Rapid aspiration thrombectomy system and method

• US 10,456,555 B2
• Filed: 12/28/2017
• Issued: 10/29/2019
• Est. Priority Date: 02/04/2015
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Garrison, Michi E., Chou, Tony M., Wilson, Scott D.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US15/856,979
• Publication Number:
  US 20180116684A1
• Time in Patent Office: 670 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 17/221 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• 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 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• 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 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• 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 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.

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

advancing the assembled coaxial system of devices together within a petrous portion of an internal carotid artery, wherein the assembled coaxial system is advanced while a guidewire is not present.

2. The method of claim 1, further comprising removing the 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 catheter lumen 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 tapered distal end of the 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 7, wherein the tapered distal end of the inner member tapers over a length between 1 cm and 3 cm.

9. The method of claim 7, wherein a proximal portion extends proximally from the inner member to outside the body of the patient.

10. The method of claim 9, wherein the proximal portion has a third outer diameter that is smaller than the first outer diameter of the inner member.

11. The method of claim 10, wherein the proximal portion is a stiff wire or a hypotube.

12. The method of claim 10, wherein the first outer diameter is between about 0.003″

- about 0.010″

smaller than an inner diameter of the catheter lumen.

13. The method of claim 12, wherein the inner diameter of the catheter lumen is between about 0.040″

to about 0.088″

.

14. 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.

15. The method of claim 14, 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.

16. The method of claim 14, wherein the proximal tether element has sufficient rigidity to push the catheter distally towards the treatment site.

17. The method of claim 14, wherein the proximal tether element is solid or has a lumen.

18. The method of claim 14, 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.

19. The method of claim 18, wherein the advancing the assembled coaxial system 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.

20. The method of claim 18, wherein a length of the flexible distal luminal portion is less than an insertable length of the arterial access device.

21. The method of claim 20, 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.

22. The method of claim 1, further comprising locking the catheter and the inner member into a fixed position relative to one another prior to advancing the assembled coaxial system.

23. The method of claim 22, wherein locking the catheter and the inner member comprises using a mechanical locking element or gripping the catheter and the inner member by hand.

24. The method of claim 23, wherein the mechanical locking element is configured to be placed in a locked configuration to maintain the fixed position and an unlocked configuration to allow for relative sliding.

25. The method of claim 1, further comprising shaping the tapered distal end of the inner member extending distal to the distal end of the catheter, wherein the tapered distal end of the inner member is shaped to an angle relative to a longitudinal axis of the inner member.

26. The method of claim 1, wherein advancing the assembled coaxial system of devices together further comprises advancing the assembled coaxial system of devices together after the distal end of the catheter is advanced distal to the petrous portion of the internal carotid artery.