Balloon folding method and balloon catheter

Abstract

The present application relates to the field of medical devices, in particular to a balloon folding method and a balloon catheter. The balloon folding method comprises: placing a balloon of a balloon catheter on a folding part of a balloon clamp head; operating the balloon clamp head so that multiple split heads of the balloon clamp head move towards the balloon, thereby clamping the balloon by the multiple split heads; and operating the balloon clamp head to form marks on corresponding petals and rotate around the axis of the balloon catheter to form multiple wound petals. The balloon folding method can fold the balloon into petals and wind the petals, thereby reducing the profile of the balloon and facilitating subsequent packaging. In addition, the balloon folding method can increase the friction between the balloon and the inner wall of the blood vessel during the operation, thereby enhancing the anchoring performance of the balloon when the balloon is expanded in the blood vessel, avoiding the sliding displacement of the balloon in the blood vessel, and thereby ensuring the effect of the expansion treatment and improving the efficiency of the operation.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to a balloon folding method and a balloon catheter. Background Technology

[0002] Vascular diseases are the leading threat to human health. Blood vessels have multiple branches, and often multiple branches become narrowed simultaneously, requiring angioplasty for each branch. Balloon dilation is one of the main methods for angioplasty. During the fabrication of balloon catheters, a step involves folding the balloon. This folding reduces its profile, facilitating subsequent packaging and, more importantly, facilitating the surgeon's manipulation during the procedure (advancing to the lesion area and withdrawing it from the body). Furthermore, during dilation, insufficient surface friction can sometimes lead to the "watermelon seed" effect (i.e., the balloon slips and shifts from the narrowed area during dilation), affecting the dilation effect and surgical efficiency. Summary of the Invention

[0003] The objectives of this invention include, for example, providing a balloon folding method and a balloon catheter that can roll the balloon into flaps, reducing its profile and facilitating subsequent packaging production; it can also increase the friction between the balloon and the inner wall of the blood vessel during surgery, thereby enhancing the anchoring performance of the balloon during intravascular dilation, preventing the balloon from sliding and shifting within the blood vessel, thus ensuring the effectiveness of dilation treatment and improving the efficiency of surgery.

[0004] The embodiments of the present invention can be implemented as follows:

[0005] In a first aspect, the present invention provides a balloon folding method for folding the balloon of a balloon catheter, comprising:

[0006] Place the balloon of the balloon catheter into the fold of the balloon clip;

[0007] Operate the balloon clamp to move the multiple flaps of the balloon clamp toward the balloon, thereby clamping the balloon with the multiple flaps.

[0008] Manipulate the balloon clamp to create an imprint on the corresponding valve, and rotate around the axis of the balloon catheter to form multiple coiled valves.

[0009] In an optional implementation, the balloon folding method includes the following steps prior to placing the balloon of the balloon catheter into the fold of the balloon clamp:

[0010] Operate the balloon clamp so that the multiple segments of the balloon clamp move in a direction away from each other, so that the multiple segments together form a first receiving part, and a second receiving part is formed between any two adjacent segments.

[0011] The first accommodating part and the second accommodating part are connected and together form a folding part.

[0012] In an optional embodiment, when the multiple flaps of the balloon clamp move toward the balloon, the multiple flaps move toward the center of the first receiving portion, thereby reducing the volume of the first receiving portion, so that the balloon gradually moves into the multiple second receiving portions; and adjacent flaps move closer to each other, thereby reducing the volume of the second receiving portion, so that the portion of the balloon located in the second receiving portion is clamped by the two flaps forming the second receiving portion.

[0013] In an optional embodiment, around the axis of the balloon, each valve head is provided with a first clasping surface and a second clasping surface. The first clasping surface is used to cooperate with the second clasping surface of the adjacent valve head and together clamp the balloon to form a valve body.

[0014] One of the mating surfaces, the first and the second, is provided with a pressure groove, and the other of the mating surfaces is provided with a protruding pressure block. The pressure block is used to cooperate with the pressure groove so that when the first and the second mating surfaces jointly clamp the balloon and form the valve, an imprint is formed on the valve body.

[0015] In an optional embodiment, the groove depth is 0.01-0.2 mm and the groove width is 0.01-1 mm.

[0016] In an optional embodiment, the groove includes multiple groove segments, which may be interrupted or continuous.

[0017] Each groove is Z-shaped, S-shaped, or straight.

[0018] In an optional embodiment, each groove segment is straight, and multiple groove segments are arranged in a broken manner and are arranged in parallel.

[0019] In an optional implementation, the interval between two adjacent grooves is 0.5-5 mm.

[0020] In an optional embodiment, the groove includes a plurality of circular holes arranged in an array.

[0021] In a second aspect, the present invention provides a balloon catheter, which is made by the above-mentioned balloon folding method. The balloon catheter includes a tube body and a balloon disposed on the tube body. The balloon includes multiple valves, which are rolled up in the tube body in the same direction, and each valve has multiple imprints on its surface.

[0022] When the balloon is inflated, the imprint forms multiple protrusions on the outer surface of the balloon.

[0023] The beneficial effects of the embodiments of the present invention include:

[0024] This balloon folding method is used to fold the balloon of a balloon catheter, including: placing the balloon of the balloon catheter in the folding part of the balloon clamp; manipulating the balloon clamp so that multiple valve heads of the balloon clamp move toward the balloon, thereby clamping the balloon by the multiple valve heads; manipulating the balloon clamp to form an imprint on the corresponding valve body, and rotating around the axis of the balloon catheter to form multiple coiled valve bodies.

[0025] This balloon folding method allows the balloon to be rolled into flaps, reducing its profile and facilitating subsequent packaging. It also increases the friction between the balloon and the blood vessel wall during surgery, thereby enhancing the balloon's anchoring performance during intravascular dilation and preventing the balloon from sliding or shifting within the blood vessel. This ensures the effectiveness of dilation treatment and improves surgical efficiency. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of the present invention, 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 the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the steps of the balloon folding method in an embodiment of the present invention;

[0028] Figure 2 This is a schematic diagram of the balloon clamp deployment in an embodiment of the present invention;

[0029] Figure 3 This is a schematic diagram of the balloon clamp closing in an embodiment of the present invention;

[0030] Figure 4 This is a schematic diagram of the structure of the first accommodating part and the second accommodating part in an embodiment of the present invention;

[0031] Figure 5 This is a schematic diagram of the pressure groove and pressure block in an embodiment of the present invention;

[0032] Figure 6 This is a schematic diagram of the pressure groove in an embodiment of the present invention.

[0033] Icons: 100-Balloon clamp; 101-Folding part; 110-Split head; 102-First receiving part; 103-Second receiving part; 111-First closing surface; 112-Second closing surface; 113-Pressure groove; 114-Pressure block. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0035] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0036] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0037] In the description of this invention, it should be noted that if terms such as "upper," "lower," "inner," or "outer" are used to indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0038] Furthermore, the terms "first" and "second" are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0039] It should be noted that, where there is no conflict, the features in the embodiments of the present invention can be combined with each other.

[0040] Please refer to Figures 1-3 This embodiment provides a balloon folding method for folding the balloon of a balloon catheter, including:

[0041] S1: Place the balloon of the balloon catheter in the fold 101 of the balloon clamp 100;

[0042] S2: Operate the balloon clamp 100 so that the multiple valve heads 110 of the balloon clamp 100 move toward the balloon, thereby causing the balloon to be clamped by the multiple valve heads 110 and forming multiple valves around the axis of the balloon catheter.

[0043] S3: Operate the balloon clamp 100 to form an imprint on the corresponding valve body, and rotate around the axis of the balloon catheter to form multiple coiled valve bodies.

[0044] Please refer to Figures 1-3 The working principle of this balloon folding method is as follows:

[0045] This balloon folding method is used to fold the balloon of a balloon catheter. By operating the balloon clamp 100, multiple valve heads 110 move toward the balloon, which can clamp the balloon and form multiple coiled valves around the axis of the balloon catheter, and can also form imprints on the valves.

[0046] Because of the imprints on the balloon valves, when the balloon is inflated, these imprints form multiple protrusions on the outer surface of the balloon. This increases the surface roughness of the balloon. It should be noted that the imprints are created using a clamping method. As a result, after the same valve expands and inflates, it will not only form multiple protrusions but also multiple depressions. The depressions have the same effect as the protrusions, both increasing the surface roughness of the balloon.

[0047] Therefore, this balloon folding method can roll the balloon into segments, reducing its profile and facilitating subsequent packaging. It can also increase the friction between the balloon and the inner wall of the blood vessel during surgery, thereby enhancing the anchoring performance of the balloon during intravascular dilation, preventing the balloon from sliding and shifting within the blood vessel, thus ensuring the effectiveness of dilation treatment and improving the efficiency of surgery.

[0048] It should be noted that the balloon catheter made based on the above scheme can also expand when encountering calcified lesions and narrowing. In the inflated state of the balloon, the protrusions on its surface can play an expanding role. That is, when expanding, it can generate local high pressure, which can facilitate the widening of the hardened narrow area, thereby widening the narrow part of the calcified lesion and improving the efficiency of the operation.

[0049] It should also be noted that, Figure 2 and Figure 3 The diagram shows the structure of the balloon clip, which includes 3, 5, and 6 flaps.

[0050] Further, please refer to Figures 1-4 In this embodiment, before the step of placing the balloon of the balloon catheter into the fold 101 of the balloon clamp 100, the balloon folding method includes:

[0051] Operate the balloon clamp 100 so that the multiple flaps 110 of the balloon clamp 100 move in a direction away from each other, so that the multiple flaps 110 together form a first receiving portion 102, and a second receiving portion 103 is formed between any two adjacent flaps 110.

[0052] The first accommodating part 102 is connected to the second accommodating part 103 and together form the folding part 101.

[0053] It should be noted that when operating the balloon clamp 100, the size of the first receiving portion 102 and the second receiving portion 103 can be adjusted by adjusting the distance by which the multiple split heads 110 move away from each other, thereby providing a position to receive the balloon.

[0054] Furthermore, in this embodiment, when the multiple flap heads 110 of the balloon clamp 100 move toward the balloon, the volume of the first accommodating portion 102 and the second accommodating portion 103 changes as the multiple flap heads 110 move, and during the change, the balloon located in the fold portion 101 is clamped.

[0055] Specifically, multiple split heads 110 move toward the center of the first receiving portion 102 to reduce the volume of the first receiving portion 102, thereby allowing the balloon to gradually move into multiple second receiving portions 103; and adjacent split heads 110 move closer to each other to reduce the volume of the second receiving portion 103, thereby causing the portion of the balloon located in the second receiving portion 103 to be clamped by the two split heads 110 forming the second receiving portion 103.

[0056] Further, please refer to Figures 1-6 In order to enable two adjacent flap heads 110 to form a valve body after clamping the balloon, each flap head 110 is provided with a first closing surface 111 and a second closing surface 112 around the axis of the balloon. The first closing surface 111 is used to cooperate with the second closing surface 112 of the adjacent flap head 110 and together clamp the balloon to form a valve body.

[0057] Furthermore, in order to form an imprint on the valve body while forming the valve body, one of the mating first closure surface 111 and the mating second closure surface 112 is provided with a pressure groove 113, and the other of the mating first closure surface 111 and the mating second closure surface 112 is provided with a protruding pressure block 114; the pressure block 114 is used to cooperate with the pressure groove 113 so that when the first closure surface 111 and the second closure surface 112 jointly clamp the balloon and form the valve body, an imprint is formed on the valve body.

[0058] It should be noted that when setting the above-mentioned pressure groove 113, the pressure groove 113 can be processed by laser, etching and precision machining. In addition, when setting the pressure block 114, its function is to cooperate with the pressure groove 113 to form an indentation on the petal body. Thus, the pressure block 114 has a contour that is adapted to the pressure groove 113, and the pressure block 114 needs to be matched with the pressure groove 113. Therefore, in this embodiment, only the contour shape of the pressure groove 113 is described, and the pressure block 114 only needs to have a contour shape that is adapted to the corresponding pressure groove 113.

[0059] When forming the aforementioned imprint, a groove 113 is provided on the first apical surface 111 or the second apical surface 112. When providing the groove 113, to ensure that the imprint formed by the groove 113 on the corresponding valve body can form a protrusion after balloon inflation, please refer to... Figure 5 The groove depth of the pressure groove 113 and the height of the pressure block can be 0.01-0.2mm (e.g. Figure 5 As shown in the reference numeral B), the groove width of the pressure groove 113 and the width of the pressure block can be 0.01-1mm (e.g., ...). Figure 5 (as shown in the label A).

[0060] Furthermore, when arranging the pressure groove 113, the pressure groove 113 includes multiple groove segments, which may be interrupted or continuous; each groove segment is Z-shaped (e.g., Figure 6 (as shown by the mark C in the middle), S-shaped (as shown in the middle) Figure 6 (as shown by the mark D in the middle) or linear (as shown in the middle) Figure 6 (As indicated by mark E in the middle). Furthermore, when each groove segment is straight and multiple groove segments are interrupted, and these multiple groove segments are arranged in parallel, it should be noted that when the pressing groove 113 includes multiple groove segments, the interval between two adjacent groove segments can be 0.5-5mm. In addition, the pressing groove 113 may also include multiple circular holes (such as...). Figure 6 As shown by the mark F in the middle, multiple circular holes are arranged in an array.

[0061] Please refer to Figures 1-6 Based on the above-described balloon folding method, this embodiment also provides a balloon catheter. The balloon catheter is made using the above-described balloon folding method. The balloon catheter includes a tube body and a balloon disposed on the tube body. The balloon includes multiple valves, which are rolled up in the tube body in the same direction, and each valve has multiple imprints on its surface. When the balloon is inflated, the imprints form multiple protrusions on the outer surface of the balloon.

[0062] Therefore, by adopting the above method, the balloon is in a segmented and rolled-up state when it is in the contracted state, that is, multiple segments are rolled up in the tube in the same direction. In this way, the outline and volume of the balloon in the contracted state can be reduced, which facilitates the production of subsequent packaging.

[0063] When the balloon is inflated, the imprints on the multiple valves can form multiple protrusions on the outer surface of the balloon. The presence of these protrusions increases the roughness of the balloon surface, thereby increasing the friction between the balloon and the inner wall of the blood vessel. This enhances the anchoring performance of the balloon during intravascular dilation, preventing the balloon from sliding or shifting within the blood vessel, thus ensuring the effectiveness of the dilation treatment and improving the efficiency of the procedure.

[0064] The applicant further compared a balloon prepared by first imprinting the balloon and then folding it into segments. While this balloon could also effectively prevent the "watermelon seed" effect, its foldability was flawed. The outer diameter of the folded balloon was on average 2 mm larger than that of the balloon prepared in this application, and the folding was looser.

[0065] The above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A balloon folding method for folding the balloon of a balloon catheter, characterized in that, include: The balloon clamp is operated so that the multiple flaps of the balloon clamp move in a direction away from each other, so that the multiple flaps together form a first receiving portion, and a second receiving portion is formed between any two adjacent flaps; wherein the first receiving portion and the second receiving portion are connected and together form a folded portion; Place the balloon of the balloon catheter into the fold of the balloon clip; Operate the balloon clamp so that the multiple flaps of the balloon clamp move toward the balloon, thereby causing the balloon to be clamped by the multiple flaps; The balloon clamp is operated to form an imprint on the corresponding valve body, and rotated around the axis of the balloon catheter to form multiple coiled valve bodies; Around the axis of the balloon, each of the segmented heads is provided with a first closing surface and a second closing surface. The first closing surface is used to cooperate with the second closing surface of the adjacent segmented head and together clamp the balloon to form the valve body. One of the cooperating first closing surface and the second closing surface is provided with a pressure groove, and the other of the cooperating first closing surface and the second closing surface is provided with a protruding pressure block. The pressure block is used to cooperate with the pressure groove to form an imprint on the valve body when the first closing surface and the second closing surface jointly clamp the balloon and form the valve body.

2. The balloon folding method according to claim 1, characterized in that: When the multiple flaps of the balloon clamp move toward the balloon, the multiple flaps move toward the center of the first receiving portion, thereby reducing the volume of the first receiving portion, so that the balloon gradually moves into the multiple second receiving portions; and two adjacent flaps move closer to each other, thereby reducing the volume of the second receiving portion, so that the portion of the balloon located in the second receiving portion is clamped by the two flaps forming the second receiving portion.

3. The balloon folding method according to claim 1, characterized in that: The depth of the pressing groove is 0.01-0.2mm, and the width of the pressing groove is 0.01-1mm.

4. The balloon folding method according to claim 1, characterized in that: The pressure groove includes multiple groove segments, which may be interrupted or continuous. Each groove is Z-shaped, S-shaped, or straight.

5. The balloon folding method according to claim 4, characterized in that: Each of the groove segments is straight, and the groove segments are arranged in a broken manner and are arranged in parallel.

6. The balloon folding method according to claim 4, characterized in that: The interval between two adjacent grooves is 0.5-5mm.

7. The balloon folding method according to claim 1, characterized in that: The pressure groove includes multiple circular holes, which are arranged in an array.

8. A balloon catheter, manufactured using the balloon folding method as described in any one of claims 1-7, characterized in that: The balloon catheter includes a tube body and a balloon disposed on the tube body. The balloon includes multiple valves, which are wound around the tube body in the same direction, and each valve has multiple imprints on its surface. When the balloon is inflated, the imprint forms multiple protrusions on the outer surface of the balloon.

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