Hemostasis valves and methods for making and using hemostasis valves

Patent metadata

Field	Value
Publication number	US-10569072-B2
Application number	US-201815904829-A
Country	US
Kind code	B2
Filing date	Feb 26, 2018
Priority date	Mar 13, 2017
Publication date	Feb 25, 2020
Grant date	Feb 25, 2020

Abstract

Hemostasis valves and methods for making and using hemostasis valves are disclosed. An example hemostasis valve may include a main body having a proximal end region. A cartridge may be at least partially disposed within the proximal end region. The cartridge may include a seal member. The seal member may be designed to shift between an open configuration and a sealed configuration. A plunger, having an inner tubular region and a distal end, may be coupled to the proximal end region of the main body. The distal end of the inner tubular region may be spaced a clearance distance from a proximal end of the seal member so that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

First claim

What is claimed is:

1. A hemostasis valve, comprising:
a main body having a proximal end region;
a cartridge at least partially disposed within the proximal end region, the cartridge including a seal member;
wherein the seal member is designed to shift between an open configuration and a sealed configuration;
a plunger coupled to the proximal end region of the main body, the plunger having an inner tubular region having a distal end;
wherein the distal end of the inner tubular region is spaced a clearance distance from a proximal end of the seal member so that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

2. The hemostasis valve of claim 1 , wherein the clearance distance has an axial dimension of 0.1 to 5 millimeters.

3. The hemostasis valve of claim 1 , wherein the clearance distance has an axial dimension of 0.3 to 2 millimeters.

4. The hemostasis valve of claim 1 , wherein the clearance distance is designed so that when the seal member is in the sealed configuration and exposed to pressures of 100-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

5. The hemostasis valve of claim 1 , wherein the clearance distance is designed so that when the seal member is in the sealed configuration and exposed to pressures of 80-200 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

6. The hemostasis valve of claim 1 , wherein the proximal end region of the main body includes a retaining protrusion.

7. The hemostasis valve of claim 6 , wherein the plunger has a distal retaining flange designed to engage the retaining protrusion.

8. The hemostasis valve of claim 1 , wherein a spring member is disposed within the plunger and engaged with a proximal end of the plunger.

9. The hemostasis valve of claim 1 , further comprising a nut threadably engaged with one or more threads along the proximal end region of the main body.

10. The hemostasis valve of claim 1 , wherein the inner tubular region has a wall thickness that varies along the length thereof.

11. The hemostasis valve of claim 1 , wherein the inner tubular region has an inner diameter that varies along the length thereof.

12. A hemostasis valve, comprising:
a main body having a proximal end region;
a cartridge at least partially disposed within the proximal end region, the cartridge including a seal member;
wherein the seal member is designed to shift between an open configuration and a sealed configuration;
a plunger coupled to the proximal end region of the main body, the plunger having an inner tubular region having a distal end;
wherein the seal member and the plunger are arranged so that there is a clearance distance between a proximal face of the seal member and the distal end of the inner tubular region such that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the proximal face of the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

13. The hemostasis valve of claim 12 , wherein the clearance distance has an axial dimension of 0.1 to 5 millimeters.

14. The hemostasis valve of claim 12 , wherein the clearance distance has an axial dimension of 0.3 to 2 millimeters.

15. The hemostasis valve of claim 12 , wherein the clearance distance is designed so that when the seal member is in the sealed configuration and exposed to pressures of 100-250 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

16. The hemostasis valve of claim 12 , wherein the clearance distance is designed so that when the seal member is in the sealed configuration and exposed to pressures of 80-200 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

17. The hemostasis valve of claim 12 , wherein the proximal end region of the main body includes a retaining protrusion and wherein the plunger has a distal retaining flange designed to engage the retaining protrusion.

18. The hemostasis valve of claim 12 , further comprising a nut threadably engaged with one or more threads along the proximal end region of the main body.

19. A hemostasis valve, comprising:
a main body having a threaded proximal end region;
a nut threadably engaged with the threaded proximal end region;
a cartridge at least partially disposed within the threaded proximal end region, the cartridge including a seal member;
wherein the seal member is designed to shift between an open configuration and a sealed configuration;
a plunger coupled to the threaded proximal end region of the main body, the plunger having an inner tubular region having a distal end;
wherein the seal member and the plunger are arranged so that there is a clearance distance between a proximal face of the seal member and the distal end of the inner tubular region such that when the seal member is in the sealed configuration and exposed to pressures of 80-250 pounds per square inch, the proximal face of the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

20. The hemostasis valve of claim 19 , wherein the clearance distance has an axial dimension of 0.3 to 2 millimeters and wherein the clearance distance is designed so that when the seal member is in the sealed configuration and exposed to pressures of 80-200 pounds per square inch, the seal member deflects into contact with the distal end of the inner tubular region and remains in the sealed configuration.

Assignees

• Boston Scient Ltd

Inventors

• Agrawal Sumit
• Pepin Henry J

Classifications

• A61M39/0613

  with means for adjusting the seal opening or pressure (A61M39/0693 takes precedence) · CPC title

• A61M39/06 Primary

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

• A61M2039/0673

  comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps · CPC title

• A61M2039/062

  used with a catheter · CPC title