Rapid aspiration thrombectomy system and method

Patent metadata

Field	Value
Publication number	US-2016367272-A1
Application number	US-201615254857-A
Country	US
Kind code	A1
Filing date	Sep 1, 2016
Priority date	Mar 21, 2014
Publication date	Dec 22, 2016
Grant date	—

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.

First claim

1 . A method of performing a medical procedure in a cerebral vessel of a patient, the method comprising:
inserting a catheter system into a vessel, the catheter system comprising:
a catheter comprising:
a flexible distal luminal portion having a proximal end, a proximal end region, a distal end, and a lumen extending between the proximal end and the distal end; and
a proximal spine extending proximally from the proximal end region, wherein the proximal spine is less flexible than the distal luminal portion and is configured to control movement of the catheter; 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 the vessel, and an outer diameter, wherein the outer diameter is sized to be received within the lumen of the luminal portion of the catheter, and wherein the single lumen extends longitudinally through the elongate body to the distal opening; and
a proximal portion extending from the proximal end region of the 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 luminal portion of the catheter reaches a target site within the cerebral vessel, wherein at least a portion of the elongate body is disposed within the lumen of the catheter; removing the flexible elongate body from the lumen of the distal luminal portion of the catheter; and removing occlusive material while applying a negative pressure to the lumen of the distal luminal portion of the catheter.

2 . The method of claim 1 , wherein the cerebral vessel is selected from the group consisting of a carotid artery, an internal carotid artery, a petrous carotid artery, and a petrous portion of a carotid artery.

3 . The method of claim 1 , wherein the proximal spine of the catheter is solid.

4 . The method of claim 1 , wherein the proximal spine of the catheter is hollow.

5 . The method of claim 1 , wherein the proximal spine of the catheter is a ribbon or a hypotube.

6 . The method of claim 1 , wherein the flexible elongate body is formed of a PEBAX material.

7 . The method of claim 6 , wherein the distal tip of the flexible elongate body comprises a material selected from the group consisting of 35D PEBAX, 40D PEBAX, and 72D PEBAX.

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

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

10 . The method of claim 9 , wherein the outer diameter of the elongate body is between 0.003″-0.010″ smaller than an inner diameter of the distal luminal portion.

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

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

13 . The method of claim 12 , wherein the distal tip of the flexible elongate body is tapered providing a substantially smooth transition to the distal end of the distal luminal portion.

14 . The method of claim 13 , wherein the substantially smooth transition is between a guidewire positioned within the lumen of the elongate body and extending out the distal opening to the distal tip of the elongate body to the distal end of the distal luminal portion.

15 . The method of claim 1 , wherein the distal tip of the elongate body is tapered.

16 . The method of claim 15 , wherein the taper of the distal tip of the elongate body has a length between 1.5 cm and 3 cm.

17 . The method of claim 1 , wherein one or both of the distal luminal portion of the catheter and the elongate body of the catheter advancement element has one or more radiopaque markers.

18 . The method of claim 1 , further comprising the step of inserting a guide sheath into the vessel, the guide sheath comprising a lumen extending between a proximal end region 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; and advancing the guide sheath toward the target site.

19 . The method of claim 18 , wherein the step of inserting the catheter system into the vessel comprises inserting at least a portion of the distal luminal portion of the catheter system into the lumen of the guide sheath positioned within the vessel.

20 . The method of claim 19 , wherein the step of advancing the catheter system comprises extending at least a portion of the distal luminal portion of the catheter out of the opening of the guide sheath until the distal end of the luminal portion of the catheter reaches the target site.

21 . The method of claim 20 , wherein the length of the guide sheath is between 80 cm and 105 cm.

22 . The method of claim 21 , wherein the length of the distal luminal portion of the catheter is less than the length of the guide sheath.

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

24 . The method of claim 23 , wherein the step of removing occlusive material while applying negative pressure comprises applying the negative pressure through the contiguous lumen.

25 . The method of claim 18 , wherein the target site is an occlusion or a region near a face of the occlusion.

26 . The method of claim 25 , further comprising the step of placing the distal end of the luminal portion of the catheter on or near the face of the occlusion after removing the flexible elongate body.

27 . The method of claim 23 , further comprising the step delivering a contrast injection through the lumen of the guide sheath.

28 . 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 distal luminal portion of the catheter.

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

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

Assignees

• Route 92 Medical Inc

Inventors

• Garrison Michi E
• Chou Tony M
• Wilson Scott D

Classifications

• A61M1/84

  Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32) · CPC title

• A61B2017/22079

  with suction of debris · CPC title

• A61M2210/12

  Blood circulatory system · CPC title

• A61B17/22 Primary

  Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for · CPC title

• A61B2017/2212

  having a closed distal end, e.g. a loop · CPC title