WO2024224327A1

WO2024224327A1 - Battery powered smart spinal implants

Info

Publication number: WO2024224327A1
Application number: PCT/IB2024/054038
Authority: WO
Inventors: Newton Metcalf; Arjun Siby Kurian KURIAN; Jerald Redmond; Mark Dace; Keith Miller; Kevin T. Foley
Original assignee: Warsaw Orthopedic Inc
Current assignee: Warsaw Orthopedic Inc
Priority date: 2023-04-26
Filing date: 2024-04-25
Publication date: 2024-10-31
Anticipated expiration: 2025-10-26
Also published as: CN121001654A

Abstract

This document discloses systems and methods related to spinal implants having sensors. For example, an implant system includes one or more anchoring members, an electronics system including a battery and an antenna, and a longitudinal member. The longitudinal member is configured to be secured to at least two of the one or more anchoring members, the longitudinal member including one or more electronics housings configured to contain the battery or the antenna of the electronics system. The one or more sensors are configured to obtain measurements of a property associated with the longitudinal member, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device.

Description

BATTERY POWERED SMART SPINAL IMPLANTS

FIELD

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/498,336, filed 26 April 2024, the entire content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to mechanical and electrical sensor assemblies and antenna designs for implant devices, and more particularly to spinal implant systems which may be used to treat various spinal disorders.

BACKGROUND

[0003] Treatment of spinal disorders, such as degenerative disc disease, disc herniations, scoliosis or other curvature abnormalities, and fractures, often requires surgical treatments. For example, spinal fusion may be used to limit motion between vertebral members. As another example, implants may be used to preserve motion between vertebral members.

[0004] Surgical treatment typically involves the use of implants and longitudinal members, such as spinal rods. Implants may be disposed between two vertebral members for supporting and/or repositioning the vertebral members. Implants may also be used to facilitate a fusion process between a superior vertebra and an inferior vertebra. Longitudinal members may be attached to the exterior of two or more vertebral members to assist with the treatment of a spinal disorder. Longitudinal members may provide a stable, rigid column that helps bones to fuse, and may redirect stresses over a wider area away from a damaged or defective region. Rigid longitudinal members may also help in spinal alignment. [0005] Screw assemblies may be used to connect a longitudinal member to a vertebral member. A screw assembly may include a pedicle screw, hook, tulip bulb connector or other type of receiver, and a set screw, among other components. A pedicle screw can be placed in, above and/or below vertebral members that were fused, and a longitudinal member can be used to connect the pedicle screws which inhibit or control movement. A set screw can be used to secure the connection of a longitudinal member and a pedicle screw, hook, or other connector. Implants may include one or more sensors for monitoring aspects of the treatment and transmitting sensor data to an external reader. However, the configuration of an antenna may be constrained by the patient’s anatomy, reducing the antenna’s effectiveness. Furthermore, the tissue surrounding the implants can attenuate transmitted signals. This document describes methods and systems that are directed to addressing the problems described above, and/or other issues.

SUMMARY

[0006] The techniques of this disclosure generally relate to spinal implants having various sensors for communicating attributes about the spinal implants, when installed in patient anatomy, to an external reader.

[0007] In a first example embodiment, an implant system is disclosed. The implant system includes one or more anchoring members, an electronics system including a battery and an antenna, and a longitudinal member. The longitudinal member is configured to be secured to at least two of the one or more anchoring members, the longitudinal member including one or more electronics housings configured to contain the battery or the antenna of the electronics system. The one or more sensors are configured to obtain measurements of a property associated with the longitudinal member, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device. [0008] Implementations of the disclosure may include one or more of the following optional features. In some examples, the longitudinal member is configured to contain the antenna and the battery within the longitudinal member. The longitudinal member may be configured to contain the antenna near a first end of the longitudinal member and to contain the battery near a second end of the longitudinal member. The longitudinal member may include one or more removable end caps configured to contain the battery or the antenna. The implant system may further include a second longitudinal member configured to be secured to each of one or more second anchoring members. In some embodiments, the second longitudinal member does not include a sensor. At least one of the one or more electronics housings may include a C-clamp configured to attach to the longitudinal member. The C-clamp may be further configured to attach to one or more vertebrae. In some examples, the one or more sensors include an accelerometer, gyroscope, strain gauge, pressure sensor, pH sensor, impedance sensor, optical sensor, or temperature sensor.

[0009] In a second example embodiment, an implant system is disclosed. The implant system includes an electronics system including a battery and an antenna, a removable electronics housing configured to contain the battery and/or the antenna of the electronics system, and one or more interbody cages configured to receive the removable electronics housing. The implant system further includes one or more sensors configured to obtain measurements of a property associated with the one or more interbody cages, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device. [0010] Implementations of the disclosure may include one or more of the following optional features. In some examples, the removable electronics housing is configured to fit around a perimeter of at least one of the one or more interbody cages. The removable electronics housing may be elastic. The removable electronics housing may be configured to attach to the bottom of at least one of the one or more interbody cages. The removable electronics housing may be rigid. In some examples, the implant system further includes a spinal construct including one or more relay devices configured to receive the transmitted sensor measurements and retransmit the transmitted sensor measurements to an external reader device.

[0011] In an third example embodiment, an implant system is disclosed. The implant system includes an electronics system including a battery and an antenna, a removable electronics housing configured to contain the battery and/or the antenna of the electronics system, and a longitudinal member configured to be secured to at least two of the one or more pedicle screws. The implant system further includes one or more sensors configured to obtain measurements of a property associated with the longitudinal member, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device. [0012] Implementations of the disclosure may include one or more of the following optional features. The removable electronics housing may be configured to engage with a threaded portion of at least one of the one or more pedicle screws. In some examples, the removable electronics housing is elongate and the removable electronics housing is oriented such that its longitudinal axis is parallel with the longitudinal axis of the longitudinal member. The removable electronics housing may be retained via a mechanical-linking feature. The removable electronics housing may be a threaded cap configured to secure the longitudinal member to at least one of the one or more pedicle screws.

BRIEF DESCRIPTION OF DRAWINGS

[0013] FIG. 1 illustrates an example of a surgical site monitoring system according to an embodiment.

[0014] FIGs. 2A-2B illustrate an example embodiments of a pedicle screw system.

[0015] FIGs. 3A-3C illustrate other example embodiments of a pedicle screw system.

[0016] FIGs. 4A-4B illustrate other example embodiments of a pedicle screw system.

[0017] FIGs. 5A-5B illustrate an example embodiment of a spinal construct system.

[0018] FIG. 6 illustrates another example embodiment of a spinal construct system.

[0019] FIG. 7A-7B illustrate example embodiments of an interbody cage system.

[0020] FIG. 8 illustrates an example embodiment of a telemetry relay system.

DETAILED DESCRIPTION

[0021] Embodiments of the present disclosure relate generally, for example, to spinal implant systems with active sensing, microelectronics, and communication abilities. Embodiments of the devices and methods are described below with reference to the Figures.

[0022] The following discussion omits or only briefly describes certain components, features and functionality related to medical implants, installation tools, and associated surgical techniques, which are apparent to those of ordinary skill in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views, where possible. Reference to various embodiments does not limit the scope of the claims appended hereto because the embodiments are examples of the inventive concepts described herein. Additionally, any example(s) set forth in this specification are intended to be non-limiting and set forth some of the many possible embodiments applicable to the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations unless the context or other statements clearly indicate otherwise.

[0023] Terms such as “same,” “equal,” “planar,” “coplanar,” “parallel,” “perpendicular,” etc. as used herein are intended to encompass a meaning of exactly the same while also including variations that may occur, for example, due to manufacturing processes. The term “substantially” may be used herein to emphasize this meaning, particularly when the described embodiment has the same or nearly the same functionality or characteristic, unless the context or other statements clearly indicate otherwise. The term “about” may encompass a meaning of being +/- 10% of the stated value.

[0024] Unless otherwise specifically defined herein, all terms are to be given their broadest possible interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and/or as defined in dictionaries, treatises, etc. It must also be noted that, as used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless otherwise specified, and that the terms "comprises" and/ or "comprising," when used in this specification, specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

[0025] The disclosed medical-implant embodiments include pedicle screws, interbody cages, and other devices that are configured to provide telemetry to an external device. Telemetry data may include position/motion information, force/strain information, temperature, tissue impedance, and so forth. For example, the spinal implants may be installed during a surgical procedure such as a spinal fusion and may be configured to sense aspects of the patient’s postoperative recovery, such as forces between spinal implants or the status of a fusion process (e.g., by measuring impedance of bone graft). The spinal implants may provide telemetry related to the surgical site, such as temperature readings from a variety of locations around the surgical site, e.g., to sense and localize an infection. The spinal implants may provide telemetry related to motion of the patient’s spine, e.g., while performing a post-operative diagnostic regimen. In these cases and others, an external reader, such as the system disclosed in U.S. Patent Publication No. US20210330249A1 , incorporated herein by reference in its entirety, may display or otherwise provide the telemetry to a medical professional for evaluation. The external reader may also receive telemetry from other sources such as, but not limited to, one or more wearable sensor system that are affixed to the patient. The reader device itself may include additional sensors as well.

[0026] The medical implants may include electronics, such as sensors or sensor systems which acquire the telemetry data, and transmitter (or transceiver) systems which transmit the telemetry to an external reader/receiver device. The spinal implants may also include a power source, such as a battery (rechargeable or otherwise) for powering the electronics. The transmitter system may include an antenna for radiating the telemetry signal to the reader device (and/or an intermediate relay device). However, the antenna size and/or configuration may be constrained by the patient’s anatomy in various ways, reducing the antenna’s effectiveness. For example, the transmitter may need to transmit the telemetry through six or more inches of tissue to reach an external reader device. This distance may be near the limit for effective telemetry. The size of the power source may also be constrained (e.g., by the patient’s anatomy or for regulatory reasons, etc.), limiting the possible strength of the transmitted signal (e.g., while achieving reasonable battery lifetime or reasonable time between battery recharges).

[0027] The disclosed implant systems may be employed, for example, with minimally invasive procedures, including percutaneous techniques, mini-open and open surgical techniques to deliver and introduce instrumentation and/or one or more spinal implants at a surgical site within a body of a patient, for example, a section of a spine. In some embodiments, the implant system may be employed with surgical procedures, as described herein, and/or, for example, corpectomy, discectomy, fusion and/or fixation treatments that employ spinal implants to restore the mechanical support function of vertebrae. In some embodiments, the implant system may be employed with surgical approaches, including but not limited to: Anterior Lumbar Interbody Fusion (ALIF), Direct Lateral Interbody Fusion (DLIF), Oblique Lateral Lumbar Interbody Fusion (OLLIF), Oblique Lateral Interbody Fusion (OLIF), Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Interbody Fusion (PLIF), various types of posterior or anterior fusion procedures, and any fusion procedure in any portion of the spinal column (sacral, lumbar, thoracic, and cervical).

[0028] FIG. 1 illustrates an example of a surgical site (SS) monitoring system 300 that may utilize example digital pedicle screws 102 and/or digital spinal interbody implants 108 disclosed herein to provide telemetry to an external reader 302. In some embodiments, the SS monitoring system 300 may be a surgical site load monitoring system (using one or more strain gauges 142) and/or an infection monitoring system (using one or more temperature sensors 142). In at least one embodiment, a temperature sensor 142 is positioned to discern a temperature of a patient in the region of the digital spinal interbody implant 108, and in others a temperature sensor 142 is positioned to discern a temperature of a patient in a region adjacent a portion of digital pedicle screw 102 that is directly exposed to patient tissue or contacting a portion of a longitudinal member 106.

[0029] In one or more embodiments, the SS monitoring system 300 may include an array of implants, in which one or more of the implants have any type of MEMs sensor 142 as disclosed herein. For the cases in which the SS monitoring system 300 includes an array of implants having various MEMs sensors 142, the received data from the one or more MEMs sensors 142 may be compared to one another to diagnose the quality of the surgical procedure, the integrity of the implant, and/or an infection at the surgical site.

[0030] FIG. 2A illustrates an example implant system 100. The implant system 100 includes a digital pedicle screw system 102 with active sensing ability. In some embodiments, cortical screws may be used instead of pedicle screws. As illustrated in FIG. 2A, system 100 may include a pedicle screw 102 and a receiver 110 having a side portion 120 for supporting various electronic components and sensors as will be explained in further detail below. The pedicle screw 102 may have a thread pitch extending along a length thereof for implanting and securing the pedicle screw 102 into patient anatomy, e.g., a vertebral body. In various embodiments the receiver 110 includes a substantially U-shaped cavity saddle configured to receive and capture a longitudinal member 106 disposed in the U- shaped cavity. A set screw 104 may engage to threads of (e.g., each respective arm of) the U-shaped cavity of receiver 110. When sufficiently tightened, set screw 104 may immobilize and/or secure the longitudinal member 106 within the U-shaped cavity of receiver 110. Example electronics components may include a (flexible) circuit board providing an electrical connection between the battery (144, FIG. 3A), antenna (146, FIG. 3A), sensor 142 (e.g., strain gauge, temperature sensor), and the various other electronics components. A non-limiting list of example electronics components may include a mainboard or other suitable printed circuit board (PCB), an application specific integrated circuit (ASIC), a micro controller, a wake-up sensor, a memory storage, a charge storage capacitor, and various mechanical electrical sensors or micro electromechanical systems (MEMs). Example MEMs may include a strain gauge, an impedance sensor, and/or a temperature sensor. However, other MEMs sensors may be incorporated in other embodiments depending on the particular use case.

[0031] In the embodiment illustrated in FIG. 2A, the side portion 120 includes a threaded region 130 configured to receive a sensor cartridge 140. The sensor cartridge 140 may include a matching exterior threaded region allowing the sensor cartridge 140 to be screwed into the side portion 120. The sensor cartridge 140 may also include one or more sensors 142, such as impedance sensors, position/motion sensors, force sensors, temperature sensors, etc. In an embodiment, the sensor cartridge 140 includes a strain gauge 142. The strain gauge may be located at a distal end of the sensor cartridge 140, i.e., the end facing toward the longitudinal member 106, so that when the sensor cartridge 140 is screwed into the side portion 120, the strain gauge 142 presses against the longitudinal member 106, or otherwise senses loads associated with the longitudinal member 106. One or more measurements received from a strain gauge 142 may be used to determine the condition of a spinal implant and/or treatment of a spinal disorder. For instance, proper placement of a longitudinal member 106, pedicle screw 102 and/or other implant or implant component may result in an acceptable range of force measurements. However, measurements outside of this range may indicate an issue with the placement or positioning of one or more implant components such as, for example, loosening of a set screw 104 and/or pedicle screw 102, failure of a longitudinal rod 106, construct failure, yield or fracture/breakage, improper torque, breakage of the bone segment or portion, and/or the like. Force measurements may also indicate the occurrence (or absence) of fusion or amount of fusion, etc.

[0032] Similarly, the sensor cartridge 140 may include one or more temperature sensors 142, e.g., positioned to sense the temperature of the surgical site or, e.g., at one position within the surgical site. The cartridge 140 may be a modular design of standard dimensions such that it can be installed within the side portion 120 of selected implant systems 100, leaving other implants without an installed sensor cartridge 140. In some embodiments, the cartridge 140 may be removably attach ed/retained using a cam lock, click-lock feature, or similar mechanical-linking feature configured to provide flexible/selectable integration. In other embodiments, the sensor cartridge 140 has an unthreaded exterior surface and may simply be pressed into position. In some embodiments, the cartridge 140 is surrounded by one or more O-rings or other structure to enhance retention of the cartridge 140 within the implant. In some embodiments the cartridge 140 includes a battery 144 of sufficient electrical storage capacity as to last for a typical patient-recovery period. In some embodiments, the battery 144 may be rechargeable to extend the battery’s service life. The cartridge 140 may also include an antenna 146. The antenna 146 and battery 144 may be contained within the cartridge 140 to form a modular cartridge which can be selectively installed in various spinal implants 100.

[0033] Referring to FIG. 2B, another implant system 100 is shown. As illustrated, the implant system 100 includes a digital pedicle screw system 102 with active sensing ability. As in other embodiments, cortical screws may be used instead of pedicle screws. As illustrated in FIG. 2B, system 100 includes a pedicle screw 102 and a side portion 120. In this embodiment, the antenna 146 is configured to occupy an area near the top of the side portion 120, e.g., an area closest to an external reader 302. The side portion 120 also houses a battery 144, a strain gauge (or other sensor) 142, and associated electronics. In some examples, a strain gauge 142 measures forces associated with a longitudinal member 106 secured within the implant 100.

[0034] Referring generally to FIGs. 3A-3C, additional embodiments are illustrated. In these embodiments, the modular cartridge 140 may be oriented such that its longitudinal axis is parallel with the longitudinal axis of the longitudinal member 106. This orientation may provide for a relatively large cartridge 140 while maintaining a relatively compact overall spinal construct. That is, the relatively larger cartridge 140 does not extend or protrude laterally away from the spinal construct. Instead, the cartridge 140 occupies space substantially adjacent to the longitudinal member 106, providing a compact overall construct. As shown, the modular cartridge 140 contains the battery 144 near one end and the antenna 146 near the other end. Additional electronics may be located between the battery 144 and the antenna 146. The modular cartridge 140 may also include one or more sensors and/or may interface with sensors of the pedicle screw 102. The relatively larger cartridge 140 may include a relatively larger battery 144 and/or a relatively larger antenna 146. A relatively larger battery 144 provides for relatively greater service life and, thus, the ability for the spinal implant 100 to provide telemetry for a relatively greater period of time. A relatively larger antenna 146 may provide for a stronger transmitted signal and/or greater sensitivity to received signals and, thus, enhanced telemetry capability. Furthermore, the illustrated position of the cartridge 140 (near the head 103 of the spinal implant 100) is relatively close to the surface (e.g., skin) of the patient and, therefore, relatively close to an external reader 302. Thus, the depth of signalattenuating tissue that the telemetry signals must travel through between the antenna and external reader 302 is relatively small.

[0035] FIG. 3A shows side and top views of the receiver 110. As shown in FIG. 3A, the modular cartridge 140 is coupled to a side of the side portion 120 and (as disclosed above) relatively close to the surface of the patient and, therefore, some distance from the spine of the patient. This orientation may provide additional packaging benefits. For example, the size of the side portion 120 may be reduced near the spine of the patient. In some examples, portions of the side portion 120 that are closest to the spine of the patient may be contoured or sculped to allow for a close fit with the anatomy of the patient (See, e.g., Fig. 3B).

[0036] As shown in FIG. 3C, the side portion 120 may be configured to receive the cartridge 140 from above. That is, the cartridge 140 may be pressed into place from, e.g., a point near the head 103 of the spinal implant 100 and retained via a frictional fit or using a cam lock, click-lock feature, or similar mechanical-linking feature. For example, the side portion 120 may include a U-shaped cavity or saddle area, which may be similar to the U-shaped portion of the receiver 110. In some embodiments, the side portion 120 may include additional electronics. For example, the side portion 120 (or receiver 110) may include a strain gauge (or other sensor) 142, e.g., located near the longitudinal member 106 and configured to sense loads associated with the longitudinal member 106. The cartridge 140 may include connectors or adapters 147 to interface with the additional electronics (e.g., strain gauge 142) when the cartridge 140 is received in the U-shaped saddle of the side portion 120. In this way, the cartridge 140 may provide telemetry (e.g., to the external reader 302) that includes sensor data from the strain gauge (or other sensor) 142 of the side portion 120.

[0037] Referring to FIGs. 4A-4B generally, additional embodiments are illustrated. As shown in FIG. 4A, the receiver 110 may include multiple side portions 120, e.g., both left and right side portions (120a, 120b). Components of the electronics systems may be distributed among and/or housed within one or more of the side portions 120 as appropriate. Components such as batteries 144 and antennae 146 (which may be larger, bulkier, and/or occupy a greater volume than other components, such as sensors, circuit boards, microcontrollers, transceivers, and so forth) may be housed in different side portions 120 of the receiver 110, so that no one side portion 120 needs to be large enough to house, e.g., both a battery 144 and antenna 146. Referring to FIG. 4A, the left side portion 120a may house the antenna 146 and the right side portion 120b may house the battery 144, allowing for a more compact (and in this case, symmetric) spinal implant 100.

[0038] As shown in FIG. 4B, the receiver 110 may include a cap portion 150 configured to support electronics components and sensors, e.g., in lieu of (or in addition to) side portions 120. In some embodiments, implant system 100 includes a cap portion 150 that is configured to perform a function of the system 100 that is unrelated to remote sensing. For example, the cap portion 150 may apply a force to the longitudinal member 106 and/or secure the longitudinal member 106 within the receiver 110, similar to the set screw 104 of FIG. 2A. Alternatively or additionally, the system 100 may include a cord or tether secured to one or more vertebra (or other anatomical portion of a patient). In such an embodiment, the cap portion 150 may be configured to provide a clamping force to the cord/tether to maintain the cord/tether in tension. In these and other embodiments, the cap portion 150 may also be configured to house batteries 144, sensors 142, antennae 146, and/or other electronics components in addition to performing the other function of the system 100. In some embodiments, the chief purpose of the cap portion 150 is to house and support electronics component and sensors, e.g., of receivers 110 that lack side portions 120 configured for that purpose. In some examples, the cap portion 150 is a removable modular design of standard dimensions such that it can be installed in selected spinal implant systems 100, e.g., to provide remote sensing capabilities in those systems 100, while leaving other systems 100 without such capability. In some embodiments, The chief purpose of the cap portion 150 is to provide telemetry, either from its own sensors, or from sensors of another smart implant. For example, the pedicle screw 102 (or a component of the pedicle screw 102, such as the set screw 104) may include sensors. In some embodiments, the cap portion 150 is not electrically connected to the sensor of the pedicle screw 102, but it close enough to receive telemetry wirelessly. In this (and other) embodiments, the cap portion 150 may act as a relay device, relaying the telemetry from the pedicle screw 102 to, e.g., an external reader 302.

[0039] Referring to FIG. 4B, a roughly mushroom-shaped cap portion 150 is illustrated. The mushroom-shaped cap portion 150 may be configured to apply a force to the longitudinal member 106 and/or secure the longitudinal member 106 within the receiver 110. Alternatively, a separate component, such as a set screw 104 disposed between the cap portion 150 and the longitudinal member 106 may perform the securing function. The mushroom-shaped cap portion 150 may be configured to have a relatively short profile. As illustrated, the cap portion 150 covers the at least the entire width of the top of the receiver portion 110 and extends at least part of the way along sides of the receiver 110 to provide additional volume, e.g., to house the electronics components. The relatively short profile and overhanging portions of the cap portion 150 may support more voluminous electronics components, such as large batteries 144 and/or antennae 146. In some embodiments, a single battery may be shared between multiple caps 150, allowing each cap 150 to be more compact. In some examples, the receiver 110 includes additional electronics. For example, the receiver 110 may include one or more strain gauges 142, e.g., located near the longitudinal member 106 and configured to sense loads associated with the longitudinal member 106. The cap portion 150 may be configured to receive sensor information (e.g., wirelessly) from the one or more nearby strain gauges 142.

[0040] Referring to FIG. 5A, a spinal implant system 100 may include multiple pedicle screws 102 arranged, e.g., in a spinal fusion construct 160 to stabilize a vertebral segment of one or more vertebrae. The pedicle screws 102 may be connected via one or more longitudinal members 106. As disclosed above, each pedicle screw 102 may be selectively equipped with a sensing system, such as sensing cartridge 140 (not shown). In some examples, additional components may be connected to or otherwise associated with the longitudinal member 106. These additional components may include C-clamps, (e.g., 162a, 162b, 162c), which may secure the ends of straps or tethers that wrap around or are otherwise configured to apply a force to one or more vertebrae.

[0041] As illustrated, in FIG. 5B, a C-clamp 162 is attached to the longitudinal member 106 between two pedicle screws 102, 102a, 102b. In some examples, the C-clamp 162 includes a cord or tether secured to one or more vertebra (or other anatomical portion of a patient). In such an embodiment, the C-clamp 162 may be configured to provide a clamping force to the cord/tether to maintain the cord/tether in tension. FIG. 5B illustrates details of the example C-clamp 162 in side view. In these and other embodiments, the C-clamp 162 may also be configured to house batteries, sensors, antennas, and/or other electronics components and may provide telemetry (e.g., to the external reader 302) related to the tether or the longitudinal member 106, such as strain or temperature measurements. For example, the C-clamp 162 may include a top portion 117 configured to house electronics, similar to the side portion 120 of the pedicle screw 102 disclosed above. In other embodiments, the C-clamp 162 may house electronics in a side portion or other suitable volume within the C-clamp 162. In still other embodiments, the C-clamp 162 may be configured to receive an electronics cartridge 140 (not shown), which may house electronics, battery 144, antennae 146, sensors 142, and so forth, similar to the electronics cartridge 142 disclosed above with respect to the pedicle screw 102. Thus, the spinal implant system 100 may provide telemetry via selectively installed C-clamps, either in addition to or in lieu of telemetry provided by pedicle screws 102 (or other “smart” implants).

[0042] Referring to FIG. 6, a spinal construct 160 including a longitudinal member 106 is shown. As disclosed above, the spinal implant system 100 may provide telemetry via selectively installed C-clamps and/or other “smart” implants, such as pedicle screws and/or cortical screws. As shown in FIG. 6, the longitudinal member 106 itself may also be configured to house batteries 144, antennae 146, sensors 142, and/or other electronics components (e.g., within the longitudinal member 106) and may be configured to provide telemetry related to the longitudinal member 106, such as strain or temperature measurements. In some examples, the longitudinal member 106 may be configured to house an antenna 146 at or near one end and a battery 144 (and associated electronics) at or near the other end. In some examples, the antenna 146 and/or battery 144 may be housed in removable caps which may be attached or secured to one or more ends of the longitudinal member. Similar to the electronics cartridge 140 (and other modular electronics systems) disclosed above, caps may be selectively attached to longitudinal members 106 to provide telemetry related to the longitudinal member 106, in combination with or separate from other sources of telemetry, such as the other smart implants discussed above. In some examples, the longitudinal member 106 houses (or otherwise includes) sensors 142, such as strain gauges (or other force or position sensors) measuring parameters at one or more locations along the longitudinal member 106. For example, the longitudinal member 106 may extend across multiple pedicle screws 102 (and be received within a receiver 110 of one or more of the pedicle screws 102). The longitudinal member 106 may be equipped with sensors to measure forces between the pedicle screw 102 and the longitudinal member 106, e.g., to provide force measurements as telemetry (e.g., to the external reader 302). Alternatively (or additionally), the longitudinal member 106 may be configured to receive and relay measurements from other smart implants, such as digital pedicle screws 102, e.g., to the external reader 302.

[0043] In some embodiments, a spinal implant system 100 includes a first longitudinal member 106a (not shown) that is not equipped to provide telemetry, and a secondary “sensing” longitudinal member 106b (not shown), e.g., installed in parallel with the first longitudinal member 106a. The second longitudinal member 106b may be configured to provide telemetry, either using its own sensors or relaying sensor information from the first longitudinal member 106a and/or other smart implants. In some embodiments, both the first longitudinal member 106a and the second longitudinal member 106b are equipped with sensors and electronics (e.g., housed within removable caps), such that each longitudinal member 106 provides independent telemetry which can be correlated with and/or compared to the telemetry from the other longitudinal member 106 (and/or other smart implants). [0044] Referring generally to FIGs. 7A-7B, a spinal implant system 100 may include one or more interbody cages 108 or other device implanted between vertebrae, e.g., to promote fusion, expand the space between adjacent vertebrae, correct spinal curvature, or for other purposes. In some embodiments, the interbody cage 108 may include sensors, batteries 144, antennae 146 and/or other electronics for providing telemetry. As shown in FIG. 7A, the electronics are built into a removable electronics housing 111 configured to attach to the exterior of the interbody cage 108a. The removable electronics housing 111 may be elastic and configured to fit snugly around the perimeter of the interbody cage 108a. As illustrated, the battery 144 is housed at one end of the electronics housing 111. The antenna 146 may be wound around the perimeter of the interbody cage 108, and may be built into the electronics housing 111. The electronics housing 111 may include one or more sensors, and/or may interface with one or more sensors of the interbody cage 108. Sensors 142 may include force/position sensors, temperature sensors, impedance sensors, and other types of sensors. As shown in FIG. 7B, the electronics housing 111 is attached to the bottom of (e.g., rather than surrounding) the interbody cage 108b. The electronics housing 111 may be a standard modular design having a rigid structure and configured to attach to the interbody cage 108b using a standard connection allowing the electronics housing 111 to attach to different size/shape interbody cages 108. In this way, the electronics housing 111 may be selectively attached to interbody cages 108 to allow telemetry from such interbody cages 108 (e.g., to a remote reader device 302).

[0045] Referring to FIG. 8, a spinal construct 160 is shown which includes and least one interbody cage 108 and pedicle screws 102. Because interbody cages 108 may be further from the patient’s skin (and, thus, further from an external reader 302) than other smart implants, telemetry from sensor-equipped interbody cages 108 may benefit from having their telemetry relayed (e.g., to the external reader 302) by one or more intermediate smart implants. As illustrated, telemetry relay devices may be included in a spinal fusion construct 160. For example, telemetry relay devices may be housed in any or all of the pedicle screw embodiments, C-clamp embodiments, longitudinal-rod embodiments, and/or other embodiments disclosed above. In these and other embodiments, telemetry from the interbody cages 108 is received by the relay device(s) and retransmitted (e.g., to an external reader 302). In this way, the retransmitted telemetry may pass through a smaller amount of signal-attenuating tissues than the original telemetry signal from the interbody cages 108, thus providing a more robust signal to an external reader device 302.

[0046] The invention may be further described by reference to the following numbered clauses:

Clause 1 . An implant system comprising: one or more anchoring members; an electronics system comprising a battery and an antenna; a longitudinal member configured to be secured to at least two of the one or more anchoring members, the longitudinal member comprising one or more electronics housings configured to contain the battery or the antenna of the electronics system; and one or more sensors configured to obtain measurements of a property associated with the longitudinal member, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device.

Clause 2. The implant system of clause 1 , wherein the longitudinal member is configured to contain the antenna and the battery within the longitudinal member.

Clause 3. The implant system of clause 2, wherein the longitudinal member is configured to contain the antenna near a first end of the longitudinal member and to contain the battery near a second end of the longitudinal member.

Clause 4. The implant system of clause 1 , wherein the longitudinal member comprises one or more removable end caps configured to contain the battery or the antenna. Clause 5. The implant system of clause 1 , further comprising a second longitudinal member, configured to be secured to each of the one or more anchoring members.

Clause 6. The implant system of clause 5, wherein the second longitudinal member does not include a sensor.

Clause 7. The implant system of clause 1 , wherein at least one of the one or more electronics housings comprises a C-clamp configured to attach to the longitudinal member.

Clause 8. The implant system of clause 7, wherein the C-clamp is further configured to attach to one or more vertebrae.

Clause 9. The implant system of clause 1 , wherein the one or more sensors comprise an accelerometer, gyroscope, strain gauge, pressure sensor, pH sensor, impedance sensor, optical sensor, or temperature sensor.

Clause 10. An implant system comprising: an electronics system comprising a battery and an antenna; a removable electronics housing configured to contain the battery and/or the antenna of the electronics system; one or more interbody cages configured to receive the removable electronics housing; and one or more sensors configured to obtain measurements of a property associated with the one or more interbody cages, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device.

Clause 1 1 . The implant system of clause 10, wherein the removable electronics housing is configured to fit around a perimeter of at least one of the one or more interbody cages. Clause 12. The implant system of clause 11 , wherein the removable electronics housing is elastic.

Clause 13. The implant system of clause 10, wherein the removable electronics housing is configured to attach to the bottom of at least one of the one or more interbody cages.

Clause 14. The implant system of clause 13, wherein the removable electronics housing is rigid.

Clause 15. The implant system of clause 10, further comprising a spinal construct comprising one or more relay devices configured to receive the transmitted sensor measurements and retransmit the transmitted sensor measurements to an external reader device.

Clause 16. An implant system comprising: an electronics system comprising a battery and an antenna; a removable electronics housing configured to contain the battery and/or the antenna of the electronics system; one or more pedicle screws configured to receive the removable electronics housing; a longitudinal member configured to be secured to at least two of the one or more pedicle screws; and one or more sensors configured to obtain measurements of a property associated with the longitudinal member, wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device.

Clause 17. The implant system of clause 16, wherein the removable electronics housing is configured to engage with a threaded portion of at least one of the one or more pedicle screws.

Clause 18. The implant system of clause 16, wherein: the removable electronics housing is elongate; and the removable electronics housing is oriented such that its longitudinal axis is parallel with the longitudinal axis of the longitudinal member.

Clause 19. The implant system of clause 16, wherein the removable electronics housing is retained via a mechanical-linking feature.

Clause 20. The implant system of clause 16, wherein the removable electronics housing is a threaded cap configured to secure the longitudinal member to at least one of the one or more pedicle screws.

[0047] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. For example, features, functionality, and components from one embodiment may be combined with another embodiment and vice versa unless the context clearly indicates otherwise.

Similarly, features, functionality, and components may be omitted unless the context clearly indicates otherwise. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques).

[0048] The breadth and scope of this disclosure should not be limited by any of the above-described example embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

WHAT IS CLAIMED IS :

1 . An implant system (100) comprising: one or more anchoring members; an electronics system comprising a battery (144) and an antenna (146); a longitudinal member (106) configured to be secured to at least two of the one or more anchoring members, the longitudinal member (106) comprising one or more electronics housings configured to contain the battery (144) or the antenna (146) of the electronics system; and one or more sensors (142) configured to obtain measurements of a property associated with the longitudinal member (106), wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device (302).

2. The implant system (100) of claim 1 , wherein the longitudinal member (106) is configured to contain the antenna (146) within the longitudinal member (106) near a first end of the longitudinal member (106) and to contain the battery (144) within the longitudinal member (106) near a second end of the longitudinal member (106).

3. The implant system (100) of claim 1 , wherein the longitudinal member (106) comprises one or more removable end caps configured to contain the battery (144) or the antenna (146).

4. The implant system (100) of claim 1 , further comprising a second longitudinal member (106b) configured to be secured to each of one or more second anchoring members.

5. The implant system (100) of claim 4, wherein the second longitudinal member (106b) does not include a sensor (142).

6. The implant system (100) of any preceding claim, wherein at least one of the one or more electronics housings comprises a c-clamp (162) configured to attach to the longitudinal member (106).

7. An implant system (100) comprising: an electronics system comprising a battery (144) and an antenna (146); a removable electronics housing (111 ) configured to contain the battery (144) and/or the antenna (146) of the electronics system; one or more interbody cages (108) configured to receive the removable electronics housing (111 ); and one or more sensors (142) configured to obtain measurements of a property associated with the one or more interbody cages (108), wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device (302).

8. The implant system (100) of claim 7, wherein the removable electronics housing (111 ) is configured to fit elastically around a perimeter of at least one of the one or more interbody cages (108).

9. The implant system (100) of claim 7, wherein the removable electronics housing (111 ) is configured to attach to the bottom of at least one of the one or more interbody cages (108).

10. The implant system (100) of any claims 7-9, further comprising a spinal construct (160) comprising one or more relay devices configured to receive the transmitted sensor measurements and retransmit the transmitted sensor measurements to an external reader device (302).

11. An implant system (100) comprising: an electronics system comprising a battery (144) and an antenna (146); a removable electronics housing (111 ) configured to contain the battery (144) and/or the antenna (146) of the electronics system; one or more pedicle screws (102) configured to receive the removable electronics housing (111 ); a longitudinal member (106) configured to be secured to at least two of the one or more pedicle screws (102); and one or more sensors (142) configured to obtain measurements of a property associated with the longitudinal member (106), wherein the electronics system is configured to transmit the obtained sensor measurements to a reader device (302).

12. The implant system (100) of claim 11 , wherein the removable electronics housing (111 ) is configured to engage with a threaded portion of at least one of the one or more pedicle screws (102).

13. The implant system (100) of claim 11 , wherein: the removable electronics housing (111 ) is elongate; and the removable electronics housing (111 ) is oriented such that its longitudinal axis is parallel with the longitudinal axis of the longitudinal member (106).

14. The implant system (100) of claim 13, wherein the removable electronics housing (111 ) is retained via a mechanical-linking feature.

15. The implant system (100) of claim 11 , wherein the removable electronics housing (111 ) is a threaded cap (150) configured to secure the longitudinal member (106) to at least one of the one or more pedicle screws (102).