Scored guidewire, scored balloon assembly, and interventional device

Abstract

The application provides a scoring guide wire, a scoring balloon assembly and an interventional device. The scoring guide wire comprises a guide wire shaft and a cutting unit. 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 is an expandable ring structure. When the scoring guide wire is combined with a balloon catheter, the distal end of at least part of the balloon catheter enters the interior of the cutting unit through the ring structure. The scoring guide wire of the application is provided with a cutting unit, which is used in combination with a balloon catheter to achieve the function of cutting the balloon. Since the scoring guide wire is separated from the balloon body, the passability and flexibility of the product are better than those of the cutting balloon and other products. When applied to the treatment of moderate calcification lesions in intracranial blood vessels, it is not easy to cause vascular injury and reduce surgical complications. For severe calcification lesions of cardiovascular and peripheral blood vessels, the expansion of plaques can be achieved without the need for additional use of a CTO balloon for pre-expansion, thereby reducing the cost and difficulty of the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a scoring guide wire, a scoring balloon assembly and an interventional device. BACKGROUND

[0002] The rate of arterial calcification generally increases with the age of a person, and the incidence in the population of 60-69 years old is about 80%. The higher the degree of arterial stenosis, the greater the probability of calcification. Atherosclerosis can cause an increase in vascular stiffness and a decrease in compliance, posing a significant threat to human health. Percutaneous interventional surgery can quickly open the occluded blood vessels, improve blood supply, and achieve reperfusion of ischemic myocardium, cerebral vessels, peripheral vessels, etc., and can effectively treat coronary heart disease, stroke, and peripheral vascular diseases. As a commonly used vascular reconstruction method, vascular interventional therapy has the advantages of high patency rate and ideal effect.

[0003] At present, a conventional working balloon can handle superficial calcified lesions, but the success rate of expansion for moderate calcified lesions is low, and the incidence of complications is high. The scoring balloon (or cutting balloon) on the market is based on a conventional working balloon and is more suitable for treating moderate calcified lesions.

[0004] For severe calcified lesions, such as Chronic Total Occlusion of Coronary Artery (CTO) lesions, even if the guide wire can pass through the lesion site, the existing scoring balloon (or cutting balloon) with a large cross section cannot follow the guide wire through the lesion site, and generally requires the use of other special balloons (such as CTO balloons) for pre-expansion before using the scoring balloon, increasing the cost and difficulty of the surgery. At the same time, due to the large cross section of the scoring balloon, for intracranial blood vessels (including vertebral arteries, etc.), the path of the blood vessels is relatively tortuous, and the pushing resistance of the scoring balloon is large, and there is no scoring balloon suitable for intracranial blood vessels on the market. The existing scoring balloon has a large cross section, which further results in poor passability and flexibility compared with conventional balloons, and thus is more likely to cause vascular injury, resulting in surgical complications, and in severe cases, may endanger life.

[0005] It should be noted that the information disclosed in the above background section is only used to strengthen the understanding of the background of the present application, and thus can include information that does not constitute prior art known to those of ordinary skill in the art. SUMMARY

[0006] In view of the problems in the prior art, the purpose of the present application is to provide a scoring guide wire, a scoring balloon assembly and an interventional device, which has a simple and convenient preparation process, is easy to operate, is suitable for various blood vessels and multiple purposes, and is especially suitable for tortuous or narrow blood vessels, thereby avoiding the problems of insufficient passability and flexibility of the cutting balloon in the prior art.

[0007] The first aspect of the present application provides a scoring guide wire, comprising a guide wire shaft and a cutting unit arranged around the distal end of the guide wire shaft;

[0008] 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;

[0009] The scoring guide wire is configured such that, when the scoring guide wire is matched with a balloon catheter, at least part of the distal end of the balloon catheter enters the interior of the cutting unit through the ring structure.

[0010] According to the first aspect of the present application, the scoring guide wire further comprises a guide block and a limiting piece arranged on the guide wire shaft;

[0011] The limiting piece is fixed to the guide wire shaft and located proximally to the cutting unit;

[0012] The guide block is configured to reciprocally move between the limiting piece and the distal end of the cutting unit, and when moving, the guide block enters the cutting unit through the ring structure.

[0013] According to the first aspect of the present application, the maximum outer diameter of the limiting piece is greater than the minimum inner diameter of the guide block.

[0014] According to the first aspect of the present application, the cutting unit comprises 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 arranged in the ring structure, when the cutting unit is in the compressed state, the ring structure is sleeved on at least part of the outer peripheral surface of the guide block.

[0015] According to the first aspect of the present application, each of the scoring wires comprises a plurality of wire rods; and / or

[0016] The cross section of the scoring wire is triangular, rectangular, trapezoidal or other polygonal, and / or

[0017] The plurality of scoring wires are in a spiral structure, a parallel arrangement structure or a grid structure; and / or

[0018] The plurality of scoring wires are obtained by a laser cutting integral molding process or the cutting unit is formed by weaving; and / or

[0019] The material of the score wire is a nickel-titanium alloy or a nickel-titanium composite material, and the plurality of score wires are formed into the compressed state through a heat setting process.

[0020] According to a first aspect of the present application, the annular structure is formed by a plurality of wave-shaped metal rods connected end to end.

[0021] According to a first aspect of the present application, the guide block comprises, from distal end to proximal end, a circular ring segment, a variable diameter segment, and an abutting segment, the diameter of the variable diameter segment gradually increases in the direction from distal end to proximal end.

[0022] According to a first aspect of the present application, the guide block is made of a developing material; and / or

[0023] The limiting member is made of a developing material.

[0024] According to a first aspect of the present application, the cutting unit comprises a spiral coil structure formed by helically bending around the guide wire shaft, and the spiral coil structure and the guide wire shaft are integrally made of the same wire material.

[0025] According to a first aspect of the present application, the material of the spiral coil structure comprises a nickel-titanium alloy or a nickel-titanium composite material, and the spiral coil structure is formed through heat setting pre-molding.

[0026] A second aspect of the present application provides a score balloon assembly comprising the score guide wire of the first aspect of the present application and a balloon catheter configured to be sleeved on the guide wire shaft of the score guide wire and movable thereon.

[0027] The balloon catheter comprises an inner lumen tube, an outer tube, and a balloon body, wherein the distal end of the inner lumen tube penetrates 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 sleeved outside the inner lumen tube.

[0028] When the balloon body enters the inside of the cutting unit through the annular structure and is inflated, the cutting unit of the score guide wire is expanded, and when the balloon body is deflated, the cutting unit is compressed.

[0029] According to a second aspect of the present application, the score guide wire further comprises a guide block and a limiting member sleeved on the guide wire shaft.

[0030] The limiting member is fixed to the guide wire shaft and located proximally to the cutting unit.

[0031] The guide block is configured to reciprocally move between the limiting member and the distal end of the cutting unit, and when moving, the guide block enters the cutting unit through the annular structure.

[0032] When the balloon catheter moves distally relative to the score guide wire, the distal end of the balloon catheter passes the stopper and abuts against the proximal end of the guide block.

[0033] According to the second aspect of the present application, the inner diameter of the inner lumen tube of the distal end of the balloon catheter is greater than the maximum outer diameter of the stopper and less than the maximum outer diameter of the guide block, and the distal end of the balloon catheter is tightly fitted with the proximal end of the guide block.

[0034] The third aspect of the present application provides an interventional device, which comprises a guide catheter, a balloon catheter and the score guide wire of the first aspect of the present application, the score guide wire and the balloon catheter are movably arranged in the guide catheter, and the balloon catheter is sleeved on the score guide wire and movable along the same.

[0035] According to the third aspect of the present application, the guide catheter comprises a delivery section at one end and a recovery section at the other end, the hardness of the delivery section is less than that of the recovery section, and the free end of the recovery section is in a flared structure.

[0036] The score guide wire of the present application is provided with a cutting unit, which can realize the function of cutting the balloon when used in cooperation with the balloon catheter. Since the score guide wire of the present application does not include a balloon body itself, the passability and flexibility of the product are better than those of the score balloon or cutting balloon and the like, and the product is more easily passed through and used to treat moderate or above calcified lesions. When applied to treat intracranial blood vessels and the like small and tortuous blood vessels, the product is not easy to cause vascular injury and reduce surgical complications. For severe calcified lesions of cardiovascular and peripheral blood vessels, the product can realize the expansion of plaques without the need of additionally using a CTO balloon for pre-expansion, thereby reducing the surgical cost and difficulty. The preparation process of the score guide wire of the present application is simple and convenient, easy to operate, suitable for various blood vessels and multiple purposes, and avoids the problem of insufficient passability and flexibility of the cutting balloon in the prior art, thereby significantly improving the safety and ease of operation of treatment. BRIEF DESCRIPTION OF DRAWINGS

[0037] The accompanying drawings, which are incorporated herein and constitute part of the specification, illustrate embodiments consistent with the application and, together with the description, further serve to explain the principles of the application. Other features, objects, and advantages of the application will be apparent from the detailed description of non-limiting embodiments that follows, taken in conjunction with the accompanying drawings. It will of course be understood that the drawings described below are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort on the basis of these drawings. In addition, the drawings are only schematic illustrations of the present disclosure and are not necessarily drawn to scale. The same reference numerals in the drawings represent the same or similar parts, and thus repeated description thereof will be omitted. Some of the block diagrams shown in the drawings are functional entities, which do not necessarily have to correspond to physically or logically independent entities.

[0038] Figure 1 Structure diagram of a score guide wire for a first embodiment of the present application;

[0039] Figure 2 Structure diagram of a cutting unit of a score guide wire for a first embodiment of the present application;

[0040] Figure 3 Structure diagram of a guide block of a score guide wire for a first embodiment of the present application;

[0041] Figure 4 Structure diagram of a score guide wire for a second embodiment of the present application;

[0042] Figure 5 Structure diagram of a score guide wire for a third embodiment of the present application;

[0043] Figures 6 to 8 Structure diagram of each state of a score balloon assembly for an embodiment of the present application;

[0044] Figure 9 Structure diagram of a part of an interventional device for an embodiment of the present application; and

[0045] Figure 10 Structure diagram of a guide catheter of an interventional device for an embodiment of the present application. DETAILED DESCRIPTION

[0046] Example implementations will now be described more fully with reference to the accompanying drawings. Example implementations can be implemented in any

[0047] In the description of the specification, expressions of the term "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. mean that a specific feature, structure, material or characteristic represented with the embodiment or example is included in at least one embodiment or example of the specification. Also, the specific feature, structure, material or characteristic represented in the expression can be combined in any appropriate way in one or more embodiments or examples. In addition, the person skilled in the art can combine and combine the features of different embodiments or examples and the features of different embodiments or examples represented in the specification without contradiction.

[0048] Furthermore, the terms "first", "second", etc. are used herein only to distinguish one identification entity from another identification entity, and do not necessarily indicate or imply a relative importance or a specific order. Thus, a feature identified as a "first" feature can implicitly or explicitly include at least one of the feature. In the description of the specification, the meaning of "a plurality" is two or more, unless explicitly specifically defined otherwise.

[0049] Throughout the specification, when it is said that an element is "connected" to another element, this includes not only the case of "direct connection", but also the case of "indirect connection" in which other elements are interposed therebetween. In addition, when it is said that an element "includes" a certain constituent element, unless specifically stated to the contrary, other constituent elements are not excluded, but it means that other constituent elements can also be included.

[0050] Terms indicating relative spaces such as "lower", "upper", etc. can be used in order to more easily explain the relationship of one device with respect to another device illustrated in the drawings. Such terms mean not only the meaning indicated in the drawings, but also other meanings or operations of the device in use. For example, if the device in the drawing is turned upside down, a device that was explained as being "lower" than another device is explained as being "upper" than the other device. Thus, the exemplary term "lower" includes both upper and lower. The device can be rotated by 90° or other angles, and the terms indicating relative spaces are also interpreted accordingly.

[0051] Although the terms first, second, etc. can be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first interface and a second interface, etc. are described. Also, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises", "comprising", "includes" and / or "including", means the presence of stated features, steps, operations, elements, components, items, kinds and / or groups but does not preclude the presence or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups thereof. The terms "or" and "and / or" as used herein are to be interpreted as inclusive or meaning either 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". An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.

[0052] Unless otherwise defined, all terms used in disclosing the application, including technical and scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Methods and materials are described herein for use in the present application and in its practices.

[0053] The structure of the scoring guidewire, the scoring balloon assembly and the interventional device of the present application will be further described below in conjunction with the accompanying drawings and specific embodiments. It should be understood that each specific embodiment is not intended to limit the scope of protection of the present application.

[0054] It should be noted that the proximal end and the distal end of the present application 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.

[0055] The present application provides a scoring guidewire, Figure 1 The structure diagram of the distal end of the scoring guidewire of the first embodiment of the present application, specifically, the scoring guidewire 1 comprises a guidewire shaft 11 and a cutting unit 12 arranged around the distal end of the guidewire shaft 11. For example, the guidewire shaft 11 can be a 0.014 inch guidewire, and the distal end of the guidewire shaft 11 can be a variable diameter section or a soft section to make the distal end of the guidewire shaft 11 have better flexibility, for example, the outer diameter of the variable diameter section is gradually reduced from the proximal end to the distal end.

[0056] 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 ring structure. The ring structure here means that it is arranged around the guidewire shaft 11 as a whole and is not directly connected to the outer periphery of the guidewire shaft 11, so there is an open space between the ring structure and the guidewire, and other ring-shaped components of appropriate size can pass through the open space to enter the inside of the cutting unit 12. Therefore, when the scoring guidewire 1 is matched with other instruments such as a balloon catheter, at least part of the distal end of the balloon catheter (such as a balloon body) can pass through the ring structure to enter the inside of the cutting unit 12, and when the balloon body enters the inside of the cutting unit 12 and is pressurized to be in an expanded state, the cutting unit 12 is also in an expanded state. Here, the ring structure refers to a projection in the form of a ring in a plane perpendicular to the axis of the scoring guidewire, which is not limited to a regular circular ring, for example, it can be an elliptical ring, a polygonal ring, etc.; the shape of the projection in the plane parallel to the axis of the scoring guidewire is also not limited, for example, it can be a straight line, a curve, a wavy line or a grid shape, etc.

[0057] Figure 2For the structure diagram of the cutting unit of the score guide wire of the first embodiment of the present application, the cutting unit 12 comprises a plurality of score wires 121, the distal ends 1211 of the plurality of score wires 121 are fixedly connected with the guide wire shaft 11, the distal ends 1211 of the plurality of score wires 121 can be fixedly connected with the guide wire shaft 11 by means of laser welding or glue bonding, etc., and the distal ends 1211 of the plurality of score wires 121 can be a closed structure. Here, the closed structure refers to a fixed connection structure that cannot be expanded, and is irrelevant to whether blood or fluid is allowed to pass through. When the cutting unit 12 is in an expanded state, the annular structure of the proximal end is expanded, and the middle part of the cutting unit 12 (the part between the proximal end and the distal end) can be expanded together, but the distal end of the cutting unit 12 still remains fixed with the guide wire shaft 11 at this time.

[0058] Referring to Figure 1 In the first embodiment, the score guide wire 1 further comprises a guide block 13 and a limiting piece 14 arranged on the guide wire shaft 11. The guide block can be a hollow structure, so that it can reciprocate relative to the guide wire shaft 11. Figure 3As shown in FIG. 1, the scribing guide wire 1 comprises a guide block 13, a cutting unit 12 and a limiting member 14. The guide block 13 is connected to the distal end of the guide wire shaft 11. The guide block 13 comprises a circular segment 131, a variable diameter segment 132 and an abutting segment 133 connected in sequence from the distal end to the proximal end. The diameter of the variable diameter segment 132 gradually increases in the direction from the distal end to the proximal end, forming a frustum structure. The outer diameter of the circular segment 131 is the same as the outer diameter of the distal end of the variable diameter segment 132 (i.e. the outer diameter of the smaller end). The outer diameter of the abutting segment 133 is less than or equal to the outer diameter of the limiting member 14. The guide block 13 is used to slightly expand the annular structure 122 of the cutting unit 12 to increase the open space between the annular structure 122 and the guide wire shaft 11 when the balloon is delivered. The above-mentioned frustum structure of the variable diameter segment 132 makes the guide block 13 guide the balloon to enter the cutting unit more smoothly. The limiting member 14 is fixed to the guide wire shaft 11 and located proximally of the cutting unit 12 (i.e. in the axial direction of the guide wire shaft 11, the limiting member 14 is closer to the proximal end of the guide wire shaft 11 than the cutting unit 12). The limiting member 14 can be circular and can be connected and fixed to the guide wire by laser welding or glue. The proximal end of the cutting unit 12 is provided with an annular structure 122 connected to the proximal end of a plurality of scribing wires 121. When the cutting unit 12 is in a compressed state, the annular structure 122 is sleeved (i.e. overlapped / abutted) on at least part of the outer peripheral surface of the guide block 13. When cooperating with the balloon catheter, the guide block 13 can reciprocate between the limiting member 14 and the distal end of the cutting unit 12, and the guide block 13 enters the cutting unit through the annular structure during movement. Thus, when the scribing guide wire 1 is used in cooperation with the balloon catheter, as the guide block 13 moves distally along the guide wire shaft 11, the variable diameter segment 132 of the guide block 13 gradually passes through the annular structure 122 and the plurality of scribing wires 121, so that the annular structure 122 drives the plurality of scribing wires 121 to be slightly expanded (but not yet in an expanded state), so that the balloon can enter the cutting unit 12 under the guidance of the guide block 13 through the annular structure 122.

[0059] In some embodiments, the plurality of scribing wires 121 can be obtained by a laser cutting integrated molding process, i.e. a cutting unit comprising a plurality of scribing wires is obtained by laser cutting an integrated molding of a pipe or sheet. Alternatively, the cutting unit can be formed by weaving a plurality of independent scribing wires. The cross section of the scribing wire 121 can be triangular, rectangular, trapezoidal or other polygonal shape. The plurality of scribing wires 121 can be in a spiral structure, parallel arrangement structure or grid structure, wherein the arrangement of the plurality of scribing wires 121 can be the same or different. Preferably, the plurality of scribing wires 121 is arranged in a spiral structure around the guide wire shaft 11, as shown in FIG. 2. Figure 1Therefore, the cutting unit is easier to convert between the compressed state and the expanded state, and when converted from the compressed state to the expanded state, the plurality of score wires 121 are untwisted to form a structure similar to a parallel arrangement. For example, as in the first embodiment, the plurality of triangular cross-section score wires 121 are arranged in a spiral to form a cutting unit having an expanded state and a compressed state. When in the expanded state, the cutting unit as a whole is untwisted, causing the score wires 121 to twist, and the sharp corners of some of the score wires 121 are always in the normal direction of the cutting unit. The triangular cross-section allows the cutting stress of the cutting unit to be concentrated on the sharp corners of the triangular cross-section, allowing the cutting unit to more easily penetrate into the harder thrombus tissue or calcified lesion site of the blood vessel wall, achieving efficient cutting and helping to quickly remove the lesion tissue and improve treatment effect. It should be noted that the cutting unit can be formed by three score wires 121 in a spiral structure, but the number of score wires 121 is not limited to three, and can be one spiral or multiple spirals, or a grid structure formed by multiple spirals in opposite directions. At the same time, the score wire 121 can be wound by three wires, and the cross-section of the score wire 121 can be trapezoidal, rectangular, or other polygons. The material of the score wire is preferably nickel-titanium alloy, i.e., an alloy composed of nickel and titanium elements, or a composite material composed of nickel-titanium and other elements, such as nickel-titanium composite material with platinum-tungsten, platinum-iridium, tungsten, or other materials. The added other materials are preferably imaging materials. Nickel-titanium alloy or nickel-titanium composite material has excellent shape memory performance and can heat set the cutting unit to a predetermined shape and size. In other embodiments, the material of the score wire can also be other metals or alloys, which are heat shaped to a predetermined shape and size.

[0060] The ring structure 122 at the proximal end of the cutting unit 12 can be repeatedly expanded, i.e., can be converted between the expanded state and the compressed state multiple times. In some embodiments, the ring structure 122 can be wavy, specifically, can be composed of a plurality of wave shapes (e.g., sinusoidal wave shapes) connected end to end. In practice, the ring structure 122 can be formed by laser cutting a metal ring into a plurality of wave shapes connected end to end. When the cutting unit 12 is in the compressed state, the abutting section 133 of the guide block 13 abuts against the limiting member 14, at this time, the ring structure 122 in the compressed state is at least partially sleeved on the annular section 131 of the guide block 13, i.e., is lapped on the outer periphery of the annular section 131. Therefore, the position of the limiting member 14 is set such that when the cutting unit 12 is in the compressed state and the abutting section 133 of the guide block 13 abuts against the limiting member 14, the ring structure 122 of the cutting unit 12 does not disengage from the annular section 131 of the guide block 13. Thus, when the scoring guide wire 1 is in the process of storage, transportation and intraoperative delivery, since the cutting unit 12 is in the compressed state, the ring structure 122 sleeved on the distal end of the guide block 13 limits the movement of the guide block 13 in the distal direction, and at the same time, the guide block 13 is also limited by the limiting member 14 from moving in the proximal direction, i.e., the guide block 13 is limited between the ring structure 122 and the limiting member 14 and can remain relatively stationary.

[0061] In embodiments, in order to facilitate the operator to more clearly observe the position of the cutting unit in the blood vessel, the guide block 13 and / or the limiting member 14 can be made of a developing material that has developing effect under X-ray, for example, the guide block 13 can adopt a metal, such as platinum alloy, tungsten or tantalum alloy or gold, etc. However, the present application is not limited to the metal materials listed here, and in other alternative embodiments, metal materials other than those listed here can also be used. The guide block can adopt a nickel-titanium composite material, for example, a wire material containing platinum or tantalum developing metal inside the nickel-titanium (e.g., platinum core nickel-titanium composite wire). Similarly, the limiting member 14 can adopt a nickel-titanium alloy, a nickel-titanium composite material, a platinum-tungsten alloy or a platinum-iridium alloy, etc. In another alternative embodiment, the guide block 13 and the limiting member 14 can also be a high polymer polymer pipe doped with a developing agent, for example, can be a polyamide or nylon pipe doped with a developing agent, and the developing agent can be barium salt, bismuth salt, tungsten salt, metallic tungsten, metallic bismuth, metallic barium, etc.

[0062] Figure 4FIG. 2 is a schematic diagram of the distal end of the scoring guidewire 1b of the second embodiment of the present application. In the second embodiment, the guidewire shaft 11b can be a 0.014 inch guidewire, and the material of the distal end portion of the guidewire shaft 11b can be a nickel-titanium alloy or a nickel-titanium composite material 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 helically bent to form a helical coil structure, which is the cutting unit 12b of the scoring guidewire 1b. The radius and spacing of the helical coils in the helical coil structure are varied to cause the cutting unit to be in an expanded state or a compressed state. The helical coil structure can be formed by heat setting and pre-shaping the wire material, and at this time, the cutting unit 12b and the guidewire shaft 11b are integrated, i.e., the helical coil structure and the guidewire shaft 11b are integrally made of the same wire material. In the second embodiment, the wire material that forms the cutting unit 12b has one end that is not fixed, and the end that is not fixed is located at the proximal end of the cutting unit 12b. At this time, one or more helical coils at the proximal end of the helical coil structure (i.e., the end that is not fixed) form a ring structure 122b of the cutting unit 12b. When the scoring guidewire 1b of the second embodiment is used in cooperation with a balloon catheter, the balloon body of the balloon catheter can enter the interior of the cutting unit 12b through the ring structure 122b, and when the balloon body is inflated to an expanded state, the radius of the helical coils of the helical coil structure increases, and the cutting unit 12b also correspondingly enters an expanded state.

[0063] The cutting unit of the scoring guidewire is not limited to the helical coil structure in the second embodiment, and can be other expandable structures, such as other structures that include helical coils. Figure 5 FIG. 3 is a schematic diagram of the distal end of the scoring guidewire 1c of the third embodiment of the present application. Unlike the second embodiment, the distal end of the guidewire shaft 11c is not fixed, i.e., the end of the wire material that is not fixed is located at the distal end of the cutting unit 12c, and one or more helical coils at the proximal end of the cutting unit 12c form a ring structure 122c of the cutting unit 12c. The other structures and material settings of the scoring guidewire 1c of the third embodiment can refer to the second embodiment. Similarly, when the scoring guidewire 1c of the third embodiment is used in cooperation with a balloon catheter, the balloon body of the balloon catheter can enter the interior of the cutting unit 12c through the ring structure 122c, and when the balloon body is inflated to an expanded state, the radius of the helical coils of the helical coil structure increases, and the cutting unit 12c also correspondingly enters an expanded state.

[0064] In the second embodiment and the third embodiment, the radius and spacing of the helical coils in the helical coil structure can be designed and adjusted according to the size and length of the plaque at the lesion site. Preferably, the cross section of the wire material at the helical coil structure is triangular, trapezoidal, or other polygonal with corners.

[0065] The score guide wire of the application is suitable for treating lesions of intracranial tortuous blood vessels and other blood vessels, such as peripheral blood vessels, cardiovascular blood vessels and the like. Since the score guide wire is designed with a cutting unit having a ring structure, when the score guide wire reaches the lesion position, a conventional balloon catheter can be directly used for expansion, the cutting unit on the score guide wire is expanded by the expansion of the balloon body, so as to force the score wire of the cutting unit to extrude and destroy the blood vessel plaque, thereby effectively treating CTO lesions and other more serious blood vessel calcification lesions. The cross section of the score guide wire of the application is significantly smaller than that of the cutting balloon, has excellent flexibility and passability, and can pass through tortuous or severely stenotic blood vessels, so that it is not necessary to additionally use a special balloon such as a CTO balloon for pre-expansion, thereby reducing the operation steps, reducing the damage to the blood vessels during the operation, and reducing the operation complications.

[0066] The application further provides a score balloon assembly, which comprises any one of the score guide wires and a balloon catheter 2; the balloon catheter 2 is configured to be sleeved on the guide wire shaft 11 of the score guide wire 1 and is movable along the guide wire shaft 11, and comprises an inner lumen tube, an outer tube and a balloon body; the distal end of the inner lumen tube penetrates through the balloon body, and the distal end of the balloon body is connected with the distal end of the inner lumen tube; the outer tube is connected with the proximal end of the balloon body and is sleeved outside the inner lumen tube. The space between the inner lumen tube and the outer tube and the space between the inner lumen tube and the balloon body are used for inflation or liquid filling to make the balloon expand under pressure and contract under pressure.

[0067] Figures 6 to 8This is a schematic diagram of the various states of a scoring balloon assembly according to an embodiment of the present invention. In this embodiment, the scoring guidewire in the scoring balloon assembly is the same as that in the first embodiment, that is, the scoring guidewire also includes a guide block 13 and a limiting member 14 sleeved on the guidewire shaft 11; the distal tube 21 of the balloon catheter 2 can pass over the outer edge of the limiting member 14 and abut against the abutment section 133 of the guide block 13, so that the distal end of the balloon catheter 2 (e.g., part or all of the balloon body) can enter the cutting unit and cause the cutting unit to enter the expansion state, ultimately achieving the treatment of vascular calcification lesions. For example, the limiting member 14 is cylindrical, and the inner diameter of the distal tube 21 of the balloon body should be larger than the outer diameter of the cylindrical limiting member 14. At the same time, the inner diameter of the distal tube 21 of the balloon body needs to be smaller than the outer diameter of the proximal end of the variable diameter section 132 of the guide block 13 (i.e., the maximum outer diameter of the guide block 13). At this time, the movement of the balloon catheter 2 in the distal direction can drive the guide block 13 to move in the distal direction. It should be noted that the distal tube 21 and the distal end of the inner lumen tube can be integral. In this case, the distal tube 21 is the inner lumen tube at the distal end of the balloon catheter 2, or the farthest end of the inner lumen tube. In some other embodiments, the distal tube 21 can also be a segment connected to the distal end of the inner lumen tube, constituting the farthest 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 greater than the maximum outer diameter of the limiting member 14 and less than the maximum outer diameter of the guide block 13. When the balloon catheter 2 moves distally relative to the scoring guidewire, the distal end of the balloon catheter 2 passes over the limiting member 14 and abuts against the proximal end of the guide block 13. Under the guidance of the guide block 13, it 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 this time, the balloon body is located in the cutting unit 12. When the balloon enters the cutting unit 12 through the annular structure and is inflated, the cutting unit 12 expands. When the balloon is depressurized, the cutting unit 12 returns to or substantially returns to its compressed state. Furthermore, the distal end of the balloon catheter 2 and the proximal end of the guide block 13 are preferably tightly fitted, so that when the balloon catheter 2 is retracted proximally, the guide block 13 can be withdrawn from the cutting unit, reducing the outer diameter of the cutting unit during retraction. When using this notched balloon assembly, the notched guidewire 1 is pushed to the lesion plaque 91 of the vessel 9 using a direct pushing method or with the aid of a matching guide catheter. Figure 6 As shown, at this point, the etched guidewire 1 should pass through the lesion plaque 91 (the guiding catheter can be removed if necessary); then the balloon catheter 2 is pushed along the guidewire axis 11. When the balloon body of the balloon catheter 2 is pushed to the limiting element 14 of the etched guidewire, the inner diameter of the distal tube 21 of the balloon body crosses the limiting element 14 and abuts against the guiding block 13. The distal tube 21 of the balloon body and the abutting section 133 of the guiding block 13 fit tightly together, as shown. Figure 7shown; 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 taper structure of the variable diameter section 132 of the guide block 13, when the guide block 13 passes through the cutting unit 12, the guide block 13 will slightly expand the annular structure 122 of the proximal end of the cutting unit 12, the balloon body follows the guide block 13 into the inside of the cutting unit 12, continue to push the balloon body until the circular ring section 131 of the guide block 13 abuts against the distal end of the cutting unit 12, the balloon body reaches the predetermined position, as shown Figure 8 At this time, the balloon body is directly inflated for expansion, the score wire on the cutting unit 12 is expanded to the expanded state by the balloon expansion, so as to force the score wire to extrude and damage the blood vessel plaque. After the operation of cutting the plaque is completed, the balloon body is deflated, and the balloon catheter 2 is withdrawn, due to the close fit between the distal tube 21 of the balloon catheter 2 and the abutting section 133 of the guide block 13, the guide block 13 will follow the balloon body to retreat until it contacts the limiting piece 14 and is blocked by the limiting piece 14, 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, the score guide wire is withdrawn. When the intracranial blood vessel or other tortuous blood vessel is treated, the step of withdrawing can be assisted by a microcatheter or a matching guide catheter.

[0068] The score guide wire of the present application can pass through the intracranial tortuous blood vessel to reach the intracranial calcified lesion position, and then a conventional balloon catheter is used to follow the score guide wire to pass through the lesion to reach the score wire position. Due to the fact that the distal end of the score guide wire is provided with a cutting unit, the balloon body of the balloon catheter can cut the calcified lesion in the angioplasty process through the score wire of the cutting unit when the balloon body is expanded, so that the effect of expansion is enhanced. By using the score balloon assembly of the present application, the treatment of the intracranial moderately calcified lesion blood vessel can be realized by using a conventional balloon.

[0069] When the score guide wire 1 is not matched with the guide catheter 4, the score guide wire 1 is preloaded in the protection catheter 3, and in the operation, the cutting unit of the score guide wire is delivered to the blood vessel lesion position, and the use method is the same as that of the commonly used guide wire; for the intracranial blood vessel or other tortuous blood vessel, other instruments can be used, which can be a 0.021 inch microcatheter.

[0070] The present application also provides an interventional device, which comprises a guide catheter and the above-mentioned score guide wire which can move in the guide catheter. In another embodiment, the interventional device comprises a guide catheter, the above-mentioned score guide wire 1 and a balloon catheter 2, the score guide wire 1 and the balloon catheter 2 are movably arranged in the guide catheter, and the balloon catheter 2 is sleeved on the guide wire shaft 11 of the score guide wire 1 and is movable along the guide wire shaft 11. The score guide wire 1 can be preloaded in the guide catheter 4 when necessary, see Figure 9After the scoring guidewire 1 is delivered to the lesion site by 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, so that the cutting unit and the balloon catheter are combined for use.

[0071] In some embodiments, the guide catheter 4 comprises a delivery section 41 at one end and a retrieval section 42 at the other end, Figure 10 The delivery section 41 is softer than the retrieval section 42, i.e. the delivery section 41 is more flexible, and the different stiffness of the two sections makes the entire scoring guidewire more flexible and easier to push and retrieve. Preferably, the free end of the delivery section 41 is a flexible section 41A to prevent scratching of the small and tortuous blood vessels at the distal end 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 scoring guidewire 1. Specifically, when the scoring guidewire 1 needs to be delivered from outside the body to the lesion site for treatment, the delivery section 41 as the distal end of the guide catheter 4 enters the body first and delivers the cutting unit 12 at the distal end of the scoring guidewire 1 to the lesion blood vessel section, and the softer delivery section 41 ensures the safety of the delivery process, while the retrieval section 42 is at the proximal end (closer to the operator). When the scoring guidewire 1 needs to be withdrawn from the lesion site to the outside of the body, the retrieval section 42 as the distal end of the guide catheter 4 enters the body, and the relatively higher stiffness of the retrieval section 42 makes the distal end of the guide catheter 4 more supportive, making the retrieval of the entire scoring guidewire 1, especially the cutting unit 12, easier, and the flared structure 42A facilitates the retrieval of the loop structure at the proximal end of the cutting unit 12 into the guide catheter 4. The difference in stiffness between the retrieval section 42 and the delivery section 41 can be achieved by using different materials or different material compositions, for example, the retrieval section 42 and the delivery section 41 can be made of different Shore hardness polyether block amide (PEBAX), such as PEBAX6333 (Shore D hardness 64) for the retrieval section 42 and PEBAX3533 (Shore D hardness 33) for the delivery section 41. The difference in stiffness between the retrieval section 42 and the delivery section 41 can also be achieved by using different structures and / or dimensions, for example, the retrieval section 42 is a double-layer tube with a metal braid layer in the middle, and the delivery section 41 is a single-layer tube.

[0072] The foregoing is considered as further explanation of the application in connection with the preferred embodiments, and cannot be deemed as limitation of the specific implementation of the application to these descriptions. It is obvious for those skilled in the art that the present application is not limited to the details of the above exemplary embodiments, and can be realized in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be regarded as exemplary and non-limiting, and the scope of the present application is defined by the appended claims rather than the above description, and all changes falling within the meaning and range of equivalent elements of the claims are intended to be embraced in the present application. Any reference signs in the claims should not be deemed as limiting the claims to which they relate.

Claims

1. A score guide, comprising: The scoring guide wire 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 guide wire is configured such that, when the scoring guide wire is matched with a balloon catheter, the distal end of at least part of the balloon catheter enters the inside of the cutting unit through the ring structure.

2. The score guide wire of claim 1 wherein, The scoring guide wire further comprises a guide block and a limiting piece arranged on the guide wire shaft. The limiting piece is fixed to the guide wire shaft and located proximally to the cutting unit. The guide block is configured to reciprocally move between the limiting piece and the distal end of the cutting unit, and when moving, the guide block enters the cutting unit through the ring structure.

3. The score guide wire of claim 2 wherein, The maximum outer diameter of the limiting piece is greater than the minimum inner diameter of the guide block.

4. The score guide wire of claim 2 wherein, The cutting unit comprises a plurality of scoring wires, the distal end of each scoring wire is fixedly connected to the guide wire shaft, and the proximal end of each scoring wire is arranged on the ring structure.

5. The score guide wire of claim 4 wherein, Each scoring wire comprises a plurality of wire rods; and / or The cross section of the scoring wire is triangular, rectangular, trapezoidal or other polygonal shape; and / or The plurality of scoring wires are in spiral structure, parallel arrangement structure or grid structure; and / or The plurality of scoring wires are obtained by laser cutting integral molding process or woven to form the cutting unit; 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 by heat setting process.

6. The score guide of claim 1 wherein, The ring structure is composed of a plurality of wave-shaped metal rods connected end to end.

7. The score guide wire of claim 2 wherein, The guide block comprises, from distal end to proximal end, a circular ring segment, a variable diameter segment and an abutting segment, and the diameter of the variable diameter segment gradually increases in the direction from distal end to proximal end.

8. The score guide wire of claim 2 wherein, The guide block is made of a developing material; and / or The limiting piece is made of a developing material.

9. The score guide of any of claims 1-8, wherein, The cutting unit comprises a spiral coil structure formed by spiral bending around the guide wire shaft, and the spiral coil structure and the guide wire shaft are integrally made of the same wire material.

10. The score guide wire of claim 9 wherein, The material of the spiral coil structure comprises nickel-titanium alloy or nickel-titanium composite material, and the spiral coil structure is formed by heat setting pre-molding.

11. A scoring balloon assembly characterized by, The scoring guide wire and the balloon catheter are matched, the balloon catheter is arranged on the guide wire shaft of the scoring guide wire and is movable along the guide wire 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 penetrates 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 arranged outside the inner lumen tube. When the balloon body enters the inside of the cutting unit through the ring structure and is inflated, the cutting unit of the scoring guide wire is expanded, and when the balloon body is deflated, the cutting unit is compressed.

12. The scoring balloon assembly of claim 11, wherein, The scoring guide wire further comprises a guide block and a limiting piece arranged on the guide wire shaft. The limiting piece is fixed to the guide wire shaft and located proximally to the cutting unit. The guide block is configured to be reciprocally movable between the stopper and the distal end of the cutting unit, and when moving, the guide block enters the cutting unit through the annular structure; When the balloon catheter moves distally relative to the scoring guidewire, the distal end of the balloon catheter passes the stopper and abuts against the proximal end of the guide block.

13. The scoring balloon assembly of claim 12, wherein, The inner diameter of the inner lumen tube of the distal end of the balloon catheter is greater than the maximum outer diameter of the stopper and less than the maximum outer diameter of the guide block, and the distal end of the balloon catheter is tightly fitted with the proximal end of the guide block.

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

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