Dynamic variable geometry fitting system for use with a body appliance

• US 6,585,774 B2
• Filed: 04/24/2001
• Issued: 07/01/2003
• Est. Priority Date: 04/25/2000
• Status: Expired due to Term

• Current Assignee: Simbex
• Original Assignee: Simbex
• Inventors: Nelson, David F., Dean, Robert C. Jr., Blanchard, Mark W., Braley, Chad S., Mayor, Michael B.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/840,955
• Publication Number:
  US 20020099450A1
• Time in Patent Office: 798 Days
• Field of Search: 623/37, 623/38, 623/36, 623/34, 623/33
• US Class Current: 623/37
• CPC Class Codes: A61F 2/68 Operating or control means
• CPC Class Codes: A61F 2/74 fluid , i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/748 Valve systems
• 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 2/7843 Inflatable bladders
• CPC Class Codes: A61F 2002/501 having an inflatable pocket filled with fluid, i.e. liquid or gas
• CPC Class Codes: A61F 2002/7655 for measuring fluid pressure
• CPC Class Codes: A61F 2002/802 Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump
• CPC Class Codes: A61F 2002/805 having an air valve

Abstract

A dynamic variable geometry fitting system with fluid-filled bladders and automatically regulating their volumes to provide a continuously secure fit. This system can vary volume continuously to accommodate natural variation in an amputee'"'"'s residuum. It makes reliable suction retention of a prosthesis easier for the prosthetist to achieve while reducing the potential for tissue lesions. By maintaining a continuous, secure fit, the amputee'"'"'s sense of confidence and willingness to use the prosthesis increases.

Claims

1. A variable geometry attachment fitting system for use in conjunction with a body appliance to be removably attached to a body part, comprising:

a reservoir of non-leaking material, said reservoir having reservoir filling means for adding fluid to or removing fluid from said reservoir;

at least one pressure bladder made of a substantially pliable fluid-tight material capable of conforming to at least a portion of the appropriate soft tissue areas of the body part, said at least one pressure bladder having a fluid inlet, wherein said at least one pressure bladder is disposed between the body part and the body appliance;

at least one pumping bladder made of a substantially pliable fluid-tight material, said at least one pumping bladder operates as an automatic fluid pump communicating between said reservoir and said at least one pressure bladder for delivering pressurized fluid stored in said reservoir to said at least one pressure bladder, such that the pressure within said at least one pressure bladder may be increased with movement;

a fluid circuit operably interconnected between said reservoir, said at least one pumping bladder, and said at least one pressure bladder, said fluid circuit including pressure control means for regulating and maintaining a predetermined pressure in said at least one pressure bladder; and

said pressure control means comprises means for providing controlled leakage of the fluid from within said at least one pressure bladder, such that the pressure within said at least one pressure bladder may be decreased.

2. The system as recited in claim 1, comprises a plurality of pressure bladders.

3. The system as recited in claim 1, wherein said pumping bladder also acts as a pressure bladder.

4. The system as recited in claim 3, wherein said pumping bladder and said at least one pressure bladder constitute a single unit.

5. The system as recited in claim 1, wherein said pressure control means comprises pressure regulation means for allowing excess fluid to return to said reservoir, and said pressure regulation means includes at least one pressure regulator.

6. The system as recited in claim 5, wherein said pressure regulation means further comprises at least one pressure relief regulator.

7. The system as recited in claim 5, wherein said leakage means comprises at least one leakage resistor.

8. The system as recited in claim 7, wherein said at least one leak resistor continuously returns fluid to said reservoir.

9. The system as recited in claim 5, wherein said pressure regulation means further comprises at least one fluid bypass return.

10. The system as recited in claim 5, wherein said pressure control means further comprises at least one flow control valve for preventing fluid from flowing between said at least one pumping bladder and said at least one pressure bladder, and back into said reservoir.

11. The system as recited in claim 5, wherein said pressure control means further comprises at least one filter for preventing particulate debris from entering said at least one pumping bladder and said at least one pressure bladder, and clogging said fluid circuit.

12. The system as recited in claim 5, wherein said at least one pressure relief regulator is set at approximately a tissue ischemic limit of said body part.

13. The system as recited in claim 1, wherein the body part is a residuum.

14. The system as recited in claim 1, wherein the body appliance is a prosthesis.

15. The system as recited in claim 1 wherein the body appliance comprises a means for encompassing said reservoir, said at least one pressure bladder, said at least one pumping bladder and said fluid circuit.

16. The system as recited in claim 15, wherein the body appliance is a prosthesis.

17. The system as recited in claim 15, wherein the body appliance is a ski boot.

18. The system as recited in claim 15, wherein the body appliance is a shoe.

19. The system as recited in claim 15, wherein the body appliance is a boot.

20. The system as recited in claim 15, wherein the body appliance is a sneaker.

21. The system as recited in claim 1, wherein said fluid circuit includes a fluid conduit network.

22. The system as recited in claim 1, wherein said reservoir filling means is a septum.

23. The system as recited in claim 1, wherein said reservoir comprises a fluid consumption indicator.

24. The system as recited in claim 1, wherein said at least one pressure bladder and said at least one pumping bladder are made of biocompatible medical grade urethane material.

25. The system as recited in claim 1, wherein said at least one pressure bladder and said at least one pumping bladder are made of non-biocompatible medical grade urethane material and the body part is not in direct contact with said at least one pressure bladder and at least one pumping bladder.

26. A fluid, volume-compensating attachment fitting system comprising:

engaging means disposed between two opposing objects for applying a sufficient force to the surfaces of the two opposing objects where a first opposing object is removably retained within a second opposing object;

pressurizing means for automatically increasing pressure within said engaging means, whereby said engaging means expands and fills the volume between the two opposing objects to a predetermined pressure, such that the pressure within said engaging means may be increased with movement;

pressure control means for regulating the predetermined pressure within said engaging means; and

said pressure control means comprises means for providing controlled leakage of the fluid from within said engaging means, such that the pressure within said engaging means may be decreased.

27. The system as recited in claim 26, wherein said engaging means comprises at least one engaging bladder.

28. The system as recited in claim 26, wherein said pressurizing means comprises at least one pumping bladder.

29. The system as recited in claim 26, wherein said pressurizing means also acts as an engaging means.

30. The system as recited in claim 26, wherein said pressure means and said engaging means are a single unit.

31. The system as recited in claim 26, wherein said pressure control means comprises pressure regulation means for allowing excess fluid to return to said reservoir, and said pressure regulation means includes at least one pressure regulator, at least one pressure relief regulator, at least one leakage resistor, at least one fluid bypass return, and at least one flow control valve.

32. The system as recited in claim 31, wherein said fluid circuit includes a fluid conduit network.

33. An automatic force applying retention system, comprising:

a plurality of bladders being disposed between a body part and a body appliance;

means for automatically adjusting said plurality of bladders with a fluid, wherein said plurality of bladders cooperate to define a body part engaging surface, said body part engaging surface of said plurality of bladders being capable of conforming to at least a portion of an outer surface of said body part when said plurality of bladders are inflated and filling a space between the body part and the body appliance; and

said means for automatically adjusting said plurality of bladders comprise a pumping bladder for automatically supplying pressurized fluid to a plurality of pressure bladders upon movement of the body part and leakage means for providing controlled leakage of pressurized fluid from said plurality of bladders.

34. The system as recited in claim 33, wherein said means for automatically inflating said plurality of bladders further comprises an independent pressure control means for each of said plurality of bladders.

35. The system as recited in claim 33, wherein said means for automatically inflating said plurality of bladders further comprises a single pressure control means for said plurality of bladders.

36. The system as recited in claim 33, wherein said means for automatically inflating said plurality of pressure bladders comprises at least one pump and at least one valve for selectively inflating and deflating said plurality of pressure bladders separately and independently to achieve a comfortable and secure fit of the body appliance on the body part.

37. The system as recited in claim 33, wherein said means for automatically inflating is actuated while walking.

38. The system as recited in claim 33, wherein said means for automatically inflating is actuated by manual means, electronic means, electromechanical means, magnetohydrodynamic means or a combination thereof.

39. The system as recited in claim 38, wherein said means for automatically inflating is actuated by a negative pressure in said pumping bladder such that said pressurized fluid is drawn into said pumping bladder during a portion of pumping cycle defined by movement of said body part and by a positive pressure in said pumping bladder such that said pressurized fluid is pumped from said pumping bladder during a different portion of pumping cycle defined by movement of said body part.

40. The system as recited in claim 33, wherein said fluid is substantially incompressible.

41. The system as recited in claim 33, wherein said fluid is incompressible.

42. A lower-limb prosthesis socket system, comprising:

a socket, said socket having a lower-limb prosthesis associated therewith;

a reservoir, said reservoir capable of being filled with a fluid;

at least one pumping bladder, said at least one pumping bladder being positioned near a distal-end of said socket;

a plurality of intrasocket bladders, said at least one pumping bladder being capable of pumping fluid to said plurality of intrasocket bladders during a positive pressure phase and said at least one pumping bladder being capable of drawing fluid from said reservoir during a negative pressure phase such that said plurality of intrasocket bladders create a continuously secure fit for the lower-limb prosthesis socket to a residuum, which is naturally changing volume; and

a plurality of conduits, said plurality of conduits connect said reservoir to said at least one pumping bladder and said plurality of intrasocket bladders, whereby said at least one pumping bladder and said plurality of intrasocket bladders are maintained at a predetermined pressure.

43. The system as recited in claim 42 further comprising an inlet check valve and an outlet check valve, said check valves being disposed between said reservoir and said at least one pumping bladder connected by said conduits, said plurality of check values prevent the fluid from flowing from said plurality of intrasocket bladders back into said at least one pumping bladder, whereby said check valves define pumping action of said at least one pumping bladder.

44. The system as recited in claim 42, further comprising at least one adjustable pressure-relief valve, said at least one adjustable pressure-relief valve being disposed between said reservoir and said at least one pumping bladder connected by said conduits, whereby said at least one adjustable pressure-relief valve can set the pressure in said plurality of intrasocket bladders during stance.

45. The system as recited in claim 42, further comprising at least one leakage resistor being disposed between said plurality of intrasocket bladders and said reservoir, said leakage resistor being disposed between said at least one pumping bladder and said reservoir, whereby said at least one leakage resistor allows fluid to leak from said intrasocket bladders to said reservoir, thereby maintaining a predetermined pressure automatically in said plurality of intrasocket bladders and said pumping bladder below the ischemic limit to relax the pressure against the residuum if stasis is maintained for more than a few minutes.

46. The system as recited in claim 42, further comprising at least one discharge valve being disposed between said bladders and said reservoir, whereby said at least one discharge valve discharges all of the liquid from said plurality of intrasocket bladders and said at least one pumping bladder back into said reservoir to facilitate the removal of said lower-limb prosthesis.

47. The system as recited in claim 42, said reservoir being made of a flexible material, whereby said flexible material will collapse and expand as fluid levels fluctuate.

48. The system as recited in claim 42, wherein said reservoir comprises a reservoir filling means, said reservoir filling means includes an opening to receive a syringe or equivalent for filling and draining said reservoir with fluid.

49. The system as recited in claim 42, wherein said reservoir further comprises a fluid capacity between 100-300 ml.