Safety introducer assembly and method

• US 7,001,396 B2
• Filed: 03/26/2003
• Issued: 02/21/2006
• Est. Priority Date: 03/26/2003
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Enpath Medical, Inc. (Integer Holdings Corporation Inc)
• Inventors: Glazier, Valerie, Latterell, Todd
• Primary Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US10/403,265
• Publication Number:
  US 20040193112A1
• Time in Patent Office: 1,063 Days
• Field of Search: 604/23, 604/26, 604/44, 604/500, 604506-508, 604/117, 604/110, 604/158, 604161-163, 604/164.01, 60416405-16412, 604/170.01, 604/170.02, 604/264, 604/263, 604/164.03, 606/167, 606/170, 606/181, 606/182, 606/185, 606/108
• US Class Current: 606/108
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

An introducer assembly includes an outer sheath, and a dilator assembly that includes a dilator hub and a dilator sheath. The dilator sheath is disposed within the outer sheath passage, and a proximal end of the dilator sheath is movably disposed within the dilator hub. The dilator assembly further includes a needle disposed within the dilator sheath, and coupled with the dilator hub. The dilator sheath has a first position and a second position relative to the dilator hub, where in the first position the needle distal end extends out from the dilator sheath distal end, and in the second position the dilator sheath is extended over the needle distal end.

Claims

1. An introducer assembly comprising:

an outer sheath extending from an outer sheath proximal end to an outer sheath distal end, the outer sheath having an outer sheath passage therethrough;

a dilator assembly including a dilator hub and a dilator sheath, the dilator sheath disposed within the outer sheath passage, the dilator sheath extending from a dilator sheath proximal end to a dilator sheath distal end, the dilator sheath proximal end movably disposed within the dilator hub;

the dilator assembly including a needle disposed within the dilator sheath, the needle extending from a needle proximal end to a needle distal end, the needle proximal end coupled with the dilator hub;

the dilator sheath having a first position and a second position relative to the dilator hub, in the first position the needle distal end extends out from the dilator sheath distal end, in the second position the dilator sheath is extended over the needle distal end; and

the dilator sheath frictionally retained by the outer sheath until the dilator sheath is disposed in the second position.

2. The introducer assembly as recited in claim 1, further comprising a catch disposed at the dilator sheath proximal end and a shoulder disposed within the dilator hub, wherein the catch is disposed against the shoulder when the dilator sheath is disposed in the second position.

3. The introducer assembly as recited in claim 2, wherein the catch further comprises at least one resilient arm extending therefrom.

4. The introducer assembly as recited in claim 1, further comprising a spring disposed within the dilator hub, where at least a portion of the spring is disposed between the dilator hub and the dilator sheath proximal end.

5. The introducer assembly as recited in claim 1, further comprising a ring disposed on the dilator sheath, the ring disposed against a portion of the outer sheath when the dilator sheath is in the first position.

6. The introducer assembly as recited in claim 1, further comprising at least one reset member coupled with the dilator assembly.

7. The introducer assembly as recited in claim 6, wherein the at least one reset member is disposed in an at least partially exposed position when the dilator sheath is disposed in the second position.

8. The introducer assembly as recited in claim 6, wherein the at least one reset member is disposed within the dilator hub when the dilator sheath is disposed in the first position.

16. The introducer assembly as recited in claim 1, wherein the dilator assembly is coupled with the outer sheath when the dilator sheath is in the first position, and the dilator assembly is not coupled with the outer sheath when the dilator sheath is in the second position.

9. An introducer assembly comprising:

an outer sheath extending from an outer sheath proximal end to an outer sheath distal end, the outer sheath having a sheath passage therethrough;

a dilator assembly including a dilator hub and a dilator sheath, at least a portion of the dilator sheath movably disposed within the dilator hub, the dilator sheath having a dilator sheath proximal end and a dilator sheath distal end;

the dilator assembly including a needle disposed within the dilator sheath, the needle extending from a needle proximal end to a needle distal end;

at least one resilient member disposed between the dilator sheath and the dilator hub;

the dilator sheath having a first position and a second position, in the first position the needle is extended out through the sheath distal end and the resilient member is at least partially compressed, in the second position the dilator sheath distal end is disposed over the needle distal end; and

wherein the dilator assembly is coupled with the outer sheath when the dilator sheath is in the first position, and the dilator assembly is not coupled with the outer sheath when the dilator sheath is in the second position.

10. The introducer assembly as recited in claim 9, wherein the resilient member is less compressed when the dilator sheath is in the second position than in the first position.

11. The introducer assembly as recited in claim 9, further comprising at least one reset member coupled with the dilator assembly.

12. The introducer assembly as recited in claim 11, wherein the at least one reset member is disposed in an at least partially exposed position when the dilator sheath is disposed in the second position.

13. The introducer assembly as recited in claim 11, wherein the at least one reset member is disposed within the dilator hub when the dilator sheath is disposed in the first position.

14. The introducer assembly as recited in claim 9, further comprising means for preventing re-exposure of the needle after the sheath is placed in the second position.

15. The introducer assembly as recited in claim 9, wherein the dilator sheath is retained by the outer sheath in a friction fit when the sheath is disposed in the first position.

17. An introducer assembly comprising:

an outer sheath extending from an outer sheath proximal end to an outer sheath distal end, the outer sheath having a sheath passage therethrough;

a dilator assembly including a dilator hub and a dilator sheath, at least a portion of the dilator sheath movably disposed within the dilator hub, the dilator sheath having a dilator sheath proximal end and a dilator sheath distal end;

the dilator assembly including a needle disposed within the dilator sheath, the needle extending from a needle proximal end to a needle distal end;

at least one resilient member disposed between the dilator sheath and the dilator hub;

the dilator sheath having a first position and a second position, in the first position the needle is extended out through the sheath distal end and the resilient member is at least partially compressed, in the second position the dilator sheath distal end is disposed over the needle distal end; and

wherein moving the dilator assembly axially away from the outer sheath moves the dilator sheath from first position to the second position.

18. A method comprising:

disposing a dilator assembly within an outer sheath, the outer sheath extending from an outer sheath proximal end to an outer sheath distal end, the outer sheath having a sheath passage therethrough, the dilator assembly including a dilator hub and a dilator sheath, the dilator movably disposed within the dilator hub, the dilator assembly including a needle disposed within the dilator sheath, the needle extending from a needle proximal end to a needle distal end, at least one resilient member disposed between the dilator sheath and the dilator hub, the dilator sheath having a first position and a second position, in the first position the needle is extended out through the sheath distal end and the resilient member is at least partially compressed, in the second position the dilator sheath distal end is disposed over the needle distal end;

moving the needle toward the outer sheath proximal end; and

moving the dilator sheath from the first position to the second position with the resilient member while the needle is moved toward the outer sheath proximal end; and

coupling the dilator assembly with the outer sheath while the dilator sheath is disposed in the first position.

19. The method as recited in claim 18, further comprising resetting the dilator sheath to the first position.

20. The method as recited in claim 19, wherein resetting the dilator sheath to the first position includes depressing a reset member and moving the dilator sheath towards the dilator hub.

21. The method as recited in claim 18, further comprising frictionally retaining the dilator sheath with the outer sheath while the needle is moved toward the outer sheath proximal end.

22. The method as recited in claim 18, further comprising uncoupling the dilator assembly from the outer sheath and allowing the dilator sheath to move from the first position to the second position.

23. A method comprising:

coupling a dilator assembly with a catheter assembly, the catheter assembly including an outer sheath extending from an outer sheath proximal end to an outer sheath distal end, the outer sheath having an outer sheath passage therethrough;

the dilator assembly including a dilator hub and a dilator sheath, the dilator sheath disposed within the outer sheath passage, the dilator sheath extending from a dilator sheath proximal end to a dilator sheath distal end, the dilator sheath proximal end movably disposed within the dilator hub;

the dilator assembly including a needle disposed within the dilator sheath, the needle extending from a needle proximal end to a needle distal end, the needle proximal end coupled with the dilator hub;

moving the dilator hub and the needle along the longitudinal axis toward the outer sheath proximal end;

frictionally retaining the dilator sheath with the outer sheath while the needle is moved toward the outer sheath proximal end;

disposing the dilator sheath distal end over the needle distal end.

24. The method as recited in claim 23, further comprising resetting the dilator sheath and exposing the needle distal end after the dilator sheath distal end is disposed over the needle distal end.

25. The method as recited in claim 24, wherein resetting the dilator sheath includes depressing a reset member and moving the dilator sheath towards the dilator hub.

26. The method as recited in claim 23, further comprising coupling the dilator assembly with the outer sheath while the needle distal end extends out from the dilator sheath distal end.

27. The method as recited in claim 23, further comprising moving the dilator sheath to a position over the needle distal end with a resilient member coupled between the dilator hub and the dilator sheath.

28. The method as recited in claim 23, further comprising uncoupling the dilator assembly from the outer sheath and allowing the dilator sheath to move from the first position to the second position.