Stent delivery system having a fibrous matrix covering with improved stent retention

• US 8,500,687 B2
• Filed: 03/22/2011
• Issued: 08/06/2013
• Est. Priority Date: 09/25/2008
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ehrenreich, Kevin J., Newhauser, Richard, von Oepen, Randolf, Stankus, John
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US13/069,020
• Publication Number:
  US 20110230948A1
• Time in Patent Office: 868 Days
• Field of Search: 604/102.01, 604103-10303, 60410305-10306, 60410309-10311, 604/96.01, 604/912, 604915-921, 623 111- 112, 606191-192, 606194-195, 606/198
• US Class Current: 604/103
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The present invention provides an intraluminal stent delivery catheter device having improved stent retention. Particularly, the present invention is directed to a catheter having an expandable member and a fibrous matrix positioned over the expandable member and a stent mounted on the outer surface of the fibrous matrix. The fibrous matrix provides mechanical interface for improved stent retention, delivery and deployment.

Claims

1. A stent delivery system comprising:

a catheter shaft having a proximal end portion and a distal end portion;

an expandable member provided at the distal end portion of the shaft, the expandable member having a delivery condition and a deployed condition;

a matrix of fiber elements disposed on at least a portion of the expandable member to define a continuous covering substantially free of openings when in the delivery condition; and

an expandable stent mounted on the expandable member in the delivery condition with the matrix of fiber elements disposed therebetween, the stent including a plurality of strut elements with interstices defined therebetween.

2. The stent delivery system of claim 1, wherein the matrix of fiber elements protrudes outwardly into the interstices of the stent.

3. The stent delivery system of claim 2, wherein the plurality of strut elements have side surfaces facing the interstices defined therebetween, the matrix of fiber elements engaging the side surfaces.

4. The stent delivery system of claim 2, wherein the matrix of fiber elements protrudes outwardly through the interstices beyond an outer surface of the stent.

5. The stent delivery system of claim 4, wherein the matrix of fiber elements protrudes outwardly through the interstices to engage an outer surface of the stent.

6. The stent delivery system of claim 1, wherein the matrix of fiber elements is adhered to a surface of the stent.

7. The stent delivery system of claim 1, wherein the fiber elements of the matrix of fiber elements are electrospun fibers.

8. The stent delivery system of claim 1, wherein the fiber elements of the matrix of fiber elements are melt-blown fibers.

9. The stent delivery system of claim 1, wherein the fiber elements of the matrix of fiber elements comprise a polymer selected from the group consisting of polyamides, polyurethanes, fluoropolymers, polyolefins, polyimides, polyimines, (methyl)acrylic polymers, polyesters, and co-polymers thereof.

10. The stent delivery system of claim 1, wherein the fiber elements of the matrix of fiber elements have a cross-sectional diameter of from about 2.5 micrometers to about 10 micrometers.

11. The stent delivery system of claim 1, wherein the matrix of fiber elements is a sleeve disposed over an outer surface of the expandable member.

12. The stent delivery system of claim 11, wherein at least a portion of the sleeve is attached to the outer surface of the expandable member.

13. The stent delivery system of claim 11, wherein at least a portion of the sleeve is attached to the catheter shaft proximate the expandable member.

14. The stent delivery system of claim 11, wherein the sleeve has a length greater than a length of the expandable member.

15. The stent delivery system of claim 1, wherein a beneficial agent is disposed on at least one portion of the expandable member or the stent.

16. The stent delivery system of claim 15, wherein the beneficial agent is selected from the group consisting of anti-proliferative, anti-inflammatory, antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic, antibiotic, antiallergic and antioxidant compounds and combinations thereof.

17. A stent delivery system comprising:

a catheter shaft having a proximal end portion and a distal end portion;

an expandable member provided at the distal end portion of the shaft, the expandable member formed at least in part from a matrix of fiber elements to define a continuous surface substantially free of openings when in the delivery condition, the expandable member having a delivery condition and a deployed condition; and

an expandable stent mounted on the expandable member in the delivery condition, the stent including a plurality of strut elements with interstices defined therebetween.

18. A method for securing a stent onto a stent delivery system, the method comprising:

providing an intraluminal catheter device including a catheter shaft having a proximal end portion and a distal end portion with an expandable member disposed at the distal end portion of the shaft, the expandable member having a delivery condition and a deployed condition;

disposing a matrix of fiber elements on at least a portion of the expandable member to define a continuous covering substantially free of openings when in the delivery condition;

providing an expandable stent having a plurality of strut elements with interstices defined therebetween; and

mounting the expandable stent on the expandable member in the delivery condition with the matrix of fiber elements disposed therebetween.

19. The method of claim 18, wherein disposing the matrix of fiber elements on at least a portion of the expandable member includes electrospinning fiber elements on the expandable member.

20. The method of claim 18, wherein disposing the matrix of fiber elements on at least a portion of the expandable member includes forming the matrix of fiber elements as a sleeve and positioning the sleeve over an outer surface of the expandable member.

21. The method of claim 20, further comprising attaching at least a portion of the sleeve to the outer surface of the expandable member.

22. The method of claim 20, further comprising attaching at least a portion of the sleeve to the catheter shaft proximate the expandable member.

23. The method of claim 18, wherein mounting the expandable stent includes crimping the stent until the matrix of fiber elements protrudes outwardly into the interstices of the stent.

24. The method of claim 23, wherein the plurality of strut elements have side surfaces facing the interstices defined therebetween, the matrix of fiber elements engaging the side surfaces.

25. The method of claim 23, wherein the matrix of fiber elements protrudes outwardly through the interstices beyond an outer surface of the stent.

26. The method of claim 23, wherein the matrix of fiber elements protrudes outwardly through the interstices to engage an outer surface of the stent.

27. The method of claim 18, further comprising adhering the matrix of fiber elements to a surface of the stent.

28. The method of claim 27, wherein adhering is performed with solvent.

29. The method of claim 27, wherein adhering is performed with heat.

30. The method of claim 18, further comprising applying a beneficial agent to at least a portion of the expandable member or the stent.

31. The method of claim 30, wherein the beneficial agent is selected from the group consisting of anti-proliferative, anti-inflammatory, antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic, antibiotic, antiallergic and antioxidant compounds and combinations thereof.

32. A method for securing a stent onto a stent delivery system, the method comprises:

providing an intraluminal catheter device including a catheter shaft having a proximal end portion and a distal end portion with an expandable member disposed at the distal end portion of the shaft, the expandable member having a delivery condition and a deployed condition, the expandable member formed at least in part from a matrix of fiber elements to define a continuous surface substantially free of openings when in the delivery condition,

providing an expandable stent having a plurality of strut elements with interstices defined therebetween; and

mounting the expandable stent on the expandable member in the delivery condition.