Abstract: A measurement device suitable to measure a load applied by the muscular-skeletal system is disclosed. The measurement device can be a prosthetic component having an articular surface for measuring parameters of a joint in extension or flexion. A first and second support structure forms an enclosure having load-bearing surfaces. The first support structure includes at least one alignment feature extending from a surface. The second support structure includes a corresponding opening for receiving the alignment feature. The first and second support structures include a peripheral channel and corresponding flange to support sealing of the enclosure. Interior to the enclosure is the measurement system. The alignment feature couples through and aligns a first load plate, a sensor array, and a second load plate to surfaces of the first and second support structures. The sensor array is coupled to electronic circuitry in the enclosure via a unitary circuit board.

Abstract: A sensing assemblage for capturing a transit time, phase, or frequency of energy waves propagating through a medium is disclosed to measure a parameter of the muscular-skeletal system. The sensing assemblage comprises a transducer and a waveguide. The transducer is coupled to the waveguide at a first location. A reflective surface can be coupled to the waveguide at a second location. The reflective surface is configured to reflect energy waves away from the reflective surface. An interface material that is transmissive to acoustic energy waves can be placed between the transducer and a waveguide to improve transfer.

Abstract: An alignment system for the muscular-skeletal system is disclosed. The system supports parameter measurement and alignment. The system comprises a sensored device, a reference position tool, and a remote system configured to receive and display sensor data. The sensored device includes a three-axis accelerometer configured to measure position, rotation, and slope. The reference position tool comprises a body, a first arm coupled to a proximal end of the body, and a second arms coupled to a proximal end of the body. The sensored device couples to the reference position tool. The first and second arms of the reference position tool couples to the muscular-skeletal system in predetermined locations to allow a position of the muscular-skeletal system to be referenced. The body of the reference position tool can extend and retract to adapt to different sized muscular-skeletal systems.

Abstract: A system for enabling and disabling a medical device. The system includes a cradle having a magnet for generating a magnetic field. The cradle supports and aligns the medical device in a predetermined orientation. Medical device placed in the cradle exposes a magnetic sensitive switch to the magnetic field of the magnet that produces a change in state of the magnetic sensitive switch. Medical device further includes a switch, indicator, logic circuitry, delay circuit, and detect circuit for coupling a power source to electronic circuitry. In a first mode of operation the medical device can be turned on and then turned off. In a second mode of operation the medical device cannot be turned off after being turned on.

Abstract: An orthopedic implant having a three-axis accelerometer is disclosed. The three-axis accelerometer is used to detect micro-motion in the implant. The micro-motion can be due to loosening of the implant. The implant is configured to couple to the muscular-skeletal system. In one embodiment, the implant is configured to couple to bone. An impact force is imparted to the bone or implant. The impact force can be provided via a transducer coupled to the implant. In the example, the impact force is imparted along a single axis. The three-axis accelerometer measures the impact force along each axis. Resultant peaks of the quantitative measurement and the frequencies at which they occur are measured. The peaks and frequencies of the measurements correspond to micro-motion. Typically, the frequency of interest is less than 1 KHz to determine if micro-motion is occurring.

Abstract: A system is disclosed herein for providing a kinetic assessment and preparation of a prosthetic joint comprising one or more prosthetic components. The system comprises a prosthetic component including sensors and circuitry configured to measure load, position of load, and joint alignment. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from the sensors. The kinetic assessment measures joint alignment under loading that will be similar to that of a final joint installation. The kinetic assessment can use trial or permanent prosthetic components. Furthermore, adjustments can be made to the applied load magnitude, position of load, and joint alignment by various means to fine-tune an installation. The kinetic assessment increases both performance and reliability of the installed joint by reducing error that is introduced by elements that load or modify the joint dynamics not taken into account by prior assessment methods.

Abstract: A measurement device suitable to measure a force, pressure, or load applied by the muscular-skeletal system is disclosed. The measurement module includes a unitary circuit board that couples electronic circuitry to sensors. In one embodiment, the sensors are integrated in the unitary circuit board. Using more than one sensor allows the position of applied load by the muscular-skeletal system to be measured. In one embodiment, the sensors of a sensor array can be elastically compressible capacitors. A load plate can underlie the sensor array. Similarly, a load plate can overlie the load plate. Load plates are rigid structures for distributing a force, pressure, or load. The measurement device can include an articular surface for allowing movement of the muscular-skeletal system. A remote system can be in proximity to the measurement device. The remote system can receive, process, and display data from the measurement module in real-time.

Abstract: A prosthetic component suitable for long-term implantation is provided. The prosthetic component measures a parameter of the muscular-skeletal system is disclosed. The prosthetic component comprises a first structure having at least one support surface, a second structure having at least one feature configured to couple to bone, and at least one sensor. The prosthetic component is a housing for the at least one sensor and electronic circuitry. The electronic circuitry is hermetically sealed from an external environment. The at least one sensor couples to the support surface of the first structure. The support surface of the first structure is compliant. The first and second structure are coupled together housing the at least one sensor and electronic circuitry.

Abstract: A load balance and alignment system is provided to assess load forces on the vertebra in conjunction with overall spinal alignment. The system includes a spine instrument having an electronic assembly and a sensorized head. The sensorized head can be inserted between vertebra and report vertebral conditions such as force, pressure, orientation and edge loading. A GUI is therewith provided to show where the spine instrument is positioned relative to vertebral bodies as the instrument is placed in the inter-vertebral space. The system can report optimal prosthetic size and placement in view of the sensed load and location parameters including optional orientation, rotation and insertion angle along a determined insert trajectory.

Abstract: A system is disclosed herein for providing a kinetic assessment and preparation of a prosthetic joint comprising one or more prosthetic components. The system comprises a prosthetic component including sensors and circuitry configured to measure load, position of load, and joint alignment. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from the sensors. The kinetic assessment measures joint alignment under loading that will be similar to that of a final joint installation. The kinetic assessment can use trial or permanent prosthetic components. Furthermore, adjustments can be made to the applied load magnitude, position of load, and joint alignment by various means to fine-tune an installation. The kinetic assessment increases both performance and reliability of the installed joint by reducing error that is introduced by elements that load or modify the joint dynamics not taken into account by prior assessment methods.

Abstract: At least one embodiment is directed to a tracking system for the muscular-skeletal system. The tracking system can identify position and orientation. The tracking system can be attached to a device or integrated into a device. In one embodiment, the tracking system couples to a handheld tool. The handheld tool with the tracking system and one or more sensors can be used to generate tracking data of the tool location and trajectory while measuring parameters of the muscular-skeletal system at an identified location. The tracking system can be used in conjunction with a second tool to guide the second tool to the identified location of the first tool. The tracking system can guide the second tool along the same trajectory as the first tool. For example, the second tool can be used to install a prosthetic component at a predetermined location and a predetermined orientation. The tracking system can track hand movements of a surgeon holding the handheld tool within 1 millimeter over a path less than 5 meters.

Abstract: A system and method is disclosed herein for measuring bone slope or tilt of a prepared bone surface of the muscular-skeletal system. The system comprises a three-axis accelerometer for measuring position, rotation, and tilt. In one embodiment, the three-axis accelerometer can be housed in a prosthetic component that couples to a prepared bone surface. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from one or more sensors. A bone is placed in extension. The three-axis accelerometer is referenced to a bone landmark of the bone when the bone is in extension. The three-axis accelerometer is then coupled to the prepared bone surface with the bone in extension. The slope or tilt of the bone surface is measured. In the example, the slope or tilt of the bone surface corresponds to at least one surface of the prosthetic component attached thereto.

Abstract: An orthopedic implant having a three-axis accelerometer is disclosed. The three-axis accelerometer is used to detect micro-motion in the implant. The micro-motion can be due to loosening of the implant. The implant is configured to couple to the muscular-skeletal system. In one embodiment, the implant is configured to couple to bone. An impact force is imparted to the bone or implant. The impact force can be provided via a transducer coupled to the implant. In the example, the impact force is imparted along a single axis. The three-axis accelerometer measures the impact force along each axis. Resultant peaks of the quantitative measurement and the frequencies at which they occur are measured. The peaks and frequencies of the measurements correspond to micro-motion. Typically, the frequency of interest is less than 1 KHz to determine if micro-motion is occurring.

Abstract: A knee bone cut system and method is disclosed. The knee bone cut system supports cutting an anterior portion of a distal end of a femur. The system comprises a sensored insert, a femoral rotation guide, and a remote system to receive and display sensor data. The sensored insert provide data related to load magnitude, position of load, and leg position. The femoral rotation guide has moveable condyles to adjust condyle position in a rapid manner. A pinch mechanism and lock mechanism respectively move the condyles into contact with the sensored insert. Moreover, the femoral rotation guide can be loaded similar to a final installed insert over a range of motion. For example, the patella can be placed on the femoral rotation guide allowing the patella to load the sensored insert. The femoral insert guide includes guide holes that are used in conjunction with a bone cutting jig.

Abstract: A dual-mode closed-loop measurement system (100) for capturing a transit time, phase, or frequency of energy waves propagating through a medium (122) is disclosed. A first device comprises an inductor drive circuit (102), an inductor (104), a transducer (106), and a filter (110). A second circuit comprises an inductor (114) and a transducer (116). A parameter to be measured is applied to the medium (122). The medium (122) is coupled between the first device and the second device. The first device initiates the transmit inductor (104) to query via inductive coupling to a receive inductor (114) on the second device via a first path. The inductor (114) triggers a transducer (116) on the second device to emit an energy wave that is propagated in the medium (122) and detected by the first device. The transit time of energy waves is affected by the parameter by known relationship.

Abstract: A system and method is disclosed herein for measuring anterior-posterior slope of a bone to set a cutting jig coupled to the muscular-skeletal system. The system comprises a sensored module that can be placed within a prosthetic component to measure anterior-posterior slope. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from the sensors. A first bone and a second bone are placed in extension. A sensored module is referenced to a bone landmark of the first bone. The sensored module includes a three-axis accelerometer that is configured to measure position, tilt, and rotation. A bone cutting jig is coupled to the first bone. The sensored insert is coupled to the bone cutting jig. The accelerometer in the sensored insert is used to measure the anterior-posterior slope. The bone cutting jig is then adjusted to a predetermined anterior-posterior slope as measured by the sensored insert.

Abstract: A system and method is disclosed herein for measuring alignment of the muscular-skeletal system. The system comprises a sensored module that can be placed within a prosthetic component to measure load, position of load, and joint alignment. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from the sensors. Alignment relative to a mechanical axis is measured. In a two bone system with a joint therebetween the total alignment measured comprises offsets measured for each bone. The joint is placed in a predetermined flexion that supports measurement of the joint as it is moved. The joint pivots on a point that is along the mechanical axis. Points along the arc made by the joint rotating between a first and second point are measured. An arc maximum is determined. The arc maximum is then converted to varus or valgus offset relative to the mechanical axis.

Abstract: A prosthetic component suitable for long-term implantation is provided. The prosthetic component includes electronic circuitry and sensors to measure a parameter of the muscular-skeletal system. The prosthetic component comprises a first structure having at least one support surface, a second structure having at least one feature configured to couple to bone. The electronic circuitry and sensors are hermetically sealed within the prosthetic component. Sensors can be used to monitor synovial fluid in proximity to the joint to determine joint health. The prosthetic component can include a temperature sensor, a pH sensor, and an optical sensor. The temperature, pH, color, and turbidity of the synovial fluid can be correlated to a variety of joint conditions. Measurements over time can be analyzed for trends. The temperature, pH, color, and tubidity can be calibrated for the patient. The measurements are compared against this patient reference.

Abstract: A sensing insert device (100) is disclosed for measuring a parameter of the muscular-skeletal system. The sensing insert device (100) can be temporary or permanent. The sensing module (200) is a self-contained encapsulated measurement device having at least one contacting surface that couples to the muscular-skeletal system. The sensing module (200) comprises one or more sensing assemblages (2302), electronic circuitry (307), an antenna (2302), and communication circuitry (320). The sensing assemblages (2302) are between a top plate (1502) and a bottom plate (1504) in a sensing platform (121). The bottom plate (1504) is supported by a ledge (1708) on an interior surface of a sidewall (1716) of a housing (1706). A cap (1702) couples to top plate (1502). The sensing assemblage (2302) includes one of a piezo-resistive sensor, MEMS sensor, strain gauge, or mechanical sensor when a force, pressure, or load is applied to the top plate (1502).

Abstract: An orthopedic implant having an energy-harvesting device is disclosed. In one embodiment the orthopedic implant is a prosthetic component of a joint of the muscular-skeletal system. The orthopedic implant can include electronic circuitry, a power source, and one or more sensors for measuring a parameter of the muscular-skeletal system or a parameter of in proximity to the implant. The energy-harvesting device generates charge for powering the electronic circuitry using movement of the muscular-skeletal system. The energy-harvesting device comprises a piezo-electric element that converts changes in force into charge that is stored onto a storage device. The energy-harvesting device is coupled to the patella of a knee joint. Movement of the knee joint changes a force applied to the energy-harvesting device thereby generating charge that is coupled to circuitry in a prosthetic component of the knee joint.