Rapid aspiration thrombectomy system and method

• US 9,681,882 B2
• Filed: 09/01/2016
• Issued: 06/20/2017
• Est. Priority Date: 03/21/2014
• 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:
  US15/254,857
• Publication Number:
  US 20160367272A1
• Time in Patent Office: 292 Days
• Field of Search: 60416501, 60416502, 60416504, 60416601
• 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: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• 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 25/0054 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 25/0108 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 in a cerebral vessel of a patient, the method comprising:

inserting a catheter system into a blood vessel, the catheter system comprising;

a catheter comprising;

a flexible distal luminal portion having a proximal end, a proximal end region, a proximal opening, a distal end, and a lumen extending between the proximal end and the distal end; and

a proximal elongate body extending proximally from a point of attachment adjacent the proximal opening, wherein the proximal elongate body is less flexible than the flexible distal luminal portion and is configured to control movement of the catheter, wherein the flexible distal luminal portion has an outer diameter at the point of attachment that is larger than an outer diameter of the proximal elongate body at the point of attachment; and

a catheter advancement element comprising;

a flexible elongate body having a proximal end region, a distal tip, a single lumen that communicates with a distal opening in fluid communication with a blood vessel, and an outer diameter, wherein the outer diameter of the flexible elongate body is sized to be received within the lumen of the flexible elongate body of the flexible distal luminal portion of the catheter, and wherein the single lumen extends longitudinally through the flexible elongate body to the distal opening; and

a proximal portion extending from the proximal end region of the flexible elongate body and extending proximally outside of the body of the patient, the proximal portion having a single lumen that communicates with the single lumen of the flexible elongate body;

advancing the catheter system until the distal end of the flexible distal luminal portion of the catheter reaches a target site within the cerebral vessel, wherein at least a portion of the flexible elongate body is disposed within the lumen of the flexible distal luminal portion of the catheter;

removing the flexible elongate body from the lumen of the flexible distal luminal portion of the catheter; and

removing occlusive material while applying a negative pressure to the lumen of the flexible distal luminal portion of the catheter.

2. The method of claim 1, wherein the proximal elongate body of the catheter is solid.

3. The method of claim 1, wherein the proximal elongate body of the catheter is hollow.

4. The method of claim 1, wherein the proximal elongate body of the catheter is a ribbon or a hypotube.

5. The method of claim 1, wherein the flexible elongate body is formed of a malleable material adapted to be shaped by a user.

6. The method of claim 1, wherein the outer diameter of the flexible elongate body is configured to be received within the lumen of the flexible distal luminal portion in a slip fit.

7. The method of claim 6, wherein the outer diameter of the flexible elongate body is between 0.003″

-0.010″

smaller than an inner diameter of the flexible distal luminal portion.

8. The method of claim 1, wherein the distal opening is sized to accommodate a guidewire therethrough.

9. The method of claim 1, wherein the distal tip of the flexible elongate body extends distally beyond the distal end of the flexible distal luminal portion of the catheter during the step of advancing the catheter system.

10. The method of claim 9, wherein the distal tip of the flexible elongate body is tapered providing a substantially smooth transition to the distal end of the flexible distal luminal portion.

11. The method of claim 10, wherein the substantially smooth transition is between a guidewire positioned within the lumen of the flexible elongate body and extending out the distal opening to the distal tip of the flexible elongate body to the distal end of the flexible distal luminal portion.

12. The method of claim 1, wherein the distal tip of the flexible elongate body has a taper.

13. The method of claim 12, wherein the taper of the distal tip of the flexible elongate body has a length between 1.5 cm and 3 cm.

14. The method of claim 1, further comprising a step of inserting a guide sheath into a blood vessel, the guide sheath comprising a lumen of the guide sheath extending between a proximal end region of the guide sheath and a distal end region of the guide sheath, the distal end region of the guide sheath having at least one opening in communication with the lumen of the guide sheath;

and advancing the guide sheath toward the target site.

15. The method of claim 14, wherein the step of inserting the catheter system into the vessel comprises inserting at least a portion of the flexible distal luminal portion of the catheter system into the lumen of the guide sheath positioned within a blood vessel.

16. The method of claim 15, wherein the step of advancing the catheter system comprises extending at least a portion of the flexible distal luminal portion of the catheter out of the at least one opening of the guide sheath until the distal end of the flexible distal luminal portion of the catheter reaches the target site.

17. The method of claim 16, wherein a length of the guide sheath is between 80 cm and 105 cm.

18. The method of claim 17, wherein a length of the flexible distal luminal portion of the catheter is less than the length of the guide sheath.

19. The method of claim 15, wherein the flexible distal luminal portion and the guide sheath are concentrically aligned such that the lumen of the flexible distal luminal portion and the lumen of the guide sheath form a contiguous lumen from the distal end of the flexible distal luminal portion to the proximal end region of the guide sheath.

20. The method of claim 19, wherein the step of removing occlusive material while applying negative pressure comprises applying the negative pressure through the contiguous lumen.

21. The method of claim 19, further comprising a step of delivering a contrast injection through the lumen of the guide sheath.

22. The method of claim 14, wherein the target site is an occlusion or a region near a face of an occlusion.

23. The method of claim 22, further comprising a step of placing the distal end of the flexible distal luminal portion of the catheter on or near the face of the occlusion after removing the flexible elongate body.

24. The method of claim 1, wherein the step of removing occlusive material while applying negative pressure comprises capturing the occlusive material at, within, or through the distal end of the flexible distal luminal portion of the catheter.

25. The method of claim 1, wherein the proximal portion extending from the proximal end region of the flexible elongate body has an outer diameter that is similar to the outer diameter of the flexible elongate body.

26. The method of claim 1, wherein the proximal portion extending from the proximal end region of the flexible elongate body has an outer diameter that is smaller than the outer diameter of the flexible elongate body.

27. The method of claim 1, wherein the proximal elongate body is a spine.

28. The method of claim 1, wherein the outer diameter of the flexible distal luminal portion at a location immediately distal of the point of attachment is larger than the outer diameter of the flexible elongate body at a location immediately proximal the point of attachment.

29. The method of claim 1, wherein the step of removing occlusive material comprises inserting a retrievable stent device through the flexible distal luminal portion of the catheter;

capturing the occlusive material with the retrievable stent device; and

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

30. The method of claim 1, wherein the proximal opening of the flexible distal luminal portion defines an ellipse that lies in a plane that forms an oblique angle in relation to a longitudinal axis of the distal luminal portion, wherein the outer diameter of the flexible distal luminal portion is a diameter of the ellipse defined by the major axis of the ellipse.