Scoring balloon and scoring balloon dilation catheter

Abstract

The present application relates to the technical field of medical devices, and discloses a score balloon and a score balloon dilatation catheter, which comprise a balloon body and a plurality of score members. The plurality of score members are arranged on the outer wall of the balloon body and are spaced apart along the axial direction parallel to the balloon body, and the score members at least comprise a tapered tip. When the balloon body is in a contracted state, the outer wall of the balloon body forms adjacent recessed portions and protruding portions, the recessed portions and the protruding portions both extend along the axial direction parallel to the balloon body, the score members are located in the recessed portions, and the tapered tip does not protrude from the protruding portions. The independent arrangement of the plurality of score members can reduce the constraint of the score members on the deformation of the balloon body, the score balloon can more smoothly pass through a tortuous lesion, the bending of the balloon body or the displacement of the score members can be avoided when the balloon body is inflated, the calcified lesion can be more efficiently dilated, and the operation difficulty is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a scoring balloon and a scoring balloon dilation catheter. Background Technology

[0002] Common treatments for vascular stenosis include medication, surgery, and endovascular treatment. Endovascular treatment includes balloon angioplasty, also known as percutaneous transluminal angioplasty. Balloon angioplasty is an interventional treatment method that involves inserting a balloon dilator along a guidewire path to the target lesion site in the artery, and using the expansion force generated by the balloon after inflation to dilate the narrowed artery.

[0003] For stenotic lesions such as calcification, plaque, or fibrosis, ordinary balloon catheters cannot effectively dilate the stenotic lesion and are prone to flow-limiting dissection. Therefore, a notched balloon is usually used instead of an ordinary balloon for dilation. A notched balloon has one or more notched wires fixed to the outer wall of the balloon. The cross-sectional shape of the notched wires is circular, rectangular, or triangular. During balloon inflation, the notched wires create a stress concentration effect in the contact area with the inner surface of the blood vessel, which can dilate calcified plaques. However, in actual operation, the notched wires have poor flexibility, making it difficult for the notched balloon to pass through tortuous lesions. Moreover, during balloon inflation, the balloon body will exhibit axial elongation. Since the notched wires are fixedly connected to the outer wall of the balloon and the length of the notched wires is fixed, the notched wires will restrict the normal expansion of the balloon body, which can easily lead to balloon bending and notched wire displacement, increasing the difficulty of dilating the lesion area. Summary of the Invention

[0004] This invention provides a notched balloon and a notched balloon dilation catheter to improve the flexibility of the notched balloon, ensure that the notched balloon can pass smoothly through tortuous lesions, and reduce the constraint of the notched part on the expansion and deformation of the balloon body, avoid balloon bending and displacement of the notched part, and reduce the difficulty of dilating the lesion area.

[0005] In a first aspect, the present invention provides a notched balloon, comprising: balloon body; Multiple scoring elements are disposed on the outer wall of the balloon body and are spaced apart along an axial direction parallel to the balloon body. Each scoring element includes at least a conical tip. When the balloon body is in a contracted state, the outer wall of the balloon body forms adjacent grooves and protrusions. Both the grooves and protrusions extend in a direction parallel to the axial direction of the balloon body. The scoring element is located in the groove, and the conical tip does not protrude from the protrusion.

[0006] Beneficial effects: By placing multiple independent scoring elements spaced apart on the outer wall of the balloon body, the deformation of the balloon body due to the scoring elements can be greatly reduced. Specifically, during balloon delivery, the balloon body is in a contracted state, and the multiple independent scoring elements are accommodated within the grooves, with their conical tips not protruding from the protrusions. When the balloon body adapts to the curvature of the blood vessel, there is no interaction force between the multiple scoring elements, allowing the balloon body to maintain its flexibility and smoothly pass through tortuous lesions. At the same time, it also ensures that the scoring elements will not damage normal blood vessels during balloon delivery. The inner wall significantly improves the permeability and safety of the notched balloon. During the balloon's expansion, even as the balloon body elongates axially, the outer wall of the balloon body can expand freely according to the predetermined shape because each notched component is relatively independent and there is no interaction force between them. This avoids bending of the outer wall of the balloon body due to tension, and also avoids displacement of the notched components due to bending of the outer wall of the balloon body. This ensures that multiple notched components are pressed into the calcified lesion according to the predetermined position, reducing the difficulty of expanding the calcified lesion.

[0007] Furthermore, since multiple scoring elements are spaced apart along an axial direction parallel to the balloon body, the conical tips of these elements can act on the same straight line. As the balloon body expands, the conical tips can be pressed into the calcified lesions within the blood vessel and generate cracks. Each scoring element will generate cracks after being pressed in, and the cracks between two adjacent scoring elements can easily connect and form gaps. The gaps generated by multiple scoring elements become a whole, thereby expanding the calcified lesions and effectively dilating them. Moreover, compared to scoring wires in related technologies, the conical tips provided by this invention have a smaller contact area with the calcified lesions, making the puncture ability of the conical tips stronger and easier to be pressed into the calcified lesions. Therefore, the balloon internal pressure required for the conical tips is lower than that required for scoring wires, making the scoring elements more efficient in expanding the calcified lesions and reducing the difficulty of operation.

[0008] Therefore, the notched balloon provided by the present invention can pass through tortuous lesions more smoothly, avoid the situation of the balloon body bending or the notched part shifting when the balloon body is inflated, and can expand calcified lesions more efficiently, reducing the difficulty of operation.

[0009] In one alternative embodiment, multiple scoring elements distributed along the same straight line are defined as a group along an axial direction parallel to the balloon body, and the multiple groups of scoring elements are distributed at uniform intervals along the circumference of the balloon body.

[0010] Beneficial effects: As the balloon inflates, multiple sets of notched elements can be pressed into the calcified lesion simultaneously, expanding multiple areas on the calcified lesion corresponding to the notched elements, thus improving the expansion efficiency of the calcified lesion. Furthermore, this design ensures that the outer wall of the balloon body is subjected to uniform force in the circumferential direction, preventing the balloon body from bending due to uneven force, and further improving the accuracy of the expansion action.

[0011] In one alternative implementation, the cone angle of the tapered tip ranges from 30° to 90°.

[0012] Beneficial effects: By setting the cone angle range to 30° to 90°, within this range, the smaller the cone angle of the cone tip, the stronger the stress concentration at the cone tip, making calcified lesions more prone to cracking. When the cone angle of the cone tip is less than 30°, the mechanical strength of the cone tip is low, which easily leads to chipping or wear failure. When the cone angle is greater than 90°, the stress concentration at the cone tip is weak, making it difficult to effectively promote cracking in calcified lesions. Therefore, this invention sets the cone angle range to 30° to 90°, which can both ensure the structural strength of the cone tip and ensure that the stress concentration intensity at the cone tip is sufficient to promote cracking in calcified lesions.

[0013] In one alternative embodiment, the height of the tapered tip ranges from 0.1 mm to 0.4 mm.

[0014] Beneficial effects: After dilating the calcified lesion using the scoring device, a drug-eluting balloon is subsequently used to apply medication to the area where the calcified lesion has been dissected. Based on the structure of the blood vessel, the height of the cone tip should be sufficient to pierce the intima and act on the calcified lesion area, while not causing serious damage to the tunica media of the blood vessel. Moreover, the thickness of different blood vessels varies. When treating coronary artery calcification, the height of the cone tip ranges from 0.1 mm to 0.2 mm; when treating peripheral vascular calcification, the height of the cone tip ranges from 0.2 mm to 0.4 mm.

[0015] In one alternative embodiment, the bottom surface of the conical tip is directly connected to the outer wall of the balloon body; or, The scoring component also includes a base having a first surface and a second surface opposite to each other. The first surface is attached to and connected to the outer wall of the balloon body, and the bottom surface of the conical tip is connected to the second surface. The size of the first surface is larger than the size of the bottom surface of the conical tip.

[0016] Beneficial effects: The conical tip can be directly connected to the outer wall of the balloon body, or it can be connected to the outer wall of the balloon body through the base. When the conical tip is connected to the outer wall of the balloon body through the base, the first surface of the base fits against the outer wall of the balloon body, and the second surface provides support for the conical tip. The expansion force of the balloon body is transmitted to the conical tip through the base. Since the size of the first surface is larger than the size of the bottom surface of the conical tip, the contact area between the scoring element and the balloon body is increased. Compared with the conical tip being directly connected to the outer wall of the balloon body, on the one hand, the connection position between the outer wall of the balloon body and the first surface is less prone to deformation, which is more conducive to keeping the conical tip extending in the radial direction and avoiding displacement of the conical tip. On the other hand, the first surface can increase the connection area between the scoring element and the outer wall of the balloon body, preventing the scoring element from falling off the outer wall of the balloon body.

[0017] In one alternative embodiment, the first surface is circular in shape, the diameter of the first surface ranges from 0.4 mm to 0.8 mm, and the height of the base is greater than 0 mm and less than or equal to 0.3 mm.

[0018] Beneficial effects: Depending on the size of the balloon body and the bottom surface size of the conical tip, the diameter of the first surface can be adjusted within the range of 0.4 mm to 0.8 mm. When the diameter of the first surface is less than 0.4 mm, the area of ​​the first surface is too small, the connection strength between the first surface and the outer wall of the balloon body is too low, and it is easy to fall off. When the diameter of the first surface is greater than 0.8 mm, the size of the first surface is too large, which can easily affect the distribution density of the scoring elements and affect the expansion effect on calcified lesions.

[0019] Depending on the inflated diameter of the balloon body and the height of the conical tip, the height of the base can be adjusted within the range of greater than 0 mm and less than or equal to 0.3 mm. When the height of the base is greater than 0.3 mm, the conical tip is prone to protruding from the protrusion of the balloon body in the contracted state, which will also increase the diameter of the balloon body after contraction, affecting its ability to pass through narrowed blood vessels.

[0020] In one alternative embodiment, the spacing between two adjacent notches ranges from 1 mm to 3 mm along an axial direction parallel to the balloon body.

[0021] Beneficial effects: The spacing between two adjacent notched elements can be adjusted between 1mm and 3mm. When the spacing between two adjacent notched elements is less than 1mm, the distribution of multiple notched elements is too compact, which can easily affect the flexibility of the balloon body. When the spacing between two adjacent notched elements is greater than 3mm, the distribution of multiple notched elements is too sparse, which can easily affect the efficiency of expanding calcified lesions. Therefore, setting the spacing between two adjacent notched elements to 1mm to 3mm can both maintain the flexibility of the balloon body and ensure the efficiency of the notched elements in expanding calcified lesions.

[0022] Secondly, the present invention provides a scoring balloon dilation catheter, including the scoring balloon described above, and further including: a push rod, wherein the scoring balloon is disposed at the distal end of the push rod.

[0023] In one alternative embodiment, the push rod has an inflation cavity and a guidewire cavity, the inflation cavity being in communication with the balloon body, and the guidewire cavity passing through the balloon body and extending outward from the distal end of the balloon body. Attached Figure Description

[0024] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the structure of the notched balloon dilation catheter according to an embodiment of the present invention; Figure 2 This is a schematic cross-sectional view of the notched balloon according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the scoring component according to an embodiment of the present invention; Figure 4 This is a cross-sectional structural diagram of the scoring component according to an embodiment of the present invention; Figure 5 This is a cross-sectional structural diagram of the push rod according to an embodiment of the present invention; Figure 6 This is a cross-sectional structural diagram of another embodiment of the push rod of the present invention.

[0026] Explanation of reference numerals in the attached figures: 1. Scratched balloon; 11. Balloon body; 111. Groove; 112. Protrusion; 12. Scratched part; 121. Conical tip; 122. Base; 1221. First surface; 1222. Second surface; 2. Push rod; 201. Filling chamber; 202. Guide wire chamber; 21. Outer tube; 22. Inner tube; 23. Imaging ring; 3. Catheter hub; 31. Guidewire channel; 32. Filling channel; 4. Stress buffer components. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] The following is combined Figures 1 to 6 The following describes embodiments of the present invention.

[0029] like Figure 1 and Figure 2 As shown, according to an embodiment of the present invention, in one aspect, a notched balloon is provided, comprising: balloon body 11; Multiple scoring elements 12 are disposed on the outer wall of the balloon body 11 and are distributed at intervals along the axial direction parallel to the balloon body 11. Each scoring element 12 includes at least a conical tip 121. When the balloon body 11 is in a contracted state, the outer wall of the balloon body 11 forms adjacent grooves 111 and protrusions 112. Both grooves 111 and protrusions 112 extend in a direction parallel to the axial direction of the balloon body 11. The scoring element 12 is located in the groove 111, and the conical tip 121 does not protrude from the protrusion 112.

[0030] Specifically, the balloon body 11 is a hollow tubular structure with a diameter ranging from 1 mm to 13 mm and a length ranging from 5 mm to 400 mm. The balloon body 11 can be made of materials such as Pebax, nylon, or PET, and can be a single-layer, double-layer, or triple-layer structure. A fiber braided layer can be added to the surface of the balloon body 11 to increase its burst pressure. The rated burst pressure range of the balloon body 11 can be from 18 atm to 50 atm. The scoring element 12 can be made of materials such as stainless steel or cobalt-chromium alloy, or other hard materials with good biocompatibility. The hardness of the scoring element 12 is greater than or equal to 50 HRC, allowing the conical tip 121 to be pressed into the calcified lesion plaque and generate cracks. The cone tip 121 has a cone-shaped structure with a bottom surface and a pointed tip opposite to the bottom surface. When the balloon body 11 expands, it drives the cone tip 121 to move in the radial direction, so that the pointed tip of the cone tip 121 is pressed into the calcified lesion.

[0031] By spaced apart on the outer wall of the balloon body 11, multiple independent scoring elements 12 can be arranged to greatly reduce the constraint of the scoring elements 12 on the deformation of the balloon body 11. Specifically, during the delivery of the balloon body 11, the balloon body 11 is in a contracted state, and the multiple independent scoring elements 12 are accommodated in the groove portion 111, with the conical tip 121 not protruding from the protrusion portion 112. When the balloon body 11 adapts to the curvature of the blood vessel, there is no interaction force between the multiple scoring elements 12, allowing the balloon body 11 to maintain its flexibility and smoothly pass through tortuous lesions, while also ensuring that the scoring elements 12 are not damaged during balloon delivery. The normal vascular endothelium significantly improves the permeability and safety of the notched balloon 1. During the inflation of the balloon body 11, even as the balloon body 11 elongates axially during inflation, the outer wall of the balloon body 11 can expand freely according to the predetermined shape without being restricted, because each notched element 12 is relatively independent and there is no interaction force between them. This avoids the outer wall of the balloon body 11 being bent due to tension, and also avoids the notched elements 12 being displaced due to the bending of the outer wall of the balloon body 11. This ensures that multiple notched elements 12 are pressed into the calcified lesion according to the predetermined position, reducing the difficulty of dilating the calcified lesion.

[0032] Furthermore, since multiple scoring elements 12 are spaced apart along an axial direction parallel to the balloon body 11, the conical tips 121 of the multiple scoring elements 12 can act on the same straight line. As the balloon body 11 expands, the conical tips 121 can be pressed into the calcified lesion in the blood vessel and generate cracks. After multiple scoring elements 12 are pressed in, cracks will be generated. The cracks between two adjacent scoring elements 12 are easy to connect and form gaps. The gaps generated by multiple scoring elements 12 become a whole to expand the calcified lesion, thereby effectively expanding the calcified lesion. Moreover, compared with the scoring wire in the related technology, the contact area between the conical tip 121 and the calcified lesion provided by the present invention is smaller, which makes the puncture ability of the conical tip 121 stronger and easier to be pressed into the calcified lesion. Therefore, the balloon internal pressure required by the conical tip 121 is lower than that required by the scoring wire, which makes the scoring element 12 more efficient in expanding the calcified lesion and can reduce the difficulty of operation.

[0033] Therefore, the notched balloon provided by the present invention can pass through the tortuous lesion more smoothly, avoid the situation of the balloon body 11 bending or the notched part 12 shifting when the balloon body 11 is inflated, and can expand calcified lesions more efficiently, reducing the difficulty of operation.

[0034] like Figure 1 and Figure 2 As shown, in this embodiment, multiple scoring elements 12 distributed along the same straight line are defined as a group along the axial direction parallel to the balloon body 11, and multiple groups of scoring elements 12 are evenly spaced along the circumference of the balloon body 11. Specifically, refer to... Figure 1 Each group of 12 scored parts is distributed along a straight line, for reference. Figure 2 When three sets of scoring elements 12 are set, the included angle between two adjacent sets of scoring elements 12 is 120°. Of course, two, four, five or more sets of scoring elements 12 can be set according to actual needs. Correspondingly, the included angle between two adjacent sets of scoring elements 12 can also be 180°, 90° or 72°. It can be set according to the specifications of the balloon body 11. The larger the diameter of the balloon body 11, the more sets of scoring elements 12 can be set. This will not be explained in detail here.

[0035] With this configuration, as the balloon inflates, multiple sets of notched elements 12 can be pressed into the calcified lesion simultaneously, thereby expanding multiple areas on the calcified lesion corresponding to the multiple sets of notched elements 12, improving the expansion efficiency of the calcified lesion. Furthermore, this configuration ensures that the outer wall of the balloon body 11 is subjected to uniform force in the circumferential direction, preventing the balloon body 11 from bending due to uneven force, and further improving the accuracy of the expansion action.

[0036] like Figure 3 and Figure 4 As shown, in this embodiment, the cone angle of the cone tip 121 ranges from 30° to 90°. Specifically, based on indentation fracture mechanics, the indentation contact radius is proportional to the square of the cone angle tangent. That is, the smaller the cone angle, the stronger the local stress concentration, and the easier it is to generate cracks in calcified lesions. At the same time, considering that a cone angle that is too small is prone to problems such as tip chipping and wear failure, the cone angle range is set to 30° to 90°. Within this range, the smaller the cone angle of the cone tip 121, the stronger the stress concentration of the cone tip 121, making the calcified lesion more prone to cracking. When the cone angle of the cone tip 121 is less than 30°, the mechanical strength of the cone tip 121 is low, which easily causes chipping or wear failure. When the cone angle is greater than 90°, the stress concentration of the cone tip 121 is weak, which is not enough to effectively promote the generation of cracks in calcified lesions. Therefore, the present invention sets the cone angle range to 30° to 90°, which can ensure both the structural strength of the cone tip 121 and the stress concentration intensity of the cone tip 121 is sufficient to promote the generation of cracks in calcified lesions. In this embodiment, the top arc of the conical tip is R0.03m.

[0037] like Figure 4As shown, in this embodiment, the height of the conical tip 121 ranges from 0.1 mm to 0.4 mm, and H1 in the figure represents the height of the conical tip 121. After the calcified lesion is expanded by the scoring element 12, a drug-eluting balloon is subsequently used to apply medication to the area of ​​the calcified lesion dissected by the vessel. Based on the structure of the blood vessel, the height of the conical tip 121 should be sufficient to pierce the intima and act on the calcified lesion area, while not causing serious damage to the tunica media of the blood vessel. Moreover, the thickness of different blood vessels varies. When treating coronary artery calcification, the height of the conical tip 121 ranges from 0.1 mm to 0.2 mm; when treating peripheral vascular calcification, the height of the conical tip 121 ranges from 0.2 mm to 0.4 mm. In addition, multiple conical tips 121 can also form several micropores on the surface of the vascular intima, which is more conducive to the transfer of medication from the surface of the drug-eluting balloon to the vessel wall, thereby more effectively inhibiting the excessive proliferation of smooth muscle cells and reducing the thickening of the vascular intima.

[0038] In this embodiment, the bottom surface of the conical tip 121 is directly connected to the outer wall of the balloon body 11. Specifically, the bottom surface of the conical tip 121 can be fixed to the outer wall of the balloon body 11 by adhesive bonding. For example, the balloon body 11 can first be plasma-treated to increase its surface energy. Adhesive dots can then be evenly and regularly distributed on the surface of the balloon body 11 by spraying or applying adhesive. A polymer-compatible adhesive is preferred to ensure the bonding strength between the adhesive dots and the surface of the balloon body 11. Next, adhesive is applied to the adhesive dots while the scoring element 12 is placed at the application point, and the adhesive covers the scoring element 12. Here, a metal-compatible adhesive is used to ensure the fixing strength of the scoring element 12. All scoring elements 12 are bonded sequentially according to the above steps.

[0039] like Figure 2 and Figure 4 As shown, in another embodiment of this invention, the scoring component 12 further includes a base 122. The base 122 has a first surface 1221 and a second surface 1222 opposite to each other. The first surface 1221 is attached to and connected to the outer wall of the balloon body 11, and the bottom surface of the conical tip 121 is connected to the second surface 1222. The size of the first surface 1221 is larger than the size of the bottom surface of the conical tip 121. Specifically, the base 122 and the conical tip 121 can be integrally formed. The first surface 1221 of the base 122 can be fixed to the outer surface of the balloon body 11 by adhesive bonding. The specific bonding method can be referred to above and will not be repeated here.

[0040] When the conical tip 121 is connected to the outer wall of the balloon body 11 through the base 122, the first surface 1221 of the base 122 fits against the outer wall of the balloon body 11, and the second surface 1222 provides support for the conical tip 121. The expansion force of the balloon body 11 is transmitted to the conical tip 121 through the base 122. Since the size of the first surface 1221 is larger than the size of the bottom surface of the conical tip 121, the contact area between the scoring element 12 and the balloon body 11 is increased. Compared with the conical tip 121 being directly connected to the outer wall of the balloon body 11, on the one hand, the position where the outer wall of the balloon body 11 is connected to the first surface 1221 is less prone to deformation, which is more conducive to keeping the conical tip 121 extending in the radial direction and avoiding displacement of the conical tip 121. On the other hand, the first surface 1221 can increase the connection area between the scoring element 12 and the outer wall of the balloon body 11, preventing the scoring element 12 from falling off the outer wall of the balloon body 11.

[0041] like Figure 4 As shown, in this embodiment, the first surface 1221 is circular in shape, and the diameter of the first surface 1221 ranges from 0.4 mm to 0.8 mm. The height of the base 122 is greater than 0 mm and less than or equal to 0.3 mm.

[0042] Specifically, based on the size of the balloon body 11 and the bottom surface size of the conical tip 121, the diameter of the first surface 1221 can be adjusted within the range of 0.4 mm to 0.8 mm. When the diameter of the first surface 1221 is less than 0.4 mm, the area of ​​the first surface 1221 is too small, the connection strength between the first surface 1221 and the outer wall of the balloon body 11 is too low, and it is easy to fall off. When the diameter of the first surface 1221 is greater than 0.8 mm, the size of the first surface 1221 is too large, which can easily affect the distribution density of the scoring element 12 and affect the expansion effect on calcified lesions.

[0043] It should be noted that the base diameter of the conical tip 121 is determined by the cone angle and the height H1. When the height H1 is fixed, the larger the cone angle, the larger the base diameter of the conical tip 121. When a base 122 is provided, after the diameter of the first surface 1221 is determined, to avoid the base diameter of the conical tip 121 being equal to or greater than the diameter of the first surface 1221, the maximum value of the cone angle needs to be determined based on the diameter of the first surface 1221. The maximum value of the cone angle can be determined according to the following formula. ,in, Where is the maximum cone angle, and D is the diameter of the first surface 1221. When 30° < When <90°, the cone angle ranges from 30° to ;when When the angle is greater than 90°, the cone angle ranges from 30° to 90°.

[0044] For example, when D is 0.4 mm and H1 is 0.4 mm, the result can be calculated using the above formula. Since the cone angle is ≤53.13°, it should be selected within the range of 30° to 53.13°; other values ​​should be selected for D and H1, and the calculation results should be... When the angle is greater than 90°, it means that when the cone angle is less than or equal to 90°, the diameter of the bottom surface of the cone tip 121 will not be greater than or equal to the diameter of the first surface 1221. Therefore, the cone angle can be selected in the range of 30° to 90°.

[0045] Figure 4 H2 shown is the height of the base 122. The height of the base 122 can be adjusted within the range of greater than 0 mm and less than or equal to 0.3 mm, depending on the diameter of the balloon body 11 after inflation and the height of the conical tip 121. When the height of the base 122 is greater than 0.3 mm, the conical tip 121 is prone to protruding beyond the protrusion 112 of the balloon body 11 in the contracted state, which will also increase the diameter of the balloon body 11 after contraction and affect its ability to pass through narrowed blood vessels.

[0046] In this embodiment, the spacing between two adjacent notched elements 12 along the axial direction parallel to the balloon body 11 ranges from 1 mm to 3 mm. The spacing between two adjacent notched elements 12 can be adjusted between 1 mm and 3 mm. When the spacing between two adjacent notched elements 12 is less than 1 mm, the distribution of multiple notched elements 12 is too compact, which can easily affect the flexibility of the balloon body 11. When the spacing between two adjacent notched elements 12 is greater than 3 mm, the distribution of multiple notched elements 12 is too sparse, which can easily affect the efficiency of expanding calcified lesions. Therefore, setting the spacing between two adjacent notched elements 12 to 1 mm to 3 mm can both maintain the flexibility of the balloon body 11 and ensure the efficiency of the notched elements 12 in expanding calcified lesions.

[0047] It should be noted that the spacing between two adjacent scoring elements 12 can be adjusted within the range of 1mm to 3mm according to the specifications of the balloon body 11. The smaller the spacing, the more scoring elements 12 there are in each group, which is more conducive to the expansion of calcified lesions.

[0048] Samples were made using the indented balloon 1 of this embodiment and tested using an expanded plaster tube model. The plaster tube model served as a calcification model, while the comparative example was a regular balloon. To expand the calcification model, a regular balloon required 22 atm, while the indented balloon 1 provided in this embodiment required 10 atm. It can be seen that the indented balloon 1 provided in this embodiment can effectively expand the calcification model with a smaller expansion pressure.

[0049] like Figure 1As shown, in a second aspect, the present invention provides a scoring balloon dilation catheter, including the scoring balloon described above, and further including: a push rod 2, wherein the scoring balloon 1 is disposed at the distal end of the push rod 2.

[0050] Specifically, the distal end refers to the end farther from the user, and the proximal end refers to the end closer to the user. During use, the push rod 2, guided by the guidewire, advances the scoring balloon 1 to the calcified lesion. Once in place, the scoring balloon 1 expands the calcified lesion through the scoring element 12. After expansion is complete, the scoring balloon 1 contracts and is withdrawn from the body by the push rod 2. The specific structure, usage, and beneficial effects of the scoring balloon 1 have been explained in detail above and will not be repeated here.

[0051] like Figure 1 and Figure 5 As shown, in this embodiment, the push rod 2 has an inflation cavity 201 and a guidewire cavity 202. The inflation cavity 201 communicates with the balloon body 11, and the guidewire cavity 202 passes through the balloon body 11 and extends outward from the distal end of the balloon body 11. Specifically, the guidewire cavity 202 allows the guidewire to pass through, and the inflation cavity 201 can inflate liquid or gas into the inner cavity of the balloon body 11, or extract liquid or gas from the inner cavity of the balloon body 11. In use, after the balloon body 11 is pushed into place, liquid or gas can be inflated into the inner cavity of the balloon body 11 through the inflation cavity 201. Inflation stops after the balloon is fully inflated. After expansion is complete, the liquid or gas in the balloon body 11 can be extracted through the inflation cavity 201, causing the balloon body 11 to contract.

[0052] like Figure 1 As shown, in this embodiment, the portion of the push rod 2 that extends into the balloon body 11 is provided with a radiopaque ring 23. For example, the push rod 2 is provided with two radiopaque rings 23, which are located at the proximal end and distal end of the balloon body 11, respectively.

[0053] like Figure 5 As shown, in one embodiment of this invention, the push rod 2 includes an inner tube 22 and an outer tube 21. The outer tube 21 is sleeved on the outside of the inner tube 22, and there is a gap between the inner wall of the outer tube 21 and the outer wall of the inner tube 22. The lumen of the inner tube 22 serves as a guidewire lumen 202, forming an inflation cavity 201 between the inner wall of the outer tube 21 and the outer wall of the inner tube 22. The distal end of the outer tube 21 can be sealed to the proximal end of the balloon body 11. The inner tube 22 extends out of the distal end of the balloon body 11, and the outer wall of the distal end of the inner tube 22 is sealed to the distal end of the balloon body 11. The inner tube 22 and outer tube 21 in this embodiment are common single-lumen tube structures in the art, and will not be described in detail here.

[0054] like Figure 6As shown, in another embodiment of this example, the push rod 2 is a multi-cavity tube structure, integrating a filling cavity 201 and a guide wire cavity 202 that are parallel to each other.

[0055] like Figure 1 As shown, in this embodiment, the proximal end of the push rod 2 is provided with a catheter seat 3. The catheter seat 3 has a guidewire channel 31 and a filling channel 32. The guidewire channel 31 communicates with the guidewire cavity 202, and the filling channel 32 communicates with the filling cavity 201. The proximal end of the push rod 2 extends into the catheter seat 3. A stress buffer 4 can also be provided at the distal end of the catheter seat 3. The stress buffer 4 is sleeved at the connection between the push rod 2 and the catheter seat 3, thereby preventing the push rod 2 from breaking at the catheter seat 3 when subjected to force.

[0056] In this embodiment, the notched balloon dilation catheter is an integral exchangeable balloon catheter, and it can also be designed as a rapid exchangeable balloon catheter.

[0057] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A notched balloon, characterized in that, include: balloon body (11); Multiple scoring elements (12) are disposed on the outer wall of the balloon body (11) and are spaced apart along an axial direction parallel to the balloon body (11). Each scoring element (12) includes at least a conical tip (121). When the balloon body (11) is in a contracted state, the outer wall of the balloon body (11) forms adjacent grooves (111) and protrusions (112). Both the grooves (111) and the protrusions (112) extend in a direction parallel to the axial direction of the balloon body (11). The scoring element (12) is located in the groove (111), and the conical tip (121) does not protrude from the protrusion (112).

2. The notched balloon according to claim 1, characterized in that, Along the axial direction parallel to the balloon body (11), a plurality of the scoring elements (12) distributed along the same straight line are defined as a group, and the plurality of groups of scoring elements (12) are evenly spaced along the circumference of the balloon body (11).

3. The notched balloon according to claim 1, characterized in that, The cone angle of the cone tip (121) ranges from 30° to 90°.

4. The notched balloon according to claim 3, characterized in that, The height of the conical tip (121) ranges from 0.1 mm to 0.4 mm.

5. The notched balloon according to claim 4, characterized in that, The bottom surface of the conical tip (121) is directly connected to the outer wall of the balloon body (11); or, The scoring component (12) also includes a base (122) having a first surface (1221) and a second surface (1222) opposite to each other. The first surface (1221) is attached to and connected to the outer wall of the balloon body (11). The bottom surface of the conical tip (121) is connected to the second surface (1222). The size of the first surface (1221) is larger than the size of the bottom surface of the conical tip (121).

6. The notched balloon according to claim 5, characterized in that, The first surface (1221) is circular in shape, and the diameter of the first surface (1221) ranges from 0.4 mm to 0.8 mm. The height of the base (122) is greater than 0 mm and less than or equal to 0.3 mm.

7. The notched balloon according to any one of claims 1 to 6, characterized in that, Along the axial direction parallel to the balloon body (11), the spacing between two adjacent scoring elements (12) ranges from 1 mm to 3 mm.

8. A notched balloon dilation catheter, characterized in that, The punctured balloon according to any one of claims 1 to 7 further includes a push rod (2), wherein the punctured balloon (1) is disposed at the distal end of the push rod (2).

9. The notched balloon dilation catheter according to claim 8, characterized in that, The push rod (2) has an inflation cavity (201) and a guide wire cavity (202). The inflation cavity (201) is connected to the balloon body (11). The guide wire cavity (202) passes through the balloon body (11) and extends outward from the distal end of the balloon body (11).

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