Removable covers for drug eluting medical devices

Patent metadata

Field	Value
Publication number	US-11679240-B2
Application number	US-202016783612-A
Country	US
Kind code	B2
Filing date	Feb 6, 2020
Priority date	Oct 3, 2014
Publication date	Jun 20, 2023
Grant date	Jun 20, 2023

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 medical device comprising:
an expandable medical device; and
a tubular sheath surrounding at least a portion of the expandable medical device,
wherein the tubular sheath is configured to split upon a proximally directed application of tension being applied to a distal end of the tubular sheath, and
wherein the tubular sheath is configured such that a split portion of the tubular sheath is adapted to be everted inwardly and removed from surrounding the expandable medical device by extending between the tubular sheath and the expandable medical device.

2. The medical device of claim 1 , further comprising an activation line coupled to the distal end of the tubular sheath, the activation line extending between the tubular sheath and the expandable medical device.

3. The medical device of claim 2 , wherein the sheath is configured to split into a first sheath segment and a second sheath segment, and wherein the activation line includes a first portion attached to the first sheath segment and a second portion attached to the second sheath segment, the first and second sheath segments being adapted to be everted inwardly and removed from surrounding the expandable medical device by extending between the tubular sheath and the expandable medical device.

4. The medical device of claim 1 , wherein the tubular sheath has an inner surface and the expandable medical device has an outer surface, and wherein the split portion of the tubular sheath is adapted to be everted inwardly and removed from surrounding the expandable medical device by extending between the inner surface of the tubular sheath and the outer surface of the expandable medical device.

5. The medical device of claim 3 , wherein the first sheath segment is removable from surrounding the expandable medical device prior to the second sheath segment being removed from surrounding the expandable medical device.

6. The medical device of claim 3 , wherein a length of the first portion of the activation line is shorter than a length of the second portion of the activation line.

7. The medical device of claim 2 , wherein the expandable medical device is a first balloon, the medical device further comprising a second balloon having a higher compliance than a compliance of the first balloon, the second balloon being in fluid communication with the first balloon, wherein upon inflation of the second balloon, tension is applied to the activation line.

8. A medical device comprising:
an expandable medical device; and
a tubular sheath surrounding at least a portion of the expandable medical device, the tubular sheath comprising a first sheath layer and a second sheath layer,
wherein the tubular sheath is configured to split upon a proximally directed application of tension being applied to a distal end of the tubular sheath, and
wherein the tubular sheath is configured such that a split portion of the tubular sheath is adapted to be everted inwardly and removed from surrounding the expandable medical device by extending between the first and second sheath layers.

9. The medical device of claim 8 , further comprising an activation line coupled to the distal end of the tubular sheath, the activation line extending between the first and second sheath layers.

10. The medical device of claim 9 , wherein the sheath is configured to split into a first sheath segment and a second sheath segment, and wherein the activation line includes a first portion attached to the first sheath segment and a second portion attached to the second sheath segment, the first and second sheath segments being adapted to be everted inwardly and removed from surrounding the expandable medical device by extending between the first and second sheath layers.

11. The medical device of claim 10 , wherein the first sheath segment is removable from surrounding the expandable medical device prior to the second sheath segment being removed from surrounding the expandable medical device.

12. The medical device of claim 10 , wherein a length of the first portion of the activation line is shorter than a length of the second portion of the activation line.

13. The medical device of claim 8 , wherein the expandable medical device is one of a balloon and a stent.

14. The medical device of claim 9 , wherein the expandable medical device is a first balloon, the medical device further comprising a second balloon having a higher compliance than a compliance of the first balloon, the second balloon being in fluid communication with the first balloon, wherein upon inflation of the second balloon, tension is applied to the activation line.

15. The medical device of claim 8 , wherein the tubular sheath comprises an extruded polymeric tube.

16. The medical device of claim 8 , wherein the tubular sheath comprises a wrapped polymeric material.

17. The medical device of claim 8 , wherein the tubular sheath comprises a distensible and highly oriented polymeric material.

18. The medical device of claim 8 , wherein the tubular sheath comprises ePTFE.

19. The medical device of claim 9 , wherein a proximal end of the tubular sheath is secured to an elongate member.

Assignees

• Gore & Ass

Inventors

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

Classifications

• A61F2/97

  the outer sleeve being splittable · CPC title

• A61M2025/0681

  Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube · CPC title

• A61F2002/9583

  Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve · CPC title

• A61M2025/105

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

• C08L27/18

  Homopolymers or copolymers or tetrafluoroethene · CPC title