Clot retrieval device with external sheath and internal catheter

Abstract

The invention is entitled "Clot Retrieval Device with External Sheath and Internal Catheter." The invention discloses a device for retrieving an obstruction in a blood vessel, the device can have an external sheath having a distal end, a proximal end, a proximal luer fitting surrounding the proximal end, and a lumen extending proximally of the distal end and terminating within the proximal luer fitting; and an internal funnel catheter within the external sheath, the internal funnel catheter including a deployed distal tip, a proximal end, a distal end at the distal tip, a proximal luer fitting surrounding the proximal end, and a lumen extending proximally of the distal end and terminating at the luer fitting. The external sheath and internal funnel catheter are telescopically movable relative to one another. In some examples, a slider mechanism or knob on one of the proximal luer fittings can be used to actuate the relative motion.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application 62 / 941366, filed November 27, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates generally to apparatus and methods for removing blockages from blood vessels during endovascular medical treatment. More specifically, this invention relates to a clot retrieval device comprising an outer sheath and an inner funnel catheter. Background Technology

[0004] In patients with conditions such as acute ischemic stroke (AIS), myocardial infarction (MI), and pulmonary embolism (PE), clot retrieval catheters and devices are frequently used in mechanical thrombectomy targeting endovascular interventions. Accessing the neurovascular bed using conventional techniques is particularly challenging because the target vessel is small in diameter, distal relative to the insertion site, and highly tortuous. Conventional devices are often too large, lack the deliverability and flexibility required for navigating tortuous vessels, are difficult to apply and use, or fail to effectively remove the clot upon delivery to the target site.

[0005] Delivering effective devices to the small, highly branched cerebral arterial system remains challenging, and conventional clot retrieval catheters have several drawbacks. First, the catheter itself must be small enough to avoid causing significant discomfort to the patient. The retrieval catheter must also be flexible enough to navigate the vascular system and withstand high strain, while also possessing axial stiffness to provide smooth advancement along the route. Once the target site is reached, the typical size of the object retrieved from the body is significantly larger than the catheter tip, making it more difficult to retrieve the object back to the tip. For example, tight, fibrin-rich clots are often difficult to extract because they tend to aggregate at the tip of conventional fixed-orifice catheters. Furthermore, this aggregation can lead to the shearing off of softer portions from the tighter areas of the clot.

[0006] Small diameter and fixed-end size are also less effective for aspiration required to remove blood and thrombus material during guided procedures. Aspiration must be strong enough that any fragmentation that may occur due to aspiration or the use of mechanical thrombectomy devices cannot migrate and block distal vessels. However, when aspirating with a fixed-end catheter, a significant portion of the aspiration flow ends up in the proximal vessel fluid at the catheter tip, where no clots are present. This significantly reduces aspiration efficiency, thereby decreasing the success rate of clot removal.

[0007] Any catheter design attempting to overcome these challenges with an extended distal tip or structure needs to possess the strength to grasp the clot and apply a stable radial force in the extended state. The same structure also needs sufficient flexibility and resilience to withstand the severe mechanical strain imposed when navigating a tortuous vascular system in a collapsed state.

[0008] Furthermore, other catheter designs pose challenges to operators because they require the management and relative positioning of individual catheters or other components without mechanisms to stabilize their positioning relative to each other or to facilitate the non-invasive delivery of components. This can lead to invasive or inaccurate deployment of catheters and / or devices at the target site.

[0009] The present invention is designed to provide an improved retrieval catheter that overcomes the above-mentioned defects. Summary of the Invention

[0010] The object of the present invention is to provide an apparatus and method that meets the aforementioned requirements. Therefore, it is desirable for a clot retrieval catheter device to have a large, expandable end for easy removal and retrieval of clots, while also having a collapsed state that is flat and sufficiently flexible for delivery to the target site. The device should also incorporate treatment management enhancements to existing designs to assist administrators in operating the device. According to the invention, a device with an external sheath is provided that facilitates the introduction of a microcatheter, guidewire, or any of many commercially available products into a target site within a vascular system. The external sheath may be one or both of a guiding catheter and an intermediate catheter. The external sheath may have a distal end, a proximal end, a proximal Luer connector including the proximal end, and an inner lumen extending proximally from the distal end and terminating within the proximal Luer connector. In some examples, at least a portion of the distal end may be surrounded by a flexible membrane.

[0011] An internal funnel-shaped conduit with a deployable distal end can be located within an outer sheath. The deployable distal end may have a support structure consisting of struts or braided mesh. The internal funnel-shaped conduit can be pre-loaded into the outer sheath before the device is applied to the target site.

[0012] The internal funnel catheter may have a proximal end, a distal end, a proximal Luer connector including the proximal end, and an inner lumen extending proximally at the distal end and terminating within the Luer connector. The internal funnel catheter may also have a quick-exchange shaft or guidewire extending proximally to the Luer connector.

[0013] The tip of the internal funnel catheter may be self-deploying and positioned at the distal end of the internal funnel catheter. The tip may have a collapsed delivery configuration and a radially deployed configuration, in which the tip is substantially tapered or funnel-shaped. The distal tip may be configured to self-deploy radially when there is no constraint distal to the distal end of the outer sheath. In the collapsed state, the tip may have a radial dimension smaller than the maximum radial dimension of the tip. In deployed state, the tip may radially widen outward to form an open distal orifice. In some examples, at least a portion of the tip may have a diameter larger than the diameter of the outer sheath. In the deployed state, the tip may contact and seal the inner wall of the vessel.

[0014] A large distal orifice offers improved performance compared to conventional fixed-orifice designs. Traditional fixed-orifice catheters can be obstructed by the accumulation of tight, fibrin-rich clots at the tip or by the shearing away of softer portions of the clot. Furthermore, when aspirating through a fixed-orifice catheter, a significant portion of the aspirated fluid is directed proximally to the tip, reducing the aspiration of clots. Additionally, when the diameter of the expandable tip is close to the diameter of the vessel, clot shearing at the catheter orifice is reduced, and the volume of fluid and clots distal to the tip is contained.

[0015] At least a portion of the end of the internal funnel conduit may have a membrane disposed therearound it. In some examples, the membrane may cover both the end and some or all of the outer sheath. For example, the membrane may be attached to the distal end of the outer sheath and radially unfolded by radial self-unfolding of the distal end. In another example, the membrane may be attached to both the inner diameter of the internal funnel conduit and the outer diameter of the outer sheath, such that the membrane is radially unfolded by radial self-unfolding of the distal end.

[0016] The tip can be constructed from sheet or tubular stainless steel or a superelastic shape memory alloy (such as nitinol). In another example, the tip can have a construction made of braided wire or strip. In yet another example, the tip can be a grid laser-cut from a hypotube. The radial dimension of the tip shape can be designed to contact the inner wall of the blood vessel circumferentially without trauma.

[0017] In one example, the distal end of the outer sheath can be delivered close to the target site. The proximal Luer connector of the outer sheath can be held in a fixed position to maintain the positioning of the distal end of the outer sheath relative to the target site. An internal funnel can be present within the lumen of the outer sheath. The proximal Luer connector of the internal funnel can be moved distally toward the proximal Luer connector of the outer sheath to advance the distal end of the internal funnel towards the target site. The proximal Luer connector of the internal funnel can also be moved proximally away from the proximal Luer connector of the outer sheath to retract the internal funnel away from the target site.

[0018] In some examples, the proximal Luer connector of the inner funnel conduit can be axially connected to the proximal Luer connector of the outer sheath. When connected, the proximal Luer connector of the outer sheath can be located distal to the proximal Luer connector of the funnel conduit. The connection between the Luer connectors can be accomplished via snap-fit ​​features, Luer connector locking threads, locking tabs, or other suitable engagement mechanisms.

[0019] The proximal Luer connector of the funnel conduit may include a mechanism for changing the longitudinal position of the inner funnel conduit relative to the outer sheath. In one example, the proximal Luer connector of the funnel conduit may include a sliding mechanism for telescopically moving the inner funnel conduit relative to a fixed position of the outer sheath. By moving the sliding mechanism distally on the proximal Luer connector of the funnel conduit, the funnel conduit can be deployed to extend through the distal end of the outer sheath.

[0020] Alternatively, the proximal Luer connector of the outer sheath may have a slider mechanism for telescopically moving the outer sheath relative to a fixed position of the inner funnel conduit. The retraction slider mechanism retracts the outer sheath body relative to the funnel conduit, thereby allowing the deployable end of the funnel conduit to be exposed and deployed in situ. In one example, the slider mechanism can deploy the inner funnel conduit using a pulley wire assembly in the funnel conduit Luer connector. Additionally, the slider can be advanced distally on the proximal Luer connector of the outer sheath to push the outer sheath back in to surround the distal end of the funnel conduit and restore the configuration of the deployable end of the funnel conduit to its collapsed state.

[0021] In some examples, the inner funnel guide can be removed from within the outer sheath by securing the position of the proximal Luer connector of the outer sheath and retracting the proximal Luer connector of the funnel guide. If the funnel guide is to be replaced after removal, a loading tool may be provided to assist in pushing the funnel guide back through the outer sheath. The loading tool may incorporate a split or semi-split design, allowing it to be peeled or detached from the inner funnel guide.

[0022] In another example, a slider mechanism in the proximal Luer connector of the retractable outer sheath causes the outer sheath to retract relative to the inner funnel conduit. When the outer sheath retracts, the deployable end is exposed and deployed just proximal to the target site.

[0023] The distal tip may have a collapsed delivery position axially located within the outer sheath during advancement of the obstruction into the blood vessel. In some examples, the distance between the distal end of the outer sheath and the distal end of the inner funnel catheter in the collapsed delivery position of the outer sheath may be close to zero, requiring minimal movement to deploy the inner funnel catheter. In another example, the distance between the distal end of the outer sheath and the distal end of the inner funnel catheter may be in the range of 1 mm to 100 mm to facilitate distal flexibility of the outer sheath. In a more specific example, the collapsed delivery position of the distal tip is approximately 20 mm to 50 mm proximal to the distal end of the outer sheath.

[0024] In another example, the mechanism for advancing or retracting the position of the outer sheath relative to the inner funnel conduit can be a knob. Angular rotation of the knob can be converted into linear movement of the outer sheath. By rotating the knob counterclockwise or clockwise, the position of the outer sheath can be advanced distally or retracted proximally relative to the position of the inner funnel conduit.

[0025] In some examples, the inner funnel guide Luer connector may include a port for connecting a syringe. A channel may be provided between the outer sheath Luer connector and the funnel guide Luer connector, allowing both the inner funnel guide and the outer sheath to be flushed simultaneously via fluid injected from a syringe connected to the port of the inner funnel guide.

[0026] In another example, a locking tab connects the proximal Luer connector of the inner funnel conduit to the proximal Luer connector of the outer sheath. The locking tab holds the outer sheath and inner funnel conduit together for advancement. Since the distance between the distal end of the outer conduit and the collapsing funnel is maintained throughout advancement, the locking tab can be removed before deploying the funnel conduit. After the locking tab has been removed, the proximal Luer connectors of the inner funnel conduit and the outer sheath can be connected via a connection mechanism. This connection mechanism may include a snap-fit ​​feature, a Luer connector locking thread, or other engagement mechanism. The proximal Luer connectors of the inner funnel conduit and the outer sheath can then be disconnected, and the proximal Luer connector of the outer sheath can be moved distally away from the proximal Luer connector of the inner funnel conduit to retract the inner funnel conduit into the outer sheath.

[0027] A method for removing occlusive obstructions from a blood vessel is also provided. This method may include some or all of the following steps and variations thereof, and these steps are listed in a non-specific order. The method may include the steps of: advancing an outer sheath into the vascular system, the outer sheath including a distal end, a proximal end, and a proximal Luer connector containing the proximal end; advancing an internal funnel catheter through the outer sheath until the deployable distal end of the internal funnel catheter extends distally to the distal end of the outer sheath and is positioned near the obstructive thrombus, the internal funnel catheter being telescopically movable within the outer sheath and including a proximal end, a distal end, and a proximal Luer connector containing the proximal end; capturing the thrombus in the orifice of the internal funnel catheter; and passing the internal funnel catheter with the captured thrombus through the vascular system and retrieving it from the patient.

[0028] Upon delivery to the target site, the deployable tip of the internal funnel catheter can be deployed radially self-expanding to contact the inner wall of the vessel. The contour of the tip can ablate against the vessel wall proximal to the target site for a non-invasive seal. This blocks vascular fluid proximal to the orifice and provides a large opening for easy clot reception. Therefore, the method may also include the step of coating the deployable distal tip with a membrane. Alternatively, this step may involve advancing the distal tip distally to deploy a membrane attached to the distal end of an outer sheath, or deploying a membrane connected to both the funnel catheter and the outer sheath.

[0029] In one example, the step of advancing the inner funnel guide through the outer sheath may include moving the proximal Luer connector of the inner funnel guide distally toward the proximal Luer connector of the outer sheath to advance the distal end of the inner funnel guide toward the target site. Alternatively, a locking mechanism may be used to hold the inner funnel guide and the outer sheath together for distal advancement. In some examples, the locking mechanism may be one of a locking tab, a snap-fit ​​feature, or a Luer connector locking thread.

[0030] The internal funnel conduit and the outer sheath can be moved telescopically relative to each other by utilizing a sliding mechanism or a knob. In one example, the proximal Luer connector of the internal funnel conduit may have a sliding mechanism for advancing or retracting the position of the funnel conduit relative to the outer sheath, and the method may further include the step of moving the sliding mechanism distally on the proximal Luer connector of the funnel conduit to deploy the distal end of the funnel conduit as an extension through the distal end of the outer sheath.

[0031] In another example, the proximal Luer connector of the outer sheath may have a slider mechanism for advancing or retracting the position of the outer sheath relative to the funnel mechanism, and the method may further include the step of retracting the slider mechanism proximally to expose the end of the inner funnel conduit and thus deploying the end of the inner funnel conduit through the distal end of the outer sheath.

[0032] In another example, the proximal Luer connector of the outer sheath may have a knob for advancing and retracting the position of the outer sheath relative to the inner funnel conduit, and the method may further include the step of rotating the knob to retract the outer sheath proximally relative to the inner funnel conduit.

[0033] The steps of capturing a thrombus in the clot and retrieving it into the mouth of the catheter may include using aspiration, a thrombectomy device, or other practices and medical devices known in the art.

[0034] In many cases, after retrieving some or all of the occlusive clot, contrast agent can be injected to allow for a more comprehensive assessment of vascular patency. If the obstruction remains in the vessel, additional passes can be made using an internal funnel catheter and / or clot retrieval device. Therefore, this method can also include a step of maintaining the position of the outer sheath at the target site while retrieving the internal funnel catheter. This ensures that access to the target site is not lost for subsequent retrieval attempts. Once adequate recanalization of the target vessel is observed, any remaining devices can then be removed from the patient.

[0035] To clean the outer sheath and inner funnel catheter between procedures or at the end of the procedure, the method may further include the following steps: simultaneously flushing both the outer sheath and the inner funnel catheter to remove aggregated or loose debris. Multiple channels may be created between the proximal Luer connector of the outer sheath and the proximal Luer connector of the inner funnel catheter to allow both to be flushed simultaneously.

[0036] Other aspects and features of this disclosure will become apparent to those skilled in the art after viewing the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0037] The above and other aspects of the invention will be further discussed with reference to the accompanying drawings, in which like numbers indicate the same structural elements and features in the various figures. The drawings are not necessarily drawn to scale; rather, the focus is on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the apparatus of the invention by way of example only and not by way of limitation. It is anticipated that those skilled in the art will be able to conceive of and combine elements from the various drawings to better meet the needs of the user.

[0038] Figure 1 This is an illustration of an apparatus having an outer sheath and an inner funnel conduit according to various aspects of the invention, wherein the inner funnel conduit has been deployed;

[0039] Figure 2 This is a closer view of an example of the end of an internal funnel conduit in a deployment position according to various aspects of the present invention;

[0040] Figures 3a to 3cThis is an illustration of a treatment sequence of an exemplary treatment device for retrieving clots according to various aspects of the present invention;

[0041] Figures 4a to 4c Another treatment sequence of an exemplary treatment device for retrieving clots according to various aspects of the present invention is shown;

[0042] Figures 5a to 5c This is a view of another treatment sequence of an exemplary treatment device for retrieving clots according to various aspects of the present invention;

[0043] Figures 6a to 6c Another treatment sequence is described in the exemplary treatment apparatus for retrieving clots according to various aspects of the present invention;

[0044] Figures 7a to 7c Another treatment sequence of an exemplary treatment device for retrieving clots according to various aspects of the present invention is shown;

[0045] Figures 8a to 8c Another exemplary therapeutic device having a membrane according to various aspects of the present invention is shown;

[0046] Figures 9a to 9b This is an illustration of another exemplary therapeutic device having a membrane according to various aspects of the present invention;

[0047] Figures 10a to 10b These are views of an exemplary therapeutic device with a membrane according to various aspects of the present invention; and

[0048] Figure 11 This is a flowchart outlining the method of using the apparatus according to various aspects of the present invention. Detailed Implementation

[0049] Specific examples of the invention will now be described in detail with reference to the accompanying drawings, wherein like reference numerals indicate functionally similar or identical elements.

[0050] Approaching various intravascular vessels (whether coronary, pulmonary, or cerebral) involves well-known surgical procedures and the use of many routinely available commercially available accessory products. These products, such as angiography materials, rotary valves, and guidewires, are widely used in laboratory and medical procedures. Their function and exact construction when used in conjunction with the systems and methods of the present invention described below are not described in detail.

[0051] See the attached diagram. Figure 1The present invention illustrates an apparatus 100 for removing occlusive clots from a patient's blood vessels. The apparatus 100 may have an outer sheath 102 that facilitates the introduction of a microcatheter, guidewire, or any of a number of commercially available products into a target site within the vascular system. The outer sheath 102 may be one or both of a guiding catheter and an intermediate catheter. The outer sheath 102 may have a distal end 102a, a proximal end 102b, a proximal Luer connector 106 including the proximal end 102b, and an inner lumen 102c extending proximally from the distal end 102a and terminating within the proximal Luer connector 106. In addition to introducing other devices, the inner lumen may guide aspiration from the proximal end 102a to the distal end 102b of the outer sheath 102. The outer sheath 102 may be positioned within the patient's vascular system such that the distal end 102a is close to the target occlusive clot.

[0052] System 100 may also have an internal funnel catheter 104 with an extended distal end 112. The internal funnel catheter 104 may be located within an outer sheath 102. In some examples, the internal funnel catheter is concentric with the outer sheath 102 and is configured to telescopably move within the outer sheath. The internal funnel catheter 104 may be preloaded into the outer sheath 102 before the device 100 is applied to the target site. Alternatively, the internal funnel catheter 104 may be inserted into the outer sheath 102 after the outer sheath 102 has been positioned within the patient's vascular system.

[0053] The internal funnel catheter may have a proximal end 104b, a distal end 104a, a proximal Luer connector 108 including the proximal end 104b, and a lumen 104c extending proximally from the distal end 104a and terminating within the Luer connector 108. The lumen may be defined by a tubular support (such as a polymer and / or braided structure) and may be configured to allow guidewires, microcatheters, stent retrieval devices, and other such devices to pass through it. The lumen may also guide aspiration from the proximal end 104b to the distal end 112 of the internal funnel catheter. The internal funnel catheter 104 may also have a quick-exchange shaft or guidewire extending proximally to the Luer connector 108 for manipulating and delivering the internal funnel catheter 104. Figure 2 The dimensions and configuration of the distal end 112 shown can be configured such that, when deployed at the target site, it unfolds to non-invasively contact the inner vessel wall, thereby providing the maximum possible opening for aspiration or otherwise removal and reception of clots. The unfolded end 112 can also provide flow retardation and prevent unwanted aspiration of blood proximal to the end 112.

[0054] The internal funnel catheter 104 can be manipulated independently of the outer sheath 102, and vice versa. The proximal segment of the internal funnel catheter 104 can have good thrust and trackability characteristics to aid in its advancement to the target location, while the more distal segment can have extremely high flexibility to navigate tortuous anatomical structures. Therefore, the internal funnel catheter 104 can have multiple designs or be manufactured from various materials to impart a reduced stiffness profile along its length, thereby minimizing insertion and retraction forces. Features that bias around certain planes or promote torsion to facilitate delivery to the target site may also be incorporated.

[0055] The internal funnel catheter 104 can be used in conjunction with a separate mechanical device (such as a thrombectomy device) for clot removal. The separate device can be any of a number of commercially available clot retrieval products. The mechanical device can be housed in a microcatheter movable relative to the internal funnel catheter 104. The microcatheter can be positioned within the lumen 104c of the internal funnel catheter. The proximal Luer connector 108 of the internal funnel catheter facilitates delivery of the microcatheter to the target site. The internal funnel catheter 104, microcatheter, and device can be delivered individually or simultaneously to the target site via the outer sheath 102. Once the target site is reached, the distal end 112 of the internal funnel catheter 104 can be deployed. The thrombectomy device can then be deployed from the microcatheter to engage and capture the occlusive clot while aspiration occurs through the deployed distal end 112 of the internal funnel catheter 104 and / or the outer sheath 102.

[0056] like Figure 2 As depicted, the distal end 112 may have a collapsed delivery configuration and a radially deployed configuration, in which the distal end presents a substantially conical or funnel shape. The distal end 112 may be composed of a plurality of struts 140. In the collapsed state, the distal end 112 may have a radial dimension smaller than the maximum radial dimension of the distal end. When deployed, the distal end 112 may initially extend distal to the outer sheath 102 and then radially widen outward, wherein at least a portion of the distal end presents a diameter larger than the diameter of the outer sheath 102. In the deployed state, the distal end 112 may contact and seal the inner wall of the blood vessel.

[0057] The tip 112 can be constructed from sheet or tubular stainless steel or a superelastic shape memory alloy (such as nitinol). Alternatively, the tip 112 can have a braided construction of strips or wires. The tip 112 can also be a grid laser-cut from a hypotube. The radial dimension of the tip 112 can be sized to contact the inner wall of the blood vessel without trauma. The funnel shape formed by the tip 112 upon unfolding improves aspiration efficiency, reduces friction, and decreases the risk of hooking onto the blood vessel opening or causing vascular trauma. The maximum radius of the tip 112 can be smaller, larger, or approximately the same as the diameter of the target blood vessel.

[0058] The device may also have a membrane 110 (not shown) arranged radially around at least a portion of the end 112. One or more identical or different membranes may also cover some or all of the longitudinal axis of the conduit.

[0059] exist Figure 3a In the diagram, the inner funnel conduit 104 is shown within the outer sheath 102, with the proximal Luer connector 108 of the inner funnel conduit located proximal to the proximal Luer connector 106 of the outer sheath. The inner funnel conduit 104 and the outer sheath 102, in this configuration, can be provided as separate components for use in conjunction with each other. Alternatively, the inner funnel conduit 104 and the outer sheath 102 can be provided in a pre-assembled state. The inner funnel conduit 104 can be placed within the outer sheath 102 before the device 100 is deployed to the target site. Figure 3a An internal funnel conduit 104 with an end 112 is shown in a collapsed configuration constrained within an outer sheath 102. In this figure, the internal funnel conduit 104 is pre-loaded in a collapsed configuration, but the internal funnel conduit 104 may also be pre-loaded in a deployment configuration.

[0060] Figure 3b A proximal Luer connector 108 of an internal funnel catheter 104 is depicted, which surrounds the proximal end 104b of the internal funnel catheter and moves distally toward the proximal Luer connector 106 of the outer sheath 102, while the proximal Luer connector 106 of the outer sheath remains in a fixed position. This distal movement causes the internal funnel catheter 104 to telescopically move toward the treatment site and beyond the distal end 102a of the outer sheath. When the internal funnel catheter 104 is no longer constrained by the outer sheath 102a, the deployed distal end 112 can be deployed to facilitate the removal of clots via aspiration and / or delivery via a microcatheter (not shown) of another medical device. The deployed funnel end 112 can be configured to self-size in a distally constricting vessel in a non-invasive manner as it is advanced distally toward the target treatment location.

[0061] The distal end provides a large distal orifice for aspirating the clot, and its size can be set to be nearly the same as or slightly larger in diameter than the target vessel. Therefore, the distal end 112 can seal against the vessel or form sufficient restriction such that when aspiration is applied, blood and clot distal to the orifice will be drawn into the internal funnel catheter 104 rather than into the blood proximal to the distal end. If the extended distal end 112 is not sealed, or if there is no other seal between the external or clot retrieval catheter and the inner wall of the vessel, aspiration applied to the clot may be ineffective because the less restricted flow proximal to the distal end will dominate.

[0062] Alternatively, in Figure 3bIn this configuration, as the proximal Luer connector 106 of the outer sheath moves proximally toward the proximal Luer connector 108 of the inner funnel catheter, the inner funnel catheter 104 can be held in a fixed position, thereby retracting the outer sheath 102 and exposing the inner funnel catheter 104 to deploy the extended distal end 112. This configuration is less invasive because it does not require further distal advancement of the deployed funnel and does not require fully extended distal advancement of the funnel through the blood vessel.

[0063] exist Figure 3c In this process, the proximal Luer connector 108 of the inner funnel conduit 104 moves proximally away from the static proximal Luer connector of the outer sheath 102, thereby causing the inner funnel conduit 104 to move proximally back into the outer sheath 102 and the deployable distal end 112 to be constrained back into its collapsed configuration. In cases where tight or fibrin-rich clots accumulate in the end, complete re-coating of the end may be impossible, and the outer sheath 102 and the inner funnel conduit 104 can be withdrawn sequentially.

[0064] Figures 4a to 4c An example of device 100 is depicted, wherein a sliding mechanism 114 is located on the proximal Luer connector 108 of the inner funnel conduit 104 to facilitate movement of the inner funnel conduit relative to the outer sheath 102. Figure 4a In this configuration, the proximal Luer connector 108 of the inner funnel catheter is connected to the proximal Luer connector 106 of the outer sheath. The proximal Luer connector 108 of the inner funnel catheter and the proximal Luer connector 106 of the outer sheath can be locked together for advancement through the vascular system before the device 100 is applied to the treatment site. The connection between the Luer connectors can be accomplished, for example, by a snap-fit ​​feature, Luer connector locking threads, locking tabs, or other suitable engagement mechanisms. In the connected configuration, the proximal Luer connector 106 of the outer sheath is located distal to the proximal Luer connector 108 of the funnel catheter. Figure 4a In the case of the internal funnel conduit 104, the deployable distal end 112 is in a collapsed form within the outer sheath 102 for delivery.

[0065] The sliding mechanism 114 of the proximal Luer connector 108 of the funnel conduit 104 can interact with the proximal end 104b of the inner funnel conduit to telescopically advance or retract the position of the funnel conduit relative to the outer sheath 102. Figure 4b In this context, the slider mechanism 114 is depicted as having moved distally on the proximal Luer joint 108 of the inner funnel conduit, thereby moving the inner funnel conduit 104 to extend the distal end 102a through the outer sheath and causing the distal end 112 to be deployed into the unfolded configuration.

[0066] like Figure 4cThe inner funnel catheter 104 can be withdrawn into the outer sheath 102 in such a manner that a retraction slider mechanism 114 holds the proximal Luer connector 106 of the outer sheath in place while the proximal Luer connector 108 of the inner funnel catheter is disassembled and retracted proximally. The inner funnel catheter 104 can be removed while the outer sheath 102 is held in place within the patient. If the inner funnel catheter 104 is removed, the outer sheath 102 can be used as an aspiration catheter or can maintain access to a target site for subsequent reinsertion of the inner funnel catheter 104 or other devices. For example, if a trapped clot obstructs the lumen 104a of the inner funnel catheter, the outer sheath can be held in place while the inner funnel catheter is cleaned.

[0067] At least one hemostatic valve (not shown) may be attached to the internal funnel catheter 104 or its Luer connector 108 and / or the outer sheath 102 and its Luer connector 106. The proximal Luer connector 106 of the outer sheath may also include a lateral Luer connector or port 106a for flushing. Additionally, if the internal funnel catheter is replaced after removal, a loading tool may be provided to assist in re-advancing the internal funnel catheter 104 through the outer sheath 102. The loading tool may incorporate a split or semi-split design, allowing it to be peeled or detached from the internal funnel catheter 104.

[0068] Figures 5a to 5c An example of device 100 is depicted, wherein a sliding mechanism 116 is located in or on the proximal Luer joint 106 of the outer sheath 102 to facilitate movement of the outer sheath relative to the inner funnel conduit 104. Figure 5a In this configuration, the proximal Luer connector 108 of the inner funnel catheter is connected to the proximal Luer connector 106 of the outer sheath. The proximal Luer connector 108 of the inner funnel catheter and the proximal Luer connector 106 of the outer sheath can be connected before the device 100 is advanced to the treatment site. As in other examples, this connection can be a snap-fit ​​feature, a Luer connector locking thread, a locking tab, or other engagement mechanism. In this configuration, the proximal Luer connector 106 of the outer sheath is located distal to the proximal Luer connector 108 of the funnel catheter. Figure 5a In the middle, the distal end 112 of the internal funnel conduit 104 is in a collapsed form within the outer sheath 102.

[0069] The sliding mechanism 116 of the proximal Luer connector 106 of the outer sheath 102 can advance or retract the position of the outer sheath relative to the inner funnel conduit 114. During delivery, the distal end 112 can be in a collapsed delivery position relative to the distal end 102a of the outer sheath 102. In one example, the distance D between the distal end 102a of the outer sheath and the distal end 104a of the inner funnel conduit can be close to zero, requiring minimal movement to deploy the inner funnel conduit. In another example, the distance D between the distal end of the outer sheath and the distal end of the inner funnel conduit in the delivery position can be approximately 1 mm to 100 mm to maintain distal flexibility of the outer sheath. Alternatively, the distance between the distal end of the outer sheath and the distal end of the inner funnel conduit can be approximately 20 mm to 50 mm, such that flexibility of the outer sheath is maintained for this distance.

[0070] like Figure 5b As depicted, by retracting the slider mechanism 116 proximally on the proximal Luer connector 106 of the outer sheath, the distal end 112 of the inner funnel conduit 104 can be exposed outside the outer sheath 102 at the target side as the outer sheath moves proximally relative to the inner funnel conduit 104. The slider mechanism 116 can interact with a pulley and wire assembly or similar articulation mechanism in the funnel conduit Luer connector 108. The slider mechanism 116 can also be advanced distally on the proximal Luer connector 106 of the outer sheath to re-lock the distal end 104a of the funnel conduit and cause the distal end 112 of the inner funnel conduit 104 to collapse.

[0071] Figure 5b The configuration allows the internal funnel catheter 104 to be deployed in situ, which improves deployment accuracy relative to the target site and creates a more non-invasive vascular interaction because the extended end 112 is not advanced distally toward the target site.

[0072] Figure 5c The inner funnel conduit 104 can be withdrawn from the outer sheath 102 by holding the proximal Luer connector 106 of the outer sheath in place and removing and retracting the proximal Luer connector 108 of the inner funnel conduit. The inner funnel conduit 104 can be removed while the outer sheath 102 remains in place, allowing the outer sheath 102 to function as a suction conduit and maintaining access to the target site. The proximal Luer connector 106 of the outer sheath may also include a lateral Luer connector 106a for flushing.

[0073] Figures 6a to 6c An example of device 100 is depicted, wherein a knob 118 is located on the proximal Luer connector 106 of the outer sheath to facilitate movement of the outer sheath 102 relative to the inner funnel conduit 104. Figure 6aWhen the knob 118 is rotated, the knob interacts with the proximal end 102b of the outer sheath 102 to extend or retract the outer sheath distally or proximally relative to the inner funnel conduit 104 in a telescopic manner. It should be understood that a rotating Luer connector device can also be used on the Luer connector of the inner funnel conduit to extend or shorten its length relative to the outer sheath.

[0074] For devices involving a long stroke between the internal and external catheters, the use of the knob 118 mechanism minimizes the length of the Luer connector 106. The total length of the device 100 should be within the range of commonly available catheters, allowing it to be used with commonly available balloon guides, intermediate catheters, microcatheters, and similar devices. For example, for use with a balloon guide, the device 100 may have a length of approximately 80 cm to 100 cm. For use with an intermediate catheter, the device 100 may have a length of approximately 120 cm to 140 cm. For use with a microcatheter, the device 100 may have a length between 130 cm and 160 cm. Similarly, other lengths may be expected depending on the nature of the procedure.

[0075] The inner funnel guide Luer connector 108 may include a port for connecting a syringe or another fluid or vacuum source. Multiple channels may be provided between the outer sheath Luer connector 106 and the funnel guide Luer connector 108, allowing both the inner funnel guide 104 and the outer sheath 102 to be flushed simultaneously via fluid injected into the port of the inner funnel guide 104.

[0076] like Figure 6b As depicted, rotating the knob 118 retracts the outer sheath 102 to expose the inner funnel conduit 104 at the target location. The outer sheath 102 can be moved proximally relative to the inner funnel conduit 104 via the knob mechanism 118, thereby allowing deployment of the inner funnel conduit. The knob mechanism 118 can also be rotated in the opposite direction to re-enclose the distal end 104a of the funnel conduit and re-attach the extended end 112 of the inner funnel conduit 104.

[0077] Figure 6c The inner funnel conduit 104 can be withdrawn from the outer sheath 102 by holding the proximal Luer connector 106 of the outer sheath in place and removing and retracting the proximal Luer connector 108 of the inner funnel conduit. Similar to other examples, the inner funnel conduit 104 can be removed while the outer sheath 102 remains in place for use as a suction conduit and maintains access to the target site.

[0078] Figures 7a to 7c An example of device 100 is depicted, wherein a locking tab 134 is located between the proximal Luer connector 106 of the outer sheath 102 and the proximal Luer connector 108 of the inner funnel conduit 104. Figure 7b As depicted, a removable locking tab 134 is present. The proximal Luer connector 106 of the outer sheath is movable proximally toward the proximal Luer connector 108 of the inner funnel catheter to retract the position of the outer sheath 102 relative to the inner funnel catheter 104. The locking tab 134 allows the two catheters 102, 104 to remain static relative to each other during transport, sterilization, and advancement through the vascular bed. After the locking tab has been removed, the outer sheath and the inner funnel catheter are capable of translation relative to each other. A connection mechanism may be provided to allow the Luer connectors to be temporarily connected during the procedure. This connection mechanism may include, for example, Figure 7c The depicted snap-fit ​​feature 130, Luer connector locking thread, or other engagement mechanism. Once the clot is reached, the distal end 112 can be deployed as shown, and the snap-fit ​​feature 130 can lock the deployed internal funnel conduit 104 in place.

[0079] like Figure 7c As depicted, the proximal Luer connector 108 of the inner funnel catheter and the proximal Luer connector 106 of the outer sheath can then be disconnected by overcoming a snap-fit ​​force of 130. The inner funnel catheter 104 can then be withdrawn into the outer sheath 102 by holding the proximal Luer connector 106 of the outer sheath in a fixed position and removing and retracting the proximal Luer connector 108 of the inner funnel catheter. As in other examples, at least one hemostatic valve may be attached to the inner funnel catheter 104 or its Luer connector 108 and / or the outer sheath 102 or its Luer connector 106.

[0080] Figures 8a to 8c This is an illustration of an exemplary therapeutic device with a membrane according to various aspects of the present invention. In some examples, the end 112 may be covered by a membrane 110. When the end 112 is fully deployed, the struts of the end can radially stretch the membrane surface into a funnel-shaped profile with increased curvature.

[0081] Membrane 110 can take on a variety of different forms or configurations. Membrane 110 can be formed into a tubular profile using a highly elastic material, such that the unfolding of the tip 112 will provide sufficient radial force to stretch membrane 110 into the profile of tip 112 when unrestrained. Membrane 110 can be, for example, a low-modulus elastomer. The elastomer membrane 110 can form a gentle contact surface to seal against the vessel wall when tip 112 is deployed in the unfolded configuration. In another example, membrane 110 can be formed to include soft elastomer or gel ribs on its outer surface, thereby providing non-invasive contact with the vessel wall. This seal can achieve more efficient aspiration by concentrating aspiration distally and limiting the aspiration of clot-free fluid proximal to the tip into the catheter.

[0082] If the end 112 is cut from the thiocyanate tube, spaces, slots, or patterns can be laser-cut into the outer surface of the thiocyanate tube, and the membrane 110 can be reflowed or injection-molded into these spaces during manufacturing. Heat can be used to adhere the membrane 110 to the support 140 of the end 112. All factors such as immersion dwell time, substrate withdrawal speed, temperature, humidity, and cycle number can be modified to give the membrane 110 a desired and uniform profile. Alternatively, the loose or sagging membrane 110 can be placed above the opening of the end.

[0083] like Figure 8a As depicted, membrane 110 may be attached to the distal end 112 of the deployed membrane and may also be attached to some or all of the conduit shafts proximal to the distal end. The membrane may also be encased above the frame in the deployed state, such that it is compressed for delivery and returns to its initial shape upon deployment. Elastomeric materials or materials that do not exceed their elastic strain limits when collapsed into the external conduit may be used for membrane 110.

[0084] like Figure 8b As depicted, membrane 110 may enclose the unfolded end 112, such that membrane 100 can be stretched between the struts of end 112 during unfolding. Alternatively, as Figure 8c As depicted, the membrane 110 can be formed as a tube and flipped to fold distally from the interior of the end 112 and flipped around the end 112 to extend proximally along the outer surface of the end 112. Figure 8c The depicted configuration does not completely enclose the end 112 in a gap-filling manner, thus allowing the structure of the end 112 to unfold freely within the membrane cover 110. Therefore... Figure 8c The depicted membrane configuration reduces the strain required to deploy the membrane and the radial force required to deploy the end 112.

[0085] Figures 9a to 9b This is an illustration of another exemplary therapeutic device having a membrane according to various aspects of the present invention. Figure 9a In this configuration, membrane 110 can be attached to the distal end of the outer sheath 102a. The membrane may have a tapered or reduced outer diameter OD, which facilitates the non-invasive advancement of device 100 through the vascular system. According to... Figures 3a to 3c , Figures 4a to 4c , Figures 5a to 5c , Figures 6a to 6c or Figures 7a to 7c The operable device 100 can move the internal funnel conduit 104 distally relative to the outer sheath 102 or move the outer sheath 102 proximal to the internal funnel conduit 104 in any way that deploys the deployable end 112 of the internal funnel conduit just to the proximal side of the target site. Figure 9a Depicting the presentation Figures 5a to 5cA similar configuration is used, featuring an outer sheath mechanism with a slider 116. By utilizing the slider mechanism 116, the inner funnel conduit 104 can be moved distally to press into the membrane 110, or the outer sheath 102 can be moved proximally relative to the inner funnel conduit 104. When unrestrained, the end 112 opens into and unfolds into the membrane 110, subsequently causing the membrane 110 to unfold, as... Figure 9b As seen above, membrane 110 can be an elastomer or a drooping material.

[0086] Figures 10a to 10b This is an illustration of another exemplary therapeutic device having a membrane according to various aspects of the present invention. Figure 10a In this configuration, membrane 110 is attached to the distal end of outer sheath 102a and the inner surface of inner funnel conduit 104. Membrane 110 extends from the inner diameter ID of inner funnel conduit 104 and is folded around the outer diameter OD to connect to outer sheath 102. As in the previously described example, operable device 100 is capable of moving inner funnel conduit 104 distally relative to outer sheath 102 or moving outer sheath 102 proximally relative to inner funnel conduit 104 in any manner that deploys the deployable end 112 of inner funnel conduit. Figure 10a Depicting the presentation Figures 5a to 5c A similar configuration is used, featuring an outer sheath slider mechanism 116. When the inner funnel conduit 104 is advanced and / or the outer sheath is retracted, the membrane 110 moves and unfolds along with the end 112. Figure 10b In the configuration shown, the outer frame of the inner funnel conduit 104 is pressed against the inner surface of the outer sheath 102 rather than against the membrane, thereby reducing friction during delivery and deployment.

[0087] Figure 11 A flowchart outlining the method of using the device is depicted. The method may have some or all of the following steps and variations thereof, and these steps are listed in a non-specific order. Method 1100 may include the steps of: advancing an outer sheath into the vascular system, the outer sheath including a distal end, a proximal end, and a proximal Luer connector including the proximal end (1110); advancing an internal funnel catheter through the outer sheath until the deployable distal end of the internal funnel catheter extends distally to the distal end of the outer sheath and is deployed near the obstructive thrombus, the internal funnel catheter including a proximal end, a distal end, and a proximal Luer connector including the proximal end (1120); capturing the thrombus in the orifice of the internal funnel catheter (1130); and passing the internal funnel catheter with the captured thrombus through the vascular system and retrieving it from the patient (1140).

[0088] It should be understood that the outer sheath and the inner funnel catheter can be advanced to the target site together or separately. For example, the method may involve preloading the inner funnel catheter into the outer sheath. The system can then be flushed and advanced to the target site. To facilitate simultaneous advancement to the target site, a locking mechanism can hold the inner funnel catheter and the outer sheath together. This mechanism can be, for example, a locking tab, a snap-fit ​​feature, or a Luer connector locking thread. Upon delivery to the target site, the deployable end of the inner funnel catheter can be deployed radially to contact the inner wall of the vessel. The contour of the end can seal against the vessel wall proximal to the target site. This seals the vascular fluid proximal to the orifice and provides a large opening for easy reception of clots.

[0089] The method may include the step of covering an expandable distal end with a membrane. In an alternative example, the membrane, attached to the distal end of an outer sheath, is advanced distally. In yet another example, the membrane may be connected to the inner diameter of the funnel conduit and the outer diameter of the outer sheath.

[0090] In some examples, the step of advancing the internal funnel conduit through the outer sheath may involve moving the proximal Luer connector of the internal funnel conduit distally toward the proximal Luer connector of the outer sheath to advance the distal end of the internal funnel conduit toward the target site.

[0091] The outer sheath and the inner funnel conduit can be telescopically moved relative to each other by a mechanism, which can be a slider or a knob. In one example, the proximal Luer connector of the inner funnel conduit can accommodate a slider mechanism for advancing or retracting the position of the funnel conduit relative to the outer sheath, and the method may further include the step of moving the slider mechanism distally on the proximal Luer connector of the funnel conduit to deploy the distal end of the funnel conduit as extending beyond the distal end of the outer sheath.

[0092] In another example, the proximal Luer connector of the outer sheath may have a slider mechanism for advancing or retracting the position of the outer sheath relative to the inner funnel conduit, and the method may further include the step of retracting the slider mechanism proximally to expose the end of the inner funnel conduit and thus deploying the end of the inner funnel conduit beyond the distal end of the outer sheath.

[0093] In another example, the proximal Luer connector of the outer sheath may have a knob for advancing and retracting the position of the outer sheath relative to the inner funnel conduit, and the method may further include the steps of: rotating the knob to retract the outer sheath proximally relative to the inner funnel conduit to expose the deployable end. Reattaching the end may involve rotating the knob in the opposite direction.

[0094] The steps of capturing the thrombus in the mouth of the clot retrieval catheter may involve the use of aspiration, thrombectomy devices, or other devices and practices known in the art. When the thrombus is retrieved, the method may also include the following steps: maintaining the position of the outer sheath at the target site as an aspiration catheter and maintaining access to the target site while withdrawing the inner funnel catheter and the captured clot. Contrast agent may be injected to check vascular patency, and if an obstruction remains, aspiration may be guided through the outer sheath. The inner funnel catheter may also be re-advanced for aspiration. The outer sheath and inner funnel catheter may then be removed together or separately.

[0095] In some cases, if the blood vessel is obstructed, additional passes may be required using this device. Between passes, it may be necessary to clean clot fragments and / or debris from the lumen of the inner funnel catheter and the outer sheath. One or both of the proximal Luer connectors of the device may have ports for flushing, and in some cases, multiple channels may be formed between the proximal Luer connector of the outer sheath and the proximal Luer connector of the inner funnel catheter. The method may then further include the step of simultaneously flushing the inner funnel catheter and the outer sheath using these channels.

[0096] The invention is not necessarily limited to the described examples, the configurations and details of which may vary. The terms “distal” and “proximal” are used throughout the foregoing description and refer to position and orientation relative to the treating physician. Similarly, “distal” or “towards distal” refers to a position away from the physician or in a direction away from the physician. Likewise, “proximal” or “towards proximal” refers to a position close to the physician or in a direction toward the physician. Furthermore, unless the context clearly indicates otherwise, the singular forms “an,” “a,” and “the / described” include plural references.

[0097] 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%.

[0098] In describing the example embodiments, terminology is used for clarity. Without departing from the scope and spirit of the invention, each term is intended to be contemplated for its broadest meaning as understood by one skilled in the art, and includes all technical equivalents that operate in a similar manner to achieve a similar purpose. It should also be understood that reference to one or more steps of the method does not preclude the presence of additional method steps or intermediate method steps between those explicitly identified steps. Similarly, some steps of the method may be performed in a different order than that described herein without departing from the scope of the disclosed technology. For clarity and brevity, not all possible combinations are listed, and such variations are generally obvious to one skilled in the art and are intended to fall within the scope of the following claims.

Claims

1. An apparatus for removing an obstruction in a blood vessel, the apparatus comprising: An outer sheath, the outer sheath including a distal end, a proximal end, a proximal Luer connector surrounding the proximal end, and an inner cavity extending proximally from the distal end and terminating within the proximal Luer connector; An inner funnel conduit is located within an outer sheath. The inner funnel conduit includes an extended distal end, a proximal end, a distal end located at the distal end, a proximal Luer connector surrounding the proximal end, and an inner lumen extending proximally from the distal end and terminating at the Luer connector; the extended distal end is configured to radially self-expand when there is no constraint distal to the distal end of the outer sheath. as well as A removable locking tab is located between the proximal Luer connector of the inner funnel conduit and the proximal Luer connector of the outer sheath. The membrane attached to the inner diameter of the inner funnel conduit and the outer diameter of the outer sheath is radially expanded by radial self-expansion at the distal end.

2. The apparatus according to claim 1, characterized in that, The device also includes a slider mechanism for telescoping the inner funnel conduit relative to a fixed position of the outer sheath.

3. The apparatus according to claim 2, characterized in that, The slider mechanism is positioned on the proximal Luer connector of the inner funnel conduit.

4. The apparatus according to claim 1, characterized in that, The device also includes a knob configured to extend or retract the outer sheath relative to a fixed position of the inner funnel conduit.

5. The apparatus according to claim 1, characterized in that, The device also includes a slider mechanism for telescoping the outer sheath relative to a fixed position of the inner funnel conduit.

6. The apparatus according to claim 5, characterized in that, The slider mechanism is positioned on the proximal Luer joint of the outer sheath.

7. The apparatus according to claim 1, characterized in that, The device also includes a snap-fit ​​connection between the proximal Luer connector of the inner funnel conduit and the proximal Luer connector of the outer sheath.

8. The apparatus according to claim 1, characterized in that, The distal end is at least partially encapsulated by the membrane.

9. The apparatus according to claim 1, characterized in that, The distal end is in a collapsed delivery position within the outer sheath during the advancement of the obstruction into the blood vessel.

10. The apparatus according to claim 9, characterized in that, The collapse delivery position of the distal end is a distance between 20mm and 50mm proximal to the distal end of the outer sheath.

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