SYSTEMS AND METHODS FOR DELIVERY OF A MEDICAL DEVICE

• US 20130150945A1
• Filed: 12/03/2012
• Published: 06/13/2013
• Est. Priority Date: 12/08/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Hagaman, Logan R., Crawford, Daniel A.
• Granted Patent: US 9,364,359 B2
• Time in Patent Office: Days
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires

Abstract

In various embodiments, the medical device delivery system described herein can be configured to position and deliver a medical device in a body lumen. The medical device delivery system can comprise an elongate member, a medical device and a leash. During deployment, the medical device can be tethered to the catheter by the leash, to stabilize and prevent unwanted shifting of the medical device as it deploys at the treatment site.

Claims

1. A medical device delivery system comprising:

a catheter;

an expandable device disposed on an end of the catheter;

a sleeve disposed around the expandable device and having a first configuration to retain the expandable device in a first outer peripheral dimension, the sleeve having a second configuration to allow expansion of the expandable device to a second outer peripheral dimension larger than the first outer peripheral dimension;

a release line extending through and maintaining the sleeve in the first configuration, and being removable to allow actuation of the sleeve to the second configuration; and

a leash line forming a releasable interconnection between the catheter and the device, the leash line having a loop for receiving the release line therethrough and retaining the interconnection between the catheter and the expandable device after removal of the release line from the sleeve.

2. The medical device delivery system of claim 1, wherein the leash line extends through an aperture in the expandable device to form the loop that receives the release line therethrough to retain the expandable device after retraction of the release line.

3. The medical device delivery system of claim 2, wherein the aperture is formed in an end of the expandable device.

4. The medical device delivery system of claim 3, wherein the expandable device includes a graft and a stent, the stent having an apex, the leash line extending through the apex to form the loop.

5. The medical device delivery system of claim 1, wherein the catheter further comprises an olive, and wherein the olive comprises an attachment point configured to receive the leash line.

6. The medical device delivery system of claim 5, wherein the olive defines a second passage, which at least partially aligns with a first passage defined by the catheter.

7. The medical device of claim 6, wherein the release line passes through the first passage and the second passage.

8. The medical device delivery system of claim 6, wherein the olive and the leash line are withdrawn through the first passage after deployment of the expandable device.

9. A leash line, comprising:

a plurality of segments defined by knots; and

a loop configured to couple to a medical device, wherein the loop is provided at a first segment defined between a first knot and a second knot, and wherein the loop passes through an apex of a medical device.

10. The leash line of claim 9, wherein the leash line is configured to decouple from an end of a medical device delivery system.

11. The leash line of claim 10, wherein the medical device delivery system comprises a catheter, and wherein the leash line is withdrawn with the catheter in response to the medical device being deployed at a treatment site.

12. The leash line of claim 9, wherein the leash line is configured to reduce longitudinal movement of the medical device during deployment at a treatment site.

13. The leash line of claim 9, wherein a release line is configured to freely slide through the loop.

14. The leash line of claim 9, further comprising a sleeve and a release line, and wherein the medical device is deployed to a treatment site in a deployment configuration and expanded at the treatment site in response to removing the release line from the sleeve.

15. The leash line of claim 14, wherein the loop is decoupled from the medical device in response to the medical device being expanded.

16. The leash line of claim 9, wherein the medical device is constrained by a deployment sheath, and wherein the deployment sheath is actuated by a release line.

17. A method of deploying a medical device, comprising:

providing a medical device delivery system, comprising a catheter, a medical device, a release line, and a leash line, wherein the medical device is delivered to a treatment site by the catheter, and wherein the leash line couples the medical device to the catheter;

deploying the medical device from the catheter at the treatment site, wherein the leash line couples to the medical device at two points such that the medical device is stabilized at the treatment site by the leash line;

retracting the release line through a loop in the leash line and through the catheter, wherein the medical device expands to a treatment configuration in response to retraction of the release line; and

decoupling the loop of the leash line from the expanded medical device.

18. The method of claim 17, further comprising:

releasing a deployment sheath in response to retracting the release line, wherein the deployment sheath surrounds a portion of the medical device and is configured to constrain the medical device for delivery to the treatment site.

19. The method of claim 17, wherein the medical device is at least one of a stent and a stent graft, and wherein the medical device comprises an apex that is capable of receiving the loop.

20. The method of claim 17, wherein the leash line comprises a plurality of knots defining segments, and wherein the loop is defined in a first segment.

21. A medical device delivery system comprising:

a catheter;

an expandable device disposed on an end of the catheter;

a sheath disposed around the expandable device and having a first configuration to retain the expandable device in a first outer peripheral dimension, the sleeve having a second configuration to allow expansion of the expandable device to a second outer peripheral dimension larger than the first outer peripheral dimension;

a leash line forming a releasable connection between the catheter and the device that limits axial displacement of the expandable device relative to the catheter during deployment deployment of the expandable device and that is releasable after deployment of the expandable device.

22. The medical device as set forth in claim 21, wherein the sheath is formed from a flexible fluoropolymer film.

23. The medical device as set forth in claim 22, wherein the sheath is formed from ePTFE.

24. The medical device as set forth in claim 23, wherein the sheath includes a plurality of holes for receiving a release line therethrough to releasably maintain the sheath in the first configuration.

25. The medical device as set forth in claim 21, wherein the sheath is axially displaceable between the first configuration and second configuration.