Sticky dilatation balloon and methods of using

• US 20090112239A1
• Filed: 10/31/2008
• Published: 04/30/2009
• Est. Priority Date: 10/31/2007
• Status: Abandoned Application

• Current Assignee: Specialized Vascular Technologies, Inc.
• Original Assignee: Specialized Vascular Technologies, Inc.
• Inventors: To, John Thao
• Application Number:
  US12/262,409
• Publication Number:
  US 20090112239A1
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61B 2017/00982 General structural features
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The present invention involves an expandable element with an outer sticky surface. The expandable element may be in the form of a balloon with deflated and inflated configurations. The expandable element serves to both dilate a lumen in a blood vessel thereby opening it and to exert force upon the sticky surface in order to press it into apposition against a vessel wall. The outer sticky surface may be provided directly upon the expandable element or on a separate outer sheath that conforms to and follows the contours of the expandable element. The sticky surface may take the form of a biochemical composition and/or a mechanically abrasive structure such as microhooks, hairs, mesh netting, etc. Optionally, additional expandable elements may be provided proximal and distal to the main element to occlude blood flow on either side of a lesion in order to better trap emboli for collection.

Claims

1. A device for dilating narrowed blood vessels comprising:

a proximal end and a distal end;

a balloon on a catheter; and

an adhesive surface outside of the balloon.

2. The device of claim 1, further comprising at least one port within the catheter for introducing or removing a gas, a liquid, a solid or a hybrid substance.

3. The device of claim 2, wherein at least one port is for providing vacuum suction to remove debris trapped to the adhesive surface in order to create space for more debris to be trapped.

4. The device of claim 2, wherein at least one port is for locally delivering a therapeutic agent or drug to a narrowed region of a blood vessel.

5. The device of claim 1, wherein the balloon is dumbbell shaped.

6. The device of claim 1, further comprising shielding scales or protective microstructures outside the adhesive surface outside of the balloon;

wherein the scales or microstructures are configured to shield or protect the adhesive surface during delivery of the device such that during delivery the non-exposed adhesive surface is prevented from collecting debris and filling up too quickly; and

the scales or microstructures are also configured to peel back, retract, and/or dissolve after implantation of the device in a desired target location in order to expose the adhesive surface so that it then collects material.

7. The device of claim 6, wherein the scales or microstructures are configured to peel back, retract, and/or dissolve upon inflation of the balloon.

8. The device of claim 1, further comprising a treatment element extendable from the catheter in a vicinity of the balloon for providing therapy to and severing tissue.

9. The device of claim 8, wherein the treatment element is selected from the group consisting of:

a blade, an electrode, and a radiation-emitting probe.

10. The device of claim 1, wherein the adhesive surface exists on the balloon itself.

11. The device of claim 1, further comprising an expandable sheath covering the balloon, wherein the adhesive surface exists on the expandable sheath.

12. The device of claim 1, wherein the balloon is both collapsable and inflatable and the adhesive surface is configured to adhere or stick to tissue and debris;

and

further comprising a retractable sheath covering the balloon in its collapsed configuration during delivery.

13. The device of claim 1, wherein the adhesive surface comprises a sticky chemical and/or biological composition.

14. The device of claim 13, further comprising a thin layer of non-stick, porous, compressible foam over the sticky composition, wherein upon application of a threshold amount of pressure, the sticky composition is dispensed through the foam layer to bond tissue fragments and debris to the balloon.

15. The device of claim 1, wherein the adhesive surface comprises mechanically abrasive elements.

16. The device of claim 13, wherein the adhesive surface further comprises mechanically abrasive elements in addition to the sticky chemical and/or biological composition.

17. The device of claim 16, wherein the mechanically abrasive elements protrude from the adhesive surface and the sticky chemical and/or biological composition is coated on the protruding mechanically abrasive elements.

18. The device of claim 16, wherein the mechanically abrasive elements protrude from the surface of the sticky composition and are compressible like springs, such that upon application of a threshold amount of pressure they deflect into the composition to expose it for binding debris.

19. The device of claim 13, wherein the sticky composition is bonded to a surface beneath it.

20. The device of claim 19, wherein the bonding is selected from the group consisting of:

covalent bonding, hydrogen bonding, and a combination thereof.

21. The device of claim 13, wherein the sticky composition takes the form of 3,4-L-dihydroxyphenylalanine.

22. The device of claim 13, wherein the sticky composition takes the form of poly(dopamine methacrylamide-co-methoxyethylacrylate).

23. The device of claim 13, wherein the sticky composition comprises at least one element selected from the group consisting of:

dihydroxyphenyl, hydroxyphenylalanine, albumin, collagen, fibrin, fibrinogen, cyanoacrylate, acrylated urethane, polyurethane, silicone, elastomeric rubber, epoxy, a water-activated adhesive, and a pressure-activated adhesive.

24. The device of claim 15, wherein the mechanically abrasive elements take the form of microhooks.

25. The device of claim 12, wherein the retractable sheath is configured to be rolled back to expose the adhesive surface.

26. The device of claim 1, further comprising an expandable element on the catheter for occluding blood flow beyond the balloon.

27. The device of claim 1, further comprising an expandable filter on the catheter distal to the balloon for filtering material received by the balloon.

28. The device of claim 1, wherein the adhesive surface is bound to a coating that detaches from the balloon and transfers to bind to a luminal wall of a vessel following inflation and deflation of the balloon.

29. The device of claim 28, wherein the detachable coating comprises aligned microfibers or aligned nanofibers.

30. The device of claim 29, wherein the aligned fibers are arranged such that outer fibers are approximately perpendicular to an axis of the vessel and inner fibers are approximately parallel with an axis of the vessel.

31. The device of claim 29, wherein the aligned fibers are biodegradable.

32. The device of claim 29, wherein the aligned fibers are composed of a material selected from the group consisting of:

polylactic acid, polyglycolic acid, polycaprolactone, polyvalerate, polyhydroxybutyriate, polydioxanone, polyanhydrides, poly-ortho esters, polyiminocarbonates, polyetheresters, silk, modified collagen, any blend of the aforementioned polymers, and any co-polymers of the aforementioned polymers.

33. The device of claim 28, further comprising a bioactive substance embedded within the detachable coating.

34. The device of claim 33, wherein the bioactive substance comprises at least one element selected from the group consisting of:

heparin, ticlopidine, chlopidogrel, enoxaparin, dalteparin, hirudin, bivalirudin, argatroban, danparoid, Tissue Factor Pathway Inhibitor (TFPI), rapamycin analogs, antisense dexamethasone, angiopeptin, nicotine, acetylsalicylic acid, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, antifibrosis agents, high density lipoprotein, and estradiol.

35. The device of claim 33, wherein the bioactive substance comprises at least one element selected from the group consisting of:

Batimistat, Biolimus, Everolimus, Halofuginon Rapamycin, Tacrolimus, Taxan™

, Taxol™

, Tranilast, Translast, and Zotarolimus.

36. A device for dilating narrowed blood vessels comprising:

a balloon on a catheter; and

at least one debris trapping structure outside of the balloon.

37. The device of claim 36, wherein the debris trapping structure exists on an outside surface of the balloon itself.

38. The device of claim 36, further comprising an expandable sheath covering the balloon, wherein the debris trapping structure exists on the expandable sheath.

39. The device of claim 36, wherein the balloon is both collapsable and inflatable and the debris trapping structure is configured to adhere or stick to tissue and debris;

and

further comprising a retractable sheath covering the balloon in its collapsed configuration during delivery.

40. The device of claim 36, wherein the debris trapping structure is a microhook.

41. The device of claim 40, wherein the microhook is 12 microns to 250 microns in thickness and 1000 microns to 4000 microns in height.

42. The device of claim 36, wherein the debris trapping structure comprises at least one element selected from the group consisting of:

hairs, loops, nano/micro fibers, aligned nano/micro fibers, meshes, nano/micro suction cups, foam, soft gel layer(s), viscous gel layer(s), weaves, braids, swirls, helical coils, nano/micro bumps, nano/micro pits, nano/micro jaws, and nano/micro tubes.

43. The device of claim 36, wherein the debris trapping structure is hydrophobic.

44. The device of claim 36, wherein the debris trapping structure is amphipathic.

45. The device of claim 36, wherein the debris trapping structure is a hair with split ends.

46. The device of claim 36, wherein the debris trapping structure is coated with an adhesive layer.

47. The device of claim 46, wherein a thickness of the adhesive layer is less than a height of the debris trapping structure(s).

48. The device of claim 46, wherein the adhesive layer comprises 3,4-L-dihydroxyphenylalanine.

49. The device of claim 46, wherein the adhesive layer comprises poly(dopamine methacrylamide-co-methoxyethylacrylate).

50. The device of claim 46, wherein the adhesive layer comprises at least one element selected from the group consisting of:

dihydroxyphenyl, hydroxyphenylalanine, albumin, collagen, fibrin, fibrinogen, cyanoacrylate, acrylated urethane, polyurethane, silicone, elastomeric rubber, epoxy, a water-activated adhesive, and a pressure-activated adhesive.

51. The device of claim 36, wherein the debris trapping structure is an expandable mesh.

52. The device of claim 39, wherein the retractable sheath is configured to be rolled back to expose the debris trapping structure.

53. The device of claim 36, further comprising an expandable element on the catheter for occluding blood flow beyond the balloon.

54. The device of claim 36, further comprising an expandable filter on the catheter distal to the balloon for filtering material received by the balloon.

55. The device of claim 36, wherein the debris trapping structure is bound to a coating that detaches from the balloon and transfers to bind to a luminal wall of a vessel following inflation and deflation of the balloon.

56. The device of claim 55, wherein the detachable coating comprises aligned microfibers or aligned nanofibers.

57. The device of claim 56, wherein the aligned fibers are arranged such that outer fibers are approximately perpendicular to an axis of the vessel and inner fibers are approximately parallel with an axis of the vessel.

58. The device of claim 56, wherein the aligned fibers are biodegradable.

59. The device of claim 56, wherein the aligned fibers are composed of a material selected from the group consisting of:

polylactic acid, polyglycolic acid, polycaprolactone, polyvalerate, polyhydroxybutyriate, polydioxanone, polyanhydrides, poly-ortho esters, polyiminocarbonates, polyetheresters, silk, modified collagen, any blend of the aforementioned polymers, and any co-polymers of the aforementioned polymers.

60. The device of claim 55, further comprising a bioactive substance embedded within the detachable coating.

61. The device of claim 60, wherein the bioactive substance comprises at least one element selected from the group consisting of:

heparin, ticlopidine, chlopidogrel, enoxaparin, dalteparin, hirudin, bivalirudin, argatroban, danparoid, Tissue Factor Pathway Inhibitor (TFPI), rapamycin analogs, antisense dexamethasone, angiopeptin, nicotine, acetylsalicylic acid, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, antifibrosis agents, high density lipoprotein, and estradiol.

62. The device of claim 60, wherein the bioactive substance comprises at least one element selected from the group consisting of:

Batimistat, Biolimus, Everolimus, Halofuginon, Rapamycin, Tacrolimus, Taxan™

, Taxol™

, Tranilast, Translast, and Zotarolimus.

64. A method for dilating narrowed blood vessels using the device according to claim 36, comprising the steps of:

placing a balloon covered with at least one debris trapping structure within a narrow region defined by an inner lumen of a blood vessel;

inflating the balloon; and

deflating the balloon.

65. The method of claim 64, further comprising the step of collapsing a cover over the balloon after deflating the balloon.

66. The method of claim 64, wherein the debris trapping structure is a sticky coating.

67. The method of claim 66, wherein during the step of deflating the balloon the coating detaches from the balloon and transfer to bind to a luminal wall of the vessel.

68. The method of claim 64, further comprising the step of pulling back a sheath covering the balloon in its collapsed condition in order to uncover the balloon before inflating.

69. The method of claim 64, further comprising the step of rolling off a sheath covering the balloon in its collapsed condition in order to uncover the balloon before inflating.

70. The method of claim 64, wherein the debris trapping structure is a mesh, and further comprising the steps of expanding the mesh at the same time as or prior to expansion of the balloon and collapsing the mesh at the same time as or after deflating the balloon.

71. The method of claim 64, further comprising the steps of extending and expanding an element to occlude blood flow beyond the balloon prior to inflating the balloon to prevent blood flow from interfering with inflation.

72. The method of claim 64, further comprising the step of deploying an expandable filter distal to the balloon prior to inflating the balloon to reduce an initial flux of materials directed at the balloon and to prevent the debris trapping structure(s) from becoming filled too quickly.

73. A method for dilating narrowed blood vessels using the device according to claim 61, comprising the steps of:

inserting a catheter with a wire basket on its distal end into a narrowed blood vessel;

shortening a longitudinal length of the wire basket to expand spaces between adjacent wires thereby radially expanding a central region of the basket;

trapping excess tissue and other debris within the expanded spaces between adjacent wires;

elongating the longitudinal length of the wire basket to contract spaces between adjacent wires thereby radially shrinking the central region of the basket;

severing trapped excess tissue and other debris as adjacent wires move together such that the tissue and debris falls within the basket; and

removing the severed tissue and debris from the basket.

63. A device for dilating narrowed blood vessels comprising a basket on a catheter,

wherein the basket is composed of wires and the basket is configured to be reversibly shortened and lengthened by manipulating the wires,

wherein shortening the basket expands a center part of the basket to dilate a lumen and opens spaces between wires to receive tissue and debris, and

wherein lengthening the basket brings the wires closer together to reduce the spaces between them and causes a scissoring effect between wires that severs tissue.