Blow molded composite devices and methods

Patent metadata

Field	Value
Publication number	US-2016106961-A1
Application number	US-201514882330-A
Country	US
Kind code	A1
Filing date	Oct 13, 2015
Priority date	Oct 16, 2014
Publication date	Apr 21, 2016
Grant date	—

Abstract

The present disclosure is directed toward a composite balloon comprising a layer of material having a porous microstructure (e.g., ePTFE or expanded polyethylene) and a thermoplastic polymeric layer useful for medical applications. The layers of the composite balloons become adhered through a stretch blow-molding process. Methods of making and using such composite balloons are also described amongst others.

First claim

What is claimed is:

1 . A medical balloon comprising a balloon wall defining a chamber and comprising a layered material, wherein the layered material comprises a first polymer layer adhered to a fluoropolymer layer comprising a porous microstructure, wherein layers are in overlying relationship to each other and the fluoropolymer layer is an outermost layer.

2 . The medical balloon of claim 1 , wherein the first polymer layer is mechanically adhered to the second polymer layer and the mechanical adhesion is created during the blow molding process.

3 . The medical balloon of claim 1 , wherein the layered material comprises a seamless polymeric layer and wherein the porous polymeric layer is an outermost layer and wherein the seamless polymeric layer is selected from the group comprising compliant, semi-compliant and non-compliant material.

4 . The medical balloon of claim 3 , wherein the mechanical adhesion is created during a blow molding process.

5 . The medical balloon of claim 1 , wherein the layered material defines at least one recessed region on the outer surface, and wherein the at least one recessed region comprises a region of more collapsed pores in the porous polymeric layer relative to a non-recessed region.

6 . The medical balloon of claim 5 , wherein the recessed region is formed through a blow molding process.

7 . The medical balloon of claim 5 , wherein the at least one recessed region comprises a porous polymeric layer thickness that is 90% or less relative to the porous polymeric layer thickness of the non-recessed region.

8 . The medical balloon of claim 5 , wherein the layered material comprises the polymeric layer having the porous microstructure at least partially adhered to a second polymeric layer such that the porous polymeric layer is the outermost layer.

9 . The medical balloon of claim 1 , wherein the porous polymeric layer is an expanded fluoropolymer.

10 . The medical balloon of claim 1 , wherein the first polymer layer is a polyamide layer.

11 . The medical balloon of claim 1 , wherein the first or seamless polymeric layer is a thermoplastic polymer.

12 . The medical balloon of claim 1 , wherein the first polymeric layer is seamless.

13 . The medical balloon of claim 1 , wherein the medical balloon is semi-compliant or non-compliant.

14 . The medical balloon of claim 1 , wherein the medical balloon is compliant.

15 . The medical balloon of claim 1 , wherein an interface between the layers consists of the material of the first polymer and the material of the second polymer or fluoropolymer.

16 . The medical balloon of claim 1 , wherein the polymeric layers are capable of separating with 1 N/m of average kinetic force in a 157 degree Peel Test.

17 . The medical balloon of claim 1 , wherein the polymeric layers are capable of separating with 3 N/m of average kinetic force in a 157 degree Peel Test.

18 . The medical balloon of claim 1 , wherein the polymeric layers are capable of separating with the occurrence of material failure at a force that is less than the force of the adhesion failure in a 157 degree Peel Test.

19 . The medical balloon of claim 1 , wherein the medical balloon is inflatable to a pressure greater than 20 bar for a medical balloon of 4 to 8 mm in diameter.

20 . The medical balloon of claim 1 , further comprising an endovascular medical device disposed about the balloon.

21 . The medical balloon of claim 1 , further comprising a therapeutic agent coated on at least a portion of the outer surface of the medical balloon.

22 . The medical balloon of claim 1 , wherein the balloon surface defines a plurality of recesses and protrusions.

23 . The medical balloon of claim 22 , wherein the plurality of recesses and protrusions are striated recesses and protrusions.

24 . The medical balloon of claim 23 , wherein the striations are longitudinally oriented.

25 . The medical balloon of claim 1 , wherein the balloon surface defines a plurality of recesses and protrusions within the working length of the balloon and wherein the protrusions covers about 30% to 70% of the total balloon surface area within the working length.

26 . The medical balloon of claim 22 , wherein the maximum width of the plurality of protrusions is between 0.1 mm to 1 mm.

27 . The medical balloon of claim 1 , wherein the porous polymeric layer is anisotropic.

28 . The medical balloon of claim 27 , wherein the anisotropic porous polymeric layer is oriented such that the balloon wall has a lower tensile strength in the longitudinal direction than the radial direction.

29 . The medical balloon of claim 27 , wherein the anisotropic porous polymeric layer is oriented such that the balloon wall has a higher tensile strength in the longitudinal direction than the radial direction.

30 . The medical balloon of claim 1 , where the porous polymer layer is isotropic.

31 . A method of making a medical balloon comprising radially expanding, in a mold, a thermoplastic balloon preform and a fluoropolymeric tubular member comprising a porous microstructure, wherein the tubular member is disposed about the balloon preform and applying heat to the radially expanded balloon preform and the fluoropolymeric tubular member at a temperature at or above the glass transition temperature of the thermoplastic balloon preform but below the melt temperature of the thermoplastic balloon preform to form a layered balloon body.

32 . The method of claim 31 , wherein the portions of the outermost polymeric layer and the underlying layer within the mold become mechanically adhered while in a radially expanded state.

33 . The method of claim 31 , wherein the mold has an inner surface that defines one or more recesses and wherein the formed balloon body comprises one or more recessed regions on the outer surface formed by a section of the tubular member being forced against a non-recessed section of the inner surface of the mold while in a radially expanded state.

34 . A method of making a medical balloon comprising radially expanding, in a mold, a thermoplastic balloon preform and applying heat to the radially expanded balloon preform at a temperature at or above the glass transition temperature of the thermoplastic balloon preform but below the melt temperature of the thermoplastic balloon preform to form a balloon body; removing the balloon body from the mold; mechanically or manually pleating the balloon body; mechanically or manually folding the balloon body to a nominal diameter; inserting the balloon body into a fluoropolymeric tubular member comprising a porous microstructure, wherein the fluoropolymeric tubular member is disposed about the balloon body forming a composite structure; placing said composite structure into a mold; applying heat and pressure to said composite structure forming a composite balloon; removing said composite balloon from the mold.

35 . The method of claim 34 , wherein the portions of the outermost polymeric layer and the underlying layer within the mold become mechanically adhered while in a radially expanded state.

36 . The method of claim 34 , wherein the balloon body is bonded to a catheter prior to the insertion of the balloon body into a

Assignees

• Gore & Ass

Inventors

• Broyles Michael R
• Cully Edward H
• Heicksen Peter
• Koenig Joseph B
• Maulding Matthew E
• Mazzarese Kenneth

Classifications

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• B29K2627/18

  PTFE, i.e. polytetrafluoroethylene {, e.g. ePTFE, i.e. expanded polytetrafluoroethylene} · CPC title

• A61L29/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61M2025/1031

  Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface · CPC title

• A61L29/041 Primary

  obtained by reactions only involving carbon-to-carbon unsaturated bonds · CPC title