Spontaneous inflation inhibitor for inflatable prosthesis

• US 6,935,847 B2
• Filed: 12/06/2002
• Issued: 08/30/2005
• Est. Priority Date: 12/27/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Kuyava, Charles C., Westrum, John W. Jr., Clark, David W.
• Primary Examiner(s): Tyler, Cheryl
• Assistant Examiner(s): Solak, Timothy P.
• Application Number:
  US10/313,251
• Publication Number:
  US 20030065249A1
• Time in Patent Office: 998 Days
• Field of Search: 417/278, 417/297, 417/441, 417/572, 251/282, 137/512, 137/78.1, 604/891.1, 604/892.1, 604/8, 604/153, 604/288.3
• US Class Current: 417/278
• 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. An inflation inhibitor for an implantable prosthesis, comprising:

a housing in communication with an attached pump bulb;

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

a first flow valve controlling the inlet of the fluid passageway and 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 flow of fluid from the inlet to the outlet in response to a fluid pressure increase within at least a portion of the housing adjacent to the inlet of the fluid passageway that exceeds a predetermined level.

2. The inflation inhibitor of claim 1 wherein fluid pressure controls the outlet sealing mechanism.

3. The inflation inhibitor 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 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.

5. The pump assembly of claim 4, 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.

6. An inflation inhibitor 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 flow of fluid from the inlet to the outlet in response to a fluid pressure increase within at least a portion of the housing that exceeds a predetermined level, 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.

7. The inflation inhibitor of claim 6, 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.

8. The inflation inhibitor of claim 7 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.

9. The inflation inhibitor of claim 8, further comprising a second flow valve disposed within the fluid passageway, between the inlet and the first flow valve.

10. The pump assembly of claim 6, 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.

11. The pump assembly of claim 10 wherein the diaphragm is caused to move to the second position when fluid pressure within the chamber exceeds a predetermined level.

12. The pump assembly of claim 10 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.

13. The pump assembly of claim 6 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.

14. 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, 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.

15. The pressure lock out of claim 14, 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.

16. The pressure lock out of claim 14 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.

17. The pressure lock out of claim 14 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.

18. An inflation inhibitor for an inflatable prosthesis 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, 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.

19. The inflation inhibitor of claim 18 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.

20. The pump and valve assembly of claim 18, 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.

21. The pump and valve assembly of claim 18 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.

22. An inflation inhibitor for an implantable prosthesis, comprising:

a housing having a fluid passage way, 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 increase within the expansion chamber that exceeds a predetermined level, 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.

23. An inflation inhibitor 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 within the housing 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 increase within the expansion chamber that exceeds a predetermined level.

24. The pump assembly of claim 23 wherein the flexible member is a diaphragm that selectively seals the outlet.

25. The pump assembly of claim 23, 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.

26. The pump assembly of claim 25 wherein the second check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve.

27. The pump assembly of claim 23, 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.

28. The pump assembly of claim 27 wherein the second check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve.

29. The pump assembly of claim 23, 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.

30. The pump assembly of claim 29 wherein the first check valve has a first cracking pressure that is lower than a second cracking pressure of the second flow valve.

31. The pump assembly of claim 23, 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.

32. The pump assembly of claim 31 wherein the first fluid resistor passes a higher volume of fluid per unit time than the second fluid resistor.

33. The pump assembly of claim 31 wherein the second fluid resistor is located between the expansion chamber and the intermediate passageway.