Catheter for removal of an organized embolic thrombus

• US 9,149,609 B2
• Filed: 05/14/2008
• Issued: 10/06/2015
• Est. Priority Date: 10/16/2006
• Status: Active Grant

• Current Assignee: Surmodics MD, LLC (Surmodics Incorporated)
• Original Assignee: Embolitech LLC
• Inventors: Ansel, Gary M., Bonnette, Michael J., Thor, Eric J., Morris, David B., Weisel, Stephen E.
• Primary Examiner(s): RODJOM, KATHERINE MARIE
• Application Number:
  US12/152,367
• Publication Number:
  US 20080312681A1
• Time in Patent Office: 2,701 Days
• Field of Search: 606/108, 606/200
• US Class Current: 1/1
• 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
• 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 embolic thrombus comprising:

a capture sheath;

a flexible capture sleeve having an expanded conformation and an unexpanded conformation;

a grasping mechanism comprising plurality of flexible fingers and having an expanded conformation and an unexpanded conformation, said grasping mechanism attached to the distal end of a first elongated tube;

an elongated guidewire having a proximal end and a distal end and having an occlusion balloon affixed to said elongated guidewire near said distal end, said elongated guidewire being slideable within said grasping mechanism such that said occlusion balloon is extendable distally beyond said grasping mechanism;

wherein said capture sheath, said flexible capture sleeve, said grasping mechanism and said elongated guidewire form a telescopic system; and

wherein said grasping mechanism, in said unexpanded conformation, defines a passageway to and through said first elongated tube; and

wherein at least one of said plurality of flexible fingers includes a serrated edge, an adjacent shorter smooth edge, an opposed serrated edge, and an adjacent opposed shorter smooth edge, wherein an elongated smooth surface is located between said opposed serrated edges and, and an elongated smooth surface is located between said opposed smooth edges.

2. The catheter of claim 1, wherein said grasping mechanism is slideable within said flexible capture sleeve and said flexible capture sleeve is slideable within said capture sheath.

3. The catheter of claim 2, said capture sheath, said flexible capture sleeve, and said grasping mechanism are selectively telescopic.

4. The catheter of claim 1, wherein said plurality of flexible fingers, in said expanded conformation, are spaced apart a maximum amount at a distal end.

5. The catheter of claim 1, wherein each of said plurality of flexible fingers is straight when grasping mechanism is in said expanded conformation.

6. The catheter of claim 5, wherein each of said flexible fingers has an arced cross-section.

7. The catheter of claim 1, wherein said grasping mechanism in an expanded conformation tapers in a distal to proximal direction.

8. The catheter of claim 1, wherein said grasping mechanism is made from nitinol or heat treated stainless steel.

9. The catheter of claim 1, wherein said flexible capture sleeve is attached to a distal end of a second elongated tube.

10. The catheter of claim 9, wherein said flexible capture sleeve is a woven mesh of nitinol strands and polymer strands.

11. The catheter of claim 9, wherein said flexible capture sleeve has an expanded memory shape.

12. The catheter of claim 1, wherein said flexible capture sleeve and said grasping mechanism are in said expanded conformation when said capture sheath does not surround said plurality of flexible fingers and said flexible capture sleeve.

13. The catheter of claim 1, wherein said flexible capture sleeve and said grasping mechanism are in said unexpanded conformation when said capture sheath surrounds said grasping mechanism and said flexible capture sleeve.

14. The catheter of claim 1, wherein said occlusion balloon can be retracted into said flexible capture sleeve.

15. The catheter of claim 1 wherein said occlusion balloon can be retracted into a distal opening of said grasping mechanism in said unexpanded position.

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

a.) providing an elongated catheter with a grasping mechanism at its distal end, wherein , said grasping mechanism is attached to the distal end of a first elongated tube, and wherein an elongated guidewire having a proximal end and a distal end and having an occlusion balloon affixed to said elongated guidewire near said distal end, said elongated guidewire being slideable within said first elongated tube such that said occlusion balloon is extendable distally beyond said grasping mechanism, and wherein said grasping mechanism, in said unexpanded conformation, defines a passageway to and through said first elongated tube, and wherein said grasping mechanism comprises a plurality of flexible fingers, wherein at least one of said plurality of flexible fingers includes a serrated edge, an adjacent shorter smooth edge, an opposed serrated edge, and an adjacent opposed shorter smooth edge, wherein an elongated smooth surface is located between said opposed serrated edges and, and an elongated smooth surface is located between said opposed smooth edges;

b.) inserting said distal end of said elongated catheter into said blood vessel in proximity to said embolic thrombus;

c.) collapsing around at least a portion of said embolic thrombus with said plurality of flexible fingers and reducing said embolic thrombus; and

d.) removing said grasping mechanism and at least a portion of said embolic thrombus from said blood vessel.

17. The method of claim 16, wherein said grasping mechanism has an expanded conformation and an unexpanded conformation and wherein said plurality of flexible fingers collapses around at least a portion of said embolic thrombus when said grasping mechanism moves from an expanded conformation to an unexpanded conformation.

18. The method of claim 17, wherein said opposed smooth edges are configured at a distal portion of each of said plurality of fingers.

19. The method of claim 16, further comprising the steps of providing and inflating an occlusion balloon distal to said embolic thrombus and retracting said occlusion balloon in a proximal direction such that said inflated occlusion balloon contacts and forces said embolic thrombus into said grasping mechanism and at least a portion of said occlusion balloon is retracted into a distal opening of said grasping mechanism.

20. The method of claim 19, further comprising the steps of providing a flexible capture sleeve proximal to embolic thrombus, wherein said flexible capture sleeve has an expanded conformation and an unexpanded conformation, and retracting said occlusion balloon, said embolic thrombus, and said grasping mechanism in a proximal direction into said flexible capture sleeve in said expanded conformation.

21. The method of claim 20, further comprising the steps of deflating said occlusion balloon;

withdrawing said occlusion balloon entirely from said blood vessel; and

finally, withdrawing said grasping mechanism and said flexible capture sleeve with said captured embolic thrombus entirely from said blood vessel.