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 electronic circuitry and sensors are hermetically sealed within the prosthetic component. The sensor couples to the support surface of the first structure. The first and second structure are coupled together housing the at least one sensor. The first and second structures comprises steel, titanium, cobalt or an alloy thereof. At least one of the first or second structures is coupled to ground to shield the sensor from parasitic coupling. The at least one sensor can be a pressure sensor for measuring load and position of load.

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 electronic circuitry and sensors are hermetically sealed within the prosthetic component. The 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. In one embodiment, the first and second structure are welded together forming the hermetic seal that isolates the at least one sensor from an external environment. The at least one sensor can be a pressure sensor for measuring load and position of load.

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, and at least one sensor. The electronic circuitry and sensors are hermetically sealed within the prosthetic component. One or more sensors can be used to monitor synovial fluid in proximity to the joint to determine joint health. The prosthetic component includes a transmissive region. One or more optical sensors are mounted in proximity to the transmissive region. Periodic measurements of the synovial fluid are measured through the transmissive region. The measurements can include color and turbidity of the synovial fluid. The color and turbidity data can be compared against known data to determine joint status.

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 or a pH sensor. The temperature or pH of the synovial fluid can be correlated to a variety of joint conditions. Measurements over time can be analyzed for trends. The temperature or pH can be calibrated for the patient. For example, calibration can be for temperature or pH of a patient healthy joint. The measurements are compared against this patient reference.

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 electronic circuitry and sensors are hermetically sealed within the prosthetic component. The sensor couples to the support surface of the first structure. The first and second structure are coupled together housing the at least one sensor. In one embodiment, the first and second structure are welded together forming the hermetic seal that isolates the at least one sensor from an external environment. The at least one sensor can be a pressure sensor for measuring load and position of load.

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: 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: 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: 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. The capacitor is shielded from parasitic coupling and parasitic capacitance.

Abstract: A measurement system for capturing a transit time, phase, or frequency of energy waves propagating through a propagation medium is disclosed. The measurement system comprises a compressible waveguide (403), ultrasonic transducers (405, 406), and circuitry to sustain energy wave propagation in the waveguide (403). The circuitry includes a propagation tuned oscillator (404), a digital counter (409), a pulse generator (410), a phase detector (414), a counter (420), a digital timer (422), and a data register (424). The measurement system employs a continuous mode (CM), pulse mode, or pulse-echo mode of operation to evaluate propagation characteristics of continuous ultrasonic waves in the waveguide by way of closed-loop feedback to determine levels of applied forces on the waveguide.

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 method for determining position and alignment is provided. The method includes monitoring a first and second sequence of ultrasonic signals transmitted from the first device to a second device, estimating a location of the first device from Time of Flight measurements of the ultrasonic signals at respective microphones on the second device, calculating a set of phase differences, weighting a difference of an expected location and estimated location of the first device with the set of phase differences to produce a relative displacement, and reporting a position of the first device based on the relative displacement.

Abstract: A low-cost and compact electronic device toolset is provided for orthopedic assisted navigation. The toolset comprises wireless sensorized devices that communicate directly with one another. A computer workstation is an optional component for further visualization. The sensorized devices are constructed with low-cost transducers and are self-powered. The toolset is disposable and incurs less hospital maintenance and overhead. As one example, the toolset reports anatomical alignment during a surgical workflow procedure. Other embodiments are disclosed.

Abstract: One or more disposable devices suitable for use in a surgical field of an operating room are disclosed. One device comprises a sensor (101) communicatively coupled to the wand (102) to register points of interest on a first or second bone of the muscular-skeletal system and transmits location data related to the points of interest to the sensor (101) to assess orthopedic alignment with the points of interest. A display (150) having a GUI (152) are coupled to the devices for providing device and surgical information in real-time. A communication device (104) includes display (150) and a digital signal processor (154). A transducer (142) receives vocal commands (140) for generating an action (146) that produces an operative change in the devices or display (150). The DSP (154) includes voice recognition software (144) for identifying words or phrases to produce an action (146) that are received by the transducer (142).

Abstract: A disposable tool suitable for use in orthopedic alignment comprises a sensor (101) communicatively coupled to the wand (102) to register points of interest on a first and second bone and transmit location data related to the points of interest to the sensor (101) to assess orthopedic alignment with the points of interest. A display via a wireless connection to the tool reports and visually displays alignment information in real-time. The wand (102) and the sensor (101) each have at least two ultrasonic transducers. The wand (102) has a housing fits in a hand and includes a tip (134) for identifying and registering a location. The wand (101) can be attached to a mount in a predetermined position within the surgical field during a portion of the alignment procedure. Sensor (101) and wand (102) remain within the surgical field throughout the surgery and are disposed of after use in surgery.

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, electronic circuitry (307), an antenna (2302), and communication circuitry (320). The sensing assemblages are between a top plate (1502) and a bottom plate (1504) in a sensing platform (121). The sensing assemblages measure the parameter and comprise a load disc (2004) and a piezo-resistive sensor (2002). Three sensing assemblages are coupled at predetermined positions to the top plate (1502). The sensing module (200) can measure a location where the parameter is applied to the top plate (1502).

Abstract: A measurement system for capturing a transit time, phase, or frequency of energy waves propagating through a propagation medium is disclosed. The measurement system comprises two different closed-loop feedback paths. The first path includes a transducer driver (726), a transducer (704), a propagation structure (702), a transducer (706), and a zero-crossing receiver (740). The transducer driver (726) efficiently drives the transducer (704) and comprises a digital driver (106), a level shifter (112), and a matching network (114). A second path includes a transducer driver (1126), a transducer (1104), a propagation medium (1102), a reflecting surface (1106), and an edge-detect receiver (1140). Energy waves in the propagating medium (1102) are reflected at least once. The edge-detect receiver (1140) detects a wave front of an energy wave. Each positive closed-loop path maintains the emission, propagation, and detection of energy waves in the propagation medium.

Abstract: A measurement system for capturing a transit time, phase, or frequency of energy waves propagating through a propagation medium is disclosed. The measurement system comprises a sensing module (200) and an insert dock (202). The sensing module (200) includes a load sensing platform (121), an accelerometer (122), and sensing assemblies (123). In one embodiment, a force or load applied by the muscular-skeletal system is measured. The force or load is applied to the sensing assembly (123). The accelerometer (122) generates motion data. The motion data includes acceleration data. The force or load measured by sensing assembly (123) in combination with the motion data captured by the accelerometer (122) is used to calculate a total force or load. A second accelerometer can be used to provide reference position information. The sensing assemblies (123) comprise a transducer (304), an elastic or compressible propagation structure (305), and a second transducer (314).

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 insert dock (202) is a passive component made for different prosthetic component manufacturers as well as for different size prosthetic components. The sensing module (200) fits in an opening or cavity of the insert dock (202). The intra-operative insert device is substantially equal in dimension to an implanted final insert. The sensing insert device (100) is also a permanent prosthetic component. The sensing module (200) residing within the sensing insert device and coupling to a bearing surface of the insert.

Abstract: At least one embodiment is directed to a sensor for measuring a parameter. A signal path of the system comprises an amplifier (612), a sensor element, and an amplifier (620). The sensor element comprises a transducer (4), a waveguide (5), and a transducer (30). A parameter such as force or pressure applied to the sensor element can change the length of waveguide (5). A pulsed energy wave is emitted by the transducer (4) into the waveguide (5) at a first location. The transducer (30) is responsive pulsed energy waves at a second location of the waveguide (5). The transit time of each pulsed energy wave is measured. The transit time corresponds to the pressure or force applied to the sensor element.