Controlled porosity devices for tissue treatments, methods of use, and methods of manufacture

Patent metadata

Field	Value
Publication number	US-9808605-B2
Application number	US-201213644251-A
Country	US
Kind code	B2
Filing date	Oct 3, 2012
Priority date	Oct 6, 2011
Publication date	Nov 7, 2017
Grant date	Nov 7, 2017

Abstract

In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

First claim

The invention claimed is:

1. A balloon comprising:
a first porous membrane comprising a first microstructure, the first microstructure being configured to inflate to a nominal dimension in response to introduction of a fluid at an inflation pressure and an inflation rate, and resist fluid flow through the first porous membrane at pressures below a threshold perfusion pressure at which perfusion begins; and
a second porous membrane comprising a second microstructure that is different from the first microstructure, the second porous membrane being configured to withstand a hydrostatic load generated by the first membrane upon inflation,
wherein the threshold perfusion pressure is equal to or greater than the inflation pressure required to achieve the nominal dimension, and
wherein a terminal pressure, at which a maximum working pressure of the balloon is exceeded, is greater than the threshold perfusion pressure, and at the terminal pressure, a perfusion rate of the first porous membrane is about equal to or greater than the inflation rate,
wherein the perfusion rate is volume of fluid flowing through pores of the first porous membrane per unit time and the inflation rate is volume of fluid introduced into the first porous membrane per unit time.

2. The balloon of claim 1 , wherein at least one of the first porous membrane and the second porous membrane comprise expanded polytetrafluoroethylene (ePTFE).

3. The balloon of claim 1 , wherein the first porous membrane comprises a mean flow pore size which is substantially the same before the perfusion and during the perfusion.

4. The balloon of claim 1 , wherein the first porous membrane and the second porous membrane are configured to perfuse a therapeutic agent.

5. The balloon of claim 1 , wherein the balloon is conformable.

6. The balloon of claim 1 , wherein the first porous membrane is disposed at least partially within the second porous membrane.

7. The balloon of claim 1 , further comprising a third porous membrane, wherein the second porous membrane is at least partially within the third porous membrane, wherein the third porous membrane facilitates adhesion to an elongate member.

8. The balloon of claim 1 , wherein a therapeutic agent is disposed on an outer surface of the first porous membrane.

9. The balloon of claim 1 , wherein a size of the balloon in an expanded state is capable of dilating a lumen of a body.

10. The balloon of claim 1 , wherein the balloon is air permeable at a pressure less than the threshold perfusion pressure.

11. The balloon of claim 1 , further comprising a stent and an adhesive agent, wherein the stent is disposed over at least a portion of the balloon and the adhesive agent adheres the stent to the balloon.

12. The balloon of claim 11 , further comprising a solvent, wherein the solvent is capable of perfusing through the first porous membrane and the second porous membrane and dissolving the adhesive agent.

13. The balloon of claim 1 , wherein the first porous membrane is configured to perfuse a first agent and not perfuse a second agent.

14. The balloon of claim 13 , wherein the second agent comprises a contrast agent.

Assignees

• Gore & Ass

Inventors

• Bacino John E
• Campbell Carey V
• Cully Edward H
• Trapp Benjamin M
• Vonesh Michael J

Classifications

• A61L29/146 Primary

  Porous materials, e.g. foams or sponges · CPC title

• A61M25/10 Primary

  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

• F04C2270/0421

  Controlled or regulated · CPC title

• C08L27/18

  Homopolymers or copolymers or tetrafluoroethene · CPC title

• A61L29/041

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