Splittable medical valve

• US 20010049499A1
• Filed: 12/28/2000
• Published: 12/06/2001
• Est. Priority Date: 12/30/1999
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Vascular TM Incorporated
• Inventors: Boyle, William J., Lui, Chun Kee
• Granted Patent: US 6,712,791 B2
• Time in Patent Office: Days
• US Class Current: 604/164.05
• CPC Class Codes: A61B 2017/3466 for simultaneous sealing of multiple instruments
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A splittable medical valve is disclosed that is configured with a interfacing region that permits the valve to be placed over or inside of a tubular medical device, such as a splittable introducer sheath, to prevent loss of bodily fluids and/or reduce ingress of air-borne pathogens. The valve further includes a sealing element configured to accept passage of a medical device, such as a catheter, sheath, pacemaker lead, or other ancillary device therethrough, whereby the valve body is split along one or more lines or fissure to allow removal of the valve from around the ancillary device.

Claims

1. A splittable valve assembly comprising:

a hemostatic valve comprising a valve body and a passageway extending therethrough, the valve body including a wall having at least one line of fissure configured such that the hemostatic valve can be split at least partially open to expose the passageway, thereby allowing removal of a first medical device when situated therein; and

at least one sealing element traversing the passageway;

wherein the valve body further includes an interfacing region, the interfacing region configured such that the hemostatic valve is attachable to a separate second medical device, thereby at least substantially eliminating or preventing fluid loss therefrom.

2. The splittable valve assembly of

claim 1

wherein the valve body comprises a non-rigid, elastomeric material.

3. The splittable valve assembly of

claim 2

wherein at least one of the at least one sealing element is integral with the wall of the valve body.

4. The splittable valve assembly of

claim 3

wherein the at least one sealing element includes a proximal seal and a distal seal.

5. The splittable valve assembly of

claim 4

wherein at least one of the at least one sealing element comprises a valve insert, the valve insert being a separate component from the valve body.

6. The splittable valve assembly of

claim 5

wherein the valve insert comprises a foam material.

7. The splittable valve assembly of

claim 2

wherein there are two opposing lines of fissure that longitudinally define a first valve half and a second valve half.

8. The splittable valve assembly of

claim 7

wherein the first half valve half and the second valve half each include an integral tab adapted for grasping and separating the first and second valve halves.

9. The splittable valve assembly of

claim 2

further including a splittable introducer sheath, wherein the hemostatic valve and splittable introducer sheath are each configured such that when the hemostatic valve is removed from the proximal end of the splittable introducer to allow the splittable introducer sheath to partially split along the length thereof, thereby forming a new, second proximal end, the hemostatic valve can be placed over the second proximal end to at least substantially eliminate fluid loss therefrom.

10. The splittable valve assembly of

claim 2

wherein the interfacing region is configured for placement within the passageway of a splittable introducer sheath.

11. The splittable valve assembly of

claim 2

wherein the non-rigid, elastomeric material includes silicone.

12. The splittable valve assembly of

claim 2

further including an outer sheath made of a non-rigid material, the outer sheath having an inner surface and at least one predetermined split line, the outer sheath circumferentially enclosing at least a portion of the length of the hemostatic valve.

13. The splittable valve assembly of

claim 12

, wherein the outer sheath provides an enclosure along a substantial portion of the length of the hemostatic valve.

14. The splittable valve assembly of

claim 13

wherein the outer sheath extends distally from the hemostatic valve to comprise an introducer extension, the at least one predetermined split line substantially extending therealong the length of the introducer sheath.

15. The splittable valve assembly of

claim 14

, wherein the material of the outer sheath comprises a polymer having anisotropic properties to facilitate tearing the outer sheath along the at least one predetermined split line.

16. The splittable valve assembly of

claim 14

, wherein the at least one predetermined split line comprises a preweakened feature.

17. The splittable valve assembly of

claim 12

wherein the lines of fissure extend completely through the walls of the hemostatic valve such that the first and second valve halves are separate components being held together by the radially constraining forces of the outer sheath.

18. The splittable valve assembly of

claim 12

wherein the first valve half is affixed to the outer sheath at a first attachment point and the second valve half is attached to the outer sheath at a second attachment point, the first and second attachment points being separated by at least one of the predetermined split line such that the splitting of the outer sheath results in the first and second valve halves being forced apart, while each remaining affixed to the outer sheath.

19. The splittable valve assembly of

claim 2

wherein the hemostatic valve further includes a proximal locking chamber configured to accept a proximal hub of a dilator to at least temporarily secure the hub therein, thereby preventing movement of the dilator relative to the hemostatic valve.

20. The splittable valve assembly of

claim 2

wherein the interfacing region includes a plurality of steps, each of the plurality of steps sized for placement over a different-diameter tubular medical conduit.

21. The splittable valve assembly of

claim 1

further including a valvular cavity, the valvular cavity at least partially filled will a sealant filler material.

22. The splittable valve assembly of

claim 1

comprising a plurality of proximal seals that include at least a first seal communicating with a first sub-passageway and a second proximal seal communicating with a second sub-passageway, the first and second sub-passageways uniting at a bifurcation point located within the passageway of the valve body.

23. The splittable valve assembly of

claim 1

wherein the valve body substantially comprises a rigid polymeric material.

24. The splittable valve assembly of

claim 1

wherein at least one sealing element comprises a tulip-shaped valve having a plurality of valve leaflets, the splittable valve assembly further including at least one biasing mechanism positioned within the passageway so as to urge the plurality of valve leaflets into a closed position.

25. The splittable valve assembly of

claim 24

wherein the biasing mechanism include a first and a second biasing member oppositely placed within the passageway to urge the plurality of leaflets closed.

26. The splittable valve assembly of

claim 24

wherein the biasing mechanism includes a annular ring located within the passageway such that it surrounds the tulip-shaped valve and urges the plurality of leaflets closed.

27. The splittable valve assembly of

claim 1

wherein the interfacing region is so configured such that the splittable valve assembly can be detached and reattached to the second medical device.

28. A splittable valve assembly comprising:

a hemostatic valve comprising a valve body made of a non-rigid, elastomeric material and a passageway extending therethrough, the valve body including a wall having two opposing lines of fissure that longitudinally define a first valve half and a second valve half such that the hemostatic valve can be split open along the lines of fissure in order to remove the hemostatic valve from around a first medical device when situated therein; and

at least one sealing element traversing the passageway, at least one of the sealing elements being integral with the valve body;

wherein the valve body further includes an interfacing region, the interfacing region configured such that the hemostatic valve is attachable over the proximal end of an separate second medical device during a medical procedure, thereby substantially eliminating or preventing fluid loss therefrom, the hemostatic valve also being removable and reattachable to the second medical device.

29. The splittable valve assembly of

claim 28

wherein at least one of the at least one sealing element is integral with the wall of the valve body.

30. The splittable valve assembly of

claim 29

wherein the at least one sealing element includes a proximal seal and a distal seal.

31. The splittable valve assembly of

claim 30

wherein at least one of the proximal seal comprises a valve insert at least substantially made of a foam material, the valve insert being separate component from the valve body.

32. The splittable valve assembly of

claim 28

wherein the first half valve half and the second valve half each include an integral tab located at the proximal end of the splittable valve assembly, the integral tabs adapted for grasping and separating the first and second valve halves.

33. The splittable valve assembly of

claim 28

further including a splittable introducer sheath, wherein the hemostatic valve and splittable introducer sheath are each configured such that when the hemostatic valve is removed from the proximal end of the splittable introducer to allow the splittable introducer sheath to partially split along the length thereof, thereby forming a new, second proximal end, the hemostatic valve can be placed over the second proximal end to at least substantially eliminate fluid loss therefrom.

34. A splittable valve assembly comprising:

a hemostatic valve comprising a valve body and a passageway extending therethrough, the valve body including a wall having at least one line of fissure configured such that the hemostatic valve can be split at least partially open to expose the passageway, thereby allowing removal of a first medical device situated therein;

at least one sealing element traversing the passageway; and

a splittable introducer sheath comprising a anisotropic polymeric material and having a passageway therethrough;

wherein the hemostatic valve is situated at least partially within the passageway of the splittable introducer sheath.

35. A splittable valve assembly comprising:

a hemostatic valve comprising a valve body made of a silastic material and a passageway extending therethrough, the valve body including a wall having two opposing lines of fissure that longitudinally define a first valve half and a second valve half such that the hemostatic valve can be split open along the lines of fissure in order to remove the hemostatic valve from around an first medical device when situated therein, each valve half including a grasping element comprising an integral tab;

a proximal receiving chamber configured to accept a proximal hub of a dilator to at least temporarily secure the hub therein, thereby preventing movement of the dilator relative to the hemostatic valve; and

a plurality of sealing elements traversing the passageway that include a distal seal that is integral with the valve body, and a proximal seal comprising a valve insert, the valve insert comprising a foam material and including an aperture therethough;

wherein the valve body further includes an interfacing region, the interfacing region configured such that the hemostatic valve may be placed over the proximal end of an introducer sheath, thereby substantially eliminating or preventing fluid loss therefrom, the interfacing region further comprising a plurality of steps, each of the plurality of steps sized for placement over a different-diameter splittable introducer sheath.