Aspiration catheter, system and method thereof

Abstract

The present invention is entitled "Aspiration Catheter, System, and Methods Thereof." The present invention discloses a catheter comprising a distal tip section disposed on or near a distal end of the catheter, the distal tip section invertible about a transition between a catheter body and the distal tip section between a first configuration and a second configuration. Inverting the distal tip section about the transition from the first configuration to the second configuration causes the distal tip section to comprise a deployable tip having an open funnel-like distal mouth, the open funnel-like distal mouth having a diameter greater than a diameter of the transition.

Description

[0001] Cross Reference to Related Applications

[0002] This patent application claims priority to U.S. Provisional Patent Application No. 62 / 941,414, filed November 27, 2019, the contents of which are incorporated by reference herein in their entirety as if set forth in full. TECHNICAL FIELD

[0003] The present disclosure relates generally to devices and methods for removing acute emboli from blood vessels during endovascular medical treatment. More particularly, the present disclosure relates to aspiration catheters. BACKGROUND

[0004] Clot retrieval catheters and devices are frequently used in mechanical thrombectomy for endovascular intervention in cases where patients suffer from conditions such as acute ischemic stroke (AIS), myocardial infarction (MI), and pulmonary embolism (PE). Accessing a neurovascular bed using conventional techniques is particularly challenging because the target vessel is small in diameter, distal relative to the site of insertion, and highly tortuous. Traditional devices are often too large in profile, lack the deliverability and flexibility required to navigate tortuous vessels, or are not effective at removing clots when delivered to the target site.

[0005] Clots themselves can complicate the procedure by assuming a variety of complex morphologies and consistencies, ranging from simple tubular structures that assume the shape of the vessel to long, chain-like arrangements that can span multiple vessels at once. The age of the clot can also affect its compliance, with older clots tending to be less compressible than fresh clots. Experience has also shown that the mechanical properties of clots can be affected in significant ways depending on the nature of the interaction with the clot extraction device. Additionally, several mechanisms play a role in the strong adhesion of clots to the vessel wall. Disrupting these adhesions without damaging the delicate neurovascular structures is a significant challenge.

[0006] Delivering an effective device to the small and highly branched cerebral arterial system remains challenging, and conventional clot retrieval catheters have a number of shortcomings. First, the diameter of the catheter itself must be small enough to avoid causing significant discomfort to the patient. The retrieval catheter must also have sufficient flexibility to navigate the vasculature and withstand high strains, while also having axial stiffness to provide smooth propulsion along the route. Once at the target site, the size of the typical object being retrieved from the body is significantly larger than the distal end of the catheter, making it more difficult to retrieve the object into the distal end. For example, firm fibrin-rich clots are often difficult to extract because they can become aggregated in the distal end of a traditional fixed-oral catheter. Additionally, this aggregation can cause the softer portions to be sheared off from the more firm regions of the clot.

[0007] Small diameters and fixed tip sizes are also less effective at suctioning blood and thrombus material needed during a guided procedure. The aspiration must be sufficiently powerful so that any fragmentation that can occur as a result of the aspiration or use of a mechanical thrombectomy device can remain stationary, whereby the debris cannot migrate and occlude the distal vessel. However, when aspirating with a fixed mouth catheter, a significant portion of the aspiration flow ultimately comes from the vessel fluid proximal to the catheter tip where there is no clot. This significantly reduces the efficiency of the aspiration, reducing the success rate of clot removal.

[0008] Any catheter design that attempts to overcome these challenges with a deployed distal tip or structure needs to have the strength to grip the clot and exert a stable radial force in the deployed state. The same structure also needs to have sufficient flexibility and elasticity to withstand the severe mechanical strains imparted when navigating the tortuous vasculature while in the collapsed state.

[0009] The present solution addresses these and other issues in the art. SUMMARY

[0010] It is an object of the present design to provide systems, devices, and methods that meet the above needs. Thus, it is desirable for an aspiration clot retrieval catheter to have a clot-facing mouth for aspiration efficiency and ease of clot retrieval, while also having a collapsed state that is low profile and flexible enough in multiple directions to be deliverable to a target site. The catheter body can also incorporate deliverability enhancements compared to existing designs to facilitate operation.

[0011] In some examples, an aspiration catheter is disclosed that includes a catheter body having a proximal end and a distal end. A distal tip segment can be disposed on or near the distal end, the distal tip segment invertible about a transition between the catheter body and the distal tip segment between a first configuration and a second configuration. Inverting the distal tip segment about the transition from the first configuration to the second configuration causes the distal tip segment to invert about the transition from the first configuration to the second configuration, the second configuration including a deployable tip having an open funnel-shaped distal mouth, the open funnel-shaped distal mouth having a diameter greater than a diameter of the transition.

[0012] In some examples, the distal tip segment includes a guide catheter within a collapsed configuration.

[0013] In some examples, the first configuration and the second configuration are part of a deployed configuration of the distal tip segment distal of a guide catheter or sheath.

[0014] In some examples, the distal tip segment includes a mushroom-shaped segment configured to invert into the second configuration and form the open funnel-shaped distal mouth.

[0015] In some embodiments, the distal end segment is shaped and configured to reduce clot shear in the first configuration.

[0016] In some examples, the distal end segment includes multiple sealing members configured to be an open funnel-shaped distal mouth portion of a second configuration, inverted from a mushroom-shaped segment in a first configuration.

[0017] In some examples, each sealing member includes a hemispherical shape in the first and second configurations, the hemispherical shape being a mirror image of the other substantially opposite to each other between the first and second configurations.

[0018] In some examples, each sealing member corresponds to a separate funnel-shaped nozzle in the second configuration.

[0019] In some examples, each sealing member corresponds to multiple sealing layers with the corresponding blood vessel wall.

[0020] In some examples, each sealing member can be inverted around the corresponding transition section.

[0021] In some examples, each sealing member is selectively spaced apart along the conduit body. In some examples, the sealing members are equidistant. In some examples, the sealing members are gradually spaced apart, either closer together or further apart. In some examples, the sealing members are aligned along a common longitudinal axis.

[0022] In some examples, the distal distal segment includes a proximal portion and a distal portion, the diameter of which is smaller than that of the proximal portion. The diameter of the proximal portion may be at least twice the diameter of the distal portion. The distal portion may have an open, atraumatic tip that is continuous with the lumen of the catheter body. The outer surface of the distal distal segment may be curved or otherwise contoured between the proximal and distal portions.

[0023] In some examples, the open funnel-shaped distal mouth can collapse during or after surgery to reduce or remove flow restriction in the blood vessel.

[0024] In some examples, methods for aspirating occlusive thrombi from a blood vessel are disclosed. This method may include at least partially translating an aspiration catheter distal to a sheath or delivery catheter, thereby moving a distal distal segment of the aspiration catheter from a collapsed configuration to a first unfolded configuration; retracting the distal distal segment, thereby causing the distal distal segment to be inverted around a transition between the distal distal segment and the catheter body to a second unfolded configuration, the second configuration including an unfoldable end having an open funnel-shaped distal nozzle with a diameter larger than the diameter of the transition.

[0025] In some examples, the method includes delivering the aspiration catheter according to the present disclosure to a location of interest in the blood vessel.

[0026] In some examples, the method includes performing aspiration through the distal tip segment to stimulate thrombus into an open funnel-like distal mouth of the distal tip segment.

[0027] In some examples, the method includes forming the distal tip segment with a mushroom segment configured to invert into a second configuration and form an open funnel-like distal mouth.

[0028] In some examples, the method includes shaping the distal tip segment to reduce clot shear in the first configuration.

[0029] In some examples, the method includes reducing clot shear in the first configuration by the distal tip segment.

[0030] In some examples, the method includes inverting a plurality of sealing members of the distal tip segment from a mushroom segment in the first configuration to the open funnel-like distal mouth in the second configuration.

[0031] In some examples, the method includes inverting each sealing member of the distal tip segment to form a corresponding funnel-like distal mouth.

[0032] In some examples, each sealing member includes a hemispherical shape in the first and second configurations that is a mirror image of the other substantially opposite each other between the first and second configurations.

[0033] In some examples, the method includes sealing a plurality of sealing layers with a corresponding blood vessel wall by each sealing layer of a respective sealing member.

[0034] In some examples, each sealing member is invertable about a respective transition.

[0035] In some examples, the method includes selectively spacing each sealing member along the catheter body.

[0036] In some examples, the method includes collapsing the open funnel-like distal mouth during a procedure to reduce or remove a flow restriction in the blood vessel.

[0037] In some examples, the method includes collapsing the open funnel-like distal mouth after a procedure to reduce or remove a flow restriction in the blood vessel.

[0038] Other aspects and features of the present disclosure will become apparent to those ordinarily skilled in the art upon review of the following detailed description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0039] The above-described and other aspects of the present disclosure are further discussed with reference to the following description in conjunction with the appended drawings, where like designations direct to like elements and features in each of the figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the present disclosure. The drawings depict one or more specific embodiments in accordance with the present disclosure in example form. It is to be understood that not all of the features will be utilized in every embodiment and that one skilled in the art will be able to conceive and combine elements from the various drawings to better meet the needs of the user.

[0040] Figure 1A is a close-up view of an exemplary catheter embodiment of the present disclosure with the distal tip section in a first configuration.

[0041] Figure 1B is a close-up view of the tip section of Figure 1A in a second configuration.

[0042] Figure 2A is a close-up perspective view of an exemplary catheter of Figures 1A-1B in a first configuration.

[0043] Figure 2B is a close-up perspective view of an exemplary catheter of Figures 1A-1B in a first configuration.

[0044] Figure 3A is a close-up perspective view of an exemplary catheter of Figures 1A-1B in a first configuration.

[0045] Figure 3B is a close-up of section A-A from Figure 3A

[0046] Figure 4A is a close-up view of an exemplary catheter embodiment of the present disclosure with the distal tip section in a first configuration.

[0047] Figure 4B is a close-up view of the tip section of Figure 4A in a second configuration.

[0048] Figure 5 is a close-up view of an exemplary catheter embodiment of the present disclosure with the distal tip section in a first configuration.

[0049] Figure 6 is a close-up view of an exemplary catheter embodiment of the present disclosure with the distal tip section in a first configuration.

[0050] Figure 7A ​is a close-up cross-sectional view of one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration.

[0051] Figure 7B is a close-up cross-sectional view of one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration.

[0052] Figure 7C is a close-up cross-sectional view of one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration.

[0053] Figure 8A is a close-up view of one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration.

[0054] Figure 8B is a close-up view of one exemplary shoulder segment of the tip segment of Figure 8A at segment B-B in a second configuration.

[0055] Figure 8C is a close-up view of one exemplary shoulder segment of the tip segment of Figure 8A at segment B-B in a second configuration.

[0056] Figure 8D is a close-up view of one exemplary shoulder segment of the tip segment of Figure 8A at segment B-B in a second configuration.

[0057] Figure 8E is a close-up view of one exemplary shoulder segment of the tip segment of Figure 8A at segment B-B in a second configuration.

[0058] Figure 9 depicts one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration being delivered to a treatment site in a blood vessel.

[0059] Figure 10 depicts one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration being delivered to a treatment site in a blood vessel.

[0060] Figure 11 depicts one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration being delivered to a treatment site in a blood vessel.

[0061] Figure 12A is a close-up view of one exemplary catheter embodiment of the present disclosure with the distal tip segment in a first configuration during a clot aspiration procedure in a blood vessel.

[0062] Figure 12B is a distal end segment of the catheter of Figure 12A

[0063] Figure 13 is a schematic view of an embodiment of one exemplary catheter of the present disclosure, wherein the distal end segment is shown moving between a first configuration and a second configuration when used with a sheath and balloon guide catheter.

[0064] Figure 14A is a close-up perspective view of an embodiment of one exemplary catheter of the present disclosure, wherein the distal end segment is in a first configuration.

[0065] Figure 14B is a close-up cross-sectional view of the exemplary catheter of Figure 14A , wherein the distal end segment is in a first configuration.

[0066] Figure 14C is a close-up cross-sectional view of an embodiment of the exemplary catheter of Figure 14A , wherein the distal end segment is in a first configuration.

[0067] Figure 15A is a close-up perspective view of an embodiment of one exemplary catheter of the present disclosure, wherein the distal end segment is in a first configuration.

[0068] Figure 15B is a rear perspective view of the exemplary catheter of Figure 15A , wherein the distal end segment is in a first configuration.

[0069] Figure 16A is a close-up perspective view of an embodiment of one exemplary catheter of the present disclosure, wherein the distal end segment is in a first configuration.

[0070] Figure 16B is a rear plan view of the catheter of Figure 16A , wherein the distal end segment is in a first configuration.

[0071] Figure 16C is a close-up cross-sectional view of the catheter of Figure 16A , wherein the distal end segment is in a first configuration.

[0072] Figure 16D is another close-up cross-sectional view of the catheter of Figure 16A , wherein the distal end segment is in a first configuration.

[0073] Figure 17A is a close-up perspective view of an embodiment of one exemplary catheter of the present disclosure, wherein the distal end segment is in a first configuration.

[0074] ​Figure 17B is Figure 17A a rear plan view of an exemplary catheter of

[0075] Figure 17C is Figure 17A a close-up cross-sectional view of an exemplary catheter of

[0076] Figure 18A is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0077] Figure 18B is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0078] Figure 19A is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0079] Figure 19B is a close-up view of an exemplary shoulder segment of the tip segment of Figure 19A at segment C-C in a first configuration.

[0080] Figure 19C is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0081] Figure 19D is a close-up view of an exemplary shoulder segment of the tip segment of Figure 19C at segment D-D in a first configuration.

[0082] Figure 20A is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0083] Figure 20B is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0084] Figure 20C is a close-up view of an exemplary shoulder segment of the tip segment of Figure 20B at segment E-E in a first configuration.

[0085] Figure 20D is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, with the distal tip segment in a first configuration.

[0086] Figure 20EIt is in the first configuration Figure 20D A close-up view of an exemplary shoulder section of the end section of segment FF.

[0087] Figure 21A This is a close-up cross-sectional view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0088] Figure 21B It is in the first configuration Figure 21A A close-up view of an exemplary shoulder section of the end segment of segment GG.

[0089] Figure 22A This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0090] Figure 22B This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0091] Figure 22C This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0092] Figure 22D This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0093] Figure 22E This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0094] Figure 22F This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0095] Figure 22G This is a close-up side view of an exemplary catheter embodiment of the present disclosure, wherein the distal terminal segment is in a first configuration.

[0096] Figure 23 This is a side view of an embodiment of an exemplary catheter of this disclosure, wherein the distal terminal segment is in a first configuration and is positioned via an exemplary Luer interface.

[0097] Figure 24A yes Figure 23 A side view of an exemplary catheter implementation, wherein the distal terminal segment is in a first configuration and is positioned via an exemplary Luer interface.

[0098] Figure 24B yesFigure 23 side view of an embodiment of the exemplary catheter of FIG. 1, with the distal tip section in the second configuration and positioned by the exemplary luer interface.

[0099] Figure 25A is a close-up view of section H-H of FIG. 1. Figure 24A

[0100] Figure 25B is a close-up view of section I-I of FIG. 1. Figure 24B

[0101] Figure 26 is an exploded side view of an embodiment of the exemplary catheter and tip section of FIG. 1, with the distal tip section being push-loaded by the tapered lock. Figures 23-25B

[0102] Figure 27A is an exploded side view of an embodiment of the exemplary catheter of FIG. 1, with the distal tip section being push-loaded by the tapered lock. Figure 26

[0103] Figure 27B is a side view of an embodiment of the exemplary catheter of FIG. 1, with the distal tip section having been positioned by the tapered lock. Figure 27A

[0104] Figure 28A is a side view of an embodiment of the exemplary catheter of FIG. 1, with the loading tool. Figures 27A-27B

[0105] Figure 28B is a side view of an embodiment of the exemplary catheter of FIG. 1, in the second configuration. Figure 28A

[0106] Figure 29A is a side view of an embodiment of the exemplary catheter of FIG. 1, in the third configuration. Figures 28A-28B

[0107] Figure 29B is a side view of an embodiment of the exemplary catheter of FIG. 1, in the fourth configuration. Figures 28A-29A

[0108] Figure 30 is a flowchart outlining a method of using a system in accordance with aspects of the present disclosure. DETAILED DESCRIPTION

[0109] Reference is now made to the detailed description of specific examples of the present disclosure, wherein like numerals indicate functionally similar or the same elements throughout the several views. These examples address many of the deficiencies associated with conventional fixed mouth catheters, such as limited flexibility and inefficient directional suction.

[0110] ​​​​​​​​​One goal of the solution of the present disclosure is an invertible deployable catheter that is capable of providing both local flow restriction / blockage through a large distally facing mouth and is capable of navigating through tortuous regions of the vasculature to reach an occlusive clot. The flow restriction and large tip design provide significantly greater aspiration efficiency. Such advantages are also particularly beneficial in the context of stroke intervention procedures, where the vessels in the neurovascular bed are particularly small and circuitous, and thus a tailored axial and bending stiffness profile can inhibit kinking and sticking. The catheter can also be compatible with a relatively low profile access sheath and external catheter, such that the puncture wound in the patient's groin (in the case of a femoral access) can be easily and reliably closed. The catheter can also have internal and / or external low friction liner features, as well as an external polymer jacket or membrane disposed about the support structure.

[0111] Accessing various blood vessels (whether coronary, pulmonary, or cerebral) within the vasculature involves well-known procedural steps and the use of many conventional, commercially available accessory products. These products such as angiographic materials, rotating hemostatic valves, and guidewires are widely used in laboratories and medical procedures. Their function and exact construction are not described in detail when used in conjunction with the system and method of the present disclosure in the following description.

[0112] Referring to the drawings, Figure 1A A close-up view of an embodiment of one exemplary aspiration catheter 101 of the present disclosure is shown, with a distal tip segment 100 in a deployed state in a first configuration. Segment 100 (including its outer surface) can be self-deploying and can be made of a frame including struts of nitinol with interwoven platinum wire to achieve radiopacity. However, segment 100 is not limited thereto and can use any material or combination of materials as desired or required, including a polymer construction only. Segment 100 can also have internal and / or external low friction liner features, as well as an external polymer jacket or membrane disposed about the support structure. According to embodiments of the present disclosure, in a first configuration in which segment 100 is distal to an external catheter and at a treatment site in the vasculature, segment 100 is shown as having an exemplary mushroom-shaped segment 100.

[0113] In some examples, the mushroom-shaped segment 100 can include a distal portion 105 that is smaller in diameter than a proximal portion 103. In some examples, the diameter of portion 103 can be twice the diameter of portion 105, but the diameter of portion 103 can be larger or smaller relative to portion 105 as desired or required. Portion 105 can be an open, atraumatic end continuous with the internal lumen 113 of catheter 101. The profile of the outer surface of segment 100 between portions 105 and 103 can be curved. The material proximate to portion 105 can be tapered.

[0114] In Figure 1BIn the second configuration, segment 100 can be seen to be inverted around end 105 (which may also be interchangeably referred to herein as the “transition” between catheter body 117 and segment 100), which was previously the distal end but is now the proximal end of segment 100 in the second configuration. The portion of catheter 101 proximal to end 105 (e.g., the catheter body proximal to segment 100) can be stiffer or otherwise more rigid than the more flexible segment 100, allowing for inversion between the first and second configurations. In some examples, this is achieved by retracting segment 100 intravascularly to a predetermined distance radially outward in the proximal direction (e.g., ...). Figure 1A (middle) and radially outward tapering along the distal direction (e.g.) Figure 1B Switching between (Chinese and English) allows you to previously... Figure 1A The shape of the first configuration shown is inverted. Figure 1B The second configuration shape. In some examples, segment 100 is retracted by a predetermined distance, causing segment 100 to transition between the first and second configurations. The size and configuration of segment 100 in the second configuration can be set to a funnel shape, such that when deployed at the target site, segment 100 unfolds to non-invasively contact the inner vessel wall, thereby providing the maximum possible opening for aspiration and reception of clot C.

[0115] The portion on or near section 105 may be more flexible than the portion on or near section 103 to induce self-unfolding and / or inversion during delivery and inversion as section 100 forms its predetermined funnel shape of its second configuration. By incorporating the funnel shape, the clot can be gradually compressed to a smaller diameter during retrieval, allowing it to be completely aspirated through the catheter into the aspiration syringe or canister. If the clot does accumulate in the nozzle 114 of section 100, the nozzle 114 protects the clot and prevents it from dislodging while maintaining suction and the catheter 101 retracts into the sheath or external catheter.

[0116] In some examples, catheter 101 and its segment 100 may be configured to pass through a sheath or guide with an inner diameter of less than 0.090", and more ideally less than 0.087", and most preferably less than 0.085". In some examples, catheter 101 and its segment 100 may have a low delivery profile (e.g., about 0.080" or 2 mm) and may also be able to expand its distal nozzle to the size of the vessel in which the clot is located, which may be up to 5 mm. Ideally, segment 100 may expand its nozzle 114 to a diameter of at least 3 mm. In some examples, catheter 101 may allow the nozzle 114 to collapse during or after the procedure, as it may be necessary to reduce or remove any flow restrictions and allow blood and / or contrast agents to reach the distal vascular system.

[0117] Segment 100 in the first and / or second configuration may be designed such that, depending on the configuration, the dimension of the distal end is approximately equal to or slightly larger than the inner diameter of the corresponding blood vessel where the clot is located. Segment 100 may also include a flexible membrane or covering (e.g., a polymer membrane disposed therearound and stretched to present the profile of the distal frame). In some examples, the membrane may be a highly elastic material capable of unfolding with the frame to adopt a funnel shape, or it may begin to form an extra-large funnel shape and be pleated, folded, or wrinkled to reduce its profile for delivery. In some examples, the membrane may be bonded to the frame, or may wrap around the frame, or may be partially folded over the frame. Suitable membrane materials may include elastic polyurethane, such as neoprene rubber or silicone elastomers ideally having a Shore hardness of 40A or lower.

[0118] In some examples, segment 100 may begin to unfold into a first configuration when portion 105 moves distally and / or exits the corresponding delivery conduit. Then, by actuating segment 100 and inverting portion 105 around portion 103, segment 100 may move into a second inverted funnel configuration.

[0119] In some examples, segment 100 may be inverted to a second configuration by fracturing or breaking around portion 105. The terms “fracturing” and / or “breaking” are used herein to include areas of segment 100 that favor inversion and / or prevent kinking between the first and second configurations. Fracturing may include one or more localized changes in the physical properties relative to other areas of segment 100 (e.g., increased flexibility, pre-weakened areas, etc.). In some examples, the fracturing associated with portion 105 may be formed into the framework of segment 100 such that inversion and / or folding occurs after conduit 101 has been translated or otherwise retracted a predetermined distance. In some examples, fracturing of portion 105 may include localized heat treatment to make the area adjacent to portion 105 more ductile but kink-resistant. In some examples, segment 100 may be inverted upon contact with clot C.

[0120] It should be understood that segment 100 in the second and / or first configuration may be hemispherical as shown or any other desired or required shape, such as ellipse, heart, egg, cylinder, hemisphere, or any other funnel-shaped shape. For example, segment 100 may be shaped like an earplug in the first configuration and like a funnel in the second configuration.

[0121] Figure 2A It is in the first configuration Figures 1A-1B Close-up perspective view of catheter 101. Figure 2B It is in the first configuration Figures 1A-1Bis a close-up cross-sectional perspective view of a section of the catheter 101 taken along a centerline. As can be seen, the section 100 includes portions 103, 105 as previously discussed, which vary in diameter to form the previously described mushroom shape, with the lumen 113 extending continuously through the catheter 101, including the section 100. The section 100, in turn, can be overmolded with one or more reinforcing shoulder sections 107 proximate the portion 105. The one or more shoulder sections 107 can be thicker or have a variable thickness (e.g., thinner at or near the end portion 105, but relatively thicker proximally thereof where the section 100 joins with the catheter body 117).

[0122] Figure 3A is a close-up cross-sectional perspective view of an alternative catheter 101' in a first configuration. Figure 3B is a close-up view of section A-A from Figure 3A . As can be seen, the section 100 can be overmolded with one or more reinforcing shoulder sections 107 proximate the portion 105. As can be seen, the section 107 of this depicted embodiment can taper from a narrower section adjacent the portion 105 toward a thicker section where the section 107 joins with the body 117'. The body 117' here, which can include a skived outer jacket, can include an inner liner 115. In some examples, the inner liner 115 can include a PTFE liner and / or an impact layer. In this regard, the skived outer jacket can be backflowed over the coil, braid, or laser cut tube support member. The PTFE liner can be bonded over the backflow section, as shown, or the skived outer jacket can be backflowed through the braid, coil, or laser cut tube itself, which in turn can eliminate the need for an underlying outer jacket.

[0123] One or more coil members 119 can also be included for desired stiffness and / or flex characteristics of the section 100 during use (e.g., to aspirate a clot during clot retrieval). The coil members 119 can include the same flex characteristics and be equally spaced apart. In other examples, the coil members 119 can include variable flex characteristics and / or spacing therebetween, as needed or required for the treatment site or procedure. A jacket 116 can also be included in communication with the coil members 119 and the liner 115. For example, the coil members 119 can be disposed inside the jacket 116, nested with the jacket, embedded in the jacket, and / or generally surrounded by the jacket. In some examples, the jacket 116 can include a backflow polymer jacket.

[0124] Figure 4A is a close-up view of an embodiment of a suction catheter 401 of the present disclosure, with a distal tip section 400 in a first configuration in a deployed state, similar to the catheter 101 and section 100 as previously described. However, in this example, the section 400 includes a double mushroom shape and / or an invertible hemispherical shape (as shown) in the first configuration and a double funnel (as shown) in a second configuration. Figure 4A is a close-up view of an embodiment of a suction catheter 401 of the present disclosure, with a distal tip section 400 in a first configuration in a deployed state, similar to the catheter 101 and section 100 as previously described. However, in this example, the section 400 includes a double mushroom shape and / or an invertible hemispherical shape (as shown) in the first configuration and a double funnel (as shown) in a second configuration.Figure 4B The dual configuration of this example is configured to achieve multiple sequential sealing layers with a corresponding blood vessel wall. Figures 4A-4B The enlarged arrows shown indicate exemplary suction flow directions for each depicted configuration. In some examples, each sealing member 432, 434 shown as sequentially arranged can collectively achieve multiple sequential sealing layers. Distal sealing member 432 can include a distal portion 405 and a proximal portion 403, while proximal sealing member 434 can include a distal portion 425 and a proximal portion 423 and a corresponding open end 424. The diameter of member 432 can be smaller than the diameter of proximal sealing member 434. However, in other examples, the diameter of member 432 can be larger than the diameter of proximal sealing member 434. Figures 4A-4B In both the first and second configurations of 400, the diameters of portions 403 and 423 of sealing members 432, 434, respectively, are larger than the outer diameter of catheter body 417.

[0125] Sealing members 432, 434 can be configured to invert about portions 405 and 425, respectively, and in certain examples, invert substantially simultaneously, in sequence (e.g., member 432 before member 434, or vice versa), or manually by an operator-controlled corresponding actuation system. In some examples, sealing members 432, 434 can be selectively and / or sequentially spaced apart such that when compressed in a guide sheath or delivery catheter for advancement, each sealing member does not overlap, thereby enabling the size of the sheath and / or delivery catheter to be maximized relative to the balloon guide size. Each of members 432, 434 can also be capable of inverting into the second configuration, similar to segment 100 as previously described.

[0126] Figure 5 is a close-up view of another example catheter 501 embodiment of the present disclosure, where distal tip segment 500 is in a first configuration and includes multiple sealing members 532, 534, 536, similar to 4A through 4C. Figure 4B As can be seen, in both the first and second configurations, members 532, 534, 536 can include varying diameters, where the diameter is largest proximally and gradually moves distally to member 532, which has the smallest diameter.

[0127] The varying diameters as depicted allow segment 500 to seal over a wide range of blood vessel diameters as well as increase redundancy to maintain a seal with a corresponding blood vessel. The diameters of members 532, 534, 536 can vary as needed or required. For example, the outer diameter of member 536 associated with portion 533 can be twice the diameter of member 534 at portion 523, which in turn can be twice the diameter of member 532 at portion 503. However, the solution is not limited as such, and the diameters and / or spacing of members 532, 534, 536 can vary as needed or required. Furthermore, while in the example shown, the diameter of member 532 is smaller than the diameter of member 534, which in turn is smaller than the diameter of member 536, the solution is not limited as such, and the diameters of members 532, 534, 536 can vary as needed or required. Figure 5Only three components 532, 534, and 536 are shown, but fewer or more sealing components are contemplated as needed or required. Each of components 532, 534, and 536 can also be inverted into a second configuration, similar to section 100 as previously shown and described.

[0128] Figure 6 This is a close-up view of another exemplary embodiment of the catheter 601 of this disclosure, wherein the distal distal segment 600 is in a first configuration. It can be seen that the segment 600 may include different diameters, wherein a crease or fracture 606 is positioned between the larger diameter of the distal portion 605 and the proximal portion 603 to form a continuous partially pear-shaped segment 600. The crease or fracture 606 may allow the use of a single sealing member shape (instead of...) Figures 4A-4B Multiple sealing methods or Figure 5 Multiple sealing members (of different diameters) seal the corresponding vessel walls within a wide vessel diameter range. The diameters of portions 603 and 605 can be varied as needed or required. Each of portions 603 and 605 can also be inverted into a second configuration, similar to segment 100 as described above.

[0129] Figure 7A This is a close-up cross-sectional view of an embodiment of an exemplary distal end segment in a first configuration having one or more longitudinal channels, grooves, ridges, and / or recesses. These features may be configured to form the depicted end segment and have their funnel shape when in use in a second configuration. Figure 7A The described implementation also provides improved radial force and pushability for the corresponding catheter and distal end segment, and can also help induce a specific folding pattern when retracting through the outer sheath.

[0130] Figure 7B Similar end sections are depicted, but with spiral (or in other words, twisted) channels, grooves, ridges, and / or recesses. Figure 7C A similar end section was depicted, but with circumferential annular channels, grooves, ridges, and / or recesses. It should be understood that... Figures 7A-7C Any of the examples depicted may be used alone or in combination with one or more of the depicted exemplary channels, grooves, ridges and / or recesses, as well as other features contemplated for use with the conduits and corresponding terminal segments of this disclosure. Figures 7A-7C The depicted section may also include a micro-funnel opening at the distal mouth to reduce clot shear when the sealing member is not inverted.

[0131] Figure 8A This is a close-up view of an embodiment of an exemplary catheter of this disclosure, wherein the distal terminal segment is in a first configuration. Figures 8B-8Eis an illustration of a close-up view of an exemplary shoulder segment at or near the distal portion 805. More specifically, Figures 8B-8E The shoulder segment of can include a transition segment from the substantially elongated catheter body 817 to the portion 805. As mentioned previously in connection with the catheter 101, the transition can include a flex feature (e.g., a thin region, one or more indentations, one or more creases, one or more breaks, etc.) that will reduce the force for inverting from the first configuration to the second configuration funnel shape. In other examples, the transition can include one or more stiffening elements (e.g., ribs, thickened regions such as stiffening the shoulder segment, a harder or more rigid material, etc.). The one or more stiffening elements can be configured to increase the resiliency to collapse the segment 800 under vacuum. The thickness of the segment 800 can vary as it tapers radially outward such that the outermost portion in contact with the vessel wall is super-soft and the inner portion near the tubular portion is rigid and resistant to collapse under vacuum.

[0132] Figure 9 depicts an embodiment of an exemplary catheter 901 with a tip segment 900 in a first configuration delivered into a clot C in a blood vessel V. As can be seen, blood between the segment 900 and the clot C flows proximally through the catheter 901 (indicated by the large arrows within the blood vessel). The proximal end of the catheter 901 can include a port 950 that can be switched to open or close. When open, the port 950 allows fluid trapped between the segment 900 and the clot C to escape as the catheter 901 is advanced, indicated by the large arrows adjacent to the port 950. Otherwise, if closed, the segment 900 (and its corresponding sealing member) can act like a piston in the blood vessel V and cause the clot C to move distally. In Figure 9 In, it should be understood that blood is able to flow around the segment 900 because the segment 900 can be smaller than the surrounding blood vessel V. However, the port 950 can be reduced to allow flow around the segment 900. The port 950 is advantageous when the segment 900 is sealed to the blood vessel V and advanced distally.

[0133] Figure 10 depicts an embodiment of an exemplary catheter 1000 with a tip segment 1001 in a first configuration delivered into a clot. As can be seen, blood between the segment 1001 and its sealing member and the clot C (as indicated by the arrows within the blood vessel) passes through the hole 1060 and flows proximally between the catheter 1000 and the blood vessel V. The hole 1060 can be selectively sized and / or positioned in the segment 1001 to allow a predetermined percentage of blood to flow proximally as the tip segment 1001 is advanced, thereby avoiding pushing the clot C distally while having enough of a predetermined percentage of occlusion to direct suction to the clot C when administered. Additionally, once the tip segment 1001 is inverted to form a funnel in a second configuration, the hole 1060 can close to allow maximum suction.

[0134] Figure 11 An embodiment of an exemplary catheter 1100 is depicted with the tip segment 1101 in a first configuration delivered to a clot. It can be seen that blood between the segment 1101 and its sealing member and the clot C flows proximally through the one-way valve 1170. The valve 1170 can be formed on or otherwise positioned on the catheter 1100 proximally of the segment 1101. While only one valve 1170 is shown in Figure 11 more valves can be used and included as desired or required. In some examples, one or more valves 1170 can be configured to close during suction to direct the vacuum to the face of the clot C and open to allow blood to flow to the vessel proximally of the segment 1101 when the segment 1101 is advanced in its first configuration in the vessel V.

[0135] Figure 12A is a close-up view of an embodiment of an exemplary catheter 1201 with the distal tip segment 1200 in a first configuration during a clot suction procedure in a vessel V. Figure 12B is a close-up view of the segment 1200 in a second configuration during a clot suction procedure in a vessel V. The segment 1200 functions as a plunger at the moment it is in its first configuration or second configuration. In some examples, the proximal port 1250 can be opened during advancement to the treatment location so as not to interfere with the clot C. Upon reaching the clot C, the port 1250 can be closed so that the tip segment 1200 can be advanced and retracted in a repetitive motion to dislodge the clot C from the vessel V and break any adhesive forces before suction is applied and / or the clot is removed.

[0136] In some examples, the tip segment 1200 of the catheter 1201 is configured to retract a predetermined distance and advance in a repetitive motion to dislodge the clot C from the vessel C in the proximal and distal directions. In some examples, the tip segment 1200 of the catheter 1201 is configured to retract to invert the depicted funnel shape in the second configuration and dislodge the clot C from the vessel V in the proximal direction only. In some examples, the tip segment 1200 of the catheter 1201 is configured to advance to recover from the second configuration to the first configuration and dislodge the clot C from the vessel V in the distal direction.

[0137] Figure 13is a schematic view of another example catheter 1301 of the present disclosure, in which the tip segment 1300 is shown in use with a sheath S and balloon guide catheter B in first and second (dashed) configurations. As shown, the tip segment 1300 can be advanced through the outer balloon B and / or sheath S to reach a treatment site, such as an occlusion n in the internal carotid artery (ICA). To minimize profile, the tip segment 1300 can be inverted into the second configuration (e.g., a funnel shape) and / or wrapped circumferentially prior to insertion into the guide sheath S. When the inverted and / or wrapped tip segment 1300 exits the guide sheath S in the ICA, the segment 1300 can resume its first configuration shape as it grips the vessel wall V and advances distally to the face of the clot C. Then, prior to aspiration, the segment 1300 in the first configuration can be slightly retracted to invert into the funnel shape of the second configuration. Alternatively, the tubular portion 1317 of the tip (e.g., the substantially elongate catheter body segment previously described) covered by the tip segment 1300 can be compressible, such that the tip segment 1300 and the tubular portion 1317 in the first configuration can be compressed for low profile advancement through the outer guide sheath S.

[0138] Any of the catheters disclosed herein, including the catheter 1301, can also be used with one or more stentriever, which can be understood to include the features more clearly described in U.S. Patent Application No. 16 / 021,505 and U.S. Patent Nos. 10,292,723; 10,299,811; 10,363,054; 8,777,976; 8,852,205; 9,402,707; 9,445,829; and 9,642,639, and these patents are incorporated by reference in their entirety as if set forth verbatim herein. Any of the catheters disclosed herein can also direct an aspiration vacuum to the face of the clot while the stentriever can hold the composite clot (composed of the friable region and the fibrin-rich region) together, preventing embolization and aiding in the removal of the clot from the vessel wall. With the funnel shape of the tip segment 1300 in the second configuration, the combined stentriever retraction and aspiration can act together to increase the likelihood of first pass success in removing the clot C. In some examples, the funnel shape of the tip segment 1300 can reduce clot shearing upon entry into the catheter 1301, stop flow to protect the distal vessel from new area embolization, and also direct an aspiration vacuum to the face of the clot while the stentriever holds the composite clot (composed of the friable region and the fibrin-rich region) together, preventing embolization and aiding in the removal of the clot from the vessel wall.

[0139] Figure 14Ais a close-up perspective view of an exemplary embodiment of a catheter 1401, where the distal tip section 1400 in the first configuration has one or more external ribs 1420. As shown, the external ribs 1420 can be one or more axially positioned external ribs 1420 that project radially outward along the outer surface of the section 1401, and can extend between the proximal portion 1403 and the distal portion 1405 of the section 1400. The one or more ribs 1420 can be configured to maintain structural integrity while minimizing the volume of material that needs to collapse for passage through the section 1400. Figure 14B is a cross-sectional view of the section 1400 taken along a portion between the ribs 1420, while Figure 14C is a cross-sectional view of the section 1400 taken along one of the one or more ribs 1420.

[0140] As can be seen, Figure 14C The ribs 1420 in include a cross-section that is substantially thicker (e.g., at least twice as thick) than the non-ribbed portions of the section 1400. In some examples, the ribs 1420 can include a maximum width at or near the portion 1403, and taper from there toward the portion 1405 to a smaller width. However, in other examples, the ribs 1420 can include a relatively constant thickness and / or width throughout. As shown, the tip section 1400 can include six (6) radially aligned ribs 1420, but can include a fewer or greater number of ribs 1420 as desired or required.

[0141] Figure 15A is a close-up perspective view of an exemplary embodiment of a catheter 1501, where the distal tip section 1500 in the first configuration has one or more internal ribs 1520. As shown, the internal ribs 1520 can be one or more axially positioned internal ribs 1520 that project radially inward along the inner surface of the section 1501, and can extend between the proximal portion 1503 and the distal portion 1505 of the section 1500. Advantageously, the positioned ribs 1520 as shown and described provide a relatively smooth interface for the blood vessel and clot during advancement and aspiration, respectively. The one or more ribs 1520 can be configured to maintain structural integrity while minimizing the volume of material that needs to collapse for passage through the section 1500.

[0142] Figure 15B is a rear perspective view of the section 1500. As can be seen, Figure 15BThe ribs 1520 in the distal tip section 1500 include a cross-section that is substantially thicker (e.g., at least twice as thick) than the non-ribbed portions of the section 1500. In some examples, the ribs 1520 can include a maximum width at or near the portion 1503 and taper from there toward the portion 1505 to a smaller width. However, in other examples, the ribs 1520 can include a relatively constant thickness and / or width throughout. As shown, the tip section 1500 can include three (3) radially aligned ribs 1520, but can include a fewer or greater number of ribs 1520 as desired or required.

[0143] Figure 16A is a close-up perspective view of an embodiment of an example catheter 1601, where the distal tip section 1600 in a first configuration has one or more internal ribs 1620. As in Figure 16B As more clearly shown in the rear plan view of Figure 16C and Figure 16D the internal ribs 1620 can be one or more axially positioned internal ribs 1620 that project radially inward along the inner surface of the section 1600 and can extend between the proximal portion 1603 and the distal portion 1605 of the section 1600. Advantageously, the positioned ribs 1620 as shown and described provide a relatively smooth outer surface interface for the blood vessel and clot during advancement and aspiration, respectively. The ribs 1620 can be formed partially, as

[0144] As more clearly shown in the rear plan view of Figure 16C and Figure 16D the internal ribs 1620 can include a cross-section that is thicker than the non-ribbed portions of the section 1600. In some examples, the ribs 1620 can include a maximum width at or near the portion 1603 and taper from there toward the portion 1605 to a smaller width. However, in other examples, the ribs 1620 can include a relatively constant thickness and / or width throughout. As shown, the tip section 1600 can include six (6) radially aligned ribs 1620. However, the section 1600 is not limited as such and can include a fewer or greater number of ribs 1620 as desired or required. While the depicted ribs 1620 are shown as equally spaced apart, it is contemplated that they can be positioned at different intervals.

[0145] Figure 17A is a close-up perspective view of an embodiment of an example catheter 1701, where the distal tip section 1700 in a first configuration has one or more internal ribs 1720. As in Figure 17BAs more clearly shown in the rear plan view, the interior ribs 1720 can be one or more axially positioned interior ribs 1720 that project radially inward along the inner surface of the section 1700 and can extend between the proximal portion 1703 and the distal portion 1705 of the section 1700. Advantageously, the positioned ribs 1720 as shown and described provide a relatively smooth outer surface interface for the blood vessel and clot during advancement and aspiration, respectively. The ribs 1720 can be formed partially, as Figure 17C As more clearly shown in the rear plan view, the interior ribs 1720 can be one or more axially positioned interior ribs 1720 that project radially inward along the inner surface of the section 1700 and can extend between the proximal portion 1703 and the distal portion 1705 of the section 1700. Advantageously, the positioned ribs 1720 as shown and described provide a relatively smooth outer surface interface for the blood vessel and clot during advancement and aspiration, respectively. The ribs 1720 can be formed partially, as

[0146] The section 1700 can include one or more openings 1722 disposed on or adjacent the distal portion 1705 that allow blood flow in a controlled manner from a location proximal of the section 1700 to a location distal of the section 1700 during use in a blood vessel. The one or more openings 1722 are configured to prevent blood vessel collapse at high aspiration by allowing a portion of the blood to flow through the openings 1722 if the length of the blood vessel is positioned between the sealed section 1700 and the sealed clot. The one or more openings 1722 can also resist air entrainment during advancement through an outer catheter and distal displacement of blood when advancing through a blood vessel. The one or more openings 1722 at or adjacent the distal portion 1705 can be separate from (e.g., radially located between adjacent ribs 1720) and / or can be included in one or more of the ribs 1720.

[0147] Figure 18A is a close-up perspective view of an embodiment of an example catheter 1801 with the distal tip section 1800 in a first configuration. The depicted example section 1800 is configured to seal in a blood vessel at or adjacent the distal portion 1805 with a relatively thin wall, such that the portion 1813 immediately proximal thereof is relatively thick. The wall between the portions 1803 and 1805 can be thicker than the shoulder defined at or adjacent the portion 1805, which in turn helps the collapsibility of the section 1800 and the overall stiffness of its outer diameter.

[0148] Figure 18Bis a close-up perspective view of an exemplary embodiment of a catheter 1901, with a distal tip section 1900 in a first configuration. The exemplary section 1900 depicted is configured to seal in a blood vessel with a relatively thin wall at or near a distal portion 1905, and to taper to thinner at a portion 1903, such that a portion 1913 immediately proximal thereto is relatively thicker. The wall between portions 1903 and 1905 can be relatively thin to reduce the collapse volume of the section 1900, with a relatively thicker wall along a portion 1917 to achieve overall stiffness of the catheter 1901.

[0149] Figure 19A is a close-up perspective view of an exemplary embodiment of a catheter 2001, with a distal tip section 2000 in a first configuration. Figure 19B is Figure 19A is a close-up view of an exemplary shoulder section of section C-C of a tip section of The exemplary section 2000 depicted is configured to seal in a blood vessel with a relatively thin wall at or near a distal portion 2005, including a portion 2005a disposed on an exterior curved surface thereof, such that a portion 2013 immediately proximal thereto is relatively thicker. The wall between portions 2003 and 2005 can remain relatively thinner than a shoulder defined at or near portion 2005, which in turn facilitates collapsibility of the section 2000 and overall stiffness of its outer diameter. The section 2000 can include one or more support structures, such as one or more nitinol braid or braided sections of a memory alloy material, which together can include a relatively large proximally extending radius and relatively strong radial support and corresponding vessel sealing capability.

[0150] Figure 19C is a close-up perspective view of an exemplary embodiment of a catheter 2101, with a distal tip section 2100 in a first configuration. Figure 19D is Figure 19C is a close-up view of an exemplary shoulder section of section D-D of a tip section of The exemplary section 2100 depicted is configured to seal in a blood vessel with a relatively thick wall at or near a distal portion 2105, such that the section 2101 must first be inverted distally before it can be advanced distally in a blood vessel. The wall between portions 2103 and 2105 can also be relatively thick. Moreover, since the section 2101 extends proximally only a short distance above the mouth of the catheter 2101, the section 2100 can be easily inverted for advancement and easily restored once exposed from the catheter in a blood vessel large enough to allow inversion. The thicker wall of the section 2100 also helps to bias the material toward the shape it is formed into.

[0151] Figure 20Ais a close-up perspective view of an exemplary embodiment of a catheter 2201, where the distal tip segment 2200 in a first configuration has a "bell" shape and a relatively thin outer membrane. The exemplary segment 2200 depicted is configured to seal in a blood vessel at or near a distal portion 2205 with a relatively thin wall, such that the portion 2213 immediately proximal thereto is relatively thick. The wall between portions 2203 and 2205 can remain thinner than a shoulder defined at or near portion 2205, which in turn facilitates collapsibility of segment 2200 and overall stiffness of its outer diameter.

[0152] Figure 20B is a close-up perspective view of an exemplary embodiment of a catheter 2301, where the distal tip segment 2300 in a first configuration has a "bell" shape and a varying thickness along it. Figure 20C is a close-up perspective view of an exemplary shoulder segment of segment E-E of tip segment 2300 of Figure 20B is a close-up perspective view of an exemplary shoulder segment of segment E-E of tip segment 2300 of

[0153] Figure 20D is a close-up perspective view of an exemplary embodiment of a catheter 2401, where the distal tip segment 2400 is in a first configuration. Figure 20E is a close-up perspective view of an exemplary shoulder segment of segment E-E of tip segment 2400 of Figure 20D is a close-up perspective view of an exemplary shoulder segment of segment E-E of tip segment 2400 of

[0154] Figure 21A is a close-up perspective view of an exemplary embodiment of a catheter 2501, where the distal tip segment 2500 in a first configuration has a "bell" shape that terminates in a relatively large proximal extension radius, and where the "bell" shape is relatively shorter than the "bell" shaped segments previously described. In turn, segment 2500 is specifically configured to allow relatively smooth inversion when pulled proximally through an outer sheath. Figure 21B is a close-up perspective view of an exemplary shoulder segment of segment E-E of tip segment 2500 of Figure 21Ais a close-up view of an exemplary shoulder section of section E-E of distal section 2500. The depicted exemplary section 2500 is configured to seal in a blood vessel at or near a distal portion 2505 including portion 2505a with a relatively thin wall, and then thicken at or near portion 2505b (and proximally thereof toward portion 2517) while being relatively thin at or around portion 2503, as opposed thereto.

[0155] Figure 22A is a close-up side view of another exemplary distal tip section 2600 in a first configuration. Here, section 2600 can be formed over a braid, wire, or laser cut support frame. Such a support frame can allow for the use of very thin films (e.g., 5 microns to 50 microns) without losing the integrity of the shape of section 2600, such that section 2600, in combination with the rest of its catheter, can withstand the suction forces, clot uptake, and compression in and through a blood vessel of an external catheter. In some examples, section 2600 can include a support frame made of a metal and / or a polymeric material. Metal polymers and certain heat-resistant polymers can accept films of section 2600 through reflow, molding, and compression molding processes. In other examples, a dipping process can be used with a metal and / or polymeric support frame to construct section 2600, where the polymer is compatible with the solvent used for the film dipping material.

[0156] Figure 22B is a close-up side view of another exemplary distal tip section 2700 in a first configuration, where the support frame is constructed of a plurality of wires. Figure 22C is a close-up side view of another exemplary distal tip section 2800 in a first configuration, where the support frame is laser cut.

[0157] Figure 22D is a close-up side view of another exemplary distal tip section 2900 in a first configuration, in this example, section 2900 can include one or more polymeric layers, such as layers 2950, 2960. In some examples, film layer 2950 can be adhered to film 2960, such that layer 2950 can be a more robust longitudinal support member with a corresponding increased bending stiffness relative to film 2960, which in turn provides sufficient radial support to section 2900. Figure 22E is a close-up side view of another exemplary distal tip section 3000 in a first configuration, which is similar to section 2900, except that section 3000 includes an additional outer film layer positioned over one or more more robust longitudinal support members here (rather than under them as in section 2900).

[0158] Figure 22Fis a close-up lateral view of another example distal tip segment 3100 in a first configuration, in this example, the segment 3100 can include one or more polymer layers, such as layer 3107. Layer 3107 can be a film that is pliable but strong enough to provide support through one or more cutouts with windows 3110 adhered. Windows 3110 can be porous to further increase the ability to collapse with minimal volume, while also allowing for controlled passage of blood flow. In this embodiment, the passage of blood flow can help to keep the relatively thin film of segment 3100 in its formed shape during aspiration, similar to a parachute. Figure 22G is a close-up lateral view of another example distal tip segment 3200 in a first configuration, similar to segment 3100, except that segment 3200 includes windows 3210 that extend more proximally, including in some examples all the way to the proximal end of segment 3100.

[0159] Figure 23 is a lateral view of an embodiment of a catheter 3301, where distal tip segment 3300 is in a first configuration and positioned through an example luer interface 3470. As shown, segment 3300 can include a collapsible shaft portion 3337 (e.g., a shaft constructed of a woven frame) beneath the outer surface of segment 3300. When advanced or collapsed through the luer interface 3471 of an outer catheter, the diameter of collapsible shaft portion 3337 can be reduced in order to provide additional space for the relatively softer segment 3300 to collapse or fold into the inner diameter (ID) of the outer shaft. To accomplish this, the support frame of portion 3337 can include a woven frame as previously described. However, the support frame is not limited to this and can be a wire form or a laser cut stent-like tube, with an elastomeric polymer or a polymer with a reflow through structure or molded over structure elastic strain recovery properties. Just proximal of portion 3337, catheter 3301 can include a non-collapsible shaft portion 3335 in some examples.

[0160] In some examples, portion 3337 can have one or more axial ridges 3342 to enhance pushability and anti-tensile elongation of the shaft. The one or more axial ridges 3342 can stop short of tip segment 3300 (e.g., positioned just proximal thereof), extend to the distal end of portion 3337, or extend to the distal end of portion 3337 and proximally recover through the wall of segment 3300.

[0161] In some examples, the portion 3337 can be fitted with a ring or coil marker band 3330 to enhance visibility. Alternatively, radiopaque wire or coil can be added to the frame of the portion 3337 (or other marker inserts can be included in the laser cut support frame, or radiopaque filler can be included in the softer material of the segment 3300). The catheter 3301 can also include a series of polymer sheaths 3350 with different softness properties to provide variable flexibility and pushability. The sheaths 3350 can be backflowed over a PTFE lining of a low-friction lumen, as well as a support structure over the PTFE lining (e.g., coils, braid, laser tube patterns, ridges, or combinations thereof) to provide kink resistance, torsion, and pushability properties.

[0162] Turning to Figure 24A , a side view of the catheter 3301 is shown with the segment 3300 in a first configuration within a guide catheter 3400 having exemplary luer interfaces 3440, 3470. Figure 24B A similar view is shown, but the segment 3300 has now been translated distally to the distal side of the catheter 3400. As shown, the catheter 3301 (including the segment 3300) has a reduced outer diameter for passing therethrough while inside the catheter 3400, but once distal thereto, the segment 3300 can automatically deploy.

[0163] Figure 25A is a close-up view of the catheter 3301, 3400 of Figure 24A at segment H-H, more clearly showing the terminal segment 3301 when collapsed within the catheter 3400. Figure 25B is a close-up view of the catheter 3301, 3400 of Figure 24B at segment I-I, more clearly showing the terminal segment 3301 when at least a distal portion of the catheter 3400 and the portions 3305, 3303 are deployed to a larger diameter than the previously collapsed diameter. In certain examples, the maximum diameter formed between the portions 3303, 3305 can be greater than the outer diameter of the catheter 3400. In some examples, the maximum diameter can be at least twice the outer diameter of the catheter 3400. However, the segment 3300 is not limited as such, and any diameter greater or lesser can be used as desired or required.

[0164] Turning to Figure 26which is an exploded side view of the catheter 3400, 3301 and corresponding tip section 3300 being push loaded through a taper lock luer hub 3450. The section 3300 is configured to allow a reduction in diameter when advanced through the taper lock luer hub 3450 of the outer catheter 3400. In some examples, the luer hub 3450 can be a bespoke luer hub having an inner taper. For example, the luer hub 3450 can include a surface 3457 that can facilitate a tapered stage to reduce the inner diameter reduction, such that the luer hub 3450 can be positioned with or otherwise threaded onto the tapered lock luer hub 3450 and provide a seamless transition to reduce the diameter of the section 3300 in the stage. The luer hub can also include an outer mounting flange 3459 having a maximum diameter of the luer hub 3450, and a distal end 3453 opposite thereof having a minimum diameter of the luer hub 3450.

[0165] The luer hub 3450 can include a split design, such that it can be removed from the assembly after the section 3300 has been passed through and reduced in diameter. In some examples, removing the loading luer hub 3450 can ensure that it does not reduce the usable length of the shaft of the catheter 3301, and the split design can be removed by twisting apart, pulling apart a snap fit feature, or pulling apart a magnetic binding side of the luer hub 3450.

[0166] Turning to Figure 27A which is an exploded side view of the catheter 3301 being push loaded through a taper lock 3450 and a second loading luer hub 3480. Figure 27B is the catheter 3301 having been positioned through the locks 3450, 3480. Figure 27A is a side view of an embodiment of the catheter 3301. As shown, the OD of the luer hub 3450 can be shaped to fit within the ID of the luer hub 3480, which can be a solid loading luer hub. In this regard, the inclusion of the luer hub 3480 does not reduce the usable length of the catheter shaft associated with the catheter 3301, and the luer hub 3480 does not need to be removed to maximize the usable length of the catheter 3301. The catheter 3301 can also be compatible with a hemostatic valve.

[0167] Turning to Figure 28A which is a side view of the catheter 3301 being push loaded distally by a loading tool 3460 incorporating the previously described features to invert the section 3300 distally, as shown, with the large arrow indicating the directional movement. In Figure 28B the tool 3460 has been translated distally from Figure 28A until the inverted section 3000 is aligned with the distal end of the tool 3406.

[0168] Figure 29AA third configuration is now shown in which the distal end of the tool 3460 has been inserted into the luer hub 3450 of the catheter 3400 along with the inverted section 3300. In other examples, the luer hub 3450 can instead be a hemostatic valve connected to the luer hub 3450. Turning to Figure 29B , a fourth configuration is shown in which the section 3300 has been advanced distally through the catheter 3400 until distally exiting, preferably in a blood vessel having an ID greater than the OD of the section 3300. In some examples, distal exiting as described and shown can allow the section 3300 to resume its original "earplug" shape, as shown in Figure 29B . The section 3300 can then be advanced distally through the blood vessel to the treatment site.

[0169] Figure 30 is a flowchart showing method steps for using any of the catheters disclosed herein with an occlusive thrombus from a blood vessel. The method steps can be implemented by any of the example systems, devices, and / or apparatuses described herein or by means known to those of ordinary skill in the art. See method 3000 outlined in Figure 30 , step 3010 describes translating the aspiration catheter at least partially distally to a sheath or delivery catheter, thereby moving a distal tip section of the aspiration catheter from a collapsed configuration to a first deployed configuration. Step 3020 describes retracting the distal tip section, thereby causing the distal tip section to invert about a transition between the distal tip section and a catheter body into a second deployed configuration comprising a deployable tip having an open funnel-like distal mouth having a diameter greater than a diameter of the transition.

[0170] In some examples of the method 3000, the distal tip section can also be configured to not invert when pulled proximally through the blood vessel and to invert only when retracted by an external sheath.

[0171] In some examples of the method 3000, aspiration can be applied through the catheter, depending on how the user has deployed the flow restriction and / or seal, to stimulate the clot into the funnel mouth of the catheter. If aspiration alone is not sufficient to move and capture the thrombus, or if additional clamping of the clot is needed during the initial aspiration and movement, a mechanical thrombectomy clot retrieval device can be advanced to the target. The mechanical thrombectomy device can then be deployed to capture the clot using any method generally known in the art. Aspiration can continue throughout this step or at intervals selected by the user to prevent backflow of blood and maintain a tight clamp on the clot. In some examples, aspiration and pulling of the clot with a stent retriever can be optimal to increase the chances of a first pass success.

[0172] In some examples of the method 3000, the captured clot and clot retrieval catheter can be withdrawn from the patient, or the clot retrieval catheter can be left in place to maintain access as the mechanical thrombectomy clot retrieval device is withdrawn from the patient along with the clot. This step can also involve using known techniques to carefully inject contrast through the system at low pressure to determine if the vessel is open if a clot is observed in the aspiration source and / or the thrombectomy device and flow in the clot retrieval catheter is not blocked. If the vessel is open, the clot retrieval catheter can be removed. If the obstruction remains, aspiration, thrombectomy, or a combination of these can be repeated additional times until the vessel is open.

[0173] In some examples, the aspiration catheter and corresponding system are configured to form a clot retrieval catheter that can provide localized flow restriction and / or blockage as well as a large clot-facing mouth. In some examples, the aspiration catheter of the present disclosure is capable of navigating through tortuous neurovascular systems to reach occluded clots and is highly flexible. In some examples, the aspiration catheter is compatible with a relatively low-profile access sheath / catheter such that a puncture wound in the patient’s groin (e.g., a femoral access) can be easily and reliably closed. In some examples, the aspiration catheter and corresponding system of the present disclosure are particularly suitable for removing clots from cerebral arteries of patients with AIS, coronary native or graft vessels of patients with MI, and pulmonary arteries of patients with pulmonary embolism, as well as other peripheral arterial and venous vessels occluded by clots.

[0174] The present disclosure is not limited to the described examples, which can vary in configuration and detail. The terms “distal” and “proximal” are used throughout the preceding description and refer to positions and directions relative to the position of the treating physician. Likewise, “distal” or “distally” refers to a position away from or in a direction away from the physician. Similarly, “proximal” or “proximally” refers to a position near or in a direction toward the physician.

[0175] In describing example embodiments, terminology is used for the purpose of clarity. Each term is intended to be construed in its broadest and ordinary sense, and is intended not to be limited to a narrower sense unless specifically so limited in the specific context of the description. It is further to be understood that any step or verse recited to method recitations can be performed in a different sequence that is not necessarily the same as that which is recited. Similarly, it should be understood that any use of “can” does not imply that a stated step or verse must be performed, but rather that it is optional and can or can not be performed. It is also to be understood that recitation of one or more steps or verses does not preclude the presence of additional steps or verses between those steps or verses that are clearly identified as being present.

[0176] As discussed herein, a “patient” or “individual” can be a person or any animal. It should be understood that an animal can be any applicable type, including but not limited to mammals, veterinary animals, livestock, or pets. For example, an animal can be a laboratory animal specifically selected to have certain characteristics similar to humans (e.g., rats, dogs, pigs, monkeys, etc.).

[0177] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated values, for example, “about 90%” may refer to a range of values ​​from 71% to 99%.

[0178] "Comprising," "containing," or "including" means that at least the named compound, element, particle, or method step is present in the composition, article, or method, but does not exclude the presence of other compounds, materials, particles, or method steps, even if the other such compounds, materials, particles, or method steps have the same function as the named ones.

[0179] It should also be noted that, unless the context clearly indicates otherwise, the singular forms “a” and “the” used in this specification and the appended claims include plural references. A range may be expressed herein as “about” or “approximately” a particular value and / or “about” or “approximately” another particular value. When expressing such a range, other exemplary embodiments include from one particular value and / or to another particular value.

[0180] The description contained herein is an example of embodiments of this disclosure and is not intended to limit the scope of this disclosure in any way. While specific examples of this disclosure have been described, various modifications may be made to the apparatus and methods without departing from the scope and spirit of this disclosure. For example, while the examples described herein relate to specific components, this disclosure includes other examples such as using various combinations of components to achieve the function, using alternative materials to achieve the function, combining components of the various examples, combining components of the various examples with known components, etc. This disclosure contemplates replacing the components shown herein with other well-known and commercially available products. These modifications will generally be apparent to those skilled in the art to which this disclosure pertains and are intended to fall within the scope of the following claims.

Claims

1. An aspiration catheter comprising: a distal tip section disposed on or near a distal end of the catheter, the distal tip section invertable about a transition between a catheter body and the distal tip section between a first configuration and a second configuration; the catheter configured such that retracting the distal tip section causes the distal tip section to invert about the transition from the first configuration to the second configuration, the second configuration comprising a deployable tip having an open funnel-like distal mouth comprising a diameter greater than a diameter of the transition, wherein the distal tip section comprises a plurality of sealing members configured to invert from the first configuration in which open ends face proximally to the second configuration in which the open ends face distally.

2. The aspiration catheter of claim 1, wherein the first configuration and the second configuration are part of a deployed configuration of the distal tip section distal of a guide catheter or sheath.

3. The aspiration catheter of claim 1, the first configuration of the distal tip section comprising a mushroom-shaped hemispherical section configured to invert into the second configuration and form the open funnel-like distal mouth by retracting a predetermined distance.

4. The aspiration catheter of claim 3, the mushroom-shaped hemispherical section being a mirror image of the other between the first configuration and the second configuration.

5. The aspiration catheter of claim 1, each of the plurality of sealing members configured to invert from a mushroom-shaped section in which open ends face proximally in the first configuration to the open funnel-like distal mouth in which the open ends face distally in the second configuration.

6. The aspiration catheter of claim 5, each sealing member comprising a hemispherical shape in the first configuration and the second configuration, the hemispherical shape being a mirror image of the other substantially opposite each other between the first configuration and the second configuration.

7. The aspiration catheter of claim 5, each sealing member corresponding to an individual funnel mouth in the second configuration.

8. The aspiration catheter of claim 5, each sealing member corresponding to a plurality of sealing layers with a corresponding blood vessel wall.

9. The aspiration catheter of claim 5, each sealing member invertable about a respective transition.

10. The aspiration catheter of claim 5, each sealing member selectively spaced along the catheter body.

11. The aspiration catheter of claim 1, the distal tip section comprising a proximal portion and a distal portion, the distal portion comprising a diameter less than a diameter of the proximal portion, the diameter of the proximal portion being at least twice the diameter of the distal portion.

12. The aspiration catheter of claim 1, the distal tip section comprising a proximal portion and a distal portion, the distal portion comprising a diameter less than a diameter of the proximal portion, an outer surface of the distal tip section between the proximal portion and the distal portion being curved or otherwise contoured.

13. The suction catheter of claim 1, wherein the open funnel-shaped distal mouth is collapsible to reduce or remove a flow restriction in the blood vessel during or after a procedure.

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