Drug-carrying indented balloon and balloon catheter

Abstract

The present application discloses a drug-carrying indented balloon and a balloon catheter. By forming a drug storage chamber and a drug delivery channel in the sheath, the indentation element protrudes from the sheath when the sheath is compressed at the lesion site, and the space within the drug storage chamber gradually decreases. The pressure forces the drug through the drug storage chamber and drug delivery channel to the surface of the balloon body. Compared to previous drug balloons, this design prevents normal vascular tissue from coming into contact with the drug during transport of the drug-carrying indented balloon to the lesion site, thus avoiding drug loss during delivery.Only when the drug-carrying indentation balloon reaches the lesion site, and the balloon body expands, causing the lesion to compress the sheath, can the drug be released. This allows the drug to reach the lesion site in a specific or sufficient quantity. Simultaneously, the design of adding a sheath to the indentation element allows the sheath to protect the indentation element during delivery to the lesion site and during the balloon's inflation, preventing it from damaging the surrounding tissue.

Description

Cross-references to related applications

[0001] This application claims priority to the Chinese patent application filed with the Chinese Patent Office on April 26, 2024, with application number 202410508940.5 and invention titled “Drug-carrying notched balloon and balloon catheter,” the entire contents of which are incorporated by reference into this application. Technical area

[0002] The present application belongs to the technical field of medical devices and relates in particular to a drug-carrying notched balloon and a balloon catheter. Background technology

[0003] Clogged arteries in humans have become a major medical problem over the years. This is because clogged arteries lead to reduced blood flow to the arteries, resulting in a number of serious complications. Arterial narrowing is primarily due to deposits of cholesterol, calcium, and fibrotic tissue, and angioplasty is probably the most common treatment. Angioplasty uses an inflatable balloon to widen clogged arteries. However, this treatment option is associated with a high rate of restenosis.

[0004] To solve the problems described above, notch balloons have been developed that can transect stenosis during angioplasty to enhance the stenosis dilation effect. Some notch balloons also form a drug layer on the balloon surface to release therapeutic drugs at the lesion site. The drugs diffuse into the tissue of the diseased blood vessel wall, thus achieving a better effect in inhibiting intimal hyperplasia and treating lesions, thus achieving a better lumen expansion effect. In the existing method of forming a drug coating on the balloon surface with the notch balloon, the drug is lost and carried away by the bloodstream during balloon transport to the lesion site, resulting in the drug coming into contact with the normal vascular tissue and insufficient drug delivery to the lesion site.At the same time, the notching element can easily scratch the normal vascular tissue during transport to the lesion site.

[0005] Therefore, how to avoid the loss of the drug during the delivery of the drug-carrying notching balloon to the lesion site and, at the same time, how to prevent the scratching of the normal vascular tissue by the notching element during the delivery to the lesion site is an urgent problem that can be urgently solved by the professional staff. Contents of the invention

[0006] The purpose of the present application is to provide a drug-carrying notching balloon and a balloon catheter that prevent loss of the drug during delivery of the drug-carrying notching balloon to the lesion site and at the same time prevent scratching of the normal vascular tissue by the notching element during delivery to the lesion site.

[0007] To solve the technical problems described above, the present application provides a drug-carrying notch balloon comprising: a balloon body; a notch element, wherein the notch element is provided on the outer wall of the balloon body and is arranged along an axial direction parallel to the balloon body; a sleeve, the lower end of the sleeve being connected to the balloon body and the upper end of the sleeve being covered with the notch element, the upper end of the sleeve being provided with a first fracture line at the position opposite the notch element, the first fracture line being designed to break when the sleeve is compressed, and the inner part of the sleeve being provided with a medicine storage chamber for storing medicines and a medicine delivery channel for delivering medicines to the outside world, the two ends of the medicine delivery channel being connected to the outside world and the medicine storage chamber, respectively; When the balloon body reaches the lesion site and expands, and the upper end of the sheath is compressed by the inner wall of the blood vessel, the drug is delivered to the surface of the balloon body via the drug storage chamber and the drug delivery channel, while the space of the drug storage chamber gradually decreases, and at the same time, the first fracture line at the upper end of the sheath is broken, so that the tip of the notch member protrudes from the inside of the sheath.

[0008] Optionally, the drug delivery channel in the drug-carrying notched balloon described above is provided with a protective film at an opening connected to the outside world, wherein the protective film is provided with a second fracture line configured to break when the sheath is compressed.

[0009] Optionally, in the drug-carrying notched balloon described above, the inner part of the sheath is provided with a mounting cavity, wherein a sliding block is provided at the bottom of the mounting cavity, and a sliding groove member is provided at the bottom of the notch member, which is in sliding fit with the sliding block; In the initial state, the notch element is located at the top of the fixing cavity, and the drug storage chamber is formed between the sliding groove element of the notch element and the sliding block and / or between the sliding block and the side wall of the fixing cavity; when the balloon body reaches the lesion site and expands, and the upper end of the sleeve is compressed by the inner wall of the blood vessel, the notch element moves toward the sliding block, and the space of the drug storage chamber gradually decreases.

[0010] Optionally, in the drug-carrying notch balloon described above, the cross-section of the sliding block is T-shaped, the sliding groove member comprises two parallel arranged flat plates and a limiting plate arranged on the underside of the flat plates, wherein the top of the flat plates is connected to the notch member and the limiting plate is configured to abut against the top of the sliding block to achieve a limit.

[0011] Optionally, the drug-carrying notched balloon further comprises a guide catheter, wherein the guide catheter is provided on the side of the sheath and laid on the outer side wall of the balloon body, wherein one end of the guide catheter is connected to the drug delivery channel, and a plurality of through holes are provided on the side wall of the guide catheter.

[0012] Optionally, in the above-described drug-carrying notched balloon, the inner part of the sheath is provided with an attachment cavity, wherein the notch element is provided at the bottom within the attachment cavity, and the drug storage chamber is formed between the notch element and the attachment cavity of the sheath.

[0013] Optionally, in the drug-carrying notch balloon described above, the inner part of the sheath is provided with an attachment cavity, wherein the attachment cavity encloses the notch element, and the drug storage chamber is provided on the side of the notch element.

[0014] Optionally, in the drug-carrying notched balloon described above, the drug delivery channel includes a buffer chamber and a drug delivery through-hole, and the two ends of the buffer chamber are respectively connected to the drug storage chamber and the drug delivery through-hole, so that when the balloon body arrives at the lesion site and expands and the upper end of the sheath is compressed by the inner wall of the blood vessel, the drug is sequentially discharged to the surface of the balloon body through the drug storage chamber, the buffer chamber, and the drug delivery through-hole with the gradual narrowing of the space for the drug storage chamber.

[0015] Optionally, in the above-described drug-carrying notched balloon, the drug delivery channels are provided in multiples along the longitudinal direction of the sheath, and / or the drug delivery channels are distributed on both sides of the sheath, and / or the buffer chambers are provided in multiples in each of the drug delivery channels, the plurality of buffer chambers being connected to each other, and / or the drug delivery through-holes are provided in multiples in each of the drug delivery channels in the height direction of the sheath.

[0016] The present application also provides a balloon catheter comprising the drug-carrying notched balloon described above.

[0017] The present application provides a drug-carrying indentation balloon whose beneficial effect is: By forming a drug storage chamber and a drug delivery channel in the sleeve, when the sleeve is compressed by the lesion site, the notch element protrudes from the sleeve, and the space of the drug storage chamber gradually decreases. Under pressure, the drug is delivered to the surface of the balloon body through the drug storage chamber and drug delivery channel. Compared with previous drug balloons, this design prevents normal vascular tissue from coming into contact with the drug during the transport of the drug-carrying notch balloon to the lesion site, thereby avoiding the loss of the drug during the delivery of the drug-carrying notch balloon. Only when the drug-carrying notch balloon reaches the lesion site and the balloon body expands, and the lesion site compresses the sleeve, can the drug be released.This allows the drug to reach the lesion site in a certain or sufficient amount; at the same time, the design of adding a sheath on the notching element enables the sheath to protect the notching element during the delivery of the drug-carrying notching balloon to the lesion site and during the production of the drug-carrying notching balloon, preventing the notching element from injuring the normal tissue.

[0018] The present application also provides a balloon catheter having the drug-carrying notched balloon described above, which has the same beneficial effects and is not further described here. Figures

[0019] In order to more clearly illustrate the technical solutions in the specific embodiments of the present application or the prior art, the accompanying drawings are briefly presented below. These drawings must be used in describing the specific embodiments or the prior art. It is obvious that the accompanying drawings in the following description represent some of the embodiments of the present application, and that general technical personnel in the field, provided they do not perform creative work, can obtain other drawings based on the accompanying drawings. Fig. 1 shows a schematic representation of the structure of a drug-carrying notch balloon according to Embodiment 1 of the present application; Fig. 2 shows a main view of a drug-carrying notch balloon according to Embodiment 1 of the present application; Fig. 3 shows a drug-carrying notch balloon of a cross section of a drug-carrying notch balloon according to Embodiment 1 of the present application before deformation; Fig. 4 shows a partially enlarged view of Fig. 3 at A; Fig. 5 shows a schematic representation of a cross section of a drug-carrying notch balloon according to Embodiment 1 of the present application after deformation; Fig. 6 shows a partially enlarged view of Fig. 5 at B; Fig. 7 shows a schematic representation of a cross section of a shell according to Embodiment 1 of the present application; Fig. 8 shows a main view of the notch member according to Embodiment 1 of the present application; Fig. Figure 9 shows a schematic representation of a cross section of Fig. 8 in direction AA; Fig. 10 is a schematic diagram showing the structure of a drug-carrying notch balloon according to Embodiment 2 of the present application; Fig. 11 shows a main view of a drug-carrying notch balloon according to Embodiment 2 of the present application; Fig. 12 shows a schematic representation of a cross-section of a drug-carrying notch balloon according to Embodiment 2 of the present application before deformation; Fig. 13 shows a partially enlarged view of Fig. 12 at C; Fig. 14 shows a schematic cross-sectional view of a drug-carrying notch balloon according to Embodiment 2 of the present application after deformation; Fig. 15 shows a partially enlarged view of Fig. 14 at D; Fig. 16 shows a schematic representation of the structure of a drug-carrying notch balloon according to Embodiment 3 of the present application; Fig. 17 shows a main view of a drug-carrying notch balloon according to Embodiment 3 of the present application; Fig. 18 shows a schematic cross-sectional view of a drug-carrying notch balloon according to Embodiment 3 of the present application before deformation; Fig. 19 shows a partially enlarged view of Fig. 18 at E; Fig. 20 shows a schematic cross-sectional view of a drug-carrying notch balloon according to Embodiment 3 of the present application after deformation; Fig. 21 shows a partially enlarged view of Fig. 20 at F; Fig. 22 shows a schematic representation of the structure of a drug-carrying notch balloon according to Embodiment 4 of the present application after deformation; Fig. 23 shows a main view of a drug-carrying notch balloon provided in Embodiment 4 of the present application; Fig. 24 shows a schematic cross-sectional view of a drug-carrying notch balloon according to Embodiment 4 of the present application before deformation; Fig. 25 shows a partially enlarged view of Fig. 24 at G; Fig. 26 shows a schematic representation of a cross section of a drug-carrying notch balloon according to Embodiment 4 of the present application after deformation; Fig. 27 shows a partially enlarged view of Fig. 26 at H.

[0020] In the figures: 1- Balloon body; 2- Notch element; 201- Sliding groove element; 3-Sheath; 301- Drug storage chamber; 302-Buffer chamber; 303-Guide catheter; 304-Sliding block. Specific embodiments

[0021] The exemplary embodiments of the present application are described in detail below. Examples of the exemplary embodiments are illustrated in the accompanying drawings, wherein identical or similar reference numerals throughout represent identical or similar elements or elements with identical or similar functions. The exemplary embodiments described below with reference to the drawings are exemplary and serve merely to explain the present application and should not be construed as limiting the present application.

[0022] In the description of the present application, it should be understood that the terms "proximal" and "distal" as used in this document refer to the near and far ends relative to the operator. When using 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 far from the physician or operator is the "distal end," i.e., the end where the balloon is located. These terms are intended to facilitate and simplify the description of the present application, rather than to indicate or imply that the device or component mentioned must have a particular orientation, be constructed, and operate in a particular orientation. Therefore, they should not be construed as limiting the present application.

[0023] The essence of this application is to provide a drug-carrying notching balloon and a balloon catheter that prevent loss of the drug during delivery of the drug-carrying notching balloon to the lesion site and at the same time prevent scratching of the normal vascular tissue by the notching element during delivery to the lesion site.

[0024] In order to enable those skilled in the art to better understand the technical solutions provided by the present application, this application is described in more detail below in conjunction with the attached drawings and specific embodiments.

[0025] In particular, with reference to the Fig. 1 to 27, the drug-carrying notching balloon disclosed in the present application comprises: a balloon body 1, a notching element 2 and a sheath 3. The notch element 2 is provided on the outer wall of the balloon body 1 and arranged along an axial direction parallel to the balloon body 1. It should be noted that the placement of the notch element 2 on the outer wall of the balloon body 1 refers not only to the attachment of the notch element 2 to the outer wall of the balloon body 1, but also to the spatial relationship between the two, and is not a fixed relationship. That is, the notch element 2 is arranged on the outer wall of the balloon body 1, and it is understood that the notch element 2 is located on the outside of the balloon body 1.In particular, the notch element 2 can be attached directly to the outer wall of the balloon body 1 or provided indirectly via other components on the outer wall of the balloon body 1, for example, the notch element 2 can be provided on the sleeve 3 and by arranging the sleeve 3 on the outer wall of the balloon body 1, the same effect as by arranging the notch element 2 on the outer wall of the balloon body 1 can be achieved.

[0026] The balloon body 1 may have a structure with a central cylinder and two tapered ends. The central cylindrical structure is the working section, and the tapered ends are the non-working section. A development ring is provided on the outer surface of the inner tube corresponding to the balloon body 1, and the balloon body 1 can be positioned at the lesion site by the development ring.

[0027] The notch element 2 can be provided at the central cylindrical portion of the balloon body 1, arranged along the axial direction parallel to the balloon body 1, and fixed with an adhesive. Note that in the solution in which the notched part 2 is movable, the notched part 2 does not need to be fixed with an adhesive.

[0028] The number of notch elements 2 is n, and n is an integer greater than or equal to 1. If the notch elements 2 are present in multiples, they can be evenly arranged in the circumferential direction on the outer surface of the balloon body 1. The angle between two adjacent notch elements 2 along the circumferential direction is 360° / n. Optionally, the number of notch elements 2 is three, which means that the angle between two adjacent notch elements 2 along the circumferential direction is 120°.

[0029] If multiple notching elements 2 are present, the sleeves 3 are also present in multiples and correspond one-to-one to the notching elements 2. The lower end of the sleeve 3 is connected to the balloon body 1, and the upper end is covered with a notching element 2. This means that in the initial state, the notching element 2 is covered by the sleeve 3, so that the entire notching element 2, in particular the blade of the notching element 2, is not exposed.

[0030] The upper end of the sheath 3 is provided with a first fracture line at the position opposite the notch element 2. The first fracture line is designed to break when the sheath is compressed. Normally, the blade portion of the notch element 2 is located on the side of the notch element 2 facing away from the balloon body 1. To ensure that the sheath 3 can reliably break upon compression, the first fracture line may be arranged at a position corresponding to the blade of the notch element 2. When the sheath 3 is compressed, the blade of the notch element 2 can cut off the first fracture line and assist in breaking the first fracture line.The inner part of the shell 3 is provided with a medicine storage chamber 301 for storing medicine and a medicine delivery channel for delivering medicine to the outside world. The two ends of the medicine delivery channel are connected to the outside world and the medicine storage chamber 301, respectively. Therefore, when the space of the medicine storage chamber 301 decreases or the pressure increases, the medicine stored in the medicine storage chamber 301 can be delivered to the outside through the medicine delivery channel. Note that the medicine can be injected from the end of the shell 3 and then sealed. The medicine is sealed in the medicine storage chamber 301 and can only be pushed out through the medicine delivery channels on both sides of the shell 3.

[0031] When the balloon body 1 reaches the lesion site and expands, the upper end of the sleeve 3 is compressed by the inner wall of the blood vessel, causing the upper end of the sleeve 3 to move toward the balloon body 1, and the space of the drug storage chamber 301 to gradually decrease. As the space for the drug storage chamber 301 gradually narrows, the drug is discharged through the drug delivery channel to the surface of the balloon body 1. At the same time, the first fracture line at the upper end of the sleeve 3 is broken, so that the tip of the notching element 2 (at least the blade of the notching element 2) protrudes from the interior of the sleeve 3.

[0032] It should be noted that the purpose of setting the first fracture line on the sheath 3 is that when the balloon body 1 does not reach the intended position, the sheath 3 covers the entire notch element 2, so that the notch element 2 is prevented from contacting the vascular tissue, thereby preventing the notch 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 upper end of the sheath 3 is compressed by the inner wall of the blood vessel, the first fracture line can be broken, so that the notch element 2 is exposed from the sheath 3.In particular, the first fracture line is arranged in a direction parallel to the axis of the balloon body 1, that is, after the shell 3 is fractured along the direction of the first fracture line, the shell 3 is divided into two halves, thereby exposing the internal notch element 2 located in the inner part.

[0033] The drug-carrying notch balloon disclosed by the embodiment of the present application forms a drug storage chamber 301 and a drug delivery channel in the sheath 3. The notch element 2 protrudes from the sheath 3 when the sheath 3 is compressed by the lesion site, and the space of the drug storage chamber 301 gradually decreases. Under pressure, the drug is delivered to the surface of the balloon body 1 through the drug storage chamber 301 and the drug delivery channel. With this construction, the drug-carrying notch balloon is delivered to the lesion site without contacting the normal vascular tissue with the drug, compared to previous drug balloons, thereby preventing the loss of the drug during delivery of the drug-carrying notch balloon.Only when the drug-carrying notch balloon reaches the lesion site, the balloon body 1 expands, and the lesion site compresses the sheath 3 to release the drug, allowing the drug to reach the lesion site in a certain or sufficient amount; At the same time, the design of adding a sheath 3 to the notch member 2 allows the sheath 3 to protect the notch member 2 during the delivery of the drug-carrying notch balloon to the lesion site and during the manufacturing of the drug-carrying notch balloon, preventing the notch member 2 from damaging normal tissue.

[0034] It should be noted that the drug delivery channel can be a smaller diameter hole, that is, the hole diameter on the outlet side of the drug delivery channel should be able to satisfy the surface tension for blocking. When the drug is liquid, surface tension naturally forms on the outlet-side surface of the drug delivery channel. If the shell 3 is not compressed, the drug will not flow out of the drug delivery channel under the action of surface tension.

[0035] If the drug delivery channel is a hole with a larger diameter, the surface tension created is insufficient to seal the drug in the drug storage chamber 301 without leakage. Based on this, in a specific embodiment, the drug delivery channel is provided with a protective film at the opening connected to the outside world. This ensures that the drug does not flow out of the drug delivery channel in its natural state. Only when the sleeve 3 is compressed can the drug flow out of the drug delivery channel.

[0036] To ensure that the medication can reliably flow out of the medication delivery channel when the sleeve 3 is compressed, a second break line is provided on the protective film. When the sleeve 3 is compressed, the space of the medication storage chamber 301 is narrowed, and the medication compresses the protective film, causing the second break line to break.

[0037] The working principle of the second fault line is similar to the working principle of the first fault line, and the second fault lines can exist multiple times.

[0038] There are many ways of arranging the notch element 2 within the shell 3. In a specific embodiment, the inner part of the shell 3 is provided with a mounting cavity, wherein at the bottom of the mounting cavity a sliding block 304 (as in Fig. 7, the bottom of the fixing cavity is provided on a side of the fixing cavity which is close to the balloon body 1, and a sliding groove member 201 which is in sliding fit with the sliding block 304 is provided on the bottom of the notch member 2.

[0039] In the initial state, the notch member 2 is located at the top of the mounting cavity. Specifically, the notch member 2 can be held by the constraint of the sheath 3 at the top of the mounting cavity. A medicine storage chamber 301 is formed between the sliding groove member 201 of the notch member 2 and the sliding block 304 and / or between the sliding block 304 and the side wall of the mounting cavity for storing medicines. Since the notch member 2 is located at the top of the installation cavity, there is a large space between the sliding groove member 201 and the sliding block 304, which can accommodate medicines. There is also a certain space between the sliding block 304 and the side wall of the installation cavity, which can store medicines.

[0040] When the balloon body 1 reaches the lesion site and expands, and the upper end of the sheath 3 is compressed by the inner wall of the blood vessel, the notch member 2 moves toward the sliding block 304 under the guidance of the sliding groove member 201 (since the sliding block 304 is located on the attachment cavity side near the balloon body 1, the notch member 2 moves toward the installation cavity side near the balloon body 1 under the guidance of the sliding groove member 201), and the space of the drug storage chamber 301 gradually decreases. That is, the notch member 2 moves toward the balloon body 1 under the action of the sliding fit between the sliding groove member 201 and the sliding block 304, so that the space between the sliding groove member 201 and the sliding block 304 gradually decreases.At the same time, the sliding groove member 201 gradually occupies the space between the sliding block 304 and the side wall of the installation cavity, so that the space volume here also gradually decreases, whereby the space of the medicine storage chamber 301 gradually decreases with the movement of the notch member 2.

[0041] As in the Fig. 7 to 9, the cross section of the sliding block 304 is T-shaped.

[0042] The sliding groove member 201 includes two parallel flat plates and a limiting plate arranged on the underside of the flat plates (i.e., the side 1 facing the balloon body). The upper side of the flat plates is connected to the notch member 2, and the limiting plate is configured to abut against the upper side of the sliding block 304 to limit the up-and-down movement of the notch member 2 and prevent the notch member 2 from falling off.

[0043] As in the Fig. 18 to 21, in another specific embodiment, the inner part of the shell 3 is provided with a fastening cavity, the notch member 2 being provided at the bottom within the fastening cavity, and the medicament storage chamber 301 being formed between the notch member 2 and the fastening cavity of the shell 3.

[0044] As in the Fig. 24 to 27, in another specific embodiment, the inner part of the shell 3 is provided with a fastening cavity, the fastening cavity enclosing the notch element 2, and the medicament storage chamber 301 is provided on the side of the notch element 2.

[0045] As in the Fig.As shown in Figures 12 to 15, the present solution further comprises a guide catheter 303. The guide catheter 303 is provided on the side of the sheath 3 and is laid on the outer side wall of the balloon body 1. One end of the guide catheter 303 is connected to the drug delivery channel, and a plurality of through holes are provided on the side wall of the guide catheter 303. There are a plurality of guide tubes 303 that correspond one-to-one to the drug delivery channels. The guide catheter 303 has a plurality of through holes on both side walls. When the balloon body 1 expands and the upper end of the sheath 3 is compressed by the inner wall of the blood vessel, the space of the drug storage chamber 301 narrows, and the drug is delivered through the surface of the balloon body 1 via the drug storage chamber 301—the drug delivery channel—the guide catheter 303.

[0046] To prevent the sheath 3 from being easily squeezed and the internal drug from splashing out, the drug delivery channel includes a buffer chamber 302 and a drug delivery through-hole. The two ends of the buffer chamber 302 are respectively connected to the drug storage chamber 301 and the drug delivery through-hole. Specifically, the buffer chamber 302 and the drug storage chamber 301 may be connected through several small holes. When the balloon body 1 arrives at the lesion site and expands, and the upper end of the sheath 3 is compressed by the inner wall of the blood vessel, with the gradual narrowing of the space for the drug storage chamber 301, the drug is sequentially discharged to the surface of the balloon body 1 through the drug storage chamber 301, the buffer chamber 302, and the drug delivery through-hole.In the initial state, there is no drug in the buffer chamber 302 and the drug delivery through-hole, and the buffer chamber 302 is part of the drug delivery channel. The above-mentioned protective film and the second break line are arranged at the opening where the drug delivery through-hole connects to the outside world.

[0047] Furthermore, the number and arrangement of the drug delivery channel and its internal buffer chambers, as well as the drug delivery through-holes, can be designed in various combinations. For example, there are multiple drug delivery channels arranged along the longitudinal direction of the shell 3; the drug delivery channels are distributed on both sides of the shell 3; each drug delivery channel has multiple buffer chambers 302, and the multiple buffer chambers 302 are connected to each other; each drug delivery channel has multiple drug delivery through-holes arranged along the height direction of the shell 3.

[0048] Several drug delivery holes are opened from top to bottom on the side of the sleeve 3. The drug delivery holes are connected to the buffer chamber 302. The drug delivery holes are arranged at different heights, allowing the drug to eject at different distances. By arranging the drug delivery holes at different heights, the drug can cover the surface of the balloon body 1 as much as possible.

[0049] 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 polyvinyl chloride, polyethylene, polyurethane, polyamide, polyether block polyamide, polyethylene terephthalate, or one of the polymer materials with good biocompatibility or more. It should be noted that the dimension and material of the balloon body 1 can be adjusted by the skilled person as needed and are not limited to the dimension range and material disclosed in the above embodiments.

[0050] The material of the notching element 2 can also be medical-grade stainless steel, cobalt-chromium alloy, nickel-titanium alloy, or other metals or alloys with good biocompatibility, or it can also be polymer materials with good biocompatibility. To further improve the flexibility of the notching balloon, the optional notching element 2 is made of a nickel-titanium alloy with good shape memory.

[0051] Furthermore, embodiments of the present application also disclose a balloon catheter comprising a catheter hub, an inner tube, an outer tube, the drug-carrying notched balloon in the above-mentioned specific embodiments, and an end tube. Among them, the catheter hub is a hollow structure, and the catheter hub is provided with a balloon inflation and decompression interface and a guidewire outlet. The inner tube is inserted into the outer tube, and the inner lumen of the inner tube is the guidewire lumen, and the guidewire lumen is connected to the guidewire outlet. During use, the guidewire enters the end tube and is guided out of the body through the guidewire outlet.

[0052] The proximal end of the outer tube is connected to the catheter hub, and the distal end of the outer tube is provided with a balloon body 1. A balloon inflation cavity is formed between the inner wall of the outer tube and the outer wall of the inner tube. The balloon inflation and decompression interface is connected to the balloon via the balloon inflation cavity and is designed to inflate and expand the balloon or to depressurize it.

[0053] Obviously, the balloon catheter containing the drug-carrying notched balloon mentioned above has the same beneficial effects, which are not described in detail here.

[0054] Compared with the prior art, in which the notch balloon forms a drug coating on the surface of the balloon. The drug is lost more during the process of the balloon reaching the lesion, is easily carried away by the bloodstream, and is not well absorbed by the blood vessels where it is needed; the solution provides a drug-carrying notch balloon, wherein a drug delivery channel is formed by the formation of the drug storage chamber 301 in the notch element 2 or the sheath 3 in the sheath 3. The notch element 2 protrudes from the sheath 3 when the sheath 3 is compressed by the lesion site, and the drug storage space gradually decreases.Due to the pressure, the drug is delivered through the drug delivery channel to the surface of the balloon body 1; With this design, compared with previous drug balloons, the drug-carrying notch balloon is transported to the lesion site without the normal vascular tissue coming into contact with the drug, thus avoiding the loss of the drug during the delivery of the drug-carrying notch balloon.Only when the balloon body 1 reaches the lesion site, the balloon body 1 expands, and the lesion site compresses the sheath 3 to release the drug, allowing the drug to reach the lesion site in a certain or sufficient amount; At the same time, the design of adding a sheath 3 to the notch member 2 allows the sheath 3 to protect the notch member 2 during the delivery of the drug-carrying notch balloon to the lesion site and during the manufacturing of the drug-carrying notch balloon 2, and prevents the notch member 2 from damaging normal tissue.

[0055] In the description of this application, the plural means two or more. The terms "first" and "second" serve only to distinguish technical features and should not be understood to indicate or imply the relative importance, or to imply the number of technical features specified, or to imply the order of the technical features specified.

[0056] As shown in this application and the claims, terms such as "a," "a piece," "a kind," and / or "the" do not specifically refer to the singular and may include the plural unless the context clearly indicates an exception. Generally, the terms "comprising" and "including" imply only the inclusion of clearly identified steps and elements. However, these steps and elements do not constitute an exclusive list, method, or device and may include other steps or elements. An element limited by the statement "comprising a..." does not preclude the presence of other identical elements in the process, method, article, or device incorporating the element.

[0057] In the description of the embodiments of the present application, " / " means "or" unless otherwise specified. For example, A can mean A / B or B. "And / or" here merely describes the association relationship of the related objects and indicates that three relationships can exist. For example, A and / or B can mean A alone, both A and B, and B alone. Furthermore, "more than one" in the description of the embodiments of the present application means two or more than two.

[0058] In the description of the present application, unless expressly stated otherwise, the terms such as arrangement, installation, connection, etc. are to be understood in the broadest sense, and the technicians in the field of technology can appropriately determine the specific meaning of the above terms in this application in conjunction with the specific content of the technical solutions.

[0059] Each embodiment in this specification is described step by step, and each embodiment focuses on the differences from other embodiments, and the same and similar parts of each embodiment can be related to each other.

[0060] This document illustrates the principles and methods of implementation of this application using specific examples. The description of the above embodiments serves only to facilitate understanding of the method and its core idea of ​​the present application. It should be noted that various improvements and modifications to the present application can be made by those skilled in the art without departing from the principles of the present application. These improvements and modifications also fall within the scope of the claims of the present application.

Claims

[1] Drug-carrying indentation balloon, characterized by that it includes: a balloon body (1); a notch element (2), wherein the notch element (2) is provided on the outer wall of the balloon body (1) and is arranged along an axial direction parallel to the balloon body (1); a sheath (3), the lower end of the sheath (3) being connected to the balloon body (1) and the upper end of the sheath (3) being covered with the notch element (2), the upper end of the sheath (3) being provided with a first break line at the location opposite the notch element (2), wherein the first fracture line is designed to break when the shell (3) is compressed, and wherein the inner part of the shell (3) is provided with a medicament storage chamber (301) for storing medicaments and a drug delivery channel for delivering drugs to the outside world, wherein the two ends of the drug delivery channel are respectively connected to the outside world and the drug storage chamber (301); when the balloon body (1) reaches the lesion site and expands and the upper end of the sheath (3) is compressed by the inner wall of the blood vessel, the drug is delivered to the surface of the balloon body (1) via the drug storage chamber (301) and the drug delivery channel, while the space of the drug storage chamber (301) gradually decreases, and at the same time, the first fracture line at the upper end of the sheath (3) is broken so that the tip of the notch member (2) protrudes from the inside of the sheath (3). [2] Drug-carrying notch balloon according to claim 1, characterized bythat the drug delivery channel is provided with a protective film at an opening connected to the outside world, wherein the protective film is provided with a second fracture line which is designed to break when the shell (3) is compressed. [3] Drug-carrying notch balloon according to claim 1, characterized bythat the inner part of the shell (3) is provided with a fastening cavity, wherein a sliding block (304) is provided at the bottom of the fastening cavity, and a sliding groove element (201) is provided at the bottom of the notch element (2) which is in sliding engagement with the sliding block (304); that the notch element (2) is located at the top of the fastening cavity in the initial state, and the medicine storage chamber (301) is formed between the sliding groove element (201) of the notch element (2) and the sliding block (304) and / or between the sliding block (304) and the side wall of the fastening cavity; that when the balloon body (1) reaches the lesion site and expands and the upper end of the sheath (3) is compressed by the inner wall of the blood vessel, the notch member (2) moves to the sliding block (304) and the space of the drug storage chamber gradually decreases. [4] Drug-carrying notch balloon according to claim 3, characterized by in that the cross section of the sliding block (304) is T-shaped, the sliding groove element (201) comprises two parallel arranged flat plates and a limiting plate arranged on the underside of the flat plates, wherein the upper side of the flat plates is connected to the notch element (2) and the limiting plate is designed to bear against the upper side of the sliding block (304) in order to achieve a limit. [5] Drug-carrying notch balloon according to claim 3, characterized by that it further comprises a guide catheter (303), wherein the guide catheter (303) is provided on the side of the sheath (3) and is laid on the outer side wall of the balloon body (1), wherein one end of the guide catheter (303) is connected to the drug delivery channel and a plurality of through holes are provided on the side wall of the guide catheter (303). [6] Drug-carrying notch balloon according to claim 1, characterized by in that the inner part of the shell (3) is provided with a fastening cavity, wherein the notch element (2) is provided at the bottom within the fastening cavity and the medicament storage chamber (301) is formed between the notch element (2) and the fastening cavity of the shell (3). [7] Drug-carrying notch balloon according to claim 1, characterized by that the inner part of the shell (3) is provided with a fastening cavity, wherein the fastening cavity encloses the notch element (2), and the medicament storage chamber (301) is provided on the side of the notch element (2). [8] Drug-carrying notch balloon according to claim 3, characterized byin that the drug delivery channel comprises a buffer chamber (302) and a drug delivery through-hole, and the two ends of the buffer chamber (302) are respectively connected to the drug storage chamber (301) and the drug delivery through-hole, so that when the balloon body (1) arrives at the lesion site and expands and the upper end of the sheath (3) is compressed by the inner wall of the blood vessel, the drug is discharged to the surface of the balloon body (1) through the drug storage chamber (301), the buffer chamber (302) and the drug delivery through-hole in succession with the gradual narrowing of the space for the drug storage chamber (301). [9] Drug-carrying notch balloon according to claim 8, characterized bythat the drug outlet channels are provided in multiples along the longitudinal direction of the shell (3), and / or the drug outlet channels are distributed on both sides of the shell (3), and / or the buffer chambers (302) are provided in multiples in each of the drug delivery channels, wherein the plurality of buffer chambers (302) are connected to one another, and / or the drug delivery through-holes are provided in multiples in each of the drug delivery channels in the height direction of the shell (3). [10] Balloon catheter, characterized by that it comprises a drug-carrying notch balloon according to any one of claims 1-9.

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