Balloon forming equipment and method

Abstract

The invention provides a balloon forming device and method, and relates to the technical field of medical device.The balloon forming device comprises a far-end mold with a first inner cavity, a middle mold with a second inner cavity and a near-end mold with a third inner cavity which are connected in sequence, and after the far-end mold, the middle mold and the near-end mold are connected, the first inner cavity, the second inner cavity and the third inner cavity are formed; the first inner cavity, the second inner cavity and the third inner cavity are communicated and can contain a to-be-formed balloon piece. The first inner cavity at least partially accommodates a conical tube section at the far end of a to-be-formed balloon piece, and the third inner cavity at least partially accommodates a conical tube section at the near end of the to-be-formed balloon piece; at least one of the far-end mold and the near-end mold comprises an adjusting mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed by adjusting the adjusting mechanism, in this way, the hole diameter of the far-end mold and the hole diameter of the near-end mold can be adjusted, in the subsequent stretching process, the wall thickness of the conical part and the waist part of the balloon is reduced, and the balloon stretching efficiency is improved. And the wall thickness of the balloon is more uniform, so that the quality and the performance of the product are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a balloon forming device and method. Background Art

[0002] Balloon dilation catheters are widely used in applications related to vascular treatment. For example, arterial stenosis is usually treated by angioplasty. The most widely used form of angioplasty is to use a dilation catheter with an inflatable balloon at its distal end. Under X-ray angiography, a doctor inserts the catheter through the vascular system until the balloon passes through the stenosis. Subsequently, the balloon is inflated with a liquid under a certain pressure by filling the cavity, so that the balloon expands.

[0003] Balloon forming technology involves stretching and blowing a balloon from an extruded polymer tube. A balloon forming die usually consists of an intermediate die and an end die. The intermediate die and the end die are made of the same material. The temperature is transferred to the end die by heating the water jacket of the balloon forming machine and then transferring the temperature of the intermediate die to the end die. Finally, the balloon is manufactured through program optimization of balloon forming and optimization of the forming end die.

[0004] The process of balloon forming is divided into two stages: primary stretching and secondary stretching. Primary stretching is a key stage in the balloon forming process. Through primary stretching, the overall shape and size of the balloon can be initially formed. After primary stretching, there may be certain non-uniformity and thickness deviation in the wall thickness of the waist and cone parts of the balloon. At this time, secondary stretching is carried out. During the two stretching processes, it is difficult to adjust the end die and the intermediate die. The degree of adjusting the wall thickness of the waist and cone parts of the balloon by secondary stretching is limited, and the effect of secondary stretching is not good, thus resulting in non-uniform wall thickness of the balloon. Summary of the Invention

[0005] The purpose of the present invention is to provide a balloon forming device in view of the deficiencies of the prior art. This balloon forming device can adjust the wall thickness of the balloon by adjusting the inner diameter of the inner wall of the balloon die, so as to achieve the purpose of reducing the wall thickness of the cone part and the waist part of the balloon.

[0006] The present invention provides a balloon forming device, which includes a distal die with a first inner cavity, an intermediate die with a second inner cavity, and a proximal die with a third inner cavity that are connected in sequence. After the distal die, the intermediate die, and the proximal die are connected, the first inner cavity, the second inner cavity, and the third inner cavity are communicated and can accommodate a balloon part to be formed; at least part of the first inner cavity accommodates the cone tube section at the distal end of the balloon part to be formed, and at least part of the third inner cavity accommodates the cone tube section at the proximal end of the balloon part to be formed; at least one of the distal die and the proximal die includes an adjusting mechanism, and by adjusting the adjusting mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed.

[0007] In a possible implementation, a limit adjusting member is further included; the limit adjusting member is in transmission connection with the adjusting mechanism to drive the adjusting mechanism to move, so as to form the first inner cavity or the third inner cavity with different inner diameters.

[0008] In a possible implementation, the adjusting mechanism includes a plurality of adjusting flaps, and the plurality of adjusting flaps are sequentially adjacent to enclose the first inner cavity or the third inner cavity; the plurality of adjusting flaps can rotate around the axis of the first inner cavity or the third inner cavity, and during the rotation, the adjusting flaps can move radially closer to or away from the central axis of the first inner cavity, so as to increase or decrease the inner diameter of the first inner cavity or the third inner cavity.

[0009] In a possible implementation, a first limiting plate and a second limiting plate are further included; the first limiting plate is adjacent to the outer peripheral wall of the distal mold and can limit the extreme position of the movement of the adjusting flap in the distal mold away from the central axis; the second limiting plate is adjacent to the outer peripheral wall of the proximal mold and can limit the extreme position of the movement of the adjusting flap in the proximal mold away from the central axis.

[0010] In a possible implementation, a limiting plate is further included, and the limiting plate is arranged on the distal mold and also on the proximal mold, and the limiting plate can cooperate with the adjusting flap.

[0011] In a possible implementation, a first heating device, a second heating device and a third heating device controlled by an independent switch are further included, the first heating device is arranged on the distal mold, the second heating device is arranged on the intermediate mold, and the third heating device is arranged on the proximal mold.

[0012] In a possible implementation, a first heat insulating member and a second heat insulating member are further included, the first heat insulating member is arranged between the intermediate mold and the distal mold, and the second heat insulating member is arranged between the intermediate mold and the proximal mold.

[0013] In a possible implementation, a distal mold seat and a proximal mold seat are further included, the distal mold seat is connected to the distal mold, and the proximal mold seat is connected to the proximal mold; the distal mold seat and the proximal mold seat are made of heat insulating materials, and the intermediate mold, the distal mold and the proximal mold are made of heat conducting materials.

[0014] In a possible implementation, the distal mold, the proximal mold and the intermediate mold are coaxially arranged.

[0015] A balloon forming method is applied to a balloon forming device. The balloon forming method includes:

[0016] Place the balloon part to be formed in the inner cavity of the balloon forming device. At least part of the tapered tube section at the distal end of the distal catheter and the balloon part of the balloon part to be formed is located in the first inner cavity, part of the balloon part is located in the second inner cavity, and at least part of the tapered tube section at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed is located in the third inner cavity;

[0017] Adjust the adjusting mechanism so that the inner diameter value of the first inner cavity reaches a first preset inner diameter, and the inner diameter value of the third inner cavity reaches a second preset inner diameter. In the inflated state, stretch the balloon part to be formed until the balloon part to be formed fits against the first inner cavity, the second inner cavity, and the third inner cavity;

[0018] Adjust the adjusting mechanism so that the inner diameter value of the first inner cavity reaches a fourth preset inner diameter, and the inner diameter value of the third inner cavity reaches a fifth preset inner diameter. In the inflated state, heat the distal mold and the proximal mold to perform secondary stretching of the balloon part to be formed until the balloon part to be formed fits against the first inner cavity, the second inner cavity, and the third inner cavity; the fourth preset inner diameter is greater than the first preset inner diameter, and the fifth preset inner diameter is greater than the second preset inner diameter;

[0019] After cooling and shaping, a formed balloon part is obtained.

[0020] In a possible implementation, before adjusting the adjusting mechanism so that the inner diameter value of the first inner cavity reaches a fourth preset inner diameter and the inner diameter value of the third inner cavity reaches a fifth preset inner diameter, it further includes reducing the output air pressure value of the ventilation device so that there is a gap between at least part of the tapered tube section at the distal end of the distal catheter and the balloon part of the balloon part to be formed and the inner cavity wall of the first inner cavity, and there is a gap between at least part of the tapered tube section at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed and the inner cavity wall of the third inner cavity.

[0021] In a possible implementation, before heating the distal mold and the proximal mold to perform secondary stretching of the balloon part to be formed, it further includes reducing the temperature of the intermediate mold so that part of the balloon part is cooled and shaped.

[0022] A balloon forming device provided by the present application has the following beneficial effects:

[0023] The present application provides a balloon forming device, which relates to the field of medical technology and includes a distal mold with a first inner cavity, an intermediate mold with a second inner cavity, and a proximal mold with a third inner cavity that are connected in sequence. After the distal mold, the intermediate mold, and the proximal mold are connected, the first inner cavity, the second inner cavity, and the third inner cavity communicate with each other and can accommodate the balloon part to be formed; at least part of the first inner cavity accommodates the tapered pipe section at the distal end of the balloon part to be formed, and at least part of the third inner cavity accommodates the tapered pipe section at the proximal end of the balloon part to be formed; at least one of the distal mold and the proximal mold includes an adjustment mechanism, and by adjusting the adjustment mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed. In this way, the apertures of the distal mold and the proximal mold can be adjusted, and during the subsequent stretching process, the wall thickness of the tapered part and the waist of the balloon is reduced, and the wall thickness of the balloon is more uniform, thereby improving the quality and performance of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0025] Figure 1 Structural schematic diagram of the distal mold of the balloon forming device according to the embodiment of the present application;

[0026] Figure 2 Structural schematic diagram of the balloon forming device before adjustment according to the embodiment of the present application;

[0027] Figure 3 Structural schematic diagram of the balloon forming device after adjustment according to the embodiment of the present application;

[0028] Figure 4 Partial structural schematic diagram of the distal mold of the balloon forming device according to the embodiment of the present application;

[0029] Figure 5 Partial structural schematic diagram of the proximal mold of the balloon forming device according to the embodiment of the present application;

[0030] The following is a supplementary description of the drawings:

[0031] 10. Intermediate mold; 20. Distal mold; 21. Distal mold base; 22. First limit adjustment member; 30. Proximal mold; 31. Proximal mold base; 32. Second limit adjustment member; 40. First heat insulation member; 50. Second heat insulation member; 23. First arc segment; 24. Second arc segment; 25. Third arc segment. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] To enable those skilled in the art to better understand the solution of this application, the following will clearly and completely describe the technical solution in the embodiments of this application in conjunction with the accompanying drawings in the embodiments of this application. Obviously, the described embodiments are only a part of the embodiments of this application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope protected by this application.

[0033] As used herein, "one embodiment" or "an embodiment" refers to a specific feature, structure, or characteristic that may be included in at least one implementation of this application. In the description of this application, it should be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "top", "bottom", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing this application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to this application. In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. Moreover, the terms "first", "second", etc. are used to distinguish similar objects, and do not necessarily have to be used to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of this application described here can be implemented in an order other than those illustrated or described here.

[0034] In the prior art, for most materials, the wall thickness of the working section of the balloon wall is usually on the order of 0.0003 to 0.003 in. And due to the small waist diameter, the wall thickness of the waist and cone parts is much larger than that of the working section of the balloon wall. The profile of the balloon is limited by the thickness of its waist and cone parts. To reduce the overall profile of the balloon, the problem of excessive wall thickness in the waist and cone parts must be solved.

[0035] In view of this, to solve at least one of the above problems, this application provides a balloon forming device that produces a formed balloon part with uniform wall thickness in the waist and cone parts by adjusting the inner diameters of the inner cavities of the distal mold and the proximal mold.

[0036] The following introduces a balloon forming device provided by an embodiment of the present application in conjunction with the accompanying drawings. The device includes a distal mold 20 having a first inner cavity, an intermediate mold 10 having a second inner cavity, and a proximal mold 30 having a third inner cavity, which are connected in sequence. After the distal mold 20, the intermediate mold 10, and the proximal mold 30 are connected, the first inner cavity, the second inner cavity, and the third inner cavity communicate with each other and can accommodate the balloon part to be formed. At least part of the tapered tube section at the distal end of the balloon part to be formed is accommodated in the first inner cavity, and at least part of the tapered tube section at the proximal end of the balloon part to be formed is accommodated in the third inner cavity. At least one of the distal mold 20 and the proximal mold 30 includes an adjustment mechanism. By adjusting the adjustment mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed. In this way, the apertures of the distal mold 20 and the proximal mold 30 can be adjusted. During the secondary stretching process, the balloon part to be formed is softened and blow-molded to fit the adjusted first inner cavity and third inner cavity, thereby reducing the wall thickness of the tapered part and the waist of the balloon, making the wall thickness of the balloon more uniform, and improving the quality and performance of the product.

[0037] It can be understood that in the present application, the inner diameters of the first inner cavity of the distal mold 20 and the second inner cavity of the proximal mold 30 are adjusted to the required set values ФA and ФC through the above-mentioned solution. After the balloon is subjected to the first stretching and before the second stretching, the inner diameters of the first inner cavity of the distal mold 20 and the second inner cavity of the proximal mold 30 are adjusted to the required set values ФB and ФD, and then the secondary stretching process of the balloon is carried out to solve the problem that the wall thickness ratio of the waist and the cone is too large compared with the wall thickness of the working section of the balloon.

[0038] Specifically, the distal mold 20 having a first inner cavity can accommodate the distal catheter of the balloon part to be formed and at least part of the tapered tube section at the distal end of the balloon part to be formed. The proximal mold 30 having a third inner cavity can accommodate the proximal catheter of the balloon part to be formed and at least part of the tapered tube section at the proximal end of the balloon part to be formed. The intermediate mold 10 having a second inner cavity can accommodate the balloon part of the balloon part to be formed.

[0039] In this embodiment, the inner diameters of the first inner cavity and the third inner cavity are smaller than the inner diameter of the second inner cavity, and the inner diameter of the first inner cavity is larger than the inner diameter of the third inner cavity.

[0040] In one embodiment, the part of the balloon part to be formed located in the intermediate mold 10 is defined as the working section. The tapered part and the waist of the balloon part to be formed are located in the distal mold 20 and the proximal mold 30. The distal pin and the proximal pin of the balloon part to be formed are both the waist of the balloon part to be formed.

[0041] Specifically, by adjusting the adjustment mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed, so as to adjust the outer diameter of the part of the balloon part to be formed located in the first inner cavity and the third inner cavity.

[0042] In this embodiment, the aperture diameter of the intermediate mold 10 does not need to be adjusted. The inner diameter of the second inner cavity is set to a third preset inner diameter. The outer diameter of the working section of the balloon part to be formed varies with the value of the third preset inner diameter. The adjusting mechanism is arranged on the distal mold 20 and the proximal mold 30. The parts of the balloon part to be formed located in the first inner cavity and the third inner cavity are adjusted in terms of the wall thickness of the balloon part to be formed through actions such as heating, stretching, and ventilation.

[0043] Specifically, the diameters of the parts where the distal mold 20 and the proximal mold 30 cooperate with the intermediate mold 10 do not change. The outer diameter of the conical part of the balloon part to be formed located in the intermediate mold remains unchanged. The outer diameters of the conical parts of the balloon part to be formed located in the distal mold 20 and the proximal mold 30 change with the first preset inner diameter and the third preset inner diameter. The angles of the conical parts and the pipe diameters of the waists of the balloon part to be formed are different during the adjustment process before and after the secondary stretching.

[0044] Optionally, the adjusting mechanism can be a manual adjusting screw, an electric adjusting mechanism, a hydraulic adjusting mechanism, a pneumatic adjusting mechanism, etc.

[0045] Furthermore, a limit adjusting part is further included; the limit adjusting part is in transmission connection with the adjusting mechanism to drive the adjusting mechanism to move, so as to form the first inner cavity or the third inner cavity with different inner diameters. By controlling the adjusting mechanism, the inner diameter of the balloon part is accurately controlled to adapt to different production requirements and application scenarios, and the product quality is improved.

[0046] In this embodiment, the first limit adjusting part 22 is arranged on the distal mold 20. By adjusting the first limit adjusting part 22, the inner diameter of the first inner cavity is adjusted. The second limit adjusting part 32 is arranged on the proximal mold 30. By adjusting the second limit adjusting part 32, the inner diameter of the third inner cavity is adjusted.

[0047] Specifically, the limit adjusting parts are arranged on the distal mold 20 and the proximal mold 30. By adjusting the limit adjusting parts, the adjusting mechanism is adjusted, so as to adjust the inner diameters of the first inner cavity and the third inner cavity, and further adjust the outer diameters of the distal catheter and the proximal catheter of the balloon part to be formed.

[0048] Furthermore, the adjusting mechanism includes a plurality of adjusting flaps. The plurality of adjusting flaps are adjacently arranged in sequence to enclose the first inner cavity or the third inner cavity; the plurality of adjusting flaps can rotate around the axis of the first inner cavity or the third inner cavity, and during the rotation, the adjusting flaps can move radially closer to or away from the central axis of the first inner cavity to increase or decrease the inner diameter of the first inner cavity or the third inner cavity. Through the axial rotation and radial movement of the plurality of adjusting flaps, the precise adjustment of the first inner cavity and the third inner cavity is realized. Different types of adjusting flaps can flexibly adjust the inner cavity size, so that the production line can produce balloon parts of various different specifications and sizes.

[0049] Specifically, the regulating flaps are arranged radially. The regulating flap includes a first arc segment 23, a second arc segment 24, and a third arc segment 25 arranged in sequence along the direction away from the inner cavity. One end of the regulating flap facing the inner cavity forms the first arc segment 23. A plurality of first arc segments 23 are adjacent to each other, and a plurality of first arc segments 23 can form a circular first inner cavity or a second inner cavity; there is an overlapping part between adjacent first arc segments 23. During the process of adjusting the inner diameter of the first inner cavity, the larger the overlapping part of the first arc segments 23 with each other, the smaller the inner diameter of the first inner cavity, and the smaller the overlapping part of the first arc segments 23 with each other, the larger the inner diameter of the first inner cavity; one end of the regulating flap facing away from the inner cavity forms the second arc segment 24 and the third arc segment 25. The second arc segment 24 and the third arc segment 25 are arranged on the periphery of the regulating flap. The second arc segment 24 is used to abut against the first limit adjusting member 22 and the second limit adjusting member 32. By adjusting the first limit adjusting member 22 and the second limit adjusting member 32, the force-bearing condition of the second arc segment 24 is adjusted, thereby adjusting the rotation direction of each regulating flap to change the inner diameter of the first inner cavity or the third inner cavity.

[0050] In this embodiment, during the process that each regulating flap rotates around the axis of the first inner cavity and rotates along the radial direction towards the central axis of the first inner cavity, the part of the first arc segment 23 exposed to the first inner cavity gradually decreases, and thus the inner diameter of the first inner cavity gradually decreases; during the process that each regulating flap rotates around the axis of the first inner cavity and rotates along the radial direction away from the central axis of the first inner cavity, the part of the first arc segment 23 exposed to the first inner cavity gradually increases, and thus the inner diameter of the first inner cavity gradually increases; during the process that each regulating flap rotates around the axis of the third inner cavity and rotates along the radial direction towards the central axis of the third inner cavity, the part of the first arc segment 23 exposed to the third inner cavity gradually decreases, and thus the inner diameter of the third inner cavity gradually decreases; during the process that each regulating flap rotates around the axis of the third inner cavity and rotates along the radial direction away from the central axis of the third inner cavity, the part of the first arc segment 23 exposed to the third inner cavity gradually increases, and thus the inner diameter of the third inner cavity gradually increases.

[0051] In this embodiment, the first limit adjusting member 22 and the second limit adjusting member 32 are set as bolts.

[0052] In one embodiment, at least two first limit adjusting members 22 are provided. At least one of the at least two first limit adjusting members 22 reduces the inner diameter of the first inner cavity, and the adjustment direction of at least another first limit adjusting member 22 is opposite to that of the former to increase the inner diameter of the first inner cavity. Exemplarily, when adjusting one first limit adjusting member 22, the plurality of adjusting flaps rotate in the clockwise direction, and the inner diameter of the first inner cavity decreases; when adjusting the other first limit adjusting member 22, the plurality of adjusting flaps rotate in the counterclockwise direction, and the inner diameter of the first inner cavity increases. At least two second limit adjusting members 32 are provided. At least one of the at least two second limit adjusting members 32 reduces the inner diameter of the first inner cavity, and the adjustment direction of at least another second limit adjusting member 32 is opposite to that of the former to increase the inner diameter of the third inner cavity. Exemplarily, when adjusting one second limit adjusting member 32, the plurality of adjusting flaps rotate in the clockwise direction, and the inner diameter of the third inner cavity decreases; when adjusting the other second limit adjusting member 32, the plurality of adjusting flaps rotate in the counterclockwise direction, and the inner diameter of the third inner cavity increases.

[0053] Specifically, the third arc segment 25 forms the outer peripheral circle of the adjusting flap and can abut against the distal mold base 21 and the proximal mold base 31. The third arc segment 25 can provide additional support and sealing, so that the adjusting flap is not easily deformed or displaced during operation, ensuring that the adjusting flap remains stable during operation.

[0054] Specifically, the adjustment of the adjusting flap is stepless, and it can be adjusted within a continuous range, rather than only being adjusted at a fixed number of positions. Stepless adjustment can more precisely control the rotation angle of the adjusting flap, making the balloon forming device more flexible and efficient, so as to meet the requirements under different working conditions. As the number of adjusting flaps increases, the adjustment range of the inner diameter of the first inner cavity or the third inner cavity becomes smaller, thereby forming a more precise adjustment.

[0055] Further, a first limit plate (not shown) and a second limit plate (not shown) are further included. The first limit plate is adjacent to the outer peripheral wall of the distal mold 20 and can limit the extreme position of the movement of the adjusting flap in the distal mold 20 away from the central axis. The second limit plate is adjacent to the outer peripheral wall of the proximal mold 30 and can limit the extreme position of the movement of the adjusting flap in the proximal mold 30 away from the central axis. By providing the limit plates, the position of the adjusting flap can be ensured to be within an accurate range, thereby realizing precise control of the inner diameter of each inner cavity, and the possibility of human operation error can also be reduced, improving the accuracy and reliability of production.

[0056] In one embodiment, the first limiting plate and the second limiting plate are arranged as arc-shaped limiting plates and can cooperate with the adjusting flap. The third arc section 25 of the adjusting flap can abut against the first limiting plate and the second limiting plate. In the distal mold, after the adjusting flap reaches the limit position during the movement away from the central axis, the third arc section 25 of the adjusting flap abuts against the first limiting plate; in the proximal mold, after the adjusting flap reaches the limit position during the movement away from the central axis, the third arc section 25 of the adjusting flap abuts against the second limiting plate.

[0057] Further, it further includes a first heating device (not shown), a second heating device (not shown), and a third heating device (not shown) controlled by independent control switches. The first heating device is arranged on the distal mold 20, the second heating device is arranged on the intermediate mold 10, and the third heating device is arranged on the proximal mold 30. The opening and closing of the first heating device, the second heating device, and the third heating device can be independently controlled. In this way, each heating device can accurately control the heating of molds at different positions according to needs, thereby improving production efficiency and the quality of the balloon formed parts.

[0058] Specifically, the first heating device, the second heating device, and the third heating device are regulated by a control device, and the temperatures of the corresponding distal mold 20, intermediate mold 10, and proximal mold 30 can be independently controlled. The temperatures of each mold do not change with the temperatures of other molds, that is, the temperatures of the distal mold 20, intermediate mold 10, and proximal mold 30 can be the same or different.

[0059] In this embodiment, the control device can control the temperatures of each heating device, the stretching device, the ventilation device, etc.

[0060] Optionally, the first heating device, the second heating device, and the third heating device can be heating wires, heating plates, or other heating elements.

[0061] In one embodiment, the first heating device, the second heating device, and the third heating device are water jacket heating devices. The water jacket heating device includes an outer jacket, and a heating medium (water or oil) flows inside the jacket. The water jacket heating device transfers heat through the circulation of the heating medium.

[0062] Further, it further includes a first heat insulating member 40 and a second heat insulating member 50. The first heat insulating member 40 is arranged between the intermediate mold 10 and the distal mold 20, and the second heat insulating member 50 is arranged between the intermediate mold 10 and the proximal mold 30. The arrangement of the first heat insulating member 40 and the second heat insulating member 50 effectively isolates and reduces the heat conduction between the molds, ensuring temperature control during the balloon forming process.

[0063] Specifically, the first heat insulator 40 and the second heat insulator 50 are heat-insulating materials, and the shapes of the first heat insulator 40 and the second heat insulator 50 match the shapes of the intermediate mold 10, the distal mold 20, and the proximal mold 30, thereby effectively reducing heat transfer.

[0064] Optionally, the first heat insulator 40 and the second heat insulator 50 can be made of materials such as silica gel, silicate board, aluminum silicate fiber felt, or ceramic fiber.

[0065] Furthermore, it further includes a distal mold base 21 and a proximal mold base 31. The distal mold base 21 is connected to the distal mold 20, and the proximal mold base 31 is connected to the proximal mold 30. The distal mold base 21 and the proximal mold base 31 are heat-insulating materials, and the intermediate mold 10, the distal mold 20, and the proximal mold 30 are made of heat-conductive materials. Setting the distal mold base 21 and the proximal mold base 31 can support the distal mold 20 and the proximal mold 30, and using heat-insulating materials to make the distal mold base 21 and the proximal mold base 31 can reduce heat conduction and dissipation, thereby improving the efficiency of the first heating device, the second heating device, and the third heating device.

[0066] Specifically, the distal mold 20 is disposed on the distal mold base 21, the distal mold base 21 can support the distal mold 20, the proximal mold base 31 can support the proximal mold 30, and the distal mold base 21 and the proximal mold base 31 are respectively sleeved on the distal mold 20 and the proximal mold 30, and it is difficult for external substances to enter the distal mold 20 and the proximal mold 30, thereby extending the service life of the distal mold 20 and the proximal mold 30.

[0067] Optionally, the distal mold 20, the intermediate mold 10, and the proximal mold 30 can be made of metal materials, carbon materials, heat-conductive plastics, or other materials with heat conductivity; the distal mold base 21 and the proximal mold base 31 can be made of ceramic fiber, perlite, silicate fiber, carbon fiber reinforced plastic, or other heat-insulating materials.

[0068] Furthermore, the distal mold 20, the proximal mold 30, and the intermediate mold 10 are coaxially arranged. In this way, the coaxial arrangement minimizes the contact area between the molds, effectively reduces heat loss, and improves product quality. The molds are on the same axis, and the axial force is used to tightly connect the molds to form a solid support structure, which is beneficial to transmitting and sharing the loads of the molds, improving the rigidity and stability of the overall structure, and is also more conducive to the integration of an automated production line and improving the production automation level.

[0069] In one embodiment, the distal mold 20, the proximal mold 30, and the intermediate mold 10 are fixedly connected to the same rail bracket by bolts to form a coaxial structure, and then the control device controls the distal mold 20, the intermediate mold 10, and the proximal mold 30 to stretch on the same rail.

[0070] The following introduces the process flow of the balloon forming device in combination with specific application scenarios:

[0071] A balloon forming method is applied to a balloon forming device. The balloon forming method includes:

[0072] S101. Place the balloon part to be formed in the inner cavity of the balloon forming device. At least part of the tapered tube section at the distal end of the distal catheter and the balloon part of the balloon part to be formed is located in the first inner cavity, part of the balloon part is located in the second inner cavity, and at least part of the tapered tube section at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed is located in the third inner cavity;

[0073] Specifically, the balloon part to be formed refers to a section of tube material before balloon forming. The balloon part to be formed includes a distal catheter, a balloon part, and a proximal catheter and can be placed in the inner cavity of the mold. The distal catheter and the distal end of the balloon part include a tapered tube section, and part of the balloon part is located in the second inner cavity; the proximal catheter and the proximal end of the balloon part also include a tapered tube section, and part of the tapered tube section is located in the third inner cavity. The working part and the tapered part of the balloon part extend through the three inner cavities.

[0074] In this embodiment, the tapered tube sections at the distal end of the distal catheter and the balloon part of the balloon part to be formed are located in the first inner cavity, and the tapered tube sections at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed are located in the third inner cavity.

[0075] S102. Adjust the adjusting mechanism so that the inner diameter value of the first inner cavity reaches the first preset inner diameter, and the inner diameter value of the third inner cavity reaches the second preset inner diameter. In the inflated state, stretch the balloon part to be formed until the balloon part to be formed fits against the first inner cavity, the second inner cavity, and the third inner cavity;

[0076] Specifically, the first preset inner diameter ФA is the outer diameter of the distal catheter of the balloon part to be formed during a single stretching process, and is also the outer diameter of the tapered tube section at the distal end of the balloon part connected to the distal catheter. The second preset inner diameter ФC is the outer diameter of the proximal catheter of the balloon part to be formed during a single stretching process, and is also the outer diameter of the tapered tube section at the proximal end of the balloon part connected to the proximal catheter. The first preset inner diameter is smaller than the outer diameter of the distal catheter of the balloon part to be formed, and the second preset inner diameter is smaller than the outer diameter of the proximal catheter of the balloon part to be formed; in this embodiment, ФA is less than ФC, that is, the outer diameter of the distal catheter is less than the outer diameter of the proximal catheter; the third preset inner diameter is the inner diameter of the second inner cavity formed by the intermediate mold 10 and is the outer diameter of the working part of the balloon part to be formed.

[0077] S102 also includes:

[0078] S301. Heat the distal mold 20, proximal mold 30 and intermediate mold 10. Connect the ventilation device to one end of the balloon part to be formed, and stretch the balloon part to be formed until the balloon part, tapered part and waist of the balloon part to be formed fit with the first inner cavity, second inner cavity and third inner cavity;

[0079] Specifically, the ventilation device includes a gas source, which is connected to one end of the balloon part to be formed, and the other end is sealed. In other embodiments, the gas source of the ventilation device is connected to both ends of the balloon part to be formed.

[0080] S302. Adjust the temperature of the second heating device, first heat and then cool the balloon part of the balloon part to be formed to form the balloon part of the formed balloon part;

[0081] Specifically, the cooling and shaping of the balloon part of the balloon part can prevent the balloon part of the balloon part to be formed from deforming and generating dimensional deviations during the secondary stretching process, which helps to control the shape and size of the formed balloon part.

[0082] Specifically, by reducing the temperature of the intermediate mold 10, the balloon part can be cooled and shaped, thereby preventing the balloon part from deforming or being damaged during the stretching process. Appropriate cooling can also improve the stability and consistency of the balloon part, thereby improving the quality and forming success rate of the product. The second heating device of the intermediate mold 10 uses a cooling water tank.

[0083] In other embodiments, after the secondary stretching, adjust the temperature of the second heating device to cool the balloon part to be formed to form the formed balloon part. By controlling the temperature and cooling process of each mold, the forming process of the balloon part to be formed can be ensured to have consistency, and energy can be used more effectively, reducing the energy consumption during the forming process, thereby improving the stability and reliability of the product.

[0084] S303. Reduce the output air pressure value of the ventilation device so that there is a gap between at least part of the tapered tube section of the distal catheter of the balloon part to be formed and the distal end of the balloon part and the cavity wall of the first inner cavity, and there is a gap between at least part of the tapered tube section of the proximal catheter of the balloon part to be formed and the proximal end of the balloon part and the cavity wall of the third inner cavity.

[0085] In this way, it is possible to prevent the air pressure from being too high, and in the case of the aperture being adjusted but in the non-stretched state, prevent the distal catheter and proximal catheter of the balloon part to be formed from deforming and damaging the balloon part to be formed, which helps to better control the shape and size of the balloon part during the forming process and improve the forming success rate of the product.

[0086] S103. Adjust the adjusting mechanism to make the inner diameter value of the first inner cavity reach the fourth preset inner diameter and the inner diameter value of the third inner cavity reach the fifth preset inner diameter. Under the inflated state, heat the distal mold 20 and the proximal mold 30 to perform secondary stretching on the balloon part to be formed until the balloon part to be formed fits into the first inner cavity, the second inner cavity, and the third inner cavity; the fourth preset inner diameter is greater than the first preset inner diameter, and the fifth preset inner diameter is greater than the second preset inner diameter.

[0087] In this embodiment, by adjusting the adjusting mechanism, the increasing inner cavity size can enable the balloon part to better expand under the inflated state and provide greater supporting force when fitting into each inner cavity, which helps to improve the quality and reliability of the balloon part.

[0088] Specifically, balloon forming generally includes two stages: primary stretching and secondary stretching. Among them, primary stretching is the key step to stretch the tubular material into a preliminary shape, while secondary stretching is to adjust the size and shape of the balloon, as well as the wall thickness of different parts of the balloon to meet the actual requirements. The output air pressure value of the ventilation device before secondary stretching makes the balloon part to be formed located in the first inner cavity and the third inner cavity suspended.

[0089] Specifically, the fourth preset inner diameter ФB is the outer diameter of the distal catheter of the balloon part to be formed during the secondary stretching process, and is also the outer diameter of the tapered pipe section at the distal end of the balloon part connected to the distal catheter. Among them, the fourth preset inner diameter ФB is greater than the first preset inner diameter ФA. The fifth preset inner diameter ФD is the outer diameter of the proximal catheter of the balloon part to be formed during the secondary stretching process, and is also the outer diameter of the tapered pipe section at the proximal end of the balloon part connected to the proximal catheter. The fourth preset inner diameter is equal to the outer diameter of the distal catheter of the balloon part to be formed. Among them, the fifth preset inner diameter ФD is greater than the second preset inner diameter ФC, and the fifth preset inner diameter is equal to the outer diameter of the proximal catheter of the balloon part to be formed; in this embodiment, ФB is less than ФD, that is, the outer diameter of the distal catheter of the balloon part to be formed is less than the outer diameter of the proximal catheter.

[0090] Specifically, by adjusting the inner diameters of the first inner cavity and the third inner cavity and the temperatures of the distal mold 20 and the proximal mold 30, the distal catheter of the balloon part to be formed, part of the tapered pipe section at the distal end of the balloon part, the proximal catheter of the balloon part to be formed, and part of the tapered pipe section at the proximal end of the balloon part are fully softened by the first heating device and the second heating device and blown by the ventilation device. The balloon part to be formed fits into the first inner cavity and the third inner cavity during the secondary stretching process, thereby increasing the diameters of the balloon tapered part and the waist, reducing its wall thickness, and during the secondary stretching process, the middle working section is in a relatively cooled state, and the outer diameter hardly changes during the secondary stretching process, thereby improving the thickness uniformity of each part of the balloon and overcoming the problem of uneven wall thickness caused by secondary stretching.

[0091] S103 further includes:

[0092] Adjust the temperatures of the first heating device and the third heating device, and stretch the balloon part to be formed again until the tapered part and the waist part of the balloon part to be formed are in contact with the first inner cavity and the third inner cavity;

[0093] Specifically, after heating the distal mold 20 and the proximal mold 30 and performing secondary stretching of the balloon part to be formed, it includes reducing the temperature of the middle mold 10 to cool and shape part of the balloon part. At this time, the distal catheter of the balloon, the tapered part of the distal catheter, the proximal catheter of the balloon, the tapered part of the proximal catheter, and the balloon part are cooled and shaped.

[0094] S104. After cooling and shaping, a formed balloon part is obtained.

[0095] Specifically, after the balloon part to be formed is formed, turn on the balloon forming device and take out the formed balloon part.

[0096] The above are only the preferred embodiments of the present application and are not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A balloon forming device, comprising a distal mold (20) having a first inner cavity, an intermediate mold (10) having a second inner cavity, and a proximal mold (30) having a third inner cavity, which are connected in sequence, characterized in that: After the distal mold (20), the intermediate mold (10) and the proximal mold (30) are connected, the first inner cavity, the second inner cavity and the third inner cavity are in communication and can accommodate the balloon part to be formed; at least part of the first inner cavity accommodates the tapered pipe section at the distal end of the balloon part to be formed, and at least part of the third inner cavity accommodates the tapered pipe section at the proximal end of the balloon part to be formed; At least one of the distal mold (20) and the proximal mold (30) includes an adjusting mechanism, and by adjusting the adjusting mechanism, the inner diameter of at least one of the first inner cavity and the third inner cavity can be changed.

2. The balloon forming device according to claim 1, characterized in that It further includes a limit adjusting member; The limit adjusting member is in transmission connection with the adjusting mechanism to drive the adjusting mechanism to move, so as to form the first inner cavity or the third inner cavity with different inner diameters.

3. The balloon forming device according to claim 1, characterized in that The adjusting mechanism includes a plurality of adjusting flaps, and the plurality of adjusting flaps are adjacent to each other in sequence to enclose the first inner cavity or the third inner cavity; The plurality of adjusting flaps can rotate around the axis of the first inner cavity or the third inner cavity, and during the rotation, the adjusting flaps can approach or move away from the central axis of the first inner cavity in the radial direction, so as to increase or decrease the inner diameter of the first inner cavity or the third inner cavity.

4. The balloon forming device according to claim 3, characterized in that It further includes a first limiting plate and a second limiting plate; The first limiting plate is adjacent to the outer peripheral wall of the distal mold (20) and can limit the extreme position of the movement of the adjusting flap in the distal mold (20) away from the central axis; The second limiting plate is adjacent to the outer peripheral wall of the proximal mold (30) and can limit the extreme position of the movement of the adjusting flap in the proximal mold (30) away from the central axis.

5. The balloon forming device according to any one of claims 1 - 3, characterized in that It further includes a first heating device, a second heating device and a third heating device controlled by independent switches. The first heating device is arranged on the distal mold (20), the second heating device is arranged on the intermediate mold (10), and the third heating device is arranged on the proximal mold (30).

6. The balloon forming device according to any one of claims 1 - 3, characterized in that It further includes a first heat insulating member (40) and a second heat insulating member (50). The first heat insulating member (40) is arranged between the intermediate mold (10) and the distal mold (20), and the second heat insulating member (50) is arranged between the intermediate mold (10) and the proximal mold (30).

7. The balloon forming device according to any one of claims 1 - 3, characterized in that It further includes a distal mold seat (21) and a proximal mold seat (31). The distal mold seat (21) is connected to the distal mold (20), and the proximal mold seat (31) is connected to the proximal mold (30); The distal mold seat (21) and the proximal mold seat (31) are made of heat insulating materials, and the intermediate mold (10), the distal mold (20) and the proximal mold (30) are made of heat conducting materials.

8. The balloon forming device according to any one of claims 1 - 3, characterized in that The distal mold (20), the proximal mold (30) and the intermediate mold (10) are coaxially arranged.

9. A balloon forming method, which is applied to the balloon forming device according to any one of claims 1 - 8, characterized in that The method includes: Place the balloon part to be formed in the inner cavity of the balloon forming device. At least part of the tapered tube section at the distal end of the distal catheter and the balloon part of the balloon part to be formed is located in the first inner cavity, part of the balloon part is located in the second inner cavity, and at least part of the tapered tube section at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed is located in the third inner cavity; Adjust the adjustment mechanism so that the inner diameter value of the first inner cavity reaches a first preset inner diameter, and the inner diameter value of the third inner cavity reaches a second preset inner diameter. In the inflated state, stretch the balloon part to be formed until it fits against the first inner cavity, the second inner cavity, and the third inner cavity; Adjust the adjustment mechanism so that the inner diameter value of the first inner cavity reaches a fourth preset inner diameter, and the inner diameter value of the third inner cavity reaches a fifth preset inner diameter. In the inflated state, heat the distal mold (20) and the proximal mold (30) to perform secondary stretching of the balloon part to be formed until it fits against the first inner cavity, the second inner cavity, and the third inner cavity; the fourth preset inner diameter is greater than the first preset inner diameter, and the fifth preset inner diameter is greater than the second preset inner diameter; After cooling and shaping, a formed balloon part is obtained.

10. The balloon forming method according to claim 9, characterized in that Before adjusting the adjustment mechanism so that the inner diameter value of the first inner cavity reaches a fourth preset inner diameter and the inner diameter value of the third inner cavity reaches a fifth preset inner diameter, it further includes Reduce the output air pressure value of the ventilation device so that there is a gap between at least part of the tapered tube section at the distal end of the distal catheter and the balloon part of the balloon part to be formed and the inner wall of the first inner cavity, and there is a gap between at least part of the tapered tube section at the proximal end of the proximal catheter and the balloon part of the balloon part to be formed and the inner wall of the third inner cavity.

11. The balloon forming method according to claim 9, characterized in that Before heating the distal mold (20) and the proximal mold (30) to perform secondary stretching of the balloon part to be formed, it further includes Reduce the temperature of the intermediate mold (10) so that part of the balloon part is cooled and shaped.

Images