Occlusion Systems

Patent metadata

Field	Value
Publication number	US-2021330333-A1
Application number	US-202117242740-A
Country	US
Kind code	A1
Filing date	Apr 28, 2021
Priority date	Apr 28, 2020
Publication date	Oct 28, 2021
Grant date	—

Abstract

An occlusion device with particular utility in occlusion of left atrial appendages is described. The occlusion device utilizes an inflatable balloon comprising a proximal portion to inflate with an inflation fluid delivered by an outer catheter body and conform to a shape of the left atrial appendage and a distal portion to fill with an adhesive delivered by an inner catheter body. The distal portion of the inflatable balloon sticks to the tissue wall of the left atrial appendage. The outer catheter body is configured to position the inner catheter body inside the outer catheter body.

First claim

What is claimed is:

1 . An occlusion system for occluding a treatment site, comprising:
an outer catheter having an elongated body and at least one lumen extending therethrough; an inner catheter disposed radially within the outer catheter; a balloon assembly releasably connected to a distal end of the outer catheter via a detachment mechanism; and, an adhesive-absorbing membrane located at a distal end of the balloon assembly; the adhesive-absorbing membrane configured to absorb a predetermined volume of adhesive delivered through the inner catheter and to expose the adhesive along an outer surface of the adhesive membrane.

2 . The occlusion system of claim 1 , wherein the adhesive-absorbing membrane is configured to absorb or contain about 0.1 to 1 ml of adhesive.

3 . The occlusion system of claim 1 , wherein the adhesive-absorbing membrane has a thickness within an inclusive range of about 0.001 inch to about 0.003 inch.

4 . The occlusion system of claim 1 , wherein the adhesive-absorbing membrane is composed of a 13 denier PET fiber woven to have about 120 courses per inch.

5 . The occlusion system of claim 1 , wherein pores of the adhesive-absorbing membrane have sizes in a range of about 3 microns-10 microns.

6 . The occlusion system of claim 1 , wherein the adhesive-absorbing membrane comprises a plurality of fibers forming a series of interlocking loops.

7 . The occlusion system of claim 1 , wherein the balloon assembly is configured to limit external exposure of the adhesive to only the distal end of the balloon assembly.

8 . The occlusion system of claim 1 , wherein the balloon assembly comprises a proximal portion configured to be inflated with inflation fluid, and a distal portion configured to accept adhesive.

9 . The occlusion system of claim 8 , wherein the adhesive-absorbing membrane of the distal portion of the balloon assembly is attached over a depression at a distal end of the proximal portion of the balloon assembly.

10 . The occlusion system of claim 8 , wherein the inner catheter extends into the distal portion of the balloon assembly.

11 . The occlusion system of claim 10 , further comprising a valve assembly positioned within the balloon assembly so as to separate the proximal portion from the distal portion of the balloon assembly, the valve assembly comprising a first valve configured to seal around the outer catheter and a second valve configured to seal around the inner catheter.

12 . The occlusion system of claim 11 , wherein the at least one lumen of the outer catheter comprises an inflation lumen sized and configured to allow passage of inflation fluid into the proximal portion of the balloon assembly while the inner catheter is positioned within the inflation lumen.

13 . An occlusion system for occluding a treatment site in a heart, comprising:
an outer catheter having an elongated body and an inflation lumen extending therethrough; and, a balloon assembly releasably connected to a distal end of the outer catheter via a detachment mechanism; the balloon assembly comprising an inflatable proximal portion configured to receive inflation fluid and a distal portion configured to accept adhesive; the balloon assembly further comprising a first valve preventing release of the inflation fluid outside of the balloon assembly, and a second valve preventing release of the inflation fluid into the distal portion.

14 . The occlusion system of claim 13 , wherein the first valve and the second valve are arranged in a linear passage.

15 . The occlusion system of claim 14 , wherein the first valve is configured to engage the outer catheter and wherein the second valve is configured to engage an inner catheter positioned within the inflation lumen of the outer catheter.

16 . The occlusion system of claim 15 , wherein the inner catheter configured to deliver adhesive to the distal portion and wherein the outer catheter is configured to deliver inflation fluid through the inflation lumen while the inner catheter is positioned within the inflation lumen.

17 . The occlusion system of claim 13 , wherein the distal portion comprises an adhesive-absorbing membrane configured to absorb a predetermined volume of adhesive and expose the adhesive on an outer surface of the adhesive-absorbing membrane.

18 . The occlusion system of claim 13 , wherein the adhesive-absorbing membrane is woven to have a thickness within an inclusive range of about 0.001 inch to about 0.003 inch and has a pore size within an inclusive range of about 3-10 microns.

19 . A method for occluding blood flow in a left atrial appendage in a heart of a patient, comprising:
advancing a balloon assembly into a left atrial appendage; inflating a first portion of the balloon assembly via an inflation lumen from an outer catheter; delivering adhesive to a second portion of the balloon assembly; absorbing the adhesive with an adhesive-absorbing membrane connected to the second portion of the balloon assembly so that the adhesive is exposed on an outer surface of the adhesive-absorbing membrane; and, detaching the outer catheter from the balloon assembly.

20 . The method of claim 19 , further comprising preventing inflation fluid from the first portion of the balloon assembly into the second portion of the balloon assembly.

Assignees

• Terumo Corp

Inventors

• Gray Brian
• Dasnurkar Anup
• Walker Maricela
• Martel Michael
• Kamiuchi Hiroki

Classifications

• A61M2025/1054

  having detachable or disposable balloons · CPC title

• A61B17/12136 Primary

  Balloons · CPC title

• A61B2017/12095

  Threaded connection · CPC title

• A61B2017/00893

  pharmaceutically effective · CPC title

• A61B17/00491

  Surgical glue applicators · CPC title