Removable covers for drug eluting medical devices

Patent metadata

Field	Value
Publication number	US-10569063-B2
Application number	US-201514872439-A
Country	US
Kind code	B2
Filing date	Oct 1, 2015
Priority date	Oct 3, 2014
Publication date	Feb 25, 2020
Grant date	Feb 25, 2020

Abstract

The present disclosure includes an expandable medical device and outer sheath combination. The outer sheath is capable of being split to form multiple sheath sections that may be peeled back to expose a portion or all of the expandable medical device. The medical device, as well as the outer sheath, may include one or more therapeutic agents for delivery to a treatment area within a patient.

First claim

What is claimed is:

1. A system comprising:
a radially expandable tubular sheath surrounding at least a portion of an expandable medical device, the sheath including a first sheath segment and a second sheath segment, and a first split line defined between the first and second sheath segments; and
an activation line comprising a first portion attached to the first sheath segment and a second portion attached to the second sheath segment, the first portion having a shorter length than the second portion when the sheath is unsplit,
wherein the sheath is configured to split along the first split line to form the first sheath segment and the second sheath segment by applying tension to the activation line such that each of the first and second sheath segments are configured to be peeled back from surrounding the expandable medical device, and
wherein the first sheath segment is configured to be peeled back from surrounding a first portion of the expandable medical device prior to the second sheath segment being peeled back from surrounding a second portion of the expandable medical device.

2. The system of claim 1 , wherein the expandable medical device is a balloon.

3. The system of claim 2 , wherein the balloon comprises a drug coating.

4. The system of claim 1 , wherein the sheath is hydrophobic.

5. The system of claim 1 , wherein the sheath is hydrophilic.

6. The system of claim 1 , wherein the sheath comprises an extruded polymeric tube.

7. The system of claim 1 , wherein the sheath comprises a wrapped polymeric material.

8. The system of claim 1 , wherein the sheath comprises a distensible and highly oriented polymeric material.

9. The system of claim 8 , wherein the polymeric material comprises ePTFE.

10. The system of claim 1 , wherein upon applying tension to the activation line, the first sheath segment is configured to be pulled towards a proximal end of the expandable medical device.

11. The system of claim 1 , where upon applying tension to the activation line, the first sheath segment is pulled towards a distal end of the expandable medical device.

12. The system of claim 1 , wherein the first sheath segment is configured to be removable from the expandable medical device prior to the second sheath segment being peeled back.

13. The system of claim 1 , wherein the first sheath segment is configured to split along the first split line and a second split line which are parallel to a longitudinal axis of the expandable medical device.

14. The system of claim 1 , wherein the activation line configured such that tension can be applied to the activation line manually.

15. The system of claim 2 , wherein the balloon is a first balloon, the system further comprising a second balloon having a higher compliance than a compliance of the first balloon and in fluid communication with the first balloon, wherein upon inflation of the second balloon, tension is applied to the activation line.

16. The system of claim 1 , wherein a distal end of the first sheath segment and a distal end of the second sheath segment are secured to an elongate member.

17. The system of claim 16 , wherein the first sheath segment and the second sheath segment are secured to the elongate member by a mechanical means that is configured to activate upon expansion of the expandable medical device.

18. The system of claim 1 , wherein the sheath comprises a first layer and a second layer, and wherein as tension is applied to the activation line, the first sheath segment is configured to evert between the first layer of the sheath and the second layer of the sheath.

19. The system of claim 1 , wherein the activation line comprises a ribbon positioned between an outer surface of the expandable medical device and an inner surface of the sheath.

20. The system of claim 1 , wherein the expandable medical device is a stent.

21. The system of claim 2 , wherein a portion of an inside layer of the sheath is textured.

22. The system of claim 21 , wherein a portion of the inside layer of the sheath comprises a drug coating.

23. The system of claim 1 further comprising a plurality of radially expandable tubular sheaths surrounding at least a portion of the expandable medical device.

Assignees

• Gore & Ass

Inventors

• Cully Edward H
• Duncan Jeffrey B
• Heicksen Peter
• Koenig Joseph B
• Kustusch Jeffrey J

Classifications

• A61M2025/105

  having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes · CPC title

• A61F2/954

  for placing stents or stent-grafts in a bifurcation · CPC title

• A61M2025/1081

  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 title

• A61M25/1011

  Multiple balloon catheters · CPC title

• A61F2/958 Primary

  Inflatable balloons for placing stents or stent-grafts · CPC title