Vascular introducer sheath and hemostasis valve for use therewith

• US 6,322,541 B2
• Filed: 09/10/1999
• Issued: 11/27/2001
• Est. Priority Date: 09/10/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: West, Ronald L., Van Diver, Mark H.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/393,865
• Publication Number:
  US 20010001813A1
• Time in Patent Office: 809 Days
• Field of Search: 604/167-1-1, 604/246-247, 604/256, 604/523, 251/149.1, 137/844-845, 137/859
• 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 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: Y10T 137/788 Having expansible port

Abstract

A vascular introducer sheath including a tubular shaft and a hemostasis valve assembly connected to the proximal end thereof. The hemostasis valve assembly includes a hub, a cap and a normally-flat gasket disposed therebetween. Both the hub and the cap include continuous curved contact surfaces facing the top and bottom surfaces of the gasket. The continuous contact surfaces may be flat or gently curved and may be smooth or include a means to grip the gasket. At least one of the contact surfaces is formed at an angle to cause the gasket to become convex or concave in response to compression between the hub and the cap. The continuous contact surfaces uniformly distribute forces onto the perimeter of the gasket to avoid stress concentration points that may compromise gasket integrity. In addition, the continuous contact surfaces reduce the amount of pressure necessary to impart the curved shape of the gasket.

Claims

1. A vascular introducer sheath for use with a vascular access system, the vascular introducer sheath comprising:

a tubular shaft having a proximal end and a distal end; and

a hemostasis valve assembly connected to the proximal end of the tubular shaft, the hemostasis valve assembly including a hub having a longitudinal axis and a continuous contact surface, a cap having a continuous contact surface, and a gasket disposed therebetween defining a contact area with the hub and the cap, wherein at least one of the contact surfaces forms a non-orthogonal angle with longitudinal axis to cause the gasket to become curved in response to compression between the hub and the cap and wherein the continuous contact surface of the hub and the continuous contact surface of the cap have parallel contact anglesin cross-section which are the same throughout the contact area of the gasket with the hub and the cap to uniformly distribute forces onto the gasket and to avoid stress concentration points.

2. A vascular introducer sheath as in claim 1, wherein both contact surfaces form a non-orthogonal angle with longitudinal axis to cause the gasket to become curved in response to compression between the hub and the cap.

3. A vascular introducer sheath as in claim 2, wherein the non-orthogonal angle is acute.

4. A vascular introducer sheath as in claim 3, wherein a top surface of the gasket is convex.

5. A vascular introducer sheath as in claim 2, wherein the non-orthogonal angle is obtuse.

6. A vascular introducer sheath as in claim 5, wherein a top surface of the gasket is concave.

7. A vascular introducer sheath as in claim 1, wherein the gasket is normally-flat.

8. A vascular introducer sheath as in claim 7, wherein the gasket has at least one slit extending therethrough, the slit being normally-closed when the gasket is flat.

9. A vascular introducer sheath as in claim 1, wherein at least one of the contact surfaces includes a means to retain the gasket between the hub and cap.

10. A vascular introducer sheath as in claim 9, wherein the retaining means comprises an orthogonal flat surface.

11. A vascular introducer sheath as in claim 1, wherein the continuous contact surface of the hub and the continuous contact surface of the cap are flat.

12. A vascular introducer sheath as in claim 1, wherein the continuous contact surface of the hub and the continuous contact surface of the cap are gently curved.

13. A hemostasis valve assembly for use with a vascular introducer sheath, the hemostasis valve assembly comprising:

a hub having a continuous contact surface and a longitudinal axis;

a cap co-axially disposed about the hub, the cap having a continuous contact surface; and

a gasket disposed between the hub and cap defining a contact area with the hub and the cap, the gasket having a top surface and a bottom surface, the top surface disposed adjacent the contact surface of the cap and the bottom surface disposed adjacent the contact surface of the hub, wherein the contact surface of the hub forms a non-orthogonal angle with longitudinal axis to cause the gasket to become curved in response to compression between the hub and the cap, and wherein the continuous contact surface of the hub and the continuous contact surface of the cap have parallel contact angles in cross-section which are the same throughout the contact area of the gasket with the hub and the cap to uniformly distribute forces onto the gasket and to avoid stress concentration points.

14. A hemostasis valve assembly as in claim 13, wherein the gasket is normally-flat.

15. A hemostasis valve assembly as in claim 14, wherein the gasket has at least one slit extending from the top surface to the bottom surface, the at least one slit being normally-closed at both the top and bottom surfaces when the gasket is flat.

16. A vascular introducer sheath as in claim 13, wherein at least one of the contact surfaces includes a means to retain the gasket between the hub and cap.

17. A vascular introducer sheath as in claim 16, wherein the retaining means comprises an orthogonal flat surface.

18. A hemostasis valve assembly as in claim 13, wherein the continuous contact surface of the hub and the continuous contact surface of the a are flat.

19. A hemostasis valve assembly as in claim 13, wherein the continuous contact surface of the hub and the continuous contact surface of the cap are gently curved.

20. A hemostasis valve assembly as in claim 13, wherein the contact surface of the hub forms an acute angle with longitudinal axis to cause the top surface of the gasket to become convex in response to compression between the hub and the cap.

21. A hemostasis valve assembly as in claim 13, wherein the contact surface of the hub forms an obtuse angle with longitudinal axis to cause the top surface of the gasket to become concave in response to compression between the hub and the cap.

22. A hemostasis valve assembly as in claim 13, wherein both contact surfaces form a non-orthogonal angle with longitudinal axis to cause the gasket to become curved in response to compression between the hub and the cap.