Pressure based spontaneous inflation inhibitor with penile pump improvements

• US 6,730,017 B2
• Filed: 12/03/2001
• Issued: 05/04/2004
• 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: Waldack, Larry E., Henkel, Gregory J., Kuyava, Charles C., Morningstar, Randy L., Almli, John G.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/010,498
• Publication Number:
  US 20020082473A1
• Time in Patent Office: 883 Days
• Field of Search: 600/38-41, 600/29-32, 128/171, 128/625, 128/843, 623/11.11
• US Class Current: 600/40
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: Y10T 137/0379 By fluid pressure

Abstract

A pump assembly for a penile implant is provided having a mechanism which prevents spontaneous inflation of the cylinders implanted within the patient. The pump assembly has an actuating bar with ribs to enhance the spring force applied to a flow valve, a support structure to support and appropriately position the actuating bar, and a check valve made of metal with a segment covered with a plastic material. The preventative mechanism uses overpressure generated by the reservoir during unintentional compression to effectively seal the cylinders 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 penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to couple to a reservoir;

a fluid outlet from the housing, the fluid outlet being adapted to couple to an inflatable cylinder;

a fluid passageway coupling the inlet to the outlet;

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 reservoir chamber coupling the inlet to the fluid passageway, wherein a portion of the first check valve extends into the reservoir chamber and is coupled to an outer wall of the reservoir chamber so that as fluid pressure within the reservoir chamber increases, an expansion of the reservoir chamber occurs which urges the first check valve towards a closed position.

2. The prosthesis of claim 1 wherein a negative pressure generated by an expansion of the pump bulb is sufficient to open the first check valve.

3. The prosthesis of claim 1 further including a spring coupling the first check valve to the outer wall.

4. The prosthesis of claim 1 wherein the spring biases the first check valve toward the closed position so that as the fluid pressure increases in the reservoir chamber, the biasing of the spring will aid in resisting the unintentional unseating of the first check valve.

5. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to couple to a reservoir;

a fluid outlet from the housing, the fluid inlet being adapted to couple 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;

a spring biasing the first check valve into the sealed position, wherein the biasing force of the spring is selected to be strong enough to oppose pressures generated in an overpressurization situation and keep the first check valve in the sealed position; and

a face coupled to the first check valve wherein the face has a large diameter compared to a diameter of the remainder of the first check valve so that suction forces generated after a compression of a pump bulb act on a sufficient surface area of the face to overcome the biasing force of the spring.

6. The pump assembly of claim 5 further including:

a first lip seal located within the housing for selectively engaging an inner diameter portion of the face in a substantially fluid tight manner; and

a second lip seal located within the housing for selectively engaging an outer diameter portion of the face in a substantially fluid tight manner.

7. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to be coupled to a reservoir;

a fluid outlet from the housing, the fluid outlet being adapted to be coupled 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;

a front face on the first check valve for selectively sealing and unsealing an opening to the fluid inlet;

a rear section protruding from the first check valve away from the opening, including an internal fluid passageway and a throughbore providing access into the internal fluid passageway and an outlet providing an egress from the internal fluid passageway; and

a valve sleeve slidably engaging the rear section to selectively seal and unseal the throughbore so that as higher pressure levels are generated within the inlet, front face of the first check valve is caused to unseal the opening and the valve sleeve is caused to seal the throughbore, wherein the valve sleeve contacts a portion of the housing and prevents fluid flow to the outlet.

8. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to couple to a reservoir;

a fluid outlet from the housing, the fluid outlet being adapted to couple 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 second check valve disposed within the fluid passageway and biased towards a closed position;

a first check valve disposed within the fluid passageway and biased towards a closed position, the first check valve having a front face for selectively sealing and unsealing an opening to the fluid inlet and a rear stem section protruding from the first check valve away from the opening, including a cylindrical portion and a groove;

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

a conical lip seal integral with the housing and positioned so that the rear stem section is moveable therein so that when a cylindrical portion of the stem section is aligned with the conical lip seal, fluid flow in a direction from the inlet to the outlet is prevented and increased pressure levels within the inlet serves to further seal the conical lip seal against the cylindrical portion of the stem section, and when the groove is aligned with the conical lip seal, fluid flow is permitted; and

an annulus integral with the housing positioned so as to cooperate with the front face, allowing the front face to be forcibly move therethrough so that when the front face is on a first side of the annulus, the groove of the stem section is aligned with the conical lip seal and when the front face is on a second side of the annulus the cylindrical portion of the stem is aligned with the conical lip seal.

9. The penile prosthesis of claim 8, further comprising:

a spacer separating a rear portion of the front face from the annulus when said front face is on said first side so that fluid flow is permitted around the rear portion and through the annulus.

10. The penile prosthesis of claim 9 wherein the spacer is a plurality of bumps located on the annulus.

11. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to couple to a reservoir;

a fluid outlet from the housing, the fluid outlet being adapted to couple to an inflatable cylinder;

a fluid passageway coupling the inlet to the outlet, the fluid passageway having a major axis;

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, wherein a negative pressure generated by an expansion of the pump bulb is sufficient to open the first check valve; and

a reservoir chamber coupling the inlet to the fluid passageway, wherein a portion of the first check valve extends into the reservoir chamber and is coupled to an outer wall of the reservoir chamber so that as fluid pressure within the reservoir chamber increases, an expansion of the reservoir chamber occurs which urges the first check valve towards a closed position.

12. The prosthesis of claim 11 further including:

a bar positioned within the housing and moveable between a first and a second position so that when the bar is moved from the first position to the second position the bar causes the first check valve to move from a closed position to an open position to deflate the implantable prosthesis, wherein the bar comprises a spring;

a support member coupled to the housing and mechanically linked to the first check valve to prevent transverse movement of first check valve relative to the major axis of the fluid passageway when the first check valve is moving from an open to a closed position; and

the first check valve is made of a metallic material with a plastic member disposed over a portion of the first check valve.

13. The prosthesis of claim 11 further including:

a spring coupling the first check valve to the outer wall;

the bar further comprising at least one rib extending across a bend such that a spring is created to afford the movement of the first check valve from a closed to an open position for deflation of the prosthesis.

14. The prosthesis of claim 11 wherein the spring is biased to maintain the first check valve in close proximity to the outer wall, and the biasing of the spring affording the intentional unseating of the first check valve after a pump bulb compression.

15. A penile prosthesis comprising:

a housing;

a fluid inlet to the housing, the fluid inlet being adapted to couple to a reservoir;

a fluid outlet from the housing, the fluid outlet being adapted to couple to an inflatable cylinder;

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

a fluid passageway with a major axis, the fluid passageway being fluidly coupled to the reservoir chamber;

a first check valve disposed within the fluid passageway and biased towards a closed position, the first check valve made of a metallic material with a plastic member disposed over a portion of the first check valve;

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 bar positioned within the housing and moveable between a first and a second position so that when the bar is moved from the first position to the second position the bar causes the first check valve to move from a closed position to an open position to deflate the implantable prosthesis, wherein the bar comprises a spring;

a support member coupled to the housing and mechanically linked to the first check valve to prevent transverse movement of first check valve relative to the major axis of the fluid passageway when the first check valve is moving from an open to a closed position,

a spring biasing the first check valve into a sealed position, wherein the biasing force of the spring is selected to be strong enough to oppose pressures generated in an overpressurization situation and keep the first check valve in the sealed position; and

a face coupled to the first check valve wherein the face has a large diameter compared to a diameter of the remainder of the first check valve so that suction forces generated after a compression of a pump bulb act on a sufficient surface area of the face to overcome the biasing force of the spring.

16. The prosthesis of claim 15 further including:

a first lip seal located within the housing for selectively engaging an inner diameter portion of the face in a substantially fluid tight manner; and

a second lip seal located within the housing for selectively engaging an outer diameter portion of the face in a substantially fluid tight manner.