Lower limb prosthesis

• US 6,517,585 B1
• Filed: 05/03/2000
• Issued: 02/11/2003
• Est. Priority Date: 08/15/1997
• Status: Expired due to Term

• Current Assignee: Blatchford Products Limited (CBPE Capital LLP)
• Original Assignee: CHAS A Blatchford & Sons Limited
• Inventors: Lang, Stephen Terry, Sykes, Andrew John, Zahedi, Mir Saeed
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US09/485,800
• Time in Patent Office: 1,014 Days
• Field of Search: 623/24, 623/44, 623/45, 623/43
• US Class Current: 623/24
• CPC Class Codes: A61F 2/64 Knee joints
• CPC Class Codes: A61F 2/70 electrical
• CPC Class Codes: A61F 2/74 fluid , i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/748 Valve systems
• CPC Class Codes: A61F 2002/607 Lower legs
• CPC Class Codes: A61F 2002/704 computer-controlled, e.g. robotic control
• CPC Class Codes: A61F 2002/705 Electromagnetic data transfer for implantable prostheses A61F2250/0002

Abstract

A lower limb prosthesis for an above-knee amputee has an adaptive control system which includes a knee flexion control device arranged to resist flexion at the knee joint both hydraulically and pneumatically by means of a dual piston and cylinder assembly. Sensors arranged to sense knee bending moments and knee flexion angle provide electrical signals which are fed to a processing circuit for automatically adjusting the hydraulic and pneumatic resistance to flexion according to the activity mode of the amputee and, when walking, according to the speed of the cylinder containing hydraulic fluid. The hydraulic resistance to flexion predominates during the stance phase and pneumatic resistance predominates during the swing phase. Provision is made for programmable resistance during level walking, walking on an incline, descending stairs and during a stumble.

Claims

1. A lower limb prosthesis for an above-knee amputee, having an adaptive control system which comprises a knee flexion control device arranged to resist flexion at a knee joint both hydraulically and pneumatically, and an electronic processing circuit electrically coupled to sensor means and a control device for automatically adjusting the hydraulic and pneumatic resistance to knee flexion according to actions of the amputee.

2. A prosthesis according to claim 1, wherein the sensor means is arranged to generate electrical sensor signals in response to loading of the prosthesis, and the control system is arranged such that the knee joint resistance to knee flexion is controlled at least predominately hydraulically during a stance phase of a walking cycle of the prosthesis.

3. A prosthesis according to claim 2, wherein the control system is arranged such that the resistance to knee flexion is controlled at least predominantly pneumatically during a swing phase of the walking cycle of the prosthesis.

4. A prosthesis according to claim 2, wherein the knee flexion control device comprises a piston and cylinder assembly having a chamber containing hydraulic fluid and a chamber containing gas, wherein the volume of each chamber varies according to the degree of knee flexion, the flow of fluid or gas respectively to or from the chambers being controlled by a plurality of valves controlled in response to setting signals from the processing circuit, and wherein the chamber containing hydraulic fluid has an associated bypass means located so as to be effective only within an upper range of angular knee flexion.

5. A prosthesis according to claim 4, without a mechanical extension spring of stiffness greater than 6 lb/in (0.11 kg/mm).

6. A prosthesis according to claim 4, further comprising a mechanical extension spring.

7. A prosthesis according to claim 6, wherein the mechanical extension spring has stiffness less than or equal to 6 lb./in. (0.11 kg./mm).

8. A prosthesis according to claim 2, wherein the sensor means includes a flexion sensor arranged to provide a sensor signal indicative of the degree of flexion of the knee joint.

9. A prosthesis according to claim 8, wherein the flexion sensor comprises the combination of a magnetoresistive transducer and a magnet respectively mounted on parts of the prosthesis which move relatively to each other as the knee joint is flexed.

10. A prosthesis according to claim 1, wherein the control system is arranged such that the resistance to knee flexion is controlled at least predominantly pneumatically during a swing phase of a walking cycle of the prosthesis.

11. A prosthesis according to claim 1 or claim 2, wherein the control system is configured such that flexion is hydraulically resisted substantially only within an initial part of an angular range of flexion of the knee joint from full extension.

12. A prosthesis according to claim 11, wherein the hydraulic resistance to flexion predominates over an initial angular flexion range of from substantially zero to an upper angular limit which is no greater than 35°

.

13. A prosthesis according to claim 12, wherein the upper angular limit is between 30°

and 35°

.

14. A prosthesis according to claim 11, wherein the knee flexion control device comprises a piston and cylinder assembly having a chamber containing hydraulic fluid, wherein the volume of the chamber varies according to the degree of knee flexion, and wherein the chamber has associated bypass means located such that the resistance to movement of the piston and cylinder assembly due to the hydraulic fluid is insignificant over an upper range of angular knee flexion in comparison with the resistance of the assembly due to the hydraulic fluid within the said initial part of the angular range of flexion from full extension.

15. A prosthesis according to claim 14, wherein the bypass means comprises an enlargement of the cylinder over part of the stroke of the piston.

16. A prosthesis according to claim 1, wherein the control system is configured such that the flexion control device provides pneumatic knee extension assistance and hydraulic terminal extension damping during a swing phase of a walking cycle of the prosthesis.

17. A prosthesis according to claim 1, wherein the knee flexion control device is arranged to resist flexion hydraulically and pneumatically simultaneously during a stance phase of a walking cycle of the prosthesis with the hydraulic resistance predominating such that adjustment of the hydraulic and pneumatic resistance respectively provides for coarse and fine control of flexion resistance.

18. A prosthesis according to claim 1, wherein the sensor means and the processing circuit are operable together to generate a descent control signal indicative of the amputee walking down a slope as opposed to walking on a level surface, and wherein the processing circuit is operable to feed a setting signal to the control device to increase the hydraulic resistance to increasing knee flexion in response to the descent control signal.

19. A prosthesis according to claim 18, wherein the sensor means includes a sensor located at the knee level to provide a sensor output signal indicative of a knee bending moment, the processing circuit being operable to process the sensor output signal to detect the amputee descending a slope and to generate the descent control signal.

20. A prosthesis according to claim 19, wherein the processing circuit is operable to generate a signal representative of an integral of the sensor output signal over a period of time during a stance phase of a walking cycle of the prosthesis and to generate the descent control signal in response to the integral exceeding a predetermined value.

21. A prosthesis according to claim 18, wherein the processing circuit monitors an output signal from the sensor means to detect an increase in the knee bending moment with reference to a predetermined threshold, the increase occurring over a period of time representing a major part of a stance phase of a walking cycle of the prosthesis, thereby to produce the descent control signal.

22. A prosthesis according to claim 1, wherein:

the control device is arranged to resist knee flexion hydraulically during a stance phase of a walking cycle of the prosthesis,

the sensor means are for generating electrical sensor signals in response to loading of the prosthesis, and

the processing circuit is arranged to feed a descent control signal to the control device in response to detection of the amputee descending an incline, the descent control signal causing an increase in the resistance of the control device to knee flexion compared with a resistance set for level walking.

23. A prosthesis according to claim 22, wherein the sensor means comprise a sensor located at the knee level of the prosthesis and arranged to generate a sensor signal which is a function of a bending moment at the knee tending to cause knee flexion.

24. A prosthesis according to claim 23, wherein the processing circuit is arranged to generate the descent control signal as a function of an integral of the sensor signal with respect to time.

25. A prosthesis according to any of claims 22 to 24, wherein the sensor means include a flexion sensor arranged to provide a sensor signal indicative of a degree of flexion of the knee joint.

26. A prosthesis according to claim 1, wherein:

the control device is arranged to resist flexion at the knee joint hydraulically during a stance phase of a walking cycle of the prosthesis,

the sensor means are for generating electrical sensor signals in response to loading of the prosthesis at the knee level, and

the processing circuit is arranged automatically to adjust the resistance to knee flexion in response to changes in the sensor signals occurring when the amputee moves from walking on a level surface to walking down an incline and vice versa.

27. A prosthesis according claim 26, wherein the sensor means are arranged to sense a load on the prosthesis and the degree of flexion, and wherein the processing circuit uses the sensor signals to monitor both of these parameters with respect to a predetermined time period in the order of 3 to 7 seconds to sense a sitting condition and a standing condition.

28. A prosthesis according to claim 26, wherein the processing circuit is arranged automatically to adjust the resistance to flexion in response to changes in the sensor signals occurring when the amputee at least one of sits down, stands up, stops walking and starts walking.

29. A prosthesis according to claim 28, wherein the sensor means are arranged to sense changes in a bending moment applied to the knee.

30. A prosthesis according to claim 26 or claim 28, wherein the sensor means are arranged to sense changes in a bending moment applied to the knee.

31. A prosthesis according to claim 30, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

32. A prosthesis according to claim 30, wherein the sensor means comprises a transducer mounted on a structural member of the prosthesis substantially adjacent a pivot axis of the knee.

33. A prosthesis according to claim 32, wherein the structural member comprises a first part and a second part, wherein the first part is a lever arm connected for pivotal movement relative to the other structural member part about an axis substantially parallel to but spaced from the knee axis of rotation, and wherein the transducer is mounted so as to produce a sensor signal representative of the deflection of the lever arm relative to the second structural part.

34. A prosthesis according to claim 33, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

35. A prosthesis according to claim 32, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

36. A prosthesis according to claim 32, wherein the sensor means comprises a force transducer and the structural member has two parts which move relative to each other according to a load applied to the prosthesis, and wherein the force transducer is mounted to one of the two parts so as to be acted upon by the other part and to produce a sensor signal dependent on the load applied to the prosthesis.

37. A prosthesis according to claim 36, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

38. A prosthesis according to claim 36, wherein the structural member is associated with a thigh part of the prosthesis.

39. A prosthesis according to claim 38, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

40. A prosthesis according to claim 38, wherein the structural member is associated with the thigh part of the prosthesis and the structural member parts comprise a lever arm and a knee chassis, with the lever arm carrying a stump fixing assembly and the knee chassis pivotally connected to a shin part of the prosthesis, the lever arm being resiliently deflectable relative to the knee chassis.

41. A prosthesis according to claim 40, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

42. A prosthesis according to claim 40, further including a resilient buffer between the lever arm and the knee chassis, the transducer comprising a force transducer positioned between the buffer and one of the lever arm and the knee chassis.

43. A prosthesis according to claim 42, wherein the processing circuit is arranged to generate a descent control signal and to feed the descent signal to the knee flexion control device so as to set an increased stance phase resistance to knee flexion when an integral of a bending moment at the knee as sensed by the sensor means and normalized with respect to a step period exceeds a stored threshold value, whereby the resistance to flexion in the stance phase is higher when the amputee is descending a slope than during level walking.

44. A prosthesis according to claim 1, wherein:

the control device comprises a hydraulic control device to resist knee flexion hydraulically during a stance phase of a walking cycle of the prosthesis,

the sensor means generate electrical sensor signals in response to loading of the prosthesis, and

the processing circuit is arranged to feed a descent control signal to the control device in response to detection of the amputee descending an incline, as a function of an integral of a quantity relating to a bending moment applied to the prosthesis over at least a major part of the stance phase.

45. A prosthesis according to claim 44, wherein the processing circuit is arranged to generate a ramp index, $\mathrm{where}$

 



I=1T

∫

t0t1

F,

t

and T is the step period or stance phase duration, t₀ and t₁ are the start and finish of a measuring period representing at least the major part of the stance phase, and F is a sensed parameter related to the a bending moment, and wherein a descent control signal is generated when I is greater than a stored threshold value.

46. An adaptive control system for a lower limb prosthesis intended for an above-knee amputee, comprising a knee flexion control device for resisting flexion at the knee joint both hydraulically and pneumatically, at least one sensor device for generating electrical sensor signals in response to loading of the prosthesis, and an electronic processing circuit electrically coupled to each of the sensor device and the control device for automatically adjusting the hydraulic and pneumatic resistance to knee flexion according to the actions of the amputee.

47. A system according to claim 46, wherein the processing circuit is operable in a program mode and an automatic operation mode, the control system further comprising a remotely operable control unit allowing programming of the system in the program mode, the control device including control means for incrementally increasing or decreasing a hydraulic flexion resistance in real time during an activity test.

48. A system according to claim 46, wherein said at least one sensor device is arranged to sense forces and/or motions at the knee of the prosthesis, and wherein the processing circuit detects actions of the amputee in response to signals generated by said at least one sensor device.

49. A system according to claim 48, wherein the processing circuit is arranged to detect at least one of descending an incline and a stumble condition.

50. A system according to claim 49, wherein said at least one sensor device comprises a sensor for producing a signal representative of a knee bending moment, and wherein the processing circuit is arranged to produce a descent control signal by recognising a signal pattern from said at least one sensor device occurring during a stance phase of the prosthesis, which pattern is associated with descending an incline.

51. A system according to claim 50, wherein the signal pattern recognition comprises comparing a normalised knee bending moment integral derived over at least a portion of the stance phase with a threshold value.

52. A system according to claim 49, wherein said at least one sensor device comprises a knee flexion angle sensor for producing an electrical signal representative of a flexion angle of the knee, and wherein the processing circuit is arranged to produce a stumble mode signal when the said flexion angle signal is indicative of an abnormally short knee extension period.

53. A system according to claim 49, wherein said at least one sensor device comprises a knee flexion angle sensor for producing an electrical signal representative of a flexion angle of the knee, and wherein the processing circuit is arranged to produce a stumble mode signal when the said flexion angle signal is indicative of a positive knee flexion angle gradient following a negative knee flexion angle gradient during a knee flexed state.

54. A system according to claim 49, wherein said at least one sensor device comprises a knee flexion angle sensor for producing an electrical signal representative of a flexion angle of the knee, and wherein the processing circuit is arranged to produce a stumble mode signal when the said flexion angle signal is indicative of an abnormally increasing flexion angle during a stance phase of the prosthesis.

55. A system according to claim 49, wherein said at least one sensor device comprises a knee flexion angle sensor for producing an electrical signal representative of a flexion angle of the knee, and wherein the processing circuit is arranged to produce a stair descent signal when said flexion angle signal is representative of a higher peak knee flexion