Catheter for removal of an organized embolic thrombus

• US 20080312681A1
• Filed: 05/14/2008
• Published: 12/18/2008
• Est. Priority Date: 10/16/2006
• Status: Active Grant

• Current Assignee: Surmodics MD, LLC (Surmodics Incorporated)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Morris, David B., Bonnette, Michael J., Thor, Eric J., Weisel, Stephen D., Ansel, Gary M.
• Granted Patent: US 9,149,609 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• 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: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

The general purpose of the present invention is to provide a catheter for removal of an organized embolic thrombus, preferably in conjunction with a distal occlusion balloon guidewire. The present invention consists of three main components including a capture/delivery sheath, a capture sleeve of mesh attached to a tube and a grasping mechanism attached to another tube which is central to the other components. Operative structures in the form of manifolds are connected to such components in order to manipulate and control the relative positions of the capture/delivery sheath, the capture sleeve and the grasping mechanism. An embolic thrombus is engaged by the deployable automatically expanding serrated fingers of a grasping mechanism in combination with a deployable automatically expanding mesh capture sleeve. The capture/delivery sheath is maneuvered to cause compression of the serrated fingers and of the mesh capture sleeve for subsequent removal of the embolic thrombus.

Claims

1. A catheter for removal of an organized embolic thrombus comprising:

a. a first manifold having a longitudinal passageway therethrough;

b. a second manifold having a longitudinal passageway therethrough;

c. a third manifold having a longitudinal passageway therethrough, said second manifold being proximal to said first manifold and said third manifold being proximal to said second manifold;

d. a first flexible elongated tube having a distal end and a proximal end and extending through said longitudinal passageway of each of said manifolds such that its proximal end extends through said third manifold and its distal end extends through said first manifold, said first elongated tube being fixed within said longitudinal passageway of said third manifold;

e. a second flexible elongated tube having a proximal end and a distal end and extending through said longitudinal passageway of each of said second and first manifolds, said proximal end of said second elongated tube being fixed within said longitudinal passageway of said second manifold and said distal end of said second elongated tube extending distally beyond said first manifold;

f. a third flexible elongated tube having a proximal end and a distal end, said proximal end of said third elongated tube being fixed within said longitudinal passageway of said first manifold and said distal end of said third elongated tube extending distally from said first manifold, said first elongated tube being slideable within said second elongated tube and said second elongated tube being slideable within said third elongated tube; and

,

g. a grasping means for grasping said organized embolic thrombus, and said grasping means being attached to said first and second elongated tubes.

2. The catheter of claim 1, wherein said grasping means includes a plurality of flexible fingers attached to said distal end of said first elongated tube and a flexible capture sleeve attached to said distal end of said second elongated tube, said plurality of flexible fingers and said flexible capture sleeve having a memory shape capability.

3. The catheter of claim 2, wherein said grasping means is slideable within said third elongated tube and externally beyond said distal end of said third elongated tube.

4. The catheter of claim 3, wherein each of said flexible fingers has a section with serrated edges.

5. The catheter of claim 4, wherein said plurality of flexible fingers is attached to a flexible joint section which is attached to a tubular section which is attached to said distal end of said first elongated tube.

6. The catheter of claim 4, wherein each of said flexible fingers has a smooth surface and smooth edges beyond said serrated edge section.

7. The catheter of claim 4, wherein there are three flexible fingers.

8. The catheter of claim 5, wherein said plurality of fingers, said flexible joint section and said tubular section are made from nitinol or heat treated stainless steel.

9. The catheter of claim 2, wherein said flexible capture sleeve is attached to said distal end of said second elongated tube.

10. The catheter of claim 2, wherein said flexible capture sleeve is a woven mesh of nitinol strands and polymer strands.

11. The catheter of claim 2, wherein said flexible capture sleeve has an expanded memory shape.

12. The catheter of claim 11, wherein said flexible capture sleeve surrounds said plurality of flexible fingers when said flexible capture sleeve is in an unexpanded condition and is withdrawn completely within said third elongated tube.

13. The catheter of claim 11, wherein said flexible capture sleeve surrounds said plurality of flexible fingers when said flexible capture sleeve is in an expanded condition and is extended beyond said third elongated tube.

14. The catheter of claim 2, wherein said first and second elongated tubes are made from braided polyimide or flexible stainless steel and said third elongated tube is made from a flexible plastic material.

15. The catheter of claim 2, wherein said catheter further comprises a flexible, elongated, tubular guidewire having a proximal end and a distal end, said elongated tubular guidewire being insertable into and slideable within said first elongated tube such that said distal end of said elongated tubular guidewire is extendable distally beyond said distal end of said first elongated tube.

16. The catheter of claim 15, wherein said elongated tubular guidewire has an occlusion balloon near and proximal to said distal end thereof.

17. The catheter of claim 15, wherein said elongated tubular guidewire has an outer diameter of 0.014 inch.

18. The catheter of claim 1, wherein said first, second and third elongated tubes are coaxial with respect to each other.

19. A method for removal of an organized embolic thrombus from within a blood vessel comprising the of steps:

a. providing an elongated catheter with a grasping means at its distal end;

b. inserting said distal end of said elongated catheter into said blood vessel up to the location of said embolic thrombus;

c. grasping said embolic thrombus firmly with said grasping means; and

,

d. removing said grasping means with said embolic thrombus from said blood vessel.

20. The method of claim 19, wherein said grasping means includes a plurality of memory shape fingers for grasping said embolic thrombus and includes the preliminary step prior to the removal of said embolic thrombus:

operating an external manifold to close said plurality of fingers in order to grasp said embolic thrombus.

21. The method of claim 20, wherein said grasping means further includes a memory shape, substantially tubular, capture sleeve and further includes the preliminary step prior to the removal of said embolic thrombus and in conjunction with the closing of said plurality of memory shape fingers unto said embolic thrombus:

operating another external manifold to close said memory shape capture sleeve around said plurality of memory shape fingers and said embolic thrombus.

22. The method of claim 21, wherein said method further includes a flexible, elongated, tubular guidewire with an occlusion balloon near the distal end thereof and further includes the prior steps:

inserting said elongated tubular guidewire into said blood vessel such that said distal end of said elongated tubular guidewire and said occlusion balloon thereof extends distally beyond said embolic thrombus, inserting said distal end of said elongated catheter into said blood vessel over and about said elongated tubular guidewire, inflating said occlusion balloon in said elongated tubular guidewire, withdrawing said elongated tubular guidewire in a proximal direction such that said inflated occlusion balloon contacts and forces said embolic thrombus between said plurality of memory shape fingers and within said memory shape capture sleeve.

23. The method of claim 22, wherein said method further includes the steps of deflating said occlusion balloon;

withdrawing said elongated tubular guidewire entirely from said blood vessel; and

finally, withdrawing said catheter with said captured embolic thrombus entirely from said blood vessel.