Diaphragm based spontaneous inflation inhibitor in a pump for an inflatable prosthesis

• US 20030065249A1
• Filed: 12/06/2002
• Published: 04/03/2003
• Est. Priority Date: 12/27/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Charles C. Kuyava, David W. Clark, John W. Westrum Jr
• Inventors: Kuyava, Charles C., Westrum, John W. Jr., Clark, David W.
• Granted Patent: US 6,935,847 B2
• Time in Patent Office: Days
• US Class Current: 600/40
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: F16K 15/066 with a plurality of valve members
• CPC Class Codes: F16K 2200/204 in series
• CPC Class Codes: F16K 2200/3053 Helicoidal springs of variable pitch, diameter or spring rate
• CPC Class Codes: Y10T 137/1842 Ambient condition change responsive
• CPC Class Codes: Y10T 137/7777 Both valves spring biased
• CPC Class Codes: Y10T 137/7838 Plural
• CPC Class Codes: Y10T 137/7842 Diverse types
• CPC Class Codes: Y10T 137/785 With retarder or dashpot

Abstract

A pump assembly for a penile implant is provided having a mechanism which prevents spontaneous inflation of the cylinders implanted within the user. The preventative mechanism uses overpressure generated by the reservoir during unintentional compression to effectively seal the pump assembly from unintended fluid flow. The prevention mechanism itself creates all necessary forces to prevent the undesired fluid flow to the cylinders. This is accomplished by incorporating appropriate mechanisms within the pump itself.

Claims

1. A pump assembly for an implantable prosthesis, comprising:

a housing having a fluid passageway, the fluid passageway having an inlet and an outlet;

a first flow valve located within the fluid passageway between the inlet and the outlet; and

an outlet sealing mechanism located within the housing that selectively and substantially seals the outlet in response to a fluid pressure within at least a portion of the housing that exceeds a predetermined level.

2. The pump assembly of claim 1 wherein fluid pressure controls the outlet sealing mechanism.

3. The pump assembly of claim 1, further comprising a second flow valve located within the fluid passageway.

4. The pump assembly of claim 1, wherein the outlet sealing mechanism includes:

a bypass passageway having a first end which is in fluid communication with the inlet and a second end which is in fluid communication with a chamber, wherein the amount of fluid pressure within the chamber selectively prevents fluid flow through the outlet.

5. The pump assembly of claim 4, further comprising:

a flexible abutting wall disposed between the chamber and the first flow valve so that the abutting wall is caused to contact the first flow valve and urge the first flow valve into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

6. The pump assembly of claim 5 wherein a planar surface area of the abutting wall that is disposed within the chamber is larger than a surface area of a portion of the first flow valve located within an inlet side of the fluid passageway when the first flow valve is in the closed position.

7. The pump assembly of claim 6, further comprising a second flow valve disposed within the fluid passageway, between the inlet and the first flow valve.

8. The pump assembly of claim 4, further comprising:

a diaphragm located within the chamber, the chamber being in fluid communication with the fluid passageway and the outlet so that when the diaphragm is in a first position, fluid is able to flow from the fluid passageway and through the outlet, and when the diaphragm is in a second position, no fluid is allowed to flow through the outlet.

9. The pump assembly of claim 8 wherein the diaphragm is caused to move to the second position when fluid pressure within the chamber exceeds a predetermined level.

10. The pump assembly of claim 8 wherein an amount of surface area on the diaphragm that is exposed to the bypass passageway is larger than an amount of surface area on the diaphragm that is exposed to the fluid passageway.

11. The pump assembly of claim 4 wherein the chamber surrounds a collapsible portion of the outlet and when the fluid pressure within the chamber exceeds a predetermined level the collapsible portion of the outlet is caused to collapse which prevents fluid flow through the outlet.

12. The pump assembly of claim 1 wherein the outlet sealing mechanism further comprises:

an overpressure chamber fluidly coupled to the inlet; and

an output passageway forming a part of the fluid passageway between the first flow valve and the outlet, wherein the output passageway includes a narrow throat portion located proximate the overpressure chamber so that when the fluid pressure within the overpressure chamber exceeds a predetermined value an expansion of the overpressure chamber occurs which causes the throat portion to close.

13. The pump assembly of claim 12, further comprising:

a first output chamber, forming part of the output passageway; and

a second output chamber, forming part of the output passageway, so that the first and second output chambers form a moveable compression wall that is coupled with the overpressure chamber so that expansion of the overpressure chamber causes the compression wall to move which closes the throat portion.

14. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, coupleable to a reservoir;

a fluid outlet from the housing, coupleable to an inflatable cylinder;

a fluid passageway coupling the inlet to the outlet;

an input chamber coupling the inlet to the fluid passageway;

a first check valve disposed within the fluid passageway and biased towards a closed position;

a second check valve disposed within the fluid passageway and biased towards a closed position;

a pump bulb in fluid communication with the fluid passageway between the first and second check valves; and

a bypass passageway fluidly coupling the input chamber to an expansion chamber located proximate the second check valve, wherein the expansion chamber includes a flexible wall portion that is able to contact the second check valve and urge the second check valve towards the closed position when fluid pressure within the expansion chamber exceeds a predetermined value.

15. The prosthesis of claim 14 wherein a surface area of the wall within the expansion chamber is larger than a surface area of a portion of the second check valve located within an inlet side of the fluid passageway when the second check valve is in the closed position.

16. The prosthesis of claim 14 wherein a fluid pressure level generated by a compression of the pump bulb is sufficient to open the second check valve when the flexible wall portion is urging the second check valve towards a closed position.

17. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, coupleable to a reservoir;

a fluid outlet from the housing, coupleable to an inflatable cylinder;

a fluid passageway coupling the inlet to the outlet;

an input chamber coupling the inlet to the fluid passageway;

a first check valve disposed within the fluid passageway and biased towards a closed position;

a second check valve disposed within the fluid passageway and biased towards a closed position;

a pump bulb in fluid communication with the fluid passageway between the first and second check valves;

an expansion chamber located proximate the second check valve,;

a bypass passageway fluidly coupling the input chamber to the expansion chamber; and

a diaphragm disposed within the expansion chamber, moveable between a first position that allows fluid flow between the fluid passage and the outlet, and a second position that prevents fluid flow between the fluid passage and the outlet, wherein the diaphragm is caused to move to the second position when fluid pressure within the expansion chamber exceeds a predetermined value.

18. The prosthesis of claim 17 wherein a surface area of the diaphragm exposed to a bypass passageway side of the expansion chamber is larger than a surface area of the diaphragm exposed to a fluid passageway side of the diaphragm.

19. The prosthesis of claim 18 wherein a fluid pressure level generated by a compression of the pump bulb is sufficient to move the diaphragm from the second position to the first position.

20. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, coupleable to a reservoir;

a fluid outlet from the housing, coupleable to an inflatable cylinder;

a fluid passageway coupling the inlet to the outlet;

an input chamber coupling the inlet to the fluid passageway;

a first check valve disposed within the fluid passageway and biased towards a closed position;

a second check valve disposed within the fluid passageway and biased towards a closed position;

a pump bulb in fluid communication with the fluid passageway between the first and second check valves;

a compression chamber surrounding a compressible portion of the outlet; and

a bypass passageway fluidly coupling the input chamber to the compression chamber so that if a fluid pressure level within the compression chamber exceeds a predetermined level the compressible portion of the outlet is compressed preventing fluid flow through the outlet.

21. The prosthesis of claim 20 wherein a fluid pressure level generated by a compression of the pump bulb is sufficient to expand the compressible portion of the outlet.

22. A method of preventing inflation of an implantable prosthetic comprising the steps of:

biasing a valve assembly such that an outlet is substantially closed; and

using pressure increases from the inlet to supplement the biasing of the valve assembly.

23. The method of claim 22, wherein the step of using pressure includes:

preventing fluid flow through the outlet by selectively varying fluid pressure within a bypass passageway having a first end which is in fluid communication with an inlet and a second end which is in fluid communication with a chamber.

24. The method of claim 23, further comprising the steps of:

displacing a flexible abutting wall disposed between the chamber and the valve assembly so that the abutting wall is caused to contact the valve assembly and urge the valve assembly into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

25. The method of claim 23, further comprising the steps of:

deflecting a diaphragm located within the chamber, the chamber being in fluid communication with the inlet and the outlet so that when the diaphragm is in a first position, fluid is able to flow from the inlet and through the outlet, and when the diaphragm is in a second position, no fluid is allowed to flow through the outlet.

26. A pressure lock out arrangement for an inflatable prosthesis comprising:

a housing having an inlet and an outlet;

a valve disposed between the inlet and the outlet;

the valve being biased toward substantially sealing the outlet; and

a supplemental biasing mechanism responsive to pressure increases from the inlet to increase the biasing of the valve toward substantially sealing the outlet.

27. The pressure lock out of claim 26, wherein the supplemental biasing mechanism includes:

a bypass passageway having a first end which is in fluid communication with the inlet and a second end which is in fluid communication with a chamber, wherein the amount of fluid pressure within the chamber selectively prevents fluid flow through the outlet.

28. The pressure lock out of claim 27, further comprising:

a flexible abutting wall disposed between the chamber and the valve so that the abutting wall is caused to contact the valve and urge the valve into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

29. The pressure lock out of claim 27, further comprising:

a diaphragm located within the chamber, the chamber being in fluid communication with the inlet and the outlet so that when the diaphragm is in a first position, fluid is able to flow from the inlet and through the outlet, and when the diaphragm is in a second position, no fluid is allowed to flow through the outlet.

30. The pressure lock out of claim 27 wherein the chamber surrounds a collapsible portion of the outlet and when the fluid pressure within the chamber exceeds a predetermined level the collapsible portion of the outlet is caused to collapse which prevents fluid flow through the outlet.

31. The pressure lock out of claim 26 wherein the supplemental biasing mechanism further comprises:

an overpressure chamber fluidly coupled to the inlet; and

an output passageway forming a part of a fluid passageway between the valve and the outlet, wherein the output passageway includes a narrow throat portion located proximate the overpressure chamber so that when the fluid pressure within the overpressure chamber exceeds a predetermined value an expansion of the overpressure chamber occurs which causes the throat portion to close.

32. A pump and valve assembly for an inflatable prosthetic comprising:

a housing having an inlet and an outlet;

a valve controlling fluid flow between the inlet and the outlet; and

an outlet sealing mechanism responsive to pressure increases from the inlet;

the valve and the outlet sealing mechanism being integrated and substantially enclosed in the housing.

33. The pump assembly of claim 32, wherein the outlet sealing mechanism includes:

a bypass passageway having a first end which is in fluid communication with the inlet and a second end which is in fluid communication with a chamber, wherein the amount of fluid pressure within the chamber selectively prevents fluid flow through the outlet.

34. The pump and valve assembly of claim 33, further comprising:

a flexible abutting wall disposed between the chamber and the valve so that the abutting wall is caused to contact the valve and urge the valve into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

35. The pump and valve assembly of claim 33, further comprising:

a diaphragm located within the chamber, the chamber being in fluid communication with the inlet and the outlet so that when the diaphragm is in a first position, fluid is able to flow from the inlet and through the outlet, and when the diaphragm is in a second position, no fluid is allowed to flow through the outlet.

36. The pump and valve assembly of claim 33 wherein the chamber surrounds a collapsible portion of the outlet and when the fluid pressure within the chamber exceeds a predetermined level the collapsible portion of the outlet is caused to collapse which prevents fluid flow through the outlet.

37. A pump assembly for an implantable prosthesis, comprising:

a housing having a fluid passageway, the fluid passageway having an inlet and an outlet, wherein the inlet is in fluid communication with a reservoir;

a first flow valve located within the fluid passageway between the inlet and the outlet;

a second flow valve located within the fluid passageway between the first flow valve and the inlet, wherein an intermediate chamber is defined between the first flow valve and the second flow valve within the fluid passageway;

an expansion chamber in fluid communication with the inlet; and

a flexible member located within the expansion chamber that selectively and substantially seals the outlet in response to a fluid pressure within the expansion chamber that exceeds a predetermined level.

38. The pump assembly of claim 37 wherein the flexible member is an abutting wall disposed between the expansion chamber and the first flow valve so that the abutting wall is caused to contact the first flow valve and urge the first flow valve into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

39. The pump assembly of claim 37 wherein the flexible member is a diaphragm that selectively seals the outlet.

40. The pump assembly of claim 37, further comprising:

a return channel coupling the intermediate chamber and the expansion chamber;

a first check valve located within the return channel and only permitting fluid flow in the direction from the expansion chamber to the intermediate chamber;

a bypass channel coupling the inlet and the expansion chamber; and

a second check valve located within the bypass channel and only permitting fluid flow in the direction from the inlet to the expansion chamber.

41. The pump assembly of claim 40 wherein the second check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve

42. The pump assembly of claim 37, further comprising:

a return channel fluidly coupling the inlet, the intermediate chamber and the expansion chamber;

a fluid resistor located within the return channel between the inlet and the intermediate chamber;

a first check valve located within the return channel between the intermediate chamber and the expansion chamber that only allows fluid flow in a direction from the expansion chamber towards the intermediate chamber;

a bypass channel fluidly coupling the inlet to the expansion chamber; and

a second check valve located within the bypass channel that only allows fluid flow in a direction from the inlet towards the expansion chamber.

43. The pump assembly of claim 42 wherein the second check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve

44. The pump assembly of claim 37, further comprising:

a return channel fluidly coupling the inlet, the intermediate chamber and the expansion chamber;

a first fluid resistor located within the return channel between the inlet and the intermediate chamber;

a second fluid resistor located within the return channel between the intermediate chamber and the expansion chamber;

a bypass channel fluidly coupling the inlet to the expansion chamber; and

a first check valve located within the bypass channel that only allows fluid flow in a direction from the inlet towards the expansion chamber.

45. The pump assembly of claim 44 wherein the first check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve

46. The pump assembly of claim 37, further comprising:

a bypass passageway fluidly coupling the inlet to the expansion chamber;

an intermediate passageway fluidly coupling the intermediate chamber to the bypass passageway;

a first fluid resistor located within the intermediate passageway and impeding fluid flow between the intermediate chamber and the bypass passageway;

a second fluid resistor located within the bypass passageway;

a bypass channel fluidly coupling portions of the bypass passageway on opposite sides of the second fluid resistor, effectively bypassing the second fluid resistor within the bypass passageway; and

a first check valve located within the bypass channel that only allows fluid flow in a direction from the inlet towards the expansion chamber.

47. The pump assembly of claim 46 wherein the first fluid resistor passes a higher volume of fluid per unit time than the second fluid resistor.

48. The pump assembly of claim 46 wherein the second fluid resistor is located between the expansion chamber and the intermediate passageway.

49. A pump assembly for an implantable prosthesis, comprising:

a housing having a fluid passageway, the fluid passageway having an inlet and an outlet;

a first flow valve located within the fluid passageway between the inlet and the outlet; and

a rigid member partially surrounding the fluid passageway.

50. The pump assembly of claim 49 wherein the rigid member has at least on hole bored therethrough.

51. A method of preventing inadvertent inflation of an implantable prosthetic comprising the steps of:

biasing a first valve assembly in a fluid passageway between an inlet and an outlet such that the outlet is substantially closed;

biasing a second valve assembly in the fluid passageway such that the fluid passageway is substantially closed to the inlet, wherein the first valve assembly and the second valve assembly define an intermediate chamber therebetween; and

using pressure increases from an inlet to supplement the biasing of the valve assembly by preventing fluid flow through the outlet by selectively varying fluid pressure within an expansion chamber which is in fluid communication with the inlet.

52. The method of claim 51, wherein using pressure further comprises the steps of:

displacing a flexible abutting wall disposed between the expansion chamber and the valve assembly so that the abutting wall is caused to contact the valve assembly and urge the valve assembly into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.

53. The method of claim 52, further comprising:

preventing fluid flow out of the expansion chamber once the inadvertent pressure increase has been reduced until a pressure of the fluid within the intermediate chamber is lower than a pressure of the fluid within the expansion chamber.

54. The method of claim 52 where preventing fluid flow is accomplished using at least one check valve.

55. The method of claim 52 where preventing fluid flow is accomplished using at least one fluid resistor.

56. The method of claim 52 where preventing fluid flow is accomplished using at least one check valve and at least one fluid resistor.

57. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, coupleable to a reservoir;

a fluid outlet from the housing, coupleable to an inflatable cylinder;

a reservoir chamber disposed within the housing and fluidly coupled to the inlet;

a fluid passageway fluidly coupled to the reservoir chamber;

a first check valve disposed within the fluid passageway and biased towards a closed position;

a second check valve disposed within the fluid passageway and biased towards a closed position;

a pump bulb in fluid communication with the fluid passageway between the first and second check valves;

an overpressure chamber fluidly coupled to the inlet; and

an output passageway, fluidly coupling the fluid passageway to the outlet, wherein the output passageway narrows in a throat region proximate the overpressure chamber so that as fluid pressure within the overpressure chamber increases, the overpressure chamber is caused to expand and close the throat region.

58. The prosthesis of claim 57, further comprising:

an output chamber, forming part of the output passageway, so as to define a moveable compression wall that is coupled with the overpressure chamber so that expansion of the overpressure chamber causes the compression wall to move which closes the throat region.

59. The prosthesis of claim 58 wherein a fluid pressure level generated by a compression of the pump bulb is sufficient to open the closed throat region.

60. A pump and valve assembly for an inflatable prosthetic comprising:

a housing having an inlet and an outlet;

a valve controlling fluid flow between the inlet and the outlet; and

an outlet sealing mechanism responsive to inadvertent pressure increases from the inlet;

the valve and the outlet sealing mechanism being integrated and substantially enclosed in the housing.

61. The pump and valve assembly of claim 60 wherein the outlet sealing mechanism further comprises:

an overpressure chamber fluidly coupled to the inlet; and

an output passageway forming a part of a fluid passageway between the valve and the outlet, wherein the output passageway includes a narrow throat portion located proximate the overpressure chamber so that when the fluid pressure within the overpressure chamber exceeds a predetermined value an expansion of the overpressure chamber occurs which causes the throat portion to close.