Vascular introducer sheath with retainer

• US 20020068898A1
• 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 6,589,214 B2
• Time in Patent Office: Days
• US Class Current: 604/104
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument

Abstract

The present invention provides a surgical vascular introducer sheath comprising first and second members and a retainer. The first member has a first longitudinally extending lumen configured and dimensioned to receive a surgical instrument therethrough and a first side opening in an outer wall in fluid communication with the first lumen. The second member has a second longitudinally extending lumen and a second side opening in fluid communication with the second lumen, wherein at least a portion of the first member is positioned within the second lumen of the second member. The retainer is positioned at a distal portion of the first member and is movable from a first retracted position to a second extended position to limit proximal movement of the introducer in response to movement of the first member. Rotational movement of the first member in a first direction moves the retainer to the extended position and rotational movement of the first member in a second direction moves the retainer to a retracted position and moves the first and second side openings from a non-aligned position to an aligned position.

Claims

1. A surgical vascular introducer sheath comprising:

a first member having a first outer wall, a first side opening in the outer wall, and a first longitudinally extending lumen, the first lumen configured and dimensioned to receive a surgical instrument therethrough and the first side opening being in fluid communication with the first lumen;

a second member having a second outer wall, a second longitudinally extending lumen, and a second side opening in the outer wall in fluid communication with the second lumen, at least a portion of the first member being positioned within the second lumen of the second member; and

a retainer positioned at a distal portion of the first 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 first member, wherein movement of the first member in a first direction moves the retainer to the extended position and movement of the first member in a second direction moves the retainer to a retracted position, and movement of the first member in the first direction to extend the retainer moves the first and second side openings from a non-aligned position to an aligned position.

2. The introducer sheath of claim 1, wherein the retainer is moved between its extended and retracted positions in response to rotational movement of the first member.

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

4. The introducer sheath of claim 1, wherein the retainer is moved between its extended and retracted positions in response to longitudinal movement of the first member.

5. The introducer sheath of claim 2, wherein the retainer comprises a flap having a curved configuration and an opening for blood flow therethrough in the extended position.

6. The introducer sheath of claim 2, further comprising a second retainer extending from the first member and movable between retracted and extended positions in response to rotational movement of the first member to limit proximal movement of the introducer sheath.

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

8. The introducer sheath of claim 7, wherein the locking mechanism comprises a locking pin slidable within a locking groove, the groove having a narrowed section to retain the pin.

9. The introducer sheath of claim 8, 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 first member.

10. The introducer sheath of claim 9, wherein the housing has an internal keyway slot to receive a key extending from the second member to prevent rotation of the second member.

11. The surgical sheath of claim 2, wherein the retainer comprises a spring-like member movable to the second position in response to rotational movement of the first member, the second member having an opening to allow movement of the spring-like member to the second extended position.

13. The surgical sheath of claim 12, wherein the retainer comprises a flap having a curved configuration and an opening in the extended position to allow blood flow therethrough.

14. The surgical sheath of claim 12, wherein the retainer comprises a spring-like member movable to the second position in response to rotational movement of the first tubular member, the first tubular member having an opening to allow movement of the spring-like member to the second extended position.

15. The surgical sheath of claim 12, wherein the first and second members each have at least one side hole wherein the holes are in alignment when the retainer is in the extended position to allow blood flow for dialysis.

16. The surgical sheath of claim 15, further comprising a locking mechanism for maintaining the retainer in the extended 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 first tubular member and the locking groove being positioned on a housing which receives the first and second tubular members.

17. The introducer sheath of claim 16, wherein a proximal portion of the first and second tubular members are positioned within the housing, the housing having an internal keyway slot to receive a key extending from the second tubular member to prevent rotation of the second member.

19. The method of claim 18, wherein the step of rotating the inner tubular member of the introducer sheath to move the retainer from the retracted position to the extended position aligns holes in the introducer sheath to allow blood flow therethrough for dialysis.

20. The method of claim 19, further comprising the step of locking the retainer in the extended position.

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

a first tubular member having a first lumen extending longitudinally therein configured and dimensioned for receiving surgical vascular instruments therethrough;

a second tubular member having a second lumen extending longitudinally therein, at least a portion of the first tubular member positioned within the second lumen of the second tubular member; and

a retainer extendable from the first tubular member and spaced proximally from a distalmost tip of the first tubular member, the retainer limiting proximal movement of the sheath with respect to the vessel to prevent dislodgement of the sheath from the vessel incision, the retainer being movable from a first retracted position to a second extended position extending laterally with respect to the tubular member in response to rotational movement of the first tubular member.

18. A method for preventing dislodgement of a vascular introducer sheath through a vascular incision when the introducer sheath is positioned through the incision with a distal portion extending into the vessel, the method comprising the steps of:

inserting an introducer sheath through an incision in the vessel wall so a distal portion of the sheath extends into the vessel,

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

introducing a surgical vascular instrument into the introducer sheath;

performing a surgical step in a vascular procedure with the surgical instrument;

withdrawing the surgical instrument, the retainer preventing proximal movement of the introducer sheath through the vessel incision during withdrawal of the surgical instrument; and

rotating the inner tubular member of the introducer sheath to return the retainer to its retracted position; and

removing the introducer sheath from the vessel through the vascular incision.