Rapid aspiration thrombectomy system and method

• US 10,485,952 B2
• Filed: 11/07/2017
• Issued: 11/26/2019
• 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:
  US15/805,673
• Publication Number:
  US 20180064453A1
• Time in Patent Office: 749 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 in a cerebral vessel of a patient, the method comprising:

inserting a guidewire into a blood vessel;

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

a catheter comprising;

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

a proximal elongate body that is less flexible than the flexible 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 having a taper, a single lumen that communicates with a distal opening in fluid communication with the blood vessel, and an outer diameter, wherein the outer diameter of the flexible elongate body is between about 0.003″

—

about 0.010″

smaller than an inner diameter of 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; 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;

wherein the catheter system is configured to receive the guidewire such that the guidewire extends through the single lumen of the proximal portion of the catheter advancement element and through the single lumen of the flexible elongate body of the catheter advancement element, and wherein a portion of the guidewire is configured to extend out of the distal opening of the flexible elongate body of the catheter advancement element, and wherein the distal tip of the catheter advancement element is configured to form a smooth transition in flexibility between (1) a flexibility of the distal end of the flexible distal luminal portion of the catheter and (2) a flexibility of the portion of the guidewire extending outside the distal opening;

advancing the catheter system distal to a petrous portion of an internal carotid artery 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 to capture the occlusive material at, within, or through the distal end of the flexible distal luminal portion of the catheter.

2. 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.

3. The method of claim 2, wherein the proximal portion is a stiff wire or hypotube.

4. The method of claim 1, wherein the inner diameter of the lumen of the catheter is between about 0.040″

to about 0.088″

.

5. The method of claim 1, wherein the flexible elongate body has an inner diameter of between 0.020″

and about 0.024″ and

is sized to receive the guidewire, wherein the guidewire has an outer diameter of between 0.014″ and

about 0.018″

.

6. The method of claim 1, wherein the taper of the distal tip of the flexible elongate body has a length between 1 cm and 3 cm.

7. The method of claim 1, further comprising locking the catheter and the catheter advancement element into a fixed position relative to one another during advancing the catheter system.

8. The method of claim 7, wherein the fixed position comprises at least a portion of the distal tip extending distally beyond the distal end of the flexible distal luminal portion during at least a portion of the advancing the catheter system.

9. The method of claim 8, wherein the taper of the distal tip of the flexible elongate body has a length between 1 cm and 3 cm.

10. The method of claim 7, wherein locking the catheter and the catheter advancement element comprises using a mechanical locking element or gripping the catheter and catheter advancement element by hand.

11. The method of claim 10, 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 between the catheter and the catheter advancement element.

12. The method of claim 11, wherein when the distal end of the flexible distal luminal portion of the catheter reaches the target site, the mechanical locking element is placed in the unlocked configuration in order to remove the flexible elongate body from the lumen of the flexible distal luminal portion of the catheter.

13. The method of claim 1, wherein the cerebral vessel is an intracranial vessel and wherein the target site is an occlusion or a region near a face of an occlusion within the intracranial vessel.

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 advancing the guide sheath toward the target site comprises advancing the guide sheath to a common carotid artery.

16. The method of claim 15, further comprising:

assembling the catheter advancement element through the lumen of the catheter and assembling the guidewire through the single lumen of the flexible elongate body forming a coaxial system of devices including the catheter, the catheter advancement element, and the guidewire;

inserting the coaxial system of devices into the lumen of the guide sheath; and

advancing the coaxial system of devices through the guide sheath until at least a portion of the flexible distal luminal portion of the catheter extends out of the at least one opening of the guide sheath and the distal end of the flexible distal luminal portion of the catheter reaches the target site.

17. 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.

18. The method of claim 1, wherein a guide catheter is not present distal to the petrous portion of the internal carotid artery while the catheter system is advanced distal to the petrous portion of the internal carotid artery.