Hemostasis valves and methods for making and using hemostasis valves

Patent metadata

Field	Value
Publication number	US-11291821-B2
Application number	US-201815905064-A
Country	US
Kind code	B2
Filing date	Feb 26, 2018
Priority date	Mar 13, 2017
Publication date	Apr 5, 2022
Grant date	Apr 5, 2022

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 including a seal member. The cartridge may have a proximal member, a distal member, and may define a seal holding region. The seal member may have an axial thickness of about 0.04 to about 0.2 inches. The seal member may be secured within the seal holding region by a mechanical bond.

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 first seal member;
wherein the cartridge has a proximal member, a distal member, and defines a seal holding region;
wherein the main body includes a second seal member disposed within the proximal end region, wherein the first seal member is spaced apart from the second seal member;
wherein when the hemostasis valve is in a relaxed, unactuated configuration, the first seal member is in a closed position and the second seal member is in an open position;
wherein the second seal member is manually actuatable between the open position and a closed position by movement of the cartridge, and remains in the open position until manually actuated to the closed position;
wherein the first seal member has an axial thickness of 0.04-0.2 inches; and
wherein the first seal member is secured within the seal holding region by a mechanical bond.

2. The hemostasis valve of claim 1 , wherein the mechanical bond includes a crimp.

3. The hemostasis valve of claim 1 , wherein the first seal member has an axial thickness of 0.075-0.095 inches.

4. The hemostasis valve of claim 1 , wherein the first seal member has a distal face with a distal slit, wherein the first seal member has a proximal face with a proximal slit; and wherein the distal slit and the proximal slit are axially spaced 0.01-0.02 inches.

5. The hemostasis valve of claim 4 , wherein the distal slit is arranged orthogonally with the proximal slit.

6. The hemostasis valve of claim 1 , further comprising a plunger coupled to the proximal end region of the main body, the plunger configured to slide distally to move the first seal member from the closed position to an open position, the plunger configured to be rotated to move the cartridge which moves the second seal member from the open position to the closed position.

7. The hemostasis valve of claim 1 , wherein the first seal member has a seal body and a peripheral region designed to engage the seal holding region of the cartridge.

8. The hemostasis valve of claim 7 , wherein the peripheral region has a radial thickness of 0.001-0.02 inches.

9. The hemostasis valve of claim 7 , wherein the central seal region has a width that is at least twice as large as a radial thickness of the peripheral region.

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

11. A hemostasis valve, comprising:
a main body having a threaded proximal end region;
a nut threadably engaged with the threaded proximal end region;
a plunger coupled to the threaded proximal end region;
a cartridge at least partially disposed within the threaded proximal end region, the cartridge including a first seal member;
wherein the main body includes a second seal member disposed within the threaded proximal end region, wherein the first seal member is spaced apart from the second seal member;
wherein the plunger is configured to move the first seal member from a closed position to an open position;
wherein the second seal member is manually actuatable by rotating the plunger to move the second seal member between an open position and a closed position, wherein the second seal member remains in the open position until manually actuated to the closed position;
wherein the first seal member is secured within a seal holding region of the cartridge by a mechanical bond; and
wherein the first seal member has an axial thickness of 0.04-0.2 inches.

12. The hemostasis valve of claim 11 , wherein the mechanical bond includes a crimp.

13. The hemostasis valve of claim 11 , wherein the first seal member has an axial thickness of 0.075-0.095 inches.

14. The hemostasis valve of claim 11 , wherein the first seal member has a distal face with a distal slit, wherein the first seal member has a proximal face with a proximal slit; and wherein the distal slit and the proximal slit are axially spaced 0.01-0.02 inches.

15. The hemostasis valve of claim 14 , wherein the distal slit is arranged orthogonally with the proximal slit.

16. The hemostasis valve of claim 11 , wherein the first seal member has a central seal region and a peripheral leg region designed to engage the seal holding region of the cartridge.

17. The hemostasis valve of claim 16 , wherein the peripheral leg region has a radial thickness of 0.001-0.02 inches.

18. The hemostasis valve of claim 16 , wherein the central seal region has a width that is at least twice as large as a radial thickness of the peripheral leg region.

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 plunger coupled to the threaded proximal end region;
a cartridge at least partially disposed within the threaded proximal end region, the cartridge including a first seal member;
wherein the first seal member is secured within a seal holding region of the cartridge by a crimp bond;
wherein the main body includes a second seal member disposed within the threaded proximal end region, wherein the first seal member is spaced apart from the second seal member;
wherein the plunger is configured to move the first seal member from a closed position to an open position;
wherein the second seal member is manually actuatable by rotating the plunger to move the second seal member between an open position and a closed position, wherein the second seal member remains in the open position until manually actuated to the closed position;
wherein the first seal member has a central seal region and a peripheral leg region designed to engage the seal holding region of the cartridge; and
wherein the central seal region has a width that is at least twice as large as a radial thickness of the peripheral leg region.

20. The hemostasis valve of claim 19 , wherein the first seal member has an axial thickness of 0.075-0.095 inches.

Assignees

• Boston Scient Ltd

Inventors

• Agrawal Sumit
• Pepin Henry J

Classifications

• A61M39/06 Primary

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

• A61M39/0606

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

• A61M5/007

  for contrast media · CPC title

• A61M39/0613 Primary

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

• A61M2039/064

  Slit-valve · CPC title