Devices, systems, and methods for using and monitoring medical devices

Abstract

The invention relates to devices, systems, and methods for using and monitoring medical devices. A medical device is provided, including a medical device and a sensor.

Description

[0001] This application is a divisional application of the application filed on September 17, 2015, with application number 201580060791.X, entitled "Equipment, System and Method for Using and Monitoring Medical Devices". Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 051,855, filed September 17, 2014, and U.S. Provisional Patent Application No. 62 / 184,820, filed June 25, 2015, pursuant to 35 USC §119(e), which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention generally relates to medical devices, and more specifically to apparatus and methods for monitoring the placement, efficacy, durability and performance of a wide variety of temporary and / or permanent implantable medical devices. background

[0004] Medical devices and implants have become ubiquitous in modern medicine. Typically, medical devices and implants are manufactured to replace, support, or enhance anatomical or biological structures. Examples of medical devices include: cardiovascular implants such as implantable cardioverter defibrillators, pacemakers, stents, stent grafts, bypass grafts, catheters, and heart valves; orthopedic implants such as hip and knee prostheses; spinal implants and hardware (spinal cages, screws, plates, pins, rods, and artificial intervertebral discs); intrauterine devices; orthopedic hardware for repairing fractures and soft tissue injuries (plaster casts, braces, tensor bandages, plates, screws, pins, and plates); cochlear implants; aesthetic implants (breast implants, fillers); dental implants: medical polymers; and artificial intraocular lenses.

[0005] Unfortunately, various complications can occur during the insertion of medical devices or implants, whether in open or minimally invasive procedures. For example, surgeons may want to confirm the correct anatomical alignment and placement of the implant within the surrounding tissues and structures. However, this can be difficult to achieve during the procedure itself, making adjustments challenging.

[0006] In addition, patients may experience multiple complications after surgery. Such complications include neurological symptoms, pain, functional impairment (blockage, loosening, etc.) and / or wear and tear of the implant, implant displacement or breakage, inflammation and / or infection. While some of these problems can be addressed with pharmaceutical products and / or further surgery, they are difficult to predict and prevent; early identification of complications and side effects is often difficult or impossible.

[0007] All topics discussed in the background section are not necessarily prior art and should not be assumed to be prior art simply because they are discussed in the background section. Following these lines, any awareness of problems in the prior art discussed in the background section or associated with such topics should not be considered prior art unless explicitly stated otherwise. Rather, the discussion of any topic in the background section should be considered part of the inventor's method for a particular problem, which may itself be inventive. Overview

[0008] In short, medical devices and implants (also referred to as "medical devices") are provided, comprising a medical device and one or more ISMs ("implantable sensor modules") that can be used to monitor the integrity and effectiveness of the medical device. This invention discloses novel medical devices and implants that overcome many difficulties and limitations found in prior medical devices and implants, methods for constructing and monitoring these novel medical devices and implants, and also provides other related advantages.

[0009] Representative examples of medical devices and implants include, for example, cardiovascular devices and implants such as implantable cardioverter defibrillators, pacemakers, stents, stent grafts, bypass grafts, catheters, and heart valves; orthopedic implants such as hip and knee prostheses; spinal implants and hardware (spinal cages, screws, plates, pins, rods, and artificial intervertebral discs); a wide variety of medical tubes, cosmetic and / or aesthetic implants (e.g., breast implants, fillers); a wide variety of polymers; intrauterine devices; orthopedic hardware (e.g., plaster casts, braces, tensor bandages, external fixation devices, stretchers, slings, and supports) and internal hardware (e.g., K-wires, pins, screws, plates, and intramedullary devices (e.g., rods and nails)); cochlear implants; dental implants; medical polymers; a wide variety of neurological devices; and artificial intraocular lenses.

[0010] ISMs can be located inside a medical device, within the body of the medical device, or on the outer / inner surface (or surface) of the medical device, and / or between the medical device and any device that can be used to deliver implants and, if applicable, adhesives, sutures, and glues used in surgical procedures. In some embodiments, the sensors are passive and therefore do not require their own power source.

[0011] In one embodiment of the invention, the ISM is a self-contained module having one or more sensors, sensor interfaces, processor interfaces, battery management, and wireless interfaces as described herein. In a preferred embodiment of the invention, the size of the ISM will be less than 5, 4, 3, 2, or 1 cubic centimeter, and more preferably, its size will be less than 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, or 0.1 cubic centimeters. In various embodiments, the ISM may consist of a solid outer core or a flexible material (e.g., a biodegradable or non-biodegradable outer polymer surface). In some embodiments, the ISM may be relatively square and solid, while in other embodiments it may be very thin, stretchable, and long (compared to its width and / or height). The ISM can be configured for a variety of different applications (e.g., for insertion or implantation into any medical device or implant provided herein).

[0012] ISMs can also be used in delivery devices associated with or used with medical devices and implants. Representative examples include drill bits, drill guides, hammers, guidewires, catheters, balloons, cannulas, endoscopes, bone tunneling catheters, microsurgical instruments, and general surgical instruments.

[0013] In addition, other components or compositions may be delivered with medical devices and implants that may also have or contain ISM, including, for example, fillers such as sutures, glues, collagen, fibrin, growth factors, barriers, hemostatic agents, bone bonding agents, and polymers (such as PMMA).

[0014] In the preferred embodiments described above, the ISM, medical device, medical delivery device, and filler are all provided in a sterile (e.g., ETO-sterilized), pyrogen-free form suitable for use in humans and in kits containing components suitable for specific surgical procedures. In other embodiments, one or more components may be provided together as a kit.

[0015] Representative examples of sensors that can be included within an ISM and are suitable for use in this invention include accelerometers (accelerometers, tilt sensors, vibration sensors, shock sensors, and rotation sensors), pressure sensors, contact sensors, positioning sensors, chemical sensors, tissue metabolism sensors, mechanical stress sensors, auditory sensors, and temperature sensors. In a particularly preferred embodiment, the sensor is a wireless sensor or a sensor connected to a wireless microprocessor. In other embodiments, the medical device, delivery device, or surgical instrument may have more than one type of sensor described above.

[0016] According to various embodiments, sensors can be placed in ISMs at different locations to monitor surgery, movement, anatomical position, medical imaging (of both the medical device and surrounding tissues), function, physical integrity, wear, performance, potential side effects, the patient's medical status, the medical device's medical status, and its interface with the patient's living tissue. Real-time, continuous, or intermittent in-situ monitoring of patient activity, patient function, medical device activity, medical device function, medical device performance, medical device placement, medical device forces and mechanical stresses, the anatomy (imaging) of the medical device and surrounding tissues, the mechanical integrity, functional integrity, and physical integrity of the medical device, as well as potential local and systemic side effects, is provided. Furthermore, the information can be used on many aspects of the medical device and its interaction with the patient's own body tissues, including clinically important measurements that are not currently available through physical examination, medical imaging, and diagnostic medical research.

[0017] According to one embodiment, the ISM has one or more sensors to provide assessment data on any movement or motion of the medical device. Motion sensors and accelerometers can be used to accurately determine the movement of the medical device and to determine whether movement exists between the device and surrounding tissues (e.g., bone, blood vessels, soft tissue, organs). Such assessments can help reduce the incidence of improper placement, alignment, and deployment during surgical placement; the incidence of migration / breakage / wear during postoperative medical and physical examinations; and the incidence of functional impairment or side effects during normal daily activities after the patient returns home.

[0018] According to another embodiment, an ISM with a contact sensor is positioned between the medical device and the implant, and surrounding tissue, and / or between the hinged parts of the device / implant itself (e.g., in the case of orthopedic devices or implants, stent grafts, overlapping stents, heart valves, etc.). In other embodiments, a vibration sensor is provided to detect vibration between the medical device and / or surrounding tissue. In other embodiments, an ISM with a strain gauge is provided to detect strain between the medical device and surrounding tissue, and / or between the hinged parts of the device / implant itself (e.g., in the case of orthopedic devices, stent grafts, multiple stents, heart valves, etc.). A sudden increase in strain can indicate that too much stress is being placed on the medical device, which may increase the risk of injury to the body and / or breakage, cracking, and / or damage to the device.

[0019] According to other embodiments, an accelerometer is disposed within the ISM that detects vibrations, shocks, tilts, and rotations of the device / implant and extends to detect the surrounding tissue itself. According to other embodiments, sensors for measuring surface wear, such as contact or pressure sensors, are disposed within the ISM, which may be embedded at different depths within the medical device to monitor contact between the medical device and surrounding tissue or (e.g., in the context of biodegradable or bioerodible implants and devices, or in the context of surfaces subjected to repeated friction or wear, such as joint surfaces or heart valve leaflets) the degradation of the medical device over time. In other embodiments, the ISM is provided with positioning sensors and other types of sensors that indicate potential problems, such as movement, migration, pressure on surrounding anatomy, alignment, breakage, cracking, and / or bending of the medical device in actual use over a period of time.

[0020] In another embodiment, the medical device may include one or more ISMs having sensors at a specified density at a particular location. For example, the medical device may have a sensor density of more than one, two, three, four, five, six, seven, eight, nine, or ten sensors per square centimeter of device / implant [e.g., accelerometers (accelerometers, tilt sensors, vibration sensors, impact sensors, and rotation sensors), pressure sensors, contact sensors, positioning sensors, chemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors, or any combination thereof]. In other embodiments, the medical device may have a sensor density of more than one, two, three, four, five, six, seven, eight, nine, or ten sensors per cubic centimeter of device [e.g., accelerometers (accelerometers, tilt sensors, vibration sensors, impact sensors, and rotation sensors), pressure sensors, contact sensors, positioning sensors, chemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors, or any combination thereof].

[0021] In some embodiments of the invention, the medical device is assigned a specific unique identifier, and in other embodiments, each ISM and / or each sensor on, within, or around the medical device has a specific unique identifier or group identifier [e.g., identifiers for sensors as accelerometers (accelerometers, tilt sensors, vibration sensors, impact sensors, and rotation sensors), pressure sensors, contact sensors, positioning sensors, chemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors]. In still other embodiments, the specific unique identifier or group identifier is specifically associated with a location on, within, or around the medical device.

[0022] In other aspects of the invention, a method for monitoring an anatomically implanted medical device is provided, comprising the steps of: transmitting a radio signal from an external location to an internal location; receiving the signal at a sensor located on or around the medical device located internally; powering the sensor with the received signal; sensing data at the sensor; and outputting the sensed data from the sensor to a receiving unit located externally.

[0023] In another aspect of the invention, a method for monitoring an anatomically implanted medical device is provided, comprising the steps of: transmitting a radio signal from an external location to an internal location; receiving the signal at an ISM implanted in or within the medical device located within the body; sensing data at a sensor; and outputting the sensed data to an external location. In one embodiment, the sensed data may be output to an external location via an additional implantable module that does not contain a sensor or is designed to coordinate and distribute the sensed data among one or more ISMs.

[0024] In relevant aspects of the invention, a subject may have more than one implanted ISM. Furthermore, the multiple ISMs can be "connected" because they can be designed to communicate with each other and perform different functions. For example, in one aspect of the invention, a method for monitoring two or more anatomically implanted medical devices is provided, comprising the steps of: transmitting a radio signal from an external location to an internal location; receiving the signal at one of a plurality of ISMs implanted on or within the medical device located within the body; receiving the signal at an ISM implanted on or within the medical device located within the body; processing the signal and transmitting it to one or more other ISMs implanted on or within the medical device located within the body; sensing data at sensors in one or more other ISMs; and outputting the sensed data from one or more other ISMs to one of the multiple ISMs; processing the data received from one or more other ISMs; and outputting the processed data to a receiving unit located externally. In various embodiments, one of the multiple ISMs receiving the signal from externally may not necessarily include a sensor, or may not be used to provide sensor data, but rather for example, signal processing. In other embodiments, the implantable module may be used solely for receiving, transmitting, and / or storing signals. Such an implantable module can be used to coordinate signals within the subject and transmit those signals to a location outside the subject.

[0025] In other aspects of the invention, a method for imaging a medical device as provided herein is provided, comprising the steps of: (a) detecting the position of one or more ISMs having sensors therein or on the medical device, any associated anatomical or radiographic “landmarks” and / or associated medical delivery devices or surgical instruments; and (b) visually displaying the relative anatomical position of the one or more ISMs having one or more sensors, such that an image of the medical device is created. In various embodiments, the detection step may be performed over time, and thus the visual display may show positional movement over time. In some preferred embodiments, the image displayed is a three-dimensional image.

[0026] The imaging techniques presented herein can be used for a wide variety of purposes. For example, in one aspect, the imaging techniques can be used during surgical procedures to ensure proper anatomical placement, alignment, deployment, and function of medical devices. Proper alignment and movement are particularly critical in orthopedic reconstructive surgery (joint replacement), while proper alignment and fixation of bone fragments are key to achieving good results in trauma surgery and fracture reduction; therefore, allowing surgeons (especially in procedures where direct visualization is not possible) to see the position of the 'implant' "in real time" will facilitate proper anatomical placement, alignment, and fixation. In other embodiments, the imaging techniques can be used postoperatively to examine medical devices, examine interfaces with surrounding tissues, and / or compare the operation, integrity, alignment, and / or movement of the device / implant over time.

[0027] The integrity of a medical device can be wirelessly queried, and results reported periodically. This allows a patient's health and condition to be checked periodically or at any time desired by the patient and / or physician. Furthermore, when a medical device is signaled by the patient (via an externally signaling / triggered device) as part of an "event log," it can be wirelessly queried—that is, when the patient experiences a specific event (e.g., pain, injury, instability, etc.), she / he signals / triggers the device / implant to obtain simultaneous readings, allowing for comparison of subjective / symptom data with objective / sensor data. Matching the event log data with sensor data can be used as part of an effort to better understand the root cause of a patient's specific symptoms or a specific trigger. Therefore, in various embodiments of the invention, methods are provided for detecting and / or recording events in a subject using one of the medical devices provided herein, including querying one of the ISMs (Integrated Sensors) on the medical device as provided herein at a desired time. In one aspect of the invention, a method is provided for detecting and / or recording events in a subject using a medical device as provided herein, comprising the steps of: querying the activity of one or more ISMs having sensors within the medical device at a desired time, and recording said activity. In various embodiments, the inquiry may be performed by the subject and / or by a healthcare professional. In related embodiments, the recording steps may be performed using one or more wired devices or wireless devices that can be carried or worn (e.g., mobile phones, watches or wristbands, shoes and / or glasses).

[0028] In other aspects of the invention, methods and apparatus are provided adapted to transmit radio signals from an external location to an internal location; receive the signal at one of the aforementioned sensors located on, therein, or around a medical device located internally; power the sensor using the received signal; sense data at the sensor; and output the sensed data from the sensor to a receiving unit located externally. In some embodiments, the receiving unit may provide analysis of the signals provided by the sensor.

[0029] Data collected by sensors can be stored in memory located within the ISM, on the medical device, or on an associated device (e.g., an associated medical device or external device such as a mobile phone, watch, wristband, and / or glasses). During a physician visit, the data can be downloaded via wireless sensors, and the physician can obtain data representing the real-time performance of the medical implant and any associated medical devices.

[0030] The advantages gained include more accurate monitoring of medical devices and permission for medical reports to provide accurate, in-situ data that contributes to patient health. Details of one or more embodiments are set forth in the following description. Other features, objects, and advantages will become apparent from the description, drawings, and claims. Furthermore, the disclosures of all patents and patent applications cited herein are incorporated herein by reference in their entirety. Attached Figure Description

[0031] Figure 1 This is a diagram of a sensor module according to an embodiment.

[0032] Figure 2 This is a diagram of a sensor module including multiple sensing channels according to an embodiment.

[0033] Figure 3 This is a diagram of the power system of the sensor module according to an embodiment.

[0034] Figure 4 This is a diagram of the data system of the sensor module according to an embodiment.

[0035] Figure 5 This is a diagram of a data system for a sensor module according to another embodiment.

[0036] Figure 6 This is a diagram of the network of the sensor module according to an embodiment.

[0037] Figure 7 This is a schematic diagram of an ISM positioned on a stent graft within a patient according to an embodiment of the present invention, wherein the ISM is probed and outputs data.

[0038] Figures 8A-8B The diagram illustrates the development of internal leakage from the beginning of leakage (8A) to the basic formation of leakage (8B). Figure 8C and Figure 8D They are Figure 8A and Figure 8B The magnified image depicts the movement of the ISM sensor during the development of the internal leak.

[0039] Figures 9A-9H This is a schematic diagram of various types of bracket placement and contact sensors that can assist in the placement. Figure 9A The diagram illustrates the locations of narrowing and bifurcation at multiple points within the blood vessel. Figure 9B The illustration shows a support with PTCA. Figure 9C The illustration shows the support bracket unfolded (also known as "reverse T"). Figure 9D The illustration shows the support bracket unfolded (referred to as a "T-bracket"). Figure 9E The illustration shows the unfolding of a support structure called "compression". Figure 9FThe illustration shows the deployment of a support structure, referred to as a "Y" or "V". Figure 9G The illustration shows the unfolding of a support frame, also known as "Kissing". Figure 9H The illustration shows the unfolding of a support structure called a "Culotte".

[0040] Figure 10 This is a schematic diagram of an ISM with contact sensors that can be used to assist and / or aid in the placement of overlapping supports.

[0041] Figure 11 The illustration shows medical imaging of the vascular system via an ISM equipped with sensors that can detect positional movement due to vascular pathology (e.g., restenosis or thrombosis).

[0042] Figure 12 This is a representative example of implantable hip prostheses.

[0043] Figure 13 This is an illustration of an implanted hip prosthesis with several ISMs.

[0044] Figure 14 This is an isometric view of a total knee replacement.

[0045] Figure 15A yes Figure 14 Exploded view of total knee replacement. Figure 15B The tibial plate with an attached tibial extension is depicted. Figure 15C The tibial extension, separated from the tibial plate, is depicted. Figure 15D The extension of the tibia is depicted.

[0046] Figure 16 The patient underwent a total knee replacement.

[0047] Figure 17 This is a side view of a fully assembled knee joint, showing examples with different sensor positions.

[0048] Figure 18 The illustration shows an example in which an ISM with various types of sensors is deployed throughout the balloon catheter.

[0049] Figure 19 The illustration shows an example in which various types of sensors are deployed on the surface of an aesthetic (breast) implant via an ISM.

[0050] Figures 20A-20E The illustrations depict an embodiment known as vertebroplasty, in which an ISM is placed into the body of the vertebral body, followed by injection of a bone-binding agent (without using a balloon). These figures illustrate an embodiment where a hole is created in the vertebral body via a bone tunneling conduit. Figure 20A); Introducing ISM ( Figure 20B ); and the introduction of delivery devices that allow for the direct injection of bone bonding agents into collapsed bone ( ); Figure 20C Compression fractures are treated by injecting bone-setting agents into the vertebral body (e.g., Figure 20D and Figure 20E (As shown) to correct and support, in order to restore the normal height of the vertebrae.

[0051] Figure 21 The illustration shows an embodiment in which one or more ISMs are placed on and / or within a kyphoplasty balloon.

[0052] Figures 22A-22B The illustration shows various spinal fusion implants, including pedicle screws fixed to a rod. Figure 22A ) and the spinal plate held in place by screws ( Figure 22B ).

[0053] Figure 23 The illustration shows a spine (medium) cage with an ISM.

[0054] Figure 24 The illustration shows an artificial intervertebral disc with an ISM (intervertebral disc ostomy).

[0055] Figures 25A-25C The illustration shows the use and placement of external fixation devices on the bone (including the use of screws, pins, and clamps). Figure 25A ), and having placed on it ( Figure 25B ), implanted in the arm ( Figure 25C The use and placement of several external fixed devices of ISM.

[0056] Figures 26A-26B The illustration shows various braces and suspension straps. Figure 26A The illustration shows a knee brace with an ISM (Integrated Muscle Surface). Figure 26B It is a neck brace.

[0057] Figure 27 The illustration shows an embodiment in which an ISM is placed on or within several needles (Steinmann pins) that are inserted to reduce humeral fractures.

[0058] Figure 28 The illustration shows an embodiment in which an ISM is placed on and / or inside several K-wires (Kirschner wires) that are inserted to reduce radial fractures.

[0059] Figure 29A and Figure 29B The illustration shows a representative dynamic hip screw with ISM, including a cortical screw inserted into the side plate. Figure 29A), and an illustration of the device inserted into the subject ( Figure 29B ). Figure 29C The illustration shows an embodiment in which the ISM is placed on a representative mounting plate.

[0060] Figures 30A-30B The illustration shows representative intramedullary rods or nails, including intramedullary nails with ISM (intramedullary spinal cord). Figure 30A ), and the placement of intramedullary nails with ISM in the tibia ( Figure 30B ).

[0061] Figure 31A The illustration shows a representative bileaflet mechanical valve with ISM. Figure 31B The illustration shows a tilting disc mechanical valve with an ISM.

[0062] Figure 32A The illustration shows a representative porcine valve with ISM. Figure 32B The illustration shows a representative bovine valve with ISM.

[0063] Figure 33A The illustration shows an ISM on an expanded scaffold, and Figure 33B The illustration shows a representative percutaneous heart valve with ISM and a representative delivery system with ISM.

[0064] Figure 34A The illustration shows an ISM on a balloon delivery device for a balloon-expandable percutaneous heart valve, as well as an ISM on the balloon itself. Figure 34B The illustration shows an ISM on a balloon-expandable percutaneous heart valve.

[0065] Figure 35 This is a schematic diagram of an ISM in a subject within a medical device as described herein, according to an embodiment of the present invention, wherein the ISM is probed and outputs data. Detailed Implementation

[0066] In summary, this invention provides various medical devices and implants, as well as any associated medical device and / or device delivery instruments, which can be used to monitor the placement, location, anatomy, alignment, fixation, performance, healing, integrity, wear, side effects, and / or effectiveness of the medical device. However, before describing the invention, it is helpful to clarify the definitions of certain terms used below.

[0067] "Medical device" means an instrument, apparatus, construction element or component, machine, appliance or similar or related article that can be used to diagnose, prevent, treat or manage a disease or other condition. The medical devices provided herein may be implanted within a subject, delivered to a subject, or used externally, depending on the device and embodiments. In many embodiments, the medical devices provided herein are sterile and subject to regulatory requirements relating to their sale and use. Representative examples of medical devices and implants include, for example, cardiovascular devices and implants such as implantable cardioverter defibrillators, pacemakers, stents, stent grafts, bypass grafts, catheters, and heart valves; orthopedic implants (e.g., total or partial arthroplasty joints, such as hip and knee prostheses); spinal implants and hardware (spinal cages, screws, plates, pins, rods, and artificial intervertebral discs); a wide variety of medical tubes, cosmetic and / or aesthetic implants (e.g., breast implants, fillers); a wide variety of polymers, bone bonding agents, bone fillers, scaffolds, and naturally occurring materials (e.g., heart valves and grafts from other naturally occurring sources); intrauterine devices; orthopedic hardware (e.g., plaster casts, braces, tensor bandages, external fixation devices, stretchers, slings, and supports) and internal hardware (e.g., K-pins, needles, screws, plates, and intramedullary devices (e.g., rods and nails)); cochlear implants; dental implants; medical polymers; a wide variety of neural devices; and artificial intraocular lenses.

[0068] "Sensor" refers to a device that can be used to measure one or more different aspects (anatomical, physiological, metabolic, and / or functional) of body tissue and / or one or more aspects of a medical device. Representative examples of sensors suitable for use within the present invention include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, positioning 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), accelerometers, mechanical stress sensors, and temperature sensors. In some embodiments, the sensor may be a wireless sensor, or in other embodiments, the sensor may be a sensor connected to a wireless microprocessor. In further embodiments, one or more (including all) sensors may have a unique sensor identification number ("USI") and / or a unique device identification number ("UDI") that specifically identifies the sensor, through which the sensor can provide unique information about the associated medical device for the purpose of tracking the medical device manufacturer, healthcare system, and regulatory requirements.

[0069] 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 used within the scope of this invention. Representative patents and patent applications include U.S. Patent Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267 and 8,634,928, and U.S. Publications 2010 / 0285082 and 2013 / 0215979. Representative publications include Albert Foch's "Introduction to BioMEMS" published by CRC Press in 2013; Marc J. Madou's "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications" published by CRC Press in 2011; Simona Badilescu's "Bio-MEMS: Science and Engineering Perspectives" published by CRC Press in 2011; Steven S. Saliterman's "Fundamentals of BioMEMS and Medical Microdevices" presented at SPIE (International Society for Optical Engineering) in 2006; "Bio-MEMS: Technologies and Applications" edited by Wanjun Wang and Steven A. Soper published by CRC Press in 2012; Volker Kempe's "Inertial MEMS: Principles and Practice" published by Cambridge University Press in 2011; and Polla, DL et al.'s "Microdevices in..." published in the Biomedical Engineering Review in 2000. "Medicine", 02:551-576; Yun, KS et al., October 2002 J. Microelectromechanical Sys Published in 11:5,454-461, “A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations”; Yeh, R. et al., in August 2002. J. Microelectromechanical SysThe article “Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors” published in , 11:4, 330-336; and the article by Loh, NC et al. published in June 2002 J. Microelectromechanical Sys The article “Sub-10 cm3 Interferometric Accelerometer with Nano-g Resolution” published in , 11:3, 182-187; all the above publications are incorporated herein by reference in their entirety.

[0070] In various embodiments of the invention, the sensors described herein can be placed in various locations and configurations, including inside a medical device, within the body of a medical device, on the outer (or inner) surface of a medical device, between a medical device and other medical devices or implants, and / or between a medical device and any device capable of carrying or delivering the medical device (e.g., a delivery device, injection device, or surgical instrument). When the phrases “placed in a medical device” or “placed in a medical implant” are used, it should be understood that they refer to any of the above embodiments (or any combination thereof) unless the context indicates otherwise.

[0071] Sensors may be placed individually within a medical device or together with associated medical devices that may be used in a desired surgical procedure. For example, in some embodiments, the medical device and / or medical device kit includes sensors with a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per square centimeter. In other aspects, the medical device and / or medical device kit includes sensors with a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per cubic centimeter. In any of these embodiments, there may be fewer than 50, 75, 100, or 100 sensors per square centimeter or per cubic centimeter. In various embodiments, at least one or more sensors may be randomly placed or placed in one or more specific locations within the medical device, medical device, or kit as described herein.

[0072] In various embodiments, sensors may be placed in a specific location and / or randomly placed throughout the medical device and / or associated devices. Additionally, sensors may be positioned in a specific pattern (e.g., they may be arranged in a pattern X, as an ellipse or concentric ring around the orthopedic implant and / or associated device).

[0073] An "implantable sensor module" or "ISM" is a sensing device configured to be implanted or otherwise attachable to a living subject, such as a human subject, and configured to sense one or more physical quantities to generate a signal representing the sensed quantity, and to transmit the signal to a remote receiver. An ISM may have one or more sensors as described above. An ISM may be implanted directly into a subject or implanted within one or more medical devices implanted within the subject. In embodiments, the signal may contain information encoded to represent one or more of the amplitude, phase, and type of the sensed physical quantity.

[0074] In one embodiment of the invention, the ISM is a self-contained module having one or more sensors, sensor interfaces, processor interfaces, battery management, and wireless interfaces as described herein. In a preferred embodiment of the invention, the size of the ISM will be less than 5, 4, 3, 2, or 1 cubic centimeter, and more preferably, its size will be less than 5.0, 4.5, 4.0, 3.5, 3.0, 2.5, 2.0, 1.5, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, or 0.1 cubic centimeters. In various embodiments, the ISM may consist of a solid outer core or of a flexible material (e.g., a flexible / stretchable alloy, a biodegradable or non-biodegradable outer polymer surface). In related embodiments, the ISM may consist of flexible circuitry (including, for example, single-sided and double-sided flexible circuitry). In some embodiments, the ISM may be relatively square and solid, while in other embodiments it may be very thin, flexible, and long (relative to its width and / or height). This ISM can be configured for a variety of different applications (e.g., for insertion, attachment, or implantation into any medical device or implant provided herein).

[0075] Representative embodiments of medical devices and medical applications of medical devices including sensors To further understand the various aspects of the invention presented herein, the following sections are provided: A. Can be implanted with sensor modules; B. Implantable medical devices (including B1-stent grafts; B2-stents; B3-hip; B4-knee; B5-cannulas; B6-implants; B7-spinal implants; B8-orthopedic hardware; B9-polymers; B10-heart valves; and B11-manufacturing methods). C. Use of medical devices with ISM for delivering therapeutic agents; D. Methods for monitoring infections in medical devices; E. Other uses of medical devices or implants containing ISM in healthcare; F. Electricity generation from medical devices or implants; G. Medical imaging and self-diagnosis, predictive analytics, and predictive maintenance of components including medical devices or implants; H. Methods for monitoring components including medical devices or implants; and I. Collection, transmission, analysis, and distribution of data from components including medical devices or implants.

[0076] A. Implantable sensor module As described above, the present invention provides an ISM suitable for implantation or otherwise (internal or external) to a living subject (e.g., by implantation into and / or attachment to a medical device that is subsequently placed internally in a surgical procedure (hip and knee replacement, stent, heart valve, etc.) or applied externally to the body (plaster clamp, brace, stretcher, external fixation device, etc.)). Figure 1 This is a diagram of a sensor module 10 according to an embodiment of the present invention. The sensor module 10 is configured to be implantable or otherwise attachable to a living subject, such as a human subject, and is configured to sense physical quantities to generate a signal representing the sensed quantity, and transmit the signal to a remote receiver (not shown in the diagram). Figure 1 (As shown in the figure) for processing. The ISM may be implanted directly into the subject, implanted within one or more medical devices implanted within the subject, or implanted within (or attached to) a medical device fixed to the outside of the body. In embodiments, the signal may contain information encoded to represent one or more of the amplitude, phase, and type of the sensed physical quantity.

[0077] Sensor module 10 is suitable for applications requiring the sensing module to be implanted therein or attached to one or more biomasses (biomasses are physical quantities) of a subject. For example, sensor module 10 can sense one or more electrical signals generated by the subject's heart and can generate an electrocardiogram (ECG) signal representing the heart; subsequently, a receiving device can generate a visual representation of the ECG in response to the signal. Other applications include, but are not limited to, sensing one or more parameters (e.g., contact, pressure, position, movement, wear, stability, bone attachment level) related to artificial joints, brain activity, organ function, blood flow, digestion, and / or drug efficacy.

[0078] Sensor module 10 includes a power supply 12, one or more sensors 14, a sensor interface 16, a controller 18, a wireless interface 20, and an antenna 22. The power supply 12, sensors 14, channel 16, controller 18, interface 20, and antenna 22 can be arranged on one or more integrated circuit dies, which are respectively arranged in one or more integrated packages to form one or more integrated circuits (ICs); and these one or more ICs can be arranged in (within) Figure 1 (Not shown) In the subject, it may be implanted in the subject or otherwise attached to the subject. Alternatively, sensor 14 and antenna 20, or any other components described above, may not be arranged on the IC chip, but may be discrete components.

[0079] According to an embodiment, power supply 12 is configured to generate a regulated power signal (e.g., a regulated power supply voltage V). O The power supply 12 is used to power other components of the sensor module 10, and the power supply 12 includes an energy harvester 24, a battery charger 26, a power coil 28, a protector 30, and a battery container 32 for receiving the battery 34.

[0080] According to the embodiment, the adjusted power supply voltage V O For example, it can be in the approximate range of 1 to 24 volts (V). Furthermore, although not in Figure 1 As shown, however, power supply 12 can generate more than one regulated power signal.

[0081] According to an embodiment, the energy harvester 24 is configured to convert environmental stimuli into current or voltage for charging the battery 34. For example, the harvester 24 may convert one or more of the following into current or voltage for charging the battery: body heat of a subject in which the sensor module 10 is implanted or otherwise attached; kinetic energy generated by the subject's movement; pressure changes (e.g., air pressure or pressure within the subject, such as the subject's blood pressure); energy generated by electrochemical reactions within the subject's body; radio frequency (RF) energy (e.g., RF transmission from the surrounding environment); and light.

[0082] According to an embodiment, the battery charger 26 includes a power coil 28, which is configured to respond to a power unit (not in Figure 1 The near-field magnetic field generated (as shown in the diagram) produces voltage and current; such near-field charging can be similar to the technology used to power smart cards. For example, battery charger 26 and coil 28 can be used to charge battery 34, while energy harvester 24 cannot generate enough energy to charge the battery to a voltage level sufficient for proper operation of sensing module 10.

[0083] Protector 30 protects battery 34 from overcharging or other conditions that may damage the battery, and from the regulated voltage V O If the load current drawn from (or another regulated power signal generated by the power source) exceeds a predetermined safety threshold, the protector 30 also protects the power supply 12. The protector 30 can also monitor the temperature of the battery 34 and make appropriate adjustments to the safety threshold. For example, if the voltage across the battery 34 exceeds a predetermined safety threshold, the protector 30 can disable the energy harvester 24 and the battery charger 26, and can also generate some type of alarm to indicate a malfunction. Additionally, the protector 30 can draw load current from V... O The load current drawn (or from another regulated power supply signal) is limited to a safe limit, or the protector 30 can otherwise disable the power supply 12 if the load current exceeds a predetermined safe threshold; for example, if the load current carries V... O If a node is short-circuited to ground, the protector can implement such limitation or disablement.

[0084] Additionally, battery 34 can be any type of rechargeable battery, such as a lithium-ion battery, suitable for use in electronic devices that can be implanted or otherwise attached to a biological subject.

[0085] Still refer to Figure 1 One or more sensors 14 are each configured to sense a corresponding physical quantity in which the module 10 is implanted or attached to the body of a subject or otherwise affected by it, and each sensor 14 is configured to generate a corresponding sensor signal representing one or more of the amplitude, phase (if applicable), and type of the corresponding sensed quantity. Examples of such physical quantities include, but are not limited to, the relative or absolute position of the sensor module 10, the movement of the sensor module (e.g., acceleration, velocity, rotation), and quantities near the sensor module such as: electric field, voltage or current, magnetic field, temperature, pressure (e.g., blood pressure), radiation, conductivity, light intensity, spatial or temporal differences of physical quantities (e.g., temperature difference, pressure difference, or voltage difference), biomarkers (e.g., tumor markers, bacterial markers, or DNA fragments), chemical compositions of substances, and their chemical reactions or byproducts. Examples of one or more sensors 14 include, but are not limited to, sensors of the following types: Global Positioning System (GPS), accelerometer, Hall effect, electrical (e.g., current, voltage, and conductivity), magnetic, thermal, pressure, radiation, light, quantity difference, capacitance, inductance, and microelectromechanical systems (MEMS). In addition, examples of sensor signals include analog or digital voltage or current.

[0086] According to an embodiment, the sensor interface 16, which together with the sensor 14 forms the sensor channel 36, includes a power management circuit 38, an oscillator 40, an amplifier 42, a signal conditioner 44, an optional analog-to-digital converter (ADC) 46, and a control circuit 50.

[0087] The power management circuit 38 is configured to transfer V from power supply 12 O This is converted to one or more other supply voltages or supply currents for the circuitry of sensor 14 and sensor interface 16. Power manager 38 can supply power to the sensor using conductors or by induction through a coil. Sensor 14 can supply signals to sensor interface 16 using one or more conductors or by induction through a coil. The coil used to supply power to sensor 14 can be the same coil that receives signals from sensor 14. Alternatively, the coil used to supply power to sensor 14 can be separate from the coil that receives signals from sensor 14.

[0088] Oscillator 40 generates one or more clock signals for the digital and mixed-signal circuitry of sensor interface 16, and may generate analog reference signals for sensor 14 depending on the type of sensor 14. For example, sensor 14 may generate sensor signals by modifying one or more of the frequency, amplitude, and phase of such analog reference signals in response to a corresponding physical quantity. Examples of oscillators 40 include ring oscillators, operational amplifier-based oscillators, or other digital or analog oscillators.

[0089] According to an embodiment, amplifier 42 is configured to amplify the sensor signal generated by sensor 14. Although amplifier 42 is shown as having a single-ended input and a single-ended output, amplifier 42 may have one or two differential inputs and differential outputs. Examples of amplifier 42 include (e.g., an operational amplifier with a feedback configuration), and (e.g., a transconductance amplifier with an open-loop configuration). g m The sensor interface 16 may include an amplifier 42 for each sensor, or a multiplexer (mux) to select which sensor output is input to the amplifier 42. The gain of the amplifier 42 may be controlled by one or more of the signal conditioner 44 and the ADC 46.

[0090] Signal conditioner 44 is configured to condition the amplified sensor signal from amplifier 42 for reception by ADC 46 (if present) or by the controller 18 of the sensor module (if the ADC is absent). For example, conditioner 44 may be configured to adjust the amplitude and DC offset of the amplified sensor signal to be compatible with the dynamic input range of ADC 46, thereby removing noise from the amplified sensor signal or otherwise filtering the amplified sensor signal, or equalizing the amplified sensor signal. Additionally, signal conditioner 44 may be configured to add error correction coding (ECC) to the amplified sensor signal.

[0091] If present, ADC 46 is configured to convert the conditioned sensor signal from the analog domain to the digital domain; however, if sensor 14 is configured to generate a sensor signal in the digital domain, amplifier 42 and signal conditioner 44 can be digital circuitry, and ADC 46 can be omitted as described above.

[0092] Additionally, control circuitry 50 is configured to control the operation of one or more of the power manager 38, oscillator 40, amplifier 42, signal conditioner 44, and ADC 46, and may be configured to control the operation of one or more other components of sensor interface 16. For example, control circuitry 50 may include or be coupled to a memory storing configuration data or programming instructions for sensor 14 or sensor interface 16 (not in...). Figure 1 (as shown in the diagram), and the sensor 14 or interface 16 can be configured in response to this data or these instructions when the sensor module 10 is powered on. Furthermore, the control circuitry 50 can be configured to control communication between the interface 16 and the controller 18 of the sensor module.

[0093] Still refer to Figure 1 According to an embodiment, the controller 18 of the sensor module is configured to control the operation of the power supply 12, sensor channel 36, wireless interface 20, and other components of the sensor module 10. According to an embodiment, the controller 18 of the sensor module includes a microcontroller or microprocessor 52, a memory 54, and a cocontroller or coprocessor, such as a digital signal processor (DSP) 56. For clarity, the microcontroller / microprocessor 52 is referred to as a microcontroller hereinafter; it is understood that a microcontroller may be used instead of a microprocessor.

[0094] The microcontroller 52, working in conjunction with the DSP 56, is configured to process signals from the sensor channel 36 to generate data from the processed signals, and is configured to condition the signals for transmission via the wireless interface 20. For example, if the sensor 14 measures temperature, the microcontroller 52 can convert the signal from the sensor interface 16 into a temperature value in Fahrenheit or Celsius; or, if the sensor measures pressure, the microcontroller can convert the signal from the sensor interface into a pressure value in Pascals.

[0095] According to an embodiment, memory 54 may include volatile memory and non-volatile memory. For example, volatile memory may be configured to store an operating system and one or more applications executed by microcontroller 52, and non-volatile memory may be programmed to store configuration information for sensor module 10, including but not limited to: the type of sensor 14, the frequency signal generated by the oscillator, the gain of amplifier 42 and signal conditioner 44, and the voltage V generated by power supply 12. O The level.

[0096] Additionally, the wireless interface 20 is configured to receive data from the controller 18 of the sensor module, to use that data to modulate one or more carrier signals, and to transmit the modulated carrier signals via antenna 22 to a remote device (not in...). Figure 1 (as shown in the diagram) for use by a subject, for example, in which sensor module 10 is implanted or attached, or to transmit modulated carrier signals to his / her physician. For example, wireless interface 20 may be configured to operate according to one of the following specifications, but not limited to: Bluetooth®, Near Field Communication (NFC), ZigBee (IEEE 802.15), WiFi, Wireless Local Area Network (WLAN, IEEE 802.11).

[0097] Furthermore, the wireless interface 20 can be configured to receive signals from a remote device (not in use) via the antenna 22. Figure 1 The signal (shown in the diagram) is configured to be provided to the controller 18 of the power supply module. For example, such a signal may include configuration data or program instructions for the sensor module, or it may include a request from the sensor module 10 to transmit specified data to a remote device. Examples of remote devices include, but are not limited to, smartphones or tablets. Figure 4 ), computer system ( Figure 5 ) or another sensor module 10 ( Figure 6 ).

[0098] Still refer to Figure 1 According to an embodiment, the operation of the sensing module 10 during sensing mode is described.

[0099] The voltage V across battery 34 from power supply 12 BATT Generate regulated supply voltage V O (And possibly one or more other regulated power supply signals). For example, if the battery voltage V BATT >V O Then power supply 12 will give V BATT Down to V O The power supply may include a buck converter for performing such a voltage drop. Alternatively, if V BATT <V O Then power supply 12 will give V BATT Rise to V O The power supply may include a boost converter for performing such a voltage increase.

[0100] Sensor 14 is configured to sense a physical quantity and provides a sensor signal representing the sensed quantity to sensor interface 16.

[0101] The sensor interface 16 amplifies and modulates the signal via amplifier 42, signal conditioner 44, and ADC 46 (if the sensor signal is an analog signal), and converts the modulated sensor signal to the digital domain.

[0102] The controller 18 of the sensor module processes the regulated (and possibly ADC-converted) sensor signal from interface 16 and generates data representing the sensed quantity. The controller 18 may store the generated data in memory 54 for later retrieval, or it may provide the data to wireless interface 20.

[0103] Additionally, if the sensor module's controller 18 provides data to the wireless interface 20, the wireless interface uses the data from the sensor module's controller 18 to modulate one or more carrier signals, generate a transmission signal from one or more carrier signals, and transmit the transmission signal to a remote device (not in the specified location) via antenna 22. Figure 1 (As shown in the image).

[0104] Still refer to Figure 1 According to an embodiment, the operation of the sensing module 10 during the data receiving mode is described.

[0105] Power supply 12 draws voltage V from the terminals of battery 34, as described above during the sensing mode. BATT Generate regulated supply voltage V O (and possibly one or more other regulated power supply signals).

[0106] The wireless interface 20 senses the signal received by the antenna 22 and notifies the controller 18 of the sensor module.

[0107] In response to the wireless interface 20 sensing the received signal, the controller 18 of the sensor module instructs the wireless interface to demodulate the received signal, and if necessary, decode it, recover the data from the signal, and provide the data to the controller of the sensor module.

[0108] The sensor module's controller 18 analyzes the recovered data and takes appropriate action. For example, if the data is configuration data, the sensor module's controller 18 may load the data into the non-volatile portion of memory 54 and initiate a configuration cycle to configure or reconfigure one or more parts of the sensing module 10 in response to the configuration data. Alternatively, if the data is a command, the sensor module's controller 18 may execute the command. For example, if the command is a command from the sensor module 10 to a remote device (… Figure 1 If a request is made to send other specified data (not shown), the controller 18 sends the requested data via the wireless interface 20, which uses the requested data to modulate one or more carrier signals, generate a transmission signal from one or more carrier signals, and transmit the transmission signal to a remote device via the antenna 22 as described above in conjunction with the sensing mode.

[0109] Still refer to Figure 1 Alternative embodiments of the sensor module 10 are envisioned. For example, any function performed by the sensor module 10 may be performed by dedicated hardware, configurable hardware [e.g., a field-programmable gate array (FPGA)], a microprocessor or microcontroller executing program instructions, or a combination or sub-combination of dedicated hardware, configurable hardware, and a microprocessor or microcontroller executing program instructions. Furthermore, while the sensor module 10 is described as comprising components arranged in a single housing, the sensor module may comprise multiple housings / parts wirelessly linked together and / or operating independently. Additionally, while the sensor module 10 is described as implantable or otherwise attachable to a subject, it may be configured to be disposed remotely from the subject or configured to be ingested or inhaled by the subject.

[0110] Figure 2 This is a diagram of sensor module 60 according to an embodiment. Sensor module 60 is similar to... Figure 1 The sensor module 10, in addition to the sensor module 60 including multiple sensor channels 361–36 n In addition, each sensor channel may have one or more sensors 14.

[0111] Figure 3 This is a diagram of the power delivery system 70 of the sensor module according to an embodiment.

[0112] System 70 includes Figure 1The sensor module 10 includes a sensor power unit 72 with a power coil 74. The sensor power unit 72 is configured to supply power to the sensor module 10 in a manner similar to how a smart card reader can power a smart card.

[0113] During operation in the power delivery mode of sensor module 10, power coil 74 is first placed in the near field of power coil 28 of sensor module (e.g., within an approximate range of 0-4 inches).

[0114] Next, the power unit 72 is activated, which generates an alternating current (AC) voltage across the coil 74, causing an alternating current (AC) current to flow through the coil.

[0115] Because power coil 74 is in the near field near power coil 28, the coils are magnetically (i.e., inductively) coupled, such that each coil functions as a corresponding winding of a transformer. This coupling occurs even if coil 28 is implanted in the subject, such that items such as air, clothing, and biological materials (e.g., skin or other tissues and blood) separate coil 28 and 74.

[0116] Due to the inductive coupling between coils 28 and 74, the magnetic flux generated by the AC current flowing through coil 74 magnetically induces the AC current in coil 28 and the AC voltage across coil 28.

[0117] Therefore, the charger 26 of power supply 12 ( Figure 1 ) is configured to use the induced AC current through coil 28 and the induced AC voltage across coil 28 to power battery 34 ( Figure 1 Charging, or power supply 12 may include circuitry configured to directly power sensor module 10 via the sensed AC current and voltage.

[0118] After the power delivery mode is completed, the sensor power unit 72 is deactivated and the coil 74 is removed from the near field near the coil 28.

[0119] Still refer to Figure 3 Alternative embodiments of the power system 70 for the sensor module are envisioned. For example, system 70 may include... Figure 2 The sensor module 60, instead of Figure 1 Sensor module 10. Alternatively, system 70 may include more than one sensor module (e.g., one or more of one or two sensor modules 10 and 60) or more than one power unit 72. Furthermore, as described above... Figure 1 As described, when coil 74 is not in the near field near sensor module 10, or when power unit 72 is inactive, Figure 1The power source 12 can convert other energy sources (e.g., kinetic energy, temperature-induced energy, pressure-induced energy) into energy suitable for the battery 34. Figure 1 ( ) The voltage and current for charging or suitable for powering the sensor module 10.

[0120] Figure 4 This is a diagram of a sensor data system 80 according to an embodiment.

[0121] Sensor data system 80 includes Figure 1 The sensor module 10 and the remote data receiving device 82.

[0122] The remote data receiving device 82 may be or may include a smartphone or tablet computer, having circuitry sufficient to receive wireless signals transmitted by the sensor module 10 via antenna 22, demodulate the wireless signals, and recover sensor data from the wireless signals. Additionally, the device 82 may be configured to analyze or otherwise process the recovered sensor data. For example, the device 82 may be configured to display the recovered sensor data (e.g., an electrocardiogram), to provide suggestions or warnings in response to the sensor data (e.g., “low blood sugar level”), or to store the sensor data for later processing by the device 82 or another device, or for follow-up examination by a medical professional.

[0123] Still refer to Figure 4 According to an embodiment, the operation of the sensor data system 80 is described.

[0124] First, device 82 notifies sensor module 10 that the device wants to receive sensor data, or sensor module notifies device that sensor module wants to send sensor data to device.

[0125] Next, sensor module 10 and device 82 use, for example, handshake technology to establish communication.

[0126] Subsequently, the sensor module 10 transmits signals including sensor data according to communication protocols such as Bluetooth® or NFC.

[0127] Next, device 82 receives the transmitted signals and recovers the data from them.

[0128] Subsequently, sensor module 10 notifies device 82 when all data has been transmitted.

[0129] Next, device 82 notifies sensor module 10 that it has received all the data, or that it (e.g., due to a communication error) needs sensor module to resend some or all of the data.

[0130] Subsequently, if sensor module 10 has more data to send, it notifies device 82, or device requests additional data from sensor module 82. If sensor module 10 sends additional data, it follows the same procedure described above.

[0131] After the sensor module 10 has completed transmitting all available or requested data, the sensor module 10 notifies the device 82, and the device 82 confirms the notification to the sensor module.

[0132] Next, sensor module 10 and device 82 stop communicating with each other.

[0133] Subsequently, device 82 may display a representation of the recovered data, provide suggestions or warnings based on the recovered data, transmit the data to another device such as a computer system in a doctor's office via, for example, a telephone system, or store the data for later access.

[0134] Still refer to Figure 4 Alternative embodiments of the sensor data system 80 are envisioned. For example, system 80 may include... Figure 2 The sensor module 60, instead of Figure 1 The sensor module 10. Alternatively, the system 80 may include more than one sensor module (e.g., one or more of one or two sensor modules 10 and 60) or more than one device 82. Furthermore, the data sent by the sensor module 10 to the remote device may be status data of the sensor module in addition to sensor data, or in lieu of it. Additionally, the remote device 82 may send data to the sensor module 10, such as configuration data or command data.

[0135] Figure 5 This is a diagram of a sensor data system 90 according to an embodiment.

[0136] Sensor data system 90 can be similar to Figure 4 The sensor data system 80, except for system 90, includes a computer system 92 with a communication interface (e.g., a Bluetooth® interface) 94, instead of device 82. Computer system 92 and interface 94 can be configured to operate together or separately. Figure 4 Device 82 is described as performing an operation.

[0137] Still refer to Figure 5 Alternative embodiments of the sensor data system 90 are envisioned. For example, system 90 may include... Figure 2 The sensor module 60, instead of Figure 1The sensor module 10. Alternatively, the system 90 may include more than one sensor module (e.g., one or more of one or two sensor modules 10 and 60) or more than one computer system 92. Furthermore, the data sent from the sensor module 10 to the computer system 92 may be status data of the sensor module other than or in lieu of sensor data. Additionally, the computer system 92 may send data to the sensor module 10, such as configuration data or command data.

[0138] Figure 6 This is a diagram of the sensor module network 100 according to an embodiment.

[0139] Network 100 includes multiple sensor modules 10 ( Figure 1 These sensor modules 10 are configured to communicate with each other using, for example, ZigBee or another multi-node wireless network protocol. For example, the sensor modules 10 may be implanted or otherwise attached to the same subject, or implanted or otherwise attached to two or more different subjects.

[0140] Still refer to Figure 6 According to an embodiment, the operation of the sensor module network 100 is described.

[0141] First, when the initiating module in module 10 of network 100 is ready to communicate with the responding module in the module, the initiating module first determines whether the communication channel is open, that is, no other sensor module is currently using the channel for inter-module communication.

[0142] If the initiating module 10 determines that the communication channel is open, it notifies the responding sensor module that it wants to receive sensor data or other data from the responding sensor module, or the initiating sensor module notifies the responding sensor module that it wants to send sensor data or other data to the responding sensor module.

[0143] Next, the initiating sensor module 10 and the responding sensor module 10 use, for example, handshake technology to establish communication and also notify the other sensor modules that the communication channel is in use.

[0144] Subsequently, the initiating sensor module 10 transmits a signal including sensor data; or, if the initiating sensor module requests data, the responding sensor module transmits a signal to the initiating sensor module.

[0145] Next, one of the initiating sensor module 10 and the responding sensor module 10 that is to receive data receives the transmitted signal and recovers the data from it.

[0146] Subsequently, the sensor modules transmitting data in the initiating sensor module 10 and the responding sensor module 10 notify the receiving sensor modules in the initiating sensor module and the responding sensor module when all data has been transmitted.

[0147] Next, the receiving sensor module in the initiating sensor module 10 and the receiving sensor module in the responding sensor module 10 notifies the transmitting sensor module in the initiating sensor module and the transmitting sensor module in the responding sensor module that it has received all the data, or whether (e.g., due to a communication error) the transmitting sensor module in the initiating sensor module and the transmitting sensor module in the responding sensor module needs to resend some or all of the data.

[0148] Subsequently, if the transmitting sensor module in both the initiating and responding sensor modules 10 has more data to send, the transmitting sensor module notifies the receiving sensor in either the initiating or responding sensor module, or the receiving sensor module requests additional data from the transmitting sensor module in either the initiating or responding sensor module. If the transmitting sensor module in either the initiating or responding sensor module sends additional data, the same procedure is followed.

[0149] After the transmitting sensor module in the initiating sensor module 10 and the responding sensor module 10 has completed transmitting all available or requested data, the transmitting sensor module notifies the receiving sensor module in the initiating sensor module and the responding sensor module, and the receiving sensor module confirms the notification to the transmitting sensor module in the initiating sensor module and the responding sensor module.

[0150] Next, the initiating sensor module 10 and the responding sensor module 10 stop communicating with each other.

[0151] Subsequently, the receiving sensor module in the initiating sensor module 10 and the responding sensor module 10 can use the recovered data for any suitable purpose.

[0152] Still refer to Figure 6 Alternative embodiments of the sensor module network 100 are envisioned. For example, network 100 may include... Figure 2 The sensor module 60, instead of Figure 1 The sensor module 10. Alternatively, the network 100 may include one or more of the sensor modules 10 and 60.

[0153] Still refer to Figure 6Alternative embodiments of the sensor module network 100 are envisioned. For example, network 100 may employ a master-slave protocol, where only one sensor module acts as the master, simultaneously or one at a time sending and receiving data to and from multiple sensors, and receiving data one at a time from the sensor modules; in an alternative, the master sensor module may not contain any sensors. The master sensor module receives data from transceivers outside the body and transmits that data.

[0154] B. Temporary and permanent implantable medical devices and their use B.1. Scaffold graft. 401 In one embodiment of the invention, a stent graft having one or more ISMs as described herein is provided. In short, as used herein, "stent graft" refers to a device comprising a graft or covering (composed of textiles, polymers, or other suitable materials such as biological tissue) and an intravascular scaffold or stent (including expandable and balloon-inflatable stent structures) that maintains the flow of fluid (e.g., blood) from one part of a blood vessel to another, and that the intravascular scaffold or stent maintains an open access to the body and / or supports the graft or covering. Intravascular stent grafts can be used to treat a variety of vascular conditions, including abdominal and thoracic aortic aneurysms (referred to as "EVAR"—intrinsic aortic aneurysm repair), atherosclerosis, peripheral vascular disease, or other vascular conditions. Intravascular stent grafts are also used in dialysis grafts and dialysis fistulas to treat obstructions or aneurysms occurring at vascular access sites in hemodialysis patients. Nonvascular stent grafts can be used in a variety of other body access sites, such as, to name a few, the esophagus, colon, bile duct, urinary tract, and ureter. In some embodiments, the stent graft has at least two openings (while in other embodiments, three or more openings), an outer (adluminal) surface, and an inner (luminal) surface. In some embodiments, the stent graft is an "articulated" or "segmented" stent graft; these multi-part stent grafts are inserted into their final configuration as individual segments subsequently assembled into the body (artery or other body access). In other embodiments, the stent graft is fenestrated (e.g., FEVAR-fenestrated intravascular aortic aneurysm repair), wherein a hole is formed in the graft body material that maintains patency of vital vessels (or collateral branches). In some embodiments, the stent graft has a unique device identification ("UDI") number.

[0155] In embodiments of the invention, one or more ISMs and / or sensors may be placed on the stent graft (intracavitary or proximal), and / or placed within the stent graft (e.g., placed within the metal strut of the stent graft or embroidered into the fabric of the stent graft). Representative examples of sensors placed on stent grafts are provided in PCT Publication No. WO2014 / 100795, which is hereby incorporated herein by reference in its entirety.

[0156] B.1.A. Scaffold grafts and internal leakage As mentioned above, stent grafts are commonly used in a wide variety of medical procedures to open and / or maintain the lumen of bodily passages (e.g., arteries, gastrointestinal tract, urethra). However, they are most commonly used in vascular surgical procedures, such as in the treatment of aortic aneurysm disease. An aortic aneurysm (AA) is a dilation of the aorta, usually caused by an underlying disease (often atherosclerosis) that weakens the vessel wall. As the aneurysm grows (dilates) over time, the risk of it ruptures or bursts increases rapidly; if left untreated, it can lead to massive bleeding and death. A stent graft is inserted into the aneurysm to not only simply keep the diseased vessel open but also to bridge the dilated segment of the vessel from a healthy vessel to a healthy vessel.

[0157] In short, a stent graft is inserted onto a guidewire from the femoral or iliac artery and deployed within the aneurysm, resulting in the maintenance of blood flow from a portion of the aorta or iliac artery of an acceptable (normal) diameter above the aneurysm to a portion of the aorta or iliac artery of an acceptable (normal) diameter below the aneurysm. Thus, the aneurysm sac is excluded from circulation. The blood within the excluded aneurysm sac forms a thrombus and therefore has no flow within it, potentially reducing pressure and thus decreasing its tendency to rupture.

[0158] However, currently available stent grafts have many limitations, such as endoleak, migration, detachment, wear and durability issues, rupture, stenosis, kinking, and misalignment. For example, current stent grafts are prone to persistent blood leakage around the stent graft area and into the aneurysm sac (a condition known as "endoleak"). Consequently, the pressure within the aneurysm sac does not decrease, remaining at or near the arterial pressure, and the aneurysm remains at risk of rupture. Endoleak is the most common and clinically dangerous complication of stent graft placement, and early detection and treatment of endoleaks remain a significant medical challenge. In some embodiments, the stent graft of the present invention has a pressure detection sensor capable of detecting elevated pressure within the aneurysm sac and alerting the patient and / or attending physician of a potential endoleak. A pressure sensor contained within an ISM (intraluminal splint) can detect an increase in pressure near the lumen (the outer surface of the graft in contact with the vessel wall). The ISM itself is either contained within the stent graft (e.g., within a metal strut of the stent graft or embroidered into the fabric of the stent graft) or attached to the stent graft; this indicates that pressure within the aneurysm sac is rising and the aneurysm is no longer being excluded from circulation. Since most endoleaks are asymptomatic (rupture is often the first symptom), a gradual or rapid increase in the pressure near the stent graft lumen (or aneurysm wall pressure) is an important early indicator, warranting medical attention and investigation into its underlying cause. Currently, there is no such continuous monitoring and early detection system for identifying endoleaks, and embodiments of the present invention will greatly facilitate the identification and early treatment of this potentially fatal complication of stent graft treatment.

[0159] There are five common types of perigraft leakage (endoleakage), and corrective measures can be varied depending on the underlying cause. In some embodiments, the stent graft of the present invention includes an ISM comprising one or more sensors of various types, including but not limited to fluid pressure sensors, contact sensors, positioning sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, (e.g., for blood and / or other fluids) chemical sensors, (e.g., for blood and / or other fluids) metabolic sensors, accelerometers, mechanical stress sensors, temperature sensors, etc., which can provide information that helps physicians determine what type of endoleak may be present.

[0160] Type I endoleaks occur when there is direct leakage of blood around the stent graft (proximal or distal) into the aneurysm sac. This type of endoleak can persist from insertion due to poor sealing between the stent graft and the vessel wall, or may subsequently expand due to loss of the seal. Additionally, this problem can occur due to changes in the position or orientation of the stent graft relative to the aneurysm as the aneurysm grows, shrinks, elongates, or shortens over time after treatment. Type I endoleaks also typically occur if the stent graft "migrates downstream" from its initial placement point due to distal displacement via blood flow and arterial pulsation. A representative stent graft may have an ISM (Integrated Stent Module) with contact sensors and / or positioning sensors implanted / fixed to the proximal end of the stent graft to detect loss of contact with the vessel wall that can indicate potential Type I endoleaks. An IMR (Integrated Stent Module) may also be located distally to the stent graft (and within the stent graft body) to aid in the identification of Type I endoleaks. Stent grafts equipped with an ISM (Integrated Stent Detector) featuring both pressure and contact sensing devices can indicate the presence of suspected endoleaks by detecting elevated proximal lumen pressure. Furthermore, loss of contact with the vessel wall at the proximal and / or distal ends of the graft (as detected by contact sensors) will suggest the presence of a type I endoleak, while loss of contact between the stent graft body and the vessel wall will indicate the location, size, and extent of an endoleak present within the aneurysm sac. Finally, an ISM with positioning sensors and / or accelerometers concentrated at the proximal and / or distal ends of the stent graft (and within the stent graft body) can detect movement (migration) of the stent graft from its original placement site (a common cause of type I endoleaks) and also (by detecting deformation of the stent graft wall) assist in determining the size and location of the endoleak.

[0161] As described above, in some embodiments of the invention, specific sensors can be identified by their USI (Underlying Intraceness) and their location within the stent graft. Therefore, a more comprehensive picture or analysis of the overall function of the stent graft (and the patient's response to the stent graft) can be determined collectively based on an understanding of the location and activity of a set of sensors. For example, when the set of sensors is analyzed as a group, it can be used to determine the specific type, degree, and location of the endoleak. Additionally, the set of sensors can be used to assess a variety of other conditions, including, for example, kinking or deformation of the stent graft and stenosis of the stent graft.

[0162] Type II perigraft leakage (type II endoleak) can occur due to lateral artery extensions from the treated vessel segment (typically the lumbar artery, testicular artery, and / or inferior mesenteric artery). Once the aneurysm is removed by the stent graft, flow can reverse within these vessels and continue to fill the aneurysm sac surrounding the stent graft. Representative stent grafts may have an ISM equipped with contact sensors and / or positioning sensors (ideally, the ISM will be incorporated into the proximal and distal ends of the stent graft, and potentially within the body of the stent graft) to aid in the identification of type II endoleaks. Stent grafts equipped with an ISM with pressure sensing and contact sensing devices can indicate the presence of a suspected endoleak by detecting elevated proximal luminal pressure; furthermore, persistent contact with the vessel wall at the proximal and / or distal ends of the graft (as detected by contact sensors) will suggest that the endoleak may be type II, while loss of contact between the stent graft body and the vessel wall will suggest the location, size, and extent of the endoleak present in the aneurysm sac. Finally, ISMs with localization sensors and / or accelerometers focused on the proximal and distal ends of the stent graft will confirm that the stent graft has not migrated from its original placement site, while those ISMs within the body of the stent graft will (by detecting deformation of the stent graft wall) assist in determining the size and anatomical location of the endoleak, which can indicate the vessel as the cause of type II endoleak.

[0163] Type III endoleaks can occur due to device dislodgement (in the case of modular or segmented devices). Due to the complex vascular anatomy, the diversity of aneurysm shapes, and the need to tailor stent grafts to specific patients, many stent grafts consist of several segments inserted separately and constructed into their final configuration within the aorta. Dislodgement at the articulation point can occur due to improper placement or deployment, or due to changes in the shape of the aneurysm over time (growing, shrinking, elongating, or shortening) after treatment. A representative segmented stent graft may have an ISM (Integrated Semiconductor Sensor), which has contact sensors and / or positioning sensors implanted / secured to the stent graft at the articulation point to aid in assessing the integrity of the seal between stent graft segments. During stent graft placement, an ISM with complementary (paired / matched) contact sensors on the corresponding articulated segments can confirm that precise and accurate connections have been achieved during device construction. If a Type III endoleak occurs, gaps / discontinuities between the contact sensors on the complementary segments can be detected to determine both the location and extent of the present endoleak.

[0164] Type IV endoleaks occur due to the development of pores within the graft material, through which blood can leak into the aneurysm sac. The continuous pulsation of the blood vessels causes friction between the graft material and the metal stent tip (tynes), ultimately leading to fabric abrasion and graft failure. A representative stent graft has an ISM (Integrated Sensor Mechanism) incorporating fluid pressure sensors, contact sensors, positioning 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), accelerometers, mechanical stress sensors, temperature sensors, etc., which are integrated within the body of the stent graft (e.g., integrated within the metal struts of the stent graft or embroidered into the fabric of the stent graft) to aid in the identification of Type IV endoleaks. If defects arise in the graft material, the embedded ISM sensors will assist in determining the size and location of the endoleak by detecting deformation and defects in the stent graft wall. In extreme cases, stent graft wall defects can lead to stent graft rupture; conditions that can be detected early, as is the case in embodiments of the present invention.

[0165] The final type of endoleak (V-type endoleak) is leakage of unknown origin. A representative stent graft in an ISM equipped with fluid pressure sensors, contact sensors, positioning 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), accelerometers, mechanical stress sensors, temperature sensors, etc., can indicate the presence of a suspected endoleak by detecting elevated proximal lumen pressure. Furthermore, changes in the stent graft can be detected by loss of contact with the vessel wall detected by contact sensors, changes in positioning sensors, and / or movement detected by accelerometers, and (by detecting deformation of the stent graft wall) can help determine the size and location of the endoleak.

[0166] The integration of data from fluid pressure sensors, contact sensors, positioning 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), accelerometers, mechanical stress sensors, temperature sensors, etc., can produce a computer-generated reconstruction of the scaffold graft wall, which can serve a similar function to medical “imaging” of the device (see example...). Figures 9A-9H and Figure 10 In some embodiments, the stent grafts of the present invention, which include an ISM, can provide sensing information to serve a variety of important clinical functions.

[0167] For example, this information is useful to clinicians during the initial placement of stent grafts to determine whether the stent graft is anatomically correct, whether there is leakage around the graft, whether the stent graft segments are properly assembled, to detect graft kinking or deformation, and to determine whether there is uniform blood flow through the device (to name just a few important functions). Stent graft misalignment during placement or due to subsequent movement / migration is a common complication of stent graft treatment. The ISM-containing stent graft of this embodiment can be used to confirm proper initial placement, assembly, and deployment, as well as any subsequent dislodgement or migration. Dislodgement of the graft as a whole (from the artery) or detachment of individual graft segments from each other is another problematic complication of stent graft insertion and continued treatment. The stent graft of the present invention has the ability to detect movement / detachment of the entire stent graft as well as movement and / or detachment of individual segments, providing valuable diagnostic information for clinicians and patients. Kinking of the stent graft during deployment and / or due to subsequent movement after placement is also a significant clinical problem when it occurs. The scaffold graft of the present invention has an ISM having positioning sensors and accelerometers distributed throughout the scaffold graft, which are capable of detecting deformation and kinking of the scaffold graft.

[0168] In some cases, the lumen of a stent graft may narrow and restrict blood flow through the graft due to external compression (such as endoleak), stenosis (the growth of thickened vascular tissue known as neointimal hyperplasia on the inner surface of the stent graft), or the formation of a blot clot. The stent grafts of the present invention have various ISMs containing sensors capable of detecting and differentiating the type of stenosis. Blood flow sensors, fluid pressure sensors, and blood volume sensors located on the inner surface of the lumen can detect the presence and location of the stenosis due to the increased blood flow velocity and increased blood (and pulse) pressure at the site of the stenosis (relative to the normal graft segment). Stenosis caused by external compression (such as the presence of endoleak discussed above) will be sensed by the stenosis itself (increased blood flow velocity and increased pressure). Stenosis caused by neointimal hyperplasia or intraluminal clot formation will be detected as a “dead spot” on the luminal surface and / or changing readings. ISMs with blood flow sensors, (e.g., for blood and / or other fluids) blood metabolism and / or chemical sensors will become obscured by vascular tissue or clots and will stop displaying; while ISM proximal pressure sensors and accelerometers will not show changes in proximal pressure or stent graft wall deformation (as would occur with endoleak). ISMs with metabolic and chemical sensors can determine the difference between stenosis (normal pH and physiological readings) and clots (decreased pH and changing physiological readings).

[0169] As mentioned, stent grafts are typically placed in arteries (usually the aorta) at anatomical locations where important collateral branches originate. The renal arteries are most important, but the lumbar, testicular, inferior mesenteric, and internal iliac arteries can be affected by aortic aneurysms. To maintain the patency of these arteries (and prevent them from becoming blocked due to stent graft placement), stent grafts with perforations (or fenestrations) have been developed, allowing blood flow through the graft and into arteries branching from the aorta. FEVAR (fenestrated intravascular aortic aneurysm repair) is a form of stent graft design and treatment that maintains the patency of important vessels originating from the aorta. The stent graft of the present invention has an ISM at the fenestration site equipped with a blood flow sensor, a fluid pressure sensor, a pulse pressure sensor, a blood volume sensor, and / or blood chemistry and metabolism sensors to monitor blood flow through the collateral branches. The stent graft of the present invention may also have an ISM at the fenestration site with a positioning sensor, a contact sensor, and / or an accelerometer to monitor the patency of the collateral branches (stenosis and / or kinking, migration, and blockage of arterial branches due to the stent graft itself).

[0170] In addition, patients requiring stent grafts often have extensive cardiovascular disease that leads to impaired cardiac and circulatory function. For example, patients receiving stent grafts have an increased risk of myocardial infarction (heart attack), congestive heart failure, kidney failure, and arrhythmias. The aorta is the largest blood vessel originating from the heart; therefore, monitoring certain hemodynamic and metabolic parameters within the aorta can provide clinicians with very important information about a patient's cardiac, renal, and circulatory function. The stent graft of the present invention comprises an ISM having fluid pressure sensors, contact sensors, positioning 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), accelerometers, mechanical stress sensors, temperature sensors, etc., suitable for these purposes. Representative stent grafts of the present invention may have an ISM on and / or inside the stent graft, the ISM having pressure sensors, pulse pressure sensors, pulse contour sensors, blood volume sensors, and blood flow sensors. These sensors can be used by those skilled in the art to calculate and monitor important physiological parameters such as cardiac output (CO), stroke volume (SV), ejection fraction (EV), systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), total peripheral resistance (TPV), and pulse pressure (PP). For example, FloTrac / Vigileo (Edwards Life Sciences, Irvine, California) uses pulse contour analysis to calculate stroke volume (SV) and systemic vascular resistance (SVR); the Pressure Recording Analysis Method (PRAM) is used by Most Care (Vytech, Padua, Italy) to estimate cardiac output (CO) based on analysis of arterial pressure waveforms. Changes in cardiac output (CO), stroke volume (SV), ejection fraction (EF), and cardiac index (CI) are important in detecting complications such as myocardial ischemia and infarction; they can also assist clinicians in implementing and adjusting cardiac medications and dosages. ISMs with pulse pressure sensors, pulse contour sensors, and heart rate sensors, incorporated on and within the stent grafts of this invention, can assist in the detection and monitoring of arrhythmias and heart rate abnormalities; they can also be used to monitor patient responses to cardiac medications that affect heart rate and rhythm. Readings of systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), and total peripheral resistance (TPV) can be used by clinicians to monitor the dosage and effects of antihypertensive and vasopressor (blood pressure stimulant) medications.

[0171] As mentioned above, patients requiring stent grafts often have cardiovascular complications such as kidney injury or kidney failure. The renal arteries originate from the aorta and are typically located very close to the typical stent graft placement site; therefore, monitoring certain hemodynamic and metabolic parameters within the aorta provides physicians and patients with crucial, real-time information about ongoing kidney function. The stent grafts of this invention may comprise an ISM with circulatory sensors (as described herein) suitable for monitoring kidney function, as well as chemical sensors (e.g., for blood and / or other fluids) and metabolic sensors (e.g., for blood and / or other fluids). Examples of blood chemical and metabolic sensors used in this embodiment include, but are not limited to, blood urea nitrogen (BUN), creatinine (Cr), and electrolytes (calcium, potassium, phosphate, sodium, etc.). Furthermore, the combination of metabolic data with hemodynamic data and urinalysis allows clinicians to calculate the glomerular filtration rate (GFR), a very useful measure of kidney function. This information will be particularly useful in the management of dialysis patients to monitor the duration, effectiveness, and frequency of dialysis treatment.

[0172] Finally, due to the numerous complications described above, there remains long-term uncertainty regarding the efficacy of stent grafting as a treatment for aortic aneurysms. While standard open surgical aneurysm repair is more invasive and traumatic, it is extremely durable and effective. Uncertainties regarding endovascular stent grafts include whether they will reduce aneurysm rupture rates, perigraft leakage (endoleakage) rates, device migration, the ability to effectively remove aneurysms over the long term, and device rupture or dislodgement. The ISM-integrated stent graft of the present invention represents a significant advancement in stent grafting therapy by its ability to detect and monitor many (if not all) of the aforementioned complications.

[0173] A representative example of a sensor placed on a scaffold graft is provided in PCT Publication No. WO2014 / 100795, which is hereby incorporated in its entirety by reference.

[0174] B.1.B. Representative Examples of Scaffold Grafts and Endoleaks Representative examples of scaffold grafts with ISM are in Figure 7 and Figures 8A-8D As shown in the image. In short, Figure 7The illustration depicts the types of abdominal aortic aneurysms that can occur in patients. A stent graft is positioned within the aneurysm to form a stent graft that is in physical contact with the vessel wall proximally and distally (and "seals" or removes the aneurysm from circulation). While such stent grafts are beneficial in reducing pressure within the aneurysm sac and significantly improving patient health, difficulties can sometimes arise where blood avoids or passes through the stent graft, leading to various types of endoleaks. To monitor patient health, it is desirable to identify any of the five types of endoleaks (discussed above) that can occur in the stent graft. Additionally, it is desirable to monitor cardiac output, blood flow, blood volume, and various properties of the blood within the stent graft.

[0175] Figure 7 The illustration also shows one or more ISMs that can be positioned within, on, or inside the wall of the stent graft (e.g., positioned within the metal strut of the stent graft or embroidered into the fabric of the stent graft) to sense various conditions of the stent graft relative to the blood vessel, circulation, and the state of the aneurysm. While the ISMs (or multiple ISMs) can be located anywhere practically feasible (e.g., multiple ISMs can be located in the band, proximal, distal, and / or circumferentially throughout the stent), particularly important locations include the proximal (and to a lesser extent distal) end of the stent graft and the segment of the graft adjacent to the aneurysm sac. For example, one or more ISMs containing one or more pressure sensors can be located at the proximal and distal ends of the stent graft and within the aneurysm sac to sense fluid pressure at various locations along the outer wall of the stent graft and within the aneurysm sac. Furthermore, the ISMs can include one or more contact sensors and can be located at the distal end of the stent graft, the proximal end of the stent graft, and at various locations along the stent graft in contact with the aneurysm wall to determine whether the stent is in physical contact with the vessel wall. ISM contact sensors can be of the physical pressure sensor type, while ISM pressure sensors are fluid pressure sensors. Additionally, one or more location markers can be placed in the ISM and positioned to determine if the ISM (and therefore the stent graft) has moved relative to the vessel wall, as stent graft movement is one of the conditions that can cause endoleak and failure.

[0176] In various embodiments, the ISM may be powered by one or more batteries located on the outside of the stent graft (e.g., positioned such that it will be located within the site of the aneurysm). Similarly, other components of the ISM may also be located on the stent graft such that, once deployed, they will be located within the site of the aneurysm.

[0177] An intraluminal blood flow sensor (ISM) with sensors in contact with the inner (luminal) wall of the stent graft can monitor both the integrity of the stent graft and the properties of the blood flowing through it. Therefore, the ISM sensors on the luminal surface of the stent graft may include a pulse analyzer to determine the patient's pulse characteristics. It may also include multiple blood pressure sensors to sense the patient's blood pressure. It may include both a blood flow detector and a blood volume detector to calculate the patient's cardiac output. Furthermore, the stent graft provides an excellent location to determine various blood properties (such as pH, glucose level, oxygen content, cholesterol level) and other properties as arterial blood flows through it. Therefore, various intraluminal sensors in the ISM can be used to sense both the integrity of the stent graft and the properties of the blood flowing through it.

[0178] The ISM sensors used may also include accelerometers and motion sensors to detect stent graft movement due to heartbeat, migration, or other physical changes. Changes in the position of the accelerometer and / or motion sensor over time can be used as a measurement of changes in the position of the stent graft and / or vessel wall over time. Such positional changes can serve as alternative markers of the vessel and stent graft anatomy—that is, they can form an “image” of the stent graft and / or vessel wall to provide information about the size, shape, and location of endoleaks, stent graft kinking, segmental stent graft dislodgement, stent graft stenosis, clot formation, and / or stent graft movement / migration.

[0179] For example, such as Figures 8A-8D The image shown is a magnified view of the proximal end of the stent graft, illustrating the location of the ISM containing various sensors that perform sensing functions for both stent graft integrity and the patient's blood properties. More specifically, Figure 8A This illustrates the development of the endoleak, which eventually becomes more complete. Figure 8B ). Such as an enlarged image ( Figure 8C and Figure 8D As shown, the ISM located in the stent graft wall adjacent to the aneurysm sac will have sensors that will move from their typical (original) designated location to different locations due to endoleak. The movement, rate of movement, pressure, and other measurements (depending on the type of sensor included in the ISM) can be queried at a single point in time as well as over time to track the progression of the endoleak (and to attempt to correct for treatment success / failure). Furthermore, the three-dimensional spatial deformation of the stent graft (and, if time is also taken into account, four-dimensional deformation) can be determined based on the movement, pressure, and other measurements of the ISM sensors and used to provide sizing and anatomical location of the endoleak.

[0180] The collection of data from ISM sensors can also be used to ensure proper placement of the stent graft (e.g., no leakage during placement), complete articulation of the stent graft, full deployment (expansion) of the stent graft, and proper positioning of the stent graft (e.g., aneurysm and arterial branches relative to the aorta).

[0181] B.2 bracket In one embodiment of the invention, a stent having one or more ISMs as described herein is provided. In short, a “stent” refers to a medical device that can be used to maintain open body structures and / or channels and can be used to treat and / or prevent a wide variety of diseases and / or conditions caused by luminal narrowing or obstruction; whether due to damage to or external compression of the vessel wall (benign or malignant tumors, abscesses, cysts), disease processes occurring within the vessel wall (e.g., cancer, atherosclerosis, inflammation, scarring, or stenosis), disease processes occurring on the surface of the vessel wall (or within the lumen) (thrombosis, atherosclerosis, restenosis, tumor growth, inflammation and scarring, gallstones and urinary stones, mucus impaction, etc.), and / or surgical or other medical interventions causing vascular damage.

[0182] Stents can be used in a wide variety of tubular passages to maintain the normal movement of substances passing through them (blood, digestive contents, digestive enzymes and bile, air, urine, reproductive substances). These tubular passages include, for example, vascular structures (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, iliac arteries, femoral arteries, popliteal arteries, tibial arteries, mesenteric arteries, pulmonary arteries and other branches of these arteries; large veins, such as the superior vena cava and inferior vena cava and jugular veins, upper and lower limbs), gastrointestinal structures (e.g., esophagus, duodenum, small intestine, colon, bile ducts and pancreatic ducts), pulmonary structures (e.g., for maintaining the opening of the trachea, bronchi or bronchioles), urinary system structures (collecting system, ureters, urethra), female and male reproductive system structures (e.g., for maintaining the patency of the fallopian tubes, prostatic urethra), sinus structures in the head and skull (maxillary sinus, frontal sinus, lacrimal duct), and inner ear structures (osseous ventriculostomy tube).

[0183] Typically, stents are composed of metallic or polymeric components and have a monolithic structure or multiple components (e.g., a bifurcated stent system). Stents can be non-degradable, partially degradable, or fully degradable. Additionally, stents can be coated with one or more different compositions, including both polymers and drugs (including biologics and stem cells). Representative examples of stents include those disclosed in U.S. Patent Nos. 6,852,153, 7,942,923, 7,753,947, 7,879,082, and 8,287,588, and in various publications (see, for example, “Open Stent Design: Design and analysis of self-expanding cardiovascular stents” by Craig S. Bonsignore, November 2012, on the CreateSpace Independent Publishing Platform, and “Coronary Stents” by Sigwart and Frank (eds.), 2012, on Springer).

[0184] In a preferred embodiment, the bracket of the present invention has a unique device identification (“UDI”) number, and each sensor of the ISM located within the bracket has a unique sensor identification (“USI”).

[0185] Additionally, in various embodiments of the invention, one or more ISMs and / or sensors may be placed on a support (intracavitary or proximal to the cavity) and / or placed within the support (e.g., placed within a metal strut of the support or embroidered into the fabric of the "covered" support). Representative examples of sensors placed on a support are provided in PCT application number PCT / US2014 / 028323, which is hereby incorporated herein by reference in its entirety.

[0186] B.2.A. Support and its use As described above, stents are used to open and maintain the lumen of diseased bodily channels (e.g., arteries, gastrointestinal tract, urethra), but their greatest utility is found in the management of vascular diseases. In short, a stent is inserted into a lumen to physically maintain an open structure and / or channel that has been blocked or partially blocked (typically tubular organ structures such as blood vessels, gastrointestinal tract, urethra, sinuses of the skull, respiratory tract, or male and female reproductive tracts), thereby reducing or eliminating the movement of substances (typically fluids, solids, or air) through them. Stents are typically placed percutaneously (e.g., vascular stents are usually inserted into the vascular system via the femoral artery in the groin or the radial artery in the arm, and subsequently manipulated by blood flow under radiographic guidance until they reach the diseased vessel) or by insertion via a natural orifice (e.g., mouth, nose, anus, urethra) and placement under direct vision (endoscopy) into the affected organ (lungs, GI tract, urethra). Most commonly, the stent is delivered in compressed form to the deployment site and subsequently (usually by inflating a balloon with the stent or by using a "self-expanding" stent) expands to the appropriate position to open the organ lumen back to its original size and shape. Symptoms of obstruction or blockage (e.g., chest pain, claudication, neurological deficits, dysphagia, bowel obstruction, jaundice, dyspnea, infertility, urinary tract obstruction, sinus pain) depend on the affected organ, and the restoration of normal anatomy and lumen function is the goal of stent therapy. Stent failure can be caused by a variety of reasons, including improper placement, improper sizing, incomplete opening or deployment of the stent, inward growth of tissue into the stent lumen (restenosis, tumor cell growth, inflammation), intraluminal obstruction (clots, gallstones, kidney stones), stent fracture, stent kinking, and stent migration. Stents incorporating ISM sensors that can assist physicians in the proper placement and deployment of the stent, and stents capable of continuous monitoring to detect evidence of partial and / or complete obstruction, will offer significant benefits compared to existing devices.

[0187] In various embodiments, the ISM containing the sensor may be positioned on / within the stent, wherein the sensor is exposed to blood flowing through the stent (on the stent's luminal surface). A wide variety of sensors may be placed in the ISM on the luminal wall of the stent, inside the stent, and / or on the outer (proximal) wall of the stent (e.g., a portion of the stent strut itself may be comprised of an ISM, such that the sensor is in contact with all aspects of the stent (luminal, internal, proximal). Representative sensors that may be used in one or more ISMs on / within the stent include fluid pressure sensors, contact sensors, positioning sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood (and tissue) metabolism sensors, accelerometers, mechanical stress sensors, vibration sensors, and temperature sensors.

[0188] In various embodiments, the (coronary, peripheral, and cerebral) vascular stent of the present invention may have one or more ISMs, each ISM having various sensors capable of detecting and distinguishing between normal vascular healing and types of stenosis, restenosis, and / or thrombosis. For example, as... Figure 11 Generally speaking, an ISM can be contained within or above the strut or tip of a vascular stent and can include sensors that detect blood flow, fluid pressure, and blood volume on the luminal surface, enabling them to detect the presence and location of stenosis due to increased blood flow velocity and increased blood (and pulse) pressure at the site of stenosis (relative to normal pressure). Stenosis caused by neointimal hyperplasia or clot formation can be detected as a “dead spot” on the luminal surface and / or a change in reading, while an ISM with blood flow sensors, blood metabolism and / or blood chemistry sensors that become covered by vascular tissue or clots will no longer obtain readings; however, “upstream” sensors will show increased pressure and decreased flow velocity, while “downstream” sensors from the occlusion will show decreased pressure and increased flow velocity (“jet” effect). ISMs with metabolic and chemical sensors can determine the difference between stenosis (normal pH and physiological readings) and clots (decreased pH and changed physiological readings). Finally, with no changes in pressure, blood flow velocity, stent deformation, and metabolic / chemical readings, complete coverage of the stent's luminal surface suggests normal healing; the stent has become endothelialized (covered with cells that make the body's blood vessels linear). The indicators of stent health and complete integration into the vessel wall (i.e., the stent is no longer exposed to elements of the bloodstream) have important clinical outcomes—it warns clinicians that discontinuing a patient's (expensive and dangerous) anticoagulation therapy may be possible because the risk of subacute and delayed thrombosis is now significantly reduced. In the case of biodegradable stents, complete coverage of the stent's luminal surface and integration of the stent into the vessel wall mean that stent dissolution is now safe (i.e., stent fragments will not be released into the bloodstream).

[0189] Furthermore, subjects requiring stents often have extensive cardiovascular disease leading to impaired cardiac and circulatory function. For example, stent recipients have an increased risk of myocardial infarction (heart attack), stroke, congestive heart failure, kidney failure, and arrhythmias. Coronary arteries are critical for cardiac function; therefore, monitoring certain hemodynamic and metabolic parameters within these arteries can provide clinicians with crucial information about a subject's cardiac, renal, and circulatory function. The coronary stent of the present invention may comprise one or more intravascular coronary artery sensor (ISM) equipped with fluid pressure sensors, contact sensors, positioning sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, accelerometers, mechanical stress sensors, temperature sensors, etc., suitable for such purposes. Representative stents of the present invention can be used by those skilled in the art to calculate and monitor important physiological parameters such as cardiac output (CO), stroke volume (SV), ejection fraction (EV), systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), total peripheral resistance (TPV), and pulse pressure (PP). For example, FloTrac / Vigileo (Edwards Life Sciences, Irvine, California) uses pulse contour analysis to calculate stroke volume (SV) and systemic vascular resistance (SVR); the pressure recording analysis method (PRAM) is used by Most Care (Vytech, Padua, Italy) to estimate cardiac output (CO) based on analysis of arterial pressure waveforms. Changes in cardiac output (CO), stroke volume (SV), ejection fraction (EF), and cardiac index (CI) can be important in detecting complications such as myocardial ischemia and infarction; they can also assist clinicians in implementing and adjusting cardiac medications and dosages. ISMs with pulse pressure sensors, pulse contour sensors, and heart rate sensors, contained on and within the stent of this invention, can assist in the detection and monitoring of arrhythmias and heart rate abnormalities; they can also be used to monitor a subject's response to cardiac medications that affect heart rate and rhythm. Readings of systolic blood pressure (sBP), diastolic blood pressure (dBP), mean arterial pressure (mAP), systemic vascular resistance (SVR), and total peripheral resistance (TPV) can be used by clinicians to monitor the dosage and effectiveness of antihypertensive and vasopressor medications. Notably, peripheral and cerebral vascular stents implanted in other arteries (renal, iliac, femoral, carotid, etc.) can also monitor almost all of the aforementioned cardiac / vascular parameters.

[0190] The vascular stent of the present invention may include an ISM with a circulation sensor (as described herein) and blood chemistry and metabolism sensors suitable for monitoring renal function. Examples of blood chemistry and metabolism sensors used in this embodiment include, but are not limited to, blood urea nitrogen (BUN), creatinine (Cr), and electrolytes (calcium, potassium, phosphate, sodium, etc.). Furthermore, the combination of metabolic data with hemodynamic data and urine analysis allows clinicians to calculate the glomerular filtration rate (GFR), a very useful measure of renal function. This information will be particularly useful in the management of dialysis patients to monitor the duration, effectiveness, and frequency of dialysis treatment.

[0191] In one embodiment of the invention, the stent may also include an ISM having one or more temperature sensors. These sensors can be used to track discrete temperatures of the blood, vessel walls, and surrounding environment, as well as temperature changes over time. Such temperature changes can be used to diagnose potential infections (or other diseases or conditions) and allow physicians or caregivers to treat infections (or other diseases or conditions) before they fully develop.

[0192] B.2.B. A bracket with a sensor located within the bracket. As described above, in various aspects of the invention, an ISM having a sensor as described herein may be contained within a support, including, for example, within a tip of the support, within a hole in a strut of the support, or within the strut itself. As used herein, "hole" should be understood to include an opening that passes entirely through the support, as well as cavities, recesses, wells, or other openings or partial openings that allow insertion of the sensor within the support. Representative examples of supports include those described in U.S. Patent Nos. 7,208,010 and 7,179,289.

[0193] In other embodiments, the ISM is designed to be placed within, on, or on a support, and one or more individual sensors communicate with the ISM placed within, on, or on the support.

[0194] B.2.C. Placement, deployment, and connection of the support structure In some embodiments, the stent of the present invention can provide sensing information to serve a variety of important clinical functions. It is generally accepted that the greater the amount of trauma to the vessel wall during stent placement and deployment, the higher the likelihood that the stent (often due to restenosis) will eventually become blocked. Causes of vascular trauma during placement include inaccurate sizing (stent too large for the vessel), difficulty in placement and deployment (requiring extensive manipulation to place the stent), long lesions, overlapping stents, overinflation of the balloon or overexpansion of the stent, complex lesions (including stent placement at branch points), and placing the stent in a tortuous vessel. Accurate placement, sizing, deployment, and full expansion of the stent remain a challenge, particularly in the vascular system, where primarily indirect visualization techniques (such as angiography) are used for stent localization; angiography (a dye that is opaque to X-rays and permeates the blood flow) only shows the anatomy within the vessel lumen and does not provide information about the anatomy of the vessel wall (which is often the critical lesion segment being treated) and only limited information about the stent itself. Real-time sensing information from a stent containing an ISM is useful for clinicians during stent placement to determine: whether the stent is anatomically correct, whether the stent is properly sized for the vessel in which it is placed, whether the stent fully opens (deploys) during balloon dilation (or self-dilation), whether the stent applies too much (or too little) pressure to the vessel wall, whether the stent segments are correctly assembled, whether there is optimal overlap between adjacent stents, whether the stent is kinked or deformed, whether the stent is ruptured or broken, and whether there is uniform flow through the device (to name just a few important functions). The stent of this invention allows the operator to monitor many valuable parameters that lead to better and less invasive stent placement and deployment.

[0195] Improper stent placement relative to the vessel wall in which it is placed can significantly increase the risk of failure (particularly due to restenosis); stents with an ISM sensor capable of detecting the amount, presence, and / or absence of contact and pressure with the vessel wall can assist in matching stent size and expansion (deployment) to the size and expansion of the vessel wall. Incomplete opening of the stent (referred to as "incomplete misalignment"—the area where the stent does not fully contact the vessel wall and protrudes into the arterial lumen) increases the risk of subsequent coagulation (thrombosis) and stent failure. Positioning sensors, contact sensors, and accelerometers of the ISM contained within the stent can be used to identify and correct incompletely opened (deployed) areas during stent insertion and to confirm that the stent is "locked" in a fully opened position. Improper stent placement (misalignment) during placement or due to subsequent movement / migration is also a common complication of stent therapy. The stent containing an ISM sensor of the present invention can be used to confirm proper initial placement within the vessel and any subsequent migration or repositioning. Stent movement as a whole or dislodgement of individual stent segments is another problematic complication of stent insertion and continued treatment. The stent of this invention has the ability to detect movement / dislodgement of the entire stent as well as movement and / or dislodgement of individual segments (or fragments), providing valuable diagnostic information to clinicians and patients. Stent kinking during deployment and / or due to subsequent movement after placement is also a significant clinical problem when it occurs. The stent of this invention has an ISM component containing positioning sensors and an accelerometer distributed to detect stent deformation and kinking. Stent rupture and breakage can be a problem with all stents, but is particularly problematic in peripheral stents of the lower extremities (due to limb movement or bending of stents across the knee joint) and in (coronary, peripheral, and non-vascular) polymeric biodegradable stents, which can become fragile during the polymer degradation process. The ISM, located within the stent device and incorporating vibration sensors, positioning sensors, position sensors, and an accelerometer, can warn clinicians and patients of the development of a complication before it progresses to an acute emergency.

[0196] In various aspects of the invention, components are provided in which a stent may consist of a single component combined with another stent, or of multiple components that need to be placed in a suitable configuration to ensure proper utility. When a patient has arterial disease and vascular stenosis at a branch point in the vascular tree, it is often necessary to use a stent (or stent component) that can be placed together in situ to match the anatomy of the obstructed segment. For example… Figures 9A-9H This is a schematic diagram of various types of multi-bracket placements, where an ISM with contact sensors can be used to ensure the proper placement, configuration, and attachment (overlap) of various bracket segments. Figure 9A The diagram illustrates the locations of narrowing and bifurcation at multiple points within the blood vessel. Figure 9B The illustration shows a bracket with PTCA (as well as ISM and representative sensors). Figure 9C The illustration shows the support bracket unfolded (also known as "reverse T"). Figure 9D The illustration shows the support bracket unfolded (referred to as a "T-bracket"). Figure 9E The illustration shows the deployment of the support plus support, referred to as "compression" (along with the ISM and representative sensor). Figure 9F The illustration shows the bracket-plus-bracket deployment, referred to as “Y” or “V” (along with the ISM and representative sensor). Figure 9G The illustration shows the unfolding of a support structure known as the "kissing" system. Figure 9H The illustration shows the deployed support structure, referred to as the "skirt," along with the ISM and representative sensors. In each case, the support contains the ISM, which has multiple sensors ( Figures 9A-9H The "star-shaped" sensor array includes contact sensors (potentially "matching" or "complementary" for adjacent or overlapping stents) for confirming accurate positioning and assembly; accelerometers for confirming anatomical location and conformation; positioning sensors for monitoring movement; flow sensors for verifying vessel patency; and pressure / vessel wall sensors for verifying full deployment and accurate stent length. In summary, this sensing information creates a 3D image of the vessel and stent anatomy and significantly improves upon data obtainable solely from angiography. This greatly increases the chances of accurate, safe, and effective deployment of multiple stents in complex vascular lesions.

[0197] Figure 10 It is an ISM sensor that can be used to assist and / or aid in the placement of overlapping supports. Figure 10 A schematic diagram of a "star" shape. Overlapping stents are used in the treatment of long or tortuous lesions, where a single stent is insufficient to span the entire length of the lesion segment. While overlapping stents are generally effective, they are more prone to failure, and the failure rate is directly proportional to the degree of overlap between adjacent stents; too much overlap increases the risk of failure, while too little overlap (especially if there is a gap between the two stents) is equally problematic. Stents incorporating an ISM with contact sensors can be used to confirm both the presence and extent of overlap between adjacent stents. In a preferred embodiment, the ISM contact sensors between stents are "matched" or complementary, confirming when the ideal amount of overlap is achieved between adjacent stents. Furthermore, the pressure sensor, positioning sensor, and accelerometer of the ISM can be used to confirm that the overlapping segments are equally deployed to ensure there is no "mismatch" in lumen size between the two stents that overlap.

[0198] B.2.D. Partially or completely biodegradable scaffolds As described above, the stents of the present invention (including, for example, blood vessels (e.g., coronary arteries, carotid arteries, cerebral arteries, vertebral arteries, iliac arteries, femoral arteries, and lower limb arteries), gastrointestinal tract (e.g., esophagus, duodenum, colon, bile ducts, and pancreas), lungs (e.g., for maintaining an open trachea, bronchi, or bronchioles), head and neck (sinuses, lacrimal glands, periosteal stomas), and genitourinary organs (e.g., ureters and urethra, prostate, fallopian tubes) may be composed of one or more biodegradable polymers. Such stents may be wholly or partially biodegradable and / or reabsorbable. Representative examples of such stents include, for example, U.S. Patent Applications Nos. 2009 / 0192588, 2007 / 0270940, and 2003 / 0104030 and U.S. Patents Nos. 6,387,124, 6,869,443, and 7,044,981).

[0199] The placement of an ISM having sensors as described herein, above or within a biodegradable or partially biodegradable stent (at different depths within a polymer), allows for the determination of stent degradation, and optionally, the rate of stent biodegradation or reabsorption. Therefore, in one aspect of the invention, a method for determining stent degradation is provided, comprising the steps of: a) providing a body passage of a subject with an assembly including a stent and one or more ISMs having sensors, and b) detecting changes in the sensors to determine stent degradation. In various embodiments, the ISM has sensors capable of detecting one or more physiological (e.g., contact, fluid flow, pressure, and / or temperature) parameters and / or positional (e.g., location within the subject) parameters. In other embodiments, the detection steps are a series of detections over time, and optionally, the method may further include steps of determining the stent degradation rate and / or estimating the time to complete stent degradation. In still other embodiments, the stent may be assessed by healing tissue to determine intraluminal coverage of the device, thereby confirming that the stent is embedded within the vessel wall (reducing or eliminating the possibility of stent fragment release into the intraluminal fluid).

[0200] In one embodiment, the biodegradable stent is a stent for the esophagus, ureter, urethra, sinus, blood vessel, or prostate, and stent degradation can be monitored by detecting the loss or movement of the ISM sensor over a period of time.

[0201] B.2.E. Support Coating In some embodiments of the invention, the scaffold provided herein may have one or more coatings on one or more surfaces of the scaffold. Coatings may be provided on the scaffold for various purposes. The coatings may be biodegradable or non-biodegradable or a combination thereof. Typically, many coatings are polymer-based (e.g., polymers composed of polyurethane, polyester, polylactic acid, polyamino acids, polytetrafluoroethylene, tephlon, Gortex®), although non-polymer coatings may also be used.

[0202] Representative examples of suitable coatings include those described, for example, in U.S. Patent Nos. 8,123,799, 8,080,051, 8,001,925, 7,553,923 and 5,779,729, all of which are incorporated herein by reference in their entirety.

[0203] B.3. Prosthetic Hip Joint In one embodiment of the invention, a prosthetic hip joint having one or more ISMs as described herein is provided. Briefly, the term "hip replacement" as used herein can take many different forms and can involve replacing all or part of a patient's hip joint with synthetic materials. In total hip replacement (THR), both the femoral head and acetabulum are replaced. In partial hip arthroplasty, only the femoral head is replaced, while the patient's own acetabulum is preserved. The femoral component of a hip replacement can be a single piece having a head and stem as a single, complete unit, or it can be constructed as several parts, such as a femoral stem which is then coupled to a separate femoral head component and neck segment (which is typically used to provide a custom fitting for the patient with the length and / or size of the femoral head). The femoral component can be glued into place with PMMA bone bonding agent (glued hip), or it can be precisely installed within the medullary canal of the femur and held in place without bonding agent (AML - anatomical medullary locking - stem design). Similarly, the acetabular component of a THR can be a single piece attached to the acetabular socket to receive the femoral head, or it can be a two-piece component with a shell attached to the pelvic bone and an inner liner attached to that shell. The acetabular component of a THR can be held in place with screws and / or adhesive, or it can be fixed without adhesive.

[0204] Currently, various components can be made from the same material; for example, all parts can be made of metal, or individual components can be made from various different materials. For example, it is common for acetabular components to have a metal shell and liner, the metal shell having an outer surface coating to promote bone attachment and inward growth, and the liner being made of polyethylene, ultra-high molecular weight polyethylene, ceramic, or surgical-grade stainless steel. Similarly, several different combinations of materials can exist for the construction of the femoral head. For example, the femoral head can be composed of a metal typically cobalt-chromium (but also stainless steel or titanium) or a ceramic material, while the femoral stem is typically metal (stainless steel, titanium, or cobalt-chromium) and usually has a surface coating to promote implant integration within the femur.

[0205] As used herein, unless the specific context requires otherwise, the terms “hip implant,” “prosthetic hip,” “hip replacement,” “hip replacement or partial replacement thereof,” or “medical device” shall be understood to refer to any or all of the various components that make up a total hip prosthesis, including, for example, the femoral stem, femoral head, and acetabular assembly, and their various sub-components. “Hip replacement prosthesis” shall be understood to refer to a partial or total hip replacement prosthesis.

[0206] In various embodiments of the invention, one or more ISMs and / or sensors may be placed on or within the hip replacement. Representative examples of sensors placed on the hip replacement are provided in PCT application number PCT / US2014 / 028323, which is hereby incorporated herein by reference in its entirety.

[0207] B.3.A. Medical uses of hip replacement Hip replacement surgery is performed when a patient loses full use of their hip, resulting in disability, loss of mobility and function, impaired walking, and / or persistent joint pain and discomfort. Common causes of impaired hip function following total or partial hip replacement include trauma (usually a hip fracture; typically at the femoral neck), avascular necrosis of the hip, or various types of arthritis (such as rheumatoid arthritis or osteoarthritis). In most patients, the surgery successfully improves walking, restores function, and reduces pain; therefore, it is one of the most common orthopedic surgical procedures in the Western world.

[0208] B.3.B. Representative Examples of Hip Implants Hip replacement prostheses are described in more detail in PCT application number PCT / US2014 / 028381, which is hereby incorporated herein by reference in its entirety. In short, a prosthesis typically consists of an acetabular shell in which the acetabular liner is placed. It also includes a femoral assembly comprising two parts, a femoral head and a femoral implant or femoral stem (also having a femoral neck) (see General). Figure 12 ).

[0209] One or more ISMs with sensors can be positioned within the prosthesis to monitor patient activity and prosthesis performance in situ in real time. In one embodiment, an ISM with contact sensors can be placed within the acetabular shell. These sensors detect and record contacts between adjacent parts, such as the contact between the acetabular shell and the pelvis and / or the contact between the acetabular shell and the bone bonding agent (if present) and / or the contact between the bone bonding agent (if present) and the pelvis, and can detect prosthesis loosening and its connection with the surrounding bonding agent (if present) and / or pelvic bone. Acetabular loosening is a common complication (typically lasting more than 8–12 years) that occurs when bone loss (e.g., due to a process known as osteolysis) occurs in the pelvic bone around the acetabulum. Bone erosion around the implant can be caused by material fragments (metal, ceramic, and / or polyurethane fragments) generated by friction between the femoral head and the acetabular cup entering the pelvic tissue around the acetabulum and causing inflammation and bone loss. Other potential causes of inflammation and bone resorption include implant vibration and movement, mechanical wear, lack of biocompatibility between the implant material and surrounding bone, metal allergy, and lack of biocompatibility between the bone bonding agent and surrounding bone. Additionally, an ISM with a contact sensor can indicate that the acetabular shell is positioned further away from the pelvic bone than desired due to the accumulation of material debris over time and / or the presence of inflammation between the shell and the pelvic bone. An ISM with a contact sensor can also be placed within the bone bonding agent (if present) to collect data on the physical contact between the bone bonding agent and the acetabular prosthesis and / or between the bone bonding agent and the pelvic bone.

[0210] In various embodiments, the ISM with contact sensors can also be positioned at various locations on both surfaces of the acetabular liner. Thus, the contact sensors can sense contact (and / or movement) between the acetabular liner and the acetabular shell (these sensors can be "paired" to detect offset between the acetabular liner and shell), as well as contact between the femoral head and the acetabular liner. Similarly, the ISM with contact sensors can be positioned at various locations on the femoral head to detect contact between the femoral head and the acetabular liner. Therefore, in embodiments, ISMs with various contact sensors are provided to monitor contact between the bone and acetabular components and between the femoral head and the acetabular liner. Dislocation of the femoral head from the natural or synthetic acetabulum of a prosthetic hip is a common complication of hip replacement surgery, particularly when the surrounding supporting tissues have healed surgically; if joint dislocation occurs, ISM sensors on the femoral head and / or acetabulum can alert the patient and healthcare provider. Partial or incomplete dislocation of the hip joint (subluxation) can also occur and may not be obvious to the patient or physician; contact sensors on the femoral head and / or acetabulum can determine whether the joint is functioning correctly (tracking) and whether a subluxation has occurred (even if it is subclinical or asymptomatic).

[0211] Additional (or alternative) ISMs with contact sensors may also be positioned above or within the femoral stem to monitor contact between the femoral stem and femur and / or contact between the femoral stem and surrounding bone bonding agent (if present). ISMs with contact sensors above and / or within the femoral shaft can detect prosthesis loosening and its connection to surrounding bonding agent (if present) and / or femur. Loosening of the femoral shaft is a common complication (typically lasting more than 8–12 years) that occurs when bone loss due to osteolysis occurs in the femoral canal around the femoral shaft. As mentioned above, bone erosion around the implant can be caused by material fragments (metal, ceramic, and / or polyurethane fragments) generated by friction between the femoral head and acetabular cup entering the femoral tissue around the femoral prosthesis and causing inflammation and bone loss. Other potential causes of inflammation and osteolysis include implant vibration and movement, mechanical wear, lack of biocompatibility between the implant material and surrounding bone, metal allergy, and lack of biocompatibility between the bone bonding agent and surrounding bone. Additionally, ISMs incorporating contact sensors can be used to detect and record contacts between connecting components in modular femoral prostheses, such as the femoral head, femoral neck, and / or femoral stem. These ISMs can be used to ensure that the connecting elements of the modular femoral prosthesis are correctly aligned and assembled.

[0212] In other embodiments, an ISM with strain gauges can be positioned at various locations above or within the prosthesis, particularly the femoral stem, and also at various locations above or within the femoral neck and head, to detect strain between the prosthesis and the surrounding bone. A decrease in strain can indicate the presence of bone resorption (loss), which can lead to prosthesis loosening or fracture. Strain sensors provide different data points than contact sensors, which only indicate whether there is electrical contact between adjacent structures and thus provide a good indication of whether there is abutment contact between two surfaces. However, contact sensors do not provide an indication of strain present on either surface, whereas strain sensors output data indicating the mechanical strain force applied across the implant, which, if not corrected, may be a precursor to future loosening and prosthesis failure. Additionally, an ISM with strain gauges can indicate the type of strain exhibited between two surfaces, such as between the acetabular liner and the pelvic bone, or between the acetabular shell and the acetabular liner.

[0213] In other embodiments, the ISM is equipped with an accelerometer that can be positioned at various locations within and above the femoral shaft, femoral neck, and femoral head. The accelerometer provides the advantage of being able to detect acceleration, vibration, impact, tilt, and rotation of the individual components. It allows for the measurement of prosthesis performance under various conditions and over long periods of time.

[0214] Shortly after hip replacement, the leg will initially be passively moved, followed by actively; soon after, the patient will gradually begin to bear weight on the joint. An ISM accelerometer will measure movement of the iliac fossa during movement, including walking as the leg swings forward, impacts the ground, settles, leaves the ground, and propels the body forward. Additionally, the accelerometer will measure the impact force of the foot striking the ground and the effects of the forces transmitted through the femur to the pelvic bones, as well as any vibrations, shocks, or rotations that may occur at different locations within the prosthesis. As the patient's range of motion continues to improve post-surgery, the acceleration experienced at different locations within the prosthetic hip joint can be monitored. It will be expected that as the patient heals surgically, activity levels will gradually increase, walking will improve, gait will become faster (and smoother), and, additionally, stride length will be achieved. This may result in a greater impact force with each foot impact, which can be measured over time (and compared with previous values) using various accelerometers positioned on the femoral head, in the femoral stem, and / or other locations on the prosthesis. Postoperative progress can be monitored (readings compared daily, weekly, etc.), and the information is compiled and transmitted to both the patient and the attending physician, allowing for sequential tracking of recovery and comparison with expected (typical population) norms. In some embodiments, the wearable device queries sensors on a selected or random basis and captures and / or stores the collected sensor data. This data can then be downloaded to another system or device (as described further in detail below).

[0215] In some embodiments of the present invention, the ISM is such as Figure 13 The illustrated single-element implantable device. For ISMs that collect mechanical data (position, motion, vibration, rotation, impact, tilt, gait), the implanted ISM sensors (accelerometer, positioning sensor, pedometer) have the advantage of not requiring direct physical contact with the device surface or patient tissue; only a safe and fixed attachment within the prosthetic joint is needed. In a particularly preferred embodiment, the ISM containing multiple mechanical sensors (as described above) is placed within the inner cannula of the femoral stem; this location provides sufficient space for inserting and sealing the ISM with multiple sensor functions and battery capacity. Furthermore, the movement of the stem throughout the hip joint during normal activities (e.g., walking) can provide an opportunity to power the ISM.

[0216] In the ISM, the sensors used for contact, strain, and accelerometers can be those that are generally available and acceptable as described in this document.

[0217] Integrating data collected by the sensors described herein (e.g., contact sensors, positioning sensors, strain gauges, and / or accelerometers) with simple, widely available commercial analytics techniques such as pedometers and GPS capabilities allows for the collection of additional clinically important data, such as, but not limited to: the extent of patient walking (time, distance, strides, speed, rhythm) under various “real-world” conditions, patient activity levels (activity frequency, duration, intensity), exercise tolerance (work, calories, strength, training effect), range of motion (discussed later), and prosthesis performance. It is difficult to overstate the value of this information in achieving better management of patient rehabilitation. The attending physician (or physical therapist, rehabilitation specialist) observes the patient only briefly during scheduled visits; at the exact moment of examination, the extent of the patient's function may be influenced by a variety of different factors, such as: the presence or absence of pain, the presence or absence of inflammation, stiffness, time of day, adherence to and duration of medication use (analgesics, anti-inflammatory drugs), recent activity and exercise levels, patient intensity, mental state, language impairment, the nature of their doctor-patient relationship, or even the patient's ability to accurately express their symptoms (to name just a few). Continuous monitoring, or monitoring at repetitive periodic intervals, as a means of managing battery life and collecting data, allows patients and physicians to objectively monitor progress by providing information about the patient's function in many conditions and situations. This includes assessing how performance is affected by various interventions (pain control, exercise, physical therapy, anti-inflammatory drugs, rest, etc.) and comparing rehabilitation progress with previous and expected future function. When both physicians and patients benefit from observing the impact of various treatment modalities on the patient's rehabilitation, activity, function, and overall performance, better treatment decisions and better patient adherence can be expected.

[0218] As will be apparent from the disclosure provided herein, the ISM described and claimed herein may include various different sensors located at different positions within and above the prosthetic hip. Additionally, in various embodiments of the invention, one or more sensors may be placed separately from the ISM (but optionally, may still be capable of communicating with and being controlled by the ISM). Representative examples of sensors placed on the hip prosthesis are provided in PCT application number PCT / US2014 / 028381, which is hereby incorporated herein by reference in its entirety.

[0219] B.3.C. Coating on hip implants In some embodiments of the invention, a hip implant is provided which may have one or more coatings on one or more surfaces of the prosthesis. The coatings may be disposed on the hip implant for various purposes. The coatings may be biodegradable, non-biodegradable, or a combination thereof. Representative examples of coatings are polymer-based (e.g., polymers composed of polyurethane, polyester, polylactic acid, polyamino acids, polytetrafluoroethylene, tephlon, Gortex®), although non-polymer coatings may also be used. In some embodiments of the invention, one or more ISMs containing sensors, as described herein, may be distributed throughout the coating (e.g., even in a random manner).

[0220] B.4. Prosthetic knee joint In one embodiment of the invention, a knee replacement having one or more ISMs as described herein is provided. In short, the terms "knee replacement" or "knee prosthesis" as used herein can take many different forms and can involve replacing a patient's entire knee joint (total knee replacement) or part of it (partial knee replacement) with synthetic materials. In a total knee replacement (TKR), both the femoral and tibial sides are replaced. In a partial or single-compartment knee replacement, only one or two parts of the knee are replaced (surface - tibia or femur; or compartment - medial, lateral, or patella).

[0221] The various components of a TKR typically include a femoral implant, a patellar implant, and a tibial implant (which may consist of a tibial plate and a tibial liner with or without a stem). Currently, these components can be made from a variety of different materials, including, for example, polyethylene, ultra-high molecular weight polyethylene, ceramics, surgical-grade stainless steel, cobalt-chromium, titanium, and various ceramic materials. In some devices, the femoral implant (typically made of metals such as stainless steel, titanium, or cobalt-chromium) may be designed with a bone surface coating to facilitate implant integration into the femur, and the tibial plate (and stem) may also have a surface coating to facilitate integration into the tibia. Representative examples of the various components of knee replacement are described in U.S. Patent Nos. 5,413,604, 5,906,643, 6,019,794, and 7,922,771.

[0222] "Bone bonding agent" refers to a material that can be applied between the prosthesis hardware and the surrounding bone and hardens in place upon cooling (or otherwise activated); it is a reagent used to anchor one or more components of the prosthesis (prosthesis femoral surface, tibial plate / stem, patellar "button") to the appropriate bone tissue (femur, tibia, tibial medulla, patella). Bone bonding agents are typically composed of PMMA (polymethyl methacrylate) or blends of PMMA and MMA copolymers. It should be noted that bone screws and / or other metal (or polymer) fixation devices can also be used to assist in anchoring prosthetic components to the surrounding bone tissue.

[0223] This invention provides knee prostheses (which may include all or part of the implant), medical devices (e.g., a portion of the knee implant, and / or components or materials useful during implantation), and kits (e.g., knee prostheses, medical devices, and additional necessary materials, such as bone bonding agents and any associated delivery devices), all of which may have one or more of the ISMs provided herein. Preferably, the knee prostheses, medical devices, and kits (including associated materials such as bone bonding agents) provided herein are sterile, pyrogen-free, and / or suitable for use in humans and / or implantation into the human body. However, in some embodiments of the invention, the knee prostheses, medical devices, and / or kits may be manufactured in a non-sterile environment (or even customized for an individual subject) and sterilized at a later point in time.

[0224] B.4.A. Knee prostheses, medical devices and kits and their use Knee replacement surgery is performed when a patient loses full use of their knee, resulting in disability, loss of mobility and function, impaired walking, and / or persistent joint pain and discomfort. Common causes of impaired knee function leading to total or partial knee replacement include various types of arthritis (such as rheumatoid arthritis or osteoarthritis) and trauma (e.g., previous ligament injuries or cartilage / meniscus tears). In most patients, the surgery successfully improves walking, restores normal daily function, and reduces pain; therefore, it is a very common orthopedic surgical procedure in the Western world.

[0225] Figure 14 Total knee arthroplasty of known types in the art, as well as single-compartment (medial compartment) knee replacement, are shown. Figure 15A The illustration shows the components and materials of a typical artificial joint K10, including a metal tibial plate K5 and a tibial stem K2 (although some tibial plate components do not have a stem, they are present in this illustration), a polyethylene hinged surface K7, a bonding agent K4 for holding the various components in place, a patellar "button" prosthesis K8, and a femoral knee component K9.

[0226] In one embodiment of the invention, the ISM may be placed within the tibial extension. For example, as... Figure 15B Part of the artificial joint shown may be made of a tibial plate ( Figure 15C T1) and tibial extension ( Figure 15C Composed of T2. Tibial extension ( Figure 15DThe device may consist of various aspects, including a screw engagement T3, a first portion T4, and a second portion T5, the second portion of which may optionally be ribbed to aid bone engagement. It is also understood that the screw engagement T3 may alternatively be constructed as a press-fit cylinder, a threaded cylinder, or other means that can be accommodated in a mating unit on the tibial plate to produce a fixation effect. In some embodiments of the invention, the ISM as described herein may be placed within the tibial extension (e.g., within portion T4). In some embodiments, the extension is formed as two parts having a joint located at the maximum external dimension of T5. The tibial extension containing the ISM (e.g., T4a) may be sealed at the joint using adhesive, threads, ultrasonic welding, or any combination thereof. In other embodiments, a battery (e.g., T5a) powering the ISM may also be placed within the body of the tibial extension (e.g., within portion T5). Although in Figure 15D The standard battery T5a is provided for illustrative purposes only, but the battery can also be designed to have a shape conforming to the ribbed segment in order to maximize the battery volume and thus its power capacity. Such a shape also provides the additional benefit of suppressing the rotation of the battery within the tibial extension when the joint is in motion. It is also understood that the tibial extension containing the ISM can be configured as an extension for any total arthroplasty joint, wherein the extension is placed into the medullary canal of the bone for placing the arthroplasty device in the patient's body. The particularly preferred ISM for use in this aspect of the invention can be made of flexible circuitry (e.g., as shown in the image). Figure 15D As shown in T4a), and has an accelerometer and gyroscope for measuring the movement of the artificial joint. Additionally, an ISM suitable for use herein may include one or more of the following: a temperature sensor, a magnetometer, a radio transceiver, an energy harvester, a signal processor, a microcontroller, and a piezoelectric sensor.

[0227] Figure 16 Another typical TKR is depicted, which has a femoral component, tibial plate, tibial liner, and patellar button that can be attached to the underlying bone with screws and / or adhesive (in Figure 16 In this process, the tibial plate is attached to the tibia by screws and / or adhesive, as shown in the image. Figure 15A (The stalked tibial plate depicted in the text is the opposite).

[0228] Figure 17 The illustration shows a representative prosthesis with one or more ISM 10 points positioned within or above the prosthesis for in-situ monitoring of the prosthesis's real-time operation, patient function and activity levels, and acute and time-over-time prosthesis performance. Note that in knee prostheses containing a tibial stem (such as in...) Figure 15A (In the middle), the inner cannula of the tibial stem is the preferred location for placing the ISM.

[0229] As an example, one or more ISMs with contact sensors may be provided for placement or attachment on or within the tibial component (liner, plate, or stem), femoral component, and / or patellar component (“button”) of the knee prosthesis. The ISM may also be contained within the osteosynthetic adhesive, if present.

[0230] In other aspects of the invention, a method is provided for imaging a knee replacement or medical device comprising one or more ISMs as provided herein, comprising the steps of: (a) detecting the position of one or more sensors within the ISMs in the knee replacement or medical device; and (b) visually displaying the position of the one or more sensors, such that an image of the knee replacement or medical device is created. In various embodiments, the detection step may be performed over time, and thus the visual display may show positional movement over time. In some preferred embodiments, the image displayed is a three-dimensional image.

[0231] The imaging techniques provided herein can be used for a wide variety of purposes. For example, in one aspect, the imaging techniques can be used during surgical procedures to ensure proper placement, alignment, and operation of knee replacements or medical devices. In other embodiments, the imaging techniques can be used postoperatively to examine knee replacements or medical devices and / or compare the operation and / or movement of the device over time.

[0232] In one embodiment, a prosthetic knee comprising one or more ISMs equipped with contact or pressure sensors can be used to detect loosening of the prosthesis and its connection with surrounding adhesive (if present) and / or bone. For example, an ISM with contact or pressure sensors located above / inside the tibial component (and / or above / inside the bone adhesive surrounding the tibial component) can detect loosening of the tibial component within the tibia; this can be acutely detected during surgery and alert the surgeon to the need for some intraoperative adjustments. Progressive loosening of the tibial component within the tibia over time (compared to the postoperative level) is a common complication that occurs when bone loss (e.g., due to a process known as osteolysis) occurs; this can also be detected by contact or pressure sensors in ISMs located above / inside the tibial component (and / or above / inside the bone adhesive surrounding it). In addition, ISM contact sensors or pressure sensors located between segments of the tibial component (e.g., between the tibial plate and the tibial liner) can detect abnormal movement, loosening, or wear between component segments; these sensors can be “matched” (i.e., “paired” between adjacent components) to further allow for accurate assembly during (and after) surgical placement.

[0233] Therefore, in one embodiment, an ISM with contact or pressure sensors is provided to monitor contact between tibial and tibial components, between femoral and femoral components, between patellar and patellar components, between complementary segments of the individual prosthetic components, and between the various articular surfaces (medial and lateral tibiofemoral joints; patellofemoral joints) of a multi-compartment or single-compartment prosthetic knee joint. Specifically, complete or partial dislocation (subluxation) of the femoral prosthesis articular surface with the natural or synthetic tibial articular surface (medial, lateral, or both) of the prosthetic knee is a common complication of knee replacement, typically occurring shortly after surgery (especially during the postoperative recovery period while surrounding muscles and ligaments are still healing from the surgery). If joint dislocation or subluxation occurs, the ISM contact sensors on the femoral component articular surface and / or the tibial component articular surface can alert the patient and healthcare provider. This is particularly valuable in detecting subclinical partial or incomplete dislocations (subluxations) of the knee joint that may not be apparent to the patient or physician; this is of utmost concern during early mobilization and postoperative rehabilitation efforts. Additionally, an ISM with contact or pressure sensors on individual knee components can determine whether the joint is functioning and aligned (tracking) correctly during movement and activity. This is especially true for knee movement, as accurate patellar tracking can be difficult to measure clinically; accurate measurement of patellar tracking during and after surgery will be beneficial.

[0234] In other embodiments, an ISM having one or more strain gauges (or sensors) is disposed above and / or within, for example, the femoral condyle prosthesis-bone interface, the tibia-plate (and stem (if present)) interface, and the patellar prosthesis (patellar "button")-patellar interface. In some embodiments (and to the extent space permitting), the ISM with strain gauges may be contained above / within a bone bonding agent (if present) for securing the prosthesis to the surrounding bone, and in other embodiments, the strain gauges are contained above / within both the prosthesis component and the bone bonding agent (PMMA).

[0235] In various embodiments, an ISM with strain gauges can be positioned at various locations on the tibial component to detect strain between the tibial prosthesis and the surrounding tibia (and / or bone grafting, if present). Many tibial prostheses include a stalk extending into the medullary canal of the tibia to enhance anchoring and stability. A decrease in strain in the tibial prosthesis and / or tibial bone grafting can indicate the presence of a condition that may potentially lead to bone resorption (loss) in all or part of the tibial canal; bone resorption can lead to prosthesis loosening or tibial fracture (conversely, increased strain will favor bone growth in the area). Therefore, an ISM with strain sensors can provide an indication of the strain present in the tibial shaft and measure the most critical mechanical strain applied across the implant, which, if misaligned or uncorrected, is likely to lead to loosening and prosthesis failure. Increased strain can also indicate bone hypertrophy (growth), which can be a source of pain. The same dynamics exist at the interface between the prosthetic components (and / or bone bonding agent) of the femur and patella and the femur and patella; for these purposes, the strain gauge-equipped ISM of the present invention can also be used for monitoring. “Real-life” strain information is not only beneficial to physicians and patients, who can use this data to determine the (positive and negative) effects of various activities on prosthesis-bone health, but also beneficial to manufacturers, who can use this information to design better prostheses.

[0236] Similarly, in other embodiments, an ISM having one or more accelerometers that can be located throughout the implant is provided, including an ISM with accelerometers distributed above and within the femoral condyle prosthesis, above and within the tibial plate (and stem (if present)) and tibial liner, and above or within the patellar prosthesis (patellar "button"). In some embodiments, the ISM with accelerometers is above / within the prosthesis components themselves (tibial, femoral, and patellar segments), while in other embodiments, the ISM with accelerometers is contained above / within the bone bonding agent (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the accelerometers are contained above / within both the prosthesis components and the bone bonding agent (PMMA).

[0237] The ISM with accelerometer offers the advantage of being able to detect acceleration, vibration, shock, tilt, and rotation of individual components. They allow for the measurement of the performance of the prosthesis K10 under various conditions and over long time periods.

[0238] During knee replacement surgery, the prosthetic joint is moved through a full range of motion and stability tests to assess prosthetic function and mobility before surgical closure. An ISM with an accelerometer provides surgeons with accurate, numerical, and quantitative ranges of motion data at that time; this data can be compared to expected values ​​to assess the effectiveness of the implantation surgery, and it can be used as a baseline for comparison with postoperative functional values. Any abnormalities in vibration (indicating insufficient anchorage of the prosthesis in the surrounding bone), any abnormalities in tilt (indicating improper tracking and / or alignment of the tibiofemoral and patellofemoral joints), any abnormalities in rotation (indicating dislocation or subluxation), and / or any abnormalities in range of motion can be addressed at this time, allowing surgeons to make adjustments intraoperatively. Shortly after knee replacement, the leg will be moved passively first, followed by active leg movement; shortly after recovery from the surgical procedure, the patient will begin to gradually bear weight on the joint. The ISM accelerometer measures knee joint movement and tracking during movement, including walking during forward swing of the leg, impact with the ground, placement, lifting off the ground, and forward propulsion of the body. In addition, accelerometers can measure the impact force of the foot striking the ground and the effects of the forces transmitted through the tibia to the knee joint, as well as any vibrations, shocks, or rotations that may occur at different locations within the prosthesis. As the patient continues to improve their range of motion post-surgery, the acceleration experienced at different locations within the prosthetic knee joint can be monitored. It is expected that as the patient heals through surgery, activity levels will gradually increase, walking will improve and become more frequent, gait will become faster (and smoother), and, in addition, stride length will be achieved. The effects of exercise and various activities can be monitored using various accelerometers and compared with the patient's subjective experience to determine which daily activities are improving (or inhibiting) post-operative recovery and rehabilitation.

[0239] In another embodiment, one or more ISMs containing positioning sensors are provided for inclusion or attachment throughout the implant, including ISMs distributed above and within the femoral condyle prosthesis, above and within the tibial plate (and stem, if present) and tibial liner, and above and within the patellar prosthesis (patellar "button"). In some embodiments, the ISMs containing positioning sensors are above / within the prosthesis components themselves (tibial, femoral, and patellar segments), while in other embodiments, the positioning sensors are included above / within the osteosynthesis (if present) for securing the prosthesis to the surrounding bone, and in still other embodiments, the positioning sensors are included above / within both the prosthesis components and the osteosynthesis (PMMA).

[0240] An ISM equipped with positioning sensors as described herein can be used to provide accurate positional data (intraoperative and postoperative) of the prosthetic knee joint, including measurements of flexion and extension, to improve the accuracy of physical examinations by providing 3D data of the implant to detect complete and partial dislocations (subluxations) of the tibiofemoral (knee) joint and / or patellofemoral joint, and to determine proper tracking and alignment of the knee joint and patella.

[0241] In another embodiment, the ISM may be placed within any polymer component of the medical device. In some embodiments, representative polymers that may be used include polyethylene, highly cross-linked polyethylene, ultra-high molecular weight polyethylene, polyether ether ketone (“PEEK”), carbon fiber reinforced PEEK, and / or vitamin E-stabilized highly cross-linked polyethylene (HXLPE) (as described in more detail below in the section entitled “Medical Polymers”).

[0242] For ISMs that collect mechanical data (position, motion, vibration, rotation, impact, tilt, gait), implanted ISM sensors (accelerometers, positioning sensors, pedometers) have the advantage of not requiring direct physical contact with the device surface or patient tissue; only a safe and secure attachment within the prosthetic joint is needed. In a particularly preferred embodiment, an ISM with multiple mechanical sensors (as described above) is placed within the inner tube of the tibial stem; this location provides sufficient space for inserting and sealing the ISM with multiple sensor functions and battery capacity. Furthermore, the movement of the stem throughout the knee joint during normal activity (e.g., walking) can provide an opportunity to power the ISM.

[0243] Integrating data collected by the sensors described herein (e.g., contact sensors, positioning sensors, strain gauges, and / or accelerometers) with simple, widely available commercial analytics techniques such as pedometers and GPS capabilities allows for the collection of additional clinically important data, such as, but not limited to: patient walking extent (time, distance, strides, speed, rhythm) under various “real-world” conditions, patient activity levels (activity frequency, duration, intensity), exercise tolerance (work, calories, strength, training effect), range of motion, and prosthetic performance. Continuous monitoring, or monitoring at repetitive periodic intervals, as a means of managing battery life and data collection, enables patients and physicians to objectively monitor progress by providing information about patient function under numerous conditions and circumstances, to assess how performance is affected by various interventions (pain control, exercise, physical therapy, anti-inflammatory drugs, rest, etc.), and to compare rehabilitation progress with previous and expected future function.

[0244] As will be apparent from the disclosure provided herein, the ISM described and claimed herein may include various different sensors located at different locations within the ISM. Additionally, in various embodiments of the invention, one or more sensors may be placed separately from the ISM (but still optionally, may be able to communicate with and be controlled by the ISM). A representative example of a sensor placed on a knee prosthesis is provided in PCT application number PCT / US2014 / 043736, which is hereby incorporated herein by reference in its entirety.

[0245] B.4.B. Use of knee prostheses, medical devices, or kits with sensors for measuring the degradation or wear of the implant. As described above, knee prostheses, medical devices, and kits capable of detecting and monitoring implant degradation are provided in various aspects of the present invention. For example, in one embodiment of the invention, a method for detecting degradation of a knee replacement, medical device, or kit is provided, comprising the steps of: a) providing a subject with a knee replacement, medical device, or kit having one or more ISMs including sensors as described herein, and b) detecting changes in the ISM sensors to determine degradation of the knee replacement, medical device, or kit. In various embodiments, the ISM sensors may detect one or more physiological and / or positional parameters. In another embodiment, the ISM sensors may detect contact, fluid flow, pressure, and / or temperature. In yet another embodiment, the ISM sensors may detect position within the subject.

[0246] When a knee prosthesis degrades or is damaged, the ISM sensor can detect changes, allowing for a determination of damage and / or degradation. For example, a sensor previously embedded within the polymer portion of the device may be exposed to fluid forces and pressures not previously present during degradation. Therefore, in a preferred embodiment of the invention, degradation can be detected over a period of time.

[0247] B5. Medical Management In yet another embodiment of the invention, a medical tube having one or more ISMs as described herein is provided. In short, a “medical tube” refers to a generally cylindrical, closed, waterproof body that, as used herein, can be used in a wide variety of medical procedures (e.g., the tube is generally sterile, pyrogen-free, and / or suitable for use in humans and / or implantation in humans). For example, the tube can be used to: 1) bypass obstructions (e.g., in the case of coronary artery bypass grafts or “CABG” and peripheral bypass grafts) or open obstructions (balloon dilation catheters, angioplasty balloons); 2) relieve pressure (e.g., shunts, drainage tubes and catheters, urinary catheters); 3) restore or support anatomical structures (e.g., endotracheal tubes, tracheostomy tubes, and feeding tubes); and 4) access (e.g., CVC catheters, peritoneal and hemodialysis catheters). Representative examples of tubes include catheters (as discussed in more detail below), auditory or eustachian tubes, drainage tubes, tracheostomy tubes (e.g., Durham tubes), endobronchial tubes, endotracheal tubes, esophagus, feeding tubes (e.g., nasogastric tubes or NG tubes), gastric tubes, rectal tubes, colostomy tubes, and a wide variety of vascular grafts (e.g., bypass grafts).

[0248] The tube may be composed of synthetic materials (e.g., silicone, polyurethane, and rubber), non-synthetic components (e.g., harvested venous and arterial grafts for bypass), or some combination of these [e.g., artificial blood vessels with synthetic polymer scaffolds and naturally occurring cells (e.g., fibroblasts) that produce matrix material for the blood vessels (e.g., collagen)].

[0249] As used herein, the term "catheter" refers to a thin tube commonly used in a wide variety of medical conditions and procedures. Typically, they are inserted into body cavities, lumens, tubes, or blood vessels. Catheters are usually inserted into the body by first advancing a flexible metal guidewire to the desired anatomical location; the catheter is then positioned on the guidewire and manipulated into place, after which the guidewire is removed. In this way, they can allow for the drainage or administration of fluids (e.g., saline solutions, medications, etc.), provide access for various medical or surgical instruments, and / or be used to perform a wide variety of surgical procedures (such as balloon catheters for dilating obstructed bodily passages). Catheters can be used temporarily or for extended periods (even permanently) and can have one, two, three, or more lumens or channels.

[0250] Catheters can be composed of a wide variety of materials, including, for example, metals such as nitinol, although most catheters are made of polymers. Catheters can be made of biodegradable or non-biodegradable polymers (or combinations thereof). Typical polymers used in the construction of catheters include silicone, nylon, polyurethane, and polyethylene terephthalate. As will be apparent from the disclosure provided herein, catheters can be designed for their intended use and can be designed in a wide variety of forms and shapes (see, for example, examples of balloon-based catheters). Figure 18 The balloon-based catheter has an ISM equipped with various sensors.

[0251] Catheters can be used for a wide variety of clinical indications and procedures, including, for example, 1) draining fluid or relieving obstruction by placing a catheter through natural body cavities, such as: draining the urinary tract (e.g., bladder or kidney) via the urethra using Foley catheters, intermittent (Robinson) catheters, and ureteral catheters; accessing the GI tract via anal catheters and aspiration catheters; reaching the respiratory system via the nose and mouth using pulmonary catheters; and accessing the reproductive system via the vagina (female) or urethra (male); 2) draining fluid or relieving obstruction through surgically created access to anatomical spaces or cavities; for example, peritoneal catheters. (Placed in the abdominal cavity for ascites, dialysis), chest tube (placed in the pleural cavity for pneumothorax, pleural effusion, chylothorax, infection), pericardial drainage tube (in the heart), CNS drainage catheter or shunt (placed in the cerebrospinal fluid for hydrocephalus, infection, inflammation, obstruction); 3) Drainage catheters, which are placed percutaneously or intraoperatively during surgery to drain sterile fluid or abscesses from any location [drainage catheters can be placed almost anywhere, including the chest (heart, lungs), abdomen (liver, bile duct drainage catheters), knees, hips, urinary tract (ureters, kidneys, prostate, bladder), reproductive...] 4) venous catheters [e.g., peripheral venous catheters, central venous catheters (CVCs), peripherally inserted central venous catheters (PICCs), arterial catheters (e.g., hemodialysis access grafts and catheters, arterial catheters) and peritoneal catheters (e.g., peritoneal dialysis catheters, peritoneal catheters), venous catheters are placed for the administration of fluids (e.g., intravenous administration of fluids, drugs, or other substances). (e.g., medication) directly administered to the desired location, for access, dialysis, or nutrition (nasogastric tube, feeding tube, total parenteral nutrition tube, gastric tube); 5) catheters placed to perform medical or surgical procedures or devices [e.g., coronary angioplasty, peripheral angioplasty, angiography, arterial dilation and / or stent placement, balloon endoscopic surgery, balloon angioplasty, catheter-based ablation, balloon dilation catheters (esophagus, bile duct, trachea, bronchus, urethra, etc.)]; and 6) catheters placed to directly measure biological functions or values ​​(e.g., arterial or venous blood pressure, cardiac function, and intracranial pressure).

[0252] Commonly used catheters include Foley catheters for draining urine, ureteral catheters, central venous catheters (CVC, PICC, port) for administering drugs and fluids, and Swan-Ganz catheters primarily used for diagnostic purposes in the pulmonary artery. Representative examples of catheters are described in U.S. Patent Nos. 8,491,569, 8,469,989, 8,460,333, 8,359,082, 8,246,568, 8,285,362, 8,257,420, 8,317,713, 8,328,829, 8,262,653, 6,966,914, 5,989,213, 5,509,897, 4,772,268 and U.S. Publications 2012 / 0310158, 2012 / 0283641, 2012 / 0239032, and 2012 / 0253276, all of which are incorporated herein by reference in their entirety. In a defined embodiment of the invention, balloon catheters for deploying a stent or at the stent graft site may be optionally excluded to the extent that such exclusion is specifically stated or claimed.

[0253] Representative examples of endovascular catheters and balloon dilation catheters (including drug delivery catheters and balloon catheters) are found in U.S. Patent Nos. 5,180,366; 5,171,217; 5,049,132; 5,021,044; 6,592,568; 5,304,121; 5,295,962; 5,286,254; 5,254,089; and 5,112,305. 5,318,531, 5,336,178, 5,279,565, 5,364,356, 5,772,629, 5,810,767, 5,941,868, 5,362,309, 5,318,014, 5,315,998, 5,304,120, 5,282,785, 5,267,985, 5,087,24 4, 5,860,954, 5,843,033, 5,254,089, 5,681,281, 5,746,716, 6,544,221, 6,527,739, 6,605,056, 6,190,356, 5,279,546, 5236424, 5,226,888; 5,181,911, 4,824,436 The following patents are described in U.S. Patent Application Publications Nos. 4,636,195, 5,087,244, 6,623,452, 5,397,307, 4,636,195, 4,994,033, 5,362,309, and 6,623,444; U.S. Patent Application Publications Nos. 2002 / 0138036, 2002 / 0068869, and 2005 / 0186243; and PCT Publications Nos. WO 01 / 15771, WO 93 / 08866, WO 92 / 11890, WO 92 / 11895, WO 94 / 05361, WO 96 / 04955, and WO 96 / 22111, all of which are incorporated herein by reference in their entirety.

[0254] "Guidewire" refers to a medical device used to position another medical device (e.g., an intravenous catheter, endotracheal tube, central venous line, balloon catheter, or gastric feeding tube) or (e.g., during a breast biopsy) to position a tumor. Representative examples of guidewires are described in U.S. Patent Nos. 4,787,884, 5,911,734, 5,910,154, 6,676,682, 6,936,065, 6,964,673, and 7,691,123, and U.S. Publications 2006 / 0100694 and 2007 / 0027522, all of which are incorporated herein by reference in their entirety.

[0255] B.5.A. Conduits, tubes and their use B.5.A.1. Balloon Catheters and Their Use As described above, in various embodiments of the invention, the balloon catheter (and its associated medical device, such as a stent and / or guidewire) is provided with one or more ISMs having one or more of the sensors described herein. For example, Figure 18 The illustration depicts a balloon catheter with one or more integrated sensor modules (ISMs) containing various sensors positioned within or above the balloon catheter (and / or potential guidewire) to monitor in situ the real-time operation of the catheter, balloon inflation and deflation, the force exerted by the balloon on adjacent tissues or devices (e.g., stents), flow levels through and around the balloon, and acute and time-varying catheter performance. The sensor-containing ISMs may be positioned within the balloon catheter, within the wall of the balloon catheter, or on the outer surface of the balloon catheter. Although in some embodiments, such as Figure 18 The ISM shown can include contact sensors, pressure sensors, and positioning sensors, but a wide variety of other sensors can also be used within, on, or inside the balloon catheter, including, for example, fluid pressure sensors, accelerometers, vibration sensors, pulse sensors, fluid (e.g., blood) volume sensors, fluid (e.g., blood) flow sensors, fluid (e.g., blood) chemistry sensors, fluid (e.g., blood) metabolism sensors, mechanical stress sensors, and temperature sensors.

[0256] For example, a balloon catheter containing an ISM can be inserted via a guidewire into a narrowed artery, such as a coronary or peripheral artery. An ISM with a contact sensor capable of monitoring the balloon surface can be used to measure contact with the vessel wall during inflation, deployment, and deflation. Specifically, the balloon inflates, thereby dilating the artery (coronary or peripheral); an ISM with a pressure sensor can monitor the pressure within the balloon and the pressure exerted on the vessel wall. In a preferred embodiment, pressure is monitored, and if necessary, adjusted to prevent damage to the vessel wall due to excessive pressure. Pressure drop during balloon deflation can also be monitored to confirm that it is safe to remove the balloon catheter from the treated vascular injury. Similarly, an ISM containing a contact sensor can be used to monitor the contact between the balloon and the vessel wall during balloon deflation to confirm that it is safe to remove the balloon catheter from the treated vascular injury. An ISM containing a positioning sensor can be used in balloon catheters and guidewires to assist in balloon catheter placement (and, if necessary, stent placement) and for medical imaging. ISM positioning sensors contained within or on the balloon can be used to provide images of vascular anatomy, images of anatomy before and after inflation, confirmation of complete balloon inflation and deflation, confirmation of stent placement, and confirmation of complete stent expansion and deployment (if present).

[0257] In other embodiments, a balloon comprising an ISM with sensors can be used to assist in the placement of a balloon-expandable stent. For example, Figure 9A The illustration shows the locations of narrowing bifurcations that occur at multiple points within the blood vessel. Figure 9B The illustration depicts a stent with PTCA to open a lateral branch. In this configuration, (potentially “matched” or complementary) contact sensors on the ISM in both the stent and balloon can confirm accurate placement; ISM accelerometers on both the stent and balloon can confirm anatomical location and conformation; ISM positioning sensors on both the stent and balloon can monitor movement; ISM flow sensors on both the stent and balloon can confirm vessel patency; and ISM pressure / vessel wall sensors on both the stent and balloon can confirm full deployment and accurate vessel length. Overall, this sensing information creates a 3D image of the anatomy and physiology of the vessel and stent, significantly improving upon data obtained solely from angiography. This greatly increases the chances of accurate, safe, and effective deployment of multiple stents in complex vascular lesions.

[0258] It should be apparent from the disclosure provided herein that the balloon catheters containing ISMs and the associated medical devices containing ISM sensors described above can be used in the management of non-vascular diseases. Balloon catheters are used to open obstructed bodily channels and lumens in many other tissues, such as, but not limited to, sinuses, respiratory tracts, gastrointestinal tracts, biliary tracts, urinary tracts, and reproductive tracts. While the size, shape, and purpose of balloon catheters (and associated devices) can vary, the types, placement, and functions of various ISM sensors are similar to those described above for the vascular system. In summary, a wide variety of ISMs with multiple sensor types can be placed on and / or within the balloon catheters and associated devices (such as guidewires) described herein to provide “real-time” information and feedback to healthcare providers. Such balloons containing ISMs can be used by surgeons during surgical procedures to safely and effectively open obstructed bodily channels, confirm proper placement, verify anatomy, ensure effective dilation (and clearance of obstruction), monitor forces applied to surrounding tissues, follow complete balloon inflation and deflation, and detect strain / forces experienced during balloon procedures.

[0259] In this embodiment, the balloon catheter and associated devices (such as guidewires) provided herein may include one or more ISMs, each ISM having one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. These ISMs can be continuously monitored to provide “real-time” data, imaging, and functional changes during the procedure, and to better understand the balloon catheter’s exposure in clinical practice.

[0260] B.5.A.2. Central venous catheters and their use In other embodiments of the invention, a central venous catheter is provided having at least one ISM with one or more sensors disposed thereon. In short, a central venous catheter (also referred to as a “central line” or “CVC”) is a catheter typically placed in a large vein of the body [typically the superior vena cava (SVC) or inferior vena cava (IVC)] via a passage through a large vein in the neck (e.g., internal jugular vein), a large vein in the chest (e.g., subclavian or axillary vein), or a large vein in the groin (e.g., femoral vein) when reliable, long-term vascular access is required. However, a CVC can also be inserted peripherally (e.g., placed in the peripheral vascular system of a vein such as the arm and then advanced through the venous system until the tip reaches the SVC), and in this case is generally referred to as a “peripherally inserted central catheter” or “PICC”. A CVC is used to deliver drugs and / or fluids to a subject to obtain blood for testing and to measure pressure (typically at the distal tip of the catheter).

[0261] Central venous catheters (CVCs) can be either “non-tunneled” (i.e., fixed at the insertion site) or “tunneled” (i.e., extending from the insertion site to a separate exit site under the skin). A type of catheter similar to a “tunneled” catheter is a “port,” which, while similar, differs in that it remains entirely under the skin. In this case, medications and fluids can be injected directly into the port through the skin, or, for some types of ports, directly into a container contained within the port. The terms “central venous catheter” or “CVC” as used herein should be interpreted to include PICCs, ports, tunneled CVCs, and non-tunneled CVCs.

[0262] Common complications of the centerline include pneumothorax, centerline-associated bloodstream infection (CRBSI), thrombosis, hemorrhage, and hematoma or seroma formation at the insertion site.

[0263] Therefore, the central venous catheter of the present invention can be used having one or more intraluminal flow sensors (ISMs) having at least one of the sensors described herein. For example, in one embodiment, the central venous catheter of the present invention may have an ISM with one or more fluid flow sensors. In various embodiments, such an ISM may be located on the inner (intraluminal) surface of the catheter, on the outer (proximal or blood-contact) surface of the catheter, throughout the catheter, and / or (in a preferred embodiment) at the tip of the catheter. An ISM with a flow sensor can be used to measure the flow rate of fluid through the catheter lumen. If at least one ISM with a flow sensor is located proximally and at the tip, it is possible to determine whether and where an obstruction has occurred; for example, due to fibrin sheath formation, catheter stenosis, catheter thrombosis, or catheter kinking (e.g., a reduced intraluminal fluid flow rate will exist before stenosis and an increased intraluminal fluid flow rate will exist after stenosis; there will be no fluid flow before or after complete obstruction). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” an obstructed catheter.

[0264] In other embodiments, an ISM with a pressure sensor may be incorporated into the central venous catheter on the inner (intraluminal) wall, outer (proximal) wall, and / or body of the catheter itself. Such an ISM is capable of measuring pressure within the catheter wall or pressure applied to the catheter wall. Increased pressure may indicate stenosis, thrombosis, or kinking upstream of a narrowing or occlusion event, while decreased pressure will be seen downstream of a narrowing, and (very little or) no pressure will be seen downstream of an occlusion. The ability to measure pressure throughout the catheter (proximal and distal) allows for functional monitoring of the central venous catheter (during normal operation and during / after attempts to “reopen” an occluded catheter), and allows for the detection of events before complications occur.

[0265] In other embodiments, an ISM with a contact sensor is provided, which can be incorporated into a central venous catheter on the inner (intraluminal) wall, outer (proximal) wall, and / or body of the catheter itself to measure the contact between the intraluminal and proximal surfaces and the surrounding environment. Persistent foreign body contact on any surface can indicate fibrin sheath formation, thrombosis, biofilm formation, or infection; persistent contact at the tip can indicate that the catheter has been pushed against the vessel wall and needs to be repositioned. In yet another embodiment, an ISM incorporating a chemical sensor can be placed primarily on the proximal (blood-contact) surface to measure a wide range of metabolic parameters, including, for example: blood oxygen saturation; blood CO2 levels; blood pH; blood cholesterol; blood lipids (HDL, LDL); blood glucose; cardiac enzymes; liver enzymes; and renal function (BUN, creatinine, etc.).

[0266] In other embodiments, the ISM with positioning sensors may be placed within, on, or inside the catheter to allow imaging of the catheter and detection of changes and / or movement over time. Positioning sensors on the ISM within the CVC catheter are useful during catheter placement to ensure advancement into the SVC, rather than the right atrium of the heart; after placement, they can be used to determine whether the catheter has migrated proximally or distally (into the right atrium) over time.

[0267] In other embodiments, an ISM with chemical and / or temperature sensors may be incorporated into the CVC, making it blood-contact (on the luminal surface) and usable for monitoring temperature changes that may indicate the presence of an infection or developing infection.

[0268] In a particularly preferred embodiment, the ISM containing multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at the tip of the catheter, thus exposing both the intraluminal and proximal surfaces.

[0269] In summary, one or more ISMs containing a wide variety of sensors may be placed on and / or within the central venous catheter described herein to provide healthcare providers with “real-time” information and feedback (during placement, repositioning, or “reopening” procedures) to detect appropriate anatomical placement, vascular anatomy, alignment, forces applied to surrounding tissues, and changes encountered during placement and subsequent manipulation or repositioning procedures. For example, the central venous catheters (CVC, PICC, port) described herein may have one or more ISMs containing one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors.

[0270] B.5.A.3. Dialysis catheters and their use In other embodiments, a dedicated central venous catheter (CVC) may be used in hemodialysis procedures (typically when only short-term dialysis is required or as a bridge to a permanent dialysis procedure – see below). In short, a hemodialysis catheter (or alternatively – “acute dialysis catheter”) is a dedicated CVC placed in the central circulation for exchanging blood to and from a hemodialysis machine. Typically, the catheter has two lumens, one for venous flow and the other for arterial flow. The arterial lumen draws blood from the patient and delivers it to the hemodialysis machine, while the venous lumen (after the blood has been processed by the dialysis machine) returns blood to the patient. Typically, the flow rate of a dialysis catheter ranges between 200 and 500 ml per minute. If the patient requires long-term dialysis treatment, a “chronic” dialysis catheter may be used, which typically includes a cuff buried under the skin (and is believed to help act as a barrier against infection). Common complications of hemodialysis catheters include fibrin sheath formation, coagulation, biofilm formation, infection, and kinking. Therefore, the hemodialysis catheter of the present invention can be used, having one or more ISMs described herein. For example, in one embodiment, the hemodialysis catheter of the present invention may have one or more ISMs with blood flow sensors. In various embodiments, such ISMs may be located on the inner (intraluminal) surface of the catheter, on the outer (proximal) surface of the catheter, and within the wall of the catheter; in a preferred embodiment, the ISM containing the blood flow sensor is located at the tip of the catheter, such that it can measure the flow in both the arterial lumen and the venous lumen. They can be used to measure the fluid flow through the catheter. By comparing the readings of the ISM flow sensors at different locations in the hemodialysis catheter (i.e., the difference between proximal and distal readings), the degree of blockage (e.g., due to fibrin sheath formation, catheter stenosis, catheter thrombosis, or catheter kinking) can be determined (e.g., there will be reduced fluid / blood flow before narrowing and increased fluid / blood flow after narrowing; there will be no fluid / blood flow before or after complete blockage). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” a blocked catheter. In other embodiments, an ISM with a pressure sensor may be incorporated into the hemodialysis catheter on the inner (inner lumen) wall, outer (near lumen) wall, and / or body of the catheter itself. Such a sensor is capable of measuring pressure within the catheter wall or pressure applied to the catheter wall. Increased pressure may indicate narrowing, thrombosis, or kinking upstream of a stenosis or blockage event, while decreased pressure will be seen downstream of a narrowing, and (very little or) no pressure will be seen downstream of a blockage. The ability to measure pressure at different points within the catheter allows for functional monitoring of the hemodialysis catheter (during normal operation and during / after attempts to “reopen” a blocked catheter) and the ability to detect events before complications occur.

[0271] In other embodiments, an ISM with a contact sensor can be placed on the endoluminal and proximal surfaces of the hemodialysis catheter to measure the contact between the endoluminal and proximal surfaces and the surrounding environment. Persistent foreign body contact on either surface can indicate fibrin sheath formation, thrombosis, biofilm formation, or infection; persistent contact at the tip can indicate that the catheter has been pushed against the vessel wall and needs to be repositioned.

[0272] In yet another embodiment, the ISM with chemical sensors can be primarily placed on the proximal (blood-contact) surface to measure a wide range of metabolic parameters, including, for example: blood oxygen saturation; blood CO2 levels; blood pH; blood cholesterol; blood lipids (HDL, LDL); blood glucose; cardiac enzymes; liver enzymes; and renal function (BUN, creatinine, etc.). Many of these parameters are important in monitoring the need for, effectiveness, duration, and frequency of dialysis treatment and will greatly assist clinicians in managing patients with kidney disease; similarly, comparing values ​​in the arterial arm of the catheter, the venous arm of the catheter, and the systemic circulation will also provide useful clinical data.

[0273] In other embodiments, the ISM with positioning sensors may be placed on or within the hemodialysis catheter (e.g., on the surface of both the endoluminal and proximal lumen, and within the catheter material itself) to allow imaging of the catheter and detection of changes and / or movement over time. Positioning sensors are useful during catheter placement to ensure advancement into the appropriate anatomical position; after placement, they can be used to determine whether the catheter has migrated proximally or distally over time.

[0274] In other embodiments, an ISM with chemical and temperature sensors can be used to monitor temperature changes that may indicate the presence of existing infection, biofilm formation, or developing infection.

[0275] In a particularly preferred embodiment, the ISM containing multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at the tip of the catheter, such that it has both intraluminal and proximal surface exposures to the lumen of both the artery and vein leading to the dialysis catheter.

[0276] In summary, one or more ISMs equipped with a wide variety of sensors can be placed on and / or within the hemodialysis catheters described herein to provide healthcare providers with “real-time” information and feedback (or during placement or subsequent manipulation or “reopening” procedures), thereby detecting proper placement, vascular anatomy, alignment, forces applied to surrounding tissues, and changes encountered during placement and subsequent manipulation or repositioning procedures. For example, the hemodialysis catheters (acute and chronic) provided herein may have one or more ISMs equipped with contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors. These sensors can be continuously monitored to provide information on functional changes over time, “real-world” activity and patency, assess patient physiological function, and better manage dialysis patients.

[0277] B.5.A.4. Drainage catheters and their use In other embodiments of the invention, a drainage catheter is provided having one or more ISMs placed thereon. In short, drainage catheters are typically placed to drain fluids from body structures (e.g., surgical fluid, blood, peritoneal fluid, CSF, bile, synovial fluid, intestinal fluid, pus, abscess, pleural effusion, or urine, to name a few). In the context of urinary drainage, Foley catheters, designed to drain urine from the bladder, and ureteral catheters, designed to allow urine to drain from the kidneys, are commonly used in a wide variety of medical procedures. Drainage catheters are typically made of polymers such as silicone or rubber, but other materials (including biodegradable polymers) may also be used. In the case of Foley catheters, the catheter typically has two separate lumens, one of which allows drainage of urine (typically to a collection bag), and the other lumen has a valve that allows a balloon at the distal end of the catheter to inflate within the bladder after insertion to ensure that the catheter is not accidentally dislodged.

[0278] Common complications of drainage catheters include infection, catheter kinking, biofilm buildup (leading to potential obstruction and infection), balloon rupture (as well as overinflation or failure to inflate the balloon), and accumulation of obstructive foreign bodies on the inner surface of the lumen (urinary stones, gallstones, blood / clots, inflammatory tissue, fibrotic tissue, infected tissue).

[0279] Therefore, the drainage catheter of the present invention can be used, having one or more ISMs described herein. For example, in one embodiment, the drainage catheter of the present invention may have one or more ISMs with flow sensors. In various embodiments, such sensors may be located on the inner (luminal) surface of the catheter, on the proximal surface of the catheter, throughout the catheter, and / or concentrated at the end of the catheter. They can be used to measure the flow rate of fluid through the catheter. By comparing the readings of the ISMs containing flow sensors at different points in the drainage catheter, the degree of obstruction (e.g., due to the formation of clots, stones, or catheter kinks) can be determined (e.g., there will be reduced fluid flow before narrowing and increased fluid flow after narrowing; there will be no fluid flow before or after complete obstruction). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” an obstructed drainage catheter.

[0280] In other embodiments, an ISM with a pressure sensor may be incorporated into the drainage catheter on the inner (intraluminal) wall, outer (proximal) wall, and / or body of the catheter itself. Such a sensor is capable of measuring pressure within the catheter wall or pressure applied to the catheter wall. Increased pressure may indicate narrowing, thrombosis, foreign body obstruction, or kinking upstream of a narrowing or obstruction event, while decreased pressure will be seen downstream of a narrowing, and (very little or) no pressure will be seen downstream of an obstruction. The ability to measure pressure within the drainage catheter allows for functional monitoring of the catheter (during normal operation and during / after attempts to “reopen” an obstructed catheter) and the ability to detect events before complications occur.

[0281] In other embodiments, an ISM with a contact sensor can be placed on and throughout the drainage catheter to measure the contact between the intraluminal and proximal surfaces and the surrounding environment. Persistent foreign body contact on any surface can indicate fibrin sheath formation, thrombosis, stone formation, biofilm formation, or infection; persistent contact at the tip can indicate that the catheter has been pushed against the intraluminal wall (or adjacent tissue) and needs to be repositioned.

[0282] In other embodiments, an ISM with chemical sensors can be used to measure a wide variety of physiological parameters, including, for example: 1) urinary function (e.g., measurement of nitrates, sodium, potassium, calcium, and phosphate); 2) the presence of cells (e.g., white blood cells that may indicate infection and / or red blood cells that may indicate trauma, stones, infection, and / or malignancy); 3) protein / proteinuria (indicating diabetes, kidney or liver disease, hyperthyroidism, etc.); 4) glucose (for measuring diabetes); and a variety of other chemicals (e.g., ketones, bilirubin, urobilinogen, hemoglobin, creatinine, catecholamines, dopamine, cortisol, phenylalanine) and urine characteristics (e.g., specific gravity, osmolarity, pH, bacterial presence, and hCG); 5) the presence of bacteria (indicating infection in all cases).

[0283] In other embodiments, the ISM with positioning sensors may be placed throughout the drainage catheter (e.g., on the surface of both the endoluminal and proximal lumen, and within the catheter material itself) to allow imaging of the catheter and detection of changes and / or movement over time. Positioning sensors are useful during catheter placement to ensure (before balloon inflation, if present, in a Foley catheter) advancement to the appropriate anatomical position; after placement, they can be used to determine whether the catheter has migrated proximally or distally over time.

[0284] In other embodiments, an ISM with chemical and / or temperature sensors can be used to monitor temperature changes that may indicate the presence of infection, biofilm formation, or developing infection.

[0285] In a particularly preferred embodiment, the ISM containing multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at the tip of the drainage catheter, so that it has both intracavitary and proximal surface exposure.

[0286] In general, an ISM with one or more of the diverse sensors described herein can be used to detect, measure, and assess multiple factors related to the function of the kidney (and / or bladder) and any other organs (liver, pleural cavity, CSF, joints, etc.) in which a drainage catheter is placed. Such a drainage catheter can provide healthcare providers (or during placement or subsequent manipulation or “reopening” procedures) with “real-time” information and feedback to detect proper placement, anatomy, alignment, forces applied to surrounding tissues, and changes encountered during placement and subsequent manipulation or repositioning procedures. For example, the drainage catheters described herein may have one or more ISMs with one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, chemical sensors, metabolic sensors, mechanical stress sensors, and temperature sensors. These sensors can be continuously monitored to provide information on functional changes over time, “real-world” activity and patency, assess patient physiological function, and better manage patients with drainage catheters.

[0287] B.5.A.6. Vascular grafts and their use In other embodiments of the invention, the ISM can be placed on various vascular grafts. In short, a medical graft is a hollow tube or cylinder used to allow fluid (typically blood) to flow from one place to another. Medical grafts can be obtained from natural materials (e.g., saphenous vein or breast artery grafts), constructed from natural and / or artificial materials (e.g., bioengineered grafts or blood vessels), or constructed from entirely synthetic materials (e.g., vascular grafts composed of polymers such as polytetrafluoroethylene or “PTFE” or polyester). Representative examples of medical grafts are disclosed in U.S. Patent Nos. 5,556,426, 5,628,786, 5,641,373, 6,863,686, and 8,062,354.

[0288] In one embodiment of the invention, one or more ISMs comprising multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) are located at the distal end of the bypass graft (made of natural material), such that it has an exposed intraluminal surface. For example, during coronary artery bypass grafting (or “CABG” procedure), an artery or vein from another part of the body may be grafted onto the coronary artery to bypass atherosclerotic narrowing and improve blood supply to the myocardium (e.g., where the saphenous vein is used for coronary artery bypass and the mammary artery is used for coronary artery bypass).

[0289] In other embodiments of the invention, synthetic vascular grafts can be used to bypass obstructions (e.g., synthetic vascular bypass grafts can be used to bypass obstructions in the lower extremities). Therefore, grafts having the ISM of the present invention have a wide range of applications. For example, in one embodiment, the graft of the present invention may have an ISM with one or more blood flow sensors. In various embodiments, such an ISM including blood flow sensors may be located on the inner (intraluminal) surface of the graft, on the outer (proximal) surface of the graft, throughout the graft (e.g., woven into fabric of the synthetic graft, or incorporated into the metal of a “supporting” graft), and / or concentrated at the ends of the graft (i.e., proximal and distal vascular anastomoses). They can be used to measure blood flow through the graft. By comparing sensor readings from one part of the graft with those from another part, the determination of partial narrowing (and the degree of narrowing) can be determined (e.g., reduced blood flow before narrowing or stenosis, and increased blood flow after narrowing). If the vascular graft is completely blocked, there will be no flow through the graft (before or after the blockage). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” a blocked catheter.

[0290] In other embodiments, an ISM with a pressure sensor may be incorporated into the graft [e.g., on the outer (near lumen) wall, inner (intraluminal) wall, and / or within the graft itself (as described above for flow sensors)]. Such a sensor is capable of measuring pressure within or against the vessel wall. Increased pressure may indicate stenosis, thrombosis, or kinking upstream of an obstruction event, while decreased pressure will be seen downstream of the stenosis, and (very little or) no pressure will be seen downstream of the obstruction. The ability to measure pressure throughout the vessel allows for functional monitoring of the graft (during normal operation and during / after attempts to “reopen” an obstructed graft) and the ability to detect events before complications occur.

[0291] In other embodiments, an ISM with contact sensors can be placed on and throughout the graft to measure the contact (seal integrity) between the bypass graft and its attached vascular anastomosis, in order to identify leakage or anastomosis failure (during and after surgical placement). Contact sensors on the graft cavity surface can also detect the presence of unwanted accumulated cavity surface material (such as restenosis tissue, fibrin, or biofilm) and alert clinicians to potential problems.

[0292] In another embodiment, the ISM with chemical sensors may also be placed on and throughout the graft to measure a wide variety of important metabolic parameters, including, for example: blood oxygen content; blood CO2 content; blood pH; blood cholesterol; blood lipids (HDL, LDL); blood glucose; cardiac enzymes; liver enzymes; and kidney function (BUN, creatinine, etc.).

[0293] In other embodiments, the ISM may be provided with a sufficient number of positioning sensors (e.g., on both the intracavitary and proximal surfaces, and within the graft material itself) to allow imaging of the graft and detection of changes over time (such as bending or kinking) and / or movement.

[0294] In a particularly preferred embodiment, the ISM containing multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at the two anastomoses of the bypass graft, thus exposing its intracavitary surface.

[0295] In general, intravascular microscopy (ISM) within vascular grafts can be used to detect, measure, and assess many factors related to cardiac function. For example, blood flow detectors, blood pressure detectors, and blood volume detectors (e.g., for measuring blood volume per unit time) can be placed within the vascular graft (on the inner side) and on other parts of the graft to measure systolic and diastolic blood pressure, cardiac output, ejection fraction, cardiac index, and systemic vascular resistance.

[0296] In other embodiments of the invention, vascular grafts (synthetic grafts and prosthetic grafts, such as arteriovenous fistulas) can be used in hemodialysis procedures. In short, a hemodialysis access graft is a vascular graft implanted by a vascular surgeon as an artificial, high-flow intercalation graft (or direct anastomosis) between an artery and a vein (typically in the forearm or thigh) to provide a permanent pathway for hemodialysis (prosthetic arteries and veins tend to collapse and close after repeated instrumentation). Once mature and suitable for use, the hemodialysis access graft (or AV fistula) serves as a permanent site for inserting another catheter for exchanging blood to and from the hemodialysis machine. Typically, this catheter has two lumens, one for venous flow and the other for arterial flow (as described above in the preceding sections). Common complications of hemodialysis access grafts include coagulation, stenosis (most commonly occurring at graft-vein anastomoses but occasionally at arteriovenous anastomoses), infection, and kinking. Therefore, the hemodialysis access graft of the present invention can be used, having one or more ISMs with one or more sensors described herein. For example, in one embodiment, the hemodialysis access graft of the present invention may have an ISM with one or more blood flow sensors. In various embodiments, such an ISM with blood flow sensors may be located on the inner (intraluminal) surface of the access graft, within the wall of the access graft (e.g., woven into the fabric of the synthetic graft, or incorporated into the metal of the “supporting” graft), and / or concentrated at various locations (e.g., end-anastomoses of the access graft). The ISM with blood flow sensors can be used to measure the blood flow through the hemodialysis access graft. By comparing the readings of the ISM flow sensors at various locations in the graft (e.g., arterial and venous anastomoses), the determination of partial narrowing (and the degree of narrowing) can be determined (e.g., there will be reduced blood flow before narrowing or stenosis, and increased blood flow after narrowing). If the access graft is completely blocked, there will be no flow through the graft (before or after blockage). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” a blocked dialysis catheter (a common interventional procedure).

[0297] In other embodiments, an ISM with a pressure sensor may be incorporated into the dialysis access graft [e.g., on the outer (near lumen) wall, inner (intraluminal) wall, or within the body of the access graft itself as described above]. Such a sensor is capable of measuring pressure within or against the access graft wall. Increased pressure within the graft can indicate stenosis upstream of an obstruction event (typically at graft-venous anastomoses, but occasionally at arterial-graft anastomoses), thrombosis, or kinking, while decreased pressure will be seen downstream of the stenosis, and (very little or) no pressure will be seen downstream of the obstruction. The ability to measure pressure throughout the vessel allows for functional monitoring of the graft (during normal operation and during / after attempts to “reopen” an obstructed graft) and the ability to detect events before clinical complications occur.

[0298] In other embodiments, an ISM with a contact sensor can be placed on the end of a hemodialysis access graft to measure the contact (seal integrity) between the access graft and its attached vessel (i.e., the arterial-venous anastomosis) to identify leakage or anastomosis failure (during and after surgical placement). A contact sensor in the ISM on the luminal surface of the graft can also detect the presence of surface material (such as restenosis tissue, fibrin (clots), or biofilms) and alert clinicians to potential problems. In yet another example, an ISM with a chemical sensor can also be placed on and / or within the access graft, such that the sensor has luminal exposure to measure a wide variety of metabolic parameters, including, for example: blood oxygen saturation; blood CO2 levels; blood pH; blood cholesterol; blood lipids (HDL, LDL); blood glucose; cardiac enzymes; liver enzymes; and renal function (BUN, creatinine, etc.); parameters that are important in the clinical management of patients with advanced renal disease.

[0299] In other embodiments, the ISM with positioning sensors may be placed throughout the hemodialysis access graft (e.g., on the surface of both the intraluminal and proximal surfaces, and within the access graft material itself) to allow imaging of the access graft and detection of changes (bending, kinking) and / or movement over time.

[0300] In general, one or more ISMs having the wide variety of sensors described herein can also be used to detect, measure, and assess multiple factors related to cardiac function. For example, flow rate detectors, blood pressure detectors, and (e.g., for measuring blood volume per unit time) blood volume detectors can be placed within the access graft (on the luminal side) and on other parts of the access graft to measure systolic and diastolic blood pressure and estimate systemic vascular resistance. In particularly preferred embodiments, an ISM having one or more flow rate detectors, blood pressure detectors, and blood volume detectors can also be used to calculate cardiac output, ejection fraction, and cardiac index (key clinical measurements valuable in monitoring patients with cardiac impairment, which is common in many patients with kidney disease). For example, an ISM containing a high-fidelity pressure transducer can be located above, in, or within the hemodialysis access graft to measure the timing and pressure of the stroke. Such measurements can be used to assess stroke volume and systemic vascular resistance and provide continuous cardiac output and heart rate monitoring. In other embodiments, chemical and temperature sensors can be used to monitor changes in temperature and / or the presence of infection or developing infection. With the increasing reliance on reusable instruments for grafts, the incidence of infection is quite high, and monitoring for infection before the onset of clinical symptoms is of great value for patient management.

[0301] In a particularly preferred embodiment, the ISM containing multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at one or both ends of the hemodialysis access catheter (i.e., at the arteriovenous anastomosis), such that it has an exposed luminal surface.

[0302] In summary, ISMs with a wide variety of sensors can be placed on and / or within the hemodialysis access grafts described herein to provide healthcare providers (or surgeons during surgical procedures for implanting hemodialysis access grafts, or interventionalists performing procedures to open obstructed hemodialysis access grafts) with “real-time” information and feedback, detecting proper placement, vascular anatomy, alignment, cardiac output, renal function, infection, and any changes encountered before, during, or after the interventional procedure. For example, the hemodialysis access grafts described herein may have one or more ISMs with one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. These sensors can be continuously monitored to provide information on functional changes over time, “real-world” activity and healing, assess patient activity, and better understand the conditions of real-world exposure of the hemodialysis access graft.

[0303] B.5.A.7. Other medical tubes and their use In other embodiments, a wide variety of medical tubes are provided, which may have an ISM with one or more sensors. Representative examples of medical tubes include periosteal tubes, endotracheal tubes, tracheostomy tubes, nasogastric tubes, gastric tubes, feeding tubes, colostomy tubes, rectal tubes, and chest tubes.

[0304] For example, in one embodiment, one or more ISMs having one or more sensors may be placed on an endotracheal tube. In short, an endotracheal tube is a catheter inserted into the trachea for the primary purpose of establishing and maintaining an open airway. The tube may be transoral (inserted into the mouth), transnasal (inserted into the nose), or via a tracheostomy (e.g., inserted into the trachea through a hole or incision).

[0305] In other embodiments, the tube having one or more ISMs with one or more sensors can be a drainage tube, such as a chest tube. In short, a chest tube (also known as a "thoracic drainage tube," thoracic duct, tubular thoracostomy tube, and intercostal drainage tube) is a flexible tube that can be inserted through the chest wall and into the pleural cavity or mediastinum. Such tubes can be used to remove air (e.g., pneumothorax), fluids (e.g., pleural effusion, blood, chyle), and infectious materials (e.g., empyema, pus).

[0306] Chest tubes come in a range of sizes (e.g., 6Fr to 40Fr), may have multiple drainage windows, and optionally, may be marked for distance (or length) of the tube, and may include radiopaque markers. They are available in a variety of configurations (e.g., right-angle, cannula, flared, and conical) and may be coated to prevent thrombosis or blockage. Such tubes can be made from a variety of materials, including polyvinyl chloride (“PVC”), silicone, latex, and polyurethane.

[0307] Tubes (e.g., periosteal tubes, endotracheal tubes, tracheostomy tubes, nasogastric tubes, gastric tubes, feeding tubes, colostomy tubes, rectal tubes, and chest tubes) can suffer from a variety of complications, such as improper placement, damage to surrounding tissues (or infiltration into surrounding tissues), narrowing, obstruction, migration / displacement, and infection. For example, endotracheal tubes have been found to cause numerous problems, including inspiration, improper placement, airway obstruction, esophageal or tracheal perforation, sore throat, pneumonia, narrowing, as well as arrhythmias, hypertension, increased intracranial pressure, increased intraocular pressure, bronchospasm, laryngospasm, vocal cord injury, retropharyngeal abscess, nerve injury, and fistula.

[0308] Therefore, the tubes of the present invention can be used having one or more ISMs with flow sensors as described herein. For example, in one embodiment, the chest tubes and endotracheal tubes of the present invention are provided with ISMs having one or more flow sensors. In various embodiments, such sensors may be located on the inner (intraluminal) surface of the tube, on the outer (proximal) surface of the tube, inside the tube, and / or concentrated at the ends of the tube. They can be used to measure the flow rate of fluids through the tube, such as air flow (endotracheal tubes in pneumothorax, chest tubes; note that other tubes as described above may have other bodily fluids passing through them). By comparing the readings of the sensors throughout the tube, the determination of partial narrowing (and the degree of narrowing) can be determined (e.g., there will be a reduced air flow rate before narrowing or stenosis, and an increased air flow rate after narrowing). If the tube is completely blocked, there will be no flow through the lumen (before or after the blockage). The ability to monitor flow rate will be valuable during normal operation and during / after procedural attempts to “reopen” a blocked tube.

[0309] In other embodiments, the ISM incorporating a pressure sensor may be integrated into the tube [e.g., on the outer (near lumen) wall, inner (intraluminal) wall, and / or within the body of the tube itself]. Such a sensor is capable of measuring pressure within or against the tube wall. Increased pressure (e.g., ventilation pressure in the endotracheal tube) may indicate narrowing, blockage, or kinking upstream of an obstruction event, while decreased pressure will be seen downstream of narrowing, and (very little or) no pressure will be seen downstream of blockage. Monitoring the pressure in the inflatable cuff of the endotracheal tube ensures adequate inflation; no pressure is too high to cause damage to the mucosa of the surrounding trachea, but the pressure is not too low to allow fluid to pass through the cuff and enable aspiration. The ability to measure pressure at different locations within the tube allows for functional monitoring of the tube (during normal operation and during / after attempts to “reopen” an obstructed tube) and the ability to detect events before clinical complications occur.

[0310] In other embodiments, an ISM incorporating a contact sensor is placed on or within the tube to measure the contact (seal integrity) between the tube and the tissue where it is placed, in order to identify leakage, rupture, or migration of the tube (during and after surgical placement). The ISM contact sensor, with access to the luminal surface of the tube, can detect the presence of fibrous / inflammatory tissue or biofilm formation and alert clinicians to potential problems. Monitoring contact on the surface of the inflatable cuff of the endotracheal tube ensures proper inflation; creates a sufficient seal between the cuff and the tracheal mucosa to prevent fluid from passing through the cuff and allow aspiration to occur.

[0311] In other embodiments, the ISM with chemical sensors is located above or within the medical tube for the purpose of measuring a wide variety of physiological parameters, including, for example: 1) histochemistry (e.g., measurements of nitrates, sodium, potassium, calcium, and phosphate); 2) the presence of cells (e.g., white blood cells that may indicate infection and / or red blood cells that may indicate trauma, erosion / ulceration, or device penetration into blood vessels); 3) proteins (serum); and 4) the presence of glucone, bilirubin, urobilinogen, hemoglobin, osmolarity, pH, bacteria, and tumor markers.

[0312] In other embodiments, the ISM containing the positioning sensor is located above or within the medical tube (e.g., on the surface of both the endoluminal and proximal surfaces, and within the tube material itself) to allow imaging of the tube and detection of changes and / or movement of the tube over time. For example, misplacement of an endotracheal tube (often unintentional placement in the esophagus) is a very dangerous complication; 50% of misplacements in the emergency room result in death. A positioning sensor capable of better (“real-time”) defining the anatomical location and placement of the medical tube would be of greater utility. Many other tubes (e.g., proper chest tube placement in a pleural region requiring decompression / drainage rather than in adjacent tissues (lung, heart, pericardium)) would also benefit. After insertion, many tubes can move from their initial placement sites (e.g., tympanostomy tubes often dislodge, endotracheal tubes can migrate into one of the bronchi to produce uneven ventilation, and chest tubes can move from the desired drainage area) and would benefit from the ability to monitor their movement and current position.

[0313] In other embodiments, the ISM is equipped with a chemical sensor and / or a temperature sensor, which can be used to monitor changes in temperature and / or the presence of an infected or developing infection.

[0314] In general, a wide variety of tubes are provided with an ISM having one or more sensors as described herein, which can be used to detect, measure, and evaluate multiple factors related to the function of many implanted tubes. In a particularly preferred embodiment, the ISM comprising multiple sensors (flow sensor, positioning sensor, accelerometer, pressure sensor, contact sensor, chemical sensor, temperature sensor) is located at the distal end of the medical tube (i.e., at the tissue contact end), such that it has an exposed luminal surface.

[0315] In summary, one or more ISMs incorporating a wide variety of sensors may be placed on and / or within the medical tubes described herein to provide “real-time” information and feedback to healthcare providers (or physicians during insertion or follow-up procedures) to detect proper placement, anatomy, alignment, forces exerted on surrounding tissues (as well as entry points into non-target tissues, damage to non-target tissues), integrity, flow rate, surface condition, patency, and movement / migration of the implanted tube, as well as to detect and monitor the properties of the fluid flowing through them. For example, tubes provided herein (e.g., tympanostomy tubes, endotracheal tubes, tracheostomy tubes, nasogastric tubes, gastric tubes, feeding tubes, colostomy tubes, rectal tubes, and chest tubes) may have one or more ISMs incorporating one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, chemical sensors, metabolic sensors, mechanical stress sensors, and temperature sensors.

[0316] These sensors can be monitored continuously or intermittently to provide information on functional changes over time, “real-world” function and healing, assess patient response, and better understand the conditions of tube exposure in the real world.

[0317] As will be apparent from the disclosure provided herein, the ISM described and claimed herein may include a variety of different sensors located at different locations within the ISM. Additionally, in various embodiments of the invention, one or more sensors may be placed separately from the ISM (but still optionally, may be capable of communicating with and being controlled by the ISM). A representative example of a sensor placed on a medical tube is provided in U.S. Provisional No. 62 / 017086, which is hereby incorporated herein by reference in its entirety.

[0318] B.6. Implants In one embodiment of the invention, an implant having one or more ISMs as described herein is provided. In short, as used herein, the term "implant" refers to an artificial or synthetic prosthesis that has been implanted in or can be implanted in the body. Implants are commonly used to augment or replace structures within the body and have been used in a wide variety of aesthetic applications, including, for example, implants for the face (e.g., lip, chin, nose, nasolabial folds, and cheekbones), the penis, and body contouring (e.g., breast, chest, calf, buttock, abdomen, and biceps / triceps).

[0319] As used herein, the term "peripheral implant" refers to an artificial or synthetic implant or material placed within an implant pouch into which the aesthetic implant will ultimately be inserted. When the aesthetic implant is inserted into the body, the "pouch," or the anatomical space created by the surgery, is first anatomically oriented to the tissue that will receive the aesthetic implant. The "peripheral implant" is typically a gel, adhesion barrier, hemostatic agent, glue, and / or adhesive placed within the implant pouch such that it is positioned between the aesthetic implant and the host tissue (for the same purpose, a pouch or other device may be placed around the aesthetic implant). Generally, the function of the "peripheral implant" is to prevent or minimize (at least initially) contact between the aesthetic implant and the host tissue in an attempt to reduce scar formation and capsular contraction.

[0320] Implants can be made of a wide variety of materials, but using breast implants as an example, they typically consist of an elastic outer surface or "shell" and an internal "filler." Regarding the shell, silicone is the most commonly used elastomer, which can be smooth or textured. As for the filler, most implants are filled with silicone or saline (although other compositions have been proposed, including, for example, peanut oil, sunflower oil, soybean oil, and polypropylene cord).

[0321] In various embodiments, the implant may include more than one type of internal filler (e.g., in different compartments) and may be coated (with polymers, gels, pharmaceuticals) and / or textured on its outer shell, or may be pouched to reduce the incidence of capsular contracture. Additionally, implants may be provided in different sizes and shapes, and even customized to specific anatomical requirements. In other embodiments, one implant may be delivered to one location in the breast (e.g., subfascial), while another implant is delivered to a different location (e.g., subglandular).

[0322] Representative examples of implants are described in U.S. Patent Nos. 4,995,882, 6,251,137, 6,464,726, 8,420,077 and U.S. Publications 2006 / 0136056, 2009 / 0099656, 2011 / 0184277, and 2014 / 0088700. Representative examples of implant delivery devices include U.S. Patent Nos. 8,550,090 and U.S. Publications 2014 / 0074235 and 2014 / 0074236.

[0323] The implants and medical devices provided herein are preferably sterile, pyrogen-free, and / or suitable for use in humans and / or implantation in humans. However, in some embodiments of the invention, the medical devices and / or kits may be prepared in a non-sterile environment (or even customized or “printed” for individual subjects) and sterilized at a later point in time.

[0324] In one embodiment of the invention, the implant is provided with such... Figure 19 An ISM with one or more sensors is shown. For example, an ISM with one or more positioning sensors and / or accelerometers may be placed within the “filler” of the implant, or on or within the “shell” of the implant. Such sensors are capable of providing: a) images of the implant (or “real-time” imaging of the implant); b) assistance during implant placement, and confirmation after implantation in the correct anatomical position (e.g., by the imaging methods described above, or by comparison with external markers); and c) confirmation of full expansion (i.e., no wrinkling or folding in situ). Additionally, such sensors are useful in confirming that the implant is functioning as intended [e.g., a) confirmation that it has not moved or migrated; b) confirmation that scar formation or cyst contraction has not yet begun; c) confirmation that the integrity of the implant is intact (i.e., no leakage), or by identifying leakage from the implant surface; and d) confirmation that the implant is not wrinkled or folded]. Sensors can also be used to ensure that acute complications do not occur (e.g., hematoma, seroma, granuloma, abscess, or other lumps in the tissue surrounding the implant due to external pressure applied to the implant itself).

[0325] In other embodiments, the implant is provided with one or more ISMs having contact sensors and / or pressure sensors. As described above, the contact sensors and / or pressure sensors may be placed within the “filler” of the implant, or on or within the “shell” of the implant. Such sensors are capable of providing: a) images of the implant (or “real-time” imaging of the implant); b) assistance during implant placement, and confirmation after implantation in the correct anatomical position (e.g., by the imaging method described above, or by comparison with external markers); and c) confirmation of full expansion (i.e., no wrinkling or folding in situ). Additionally, such sensors are useful in confirming that the implant is functioning as intended [e.g., a) confirmation that it has not moved or migrated; b) confirmation that scar formation or capsule contraction has not yet begun; and c) confirmation that the integrity of the implant is intact (i.e., no leakage), or by determining leakage from the implant surface; and d) confirmation that the implant is not wrinkled or folded]. The sensor can also be used to ensure that acute complications do not occur (e.g., hematoma, seroma, granuloma, abscess, or other lumps in the tissue surrounding the implant caused by external pressure applied to the implant itself).

[0326] In other embodiments, the implant is provided with one or more ISMs having one or more accelerometers. Such accelerometers can be used to: a) determine the durability of the implant based on "real-world" conditions; b) determine whether different implants are better for certain patients (based on activity levels, impact forces, forces, weight, etc.); and c) assist manufacturers in designing new implants, improving products, and collecting clinical data. Furthermore, it will allow for the evaluation of the performance of different devices under similar conditions, and the ability for patients to monitor their progress at home.

[0327] In other embodiments, the implant is provided with one or more ISMs having one or more temperature sensors and / or chemical or metabolic sensors. Such sensors can be used to detect the presence of infection, seroma, hematoma, and inflammation, and allow for rapid or preemptive intervention (e.g., administration of antibiotics before full-blown infection occurs, drainage of subclinical hematoma or seroma, or measures to reduce inflammation in an effort to reduce the chance of capsule contraction).

[0328] It will be apparent to those skilled in the art that an ISM containing the same sensor can be incorporated into surrounding implants for the same purposes as described above.

[0329] As will be apparent from the disclosures provided herein, a wide variety of other sensors may also be used within the ISM, including, for example, pulse pressure sensors, heart rate sensors, glucose sensors, or sensors for detecting tumor markers (particularly breast cancer).

[0330] As will be apparent from the disclosure provided herein, the ISM described and claimed herein may contain various different sensors at different locations within the ISM. Additionally, in various embodiments of the invention, one or more sensors may be placed separately from the ISM (but still optionally, may be capable of communicating with and being controlled by the ISM). Representative examples of sensors placed on an implant are provided in U.S. Provisional No. 62 / 017099, which is hereby incorporated herein by reference in its entirety.

[0331] B.7. Spinal implants In one embodiment of the invention, a spinal implant having one or more ISMs as described herein is provided. Briefly, the terms “spinal device and / or spinal implant” as used herein refer to a wide variety of devices (typically hardware) and implants (typically biomaterials such as bone grafts and bone grafts) that (typically in interventional or surgical procedures) may be implanted into, around, or in place of a subject’s spinal portion, and may be used to facilitate vertebral fracture repair, vertebral fusion, correction of degenerative disc disease (DDD), spinal stabilization, and correction of deformities due to disease and / or injury. Spinal devices / implants are typically permanent, but in some cases may be temporary. Representative examples of spinal devices and implants include, for example, spinal cages (e.g., U.S. Patent Nos. 5,425,772, 6,247,847, 6,428,575, 6,746,484, 7,722,674, 7,744,599, 7,988,713, 8,172,905 and U.S. Patent Application Nos. 2004 / 0082953, 2011 / 0015742, 2012 / 0046750, 2013 / 0082953, 2011 / 0015742, 2012 / 0046750, 2013 / 0082953, 2011 / 0015742, 2012 / 0046750, 2013 / 0082953, 2012 / 0082953 ...2 / 0082953, 2012 / 0082953, 201 53894 and 2013 / 0158669: Pedicle screws and associated devices (e.g., U.S. Patent Nos. 7,678,137, 8,361,121 and U.S. Patent Application Nos. 2005 / 0187548, 2006 / 0195086, 2008 / 0154309 and 2009 / 0287255); Artificial intervertebral discs and associated components (e.g., U.S. Patent Nos. 5,676,701, 8,226,723 and U.S. Patent Application Nos. 2005 / 0187548, 2006 / 0195086, 2008 / 0154309 and 2009 / 0287255). Application numbers 2006 / 0293753, 2007 / 0088439, 2007 / 0179611, 2008 / 0133014, 2011 / 0054617, and 2012 / 0232662; spindles and associated components (e.g., U.S. Patent Applications 2003 / 0050640, 2004 / 0015166, 2007 / 0118122, 2008 / 0306528, and 2009 / 01772). 32, 2011 / 0245875, 2013 / 0211455, and 2013 / 0231703; spinal plates and their components (e.g., U.S. Patent Nos. 8,246,664, 8,262,594, 8,343,223 and U.S. Patent Application Nos. 2009 / 0210008, 2010 / 0069968, and 2013 / 0006367); and vertebroplasty / kyphoplasty balloons and bone grafts (see, for example, US 2007 / 0100449, US 2009 / 0299373); all of these patents are incorporated herein by reference in their entirety.

[0332] Spinal devices / implants can be made of a wide variety of materials, including, for example, metals such as titanium, titanium alloys and / or stainless steel, although other materials may also be used, including polymers (e.g., polymethyl methacrylate or "PMMA", polyetheretherketone or "PEEK" for cervical cages and anterior thoracic and lumbar implants, and bone graft materials that may be allogeneic, xenogeneic or synthetic); growth factors (e.g., bone morphogenetic proteins); and non-polymer materials such as silicon nitride.

[0333] "Spine implant surgical equipment" or "spine implant delivery equipment" refers to devices that can be used to introduce a spinal implant into a patient, and / or tools and equipment that can be used for surgical procedures performed on the spine. Representative examples include guidewires, cannulas, bone tunnel catheters, electrothermal catheters, endoscopes, microsurgical instruments, surgical instruments, kyphoplasty balloons, and bone graft injection devices (to name a few).

[0334] The medical devices, implants, and kits provided herein are preferably sterile, pyrogen-free, and / or suitable for human use and / or implantation. However, in some embodiments of the invention, the medical devices and / or kits may be prepared in a non-sterile environment (or even customized or “printed” for individual subjects) and sterilized at a later point in time.

[0335] B.7.A. Procedures for Vertebroplasty and Kyphosis Correction In various aspects of this invention, spinal devices / implants and associated medical devices are configured with an ISM suitable for use in a wide range of vertebroplasty and kyphoplasty procedures. In short, vertebral compression fractures can be caused by sudden collapse of the vertebral body and result in a rapid onset of back pain, numbness, tingling, weakness, spinal cord compression, and cauda equina syndrome (e.g., extremity weakness, paraplegia, urinary retention, urinary / fecal incontinence, sexual dysfunction, sciatica, diminished ankle reflexes, and saddle anesthesia). It is commonly found in patients with osteoporosis but can also occur due to other causes (e.g., trauma, lytic lesions from metastatic or primary tumors, infection, and osteogenesis imperfecta).

[0336] In vertebroplasty procedures, a bone-bonding agent (e.g., polymethyl methacrylate or "PMMA") is percutaneously injected into the fractured vertebral body to restore normal vertebral height and anatomy, thereby reducing pain and symptoms associated with compression fractures. Using a percutaneous approach or a small surgical incision, a hole is created in the vertebral body wall through a specialized bone tunneling catheter, and a delivery catheter is then introduced into the vertebral body at the fracture site. The bone-bonding agent is then injected into the cancellous bone of the collapsed vertebral body until sufficient PMMA material has been injected to restore the vertebral body to its normal height and anatomy (the bond hardens and supports the broken bone).

[0337] Vertebral kyphoplasty is a special form of vertebroplasty. In vertebroplasty, a balloon is first inserted into the cancellous bone of a vertebral compression fracture and then inflated to restore normal vertebral height and spinal shape (kyphosis) and create a cavity. The balloon is then removed, and PMMA is injected into the cavity created by the balloon and allowed to harden in place to form a solid support structure within the fractured vertebra. Many medical devices can be used to perform vertebroplasty, including insertion needles, syringes for bone bonding agents, bone needles, guidewires, bone tunnel catheters, balloon insertion catheters, and vertebroplasty balloon catheters.

[0338] In various embodiments of the invention, the sensor-integrated ISM may be placed in some or all of the spinal implants and associated devices used for vertebroplasty and / or kyphoplasty.

[0339] For example, such as Figures 20A-20E As shown, the pores are created in the vertebral body via bone tunneling ducts. Figure 20A ISM was introduced (); Figure 20B ); followed by conveying equipment ( Figure 20C This allows the bone-setting agent to be injected directly into the collapsed bone. Compression fractures are treated by injecting the bone-setting agent into the vertebral body (e.g., Figure 20D and Figure 20E (As shown) to correct and support, in order to restore the normal height of the vertebrae.

[0340] Similarly, such as Figure 21As shown, one or more intramural septa (ISMs) can be placed on or within the kyphoplasty balloon. The ISMs may have pressure sensors to monitor the pressure exerted on the cancellous bone by the kyphoplasty balloon (especially during inflation) and optimize inflation pressure (to prevent overinflation leading to potential tissue damage) and deflation pressure (to ensure the balloon is fully deflated before attempting to remove the device). ISMs containing contact sensors can also be placed on or within the kyphoplasty balloon to monitor contact between the balloon and the cancellous bone of the vertebral body. Similarly, ISMs containing positioning sensors / position markers can be placed on or within the kyphoplasty balloon to assist in the accurate placement of the insertion device, balloon, and bone graft into the compression fracture. Positioning sensors and position markers can also be used to monitor vertebral body expansion (e.g., by monitoring the position of the balloon walls as the balloon is gradually inflated) for more precise expansion; this allows for a more accurate match to existing anatomical defects. "Visualization" via ISM sensors present on the balloon facilitates accurate placement, optimal expansion, more precise measurements of defect correction, and safe deflation and extraction; all of which are performed "in real time" during the procedure. In a preferred embodiment, one or more ISMs contained on or within the kyphoplasty balloon include a number of sensors, including positioning sensors, position markers, accelerometers, pressure sensors, and contact sensors.

[0341] An ISM with a sensor can have a variety of additional uses, including assisting in the identification of vertebral anatomy (e.g., measuring the exact vertebral height and appropriate kyphosis recovered during kyphoplasty), preventing accidental placement of kyphoplasty instruments into surrounding tissues (spinal cord, spinal nerves, etc.), confirming complete (or optimal) balloon inflation and deflation, confirming the recovery of vertebral height and kyphosis after kyphoplasty, and imaging the cavity where the bone graft will be injected to more accurately match the volume to be injected and prevent overfilling and / or leakage of the bone graft. In various embodiments of the invention, the ISM or a passive sensor may be added to the bone graft along with the ISM and may be used to inquire about various aspects of the procedure (as described above) as well as the ultimate success and maintenance of the procedure (see [link to invention]). Figures 20A-20E and Figure 21 An ISM containing an accelerometer can be placed within the bone bonding agent to detect acceleration, vibration, impact, tilting, and rotation of the bonding agent within the vertebral body. Such a sensor can be used to create 2D and 3D imaging data showing the size and shape of the filled voids, movement and / or dissolution of the bone bonding agent, and potential complications such as bonding agent leakage or impaction into the spinal cord and / or around spinal nerves. In a preferred embodiment, image data can be collected over time to visually represent changes detected by the sensor (e.g., a “moving image”).

[0342] In a preferred embodiment, one or more ISMs contained within the bone bonding agent include a number of sensors, including positioning sensors, position markers, accelerometers, pressure sensors, and contact sensors, to monitor the development of spinal anatomy, function, and side effects.

[0343] Optionally, an ISM containing a chemical sensor and placed within the bone bonding agent can be used to monitor pH, calcium content, and other parameters (e.g., to predict and / or monitor the progression of osteoporosis, tumor growth, and / or bone metabolism). Similarly, a temperature sensor can be used to monitor the temperature of the bonding agent (which is above body temperature when initially inserted before hardening) and any possible early signs of inflammation or infection.

[0344] The ISM within the bone grafting compound described above can be used to monitor pressure, location, orientation, contact, and other measurements (temperature, pH, etc.) during placement and subsequent follow-up. Once implanted, the ISM contained within the bone grafting compound is identical, regardless of whether it is used for vertebroplasty ( Figures 20A-20E Is it applied as part of vertebroplasty (or as part of kyphoplasty)? Figure 21 A portion of it is applied.

[0345] The aforementioned ISM containing sensors can be continuously monitored to provide the “real-world” range of motion of the spine, aid in the detection of any decline in spinal health, collect and compare procedural performance data over time, assess patient function, and better understand the conditions of real-world exposure to spinal implants.

[0346] B.7B. Intervertebral disc disease / spinal fusion Damage and / or disease of the intervertebral disc can cause substantial, chronic neck and / or back pain and / or neurological symptoms. Examples of chronic intervertebral disc problems include degenerated discs, bulging discs, herniated discs, thinning discs, and degenerated discs with osteophyte formation.

[0347] To address problems associated with intervertebral disc injury or disease, spinal fusion surgery is frequently prescribed. In this procedure, two or more adjacent vertebrae (vertebral bodies) are fused together by creating a “bone bridge” across the damaged / lesioned intervertebral disc (e.g., using autologous or allogeneic bone tissue). For posterolateral spinal fusion, bone fusion is created between the transverse processes of the vertebrae, while in intervertebral spinal fusion, bone grafts are created between the vertebral bodies in an area typically occupied by the intervertebral disc. In the latter case, the intervertebral disc is often completely removed and usually replaced with a plastic or titanium cage to maintain alignment and height and promote bone growth. Fusion can also be enhanced by fixation devices, including metal screws (including pedicle screws and rods), rods or plates for connecting the screws, and wires.

[0348] Spinal fusion devices and spinal fusion surgery are often associated with a number of complications during and after the procedure. Typical complications include vertebral subluxation (abnormal movement between vertebrae), collapse and loss of support of structural elements, tissue reaction to the device, infection, pseudoarthritis, failure to heal properly (i.e., delayed or nonunion of vertebrae), and problems with the implanted device itself, such as: hardware breakage, loosening, and / or migration; pedicle screw breakage, loosening, or displacement; and transition syndrome (i.e., stress exerted on nearby vertebrae due to fusion).

[0349] In various embodiments of the invention, an ISM having one or more sensors can be placed on the instruments and fixation devices described herein to assist in the placement of medical devices and / or implants and to monitor the effectiveness of surgical procedures. For example, the ISM can be placed on a bar fixed by pedicle screws ( Figure 22A ), and can be placed on a plate that can be used to fuse together with the vertebrae ( Figure 22B Given the disclosures provided herein, it should be apparent that ISMs can also be placed on or within pedicle screws, wires, and / or other hardware used in spinal fusion.

[0350] For example, Figure 22A and Figure 22BThe ISM shown may include a positioning sensor that can be used to assess the range of motion of spinal segments (bending and extension of spinal segments, adduction and rotation of spinal segments), improve the accuracy of physical examinations (using 3D data, which can be used to generate images and assess the position and movement of the spine and device, assessing for subluxation between segments), monitor the anatomy of the spine and device (alignment, kyphosis), assess contact and interaction between adjacent device components (e.g., between screws, plates, rods and / or wires), and monitor for breakage, bending, loosening and / or movement of any implanted components. Data collected from the positioning sensor will also allow for both short-term and long-term assessments of product performance, as well as assessments of healing and patient recovery.

[0351] Figure 22A and Figure 22B The ISM shown can also include contact sensors that can be used to detect the space, movement, and integrity of the engagement between the hardware and surrounding tissue, as well as the integrity of connections between various different parts of the hardware (disconnection of hardware components), bending or breakage of hardware parts, and detection of hardware-related loosening and / or osteolysis (bone loss in the tissue surrounding the implanted device; particularly for screws). Data collected from contact sensors will also allow for both short-term and long-term assessments of product performance, as well as assessments of healing and patient recovery.

[0352] Figure 22A and Figure 22B The ISM shown may also include accelerometers and / or strain gauges, which can be used to indicate strains (and / or repetitive strains over time) that can lead to destructive bone remodeling. Additionally, the sensor can detect and record the amplitude, acceleration direction, orientation, vibration, and impact of a given strain. Therefore, loosening of screws in bone, movement between components, vertebral subluxation (anterior displacement of the spine), breakage and / or failure of components, and collapse of structural elements (including damage to surrounding bone) can also be monitored and recorded. The data can also be integrated and used to create 2D and / or 3D images of the hardware and spinal anatomy at a single point and over time based on real-world stress. Such a sensor also allows for continuous monitoring of the device to assess both short-term and long-term product performance, as well as healing and patient recovery.

[0353] A wide variety of other sensors can also be included (alone or in combination). Figure 22A and Figure 22B The ISM shown includes, for example, one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, tissue chemistry sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors.

[0354] B.7.C. Degenerative disc disease (DDD) / Interbody fusion / Spinal cage Degenerative disc disease (also known as vertebral stiffness) is a condition typically associated with aging (although it can also be caused by injury or trauma) and can be associated with chronic neck and / or back pain and peripheral neurological symptoms (numbness, tingling, weakness, bowel and bladder problems). Fibrocartilage typically forms in the intervertebral disc due to aging or repeated injury. The contents of the nucleus pulposus (the gelatinous inner portion of the disc) can bulge or protrude through a weakened area of ​​the annulus fibrosus and come into contact with the spinal cord or spinal nerves. The pressure of the bulging or protruding disc on the spinal cord or spinal nerves causes the previously described pain and neurological symptoms.

[0355] Spinal cages have been developed to assist in intervertebral fusion and can be used to treat degenerative disc disease, herniated discs, and low-grade anterior vertebral displacement. They are typically small, hollow cylindrical devices made of titanium, titanium alloys, stainless steel, or polymers. They can be filled with bone graft materials (allogeneic or autologous grafts) and / or growth factors (e.g., bone morphogenetic protein BMP).

[0356] Currently, a wide variety of spinal cages are commercially available from numerous manufacturers, such as BAK from Sulzer Spine Tech, Ray TFC from Stryker, contact fusion cages from Synthes, and interfix cages and LT cages from Medtronic. Spinal cages can be manufactured to be placed between the vertebrae of the spine in a specific orientation (e.g., vertebral body side and vertical side). Furthermore, the vertical side can be flattened to allow two cages to be placed side-by-side in the intervertebral space. Spinal cages can be encapsulated during surgery with autologous or allogeneic bone graft material, with or without other factors such as bone morphogenetic proteins (“BMPs”), to facilitate bone growth through the perforated walls of the cage and the formation of intervertebral fusion.

[0357] In various embodiments of the invention, the ISM with sensors may be placed on and / or inside the spinal cage (e.g., as shown in the image). Figure 23(As shown). For example, an ISM with positioning sensors can be placed on and / or within a spinal cage, and / or within bone graft material. The sensors can be used to detect and monitor the position and fixation of the affected spinal cage, movement of the cage within the intervertebral space, to monitor for breakage and / or wear of the spinal cage, and to monitor the anatomy, contact, and interaction between adjacent components (especially when using more than one cage). For example, during placement, ISM positioning sensors can be used to determine if the cage is correctly positioned, if the spinal alignment is correct, and if the intervertebral spacing is optimal; after placement, ISM positioning sensors can monitor any movement, migration, or breakage of the spinal cage; furthermore, they can be used to follow the progress of bone fusion, as movement of the spinal cage should gradually decrease as new bone growth successfully fuses the two segments together (and “locks” the cage within the bone mass); conversely, ongoing or increased positional movement will raise concern if fusion is not progressing as expected. Therefore, ISM positioning sensors allow for continuous monitoring of the device, spinal anatomy (alignment, spacing, etc.), and bone fusion to assess both short-term and long-term product performance, as well as healing and patient recovery.

[0358] In other embodiments, the ISM including contact sensors and / or pressure sensors may be placed on or inside the spinal cage (e.g. Figure 23 (As shown) and / or placed within bone graft material. In some embodiments of the invention, two cages are provided with an ISM that allows for the placement of “matching” sensors to enable analysis of movement and / or migration between different (paired) parts of the spinal cage hardware. Contact sensors can also be used to detect the space, movement, and integrity of the engagement between the hardware and developing bone tissue. For example, increased contact and / or decreased pressure between the hardware and surrounding tissue suggests ongoing fusion (i.e., new bone growth is assumed to be compressive and reducing dependence on the cage), while eventual contact / pressure stabilization suggests near-complete healing; such measurements can guide rehabilitation and physical therapy decisions. On the other hand, reduced contact between bone tissue and the cage may suggest insufficient bone growth, failed fusion, or device failure; in this context, increased pressure on the cage would suggest that the device (rather than new bone growth) is subjected to a disproportionate amount of compressive force between the intervertebral bodies. Sensors also allow for continuous monitoring of the device to assess both short-term and long-term product performance, as well as assessments of healing and patient recovery, and can help guide activity and recovery programs.

[0359] In other embodiments, the ISM containing accelerometers and / or strain gauges may be placed on or inside the spinal cage (e.g. Figure 23(As shown) and / or placed within bone graft material. The ISM accelerometer can be used to detect and record the amplitude, direction, orientation, vibration, and impact of a given strain. Therefore, the detection of vibration / movement can indicate loosening within the fused intervertebral disc, movement between paired spinal cage components (if more than one cage is used), breakage / failure of the spinal cage, cage migration, vertebral subluxation (anterior displacement of the spine), collapse and loss of support of structural elements, and damage to surrounding new bone. Data generated from the sensor can also be integrated and used to create 2D and / or 3D images of the hardware and spinal anatomy based on real-world stress at a single time point and over time. The accelerometer provides clinicians with insights into the overall movement and stability of the affected spinal segment (bending, extension, and rotation of the spinal segment, which should all decrease over time if bone fusion is successful). Such sensors also allow for continuous monitoring of the implanted device to monitor both short-term and long-term product performance, as well as assessment of healing and patient recovery. This data helps monitor patient progress and the effectiveness of specific rehabilitation efforts, and helps identify potential activities / movements that are detrimental to recovery.

[0360] As will be apparent from the disclosure provided herein, in addition to the sensors described above, Figure 23 The ISM on the spinal cage (or in the bone graft material) may also have a variety of sensors, including, for example, one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, tissue chemistry sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors.

[0361] B.7.D. Artificial intervertebral disc In various aspects of this invention, intervertebral disc injuries (e.g., injuries or diseases such as degenerative disc disease) can also be treated using artificial intervertebral discs (i.e., by completely replacing the damaged disc with a prosthesis). Unlike spinal fusion, the purpose of artificial intervertebral discs is to maintain movement between vertebrae, for example, to provide more natural spinal flexion, extension, and rotation. Representative artificial intervertebral discs include the Charite lumbar disc (DePuy), the Prodisc lumbar disc (Synthes), the ProDisc cervical disc (Synthes), and the Maverick lumbar disc (Medtronic). Typically, the disc is completely removed by a surgeon via an anterior (abdominal) approach, and a plate (usually made of titanium or titanium alloy) is placed on the vertebral body. A core (usually made of a polymer such as polyethylene) is sized to provide the correct height and positioned between the plates to complete the artificial intervertebral disc.

[0362] In embodiments of the invention, the artificial intervertebral disc is provided with one or more ISMs (see, for example...). Figure 24 For example, in one embodiment, the artificial intervertebral disc is provided with an ISM having one or more positioning sensors, which is placed on and / or within the artificial intervertebral disc (i.e., on or within the metal plate, and / or on / within the articular core between the plates). For glued-in artificial intervertebral discs, one or more ISMs may also be contained within the osteosynthetic material. During surgery, the ISM positioning sensors can be used by the surgeon to determine accurate placement, alignment, and spinal anatomy (medical imaging). Postoperatively, the ISM positioning sensors can be used to detect and accurately monitor the bending, extension, and rotation of the artificial intervertebral disc (precise digital measurements of all movements), as well as to assess, measure, and estimate the range of motion of spinal segments. The ISM positioning sensors can also be used to determine and monitor the position and fixation of the artificial intervertebral disc, the movement of the artificial intervertebral disc, to monitor the anatomy, contact, and interaction between adjacent components (detecting movement of normal components and movement of abnormal components, such as dislocation or subluxation of the artificial joint), and to monitor the migration, breakage, and / or wear of the artificial intervertebral disc. It also allows for continuous monitoring of the device to assess both short-term and long-term product performance, as well as evaluation of healing and patient recovery.

[0363] In other embodiments, Figure 23 The ISM (Interbody Surface Sensor) may have one or more contact sensors and may be placed on and / or within the artificial intervertebral disc (i.e., on or within the metal plate, and / or on / within the articular core between the plates); for glued prostheses, the ISM may be contained within the bone bonding agent. During surgery, the ISM contact sensors can be used by the surgeon to determine the accurate placement, alignment, and contact between the metal plate and surrounding tissues, and between the components of the artificial intervertebral disc (metal plate and articular core). Postoperatively, the ISM contact sensors can also be used to detect the space, movement, and integrity of the joint between the disc hardware (metal plate) and bone, and to detect increased movement (which can indicate bone resorption); monitor articular surface contact (to identify artificial joint dislocation or subluxation); and detect and / or monitor wear, corrosion, migration, and / or failure or breakage of the device. The ISM may also be placed at a critical depth within the polymer articular core to notify the patient and physician when the amount of surface wear on the synthetic joint components becomes relevant. The sensors also allow for continuous monitoring of the device to assess both short-term and long-term product performance, as well as healing and patient recovery.

[0364] In other embodiments, Figure 23The ISM (Intervertebral Spectrometer) may have one or more accelerometers and / or strain gauges and may be located above and / or within the artificial intervertebral disc (e.g., above or within a metal plate, and / or above / within a joint core between plates); for glued prostheses, the ISM may be contained within the osteosynthetic material. The ISM accelerometer can be used to detect and record the amplitude, direction, orientation, vibration, and impact of a given strain. Therefore, the detection of vibration / movement can indicate loosening of the prosthetic intervertebral disc from the surrounding bone (improper fixation or osteolysis); or within the artificial intervertebral disc, vibration / movement can be an indicator of migration / breakage / failure of the artificial intervertebral disc, subluxation or dislocation of the vertebral artificial joint, collapse and loss of support of structural elements, and damage to surrounding new bone. Data generated from the ISM accelerometer can also be integrated and used to create 2D and / or 3D images of the hardware and spinal anatomy at a single point and over time based on real-world stress. The ISM accelerometer provides clinicians with insights into the overall movement and stability of the affected spinal segment, including flexion, extension, and rotation of the segment with the artificial intervertebral disc. Such a sensor also allows for continuous monitoring of the device in “real-world” conditions to assess both short-term and long-term performance, as well as healing and patient recovery. This data helps monitor patient progress and the effectiveness of specific rehabilitation efforts, and helps identify potential activities / movements that are detrimental to recovery.

[0365] In summary, a wide variety of sensor-equipped intramural sphincters (ISMs) can be placed on and / or within artificial intervertebral discs (i.e., on or within metal plates, and / or on and / or within the articular core between plates; for glued prostheses, the ISM may also be contained within the osteosynthetic material) to provide performance assessments in clinical and “real-world” settings, detect loosening between the prosthesis and surrounding bone, detect joint subluxation or dislocation, monitor spinal anatomy and alignment, detect infection and / or inflammation, detect strain encountered in the prosthesis, detect acceleration and impact events, and detect articular surface wear in the metal plates and / or polymer components (if present). For example, an ISM contained on or within an artificial intervertebral disc can have a combination of one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors.

[0366] B.7.E. Microsurgical discectomy In various aspects of this invention, devices and methods for treating herniated intervertebral discs are provided. In short, unlike typical vertebrae, a tear in the annulus fibrosus of an intervertebral disc allows the soft central nucleus pulposus to protrude through the annulus. This can occur due to a variety of causes, such as trauma, elevation, repetitive injury, or may be inherently idiopathic. Such herniated discs can initially be treated conservatively with rest, anti-inflammatory medications, and physical therapy, but in some cases, if nerve roots or the spinal cord are involved and neurological symptoms (numbness, weakness, tingling, paralysis, bowel or bladder dysfunction) are present, surgery may be necessary.

[0367] In a typical surgical procedure, the patient is anesthetized and a small incision is made in the back. The muscles and ligaments of the spine are separated, and a small number of facet joints can be removed. Then, the protruding disc material is removed endoscopically.

[0368] In various embodiments, microsurgical discectomy tools incorporating an ISM with sensors as described herein are provided. For example, in one embodiment, a microsurgical discectomy tool incorporating an ISM with contact sensors is provided, which can be used to monitor contact between the bone forceps and nerve roots, spinal cord, and / or peripheral nerve tissue. A microsurgical discectomy tool incorporating an ISM with pressure sensors can be used to monitor pressure applied to nerve tissue during dissection and to prevent tissue damage and nerve injury due to excessive pressure. A microsurgical discectomy tool incorporating an ISM with positioning sensors and an accelerometer can be used to assist in the resection of herniated disc tissue and for pre- and post-resection medical imaging (e.g., to provide images of the anatomy of the spine and intervertebral disc, the herniated segment, and the disc wall). In some embodiments of the invention, naturally occurring or synthetic nucleoid material may be re-injected back into the intervertebral disc (see generally Eur Spine J., November 2009; online August 18, 2009, 18(11): 1706-1712). In a preferred embodiment, the naturally occurring or synthetic nucleoid material may comprise one or more ISMs with sensors to monitor pressure, location, contact and / or movement within the nucleus, as well as leakage or rupture of the intervertebral disc and inflammation and / or infection of the intervertebral disc.

[0369] In other aspects of the invention, intradiscal electrothermal annuloplasty can be used to treat, for example, degenerative disc diseases. For instance, an electrothermal catheter can be inserted along the posteromedial wall of the intervertebral disc. The catheter can then be heated, thereby thickening the collagen fibers that make up the disc wall (and sealing any ruptures in the disc wall) and cauterizing sensitive nerve endings.

[0370] In various embodiments of the invention, an electrothermal catheter comprising one or more intervertebral disc endoscopic sphincterotomy (ISMs) is provided, each ISM having sensors usable during the procedure of an intradiscal electrothermal annulusoplasty. For example, an ISM with contact sensors can be used to monitor contact between the electrothermal catheter and the inner wall of the annulus. An ISM with pressure sensors can be used to monitor pressure within the annulus to help avoid perforation through the annulus and to confirm the integrity / sealing of the annulus after the surgical procedure. An ISM with positioning sensors and an accelerometer can be used to assist catheter placement and for medical imaging (e.g., to confirm correct catheter placement before and after treatment, and to image spinal and intervertebral disc anatomy). Additionally, an ISM with temperature sensors can be used to control the heat of the catheter to determine and maintain the correct operating temperature (and prevent thermal damage to non-target tissues).

[0371] In summary, one or more ISMs with one or more sensors can be placed on and / or within the instruments used in microsurgical discectomy and electrothermal catheterization to provide surgeons with “real-time” information and feedback during the procedure, detecting instrument placement, the anatomy of the spine and intervertebral discs, the forces applied to surrounding tissues, and physiological conditions encountered during the interventional procedure. For example, the microsurgical discectomy and electrothermal instruments may have one or more ISMs with one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolic sensors, mechanical stress sensors, and temperature sensors.

[0372] As will be apparent from the disclosure provided herein, the ISM described and claimed herein may contain various different sensors in different locations within the ISM. Additionally, in various embodiments of the invention, one or more sensors may be placed separately from the ISM (but still optionally, may be able to communicate with and be controlled by the ISM). Representative examples of sensors placed on spinal implants or spinal devices or surgical delivery devices for spinal implants are provided in U.S. Provisional No. 62 / 017106, which is hereby incorporated herein by reference in its entirety.

[0373] B.8. Orthopedic Hardware In one embodiment of the invention, the ISM is disposed in orthopedic hardware and / or orthopedic implants. The terms “orthopedic device and / or orthopedic implant” as used herein refer to a wide variety of devices (typically hardware) and implants (typically biomaterials such as bone bonding agents, adhesives, bonding agents, hemostatic agents, and bone grafts) that can be implanted into, around, or in appropriate locations within, a part of, or in relation to a subject’s musculoskeletal system (e.g., bone) to facilitate the treatment of a condition, injury, or disorder. Representative conditions that can be treated include musculoskeletal trauma (e.g., falls, injuries, motor vehicle accidents, projectile injuries), sports injuries, degenerative diseases (such as osteoarthritis and other forms of arthritis, osteoporosis), infections (osteomyelitis), tumors (primary and metastatic bone tumors), and congenital conditions (malformations, osteogenesis imperfecta).

[0374] Orthopedic devices and implants can be used both externally and internally to correct musculoskeletal injuries and deformities. Representative examples of external orthopedic devices and implants include, for example: plaster casts (e.g., made of plaster, polyurethane, fiberglass, or thermoplastic; see, for example, U.S. Patent Nos. 4,308,862, 4,817,590, and 6,053,882), braces (see, for example, U.S. Patent Nos. 4,862,878 and 5,437,617), tensor bandages (e.g., elastic bandages that are stretchable and can generate localized pressure; for example, Kendall tensor elastic bandages), slings, supports, and braces (e.g., ACE adjustment pads and Flexibrace®), (generally see “Orthopedic Taping, Wrapping, Bracing & Padding” published by Joel W. Beam, FADavid, Inc., 2006).

[0375] Representative examples of internal hardware and implants include K-wires (K-pins), needles (Schwarzschild wires), screws, plates, and intramedullary devices (e.g., rods and nails) and associated devices. In short, an intramedullary rod or nail (including, for example, interlocking nails, Küntscher nails, Ender nails, Grosse-Kempf (GK) nails, Gamma nails, and Rush nails) is a long metal rod that is implanted into the medullary cavity of a long bone (e.g., the femur, humerus, or tibia) to provide greater stability and support to the bone during healing. A K-wire (or “K-pin”) is a sharpened, smooth needle used to hold bone fragments together or as an anchor for skeletal traction. K-pins come in various sizes and shapes and may be threaded in some embodiments. Orthopedic screws, needles, and plates are used in a wide variety of orthopedic surgical procedures to fasten, stabilize, repair, fix, replace, or secure bone (or bone fragments). Representative orthopedic implants include the Smith Peterson nail for femoral neck fractures, the McLaughin plate (used together with the Smith Peterson nail for intertrochanteric femoral fractures), the Buttress plate for tibial condyle fractures, the blade plate for femoral condyle fractures, dynamic compression plates, Schwarz wires for skeletal traction, the Talwalkar nail for radius and ulna fractures, and the Moore wire for femoral head fractures. Representative examples of the above devices, implants, and equipment are described in the Oxford textbook *Orthopedics and Trauma*, published by Oxford University Press in 2002; (see also U.S. Patent Nos. 6,565,573, 7,044,951, 7,686,808, 7,811,311, 7,905,924, 8,048,134, and 8,361,131), all of which are incorporated herein by reference in their entirety.

[0376] Orthopedic devices or implants can be made of a wide variety of materials, including, for example, metals such as titanium, titanium alloys and / or stainless steel, although other materials may also be used, including polymers such as polymethyl methacrylate or “PMMA”, polyether ether ketone or “PEEK”, and bone graft materials that can be allogeneic, xenogeneic or synthetic; and nonpolymeric materials such as silicon nitride.

[0377] In some embodiments of the invention, the ISM may be placed within an orthopedic device, which is conventionally made of metallic materials (e.g., plates) by various means. For example, in one embodiment, small holes, cavities, or openings may be placed within the device (e.g., using a laser), and one or more sensors may be inserted into the openings. In other embodiments, the surface of the metallic device may be coated with one or more polymers that contain or include one or more ISMs having one or more sensors. In other embodiments, the ISM may be inserted into the “stem” of the device (an intramedullary rod, needle, or nail; a dynamic hip screw) or attached to the surface of the device.

[0378] "Orthopedic implant surgical equipment" or "orthopedic implant delivery equipment" refers to equipment that can be used to introduce orthopedic implants into a patient and / or to surgical equipment that can be used to manipulate bone. Representative examples include electric drills, electric screw devices and electric saw devices, hammers, chisels, and other tools, all of which consist of selected sterilizable components. Other examples include injection devices for adhesives, hemostatic agents, and bone bonding agents.

[0379] The medical devices (e.g., orthopedic devices and implants, orthopedic delivery devices, etc.) and kits provided herein are preferably sterile, pyrogen-free, and / or suitable for use in humans and / or implantation in humans. However, in some embodiments of the invention, the medical devices and / or kits may be prepared in a non-sterile environment (or even customized or “printed” for individual subjects) and sterilized at a later point in time.

[0380] B.8.A. External orthopedic equipment: plaster casts, splints, braces, stretchers, suspension straps, and supports. As described above, in various aspects of the present invention, external orthopedic devices or implants and associated medical devices are provided for use in a wide variety of orthopedic surgical procedures.

[0381] For example, in one embodiment of the invention, the ISM may be placed on, within, and / or under a casting material (e.g., typically plaster on a mesh, fiberglass mesh, or a polymer-based composition such as polyurethane or thermoplastic polymer) to form a plaster clip. In other embodiments, one or more ISMs may be placed on the surface, within, and / or under the 3D-printed plaster clip.

[0382] Such ISMs can be used for a variety of purposes. For example, one of the complications associated with plaster casts is the development of pressure points between the cast and the skin, which can lead to tissue sores, pain, and even tissue necrosis. ISMs with pressure sensors can be used to detect pressure during the application of the cast and while it is in place. Pressure sensors can be used to monitor for inappropriate or dangerous increases in pressure (e.g., which may occur with inflammation that develops several days after an injury or after walking) and serve as a basis for alerting patients, healthcare providers, or other entities or objects, as discussed in more detail below.

[0383] An ISM with accelerometers and / or positioning sensors can be used in plaster casts to monitor joint movement and fixation, ensuring that excessive stress is not applied to the cast body parts. Proper fracture healing typically requires not only stabilizing bone fragments but also immobilizing the joints above and below the fracture. Accelerometers and / or positioning sensors help ensure that underlying structures (e.g., bone) maintain proper alignment and that the associated joints are adequately stabilized. Additionally, ISM accelerometers and positioning sensors can be used to monitor torsion, torque, flexion, extension, and bending, all of which can lead to complications such as inadequate or improper healing.

[0384] In some embodiments, an ISM with an external accelerometer and / or positioning sensor may be associated with a sensor that has been placed in the body (e.g., implanted by injection or surgery, or associated with an internal orthopedic implant as described in more detail below).

[0385] For example, such as Figures 25A-25C As shown, an ISM (e.g., an ISM having one or more of an accelerometer, a positioning sensor, a pressure sensor, etc.) can be placed on an external support structure (see, for example, see...). Figure 25A An ISM (e.g., an ISM having one or more of an accelerometer, positioning sensor, pressure sensor, etc.) can be placed on various aspects of a support structure (including, for example, on an external screw, pin, clamp, or other support structure), and on various aspects of an orthopedic device or implant inserted into the bone (e.g., as shown in the image). Figure 25B The radius shown is above or in the arm (where it is implanted). Figure 25C Movement between internal (implanted) and external sensors can be used to assess whether anatomical segments have become misaligned and whether such misalignment may require adjustment or correction in further procedures.

[0386] In other embodiments, an ISM with both chemical and temperature sensors can be used to monitor skin temperature, skin integrity, and / or the presence of an infection or developing infection. The ISM sensor, positioned within a plaster cast or splint that comes into contact with the skin, is ideally positioned to perform this function.

[0387] In other embodiments of the invention, the ISM can be placed on various supports, braces, suspension straps, clamps, and stretchers. For example, such as Figures 26A-26B As shown, one or more ISMs can be placed on the knee brace ( Figure 26A ), head and neck braces ( Figure 26B Tensor bandages (not shown), arm suspension belts (not shown), and back braces (not shown) are used.

[0388] In other embodiments of the invention, the ISM can be placed in various locations within a sports helmet designed to protect the athlete, such as, but not limited to, football, ice hockey, and lacrosse helmets. The ISM, equipped with an accelerometer and gyroscope, can measure continuous impact forces and G-forces during play and monitor the effects of acute and cumulative concussions to assess potential brain injury in real time.

[0389] In various embodiments, an ISM with one or more pressure sensors may be placed in any of the braces, stretchers, suspensions, or supports provided herein. An ISM with pressure sensors can be used to measure compressive, rotational, and axial loads, as well as support volume. Detection of increased pressure can indicate the likelihood or potential for skin and / or tissue damage. Detection of decreased pressure can indicate that the device may be ineffective and / or requires reapplication or replacement. Rapid increases or decreases in pressure can indicate traumatic events. For example, detection of a rapid increase in pressure can indicate swelling, improper movement, and / or the risk of tearing or injury, or even the occurrence of compartment syndrome. A rapid decrease in pressure can indicate complete device failure.

[0390] In other embodiments of the invention, the ISM with accelerometer (and strain gauge) may be placed in any of the braces, stretchers, suspensions, splints, or supports provided herein. ISMs containing accelerometers can be used to monitor alignment, stability, and healing. They can also be used to monitor and assess patient activity levels (e.g., daily functioning, range of motion, physical therapy, rehabilitation, and exercise) and to monitor rotation, bending, breakage, movement, and / or slippage of the device.

[0391] In other embodiments of the invention, an ISM with positioning sensors (and location markers such as GPS) may be placed in any of the braces, stretchers, suspensions, splints, or supports described herein. An ISM incorporating positioning sensors (and location markers) can be used to monitor any changes in, for example, anatomy, alignment, or mobility. Additionally, by using the location sensors, patient activity, compliance, mobility / immobility, the effectiveness of rehabilitation, and falls, injuries, or emergencies can be monitored.

[0392] In other embodiments, an ISM with chemical and temperature sensors can be used to monitor skin temperature, skin integrity, and / or the presence of an infection or developing infection.

[0393] In summary, ISMs with a wide variety of sensors can be placed on and / or within the external orthopedic hardware described herein to provide “real-time” information and feedback to healthcare providers (or surgeons during surgical procedures) to detect proper placement, anatomy, alignment, mobility / immobility (of injured tissue and associated joints), forces applied to surrounding tissues, and strain encountered during surgical procedures. For example, the external orthopedic hardware provided herein (e.g., plaster casts, splints, braces, stretchers, suspensions, and supports) may have one or more ISMs comprising combinations of contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. ISMs can be placed at densities of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per square centimeter, or at densities of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per cubic centimeter. In any of these embodiments, there may be fewer than 50, 75, or 100 sensors per square centimeter or per cubic centimeter, or there may be 100 sensors.

[0394] The ISM described above can be monitored continuously or intermittently to provide "real-world" activity, immobility, mobility / immobility, healing, progressive rehabilitation, and function (of the affected limb, joint, etc.), and to collect and compare procedural performance data over time, assess patient activity, and better understand the conditions of implant exposure in the real world.

[0395] B.8.B. Internal orthopedic hardware: K-pins, needles, screws, plates, and intramedullary devices In other aspects of the invention, ISMs are provided for incorporation into a wide variety of internal orthopedic devices. These include, for example, Kirschner wires or “K-wires,” needles, screws, plates, and intramedullary devices (e.g., rods and nails) for repairing fractured, dislocated, and injured musculoskeletal tissue.

[0396] B.8.B.1. needle Needles are common orthopedic devices and are often used as a method to stabilize fractures. One of the most common types of needles is the Schüco needle (sometimes also called an intramedullary needle or IM needle), which is inserted through the skin and into the bone to provide anchoring or support for the patient's fracture. Most commonly, the needle has a bi- or tri-sided cannulated tip (which is better suited for penetrating cortical bone). Figure 27 An embodiment is illustrated in which the ISM is placed on or within a plurality of needles.

[0397] In one embodiment of the invention, the needle is provided with an ISM having one or more pressure sensors. The pressure sensors may be distributed on or within the needle at specific or random locations. In some embodiments, the ISM may be concentrated on the cutting end of the needle. The ISM pressure sensors can be useful during needle placement and removal (if necessary), and during movement through different tissues [e.g., to determine soft tissue (low pressure), cortical bone (high pressure), cancellous bone (moderate pressure), bone marrow (low pressure), fracture surface (less to no pressure) - to aid in detection, placement, and anatomical location].

[0398] ISM pressure sensors can also be useful after needle placement. For example, detecting elevated pressure on the needle or across the fracture surface can indicate the potential for stress shielding (e.g., decreased bone density due to excessive stress borne by the implanted needle and insufficient stress borne by the bone tissue) and / or an increased likelihood of needle bending, breakage, or fracture. Detecting elevated pressure on the needle in soft tissue can indicate the likelihood of compartment syndrome. Detecting decreased pressure on the needle or across the fracture surface can indicate the likelihood of nonunion (early in the healing process) or successful completion of healing (later in the healing process when the bone has acquired normal support function). Uneven and / or unbalanced pressure on the needle or across the fracture surface may be an indication of misalignment, displacement, and / or application of torque to the healing bone. In all cases, identifying the presence of inappropriate pressure across the fracture surface allows for proactive intervention to better stabilize the injury and prevent further damage to the bone.

[0399] In other embodiments, the needle is provided with an ISM equipped with an accelerometer (and strain gauge). The ISM with the accelerometer (and strain gauge) may be distributed on or within the needle at specific or random locations. However, in some embodiments, the ISM may be concentrated on the cutting end of the needle. The ISM accelerometer sensors can be useful during needle placement and removal (if necessary) by being able to detect movement through different tissues; they can also aid in achieving proper anatomical placement, alignment, and imaging during surgery.

[0400] After needle insertion, ISM accelerometers and strain gauges can also be useful. For example, they can be used postoperatively to monitor alignment, stability, fragment mobility / immobility, healing, patient activity, stress across the fracture, and associated joint fixation (or its inadequacy).

[0401] In another embodiment of the invention, the needle is provided with one or more ISMs having one or more positioning sensors / position marker sensors. The ISMs containing the positioning sensors / position marker sensors may be distributed on or within the needle at specific or random locations. In some embodiments, the ISMs may be concentrated on the cutting end of the needle. The positioning sensors / position marker sensors can be useful during needle placement and removal (if necessary), during movement through different tissues (e.g., to determine soft tissue, cortical bone, cancellous bone, bone marrow, fracture surface—to aid in anatomical location, determination and detection of fracture anatomy, and proper post-surgical alignment), and in imaging and functional monitoring after placement.

[0402] ISM positioning sensors / position marker sensors can also be useful after needle placement. For example, they can be used to monitor healing anatomy and (e.g., after surgery) compare changes in position over time. They can also be used to monitor alignment, displacement, and migration to confirm joint fixation and to detect wire bending and / or breakage.

[0403] In other embodiments of the invention, the needle is provided with an ISM having a temperature sensor and / or a chemical sensor. In short, the temperature sensor and / or chemical sensor can be used to monitor the temperature of the skin and tissue, the integrity of the skin and tissue, and / or the presence of infection or developing infection [e.g., bone infection (osteomyelitis) and / or tissue necrosis].

[0404] As will be apparent from the disclosure provided herein, the needle of the present invention may have one or more ISMs, each ISM having a combination of one or more contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, positioning sensors, accelerometers, impact sensors, rotation sensors, vibration sensors, tilt sensors, pressure sensors, histochemical sensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. The sensors may be arranged at densities greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per square centimeter, or at densities greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per cubic centimeter. In any of these embodiments, there may be fewer than 50, 75, or 100 sensors per square centimeter or per cubic centimeter, or there may be 100 sensors.

[0405] The sensor-equipped ISM can be monitored continuously or intermittently to provide a “real-world” assessment of bone alignment, assist in detecting the mobility / immobility of fractures (and associated joints), monitor healing and the development of complications, collect and compare procedural performance data over time, assess patient function, and better understand the conditions under which the implant is exposed in the real world.

[0406] B.8.B.2. Kirschner wire Kirschner wires (or K-wires) are sharpened, sterilized steel wires originally developed by Martin Kirschner in 1909. They followed Kirschner wires when Dr. Kirschner recognized that larger needles caused more bone damage and infection. Dr. Kirschner created his own device made of chrome piano wire to provide better tension when aligning broken fragments of bone into place. Thus, the fundamental difference between wire and needle lies in size. Smaller diameters are called wires, while larger diameters are called needles. While there is no standardized definition for the diameter cutoff, needle diameters typically range from 1.5 mm to 6.5 mm, with K-wires ranging from 0.9 to 1.5 mm in diameter.

[0407] K-needles are typically made of metal (e.g., stainless steel or nickel-titanium alloy) and come in various sizes, diameters, and lengths. They are commonly used to hold bone fragments together, to provide anchors for bone fixation, or as guides for screw placement, and are usually driven into the bone using an electric drill or hand drill. Figure 28 An embodiment is illustrated in which the ISM is placed on and / or within a plurality of K-pins.

[0408] In one embodiment of the invention, the K-needle is provided with an ISM having one or more pressure sensors. The ISM may have pressure sensors and may be distributed on or within the K-needle at specific or random locations. In some embodiments, the ISM may be concentrated on the cutting end of the K-needle. The ISM pressure sensors may be useful during the placement and removal of the K-needle (if necessary), during movement through different tissues [e.g., to determine soft tissue (low pressure), cortical bone (high pressure), cancellous bone (moderate pressure), bone marrow (low pressure), fracture surface (less to no pressure) - to aid in detection, placement, and dissection].

[0409] ISM pressure sensors can also be useful after placement of the K-needle. For example, detecting elevated pressure on or across the fracture surface of the K-needle can indicate the potential for stress shielding and / or an increased likelihood of needle bending, breakage, or fracture. Detecting elevated pressure on the K-needle in soft tissue can indicate the potential for compartment syndrome. Detecting decreased pressure on or across the fracture surface of the K-needle can indicate the likelihood of nonunion (early in the healing process) or successful completion of healing (later in the healing process when the bone has acquired normal support function). Uneven and / or unbalanced pressure on or across the fracture surface of the K-needle may be an indication of misalignment, displacement, and / or application of torque to the healing bone. In all cases, identifying the presence of inappropriate pressure across the fracture surface allows for proactive intervention to better stabilize the injury and prevent further damage to the bone.

[0410] In other embodiments, the K-needle is provided with an ISM equipped with an accelerometer (and strain gauge). Similar to an ISM with a pressure sensor, the ISM with an accelerometer (and strain gauge) may be distributed on or within the K-needle at specific or random locations. However, in some embodiments, the ISM may be concentrated on the cutting end of the K-needle. The ISM accelerometer sensors are useful during the placement and removal of the K-needle (if necessary) by being able to detect movement through different tissues; they can also aid in achieving proper anatomical placement, alignment, and imaging during the procedure.

[0411] After the insertion of the K-needle, the ISM accelerometer and strain gauge can also be useful. For example, they can be used postoperatively to monitor alignment, stability, fragment mobility / immobility, healing, patient activity, stress across the fracture, and associated joint fixation (or its inadequacy).

[0412] In another embodiment of the invention, the K-needle is provided with one or more ISMs having one or more positioning sensors / position marker sensors. The ISMs with positioning sensors / position marker sensors may be distributed on or within the K-needle at specific or random locations. In some embodiments, the ISMs may be concentrated on the cutting end of the K-needle. Positioning sensors / position marker sensors can be useful during K-needle placement and removal (if necessary), during movement through different tissues (e.g., to determine soft tissue, cortical bone, cancellous bone, bone marrow, fracture surface—to aid in anatomical location, determination and detection of fracture anatomy, and proper post-surgical alignment), an...

Claims

1. A sensor data system, comprising: Implantable medical devices, including: - A spinal cage defining a hollow internal space, the spinal cage being configured to receive bone graft material and to be implanted into, around, or in place of a portion of the spine; and - At least one sensor module configured to be placed within the bone graft material within the hollow interior space, the at least one sensor module including a power supply, at least one sensor channel having a sensor, a memory, and a communication interface, the sensor being configured to generate a sensor signal representing the sensed quantity; and The remote data receiving device is configured as follows: - Establish communication with the implantable medical device; and - Receive data representing the sensed quantity.

2. The sensor data system according to claim 1, wherein, The sensors include those selected from accelerometers and gyroscopes.

3. The sensor data system according to claim 1, wherein, The sensors include both gyroscopes and accelerometers.

4. The sensor data system according to claim 1 further includes an implantable housing, wherein, The at least one sensor module is disposed within the implantable housing.

5. The sensor data system according to claim 1, wherein, The sensor channel includes power management circuitry to manage voltage transfer from the power source to the sensor in the at least one sensor channel.

6. The sensor data system according to claim 1, wherein, The remote data receiving device is configured as follows: Process the received data; and Displays the received data that has been processed.

7. The sensor data system according to claim 1, wherein: The sensor is a positioning sensor; The sensed quantities represent the relative or absolute position of the spinal cage; and The remote data receiving device is configured to receive multiple data representing quantities sensed over time, process the received data, and display the processed received data as a function of time to represent at least one of the following: fixation of the spinal cage, movement of the spinal cage, integrity of the spinal cage, and contact and interaction between the spinal cage and adjacent anatomical structures.

8. The sensor data system according to claim 1, wherein: The sensor is a contact sensor; The sensed quantity represents the contact between the spinal cage and the surrounding tissue; as well as The remote data receiving device is configured to receive multiple data representing quantities sensed over time, process the received data, and display the processed received data as a function of time to represent at least one of the following: movement of the spinal cage, detection of space between the spinal cage and surrounding anatomical structures, and integrity of the engagement between the spinal cage and surrounding anatomical structures.

9. The sensor data system according to claim 1, wherein: The sensor is a pressure sensor; The sensed quantity represents the force on the spinal cage; as well as The remote data receiving device is configured to receive multiple data representing quantities sensed over time, process the received data, and display the processed received data as a function of time to represent the pressure on the spinal cage.

10. The sensor data system according to claim 1, wherein, The sensor is an accelerometer, and the sensed quantity represents the movement of the spinal cage.

11. The sensor data system according to claim 10, wherein, The remote data receiving device is configured to receive multiple data representing quantities sensed over time, process the received data, and display the processed received data as a function of time to represent at least one of the following: the acceleration amplitude of the spinal cage, the acceleration direction of the spinal cage, the orientation of the spinal cage, and the vibration of the spinal cage.

12. The sensor data system according to claim 1, wherein: The sensor is a strain gauge; The sensed quantity represents the strain between the spinal cage and the tissue surrounding the spinal cage; and The remote data receiving device is configured to receive multiple data representing quantities sensed over time, process the received data, and display the processed received data as a function of time to represent the strain between the spinal cage and the tissue surrounding the spinal cage.

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