Stent delivery system with hydraulic deployment

• US 7,163,552 B2
• Filed: 10/15/2001
• Issued: 01/16/2007
• Est. Priority Date: 10/13/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Diaz, Juan-Carlos
• Primary Examiner(s): THALER, MICHAEL H
• Application Number:
  US09/978,243
• Publication Number:
  US 20020045929A1
• Time in Patent Office: 1,919 Days
• Field of Search: 623/1.12, 623/1.11, 606/108
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A hydraulic stent and stent graft delivery system utilizing at least two different structural materials to effectuate the easy retention and release of the stent and stent graft, while maintaining structural and sealing integrity for a pressurizable fluid chamber. An anti kinking spacer is disclosed which prevents buckling/kinking of the otherwise unsupported sheath containment section when the catheter assembly is bent such as for insertion a movement to the delivery site. A configuration according to the invention provides a flexible small or dual diameter delivery system that uses fluid pressure within the catheter to retract the stent/stent graft containment sheath and allow the delivery and deployment of the stent/stent graft.

Claims

1. A stent delivery system comprising:

a stent having a compressed stent length;

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent retention section which extends at least said compressed stent length in a first direction along said catheter from a stent plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent plunger for at least said compressed stent length in a second direction, which is opposite said first direction, to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends from said fixed seal mount in said second direction for at least said compressed stent length to a maximum fluid receiving chamber extension length;

a stent containment sheath having a movable seal mount near a proximal end thereof, wherein said stent containment sheath in a pre stent deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent retention section, said stent plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent containment sheath in a post stent deployment position is positioned surrounding a portion of a distal end of said catheter including said stent plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length,

wherein a stent retention portion of said stent containment sheath has an inner surface exposed to a stent containment sheath lumen made of a first material having a lubricious surface quality suitable for easy release of said stent contained therein, said sheath stent retention portion being of the same length as said catheter compressed stent retention section and in said pre stent deployment position extending in said first direction for at least said compressed stent length from said stent plunger,

wherein a stent retraction portion of said stent containment sheath is made of a second material different from said first material against which a first flexible seal structure of a fluid receiving chamber seals, said stent retraction portion of said sheath being of the same length as said catheter sheath retraction section and in said pre stent deployment position extending in said second direction for at least said compressed stent length from said stent plunger, wherein in the post stent deployment position said entire stent retention portion of said sheath remains distal of said fixed seal mount;

wherein said first flexible seal structure is disposed engaged with said fixed seal mount to flexibly seal between said catheter and said stent containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter; and

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter.

12. The stent delivery system as in claim 1 or 11, wherein a wall thickness of said first material of said stent retention portion is different than a wall thickness of said second material of said stent retraction portion.

2. A stent delivery system comprising:

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent retention section which extends at least a compressed stent length in a first direction along said catheter from a stent plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent plunger in a second direction which is opposite said first direction to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends from said fixed seal mount in said second direction to a maximum fluid receiving chamber extension length;

a stent containment sheath having a movable seal mount near an end thereof, wherein said stent containment sheath in a pre stent deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent retention section, said stent plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent containment sheath in a post stent deployment position is positioned surrounding a portion of a distal end of said catheter including said stent plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length, wherein a stent retention portion of said stent containment sheath is made of a first material having a lubricious inner surface suitable for easy release of a stent contained therein, wherein a stent retraction portion of said stent containment sheath is made of a second material having a smooth inner surface against which a first flexible seal structure of a fluid receiving chamber seals;

wherein said first flexible seal structure is disposed engaged with said fixed seal mount to flexibly seal between said catheter and said stent containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter; and

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter, and

an anti-kinking spacer loosely contained within said stent containment sheath and outside said sheath retraction section of said catheter and extending substantially between ends of said sheath retraction section and sized to substantially interfere with the linking of said stent containment sheath at a location adjacent to said anti-kinking spacer when said stent containment sheath containing a portion of said catheter is bent.

3. A stent delivery system as in claim 2, wherein said anti-kinking spacer is a helical spring.

4. A stent delivery system as in claim 3, wherein said anti-kinking spacer is a helical spring having a substantially planar coil shape.

5. A stent delivery system as in claim 4, wherein said anti-kinking spacer is a helical spring having a substantially planar coil shape whose thickness is larger near the central longitudinal axis of the helix and tapers to a smaller thickness near its outer edge.

6. A stent delivery system as in claim 2, wherein said anti-kinking spacer is a series of stacked rings.

7. A stent delivery system as in claims 2, 3, 4, 5, or 6, wherein an inside diameter of said stent containment sheath opposite said compressed stent retention section and the inside diameter of said stent containment sheath opposite said retraction section and said fluid receiving chamber are the substantially the same.

8. A stent delivery system as in claim 7, wherein said catheter has fixed to it a backstop which prevents fluid from being released from the fluid receiving chamber by the stent containment sheath moving so far with respect to the catheter that said fluid receiving chamber is no longer sealed by said first flexible seal structure.

9. A stent delivery system as in claim 2, 3, 4, 5, or 6, wherein an inside diameter of said stent containment sheath opposite said compressed stent retention section and the inside diameter of said stent containment sheath opposite said retraction section and said fluid receiving chamber are substantially different.

10. A stent delivery system as in claim 9, wherein said catheter has fixed to it a backstop which prevents fluid from being released from the fluid receiving chamber by the stent containment sheath moving so far with respect to the catheter that said fluid receiving chamber is no longer sealed by said first flexible seal structure.

11. A stent graft delivery system comprising:

a stent graft having a compressed stent graft length;

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent graft retention section which extends at least said compressed stent graft length in a first direction along said catheter from a stent graft plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends for at least said compressed stent graft length from said stent graft plunger in a second direction, which is opposite said first direction, to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends for at least said compressed stent graft length from said fixed seal mount in said second direction to a maximum fluid receiving chamber extension length;

a stent graft containment sheath having a movable seal mount near an end thereof, wherein said stent graft containment sheath in a pre stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent graft retention section, said stent graft plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent graft containment sheath in a post stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said stent graft plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length,

wherein a stent graft retention portion of said stent graft containment sheath has an inner surface exposed to a stent containment sheath lumen made of a first material having a lubricious surface quality suitable for easy release of said stent graft contained therein, said sheath stent graft retention portion being of the same length as said catheter compressed stent graft retention section and in said pre stent graft deployment position extending in said first direction for at least said compressed stent length from said stent graft plunger,

wherein a stent graft retraction portion of said stent graft containment sheath is made of a second material different from said first material against which a first flexible seal structure of a fluid receiving chamber seals, said stent graft retraction portion of said sheath being of the same length as said catheter sheath retraction section and in said pre stent deployment position extending in said second direction for at least said compressed stent length from said stent graft plunger, wherein in the post stent graft deployment position said entire stent graft retention portion of said sheath remains distal of said fixed seal mount;

wherein said first flexible seal structure is disposed engaged with said fixed seal mount to flexibly seal between said catheter and said stent graft containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter; and

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent graft containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter.

13. The system according to claim 11, wherein said stent graft is a self-expanding stent graft.

14. A stent graft delivery system comprising:

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent graft retention section which extends at least a compressed stent graft length in a first direction along said catheter from a stent graft plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent graft plunger in a second direction which is opposite said first direction to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends from said fixed seal mount in said second direction to a maximum fluid receiving chamber extension length;

a stent graft containment sheath having a movable seal mount near an end thereof, wherein said stent graft containment sheath in a pre stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent graft retention section, said stent graft plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent graft containment sheath in a post stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said stent graft plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length, wherein a stent graft retention portion of said stent graft containment sheath is made of a first material having a lubricious inner surface suitable for easy release of a stent graft contained therein, wherein a stent graft retraction portion of said stent graft containment sheath is made of a second material having a smooth inner surface against which a first flexible seal structure of a fluid receiving chamber seals;

wherein said first flexible seal structure is disposed engaged with said fixed seal mount to flexibly seal between said catheter and said stent graft containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter; and

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent graft containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter, and

an anti-kinking spacer loosely contained within said stent graft containment sheath and outside said sheath retraction section of said catheter and extending substantially between ends of said sheath retraction section and sized to substantially interfere with the kinking of said stent graft containment sheath at a location adjacent to said anti-kinking spacer when said stent graft containment sheath containing a portion of said catheter is bent.

15. A stent graft delivery system as in claim 14, wherein said anti-kinking spacer is a helical spring.

16. A stent graft delivery system as in claim 15, wherein said anti-kinking spacer is a helical spring having a substantially planar coil shape.

17. A stent graft delivery system as in claim 16, wherein said anti-kinking spacer is a helical spring having a substantially planar coil shape whose thickness is larger near the central longitudinal axis of the helix and tapers to a smaller thickness near its outer edge.

18. A stent graft delivery system as in claim 14, wherein said anti-kinking spacer is a series of stacked rings.

19. A stent graft delivery system as in claims 14, 15, 16, 17, or 18, wherein an inside diameter of said stent graft containment sheath opposite said compressed stent graft retention section and the inside diameter of said stent graft containment sheath opposite said retraction section and said fluid receiving chamber are the substantially the same.

20. A stent graft delivery system as in claim 19, wherein said catheter has fixed to it a backstop which prevents fluid from being released from the fluid receiving chamber by the stent graft containment sheath moving so far with respect to the catheter that said fluid receiving chamber is no longer sealed by said first flexible seal structure.

21. A stent graft delivery system as in claim 14, 15, 16, 17, or 18, wherein an inside diameter of said stent graft containment sheath opposite said compressed stent graft retention section and the inside diameter of said stent graft containment sheath opposite said retraction section and said fluid receiving chamber are substantially different.

22. A stent graft delivery system as in claim 21, wherein said catheter has fixed to it a backstop which prevents fluid from being released from the fluid receiving chamber by the stent graft containment sheath moving so far with respect to the catheter that said fluid receiving chamber is no longer sealed by said first flexible seal structure.

23. A stent delivery system comprising:

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent retention section which extends at least a compressed stent length in a first direction along said catheter from a stent plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent plunger in a second direction which is opposite said first direction to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends from said fixed seal mount in said second direction to a maximum fluid receiving chamber extension length;

a stent containment sheath having a movable seal mount near an end thereof, wherein said stent containment sheath in a pre stent deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent retention section, said stent plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent containment sheath in a post stent deployment position is positioned surrounding a portion of a distal end of said catheter including said stent plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length;

a first flexible seal structure disposed engaged with said fixed seal mount and flexibly sealing between said catheter and said stent containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter;

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent containment sheath moves with respect to said catheter; and

,

an anti-kinking spacer loosely contained within said stent containment sheath and outside said sheath retraction section of said catheter and extending substantially between ends of said sheath retraction section and sized to substantially interfere with the kinking of said stent containment sheath at a location adjacent to said anti-kinking spacer when said stent containment sheath containing a portion of said catheter is bent.

24. A stent graft delivery system comprising:

a catheter having a guidewire lumen at least partially therethrough, and having a fluid pressurizing lumen therein separate from said guidewire lumen, said fluid pressurizing lumen extending between a proximal end thereof and a fluid opening at a distal end of said catheter;

said catheter having a compressed stent graft retention section which extends at least a compressed stent graft length in a first direction along said catheter from a stent graft plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent graft plunger in a second direction which is opposite said first direction to a fixed seal mount fixed to said catheter, said catheter further containing a fluid receiving chamber section containing said fluid opening, said fluid receiving chamber section extends from said fixed seal mount in said second direction to a maximum fluid receiving chamber extension length;

a stent graft containment sheath having a movable seal mount near an end thereof, wherein said stent graft containment sheath in a pre stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent graft retention section, said stent graft plunger, said sheath retraction section, said fixed seal mount, and a minimum fluid receiving chamber extension length, wherein said stent graft containment sheath in a post stent graft deployment position is positioned surrounding a portion of a distal end of said catheter including said stent graft plunger, said sheath retraction section, said fixed seal mount, and a substantial portion of said maximum fluid receiving chamber extension length;

a first flexible seal structure disposed engaged with said fixed seal mount and flexibly sealing between said catheter and said stent graft containment sheath at a first end of said fluid receiving chamber, said first flexible seal structure maintains engagement with said fixed seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter;

a second flexible seal structure disposed engaged with said movable seal mount and flexibly sealing between said catheter and said stent graft containment sheath at an end opposite said first end of said fluid receiving chamber section and maintaining engagement with said movable seal mount as said fluid receiving chamber is pressurized and said stent graft containment sheath moves with respect to said catheter; and

,

an anti-kinking spacer loosely contained within said stent graft containment sheath and outside said sheath retraction section of said catheter and extending substantially between ends of said sheath retraction section and sized to substantially interfere with the kinking of said stent graft containment sheath at a location adjacent to said anti-kinking spacer when said stent graft containment sheath containing a portion of said catheter is bent.

25. A method for hydraulically retracting a stent containment sheath comprising the steps of:

providing a catheter having fixed seal fixed to a fixed seal mount thereon, with a fluid receiving chamber section on one side of said fixed seal and an anti kinking spacer on a second side of said with a plunger disposed at the end of said anti-kinking spacer opposite the fixed seal with a stent in a compressed pre deployment position disposed around a stent retention section of the catheter beyond the plunger;

surrounding a portion of a distal end of said catheter with a containment sheath such sheath containing said fixed seal and said fixed seal mount and said antikinking spacer and said plunger and said stent in said pre deployment position, said containment sheath being sized to seal against said fixed seal of said catheter and including a movable seal which moves with the containment catheter and seals against said catheter to establish a fluid receiving chamber between the catheter, the containment sheath and the fixed seal and the movable seal; and

injecting fluid into a lumen of said catheter in communication with a fluid opening in said fluid receiving chamber, such pressurization causing said retraction sheath to retract with respect to said catheter and uncover the stent for deployment.

26. The method of claims 25, wherein the stent containment sheath is constructed from at least two different diameter tubes.

27. The method of claim 25, wherein the stent containment sheath is constructed from at least two different materials having substantially different surface lubricity.

28. A stent delivery system comprising:

a catheter having a guidewire lumen at least partially therethrough;

said catheter having a compressed stent retention section which extends at least a compressed stent length in a first direction along said catheter from a stent plunger engaged with said catheter at a location near a distal end of said catheter, said catheter having a sheath retraction section which extends from said stent plunger in a second direction which is opposite said first direction;

a stent containment sheath, wherein said stent containment sheath in a pre stent deployment position is positioned surrounding a portion of a distal end of said catheter including said compressed stent retention section, said stent plunger, and said sheath retraction section, and

an anti-kinking spacer loosely contained within said stent containment sheath and around said sheath retraction section of said catheter and extending substantially between ends of said sheath retraction section and sized to substantially interfere with the kinking of said stent containment sheath at a location adjacent to said anti-kinking spacer when said stent containment sheath containing a portion of said catheter is bent, wherein said anti-kinking spacer is a helical spring having windings with substantially planar opposing surfaces, each winding having a tapered thickness from a larger thickness near a central longitudinal axis of the helix to a smaller thickness at an outer radial edge of the winding such that the windings have frustum-like cross-sections.

29. A stent delivery system as in claim 28, wherein when said anti-kinking spacer is unbent a distance between said substantially planar opposing surfaces of adjacent windings is greatest at said outer radial edges of said coils.