CN115666703A

CN115666703A - Balloon catheter assembly

Info

Publication number: CN115666703A
Application number: CN202180034467.6A
Authority: CN
Inventors: 汪令生; 林琳; 王秀伟; 张灯风; 刘继勇; 秦泗海; 李文松
Original assignee: Kossel Medtech Suzhou Co ltd
Current assignee: Kossel Medtech Suzhou Co ltd
Priority date: 2021-11-17
Filing date: 2021-11-17
Publication date: 2023-01-31
Also published as: WO2023087185A1

Abstract

The utility model provides a sacculus catheter assembly (100), including pipe seat (110), sacculus (120) and pipe (130) of connection between pipe seat (110) and sacculus (120), sacculus (120) outside parcel restraint structure (140), restraint structure (140) are including connecting near-end (141), connect distal end (142) and connect near-end (141), connect effect section (143) between distal end (142), effect section (143) include at least two longitudinal connecting rod (1431) and at least two radial ring (1432) of connecting through at least two longitudinal connecting rod (1431), each connection section on radial ring (1432) connects gradually including first circular arc section, interlude and second circular arc section.

Description

Balloon catheter assembly

Technical Field

The present description relates to the field of medical devices, and more particularly, to a balloon catheter assembly.

Background

The invasive use of percutaneous transluminal angioplasty is a significant advance in the treatment of vascular disease. Over the years of development, balloon angioplasty has been a well-established technique that is well recognized in the medical community. Balloon angioplasty is mainly aimed at revascularization of stenotic and occluded blood vessels by inserting a catheter with an inflatable balloon into the vascular system, then inflating the balloon within the stenotic and occluded area in the blood vessel under an externally applied pressure, and further applying a radial pressure to the inner wall of the blood vessel to widen the stenotic and occluded area and make the blood flow more unobstructed.

The expansion saccule can be restrained by a restraining structure sleeved outside the expansion saccule in the expansion process, so that the expansion saccule has certain expansion size and expansion shape. However, in practice, it has been found that the constraining structure may break when the balloon is inflated or deflated, which may damage the balloon if light, and cause injury to the patient if heavy. Therefore, there is a need for a more reliable balloon catheter assembly and constraining structure for those skilled in the art.

Disclosure of Invention

The embodiment of the specification provides a sacculus catheter assembly, including pipe seat, sacculus and connect the pipe between the pipe seat with the sacculus, the sacculus outside parcel restraint structure, restraint structure is including connecting the near-end, connecting the distal end and connecting connect the near-end, connect the effect section between the distal end, the effect section includes two piece at least longitudinal connecting rods and passes through two at least radial rings of two at least longitudinal connecting rods connection, each connection segmentation on the radial ring is connected gradually including first circular arc section, interlude and second circular arc section.

In some embodiments, an included angle of 85 degrees to 95 degrees is formed between a tangent of an end of the first circular arc segment and/or the second circular 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 0.3mm to 0.45mm, and the ratio of the length of the middle segment to the arc length of the first arc segment or the second arc segment is 3 to 5.

In some embodiments, the portion of the at least two longitudinal connecting rods between two adjacent radial rings is at least one undulation.

In some embodiments, the middle section is a straight section.

In some embodiments, the catheter comprises an inner tube, an outer tube sleeved outside the inner tube, and a connecting tube arranged between the outer tube and the balloon, wherein the distal end of the outer tube is connected with the connecting tube, 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 tube 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 tube is 8mm to 15mm.

In some embodiments, each connection point on the radial ring between the longitudinal connecting rod and the radial ring forms at least one circular arc buffer segment.

In some embodiments, the proximal attachment end of the constraining structure is attached to the proximal end of the adhesive layer.

Drawings

The embodiments of the present specification will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals refer to like structures, wherein:

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

Fig. 2 is a schematic view of a constraining structure of a balloon catheter assembly of some embodiments of the present description.

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

Fig. 4 is a schematic view of a constraining structure of a balloon catheter assembly according to further embodiments of the present disclosure.

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

Fig. 6 is a schematic view of the attachment of an adhesive layer of a balloon catheter assembly according to some embodiments of the present disclosure.

Fig. 7 is a schematic view of a wire connection of a constraining structure of a balloon catheter assembly according to some embodiments of the present description.

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

Detailed Description

In order to more clearly illustrate the technical solutions of the embodiments of the present specification, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only examples or embodiments of the present description, and that for a person skilled in the art, the present description can also be applied to other similar scenarios on the basis of these drawings without inventive effort. It is to be understood that these exemplary embodiments are given solely to enable those skilled in the relevant art to better understand and implement the present description, and are not intended to limit the scope of the present description in any way. Unless otherwise apparent from the context, or stated otherwise, like reference numbers in the figures refer to the same structure or operation.

As used in this specification and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include 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 the present specification, it is to be understood that the terms "distal", "proximal", "inner", "outer", "distal", "near", "end", and the like, indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are used only for convenience in describing and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be considered as limiting the present specification.

In this specification, unless explicitly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, "connected" can be a fixed connection, a removable connection, or an integral part; can be directly connected or indirectly connected through an intermediate medium; communication between the interior of two elements may be possible, as well as the fact that two elements have an interactive relationship. Unless otherwise specifically defined, the specific meanings of the above terms in the present specification can be understood by those of ordinary skill in the art as appropriate.

In the process of reconstructing blood circulation of a narrow and occluded blood vessel by using balloon angioplasty, the balloon catheter can be restrained by a restraining structure sleeved outside the balloon catheter, so that the balloon catheter has certain expansion size and expansion shape, and the stress of the blood vessel is more uniform. However, in some applications, it has been 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 injury to the patient's blood vessel.

In view of the above problems, some embodiments of the present disclosure provide a balloon catheter assembly, which improves a constraining structure, and an acting section of the improved constraining structure includes at least two longitudinal connecting rods and at least two radial rings connected to the at least two longitudinal connecting rods, where a portion of each radial ring located between two adjacent longitudinal connecting rods forms a connecting segment, and each connecting segment includes a first arc segment, a middle segment, and a second arc segment that are sequentially connected. This connection section needs expand on the vertical vertically of whole sacculus when the sacculus inflation, and the total distance of first circular arc section, interlude and second circular arc section needs prescribe a limit to certain within range according to the size when the sacculus inflation work to transversely expand incompletely when avoiding the sacculus inflation, do not play the constraint effect to the sacculus. In some embodiments, the design that the interlude is the straightway both can be so that obtain the biggest distance when transversely unfolding to prevent that the sacculus from breaking because the distance between two longitudinal tie rods is not enough in the inflation in-process, the design of straightway can keep the segmentation of connecting in the rectilinear state as far as possible when unfolding completely simultaneously, makes it intersect with the longitudinal tie rod right angle thereby reach better cutting effect. Meanwhile, by limiting the curvature radius R of the first circular arc section and/or the second circular arc section to be 0.3 mm-0.45 mm, the curvature capable of sufficiently reducing stress can be obtained, and the balloon is prevented from being broken in the expansion or contraction process due to the stress problem in the expansion or contraction process.

The following provides a detailed description of a balloon catheter assembly according to an embodiment of the present disclosure with reference to the drawings.

Referring to fig. 1, in some embodiments, a balloon catheter assembly 100 may include a catheter hub 110, a balloon 120, and a catheter 130 coupled between the catheter hub 110 and the balloon 120, wherein the balloon 120 is externally wrapped with a constraining structure 140 for limiting the balloon's inflated size and shape.

In some embodiments, the balloon catheter assembly 100 may include one or more balloons 120, and the one or more balloons 120 may be expanded or contracted under the control of an operator (e.g., a physician or nurse). When the balloon 120 is expanded, the balloon can act on the inner wall of the blood vessel, so that the narrow and blocked areas in the blood vessel are expanded, the narrow and blocked areas in the blood vessel are widened, and the blood flow is more smooth.

In some embodiments, when the balloon catheter assembly 100 includes a plurality of (e.g., two or more) balloons 120, the plurality of balloons 120 may be arranged in an order, equidistantly or non-equidistantly.

In some embodiments, the plurality of balloons 120 may be divided into distal balloons and proximal balloons according to their distance relationship with the catheter hub 110. Where a distal balloon may refer to one or more of the plurality of balloons distal to catheter hub 110, and similarly, a proximal balloon may refer to one or more of the plurality of balloons proximal to catheter hub 110.

In some embodiments, the material of the balloon 120 may be one or more of nylon, nylon copolymer, or poly-terephthalic plastic (e.g., PET (Polyethylene terephthalate)).

Catheter hub 110 may be used to connect or secure catheter 130. In some embodiments, the catheter 130 may include a plurality of internal cavities (e.g., a guidewire lumen, a distal balloon inflation lumen, a proximal balloon inflation lumen, a drug-loaded lumen, etc.), and the catheter hub 110 may be provided with respective ports corresponding to the respective internal cavities of the catheter 130.

For example, in some possible embodiments, the catheter hub 110 may include a first port, a second port, a third port, and a fourth port thereon, and the first port may be connected to a guidewire lumen of the catheter 130 for intraoperative guidance through a guidewire or for sensing pressure within the lumen; the second interface can be communicated with the far balloon expansion cavity of the catheter 130, the third interface can be communicated with the near balloon expansion cavity of the catheter 130, and the second interface and the third interface can be used for injecting liquid or gas into the far balloon and the near balloon respectively during operation so as to control the balloon bodies to expand sequentially or simultaneously and enable the balloon bodies at the two ends to expand to temporarily block blood flow, thereby forming a closed blood vessel cavity; the fourth port may be in communication with the drug-loaded lumen of catheter 130 for an initial withdrawal and subsequent infusion by the insufflator through the fourth port during a procedure, such that blood within the enclosed vascular cavity dissolves the drug-loaded lumen and then returns to the enclosed vascular cavity.

It should be noted that the above structures of catheter hub 110 and catheter 130 are merely exemplary. In some other embodiments, catheter 130 may include more or fewer internal lumens and, accordingly, more or fewer ports on catheter hub 110.

The constraining structure 140 may be wrapped around the outside of the balloon 120, limiting its expanded size and shape. Referring to fig. 2, in some embodiments, the constraining structure 140 may include a connecting proximal end 141, a connecting distal end 142, and an acting segment 143 connected between the connecting proximal end 141 and the connecting distal end 142 and acting on the balloon 120 to limit its inflated size and inflated shape. Where connection proximal end 141 may refer to the end proximal to catheter hub 110 and connection distal end 142 may refer to the end distal to catheter hub 110.

Referring to fig. 2, in some embodiments, the proximal connecting end 141 of the constraining structure 140 may include at least two first longitudinal connecting rods 1411, the distal connecting end 142 may include at least two second longitudinal connecting rods 1421, the acting section 143 may include at least two third longitudinal connecting rods 1431, and the first longitudinal connecting rod 1411, the second longitudinal connecting rods 1421, and the third longitudinal connecting rods 1431 may be disposed along the length extension direction of the catheter 130. The first longitudinal connecting rod 1411, the second longitudinal connecting rod 1421, and the third longitudinal connecting rod 1431 may be respectively disposed in the constraint structure 140 along the length extension direction thereof, and respectively located in a rod-like or wire-like structure connecting the proximal end 141, the distal end 142, and the action section 143, and one end of the third longitudinal connecting rod 1431 may be connected to the first longitudinal connecting rod 1411 or the second longitudinal connecting rod 1421.

With continued reference to fig. 2, the action section 143 further comprises at least two radial rings 1432 arranged along the circumference of the guide tube 130 and connected in series to the third longitudinal connecting rod 1431 located in the action section 143, and the at least two radial rings 1432 may be arranged at intervals along the length extension direction of the guide tube 130. The radial ring 1432 may refer to a rod-like or wire-like structure disposed along the circumference of the constraint structure 140, and a portion between two adjacent third longitudinal connecting rods 1431 constitutes a connecting segment of the radial ring 1432. The connecting section comprises a first arc section, a middle section and a second arc section which are sequentially connected, and the connecting section can synchronously stretch along with the shape change of the saccule 120 in the process of expansion or contraction of the saccule 120. More details about this connection segment can be found elsewhere in this specification (e.g., fig. 3 and its associated discussion), and will not be described in detail here for the time being.

In some embodiments, the first longitudinal connecting rod 1411 at the proximal end 141 and/or the second longitudinal connecting rod 1421 at the distal end 142 may be coupled to other components of the balloon catheter assembly 100 (e.g., the proximal and/or distal ends of the catheter 130) to secure the constraining structure 140. The third longitudinal connecting bar 1431 located in the active segment 143 can be connected at one end to the first 1411 connecting proximal end 141 or to the second 1421 connecting distal end 142 for fixation and at the other end to a radial ring furthest from the end to which it is fixed. For example, while one end of the third longitudinal connecting rod 1431 is fixedly connected to the first longitudinal connecting rod 1411 at the proximal end of the connection by means of the fixing point 1433, the other end can be connected to a radial ring closest to the distal end 142 of the connection by means of the connection point 1434; while one end of the third longitudinal connecting bar 1431 is fixedly connected to the second longitudinal connecting bar 1421 located at the distal end of the connection by a fixing point 1435, the other end can be connected to a radial ring located closest to the proximal end 141 of the connection by a connection point 1436. During the inflation or deflation of the balloon 120, the distance between two adjacent third longitudinal connecting rods 1431 changes, and the end of the third longitudinal connecting rod 1431 connected to the radial ring can move relative to the fixed end.

In some embodiments, the constraining structure 140 may be a memory alloy stent integrally cut and formed. The fixed ends of two adjacent third longitudinal connecting rods 1431 may be both located at the connection proximal end or the connection distal end of the constraint structure 140, or the fixed end of one third longitudinal connecting rod 1431 is located at the connection proximal end of the constraint structure 140, and the fixed end of another third longitudinal connecting rod 1431 is located at the connection distal end of the constraint structure 140. For example, in some embodiments, the fixed ends of four consecutive third longitudinal connecting rods 1431 may be respectively located at the proximal end, the distal end, the proximal end and the distal end, in this case, the fixed ends of two adjacent third longitudinal connecting rods 1431 may be located at different ends of the constraint structure 140. For another example, in some embodiments, the fixed ends of four consecutive third longitudinal connecting rods 1431 may be respectively located at the near end, the far end, and the far end, in this case, the fixed ends of two adjacent third longitudinal connecting rods 1431 may be located at the same end of the constraint structure 140. In other words, two intersection points of the radial ring at one end of the constraint structure 140 and the two adjacent third longitudinal connecting rods 1431 may be both fixed ends of the two adjacent longitudinal connecting rods, or both movable ends of the two adjacent longitudinal connecting rods, or one of the intersection points may be a fixed end of one of the longitudinal connecting rods, and the other intersection point may be a movable end of the other longitudinal connecting rod.

Referring to fig. 2, in some embodiments, the portion of the third longitudinal connecting rod 1431 between two adjacent radial rings 1432 can include at least one non-linear structure, such as a wavy structure, a non-closed trapezoidal structure (as shown in fig. 2). The nonlinear structure may expand as the balloon 120 is inflated. In some embodiments, the fully expanded length of the third longitudinal connecting rod 1431 may be equal to or near 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 connection rod 1431 may be between 0.8mm and 1.5 mm. In some embodiments, to ensure consistency of the expansion properties of the third longitudinal connection rod 1431 and integrity of the expanded morphology of the constraining structure 140, the difference in the cumulative expandable distance L of the different third longitudinal connection rods 1431 may be controlled to within 1mm. The cumulative expandable length of the third longitudinal connection rod 1431 may refer to the sum of the expandable lengths of the plurality of nonlinear structures included in one third longitudinal connection rod 1431, or the total length of the end of the third longitudinal connection rod 1431 connected to the radial ring 1432 that can move relative to the fixed end.

The constraint structure 140 can be further facilitated by arranging the portion of the third longitudinal connecting bar 1431 between two adjacent radial rings 1432 to include at least one non-linear structure. Specifically, the greater the number of nonlinear structures, the greater the peak-to-valley distance, and the greater the difference in length between the expansion and contraction of the third longitudinal connecting rod 1431. In some embodiments, the expansion properties and the minimum size after contraction of the constraining structure 140 can be adjusted by adjusting the number of nonlinear structures and/or the peak-to-valley distance. For example, when it is desired to reduce the minimum size of the constraining structure after contraction, the peak-to-valley distance of the nonlinear structure can be reduced, thereby allowing a smaller withdrawal diameter to be achieved upon contraction of the balloon 120; the number of nonlinear structures and/or the peak-to-valley distance may be increased when it is desired to increase the maximum expanded dimension of the constraining structure.

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

Referring to fig. 3, a portion of the radial ring 1432 between two adjacent third longitudinal connecting rods 1431 may constitute one connecting segment 14321, and each connecting segment 14321 may include a first circular arc segment 14321-1, a middle segment 14321-2, and a second circular arc segment 14321-3, which are connected in sequence. In some embodiments, intermediate section 14321-2 can be a straight segment, and its length s can be between 0.5mm and 1.5 mm. The first and second circular arc sections 14321-1 and 14321-3 are bent toward both sides of the middle section 14321-2, respectively. In some embodiments, the angle between a tangent to the end of the first arc segment 14321-1 and/or the second arc segment 14321-3 connected to the third longitudinal connection bar 1431 and the third longitudinal connection bar 1431 may be between 85 degrees and 95 degrees. Illustratively, in some embodiments, the included angle may be 85 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 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 between 0.3mm and 0.45mm. In some embodiments, the ratio of the length s of the middle section 14321-2 to the arc length of the first or second arc sections 14321-1, 14321-3 can be between 3 and 5. In some embodiments, the first arc segment 14321-1 and the second arc segment 14321-3 may have the same or different radii and may have the same or different arc lengths.

In some embodiments, intermediate section 14321-2 may also be a curved section, such as a circular arc. In some embodiments, the curved segment can form an S-shape, a wave shape (the wave shape can be regarded as a plurality of S-shapes, or a plurality of sinusoidal curves), and a fold line shape together with the first circular segment 14321-1 and the second circular segment 14321-3. In some embodiments, when the curved line segment can form a zigzag shape together with the first circular arc segment 14321-1 and the second circular arc segment 14321-3, in order to avoid excessive stress concentration at the bending position during the radial ring stretching process, the connection position between the zigzag segments can be set to have a smooth transition and a large bending angle, for example, in some embodiments, the bending angle can be 160 degrees to 180 degrees.

In some embodiments, the surface roughness of the constraining structure 140 may be reduced and the corrosion resistance thereof may be improved by electropolishing, but when the constraining structure 140 is processed by electropolishing, since the number of the third longitudinal connecting rods 1431 of the acting section 143 is greater than the number of the first longitudinal connecting rods 1411 connected to the proximal end 141 and/or the second longitudinal connecting rods 1421 connected to the distal end 142, the current passing through the first longitudinal connecting rods 1411 connected to the proximal end 141 and/or the second longitudinal connecting rods 1421 connected to the distal end 142 is greater than the current passing through the third longitudinal connecting rods 1431 connected to the acting section 143, so that the width loss of the polished first longitudinal connecting rods 1411 connected to the proximal end 141 and/or the second longitudinal connecting rods 1421 connected to the distal end 142 is too large, and the constraining structure 140 may have a certain safety hazard. Therefore, in order to avoid excessive loss of width of the first longitudinal tie bar 1411 connected to the proximal end 141 and/or the second longitudinal tie bar 1421 connected to the distal end 142 after polishing, in some embodiments, the width of the first longitudinal tie bar 1411 connected to the proximal end 141 and/or the second longitudinal tie bar 1421 connected to the distal end 142 can be increased before electropolishing, thereby compensating for the width of the bars lost during electrochemical polishing.

Based on this, in some embodiments, the width of at least one of the longitudinal connecting rods at the connection proximal end 141 and/or the connection distal end 142 may be greater than the width of the third longitudinal connecting rod 1431 at the active segment 143, thereby ensuring that the first longitudinal connecting rod 1411 at the connection proximal end 141 and/or the second longitudinal connecting rod 1421 at the connection distal end 142 and the third longitudinal connecting rod 1431 at the active segment 143 have widths satisfying predetermined requirements after being electropolished. It should be noted that the "width" of the longitudinal connecting rod described in the present specification may refer to a dimension perpendicular to the length extension direction of the longitudinal connecting rod.

Referring to fig. 4, in some embodiments, the first longitudinal connecting bar 1411 at the proximal connecting end 141 and the second longitudinal connecting bar 1421 at the distal connecting end 142 may be aligned or substantially parallel, and the third longitudinal connecting bar 1431 at the active segment 143 may be connected to a radial ring comprising a plurality of S-shaped structures (which may be the aforementioned connecting segments in some embodiments) to form a mesh structure wrapped around the balloon 120. Wherein, the first longitudinal connecting bar 1411 at the proximal connecting end 141 being "substantially parallel" to the second longitudinal connecting bar 1421 at the distal connecting end 142 may mean that the angle therebetween is less than or equal to 15 °.

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

bars

1411, 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 and/or second longitudinal connecting

bars

1411 and 1421 at the connection proximal end 141 and/or the connection distal end 142 and the third longitudinal connecting bar 1431 at the action section 143 have widths satisfying predetermined requirements after electropolishing, the widths of the first and/or second longitudinal connecting

bars

1411 and 1421 at the connection proximal end 141 and/or the connection distal end 142 before electropolishing may be set to be 1.5 to 4 times the width of the third longitudinal connecting bar 1431 of the action section 143.

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

bars

1411, 1421 can also be 1.5 to 3 times the width of the third longitudinal connecting bar 1431; in some embodiments, the width of the first 1411 and/or second 1421 longitudinal connecting bar may also be 2 to 3 times the width of the third 1431 longitudinal connecting bar.

In some embodiments, the width W1 of the first 1411 and/or second 1421 longitudinal tie bars at the proximal 141 and/or distal 142 ends before electropolishing may be between 0.2mm and 0.3mm, and the width W2 of the third 1431 longitudinal tie bar at the active segment 143 before electropolishing may be between 0.08mm and 0.15 mm.

It should be noted that the above relation regarding the number 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 third longitudinal connecting bars 1431 to the number of first 1411 or second 1421 longitudinal connecting bars may be less than or greater than 2, and correspondingly, the ratio of the width of the first 1411 or second 1421 longitudinal connecting bar to the width of the third longitudinal connecting bar 1431 may be less than 2 or greater than 4.

Fig. 5 is a schematic structural view of a balloon catheter assembly according to further embodiments of the present disclosure.

As shown in fig. 5, in some embodiments, the catheter 130 may include a stress diffusion tube 131, an inner tube 132, an outer tube 133 disposed over the inner tube 132, and a connecting tube 134 disposed between the outer tube and the balloon proximal end 1201. Wherein one end of the stress diffusion tube 131 is connected to the catheter hub 110, and the other end is connected to the proximal end of the outer tube 133. The distal end of outer tube 133 is attached to the proximal end of connecting tube 134, and the distal end of connecting tube 134 is attached to the proximal end 1201 of balloon 120 by adhesive 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 element. In some embodiments, the inner tube 131 may include a plurality of internal lumens, such as a guidewire lumen, a distal balloon inflation lumen, a proximal balloon inflation lumen, a drug loading lumen, for receiving a guidewire, a distal inflation gas or liquid, a proximal inflation gas or liquid, an active drug, and the like, respectively.

In some embodiments, the inner tube 131 may be fabricated from a metal or polymeric material, such as stainless steel, polyamide, polyether block amide, polyurethane, and the like. In some embodiments, the inner and/or outer walls of the inner tube 131 may include a lubricious coating, such as a polytetrafluoroethylene coating or the like, to reduce its frictional resistance.

In some embodiments, outer tube 133 may be braided using metal wires. Also, to provide for better orientation of the outer tube 133 as it enters the vascular system, in some embodiments, the wire used may be a flat wire (i.e., a wire having a flattened shape).

In some embodiments, to reduce the size of the outer tube 133, the metal wires may be stainless steel wires or nickel titanium wires, preferably flat stainless steel or nickel titanium wires with a thickness of less than 0.2mm, such as 0.1mm, 0.08mm, 0.15mm, etc., which are braided so that the inner diameter of the entire outer tube 133 is controlled to be 0.6mm to 1.2mm, and the outer diameter is correspondingly controlled to be 0.8mm to 1.4mm.

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, polytetrafluoroethylene, or the like. In some embodiments, to control the thickness of the outer and/or inner layers to less than 0.2mm, the wire may be wound directly onto the inner layer of the outer tube 133 or the wire may be co-extruded with the outer and/or inner layers.

In some embodiments, the outer tube 133 may be bonded to the stress diffusion tube 131 by an adhesive, for example, the stress diffusion tube 131 may be positioned with the outer tube 133, and then an adhesive may be added, which may be applied to create capillary action through the small space between the two, thereby sufficiently bonding the two. Exemplary adhesives may include polyimide adhesives, polytetrafluoroethylene adhesives, and the like.

In some embodiments, to enhance pushability and twistability of balloon 120, the connection of the distal end of outer tube 133 to the proximal end of balloon 120 may be via connecting tube 134 and adhesive layer 135.

In some embodiments, the distal end of the outer tube 133 may be coupled to the proximal end of the linking tube 134, and the distal end of the linking tube 134 may be coupled to the proximal end 1201 of the balloon 120 by the adhesive layer 135. In some embodiments, to minimize the outer diameter of the catheter 130, an adhesive layer 135 may be attached 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, to achieve sufficient adhesion, the adhesive layer 135 may be simultaneously adhered 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.

In some embodiments, the outer tube 133 and the balloon 120 may have different radial dimensions, and the connecting tube 134 may have a variable diameter structure to ensure that the two ends of the connecting tube 134 can be reliably connected to the proximal end 1201 of the balloon 120 and the distal end of the outer tube 133, respectively. Specifically, the dimensions of the two ends of the connecting tube 134 may be different, wherein the dimension of the end near the outer tube 133 may be the same as or close to the dimension of the outer tube 133, and the dimension of the end near the balloon proximal end 1201 may be the same as or close to the dimension of the balloon proximal end 1201.

In some embodiments, to provide for better torqueability of the balloon segments, a softer connecting tube 134 may be used to connect the outer tube 133 to the proximal end 1201 of the balloon 120. In some embodiments, the connection tube 134 and the adhesive layer 135 may be made of different soft materials.

In some embodiments, to facilitate bonding, the bonding layer 135 may be a material with a relatively low melting point. In some embodiments, the bonding layer 135 may be a material having a melting point lower than that of the connection tube 134.

In some embodiments, the connection tube 134 may be made of nylon or polyether block Polyamide (PEBAX) material, and the adhesive layer 135 may be made of polyether block amide (PEBA) material.

In some embodiments, considering that the soft material may increase the torsion performance, but also may cause the pushing performance to be deteriorated, by providing the adhesive layer 135 at the connection tube 134, on one hand, the connection tube 134 made of the soft material may be slightly thickened to increase the toughness, and on the other hand, due to the low melting point of the material used for the adhesive layer 135, the material may be rapidly melted when heated, so as to firmly connect the distal end of the outer tube 133 and the proximal end 1201 of the balloon.

Fig. 6 is a schematic view of an adhesive layer of a balloon catheter assembly of some embodiments of the present description.

Referring to fig. 6, in some embodiments, in order to achieve sufficient adhesion of the adhesive layer 135 to the connecting tube 134 and the proximal end 1201 of the balloon, the adhesive layer 135 may be provided in an L-shaped cross-section configuration. Specifically, the adhesive layer 135 may include a first connection portion 135-1 and a second connection portion 135-2, wherein the first connection portion 135-1 has a thickness greater than that of the second connection portion 135-2, the first connection portion 135-1 may be connected to both a section of the distal end of the connection tube 134 and the inner surface of the proximal end 1201 of the balloon, and the second connection portion 135-2 may be connected to the outer surface of the connection tube 134. It should be noted that, the bonding layer 135 with an L-shaped cross section is used to connect the proximal end 1201 of the balloon and the catheter 134, so that the connection area between the two is increased, and the connection relationship between the two is more reliable.

In some embodiments, the adhesive layer 135 may be thermally welded by using a laser, heat radiating metal jaws, RF energy, or other methods. In some embodiments, the thermal welding temperature may be controlled in a plurality of ramp-up phases: in the first stage, the welding temperature is raised to 100-110 ℃ for 20-30 s, so that the bonding layer 135 is softened; in the second stage, the welding temperature is raised to 150 ℃ to 160 ℃ for 80s to 100s, and the bonding layer 135 is fully welded.

In some embodiments, it has been found through experiments that when the length of the connection tube 134 is too long (e.g., greater than 15 mm), the pushing force cannot be transmitted, thereby resulting in poor pushing performance, and when the length of the connection tube 134 is too short (e.g., less than 8 mm), the twisting performance is poor due to the close distance of the plurality of welding points.

Based on the above test results, in some embodiments, in order to ensure the combination of the torsion performance and the pushing performance of the balloon segment, the length of the connection tube 134 may be controlled between 8mm and 15mm. Alternatively, in some embodiments, the length of the connection tube 134 may be 8mm to 10mm; in some embodiments, the length of the connection tube 134 may be 10mm to 15mm; in some embodiments, the length of the connection tube 134 may be 9mm to 12mm.

In some embodiments, it is contemplated that the torsional and pushing properties of the balloon segment may also be related to the thickness of the connecting tube 134, whether the adhesive layer 135 is added, and the thickness of the adhesive layer 135, among other factors. In order to ensure the comprehensive torsion performance and pushing performance of the balloon segment, in some embodiments, an adhesive layer 135 may be disposed at the joint of the connecting tube 134 and the proximal end 1201 of the balloon, and the thickness of the adhesive layer 135 may be controlled to be between 0.1mm and 0.2mm, and the thickness of the connecting tube 134 may be controlled to be between 0.1mm and 0.2mm.

In order to verify the above feasibility regarding the thickness of the adhesive layer 135 and the thickness of the connection pipe 134, the applicant carried out corresponding tests. Exemplary test results are shown in the following table:

as can be seen from the above table, when the adhesive layer 135 is disposed at the joint between the connection tube 134 and the proximal end 1201 of the balloon, the thickness of the adhesive layer 135 is controlled to be 0.1mm to 0.2mm, and the thickness of the connection tube 134 is controlled to be 0.1mm to 0.2mm, the balloon catheter assembly 100 has a larger maximum pushing force and a better over-bending capability (i.e., has better torsion performance and pushing performance). Illustratively, in some embodiments, the thickness of the connection tube 134 may be set to 0.1mm, and the thickness of the adhesive layer 135 may be set to 0.2mm; in some embodiments, the thickness of the connection tube 134 may be set to 0.2mm, and the thickness of the adhesive layer 135 may be set to 0.1mm.

In some embodiments, to accommodate peripheral requirements, the balloon 120 may be 20mm to 40mm in length and 5mm to 16mm in diameter. Alternatively, in some embodiments, balloon 120 may be 20mm to 30mm in length and 5mm to 10mm in diameter; in some embodiments, balloon 120 may have a length of 25mm to 35mm and a diameter of 8mm to 12mm.

In some embodiments, balloon 120 may be a single-layer balloon made of nylon or nylon copolymer, or parylene, or may be a double-layer balloon with an inner layer made of parylene and an outer layer made of nylon. It should be noted that, during the use process, the constraining structure 140 may have a sharp tip due to local fatigue fracture, and once the sharp tip pierces the balloon, the balloon is easily pierced, so in some embodiments, by configuring the balloon 120 as a double-layer balloon with an inner layer made of poly-p-phthalic plastic and an outer layer made of nylon, the material can be selected and matched in terms of cost, weight and puncture-proof performance, thereby enhancing the safety of the balloon.

In some embodiments, constraining structure 140 may be a memory alloy stent formed by integral cutting (e.g., laser integral cutting), exemplary memory alloys may include nitinol, copper-nickel based alloys, and the like. Referring to fig. 2, 4 and 5, in some embodiments, the memory metal stent may include a plurality of wires, which may be divided into a first longitudinal connecting rod 1411 at the proximal end 141, a second longitudinal connecting rod 1421 at the distal end 142, a third longitudinal connecting rod 1431 at the active segment 143, and a radial ring including a plurality of S-shaped structures (which may be the aforementioned connecting segments in some embodiments) criss-crossed with the first longitudinal connecting rod 1411 at the proximal end/the second longitudinal connecting rod 1421 at the distal end/the third longitudinal connecting rod 1431 at the active segment, according to the positions or shapes.

In some embodiments, the plurality of S-shaped structures may be arranged in an array along the arrangement direction of the balloon 120. Wherein each row constitutes a wave-shaped radial ring, each of which can be connected to at least one of a first longitudinal connecting bar 1411 at the proximal end of the connection, a second longitudinal connecting bar 1421 at the distal end of the connection, and a third longitudinal connecting bar 1431 at the active segment. In some embodiments, the plurality of radial rings may be equally spaced apart in order to allow the constraining structure 140 to have substantially the same constraining force on the balloon 120 at different locations.

The radial loops of the S-shaped structure can expand or contract with the balloon 120 to limit the size and shape of the balloon 120, in other words, the radial loops of the S-shaped structure can match the longitudinal and radial expansion of the balloon 120 during inflation and can maintain the balloon 120 at a desired position during inflation.

In some embodiments, the radial loop of the S-shaped structure has a total length that is less than the maximum circumference of the balloon 120 after expansion following inflation of the balloon 120. In some embodiments, to provide for the radial rings to have substantially the same constraining effect on balloon 120, different radial rings may be configured to have substantially the same contraction performance and circumference.

In some embodiments, at least one rounded bumper segment can be formed in the memory metal stent at least one junction 1437 of each wire. Specifically, the connection intersection point of any two metal wires in the memory metal stent forms a fillet or circular arc structure during cutting, so that the problem that the stent is broken in the expansion or contraction process due to over concentrated stress at the connection intersection point 1437 of each metal wire, and further serious injury to a blood vessel is possibly caused is avoided. In addition, by setting the connection intersection 1437 to a rounded corner or a circular arc, it is possible to prevent the balloon 120 from being damaged due to an excessively sharp force applied to the balloon 120, compared to a sharp corner structure such as an acute corner or a right corner.

Referring to fig. 7, in some embodiments, the rounded or radiused configuration formed by the connecting intersections of the wires when cut may be an arc of a circle having a radius of curvature R1, which may be concave or convex relative to the connecting intersections. In some embodiments, the radius of curvature R1 corresponding to the fillet or the circular arc-shaped structure may be between 0.5mm and 1mm, where the radius of curvature R1 corresponding to the fillet or the circular arc-shaped structure at each connection intersection may be the same or different, and the arc length corresponding to the fillet or the circular arc-shaped structure at each connection intersection may also be the same or different.

In some embodiments, the proximal connection end 141 of the constraining structure 140 may be connected at the proximal end of the adhesive layer 135 (e.g., the second connection portion 135-2) or the proximal end 1201 of the balloon. In some embodiments, by attaching the proximal connecting end 141 of the constraining structure 140 at the proximal end (e.g., the second connecting portion 135-2) of the adhesive layer 135, the proximal connecting end 141 of the constraining structure 140 can be prevented from expanding with the balloon, thereby achieving a better constraining effect, as compared to attaching at the proximal end 1201 of the balloon, and the overall outer diameter of the catheter 130 can be reduced to some extent as compared to attaching at the proximal end 1201 of the balloon.

The coupling distal end 142 of constraining structure 140 may be coupled to the distal end of balloon 120, where the distal end of balloon 120 may refer to the location of balloon 120 that is farthest from catheter hub 110. In some embodiments, the distal connecting end 142 of the constraining structure 140 may be fixedly connected to the distal end of the balloon 120 by bonding or clipping, and similarly, the proximal connecting end 141 of the constraining structure 140 may be fixedly connected to the proximal end of the bonding layer 135 or the proximal end 1201 of the balloon by bonding or clipping.

Referring to fig. 8, in some embodiments, the cross-section of the wire in the constraining structure 140, which may refer to a section perpendicular to the direction of extension of the length of the wire, may be one or more of trapezoidal (as shown in fig. 8A), triangular (as shown in fig. 8B), or circular (as shown in fig. 8C). In some embodiments, the radial dimension of the wires in the constraining structure 140 may be 0.1mm-0.2mm. It should be noted that the shape of the cross section of the wire is merely an exemplary illustration, and in the embodiment of the present specification, the shape of the cross section of the wire may be, but is not limited to, the trapezoid, the triangle, and the circle. For example, in some embodiments, the cross-sectional shape of the wire may also be rectangular.

In some embodiments, the outer surface of balloon 120 may be used to coat a drug. In some embodiments, the drug may be applied to the outer surface of the balloon 120 in a single application. In other embodiments, an opening communicating with the drug-loading cavity inside the catheter 130 may be opened between two adjacent balloons 120, and the drug may also be delivered through the drug-loading cavity provided in the catheter 130 and delivered to the outer surface of the balloon 120 and/or the outer surface of the constraint structure 140 through the opening opened between two adjacent balloons, or directly dissolved in the blood vessel. In some embodiments, the balloon catheter assembly 100 may further include a visualization component, and the drug may be precisely administered to the target location to be treated at a fixed point according to the intravascular image obtained by the visualization component, so as to improve the therapeutic effect of the drug on the inner wall of the blood vessel to some extent.

In some embodiments, to improve the passage of the constraining structure 140, a wire with a trapezoidal cross-section may be used for the constraining structure 140, and the lower surface 810 of the wire with a trapezoidal cross-section faces outward (i.e., away from the balloon 120), or a wire with a triangular cross-section may be used, and the longest of the three sides (e.g., 821) faces outward (i.e., away from the balloon 120). Considering that when the cross-sectional shape of the metal wire is a triangle, the force applied to the balloon 120 by the side of the metal wire facing the balloon 120 may be relatively sharp (i.e. the force per unit area is relatively large), and therefore, in order to avoid the balloon being damaged by the too sharp force generated by the metal wire during the inflation process, in some embodiments, the area of the side of the metal wire facing the balloon 120 and contacting the balloon 120 may be increased, for example, the angle of one corner of the triangle facing the balloon 120 may be increased to form an obtuse angle larger than 120 °, so that the contact area of the metal wire with the balloon 120 during the inflation process may be increased, and the force applied to the balloon per unit area may be reduced. In some embodiments, the outer surface of the constraining structure may be provided with a drug coating. In some embodiments, the drug coating may be disposed only on the outer surface of the balloon and not on the outer surface of the constraining structure, since the balloon, when disposed on the outer surface of the constraining structure, may cause the wire portion of the constraining structure to form a depression with respect to the balloon during expansion, and may not contact the inner wall of the blood vessel, thereby preventing drug release.

In some embodiments, the drug coating on the outer surface of the balloon may comprise at least one other active drug in addition to the macrolide drug, for example at least one selected from the group consisting of paclitaxel and derivatives thereof, rapamycin and derivatives thereof, phosphodiesterase inhibitors, thrombin inhibitors, thymidine kinase inhibitors, antibiotics, adenosine. It should be noted that the above drugs are only exemplary, and in the embodiments of the present specification, the drug coating on the outer surface may be, but is not limited to, the aforementioned drugs.

Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing detailed disclosure is to be regarded as illustrative only and not as limiting the present specification. Various modifications, improvements and adaptations to the present description may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present specification and thus fall within the spirit and scope of the exemplary embodiments of the present specification.

Also, the description uses specific words to describe embodiments of the description. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the specification is included. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, some features, structures, or characteristics of one or more embodiments of the specification may be combined as appropriate.

Similarly, it should be noted that in the foregoing description of embodiments of the present specification, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to imply that more features are required than are expressly recited in the claims. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.

Numerals describing the number of components, attributes, etc. are used in some embodiments, it being understood that such numerals used in the description of the embodiments are modified in some instances by the use of the modifier "about", "approximately" or "substantially". Unless otherwise indicated, "about", "approximately" or "substantially" indicates that the number allows a variation of ± 20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximations that may vary depending upon the desired properties of the individual embodiments. In some embodiments, the numerical parameter should take into account the specified significant digits and employ a general digit preserving approach. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the range are approximations, in the specific examples, such numerical values are set forth as precisely as possible within the scope of the application.

For each patent, patent application publication, and other material, such as articles, books, specifications, publications, documents, etc., cited in this specification, the entire contents of each are hereby incorporated by reference into this specification. Except where the application is filed in a manner inconsistent or contrary to the present specification, and except where a claim is filed in a manner limited to the broadest scope of the application (whether present or later appended to the specification). It is to be understood that the descriptions, definitions and/or uses of terms in the accompanying materials of this specification shall control if they are inconsistent or contrary to the descriptions and/or uses of terms in this specification.

Finally, it should be understood that the embodiments described herein are merely illustrative of the principles of the embodiments described herein. Other variations are also possible within the scope of the present description. Thus, by way of example, and not limitation, alternative configurations of the embodiments of the specification can be considered consistent with the teachings of the specification. Accordingly, the embodiments of the present description are not limited to only those explicitly described and depicted herein.

Claims

1. The utility model provides a sacculus catheter assembly, includes pipe seat, sacculus and connects the pipe seat with between the sacculus, sacculus outside parcel restraint structure, restraint structure is including connecting the near-end, connecting the distal end and connecting connect the near-end, connect the effect section between the distal end, its characterized in that, the effect section includes two piece at least longitudinal tie rods and passes through two piece at least radial rings that two at least longitudinal tie rods connect, what each connection section on the radial ring connected gradually includes first circular arc section, interlude and second circular arc section.

2. The assembly of claim 1, wherein an included angle of 85 degrees to 95 degrees is formed between a tangent of an end of the first arc segment and/or the second arc segment and a longitudinal direction of the longitudinal connecting rod.

3. The assembly of claim 1, wherein the radius of curvature of the first arc segment and/or the second arc segment is between 0.3mm and 0.45mm, and the ratio of the length of the intermediate segment to the arc length of the first arc segment or the second arc segment is between 3 and 5.

4. The assembly of claim 1, wherein a portion of the at least two longitudinal connecting rods between two adjacent radial rings is at least one undulation.

5. The assembly of claim 1, wherein the intermediate section is a straight section.

6. The assembly of claim 1, wherein the catheter comprises an inner tube, an outer tube sleeved outside the inner tube, and a connecting tube disposed between the outer tube and the balloon, wherein a distal end of the outer tube is connected to the connecting tube, and an inner surface of the connecting tube is connected to a proximal end of the balloon through an adhesive layer.

7. The assembly of claim 6, wherein the connecting tube is made of nylon or polyether block polyamide and the adhesive layer is made of polyether block amide.

8. An assembly according to claim 6 or 7, characterised in that the length of the connecting tube is 8-15 mm.

9. The assembly of claim 1, wherein each connection point on the radial ring between the longitudinal connecting rod and the radial ring forms at least one radiused buffer segment.

10. The assembly of claim 6, wherein the proximal attachment end of the constraining structure is attached to a proximal end of the adhesive layer.