Bioabsorbable medical devices

Patent metadata

Field	Value
Publication number	US-11911272-B2
Application number	US-202016745831-A
Country	US
Kind code	B2
Filing date	Jan 17, 2020
Priority date	Jan 18, 2019
Publication date	Feb 27, 2024
Grant date	Feb 27, 2024

Abstract

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a plurality of absorbable filaments arranged in a support structure and configured degrade within a defined time period and a membrane arranged about the plurality of absorbable filaments and configured to contain fragments of the plurality of absorbable filaments in response to a fracture or degradation of a filament.

First claim

What is claimed is:

1. An apparatus comprising:
a support structure including a plurality of absorbable filaments configured to support a tissue and degrade within a defined time period; and
a membrane arranged about an entirety of the support structure including the plurality of absorbable filaments and an entirety of at least one of a proximal end and a distal end, the membrane configured to contain fragments of the plurality of absorbable filaments in response to a fracture or degradation of a filament, the membrane defining a first layer and a second layer, the plurality of absorbable filaments being arranged between layers of the membrane such that the first layer and the second layer of the membrane sandwich the plurality of absorbable filaments, wherein the proximal end is an integral portion of a proximal disk comprising a proximal expanded diameter portion such that the proximal end does not protrude beyond a proximal end of the proximal disk.

2. The apparatus of claim 1 , wherein the membrane is configured to promote tissue growth and remain with the tissue after degradation of the absorbable f ilam ents.

3. The apparatus of claim 1 , wherein the absorbable filaments are at least one of bio-absorbable and bio-corrodible.

4. The apparatus of claim 1 , further including a proximal hub arranged at a proximal end of the plurality of absorbable filaments, a distal hub arranged at a distal end of the plurality of absorbable filaments, the proximal disk configured to contact a first side of a tissue wall, and a distal disk configured to contact a second side of a tissue wall.

5. The apparatus of claim 4 , further including an elastic tensile member arranged coupled to the proximal hub and the distal hub and within the support structure, the elastic tensile member being configured to bring the proximal disk into apposition with the first side of the tissue wall and the distal disk into apposition with the second side of the tissue wall.

6. The apparatus of claim 4 , further including a catch member arranged to, when engaged, connect the proximal hub and the distal hub within the support structure, the catch member being configured to bring the proximal disk into apposition with the first side of the tissue wall and the distal disk into apposition with the second side of the tissue wall.

7. The apparatus of claim 4 , wherein the proximal hub includes proximal end portions of the plurality of absorbable filaments and the distal hub includes distal end portions of the plurality of absorbable filaments.

8. The apparatus of claim 7 , wherein the proximal end portions of the plurality of absorbable filaments are formed together to form the proximal hub and the distal end portions of the plurality of absorbable filaments are formed together to define the distal hub.

9. The apparatus of claim 4 , further comprising an intermediate hub including central portions of the plurality of absorbable filaments.

10. The apparatus of claim 9 , wherein the intermediate hub includes a band of material arranged about the central portions of the plurality of absorbable filaments.

11. The apparatus of claim 4 , wherein central portions of the plurality of absorbable filaments define a waist configured to form an open central area within the plurality of absorbable filaments.

12. The apparatus of claim 11 , wherein the waist is configured to bring the proximal disk into apposition with the first side of the tissue wall and the distal disk into apposition with the second side of the tissue wall.

13. The apparatus of claim 1 , wherein the membrane is configured to allow contact between the plurality of absorbable filaments and blood or moisture to facilitate degradation of the plurality of absorbable filaments.

14. The apparatus of claim 1 , wherein the membrane includes a gap configured to allow direct tissue contact with the absorbable filaments.

15. The apparatus of claim 1 , wherein the membrane is configured to facilitate movement of the plurality of absorbable filaments.

16. The apparatus of claim 1 , wherein the plurality of absorbable filaments and the membrane are configured to facilitate crossing of an atrial septum after implantation.

17. The apparatus of claim 1 , wherein at least one of the plurality of absorbable filaments includes a cross-section that is at least one of uneven, jagged, star-like, or polygonal.

18. The apparatus of claim 1 , wherein the membrane is porous.

19. The apparatus of claim 18 , wherein the plurality of filaments produce a degradation product as the plurality of filaments degrade, and wherein the membrane includes pores operable to allow the degradation product to pass through the pores once dimensions of the degradation product are reduced to a dimension at least as small as a dimension of the pores.

20. The apparatus of claim 1 , wherein the support structure is tubular and is sandwiched between the first and second layers of the membrane so as to contain the plurality of filaments and/or fragments of the plurality of filaments therebetween.

21. The apparatus of claim 1 , wherein the support structure is tubular having an inside and an outside, wherein a layer of membrane is adjacent the inside and the second layer of membrane is adjacent the outside so as to contain the plurality of filaments and/or fragments of the plurality of filaments therebetween.

22. The apparatus of claim 1 , wherein the support structure is tubular and the filaments are sandwiched between the first and second layers of the membrane so as to contain the plurality of filaments and/or fragments of the plurality of filaments between the first and second layers of the membrane.

23. The apparatus of claim 1 , wherein the membrane is configured to promote at least one of tissue ingrowth into the membrane and tissue encapsulation of at least a portion of the membrane.

24. A medical implantable occlusion device comprising:
a braiding of at least one absorbable filament said braiding having a deployed state and an elongated state and a proximal and distal end and the braiding comprising a proximal end hub, a proximal expanded diameter portion, a center portion, a distal expanded diameter portion, and a distal hub extending along a longitudinal axis in the deployed state and configured to be stretched into a tubular formation in the elongated state, the filament being helically wound and interwoven in multiple directions to allow for natural expansion, wherein the proximal end hub is an integral portion of the proximal expanded diameter portion such that the proximal end hub does not protrude beyond the proximal end of the medical implantable occlusion device; and
a membrane arranged about an entirety of the braiding and configured to contain fragments of the braid, the membrane defining a first layer and a second layer, the braiding arranged between the first layer and the second layer.

25. A method of treating an opening in a patient, the method comprising:
delivering a medical device within an opening at a treatment site, the medical device having a scaffold including a plurality of absorbable filaments arranged in a support structure having a first hub and a second hub with a waist extending therebetween, the scaffold configured to support a tissue and degrade within a defined time period and a membrane arranged about an entirety of the support structure including the plurality of absorbable filaments and an entirety of at least one of a proximal

Assignees

• Gore & Ass

Inventors

• Chan Michael C
• Cully Edward H
• Duncan Jeffrey B
• Hayes Byron K
• Joynson Samuel
• Mcdaniel Tom R
• Messick David J
• Shaw Edward E

Classifications

• A61F2/2439 Primary

  Expansion controlled by filaments · 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

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61L27/58

  Materials at least partially resorbable by the body · CPC title

• A61B2017/00575

  for closure at remote site, e.g. closing atrial septum defects · CPC title