Miniature implanted orthopedic sensors

Surgery – Diagnostic testing

Reexamination Certificate

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Details

C600S373000, C600S377000, C128S899000

Reexamination Certificate

active

06447448

ABSTRACT:

TECHNICAL FIELD OF THE INVENTION
This invention is related to a biomedical device, and more particularly to a spherical-shaped biomedical integrated circuit for diagnostics; electronic patient monitoring; prosthetics; computerized data processing and tracking of device performance; and other invasive biomedical applications involving orthopedic implant prostheses (artificial joints, tendons, bones and bone segments), and internal and external orthopedic fixation devices.
This application is related to the following commonly assigned co-pending U.S. Patent applications: Ser. No. 09/448,642 entitled “Miniature Spherical-Shaped Semiconductor With Transducer;” Ser. No. 09/448,641 entitled “Intraluminal Monitoring System;” Ser. No. 09/448,781 entitled “Spherical-Shaped Biomedical IC;” Ser. No. 09/448,678 entitled “Method of and System for Identifying Medical Products;” Ser. No. 09/448,638 entitled “Internal Thermometer;” and Ser. No. 09/448,644 entitled “Monitor for Interventional Procedures;” each of which were filed on Nov. 24, 1999, and co-pending U.S. patent application Ser. No. 09/475,819 entitled “Injectable Thermal Balls For Tumor Ablation,” filed of even date with this application, and each of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION
Invasive and non-invasive orthopedic medical devices are known in the art, some examples of which are described in the BIOMEDICAL ENGINEERING HANDBOOK, Bronzino, CRC Press (1995). Instrumented orthopedic devices to assess performance in situ are also known in the art. However, these devices are limited in performance assessment by the absence of reliable applied sensors to gauge orthopedic device function in situ. In those cases where sensors have been applied to the device, the flat planar surface technology that is conventionally used in the fabrication of these semiconductor integrated circuits further limits the operability and versatility of the devices.
SUMMARY OF THE INVENTION
The invention disclosed and claimed herein comprises, in one aspect thereof, an implantable integrated circuit for use with implantation in an organic medium associated with an organic organism. The integrated circuit includes a substantially spherical shaped substrate. At least one transducer is disposed on the substrate for interacting with the organic medium in which the implantable IC is implanted. The transducer operates in accordance with associated operating parameters. Communications circuitry is associated with the substrate for allowing external interface to the at least one transducer for receiving information therefrom.
In another aspect of the invention, the substantially spherical integrated circuit is implanted in internal and external orthopedic fixation devices.
In a further aspect of the invention, the substantially spherical integrated circuit is implanted in orthopedic prostheses which include artificial joints, and artificial intervertebral disks.
In still another aspect of the invention, the substantially spherical integrated circuit is implanted in an orthopedic medium such as tendons, ligaments, and bone. Transponders which function as position sensors can be temporarily affixed to bone intraoperatively to allow correct positioning of artificial limbs or joints (angle of inclination). Current methodology for alignment of hip joints requires manual and visual means leading to malalignment, a major cause of morbidity in patients undergoing this procedure. Implantable prosthetic devices containing multiple position sensor balls can detect the angle of movement of a prosthetic device. Following artificial knee and shoulder replacement, increasing ranges of movement are required to rehabilitate the joints. Position sensor balls can be programmed to elicit a signal once the goal range of motion is achieved Every few days the goal can be increased to facilitate the recovery period postoperatively. Alternatively, following artificial hip replacement, the range of motion of the hip joint should initially be limited to enhance the long term stability of the prosthetic device. In this instance, a warning signal will be elicited if the angle of motion is exceeded. Each week the limiting range of motion of the hip is increased, again to facilitate the recovery period postoperatively. In further embodiments, transponders determining strain and tensile strength can be implanted in ligaments. For example, transponders implanted in the anterior cruciate ligament can determine the tensile strength of the ligament allowing the physician when to safely instruct the patient to return to progressive activities requiring increasing demands upon the ligament. Current methodology does not apply internal devices to determine proper alignment intraoperatively and monitoring of rehabilitation postoperatively.
In another application, the ball can function as an actuator used to stimulate excitable tissue. The semiconductor ball can function as a TENS (Transcutaneous Electrical Nerve Stimulator) unit to treat chronic pain syndromes. The unit can also be used to stimulate both nerve and muscles in paralyzed or injured limbs to help prevent the development of atrophy or as a means to reduce the inflammatory response. Multiple balls which function as both receivers of electrical signal and also as transmitters of signal may be useful in robotic applications. These sensors and actuators could function as a bridge between an amputated limb and a moveable prosthetic “hand” or provide for an entirely functional robotic prosthetic limb


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