Hemostasis valve with catheter/guidewire seals

• US 5,935,112 A
• Filed: 10/15/1997
• Issued: 08/10/1999
• Est. Priority Date: 10/15/1997
• Status: Expired due to Term

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Stevens, Brian W., Nelson, Arlin Dale
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/950,627
• Time in Patent Office: 664 Days
• Field of Search: 604/167, 604/245, 604/246, 604/247, 604/248, 604/256, 604/164, 604/169, 604/283
• 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 2039/066 Septum-like element
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A hemostasis valve which includes a tubular body having a lumen therethrough and an elongated housing attached to the tubular body. The body has a recess formed in one end. The housing has a longitudinal bore at one end and a compression chamber formed at another end which communicates with the bore. A resilient seal which comprises a cone-shaped membrane portion disposed in the recess for substantially blocking and controlling the loss of body fluids from the lumen. A compressible second seal for selectively opening and closing the bore in response to a compressive force is disposed in the compression chamber. The compressible seal has a longitudinal first passageway that communicates with the bore and a raised annular portion which serves as a selective opening to the bore. The compressible seal responds to compressive forces so as to reduce or increase the size of the opening provided by the raised annular portion to selectively seal or unseal the bore. The hemostasis valve includes a rotatable end cap configured to exert a compressive force on the compressible seal when rotated in one direction relative to the housing, and releases the compressive force when rotated in an opposite direction. The compressible seal is configured to allow an instrument accessing the lumen to be repositioned or removed while maintaining an adequate seal capable of preventing substantially all loss of the body fluids beyond the compressible seal without the user having to rotate the end cap to release the compressive force acting on the compressible seal.

Claims

1. A valve apparatus comprising:

(a) body means for providing a lumen therethrough and which is adapted for accessing the cardiovascular or other intravenous system of a patient;

(b) housing means, attached to said body means, for providing a longitudinal bore therethrough in communication with said lumen, said housing means including a compression chamber;

(c) resilient first sealing means, disposed in said body means, for substantially blocking and controlling the loss of body fluids from said lumen, said first sealing means comprising a body portion having an interior surface and a cone-shaped membrane portion attached to said interior surface of said body portion;

(d) resiliently deformable second sealing means, disposed within said compression chamber, for selectively sealing and unsealing said longitudinal bore in response to a compressive force exerted on said second sealing means, said second sealing means including a longitudinal passageway therethrough which communicates with said longitudinal bore and provides an opening thereto, said second sealing means assuming a normally open position when not subjected to said compressive force, said second sealing means responding to said compressive force so as to selectively and progressively reduce the size of said opening; and

(e) compressing means attached to said housing means for selectively increasing and decreasing said compressive force on said second sealing means.

2. A valve apparatus recited in claim 1, when said compressing means is rotatable such that said compressive force can be increased when said compressing means is rotated in one direction relative to said housing means and such that said compressive force can be decreased when said compressing means is rotated in an opposite direction relative to said housing means.

3. A valve apparatus as recited in claim 2, further comprising second holding means for interlocking a proximal end of said second sealing means such that when said rotatable compressing means is rotated relative to said body means said proximal end of said second sealing means is substantially prevented from rotating.

4. A valve apparatus as recited in claim 3, wherein said second holding means comprises:

(f) a ridge projecting from a proximal end of said compressing means and defining a retaining groove positioned between said ridge and an outer perimeter of said compression chamber; and

(g) a tongue proximally projecting from said proximal end of said second sealing means and received within said retaining groove.

5. A valve apparatus as recited in claim 2, further comprising slip ring means, disposed between said second sealing means and said rotatable compressing means, for reducing rotational biasing between said compressing means and said second sealing means upon rotating said compressing means relative to said second sealing means.

6. A valve apparatus as recited in claim 5, wherein said slip ring means comprises a slip ring positioned between said second seal means and said compressing means, said slip ring comprising:

(a) a first ring portion configured to be received within a corresponding recess at a proximal end of said second sealing means; and

(b) a second ring portion secured proximal to said first ring portion and configured to cooperate with said compressing means.

7. A valve apparatus as recited in claim 2, wherein said rotatable compressing means comprises a shaft and means for engaging said shaft and said second sealing means by selectively advancing said shaft into said compression chamber, and said coupling means comprising:

(a) first engagement threads positioned at a proximal end of said housing means; and

(b) second engagement threads positioned at a distal end of said rotatable compressing means, said second engagement threads being configured for threadably engaging said first engagement threads once said shaft is partially received within said compression chamber.

8. A valve apparatus recited in claim 1, wherein said first sealing means comprises a membrane portion with an aperture formed therein.

9. A valve apparatus as recited in claim 1, wherein said membrane portion comprises a material selected from the group consisting of silicon rubber and elastomer materials.

10. A valve apparatus as recited in claim 1, wherein said second sealing means comprises a compressible seal having an interior surface defining said longitudinal passageway and having a raised annular portion protecting into said longitudinal passageway.

11. A valve apparatus as recited in claim 10, wherein said compressible seal has an outer surface that is substantially cylindrical-shaped so as to correspond to a substantially cylindrical-shaped compression chamber.

12. A valve apparatus as recited in claim 10, wherein said raised annular portion of said compressible seal comprises an annular rib.

13. A valve apparatus as recited in claim 10, wherein said raised annular portion of said compressible seal comprises a fin.

14. A valve apparatus as recited in claim 10, wherein said compressible seal has a substantially hour-glass shaped configuration when in a substantially uncompressed state.

15. A valve apparatus as recited in claim 10, wherein said interior surface of said compressible seal is substantially hour-glass shaped, wherein said raised annular portion comprises a raised central peak located at a narrowest point of said longitudinal passageway formed by said hour-glass shaped interior surface.

16. A valve apparatus as recited in claim 1 further comprising holding means for interlocking a distal end of said second scaling means within said housing means such that when said compressive force is exerted on said second sealing means the distal end of said second sealing means is prevented from entering said longitudinal bore of said housing means.

17. A valve apparatus as recited in claim 16, wherein said holding means comprises:

(a) a ridge projecting into said compression chamber toward a proximal end of said housing means, said ridge defining a retaining groove positioned between said ridge and an outer perimeter of said compression chamber; and

(b) a tongue distally projecting from said distal end of said sealing means and received within said retaining groove.

18. A valve apparatus as recited in claim 17, wherein said ridge is annular and encircles said longitudinal bore so that said retaining groove is annular, wherein said tongue is annular so that it correspondingly mates with said retaining groove.

19. A valve apparatus comprising:

(a) body means for providing a lumen therethrough and which is adapted for accessing the cardiovascular or other intravenous system of a patent, said body means including an interior recess;

(b) housing means, attached to said body means, for providing a longitudinal bore therethrough in communication with said lumen, said housing means comprising a hollow compression chamber;

(c) resilient sealing means, at least a portion of which is disposed within said recess of said body means, for substantially blocking and controlling the loss of body fluids from said lumen, said sealing means comprising a generally cone-shaped membrane portion having an apex and an aperture formed through said apex;

(d) a resiliently deformable compressible seal disposed within said compression chamber for selectively sealing and unsealing said longitudinal bore in response to a compressive force exerted on said compressible seal, said compressible seal having a longitudinal passageway therethrough which communicates with said longitudinal bore of said housing means and provides an opening thereto, said longitudinal passageway of said compressible seal having a raised annular portion formed therein, said elongated compressible seal assuming, a normally open position when not subjected to said compressive force, said compressible seal responding to said compressive forces so as to selectively and progressively reduce the size of said opening provided by said passageway; and

(e) compressing means, rotatably attached to said housing means, for selectively increasing said compressive force on said compressible seal when said compressing means is rotated in one direction relative to said housing means and for selectively decreasing said compressive force on said seal when said compressing means is rotated in an opposite direction relative to said housing means, said compressing means comprising an elongated shaft means for contacting a proximal and of said compressible seal so as to exert said compressive force on said compressible seal,

wherein said raised annular portion formed in said passageway of said compressible seal is configured to allow an instrument accessing said lumen to be repositioned or removed while maintaining a seal capable of preventing substantially all loss of body fluids beyond said compressible seal without rotating said compressing means to release substantially all of said compressive force acting on said compressible seal.

20. A valve apparatus as recited in claim 19, further comprising slip ring means, disposed between said compressible seal and said compressing means, for reducing rotational biasing between said compressing means and said compressible seal upon rotating said compressing means relative to said compressible seal.

21. A valve apparatus as recited in claim 19, wherein said raised annular portion of said compressible seal comprises an annular rib.

22. A valve apparatus as recited in claim 19, further comprising a compressible sealing means, disposed adjacent said compressible seal, for selectively sealing and unsealing said longitudinal bore in said housing means in combination with said compressible seal, said compressible sealing means and said compressible seal comprising varying materials, respectively, having different durometer readings, thereby causing said compressible sealing means and said compressible seal to form a seal at varying rates in response to application of said compressive force.

23. A valve apparatus as recited in claim 22, wherein said compressible sealing means comprises a second compressible seal having a second longitudinal passageway formed therethrough and a raised annular portion that projects into said second longitudinal passageway.

24. A valve apparatus comprising:

(a) a generally elongated tubular body having a lumen formed therethrough which is adapted for accessing the cardiovascular or other intravenous system of a patient, said tubular body including an interior recess in communication with said lumen and located adjacent a proximal end of said tubular body;

(b) an elongated housing attached to said proximal end of said tubular body and including a longitudinal bore formed therethrough, said housing having an interior hollow compression chamber formed in the proximal end thereof and in communication with said longitudinal bore;

(c) a resilient seal including a resilient cone-shaped membrane portion capable of substantially blocking the loss of body fluids from said lumen, said membrane portion having an aperture formed at an apex thereof;

(d) a resilient compressible seal substantially disposed within said compression chamber and including a longitudinal passageway formed therethrough aligned and in communication with said longitudinal bore and a raised annular ridge projecting into said passageway, said raised annular ridge selectively providing an opening to said longitudinal bore, said compressible seal assuming a normally open position when not subjected to said compressive force, said compressible seal being configured to selectively seal and unseal said bore in response to a compressive force exerted on said compressible seal by selectively and progressively reducing and increasing the size of said opening provided by said annular ridge, said annular ridge being capable of forming a seal around an instrument disposed therein sufficient to substantially prevent any body fluids that may pass through said aperture of said cone-shaped membrane portion from passing through said longitudinal passageway while being adjustable to allow for longitudinal movement and adjustment of said instrument; and

(e) a rotatable end cap attached to said housing and having a shaft integrally formed therewith, said shaft projecting from said end cap and being configured to partially fit within said compression chamber of said housing in order to selectively compress said compressible seal when said shaft is advanced within said compression chamber by rotation of said end cap.

25. A valve apparatus as recited in claim 24, further comprising a second compressible seal disposed between said compressible seal and said shaft of said rotatable end cap, said second compressible seal having a second longitudinal passageway formed therethrough in communication with said longitudinal passageway of said compressible seal said compressible seal and said second compressible seal having different hardnesses such that each responds to said compressive force at differing rates.

26. A valve apparatus as recited in claim 24 further comprising:

(a) a supplemental access tube having a central bore formed therethrough in fluid communication with said lumen in said tubular body, said supplemental access tube including a compression chamber formed in a remote end thereof and being in communication with said central bore;

(b) a resilient deformable auxiliary sealing means, substantially disposed within said compression chamber of said supplemental access tube for selectively sealing and unsealing said central bore in response to an auxiliary compressive force exerted on said auxiliary sealing means, said auxiliary sealing means including a longitudinal passageway therethrough which communicates with said central bore in said supplemental access tube and which provides an opening thereto, said auxiliary sealing means assuming a normally open position when not subjected to said auxiliary compressive force, said sealing means responding to said auxiliary compressive force so as to selectively and progressively reduce the size of said opening provided by said central bore; and

(c) auxiliary compressing means, rotatably attached to a remote end of said supplemental access tube, for selectively increasing said auxiliary compressive force on said auxiliary sealing means when said auxiliary compressing means is rotated in one direction relative to said supplemental access tube, and for selectively decreasing said auxiliary compressive force on said auxiliary sealing means when said auxiliary compressing means is rotated in an opposite direction relative to said supplemental access tube.