US-12622713-B2 - Methods and systems for treatment of acute ischemic stroke

US12622713B2US 12622713 B2US12622713 B2US 12622713B2US-12622713-B2

Abstract

Described are methods and systems for transcervical access of the cerebral arterial vasculature and treatment of cerebral occlusions, including ischemic stroke. The methods and devices may include methods and devices which may provide aspiration and passive flow reversal, those which protect the cerebral penumbra during the procedure to minimize injury to brain, as well as distal catheters and devices to remove an occlusion. The methods and devices that provide passive flow reversal may also offer to the user a degree of flow control. Devices and methods which provide a way to securely close the access site in the carotid artery to avoid the potentially devastating consequences of a transcervical hematoma are also described.

Inventors

Michi E. Garrison
Tony M. Chou

Assignees

ROUTE 92 MEDICAL, INC.

Dates

Publication Date: 20260512
Application Date: 20250314

Claims (16)

1 . A system for intracranial access through a patient's vasculature to access an intracranial occlusion, the system comprising: a distal access catheter comprising a distal end forming a leading edge, the distal access catheter having an inner diameter of 0.070″-0.095″; and an inner member for advancing the distal access catheter through the patient's vasculature to a terminal portion of an internal carotid artery, the inner member having a proximal section and a distal tip region having a tapered section, wherein an axis of the inner member passes centrally through the proximal section and through the distal tip region, wherein the proximal section, proximal to the distal tip region, has a cylindrical surface having an outer diameter greater than the distal tip region, wherein the proximal section is configured to advance the inner member through the patient's vasculature, and wherein the distal tip region having the tapered section has a size and a flexibility configured to reach the intracranial occlusion, wherein the proximal section and the distal tip region forming a single-lumen passage having a single distal opening configured for passage and relative movement of a wire, wherein, in use, the cylindrical surface of the inner member is maintained at least partially distal of the distal end of the distal access catheter during advancement through the patient's vasculature, and wherein the outer diameter of the cylindrical surface is sized to substantially correspond to the inner diameter of the distal access catheter to prevent separation between the inner member and the leading edge of the distal access catheter while the distal access catheter is advanced through at least a curved portion of the patient's vasculature, and wherein the cylindrical surface has a length to allow axial movements of the inner member relative to the distal access catheter while the distal access catheter is advanced through the curved portion of the patient's vasculature without causing separation of the inner member from the inner diameter of the distal access catheter.
2 . The system of claim 1 , wherein the inner member is composed of a flexible material.
3 . The system of claim 1 , wherein the distal tip region of the inner member prevents a diameter mismatch between an outer diameter of the wire and the inner diameter at the distal end of the distal access catheter.
4 . The system of claim 1 , wherein the wire has an outer diameter of 0.014 inch-0.018 inch.
5 . The system of claim 1 , wherein the single-lumen passage has a diameter between 0.020 inch and 0.024 inch.
6 . The system of claim 1 , further comprising a radiopaque marker disposed near a distal end of the distal tip region.
7 . The system of claim 6 , wherein the radiopaque marker is fabricated from a material selected from the group consisting of platinum/iridium, tungsten, platinum, and tantalum-impregnated polymer.
8 . The system of claim 1 , wherein the inner member is constructed with variable stiffness, wherein a distal segment of the inner member is constructed of a softer material with successively stiffer materials towards a proximal end of the inner member.
9 . The system of claim 1 , wherein a flexibility of the distal tip region of the inner member decreases proximally and creates a smooth transition between a flexibility of the inner member to a flexibility of the distal access catheter.
10 . The system of claim 1 , wherein the distal tip region having the tapered section further comprises a tubular extension located distally past the tapered section.
11 . The system of claim 10 , wherein the tubular extension has a uniform outer diameter.
12 . A method of accessing an intracranial occlusion through a patient's vasculature, the method comprising: advancing an inner member through the patient's vasculature to reach the intracranial occlusion, the inner member having a proximal section and a distal tip region having a tapered section, the inner member having an axis passing centrally through the proximal section and through the distal tip region, wherein the proximal section, proximal to the distal tip region has a cylindrical surface having an outer diameter greater than a diameter of the distal tip region, wherein the proximal section is configured to advance the inner member through the patient's vasculature, and wherein the distal tip region having the tapered section has a size and a flexibility configured to reach the intracranial occlusion, wherein the proximal section and the distal tip region have a passage therethrough configured for passage and relative movement of a wire, and wherein the inner member is operatively connected to a distal access catheter having an inner diameter of 0.070″-0.095″ and having a distal inner diameter substantially corresponding to the outer diameter of the cylindrical surface and wherein the distal access catheter is movable axially relative to the cylindrical surface; maintaining the tapered section of the distal tip region at least partially outside of a distal end of the distal access catheter while the distal access catheter is advanced through at least a curved portion of the patient's vasculature and while causing axial movements of the inner member relative to the distal access catheter, the distal inner diameter of the distal access catheter and the outer diameter of the cylindrical surface being sized and having a length to prevent separation between the inner member and a leading edge of the distal access catheter; and manipulating the inner member and distal access catheter through the patient's vasculature to a terminal portion of an internal carotid artery using axial movements of the inner member relative to the distal access catheter to advance the distal access catheter through regions of the patient's vasculature having a high tortuosity and without causing separation of the cylindrical surface from the distal inner diameter of the distal access catheter.
13 . The method of claim 12 , wherein the inner member prevents the leading edge of the distal access catheter from catching on a side-branch within the curved portion.
14 . The method of claim 13 , wherein the side-branch is an ophthalmic artery.
15 . The method of claim 12 , further comprising advancing the inner member and the distal access catheter through the curved portion.
16 . The method of claim 12 , further comprising removing the inner member from the distal access catheter; and removing occlusive material while applying negative pressure to a lumen of the distal access catheter to capture occlusive material at, within, or through the distal end of the distal access catheter.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation of co-pending U.S. patent application Ser. No. 17/089,495 filed Nov. 4, 2020, which is a continuation of U.S. patent application Ser. No. 16/925,708, filed Jul. 10, 2020, now U.S. Pat. No. 11,871,944, which is a continuation of U.S. patent application Ser. No. 16/796,139, filed Feb. 20, 2020, now U.S. Pat. No. 10,743,893, which is a continuation of U.S. patent application Ser. No. 16/117,753, filed Aug. 30, 2018, now U.S. Pat. No. 10,646,239, which is a continuation of U.S. patent application Ser. No. 13/566,451, filed Aug. 3, 2012, now U.S. Pat. No. 10,327,790, which claims priority of the following U.S. Provisional Patent Applications: (1) U.S. Provisional Patent Application Ser. No. 61/515,736, filed on Aug. 5, 2011; (2) U.S. Provisional Patent Application Ser. No. 61/543,019, filed on Oct. 4, 2011; (3) U.S. Provisional Patent Application Ser. No. 61/547,597, filed on Oct. 14, 2011; (4) U.S. Provisional Patent Application Ser. No. 61/579,581, filed on Dec. 22, 2011. The disclosures of the patent applications are hereby incorporated by reference in their entirety. BACKGROUND The present disclosure relates generally to medical methods and devices for the treatment of acute ischemic stroke. More particularly, the present disclosure relates to methods and systems for transcervical access of the cerebral arterial vasculature and treatment of cerebral occlusions. Acute ischemic stroke is the sudden blockage of adequate blood flow to a section of the brain, usually caused by thrombus or other emboli lodging or forming in one of the blood vessels supplying the brain. If this blockage is not quickly resolved, the ischemia may lead to permanent neurologic deficit or death. The timeframe for effective treatment of stroke is within 3 hours for intravenous (IV) thrombolytic therapy and 6 hours for site-directed intra-arterial thrombolytic therapy or interventional recanalization of a blocked cerebral artery. Reperfusing the ischemic brain after this time period has no overall benefit to the patient, and may in fact cause harm due to the increased risk of intracranial hemorrhage from fibrinolytic use. Even within this time period, there is strong evidence that the shorter the time period between onset of symptoms and treatment, the better the results. Unfortunately, the ability to recognize symptoms, deliver patients to stroke treatment sites, and finally to treat these patients within this timeframe is rare. Despite treatment advances, stroke remains the third leading cause of death in the United States. Endovascular treatment of acute stroke is comprised of either the intra-arterial administration of thrombolytic drugs such as recombinant tissue plasminogen activator (rtPA), or mechanical removal of the blockage, or often a combination of the two. As mentioned above, these interventional treatments must occur within hours of the onset of symptoms. Both intra-arterial (IA) thrombolytic therapy and interventional thrombectomy involve accessing the blocked cerebral artery. Like IV thrombolytic therapy, IA thrombolytic therapy has the limitation in that it may take several hours of infusion to effectively dissolve the clot. Mechanical therapies have involved capturing and removing the clot, dissolving the clot, disrupting and suctioning the clot, and/or creating a flow channel through the clot. One of the first mechanical devices developed for stroke treatment is the MERCI Retriever System (Concentric Medical, Redwood City, CA). A balloon-tipped guide catheter is used to access the internal carotid artery (ICA) from the femoral artery. A microcatheter is placed through the guide catheter and used to deliver the coil-tipped retriever across the clot and is then pulled back to deploy the retriever around the clot. The microcatheter and retriever are then pulled back, with the goal of pulling the clot, into the balloon guide catheter while the balloon is inflated and a syringe is connected to the balloon guide catheter to aspirate the guide catheter during clot retrieval. This device has had initially positive results as compared to thrombolytic therapy alone. Other thrombectomy devices utilize expandable cages, baskets, or snares to capture and retrieve clot. A series of devices using active laser or ultrasound energy to break up the clot have also been utilized. Other active energy devices have been used in conjunction with intra-arterial thrombolytic infusion to accelerate the dissolution of the thrombus. Many of these devices are used in conjunction with aspiration to aid in the removal of the clot and reduce the risk of emboli. Frank suctioning of the clot has also been used with single-lumen catheters and syringes or aspiration pumps, with or without adjunct disruption of the clot. Devices which apply powered fluid vortices in combination with suction have been utilized to improve the efficacy of this method of thrombectomy. Finally, balloons