Socket liner incorporating sensors to monitor amputee progress

• US 7,377,944 B2
• Filed: 07/08/2003
• Issued: 05/27/2008
• Est. Priority Date: 07/08/2002
• Status: Expired due to Term

• Current Assignee: Ossur hf
• Original Assignee: Ossur hf
• Inventors: Thorsteinsson, Freygardur, Janusson, Hilmar Br., Karason, Gudjon G.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/615,336
• Publication Number:
  US 20040059432A1
• Time in Patent Office: 1,785 Days
• Field of Search: 623/36, 623/37, 623 33- 34, 623/27, 623/57
• 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 for receiving a limb of an amputee, the socket liner comprising:

a liner in the shape of 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,

the liner has an inner and an outer layer, and

the outer layer serves to provide an interface between the inner layer and a socket; and

a physiological sensor configured to receive data from a limb regarding its physiological characteristics;

the sensor being positioned in a channel formed between the liner inner layer and the liner outer layer;

the sensor including an extending portion that extends outwardly from the open proximal end of the liner in a generally longitudinal direction;

the sensor being in communication with a transmitter; and

the transmitter configured to send data to a receiver to allow an end user to analyze the physiological characteristics of the limb.

2. The socket liner of claim 1, wherein the sensor wraps around the inner layer.

3. The socket liner of claim 1, wherein the extending portion of the sensor is more rigid than other portions of the sensor.

4. The socket liner of claim 1, further comprising a short sensor that is positioned in a second channel formed between the liner inner layer and the liner outer layer, wherein the short sensor does not extend from the open proximal end of the liner.

5. A socket liner for receiving an amputated limb of an amputee, the socket liner comprising:

an inner liner layer having an interior surface and an exterior surface and having a generally sock-like or sleeve-like configuration to receive, on the interior surface, the amputated limb;

an outer liner layer having an interior surface and an exterior surface and having a configuration generally matching that of the inner liner layer, the exterior surface of the outer liner layer receiving a socket; and

at least one sensor configured to receive data from the amputated limb regarding its physiological characteristics, the sensor disposed between the exterior surface of the inner liner layer and the interior surface of the outer liner layer, wherein the sensor is disposed in a channel formed between the exterior surface of the inner liner layer and the interior surface of the outer liner layer, and wherein the sensor includes an extending portion that extends outward from an inner liner layer opening in a generally longitudinal direction.

6. The socket liner of claim 5, wherein the sensor is positioned along a first side of the inner liner layer, around a bottom portion of the inner liner layer, and along a second side of the inner liner layer, the second side of the inner liner layer being opposite the first side of the inner liner layer.

8. The socket liner of claim 5 or 7, wherein the sensor is an oxygen sensor.

9. The socket liner of claim 5 or 7, wherein the sensor is a pressure sensor.

7. A socket liner for receiving an amputated limb of an amputee, the socket liner comprising:

a liner body having a generally sock-like or sleeve-like configuration and having an interior surface and an exterior surface;

the interior surface configured to receive the amputated limb;

the exterior surface having a configuration generally matching that of the interior surface and configured to receive a socket; and

a plurality of sensors configured to receive data from the amputated limb regarding its physiological characteristics, the sensor disposed between the exterior surface of the liner body and the interior surface of the liner body, and wherein the sensors comprise elongate strips positioned along a longitudinal axis of the liner body and disposed substantially around a circumference of the liner body.

10. The socket liner of claim 7, wherein the sensor wraps around a bottom portion of the interior surface of the liner body.

11. The socket liner of claim 7, wherein the sensor is molded into the liner body between the liner body interior surface and the liner body exterior surface.

12. The socket liner of claim 7, wherein the sensor includes an extending portion that extends outward form a liner body opening.

13. An apparatus comprising:

an inner liner configured to receive a residual limb of an amputee, wherein the inner liner has the shape of a tubular body with a longitudinal axis that extends from a closed distal end of the inner liner to an open proximal end of the inner liner, and wherein the inner liner is generally symmetrical about the longitudinal axis;

an outer liner positionable over the inner liner to define a liner body, the outer liner having an exterior surface configured to receive a socket thereover, such that the outer liner forms an interface between the inner liner and the socket; and

a plurality of sensors configured to receive physiological data from the residual limb, the sensors comprising elongate strips positioned along a longitudinal axis of the liner body and disposed substantially around a circumference of the liner body.

14. The apparatus of claim 13, wherein the sensor is an elongate strip configured to be wrapped around a portion of the inner liner.

15. The apparatus of claim 13, further comprising a plurality of sensors configured to receive physiological data from the residual limb.

16. The apparatus of claim 13, further comprising an adhesive disposed between the inner liner and the outer liner.

17. The apparatus of claim 13, further comprising a transmitter configured to send data to a receiver to allow an end user to analyze physiological characteristics of the residual limb.

18. The apparatus of claim 13, wherein the sensor is selected from the group consisting of an oxygen sensor and a pressure sensor.

19. An apparatus for monitoring amputee progress, comprising:

a liner having an inner layer and an outer layer, wherein the liner inner layer is configured to receive a residual limb of an amputee, the outer layer being coupleable with a socket;

a plurality of sensors, each sensor being formed as an elongate strip and being able to sense physiological characteristics of the residual limb along substantially its entire length, the sensors being disposed between the inner liner layer and outer liner layer such that the two layers are substantially laminated to each other, the elongate sensors being disposed longitudinally along the body of the liner substantially about the circumference of the liner; and

a transmitter configured to send data to a receiver to allow an end user to analyze the physiological characteristics of the residual limb.

20. The apparatus of claim 19, wherein the sensors are in a channel formed in one layer such that the other layer is laminated to that layer except where the sensor is located.

21. The apparatus of claim 19, wherein the sensors are integrated into a wall of the liner.

22. The apparatus of claim 19, wherein at least one sensor extends along a closed distal end of the liner to correspond to the distal end of the residual limb.

23. The apparatus of claim 19, wherein at least one of the sensors is selected from the group consisting of an oxygen sensor and a pressure sensor.

24. The apparatus of claim 19, further comprising a supplementary physiological sensor incorporated into the socket.

25. The apparatus of claim 19, wherein at lease one of the elongate strips has a portion folded back onto itself.