Occlusion device for closing anatomical defects

Patent metadata

Field	Value
Publication number	US-11154284-B2
Application number	US-201214233132-A
Country	US
Kind code	B2
Filing date	Jul 16, 2012
Priority date	Jul 15, 2011
Publication date	Oct 26, 2021
Grant date	Oct 26, 2021

Abstract

An occlusion device for closing an anatomical defect in tissue comprising a conduit connecting an opening on a first tissue and an opening on a second tissue is provided. The occlusion device comprises a scaffold comprising a) a proximal support structure comprising at least two arms; b) a distal support structure comprising at least two arms, wherein the arms are adapted to provide anchorage for the device in the tissue; and c) a waist portion adapted for extending through the opening on the first tissue and connecting the proximal support structure with the distal support structure, wherein the scaffold consists essentially of a biodegradable polymer, wherein the proximal support structure and the distal support structure comprise or consist of polycaprolactone (PCL), poly-(D,L-lactide-co-caprolactone) (PLC), or a mixture thereof. A method of closing an anatomical defect using the occlusion device is also provided.

First claim

The invention claimed is:

1. An occlusion device for closing an anatomical defect in tissue that includes a conduit connecting an opening on a first tissue and an opening on a second tissue, the occlusion device comprising:
a scaffold that includes:
a proximal support structure comprising at least two arms;
a distal support structure comprising a threaded interior surface and at least two arms, wherein a tip of a free end of each of the respective arms of the distal support structure is adapted to contact a conduit wall of the conduit to provide anchorage for the distal support structure within the conduit; and
a waist portion configured to extend through the opening on the first tissue and connect the proximal support structure with the distal support structure, and

a delivering system that includes:
a sheath;
a rod comprising a threaded exterior surface; and
a reinforced rod housing surrounding the rod and extending longitudinally along the rod,

wherein the threaded exterior surface of the rod is engaged with the threaded interior surface of the distal support structure for moving the scaffold through the sheath,
wherein, when the entire scaffold is in the sheath, the rod is engaged to the distal support structure with a longitudinal end of the reinforced rod housing directly abutting the distal support structure as the rod moves the scaffold through the sheath,
wherein, when in the sheath, the at least two arms of the proximal support structure are folded at respective inner ends in an outward direction away from the waist portion, and the at least two arms of the distal support structure are folded at respective inner ends in an inward direction in the direction of the waist portion, and
wherein the scaffold consists essentially of at least one biodegradable polymer, wherein the proximal support structure and the distal support structure comprise polycaprolactone (PCL), poly-(D,L-lactide-co-caprolactone) (PLC), or a mixture thereof.

2. The occlusion device according to claim 1 , wherein the scaffold further comprises a proximal occlusion film supported by the proximal support structure.

3. The occlusion device according to claim 1 , wherein the at least two arms of the proximal support structure are three or more spokes outwardly extending from a middle of the proximal support structure and having the respective inner ends connected with each other.

4. The occlusion device according to claim 1 , wherein the at least two arms of the distal support structure are three or more spokes outwardly extending from a middle of the distal support structure and having the respective inner ends connected with each other.

5. The occlusion device according to claim 1 , wherein:
the at least two arms of the proximal support structure include 2 to 8 spokes outwardly extending from a middle of the proximal support structure and having the respective inner ends connected with each other; and
the at least two arms of the distal support structure include 2 to 8 spokes outwardly extending from a middle of the distal support structure and having the respective inner ends connected with each other.

6. The occlusion device according to claim 1 , wherein the distal support structure includes a middle and the at least two arms of the distal support structure are adapted to provide anchorage for the device in the tissue by outwardly extending from the middle of the distal support structure and contacting a wall of the conduit.

7. The occlusion device according to claim 1 , wherein the scaffold includes a proximal occlusion film that is supported by the proximal support structure and expands between the at least two arms of the proximal support structure.

8. The occlusion device according to claim 1 , wherein the proximal support structure, the distal support structure and the waist portion are integrally formed.

9. The occlusion device according to claim 1 , wherein the biodegradable polymer is selected from the group consisting of polycaprolactone (PCL), poly-(D,L-lactide-co-caprolactone) (PLC), poly-L-lactide (PLLA), poly-D-lactide (PDLA), polyglycolide (PGA), polylactic acid (PLA), polycaprolactone-polylactic acid copolymer (PCL-PLA copolymer), polylactide-polyglycolide copolymer (PLGA), poly(trimethylene carbonate) (TMC); copolymers of polycaprolactone (PCL) and poly(trimethylene carbonate) (TMC); triblock copolymers of polylactic acid (PLA), polycaprolactone (PCL) and/or poly(trimethylene carbonate) (TMC); polylactic acid-polyethylene oxide copolymers, polygluconate polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(amino acids), polydioxanone, cellulose, collagen, chitosan, and mixtures thereof.

10. The occlusion device according to claim 9 , wherein the scaffold further comprises a proximal occlusion film supported by the proximal support structure and wherein one or more elements selected from the group of the proximal support structure, the proximal occlusion film, the distal support structure, and the waist portion comprise a radiopacifier.

11. The occlusion device according to claim 10 , wherein the proximal support structure and the distal support structure comprise respective radiopacifiers.

12. The occlusion device according to claim 10 , wherein the radiopacifier comprises barium sulfate.

13. The occlusion device according to claim 10 , wherein the amount of radiopacifier comprised in either of, or both, the proximal occlusion film and waist portion ranges from about 0 wt % to about 40 wt %.

14. The occlusion device according to claim 10 , wherein the amount of radiopacifier comprised in either of, or both, the proximal support structure and the distal support structure ranges from about 1 wt % to about 40 wt %.

15. The occlusion device according to claim 1 , wherein the waist portion consists essentially of a biodegradable polymer selected from the group consisting of polycaprolactone (PCL), poly-(D,L-lactide-co-caprolactone) (PLC), poly-L-lactide (PLLA), poly-D-lactide (PDLA), polyglycolide (PGA), polylactic acid (PLA), polycaprolactone-polylactic acid copolymer (PCL-PLA copolymer), polylactide-polyglycolide copolymer (PLGA), poly(trimethylene carbonate) (TMC); copolymers of polycaprolactone (PCL) and poly(trimethylene carbonate) (TMC); triblock copolymers of polylactic acid (PLA), polycaprolactone (PCL) and/or poly(trimethylene carbonate) (TMC), and mixtures thereof.

16. The occlusion device according to claim 1 , wherein the proximal support structure is more flexible than the remainder of the scaffold.

17. The occlusion device according to claim 1 , wherein the proximal support structure has shape memory.

18. The occlusion device according to claim 17 , wherein the proximal support structure elastically deforms in response to an applied force, and returns to more than 50% of its original shape upon release of the applied force.

19. The occlusion device according to claim 1 , wherein the scaffold further comprises a proximal occlusion film supported by the proximal support structure and wherein one or more elements selected from the proximal support structure, the proximal occlusion film, the distal support structure, and the waist portion comprise a therapeutically active agent.

20. The occlusion device according to claim 19 , wherein the therapeutically active agent is present as a coating on the proximal occlusion film.

21. 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-inflam

Assignees

• Venkatraman Subramanian
• Boey Yin Chiang Freddy
• Khanolkar Laximikant
• Rao Prasada
• Univ Nanyang Tech

Inventors

• Venkatraman Subramanian
• Boey Yin Chiang Freddy
• Khanolkar Laximikant
• Rao Prasada

Classifications

• A61B2017/00597

  Implements comprising a membrane · CPC title

• A61B2017/00615

  Implements with an occluder on one side of the opening and holding means therefor on the other · CPC title

• A61B2017/00004

  (bio)absorbable, (bio)resorbable or resorptive · CPC title

• A61L31/16

  Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} · CPC title

• A61B17/0057 Primary

  Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009) · CPC title