Methods and systems for treatment of acute ischemic stroke

• US 10,471,233 B2
• Filed: 02/06/2017
• Issued: 11/12/2019
• Est. Priority Date: 12/23/2013
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Garrison, Michi E., Chou, Tony M.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US15/425,460
• Publication Number:
  US 20170274180A1
• Time in Patent Office: 1,009 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 : single wire changing shape to a gripping configuration
• CPC Class Codes: A61B 2017/320775 : Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/3484 : Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3486 : Balloon
• CPC Class Codes: A61B 2090/062 : penetration depth
• 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 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0037 : characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0175 : having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A system of devices for treating an artery includes an arterial access sheath adapted to introduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body. The system also includes a catheter formed of an elongated catheter body sized and shaped to be introduced via a carotid artery access site into a common carotid artery through the internal lumen of the arterial access sheath. The catheter has an overall length and a distal most section length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.

Claims

1. An aspiration catheter system comprising:

an access sheath comprising a tubular sheath body with a central lumen having an inner diameter, a proximal end and a distal opening,

and a connector operably connected with the sheath body and attachable to an aspiration line that connects to an aspiration source via the connector; and

a catheter comprising a distal portion and a proximal tether extending proximally from a point of attachment between the proximal tether and the distal portion, wherein the distal portion has an inner lumen, and wherein the catheter is configured to extend from a femoral access site to a carotid artery,

wherein the catheter is configured to slide within the central lumen of the sheath body to change the relative position of the catheter within the central lumen and provide for at least a portion of the distal portion to extend outward from the distal opening of the sheath body such that an overlap region is formed between the catheter and the access sheath,

wherein an effective seal is formed in the overlap region by a tight fit between a cylindrical outer surface of the catheter and a cylindrical inner surface of the central lumen of the sheath body, and

wherein an aspiration lumen is collectively formed by the inner lumen of the catheter and the central lumen of the access sheath and aspiration is enabled via the effective seal.

2. The aspiration catheter system of claim 1, wherein the access sheath has an outer diameter ranging from about 6 Fr to about 8 Fr.

3. The aspiration catheter system of claim 1, wherein the inner diameter of the catheter is between about 0.058″

and about 0.072″ and

wherein the inner diameter of the central lumen of the sheath body is between about 0.074″ and

about 0.088″

.

4. The aspiration catheter system of claim 1, wherein the sheath body of the access sheath has a length from about 90 cm to about 120 cm.

5. The aspiration catheter system of claim 1, wherein the aspiration source is a syringe having a volume of at least 30 cc, and wherein a flow rate of at least about 321 mL/min is established when an aspiration pressure through the aspiration lumen is applied by the syringe.

6. The aspiration catheter system of claim 1, wherein the distal portion of the catheter has a first outer diameter and the cylindrical outer surface of the catheter has a second outer diameter that is larger than the first outer diameter.

7. The aspiration catheter system of claim 1, wherein the distal portion of the catheter comprises a step up from a first outer diameter to a larger, second outer diameter located proximal of the first outer diameter.

8. The aspiration catheter system of claim 7, wherein the step up is over a transition section.

9. The aspiration catheter system of claim 8, wherein the transition section is between 3 mm and 10 mm in length.

10. The aspiration catheter system of claim 7, wherein the first outer diameter extends along a distal 10-25 cm and wherein the second outer diameter extends along a remainder of a working length of the distal portion.

11. A method for treating a stroke in a cerebral blood vessel using an aspiration catheter system comprising an access sheath and a catheter slidably engaged with the access sheath, the catheter comprising a proximal end configured to remain in a central lumen of the access sheath and a distal end extending in a distal direction from the proximal end, the catheter further including a proximal tether extending proximally from a point of attachment between the proximal tether and a distal portion of the catheter, wherein the distal portion has an inner lumen the method comprising:

advancing the access sheath into an internal carotid artery via a transfemoral access site of a patient

tracking the distal end of the catheter to a desired location within the cerebral blood vessel by sliding the catheter relative to the access sheath via the transfemoral access site;

forming a seal by a tight fit in an overlap region between a cylindrical outer surface of a region of the catheter and a cylindrical inner surface of the central lumen of the sheath body so as to define an aspiration lumen collectively formed by the central lumen of the access sheath and an inner lumen of the catheter; and

aspirating via the aspiration lumen wherein aspiration through the aspiration lumen is at least partially enabled by the seal.

12. The method of claim 11, wherein the tracking is performed by directing the catheter over a guidewire.

13. The method of claim 11, further comprising deploying a mechanical thrombectomy device extending in a distal direction from the distal end of the catheter.

14. The method of claim 11, wherein the distal portion of the catheter has a first outer diameter and the cylindrical outer surface of the catheter has a second outer diameter that is larger than the first outer diameter.

15. The method of claim 11, wherein the distal portion of the catheter comprises a step up from a first outer diameter to a larger, second outer diameter located proximal of the first outer diameter.

16. The method of claim 15, wherein the step up is over a transition section.

17. The method of claim 16, wherein the transition section is between 3 mm and 10 mm in length.

18. The method of claim 15, wherein the first outer diameter extends along a distal 10-25 cm and wherein the second outer diameter extends along a remainder of a working length of the distal portion.