Orthopedic insert measuring system for having a sterilized cavity

• US 8,926,530 B2
• Filed: 09/23/2011
• Issued: 01/06/2015
• Est. Priority Date: 09/23/2011
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: OrthoSensor, Inc (Stryker Corporation)
• Inventors: Stein, Marc, Miller, Andrew P., Addink, Jason, Chase, Andrew U.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US13/244,219
• Publication Number:
  US 20130079673A1
• Time in Patent Office: 1,201 Days
• Field of Search: 600/587, 606/90, 623/8
• US Class Current: 600/587
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2562/24 Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/4585 Evaluating the knee
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/3895 unicompartimental
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension

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.

Claims

1. An insert measurement system for measuring a parameter of the muscular-skeletal system including:

a first support structure having an articular surface;

a second support structure where the first and second support structure are coupled together and hermetically sealed

a load-bearing plate where the insert has at least one interior sterilized cavity housing electronic circuitry operatively coupled to at least one sensor, where the load-bearing plate lies between the articular surface and the at least one sensor, where the load-bearing plate is configured to transmit a portion of a load on the articular surface to the at least one sensor where the insert is placed within sterilized packaging such that the external surfaces and the at least one interior sterilized cavity remain sterile until used.

2. The insert measurement system of claim 1 where the at least one interior sterilized cavity is sterilized with a gas.

3. The insert measurement system of claim 2 where the at least one interior sterilized cavity includes a port that can be externally accessed to deliver a sterilization gas.

4. The insert measurement system of claim 3 where the port is normally closed.

5. The insert measurement system of claim 4 where a gas delivery system is inserted into the port to sterilize the interior of the insert and where the port closes after the gas delivery system is removed.

7. The insert measurement system of claim 1 where the at least one sensor includes three sensors interior to the insert coupled to the articular surface such that an applied load magnitude and a position of a load on the articular surface is measured.

8. The insert measurement system of claim 7 where the first and second support structures comprise polycarbonate.

6. An insert measurement system for measuring a parameter of the muscular-skeletal system comprising:

an articular surface and a load-bearing surface, where the insert has at least one interior sterilized cavity housing electronic circuitry operatively coupled to at least one sensor, where the at least one interior sterilized cavity is sterilized with a gas, where the at least one interior sterilized cavity includes a port that can be externally accessed to deliver a sterilization gas, where the port is configured to receive a gas delivery system which can be inserted into the port, where the port is configured to be closed after the gas delivery system is removed, where the port is configured to be closed during use of the insert measurement system, where an o-ring is in the port to seal the cavity from an external environment during use.

9. A method of preparing an intra-operative insert measurement system comprising:

inserting electronic circuitry into at least one cavity within an insert measurement system, where the insert measurement system includes;

a first support structure having an articular surface;

a second support structure where the first and second support structure are coupled together and hermetically sealed;

a load-bearing plate where the insert has at least one interior cavity housing electronic circuitry operatively coupled to at least one sensor, where the load-bearing plate lies between the articular surface and the at least one sensor, where the load-bearing plate is configured to transmit a portion of a load on the articular surface to the at least one sensor;

sterilizing exterior surface of the insert measurement system;

placing the insert measurement system within sterilized packaging such that the external surfaces remain sterile until used; and

disposing of the insert measurement system after surgery.

10. A method of using intra-operative muscular-skeletal parameter measurement system comprising:

opening a sterile package within a sterile field of an operating room, removing an insert from the sterile package, where the insert includes;

an articular surface; and

a load-bearing plate where the insert has at least one interior sterilized cavity housing electronic circuitry operatively coupled to at least one sensor, where the load-bearing plate lies between the articular surface and the at least one sensor, and where the load-bearing plate is configured to transmit a portion of a load on the articular surface to the at least one sensor;

inserting the insert in a joint of the muscular-skeletal system; and

measuring the parameter of the muscular-skeletal system; and

disposing of the insert after surgery.

11. An insert measurement system for measuring loading applied by the muscular-skeletal system comprising:

a first support structure having an articular surface;

a second support structure coupled to the first support structure where the first and second support structure form a housing having at least one cavity therein and where the housing is sealed from an external environment;

at least one load sensor coupled to the articular surface;

electronic circuitry coupled to the at least one load sensor where the at least one load sensor and the electronic circuitry are in the housing;

a load-bearing plate coupled between the articular surface and the at least one sensor where the load-bearing plate is configured to transmit a portion of a load on the articular surface to the at least one sensor, where the at least one sensor, electronic circuitry, and load-bearing plate are configured to be placed in the housing in a sterile environment, where the insert measurement system is configured to be placed within sterilized packaging such that the external surfaces of the first and second support structures remain sterile until used, and where the insert measuring system is configured to be disposed of after being used in surgery.

12. An insert measurement system for measuring a parameter of the muscular-skeletal system including:

an articular surface;

a port;

a load-bearing surface where the insert has at least one interior sterilized cavity housing electronic circuitry operatively coupled to at least one sensor, where the load-bearing surface is configured to transmit a portion of a load on the articular surface to the at least one sensor; and

an o-ring, where the o-ring is configured to fit in the port so as to seal the cavity from an external environment during use, where the port is configured to accept a gas for sterilization of the cavity.