CA3095959A1

CA3095959A1 - Ischemic stroke thrombus radial system, processes, and products thereby

Info

Publication number: CA3095959A1
Application number: CA3095959A
Authority: CA
Inventors: Jake Le; David Ferrera
Original assignee: Balt Usa
Current assignee: Balt Usa
Priority date: 2015-10-26
Filing date: 2015-10-26
Publication date: 2017-05-04
Also published as: CA2979816C; WO2017074290A1; CA2979816A1

Abstract

ABSTRACT
The present invention relates to novel enhanced ischemic stroke thrombus aspiration systems, processes, and products. More specifically, the present invention is directed to a large bore aspiration catheter configured for the removal and/or destruction of an occlusion within a vessel, particularly for the removal of thrombus material from within a cerebral artery so as to restore blood flow therethrough and minimize damage to affected brain tissue.
Date Recue/Date Received 2020-10-09

Description

ISCHEMIC STROKE THROMBUS RADIAL SYSTEM, PROCESSES, AND PRODUCTS THEREBY
BACKGROUND OF THE INVENTION
[0001] Current statistics have stroke as the third leading cause of death, globally. A
stroke is-the loss of brain function due to a disturbance in the blood supply to a part of the brain, thereby depriving brain tissue of necessary oxygen. This disturbance in the blood supply is due to either ischemia (lack of blood flow) or hemorrhage.
Ischemia is caused by either blockage of a blood vessel via thrombosis or arterial embolism, or by cerebral hypoperfusion. As a result, the affected area of the brain cannot function normally, which might result in an inability to move one or more limbs on one side of the body, failure to understand or formulate speech, or a vision impairment of one side of the visual field.
[00021 A stroke is a medical emergency and can cause permanent neurological damage Or death. As such, prompt treatment is crucial and early action can minimize brain damage and potential complications. In the United States, for example, more than 1/4 of stroke victims do not survive. Current thought places the number of treatable strokes from at least about 10 - 15 percent, with less than 7 percent able to be transported to stroke treatment centers in sufficient time to allow for treatment.
[00031 Among the flurries of treatments currently being proposed, "stentrievers"
have emerged as a standard of care for large vessel occlusions, while thrombolytics and recombinant tissue plasminogen activator (rtVA) tnerapies nave not gained in popularity concomitantly. A stentriever is a long, thin, self-expanding mesh tube that is attached to a wire. The device is placed inside a catheter, positioned (via the catheter) within a patient's vasculature and advanced to the blood clot, upon which the stentriever is released from the catheter and the mesh tube expands. As the stentriever expands, it may be used to push a clot against the wall of the blood vessel to allow blood to flow more freely and may further be maneuvered to grab the clot for removal from the vessel. The delivery of stentrievers, along with endovascular flow restoration techniques, are currently leading trends in ischemic stroke treatment.
However, reimbursement issues are prominent and material with respect to these approaches.
Date Recue/Date Received 2020-10-09

2 10004] Flow restoration treatments, however, continue to evolve as more and more patients present with ischemic stroke, and' the U.S. market is now showing a dramatic shift in clinical focus. The new philosophy has been styled ADAPT, or A Direct Aspiration First Pass Technique. Details of how this works and the improvements offered for consideration by the instant teachings are offered for consideration below.
[0005] As is the case with most medical device trends, the first to market with products to address issues presented in current stroke treatments include as many challenges as solutions. For example, the 5MAX ACE extraction device for clot removal, currently offered by Penumbra, Inc. (Alameda, CA), provides direct aspiration for treatment of strokes, along with stentrievers, and Aspiration & Separator devices in kits made for clinicians. However, attending cases and being customer focused has now offered the new and improved model to the market, and shall modernize the standard of care yet again, as disclosed herein.
SUMMARY AND OBJECTS OF THE INVENTIONS
[00061 The present invention relates to novel enhanced ischemic stroke thrombus aspiration systems, processes, and products. More specifically, the present invention is directed to a large bore aspiration catheter configured for the removal of an occlusion within a vessel, particularly for the removal of thrombus material from within a cerebral artery so as to restore blood flow therethrough and minimize damage to affected brain tissue.
[00071 The large bore catheter of the present invention is designed to address the challenges that clinicians face with current approaches to arterial ischemic stroke (AIS) treatment. For example, the catheter of the present invention includes an elongate tubular body having a proximal section having an open proximal end having a first inner diameter, a distal section having an open distal end having a second inner diameter less than the first inner diameter of the proximal end, and an aspiration lumen extending from the proximal end to the distal end. In one embodiment, the proximal end has an inner diameter of approximately 0.054 inches and the distal end has an inner diameter of approximately 0.062 inches.
Date Recue/Date Received 2020-10-09

3 [0008] The catheter further includes a helical coil positioned along a length of the tubular body and in contact with a tubular wall of the tubular body. The helical coil is configured to provide sufficient support and flexibility during catheter movement within the cerebral artery and further provide support during removal of the thrombus material from within the artery. Furthermore, the distal end has a distal tip comprised of a substantially flexible biocompatible polymer material and configured to make contact with and engage thrombus material within the cerebral artery. Upon providing a vacuum to the open proximal end of the catheter, the distal tip is configured to provide a suction force to the thrombus material, so as to aspirate and collect the thrombus material within.
[0009] The catheter of the present invention enables system navigation through a patient's vasculature, particularly tortuous vasculature that typically causes issues when a clinician attempts intravascular access for treatment. Furthermore, the large bore size of the catheter facilitates delivery of many tools used for treatment of stroke to the middle cerebral artery (MCA) region in one easy step and further reduces catheter exchanges. Additionally, the larger bore size of the catheter allows for the largest in class aspiration catheter to be reproducibly delivered to the middle cerebral artery territory in conjunction with any stentriever. Accordingly, the present invention provides a novel means of treating ischemic stroke while overcoming the drawbacks of current procedures. Furthermore, in the event that direct aspiration of a thrombus material is unsuccessful, the catheter of the present invention is configured to facilitate the delivery of other tools currently used for treatment and/or removal of thrombus material, such as a stentriever and/or a separator, as well as a microcatheter for direct infusion of thrombolytic agents such as tPA.
[0010] According to embodiments described herein, an aspiration catheter for removal of an occlusion within a vessel is provided. The catheter includes an elongate tubular body having 'a proximal section having an open proximal end, a distal section having an open distal end, an outer surface, and an inner surface defining a lumen extending between the proximal and distal ends. The catheter further includes a support assembly positioned along a length of the tubular body and in contact with a Date Recue/Date Received 2020-10-09

4 tubular wall of the tubular body. The support assembly is configured to provide sufficient support and flexibility during catheter movement within a vessel and further provide support during removal or destruction of an occlusive material from within the = vessel.
[10011] The distal end of the catheter has a distal tip configured to make contact with and engage an occlusive material within the vessel. The distal end is configured to communicate a vacuum along the length of the lumen from the proximal end to the distal tip so as to provide a suction force to the occlusive material for removal from within the vessel, thereby restoring blood flow through the vessel.
[0014 In some embodiments, the proximal end has an outer diameter within the range of from 0.070 in to 0.084 in. In some embodiments, the proximal end has an outer diameter of 0.074 in. In some embodiments, the proximal end has an inner diameter within the range of from 0.060 in to 0.072 in. In some embodiments, the proximal end has an inner diameter of 0.064 in. In some embodiments, the distal end has an outer diameter within the range of from 0.065 in to 0.077 in. In some embodiments, the distal end has an outer diameter of 0.070 in. In some embodiments, the distal end has an inner diameter within the range of from 0.060 in to 0.072 in. In some embodiments, the distal end has an inner diameter of 0.062 in. In some embodiments, the elongate tubular body ot the catheter has a length within the range of from 90 cm to 150 cm.
[0013] In some embodiments, the support assembly is configured to support the lumen of the catheter against collapse upon application of the suction force thereto. In some embodiments, the support assembly comprises a helical coil disposed along a length of the catheter body. The helical spring may be constructed of a Nitinol alloy.
[0014] In some embodiments, distal tip comprises a substantially flexible biocompatible polymer material. The distal tip is configured to aspirate and collect between 30 percent and 100 percent of the occlusive material. In some embodiments, the distal tip is configured to aspirate and collect between 50 percent and 80 percent of the occlusive material. In some embodiments, the aspirated occlusive material is collected within at least the distal section of the catheter body. In some embodiments, Date Recue/Date Received 2020-10-09

5 the occlusive material is a thrombus, an embolus, or a combination thereof and the vessel is a cerebral artery.
[0015]
According to another embodiment described herein, an aspiration catheter for removal or destruction of a thrombus material within a cerebral artery is provided.
The aspiration catheter includes an elongate tubular body having a proximal section having an open proximal end having a first inner diameter, a distal section having an open distal end having a second inner diameter less than the first inner diameter of the proximal end, and an aspiration lumen extending from the proximal end to the distal end. The catheter further includes a helical coil embedded within a tubular wall of a portion of the distal section. The helical coil is configured provide sufficient support and flexibility during catheter movement within the cranial artery and further provide support during removal or destruction of the thrombus material from within the artery.
[0016] The distal end of the catheter has a distal tip comprised of a substantially flexible biocompatible polymer material and configured to make contact with and engage thrombus material within the cranial artery. The distal end is configured to communicate a vacuum along the length of the lumen from the proximal end to the distal tip so as to provide a suction force to the thrombus material. The distal tip is configured to aspirate and collect between 30 percent and 100 percent of the thrombus material.
([00171 While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.
Date Recue/Date Received 2020-10-09

6 [0018) Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.
[0019]
100201 The indefinite articles "a" and "an," as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one."
[0021] The phrase "and/or," as used herein in the specification and in the claims, should be understood to mean 'either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases.. Other elements may optionally be present other than the elements specifically identified by the "and/or clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.
[0022] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
Date Recue/Date Received 2020-10-09

7 [0023] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
_ [0024] FIG. 1 illustrates an ischemic stroke within a cerebral artery of human.
[0025] FIG.
2 is a side view of an aspiration catheter consistent with the present disclosure.
[0026] FIG.
3 is an enlarged cross sectional view of the proximal and distal ends of the catheter of FIG. 2.
[0027] FIG.
4 is a perspective view, partly in section, of a portion of the aspiration catheter of FIG. 2.
[00281 FIG.
5 illustrates the direct aspiration first pass technique of removing thrombus material from within a cerebral artery using a catheter consistent with the present disclosure.
[0029] FIG.
6A is an angiogram of a patient's artery illustrating occluded vasculature prior to a direct aspiration first pass technique (ADAPT) using a catheter consistent with the present disclosure.
[0030] FIG.
6B is an angiogram of a patient's artery post ADAPT procedure illustrating the restoration of blood flow into the vasculature.
[00311 FIG.
7 illustrates thrombus material aspirated and removed from the artery via a catheter consistent with the present disclosure.
1[00321 FIG.
8A is an angiogram of a patient's artery illustrating occluded vasculature prior to ADAPT procedure using a catheter consistent with the present disclosure.
Date Recue/Date Received 2020-10-09

8 [0033]; FIG. 8B is an angiogram of a patient's artery post ADAPT procedure illustrating the restoration of blood flow into the vasculature.
[0034] FIG. 9 illustrates thrombus material aspirated and removed from the artery via a catheter consistent with the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
400351 By way of overview, the present invention is generally directed to novel enhanced ischemic stroke thrombus aspiration systems, processes, and products.

More specifically, the present invention is .directed to a large bore aspiration catheter configured for the removal or destruction of an occlusion within a vessel, particularly for the removal or destruction of thrombus material from within a cerebral artery so as to restore blood flow therethrough and minimize damage to affected brain tissue.
10036] The large bore catheter of the present invention is designed to address the challenges that clinicians face with current approaches to arterial ischemic stroke (AIS) treatment. For example, the catheter of the present invention includes an elongate tubular body having a proximal section having an open proximal end having a first inner diameter, a distal section having an open distal end having a second inner diameter less than the first inner diameter of the proximal end, and an aspiration lumen extending from the proximal end to the distal end. In one embodiment, the proximal end has an inner diameter of approximately 0.064 inches and the distal end has an inner diameter of approximately 0.062 inches.
[00371 The catheter further includes a helical coil positioned along a length of the tubular body and in contact with a tubular wall of the tubular body. The helical coil is configured to provide sufficient support and flexibility during catheter movement within the cerebral artery and further provide support during removal or destruction of the thrombus material from within the artery. Furthermore, the distal end has a distal tip comprised of a substantially flexible biocompatible polymer material and configured to make contact with and engage thrombus material within the cerebral artery.
Upon providing a vacuum to the open proximal end of the catheter, the distal tip is configured Date Recue/Date Received 2020-10-09

9 to provide a suction force to the thrombus material, so as to aspirate and collect the thrombus material within.
10038] The catheter of the present invention enables system navigation through a patient's vasculature, particularly tortuous vasculature that typically causes issues when a clinician attempts intravascular access for treatment. Furthermore, the large bore size of the catheter facilitates delivery of many tools used for treatment of stroke to the middle cerebral artery (MCA) region in one easy step and further reduces catheter exchanges. Additionally, the larger bore size of the catheter allows for the largest in class aspiration catheter to be reproducibly delivered to the middle cerebral artery territory in conjunction with any stentriever or microcatheter for direct administration of thrombolytic agents. Accordingly, the present invention provides a novel means of treating ischemic stroke while overcoming the drawbacks of current procedures.

Furthermore, in the event that direct aspiration of a thrombus material is unsuccessful, the catheter of the present invention is configured to facilitate the delivery of other tools currently used for treatment and/or removal and/or destruction of thrombus material, such as a stentriever and/or a separator and/or 8F balloon and/or microcatheter for direct administration of thrombolytic agents.
110039] FIG. 1 provides a general depiction of an ischemic stroke caused as a result of an obstruction within a blood vessel supplying blood to the brain. An ischemic stroke occurs when an artery to the brain is blocked. For example, an obstruction may occur in an artery within the brain itself (e.g., cerebral artery 12) and/or an obstruction occurs in an artery supplying blood to the brain (e.g., vertebral artery 10). The brain depends on its arteries to bring fresh blood from the heart and lungs. The blood carries oxygen and nutrients to the brain, and takes away carbon dioxide and cellular waste.
If an artery is blocked, the brain cells (neurons) cannot make enough energy and will eventually stop working. If the artery remains blocked for more than a few minutes, the brain cells may die.
[0040] lschemic stroke can be caused by several different kinds of diseases. The most common problem is narrowing of the arteries in the neck or head. This is most often caused by atherosclerosis, or gradual cholesterol deposition. If the arteries Date Recue/Date Received 2020-10-09

10 become too narrow, blood cells may collect and form blood clots. These blood clots can block the artery where they are formed (thrombosis), or can dislodge and become trapped in arteries closer to the brain (embolism). Another cause of stroke is blood clots in the heart, which can occur as a result of irregular heartbeat (for example, atrial fibrillation), heart attack, or abnormalities of the heart valves. While these are the most common causes of ischemic stroke, there are many other possible causes.
Examples include, but are not limited to, drug use, traumatic injury to the blood vessels of the neck, or blood clotting disorders.
1[0041] A thrombotic stroke occurs when diseased or damaged cerebral arteries become blocked by the formation of a blood clot within the brain. Clinically referred to as cerebral thrombosis or cerebral infarction, this type of event is responsible for almost 50 percent of all strokes. Cerebral thrombosis can also be divided into an additional two categories that correlate to the location of the blockage within the brain:
large-vessel thrombosis and small-vessel thrombosis. Large-vessel thrombosis is the term used when the blockage is in one of the brain's larger blood-supplying arteries such as the carotid or middle cerebral, while small-vessel thrombosis involves one (or more) of the brain's smaller, yet deeper, penetrating arteries. This latter type of stroke is also called a lacunar stroke.
[0042] As shown in FIG. 1, a blood clot 14 has formed within the middle cerebral artery 12, thereby resulting in an obstruction of blood flow to an affected area 16 of the brain. The blood clot 14 may generally be formed by a thrombus or an embolus within the artery lumen. A thrombus is a solid mass of platelets and/or fibrin (and other components of blood) that forms locally in a vessel. Thrombi form when the clotting mechanism is activated. Thrombus formation also occurs in places where blood flow is sluggish, enabling clotting factors to accumulate and giving platelets more opportunity to stick together. Disorders of blood cells (for instance sickle cell disease) or blood proteins can increase the chance of thrombus formation and therefore contribute to the risk of ischemic stroke.
Date Recue/Date Received 2020-10-09

11 [0043] An embolus is most often a piece of a thrombus that has broken free and is carried toward the brain by the bloodstream. The term thromboembolus may be used, as most emboli arise from thrombi. However, bits of plaque, fat, air bubbles, and other material also qualify as emboli. Presumably an embolus floats along with the flowing blood until it encounters a narrowing in an artery through which it cannot pass. When the embolus gets stuck, it blocks the artery. This reduces blood flow to downstream tissues and causes them to become ischemic.
[0044] This sudden loss of blood circulation to an area of the brain 16 may result in a corresponding loss of neurologic function. Accordingly, it is very important to diagnose and treat blocked arteries as soon as possible to prevent permanent damage and even death.
_ [0045] Emergent brain imaging is essential for confirming the diagnosis of ischemic stroke. For example, non-contrast computed tomography (CT) scanning is the most commonly used form of neuroimaging in the acute evaluation of patients with apparent acute stroke. Other neuroimaging techniques include CT angiography and CT
perfusion scanning, magnetic resonance imaging (MRI), carotid duplex scanning, and digital subtraction angiography.
[0046] According to certain aspects, the present invention is generally directed to a novel enhanced ischemic stroke aspiration catheter configured for the removal of a blockage within a vessel, particularly for the removal of thrombus material from within a cerebral artery so as to restore blood flow therethrough and minimize damage to affected brain tissue.
[6647] FIG. 2 is a side view of an aspiration catheter 100 consistent with the present disclosure. As shown, the aspiration catheter 100 includes an elongate tubular body 102 having a proximal section 104 having an open proximal end 106 and a distal section 108 having an open distal end 110. The distal end 110 includes a distal tip 112 configured to make contact with and engage an occlusive material within a vessel requiring treatment. For example, as described in greater detail herein, the catheter 100 is configured to be introduced within and navigate a patient's vasculature until the Date Recue/Date Received 2020-10-09

12 distal tip 112 reaches a target site (e.g., blockage within artery). The distal tip 112 is then configured to make contact with and engage the blockage for subsequent removal from the artery so as to restore blood flow through the artery.
[00481 FIG. 3 is an enlarged cross sectional view of the proximal and distal ends 106, 110 of the catheter 100. As shown, a lumen 114 continuously extends from the proximal end 106 to the distal end 110 of the catheter body 102 and is configured to provide a suction force from a vacuum source coupled to the proximal end 106.
As shown, the catheter 100 further includes a support assembly 116 positioned along a length of the tubular body 102 and in contact with a tubular wall 118 of the tubular body 102. The support assembly 116 is configured to provide sufficient support and flexibility during catheter movement within a vessel and further provide support during removal of an occlusive material from within the vessel. For example, upon initiation of a vacuum source, the distal end 112 is configured to aspirate material in which it is in contact with.
The support assembly 116 is configured support the lumen 114 of the catheter against collapse upon application of the suction force.
[0049] As shown, in FIG. 4, for example, the support assembly 116 may include a helical coil disposed along a length of the catheter body 102. In some embodiments, the helical coil may be embedded within the tubular wall 118 of the catheter body 102, such that it is integral with the catheter 100. The helical coil may be constructed of a nitinol alloy, for example, so as to provide strength with sufficient flexibility to allow navigation of tortuous and fragile vasculature, particularly cerebral vasculature, such as the middle cerebral artery. In some embodiments, the helical coil may be provided along the entire length of the catheter body 102. In other embodiments, the helical coil may be limited to predefined portions.
(0050] Referring to FIG. 3, the aspiration catheter 100 may have a length within the range of from at least about 115 cm to approximately 135 cm. However, it should be noted that the length may vary depending on the particular site being accessed. As shown in FIG. 3, the proximal end 106 has an outer diameter D1 and an inner diameter D2 that are both generally greater than an outer diameter D3 and inner diameter D4 of the distal end 110, respectively. In some embodiments, the outer diameter D1 of the Date Recue/Date Received 2020-10-09

13 proximal end 106 is within the range of from 0.070 inches to 0.080 inches (in). In one embodiment, the proximal end 106 has an outer diameter D1 of 0.074 in. In some embodiments, the outer diameter D3 of the distal end 110 is within the range of from 0.065 in to 0.075 in. In one embodiment, the distal end 110 has an outer diameter D3 of 0.070 in. In some embodiments, the inner diameter D2 of the proximal end 106 is within the range of from 0.060 in to 0.070 in. In one embodiment, the proximal end 106 has an inner diameter D2 of 0.064 in. In some embodiments, the inner diameter D4 of the distal end 110 is within the range of from 0.060 in to 0.075 in. In one embodiment, the distal end 110 has an inner diameter D4 of 0.062 in. Accordingly, in one embodiment, the proximal end 106 may have an outer diameter D1 of 0.074 in and an inner diameter D2 of 0.064 in, while the distal end 110 may have an outer diameter D3 of 0.070 in and an inner diameter D4 of 0.062 in.
100511 The aspiration catheter 100 may have variable stiffness throughout its length. For example, in one embodiment, the proximal and distal sections 104, may have different levels of stiffness. In one embodiment, the support assembly 116 may only extend along a predetermined length of the catheter 102, wherein it may extend the entire length of the proximal section 104 and only partially extend into the distal section 108, thereby resulting in a more flexible distal end 110 and distal tip 112.
In other embodiments, the proximal section 104 may have a greater level of stiffness than the distal section 108 due to differences in material construction. For example, in some embodiments, the proximal and distal sections 104, 108 may be constructed of the same material, but may have different thickness thereby resulting in different levels of stiffness. For example, the proximal section 104 may have thicker wall while the distal section 108 has a thinner wall, thereby resulting in the proximal section 104 being more rigid and the distal section 108 being more flexible, [00521 In other embodiments, the proximal and distal sections 104, 108 may be constructed of different materials that result in different levels of stiffness. For example, the proximal section 104 may be constructed of a relatively rigid material including, but not limited to, various metals (stainless steel, Nitinol, or alloys thereof) and polymers (rigid polyamide, polyurethane, or copolymers thereof). The distal section 108 may be constructed of a relatively durable and flexible material including, but not limited to, a Date Recue/Date Received 2020-10-09

14 non-reinforced polymer extrusion from materials such as polyamide, polyurethane, or co-polymer derivatives thereof. In any case, at least one portion of the catheter body 102 is constructed from a biocompatible material.
[0053] FIG. 5 illustrates A Direct Aspiration first Pass Technique (ADAPT) using the aspiration catheter 100 of the present invention. Under the ADAPT procedure, the catheter 100 is first introduced into the patient's vasculature. For example, at the start of the procedure, a small incision may be made at the patient's femoral artery, or other commonly used access site. Using angiography, a clinician can observe the patient's vascular system on a video screen while navigating the vasculature and advancing the catheter through blood vessels 120 and .further positioning the distal tip 112 of the catheter into the cerebral artery 12 of the patient's brain so as to engage the blockage 122. Once the distal tip 112 is positioned next to the blockage (e.g., thrombus blood clot 122), the clinician can then control a vacuum source coupled to the catheter 100, thereby providing a suction source to the distal tip 112. Upon engaging and making contact with the blood clot 122, the distal tip 112 is configured to aspirate and collect the blot clot 122, as indicated by arrow 124, within the lumen of catheter 100 for subsequent removal from the artery 12. This immediately allows blood to flow more freely within the artery 12.
[00541 The aspiration catheter 100 of the present disclosure is configured to aspirate and collect between 30 percent and 100 percent of the blood clot 122, at least on a first pass prior to removal of the catheter 100. In some embodiments, the catheter 100 is configured to aspirate and collect between 50 percent and 80 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 55 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 60 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 65 percent of the blood clot 122: In other embodiments, the catheter 100 is configured to aspirate and collect at least 70 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 75 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 80 Date Recue/Date Received 2020-10-09

15 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 85 percent of the blood clot 122. In other embodiments, the catheter 100 is configured to aspirate and collect at least 90 percent of the blood clot 122. In other embodiments, the 'catheter 100 is configured to aspirate and.
collect at least 95 percent of the blood clot 122.
I[0055] A benefit of a large bore aspiration catheter consistent with the present disclosure is that the large bore size of the catheter facilitates delivery of many tools used for treatment of stroke to the middle cerebral artery (MCA) region in one easy step and further reduces catheter exchanges. Additionally, the larger bore size of the catheter allows for the largest in class aspiration catheter to be reproducibly delivered to the middle cerebral artery territory in conjunction with any stentriever.
Accordingly, the present invention provides a novel means of treating ischemic stroke while overcoming the drawbacks of current procedures. Furthermore, in the event that direct aspiration of a thrombus material is unsuccessful the catheter of the present invention is configured to facilitate the delivery of other tools currently used for treatment and/or removal and/or destruction of thrombus material, such as a stentriever and/or a separator and/or microcatheter for direct administration of thrombolytic agents. Accordingly, if aspiration procedure under ADAPT is unsuccessful (e.g., does not restore blood flow to a desired level) other procedures may be used utilizing the catheter 100, including the retrieval and/or destruction of the blood clot 122 via a stentriever.
[0056] FIG. 6A is an angiogram of a patient's artery illustrating occluded vasculature 200 prior to a direct aspiration first pass technique (ADAPT) using a catheter consistent with the present disclosure. The vasculature 200 may include an artery, such as a cerebral artery, for example. FIG. 6B is an angiogram of a patient's vasculature 200 post an ADAPT procedure illustrating the restoration of blood flow into the vasculature, as indicated by arrows 202a and 202b. The angiogram of FIG.

illustrates the restoration of blood flow upon removal of a blood clot, upon which such restoration was obtained just 45 minutes after initial presentation of the blocked artery 200. As based on the Thrombolysis in Cerebral Infarction (TICI) classification scale, the ADAPT procedure resulted in restoration of blood flow having TICI 3, which correlates Date Recue/Date Received 2020-10-09

16 to complete perfusion of the artery, wherein antegrade flow into the bed distal to me obstruction occurs as promptly as into the obstruction and clearance of contrast material from the involved bed is as rapid as that from an uninvolved other bed of the same vessel or the opposite cerebral artery.
100571 FIG. 7 depicts aspirated thrombus material (blood clot 204) collected and removed from the artery 200 via a catheter 100 consistent with the present disclosure.
As shown, the thrombus material 204 is collected within the lumen of the catheter 100, generally within the lumen of the distal section 108 via the distal tip 112. A
clinician may then remove the catheter 100 from the patient and further remove the plug of thrombus material 204 for further testing and pathology if desired.
[0058] FIG. 8A is another angiogram of a patient's artery illustrating occluded vasculature 300 prior to a direct aspiration first pass technique (ADAPT) using a catheter consistent with the present disclosure. The vasculature 300 may include an artery, such as a cerebral artery, for example. FIG. 86 is an angiogram of a patient's vasculature 300 post an ADAPT procedure illustrating the restoration of blood flow into the vasculature, as indicated by arrows 302a and 302b. The angiogram of FIG.

illustrates the restoration of blood flow upon removal of a blood clot. Prior to treatment, the artery 300 had a primary arterial occlusive lesion (AOL) score of 0, which is associated with no recanalization of the primary occlusive lesion and no perfusion.
After treatment, particularly at least four ADAPT retrievals, the artery 300 had an AOL
recanalization score of 3, which is associated with complete recanalization of the primary occlusion with any distal flow, including full perfusion with filling of all distal branches, as based on the AOL classification.
[00591 FIG. 9 depicts multiple plugs of aspirated thrombus material (blood clots 304) collected and removed from the artery 300 via a catheter 100 consistent with the present disclosure. As shown, the thrombus material 304 is collected within the lumen of the catheter 100, generally within the lumen of the distal section 108 via the distal tip 112. A clinician may then remove the catheter 100 from the patient and further remove and/or destroy the plug of thrombus material 304 for further testing and pathology if desired.
Date Recue/Date Received 2020-10-09

17 [0060] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term 'about.' Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention.
At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
100611 The terms "a," ''an," "the" and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a. shorthand method of referring individually to each separate value falling within the range.
All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[00621 Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other Date Recue/Date Received 2020-10-09

18 elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability.
When any such inclusion or deletion occurs, the specification is 'deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
[0063]' Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
[00641 Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term "consisting of"
excludes any element,. step, or ingredient not specified in the claims. The transition term "consisting essentially of' limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s).

Embodiments of the invention so claimed are inherently or expressly described and enabled herein.
[00651 100661 In closing,' it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention.
Other modifications that may be employed are within the scope of the invention.
Thus, by way of example, but not of limitation, alternative configurations of-the present invention may-be utilized in accordance with the teachings herein. Accordingly, the present invention Is not limited to that precisely as shown and described.
=
Date Recue/Date Received 2020-10-09

Claims

WHAT IS CLAIMED IS:

1. A radial catheter for removal and/or destruction of an occlusion within a vessel, the catheter comprising:
an elongate tubular body having a proximal section having an open proximal end, a distal section having an open distal end, an outer surface, and an inner surface defining a lumen extending between the proximal and distal ends; and a support assembly positioned along a length of the tubular body and in contact with a tubular wall of the tubular body, the support assembly comprising a helical coil that is configured to provide sufficient support and flexibility during catheter movement within a vessel and further provide support during removal and/or destruction of an occlusive material from within the vessel;
wherein the distal end has a distal tip configured to make contact with and engage an occlusive material within the vessel, the distal end configured to communicate a vacuum along the length of the lumen from the proximal end to the distal tip so as to provide a suction force to the occlusive material for removal from and/or destruction within the vessel, thereby restoring blood flow through the vessel.

2. The radial catheter of claim 1, wherein the proximal end has an outer diameter within the range of from 0.086 in to 0.114 in.

3. The radial catheter of claim 1, wherein the proximal end has an inner diameter within the range of from 0.072 in to 0.100 in.
Date Recue/Date Received 2020-10-09

4. The radial catheter of claim 1, wherein the distal end has an outer diameter within the range of from 0.086 in to 0.114 in.

5. The radial catheter of claim 1, wherein the distal end has an inner diameter within the range of from 0.060 in to 0.072 in.

6. The radial catheter of claim 1, wherein the elongate tubular body of the catheter has a length within the range of from at least about 92 cm to approximately 177 cm or more.

7. The radial catheter of claim 1, wherein the support assembly comprises a helical coil or braid disposed about a length of the catheter body.
Date Recue/Date Received 2020-10-09