Occlusion systems

Patent metadata

Field	Value
Publication number	US-12011174-B2
Application number	US-202117242740-A
Country	US
Kind code	B2
Filing date	Apr 28, 2021
Priority date	Apr 28, 2020
Publication date	Jun 18, 2024
Grant date	Jun 18, 2024

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 releasably connected to a distal end of the outer catheter via a detachment mechanism; and,
an adhesive-absorbing membrane located at a distal portion of the balloon; 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-absorbing 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 a distal portion of the balloon comprises a depression, wherein the adhesive-absorbing membrane is positioned over the depression, and wherein the balloon is configured to limit external exposure of the adhesive to only the depression of the balloon.

8. The occlusion system of claim 1 , wherein the inner catheter extends into the distal portion of the balloon.

9. The occlusion system of claim 8 , further comprising a valve assembly positioned within the balloon so as to separate an interior of the balloon from the adhesive-absorbing membrane, 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.

10. The occlusion system of claim 9 , 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 interior of the balloon while the inner catheter is positioned within the inflation lumen.

11. 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 releasably connected to a distal end of the outer catheter via a detachment mechanism; the balloon comprising an inflatable portion configured to receive inflation fluid and a distal depression configured to accept adhesive;
a first valve preventing release of the inflation fluid outside of the inflatable portion of the balloon, and a second valve preventing release of the inflation fluid into the distal depression.

12. The occlusion system of claim 11 , wherein the first valve and the second valve are arranged in a linear passage.

13. The occlusion system of claim 12 , 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.

14. The occlusion system of claim 13 , wherein the inner catheter is configured to deliver adhesive to the distal depression 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.

15. The occlusion system of claim 11 , wherein the distal depression comprises an adhesive-absorbing membrane configured to absorb a volume of an adhesive and expose the adhesive on an outer surface of the adhesive-absorbing membrane.

16. The occlusion system of claim 15 , 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.

17. A method for occluding blood flow in a left atrial appendage in a heart of a patient, comprising:
advancing a balloon into a left atrial appendage, the balloon comprising a distal depression;
inflating at least a portion of the balloon via an inflation lumen from an outer catheter;
delivering adhesive to the distal depression of the balloon;
absorbing the adhesive with an adhesive-absorbing membrane positioned over distal depression of the balloon so that the adhesive is exposed on an outer surface of the adhesive-absorbing membrane; and,
detaching the outer catheter from the balloon.

18. The method of claim 17 , further comprising preventing inflation fluid from the balloon from entering into the distal depression of the balloon.

19. The occlusion system of claim 7 , wherein, in a delivery configuration, a distal portion of the inner catheter forms a spiral within the depression of the balloon.

20. The occlusion system of claim 11 , wherein the first valve and the second valve are interconnected together in linear alignment.

Assignees

• Terumo Corp

Inventors

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

Classifications

• A61B2017/12095

  Threaded connection · CPC title

• A61B2017/00632

  Occluding a cavity, i.e. closing a blind opening · CPC title

• A61B2017/00951

  adhesive · CPC title

• A61B17/12122

  within the heart (for closing a cardiac septal defect A61B17/0057) · CPC title

• A61B2017/00893

  pharmaceutically effective · CPC title