Hemostatis valve

• US 5,000,745 A
• Filed: 11/18/1988
• Issued: 03/19/1991
• Est. Priority Date: 11/18/1988
• Status: Expired due to Fees

• Current Assignee: Henley Operating Company
• Original Assignee: Edward Weck Incorporated
• Inventors: Withers, Alexander S., Guest, Robert L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Gutowski, A.
• Application Number:
  US07/273,282
• Time in Patent Office: 851 Days
• Field of Search: 604/167, 604/169, 604/256, 604/247, 604/201, 604/905, 604/244, 251/149.1, 137/845, 137/843, 137/849, 277/207 A, 277/217, 277/212 C
• US Class Current: 604/256
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An introducer sheath assembly having an improved valve assembly including at least three elastic disc shaped membranes. A first membrane has a circular hole through the center to sealingly receive a catheter while a second membrane has a center hole smaller than the hole in the first membrane to sealingly receive a guidewire. The second membrane also has at least one slit through the hole to accommodate passage of the larger catheter through the second membrane. A third membrane contains at least one slit through its center to seal the valve assembly in the absence of a guidewire or catheter.

Claims

1. In a hemostasis valve, the improvement comprising:

a first planar elastic membrane having a circular hole disposed therein;

a second planar elastic membrane having a circular hole with a diameter smaller than said circular hole in said first elastic membrane, said second elastic membrane further comprising at least one slit which intersects said smaller hole, said slit aligned in a single plane extending through said elastic membrane; and

a third planar elastic membrane with no hole having at least one slit therein.

2. The hemostasis valve of claim 1 wherein said holes in said first and second elastic membranes are substantially coaxial.

3. The hemostasis valve of claim 2 wherein said at least one slit in said second elastic membrane lies along a substantially straight line in a first direction and said at least one slit in said third elastic membrane lies along a substantially straight line in a direction transverse to said first line, said slits intersecting the common coaxial center line of said first and second membrane.

4. The hemostasis valve of claim 3 wherein said slit in said second and third elastic membranes are substantially at right angles to one another.

5. The hemostasis valve of claim 3 wherein said valve comprises means for registering said second and third elastic membranes in said assembly whereby said slits are transverse to one another.

6. The hemostasis valve of claim 5 wherein said membranes are circular and said registering mean comprises a pair of spaced apart protruding ears on each of said second and third membranes, said pair of ears or said second membrane aligned with said pair on said third membrane.

7. The hemostasis valve of claim 1 wherein said valve further comprises a washer disposed adjacent to and between said second and third membranes and having an aperture disposed therein which is larger than and overlaps said hole in said second membrane.

8. The hemostasis valve of claim 7 wherein the periphery of said aperture in said washer is conically shaped to accommodate separation of said one slit in said second membrane distally when a catheter is present in said valve assembly

9. A hemostasis valve comprising:

connector means having an inlet end, an opposite outlet end, and a passage through said valve extending from said inlet end to said outlet end;

a plurality of elastic membranes mounted in said passage, said plurality comprising;

a first planar elastic membrane having a circular hole disposed therein;

a second planar elastic membrane having a circular hole with a diameter smaller than said circular hole in said first elastic membrane said second elastic membrane further comprising at least one slit which intersects said smaller hole, said slit aligned in a single plane extending through said elastic membrane; and

a third planar elastic membrane having at least one slit therein.

10. This hemostasis valve of claim 9 wherein said holes in said first and second elastic membranes are substantially coaxial.

11. The hemostasis valve of claim 10 wherein said at least one slit in said second elastic membrane lies along a substantially straight line in a first direction and said at least one slit in said third elastic membrane lies along a substantially straight line in a direction transverse to said first line, said slits intersecting the common coaxial center line of said first and second membranes.

12. The hemostasis valve of claim 11 wherein said slit is said second and third elastic membranes are substantially at right angles to one another.

13. The hemostasis valve of claim 11 wherein said valve comprises means for registering said second and third elastic membranes in said assembly whereby said slits are transverse to one another.

14. The hemostasis valve of claim 9 wherein said connector means comprises a second inlet in fluid communication with said passage.

15. The hemostasis valve of claim 9 wherein said inlet end comprises a coupler means for removably coupling said valve to a separate medical device.

16. The hemostasis valve of claim 15 wherein said coupler means comprises a female luer coupling.

17. The hemostasis valve of claim 9 wherein said outlet end comprises a coupler means for removably coupling said valve to a sheath cannula assembly.

18. The hemostasis valve of claim 17 wherein said coupler means comprises a male luer coupling.

19. The hemostasis valve of claim 9 wherein said valve comprises a flexible cannula fluidly connected to said outlet end.

20. The hemostasis valve of claim 9 wherein said connector means comprises a cap portion having said inlet end for coupling to a body portion having said outlet end, said cap and body portions adapted to compress the peripheral portions of said first, second and third elastic membranes together when said cap and body portions are coupled together, the center portion of said third elastic membrane having said slit being displaced distally from said second elastic membrane by said compression without opening said slit.

21. The hemostasis valve of claim 9 wherein said at least one slit in said second and third membranes comprise Y-shaped slits

22. The hemostasis valve of claim 9 wherein said at least one slit of said second membrane comprises a pair of slits transverse to one another intersecting said hole.

23. The hemostasis valve of claim 22 wherein said at least one slit of said third membrane comprises a pair of slits transverse to one another.

24. The valve of claim 13 wherein said membranes are circular and said registering means comprises a pair of spaced apart protruding ears on each of said second and third membranes, said pair on said second membrane being aligned with said pair on said third membrane;

and said connector means comprising an internal recess to receive said protruding ears.