Means for Controlled Sealing of Endovascular Devices

• US 20130331929A1
• Filed: 03/15/2013
• Published: 12/12/2013
• Est. Priority Date: 09/09/2011
• Status: Abandoned Application

• Current Assignee: Endoluminal Sciences Pty Ltd
• Original Assignee: Endoluminal Sciences Pty Ltd
• Inventors: Mitra, Ashish Sudhir, Bobillier, Ben Colin, Wong, Pak Man Victor
• Application Number:
  US13/844,535
• Publication Number:
  US 20130331929A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/0036 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 33/04 Homopolymers or copolymers of esters C08L43/04 takes precedence
• CPC Class Codes: C08L 33/08 Homopolymers or copolymers of acrylic acid esters
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

Expandable sealing means for endoluminal devices have been developed for controlled activation. The devices have the benefits of a low profile mechanism (for both self-expanding and balloon-expanding prostheses), contained, not open, release of the material, active conformation to the “leak sites” such that leakage areas are filled without disrupting the physical and functional integrity of the prosthesis, and on-demand, controlled activation, that may not be pressure activated.

Claims

1. An endoluminal seal for sealing an endoluminal implant or prosthesis to a wall of a lumen of a subject, the endoluminal seal comprising:

An expandable material selected from the group consisting of hydrogels, sponges and foams optionally spray dried or chemically coupled to the interior of the endoluminal seal,

A first membrane adjacent to and containing the expandable material;

Wherein the expandable material is activated by exposure to a fluid or a foaming agent.

2. The endoluminal seal of claim 1 wherein

the expandable material is a hydrogel which expands two to one hundred fold, preferably 50 to 90 fold, upon contact with a fluid, and

the first membrane is permeable to fluid.

3. The endoluminal seal of claim 2 comprising a swellable hydrogel material selected from the group consisting of polyacrylic acids and polyalkylene oxides.

4. A hydrogel for use in an endoluminal seal, wherein the hydrogel is able to expand rapidly upon hydration to at least ten times the volume of the dry state, more preferably up to 50×

the volume of the dry state.

5. The hydrogel of claim 4 wherein the swelling force exerts a radial force between 0.001N/mm² and 0.025N/mm²′

, more preferably between 0.008N/mm² and 0.012N/mm².

6. The hydrogel of claim 4 wherein the hydrogel expands from 2-100 times, preferably 50-90 times, most preferably about 60 times the volume of the dry state within 10 minutes, preferably less than 3 minutes, following contact with aqueous fluid.

7. The hydrogel of claim 4, wherein the hydrogel does not change volume at both room temperature and 37-40°

C.

8. The hydrogel of claim 4, wherein the hydrogel comprises a long chain cross-linker having more than 20 carbons and/or a molecular weight greater than 400 Da, more preferably more than 40 carbon atoms and/or a molecular weight greater than 800 Da

9. The hydrogel of claim 8, wherein the long chain crosslinker is selected from the group consisting of polyvinyl alcohol, polyethylene glycol, polyvinyl acetate, dextrans, hyaluronic acids, agaroses, collagen, and starch.

10. The hydrogel of claim 8, wherein the crosslinker has multiple polymerizable groups.

11. The hydrogel of claim 10, wherein the multiple polymerizable groups are vinyl groups.

12. The hydrogel of claim 4, wherein the polymer is selected from the group consisting of acrylic acid, acrylamide or other polymerizable monomers;

cross-linkers such as polyvinyl alcohols and partially hydrolyzed poly vinyl acetates, 2-hydroxyethyl methacrylates or other polymers with reactive side groups such as acrylic, allylic, and vinyl groups.

13. A fluid isolatable expandable seal for a vascular device comprising

A hydrogel strip,

A polymeric film encapsulating the hydrogel strip,

The encapsulated strip being positioned on the exterior circumference of the vascular device, wherein the exterior of the encapsulated strip expands upon contact with a fluid, and

The film has a slit that opens to allow fluid to hydrate the hydrogel strip.

14. The seal of claim 13 comprising a porous mesh between the hydrogel strip and the film.

15. The seal of claim 13 made by blow molding.

16. A fluid isolatable expandable seal for a vascular device comprising

A polymeric film expanding to form a seal which is positioned on the exterior circumference of the vascular device, wherein the exterior of the encapsulated strip expands upon contact with a fluid, and

The film has an opening that is open to allow fluid to fill the expandable film, which self-seals by positive displacement when the expandable film is fully hydrated.

17. The seal of claim 16 further comprising a hydrogel strip within the expandable film, which hydrates and expands when the film fills with fluid.

18. The seal of claim 16 further comprising a one-way valve which closes the expandable film when fully expanded.

19. A fluid isolatable expandable seal for a vascular device comprising

A polymeric film blow molded to form a “

D”

balloon over a porous mesh, which is heat or laser welded to seal a hydrogel strip between the film and the mesh.

20. The seal of claim 19 attached to the exterior circumference of a vascular device.

21. The seal of claim 19 having a cross sectional profile in the shape of the letter “

D”

, with the flat portion lying in abutment to the vascular device. prosthesis while the curved portion of the D profile faces outward.

22. The seal of claim 19 further comprising one or more engagement members.

23. A stent-balloon-vascular device with seal comprising

A stent containing a vascular device and balloon for centering of the device as it is positioned,

a seal on the inside of the stent containing the vascular device,

wherein the seal is positioned in abutment with the device, so that the seal is flipped out and over the end edge of the vascular device as the device is expanded and immediately prior to positioning, wherein the device is centered by the balloon.

24. The device of claim 23 comprising straps to flip the seal out and over the end edge of the device.

25. A removable casing formed of a metal or polymer for fluidic isolation of an expandable seal on the exterior of a vascular device,

the casing having as in a “

U”

shape that allows for complete insertion of the seal within the “

U”

cavity when attached to the exterior circumference of the vascular device,

wherein the open end of the “

U”

cavity has O-rings and a locking mechanism that fit together to compress the O-rings to bring them under pressure, thereby allowing the formation of a fluid-tight seal.

26. An endoluminal seal for sealing an expandable endoluminal implant or prosthesis to a wall of a lumen of a subject, the endoluminal seal comprising:

an expandable film containing a foaming material activatable by exposure to a fluid or a foaming agent, secured to the exterior circumference of a vascular device, the vascular device having on the interior circumference spring struts which push through the vascular implant or prosthesis to force the foam within the expandable material outward from the vascular device.

27. An endoluminal seal for sealing an expandable vascular device, the endoluminal seal comprising:

a polymeric fluid impermeable membrane removable casing formed of a metal or polymer for fluidic isolation of an expandable seal on the exterior of a vascular device,

an expandable material selected from the group consisting of hydrogels, sponges and foams optionally spray dried or chemically coupled to the interior of the endoluminal seal,

a first membrane adjacent to and containing the expandable material;

wherein the expandable material is activated by exposure to a fluid or a foaming agent, and

a fluid impermeable membrane fluidically isolating the expandable material until exposed to an aqueous solution under physiological conditions.

28. The seal of claim 27 wherein the fluid impermeable membrane remains intact in glutaraldehyde.

29. The seal of claim 27 wherein the membrane is made of polyvinyl alcohol or polyacrylamide which dissolves at physiological pH, in isotonic fluid, or in a specific liquid.

30. A plug for preventing exposure of an endoluminal seal for sealing an expandable vascular device including tissue which must be stored hydrated,

the endoluminal seal comprising an expandable material selected from the group consisting of hydrogels, sponges and foams optionally spray dried or chemically coupled to the interior of the endoluminal seal, wherein the expandable material is activated by exposure to a fluid or a foaming agent,

the compliant plug being shaped to be inserted into the vascular device to prevent fluid from passing beyond the tissue to reach the seal.

31. The plug of claim 30 formed of silicone or rubber.

32. The plug of claim 30 in a vascular device, further comprising mechanical means for compressing the exterior of the device against the inner plug.

33. The plug of claim 32 wherein the means of applying a mechanical pressure is a ratchet mechanism belt or other oversized compliant material belts.

34. A metal film or metal-polymer laminate for preventing exposure of an endoluminal seal for sealing an expandable vascular device including tissue which must be stored hydrated,

the endoluminal seal comprising an expandable material selected from the group consisting of hydrogels, sponges and foams optionally spray dried or chemically coupled to the interior of the endoluminal seal, wherein the expandable material is activated by exposure to a fluid or a foaming agent,

the laminate comprising a metallic film or a metallic film with a polymer laminate that acts as a barrier during the storage of the vascular device in fluid and is removable by peeling off the metal film or laminate along a pre-scored tear line.

35. The metal film or metal-polymer laminate of claim 34 further comprising full tabs to remove the metal film or barrier.

36. A packaging case for an endoluminal seal for sealing an expandable vascular device including tissue which must be stored hydrated,

the endoluminal seal comprising an expandable material selected from the group consisting of hydrogels, sponges and foams optionally spray dried or chemically coupled to the interior of the endoluminal seal, wherein the expandable material is activated by exposure to a fluid or a foaming agent,

the container having an upper and a lower compartment, which are not in fluid communication.

37. The packaging case of claim 36 comprising o-rings that fluidically separate the upper and lower compartments.

38. The packaging case of claim 36 further comprising a core that seals the upper tissue containing portion of the vascular device from the lower portion including the expandable seal.

39. The packaging case of claim 36 further comprising a polymeric material that is placed into the bottom compartment after insertion of the vascular device that creates a fluid seal between the upper tissue containing portion of the vascular device and the lower portion including the expandable seal.

40. A fluid absorbant material for placement within a vascular device to keep only the tissue portion hydrated.