RETRACTABLE SHEATH DEVICES, SYSTEMS, AND METHODS

• US 20140066897A1
• Filed: 09/04/2013
• Published: 03/06/2014
• Est. Priority Date: 09/05/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Campbell, Carey V., Cleek, Robert L., Cully, Edward H., Heicksen, Peter, Holland, Theresa A., Kranzler, Thane L., Li, Mei, Steinhaus, Bruce M., Trapp, Benjamin M., Triebes, Thomas G., Vonesh, Michael J.
• Granted Patent: US 10,173,038 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61F 2/962 having an outer sleeve
• 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 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The invention is directed to delivery medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises retractable sheath comprising neckable elements. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and a retractable outer sheath with a selectively permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during retraction of the outer sheath, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Claims

1. A medical device comprising:

a. an expandable member having an outer surface; and

b. a sheath comprising a neckable element disposed around said expandable member;

c. wherein when said expandable member is expanded, said neckable element elongates and reduces in width, thereby exposing at least portion of said outer surface.

2. The medical device of claim 1, wherein said neckable element is at least one of helically, longitudinally, or circumferentially oriented about said expandable member.

3. The medical device of claim 1, wherein said neckable element comprises a tubular form having a lumen.

4. The medical device of claim 3, wherein said tubular form is helically wrapped.

5. The medical device of claim 3, further comprising a coating comprising a therapeutic agent disposed within the lumen of said tubular form.

6. The medical device of claim 1, further comprising a coating comprising a therapeutic agent disposed around said expandable member.

7. The medical device of claim 5, wherein said neckable element comprises a permeable microstructure that limits bulk transfer of said therapeutic agent and allows hydration.

14. The medical device of claim 1, wherein said sheath is treated with a wetting agent.

15. The medical device of claim 14, wherein said wetting agent is selected from the group consisting of heparin coatings, polyvinyl alcohol, polyethylene glycol, polypropylene glycol, dextran, agarose, alginate, polyacrylamide, polyglycidol, poly(vinyl alcohol-co-ethylene), poly(ethyleneglycolco-propyleneglycol), poly(vinyl acetate-co-vinyl alcohol), poly(tetrafluoroethylene-co-vinyl alcohol), poly(acrylonitrile-co-acrylamide), poly(acrylonitrile-co-acrylic acid-co-acrylamidine), polyacrylic acid, poly-lysine, polyethyleneimine, polyvinyl pyrrolidone, polyhydroxyethylmethacrylate, and polysulfone, and their copolymers, either alone or in combination.

16. The medical device of claim 14, wherein said wetting agent is polyvinyl alcohol.

17. The medical device of claim 1, wherein said sheath wets out.

18. The medical device of claim 1, wherein said sheath undergoes wetting as a result of a preinsertion preparatory procedure.

19. The medical device of claim 1, wherein said sheath undergoes macroscopic wetting in a vessel while said expandable member is in the unexpanded state and being delivered to a desired location within a vessel.

20. The medical device of claim 1, wherein said sheath undergoes microscopic wetting in a vessel while said expandable member is in the unexpanded state and being delivered to a desired location within a vessel.

21. The medical device of claim 1, wherein fluid external to said sheath is allowed to flow through said sheath and contact said therapeutic agent.

22. The medical device of claim 1, wherein said expandable member is a medical balloon.

23. The medical device of claim 1, wherein said sheath comprises a tetrafluoroethylene copolymer comprising a hydrophilic monomer.

24. The medical device of claim 1, wherein said sheath comprises at least one material from the group consisting of a fluoropolymer, polyamides, polyurethane, polyolefins, polyesters, polyglycolic acid, poly lactic acid, and trimethylene carbonate.

25. The medical device of claim 1, wherein said sheath comprises a fluoropolymer comprising a selectively permeable microstructure.

26. The medical device of claim 1, wherein said sheath comprises ePTFE.

33. The medical device of claim 1, wherein said expandable member further comprises a structural layer.

34. The medical device of claim 33, wherein said structural layer comprises said coating and therapeutic agent.

8. A medical device comprising:

a. an expandable member;

b. a coating comprising a therapeutic agent disposed around said expandable member;

c. a retractable outer sheath disposed around said coating and forming a permeable microstructure that limits unintended transfer of therapeutic agent and allows hydration; and

d. wherein when said retractable outer sheath is retracted, at least a portion of a hydrated coating is exposed.

9. The medical device of claim 8, wherein said retractable outer sheath comprises at least one of a dilatable slit or dilatable pore configured to dilate upon expansion of said expandable member.

10. The medical device of claim 8, wherein said retractable outer sheath is coupled to a retraction member.

11. The medical device of claim 8, wherein said retractable outer sheath comprises a frangible film configured to split open upon expansion of said expandable member.

12. The medical device of claim 8, wherein said retractable outer sheath comprises at least two adjacent film elements configured to separate upon expansion of said expandable member.

27. The medical device of claim 8, wherein said coating comprises a hydrophilic component.

28. The medical device of claim 27, wherein said hydrophilic component in said coating raises the solubility point of a hydrophobic therapeutic agent.

29. The medical device of claim 8, wherein said coating comprises at least one compound selected from the group consisting of benzethonium chloride, PEG, poloxamer, sodium salicylate, and hydroxypropyl-β

-cyclodextrin.

30. The medical device of claim 8, wherein said therapeutic agent is a hydrophilic agent.

31. The medical device of claim 8, wherein said therapeutic agent is a hydrophobic agent.

32. The medical device of claim 31, wherein hydrophobic agent is selected from the group consisting of taxane domain-binding drugs, such as paclitaxel, and rapamycin.

13. A method of delivering a therapeutic agent to a desired location within a vessel or an implanted endoprosthesis comprising:

a. inserting a catheter in a vessel, said catheter comprising

i. an expandable member comprising a coating with a therapeutic agent;

ii. a sheath disposed around said expandable member, wherein said sheath has a selectively permeable microstructure that limits particulation of said coating during tracking but allows said coating to be at least partially hydrated;

iii. wherein said coating and therapeutic agent are disposed interior to the sheath;

b. advancing said catheter to a desired location within said vessel; and

c. expanding the expandable member at the desired location within said vessel, and wherein said sheath retracts and exposes a hydrated or partially hydrated coating.