Stent delivery system for prevention of kinking, and method of loading and using same

• US 6,858,034 B1
• Filed: 05/18/2000
• Issued: 02/22/2005
• Est. Priority Date: 05/20/1999
• Status: Expired due to Fees

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hijlkema, Lukas J., Friel, Fionnan, McMahon, Michael
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US09/573,273
• Time in Patent Office: 1,741 Days
• Field of Search: 606/108, 606/191, 606/198, 606/151, 606/192, 606/190, 623/1.11, 623/1.12
• US Class Current: 606/108
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A stent delivery system adapted to deliver a compressed stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen. The system houses a compressed stent and includes a pusher and a catheter tip attached to a central core slideably disposed within the pusher. At least one of the pusher distal end and catheter tip proximal end comprises a docking section adapted to releasably engage a limited length of one end of the compressed stent. The docking section may comprise a pocket having a flared end rim that is radially biased outward and adapted to be inwardly compressed to grip the stent end when the docking section is loaded in an outer sheath. Other docking section configurations are also disclosed, such as an insert within the stent, an annular pocket, and/or a set of fingers that grip the stent. A docking pusher and a docking catheter tip having such docking sections are disclosed, as are methods for loading and deploying a stent with a stent delivery system as described herein.

Claims

1. A stent delivery system-adapted to deliver a compressed stent having a proximal end and a distal end to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent delivery system comprising:

a pusher having a distal end located adjacent the stent proximal end; and

a catheter tip having a proximal end located adjacent the stent distal end and attached to a central core slideably disposed within the pusher;

wherein at least one of the pusher distal end and catheter tip proximal end comprises a docking section adapted to releasably engage a limited length of one end of the compressed stent, the docking section comprising an axially flared engagement surface which extends inside a short axial length of the stent.

2. The stent delivery system of claim 1 wherein the docking section comprises an inner set of fingers that extend inside a short axial length of the stent.

3. A pusher adapted to facilitate delivery of a compressed stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the pusher having a distal end comprising a docking section having a flared end rim with an inward protrusion that is radially biased outward relative to the compressed stent and adapted for the inward protrusion to releasably grip a limited length of a proximal end of the stent in pushing engagement therewith when the flared end rim is inwardly compressed to a non-flared diameter.

4. The pusher of claim 3 wherein the docking section is adapted to be inwardly compressed for insertion within a delivery sheath.

5. The pusher of claim 3 wherein the docking section comprises a pocket adapted to contain the stent proximal end inserted therein.

6. The pusher of claim 3 wherein the docking section is integral to the pusher.

7. The pusher of claim 3 wherein the docking section is an attachment to the pusher.

8. A pusher adapted to facilitate delivery of a compressed stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the pusher having a distal end comprising a docking section that is radially biased outward relative to the compressed stent and adapted to releasably engage a limited length of a proximal end of the stent in pushing engagement therewith, wherein the docking section comprises an insert comprising an axially flared engagement surface adapted to be inserted within the stent proximal end.

9. A catheter tip having a proximal end comprising a docking section adapted to releasably engage a limited length of a distal end of a compressed stent during delivery of the stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen wherein the docking section comprises an axially flared engagement surface comprising a reduced diameter section of the catheter tip that extends inside a short axial length of the stent.

10. A method for loading a stent delivery system adapted to deliver a compressed stent having a proximal end and a distal end to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent delivery system comprising a pusher having a distal end located adjacent the stent proximal end, and a catheter tip having a proximal end located adjacent the stent distal end and attached to a central core slideably disposed within the pusher;

the method comprising;

loading at least the compressed stent and a pusher within an outer sheath, including releasably engaging a portion of one of;

the stent proximal end with a pusher docking section that is radially biased outward relative to the compressed stent at the pusher distal end;

the stent distal end with a catheter tip docking section;

or a combination thereof, wherein at least one of the pusher docking section or the catheter tip docking section comprises (a) a flared end rim that is radially biased outward and adapted to be inwardly compressed, the docking section comprising a pocket having an inward protrusion that grips the stent when the docking section is loaded within the outer sheath, or (b) an axially flared engagement surface which extends inside a short axial length of the stent.

11. The method according to claim 10 wherein releasably engaging the portion of the stent proximal end with the docking section at the pusher comprises inserting the stent proximal end within the pocket in the docking section at the pusher.

12. The method according to claim 11 wherein releasably engaging the portion of the stent distal end with the catheter tip docking section comprises inserting the catheter tip docking section inside the stent distal end.

13. A method for deploying a stent in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the method comprising:

a) introducing a pre-loaded stent delivery system into the body lumen, the stent delivery system housing a compressed stent having a proximal end and a distal end and comprising a pusher having a distal end located adjacent the stent proximal end and a catheter tip having a proximal end located adjacent the stent distal end and attached to a central core slideably disposed within the pusher, one or both of the pusher distal end and catheter tip proximal end comprising a docking section that releasably engages a limited length of one end of the compressed stent, and an outer sheath overlying the compressed stent, the pusher, and each docking section, at least one of the pusher docking section or catheter tip docking sections comprising at least one of;

an annular pocket having an inner wall and an outer wall, a pocket having a radial protrusion therein adapted to releasably secure the distal end of the stent within the pocket, or an axially flared engagement surface that extends inside a short axial length of the stent;

b) navigating the stent delivery system to a desired location for deploying the stent; and

c) retracting the outer sheath to deploy the stent from the outer sheath into the desired location and to release the stent from each docking section.

14. The method of claim 13 wherein said at least one docking section comprises the pocket for receiving the stent end, and step (c) comprises evacuating the stent from the pocket.

15. The method of claim 14 wherein said at least one docking section pocket for receiving the stent end has an end rim that is radially biased outward and adapted to be inwardly compressed to grip the stent end when loaded within the outer sheath, and wherein step (c) further comprises the end rim expanding outward during evacuation of the stent from the pocket.

16. The method of claim 13 wherein said at least one docking section comprises a reduced diameter section adapted for inserting within the stent end, and step (c) comprises the stent expanding away from the reduced diameter section.

17. The method of claim 13 wherein the catheter tip comprises one of said docking sections and step (c) further comprises distally advancing the central core and the catheter tip attached thereto to further facilitate release of the stent from the catheter tip docking section.

18. A stent delivery system adapted to deliver a compressed stent from a proximal access location outside the body lumen to a distal deployment location inside a body lumen, the compressed stent having a proximal end and a distal end, the stent delivery system comprising at least one docking section defining a pocket adapted to releasably contain a limited length of one end of the compressed stent, the pocket comprising at least one of:

(a) an annular pocket having an inner wall and an outer wall, and (b) a pocket having a radial protrusion therein adapted to releasably secure the distal end of the stent within the pocket.

19. The stent delivery system of claim 18 wherein the docking section includes a radiopaque marker.

20. The stent delivery system of claim 18 wherein the stent is a self-expanding stent.

21. The stent delivery system of claim 18 in which the pocket comprises a radially biased outward flared end rim having a first configuration in which the end rim has a flared diameter that is greater than a diameter of a remainder of the pocket, and a second configuration in which the end rim is radially compressed to a non-flared diameter that is equal to the diameter of the remainder of the pocket.

22. A method for loading a stent delivery system adapted to deliver a compressed stent from a proximal access location outside the body lumen to a distal deployment location inside a body lumen, the stent having a proximal end and a distal end, the stent delivery system comprising a pusher, a catheter tip attached to a central core slideably disposed within the pusher, at least one docking section defining a pocket adapted to releasably contain a limited length of one end of the compressed stent, and an outer sheath, the docking section pocket comprising at least one of:

(a) an annular pocket having an inner wall and an outer wall, and (b) a pocket having a radial protrusion therein adapted to releasably secure the distal end of the stent within the pocket;

the method comprising loading the compressed stent about the central core between the catheter tip and the pusher, inserting one of the ends of the stent in the pocket, and enclosing at least the stent, central core, pusher, and each docking section within the outer sheath.

23. A method for deploying a stent in a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent having a distal end, a proximal end, a compressed configuration, and an expanded configuration, the method comprising:

a) introducing a pre-loaded stent delivery system into the body lumen, the stent delivery system housing the stent in the compressed configuration and comprising a pusher, a catheter tip attached to a central core slideably disposed within the pusher, at least one docking section defining a pocket that releasably contains one end of the compressed stent, and an outer sheath overlying the compressed stent, the pusher, and each docking section, the docking section pocket comprising at least one of;

(i) an annular pocket having an inner wall and an outer wall, and (ii) a pocket having a radial protrusion therein adapted to releasably secure the distal end of the stent within the pocket;

b) navigating the stent delivery system to a desired location for deploying the stent;

c) retracting the outer sheath to deploy at least a portion of the stent in the expanded configuration in the deployment location; and

d) releasing from each pocket the end of the stent contained in the pocket.

24. A stent delivery system adapted to deliver a compressed stent having a proximal end and a distal end to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the stent delivery system comprising:

a pusher having a distal end located adjacent the stent proximal end;

a catheter tip having a proximal end located adjacent the stent distal end and attached to a central core slideably disposed within the pusher, at least one of the pusher distal end and catheter tip proximal end comprising a docking section adapted to releasably engage a limited length of one end of the compressed stent; and

wherein the docking section comprises a pocket having a radial protrusion therein adapted to releasably secure the stent end within the pocket.

25. A stent delivery system of claim 24 wherein the pocket in the docking section has a flared end rim, the flared end rim being radially biased outward and adapted to be inwardly compressed to grip the stent end when the docking section is loaded in an outer sheath.

26. The stent delivery system of claim 25 wherein the docking section has a bottle-neck geometry when the flared end rim is compressed.

27. The stent delivery system of claim 25 wherein the compressed stent is pinched inward by the flared end rim against the central core.

28. The stent delivery system of claim 25 wherein the docking section comprises a set of fingers.

29. The stent delivery system of claim 25 comprising a pusher docking section having the docking section with the flared end rim that is radially-biased outward and a catheter tip docking section without a radially-biased outward flared end rim.

30. A pusher having a distal end comprising a docking section adapted to releasably engage a limited length of a distal end of a compressed stent during delivery of the stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the docking section comprising a pocket having a radial protrusion therein adapted to releasably secure the proximal end of the stent within the pocket.

31. The pusher of claim 30, wherein the radial protrusion comprises an inward protrusion originating from an outer periphery of the pocket.

32. A catheter tip having a proximal end comprising a docking section adapted to releasably engage a limited length of a distal end of a compressed stent during delivery of the stent to a distal deployment location inside a body lumen from a proximal access location outside the body lumen, the docking section comprising a pocket having a radial protrusion therein adapted to releasably secure the distal end of the stent within the pocket.

33. The catheter tip of claim 32, wherein the radial protrusion comprises an inward protrusion originating from an outer periphery of the pocket.

34. The catheter tip of claim 32 wherein the docking section comprises a flared end rim that is radially biased outward and adapted to be inwardly compressed so that the inward protrusion grips the stent end when inserted within a delivery sheath.

35. The catheter tip of claim 34 wherein the docking section is integral to the catheter tip.

36. The catheter tip of claim 34 wherein the docking section is an attachment to the catheter tip.