Retractable sheath devices, systems, and methods

• US 9,901,715 B2
• Filed: 09/04/2013
• Issued: 02/27/2018
• 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: Cully, Edward H., Heicksen, Peter
• Primary Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US14/018,202
• Publication Number:
  US 20140066898A1
• Time in Patent Office: 1,637 Days
• Field of Search: 60410301, 60410302
• 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 design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only upon necking 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:

an expandable member having an outer surface; and

a sheath comprising a neckable element having a flattened form along the outer surface of the expandable member, the neckable element being a distinctive layer of material which has a width defined by edges of the distinctive layer of material such that when said distinctive layer of material is helically or circumferentially wrapped around said expandable member in an unexpanded state, the edges of said distinctive layer of material are overlapping or touching one another,

wherein when said expandable member expands to the expanded state, the expandable member causes the neckable element to lengthen and the width of the distinctive layer to reduce such that the edges of said distinctive layer of material separate from one another, thereby exposing at least a portion of said outer surface.

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

3. The medical device of claim 2, wherein said tubular form is helically wrapped.

4. The medical device of claim 2, further comprising a coating comprising a therapeutic agent disposed within the lumen of said tubular form.

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

6. The medical device of claim 1, wherein said sheath covers 100% of the outer surface in a collapsed conformation and whereby upon expansion, said sheath covers less than 30% of the outer surface.

7. The medical device of claim 1, wherein said sheath covers 100% of the outer surface in a collapsed conformation and whereby upon expansion, said sheath covers less than 20% of the outer surface.

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

15. The medical device of claim 4, wherein said coating comprises at least one compound selected from the group consisting of benzethonium chloride, PEG, poloxamer, sodium salicylate, and hydroxypropyl-β

-cyclodextrin.

16. The medical device of claim 4, wherein said therapeutic agent is a hydrophilic agent.

17. The medical device of claim 4, wherein said therapeutic agent is a hydrophobic agent.

18. The medical device of claim 17, wherein hydrophobic agent is selected from the group consisting of taxane domain-binding drugs, such as paclitaxel, and rapamycin.

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

20. The medical device of claim 19, wherein a said coating is disposed on said structural layer.

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

inserting a catheter in a vessel, said catheter comprising;

an expandable member comprising a coating with a therapeutic agent; and

a sheath disposed on said expandable member, wherein said sheath comprises at least one neckable element having a flattened form along the expandable member and comprising a strip of material which has a width defined by edges of the strip material such that when said strip of material is helically or circumferentially wrapped around said expandable member in an unexpanded state, the edges of said strip of material are overlapping or touching one another,

wherein said coating is disposed interior to the sheath;

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

expanding the expandable member at the desired location within said vessel such that the expandable member causes said at least one neckable element to lengthen and the width of said strip of material to reduce such that the edges of said strip of material separate from one another, thereby exposing at least a portion of said coating.

9. The method of delivering a therapeutic agent of claim 8, wherein said neckable element comprises a tubular form having a lumen.

10. The method of delivering a therapeutic agent of claim 9, wherein said tubular form is helically wrapped.

11. The method of delivering a therapeutic agent of claim 9, further comprising a second coating disposed within the lumen of said tubular form.

12. The method of delivering a therapeutic agent of claim 8, wherein said sheath covers 100% of the coating in a collapsed conformation and whereby upon expansion, said sheath covers less than 30% of the coating.

13. The method of delivering a therapeutic agent of claim 8, wherein said sheath covers 100% of the coating in a collapsed conformation and whereby upon expansion, said sheath covers less than 20% of the coating.