SMART SURGICAL INSTRUMENT PATCH, INSTRUMENTS, AND METHODS OF APPLICATION

Smart surgical instrument patches, instruments, systems, and methods. The smart surgical instrument patch may include a flexible substrate with electronic components electronically connected to one another. The electronic components may include one or more sensors, a processor, a power source, and a wireless communication unit. The patch may be affixed to an instrument, such as an inserter for installing an expandable implant. During operation of the instrument, the smart surgical instrument patch may provide real time information to the user, such as amount of implant expansion and lordosis profile.

FIELD OF THE INVENTION

The present disclosure relates to instruments for installing surgical devices, such as expandable fusion devices, and smart surgical patches attachable to such instruments for electronically indicating parameters, such as implant expansion and/or lordotic profile.

BACKGROUND

During transforaminal and posterior lumbar interbody fusion procedures, for example, an interbody device may be inserted into the intervertebral disc space between adjacent vertebral bodies. The interbody device may provide indirect decompression to nervous tissue and provide a mechanical foundation for subsequent bone fusion through the disc space. Interbody cages may be static in height or may be inserted at a shortened height and expanded to achieve an increased height in-situ. Due to a narrow surgical working channel, height expansion cannot be directly visualized by the surgeon. As such, the user may rely on intra-operative fluoroscopic images or indicator mechanisms on the implant inserter to know the current expanded height of the expandable implant. Referencing fluoroscopic images only yields approximate and relative height measurements, and mechanism-based indicators can cause instruments to be more complex, expensive, and/or more difficult to sterilize.

Similarly, in robotic and navigated workflows associated with expandable interbody spacers, there is no way to know the height of the interbody as it is expanded. The presence of a robot and/or navigation camera stand may make the space cramped and inconvenient to bring C-arms or other imaging systems into the surgical space, and fluoroscopic imaging only provides an approximate profile measurement. As such, there exists a need for an instrument that electronically indicates the amount of implant expansion in situ or other parameters during the procedure.

SUMMARY

To meet this and other needs, and in view of its purposes, the present application provides electronic sensor patches, instruments for installing expandable implants, systems for communication of implant information to a user, and methods for electronically indicating implant expansion, lordotic profile, or other parameters. The smart sensor patch may include a substrate with a plurality of electronic sensors, a power source, and a wireless communicator.

The sensor patch may be affixed to an instrument, such as an implant inserter, to obtain and send information about the implant, such as expansion height and lordotic angle. One or more of these features may help to provide more accurate information about the implant in situ, reduce the size, mechanical complexity, and cost of the instrument, and/or make the instrument easier to disassemble, clean, and sterilize.

According to one embodiment, a system for obtaining implant information in real time may include a smart electronic patch, an expandable implant, and an instrument for installing the expandable implant. The smart electronic patch may have a substrate with a plurality of electronic components electronically connected to one another. The plurality of electronic components may include a sensor, a processor, a power source, and a wireless transmitter. The expandable implant may be configured to expand in height and/or lordosis. The instrument may have one or more drivers for expanding the implant. As the driver rotates, the sensor on the patch detects movement to obtain raw sensor data, the processor on the patch translates the raw sensor data to implant information, and the wireless transmitter on the patch sends the implant information to a user display.

The system may include one or more of the following features. The sensors may include a plurality of infrared optic sensors. The instrument may include a rod having a distal tip configured to couple to the expandable implant, a proximal tube with a plurality of indicators readable by the sensor, and a handle for turning the one or more drivers. The handle may include an arm with one or more through openings configured to receive the sensor on the patch. The plurality of indicators may include regularly spaced etched lines placed in a radial pattern around the proximal tube. The smart electronic patch may be pre-sterilized and/or pre-charged. The system may further include an external user display configured to receive the implant information from the wireless transmitter and display the information on a screen for a user.

According to another embodiment, a system for obtaining surgical information in real time my include an inserter instrument and a smart electronic patch. The inserter instrument may extend along a central longitudinal axis and may include an outer tube having a distal tip configured to attach to an implant, a pair of drivers positioned through the outer tube for expanding the implant, a clutch collar moveable to control rotation of the drivers, and a handle for turning one or both of the drivers. The smart electronic patch may be affixed to the handle of the inserter instrument. The patch may have a pair of sensors for viewing a plurality of indicators on the outer tube of the instrument, and a third sensor for viewing an indicator on the clutch collar of the instrument. The third sensor may be configured to detect a position of the clutch collar. As the handle rotates, the pair of sensors on the patch may be configured to detect the plurality of indicators on the outer tube.

The system may include one or more of the following features. The clutch collar may include a proximal hub with a plurality of splines and a distal hub with a plurality of splines separated by a flange. The clutch collar may be configured to translate along the central longitudinal axis. The outer tube may define a seat for receiving the distal hub in a forward position and the handle may define a seat for receiving the proximal hub in a rear position. The indicator on the clutch collar may be an etched line around a perimeter of the flange. The plurality of indicators on the outer tube may include regularly spaced alternating etched lines placed in a radial pattern. The pair of sensors may include infrared sensors having an emitter and a receiver that senses reflected infrared light to obtain a signal. As the pair of sensors pass over the alternating etched lines, the signal alternates between high and low, thereby indicating a change in angular position. The pair of sensors may be spaced n*1.5cycles away from one another to interpret direction of movement of the handle.

According to another embodiment, a smart electronic patch includes a flexible substrate and a plurality of electronic components. The flexible substrate may have a top surface and a lower surface with an adhesive. The plurality of electronic components may be affixed to the substrate and electronically connected with one another. The plurality of electronic components may include a plurality of sensors, a processor, a power source, a power regulator, and a wireless communication unit. The plurality of sensors may protrude below the lower surface of the substrate and the processor, power source, power regulator, and wireless communication unit may be positioned on the top surface of the substrate.

The patch may include one or more of the following features. The plurality of sensors may include infrared optic sensors. The flexible substrate may include a plurality of laminated layers. The flexible substrate may be a flexible multi-layer printed circuit board. The power source may be a pre-charged battery. The smart electronic patch may be pre-sterilized, for example, prior to shipment.

According to another embodiment, a method of obtaining real time surgical information may include one or more of the following steps in any suitable order: (1) applying a pre-sterilized and pre-charged smart sensor patch to an instrument, the smart sensor patch having a flexible substrate and a plurality of electronic components, such as a plurality of sensors, a processor, a power source, a power regulator, and a wireless communication unit; (2) during use of the instrument, one or more sensors on the patch detect an input from the instrument (e.g., movement of the handle relative to the outer tube) to obtain raw sensor data, the processor on the patch translates the raw sensor data to real time surgical information, and the wireless transmitter on the patch sends the real time surgical information to a user display (e.g., an external user display). The real time surgical information may include various information about the patch, the instrument, the patient, and/or the operation progress or parameters. By way of example, real time information may be obtained on the amount of expansion and/or lordosis of an expandable implant, stiffness of a patient deformity, amount of instrument movement or articulation, internal stress, torque read-out, etc.

According to yet another embodiment, a method of installing an expandable implant may include one or more of the following steps in any suitable order: (1) providing an inserter instrument with an outer tube having a distal tip configured to attach to an implant, a pair of drivers positioned through the outer tube for expanding the implant, a clutch collar moveable to control rotation of the drivers, and a handle for turning one or both of the drivers; (2) affixing a smart sensor patch to the handle, the smart sensor patch having a flexible substrate and a plurality of electronic components, such as a plurality of sensors, a processor, a power source, a power regulator, and a wireless communication unit; (3) temporarily attaching an expandable implant to the distal tip of the outer tube of the inserter instrument for the procedure;

(4) preparing an intervertebral disc space, for example, including a discectomy; (5) optionally inserting an endoscopic tube into the disc space; (6) introducing the expandable implant into the disc space in a collapsed configuration and seating it in an appropriate position in the intervertebral disc space; (7) expanding the implant in height and/or lordosis into an expanded position and simultaneously receiving real time information from the smart patch, for example, about the amount of expansion and/or lordosis.

Also provided are kits including smart sensor patches including patch packaging, instruments such as inserter instruments for receiving a sensor patch, expandable implants of various types and sizes, and/or other tools and instruments suitable for performing the procedure.

DETAILED DESCRIPTION

Embodiments of the disclosure are generally directed to smart sensor patches, instruments, systems, and methods thereof. Specifically, embodiments are directed to smart sensor patches with one or more sensors configured to provide information, such as implant expansion height and lordotic angle, to the user. The smart sensor patch may be affixed to an inserter assembly configured to install the expandable implant. The sensor patch may be sterile- packed, pre-charged, disposable, and/or wireless. In this manner, the patch does not require a wired connection to transmit data or power, which can cause clutter or hazards in an operating space. Additionally, the patch does not need to be sterilized by the end user or otherwise processed through the sterile processing department (SPD), which makes it more readily available and reduces repeated processing costs.

Sterilizing electronics also has the potential to quickly degrade components and the extreme heat and humidity limits the types of components that can be used. The pre-sterilized and pre-charged patch does not face these issues when the instrument is sterilized and further does not require the end user to buy additional capital equipment to charge, store, and/or sterilize the device. It is also low-profile and is not required to operate the instrument that it is attached to. Thus, if the user does not care to use the patch, they are still able to use the same instrument set without it.

If the patch is used as an alternative to mechanical instrument indication, the system reduces mechanical complexity and cost of the instrument. This can also make the instrument easier to disassemble and clean. The patch is also agnostic to the size of implant, while a mechanical indicator may require a modified design when implants are offered in a variety of heights, lengths, and widths.

Referring now toFIG.1, a smart electronic patch10is shown according to one embodiment. The electronic patch10includes a substrate12supporting a plurality of individual electronic components14. The electronic components14may be electronically connected with one another. For example, the electronic components14may be connected by conductive wires or traces16or other suitable circuitry. The electronic connection may provide for power flow and/or electronic communication or data transfer between the respective components14. The electronic components14may include one or more of the following or other suitable components: one or more sensors18, a processor20, a power source22, a power regulator24, and a wireless communication module or unit26.

The electronic patch10may include a plurality of sensors18. For example, the sensors18may include optical sensors, light sensors, color sensors, proximity sensors, touch sensors, infrared sensors, ultrasonic sensors, etc. In one embodiment, the patch10may include a collection of optic sensors18. The optical sensors18are capable of detecting light at a specific electromagnetic spectra range, such as visible, infrared, or ultraviolet. The sensors18may detect frequency, polarization of light, or wavelength, which change into an electric signal due to the photoelectric effect. In an exemplary embodiment, the patch10includes a collection of three infrared optic sensors18. The infrared optic sensors18may have an emitter and a receiver that senses the reflected infrared light. It will be appreciated that any suitable number and type of sensors may be used.

The electronic patch10may include an on-board computing unit or processor20. The computing unit may include a processor or processing unit with memory, storage, and/or software. The processor20may be configured to receive and process information from the sensors18. In particular, the processor20may translate raw sensor data, for example, corresponding to implant height and lordotic profile. The processor20may then send this information to a user display module28, for example, via the wireless communication component26. The user display module28may be an external device have its own computing unit or processor. Each of the processors may be configured to accept, process, and/or send information related to the patch10, instrument60, implant200, or other device. The on-board processor component20may also be configured to accept user inputs, for example, about the implant type and size, from the display module28or other input device.

The electronic patch10may include a power source22and a power regulator24. The power source22may be an internal battery. The battery22may be alkaline, nickel metal hydride, lithium ion, or other suitable battery type. The battery22may arrive on the patch10fully charged and does not require a wired connection or active charging by the end user prior to use. The power regulator24transforms and distributes power from the power source22to the different electrical components14depending on their needs.

The electronic patch10may include a wireless communication module or unit26, such as a wireless transmitter/receiver. Any information from processor20may be sent wirelessly through the wireless communication unit26or transmitter. The information, such as implant height and lordotic profile, may be projected on a display28, such as a monitor or tablet, after the sensor information is processed by the processor20. In one embodiment, a robotic and/or navigation system may be used to receive and/or send information from the sensor patch10and display the information for the user. Further details of robotic and/or navigational systems can be found, for example, in U.S. Pat. No. 10,675,094, U.S. Pat. No. 9,782,229, and U.S. Patent Publication No. 2017/0239007, which are incorporated herein by reference in their entireties for all purposes.

The electronic components14are electrically connected to one another to achieve their desired functions via one or more wires or traces16or other suitable circuitry. The electronic connection may provide for power flow and/or electronic communication or data transfer between the respective components based on their needs. Although the patch20exemplifies a specific layout with sensors18, processor20, power source22, power regulator24, and wireless transmitter/receiver26, it will be appreciated that any suitable type and number of electronic components14may be arranged together for the desired functionality of the smart patch10. For example, in one alternative embodiment, the wireless transmitter/receiver26may be removed from the patch and a small user display may be provided directly on the instrument itself.

The electronic patch10includes a substrate12for supporting the electrical components14. The electrical components14may be positioned on top of, below, within the substrate12, or at any other suitable location. In one embodiment, the substrate12includes a flexible electronic substrate. The flexible substrate12may be a thin, heat-resistant material formed of plastic or polymers, such as polyimide or polyethylene terephthalate (PET), metal foil, fiberglass, flex glass, or other suitable materials. The substrate12may have an adhesive back configured to adhere the patch10to the instrument or other device. In an exemplary embodiment, the substrate12is a plastic, adhesive printed circuit board (PCB) substrate.

With further emphasis onFIG.2, the substrate12may be composed of multiple layers30,32,34. For example, the substrate12may include a top layer30, one or more mid- layers32, and a bottom layer34. Although three layers are shown, it will be appreciated that the substrate12may have any suitable number of layers. In the case of a printed circuit board

(PCB), the patch10may comprise a single layer PCB, a double layer PCB, or a multilayer PCB. The PCB may include one or more fiberglass layers, copper layers, soldermask layers, silkscreen layers, etc. as will be generally appreciated in the art. The layers30,32,34may be laminated or otherwise joined together. The laminated sandwich structure may include one or more conductive layers, for example, with a pattern of traces16, and insulating layers to achieve the desired functionality. The bottom layer34or an underside thereof may include an adhesive layer, coating, or area configured to secure the patch10to a device, such as the inserter instrument60.

The substrate12may be sized and dimensioned in order to attach to a device, such as the inserter instrument60. For example, the shape of the substrate12may be square, rectangular, polygonal, circular, oval, or of any suitable shape to affix to the instrument. As shown inFIG.1, the patch10may have a front end36, an opposite rear end38, and two sides40,42, connecting the front and rear ends36,38. The sides40,42may taper in width toward the rear end38. The corners may be generally rounded. The patch10may include a top side or upper surface44and a bottom or lower surface46. The lower surface46may have an adhesive coating or layer configured to secure the patch10. The electrical components14may be positioned on the upper surface44, the bottom surface46, or in between the substrate12.

The electronic components14may be arranged around the substrate12in a desired configuration. In the embodiment shown inFIG.1, a pair of sensors18spaced in parallel are located near the front end36and protrude or project below the lower surface46of the patch10. A third sensor18is located more centrally and also protrudes below the lower surface46. The wireless connector26is positioned near the rear end38and is located on the upper surface44of the patch10. The processor20, power source22, and power regulator24are located centrally between the third sensor18and the wireless connector26and are positioned on the upper surface44of the patch10. Although a specific arrangement and configuration of electronic components14are shown, it will be appreciated that the components14may be located and interconnected in any suitable manner.

The smart sensor patch10may be deliverable in a sterile peel-pack with a full battery charge. The pre-sterilized and pre-charged patch10may be shipped flat, for example, or in separate packaging. When ready for use, the pre-sterilized patch10may be configured to flex to conform to the instrument when the adhesive side46is applied to the instrument surface. Before use, the connection for the power source22to the rest of the circuit may be interrupted by a plastic strip. When ready for use, the user removes the plastic interrupter strip after opening the package, which begins the flow of power. The pre-sterilized, pre-charged patch10may be configured to last long enough for a single use or case. Following the surgical case, the patch10may be thrown away.

Turning now toFIG.3, an inserter instrument60is shown according to one embodiment. The inserter instrument60is configured to install an expandable implant200, for example, as shown inFIGS.4A-4C. The inserter60includes a threaded rod61and rigid tube62that hold the implant to the instrument60, two independent drivers64,66that drive the anterior and posterior height of the implant, a clutch collar68that is translated forward and backward to control engagement with either a single driver or both drivers64,66, and a driver handle70that engages with the back of either one or both drivers64,66depending on the position of the clutch collar68. The distal engagement of these two drivers64,66with an implant, such as implant200, as well as implant expansion from the combination of drivers is described in more detail in U.S. patent application Ser. No. 17/540,381, which is incorporated by reference herein in its entirety for all purposes.

As shown inFIGS.4A-4C, the expandable interbody implant200may include an upper endplate212, a lower endplate214, an upper deployable spike216, and a lower deployable spike218. The upper and lower spikes216,218may be deployed by a sidecar assembly232, which may include a sidecar carrier234configured to move an upper carrier endplate236coupled to upper anchor or spike216and a lower carrier endplate240coupled to lower anchor or spike218. The main upper and lower endplates212,214and upper and lower carrier endplates236,240are configured to be expanded by an actuator assembly220, which may include a front ramp222, a middle ramp224, and a rear ramp226moveable via an actuator or central drive screw228and an outer drive screw or nut230. The anterior and posterior heights of the implant200may be independently adjustable for continuous adjustment of height and lordotic profile. More details of implant200are described in U.S. patent application Ser. No. 17/540,381, which is incorporated by reference herein in its entirety for all purposes. Although implant200is exemplified herein, it will be appreciated that any suitable implant or device may be used in connection with the instruments and electronic patches described herein.

The inserter instrument60extends from a proximal end72to a distal end74along a central longitudinal axis L. The threaded rod61and rigid tube62may form a hollow outer tube or cannula defining a central channel therethrough. The threaded rod61extends from the rigid tube62to the distal end74, thereby forming a distal tip for engagement with the implant200. The proximal rigid tube62may define a recess or seat for receiving a portion of the clutch collar68when in the forward position. The first outer driver64is positionable through the outer tube62and rod61such that its tip is configured to engage with and rotate the drive nut230on the implant200. The outer driver64is cannulated such that the second inner driver66is positionable through the outer driver64. In this manner, the inner and outer drivers64,66are coaxial about central longitudinal axis L. The tip of the inner driver66is configured to engage with and rotate the central drive screw228of the implant200. The proximal end78of the inner driver66is attachable to the handle70, for example, via a threaded connection or other suitable interface.

The clutch collar68is moveable to control engagement with the drivers64,66. In particular, the clutch collar68is configured to translate up and down the instrument60along the longitudinal axis L to engage with the handle70or the outer tube62, respectively. The clutch collar68includes a proximal hub80and a distal hub82separated by a flange84. The proximal hub80may be in the form of a round gear with a plurality of teeth or splines86around the perimeter of the proximal hub80. The splines86may be uniformly distributed around the outer body of the proximal hub80. Similarly, the distal hub82may include a round gear having a plurality of teeth or splines88around the perimeter of the distal hub82. The flange84divides the clutch collar68and forms a radial ring separating the hubs80,82. A marker90, such as an etched line or ring, may be provided around a lip or periphery of the flange86. Depending on the position of the clutch collar68, the proximal hub80is receivable in a seat in the handle70or the distal hub82is receivable in a seat in the proximal end of the outer tube62.

With further emphasis onFIGS.5A-5B, movement of the clutch collar68is shown. The clutch collar68may be linearly translated along longitudinal axis L between a front position and a rear position.FIG.5Ashows the clutch68in the front or forward position andFIG.5Bshows the clutch68in a back or rear position. The inner driver66is always engaged with the driver handle70. The clutch collar68is rotationally locked with the outer driver64. In the rear position as shown inFIG.5B, the splines86on the clutch collar68engage with internal splines on the driver handle70, such that they are rotationally locked. In this way, with the clutch collar68in the rear position, both the inner and outer drivers64,66rotate at the same rate. When the clutch collar68is in the forward position as shown inFIG.5A, the splines88on the collar68engage with internal splines on the rigid tube62, such that they are rotationally locked, and the splines86on the proximal hub80that were engaged with the driver handle70are unengaged. In this way, when the clutch collar68is forward, the driver handle70only turns the inner driver64, and the splines88on the rigid tube62prevent the outer driver66from being turned.

The handle70includes a base92with a recess or inner seat configured to receive the proximal hub80in the rear position (as shown inFIG.5B). A palm handle94connects to the base92, for example, with a stem. The palm handle94may be rotated by a user to apply a torque to the respective driver64,66. An arm96extends distally and overhangs the base92of the handle70. The arm96includes a free distal end98, an upper face102, and an opposite lower face. The upper face102may defines an optional recess104configured to receive the smart patch10. The recess104may be sized and dimensioned to be substantially the same size or slightly larger than the outer dimensions of the patch10.

As best seen inFIGS.6A-6B, the arm96of the handle70defines one or more through openings106configured to align with or receive the sensors18from the smart patch10.FIG.6Ashows the driver handle70with the sensor-accepting openings106before the patch10is applied, andFIG.6Bshows the patch10affixed to the arm96of the handle70with the sensors18seated in the openings106. The openings106may extend from the upper face102through to the lower face of the arm96, thereby providing a line of sight to the inner components of the instrument60(e.g., the rigid outer tube62and moveable clutch collar68). In particular, a pair of openings106may be positioned near the free end98of the arm96and a third opening106may be located centrally and more proximally, which mimics the sensor placement on the patch10.

The three infrared optic sensors18on the patch10may be positioned such that they line up with the accepting openings106through the arm96of the inserter driver handle70. In particular, the distal pair of openings106may be configured to receive patch sensors18that view one or more indicators108on the proximal end of the outer tube62. The indicators108on the outer tube62may include a pattern of dots, lines, or other markings. The pattern may form an alternating and repeating pattern around the outer tube62. In one embodiment, the outer tube62has regularly spaced etched lines108placed in a radial pattern. The openings106in the arm96of the driver handle70may be sized and dimensioned to accept the infrared or other optical sensors18such that two of the distal-most sensors18lie in the same plane as the etched line pattern108. For example, the sensors18may be spaced apart by a multiple of1.5times the etched pattern spacing. This method of spacing sensors18may be useful with direction-detecting rotary encoders, and the sensor processing is described in more detail herein with regard toFIGS.8A-8C.

The placement of the pair of distal sensors18on arm96of handle70and corresponding indicators108on stationary outer tube62provides the data input to the sensors18corresponding to the rotational movement of the drivers64,66. As the handle70is rotated to drive one or both of drivers64,66, the arm96of the handle70simultaneously rotates about the central longitudinal axis L. As the pair of distal sensors18in the arm96, pass over the repeating pattern of indicators108on the outer tube62, the sensors18are able to determine the change in angular position in real time. Although this embodiment exemplifies a rotating arm and handle assembly passing over a stationary outer tube with etched markings, it will be appreciated that the positioning could be reversed or reconfigured, for example, with the patch and sensors placed on the stationary tube and the markings or indicators on a moveable component.

The third opening106may be configured to receive third patch sensor18that is able to view indicator90on the flange84when the clutch collar68is in the rear-most position (as shown inFIG.5B). In particular, the arm96of the driver handle70has a third sensor- accepting opening106that aligns with the clutch collar68, such that the sensor18can detect the presence or absence of the collar68due to the etched line90that appears circumferentially around the widened lip of the flange84. When the clutch collar68is in the forward-most position (as shown inFIG.5A), the etched line90is not visible to third sensor18and the driver handle70only turns the inner driver64. When the clutch collar68is in the rear position (as shown inFIG.5B), the etched line90is visible to the third sensor18and both the inner and outer drivers64,66rotate at the same rate.

Turning now toFIG.7, a flowchart110shows the system of electronics information flow including the data, power, and mechanical interactions between the system components according to one embodiment. In the embodiment shown, electronic patch10includes sensors B1, B2, B3, processor20, power source22, power regulator24, and wireless communication module26. Inserter60includes driver handle70, radial etched lines108on the rigid inserter tube62, and single etched edge90on the clutch collar68. As the user operates the instrument60, information about the instrument60and the implant200is provided to the user on the user display hub or user display/feedback unit28. Sensors B1, B2view the etched lines108on the outer tube62and sensor B3views the etched line90on the clutch collar68, and relay the information to the on-board processor20. The processor20translates the raw sensor data to implant height and lordotic profile, for example, and sends this information to the user display module28via the wireless communication module26. The power source22provides power and the regulator22transforms and distributes power to the different electronic components14.

Alternatively, the division of tasks between the on-board processor20and the processor associated with the user display hub28may be reconfigured. For example, the wireless control unit26on the patch10may be configured to only transmit raw sensor data, and the processor on the user display hub28may take on the responsibility of processing the data, for example, based on implant selection. This allows the patch10to have lower power and processing requirements.

With further emphasis onFIGS.8A-8C, in the case of infrared optical sensors18, the sensor information from sensors18may be read or decoded using one of the following methods.FIG.8Ashows a simplified diagram of regularly spaced shaded/etched regions and sensor displacement of n*1.5 cycles.FIG.8Bshows signal reading in case of clockwise rotation as sensor A value changes to match that of sensor B.FIG.8Cshows signal reading in case of counterclockwise rotation as sensor A value changes to be opposite of sensor B value.

The patch10may use the following framework for direction-detecting rotary encoders. All of the infrared sensors18may have an emitter and a receiver that senses the reflected infrared light. As the B1and B2sensors pass over the alternating etched lines108, the signal alternates between high and low, and the changing signal indicates change in angular position. The second sensor18, which is spaced n*1.5 cycles away, helps to interpret direction of movement based on whether the second sensor's value changes to the same or different value from that of the first sensor18.

The width of the etched stripes108dictates the fidelity of the angular position read-out. The way that this displacement translates to implant height depends on the pitch of the threaded actuator228and the relative angles of the ramps222,224,226within the implant200. The user will select an implant size and variety on the user display hub28, and this information may be transmitted to the processor20through the wireless communication unit26so that accurate implant profile information can be calculated. As the user slides the clutch collar68back and forth, sensor B3will detect the collar position, which will inform implant status in cases where the implant has two independent driven components that are engaged and unengaged with the collar68.

This calculated implant profile will be fed back to the wireless communication unit26, which will transmit it to the user display unit28. The user display unit28may be a standalone unit or may take the form of pre-existing robotic and/or navigation platforms. The user display unit28may display qualitative feedback such as anterior and posterior heights of the implant or lordotic profile. This information may also be translated into a graphic, such that the user can visualize the implant expanding.

Although the described embodiment exemplifies that the sensors detect implant expansion or lordotic profile, it can be appreciated that with different sensors and placement on various instruments, other parameters may be communicated to a user with a similar patch. For example, instrument information, such as instrument articulation and internal stress experienced by an instrument, may be determined. In one alternative embodiment, the sensors18may include strain gauges. Using different sensors18, such as strain gauges, arranged on different instruments may provide different values to the user. For example, the patch10with a strain gauge placed along deformity-manipulation tools may give the user feedback about the stiffness of the deformity. The patch10with a strain gauge placed transversely around a driver shaft may give torque read-out information, potentially supplementing or substituting mechanical torque limiters. It will be appreciated that the sensors18may be used to obtain different types of information about the patch10, the instrument60, the implant200, or other devices or instruments.

Advantageously, the patches, instruments, and implant systems and associated devices described herein can be used to provide valuable information to the user in real time. For example, the smart sensor patch may be affixed to an inserter instrument, which installs expandable implants. The patch may come pre-sterilized and pre-charged, for example, ready for a single surgical use. In this manner, the end user is not required to sterilize or charge the patch for use. As the implant is expanded in situ, the sensor patch obtains information, such as implant height and lordotic profile, from the inserter instrument and relays this information to the user in real time.

It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the claims. One skilled in the art will appreciate that the embodiments discussed above are non-limiting. It will also be appreciated that one or more features of one embodiment may be partially or fully incorporated into one or more other embodiments described herein.