Tool for saccule pin and machining method of saccule pin

Abstract

The tool comprises an extrusion assembly, the extrusion assembly comprises at least two extrusion pieces capable of moving relatively, each extrusion piece is provided with a cavity, the cavities are filled with liquid media, and the liquid media are arranged in the cavities. The ends of the sides, close to each other, of the at least two extrusion pieces are each provided with a flexible extrusion part, after the at least two extrusion pieces make relative movement contact, all the flexible extrusion parts are closed to form an extrusion cavity, and the extrusion cavity can conduct extrusion forming on the balloon pin; the pressurizing part is movably arranged in the cavity so as to extrude the liquid medium, so that the flexible extrusion part is deformed; and the heating rod is arranged between the at least two extrusion pieces and can be positioned in the extrusion cavity. According to the tool, the sacculus pin is extruded through the flexible extrusion part, the forming process and the forming mode of the sacculus pin can be accurately controlled, and the controllability of the forming process of the sacculus pin is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a tooling for a balloon pin and a processing method thereof. Background Art

[0002] Balloon catheters are an important medical device in interventional treatment, and large-diameter balloons also occupy a large market. However, large-diameter balloons often have large inner diameters of the pins and thick pin walls, which poses great difficulties in the balloon-catheter connection process. If the balloon pins are too large and too thick, the flexibility and permeability of the balloon catheter will be poor, and the connection between the balloon pins and the catheter will be more difficult. Currently, common balloon-catheter connection methods on the market include laser welding, hot air welding, and glue bonding, but none of the above methods can overcome the disadvantages of balloon pins that are too large and too thick.

[0003] Therefore, it is necessary to provide a tool for processing the balloon pins so as to adjust the size of the balloon pins. Summary of the invention

[0004] Based on this, it is necessary to provide a tooling for a balloon tube pin to address the above-mentioned problems, comprising: an extrusion assembly, wherein the extrusion assembly comprises at least two relatively movable extrusion members, each of the extrusion members having a cavity, the cavity being filled with a liquid medium, and at least two of the extrusion members having ends close to each other being provided with a flexible extrusion portion, and after at least two of the extrusion members move relative to each other and come into contact, all of the flexible extrusion portions are closed to form an extrusion cavity, and the extrusion cavity can extrude and mold the balloon tube pin; a pressurizing portion, the pressurizing portion being movably arranged in the cavity to extrude the liquid medium to deform the flexible extrusion portion; a heating rod, which is arranged between at least two of the extrusion members and can be in the extrusion cavity, and the balloon tube pin can be sleeved on the heating rod.

[0005] Further, the extrusion piece includes an extrusion piece body formed with a cavity, the extrusion piece body includes an extrusion molding end with an opening, and the flexible extrusion portion includes a flexible film, and the flexible film is tightly connected to the extrusion molding end.

[0006] Furthermore, the flexible film is recessed toward the inside of the cavity to form an extrusion groove, and at least two of the extrusion grooves are closed to form the extrusion cavity.

[0007] Furthermore, the cross section of the extrusion groove is semicircular or semi-elliptical.

[0008] Furthermore, a plurality of the extrusion grooves are sequentially arranged from left to right, and the shapes of each of the extrusion grooves are the same or different.

[0009] Furthermore, the pressurizing part includes a piston assembly, and the piston assembly is slidably disposed in the cavity to squeeze the liquid medium.

[0010] Furthermore, a liquid inlet valve and a liquid outlet valve connected to the cavity are respectively provided on the left and right sides of the extrusion body.

[0011] Furthermore, the surface of the heating rod is coated with a coating, and the coating includes one or more of p-xylene, poly-p-xylene or PTEF.

[0012] The present invention also relates to a processing method for a balloon pin, which adopts the aforementioned tooling, and the method includes: sleeveing ​​a heat shrink tube on the outer periphery of the balloon pin, sleeve the balloon pin sleeved with the heat shrink tube on the heating rod; at least two of the extrusion members move relative to each other and contact to form an extrusion cavity, and the balloon pin is located in the extrusion cavity; the heating rod heats the balloon pin so that the balloon pin softens and the heat shrink tube shrinks; the pressurizing part squeezes the liquid medium from both sides to reduce the size of the extrusion cavity, and the extrusion cavity squeezes the heat shrink tube to further shrink it, and the balloon pin between the heat shrink tube and the heating rod is formed to a predetermined size and shape.

[0013] Furthermore, the heating rod heats the balloon tube pin including a first heating, the heating time of the first heating is 10-200s, and the heating temperature is 100-300°C; the pressurizing part squeezes the flexible extrusion part from both sides, including the pressurizing part gradually pressurizing the flexible extrusion part, the pressurizing rate is 0.2bar / s, and the target pressure is 1.5-5.0bar; the boiling point of the liquid medium is lower than the melting point of the flexible film of the flexible extrusion part.

[0014] The technical solution of the present invention has the following beneficial effects:

[0015] The tooling for the balloon catheter of the present invention adopts a semi-automatic balloon pin processing and forming method, which can improve the forming efficiency of the balloon catheter, reduce manual errors, and improve the product yield. In addition, a deformable flexible extrusion part is used to extrude the balloon pin, and the extrusion force of the flexible extrusion part can be accurately controlled by controlling the pressurization method of the pressurization part, so that the forming process and forming method of the balloon pin can be accurately controlled, and the controllability of the forming process of the balloon pin is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 A schematic structural diagram of a balloon foot tooling according to the first embodiment;

[0017] Figure 2 is a structural diagram of the balloon of the first embodiment;

[0018] Figure 3 for Figure 1 AA cross section in;

[0019] Figure 4 It is a structural schematic diagram of the pressurizing assembly in the first embodiment in an open state;

[0020] Figure 5 It is a structural schematic diagram of the pressurizing assembly in the first embodiment in a closed state;

[0021] Figure 6 for Figure 5 The main view;

[0022] Figure 7 It is a schematic structural diagram of the pressurizing assembly in the first embodiment squeezing the balloon pin;

[0023] Figure 8 Structural diagram of the extrusion part in the second embodiment. DETAILED DESCRIPTION

[0024] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0025] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "upper", "lower", "left", "right" and similar expressions used to indicate directions used herein are for illustrative purposes only and are not intended to be the only implementation method.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0027] It should be noted that, for medical devices, the end of the medical device that is relatively close to the operator is generally called the "proximal end", and the end of the medical device that is relatively far from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the delivery system are defined based on this principle, where "proximal end" and "distal end" are only used to describe the orientation, and do not only refer to the end face of the proximal end or the end face of the distal end; "axial" or "longitudinal axis" refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; "radial" or "transverse" refers to the direction perpendicular to the axial direction.

[0028] First embodiment

[0029] See also Figure 1 As shown, the present embodiment provides a tooling for a balloon pin, including: an extrusion assembly 20, wherein the extrusion assembly 20 includes two relatively movable extrusion pieces, namely a first extrusion piece 20a at the upper end side and a second extrusion piece 20b at the lower end side. Considering that the first extrusion piece 20a and the second extrusion piece 20b have basically the same structure, for the convenience of expression, the first extrusion piece 20a and the second extrusion piece 20b are collectively referred to as extrusion pieces in the present invention. Unless otherwise specified, no distinction is made between the two, and the extrusion piece refers to any one of the two. A heating rod 40 is provided between the first extrusion piece 20a and the second extrusion piece 20b. The heating rod 40 may be a metal piece or other material, such as a carbon rod or other heatable material. The heating rod 40 is used to heat the balloon pin to soften it, so as to facilitate subsequent molding.

[0030] In other embodiments, the extrusion assembly 20 may also include more than two relatively movable extrusion members, such as one or more extrusion members disposed at the top and one or more extrusion members disposed at the bottom. By disposing multiple extrusion members, the extrusion force of the extrusion assembly can be enhanced.

[0031] See also Figure 2 As shown, the balloon 50 in this embodiment includes a balloon body 52 and a balloon pin 51 arranged at one end of the balloon body 52. ​​One end of the balloon pin 51 is connected to the balloon body 52, and the other end is connected to a catheter (not shown in the figure) to form a balloon catheter. This embodiment mainly involves processing the balloon pin 51.

[0032] See also Figure 3As described above, the tooling for the balloon pin is further described. For ease of description, in this embodiment, the left and right sides are defined in the XX direction, the front and rear sides are defined in the YY direction, and the upper and lower sides are defined in the ZZ direction. The use of this orientation definition is only for the convenience of subsequent description and does not constitute any limitation on the scope of protection of the present invention. The extrusion member includes an extrusion member body 22, which is a cylindrical or rectangular parallelepiped structure with a cavity 24 with two ends open, and the open ends close to each other constitute an extrusion molding end, and a liquid medium is filled in the cavity 24. A flexible extrusion portion 23 is provided at the extrusion molding end of the two extrusion members. Among them, the liquid medium can be a mixture of one or more high-boiling point liquids such as water, oil, and ethylene glycol. The flexible extrusion portion 23 itself is deformable and covers the outer periphery of the balloon pin 51 to extrude it. The flexible extrusion portion 23 in this embodiment includes a flexible film, and the flexible film is sealed and connected at the end opening of the extrusion cavity. The flexible film can be made of flexible materials such as silicone, latex, and polyolefin. In addition, the flexible film is recessed toward the inner side of the cavity 24 to form an extrusion groove 27. The cross section of the extrusion groove 27 perpendicular to the YY direction is semicircular or semi-elliptical or other curved forms. Since the flexible film can be deformed freely, there is no specific restriction on its cross-sectional shape, as long as it can apply an extrusion force to the balloon tube pin. When the first extrusion member 20a and the second extrusion member 20b are separated from each other, their respective extrusion grooves 27 are also separated from each other. At this time, the extrusion assembly 20 is in an open state and does not constitute an extrusion cavity. When the first extrusion member 20a and the second extrusion member 20b are close to each other and contact each other, the extrusion grooves 27 of the first extrusion member 20a and the second extrusion member 20b are combined to form a closed cavity, which constitutes an extrusion cavity. At this time, the extrusion assembly 20 is in a closed state. In addition, a pressurizing portion 21 is slidably provided in the cavity 24 of the extrusion member body 22. The pressurizing portion 21 in this embodiment includes a piston assembly, which includes a piston and a piston rod connected to the piston, and the piston can be driven to move in the extrusion cavity by pushing the piston rod. The movement of the piston will squeeze the liquid medium, and then exert pressure on the flexible extrusion part 23 to deform it. For example, when the piston moves toward the direction close to the flexible extrusion part 23, the pressure of the liquid medium increases due to being squeezed, and the pressure will act on the flexible extrusion part 23 to expand it away from the piston. The expansion will reduce the size of the flexible extrusion part 23. Therefore, when the piston applies an extrusion force toward the direction close to the flexible extrusion part 23, the flexible extrusion part 23 will expand toward the outside of the cavity 24 due to the extrusion force, thereby reducing the size of the flexible extrusion part 23. The left and right sides of the extrusion body 22 are respectively provided with a liquid inlet valve 25 and a liquid outlet valve 26 connected to the cavity 24. The liquid inlet valve 25 and the liquid outlet valve 26 can be opened or closed respectively. When the liquid inlet valve 25 and the liquid outlet valve 26 are closed, the connection channel between the cavity 24 and the outside is closed, so that the fluid pressure in the cavity 24 can be maintained.When the inlet valve 25 is opened, liquid medium can be injected into the cavity 24 through the inlet valve 25; when the outlet valve 26 is opened, the liquid medium can flow out of the cavity 24 through the outlet valve 26. In this embodiment, the liquid medium in the cavity 24 can be exchanged with the liquid medium in the outside by providing the inlet valve 25 and the outlet valve 26.

[0033] See also Figure 4 As shown, when the balloon pin 51 needs to be processed, the first extrusion member 20a and the second extrusion member 20b are separated from each other, and the extrusion assembly 20 is in an open state to facilitate the installation of the balloon pin 51. When the extrusion assembly 20 is in an open state, the balloon pin 51 is sleeved on the heating rod 40. In order to reduce the friction between the heating rod 40 and the balloon pin 51 to facilitate installation, the outer peripheral surface of the heating rod 40 can be coated with a coating such as paraxylene, polyparaxylene or PTFE. When the balloon pin 51 is sleeved on the heating rod 40, since the heating rod 40 is between the first extrusion member 20a and the second extrusion member 20b, the balloon pin 51 is between the extrusion grooves 27 on the upper and lower sides.

[0034] See also Figure 5 As shown, when the first extrusion member 20a and the second extrusion member 20b are close to and in contact with each other, the extrusion grooves 27 on the first extrusion member 20a and the second extrusion member 20b will be spliced ​​and closed to form an extrusion cavity. At this time, the first extrusion member 20a and the second extrusion member 20b clamp the balloon pin 51 in the extrusion cavity.

[0035] See also Figure 6 As shown, the controller 10 is connected to the heating rod 40, the pressurizing part 30, the extrusion assembly 20, the liquid inlet valve 25, and the liquid outlet valve 26. The controller 10 can control the entire processing process of the tooling of the present invention. Specifically, for the heating rod 40, the controller 10 can control its heating time, temperature, heating or cooling mode; for the pressurizing part 30, the controller 10 can control the pressurization rate, target pressure, etc.; for the extrusion assembly 20, the controller can control the relative movement of the extrusion parts to realize the opening or closing of the extrusion assembly 20; for the liquid inlet valve 25 and the liquid outlet valve 26, the controller 10 can control their switch states.

[0036] See also Figure 7As shown, after the heating rod 40 heats the balloon pin 51 for a period of time to soften it, the pressure member 21 applies pressure to the balloon pin 51 from the upper and lower sides. For example, under the push of F1, the pressure member 21 at the top moves downward, and under the push of F2, the pressure member 21 at the bottom moves upward, thereby applying pressure to the liquid medium. The pressure applied by the pressure member 21 in the liquid medium will be transmitted to the flexible extrusion member 23 to cause the extrusion cavity to shrink inward, thereby achieving the extrusion of the balloon pin 51, making its inner diameter smaller and the thickness reduced.

[0037] The present invention also relates to a method for processing a balloon pin, which uses the above-mentioned tooling to process the balloon pin. During specific processing, the controller 10 controls the pressurizing component 20 to be in an open state, so that the extrusions on the upper and lower sides are separated, and the heating rod 40 is located between the two extrusions. Open the liquid inlet valve 25, close the liquid outlet valve 26, and inject liquid medium from the liquid inlet valve 25. According to the capacity of the extrusion body 22, 200 to 1000 ml of liquid medium can be injected. After the balloon pin 51 to be processed is sleeved on the heating rod 40, a heat shrink tube is sleeved on the outer periphery of the balloon pin 51 (not shown in the figure). Before processing, the balloon pin 51 has a pre-processing size, such as an inner diameter of 2.5 to 5.0 mm and a pin wall thickness of 0.5 to 2.00 mm. The first extrusion member 20a and the second extrusion member 20b are close to each other so that the extrusion assembly 20 is in a closed state. At this time, the balloon pin 51 is in the extrusion cavity, and the pressurizing part 21 does not apply pressure. The flexible film will change according to the shape of the pin. Since the outer side of the pin is covered with a heat shrink tube, the flexible film will be attached to the outer surface of the heat shrink tube. The heating rod 40 starts to work and implements the first heating. The heating time and heating temperature of the heating rod 40 are set according to the processing type, method, pin material, etc. that need to be processed. For example, the heating time is 10 to 200 seconds and the heating temperature is 100 to 300°C. Since the flexible film is also heated during the first heating, the boiling point of the liquid medium is set to be lower than the melting point of the flexible film. Since the flexible film is in direct contact with the liquid medium, the highest temperature that the flexible film can reach is the boiling point of the liquid medium, which is lower than the melting point of the flexible film, thereby ensuring that the flexible film can work normally during the heating process. The specific heating time and heating temperature are based on softening the balloon pin 51 to successfully complete the subsequent extrusion molding. For example, when the heating temperature is 200°C and the heating time is 50s, the balloon pin softens. When the balloon pin softens, the heat shrink tube will also begin to shrink due to the heat. After the balloon softens, the heating rod 40 performs a second heating. The second heating can be maintained at a temperature of 200°C for continued heating, or it can be reduced to another temperature, such as 150°C, and then the balloon pin is continued to be heated. When the balloon pin softens, the pressurizing part 21 begins to gradually pressurize. For example, the pressurization rate can be set to 0.2 bar / s, and the target pressure of pressurization can be set to 1.5 to 5.0 bar. In addition, the moving distance and speed of the piston assembly can also be set, such as setting the piston assembly downward pressure rate to 0.1 mm / s and the target displacement to 2 to 10 mm. When the pressurizing part 21 moves toward the target pressure or target displacement, the liquid medium squeezes the flexible film, and the flexible film deforms, thereby causing the extrusion cavity to shrink. The extrusion force generated by the contraction of the extrusion cavity will act on the balloon pin and the heat shrink tube at the same time, so that the heat shrink tube will further contract, making the wall thickness of the balloon pin thinner and the inner diameter smaller.When the pressurizing part 21 reaches the target pressure or target displacement, the inner diameter and wall thickness of the balloon pin will reach the required target values, for example, the inner diameter of the balloon pin before the diameter change is 4.0 mm and the wall thickness is 1.0 mm, and the inner diameter after being squeezed is 2.0 mm and the wall thickness is 0.2 mm. After the balloon pin 51 is reduced in diameter, the heating rod 40 stops heating, and the pressurizing part 21 starts to release pressure at this time, and the pressurizing part 21 no longer applies pressure to the liquid medium. After the pressurizing part 21 is depressurized, the liquid outlet valve 25 and the liquid inlet valve 26 are opened, and the liquid medium in the circulating cavity 24 begins, and the flowing liquid medium realizes rapid cooling of the processing area of ​​the balloon pin 51. After cooling for a period of time, the first extrusion member 20a and the second extrusion member 20b are controlled to separate from each other and the extrusion assembly 20 is converted into an open state. At this time, the processed balloon pin 51 is taken out, and the entire processing process is completed. During the above heating process, the shape of the balloon pin after extrusion molding is ensured by the heat shrink tube sleeved on the outside of the balloon pin and the heating rod inserted into the inside of the balloon pin. In the processing process, the heat shrink tube plays a role in shrinking and limiting the peripheral shape of the pin after softening, while the heating rod plays a role in limiting the shape of the inner wall of the pin after softening. Through the joint action of the heat shrink tube and the heating rod, the molding shape of the balloon pin between the heat shrink tube and the heating rod is limited, so that it has a predetermined shape after molding, such as a circular cross section.

[0038] Second embodiment

[0039] The tooling for the balloon catheter in this embodiment is basically the same as that in the first embodiment, except that the flexible extrusion portion of the extrusion piece in this embodiment is different from that in the first embodiment. Figure 8 As shown, the lower end of the extrusion body 822 of the extrusion piece is provided with a flexible extrusion portion 823, and the flexible extrusion portion 823 includes a flexible film, and the flexible film is recessed into the interior of the cavity 824 to form an extrusion groove 827. Among them, the extrusion groove 27 is sequentially provided with multiple ones from left to right, and the shape of each of the extrusion grooves is the same or different. Since the end of the extrusion piece in this embodiment is provided with multiple extrusion grooves 827, multiple extrusion cavities can be formed, and the extrusion piece with multiple extrusion cavities can process multiple balloon pins at the same time. When the extrusion groove 827 is set to different shapes, the extrusion piece can realize different requirements of processing for multiple balloon pins at one time, thereby improving processing efficiency and saving production costs.

[0040] The above-mentioned embodiments only express several implementation methods of the present invention, and the description is relatively specific and detailed, but it cannot be understood as limiting the scope of the invention patent. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. The protection scope of the patent of the present invention shall be based on the attached claims.

Claims

1. A tool for a balloon pin, characterized in that: include: An extrusion assembly, wherein the extrusion assembly comprises at least two extrusion members that can move relative to each other, each of the extrusion members having a cavity filled with a liquid medium, and at least two extrusion members are provided with a flexible extrusion portion at the ends of the mutually close sides, and after at least two extrusion members move relative to each other and come into contact, all the flexible extrusion portions are closed to form an extrusion cavity, and the extrusion cavity can extrude and shape the balloon pin; A pressurizing portion, the pressurizing portion being movably disposed in the cavity to press the liquid medium so that the flexible pressing portion is deformed; A heating rod is arranged between at least two of the extrusion members and can be located in the extrusion cavity, and the balloon pin can be sleeved on the heating rod.

2. The tooling for balloon pins according to claim 1, characterized in that: The extrusion piece comprises an extrusion piece body with a cavity formed therein, the extrusion piece body comprises an extrusion molding end with an opening, and the flexible extrusion portion comprises a flexible film, and the flexible film is tightly connected to the extrusion molding end.

3. The tooling for balloon pins according to claim 2, characterized in that: The flexible film is recessed toward the inside of the cavity to form an extrusion groove, and at least two of the extrusion grooves are closed to form the extrusion cavity.

4. The tooling for balloon pins according to claim 3, characterized in that: The cross section of the extrusion groove is semicircular or semi-elliptical.

5. The tooling for balloon pins according to claim 3, characterized in that: A plurality of extrusion grooves are arranged in sequence from left to right, and the shapes of each of the extrusion grooves are the same or different.

6. The tooling for balloon pins according to claim 1, characterized in that: The pressurizing part includes a piston assembly, and the piston assembly is slidably disposed in the cavity to press the liquid medium.

7. The tooling for balloon pins according to claim 2, characterized in that: A liquid inlet valve and a liquid outlet valve communicating with the cavity are respectively arranged on the left and right sides of the extrusion body.

8. The tooling for balloon pins according to claim 1, characterized in that: The surface of the heating rod is coated with a coating, and the coating includes one or more of p-xylene, poly-p-xylene or PTEF.

9. A method for processing a balloon pin, using the tooling according to any one of claims 1 to 8, the method comprising: Put a heat shrink tube on the outer periphery of the balloon pin, and put the balloon pin with the heat shrink tube on the heating rod; At least two of the extrusion members move relative to each other and contact each other to form an extrusion cavity, and the balloon pin is located in the extrusion cavity; The heating rod heats the balloon pins so that the balloon pins soften and the heat shrink tube shrinks; The pressurizing part squeezes the liquid medium from both sides to reduce the size of the extrusion cavity, and the extrusion cavity squeezes the heat shrinkable tube to further shrink it, and the balloon pin between the heat shrinkable tube and the heating rod is formed to a predetermined size and shape.

10. The processing method according to claim 9, characterized in that: The heating rod heats the balloon tube pin including the first heating, the heating time of the first heating is 10-200s, and the heating temperature is 100-300°C; the pressurizing part squeezes the flexible extrusion part from both sides, including the pressurizing part gradually pressurizing the flexible extrusion part, the pressurizing rate is 0.2bar / s, and the target pressure is 1.5-5.0bar; the boiling point of the liquid medium is lower than the melting point of the flexible film of the flexible extrusion part.

Images