Hydrophilic shape memory insertable medical articles

• US 20080039931A1
• Filed: 04/25/2007
• Published: 02/14/2008
• Est. Priority Date: 04/25/2006
• Status: Abandoned Application

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Jelle, Bruce, Chudzik, Stephen
• Application Number:
  US11/789,786
• Publication Number:
  US 20080039931A1
• Time in Patent Office: Days
• US Class Current: 623/1.18
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 27/14 Macromolecular materials
• 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 31/04 Macromolecular materials
• 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

Abstract

Insertable medical articles with a shape memory property having a body member formed of crosslinked hydrophilic polymers are described.

Claims

1. An insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer having a molecular weight of 100,000 Da or less, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration upon insertion of the article at a target site in a subject.

2. The insertable medical article of claim 1 wherein the hydrophilic polymer has a molecular weight of 50,000 Da or less.

3. The insertable medical article of claim 2 wherein the hydrophilic polymer has a molecular weight of 25,000 Da or less.

4. The insertable medical article of claim 3 wherein the hydrophilic polymer has a molecular weight in the range of 1000-10,000 Da.

5. The insertable medical article of claim 1 wherein the matrix comprises hydrophilic polymer that is crosslinked via polymerized groups.

6. The insertable medical article of claim 1 wherein the matrix comprises a hydrophilic polymer and a hydrophilic component crosslinked via first and second reacted groups, wherein the first and second reacted groups are pendent from the hydrophilic polymer and a hydrophilic component, respectively.

7. The insertable medical article of claim 6 wherein the first reactive group is present on the polysaccharide in an amount to provide a degree of substitution of 1.0 or less.

8. The insertable medical article of claim 7 wherein the first reactive group is present on the polysaccharide in an amount to provide a degree of substitution in the range of 0.2 to 0.3.

9. The insertable medical article of claim 6 wherein the first or second reacted group is an amine group.

10. The insertable medical article of claim 6 wherein the second component is non-biodegradable.

11. The insertable medical article of claim 6 wherein the second component has a MW of 10,000 Da or less.

12. The insertable medical article of claim 6 wherein the second component has a MW of 3,500 Da or less.

13. The insertable medical article of claim 6 wherein the hydrophilic component comprises an alkoxyalkane.

14. The insertable medical article of claim 8 wherein the alkoxyalkane is selected from the group consisting of tri(ethylene glycol), tetra(ethylene glycol), poly(ethylene oxide) (PEO), poly(ethylene glycol), and poly(propylene oxide) (PPO).

15. The insertable medical article of claim 6 wherein the hydrophilic component is a liquid at 25°

C.

16. The insertable medical article of claim 1 wherein the hydrophilic polymer is a natural biodegradable polymer.

17. The insertable medical article of claim 12 wherein the natural biodegradable polymer is selected from the group consisting of maltodextrin, amylose, polyalditol, and cyclodextrin.

18. The insertable medical article of claim 1 wherein the body member comprises 15% or greater by weight hydrophilic polymer.

19. The insertable medical article of claim 1 wherein the second configuration is linear.

20. The insertable medical article of claim 1 wherein the first configuration comprises a coil configuration.

21. The insertable medical article of claim 1 where the body member is in the form of a cylinder.

22. The insertable medical article of claim 1 comprising a body member for use in the vasculature.

23. The insertable medical article of claim 1 wherein the body member in the first configuration can exert pressure on tissue at the target site.

24. The insertable medical article of claim 23 comprising a stent.

25. The insertable medical article of claim 1 comprising a body member for use within the eye.

26. The insertable medical article of claim 1 comprising a bioactive agent.

27. The insertable medical article of claim 26 comprising a bioactive agent selected from the group consisting of polypeptides, polynucleotides, and polysaccharides.

28. The insertable medical article of claim 26 comprises a bioactive agent having a molecular weight of 10,000 or greater.

29. The insertable medical article of claim 1 wherein the body member is the second configuration has a second hydration state, and is capable of undergoing a shape memory transition to a first configuration upon insertion of the article at a target site in a subject which increases the hydration of the body member to a first hydration state.

30. The insertable medical article of claim 29 wherein in the second hydration state, the body member comprises an amount of water of 35% or less.

31. A method for preparing an insertable medical article comprising a body member having a shape memory property, the method comprising steps of:

providing a composition in a first configuration, the composition comprising;

a hydrophilic polymer having a molecular weight of 100,000 Da or less, and

a reactive group; and

causing reaction of the reactive group thereby forming a matrix of hydrophilic polymer and fabricating the body member in the first configuration,

wherein the body member is capable of reverting from a second configuration to the first configuration upon or following insertion at a target site in a subject.

32. The method of claim 31 where, in the step of providing, the composition comprises a hydrophilic polymer at a concentration of 250 mg/mL or greater.

33. The method of claim 31 where, in the step of providing, the composition comprises 50 wt % water or less.

34. The method of claim 33 comprising a step of removing at least a portion of water from the body member to stabilize the body member in the second configuration.

35. The method of claim 34 where, in the step of removing, at least 50% of the liquid present in the body member is removed.

36. The method of claim 34, wherein the step of providing a composition in a first configuration comprises a substep of mixing the hydrophilic polymer having a molecular weight of 100,000 Da or less comprising a first reactive group, and a second component that is hydrophilic and that comprises a second reactive group, wherein the first and second groups are specifically reactive and provide a crosslinked hydrophilic polymeric matrix upon mixing, thereby fabricating the body member in the first configuration.

37. The method of claim 36 wherein the hydrophilic polymer and second component react to form a first polymeric network and the composition further comprises a second hydrophilic polymer comprising a pendent polymerizable group, and the method further comprises a step of treating to cause polymerization of the second hydrophilic polymer which forms a second polymeric network that penetrates the first polymeric network, which forms the body member.

38. A method for treating a target site within a subject, comprising the steps of

obtaining an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration;

delivering the article to a target site in the body in the second configuration;

allowing the body member to revert from the second configuration to the first configuration at the target site,

wherein the body member in the first configuration exerts force on a tissue at the target site.

39. The method of claim 38, wherein the step of allowing the body member becomes hydrated to promote change to the first configuration.

40. A method for delivering a bioactive agent to a subject, comprising the steps of

obtaining an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer having a molecular weight of 100,000 Da or less and a bioactive agent, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration;

delivering the article to a target site in the body in the second configuration;

allowing the body member to revert from the second configuration to the first configuration at the target site; and

allowing release of the bioactive agent from the body member at the target site.

41. An insertable medical article comprising a body member formed of a hydrophilic matrix comprising a first polymeric network that penetrates a second polymeric network, wherein the body member is capable of undergoing a shape memory transition to the first configuration from a second configuration.

42. A system for delivering to a portion of a body an insertable medical article comprising a body member having a shape memory property comprising (a) an insertable medical article comprising a body member comprising a crosslinked matrix of hydrophilic polymer, wherein the body member is capable of undergoing a shape memory transition from a second configuration to a first configuration upon insertion of the article at a target site in a subject and (b) an insertion instrument capable of holding the article in the second configuration for delivery of the article to a portion of the body.