Angioplasty device and method of using the same

• US 4,794,928 A
• Filed: 06/10/1987
• Issued: 01/03/1989
• Est. Priority Date: 06/10/1987
• Status: Expired due to Term

• Current Assignee: Harold D. Kletschka
• Original Assignee: Harold D. Kletschka
• Inventors: Kletschka, Harold D.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/061,104
• Time in Patent Office: 573 Days
• Field of Search: 128/344, 128/348.1, 128/305, 128/303.1, 604/101, 604/22, 604/96
• US Class Current: 606/194
• 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 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An angioplasty device is disclosed for treatment of, or for compression and/or removal of an obstruction from, a vessel or vessel-like structure in medical, non-medical and industrial applications. The device incorporates a trap/barrier for trapping and removing particles that break away from the treatment site with traditional angioplasty devices including but not limited to balloons, cutting rotors, fiber meshes, lasers and the like. The device also provides means for removing the trapped particles from the treated vessel. An angioplasty device is also enclosed that incorporates only the trap/barrier and particles removal elements of the previously described device.

A method for treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure is disclosed that utilizes an angioplasty device of the instant invention. A method employing an angioplasty device of the instant invention is also disclosed for preventing particles from escaping from a point of manipulation of a vessel or vessel-like structure.

Claims

1. An angioplasty device for removing an obstruction from a vessel or vessel-like structure comprising:

a. a catheter bundle for insertion into said vessel;

b. an operative member, for removal or compression of said obstruction, connected to said catheter bundle;

c. control means, connected to said operative member, for manipulating said operative member;

d. a trap/barrier connected to said catheter bundle;

e. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and

f. at least one particle removal aperture situated within said trap/barrier for removal of particles.

2. The angioplasty device of claim 1 wherein said operative member is a balloon.

3. The angioplasty device of claim 2 wherein said control means comprises an expansion canal situated within said catheter bundle and connected to said operative member by an expansion aperture.

4. The angioplasty device of claim 2 wherein said expansion means comprises:

i. at least one expansion leaf situated on or within said trap/barrier; and

ii. at least one shroud line connecting said expansion leaf and said balloon,

such that expansion and retraction of said balloon expands and retracts said trap/barrier, respectively, and such that upon partial retraction of said balloon physiologically significant particles are moved toward said trap/barrier by pressure within said vessel.

5. The angioplasty device of claim 2 wherein said expansion means comprises:

i. at least one expansion leaf situated on or within said trap/barrier;

ii. at least one pod, said pod being (A) attached to said expansion leaf and in contact with or attached to said balloon, or (B) attached to said balloon and in contact with or attached to said expansion leaf,

such that expansion and retraction of said balloon expands and retracts said trap/barrier, respectively, and such that upon partial retraction of said balloon physiologically significant particles are moved toward said trap/barrier by pressure within said vessel.

6. The angioplasty device of claim 1 wherein said expansion means comprises an expansion canal situated within said catheter bundle and connected to said trap/barrier.

7. The angioplasty device of claim 1 wherein said control means and said expansion means comprise a bi-functional expansion canal connected to both said operative member and said trap/barrier.

8. The angioplasty device of claim 1 wherein said expansion means comprises a supporting expansion mechanism for expansion of said trap/barrier.

9. The angioplasty device of claim 8 wherein said supporting expansion mechanism comprises at least one expansion stent situated within or on said trap/barrier such that, when the trap/barrier is expanded, said trap/barrier establishes a seal against the inner lining of the vessel.

10. The angioplasty device of claim 9 wherein said supporting expansion mechanism additionally comprises an expansion shaft, situated within said catheter bundle, having an expansion node and a retraction node such that, when said shaft is moved, said expansion node and said retraction node expand and retract, respectively, said trap/barrier.

11. The angioplasty device of claim 1 wherein said trap/barrier comprises a membrane with at least one pore through which no physiologically significant particles can pass.

12. The angioplasty device of claim 1 further comprising a particle removal canal contained within said catheter bundle and wherein said at least one particle removal aperture is connected to said particle removal canal.

13. The angioplasty device of claim 12 wherein said particle removal aperture is integrated into said trap/barrier.

14. The angioplasty device of claim 12 or 13 wherein said particle removal aperture is connected to means for providing a pressure differential between the fluid in said vessel and said particle removal aperture such that fluid containing particles moves into said aperture.

15. The angioplasty device of claim 1 additionally comprising at least one additional canal situated within said catheter bundle, said additional canal being selected from the group of guide wire canals and flow-through canals.

16. An angioplasty device for removing an obstruction from a vessel or vessel-like structure comprising:

a. a catheter bundle for insertion into said vessel;

b. a trap/barrier connected to said catheter bundle;

c. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and

d. at least one particle removal aperture situated within said trap/barrier for removal of particles.

17. The angioplasty device of claim 16 wherein said expansion means comprises an expansion canal situated within said catheter bundle and connected to said trap/barrier.

18. The angioplasty device of claim 16 wherein said expansion means comprises a supporting expansion mechanism for expansion of said trap/barrier.

19. The angioplasty device of claim 18 wherein said supporting expansion means comprises at least one expansion stent situated on or within said trap/barrier such that, when the trap/barrier is expanded, said trap/barrier establishes a seal against the inner lining of the vessel.

20. The angioplasty device of claim 19 wherein said supporting expansion means additionally comprises an expansion shaft, situated within said catheter bundle, having an expansion node and a retraction node such that, when said shaft is moved, said expansion node and said retraction node expand and retract, respectively, said trap/barrier.

21. The angioplasty device of claim 16 wherein said trap/barrier comprises a membrane with at least one pore through which no physiologically significant particles can pass.

22. The angioplasty device of claim 16 further comprising a particle removal canal contained within said catheter bundle and wherein said at least one particle removal aperture is connected to said particle removal canal.

23. The angioplasty device of claim 22 wherein said particle removal aperture is integrated into said trap/barrier.

24. The angioplasty device of claim 22 or 23 wherein said particle removal aperture is connected to means for providing a pressure differential between the fluid in said vessel and said particle removal aperture such that fluid containing particles moves from the vessel into said aperture.

25. The angioplasty device of claim 16 additionally comprising at least one additional canal situated within said catheter bundle, said additional canal being selected from the group of guide wire canals and flow-through canals.

26. A method for treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure comprising:

a. inserting an angioplasty device into said vessel;

b. aligning said device with the site of treatment or the site of the obstruction;

c. manipulating said device such that the desired treatment, removal or compression is achieved;

d. removing any resulting particles through or to within said device;

e. retracting said device; and

f. removing said device from said vessel carrying any collected particles therewith,

said device comprising;

i. a catheter bundle for insertion into said vessel;

ii. an operative member, for removal or compression of said obstruction, connected to said catheter bundle;

iii. control means, connected to said operative member, for manipulating said operative member;

iv. a trap/barrier connected to said catheter bundle;

v. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and

vi. at least one particle removal aperture situated within said

trap/barrier for removal of particles.

27. A method for treatment of, or for removal or compression of an obstruction in, a vessel or vessel-like structure comprising:

a. inserting an angioplasty device into said vessel;

b. aligning said device with the site of treatment or the site of the obstruction;

c. expanding said device such that the desired treatment, removal or compression is achieved;

d. removing any resulting particles through or to within said device;

e. retracting said device; and

f. removing said device from said vessel,

said device comprising;

i. a catheter bundle for insertion into said vessel;

ii. a trap/barrier connected to said catheter bundle;

iii. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and

iv. at least one particle removal aperture situated within said

trap/barrier for removal of particles.

28. A method for preventing particles from escaping from a point of manipulation of a vessel or vessel-like structure comprising:

a. inserting an angioplasty device into said vessel;

b. positioning said device in said vessel;

c. expanding said device;

d. removing any particles resulting from said manipulation of said vessel through or to within said device;

e. retracting said device; and

f. removing said device from said vessel,

said device comprising;

i. a catheter bundle for insertion into said vessel;

ii. a trap/barrier connected to said catheter bundle;

iii. expansion means, connected to said trap/barrier, for expanding and/or retracting said trap/barrier; and

iv. at least one particle removal aperture situated within said trap/barrier for removal of particles.