Nicking guide wire, nicking balloon assembly and intervention device

Abstract

The invention provides a nicking guide wire, a nicking balloon assembly and an intervention device. The nicking guide wire comprises a guide wire shaft and a cutting unit. The cutting unit has an expansion state and a compression state, the far end of the cutting unit is fixed to the guide wire shaft, and the near end of the cutting unit is of an expandable annular structure. The nick guide wire is configured such that when the nick guide wire cooperates with the balloon catheter, at least part of the distal end of the balloon catheter enters the interior of the cutting unit through the annular structure. The indented guide wire is provided with the cutting unit, the cutting unit is combined with a balloon catheter to achieve the balloon cutting function, due to the fact that the indented guide wire is separated from a balloon body, the trafficability and flexibility of the product are better than those of products such as a cutting balloon, and when the indented guide wire is applied to treatment of intracranial vessel moderate calcification lesions, blood vessel injuries are not likely to be caused; and operative complications are reduced. For serious calcification lesions of cardiovascular and peripheral blood vessels, plaque expansion can be achieved without additionally using a CTO balloon for pre-expansion, and the operation cost and the operation difficulty are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a scored guidewire, a scored balloon assembly and an interventional device. Background Art

[0002] Arterial calcification rates generally increase with age, with an incidence of approximately 80% in people aged 60-69. The greater the degree of arterial stenosis, the greater the probability of calcification. Atherosclerosis can lead to increased vascular stiffness and decreased compliance, posing a significant threat to human health. Percutaneous interventional surgery can quickly open blocked blood vessels, improve blood supply, and achieve reperfusion of ischemic myocardium, cerebral vessels, and peripheral blood vessels. It is effective in treating coronary heart disease, stroke, and peripheral vascular diseases. As a commonly used method of vascular reconstruction, vascular interventional therapy offers advantages such as high patency rates and ideal results.

[0003] Currently, conventional working balloons can treat superficial calcified lesions, but have a low success rate and high complication rate for moderately calcified lesions. The scored balloon (also known as a cutting balloon) currently on the market is based on the conventional working balloon and is more suitable for treating moderately calcified vessels.

[0004] For severely calcified lesions, such as chronic total occlusion (CTO) lesions, even if a guidewire can pass through the lesion, the larger cross-section of existing scored balloons (also known as cutting balloons) prevents them from following the guidewire through the lesion. Pre-dilation with specialized balloons (such as CTO balloons) is generally required before the scored balloon can be used, increasing surgical cost and difficulty. Furthermore, due to the larger cross-section of the scored balloon, the push resistance to intracranial vessels (including the vertebral artery) is high due to the tortuous vascular path. Consequently, no scored balloons suitable for intracranial vessels are currently commercially available. The larger cross-section of existing scored balloons also makes them less passable and less flexible than conventional balloons, making them more susceptible to vascular damage and surgical complications, which can be life-threatening in severe cases.

[0005] It should be noted that the information disclosed in the above background technology section is only used to enhance the understanding of the background of the present invention, and therefore may include information that does not constitute prior art known to ordinary technicians in this field. Summary of the Invention

[0006] In response to the problems in the prior art, the purpose of the present invention is to provide a scored guidewire, a scored balloon assembly and an interventional device. The preparation process of the scored guidewire is simple and convenient, easy to operate, suitable for a variety of blood vessels and multi-purpose, especially suitable for tortuous or narrow blood vessels, avoiding the problems of insufficient permeability and flexibility of the cutting balloon in the prior art.

[0007] A first aspect of the present invention provides a scored guidewire, comprising a guidewire shaft and a cutting unit disposed around a distal end of the guidewire shaft; The cutting unit has an expanded state and a compressed state, the distal end of the cutting unit is fixed to the guide wire shaft, and the proximal end of the cutting unit is an expandable ring structure; The scoring guidewire is configured such that, when the scoring guidewire is engaged with the balloon catheter, at least a portion of the distal end of the balloon catheter passes through the annular structure and enters the interior of the cutting unit.

[0008] According to the first aspect of the present invention, the scored guidewire further comprises a guide block and a limiter provided on the guidewire shaft; The limiting member is fixed to the guide wire shaft and is located on the proximal side of the cutting unit; The guide block is configured to be reciprocally movable between the limiting member and the distal end of the cutting unit, and when moving, the guide block passes through the annular structure and enters the cutting unit.

[0009] According to the first aspect of the present invention, the maximum outer diameter of the limiting member is greater than the minimum inner diameter of the guide block.

[0010] According to the first aspect of the present invention, the cutting unit includes a plurality of scoring wires, the distal ends of the plurality of scoring wires are fixedly connected to the guide wire shaft, and the proximal ends of the plurality of scoring wires are provided with the annular structure. When the cutting unit is in the compressed state, the annular structure is sleeved on at least part of the outer circumference of the guide block.

[0011] According to the first aspect of the present invention, each of the scoring wires comprises a plurality of wires; and / or The cross section of the scored wire is triangular, rectangular, trapezoidal or other polygonal, and / or The plurality of scored wires are in a spiral structure, a parallel arrangement structure or a grid structure; and / or The plurality of scoring wires are obtained by a laser cutting integral molding process or are formed into the cutting unit by weaving; and / or The material of the scoring wire is nickel-titanium alloy or nickel-titanium composite material, and the plurality of scoring wires are formed into the compressed state through a heat setting process.

[0012] According to the first aspect of the present invention, the annular structure is composed of a plurality of corrugated metal rods connected end to end.

[0013] According to the first aspect of the present invention, the guide block comprises a circular ring segment, a diameter-reducing segment and an abutting segment in sequence from the distal end to the proximal end, and the diameter of the diameter-reducing segment gradually increases in the direction from the distal end to the proximal end.

[0014] According to the first aspect of the present invention, the guide block is made of a developing material; and / or The limiting component is made of developing material.

[0015] According to the first aspect of the present invention, the cutting unit includes a helical coil structure helically bent around the guide wire shaft, and the helical coil structure and the guide wire shaft are integrally made of the same wire material.

[0016] According to the first aspect of the present invention, the material of the spiral coil structure includes nickel-titanium alloy or nickel-titanium composite material, and the spiral coil structure is formed by heat setting pre-shaping.

[0017] A second aspect of the present invention provides a scored balloon assembly, comprising the scored guidewire according to the first aspect of the present invention and a balloon catheter, wherein the balloon catheter is configured to be sleeved on the guidewire shaft of the scored guidewire and movable along the guidewire shaft; The balloon catheter comprises an inner lumen tube, an outer tube and a balloon body, wherein the distal end of the inner lumen tube passes through the balloon body, the distal end of the balloon body is connected to the distal end of the inner lumen tube, and the outer tube is connected to the proximal end of the balloon body and is sheathed outside the inner lumen tube; When the balloon enters the interior of the cutting unit through the annular structure and is pressurized, the cutting unit of the scoring guidewire is in an expanded state; when the balloon is depressurized, the cutting unit is in a compressed state.

[0018] According to a second aspect of the present invention, the scored guidewire further comprises a guide block and a limiter sleeved on the guidewire shaft; The limiting member is fixed to the guide wire shaft and is located on the proximal side of the cutting unit; The guide block is configured to be reciprocally movable between the limiting member and the distal end of the cutting unit, and when moving, the guide block passes through the annular structure and enters the cutting unit; When the balloon catheter moves distally relative to the notched guidewire, the distal end of the balloon catheter passes over the stopper and abuts against the proximal end of the guide block.

[0019] According to the second aspect of the present invention, the inner diameter of the inner lumen at the distal end of the balloon catheter is larger than the maximum outer diameter of the limiter and smaller than the maximum outer diameter of the guide block, and the distal end of the balloon catheter is tightly matched with the proximal end of the guide block.

[0020] The third aspect of the present invention provides an interventional device, which includes a guide catheter, a balloon catheter and the scored guidewire described in the first aspect of the present invention, wherein the scored guidewire and the balloon catheter are movably arranged in the guide catheter, and the balloon catheter is sleeved on the scored guidewire and movable along it.

[0021] According to a third aspect of the present invention, the guide catheter comprises a delivery section at one end and a recovery section at the other end, the delivery section has a lower hardness than the recovery section, and the free end of the recovery section has a flared structure.

[0022] The scoring guidewire of the present invention is provided with a cutting unit, which can realize the function of a cutting balloon when used in conjunction with a balloon catheter. Since the scoring guidewire of the present application does not include a balloon body itself, the passability and flexibility of the product are better than those of products such as scoring balloons or cutting balloons, and it is easier to pass through and treat moderate or above calcified lesions. When used to treat small and tortuous blood vessels such as intracranial blood vessels, it is not easy to cause vascular damage, thereby reducing surgical complications. For severe calcified lesions of cardiovascular and peripheral blood vessels, there is no need to use an additional CTO balloon for pre-expansion to achieve expansion of the plaque, thereby reducing surgical costs and difficulty. The preparation process of the scoring guidewire of the present invention is simple and convenient, easy to operate, and applicable to a variety of blood vessels and multiple uses. It avoids the problem of insufficient passability and flexibility of cutting balloons in the prior art, and significantly improves the safety and ease of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The drawings herein are incorporated into and constitute a part of the specification, illustrating embodiments consistent with the present application, and together with the specification, are used to explain the principles of the present application. By reading the detailed description of the non-limiting embodiments with reference to the following drawings, other features, purposes and advantages of the present invention will become more apparent. Obviously, the drawings described below are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work. In addition, the drawings are only schematic illustrations of the present disclosure and are not necessarily drawn to scale. The same figure numbers in the figures represent the same or similar parts, and their repeated descriptions will be omitted. Some of the block diagrams shown in the drawings are functional entities and do not necessarily correspond to physically or logically independent entities.

[0024] Figure 1 This is a schematic structural diagram of a scored guidewire according to a first embodiment of the present invention; Figure 2 Schematic diagram of the structure of the cutting unit of the scoring guidewire according to the first embodiment of the present invention; Figure 3 Schematic diagram of the structure of the guide block of the notched guide wire according to the first embodiment of the present invention; Figure 4 This is a schematic structural diagram of a scored guidewire according to a second embodiment of the present invention; Figure 5 This is a schematic structural diagram of a scored guidewire according to a third embodiment of the present invention; Figures 6 to 8 Schematic diagram of the structure of the scored balloon assembly in various states according to one embodiment of the present invention; Figure 9 A partial structural diagram of an interventional device according to an embodiment of the present invention; and Figure 10 Schematic diagram of the structure of a guide catheter of an interventional device according to one embodiment of the present invention. DETAILED DESCRIPTION

[0025] Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be embodied in many forms and should not be construed as limited to the examples set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the concepts of the example embodiments to those skilled in the art. The described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0026] Throughout this specification, reference to terms such as "one embodiment," "some embodiments," "examples," "specific examples," or "some examples" means that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this specification. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, those skilled in the art may combine and integrate different embodiments or examples, and features of different embodiments or examples, described in this specification, unless otherwise mutually incompatible.

[0027] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include at least one such feature. Throughout this specification, "plurality" means two or more, unless otherwise specifically defined.

[0028] Throughout this specification, when a device is said to be "connected" to another device, this includes not only "direct connection" but also "indirect connection" with other elements interposed therebetween. Furthermore, when a device is said to "include" a certain component, unless otherwise stated, this does not exclude the inclusion of other components but rather implies that the device may include other components.

[0029] Spatially relative terms such as "below" and "above" may be used to more easily explain the relationship of one device to another in the drawings. These terms refer not only to the device in the drawings but also to other aspects of the device during use or operation. For example, if a device in a drawing is turned over, a device previously described as "below" another device may now be described as "above" the other device. Therefore, the exemplary term "below" encompasses both above and below. A device may be rotated 90° or at other angles, and spatially relative terms should be interpreted accordingly.

[0030] Although the terms first, second, etc. are used in some instances herein to represent various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, the first interface and the second interface, etc. are represented. Furthermore, as used in this article, the singular forms "one," "an," and "the" are intended to also include the plural forms, unless there is a contrary indication in the context. It should be further understood that the terms "comprise," "include," and "include" indicate the presence of features, steps, operations, elements, components, items, types, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, types, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Therefore, "A, B, or C" or "A, B, and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B, and C." Exceptions to this definition only occur when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0031] Unless otherwise defined herein, all terms, including technical and scientific terms, used herein have the same meanings as those generally understood by those skilled in the art to which this specification belongs. Terms defined in commonly used dictionaries are to be interpreted as having meanings consistent with the relevant technical literature and current teachings and, unless otherwise defined, are not to be overly construed as idealized or highly formalized.

[0032] The structures of the scored guidewire, scored balloon assembly and interventional device of the present invention are further described below in conjunction with the accompanying drawings and specific embodiments. It can be understood that the various specific embodiments are not intended to limit the scope of protection of the present invention.

[0033] It should be noted that the proximal end and the distal end of the present invention are relative to the operator, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end.

[0034] The present invention provides a scored guide wire. Figure 1This is a schematic diagram of the distal end of a scored guidewire according to a first embodiment of the present invention. Specifically, the scored guidewire 1 includes a guidewire shaft 11 and a cutting unit 12 disposed around the distal end of the guidewire shaft 11. For example, the guidewire shaft 11 may be a 0.014-inch guidewire, and the distal end of the guidewire shaft 11 may be a reduced diameter section or a soft section to provide greater flexibility. For example, the outer diameter of the reduced diameter section may be configured to gradually decrease from the proximal end to the distal end.

[0035] The cutting unit 12 has an expanded state and a compressed state. The distal end of the cutting unit 12 is fixed to the distal end of the guidewire shaft 11, and the proximal end of the cutting unit 12 is an expandable annular structure. The annular structure here refers to the entire structure being arranged around the guidewire shaft 11 and not being directly connected to the outer periphery of the guidewire shaft 11. Therefore, there is an open space between the annular structure and the guidewire, and other annular components of appropriate size can pass through the open space to enter the interior of the cutting unit 12. Therefore, when the scoring guidewire 1 is combined with other instruments such as a balloon catheter, at least part of the distal end of the balloon catheter (such as the balloon body) can enter the interior of the cutting unit 12 through the annular structure. When the balloon body enters the interior of the cutting unit 12 and is pressurized and thus in an expanded state, the cutting unit 12 is also in an expanded state. Here, the annular structure refers to a ring-shaped projection on a plane perpendicular to the axis of the scored guidewire, which is not limited to a regular circular ring, for example, it can be an elliptical ring, a ring-like shape composed of polygons, etc.; the shape of the projection on a plane parallel to the axis of the scored guidewire is also not limited, for example, it can be a straight line, a curve, a wavy line or a grid.

[0036] Figure 2 This is a schematic structural diagram of the cutting unit of the scored guidewire of the first embodiment of the present invention. The cutting unit 12 includes a plurality of scored wires 121. The distal ends 1211 of the plurality of scored wires 121 are fixedly connected to the guidewire shaft 11. The distal ends 1211 of the plurality of scored wires 121 can be fixedly connected to the guidewire shaft 11 by laser welding or glue bonding, and the distal ends 1211 of the plurality of scored wires 121 can be a closed structure. Here, the closed structure refers to a non-expandable fixed connection structure, and has nothing to do with whether blood or fluid is allowed to pass through. When the cutting unit 12 is in an expanded state, the annular structure at its proximal end expands, and may drive the middle part of the cutting unit 12 (the part between the proximal end and the distal end) to expand together, but at this time the distal end of the cutting unit 12 still remains fixed to the guidewire shaft 11.

[0037] See also Figure 1 In the first embodiment, the scored guidewire 1 further includes a guide block 13 and a stopper 14 disposed on the guidewire shaft 11. The guide block may be a hollow structure so that it can reciprocate relative to the guidewire shaft 11. Figure 3This is a schematic structural diagram of the guide block for the scored guidewire according to the first embodiment of the present invention. The guide block 13 comprises a circular ring segment 131, a reducing segment 132, and an abutting segment 133, connected sequentially from the distal end to the proximal end. The diameter of the reducing segment 132 gradually increases from the distal end to the proximal end, forming a frustum-shaped structure. The outer diameter of the circular ring segment 131 is the same as the outer diameter of the distal end (i.e., the outer diameter of the smaller end) of the reducing segment 132. The outer diameter of the abutting segment 133 is less than or equal to the outer diameter of the stopper 14. The guide block 13 is used to slightly expand the annular structure 122 of the cutting unit during balloon delivery to increase the open space between the annular structure 122 and the guidewire shaft 11. The frustum-shaped structure of the reducing segment 132 enables the guide block 13 to guide the balloon more smoothly into the cutting unit. The limiter 14 is fixed to the guidewire shaft 11 and is located on the proximal side of the cutting unit 12 (i.e., in the axial direction of the guidewire shaft 11, the limiter 14 is closer to the proximal end of the guidewire shaft 11 than the cutting unit 12). The limiter 14 can be annular and can be connected and fixed to the guidewire by laser welding or glue. An annular structure 122 is provided at the proximal end of the cutting unit 12. The annular structure 122 is connected to the proximal ends of the multiple scoring wires 121. When the cutting unit 12 is in a compressed state, the annular structure 122 is sleeved on (i.e., overlaps / abuts on) at least a portion of the outer circumference of the guide block 13. When in conjunction with the balloon catheter, the guide block 13 can move back and forth between the limiter 14 and the distal end of the cutting unit 12, and when moving, the guide block 13 enters the cutting unit through the annular structure. Thus, when the notched guidewire 1 is used in conjunction with a balloon catheter, as the guide block 13 moves distally along the guidewire shaft 11, the reducing section 132 of the guide block 13 gradually passes through the annular structure 122 and the plurality of notched wires 121, causing the annular structure 122 to drive the plurality of notched wires 121 to be slightly expanded (but not yet to reach an expanded state), so that the balloon body can pass through the annular structure 122 under the guidance of the guide block 13 and enter the cutting unit 12.

[0038] In some embodiments, the plurality of scoring wires 121 can be obtained by a laser cutting integrated molding process, that is, a cutting unit including a plurality of scoring wires is obtained by laser cutting an integrated molding process from a tube or sheet, or a cutting unit can be formed by weaving a plurality of independent scoring wires, and the cross section of the scoring wire 121 is triangular, rectangular, trapezoidal or other polygonal. The plurality of scoring wires 121 can be in a spiral structure, a parallel arrangement structure or a grid structure, wherein the arrangement of the plurality of scoring wires 121 can be the same or different. Preferably, the plurality of scoring wires 121 are arranged in a spiral structure around the guide wire shaft 11, see Figure 1, so that the cutting unit is easier to switch between the compressed state and the expanded state. When changing from the compressed state to the expanded state, the multiple scoring wires 121 untwist and form a similar parallel arrangement structure. For example, as in the first embodiment, multiple scoring wires 121 with triangular cross-sections are spirally arranged to form a cutting unit with expanded and compressed states. When in the expanded state, the cutting unit untwists as a whole, causing the scoring wires 121 themselves to twist. There is always a part of the sharp corners of the scoring wires 121 in the normal direction of the cutting unit. The triangular cross-section allows the cutting stress of the cutting unit to be concentrated at the sharp corners of the triangle, allowing the cutting unit to more easily penetrate harder thrombus tissue or calcified lesions on the blood vessel wall, achieving efficient cutting, helping to quickly remove the lesion tissue and improve the treatment effect. It should be noted that the cutting unit can be formed into a spiral structure by three scoring wires 121, but the number of scoring wires 121 in application is not limited to three. It can be one spiral or multiple spirals, or it can be a grid structure formed by multiple spirals in opposite directions. At the same time, the scoring wire 121 can be formed by winding three wires, and the cross-section of the scoring wire 121 can also be a trapezoid, a rectangle or other polygon. The material of the scoring wire is preferably nickel-titanium alloy, that is, an alloy composed of nickel and titanium elements, or it can be a composite material composed of other elements added to nickel-titanium, such as a nickel-titanium composite material added with platinum tungsten, platinum iridium, tungsten or other materials, and the other added materials are preferably developing materials. Nickel-titanium alloy or nickel-titanium composite material has excellent shape memory properties, and the cutting unit can be heat-set to a predetermined shape and size. In some other embodiments, the material of the scoring wire can also be other metals or alloys, which are made into a predetermined shape and size by thermoforming.

[0039] The annular structure 122 at the proximal end of the cutting unit 12 can be repeatedly expanded, i.e., can be switched between an expanded state and a compressed state multiple times. In some embodiments, the annular structure 122 can be wavy, specifically comprising multiple metal rods with waveforms (e.g., sinusoidal waveforms) connected end to end. In practice, the annular structure 122 can be formed by laser cutting a metal ring to form the multiple waveforms connected end to end. When the cutting unit 12 is in the compressed state, the abutment section 133 of the guide block 13 abuts the stopper 14. At this time, the annular structure 122 in the compressed state is at least partially enclosed by the annular segment 131 of the guide block 13, i.e., overlaps the outer circumference of the annular segment 131. Therefore, the position of the stopper 14 is configured so that when the cutting unit 12 is in the compressed state and the abutment section 133 of the guide block 13 abuts the stopper 14, the annular structure 122 of the cutting unit 12 does not disengage from the annular segment 131 of the guide block 13. Thus, when the notched guidewire 1 is stored, transported and delivered during surgery, since the cutting unit 12 is in a compressed state, the annular structure 122 arranged on the distal end of the guide block 13 limits the movement of the guide block 13 in the distal direction. At the same time, the guide block 13 is also restricted from moving in the proximal direction by the limiting member 14, that is, the guide block 13 is limited between the annular structure 122 and the limiting member 14 and can remain relatively stationary.

[0040] In an embodiment, to facilitate the operator's clear observation of the position of the cutting unit within the blood vessel, the guide block 13 and / or the stopper 14 can be made of a material that is developable under X-rays. For example, the guide block 13 can be made of a metal, such as a platinum alloy (e.g., platinum-iridium / platinum-nickel / platinum-tungsten), an alloy (e.g., tungsten or tantalum), or gold, which exhibits relatively good development. However, the present invention is not limited to the metal materials listed here. In other alternative embodiments, metal materials other than those listed here may also be used. The guide block can be made of a nickel-titanium composite material, such as a wire containing a developing metal such as platinum or tantalum within nickel-titanium (e.g., a platinum-core nickel-titanium composite wire). Similarly, the stopper 14 can be made of a nickel-titanium alloy, a nickel-titanium composite material, a platinum-tungsten alloy, or a platinum-iridium alloy. In another alternative embodiment, the guide block 13 and the stopper 14 can also be made of a polymer tubing doped with a developing agent, such as a polyamide or nylon tubing doped with a developing agent. The developing agent can be a barium salt, a bismuth salt, a tungsten salt, metallic tungsten, metallic bismuth, metallic barium, or the like.

[0041] Figure 4This is a schematic structural diagram of the distal end of the scored guidewire 1b of the second embodiment of the present invention. In the second embodiment, the guidewire shaft 11b can be a 0.014-inch guidewire, and the material of the distal portion of the guidewire shaft 11b can be a nickel-titanium alloy, or a nickel-titanium composite material composed of nickel-titanium with other elements added, such as a nickel-titanium composite material with platinum-tungsten, platinum-iridium, tungsten, or other materials added. Unlike the first embodiment, a portion of the distal end of the guidewire shaft 11b is spirally bent around the guidewire shaft to form a spiral coil structure. This spiral coil structure is the cutting unit 12b of the scored guidewire 1b. The changes in the radius and spacing of the multiple spirals in the spiral coil structure cause the cutting unit to be in an expanded or compressed state. The spiral coil structure can be formed by heat-setting and pre-shaping the wire material. In this case, the cutting unit 12b and the guidewire shaft 11b are integrated, that is, the spiral coil structure and the guidewire shaft 11b are made of the same wire material. In the second embodiment, one end of the wire material forming the cutting unit 12b is a non-fixed end, and the non-fixed end is located at the proximal end of the cutting unit 12b. In this case, one or more spirals at the proximal end (i.e., the non-fixed end) of the helical coil structure constitute the annular structure 122b of the cutting unit 12b. When the scored guidewire 1b of the second embodiment is used with a balloon catheter, the balloon of the balloon catheter can enter the interior of the cutting unit 12b through the annular structure 122b. When the balloon is inflated and thus in an expanded state, the spiral radius of the helical wire structure increases, and the cutting unit 12b is also in an expanded state.

[0042] The cutting unit of the notched guidewire is not limited to the spiral coil structure in the second embodiment, and can be other variant expandable structures, such as other structures including a spiral coil. Figure 5 This is a structural schematic diagram of the distal end of the notched guidewire 1c of the third embodiment of the present invention. Unlike the second embodiment, the distal end of the guidewire shaft 11c is an unfixed end, that is, the unfixed end of the wire is located at the distal end of the cutting unit 12c, and one or more spirals at the nearest end of the cutting unit 12c constitute the annular structure 122c of the cutting unit 12c. The other structures and material settings of the notched guidewire 1c in the third embodiment can refer to the second embodiment. Similarly, when the notched guidewire 1c of the third embodiment is combined with a balloon catheter, the balloon body of the balloon catheter can enter the interior of the cutting unit 12c through the annular structure 122c. When the balloon body is inflated and is in an expanded state, the spiral radius of the spiral coil structure becomes larger, and the cutting unit 12c is also in an expanded state.

[0043] In the second and third embodiments, the radius and spacing of the spirals in the spiral coil structure can be designed and adjusted according to the size and length of the plaque at the lesion location. Preferably, the cross-section of the wire material in the spiral coil structure is a triangle, trapezoid or other angular polygon.

[0044] The scoring guidewire of the present invention is suitable for treating lesions of tortuous intracranial blood vessels and other blood vessels, such as peripheral blood vessels and cardiovascular diseases. Since the scoring guidewire is designed with a cutting unit having a ring structure, when the scoring guidewire reaches the lesion location, it can be directly expanded using a conventional balloon catheter. The expansion of the balloon body is used to expand the cutting unit on the scoring guidewire, thereby forcing the scoring wire of the cutting unit to squeeze and destroy vascular plaques, effectively treating more serious vascular calcification lesions such as CTO lesions. The cross-section of the scoring guidewire of the present invention is significantly smaller than that of the cutting balloon, and has excellent flexibility and passability. It can pass through tortuous or severely narrowed blood vessels, thereby eliminating the need for additional special balloons such as CTO balloons for pre-expansion, reducing surgical operation steps, reducing surgical damage to blood vessels, and reducing surgical complications.

[0045] The present invention also provides a scored balloon assembly, comprising any of the above-described scored guidewires and a balloon catheter 2. The balloon catheter 2 is configured to be sheathed over the guidewire shaft 11 of the scored guidewire 1 and movable along the sheath, and comprises an inner lumen, an outer tube, and a balloon body. The distal end of the inner lumen passes through the balloon body, and the distal end of the balloon body is connected to the distal end of the inner lumen. The outer tube is connected to the proximal end of the balloon body and sheathed over the inner lumen. The space between the inner lumen and the outer tube, and between the inner lumen and the balloon body, is used to inflate with air or liquid to expand the balloon by pressurization and to deflate it by depressurization.

[0046] Figures 6 to 8Schematic diagrams of the structure of a scored balloon assembly in various states according to an embodiment of the present invention are provided. The scored guidewire in this embodiment is the same as that of the first embodiment, namely, the scored guidewire further includes a guide block 13 and a stopper 14 sleeved on a guidewire shaft 11. The distal end 21 of the balloon catheter 2 can pass over the outer edge of the stopper 14 and abut against the abutment section 133 of the guide block 13, thereby enabling the distal end of the balloon catheter 2 (e.g., part or the entire balloon body) to enter the cutting unit and cause the cutting unit to enter an expanded state, ultimately achieving treatment of vascular calcification. For example, the stopper 14 is cylindrical, and the inner diameter of the distal end 21 of the balloon body should be larger than the outer diameter of the cylindrical stopper 14. At the same time, the inner diameter of the distal end 21 of the balloon body should be smaller than the outer diameter of the proximal end of the reducing section 132 of the guide block 13 (i.e., the maximum outer diameter of the guide block 13). In this case, distal movement of the balloon catheter 2 can drive distal movement of the guide block 13. It should be noted that the distal tube 21 herein can be integral with the distal end of the inner lumen tube. In this case, the distal tube 21 is the inner lumen tube at the distal end of the balloon catheter 2, or in other words, the distalmost end of the inner lumen tube. In other embodiments, the distal tube 21 can also be a tube segment connected to the distal end of the inner lumen tube, constituting the distalmost end of the balloon catheter 2. Therefore, the inner diameter of the inner lumen tube at the distal end of the balloon catheter 2 is larger than the maximum outer diameter of the stopper 14 and smaller than the maximum outer diameter of the guide block 13. When the balloon catheter 2 moves distally relative to the scored guidewire, the distal end of the balloon catheter 2 passes over the stopper 14 and abuts against the proximal end of the guide block 13. Guided by the guide block 13, the distal end of the balloon catheter 2 enters the cutting unit 12 and continues to push the guide block 13 distally until the guide block 13 reaches the distal end of the cutting unit 12, at which point the balloon body is located within the cutting unit 12. When the balloon enters the interior of the cutting unit 12 through the annular structure and the balloon is pressurized, the cutting unit 12 is then expanded. When the balloon is depressurized, the cutting unit 12 returns to or substantially returns to the compressed state. In addition, the distal end of the balloon catheter 2 and the proximal end of the guide block 13 are preferably tightly matched, so that when the balloon catheter 2 is withdrawn toward the proximal end, the guide block 13 can be driven to withdraw from the cutting unit to reduce the outer diameter of the cutting unit during withdrawal. When using the scored balloon assembly, the scored guide wire 1 is pushed to the location of the diseased plaque 91 of the blood vessel 9 by direct pushing or with the help of a matching guide catheter, as shown in FIG. Figure 6 As shown, at this time, the scoring guidewire 1 should pass through the diseased plaque 91 (the guide catheter should be removed if necessary); then the balloon catheter 2 is pushed along the guidewire shaft 11. When the balloon body of the balloon catheter 2 is pushed to the limiter 14 of the scoring guidewire, the inner diameter of the distal tube 21 of the balloon body crosses the limiter 14 and abuts against the guide block 13. The distal tube 21 of the balloon body is tightly matched with the abutment section 133 of the guide block 13, as shown in FIG. Figure 7As shown; continue to push the balloon body, at this time the guide block 13 and the balloon body are pushed forward at the same time. Due to the tapered structure of the reducing section 132 of the guide block 13, when the guide block 13 passes through the cutting unit 12, the annular structure 122 at the proximal end of the cutting unit 12 will be slightly opened, and the balloon body follows the guide block 13 into the interior of the cutting unit 12, and continues to push the balloon body until the annular section 131 of the guide block 13 abuts against the distal end of the cutting unit 12, and the balloon body reaches the predetermined position, as shown. Figure 8 As shown. At this time, the balloon is directly pressurized to expand, and the scoring wire on the cutting unit 12 is stretched to an expanded state by the expansion of the balloon, thereby forcing the scoring wire to squeeze and destroy the vascular plaque. When the plaque cutting operation is completed, the balloon is depressurized and the balloon catheter 2 is withdrawn. Since the distal tube 21 of the balloon catheter 2 is tightly fitted with the abutment section 133 of the guide block 13, the guide block 13 will follow the balloon to withdraw until it contacts the limiter 14 and is blocked by it. At the same time, the cutting unit 12 returns to the contracted state due to the shape memory effect of the nickel-titanium alloy (or nickel-titanium composite material) (see Figure 1 ); Continue to withdraw the balloon catheter 2 until the balloon catheter 2 is completely withdrawn; finally withdraw the notched guidewire. When it comes to intracranial blood vessels or other tortuous blood vessels, this withdrawal step can be assisted by a microcatheter or a matching guide catheter.

[0047] The scored guidewire of the present invention can pass through the tortuous intracranial blood vessels to reach the location of the intracranial calcified lesion, and then a conventional balloon catheter is used to follow the scored guidewire through the lesion to reach the location of the scored wire. Since the distal end of the scored guidewire is provided with a cutting unit, the balloon body of the balloon catheter can cut the calcified lesion during the angioplasty process through the scored wire of the cutting unit when the balloon body is expanded to enhance the expansion effect. The scored balloon assembly of the present invention can realize the treatment of moderately calcified intracranial lesions by using a conventional balloon.

[0048] When the notched guidewire 1 is not equipped with a guide catheter 4, the notched guidewire 1 is pre-loaded in the protective catheter 3. During surgery, the cutting unit of the notched guidewire is delivered to the location of the vascular lesion, which is the same as the method of using a common guidewire. For intracranial blood vessels or other tortuous blood vessels, it can be used in conjunction with other instruments, such as a 0.021-inch microcatheter.

[0049] The present invention also provides an interventional device, which includes a guide catheter and the above-mentioned scoring guidewire that can move within the guide catheter. In another embodiment, the interventional device includes a guide catheter, the above-mentioned scoring guidewire 1 and a balloon catheter 2, wherein the scoring guidewire 1 and the balloon catheter 2 are movably arranged within the guide catheter, and the balloon catheter 2 is sleeved on the guidewire shaft 11 of the scoring guidewire 1 and can move along the guidewire shaft 11. The scoring guidewire 1 can be pre-installed in the guide catheter 4 if necessary, see Figure 9After the notched guidewire 1 delivers the cutting unit of the notched guidewire 1 to the location of the vascular lesion through the guide catheter 4, the guide catheter 4 is withdrawn and the balloon catheter 2 is delivered along the guidewire shaft 11 to the proximal end of the cutting unit 12 to realize the combined use of the cutting unit and the balloon body.

[0050] In some embodiments, the guide catheter 4 includes a delivery section 41 at one end and a retrieval section 42 at the other end. Figure 10 This is a schematic structural diagram of a guide catheter for an interventional device according to an embodiment of the present invention. The hardness of the delivery section 41 is less than that of the retrieval section 42, that is, the delivery section 41 is softer. The two ends of different hardness make the entire scored guidewire have better passability and flexibility when being pushed and are more convenient for the retrieval of the scored guidewire 1. Preferably, the free end of the delivery section 41 is a soft section 41A to prevent the small and tortuous blood vessels at the distal end from being scratched during delivery, and the free end of the retrieval section 42 is a flared structure 42A to facilitate the pushing of the guidewire shaft 11 and the retrieval of the scored guidewire 1. Specifically, when it is necessary to deliver the scored guidewire 1 from outside the body to the lesion site for treatment, the delivery section 41, as the distal end of the guide catheter 4, first enters the human body and delivers the cutting unit 12 at the distal end of the scored guidewire 1 to the lesion blood vessel segment. The softer delivery section 41 ensures the safety of the device delivery process, and at this time the retrieval section 42 is located at the proximal end (closer to the operator). When the scored guidewire 1 needs to be withdrawn from the lesion site to the body, the retrieval segment 42 serves as the distal end of the guide catheter 4 and enters the body. At this time, the relatively higher hardness of the retrieval segment 42 provides better support for the distal end of the guide catheter 4, making the retrieval of the entire scored guidewire 1, especially the cutting unit 12, easier. In particular, the flared structure 42A facilitates the retrieval of the annular structure at the proximal end of the cutting unit 12 into the guide catheter 4. The hardness difference between the retrieval segment 42 and the delivery segment 41 can be achieved by using different materials or different material components. For example, the retrieval segment 42 and the delivery segment 41 can be made of polyether block amide (PEBAX) with different Shore hardnesses. For example, the retrieval segment 42 can be made of PEBAX 6333 (Shore D hardness 64) and the delivery segment 41 can be made of PEBAX 3533 (Shore D hardness 33). The hardness difference between the recovery section 42 and the conveying section 41 can also be achieved by adopting different structures and / or size designs. For example, the recovery section 42 is a double-layer tube with a metal braided layer in the middle, and the conveying section 41 is a single-layer tube.

[0051] The above content is a further detailed description of the present invention in conjunction with specific preferred embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, it is obvious that the present application is not limited to the details of the above-mentioned exemplary embodiments, and the present application can be implemented in other specific forms without departing from the spirit or basic characteristics of the present application. Therefore, no matter from which point of view, the embodiments should be regarded as exemplary and non-restrictive, and the scope of the present application is limited by the attached claims rather than the above description, and it is intended that all changes that fall within the meaning and scope of the equivalent elements of the claims are included in the present application. Any figure mark in the claims should not be regarded as limiting the claims involved.

Claims

1. A scored guidewire, characterized in that: It comprises a guide wire shaft and a cutting unit arranged around the distal end of the guide wire shaft; The cutting unit has an expanded state and a compressed state, the distal end of the cutting unit is fixed to the guide wire shaft, and the proximal end of the cutting unit is an expandable ring structure; The scoring guidewire is configured such that, when the scoring guidewire is engaged with the balloon catheter, at least a portion of the distal end of the balloon catheter passes through the annular structure and enters the interior of the cutting unit.

2. The scored guidewire according to claim 1, characterized in that The notched guidewire further includes a guide block and a limiter provided on the guidewire shaft; The limiting member is fixed to the guide wire shaft and is located on the proximal side of the cutting unit; The guide block is configured to be reciprocally movable between the limiting member and the distal end of the cutting unit, and when moving, the guide block passes through the annular structure and enters the cutting unit.

3. The scored guidewire according to claim 2, characterized in that The maximum outer diameter of the limiting member is greater than the minimum inner diameter of the guide block.

4. The scored guidewire according to claim 2, wherein The cutting unit includes a plurality of scoring wires, the distal ends of the plurality of scoring wires are fixedly connected to the guide wire shaft, and the proximal ends of the plurality of scoring wires are provided with the annular structure. When the cutting unit is in the compressed state, the annular structure is sleeved on at least part of the outer circumference of the guide block.

5. The scored guidewire according to claim 4, wherein Each of the scoring wires comprises a plurality of wires; and / or The cross section of the scored wire is triangular, rectangular, trapezoidal or other polygonal; and / or The plurality of scored wires are in a spiral structure, a parallel arrangement structure or a grid structure; and / or The plurality of scoring wires are obtained by a laser cutting integral molding process or are formed into the cutting unit by weaving; and / or The material of the scoring wire is nickel-titanium alloy or nickel-titanium composite material, and the plurality of scoring wires are formed into the compressed state through a heat setting process.

6. The scored guidewire according to claim 1, characterized in that The annular structure is composed of a plurality of corrugated metal rods connected end to end.

7. The scored guidewire according to claim 2, wherein: The guide block comprises a circular ring section, a diameter-changing section and an abutting section in sequence from the distal end to the proximal end, and the diameter of the diameter-changing section gradually increases in the direction from the distal end to the proximal end.

8. The scored guidewire according to claim 2, characterized in that The guide block is made of a developing material; and / or The limiting component is made of developing material.

9. The scored guidewire according to any one of claims 1 to 8, characterized in that: The cutting unit includes a spiral coil structure formed by spirally bending around the guide wire shaft, and the spiral coil structure and the guide wire shaft are made of the same wire material.

10. The scored guidewire according to claim 9, characterized in that The material of the spiral coil structure includes nickel-titanium alloy or nickel-titanium composite material, and the spiral coil structure is formed by heat setting pre-shaping.

11. A scored balloon assembly, characterized in that: The invention comprises the scored guidewire according to any one of claims 1 to 10 and a balloon catheter, wherein the balloon catheter is configured to be sleeved on the guidewire shaft of the scored guidewire and movable along the guidewire shaft; The balloon catheter comprises an inner lumen tube, an outer tube and a balloon body, wherein the distal end of the inner lumen tube passes through the balloon body, the distal end of the balloon body is connected to the distal end of the inner lumen tube, and the outer tube is connected to the proximal end of the balloon body and is sheathed outside the inner lumen tube; When the balloon enters the interior of the cutting unit through the annular structure and is pressurized, the cutting unit of the scoring guidewire is in an expanded state; when the balloon is depressurized, the cutting unit is in a compressed state.

12. The scored balloon assembly according to claim 11, wherein: The notched guidewire further includes a guide block and a limiter sleeved on the guidewire shaft; The limiting member is fixed to the guide wire shaft and is located on the proximal side of the cutting unit; The guide block is configured to be reciprocally movable between the limiting member and the distal end of the cutting unit, and when moving, the guide block passes through the annular structure and enters the cutting unit; When the balloon catheter moves distally relative to the notched guidewire, the distal end of the balloon catheter passes over the stopper and abuts against the proximal end of the guide block.

13. The scored balloon assembly according to claim 12, wherein: The inner diameter of the inner cavity tube at the distal end of the balloon catheter is larger than the maximum outer diameter of the limiter and smaller than the maximum outer diameter of the guide block. The distal end of the balloon catheter is tightly matched with the proximal end of the guide block.

14. An interventional device, characterized in that: The interventional device includes a guide catheter, a balloon catheter and the scored guidewire according to any one of claims 1 to 10, wherein the scored guidewire and the balloon catheter are movably arranged in the guide catheter, and the balloon catheter is sleeved on the guidewire shaft of the scored guidewire and is movable along the guidewire shaft.

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