Double sheath deployment system

• US 6,945,990 B2
• Filed: 08/16/2003
• Issued: 09/20/2005
• Est. Priority Date: 08/16/2003
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Greenan, Trevor
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Houston, Elizabeth
• Application Number:
  US10/641,825
• Publication Number:
  US 20050038495A1
• Time in Patent Office: 766 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.2, 623/1.23, 606/108, 606/194, 604/264
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

A stent-graft deployment system (10) includes a stent-graft (15), a flexible catheter tip (12) attached to a catheter shaft (25), a retractable primary sheath (20) containing the stent-graft in a first constrained small diameter configuration around the catheter shaft near the flexible tip. The stent-graft deployment system further includes a flexible secondary sheath (14) disposed within the retractable primary sheath and also containing the stent-graft, wherein when the primary sheath is removed from around the stent-graft, the flexible secondary sheath contains the stent-graft in a second constrained small diameter configuration around the catheter shaft near the flexible tip. The removal of the secondary sheath releases the stent-graft from a radial constraint so that stent-graft deployment may proceed.

Claims

1. A stent-graft deployment system, comprising:

a stent-graft;

a catheter, comprising;

a catheter shaft having a tip;

a retractable primary sheath and a retractable flexible secondary sheath, wherein the primary sheath is disposed about the secondary sheath;

wherein in a predeployed condition said stent-graft is contained within the flexible secondary sheath and retained in a first constrained small diameter configuration by the primary sheath, wherein when said primary sheath is retracted from around said stent-graft, said flexible secondary sheath retains said stent-graft in a second constrained small diameter configuration larger than said first constrained small diameter configuration and has substantially reduced resistance to bending as compared to when said primary sheath is covering said stent-graft, wherein removal of the secondary sheath releases the stent-graft from a radial constraint so that stent-graft deployment occurs as the secondary sheath releases.

2. The stent graft deployment system as in claim 1, wherein removal of the retractable secondary sheath occurs through a secondary sheath retraction member connected to a proximal end of said retractable flexible secondary sheath, such that retraction of the secondary sheath retraction member causes a proximal end of said retractable flexible secondary sheath to be pulled along a catheter longitudinal axis toward a proximal end of said catheter, where pulling of the proximal end of said retractable flexible secondary sheath creates a force to tension the retractable flexible sheath to cause a retraction of the secondary sheath along the catheter longitudinal axis thereby causing progressive deployment of said stent graft from the distal end of the catheter.

3. A stent-graft deployment system, comprising:

a stent-graft and

a catheter, comprising;

a flexible catheter tip attached to a catheter shaft;

a retractable primary sheath containing said stent-graft in a first constrained small diameter configuration around said catheter shaft near said flexible tip; and

a flexible secondary sheath disposed within said retractable primary sheath and also containing said stent-graft, wherein when said primary sheath is removed from around said stent-graft, said flexible secondary sheath contains said stent-graft in a second constrained small diameter configuration larger than said first constrained small diameter configuration around said catheter shaft near said flexible tip, wherein removal of the secondary sheath releases the stent-graft from a radial constraint so that stent-graft deployment may proceed.

4. The stent-graft deployment system of claim 3, wherein the second constrained diameter is slightly larger than said first constrained small diameter configuration.

5. The stent-graft deployment system of claim 3, wherein the retractable primary sheath is comprised of a semi-rigid material such as PTFE.

6. The stent-graft deployment system of claim 3, wherein the secondary sheath is selected from the group of materials comprising woven materials such as fabrics, porous materials such as ePTFE, polymers such as ultra thin walled polymers, and flexible materials such as PET.

7. A stent-graft deployment system, comprising:

a retractable primary sheath having a first constrained diameter configuration;

a secondary sheath having a second constrained diameter configuration, larger than said first constrained diameter configuration selectively disposed within the retractable primary sheath, wherein the secondary sheath is more flexible than the retractable primary sheath;

a stent-graft initially retained within the secondary sheath and maintained in the first constrained diameter configuration by the primary sheath, wherein the stent-graft is at least partially maintained within the second constrained diameter configuration when the primary sheath is removed from around the stent-graft, wherein removal of the secondary sheath releases the stent-graft from a radial constraint so that stent-graft deployment proceeds.

8. The stent-graft deployment system of claim 7, wherein the system further comprises a taper tip at a distal end of the stent-graft deployment system.

9. The stent-graft deployment system of claim 7, wherein the system further comprises a retention means for retaining the stent-graft.

10. The stent-graft deployment system of claim 7, wherein the secondary sheath is a retractable secondary sheath.

11. The stent-graft deployment system of claim 7, wherein the retractable primary sheath is comprised of a semi-rigid material such as PTFE.

12. The stent-graft deployment system of claim 7, wherein the secondary sheath is selected from the group of materials comprising woven materials such as fabrics, porous materials such as ePTFE, Ultra thin walled polymers, and flexible materials such as PET.

13. The stent-graft deployment system of claim 7, wherein the second constrained diameter is slightly larger than the first constrained diameter configuration.

14. The stent-graft deployment system of claim 7, wherein the secondary sheath is selectively disposed within the retractable primary sheath by axially retracting the primary sheath relative to the secondary sheath.

15. A stent-graft deployment system, comprising:

a semi-rigid sheath;

a flexible secondary sheath coaxially arranged within the semi-rigid sheath when the semi-rigid sheath is in a non-retracted position;

a stent-graft collapsed within the flexible secondary sheath;

an arrangement for retracting the semi-rigid sheath and exposing the flexible secondary sheath, wherein the stent-graft expands to an intermediate deployment position holding the stent graft at a diameter larger than the diameter of the stent graft within said semi-rigid sheath when the semi-rigid sheath is retracted;

a second arrangement for retracting the flexible secondary sheath, wherein the stent-graft is able to expand towards complete deployment as the flexible secondary sheath is retracted.

16. The stent-graft deployment system of claim 15, wherein the stent-graft system further comprises a taper tip.

17. The stent-graft deployment system of claim 15, wherein the arrangement for retracting the semi-rigid sheath comprises a hub coupled to the to the semi-rigid sheath enabling relative axial movement of the semi-rigid sheath over a remainder of the stent-graft deployment system.

18. The stent-graft deployment system of claim 15, wherein the arrangement for retracting the flexible secondary sheath comprises moving an inner tube coupled to the flexible secondary sheath that enables relative axial movement of the flexible secondary sheath relative to the semi-rigid sheath.

19. A stent-graft deployment system comprising:

a catheter shaft;

a stent-graft disposed about the catheter shaft;

a retractable secondary sheath, which takes the form of an elongated tube, disposed about the catheter shaft, and adapted to retain the stent-graft in an intermediate pre-deployed position;

a retractable primary sheath, which takes the form of an elongated tube, disposed about at least a portion of the secondary sheath and the stent-graft, and adapted to retain the stent-graft in a compressed pre-deployed position, wherein when the primary sheath is retracted from about the stent-graft, the stent-graft expands to the intermediate pre-deployed position larger than said compressed pre-deployed position and is thereafter retained by the secondary sheath until the secondary sheath is retracted to deploy the stent-graft;

a first handle coupled to an end of the primary sheath and adapted to enable relative movement between the primary sheath and the secondary sheath; and

a second handle coupled to an end of the secondary sheath and adapted to enable relative movement between the secondary sheath and the catheter shaft.

20. The stent-graft deployment system defined in claim 19, wherein the retractable primary sheath is comprised of a semi-rigid material such as PTFE.

21. The stent-graft deployment system defined in claim 19, wherein the secondary sheath is selected from the group of materials comprising woven materials such as fabrics, porous materials such as ePTEE, ultra thin walled polymers, and flexible materials such as PET.

22. The stent-graft deployment system defined in claim 19, wherein the intermediate pre-deployed position is slightly larger than the compressed pre-deployed position.