Apparatus, material compositions, and methods for permanent occlusion of a hollow anatomical structure

• US 7,402,320 B2
• Filed: 08/26/2005
• Issued: 07/22/2008
• Est. Priority Date: 08/31/2004
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: VNUS Medical Technologies Incorporated (Medtronic Plc)
• Inventors: Mirizzi, Michael Stephan, Prestezog, Anna Grace, Karabey, Halil Ibrahim, McRae, Bob
• Primary Examiner(s): Kennedy; Sharon E.
• Application Number:
  US11/213,202
• Publication Number:
  US 20060052823A1
• Time in Patent Office: 1,061 Days
• Field of Search: 424/422, 424/423, 128/831, 606/157, 606/158, 606/214
• US Class Current: 424/422
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

This invention relates to occlusion of a hollow anatomical structure by inserting an occluding device or occluding material into a hollow anatomical structure or surrounding native tissue.

Claims

1. A method for occluding a hollow anatomical structure in a patient, the method comprising:

reducing an interior cross-sectional area of the hollow anatomical structure by applying a vacuum to an interior of the hollow anatomical structure; and

placing an occluding material at an occlusion site, whereby an occlusion is formed in the hollow anatomical structure.

2. The method of claim 1, further comprising a step of:

identifying an occlusion site, wherein the step of identifying is conducted before the step of placing an occluding material at the occlusion site.

3. The method of claim 1, wherein the occluding material comprises a tissue adhesive.

4. The method of claim 3, wherein the tissue adhesive is a cyanoacrylate adhesive.

5. The method of claim 3, wherein the tissue adhesive is selected from the group consisting of collagen, fibrinogen, fibronectin, vitronectin, laminin, thrombin, gelatin, and mixtures thereof.

6. The method of claim 1, wherein the area is reduced by applying a compression to the hollow anatomical structure.

7. The method of claim 1, wherein the hollow anatomical structure is a blood vessel, and wherein the area is reduced by administering a venoconstrictor to the patient.

8. The method of claim 1 wherein the step of reducing an interior cross-sectional area is conducted before the step of placing an occluding material at the site.

9. The method of claim 1 wherein the step of reducing an interior cross-sectional area is conducted after the step of placing an occluding material at the site.

10. The method of claim 1, wherein the occluding site is near at least one valve in a vein.

11. The method of claim 1, wherein the occluding fluid material comprises a hydrogel, wherein the hydrogel expands in situ to occlude the hollow anatomical structure.

12. The method of claim 1, wherein the step of placing an occluding material comprises the steps of:

placing at least one temporary occluding device in the hollow anatomical structure adjacent to the site;

placing an occluding fluid material at the site adjacent to the temporary occluding device;

solidifying or curing the occluding fluid material, whereby an occlusion is formed in the hollow anatomical structure; and

removing the temporary occluding device.

13. The method of claim 1, wherein the occluding material forms a contiguous occlusion.

14. The method of claim 1, wherein the step of placing an occluding material comprises the steps of:

placing at least one occluding device in the hollow anatomical structure adjacent to the site, whereby a contiguous occlusion is formed;

placing an occluding fluid material at the site adjacent to the occluding device; and

solidifying or curing the occluding fluid material, whereby an occlusion is formed in the hollow anatomical structure.

15. The method of claim 1, wherein the occluding fluid material is placed at at least two separate locations, forming two noncontiguous occlusions.

16. The method of claim 15, wherein a sclerosant is placed between the two noncontiguous occlusions.

17. The method of claim 1, wherein the occlusion site is interior to the hollow anatomical structure.

18. The method of claim 1, wherein the occlusion site is exterior to the hollow anatomical structure.

19. The method of claim 1, wherein the occluding material comprises a collagen plug.

20. The method of claim 1, wherein the occluding material is an alpha-hydroxy acid plug.

21. The method of claim 1, wherein the occluding material comprises a collagen sponge.

22. The method of claim 1, wherein the occluding material is an alpha-hydroxy acid sponge.

23. The method of claim 1, wherein the occluding material includes a therapeutic agent selected from the group consisting of anti-inflammatory agents, anti-infective agents, anesthetics, pro-inflammatory agents, cell proliferative agents, tretinoin, procoagulants, and combinations thereof.

24. The method of claim 1, wherein the occluding material is in a fluid form that cures in situ to form an occlusion in the hollow anatomical structure.

25. The method of claim 1, wherein the occluding material changes viscosity in situ to form an occlusion in the hollow anatomical structure.

26. The method of claim 1, wherein the occluding material is placed in the hollow anatomical structure through a needle.

27. The method of claim 1, wherein the occluding material is placed in the hollow anatomical structure through a catheter.

28. The method of claim 1, wherein the hollow anatomical structure is a vein, further comprising the step of:

placing a sclerosant in the vein.

29. The method of claim 1, wherein the occluding material comprises a sclerosant.

30. The method of claim 29, wherein the occluding material further comprises dimethyl sulfoxide.

31. The method of claim 1, wherein the occluding material is combined with a sclerosant.

32. The method of claim 29, wherein the occluding material is in a form of a sponge, and wherein the sclerosant is contained on or within the sponge.

33. The method of claim 1, wherein the occlusion is a partial occlusion.

34. The method of claim 1, wherein the occlusion is a complete occlusion.

35. The method of claim 1, wherein the hollow anatomical structure is part of the superficial human venous system of the lower extremities.

36. The method of claim 1, wherein the hollow anatomical structure is a vein selected from the group consisting of the great saphenous vein, the small saphenous vein, a perforating vein which connects superficial veins to deep veins in the leg, and a superficial tributary vein of the leg.

37. The method of claim 1, wherein the hollow anatomical structure is selected from the group consisting of telangiectasia, internal spermatic vein, ovarian vein, gonadal vein, hemorrhoidal vessel, esophageal varices, fallopian tube, vas deferens, arteriovenous malformation, arteriovenous fistula network, aortic aneurysm excluded lumens post abdominal aortic aneurysm graft placement, lumbar artery, and feeding vessel into the aorta.

38. The method of claim 1, wherein the step of identifying an occlusion site in a hollow anatomical structure utilizes an identification method selected from the group consisting of ultrasound, compression, palpation, endoscopy, fluoroscopy, and use of contrast media.

39. A method for occluding a hollow anatomical structure in a patient, the method comprising:

placing an occluding material at an occlusion site, whereby an occlusion is formed in the hollow anatomical structure;

wherein the hollow anatomical structure is a vein, and wherein placing an occluding material at the site comprises placing a material in a perivenous space surrounding the vein at the occlusion site, whereby an occlusion is formed in the vein;

wherein the material is shrinkable, and wherein an occlusion is formed in the vein by shrinking the material.

40. The method of claim 39, wherein the material is collagen, and wherein the step of shrinking comprises heating the collagen.

41. The method of claim 39, further comprising reducing an interior cross-sectional area of the vein.

42. The method of claim 41, wherein the area is reduced by applying a vacuum to an interior of the vein.

43. The method of claim 41, wherein the area is reduced by administering a venoconstrictor to the vein.

44. The method of claim 39, further comprising placing a sclerosant in the vein.

45. The method of claim 39, wherein the vein is part of the superficial human venous system of the lower extremities.

46. A method for occluding a hollow anatomical structure in a patient, the method comprising:

placing an occluding material at an occlusion site, whereby an occlusion is formed in the hollow anatomical structure;

wherein the hollow anatomical structure is a vein, and wherein placing an occluding material at the site comprises placing a material in a perivenous space surrounding the vein at the occlusion site, whereby an occlusion is formed in the vein;

wherein the material is an alpha-hydroxy acid.

47. The method of claim 46, further comprising reducing an interior cross-sectional area of the vein.

48. The method of claim 47, wherein the area is reduced by applying a vacuum to an interior of the vein.

49. The method of claim 47, wherein the area is reduced by administering a venoconstrictor to the vein.

50. The method of claim 47, wherein reducing an interior cross-sectional area is conducted before placing an occluding material at the site.

51. The method of claim 47, wherein reducing an interior cross-sectional area is conducted after placing an occluding material at the site.

52. The method of claim 46, further comprising placing a sclerosant in the vein.

53. The method of claim 46, wherein the vein is part of the superficial human venous system of the lower extremities.

54. A method for occluding a hollow anatomical structure in a patient, the method comprising:

placing an occluding material at an occlusion site, whereby an occlusion is formed in the hollow anatomical structure;

wherein the hollow anatomical structure is a vein, and wherein placing an occluding material at the site comprises placing a material in a perivenous space surrounding the vein at the occlusion site, whereby an occlusion is formed in the vein;

wherein the material is collagen.

55. The method of claim 54, further comprising reducing an interior cross-sectional area of the vein.

56. The method of claim 55, wherein the area is reduced by applying a vacuum to an interior of the vein.

57. The method of claim 55, wherein the area is reduced by administering a venoconstrictor to the vein.

58. The method of claim 55, wherein reducing an interior cross-sectional area is conducted before placing an occluding material at the site.

59. The method of claim 55, wherein reducing an interior cross-sectional area is conducted after placing an occluding material at the site.

60. The method of claim 54, further comprising placing a scierosant in the vein.

61. The method of claim 54, wherein the vein is part of the superficial human venous system of the lower extremities.