Sheath Introducer with Self-Anchoring Mechanism

• US 20110106012A1
• Filed: 10/29/2010
• Published: 05/05/2011
• Est. Priority Date: 10/29/2009
• Status: Abandoned Application

• Current Assignee: Franz E. Velarde
• Original Assignee: Franz E. Velarde
• Inventors: Velarde, Franz E.
• Application Number:
  US12/915,543
• Publication Number:
  US 20110106012A1
• Time in Patent Office: Days
• US Class Current: 604/164.03
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

An assembly for accessing a vessel comprises an elongate housing having a longitudinal axis, a proximal end, and a distal end opposite the proximal end. The housing includes a base extending from the proximal end, an elongated tubular extending from the distal end to the base, and a throughbore extending axially from the proximal end to the distal end. In addition, the assembly comprises a stylet extending axially through the throughbore of the housing. The stylet has a proximal end comprising an actuation head external the throughbore of the housing, and a distal end opposite the proximal end of the stylet. Further, the assembly comprises an expandable member coupled to the distal end of the housing or the distal end of the stylet. The expandable member has an expanded position with a first diameter and an unexpanded position with a second diameter that is less than the first diameter. Further, the stylet is adapted to transition the expandable member between the unexpanded position and the unexpanded position by moving axially through the housing.

Claims

1. An assembly for accessing a vessel, comprising:

an elongate housing having a longitudinal axis, a proximal end, and a distal end opposite the proximal end, wherein the housing includes a base extending from the proximal end, an elongated tubular extending from the distal end to the base, and a throughbore extending axially from the proximal end to the distal end;

a stylet extending axially through the throughbore of the housing, wherein the stylet has a proximal end comprising an actuation head external the throughbore of the housing, and a distal end opposite the proximal end of the stylet; and

an expandable member coupled to the distal end of the housing or the distal end of the stylet, wherein the expandable member has an expanded position with a first diameter and an unexpanded position with a second diameter that is less than the first diameter, wherein the stylet is adapted to transition the expandable member between the unexpanded position and the unexpanded position by moving axially through the housing.

2. The assembly of claim 1, wherein the stylet threadingly engages the housing;

and

wherein the stylet is adapted to be rotated about the longitudinal axis relative to the housing in a first direction to transition the expandable member to the expanded position and rotated about the longitudinal axis relative to the housing in a second direction to transition the expandable member to the unexpanded position.

3. The assembly of claim 1, further comprising a locking mechanism disposed between the housing and the stylet, wherein the locking mechanism is adapted to releasably lock the stylet relative to the housing.

4. The assembly of claim 1, wherein the expandable member comprises an annular wire mesh, a plurality of circumferentially spaced strips, a plurality of resilient wires, a flexible annular flange, or a flexible, hollow conical structure.

5. The assembly of claim 1, wherein the distal end of the stylet extends axially from the distal end of the housing, and wherein the expandable member is axially disposed between the distal end of the housing and the stylet, and wherein the expandable member extends axially between a first end attached to the distal end of the housing and a second end attached to stylet.

6. The assembly of claim 5, wherein the distal end of the stylet comprises a tapered curved tip.

7. The assembly of claim 5, wherein the expandable member is biased to the unexpanded position.

8. The assembly of claim 5, wherein the stylet comprises a throughbore extending axially from the proximal end of the stylet to the distal end of the stylet, and wherein a guide wire is slidably disposed in the throughbore of the stylet.

9. The assembly of claim 1, wherein the expandable member has a first end attached to the distal end of the housing a second end opposite the first end, and wherein the distal end of the stylet is disposed within the expandable member.

10. The assembly of claim 9, wherein the distal end of the stylet comprises an engagement member that engages an inner surface of the expandable member and is adapted to exert an axial force on the expandable member to transition the expandable member from the expanded position to the unexpanded position.

11. The assembly of claim 10, wherein the engagement member of the stylet is a ball and the elongate member of the stylet is a wire.

12. The assembly of claim 9, wherein the second end of the expandable member comprises a tapered curved tip.

13. The assembly of claim 10, wherein the expandable member is biased to the radially expanded position.

14. The assembly of claim 1, wherein the expandable member is attached to the distal end of the stylet, and wherein the expandable member is disposed within the housing in the unexpanded position and disposed external the housing in the expanded position.

15. The assembly of claim 14, wherein a throughbore extends axially from the proximal end of the stylet through the distal end of the stylet and the expandable member.

16. The assembly of claim 15, further comprising a guide wire disposed in the throughbore extending through the stylet, wherein the guide wire has a proximal end extending from the throughbore of the stylet at the proximal end of the stylet and a distal end extending through the expandable member, and wherein the guide wire is adapted to be moved axially relative to the stylet and the housing.

17. The assembly of claim 16, wherein the expandable member is biased to the expanded position, and wherein the expandable member is disposed within the housing in the unexpanded position and external the housing in the expanded position.

18. The assembly of claim 16, wherein the distal end of the stylet includes an annular recess adapted to receive a portion of the expandable member when the expandable member is in the unexpanded position.

19. The assembly of claim 1, wherein the expandable member comprises a plurality of circumferentially spaced wires;

wherein each wire has a first end coupled to the head and a second end opposite the first end; and

wherein the second end of each wire is blunted.

20. The assembly of claim 19, wherein the expandable member is biased to the expanded position;

and

wherein the second end of each wire is disposed within the housing in the unexpanded position and is external the housing in the expanded position.

21. The assembly of claim 1, further comprising a vascular sheath having a longitudinal axis, a proximal end, and a distal end opposite the proximal end, wherein the sheath includes a base extending axially from the proximal end, a tubular extending from the distal end to the base, and a throughbore extending between the proximal end and the distal end;

wherein the tubular of the elongate housing is disposed in the throughbore of the vascular sheath.

22. The assembly of claim 21, wherein the base of the housing includes a plurality of circumferentially spaced coupling arms adapted to releasably engage an annular recess on a radially outer surface of the base of the sheath.

23. A method for accessing a first limb and a second limb of an AV graft or fistula of a patient, the method comprising:

(a) providing a vascular sheath having a distal end disposed in the first limb and a proximal end external the patient, wherein the vascular sheath extends through a single puncture in the patient;

(b) inserting an introducer into the vascular sheath and advancing the introducer through the vascular sheath until a distal end of the introducer is disposed within the first limb;

(c) radially expanding an expandable member of the introducer within the first limb;

(d) withdrawing the vascular sheath from the first limb through the single puncture with the introducer after (c);

(e) restricting the distal end of the introducer from exiting the AV graft or fistula with the expandable member during (d); and

(f) advancing the introducer and the sheath through the single puncture and into the second limb.

24. The method of claim 23, wherein (e) comprises bearing against the inner surface of the AV graft or fistula with the expandable member.

25. The method of claim 23, wherein the introducer comprises:

an elongate housing having a longitudinal axis, a proximal end, and a distal end opposite the proximal end, and a throughbore extending axially from the proximal end to the distal end;

a stylet extending axially through the throughbore of the housing, wherein the stylet has a proximal end comprising an actuation head external the throughbore of the housing and a distal end opposite the proximal end of the stylet; and

the expandable member coupled to the distal end of the housing or the distal end of the stylet;

wherein (c) comprises moving the stylet axially relative to the housing.

26. The method of claim 25, wherein the stylet threadingly engages the housing, and wherein (c) comprises rotating the stylet about the longitudinal axis relative to the housing.

27. The method of claim 25, further comprising:

(g) radially contracting the expandable member after (f); and

(h) withdrawing the introducer from the sheath.

28. The method of claim 27, wherein (c) comprises extending the expandable member axially from the distal end of the housing and the distal end of the sheath;

and wherein (g) comprises withdrawing the expandable member axially into the sheath.

29. The method of claim 23, wherein the introducer comprises:

an elongate housing having a longitudinal axis, a proximal end, and a distal end opposite the proximal end, a central throughbore extending axially from the proximal end to the distal end, and a plurality of circumferentially spaced throughbores radially spaced from the central throughbore, wherein each of the circumferentially spaced throughbores extends axially from the proximal end to the distal end;

an actuation head external the throughbore of the housing;

a plurality of wires, wherein each wire has a proximal end coupled to the actuation head and a distal end opposite the proximal end, wherein each wire is slidingly disposed in one of the circumferentially spaced throughbores of the housing, and wherein the distal ends of the wires forms the expandable member;

wherein (c) comprises moving the wires axially relative to the housing.