WO2023087185A1

WO2023087185A1 - Balloon catheter assembly

Info

Publication number: WO2023087185A1
Application number: PCT/CN2021/131266
Authority: WO
Inventors: 汪令生; 林琳; 王秀伟; 张灯风; 刘继勇; 秦泗海; 李文松
Original assignee: 科塞尔医疗科技（苏州）有限公司
Priority date: 2021-11-17
Filing date: 2021-11-17
Publication date: 2023-05-25
Also published as: CN115666703A

Abstract

A balloon catheter assembly (100), comprising a catheter seat (110), a balloon (120), and a catheter (130), which is connected between the catheter seat (110) and the balloon (120), wherein a constraining structure (140) is wrapped around an outer side of the balloon (120), and the constraining structure (140) comprises a connecting proximal end (141), a connecting distal end (142) and an acting segment (143), which is connected between the connecting proximal end (141) and the connecting distal end (142), the acting segment (143) comprising at least two longitudinal connecting rods (1431) and at least two radial rings (1432), which are connected by means of the at least two longitudinal connecting rods (1431), and each of the connecting segments on the radial rings (1432) comprises a first arcuate segment, a middle segment and a second arcuate segment, which are sequentially connected.

Description

A balloon catheter assembly

technical field

This specification relates to the field of medical devices, in particular to a balloon catheter assembly.

Background technique

The invasive use of percutaneous transluminal angioplasty represents a major advance in the treatment of vascular disease. After years of development, balloon angioplasty has become a relatively mature technology recognized by the medical community. Balloon angioplasty is mainly aimed at the revascularization of narrowed and occluded blood vessels, by inserting a catheter with a dilated balloon into the vascular system, and then under external pressure, the balloon is expanded in the narrowed and occluded area of the blood vessel, and then Radial pressure is applied to the inner walls of blood vessels to widen narrowed, occluded areas and allow blood to flow more freely.

During the inflation process, the dilatation balloon can be constrained by the constraining structure sheathed on its outside, so that it has a certain inflated size and inflated shape. However, it has been found in practical applications that when the balloon is inflated or deflated, the restraint structure may break, which may damage the balloon in the slightest or cause injury to the patient in the worst case. Therefore, for those skilled in the art, it is necessary to study a more reliable balloon catheter assembly and constraint structure.

Contents of the invention

An embodiment of the present specification provides a balloon catheter assembly, including a catheter adapter, a balloon, and a catheter connected between the catheter adapter and the balloon. The outer surface of the balloon is wrapped with a constraint structure, and the constraint structure includes a connecting The proximal end, the connecting distal end and the working section connected between the connecting proximal end and the connecting distal end, the working section includes at least two longitudinal connecting rods and at least two connecting rods connected by the at least two longitudinal connecting rods Two radial rings, each connecting segment on the radial rings sequentially connected includes a first arc segment, a middle segment and a second arc segment.

In some embodiments, an included angle of 85 degrees to 95 degrees is formed between the tangent line of the end of the first arc segment and/or the second arc segment and the longitudinal direction of the longitudinal connecting rod.

In some embodiments, the radius of curvature of the first arc segment and/or the second arc segment is 0.3 mm to 0.45 mm, and the length of the middle segment is the same as that of the first arc segment or the second arc segment. The ratio of the arc lengths of the segments is 3-5.

In some embodiments, the portion of the at least two longitudinal connecting rods between two adjacent radial rings has at least one wave shape.

In some embodiments, the intermediate segment is a straight segment.

In some embodiments, the catheter includes an inner tube, an outer tube sleeved outside the inner tube, and a connecting tube arranged between the outer tube and the balloon, and the distal end of the outer tube is connected to the balloon. The connecting tube is connected, and the inner surface of the connecting tube is connected with the proximal end of the balloon through an adhesive layer.

In some embodiments, the connecting pipe is made of nylon or polyether block polyamide, and the adhesive layer is made of polyether block amide.

In some embodiments, the length of the connecting pipe is 8mm-15mm.

In some embodiments, each connection point between the radial ring and the longitudinal connecting rod forms at least one arc-shaped buffer section.

In some embodiments, the connecting proximal end of the constraining structure is connected to the proximal end of the adhesive layer.

Description of drawings

The embodiments of this specification will be further described in the form of exemplary embodiments, and these exemplary embodiments will be described in detail with the accompanying drawings. These examples are non-limiting, and in these examples, the same number indicates the same structure, wherein:

Fig. 1 is a schematic structural view of a balloon catheter assembly according to some embodiments of the present specification.

Fig. 2 is a schematic diagram of a constraining structure of a balloon catheter assembly according to some embodiments of the present specification.

Fig. 3 is a schematic structural view of a radial ring of a balloon catheter assembly according to some embodiments of the present specification.

Fig. 4 is a schematic diagram of a constraining structure of a balloon catheter assembly according to other embodiments of the present specification.

Fig. 5 is a partially enlarged schematic view of a balloon catheter assembly according to some embodiments of the present specification.

Fig. 6 is a schematic diagram of the connection of the adhesive layer of the balloon catheter assembly according to some embodiments of the present specification.

Fig. 7 is a schematic diagram of wire connections of the constraining structure of the balloon catheter assembly according to some embodiments of the present specification.

8 is a schematic cross-sectional view of a wire of a constraining structure of a balloon catheter assembly according to some embodiments of the present specification.

Detailed ways

In order to more clearly illustrate the technical solutions of the embodiments of the present specification, the following briefly introduces the drawings that need to be used in the description of the embodiments. Apparently, the accompanying drawings in the following description are only some examples or embodiments of this specification, and those skilled in the art can also apply this specification to other similar scenarios. It should be understood that these exemplary embodiments are given only for the purpose of enabling those skilled in the relevant art to better understand and implement this specification, but not to limit the scope of this specification in any way. Unless otherwise apparent from context or otherwise indicated, like reference numerals in the figures represent like structures or operations.

As indicated in the specification and claims, the terms "a", "an", "an" and/or "the" are not specific to the singular and may include the plural unless the context clearly indicates an exception. Generally speaking, the terms "comprising" and "comprising" only suggest the inclusion of clearly identified steps and elements, and these steps and elements do not constitute an exclusive list, and the method or device may also contain other steps or elements. The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment".

In the description of this specification, it should be understood that the orientation or positional relationship indicated by the terms "far end", "near end", "inside", "outside", "far away from", "near", "one end" etc. are Based on the orientation or positional relationship shown in the drawings, it is only for the convenience of describing this specification and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood for the limitation of this manual.

In this specification, unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense. For example, "connection" can be a fixed connection or a Detachable connection, or integration; it can be directly connected, or indirectly connected through an intermediary; it can be the internal communication of two elements, or it can indicate that there is an interactive relationship between the two elements. Unless otherwise clearly defined, those of ordinary skill in the art can understand the specific meanings of the above terms in this specification according to specific situations.

In the process of using balloon angioplasty to revascularize narrowed and occluded blood vessels, the balloon catheter can be constrained by the constraining structure sheathed on its outside, so that it has a certain expansion size and shape, so that the blood vessels are affected The force is more even. However, in some practical applications, it is found that when the balloon is inflated or deflated, the constraining structure may break due to stretching or bending, thereby damaging the balloon, and even causing serious damage to the patient's blood vessels.

In view of the above problems, some embodiments of the present specification provide a balloon catheter assembly, the balloon catheter assembly improves the constraining structure, and the working section of the improved constraining structure includes at least two longitudinal connecting rods and at least two At least two radial rings connected by two longitudinal connecting rods, wherein the part of the radial ring between two adjacent longitudinal connecting rods constitutes a connecting segment, and each connecting segment includes successively connected first circles Arc segment, intermediate segment, and second arc segment. When the balloon is inflated, the connection segment needs to be expanded in the transverse direction perpendicular to the longitudinal direction of the whole balloon, and the total distance between the first arc segment, the middle segment and the second arc segment needs to be adjusted according to the working time of the balloon inflation. The size is limited within a certain range, so as to avoid incomplete lateral expansion of the balloon when inflated, and the binding effect on the balloon cannot be achieved. In some embodiments, the middle section is designed as a straight section, so that the maximum distance can be obtained during lateral deployment, so as to prevent the balloon from breaking due to insufficient distance between the two longitudinal connecting rods during expansion, while the straight section The design can keep the connecting segment in a straight line state as far as possible when it is fully expanded, so that it intersects with the longitudinal connecting rod at right angles to achieve a better cutting effect. At the same time, by limiting the radius of curvature R of the first arc segment and/or the second arc segment to 0.3 mm to 0.45 mm, a curvature that can sufficiently reduce stress can be obtained, preventing the balloon from being caused by stress during inflation or contraction. The problem occurs when the balloon ruptures during inflation or deflation.

The balloon catheter assembly provided by the embodiment of this specification will be described in detail below with reference to the accompanying drawings.

Referring to FIG. 1 , in some embodiments, a balloon catheter assembly 100 may include a catheter adapter 110, a balloon 120, and a catheter 130 connected between the catheter adapter 110 and the balloon 120, wherein the balloon 120 is wrapped with a coating for limiting Constraining structure 140 for balloon inflated size and inflated shape.

In some embodiments, balloon catheter assembly 100 can include one or more balloons 120 that can be expanded or deflated under the control of an operator (eg, a physician or nurse). When the balloon 120 expands, it can act on the inner wall of the blood vessel, thereby expanding the narrowed and occluded area in the blood vessel, and then widening the narrowed and occluded area in the blood vessel, so that the blood flow is smoother.

In some embodiments, when the balloon catheter assembly 100 includes a plurality (eg, two or more) of balloons 120 , the plurality of balloons 120 may be arranged equidistantly or unequally in a certain order.

In some embodiments, the plurality of balloons 120 can be divided into distal balloons and proximal balloons according to their distance relationship with the catheter adapter 110 . Wherein, the distal balloon may refer to one or more balloons far away from the catheter adapter 110 among the plurality of balloons, and similarly, the proximal balloon may refer to one or more balloons near the catheter adapter 110 among the plurality of balloons. balloon.

In some embodiments, the material of the balloon 120 may be one or more of nylon, nylon copolymer, or polyterephthalate plastic (such as PET (Polyethylene terephthalate, polyester resin)).

Catheter adapter 110 may be used to connect or secure catheter 130 . In some embodiments, the catheter 130 may include multiple inner lumens (such as a guide wire lumen, a distal balloon expansion lumen, a proximal balloon expansion lumen, a drug-carrying lumen, etc.), and the catheter adapter 110 may be respectively provided with a catheter The interface corresponding to each inner cavity of 130.

For example, in some possible embodiments, the catheter adapter 110 may include a first interface, a second interface, a third interface and a fourth interface, and the first interface may be connected to the guide wire lumen of the catheter 130 for operation When guiding through the guide wire or detecting the pressure in the lumen; the second interface can communicate with the distal balloon expansion cavity of the catheter 130, the third interface can communicate with the proximal balloon expansion cavity of the catheter 130, the second interface and The third interface can be used to inject liquid or gas into the distal balloon and the proximal balloon during the operation, so as to control the expansion of the balloons in a certain order or simultaneously, and temporarily expand the balloons at both ends. Block the blood flow to form a closed "vascular cavity"; the fourth interface can communicate with the drug-loaded cavity of the catheter 130, so that the filling device can be used to withdraw and then inject through the fourth interface during the operation, so that the closed blood vessel cavity The blood dissolves the loaded intraluminal drug and then returns to the lumen of the closed vessel.

It should be noted that the above structures of the catheter adapter 110 and the catheter 130 are only illustrative. In some other embodiments, the catheter 130 may include more or fewer lumens, and accordingly, the catheter adapter 110 may include more or fewer interfaces.

Constraining structure 140 may wrap around balloon 120, thereby limiting its inflated size and inflated shape. Referring to FIG. 2 , in some embodiments, the constraining structure 140 may include a proximal connection 141, a distal connection 142, and a connection between the proximal connection 141 and the distal connection 142 and acts on the balloon 120 to limit its expansion size and Active section 143 of expanded shape. Wherein, the connecting proximal end 141 may refer to an end close to the catheter adapter 110 , and the connecting distal end 142 may refer to an end away from the catheter adapter 110 .

Referring to Fig. 2, in some embodiments, the connecting proximal end 141 of the constraint structure 140 may include at least two first longitudinal connecting rods 1411, the connecting distal end 142 may include at least two second longitudinal connecting rods 1421, and the active section 143 may Including at least two third longitudinal connecting rods 1431 , the first longitudinal connecting rod 1411 , the second longitudinal connecting rod 1421 , and the third longitudinal connecting rod 1431 can be arranged along the length extension direction of the conduit 130 . Wherein, the first longitudinal connecting rod 1411, the second longitudinal connecting rod 1421 and the third longitudinal connecting rod 1431 can respectively refer to the arrangement along the extending direction of the length of the constraining structure 140, and are respectively located at the connecting proximal end 141, the connecting distal end 142 and the functional The segment 143 is a rod-like or wire-like structure, and one end of the third longitudinal connecting rod 1431 can be connected with the first longitudinal connecting rod 1411 or the second longitudinal connecting rod 1421 .

Continuing to refer to FIG. 2 , the working section 143 further includes at least two radial rings 1432 arranged along the circumference of the conduit 130 and sequentially connected to the third longitudinal connecting rod 1431 located at the working section 143 , the at least two radial rings 1432 They may be arranged at intervals along the extending direction of the length of the conduit 130 . Wherein, the radial ring 1432 may refer to the rod-shaped or filamentary structure arranged along the circumference of the constraining structure 140, and the part between two adjacent third longitudinal connecting rods 1431 constitutes a connecting segment of the radial ring 1432 . The connecting segment includes a first arc segment, a middle segment and a second arc segment connected in sequence. During the inflation or contraction process of the balloon 120, the connecting segment can expand and contract synchronously with the shape change of the balloon 120. More details about the connection segment can be found elsewhere in this specification (for example, FIG. 3 and related discussions), and will not be described in detail here.

In some embodiments, the first longitudinal connecting rod 1411 connected to the proximal end 141 and/or the second longitudinal connecting rod 1421 connected to the distal end 142 can be connected to other components of the balloon catheter assembly 100 (such as the proximal end of the catheter 130 ). and/or distal) to fix the constraining structure 140. One end of the third longitudinal connecting rod 1431 located at the working section 143 can be connected with the first longitudinal connecting rod 1411 located at the connecting proximal end 141 or the second longitudinal connecting rod 1421 located at the connecting distal end 142 to realize fixation, and the other end is connected with the distance Its fixed end is connected with a radial ring furthest away. For example, when one end of the third longitudinal connecting rod 1431 is fixedly connected to the first longitudinal connecting rod 1411 at the connecting proximal end through the fixed point 1433, the other end can be connected to a radial ring closest to the connecting distal end 142 through the connecting point 1434. Connection; when one end of the third longitudinal connecting rod 1431 is fixedly connected with the second longitudinal connecting rod 1421 located at the far end of the connection through the fixed point 1435, the other end can be connected with a radial ring closest to the proximal end 141 through the connecting point 1436 connect. During the expansion or contraction of the balloon 120, the distance between two adjacent third longitudinal connecting rods 1431 will change accordingly, and one end of the third longitudinal connecting rods 1431 connected to the radial ring can also be relative to The fixed end moves.

In some embodiments, the constraining structure 140 may be a memory alloy stent formed by integral cutting. Wherein, the fixed ends of two adjacent third longitudinal connecting rods 1431 may both be located at the connecting proximal end or connecting distal end of the constraint structure 140, or the fixed end of one third longitudinal connecting rod 1431 may be located at the connecting proximal end of the constraining structure 140. end, and the fixed end of another third longitudinal connecting rod 1431 is located at the connecting distal end of the constraint structure 140 . For example, in some embodiments, the fixed ends of four consecutive third longitudinal connecting rods 1431 can be respectively arranged in the manner of connecting proximal end, connecting distal end, connecting proximal end, and connecting distal end. At this time, there are adjacent The case where the fixed ends of the two third longitudinal connecting rods 1431 are located at different ends of the restraint structure 140 . For another example, in some embodiments, the fixed ends of the four consecutive third longitudinal connecting rods 1431 can be respectively arranged in the manner of connecting the proximal end, connecting the proximal end, connecting the distal end, and connecting the distal end. At this time, there are relative The fixed ends of the adjacent two third longitudinal connecting rods 1431 are located at the same end of the constraint structure 140 . In other words, the two intersections between the radial ring at one end of the constraint structure 140 and the two adjacent third longitudinal connecting rods 1431 may both be the fixed ends of the adjacent two longitudinal connecting rods, or both may be the same. Adjacent to the movable ends of the two longitudinal connecting rods, one of the intersection points may be the fixed end of one of the longitudinal connecting rods, and the other intersection point may be the movable end of the other longitudinal connecting rod.

2, in some embodiments, the third longitudinal connecting rod 1431 may include at least one non-linear structure between two adjacent radial rings 1432, such as a wavy structure, a non-closed trapezoidal structure (such as Figure 2). This non-linear configuration can expand as balloon 120 is inflated. In some embodiments, the fully expanded length of the third longitudinal connecting rod 1431 may be equal to or close to the expanded distance between the connecting proximal end 141 and the connecting distal end 142 . In some embodiments, the cumulative expandable distance L of each third longitudinal connecting rod 1431 may be between 0.8 mm and 1.5 mm. In some embodiments, in order to ensure the consistency of the expansion performance of the third longitudinal connecting rods 1431 and the integrity of the shape of the constraining structure 140 after expansion, the difference between the accumulated expandable distances L of different third longitudinal connecting rods 1431 can be Control within 1mm. Wherein, the accumulative expandable length of the third longitudinal connecting rod 1431 may refer to the sum of the expandable lengths of multiple non-linear structures contained in one third longitudinal connecting rod 1431, or the sum of the expandable lengths of the third longitudinal connecting rod 1431 and the radial ring. The total length that one end of the 1432 connection can move relative to the fixed end.

By arranging the part of the third longitudinal connecting rod 1431 between two adjacent radial rings 1432 to include at least one non-linear structure, it can be more conducive to the expansion and contraction of the constraining structure 140 . Specifically, the more the number of non-linear structures and the greater the distance between peaks and valleys, the greater the length difference between the expansion and contraction of the third longitudinal connecting rod 1431 . In some embodiments, the expansion performance and the contracted minimum size of the constraining structure 140 can be adjusted by adjusting the number of non-linear structures and/or the peak-to-valley distance. For example, when it is necessary to reduce the minimum size of the constraining structure after contraction, the peak-to-valley distance of the non-linear structure can be reduced, so that when the balloon 120 is contracted, a smaller retraction diameter can be obtained; when it is necessary to increase the constraining structure The number and/or peak-to-valley distance of the non-linear structures can be increased at the expanded maximum size.

Referring to FIG. 3 , the part of the radial ring 1432 between two adjacent third longitudinal connecting rods 1431 can form a connecting segment 14321, and each connecting segment 14321 can include first circular arc segments 14321- 1. The middle section 14321-2 and the second arc section 14321-3. In some embodiments, the middle segment 14321-2 may be a straight segment, and its length s may be between 0.5 mm and 1.5 mm. The first circular arc segment 14321-1 and the second circular arc segment 14321-3 are respectively bent toward the two sides of the middle segment 14321-2. In some embodiments, the angle between the tangent of the end of the first arc segment 14321-1 and/or the second arc segment 14321-3 connected to the third longitudinal connecting rod 1431 and the third longitudinal connecting rod 1431 It can be between 85°-95°. Exemplarily, in some embodiments, the included angle may be 85 degrees to 90 degrees; in some embodiments, the included angle may be 87 degrees to 93 degrees; in some embodiments, the included angle may be 90 degrees degrees to 95 degrees.

In some embodiments, the radius of curvature R of the first arc segment 14321-1 and/or the second arc segment 14321-3 may be 0.3mm˜0.45mm. In some embodiments, the ratio of the length s of the middle segment 14321-2 to the arc length of the first arc segment 14321-1 or the second arc segment 14321-3 may be between 3 and 5. In some embodiments, the radii of the first arc segment 14321-1 and the second arc segment 14321-3 may be the same or different, and their arc lengths may also be the same or different.

In some embodiments, the middle segment 14321-2 can also be a curved segment, such as a circular arc. In some embodiments, the curve segment can form an S shape or a wave shape together with the first arc segment 14321-1 and the second arc segment 14321-3 (the wave shape can be regarded as multiple S shapes, or multiple sine Curve), broken line. In some embodiments, when the curve segment can form a broken line together with the first arc segment 14321-1 and the second arc segment 14321-3, in order to avoid the stress at the bend of the radial ring during stretching If it is too concentrated, the connection between the broken line segments can be set to have a smooth transition and have a relatively large bending angle. For example, in some embodiments, the bending angle can be 160-180 degrees.

In some embodiments, the surface roughness of the constraining structure 140 can be reduced and its corrosion resistance can be improved by electrolytic polishing. However, when the constraining structure 140 is processed by electrolytic polishing, the third longitudinal connecting bar The number of 1431 is greater than the number of the first longitudinal connecting rod 1411 connected to the proximal end 141 and/or the second longitudinal connecting rod 1421 connected to the distal end 142, resulting in the first longitudinal connecting rod 1411 connected to the proximal end 141 and/or the second longitudinal connecting rod 1421 connected to the distal end 141. The current passing through the second longitudinal connecting rod 1421 at the end 142 is greater than the current passing through the third longitudinal connecting rod 1431 at the active section 143, thereby causing the first longitudinal connecting rod 1411 at the proximal end 141 and/or the third longitudinal connecting rod 1431 at the distal end 142 to pass through. The width loss of the two longitudinal connecting rods 1421 after polishing is too large, which leads to certain potential safety hazards in the restraint structure 140 . Therefore, in order to avoid excessive width loss of the first longitudinal connecting rod 1411 connected to the proximal end 141 and/or the second longitudinal connecting rod 1421 connected to the distal end 142 after polishing, in some embodiments, the The width of the first longitudinal connecting rod 1411 connected to the proximal end 141 and/or the width of the second longitudinal connecting rod 1421 connected to the distal end 142 is increased to compensate for the rod width lost during the electrochemical polishing process.

Based on this, in some embodiments, the width of at least one longitudinal connecting rod located at the connecting proximal end 141 and/or connecting distal end 142 may be greater than the width of the third longitudinal connecting rod 1431 located at the working section 143, so as to ensure that the third longitudinal connecting rod 1431 located at the connecting The first longitudinal connecting rod 1411 at the proximal end 141 and/or the second longitudinal connecting rod 1421 connected to the distal end 142 and the third longitudinal connecting rod 1431 at the working section 143 have a predetermined width after electropolishing. It should be noted that the "width" of the longitudinal connecting rod described in this specification may refer to the dimension perpendicular to the extending direction of the longitudinal connecting rod.

Referring to FIG. 4 , in some embodiments, the first longitudinal connecting rod 1411 located at the connecting proximal end 141 and the second longitudinal connecting rod 1421 located at the connecting distal end 142 can be located on the same straight line or in a substantially parallel state. The third longitudinal connecting rod 1431 of 143 can be connected with a radial ring including several S-shaped structures (in some embodiments, the aforementioned connecting segments), so as to form a mesh structure wrapped around the balloon 120 . Wherein, "approximately parallel" between the first longitudinal connecting rod 1411 at the connecting proximal end 141 and the second longitudinal connecting rod 1421 at the connecting distal end 142 may mean that the angle between them is less than or equal to 15°.

Referring to FIG. 4 , in some embodiments, the number of the third longitudinal connecting rods 1431 located at the active section 143 may be the first longitudinal connecting rods 1411 located at the connecting proximal end 141 or the second longitudinal connecting rods 1421 located at the connecting distal end 142 In other words, the current flowing through the first longitudinal connecting bar 1411 and the second longitudinal connecting bar 1421 may be twice the current flowing through the third longitudinal connecting bar 1431 .

Based on this, in some embodiments, in order to ensure that the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 located at the connecting proximal end 141 and/or connecting the distal end 142 are connected to the third longitudinal connecting rod located at the working section 143 1431 has a width that meets the predetermined requirements after electropolishing, and the width of the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 connected to the proximal end 141 and/or connected to the distal end 142 before electrolytic polishing can be set as an effective 1.5 times to 4 times the width of the third longitudinal connecting rod 1431 of the segment 143 .

Optionally, in some embodiments, the width of the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 may also be 2 to 4 times the width of the third longitudinal connecting rod 1431; in some embodiments , the width of the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 may also be 1.5 to 3.5 times the width of the third longitudinal connecting rod 1431; in some embodiments, the first longitudinal connecting rod 1411 and/or Or the width of the second longitudinal connecting rod 1421 may also be 1.5 to 3 times the width of the third longitudinal connecting rod 1431; in some embodiments, the width of the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 It may also be 2 to 3 times the width of the third longitudinal connecting rod 1431 .

In some embodiments, the width W1 of the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 located at the connecting proximal end 141 and/or connecting the distal end 142 before electropolishing may be between 0.2 mm and 0.3 mm , the width W2 of the third longitudinal connecting rod 1431 located in the working section 143 before electropolishing may be between 0.08 mm and 0.15 mm.

It should be noted that, the above quantitative relationship between the third longitudinal connecting rod 1431 and the first longitudinal connecting rod 1411 and/or the second longitudinal connecting rod 1421 is only an exemplary description. In some embodiments, the ratio of the number of the third longitudinal connecting rods 1431 to the number of the first longitudinal connecting rods 1411 or the second longitudinal connecting rods 1421 may be less than or greater than 2, correspondingly, the first longitudinal connecting rods 1411 or the second The ratio of the width of the longitudinal connecting rod 1421 to the width of the third longitudinal connecting rod 1431 may be less than 2 or greater than 4.

Fig. 5 is a schematic structural view of a balloon catheter assembly according to some other embodiments of the present specification.

As shown in FIG. 5 , in some embodiments, the catheter 130 may include a stress spreading tube 131 , an inner tube 132 , an outer tube 133 sheathed outside the inner tube 132 , and an outer tube 133 disposed between the outer tube and the proximal end 1201 of the balloon. Connection pipe 134 . Wherein, one end of the stress diffusion tube 131 is connected to the catheter adapter 110 , and the other end is connected to the proximal end of the outer tube 133 . The distal end of the outer tube 133 is connected to the proximal end of the connecting tube 134 , and the distal end of the connecting tube 134 is connected to the proximal end 1201 of the balloon 120 through the adhesive layer 135 .

In some embodiments, the inner tube 131 may be a tubular element, such as a round tube, a square tube, or other regular/irregular shaped elements. In some embodiments, the inner tube 131 may include multiple inner lumens, such as a guide wire lumen, a distal balloon expansion lumen, a proximal balloon dilatation lumen, and a drug-carrying lumen, which are respectively used to accommodate the guide wire, the distal end Inflation with gas or liquid, proximal expansion with gas or liquid, active drug, etc.

In some embodiments, the inner tube 131 can be made of metal or polymer materials, such as stainless steel, polyamide, polyether block amide, polyurethane, and the like. In some embodiments, the inner wall and/or the outer wall of the inner tube 131 may include a lubricating coating, such as polytetrafluoroethylene coating, to reduce its frictional resistance.

In some embodiments, the outer tube 133 may be braided with wire. Moreover, in order to make the outer tube 133 have better directionality when entering the vascular system, in some embodiments, the metal wire used therein may be a flat wire (that is, a flat metal wire).

In some embodiments, in order to reduce the size of the outer tube 133, the metal wire can be stainless steel wire or nickel-titanium wire, preferably a flat stainless steel or nickel-titanium wire with a thickness less than 0.2mm for braiding, such as 0.1mm, 0.08mm, 0.15mm etc., so that the inner diameter of the entire outer tube 133 is controlled at 0.6 mm to 1.2 mm, and the outer diameter is correspondingly controlled at 0.8 mm to 1.4 mm.

In some embodiments, the outer tube 133 may include an outer layer and an inner layer, and the material of the outer layer and/or the inner layer may be polyimide, polyether block amide, or polytetrafluoroethylene. In some embodiments, in order to control the thickness of the outer layer and/or the inner layer to be less than 0.2mm, the metal wire can be directly wound on the inner layer of the outer tube 133, or the metal wire can be co-extruded with the outer layer and/or the inner layer .

In some embodiments, the outer tube 133 can be bonded to the stress diffusion tube 131 by an adhesive, for example, the stress diffusion tube 131 and the outer tube 133 can be positioned, and then the adhesive can be added. Capillary action occurs in the narrow space between the two, so that the two are fully adhered. Exemplary adhesives may include polyimide adhesives, polytetrafluoroethylene adhesives, and the like.

In some embodiments, in order to enhance the pushability and twistability of the balloon 120 , the connection between the distal end of the outer tube 133 and the proximal end of the balloon 120 can be connected through a connecting tube 134 and an adhesive layer 135 .

In some embodiments, the distal end of the outer tube 133 can be connected to the proximal end of the connecting tube 134 , and the distal end of the connecting tube 134 can be connected to the proximal end 1201 of the balloon 120 through the adhesive layer 135 . In some embodiments, in order to reduce the outer diameter of the catheter 130 as much as possible, the adhesive layer 135 may be connected to the outer surface of the connecting tube 134 and/or the inner surface of the proximal end 1201 of the balloon 120 .

In some embodiments, in order to achieve sufficient adhesion, the adhesive layer 135 can simultaneously conform to the inner surface of the proximal end 1201 of the balloon 120, the outer surface of the distal end of the connecting tube 134, and the cross-section of the distal end of the connecting tube 134. bonding.

In some embodiments, the radial dimensions of the outer tube 133 and the balloon 120 may have a certain difference. The connecting pipe 134 may be a variable-diameter structure. Specifically, the size of the two ends of the connecting tube 134 can be different, wherein the size of the end near the outer tube 133 can be the same as or close to the size of the outer tube 133, and the size of the end near the balloon proximal end 1201 can be close to the size of the balloon. Ends 1201 are the same or close in size.

In some embodiments, in order to make the balloon section have better twistability, a connecting tube 134 made of softer material can be used to connect the outer tube 133 and the proximal end 1201 of the balloon 120 . In some embodiments, the connecting tube 134 and the adhesive layer 135 can be made of different soft materials.

In some embodiments, in order to facilitate bonding, the adhesive layer 135 may use a material with a lower melting point. In some embodiments, the melting point of the material used for the adhesive layer 135 may be lower than the melting point of the material used for the connecting tube 134 .

In some embodiments, the connecting pipe 134 can be made of nylon or polyether block polyamide (PEBAX), and the adhesive layer 135 can be made of polyether block amide (PEBA).

In some embodiments, considering that the soft material can increase the torsion performance, it will also lead to poor push performance at the same time. Therefore, by setting the adhesive layer 135 at the connecting pipe 134, on the one hand, the soft material can be made The connecting pipe 134 is slightly thickened to increase its toughness. On the other hand, because the material used in the adhesive layer 135 has a low melting point, it can also be melted quickly when heated, thereby firmly connecting the distal end of the outer pipe 133 and the ball. The proximal end 1201 of the capsule.

6 is a schematic illustration of an adhesive layer of a balloon catheter assembly according to some embodiments of the present specification.

Referring to FIG. 6 , in some embodiments, in order to achieve sufficient adhesion between the adhesive layer 135 and the connecting tube 134 and the proximal end 1201 of the balloon, the adhesive layer 135 may be configured as an L-shaped structure in section. Specifically, the adhesive layer 135 may include a first connection part 135-1 and a second connection part 135-2, wherein the thickness of the first connection part 135-1 is greater than the thickness of the second connection part 135-2, and the first The connecting part 135 - 1 can be connected with the section of the distal end of the connecting tube 134 and the inner surface of the proximal end 1201 of the balloon at the same time, and the second connecting part 135 - 2 can be connected with the outer surface of the connecting tube 134 . It should be noted that, connecting the connecting tube 134 and the proximal end 1201 of the balloon through the adhesive layer 135 with an L-shaped structure in section can increase the connection area between the two, thereby making the connection relationship between the two more reliable.

In some embodiments, the adhesive layer 135 may be thermally welded by using a laser, radiating metal jaws, RF energy, or other methods. In some embodiments, the thermal welding temperature can be controlled to be divided into three heating stages: in the first stage, the welding temperature is raised to 100°C-110°C for 20s-30s, so that the adhesive layer 135 is softened; in the second stage, the welding The temperature rises to 150° C. to 160° C. and lasts for 80s to 100s to fully weld the adhesive layer 135 .

In some embodiments, it has been found through experiments that when the length of the connecting pipe 134 is too long (for example: greater than 15mm), the pushing force cannot be transmitted, and the pushing performance is deteriorated, while when the length of the connecting pipe 134 is too short (for example: : less than 8mm), the twisting performance will be deteriorated due to the close distance of multiple welding points.

Based on the above test results, in some embodiments, in order to ensure the comprehensiveness of the torsion performance and push performance of the balloon segment, the length of the connecting tube 134 can be controlled between 8 mm and 15 mm. Optionally, in some embodiments, the length of the connecting pipe 134 may be 8 mm to 10 mm; in some embodiments, the length of the connecting pipe 134 may be 10 mm to 15 mm; in some embodiments, the length of the connecting pipe 134 may be 9mm ~ 12mm.

In some embodiments, it is considered that the twisting performance and pushing performance of the balloon segment are also related to factors such as the thickness of the connecting tube 134 , whether to add the adhesive layer 135 , and the thickness of the adhesive layer 135 . In order to ensure the comprehensiveness of the torsion performance and push performance of the balloon segment, in some embodiments, an adhesive layer 135 can be provided at the junction of the connecting tube 134 and the proximal end 1201 of the balloon, and the thickness of the adhesive layer 135 It is controlled between 0.1 mm and 0.2 mm, and the thickness of the connecting pipe 134 is controlled between 0.1 mm and 0.2 mm.

In order to verify the feasibility of the above thickness of the adhesive layer 135 and the thickness of the connecting pipe 134 , the applicant conducted corresponding tests. Exemplary test results are shown in the table below:

It can be seen from the above table that when an adhesive layer 135 is provided at the connection between the connecting tube 134 and the proximal end 1201 of the balloon, and the thickness of the adhesive layer 135 is controlled between 0.1 mm and 0.2 mm, the thickness of the connecting tube 134 When controlled between 0.1 mm and 0.2 mm, the balloon catheter assembly 100 has a larger maximum pushing force and better cornering ability (that is, has better twisting performance and pushing performance). Exemplarily, in some embodiments, the thickness of the connecting pipe 134 can be set to 0.1 mm, and the thickness of the adhesive layer 135 can be set to 0.2 mm; in some embodiments, the thickness of the connecting pipe 134 can be set to 0.2 mm. mm, the thickness of the adhesive layer 135 is set to 0.1 mm.

In some embodiments, in order to meet the peripheral requirements, the length of the balloon 120 may be 20mm-40mm, and the diameter may be 5mm-16mm. Optionally, in some embodiments, the length of the balloon 120 may be 20 mm to 30 mm, and the diameter may be 5 mm to 10 mm; in some embodiments, the length of the balloon 120 may be 25 mm to 35 mm, and the diameter may be 8 mm to 12mm.

In some embodiments, the balloon 120 can be a single-layer balloon made of nylon or nylon copolymer, or polyterephthalate plastic, or the inner layer can be polytetraphthalate plastic, and the outer layer The layer is a double-layer balloon made of nylon. It should be noted that the constraining structure 140 may have a sharp end due to local fatigue fracture during use. Once the sharp end is pierced on the balloon, it is easy to puncture the balloon. Therefore, in some embodiments , by setting the balloon 120 as a double-layer balloon made of polyethylene terephthalate plastic on the inner layer and nylon on the outer layer, the material can be selected and matched in terms of cost, weight, and anti-stab performance, and the reinforcement can be enhanced. the safety of the balloon.

In some embodiments, the constraining structure 140 may be a memory alloy stent formed by integral cutting (for example, laser integral cutting). Exemplary memory alloys may include nickel-titanium alloys, copper-nickel alloys, and the like. Referring to Fig. 2, Fig. 4 and Fig. 5, in some embodiments, the memory metal stent may include several metal wires, which can be divided into first longitudinal connecting rods 1411 located at the connecting proximal end 141 according to their positions or shapes. , the second longitudinal connecting rod 1421 located at the connecting distal end 142, the third longitudinal connecting rod 1431 located at the working section 143, and the first longitudinal connecting rod 1411 located at the connecting proximal end/the second longitudinal connecting rod located at the connecting distal end 1421/The third longitudinal connecting rods 1431 located in the working section are criss-cross connected radial rings comprising a plurality of S-shaped structures (in some embodiments, they may be the aforementioned connecting sections).

In some embodiments, a plurality of S-shaped structures may be arranged in an array along the direction in which the balloons 120 are arranged. Wherein, each row forms a wave-shaped radial ring, and each radial ring can be connected with the first longitudinal connecting rod 1411 located at the proximal end, the second longitudinal connecting rod 1421 located at the distal end, and the third longitudinal connecting rod 1421 located at the active section. At least one of the longitudinal connecting rods 1431 is connected. In some embodiments, in order to make the constraining structure 140 have substantially the same constraining force on the balloon 120 at different positions, the multiple radial rings may have the same spacing.

The radial ring formed by the S-shaped structure can expand or contract with the state of the balloon 120, thereby limiting the expanded size and expanded shape of the balloon 120. In other words, the radial ring formed by the S-shaped structure can fit The balloon 120 expands longitudinally and radially during inflation, and can maintain the balloon 120 in a desired position during inflation.

In some embodiments, the total length of the radial ring formed by the S-shaped structure after expanding with the balloon 120 is smaller than the maximum circumference of the expanded balloon 120 . In some embodiments, different radial rings may be configured to have substantially the same contraction performance and circumference in order to make the radial rings have substantially the same constraining effect on the balloon 120 .

In some embodiments, at least one circular arc-shaped buffer section can be formed at at least one connection intersection point 1437 of each metal wire in the memory metal stent. Specifically, the connection intersection of any two metal wires in the memory metal stent forms a rounded or arc-shaped structure during cutting, thereby avoiding the expansion or contraction of the connection intersection 1437 of each metal wire due to excessive stress concentration. In the process, the stent breaks, which may cause serious damage to the blood vessel. In addition, by setting the connection intersection point 1437 as a rounded or arc-shaped structure, compared with a sharp-angled or right-angled structure, it can also prevent the balloon 120 from being damaged due to too sharp force on the balloon 120 .

Referring to FIG. 7 , in some embodiments, the rounded or arc-shaped structure formed by the connection intersection of the metal wire during cutting can be a section of arc with a radius of curvature R1, and the arc can be concave or concave relative to the connection intersection. Convex. In some embodiments, the radius of curvature R1 corresponding to the rounded corner or arc-shaped structure can be between 0.5 mm and 1 mm, wherein, the radius of curvature R1 corresponding to the rounded corner or arc-shaped structure at each connection point can be The same or different, the arc lengths corresponding to the rounded corners or arc-shaped structures at the connection intersections may also be the same or different.

In some embodiments, the connecting proximal end 141 of the constraining structure 140 may be connected at the proximal end of the adhesive layer 135 (eg, the second connecting portion 135 - 2 ) or at the proximal end 1201 of the balloon. In some embodiments, by connecting the connecting proximal end 141 of the constraining structure 140 to the proximal end of the adhesive layer 135 (eg, the second connecting portion 135-2), compared to connecting to the proximal end 1201 of the balloon, It can avoid that the connecting proximal end 141 of the constraining structure 140 expands together with the balloon, so as to achieve a better restraint effect, and, compared with connecting at the proximal end 1201 of the balloon, it can also reduce the pressure of the catheter 130 to a certain extent. overall outside diameter.

The connecting distal end 142 of the constraint structure 140 may be connected to the distal end of the balloon 120 , wherein the distal end of the balloon 120 may refer to the position where the balloon 120 is farthest from the catheter adapter 110 . In some embodiments, the connecting distal end 142 of the constraining structure 140 can be fixedly connected to the distal end of the balloon 120 by bonding or clamping. Similarly, the connecting proximal end 141 of the constraining structure 140 can also be bonded. Or the way of clamping is fixedly connected with the proximal end of the adhesive layer 135 or the proximal end 1201 of the balloon.

Referring to FIG. 8 , in some embodiments, the cross-section of the wire in the constraining structure 140 can be one of trapezoidal (as shown in 8A), triangular (as shown in 8B) or circular (as shown in 8C) or more, the cross-section may refer to a cross-section perpendicular to the extending direction of the length of the metal wire. In some embodiments, the radial dimension of the wires in the constraining structure 140 may be 0.1 mm-0.2 mm. It should be noted that the above cross-sectional shape of the metal wire is only an example. In the embodiment of this specification, the cross-sectional shape of the metal wire may be, but not limited to, the trapezoidal, triangular, and circular shapes described above. For example, in some embodiments, the cross-sectional shape of the metal wire may also be a rectangle.

In some embodiments, the outer surface of balloon 120 may be used to coat the drug. In some embodiments, the drug can be applied to the outer surface of the balloon 120 in a one-time application. In some other embodiments, an opening that communicates with the drug-loaded cavity inside the catheter 130 may be opened between two adjacent balloons 120, and the drug may also be delivered through the drug-loaded cavity provided in the catheter 130, and via a corresponding The opening opened between two adjacent balloons reaches the outer surface of the balloon 120 and/or the outer surface of the constraint structure 140 , or is directly dissolved in the blood vessel lumen. In some embodiments, the balloon catheter assembly 100 can also include a developing component, and the drug can be accurately delivered to the target position to be treated according to the internal image of the blood vessel acquired by the developing component, so as to improve the treatment of the drug on the inner wall of the blood vessel to a certain extent. Effect.

In some embodiments, in order to improve the passability of the constraining structure 140, the constraining structure 140 can be formed by selecting a metal wire with a trapezoidal cross-section, and the lower bottom surface 810 of the metal wire with a trapezoidal cross-section faces outward (that is, away from the balloon). 120), or select a metal wire with a triangular cross-section, and make the longest side (for example 821) of the three sides face outward (ie away from the balloon 120). Considering that when the cross-sectional shape of the metal wire is triangular, the force acting on the balloon 120 on the side facing the balloon 120 may be relatively sharp (that is, the force generated per unit area is relatively large), therefore, in order to avoid the balloon During the expansion process, the force generated by the metal wire is too sharp and damaged. In some embodiments, the area of the side of the wire facing the balloon 120 and in contact with the balloon 120 can be increased, for example, the direction in the triangle can be increased. The angle of one corner of the balloon 120 makes it an obtuse angle greater than 120°, thereby increasing the contact area between the metal wire and the balloon 120 during balloon inflation and reducing the effect of its unit area on the balloon force. In some embodiments, the outer surface of the constraining structure may be provided with a drug coating. In some embodiments, the drug coating can only be provided on the outer surface of the balloon but not on the outer surface of the constraining structure, because if it is disposed on the outer surface of the constraining structure, the balloon will cause the wires of the constraining structure to The part will form a concave part relative to the balloon, which cannot touch the inner wall of the blood vessel, so that the drug cannot be released.

In some embodiments, the drug coating on the outer surface of the balloon may contain at least one other active drug other than macrolide drugs, for example, selected from paclitaxel and its derivatives, rapamycin and its derivatives, At least one of a phosphodiesterase inhibitor, a thrombin inhibitor, a thymidine kinase inhibitor, an antibiotic, and adenosine. It should be noted that the above drugs are only illustrative, and in the embodiment of this specification, the drug coating on the outer surface may be but not limited to the above-mentioned exemplified drugs.

The basic concept has been described above, obviously, for those skilled in the art, the above detailed disclosure is only an example, and does not constitute a limitation to this description. Although not expressly stated here, those skilled in the art may make various modifications, improvements and corrections to this description. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

Meanwhile, this specification uses specific words to describe the embodiments of this specification. Such as "one embodiment", "an embodiment", and/or "some embodiments" means a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that two or more references to "an embodiment" or "an embodiment" or "an alternative embodiment" in different places in this specification do not necessarily refer to the same embodiment . In addition, certain features, structures or characteristics in one or more embodiments of this specification may be properly combined.

In the same way, it should be noted that in order to simplify the expression disclosed in this specification and help the understanding of one or more embodiments of the invention, in the foregoing description of the embodiments of this specification, sometimes multiple features are combined into one embodiment, drawings or descriptions thereof. This method of disclosure does not, however, imply that the subject matter of the specification requires more features than are recited in the claims. Indeed, embodiment features are less than all features of a single foregoing disclosed embodiment.

In some embodiments, numbers describing the quantity of components and attributes are used. It should be understood that such numbers used in the description of the embodiments use the modifiers "about", "approximately" or "substantially" in some examples. grooming. Unless otherwise stated, "about", "approximately" or "substantially" indicates that the stated figure allows for a variation of ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximations that can vary depending upon the desired characteristics of individual embodiments. In some embodiments, numerical parameters should take into account the specified significant digits and adopt the general digit reservation method. Although the numerical ranges and parameters used in some embodiments of this specification to confirm the breadth of the range are approximations, in specific embodiments, such numerical values are set as precisely as practicable.

Each patent, patent application, patent application publication, and other material, such as article, book, specification, publication, document, etc., cited in this specification is hereby incorporated by reference in its entirety. Application history documents that are inconsistent with or conflict with the content of this specification are excluded, as are documents (currently or hereafter appended to this specification) that limit the broadest scope of the claims. It should be noted that if there is any inconsistency or conflict between the descriptions, definitions, and/or terms used in the accompanying materials of this manual and the contents of this manual, the descriptions, definitions and/or terms used in this manual shall prevail .

Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other modifications are also possible within the scope of this description. Therefore, as examples and not limitations, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly introduced and described in this specification.

Claims

A balloon catheter assembly, comprising a catheter base, a balloon and a catheter connected between the catheter base and the balloon, the outside of the balloon wraps a constraining structure, and the constraining structure includes a connecting proximal end, a connecting distal end end and a working section connected between the connecting proximal end and the connecting distal end, wherein the working section includes at least two longitudinal connecting rods and at least two connecting rods connected by the at least two longitudinal connecting rods. A radial ring, each connecting segment on the radial ring sequentially connected includes a first arc segment, a middle segment and a second arc segment.
The assembly according to claim 1, wherein an included angle of 85° to 95° is formed between the end tangent of the first arc segment and/or the second arc segment and the longitudinal direction of the longitudinal connecting rod .
The assembly according to claim 1, wherein the radius of curvature of the first arc segment and/or the second arc segment is 0.3 mm to 0.45 mm, and the length of the middle segment is the same as that of the first arc segment. The ratio of the arc lengths of the arc segment or the second arc segment is 3-5.
The assembly according to claim 1, wherein a portion of said at least two longitudinal connecting rods between two adjacent radial rings has at least one wave shape.
The assembly of claim 1, wherein the intermediate section is a straight section.
The assembly according to claim 1, wherein the catheter comprises an inner tube, an outer tube sheathed outside the inner tube, and a connecting tube arranged between the outer tube and the balloon, the The distal end of the outer tube is connected to the connecting tube, and the inner surface of the connecting tube is connected to the proximal end of the balloon through an adhesive layer.
The assembly according to claim 6, wherein the connecting pipe is made of nylon or polyether block polyamide, and the adhesive layer is made of polyether block amide.
The assembly according to claim 6 or 7, characterized in that the length of the connecting pipe is 8mm-15mm.
The assembly according to claim 1, wherein each connection point between the radial ring and the longitudinal connecting rod forms at least one arc-shaped buffer section.
The assembly of claim 6, wherein the connecting proximal end of the constraining structure is connected to the proximal end of the adhesive layer.