Occlusion device for closing anatomical defects

Patent metadata

Field	Value
Publication number	US-10905405-B2
Application number	US-201013516065-A
Country	US
Kind code	B2
Filing date	Dec 17, 2010
Priority date	Dec 17, 2009
Publication date	Feb 2, 2021
Grant date	Feb 2, 2021

Abstract

The present invention generally relates to the field of transcatheter device closure techniques for closing an opening in a tissue and more particularly, to occlusion devices for closing anatomical defects in tissue such as defects consisting of an opening connecting a front side and a back side of a tissue. More particularly the present invention relates to occlusion devices for closing septal abnormalities such as atrial septal defects and patent foramen ovale, delivering systems for such occlusion devices, kits comprising the occlusion devices and the delivering systems and to methods of closing an anatomical defect in a tissue consisting of an opening connecting a front side and a back side of a tissue.

First claim

The invention claimed is:

1. An occlusion device for closing an anatomical defect in tissue comprising an opening connecting a front side and a back side of a tissue, wherein the occlusion device is adapted to be included into a sheath of a catheter, and the occlusion device comprises:
(i) a scaffold comprising:
a head tube positioned at an anterior end of the scaffold,
a tail tube positioned at a posterior end of the scaffold; wherein the head tube and the tail tube are movable along the direction towards and away from each other, and
an engaging means connected to the head tube and being adapted to be engagable at the tail tube, and

(ii) a foldable section comprising:
a foldable head portion which is connected at one end to the head tube and being adapted to be disposed together with the head tube at the front side of the anatomical defect,
a foldable tail portion which is connected to one end of the tail tube and being adapted to be disposed together with the tail tube at the back side of the anatomical defect, and
a waist portion adapted to extend through the opening of the anatomical defect and being arranged between the foldable head portion and the foldable tail portion,

wherein each of the foldable head portion and the foldable tail portion comprises two arms extending between the head tube and the waist portion and between the tail tube and the waist portion, respectively, wherein each arm consist of at least one sheet-like film having a folding segment at which the arm is foldable such that a part of the arm extending from one side of the folding segment folds over another part of the arm extending from another side of the folding segment,
wherein the two arms of at least one of the foldable head portion and the foldable tail portion are configured such that, in the folded state when deployed for closing the anatomical defect, surfaces of the two arms facing the tissue extend completely around the anatomical defect, and
wherein the folding segment of each arm defines a folding axis and is pre-configured with greater flexibility at the folding axis than said part and said another part of the arm so as to facilitate folding of the arm about the folding axis.

2. The occlusion device according to claim 1 , wherein the two arms of the foldable head portion are arranged on each other in a manner that the engaging means is positioned between the two arms.

3. The occlusion device according to claim 1 , wherein the two arms of the foldable tail portion are arranged on each other in a manner that the engaging means is positioned between the two arms.

4. The occlusion device according to claim 1 , wherein the engaging means is a hollow tube.

5. The occlusion device according to claim 1 , wherein the engaging means is integrally provided with the head tube and wherein the engaging means extends from the head tube in the direction of the tail tube and wherein, in an unfolded form of the occlusion device, the engaging means extends over a length in the direction of the tail tube which is half the length between the waist portion and the head tube.

6. The occlusion device according to claim 1 , wherein the head tube is hollow and has a threaded interior.

7. The occlusion device according to claim 6 , wherein the engaging means is engageable at the tail tube by means of a lock which is a flexible end cap having two crossed slots in its center wherein the end cap is integrally provided at the posterior end of the tail tube.

8. The occlusion device according to claim 1 , wherein the foldable head portion is welded to the head tube and/or the foldable tail portion is welded to the tail tube.

9. The occlusion device according to claim 1 , wherein the foldable head portion is laminated with the head tube and/or the foldable tail portion is laminated with the tail tube.

10. The occlusion device according to claim 1 , wherein the foldable head portion is glued on the head tube and/or the foldable tail portion is glued on the tail tube.

11. The occlusion device according to claim 1 , wherein the foldable head portion is sewed to the head tube and/or the foldable tail portion is sewed to the tail tube.

12. The occlusion device according to claim 1 , wherein at least one of or all of the head tube, the end tube, the engaging means, or the foldable section are of a polymeric material.

13. The occlusion device according to claim 12 , wherein the polymeric material comprises a non-biodegradable or a biodegradable polymer.

14. The occlusion device according to claim 13 , wherein the non- biodegradable polymer is selected from the group consisting of polyurethane, poly(ether urethanes), poly(ester urethanes), polyvinylchloride, polyalkylenes, polyethylene terephtalate polyvinylacetate, poly ethylene-co-vinyl acetate and nylon.

15. The occlusion device according to claim 13 , wherein the biodegradable polymer is selected from the group consisting of polycaprolactone (PCL), polylactic acid (PLA), polycaprolactone-polylactic acid copolymer (PCL-PLA copolymer), polyglycolide (PLGA), poly-L-lactide (PLLA), poly-D-lactide (PDLA), polygluconate (PGA), polylactide-polygluconate copolymer (PLGA), polylactic acid-polyethylene oxide copolymers, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(amino acids), polydioxanone, cellulose, collagen and chitosan.

16. The occlusion device according to claim 12 , wherein the polymeric material of the foldable section has a modulus range of about 104 to about 107 Pa at 37° C.

17. The occlusion device according to claim 1 , wherein the entire occlusion device is made of a polymeric material.

18. The occlusion device according to claim 1 , wherein the tail tube has a threaded exterior surface.

19. The occlusion device according to claim 1 , wherein one or more elements selected from the head tube, the tail tube, the engaging member and the foldable section comprise a therapeutically active agent.

20. The occlusion device according to claim 19 , wherein the therapeutically active agent is selected from the group consisting of a drug, an antibiotic, an anti-inflammatory agent, an anti-clotting factor, a hormone, a nucleic acid, a peptide, a cellular factor, a growth factor, a ligand for a cell surface receptor, an anti-proliferation agent, an anti-thrombotic agent, an antimicrobial agent, an anti-viral agent, a chemotherapeutic agent, and an anti-hyertensive agent.

21. The occlusion device according to claim 1 , wherein one or more elements selected from the group of the head tube, the tail tube, the engaging means and the foldable section comprise a radiopacifier deposited at its surface and/or blended in the material the elements comprise.

22. A delivering system for an occlusion device of claim 1 adapted to be included into a sheath of a catheter, comprising:
at least one first delivering means adapted to push the occlusion device through a sheath and to guide the head portion of the foldable section in a position at the front side of a tissue defect, and
at least one second delivering means adapted to move the tail tube into the direction of the head tube to allow the tail tube to be moved against the back side of the tissue.

23. The delivering system according to claim 22 , wherein the at least one first delivering means is a delivering rod extending through the tail tube towards the head tube of the occlusion device and being removably connected to the head tube.

24. The delivering system according to claim 23 ,

Assignees

• Venkatraman Subramanian
• Boey Yin Chiang Freddy
• Wu Wei
• Tang Yong Dan
• Yip Wei Luen James
• Duong Hong Duc
• Univ Nanyang Tech

Inventors

• Venkatraman Subramanian
• Boey Yin Chiang Freddy
• Wu Wei
• Tang Yong-Dan
• Yip Wei Luen James
• Duong Hong Duc

Classifications

• A61B2017/00597

  Implements comprising a membrane · CPC title

• A61B2017/00606

  Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening · CPC title

• A61B2017/00592

  Elastic or resilient implements · CPC title

• A61B2017/00243

  cardiac · CPC title

• A61B2017/00623

  Introducing or retrieving devices therefor · CPC title