Obstruction clearing device and system

Abstract

An occlusion removal device is disclosed having one or more engagement members that are capable of engaging portions of a blood clot. The one or more engagement members have a collapsed, delivery, expanded, in use, etc. configuration, which in some embodiments, can be locked to maintain its fixed configuration.

Description

[0001] This application is a divisional application of application number 201780084363.X, filed on November 17, 2017, entitled "Obstruction Removal Device and System".

[0002] Related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 426,106, filed November 23, 2016, entitled “Obstruction Removal System,” which is incorporated herein by reference. Background Technology

[0004] The present invention relates to devices for capturing and removing obstructions (such as blood clots or other substances) from the vascular system, and methods for delivering such devices to target areas within the vascular system.

[0005] Blood clots can form when blood clots accumulate in the vascular system, restricting blood supply to downstream areas. When located in the neurovascular system, these clots can trigger a stroke.

[0006] Current techniques for removing blood clots utilize a device to hold and capture the clot, which is then removed—essentially using a physical method to remove the captured clot from the body. However, some of these devices may fail to completely capture the clot and could further accelerate its breakup, allowing the thrombus to detach and accumulate in other areas, thus prolonging the risk of stroke. Furthermore, some devices, due to significant friction with the blood vessel wall, may cause endothelial abrasion. Even worse, some devices may collapse when encountering bends in the blood vessel, increasing the likelihood of the captured thrombus escaping and / or rupturing.

[0007] Therefore, there is a need for a blockage removal device to reduce the likelihood of fragmented thrombi remaining in the vascular system while maximizing the probability of mechanically capturing blood clots to limit the risk of endothelial detachment. Summary of the Invention

[0008] One embodiment of the present invention describes an obstruction removal device having a proximal axial core structure, a distal buffer structure, and one or more connecting members mounted to the distal buffer structure.

[0009] Another embodiment of the present invention describes an obstruction removal device having a proximal structure, a distal structure, and one or more connecting members connecting the two structures.

[0010] Another embodiment of the present invention describes an obstruction removal device having a proximal structure, a distal structure, and one or more connecting members connecting the two structures, wherein at least one connecting member functions as a filter.

[0011] In one example of the foregoing embodiments, the plurality of joining members are substantially similar.

[0012] In another example of the foregoing embodiments, some of the joining members are substantially dissimilar to the rest of the joining members.

[0013] In another example of the foregoing embodiments, some of the joining members actively engage blood clots, while one or more of the remaining joining members do not engage blood clots.

[0014] In one embodiment, the obstruction removal device is enclosed within a delivery device and delivered via a conduit.

[0015] In another embodiment, the obstruction removal device is delivered directly through a catheter.

[0016] In another embodiment, the obstruction removal device is used to hunt down foreign objects.

[0017] In one embodiment, the obstruction removal device includes a plurality of obstruction engaging members connected together in pairs. The connection links a pair of engaging members together.

[0018] In one embodiment, the obstruction removal device includes a locking mechanism that locks one or more engagement members into an expanded and / or contracted shape. In another embodiment, the device includes a hysteresis tube booster and a shape controller located within the booster and extending along the entire length of one or more engagement members, wherein the shape controller is used to contract and / or expand the engagement member or to maintain the engagement member in a fixed or locked state. Attached Figure Description

[0019] Referring to the following figures, these and other aspects, features, and advantages of the embodiments of the present invention will be clearly illustrated in the following description, wherein

[0020] Figure 1 The connecting member used in the obstruction removal device is shown.

[0021] Figure 2 Another view of the connecting member used in the obstruction removal device is shown.

[0022] Figure 3 This is an obstruction removal device according to an embodiment of the present invention.

[0023] Figure 4 This is a blockage removal device according to another embodiment of the present invention.

[0024] Figure 5 for Figure 4 An exploded view of the obstruction removal device shown.

[0025] Figure 6 for Figure 4 and Figure 5 An enlarged view of the proximal engagement member of the obstruction removal device.

[0026] Figure 7 This is a blockage removal device according to yet another embodiment of the present invention.

[0027] Figure 8 for Figure 7 An exploded view of the obstruction removal device shown.

[0028] Figure 9 It shows the application to Figure 7 and Figure 8 One of the distal engagement components of the obstruction removal device.

[0029] Figures 10 to 12 A method for using the blockage removal device described in the foregoing embodiments is shown.

[0030] Figure 13 The sodium hypochlorite tube used to form the joint member is shown.

[0031] Figures 14 to 16 The process that assists in the formation of the final shape of the joining components is shown.

[0032] Figures 17 to 19 An obstruction removal device employing a hysteresis tube and a shape controller is shown, which maintains the joint member in an expanded and / or contracted shape.

[0033] Figures 20 to 21 It shows Figures 17 to 19 The hyaluronic acid tube in the blockage removal device.

[0034] Figures 22a to 23 An obstruction removal device employing a support member is shown, which serves as a strut for supporting the connecting member of the obstruction removal device.

[0035] Figures 24 and 25 show a blockage removal device with a connecting member, which employs a slit hyaluronic acid tube and a shape controller with an expansion member to lock the connecting member in place. Detailed Implementation

[0036] Specific embodiments of the present invention are described below with reference to the accompanying drawings. However, the present invention can be implemented in many other forms, and therefore the embodiments set forth herein should not be construed as limiting the invention; rather, these embodiments are provided to thoroughly and completely disclose the invention and to convey its full scope to those skilled in the art. The terminology used in the detailed description of the embodiments shown in the accompanying drawings is not intended to limit the invention. The same numerals in the drawings denote the same elements.

[0037] Unless otherwise specified, all technical and scientific terms used in this specification shall have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. It should also be understood that terms, as defined in a common dictionary, shall be interpreted as having a meaning consistent with their context in the relevant field, and shall not be interpreted as having an idealized or overly formal meaning unless explicitly defined.

[0038] For the purposes of this documentation, the terms blood clot, thrombus, embolus, and obstruction may be used synonymously. While this invention describes only an obstruction removal device, the device can also be used to capture blood clots, thrombi, emboli, foreign bodies, and other substances. Engaging members on the device can engage blood clots, thrombi, emboli, foreign bodies, emboli, and other substances.

[0039] Figure 1 and 2 The diagram illustrates a connecting member 100 in the obstruction removal device of the present invention. One or more connecting members, as part of the obstruction removal device, can be used to connect thrombi accumulated in the vascular system. Conventional connecting member shapes may include, but are not limited to, circular, oval, elliptical, hourglass, spherical, basket-shaped, stent-shaped, convex, rectangular, prism-shaped, cage-shaped, etc. Each connecting member 100 has a plurality of supports 101 and a pair of opposing holes 103 and 104, the supports 101 having a plurality of units or openings 102. Holes 103 are defined as distal holes, and holes 104 are proximal holes.

[0040] The struts, units, unit sizes, materials, and / or shapes of each connecting member can be configured with different parameters. The struts can be designed with linear, wavy, sinusoidal, or zigzag patterns, or they can be asymmetrical patterns (i.e., a strut on one side of the connecting member cannot be mirrored to the other side). An asymmetrical design of the struts can utilize the offset of the center of gravity from the geometric center of the connecting member to create a rotational component on the member as it passes through the blood vessel. This ease of rotation makes the connecting member, and therefore the obstruction removal device, easier to move through anatomical structures, especially after a blood clot has adhered to the obstruction removal device and the device has been pulled back through the vascular system. This ease of rotation also limits damage to specific portions of the vessel wall and damage to the vessel due to excessive contact friction. Each end of the connecting member can have the same or different designs. This can be achieved by changing the shape of the struts and / or units, and / or changing the unit density at each end, for example, by having one end with a larger unit size and its opposite end with a smaller unit size. This variability gives it different properties and also enhances the ability of the clearing device to engage blood clots, or enhances the ability to track obstruction clearing devices and the engaging components used to pass through blood vessels.

[0041] Figure 2 A plurality of joining members 100 having supports 101 of varying thicknesses are shown. Specifically, the proximal hole 104 may be formed by multiple end supports 101a branching out of the material, with one or more supports 101a separating to form supports 101b. Supports 101b have features 105 projecting outward from themselves. Features 105 may also be formed by any interruption on other continuous surfaces of the supports 101. These features include, but are not limited to, barbs, protrusions, spikes, forks, small pieces, etc. Next, supports 101b connect with adjacent supports 101b to form thicker supports 101c, which in turn split to form more supports 101d, also having features 105. These supports 101d then aggregate to form thicker supports 101e, which connect to form the distal hole 103. Thus, in this particular embodiment, supports interconnect to form a support network extending from the proximal hole 104 to the distal hole 103.

[0042] Alternatively, a single-strut structure can be used. For example, an extended continuous spiral strut structure can be used between the proximal and distal ends of the joint members, or between a portion thereof.

[0043] Each connecting member is in a contracted shape when it is fitted into the delivery device, but unfolds as follows when it is removed: Figure 1 and 2The expansion shape is shown. Each connecting member can contract and expand on its own, and its shape depends on whether there is an external force constraint (such as when it is fitted into the delivery device) or no external force constraint (such as when it is detached from the delivery device).

[0044] The joining component may be made of nickel-titanium alloy or similar materials, and its profile may be obtained by laser cutting. The use of other materials and other cutting and / or processing techniques also fall within the scope of this invention.

[0045] The distal hole 103 and proximal hole 104, located at the distal and proximal ends of the connecting member respectively, can accommodate a common rod, with each connecting member located on the common rod. Alternatively, the distal hole 103 and proximal hole 104 can mate with individual connectors to interconnect multiple components of the blockage removal device with their corresponding connecting members.

[0046] Figure 3 An embodiment of the obstruction removal device 200 of the present invention is shown. The obstruction removal device includes a proximal core structure 201 located at one end of the device, a distal buffer structure 202 connected to the proximal core structure 201, and one or more engagement members 203 mounted to the distal buffer structure 202. In one example, the obstruction removal device can be pushed and / or pulled from the end of the core structure 201. A booster may be located on the proximal core structure, or the proximal core structure itself may act as a booster.

[0047] The core structure 201 can be made of a variety of materials, including but not limited to nickel-titanium alloys, stainless steel, cobalt-chromium alloys, or polymeric materials such as polytetrafluoroethylene, polyethylene, thermoplastic elastomers, bonding materials, polyethylene, or other similar materials. The core structure can include, but is not limited to, coils, braids, or a combination of coils / braids.

[0048] The buffer structure 202 can be made of a radiopaque material, including but not limited to platinum, tantalum, palladium, and other similar materials. Although radiopaque materials can also be used, radiopaque materials are preferred because they facilitate imaging of the device during insertion. Mounting the engaging member onto the radiopaque buffer structure facilitates imaging of the blockage removal device during blood clot removal. The engaging member can be mounted onto the buffer structure in various ways. For example, the buffer structure may be threaded, and the hole in the engaging member may have a corresponding receiving structure that rotatably engages with the threaded external thread of the buffer structure. Alternatively, the buffer structure may be unthreaded, and the engaging member may be fixed to the buffer structure by heat treatment such as welding. Other mechanical means or other heat treatment processes can also be used to fix the engaging member to the buffer structure.

[0049] Figure 4Another embodiment of the obstruction removal device 300 of the present invention is shown. The obstruction removal device 300 includes a proximal structure 301 connecting one or more connecting members 303. A distal structure 302 is also provided, connected to the most distal connecting member (labeled 306 for clarity, although its structure may be the same as or different from the other connecting members 303). The one or more connecting members 303 are connected to the proximal structure 301 in a manner that allows them to rotate independently relative to the proximal structure 301. The one or more connecting members 303 may be interconnected, and each connecting member 303 may rotate independently of each other, as will be discussed in more detail below. Preferably, the obstruction removal device 300 is pushed / pulled from one end of the proximal structure 301, so that the proximal structure 301 and the distal structure 302 can also be considered as push / pull ends. Although five connecting members are shown in the figure, this is not intended to specifically limit the number of connecting members. As with all embodiments described previously, the connecting member 303 is constructed from one or more supports 101.

[0050] Figure 5 It shows Figure 4 An exploded view of an embodiment of the obstruction removal device 300. The proximal structure 301 may include a core wire 307 located below a coil 309, which may be located below a tube 310. The core wire 307 includes a flared end 308. The core wire 307 may be made of a nickel-titanium alloy or similar material, but other materials are also within the scope of the invention. The coil 309 may be made of tantalum or other radiopaque material, or a non-radiopaque material may be used. The tube 310 may be made of polyester or other polymeric material, although non-polymeric materials may also be used. The proximal structure also includes another coil 311, which is preferably larger than the gap between the coils 309 and may be made of a similar material. The coil 311 is located between the core wire 307 and the coil 309, keeping the core wire 307 in a central position within the coil 309. The proximal structure 301 is connected to a proximal engagement member 302. If more than one engagement member is used in the obstruction removal device, the proximal engagement member 302 may be connected to another engagement member.

[0051] The distal structure 302 includes a monofilament 315 located below the coil 316. Alternatively, multiple monofilaments may be combined to form the monofilament structure 315. The monofilament 315 may be made of a tensile-resistant polymer, such as Engage material, or other materials may be used. The coil 316 may be made of tantalum or other radiopaque materials, or a non-radiopaque material may be used. Adhesive 317 is used at both ends of the coil structure 316 to hold the monofilament 315 integrally with the coil 316 within the coil 316. The adhesive 317 is preferably a UV-curable adhesive. In one example, the distal structure may act as a guide wire.

[0052] The distal structure 302 can be connected to the distal engaging member 306. This distal structure may be radiopaque to allow imaging of the obstruction removal device during use. Figure 5 In this embodiment, the coil of the distal structure 302 is fitted within the hole 103 of the distal engaging member 306, and the support member 312 is fitted at the other end of the engaging member 306 to keep the distal structure 302 and the engaging member 306 integral. The support member is welded into the hole 103. The engaging member 306 can still rotate. The support member can be tubular and can be made of a nickel-titanium alloy, but similar materials can also be used. To aid imaging, the support member can be made of a nickel-titanium alloy doped with a radiopaque material. Alternatively, the support member can be coated with a radiopaque material to aid imaging of the device during the process. Alternatively, the support member can be made of a radiopaque material.

[0053] The connection relationship of the joint components is as follows Figure 5 and Figure 6 As shown. Figure 6 The connection structure of the connecting member 303 is shown, which is connected to the proximal structure 301 of the blockage removal device.

[0054] The connecting mechanism includes a connector 313 with two flared ends 314 and a support 312. The connector 313 can be made of stainless steel or a similar material. The flared ends extend within two opposing holes 103, 104 of the connecting member, and the support 312 is positioned beside the flared ends 314 to ensure that the connector 313 is secured within the holes of the connecting member. If the obstruction removal device uses more than one connecting member, this connecting structure connects the connecting members together. The support 312 is welded to the holes, and the connector is rotatable while being secured within the holes of the connecting member. The connecting member can rotate independently.

[0055] like Figure 5 and 6 As shown, the connecting member 303 is simultaneously connected to the proximal structure 301. The flared end 308 of the core wire passes through the hole 104 of the connecting member 303, and the support member 312 extends beyond the core wire 307 to ensure that the proximal structure 301 mates with the connecting member 303, wherein the support member 312 is welded within the hole 104. A smaller, gapped coil 311 is located at the distal end of the coil 309, and the core wire 307 is centered within the coil 309.

[0056] In one example, connector 313 is placed within a hole, and support 312 is welded to the hole on connector. The flared end 313 can then be laser-welded to the end of connector. In another example, support 312 is welded into a hole, connector is placed within the hole, and the flared end is laser-welded. Although laser welding is explicitly specified, other similar heat treatment techniques may be used. This process can also be used to create a flared end 308 at the end of core wire 307 and to connect the nearest engaging member 303 to the proximal structure 301 of the device. In one example, this process can also be used at the end of coil 316 when connecting the distal structure of the device to the distal engaging member 306. Each engaging member has a rotating component; its rotational capability aids in thrombus capture and vessel navigation. The rotating component also helps control residual forces that accumulate due to excessive contact friction between the strut and the vessel wall, thereby helping to control potential endothelial erosion that may occur when the device is pushed and / or pulled as it passes through the vessel. Engaging members may also have a more rounded, smoother structure (as shown in the figure). Because of its sharp edges, prolonged contact and friction will lead to endothelial erosion. Furthermore, due to the gaps between the connecting components, this invention physically minimizes material contact with the blood vessel compared to other designs, such as those using longer, one-piece clot-jointing units. Less material in contact with the blood vessel better limits endothelial erosion during clot removal.

[0057] In one example, the proximal structure 301 of the blockage removal device may include means for separating the engaging member from the blockage removal device. The separating means may include a portion of the proximal portion 301 that contacts the engaging member 303 (the engaging member at the nearest end), and may include electrolytic, mechanical, thermal, or other means known in the art to break and / or weaken the connection.

[0058] One or more engaging components can actively engage the thrombus, while other components may be already away from or still at a distance from the thrombus, depending on the size of the blood clot and the number of engaging components used in the device. Given the potential variability in the individual shape and / or profile of each engaging component, and the number of engaging components in the blockage removal device relative to the size of the blood clot, one or more engaging components may be already away from the blood clot and have a denser unit structure, acting as a filter to capture the thrombus during the process of capturing the blood clot using the blockage removal device and dislodging the thrombus.

[0059] The connecting member acting as a filter may have a mesh structure; the mesh structure may extend throughout the connecting member or be located at a specific point on the connecting member to maximize the capture of loose thrombi without causing thrombus detachment. In one example, the connecting member acting as a filter has a denser unit structure on the distal side to capture thrombi that detach from the interaction between the proximal connecting member and the blood clot. This arrangement is advantageous when the proximal connecting member interacts with the blood clot and the blood clot is partially impregnated. The distal connecting member acting as a filter can capture softened thrombi to prevent their accumulation in the bloodstream. The connecting member acting as a filter may be made of nickel-titanium alloy, stainless steel, or similar materials.

[0060] Alternatively, it can be formed from laser-cut polymer. Or, these connecting members used as filters can have an inverted braided structure, or other basket-like structures, or other structures known in the field of embolism protection devices. One or more connecting members can also be made of a coagulation material, or can be coated with a coagulation material to facilitate the blood clot hunting process by enhancing the adhesion between the connecting member and the thrombus. Alternatively, antithrombotic materials, or antithrombotic coating materials, can be used to help dissolve the blood clot in contact with the connecting member. This is particularly effective for hunting operations involving relatively large blood clots.

[0061] Figure 7 and Figure 8 Another embodiment of a blockage removal device is shown, which utilizes one or more engaging members that act as filters to capture blood clots that may dislodge during the blood clot removal process. Figure 7 A blockage removal device with a proximal portion 401 and a distal portion 402 is shown. The proximal portion includes an engaging member 303. The distal portion includes engaging members 407 and 408. The unit structure of the distal engaging members 407 and 408 has a high density to act as a filter to capture detached thrombi that may be sheared off during the clot removal process. The clot removal process is as described above. Figure 8 As shown, the unit structure has a high density due to the internal and external structures used to form the joint members.

[0062] like Figure 8 As shown, each of the two distal engaging members 407 and 408 consists of an internal structure 409 and an external structure 410, wherein the internal structure can be nested within the external structure. The internal structure 409 and the external structure 410, including the distal engaging members 407 and 408, can be made of laser-cut nickel-titanium alloy or similar materials. The construction of the proximal portion 401 and the distal structure 402 is similar to... Figure 4 , Figure 5The embodiments shown are identical, and the connections between each connecting member are also identical, although this filter connecting member structure can be applied to any connecting member presented in this blockage removal device embodiment.

[0063] When an inner structure is nested within an outer structure, the element pattern can be slightly offset across both the inner and outer structures to produce a denser element profile. For example... Figure 9 As shown, the distal portion 510 of the connecting member 408 has a higher unit density than the proximal portion 511 in order to capture displaced thrombi that may escape during clot clearance. This arrangement is advantageous when the closer connecting member interacts with the clot and when the clot is partially impregnated. The distal connecting member, acting as a filter, can capture softened thrombi to prevent their accumulation in the bloodstream. Although Figure 7 and Figure 8 A connecting member with both internal and external structures that has a filtering function is shown, but more or fewer connecting members may have this filter structure.

[0064] In one embodiment for delivering the device described in the foregoing embodiments, the obstruction removal device is housed within a delivery device, which is delivered via a catheter. In one example, the delivery device may be a microcatheter. The delivery device is delivered to the obstruction site and then pulled back. The obstruction removal device is pulled back with the delivery device to cause the engaging member to expand as the delivery device is pulled back.

[0065] Alternatively, the obstruction clearance device is pushed out of the delivery device, followed by expansion of the engagement member. Depending on the number of engagement members on the obstruction clearance device, the size of the blood clot, and the delivery location relative to the embolism, some members may be already away from or still far from the obstruction. The obstruction clearance device can be controlled via the core wire. Once the obstruction clearance device engages with the obstruction, the delivery device can be withdrawn to a point just past the distal end of the catheter, followed by catheter withdrawal. Alternatively, the obstruction clearance device can be withdrawn from the vascular system by withdrawing the delivery device back into the catheter and then withdrawing the catheter; or by withdrawing the delivery device and / or the obstruction clearance device directly through the catheter. Alternatively, the entire catheter can be withdrawn to remove both the delivery device and the obstruction clearance device. In another example, the delivery device may be a hypotube.

[0066] In another embodiment, the device can be delivered directly through a conduit without being nested within a delivery device.

[0067] Figures 10 to 12An example of a specific method for using an obstruction removal device is shown. In this example, delivery device 602 is delivered to the location of blood clot 601 via vascular system 600. Obstruction removal device 603 is pushed to the location of blood clot by delivery device. Although this example explicitly shows an obstruction removal device for use in a blood clot, the device can be placed inside the blood clot or at a proximal or distal position relative to the location of the blood clot. Depending on the number of engaging members on the obstruction removal device, the size of the blood clot, and the delivery position relative to the embolus, some members may already be away from or still be far from the obstruction. Delivery device 602 then retracts, causing the engaging members of the obstruction removal device to expand and interact with the portion of the blood clot. An operator can manipulate obstruction removal device 603 from its proximal portion 604. Once the obstruction removal device has secured the blood clot, it can be withdrawn as described above. Blood clots / obstructions can also be removed by suction. Figure 10-12 A specific example is shown for illustrative purposes. Other delivery methods are conceivable within the scope of the invention, such as ejecting the obstruction removal device from the delivery device.

[0068] The joining components can have the same size, can have different sizes, or some joining components can have different sizes than the others. In one example, the diameter of the spherical joining component can range from 1 to 12 mm. In another example, the diameter ranges from 3 to 6 mm.

[0069] The joining component is made of a sodium hypochlorite tube, which is laser-cut into a specific pattern based on the shape of the support column 101 and the unit 102. The sodium hypochlorite tube 700, as shown... Figure 13 As shown. The sodium hypochlorite tube undergoes heat treatment; in one example, it is heated to 530-550 degrees Celsius for 5 minutes. The tube is then quenched and cooled in water. An expansion plunger 702 is then inserted to expand the portion of the tube (see...). Figure 14 The expanded thiocyanate tube is heat-set to its expanded shape. In one example, it is heated at 530-550 degrees Celsius for 3 minutes. The expanded thiocyanate tube is then quenched in water to cool. Depending on the dimensions of the joining components, expansion plungers and subsequent heat treatment steps can be used for multiple parts of the joining components, each of which is heat-set after expansion. Expansion pins 704 are then inserted into the thiocyanate tube to aid in the expansion of the tube walls (see...). Figure 15 The expanded sodium hypo tube 700 is placed in a fixture. The fixture comprises two plates 706 and 708. A screw connects the two plates, which are provided with external mounting nuts. Tightening the nuts compresses the plates together, further expanding the sodium hypo tube. Once the appropriate shape is achieved, the expanded sodium hypo tube can be heat-treated (in one example, at 530-550 degrees Celsius for 5 minutes) and quenched to set the shape of the joint.

[0070] The joining components are then acid-washed, etched, and electropolished to define their final shape. One or more joining components are then assembled to form a blockage removal device. Although the joining components are heat-set and processed into an expanded shape, they retain a high degree of shape memory due to factors such as material properties and support thickness. Therefore, when unconstrained, the joining components will exhibit an extended shape (i.e., not fitted into the delivery device), and when constrained, they will exhibit a contracted shape similar to the initial shape of the submersible tube (i.e., fitted into the delivery device).

[0071] In several embodiments of the previously presented obstruction clearance devices, the engaging member is self-expanding upon release from the delivery device (e.g., a microcatheter) and self-contracting while contained within the delivery device. In some embodiments and cases, a locking feature that locks one or more engaging members in an expanded and / or contracted form is highly advantageous. Neurovascular structures are small and tortuous. When an obstruction clearance device and its associated engaging member are used to clear blood clots in the neurovascular system, the geometry of the vessel may prevent the engaging member from fully opening, or cause the engaging member to collapse prematurely after the blood clot has been captured, as the device retracts through and exits the patient's vascular system. Locking the engaging member in an expanded form solves these problems.

[0072] For the purposes of discussing the accompanying drawings, unless otherwise stated, anything on the left side of the drawings is considered distal (or in the direction of further placement within the vascular system), and anything on the right side is considered proximal (or in the direction of obtaining vascular access).

[0073] Figure 17 An obstruction removal device 800 is shown, which is generally similar to the aforementioned embodiments, further including mechanisms for manipulating or maintaining the expanded shape of the engagement members 802a to 802d. The device 800 includes a plurality of engagement members 802a to 802d (e.g., four members) connected to each other in a straight line. The nearest engagement member 802d is connected to the distal end of an elongated booster 806.

[0074] The actuation mechanism is controlled by a shape controller member 808 connected to the distal engagement member 802d and extending through each engagement member 802a to 802d, through the channel of the booster 806, and terminating at or near the proximal end of the booster 806. Thus, the physician can pull the shape controller member 808, pulling the engagement members 802a to 802d against the distal end of the booster 806, maintaining their inflated shape.

[0075] The booster is preferably an elongated body with a diameter suitable for passage within a conduit or sheath, and its interior further includes an inner cavity or channel accommodating the shape controller 808. Similar to... Figure 1 In the previously illustrated embodiment, each coupling member 802a to 802d includes proximal and distal holes 103, 104, which are aligned with each other along the longitudinal axis of the device 800 and with the channel of the booster 806. Additionally, each coupling member 802a to 802d includes tubular members 804a to 804d (e.g., metal thiocyanate tubes) that are connected only to the distal or "left" end (or proximal end) of each coupling member, and not to the opposite sides of the coupling members 802a to 802d. The tubular members 804a to 804d are each aligned such that the internal channels they form are interconnected between the proximal and distal holes of each coupling member 802a to 802d. This creates a channel through the booster, the coupling members 802a to 802d, and the tubular members 804a to 804d. Various techniques, including adhesives, welding, or machine screws, can be used to connect tubular members 804a to 804d to joint members 802a to 802d.

[0076] A shape controller 808 passes through the channel, including through the inner cavity of the booster, engaging members 802a to 802d, and tubular members 804a to 804d. At the distal end of the most distal engaging member 802a, a distal cap 810 is attached to the distal end of the shape controller 808. Similarly, adhesive, solder, or mechanical screw concepts can be used for this attachment, and preferably, the diameter of the cap 810 is larger than the diameter of the distal hole in the distal engaging member 802d. Alternatively, the shape controller 808 can be mechanically and directly connected to the distal end of the distal engaging member 802a.

[0077] The shape controller 808 is detachable from the booster 806 because it is located within the booster cavity, allowing the user to move the controller 808 longitudinally independently relative to the booster 806. When the booster 806 is used to control the position of the entire obstruction removal device and its attached / associated engagement members 802a to 802d, the controller 808 controls the shape of the engagement members 802a to 802d. Preferably, the shape controller 808 is a wire, a flexible rod, or a similar elongated element extending between the distal end and at least the proximal end of the device.

[0078] Because the shape controller 808 is connected to the distal cover 810, pushing the controller 808 generates a distal force against the cover 810 (or, if no such cover is used, the distal end of the distal engaging member 802a). Since the tubular members 804a to 804d are only fixed to the left side or distal end of the engaging member, the tubular members 804a to 804d do not contact the proximal end of the engaging member, as... Figure 18As shown, and as the joining members 802a to 802d change into an elliptical and / or elongated shape, the tubular members 804a to 804d will move distally. Conversely, the pull or retraction controller 808 applies a reverse proximal force to the cap 810 (or the distal joining member 802a if there is no cap), causing the joining members 802a to 802d to expand radially into a spherical shape until the floating end or proximal end of the tubular members 804a to 804d contacts the inner proximal end face of the joining member, thereby preventing further expansion of the joining members 802a to 802d and further proximal movement of the shape controller 808. In this way, the attached tubular members 804a to 804d serve to prevent excessive expansion of the joining members 802a to 802d. In one embodiment, tubular members 804a to 804d are attached only to one end of the connecting members 802a to 802d (e.g., the left or distal end of the connecting members), and this particular attachment end may be made of a dense counterweight material, thereby providing resistance to movement in that particular direction. For example, when tubular members 804a to 804d are attached to the distal ends of the connecting members 802a to 802d, the distal end of each connecting member will be weighted and naturally resist the natural forces that could cause the connecting members to collapse due to movement through the vascular system. Therefore, even if the user does not use a shape controller to expand or contract the connecting members, the presence of the tubular members naturally resists changes in the shape of the connecting members.

[0079] During use within the patient, the morphology controller 808 can be used to prevent the engagement members 802a to 802d from contracting, especially when passing through curved or tortuous areas. However, the user can still withdraw the device 800 (e.g., into a sheath or catheter) to allow the engagement members 802a to contract as intended.

[0080] In one embodiment, the controller 808 includes a clamp or other locking mechanism at its proximal end, allowing a user to lock the position of the controller relative to the booster 806, and also lock the shape of the engagement members. Other embodiments may not use a locking mechanism, but instead rely on a force applied by the user to the controller 808 to manipulate the engagement members 802a to 802d into and maintain a specific shape.

[0081] Figure 19 An alternative embodiment of the device 801, similar to the previously described device 800, is shown. However, tubular members 804a to 804d are instead fixed to the proximal (or right) end of the coupling members 802a to 802d, rather than as... Figure 18 The distal (or left) ends of the connecting members 802a to 802d shown. In this embodiment, pushing the controller 808 still causes the connecting members 802a to 802d to contract, while pulling the controller 808 still causes the connecting members to expand.

[0082] In one example, the propeller tube 806 is a tapered nickel-titanium alloy hyaluronic acid tube with an inner diameter of approximately 0.004 inches and an outer diameter of approximately 0.015 inches, and the shape controller 808 is a metal wire with an outer diameter of approximately 0.003 inches. The metal wire can be made of a variety of materials, including metals, fibers, and polymers, such as nickel-titanium alloy, stainless steel, high-strength fibers, Kevlar fibers, polyester, and polypropylene. The dimensions described above are merely examples and can be increased or decreased depending on the size of the obstruction removal device. The shape controller 808 can also take the form of a wire, hyaluronic acid tube, or other components. The proximal end of the shape controller 808 may also include a handle or similar user interface for easier user operation.

[0083] In one embodiment, the tubular members 804a to 804d are radiopaque to aid in imaging. Other radiopaque materials, such as platinum, tantalum, palladium, or gold, can be used. Imaging is beneficial because physicians can determine whether the joining members are in a constricted or expanded state based on the relative positions of the tubular members. Figure 18-19 As shown, when the connecting members contract, the tubular members 804a to 804d exhibit a spaced-apart structure. Using radiopaque imaging techniques on the tubular members, the physician can see... Figure 20 The gapped tubular structure shown confirms that the joint member contracts. Conversely, when the joint member expands (as... Figure 17 As shown), tubular members 804a to 804d are closely grouped together in a continuous linear arrangement, as... Figure 21 As shown, the expansion of the joint component is confirmed. In this way, physicians can use imaging techniques to determine whether the joint component is in a contracted or expanded state.

[0084] Other embodiments may utilize coil elements instead of tubular members 804a to 804d, spanning the entire length of each joining member 802a to 802d. The advantage of the coil element is that it can be attached to either end of the joining member, where the tensile strength of the coil causes the joining member to contract or expand. Alternatively, the coil element can be like... Figures 17-21 The same as the tubular members 804a to 804d, wherein one end of the coil is fixed to the connecting members 802a to 802d, while the other end is unrestrained.

[0085] As previously mentioned, the presence of a coil or tubular component helps to naturally resist the collapse of the joint member. The coil or tubular component can therefore be considered a tensioning component, resisting the collapse of the joint member. However, one embodiment may omit the coil or tubular component, utilizing only the controller 808 as the sole mechanism for controlling the shape of the joint element. In this embodiment, the user can control the shape of the joint member, but cannot use a "stop" mechanism to prevent the joint member from being excessively radially expanded by the shape controller 808.

[0086] Figure 22a , 22bFigures 2 and 23 illustrate a device 803 that is generally similar to the foregoing embodiments 800 and 801. The controller 808 of this embodiment includes a locking element 812 that can engage or lock with a portion of the engagement element to lock the engagement element in a particular shape, rather than relying on the user to hold the shape controller in position or relying on a separate clamping mechanism to lock the shape controller 808 (and thus lock the engagement elements 802a to 802d to a particular shape).

[0087] Similar to Figure 17-21 In this embodiment, the system utilizes a proximal booster 806 and a shape controller 808 located within a conduit through the booster 806, distal to the booster, and spanning aligned engagement members 802a to 802d. The controller 808 includes fixing devices for a plurality (e.g., four) of star-shaped supports 812a to 812d, each support being fixed to a controller within the engagement members 802a to 802d (i.e., each engagement member has a support therein). The distal end of the shape controller 808 is connected to a distal cap element, or to the distal engagement member 802a, which, when pushed, causes the engagement member to contract, while pulling the controller 808 causes the engagement member to expand. Since the supports 812a to 812d are fixed to the controller, the supports will displace with the displacement of the shape controller 808. In view of this, the support is further provided with a stop mechanism to limit the length of the controller 808 retracting to the proximal side, thereby limiting the shape and radial expansion of the connecting members 802a to 802d.

[0088] Figure 22b The star-shaped supports 812a to 812d, shown in detail, include channels 815 for placing the shape controller 808. Mechanical means such as welding or adhesives can be used to attach the supports to the controller, or the supports can be integrally formed with the shape controller 808. The supports include a plurality of curved radial grooves, recesses, or slots 816 in a generally star-shaped form. Furthermore, the supports 812 include a tapered proximal surface and a flat distal surface. Since the supports 812a to 812d are located on the shape controller 808, retracting or pulling the controller will also move the supports 812, causing them to engage the proximal supports of their corresponding engagement members 812. The grooves 816 of the supports are sized to engage or partially accommodate the engagement member supports. Therefore, pulling the controller 808 will cause the supports 812a to 812d to come into contact with the engagement member supports, and the supports will remain accommodated in the slots / grooves 816 of the supports 812. The support 816 can be made of a variety of materials, such as nickel-titanium alloy, stainless steel, polymer, or non-transparent materials, such as tantalum, platinum, palladium, or gold.

[0089] The groove 816 may be wider than or slightly larger than the support post to directly accommodate the support post. Optionally, the slot / groove 816 may include a tapered proximal surface having a curvature that is substantially similar to but inverted to the interior of the engaging member 812, so that the two surfaces mate with each other.

[0090] Device 803 can be configured to have a permanent or temporary support locking function. For example, in a permanent locking design, the support is permanently locked to the support member, and consequently the controller 808 is also locked. In a non-permanent / temporary locking design, the user can apply sufficient force (e.g., by pushing the controller 808 with sufficient force to overcome the locking force) to release the support from the groove 816 of the support member 812, thereby unlocking the system.

[0091] When the shape controller 808 is pulled from the proximal end, the supports 812a to 812d engage the proximal supports of the connecting members 802a to 802d (or from the right side in the figure) to lock the connecting members into an expanded shape, as shown. Figure 23 As shown. This function can also be used to lock the joint member in a retracted state, where pushing the controller 808 will cause the support to engage the distal (or, viewed from a favorable angle to the left in the attached figure) strut, allowing the joint member to retract. Figure 1 As can be seen most clearly, the proximal and distal support structures are arranged in a bulb petal shape, radiating from holes 103 / 104 to form five support regions 101. The support member 812 also includes five recessed regions 816, each recess corresponding to one support region. Other embodiments may use different support patterns and utilize different numbers of recesses 816 to accommodate different support patterns.

[0092] Please note that in the previous embodiments, the joining member includes a joining member placed along the common core member (e.g., Figure 3 ) and connecting members that pair and connect their respective separate connecting elements (e.g., Figure 5-6 Any embodiment can be used in conjunction with the locking or shape-changing functions described in relation to shape controller 808. In a common core component (e.g., as...) Figure 3 When spanning all the joining members (as shown), the controller 808 can replace the larger tubular structure shown, or the controller can adopt the common tubular core structure shown and place the various joining members on this structure. When using individual connecting elements 313 to connect the joining members in pairs (e.g., as shown) Figure 5 As shown), each connecting element 313 may be located within the cavity accommodating the shape controller 808.

[0093] Other embodiments may use supports that only partially surround the shape controller (e.g., only the top or bottom of supports 812a to 812d), which engage only some of the struts. Still other embodiments may use only one support, such as a distal support for locking the distal engaging member, or a proximal support for locking the proximal engaging member. While multiple supports enhance the locking capability on each engaging member, embodiments with a single support can simplify the locking operation while applying some locking force to multiple engaging members.

[0094] In one embodiment, both the contraction and expansion forms can be locked, allowing the engaging member to be locked in both expansion and contraction forms. In another embodiment, only the contraction form can be locked. In yet another embodiment, only the expansion form can be locked. The locking capability can be controlled by various variables, such as the position of the supports 812a to 812d within each engaging member 802a to 802d, the size of each support, and the overall displacement of the form controller 808. In one embodiment, a clamp locking mechanism at the proximal portion of the form controller 808 can also be used with the supports to further enhance the locking force of the engaging member.

[0095] Figure 24a and Figure 24b Another embodiment of the thrombus removal device is shown, which uses a similar morphology controller 808 to those described in the previous embodiments, but employs a different locking mechanism to maintain the position of the morphology controller 808. Specifically, the morphology controller 808 may include one or more expansion members 818 that engage or enter the channel 820 (e.g., hole, groove, or recess) of the tubular booster 806, thereby locking the morphology controller 808 in its longitudinal position. Preferably, the region of the cavity opposite and adjacent to the channel 818 is configured as a shape that facilitates pushing or guiding the expansion member 818 into the channel 820, such as a ramp or protrusion. Although only one channel 820 is shown, two channels are also feasible, as long as they are designed to hold the engaging member 802 in a contracted or expanded position at a locked or braked position.

[0096] Similar to other embodiments, the shape controller 808 is connected to the most distal engagement member (or distal cap). Pulling the controller causes the engagement member 802 to expand, while pushing the controller causes the engagement member 802 to collapse. To lock the engagement member in the expanded shape, the user pulls or pushes the controller 808, causing the expansion member 818 to be positioned within the channel 820 and moved into the channel, thereby locking the engagement member in place.

[0097] Figure 25a and Figure 25bAnother embodiment without channel locking is shown. Instead, the expander 118 is made of a slightly ductile material, allowing it to be compressibly fitted within the distal end of the thruster tube when further retraction is impossible. Optionally, the expander tapers towards the distal end, further facilitating entry into the booster 806 while also preventing pull-back. The cavity of the booster 806 may also be tapered, with its distal portion slightly larger than its proximal portion, thereby preventing the expander 818 from moving proximal beyond a certain point, thus maintaining the structure of the expander 818. In one embodiment, this configuration remains unchanged once the engagement member 802 is locked. In another embodiment, the user can apply sufficient force to remove the expander 818 from the aforementioned retaining structure to unlock the engagement member's position.

[0098] While the above embodiments are only used to lock the joining member in an expanded form, other embodiments may also, or alternatively, utilize a distal tubular structure to lock the joining member in a contracted form. In these embodiments, the distal tube (e.g., similar to...) Figure 5 The distal tubular structure 302 is connected to the distal end of the most distal engaging member, and this tubular structure utilizes the same retaining structure as in Figures 24-25 to lock the expansion member along the shape controller 808. In this way, the engaging member can be locked in either an expanded or contracted shape. An alternative embodiment may utilize this distal retaining structure alone, such that the engaging member can only be locked in a contracted shape.

[0099] In embodiments of the joining members connected by a connecting structure, this embodiment can be applied within the connecting structure 313 (see...). Figure 5 In this embodiment, the connection structure 313 also adopts the configuration shown in Figures 24-25, and has multiple expansion members 818 (e.g., four engaging members and four expansion members, each expansion member used to lock the engaging members) along the controller 808. Pushing / pulling the configuration controller 808 causes the expansion members 818 to cooperate with the locking structure to lock the engaging members in an expanded and / or contracted configuration. Multiple locking structures further increase the locking strength, maintaining the engaging members in a specific configuration, but also increase the complexity of the locking mechanism. The advantage of a single locking structure (located on the booster 806 or connected to the distal tubular structure of the distal or furthest engaging member) is that one locking structure can be used to lock multiple engaging members, while potentially allowing the user to unlock the engaging members by applying sufficient force. Typically, in most cases, it is beneficial for the user to be able to selectively lock or unlock the engagement member configuration, for example, locking the engagement member in the expanded configuration to help retain the blood clot. However, the subsequent unlocking of the engagement member to allow it to retract into the sheath after the blood clot / embolism clearance process is completed and withdraw from the vascular system is usually more complex.

[0100] In another embodiment, the locking mechanism is calibrated so that the operator can determine the appropriate diameter of the engagement member based on the diameter of the blood vessel and lock the engagement member to the appropriate diameter size. In this way, the operator can change the diameter based on varying anatomical structures (e.g., when the device moves from the smaller diameter M2 segment of the middle cerebral artery to the larger diameter M1 segment, the operator can choose to "lock" the device to the larger diameter corresponding to the larger M1 size than the M2 segment).

[0101] In another embodiment, the locking mechanism is designed to allow the operator to select different levels of resistance. If the operator experiences excessive resistance when withdrawing the obstruction removal device, he or she can temporarily "release" the locking mechanism, increasing the flexibility of the engaging member and reducing resistance. For example, the locking mechanism may have a degree of freedom or "yield" to reduce resistance while maintaining the engaging member locked in an expanded and / or contracted shape.

[0102] In another embodiment, in addition to blood clots or other emboli, the device mentioned in the foregoing embodiments can also be used to remove foreign bodies. Foreign bodies (such as embolic coils typically used to fill aneurysms) may become dislodged or detached within the vascular system. The device can be used to retrieve foreign bodies, following procedures similar to those used to clear emboli.

[0103] While previous embodiments have disclosed various mechanisms for locking the shape controller in a longitudinal position, it should be understood that the term "locking mechanism" can also be interpreted in some cases as including the shape controller and one or more distal structures fixed to the distal end of the shape controller to contact / engage the engagement member.

[0104] Although the invention has been described with reference to specific embodiments and applications, other embodiments and modifications can be conceived by those skilled in the art based on these teachings without departing from the spirit or scope of the claimed invention. Therefore, it should be understood that the accompanying drawings and descriptions provided herein are intended to aid in understanding the invention by way of example and should not be construed as limiting the scope of the invention.

Claims

1. An obstruction removal device, comprising: Includes channel boosters; A slender component extending from the booster; Multiple connecting members are fixed to an elongated member, such that pulling the elongated member causes the multiple connecting members to expand, while pushing the elongated member causes the multiple connecting members to contract. An expansion member, located on an elongated member, engages or enters a channel to lock the elongated member in a fixed longitudinal position; and A locking mechanism that selectively prevents the elongated member from moving relative to the booster, wherein the locking mechanism includes a fixing device that is fixed to the elongated member and positioned within each of a plurality of engaging members, the fixing device having a plurality of grooves adapted to align and engage with the plurality of engaging members.

2. The obstruction removal device according to claim 1, wherein, The channel is composed of holes.

3. The obstruction removal device according to claim 1, wherein, The channel is composed of grooves.

4. The obstruction removal device according to claim 1, wherein, The channel is composed of recesses.

5. The obstruction removal device according to claim 1, wherein, The booster includes a second channel.

6. The obstruction removal device according to claim 1, wherein, The area of ​​the booster's inner cavity opposite the channel includes a ramp.

7. The obstruction removal device according to claim 1, wherein, The area of ​​the booster's inner cavity opposite the channel includes protrusions.

8. The obstruction removal device according to claim 1, wherein, The channel is formed on one side of the booster.

9. The obstruction removal device according to claim 1, wherein, The slender component runs through the booster and multiple connecting components.

10. An obstruction removal device, comprising: booster; A slender component extending from the booster; Multiple connecting members are fixed to an elongated member, such that pulling the elongated member causes the multiple connecting members to expand, while pushing the elongated member causes the multiple connecting members to contract. An expander, located on an elongated member, is made of a ductile material, which allows the expander to be press-fitted into the distal end of the booster. and A locking mechanism that selectively prevents the elongated member from moving relative to the booster, wherein the locking mechanism includes a fixing device that is fixed to the elongated member and positioned within each of a plurality of engaging members, the fixing device having a plurality of grooves adapted to align and engage with the plurality of engaging members.

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