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

• US 8,403,890 B2
• Filed: 03/06/2009
• Issued: 03/26/2013
• 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 Michael, Beal, James D.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US12/399,749
• Publication Number:
  US 20090177163A1
• Time in Patent Office: 1,481 Days
• Field of Search: 60416401-16412, 60416701-16704, 604533-535, 604/246, 604/256
• US Class Current: 604/167.03
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

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 that 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. As well, the sheath introducers can also contain a stationary valve and housing that can be opened to expose a portion of the hub when a conduit penetrates the stationary valve. The conduit can include a one-way valve actuator that can penetrate and open the valve, yet remain attached to a portion of the introducer when the introducer is split for removal from a patient. In both instances, the protruding portion of the hub contains a friction-free pathway for a catheter into the sheath introducer.

Claims

1. A splittable sheath introducer, comprising:

a sheath;

a hub disposed at a proximal end of the sheath;

a valve included with the hub; and

a valve actuator movable from a first position to a second position, the valve actuator opening the valve when in the second position, the valve actuator including;

a retaining member that enables the valve actuator to be retained by a portion of the hub when the sheath introducer is split apart; and

a bottom portion that includes an extended surface that opens the valve when the valve actuator is in the second position, the extended surface defining a cross-sectional shape selected from a C-shape and a U-shape.

2. The sheath introducer as defined in claim 1, wherein the valve actuator engages a corresponding retaining member of the hub such that the valve actuator is retained by a portion of the hub when the sheath introducer is split apart.

3. The sheath introducer as defined in claim 2, wherein the retaining member of the valve actuator includes a tongue longitudinally defined on an outer surface of the valve actuator, and wherein the retaining member of the hub includes a groove that receives the tongue of the valve actuator.

4. The sheath introducer as defined in claim 1, wherein the valve actuator is substantially coaxial with a longitudinal axis of the sheath introducer, and wherein the valve actuator further includes a conduit that enables passage of a catheter through the valve actuator and through the valve when the valve actuator is in the second position.

5. The sheath introducer as defined in claim 4, wherein the valve actuator is non-splittable and further includes a longitudinally defined channel for enabling the removal of the catheter therefrom when the sheath introducer is split.

6. The sheath introducer as defined in claim 1, wherein the hub is formed from a translucent material to enable a user to view the cavity of the hub.

7. The sheath introducer as defined in claim 6, wherein the hub further includes a magnifier portion that magnifies a portion of the cavity of the hub.

8. The sheath introducer as defined in claim 1, wherein the valve actuator includes a top surface that enables the valve actuator to be pressed by a user from the first position to the second position.

9. A splittable sheath introducer, comprising:

a sheath;

a hub disposed at a proximal end of the sheath;

a valve disposed in the hub; and

a valve actuator including;

a body defining a conduit pathway extending from a proximal end to a distal end thereof, the body further defining a longitudinal channel through a side of the body in communication with the conduit pathway; and

a surface on the body for enabling a user to apply force to the valve actuator in a direction substantially coaxial with a longitudinal axis of the valve actuator, the force enabling movement of the valve actuator from a first position to a second position, wherein the distal end of the valve actuator opens the valve when the valve actuator is moved from the first position to the second position.

10. The sheath introducer as defined in claim 9, wherein the valve actuator is disposed in a cavity of the hub, and wherein the sheath introducer further comprises:

means for preventing separation of the valve actuator from a portion of the hub when the hub is split.

11. The sheath introducer as defined in claim 10, wherein the means for preventing separation includes:

a tongue defined on an outer surface of the valve actuator; and

a groove defined on an inside surface of the cavity of the hub, the groove receiving the tongue of the valve actuator.

12. The sheath introducer as defined in claim 11, wherein the groove is interposed between a first plurality of teeth and a second plurality of teeth defined on the inside surface of the cavity of the hub.

13. The sheath introducer as defined in claim 9, further comprising:

at least one interference feature defined by the actuator body, the interference feature enabling one-way movement of the actuator from the first position to the second position; and

at least one interference feature defined by the hub that engages the at least one interference feature of the valve actuator to prevent movement of the valve actuator from the second position to the first position.

14. The sheath introducer as defined in claim 13, wherein:

the at least one interference feature of the valve actuator includes a plurality of teeth circumferentially defined about a portion of the outer surface of the actuator; and

the at least one interference feature of the hub includes a plurality of teeth defined on an inside surface of the cavity of the hub.

15. The sheath introducer as defined in claim 9, wherein the conduit pathway of valve actuator provides access to the sheath via the valve when the valve actuator is in the second position.

16. A method for inserting a catheter, comprising:

providing a splittable sheath introducer, the sheath introducer including a sheath, a sheath hub disposed at a proximal end of the sheath, a valve disposed in the sheath hub, and a valve actuator disposed in a cavity of the sheath hub;

inserting a distal portion of the sheath into a portion of a body of a patient;

moving the valve actuator from a first position to a second position so as to open the valve;

inserting a catheter into the body of the patient through the open valve and the sheath via a conduit pathway defined by the valve actuator; and

splitting the sheath introducer such that the catheter passes through a channel defined in the valve actuator and such that the valve actuator remains attached to a portion of the sheath hub after the sheath introducer is split.

17. The method for inserting as defined in claim 16, wherein moving the valve actuator further comprises moving the valve actuator from the first position to the second position, wherein interference features included on at least one of the valve actuator and the cavity of the hub prevent backward movement of the valve actuator from the second position to the first position.

18. The method for inserting as defined in claim 16, wherein moving the valve actuator further comprises:

moving the valve actuator from a first position to a second position via direct finger pressure on the valve actuator in a direction that is axially aligned with the valve actuator.