guide wire

Abstract

This invention relates to the field of medical device technology, and more particularly to a guidewire. The guidewire includes a spool and a tube, with a umbrella-shaped portion within the tube. The guidewire provided by this invention controls the umbrella-shaped portion within the tube to be in an expanded or closed state simply by controlling the relative axial movement of the proximal ends of the spool and the tube, thereby controlling the umbrella-shaped portion to filter and collect thrombi. In this process, no catheter is required, eliminating the need for catheter advancement within the blood vessel during thrombus filtration and collection. Furthermore, due to the guidewire's inherent flexibility, its movement within the blood vessel is smoother. Moreover, the guidewire can not only be used for thrombus filtration and collection but also as a guide for other medical devices' intravascular access during interventional procedures. This achieves a multi-purpose effect and eliminates the need for additional steps in the anti-embolism umbrella access procedure, thus reducing harm to the patient during interventional procedures.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a guidewire. Background Technology

[0002] Current anti-embolism umbrellas are widely used in interventional procedures. Their main function is to intercept and recover thrombi or plaque fragments generated during the procedure to reduce the risk of stroke and distal embolism.

[0003] Currently, most common antithrombotic protective devices employ a design where the filter is pre-installed within the catheter: guided by a guidewire, the filter is delivered to the target location in the blood vessel through the catheter and then released; after the interventional procedure is completed, the filter is retrieved back into the catheter. The filter size must be matched to the diameter of the target blood vessel; larger vessels require larger filters, which in turn necessitate larger catheters. Since the catheter needs to be advanced within the blood vessel, its diameter and axial support strength directly affect the smoothness of the delivery process. Unsmoothness during catheter delivery not only affects thrombus filtration and collection but may even cause scratches or other damage to the blood vessel wall. Summary of the Invention

[0004] This invention provides a guidewire capable of filtering and collecting thrombi without the need for a catheter, and capable of being smoothly advanced and moved within blood vessels.

[0005] The guidewire provided in this embodiment of the invention includes a guidewire spool and a guidewire tube, wherein the guidewire tube is disposed outside the guidewire spool and is at least partially movable axially relative to the guidewire spool; the guidewire tube includes a main body and a canopy, wherein a hollow cavity is formed in the main body, the guidewire spool is disposed in the hollow cavity, the proximal end of the canopy is connected to the distal end of the main body, the distal end of the canopy is fixedly connected to the guidewire spool, and the guidewire spool is sleeved in the canopy; by controlling the relative axial movement of the proximal end of the guidewire spool and the proximal end of the guidewire tube, the canopy can be controlled to arch radially away from the guidewire spool or to move closer to the guidewire spool, thereby making the canopy in an deployed state or a closed state; wherein, when the canopy is in the deployed state, the canopy is at least used to filter thrombi; when the canopy is in the closed state, the canopy is at least used to collect thrombi.

[0006] Therefore, the guidewire provided in this embodiment of the invention can control the umbrella portion of the tubing to be in an expanded or closed state simply by controlling the relative axial movement of the proximal end of the guidewire shaft and the proximal end of the tubing, thereby controlling the umbrella portion to filter and collect thrombi. In this process, no catheter is required, thus eliminating the need for catheter advancement within the blood vessel during thrombus filtration and collection. Furthermore, due to the guidewire's inherent flexibility, its movement within the blood vessel is smoother overall. Moreover, the guidewire can not only be used for thrombus filtration and collection but also as a guide for other medical devices entering the blood vessel during interventional procedures. This achieves a multi-purpose effect and saves the need for additional steps in the anti-embolism umbrella approach, thereby reducing harm to the patient during interventional procedures. Attached Figure Description

[0007] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0008] Figure 1 This is a schematic diagram of the guidewire in the deployed state according to the first embodiment of the present invention; Figure 2 This is a schematic diagram of the guidewire in the closed state according to the first embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the guide wire tube provided in an embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the guide wire tube provided in another embodiment of the present invention; Figure 5 This is a schematic diagram of the guidewire in the deployed state according to the second embodiment of the present invention; Figure 6 This is a schematic diagram of the guidewire in the deployed state according to the third embodiment of the present invention; Figure 7 This is a schematic diagram of the guidewire in the closed state according to the fourth embodiment of the present invention; Figure 8 This is a schematic diagram of the guidewire in the deployed state according to the fourth embodiment of the present invention; Figure 9 This is a schematic diagram of the guidewire in the deployed state according to the fifth embodiment of the present invention; Figure 10 A schematic diagram of a guidewire in a closed state according to the sixth embodiment of the present invention; Figure 11A schematic diagram of the guidewire in the deployed state according to the sixth embodiment of the present invention; Figure 12 This is a schematic diagram of another structure of the guidewire in the deployed state according to the sixth embodiment of the present invention; Figure 13 This is another structural schematic diagram of the guidewire in the closed state according to the sixth embodiment of the present invention. Detailed Implementation

[0009] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0010] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0011] While terms such as "first," "second," "third," etc., may be used in the text to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used in the text do not imply order or sequence.

[0012] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of the medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and based on this principle, the "axial direction" of any component of the medical device is defined. Correspondingly, "radial direction" generally refers to the direction passing through the central axis of the medical device's axial direction and perpendicular to the length direction of the medical device during delivery, and "circumferential direction" generally refers to the direction around the outer periphery of the axial direction. In this invention, the component in the umbrella section being "covered" by the film means that the component is covered by the film at least on the radially outer and / or radially inner side of the umbrella section surrounded by several thin rods.

[0013] In existing antithrombotic protection systems, the system typically requires the use of guidewires, catheters, and sheaths. The minimum outer diameter of the catheter is 1.4 mm, with other commonly used sizes including a 0.34 mm guidewire and a 2 mm sheath. In some small blood vessels, the advancement of catheters and sheaths may affect thrombus filtration and collection, and may even cause scratches or other damage to the vessel wall.

[0014] Please see Figures 1-13 This invention provides a guide wire 100, which includes a wire shaft 1 and a wire tube 2. The wire tube 2 is sleeved on the outside of the wire shaft 1 and is at least partially movable relative to the wire shaft 1 along the axial direction.

[0015] The tubing 2 includes a main body 21 and an umbrella section 22. The main body 21 has a hollow cavity, and the spindle 1 is disposed within the hollow cavity. The umbrella section 22 has its proximal end connected to the distal end of the main body 21, and its distal end is fixedly connected to the spindle 1, with the spindle 1 fitted within it. By controlling the relative axial movement of the proximal ends of the spindle 1 and the tubing 2, the umbrella section 22 can be controlled to arch radially away from or approach the spindle 1, thus allowing it to be in an open or closed state. When the umbrella section 22 is in the open state, as... Figure 1 , Figure 5 , Figure 6 , Figure 8 and Figure 12 As shown, the umbrella portion 22 is used at least to filter blood clots; when the umbrella portion 22 is in the closed state, as... Figure 2 , Figure 7 and Figure 13 As shown, the umbrella section 22 is used at least for collecting blood clots.

[0016] Therefore, the guidewire 100 provided in this embodiment of the invention includes a tubing 2 and a spool 1. By controlling the relative axial movement of the proximal end of the spool 1 and the proximal end of the tubing 2, the umbrella portion 22 in the tubing 2 can be controlled to be in an expanded or closed state, thereby controlling the umbrella portion 22 to filter and collect thrombi. In this process, no catheter is required, thus reducing the harm to the patient caused by the catheter's advancement in the blood vessel during thrombus filtration and collection. Furthermore, due to the flexibility of the guidewire 100 itself, its movement in the blood vessel is more flexible and smooth. Moreover, the guidewire 100 can not only be used for filtering and collecting thrombi, but also as a guide for other medical devices' intravascular access in interventional procedures. This achieves a multi-purpose effect and saves the additional steps of the anti-embolism umbrella access, thereby reducing harm to the patient during interventional procedures.

[0017] Among them, such as Figure 1 , Figure 5 , Figure 6 , Figure 8 and Figure 12 As shown, when the umbrella part 22 is in the deployed state, the umbrella part 22 can filter blood clots like an umbrella; Figure 2 , Figure 7 and Figure 13 As shown, when the umbrella part 22 is in the closed state, the umbrella part 22 wraps and collects the filtered blood clots so that they can be taken out of the human body.

[0018] In some embodiments, the spool 1 is a single metal wire or formed by twisting several metal wires together, and the tube 2 is entirely a metal tube, but a fin 22 is formed at the distal end of the tube 2. The spool 1 and the tube 2 can also be made of other materials with a certain degree of rigidity. For example, both the spool 1 and the tube 2 can be made of 304 stainless steel. Further, in some embodiments, the tube 2 is coated with a PTFE coating to reduce friction during its travel in the blood vessel and increase its smoothness. The spool 1 may not have this coating.

[0019] In some embodiments, the outer diameter of the lead spool 1 is 0.20mm-0.89mm.

[0020] In some embodiments, the outer diameter of the wire tube 2 is 0.25mm-0.97mm.

[0021] Therefore, the guidewire 100 provided in this embodiment of the invention is thicker and stiffer than conventional guidewires, but much thinner and more flexible than conventional catheters or sheaths. In blood vessels, it not only possesses a certain rigidity to filter and encapsulate thrombi for thrombus recovery, but also allows for sufficiently flexible movement within the blood vessel. Thus, the guidewire 100 provided in this embodiment of the invention can not only filter and collect thrombi, but also has sufficient flexibility to serve as a guide for other medical devices entering blood vessels during interventional procedures.

[0022] Furthermore, in some embodiments, such as Figures 1-13 As shown, the guidewire 100 also includes a flexible tip 3, disposed at the distal end of the guidewire tube 2 or the guidewire spool 1. The flexible tip 3 includes an elastic portion 31 and a tip body portion (not shown), with the elastic portion 31 surrounding the tip body portion. Therefore, the elastic portion 31 surrounding the flexible tip 3 improves the flexibility of the guidewire tip 100, thereby reducing damage to the blood vessel wall caused by the tip of the guidewire 100 during insertion and travel.

[0023] Please see Figures 1-13 In some embodiments, the umbrella portion 22 includes at least two thin rods 221 and a first filter membrane 222. All thin rods 221 are spaced apart circumferentially, and the distal end of the thin rod 221 is fixedly connected to the spool 1. The proximal end of the thin rod 221 is connected to the main body portion 21. The first filter membrane 222 is provided with a plurality of first filter holes (not shown). The thin rod 221 includes a first rod body 2211, a flexible rod body 2212 and a second rod body 2213 arranged axially from the proximal end to the distal end. The first filter membrane 222 covers at least a portion of the first rod body 2211 or at least a portion of the second rod body 2213.

[0024] Initially, umbrella section 22 is in a closed state, as can be seen from [the previous description]. Figure 2 , Figure 7 and Figure 10 However, it is understandable that initially, when the umbrella portion 22 is closed, its folded outer diameter is smaller than its outer diameter when it encloses and collects thrombi because it does not contain any filtered thrombi. When the proximal end of the spool 1 moves axially relative to the proximal end of the tubing 2—for example, by pulling the proximal end of the spool 1 or pushing the proximal end of the tubing 2—the distal end of the umbrella portion 22 is fixed to the spool 1, meaning the distal end of the spool 1 and the distal end of the tubing 2 are relatively fixed. Furthermore, because the umbrella portion 22 on the tubing 2 has a flexible rod 2212, the tubing 2 is compressed, causing the flexible rod 2212 to bend. This causes the thin rod 221 to arch away from the spool 1. At this point, the umbrella portion 22 is in an unfolded state, forming an umbrella-shaped structure with an opening facing either the proximal or distal end to facilitate thrombi filtering. Figure 1 , Figure 5 , Figure 6 , Figure 8 and Figure 12 As shown.

[0025] When the proximal end of the spool 1 moves axially distally relative to the proximal end of the tubing 2—for example, by pushing the proximal end of the spool 1 or pulling the proximal end of the tubing 2—the umbrella section 22 returns to its closed state, and the filtered thrombus is collected in the cavity in the middle of the umbrella section 22, such as... Figure 2 , Figure 7 and Figure 13As shown. As long as the proximal ends of the control wire 1 and the control tube 2 no longer move relative to each other, the umbrella part 22 can be kept in a closed state, and the thrombus inside will not easily escape until the guide wire 100 and the thrombus are removed from the patient's body.

[0026] The proximal end of the wire shaft 1 extends beyond the proximal end of the wire tube 2 and is exposed outside the wire tube 2, so as to control the axial relative displacement of the wire shaft 1 and the wire tube 2 at the proximal end.

[0027] Furthermore, the first filter membrane 222 covers at least a portion of the first rod 2211 or at least a portion of the second rod 2213. When the first filter membrane 222 covers at least a portion of the first rod 2211, such as... Figure 1 , Figure 6 and Figure 8 As shown, the umbrella portion 22 facilitates the formation of an umbrella-shaped structure with an opening towards the distal end in the first rod 2211 to catch thrombi in the blood flow from the distal end to the proximal end; when the first filter membrane 222 covers at least a portion of the second rod 2213, as Figure 5 As shown, the umbrella portion 22 is advantageous in forming an umbrella-shaped structure with an opening facing the proximal end in the second rod 2213, so as to catch the thrombus in the blood flow from the proximal end to the distal end.

[0028] Furthermore, the first filter membrane 222 is provided with a plurality of first filter pores, which facilitates the first filter membrane 222 in filtering thrombi in the blood flow, allowing the thrombi in the blood flow to remain in the umbrella-shaped structure with the first filter membrane 222, while other substances in the blood flow can pass through the umbrella-shaped structure without being captured.

[0029] Furthermore, in some embodiments, such as Figure 3 and Figure 4 As shown, the thin rod 221 can be formed by cutting the distal end of the metal tube that forms the wire tube 2 as described above. Specifically, the thin rod 221 can be a long and thin rod, a serrated rod, a funnel-shaped rod, or a rod of other shapes that extends from the proximal end to the distal end along the axial direction of the wire tube 2. The shape of the thin rod 221 is not limited here.

[0030] Among them, the bendable rod 2212 is easier to bend or is the main bending part compared to the first rod 2211, the second rod 2213 and other parts of the wire tube 2, which is conducive to the umbrella part 22 arching away from the wire shaft 1.

[0031] like Figure 1 , Figure 5 , Figure 6 , Figure 8 and Figure 12 As shown, when the umbrella section 22 is in the unfolded state, each thin rod 221 arches away from the wire shaft 1, allowing the umbrella section 22 to filter blood clots like an umbrella; Figure 2, Figure 7 and Figure 13 As shown, when the umbrella part 22 is in the closed state, each thin rod 221 is attached to the direction close to the wire shaft 1, so that the umbrella part 22 wraps and collects the filtered blood clots, so as to carry them out of the human body.

[0032] The size of each first filter pore can be the same or different. In some embodiments, the size of the first filter pore is about 0.08 mm, which is beneficial for filtering most of the thrombi.

[0033] In some embodiments, the first filter membrane 222 may be made of a polymer film.

[0034] In some embodiments, the first filter membrane 222 covers the entire first rod 2211 or the second rod 2213, thereby maximizing the area that can contain the thrombus.

[0035] Please see Figures 1-8 In some embodiments, at least two adjacent thin rods 221 are connected by connecting rods 223, which are disposed in the area covered by the first filter membrane 222. Thus, by connecting adjacent thin rods 221 with connecting rods 223, when the umbrella portion 22 is in the deployed state, the connecting rods 223 can support the first filter membrane 222 between the thin rods 221, making the umbrella-shaped structure formed by the thin rods 221 more stable and thus more easily trapping thrombi. Furthermore, with the support of the connecting rods 223, the first filter membrane 222 can better adhere to the blood vessel wall, achieving a better thrombus filtration effect.

[0036] In some embodiments, the connecting rod 223 is a "Y"-shaped rod formed between adjacent thin rods 221. Further, as... Figure 4 As shown, in some embodiments, the upper end 223A of the "Y" shape of the connecting rod 223 can be cut into a wavy shape, thereby making the stretching and changing of the connecting rod 223 more flexible to match the shape of the first filter membrane 222 under different conditions. Furthermore, the upper end 223A of the "Y" shape of the connecting rod 223 can also be used as the boundary of the first filter membrane 222, thereby making the overall support of the first filter membrane 222 better.

[0037] Please see Figures 1-8 In some embodiments, in areas not covered by the first filter membrane 222, at least one thin rod 221 is sandblasted, and / or, as... Figures 5-6As shown, at least one thin rod 221 is covered by a thin filter membrane 224. Thus, after sandblasting, the sharp cutting edges of the thin rod 221's outline are removed. After being covered by the thin filter membrane 224, the thin rod 221 does not directly contact the blood vessel wall when the guidewire 100 is in the blood vessel, thereby reducing damage to the blood vessel wall from exposed metal. Simultaneously, when the umbrella section 22 collects the thrombus and returns to its closed state, the thin rod 221, along with the thin filter membrane 224, reattaches to the guidewire spool 1. Especially when the width of the thin filter membrane 224 is greater than the width of the thin rod 221, its relatively larger area makes it easier to block the opening of the umbrella-shaped structure, thus preventing the filtered thrombus from escaping and facilitating thrombus collection.

[0038] The elongated filter membrane 224 can be elongated strips, with its edges in the width direction being straight, serrated, stepped, or other shapes, extending from the proximal end to the distal end. In some embodiments, the edges of the elongated filter membrane 224 in the width direction are serrated or stepped, and the serrated or stepped edges of adjacent elongated filter membranes 224 can fit or engage with each other, so that when the umbrella portion 22 is in the closed state, the elongated filter membranes 224 aggregate and fit or engage together to block the opening of the umbrella-shaped structure and prevent thrombus escape. It should be noted that because the elongated filter membrane 224 is very soft, even if it is serrated or stepped, it will not damage blood vessels. In some embodiments, the elongated filter membrane 224 is made of a polymer film.

[0039] In some embodiments, the bendable rod 2212 is made of a hyperelastic material and shaped into a curved form, and / or the width of the bendable rod 2212 is smaller than the width of the first rod 2211 and the second rod 2213. Therefore, the bendable rod 2212 being made of a hyperelastic material and shaped into a curved form allows the umbrella 22 to achieve an ideal bending effect when in the unfolded state. Furthermore, because the width of the bendable rod 2212 is smaller than the width of the first rod 2211 and the second rod 2213, the bendable rod 2212 experiences less bending stress compared to the first rod 2211 and the second rod 2213, making it easier to bend and ensuring that the umbrella 22 achieves an ideal bending effect when in the unfolded state.

[0040] Understandably, the bendable rod 2212 is made of a hyperelastic material and is shaped into a bend. When the umbrella part 22 is in the closed state, the bendable rod 2212 is straightened by keeping the proximal end of the spool 1 and the proximal end of the tube 2 fixed relative to each other. When the proximal end of the spool 1 moves axially towards the proximal end relative to the proximal end of the tube 2—for example, by pulling the proximal end of the spool 1 or pushing the proximal end of the tube 2—the bendable rod 2212 gradually returns to its shaped bend. When the proximal end of the spool 1 moves axially towards the distal end relative to the proximal end of the tube 2—for example, by pushing the proximal end of the spool 1 or pulling the proximal end of the tube 2—the bendable rod 2212 is further straightened, and the umbrella part 22 returns to the closed state.

[0041] In some embodiments, the bendable rod 2212 is made of a hyperelastic material and shaped into a bend, which includes at least one arc-shaped bend.

[0042] Please see Figure 4 and Figure 7 In some embodiments, in the area not covered by the first filter membrane 222, the first rod 2211 or the second rod 2213 is made of a hyperelastic material and shaped into a spiral. This results in the first rod 2211 or the second rod 2213, made of hyperelastic material and shaped into a spiral, being spirally attached to the vicinity of the spool 1 when the umbrella part 22 is in the closed state. It can be understood that at this time, the first rod 2211 or the second rod 2213, made of hyperelastic material and shaped into a spiral, is in a naturally shaped state. When the proximal end of the spool 1 moves axially relative to the proximal end of the tube 2—for example, by pulling the proximal end of the spool 1 or pushing the proximal end of the tube 2—the relative angle between the proximal ends of the spool 1 and the tube 2 rotates simultaneously. The force applied to the proximal ends of the spool 1 and the tube 2 forces the first rod 2211 or the second rod 2213, which was originally spirally attached to the vicinity of the spool 1, to unfold and arch away from the spool 1 along with the flexible rod 2212. Figure 1 , Figure 6 and Figure 8 As shown, it can be understood that at this time, the first rod 2211 or the second rod 2213, made of hyperelastic material and shaped into a spiral, is in a stretched state; and when the proximal end of the wire shaft 1 moves axially towards the distal end relative to the proximal end of the wire tube 2—for example, by pushing the proximal end of the wire shaft 1 or pulling the proximal end of the wire tube 2—the first rod 2211 or the second rod 2213, made of hyperelastic material and shaped into a spiral, further returns to a spiral shape and adheres to the vicinity of the wire shaft 1, such as... Figure 7As shown, it can be understood that the first rod 2211 or the second rod 2213, made of superelastic material and shaped into a spiral, returns to its natural, shaped state. The spiral shape of the first rod 2211 or the second rod 2213, attached to the vicinity of the wire shaft 1, makes it easier to block the opening of the umbrella-shaped structure, thus preventing the thrombus filtered by the umbrella-shaped structure from escaping through the opening and facilitating thrombus collection.

[0043] Please see Figures 7-8 In some embodiments, at least in the area not covered by the first filter membrane 222, at least the portion of the flexible rod 2212 that is connected to the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spool 1 via a connecting membrane 225.

[0044] It includes at least two conditions: The first condition is that, at least a portion of the thin rod 221 is connected to the spool 1 via the connecting membrane 225, at least in the area not covered by the first filter membrane 222. For example, at least a portion of the thin rod 221 is connected to the spool 1 via the connecting membrane 225 not only in the area not covered by the first filter membrane 222, but also in the area covered by the first filter membrane 222; or, at least a portion of the thin rod 221 is connected to the spool 1 via the connecting membrane 225 only in the area not covered by the first filter membrane 222.

[0045] The second condition is that at least the portion of the flexible rod 2212 in the thin rod 221 that is connected to the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spool 1 through the connecting membrane 225. That is, at least the connection point of the flexible rod 2212 to the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spool 1 through the connecting membrane 225. For example, when the first filter membrane 222 covers at least a portion of the first rod 2211, the connection point of the flexible rod 2212 to the first rod 2211 is connected to the spool 1 through the connecting membrane 225.

[0046] Therefore, in this embodiment, it can be understood that, for example, when the first filter membrane 222 covers at least a portion of the first rod 2211, the entire flexible rod 2212 and the second rod 2213 can be connected to the spool 1 via the connecting membrane 225; alternatively, the flexible rod 2212 and the second rod 2213 can be connected to the spool 1 via the connecting membrane 225, and at least a portion of the first rod 2211 near the flexible rod 2212 is connected to the spool 1 via the connecting membrane 225, such as... Figure 8 As shown; alternatively, only the portion of the bendable rod 2212 closest to the first rod 2211 can be connected to the spindle 1 via the connecting membrane 225. Specific configurations of the connecting membrane 225 are not listed individually.

[0047] Therefore, by ensuring that at least the connection point between the flexible rod 2212 and the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spindle 1 via the connecting membrane 225, when the umbrella part 22 is in the closed state, at least the portion of the flexible rod 2212 attached to the spindle 11 that is connected to the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spindle 1 via the connecting membrane 225. This causes the connecting membrane 225 to accumulate at the opening of the umbrella-shaped structure, thereby easily blocking the opening of the umbrella-shaped structure. Consequently, the thrombus filtered by the umbrella-shaped structure is less likely to escape from the opening, which is beneficial for thrombus collection. It can be understood that, based on this, at least in the area not covered by the first filter membrane 222, the more areas of the thin rod 221 connected to the spindle 1 via the connecting membrane 225, the better the effect of blocking the opening of the umbrella-shaped structure, and thus the better the effect of preventing thrombus escape.

[0048] Especially in areas not covered by the first filter membrane 222, when the first rod 2211 or the second rod 2213 is made of a hyperelastic material and shaped into a spiral, and at least the portion of the bendable rod 2212 connected to the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the spool 1 via a connecting membrane 225, the connecting membrane 225 spirally winds around the spool 1 along with the spiral first rod 2211 or the second rod 2213, such as... Figure 7 As shown, this can further improve the effect of blocking the opening of the umbrella-shaped structure, thereby making it more difficult for the thrombus filtered by the umbrella-shaped structure to escape from the opening, which is beneficial for thrombus collection.

[0049] Among them, such as Figure 8 As shown, in some embodiments, at least a portion of the thin rod 221 is connected to a corresponding projected portion on the wire spool 1 via a connecting membrane 225; further, each thin rod 221 is connected to the wire spool 1 via the connecting membrane 225. In some embodiments, for better sealing effect, the connecting membrane 225 extends radially.

[0050] In some embodiments, the connecting membrane 225 is a polymer film.

[0051] In order to ensure that the connecting membrane 225 can be folded better, when pushing the proximal end of the wire shaft 1 or pulling the proximal end of the wire tube 2, the axial relative movement of the proximal ends of the wire shaft 1 and the wire tube 2 can be controlled at the same time, and the circumferential relative rotation of the two can be controlled at the same time, so that the connecting membrane 225 can be better wound around the wire shaft 1.

[0052] like Figure 9As shown, in some embodiments, in the area covered by the first filter membrane 222, the first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the wire shaft 1 through a connecting membrane 225. The first rod 2211 or the second rod 2213 covered by the first filter membrane 222 is connected to the wire shaft 1 through several spaced connecting membranes 225. This allows the spaced connecting membranes 225 to cut the collected thrombus when the umbrella-shaped structure of the umbrella portion 22 filters the thrombus and returns to the closed state. This results in the volume of some thrombi with larger outer diameters being cut within the cavity covered by the first filter membrane 222. Consequently, the volume of the thrombus after being covered by the first filter membrane 222 is more uniform and not too large, which is beneficial for the guide wire 100 and the thrombus to be carried out of the human body.

[0053] Please see Figures 10-13 In some embodiments, the umbrella portion 22 further includes a second filter membrane 226, which covers the area of ​​the thin rod 221 not covered by the first filter membrane 222. The second filter membrane 226 has a plurality of second filter holes 226A. This ensures that the thin rod 221 on the umbrella portion 22 is completely covered by the first filter membrane 222 and the second filter membrane 226, so that when the proximal end of the spool 1 moves axially relative to the proximal end of the tube 2—for example, by pulling the proximal end of the spool 1 or pushing the proximal end of the tube 2—the thin rod 221 arches away from the spool 1. Figure 10 The closed state shown is transformed to, for example, Figure 11 In the unfolded state shown, because the thin rod 221 is completely covered by the first filter membrane 222 and the second filter membrane 226, the umbrella-shaped structure formed by the thin rod 221 is not very effective at filtering thrombi. If the proximal end of the wire spool 1 is pulled or the proximal end of the wire tube 2 is pushed, both the first rod 2211 and the second rod 2213 will form umbrella-shaped structures facing the same direction and overlap. This allows the first filter membrane 222 and the second filter membrane 226 to form a double-layered umbrella-shaped structure to filter thrombi. Figure 12 As shown, the umbrella section 22 can also be considered as being in an unfolded state at this time; furthermore, the proximal end of the wire shaft 1 can be pulled or the proximal end of the wire tube 2 can be pushed, so that the umbrella-shaped structure formed by the first rod 2211 and the second rod 2213 moves closer to the wire shaft 1, as shown. Figure 13 As shown, this allows the thrombus to be contained and collected until it is removed from the patient's body. At this point, the umbrella section 22 can also be considered as closed. It is important to understand that when the first filter membrane 222 and the second filter membrane 226 form a double-layered umbrella-shaped structure, the second filter membrane 226 is located on the inner side and the first filter membrane 222 is located on the outer side. Their openings face the same direction and are directed towards the direction of blood flow, that is, their openings are opposite to the direction of blood flow.

[0054] It should be noted that, Figure 13In the middle, the original umbrella-shaped structure of the umbrella part 22 is the part that moves towards its center and is attached to the wire tube 2 further away from the second rod 2213, thereby preventing the thrombus from escaping from the opening.

[0055] Furthermore, in some embodiments, the pore size of the first filter pore is smaller than that of the second filter pore 226A. This allows the second filter pore 226 to first filter larger thrombi and retain them within its cavity when blood flows through the double-layered umbrella-like structure formed by the first filter membrane 222 and the second filter membrane 226. The first filter membrane 222 then filters smaller thrombi and retains them within the cavity formed by the first filter membrane 222 and the second filter membrane 226. This ensures that thrombi of different sizes are layered axially and radially, preventing them from stacking on the same cross-section. This prevents the first and second filter membranes from encapsulating thrombi with excessively large outer diameters, making it difficult for them to travel within the blood vessel or even withdraw from it.

[0056] Wherein, when the diameter of the first filter hole is smaller than the diameter of the second filter hole 226A, even if the umbrella part 22 is in such a state... Figure 11 In the unfolded state shown, because the second filter pore 226A is larger, it can still allow some thrombi with smaller outer diameters to pass through, allowing these smaller thrombi to enter the cavity formed by the first filter membrane 222 and the second filter membrane 226, thus achieving a certain effect of filtering thrombi. When the umbrella portion 22 is in the unfolded state... Figure 12 In the unfolded state shown, the first filter membrane 222 and the second filter membrane 226 form a double-layered umbrella-like structure that can filter not only thrombi with smaller outer diameters but also thrombi with larger outer diameters. Furthermore, when the umbrella portion 22 is in the position shown... Figure 13 When in the closed state shown, the filtered and collected thrombi can be layered in a certain way in the axial and radial directions, thereby preventing thrombi of different sizes from stacking on the same cross section.

[0057] The size of each second filter hole 226A may be the same or different.

[0058] like Figures 11-13 As shown, the second rod 2213 includes a first end 2213A and a second end 2213B that are axially opposite each other, wherein the first end 2213A is connected to the flexible rod 2212.

[0059] Please see Figure 11In some embodiments, the pore size of the second filter hole 226A near the first end 2213A on the second filter membrane 226 is smaller than the pore size of the second filter hole 226A near the second end 2213B. The larger pore size of the second filter hole 226A near the second end 2213B on the second filter membrane 226 facilitates the entry of a thrombus into the space formed by the first filter membrane 222 and the second filter membrane 226, while the smaller pore size of the second filter hole 226A near the first end 2213A on the second filter membrane 226 prevents the umbrella portion 22 from being in a position similar to... Figure 13 The thrombus encapsulated in the closed state shown escapes. Specifically, the second filter pore 226A on the second filter membrane 226, near the first end 2213A, has a smaller diameter, allowing blood flow while preventing most thrombi from passing through. This not only facilitates smoother blood flow into the second filter membrane 226 but also allows the umbrella portion 22 to be positioned as... Figure 13 When closed, it prevents the thrombus filtered and collected by the second filter membrane 226 from passing through, thereby preventing the thrombus from escaping from the opening of the umbrella-shaped structure.

[0060] It should be noted that, Figure 11 In this paper, only a portion of the second filter pore 226A is shown to facilitate the reader's understanding of the relevant technical solutions of this application. However, it is understood that the second filter pore 226A may cover most of the area of ​​the second filter membrane 226.

[0061] Furthermore, in some embodiments, such as Figure 11 As shown, the second filter membrane 226 covering the area of ​​the flexible rod 2212 does not have a second filter hole 226A. When the umbrella part 22 is in the position of... Figure 13 In the closed state shown, since the flexible rod 2212 and the second filter membrane 226 covering its area are exposed in the blood vessel, the second filter membrane 226 covering the area of ​​the flexible rod 2212 does not have a second filter hole 226A. This prevents the collected thrombus from escaping from the second filter membrane 226 covering the area of ​​the flexible rod 2212. Furthermore, since the umbrella portion 22 is in the closed state as shown... Figure 11 and Figure 12 In its unfolded state, the second filter membrane 226 covering the area of ​​the flexible rod 2212 is nearly parallel to the blood flow direction, so even if it does not have a second filter hole 226A, it will not affect the smooth flow of blood. It should be noted that the second filter membrane 226 covering the area of ​​the flexible rod 2212 refers to the second filter membrane 226 covering the area enclosed by the flexible rod 2212. For example, it can be the second filter membrane 226 covering the entire circumference of the flexible rod 2212, rather than the second filter membrane 226 covering only the area of ​​the flexible rod 2212.

[0062] Furthermore, in some embodiments, such as Figures 11-13As shown, the first filter membrane 222 covers at least a portion of the first rod 2211. This can be understood as the opening of the umbrella-shaped structure in the umbrella portion 22 facing the distal end. The first length from the distal end of the filament 2 to the second end 2213B of the second rod 2213 is greater than the length of the second rod 2213, and the length of the first rod 2211 is greater than the length of the second rod 2213. Therefore, the first length from the distal end of the filament 2 to the distal end of the second rod 2213 is greater than the length of the second rod 2213, which allows the portion of the filament 2 extending beyond the second rod 2213 to block the opening of the double-layered umbrella structure after the double-layered umbrella structure formed by the first filter membrane 222 and the second filter membrane 226 approaches and folds towards the filament shaft 1, thus preventing thrombi from escaping from the opening of the double-layered umbrella structure. Furthermore, the greater length of the first rod 2211 than the second rod 2213 facilitates better folding of the double-layered umbrella structure formed by the first filter membrane 222 and the second filter membrane 226.

[0063] In other embodiments, the first filter membrane 222 covers at least a portion of the second rod 2213. In this case, it can be understood that the opening of the umbrella-shaped structure in the umbrella portion 22 faces proximal to the first rod 2211, and the length of the second rod 2213 is greater than the length of the first rod 2211. Therefore, the greater length of the second rod 2213 facilitates better folding of the double-layered umbrella-shaped structure formed by the first filter membrane 222 and the second filter membrane 226. It is conceivable that when the first filter membrane 222 covers at least a portion of the second rod 2213, the opening of the double-layered umbrella-shaped structure formed by the first filter membrane 222 and the second filter membrane 226 faces proximal to the first rod 2211. When the double-layered umbrella-shaped structure forms with the first filter membrane 222 and the second filter membrane 226 and moves closer to and folds towards the filament 1, the proximal end of the filament 2 is close to the patient's body, significantly extending beyond the first rod 2211. Therefore, it can block the opening of the double-layered umbrella-shaped structure, thereby preventing thrombi from escaping from the opening of the double-layered umbrella-shaped structure.

[0064] In some embodiments, to ensure that the first filter membrane 222 and / or the second filter membrane 226 can be folded in a predetermined order after the umbrella portion 22 has filtered the thrombus and returned to its closed state, and instead of becoming disordered and wrinkled, hot stamping can be applied to the surface of the first filter membrane 222 and / or the second filter membrane 226 to create certain preset creases. This allows the first filter membrane 222 and / or the second filter membrane 226 to be folded in an orderly manner along the preset creases. Simultaneously, these preset creases also prevent the first filter membrane 222 and / or the second filter membrane 226 from being excessively deformed by the thin rod 221 when the umbrella portion 22 is in the unfolded state.

[0065] As previously stated, the bendable rod 2212 is made of a hyperelastic material and shaped into a bend, and / or the width of the bendable rod 2212 is smaller than the widths of the first rod 2211 and the second rod 2213. Therefore, in Figures 11-13In the illustrated embodiment, to achieve the desired bending effect of the flexible rod 2212, the flexible rod 2212 is made of a superelastic material, and the flexible rod 2212 can be positioned such that the umbrella part is in the unfolded state capable of filtering blood clots (e.g., Figure 12 (as shown) or the closure state of the thrombus that can be collected (e.g.) Figure 13 The degree of bending is shaped to ensure that when the proximal end of the control wire spool 1 and the proximal end of the control wire tube 2 move axially relative to each other, the opening of the umbrella-shaped structure in the umbrella part can unfold in the expected direction to filter and collect thrombi.

[0066] Alternatively, in the flexible rod 2212, if the bending effect of the flexible rod 2212 is to achieve an ideal state so that the opening of the umbrella-shaped structure in the umbrella part faces the far end, then the width of the first rod 2211 is larger than the width of the second rod 2213, and the width of the second rod 2213 is larger than the width of the flexible rod 2212. Among these, the width of the flexible rod 2212 is the smallest, which is conducive to the flexible rod 2212 bending to a larger extent compared with the first rod 2211 and the second rod 2213. The width of the first rod 2211 is larger than the width of the second rod 2213, which is conducive to the first rod 2211 eventually wrapping around the second rod 2213 and being located outside the second rod 2213 during the process of controlling the relative axial movement of the proximal end of the wire shaft 1 and the proximal end of the wire tube 2, thereby making the opening of the umbrella-shaped structure in the umbrella part face the far end. Furthermore, the width of the rod from the farthest end of the wire tube 2 to the second end 2213B of the second rod 2213 is greater than the width of the second rod 2213, thereby ensuring that when the umbrella part is in such a position... Figure 13 In the closed state shown, the rod from the farthest end of the wire tube 2 to the second end 2213B of the second rod 2213 has sufficient rigidity and width to block the opening of the umbrella-shaped structure.

[0067] Similarly, if the bending effect of the flexible rod 2212 is to achieve an ideal state so that the opening of the umbrella-shaped structure in the umbrella part faces the proximal end, then the width of the second rod 2213 is larger than the width of the first rod 2211, and the width of the first rod 2211 is larger than the width of the flexible rod 2212. This ensures that during the relative axial movement of the proximal end of the control wire shaft 1 and the proximal end of the wire tube 2, the opening of the umbrella-shaped structure in the umbrella part faces the proximal end.

[0068] Furthermore, in some embodiments, a sealing block (not shown) is also provided at the distal end of the wire tube 2, which is sleeved on the wire tube 2 and located when the umbrella part 22 is in the position of... Figure 13 When the umbrella portion 22 is in the unfolded state, the distal end of the opening of the umbrella-shaped structure is visible, thereby enabling the sealing block to seal the opening of the umbrella-shaped structure to prevent thrombus escape.

[0069] It is understood that the above specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention. This specification cannot exhaustively describe all embodiments of the present invention concept, and some features of the different embodiments described above can be substituted for or combined with each other. Those skilled in the art can also make simple substitutions according to actual needs. The concept of the present invention is subject to the claimed protection scope.

Claims

1. A guidewire, characterized in that, The guidewire includes: Lead spool; and A wire tube is sleeved on the outside of the wire shaft and is at least partially movable axially relative to the wire shaft; The wire tube includes: The main body includes a hollow cavity, in which the spool is disposed; and The umbrella part has its proximal end connected to the distal end of the main body part. The distal end of the umbrella part is fixedly connected to the spool, and the spool is sleeved in the umbrella part. By controlling the relative axial movement of the proximal end of the spool and the proximal end of the tube, the umbrella part can be controlled to arch away from the spool in the radial direction or to move closer to the spool, thereby making the umbrella part in an open or closed state. Wherein, when the umbrella part is in the unfolded state, the umbrella part is used at least to filter blood clots; when the umbrella part is in the closed state, the umbrella part is used at least to collect blood clots.

2. The guidewire according to claim 1, characterized in that, The umbrella part includes at least two thin rods and a first filter membrane. All the thin rods are arranged circumferentially, and the distal end of the thin rod is fixedly connected to the spool. The proximal end of the thin rod is connected to the main body. The first filter membrane is provided with a plurality of first filter holes. The thin rod includes a first rod body, a flexible rod body, and a second rod body arranged axially from the proximal end to the distal end, wherein the first filter membrane covers at least a portion of the first rod body or at least a portion of the second rod body.

3. The guidewire according to claim 2, characterized in that, At least two adjacent thin rods are connected by a connecting rod disposed in the area covered by the first filter membrane.

4. The guidewire according to claim 2, characterized in that, In the area not covered by the first filter membrane, at least one of the rods is sandblasted, and / or at least one of the rods is covered by an elongated filter membrane.

5. The guidewire according to claim 2, characterized in that, The bendable rod is made of a superelastic material and shaped into a bend, and / or the width of the bendable rod is smaller than the width of the first rod and the second rod.

6. The guidewire according to claim 2, characterized in that, In the area not covered by the first filter membrane, the first rod or the second rod is made of a hyperelastic material and shaped into a spiral.

7. The guidewire according to claim 2, characterized in that, At least in the area not covered by the first filter membrane, at least the portion of the flexible rod that connects to the first rod or the second rod covered by the first filter membrane is connected to the spool via a connecting membrane; and / or, in the area covered by the first filter membrane, the first rod or the second rod covered by the first filter membrane is connected to the spool via several spaced connecting membranes.

8. The guidewire according to claim 3, characterized in that, The umbrella section also includes a second filter membrane, which covers the area of ​​the thin rod not covered by the first filter membrane, and the second filter membrane is provided with a plurality of second filter holes.

9. The guidewire according to claim 8, characterized in that, The second rod includes a first end and a second end that are axially opposite each other, wherein the first end is connected to the flexible rod; the first filter membrane covers at least a portion of the first rod, and the first length from the farthest end of the filament to the second end of the second rod is greater than the length of the second rod, and the length of the first rod is greater than the length of the second rod; or, the first filter membrane covers at least a portion of the second rod, and the length of the second rod is greater than the length of the first rod.

10. The guidewire according to claim 8, characterized in that, The diameter of the first filter pore is smaller than the diameter of the second filter pore; and / or, the diameter of the second filter pore near the first end on the second filter membrane is smaller than the diameter of the second filter pore near the second end, wherein the second rod includes a first end and a second end that are axially opposite each other, wherein the first end is connected to the flexible rod.

11. The guidewire according to claim 8, characterized in that, The first filter membrane covers at least a portion of the first rod, the width of the first rod being greater than the width of the second rod, and the width of the second rod being greater than the width of the flexible rod; or, the first filter membrane covers at least a portion of the first rod, the width of the second rod being greater than the width of the first rod, and the width of the first rod being greater than the width of the flexible rod.

12. The guidewire according to claim 1, characterized in that, The guidewire also includes a flexible tip disposed at the distal end of the wire tube or the wire spool. The flexible tip includes an elastic portion and a tip body portion, with the elastic portion surrounding the outside of the tip body portion.

13. The guidewire according to claim 1, characterized in that, The guidewire is used to provide a guiding path for medical devices in interventional surgery, and the outer diameter of the guidewire spool is 0.20mm-0.89mm, and / or the outer diameter of the guidewire tube is 0.25mm-0.97mm.

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