Variable structure element for implant devices, corresponding implant device and method of manufacturing

• US 20040098076A1
• Filed: 11/18/2002
• Published: 05/20/2004
• Est. Priority Date: 05/18/2001
• Status: Abandoned Application

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Bottelli, Andrea, Curcio, Maria, Rolando, Giovanni
• Application Number:
  US10/299,034
• Publication Number:
  US 20040098076A1
• Time in Patent Office: Days
• US Class Current: 623/1.1
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids

Abstract

In order to bestow on implantation devices, such as vascular prostheses, a certain degree of mechanical consistency and/or properties of tightness, operating in a non-traumatic way, there is envisaged the use of an element with modifiable structure. This is an element comprising a hydrophilic body that is able to absorb a mass of liquid so as to assume, as a result of the absorption of said mass of liquid, a certain degree of mechanical consistency. Preferably, the aforesaid element with modifiable structure has a base of mixtures of polymers such as polyvinyl alcohol and gellan, so as to give rise to hydrogels or else films that, in turn, give rise to hydrogels by hydration.

Claims

1. An element with modifiable structure for association to an implantation device, wherein the element is made up of a body that is able to absorb a mass of liquid so as to assume, as a result of the absorption of said mass of liquid, a certain degree of mechanical consistency.

2. The element according to claim 1, wherein said body has an apertured structure.

3. The element according to claim 2, wherein said apertured structure is in the form of a three-dimensional lattice.

4. The element according to claim 1, wherein said body is configured essentially as a cavernous body.

5. The element according to claim 1, wherein, during absorption of said mass of liquid, said body maintains a substantially constant volume.

6. The element according to claim 1, wherein said body is polymer-based, with a polymer chosen from among biostable polymers, biodegradable polymers and bioabsorbable polymers.

7. The element according to claim 1, wherein said body is synthetic polymer-based.

8. The element according to claim 1, wherein said body has a polyvinyl alcohol (PVA) base.

9. The element according to claim 1, wherein said body comprises mixtures of natural polymers.

10. The element according to claim 9, wherein said natural polymers are chosen from the group consisting of gellan, sodium alginate, hyaluronic acid, chitosan, dextran, and combinations thereof.

11. The element according to claim 1, wherein said body is based on a material with characteristics of thermosensitivity, so as to be able to modify its own consistency with variation of temperature.

12. The element according to claim 1, wherein said body is hydrogel-based.

13. The element according to claim 12, wherein said hydrogel is obtained starting from aqueous solutions subjected to freezing and thawing.

14. The element according to claim 1, wherein said body is based on a polymeric mixture.

15. The element according to claim 1, wherein added to said body are substances selected from the group consisting of:

(1) substances able to prevent phenomena of thrombogenesis;

(2) substances able to favour re-growth of tissue; and

(3) elasticizing substances.

16. The element according to claim 1, wherein said body is based on materials that are able to form hydrogels or films that can be transformed into hydrogels by hydration.

17. The element according to claim 1, wherein said body is based on hydrophilic polymer molecules crosslinked together.

18. The element according to claim 1, wherein said body is constituted starting from aqueous solutions of polymers mixed in amounts such as to obtain the pre-determined weight ratios and subsequent evaporation of the solvent.

19. The element according to claim 1, wherein, in said body, there is present in combination a polysaccharide.

20. The element according to claim 19, wherein said polysaccharide is chosen from among gellan, sodium alginate, and combinations thereof.

21. The element according to claim 19, wherein said body is based on polyvinyl alcohol and gellan.

22. The element according to claim 19, wherein in said body there is present an addition of glycerin.

23. The element according to claim 21, wherein the ratio between gellan and polyvinyl alcohol is between 5/95 and 20/80.

24. The element according to claim 23, wherein said ratio is substantially 20/80.

25. The element according to claim 1, wherein said body is based on a polymer that has undergone crosslinking.

26. The element according to claim 25, wherein said body comprises a polymer that has undergone crosslinking via chemical treatment.

27. The element according to claim 26, wherein said polymer is a polymer that has undergone crosslinking via the use of glutaric aldehyde (GTA).

28. The element according to claim 13, wherein the preparation of said hydrogels comprises repeated cycles of freezing and thawing.

29. An implantation device, wherein it has associated thereto an element with a modifiable structure of claim 1.

30. The implantation device according to claim 29, wherein said element is applied in the form of an annular structure.

31. The implantation device according to claim 29, wherein said element with a modifiable structure is provided according to a general helical path.

32. The implantation device according to claim 29, wherein the device comprises a prosthesis of an overall tubular shape having associated thereto said element with modifiable structure as element of consolidation and/or tightness.

33. The implantation device according to claim 32, wherein said element with modifiable structure has an overall annular shape and is associated to at least one of the ends of said tubular prosthesis.

34. The implantation device according to claim 29, wherein said element with modifiable structure comprises a reinforcement which extends over the development of the body of the implantation device.

35. The implantation device according to claim 29, wherein said element with modifiable structure is set, at least in part, on the outer surface of said implantation device.

36. The implantation device according to claim 35, wherein said element with modifiable structure forms, on the outer surface of the implantation device, a sealing formation between the implantation device and the treated lumen.

37. The implantation device according to claim 29, wherein it further comprises a supporting structure of the stent type.

38. A process for making an implantation device according to claim 29, wherein the body of said element with modifiable structure is applied on the implantation element by dipping.

39. The process for making an implantation device according to claim 29, wherein the body of said element with modifiable structure is applied on the implantation element by spreading.

40. The process according to claim 39, applied to an implantation device of a tubular shape, wherein the process comprises:

mounting the implantation device on a rotary spindle;

controlling rotation of said spindle and of the implantation device mounted thereon;

providing a source of supply of material which can constitute the body of said element with modifiable structure; and

approaching said source to said implantation device driven in rotation by said spindle, determining the application of said material on the implantation device according to a path of rotation.