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

• US 10,398,879 B2
• Filed: 03/10/2017
• Issued: 09/03/2019
• 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:
  US15/456,258
• Publication Number:
  US 20170182294A1
• Time in Patent Office: 907 Days
• 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

A sheath introducer for a catheter includes a sheath having a lumen, a hub positioned on a proximal end of the sheath, and a housing positioned on the hub. The hub can include a splittable penetration member having a port in fluid communication with the sheath lumen. The housing can include a valve having a closed upper surface and a channel surrounding the splittable penetration member. Movement of the housing with respect to the hub can expose the port of the splittable penetration member for insertion of the catheter.

Claims

1. A sheath introducer for a catheter, comprising:

a sheath having a lumen;

a hub positioned on a proximal end of the sheath, the hub including a splittable penetration member comprising a port in fluid communication with the lumen of the sheath; and

a housing positioned on the hub, the housing including a valve comprising a closed upper surface and a channel surrounding the splittable penetration member, wherein movement of the housing with respect to the hub exposes the port of the splittable penetration member for insertion of the catheter.

2. The sheath introducer according to claim 1, wherein the splittable penetration member further comprises one or more stress risers.

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

4. The sheath introducer according to claim 3, wherein a portion of the splittable penetration member further comprises a first notch in the first side of the splittable penetration member and a second notch in the second side of the splittable 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 according to claim 2, wherein the splittable penetration member further comprises one of more notches in a wall thereof.

6. The sheath introducer according to claim 1, wherein the valve comprises a substantially flexible material, and the splittable penetration member comprises a substantially rigid material.

7. The sheath introducer according to claim 1, wherein the valve further comprises a ring sealing member disposed on an inner surface of the valve, the ring sealing member extending radially into the channel and in contact with the splittable penetration member.

8. The sheath introducer according to claim 1, wherein the valve further comprises a coating on an inner surface of the valve.

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

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

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

providing a tear away sheath introducer, comprising;

a sheath;

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

a housing coupled to the hub, the housing including a valve comprising a closed upper surface and a channel surrounding the splittable penetration member;

inserting a distal portion of the sheath into the body;

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

inserting the catheter into a port of the splittable penetration member, through the tear away sheath introducer, and into the body.

12. The method according to claim 11, 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 a distal end of the sheath, further comprising removing the dilator prior to moving the housing.

13. The method according to claim 11, 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.