DEVICES AND METHODS FOR REMOVAL OF ACUTE BLOCKAGES FROM BLOOD VESSELS

• US 20170105743A1
• Filed: 11/28/2016
• Published: 04/20/2017
• Est. Priority Date: 06/13/2014
• Status: Active Grant

• Current Assignee: Neuravi Limited (Johnson & Johnson)
• Original Assignee: Neuravi Limited (Johnson & Johnson)
• Inventors: KEANE, Alan, VALE, David, CASEY, Brendan, GILVARRY, Michael, MCARDLE, Kevin, HOLIAN, Maeve, HARDIMAN, David, KING, Daniel, O'GORMAN, Jacqueline, BRADY, Eamon
• Granted Patent: US 10,792,056 B2
• Time in Patent Office: Days
• 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 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0119 Eversible catheters

Abstract

A catheter has an expansile tip that can be delivered in a constricted form. The increased tip diameter facilitates the aspiration and removal of large clot volumes by increasing the area of the catheter tip that applies aspiration to the clot. The tip comprises a support frame which can be cut from a metal or polymer tube, covered with a thin polymer sleeve 909 containing highly elastic properties. This construction provides good pushability and high compressive resistance. The cut pattern can contain axial connections of the support frame and ring members, which will provide a large level of axial support, lateral flexibility and hoop strength to withstand aspiration. The tip of the device can contain a section proximal of the highly flexible area that can expand to except clot. This potential to increase body diameter facilitates the retrieval of large volume clots while the construction of the catheter provides good column stiffness to avoid axial collapse and still maintain good flexibility.

Claims

1. A catheter having an expansile distal tip, the catheter tip having a constricted delivery configuration and an expanded deployed configuration, and comprising a support frame and an elastic sleeve extending over the frame, the sleeve being expandable in the deployed configuration to define an enlarged distal tip.

2. A catheter as claimed in claim 1 wherein the sleeve is partially folded in the delivery configuration.

3. A catheter as claimed in claim 1 wherein at least a portion of the support frame is configured to expand radially outwardly from the deployed configuration.

4. A catheter as claimed in claim 1 wherein the support frame comprises a flexible region just proximal of the distal tip.

5. A catheter as claimed in claim 1 wherein the support frame is cut from a tube and the cut pattern defines ring members and axially extending connections between the ring members.

6. A catheter as claimed in claim 1 wherein at least a distal region of the support frame comprises a radiopaque material.

7. A catheter as claimed in claim 1 wherein the sleeve comprises a polymeric membrane.

8. A catheter as claimed in claim 7 wherein the membrane has an internal and/or an external low friction coating.

9. A system comprising:

a clot retrieval catheter having a self expanding distal tip which is expansile from a radially retracted delivery configuration to a radially expanded configuration for reception of a clot; and

an access catheter;

the self expanding distal tip being collapsible to a diameter less than or equal to that of the access catheter for delivery through the lumen of the access catheter, and being expandable to a diameter greater than that of the access catheter lumen in an unconstrained state.

10. A system as claimed in claim 9 wherein the catheter comprises an expansile distal tip, the catheter tip having a constricted delivery configuration and an expanded deployed configuration, and comprising a support frame and an elastic sleeve extending over the frame, the sleeve being expandable in the deployed configuration to define an enlarged distal tip.

11. A system as claimed in claim 10 wherein the sleeve is partially folded in the delivery configuration.

12. A system as claimed in claim 10 wherein at least a portion of the support frame is configured to expand radially outwardly from the deployed configuration.

13. A system as claimed in claim 10 wherein the support frame comprises a flexible region just proximal of the distal tip.

14. A system comprising:

a clot retrieval catheter having a distal tip which is expansile from a radially retracted delivery configuration to a radially expanded configuration for reception of a clot; and

a self expanding element having a retracted delivery configuration and an expanded configuration, the self expanding element being axially movable within the catheter from an axially retracted configuration proximal of the distal tip to an axially extended configuration to expand the distal tip of the catheter.

15. A system as claimed in claim 14 wherein the self expanding element is mounted to a proximally extending control element.

16. A system as claimed in claim 15 wherein the control element comprises a control wire extending from the self expanding element.

17. A clot retrieval system comprising an outer access catheter and an inner rapid exchange clot retrieval catheter which is adapted to be advanced through the outer catheter wherein the system comprises a narrowed region which forms a seal between at least a portion of the inner wall of the outer access catheter and at least a portion of an outer region of the inner clot retrieval catheter.

18. A clot retrieval system as claimed in claim 17 wherein the outer catheter comprises a narrowed region which forms a seal between the inner wall of the outer access catheter and the outer wall of the inner clot retrieval catheter.

19. A method of retrieving an obstructive thrombus from a patient'"'"'s blood vessel comprising the steps of:

providing a clot retrieval system comprising an outer access catheter and an inner rapid exchange clot retrieval catheter, the system comprising a narrowed region which forms a seal between at least a portion of the inner wall of the outer access catheter and at least a portion of an outer region of the inner clot retrieval catheter;

advancing the access catheter into the vasculature of the patient;

advancing the rapid exchange clot retrieval catheter through the access catheter;

continuing to advance the rapid exchange clot retrieval catheter until a distal mouth of the rapid exchange clot retrieval catheter is adjacent the proximal face of an obstructive thrombus; and

aspirating through the access catheter to reduce the pressure within the distal mouth of the rapid exchange clot retrieval catheter to urge clot into the catheter mouth.

20. A method as claimed in claim 19 wherein the outer catheter comprises a narrowed region which forms a seal between the inner wall of the outer access catheter and the outer wall of the inner clot retrieval catheter.