Inflatable balloon and cover

Patent metadata

Field	Value
Publication number	US-2017340465-A1
Application number	US-201715678685-A
Country	US
Kind code	A1
Filing date	Aug 16, 2017
Priority date	Mar 14, 2013
Publication date	Nov 30, 2017
Grant date	—

Abstract

The present disclosure describes implantable medical devices comprising covers, such as a balloon cover. Such devices can comprise a first layer of a porous polymeric material, such as ePTFE, surrounded by layers of a porous polymeric material having an imbibed elastomer, such as polyurethane. The cover can be used to assist in deployment of an expandable implant, such as a stent-graft, within the body of the patient.

First claim

What is claimed is:

1 . A method of manufacturing a cover comprising:
imbibing a portion of a first surface of a porous polymeric sheet with an elastomer to form an imbibed zone, wherein a remaining portion of the first surface of the porous polymeric sheet that is not imbibed forms a non-imbibed zone, the imbibed zone and the non-imbibed zone forming a partially imbibed sheet; wrapping the partially imbibed sheet on a mandrel to form a first polymeric layer; and wrapping the partially imbibed sheet on the mandrel to form at least one composite layer comprising a porous polymer imbibed with an elastomeric component.

2 . The method of claim 1 , wherein the partially imbibed sheet comprises ePTFE.

3 . The method of claim 1 , wherein the partially imbibed sheet is wrapped such that the non-imbibed zone contacts a second surface of the partially imbibed sheet and the imbibed zone contacts the second surface of the partially imbibed sheet.

4 . The method of claim 1 , wherein the partially imbibed sheet possesses a direction of higher matrix tensile strength, and wherein a direction of wrapping is substantially perpendicular to the direction of higher matrix tensile strength of the partially imbibed sheet.

5 . The method of claim 1 , wherein the partially imbibed sheet possesses a direction of higher matrix tensile strength, and wherein the direction of higher matrix tensile strength of the partially imbibed sheet is helically oriented about the mandrel.

6 . The method of claim 1 , wherein the partially imbibed sheet possesses a direction of higher matrix tensile strength, and wherein the direction of higher matrix tensile strength of the partially imbibed sheet is circumferentially oriented about the mandrel.

7 . The method of claim 1 , wherein the partially imbibed sheet comprises an isotropic porous polymer.

8 . The method of claim 1 , wherein a depth of the imbibed zone is at least equal to a perimeter of the mandrel.

9 . The method of claim 1 , wherein a depth of the imbibed zone is at least twice a perimeter of the mandrel.

10 . The method of claim 1 , wherein a depth of the non-imbibed zone is greater than a perimeter of the mandrel.

11 . The method of claim 1 , wherein the partially imbibed sheet is wrapped around the mandrel at least ten (10) times.

12 . The method of claim 1 , further comprising the steps of:
coaxially surrounding a balloon with the cover; and thermally bonding at least a portion of the cover to the balloon.

13 . The method of claim 12 , wherein the balloon comprises at least one pleat prior to coaxially surrounding the balloon with the cover.

14 . The method of claim 1 , further comprising the steps of:
thermally treating the first polymeric layer and the at least one composite layer comprising a porous polymer imbibed with an elastomeric component to form the cover; allowing the cover to cool; removing the cover from the mandrel; coaxially surrounding a balloon with the cover; inflating the balloon and the cover to a working pressure; and pleating the balloon and the cover while deflating the balloon and the cover.

15 . The method of claim 14 , wherein the working pressure is about 6 psi.

16 . The method of claim 14 , wherein the step of coaxially surrounding the balloon with the cover further comprises coaxially surrounding a pleated balloon with the cover.

17 . The method of claim 14 , wherein the step of coaxially surrounding the balloon with the cover further comprises coaxially surrounding a non-pleated balloon with the cover.

18 . The method of claim 14 , further comprising the steps of rolling at least one pleat of the balloon and the cover in a radial direction.

Assignees

• Gore & Ass

Inventors

• Kanjickal Deenu G
• Nickerson James J
• Triebes Thomas G

Classifications

• A61M25/10

  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}) · CPC title

• A61F2002/9583

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

• A61M2025/1075

  having a balloon composed of several layers, e.g. by coating or embedding · CPC title

• A61M25/1029

  Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril · CPC title