Balloon catheter

Abstract

The application relates to a balloon catheter. The balloon catheter comprises a balloon, a tube body, a guide wire tube, a plurality of stress concentration elements and at least one stress adjusting film; the tube body is connected with one end of the balloon, a liquid delivery channel is formed in the tube body, the liquid delivery channel is communicated with the balloon, a liquid inlet is arranged at the end of the tube body far from the balloon, and the liquid inlet is communicated with the liquid delivery channel; one end of the guide wire tube is connected with the end of the balloon far from the tube body, the balloon is sleeved outside the guide wire tube, and the guide wire tube passes through the balloon and the tube body; the plurality of stress concentration elements are arranged on the outer surface of the balloon; and the stress adjusting film partially covers or fully covers at least one stress concentration element. According to the scheme, when the balloon is expanded, the stress adjusting film is deformed under pressure, and a more smooth treatment protrusion with a specific treatment profile is formed outside the stress concentration element. The structure can not only effectively act on vascular diseases, but also can disperse the stress borne by the stress concentration element.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to balloon catheters. Background Technology

[0002] Existing specialized balloon dilation catheters include cutting balloons, papillary balloons, notched balloons, and chocolate balloons. These specialized balloons typically improve the treatment effect of vascular stenosis or occlusion symptoms through their special surface structure design. During the procedure, a guidewire is used to advance the specialized balloon catheter to the lesion site. Inflation of the specialized balloon dilates the blood vessel, causing calcification or plaque to move from the center of the vessel lumen towards the vascular system wall, thereby improving blood flow. In conventional treatments, for lesions with severe calcification, heavy plaque burden, or long-term chronic occlusion, the therapeutic effect of specialized balloon dilation catheters is stronger than that of ordinary balloon dilation, and specialized balloons also have a certain ability to dilate calcification.

[0003] See Figure 1 In related technologies, the special structures on the surface of existing special balloons are too strong and can easily damage blood vessels. The blades, papillae, and scoring on the surface of the balloon directly act on calcifications or blood vessels. Due to the excessive stress concentration, vascular dissection or perforation may occur during use. Furthermore, during the retraction of the special balloon, the special structures on the surface of the special balloon may scratch blood vessels. In addition, if the cutting blades or papillae on the special balloon fall off, it will cause significant harm to the patient. Utility Model Content

[0004] To address or partially address the problems existing in the related technologies, this application provides a balloon catheter that can disperse the stress on the pressure concentrator and prevent the pressure concentrator from falling off the balloon.

[0005] This application provides a balloon catheter comprising a balloon, a tubing, a guidewire, a plurality of pressure concentrating elements, and at least one stress-regulating membrane; the tubing is connected to one end of the balloon, and an infusion channel is formed within the tubing, which communicates with the balloon; an inlet is provided at the end of the tubing away from the balloon, and the inlet communicates with the infusion channel; one end of the guidewire is connected to the end of the balloon away from the tubing, the balloon is fitted over the guidewire, and the guidewire passes through the balloon and the tubing; the plurality of pressure concentrating elements are disposed on the outer surface of the balloon; the stress-regulating membrane partially or completely covers at least one of the pressure concentrating elements.

[0006] Furthermore, the pressure concentrating element is columnar, and multiple pressure concentrating elements are distributed at intervals along the circumference and / or axial direction of the balloon.

[0007] Furthermore, the pressure concentrating element is cylindrical or frustum-shaped, with the diameter of the side of the pressure concentrating element near the balloon being 0.4~0.7mm and the diameter of the side of the pressure concentrating element away from the balloon being 0.1~0.7mm.

[0008] Furthermore, the pressure concentrating element is a long strip-shaped convex rib, the pressure concentrating element extends along the axial direction of the tube body, and multiple pressure concentrating elements are distributed at intervals along the circumference of the balloon.

[0009] Furthermore, the pressure concentrating element has multiple through holes, which are distributed at intervals along the axial direction of the tube on the side of the pressure concentrating element.

[0010] Furthermore, the pressure concentrating element has multiple notches, which are distributed at intervals along the axial direction of the tube on the side of the pressure concentrating element opposite to the balloon.

[0011] Furthermore, the length of the pressure concentrating element is 5-30 mm, and the height of the pressure concentrating element is 0.1-0.5 mm.

[0012] Furthermore, multiple pressure concentrating elements are distributed at intervals of 45° to 120° around the central axis of the tube on the outer surface of the balloon.

[0013] Furthermore, the stress-regulating membrane is made of a material that is softer than the balloon material.

[0014] Furthermore, it also includes two developing rings, which are connected to the outer surface of the guide wire tube, and the pressure concentrating element is located between the two developing rings.

[0015] The technical solution provided in this application may include the following beneficial results: By placing the pressure concentrator on the outer surface of the balloon and partially or completely covering at least one pressure concentrator with a stress-regulating membrane, the pressure concentrator is positioned between the balloon and the stress-regulating membrane, preventing the pressure concentrator, which experiences greater stress, from detaching from the balloon and falling into the blood vessel during balloon catheter retraction, thus preventing harm to the patient; by wrapping the pressure concentrator with a stress-regulating membrane, the membrane and the pressure concentrator work synergistically. During balloon expansion, the stress-regulating membrane deforms under pressure, forming a smoother treatment protrusion with a specific treatment contour on the outside of the pressure concentrator. The pressure concentrator can work with the stress-regulating membrane to cut calcified areas and blood spots in the blood vessel, and the stress-regulating membrane disperses the stress on the pressure concentrator during the cutting process, making it less likely for the pressure concentrator to detach from the balloon. This also makes the cutting of calcified areas and blood spots with the stress-regulating membrane smoother, significantly reducing the risk of iatrogenic vascular injury during surgery, thereby improving the safety and therapeutic effect of the surgery.

[0016] The core of this invention lies in the synergistic working mechanism of the "stress-regulating membrane" and the "pressure-concentrating element," rather than a simple physical superposition. This stress-regulating membrane is not a traditional protective sleeve, but an active functional component. During balloon dilation, because the elastic modulus of the stress-regulating membrane is lower than that of the balloon, it undergoes controllable deformation under the compression of the pressure-concentrating element. This transforms the sharp, point-like, and linear stress concentration contour of the pressure-concentrating element into a new, smoother, yet still effective "treatment protrusion." This new contour, while ensuring effective "marking" or "dilation" of calcified plaques, significantly reduces the risk of cutting healthy blood vessel tissue, lowering the incidence of vascular dissection and perforation. The wrapping and deformation of the stress-regulating membrane increases the stress-bearing area between the base of the pressure-concentrating element and the balloon, dispersing the originally concentrated stress. This significantly reduces the risk of the pressure-concentrating element detaching from the weld / bond point during repeated dilation or contact with hard lesions, preventing serious medical accidents caused by the pressure-concentrating element being left inside the blood vessel. During catheter delivery and withdrawal, the smooth, stress-modulating membrane outer surface provides far superior passability compared to exposed pressure-concentrating elements, reducing friction between the device and the vessel wall, especially during withdrawal, preventing scratches to the vessel wall caused by exposed elements.

[0017] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0018] The above and other objects, features and advantages of this application will become more apparent from the more detailed description of exemplary embodiments thereof in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments thereof.

[0019] Figure 1 This is a schematic diagram of a balloon catheter cutting calcified areas of a blood vessel using existing technology;

[0020] Figure 2 This is a schematic diagram of the structure of the balloon catheter shown in the embodiments of this application;

[0021] Figure 3 yes Figure 2 Enlarged view of section A;

[0022] Figure 4 This is a schematic diagram illustrating the cutting of a calcified portion of a blood vessel by a balloon catheter, as shown in an embodiment of this application.

[0023] Figure 5 This is a schematic diagram of the structure of the pressure concentration element shown in the embodiments of this application;

[0024] Figure 6 This is another structural schematic diagram of the pressure concentration element shown in the embodiments of this application;

[0025] Figure 7 This is a schematic diagram showing the pressure concentration elements arranged at 45° intervals on the surface of the balloon, as illustrated in the embodiments of this application.

[0026] Figure 8 This is a schematic diagram showing the pressure concentration elements arranged at 51° intervals on the surface of the balloon, as illustrated in the embodiments of this application.

[0027] Figure 9 This is a schematic diagram illustrating a stress-regulating film covering one of the pressure concentration elements, as shown in an embodiment of this application;

[0028] Figure 10 This is a schematic diagram illustrating a stress-regulating thin film covering a localized pressure concentration element, as shown in an embodiment of this application;

[0029] Figure 11 This is another schematic diagram of a stress-regulating film covering a localized pressure concentration element, as shown in an embodiment of this application.

[0030] Figure reference numerals: 1. Balloon; 2. Tube; 3. Guide wire; 4. Pressure concentrator; 41. Through hole; 42. Notch; 5. Stress adjustment membrane; 6. Luer connector; 7. Imaging ring; 8. End; 9. Calcification area. Detailed Implementation

[0031] Embodiments of this application will now be described in more detail with reference to the accompanying drawings. While embodiments of this application are shown in the drawings, it should be understood that this application may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to make this application more thorough and complete, and to fully convey the scope of this application to those skilled in the art.

[0032] It should be understood that although the terms "first," "second," "third," etc., may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0033] In the description of this application, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0034] Unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0035] In related technologies, the special structure on the surface of special balloons can easily damage blood vessels due to excessive force. Components such as blades, papillae, and scoring on the balloon surface directly act on calcifications or blood vessels. Due to excessive stress concentration, vascular dissection or perforation may occur during use. Furthermore, during balloon retraction, the special structure on the balloon surface may scratch blood vessels. Additionally, if the cutting blades or papillae on the special balloon detach, it will cause significant harm to the patient. To address these problems, this application provides a balloon catheter that can disperse the stress on the pressure concentrator, preventing the pressure concentrator from detaching from the balloon.

[0036] In the description of this application, some key terms need to be defined more clearly:

[0037] "Pressure Concentrating Element 4": This should be broadly understood as any geometric structure disposed on the surface of the balloon 1 to concentrate pressure in a specific area during balloon 1 expansion, thereby achieving indentation, cutting, or high-pressure expansion of diseased tissue (such as calcified plaques). The specific form of the pressure concentrating element 4 is not limited to the columnar or elongated ribs shown in the embodiments of this application, but may also be, but is not limited to: pyramidal, conical, microneedle array, rhomboid block, hemispherical protrusion, or any other polygonal protrusion structure.

[0038] The "stress-modulating membrane 5" is characterized by its physical properties being matched to, yet distinct from, those of the balloon 1. Specifically, the elastic modulus or Shore hardness of the stress-modulating membrane 5 is significantly lower than that of the balloon 1 material it contacts. For example, in a preferred embodiment, if the balloon 1 is made of Pebax 72D material, the stress-modulating membrane 5 may be made of Pebax 40D or a softer polyurethane material, with an elastic modulus that is 10% to 80% of that of the balloon 1. This difference in physical properties is the technical basis for achieving the aforementioned synergistic effect (i.e., forming a new treatment profile and dispersing stress), rather than simply providing protection or coverage.

[0039] The technical solutions of the embodiments of this application are described in detail below with reference to the accompanying drawings.

[0040] See Figure 2 and Figure 3 The balloon catheter includes a balloon 1, a tubing 2, a guidewire 3, multiple pressure concentrating elements 4, and at least one stress-regulating diaphragm 5. The tubing 2 is connected to one end of the balloon 1, and the tubing 2 and balloon 1 can be joined together by welding or adhesive. An infusion channel is formed within the tubing 2, extending axially along the tubing 2 and communicating with the balloon 1. An inlet is located at the end of the tubing 2 furthest from the balloon 1, and this inlet communicates with the infusion channel. When balloon 1 needs to be inflated, physiological saline is injected into the inlet. The saline flows into the balloon 1 through the infusion channel, causing the balloon 1 to inflate continuously.

[0041] See Figure 2 In some embodiments, one end of the tube body 2 is connected to the balloon 1, and one end of the balloon 1 is wrapped around the outer surface of one end of the tube body 2. The end of the tube body 2 connected to the balloon 1 has a liquid outlet, which is connected to the infusion channel. In some embodiments, one end of the tube body 2 extends into the balloon 1, and one end of the balloon 1 is connected to the outer surface of the tube body 2. The side or end of the tube body 2 has a liquid outlet, which is connected to the infusion channel.

[0042] See Figure 2 and Figure 3 One end of the guidewire 3 is connected to the end of the balloon 1 furthest from the tube body 2. The guidewire 3 and the balloon 1 are connected together by welding or adhesive. The balloon 1 is fitted over the guidewire 3, with part of the guidewire 3 inside the balloon 1 and part passing through one end of the balloon 1 and the side of the tube body 2. The other end of the guidewire 3 is outside the tube body 2. The guidewire 3 is not connected to the infusion channel; when saline flows into the infusion channel, the saline will not enter the guidewire 3. The guidewire 3 is used to insert the guidewire and provides a receiving space for the guidewire. The guidewire is a metal guidewire, preferably a stainless steel guidewire. The guidewire can improve the pushability of the balloon catheter, facilitating its movement within the blood vessel. In addition, the metal guidewire can also improve the flexural strength of the balloon catheter, which is beneficial for the transmission of force from the proximal to the distal end of the balloon catheter. The balloon catheter also includes a Luer connector 6, which is connected to the tube body 2.

[0043] See Figure 2-5 Multiple pressure concentrators 4 are disposed on the outer surface of the balloon 1. These pressure concentrators 4 can be welded or bonded to the outer surface of the balloon 1. The pressure concentrators 4 can act on calcified sites 9 and plaques in the blood vessels, scraping the plaques away from the vessels. A stress-regulating membrane 5 partially or completely covers at least one pressure concentrator 4. The edges of the stress-regulating membrane 5 can be welded or bonded to the outside of the balloon 1. The stress-regulating membrane 5 is made of a flexible material. When the balloon 1 inflates, at least one pressure concentrator 4 is sandwiched between the balloon 1 and the stress-regulating membrane 5. The stress-regulating membrane 5 deforms under the pressure of the pressure concentrators 4, and its surface has protrusions and contours corresponding to the positions of the pressure concentrators 4. These protrusions also function as pressure concentrators 4, acting on calcified sites 9 and plaques in the blood vessels. When the balloon 1 is inflated, the pressure concentrators 4 effectively focus pressure, while the portion of the pressure concentrators 4 covering the stress-regulating membrane 5 provides appropriate expansion or anchoring force to treat the lesion in a gentle manner.

[0044] See Figure 2-4Compared with existing balloon catheters, the balloon catheter of this application, by placing the pressure concentrating element 4 on the outer surface of the balloon 1 and partially or completely covering the stress-adjusting membrane 5 outside at least one pressure concentrating element 4, ensures that the pressure concentrating element 4 is positioned between the balloon 1 and the stress-adjusting membrane 5. This prevents the pressure concentrating element 4, which experiences higher stress, from detaching from the balloon 1 and falling into the blood vessel during balloon catheter retraction, thus preventing harm to the patient. Furthermore, by using the stress-adjusting membrane 5 to wrap around the pressure concentrating element 4, the stress-adjusting membrane 5 and the pressure concentrating element 4 work synergistically. When the balloon 1 expands, the stress-adjusting membrane 5 effectively controls the pressure concentration of the pressure concentrating element 4, preventing it from falling into the blood vessel and causing injury to the patient. The segmental membrane 5 deforms under pressure, and the stress-adjusting membrane 5 forms a smoother treatment protrusion with a specific treatment contour on the outside of the pressure concentrating element 4. The pressure concentrating element 4 can work with the stress-adjusting membrane 5 to cut the calcified sites 9 and blood spots in the blood vessels. The stress-adjusting membrane 5 disperses the stress on the pressure concentrating element 4 during the cutting process, making it less likely for the pressure concentrating element 4 to fall off the balloon 1. It also makes it easier for the pressure concentrating element 4 to work with the stress-adjusting membrane 5 to cut the calcified sites 9 and blood spots, significantly reducing the risk of iatrogenic vascular injury during the operation, thereby improving the safety of the operation and the treatment effect.

[0045] See Figure 2 and Figure 3 The balloon catheter also includes a Luer connector 6, which is connected to the tube body 2. The balloon catheter includes a tip 8, which is located at the end of the balloon away from the tube body 2. The tip 8 is connected to the balloon 1 and communicates with the guidewire tube 3, and the guidewire can extend into the tip 8.

[0046] See Figure 3-6 In some embodiments, the pressure concentrating element 4 is columnar, and multiple pressure concentrating elements 4 can be distributed circumferentially along the balloon 1, or axially along the balloon 1. Alternatively, multiple pressure concentrating elements 4 can be distributed circumferentially and axially along the balloon 1. Preferably, all pressure concentrating elements 4 are distributed circumferentially and axially along the balloon 1, thereby ensuring that when the stress-adjusting membrane 5 and the balloon 1 extend into the lesion's blood vessel, the pressure concentrating element 4 acts on a wider range of calcified sites 9 and plaques in the blood vessel, resulting in a more uniform effect.

[0047] See Figure 2-6Specifically, the pressure concentrator 4 is cylindrical or frustum-shaped. The diameter of the side of the pressure concentrator 4 near the balloon 1 is 0.4~0.7mm, the diameter of the side of the pressure concentrator 4 away from the balloon 1 is 0.1~0.7mm, and the height of the pressure concentrator 4 is 0.1-1mm. This ensures that the pressure concentrator 4 will not puncture the stress-regulating membrane 5, and that the pressure concentrator 4 is more likely to form a sharper protrusion on the stress-regulating membrane 5. Preferably, the pressure concentrator 4 is frustum-shaped, and the area of ​​the side of the pressure concentrator 4 connected to the balloon 1 is larger, making the connection between the pressure concentrator 4 and the balloon 1 more secure and less likely to fall off the balloon 1. The area of ​​the side of the pressure concentrator 4 that compresses the stress-regulating membrane 5 is smaller, which makes the protrusion formed by the stress-regulating membrane 5 when compressed by the pressure concentrator 4 sharper and more obvious. This results in better cutting effect of the stress-regulating membrane 5 when cutting blood spots or calcified areas 9 on blood vessels.

[0048] See Figure 3-5In some embodiments, the pressure concentrating element 4 is a long strip-shaped rib. The pressure concentrating element 4 can be made of metal or polymer material. Preferably, the pressure concentrating element 4 can be made of stainless steel alloy. Multiple pressure concentrating elements 4 are distributed circumferentially around the balloon 1 and extend axially along the tube body 2. This improves the continuity of the protrusions formed by the stress-regulating membrane 5 along the axial direction of the tube body 2, resulting in a more continuous axial expansion of the blood vessel when the balloon 1 inflates. The side of the pressure concentrating element 4 that contacts the stress-regulating membrane 5 is curved to prevent the pressure concentrating element 4 from tearing the stress-regulating membrane 5. Multiple through holes 41 are provided on the side of the pressure concentrating element 4, distributed axially along the tube body 2. The through holes 41 make the pressure concentrating element 4 easier to bend, allowing the balloon 1, stress-regulating membrane 5, and pressure concentrating element 4 to pass through the blood vessel more easily when the stress-regulating membrane 5 is inserted into a complex-shaped blood vessel. Preferably, the through holes 41 are T-shaped, ensuring sufficient connection area between the pressure concentrating element 4 and the balloon 1, resulting in a stronger connection. The pressure concentrator 4 has a larger area, making it easier to bend and improving the passage of the balloon catheter through blood vessels. The pressure concentrator 4 has multiple notches 42, spaced apart along the axial direction of the tube body 2 on the side of the pressure concentrator 4 facing away from the balloon 1. These notches 42 facilitate bending, and are staggered from the through-hole 41 along the length of the pressure concentrator 4, ensuring sufficient strength and preventing breakage. The pressure concentrator 4 has a length of 5-30 mm, a height of 0.1-0.5 mm, and a thickness of 0.2-1 mm. Designing the pressure concentrator 4 within this size range avoids occupying excessive space between the balloon 1 and the stress-adjusting membrane 5, ensuring smooth passage of the stress-adjusting membrane 5 through blood vessels. Furthermore, the pressure concentrator 4, in conjunction with an external pressure device, can effectively target blood spots or calcified areas 9 on blood vessels. In some embodiments, the pressure concentrating element 4 is a polygon of other shapes, the maximum outline size of the pressure concentrating element 4 ranges from 0.3 to 0.8 mm, and the height of the pressure concentrating element 4 is from 0.1 to 0.5 mm.

[0049] See Figure 2 and Figure 7 Multiple pressure concentrating elements 4 are distributed at intervals of 45° to 120° around the central axis of the tube body 2 on the outer surface of the balloon 1. In some embodiments, eight rows or eight pressure concentrating elements 4 are arranged circumferentially along the tube body 2 on the outer surface of the balloon 1, and the multiple pressure concentrating elements 4 are distributed at intervals of 45° around the central axis of the tube body 2 on the outer surface of the balloon 1; see also Figure 1 and Figure 6In some embodiments, seven rows or seven pressure concentrating elements 4 are arranged on the outer surface of the balloon 1 along the circumference of the tube 2, and the multiple pressure concentrating elements 4 are distributed on the outer surface of the balloon 1 at intervals of 51° around the central axis of the tube 2; in some embodiments, six rows or six pressure concentrating elements 4 are arranged on the outer surface of the balloon 1 along the circumference of the tube 2, and the multiple pressure concentrating elements 4 are distributed on the outer surface of the balloon 1 at intervals of 60° around the central axis of the tube 2; in some embodiments, five rows or five pressure concentrating elements are arranged on the outer surface of the balloon 1 along the circumference of the tube 2. Component 4, multiple pressure concentrating elements 4 are distributed at 72° intervals around the central axis of the tube body 2 on the outer surface of the balloon 1; in some embodiments, four rows or four pressure concentrating elements 4 are arranged along the circumference of the tube body 2 on the outer surface of the balloon 1, with multiple pressure concentrating elements 4 distributed at 90° intervals around the central axis of the tube body 2; in some embodiments, three rows or three pressure concentrating elements 4 are arranged along the circumference of the tube body 2 on the outer surface of the balloon 1, with multiple pressure concentrating elements 4 distributed at 120° intervals around the central axis of the tube body 2. The arrangement of pressure concentrating elements 4 at different intervals on the outer surface of the balloon 1 can address blood vessels with different degrees of calcification, facilitating targeted treatment by medical personnel based on the patient's condition.

[0050] See Figure 2 and Figure 3 In some embodiments, the stress-regulating membrane 5 completely wraps around the balloon 1 and the pressure-concentrating element 4, with all the pressure-concentrating elements 4 sandwiched between the stress-regulating membrane 5 and the balloon 1. One end of the stress-regulating membrane 5 is welded or bonded to the tube body 2 and the balloon 1, and the other end of the stress-regulating membrane 5 is welded or bonded to the guide wire tube 3. The stress-regulating membrane 5 can disperse the stress of all the pressure-concentrating elements 4, so that when the balloon 1 is retracted, there is no risk of the pressure-concentrating elements 4 falling off.

[0051] In practical use, the extent and number of pressure-concentrating elements 4 covered by the stress-regulating membrane 5 can be adjusted according to the characteristics of the calcified vascular site 9 or the blood spot. (See also...) Figure 7 In some embodiments, if analysis based on the characteristics of the patient's vascular calcification site 9 or blood spot indicates that a pressure concentration element 4 will experience excessive stress during the procedure, the stress-adjusting film 5 can be used to cover only the pressure concentration element 4 experiencing excessive stress, while the other pressure concentration elements 4 are not covered by the stress-adjusting film 5. See also Figure 8 and Figure 9In some embodiments, if it is determined from the analysis of the characteristics of the calcified vascular site 9 or blood spot of the patient that a certain area of ​​the pressure concentration element 4 will be subjected to excessive stress, the stress adjustment film 5 can be designed as a ring and placed on the part of the pressure concentration element 4 where the stress is the greatest. The number of stress adjustment films 5 can be one, two or more, and the number of stress adjustment films 5 and the position of the covering are determined by the analysis results of the calcified vascular site 9 or blood spot of the patient.

[0052] See Figure 2 and Figure 3 The stress-regulating film 5 is made of a softer material than the balloon 1, ensuring that the pressure-concentrating element 4 can generate corresponding protrusions and contours with the stress-regulating film 5. In some embodiments, the balloon 1 adopts a double-layer material design. Preferably, the balloon 1 is made of a combination of nylon and Pebax in a certain proportion, giving the balloon 1 extremely strong pressure resistance. The stress-regulating film 5 can be made of a polymer as the substrate, physically blended with high-density inorganic developer powder, and then made into a film through extrusion, casting, or other processes. The polymer can be one of nylon, Pebax, polyurethane, or polyethylene. Alternatively, it can be configured as a multi-layer co-extruded film, combining a conventional polymer film without developer with a film containing a high concentration of developer, so that the inner and outer surfaces of the film have different properties. For example, the inner layer (contacting the balloon or instrument) of the stress-regulating film 5 uses a common polymer to ensure good heat-sealing performance and flexibility, while the middle or outer layer is a developer layer. By concentrating the developer in a specific layer, its weakening effect on the overall mechanical properties of the film is avoided.

[0053] See Figure 2 and Figure 3 The balloon catheter also includes two contrast rings 7, which are connected to the outer surface of the guidewire 3. The contrast rings 7 are located inside the balloon 1, and the pressure concentrating element 4 is located between the two contrast rings 7. The contrast rings 7 can serve as position markers when the patient takes an X-ray. When the patient takes an X-ray, the position of the two contrast rings 7 can be sensed to understand the specific position of the balloon 1 and the stress adjustment membrane 5, and to better understand the position of the pressure concentrating element 4 in the blood vessel. This makes it easier for medical staff to accurately apply the pressure concentrating element 4 in conjunction with the stress adjustment membrane 5 to the blood spot or calcification site 9 on the blood vessel.

[0054] The solution of this application has been described in detail above with reference to the accompanying drawings. In the above embodiments, the descriptions of each embodiment have different focuses; for parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments. Those skilled in the art should also understand that the actions and modules involved in the specification are not necessarily essential to this application. Furthermore, it is understood that the steps in the method of this application embodiment can be adjusted, combined, and deleted according to actual needs, and the modules in the device of this application embodiment can be combined, divided, and deleted according to actual needs.

[0055] The various embodiments of this application have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or improvement of the technology in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

Claims

1. A balloon catheter, characterized in that, include: balloon; The tube body is connected to one end of the balloon, and an infusion channel is formed inside the tube body. The infusion channel is connected to the balloon, and an inlet is provided at the end of the tube body away from the balloon. The inlet is connected to the infusion channel. A guidewire, one end of which is connected to the end of the balloon away from the tube body, the balloon being fitted over the guidewire, and the guidewire passing through the balloon and the tube body; Multiple pressure concentrating elements are disposed on the outer surface of the balloon; At least one stress-regulating membrane, which partially or completely covers the outside of at least one of the pressure-concentrating elements.

2. The balloon catheter according to claim 1, characterized in that: The pressure concentrating element is columnar, and multiple pressure concentrating elements are distributed at intervals along the circumference and / or axial direction of the balloon.

3. The balloon catheter according to claim 2, characterized in that: The pressure concentrating element is cylindrical or frustum-shaped, with a diameter of 0.4~0.7 mm on the side of the pressure concentrating element near the balloon and a diameter of 0.1~0.7 mm on the side of the pressure concentrating element away from the balloon.

4. The balloon catheter according to claim 1, characterized in that: The pressure concentrating element is a long strip-shaped convex rib, which extends along the axial direction of the tube body, and multiple pressure concentrating elements are distributed circumferentially along the balloon.

5. The balloon catheter according to claim 4, characterized in that: The pressure concentrator has multiple through holes, which are spaced apart along the axial direction of the tube on the side of the pressure concentrator.

6. The balloon catheter according to claim 4, characterized in that: The pressure concentrator has multiple notches, which are spaced apart along the axial direction of the tube on the side of the pressure concentrator facing away from the balloon.

7. The balloon catheter according to claim 4, characterized in that: The length of the pressure concentrator is 5~30mm, and the height of the pressure concentrator is 0.1~0.5mm.

8. The balloon catheter according to claim 2 or 4, characterized in that: Multiple pressure concentrating elements are distributed at intervals of 45° to 120° around the central axis of the tube on the outer surface of the balloon.

9. The balloon catheter according to claim 1, characterized in that: The elastic modulus of the stress-regulating membrane is lower than that of the balloon.

10. The balloon catheter according to claim 1, characterized in that: It also includes two developing rings, which are connected to the outer surface of the guide wire tube, and the pressure concentrating element is located between the two developing rings.

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