Hemostasis valve design for introducer sheath

Patent metadata

Field	Value
Publication number	US-11779743-B2
Application number	US-202017063807-A
Country	US
Kind code	B2
Filing date	Oct 6, 2020
Priority date	Nov 9, 2016
Publication date	Oct 10, 2023
Grant date	Oct 10, 2023

Abstract

A hemostasis valve for use in a medical device. The hemostasis valve may include a generally cylindrical body having a proximal side, a distal side, and a thickness extending therebetween. The proximal side may include a tapered central region having a surface sloped towards a center of the body and the distal side may include a distally extending curved central region.

First claim

What is claimed is:

1. A hemostasis valve for use in a medical device, the hemostasis valve comprising:
a body designed to be disposed within a hub of a medical device, the body having a proximal side, a distal side, and a central region defined by a perimeter and having a diametrical center point;
wherein the proximal side of the central region includes a distally extending proximal surface that slopes toward the distal side of the body, wherein an entirety of the distally extending proximal surface that extends between the perimeter of the central region and the diametrical center point of the central region is linear; and
wherein the distal side of the central region includes a distally extending distal surface that extends between the perimeter of the central region and the diametrical center point of the central region, wherein an entirety of the distally extending distal surface in the central region has a shape that is different from a shape of the distally extending proximal surface in the central region.

2. The hemostasis valve of claim 1 , wherein thickness of the body is measured between the proximal side and the distal side, wherein the body has a first thickness at the perimeter of the central region and a second thickness at the diametrical center point, wherein the second thickness is less than the first thickness.

3. The hemostasis valve of claim 2 , wherein the thickness in the central region decreases from the perimeter to the diametrical center point.

4. The hemostasis valve of claim 1 , wherein the shape of the distal surface in the central region is rounded.

5. The hemostasis valve of claim 4 , wherein the shape of the proximal surface in the central region is a pointed cone.

6. The hemostasis valve of claim 1 , wherein the body comprises an elastomeric silicone.

7. The hemostasis valve of claim 1 , wherein the body comprises a liquid silicone rubber (LSR).

8. The hemostasis valve of claim 1 , wherein the body comprises an enhanced tear resistant (ETR) silicone elastomer.

9. The hemostasis valve of claim 1 , further comprising one or more slits formed in the body and extending at least partially through a thickness of the body in the central region.

10. The hemostasis valve of claim 9 , wherein the one or more slits are formed in a cross slit thru (CST) configuration.

11. The hemostasis valve of claim 9 , wherein the one or more slits are formed in a star slit thru (SST) configuration.

12. The hemostasis valve of claim 9 , including at least a first slit and a second slit, wherein the first and second slits are formed in cross slit partial (CSP) configuration, with the first slit formed in the proximal side and extending distally only partially through the body and the second slit formed in the distal side and extending proximally only partially through the body, wherein the first and second slits meet between the proximal and distal sides at an intersection point defining an opening extending entirely through the body.

13. A hemostasis valve assembly, comprising:
a hub body defining a cavity;
a strain relief portion extending distally from the hub body;
an end cap coupled to a proximal end of the hub body; and
a hemostasis valve positioned within the cavity of the hub body and coupled between the hub body and the end cap;
wherein the hemostasis valve comprises a valve body having a proximal side, a distal side, and a central region defined by a perimeter and having a diametrical center point, wherein the proximal side of the central region includes a distally extending proximal surface that slopes toward the distal side of the valve body, wherein an entirety of the distally extending proximal surface that extends between the perimeter of the central region and the diametrical center point of the central region is linear, and wherein the distal side of the central region includes a distally extending distal surface that extends between the perimeter of the central region and the diametrical center point of the central region, wherein an entirety of the distally extending distal surface in the central region has a shape that is different from a shape of the distally extending proximal surface in the central region.

14. The hemostasis valve assembly of claim 13 , wherein the valve body comprises an elastomeric silicone.

15. The hemostasis valve assembly of claim 13 , wherein the valve body comprises a liquid silicone rubber (LSR).

16. The hemostasis valve assembly of claim 13 , wherein the valve body comprises an enhanced tear resistant (ETR) silicone elastomer.

17. The hemostasis valve assembly of claim 13 , further comprising one or more slits formed in the valve body and extending at least partially through a thickness of the valve body in the central region.

18. The hemostasis valve assembly of claim 13 , wherein the valve body further comprises a first annular groove formed in the proximal side and a second annular groove formed in the distal side, the first annular groove configured to engage an interlocking feature in the end cap and the second annular groove configured to engage an interlocking feature in the hub body.

19. The hemostasis valve assembly of claim 13 , wherein thickness of the valve body is measured between the proximal side and the distal side, wherein the valve body has a first thickness at the perimeter of the central region and a second thickness at the diametrical center point, wherein the second thickness is less than the first thickness.

20. A hemostasis valve assembly, comprising:
a hub body defining a cavity;
a strain relief portion extending distally from the hub body;
an end cap coupled to a proximal end of the hub body; and
a hemostasis valve positioned within the cavity of the hub body and coupled between the hub body and the end cap, the hemostasis valve comprising:
an elastomeric valve body having a proximal side, a distal side, and a central region defined by a perimeter and having a diametrical center point, wherein the proximal side of the central region includes a distally extending proximal surface that slopes toward the distal side of the valve body, wherein an entirety of the distally extending proximal surface that extends between a perimeter of the central region and the diametrical center point of the central region is linear, and wherein the distal side of the central region includes a distally extending distal surface that extends between the perimeter of the central region and the diametrical center point of the central region, wherein an entirety of the distally extending distal surface in the central region has a shape that is different from a shape of the distally extending proximal surface in the central region;
a first annular groove formed in the proximal side of the valve body;
a second annular groove formed in the distal side of the valve body; and
a flanged outer perimeter.

Assignees

• Boston Scient Ltd

Inventors

• Agrawal Sumit
• Pepin Henry J
• Reddy Somashekar

Classifications

• A61M39/06 Primary

  Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof · CPC title

• A61M25/0097

  characterised by the hub (connectors A61M39/10) · CPC title

• A61M39/0606 Primary

  without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence) · CPC title

• A61M2025/0098

  having a strain relief at the proximal end, e.g. sleeve · CPC title

• A61M2039/062

  used with a catheter · CPC title