Coated Balloons for Blood Vessel Stabilization

• US 20120323211A1
• Filed: 05/17/2012
• Published: 12/20/2012
• Est. Priority Date: 05/18/2011
• Status: Active Grant

• Current Assignee: Nectero Medical, Inc.
• Original Assignee: Nectero Medical, Inc.
• Inventors: Ogle, Matthew F., Carlyle, Wenda C., Anderson, Edward J., Udipi, Kishore
• Granted Patent: US 9,937,255 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/11 Aldehydes
• CPC Class Codes: A61K 31/7024 Esters of saccharides
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

A coated balloon device for stabilizing a section of a blood vessel in a living subject is disclosed. The coating layer of the coated balloon comprises a phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with peripheral phenolic hydroxyl groups. The coating layer of the coated balloon may contain a hydrophilic polymer to facilitate the release of the phenolic compound. The balloon in general is made of a compliant polymer for atraumatic contact with the blood vessel. In some embodiments, the coating of the coated balloon device further comprises a hydrophilic undercoat layer between the balloon and the coating layer. In some embodiments, the coated balloon device further comprises a sacrificial top coating that dissolves upon delivery into the section of the blood vessel and comprises a hydrophilic composition including sugar, sugar derivatives, or a combination thereof.

Claims

1. A coated balloon device for stabilizing a section of a blood vessel in a living subject comprising,

a shaft having a proximal end and a distal end,

a balloon element comprising an extendable structure having an outer surface, the balloon element being supported by the shaft at or near the distal end of the shaft, and

a coating layer associated with the outer surface of the extendable structure,

wherein at least 5% by weight of the coating layer comprises a therapeutic composition that comprises a phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with peripheral phenolic hydroxyl groups, and

wherein the extendable structure of the balloon element comprises an unextended configuration, an inflated but un-expanded configuration and an expanded configuration.

2. The coated balloon device of claim 1 wherein the therapeutic composition has little or no unbound gallic acid.

3. The coated balloon device of claim 1 wherein the phenolic compound is tannic acid or an analog of tannic acid, pentagalloylglucose or an analog of pentagalloylglucose, a combination thereof, or a pharmaceutically acceptable salt thereof.

4. The coated balloon device of claim 1 wherein the phenolic compound is a flavonoid or a flavonoid derivative, a flavolignan or a flavolignan derivative, a phenolic rhizome or a phenolic rhizome derivative, a flavan-3-ol or a flavan-3-ol derivative, a tannin or a tannin derivative, an ellagic acid or an ellagic acid derivative, a procyanidin or a procyanidin derivative, proanthocyanidin, anthocyanins, quercetin, (+)-catechin, (−

)-epicatechin, nobotanin, epigallocatechin gallate, gallotannins, hydroxytyrosol (3,4-dihydroxy phenylethanol), oleuropein, prodelphinidin, a combination thereof, or a pharmaceutically acceptable salt thereof.

5. The coated balloon device of claim 1 wherein at least 50% by weight of the coating layer comprises the phenolic compound.

6. The coated balloon device of claim 1 wherein the coating layer have a thickness from about 20 microns to about 50 microns.

7. The coated balloon device of claim 1 wherein the therapeutic composition further comprises glutaraldehyde.

8. The coated balloon device of claim 1 wherein the coating layer further comprises a hydrophilic polymer.

9. The coated balloon device of claim 8 wherein the hydrophilic polymer comprises polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, poly(lactic-co-glycolic acid), or a combination thereof.

10. The coated balloon device of claim 8 wherein the hydrophilic polymer comprises polysaccharide, dextran, starch, hyaluronic acid, collagen, gelatin, chitin, albumin, alginate, as such or as a derivative or a combination thereof.

11. The coated balloon device of claim 1 wherein the extendable structure of the balloon element comprises a compliant polymer and the inflated but unexpanded configuration has a generally cylindrical section along the outer surface.

12. The coated balloon device of claim 1 wherein the extendable structure of the balloon element is a low durometer polyurethane balloon material.

13. The coated balloon device of claim 1 wherein the shaft comprises a balloon lumen having a distal opening into the interior of the balloon element and a proximal connection connected to a fluid source.

14. The coated balloon device of claim 1 further comprising a by-pass channel with an opening proximal to the balloon element and an opening distal to the balloon element that provides flow past the balloon when expanded in a vessel.

15. The coated balloon device of claim 1 wherein the coating further comprises a hydrophilic undercoat layer between the balloon element and the coating layer.

16. The coated balloon device of claim 15 wherein the undercoat layer has a thickness of from about 5 micron to about 50 microns.

17. The coated balloon device of claim 15 wherein the thickness ratio between the coating layer and the undercoat layer is from about 1:

1 to about 10;

1.

18. The coated balloon device of claim 15 wherein the undercoat layer is crosslinked to the balloon element.

19. The coated balloon device of claim 15 wherein the undercoat layer is porous to allow further hydration of the coating layer.

20. The coated balloon device of claim 1 further comprising a sheath slidably positioned over the shaft having a configuration extended in a distal direction relative to the shaft covering the extendable structure in the unextended configuration.

21. The coated balloon device of claim 1 further comprising a sacrificial top coating that dissolves upon delivery into the section of the blood vessel and comprises a hydrophilic composition.

22. The coated balloon device of claim 21 wherein the hydrophilic composition of the top coating is sugar, sugar derivatives, or a combination thereof.

23. The coated balloon device of claim 21 wherein the top coating has a thickness of from about 5 micron to about 50 microns.

24. The coated balloon device of claim 21 wherein the thickness ratio between the undercoat layer, the coating layer, and the top coating is from about 30:

40;

30 to about 10;

85;

5.

25. A coated balloon device for stabilizing a section of a blood vessel in a living subject comprising,

a shaft having a distal end and a proximal end,

a balloon element comprising an extendable structure having an outer surface, the balloon element being supported by the shaft at or near the distal end of the shaft, and

a coating associated with the outer surface of the extendable structure,

wherein the coating comprises a hydrophilic polymer binder and a therapeutic composition blended with the hydrophilic polymer, the therapeutic composition comprising a phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with at least two peripheral phenolic hydroxyl groups.

26. The coated balloon of claim 25 wherein the hydrophilic polymer comprises polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, poly(lactic-co-glycolic acid), or a combination thereof.

27. The coated balloon device of claim 25 wherein the hydrophilic polymer comprises polysaccharide, dextran, starch, hyaluronic acid, collagen, gelatin, chitin, albumin, alginate, as such or as a derivative or a combination thereof.

28. The coated balloon of claim 25 wherein the phenolic compound is tannic acid or an analog of tannic acid, pentagalloylglucose or an analog of pentagalloylglucose, a combination thereof, or a pharmaceutically acceptable salt thereof.

29. The coated balloon of claim 25 wherein at least 25% by weight of the coating comprises the phenolic compound.

30. The coated balloon of claim 25 wherein the coating layer have a thickness from about 20 microns to about 50 microns.

31. The coated balloon of claim 25 wherein the therapeutic composition further comprises glutaraldehyde.

32. The coated balloon of claim 25 wherein the extendable structure comprise a compliant polymer.

33. The coated balloon of claim 25 further comprising a by-pass channel with an opening proximal to the balloon element and an opening distal to the balloon element that provides flow past the balloon when expanded in a vessel.

34. A method for stabilizing a section of a blood vessel of a living subject using a coated balloon having a coating that comprises a therapeutic composition, the method comprising,

deploying the coated balloon at the section of the blood vessel so the coating around a circumference of the balloon is in contact with the blood vessel and keeping the deployed balloon in the blood vessel for a sufficient period of time to allow at least a portion of the therapeutic composition to elute from the coating into the blood vessel to stabilize the blood vessel,

wherein the therapeutic composition comprises a phenolic compound that binds to the elastin component of the blood vessel to stabilize the blood vessel, and

wherein the phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with at least two peripheral phenolic hydroxyl groups.

35. The method of claim 34 wherein the phenolic compound is tannic acid or an analog of tannic acid, pentagalloylglucose or an analog of pentagalloylglucose, a combination thereof, or a pharmaceutically acceptable salt thereof.

36. The method of claim 34 wherein the section of blood vessel comprises an aneurysm.

37. The method of claim 34 further comprising removing the coated balloon from the blood vessel after the blood vessel stabilization procedure.

38. The method of claim 34 wherein the balloon further comprises a sheath and the method further comprises delivering the coated balloon to the section of blood vessel to be stabilized and removing the sheath before deploying the coated balloon.

39. The method of claim 34 further comprising treating the section of the blood vessel with glutaraldehyde before or after the stabilization treatment using the coated balloon.

40. The method of claim 34 further comprising deploying a distal protection device before conducting the blood vessel stabilization procedure to filter the blood flow in the vessel during the procedure.

41. A method of forming a coated balloon that comprises an extendable structure having an outer surface, the method comprising,

applying a coating solution on the outer surface of the extendable structure wherein the coating solution comprises a blend of a hydrophilic polymer and a phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with at least two peripheral phenolic hydroxyl groups.

42. The method of claim 41 wherein the hydrophilic polymer comprises polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, poly(lactic-co-glycolic acid), or a combination thereof.

43. The coated balloon device of claim 41 wherein the hydrophilic polymer comprises polysaccharide, dextran, starch, hyaluronic acid, collagen, gelatin, chitin, albumin, alginate, as such or as a derivative or a combination thereof.

44. The method of claim 41 further comprising applying a hydrophilic undercoat layer on the extendable structure before applying the coating solution.

48. The method of claim 41 further comprising applying a sacrificial top coat on the coating of the coated balloon.

49. The method of claim 41 further comprising drying the coating to form the coated balloon.

45. The method of claim 45 further comprising prior to applying the hydrophilic undercoat layer, associating a crosslinking compound to the outer surface of the extendable structure to crosslink with hydrophilic polymer to form the hydrophilic undercoat layer.

46. The method of claim 45 wherein the crosslinking compound is an aliphatic diisocyanate.

47. The method of claim 45 wherein the crosslinking compound is hexamethylene diisocyanate.