A method for preparing a spinous process balloon and a spinous process balloon catheter

Abstract

This application relates to the field of medical device technology, specifically to a method for preparing a spinous process balloon and a spinous process balloon catheter. The method for preparing a spinous process balloon provided by this invention includes the following steps: preparing two equilateral triangular heat-shrink tubings of different sizes; inserting a circular sleeve into the equilateral triangular heat-shrink tubing; positioning three spinous process wires with equilateral triangular cross-sections between the circular sleeve and the equilateral triangular heat-shrink tubing, and laser welding them so that the circular sleeve is welded to both ends of the spinous process wire; dividing the balloon into flaps, placing the spinous process wires within the flaps, so that the circular sleeve located at the distal end is fitted onto the distal tip of the balloon, and the circular sleeve located at the proximal end is fitted onto the outer tube of the proximal end of the balloon; fitting circular heat-shrink tubing onto the circular sleeves located at the proximal and distal ends respectively, and laser welding them so that the circular sleeve is welded to the proximal and distal ends of the balloon respectively; and finally, curling and folding the balloon flaps and fitting a protective sleeve. This effectively ensures the uniform distribution of the spinous process wires on the spinous process balloon.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a method for preparing a spinous process balloon and a spinous process balloon catheter. Background Technology

[0002] The spinous balloon, a device used for coronary intervention, mainly consists of a balloon and three specially made nylon spinous filaments attached to the surface of the balloon. The three spinous filaments are spaced 120° apart and are only connected to the head and tail ends of the balloon.

[0003] The spinous process balloon is small in size and has good retraction properties. It can be embedded in the calcified area with a cone-shaped structure, expand multiple times at the calcification site, and can be safely withdrawn after full expansion. Compared with ordinary balloons and cutting balloons, it causes less damage to the blood vessel wall.

[0004] The distribution angle of the spinous filaments around the balloon is particularly important. When there is a deviation, the inflation force applied by the balloon cannot be effectively transmitted to the lesion site through the spinous filaments. In the current manufacturing process of spinous balloons, the 120° interval angle of the spinous filaments on the balloon cannot be well guaranteed. Summary of the Invention

[0005] The purpose of this application is to provide a method for preparing a spinous process balloon and a spinous process balloon catheter. This preparation method can reliably ensure that the spinous process filaments are distributed at 120° around the periphery of the balloon, thereby improving the product quality of the prepared spinous process balloon.

[0006] To achieve the above objectives, in a first aspect, the present invention provides a method for preparing a spinous process sac, comprising the following steps:

[0007] Prepare two equilateral triangular heat shrink tubes of different sizes, and insert a circular sleeve inside the equilateral triangular heat shrink tube;

[0008] Three equilateral triangular cross-section ratchet wires are positioned between the circular sleeve and the equilateral triangular heat shrink tubing, and laser welded so that the circular sleeve is welded to both ends of the ratchet wires respectively.

[0009] The balloon is divided into flaps, and the spinous filaments are placed inside the balloon flaps. The circular cannula at the distal end is fitted onto the tip of the distal end of the balloon, and the circular cannula at the proximal end is fitted onto the outer tube of the proximal end of the balloon.

[0010] Circular heat-shrink tubing was fitted onto the circular cannulas located at the proximal and distal ends of the balloon, respectively, and then laser-welded to the proximal and distal ends of the balloon.

[0011] After curling and folding the balloon flap, put on the protective cover.

[0012] In an optional embodiment, the equilateral triangular heat shrink tubing and the circular sleeve each comprise two pairs, which are disposed opposite to each other at both ends of the spinous filament, respectively corresponding to the proximal and distal ends of the spinous sac.

[0013] In an optional embodiment, the circular sleeve is tangent to the equilateral triangular heat shrink tubing, and the size of the equilateral triangular heat shrink tubing and the circular sleeve located at the near end is larger than the size of the equilateral triangular heat shrink tubing and the circular sleeve located at the far end.

[0014] In an optional embodiment, the three apex angles of the spiny filament abut against the apex angle of the equilateral triangular heat shrink tubing, and the straight side of the spiny filament corresponding to the abutment apex angle is tangent to the outer wall of the circular sleeve.

[0015] In an optional embodiment, after laser welding, the circular sleeve and the spiked wire are welded into a single structure, and the equilateral triangular heat shrink tubing is removed from the circular sleeve after welding.

[0016] In an optional embodiment, before fitting the proximal circular sleeve onto the outer tube, a slit is made in the circular sleeve, the slit extending through the length of the circular sleeve and positioned between the two spiny filaments, so that the outer tube can be secured into the circular sleeve through the slit.

[0017] In an optional embodiment, after laser welding, the circular sleeve is welded to the outer tube and the tip to form an integral structure, and the circular heat shrink tubing is removed from the circular sleeve after welding.

[0018] In an optional embodiment, the equilateral triangular heat shrink tubing is prepared on a mandrel, which includes a triangular prism-shaped stepped mandrel. The two equilateral triangular heat shrink tubing are respectively fitted onto the thick end and the thin end of the triangular prism-shaped stepped mandrel, and the preparation is completed by rotational heating under a hot air welding machine.

[0019] In an optional embodiment, the welding of the spindle wire to the circular sleeve, and the welding of the circular sleeve to the outer tube and the tip, are both performed on the mandrel.

[0020] When the spindle wire is welded to the circular sleeve, the mandrel includes a cylindrical stepped mandrel that is simultaneously inserted into the two circular sleeves.

[0021] When the circular sleeve is welded to the outer tube and the tip respectively, the mandrel includes a cylindrical mandrel that is separately inserted into the cavity between the tip and the inner and outer tubes of the proximal end of the balloon.

[0022] Secondly, the present invention provides a spinous process balloon catheter, comprising a spinous process balloon prepared according to the spinous process balloon preparation method described in any of the foregoing embodiments, and a proximal catheter assembly, wherein the proximal catheter assembly and the spinous process balloon are assembled into an integral structure by hot air welding.

[0023] By using the combination of the equilateral triangular heat shrink tubing and the circular sleeve, the equilateral triangular spindle filaments can be positioned and bound in the gap between the circular sleeve and the equilateral triangular heat shrink tubing. This facilitates the even distribution of the three spindle filaments on the circumference of the circular sleeve, ensuring a good 120° interval angle between the three spindle filaments on the circumference of the balloon.

[0024] Under the constraint of the equilateral triangular heat shrink tubing, the circular sleeve can be welded to both ends of the circumferentially distributed spinous filaments, thereby forming a spinous process combination structure around the spinous process sac.

[0025] By connecting the two ends of the spinous process assembly structure to the proximal and distal ends of the balloon respectively, it can be welded together to form an integral structure of the spinous process balloon, effectively ensuring the uniform distribution of the spinous process filaments on the spinous process balloon.

[0026] By segmenting the balloon and placing the spinous filaments within the balloon flaps, the uniform distribution of the spinous filaments on the balloon is further ensured, enhancing the pushing force exerted by the balloon on the outer edge of the spinous filaments after expansion, thus ensuring the therapeutic effect of the spinous balloon on vascular lesions.

[0027] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0028] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the structure of an equilateral triangular heat shrink tubing after it has been shaped on a mandrel.

[0030] Figure 2 This is a schematic diagram showing the fit between an equilateral triangular heat shrink tubing and a circular sleeve.

[0031] Figure 3 This is a schematic diagram showing the fit between the spiny filament, the circular sleeve, and the equilateral triangular heat shrink tubing.

[0032] Figure 4 for Figure 3 A schematic diagram of the cross-sectional structure.

[0033] icon:

[0034] 1-Equilateral triangular heat shrink tubing;

[0035] 2- Circular sleeve;

[0036] 3-Spinous filaments. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0038] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0039] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "setup" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0040] See Figures 1-4 The method for preparing the spinous process balloon in this application is mainly used in the processing and preparation of the spinous process balloon. Specifically, the spinous process filaments 3 are first evenly distributed and positioned on the circumferential direction of the circular sleeve 2 through the equilateral triangular heat shrink tube 1, so that the two ends of the spinous process filaments 3 are respectively welded to the two circular sleeves 2. Then, the spinous process combination structure composed of the spinous process filaments 3 and the circular sleeves 2 is welded onto the balloon to assemble the overall structure of the spinous process balloon.

[0041] By positioning the spinous filaments 3, the two ends of the three spinous filaments 3 are evenly distributed circumferentially on the proximal and distal circular sheaths 2, respectively, ensuring that the three spinous filaments 3 are spaced 120° apart in the circumferential direction of the balloon.

[0042] By combining balloon flap segmentation with placement of the spinous filament 3 within the flaps, the spinous filament 3 can be positioned within the balloon body, enhancing its installation stability. Furthermore, the uniform circumferential distribution of the spinous filament 3 effectively converts the expansion force generated after balloon inflation into a driving force for the spinous filament 3, ensuring the therapeutic effect of the outer edge of the spinous filament 3 on the vascular lesion site.

[0043] The preparation method of the spinous process balloon in this invention mainly includes the following steps, specifically divided into welding of the spinous process assembly structure and welding of it to the balloon body.

[0044] During the welding process of the spiny assembly structure, it is first necessary to prepare heat shrink tubing for positioning and binding the spiny wire 3 around the periphery of the proximal circular sleeve 2 and the distal circular sleeve 2. The positioning and binding of the spiny wire 3 is mainly achieved through an equilateral triangular heat shrink tubing 1 with the same outline shape as the spiny wire 3 but a different proportion.

[0045] Specifically, the cross-sectional shape of the spiny filament 3 and the cross-sectional shape of the equilateral triangular heat shrink tube 1 are both equilateral triangles, which can make any vertex of the spiny filament 3 abut against the interior angle of the equilateral triangular heat shrink tube 1, and make the entire spiny filament 3 abut against the interior angle of the equilateral triangular heat shrink tube 1.

[0046] The fabrication of the equilateral triangular heat shrink tubing 1 is mainly carried out on a mandrel, primarily through the shaping of circular heat shrink tubing. Specifically, two circular heat shrink tubings are respectively fitted onto a triangular prism-shaped stepped mandrel. Preferably, the two heat shrink tubings are fitted onto the thicker and thinner ends of the triangular prism-shaped stepped mandrel, respectively. A hot air welding machine is used for rotational heating, causing the two heat shrink tubings to be shaped on the triangular prism-shaped stepped mandrel, resulting in two equilateral triangular heat shrink tubing 1s of different sizes but identical cross-sectional shapes. The two formed equilateral triangular heat shrink tubing 1s are then demolded from the mandrel and are ready for subsequent fabrication processes.

[0047] Based on the three spiny filaments 3 and the equilateral triangle cross-sectional structure in this application, the apex of the three spiny filaments 3 needs to abut against the three inner corners of the equilateral triangle heat shrink tube 1, and the walls on both sides of the apex of the spiny filaments 3 need to be effectively fitted with the inner wall of the equilateral triangle heat shrink tube 1.

[0048] By attaching the equilateral triangular heat shrink tubing 1 to the outside of the circular sleeve 2, and positioning the two ends of the three serrated threads 3 in the gap between the circular sleeve 2 and the equilateral triangular heat shrink tubing 1, the serrated threads 3 can be evenly distributed on the circumferential periphery of the circular sleeve 2.

[0049] In this invention, the equilateral triangular heat shrink tubing 1 and the circular sleeve each comprise two pairs, arranged opposite each other at both ends of the spinous filament 3, corresponding to the proximal and distal ends of the spinous sac, respectively. Specifically, the circular sleeve 2 is concentrically arranged with the equilateral triangular heat shrink tubing 1, and the circular sleeve 2 needs to be tangent to the equilateral triangular heat shrink tubing 1.

[0050] To ensure that the circular sleeves 2 at both ends of the spinous filament 3 match the proximal and distal dimensions of the balloon, the dimensions of the equilateral triangular heat-shrink tubing 1 and the circular sleeve 2 at the proximal end are larger than those at the distal end. This allows the two ends of the spinous process assembly structure to fit the proximal and distal ends of the balloon, respectively, ensuring that the spinous filament 3 is evenly distributed around the circular sleeves 2, thus enhancing the structural harmony of the prepared spinous balloon structure.

[0051] Based on the aforementioned arrangement where the three apexes of the spiked wire 3 abut against the apexes of the equilateral triangular heat shrink tubing 1, specifically against the interior angles of the equilateral triangular heat shrink tubing 1, and considering the tangent arrangement of the circular sleeve 2 and the equilateral triangular heat shrink tubing 1, it is also necessary to ensure that the straight edge corresponding to the abutment of the spiked wire 3 is tangent to the outer wall of the circular sleeve 2. This arrangement allows the spiked wire 3 to be stably and reliably installed in the space between the circular sleeve 2 and the equilateral triangular heat shrink tubing 1, preventing the spiked wire 3 from shifting or moving within the installation space due to extra clearance, and ensuring the reliable and evenly distributed positioning of the spiked wire 3 around the circular sleeve 2.

[0052] In this invention, both the circular sleeve 2 and the equilateral triangular heat shrink tube 1 are tube segments of a certain length. Preferably, the length of the equilateral triangular heat shrink tube 1 is greater than the length of the circular sleeve 2. At least a portion of the end of the thorn 3 can overlap the outer wall of the circular sleeve 2, so that the equilateral triangular heat shrink tube 1 can form an effective outer wrap around the circular sleeve 2 and the end of the thorn 3, ensuring that the circular sleeve 2 and the thorn 3 at both ends of the thorn 3 are fully welded.

[0053] After binding and installing three spiked wires 3 between two pairs of circular sleeves 2 and equilateral triangular heat shrink tubing 1, and positioning the two ends of the spiked wires 3 to overlap in the installation space between the circular sleeves 2 and the equilateral triangular heat shrink tubing 1, laser welding of the spiked assembly structure is performed. After laser welding, the circular sleeves 2 and the spiked wires 3 are welded into a single structure. After welding, the equilateral triangular heat shrink tubing 1 is torn off and removed from the circular sleeves 2, resulting in a spiked assembly structure in which the spiked wires 3 are evenly distributed on the circular sleeves 2. The spiked assembly structure specifically includes a spatial frame structure composed of three spiked wires 3 and circular sleeves 2 at both the proximal and distal ends, so as to facilitate the assembly and connection of the balloon in the internal space of the spatial frame structure.

[0054] In order to reliably install the spinous process assembly structure on the balloon, the balloon needs to be segmented before connecting the spinous process assembly structure to the balloon. Specifically, the balloon body needs to be evenly divided into three balloon segments, and folds are set between adjacent balloon segments so that the three spinous process filaments 3 are respectively housed in the folds, so that the three spinous process filaments 3 correspond to the folds between the three balloon segments.

[0055] During the process of welding the spinous process assembly structure onto the balloon body, the main steps are to insert the distal tip of the balloon into the smaller distal circular tube 2, and to clamp the proximal outer tube of the balloon into the larger proximal circular tube 2. Laser welding is then used to fuse the proximal and distal circular tubes 2 with the outer tube and the tip, respectively.

[0056] Before attaching the proximal circular cannula 2 to the outer tube, an incision is made in the proximal circular cannula 2. Specifically, the incision extends through the entire length of the proximal circular cannula 2, allowing the proximal circular cannula 2 to be opened by external force, and the outer tube of the balloon at the proximal end to be secured into the proximal circular cannula 2 through the incision.

[0057] Furthermore, in order to reduce the impact on the spinous filaments 3 and prevent the incision from damaging the structural strength of the spinous assembly structure after the spinous filaments 3 are positioned, the incision is set between any two spinous filaments 3. Preferably, it is set at the center of the two spinous filaments 3 on the proximal circular sleeve 2, which reduces the interference with the overall structural strength.

[0058] It should be noted that the incision in this invention is only to facilitate the fitting of the proximal circular cannula 2 with the proximal outer tube of the balloon. The incision can be closed and restored during the laser welding process, and integrated with the proximal outer tube of the balloon, without affecting the overall structure of the spinous process balloon.

[0059] After the incision is completed, laser welding is performed by inserting the tip of the distal end of the balloon into the smaller distal circular cannula 2, and clamping the outer tube of the proximal end of the balloon onto the larger proximal circular cannula 2. Then, two circular heat shrink tubes are respectively fitted onto the circular cannsula 2 on both sides of the balloon and laser welding is performed.

[0060] The circular heat shrink tubing serves two purposes: firstly, to secure the connection between the two circular sleeves 2 on both sides and the balloon tip and outer tube before welding; and secondly, to facilitate the fusion welding between the balloon body and the circular sleeves 2.

[0061] After laser welding, the proximal and distal circular sleeves 2 are welded to the outer tube and the tip to form an integral structure. After welding, the circular heat shrink tube is torn off from the circular sleeve 2 to obtain the overall structure of the assembled spinous process balloon.

[0062] In this invention, the two laser welding processes are also completed through a mandrel. Specifically, the welding of the spindle wire 3 to the circular sleeve 2, and the welding of the circular sleeve 2 to the outer tube and the tip, are all performed on the mandrel.

[0063] When the two ends of the spindle wire 3 are welded to the proximal and distal circular sleeves 2 respectively, the two circular sleeves 2 are simultaneously fitted onto the cylindrical stepped mandrel. Specifically, the thicker end of the cylindrical stepped mandrel is inserted into the proximal circular sleeve 2, and the thinner end is inserted into the distal circular sleeve 2. After the welding of the spindle wire 3 to the circular sleeves 2 is completed, the equilateral triangular heat shrink tubing 1 is peeled off from the mandrel.

[0064] When the proximal and distal circular sheaths 2 are welded to the outer tube and tip respectively, two separately configured cylindrical mandrels of different sizes are inserted into the inner and outer tube cavities of the distal tip and proximal end of the balloon, respectively. After the balloon body and the circular sheaths 2 are welded together, the circular heat-shrink tubing is peeled off and removed from the mandrels.

[0065] By performing laser welding on the mandrel, stable and regular molded products can be provided, ensuring the quality of the molded products.

[0066] After completing the welding connection between the balloon body and the spinous process assembly structure, the balloon flap is rolled and folded and covered with a protective sleeve to obtain the formed product of the spinous process balloon.

[0067] In one specific preparation process, the length of the equilateral triangular heat shrink tubing 1 is 15mm, which can effectively wrap the spiny filament 3 and the circular sleeve 2. The length of the proximal circular sleeve 2 is 5mm, the length of the distal circular sleeve 2 is 3.5mm, and the height of the spiny filament 3 is 0.2-1mm, which can ensure the structural stability of the spiny assembly structure.

[0068] The method for preparing the spinous process balloon in this invention can effectively improve the distribution of the spinous process filaments 3 around the balloon, and reliably ensure that the spinous process filaments 3 are evenly spaced around the balloon.

[0069] The present invention also provides a spinous process balloon catheter, comprising a spinous process balloon prepared according to the above-described method for preparing a spinous process balloon, and a proximal catheter assembly, wherein the proximal catheter assembly and the spinous process balloon are assembled into an integral structure by hot air welding.

[0070] The spike balloon catheter, assembled by hot air welding, effectively improves the quality of existing products and ensures the therapeutic effect on vascular lesions.

[0071] It should be noted that, where there is no conflict, the features in the embodiments of this application can be combined with each other.

[0072] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A method for preparing a spinous process sac, characterized in that, Includes the following steps: Prepare two equilateral triangular heat shrink tubes of different sizes, and insert a circular sleeve inside the equilateral triangular heat shrink tube; Three equilateral triangular cross-section ratchet wires are positioned between the circular sleeve and the equilateral triangular heat shrink tubing, and laser welded so that the circular sleeve is welded to both ends of the ratchet wires respectively. The balloon is divided into flaps, and the spinous filaments are placed inside the balloon flaps. The circular cannula at the distal end is fitted onto the tip of the distal end of the balloon, and the circular cannula at the proximal end is fitted onto the outer tube of the proximal end of the balloon. Circular heat-shrink tubing was fitted onto the circular cannulas located at the proximal and distal ends of the balloon, respectively, and then laser-welded to the proximal and distal ends of the balloon. After curling and folding the balloon flap, put on the protective cover.

2. The method for preparing the spinous process sac according to claim 1, characterized in that, The equilateral triangular heat shrink tubing and the circular sleeve each comprise two pairs, arranged opposite each other at both ends of the spinous filament, corresponding to the proximal and distal ends of the spinous sac, respectively.

3. The method for preparing the spinous process balloon according to claim 2, characterized in that, The circular sleeve is tangent to the equilateral triangular heat shrink tubing, and the size of the equilateral triangular heat shrink tubing and the circular sleeve located at the near end is larger than the size of the equilateral triangular heat shrink tubing and the circular sleeve located at the far end.

4. The method for preparing the spinous process sac according to claim 2, characterized in that, The three apex angles of the spiny filament abut against the apex angle of the equilateral triangular heat shrink tubing, and the straight side of the spiny filament corresponding to the abutment apex angle is tangent to the outer wall of the circular sleeve.

5. The method for preparing the spinous process sac according to claim 1, characterized in that, After laser welding, the circular sleeve and the spiked wire are welded into a single structure, and the equilateral triangular heat shrink tubing is removed from the circular sleeve after welding.

6. The method for preparing the spinous process sac according to claim 5, characterized in that, Before attaching the proximal circular sleeve to the outer tube, the process further includes making a cut in the circular sleeve, the cut extending through the length of the circular sleeve and positioned between the two spiny filaments, so as to facilitate the outer tube being snapped into the circular sleeve through the cut.

7. The method for preparing the spinous process sac according to claim 5, characterized in that, After laser welding, the circular sleeve is welded to the outer tube and the tip to form an integral structure, and the circular heat shrink tubing is removed from the circular sleeve after welding.

8. The method for preparing the spinous process sac according to claim 1, characterized in that, The equilateral triangular heat shrink tubing is prepared on a mandrel, which includes a triangular prism-shaped stepped mandrel. The two equilateral triangular heat shrink tubing are respectively fitted onto the thick end and the thin end of the triangular prism-shaped stepped mandrel, and the preparation is completed by rotational heating under a hot air welding machine.

9. The method for preparing the spinous process sac according to claim 1, characterized in that, The welding of the spindle wire to the circular sleeve, and the welding of the circular sleeve to the outer tube and the tip, are all performed on the mandrel. When the spindle wire is welded to the circular sleeve, the mandrel includes a cylindrical stepped mandrel that is simultaneously inserted into the circular sleeve. When the circular sleeve is welded to the outer tube and the tip respectively, the mandrel includes a cylindrical mandrel that is separately inserted into the cavity between the tip and the inner and outer tubes of the proximal end of the balloon.

10. A spiked balloon catheter, characterized in that, The invention includes a spinous process balloon prepared by the method of any one of claims 1-9, and a proximal catheter assembly, wherein the proximal catheter assembly and the spinous process balloon are assembled into an integral structure by hot air welding.

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