Methods and systems for treatment of acute ischemic stroke

• US 9,561,345 B2
• Filed: 12/19/2014
• Issued: 02/07/2017
• 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:
  US14/576,953
• Publication Number:
  US 20150173782A1
• Time in Patent Office: 781 Days
• US Class Current: 1/1
• 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 system of devices for treating an artery, comprising:

an arterial access sheath adapted to introduce an interventional catheter into an artery, the arterial access sheath including a sheath body sized and shaped to be introduced into a common carotid artery via a carotid artery access site, the sheath body defining an internal lumen that provides a passageway for introducing a catheter into the common carotid artery when the sheath body is positioned in the common carotid artery, wherein the sheath body has a proximal section and a distalmost section that is more flexible than the proximal section, and wherein a ratio of an entire length of the distalmost section to an overall length of the sheath body is one tenth to one half the overall length of the sheath body;

a tubular, proximal extension having an internal lumen and being connected to a proximal-most end of the sheath body, the proximal extension having a hemostasis valve that provides access to the internal lumen of the proximal extension, wherein the internal lumen of the proximal extension fluidly communicates with the internal lumen of the sheath body when the proximal extension is connected to the sheath body, wherein the proximal extension has an inner diameter and an outer diameter that is larger than an inner diameter and an outer diameter, respectively, of the sheath body so as to form a step between the sheath body and the proximal extension;

an elongated dilator positionable within the internal lumen of the sheath body, wherein the arterial access sheath and the dilator can be collectively introduced into the common carotid artery; and

a first catheter formed of an elongated catheter body having an internal lumen and 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 body sized and shaped to be navigated distally to an intracranial artery through the common carotid artery via the access location in the carotid artery, wherein the catheter body has a length of 40 cm to 70 cm, and wherein the catheter body has a proximal most section and a distal most section wherein the proximal most section is a stiffest portion of the catheter body, and wherein the catheter body 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;

a second catheter having a tubular distal region that fits co-axially into the internal lumen of the first catheter, the tubular distal region having an outer seal that seals with the internal lumen of the first catheter, the second catheter further having a proximal tether wire attached to the tubular distal region and extending in a proximal direction from the tubular distal region, the tether wire being be of sufficient rigidity to push the catheter without buckling.

2. A system as in claim 1, wherein the distal most section of the catheter body is 5 cm to 15 cm in length.

3. A system as in claim 1, wherein the catheter can achieve an aspiration rate of greater than at least 85% in aspiration rate over a catheter having a length of 115 cm and an internal lumen with a diameter of 0.058 inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

4. A system as in claim 1, wherein the interventional catheter can achieve an aspiration rate of greater than at least 71% in aspiration rate over a catheter having a length of 105 cm and an internal lumen with a diameter of 0.072inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

5. A system as in claim 1, wherein the catheter body achieves an actual aspiration rate of at least 205 ml/min for a fluid having the viscosity of human blood at body temperature.

6. A system as in claim 1, wherein the catheter body achieves an actual aspiration rate of at least 321 ml/min for a fluid having the viscosity of human blood at body temperature.

7. A system as in claim 1, wherein the interventional catheter can achieve an actual aspiration rate of greater than at least 59% in aspiration rate over a catheter having a length of 115 cm and an internal lumen with a diameter of 0.058 inch.

8. A system as in claim 1, wherein the interventional catheter can achieve an actual aspiration rate of greater than at least 23% in aspiration rate over a catheter having a length of 105 cm and an internal lumen with a diameter of 0.072 inch.

9. A system as in claim 1,

wherein the sheath body is stepped such that a distal region of the sheath body has a reduced diameter relative to a larger diameter proximal region of the sheath body;

and

wherein the catheter body is also stepped such that a distal region of the catheter body has a reduced diameter relative to a larger diameter proximal region of the catheter body.

10. A system as in claim 9, wherein both an inner diameter and outer diameter of the catheter body is stepped.

11. A system as in claim 9, wherein the larger diameter proximal region of the catheter body has a diameter that is between 10-25% larger than a diameter of the distal region of the catheter body.

12. A system as in claim 9, wherein the distal region of the catheter body is 10-25 cm in length.

13. A system as in claim 9, wherein the interventional catheter can achieve an aspiration rate of greater than at least 179% in aspiration rate over a catheter having a length of 115 cm and an internal lumen with a diameter of 0.058 inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

14. A system as in claim 9, wherein the interventional catheter can achieve an aspiration rate of greater than at least 128% in aspiration rate over a catheter having a length of 105 cm and an internal lumen with a diameter of 0.072 inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

15. A system as in claim 1, wherein the catheter is telescopically attached to the arterial access sheath such that the catheter can telescopically extend in a distal direction out of a distal end of the arterial access sheath along a longitudinal axis of the arterial access sheath to form a continuous inner lumen between the arterial access sheath and the catheter, wherein the catheter can be telescopically retracted such that the catheter does not extend past the distal end of the arterial access device.

16. A system as in claim 1, wherein the sheath body is 15-30 cm and the catheter is 10 to 15 cm in length.

17. A system as in claim 15, wherein the interventional catheter can achieve an aspiration rate of greater than at least 337% in aspiration rate over a catheter having a length of 115 cm and an internal lumen with a diameter of 0.058 inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

18. A system as in claim 15, wherein the interventional catheter can achieve an aspiration rate of greater than at least 251% in aspiration rate over a catheter having a length of 105 cm and an internal lumen with a diameter of 0.072 inch, wherein aspiration rate is calculated pursuant to Poiseuille'"'"'s law for laminar flow in a tube for a fluid having the viscosity of human blood at body temperature.

19. A system as in claim 1, wherein the proximal extension is removably connected to the sheath body.

20. A system as in claim 1, wherein the proximal extension is fixedly connected to the sheath body.

21. A system as in claim 1, wherein the dilator has a distalmost section that is more flexible than a proximalmost section of the dilator.

22. A system as in claim 1, wherein the tether wire includes an internal lumen.