Reduced-friction catheter introducer and method of manufacturing and using the same

• US 9,597,483 B2
• Filed: 11/29/2005
• Issued: 03/21/2017
• Est. Priority Date: 11/29/2004
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: King, Eric M., Wortley, Ronald
• Primary Examiner(s): DeSanto, Matthew F
• Application Number:
  US11/288,959
• Publication Number:
  US 20060149293A1
• Time in Patent Office: 4,130 Days
• Field of Search: 604/158, 604104-109, 604/256, 604/264, 60416401-16407, 60416701-16704, 60416501-16504, 604/164.1, 604/164.13, 604/167.06, 60417001-17003, 604/537, 604533-535
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2039/2426 Slit valve
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

Tear-away and non-tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. The sheath introducers contain movable valves that are encapsulated in a movable housing unlike conventional valves that are stationary. The movable housing allows the valve to move along the axis of the introducer. As the movable valve and housing travel along the axis, a portion of the hub protrudes past the valve and is exposed. The protruding portion of the hub contains a friction-free pathway for the catheter into the sheath introducer. The introducers can therefore be used with any catheter, regardless of the size or material, because of the reduced or eliminated frictional force between the catheter and introducer.

Claims

1. A sheath introducer for a catheter, comprising:

a hub including a splittable valve penetration member that forms a friction-reduced port for insertion of the catheter through the sheath introducer;

a valve housing movable with respect to the hub; and

a valve positioned in the valve housing biased in a closed position to prevent fluid flow therethrough, the valve comprising;

a base including an opening;

a closed upper surface including a slit; and

a channel extending from the base opening to the upper surface, the channel abutting an outer surface of the splittable valve penetration member in the closed position,

wherein movement of the valve housing with respect to the hub transitions the valve from the closed position to an open position.

2. The sheath introducer of claim 1, wherein the valve penetration member comprises one or more stress risers.

3. The sheath introducer of claim 2, wherein the one or more stress risers includes a first stress riser on a first side of the valve penetration member and a second stress riser on a second side of the valve penetration member opposite the first side.

4. The sheath introducer of claim 3, wherein the valve penetration member further comprises a first notch in the first side of the valve penetration member and a second notch in the second side of the valve penetration member, wherein the first notch is aligned with the first stress riser and the second notch is aligned with the second stress riser.

5. The sheath introducer of claim 2, wherein the valve penetration member further comprises one of more notches in a wall of the valve penetration member.

6. The sheath introducer of claim 1, wherein the valve comprises a substantially flexible material.

7. The sheath introducer of claim 1, wherein the valve housing and valve penetration member comprise a substantially rigid material.

8. The sheath introducer of claim 1, wherein the valve comprises a ring sealing member in the channel.

9. The sheath introducer of claim 1, wherein the valve comprises a coating on a wall of the valve defining the channel.

10. The sheath introducer of claim 1, wherein movement of the valve to the open position includes penetrating the slit with the valve penetration member such that a portion of the valve penetration member extends through the upper surface of the valve.

11. The sheath introducer of claim 1, wherein the valve is made from a translucent or transparent material to provide a flash-back chamber.

12. The sheath introducer of claim 1, further comprising a spring positioned between the valve housing and the hub, the spring biasing the valve in the closed position.

13. A system for inserting a catheter into a body, the system comprising a sheath introducer comprising:

a hub including a splittable valve penetration member comprising one or more stress risers; and

a valve housing movable with respect to the hub, the valve housing including a valve biased in a closed position.

14. The system of claim 13, wherein the valve moves from the closed position to an open position where the valve is penetrated by the valve penetration member, with a portion of the valve penetration member extending through the valve after penetration and the valve forming a seal around the valve penetration member in the open position.

15. The system of claim 14, wherein the extended portion of the valve penetration member comprises a friction-reduced insertion port.

16. The system of claim 13, wherein the one or more stress risers includes a first stress riser on a first side of the valve penetration member and a second stress riser on a second side of the valve penetration member opposite the first side.

17. The system of claim 16, wherein the valve penetration member further comprises a first notch in the first side of the valve penetration member and a second notch in the second side of the valve penetration member, wherein the first notch is aligned with the first stress riser and the second notch is aligned with the second stress riser.

18. The system of claim 13, wherein the valve comprises:

a base including an opening;

a closed upper surface including a slit; and

a channel extending from the base opening to the upper surface, the channel abutting an outer surface of the valve penetration member.

19. A method for inserting a catheter into a body, the method comprising:

providing a tear away sheath introducer, comprising;

a sheath;

a sheath hub coupled to a proximal end of the sheath, the sheath hub including a splittable valve penetration member;

a valve housing coupled to the sheath hub, the valve housing including a valve, the valve comprising;

a base including an opening;

a closed upper surface including a slit; and

a channel extending from the base opening to the upper surface, the channel abutting an outer surface of the splittable valve penetration member;

inserting a distal portion of the sheath into the body;

moving the valve housing with respect to the sheath hub to cause the splittable valve penetration member to penetrate the closed upper surface of the valve through the slit; and

inserting the catheter into an opening of the splittable valve penetration member extending through the closed upper surface of the valve, through the tear away sheath introducer, and into the body.

20. The method of claim 19, wherein the tear away sheath introducer further comprises a dilator extending through the sheath such that a distal end of the dilator is distal of the distal end of the sheath, further comprising removing the dilator prior to moving the valve housing.

21. The method of claim 19, further comprising splitting the tear away sheath introducer in two or more parts from around the catheter such that the catheter remains in an inserted position in the body.