Introducer sheath with retainer

• US 20020068899A1
• Filed: 11/28/2001
• Published: 06/06/2002
• Est. Priority Date: 12/06/2000
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Tashjian, Paul
• Granted Patent: US 6,764,464 B2
• Time in Patent Office: Days
• US Class Current: 604/104
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A surgical introducer sheath comprising a first member having a first longitudinally extending lumen dimensioned to receive a surgical instrument therethrough, a second member having a second longitudinally extending lumen dimensioned to receive the first member, and a retainer adjacent a distal portion of the second member movable from a first retracted position to a second extended position to limit proximal movement of the introducer sheath. Rotational movement of the second member in a first direction moves the retainer to the extended position and rotational movement of the second member in a second direction moves the retainer to a retracted position.

Claims

1. A surgical vascular introducer sheath comprising:

a first member having a first longitudinally extending lumen configured and dimensioned to receive a surgical instrument therethrough;

a second member having a second longitudinally extending lumen configured and dimensioned to receive the first member; and

a retainer adjacent a distal portion of the second member, the retainer movable from a first retracted position to a second extended position to limit proximal movement of the introducer sheath, the retainer movable in response to movement of the second member.

2. The introducer sheath of claim 1, wherein rotational movement of the second member in a first direction moves the retainer to the extended position and rotational movement of the second member in a second direction moves the retainer to the retracted position.

3. The introducer sheath of claim 2, wherein the second member is substantially fixed longitudinally during rotation.

4. The introducer sheath of claim 2, wherein the retainer comprises a flap having a substantially curved configuration in the extended position.

5. The introducer sheath of claim 4, wherein the flap includes an opening to allow blood flow therethrough when in the extended position.

6. The introducer sheath of claim 2, wherein a first portion of the retainer extends from the second member and a second portion of the retainer is attached to the first member.

7. The introducer sheath of claim 1, further comprising a second retainer movable between retracted and extended positions.

8. The introducer sheath of claim 1, wherein the first and second members each have a plurality of side holes for blood flow for dialysis.

9. The introducer sheath of claim 8, wherein rotational movement of the second member in a first direction moves the retainer to the extended position and rotational movement of the second member in a second direction moves the retainer to a retracted position, wherein the side holes of the first and second members are out of alignment when the retainer is in the retracted position and the side holes are moved into alignment when the second member is rotated to move the retainer into the extended position.

10. The introducer sheath of claim 2, further comprising a locking mechanism for maintaining the retainer in the extended position.

11. The introducer sheath of claim 10, wherein the locking mechanism comprises a locking pin slidable within a locking groove, the groove having a narrowed section to retain the pin.

12. The introducer sheath of claim 10, wherein the locking mechanism comprises a post movable within a locking groove, the locking groove having a radial region and first and second axial regions.

13. The introducer sheath of claim 11, further comprising a housing, wherein a proximal portion of the first and second members are positioned within the housing, the locking groove being positioned on the housing and the locking pin extending from the second member.

14. The introducer sheath of claim 1, wherein the retainer comprises a flap formed integrally with the second member.

16. The surgical sheath of claim 15, wherein the tubular member includes an inner and outer tubular member and the limiting means comprises a flap movable to the second position in response to rotational movement of the outer tube.

17. The surgical sheath of claim 15, wherein the first and second members each have a plurality of side holes for blood flow for dialysis, wherein the side holes of the first and second members are out of alignment when the retainer is in the retracted position and the side holes are moved into alignment when the second member is rotated to move the retainer into the extended position.

18. The surgical sheath of claim 15, wherein the tubular member includes an inner and outer tube, and the limiting means comprises first and second flaps movable to the extended position in response to rotational movement of the outer tube.

20. The surgical sheath of claim 19, wherein the retainer is movable to the blocking position in response to rotation of the outer tubular member.

21. The surgical sheath of claim 20, further comprising a locking element for locking the retainer in the blocking position.

22. The surgical sheath of claim 21, wherein the first and second holes of the inner and outer tubular members are rotatable into alignment by rotation of the outer tubular member to align the holes to enable blood flow for dialysis.

23. The surgical sheath of claim 22, further comprising a locking mechanism for maintaining the retainer in the blocking position, the locking mechanism including a locking pin slidable within a locking groove having a narrowed section to retain the pin, the locking pin extending from the second member and the locking groove being positioned on a housing which receives the inner and outer tubular members.

24. The surgical sheath of claim 22, further comprising a locking mechanism for maintaining the retainer in the blocking position, the locking mechanism including a locking post slidable within a locking groove, the locking post extending from the second member and the locking groove being positioned on a cap mounted to the inner tubular member.

25. The introducer sheath of claim 23, further comprising a seal member positioned on the inner tube to provide a fluid seal between the inner and outer tubular members.

27. The method of claim 26, wherein the step of rotating the outer tubular member to move the retainer from the retracted position to the extended position aligns holes in the introducer sheath to allow blood flow for dialysis.

15. A surgical sheath for providing a passageway for instrumentation into a vessel comprising:

a tubular member having a lumen extending longitudinally therein configured and dimensioned for receiving surgical instruments therethrough, the tubular member having a distalmost tip; and

means spaced proximally from the distalmost tip for limiting proximal movement of the sheath with respect to the vessel, the limiting means being movable from a first position to a second position extending laterally with respect to the tubular member and enabling blood flow therethrough in the second position.

19. A surgical sheath for providing a passageway for instrumentation into a vessel comprising:

an outer tubular member having a first hole in a side wall;

an inner tubular member disposed within the outer tubular member and having a passageway for receiving surgical instruments therethrough and having a second hole in a side wall;

a retainer positioned at a distal portion of the outer tubular member and extendable radially with respect to the outer tubular member, the retainer being movable from a non-blocking position substantially flush with the outer tubular member to a blocking position extending radially outwardly from the outer tubular member.

26. A method for retaining a surgical introducer sheath comprising the steps of:

inserting an introducer having inner and outer tubular members and a retainer into body tissue;

rotating the outer tubular member of the introducer sheath to move the retainer from a retracted position to an extended position so the retainer extends radially outwardly with respect to the introducer sheath,

introducing a surgical instrument into the introducer sheath;

performing a surgical step with the surgical instrument;

withdrawing the surgical instrument, the retainer limiting proximal movement of the introducer sheath during withdrawal of the surgical instrument; and

rotating the outer tubular member of the introducer sheath to return the retainer to its retracted position.