Collection systems and methods

Abstract

To provide a catheter having a funnel-like trap that is highly effective in trapping and retrieving brain emboli / thrombi.SOLUTION: A catheter system includes: an inner tube 14 movable within an outer tube 12; and a funnel-shaped sleeve 16 attached to the inner tube and configured for transitioning between a collapsed state when sequestered within the outer tube and an expanded state when advanced out of the outer tube.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The present invention relates to a catheter having a funnel-shaped trap that is highly effective in capturing and retrieving cerebral emboli / thrombi. [Background technology]

[0002] Interventional procedures used to treat vascular lesions that are not easily accessible for surgical procedures have continued to increase in recent years.

[0003] Such interventional procedures are particularly advantageous when used to treat lesions located in small, remote blood vessels, such as those in the brain.

[0004] Cerebral embolism is a vascular disorder caused when a material, typically a blood clot, travels and blocks a blood vessel supplying brain tissue.

[0005] One conventional technique for retrieving cerebral emboli involves the use of a retrieval catheter having a funnel-shaped trap that is used to capture and retrieve the emboli.

[0006] While such retrieval devices are effective in retrieving small clots, retrieval of larger clots can cause the clot to fragment, releasing potentially harmful clot particles into the bloodstream.

[0007] Thus, there remains room for improvement in clot retrieval systems, particularly the clot association and retraction capabilities of such systems. Summary of the Invention

[0008] According to one aspect of the present invention, there is provided a catheter system for retrieving material from a biological blood vessel, the catheter system comprising: an inner tube movable within an outer tube; a funnel-shaped sleeve attached to the inner tube and configured to transition between a collapsed state when isolated within the outer tube and an expanded state when advanced out of the outer tube; and a mechanism or indicator for enabling a user to advance a predetermined length of a portion of the sleeve out of the outer tube.

[0009] According to an embodiment of the present invention, the mechanism is a trigger for causing the advancement of the portion.

[0010] According to an embodiment of the present invention, the indicator includes markings to indicate advancement of the portion.

[0011] According to an embodiment of the present invention, the sleeve is a braided sleeve.

[0012] According to an embodiment of the present invention, the braided sleeve decreases in length when expanded.

[0013] According to an embodiment of the present invention, the braided sleeve comprises a cover.

[0014] According to an embodiment of the present invention, the cover is made from polyurethane, TPU, PTFE or silicone.

[0015] In accordance with an embodiment of the present invention, the catheter system further comprises a conduit for applying suction within the braided sleeve.

[0016] According to an embodiment of the present invention, the catheter system further comprises a vacuum source in communication with the conduit.

[0017] According to an embodiment of the present invention, a portion of the sleeve of a predetermined length forms a cone when advanced out of the outer tube.

[0018] According to an embodiment of the present invention, the distal opening of the sleeve includes a closure mechanism.

[0019] According to an embodiment of the present invention, the closure mechanism comprises a pull wire.

[0020] According to an embodiment of the present invention, the pull wire pinches the distal opening closed.

[0021] According to an embodiment of the present invention, the pull wire is positioned to allow separation of the substance from the wall of the funnel-shaped sleeve.

[0022] According to an embodiment of the present invention, the distal end of the sleeve is tapered so that the opening of the sleeve forms a tilted oval when expanded.

[0023] According to an embodiment of the present invention, the funnel-shaped sleeve comprises a radiopaque marker band.

[0024] According to an embodiment of the present invention, the braided sleeve comprises a wire loop at the distal end.

[0025] According to an embodiment of the present invention, the cover comprises a hydrophobic coating.

[0026] According to an embodiment of the present invention, the catheter system further comprises a conduit for injecting a dye.

[0027] According to an embodiment of the present invention, the catheter system further comprises at least one sensor for identifying the presence of a substance within the funnel-shaped sleeve.

[0028] According to an embodiment of the present invention, a first sensor of the at least one sensor is disposed in a proximal region of the funnel-shaped sleeve.

[0029] According to an embodiment of the present invention, a second of the at least one sensor is disposed in a distal region of the funnel-shaped sleeve.

[0030] In accordance with an embodiment of the present invention, the catheter system further comprises a plurality of flexible arms disposed within and attached to the funnel-shaped sleeve.

[0031] According to an embodiment of the present invention, the funnel sleeve has an hourglass shape when fully deployed.

[0032] According to another aspect of the present invention, there is provided a method for retrieving material from a biological vessel, the method including the steps of partially advancing a funnel-shaped sleeve out of a tube of a catheter positioned within the biological vessel to form a cone of predetermined length within the biological vessel, aspirating material within the biological vessel into the cone, and further advancing the funnel-shaped sleeve out of the tube and applying suction to capture the material within the funnel-shaped sleeve.

[0033] According to an embodiment of the present invention, the aspirating step is performed while advancing the catheter in the direction of the substance.

[0034] According to an embodiment of the present invention, the method further comprises closing the distal end of the funnel-shaped sleeve.

[0035] According to an embodiment of the present invention, the catheter is advanced through the biological vessel after partial deployment.

[0036] According to another aspect of the present invention, there is provided a catheter system for retrieving a substance from a biological blood vessel, the catheter system comprising: an inner tube movable within an outer tube; a funnel-shaped sleeve attached to the inner tube and configured to transition between a collapsed state when isolated within the outer tube and an expanded state when advanced out of the outer tube; and a plurality of flexible arms disposed within and attached to the funnel-shaped sleeve, the plurality of flexible arms configured to allow the substance to enter the funnel-shaped sleeve while preventing the substance from being expelled from the funnel-shaped sleeve.

[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used to practice or test the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, shall prevail. Furthermore, the materials, methods, and examples are merely illustrative and are not intended to be limiting.

[0038] The present invention is described herein by way of example only, with reference to the accompanying drawings. With particular reference now to the drawings in detail, it is emphasized that the details shown are by way of example and are solely for the purpose of illustrative description of preferred embodiments of the invention, presented to provide what is believed to be the most useful and readily understood explanation of the principles and conceptual aspects of the invention. In this regard, no attempt has been made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, and the description, taken together with the drawings, will make apparent to those skilled in the art how several forms of the invention may be embodied in practice. [Brief explanation of the drawings]

[0039] [Figure 1] Figures 1A-G show embodiments of the catheter system including a shovel-shaped funnel (Figures 1A, D-G), a standard funnel (Figure 1B), a trigger release handle (Figures 1A-B), and a handle with markings (Figure 1C). [Figure 2] Figures 2A-C show the two-stage deployment of the shovel funnel catheter configuration. Figures 2D-F show the shovel configuration in more detail, showing the leaflets formed from the wire loops. [Figure 3] 3A-C show a two-stage deployment of a standard funnel catheter configuration. [Figure 4] Figures 4A-C show clot capture using a shovel funnel catheter configuration, and Figures 4D-F show clot capture using a shovel funnel catheter configuration with flexible arms. [Figure 5]5A-C show clot capture using a standard funnel catheter configuration. [Figure 6] 6A-B show the trigger handle (FIG. 6A) or markings (FIG. 6B) used for partial deployment of a shovel or standard funnel. [Figure 7] 7A-C are fluoroscopic images of clot capture in a porcine model using the present catheter system with a standard funnel. [Figure 8] Figures 8A-B are fluoroscopic images of clot capture in a porcine model using the present catheter system equipped with a shovel funnel, and Figure 8C is an image of clot material retrieved by the procedure shown in Figures 8A-B. [Figure 9] 9A-B show a crusher 24 for crushing trapped thrombus. DETAILED DESCRIPTION OF THE INVENTION

[0040] The present invention is a catheter system and method that can be used to retrieve material / objects, such as emboli, from biological vessels, such as blood vessels.

[0041] The principles and operation of the present invention may be better understood with reference to the drawings and accompanying descriptions.

[0042] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or illustrated by way of example. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0043] Mechanical thrombectomy devices that utilize a trap to retrieve clot material are known in the art. Such traps can include a closable distal opening to retain the retrieved clot within the sleeve while minimizing release of the clot or fragments from the trap when withdrawn from the vasculature.

[0044] In a previously filed patent application (WO2019064306), the inventors disclosed a unique trap closure mechanism that substantially enhanced the recovery of the entire clot. In reducing the present invention to practice, the inventors set out to improve clot-trapping performance, especially in the case of large clots.

[0045] Thus, in accordance with one aspect of the present invention, there is provided a catheter system for retrieving a substance or object from a biological vessel.

[0046] As used herein, the term "material" refers to biological material such as that which characterizes a thrombus / embolus, while the term "object" refers to an implant such as a stent, stent graft, or the like.

[0047] The system can be used to access and treat any biological vessel, examples include vessels of the circulatory system (e.g., arteries, veins, lymphatic vessels), vessels of the urinary tract (e.g., urethra, ureters), and vessels of the lymphatic system.

[0048] The system of the present invention includes a funnel-shaped sleeve configured to transition between a collapsed state and an expanded state. When in the expanded state, the funnel-shaped sleeve is shaped like a funnel, tapering in diameter from the distal end to the proximal end. The funnel may be circular and perpendicular to the longitudinal axis of the catheter (also referred to herein as a "standard configuration"), or oval and tilted / angled relative to the longitudinal axis of the catheter (also referred to herein as a "shovel configuration"), with a lumen accessible through a distal opening.

[0049] When collapsed, the funnel-shaped sleeve becomes a narrow cylinder with a small lumen (large enough to pass a guidewire and / or microcatheter through). The funnel-shaped sleeve is self-expandable, where at least a portion of it self-expands to a final diameter limited by the diameter of the vessel (and the extent of deployment from the braided structure and catheter sheath).

[0050] According to one embodiment of the present invention, the funnel-shaped sleeve can be fabricated from metal (e.g., stainless steel or nitinol) or polymer (e.g., PTFE) wires braided in alternating helical and counter-helical directions. The braid can be covered (fully or partially) with a polymer such as TPU or polyurethane to allow for the application of a vacuum to the interior volume of the funnel-shaped sleeve.

[0051] The wire diameter may range from 0.02 to 0.25 mm, while the braid angle between wires may range from 60 to 140 degrees. Funnel-shaped sleeves can be fabricated using an appropriately sized mandrel by winding wires in an alternating helical pattern. For example, a single wire can be looped, and the tail of the loop can be wrapped in a helical pattern around the mandrel to form a crisscross pattern for each wire (1 x 1 pattern) or a crisscross pattern for every two wires (2 x 1 pattern) along the length of the mandrel. Several wires (12 to 64) can be used to form the braided structure. A braided structure with the same pattern but with a smaller diameter (Figure 1G) can be advantageous in some configurations because it increases the radial force of the funnel, thereby preventing collapse under suction. Examples of such braids are provided in WO2019064306. The funnel-shaped sleeve can be equipped with a wire loop at its distal end (surrounding the opening of the expanded funnel-shaped sleeve). The wire loops provide axial support and form leaflets that reduce braid compression when the funnel-shaped sleeve contacts the clot (thus minimizing the accordion effect that can occur when the braided structure presses against the clot). The wire loops also form soft tips that minimize vessel trauma during deployment. During aspiration, these wire leaflets collapse around and encase the clot without causing collapse of the braided structure.

[0052] The parameters and dimensions of the catheter and funnel sleeve vary depending on the application and type of vessel. When used for ischemic stroke in intracranial arteries, the size of the target artery can vary between 2.5 and 4.5 mm. The diameter of the funnel sleeve must be at least slightly larger than the diameter of the vessel to stop blood flow, and therefore ranges from 2 to 7 mm. The length of the funnel sleeve can be long enough to support the acceptance of a long blood clot within the lumen, but short enough to allow the funnel sleeve to be deployed by pushing it out of the catheter's outer tube or by retracting the sheath.

[0053] The system also includes a catheter for delivering the funnel-shaped sleeve into a blood vessel. According to one embodiment of the present invention, the funnel-shaped sleeve is attached to the distal end of the catheter inner tube (shaft) and may be covered by a removable sheath (outer tube) when in a collapsed configuration. Removal of the sheath (pulling proximally) allows the funnel-shaped sleeve to be deployed.

[0054] In another embodiment of the invention, the funnel-shaped sleeve is captured in a folded state within the lumen of the outer tube of the catheter and pushed for deployment through an inner tube attached to the proximal end of the funnel-shaped sleeve.

[0055] The catheter system can also include a suction source (e.g., syringe, pump) that can apply suction to the lumen (internal volume) of the funnel-shaped sleeve through a dedicated conduit that fluidly connects the suction source to the lumen of the funnel-shaped sleeve. The inner tube of the catheter can also function as a fluid conduit.

[0056] Experiments conducted by the inventors have revealed that when suction is applied to the lumen of the funnel-shaped sleeve, the distal opening of the fully extended funnel-shaped sleeve may occasionally become blocked by a large thrombus, which may cause the funnel-shaped sleeve to collapse upon suction.

[0057] The inventors have discovered that partially deploying the funnel-shaped sleeve so that a 2-8 mm long cone extends from the catheter or is uncovered by a sheath substantially improves the system's ability to collect thrombus material without occlusion or collapse. Therefore, the inventors have devised an approach in which the cone portion of the funnel-shaped sleeve is deployed first (at or advanced to the thrombus), the thrombus engages and is aspirated, and then the remainder of the funnel-shaped sleeve is gradually deployed while maintaining suction to completely aspirate and capture the thrombus.

[0058] With this approach, the system aspirates the thrombus, increasing the volume of the funnel as it sucks in the thrombus.

[0059] To enable such functionality, the catheter system includes a mechanism or indicator that allows for partial deployment of the funnel sleeve. The mechanism can include a trigger for precise partial deployment of the funnel sleeve, or an indicator with markings that allows the user to deploy a specific length of the funnel sleeve.

[0060] Referring now to the drawings, FIGS. 1A-D show a catheter system of the present invention, hereinafter referred to as system 10.

[0061] The system 10 includes a catheter shaft with an outer tube 12 surrounding an inner tube 14. The inner tube 14 is attached to a funnel-shaped sleeve 16 (shown expanded in FIGS. 1A-1C) that is used to capture (within its lumen) and retrieve material or objects from a biological vessel (e.g., an artery). The funnel-shaped sleeve 16 includes a distal opening 34 and a lumen 33 and can be one of two types: a shovel-shaped, funnel-shaped sleeve 16 (FIGS. 1A, 1C, 1D) or a standard funnel-shaped sleeve 16 (FIG. 1B).

[0062] The inner tube 14 may be an elongated, hollow tube selected for its length, diameter, and flexibility appropriate for the intended treatment site. Different anatomical sites require inner tubes 14 with different stiffness and axial flexibility. Inner tubes 14 with variable stiffness and axial flexibility along the shaft length are well known in the art and may be braided or coiled, including an inner coating of a low-friction material such as PTFE, a metal braid or coil on the inner layer, and an outer polymer layer (jacket) such as PEBAX or polyamide composites of various durometer ratings. Such tubes are commonly used for delivery to tortuous or intracranial vasculature.

[0063] The outer tube 12 may be an elongated hollow tube that can slide over the inner tube 14. The length of the inner tube 14 may be shorter than the length of the inner tube 14, allowing the outer tube 12 to be pulled back for partial and full deployment of the funnel-shaped sleeve 16.

[0064] The outer tube 12 is selected for a length, diameter, and flexibility appropriate for the intended treatment site. The desired high distal flexibility and tracking performance are achieved by selecting a soft jacket and metal coil design. The outer tube 12 can have different stiffness and axial flexibility, as well as proximal stiffness and pushability, for delivery to tortuous anatomical structures. Tubes with variable stiffness and axial flexibility along their length are well known in the art. Such tubes can be braided or coiled and include an inner polymer layer with a low-friction layer (e.g., PTFE), metal braids and coils in different sections covering the inner layer, and an outer polymer layer (jacket) such as PEBAX, polyurethane, or polyamide composites with various durometer ratings.

[0065] The outer diameter of the inner tube 14 may be 0.5 to 4 mm (e.g., 1.5 mm), while the inner diameter of the inner tube 14 (which can function as a suction conduit) may be 0.3 to 3.5 mm. A wire lumen (for closure) may be separate from the inner lumen and may be 0.03 to 0.3 mm in diameter (which can be positioned in the wall of the inner tube 14). The length of the inner tube 14 may be anywhere between 50 and 150 cm and is selected depending on the target vessel and the area to be treated.

[0066] The outer diameter of the outer tube 12 may be 1 to 6 mm, while the inner diameter of the outer tube 12 (which houses the inner tube 14) may be 0.8 to 5.5 mm. The length of the outer tube 12 may be anywhere between 45 and 145 cm, and is selected depending on the target vessel and the area to be treated.

[0067] The funnel-shaped sleeve 16 may be 5-80 mm long, tapering from 1-20 mm (distal) to 0.3-18 mm (proximal) in diameter when fully deployed, and 10-160 mm when isolated within the outer tube 12. The funnel-shaped sleeve 16 (standard or shovel) may alternatively have an hourglass shape when deployed (Figure 1D). The hourglass shape has the advantage that the difference in diameter in the two regions of the funnel-shaped sleeve 16 (marked proximal, distal, and R1 and R2, respectively) creates a pressure difference between the funnel sections (proximal and distal) via Bernoulli's principle, thus helping to advance material toward the proximal region (R1) of the funnel. Another advantage is that the proximal region (R1) can capture and retain thrombus, preventing its release due to its smaller diameter (Figure 1F) (it collapses on material).

[0068] The hourglass shape of the funnel sleeve 16 (Figure 1G) has the advantage that the PPI (pitch per inch) increases in the narrowing region (e.g., transition from R2 to R1), which increases the stiffness of the funnel and therefore prevents collapse under suction.

[0069] The funnel-shaped sleeve 16 can be deployed by pulling back (proximally) on the outer tube 12 using a handle 18 attached to the outer tube 12 (FIG. 1A) or by pushing the inner tube 14 (distally) relative to the handle 18. The markings 20 can be used to determine the length of the deployed funnel-shaped sleeve 16. Such markings can be used to partially deploy the funnel-shaped sleeve 16 to form a cone-like shape of a predetermined length (FIGS. 2B, 3B).

[0070] 6B shows in more detail the handle 18, which can be moved with the outer tube 12 to partially and then fully deploy the funnel-shaped sleeve 16. The handle 18 includes a button 19 for releasing / locking movement of the outer tube 12 relative to the inner tube 14. Markings 20 on the inner tube 14 indicate partial (one or more stages) and full deployment of the funnel-shaped sleeve 16.

[0071] The system 10 may also include an actuator 22 for closing the funnel-shaped sleeve 16, for example, after capturing a thrombus. Such an actuator may include a mechanism for pulling a wire extending from the actuator 22 through the inner tube 14 to the distal opening 34 of the funnel-shaped sleeve 16. When pulled, such a wire may cinch the funnel-shaped sleeve 16 closed.

[0072] The pull wire extends from the proximal end through the inner catheter (eg, sidewall conduit), through the lumen of the funnel-shaped sleeve (in a helical pattern), and is attached to some or all of the wire loop that forms the distal end 31 .

[0073] Closure can be achieved by clamping (e.g., purse-string suture) or by deflection (in the shovel configuration) by pulling the distal extension toward the base of the shovel. Alternatively, the shovel tip can be tilted downward 10-30 degrees and the closure wire can be pulled upward, thereby changing the height of the shovel, detaching the clot from the vessel wall.

[0074] FIG. 1B shows a handle 23 equipped with a trigger 26 and a mechanism for partially deploying the funnel-shaped sleeve 16 (as shown in FIGS. 2B and 3B). This mechanism retracts the outer tube 12 a measured distance upon actuation of the trigger 26. Alternatively, the trigger 26 may be a slider that can be moved to an indentation or marking. The slider configuration of the handle 23 is shown in more detail in FIG. 6A. The trigger 26 is a slider button that can be moved proximally-distal along the housing 27. Such movement partially pulls the outer tube 12 proximally, which then fully uncovers and deploys the funnel-shaped sleeve 16. The indentation in the housing 27 stops the slider button at preset positions corresponding to the first partial deployment (cone-like shape), second and optional third partial deployments, and full deployment.

[0075] System 10 may also include a suction source attached to inner tube 14 via port 35. Such a suction source may be a syringe 28 (FIG. 1C) or a pump that applies a suction pressure of -2 to -12 psi.

[0076] 2A-2C and 3A-C illustrate the deployment of a shovel-shaped (FIGS. 2A-2C) or standard (FIGS. 3A-3C) funnel-shaped sleeve 16 from an outer tube 12. As described hereinabove, the funnel-shaped sleeve 16 deploys in stages, with the first stage being partially deployed to form a cone-like shape. Such deployment can be accomplished by retracting the outer tube 12 or pushing out the inner tube 14, as described hereinabove.

[0077] In the shovel configuration, partial deployment (eg, the tip portion) can be used to facilitate navigation through tortuous vessels.

[0078] The shovel configuration of the funnel-shaped sleeve 16 is shown in more detail in Figures 2D-E.

[0079] In the embodiment shown in these figures, funnel-shaped sleeve 16 is braided (and optionally covered) with distal wire loops 17 that form leaflets that extend distally to a distal end 31 that is approximately 25%-75% of the circumference of funnel-shaped sleeve 16 and is 1-3 mm longer. The resulting distal end 31 is beveled at an angle (B) that can be 30-80 degrees.

[0080] The wire loop 17 can also be angled outward (flared, Figure 2D) at 120-170 degrees (over most or all of its circumference) so that the distal end 31 of the funnel-shaped sleeve 16, which defines the opening 34, has a larger diameter (15-60% larger) than the diameter of the lumen of the funnel-shaped sleeve 16 (A). This enhances the ability of the leaflets at the distal end 31 to suction the clot and form a seal between the distal end 31 of the funnel-shaped sleeve 16 and the vessel wall. This results in higher suction force, allowing for smoother clot entry into the funnel-shaped sleeve 16 and reducing the likelihood of arterial and funnel-shaped sleeve collapse.

[0081] 4A-C and 5A-C show the gradual capture of a thrombus 30 lodged within a blood vessel 32. FIG.

[0082] In the first step (FIGS. 4A, 5A), the system 10 is positioned away from or adjacent to the thrombus 30 using standard over-the-wire percutaneous access techniques (a wire is placed through the inner tube 14). The funnel-shaped sleeve 16 is then partially deployed using the trigger 26 or marking 20, advancing the distal opening 34 of the funnel-shaped sleeve 16 and positioning it against the thrombus 30 (FIGS. 4B, 5B). Suction is then applied through the inner tube 14 to partially internalize / engage the thrombus 30. A small amount of blood is slowly drawn into the syringe, indicating engagement of the thrombus.

[0083] Next, while maintaining suction, the funnel-shaped sleeve 16 is extended outward, thereby fully entrapping the thrombus 30. Once fully entrapped, the distal opening 34 of the funnel-shaped sleeve 16 is closed (e.g., with a pull wire). The system 10, along with the thrombus 30, can then be retrieved outside the body.

[0084] Figures 4D-F show capture using a standard funnel-shaped sleeve 16 with a capture / closure mechanism comprising flexible arms 21 at the distal portion of the funnel-shaped sleeve 16. Arms 21 are attached to (or formed with) the braided material of the funnel-shaped sleeve 16 and protrude distally at an angle of 16-25° away from the centerline of the funnel-shaped sleeve 16. As material (thrombus) advances toward the opening of the funnel-shaped sleeve 16 (Figure 4D), it pushes arms 21 outward (Figure 4E), thereby allowing the material to move into the funnel-shaped sleeve 16. In this respect, arms 21 function as a flexible trapdoor. Once material is within the proximal portion of the funnel-shaped sleeve, movement toward the distal end pushes arms 21, effectively blocking the distal opening and preventing release of the material (Figure 4F).

[0085] The funnel-shaped sleeve 16 and outer tube 12 and / or inner tube 14 may include radiopaque markers 41 (FIG. 2F) to indicate under fluoroscopy the funnel opening and the distance of the distal end 31 from the site of thrombus or occlusion. The radiopaque markers 41 may be, for example, three to six gold dots placed on the braided wire near or at the distal end 31 near the periphery. The distance between the imaged radiopaque markers can be used to indicate the extent of the opening of the funnel-shaped sleeve 16 within the vessel.

[0086] The funnel-shaped sleeve 16 may also include a sensor or sensor array 43 (at the proximal and distal ends) for detecting the presence of a substance within the lumen. The sensor 43 may be an impedance sensor such as that described in U.S. Patent Application Publication No. 20190159684.

[0087] The base (proximal) sensor 43 can be used to determine when suction can be stopped as material reaches the tapered base portion of the funnel-shaped sleeve 16. The tip (distal) sensor 43 can be used to determine if material is at the opening of the funnel-shaped sleeve 16 and may prevent closure.

[0088] The system 10 may also include a pulverizer 24 (FIGS. 9A-9B) for pulverizing the trapped thrombus. The pulverizer 24 may be introduced into the funnel-shaped sleeve 16 through the inner tube 14 (FIG. 9A) and may include a deployable cutter 25 that may include one or more arcuate blades that, upon rotation, pulverize the thrombus material, allowing it to be subsequently collected through the inner tube 14.

[0089] As used herein, the term "about" refers to ±10%.

[0090] Additional objects, advantages, and novel features of this invention will become apparent to those skilled in the art upon examination of the following examples thereof, which are not intended to be limiting. [Example]

[0091] Reference is now made to the following examples, which together with the above descriptions, illustrate the invention in a non limiting sense.

[0092] Animal testing A prototype of this system, equipped with either a standard or shovel funnel, was tested in a 60 kg female pig. A clot was generated from the pig's own blood to generate a whole-blood clot. The clot was then injected into the target site using a 6 Fr sheath, and angiography was performed to confirm vascular occlusion. Using a femoral access site, the over-the-wire and microcatheter of this system was guided to the occlusion site within the vessel, with the funnel folded within the catheter sheath (outer tube). The tip of the funnel and the marker band at the tip of the outer catheter, equipped with a radiopaque marker, were visible under fluoroscopy during guidance (Figure 7A).

[0093] The distal tip of the catheter was positioned a few millimeters from the clot, and the microcatheter and guidewire were removed. The funnel was advanced to the distal end of the outer tube, which was then retracted 2-3 mm, partially deploying the funnel to form a cone (Figure 7B). Suction was applied to pull the outer tube while simultaneously pushing the inner tube attached to the funnel forward to fully deploy the funnel (Figure 7C). The pull wire was used to close the distal opening of the funnel and retract it into the outer tube. The system was then removed along with the clot trapped within the funnel.

[0094] A second study was conducted in a 60 kg female pig using a prototype of the system with a shovel-shaped funnel. A femoral access site was used to guide the system's over-the-wire and microcatheter to the occlusion site within the vessel, with the funnel folded into the catheter sheath.

[0095] The distal tip of the catheter was positioned several millimeters from the clot (indicated by a contrast border on the angiogram), and the microcatheter and guidewire were removed (Figure 8A). The funnel was advanced to the distal end of the outer tube, which was then retracted 2-3 mm, partially deploying the funnel to form a cone (Figure 8B). Suction was applied to pull the outer tube, while simultaneously pushing the inner tube attached to the funnel forward to fully deploy the funnel (Figure 8C). The pull wire was used to close the distal opening of the funnel and retract it into the outer tube. The system was then removed along with the clot trapped within the funnel.

[0096] It will be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0097] While the present invention has been described in connection with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of a reference in this application should not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. A system for withdrawing a substance from a biological blood vessel, comprising: an outer tube movable through a biological blood vessel toward the substance; a sleeve at a distal portion of the system having an inner tube and an opening at a distal end, the sleeve being formed from a plurality of wires braided and covered with a polymer; Each of the plurality of wires extending spirally distally along the sleeve; are wound back at the distal ends to form respective distal end loops; and a spiral extending from the distal end loop back along the sleeve in a proximal direction; a plurality of circumferentially adjacent distal end loops are enlarged relative to the other distal end loops to form distally extending leaflets at the distal ends on one side of the opening; the sleeve is configured to transition between (i) a collapsed state when isolated within the outer tube and (ii) an expanded state when advanced out of the outer tube; The proximal portion of the sleeve is provided with a handle having a suction port through which suction is applied to the inner tube of the sleeve to draw material into the inner tube of the sleeve.

2. The system of claim 1 , wherein the leaflets are shovel-shaped distal extensions.

3. The system of claim 1 , wherein the leaflets extend 25% to 75% of the circumference of the sleeve distally for 1 to 3 mm.

4. The system of claim 1 , wherein the distal end of the sleeve is beveled at an angle of between 30 and 80 degrees.

5. The system of claim 1 , further comprising a pull wire closure mechanism for pinching closed the opening.

6. The system of claim 1 , further comprising a plurality of flexible arms disposed within and attached to the sleeve.

7. The system of claim 1 , wherein the sleeve has an hourglass shape when fully deployed.

8. The system of claim 1 , further comprising a device for softening material within the inner tube of the sleeve.

9. The system of claim 1 , further comprising a mechanism or indicator for allowing a user to advance a portion of the sleeve a predetermined length out of the outer tube.

10. The system of claim 9 , wherein the mechanism is a trigger for causing the advancement of the portion.

11. The system of claim 9 , wherein the indicator includes markings to indicate the advancement of the portion.

12. The system of claim 1 , further comprising a sensor for determining the presence or absence of a substance at the opening in the sleeve.

13. The system of claim 12 , wherein the sensor is located in a distal region of the sleeve.

14. The system of claim 12 , wherein the sensor is located in a proximal region of the sleeve.

15. The system of claim 1 , wherein three circumferentially adjacent distal wire loops are splayed outward relative to the other distal wire loops to define distally extending leaflets.

16. The system of claim 1 , wherein when the sleeve is fully deployed, the diameter of the sleeve is narrower at a middle portion of the sleeve than at a proximal portion of the sleeve or a distal portion of the sleeve.

17. The system of claim 1 further comprising a conduit through which dye can be injected into the inner tube of the sleeve.

Images