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.

Abstract: A method of providing feedback to a user of an orthopedic alignment system, which displays: a portion of an orthopedic system; a parameter of the orthopedic system; a portion of an orthopedic insert in the display; and a parameter of the orthopedic insert. Where the method detects movement of the orthopedic system, and moves the displayed portion of the orthopedic system in response to the movement of the orthopedic system. Where the method additionally detects changes of the parameter of the orthopedic insert and of the parameter of the orthopedic system during movement of the orthopedic system, and displays the changes of the parameter of the orthopedic insert and the parameter of the orthopedic system.

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 measurement system for measuring a parameter of the muscular-skeletal system is disclosed. The measurement system comprises a capacitor, a signal generator, a digital counter, counter register, a digital clock, a digital timer, and a data register. The sensor of the measurement system is the capacitor. The measurement system generates a repeating signal having a measurement cycle that corresponds to the capacitance of the capacitor. The capacitor comprises more than one capacitor mechanically in series. Electrically, the capacitor comprises more than one capacitor in parallel. In one embodiment, the capacitor includes a dielectric layer comprising polyimide. A force, pressure, or load is applied to the capacitor that elastically compresses the device.

Abstract: At least one embodiment is directed to an insert for measuring a parameter of the muscular-skeletal system. The insert can be temporary or permanent. In one embodiment, the insert is prosthetic component for a single compartment of the knee. The insert comprises a support structure and a support structure respectively having an articular surface and a load bearing surface. The height of the insert is less than 10 millimeters. At least one internal cavity is formed when support structures are coupled together for housing electronic circuitry, sensors, and the power source. The internal cavity is isolated from the external environment and can be hermetically sealed. The exterior surfaces of the support structure and the support structure are sterilized.

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. Used intra-operatively, the sensing insert device (100) comprises an insert dock 202 and a sensing module 200. 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 sensors (303), electronic circuitry (307), and communication circuitry (320). The electronic circuitry (307) operatively couples to the one or more sensors (303) to measure the parameter. A transmitter (309) transmits parameter measurements. An induction coil (1404) is coupled electromagnetically to a wireless energy source (1402). The induction coil converts electromagnetic energy waves to a signal that powers the sensing module (200). The signal includes information or data.

Abstract: A prosthetic component suitable for trialing or long-term implantation is provided. The prosthetic component includes at least one sensor for measuring a parameter of the muscular-skeletal system or a biological parameter is disclosed. The prosthetic component comprises a conductive material. Electronic circuitry and sensors are housed within the prosthetic component. Data from the prosthetic component can be transmitted to a remote system. The prosthetic component can comprise steel, titanium, cobalt, an alloy, or other conductive material. At least a portion of the conductive material comprising the prosthetic component is coupled to ground to shield the sensor from parasitic coupling that can affect measurement accuracy. The prosthetic component can have an opening in the shield to allow sensing or transmission of data.

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: 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 (1802), electronic circuitry (307), an antenna (2302), and communication circuitry (320). The sensing assemblages (1802) 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 cap (1702) is adhesively coupled to the housing (1706). The adhesive is flexible allowing movement of the cap (1702) when a force, pressure, or load is applied thereto.

Abstract: A spine 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-vetebral space. The system can distract vertebrae to a first height and measure the load applied by the spine region. The GUI can indicate that the load is outside a predetermined range. The spine region can be distracted to a second height where the load is measured within the predetermined load range.

Abstract: A sensor system uses positive closed-loop feedback to provide energy waves into a medium. The medium can be coupled to the muscular-skeletal system or be part of the muscular-skeletal system. A sensor comprises one or more transducers, an edge detect circuit or a reflecting surface. A parameter is applied to the medium and the parameter affects the medium. A transducer receives an energy wave that has traversed the medium and generates an energy wave signal. The edge-detect receiver receives the energy wave signal signal from the transducer and generates a pulse upon sensing a leading edge corresponding to a wave front of the energy wave. The edge-detect receiver comprises a preamplifier, a differentiator, a digital pulse circuit, and a deblank circuit. The transit time, phase, or frequency is measured of the propagating energy waves and correlated to the parameter being measured.

Abstract: At least one embodiment is directed to an insert for measuring a parameter of the muscular-skeletal system. The insert can be temporary or permanent. In one embodiment, the insert is prosthetic component for a single compartment of the knee. The insert comprises a support structure and a support structure respectively having an articular surface and a load bearing surface. The height of the insert is less than 10 millimeters. At least one internal cavity is formed when support structures are coupled together for housing electronic circuitry, sensors, and the power source. The cavity is sterilized through a port. A membrane is between the port and the cavity. A sterilization gas permeates the membrane for sterilizing cavity. The membrane prevents ingress of solids and liquids to the cavity.

Abstract: A system for enabling 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 surgical spine measurement system comprises a first tool, a second tool, and a remote system. The first tool is a distractor having a plurality of load sensors for measuring load magnitude and position of load of a distracted region of the spine. The first tool and second tool also includes circuitry to measure a position and trajectory. The remote system receives data from the first tool and can display the parameter being measured and the position and trajectory of the first tool. A second tool holds a spine component. The remote system supports placement of the spine component by comparing the position and trajectory of the second tool to the path of the first tool. The remote system and second tool can provide visual, audible, or haptic feedback to support directing the second tool similarly to the first tool.

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.

Abstract: A system and method for measuring medial-lateral tilt of a bone is disclosed. The bone is coupled to a joint of the muscular-skeletal system. The method comprises coupling a three-axis accelerometer to a prepared bone surface of a bone. The three-axis accelerometer is configured to measure position, rotation, and tilt. The joint is rotated between two points. The rotation between the two points traverses an arc having a maximum therebetween. The joint pivots off of a surface to which the bone is coupled. In one embodiment, a pivot point and joint rotation relates to a mechanical axis of the joint and bone. The three-axis accelerometer measures data points along the arc as it is rotated between the two points. Multiple passes along the arc generates sufficient data points to determine the maximum. The position of the maximum is used to calculate the medial-lateral tilt of the bone.

Abstract: A bone cutting system is disclosed that supports one or more bone cuts that are aligned relative to a mechanical axis. The system comprises a first bone cutting jig, a second bone cutting jig, a sensored insert, a bone jig adapter shim, and a device having at least two reference surfaces. The sensored insert includes a three-axis accelerometer to measure position, rotation, and tilt and includes a plurality of sensors to measure a parameter of the muscular-skeletal system. The reference surface device can be an operating table having a first reference surface and a second reference surface that is perpendicular to the first reference surface for referencing the three-axis accelerometer. The bone jig adapter shim can include a tab that fits into a slot of the first or second bone cutting jigs. A remote system receives accelerometer data to calculate offset relative to a mechanical axis.

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 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: A system and method for adjusting a contact point of a joint is disclosed. The system comprises a prosthetic component having sensors therein and a remote system to receive and display sensor data. A plurality of sensors of the prosthetic component provide data related to load magnitude and position of load applied to a surface of the prosthetic component. The prosthetic component further includes one or sensors that provide position, rotation, and tilt data. Adjustment of the contact point of the prosthetic component can be performed by repositioning the prosthetic component relative to a bone to which it is coupled. For example, a prosthetic component can be pinned to the bone allowing rotation of the prosthetic component relative to the bone in-situ. A remote system receives sensor data from the prosthetic component allowing viewing of the load magnitude, position of load, and rotation of the prosthetic component.