure 1002 in the second electrode region to reduce contact with bone. The insulating treatment or coating 1020 can be added by a variety of processes, such as vapor deposition, electroplating, screen printing, or powder coating. In this embodiment, the conductive surface layer 1018 surrounds the insulating head of the conductive substrate 1012 and covers the interior of the drive socket 1026.

[0112] The two electrical contacts 1016, 1022 of the electronic box 1006 are separated from each other by an insulating seal 1032. The insulating seal 1032 prevents harmful electrical contact between the two electrodes 1028, 1030 or the two electrical contacts 1016, 1022 if the space between them is filled with conductive fluid. The insulating seal 1032 can be an O-ring or a compliant overmolded silicone wiper. The second electrode 1028 can be protected from wear during insertion by sacrificing a lubricating coating. The second electrode 1028 can also be mechanically protected by placing a conductive and insulating coating in a recessed channel cut into the wall of the screw. Using this construction technique, any placement, shape, and size of the electrodes is possible.

[0113] Figure 10A and Figure 10B One implementation uses layers or coatings of insulating, non-conductive material 1014 and conductive material 1018 to generate multiple electrodes 1028, 1030 without altering the conductive substrate 1012 of the cannula structure 1002. Using masking, the coating can be applied to different latitudes along the length of the cannula structure 1002 to generate different electrodes. A region of the conductive substrate 1012 serves as one electrode.

[0114] refer to Figure 11A and Figure 11BIn some embodiments, the cassette configuration of the intelligent medical device 1100 includes a cannula structure 1102 having a lumen 1104 extending therethrough, and a plurality of electrodes 1128, 1130, 1136, 1140 on the outer surface of the structure, each electrode having a corresponding electrical contact 1134, 1138, 1142, 1144, also on the outer surface of the structure. As with other embodiments of the medical device, the cannula structure 1102 is configured to be at least partially implanted in the body. The medical device 1100 also includes an electronics box 1106 containing electronics. The electronics box 1106 is configured to be inserted into the lumen 1104 of the cannula structure 1102. Upon insertion, the electronics box 1106 establishes one or more electrical couplings (not shown) between the electronics of the box and the plurality of electrodes 1128, 1130, 1136, 1140.

[0115] The electronic box 1106 includes a plurality of electrical contacts 1131, 1135, 1139, and 1143, the number of which is equal to the number of electrodes 1128, 1130, 1136, and 1140. Each electrical contact 1131, 1135, 1139, and 1143 of the electronic box 1106 is positioned to contact one of the electrical contacts 1134, 1138, 1142, and 1144 of the insertion tube structure 1102 after being inserted into the insertion cavity 1104, thereby establishing electrical coupling between the electronic components of the box and the electrodes 1128, 1130, 1136, and 1140. The electrical contacts 1131, 1135, 1139, and 1143 of the electronic box 1106 can be, for example, leaf springs, press-fit metal rings, contact metal surfaces, etc.

[0116] The cannula structure 1102 includes a conductive substrate having an outer surface that is at least partially treated or coated with an electrically insulating material 1114. For example, the cannula structure 1102 may have a titanium substrate that is anodized to form surface electrical insulation. A plurality of electrodes 1128, 1130, 1136, 1140, such as the four in the example of FIG11, are formed by a conductive coating on the electrically insulating material 1114. Traces 1129, 1133, 1137, 1141, also formed by the conductive coating, extend from each electrode 1128, 1130, 1136, 1140 to a notch formed in the head 1119 of the cannula structure 102, wherein the traces terminate at corresponding electrical contacts 1134, 1138, 1142, 1144. An insulating coating covers the portion of each trace 1129, 1133, 1137, 1141 that extends between its respective electrodes 1128, 1130, 1136, 1140 and the respective electrical contacts 1134, 1138, 1142, 1144 of the cannulation structure 1102.

[0117] Three of the four electrodes, 1128, 1132, and 1136, are C-shaped and do not completely encircle the axis 1126 of the cannulation structure 1002. This allows one or more of the traces 1133, 1137, and 1141 of the three more distal electrodes 1130, 1136, and 1140 to pass through the gaps in 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 completely encircle the axis 1126 and can extend over the conductive connections of the other electrodes.

[0118] Figure 11A and Figure 11B The implementation scheme utilizes electroplating on conductive and non-conductive materials on the outer surface of the substrate of the cannulation structure 1102. First, a non-conductive layer insulates most or all of the substrate. Second, the substrate is masked and a conductive coating is applied to create electrical contacts 1134, 1138, 1142, 1144, electrical traces 1129, 1133, 1137, 1141, and electrodes 1128, 1130, 1136, 1140. Third, a non-conductive plating is applied only to the electrical traces 1129, 1133, 1137, 1141, thereby exposing the electrical contacts 1134, 1138, 1142, 1144 and electrodes 1128, 1130, 1136, 1140.

[0119] refer to Figures 12A to 12C In some embodiments, the cassette configuration of the intelligent medical device 1200 includes a multi-component cannulation structure 1202 having a lumen 1204 extending therethrough, and a plurality of electrodes 1228, 1230 on the outer surface of the structure. As with other embodiments of the medical device, the cannulation structure 1202 is configured to be at least partially implanted in the body. The medical device 1200 also includes an electronics cassette 1206 containing electronics. The electronics cassette 1206 is configured to be inserted into the lumen 1204 of the multi-component cannulation structure 1202. Upon insertion, the electronics cassette 1206 establishes one or more electrical couplings 1208, 1210 between the electronics of the cassette and the plurality of electrodes 1228, 1230.

[0120] The multi-part cannulation structure 1202 includes a distal part 1212 and a proximal part 1214, each having a conductive substrate 1216a, 1216b, the outer surface of which is at least partially coated with an electrically insulating coating 1218. For example, the distal part 1212 and the proximal part 1214 may have titanium substrates 1216a, 1216b, which are anodized to make the surface electrically insulating. The distal part 1212 includes a threaded portion 1220. Although the multi-part cannulation structure 1202 described herein includes two parts 1212, 1214, each having electrodes 1228, 1230, the cannulation structure 1202 may have more than two parts. For example, the multi-part cannulation structure may include four parts, each having an electrode, and each part configured to be coupled to one or more adjacent parts.

[0121] Electronic box 1206 includes a housing 1240 for accommodating electronic components, and a first electrical contact 1222 and a second electrical contact 1224 external to the housing and coupled to the electronic components. Housing 1240 is configured to electrically isolate the two electrical contacts 1222 and 1224. For this purpose, housing 1240 may be made of a non-conductive material, or it may be a conductive material coated with an electrically 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 establishing an electrical coupling 1208 between the electronic component and the first electrode 1230. The first electrical contact 1222 may be, for example, a leaf spring, a press-fit metal ring, a contact metal surface, etc. The inner surface of the conductive substrate 1216a has no surface treatment or coating. This allows for electrical connection from the first electrode 1230 to electronic box 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 establishing an electrical coupling 1210 between the electronic device and the second electrode 1228. The second electrical contact 1224 can be, for example, a leaf spring, a press-fit metal ring, a contact metal surface, etc. The inner surface of the conductive substrate 1216b has no surface treatment or coating. This allows for an electrical connection from the second electrode 1228 to the electronic housing 1206 through the conductive substrate 1216b.

[0122] The first electrode 1230 and the second electrode 1228 correspond to the exposed areas of the respective conductive substrates 1216a and 1216b. Electrodes 1228 and 1230 can be constructed by masking the surfaces of the respective conductive substrates 1216a and 1216b before applying the electrically insulating coating 1218, or, if a coating has already been applied, by machine surface treatment of the conductive substrates to remove the electrically insulating coating. The first electrode 1230 and the second electrode 1228 are electrically isolated from each other by a non-conductive connector 1232 between the distal portion 1212 and the proximal portion 1214 of the cannulation structure 1202.

[0123] The non-conductive connector 1232 can be a crosslinking agent used to secure the proximal component 1214 to the distal component 1212 during implantation of the medical device 1200. For example, during implantation of the medical device 1200, the distal component 1212 is first inserted into an inlet hole drilled through the bone tissue. Next, a non-conductive crosslinking agent material is applied to the end of the proximal component 1214, and the component is inserted into the inlet hole until it is mechanically coupled to the distal component 1212. The coupling between the distal component 1212 and the proximal component 1214 can be provided by corresponding mechanical features 1234, 1236 of the components, such as corresponding sets of mating notches and protrusions. Next, an electronic cartridge 1206 is inserted into the lumen 1204 through the head 1238 of the proximal component 1214. In an alternative implantation procedure, the electronic cartridge 1206 may be inserted into the distal component 1212 before the proximal component 1214 is coupled to the distal component. In another process, distal component 1212 and proximal component 1214 can be assembled outside the body prior to implantation, and then used as described below. Figures 18A to 18J Any implantation tool and technique described herein is used to place it in the bone. The electronic box 1206 is then inserted into the assembled cannula structure 1202.

[0124] refer to Figures 13A to 13D In some embodiments, the cassette configuration of the intelligent medical device 1300 includes a hollow screw 1302 and an electronics cassette 1306 configured for insertion into the hollow screw. In this embodiment, the electronics cassette 1306 includes one or more electrodes, and the hollow screw 1302 includes one or more holes. In some configurations, various electronics of the electronics cassette 1306 are located in a head 1322 of the cassette, and a power source 1354 is located in a portion of the shaft 1326 of the electronics cassette below the head. This and other structures and characteristics of the hollow screw 1302 and the electronics cassette 1306 are consistent with those described above for... Figures 1A to 1C The hollow screw 102 and the electronic box 106 described in the implementation scheme are essentially the same. Therefore, these details will not be repeated here. Instead, for Figures 13A to 13D Further description of the intelligent medical device 1300 focuses on its unique features.

[0125] refer to Figure 13C The hollow screw 1302 includes a slot-shaped hole 1308 passing through its sidewall 1310. The slot 1308 is located in a region of the shaft 1318 of the hollow screw 1302 near the threaded region 1312 of the screw. In some embodiments, an electrically insulating coating is applied to the outer surface 1316 of the hollow screw 1302 in the region of the slot 1308.

[0126] refer to Figure 13DThe electronic housing 1306 includes a spring-loaded electrode assembly 1314 extending radially outward from the surface of a shaft 1326 of the housing. For this purpose, the electrode assembly 1314 is biased relative to the surface of the shaft 1326 to enable the electronic housing to switch between a compressed state and an expanded state. During the compressed state, the outer surface of the electrode assembly 1314 is substantially flush with the surface of the shaft, and during the expanded state, the outer surface of the electrode assembly 1314 is raised or offset from the surface of the shaft 1326 to extend through a slot 1308. The electrode assembly 1314 includes a pair of electrodes 1328, 1330 spaced at least 1 mm apart.

[0127] Continue to refer to Figure 13D The shape factors of the electrode assembly 1314, such as the geometric cross-section and thickness, and the distance d between the bottom of the head 1322 of the electronic box 1306 and the top of the electrode protrusion, make the electrode assembly 1314 aligned with and extend through the slot 1308 when the electronic box is fully inserted into the cavity 1304 of the hollow screw 1302, so as to position the electrodes 1328, 1330 outward from the outer surface 1316 of the hollow screw.

[0128] Hollow screw 1302 and electronic box 1306 may include one or more of the above references Figures 2A to 5B The described mechanism is similar to those used to secure the ink cartridge within the screw. Furthermore, the electrode assembly 1314, through the extension of the slot 1308, also serves to secure the electronic cartridge 1306 within the hollow screw 1302.

[0129] refer to Figures 13A to 13D During the implantation of the medical device 1300 for treating fracture 1342, a hollow screw 1302 can be implanted across the fracture, such that the fracture is located between opposite ends of the slot 1308, and preferably in the middle of the two ends. Therefore, when the electronic box 1306 is inserted into the hollow screw 1302, the electrodes 1328, 1330 are located on opposite sides of the fracture 1342.

[0130] Electrodes 1328 and 1330, in combination with other electronics of the medical device 1300, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor used as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. As further described below, in this arrangement, the medical device 1300 is able to collect data via electrodes 1328 and 1330 for the purpose of characterizing fracture 1342 and analyzing healing status. Electrodes 1328 and 1330, in combination with other electronics of the medical device 1300, can define a tissue conductive communication interface. Details of the tissue conductive communication interface are further disclosed below.

[0131] refer to Figures 14A to 14DIn some embodiments, the cassette configuration of the intelligent medical device 1400 includes a hollow screw 1402 and an electronics box 1406 configured for insertion into the hollow screw. In some configurations, various electronic components of the electronics box 1406 are located in the head 1422 of the box, and a power source 1454 is located in a portion of the shaft 1426 of the electronics box below the head. This and other structures and characteristics of the hollow screw 1402 and the electronics box 1406 are consistent with those described above for... Figures 1A to 1C The hollow screw 102 and the electronic box 106 described in the implementation scheme are essentially the same. Therefore, these details will not be repeated here. Instead, for Figures 14A to 14D Further description of the intelligent medical device 1400 focuses on its unique features.

[0132] refer to Figure 14C The hollow screw 1402 includes a row of holes 1408 passing through its sidewall 1410. Figure 14C In the hollow screw 1402, there are eight individual holes in an array of holes 1408. The array of holes 1408 is located in the region of the shaft 1418 of the hollow screw 1402 near the threaded region 1412 of the screw. In some embodiments, an electrically insulating coating is applied to the outer surface 1416 of the hollow screw 1402 in the region of the array of holes 1408. In some embodiments, the electrically insulating coating is applied over the outer surface 1416 of the hollow screw 1402 along its entire length excluding the threaded region 1412.

[0133] refer to Figure 14D The electronic box 1406 includes a row of electrodes 1414. In Figure 14D In the electronic housing 1406, there are eight individual electrodes in an array of electrodes 1414. The electrode array 1414 includes multiple individual electrodes separated by seals 1424, which seal and electrically isolate the individual electrodes from each other. In some embodiments, these seals 1424 correspond to regions of the hollow housing of the electronic housing 1406, which, as previously described, are formed of an electrically insulating material. In other embodiments, these seals 1424 may be rings formed of a non-conductive metal or polymeric material or a biocompatible elastomer, placed around the housing of the electronic housing 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 axis 1426 of the electronic housing 1406. In one configuration, the individual electrodes are annular electrodes.

[0134] Continue to refer to Figure 14DThe distance d between the bottom of the head 1422 of the electron cartridge 1406 and the top of the array of electrodes 1414 ensures that when the electron cartridge is fully inserted into the lumen 1404 of the hollow screw 1402, each individual electrode in the array of electrodes 1414 is aligned with a corresponding hole in the array of holes 1408. Due to the recessed arrangement of the individual electrodes relative to the axis 1426 of the electron cartridge 1406, an annular space is formed between the outer surface of the individual electrodes and the inner wall of the hollow screw 1402 after the electron cartridge 1406 is inserted into the hollow screw 1402. The electrode-tissue interface between the electrode surface and the tissue is established by target access within the annular space surrounding the electrodes in the array of electrodes 1414, through the holes in the hollow screw 1402.

[0135] Hollow screw 1402 and electronic box 1406 may include one or more similar to the above references. Figures 2A to 5B The described mechanism secures the cartridge within the screw. Furthermore, one or more electrodes in the array of electrodes 1414 can be configured to extend radially to at least partially extend into and possibly completely through one of the holes in the array of holes 1408. For this purpose, the electrodes can be formed from a shape-memory material, such as platinum or platinum-iridium, such that when the cartridge 1406 is placed in a defined position in an orthopedic location, temperature changes cause the electrodes to change from a set configuration to another shape-set configuration that extends the electrodes into the holes. The expansion change of the electrodes can be 0.001 inches or greater in the axial, radial, or both directions to extend the electrodes into and through the holes, thereby securing the cartridge 1406 in the hollow screw 1402 and improving contact between the electrode surface and the bone tissue interface.

[0136] refer to Figures 14A to 14D During the implantation of the medical device 1400 for treating fracture 1442, a hollow screw 1402 can be implanted across the fracture, such that the fracture is located between opposite ends of the array of holes 1408, and preferably, in the middle of the two ends. Therefore, when the electronic cartridge 1406 is inserted into the hollow screw 1402, one or more electrodes are located on opposite sides of the fracture 1442.

[0137] At least two selectable electrodes in the array of electrodes 1414, combined with other electronics of the medical device 1400, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor used as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. As further described below, in this arrangement, the medical device 1400 is able to collect data via selectable electrodes on the opposite side of the fracture 1442 for fracture characterization and healing status analysis purposes. The two selectable electrodes in the array of electrodes 1414, combined with other electronics of the medical device 1400, can define a tissue conductive communication interface. Details of the tissue conductive communication interface are further disclosed below.

[0138] refer to Figures 15A to 15D In some embodiments, the cassette configuration of the intelligent medical device 1500 includes a hollow screw 1502 and an electronics box 1506 configured to be inserted into the hollow screw. In some configurations, various electronic components of the electronics box 1506 are located in the head 1522 of the box, and a power source 1554 is located in a portion of the shaft 1526 of the electronics box below the head. This and other structures and characteristics of the hollow screw 1502 and the electronics box 1506 are consistent with those described above for... Figures 1A to 1C The hollow screw 102 and the electronic box 106 described in the implementation scheme are essentially the same. Therefore, these details will not be repeated here. Instead, for Figures 15A to 15D Further description of the intelligent medical device 1500 focuses on its unique features.

[0139] refer to Figure 15C The hollow screw 1502 includes a pair of holes 1508, 1509 passing through its sidewall 1510. These holes 1508, 1509 are located in the region of the shaft 1518 of the hollow screw 1502 near the threaded region 1512 of the screw. In some embodiments, an electrically insulating coating is applied to the outer surface 1516 of the hollow screw 1502 in the region of the pair of holes 1508, 1509. In some embodiments, the electrically insulating coating is applied to the outer surface 1516 of the hollow screw 1502 along its entire length excluding the threaded region 1512.

[0140] refer to Figure 15DThe electronic housing 1506 includes a pair of electrodes 1528 and 1530. Electrodes 1528 and 1530 are separated by a seal 1524, which seals and electrically isolates the individual electrodes from each other. In some embodiments, the seal 1524 corresponds to a region of the hollow shell of the electronic housing 1506, which, as previously described, is formed of an electrically insulating material. In other embodiments, the seal 1524 may be a ring formed of a non-conductive metal, polymer, or biocompatible elastomer, positioned around the outer shell of the electronic housing 1506. The distance between electrodes 1528 and 1530 may be at least 1 mm. Electrodes 1528 and 1530 are recessed relative to the outer surface 1520 of the axis 1526 of the electronic housing 1506. In one configuration, the individual electrodes 1528 and 1530 are annular electrodes.

[0141] Continue to refer to Figure 15D The distance d between the bottom of the head 1522 of the electron cartridge 1506 and the proximal electrode 1528 ensures that each electrode 1528, 1530 is aligned with its corresponding hole 1508, 1509 when the electron cartridge is fully inserted into the lumen 1504 of the hollow screw 1502. Due to the recessed arrangement of the individual electrodes 1528, 1530 relative to the axis 1526 of the electron cartridge 1506, an annular space is formed between the outer surface of the individual electrode and the inner wall of the hollow screw 1502 when the electron cartridge 1506 is inserted into the hollow screw 1502. An electrode-tissue interface is established between the electrode surface and the tissue by target access through the holes 1508, 1509 of the hollow screw 1502 into the annular space surrounding the electrodes 1528, 1530.

[0142] Hollow screw 1502 and electronic box 1506 may include one or more similar to the above references. Figures 2A to 5B The described mechanism secures the cartridge within screws. Furthermore, one or more of electrodes 1528 and 1530 can be configured to extend radially to at least partially extend into and possibly completely through one of holes 1508 and 1509, as referenced above. Figure 14D As described.

[0143] refer to Figures 15A to 15D During the implantation of the medical device 1500 for treating fracture 1542, a hollow screw 1502 can be implanted across the fracture, such that the fracture is located between a pair of holes 1508, 1509, and preferably in the middle between the holes. Therefore, when the electronic box 1506 is inserted into the hollow screw 1502, the electrodes 1528, 1530 are located on opposite sides of the fracture 1542.

[0144] Electrodes 1528 and 1530, in combination with other electronics of the medical device 1500, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor, which serves as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. As further described below, in this arrangement, the medical device 1500 is able to collect data through these electrodes for fracture characterization and healing status analysis purposes. Electrodes 1528 and 1530, in combination with other electronics of the medical device 1500, can define a tissue conductive communication interface. Details of the tissue conductive communication interface are further disclosed below.

[0145] refer to Figures 16A to 16D In some embodiments, the cassette configuration of the intelligent medical device 1600 includes a hollow screw 1602 and an electronics box 1606 configured for insertion into the hollow screw. In some configurations, various electronic components of the electronics box 1606 are located in a head 1622, and a power source 1654 is located in a portion of the shaft 1626 of the electronics box below the head. This and other structures and characteristics of the hollow screw 1602 and the electronics box 1606 are consistent with those described above for... Figures 1A to 1C The hollow screw 102 and the electronic box 106 described in the implementation scheme are essentially the same. Therefore, these details will not be repeated here. Instead, Figures 16A to 16D Further description of the 1600 intelligent medical device focuses on its unique features.

[0146] refer to Figure 16D The electronic housing 1606 includes a cap electrode 1628 associated with the head 1622 of the housing and a tip electrode 1630 at the distal end of the housing. The distance d between the bottom of the head 1622 of the electronic housing 1606 and the top of the tip electrode 1630 is such that when the electronic component housing is fully inserted into the cavity 1604 of the hollow screw 1602 (as shown in the image), the distance is such that when the electronic component housing is fully inserted into the cavity 1604 of the hollow screw 1602, ... Figure 16B As shown, the tip electrode 1630 is adjacent to the exposure at the distal end 1605 of the lumen 1604 of the hollow screw, and the cap electrode 1628 is exposed at the head 1619 of the screw. In this embodiment, exposure of the cap electrode 1628 and the tip electrode 1630 is provided without requiring sidewall grooves or holes, such as those included in the screw head 1619. Figures 13A to 15D The implementation plan.

[0147] Continue to refer to Figure 16DIn some embodiments, the cap electrode 1628 includes a first portion 1632 located in a plane parallel to the top surface of the head 1622, a second portion 1634 that bends 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 head side, and a third portion that bends 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 head side.

[0148] refer to Figure 16A The exposure of the cap electrode 1628 at the head 1619 of the hollow screw 1602 allows for the formation of an electrode-tissue interface 1640 between the third portion 1636 of the cap electrode 1628 and the surface of the bone tissue 1644 after the electronic cartridge 1606 is inserted into the hollow screw 1602. In this embodiment, since a portion of the cap electrode 1628, such as the first portion 1632 and possibly the second portion 1634, contacts the head 1619 of the hollow screw 1602, the head 1602 of the hollow screw can be coated with an electrically insulating material, or the entire hollow screw 1602 can be coated with an electrically insulating material.

[0149] In other embodiments (not shown), instead of a cap electrode 1628 exposed on the head 1622 of the electronic housing 1606, the housing may include an upper electrode inside the housing (at the head 1622 or in the upper region of the shaft 1626) exposed on the side of the housing to make electrical contact with the conductive portion of the hollow screw 1602. In this embodiment, the entire screw, except for the portion in contact with the upper electrode, will be coated with an electrically insulating material.

[0150] return Figure 16D The tip electrode 1630 is recessed relative to the outer surface 1620 of the axis 1626 of the electronic housing 1606. In one configuration, the tip electrode 1630 is an annular electrode. Due to the recessed arrangement of the tip electrode 1630 relative to the axis 1626 of the electronic housing 1606, an annular space is formed between the outer surface of the tip electrode 1630 and the inner wall of the hollow screw 1602 after the electronic housing 1606 is inserted into the hollow screw 1602. An electrode-tissue interface between the tip electrode 1630 and the tissue is established by target access through the distal end 1605 of the hollow screw 1602 into the annular space surrounding the tip electrode. A seal 1652 located around the axis 1626 and near the tip electrode 1630 prevents tissue and bodily fluids from entering portions of the medical device 1600 near the seal, particularly including the cap electrode 1628. The seal 1652 may be formed of a biocompatible elastomer or polymer material with a hardness of 20A or higher, or a polymer fiber doped material or a polymer encapsulation material that can expand when exposed to a solution, or a non-conductive metallic material.

[0151] Hollow screw 1602 and electronic box 1606 may include one or more similar to the above references. Figures 2A to 5B The described mechanism secures the housing within the screw. Furthermore, the tip electrode 1630 can be configured to expand radially and axially to at least partially extend through and possibly completely through the distal end 1605 of the hollow screw, as referenced above. Figure 14D The expansion can be used to secure the electronic box 1606 within the hollow screw 1602.

[0152] refer to Figures 16A to 16D During the implantation of the medical device 1600 for treating fracture 1642, a hollow screw 1602 can be implanted across the fracture, such that the fracture is located between the head 1619 and the distal end 1621 of the screw, and preferably in the middle between the head and the distal end. Therefore, when the electronic cartridge 1606 is inserted into the hollow screw 1602, the electrodes 1628 and 1630 are located on opposite sides of the fracture 1642.

[0153] Electrodes 1628 and 1630, in combination with other electronics of the medical device 1600, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor used as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. As further described below, in this arrangement, the medical device 1600 is able to collect data through these electrodes for fracture characterization and healing status analysis purposes. Electrodes 1628 and 1630, in combination with other electronics of the medical device 1600, can define a tissue conductive communication interface. Details of the tissue conductive communication interface are further disclosed below.

[0154] refer to Figures 17A to 17C In some embodiments, the cassette configuration of the intelligent medical device 1700 includes a hollow screw 1702 and an electronics box 1706, configured to be inserted into the hollow screw such that a portion of the electronics box extends through and beyond the distal end of the hollow screw. In some configurations, various electronic components of the electronics box 1706 are located in the head 1722 of the electronics box, and a power source 1754 is located in a first portion 1725 of the shaft 1726 of the electronics box below the head. This and other structures and characteristics of the hollow screw 1702 and the electronics box 1706 are similar to those described above for... Figures 1A to 1C The hollow screw 102 and electronic box 106 described in the implementation scheme. Therefore, these details will not be repeated here. Instead, for Figure 17A Further description of the intelligent medical device 1700 in Figure 17D focuses on its unique features.

[0155] refer to Figure 17CThe electronic housing 1706 includes a rigid proximal portion 1760, a rigid intermediate portion 1761, and a non-load-bearing, flexible distal portion 1762. The proximal portion 1760 includes a head 1722 and a first portion 1725 of a shaft 1726, where an energy source 1754 is located. In some embodiments, the different portions 1760, 1761, and 1762 of the electronic housing 1706 are made of the same implantable-grade material and have similar or different stiffness. For example, the proximal portion 1760 may be formed of a metallic material with a stiffness of RA 25 or a polymer with a stiffness of 95A or higher. The intermediate portion 1761 may be formed of the same material and have a similar stiffness to the proximal portion 1760. The flexible distal portion 1762 may be formed of the same material as the proximal portion 1760 and the intermediate portion 1761, but with less stiffness than those regions to allow the distal region to bend. In some embodiments, different portions 1760, 1761, and 1762 of the electronic housing 1706 are made of different implantable-grade materials having similar or different rigidities. In some embodiments, the flexible distal portion 1762 is formed of a matrix polymer.

[0156] The proximal portion 1760, the intermediate portion 1761, and the flexible distal portion 1762 are connected together to form a continuous shaft 1726. For this purpose, the first portion 1725 of the shaft 1726, the intermediate portion 1761, and the flexible distal portion 1762 can be connected together via a Morse taper connection, a single-lock thread mechanism, or a keyway and single-thread lock method, forming an interconnected portion with a specific axial load capacity and maintaining a flexible deflection of more than 1 degree on the central axis. The flexible distal portion 1762 of the shaft includes a pair of electrodes 1728 and 1730. The distance between the electrodes can be at least 1 mm. The electrodes 1728 and 1730 are typically flush with the outer surface of the shaft 1726 of the electronic housing 1706. In one configuration, the electrodes 1728 and 1730 are annular electrodes.

[0157] refer to Figure 17B In this embodiment, the hollow screw 1702 has a length significantly shorter than that of the electronic box 1706 and serves to secure the electronic box in place. In some embodiments, the hollow screw 1702 includes a shaft 1718 whose length is substantially equal to the length of a first portion 1725 of the shaft 1726 of the electronic box 1706, such that when the box is inserted into the screw, the intermediate portion 1761 and the flexible distal portion 1762 of the shaft 1726 extend through the end of the screw. In some embodiments, an electrically insulating coating is applied to the outer surface 1716 of the hollow screw 1702. In some embodiments, no electrically insulating coating is applied to the hollow screw 1702 along its entire length.

[0158] refer to Figures 17A to 17CDuring the implantation of the medical device 1700 for treating fracture 1742, an inlet hole of suitable size for receiving an electronic cartridge 1706 is formed across the fracture. The depth of the inlet hole is such that, when the electronic cartridge 1706 is later inserted and passed through a hollow screw 1702, the fracture 1742 is located between electrodes 1728 and 1730, and preferably in the middle between the electrodes. During implantation, the hollow screw 1702 is inserted into the inlet hole, after which the electronic cartridge 1706 is inserted and partially passed through the screw. For this purpose, the electronic cartridge 1706 may include a closed end lumen for receiving a core needle to push the intermediate portion 1761 and the flexible distal portion 1762 across the hollow screw 1702 and further into the inlet hole. When the electronic cartridge 1706 is inserted and passed through the hollow screw 1702, the electrodes 1728 and 1730 are located on opposite sides of the fracture 1742.

[0159] Hollow screw 1702 and electronic box 1706 may include one or more of the above references. Figure 2A-5B The described similar mechanisms secure the cartridge within screws. Furthermore, region 1720 of the flexible distal portion 1762 of the electronic cartridge 1706 can be configured to expand or swell upon exposure to fluid. For this purpose, the flexible distal portion 1762 can be made of a matrix polymer that expands upon exposure to sterile water or saline after implantation. The radial and / or axial expansion of region 1720 of the flexible distal portion 1762 serves to secure the electronic cartridge 1706 in place and result in close contact between the electrodes 1728, 1730 and the bone tissue interface.

[0160] Electrodes 1728 and 1730, in combination with other electronics of the medical device 1700, can define a sensor or sensor system configured to monitor the electrical properties of tissue. In some embodiments, the sensor system is an impedance sensor, which serves as an EIS sensor to detect the location of a fracture and monitor the healing status of such fracture. As further described below, in this arrangement, the medical device 1700 is able to collect data through these electrodes for fracture characterization and healing status analysis purposes. Electrodes 1728 and 1730, in combination with other electronics of the medical device 1700, can define a tissue conductive communication interface. Details of the tissue conductive communication interface are further disclosed below.

[0161] Method of implanting box-type configuration

[0162] Methods of implanting medical devices, such as Figure 1A and Figure 1BThe method shown includes at least partially implanting structure 102 into the body, and after implantation, inserting an electronic cartridge 106 into a lumen 104. The method also includes securing the electronic cartridge 106 to structure 102. Subsequently, after securing the electronic cartridge 106 to structure 102, the cartridge can be removed from lumen 104 without affecting the structural integrity of the structure or the cartridge. During implantation of structure 102 into the body, a support element can be inserted into lumen 104 to provide physical support along the length of the axis of structure 102. After securing structure 102 into the body, the support element is removed, and the cartridge is inserted into lumen 104.

[0163] refer to Figures 18A to 18G It provides such as Figure 1A and Figure 1B Further details of the method for implanting a medical device relative to a fractured bone are provided. The method includes a two-stage insertion process in which one or more cannulated screws are implanted into the bone tissue, and an electronic cartridge is inserted into at least one cannulated screw.

[0164] refer to Figure 18A The first guidewire 1802 is driven through the fracture 1804 of bone 1806 to reach, for example, within 5 mm of the subchondral bone, which is the outer region of the bone surrounding the bone marrow, i.e., the outer surface of the bone. The first guidewire 1802 has an outer diameter smaller than the inner diameter of the cannulated screw to be implanted. (Reference) Figure 18B The parallel drilling guide 1808 engages with the first guide wire 1802 for the purpose of creating a parallel guide wire path or an entry hole. (Reference) Figure 18C and Figure 18D Three entry holes were drilled in bone 1806 using a parallel drill guide 1808. A second guide wire 1810 and a third guide wire 1812 were inserted into the entry holes, and the drill guide was removed.

[0165] refer to Figure 18E The length of the hollow screw 1814 to be implanted in each inlet hole can be measured using a depth gauge (not shown). If the head 1818 of the hollow screw 1814 will be countersunk, the head is included in the measurement. Each hollow screw 1814 is placed on the corresponding guide wires 1802, 1810, 1812 and slid along the guide wires until the tip of the screw abuts the open end of its corresponding inlet hole.

[0166] refer to Figure 18F The hollow screw 1814 is screwed into each inlet hole using an insertion tool 1822. This tool includes a drill bit 1824 configured to engage the head 1818 of the hollow screw 1814 and has a lumen 1826 sized to receive and slide through guide wires 1802, 1810, 1812 (e.g., ...). Figure 18G (As shown).

[0167] refer to Figure 18G In some embodiments, the drill bit 1824 may have a hexagonal cross-section, sized to fit into a corresponding hexagonal socket of the head 1818. In this embodiment, the drill bit 1824 is placed on guide wires 1802, 1810, 1812 and slides toward and engages the head 1818 of the hollow screw 1814. The drill bit 1824 is then rotated to advance the hollow screw 1814 through the inlet hole and across the fracture 1804. The drill bit 1824 disengages from the head 1818 of the hollow screw 1814, and the guide wires 1802, 1810, 1812 are subsequently removed, leaving the hollow screw in place.

[0168] refer to Figure 18H In some embodiments, the drill bit 1824 may have a hexagonal cross-section, sized to fit into a corresponding hexagonal socket of the head 1818, and a support shaft 1828 extends from the drill bit and is configured to fit into the lumen of the hollow screw 1814. The support shaft 1828 may include features 1830, such as linear projections along all or a portion of the shaft, configured to engage corresponding features, such as linear slots or grooves along at least a portion of the inner sidewall of the shaft 1834 of the hollow screw 1814. Each of the drill bit 1824 and the support shaft 1828 also includes a lumen 1832, sized to receive and slide on guide wires 1802, 1810, 1812.

[0169] In this embodiment, a support shaft 1828 and a drill bit 1824 are placed on guide wires 1802, 1810, and 1812 and slid toward the head 1818 of the hollow screw 1814. The support shaft 1828 is positioned relative to the hollow screw 1814 to align a protrusion 1830 of the support shaft with a slot on the shaft 1834 of the hollow screw. The support shaft 1828 slides into the lumen of the hollow screw 1814 until the drill bit 1824 engages the head 1818 of the screw. The drill bit 1824, together with the support shaft 1828, rotates to advance the hollow screw 1814 through the hole and across the fracture 1804. The drill bit 1824 and the support shaft 1828 disengage from the hollow screw 1814, and then the guide wires 1802, 1810, and 1812 are removed, leaving the hollow screw in place. The support shaft 1828 provides support along the length of the shaft 1834 of the hollow screw 1814 during insertion and is used to distribute torque applied during rotation to the head 1818 region of the screw and the shaft 1834 of the screw. Distributing torque in this way reduces the possibility of the hollow screw 1814 breaking during implantation.

[0170] In an alternative configuration, the support shaft 1828 may be smooth along its length and may not include features such as linear protrusions or keys. This configuration supports the shaft 1834 of the hollow screw during insertion but is not used to transmit torque. In another alternative configuration, the support shaft 1828 may be a separate component inserted into the lumen of the hollow screw 1814 prior to engagement of the drill bit 1824. In this configuration, the support shaft 1828 may include features, such as linear protrusions or keys, that engage with corresponding features, such as grooves or channels, of the shaft 1834 of the hollow screw 1814. In this case, the drill bit 1824 includes features, such as hexagonal sleeves, configured to engage the hexagonal ends of the support shaft 1828 for the purpose of transmitting torque along the support shaft during drill bit rotation.

[0171] refer to Figure 18I In some embodiments, the hollow screw 1814 may be configured to be placed within the coupling device 1840 as part of an implantation procedure. The coupling device 1840 includes an annular body 1842 having a proximal region and a distal region, the proximal region having a proximal opening 1844 sized to receive the hollow screw 1814, and the distal region having a distal opening 1846 configured to receive and engage a distal portion 1848 of the hollow screw 1814. Engagement may be achieved through threaded features on the outer diameter of the distal portion 1848 of the hollow screw and threaded features on the inner diameter of the annular body 1842. Engagement may also be achieved through a locking mechanism. The coupling device 1840 may also include a cap 1850 configured to engage the proximal end of the annular body 1842. Engagement may be achieved through the corresponding threaded features of the cap 1850 and the annular body 1842. The cap 1850 also includes a feature 1852, such as a hexagonal sleeve, configured to engage with a drill bit. During implantation, the size of the inlet hole through the bone is sufficient to accommodate the annular body 1842 of the coupling device 1840. Figure 18I For clarity, the dimensions of the annular body 1842 relative to the hollow screw 1814 are not proportional. Typically, the thickness 1854 of the annular body 1842 is less than the diameter 1856 of the hollow screw 1814, and can be, for example, one-quarter to one-half the diameter of the hollow screw.

[0172] In this embodiment, a hollow screw 1814 is secured within a coupling device 1840. For example, the distal portion 1848 of the hollow screw is screwed into the distal opening 1846 of an annular body 1842, and a cap 1850 is coupled to the proximal end of the annular body. The coupling device 1840 and the hollow screw 1814 are positioned on corresponding guide wires 1802, 1810, 1812 and slide along the guide wires until the tip 1858 of the screw abuts the opening end of its corresponding hole. See also... Figure 18GThe drill bit 1824 may have a hexagonal cross-section, the size of which is adapted to fit into a corresponding hexagonal socket of the cap 1850 of the coupling device 1840. The drill bit 1824 is placed on guide wires 1802, 1810, 1812 protruding from the cap 1850 of the coupling device 1840 and slides toward and engages with the cap.

[0173] The drill bit 1824 is then rotated to advance the coupling device 1840 and the hollow screw 1814 through the inlet hole and across the fracture 1804. The drill bit 1824 rotates in the opposite direction to disengage the hollow screw 1814 from the coupling device 1840 and remove the coupling device from the inlet hole, leaving the hollow screw in place. At this stage, the hollow screw 1814 can be further rotated as needed by direct engagement with the drill bit to fully position the screw. For example, the hollow screw 1814 can be rotated to place the screw head in close contact with the bone to press the fractured bone portions together. The guide wires 1802, 1810, and 1812 are then removed from the hollow screw 1814. During the rotation of the coupling device 1840, the energy of the torque applied to the proximal end of the device is transferred along the length of the annular body 1842 to the distal end of the annular body 1842 and to the distal portion 1848 of the hollow screw, where the annular body is coupled to the screw. In this way, the transmission of torque along the axial length of the hollow screw 1814 is avoided. Distributing torque in this way reduces the likelihood of the hollow screw 1814 breaking during implantation.

[0174] In an alternative implantation procedure, the annular body 1842 can be used to implant the hollow screw 1814 without the cap 1850. In this embodiment, the proximal end of the annular body 1842 is configured to engage the drill bit 1824.

[0175] refer to Figure 18J After the hollow screw 1814 is inserted, the electronic cartridge 1820 is inserted into at least one hollow screw. In some embodiments, the electronic cartridge 1820 may be inserted into the screw in a two-step process. In the first step, an insertion tool similar to a syringe is used to inject and place the electronic cartridge 1820 into the hollow screw 1814. In the second step, refer to... Figures 2A to 5B The electronic box 1820 is secured in the appropriate position within the hollow screw 1814 using at least one of the above-described mechanisms.

[0176] In some implementations, a guide tool can be used to insert the electronic cartridge 1820 into the screw. Before the electronic cartridge 1820 can be installed, the guide wire at the center of the hollow screw 1814 is removed. Before removing the guide wire, the guide tool is placed on the guide wire. The tip of the guide tool has a tapered end aligned with the head of the hollow screw 1814. Placed in this manner, the guide tool extends beyond the surgical site but not beyond the end of the guide wire. As the guide tool aligns with the screw head, the guide wire is removed, and the electronic cartridge 1820 is fed downward within the guide tool until it slides into the hollow screw 1814.

[0177] Preload configuration

[0178] refer to Figures 19A to 19D In some embodiments, the pre-loaded smart medical device 1900 includes a structure 1902 having a head 1904 and an axis 1906, each defining a head cavity 1908 and an axis cavity 1910, respectively. In some embodiments, the medical device 1900 is a screw configured for implantation in bone tissue. The medical device 1900 also includes an antenna 1944 and an electronic assembly 1912 located in the head cavity 1908, and an energy source 1954 located in the axis cavity 1910. At least one electrode 1914 is associated with the axis 1906 and electrically coupled to the electronic assembly 1912 via a conductor 1916 passing through the sidewall of the axis 1906. Regarding the antenna 1944, it may be a wire 1946 or trace extending along an antenna plate 1949 encapsulated in a material 1947, such as PEEK, ceramic, or a material capable of communication and connection, such as RF signal transmission or reception. Regarding the energy source 1954, it is coupled to the electronic assembly 1912 via a pair of battery contacts 1955.

[0179] Preloaded smart medical devices can be structurally similar to any of the previously described cartridge configurations, except that the electronic cartridge is permanently fixed to the structure, such as within a hollow screw, during manufacturing. For example, a preloaded smart medical device can be prepared by inserting the electronic cartridge into a hollow screw and welding the head of the electronic cartridge into the head of the hollow screw, or by fixing the head in place with a biocompatible crosslinking agent, such as a silicone- or polyurethane-based crosslinking agent, and then hermetically sealing the assembly at each of the distal and proximal ends. In these preloaded configurations, one of the heads of the electronic cartridge and the hollow screw is configured to receive an implantation tool. For example, the electronic cartridge may include a sleeve head that engages with the implantation tool, or the head of the hollow screw may include features on its outer surface, such as… Figure 4 As shown, it is attached to the implantation tool.

[0180] The structural features of the pre-loaded configuration are generally the same as those described for the box-type configuration. Therefore, these features will not be described again here.

[0181] refer to Figure 20A and Figure 20B In some embodiments, the pre-loaded smart medical device 2000 includes a cannula structure 2002 configured for at least partial implantation within the body. The cannula structure 2002 has a lumen 2004 extending therethrough, a plurality of holes 2006, 2008 through sidewalls 2010, and a plurality of electrodes 2012, 2014 each associated with one of the holes. The medical device 2000 also includes an electronics box 2016 at least partially within the lumen 2004 of the cannula structure 2002. The electronics box 2016 includes electronic components, such as antennas, ASICs, power sources, etc. The electronics box 2016 also includes a plurality of electrical contacts 2018, 2020, each aligned with one of the holes 2006, 2008 to establish electrical coupling between the electronics of the box and each of the electrodes 2012, 2014.

[0182] The cannulation structure 2002 includes a substrate 2024 having an outer surface 2026 and an inner surface 2028. A first electrode 2012 of a plurality of electrodes is located on the outer surface 2026 of the substrate and has a feedthrough 2030 extending 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 located on the outer surface 2026 of the substrate and has a feedthrough 2032 extending through a second hole 2008 of a plurality of holes to the inner surface 2028 of the substrate.

[0183] In some embodiments, the substrate 2024 is formed of an electrically insulating material. In some embodiments, the substrate 2024 is formed of a conductive material coated with an electrically insulating material 2034. Figure 20B As shown, the substrate 2024 can be treated or coated to make the outer surface 2026, inner surface 2028, and inner walls 2036, 2038 of each hole 2006, 2008 electrically insulating. For example, the titanium substrate 2024 can be anodized to make the surface electrically insulating.

[0184] Electrodes 2012 and 2014 can be formed by coating or treating the outer surface 2026 of the substrate 2024 to create the outer portion of the electrodes. 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 also coated or treated. For example, the coating or treatment can be performed by electroplating or screen printing. After forming electrodes 2012 and 2014, for example by electroplating, the holes 2040 and 2042 through the electrodes can be filled with material to strengthen the sidewalls 2010 of the cannulation structure 2002, or the electrode electroplating process can be controlled to produce electrodes without holes to strengthen the sidewalls.

[0185] Electrodes 2012 and 2014 can have customized coating shapes, such as... Figure 20B As shown, they can be the shaped ends of conductive pins via the sidewall 2010 of the cannulation structure 2002. Using these construction techniques, electrodes of any number, size, and shape can be added to the surface of the screw. Electrodes 2012, 2014 are separated by an insulating seal 2046. If the space between the electrodes is filled with a conductive fluid, the insulating seal 2046 prevents harmful electrical contact between the electrodes. The insulating seal 2046 can be an O-ring or a compliant overmolded silicone wiper.

[0186] Continue to refer to Figure 20A and Figure 20B In one configuration, the electronic housing 2016 includes a connecting leg 2048 extending downward into the lumen 2004 of the cannulation structure 2002. The connecting leg 2048 includes a conductive center pin 2050 having a distal end forming a first electrical contact 2018, an insulating core 2052, and a conductive sheath surrounding a portion of the insulating core to form a second electrical contact 2020. Therefore, the electronic housing 2016 includes a feedthrough 2030 of a first electrode 2012 positioned on the inner surface 2028 of the contact substrate to establish an electrical coupling between the electronic device and the first electrode, and a feedthrough 2032 of a second electrode 2014 positioned on the inner surface of the contact substrate to establish an electrical coupling between the electronic device and the second electrode, and a second electrical contact 2020.

[0187] refer to Figure 21A and Figure 21B In some embodiments, the pre-loaded smart medical device 2100 includes a cannula structure 2102 configured for at least partial implantation within the body. The cannula structure 2102 has a lumen 2104 extending therethrough, a plurality of holes 2106a-2106d through sidewalls 2110, and a plurality of pin electrodes 2112a-2112d, each associated with one of the holes. The medical device 2100 also includes an electronics box 2116 at least partially within the lumen 2104 of the cannula structure 2102. The electronics box 2116 includes electronic components such as antennas, ASICs, power sources, etc. The electronics box 2116 also includes a plurality of electrical traces 2114a-2114d, each having a distal terminal 2116a-2116d aligned with one of the holes 2106a-2106d to establish electrical coupling between the electronics of the box and each pin electrode 2112a-2112d.

[0188] The cannulation structure 2102 includes a substrate 2124 having an outer surface 2126 and an inner surface 2128. In some embodiments, the substrate 2124 is formed of an electrically insulating material. In some embodiments, the substrate 2124 is formed of a conductive material coated with an electrically insulating material 2134. Figure 21BAs shown, material 2124 can be treated or coated to make the outer surface 2126, the inner surface 2128, and the inner walls of each hole 2106a-2106d electrically insulating. For example, the titanium substrate 2124 can be anodized to make these surfaces electrically insulating.

[0189] Pin electrodes 2112a-2112d can be coupled or press-fitted into holes 2106a-2106d and make contact with a corresponding one of the distal terminals 2116a-2116d. Pin electrodes 2112a-2112d can be rigid, or they can be spring-loaded pins biased to extend radially outward from holes 2106a-2106d. In a configuration where the substrate 2124 of the cannula structure 2102 is conductive but not coated with insulating material, pin electrodes 2112a-2112d have an insulating outer surface and a conductive core. Pin electrodes 2112a-2112d can also be bonded to holes 2106a-2106d using an insulating adhesive. Pin electrodes 2112a-2112d can be riveted into holes 2106a-2106d, and the ends of the pins can be flattened into electrodes during the riveting process. The pin electrodes 2112a-2112d can be formed together by filling the holes 2106a-2106d with a cured conductive material (e.g., conductive epoxy resin). This can help increase the strength of the sidewalls 2110 of the cannulation structure 2102 in the area of ​​holes 2106a-2106d.

[0190] Electrical components and features

[0191] The mechanical, material and other structural details of the box-type and pre-loaded configurations of the smart medical device, as well as their various implementations, have already been disclosed. The electrical and operational elements and features of the two configurations are now described.

[0192] refer to Figure 22A The configuration of the intelligent medical device includes an implantable report processor (IRP) 2203. The IRP 2203 includes a power source 2212, sensing electrodes 2221, electronic assembly 2210, antenna 2230, communication electrodes 2231 and 2233, and acoustic transducer 2236.

[0193] The circuitry of the electronic assembly 2210 may include one or more sensors 2222, electrode switches 2223, and sensing circuitry / modules 2227. As further disclosed below, in some embodiments, the sensing electrodes 2221, electrode switches 2223, and sensing circuitry / modules 2227 together serve as a sensor 2229 configured to monitor the electrical properties of tissue. For example, sensor 2229 may be an impedance sensor.

[0194] The circuitry of electronic assembly 2210 may include a fuse 2214, one or more power source switches 2216, 2218, a clock generator and power source management unit 2220, a memory 2224, a controller 2232, and communication circuitry 2225. Communication circuitry 2225 may include one or more of the following: a radio frequency (RF) transceiver 2226 and a filter 2228 coupled to antenna 2230; tissue conduction communication (TCC) circuitry 2238 coupled to communication electrode groups 2231, 2233; or audio data circuitry 2240 coupled to acoustic transducer 2236. Examples of some or all of these components are described elsewhere in this application or in U.S. Series 16 / 084,544, which are incorporated herein by reference in all jurisdictions where such inclusion is permitted. In one embodiment, electronic assembly 2210 may be an ASIC chip with the ability to be charged via a 2mF-8mF capacitor for processing and transmitting data packets.

[0195] As described above, IRP 2203 includes one or more sensors 2222, 2229. A “sensor” means a device or combination of components that forms a sensor and can be used to perform one or more of the following: 1) detecting, measuring and / or monitoring one or more aspects of the condition or function of a body or body segment / joint (fracture healing, movement, including measuring the position, angle, velocity and acceleration of body segments and joints), 2) detecting, measuring and / or monitoring one or more different aspects of body tissues (anatomical, physiological, metabolic and / or functional), and / or 3) detecting, measuring and / or monitoring one or more aspects of an orthopedic device or implant.

[0196] refer to Figure 22B And as mentioned above, in some embodiments, the IRP2203 includes an impedance sensor 2229 comprising sensing electrodes 2221, an electrode switch 2223, and a sensing circuit / module 2227. The sensing electrodes 2221 may include multiple individual electrodes 2231a-2231n. In some embodiments, the number of electrodes 2231a-2231n is at least two and may be up to eight or possibly more. Reference Figures 1A to 1C In some embodiments, sensing electrode 2221 may correspond to electrodes 128, 130 associated with hollow screw 102. (See reference...) Figures 13A to 13D In some embodiments, sensing electrode 2221 may correspond to electrodes 1328, 1330 associated with electronic box 1306. (See reference...) Figures 14A to 14D In some embodiments, sensing electrode 2221 may correspond to an array of electrodes 1414 associated with electronic box 1406.

[0197] return Figure 22BIn some embodiments, the sensing circuitry / module 2227 of 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 transconductance amplifier (GMC) 2241, and an analog-to-digital converter (ADC) 2243. In this configuration, the impedance sensor 2229 serves as an EIS sensor that measures frequency-dependent impedance through bodily anatomy for the purpose of characterizing fractures and determining healing status or fracture condition. For example, this type of EIS sensor is described in Monica C. Lin et al.'s "New Opportunities for Fracture Healing Detection: Impedance Spectroscopy Measurements Correlate to Tissue Composition in Fractures," Journal of Orthopaedic Research, published in December 2017, which is incorporated herein by reference.

[0198] Continue to refer to Figure 22B The medical device may include a sensor system 2229, such as an impedance sensor or an EIS sensor, comprising one or more sensing electrodes 2231a-2231n, and one or more components 2223, 2227 electrically coupled to the one or more sensing electrodes to monitor the electrical properties of tissue for the purpose of characterizing fracture healing. Two structural embodiments of such a medical device are contemplated, in which the sensor components of the sensor system 2229 are included in a single medical device, and in another, the sensor components are located on multiple different structures of the medical device.

[0199] refer to Figure 24A and Figure 24B In a first embodiment, a plurality of sensing electrodes 2420 are associated with a single medical device 2400 having a structure configured for implantation in bone 2410 to bridge fracture 2408. In this embodiment, the length of the medical device 2400 is selected such that a first sensing electrode 2428 can be positioned on a first side of fracture 2408, and a second sensing electrode 2430 can be positioned on a second side of fracture opposite to the first side.

[0200] refer to Figure 24CIn a second embodiment, a first sensing electrode 2428 of the medical device 2400 is associated with a first implant or structure 2402 configured for implantation on a first side of a fracture 2408, and a second sensing electrode 2430 of the medical device is associated with a second implant or structure 2404 configured for implantation on a second side of a fracture. In this embodiment, the medical device 2400 includes a third implant or plate 2406 configured to span structures 2402 and 2404. The plate 2406 serves as a means of electrically coupling the two sensing electrodes 2428 and 2430 to a common sensing assembly. The common sensing assembly may be included in one or more of the first structure 2402, the second structure 2404, and the plate 2406.

[0201] In any embodiment, impedance measurements of the fracture 2408 across the bone can be acquired and analyzed over time as a means of monitoring the healing process from the inflammatory phase to the repair phase, for example, from hematoma to callus, as it transforms into bony callus / cavernous bone. For this purpose, the medical device 2400 can acquire changes in impedance measurements as a function of time. The measurements can be acquired periodically, for example, once per hour, once every 6 hours, etc., to collect a dataset of impedance measurements changing over time. In some embodiments, the dataset of impedance measurements is analyzed on-site by the medical device 2400 to provide results depicting the fracture healing status. In some embodiments, the dataset is communicated to an external device for analysis to provide results depicting the fracture healing status.

[0202] In either case, such a description may include one of the following: “healed” (meaning that the fracture 2408 has healed, for example, the impedance amplitude across the fracture has increased to exceed the baseline threshold by a number, such as percentile), “suspected non-healing” (meaning that healing has not progressed at a level corresponding to healing, for example, the impedance amplitude across the fracture is increasing relative to the baseline, but the increase is too small and the rate of increase as a function of time is too slow), or “non-healing” (meaning that healing has not occurred, for example, the impedance amplitude across the fracture remains constant over time).

[0203] In some implementations, the results of the analysis are obtained by comparing measurements obtained from a patient impedance measurement dataset with similar measurements obtained from a reference dataset of impedance measurements from the entire patient population. For example, measurements of impedance changes over a period of time derived from the patient dataset can be compared with measurements of impedance changes over the same period of time derived from the reference dataset to determine whether the patient's measurement is within the acceptable range of the reference measurement. If the patient's measurement is determined to be outside the acceptable range, the smart medical device 2400 can issue an alarm. For example, an alarm may be issued if the patient's measurement differs from the reference measurement by a threshold standard, such as being a smaller percentile than the reference measurement.

[0204] In some implementations, measurements corresponding to different stages or modalities of bone healing over time can be established based on a reference dataset. For example, reference... Figure 23 The reference dataset can be established based on the expected changes in impedance on day 7 post-implantation, indicating the "cartilage" healing status; the expected changes in impedance on day 13 post-implantation, indicating the "C and C" healing status, where "C and C" represent cartilage and cancellous tissue; the expected changes in impedance on day 19 post-implantation, indicating the "cancellous tissue" healing status; and the expected changes in impedance on day 28 post-implantation, indicating the "cortical" healing status. Patient measurements at similar post-implantation times can be compared to reference measurements to track patient healing status and issue alerts when patient measurements exceed the acceptable range of the corresponding reference measurements.

[0205] Regarding obtaining impedance measurements, refer to... Figure 22B As previously mentioned, impedance sensor 2229 can be used as an EIS sensor. For this purpose, in some embodiments, impedance sensor 2229 employs a two-point impedance sensing method, and sensing electrode 2221 includes a first electrode and a second electrode. The first and second electrodes can be selected from a plurality of available sensing electrodes 2231a-2231n. Sensing circuitry / module 2227 is configured to enable the first and second electrodes to function in either an application mode or a sensing mode. During application mode, a signal, such as a current, is applied across the first and second electrodes. For example, a signal can be applied to the first electrode while the second electrode is grounded. During sensing mode, the impedance between the first and second electrodes is sensed based on the potential change between the electrodes.

[0206] Regarding application modes, in some implementations, signal generator 2235 generates a digital representation 2245 of a time-sine curve at a first frequency and provides this sinusoidal signal to DAC 2239 and impedance calculator 2237. DAC 2239 receives the digital representation 2245, converts it into an analog sinusoidal voltage 2247, and provides it to GMC 2241. GMC 2241 converts the analog sinusoidal voltage 2247 into a sinusoidal current 2249. GMC 2241 outputs the sinusoidal current 2249 to electrode switch 2223, which in turn applies the sinusoidal current to the first electrodes 2231a-2231n of sensing electrodes 2221. The sinusoidal current 2249 is applied to body tissue through the different voltage potential between the first and second electrodes 2231a-2231n of the grounded sensing electrodes 2221.

[0207] During sensing mode, ADC 2243 senses a voltage 2251 across the first and second electrodes and through body tissue. ADC 2243 has an input coupled to the first electrode via electrode switch 2223. ADC 2243 converts voltage 2251 into a digital voltage 2253 and provides the voltage to signal generator 2235. Signal generator converts digital voltage 2253 into a digital sinusoidal voltage 2255 and provides it to impedance calculator 2237. Impedance calculator 2237 calculates impedance based on a digital representation 2245 of a time sine curve at a first frequency and the resulting digital sinusoidal voltage 2255.

[0208] The foregoing can be repeated for different frequencies within a range. Different impedance measurements at different frequencies allow for the collection of various measurements that may represent different fracture healing responses. Analysis of measurements at different frequencies can best reveal the correlation between impedance evolution at a specific frequency or subset of frequencies and the healing stage. For each frequency, the impedance calculator 2237 processes the corresponding digital representation 2245 of the time-sine curve and the digital sinusoidal voltage 2255 to calculate the complex impedance (Z) of the anatomical structure. As described above, these impedances are collected into a dataset over time and analyzed to provide results corresponding to the fracture healing state.

[0209] Regarding obtaining impedance measurements, please refer to [link / reference]. Figure 22B In some embodiments, impedance sensor 2229 employs a four-point impedance sensing method, and sensing electrodes 2221 include a first electrode, a second electrode, a third electrode, and a fourth electrode that are switchably coupled to the sensing module via electrode switch 2223. The first and second electrodes can be selected from a plurality of available sensing electrodes 2231a-2231n. Sensing circuitry / module 2227 is configured to enable the first and second electrodes to function in an application mode, and the third and fourth electrodes to function in a sensing mode. During application mode, a signal, such as a current, is applied across the first and second electrodes. For example, a signal can be applied to the first electrode while the second electrode is grounded. During sensing mode, the impedance between the third and fourth electrodes is sensed based on the potential between the third and fourth electrodes.

[0210] In some implementations, changes in impedance indicate healing progress. For example, reference Figure 23Figure 2300 shows the impedance amplitude 2302 across the fracture as a function of time 2304, measured using a pair of sensing electrodes spaced 27 mm apart and based on EIS measurements at a frequency of 5000 Hz. Progression of different fracture characteristics or healing states, including cartilage, cartilage and cancellous tissue (C and C), and cancellous tissue and cortex, is represented by the corresponding increase in impedance amplitude between day 5 and day 35. In this example, given the increase in impedance amplitude over time, the data analysis result on day 35 would indicate "healing" (meaning fracture healing).

[0211] The impedance sensor 2229 of the intelligent medical device 2400 offers a variety of benefits superior to other methods of monitoring bone healing. For example, the monitoring capability of the medical device 2400 eliminates the need for intermediate X-ray imaging, which reduces healthcare costs and the inconvenience of patients having to travel to imaging facilities. In cases of suspected nonunion, the monitoring capability of the medical device 2400 identifies slow healing earlier than imaging monitoring and allows for additional patient care and complementary and / or alternative treatment options. In cases of nonunion, the monitoring capability of the medical device 2400 identifies nonunion fractures earlier than imaging monitoring, thus allowing for consideration of other options for the patient, such as new surgeries, such as hip replacement. The medical device 2400 also provides improved workflows for clinical medical practitioners by providing useful information relatively automatically and by providing relevant remote patient monitoring (RPM) data for a period of time when minimum reimbursement requirements may be met.

[0212] refer to Figure 22A , Figure 22B and Figure 24B Considering an implementation of a smart medical device in which the sensor components of sensor system 2229 are included in a single medical device, in a particular configuration, medical device 2400 may have multiple electrodes 2420 along its axis. In this configuration, switch controller 2234 may be configured to control electrode switch 2223 to select a first electrode 2428 and a second electrode 2430 from the multiple electrodes 2420 by testing various electrode pairs: first, determining the location of fracture 2408; second, selecting an electrode on the first side 2460 of the fracture as the first electrode 2428 and an electrode on the second side 2462 of the fracture as the second electrode 2430.

[0213] The location of a fracture can be determined by obtaining impedance measurements between adjacent electrode pairs along the axis of the medical device 2400 until a measurement indicating a fracture is obtained. For example, it can be determined that fracture 2408 is located between electrode pairs with the highest impedance measurements. Regarding the selection of the first electrode 2428 and the second electrode 2430, although any electrode on either side can be selected, closely spaced electrodes tend to provide more accurate impedance measurements. Therefore, as a general rule, the electrode closest to fracture 2408 but on its opposite side is selected as the first electrode 2428 and the second electrode 2430.

[0214] Initial electrode selection can occur during implantation of the medical device via a physician interface, such as a programmer, configured to detect the fracture location relative to the electrode pair based on impedance measurements. For this purpose, an external programmer can control the implanted switch controller 2234 to implement the aforementioned electrode selection process.

[0215] Continue to refer to Figure 22A , 22B In another configuration of a smart medical device, where the sensor components of sensor system 2229 are included in a single medical device, medical device 2400 may further include a third electrode 2448 and a fourth electrode 2450 at the outer surface of 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 the signal generator to enable an application mode during which a signal, such as a current, is applied across the first and second electrodes. The third electrode 2448 and the fourth electrode 2450 are coupled to the impedance sensor to enable a sensing mode during which the voltage potential between the third and fourth electrodes is measured, and the impedance is calculated based on the current applied across the first and second electrodes.

[0216] refer to Figure 22A , Figure 22B and Figure 24C Considering an implementation of a smart medical device, in which sensor assemblies are located on multiple different structures of the medical device, in one particular configuration, the medical device 2400 includes a first structure 2402 configured to be at least partially implanted in bone 2410, the first structure having at least one first electrode 2428, a second structure 2404 configured to be at least partially implanted in bone, the second structure having at least one second electrode 2430, and a third implant or structure 2406 configured to be placed across a fracture 2408 on the bone and secured 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 measure tissue impedance between the first electrode 2428 and the second electrode 2430.

[0217] refer to Figure 22A Furthermore, as described above, in some embodiments, IRP 2203 may include one or more sensors 2222 other than impedance sensor 2229. Representative examples of other sensors 2222 suitable for use within IRP 2203 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, conductivity sensors, optical sensors, acoustic sensors, accelerometers, gyroscopes, mechanical stress sensors, and temperature sensors.

[0218] A wide variety of sensors (also known as microelectromechanical systems or "MEMS", or nanoelectromechanical systems or "NEMS", and BioMEMS or BioNEMS, generally see https: / / en.wikipedia.org / wiki / MEMS) can be utilized. Representative patents and patent applications include U.S. Patents Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267 and 8,634,928, and U.S. Publications Nos. 2010 / 0285082 and 2013 / 0215979. Representative publications include Albert Foch's "Introduction to BioMEMS", CRC Press, 2013; Marc J. Madou's "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications, CRC Press 2011; Simona Badilescu's "Bio-MEMS: Science and Engineering Perspectives, CRC Press 2011; Steven S. Saliterman's "Fundamentals" ofBioMEMS and Medical Microdevices", SPIE-The International Society of OpticalEngineering, 2006; "Bio-MEMS: Technologies and Applications", edited by Wanjun Wang and Steven A. Soper, CRC Press, 2012; and Volker Kempe's "Inertial MEMS: Principles and Practice", Cambridge University Press, 2011; Polla, DL, et al., "Microdevices in Medicine," Ann.Rev.Biomed.Eng.2000,02:551-576; Yun, KS, et al., "A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations," J.Microelectromechanical Sys., 11:5, October 2002, 454-461; Yeh, R., et al."SingleMask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors," J. Microelectromechanical Sys., 11:4, August 2002, 330-336; and Loh, NC, et al., "Sub-10cm³ Interferometric Accelerometer with Nano-g Resolution," J. Microelectromechanical Sys., 11:3, June 2002, 182-187; all of the above references are incorporated herein by reference in their entirety.

[0219] Sensor 2222 may be located on a printed circuit board of electronic assembly 2210, or in or on another structure of the intelligent medical device that is separate from IRP 2203 but electrically coupled to the electronic assembly. In some embodiments, sensor 2222 may include a processor or a processor that can be coupled to a printed circuit board located on electronic assembly 2210. In other embodiments, the sensor may be a wireless sensor. In other embodiments, one or more (including all) sensors may have a unique sensor identification (USI) number that specifically identifies the sensor.

[0220] Sensor 2222 can be an ultrasound sensor used to characterize fracture healing based on known ultrasound techniques. For this purpose, an ultrasound sensor with suitable size and power requirements that can be supported by a medical device can be located within the structure of the medical device, for example, in a hollow screw or electronic box, which, after implantation, places the sensor at or near the fracture site. Ultrasound measurements of the tissue at the fracture site can be acquired over time and processed to provide one or more of the fracture characterization and tissue characterization in the structural region.

[0221] Sensor 2222 can be a stress sensor used to characterize fracture healing based on known mechanical stress / stress techniques. For this purpose, the stress sensor can be located within the structure of a medical device, such as a hollow screw or electronic box, which, after implantation, places the sensor at or near the fracture site. Stress measurements at the fracture site can be obtained over time and processed to provide one or more of the fracture characterization and tissue characterization within the structural region.

[0222] Sensor 2222 can be a glucose detector or an oxygen sensor used to characterize tissue inflammation based on known techniques. For this purpose, the glucose detector or oxygen sensor can be located within the structure of a medical device, such as a hollow screw or electronic box, which, after implantation, places the sensor at or near the fracture site. Sensor measurements at the fracture site can be obtained over time and processed using known techniques to provide indications of inflammatory fluids, interstitial fluids, or other biological fluids, such as blood, in the device area.

[0223] Sensor 2222 can be used to detect, measure, and / or monitor information related to the status of the implanted device. The status of the device may include the integrity of the device (device breakage), the movement of the device (device withdrawal), the forces applied to the device, and other information related to the implanted device. Examples of these types of sensors 2222 include gyroscopes, accelerometers, and temperature and pressure sensors.

[0224] Sensor 2222 can be used to detect, measure, and / or monitor information related to the state of the body or body segment after device implantation. The state of the body or body segment may include kinematic information of the body or body segment. Examples of these types of sensors 2222 include gyroscopes, accelerometers, and temperature and pressure sensors coupled to a processor. In some embodiments, sensor 2222 is an inertial measurement unit (IMU), such as an accelerometer or gyroscope, configured to output signals corresponding to the motion of the medical device 100, and, by association, output signals corresponding to the motion of the bone structure of the implanted device, and the motion or activity of the patient with the implanted device.

[0225] Sensor 2222 can be used to detect, measure, and / or monitor information related to body tissues after device implantation. 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 liquids). Sensor 2222 can be used to monitor temperature in the device area for infection detection purposes.

[0226] Energy source 2212 is configured to generate a regulated energy source signal in the range of approximately 1–24 volts (V) to power the components of IRP2203. Energy source 2212 may include one or more of a battery, a rechargeable energy source device (e.g., a rechargeable battery or supercapacitor), and an energy harvester.

[0227] In some implementations, the energy source 2212 of IRP 2203 can be any suitable battery, such as a lithium fluoride (LiCFx) battery, or other storage unit configured to store energy for powering components of electronic assembly 2210 for the expected lifespan (e.g., 5–25+ years) of the smart medical device.

[0228] The size of the energy source 2212 is typically limited by the structure of the medical device, such as the dimensions of hollow screws or the electronic housing. For example, see reference... Figure 13C and 13D The diameter of the energy source 1354 is limited by the diameter of the inner cavity 1304 of the hollow screw 1302. In another example, refer to... Figures 17A to 17C The diameter of energy source 1754 is limited by the diameter of shaft 1726 of electron box 1706. In yet another example, see reference... Figure 19A and 19B The diameter of the energy source 1954 is limited by the diameter of the lower cavity of structure 1902. In the exemplary design, the diameter of the battery can be greater than 1 mm and is typically in the range of 1 mm to 5 mm. The length of the battery can be greater than 1 mm and is at least 3 mm. The volume of the battery can be greater than 2 mm. 2 The battery capacity can be greater than 1mAh, but more energy may be required for measurement and communication, such as around 100mAh. The power required to fully charge the battery in one hour may be greater than 5mW, and is generally in the range of 5mW to 150mW.

[0229] In some implementations, the energy source 2212 of the IRP 2203 can be a supercapacitor. Supercapacitors are attractive due to their rapid charge / discharge characteristics; for example, a 2.8mAh battery is rated for a 0.2C charge / discharge -> 5-hour charging time. They also have increased current delivery capabilities compared to batteries. The supercapacitor can be an electrochemical double-layer capacitor (EDLC) supercapacitor or a linear supercapacitor. Commercially available EDLCs have only half the volumetric energy density of "advanced" linear supercapacitors. Therefore, linear supercapacitors are likely preferred.

[0230] Exemplary characteristics and specifications of linear supercapacitors include: shape factor (2 x 0.5 mm OD line), 153.3 Wh / kg. -1 Its gravimetric energy density (1 / 3 of LiCFx), 8810 W / kg -1 The power density is 20 times that of LiCFx. Example characteristics and specifications of EDLCs include form factor (3.2 x 2.5 x 0.9 mm), single-digit μAh, and 2.3 mWh / cm². -3 .

[0231] In some implementations, the energy source 2212 of the IRP 2203 can be a hybrid solution. In this configuration, the IRP includes a first energy source for measurement, such as a main battery, and a second energy source for temporarily buffering energy during data exchange, such as a supercapacitor.

[0232] The energy source 2212 of the IRP 2203 can be a rechargeable energy source device, such as a lithium-ion battery or a supercapacitor. In this case, the energy source 2212 and / or the electronic assembly 2210 include additional components for charging the energy source via an external charging unit. These additional components may include power coils configured to generate voltage and current in response to a magnetic field generated by the external recharging unit. Possible energy transfer modes include far-field RF, near-field RF, and ultrasound.

[0233] In an exemplary configuration for far-field RF power transfer, the operating parameters include: power: 0.24 / 32mW, frequency: 2.34 / 1GHz, efficiency: 12 / 0.2%, and antenna size: 9 / 2160mm. 2 The range is 20 / 150cm, and the permissible specific absorptivity (SAR) limit (1.6W / kg) restricts power transfer. Far-field power transfer can be guided using multiple antennas. Furthermore, far-field power transfer can be achieved using antennas designed for communication. For example, Figure 9B The antenna 144b can be used for RF power transfer and RF communication.

[0234] In an exemplary configuration for near-field RF power transfer, operating parameters include: power: 0.2 / 15.7mW, frequency: 10MHz / 1.5GHz, efficiency: 15.2 / 0.5%, antenna size: 2.3 / 6mm², and depth: 0.5 / 3cm. Near-field power transfer involves precise adjustment and alignment, as well as close contact with the skin.

[0235] In an exemplary configuration for ultrasound energy delivery, operating parameters include: power: 0.36 mW @ 1 MHz, efficiency up to 5.6%, transducer size: 1 x 1 mm², depth: minimum 5 mm or greater, relating to the maximum thickness for individuals with a BMI (Body Mass Index) up to 45. In this configuration, energy may be delivered at tissue depths greater than 10 cm. Ultrasound energy delivery may become less efficient when traversing various tissue types and involves direct contact with the skin.

[0236] The energy harvester is configured to convert environmental stimuli into energy for charging a rechargeable power device. For example, the harvester can convert one or more of the following into battery charging current or voltage or supercapacitor charging: body heat from the object implanted with the IRP 2203, kinetic energy generated by the object's movement, pressure changes (e.g., air pressure or pressure within the object, such as the object's blood pressure), energy generated by electrochemical reactions in the object's body, energy generated by a radio frequency (RF) field, light, electromechanical conversion (such as piezoelectricity), or electromagnetic conversion.

[0237] Fuse 2214 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent injury to the patient and damage to one or more components of the battery and electronic assembly 2210 from the energy source 2212 or current flowing from the battery. For example, fuse 2214 can be configured to prevent the energy source 2212 from generating sufficient heat to burn the patient, damage the electronic assembly 2210, damage the battery, or damage structural components of the smart implant.

[0238] The first power source switch 2216 is configured to couple the power source 2212 to 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 with an open state that causes the switch 2216 to open during sleep mode or other low-power modes, thus disconnecting the power source from one or more sensors 2222 to save power and, consequently, extend the lifespan of the power source 2212. Similarly, the controller 2232 may also be configured to generate a control signal with a closed state that causes the switch 2216 to close upon “waking” from sleep mode or otherwise exiting another low-power mode, thus coupling the power source to one or more sensors 2222. This low-power mode may be used only for one or more sensors 2222 or for one or more other components of the sensor and electronics assembly 2210.

[0239] The second power source switch 2218 is configured to couple the power source 2212 to 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 with an on state during sleep mode or other low-power modes, causing the switch 2218 to open and thus disconnecting the power source from the memory 2224 to save power and thus extend the lifespan of the power source 2212. Similarly, the controller 2232 may also be configured to generate a control signal with a closed state upon waking from sleep or otherwise exiting another low-power mode, causing the switch 2218 to close and thus coupling the power source to the memory 2224. This low-power mode may be used only for the memory 2224 or for one or more other components of the memory and electronic assembly 2210.

[0240] The clock and power source management unit 2220 can be configured to generate clock signals for one or more other components of the electronic assembly 2210, and can be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to which the controller 2232 can cause one or more components of the IRP 2203 to enter or exit sleep or other low-power modes. The clock and power source management unit 2220 can also be configured to regulate the voltage from the power source 2212 and provide regulated power source voltages to some or all other components of the electronic assembly 2210.

[0241] Memory 2224 may include volatile and non-volatile memory. For example, volatile memory may be configured to store the operating system and one or more applications executed by controller 2232. Non-volatile memory may be configured to store configuration information of IRP 2203 and data written by controller 2232, and provide data in response to read commands from the controller.

[0242] The IRP 2203 for the medical device includes a communication interface that facilitates communication between the medical device and another device. For example, the other device can be an external device, such as a base station, located outside or away from the patient receiving the medical device, or it can be an internal device located within the patient receiving the medical device. In either case, communication between the implanted medical device and another device, whether internal or external, is referred to as in vivo communication. The communication interface of the IRP 2203 can enable one or more in vivo communication modes. As previously disclosed, possible modes of in vivo communication include: 1) RF telemetry communication, 2) tissue conduction communication, such as current-coupled communication, and 3) sound data communication, such as ultrasound or acoustic communication.

[0243] The communication interface includes communication circuitry 2225, which is typically, but not necessarily, associated with the electronic assembly 2210 of IRP 2203. Communication circuitry 2225 may include any hardware, firmware, software, or any combination thereof suitable for enabling one or more in-body communication modes. For this purpose, communication circuitry 2225 may include, for example, voltage regulators, current generators, oscillators or circuitry for generating signals, resistors, capacitors, inductors, and other filtering circuitry for processing received signals, as well as circuitry for modulating and / or demodulating signals according to a communication protocol.

[0244] Depending on the mode of in vivo communication, the communication circuit 2225 may also include transistors or other switching circuits for selectively coupling with or receiving signals from desired transceivers, such as antenna 2230 (which can be used for electromagnetic communication, such as RF telemetry communication), electrodes 2231, 2233 (which can be used for tissue conduction communication), or acoustic transducer 2236 (which can be used for voice data communication). Under the control of controller 2232, the communication circuit 2225 can receive downlink communication signals from an external device or another implanted device, and send uplink communication signals to it. Additionally, the communication circuit 2225 can communicate with networked computing devices, such as the Medtronic CareLink® Network developed by Medtronic, plc, Dublin, Ireland, via external devices and computer networks.

[0245] Additional details regarding each of the following modes of intracellular communication: RF telemetry communication, tissue conduction communication, and voice data communication.

[0246] The RF telemetry mode for in-vivo communication is enabled by an RF communication interface, which includes an antenna 2230 and RF telemetry circuitry, 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 can be a conventional transceiver configured to allow the controller 2232 (and optionally a fuse 2214) to communicate with another implanted medical device ( Figure 22A (not shown in the image) or with a base station configured for use with a smart implantable device ( Figure 22A (Not shown in the image) Communication. For example, RF transceiver 2226 can be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE)) and It can be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE) and...). It can operate and can be configured to run within a frequency band ranging from 1MHz to 5.4GHz or any other suitable range. In an exemplary configuration of far-field RF communication, the frequency band can be 401-406MHz or 2.4GHz. Depending on some implementations, different frequencies can be used for different purposes. For example, in one configuration, 2.4GHz can be used to wake up the device, while 400MHz is used for communication.

[0247] In the case of far-field RF communication, antenna 2230 can be a monopole, dipole, folded dipole, zigzag-loaded, loop, small loop, on-chip MEMS, or helical antenna. Furthermore, antennas used for power transfer can be used to implement far-field RF communication. For example, Figure 9B The antenna 144b can be used for RF power transfer and RF communication.

[0248] Filter 2228 can be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. Antenna 2230 can be in a frequency band suitable for the RF transceiver 2226 to generate signals for antenna transmission and for the base station ( Figure 22A (Not shown) Any antenna in the frequency band that generates a signal for the antenna to receive.

[0249] In vivo tissue conduction communication (TCC) mode is enabled by a TCC interface including TCC circuitry 2238 and a pair of electrodes 2231, 2233. The electrode pair 2231, 2233 may be selected from sensing electrode 2221 and coupled to TCC circuitry 2238 via electrode switch 2223. Optionally, this pair of electrodes may be electrodes 2231, 2233 serving as sensing electrode 2221. The TCC interface allows controller 2232 to communicate with another device that has the same TCC interface as IRP 2203. This other device may be an implanted medical device (…). Figure 22A (not shown in the image), or a base station configured for use with a medical device ( Figure 22A (Not shown in the image).

[0250] Tissue-conductive communication relies on the ion content of the patient's body tissue in which the smart medical device 2202 is implanted, and is therefore often referred to as electrical communication. The ion content of the body tissue provides an electrical communication medium through which information is sent to and received from the smart medical device. For communication in transmit mode, the TCC circuit 2238 applies a voltage across electrodes 2231, 2233, causing current to flow between the electrodes and the corresponding electrical signal to propagate through the body tissue. This can be achieved via a receiving device (…). Figure 22A (Not shown) The propagation current is detected by measuring the voltage generated between the two electrodes. In order to communicate in receive mode, the TCC circuit 2238 measures the voltage across electrodes 2231 and 2233.

[0251] When tissue conduction communication is employed to facilitate communication, the sensing accessory and other means of receiving and / or sending information to the sensing accessory have associated hardware, firmware, software, or any combination thereof suitable for providing such communication. TCC transmission and associated hardware, firmware, and software have been described and can be included in the smart implantable devices disclosed herein. See, for example, U.S. Patent Publications Nos. US2016213939, US2018207429, US2019160290, US2019160291, US2019160292, and US2019184181. For example, in one aspect, TCC circuitry 2238 may be coupled to one or more electrodes 2231, 2233 and configured with circuitry enabling the TCC interface to switch between a transmission mode for transmitting TCC signals and a reception mode for receiving TCC signals from another similarly configured device.

[0252] The in-vivo communication audio data mode is enabled by an audio data communication interface including audio data circuitry 2240 and at least one acoustic transducer 2236. The audio data communication interface allows the controller 2232 to communicate with another device having the same audio data communication interface as IRP 2203. This other device may be an implantable medical device or a base station configured for use with a smart implantable device.

[0253] When voice data communication is employed to facilitate communication, the intelligent medical device and other means of receiving and / or sending information to the intelligent implantable device have relevant hardware, firmware, software, or any combination thereof suitable for providing such communication. Voice data communication transmission and related hardware, firmware, and software have been described and may be included in the intelligent medical devices disclosed herein. See, for example, U.S. Patent Nos. 7,489,967, 2010,024,988,2A1, and 2013,003,396,6A1. For example, in one aspect, voice data circuitry 2240 may be coupled to acoustic transducer 2236 and configured with circuitry enabling the voice data communication interface to switch between a transmission mode for transmitting ultrasound signals and a reception mode for receiving ultrasound signals from another similarly configured device.

[0254] The controller 2232, which can be any suitable microcontroller or microprocessor, 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 sense relevant measurement data to store the measurement data generated by the one or more sensors in memory 2224. The controller 2232 is also configured to generate messages for communication over one or more types of communication interfaces. For example, in the case of RF telemetry communication, the controller 2232 generates a message including data stored as a payload, packages the message, and provides the message packet to the RF transceiver 2226 for transmission to a base station. Figure 22A (Not shown in the image). Controller 2232 can also be configured to perform operations from a base station via a communication interface, such as antenna 2230, filter 2228, and RF transceiver 2226. Figure 22A Commands received (not shown). For example, controller 2232 can be configured to receive configuration data from a base station and provide the configuration data to components of electronic assembly 2210, to which the base station directs the configuration data. If the base station directs the configuration data to controller 2232, the controller is configured to configure itself in response to the configuration data.

[0255] On the one hand, the medical device of this disclosure is sterile. On the other hand, the medical device of this disclosure has undergone sterilization procedures to provide a sterile medical device. Among various options, alcohol solutions can be used to sterilize the medical device by exposing it to ethylene oxide, ionizing radiation, autoclaving, ultraviolet radiation, or drying heat. Alcohol solutions that can be used include, but are not limited to, methanol, ethanol, isopropanol, and aqueous solutions thereof. The ionizing radiation used can include gamma radiation and electron beam radiation. The ionizing radiation dose used for sterilization is greater than 20 kGy, greater than 25 kGy, greater than 30 kGy, greater than 35 kGy, or greater than 40 kGy. For devices sterilized using ethylene oxide, the sterilized device preferably meets the residual ethylene oxide and vinyl chloride levels of ISO 10993-7.

[0256] The medical device disclosed herein can be in a non-sterile form. On the one hand, non-sterile medical devices comply with USP... <1111> The requirements are as follows: On the one hand, non-sterile devices have a total aerobic microbial count of 10² or less (cfu / g or cfu / mL). On the other hand, non-sterile devices have a total combined yeast / mold count of 10¹ or less (cfu / g or cfu / mL). On the other hand, non-sterile devices have a total aerobic microbial count of 10² or less (cfu / g or cfu / mL) and a total combined yeast / mold count of 10¹ or less (cfu / g or cfu / mL). Non-sterile contraceptive devices must not be contaminated with Pseudomonas aeruginosa, Staphylococcus aureus, or Candida albicans.

[0257] Implantation site

[0258] refer to Figure 24A and Figure 24B In some embodiments, the structure 2402 of the medical device 2400 is configured to be implanted to bridge the fracture 2408 of the bone 2410. For example, in Figure 24A In this context, medical device 2400 can be one of two devices arranged parallel to each other to bridge the femoral neck fracture 2408. In another example, such as Figure 24B As shown, medical device 2400 can be one of three devices implanted to form a triangle and bridge the femoral head hip fracture 2408, the other two devices 2422 and 2424 being simply cannulated screws. In this example, medical device 2400 is implanted at the location with the least load among the three positions at the apex of the triangle. In another embodiment, medical device 2400 can be implanted solely for the purpose of monitoring bone healing and does not provide any support or load-bearing function related to orthopedic treatment provided by other devices. For this purpose, medical device 2400 can be implanted at the center of the surrounding orthopedic support device, for example, at the center of the triangle, where the orthopedic support device is implanted at each apex of the triangle.

[0259] refer to Figure 24C In some implementations, the medical device 2400 includes a pair of smart structures 2402, 2404, each smart structure being configured to be implanted through a corresponding hole in a plate 2406 that bridges a fracture 2408 of bone 2410, such as a fracture of the humeral shaft.

[0260] refer to Figure 24D and Figure 24E In some embodiments, the medical device 2400 is a structure 2402, such as a rod or pin, configured to be implanted to bridge the fracture 2408 of the bone 2410. For example, in Figure 24D In the medical device 2400, structure 2402 is a push rod bridging a distal fibular fracture. Figure 24E In the medical device 2400, structure 2402 is one of the four percutaneous pins for bridging cervical and humeral fractures.

[0261] Fracture characterization devices and methods

[0262] Figure 25A and Figure 25B The diagrams shown are a flowchart and a schematic diagram of a method for characterizing fractures. This method can be executed by one of the intelligent medical devices disclosed herein and further configured as follows.

[0263] At frame 2502, a smart medical device 2520 having multiple electrodes is implanted into bone tissue 2522 to position a first electrode 2524 and a second electrode 2526 on opposite sides of a fracture 2528. In some methods, multiple electrodes are implanted by inserting a cannula structure having a lumen into the bone tissue and through the fracture. After implantation of the cannula structure, an electronic cartridge with a sensing module and other electronics is inserted into the lumen. In some methods, the cannula structure includes multiple electrodes, and the electrodes are coupled to the sensing module when the electronic cartridge is inserted into the lumen. In some methods, multiple electrodes are included in the electronic cartridge and engage with the bone tissue through holes in the sidewalls of the cannula structure or through openings at the ends of the cannula structure. In some methods, multiple electrodes are implanted by implanting a pre-loaded medical device having a structure including multiple electrodes, a sensing module, and other electronics coupled to the multiple electrodes.

[0264] At frame 2504, multiple measurements of the electrical properties of the tissue are obtained over time using a first electrode 2524 and a second electrode 2526 located on opposite sides of the fracture 2528. The electrical properties of the tissue can correspond to impedance measurements, and these measurements are obtained by applying signals of different frequencies to the first electrode 2524 to measure tissue impedance according to EIS technology.

[0265] At box 2506, processing measurements are performed to determine the characteristics of fracture 2528, which correspond to the healing status of the fracture, such as healed, possibly non-healed, and non-unioned.

[0266] At box 2508, multiple measurements of the electrical properties of the tissue or the characterization of fracture 2528 are communicated to an external device.

[0267] Figure 26A and Figure 26B The diagrams shown are a flowchart and a schematic diagram of a method for characterizing fractures. This method can be executed by one of the intelligent medical devices disclosed herein and further configured as follows.

[0268] At frame 2602, a smart medical device 2620 having multiple electrodes is implanted into bone 2622 to place each of the first electrode 2624 and the second electrode 2626 within the gap 2630 of the fracture 2628. In some methods, multiple electrodes are implanted by inserting a cannula structure having a lumen into the bone tissue at the fracture site. After implantation of the cannula structure, an electronic cartridge with a sensing module and other electronics is inserted into the lumen. In some methods, the cannula structure includes multiple electrodes, and the electrodes are coupled to the sensing module when the electronic cartridge is inserted into the lumen. In some methods, multiple electrodes are included in the electronic cartridge and engage with bone tissue through holes in the sidewalls of the cannula structure. In some methods, multiple electrodes are implanted by implanting a pre-loaded medical device having a structure including multiple electrodes, a sensing module, and other electronics coupled to the multiple electrodes.

[0269] At frame 2604, multiple measurements of the electrical properties of the tissue are obtained over time using a first electrode 2624 and a second electrode 2626 within the gap 2630 of the fracture 2628. The electrical properties of the tissue can correspond to impedance measurements, and these measurements are obtained by applying signals of different frequencies to the first electrode 2624 to measure the tissue impedance according to EIS technology.

[0270] At box 2606, processing measurements are performed to determine the characteristics of fracture 2628, which correspond to the healing status of the fracture, such as healed, possibly non-union, and non-union.

[0271] At box 2608, multiple measurements of the electrical properties of the tissue or the characterization of fracture 2628 are communicated to an external device.

[0272] refer to Figure 26B The intelligent medical device 2620 includes a first set of electrodes on a first side of an axis 2632 of the medical device and a second set of electrodes spaced apart from the first side on a second side of the axis. This embodiment of the medical device can be based on, for example... Figure 21A and 21B The implementation plan was modified to include two sets of four pin electrodes. Continue. Figure 26BA smart medical device 2620 is placed in the patient's bone 2622 such that a first set of electrodes and a second set of electrodes span the fracture 2628, with at least one electrode in each set within a gap 2630. The electrodes are positioned on an axis 2632 such that a first electrode 2624 is on one side of the axis and a second electrode 2626 is on the other side. The axis 2632 may be insulated (e.g., anodized titanium). This creates an electrical path 2634 from the first electrode 2624 to the second electrode 2626 through the healing bone in the gap 2630. This provides a high impedance change as the fracture site heals. However, the electrical path 2634 may be located in an area immediately surrounding the axis 2632. Therefore, to better understand healing over the entire fracture site, multiple medical devices 2620a, 2620b, 2620c of this type can be used to place multiple pairs of electrodes within the gap 2630 at multiple locations across the gap cross-section, thereby collecting multiple sets of impedance measurements at different locations within the gap.

[0273] Figure 27A and Figure 27B The diagrams shown are a flowchart and a schematic diagram of a method for characterizing fractures. This method can be executed by one or more intelligent medical devices disclosed herein and further configured as follows.

[0274] At frame 2702, a smart medical device 2720 having multiple electrodes is implanted into bone 2722 to place each of a first linear electrode 2724 and a second linear electrode 2726, such that each linear electrode spans the gap 2730 of the fracture 2728. The lengths of the linear electrodes 2724 and 2726 may be at least 1 mm. In some methods, multiple electrodes are implanted by inserting a cannula structure having a lumen into the bone tissue at the fracture site. After implantation of the cannula structure, an electronic cartridge with a sensing module and other electronic devices is inserted into the lumen. In some methods, the cannula structure includes multiple electrodes, and the electrodes are coupled to the sensing module when the electronic cartridge is inserted into the lumen. In some methods, multiple electrodes are included in the electronic cartridge and engage with bone tissue through slots in the sidewalls of the cannula structure. In some methods, multiple electrodes are implanted by implanting a preloaded medical device having a structure including multiple electrodes, a sensing module, and other electronic devices coupled to the multiple electrodes.

[0275] At frame 2704, multiple measurements of the electrical properties of the tissue are obtained over time via a first linear electrode 2724 and a second linear electrode 2726 spanning the gap 2730 of the fracture 2728. The electrical properties of the tissue can correspond to impedance measurements, and these measurements are obtained by applying signals of different frequencies to the first linear electrode 2724 to measure the tissue impedance according to EIS technology.

[0276] At box 2706, processing measurements are performed to determine the characteristics of fracture 2728, which correspond to the healing status of the fracture, such as healed, possibly non-healed, and non-unioned.

[0277] At box 2708, multiple measurements of the electrical properties of the tissue or the characterization of fracture 2728 are communicated to an external device.

[0278] refer to Figure 27A The intelligent medical device 2720 includes a first linear electrode 2724 on a first side of an axis 2732 of the medical device and a second linear electrode 2726 spaced apart from the first side on a second side of the axis. This embodiment of the medical device can be based on, for example... Figures 13A to 13D The original implementation was modified to include two linear electrodes, each configured to extend through corresponding slots on opposite sides of the cannulation structure. (Continued) Figure 27B The intelligent medical device 2720 is placed in the patient's bone 2722 such that a first linear electrode 2724 and a second linear electrode 2726 span the fracture 2628. The linear electrodes 2724 and 2726 are located on an axis 2732, such that the electrodes are on opposite sides of the axis. The axis 2632 may be insulated (e.g., anodized titanium). This creates a current path 2734 from the first linear electrode 2724 to the second linear electrode 2726 through a localized area around the axis 2732. Because the linear electrodes 2724 and 2726 contact the bone 2722 on either side of the fracture site, the current path 2734 passes through the healed bone of the fracture site and through the bone on either side of the fracture site.

[0279] An illustrative cyclic diagram showing the initial state 2729 of fracture 2728 and the healing state 2731 of fracture 2728 is presented. As bone heals, the impedance in the gap 2730 of fracture 2728 changes from a low resistance RG in the fracture state to a higher resistance RG' in the healing state, allowing the intelligent medical device 2720 to detect whether healing occurs in a localized area around shaft 2732. If two linear electrodes 2724, 2726 are placed on each side of shaft 2732, it is possible to use a 4-wire impedance measurement to eliminate the influence of electrode contact resistance from this measurement. This implementation tends to measure healing only in a localized area around shaft 2732. Therefore, to better understand healing across the entire fracture site, multiple medical devices of this type can be employed with linear electrode pairs at multiple locations across the gap 2730 at different locations in the gap, thereby collecting multiple sets of impedance measurements at different locations in the gap.

[0280] On one hand, this disclosure provides a method for treating fractures in bone tissue, wherein the method includes identifying the fracture in the bone tissue and inserting a medical device disclosed herein into the bone tissue, wherein the medical device is inserted through the fracture. The fracture can be identified, for example, by X-ray. In one embodiment, the medical device is a screw. The medical device can be inserted into the bone tissue according to standard techniques for inserting a hollow screw into bone with a fracture. Optionally, the method also includes characterizing the fracture with the medical device.

[0281] On one hand, this disclosure provides a method for characterizing fractures in bone tissue, the method comprising identifying the fracture in the bone tissue, inserting a medical device, as disclosed herein, into the bone tissue, wherein the medical device is inserted through the fracture; and characterizing the fracture using a sensor located in the medical device. The fracture can be identified, for example, by X-ray. In one embodiment, the medical device is a screw. The medical device can be inserted into the bone tissue according to standard techniques for inserting a hollow screw into bone with a fracture.

[0282] Communication with smart medical devices

[0283] A smart medical device can be part of an environment in which it communicates. An exemplary environment is an operating room, where a smart medical device is implanted in a patient by a healthcare professional. Another exemplary environment, where a smart medical device has been implanted in a patient, is the patient's home. Yet another exemplary environment is a healthcare professional's office, where a patient with an implanted smart medical device undergoes, for example, an evaluation. A detailed description of the exemplary environment of a patient's home is provided below. However, the described features and connectivity are similarly present in other environments where a patient with an implanted smart medical device resides, such as operating rooms and healthcare professional offices, as described herein, albeit in less detail.

[0284] Figure 28 A scope diagram of a smart medical device environment 2800 is shown, including features present in a patient's home. In this environment, a smart medical device 2802, including an implantable reporting processor (IRP) 2803, has been implanted in the patient (not shown). In summary, the sensing capabilities and associated electronic assemblies of the smart medical device of this disclosure may be referred to as an implantable reporting processor (IRP). An IRP is a component of the smart medical device of this disclosure, wherein the smart medical device includes an IRP. An antenna may or may not be a component of the IRP. Similarly, a power source may not be a component of the IRP. The implantable reporting processor 2803 is arranged and configured to collect data, including, for example, patient-related medical and health data associated with the device, 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 phases of patient monitoring.

[0285] The intelligent medical device 2802 includes one or more sensors that collect information and data, including patient-related medical and health data associated with the device, as well as operational data of the medical device 2802 itself. The intelligent medical device 2802 collects data at various times and rates during patient monitoring and may optionally store the data in memory until it is transferred outside the patient's body. In some embodiments, the intelligent medical device 2802 may operate in multiple different stages during patient monitoring, thereby collecting more data shortly after the intelligent medical device 2802 is implanted in the patient, but less data as the patient recovers and thereafter.

[0286] The amount and type of data collected by the smart medical device 2802 may vary from patient to patient, and the amount and type of data collected may change for an individual patient. For example, a medical practitioner studying data collected by the smart medical device 2802 for a specific patient may adjust or otherwise control how the smart medical device 2802 collects future data.

[0287] The amount and type of data collected by the intelligent medical device 2802 may vary depending on different body parts, different types of patient conditions, different patient demographics, or other differences. Optionally or additionally, the amount and type of data collected may vary over time based on other factors, such as the patient's recovery or well-being, the expected duration of the monitoring process, the remaining battery power in the intelligent medical device 2802 and what should be saved, the type of movement being monitored, the body part being monitored, etc. In some cases, the collected data is supplemented by personal descriptive information provided by the patient, such as subjective pain data, quality of life metrics, comorbidities, and the patient's perceptions or expectations associated with the intelligent medical device 2802.

[0288] Once the smart medical device 2802 is implanted in the patient and the patient returns home, the smart medical device can begin communicating outside the patient's body and within the home environment. It can communicate 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 and external smart devices, with the connected personal assistant also able to communicate with the smart medical device 2802. The smart medical device 2802 can collect data at a defined rate and time, a variable rate and time, or other controllable rates and times. Data collection can begin when the smart medical device 2802 is initialized in the operating room, under the guidance of a medical professional, or at a later point in time.

[0289] At least some 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 the base station and one or both of the connected personal assistant to the smart device, or via the smart device and one or both of the base station to the connected personal assistant. Here, "one or both" means via a single item, and via two items sequentially or in parallel. For example, data collected by the implanted smart medical device 2802 can be transmitted solely via the external smart device 2805, solely via the connected personal assistant 2807, sequentially via the external smart device and the connected personal assistant, sequentially via the connected personal assistant and the external smart device, and directly and possibly simultaneously via the external smart device and the connected personal assistant to the home base station 2804.

[0290] Similarly, data collected by the implanted smart medical device 2802 can be transmitted to an external smart device 2805 individually via a home base station 2804, individually via a connected personal assistant 2807, serially via a home base station and a connected personal assistant, serially via a connected personal assistant and a home base station, and directly and possibly simultaneously via a home base station and a connected personal assistant. Further, in this example, data collected by the implanted smart medical device 2802 can be transmitted to a connected personal assistant 2807 individually via an external smart device 2805, individually via a home base station 2804, serially via an external smart device and a home base station, serially via a home base station and an external smart device, and directly and possibly simultaneously via an external smart device and a home base station.

[0291] In various implementations, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 periodically, scheduledly, or at other times ping the implanted smart medical device 2802 to determine whether the implanted smart medical device 2802 is within 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 medical device 2802, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 determine that the implanted smart medical device 2802 is within communication range, and the implanted smart medical device 2802 may be requested, commanded, or otherwise instructed to transmit its connected data to one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807.

[0292] In some cases, each of one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 may be equipped with a corresponding optional user interface. The user interface may be configured as a multimedia interface that transmits one or more types of multimedia information (e.g., video, audio, haptic feedback, etc.) unidirectionally or bidirectionally. Through the corresponding user interface of one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807, the patient ( Figure 28 (not shown in the image) or the patient's partner ( Figure 28 (Not shown) Other data can be input to supplement the data collected by the implanted smart medical device 2802. For example, the user can input personal description information (e.g., changes in age, weight), changes in medical condition, comorbidities, pain levels, quality of life, instructions on how the implanted smart medical device 2802 "feels," or other subjective measurement data, personal information provided to a healthcare professional, etc. In these embodiments, the personal description information can be input using a keyboard, mouse, touchscreen, microphone, wired or wireless computing interface, or some other input method. When collecting personal description information, it may include or otherwise be associated with one or more identifiers that link the information to a unique identifier of the implanted smart medical device 2802, the patient, the associated healthcare professional, the relevant healthcare institution, etc.

[0293] In some of these cases, the corresponding optional user interface of each of one or more of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807 may also be arranged to deliver information associated with the implanted smart medical device 2802 to a user, for example, a medical professional. In these cases, the information may be delivered to the user via a video screen, an audio output device, a haptic transducer, a wired or wireless computing interface, or some other similar means.

[0294] In one or more embodiments where a user interface is arranged in the home base station 2804, the external smart device 2805, and the connected personal assistant 2807, the user interface may be configured for communication coupling to a patient portal device. The patented portal device may be a smartphone, tablet, wearable device, weight or other health measurement device (e.g., thermometer, bathroom scale, etc.), or some other computing device capable of wired or wireless communication. In these cases, the user can input personal descriptive information, and the user can also receive information related to the implanted smart medical device 2802.

[0295] Home base station 2804 utilizes the patient's home network 2806 to transmit collected data to cloud 2808. Home network 2806, which may be a local area network (LAN), provides access from the patient's home to a wide area network (WAN), such as the Internet. In some implementations, home base station 2804 may utilize a Wi-Fi connection to connect to home network 2806 and access the Internet. In other implementations, home base station 2804 may connect to the patient's home computer (…). Figure 28 (Not shown in the image), such as via a USB connection that connects to the home network 2806 itself.

[0296] External smart devices 2805 can be accessed via, for example, Blue... The compatible signal communicates directly with the implanted smart medical device 2802, and the collected data can be transmitted to the cloud 2808 via the patient's home network 2806, or, for example, via a cellular network, directly with the cloud. Optionally, the external smart device 2805 is configured to communicate via, for example, BlueNet. The compatible signal communicates directly with one or both of the home base station 2804 and the connected personal assistant 2807, and is not configured to communicate directly with the implanted smart medical device 2802.

[0297] Furthermore, the connected personal assistant 2807 can be accessed via, for example, Blue. The compatible signal communicates directly with the implanted smart medical device 2802 and can transmit the collected data to the cloud 2808 via the patient's home network 2806, or can communicate directly with the cloud, for example, via a modem / internet connection or cellular network. Optionally, the connected personal assistant 2807 is configured to communicate via, for example, Blue... The compatible signal communicates directly with one or both of the home base station 2804 and the external smart device 2805, and is not configured to communicate directly with the implanted smart medical device 2802.

[0298] In addition to transmitting the collected data to the cloud 2808, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can also 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 device 2805, and connected personal assistant 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, updated configuration information, diagnostic requests to determine whether the implanted smart medical device 2802 is functioning correctly, data collection requests, and other information.

[0299] Cloud 2808 may include one or more server computers or databases to aggregate data from implanted smart medical devices 2802 and, in some cases, from patients ( Figure 28 The data collected (not shown) includes personal description information collected from other components (not illustrated), and in some cases, from other patients. In this way, the Cloud 2808 can create various metrics about the data collected from each of the multiple components implanted in a single patient. This information may help determine whether a component is functioning correctly. The collected information may also be helpful for other purposes, such as determining which specific devices may not function correctly, determining whether procedures or conditions associated with the smart medical device are helping the patient (e.g., whether a knee replacement is functioning correctly and alleviating the patient's pain), and determining other medical information.

[0300] Still referencing Figure 28 Alternative implementation schemes are envisioned. For example, one or two of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can be omitted from the smart medical device environment 2800. Furthermore, each of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can be configured to communicate with one or two of the implanted smart medical device 2802 and cloud 2808 via another or two of the base station, smart device, and connected personal assistant. Additionally, the external smart device 2805 can be temporarily reduced to an interface with the implanted smart medical device 2802 and can be any suitable device other than a smartphone, such as a smartwatch, smart patch, and any IoT device, such as a coffee maker capable of acting as an interface with the implanted smart medical device 2802.

[0301] Additionally, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can act as a communication hub for implanting multiple prostheses in one or more patients. Furthermore, if medical professionals and insurance companies have pre-authorized such orders or reorders, 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 in response to patient input or implantable prosthesis input (e.g., pain level, instability level); optionally, one or more of the base station, smart device, and connected personal assistant can be configured to request authorization to place or reorder orders from medical professionals or insurance companies. Furthermore, one or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can be configured with a personal assistant, such as… or

[0302] Although the environment for intelligent medical devices has been referenced Figure 28 The description is based on a patient's home setting, but the same principles apply when the environment is an operating room or a healthcare professional's office. For example, in conjunction with a medical procedure, an implanted smart medical device 2802 can be implanted in a patient within an operating room environment. Simultaneously with the medical procedure, the implanted smart medical device 2802 communicates with a base station in the operating room (similar to a home base station). Subsequently, after full recovery from the medical procedure, the patient returns home, where the implanted smart medical device 2802 is positioned to communicate with a base station in the healthcare professional's office when the patient visits for follow-up appointments. In all cases, the implanted smart medical device 2802 communicates with each base station via short-range network protocols such as Medical Implant Communication Service (MICS), Medical Device Radio Communication Service (MedRadio), or some other wireless communication protocol suitable for the smart medical device 2802.

[0303] For example, the implantation of the smart medical device 2802 into a patient can occur in an operating room. As used herein, an operating room includes any office, room, building, or facility in which the smart medical device 2802 is implanted into the patient. For example, an operating room can be a typical operating room in a hospital, an operating room in a surgical clinic or a medical practitioner's office, or any other operating room in which the smart medical device 2802 is implanted into the patient.

[0304] Operating room base station (similar to) Figure 28 The home base station is used to configure and initialize the implantable smart medical device 2802 associated with the smart medical device 2802 implanted in the patient. For example, a communication relationship is established between the smart medical device 2802 and the operating room base station based on polling signals transmitted by the operating room base station and response signals transmitted by the smart medical device 2802.

[0305] When establishing a communication relationship, which typically occurs before the implantation of the smart medical device 2802, the operating room base station transmits initial configuration information to the smart medical device 2802. This initial configuration information may include, but is not limited to, timestamps, datestamps, the type and placement identifier of the smart medical device 2802, information about other implants associated with the smart medical device, surgeon information, patient identifier, operating room information, etc.

[0306] In some implementations, initial configuration information is transmitted unidirectionally; in others, it is transmitted bidirectionally. The initial configuration information may define at least one parameter associated with data collection by the smart medical device 2802. For example, the configuration information may identify settings for one or more sensors on the smart medical device 2802 for each of one or more operating modes. The configuration information may also include other control information such as the initial operating mode of the smart medical device 2802, specific events that trigger a change in operating mode, wireless settings, data collection information (e.g., the frequency at which the smart medical device 2802 wakes up to collect data, the time it collects data, and the amount of data collected), identification information for the home base station 2804, the smart device 2805, and the connected personal assistant 2807, as well as other control information related to implantation or operation of the smart medical device 2802. Examples of a connected personal assistant 2807, also referred to as a smart speaker, include Amazon. Amazon Google Patient monitors, Comcast health tracking speakers, and Apple

[0307] In some embodiments, configuration information may be pre-stored on the operating room base station or an associated computing device. In other embodiments, surgeons, surgical technicians, or other medical practitioners may input control information and other parameters into 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 enables medical practitioners 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 predefined configuration information, which medical practitioners may or may not adjust.

[0308] The operating room configuration computing device communicates configuration information to the operating room base station via a wired or wireless network connection (e.g., via USB connection, Bluetooth connection, Bluetooth Low Energy (BTLE) connection, or Wi-Fi connection), which in turn communicates it to the smart medical device 2802.

[0309] The operating room configuration computing device can also display information about the smart medical device 2802 or the operating room base station to surgeons, surgical technicians, or other medical professionals. For example, if the smart medical device 2802 cannot store or access configuration information, if the smart medical device 2802 does not respond, if the smart medical device 2802 identifies a problem related to one of the sensors or radios during initial self-test, if the operating room base station is unresponsive or malfunctions, or for other reasons, the operating room configuration computing device can display error messages.

[0310] Although the operating room base station and the operating room configuration computing device are described as separate devices, the implementation is not limited to this; rather, the functionality of the operating room configuration computing device and the operating room base station may be included in a single computing device or a separate device as shown in the figure. In this way, in one implementation, medical practitioners can be enabled to directly input configuration information into the operating room base station.

[0311] After a smart medical device is implanted in a patient, the patient can periodically visit the doctor's office for follow-up evaluations. This disclosure provides, for one hand, a doctor's office environment (similar to the home environment described herein), in which the implanted smart medical device communicates with the office environment. During these visits, data already stored in memory can be accessed, and / or specific data can be requested and retrieved as part of the monitoring process.

[0312] For example, at different times throughout the monitoring process, the patient may be asked to visit a healthcare professional for a follow-up appointment. This healthcare professional could be the surgeon who implants the smart medical device 2802 in the patient, or a different healthcare professional supervising the patient's monitoring process, physical therapy, and recovery. For various reasons, the healthcare professional may want to collect real-time data from the smart medical device 2802 in a controlled environment. In some cases, the request to access the healthcare professional can be delivered via a corresponding optional two-way user interface of one or more of the following: a home base station 2804, an external smart device 2805, and a connected personal assistant 2807.

[0313] Healthcare professionals use a doctor's office base station (similar to) that communicates with the smart medical device 2802. Figure 28 The home base station shown in the diagram) transmits additional data between the doctor's office base station and the smart medical device 2802. Optionally or additionally, medical practitioners utilize the doctor's office base station ( Figure 28(Not shown in the image) The command is transmitted to the smart medical device 2802. In some embodiments, the doctor's office base station instructs the smart medical device 2802 to enter a high-resolution mode to temporarily increase the rate or type of data collected over a short period of time. The high-resolution mode instructs the smart medical device 2802 to collect different (e.g., large amounts) amounts of data while the medical practitioner is also monitoring the patient's activities.

[0314] In some implementations, the doctor's office base station enables healthcare practitioners to input events or pain markers, which can be synchronized with high-resolution data collected via the smart medical device 2802. For example, when the smart medical device 2802 is in high-resolution mode, the healthcare practitioner can have a patient walk on a treadmill. While walking, the patient may complain of pain. The healthcare practitioner can tap a pain marker button on the doctor's office base station to indicate the patient's discomfort. The doctor's office base station records the marker and the time of its input. When the time of this marker is synchronized with the time of the collected high-resolution data, the healthcare practitioner can analyze the data to try and determine the cause of the pain.

[0315] In other implementations, the physician's office base station can provide updated configuration information to the smart medical device 2802. The smart medical device 2802 can store this updated configuration information, which can be used to adjust parameters related to the collected data. For example, if the patient is in good condition, the healthcare professional can instruct the smart medical device 2802 to reduce the frequency of data collection. Conversely, if the patient is experiencing an unexpected amount of pain, the healthcare professional can instruct the smart medical device 2802 to collect additional data over a defined period of time (e.g., several days). The healthcare professional can use this additional data to diagnose and treat specific problems. In some cases, the additional data may include personal descriptive information provided by the patient after the patient leaves the healthcare professional's presence and is no longer within range of the physician's office base station. In these cases, personal descriptive information can be collected and transmitted via one or more of the home base station 2804, the external smart device 2805, and the connected personal assistant 2807. Firmware within the smart medical device and / or base station will provide safeguards to limit the duration of this enhanced monitoring, ensuring that the smart medical device 2802 retains sufficient power for continued use throughout the implant's lifespan.

[0316] In various implementations, the physician office base station can communicate with a physician office configuration computing device (similar to an operating room computing device). The physician office configuration computing device includes an application with a graphical user interface (GUI) that enables medical practitioners to input commands and data. Some or all of the commands, data, and other information can later be transmitted to the smart medical device 2802 via the physician office base station. For example, in some implementations, the medical practitioner can use the GUI to instruct the smart medical device 2802 to enter its high-resolution mode. In other implementations, the medical practitioner can use the GUI to input or modify configuration information for the smart medical device 2802. The physician office configuration computing device transmits information (e.g., commands, data, or other information) to the physician office base station via a wired or wireless network connection (e.g., via USB, Bluetooth, or Wi-Fi), which in turn transmits some or all of the information to the smart medical device 2802.

[0317] The physician office configuration computing device can also display other information to healthcare professionals regarding the smart medical device 2802, the patient (e.g., personal description information), or the physician office base station. For example, the physician office configuration computing device can display high-resolution data collected by the smart medical device 2802 and transmitted to the physician office base station. The physician office configuration computing device can also display error messages if the smart medical device 2802 cannot store or access configuration information, if the smart medical device 2802 is unresponsive, if the smart medical device 2802 identifies a problem with one of the sensors or radios, if the physician office base station is unresponsive or malfunctioning, or for other reasons.

[0318] In some implementations, the physician office-configured computing device can access cloud 2808. In at least one implementation, a healthcare practitioner can utilize the physician office-configured computing device to access data stored in cloud 2808, which was previously collected by smart medical device 2802 and transmitted to cloud 2808 via one or both of home base station 2804 and external smart device 2805. Similarly, the physician office-configured computing device can transmit high-resolution data obtained from smart medical device 2802 to cloud 2808 via physician office base station. In some implementations, the physician office base station may have internet access and may enable the direct transmission of high-resolution data to cloud 2808 without using the physician office-configured computing device.

[0319] In various implementations, when the patient is not in the healthcare professional's office, the healthcare professional can update the configuration information of the smart medical device 2802. In these cases, the healthcare professional can utilize the doctor's office to configure the computing device ( Figure 28(Not shown in the image), the updated configuration information is transmitted to the smart medical device 2802 via the cloud 2808. One or more of the home base station 2804, external smart device 2805, and connected personal assistant 2807 can obtain the updated configuration information from the cloud 2808 and transmit it to the cloud. This allows healthcare professionals to remotely adjust the operation of the smart medical device 2802 without the patient needing to come to the healthcare professional's office. It also allows healthcare professionals to send messages to patients in response to, for example, messages provided by the patient and transmitted via the home base station 2804, external smart device 2805, and connected personal assistant 2807 to the doctor's office base station (…). Figure 28 (Not shown in the image) Personal description information. For example, if a patient tells the connected personal assistant 2807, "I feel pain," then the healthcare professional can prescribe pain medication, causing the connected personal assistant to request medication from your preferred pharmacy by saying, "The doctor requests..." The prescription will be ready for pickup at 4 p.m., and the patient will be notified.

[0320] Despite the doctor's office base station ( Figure 28 (not shown in the image) and the doctor's office is equipped with a computing device ( Figure 28 (Not shown) is described as a separate device, but the implementation is not limited to this; instead, the functionality of the physician office configuration computing device and the physician office base station can be included in a single computing device or a separate device (as shown). In this way, in one implementation, healthcare practitioners can be enabled to directly input configuration information or tags into the physician office base station and view high-resolution data (and synchronized tag information) on a display on the physician office base station.

[0321] For ease of reference, certain exemplary embodiments of this disclosure, numbered as such, include the following:

[0322] 1. A medical device, comprising:

[0323] A structure having at least a lumen extending from it, and configured to be at least partially implanted in the body; and

[0324] An electronic box, which includes electronic components and is configured to be inserted into a lumen behind an implant structure.

[0325] 2. The medical device according to embodiment 1 further includes a sensor for measuring the electrical properties of tissue, said sensor comprising:

[0326] Multiple electrodes; and

[0327] The sensing module of the electronic box is coupled to multiple electrodes.

[0328] 3. The medical device as described in embodiment 2, wherein:

[0329] Multiple electrodes include a first electrode and a second electrode; and

[0330] The sensing module is configured to enable the first and second electrodes to function in either an application mode or a sensing mode, applying a signal through the electrodes during the application mode and sensing the impedance between the electrodes during the sensing mode.

[0331] 4. The medical device of embodiment 3, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0332] 5. The medical device as described in embodiment 2, wherein:

[0333] The sensor also includes electrode switches;

[0334] Multiple electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode that can be switched and coupled via an electrode switch and a sensing module; and

[0335] The sensing module is configured to implement an application mode and a sensing mode. In the application mode, signals are applied through the first electrode and the second electrode, and in the sensing mode, the impedance between the third electrode and the fourth electrode is sensed.

[0336] 6. The medical device of embodiment 5, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0337] 7. The medical device of embodiment 2, wherein the electrical properties of the tissue include impedance measurement, and further includes a controller configured to process the impedance measurement over time to determine fracture characterization corresponding to the healing state of the fracture.

[0338] 8. The medical device as described in embodiment 7, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0339] 9. The medical device as described in embodiment 2, wherein:

[0340] Multiple electrodes are associated with and spaced apart from the structure to allow for the placement of the first and second electrodes on opposite sides of the fracture; and

[0341] The electronic box includes multiple electrical contacts that are electrically coupled to multiple electrodes when positioned within the cavity of the electronic box insertion structure.

[0342] 10. The medical device as described in embodiment 2, wherein:

[0343] Multiple electrodes are coupled to and spaced apart from an electronic box to allow the placement of the first and second electrodes on opposite sides of the fracture.

[0344] 11. The medical device as described in embodiment 10, wherein:

[0345] The structure includes at least one hole through the sidewall; and

[0346] Multiple electrodes are positioned on the electronic box to align with at least one hole when the electronic box is inserted into the cavity of the structure.

[0347] 12. The medical device as described in embodiment 10, wherein:

[0348] The structure includes a distal opening and a proximal opening; and

[0349] Multiple electrodes include a first electrode positioned on the electronic box near the distal opening when the electronic box is inserted into the lumen of the electronic box insertion structure, and a second electrode positioned on the electronic box near the proximal opening.

[0350] 13. The medical device as described in embodiment 10, wherein:

[0351] The structure includes a distal opening; and

[0352] The plurality of electrodes includes a first electrode and a second electrode, each of which is positioned on the electronic box to be positioned at the distal end of the distal opening of the structure when the electronic box is inserted into the lumen of the structure.

[0353] 14. The medical device according to any one of embodiments 1-13, wherein the lumen is configured to receive an implantation tool during implantation.

[0354] 15. The medical device of embodiment 14, wherein the structure includes a head of a recessed pocket having a defined lumen head portion, the lumen being configured to receive part of an implantation tool to enable the transmission of torque applied to the implantation tool to the structure.

[0355] 16. The medical device according to any one of embodiments 1-15, wherein the structure is configured to be implanted in bone.

[0356] 17. The medical device as described in embodiment 16, wherein the structure is configured for implantation to bridge fractures.

[0357] 18. The medical device as described in embodiment 16, wherein the structure is configured for implantation through a hole in a plate bridging a fracture.

[0358] 19. The medical device according to any one of embodiments 1-18, wherein the structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device or other orthopedic device.

[0359] 20. The medical device according to any one of embodiments 1-19, wherein the structure includes a shaft having an outer diameter of 4 mm or greater.

[0360] 21. The medical device according to any one of embodiments 1-20, wherein the lumen includes a shaft portion having a diameter sized to be at least a portion of the receiving electronic box.

[0361] 22. The medical device according to any one of embodiments 1-21, wherein each of the electronic box and the lumen has substantially the same shape factor.

[0362] 23. The medical device of embodiment 22, wherein the shape factors of the electronic box and the lumen respectively include a head portion and an axle portion, wherein the head portion has a diameter greater than that of the axle portion.

[0363] 24. The medical device according to any one of embodiments 1-23, wherein the structure and the electronic box include mechanical features that enable the electronic box to be securely fastened within the lumen.

[0364] 25. The medical device of embodiment 24, wherein the mechanical features include one of the following: a difference in shape factor between the head of the electronic box and the head portion of the lumen of the structure; a protrusion associated with the electronic box and a recess associated with the lumen of the structure; and an interlocking feature associated with the axis of the electronic box for receiving a crosslinking agent and an inner wall of the structure for engaging the crosslinking agent.

[0365] 26. The medical device according to any one of embodiments 1-25, wherein the structure and the electronic box include mechanical features that enable the removal of the electronic box from the lumen without compromising the structural integrity of the electronic box or the structure.

[0366] 27. The medical device as described in embodiment 26, wherein the mechanical features include complementary threads.

[0367] 28. The medical device according to any one of embodiments 1-27, wherein the electronic box includes a head and a shaft, and at least a portion of the electronic components are included in an electronic assembly located in the head.

[0368] 29. The medical device according to any one of embodiments 1-28, wherein the electronic box includes a head and a shaft, and at least a portion of the electronic components are included in an electronic assembly located in the shaft.

[0369] 30. The medical device according to any one of embodiments 1-29, wherein:

[0370] The structure includes an outer surface, and one or more electrodes are located on the outer surface; and

[0371] The electronic box includes an outer surface and one or more electrical contacts at the outer surface configured to be electrically coupled to one or more electrodes when the electronic box is inserted into a lumen.

[0372] 31. The medical device of embodiment 30, wherein the structure includes a conductive substrate, and one or more electrodes correspond to a conductive material associated with a sidewall of the conductive substrate and electrically isolated from the conductive substrate by an electrically insulating material.

[0373] 32. The medical device of embodiment 31 further includes a feedthrough for each of one or more electrodes, the feedthrough extending through a sidewall of a conductive substrate and providing electrical coupling between each of the one or more electrodes and the interior of the structure.

[0374] 33. The medical device of embodiment 30, wherein the structure includes a conductive substrate at least partially coated with an electrically insulating material, and one or more electrodes correspond to one or more of the following:

[0375] Conductive substrate areas not coated with electrical insulating material; and

[0376] Conductive substances on electrically insulating materials.

[0377] 34. The medical device of embodiment 30, wherein the structure includes a substrate and one or more electrodes correspond to a conductive material on the substrate.

[0378] 35. The medical device as described in embodiment 34, wherein the substrate has a non-conductive material.

[0379] 36. The medical device as described in embodiment 34, wherein:

[0380] The substrate has a conductive material; and

[0381] One or more electrodes correspond to conductive material on an electrically insulating material.

[0382] 37. The medical device of embodiment 30, wherein the structure includes a proximal end and a distal end, and one or more electrodes include one or more of the following: a distal electrode near the distal end, a proximal electrode near the proximal end, a plurality of distal electrodes near the distal end, a plurality of proximal electrodes near the proximal end, and a plurality of electrodes between the proximal end and the distal end.

[0383] 38. The medical device of embodiment 30, wherein one or more electrodes are electrically isolated from each other and from the structure.

[0384] 39. The medical device according to any one of embodiments 1-38, wherein:

[0385] The structure includes one or more holes through the sidewalls; and

[0386] The electronic box includes one or more electrodes that are aligned with one or more holes when positioned in the lumen of the electronic box insertion structure.

[0387] 40. The medical device of embodiment 39, wherein each of the structure and the electronic cartridge is configured to align each of one or more electrodes with a corresponding one of one or more holes when the electronic cartridge is inserted into the lumen.

[0388] 41. The medical device of embodiment 39, wherein the electronic box includes a proximal end and a distal end, and one or more electrodes include one or more of the following: a distal electrode near the distal end, a proximal electrode near the proximal end, a plurality of distal electrodes near the distal end, a plurality of proximal electrodes near the proximal end, and a plurality of electrodes between the proximal end and the distal end.

[0389] 42. The medical device as described in embodiment 39, wherein one or more electrodes are electrically isolated from each other.

[0390] 43. The medical device as described in embodiment 39, wherein:

[0391] One or more holes correspond to slots; and

[0392] The electronic box includes an electrode assembly extending outward from the surface of the electronic box, having shape factors suitable for passing through a slot, and including one or more electrodes.

[0393] 44. The medical device of embodiment 43, wherein the electrode assembly is biased relative to the surface of the electronic box such that the electronic box can transition between a compressed state and an expanded state, wherein the outer surface of the electrode assembly is substantially flush with the surface of the electronic box during the compressed state, and the outer surface of the electrode assembly is raised relative to the surface of the electronic box during the expanded state to extend through the slot.

[0394] 45. The medical device of embodiment 39, wherein the electrode is axially associated with the electronic box and includes an electrode surface recessed relative to the surface of the axis, such that when inserted into the lumen of the structure, an empty space communicating with the hole is formed between the electrode surface and the inner wall of the structure.

[0395] 46. ​​The medical device according to any one of embodiments 1-45, wherein:

[0396] The structure includes a distal opening and a proximal opening; and

[0397] The electronic box includes a first electrode positioned near the distal opening and a second electrode positioned near the proximal opening when the electronic box is inserted into the lumen of the structure.

[0398] 47. The medical device according to any one of embodiments 1-46, wherein:

[0399] The structure includes a distal opening; and

[0400] The electronic box includes multiple electrodes positioned on the electronic box to be positioned at the distal end of the distal opening of the structure when the electronic box is inserted into the lumen of the structure.

[0401] 48. The medical device according to any one of embodiments 1-47, wherein the electronic components include an antenna.

[0402] 49. The medical device as described in embodiment 48, wherein:

[0403] The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and

[0404] The antenna is associated with the axis.

[0405] 50. The medical device of embodiment 49, wherein the antenna comprises a conductive line or a trace extending along the length of an axis.

[0406] 51. The medical device as described in embodiment 50, wherein the antenna extends about an axis in a helical pattern.

[0407] 52. The medical device of embodiment 51, wherein the antenna is electrically insulated from the outer surface of the shaft to avoid contact with the structure when the electronic box is inserted into the lumen of the structure.

[0408] 53. The medical device as described in embodiment 48, wherein:

[0409] The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and

[0410] The antenna is associated with the head.

[0411] 54. The medical device of embodiment 53, wherein the antenna includes a conductive line or trace extending along a plane parallel to the bottom of the head.

[0412] 55. The medical device according to any one of embodiments 1-55, wherein the electronic components include one or more power sources.

[0413] 56. The medical device as described in embodiment 55, wherein:

[0414] The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and

[0415] One or more energy sources are associated with the axis.

[0416] 57. The medical device as described in embodiment 55, wherein:

[0417] The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and

[0418] One or more energy sources are associated with the head.

[0419] 58. The medical device of embodiment 55, wherein one or more power sources include one or more of batteries and capacitors.

[0420] 59. The medical device of embodiment 55, wherein one or more energy sources include an energy harvesting device configured to harvest energy via electrostatic energy, wireless power transfer, electromechanical conversion, electromagnetic conversion, and IR radiation.

[0421] 60. The medical device according to any one of embodiments 1-59, wherein the electronic components include one or more communication components capable of communicating between the medical device and another device implanted in or outside the body.

[0422] 61. The medical device of embodiment 60, wherein one or more communication components include:

[0423] Antenna; and

[0424] A radio frequency (RF) transceiver coupled to an antenna and configured to receive and transmit RF signals.

[0425] 62. The medical device of embodiment 60, wherein one or more communication components include:

[0426] Transmitter, coupled to electrodes associated with a medical device and configured and positioned for contact with tissue; and

[0427] A receiver, which is coupled to an electrode associated with a medical device and configured and positioned to contact tissue.

[0428] 63. The medical device of embodiment 60, wherein one or more communication components are configured to achieve at least one of the following:

[0429] To achieve capacitive coupling between a medical device and another device; or

[0430] To achieve current coupling between a medical device and another device.

[0431] 64. The medical device according to any one of embodiments 1-63, wherein the electronic components include one or more sensors.

[0432] 65. The medical device of embodiment 64, wherein one or more sensors include an accelerometer configured to output a signal corresponding to structural motion.

[0433] 66. The medical device of embodiment 65, wherein the accelerometer includes one of a one-dimensional accelerometer and a three-dimensional accelerometer.

[0434] 67. The medical device of embodiment 65, wherein the electronics further includes a processor coupled to an accelerometer to receive signals and configured to process the signals to provide indications of one or more of patient activity, structural integrity, and structural movement relative to the implantation site.

[0435] 68. The medical device of 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 implantation site.

[0436] 69. The medical device of embodiment 64, wherein one or more sensors include stress sensors configured to output signals corresponding to motion, force, tension, velocity or other mechanical forces associated with a structure.

[0437] 70. The medical device of embodiment 69, wherein the electronics further includes a processor coupled to the stress sensor to receive signals from the stress sensor over time, and configured to process the signals to provide a characterization of the fracture, characterizing the healing state corresponding to the fracture.

[0438] 71. The medical device of embodiment 64, wherein one or more sensors include an ultrasonic transducer configured to output an ultrasonic energy signal corresponding to a region of the structure.

[0439] 72. The medical device of embodiment 71, wherein the electronic device further includes a processor coupled to an ultrasound transducer to receive signals from the ultrasound transducer and configured to process the signals to provide one or more of the following: characterization of a fracture, characterization of tissue in a region of structure, and glucose in a healing region.

[0440] 73. The medical device of embodiment 64, wherein one or more sensors include one or more of a glucose detector and an oxygen sensor configured to output signals corresponding to one of a glucose level and an oxygen level, respectively.

[0441] 74. The medical device of embodiment 73, wherein the electronics further includes a processor coupled to one or more of a glucose detector and an oxygen sensor to receive signals and configured to process the signals to provide an indication of inflammatory fluid in a region of the medical device.

[0442] 75. The medical device according to any one of embodiments 1-74, wherein the electronic box further includes a mechanism configured to deliver a catalytic substance that generates gaseous oxygen at the implantation site through a chemical reaction.

[0443] 76. The medical device as described in embodiment 75, wherein the mechanism comprises one or more of the following:

[0444] A reservoir that, under the control of a time-release controller, releases the catalyst once or multiple times after implantation; and

[0445] Catalytic coating on the electronic box.

[0446] 77. A medical device comprising:

[0447] An insertion cannula having a lumen extending therefrom and a plurality of electrodes on its outer surface, the insertion cannula being configured to be at least partially implanted in the body; and

[0448] An electronic box, including electronic components, is configured to be inserted into a lumen and, upon such insertion, establish one or more electrical couplings between the electronic components and multiple electrodes.

[0449] 78. The medical device of embodiment 77, wherein the cannulation structure includes an axis, and the plurality of electrodes include single sets of electrodes spaced apart along the length of the axis.

[0450] 79. The medical device of embodiment 77, wherein the cannulation structure includes a shaft, and the plurality of electrodes include a first set of electrodes spaced apart along a first side of the shaft and a second set of electrodes spaced apart along a second side spaced apart from the first side.

[0451] 80. The medical device of embodiment 77, wherein the cannulation structure includes a shaft, and the plurality of electrodes include a first linear electrode on a first side of the shaft and a second linear electrode on a second side spaced apart from the first side.

[0452] 81. The medical device as described in embodiment 77, wherein the cannulation structure includes:

[0453] A conductive body having an outer surface at least partially coated with an electrically insulating material.

[0454] The first electrode of the plurality of electrodes corresponds to the exposed portion of the conductive body, and

[0455] A second electrode of multiple electrodes is coated on a portion of an electrically insulating material.

[0456] 82. The medical device as described in embodiment 81, wherein the electronic box comprises:

[0457] The first electrical contact is positioned to contact the inner surface of the conductive body, thereby establishing electrical coupling between the electronic device and the first electrode; and

[0458] The second electrical contact is positioned to contact a portion of the second electrode, thereby establishing electrical coupling between the electronic device and the second electrode.

[0459] 83. The medical device of embodiment 82, wherein the electronic box further includes an insulating seal between the first electrical contact and the second electrical contact.

[0460] 84. The medical device of embodiment 82, wherein the second electrode is partially coated with an electrically insulating material, and the portion of the second electrode that contacts the second electrical contact corresponds to the uncoated portion of the second electrode.

[0461] 85. The medical device of embodiment 84, wherein the uncoated portion of the second electrode is positioned in the head portion of the lumen at the proximal end of the cannulation structure.

[0462] 86. The medical device as described in embodiment 77, wherein the cannulation structure includes:

[0463] A body having a head and an outer surface at least partially coated with an electrically insulating material;

[0464] A first portion of conductive material on an electrically insulating material forming a first electrode with multiple electrodes, a first electrical contact near the head, and a first conductive path between the first electrode and the first electrical contact; and

[0465] The second part of the conductive material on the electrically insulating material forming the second electrode with multiple electrodes, the second electrical contact near the head, and the second conductive path between the second electrode and the second electrical contact.

[0466] 87. The medical device as described in embodiment 86, wherein the electronic box comprises:

[0467] The first electrical contact, positioned as the first electrical contact of the contact cannula structure, thereby establishing electrical coupling between the electronic device and the first electrode; and

[0468] The second electrical contact is positioned as the second electrical contact of the contact tube structure, thereby establishing electrical coupling between the electronic device and the second electrode.

[0469] 88. The medical device as described in embodiment 77, wherein the cannulation structure includes:

[0470] The distal component of a first electrode comprising multiple electrodes; and

[0471] The proximal component of a second electrode comprising multiple electrodes.

[0472] 89. The medical device of embodiment 88, wherein each of the distal and proximal components includes a conductive substrate having an outer surface coated at least partially with an electrically insulating coating.

[0473] 90. The medical device of embodiment 88, wherein each of the distal and proximal components includes a mechanical feature capable of enabling mechanical coupling between the distal and proximal components.

[0474] 91. The medical device of embodiment 77, wherein the cannulation structure and the electronic box include mechanical features that enable the electronic box to be securely fastened in the lumen.

[0475] 92. The medical device of embodiment 91, wherein the mechanical features include one of the following: a difference in shape factor between the head of the electronic box and the head portion of the lumen of the cannula structure; a protrusion associated with the electronic box and a recess associated with the lumen of the cannula structure; and an interlocking feature associated with the axis of the electronic box for receiving a crosslinking agent and with the inner wall of the cannula structure for engaging the crosslinking agent.

[0476] 93. The medical device of embodiment 77, wherein the cannulation structure and the electronic box include mechanical features that enable the removal of the electronic box from the lumen without compromising the structural integrity of the electronic box or the cannulation structure.

[0477] 94. The medical device as described in embodiment 93, wherein the mechanical features include complementary threads.

[0478] 95. A medical device comprising:

[0479] An insertion cannula having a lumen extending therefrom and at least one orifice through a sidewall of the insertion cannula, the insertion cannula being configured to be at least partially implanted in the body; and

[0480] An electronic box comprising multiple electrodes and electronic devices electrically coupled to the electrodes, the electronic box being configured to be inserted into a lumen and, upon such insertion, to provide alignment between the multiple electrodes and at least one aperture.

[0481] 96. The medical device as described in embodiment 95, wherein:

[0482] At least one hole corresponds to a slot; and

[0483] The electronic box includes an electrode assembly that extends outward from the surface of the electronic box, has shape factors suitable for passing through a slot, and includes multiple electrodes.

[0484] 97. The medical device of embodiment 96, wherein the electrode assembly is biased relative to the surface of the electronic box to enable the electronic box to be switched between a compressed state and an expanded state, wherein during the compressed state the outer surface of the electrode assembly is substantially flush with the surface of the electronic box, and during the expanded state the outer surface of the electrode assembly is raised relative to the surface of the electronic box to extend through the slot.

[0485] 98. The medical device as described in embodiment 95, wherein:

[0486] At least one hole corresponds to multiple holes; and

[0487] The electronic box includes multiple corresponding electrodes.

[0488] 99. The medical device of embodiment 98, wherein a plurality of electrodes are annular electrodes recessed relative to the surface of the electronic box, such that when inserted into the lumen of the cannula structure, an annular space communicating with the hole is formed between the electrode surface and the inner wall of the cannula structure.

[0489] 100. The medical device of embodiment 98, wherein the plurality of electrodes includes a distal electrode and a proximal electrode.

[0490] 101. The medical device of embodiment 98, wherein the plurality of electrodes comprise more than two electrode arrangements in an array between the distal and proximal electrodes.

[0491] 102. A medical device comprising:

[0492] A cannulation structure having a lumen extending therefrom, a distal opening, and a proximal opening, the cannulation structure being configured to be at least partially implanted in the body; and

[0493] An electronic box comprising a plurality of electrodes and electronic devices electrically coupled to the electrodes, the electronic box being configured to be inserted into a lumen, and upon such insertion positioning a first electrode of the plurality of electrodes at a distal opening and a second electrode of the plurality of electrodes at a proximal opening.

[0494] 103. The medical device of embodiment 102, wherein the first electrode is an annular electrode recessed relative to the surface of the electronic box, such that when inserted into the lumen, an annular space communicating with the distal opening is formed between the surface of the first electrode and the inner wall of the cannulation structure.

[0495] 104. The medical device of embodiment 102, wherein the cannulation structure includes a head having a periphery, and a second electrode extends outward from the electronic box and beyond the periphery.

[0496] 105. A medical device comprising:

[0497] A cannulation structure having a lumen extending therefrom, and a distal opening and a proximal opening, the cannulation structure being configured to be at least partially implanted in the body; and

[0498] An electronic box comprising multiple electrodes and electronic devices electrically coupled to the electrodes, the electronic box being configured to be inserted into a lumen and, upon such insertion, to position the multiple electrodes at the distal end of a distal opening.

[0499] 106. The medical device of embodiment 105, wherein the electronic box includes a shaft having a length and at least two portions along the length with different stiffnesses.

[0500] 107. The medical device of embodiment 106, wherein a plurality of electrodes are associated with the lower stiffness portions of at least two parts.

[0501] 108. The medical device as described in embodiment 106, wherein the electronic components are associated with the higher stiffness portions of at least two parts.

[0502] 109. A medical device configured for at least partial implantation within the body, the medical device comprising:

[0503] The structure has a head and a shaft, each of which defines a head cavity and a shaft cavity, respectively.

[0504] Electronic devices positioned in one or more head cavities and shaft cavities; and

[0505] At least one electrode associated with the shaft and electrically coupled to electronic devices.

[0506] 110. The medical device of embodiment 109, wherein the structure includes a shaft, and at least one electrode includes a single set of electrodes spaced apart along the length of the shaft.

[0507] 111. The medical device of embodiment 109, wherein the structure includes a shaft, and at least one electrode includes a first set of electrodes spaced apart along a length of a first side of the shaft, and a second set of electrodes spaced apart along a length of a second side spaced apart from the first side.

[0508] 112. The medical device of embodiment 109, wherein the structure includes a shaft, and at least one electrode includes a first linear electrode on a first side of the shaft and a second linear electrode on a second side spaced apart from the first side.

[0509] 113. The medical device of embodiment 109 further includes a sensor for measuring the electrical properties of tissue, the sensor comprising:

[0510] Multiple electrodes; and

[0511] A sensing module coupled with multiple electrodes.

[0512] 114. The medical device as described in embodiment 113, wherein:

[0513] Multiple electrodes include a first electrode and a second electrode; and

[0514] The sensing module is configured to enable the first and second electrodes to function in either an application mode or a sensing mode, applying a signal through the electrodes during the application mode and sensing the impedance between the electrodes during the sensing mode.

[0515] 115. The medical device of embodiment 114, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0516] 116. The medical device as described in embodiment 113, wherein:

[0517] The sensor also includes electrode switches;

[0518] Multiple electrodes include a first electrode, a second electrode, a third electrode, and a fourth electrode that can be switched and coupled via an electrode switch and a sensing module; and

[0519] The sensing module is configured to implement an application mode and a sensing mode. In the application mode, signals are applied through the first and second electrodes, and in the sensing mode, impedance is sensed between the third and fourth electrodes.

[0520] 117. The medical device of embodiment 116, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0521] 118. The medical device of embodiment 113, wherein the electrical properties of the tissue include impedance measurement, and further includes a controller configured to process the impedance measurement over time to determine the characterization of the fracture, characterizing the healing state corresponding to the fracture.

[0522] 119. The medical device as described in embodiment 118, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0523] 120. The medical device as described in embodiment 109, wherein the structure is configured to be implanted in bone.

[0524] 121. The medical device as described in embodiment 120, wherein the structure is configured to be implanted to bridge fractures.

[0525] 122. The medical device as described in embodiment 120, wherein the structure is configured for implantation through a hole in a plate bridging a fracture.

[0526] 123. The medical device as described in embodiment 109, wherein the structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device, or other orthopedic device.

[0527] 124. The medical device as described in embodiment 109, wherein the structure includes a shaft having an outer diameter in the range of 4 mm or greater.

[0528] 125. The medical device as described in embodiment 109, wherein:

[0529] The structure includes an outer surface and one or more electrodes at the outer surface that are electrically coupled to electronic devices.

[0530] 126. The medical device of embodiment 125, wherein the structure includes a substrate, and one or more electrodes correspond to a conductive structure extending from the outer surface along the sidewall of the substrate toward the electronic device.

[0531] 127. The medical device of embodiment 125, wherein the structure includes a substrate, and one or more electrodes correspond to a conductive structure extending through a hole through a sidewall of the substrate.

[0532] 128. The medical device of embodiment 127, wherein the conductive structure includes a layer of conductive material extending from the outer surface of the structure along the sidewall of the hole toward the inner surface of the structure.

[0533] 129. The medical device of embodiment 127, wherein the conductive structure includes a conductive pin extending through a hole.

[0534] 130. The medical device as described in embodiment 129, wherein the conductive pin is a pogo-type pin normally biased outward from the hole.

[0535] 131. The medical device of embodiment 129, wherein the conductive structure includes a conductive material filling the pores.

[0536] 132. The medical device of embodiment 129, wherein the substrate has a conductive material coated at least partially with an electrically insulating material.

[0537] 133. The medical device of embodiment 132, wherein the orifice has sidewalls coated with an electrically insulating material.

[0538] 134. The medical device of embodiment 129, wherein the substrate has a non-conductive material.

[0539] 135. The medical device of embodiment 125, wherein the structure includes a proximal end and a distal end, and one or more electrodes include one or more of the following: a distal electrode near the distal end, a proximal electrode near the proximal end, a plurality of distal electrodes near the distal end, a plurality of proximal electrodes near the proximal end, and a plurality of electrodes between the proximal end and the distal end.

[0540] 136. The medical device of embodiment 135, wherein one or more electrodes are electrically isolated from each other.

[0541] 137. The medical device as described in embodiment 109, wherein the electronic components include an antenna.

[0542] 138. The medical device as described in embodiment 137, wherein the antenna is associated with the axis of the structure.

[0543] 139. The medical device of embodiment 138, wherein the antenna includes a conductive line or trace extending along the length of an axis.

[0544] 140. The medical device of embodiment 139, wherein the antenna extends about an axis in a helical pattern.

[0545] 141. The medical device as described in embodiment 138, wherein the antenna is associated with the head of the structure.

[0546] 142. The medical device of embodiment 141, wherein the antenna includes a conductive line or trace extending along a plane parallel to the bottom of the head.

[0547] 143. The medical device as described in embodiment 109, wherein the electronic components include one or more power sources.

[0548] 144. The medical device as described in embodiment 143, wherein one or more energy sources are associated with the axis of the structure.

[0549] 145. The medical device as described in embodiment 143, wherein one or more power sources are associated with the head of the structure.

[0550] 146. The medical device of embodiment 143, wherein one or more power sources include one or more of batteries and capacitors.

[0551] 147. The medical device of embodiment 143, wherein one or more energy sources include an energy harvesting device configured to harvest energy via electrostatic energy, wireless power transfer, electromechanical conversion, electromagnetic conversion, and IR radiation.

[0552] 148. The medical device of embodiment 109, wherein the electronics include one or more communication components capable of communicating between the medical device and another device implanted in or outside the body.

[0553] 149. The medical device of embodiment 148, wherein one or more communication components include:

[0554] Antenna; and

[0555] A radio frequency (RF) transceiver coupled to an antenna and configured to receive and transmit RF signals.

[0556] 150. The medical device of embodiment 148, wherein one or more communication components include:

[0557] Transmitter, coupled to electrodes associated with a medical device and configured and positioned for contact with tissue; and

[0558] A receiver, which is coupled to an electrode associated with a medical device and configured and positioned to contact tissue.

[0559] 151. The medical device of embodiment 150, wherein one or more communication components are configured to be at least one of the following:

[0560] To achieve capacitive coupling between a medical device and another device; or

[0561] Achieve current coupling between a medical device and another device.

[0562] 152. The medical device as described in embodiment 109, wherein the electronic components include one or more sensors.

[0563] 153. The medical device of embodiment 152, wherein one or more sensors include an accelerometer configured to output a signal corresponding to structural motion.

[0564] 154. The medical device as described in embodiment 153, wherein the accelerometer includes one of a one-dimensional accelerometer and a three-dimensional accelerometer.

[0565] 155. The medical device of embodiment 153, wherein the electronics further includes a processor coupled to an accelerometer to receive signals and configured to process the signals to provide indications of one or more of patient activity, structural integrity, and structural movement relative to the implantation location.

[0566] 156. The medical device of embodiment 152, wherein one or more sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implantation site.

[0567] 157. The medical device of embodiment 152, wherein one or more sensors include stress sensors configured to output signals corresponding to motion, force, tension, velocity or other mechanical forces associated with a structure.

[0568] 158. The medical device of embodiment 157, wherein the electronics further includes a processor coupled to a stress sensor to receive signals from the stress sensor over time, and configured to process the signals to provide a characterization of the fracture, characterizing the healing state corresponding to the fracture.

[0569] 159. The medical device of embodiment 152, wherein one or more sensors include an ultrasonic transducer configured to output a signal corresponding to ultrasonic energy sensed in a structural region.

[0570] 160. The medical device of embodiment 159, wherein the electronics further includes a processor coupled to an ultrasound transducer to receive signals from the ultrasound transducer and configured to process the signals to provide one or more of the following: characterization of a fracture, characterization of tissue in a structural region, and glucose levels.

[0571] 161. The medical device of embodiment 152, wherein one or more sensors include one or more of a glucose detector and an oxygen sensor configured to output signals corresponding to one of a glucose level and an oxygen level, respectively.

[0572] 162. The medical device of embodiment 161, wherein the electronics further includes a processor coupled to one or more of a glucose detector and an oxygen sensor to receive signals and configured to process signals to provide an indication of inflammatory fluid in the area of ​​the medical device.

[0573] 163. The medical device of embodiment 109 further includes a mechanism configured to deliver a catalytic substance at the implantation site to generate gaseous oxygen through a chemical reaction.

[0574] 164. The medical device as described in embodiment 163, wherein the mechanism comprises one or more of the following:

[0575] A reservoir that releases catalysts once or multiple times after implantation under the control of a time-release controller; and

[0576] A coating of catalytic material on the structure.

[0577] 165. A medical device comprising:

[0578] A cannulation structure having a lumen extending therefrom, a plurality of holes through its sidewalls, and a plurality of electrodes associated with one of the plurality of holes, the cannulation structure being configured to be at least partially implanted in the body; and

[0579] An electronic box including electronic components, the electronic box being at least partially located within a cavity, and including a plurality of electrical contacts, each of the plurality of electrical contacts being aligned with an aperture to establish electrical coupling between the electronic components and each of the plurality of electrodes.

[0580] 166. The medical device as described in embodiment 165, wherein:

[0581] The cannulation structure includes a shaft.

[0582] Multiple holes include single sets of holes spaced apart along the length of the axis, and

[0583] Multiple electrodes include single groups of electrodes spaced apart along the length of the axis.

[0584] 167. The medical device as described in embodiment 165, wherein:

[0585] The cannulation structure includes a shaft.

[0586] The plurality of holes includes a first group of holes spaced apart along a first side of the shaft, and a second group of holes spaced apart along a second side spaced apart from the first side.

[0587] The plurality of electrodes includes a first group of electrodes spaced apart along a first side of the axis, and a second group of electrodes spaced apart along a second side spaced apart from the first side.

[0588] 168. The medical device as described in embodiment 165, wherein:

[0589] The cannulation structure includes a shaft.

[0590] The plurality of holes include a first linear slot at a first side of the shaft, and a second linear slot at a second side spaced apart from the first side, and

[0591] The plurality of electrodes includes a first linear electrode at a first side of the shaft and a second linear electrode at a second side spaced apart from the first side.

[0592] 169. The medical device as described in embodiment 165, wherein:

[0593] The cannulation structure includes a base with an outer surface and an inner surface, and

[0594] Multiple electrodes include:

[0595] A first electrode, located on the outer surface, has a feedthrough extending into the inner surface of the substrate through a first hole among a plurality of holes, and

[0596] The second electrode is on the outer surface and has a feedthrough extending into the inner surface of the substrate through a second hole among a plurality of holes.

[0597] 170. The medical device as described in embodiment 169, wherein the substrate comprises an electrically insulating material.

[0598] 171. The medical device of embodiment 169, wherein the substrate comprises a conductive material coated with an electrically insulating material.

[0599] 172. The medical device as described in embodiment 169, wherein the electronic box comprises:

[0600] The first electrical contact among multiple electrical contacts is positioned to provide a feedthrough to the first electrode on the inner surface of the contact substrate, thereby establishing electrical coupling between the electronic device and the first electrode; and

[0601] The second electrical contact of the multiple electrical contacts is positioned to feed through the second electrode on the inner surface of the contact substrate, thereby establishing electrical coupling between the electronic device and the second electrode.

[0602] 173. The medical device as described in embodiment 165, wherein the plurality of electrodes comprises:

[0603] A first conductive structure extending through the first hole in a plurality of holes; and

[0604] A second conductive structure extending into the inner surface of the body through the second of a plurality of holes.

[0605] 174. The medical device as described in embodiment 173, wherein the first conductive structure corresponds to the first conductive pin, and the second conductive structure corresponds to the second conductive pin.

[0606] 175. The medical device as described in embodiment 174, wherein each of the first conductive pin and the second conductive pin is a pogo-type pin normally biased outward from the first or second hole.

[0607] 176. The medical device of embodiment 173, wherein each of the first conductive structure and the second conductive structure corresponds to a conductive material filling the first or second hole.

[0608] 177. An implantable medical device for characterizing a fracture, the medical device comprising:

[0609] An implant configured to be at least partially implanted in the bone and span a fracture;

[0610] An impedance sensor, included in an implant and comprising:

[0611] First electrode and second electrode; and

[0612] A sensing module configured to obtain impedance measurements between the first electrode and the second electrode;

[0613] Includes a controller and memory implanted and configured to process and store impedance measurements; and

[0614] A communication circuit included in an implant and configured to transmit impedance measurements to an external device.

[0615] 178. The medical device of embodiment 177, wherein the sensing module is configured to enable the first electrode and the second electrode to function in an application mode or a sensing mode, wherein during the application mode, a signal is applied through the first electrode and the second electrode, and during the sensing mode, impedance is sensed between the first electrode and the second electrode.

[0616] 179. The medical device of embodiment 178, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0617] 180. The medical device as described in embodiment 177, wherein:

[0618] The impedance sensor also includes a third electrode and a fourth electrode; and

[0619] The sensing module is configured to implement an application mode and a sensing mode. In the application mode, signals are applied through the first and second electrodes, and in the sensing mode, impedance is sensed between the third and fourth electrodes.

[0620] 181. The medical device of embodiment 180, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0621] 182. The medical device of embodiment 177, wherein the controller is further configured to process impedance measurements over time to determine the characterization of the fracture, characterizing the healing state corresponding to the fracture.

[0622] 183. The medical device as described in embodiment 182, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0623] 184. The medical device of embodiment 177, wherein the first electrode and the second electrode are spaced apart on the implant to enable placement of the first electrode and the second electrode on opposite sides of the fracture.

[0624] 185. The medical device of embodiment 177, wherein the impedance sensor includes a plurality of electrodes, including a first electrode, a second electrode and at least one additional electrode, wherein the sensing module is configured to select the first electrode and the second electrode from the plurality of electrodes based on impedance measurement, such that the first electrode and the second electrode are on opposite sides of the fracture.

[0625] 186. The medical device of embodiment 177, wherein the communication circuitry includes a tissue conduction communication circuitry coupled to the first and second electrodes and configured to achieve capacitive coupling between the medical device and another device, or current coupling between the medical device and another device.

[0626] 187. The medical device as described in embodiment 177, wherein the implant comprises:

[0627] A structure having at least partially a lumen extending therefrom, and configured to be at least partially implanted in bone and through a fracture; and

[0628] An electronic cartridge, comprising at least a portion of an impedance sensor, a controller, a memory, and at least a portion of a communication circuit, is configured to be inserted into a lumen behind an implant structure.

[0629] 188. The medical device of embodiment 187, wherein the structure includes an outer surface and the first electrode and the second electrode are located on the outer surface.

[0630] 189. The medical device as described in embodiment 187, wherein:

[0631] The structure includes at least one hole through the sidewall; and

[0632] The electronic box includes an outer surface, and a first electrode and a second electrode are located on the outer surface and positioned aligned with at least one hole when the electronic box is inserted into the cavity of the structure.

[0633] 190. The medical device as described in embodiment 187, wherein the structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device, or other orthopedic device.

[0634] 191. The medical device as described in embodiment 177, wherein the implant comprises a single structure.

[0635] 192. The medical device as described in embodiment 191, wherein a single structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device, or other orthopedic device.

[0636] 193. Methods for characterizing fractures, including:

[0637] Multiple measurements of time-varying tissue electrical properties were obtained using multiple electrodes positioned within the bone tissue and spanning the fracture, including a first electrode and a second electrode on opposite sides of the fracture; and

[0638] The procedure involves measurements to determine the characterization of the fracture, which corresponds to the state of fracture healing;

[0639] Multiple measurements may be performed using the medical device described in any one of embodiments 1-192, 226-238, and 262-263.

[0640] 194. The method as described in embodiment 193, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0641] 195. The method of embodiment 193 further includes communicating multiple measurements of tissue electrical properties or characterization of fractures to an external device.

[0642] 196. The method of embodiment 193, wherein the electrical properties of the tissue include impedance, and obtaining multiple measurements includes:

[0643] Signals are applied to the first electrode at different frequencies to measure tissue impedance using electrical impedance spectrum (EIS) technology.

[0644] 197. The method of embodiment 196, wherein a signal is applied via an implanted sensing module.

[0645] 198. The method of embodiment 193 further includes implanting a plurality of electrodes to place the first electrode and the second electrode on opposite sides of the fracture.

[0646] 199. The method of embodiment 198, wherein implanting multiple electrodes comprises:

[0647] At least one cannulation structure is implanted into bone tissue and passed through a fracture, the cannulation structure having a lumen at least partially extending therethrough; and

[0648] After the cannula structure is implanted, an electronic box, which includes a sensing module, is inserted into the lumen.

[0649] 200. The method of embodiment 199, wherein a plurality of electrodes are carried by a cannulation structure and coupled to a sensing module after the electronic box is inserted into the lumen.

[0650] 201. The method as described in embodiment 199, wherein a plurality of electrodes are carried by an electronic cartridge and engage with bone tissue through a plurality of holes in the sidewall of the cannulation structure.

[0651] 202. The method of embodiment 199 further includes securing the electronic box to the insertion tube structure.

[0652] 203. The method of embodiment 198, wherein implanting multiple electrodes comprises:

[0653] An implantable medical device includes a structure carrying multiple electrodes and electronic devices positioned within the structure and coupled to the multiple electrodes.

[0654] 204. Methods for characterizing fractures, including:

[0655] Multiple measurements of the electrical properties of the tissue over time were obtained using multiple electrodes positioned within the bone tissue at the fracture site, including a first electrode and a second electrode, each located within the fracture gap; and

[0656] The procedure involves measurements to determine the characterization of the fracture, which corresponds to the state of fracture healing.

[0657] 205. The method as described in embodiment 204, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0658] 206. The method of embodiment 204 further includes communicating multiple measurements of tissue electrical properties or characterization of fractures to an external device.

[0659] 207. The method of embodiment 204, wherein the electrical properties of the tissue include impedance, and obtaining multiple measurements includes:

[0660] Signals are applied to the first electrode at different frequencies to measure tissue impedance using electrical impedance spectrum (EIS) technology.

[0661] 208. The method of embodiment 207, wherein the signal is applied via the implanted sensing module.

[0662] 209. The method of embodiment 204 further includes implanting a plurality of electrodes to place the first electrode and the second electrode in the gap of the fracture.

[0663] 210. The method of embodiment 209, wherein implanting multiple electrodes comprises:

[0664] At least one cannulation structure is implanted into bone tissue and spans the fracture gap, the cannulation structure having a lumen at least partially extending through it; and

[0665] After the cannula structure is implanted, an electronic box, which includes a sensing module, is inserted into the lumen.

[0666] 211. The method of embodiment 210, wherein a plurality of electrodes are carried by a cannulation structure and coupled to a sensing module after the electronic box is inserted into the lumen.

[0667] 212. The method of embodiment 210, wherein a plurality of electrodes are carried by an electronic box and engaged with bone tissue through a plurality of holes in the sidewall of the cannulation structure.

[0668] 213. The method of embodiment 210 further includes securing the electronic box to the insertion tube structure.

[0669] 214. The method of embodiment 209, wherein implanting multiple electrodes comprises:

[0670] An implantable medical device includes a structure carrying multiple electrodes and electronic devices positioned within the structure and coupled to the multiple electrodes.

[0671] 215. Methods for characterizing fractures, including:

[0672] Multiple measurements of time-varying tissue electrical properties were obtained using multiple electrodes positioned within the bone tissue at the fracture site, including a first electrode and a second electrode, each spanning the fracture gap; and

[0673] The procedure involves measurements to determine the characterization of the fracture, which corresponds to the state of fracture healing;

[0674] Multiple measurements may be performed using the medical device described in any one of embodiments 1-192, 226-238, and 262-263.

[0675] 216. The method as described in embodiment 215, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0676] 217. The method of embodiment 215 further includes communicating multiple measurements of tissue electrical properties or characterization of fractures to an external device.

[0677] 218. The method of embodiment 215, wherein the electrical properties of the tissue include impedance, and obtaining multiple measurements includes:

[0678] Signals are applied to the first electrode at different frequencies to measure tissue impedance using electrical impedance spectrum (EIS) technology.

[0679] 219. The method as described in 218, wherein the signal is applied via an implanted sensing module.

[0680] 220. The method of embodiment 215 further includes implanting a plurality of electrodes to place a first electrode and a second electrode across the fracture gap.

[0681] 221. The method of embodiment 220, wherein implanting multiple electrodes comprises:

[0682] At least one cannulation structure is implanted into bone tissue and spans the fracture gap, the cannulation structure having a lumen at least partially extending through it; and

[0683] After the cannula structure is implanted, an electronic box, which includes a sensing module, is inserted into the lumen.

[0684] 222. The method of embodiment 221, wherein a plurality of electrodes are carried by a cannulation structure and coupled to a sensing module after the electronic box is inserted into the lumen.

[0685] 223. The method of embodiment 221, wherein a plurality of electrodes are carried by an electronic box and engaged with bone tissue through a plurality of holes in the sidewall of the cannulation structure.

[0686] 224. The method of embodiment 221 further includes securing the electronic box to the insertion tube structure.

[0687] 225. The method of embodiment 220, wherein implanting multiple electrodes comprises:

[0688] An implantable medical device includes a structure carrying multiple electrodes and electronic devices positioned within the structure and coupled to the multiple electrodes.

[0689] 226. An implantable medical device for characterizing fractures in bone, the medical device comprising:

[0690] A first implant configured to be at least partially implanted in bone, the first implant having a first electrode;

[0691] A second implant configured to be at least partially implanted in bone, the second implant having a second electrode;

[0692] The third implant is configured to cross the fracture and be placed on the bone and fixed in place by the first and second implants;

[0693] An impedance sensor consists of the following components:

[0694] First electrode and second electrode; and

[0695] A sensing module, included in one of the first, second, or third implants, and configured to obtain an impedance measurement between the first electrode and the second electrode;

[0696] A controller and a memory, included in one of the first, second, or third implants, and configured to process and store impedance measurements; and

[0697] A communication circuit, included in one of the first, second, or third implants, and configured to transmit impedance measurements to an external device.

[0698] 227. The medical device of embodiment 226, wherein the third implant is configured to allow coupling of the first implant and the second implant along the third implant at locations where the first electrode and the second electrode are placed on opposite sides of the fracture.

[0699] 228. The medical device of embodiment 226, wherein the sensing module is configured to enable the first electrode and the second electrode to function in an application mode or a sensing mode, to apply a signal through the first electrode and the second electrode during the application mode, and to sense the impedance between the first electrode and the second electrode during the sensing mode.

[0700] 229. The medical device of embodiment 228, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

[0701] 230. The medical device of embodiment 226, wherein the controller is further configured to process impedance measurements over time to determine the characterization of the fracture, characterizing the healing state corresponding to the fracture.

[0702] 231. The medical device as described in embodiment 230, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

[0703] 232. The medical device of embodiment 226, wherein the communication circuit includes a tissue conduction communication circuit coupled to the first electrode and the second electrode and configured to enable capacitive coupling between the medical device and another device, or to enable current coupling between the medical device and another device.

[0704] 233. The medical device of embodiment 226, wherein at least one of the first implant and the second implant comprises:

[0705] A structure having at least partially a lumen extending from it, and configured to at least partially implant in bone and cross a fracture; and

[0706] An electronic cartridge, comprising at least a portion of an impedance sensor, a controller, a memory, and at least a portion of a communication circuit, is configured to be inserted into a lumen behind an implant structure.

[0707] 234. The medical device of embodiment 233, wherein the structure includes an outer surface and the first electrode or the second electrode is located on the outer surface.

[0708] 235. The medical device as described in embodiment 233, wherein:

[0709] The structure includes at least one hole through the sidewall; and

[0710] The electronic box includes an outer surface, and a first electrode or a second electrode is located on the outer surface and positioned to align with at least one hole when the electronic box is inserted into the cavity of the structure.

[0711] 236. The medical device as described in embodiment 233, wherein the structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device, or other orthopedic device.

[0712] 237. The medical device of embodiment 228, wherein at least one of the first implant and the second implant comprises a single structure.

[0713] 238. The medical device of embodiment 237, wherein a single structure is part of a screw, pin, rod, nail, joint replacement implant, spinal fixation device, or other orthopedic device.

[0714] 239. A method for manufacturing an implantable medical device, the method comprising:

[0715] Multiple holes are created through the sidewalls of a cannulation structure configured to be at least partially implanted in the body and having a lumen extending therethrough;

[0716] Associate the electrode with each of the multiple holes; and

[0717] The electronic box is associated with the lumen of the cannulation structure. The electronic box includes electronic components and multiple electrical contacts, wherein the association aligns each of the multiple electrical contacts with one of the holes to establish electrical coupling between the electronic components and each electrode.

[0718] The medical device optionally manufactured is the medical device described in any one of embodiments 1-192, 226-238 and 262-263.

[0719] 240. The method of embodiment 239, wherein the cannulation structure includes a conductive material, and associating the electrode with each of the plurality of holes includes:

[0720] Apply an electrically insulating material to the cannulation structure in each of the multiple holes; and

[0721] In each of the multiple holes, a conductive material is applied to the electrically insulating material.

[0722] 241. The method of embodiment 239, wherein the cannulation structure includes an electrically insulating material, and associating the electrode with each of the plurality of holes includes:

[0723] In each of the multiple holes, a conductive material is applied to the surface of the cannula structure.

[0724] 242. The method of embodiment 239, wherein the cannulation structure includes a conductive material, and associating the electrode with each of the plurality of holes includes:

[0725] In each of the multiple holes, an electrically insulating material is applied to the cannulation structure; and

[0726] A conductive structure is placed through each of the multiple holes.

[0727] 243. The method of embodiment 242, wherein placing the conductive structure includes inserting a conductive pin through each of the plurality of holes.

[0728] 244. The method of embodiment 242, wherein placing the conductive structure includes filling each of the plurality of holes with a conductive material.

[0729] 245. The method of embodiment 239, wherein the cannulation structure includes an electrically insulating material, and associating the electrode with each of the plurality of holes includes at least one of the following:

[0730] Insert a conductive pin through each of the multiple holes; and

[0731] Each of the multiple holes is filled with a conductive material.

[0732] 246. A method for implanting a medical device, the method comprising:

[0733] An implantable structure is at least partially implanted into the body, the implantable structure having a lumen extending at least partially through it; and

[0734] After the implant structure is implanted, the electronic box is inserted into the lumen.

[0735] 247. The method of embodiment 246, wherein the implant structure includes a proximal end having a head, and an axis extending from the head toward the distal end of the implant structure, and the implant structure includes:

[0736] A support structure is inserted into the shaft and at least partially along the length of the lumen; and

[0737] The supporting structure rotates together with the implant structure.

[0738] 248. The method of embodiment 247, wherein rotating the support structure together with the implant structure includes transmitting rotational torque from the support structure to a portion of the shaft.

[0739] 249. The method as described in embodiment 248, wherein the shaft and support structure are configured to be mechanically coupled to enable direct transmission of rotational torque to the shaft.

[0740] 250. The method of embodiment 247 further includes placing the implant structure on the guidewire across the fracture placement before inserting the support structure.

[0741] 251. The method of embodiment 246, wherein the implant structure includes a proximal end having a head and an axis extending from the head toward the distal end of the implant structure, and the implant structure includes:

[0742] The implant structure is placed in a coupling device, including a body configured to establish mechanical coupling with the distal portion of the implant structure; and

[0743] Rotational coupling device that rotates together with the implant structure.

[0744] 252. The method of embodiment 251, wherein the rotational coupling device together with the implant structure includes transmitting rotational torque along the length of the body to the mechanical coupling and the distal portion of the implant structure.

[0745] 253. The method of embodiment 252, wherein the coupling device is coupled to the implant structure only at the distal portion of the implant structure.

[0746] 254. The method of embodiment 246 further includes securing the electronic box to the implant structure.

[0747] 255. The method as described in embodiment 254 further includes:

[0748] After the electronic cartridge is secured to the implant structure, it is removed from the lumen without affecting the structural integrity of the implant structure or the electronic cartridge.

[0749] 256. The method as described in embodiment 255 further includes:

[0750] After removing the electron cartridge from the lumen, a replacement electron cartridge is inserted into the lumen of the implant structure.

[0751] 257. An instrument for implanting an implant structure having a proximal end including a head, an axis extending from the head toward a distal end of the implant structure, and a lumen extending through the axis, the instrument comprising:

[0752] Drill bit; and

[0753] A mechanism used to apply rotational torque to the drill bit.

[0754] The drill bit includes:

[0755] The first part is configured to be directly coupled to the head of the implant structure; and

[0756] A second portion extending from the first portion, the second portion being configured to extend at least partially into the lumen of the implant structure.

[0757] 258. The tool as described in embodiment 257, wherein the second portion includes a mechanical feature configured to mechanically couple with a corresponding feature of the shaft, thereby enabling the transmission of rotational torque from the second portion to the shaft.

[0758] 259. A coupling device for implanting an implant structure having a proximal end including a head and an axis extending from the head toward a distal end of the implant structure, the coupling device comprising:

[0759] A main body having a proximal region and a distal region configured to establish mechanical coupling with the distal portion of the implant structure; and

[0760] A cap configured to be coupled to the proximal region of the body rather than directly to the implant structure.

[0761] 260. The coupling device as described in embodiment 259, wherein:

[0762] The cap is configured to couple with the tool, receive rotational torque from the tool via coupling, and transmit rotational torque along the length of the body to the distal portion of the mechanical coupling and implant structure.

[0763] 261. The coupling device as described in embodiment 259, wherein the coupling device is configured to be coupled to the implant structure only at the distal portion of the implant structure.

[0764] 262. The medical device as described in any one of embodiments 1-192 and 226-238, wherein the medical device is sterile.

[0765] 263. The medical device as described in any one of embodiments 1-192 and 226-238, wherein the medical device has undergone a sterilization process to provide a sterile medical device.

[0766] 264. A method for treating fractures in bone tissue, comprising identifying the fracture in bone tissue and inserting a medical device according to any one of embodiments 1-192, 226-238 and 262-263 into the bone tissue, wherein the medical device is inserted across the fracture.

[0767] 265. The method of embodiment 264, wherein the medical device is any one of embodiments 1-76.

[0768] 266. The method of embodiment 264, wherein the medical device is any one of embodiments 77-94.

[0769] 267. The method of embodiment 264, wherein the medical device is any one of embodiments 95-101.

[0770] 268. The method of embodiment 264, wherein the medical device is any one of embodiments 102-104.

[0771] 269. The method of embodiment 264, wherein the medical device is any one of embodiments 105-108.

[0772] 270. The method of embodiment 264, wherein the medical device is any one of embodiments 109-164.

[0773] 271. The method of embodiment 264, wherein the medical device is any one of embodiments 165-176.

[0774] 272. The method of embodiment 264, wherein the medical device is any one of embodiments 177-192.

[0775] 273. The method of embodiment 264, wherein the medical device is any one of embodiments 226-238.

[0776] 274. The method of embodiment 264, wherein the medical device is any one of embodiments 262-263.

[0777] 275. The method as described in any one of embodiments 264-274, wherein the medical device is a screw.

[0778] 276. The method as described in any one of embodiments 264-275 further includes characterizing the portion using a medical device.

[0779] 277. A method for characterizing fractures in bone tissue, the method comprising identifying fractures in bone tissue, inserting a medical device according to any one of embodiments 1-192, 226-238 and 262-263 into the bone tissue, wherein the medical device...

Claims

1. A medical device, comprising: A structure having at least a lumen extending through it and configured to be at least partially implanted in the body; An electronic box, which includes electronic components and is configured to be inserted into the lumen after implantation into the structure; and A sensor for measuring the electrical properties of tissue, the sensor including a plurality of electrodes and a sensing module of the electronic box, the sensing module being coupled to the plurality of electrodes, wherein the plurality of electrodes includes a first electrode and a second electrode; Furthermore, the sensing module is configured to enable the first electrode and the second electrode to operate in either an application mode or a sensing mode, applying a signal through the electrodes during the application mode and sensing the impedance between the electrodes during the sensing mode. in: The plurality of electrodes are located on the outer surface of the structure and spaced apart, allowing the placement of the first and second electrodes on opposite sides of the fracture; and the electronic box includes a plurality of electrical contacts positioned on the outer surface of the electronic box and spaced apart, for electrical coupling with the plurality of electrodes when the electronic box is inserted into the lumen of the structure. Alternatively, the structure includes at least one hole through the sidewall, and the plurality of electrodes are positioned on the outer surface of the electronic box and spaced apart, so as to enable the placement of the first and second electrodes on opposite sides of the fracture, and to enable alignment between the plurality of electrodes and the plurality of holes when the electronic box is inserted into the lumen of the structure.

2. The medical device of claim 1, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

3. The medical device as claimed in claim 1, wherein: The sensor also includes an electrode switch; The plurality of electrodes includes a first electrode, a second electrode, a third electrode, and a fourth electrode that are switchably coupled to the sensing module via the electrode switch; and The sensing module is configured to implement an application mode and a sensing mode, during which signals are applied through the first electrode and the second electrode, and during the sensing mode, the impedance between the third electrode and the fourth electrode is sensed.

4. The medical device of claim 3, wherein the sensing module includes a signal generator configured to apply signals at different frequencies to measure tissue impedance according to electrical impedance spectrum (EIS) technology.

5. The medical device of claim 1, wherein the electrical properties of the tissue include impedance measurement, and further includes a controller configured to process the impedance measurement over time to determine a fracture characterization corresponding to the healing state of the fracture.

6. The medical device of claim 5, wherein the healing state corresponds to one of healing, possibly non-healing, and non-healing.

7. The medical device of claim 1, wherein: The structure includes at least one hole through the sidewall; and The plurality of electrodes are positioned on the electronic box to be aligned with the at least one hole when the electronic box is inserted into the cavity of the structure.

8. The medical device of claim 1, wherein: The structure includes a distal opening and a proximal opening; and The plurality of electrodes includes a first electrode positioned on the electronic box and a second electrode positioned on the electronic box, wherein the first electrode is adjacent to the distal opening when the electronic box is inserted into the lumen of the structure, and the second electrode is adjacent to the proximal opening when the electronic box is inserted into the lumen of the structure.

9. The medical device of claim 1, wherein: The structure includes a distal opening; and The plurality of electrodes includes a first electrode and a second electrode, each positioned on the electronic box to be positioned at the distal end of the distal opening of the structure when the electronic box is inserted into the lumen of the structure.

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

11. The medical device of claim 10, wherein the structure includes a head having a recessed pocket defining a lumen head portion, the lumen being configured to receive a portion of the implantation tool to enable the transmission of torque applied to the implantation tool to the structure.

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

13. The medical device of claim 12, wherein the structure is configured for implantation to bridge fractures.

14. The medical device of claim 12, wherein the structure is configured for implantation through a hole in a plate bridging a fracture.

15. The medical device of claim 1, wherein the structure is part of a screw, pin, rod, nail, joint replacement implant, or spinal fixation device.

16. The medical device of claim 1, wherein the structure includes a shaft having an outer diameter of 4 mm or greater.

17. The medical device of claim 1, wherein the lumen includes a shaft portion having a diameter sized to receive at least a portion of the electronic cartridge.

18. The medical device of claim 1, wherein each of the electronic box and the lumen has substantially the same shape factor.

19. The medical device of claim 18, wherein the shape factors of the electronic box and the lumen respectively include a head portion and a shaft portion, wherein the head portion has a diameter larger than that of the shaft portion.

20. The medical device of claim 1, wherein the structure and the electronic box include mechanical features that enable the electronic box to be securely fastened within the lumen.

21. The medical device of claim 20, wherein the mechanical features include one of the following: a difference in shape factor between the head of the electronic cartridge and the head portion of the lumen of the structure; a protrusion associated with the electronic cartridge and a recess associated with the lumen of the structure; and an interlocking feature associated with the axis of the electronic cartridge for receiving a crosslinking agent and an inner wall of the structure for engaging the crosslinking agent.

22. The medical device of claim 1, wherein the structure and the electronic cartridge include mechanical features that enable the removal of the electronic cartridge from the lumen without compromising the structural integrity of the electronic cartridge or the structure.

23. The medical device of claim 22, wherein the mechanical features include complementary threads.

24. The medical device of claim 1, wherein the electronic box includes a head and a shaft, and at least a portion of the electronic components are included in an electronic assembly located in the head.

25. The medical device of claim 1, wherein the electronic box includes a head and a shaft, and at least a portion of the electronic components are included in an electronic assembly located in the shaft.

26. The medical device of claim 1, wherein the electronic component includes an antenna.

27. The medical device of claim 26, wherein: The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and The antenna is associated with the axis.

28. The medical device of claim 27, wherein the antenna comprises a conductive line or trace extending along the length of the axis.

29. The medical device of claim 28, wherein the antenna extends about the axis in a helical pattern.

30. The medical device of claim 29, wherein the antenna is electrically insulated from the outer surface of the shaft to avoid contact with the structure when the electronics box is inserted into the lumen of the structure.

31. The medical device of claim 26, wherein: The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and The antenna is associated with the head.

32. The medical device of claim 31, wherein the antenna comprises a conductive line or trace extending along a plane parallel to the bottom of the head.

33. The medical device of claim 1, wherein the electronic device comprises one or more power sources.

34. The medical device of claim 33, wherein: The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and The one or more energy sources are associated with the shaft.

35. The medical device of claim 33, wherein: The electronic box includes a proximal end, a distal end, a head at the proximal end, and an axis extending from the head to the distal end; and The one or more energy sources are associated with the head.

36. The medical device of claim 33, wherein the one or more power sources include one or more of batteries and capacitors.

37. The medical device of claim 33, wherein the one or more energy sources include an energy harvesting device configured to harvest energy via electrostatic energy, wireless power transfer, electromechanical conversion, electromagnetic conversion, and IR radiation.

38. The medical device of claim 1, wherein the electronic device includes one or more communication components capable of communicating between the medical device and another device implanted in or outside the body.

39. The medical device of claim 38, wherein the one or more communication components comprise: antenna; and A radio frequency (RF) transceiver, which is coupled to the antenna and configured to receive and transmit RF signals.

40. The medical device of claim 38, wherein the one or more communication components comprise: A transmitter coupled to an electrode associated with the medical device and configured and positioned in contact with tissue; and A receiver, which is coupled to an electrode associated with the medical device and configured and positioned to contact tissue.

41. The medical device of claim 38, wherein the one or more communication components are configured to perform at least one of the following: To achieve capacitive coupling between the medical device and another device; or To achieve current coupling between the medical device and another device.

42. The medical device of claim 1, wherein the electronic device comprises one or more sensors.

43. The medical device of claim 42, wherein the one or more sensors include an accelerometer configured to output a signal corresponding to motion of the structure.

44. The medical device of claim 43, wherein the accelerometer comprises one of a one-dimensional accelerometer and a three-dimensional accelerometer.

45. The medical device of claim 43, wherein the electronics further comprises a processor coupled to the accelerometer to receive the signal and configured to process the signal to provide indications of one or more of patient activity, structural integrity, and movement of the structure relative to the implantation site.

46. ​​The medical device of claim 42, wherein the one or more sensors include a temperature sensor configured to output a signal corresponding to the temperature of the structure at the implantation site.

47. The medical device of claim 42, wherein the one or more sensors include a stress sensor configured to output a signal corresponding to motion, force, tension, velocity or other mechanical force associated with the structure.

48. The medical device of claim 47, wherein the electronics further comprises a processor coupled to the stress sensor to receive signals from the stress sensor over time, and configured to process the signals to provide a characterization of the fracture, the characterization corresponding to the healing state of the fracture.

49. The medical device of claim 42, wherein the one or more sensors include an ultrasonic transducer configured to output an ultrasonic energy signal corresponding to a region of the structure.

50. The medical device of claim 49, wherein the electronics further comprises a processor coupled to the ultrasound transducer to receive signals from the ultrasound transducer and configured to process the signals to provide one or more of the following: characterization of a fracture, characterization of tissue in a region of the structure, and glucose in a healing region.

51. The medical device of claim 42, wherein the one or more sensors include one or more of a glucose detector and an oxygen sensor configured to output signals corresponding to one of a glucose level and an oxygen level, respectively.

52. The medical device of claim 51, wherein the electronics further comprises a processor coupled to one or more of the glucose detector and oxygen sensor to receive the signal, and configured to process the signal to provide an indication of inflammatory fluid in a region of the medical device.

53. The medical device of claim 1, wherein the electronic box further includes a mechanism configured to deliver a catalyst that generates gaseous oxygen at the implantation site through a chemical reaction.

54. The medical device of claim 53, wherein the mechanism comprises one or more of the following: A reservoir that, under the control of a time-release controller, releases the catalyst once or multiple times after implantation; and The electronic box has a catalytic coating.

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