MEASUREMENT SYSTEM CONFIGURED TO SUPPORT BALL JOINT INSTALLATION AND METHOD THEREFOR

Abstract

To provide a favorable system for kinetic assessment and formation of a prosthetic joint.SOLUTION: The system comprises a prosthetic component including sensors and circuitry that are configured to measure the load, the position of the load on a curved surface, the joint stability, the range of motion, and the impingement. The system is for a ball and socket joint of a musculoskeletal system. The system includes a computer having a display configured to graphically display quantitative measurement data to support rapid understanding of information. The kinetic assessment measures joint alignment under loading similar to that of a final joint installation. The kinetic assessment can use trial or permanent prosthetic components. Adjustments can be made to the load magnitude, the position of the load and the joint alignment that are applied by various means, so as to fine-tune the installation.SELECTED DRAWING: Figure 28

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 742,179, filed October 5, 2018, and U.S. Provisional Application No. 62 / 742,207, filed October 5, 2018, all of which are incorporated herein by reference.

[0002] The present invention relates generally to medical and surgical devices, and more particularly to measuring parameters associated with the musculoskeletal system. [Background technology]

[0003] The mammalian musculoskeletal system is subject to breakdown due to many factors, including environment, genetics, diet, use, and aging. Musculoskeletal joints typically involve two or more bones that move relative to one another. Movement is made possible by muscle tissue and tendons attached to the joint. Ligaments hold one or more articulating bones in position and stabilize them. Cartilage is a wear surface that prevents bone-to-bone contact, distributes loads, and reduces friction.

[0004] There has been significant growth in the repair of the human musculoskeletal system. In general, orthopedic prostheses have evolved over time using animal testing, empirical evidence, simulation data, mechanical prototypes, and patient data. The tools used in orthopedic surgery have improved over the years but have remained substantially unchanged. Therefore, the basic procedures for orthopedic joint replacement have been standardized to meet the general needs of a wide population. While the tools, procedures, and prostheses meet the general needs, each replacement procedure varies significantly from patient to patient. Compensating for these individual variations relies on the surgeon's skill in adapting and fitting the replacement joint using the available tools for the specific situation. Providing real-time, quantitative measurement data to support the placement of prosthetic components or artificial joints is highly beneficial. [Brief explanation of the drawings]

[0005] [Figure 1] 1 is an illustration of a shoulder prosthesis in accordance with an exemplary embodiment; [Figure 2] 1 is an illustration of a shoulder prosthesis in accordance with an exemplary embodiment; [Figure 3] 1 is an illustration of a measurement device in a shoulder joint system in accordance with an exemplary embodiment; [Figure 4A] 4 is a flow chart for shoulder joint placement using the measurement device of FIG. 3 according to an exemplary embodiment. [Figure 4B] 4B is a continuation of the flow diagram from FIG. 4A for shoulder joint placement using the measurement device of FIG. 3 in accordance with an exemplary embodiment. [Figure 5] FIG. 1 is an exploded view of a metering device showing components in accordance with an exemplary embodiment. [Figure 6] FIG. 1 is an exploded side view of a metering device in accordance with an exemplary embodiment. [Figure 7] 1 is an illustration of an upper housing coupled to a lower housing in accordance with an exemplary embodiment; [Figure 8] 1 is a cross-sectional view of a metering device according to an exemplary embodiment. [Figure 9] 1 is an illustration of mechanical features of a housing of a metering device in accordance with an illustrative embodiment; [Figure 10] 1 is a cross-sectional view of a portion of an enclosure showing a sensor between an upper housing and a lower housing according to an exemplary embodiment. [Figure 11] 1 is a cross-sectional view of a metering device illustrating the outer curved surface of the upper housing in accordance with an exemplary embodiment. [Figure 12] 10 is an illustration of a sensor snap formed in a lower housing in accordance with an illustrative embodiment; [Figure 13] FIG. 10 is a cross-sectional view of a lower housing showing solder holes according to an exemplary embodiment. [Figure 14] 1 is an illustration of a support structure within a lower housing configured to couple to a flexible interconnect in accordance with an illustrative embodiment; [Figure 15]10 is a cross-sectional view of a portion of an upper housing, a lower housing, and a humeral tray according to an exemplary embodiment. [Figure 16] 1 is an illustration of a housing snap on a metering device that couples an upper housing to a lower housing in accordance with an illustrative embodiment; [Figure 17] 10 is an illustration of a rigid snap extending from a lower housing in accordance with an exemplary embodiment; [Figure 18] 1 is an illustration of an O-ring in a metering device in accordance with an illustrative embodiment; [Figure 19] 1 is an illustration of a lower housing containing electronic circuitry in accordance with an illustrative embodiment; [Figure 20] 1 is an illustration of a flexible interconnect in accordance with an illustrative embodiment; [Figure 21] 1 is an illustration of a measurement device in accordance with an illustrative embodiment; [Figure 22A] 1 is an illustration of a GUI on a display of a computer in accordance with an exemplary embodiment. [Figure 22B] 10 is an illustration of a GUI showing impingement in accordance with an illustrative embodiment; [Figure 23] 10 is an illustration of a GUI on a display coupled to a computer displaying sensor information related to range of motion from a measurement device, according to an exemplary embodiment. [Figure 24] 10 is an illustration of an options screen in accordance with an illustrative embodiment; [Figure 25] 10 is an illustration of a range of motion (ROM) overlay on GUI 380 in accordance with an exemplary embodiment. [Figure 26] 10 is an illustration of a GUI showing impingement range of motion assessment in accordance with an illustrative embodiment; [Figure 27A] 1 is an illustration of measurement data from a measurement device in accordance with an illustrative embodiment; [Figure 27B] 1 is an illustration of a measurement device transmitting measurement data to a computer and displaying the measurement data on a display in accordance with an exemplary embodiment; [Figure 28]22 shows a cross-sectional view of the outer curved surface of the measurement device as shown in FIG. 21 according to an exemplary embodiment. [Figure 29A] 1 is an illustration of a spherical coordinate system for calculating forces and positions in accordance with an illustrative embodiment; [Figure 29B] 10 is an example of force and position calculations related to sensor location according to an illustrative embodiment; [Figure 30] 10 is an illustration of a calculation of force magnitude from measurement data from sensors in accordance with an illustrative embodiment; [Figure 31] 10 is an illustration showing calculation of a position of an applied load on an exterior curved surface of a measurement device using measurement data from a sensor in accordance with an illustrative embodiment; [Figure 32] FIG. 1 is a block diagram of electronic circuitry within a measurement device in accordance with an illustrative embodiment. [Figure 33] FIG. 1 is a block diagram of a system or computer according to an exemplary embodiment. [Figure 34] 1 is an illustration of a communications network for metering and reporting in accordance with an illustrative embodiment; [Figure 35] 1 is an illustration of a robot supporting placement of a shoulder joint in accordance with an illustrative embodiment; [Figure 36] 1 illustrates a measurement device in accordance with an exemplary embodiment. [Figure 37A] FIG. 1 is a top view of a metering device in accordance with an exemplary embodiment. [Figure 37B] 1 is an illustration of a measurement device showing an exterior curved surface in accordance with an illustrative embodiment; [Figure 37C] FIG. 1 is a side view of a metering device in accordance with an exemplary embodiment. [Figure 37D] FIG. 10 is a front view of a gauging device illustrating an undercut formed in a shim in accordance with an exemplary embodiment; [Figure 38] FIG. 1 is an exploded view of a metering device in accordance with an exemplary embodiment. [Figure 39] 1 is an illustration of a cavity in a lower housing of a metering device in accordance with an illustrative embodiment; [Figure 40]1 is a cross-sectional view of a metering device according to an exemplary embodiment. [Figure 41A] 1 illustrates a metrology device including a first shim in accordance with an exemplary embodiment; [Figure 41B] 1 illustrates a metrology device including a second shim in accordance with an exemplary embodiment; [Figure 42] 10 is a cross-sectional view of an exterior curved surface of an upper housing modified for direct loading into a predetermined area of ​​the exterior curved surface in accordance with an exemplary embodiment; [Figure 43] FIG. 1 is a block diagram of loading a metering device in accordance with an illustrative embodiment. [Figure 44] 1 is an illustration of a metering device illustrating different regions of an exterior curved surface of an upper housing in accordance with an illustrative embodiment; DETAILED DESCRIPTION OF THE INVENTION

[0006] The following description of the embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0007] For simplicity and clarity of the drawing(s), elements in the figures are not necessarily to scale, are merely schematic and non-limiting, and the same reference numbers in different figures refer to the same elements unless otherwise specified. Furthermore, for simplicity of explanation, descriptions and details of well-known steps and elements have been omitted. It should be noted that if an item is defined in one figure, it may not be described or further defined in the next figure.

[0008] In the claims and / or detailed description, terms such as "first," "second," "third," etc. are used to distinguish between similar elements and not necessarily to describe an order in time, space, ranking, or in any other way. It is understood that terms so used are interchangeable under appropriate circumstances and capable of operating in orders other than those described or illustrated herein.

[0009] Processes, techniques, devices, and materials known by those skilled in the art may not be described in detail, but are intended to be part of the description to an enabling extent, where appropriate.

[0010] Orientation of the x, y, and z axes in Cartesian coordinates is assumed to be such that the x and y axes define a plane at a given location and the z axis is orthogonal to the xy plane. The axes of rotation about the Cartesian axes of the device are defined as yaw, pitch, and roll. In the Cartesian coordinate orientations defined in this paragraph, the yaw rotation axis is the z axis through the body of the device. Pitch changes the orientation of the longitudinal axis of the device. Roll is rotation about the longitudinal axis of the device.

[0011] The orientation of the X, Y, and Z axes of the Cartesian coordinate system is chosen to facilitate graphical display on a computer screen with an orientation that the user can most easily relate to. Thus, whenever the device itself moves upward, for example, away from the Earth's surface, the image of the device moves upward on the computer display. The same is true for movement to the left or right.

[0012] Although inertial sensors are provided as a possible example in the description of the embodiments, any tracking device (e.g., GPS chips, acoustic ranging, accelerometers, magnetometers, gyroscopes, inclinometers, MEMS devices) can be used within the scope of the described embodiments.

[0013] At least one embodiment is directed to a motion orthopedic measurement system that assists surgeons in determining alignment, range of motion, loads, impingement, and contact points of orthopedic implants in real time. While this system is general to any orthopedic surgical procedure (e.g., spinal, shoulder, knee, hip, ankle, wrist, finger, toe, bone, musculoskeletal, etc.), the following example addresses shoulder surgery as a non-limiting example of one embodiment of the present invention.

[0014] Non-limiting embodiments described herein relate to quantitative measurement based orthopaedic surgery and are referred to herein as motion systems. The motion systems include a sensor system that provides quantitative measurement data and feedback that can be provided visually, audibly, or tactilely to a surgeon or surgical team. The motion system provides the surgeon with real-time dynamic data regarding forces, pressures, or loads on the shoulder joint, contact and compliance throughout the full range of motion, and information regarding impingement.

[0015] Generally, kinematics is the study of the action of forces in response to the movement of a body or body system. Disclosed herein is a system for kinematic assessment of the musculoskeletal system. The kinematics system can be for the placement of prosthetic components or for the monitoring and assessment of components permanently installed in the musculoskeletal system. For example, the placement of a prosthetic component may require the preparation of one or more bone surfaces to accept the device or component. The kinematics system is designed to provide quantitative measurements of at least the loads, load locations, or alignment of forces applied to the joint as well as that of the final joint placement. The sensor-equipped measurement components are designed to allow ligaments, tissues, and bones to remain in place while quantitative measurement data is acquired. This is important because the kinematics assessment, and subsequent bone cuts, take into account kinematic forces, which can significantly alter alignment, loads, and load locations when the joint is reconstructed by bone cuts.

[0016] Quantitative measurement data, combined with subjective feedback of the prosthesis to the surgeon, can aid in the placement of the prosthesis. Quantitative measurement can be used to determine adjustments to the bone, prosthetic components, or tissue before final placement. Permanent sensors can also be housed within the final prosthetic components to provide periodic data related to the condition of the implant. Data collected during surgery and over time can be used to determine parameter ranges for surgical placement and refine future prosthetic components. The one or more physical parameters of interest can include, but are not limited to, alignment, load, force, pressure, position, displacement, density, viscosity, pH, simulated acceleration, color, motion, particulate matter, structural integrity, and local temperature. Often, several measurement parameters are used to perform quantitative assessments. A graphical user interface can support the integration of measurement data. Parameters can be assessed in relation to orientation, alignment, direction, displacement, or position, as well as motion, rotation, or acceleration along one axis or a combination of axes, by wireless sensing modules or devices positioned on or within a body, equipment, appliance, medium, piece of equipment, or other physical system.

[0017] While the specification concludes with claims defining the features of the invention believed to be novel, it is believed the invention will be better understood from consideration of the following description in conjunction with the accompanying drawings in which like reference numerals carry forward.

[0018] The exemplary embodiments of the measuring devices shown below are illustrative only and do not limit use to other parts of the body. The measuring device can be a tool, instrument, implant, or prosthesis that measures at least one parameter or supports placement of a prosthetic component in the musculoskeletal system. The measuring device can be used on bones, knees, hips, ankles, spine, shoulders, hands, wrists, feet, fingers, toes, and other areas of the musculoskeletal system. In general, the principles disclosed herein are meant to be applicable for use at all locations of the musculoskeletal system.

[0019] At least one embodiment is directed to a system for adjusting or monitoring contact positions of a musculoskeletal joint for stability, the system comprising: a prosthetic component configured to rotate after being coupled to a bone; a sensored prosthesis including an articular surface, the sensored prosthesis configured to couple to the prosthetic component; a plurality of load sensors coupled to the articular surface; a position measurement system configured to measure position, tilt, rotation, or trajectory; and a remote system configured to wirelessly receive quantitative measurement data from the sensored prosthesis. The remote system is configured to display the articular surface, display the location of applied loads on the articular surface, and report impingement as the musculoskeletal joint moves through a range of motion (ROM).

[0020] In general, the joint measurement system disclosed herein is intended for and can be used with any ball-and-socket joint of the musculoskeletal system. Typically, a first bone terminates in a ball-shaped surface and fits into a second bone that includes a cup to receive the ball. The first bone is moved by muscles, tendons, ligaments, and tissues to move the first bone so that the ball of the first bone rotates within the cup of the second bone. Ball-and-socket joints have some of the widest ranges of motion of the various joints in the musculoskeletal system. For example, the shoulder joint and the hip joint are ball-and-socket joints. The shoulder joint and the hip joint are synovial joints that contain synovial fluid. The examples disclosed below relate to shoulder joint systems, such as reverse shoulder prostheses or standard shoulder prostheses. Reverse shoulder prostheses and standard shoulder prostheses include a cup and a ball as part of the joint system. The measurement device, including the electronic circuitry and sensors, can be adapted to either the curved surface of the cup or the curved surface of the ball of the shoulder joint system. All of the shoulder joint examples disclosed herein can also be used and sized for hip joints. The measurement devices disclosed herein can be adapted to the curved surface of the acetabular cup of a hip joint, or the curved surface of the ball of a femoral head.

[0021] FIG. 1 illustrates a shoulder prosthesis 100 according to an exemplary embodiment. A natural shoulder joint supports a wide range of motion (ROM) compared to other joints in the musculoskeletal system. The shoulder joint includes the humerus, scapula, anteroposterior process, acromion, and clavicle. The shoulder joint is surrounded by a synovial membrane, which produces synovial fluid, which lubricates the shoulder joint and circulates nutrients to the area. The scapula includes a glenoid cavity, which has a curved surface. The proximal end of the humerus includes the humeral head, which includes a curved surface that connects to the glenoid cavity to support motion and establish the range of motion of the shoulder joint. The humeral neck extends from the humerus and connects to the humeral head at a predetermined angle. Muscles, tendons, and ligaments connect to the humerus, scapula, and clavicle to hold the shoulder joint in place and move the humerus relative to the scapula.

[0022] The shoulder prosthesis 100 includes a humeral prosthetic material 102 and a glenoid prosthesis material 114. The humeral prosthesis 102 includes a stem 104, a neck 106, and a head 108. The head 108 has an external curved surface configured to support the motion of the shoulder prosthesis 100. In one embodiment, the external curved surface is convex. The proximal end of the humerus 110 is cut to receive the humeral prosthesis 102. The stem 104 is seated in the medullary canal of the humerus 110 and couples the humeral prosthesis 102 to the humerus 110.

[0023] The glenoid prosthesis 114 includes a glenoid structure 118 and a retention structure 116. The glenoid cavity on the scapula 112 is configured to receive the glenoid prosthesis 114. The retention structure 116 of the glenoid prosthesis 114 is configured to couple to the scapula 112 and retain the glenoid structure 118. In one embodiment, the glenoid structure 118 replaces the glenoid cavity. The glenoid structure 118 has an external curved surface. The glenoid structure 118 is configured to couple to the head 108 of the humeral prosthesis 102 and support motion of the shoulder prosthesis 100. In one embodiment, the external curved surface of the glenoid structure is concave. The external curved surface of the glenoid structure 118 is low-friction to support motion under load by the humeral prosthesis 102.

[0024] In one embodiment, the glenoid prosthesis material 114 is a testing device that includes a test measurement device. After measurements are taken using the test measurement device, the test device is removed and a permanent prosthesis is installed. Alternatively, the glenoid prosthesis material 114 can include a tray coupled to the retention structure 116. A bearing having an articular surface is configured to couple to the tray. In one embodiment, the bearing can be removed from the tray and replaced with a test measurement device. A further example is a removable humeral head 108 that can be replaced with a test measurement device. In one embodiment, the test measurement device on the humeral prosthesis material 102 can operate separately from or in combination with the test measurement device replacing the glenoid structure 118. Generally, the test measurement device includes at least one sensor configured to measure a parameter. The test measurement device has an external curvature and dimensions similar to those of the glenoid prosthesis material 114 or the humeral prosthesis material 102. In one embodiment, measurements taken by the test measurement device relate to the range of motion and stability of the shoulder prosthesis 100.

[0025] 2 is an illustration of a shoulder prosthesis 120 according to an exemplary embodiment. The shoulder prosthesis 120 is also known as a reverse shoulder prosthesis. The shoulder prosthesis 120 includes a humeral prosthetic material 122 and a glenoid prosthesis material 130. The humeral prosthesis material 122 includes a stem 124, a neck 126, and a humeral liner 128. The proximal end of the humerus 110 is cut to receive the humeral prosthesis material 122. The stem 124 is placed in the medullary canal of the humerus 110.

[0026] The glenoid prosthesis 130 includes a glenoid sphere 132 and a retention structure 134. The glenoid cavity of the scapula 112 is configured to receive the glenoid prosthesis 130. The retention structure 134 of the glenoid prosthesis 130 is configured to couple to the scapula 112 and retain and hold the glenoid sphere 132 in a position that couples to the humeral prosthesis 122. In one embodiment, the glenoid sphere 132 is configured to couple to a surface of the scapula 112 to replace the glenoid cavity. The glenoid sphere 132 has a curved surface that is configured to couple to the humeral liner 128 of the humeral prosthesis 122. The shoulder prosthesis 120 is a reverse shoulder because the glenoid sphere, which corresponds to the humeral head of the humerus, is coupled to the scapula. Additionally, the humeral liner 128, which corresponds to the glenoid cavity of the scapula 112, is instead coupled to the humerus 110. Thus, the articular surfaces are reversed. In one embodiment, the exterior curved surface of the humeral liner 128 is concave. In one embodiment, the exterior curved surface of the glenosphere 132 is convex to mate with the humeral liner 128 and support the motion of the shoulder prosthesis 120. The exterior curved surface of the humeral liner 128 is load-bearing and low-friction to support the motion of the shoulder prosthesis 120.

[0027] In one embodiment, the humeral liner 128 can be removed and replaced with a test measurement device. The test measurement device can be coupled to the neck of the humeral prosthesis material 122. For example, the neck 126 of the humeral prosthesis material 122 can terminate in a tray configured to receive the humeral liner 128. The humeral liner 128 is removable and configured to be replaced with a test measurement device. The test measurement device includes at least one sensor configured to measure a parameter. The test measurement device has a similar exterior curvature and dimensions to the humeral liner 128. In one embodiment, measurements taken by the test measurement device relate to the motion, loading, and stability of the humeral prosthesis material 122 within the shoulder prosthesis 130. In one embodiment, the glenosphere 132 can be removed and replaced with a second test measurement device including at least one sensor. In one embodiment, the second test measurement device can be used in place of the first test measurement device to evaluate the shoulder prosthesis 130. In one embodiment, both the first and second test measurement devices can be used to provide measurement data for evaluating the shoulder prosthesis 130. The final prosthetic components are installed after using the first or second test measurement devices. In one embodiment, one or more of the final prosthetic components can include at least one sensor to measure a parameter.

[0028] FIG. 3 is an illustration of a measurement device 154 in a shoulder joint system 160 according to an exemplary embodiment. In the exemplary embodiment, a reverse shoulder joint is shown in a musculoskeletal system. The shoulder joint system 160 includes a computer 162, a glenosphere 152, and a humeral prosthesis 158 including a measurement device 154. The glenosphere 152 is shown coupled to a contoured bony surface of the scapula 140. The clavicle 142 and the os scapula 144 are shown in relation to the placement of the glenosphere 152. In one embodiment, the glenoid cavity of the scapula 140 is formed to receive the glenosphere 152. As shown, the glenosphere 152 couples to the contoured bony surface 146 of the scapula 140. The glenosphere 152 may include an anchor or stem to support attachment to the scapula 140. In one embodiment, screws are used to couple the glenosphere 152 to the scapula 140. The glenosphere 152 has an outer curved surface configured to couple to the measurement device 154. In this example, the glenosphere 152 has a convex surface.

[0029] In one embodiment, a humeral prosthetic material 158 is configured to couple to the humerus 150. The proximal end of the humerus 150 is cut to have a bone surface 148 formed to receive the humeral prosthetic material 158. The humeral liner has a low-friction surface and is configured to support the motion of the shoulder joint system 160. The humeral liner is configured to couple to a humeral tray 156. In this example, the humeral liner is configured to be removable from the humeral prosthetic material 158 and is shown removed in FIG. 3 . A sizing device 154 replaces the humeral liner within the humeral tray 156. In one embodiment, the sizing device 154 is configured to be equal in size to the humeral liner. In one embodiment, the exterior curved surface of the sizing device 154 is concave and is depicted to couple to the exterior curved surface of the glenosphere 152. The measurement device 154 includes at least one sensor and electronic circuitry configured to control the measurement process and transmit measurement data to a computer 162 near the shoulder joint system 160. In one embodiment, the measurement device 154 can further include a position measurement system configured to measure position or motion. The at least one sensor measures a parameter of interest to support placement of the shoulder joint system 160. Typically, the computer 162 is located in an operating room outside the surgical field where the shoulder joint system 160 is being placed. The display 164 includes a graphical user interface (GUI) that supports presenting the measurement data in a graphical manner that allows the surgical team to quickly adapt the measurement data to verify, adjust, or make changes that improve placement.

[0030] Typically, at least one component of the shoulder joint system 160 has measurement capabilities. In this example, the shoulder joint system 160 is a reverse shoulder system having a measurement device 154. The measurement device 154 can be adapted for use with a standard shoulder joint system, including a humeral prosthetic material and a glenoid prosthetic material. Additionally, sensors can be placed on one or both of the humeral prosthetic material and the glenoid prosthetic material of a standard shoulder joint system. The measurement device 154 is not limited to shoulder arthroplasty. The measurement device 154 can be adapted for use with the hip, knee, spine, bones, ankle, wrist, fingers, toes, and other parts of the musculoskeletal system.

[0031] Quantitative measurement data is required to assess and optimize shoulder kinematics during surgery. The measurement device 154 delivers quantitative measurement data to the surgeon or surgical team in real time to assist in adjusting tensions on various soft tissues that move the shoulder and affect shoulder range of motion. In one embodiment, the measurement device 154 is a temporary, or trial, device that is substantially equivalent in size to a corresponding permanent prosthesis. The permanent prosthesis that replaces the measurement device 154 in the final prosthesis measures similarly to the measurement data provided by the measurement device 154.

[0032] The shoulder joint system 160 is measured by the measurement device 154 throughout the entire range of motion (ROM). For example, the position of the humerus 150, the magnitude of the load applied to the measurement device 154 by the glenosphere 152, and the contact point where the glenosphere 152 interfaces with the measurement device 154 can be measured in real time throughout the entire ROM. Scapular notching is a common complication in shoulder joint placement. Notching is caused by repeated contact between the humeral prosthetic material 158 and the underlying scapular neck, causing an osteolytic reaction and resulting in polyethylene debris. When impingement is detected, adjustments to the shoulder joint system 160 can be made to prevent scapular notching from occurring. The range of motion and load are monitored to determine whether tension on the various soft tissue elements that enable shoulder movement should be adjusted. Soft tissue adjustments using quantitative measurement data can reduce or eliminate impingement, increase stability at the shoulder joint, and increase the shoulder's range of motion. More specifically, these measurements are used to enhance stability by reducing implant malpositioning, improving subscapularis muscle quality, and adjusting shoulder muscle tension. Adequate soft tissue compression at the glenohumeral joint has been shown to significantly improve stability in reverse total shoulder arthroplasty. Furthermore, prosthesis designs that lateralize the humerus achieve better rotator cuff tension and more deltoid wrapping, inherently increasing stability.

[0033] FIG. 4A is a flowchart 170 for shoulder joint installation using the measuring device 154 of FIG. 3 according to an exemplary embodiment. In this example, the measuring device disclosed in flowchart 170 corresponds to measuring device 154 and is configured to fit into a humeral prosthesis. The measuring device includes at least one sensor and is configured to measure at least one parameter. In one embodiment, the measuring device transmits measurement data to a computer. The measurement data can be reviewed in real time on a display coupled to the computer. In one embodiment, the measuring device is also compatible with a tensioning device to enable function early in the procedure, such as immediately after humeral resection. The measuring device supports musculoskeletal and shoulder joint systems of various sizes, allowing a single measuring device to support a significant portion of the population. In one embodiment, the measuring device can be installed into the humeral trial and implant without special tools. Similarly, the measuring device can be removed from the humeral trial and implant without special tools.

[0034] Not all steps may be listed, for example, steps known in the art that can be used in this method. Additionally, the steps listed herein are not intended to be in any particular order and may be performed in a different order depending on the application. In step 172, the shoulder is exposed to gain access to the humerus. In step 174, the proximal end of the humerus is cut to form a humeral surface. In one embodiment, this cut is made at a predetermined angle. In one embodiment, the prepared bone surface of the humerus is configured to receive a humeral prosthesis. The stem of the humeral prosthesis is placed into the medullary cavity of the humerus and held in place. The humeral prosthesis may also include a stem protector. In step 176, a glenoid prosthesis is prepared for implantation. In one embodiment, one or more bone cuts or bone modifications are made to the scapula to receive the glenoid prosthesis. In step 178, the glenoid prosthesis is placed and bonded to the scapula. In step 180, a trial implant is bonded to the humerus. In step 182, the size of the measuring device for shoulder application is determined. In one embodiment, different sizes of measuring devices can be provided for selection. Alternatively, various adapters can be provided to assemble the measuring device to the appropriate size. In step 184, the measuring device is activated. In step 186, the measuring device is assembled for the appropriate humerus option. The measuring device is configured to be adjusted to change the humeral neck angle of the humeral prosthesis material. For example, different offsets (0, 2.5, or 5 degrees) can be selected to affect the range of motion of the shoulder joint. In step 188, the humeral tray and measuring device are coupled to the humeral stem of the humeral prosthesis material. Thus, the glenoid prosthesis material and the humeral prosthesis material including the measuring device are installed on the scapula and humerus, respectively. In step 190, the shoulder is reduced. The shoulder is in position while the measuring device transmits measurement data to a computer. A display is coupled to the computer to display the measurement data in real time to the surgeon or surgical team.

[0035] In step 192, the shoulder is evaluated through its full range of motion (ROM). In one embodiment, the shoulder is moved through one or more predetermined motions, and measurement data indicates any issues with the placement of the shoulder prosthesis. The measurement device transmits measurement data from one or more sensors within the measurement device to a computer. The measurement data is displayed to the surgeon or surgical team in real time. In one embodiment, a portion of the measurement data is processed by the computer and displayed graphically on the computer display to support rapid adaptation by the surgical team to the measurement data. In step 194, clinically appropriate adjustments are made based on the measurement data from the measurement device.

[0036] FIG. 4B is a continuation of the flowchart 170 from FIG. 4A for shoulder joint installation using the measuring device 154 of FIG. 3 in accordance with an exemplary embodiment. In step 196, the humeral tray trial implants and measuring device are removed from the humeral prosthesis material. In step 198, the humeral tray implants are installed in the humeral prosthesis material. In one embodiment, the humeral tray implant is the final implant and not the trial device. In step 200, the installation measuring device is coupled to the humeral prosthesis material. In one embodiment, the measuring device is coupled to the humeral tray implant. In one embodiment, the trial implants are similar in size to the humeral tray implants such that measurement data acquired when the measuring device was in the trial implant is substantially equivalent to measurement data acquired by the measuring device in the humeral tray. In step 202, the shoulder joint is reduced.

[0037] In step 204, the shoulder is moved through a full ROM. The measurement device transmits measurement data to a computer and displays it on a display. The measurement data is reviewed by the surgeon or surgical team to verify clinically appropriate adjustments prior to using a permanent humeral tray implant coupled to the humeral prosthesis. In one embodiment, further clinically appropriate adjustments can be made to improve or refine the shoulder joint based on the ROM results and quantitative measurement data. In step 206, the measurement device is removed from the permanent humeral tray implant. In one embodiment, the measurement device is a disposable device that is discarded after the surgery is completed. In step 208, a humeral liner is coupled to the humeral tray implant. The humeral liner has a curved surface configured to couple to the glenoid implant. The humeral liner is substantially the same size as the measurement device. The humeral liner has a low-friction surface that allows the shoulder to withstand loads applied throughout the full range of motion. In step 210, the shoulder joint is retracted. In step 212, the wound is closed with the permanent shoulder prosthetic components in place. The permanent shoulder functions equally well as it was measured and adjusted using the measuring device.

[0038] FIG. 5 is an exploded view of the measuring device 154 showing the components according to an exemplary embodiment. Generally, the measuring device 154 generates quantitative measurement data targeting clinical parameters that affect joint outcome, impingement, stability, and range of motion. In this example, the measuring device 154 is configured for use with a shoulder joint, and more specifically, a reverse shoulder joint. The measuring device 154 is configured to measure functional and maximum load ranges, which are representative of the loads seen in a reverse shoulder joint. The measuring device 154 is configured to detect and report joint forces relative to the glenosphere that couples to the humeral liner when the shoulder joint is being tested. The measuring device 154 includes sensors that detect the movement and orientation of the humeral prosthetic material. The measuring device 154 is configured to detect inferior impingement relative to the humeral liner. The measuring device 154 is configured to measure superior impingement relative to the humeral liner. The measuring device supports understanding the soft tissues coupled to the shoulder joint, which soft tissues need to be evaluated, and the results of adjusting the soft tissues. In one embodiment, the tension of different soft tissues coupled to the shoulder joint can be assessed and individually adjusted within a predetermined range that provides optimal stability. The measurement device 154 is configured to couple to a computer including a display. In one embodiment, the computer and display are located in the operating room with the surgical team in mind, reporting measurement data from the measurement device 154. Typically, the computer and display are located outside the sterile field of the operating room. The measurement device 154 includes a low-power transceiver to support communication within the operating room but support highly attenuated signals outside the operating room. Communications can be secure by encrypting transmissions to prevent measurement data from being read.

[0039] The measuring device 154 and computer provide load and motion data with minimal lag or delay. In one embodiment, the lag or delay is typically less than two seconds. In one embodiment, the measuring device 154 is designed for a single use and is provided in sterile packaging. In one embodiment, the power supply within the measuring device 154 has enough power for a single use but cannot power a second use. In one embodiment, the measuring device 154 cannot be opened to replace the power supply. In one embodiment, the functional life for the measuring device 154 is approximately one to several hours in a surgical environment. The measuring device 154 comprises biocompatible materials. In one embodiment, the measuring device 154 is tested and calibrated prior to sterile packaging to ensure optimal performance.

[0040] The measurement device 154 includes an upper housing 220 and a lower housing 222. The upper housing 220 and the lower housing 222 are configured to bond together to form a hermetically sealed enclosure. The sensor 230, electronic circuitry 236, and PC board 234 are hermetically sealed within the enclosure. In this example, the upper housing 220 has an outer curved surface 224 configured to bond to the outer curved surface of the glenosphere to support shoulder joint motion. The upper housing 220 further includes a rim 242 that bonds to the outer curved surface 224. In one embodiment, the upper housing 220 and the lower housing 222 have corresponding retention features to hold the upper housing 220 to the lower housing 222. Alternatively, screws can be positioned through the openings 226 to bond the upper housing 220 to the lower housing 222. The lower housing 222 includes an attachment structure 240 configured to bond to a humeral tray of a humeral prosthesis. Alternatively, the upper housing 220 can be bonded to the lower housing 222 using glue or an adhesive. The mounting structure 240 aligns and secures the housing relative to the humeral prosthesis material. The lower housing 222 includes an opening 254 configured to receive a structure from the upper housing 220. The opening 254 terminates in a reinforced region configured to receive a screw to hold the upper housing 220 to the lower housing 222. The flexible interconnect 228 is configured to couple to a printed circuit (PC) board 234. The flexible interconnect 228 couples the sensor 230 to an electronic circuit 236. In one embodiment, the electronic components are mounted to the PC board 234. The PC board 234 includes interconnects for coupling the electronic components to form an electronic circuit configured to control the measurement process and transmit the measurement data.

[0041] In one embodiment, the sensor 230 is formed within the flexible interconnect 228. If the sensor 230 is simultaneously formed within or on the flexible interconnect 228, it can be accurately replicated and have similar characteristics. The reference sensor 232 can also be formed within or on the flexible interconnect 228. For example, the sensor 230 can be a load sensor. The load sensor can be an elastic capacitor, a MEMS device, a mechanical structure, a hydraulic structure, an air membrane structure, a strain gauge, a transducer, or a piezoelectric structure. When coupled to a load, the load sensor converts the load into an electrical signal and provides the electrical signal to the electronic circuit 236 via the flexible interconnect 228. Alternatively, the sensor 230 can be a separate sensor coupled to the flexible interconnect 228. In this example, the load sensor 230 is an elastic capacitor, a MEMS device, or a piezoelectric structure. The sensor 230 is coupled between the upper housing 220 and the lower housing 222. In one embodiment, the sensors 230 are coupled to raised areas 238 on the inner surface 244 of the lower housing 222. The raised areas 238 each have a surface that is not flush with the inner surface 244 of the lower housing. In one embodiment, there are as many sensors 230 as there are raised areas 238. For example, three load sensors are used to measure loads applied to the outer curved surface 224. Loads applied to the surface 224 of the upper housing 226 by the glenosphere of the shoulder joint are configured to compress the sensors 230. In one embodiment, the sensors 230 can be preloaded by adjusting the screws in the openings 226 that couple the upper housing 220 to the lower housing 222 to position the sensors 230 within a linear operating range for the range of loads applied to the measuring device 154. Additionally, the measuring device 154 can be put through a calibration process to ensure optimal performance that each sensor can measure, and corrections can be applied to the sensor measurements to ensure linear operation throughout the load range. The corrections can be stored in memory and used to calibrate each sensor in the system.

[0042] FIG. 6 is an exploded side view of measurement device 154 according to an exemplary embodiment. In one embodiment, the side view shows upper housing 220 mating to lower housing 222 at an angle relative to the bottom surface of mounting structure 240. Electronic circuitry 236, PC board 234, flexible interconnect 228, and sensor 230 are contained within an enclosure formed by upper housing 220 and lower housing 222. In one embodiment, electronic circuitry 236 and PC board 234 are located within a cavity inside lower housing 222. Flexible interconnect 228 couples to a connector mounted on PC board 234, coupling sensor 230 to electronic circuitry 236. An inner surface 256 of upper housing 220 includes raised regions 252. Raised regions 252 are sensor pads configured to couple to sensor 230. Raised regions 252 each have a surface that is not flush with inner surface 256 of upper housing 220. In one embodiment, there are as many raised areas 252 as there are sensors 230 .

[0043] The upper housing 220 can be coupled to the lower housing 222 by screws, retention mechanisms, adhesives, welding, electrical means, magnetic means, or other sealing and fastening methods. The upper and lower housings 220 and 222 can comprise polymers, ceramics, metals, metal alloys, or materials capable of supporting the loads of a musculoskeletal joint and providing a low-friction surface. In one embodiment, the material comprising the upper housing 220 is low-friction, such that the outer curved surface 224 is low-friction. Alternatively, a low-friction coating can be bonded or applied to the upper housing 220 to provide a low-friction outer curved surface 224. In the example shown hereinabove, the upper housing 220 is coupled to the lower housing 222 by screws. The upper housing 220 includes a structure 250 corresponding to the opening 254 in FIG. 5 . In one embodiment, the structure 250 is cylindrical in shape. Screws placed through the openings 226 couple through the corresponding structure 250. The structure 250 is a reinforced region of the upper housing 220 configured to receive the screws. In one embodiment, structure 250 aligns upper housing 220 with lower housing 222. Upper housing 220 aligns with lower housing 222 such that structure 250 of upper housing 220 mates with opening 254 on surface 244 of lower housing 222. In one embodiment, opening 254 terminates in a reinforced region of lower housing 222. Screws mate through structure 250 into the reinforced region in lower housing 222 to hold upper housing 220 to lower housing 222. As previously described, the screws can be adjusted to seal the enclosure and preload sensor 230 for optimal performance.

[0044] 7 is an illustration of the upper housing 220 coupled to the lower housing 222 according to an exemplary embodiment. The upper housing 220 is transparent to show the underlying electronic circuitry 236, flexible interconnect 228, and sensor 230. Screws are placed within the openings 226 and couple to the lower housing 222, holding the upper housing 220 to the lower housing 222. In one embodiment, three screws are used to hold the upper housing 220 to the lower housing 222.

[0045] Sensor 230 is shown coupled to a raised region 252 of upper housing 220. Referring briefly to FIG. 6, raised region 252 is formed on inner surface 256 of upper housing 220. Referring briefly to FIG. 5, sensor 230 is also coupled to a raised region 238 on inner surface 244 of lower housing 222. In one embodiment, raised region 252 and raised region 238 have an area equal to or greater than the area of ​​sensor 230. Flexible interconnect 228 couples sensor 230 to electronic circuitry 236 within the housing. In one embodiment, sensor 230 includes three sensors configured to measure loads applied to outer curved surface 224 of upper housing 220. In one embodiment, the three sensors are equidistant from one another and located adjacent to rim 242 of upper housing 220 below outer curved surface 224. Each sensor 230 is positioned at a predetermined location on outer curved surface 224. Pressure applied to surface 224 of upper housing 220 compresses sensor 230 between raised area 252 and raised area 238 at a predetermined location. Measurement data from sensor 230 is transmitted from measurement device 154, shown in FIG. 3, to computer 162 in the operating room. Calibration data can be used to adjust the measured output of sensor 230 at measurement device 154 before transmission or at computer 162 in FIG. 3. Computer 162 includes a display 164 configured to provide information related to the measurement data. In one embodiment, computer 162 is configured to calculate a magnitude of a load at a contact point on outer curved surface 224 from the measurement data from sensor 230. In this example, the contact point is the area or region of outer curved surface 224 that couples with the glenosphere of a reverse shoulder joint. Furthermore, computer 162 calculates the contact point on outer curved surface 224 and the position of the sensor on outer curved surface 224 from the measurement data from sensor 230. In one embodiment, the measurement data can include data from a position or motion measurement system. A position or motion measurement system is part of electronic circuitry 236. In one embodiment, the position measurement system includes one or more inertial sensors. Data from the position measurement system can be used to support calculations and presentations performed by computer 162 and displayed on display 164.

[0046] To further linearize the output, the sensor 230 can be tested and calibrated before packaging and sterilizing the measurement device 154. As part of the calibration process, the sensor 230 can be preloaded by torqueing the screw at different values. Preloading the sensor 230 can support operation of the sensor 230 in a linear region of operation. Calibration data can be stored in memory as part of the electronic circuitry 236 and used to correct for nonlinearities in the sensor 230 to provide more accurate measurement data. During the calibration process, the sensor is zeroed or measures zero when the exterior curved surface 224 is unloaded.

[0047] FIG. 8 is a cross-sectional view of measurement device 154 according to an exemplary embodiment. A cavity 260 is formed when upper housing 220 is mated to lower housing 222. Electronic circuitry 236 on printed circuit board 234 is placed within cavity 260. Cavity 260 includes at least one positioning device to align and hold electronic circuitry 236 and PC board 234. In one embodiment, sensor 230 is formed within or on flexible interconnect 238. Flexible interconnect 238 is patterned or formed to hold sensor 230 in place. As shown, flexible interconnect 238 positions and couples sensor 230 between raised region 252 of upper housing 222 and raised region 238 of lower housing 222. In one embodiment, the support structure 262 may extend from the lower housing 222 towards the upper housing 220 to hold the flexible interconnect 238 centrally within the measurement device 154 .

[0048] 9 is an illustration of mechanical features of the housing of measurement device 154 according to an exemplary embodiment. Measurement device 154 includes an upper housing 220 and a lower housing 222 that form a housing for electronic circuitry and one or more sensors. As shown, upper housing 220 includes a transparent material to reveal underlying features within lower housing 222. In one embodiment, upper housing 220 and lower housing 222 include a biocompatible material. In one embodiment, upper housing 220 and lower housing 222 can be molded or 3D printed from a polymer material.

[0049] Raised regions 238 are formed on the inner surface 244 of the lower housing 222. The raised regions 238 are sensor platforms that extend above the inner surface 244 of the lower housing 222. In one embodiment, each raised region 238 couples to a corresponding sensor. In this example, three raised regions 238 are formed on the inner surface 244. In one embodiment, the sensor 230 is a capacitor approximately 4 millimeters in diameter formed within the flexible interconnect 228. In one embodiment, the capacitor may be formed by a first interconnect and a second interconnect separated by a dielectric material within the flexible interconnect 228. In one embodiment, the dielectric material may be polyimide. In one embodiment, the capacitor may be shielded to minimize capacitance or parasitic coupling of signals to the capacitor. In one embodiment, the raised regions 238 are 4 millimeters or greater to support the sensor 230. The sensor snaps 270 are cutouts on the inner surface 244 of the lower housing 222 adjacent to the raised regions 238. The notches in the sensor snaps 270 help retain the sensor 230 on the corresponding raised areas 238 .

[0050] Solder holes 272 are cutouts in lower housing 222 that accommodate interconnects used to couple the battery within the enclosure. Flex snaps 274 are retention mechanisms configured to retain flexible interconnect 228, shown in FIG. 6 , in lower housing 222. In one embodiment, flex snaps 274 include one or more posts formed on support structure 262. Flexible interconnect 228 has one or more openings corresponding to the one or more posts. Flex snaps 274 are pressed into the corresponding openings in flexible interconnect 228 to align and retain flexible interconnect 228 relative to support structure 262. In one embodiment, flexible interconnect 228 is suspended above rigid cutout 282 in lower housing 222. In one embodiment, rigid cutout 282 is a large cutout area in lower housing 222. The electronic circuit 236 and PC board 234, as shown in FIG. 8, can be placed in the rigid cutouts 282. The rigid snaps 280 are retention features configured to retain the PC board 234 to the lower housing 222. In one embodiment, the rigid snaps 280 can be one or more posts configured to mate through one or more openings in the PC board 234 to align and retain the PC board. In one embodiment, the upper and lower housings 220 and 222 include retention features to couple the upper housing 220 to the lower housing 222. In one embodiment, an O-ring is used to hermetically seal the enclosure. In one embodiment, the O-ring circumferentially couples to the lower housing 222. In one embodiment, the O-ring secures to the lower housing 222. In one embodiment, the housing snaps 278 are one or more male retention features on the exterior of the lower housing 222. The housing snaps 278 mate through one or more corresponding openings on the upper housing 220 to align and retain the upper housing 220 relative to the lower housing 222 .In one embodiment, the O-rings are made from a flexible material and, when retained by the housing snaps 278, compress to seal against the surfaces of the upper housing 220 and the lower housing 222. The flexible O-rings compress and seal against the surfaces of the upper housing 220 and the lower housing 222. The compressed O-rings apply a force that holds the housing snaps 278 in corresponding openings in the upper housing 220. The tray rim 276 is a protrusion on the lower housing 222 that couples to the humeral tray 156 of the humeral prosthesis material 158, as shown in FIG. 3 , and transfers loads applied to the measurement device 154 to the humeral tray.

[0051] FIG. 10 is a cross-sectional view of a portion of the housing showing the sensor 230 between the upper and lower housings 220, 222, according to an exemplary embodiment. In this example, the outer curved surface 224 of the upper housing 220 couples to the outer curved surface of the glenosphere 152, as shown in FIG. 3. In one embodiment, the sensor 230 is a resilient capacitance sensor integrated into the flexible interconnect 228, as shown in FIG. 7. In one embodiment, the resilient capacitance sensor is approximately 0.012 inches thick. The sensor 230 is located adjacent to the rim 242 of the upper housing 220, below the outer curved surface 224, to maximize the measurement area. The resilient capacitance sensor is engaged after assembly of the upper and lower housings 220, 222. A 0.010 inch thick gap is designed into the upper and lower housings 220, 222 to preload the sensor 230 when the upper and lower housings 220, 222 are coupled together. In one embodiment, the raised area 252 on the inner surface 256 of the upper housing 220 is flat. The sensor 230 is coupled to the raised area 252. In one embodiment, the raised area 238 on the inner surface 244 is also flat. The sensor 230 is coupled to the raised area 238. In this example, the sensor 230 is coupled between the raised areas 252 and 238 of the upper and lower housings 220 and 222, respectively, such that the sensor 230 is compressed to 0.002 inches when the upper housing 220 is coupled to the lower housing 222. It has been found that the flat surfaces of the raised areas 252 and 238 reduce the hysteresis of the sensor 230, leading to more accurate load measurements. Furthermore, it has been found that surface roughness affects the load measurements. In one embodiment, the flat surfaces are smoothed to improve measurement consistency.

[0052] FIG. 11 is a cross-sectional view of the measurement device 154 showing the outer curved surface 224 of the upper housing 220 in accordance with an exemplary embodiment. The curved surface 224 is configured to couple to the outer curved surface of the glenosphere 152, as shown in FIG. 3 . In one embodiment, the sensors 230 include three sensors located beneath the upper housing 220. The three sensors are located beneath the outer curved surface 224 near the rim 242 of the upper housing 220. The three sensors are equally spaced from each other. In one embodiment, the raised areas 252 and 238 on the upper and lower housings 220 and 222, respectively, are located near the rim 242 to position the sensors 230 as high as possible around the outer curved surface 224 of the upper housing 220. Placing the sensors 230 near the rim 242 maximizes the sensing area that can be measured on the outer curved surface 224. In one embodiment, the three sensors are positioned 44 degrees from the glenosphere axis 290. The axis 292 of the outer curved surface 224 is shown relative to the glenosphere axis 290. In this example, arrows 294 and 296 are 44 degrees from the glenosphere axis 290 and indicate the location of the sensor 230.

[0053] FIG. 12 is an illustration of a sensor snap 270 formed in the lower housing 222 according to an exemplary embodiment. The sensor snap 270 includes a notch 300 and wings 302. The sensor 230 is coupled to the lower housing 222 in a manner that prevents movement during measurement. Any movement of the sensor 230 will introduce error into the measurement data. In this example, movement of an elastic capacitor sensor formed in the flexible interconnect 228 will cause fluctuations in the capacitance measurement. In one embodiment, the wings 302 are formed in the flexible interconnect 228 on opposite sides of the sensor 230. The notch 300 is formed in the inner surface 244 of the lower housing 222. The notch 300 corresponds to the wings 302 formed near the sensor 230. The wings 302 are press-fit into the cutouts 300 to align and secure the sensor 230 on the raised areas 238 and prevent movement of the sensor 230 during measurement. Press-fitting the wings 302 into the cutouts 300 has the added benefit of reducing assembly time. As an alternative to the cutouts 300, posts can be formed extending from the inner surface 244 of the lower housing 222. The posts are formed on opposite sides of the sensor 230 in close proximity to the sensor 230. The posts mate with corresponding openings in the flexible interconnect 228 to align and secure the sensor 230 on the raised areas 238 and prevent movement of the sensor. Further means for preventing movement are to glue the sensor 230 to the raised area 238, or to glue the wings 302 into the cutout 300, or to glue both the sensor 230 and the wings 302 to the raised area 238 and the cutout 300, respectively.

[0054] 13 is a cross-sectional view of lower housing 222 showing solder holes 272, according to an exemplary embodiment. Solder holes 272 are cutouts in lower housing 222 for soldered battery connections 310 that couple to PC board 234. As shown, solder holes 272 are located below PC board 234. Soldered battery connections 310 couple battery 312 to the bottom surface of PC board 234 to provide power to electronic circuitry 236. In one embodiment, solder holes 272 allow PC board 234 to rest flat on the inner bottom surface of lower housing 222. Solder holes 272 position battery 312 and allow for coupling of flexible interconnect 223 to support structure 262.

[0055] FIG. 14 is an illustration of a support structure 262 within the lower housing 222 configured to couple to a flexible interconnect 228, according to an exemplary embodiment. In one embodiment, the support structure 262 extends from an inner bottom surface of the lower housing 222. The support structure 262 is centrally located within the rigid cutout 282, as shown in FIG. 9 . In one embodiment, the flexible interconnect 228 is rigidly coupled to the support structure 262. The support structure 262 includes flex snaps 274. The flex snaps 274 are posts extending from the support structure 262. The flexible interconnect 228 has openings corresponding to the flex snaps 274. In one embodiment, the flex snaps 274 are larger in size than or are larger than the openings in the interconnect 228. The openings in the flexible interconnect 228 are pressed onto the flex snaps 274, press-fitting the flexible interconnect into the support structure 262.

[0056] Alternatively, pins can be used to couple flexible interconnect 228 to support structure 262. Both support structure 262 and flexible interconnect 228 include openings. The pins can be used to pass through the openings in flexible interconnect 228 and couple to openings in support structure 262. In one embodiment, the pins fasten into the openings in support structure 262 as an interference fit, retaining flexible interconnect 228 to support structure 262. Alternatively, adhesive can be used to hold the pins to support structure 262.

[0057] In one embodiment, the surface of support structure 262 is not planar or parallel to the bottom surface of lower housing 222. In this example, the surface of support structure 262 positions flexible interconnect 228 at a 12.5 degree angle relative to the bottom surface of lower housing 222. This angle positions flexible interconnect 228 in a position that supports the placement of sensor 230, as shown in FIG. 7 . Support structure 262 also positions the connector of flexible interconnect 228 in a position to mate with a connector on PC board 234. In one embodiment, flexible interconnect 228 is suspended above the bottom surface of lower housing 222.

[0058] FIG. 15 is a cross-sectional view of a portion of the upper housing 220, the lower housing 222, and the humeral tray 156 according to an exemplary embodiment. In this example, the lower housing 222 couples to the humeral tray 156 of the humeral prosthesis material 158. The humeral tray 156 typically comprises a metal such as stainless steel or titanium. The lower housing 222 can include a retention mechanism that couples to a corresponding retention mechanism on the humeral tray 156 such that the measurement device 154 is retained but removable from the humeral tray 156. In this example, load on the outer curved surface 244 of the upper housing 220 is transferred to the lower housing 222 via the sensor 230, as shown in FIG. 7. The load distribution on the sensor 230 may not be uniform depending on the trajectory of the force on the outer curved surface 244. The load couples through the lower housing 222 and is distributed to the humeral tray 156.

[0059] The upper housing 220 includes a sidewall 320 configured to couple to the sidewall 328 of the lower housing 222. The sidewall 320 covers a portion of the sidewall 328 of the lower housing 222 when the upper housing 220 is coupled to the lower housing 222. In one embodiment, the lower housing 222 includes an O-ring 322 fitted around a circumferential groove in the sidewall 328 of the lower housing 222. The O-ring 322 is configured to hermetically seal the housing. In one embodiment, the O-ring 322 is compressed when the sidewall 320 of the upper housing 220 covers the sidewall 328 of the lower housing 222. As described above, coupling the upper housing 220 to the lower housing 222 preloads the sensor 230, which corresponds to the unloaded outer curved surface 244.

[0060] The side wall 328 of the lower housing 222 may include a protrusion 325 extending partially or circumferentially from the side wall 328. In one embodiment, a first shelf of the protrusion 325 couples to the side wall 320 of the upper housing 220 from above the protrusion 325. In one embodiment, a second shelf of the protrusion 325 couples to the rim 330 of the humeral tray 156 from below the protrusion 325. In one embodiment, load is applied to the outer curved surface 244 via a load sensor and from the side wall 328 of the lower housing 222 to the rim 330 and the surface of the humeral tray 156, distributing the load applied to the measurement device 154 and the humeral prosthesis material 158. The humeral tray 156 may include an O-ring 332 that aligns, retains, and seals a portion of the lower housing 222 relative to the humeral tray 156. In one embodiment, the lower housing 222 can include a corresponding groove that receives the O-ring 332 when the metering device 154 is pressed into the humeral tray 156 .

[0061] 16 is an illustration of housing snaps 278 on the metering device 154 that couple the upper housing 220 to the lower housing 222, according to an exemplary embodiment. The housing snaps 278 include protrusions extending from the side walls 328 of the lower housing 222. In one embodiment, the side walls 320 of the upper housing 220 are designed to flex. In one embodiment, the side walls 320 have openings configured to receive the housing snaps 278 and retain the upper housing 220 to the lower housing 222. In one embodiment, the upper housing 220 slides over the lower housing 222 such that the side walls 320 of the upper housing 220 cover the side walls 328 of the lower housing 222. The upper and lower housings 220 and 222 are compressed together until the housing snaps 278 on the side walls 328 couple through corresponding openings in the side walls 320 of the upper housing 220. In one embodiment, the housing snaps 278 include angled or beveled walls 340 that facilitate the side walls 320 flexing and sliding over the protrusions until the housing snaps 278 engage with corresponding openings. In one embodiment, more than one housing snap 278 is used to retain the upper housing 220 to the lower housing 222. Alternatively, the upper housing 220 can be screwed to the lower housing 222, as disclosed in Figures 5-7.

[0062] FIG. 17 is an illustration of rigid snaps 280 extending from lower housing 222 according to an exemplary embodiment. Rigid snaps 280 are press-fit posts extending from the interior bottom surface of lower housing 222. In one embodiment, rigid snaps 280 correspond to small-sized openings in PC board 234. In this example, PC board 234 is a multi-layer rigid printed circuit board that interconnects electronic circuits 236 to form a circuit or system that controls the measurement process and transmits measurements from measurement device 154. Rigid snaps 280 align with the openings in PC board 234. Pressure is applied to PC board 234 until rigid snaps 280 couple through the corresponding openings in PC board 234. Rigid snaps 280 align and retain PC board 234 within the enclosure. More specifically, the rigid snaps 280 prevent movement of the PC board 234 while in the shoulder joint. Movement of the PC board 234 can affect the measurements by imparting movement to the leads or to the flexible interconnects that couple to the PC board 234.

[0063] FIG. 18 is an illustration of an O-ring 322 in a metering device 154 according to an exemplary embodiment. The lower housing 222 includes a rim 352. A sidewall 328 of the lower housing 222 may include a groove 350 around the perimeter to retain the O-ring 322 below the rim 352. In one embodiment, the O-ring 322 has a durometer of approximately Shore 40. As shown in FIG. 15 , when the upper housing 220 is mated to the lower housing 222, the rim 242 of the upper housing 220 covers the O-ring 322. The O-ring 322 hermetically seals the housing and prevents infiltration of gases, liquids, or solids into the metering device 154. Load measurements by the metering device 154 are not affected by the O-ring 322.

[0064] FIG. 19 is an illustration of the lower housing 222 including the electronic circuitry 236 according to an exemplary embodiment. In one embodiment, the PC board 234 is a rigid printed circuit board that is coupled to the inner bottom surface of the lower housing 222 via rigid snaps 280. The electronic circuitry 236 includes electronic components such as processors, digital signal processors, digital logic circuits, interface circuits, analog circuits, buffers, amplifiers, high-frequency circuits, sensors, passive components, and other circuits. The electronic components may be mounted on the PC board 234. The PC board 234 includes multi-layer interconnects that couple the electronic components together to form circuits that control the measurement process and transmit measurement data. A flexible interconnect 228 couples the sensor 230 to the PC board 234. In one embodiment, the flexible interconnect 228 is suspended above the PC board 234 and couples to a flex plug 362 that is mounted on the PC board 234. Flex snaps 274 couple through openings in flexible interconnect 228 to hold, align, and prevent movement of flexible interconnect 228. Flexible interconnect 228 does not include any angled bends, as angled bends have been observed to cause sensor anomalies and erroneous data. In one embodiment, flexible interconnect 228 includes a shielding layer 374 to shield sensor 230 and the interconnect. The shielding layer 374 is a ground copper layer that is external to the sensor ground and has shown significant noise improvement. Flexible interconnect 228 includes a plug 372 that couples to a flex plug 362 that couples to PC board 234. Flex plug 362 couples sensor 230 to electronic circuit 236. The battery 312 couples to the PC board 234 via interconnects 310 located underneath the PC board 234 in solder holes 312, as shown in FIG. 13. In one embodiment, the battery 312 is configured to power the measurement device 154 for a single operation. The antenna 360 couples to the transceiver circuitry on the PC board 234. The antenna 360 transmits measurement data from the measurement device 154 in the operating room to a computer 162, as shown in FIG. 3, providing the measurement data for real-time use by the surgeon.In one embodiment, the measurement device 154 is disposed of in an appropriate manner after shoulder surgery is completed.

[0065] FIG. 20 is an illustration of a flexible interconnect 228 according to an exemplary embodiment. The flexible interconnect 228 includes a sensor 230 configured to measure a force, pressure, or load applied to a measurement device. The sensor 230 can be coupled to or formed as part of the flexible interconnect 228. In one embodiment, the sensor 230 is a capacitor formed within the flexible interconnect 228 using two or more layers of interconnect. These capacitors include a first metal region and a second metal region separated by a dielectric material. In one embodiment, the capacitor is shielded to prevent noise coupling and reduce parasitic coupling. In one embodiment, the capacitor includes more than one capacitor coupled in series or in parallel. In one embodiment, the capacitor can include more than one dielectric layer. Generally, the capacitor is elastic throughout the range of motion seen by the shoulder joint. The sensor 230 is coupled to the plug 372 by an interconnect within the flexible interconnect 228. The plug 372 is configured to couple to a flex plug 362 on the PC board 234, as shown in FIG. 19 . In one embodiment, one or more reference sensors 370 are coupled to or formed within the flexible interconnect 228. The reference sensors 370 are not configured to measure loads applied to the measurement device. The reference sensors 370 are formed similarly to the sensors 230. In one embodiment, the reference sensors 370 are located near the sensors 230 to provide robust temperature and noise compensation for the sensors 230. If a single reference sensor 370 is used, the sensor can be positioned in an area substantially equidistant from the sensors 370. Alternatively, the single reference sensor 370 can be positioned proximate to one of the sensors 370. In one embodiment, there is a reference sensor 370 for each sensor 230.

[0066] FIG. 21 is an illustration of a measuring device 154 according to an exemplary embodiment. Generally, loads applied by prosthetic components coupled to the outer curved surface 224 do not include a path to ground except through multiple sensors measuring the load within the measuring device 154. In one embodiment, there are no parallel paths for applying or discharging loads to the measuring device 154. The measuring device 154 is designed to operate under the maximum load applied to the outer curved surface 224 during or at the time of installation within the prosthesis. The compressive strength of the measuring device 154 can tolerate the maximum load without affecting the load path and can tolerate the maximum load without plastic deformation. In one embodiment, the measuring device 154 is configured to withstand torque applied during reduction of the humerus. The measuring device 154 has a form factor that matches the target trial implant for the prosthesis.

[0067] The upper housing 220 is coupled to the lower housing 222 to form an enclosure for housing a power source, electronic circuitry, and one or more sensors. The power source can be a passive storage device, a battery, or other power supply. Alternatively, power can be hardwired, inductively coupled, or RF coupled to the measurement device 154. The power source has sufficient energy to power the electronic circuitry and sensors for a single joint arthroplasty procedure. One or more housing snaps 278 on the side walls 328 of the lower housing 222 fit through openings in the side walls 320 of the upper housing 220 to secure the upper housing 220. The housing snaps 278 include angled or beveled walls 340 that facilitate the side walls 320 of the upper housing 220 to flex and slide over the housing snaps 278 until the housing snaps 278 fit through openings in the side walls 320 of the upper housing 220 to secure the upper housing 220 to the lower housing 222. In this example, the housing snaps 278 are configured to hold the housing 220 in close proximity to the sensor engagement portion without applying a load when coupled to the housing 222.

[0068] In this example, the measuring device 154 is coupled to a humeral prosthetic. The outer curved surface 224 is coupled to a glenosphere, which is coupled to the scapula, to support shoulder movement. In one embodiment, the measuring device uses three sensors to measure the load and load location on the outer curved surface 224. In one embodiment, at least one reference sensor can also be used to improve the accuracy of the load measurements from each sensor. The interface between the outer curved surface 224 and the sensor 230 is fully constrained. In one embodiment, the sensing configuration of the measuring device 154 uses exactly three load sensors for full constraint when the sensor 230 is oriented at the center of curvature of the outer curved surface 224 so that all force vectors pass through the same point without moments to balance. In one embodiment, the measuring device 154 measures loads applied to the outer curved surface 224 within a range of 10 to 60 lb for shoulder applications. The accuracy of the measured load magnitude is 3.5 lb or better. In one embodiment, the range and accuracy can be adjusted by varying capacitor sensor parameters such as the dielectric thickness or sensor area. The measured capacitance value correlates to the load applied to the external curved surface 224. Alternatively, a different sensor type, such as a MEMS, strain gauge, or piezoelectric sensor, can be used instead of a capacitor. The measurement device 154 can operate with a safe overload of 200 percent of the maximum load range. In this example, the location of the applied load, or contact point, of the glenosphere on the external curved surface 224 has an accuracy of 2 millimeters and 2 degrees or better. This accuracy is provided for reference and can be changed or improved depending on the application and requirements of the measurement device. The shoulder joint can move through its full range of motion, and the measurement device 154 provides measurement data in real time. The measurement data is transmitted to an operating room computer 162, which receives and processes the measurement data and displays it on a display 164 in a format that the surgeon and surgical team can quickly adapt to, supporting validation or adjustment using the quantitative measurement data.

[0069] FIG. 22A is an illustration of a GUI 380 on the display 164 of the computer 162 according to an exemplary embodiment. The measurement device 154 resides within the shoulder joint and transmits measurement data as shown in FIG. 3. Components of FIGS. 3, 7, 8, 9, and 21 are referenced herein in the following discussion to relate the operation of the measurement device 154 to what is displayed in the GUI 380. Generally, the surgeon moves the shoulder through a free range of motion, generates measurement data, and determines the stability of the shoulder joint. Measurement data from sensors within the measurement device 154 is transmitted to the computer 162. The computer 162 processes and displays the information in a manner that allows the surgeon or surgical team to quickly adapt the quantitative measurement data. The measurement data can be displayed or presented graphically or audibly.

[0070] A photograph of a portion of the measurement device 154 is displayed on the display 164. In this example, as shown in FIG. 21 , a surface 384 corresponding to the outer curved surface 224 is displayed on the display 164. In one embodiment, the display 164 depicts the curved surface of the ball or socket of the prosthetic joint system. In one embodiment, radial measurement data from load sensors at predetermined locations, such as those disclosed herein in FIGS. 29A through 31 below, is used to determine the contact point 384 on the display 164. In other words, the movement of the contact point 384 is not measured, depicted, or calculated for the display 164 as a planar measurement, but rather illustrates the movement on the curved surface. The display 164 can further add measurement data or graphics to disclose the movement of the contact point 384 on the outer curved surface 224. In one embodiment, the movement of the contact point 384 is nonlinear. In one embodiment, the display 164 can display a three-dimensional type animation to show the surgeon or surgical team the location of the contact point 384 on the outer curved surface 224. This allows the surgeon to understand the load or location on the ball or cup of the prosthetic joint system. Alternatively, more than one view or different orientations of the outer curved surface 224 can be provided on the display 164 to better illustrate the location of the contact point 384 on the outer curved surface 224. In a reverse shoulder joint, the outer curved surface 224 interfaces with the glenosphere. The contact point 382 or load center location where the glenosphere applies load to the outer curved surface 224 of the measurement device 154 is depicted on the GUI 380. The contact point 382 is shown on a surface 384 of the GUI 380. A display box 386 discloses the load magnitude in real time on the GUI 380 as the shoulder joint moves through its range of motion. In one embodiment, the computer 162 or measurement device 154 includes software with force location and load magnitude algorithms that calculate the contact point 382 and load magnitude displayed in the display box 386 from measurement data received from the measurement device 154. In this example, the measurement data includes information from three sensors that measure loads applied to the exterior curved surface 224, at least one reference sensor, and a position measurement system configured to measure position or movement.In one embodiment, the position measurement system is configured to be housed in the measurement device 154. In one embodiment, the position measurement system is an inertial measurement unit (IMU). The computer 162 or the measurement device 154 may further include quaternion and range-of-motion algorithms to support the measurement of motion and position. Calibration information for the IMU or load sensor may be accessed, and the force position, load magnitude, and impingement measurements may be used in this calibration information. In one embodiment, the calibration information or data corresponds to test measurements on the measurement device 154. In one embodiment, the calibration data may be stored in non-volatile memory, such as an EEPROM, in the measurement device 154. As the shoulder joint moves through a predetermined range of motion, there is a minimum load magnitude measured at a first location and a maximum load magnitude measured at a second location on the surface 384 for the predetermined range of motion. The minimum load magnitude is shown in a display box 388 of the GUI 380 and is continuously updated as low values ​​occur. Similarly, the maximum load magnitude is shown in a display box 390 of the GUI 380 and is continuously updated. In one embodiment, the force vector data can be used to detect impingement. The GUI 380 notifies the surgeon or surgical team by audible, visual, or tactile means when impingement is detected. In one embodiment, an IMU includes one or more inertial sensors and is housed within the measurement device 154. The IMU can track position, movement, and can be used in combination with the force vector data or alone to determine impingement.

[0071] In this example, an end button 492, a log button 494, a zero button 496, a reset button 392, and a ROM button 470 are provided on GUI 380. In one embodiment, end button 492 toggles between connecting and disconnecting measurement device 154 from computer 162. In one embodiment, end button 492 is displayed when measurement device 154 is coupled to computer 162. In one embodiment, activating log button 494 logs data for 10 seconds. In one embodiment, activating zero button 496 zeros the load data offset. In one embodiment, activating reset button 392 resets display box 388 and display box 390 to the current load magnitude value. In one embodiment, activating ROM button 370 initiates a range of motion test. ROM button 370 further initializes the IMU for a range of motion test. Battery indicator 526 indicates the amount of power remaining in the power source. In this example, the power source is one or more batteries, and the battery indicator 526 indicates the percentage of power remaining in the measurement device's 154 batteries or provides an estimate of the measurement device's 154 operating time based on the average current drawn from the batteries. Additionally, the GUI 380 includes a tracking feature that displays the dynamic movement of the contacts 382 through a full range of motion to assess joint mobility. The GUI 380 can also show or leave a position trace where the load exceeds a predetermined threshold.

[0072] 22B is an illustration of a GUI 380 showing impingement in accordance with an exemplary embodiment. Components of FIGS. 3, 7, 8, 9, and 21 are referenced herein in the following discussion to relate the operation of the measurement device 154 to what is displayed on the GUI 380. The GUI 380 shows contact points 382 on a surface 384 that correspond to contact points on the surface 224 of the measurement device 154. In this example, the contact points 382 are calculated from quantitative measurement data from the measurement device 154 and are updated in real time as the shoulder joint moves through its range of motion.

[0073] The measurement device 154 couples to the computer 162, which can be displayed on the GUI 380. An indicator 528 on the GUI 380 indicates the signal strength of the wireless connection to the measurement device 154. The signal strength is displayed on the indicator 528, which provides an indication of the connection and the ability to transfer measurement data to the computer 162. In one embodiment, the wireless connection is a Bluetooth low energy connection, which opens a connection dialog between the computer 162 and any Bluetooth device. The computer 162 is used to select the measurement device 154 for connection and initiate the wireless connection. In one embodiment, calibration data and device information from the measurement device 154 are downloaded to the computer 162. The measurement device 154 couples to the computer 162 and begins streaming measurement data. In one embodiment, the GUI 380 begins showing the magnitude of the load measured at the node 382 in a display box 386 following zeroing any load data.

[0074] In a first step, the ROM button 470 is enabled in preparation for the measurement device 154 to measure the shoulder joint as it moves through a predetermined range of motion. The position measurement system is enabled for measurement. In this example, the position measurement system is an inertial measurement unit. In a second step, the shoulder joint is held stationary at 0 degrees of adduction for 5 seconds. In a third step, the GUI 380 is configured to display a notification to begin movement in abduction. In a fourth step, the rotation degrees and plots are updated during the movement. In a fifth step, at the end of the movement (e.g., full abduction), the user holds the arm stationary. In a sixth step, measurement data is captured during the movement, and the ROM button 470 indicates that the measurement is complete. In one embodiment, the ROM button 470 changes color when the measurement is complete.

[0075] Impingement occurs when a prosthesis impinges on bone or soft tissue. In this example, scapular notching occurs when a shoulder prosthesis impinges on bone at a point within the range of motion. Scapular notching typically occurs during adduction. Impingement can also occur in the soft tissue surrounding the shoulder prosthesis. Soft tissue impingement is often referred to as acromion impingement. Impingement information can be displayed on the GUI 380. In one embodiment, a rim 520 is used to indicate whether impingement is occurring and the approximate location where it will occur. A portion of the rim 520 is highlighted by a color or grayscale change on the portion of the rim 520 proximate the location where the impingement will occur. In one embodiment, when impingement is detected, the portion of the rim 520 proximate the impingement turns red. In one embodiment, a plot 522 is displayed on the GUI 380. The plot 522 shows the angle of range of motion versus load for the contact point 382.

[0076] FIG. 23 is an illustration of a GUI 380 on a display 164 coupled to a computer 162 displaying sensor information related to range of motion from a measurement device 154, according to an exemplary embodiment. In this example, the measurement device 154 is in a reverse shoulder joint, as shown in FIG. 3. Components of FIGS. 3, 7, 8, 9, and 21 are referenced herein in the following discussion to correlate the operation of the measurement device 154 to what is displayed on the GUI 380. The measurement data includes data from a sensor 230 coupled at a predetermined location within the measurement device 154 to measure a load applied to the outer curved surface 224. In one embodiment, the predetermined location of the sensor 230 is used to calculate the location and magnitude of the load applied to the outer curved surface 224. In one embodiment, the measurement data can further include information from a position measurement system. In one embodiment, the position measurement system includes one or more inertial measurement units to track position and movement.

[0077] The computer 162 converts the measurement data from the measurement device 154 into a graphical format that allows the surgeon or surgical team to quickly assess the condition of the shoulder joint. Display boxes on the GUI 380 can be used to provide numerical information related to the parameter measurements. In this example, the shoulder joint can move through a specific range of motion, or a predetermined range of motion. A motion bar is used to provide information about the predetermined range of motion. The motion bar is a tool in the GUI 380 that allows the surgeon to quickly evaluate this motion to determine whether the shoulder joint is functioning according to known criteria or to use further optimization to affect loading or range of motion. Alternatively, a circular graphic can be used with a rim and an indicator that rotates around it to read the angle. As shown, four motion bars are displayed on the GUI 380. Each motion bar corresponds to a specific motion of the shoulder joint. In this shoulder example, each motion bar indicates the maximum range of motion for medial and lateral motion for the specific motion. As shown, the maximum value for medial motion is indicated to the left of the motion bar, and the numerical value for maximum medial motion is listed below the motion bar to the left. The maximum lateral movement value is indicated to the right of the motion bar, and the numerical value for the maximum lateral movement is listed below the motion bar to the right. The midpoint between the medial and lateral movements, or zero, is indicated by a bar in the center of the motion bar. Generally, the actual range of motion when the surgeon moves the installed prosthesis with the measuring device 154 is less than the maximum medial movement or the maximum lateral movement. A first display box indicates the numerical value of the magnitude of the load applied to the measuring device 154. A second display box indicates the maximum range of motion (in degrees) achieved by the medial movement of the prosthesis (by the surgeon) relative to the maximum medial movement. The second display box is located above the motion bar on the left side of the motion bar. A third display box indicates the maximum range of motion (in degrees) achieved by the lateral movement of the prosthesis (by the surgeon) relative to the maximum lateral movement. The third display box is located above the motion bar on the right side of the motion bar.

[0078] The motion bar in GUI 380 graphically displays the same information as the display box, but in a quickly adaptable manner to reduce evaluation time. In one embodiment, the surgeon can use the motion bar to determine whether the load and range of motion are within an acceptable range without looking at numerical values. As previously described, the length of the motion bar indicates the maximum values ​​in the range from maximum medial motion to maximum lateral motion. The surgeon's range of motion of the prosthesis can be indicated by a color scale region in the motion bar. The surgeon's range of motion can also be indicated by a gray scale region in the motion bar. A color scale can be used in the motion bar to indicate the magnitude of the load at various points within the range of motion. The color scale can be a magnitude of the load or correspond to a predetermined range of load magnitudes throughout the range of motion. Similarly, gray in the gray scale region can indicate the magnitude of the load. Each shade of gray can be a magnitude of the load or correspond to a predetermined range of load magnitudes. In one embodiment, the surgeon does not need to know the absolute value of the load magnitude at each point throughout the range of motion, but needs to know that the load magnitude is within a predetermined range throughout the range of motion. The surgeon can determine "at a glance" that the colors in the motion bar are correct or that the load or range of motion is incorrect. In one embodiment, the colors or color scale correspond to a predetermined range of acceptable load magnitudes for the shoulder joint based on clinical evidence that provides optimal performance. In one embodiment, the colors or gray shades displayed in the motion bar indicate the pattern the surgeon is looking for across the specific motion of the prosthesis. For example, the color or gray scale can change as the motion moves to maximum medial or lateral motion. For example, the surgeon can see a gray scale indicating optimal loads across a predetermined range centered between medial and lateral motion. Moving outside the predetermined range toward maximum medial motion or maximum lateral motion results in either an increased or decreased suboptimal load.Generally, the surgeon can determine at a glance where optimal load occurs and where that load is located within the range of motion. The motion bar can also indicate load or range of motion issues that need to be addressed. For example, adjustments can be made if the load is asymmetric around the medial / lateral center of motion, or if the optimal load range does not extend across a sufficient range of motion, or if there are load issues at the extreme ends. Alternatively, colors or gray shades can be selected to allow the surgeon to quickly assess where the load magnitude is outside of a predetermined range and at what point during the motion (e.g., medial or lateral motion) the load magnitude is outside of the predetermined range. For example, green can indicate that the load magnitude is within the predetermined range; yellow / orange can indicate that the load magnitude is bordering on the outside of the predetermined range; red can indicate that the load magnitude is higher than acceptable; and blue can indicate that the load magnitude is lower than acceptable. Thus, without having to review the numbers, the surgeon can determine at a glance whether the load magnitude across the range of motion is acceptable or needs to be adjusted. The surgeon can then make adjustments such as soft tissue tension, bone surface modification, implant position modification, or implant shimming, to name just a few, to change the magnitude of the load so that it is within a predetermined range.

[0079] Typically, surgeons seek to achieve an acceptable range of motion for the medial and lateral motion of a particular joint. In one embodiment, the acceptable range of motion can be indicated by dashed lines on the motion bar. A first dashed line is indicated on the medial motion side of the bar. A second dashed line is indicated on the lateral motion side of the bar. By glancing at the motion bar, the surgeon can determine whether the color or gray scale area is above the dashed line or below the acceptable range of motion (defined by the dashed line) for the medial or lateral motion of the joint. Thus, the GUI 380 supports a quick assessment of joint status as it relates to range of motion and loads across the range of motion. In one embodiment, the computer 162 can analyze the measurement data for kinematic evaluation of the prosthetic joint and provide a detailed workflow of corrections or adjustments to achieve the desired range of motion and loads.

[0080] In this example of a shoulder joint, ROM button 470 is activated on GUI 380 to initiate a range of motion measurement. Display 164 can be operated via a touchscreen, remote control, audio control, keyboard, or other device. In this example, GUI 380 displays four motion bars on display 164 after ROM button 470 is activated. The four motion bars are motion bar 400, motion bar 402, motion bar 404, and motion bar 406. Each motion bar includes a start / stop button to begin or stop a measurement. While four motion bars are shown in this example, more or fewer can be displayed depending on the application or type of joint. In this example, motion bar 400, motion bar 402, motion bar 404, and motion bar 406 include start / stop button 430, start / stop button 432, start / stop button 434, and start / stop button 436, respectively. Each motion bar represents a type of motion for the prosthetic shoulder joint being measured. Motion bar 400 represents movement involving internal / external rotation at zero degrees of abduction. Motion bar 402 represents movement involving internal / external rotation at 45 degrees of abduction. Motion bar 404 represents movement involving internal / external rotation at zero degrees of adduction. Motion bar 406 represents movement of the shoulder joint during extension and flexion.

[0081] In this example, the start / stop button 432 is enabled to begin a measurement. In one embodiment, when the start / stop button 432 is enabled, all other range of motion tests are disabled. In one embodiment, starting a new test resets or starts over a completed test. A bar 426 is displayed across the motion bar 402 to indicate the position of the shoulder joint within the range of motion of the selected movement. The shoulder joint moves through internal rotation / external rotation at 45 degrees of abduction. The GUI 380 further includes display boxes 414 and 416 near and above the motion bar 402. The GUI 380 also displays maximum internal rotation (70 degrees) and maximum external rotation (90 degrees), respectively, at the left and right ends below the motion bar 402. In reality, maximum rotation or maximum motion in both internal and external directions is often not achievable for joint placement. The allowable range of motion for the installed shoulder joint is indicated by dashed line 444, which corresponds to internal rotation of the shoulder joint at 45 degrees of abduction, and dashed line 446, which corresponds to external rotation of the shoulder joint at 45 degrees of abduction. The actual measured range of motion from medial to lateral corresponds to a color scale or grayscale area 462 within the motion bar 402. Note that grayscale area 462 covers dashed line 444 on the left side of the motion bar 402 and dashed line 446 on the right side of the motion bar 402. Grayscale area 462 indicates that the installed prosthetic shoulder joint has an allowable range of motion for internal rotation / external rotation at 45 degrees of abduction. Grayscale area 462 also indicates the load across the range of motion of the shoulder joint at 45 degrees of abduction. The load being applied to the current position is also shown in display box 428. The grayscale used for grayscale area 462 indicates the load at different points within the range of motion. The surgeon can quickly review the grayscale area 462 to determine whether the loading around the center of motion between internal and external rotation is correct, whether the loading is correct for a sufficient range of motion around the center of motion, and how the loading behaves or transitions through to maximum internal and maximum external rotation of the shoulder joint. The surgeon can then make adjustments that change the loading profile and range of motion indicated by the motion bar 402.As previously described, the computer 162 can provide a workflow that provides adjustments that can be monitored in real time, and these adjustments result in changes to the measurement data associated with the motion bar 402 to produce more optimal loads and ranges of motion.

[0082] Motion bars 400, 404, and 406 are disabled during shoulder range of motion measurement for internal rotation / external rotation at 45 degrees of abduction for motion bar 402 of GUI 380. Motion bar 400 measures shoulder range of motion with internal rotation / external rotation at zero degrees of abduction when start / stop button 430 is enabled. In this example, maximum internal rotation is 70 degrees and maximum external rotation is 80 degrees for motion bar 400. Dashed lines 440 and 442 indicate the allowable range of motion for internal rotation / external rotation at zero degrees of abduction, respectively. Dashed line 440 connects the entire left side of motion bar 400, which corresponds to internal rotation. Dashed line 442 connects the entire right side of motion bar 400, which corresponds to external rotation. A color scale or grayscale area 460 is shown on motion bar 400. The measured range of motion for internal rotation at zero degrees of adduction is shown in display box 410 of GUI 380. Similarly, the measured range of motion for external rotation at zero degrees of abduction is shown in display box 412 .

[0083] The motion bar 404 measures the range of motion of the shoulder with internal rotation / external rotation at zero degrees of adduction when the start / stop button 434 is enabled. In this example, maximum internal rotation is 70 degrees and maximum external rotation is 90 degrees for the motion bar 404. Dashed lines 448 and 450 indicate the allowable range of motion for internal rotation / external rotation at zero degrees of adduction, respectively. Dashed line 448 connects the entire left side of the motion bar 404, which corresponds to internal rotation. Dashed line 450 connects the entire right side of the motion bar 400, which corresponds to external rotation. A color scale or grayscale area 464 is shown on the motion bar 404. The measured range of motion for internal rotation at zero degrees of adduction is shown in display box 418 of the GUI 380. Similarly, the measured range of motion for external rotation at zero degrees of adduction is shown in display box 420.

[0084] The motion bar 408 measures the range of motion of the shoulder during extension and flexion when the start / stop button 436 is activated. In this example, the maximum extension for the motion bar 408 is 45 degrees, and the maximum flexion is 175 degrees. Dashed lines 452 and 454 indicate the allowable range of motion for shoulder extension and flexion, respectively. Dashed line 452 connects the entire left side of the motion bar 408 corresponding to the shoulder joint during extension. Dashed line 454 connects the entire right side of the motion bar 408 corresponding to the shoulder joint during flexion. A color scale or grayscale area 466 is shown in the motion bar 408. The measured range of motion of the shoulder joint during extension is shown in display box 422 of the GUI 380. Similarly, the measured range of motion of the shoulder joint during flexion is shown in display box 424.

[0085] FIG. 24 is an illustration of an options screen 482 in accordance with an exemplary embodiment. With brief reference to FIG. 23, pressing the options button 480 on GUI 380 returns the options screen 482. The options screen 482 allows the user to change the color scale 472 or grayscale area in the motion bar 474, which associates the color scale 472 or grayscale with the measured joint load. Display boxes 476 and 478 indicate the low and high load values ​​for the color scale 472 or grayscale area, respectively. In one embodiment, there are four values ​​for setting the load range for each color or gray shade. In one embodiment, if a gradient map is selected to indicate load, the used or acceptable load value is the midpoint of the color range 472 or grayscale. In one embodiment, if a solid map is selected to indicate load, the used value represents the maximum load for that color range or grayscale. The selected color scale 472 or grayscale range takes effect after exiting the options screen 482. In one embodiment, a retry results in the motion bar 474 being redrawn with the new color range or grayscale entered into the options screen 384 after the back button 470 is activated.

[0086] FIG. 25 is an illustration of a range of motion (ROM) overlay 390 on the GUI 380, according to an exemplary embodiment. With brief reference to FIG. 23, measurement data is acquired and stored for the shoulder joint through four different motions. Activating the display ROM button 490 displays the ROM overlay 390. In this example, the GUI 380 graphically displays the movement of a contact point 382 on the exterior surface 384 of the GUI 380 for each of the four different shoulder joint motions measured in FIG. 23. As previously described, the contact point 382 corresponds to the contact point of the glenosphere on the exterior surface 224 of the shoulder joint. The contact point 382 is calculated from measurement data from a load sensor or IMU within the measurement device 154, as shown in FIG. 21. The movement of the contact point 382 for a given motion is referred to as the load track. In one embodiment, this is not an active screen or real-time measurement. The ROM overlay 390 uses stored measurement data from each motion. The load track 500 corresponds to the internal and external motions at zero degrees of abduction. Load track 502 corresponds to medial and lateral motion at 45 degrees of abduction. Load track 504 corresponds to medial and lateral motion at zero degrees of adduction. Load track 506 corresponds to motion during extension and flexion of the shoulder joint. Thus, the movement of contact point 382 can be understood for each different motion measured, and measurements of this different motion can be used to determine whether there may be issues with the movement pattern and magnitude of load at specific points during movement. In one embodiment, load values ​​can be indicated across the load tracks by a color scale or grayscale shade. In one embodiment, computer 162 can analyze the load tracks and provide a workflow to correct or optimize the shoulder joint based on the quantitative measurement data.

[0087] FIG. 26 is an illustration of a GUI 380 showing impingement range of motion assessment according to an exemplary embodiment. Activating the I-ROM button 512 generates a graph 514 in which a trace 510 is continuously active. In one embodiment, the arm and shoulder joint are moved in a "windmill" motion. The trace 510 corresponds to the position of the humerus for adduction (graph Y-axis, humerus Z-axis) and horizontal flexion (graph X-axis, humerus Y-axis) are rendered. The track button 516 can be toggled to collect trace data or reset the trace for new data collection. In one embodiment, the measurement ignores internal / external rotation of the arm. Additionally, the area covered by the trace 510 is the limit of abduction / adduction and horizontal flexion.

[0088] FIG. 27A is an illustration of measurement data from the measurement device 154, according to an exemplary embodiment. FIG. 27B is an illustration of the measurement device 154 transmitting measurement data to a computer 162 and displaying the measurement data on a display 164, according to an exemplary embodiment. The display 164 includes a GUI 380 to support rapid adaptation of the measurement data. The housing 220 is made transparent to show the placement of the electronic circuit 236 and sensors 530, 532, and 534. The sensors 530, 532, and 534 are located below the outer curved surface 224 of the housing 220. In one embodiment, the measurement device 154 exhibits orientations such as a superior position 580, a inferior position 582, an anterior position 586, and a posterior position 584 when positioned at the shoulder joint. The sensor sheet is configured to orient the sensors 530, 532, and 534 toward the center of curvature of the outer curved surface 224. Sensors 530, 532, and 534 correspond to sensors 230 as shown in FIG. 19 , but are individually identified to disclose their placement or location within measurement device 154 relative to superior location 580, inferior location 582, anterior location 586, and posterior location 584 in the shoulder joint. Sensors 530, 532, and 534 are labeled S3, S6, and S8, respectively, on measurement device 154. Measurement device 154 also includes reference sensor 536, labeled S5. As previously described, sensors 530, 532, and 534 are equally spaced from one another and positioned as close as possible to rim 242 to maximize the measurement area. As shown, sensor 530 is located near superior location 580. Sensor 532 is located between posterior location 584 and inferior location 582. Sensor 534 is located between anterior location 586 and inferior location 582. Therefore, the measurement data from each sensor can be correlated with movement to better understand how shoulder position affects load. Measurement data from sensors 530, 532, 534 and reference sensor 536 is transmitted wirelessly to computer 162. The measurement data from sensors 530, 532, and 534 is used by computer 162 to calculate the magnitude and contact points of the load on the outer curved surface 224 of measurement device 154, FIG. 21 .A display 164 coupled to the computer 162 can display the load magnitude and contact points for viewing by the surgeon and surgical team.

[0089] In this example, a shoulder implant is placed in the patient's shoulder. The measurement device 154 is placed in the shoulder joint and powered on. The shoulder is moved through a predetermined range of motion. Measurement data from the measurement device 154 is captured by the computer 162. In one embodiment, the shoulder can be impinged from a neutral position. The display 164 provides a graph 572 showing load data from sensors 530, 532, 534, reference sensor 536, and the combined load data from sensors 530, 532, and 534 as the shoulder joint is moved through different predetermined motions. Graph 572 illustrates what a surgeon or surgical team would see if the measurement data from each sensor were presented graphically. Sensors 530, 562, 564, and 568 are represented on graph 572 by different colors, grayscale shades, or patterned lines, as indicated by legend 574. In legend 574, sensor key 560 shows measurement data associated with sensor 530 (S3) on graph 572. The sensor key 562 shows measurement data on the graph 572 associated with the reference sensor 536 (S5) adjacent the upper position 580 of the metering device 154. The sensor key 564 shows measurement data on the graph 572 associated with the sensor 532 (S6) between the rearward position 584 and the lower position 582 of the metering device 154. The sensor key 568 shows measurement data on the graph 572 associated with the sensor 534 (S8) between the forward position 586 and the lower position 582 of the metering device 154. Finally, the total key 570 shows measurement data on the graph 572 associated with the sum of the load measurement data associated with the sensors 530 (S3), 532 (S6), and 534 (S8).

[0090] Box 540 of graph 572 corresponds to neutral shoulder rotation during adduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) shows that sensor 534 experiences a heavier load during neutral shoulder rotation during adduction than sensors 530 (S3) and 532 (S6). In this example, reference sensor 536 (S5) is not loaded. The load on sensor 534 (S8) varies between 5 lb and 17 lb during neutral shoulder rotation during adduction. Due to the small load contributions of sensors 530 (S3) and 532 (S6), total 570 appears similar to sensor 534 (S8) during neutral shoulder rotation during adduction. In general, the surgeon can graphically see where the load occurs relative to the movement and what each sensor is measuring during neutral shoulder rotation during adduction.

[0091] Box 542 in graph 572 corresponds to external rotation of the shoulder during adduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) shows that sensor 530 (S3) and sensor 534 (S8) have lower loads than sensor 532 (S6) during external rotation of the shoulder during adduction. In this example, reference sensor 536 (S5) is not loaded. The load on sensor 532 (S6) varies between 7 lb and 15 lb during external rotation of the shoulder during adduction. Due to the small load contributions of sensors 530 (S3) and 535 (S8), total 570 appears similar to sensor 532 (S6) during external rotation of the shoulder during adduction. Generally, the surgeon can graphically see where the load occurs relative to the movement and what each sensor is measuring during external rotation of the shoulder during adduction.

[0092] Box 544 of graph 572 corresponds to internal rotation of the shoulder during adduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) show that during internal rotation of the shoulder during adduction, sensors 530 (S3), 532 (S6), and 534 (S8) have significant loads of greater than 10 lb. Reference sensor 536 (S5) is noisy during this measurement and has loads as high as 5 lb. As previously mentioned, these measurement graphs are exemplary only. During the early portion of internal rotation of the shoulder during adduction, sensor 534 (S8) has a reading of greater than 40 lb, after which this reading significantly decreases to below 20 lb. Conversely, during the early portion of internal rotation of the shoulder during adduction, sensors 530 (S3) and 532 (S6) have no load readings and then have load readings of greater than 10 lb. The load on sensor 532 (S6) varies between 7 lb and 15 lb during external rotation of the shoulder in adduction. The total 570 is the combined load on sensors 530 (S3), 532 (S6), and 534 (S8) during internal rotation of the shoulder in adduction of over 50 lb during the rotation portion. Generally, the surgeon can see graphically where the load occurs relative to the motion and what each sensor is measuring during internal rotation of the shoulder in adduction.

[0093] Box 546 of graph 572 corresponds to neutral shoulder rotation during abduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) show that sensors 530 (S3) and 534 (S8) are loaded less than sensor 532 (S6) during neutral shoulder rotation during abduction. Reference sensor 536 (S5) is unloaded. The load on sensor 532 (S6) varies from 12 lb to over 40 lb during neutral shoulder rotation during abduction. While sum 570 appears similar to sensor 532 (S6) during neutral shoulder rotation during abduction, the load components of sensors 530 (S3) and 534 (S8) contribute such that sum 570 does not overlap sensor key 564 during neutral shoulder rotation during abduction. In general, the surgeon can see graphically where the loads for the motion occur and what each sensor is measuring during neutral shoulder rotation during abduction.

[0094] Box 548 of graph 572 corresponds to external rotation of the shoulder during abduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) show that sensors 530 (S3) and 534 (S8) are loaded less than sensor 532 (S6) during external rotation of the shoulder during abduction. Reference sensor 524 (S5) is unloaded. The load on sensor 532 (S6) varies between 13 lb and 16 lb during external rotation of the shoulder during abduction. Because the loads from sensors 530 (S3) and 534 (S8) are added, total 570 appears similar to, but different from, the load data from sensor 532 (S6) during external rotation of the shoulder during abduction. In general, the surgeon can graphically see where the load occurs relative to the motion and what each sensor is measuring during external rotation of the shoulder during abduction.

[0095] Box 550 of graph 572 corresponds to internal rotation of the shoulder during abduction. Measurement data from sensors 530 (S3), 532 (S6), and 534 (S8) show that sensors 530 (S3) and 534 (S8) are loaded less than sensor 532 (S6) during internal rotation of the shoulder during abduction. Reference sensor 524 (S5) is unloaded. The load coupled to sensor 532 (S6) varies between 15 lb and 19 lb during internal rotation of the shoulder during abduction. Because the loads from sensors 530 (S3) and 534 (S8) are added, total 570 appears similar to, but different from, the load data from sensor 532 (S6) during external rotation of the shoulder during abduction. In general, the surgeon can graphically see where the load occurs relative to the motion and what each sensor is measuring during internal rotation of the shoulder during abduction.

[0096] FIG. 28 shows a cross-sectional view of the outer curved surface 224 of the measurement device 154 as shown in FIG. 21 in accordance with an exemplary embodiment. In this example, three sensors are used to measure the load and the location of the load as the glenosphere contacts and loads the outer curved surface 224. The three sensors are equidistant from each other. Sensors 530 and 532 are shown in the cross-sectional view. The center 589 of the glenosphere is shown with the axis 588 of the glenosphere shown in dashed line. Sensor 530 is at an angle φ from the axis 588 of the glenosphere. Similarly, sensor 532 is at an angle φ from the axis 588 of the glenosphere. In one embodiment, impingement is detected when the measured force angle α exceeds this angle φ. Alternatively, impingement may be detected if the measured force angle α does not correlate to the assumptions that the applied force is perpendicular to the exterior curved surface 224, that the reaction force is sensed relative to the center of rotation, that there are no moment arms, and that a simple force balance applies. In one embodiment, a position measurement system or IMU can be used to measure the first angle α. The second angle α can be measured using measurement data from three sensors. The first and second angles α can be compared to each other as a redundancy check or to determine if the measurement is outside of angle φ to determine impingement.

[0097] FIG. 29A is an illustration of a spherical coordinate system 600 for calculating force and position, according to an exemplary embodiment. In one embodiment, the spherical coordinate system 600 is realistic and can be used to mathematically describe the outer curved surface 224 of the measurement device 154, as shown in FIG. 21 . The outer curved surface 224 of the measurement device 154 is configured to couple to a prosthetic component of a joint and support motion of the joint. In this example, the origin 602 of the spherical coordinate system 600 is the center of curvature of the outer curved surface 224. The positive Z axis extends from the origin 602 to the outer curved surface 224 and intersects a plane equidistant from each sensor coupled to the outer curved surface 224. Points in the spherical coordinate system 600 can be defined by a radius r, an angle θ, and an angle φ, as shown in FIG. 29A . In this example, the radius r is the radius of curvature of the curved surface 224. Theta (θ) is the angle measured from the radius r to the Z axis. Phi (φ) is the angle measured from the X axis and dashed line 604. Dashed line 604 can be calculated by equation 1 on Figure 29A, r x sin(φ). Dashed line 604 lies in the XY plane. Note that a convex external curved surface (the ball of the joint instead of a cup) can be modeled similarly.

[0098] FIG. 29B is an example of force and position calculations related to sensor location, according to an illustrative embodiment. Referring briefly to FIG. 27B, sensors 530, 532, and 534 are configured to measure force, pressure, or load applied to the exterior curved surface 224 of the metering device 154. As previously described, the sensor locations and force and position calculations can correspond to either a ball-shaped prosthetic component or a cup-shaped prosthetic component. Generally, sensors 530, 532, and 534 are positioned equidistant from one another, with the largest radius of a circle on the exterior curved surface 224 defined by sensors 530, 532, and 534. Referring briefly to FIGS. 27B and 29B, sensor 530 is located near an upper position 580 and is referred to herein as the upper sensor of the metering device 154. Sensor 532 is between a rearward position 584 and a lower position 582 and is referred to herein as the lower-left sensor. Sensor 534 is located between forward position 586 and lower position 582 and is referred to herein as the lower right sensor. In this example, radius r is given a value of 0.748 inches for prototype measurement device 154. Sensors 530, 532, and 534 are located as close as possible to the XY plane on outer curved surface 224 to maximize the measurement area on curved surface 224.

[0099] In this example, the radial positions of sensors 530, 532, and 534 are described in Equation 2 of Figure 29B. sis the angle measured from the Z axis as if each sensor 530, 532, and 534 were located on the dashed circle 606. The angular positions of sensors 530, 532, and 534 are defined by equation 3 in FIG. 29B. The angular positions are relative to the X axis. Sensor 530 is located at φ1 = π / 2 on the dashed circle 606. Sensor 534 is located at φ2 = 11π / 6 on the dashed circle 606. Sensor 532 is located at φ3 = 7π / 6 on the dashed circle 606. In one embodiment, the sensor unit vector represents the direction from the sensor to the origin 602. The sensor unit vector is the assumed direction of the sensor's reaction force. The equation for the unit vector associated with sensors 530, 532, and 534 is

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[0100] FIG. 30 is a diagram illustrating calculation of force magnitude from measurement data from sensors 530, 532, and 534, according to an exemplary embodiment. Force magnitude calculations can be used with the measurement device as a ball or as a cup. Thus, measurement device 154 can be mounted on a reverse shoulder, a conventional shoulder, the femoral head of a femoral prosthetic component of a hip joint, or the acetabular cup of a hip joint. The calculation of the force magnitude and location of the applied force assumes that the outer curved surface 224 of measurement device 154 is frictionless, as shown in FIG. 21 . As shown in FIG. 27B , the interface between outer curved surface 224 and sensors 530, 532, and 534 is fully constrained. In one embodiment, only sensors 530, 532, and 534 are used for full constraint when sensors 530, 532, and 534 are directed at the center of curvature of outer curved surface 224 so that all force vectors pass through the same point without moments for equilibrium. The reaction force vectors are assumed to be orthogonal to exterior curved surface 224 and therefore pass through the same point in space at the origin 602, which is the center of curvature. Generally, sensors 530, 534, and 532 measure the loads applied to exterior curved surface 224, where the scalar reaction forces are represented by S1, S2, and S3, respectively, for the sensors listed above. Reaction Force Vector

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[0040] Therefore, the magnitude of the load at contact 610 can be calculated in real time from the measurement data from sensors 530, 532, and 534.

[0101] 31 is a diagram showing the calculation of the position of an applied load on the exterior curved surface 224 of the measurement device 154 using measurement data from sensors 530, 532, and 534, according to an exemplary embodiment. Referring briefly to FIG. 22A, a contact point 382 is shown on surface 384 of GUI 380 and on display 164. Note that surface 384 is a two-dimensional image of a three-dimensional surface. The exact placement of the contact point on the two-dimensional image of the three-dimensional surface is disclosed herein below for GUI 380. In this example, R 3 The point of application of the load at is projected onto the XY plane and the position of the load is displayed. In this example, point 612(x a ,y a ) is the position of the load projected onto the XY plane. In one embodiment, the applied force vector

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[0102] In one embodiment, measurement data from force sensors 530, 532, and 534 is used to detect impingement, as shown in FIG. 22B. For example, impingement causes repetitive load spikes around the periphery. The measurement data captures load spikes of 10 to 30 lb that occur near the impingement point and is used to detect impingement. The force magnitude and contact point where the prosthetic component couples with the outer curved surface 224 of the measurement device 154 are calculated from the measurement data from sensors 530, 532, and 534, as disclosed hereinabove. A position measurement system can also provide measurement data to support the measurement of the force magnitude and contact point. In this example, certain assumptions are made in the calculation. Sensors 530, 532, and 534 are positioned equidistant from each other at locations that maximize the radius of the circle defined by these sensors. Sensors 530, 532, and 534 are oriented such that the reaction forces of these sensors are directed toward the center of curvature of the outer curved surface 224. In one embodiment, it is assumed that there are no or negligible friction forces occurring at the exterior curved surface 224 or at the sensor interface. In one embodiment, the reaction force vector is assumed to be orthogonal to the exterior curved surface 224 and therefore pass through the center of curvature of the exterior curved surface 224. When calculating load magnitudes and contact points using the forces applied to sensors 530, 532, and 534, specific force combinations may only exist that are possible when utilizing one or more of the assumptions disclosed herein above. In one embodiment, a force combination that falls outside of one or more assumptions may mean that one or more forces measured by sensors 530, 532, and 534 are not orthogonal to the exterior curved surface 224 of the measurement device 154. Alternatively, the force vector may not pass through the center of curvature of the exterior curved surface 224. Any force combination measured by sensors 530, 532, and 534, other than the possible combinations determined by one or more of the assumptions disclosed herein, should be viewed or considered as impingement. Additionally, time-based analysis of load data from sensors 530, 532, and 534 can be used and correlated against known impingement to detect impingement.As previously mentioned, sudden changes in the measured load vector also correspond to impingement. In one embodiment, a position measurement system, such as an IMU (Inertial Measurement Unit), can be used to monitor movement and correlate against known joint motion for specific movements to detect anomalies indicative of impingement. Joint geometry may also be susceptible to impingement in specific directions. If so, predetermined movements can be performed on the joint to determine if impingement occurs, and adjustments can be made based on quantitative measurement data.

[0103] FIG. 32 is a block diagram of the electronics 236 within the measurement device 154, according to an exemplary embodiment. Generally, the electronics 236 couples to one or more sensors to measure one or more parameters. Components in FIGS. 3, 5-21 are referenced herein in the following discussion and may relate operation of the measurement device 154 to the electronics 236. The sensors may measure parameters such as height, length, width, tilt / gradient, position, orientation, load magnitude, force, pressure, contact position, displacement, density, viscosity, pH, light, color, sound, optics, blood volume, visual perception, humidity, alignment, positioning, rotation, inertial sensing, turbidity, bone density, fluid viscosity, strain, angular deformation, vibration, torque, elasticity, movement, acceleration, infection, pain, and temperature, to name just a few. In this example, the electronics 236 is configured to control the measurement process, receive measurement data from the sensors 230, receive measurement data from the position measurement system 742, and transmit the measurement data to the computer 162 for further analysis and feedback. More specifically, sensors 230 measure force, pressure, or load at predetermined locations on exterior curved surface 224. Sensors 230 at predetermined locations include sensors 530, 532, and 534, as shown in FIG. 27B. Position measurement system 742 measures position, movement, rotation, velocity, acceleration, or distance. In one embodiment, position measurement system includes an inertial measurement unit (IMU) 744 configured to measure nine degrees of freedom. IMU 744 can include one or more inertial sensors. In one embodiment, sensors 230 and position measurement system 742 are housed within measurement device 154.

[0104] The electronic circuitry 236 includes a power management circuit 700, a control logic 702, a memory 704, an interface circuit 706, a position measurement system 742, and a wireless communication circuit 720. A power source 740 couples to the electronic circuitry 236 to provide power for the measurement process. The power source 740 can be an inductor, a supercapacitor, a rechargeable battery, a wired power source, a wireless power source, a solar cell, an energy harvesting element, or other power storage media. In one embodiment, the power source 740 includes a battery 312. The electronic circuitry 236 further includes a transceiver, which can be positioned on, engaged with, attached to, or affixed to a wide range of physical systems configured to transmit and communicate parameters of interest in real time, including, but not limited to, instruments, equipment, devices, prosthetic components, or other physical systems for use on or within the human body. The electronic circuits 236 are coupled together to form an electronic system using multiple layers of interconnections on the printed circuit board 234. A flexible interconnect 228 can be used to couple the electronic circuitry 236 to a remotely located sensor 230 .

[0105] The electronic circuitry 236 can be configured to provide bidirectional communication between the measurement device 154 and the computer 162. In one embodiment, the measurement device 154 provides quantitative measurement data related to the placement of the shoulder joint. The measurement device 154 is configured to provide quantitative measurement data related to the magnitude of the load, the location of the applied load, position, and rotation. In a kinematic assessment, the computer 162 uses the measurement data from the measurement device 154 to support the placement of prosthetic components to ensure optimal load, balance, stability, alignment, range of motion, reduce impingement, and improve performance and reliability based on clinical evidence.

[0106] The power source 740 provides power to the electronic circuitry 236 and the sensor 230. The power source 740 can be temporary or permanent. In one embodiment, the power source is not rechargeable. The measuring device 154 is disposable after a single use, and the power in the battery 312 is insufficient for a second procedure. The measuring device 154 is destroyed or discarded after use. Alternatively, the power source 740 can be rechargeable. The measuring device 154 is sterilized before being reused. Charging the power source 740 can include wired energy transfer or short-range wireless energy transfer. Charging sources for charging the power source 740 can include, but are not limited to, one or more batteries, an AC power source, a radio frequency receiver, an electromagnetic induction coil, one or more photoconductive cells, one or more thermocouples, or transducer energy transfer. In one embodiment, if the power source 740 does not have enough energy to complete the procedure, energy transfer to the power source 740 enables a single-use scenario. Additionally, the metering device 154 can utilize the power management circuitry 700 to minimize power consumption of the power supply 740 when in use or when the electronic circuitry 236 is idle.

[0107] As previously mentioned, the power source 740 in the measurement device 154 includes the battery 312. The battery 312 can be charged by the methods disclosed hereinabove. Alternatively, the power source 740 can be a supercapacitor, inductor, or other power storage device. An external charging source can be wirelessly coupled to a rechargeable battery, capacitor, or inductive power storage device via an electromagnetic induction coil via inductive charging. Charging operations can be controlled by a power management circuit 700 in the electronic circuit 236. In one embodiment, the power management circuit 700 supports operation of the measurement device 154 during charging if a low charge in the power source 740 is detected, thereby allowing surgery to continue. For example, power can be transferred to the battery 312, capacitive power storage device, or inductive power storage device using efficient step-up and step-down voltage conversion circuits. This conserves operating power for circuit blocks at minimum voltage levels to support the required level of performance.

[0108] The power management circuit 700 is configured to operate under strict power constraints. In one embodiment, the power management circuit 700 controls power-up and power-down to minimize power usage during operation. The power management circuit 700 is configured to reduce power dissipation during system operation. The power management circuit 700 can turn off or reduce power supplied to circuits not being used in a particular operation. Similarly, when the system is idle and not being used, the power management circuit 700 can place other unused circuits in a sleep mode that wakes them up before the next measurement is taken. The power management circuit 700 can include one or more voltage regulation circuits that provide multiple different stable voltages to the electronic circuit 236 and the sensor 230.

[0109] In one configuration, the charging operation of the power source 740 can further serve to communicate downlink data to the electronic circuitry. For example, downlink control data can be modulated onto an energy source signal and then demodulated from an inductor within the electronic circuitry 230. This can serve as a more efficient way to receive downlink data instead of configuring an internal transceiver within the electronic circuitry 230 for both uplink and downlink operation. As an example, the downlink data can include updated control parameters used by the measurement device 154 when taking measurements such as external position information or for recalibration purposes. It can also be used to download serial numbers or other identification data.

[0110] The control logic 702 controls the measurement process or sequence that activates sensors, converts measurement data into a usable format, and transmits the information. The control logic 702 can include digital circuits, microcontrollers, microprocessors, ASICs (application-specific integrated circuits), DSPs (digital signal processing), gate array implementations, standard cell implementations, and other circuits. The control logic 702 couples to memory 704. The memory 704 is configured to store measurement data, software routines, diagnostic / test routines, calibration data, calibration algorithms, workflows, and other information or programs. In one embodiment, one or more sensors can be continuously enabled to the control logic 702 and periodically sampled. The control logic 702 controls the measurement process, stores measurement data in memory, or transmits measurement data in real time. The control logic 702 includes dedicated ports that can couple to sensors to receive measurement data continuously or receive updated measurements at a high sampling rate. Alternatively, the control logic 702 can select the sensor to measure. For example, multiple sensors can be coupled to the control logic 702 via a multiplexer. The control logic 702 controls which sensors are coupled via the multiplexer to sample and output measurement data. Multiplexed measurement data is useful when the measurement data is not critical or can be sampled occasionally as needed. The control logic 702 can also select and receive measurement data from different sensors in sequence or simultaneously via parallel channels. The control logic 702 can be configured to monitor the measurement data from the sensors but transmit the measurement data only if a change occurs in the measurement data. Furthermore, the control logic 702 can correct the measurement data before transmitting it to the computer 162. For example, the measurement data can be corrected for nonlinearity using calibration data.In one embodiment, a microcontroller with Bluetooth Low Energy (BLE) is used along with an analog-to-digital converter to convert the analog values ​​to digital.

[0111] The interface circuit 706 couples between the sensors 230 and the control logic 702. The interface circuit 706 supports conversion of sensor output into a format that can be received by the computer 162. The interface circuit 706 includes digital and analog circuits. The analog circuits can include multiplexers, amplifiers, buffers, comparators, filters, passive components, analog-to-digital converters, and digital-to-analog converters, to name just a few. In one embodiment, the interface circuit 706 uses one or more multiplexers to select sensors for providing measurement data to the control logic 702. The control logic 702 is configured to provide control signals that enable the multiplexers to select the sensors for measurement. The multiplexers can deliver or transmit the measurement data to the control logic 702, memory 704, or both. Typically, at least one analog-to-digital or digital-to-analog conversion of the measurement data occurs via the interface circuit 706.

[0112] The sensor 230 couples to the control logic 702 via an interface circuit 706. Alternatively, the interface circuit 706 can be directly coupled to the circuitry for transmitting measurement data as it is measured. While the one or more physical parameters of interest measured by the sensor 230 are force, pressure, or load as disclosed herein, the sensor 230 can further include other sensors measuring height, length, width, tilt / gradient, position, orientation, load magnitude, force, pressure, contact position, displacement, density, viscosity, pH, light, color, sound, optics, vascular flow, visual perception, humidity, alignment, rotation, inertial sensing, turbidity, bone density, fluid viscosity, strain, angular deformation, vibration, torque, elasticity, motion, and temperature. Often, a measured parameter is used in combination with other measured parameters to perform kinematic and qualitative assessments. In joint reconstruction, portions of the musculoskeletal system are prepared to receive prosthetic components. This preparation can include bone cutting or formation to mate with one or more prosthetic devices. Parameters can be assessed relative to orientation, stability, alignment, impingement, direction, displacement, or position, as well as movement, rotation, or acceleration along one axis or a combination of axes, by wireless sensing modules or devices positioned on or within a body, equipment, instrument, medium, gear, or other physical system.

[0113] The sensor 230 can measure the parameter of interest directly or indirectly. For example, the load sensor in the measurement device 154 can include a capacitor, piezoelectric sensor, or MEMS sensor, which can compress when a load is applied to the load sensor. Measuring load using a capacitor is an indirect form of sensing because the capacitance value of the capacitor changes with the amount of load applied to the capacitor. The capacitance measurement data can be sent to the computer 162 for further processing. The computer 162 can include software and calibration data related to the elastic capacitor. The load measurement data can be converted from a capacitance value to a load measurement value. The computer 162 can store calibration data and use this calibration data to curve fit and compensate for the nonlinear output of the sensor over its operating range. Additionally, the computer 162 can combine individual sensor measurements to generate other measurement data. In keeping with this example of load measurement data, the individual load measurement data can be combined or evaluated to determine the location where the load is applied to the surface to which the load sensor is coupled. The measurement data can be displayed on a display, which helps the surgeon quickly adapt the measurement data. For example, calculated metrology data regarding the location of a load applied to a surface may have little or no meaning to the surgeon. Conversely, an image of the surface being loaded with respect to the contact points displayed on the surface allows the surgeon to quickly adapt and determine if there is a problem with the contact points.

[0114] In one embodiment, the shoulder joint system 160 transmits and receives information wirelessly. Wireless operation reduces clutter in the surgical field, wired distortion of measurements, or limitations on measurements caused by potential physical interference or limitations imposed by cables connecting data collection, storage, or display equipment within the operating room environment to internally powered devices. The electronic circuitry 236 includes a wireless communication circuit 720. In one embodiment, the wireless communication circuit 720 is configured for short-range telemetry and battery operation. Typically, the measurement device 154 and computer 162 are located within the operating room so that transmission of measurement data from the measurement device 156 to the computer 162 is less than 10 meters. As shown, an exemplary communication system includes the wireless communication circuit 720 of the measurement device 154 and a receiving system of the wireless communication circuit 722 of the computer 162. The wireless communication circuit 720 includes, but is not limited to, the antenna 360, the matching network 716, the telemetry transceiver 714, the CRC circuit 712, the data packetizer 710, and the data input 708. The wireless communication circuit 720 may include more or fewer components than those shown and is not limited to these shown components or the order of the components.

[0115] Similarly, the computer 162 includes a wireless communication circuit 722. The wireless communication circuit 722 includes an antenna 724, a matching network 726, a telemetry receiver 728, a CRC circuit 730, and a data packetizer 732. Notably, other interface systems can be directly coupled to the data packetizer 732 to process and render the sensor data. Generally, the electronic circuit 236 is configured to couple to the sensors 230 and transmit quantitative measurement data in real time to the computer 162 for processing, display, analysis, and feedback. The measurement device 154 includes multiple load sensors configured to measure loads applied to the external curved surface 224. The measurement device 154 further includes an inertial measurement unit having one or more inertial sensors and other parameter measurement sensors listed herein above. The measurement data from the multiple load sensors and inertial sensors is transmitted to the computer 162. The computer 162 can calculate the magnitude of the load applied to the external curved surface 224 from the multiple load sensors. In this example, three load sensors are used for measurement. The computer 162 can further calculate the position (contact point) of the load applied to the exterior curved surface 224 of the measuring device 154. The measuring device 154 can further use measurement data from the position measurement system 742 to monitor the position and movement of the measuring device 154 or prosthetic components. The position or tracking data from the position measurement system 742 is also transmitted to the computer 162. These results can also be displayed on the display 164 of the computer 162. In one embodiment, the measurement data from the position measurement system 742 can be used to measure range of motion, alignment, and impingement. In one embodiment, measurement data transmitted from different sensors or components can be transmitted on different channels, or the measurement data can be transmitted on the same channel at different times.

[0116] As previously described, the wireless communication circuitry includes a data input 708, a data packetizer 710, a CRC circuit 712, a telemetry transmitter 714, a matching network 716, and an antenna 718. Generally, measurement data from the sensor 230 is provided to the data input 708 of the wireless communication circuitry 720. In one embodiment, the measurement data from the sensor 230 can come directly from the interface circuit 706, from the memory 704, from the control logic 702, or from a combination of paths to the data input 708. In one embodiment, the measurement data can be stored in the memory 704 before being provided to the data input 708. The data packetizer 710 assembles the measurement data into packets, including the sensor information received or processed by the control logic 702. The control logic 702 can include specific modules to efficiently perform the core signal processing functions of the measurement device 154. The control logic 702 provides the additional benefit of a reduced form factor that meets size requirements for integration into the measurement device 154.

[0117] Typically, the measurement data from the measurement device 154 is encrypted. In one embodiment, the output of the data packetizer 710 is coupled to the input of a CRC circuit 712. The CRC circuit 712 applies error code detection to the packet data. A cyclic redundancy check is based on an algorithm that calculates a checksum for a data stream or packet of any length. These checksums can be used to detect interference or accidental modification of data during transmission. The cyclic redundancy check is particularly good at detecting errors caused by electrical noise, allowing robust protection against improper processing of corrupted data in environments with high levels of electromagnetic activity. The output of the CRC circuit 712 is coupled to the input of a telemetry transceiver 714. The telemetry transceiver 714 then transmits the CRC-encoded data packet via the antenna 360 and through a matching network 716. The telemetry transceiver 714 can increase the carrier frequency by one or more steps and add information or measurement data from the measurement device 154 to the carrier frequency. The matching network 716 provides impedance matching to achieve optimal communication power efficiency between the telemetry transmitter 714 and the antenna 360 .

[0118] The antenna 360 can be integrated with components of the measurement device 154 to provide radio frequency transmission. The substrate for the antenna 360 and its electrical connection to the electronic circuitry 236 can further include a matching network 716. In one embodiment, the antenna 360 and a portion of the matching network 716 can be wires interconnecting the components comprising the electronic circuitry 236, or can be formed on the printed circuit board 234 interconnecting the components comprising the electronic circuitry 236. This level of integration of the antenna and electronics allows for reductions in the size and cost of the wireless device. Potential applications can include, but are not limited to, components for any type of musculoskeletal equipment or prosthesis that can use a compact antenna. This includes disposable, reusable, and long-term use modules or devices.

[0119] The receiving process of the wireless communication circuit 722 is the reverse of the transmitting process. The antenna 724 receives the measurement data transmitted from the wireless communication circuit 720. The wireless communication circuit 720 can transmit at low power so that the receiving wireless communication circuit 722 must be in close proximity, such as within 10 meters, to receive the measurement data. The antenna 724 is coupled to a matching network 726, which efficiently couples the measurement data to a telemetry transmitter circuit 728. The measurement data can be transmitted on a carrier signal that supports wireless transmission. The measurement data is stripped from the carrier signal by the telemetry transmitter 728. The measurement data is received from the telemetry transmitter 728 by a CRC circuit 730. The CRC circuit 730 performs a cyclic redundancy check algorithm to verify that the measurement data was not corrupted during transmission. The CRC circuit 730 provides the checked measurement data to a data packetizer 732. The data packetizer 732 reassembles the measurement data and provides it to a USB interface 734. The USB interface 734 provides the measurement data to the computer 162 for further processing.

[0120] It should be noted that the measurement, transmission, reception, and processing of measurement data can be performed in real time for use in assisting the surgeon in installing the shoulder joint. In one embodiment, the computer 162 displays at least a portion of one prosthetic component. In this example, the outer curved surface 224 and rim 242 of the measurement device 154 are displayed on a display 164 coupled to the computer 162. Measurement data from the sensors 230 and the position measurement system 742 are used to calculate the magnitude of the load on the outer curved surface 224 of the measurement device 154 and the location of the applied load. The position of each load sensor relative to the outer curved surface 224 is known. The location of the applied load can be calculated using the position information from each load sensor and the magnitude of the load at each location by the computer 162, as disclosed in detail hereinabove. The location of the applied load is also referred to as a contact point 382 on the GUI 380 of the display 164. Similarly, the magnitude of the load at the contact point 382 can be calculated from the three load sensors and their locations. Generally, the shoulder joint is moved through a predetermined range of motion. The minimum load, maximum load, and load at the current position are displayed on the GUI 380 in display boxes 380, 390, and 386, respectively. The amount of rotation or range of motion can also be indicated. These measurements are measured or calculated in real time. The rim 242 can also be highlighted to indicate impingement during a given range of motion. In one embodiment, the rim 242 highlights an area of ​​the rim 242 proximate to the measured impingement. Adjustments affecting alignment, load, load position, rotation, or other parameters can be made and monitored in real time on the display 164. These adjustments support optimization after measured parameters are within specifications, allowing the quantitative measurement data to be used to fine-tune the placement of prosthetic components.

[0121] 33 is a block diagram of a system or computer according to an exemplary embodiment. An exemplary graphical representation of a machine, system, or computer in the form of system 800 includes a set of instructions, when executed within the system, that can cause the machine to perform any one or more of the methodologies discussed above. In some embodiments, the machine operates as a standalone device. In some embodiments, the machine can be connected to other machines (e.g., using a network). In a networked deployment, the machine can operate in the capacity of a server or client user machine in a server-client user network environment, or as a peer machine in a peer-to-peer (or distributed) network environment.

[0122] A machine may include a server computer, a client user computer, a personal computer (PC), a tablet PC, a laptop computer, a desktop computer, a control system, a logic circuit, a sensor system, an ASIC, an integrated circuit, a network router, a switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by the machine. It will be understood that a device of the present disclosure broadly includes any electronic device that provides voice, video, or data communications. Furthermore, although a single machine is shown, the term "machine" shall also be interpreted to include any collection of machines that individually or jointly execute a set (or sets) of instructions to perform any one or more of the methodologies discussed herein.

[0123] System 800 may include a processor 802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both), a main memory 804, and a static memory 806, which communicate with each other via a bus 808. System 800 may further include a video display 810 (e.g., a liquid crystal display (LCD), a flat panel, a solid-state display, or a cathode ray tube (CRT)). System 800 may include input devices 812 (e.g., a keyboard), a cursor control device 814 (e.g., a mouse), a disk drive unit 816, a signal generation device 818 (e.g., a speaker or remote control), and a network interface device 820.

[0124] Disk drive unit 816, which may be another type of memory, such as flash memory, may include machine-readable medium 822 on which one or more sets of instructions 824 (e.g., software) are stored that embody any one or more of the methodologies or functions described herein, including those methods set forth above. Also, instructions 824 may reside completely or at least partially within main memory 804, static memory 806, and / or processor 802 during their execution by system 800. Also, main memory 804 and processor 802 may be considered machine-readable media.

[0125] Specialized hardware implementations, including, but not limited to, application specific integrated circuits, programmable logic arrays, and other hardware devices, can similarly be constructed to implement the methods described herein. Applications that can include the apparatus and systems of various embodiments broadly include a variety of electronic and computer systems. Some embodiments implement functionality within two or more specific interconnected hardware modules or devices, using associated control and data signals communicated between and through the modules, or as part of an application specific integrated circuit. Thus, the system examples are applicable to software, firmware, and hardware implementations.

[0126] According to various embodiments of the present disclosure, the methods described herein are for operation as a software program executing on a computer processor. Furthermore, software implementations may include, but are not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing, which may also be constructed to implement the methods described herein.

[0127] The present disclosure contemplates machine-readable media containing instructions 824, or receiving and executing instructions 824 from a propagated signal, such that devices connected to network environment 820 can transmit or receive audio, video, or data and communicate over network 826 using instructions 824. Additionally, instructions 824 can be transmitted or received over network 826 via network interface device 820.

[0128] While the exemplary embodiment shows machine-readable medium 822 to be a single medium, the term "machine-readable medium" should be interpreted to include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) that store one or more sets of instructions. The term "machine-readable medium" should also be interpreted to include any medium that can store, encode, or carry a set of instructions for execution by a machine, causing the machine to perform any one or more of the methodologies of the present disclosure.

[0129] Accordingly, the term "machine-readable medium" shall be interpreted to include, but not be limited to, solid-state memory, such as a memory card or other package containing one or more read-only (non-volatile) memories, random-access memories, or other re-writable (volatile) memories; magneto-optical or optical media, such as disks or tapes; and carrier wave signals, such as signals embodying computer instructions in transmission media, and / or digital file attachments to email or other self-contained information archives or archive sets, are considered distribution media equivalent to tangible storage media. Accordingly, the present disclosure shall be deemed to include any one or more of the machine-readable media or distribution media enumerated herein, including art-recognized equivalents and successor media on which the software implementations herein may be stored.

[0130] Although this specification describes components and functions implemented in embodiments with reference to particular standards and protocols, the present disclosure is not limited to such standards and protocols. Standards for the Internet and other packet-switched network transmissions (e.g., TCP / IP, UDP / IP, HTML, HTTP) represent examples of the current state of the art. Such standards are periodically superseded by faster or more efficient equivalents having essentially the same functionality. Accordingly, replacement standards and protocols having the same functionality are considered equivalents.

[0131] 34 is an illustration of a communications network 900 for metering and reporting, according to an exemplary embodiment. Simply put, the communications network 900 extends pervasive data connectivity to other devices or services. As shown, a metering and reporting system 902 can be communicatively coupled to the communications network 900 and any associated systems or services.

[0132] As an example, the measurement system 902 can share its parameters of interest (e.g., angles, loads, balance, distances, alignment, displacements, motions, rotations, and accelerations) with a remote service or provider, such as for analysis or reporting on the status or outcomes of a procedure. This data can be shared, for example, with a service provider to monitor progress or with a plan administrator for surgical monitoring purposes or effectiveness studies. Additionally, the communications network 900 can be associated with an electronic medical record (EMR) system to implement healthcare information technology practices. In other embodiments, the communications network 900 can be communicatively coupled to a hospital information system (HIS), hospital information technology (HIT) and hospital information management (HIM), electronic health records (EHR), computerized physician order entry (CPOE), and computerized decision support systems (CDSS). This provides the functionality for various information technology systems and software applications to communicate and exchange data accurately, efficiently, and consistently, and to use the exchanged data.

[0133] The communications network 900 may provide wired or wireless connectivity via a local area network (LAN) 904, a wireless local area network (WLAN) 910, a cellular network 906, and / or other radio frequency (RF) systems (see FIG. 4). The LAN 904 and WLAN 910 may be communicatively coupled to the Internet 908, such as through a central office. The central office may house a common network switch for delivering telecommunications services. The telecommunications services may include traditional POTS (plain old telephone service) and broadband services such as cable, HDTV, DSL, VoIP (voice over internet protocol), IPTV (internet protocol television), and internet services.

[0134] Communications network 900 may support circuit-switched and / or packet-switched communications using common computing and communications technologies. Standards for the Internet 908 and other packet-switched network transmissions (TCP / IP, UDP / IP, HTML, HTTP, RTP, MMS, SMS) represent examples of the current state of the art. Such standards are periodically superseded by faster or more efficient equivalents having essentially the same functionality. Accordingly, replacement standards and protocols having the same functionality are considered equivalents.

[0135] The cellular network 906 can support voice and data services via many access technologies, such as GSM-GPRS, EDGE, CDMA, UMTS, WiMAX, 2G, 3G, WAP, software defined radio (SDR), and other known technologies. The cellular network 906 can be coupled to a reference station receiver 912 under a frequency reuse plan for communicating with mobile devices 914.

[0136] The base station receiver 912 can then connect the mobile device 914 to the Internet 908 via a packet-switched link. The Internet 908 can support application services and service layers to deliver data from the measurement system 902 to the mobile device 914. The mobile device 914 can also connect to other communication devices via the Internet 908 using wireless communication channels. The mobile device 914 can also connect to the Internet 908 via a WLAN 910. A wireless local access network (WLAN) provides wireless access within a local geographic area. A WLAN typically consists of a cluster of access points (APs) 916, also known as base stations. The measurement system 902 can communicate with other WLAN stations, such as a laptop 918, within the base station area. In a typical WLAN implementation, the physical layer uses various technologies, such as 802.11b or 802.11g WLAN technologies. The physical layer can use other access technologies such as infrared, frequency hopping spread spectrum in the 2.4 GHz band, direct sequence spread spectrum in the 2.4 GHz band, or the 5.8 GHz ISM band or higher ISM bands (e.g., 24 GHz).

[0137] Through the communications network 900, the measurement system 902 can establish connections with a remote server 920 on the network and with other mobile devices for exchanging data. The remote server 920 can have access to a database 922, which can be stored locally or remotely and contain application-specific data. The remote server 920 can also host application services, either directly or via the Internet 908.

[0138] FIG. 35 is an illustration of a robot 1000 that supports shoulder joint placement, according to an exemplary embodiment. Generally, the robot can support or assist shoulder joint placement under the control of a surgeon. In an exemplary embodiment, a measurement device 154 can be coupled to the robot 1000. One example of a robot is the Robodoc surgical robot with a robot-assisted joint placement application. The robot 1000 can also include a surgical CNC robot, a surgical haptic robot, a surgical telesurgery robot, a surgical handheld robot, or any other surgical robot. The measurement device 154 can be coupled to the robot 1000 and automated to function with the robot, replacing direct manual control by the surgeon. Controlling the measurement device 154 and actions performed by the robot 1000 can be smoother and more accurate by having the robot 1000 use measurement data in real time and provide feedback to the measurement device 154 for subsequent steps. An additional benefit is that the surgical time can be shortened, reducing the time the patient is under anesthesia.

[0139] The robot 1000 can be configured to perform computer-assisted surgery, more specifically, shoulder surgery using the measurement device 154. Typically, the robot 1000 and measurement device 154 are used in computer-assisted surgery to improve performance, alignment, stability, range of motion, reduce surgical time, and minimize impingement in the placement of a prosthetic joint, more specifically, a shoulder joint. In one embodiment, the robot 1000 can use real-time measurement data transmitted from the measurement device 154 to perform distractions, perform bone cuts, align prosthetic components, reposition prosthetic components, adjust loading, perform tissue release, perform range of motion, and improve stability.

[0140] Typically, measurement data from the measurement device 154 can be wirelessly transmitted to the robot 1000's computer. Alternatively, the measurement data can be hardwired to the robot 1000. Examples of measurement data from the measurement device 154 can include range of motion, impingement, load magnitude, load location, position, and movement for a given exercise, to name just a few. The measurement data received by the robot 1000 can be further processed to calculate and display the measurement data needed by the surgeon for bone surface formation or final prosthetic component placement based on the quantitative measurement data. The formed bone surface accepts prosthetic components that support proper alignment for optimal range of motion and stability. In one embodiment, the computer within the robot 1000 includes one or more algorithms used at various stages of surgery. The measurement data from the measurement device 154 is input into the robot 1000's algorithms, which can convert the data into information displayed on a display for robotic actions, such as for performing bone cuts, pin placement, prosthetic component sizing, or to provide feedback for actions the surgeon can take. Feedback can take the form of audible, visual, or tactile feedback to guide the surgeon in distraction or subsequent steps taken by the robot to support or tolerate actions based on the measurement data. Feedback can also smooth or prevent movements by the user that may be detrimental to the procedure. Additionally, the status of the measurement data can be used to generate a workflow that is then implemented by the surgeon or automatically by the robot 1000 to enhance the performance and reliability of shoulder joint placement.

[0141] FIG. 36 is a diagram of a measuring device 1100 according to an exemplary embodiment. The measuring device 1100 contains the same electronic circuitry and at least one sensor as the measuring device 154, as shown in FIGS. 3-21. The measuring device 1100 transmits measurement data to a nearby computer, which displays the measurement data in real time. The measurement data from the measuring device 1100 can be provided on a GUI 380, as shown in FIGS. 22A-27A, disclosed herein above. In this example, the measuring device 1100 is configured for use with a shoulder implant. Generally, the measuring device 1100 can be adapted for use with the musculoskeletal system, such as bones, tissues, ligaments, tendons, or joints. As shown, the measuring device 1100 is configured to couple to a humeral prosthetic material to measure the range of motion, stability, impingement, load, and load location of the shoulder joint. The glenosphere of the shoulder joint is configured to couple to the outer curved surface 1104 of the measuring device 1100. Additionally, any of the embodiments or applications described herein above for measurement device 154 can be applied to measurement device 1100 .

[0142] The measuring device 1100 includes an upper housing 1106 and a lower housing 1108. The upper housing 1106 and the lower housing 1108 are coupled together to form a hermetically sealed enclosure that houses electronic circuitry, a power source, and sensors. The upper housing 1106 has a rim 1102 and an outer curved surface 1104. The measuring device 1100 further includes a shim 1110 configured to couple to the lower housing 1108. The shim 1110 is a removable structure of the measuring device 1100 and is configured to couple to a humeral tray of a humeral prosthesis. To vary the height of the measuring device 1100, multiple shims are provided on the measuring device 1100. In one embodiment, increasing the height of the measuring device 1100 using shims can increase the load exerted by the muscles, tendons, or ligaments of the shoulder joint. Conversely, decreasing the height of the measuring device 1100 using shims of a lower height can decrease the load exerted by the muscles, tendons, or ligaments of the shoulder joint. In one embodiment, multiple shims can be provided to change the angle that the measurement device 1100 presents to the glenosphere when coupled to the shoulder joint.

[0143] FIG. 37A is a top view of the metering device 1100 according to an exemplary embodiment. As previously described, the shim 1110 removably couples to the lower housing 1108. This allows different shims to be quickly coupled to or removed from the metering device 1100 during installation of the shoulder joint, and the quantitative measurement data can be used to determine optimal fit or placement of the humeral prosthetic material within the shoulder joint. A cutout 1112 is shown in the lower housing 1108. In one embodiment, a ledge or protrusion is formed in the lower housing 1108 below the retention feature 1114. The retention feature 1114 is a tab extending from the shim 1110. In one embodiment, the retention feature 1114 couples to the ledge or protrusion of the lower housing 1108 under force, retaining the shim 1110 to the lower housing 1108. In one embodiment, the retaining feature 1114 is flexible so that it can be moved away from a ledge or protrusion on the lower housing 1108, releasing the shim 1110 from the lower housing 1108. A cutout 1112 in the lower housing 1108 is accessible to facilitate flexing of the retaining feature 1114 away from the lower housing 1108.

[0144] 37B is an illustration of a measurement device 1100 showing an exterior curved surface 1104 according to an exemplary embodiment. Generally, an upper housing 1106 of the measurement device 1100 includes a rim 1102 and an exterior curved surface 1104. As previously described, the interface of the glenosphere of the shoulder joint couples to the exterior curved surface 1104 of the measurement device 1100. In one embodiment, multiple sensors are located beneath the exterior curved surface 1104 and are configured to measure force, pressure, or load applied at each location where the sensors are positioned. Measurement data from the multiple sensors is provided to a computer to calculate the magnitude of load applied by the glenosphere of the shoulder joint to the exterior curved surface 1104 and the location of the load applied by the glenosphere.

[0145] 37C is a side view of the metering device 1100 according to an exemplary embodiment. The upper housing 1106 is coupled to the lower housing 1108. The shim 1110 is coupled to the lower housing 1108. The side view shows the undercut 1116 and undercut 1118 in the shim 1110. In one embodiment, the undercut 1118 is also on the opposite side of the shim 1110. The undercuts 1116 and 1118 are used to retain and align the metering device 1100 relative to an implant tray of a humeral prosthetic material. In one embodiment, corresponding features formed in the implant tray mate to the undercuts 1116 and 1118.

[0146] 37D is an anterior view of the metering device 1100 illustrating the undercut 1118 formed in the shim 1110 according to an exemplary embodiment. The undercut 1118 is used to retain and align the metering device 1100 relative to the implant tray of the humeral prosthesis.

[0147] 38 is an exploded view of measurement device 1100 in accordance with an exemplary embodiment. Flexible interconnect 1120 is configured to couple multiple sensors to electronic circuit 1130. The multiple sensors can be formed within or on flexible interconnect 1120. In one embodiment, the multiple sensors include sensor 1122, sensor 1124, and sensor 1126. In one embodiment, sensors 1122, 1124, and 1126 are formed in flexible interconnect 1120. Alternatively, the sensors can be coupled to flexible interconnect 1120. In one embodiment, one or more reference sensors are formed within flexible interconnect 1120. In one embodiment, sensors 1122, 1124, and 1126 and the interconnects within flexible interconnect 1120 are shielded. Sensors 1122, 1124, and 1126 are configured to couple to exterior curved surface 1104.

[0148] The electronic components and power supply 1132 are coupled to a printed circuit board 1128. The printed circuit board 1128 includes one or more levels of interconnects for connecting the electronic components to form an electronic circuit 1130, which is configured to control the measurement process and transmit measurement data. In one embodiment, the power supply 1132 includes a battery to power the measurement device 1100. The printed circuit board 1128 can be a rigid printed circuit board that includes connectors for coupling to the flexible interconnect 1120. The electronic circuit 1130, the flexible interconnect 1120, and the sensors 1122, 1124, and 1126 are disposed within a cavity 1136 in the lower housing 1108. The upper housing 1106 couples to the lower housing 1108 to form a housing for the electronic circuit 1130, the flexible interconnect 1120, and the sensors 1122, 1124, and 1126. In one embodiment, sensors 1122, 1124, and 1126 are positioned at predetermined locations between upper housing 1106 and lower housing 1108 to support measurement of the magnitude and location of applied loads where the glenosphere interfaces with the exterior curved surface 1104 of measurement device 1100 for the shoulder joint. As previously mentioned, electronic circuitry 1130, reference sensors, position measurement system (e.g., IMU), and sensors 1122, 1124, and 1126 operate in a similar manner to that described for measurement device 154 (see FIG. 3 ), and therefore will not be disclosed in detail for the sake of brevity. Furthermore, measurement device 1100 transmits measurement data to computer 162, which displays the measurement data on display 164, as disclosed hereinabove. The measurement data is displayed in a graphical format in GUI 380 to facilitate understanding of the measurement data in the same manner as discussed for measurement device 154.

[0149] The shim 1110 couples to the lower housing 1108 to add height to the measurement device 1100. Multiple shims are provided on the measurement device 1100, with each shim in the plurality having a different thickness. Thus, the shim 1110 can be removed and replaced with one of the other shims from the plurality to change the height of the measurement device 1100 by a predetermined amount. The upper housing 1106, the lower housing 1108, and the shim 1110 can be formed from a biocompatible material, such as a composite, a polymer, a plastic, a metal, or a metal alloy. In one embodiment, the upper housing 1106, the lower housing 1108, and the shim 1110 can be molded or 3D printed from a polymer material.

[0150] The implant tray 1134 is a component of the humeral prosthesis. In one embodiment, the implant tray 1134 couples to the humeral prosthesis. In one embodiment, the implant tray 1134 is held in place on the humeral prosthesis by screws, and the implant tray 1134 can be removed by removing the screws. A shim 1110 is configured to couple to the implant tray 1134 and hold the measurement device 1100 in place to generate quantitative measurement data related to the shoulder joint to assess range of motion, stability, impingement, kinematics, load, or load location.

[0151] 39 is an illustration of a cavity 1136 in the lower housing 1108 of the metering device 1100, according to an exemplary embodiment. In this example, the arrangement of the components of the metering device 1100 is shown. A printed circuit board 1128, including electronic components, is coupled to the inner surface of the lower housing 1108. A printed circuit board 1148 is inserted into the cavity 1136 and retained by printed circuit board snaps 1142. The printed circuit board snaps 1142 are pressed into openings in the printed circuit board 1128, forming an interference fit that prevents movement and aligns the printed circuit board 1128 within the cavity 1136. In one embodiment, the printed circuit board snaps 1142 extend from the inner surface of the lower housing 1108, and the heads of the printed circuit board snaps 1142 are made larger than the openings in the printed circuit board 1128. The printed circuit board 1128 includes a connector 1146 that couples to the flexible interconnect 1120. In one embodiment, a power source 1132 is coupled to and supported by the printed circuit board 1128. The power source 1132 provides power to the electronic circuitry 1130 and sensors 1122, 1124, and 1126 to provide measurement data throughout the shoulder replacement surgery.

[0152] The sensors 1122, 1124, and 1126 are coupled to a surface 1144 on the lower housing 1108 at predetermined locations relative to the outer surface 1104 of the upper housing 1106 (see FIG. 36 ). In one embodiment, the sensors 1122, 1124, and 1126 are positioned at radial locations on the outer curved surface 1106. In one embodiment, the sensors 1122, 1124, and 1126 are equally spaced from one another. In one embodiment, the reference sensor 1148 can be centrally located on or within the flexible interconnect 1120 relative to the sensors 1122, 1124, and 1126. Alternatively, more than one reference sensor can be formed on or within the flexible interconnect 1120. The sensors 1122, 1124, and 1126 are held in place by sensor snaps 1140. Sensor snaps 1140 mate through openings adjacent sensors 1122, 1124, and 1126 to align and hold sensors 1122, 1124, and 1126 in place. In one embodiment, raised areas are formed below sensors 1122, 1124, and 1126. The raised areas extend above surface 1144 and provide a flat surface to support sensors 1122, 1124, and 1126.

[0153] 40 is a cross-sectional view of a metering device 1100 according to an exemplary embodiment. The upper housing 1104 is shown mated to the lower housing 1108. In one embodiment, a circumferential groove 1152 is formed circumferentially on the lower housing 1108. A circumferential tongue 1150 is formed circumferentially on the upper housing 1106 and is configured to mated to the circumferential groove 1152 on the lower housing 1108. In one embodiment, glue or an adhesive may be used in the circumferential groove 1152 to sealingly retain the upper housing 1106 to the lower housing 1108. Alternatively, the upper housing 1106 may be mated to the lower housing 1108 using one or more retaining structures on the upper housing 1106 and one or more corresponding retaining structures on the lower housing 1108. The circumferential tongue 1150 may include a conformal material that forms a seal when the upper housing 1106 is mated to the lower housing 1108.

[0154] A retaining feature 1114 on the upper side of the measuring device 1100 is shown coupling the shim 1110 to the lower housing 1108. Although not shown, there may be more than one retaining feature coupling the shim 1110 to the lower housing 1108. The lower housing 1108 includes a notch 1156 configured to receive the retaining feature 1114. The retaining feature 1114 includes a corresponding protrusion 1154 configured to fit into the notch 1156. As previously described, the retaining feature 1114 is flexible and can be bent away from the lower housing 1108 such that the protrusion 1154 is outside the notch 1156 so that the shim 1110 can be removed from the lower housing 1108.

[0155] The printed circuit board 1130 is retained on or near the inner surface of the lower housing 1108. The flexible interconnect 1120 is shown coupled to a connector 1146 on the printed circuit board 1130. A sensor 1122 formed or disposed within the flexible interconnect is coupled between the upper and lower housings 1106, 1108. In one embodiment, the sensor 1122 couples to a plane formed on the inner surface of the upper housing 1106 and the inner surface of the lower housing 1108. The sensor 1122 is located below a predetermined location on the outer surface 1104. The sensors 1122, 1124, and 1126 in their predetermined locations are used to calculate the location and magnitude of the applied load from the measurement data. Note that the flexible interconnect 1120 does not undergo any bending that would twist the interconnect. A sensor snap 1140 is shown mating through the flexible interconnect 1120 and holding the sensor 1120 in place.

[0156] 41A and 41B illustrate a measurement device 1100 including two different shims, according to an exemplary embodiment. Generally, the measurement device 1100 includes multiple shims. While this example discloses two different shims, more than two different shims can be provided. The shim 1110 is a zero-height shim, representing the measurement device 1100 at its minimum height. In this example, the upper housing 1106 and the lower housing 1108 are coupled together and configured to measure at least one parameter. The shim 1110 is a separate component that couples to the lower housing 1108. The measurement device 1100 is shown with the shim 1110 coupled to the lower housing 1108 to form the measurement device 1100 at a standard, normal, or minimum height.

[0157] The shim 1160 is a 2.5 millimeter shim that increases the height of the measuring device 1100 by 2.5 millimeters when compared to the zero-height shim 1110 of FIG. 41A . In this example, the upper housing 1106 and the lower housing 1108 are coupled together and configured to measure at least one parameter. The shim 1160 is a separate component that couples to the lower housing 1108. The measuring device 1100 is shown coupled to the shim 1160 to the lower housing 1108 to form the measuring device 1100 with an increased height of 2.5 millimeters. As previously described, the measuring device 1100 can be provided with more than two shims of different heights. For example, a shoulder joint reduced by the shim 1110 of FIG. 41A may have less than desirable loads when measured by the measuring device 1100. The shim 1110 can then be removed and replaced with the shim 1160. Reducing the shoulder joint with the shim 1160 in the measuring device 1100 increases the tension on the muscles of the shoulder joint, thereby increasing the load applied to the measuring device 1100. The tension on various muscles, ligaments, or tendons can be adjusted to achieve stability, maximize range of motion, minimize impingement, and load the shoulder joint within an acceptable range based on quantitative measurement data. For example, this tension can be adjusted using soft tissue tension to adjust the load within an acceptable range as measured in real time by a load sensor in the measuring device 1100.

[0158] 42 is a cross-sectional view of the outer curved surface 1104 of the upper housing 1106 that has been modified to apply loads directly to predetermined areas of the outer curved surface 1104, according to an exemplary embodiment. The cross-sectional view shows the upper housing 1106 coupled to the lower housing 1108 to form a housing that hermetically isolates and seals the electronic circuitry 1130, flexible interconnect 1120, and sensors 1122, 1124, and 1126 from the external environment. A shim 1110 couples to the lower housing 1108. A partial view of the glenosphere 1194 is shown coupled to the outer curved surface 1104 of the upper housing 1106. Generally, loads from the glenosphere 1194 are directed to multiple load sensors located beneath the outer curved surface 1104. In this example, the loads are directed to sensors 1122, 1124, and 1126 (not shown). As shown, sensors 1122 and 1124 are located under regions 1172 and 1174, respectively, of outer curved surface 1104. Similarly, sensor 1126 is located under region 1176 in FIG. 42 . As previously mentioned, sensors 1122, 1124, and 1126 are positioned at predetermined radial locations on outer curved surface 1104. In one embodiment, sensors 1122, 1124, and 1126 are also equally spaced from one another. Sensors 1122, 1124, and 1126 are positioned as close to the rim 1102 of upper housing 1106 as feasible to maximize the measurement area on outer curved surface 1104.

[0159] In this example, the glenosphere 1194 is 38 millimeters in diameter and has a radius of 19 millimeters. In one embodiment, the exterior curved surface 1104 has a larger radius than the glenosphere 1194. In this example, the radius of the exterior curved surface is 38.15 millimeters. The exterior curved surface 1104 is modified so that only the glenosphere 1194 couples to regions 1172, 1174, and 1176 of the exterior curved surface 1104. The sensors 1122, 1124, and 1126 are located below regions 1172, 1174, and 1176 of the exterior curved surface 1104, respectively. Therefore, loads exerted by the glenosphere 1194 are directed to the sensors 1122, 1124, and 1126 of the measurement device 1100, rather than to areas of the exterior curved surface 1104 outside of regions 1172, 1174, and 1176. Generally, there are two regions on the exterior curved surface 1104 that do not bond to the glenosphere 1194. In one embodiment, region 1192 of the exterior curved surface 1104 of the upper housing 1106 does not bond to the glenosphere 1194. Note that a gap is shown between the glenosphere 1194 and the exterior curved surface 1104 in region 1192. Region 1192 corresponds to the load measurement area between sensors 1122, 1124, and 1126. In one embodiment, the gap between the glenosphere 1194 and the exterior curved surface 1104 in region 1192 is approximately 0.15 millimeters. In one embodiment, region 1192 can be molded with a 0.15 millimeter cutout in region 1192. Alternatively, 0.15 millimeters of material can be removed from region 1192.

[0160] In one embodiment, region 1190 of exterior curved surface 1104 of upper housing 1106 does not bond to glenosphere 1194. Note that a gap is shown between glenosphere 1194 and exterior curved surface 1104 in region 1130. Region 1190 corresponds to the area of ​​exterior curved surface 1104 outside of region 1192, as well as regions 1172, 1174, and 1176. In one embodiment, the gap between glenosphere 1194 and exterior curved surface 1104 in region 1190 is approximately 0.10 millimeters. In one embodiment, region 1190 can be molded with a 0.10 millimeter cutout. Alternatively, 0.10 millimeters of material can be removed from region 1190.

[0161] FIG. 43 is a block diagram of loading the measurement device 1100 according to an exemplary embodiment. This method references the components listed in FIG. 42. In step 1180, the glenosphere 1194 of the shoulder joint applies a load to the measurement device 1100. In this example, the glenosphere 1194 couples to the scapula and the measurement device 1100 couples to the humeral prosthesis, forming the shoulder joint. In step 1182, the glenosphere 1194 couples directly to regions 1172, 1174, and 1176. The sensors 1122, 1124, and 1126 are located below regions 1172, 1174, and 1176, respectively, of the outer curved surface 1104 of the upper housing 1106. In one embodiment, the glenosphere 1194 is not coupled to regions 1190 and 1192 of the outer curved surface 1104 of the upper housing 1106. The load applied by the glenosphere 1194 is coupled through and distributed among sensors 1122, 1124, and 1126. In step 1186, the intended sensitivity of the sensors is corrected by distributing the load through regions 1172, 1174, and 1176, and thus through sensors 1122, 1124, and 1126. In one embodiment, the load applied by the glenosphere 1194 to the measurement device 1100 is coupled only through sensors 1122, 1124, and 1126.

[0162] FIG. 44 is an illustration of the measurement device 1100 showing different regions of the outer curved surface 1104 of the upper housing 1106, according to an exemplary embodiment. Generally, the outer curved surface 1104 includes three different regions, each having a different surface height. The first region corresponds to the location of a sensor for measuring force, pressure, or load applied to the outer curved surface 1104. The surface height and curvature of the first region correspond to the radius configured to receive a spherical prosthetic component. In this example, the glenoid sphere has a radius of 19 millimeters, and the radius of the first region, corresponding to the location of the sensor, is 19.075 millimeters. In one embodiment, the outer curved surface 1104 has a larger radius than the spherical prosthetic component that will be coupled to it.

[0163] The second region of the outer curved surface 1104 corresponds to the location of a spherical prosthetic component load applied to the outer curved surface 1104. Typically, the sensor is located adjacent to or proximate to the rim 1102 of the upper housing 1106. Locating the sensor proximate to the rim 1102 maximizes the area over which the sensor can accurately measure the location of the applied load. In one embodiment, the sensor is located at a radial position on the outer curved surface 1104. In one embodiment, the sensors are equally spaced from each other. In one embodiment, the second region can be located at or below the sensor location. In one embodiment, the second region can be irregularly shaped. In one embodiment, the second region can include more than one second region. In this example, the surface of the second region of the outer curved surface 1104 is below the surface of the first region. In one embodiment, the spherical prosthetic component does not bind to the second region when coupled to the outer curved surface 1104. The spherical prosthetic component binds to the first region corresponding to the sensor location.

[0164] The third region of the exterior curved surface 1104 corresponds to a location of the applied load that is proximate to the sensor or above the sensor on the exterior curved surface 1104. In one embodiment, the range of motion of the spherical prosthetic component when coupled to the exterior curved surface 1104 does not typically place the location of the applied load near the rim 1102 of the upper housing 1106. Generally, the third region corresponds to an extreme value of the range of motion for the prosthetic joint. In one embodiment, the third region can be located proximate to or above the sensor location. In one embodiment, the third region can be irregularly shaped. In one embodiment, the third region can include more than one third region. In this example, the third region of the exterior curved surface 1104 is outside the second region of the exterior curved surface 1104 but does not include the first region. In one embodiment, the spherical prosthetic component does not couple to the third region when coupled to the exterior curved surface 1104. The spherical prosthetic component couples to the first region, which corresponds to the sensor location. In this example, the surface of the third region is below the surface of the first region. In one embodiment, the surface of the second region is below the surface of the third region.

[0165] In this example, a circle 1196 is drawn on exterior curved surface 1104 to define a boundary identifying region 1190 and region 1192. Region 1192 corresponds to the second region of exterior curved surface 1104 disclosed hereinabove. Region 1192 is the region of exterior curved surface 1104 that is within circle 1196. Region 1190 corresponds to a third region of exterior curved surface 1104. In one embodiment, region 1190 is the region of exterior curved surface 1104 that is outside of circle 1196 but does not include regions 1172, 1174, and 1176 up to rim 1102. As previously discussed, sensors 1122, 1124, and 1126 shown in FIG. 39 are located below regions 1172, 1174, and 1176, respectively. In one embodiment, regions 1172, 1174, and 1176 have areas greater than or equal to the areas of sensors 1122, 1124, and 1126. In one embodiment, regions 1172, 1174, and 1176 include curved surfaces configured to interface with glenosphere 1194 of FIG. 42. In this example, regions 1172, 1174, and 1176 have curved surfaces corresponding to a radius of 19.075 millimeters, while the glenosphere has a radius of 19 millimeters. The surface of region 1192 of outer curved surface 1104 is below the surfaces of regions 1172, 1174, and 1176. In this example, the surface of region 1192 is 0.15 millimeters below the surfaces of regions 1172, 1174, and 1176, so when glenosphere 1194 of FIG. 42 is coupled to measurement device 1100, glenosphere 1194 does not couple to region 1192. The surface of region 1190 of outer curved surface 1104 is below the surfaces of regions 1172, 1174, and 1176. In this example, the surface of region 1190 is 0.10 millimeters below the surfaces of regions 1172, 1174, and 1176, so when glenosphere 1194 is coupled to measurement device 1100, glenosphere 1194 does not couple to region 1190. In this example, the surface of region 1190 is above the surface of region 1192 with respect to regions 1172, 1174, and 1176.In one embodiment, the outer curved surface 1104 has regions 1190, 1192, 1172, 1174, and 1176 to which loads applied by the glenosphere 1194 via sensors 1122, 1124, and 1126 are directed to provide the desired sensitivity to the measurement system.

[0166] Briefly referring to Figures 1-3, a shoulder joint system 160 is disclosed that includes a first shoulder prosthesis and a second shoulder prosthesis. Generally, the shoulder joint system 160 can be used in a reverse shoulder prosthesis or a conventional shoulder prosthesis. The electronics and sensors can be housed in either the prosthetic components that couple to the humerus, the prosthetic components that couple to the scapula, or both. In one embodiment, the first shoulder prosthesis is a humeral prosthesis 158 configured to couple to the humerus 150. The humeral prosthesis 158 includes a stem 124, a neck 126, and a tray 156. In one embodiment, the second shoulder prosthesis is a glenosphere 152 configured to couple to the scapula 140. The humeral prosthesis 158 and the glenosphere 152 each include external curved surfaces that mate with each other to support movement and rotation of the shoulder joint. Alternatively, in a conventional shoulder prosthesis, the first shoulder prosthesis is a glenoid prosthesis material 114 and the second shoulder prosthesis is a humeral prosthesis material 102 .

[0167] During the testing process, the humeral liner 128 of the humeral prosthesis material 158 is removed and replaced with a measuring device 154, which takes one or more measurements and supports placement of the shoulder joint system 160. The measuring device 154 has an exterior curved surface that is configured to mate with the glenosphere 152 and support the motion of the shoulder joint system. In one embodiment, the measuring device is the same dimensions as the humeral liner that couples to the humeral tray 156. Briefly referring to FIGS. 5-21 , electronic circuitry and multiple sensors are shown on the measuring device 154. In particular, FIGS. 5 and 6 show the measuring device 154, which includes an upper housing 220 and a lower housing 222. Three sensors 230 are shown positioned at different radial locations below the exterior curved surface 224 of the upper housing 220. The upper housing 220 couples to the lower housing 222 to form a hermetic seal that houses the electronic circuitry and multiple sensors. In one embodiment, the hermetic seal is formed by an O-ring or adhesive bonding between the upper housing 220 and the lower housing 222. Referring briefly to FIG. 16 , the upper housing 220 of the measuring device 154 is coupled to the lower housing 222 using one or more housing snaps 278. In one embodiment, the housing snaps 278 include protrusions formed on the sidewalls 328 of the lower housing 222 and corresponding openings formed in the upper housing 220. The region of the upper housing 220 including the openings is configured to flex, allowing the upper housing 220 to be forced against the lower housing 222 until the openings cover the corresponding housing snaps 278. The one or more housing snaps 278 preload the multiple sensors when the upper housing 220 is coupled to the lower housing 222. Referring briefly to FIG. 29B , the multiple sensors are each positioned at a radial position relative to the exterior curved surface of the measuring device 154. In one embodiment, three sensors are positioned at three different radial positions. Referring briefly to Figure 31, force sensors 530, 532, and 534 are oriented so that the reaction force is directed toward the center of rotation of the shoulder prosthesis. A block diagram of the electronics 236 of the measurement device 154 is disclosed in Figure 32.The electronic circuitry 236 is operatively coupled to the plurality of sensors in the measurement device 154. The electronic circuitry 236 controls the measurement process and transmits the measurement data.

[0168] Referring briefly to FIG. 19 , a flexible interconnect 228 couples the plurality of sensors 230 to electronic circuitry 236. Referring briefly to FIG. 14 , the flexible interconnect 228 couples the plurality of sensors 230 to a support structure 262 to position the plurality of sensors 230 relative to the curved exterior surface of the upper housing 220. In one embodiment, the flexible interconnect 228 couples to the inner surface 244 of the lower housing 222. In one embodiment, the flexible interconnect 228 couples to the support structure 262 at an angle such that the surface of the support structure 262 is not parallel to the inner surface 244 of the lower housing 222. In one embodiment, the support structure 262 positions the plurality of sensors 230 for coupling between the upper and lower housings 220 and 222. Each sensor of the plurality of sensors 230 lies below the curved exterior surface of the upper housing 220 at a predetermined location as discussed herein. Each sensor of the plurality of sensors 230 couples to a flat surface on the interior of the upper housing and a flat surface on the lower housing, respectively. In one embodiment, the three load sensors are placed equidistant from each other.

[0169] The electronic circuitry 236 and the plurality of sensors transmit measurement data to the computer 162 of FIG. 32. The computer 162 is configured to receive measurement data from the shoulder system, which includes the measurement device 154, but may include sensors in other components of the shoulder system. The electronic circuitry 236 of the first shoulder prosthesis and the computer 162 are capable of bidirectional communication. In one embodiment, three load sensors are configured to measure loads applied to the first shoulder prosthesis. In one embodiment, the computer 162 is configured to calculate a force magnitude and a position of the applied force using measurements and positions of the first, second, and third sensors under the outer curved surface of the measurement device 154. In one embodiment, the force applied to the outer curved surface of the measurement device 154 is perpendicular to the outer curved surface. In one embodiment, a display is coupled to the computer 162. The display is configured to show at least one magnitude of the load applied to the outer curved surface of the first shoulder prosthesis in real time. Generally, the force applied to the first shoulder prosthesis by the second shoulder prosthesis is perpendicular to the outer curved surface of the first shoulder prosthesis. In one embodiment, the multiple load sensors are oriented so that the reaction force is directed towards the center of rotation.

[0170] 22a, a display 164 coupled to the computer 162 is configured to graphically display an exterior curved surface 384 corresponding to the exterior curved surface of the upper housing. The computer 162 is configured to receive measurement data from the measurement device 154. The computer 162 can perform calculations related to the measurement data from one or more sensors. Furthermore, the computer 162 can convert the measurement data into a graphical format that allows a surgeon or surgical team to quickly understand the measurement data. The display 164 is coupled to the computer 162, which includes a graphical user interface (GUI) 380. The GUI 380 is configured to provide an image of the exterior curved surface 384 of the measurement device 154 and a rim surrounding the exterior curved surface 384.

[0171] The display 164 is configured to graphically display, in real time, the contact points 382 on the upper housing where the glenosphere 152 interfaces with the outer curved surface of the upper housing. In one embodiment, the glenosphere 152 applies a force to the measurement device 154 perpendicular to the outer curved surface 224. The display also shows the contact points on the outer curved surface of the first shoulder prosthesis. As the shoulder moves through various ranges of motion, the contact points move in real time on the display. In one embodiment, the display and computer are located in the operating room and provide real-time information to the surgical team. Other measurements taken of the shoulder system 160 include motion, position, joint stability, range of motion, or impingement, to name just a few. Referring briefly to FIG. 22B, the computer 162 is configured to calculate the time of impingement from the measurement data. In one embodiment, the display 164 indicates the time of impingement by highlighting the rim 520 of the outer curved surface of the upper housing. Rim 520 highlights the portion of the rim where impingement occurs or the portion of the rim corresponding to the end of the range of motion direction where impingement occurs.

[0172] In one embodiment, one or more motion bars are displayed on the display 164. The one or more motion bars are configured to graphically indicate the range of motion of the shoulder joint system as it moves through a predetermined motion. Briefly referring to FIG. 23 , four motion bars (400, 402, 404, and 406) are disclosed, each corresponding to a specific motion. Each motion bar graphically indicates the range of motion achieved by the shoulder joint system installation for the predetermined motion. Each motion bar has a first end and a second end. The first and second ends of the motion bar correspond to maximum internal rotation for the predetermined motion and maximum external rotation for the predetermined motion. Between the first and second ends, the motion bars are configured to indicate the allowable internal range of motion and the allowable external range of motion for the predetermined motion. The motion bars are also configured to indicate the center of the predetermined motion. In one embodiment, the bars indicate the position of the shoulder during the predetermined motion. For example, bar 426 of motion bar 402 indicates the position of the shoulder during I / E rotation with 45 degrees of adduction. A box 428 on the display indicates, via a color map, the load applied to the outer curved surface of the measurement device over a given movement.

[0173] Briefly referring to FIG. 25 , a range of motion (ROM) overlay 390 on a GUI 380 is disclosed. The motion and load data from the predetermined motion of FIG. 23 are stored in memory. In FIG. 25 , the GUI 380 graphically displays the movement of a contact point 382 to an outer curved surface 384 on the GUI 380 for each of the four different shoulder joint motions measured in FIG. 23 . The trace of the predetermined motion on the outer curved surface of the measurement device as shown in FIG. 25 is the ROM overlay. The GUI 380 is configured to provide at least one ROM overlay on an image of the outer curved surface of the measurement device on a computer display. In other words, the ROM overlay includes at least one load track corresponding to the predetermined motion of the shoulder joint. In one embodiment, the applied load can vary significantly at different points on the load track. In one embodiment, the GUI 380 is configured to provide at least one impingement ROM assessment including traces indicating limits of abduction / adduction and horizontal flexion.

[0174] In one embodiment, the GUI 380 is configured to provide an image of the outer curved surface of the measurement device and a rim surrounding the outer curved surface. A portion of the rim is highlighted when impingement occurs and corresponds to the direction of shoulder joint movement. The GUI 380 is configured to provide at least one impingement ROM assessment, including traces indicating limits of abduction / adduction and horizontal flexion.

[0175] Referring briefly to FIG. 3 , a shoulder system 160 is disclosed. The shoulder system 160 includes a first prosthetic component and a second prosthetic component. The shoulder system 160 is configured to transmit measurement data to a computer 162 and display the measurement data on a display 164. The first prosthetic component and the second prosthetic component each have curved surfaces that are configured to fit together to support the shoulder system 160. The curved surfaces of the first and second prosthetic components allow for a wide range of motion for the shoulder joint. In one embodiment, the first prosthetic component is a humeral prosthetic material 158 configured to couple to the humerus 150. In one embodiment, the second prosthetic component is a glenosphere 152 configured to couple to the scapula 140. The humeral prosthetic material 158 includes a humeral tray 156. A humeral liner or measurement device 154 is configured to couple to the humeral tray 156. Referring briefly to FIG. 36 , a metering device 1100 is disclosed. The metering device 1100 includes an upper housing 1106, a lower housing 1108, and a shim 1110. The metering device 1100 or the metering device 154 is configured to couple to a humeral tray 156 to provide measurement data. The shim 1110 is a removable device for adjusting the height of the metering device 1100. For example, adding height can increase the force applied to the metering device 1100 when the metering device 1100 is placed in a joint. Conversely, removing the shim or replacing it with a thinner shim decreases the force applied to the metering device 1100 when the metering device 1100 is placed in a joint. In one embodiment, the shim 1110 couples to the lower housing 1108 and retains the metering device 1100 to the humeral tray 156. The upper housing 1106 includes an outer curved surface 1104 configured to couple to another prosthetic component to support joint motion. An upper housing 1106 is bonded to a lower housing 1108 to form a hermetically sealed enclosure.The hermetically sealed housing contains at least one sensor and electronic circuitry configured to control the measurement process and transmit measurement data. In one embodiment, a shim 1110 is configured to couple to the lower housing 1108. In one embodiment, the shim 1110 is configured to couple the measurement device 1100 to a humeral tray of a humeral prosthesis. Although not shown, the shim 1110 is used for the measurement device 154 to change the height of the measurement device 154 and adjust the load applied to the prosthetic component. In one embodiment, the measurement device 1100 with the shim 1110 couples to the humeral tray 156 of FIG. 3. In one embodiment, multiple shims are provided, each shim having a different height to adjust the height of the measurement device 1100. Each shim of the multiple shims is configured to couple to the measurement device 1100. Further, each shim is configured to couple to the tray of the prosthetic component. In one embodiment, each shim of the plurality of shims includes one or more cutouts that retain one shim of the plurality of shims in the tray of the prosthetic component.

[0176] In general, everything disclosed herein with respect to measurement device 154 above also applies to measurement device 1100. In other words, the electronic circuits, sensors, or structures of measurement device 154 also apply to measurement device 1100. Although not shown, the electronic circuits disclosed herein with respect to measurement device 154 above are also present in measurement device 1100. Accordingly, figures related to measurement device 154 will be disclosed when discussing structures, electronic circuits, or sensors for measurement device 1100. Electronic circuit 236 is disclosed in FIG. 32. Electronic circuit 236 is disposed within an enclosure formed by coupling upper housing 1106 to lower housing 1108. Referring briefly to FIG. 19, first, second, and third sensors are disposed within lower housing 222, which corresponds to lower housing 1108. The first, second, and third sensors correspond to sensor 230. Referring to FIG. 5, upper housing 220, which corresponds to upper housing 1106, is shown prior to coupling to lower housing 222. By coupling upper housing 220 to lower housing 222, first, second, and third sensors are coupled to outer curved surface 224, respectively, corresponding to outer curved surface 1104. More specifically, when coupled to lower housing 222, first, second, and third sensors are coupled to outer curved surface 224 at a first predetermined radial position, a second predetermined radial position, and a third predetermined radial position of upper housing 220, respectively. Referring briefly to FIG. 28, a view of sensors 530 and 532 is shown in cross section to illustrate the radial positions. A third sensor (not shown) is spaced such that all three sensors are equally spaced. In other words, the first, second, and third predetermined radial positions have equal radii from the center of curvature. In one embodiment, the first, second, and third radial positions of sensors 530, 532, and 534 on outer curved surface 224 have radii that are greater than the radius of the outer curved surface of the prosthetic component that couples to measuring device 154. In one embodiment, the first, second, and third sensors are located at or near the rim of the outer curved surface, hi one embodiment, the locations of the first, second, and third sensors have equal radii relative to the outer curved surface.

[0177] Generally, the measuring device 1100 couples to a first prosthetic component to generate measurement data related to the shoulder joint system. The measuring device 1100 of the first prosthetic component couples to the outer curved surface of the second prosthetic component, as disclosed in FIGS. 1-3. In one embodiment, the outer curved surface of the second prosthetic component is configured to couple to the outer curved surface of the upper housing 220 of the measuring device 154 only at predetermined first, second, and third radial locations corresponding to the locations of the first, second, and third sensors, respectively, below the outer curved surface of the upper housing. Forces applied by the second prosthetic shoulder to the first prosthetic shoulder are conducted via the first, second, and third sensors. As described above, the electronic circuit 236 couples to the first, second, and third sensors. The electronic circuit 236 is configured to control the measurement process and transmit the measurement data.

[0178] Referring briefly to FIG. 44 , a measurement device 1100 is shown disclosing different regions of the exterior curved surface 1104 of the upper housing 1006. The regions disclosed herein also correspond to the measurement device 154. The regions correspond to locations on the exterior curved surface 1104 where forces, pressures, or loads are measured. In one embodiment, the regions correspond to first, second, and third sensors beneath the exterior curved surface 1104. Regions 1172, 1174, and 1176 correspond to regions of the exterior curved surface 1104 and are located at predetermined first, second, and third radial locations. In one embodiment, regions 1172, 1174, and 1176 correspond to surfaces at predetermined first, second, and third radial locations on the exterior curved surface 1104 of the measurement device 1100. Regions 1172, 1174, and 1176 are equal to or greater than the areas of the first, second, or third sensors beneath the radial locations. A first region of the exterior curved surface 1104 is associated with a circle 1196 shown in FIG. 44 . In one embodiment, the first region is the region within the circle 1196 of the exterior curved surface 1104 of the measuring device 1100. The first region is shown as region 1192. In one embodiment, surfaces at predetermined first, second, and third radial locations corresponding to regions 1172, 1174, and 1176 are above the surface of the first region (region 1192) of the exterior curved surface 1104 within the circle 1196. A second region of the exterior curved surface 1104 of the measuring device 1100 corresponds to the region outside of the circle 1196, but does not include regions 1172, 1174, and 1176. The second region is shown as region 1190. The second region extends from the circle 1196 to the rim 1102 of the measuring device 1100, excluding regions 1172, 1174, and 1176. In one embodiment, the surface at predetermined first, second, and third radial locations corresponding to regions 1172, 1174, and 1176 is above the surface of the second region (region 1190). In one embodiment, the surface of the second region of outer curved surface 1104 comprises an area above the surface of the first region of outer curved surface 1104. In one embodiment, rim 1102 of measuring device 1100 is the maximum height of outer curved surface 1104. Conversely, the first region, corresponding to the area of ​​the surface within circle 1196, is the lowest portion of outer curved surface 1104 of measuring device 1100.

[0179] A method for measuring within a shoulder joint is provided herein below. The disclosed steps can be performed independently and in any order. The order of the steps does not imply a sequence or order, but is merely for identifying the steps. In a first step, a first shoulder prosthesis is coupled to a second shoulder prosthesis. The first shoulder prosthesis has an external curved surface configured to couple to the external curved surface of the second shoulder prosthesis. In one embodiment, the external curved surface of the first shoulder prosthesis is a measurement device, and the measurement device is configured to control the measurement process and transmit measurement data to a computer. The computer includes a display for displaying the measurement data or for graphically displaying information related to the measurement data. In a second step, a force, pressure, or load on the second shoulder prosthesis is conducted via a surface at a predetermined first radial position, a surface at a predetermined second radial position, and a surface at a predetermined third radial position of the first shoulder prosthesis. Underlying the surface at the predetermined first radial position, the surface at the predetermined second radial position, and the surface at the predetermined third radial position are a first sensor, a second sensor, and a third sensor, respectively. In the third step, the first, second, and third sensors are positioned equidistant from one another at positions that maximize the radius of the circle defined by the sensors. The first, second, and third sensors are oriented so that the reaction forces of the sensors are directed toward the center of curvature of the outer curved surface of the first shoulder prosthesis. In one embodiment, it is assumed that there is no or negligible friction force on the outer curved surface of the first shoulder prosthesis or at the sensor interface. In one embodiment, it is assumed that the reaction force vector is perpendicular to the outer curved surface of the first shoulder prosthesis and passes through the center of curvature of the outer curved surface of the first shoulder prosthesis.

[0180] It should be noted that little data exists regarding implanted orthopedic devices. Most data has been obtained empirically by analyzing orthopedic devices used in human subjects or simulated applications. Wear patterns, material issues, and failure mechanisms have been studied. While information can be gathered through these types of studies, substantial data regarding initial installation, postoperative use, and long-term use from a metrology perspective has not been obtained. Just as each individual is different, so too is the installation of each device, with variations in initial loading, balance, and alignment. Measuring data and using that data to install orthopedic devices greatly improves the consistency of implant procedures, thereby reducing rework and maximizing device longevity. In at least one exemplary embodiment, the measured data is collected in a database, where it can be stored and analyzed. For example, relevant samples of measured data can be collected and used to define optimal initial measurement settings, geometry, and alignment to maximize the longevity and utility of implanted orthopedic devices.

[0181] The present invention is applicable to a wide range of medical and non-medical applications, including, but not limited to, frequency compensation, or control of or alarming of physical systems, or monitoring or measuring physical parameters of interest. The level of accuracy and repeatability achievable with a very compact measurement device or surgical instrument may be applicable to many medical applications that monitor or measure physiological parameters throughout the human body, including, but not limited to, bone density, various fluid motions, viscosities and pressures, and local temperature, as applied to vascular, lymphatic, respiratory, digestive systems, muscles, bones, and joints, other soft tissue regions, and interstitial fluids.

[0182] While the present invention has been described with reference to particular embodiments, those skilled in the art will recognize that many modifications can be made thereto without departing from the spirit and scope of the invention. Each of these embodiments and obvious variations thereof is contemplated as being within the spirit and scope of the claimed invention, as set forth in the following claims. While the inventive subject matter has been described with particular example embodiments, the foregoing drawings and description thereof illustrate only general embodiments of the inventive subject matter and therefore should not be considered as limiting its scope, as it is apparent that many alternatives and variations will be apparent to those skilled in the art. Thus, because the description of the present invention is merely illustrative in nature, variations that do not depart from the spirit of the invention are intended to be within the scope of the embodiments of the present invention. Such variations should not be considered as a departure from the spirit and scope of the present invention.

[0183] While the present invention has been described with reference to embodiments, it should be understood that the invention is not limited to the disclosed embodiments. The following claims should be accorded the broadest interpretation so as to encompass all modifications, equivalent structures, and functions. For example, when words such as "orthogonal" and "vertical" are used, the intended meaning is "substantially orthogonal" and "substantially vertical," respectively. Furthermore, although specific numbers may be recited in the claims, numbers approximating those recited are also intended to be within the intended range. That is, any recited number (e.g., 90 degrees) should be interpreted as being "approximately" the recited number (e.g., about 90 degrees).

[0184] As the following claims reflect, inventive aspects may comprise less than all features of a single foregoing disclosed embodiment. Accordingly, the claims expressed below are hereby expressly incorporated into this Detailed Description of the Drawings, with each claim standing on its own as a separate embodiment of invention. Moreover, some embodiments described herein include some features but not other features that are included in other embodiments, and combinations of features from different embodiments are meant to form different embodiments within the scope of the present invention, as understood by those skilled in the art.

Claims

1. A joint measurement system, comprising: a remote system configured to receive measurement data from a measurement device, the measurement device being proximate to or at a joint; and a display for displaying the measurement data; the display includes a graphical user interface (GUI); the GUI is configured to provide a display of one or more indicators; the one or more indicators are associated with one or more of movement, position, and impingement; the one or more indicators are determined based on the measurement data received by the remote system; the display of the one or more indicators includes a display of a motion bar corresponding to a preset movement of a joint, the display of the motion bar being configured to graphically indicate a range of motion of the joint; A joint measurement system, wherein the representation of the motion bar includes dashed lines indicating an allowable range of motion for a preset movement.

2. The joint measurement system of claim 1 , wherein the representation of the motion bar is configured to indicate a position of a shoulder joint.

3. 3. The joint measurement system of claim 2, wherein the display of the motion bar is further configured to display color scale or gray scale regions within the motion bar, the color scale or gray scale regions visually representing one or more parameters of the joint.

4. A joint measurement system, a remote system configured to receive measurement data from a measurement device, the measurement device being proximate to or at a joint; and a display for displaying the measurement data; the display includes a graphical user interface (GUI); the GUI is configured to provide a display of one or more indicators; the one or more indicators are associated with one or more of movement, position, and impingement; the one or more indicators are determined based on the measurement data received by the remote system; the display of the one or more indicators includes displaying an image of an exterior surface of the gauging device; the display of the one or more indicators further includes displaying contact points on the image of the exterior surface of the gauging device; the contact point is determined from the measurement data; The position of the contact point is updated in real time; the indicia of the one or more indicators includes an indicia of a rim surrounding the exterior surface of the metering device; a portion of the rim is highlighted when impingement occurs; The highlighted portion of the rim corresponds to where impingement occurs.

5. 5. The articulation measurement system of claim 4, wherein the highlighted portion of the rim is displayed as a particular color indicative of impingement severity, the particular color corresponding to one or more different levels of impingement severity.

6. The articulation measurement system of claim 4 , wherein the display of the one or more indicators includes displaying a text or graphic indication adjacent the highlighted portion of the rim.

7. A joint measurement system, a remote system configured to receive measurement data from a measurement device, the measurement device being proximate to or at a joint; and a display for displaying the measurement data; the display includes a graphical user interface (GUI); the GUI is configured to provide a display of one or more indicators; the one or more indicators are associated with one or more of movement, position, and impingement; the one or more indicators are determined based on the measurement data received by the remote system; 10. A joint measurement system, wherein the display of the one or more indicators includes a range of motion (ROM) display, the ROM display including at least one load track corresponding to a preset movement of the joint.

8. The joint measurement system of claim 7 , wherein the display of the one or more indicators includes a display of a plurality of load tracks, each load track corresponding to a particular movement of the joint.

9. 8. The joint measurement system of claim 7, wherein the displayed ROM is configured to include color scale or grayscale shading along each load track, the color scale or grayscale shading representing changes in one or more parameters of the joint at a plurality of specific locations along the load track.

10. A joint measurement system, a remote system configured to receive measurement data from a measurement device, the measurement device being proximate to or at a joint; and a display for displaying the measurement data; the display includes a graphical user interface (GUI); the GUI is configured to provide a display of one or more indicators; the one or more indicators are associated with one or more of movement, position, and impingement; the one or more indicators are determined based on the measurement data received by the remote system; The display of the one or more indicators includes a display of a range of motion (I-ROM) assessment characteristic including a graph representing a range of motion of the joint during impingement assessment.

11. The joint measurement system of claim 10 , wherein the graph displayed in the I-ROM assessment characteristic includes a trace representing the position of the joint.

12. 11. The articular measurement system of claim 10, wherein the GUI further comprises a track button operable to toggle between collecting data for a trace and resetting the trace for new data collection in the I-ROM assessment.

13. A joint measurement system, comprising: a remote system configured to receive measurement data from the measurement device; a display for displaying the measurement data; the display includes a graphical user interface (GUI); the GUI is configured to display an image of an exterior surface of the measurement device; the GUI is configured to display a rim surrounding the exterior surface of the measurement device; a portion of the rim is highlighted when impingement occurs, the highlighted portion of the rim corresponding to the location where the impingement occurred; The highlighted portion of the rim is determined from the measurement data.

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