Stemless orthopedic implant with a sensor

Abstract

The humeral joint forming system includes a sensor device, a first portion (462) of this circuit and a humeral head (402) including an adapter socket (412), a tapered adapter (406) installed inside the adapter socket, a stainless humeral anchor (404) connectable thereto, and a second portion (460 / 464 / 490A / 490B / 540B) of the circuit extending into the adapter socket. The tapered adapter and the stainless humeral anchor include a central bore (424 / 436) extending therethrough, and the second portion is connected to the first portion by an electric circuit (464 / 490A / 490B) extending through the tapered adapter. The humeral head includes a ceramic material, the second portion includes a force sensor (540B / 558A / 558B / 608) extending into the adapter socket, and the tapered adapter engages with the force sensor when installed in the adapter socket.

Description

Technical Field

[0001] (Claim of Priority) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 359,492, filed Jul. 8, 2022, and U.S. Provisional Patent Application No. 63 / 423,957, filed Nov. 9, 2022, the benefit of the priority of each of which is claimed herein and each of which is incorporated herein by reference.

[0002] The present disclosure is generally, but not limited to, systems, devices, and methods incorporating sensors for use in performing, monitoring, and evaluating medical procedures, such as arthroplasty procedures. More specifically, but not limited to, the present disclosure is directed to orthopedic and prosthetic implants incorporating sensors.

Background Art

[0003] Arthroplasty procedures involve the implantation of medical devices, such as orthopedic and prosthetic implants, into a patient's anatomy. Typically, it is difficult to obtain feedback regarding the effectiveness of an implant or an implant procedure once, or even during, the implant has been implanted into the patient's body. Attempts have been made to obtain data from orthopedic implants using sensors.

[0004] There is Patent Document 1 titled "Devices, Systems, and Methods for Monitoring Using Medical Devices" by Hunter et al.

[0005] There is Patent Document 2 titled "Implantable Reporting Processor for Implants" by Bailey et al.

[0006] There is Patent Document 3 titled "Devices, Systems, and Methods for Monitoring Using Medical Devices" by Hunter et al.

Prior Art Documents

Patent Documents

[0007] [Patent Document 1] U.S. Patent Application Publication No. 2018 / 0125365 [Patent Document 2] U.S. Patent Application Publication No. 2019 / 0350518 [Patent Document 3] U.S. Patent No. 10,492,686 [Summary of the Invention] [Problems to be Solved by the Invention]

[0008] The inventors recognized that problems to be solved by conventional sensor systems used in conjunction with implantable medical devices such as orthopedic prosthetic devices involve the need to incorporate the sensor system within the envelope of existing prosthetic device designs. For example, the sensor system includes a battery and electronic devices that must be housed within the prosthetic device to be implanted. Thus, the prosthetic device not only has to be large enough to accommodate the battery and electronic devices, but the battery and electronic devices have to conform to the form factor of the prosthetic device. Redesigning the prosthetic device to include the battery and electronic devices can increase the size of the prosthetic device, and as a result, may require removing extra bone from the patient to accommodate the larger prosthetic device.

[0009] The inventors further recognized that there are problems associated with incorporating an electronic device module within a stemless prosthetic device. For example, many prosthetic devices use a stem that can be inserted into bone material to immobilize the prosthetic device and facilitate attachment to bone. The stem can include an elongated body that can be inserted deep into cancellous bone material, which enables the stem and thus the prosthetic device to be held tightly against the bone. The stem provides a body having a large volume in which electronic components can be assembled. However, the use of the stem can sometimes be disadvantageous in that the stem can displace healthy cancellous bone and pose a structural risk to the cortical bone surrounding the cancellous bone. For example, sometimes driving a stem, which can be made of a hard material such as stainless steel, titanium alloy, or cobalt chrome, into cancellous bone using a hammer or mallet can cause stress and fracture to the cortical bone. Accordingly, it is desirable to use a prosthetic device having stemless fixation. However, stemless fixation systems do not include components having a large volume that can be used to house electronic device components or a power source. Thus, the inventors recognized that while many stemless anchor prostheses are desired to have a small bone material footprint to minimize impact on the biological structure, they simultaneously undesirably reduce the available space on the prosthetic device for including electronic device components to an unacceptable extent.

[0010] The inventors also recognized that there are problems in transmitting data from implanted sensors from the prosthetic device. Prosthetic orthopedic implants are typically mainly made of metal structurally, which makes wireless signal transmission difficult or impossible. Thus, in addition to the problems described above, the following subject matter addresses the problem of data transmission through the use of a multi-component sensor device.

[0011] The inventors have also recognized that it can be difficult to determine during surgery whether a prosthetic implant for orthopedic surgery meshes properly during assembly. It can be difficult to determine whether a prosthetic head component is properly assembled relative to an anchor component. The surgeon may need to remove and reattach a number of prosthetic head components during surgery to find proper joint tension and the like. Each time, tissue and blood can interfere with the assembly process and obstruct visibility. The inventors have recognized that intraoperative sensor data collection was not available, at least in part, due to the lack of sensing capabilities within prosthetic implants as described above.

Means for Solving the Problems

[0012] The present subject matter can provide solutions to these and other problems, such as, for example, in a sensor-enabled prosthetic implant that can have an electronic device module separated into different components connected by electrical leads, where each component can be positioned at different parts or locations of the prosthetic device. Conventional sensor modules typically include only a single housing, and thus, prosthetic devices are required to have a large space to accommodate a housing for the entire electronic device module. In the present disclosure, the electronic device module can be separated into different elements such as a battery, a circuit, an antenna, etc. The different elements can be positioned at different locations of the prosthetic device, such as, for example, a connecting component, an adapter component, an anchor component, etc. In this way, various elements of the electronic device module can be positioned in a more advantageous manner, such as, for example, by positioning a sensor element closer to a desired sensing location and positioning an antenna element at a location suitable for wireless signal transmission, such as further away from a metallic component of the prosthetic device.

[0013] The present subject matter can provide solutions to these and other problems by providing a prosthetic humeral head component that can be manufactured from materials that facilitate the transmission of electronic and wireless communication signals internally. For example, electronic signals, such as electrical currents, can communicate through conductive materials such as stainless steel, cobalt-chromium alloys, and titanium. In an embodiment, wireless communication signals, such as radio waves, can be transmitted through a non-blocking material such as a ceramic. In an embodiment, the humeral head component can be made of a composite material or compound.

[0014] The present subject matter can provide solutions to these and other problems by providing a prosthetic humeral head component that includes sensors that can provide intraoperative and postoperative feedback. In an embodiment, such feedback can include force feedback, contact feedback, motion feedback, and the like.

[0015] 1) The present subject matter includes the use of a sensor-enabled implantable prosthetic device that can conform to the form factor of existing designs.

[0016] 2) The present subject matter includes the use of a sensor-enabled implantable prosthetic device that can be used with a stainless prosthetic device that does not have a large amount of internal space for housing electronic equipment modules.

[0017] 3) The present subject matter includes the use of a sensor-enabled implantable prosthetic device that can allow for more advantageous positioning of various electronic components.

[0018] 4) The present subject matter includes the use of a prosthetic component manufactured from materials that facilitate the transmission of electronic and wireless signals.

[0019] 5) The present subject matter includes a sensor-enabled implantable prosthetic device that can provide feedback regarding the coupling of various components of a prosthetic device.

[0020] In one embodiment, the humeral arthroplasty system includes a sensor device, a first portion of the circuitry of the sensor device, and a humeral head including an adapter socket, a tapered adapter configured to be installed inside the adapter socket, a stainless steel humeral anchor connectable to the tapered adapter, and a second portion of the circuitry of the sensor device extending into the adapter socket. In another embodiment, the tapered adapter and the stainless steel humeral anchor can include a central bore extending therethrough, and the second portion of the circuitry of the sensor device can be connected to the first portion by an electrical circuit extending through the tapered adapter. In another embodiment, the humeral head can include a ceramic material. The second portion of the circuitry can include a force sensor extending into the adapter socket, where the tapered adapter is configured to engage the force sensor when installed in the adapter socket.

Brief Description of the Drawings

[0021]

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[0022] FIG. 1A illustrates a surgical system 100 for surgery on a surgical site 105 of a patient 110 according to at least one embodiment of the present disclosure. In an embodiment, the surgical site 105 can include a joint including one or more bones. The surgical site 105 can include any surgical site of the patient 110 including, but not limited to, the shoulder, head, elbow, waist, ankle, thumb, spine, and the like. The surgical system 100 can similarly include a robotic system 115 with one or more robotic arms, such as robotic arm 120. As illustrated, the robotic system 115 can use only a single robotic arm. The robotic arm 120 can be a six-degree-of-freedom (DOF) robotic arm, such as the ROSA® robot manufactured by Medtech, a company of Zimmer Biomet Holding, Inc. In some embodiments, the robotic arm 120 can be collaboratively controlled by a surgeon's input on a surgical instrument or end effector, such as surgical instrument 125. In other embodiments, the robotic arm 120 can operate autonomously. Although not illustrated in FIG. 1A, one or more positionable surgical support arms can be incorporated into the surgical system 100 to assist in positioning and stabilizing instruments or biological structures during various procedures.

[0023] Each robotic arm 120 can rotate in the axial and radial directions and can accommodate a surgical instrument 125 or an end effector at its distal end 130. The surgical instrument 125 can be any surgical instrument adapted for use by the robotic system 115, including, for example, a guide tube, a holding device such as a holder device, a grasping device such as a pen grip, a deburring device, a reaming device, an impacter device such as a humeral head impacter, a pointer, a force limiting device, a probe, and the like. The surgical instrument 125 can be positioned by a robotic arm 120 that can include a number of robotic joints such as joint 135 to enable positioning of the surgical instrument 125 adjacent to or at any desired location within a given surgical area 105. The robotic arm 120 can be used with an instrument positioning device such as an instrument holder to position the instrument in a known, desired, or predetermined orientation relative to the surgical area 105 based on a virtual coordinate system determined by the computer system 140.

[0024] The robotic system 115 can similarly include a computer system 140 capable of operating the robotic arm 120 and the surgical instrument 125. The computer system 140 can include at least a memory, a processing unit, a user input device, an output device, a communication device, and the like. The computer system 140 and the tracking system 165 can similarly include a human interface device 145 for providing images to the surgeon for use during the surgical procedure. Although the computer system 140 is illustrated as a separate stand-alone system, in some embodiments, the computer system 140 can be integrated with the robotic system 115. The human interface device 145 can provide images including, but not limited to, three-dimensional images of bones, joint sockets, joints, prostheses, etc., as well as bone density information for the patient's overall bone and specific bones. The human interface device 145 can include an associated input mechanism such as a touch screen, a foot pedal, or other input human interface device compatible with the surgical environment.

[0025] The computer system 140 can receive pre-operative, intra-operative, and post-operative medical images. These images can be received in any way, and the images can include, but are not limited to, computerized tomography (CT) scans, magnetic resonance imaging (MRI), two-dimensional X-rays, three-dimensional X-rays, ultrasonic images, and the like. As discussed herein, these images can include, or can be modified to include, bone density information that can be used, for example, to generate a three-dimensional model of a particular patient's biological structure that can indicate three-dimensional bone density. In an example, the images and the three-dimensional bone density model can be sent via a server as a file attached to an email. In another example, the images can be stored on an external memory device such as a memory stick, coupled to a USB port of the robotic system, and uploaded into the processing unit. In yet another example, the computer system 140 can access the images over a network from a remote memory device or service.

[0026] After receiving one or more images, computer system 140 can generate one or more virtual models related to surgical region 105, such as a three-dimensional model incorporating bone density or biostructure information, for example. Alternatively, computer system 140 can receive a virtual model of the patient's biostructure prepared remotely. Specifically, a virtual model of the patient 110's biostructure can be created by defining anatomical points within the images and / or fitting a statistical anatomical model to the image data. In an embodiment, the virtual model can include a finite element model. Additionally, a virtual model can be created using a number of orthogonal x-ray images of the patient's biostructure merged together to form a three-dimensional model. The virtual model can be used for calculations related to the desired height, depth, tilt angle, or twist angle of implants, stems, surgical instruments, etc., associated with being used within surgical region 105, along with a virtual representation of the implant. In another type of procedure, the virtual model can be used to determine the insertion location, trajectory, insertion force (e.g., the upper limit of the insertion force to avoid adverse effects on a particular patient's bone structure), and depth for insertion of an instrument. The virtual model can similarly be used to determine bone dimensions, implant dimensions, bone fragment dimensions, bone fragment arrangement, etc. Any generated model, including the three-dimensional model, can be displayed on human interface device 145 for reference during surgery, or robot system 115 can be used to determine the movement, action, and operation of robotic arm 120 or surgical instrument 125. Known techniques for creating virtual bone models, such as those discussed in U.S. Patent No. 9,675,461, titled "Deformable Articulating Template," by Makfouz, or in U.S. Patent No. 8,884,618, titled "Method for Generating a Patient-Specific Bone Shell," as well as other techniques known in the art, can be used.

[0027] The virtual model and the three-dimensional model can include patient-specific information such as, for example, age, gender, ethnicity, height, weight, activity level, etc. Using the patient-specific three-dimensional bone model, for example, 1) determining various prostheses that fit the biological structure such as the soft tissue biological structure including the bone density information of the imaged patient, 2) determining the location for performing bone modification for the purpose of preparing the bone to accommodate a prosthetic device corresponding to the density of the bone substance, 3) determining the fit and fixation of the patient's bone substance and the selected prosthesis based on the density of the bone substance, and 4) determining the postoperative results for the selected parameters of 1) to 3) based on, for example, a specific activity of the imaged patient.

[0028] Computer system 140 can similarly communicate with a tracking system 165 that can be operated by computer system 140 as a stand-alone unit. Surgical system 100 can use a Polaris optical tracking system manufactured by Northern Digital, Inc. of Waterloo, Ontario, Canada. Further, tracking system 165 can include a tracking system illustrated and described in U.S. Patent Application Publication No. 2017 / 032035, titled "Surgical System with Assisted Navigation" by Brian M. May, which is hereby incorporated by reference in its entirety. Tracking system 165 can monitor a plurality of tracking elements, such as tracking element 170, attached to the object in question, to track the location of a number of objects within the surgical field. Tracking system 165 functions to create a virtual three-dimensional coordinate system within the surgical field to track each part of the patient's anatomy, surgical instrument, or robotic system 115. Tracking element 170 can be a tracking frame including a number of infrared reflective tracking spheres or a similar optically tracked marker device. In one embodiment, tracking element 170 can be placed on or adjacent to one or more bones of patient 110. In other embodiments, tracking element 170 can be placed on robotic arm 120, surgical instrument 125, and / or an implant to accurately track the position within the virtual coordinate system associated with surgical system 100. In each case, tracking element 170 can provide position data, such as the position of the patient, bone, joint, robotic arm, implant, and the like.

[0029] The robotic system 115 can include various additional sensors and guiding devices. For example, the robotic system 115 can include one or more force sensors, such as force sensor 180. The force sensor 180 can provide additional force data or information to the computer system 140 of the robotic system 115. The force sensor 180 can be used for a surgeon to collaboratively move the robotic arm 120. For example, the force sensor 180 can be used to monitor the impact force or implantation force during certain surgeries, such as the insertion of an implant stem into the intramedullary canal. Monitoring the force can assist in preventing negative results through the force-fitting components. In other embodiments, the force sensor 180 can provide information about the tension of soft tissue within the tissue surrounding the target joint. In some embodiments, the robotic system 115 can similarly include a laser pointer 185 that can generate a laser beam or array used for implant alignment during a surgical procedure.

[0030] For the purpose of ensuring that the computer system 140 moves the robotic arm 120 in a fixed relationship known to the surgical area 105 and the patient 110, the spaces of the surgical area 105 and the patient 110 can be registered with the computer system 140 via a registration process involving registering the fiducial markers attached to the patient 110 together with the corresponding images of the markers within the patient 110's body recorded preoperatively or immediately prior to the surgical procedure. For example, a plurality of fiducial markers can be attached to the patient 110, an image of the patient 110 with the fiducial markers can be taken or acquired, and stored in the memory device of the computer system 140. Thereafter, if the patient is not already there for imaging, the patient 110 with the fiducial markers can be moved into the surgical area 105, and the robotic arm 120 can contact each of the fiducial markers. The engagement of each fiducial marker can be cross-referenced or matched with the location of the same fiducial marker in the image. In an additional embodiment, the patient 110 and the medical image of the patient can be registered in real space using a non-contact method, such as by using a surface registration algorithm that can align the surface of the patient derived from the scanning of a laser range finder and the laser range finder held by the robotic arm 120 with the surface of the patient in the medical image. Thus, the real-world three-dimensional geometry of the biological structure attached to the fiducial marker can be correlated with the biological structure in the image, and the movement of the instrument 125 attached to the robotic arm 120 based on the image will occur correspondingly within the surgical area 105.

[0031] Thereafter, for implanting the selected prosthesis according to the selected surgical plan, the other instruments and devices attached to the surgical system 100 can be positioned by the robotic arm 120 in a desired orientation known to the biological structure. The location where the robotic arm 120 holds the instrument and the accompanying resection or bone modification is placed on the bone can be planned using patient-specific soft tissue information.

[0032] Surgical system 100, and in particular computer system 140, can be used to provide preoperative and intraoperative feedback regarding the fixation of implants into bone material based on the various electronic devices and sensors described herein. The feedback can include insertion force, acceleration data, and other sensor data that can be analyzed and evaluated, for example, to determine the implantation, insertion, proper installation, etc. of the prosthetic device. The insertion force can be compared to threshold insertion force data stored within a controller or elsewhere that correlates the insertion force to the proper installation or assembly of the prosthetic device. The feedback can similarly provide postoperative feedback to provide data regarding the patient's activity and use of the implanted prosthetic device. Such postoperative data can include pressure, force, strain, pH, temperature, acceleration, etc. The feedback can be provided to an external interrogation device and can take the form of visual indicators such as heat maps, risk scales, color coding, etc. to provide information to the surgical team regarding the specific risks of a particular patient. Additionally, the feedback can include individual recommendations such as go / no-go or go recommendations for a specifically planned implant scenario. In an example, the feedback can be compared to a historical dataset collected from procedures performed on similar patients. In an example, the feedback can be linked to a dataset from the application of other techniques along a patient's continuum of care. For example, feedback and data from multiple sensors, including the sensors of the present disclosure, can be compared to software-based preoperative planning and intraoperative data, such as positioning data, from a robotic surgical system to provide the surgeon with information regarding which implant designs, sizes, and surgical approaches produce favorable clinical outcomes for individual and future patients.

[0033] Figure 1B is a schematic diagram illustrating a total shoulder arthroplasty with sensors embedded within a prosthesis, according to some exemplary embodiments. The total shoulder arthroplasty system 500 includes a glenoid component 515 affixed to the scapula 505, the glenoid component including an implantable sensor 540A. On the humerus side, the total shoulder arthroplasty system 500 includes a humeral prosthesis 525 affixed within the humerus 520 that includes an implantable sensor 540B. Optionally, the implantable sensors can be placed within a component or a removable module. In some embodiments, the sensors are integrated within the components. In one example, sensors such as the implantable sensors 540A, 540B communicate data wirelessly to a computer device, which then analyzes the data to provide feedback to the surgeon. In another example, a first of the implantable sensors 540A and 540B can communicate data to a second of the implantable sensors 540A and 540B, while the second implantable sensor then communicates the data wirelessly to a computer device. For example, relative position data between the implantable sensors 540A and 540B (and vice versa) can be transmitted to the computer device to indicate how that position data changes over time. In an example, the sensors 540A, 540B can include force sensors and can be configured to receive forces transmitted between the glenoid component 515 and the humeral prosthesis 525, for example, to check the joint tension when the shoulder is reduced with the prosthesis in place at a given location or during and after the patient's recovery post-surgery. Such data can be correlated to clinical outcomes such as acromial stress fractures or dislocations to determine, for example, optimal joint tension. In some examples, a single implantable force sensor such as the implantable sensor 540A is used to provide accurate force data for the joint. In other examples, multiple force sensors are implanted within different parts of the prosthesis to provide additional information about the load pattern within the joint. For example, the force sensors can be implanted around the glenoid or the humeral head component, thus enabling force mapping over different parts of the implantable components as well as over the full range of motion.It is contemplated that an embedded force sensor pair can also be used to measure the range of motion and to measure wear of components such as polymer bearings. As discussed herein, sensors 540A and 540B can be composed of a plurality of sub-components that can be assembled to different parts of the glenoid component 515 and the humeral prosthesis 525, respectively. An example of the humeral prosthesis 525 is discussed with reference to FIGS. 2A through 9. In an example, the total shoulder arthroplasty system 500 can include a device as described in U.S. Patent No. 10,966,788, entitled "Sensor-Based Shoulder System and Method," by Orsa Britton et al., the contents of which are incorporated herein by reference.

[0034] FIG. 2A is a perspective view of an excised humeral head of the humerus with an implanted humeral arthroplasty prosthesis 200 therein. FIG. 2B is a side view of the humeral arthroplasty prosthesis 200 of FIG. 2A showing the humeral head prosthesis 202 and the stainless steel humeral anchor prosthesis 204. FIGS. 2A and 2B are discussed simultaneously.

[0035] The stainless steel humeral anchor prosthesis 204 of the humeral arthroplasty prosthesis 200 can be implanted into the humerus 210. The humerus 210 can include a humeral head 212 (FIG. 2A), a tuberosity region 215, and a diaphyseal region 216 (FIG. 2A). The humerus 210 can have a hard outer formed of cortical bone 218 and a softer inner formed of cancellous bone 220. A cut surface 214 can be formed by excising the humeral head 212 to expose the cancellous bone 220. Although this application is discussed with respect to the bones of the shoulder joint, the disclosed systems, devices, and methods can be used in conjunction with other bones and joints such as the ankle, knee, and hip joints.

[0036] The stemless humeral anchor prosthesis 204 of the humeral arthroplasty prosthesis 200 can be attached to the humerus 210 via insertion of the stemless humeral anchor prosthesis 204 into the cancellous bone 220. The stemless humeral anchor prosthesis 204 can include a taper or taper adapter 205 that can be coupled to the humeral head prosthesis 202. The stemless humeral anchor prosthesis 204 can be positioned such that the humeral head prosthesis 202 contacts or is proximate to the cut surface 214.

[0037] The humeral head prosthesis 202 and the stemless humeral anchor prosthesis 204 can be manufactured from typical materials for prosthetic implants such as titanium, cobalt chrome, or stainless steel. Such materials can be hard and thus desirable for reducing wear and preventing damage or corrosion. However, such hard materials can be significantly harder than the bone materials to which they are attached. The stemless humeral anchor prosthesis 204 can prevent damage to the humerus 210 by avoiding the installation of a long stem into the cancellous bone 220 that has the potential to crack or damage the cortical bone, particularly when being inserted with a hammer or mallet during the implant procedure. Thus, the humeral arthroplasty prosthesis 200 can be compact in shape and can include a plurality of fins, blades, protrusions, fingers, or wings that can engage the cancellous bone 220 without significantly modifying the humerus 210. Such fins, blades, protrusions, fingers, or wings can advantageously be used as a platform for assembling electronic device components that are to be positioned inside the humeral head prosthesis 202, while other electronic device components are installed in contact with the bone or away from metal components, as discussed with respect to FIGS. 3A - 5.

[0038] In an additional embodiment, the humeral arthroplasty prosthesis 200 can be used in combination with a glenoid prosthesis device that can be implanted within the scapula of a patient that receives the humeral arthroplasty prosthesis 200, as shown within FIG. 1B. Such a glenoid prosthesis can include sensors for collecting data from the glenoid prosthesis and surrounding biological structures. The glenoid prosthesis device can include sensors for collecting various data related to temperature, acceleration, position, and the like. As discussed herein, sensor data from the humeral arthroplasty prosthesis 200 and the glenoid prosthesis can be used in combination with one another to provide feedback to the patient or healthcare provider. In an embodiment, the relative position between the humeral arthroplasty prosthesis 200 and the glenoid prosthesis can be determined from sensor data such as position sensors, proximity sensors, accelerometers, gyroscopes, and the like. The relative position data can be used to determine the assembly of the prosthetic device, the movement of the prosthetic device over time, the wear of the prosthetic device, the range of motion of the joint, and the like.

[0039] FIG. 3A is a perspective view of a humeral anchor prosthesis 300. FIG. 3B is a perspective top view of the humeral anchor prosthesis 300 of FIG. 3A showing a connecting portion 315 for a humeral head prosthesis. FIGS. 3A and 3B are discussed simultaneously. The humeral anchor prosthesis 300 can include a stainless steel humeral anchor prosthesis. The humeral anchor prosthesis 300 can include a base plate 311 and a blade 313. In an embodiment, the humeral anchor prosthesis 300 can include a humeral head implant as described in U.S. Patent No. 8,992,623, titled "Shoulder Prosthesis," by Andrew Hopkins et al., the contents of which are incorporated herein by reference.

[0040] The humeral anchor prosthesis 300 can include a base plate 311 that can include a circular disk having a second distal side and a first proximal side that are connected by an edge surface or rim. The connecting portion 315 can extend in a first direction from a first side of the base plate 311, and the blade 313 can extend in a second direction from a second side of the base plate 311. The connecting portion 315 can include a stud or receptacle for attaching a prosthetic humeral head (e.g., the humeral head prosthesis 202 of FIG. 2B) to the base plate 311. In an embodiment, the connecting portion 315 can include a tapered cylinder-like body. However, the connecting portion 315 can include any suitable connecting means for connecting the humeral head to the humeral anchor prosthesis 300 with high reliability.

[0041] On the distal side of the base plate 311, there is provided a fixing means 312 that helps to firmly fix the humeral anchor prosthesis 300 in the patient's humerus with high reliability. The fixing means 312 can include blades 313 extending from the base plate 311. In an embodiment, four blades 313 can be used. However, in other embodiments, a greater number or a smaller number of blades 313 can be used. In an embodiment, the blade 313 can include a rib or shank having a planar sidewall that extends perpendicularly from the base plate 311. In an embodiment, the blades 313 can be evenly distributed circumferentially around the central axis C. In an embodiment having four blades 313, the angle between adjacent blades 313 can be 90°. However, other angles can be provided between adjacent blades 313, and it is not necessary for the angles between all the blades 313 to be equal. The blades 313 can extend radially from the central axis C. In embodiments of the present disclosure, the configuration of the prosthetic implant can be customized for a particular patient. For example, the number and orientation of the blades 313 can be selected based on the bone density information of a particular patient.

[0042] The blade 313 can be provided with an opening 325. The opening 325 can improve blood circulation and osseointegration of the humeral anchor prosthesis 300. Moreover, the opening 325 and the space 332 help to minimize the size of the humeral anchor prosthesis 300, thus minimizing the surgical impact of the humeral anchor prosthesis 300 while promoting osseointegration. In an embodiment, one or more openings 325 can be used to house and provide support for the electronic device components of the present disclosure. For example, sensors such as a temperature sensor, pH, etc. can be positioned within the opening 325 to reduce the amount of electronic devices housed within a prosthetic head component such as the humeral head prosthesis 202, and advantageously such sensors can be positioned in contact with bone material.

[0043] The radially inner end 330 of the adjacent blade 313 can be connected by a web 327. The web 327 can extend distally from the base plate 311 and can have a length shorter than that of the blade 313. The web 327 can surround a central space 332 adjacent to the base plate 311 without a protrusion. Thus, in the implanted state of the humeral anchor prosthesis 300, the material of the humerus can extend into the space 332 to promote osseointegration. To facilitate this process, the web 327 can be provided with an opening 334 that can improve blood circulation, especially in the region adjacent to the humeral anchor prosthesis 300. Specifically, the opening 334 can enable blood circulation to and from the bone material disposed within the free central space 332. In an embodiment, the central space 332 can be provided with electronic device components as described herein, such as antenna elements or sensor elements.

[0044] The radially outer end 336 of the blade 313 can be provided with a wing 314 extending in the circumferential direction. In the embodiment, the wing 314 can be arranged flush with the outer contour of the base plate 311. The wing 314 can improve the fixation characteristics of the blade 313 and, like the web 327, contribute to the stability and rigidity of the humeral anchor prosthesis 300.

[0045] The distal edges of the wing 314 and the blade 313 can form a cutting edge 329 that can facilitate the implantation of the humeral anchor prosthesis 300. The distal edge of the web 327 is illustrated as not having a cutting edge, but in other embodiments, it can be provided with a cutting edge.

[0046] The geometry of the blade 313 is such that the humeral anchor prosthesis 300 resembles the shape of an arrowhead in a side view, that is, the distal edge of the blade 313 can radially recede towards the radially outer end 336 of the blade 313. The edge of the radially inner end 330 of the blade 313 can be inclined with respect to the central axis C. In other words, the radially inner edge of the blade 313 diverges when viewed along the central axis C from the distal surface of the base plate 311, that is, when viewed from the proximal direction to the distal direction. Accordingly, the free central space 332 can have a conical shape tapered towards the base plate 311.

[0047] FIG. 4 is a perspective bottom view of a stainless steel humeral prosthesis 400 including a prosthetic head component 402, a stainless steel anchor component 404, and an adapter component 406. FIG. 5 is an exploded assembly view of the stainless steel humeral prosthesis 400 of FIG. 4 showing the prosthetic head component 402, the stainless steel anchor component 404, and the adapter component 406. In the embodiment, the stainless steel humeral prosthesis 400 can include a humeral head implant described in U.S. Patent No. 8,506,638 to Thomas M. Vanasse et al. entitled "Shoulder Prosthesis" the content of which is incorporated herein by reference. FIGS. 4 and 5 are discussed simultaneously.

[0048] The patch head component 402 can include a head body 408, a bearing surface 410, an adapter socket 412, a proximal surface 413, an upper chamber 414, and a pocket 415.

[0049] The stainless anchor component 404 can include an anchor body 420, an extension portion 422, an adapter socket 424, an intermediate passage 425, a distal socket 426, a pocket 427, and a protrusion 428.

[0050] The adapter component 406 can include an adapter body 430, a plate 432, a protrusion 434, a driver socket 435, and a passage 436.

[0051] The head body 408 can include a hemisphere or partial sphere having a bearing surface 410 configured, for example, to slide adjacent to a mating prosthesis or natural glenoid fossa. The head body 408 can be manufactured from a hard material such as stainless steel, titanium, CoCr, or another metal. The adapter socket 412 can extend into the proximal surface 413. The adapter socket 412 can be configured to receive the plate 432 of the adapter component 406 to couple the prosthesis head component 402 to the adapter component 406. The plate 432 can be fitted inside the adapter socket 412 using an interference fit such as press fitting or shrink fitting. The adapter socket 412 can be tapered to correspondingly receive the tapered plate 432. The adapter socket 412 can have a depth D. The socket 412 can be configured to receive the entire thickness of the plate 432. The length of the depth D can be further extended, for example, for the purpose of removing weight from the head body 408 by providing a pocket 415. The pocket 415 can have a diameter smaller than the socket 412 and can have an outer wall curved to fit within the geometry of the bearing surface 410. As will be described in further detail below, the socket 412, upper chamber 414, and pocket 415 can be utilized as a storage space for various electronic device modules, components, and elements including sensors and power sources.

[0052] The projection 434 can extend from the plate 432 and can be configured to be inserted into the adapter socket 424 of the stainless steel anchor component 404, thus enabling the stainless steel anchor component 404 to be coupled to the adapter component 406. The projection 434 can be fitted inside the adapter socket 424 using an interference fit such as press fitting or press fit. As is known in the art, the projection 434 can be positioned eccentrically from the plate 432 so that the position of the prosthetic head component 402 relative to the stainless steel anchor component 404 can be varied to accommodate different anatomical geometries. The passage 436 can extend from the plate 432 through the projection 434 into the adapter component 406. The passage 436 can include a driver socket 435 such as a hex socket in the plate 432 to facilitate rotation of the adapter component 406 relative to the stainless steel anchor component 404. In an embodiment, one or both of the projection 434 and the adapter socket 424 can be threaded to facilitate assembly and disassembly.

[0053] The extension portion 422 of the stainless anchor component 404 can include a cylindrical body for accommodating the protrusion 434. The extension portion 422 can extend from the anchor body 420. The adapter socket 424 can be tapered to accommodate the correspondingly tapered protrusion 434. The stainless anchor component 404 can further include a distal socket 426 that can be connected to the adapter socket 424 via an intermediate passage 425. The distal socket 426 and the intermediate passage 425 can enable access from the stainless anchor component 404 and the distal end of the stainless humeral prosthesis 400 to the driver socket 435 and the adapter socket 412. The distal socket 426 and the intermediate passage 425 can facilitate the disassembly of the stainless humeral prosthesis 400. The protrusion 428 can extend radially from the anchor body 420 to provide fixation within the bone substance. In the illustrated embodiment, the stainless anchor component 404 can include six equally spaced protrusions 428. The protrusion 428 can curve axially to form a pocket 427 in which the bone substance can grow throughout to hold the stainless anchor component 404 within the bone. The anchor body 420 and the extension portion 422 can be manufactured from any suitable material such as stainless steel. In an embodiment, the anchor body 420 can be manufactured from or coated with a porous material to promote in-bone growth. As will be described in more detail below, the stainless anchor component 404 as well as other components described herein can provide a platform or frame for assembling various electronic device modules, components, and elements thereon. For example, an electronic device component such as an antenna can be assembled to the distal socket 426 and positioned away from the humeral head prosthesis 202 that can be manufactured from a material capable of shielding or inhibiting the transmission of communication signals. Further, the protrusion 428 can also be used to assemble an electronic device component that benefits from direct contact with the bone substance such as a sensor.Furthermore, as will be discussed in more detail below, any or all of the patch head component 402, the stemless anchor component 404, and the adapter component 406 can be manufactured from materials capable of facilitating the transmission of electrical signals. Thus, the patch head component 402, the stemless anchor component 404, and the adapter component 406 can act as communication conduits between electronic device modules. Examples of materials suitable for the transmission of electrical signals include, without limitation, stainless steel alloys, cobalt-based alloys, and titanium-based alloys.

[0054] The present disclosure can provide a stainless steel prosthetic device, such as a stainless steel humeral head prosthesis, a stainless steel femoral head prosthesis, etc., which can incorporate an electronic device module having sensors and communication devices without the need to modify the outer envelope of the prosthetic device, such as the shape of the prosthetic components that will interact with the surrounding biological structures. In an embodiment, a stainless steel sensor-enabled prosthetic device can incorporate two or more individual electronic device components that can be coupled to two or more individual implant components via lead wires or extensions that allow the individual electronic device components to be electrically connected although spatially separated. Further, the two or more individual components can be placed in an electronic communication state with each other through the conductive properties of the component materials, thereby reducing or eliminating the need for separate wiring. For example, as can be seen in FIG. 5, the adapter socket 412 and the upper chamber 414 can be configured to provide a space for incorporating electronic device components. Similarly, the stemless anchor component 404 can be configured to provide a platform for the assembly of electronic device components that are external to the stainless steel humeral head prosthesis and exposed to the bone. The passageway 436 can be configured as a conduit for facilitating the coupling, e.g., electronic communication, between the electronic device components assembled to the stemless anchor component 404 and the patch head component 402.

[0055] FIG. 6 is a side cross-sectional view of a stainless steel humeral prosthesis 400 having an antenna module 460 attached to an anchor component 404, an electronic device module 462 coupled to a patch head component 402, and an adapter component 406 having an electrical lead 464 extending therethrough. The electrical lead 464 can extend between an electronic device module 462 at a first end and a connector 466 at a second end.

[0056] The antenna module 460 can include a housing 470, a coupling socket 472, an electrical socket 474, and an antenna element 476. The antenna module 460 can include a capsule in which other components are incorporated. In an embodiment, the antenna module 460 can be attached to the stainless anchor component 404 at the socket 424, the intermediate passage 425, or the distal socket 426. In the illustrated embodiment, the housing 470 can include a coupling socket 472 that can include a female receptacle having internal threads configured to receive external threads on the stainless anchor component 404. The electrical socket 474 can be configured to align with the distal socket 426. The electrical socket 474 can provide an electrical contact with the antenna element 476. The antenna element 476 can include a coil or winding configured to interact with a wireless or radio wave signal. In an embodiment, the antenna element 476 can include a communication device, such as a Bluetooth® or Wi-Fi antenna. In an embodiment, the antenna element 476 can include any component or element that requires or otherwise benefits from interaction with an external wireless or radio wave signal. In the illustrated embodiment, the antenna element 476 is inside the housing 470. However, in other embodiments, the antenna element 476 can be exposed outside the housing 470. The housing 470 can be manufactured from a biocompatible material that also enables or facilitates the transmission of communication signals to and from the antenna element 476. In an embodiment, the housing 470 can be manufactured from a polymer or plastic such as PEEK. The housing 470 can have a curved distal end that forms a nose cone to facilitate pressing of the antenna module 460 into bone mass.

[0057] Connector 466 can include an electrical connector configured to engage an electrical socket 474. In an embodiment, connector 466 can include male protrusions and electrical socket 474 can include female receptacles. In an embodiment, connector 466 and electrical socket 474 can include rounded components that can allow for connection of housing 470 to stemless anchor component 404 for various radial orientations of housing 470. Connector 466 can be sized to fit within and pass through passages 436 and distal socket 426.

[0058] The electrical lead 464 can include a wire or a bundle of wires that couples a connector 466 to the electronic device module 462. The electrical lead 464 can include an insulating jacket or can include bare wires. The electrical lead 464 can include a security or reinforcement cable to prevent the connector 466 from being pulled away from the electronic device module 462. The electrical lead 464 can be flexible, for example, to allow the distance between the prosthetic head component 402 and the stainless steel anchor component 404 to vary in order to enable the assembly of the stainless steel humeral prosthesis 400. For example, at the time of assembly of the stainless steel humeral prosthesis 400, e.g., inside the passageway 436, the electrical lead 464 can be bundled between the prosthetic head component 402 and the stainless steel anchor component 404. As discussed in further detail below, in embodiments, the electrical lead 464 can be eliminated and electronic communication between the electronic device module 462 and the antenna module 460, or another electronic device component, can be effected through the materials of the prosthetic head component 402, the stainless steel anchor component 404, and the adapter component 406. In further additional embodiments, the electronic components inside the electronic device module 462 can be separated into a number of sub-components that are in electronic communication with each other through the materials of the prosthetic head component 402, the stainless steel anchor component 404, and the adapter component 406. In these various embodiments, the housing 480 and the various sub-component housings can have openings or conductor ports that engage with the materials of the prosthetic head component 402, the stainless steel anchor component 404, and the adapter component 406 to allow the internal electronic device components to contact the materials of the prosthetic head component 402, the stainless steel anchor component 404, and the adapter component 406.

[0059] The electronic device module 462 can include a housing 480, a first electronic device element 482, and a second electronic device element 484. The housing 480 can be present within the socket 412 of the repair head component 402. The repair head component 402 can be modified from the illustrated embodiment of FIG. 5 to accommodate the housing 480. For example, the upper chamber 414 of the repair head component 402 can be widened and / or deepened or extended into the pocket 415 to accommodate the housing 480. Thus, in an embodiment, the thickness of the head body 408 can be reduced to accommodate the housing 480 without affecting the outer dimensions of the repair head component 402. In the illustrated embodiment, the housing 480 is shown as rectangular, but can have any shape. In an embodiment, the housing 480 can be configured to match the taper of the socket 412 and the upper chamber 414 and the curvature of the pocket 415.

[0060] The housing 480 can include structural elements for housing and protecting a first electronic device element 482 and a second electronic device element 484. In an embodiment, the housing 480 can be manufactured from a polymer or plastic. The first electronic device element 482 and the second electronic device element 484 can include any suitable elements desirable for creating sensing capabilities for the stainless steel humeral prosthesis 400. In an embodiment, the first electronic device element 482 and the second electronic device element 484 can include a controller, a memory device, a communication device, a battery, sensors, such as a pressure sensor, a temperature sensor, an accelerometer, a gyroscope, a thermometer, a strain gauge, etc., as well as other electronic device components. Although the electronic device module 462 is illustrated as having two electronic device elements, fewer or more elements can be used. As discussed with respect to FIG. 9, the electronic device module 462 can include a plurality of different elements for obtaining data from the stainless steel humeral prosthesis 400 and the surrounding biological structure. Further, the stainless steel humeral prosthesis 400 is shown as having two electronic device modules, namely an antenna module 460 and an electronic device module 462 connected by a single electrical lead 464. However, in other embodiments, the stainless steel humeral prosthesis 400 can have three or more electronic device modules connected by two or more electrical leads. Thus, for example, the electronic device element 484 can be positioned remotely from the housing 480 via an electrical lead extending from the electronic device element 482 out of the housing 480. In such an embodiment, the electronic device element 484 can include sensors that benefit from direct contact with bone material and can be assembled to one of the protrusions 428.

[0061] In an embodiment, the electronic device element 482 can include a series of sensors configured to detect the assembly of the prosthetic head component 402 and the adapter component 406 and the assembly of the adapter component 406 and the stainless anchor component 404. In an embodiment, such sensors can include resistance sensors installed in series on the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404 to detect the current passing through the stainless humeral prosthesis 400 and the contact of such components. The resistance measured by the resistance sensor can be measured over time to monitor the assembly of the stainless humeral prosthesis 400 to confirm, for example, whether any of the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404 maintain connection integrity. Similarly, the resistance measurement can be used to measure the insertion of the prosthetic head component 402 and the adapter component 406 and thus the assembly, and the assembly of the adapter component 406 and the stainless anchor component 404. For example, the amount of insertion can be characterized by the amount of electrical resistance passing through the component, and thus, the lower the resistance, the more substantially the insertion is performed. In an embodiment, the resistance can be measured directly through the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404. Thus, a low resistance reading can be used to generate a signal that can be provided to the user, such as an audio signal, a tactile signal, or a visual signal provided to the surgeon, to indicate that the components have been assembled with sufficient force. Further, wear of any of the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404 can be extrapolated from the relative positions of the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404.In an additional embodiment, a spring or other expandable conductor is positioned between the prosthesis head component 402 and the adapter component 406 and between the adapter component 406 and the stainless steel anchor component 404 to form a continuous electrical path through the stainless steel humeral prosthesis 400 even if a separation occurs between any of the prosthesis head component 402, the adapter component 406, and the stainless steel anchor component 404. For example, a spring 468 can be positioned between and attached to the adapter component 406 and the stainless steel anchor component 404. In this way, the electrical resistance through the spring can be differentiated from the electrical resistance through the prosthesis head component 402, the adapter component 406, and the stainless steel anchor component 404. Further, real-time measurements can be taken during implantation of the stainless steel humeral prosthesis 400 to ensure, for example, that the prosthesis head component 402, the adapter component 406, and the stainless steel anchor component 404 are properly assembled, such as by comparing to a predetermined threshold insertion force known to properly assemble these components. Further, position and other sensor data from the glenoid prosthesis can be used in conjunction with data from the stainless steel humeral prosthesis 400 to evaluate assembly, relative positioning, wear, and range of motion.

[0062] Figures 7A through 7C illustrate an exemplary method of assembling and implanting the stainless steel humeral prosthesis 400 of the present disclosure. Figures 7A through 7C illustrate an exemplary method, although other sequences of steps can be used. The antenna module 460 and the electronics module 462 are simplified in Figures 7A through 7C but can be constructed in the same manner as shown in Figure 6.

[0063] FIG. 7A is a first step in the process of assembling the disclosed stainless steel humeral prosthesis 400 that shows an adapter component 406 positioned within socket 412 of the prosthetic head component 402. The housing 480 of the electronic device module 462 can be fitted within socket 412 of the prosthetic head component 402. In an embodiment, the housing 480 can be press-fit within socket 412 or within the upper chamber 414. In an embodiment, the prosthetic head component 402 may be provided in different sizes, in which case the bearing surface 410 has different radii. However, the sockets 412 within the prosthetic head components 402 of different sizes can continue to be the same to enable their respective assembly with the housing 480. In an additional embodiment, the housing 480 can be pre-assembled during the manufacturing process, thus eliminating the need for the user to separately assemble the electronic device module 462 and the prosthetic head component 402. At the driver socket 435, the connector 466 is inserted within the proximal end of the passageway 436 such that the electrical lead 464 can extend across the full length of the adapter component 406. The plate 432 can have a taper and can be press-fit within the socket 412 to connect the adapter component 406 to the prosthetic head component 402.

[0064] Figure 7B shows the second step of the process of assembling the stainless steel humeral prosthesis 400 of the present disclosure, which is an electrical lead 464 that extends through the adapter component 406 and is coupled to the stainless steel anchor component 404 at the antenna module 460. The connector 466 (Figure 7A) can be inserted into the socket 474 (Figure 6). The stainless steel anchor 404 component can be inserted into the bone mass BM. For example, the protrusion 428 can be pressed into the cancellous bone to fix the stainless steel anchor component 404 to the bone mass BM. In an embodiment, the stainless steel anchor component 404 can be inserted into the bone mass BM before connection to the connector 466, and a tool can be used to facilitate the connection between the connector 466 and the socket 474 (Figure 6) for inserting the connector 466 into the extension portion 422. However, in other embodiments, the adapter component 406 and the stainless steel anchor component 404 can be assembled before inserting the protrusion into the bone.

[0065] Figure 7C shows the third step of the process of assembling the stainless steel humeral prosthesis 400 of the present disclosure, which is an adapter component 406 positioned within the socket 424 of the stainless steel anchor component 404. The assembly ring of the prosthesis head component 402 and the adapter component 406 can be moved so as to be close to the stainless steel anchor component 404. Thus, the protrusion 434 can include a taper and can be inserted into the socket 424. The electrical lead 464 can be bent and fitted into the space between the prosthesis head component 402 and the stainless steel anchor component 404, for example, by gathering it inside the passage 436.

[0066] FIG. 8 is a side cross-sectional view of an assembled stainless humerus prosthesis 400 having antenna module 460 and electronic device module 462 connected by rigid electrical leads 490A and 490B. The stainless humerus prosthesis 400 of FIG. 8 can be the same as the stainless humerus prosthesis 400 of FIG. 6, except that connectors 466 and leads 464 can be replaced with electrical leads 490A and 490B. Electrical leads 490A and 490B can include self-attachable components, for example, as in the steps illustrated in FIG. 7C, where adapter component 406 is engaged with stainless anchor component 404. Electrical leads 490A and 490B, protrusions 434 and passages 436, extension portions 422 and sockets 424 can all be configured to extend along central axis CL.

[0067] Electrical leads 490A and 490B can be formed from portions of housing 480 and antenna module 460, respectively. Similarly, all or some of the components of the stainless humerus prosthesis 400 can be made conductive so that electrical signals can be communicated through the stainless humerus prosthesis 400, thus reducing or eliminating the need for internal wiring. In additional embodiments, electrical leads 490A and 490B can be formed from the materials of adapter component 406 and stainless anchor component 404. Electrical leads 490A and 490B can include wires or the like so that electrical signals can be communicated between housing 480 and housing 470.

[0068] FIG. 9 is a block diagram illustrating components of a stainless steel humerus prosthesis 400, including an electronic device module 462 of a prosthetic head component 402 and an antenna module 460 of an anchor component 404. The prosthetic head component 402 and the anchor component 404 can be coupled by an adapter component 406. Although described in relation to the stainless steel humerus prosthesis 400, the electronic device module 462 can be configured to be used with other orthopedic implant devices, such as a prosthetic femoral component, a prosthetic acetabular component, a prosthetic humerus component, and the like. The electronic device module 462 can include a housing 480, a circuit board 540, a processor 542, a memory 544, a switch 546, an input / output (I / O) device 548, a power source 550A, a power source 550B, a charging device 552, a communication device 556, a first sensor 558A, and a second sensor 558B. The housing 480 can be attached to or integrated with the prosthetic head component 402. The electronic device module 462 can be in communication with an interrogation device 560. The interrogation device 560 can include various electronic device devices for powering the electronic device module 462 and obtaining information from the electronic device module 462, such as mobile computing devices (including those via Bluetooth® connection), base stations, dongles, and other electronic device devices. In an embodiment, the interrogation device 560 can be part of the computer system 140 of FIG. 1A.

[0069] The housing 480 can include structural components for holding and supporting other components of the electronic device module 462. The housing 480 may be integrated with, attached to, or disposed within the patch head component 402. The housing 480 can be made of a medical grade plastic material or, for example, other medical grade materials such as stainless steel. The housing 480 can be made of a transparent or translucent material to facilitate the transmission of light through the housing 480 and improve the visibility of any light sources disposed within or on the housing 480. The housing 480 can be sealed to keep the components therein in a dry state and separated from engagement with the environment of the electronic device module 462.

[0070] The circuit board 540 can include structural components for electrically and structurally coupling the electrical components of the electronic device module 462. For example, the circuit board 540 can include a silicon wafer or chip, on which electrical couplings for coupling components such as switches 546, processors 542, memories 544, sensors 558A and 558B, etc. are attached.

[0071] The processor 542 can include an integrated circuit for controlling the operation of components of the electronic device module 462, such as I / O devices 548, charging devices 552, communication devices 556, and sensors 558A and 558B. The processor can execute instructions stored in the memory 544 to operate components of the electronic device module 462, such as charging devices 552 and sensors 558A and 558B.

[0072] Memory 544 can include any suitable storage device, such as non-volatile memory, magnetic memory, flash memory, volatile memory, programmable read-only memory, etc. Memory 544 can include instructions stored internally for the processor 542 to control the operation of the electronic device module 462. For example, memory 544 can include instructions for operating the I / O device 548, the charging device 552, the communication device 556, and the sensors 558A and 558B, as well as for coordinating the output from the electronic device module 462. Memory 544 can further include reference data for comparing data from the sensors 558A and 558B, such as threshold conditions or pressures when the prosthetic head component 402 (FIG. 5) is in a kinematic alignment state or when the secondary power source 550B is in a charged or discharged state.

[0073] Switch 546 can constitute an on / off switch for providing power from the power sources 550A and 550B to the sensors 558A and 558B, etc. Switch 546 can constitute an "alternating operation" switch when transitioning between open and closed states. In an alternating operation switch, the switch can be put into continuous "on" or "off" operations. Switch 546 can include a toggle switch, a knife switch, a relay, or a push-button switch. In an embodiment, the electronic device module 462 does not include a switch, and the electronic device module 462 is powered on as long as at least one of the primary power source 550A and the secondary power source 550B is at least partially charged.

[0074] The I / O device 548 can include one or more devices for receiving input from and transmitting output to a user of the electronic device module 462. For the purpose of operating the electronic device module 462 or obtaining information from the electronic device module 462, the I / O device 548 can include buttons, knobs, dials, and the like. In an embodiment, the I / O device 548 can be omitted, and the electronic device module 462 can communicate with the inquiry device 560 for the purpose of operating the electronic device module 462.

[0075] The I / O device 548 can include devices for providing visual and audio feedback. The I / O device 548 can include devices for generating light waves, such as incandescent bulbs, light emitting diodes, and the like. In an embodiment, the I / O device 548 can be configured to emit light of different colors or wavelengths. The I / O device 548 can provide visual indications when the electronic device module 462 is performing different functions, such as active sensing. For example, the I / O device 548 can be configured to emit orange, yellow, and green light, so that the operator can confirm that the electronic device module 462 is performing different functions or that a communication loss or malfunction has occurred in the electronic device module 462.

[0076] The I / O device 448 can include or can be capable of including a device for creating a wave, such as a sound wave or a vibration wave. In one embodiment, the I / O device 448 can include an auditory device, such as a speaker or amplifier for generating an auditory signal or voice for the purpose of indicating that the electronic device module 462 is in communication with the interrogation device 560. In other embodiments, the I / O device 548 can include a tactile device, such as a reciprocating device or a vibration device, for generating vibrations that can be felt by a surgeon, an operator of the interrogation device 560, or a patient. For example, the wave can communicate with a device worn by a surgeon in the interrogation device 560 that can vibrate when this wave is received.

[0077] The communication device 556 can include one or more devices for receiving an input from the interrogation device 560 or providing an output to the interrogation device 560 via various signals. The communication device 556 can provide a signal 562 to the interrogation device 560 via the antenna module 460. The interrogation device 560 can then display, for example, on a human interface device 564, such as a video display monitor, an indication of information from the electronic device module 462. The interrogation device 560 can further include an I / O device 566 for receiving an input from a user of the interrogation device 560, such as a surgeon, and transmitting an output to this user. The communication device 556 is illustrated as being located within the antenna module 460, but alternatively can be located within the housing 480.

[0078] The communication device 556 can receive a signal 562 from the interrogation device 560 via the antenna module 460 to store information on the memory 544 or to provide information to the processor 542 for operating the switch 546, the charging device 552, the sensors 558A and 558B, the communication device 556, the charging device 552, and other components of the electronic device module 462. In an embodiment, the communication device 556 can communicate using wireless communication signals such as Bluetooth (registered trademark), Wi-Fi, Zigbee (registered trademark), infrared (IR), near field communication (NFC), 3GPP (registered trademark), or other technologies. In an embodiment, the communication device 556 can include a wired connection or can include a port for receiving a wire for a wired connection. In an embodiment, the communication device 556 can communicate using one or more of the IEEE802.15.6 - 2012 protocol, the MICS protocol, and the MBANs protocol described above.

[0079] The communication device 556 can optionally be used in conjunction with an antenna relay 580 that extends outside the housing 480. The antenna relay 580 can include an independently implantable component that can be positioned inside the tissue between the electronic device module 462 and the skin. The antenna relay 580 can be decoupled from each of the electronic device module 462 and the orthopedic implant. Thus, the antenna relay 580 can include a mediating means to enhance or relay the original communication ability of the communication device 556 with a stronger signal outside the patient's body. The antenna relay 580 can be energized by the power from the interrogation device 560 to receive a signal from the electronic device module 462 and re - communicate the same.

[0080] The power source 550A can include an energy storage device such as a battery including an electrochemical cell such as an alkaline battery or a zinc - manganese dioxide battery. In an embodiment, the power source 550A can include a primary battery, i.e., a non - rechargeable battery.

[0081] In an embodiment, one or both of power supplies 550A and 550B can include one or more capacitors that can be charged by a charging device 552, for example, via an inductance signal, a magnetic signal, or an RF energy signal. Thus, while the RF energy can vary during harvesting due to fluctuations in the RF energy signal strength, the operation of the RF energy harvester can charge the capacitor to provide an amount of power suitable for stably operating the electronic device module 462.

[0082] Power supplies 550A and 550B can be configured to provide power to different components of the electronic device module 462. The primary battery or power supply 550A can provide long-term battery charge and can supply power for low-frequency sensor operation throughout the useful life of the electronic device module 462. The secondary battery or power supply 550B can provide short-term battery power and can supply power for high-frequency sensor operation of short duration, for example, during exercise that is part of postoperative rehabilitation. The electronic device module 462 can include one or more of each of power supplies 550A and 550B. Further, in an embodiment, the electronic device module 462 can exclude both power supplies 550A and 550B and can rely only on the power generated by the energy harvesting device. In an embodiment, power supply 550A can include a capacitor, and power supply 550B can include an emergency or backup power supply such as a non-rechargeable battery.

[0083] The charging device 552 can include one or more devices for providing power to power sources 550A and 550B. In an embodiment, the charging device 552 can include a coil that can be energized by an RF field. In an embodiment, the charging device 552 can include a coil that can be energized by a magnetic field. In an embodiment, the charging device 552 can include a magnetic loop antenna such as a copper coil. In an embodiment, the charging device 552 can include one or more devices for converting radio frequency energy or waves into electricity. Examples of energy harvesting devices are described in U.S. Patent No. 9,021,277 to Sheaner et al. (Powercast) entitled "Power Supply Device Using RF Energy Harvesting", which is incorporated herein by reference. In an embodiment, the charging device 552 can include leads or wires that extend from the housing 480 to a location remote from the housing. Such leads or wires can be positioned closer to the patient's skin to better couple to a charger or antenna relay 580, or can extend through the patient's skin, for example, can be percutaneous. Such leads or wires can be installed while closing an access site used for performing a surgical procedure, such as arthroplasty. Such leads or wires can be positioned away from and exposed from metals and other components that can interfere with communication signals so that radio wave signals can be more efficiently communicated and / or received, for example, may not be covered by housing components. In an additional embodiment, the charging device 552 can be one or more components of an implanted device that can conduct electricity, such as the prosthetic head component 402, the adapter component 406, and the stainless anchor component 404 (FIG. 6). Further, the charging device 552 can include leads, such as wires, that can be positioned near the surface of the skin or protrude through the skin to facilitate charging, such as electromagnetic induction charging.The lead itself can facilitate electromagnetic induction charging or can be connected to components for inductance charging, such as pads or coils, to promote efficient energy transfer. For example, a patient or technician can position an inductance charger very close to the lead connected to the charging device 552 to wirelessly charge the device of the present disclosure.

[0084] Sensors 558A and 558B can include a variety of different sensors such as temperature, pH, force, vibration, shock, position, movement, capacitance, conductance, impedance, etc. Only one of sensors 558A and 558B can be included within the electronic device module 462, or three or more sensors can also be included within the electronic device module 462.

[0085] The electronic device module 462 can be customized to include only the sensors and input / output devices desired for a particular procedure.

[0086] FIG. 10A is a side cross-sectional view of a humeral head implant 600 capable of using sensors, including a prosthetic head component 602, an electronic device module 604, an antenna 606, and a load cell 608. The prosthetic head component 602 can include an adapter socket 612, a proximal surface 614, an upper chamber 616, and a connection surface 618.

[0087] The prosthetic head component 602 can include components that form a prosthetic humeral head as discussed herein. The articulating surface 618 can be configured to slide in contact with a mating component such as a bone socket including an acetabulum or a prosthetic acetabulum or a natural acetabulum. The proximal surface 614 can be configured to be near or in contact with the resected bone surface of the humerus. An adapter such as the adapter component 630 of FIG. 10B or the adapter component 406 of FIGS. 3-5 can be positioned within the socket 612, and this adapter can extend into the upper chamber 616. The adapter can be coupled to the socket 612 via a Morse taper. An electronic device module 604 can be positioned within the prosthetic head component 602 so as to be in communication with the upper chamber 616. Specifically, the electronic device module 604 can be positioned within the prosthetic head component 602 such that the load cell 608 can extend into the upper chamber 616. In an additional embodiment, the load cell 608 can extend into the socket 612. In an embodiment, the prosthetic head component 602 can include an additional pocket or chamber above the upper chamber 616 for housing the electronic device module 604. The form factor of the electronic device module 604 can be configured to fit within a cavity within the prosthetic head component 602, for example, between the proximal surface 614 and the articulating surface 618, to avoid changes to the shape of the prosthetic head component. The electronic device module 604 can be fitted within the prosthetic head component 602 during manufacture, thus eliminating additional intraoperative steps for the surgeon or technician. The electronic device module 604 can be secured within the prosthetic head component 602 via press fit, adhesive, screw engagement, or other means. The electronic device module 604 can include a housing 620 within which electronic device components are positioned. The antenna 606 and the load cell 608 can be attached to the housing 620 or can extend through the housing 620. The electronic device module 604 can be configured similarly to the electronic device module 462 for placement of the housing 480 (FIGS. 6-8) within the prosthetic head component 602.

[0088] As described herein, the electronic device module 604 can include an antenna 606 for communicating with other electronic device modules or external communication devices. In an embodiment, the antenna 60 can include a wire or coil of a conductive material suitable for transmitting wireless signals. In an embodiment, the electronic device module 604 can include, for example, an antenna module 460 (FIG. 6) attached thereto or remotely located therefrom via electrical leads 464. In an embodiment, the electronic device module 604 can be configured in a similar form to the electronic device module 462 depicted in FIG. 9, where one of the sensors 558A and 558B includes a load cell 608 and the antenna module 460 includes an antenna 606.

[0089] As can be seen by referring to FIG. 10A, the antenna 606 can be positioned in contact with the material 622 of the prosthetic head component 602. In an embodiment, the antenna 606 can be completely surrounded by the material 622 of the prosthetic head component 602, except for the portion attached to the electronic device module 604. Thus, it may be difficult for wireless communication signals such as Bluetooth®, WiFi, Zigbee®, infrared (IR), near field communication (NFC), 3GPP®, or other technologies to pass through the material 622 of the humeral head. In the present disclosure, the material 622 of the prosthetic head component 602 can be made of a material through which wireless communication signals can pass. In an embodiment, the material 622 of the prosthetic head component 602 can include a material that improves the transmission of wireless communication signals compared to a metal material. In an embodiment, the material 622 can include a pyrolytic carbon material and a ceramic material. In an embodiment, the material 622 of the prosthetic head component 602 can include aluminum oxide (Al2O3). In an embodiment, the prosthetic head component 602 can include a composite material of metal and ceramic components as described in U.S. Patent No. 9,248,020 by Popoola et al., which is incorporated herein by reference. For example, a thin layer of a metal material can be used to provide structural support and facilitate the communication of electronic communication signals, and a ceramic layer can be added to the metal layer to provide additional strength without interfering with wireless communication signals. In an embodiment, the material 622 of the prosthetic head component 602 can be partially (e.g., in the case of a metal or ceramic substrate) or completely made of a polymer, such as polyethylene. Thus, in the present disclosure, the material 622 of the humeral head 603 can further have the ability to transmit electronic and wireless communication signals, particularly compared to a humeral head prosthesis made entirely or primarily of a metal material.Since the material 622 enables or enhances the ability to transmit wireless and electronic communication signals therethrough, the prosthetic head component 602 can be configured to include the electronic device module 604 within the boundaries, space or envelope of an existing prosthetic humeral head design, or the prosthetic humeral head prosthesis can be designed without the need to expand the desired shape or envelope of the design to specifically accommodate the electronic device components. Thus, for example, features such as the load cell 608 can be included in convenient locations within the prosthetic head component 602 to interact with other components of the biological structure or the humeral head implant 600.

[0090] Figure 10B is a side cross-sectional view of the humeral head implant 600 with the sensor enabled, shown in Figure 10A, with the adapter component 630 positioned within the adapter socket 612 such that it engages the load cell 608. The adapter component 630 can include a plate 632, a protrusion 634, a dome 636, and a passage 638. In an embodiment, the adapter component 630 can be configured similar to the adapter component 406 (Figures 6 - 8). The plate 632 can engage the socket 612, for example, through a Morse taper as described. The protrusion 634 can extend downwardly or proximally from the plate 632 to facilitate coupling with an anchor component, as described herein. The passage 638 can extend through the adapter component 630 to allow for the passage of wiring, tethers, and communication lines, as described herein. In an embodiment, the passage 638 can be omitted. The dome 636 can extend upwardly or distally from the plate 632 to enter the upper chamber 616. The dome 636 can be configured to engage the load cell 608. In an embodiment, the dome 636 can be omitted and the load cell 608 can pass through the upper chamber 616 and contact the plate 632. Further, the dome 636 can be replaced with a protrusion or projection starting from the plate 632 that contacts the load cell 608. For example, the adapter component 630 can include a cylindrical protrusion, a pyramidal protrusion, a linear protrusion, etc. In various embodiments, a portion of the adapter component 630 can be configured to engage the load cell 608 within the adapter socket 612 and / or the upper chamber 616.

[0091] In an embodiment, the dome 636 can be configured to fully or partially push down the load cell 608 to provide an indication of the position of the adapter component 630 relative to the prosthesis head component 602. Correspondingly, the load cell 608 can be configured to provide an output signal having a magnitude or strength corresponding to the amount or distance by which the load cell 608 is pushed down, such that the load cell 608 can provide a variable output. For example, the dome 636 can project upwardly beyond a horizontal plane 640 that defines the junction of the socket 612 and the upper chamber 616. In an embodiment, the load cell 608 can be positioned at the center of the humeral head implant 600 where the sensor is usable along the centerline CL. Similarly, the peak of the dome 636 can be centered along the centerline CL. Thus, regardless of the relative rotational position between the adapter component 630 and the prosthesis head component 602, the dome will engage the load cell 608. When the adapter component 630 is fully or properly installed within the socket 612, the dome 636 can engage the load cell 608 and fully push down the load cell 608 to register a complete coupling between the adapter component 630 and the prosthesis head component 602. When the adapter component 630 is partially or improperly installed within the socket 612, the dome 636 can partially engage the load cell 608 and partially push down the load cell 608, potentially registering an incomplete coupling between the adapter component 630 and the prosthesis head component 602. For example, if the adapter component 630 is inserted into the socket 612 such that the plate 632 is not parallel to the plane 640, a portion of the adapter component 630 may be fully installed, while another portion of the adapter component 630 may not be fully installed. Thus, the load cell 608 is partially pushed down, yet the surgeon may still feel that the adapter component 630 is firmly in place. In one embodiment, the load cell 608 can register a signal of approximately 500 Newtons for a fully installed adapter component 630, which can decrease proportionally as the installation completeness of the adapter component 630 decreases.

[0092] The load cell 608 can include a pressure sensor. The load cell 608 can include any suitable force or pressure sensor or reader, such as, for example and without limitation, a piezoelectric sensor, a force-sensing resistor, a strain gauge, a load cell, a potentiometer, a barometer, etc. Exemplary force sensors include force-sensing resistors or capacitive flex circuits, piezoelectric films, piezoelectric elements, piezoresistors and piezoelectric polymers, metal foil strain gauges, semiconductor strain gauges, piezoresistors and capacitive pressure sensors, interferometric optical sensors, path displacement optical sensors, fiber optic force sensors, and other suitable sensing techniques. In other embodiments, the load cell 608 can additionally or alternatively include proximity sensors, contact sensors, gyroscopes, accelerometers, motion sensors, inertial measurement units (IMUs), etc.

[0093] The load cell 608 can be used to provide preoperative and intraoperative feedback regarding the assembly of the prosthetic head component 602 and the adapter component 630 based on the detected force or displacement of the load cell 608 by the adapter component 602. The feedback can similarly be used, for example, to determine the implantation, insertion, proper installation, etc. of the prosthetic device, and can include, for example, insertion force, acceleration data, and other sensor data that can be analyzed and evaluated. The insertion force can be compared to threshold insertion force data stored in an electronics module 604, a controller (e.g., interrogation device 560 (FIG. 9)), or other location that correlates the displacement or force applied to the load cell 608 to the proper installation or assembly of the prosthetic head component 602 and the adapter component 630. The feedback can similarly provide postoperative feedback, for example, via the use of accelerometers, inertial sensors, or motion sensors, to provide data regarding the patient's activity and the use of the humeral head implant 600 where the sensor is available.

[0094] The humeral head implant 600 capable of using sensors can include a prosthetic head component 602 having a cavity for housing a battery, an electronic device, a sensor, and an antenna. The battery can provide power to the sensor to enable data collection for a certain number of years after implantation. The data collected by the sensor can be transmitted via the antenna to a base station near the humeral head implant 600 capable of using sensors and uploaded to an application so that the user can examine it with a computer device. The sensor can include an inertial measurement unit (IMU) and a load cell. The load cell can be used during the operation to ensure that the head is properly installed and monitor the potential relaxation of the head. The inertial measurement unit can be used after the operation to collect a certain range of motion data that is likely to assist in relaying the progress of recovery and potential complications.

[0095] In a first embodiment, the humeral head implant 600 capable of using sensors can include an antenna 606 and a load cell 608 as illustrated in FIG. 10B. The prosthetic head component can include a ceramic material, and the passage 638 of the adapter component 630 may be deleted. In a second embodiment, the humeral head implant 600 capable of using sensors can include a load cell 608 and an antenna module 460 instead of the antenna 606. The adapter component 630 can include a passage 638 for the electrical lead 464, and the humeral head implant 600 can include a ceramic material, a metal material, or a combination thereof.

[0096] The systems, devices, and methods discussed in this application are useful in providing implantable medical devices having sensors for collecting patient and implant data. The implantable medical devices can be appropriately sized and shaped without the need to redesign existing medical devices to accommodate electronics. The implantable medical devices described herein can have separable electronic device packages that can be positioned within or attached to the implantable medical device at strategic locations that utilize available internal space and external attachment locations. In this way, various modules and components can be positioned in predetermined locations to improve performance while utilizing the limited available space on the implantable medical device.

Example

[0097] Example 1 is a humeral arthroplasty system including a sensor device, the humeral head including a first portion of the circuit of the sensor device, the humeral head including an adapter socket, a tapered adapter configured to be installed inside the adapter socket, a stainless steel humeral anchor connectable to the tapered adapter, and a second portion of the circuit of the sensor device extending into the adapter socket.

[0098] In Example 2, optionally, the subject matter of Example 1 can include that the tapered adapter and the stainless steel humeral anchor can include a central bore extending therethrough, and that the second portion of the circuit of the sensor device can be connected to the first portion by an electrical circuit extending through the tapered adapter.

[0099] In Example 3, optionally, the subject matter of Example 2 can include that the first portion of the circuit of the sensor device can include a power source.

[0100] In Example 4, optionally, the subject matter of Example 3 can include that the first portion of the circuit can include a sensor circuit.

[0101] In Example 5, optionally included in the subject matter described in any one or more of Examples 2 to 4 is that the second part may include an antenna or a wireless communication device.

[0102] In Example 6, optionally included in the subject matter of Example 5 is that the second part may include an additional sensor circuit.

[0103] In Example 7, optionally included in the subject matter of any one or more of Examples 5 to 6 is that the second part may further include a communication circuit coupled to the antenna.

[0104] In Example 8, optionally included in the subject matter described in any one or more of Examples 2 to 7 is that the electrical circuit extending through the tapered adapter may be an electrical lead.

[0105] In Example 9, optionally included in the subject matter of Example 8 is that the electrical lead may be a flexible wire wired into the first part of the circuit of the sensor device.

[0106] In Example 10, optionally included in the subject matter of Example 9 is that the electrical lead may include a connector on the first end opposite to the first part of the circuit of the sensor device.

[0107] In Example 11, optionally included in the subject matter of Example 10 is that the electrical lead can be coupled to the second part of the circuit of the sensor device via the connector.

[0108] In Example 12, optionally included in the subject matter described in any one or more of Examples 2 to 11 is that the electrical circuit extending through the tapered adapter may be embedded in the humeral head, the tapered adapter, and the stainless humeral anchor, and may include a first circuit path configured to conduct a first electrical signal between the first part of the circuit and the second part of the circuit.

[0109] In Example 13, optionally included in the subject matter of Example 12 is that an electrical circuit extending through the taper adapter can include a second circuit path that is at least embedded within the taper adapter and configured to conduct a second electrical signal between a first portion of the circuit and a second portion of the circuit.

[0110] In Example 14, optionally included in the subject matter of Example 13 is that the second electrical signal can be a return path for the first electrical signal, and an electrical circuit extending through the taper adapter can be configured to transmit power from a first portion of the circuit to a second portion of the circuit.

[0111] In Example 15, optionally included in the subject matter described in any one or more of Examples 12 to 14 is that the first circuit path can be formed by a first electrical conductor embedded within a taper adapter that can be electrically connected to a second electrical conductor embedded within the stainless humeral anchor.

[0112] In Example 16, optionally included in the subject matter of Example 15 is that the stainless humeral anchor can complement the first circuit path by an internal electrical connection between the second electrical conductor and a second portion of the circuit.

[0113] In Example 17, optionally included in the subject matter described in any one or more of Examples 13 to 16 is that the second circuit path can include a first conductive bias member that can electrically connect the taper adapter and a first portion of the circuit, and a second conductive bias member that can electrically connect the taper adapter and the stainless humeral anchor.

[0114] In Example 18, optionally included in the subject matter described in any one or more of Examples 12 to 17 is that one of the first part of the circuit or the second part of the circuit may include a measurement circuit configured to measure a parameter of a first circuit path that correlates with the amount of insertion between the tapered adapter and the humeral head or between the tapered adapter and the stainless humeral anchor.

[0115] In Example 19, optionally included in the subject matter of Example 18 is that the amount of insertion may be compared with a threshold insertion value indicating that the humeral head, the tapered adapter, and the stainless humeral anchor are assembled.

[0116] In Example 20, optionally included in the subject matter described in any one or more of Examples 18 to 19 is that the amount of insertion is compared with a threshold insertion value sufficient to withstand an expected physiological load, indicating that the humeral head, the tapered adapter, and the stainless humeral anchor are assembled.

[0117] In Example 21, optionally included in the subject matter described in any one or more of Examples 12 to 20 is a glenoid prosthesis that may further include a glenoid sensor, and the glenoid sensor may be configured to communicate with at least one of the first part of the circuit and the second part of the circuit.

[0118] In Example 22, optionally included in the subject matter described in any one or more of Examples 2 to 21 is that an electrical circuit can extend through the tapered adapter and may include an electrical circuit passing through the material of the tapered adapter.

[0119] In Example 23, optionally included in the subject matter described in any one or more of Examples 1 to 22 is that the humeral head may at least include a portion made of a ceramic material.

[0120] In Example 24, optionally, the subject matter of Example 23 may include that the humeral head may be entirely manufactured of a ceramic material and that the humeral head includes a pocket for accommodating a first portion of the circuit.

[0121] In Example 25, optionally, the subject matter described in any one or more of Examples 1 to 24 may include that a second portion of the circuit of the sensor device can include a force sensor extending into the adapter socket, and that the tapered adapter can be configured to engage the force sensor when installed in the adapter socket.

[0122] In Example 26, optionally, the tapered adapter can be configured to fully depress the force sensor when the tapered adapter is fully installed in the adapter socket, and the tapered adapter can be configured to partially depress the force sensor when the tapered adapter is partially installed or misaligned in the adapter socket.

[0123] In Example 27, optionally, the force sensor can be configured to generate a full signal when fully depressed and can be configured to generate a partial signal when partially depressed.

[0124] Each of these non-limiting examples can be self-standing or can be combined in various substitutions or combinations with one or more of the other examples.

[0125] Various notes The detailed description above includes reference to the accompanying drawings, which form a part of the detailed description. The drawings, by way of example, illustrate specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those illustrated or described. However, the inventor also contemplates examples in which only the elements illustrated or described are provided. Further, the inventor also contemplates examples (or one or more aspects thereof) in which any combination or substitution of any of the elements illustrated or described is used with respect to any particular example (or one or more aspects thereof) or any other example (or one or more aspects thereof) illustrated or described herein.

[0126] In the event of any conflict in usage between this specification and any document incorporated by reference herein, the usage in this specification shall govern.

[0127] In this specification, the terms "a" or "an" are used to include one or more, regardless of any other instances or uses such as "at least one" or "one or more", as is common in patent documents. In this specification, the term "or" is used to mean non-exclusive or, so that "A or B" includes, unless otherwise indicated, "A but not B", "B but not A", and "A and B". In this specification, the terms "including" and "in which" are used as the plain English equivalents of the terms "comprising" and "wherein", respectively. Similarly, in the following claims, the terms "including" and "comprising" are open-ended. That is, a system, device, article, composition, preparation, or process that includes elements in addition to those recited after such terms in the claims is still considered to be within the scope of that claim. Moreover, in the following claims, the terms "first", "second", and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0128] The method embodiments described herein can be implemented, at least in part, mechanically or by a computer. Some embodiments can include a computer-readable medium or a machine-readable medium encoded with instructions operable to configure an electronic device to perform a method as described in the embodiments above. Implementations of such methods can include code, such as microcode, assembly language code, high-level language code, and the like. Such code can include computer-readable instructions for performing various methods. The code can form portions of a computer program product. Further, in one embodiment, the code can be tangibly stored, for example, on one or more volatile, non-transitory, or non-volatile tangible computer-readable media during execution or at other times. Examples of such tangible computer-readable media can include, without limitation, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks, digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), and the like.

[0129] The above description is intended to be illustrative rather than restrictive. For example, the above embodiments (or one or more aspects thereof) may be used in combination with each other. For example, other embodiments may be used by those skilled in the art upon reviewing the above description. The abstract is provided to comply with 37 C.F.R. § 1.72(b) so that readers can quickly check the content of the technical disclosure. The abstract is submitted with the understanding that it is not to be used to interpret or limit the scope or meaning of the claims. Similarly, in the "Detailed Description" above, various features may be grouped together to simplify the present disclosure. This should not be construed as intending that features of the disclosed subject matter not claimed are essential to any of the claims. Rather, the inventive subject matter may lie in less than all of the features of the particular embodiments disclosed. Accordingly, the following claims are hereby incorporated herein by reference as examples or embodiments, and each claim stands on its own as a separate embodiment, and such embodiments are intended to be combinable with each other in various combinations or permutations. The scope of the present invention should be determined with reference to such appended claims, along with the full scope of equivalents to which the claims are entitled.

Claims

1. A humeral joint forming system including a sensor device, a humeral head including a first portion of a circuit of the sensor device, the humeral head including an adapter socket, a tapered adapter configured to be installed inside the adapter socket, a stainless steel humeral anchor connectable to the tapered adapter, a second portion of the circuit of the sensor device extending into the adapter socket, and a humeral joint forming system including the same.

2. The tapered adapter and the stainless steel humeral anchor include a central bore extending therethrough, and the second portion of the circuit of the sensor device is connected to the first portion by an electric circuit extending through the tapered adapter. The humeral joint forming system according to Claim 1.

3. The first portion of the circuit of the sensor device includes a power source. The humeral joint forming system according to Claim 2.

4. The first portion of the circuit further includes a sensor circuit. The humeral joint forming system according to Claim 3.

5. The second portion includes an antenna or a wireless communication device. The humeral joint forming system according to any one of Claims 2 to 4.

6. The second portion includes an additional sensor circuit. The humeral joint forming system according to Claim 5.

7. The second portion further includes a communication circuit coupled to the antenna. The humeral joint forming system according to Claim 5.

8. The electric circuit extending through the tapered adapter is an electric lead. The humeral joint forming system according to any one of Claims 2 to 7.

9. The electric lead is a flexible wire wired inside the first portion of the circuit of the sensor device. The humeral joint forming system according to Claim 8.

10. The electric lead includes a connector on a first end opposite to the first portion of the circuit of the sensor device. The humeral joint forming system according to Claim 9.

11. The electric lead is coupled to the second portion of the circuit of the sensor device via the connector. The humeral joint forming system according to Claim 10.

12. The electrical circuit extending through the tapered adapter is embedded within the humeral head, the tapered adapter, and the stainless humeral anchor, and includes a first circuit path configured to conduct a first electrical signal between the first portion of the circuit and the second portion of the circuit. The shoulder joint forming system according to any one of claims 2 to 7.

13. The electrical circuit extending through the tapered adapter is embedded at least within the tapered adapter, and includes a second circuit path configured to conduct a second electrical signal between the first portion of the circuit and the second portion of the circuit. The shoulder joint forming system according to claim 12.

14. The second electrical signal is a return path for the first electrical signal, and the electrical circuit extending through the tapered adapter is configured to transmit power from the first portion of the circuit to the second portion of the circuit. The shoulder joint forming system according to claim 13.

15. The first circuit path is formed by a first electrical conductor embedded within the tapered adapter that is electrically connected to a second electrical conductor embedded within the stainless humeral anchor. The shoulder joint forming system according to claim 12.

16. The stainless humeral anchor complements the first circuit path by an internal electrical connection between the second electrical conductor and the second portion of the circuit. The shoulder joint forming system according to claim 15.

17. The second circuit path includes a first conductive bias member that electrically connects the tapered adapter and the first portion of the circuit, and a second conductive bias member that electrically connects the tapered adapter and the stainless humeral anchor. The shoulder joint forming system according to any one of claims 13 to 15.

18. One of the first portion of the circuit or the second portion of the circuit includes a measurement circuit configured to measure a parameter of the first circuit path that correlates with the amount of interference between the tapered adapter and the humeral head, or between the tapered adapter and the stainless humeral anchor. The shoulder joint forming system according to claim 12.

19. The upper arm joint formation system according to claim 18, wherein the amount of insertion is compared with a threshold insertion value indicating that the humeral head, the tapered adapter, and the stainless humeral anchor are assembled.

20. The upper arm joint formation system according to claim 18, wherein the amount of insertion is compared with a threshold insertion value indicating that the humeral head, the tapered adapter, and the stainless humeral anchor are assembled in a state sufficient to withstand an expected physiological load.

21. The upper arm joint formation system according to claim 12, further comprising a glenoid prosthesis including a glenoid sensor, wherein the glenoid sensor is configured to communicate with at least one of the first portion of the circuit and the second portion of the circuit.

22. The upper arm joint formation system according to claim 2, wherein the electrical circuit extending through the tapered adapter includes an electrical circuit passing through the material of the tapered adapter.

23. The upper arm joint formation system according to any one of claims 1 to 22, wherein the humeral head includes at least a portion made of a ceramic material.

24. The upper arm joint formation system according to claim 23, wherein the humeral head is entirely made of a ceramic material, and the humeral head includes a pocket for accommodating the first portion of the circuit.

25. The second portion of the circuit of the sensor device includes a force sensor extending inside the adapter socket, and the tapered adapter is configured to engage with the force sensor when the tapered adapter is installed inside the adapter socket. The upper arm joint formation system according to claim 1.

26. The tapered adapter is configured to completely push down the force sensor when the tapered adapter is fully installed inside the adapter socket, and The tapered adapter is configured to partially push down the force sensor when the tapered adapter is partially installed inside the adapter socket or is not properly aligned. The upper arm joint formation system according to claim 25.

27. The force sensor is configured to generate a full signal when fully pushed down, and The force sensor is configured to generate a partial signal when partially pushed down. The humeral joint forming system according to claim 26.

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