Socket liner incorporating sensors to monitor amputee progress

• US 7,780,741 B2
• Filed: 01/14/2005
• Issued: 08/24/2010
• Est. Priority Date: 07/08/2002
• Status: Active Grant

• Current Assignee: Ossur hf
• Original Assignee: Ossur hf
• Inventors: Janusson, Hilmar Br., Karason, Gudjon G., Thorsteinsson, Freygardur
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US11/036,619
• Publication Number:
  US 20050125078A1
• Time in Patent Office: 2,048 Days
• Field of Search: 623 27- 36, 623/56, 602/62, 602/63
• US Class Current: 623/36
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1036 Measuring load distribution, e.g. podologic studies
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61F 2/76 Means for assembling, fitting or testing prostheses, e.g. for measuring or balancing, e.g. alignment means
• CPC Class Codes: A61F 2/7812 Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb stump
• CPC Class Codes: A61F 2002/7615 Measuring means for implanting artificial joints A61F2/4657
• CPC Class Codes: A61F 2002/7635 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/7655 for measuring fluid pressure
• CPC Class Codes: A61F 2002/766 for measuring moisture
• CPC Class Codes: A61F 2002/767 for measuring blood pressure
• CPC Class Codes: A61F 2002/7675 for measuring oxygen content
• CPC Class Codes: A61F 2002/802 Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump

Abstract

Disclosed is a device and method to aid in the monitoring of the health of an amputee'"'"'s limb. The device employs a socket preferably including a liner. The liner may be constructed of an inner layer and an outer layer. The inner layer is configured to hold a plurality of sensors able to monitor the physiological health of the enclosed limb. The inner layer further employs a transmission device able to receive data from the sensors and send such data to an end user; the end user being a computer, the amputee, or a doctor. Through receipt of such data, the end user is aided in monitoring the health of the limb.

Claims

1. A socket liner system for receiving a limb of an amputee, the system comprising:

a liner adapted to receive a residual limb of an amputee, the liner comprising a tubular body having a longitudinal axis that extends from a closed distal end of the liner to an open proximal end of the liner, wherein the liner is generally symmetrical about the longitudinal axis; and

a sensor provided in the liner that extends from one side of the liner tubular body to another side of the liner tubular body and passes over the closed distal end of the liner, the sensor configured to gather physiological data received therein over at least a portion of a day for subsequent monitoring of patient health.

2. The socket liner system of claim 1, further comprising a data gathering device configured to store the physiological data gathered by the sensor.

3. The socket liner system of claim 2, wherein the data gathering device is a computer.

4. The socket liner system of claim 1, wherein the sensor is a pressure sensor.

5. The socket liner system of claim 1, wherein the liner includes a groove for receiving the sensor.

6. The socket liner system of claim 1, wherein the sensor is a strip provided along an inner surface of the liner.

7. The socket liner system of claim 1, wherein the liner is adapted to receive a residual portion of an amputated leg.

8. A socket liner system for receiving a residual limb of an amputee, the system comprising:

a liner adapted to receive a residual limb of an amputee, the liner comprising a tubular body that extends generally symmetrically along a longitudinal axis from a closed distal end of the liner to an open proximal end of the liner, the liner including an inner layer having a pocket and an outer layer that provides an interface between the inner layer and a socket;

a sensor having a flexible portion and a rigid portion provided in the pocket of the liner inner layer, the sensor being configured to gather physiological data received therein over a desired length of time for subsequent monitoring of patient health; and

a memory configured to store the physiological data gathered by the sensor.

9. The socket liner system of claim 8, wherein the sensor is a strip provided in the liner inner layer.

10. The socket liner system of claim 8, further comprising a transmitter configured to transmit the physiological data to an end user to monitor the health of the residual limb.

11. The socket liner system of claim 8, wherein the sensor extends from one side of the liner tubular body to another side of the liner tubular body and passes over the closed distal end of the liner.

12. A socket liner system for receiving a limb of an amputee, the system comprising:

a liner adapted to receive a residual limb of an amputee, the liner comprising a tubular body that extends generally symmetrically along a longitudinal axis from a closed distal end of the liner to an open proximal end of the liner;

a sensor provided in the liner that extends from one side of the liner tubular body to another side of the liner tubular body and passes over the closed distal end of the liner, the sensor being configured to gather data regarding physiological characteristics of the limb over a desired length of time, wherein the sensor is in communication with a transmitter that is configured to send the gathered physiological characteristic data to a receiver to allow an end user to analyze the physiological characteristic data; and

a computer storing the physiological characteristic data gathered by the sensor.

13. The socket liner system of claim 12, wherein the sensor is a pressure sensor.

14. The socket liner system of claim 12, wherein the liner includes a groove for receiving the sensor.

15. The socket liner system of claim 12, wherein the liner includes a pocket for receiving the sensor.

16. The socket liner system of claim 12, wherein the sensor is a pressure sensor comprising a strip provided along an inner surface of the liner.

17. The socket liner system of claim 12, wherein the liner is made from two parts adhered together.

18. The socket liner system of claim 12, wherein the liner is adapted to receive a portion of an amputated leg.

19. A socket liner for receiving a residual limb of an amputee, the socket liner comprising:

an inner liner having an elongate sleeve with a cavity configured to receive a residual limb of an amputee, the inner liner having a tubular shape extending generally symmetrically about a longitudinal axis from a closed distal end of the inner liner to an open proximal end of the inner liner;

an outer liner positioned over the inner liner and having an exterior surface configured to receive a socket thereover, the outer liner having a tubular shape extending generally symmetrically about a longitudinal axis from a closed distal end of the outer liner to an open proximal end of the outer liner; and

a sensor configured to receive physiological data from the residual limb, the sensor positioned in a groove between the inner liner and the outer liner.

20. The socket liner of claim 19, wherein the sensor is an elongate strip configured to be wrapped around a portion of the inner liner.

21. The socket liner of claim 19, further comprising a plurality of sensors.

22. The socket liner of claim 19, further comprising an adhesive disposed between the inner liner and the outer liner.

23. The socket liner of claim 19, further comprising a transmitter configured to send data to a receiver to allow an end user to analyze physiological characteristics of the residual limb.

24. The socket liner of claim 19, wherein the sensor is selected from the group consisting of an oxygen sensor and a pressure sensor.

25. The socket liner of claim 19, wherein the sensor comprises an extending portion that extends outwardly from the open proximal end of the socket liner in a generally longitudinal direction.

26. A prosthetic system for a limb of an amputee, the system comprising:

a prosthetic socket;

a liner adapted to receive a residual limb of an amputee therein and to be removably positioned within the socket, the liner comprising a tubular body having a longitudinal axis that extends from a closed distal end of the liner to an open proximal end of the liner, the liner being generally symmetrical about the longitudinal axis;

a sensor provided in the liner, the sensor embedded within the liner wherein the sensor is disposed between an innermost surface and an outermost surface of a liner wall, and the sensor configured to gather physiological data of the residual limb over at least a portion of a day for subsequent monitoring of patient health;

a memory configured to store the physiological data gathered by the sensor; and

a prosthetic device operatively coupled to the socket.

27. The prosthetic system of claim 26, wherein the prosthetic device is a foot.

28. The prosthetic system of claim 26, wherein the prosthetic device is a leg.

29. The prosthetic system of claim 26, wherein the sensor is a strip sensor.

30. The prosthetic system of claim 26, wherein the sensor passes over the closed distal end of the tubular body.

31. The prosthetic system of claim 26, wherein the sensor comprises a flexible portion and a rigid portion.

32. The prosthetic system of claim 26, wherein the sensor extends out from the open proximal end of the liner and is folded back onto itself such that at least two sensors overlap one another.

33. A socket liner system for receiving a residual limb of an amputee, the system comprising:

a liner comprising a tubular body that extends generally symmetrically along a longitudinal axis from a closed distal end to an open proximal end, the liner comprising an inner layer and an outer layer, at least one of the inner and outer layers defining a channel; and

a sensor disposed in the channel such that the inner and outer layers are positionable adjacent each other at locations about the sensor, the sensor configured to gather physiological data from a residual limb received in the liner over a desired length of time for subsequent monitoring of patient health,

wherein the liner is adapted to be inserted in a prosthetic socket so that the outer layer provides an interface between the inner layer and the socket.

34. The socket liner system of claim 33, wherein the sensor is a strip sensor.

35. The socket liner system of claim 33, further comprising a transmitter adapted to transmit the physiological data to an end user to monitor the health of the residual limb.

36. The socket liner system of claim 33, further comprising a memory configured to store the physiological data gathered by the sensor.