Methods and systems for treatment of acute ischemic stroke

• US 10,213,582 B2
• Filed: 12/19/2017
• Issued: 02/26/2019
• 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
• Application Number:
  US15/847,255
• Publication Number:
  US 20180133436A1
• Time in Patent Office: 434 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
• 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
• 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. A method of performing a medical procedure at a treatment site in a cerebral vessel of a patient, the method comprising:

assembling a coaxial system of devices, the assembled coaxial system of devices comprising;

a catheter having a catheter lumen and a distal end; and

a tapered inner member extending through the catheter lumen, wherein a distal end of the tapered inner member extends distal to the distal end of the catheter, the tapered inner member having a lumen; and

advancing the assembled coaxial system of devices together through the internal carotid artery from a transfemoral access site of the patient;

further advancing the assembled coaxial system of devices together after the distal end of the catheter is distal to a petrous portion of the internal carotid artery.

2. The method of claim 1, further comprising removing the tapered inner member after the catheter is placed at or near the treatment site.

3. The method of claim 2, further comprising advancing a treatment device into the lumen of the catheter so that the treatment device resides at or near the treatment site.

4. The method of claim 2, further comprising removing occlusive material while applying a negative pressure to the catheter lumen to capture occlusive material at, within, or through the distal end of the catheter.

5. The method of claim 4, wherein the step of removing occlusive material comprises:

inserting a retrievable stent device through the catheter;

capturing the occlusive material with the retrievable stent device; and

removing the occlusive material and the retrievable stent device from the treatment site.

6. The method of claim 1, wherein the cerebral vessel is an intracranial vessel and wherein the treatment site is an occlusion or a region near a face of an occlusion within the intracranial vessel.

7. The method of claim 1, wherein the distal end of the tapered inner member tapers distally from a first outer diameter to a second outer diameter that is smaller than the first outer diameter.

8. The method of claim 1, wherein the tapered inner member further comprises a proximal portion extending proximally from the tapered inner member to outside the body of the patient, the proximal portion having a single lumen that communicates with the lumen of the tapered inner member.

9. The method of claim 1, wherein the catheter comprises a flexible distal luminal portion and a proximal tether element extending proximally from a point of attachment near a proximal end of the flexible distal luminal portion, the proximal tether element extending proximally to outside the body of the patient.

10. The method of claim 9, wherein an outer diameter of the proximal tether element at the point of attachment is smaller than an outer diameter of the distal luminal portion at the point of attachment.

11. The method of claim 9, wherein the proximal tether element has sufficient rigidity to push the catheter distally towards the treatment site.

12. The method of claim 9, wherein the proximal tether element is solid or has a lumen.

13. The method of claim 9, further comprising:

introducing through an insertion site of the patient an arterial access device, the arterial access device comprising an elongate body sized and shaped to be introduced into a carotid artery, the elongate body defining an internal lumen and a distal end; and

advancing the arterial access device into the carotid artery.

14. The method of claim 13, wherein the advancing step is performed after the arterial access device is advanced into the carotid artery and further comprises:

inserting the assembled coaxial system into the internal lumen of the elongate body; and

advancing the assembled coaxial system of devices through the internal lumen and past the distal end of the arterial access device.

15. The method of claim 13, wherein a length of the flexible distal luminal portion is less than an insertable length of the arterial access device.

16. The method of claim 15, wherein the insertable length of the arterial access device is between 80 cm and 120 cm and the length of the flexible distal luminal portion is between 10 cm and 25 cm or between 25 cm and 50 cm.

17. The method of claim 1, wherein advancing the assembled coaxial system of device comprises advancing them together over a guidewire.

18. The method of claim 1, wherein the assembled coaxial system of devices further comprises a guidewire positioned within the lumen of the tapered inner member during the advancing step.

19. The method of claim 1, wherein the assembled coaxial system of devices further comprises a guidewire positioned within the lumen of the tapered inner member such that a distal end of the guidewire protrudes from the distal end of the tapered inner member during the advancing step.