Rapid aspiration thrombectomy system and method

• US 9,820,761 B2
• Filed: 02/04/2016
• Issued: 11/21/2017
• 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:
  US15/015,799
• Publication Number:
  US 20160220741A1
• Time in Patent Office: 656 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. An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath, the 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 of the flexible elongate body, and an outer diameter, wherein the outer diameter of the flexible elongate body is sized to be received within the lumen of the flexible distal luminal portion of the catheter, and wherein the single lumen of the flexible elongate body extends longitudinally through the flexible elongate body to the distal opening of the flexible elongate body; and

a proximal portion extending from the proximal end region of the flexible elongate body to a proximal-most end of the catheter advancement element, the proximal portion having a single lumen extending through an entire length of the proximal portion and that communicates with the single lumen of the flexible elongate body,

wherein the catheter advancement element can be inserted into the lumen of the flexible distal luminal portion of the catheter such that the distal tip of the flexible elongate body of the catheter advancement element extends distally beyond the distal end of the flexible distal luminal portion of the catheter.

2. The system of claim 1, wherein, when in use, the proximal portion of the catheter advancement element aligns side-by-side with the proximal elongate body of the catheter.

3. The system of claim 1, wherein the distal tip of the flexible elongate body of the catheter advancement element is tapered.

4. The system of claim 1, wherein the catheter advancement element has a length at least as long as a length of the catheter.

5. The system of claim 1, wherein the catheter advancement element is generally tubular along at least a portion of its length.

6. The system of claim 1, wherein the proximal elongate body of the catheter includes a gripping feature configured for a user to grasp in order to move the catheter through an access sheath.

7. The system of claim 6, wherein the proximal portion of the catheter advancement element includes a tab configured to be locked with the gripping feature on the proximal elongate body of the catheter.

8. The system of claim 7, wherein when the catheter and the catheter advancement element are in a locked configuration they are advanced as a single unit through the access sheath.

9. The system of claim 7, wherein the gripping feature and the tab are removably coupled such that in a locked configuration the tab engages the gripping feature and in an unlocked configuration the tab disengages from the gripping feature.

10. The system of claim 7, wherein the tab is affixed to the catheter advancement element.

11. The system of claim 7, wherein the tab is slideable on the catheter advancement element to accommodate different relative positions between the catheter advancement element and the catheter.

12. The system of claim 1, wherein a distal end region of the catheter advancement element is more flexible and increasingly stiffens towards the proximal end region of the flexible elongate body of the catheter advancement element.

13. The system of claim 1, wherein the proximal portion of the catheter advancement element is configured to be held by a user during use of the system.

14. The system of claim 1, wherein the proximal elongate body of the catheter is solid.

15. The system of claim 1, wherein the proximal elongate body of the catheter is hollow.

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

17. The system of claim 1, wherein the outer diameter of the flexible elongate body of the catheter advancement element is configured to be received within the lumen of the flexible distal luminal portion of the catheter advancement element in a slip fit.

18. The system of claim 17, 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.

19. The system of claim 1, wherein the distal opening of the flexible elongate body of the catheter advancement element is sized to accommodate a guidewire therethrough.

20. The system of claim 1, wherein the distal tip of the flexible elongate body of the catheter advancement element is tapered with a taper that extends over a length between 1.5 cm and 3 cm.

21. The system 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.

22. The system 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.

23. The system of claim 1, wherein the proximal elongate body of the catheter is a spine.

24. The system 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.

25. The system 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 flexible distal luminal portion, wherein the outer diameter of the flexible distal luminal portion is a diameter of the ellipse defined by a major axis of the ellipse.

26. The system of claim 1, wherein the catheter advancement element is generally tubular along its entire length.

27. The system of claim 1, wherein the proximal portion of the catheter advancement element is a hypotube.