RAPID ASPIRATION THROMBECTOMY SYSTEM AND METHOD

• US 20160220741A1
• Filed: 02/04/2016
• Published: 08/04/2016
• Est. Priority Date: 03/21/2014
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Chou, Tony M., Garrison, Michi E., Wilson, Scott D.
• Granted Patent: US 9,820,761 B2
• Time in Patent Office: 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 17/221 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:

an aspiration or support catheter comprising;

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; and

a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom; and

a dilator comprising;

a flexible, distal dilator portion sized to be received within the lumen of the luminal portion; and

a rigid, dilator spine extending proximally from the dilator portion.

2. The system of claim 1, wherein, when in use, the dilator spine aligns side-by-side with the spine of the catheter.

3. The system of claim 1, wherein the distal dilator portion has a tapered distal tip.

4. The system of claim 1, wherein the dilator has a length at least as long as a length of the catheter such that a distal tip of the dilator protrudes from the distal opening of the luminal portion.

5. The system of claim 1, wherein the dilator is generally tubular along at least a portion of the length.

6. The system of claim 1, wherein a proximal end of the catheter spine 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 a proximal end of the dilator spine includes a tab configured to be locked with the gripping feature on the catheter spine.

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

10. The system of claim 7, wherein the dilator tab is affixed to the dilator.

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

12. The system of claim 1, wherein the distal dilator portion comprises one or more detents on an outer surface configured to lock with correspondingly-shaped surface features on an inner surface of the luminal portion lumen through which the dilator portion extends.

13. The system of claim 1, wherein the dilator spine and the catheter spine have a similar stiffness and kink-resistance.

14. The system of claim 1, wherein the dilator has a visual marker on a distal end and/or a proximal end of the distal tip.

15. The system of claim 1, wherein a distal end region of the dilator is more flexible and increasingly stiffens towards a proximal end region of the dilator.

16. The system of claim 1, wherein the catheter spine and dilator spine are configured to cause bi-directional sliding movement of the luminal portion through a lumen of an access sheath and navigate the luminal portion into a cerebral vessel to reach a treatment site.

17. An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature, the system comprising:

an access sheath having a sheath body comprising an inner diameter defining a lumen between a proximal end and a distal end of the sheath body, and at least one opening from the lumen near a distal end region of the sheath body; and

an aspiration or support catheter comprising;

a flexible, distal luminal portion having an outer diameter sized for insertion through the lumen of the access sheath, 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, and a length between the proximal opening and the distal opening; and

a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom,

wherein the rigid spine is configured to cause bi-directional sliding movement of the luminal portion through the lumen of the access sheath and out the at least one opening to navigate the luminal portion into a cerebral vessel to reach a treatment site, and

wherein a portion of the outer diameter of the luminal portion fluidly seals with the inner diameter of the access sheath when the distal end of the luminal portion extends into the cerebral vessel to reach the treatment site.

18. The system of claim 17, wherein the luminal portion and the sheath body are concentrically aligned and the lumen of the luminal portion and the lumen of the sheath body form a contiguous aspiration lumen from the distal end of the luminal portion to the proximal end of the sheath body.

19. The system of claim 18, wherein the contiguous aspiration lumen is usable to aspirate fluid and debris from the distal opening of the luminal portion.

20. The system of claim 18, wherein the contiguous aspiration lumen is usable to deliver materials through the distal opening of the luminal portion.

21-95. -95. (canceled)