Drug-coated scoring balloon and balloon catheter

Abstract

Provided in the present application are a drug-coated scoring balloon and a balloon catheter. A drug storage cavity and a drug output channel are formed in a sheath, such that when the sheath is pressed at a lesion site, a scoring member extends out of the sheath, the space of the drug storage cavity gradually decreases, and due to the pressing, a drug is released onto the surface of a balloon body through the drug storage cavity and the drug output channel. In such a design, compared to a previous drug balloon, during the delivery of the drug-coated scoring balloon to the lesion site, normal vascular tissue does not come into contact with the drug, thereby preventing loss of the drug during the balloon delivery process; it is only when the balloon body reaches the lesion site and expands and the sheath is then pressed at the lesion site that the drug can be released, such that a quantitative or an adequate amount of the drug can reach the lesion site; moreover, the design of additionally providing the sheath on the scoring member allows the sheath to protect the scoring member during the delivery of the balloon to the lesion site and during the production of the balloon, thereby preventing the scoring member from injuring normal tissue.

Description

Drug-loaded scored balloon and balloon catheter

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the China Patent Office on April 26, 2024, with application number 202410508940.5 and invention name “A Drug-Loaded Scored Balloon and Balloon Catheter”, the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application belongs to the field of medical device technology, and in particular relates to a drug-loaded scored balloon and a balloon catheter. Background Art

[0004] For many years, blocked arteries have become a major medical problem. This is because blocked arteries reduce blood flow through them, leading to a variety of serious complications. Arterial narrowing is primarily caused by the accumulation of cholesterol, calcium, and fibrotic tissue, and angioplasty is perhaps the most commonly used treatment. Angioplasty involves using an inflatable balloon to dilate the blocked artery, but this treatment option is associated with a high rate of restenosis.

[0005] To address the above-mentioned issues, scored balloons have emerged. The scored elements on the balloons can cut through stenosis during angioplasty to enhance the effectiveness of stenosis dilation. Some scored balloons also form a drug coating on the balloon surface, releasing therapeutic drugs at the lesion site. The drugs diffuse into the tissue of the diseased blood vessel wall, achieving a better effect of inhibiting intimal hyperplasia and achieving a better lumen dilation effect during the treatment of the lesion. Existing scored balloons form a drug coating on the balloon surface. As the drug is transported to the lesion site with the balloon, it is continuously lost and carried away by the bloodstream. This results in normal vascular tissue coming into contact with the drug, while a serious shortage of drugs can reach the lesion site. Furthermore, the scored elements can easily scratch normal vascular tissue during delivery to the lesion site.

[0006] Therefore, how to avoid drug loss during the delivery of the drug-loaded scored balloon to the lesion site, while preventing the scoring element from scratching normal vascular tissue during the delivery to the lesion site, is an urgent problem to be solved by those skilled in the art.

[0007] Summary of the Invention

[0008] The purpose of the present application is to provide a drug-loaded scored balloon and a balloon catheter, which can effectively avoid the loss of drugs during the delivery of the drug-loaded scored balloon to the lesion site, and prevent the scoring member from scratching normal vascular tissue during the delivery to the lesion site.

[0009] To solve the above technical problems, the present application provides a drug-loaded scored balloon, comprising:

[0010] Balloon body;

[0011] a scoring member, the scoring member being provided on the outer wall of the balloon body and arranged along an axial direction parallel to the balloon body;

[0012] a sheath, wherein the bottom end of the sheath is connected to the balloon body, the top end of the sheath is covered with the notched member, a first breaking line is provided at a position opposite to the notched member, the first breaking line is configured to break when the sheath is squeezed, the interior of the sheath is provided with a drug storage cavity for storing drugs and a drug outlet channel for releasing drugs to the outside, the two ends of the drug outlet channel respectively communicating with the outside and the drug storage cavity;

[0013] When the balloon body reaches the lesion location and expands, the top end of the sheath is squeezed by the inner wall of the blood vessel. As the space of the drug storage cavity gradually decreases, the drug is discharged to the surface of the balloon body through the drug storage cavity and the drug outlet channel. At the same time, the first breaking line at the top end of the sheath breaks, causing the top end of the notched member to protrude from the sheath.

[0014] Optionally, in the above-mentioned drug-loaded scored balloon, a protective film is provided at the port of the drug outlet channel communicating with the outside world, and a second breaking line is provided on the protective film, and the second breaking line is used to break when the sheath is squeezed.

[0015] Optionally, in the above-mentioned drug-loaded scored balloon, a mounting cavity is provided inside the sheath, a sliding seat is provided at the bottom of the mounting cavity, and a sliding groove member is provided at the bottom of the scoring member to slide with the sliding seat;

[0016] In the initial state, the notched part is located at the top of the mounting cavity, and the drug storage cavity is formed between the slide groove part of the notched part and the slide seat and / or between the slide seat and the side wall of the mounting cavity; when the balloon body reaches the lesion position and expands, and the top end of the sheath is squeezed by the inner wall of the blood vessel, the notched part moves toward the slide seat, and the space of the drug storage cavity gradually decreases.

[0017] Optionally, in the above-mentioned drug-loaded scored balloon, the cross-section of the slide is T-shaped, the slide member includes two parallel flat plates and a limiting plate arranged on the bottom side of the flat plate, the top of the flat plate is connected to the scored member, and the limiting plate is used to abut against the top end of the slide to achieve limitation.

[0018] Optionally, the above-mentioned drug-loaded scored balloon further includes a guide tube, which is arranged on the side of the sheath and laid on the outer wall of the balloon body. One end of the guide tube is connected to the drug outlet channel and a plurality of through holes are opened on the side wall.

[0019] Optionally, in the above-mentioned drug-loaded scored balloon, a mounting cavity is provided inside the sheath, the scoring member is provided at the bottom of the mounting cavity, and the drug storage cavity is formed between the scoring member and the mounting cavity of the sheath.

[0020] Optionally, in the above-mentioned drug-loaded scored balloon, an installation cavity is provided inside the sheath, the installation cavity is covered with the scored member, and the drug storage cavity is provided on the side of the scored member.

[0021] Optionally, in the above-mentioned drug-loaded scored balloon, the drug outlet channel includes a buffer cavity and a drug outlet through hole, and the two ends of the buffer cavity are respectively connected to the drug storage cavity and the drug outlet through hole. When the balloon body reaches the lesion position and expands, the top end of the sheath is squeezed by the inner wall of the blood vessel. As the space of the drug storage cavity gradually decreases, the drug is discharged to the surface of the balloon body through the drug storage cavity, the buffer cavity and the drug outlet through hole in turn.

[0022] Optionally, in the above-mentioned drug-loaded scored balloon, the drug outlet channels are multiple and arranged along the length direction of the sheath, and / or the drug outlet channels are distributed on both sides of the sheath, and / or the number of buffer cavities in each drug outlet channel is multiple, and the multiple buffer cavities are interconnected, and / or the drug outlet holes in each drug outlet channel are multiple and arranged along the height direction of the sheath.

[0023] The present application also provides a balloon catheter, comprising the drug-loaded scored balloon as described above.

[0024] The present application provides a drug-loaded scored balloon, which has the following beneficial effects:

[0025] By forming a drug storage cavity and a drug discharge channel in the sheath, when the sheath is squeezed by the lesion site, the scoring part extends from the sheath, and the space of the drug storage cavity gradually decreases. Due to the squeezing, the drug is released to the surface of the balloon body through the drug storage cavity and the drug discharge channel. Compared with previous drug balloons, this design does not allow normal vascular tissue to come into contact with the drug during the transportation of the drug-loaded scored balloon to the lesion site, thereby avoiding the loss of drug during the transportation of the drug-loaded scored balloon. Only when the drug-loaded scored balloon reaches the lesion site and the balloon body expands, the lesion site squeezes the sheath, and the drug can be released, which enables the drug to reach the lesion site in a quantitative or sufficient amount. At the same time, the design of adding a sheath to the scoring part allows the sheath to protect the scoring part during the transportation of the drug-loaded scored balloon to the lesion site and during the production of the drug-loaded scored balloon, preventing the scoring part from damaging normal tissue.

[0026] The present application also provides a balloon catheter having the above-mentioned drug-loaded scored balloon, which has the same beneficial effects and will not be further described here. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without any creative work.

[0028] FIG1 is a schematic structural diagram of a drug-loaded scored balloon provided in Example 1 of the present application;

[0029] FIG2 is a front view of a drug-loaded scored balloon provided in Example 1 of the present application;

[0030] FIG3 is a schematic cross-sectional view of a drug-loaded scored balloon provided in Example 1 of the present application before deformation;

[0031] FIG4 is a partial enlarged view of point A in FIG3;

[0032] FIG5 is a schematic cross-sectional view of a drug-loaded scored balloon after deformation provided in Example 1 of the present application;

[0033] FIG6 is a partial enlarged view of point B in FIG5;

[0034] FIG7 is a cross-sectional schematic diagram of the sheath provided in Example 1 of the present application;

[0035] FIG8 is a front view of the scoring member provided in Example 1 of the present application;

[0036] FIG9 is a schematic cross-sectional view of FIG8 taken along the AA line;

[0037] FIG10 is a schematic structural diagram of a drug-loaded scored balloon provided in Example 2 of the present application;

[0038] FIG11 is a front view of a drug-loaded scored balloon provided in Example 2 of the present application;

[0039] FIG12 is a schematic cross-sectional view of a drug-loaded scored balloon provided in Example 2 of the present application before deformation;

[0040] FIG13 is a partial enlarged view of point C in FIG12;

[0041] FIG14 is a schematic cross-sectional view of a drug-loaded scored balloon after deformation provided in Example 2 of the present application;

[0042] FIG15 is a partial enlarged view of point D in FIG14;

[0043] FIG16 is a schematic structural diagram of a drug-loaded scored balloon provided in Example 3 of the present application;

[0044] FIG17 is a front view of a drug-loaded scored balloon provided in Example 3 of the present application;

[0045] FIG18 is a schematic cross-sectional view of a drug-loaded scored balloon provided in Example 3 of the present application before deformation;

[0046] FIG19 is a partial enlarged view of point E in FIG18;

[0047] FIG20 is a schematic cross-sectional view of a drug-loaded scored balloon after deformation provided in Example 3 of the present application;

[0048] FIG21 is a partial enlarged view of point F in FIG20;

[0049] FIG22 is a schematic structural diagram of a drug-loaded scored balloon provided in Example 4 of the present application;

[0050] FIG23 is a front view of a drug-loaded scored balloon provided in Example 4 of the present application;

[0051] FIG24 is a schematic cross-sectional view of a drug-loaded scored balloon provided in Example 4 of the present application before deformation;

[0052] FIG25 is a partial enlarged view of FIG24 at G;

[0053] FIG26 is a schematic cross-sectional view of a drug-loaded scored balloon after deformation provided by Example 4 of the present application;

[0054] FIG27 is a partial enlarged view of point H in FIG26 .

[0055] In the above drawings: 1-balloon body; 2-scoring member; 201-sliding groove member; 3-sheath; 301-drug storage cavity; 302-buffer cavity; 303-guide tube; 304-sliding seat. DETAILED DESCRIPTION

[0056] The following describes in detail embodiments of the present application. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application and are not to be construed as limiting the present application.

[0057] Throughout the description of this application, it should be understood that the terms "proximal" and "distal" refer to the near and far ends relative to the operator. In this application, the end closest to the physician or operator is the "proximal end," i.e., the end where the operator is located, and the end away from the physician or operator is the "distal end," i.e., the end where the balloon is located. The above-mentioned descriptions of orientations are merely for the purpose of facilitating the description of this application and simplifying the description. They are not intended to indicate or imply that the device or component referred to must have, be constructed, or operate in a specific orientation, and are therefore not to be construed as limiting this application.

[0058] The core of this application is to provide a drug-loaded scored balloon and a balloon catheter, which can effectively avoid the loss of drugs during the delivery of the drug-loaded scored balloon to the lesion site, and at the same time prevent the scoring part from scratching normal vascular tissue during the delivery to the lesion site.

[0059] In order to enable those skilled in the art to better understand the technical solutions provided by this application, this application will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0060] Specifically, please refer to Figures 1 to 27. The drug-loaded scored balloon disclosed in the embodiments of the present application includes: a balloon body 1, a scoring member 2 and a sheath 3.

[0061] Among them, the scoring member 2 is provided on the outer wall of the balloon body 1 and is arranged along the axial direction parallel to the balloon body 1. It should be noted that the scoring member 2 is provided on the outer wall of the balloon body 1, which does not only mean that the scoring member 2 is fixed on the outer wall of the balloon body 1, but refers to the spatial positional relationship between the two, not a fixed relationship. That is, the scoring member 2 is arranged on the outer wall of the balloon body 1, which should be understood as the scoring member 2 being located on the outside of the balloon body 1. Specifically, the scoring member 2 can be directly fixed on the outer wall of the balloon body 1, or it can be indirectly provided on the outer wall of the balloon body 1 through other components. For example, the scoring member 2 can be provided on the sheath 3, and the sheath 3 can be provided on the outer wall of the balloon body 1, which can also achieve the effect of providing the scoring member 2 on the outer wall of the balloon body 1.

[0062] The balloon body 1 can be a cylindrical structure with two tapered ends. The cylindrical structure is the working section, and the tapered ends are the non-working sections. A developing ring is provided on the outer surface of the inner tube corresponding to the balloon body 1, which can be used to locate the balloon body 1 at the lesion site.

[0063] The scoring piece 2 can be set in the middle cylindrical part of the balloon body 1, arranged along the axial direction parallel to the balloon body 1, and can be fixed by gluing. It should be noted that in the solution where the scoring piece 2 is slidable, the scoring piece 2 does not need to be fixed with glue.

[0064] The number of scoring elements 2 is n, where n is an integer greater than or equal to 1. When there are multiple scoring elements 2, they can be evenly arranged on the circumferential direction of the outer surface of the balloon body 1, and the angle between any two adjacent scoring elements 2 in the circumferential direction is 360° / n. Optionally, the number of scoring elements 2 is 3, which means that the angle between any two adjacent scoring elements 2 in the circumferential direction is 120°.

[0065] When there are multiple scoring elements 2, there are also multiple sheaths 3, which correspond one to one with the scoring elements 2. The bottom end of the sheath 3 is connected to the balloon body 1, and the top end is covered with the scoring element 2. That is, in the initial state, the scoring element 2 is covered by the sheath 3, so that the entire scoring element 2, especially the cutting edge of the scoring element 2, is not exposed.

[0066] A first breaking line is provided at the top of the sheath 3, opposite the scoring element 2. This first breaking line is designed to break the sheath when squeezed. Typically, the blade of the scoring element 2 is located on the side of the scoring element 2 facing away from the balloon body 1. To ensure reliable rupture of the sheath 3 when squeezed, the first breaking line is positioned corresponding to the blade of the scoring element 2. When the sheath 3 is squeezed, the blade of the scoring element 2 can sever the first breaking line, assisting in its severance.

[0067] The sheath 3 is internally provided with a drug storage cavity 301 for storing medication and a drug outlet channel for releasing the medication to the outside world. The two ends of the drug outlet channel connect the outside world to the drug storage cavity 301, respectively. This allows the medication stored in the drug storage cavity 301 to be discharged to the outside world through the drug outlet channel when the space in the drug storage cavity 301 decreases or the pressure increases. It should be noted that the medication can be injected into the end of the sheath 3, which is then sealed. The medication is sealed in the drug storage cavity 301 and can only be expelled through the drug outlet channels on both sides of the sheath 3.

[0068] When the balloon body 1 reaches the lesion location and expands, the top of the sheath 3 will be squeezed by the inner wall of the blood vessel, driving the top of the sheath 3 to move toward the balloon body 1, and then the space of the drug storage cavity 301 gradually decreases. As the space of the drug storage cavity 301 gradually decreases, the drug stored in the drug storage cavity 301 is discharged to the surface of the balloon body 1 through the drug outlet channel. At the same time, the first breaking line at the top of the sheath 3 breaks, causing the top of the notched member 2 (at least the blade of the notched member 2) to extend from the sheath 3.

[0069] It should be noted that the purpose of providing the first break line on the sheath 3 is that, when the balloon body 1 has not reached the designated position, the sheath 3 covers the entire scoring element 2, preventing the scoring element 2 from contacting the vascular tissue, preventing the scoring element 2 from injuring the human body, and facilitating storage and transportation. When the balloon body 1 reaches the lesion site and expands, and the top end of the sheath 3 is squeezed by the inner wall of the blood vessel, the first break line can break, exposing the scoring element 2 from within the sheath 3. The first break line is specifically arranged in a direction parallel to the axis of the balloon body 1. That is, when the sheath 3 breaks along the first break line, the sheath 3 is separated into two halves, thereby exposing the scoring element 2 inside.

[0070] The drug-loaded scored balloon disclosed in the embodiment of the present application forms a drug storage cavity 301 and a drug outlet channel in the sheath 3. When the sheath 3 is squeezed by the lesion site, the scored member 2 extends from the sheath 3, and the space of the drug storage cavity 301 is reduced. Due to the squeezing, the drug is released to the surface of the balloon body 1 through the drug storage cavity 301 and the drug outlet channel. Compared with previous drug balloons, this design does not allow normal vascular tissue to come into contact with the drug during the transportation of the drug-loaded scored balloon to the lesion site, thereby avoiding the loss of drug during the transportation of the drug-loaded scored balloon. Only when the drug-loaded scored balloon reaches the lesion site and the balloon body 1 expands, the lesion site squeezes the sheath 3, and the drug can be released, which enables the drug to reach the lesion site in a quantitative or sufficient amount. At the same time, the design of adding the sheath 3 to the scored member 2 allows the sheath 3 to protect the scored member 2 during the transportation of the drug-loaded scored balloon to the lesion site and during the production of the drug-loaded scored balloon, thereby preventing the scored member 2 from damaging normal tissue.

[0071] It should be noted that the drug outlet channel can be a hole with a smaller diameter, that is, the aperture on the outlet side of the drug outlet channel should be able to be blocked by surface tension. When the drug is liquid, surface tension will be formed on the outlet side surface of the drug outlet channel under natural conditions. When the sheath 3 is not squeezed, the drug will not flow out of the drug outlet channel under the action of surface tension.

[0072] When the drug outlet channel is a hole with a relatively large diameter, the surface tension formed is not enough to seal the drug in the drug storage cavity 301 and prevent it from leaking out; based on this, in a specific embodiment, a protective film is provided at the port of the drug outlet channel that is connected to the outside world. In this way, it can be ensured that the drug will not flow out of the drug outlet channel under natural conditions. Only when the sheath 3 is squeezed can the drug flow out of the drug outlet channel.

[0073] To ensure that the drug can flow reliably out of the drug outlet channel when the sheath 3 is squeezed, a second break line is provided on the protective film. When the sheath 3 is squeezed, the space in the drug storage cavity 301 is reduced, and the drug squeezes the protective film, causing the second break line to break. The working principle of the second break line is similar to that of the first break line, and there can be multiple second break lines.

[0074] There are various ways to arrange the scoring member 2 within the sheath 3. In one embodiment, the sheath 3 has a mounting cavity disposed therein, a slide seat 304 disposed at the bottom of the mounting cavity (as shown in FIG7 , the bottom of the mounting cavity is the side of the mounting cavity close to the balloon body 1), and a slide groove 201 is disposed at the bottom of the scoring member 2, which slides radially with the slide seat 304 along the balloon body 1.

[0075] In the initial state, the scoring member 2 is located at the top of the installation cavity. Specifically, the scoring member 2 can be restrained at the top of the installation cavity by the sheath 3. A drug storage cavity 301 is formed between the sliding groove 201 of the scoring member 2 and the sliding seat 304 and / or between the sliding seat 304 and the side wall of the installation cavity for storing drugs. Because the scoring member 2 is located at the top of the installation cavity, there is a large space between the sliding groove 201 and the sliding seat 304 to accommodate drugs. There is also a certain amount of space between the sliding seat 304 and the side wall of the installation cavity to store drugs.

[0076] When the balloon body 1 reaches the lesion site and expands, and the top of the sheath 3 is squeezed by the inner wall of the blood vessel, the scoring member 2 moves toward the slide 304 under the guidance of the slide member 201 (because the slide 304 is located on the side of the installation cavity close to the balloon body 1, the scoring member 2 moves toward the side of the installation cavity close to the balloon body 1 under the guidance of the slide member 201), and the space in the drug storage cavity 301 gradually decreases. That is, the scoring member 2 moves toward the balloon body 1 under the sliding cooperation between the slide member 201 and the slide 304, causing the space between the slide member 201 and the slide 304 to gradually decrease. At the same time, the slide member 201 gradually occupies the space between the slide 304 and the side wall of the installation cavity, causing the space volume here to gradually decrease. Therefore, the space in the drug storage cavity 301 gradually decreases as the scoring member 2 moves.

[0077] As shown in Figures 7 to 9, the cross-section of the slide 304 is T-shaped, and the slide member 201 includes two parallel flat plates and a limit plate arranged on the bottom side of the flat plate (i.e., the side facing the balloon body 1). The top of the flat plate is connected to the notching member 2, and the limit plate is used to abut against the top bottom of the slide 304, which can limit the up and down movement of the notching member 2 to prevent the notching member 2 from falling off.

[0078] As shown in FIG. 18 to FIG. 21 , in another specific embodiment, a mounting cavity is provided inside the sheath 3 , a notched member 2 is provided at the bottom of the mounting cavity, and a medicine storage cavity 301 is formed between the notched member 2 and the mounting cavity of the sheath 3 .

[0079] As shown in FIG. 24 to FIG. 27 , in another specific embodiment, a mounting cavity is provided inside the sheath 3 , the mounting cavity is covered with the scoring member 2 , and the medicine storage cavity 301 is provided on the side of the scoring member 2 .

[0080] As shown in Figures 12-15, this solution may also include a guide tube 303, which is positioned on the side of the sheath 3 and laid on the outer wall of the balloon body 1. One end of the guide tube 303 is connected to the drug outlet channel, and the side wall is provided with multiple through holes. There are multiple guide tubes 303, one for each drug outlet channel. The multiple through holes on both sides of the guide tube 303 allow the expansion of the balloon body 1 and the compression of the top of the sheath 3 against the inner wall of the blood vessel, reducing the space in the drug storage cavity 301. The drug is then discharged onto the surface of the balloon body 1 via the drug storage cavity 301, the drug outlet channel, and the guide tube 303.

[0081] In order to prevent the sheath 3 from being slightly squeezed and causing the internal medicine to be sprayed out to the outside, the drug outlet channel includes a buffer chamber 302 and a drug outlet through hole. The two ends of the buffer chamber 302 are respectively connected to the drug storage chamber 301 and the drug outlet through hole. Specifically, the buffer chamber 302 and the drug storage chamber 301 can be connected through some small holes. When the balloon body 1 reaches the lesion site and expands, the top of the sheath 3 is squeezed by the inner wall of the blood vessel. As the space of the drug storage chamber 301 gradually decreases, the medicine is discharged to the surface of the balloon body 1 through the drug storage chamber 301, the buffer chamber 302 and the drug outlet through hole in turn. In the initial state, there is no medicine in the buffer chamber 302 and the drug outlet through hole, and the buffer chamber 302 is part of the drug outlet channel. The protective film and the second breaking line mentioned above are set at the port where the drug outlet through hole is connected to the outside world.

[0082] Furthermore, the number and arrangement of the drug outlet channels and their internal buffer cavities and drug outlet holes can be diversified and designed. For example, multiple drug outlet channels can be arranged along the length of the sheath 3; the drug outlet channels can be distributed on both sides of the sheath 3; the number of buffer cavities 302 in each drug outlet channel can be multiple, and the multiple buffer cavities 302 are interconnected; and the drug outlet holes in each drug outlet channel can be arranged along the height of the sheath 3.

[0083] The side of the sheath 3 is provided with a plurality of drug outlet holes from top to bottom, which are connected to the buffer chamber 302. The drug outlet holes are located at different heights so that the drug is sprayed at different distances. Setting the drug outlet holes at different heights can allow the drug to cover the surface of the balloon body 1 as much as possible.

[0084] For example, the diameter of the balloon body 1 can be 1.0 mm to 40.0 mm, and the length can be 10 mm to 300 mm. The material of the balloon body 1 includes one or more of polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or a polymer material with good biocompatibility. It should be noted that the size and material of the balloon body 1 can be set by those skilled in the art as needed and are not limited to the size ranges and materials disclosed in the above embodiments.

[0085] The material of the scoring part 2 can also be medical stainless steel, cobalt-chromium alloy, nickel-titanium alloy or other metals or alloys with good biocompatibility, or a polymer material with good biocompatibility. In order to further improve the flexibility of the scoring balloon, the material of the scoring part 2 can be selected as nickel-titanium alloy, which has good shape memory properties.

[0086] In addition, embodiments of the present application also disclose a balloon catheter comprising a catheter hub, an inner tube, an outer tube, the drug-loaded scored balloon described in the aforementioned specific embodiments, and a terminal tube. The catheter hub is a hollow structure, equipped with a balloon inflation / decompression interface and a guidewire outlet. The inner tube is sheathed within the outer tube, the lumen of the inner tube serving as a guidewire lumen, which is connected to the guidewire outlet. During use, a guidewire enters the terminal tube and exits the body through the guidewire outlet.

[0087] The proximal end of the outer tube is connected to the catheter seat, and the distal end of the outer tube is provided with a balloon body 1. A balloon filling cavity is formed between the inner wall of the outer tube and the outer wall of the inner tube. The balloon filling and decompression interface is connected to the balloon through the balloon filling cavity, which is used to fill and expand or decompress and contract the balloon.

[0088] Obviously, the balloon catheter including the above-mentioned drug-loaded scored balloon has the same beneficial effects, which will not be described in detail here.

[0089] Compared with the existing method of forming a drug coating on the surface of the scored balloon in the prior art, the drug is lost more in the process of the balloon reaching the lesion and is easily carried away by the blood flow, which is not conducive to absorption by the required position of the blood vessel; the present solution provides a drug-loaded scored balloon and balloon catheter, by forming a drug storage cavity 301 in the scored member 2 or the sheath 3, and a drug outlet channel is formed in the sheath 3. When the sheath 3 is squeezed by the lesion, the scored member 2 extends from the sheath 3, and the drug storage space is reduced. Due to the squeezing, the drug is released to the surface of the balloon body 1 through the drug outlet channel; compared with the previous drug balloon, this design is During the process of transporting the balloon body 1 to the lesion site, normal vascular tissue does not come into contact with the drug, thereby avoiding the loss of the drug during the balloon delivery process. Only when the balloon body 1 reaches the lesion site and the balloon body 1 expands, the lesion site squeezes the sheath 3 to release the drug, which enables the drug to reach the lesion site in a quantitative or sufficient amount; at the same time, the design of the sheath 3 on the scoring part 2 enables the sheath 3 to protect the scoring part 2 during the process of transporting the drug-loaded scored balloon to the lesion and during the production process of the drug-loaded scored balloon to prevent the scoring part 2 from damaging normal tissue.

[0090] In the description of this application, the meaning of "plurality" is more than two. If there is a description of "first" or "second", it is only for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0091] As used in this application and the claims, unless the context clearly indicates an exception, the terms "a," "an," "an," and / or "the" are not intended to refer to the singular and may include the plural, unless the context clearly indicates otherwise. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements. The phrase "comprises a..." does not preclude the presence of additional identical elements in the process, method, product, or apparatus that includes the elements.

[0092] In the description of the embodiments of this application, unless otherwise specified, " / " represents or. For example, A / B can represent A or B. "And / or" in this article is simply a description of the association relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, in the description of the embodiments of this application, "plurality" means two or more than two.

[0093] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, and connecting should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0094] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0095] This document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core ideas of this application. It should be noted that for those skilled in the art, without departing from the principles of this application, various improvements and modifications can be made to this application, and such improvements and modifications also fall within the scope of protection of the claims of this application.

Claims

1. A drug-loaded scored balloon, characterized in that: include: Balloon body (1); A scoring member (2), the scoring member (2) being arranged on the outer wall of the balloon body (1) and arranged along an axial direction parallel to the balloon body (1); A sheath (3), wherein the bottom end of the sheath (3) is connected to the balloon body (1), and the top end is covered with the notched member (2). A first breaking line is arranged at a position where the top end of the sheath (3) is opposite to the notched member (2), and the first breaking line is used to break when the sheath (3) is squeezed. The inside of the sheath (3) is provided with a drug storage cavity (301) for storing drugs and a drug outlet channel for releasing drugs to the outside, and the two ends of the drug outlet channel are connected to the outside and the drug storage cavity (301) respectively. When the balloon body (1) reaches the lesion site and expands, the top end of the sheath (3) is squeezed by the inner wall of the blood vessel. As the space of the drug storage cavity (301) gradually decreases, the drug is discharged to the surface of the balloon body (1) through the drug storage cavity (301) and the drug outlet channel. At the same time, the first breaking line at the top end of the sheath (3) breaks, allowing the top end of the notched member (2) to protrude from the sheath (3).

2. The drug loaded scored balloon according to claim 1, characterized in that: The drug outlet channel is provided with a protective film at a port communicating with the outside, and the protective film is provided with a second breaking line, and the second breaking line is used to break when the sheath (3) is squeezed.

3. The drug loaded scored balloon according to claim 1, characterized in that: The protective sleeve (3) is provided with an installation cavity inside, a sliding seat (304) is provided at the bottom of the installation cavity, and a sliding groove member (201) that is slidably matched with the sliding seat (304) is provided at the bottom of the notch member (2); In an initial state, the notched member (2) is located at the top of the installation cavity, and the drug storage cavity (301) is formed between the slide groove member (201) of the notched member (2) and the slide seat (304) and / or between the slide seat (304) and the side wall of the installation cavity; when the balloon body (1) reaches the lesion position and expands, and the top end of the sheath (3) is squeezed by the inner wall of the blood vessel, the notched member (2) moves toward the slide seat (304), and the space of the drug storage cavity (301) gradually decreases.

4. The drug loaded scored balloon according to claim 3, characterized in that: The cross section of the slide seat (304) is T-shaped, the slide groove member (201) comprises two parallel flat plates and a limit plate arranged on the bottom side of the flat plate, the top of the flat plate is connected to the notch member (2), and the limit plate is used to abut against the top end of the slide seat (304) to achieve limiting.

5. The drug loaded scored balloon according to claim 3, characterized in that: It also includes a guide tube (303), which is arranged on the side of the sheath (3) and laid on the outer wall of the balloon body (1), one end of the guide tube (303) is connected to the drug outlet channel, and a plurality of through holes are opened on the side wall.

6. The drug loaded scored balloon according to claim 1, characterized in that: The interior of the sheath (3) is provided with an installation cavity, the bottom of the installation cavity is provided with the notched member (2), and the medicine storage cavity (301) is formed between the notched member (2) and the installation cavity of the sheath (3).

7. The drug loaded scored balloon according to claim 1, characterized in that: The sheath (3) is provided with an installation cavity inside, the installation cavity covers the notched member (2), and the medicine storage cavity (301) is provided on the side of the notched member (2).

8. The drug loaded scored balloon according to claim 1, characterized in that: The drug outlet channel comprises a buffer cavity (302) and a drug outlet through hole, and the two ends of the buffer cavity (302) are respectively connected to the drug storage cavity (301) and the drug outlet through hole. When the balloon body (1) reaches the lesion position and expands, the top end of the sheath (3) is squeezed by the inner wall of the blood vessel, and as the space of the drug storage cavity (301) gradually decreases, the drug is discharged to the surface of the balloon body (1) via the drug storage cavity (301), the buffer cavity (302) and the drug outlet through hole in sequence.

9. The drug loaded scored balloon according to claim 8, characterized in that: The drug outlet channels are multiple and arranged along the length direction of the sheath (3), and / or the drug outlet channels are distributed on both sides of the sheath (3), and / or the number of buffer cavities (302) in each of the drug outlet channels is multiple, and the multiple buffer cavities (302) are interconnected, and / or the drug outlet through holes in each of the drug outlet channels are multiple and arranged along the height direction of the sheath (3).

10. A balloon catheter, characterized in that: It comprises the drug-loaded scored balloon according to any one of claims 1-9.

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