Apparatus and methods for treating stroke and controlling cerebral flow characteristics

• US 20030040705A1
• Filed: 04/01/2002
• Published: 02/27/2003
• Est. Priority Date: 08/22/2001
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Dorros, Gerald NMI, Bates, Mark C., Parodi, Juan Carlos
• Granted Patent: US 6,929,634 B2
• Time in Patent Office: Days
• US Class Current: 604/102.02
• 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 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 17/22031 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in the common carotid artery of the hemisphere of the cerebral occlusion. Retrograde flow may be provided through the catheter to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter.

Claims

1. Apparatus suitable for treating stroke, the apparatus comprising:

a catheter having proximal and distal ends, a lumen extending therebetween, and an occlusive element disposed on the distal end, the occlusive element having an opening that communicates with the lumen, the occlusive element having a contracted position suitable for transluminal insertion and an expanded position wherein the occlusive element occludes antegrade flow in a vessel, wherein flow through the lumen of the catheter is configured to influence flow in a cerebral vessel when the catheter is disposed in a carotid artery; and

a deployable wire having proximal and distal ends, and further having a contracted state and a deployed state, wherein the deployable wire is adapted to be inserted into a patient'"'"'s vessel in the contracted state, and wherein the distal end self-deploys to a predetermined shape in the deployed state.

2. The apparatus of claim 1 wherein the occlusive element comprises an inflatable balloon.

3. The apparatus of claim 1 further comprising:

a shaft having proximal and distal ends; and

a balloon having proximal and distal ends, the balloon being disposed near the distal end of the shaft.

4. The apparatus of claim 3 wherein the balloon is adapted to be disposed in a communicating artery.

5. The apparatus of claim 3 wherein the distal end of the balloon is everted.

6. The apparatus of claim 5 wherein the proximal end of the balloon is everted.

7. A method for manipulating cerebral blood flow characteristics, the method comprising:

providing apparatus comprising a catheter having proximal and distal ends, a lumen extending therebetween, and an occlusive element affixed to the distal end;

positioning the distal end of the catheter in a selected vessel in a contracted state;

deploying the occlusive element affixed to the catheter to occlude antegrade flow in the selected vessel; and

providing retrograde flow through the lumen of the catheter to influence flow in a cerebral vessel.

8. The method of claim 7 wherein deploying the occlusive element of the catheter occludes antegrade flow in at least a common carotid artery.

9. The method of claim 7 further comprising:

providing a shaft having proximal and distal ends and a balloon disposed near the distal end of the shaft; and

deploying the balloon in an external carotid artery.

10. Apparatus suitable for treating a vascular occlusion, the apparatus comprising:

a deployable wire having proximal and distal ends, and further having a contracted state and a deployed state, wherein the deployable wire is adapted to be inserted into a patient'"'"'s vessel in the contracted state, and wherein the distal end self-deploys to a predetermined shape in the deployed state; and

an outer sheath having proximal and distal ends, wherein the outer sheath is configured to constrain the deployable wire in the contracted state,

wherein an annulus between the deployable wire and an inner surface of the outer sheath defines a drug delivery lumen that is in fluid communication with the distal end of the outer sheath.

11. The apparatus of claim 10 wherein the deployable wire comprises a shape-memory material.

12. The apparatus of claim 10 wherein the deployable wire further comprises an atraumatic tip affixed to the distal end.

13. The apparatus of claim 12 wherein a space between the distal end of the outer sheath and the atraumatic tip defines a drug delivery port, wherein the drug deliver port is in fluid communication with the drug delivery lumen.

14. The apparatus of claim 10 wherein the outer sheath comprises at least one drug delivery port disposed in a lateral surface of the outer sheath, wherein the drug delivery port is in fluid communication with the drug delivery lumen.

15. The apparatus of claim 10 wherein a distal section of the deployable wire comprises a smaller diameter relative to a proximal section of the deployable wire.

16. The apparatus of claim 15 wherein the deployable wire further comprises a coil disposed about a portion of the distal section.

17. The apparatus of claim 10 wherein the drug delivery lumen is configured to permit the delivery of at least one lytic agent to the distal end of the outer sheath.

18. The apparatus of claim 10 wherein the distal end of the deployable wire comprises a knot shape in the deployed state.

19. The apparatus of claim 10 wherein the deployable wire is substantially flush with an inner wall of a treatment vessel in the deployed state.

20. A method for treating a vascular occlusion, the method comprising:

providing a deployable wire having proximal and distal ends in a contracted state substantially within an outer sheath having proximal and distal ends; and

delivering at least one lytic agent to the occlusion via a drug delivery lumen, wherein the drug delivery lumen is defined by an annulus formed between the deployable wire and an inner surface of the outer sheath.

21. The method of claim 20 further comprising delivering the lytic agent to the occlusion via at least one drug delivery port disposed in a lateral surface of the outer sheath.

22. The method of claim 20 further comprising delivering the lytic agent to the occlusion via a space formed between the distal end of the outer sheath and the distal end of the deployable wire.

23. The method of claim 20 further comprising:

positioning the distal end of the outer sheath at a location distal to the occlusion;

proximally retracting the outer sheath to self-deploy the deployable wire at a location distal to the occlusion; and

proximally retracting the deployable wire to snare a remaining portion of the occlusion.