CA2488733C

CA2488733C - Socket liner incorporating sensors to monitor amputee progress

Info

Publication number: CA2488733C
Application number: CA2488733A
Authority: CA
Inventors: Hilmar Br. Janusson; Freygardur Thorsteinsson; Gudjon G. Karason
Original assignee: Ossur hf
Current assignee: Ossur hf
Priority date: 2002-07-08
Filing date: 2003-07-08
Publication date: 2013-09-17
Anticipated expiration: 2023-07-08
Also published as: EP1539028A2; AU2003251983A8; JP4544994B2; CA2488733A1; US20050125078A1; US7780741B2; WO2004004601A2; US20040059432A1; WO2004004601A3; US7377944B2; CN100438828C; JP2005532852A; AU2003251983A1; CN1655717A

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.

Description

SOCKET LINER INCORPORATING
SENSORS TO MONITOR AMPUTEE PROGRESS
Background of the Invention Field of the Invention The field relates generally to a device and method for monitoring of the health of a person's limbs.
More specifically, some embodiments relate to the analysis of data affecting the health of an amputee's limb.
Some embodiments are targeted towards monitoring a limb through the use of a socket liner.
Description of the Related Art Through the use of ever improving technology, amputees are finding more ways to function through the use of prosthetic devices. Often an amputee uses a socket placed over a limb which is thereby attached to the prosthetic device. The prosthesis may function as a leg, arm, foot, or hand for the amputee.
Use of sockets, however, may cause irritation, volumetric shrinkage and other adverse reactions to the user. Often liners, socks, sleeves, and other limb coverings are used to aid in the prevention of injury to the limb while the socket is in place. Damage to the limb may still occur despite the protection that a liner may provide.
There exists a need for new devices and methods that provide additional functionality to an amputee who uses a socket.
Summary of the Invention Briefly stated, embodiments of the present invention provide a device and method that allows an amputee or a person such as a doctor or prosthetist to monitor various characteristics of a limb. More specifically, the monitoring occurs when the limb is covered by a garment such as a socket or other item having a receiving portion adapted to receive the limb. Preferably, the limb is covered with a socket liner.
Optionally the liner may be of a single or multiple layer construction. The liner is configured to hold sensors such as physiological sensors adapted to receive data from the limb throughout the day. The sensors may be constructed to receive a variety of physiological traits from the limb.
Preferably, the liner further comprises a transmitter configured to receive data from the sensors and transmit such data to a computer, a user, a doctor or a prosthetist. The receiver of the data is thereby aided in monitoring the health of the enclosed limb.
Accordingly, in one embodiment, a socket is provided for receiving a limb of an amputee. The socket comprises a liner adapted to receive a limb of an amputee, and one or more sensors provided in the liner, the sensors being adapted to monitor physiological data received therein. In one embodiment the liner includes a plurality of grooves for receiving the sensors. The sensors in one embodiment are strips provided along a surface of the liner. In other embodiments, the sensors may be composed of various shapes and sizes. For example, ring-like sensors could be placed around or within the liner. Also, smaller sensors could -1-.

be placed at discreet locations along the length of the liner. These smaller sensors may be composed of circular or other geometric shapes. In one embodiment the liner is made from two pads adhered together.
One embodiment of a socket liner includes a liner and one or more sensors provided in the liner adapted to monitor data. One liner includes an inner layer, an outer layer, and a sensor in a channel used to monitor physiological characteristics of a limb. Another liner holds a physiological sensor for receiving data from a limb and transmitter for sending the data to a receiver. Another embodiment discloses a garment with a receiving portion to hold a plurality of sensors wherein the garment is configured to transmit received data to an end user. Also provided is a method of monitoring the physiological characteristics of a limb by using data accumulated from a liner having goe physiological sensor located therein.
In accordance with an aspect of the present invention there is provided a socket liner for receiving a limb of an amputee, comprising: a liner adapted to receive a limb of an amputee, the liner extending from an open top end to a bottom end; and one or more sensors embedded in the liner between a innermost surface of the liner and an outermost surface of the liner, the one or more sensors being adapted to monitor data received therein.
In accordance with a further aspect of the present invention there is provided a liner for receiving a limb of an amputee comprising: an inner layer and an outer layer; at least one sensor disposed between the inner layer and the outer layer, wherein the at least one sensor is used to monitor physiological characteristics of the limb; and the outer layer configured to cover the inner layer.
In accordance with a further aspect of the present invention there is provided a socket liner for receiving a limb of an amputee comprising: an inner layer and an outer layer, the inner and outer layers attached to each other; a physiological sensor disposed between the inner layer and the outer layer so that the sensor is covered by the inner and outer layers, the sensor configured to receive data from a limb regarding its physiological characteristics; the sensor being in communication with a transmitter; the transmitter configured to send data to a receiver to allow an end user to analyze the physiological characteristics of the limb.
In accordance with a further aspect of the present invention there is provided a garment for receiving a limb of an amputee comprising: a receiving portion adapted to receive the limb and comprising an inner layer and an outer layer to hold a plurality of sensors between the inner layer and the outer layer; the sensors adapted to receive physiological data from the limb; the garment configured to transmit the physiological data to an end user to monitor the health of the limb.
In accordance with a further aspect of the present invention there is provided a method for monitoring the physiological characteristics of a limb comprising: providing a liner having at least one physiological sensor embedded in the liner between an innermost surface of the liner and an outermost surface of the liner, and monitoring physiological characteristics of the limb using data accumulated from the sensor.

In accordance with a further aspect of the present invention there is provided a method for monitoring the physiological characteristics of a limb comprising: providing a liner having at least one physiological sensor embedded in the liner between an innermost surface of the liner and an outermost surface of the liner, and monitoring physiological characteristics of the limb using data accumulated from the sensor.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
2a In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
2b In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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.
In accordance with a further aspect of the present invention there is provided 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 2c prosthetic socket so that the outer layer provides an interface between the inner layer and the socket.
Brief Summary of the Drawings Figure 1 depicts an assembled embodiment of a two-layered socket liner.
Figure 2 shows an inner liner with a pressure sensor wrapping over its bottom layer.
Figure 3 depicts an alternative view of the inner liner of Figure 2.
Figure 4 shows an embodiment of an inner layer of a socket liner having an oxygen sensor and pressure sensors.
Figure 5 depicts an altemative view of the socket liner of Figure 4.
Figure 6 is a side view of a two-layered liner.
Figure 6a is a top end view of the liner of Figure 6.
Figure 7 is a side view of an inner layer with sensors.
Figure 8 is a cross-sectional view of a two-layered liner.
Figure 91s an isometric view of an inner layer with pressure sensors.
Detailed Description of the Preferred Embodiments Preferred embodiments of the present invention are directed to developing an interface for amputees, where physical data for a limb can be gathered over a period of time in normal action. In one embodiment a socket is used as an interface between the limb and a prosthesis.
Amputees may use liners to provide suspension and comfort inside of the socket. A liner may be made of silicone or other material and may provide a locking mechanism with the socket. Locking liners incorporate a pin and are relied upon for suspension of the socket. Non-locking liners or cushion liners are generally used for comfort purposes and use belts or other mechanisms to provide suspension of the socket. The term liner is meant to be construed as a broad term and may encompass a sock, a sleeve, an insert or other coverings placed over an amputee's limb. At the same time, liner is meant to be used in its plain and ordinary meaning. In one embodiment, described further below, sensors are incorporated into the socket liner that is placed between the limb and the socket. In alternative embodiments, sensors may be incorporated into a socket sock or in the socket itself. Typically socks provide cushioning for the limb and add volume to the limb that is lost throughout the day.
2d Preferably, sensors are placed in a silicone or other polymer material (e.g., thermoplastic elastomers or polyurethane) that comprise the socket liner. Sensors may include, but are not limited to:
= Oxygen sensors for the measurement and mapping of peripheral oxygen, such as by means of an array of high sensitivity Spo2 sensors;
= Pressure sensors detecting the fit of the liner and/or socket over the limb;
= Temperature sensors;
= Sensors to measure blood pressure;
= Humidity sensors;
= Sensors to measure glucose;
= Sensors to measure limb movement within the liner and/or socket throughout the gait;
= Sensors to measure volume fluctuation of the limb throughout the day;
= Sensors to measure body fat;
= Activity monitoring sensors, i.e. how long the prosthesis is worn from day to day and whether there are high periods of activity.
= Sensors to measure the shear forces exerted on a limb by the liner and/or socket.
It will be appreciated that other sensors may be used in the liner for different applications and for other diagnostic or physiological measurements.
Data obtained by the sensors can be sent to a remote location to a rehabilitation doctor and/or a CPO (Certified Prosthetist/Orthotist) using telecommunications equipment incorporated into or with the liner.
This approach assists amputees to integrate into the society and maximize the comfort and use of their prosthesis. Another objective is to gather medical information about amputees in a statistical way, thus giving possibilities for better treatment. The sensors may be held in place within the liner through the use of grooves, channels, or pockets. The pockets may have opened or closed ends.
Alternatively, a combination of grooves, channels, and pockets may exist. Further, the sensors may extend over the liner. The sensors may be made of rigid, soft, or a combination of rigid and soft materials.
Two ways that sensors can be incorporated into a socket liner are integrated sensors, and sensors placed in-between layers of the socket liner. Sensors, however may be placed into socks, socket inserts, the socket itself, as well as other layers of material that may be incorporated into a device placed over an amputee's limb.
Figure 1 illustrates one embodiment of a socket liner incorporating physiological sensors, more preferably pressure sensors 14, 16 and oxygen sensors 12. The term "physiological sensor" is meant to define a broad term as well as its ordinary meaning. Physiological sensors may be used to measure peripheral oxygen, temperature, humidity, body fat, blood gasses, blood pressure, blood glucose levels, and other related data such as described above. Physiological pressure sensors 14, 16 may be used to monitor the pressure exerted by the limb onto the liner which can be used as a measure of a patient's health. The be placed at discreet locations along the length of the liner. These smaller sensors may be composed of circular or other geometric shapes. In one embodiment the liner is made from two pads adhered together.
One embodiment of a socket liner includes a liner and one or more sensors provided in the liner adapted to monitor data. One liner includes an inner layer, an outer layer, and a sensor in a channel used to monitor physiological characteristics of a limb. Another liner holds a physiological sensor for receiving data from a limb and transmitter for sending the data to a receiver. Another embodiment discloses a garment with a receiving portion to hold a plurality of sensors wherein the garment is configured to transmit received data to an end user. Also provided is a method of monitoring the physiological characteristics of a limb by using data accumulated from a liner having goe physiological sensor located therein.
In accordance with an aspect of the present invention there is provided a socket liner for receiving a limb of an amputee, comprising: a liner adapted to receive a limb of an amputee, the liner extending from an open top end to a bottom end; and one or more sensors embedded in the liner between a innermost surface of the liner and an outermost surface of the liner, the one or more sensors being adapted to monitor data received therein regarding the health of said amputee's limb.
In accordance with a further aspect of the present invention there is provided a liner for receiving a limb of an amputee comprising: an inner layer and an outer layer; at least one sensor disposed between the inner layer and the outer layer, wherein the at least one sensor is used to monitor physiological characteristics of the limb; and the outer layer configured to cover the inner layer.
In accordance with a further aspect of the present invention there is provided a socket liner for receiving a limb of an amputee comprising: an inner layer and an outer layer, the inner and outer layers attached to each other; a physiological sensor disposed between the inner layer and the outer layer so that the sensor is covered by the inner and outer layers, the sensor configured to receive data from a limb regarding its physiological characteristics; the sensor being in communication with a transmitter; the transmitter configured to send data to a receiver to allow an end user to analyze the physiological characteristics of the limb.
In accordance with a further aspect of the present invention there is provided a garment for receiving a limb of an amputee comprising: a receiving portion adapted to receive the limb and comprising an inner layer and an outer layer to hold a plurality of sensors between the inner layer and the outer layer; the sensors adapted to receive physiological data from the limb; the garment configured to transmit the physiological data to an end user to monitor the health of the limb.

Claims

WHAT IS CLAIMED IS:

1. A socket liner for receiving a limb of an amputee, comprising:
a liner adapted to receive a limb of an amputee, the liner extending from an open top end to a bottom end; and one or more sensors embedded in the liner between a innermost surface of the liner and an outermost surface of the liner, the one or more sensors being adapted to monitor data received therein regarding the health of said amputee's limb.

2. The socket liner of Claim 1, wherein the one or more sensors are pressure sensors.

3. The socket liner of Claim 1, wherein the one or more sensors are oxygen sensors.

4. The socket liner of Claim 1, wherein the one or more sensors comprise both pressure sensors and oxygen sensors.

5. The socket liner of Claim 1, wherein the liner includes a plurality of grooves for receiving the one or more sensors therein.

6. The socket liner of Claim 1, wherein the liner includes a plurality of pockets for receiving the one or more sensors therein.

7. The socket liner of Claim 1, wherein the one or more sensors are strips.

8. The socket liner of Claim 1, wherein the liner comprises an inner layer that defines said innermost surface of the liner and an outer layer that defines said outermost layer of the liner, the inner and outer layers attached to each other, the one or more sensors disposed between the inner layer and the outer layer.

9. The socket liner of Claim 7, wherein at least one of the one or more sensors wraps around the bottom end of the liner.

10. A liner for receiving a limb of an amputee comprising:
an inner layer and an outer layer;
at least one sensor disposed between the inner layer and the outer layer, wherein the at least one sensor is used to monitor physiological characteristics of the limb;
and the outer layer configured to cover the inner layer.

11. The liner of Claim 10 wherein one or both of the inner layer and outer layer comprises at least one channel sized to receive the at least one sensor therein.

12. The liner of Claim 10 wherein the at least one sensor is an oxygen sensor.

13. The liner of Claim 10 wherein the at least one sensor is a pressure sensor.

14. The liner of Claim 10 wherein the at least one sensor is a strip.

15. The liner of Claim 14, wherein the at least one sensor wraps around a bottom of the inner layer.

16. A socket liner for receiving a limb of an amputee comprising:
an inner layer and an outer layer, the inner and outer layers attached to each other;
a physiological sensor disposed between the inner layer and the outer layer so that the sensor is covered by the inner and outer layers, the sensor configured to receive data from a limb regarding its physiological characteristics;
the sensor being in communication with a transmitter;
the transmitter configured to send data to a receiver to allow an end user to analyze the physiological characteristics of the limb.

17. The socket liner of Claim 16 wherein:
the inner layer is configured to hold the sensor; and the outer layer serves to provide an interface between the inner layer and the socket.

18. The socket liner of Claim 17, wherein the sensor wraps around a bottom of the inner layer.

19. A garment for receiving a limb of an amputee comprising:
a receiving portion adapted to receive the limb and comprising an inner layer and an outer layer to hold a plurality of sensors between the inner layer and the outer layer;
the sensors adapted to receive physiological data from the limb;
the garment configured to transmit the physiological data to an end user to monitor the health of the limb.

20. A method for monitoring the physiological characteristics of a limb comprising:
providing a liner having at least one physiological sensor embedded in the liner between an innermost surface of the liner and an outermost surface of the liner; and monitoring physiological characteristics of the limb using data accumulated from the sensor.

21. The socket liner of Claim 7, wherein at least one of the one or more sensors extends over an edge of the liner.

22. The liner of Claim 14, wherein the at least one sensor extends over an edge of the liner.

23. The socket liner of Claim 7, wherein at least one of the one or more sensors has a rigid portion and a flexible portion.

24. The liner of Claim 14, wherein the at least one sensor has a rigid portion and a flexible portion.

25. The method of Claim 20, wherein the liner comprises an inner layer and an outer layer, the sensor disposed between the inner layer and outer layer so that the sensor does not directly contact the limb.

26. 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.

27. The socket liner of claim 26, wherein the sensor wraps around the inner layer.

28. The socket liner of claim 26, wherein the extending portion of the sensor is more rigid than other portions of the sensor.

29. The socket liner of claim 26, 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.

30. 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.

31. The socket liner of claim 30, 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.

32. 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 characteristic, 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

33 The socket liner of claim 30 or 32, wherein the sensor is an oxygen sensor.

34 The socket liner of claim 30 or 32, wherein the sensor is a pressure sensor.

35. The socket liner of claim 32, wherein the sensor wraps around a bottom portion of the interior surface of the liner body.

36. The socket liner of claim 32, wherein the sensor is molded into the liner body between the liner body interior surface and the liner body exterior surface

37. The socket liner of claim 32, wherein the sensor includes an extending portion that extends outward form a liner body opening.

38. 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.

39. The apparatus of claim 38, wherein the sensor is an elongate strip configured to be wrapped around a portion of the inner liner.

40. The apparatus of claim 38, further comprising a plurality of sensors configured to receive physiological data from the residual limb.

41. The apparatus of claim 38, further comprising an adhesive disposed between the inner liner and the outer liner.

42. The apparatus of claim 38, further comprising a transmitter configured to send data to a receiver to allow an end user to analyze physiological characteristics of the residual limb.

43. The apparatus of claim 38, wherein the sensor is selected from the group consisting of an oxygen sensor and a pressure sensor.

44. 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.

45. The apparatus of claim 44, 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.

46. The apparatus of claim 44, wherein the sensors are integrated into a wall of the liner.

47. The apparatus of claim 44, wherein at least one sensor extends along a closed distal end of the liner to correspond to the distal end of the residual limb.

48. The apparatus of claim 44, wherein at least one of the sensors is selected from the group consisting of an oxygen sensor and a pressure sensor.

49. The apparatus of claim 44, further comprising a supplementary physiological sensor incorporated into the socket.

50. The apparatus of claim 44, wherein at least one of the elongate strips has a portion folded back onto itself

51. 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.

52. The socket liner system of claim 51, further comprising a data gathering device configured to store the physiological data gathered by the sensor.

53. The socket liner system of claim 52, wherein the data gathering device is a computer.

54. The socket liner system of claim 51, wherein the sensor is a pressure sensor.

55. The socket liner system of claim 51, wherein the liner includes a groove for receiving the sensor.

56. The socket liner system of claim 51, wherein the sensor is a strip provided along an inner surface of the liner.

57. The socket liner system of claim 51, wherein the liner is adapted to receive a residual portion of an amputated leg.

58. 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.

59. The socket liner system of claim 58, wherein the sensor is a strip provided in the liner inner layer.

60. The socket liner system of claim 58, further comprising a transmitter configured to transmit the physiological data to an end user to monitor the health of the residual limb.

61. The socket liner system of claim 58, 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.

62. 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.

63. The socket liner system of claim 62, wherein the sensor is a pressure sensor.

64. The socket liner system of claim 62, wherein the liner includes a groove for receiving the sensor.

65. The socket liner system of claim 62, wherein the liner includes a pocket for receiving the sensor.

66. The socket liner system of claim 62, wherein the sensor is a pressure sensor comprising a strip provided along an inner surface of the liner.

67. The socket liner system of claim 62, wherein the liner is made from two parts adhered together.

68. The socket liner system of claim 62, wherein the liner is adapted to receive a portion of an amputated leg.

69. 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.

70. The socket liner of claim 69, wherein the sensor is an elongate strip configured to be wrapped around a portion of the inner liner.

71. The socket liner of claim 69, further comprising a plurality of sensors.

72. The socket liner of claim 69, further comprising an adhesive disposed between the inner liner and the outer liner.

73. The socket liner of claim 69, further comprising a transmitter configured to send data to a receiver to allow an end user to analyze physiological characteristics of the residual limb.

74. The socket liner of claim 69, wherein the sensor is selected from the group consisting of an oxygen sensor and a pressure sensor.

75. The socket liner of claim 69, wherein the sensor comprises an extending portion that extends outwardly from the open proximal end of the socket liner in a generally longitudinal direction.

76. 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.

77. The prosthetic system of claim 76, wherein the prosthetic device is a foot.

78. The prosthetic system of claim 76, wherein the prosthetic device is a leg.

79. The prosthetic system of claim 76, wherein the sensor is a strip sensor.

80. The prosthetic system of claim 76, wherein the sensor passes over the closed distal end of the tubular body.

81. The prosthetic system of claim 76, wherein the sensor comprises a flexible portion and a rigid portion.

82. The prosthetic system of claim 76, 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.

83. 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.

84. The socket liner system of claim 83, wherein the sensor is a strip sensor.

85. The socket liner system of claim 83, further comprising a transmitter adapted to transmit the physiological data to an end user to monitor the health of the residual limb.

86. The socket liner system of claim 83, further comprising a memory configured to store the physiological data gathered by the sensor.

87. The socket liner of Claim 8, wherein at least one of the inner and outer layers defines one or more grooves into which the one or more sensors are disposed so that a thickness of a portion of the socket liner in which the one or more sensors is embedded is approximately equal to a thickness of a portion of the socket liner in which no sensor is embedded.

88. The socket liner of Claim 8, wherein at least one of the inner and outer layers defines one or more grooves into which the one or more sensors are disposed so that a thickness of the socket liner is substantially constant around a circumference of the socket liner.

89. The socket liner of Claim 8, wherein at least one of the inner and outer layers defines one or more grooves having a depth approximately equal to a thickness of the one or more sensors.

90. The socket liner of Claim 5, wherein the plurality of grooves have a depth approximately equal to a thickness of the one or more sensors.

91. The socket liner of Claim 6, wherein the plurality of pockets are configured so that a thickness of the socket liner is substantially constant around a circumference of the socket liner.