A vertebral body expansion balloon stretching and forming die and a forming method

Abstract

The present invention provides a stretching and forming die for a vertebral expansion balloon and a forming method thereof, including a stretching and forming die provided with a stretching and forming cavity, and a distal balloon forming die and a proximal balloon forming die respectively installed at the distal end and the proximal end of the stretching and forming die for forming the balloon. The distal balloon forming die and the proximal balloon forming die are detachably installed on the stretching and forming die. The stretching and forming die for the vertebral expansion balloon provided by the present invention has a simple structure, is convenient to assemble, has a high yield, and the obtained balloon has good uniformity. The present invention also provides a stretching and forming method for the vertebral expansion balloon, which has high processing efficiency and can realize the stretching and gas blowing forming of the balloon on traditional forming equipment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more specifically, to a stretching and forming mold for a vertebral expansion balloon. The present invention also relates to a stretching and forming method for a vertebral expansion balloon. Background Art

[0002] Osteoporotic vertebral compression fracture (OVCF) refers to the reduction of bone density and bone strength caused by osteoporosis, resulting in single or multiple vertebral compression fractures. In addition to osteoporosis, vertebral hemangioma or metastatic tumor, osteolytic vertebral fracture, and vertebral destruction caused by malignant bone tumor can also cause vertebral compression fracture.

[0003] Percutaneous kyphoplasty (PKP) is a procedure in which, under the guidance of C-arm fluoroscopy, a catheter is inserted into the vertebral body through an extra-pedicle approach, and a bone dilator (balloon) is inserted. The balloon is inflated to restore the vertebral height and form a cavity in the vertebral body, which is directly used for the filling of bone cement. In this way, the bone cement can be injected under low pressure, thus greatly reducing the risk of leakage.

[0004] Currently, the mainstream vertebral balloons in clinical practice mainly consist of a balloon body 01, a radiopaque ring 02, a catheter (composed of an outer tube 03 and an inner tube 04), a connector 05, a pre-set support wire 06, and a one-way valve / Luer connector 07, as Figure 1 shown, among which, the balloon body part is the core structure of the balloon, which directly affects the pressure resistance and burst safety of the expanded balloon.

[0005] However, the processing of vertebral balloons on the market usually requires first being drawn thinner and then inflated and shaped. Since the two processes need to be completed on two devices, the tube blank is first drawn thinner by a balloon stretching machine, and then the drawn thinner tube blank is placed in a balloon forming machine, the lumen is inflated, and it is shaped by a mold to complete the balloon forming on the tube blank. Using this processing method, the efficiency is low, the process flow is complex. Vertebral expansion balloons usually use compliant polyurethane elastomer materials. Due to the good rebound effect of the material, when using a balloon stretching machine to stretch the tube blank, it needs to be stretched and shaped for a long time. Even so, after the stretching is withdrawn, the balloon tube blank will retract, which affects the stability and uniformity of balloon production, and ultimately affects the qualified rate of the balloon. Summary of the Invention

[0006] The object of the present invention is to provide a stretching and forming mold for a vertebral expansion balloon, which can realize one-step stretching and forming on an ordinary balloon forming machine, reduce the production process, improve the production efficiency, reduce the production cost, and can avoid the retraction of the polyurethane elastomer tube blank after stretching, improve the qualified rate and uniformity of the product. The present invention also provides a stretching and forming method for a vertebral expansion balloon, with high processing efficiency, and can realize the stretching and air-blowing forming of the balloon on traditional forming equipment.

[0007] The present invention provides a stretching and forming die for a vertebral expansion balloon, including a stretching and forming die. The stretching and forming die is provided with a stretching and forming cavity for placing a tube blank and stretching and forming the tube blank on an external forming device. A distal balloon forming die and a proximal balloon forming die for forming a balloon are respectively installed at the distal end and the proximal end of the stretching and forming die. The distal balloon forming die and the proximal balloon forming die are respectively provided with a first balloon forming cavity and a second balloon forming cavity. The distal balloon forming die and the proximal balloon forming die are detachably installed on the stretching and forming die.

[0008] Preferably, the stretching and forming cavity includes a forming cavity body with an equal diameter and mounting chambers respectively arranged on both sides of the forming cavity body.

[0009] Preferably, both the distal balloon forming die and the proximal balloon forming die are split dies; the distal balloon forming die includes a distal upper die and a distal lower die, and the distal upper die and the distal lower die are fixed by a first connecting member;

[0010] The proximal balloon forming die includes a proximal upper die and a proximal lower die, and the proximal upper die and the proximal lower die are fixed by a second connecting member.

[0011] Preferably, the first connecting member and the second connecting member are locked by screws or magnetically connected.

[0012] Preferably, the first connecting member and the second connecting member are specifically fixed by the fitting of a clamping groove and a clamping block.

[0013] Preferably, the diameters at the joints of the conical cavities of the first balloon forming cavity and the second balloon forming cavity and the forming cavity body are equal.

[0014] The present invention also provides a stretching and forming method for a vertebral expansion balloon, including the steps of:

[0015] Placing the tube blank in the stretching and forming cavity of the stretching and forming die;

[0016] Placing the stretching and forming die carrying the tube blank on a balloon forming machine for stretching and forming operations, and stretching the tube blank to a preset distance;

[0017] Respectively installing the distal balloon forming die and the proximal balloon forming die at the proximal end and the distal end of the stretching and forming die to form a die body;

[0018] Placing the die body on the balloon forming machine for heating and blowing to form a balloon.

[0019] Preferably, the preset distance is 10 mm to 1000 mm.

[0020] Preferably, the balloon forming temperature is 120°C to 200°C.

[0021] Preferably, the balloon forming time is 10s to 300s.

[0022] Compared with the above background art, the vertebral expansion balloon stretching and forming die provided by the present invention adopts a three-section split design. The middle stretching and forming die is used to form the main body of the balloon. The proximal balloon forming die and the distal balloon forming die are used in combination with the stretching and forming die. When in use, without stretching, the tube blank is pre-penetrated into the middle stretching and forming die, and stretching operation is carried out on an external forming device until the target length is reached. Then, the distal balloon forming die and the proximal balloon forming die are installed. Finally, the tube blank is successively processed by heating and blowing using the external forming device to obtain the balloon. The vertebral expansion balloon stretching and forming die provided by the present application has a simple structure, is convenient to assemble, simplifies the processing steps of the vertebral expansion balloon, improves the processing efficiency, has a high yield rate, good uniformity, and is easy to realize the mass production of the vertebral expansion balloon. Description of the Drawings

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained according to the provided drawings without creative efforts.

[0024] Figure 1 Schematic diagram of a traditional vertebral balloon;

[0025] Figure 2 Schematic diagram of the vertebral expansion balloon stretching and forming die provided by the present invention;

[0026] Figure 3 For Figure 2 Cross-sectional view;

[0027] Figure 4 For Figure 2 Cross-sectional view of the stretching and forming die in

[0028] Figure 5 For Figure 2 Cross-sectional view of the proximal balloon forming die in

[0029] Figure 6 For Figure 2 Cross-sectional view of the distal balloon forming die in

[0030] Figure 7 Schematic diagram of the balloon forming machine applied with the vertebral expansion balloon stretching and forming die provided by the present invention.

[0031] Among them, 1 is a stretching and forming die, 2 is a distal balloon forming die, 3 is a proximal balloon forming die, 4 is a balloon forming machine, 5 is a pneumatic fixture, and 6 is a heating module;

[0032] 11 is a stretching and forming cavity, 21 is a first balloon forming cavity, and 31 is a second balloon forming cavity. Specific implementation manners

[0033] The core of the present invention is to provide a stretching and forming die for a vertebral expansion balloon, and the forming die has a simple structure and is convenient to use. Another core of the present invention is to provide a stretching and forming method for a vertebral expansion balloon processed by using the above-mentioned stretching and forming die for a vertebral expansion balloon, which can perform one-step stretching and forming on existing forming equipment, reduce production processes, improve production efficiency, reduce production costs, have a good finished product rate of the balloon, and have stable quality.

[0034] In order to enable those skilled in the art of the present technology to better understand the solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific implementation manners.

[0035] Please refer to Figures 2 to 7 , Figure 2 , which is a schematic diagram of the stretching and forming die for a vertebral expansion balloon provided by the present invention; Figure 3 is Figure 2 a cross-sectional view of Figure 4 is Figure 2 a cross-sectional view of the stretching and forming die in Figure 5 is Figure 2 a cross-sectional view of the proximal balloon forming die in Figure 6 is Figure 2 a cross-sectional view of the distal balloon forming die in Figure 7 , which is a schematic diagram of the balloon forming machine applied with the stretching and forming die for a vertebral expansion balloon provided by the present invention.

[0036] The present invention provides a stretching and forming die for a vertebral expansion balloon, particularly applicable to the forming die for the expandable balloon part in a vertebral expansion balloon catheter. It mainly includes a stretching and forming die 1, a distal balloon forming die 2, and a proximal balloon forming die 3. Inside the stretching and forming die 1, there is a stretching and forming cavity 11 for placing a tube blank. After the tube blank is placed in the stretching and forming cavity 11, the entire stretching and forming die 1 is placed on an external forming device, and the stretching and forming die 1 and the tube blank inside it are stretched and formed by the external forming device to reach an ideal stretching length, forming a balloon body. The distal end (i.e., the outer tube connection end) of the stretching and forming die 1 is detachably installed with the distal balloon forming die 2, and the proximal end (i.e., the inner tube connection end) of the stretching and forming die 1 is detachably installed with the proximal balloon forming die 3. The distal balloon forming die 2 and the proximal balloon forming die 3 are respectively provided with a first balloon forming cavity 21 and a second balloon forming cavity 31. After the tube blank is stretched and formed, the distal balloon forming die 2 and the proximal balloon forming die 3 are respectively installed at the proximal and distal ends of the stretching and forming die 1 to form an overall balloon die. Then, the overall balloon die is placed on an external forming device, and the tube blank is heated and inflated by the external forming device to form the tapered part of the balloon.

[0037] The tube blank material of the above-mentioned vertebral expansion balloon is preferably a thermoplastic elastomer, and it can also be materials such as thermoplastic polyurethane elastomer, nylon elastomer (PEBAX), and silicone.

[0038] In addition, the above-mentioned external forming device can specifically be a balloon forming machine 4, but it is not limited thereto.

[0039] As can be seen from the above, the forming die provided in this application adopts a three-section split structure, and the stretching and forming processes of the balloon are completed in one step on an external forming device, improving the processing and forming efficiency of the balloon. The balloon obtained by processing has a high yield, good quality, and uniformity.

[0040] In a specific embodiment, the above-mentioned stretching and forming cavity 11 includes a forming cavity body and two installation chambers, and the three cavities are interconnected.

[0041] The forming cavity body is an elongated and equal-diameter circular cross-section cavity. The specific dimensions of the forming cavity body are designed according to the dimensions of the original tube blank, and it should be ensured that it is easy to place the tube blank and avoid too much space reserved between the tube blank and the forming cavity body. The dimensions of the two installation chambers are generally equal, and they are both circular cross-section cavities with a diameter larger than that of the forming cavity body. The specific dimensions of the installation chambers are also set according to the tube blank dimensions. The two installation chambers are respectively arranged on both sides of the forming cavity body. The forming cavity body is used to place the tube blank, and the proximal balloon forming die 3 and the distal balloon forming die 2 are respectively inserted into the two installation chambers to realize the fixed installation of the two dies.

[0042] Both the above-mentioned first balloon forming cavity 21 and the second balloon forming cavity 31 are provided with tapered cavities to achieve the formation of the tapered part of the balloon. The specific dimensions of the tapered cavities are also designed according to actual needs.

[0043] To facilitate the handling of the tube blank, the distal balloon forming die 2 and the proximal balloon forming die 3 can be split-type dies. Specifically, the distal balloon forming die 2 includes a distal upper die and a distal lower die, and the distal upper die and the distal lower die are fixed by a first connecting member. Similarly, the proximal balloon forming die 3 includes a proximal upper die and a proximal lower die, and the proximal upper die and the proximal lower die are installed and fixed by a second connecting member.

[0044] The above-mentioned first connecting member and second connecting member can be connected by screwing, or can adopt the magnetic adsorption connection method of a magnet and a magnetic member, or can also adopt the combined connection method of magnetism and machinery.

[0045] In addition, the first connecting member and the second connecting member can also be fixed by the fitting of a clamping groove and a clamping block. After stretch forming, the diameter of the tube blank is smaller than the inner diameter of the balloon forming cavity. Assemble the proximal upper die and the proximal lower die and install them at the proximal end of the stretch forming die 1; then assemble the distal upper die and the distal lower die and install them at the distal end of the stretch forming die 1, and then perform the heating and blowing processes to process and form the balloon; after cooling and forming, open the die and take out the formed balloon.

[0046] Preferably, the inner diameter of the forming cavity body is 1 mm to 100 mm.

[0047] Preferably, the inner diameter of the tapered cavities of the first balloon forming cavity 21 and the second balloon forming cavity 31 is 1 mm to 100 mm.

[0048] To ensure the smooth connection between the balloon body and the balloon tapered part, it should be ensured that the diameters of the connections between the tapered cavities inside the distal balloon forming die 2 and the proximal balloon forming die 3 and the forming cavity body inside the stretch forming die 1 are equal, and it should be ensured that the connection is smoothly transitioned to avoid the occurrence of steps and ensure the forming quality.

[0049] In addition, the present invention also provides a method for stretch forming a vertebral expansion balloon, which is processed by using the above-mentioned vertebral expansion balloon stretch forming die 1, and includes the following steps:

[0050] Step 1: Place the tube blank in the stretch forming cavity 11 of the stretch forming die 1;

[0051] Step 2: Place the stretch forming die 1 carrying the tube blank on the balloon forming machine 4 for stretching and forming operations, and stretch the tube blank to a preset distance;

[0052] Step 3: Install the distal balloon forming die 2 and the proximal balloon forming die 3 at the proximal end and the distal end of the stretch forming die 1 respectively to form a die body;

[0053] Step 4: Place the mold body on the balloon forming machine 4 for heating and blowing to form a balloon.

[0054] Specifically, first place the tube blank in the middle stretching cavity 11 of the stretching mold 1, place the stretching mold 1 and the tube blank as a whole on the balloon forming machine 4, use the pneumatic clamp 5 to clamp the tube blank, and stretch the tube blank. Before stretching the tube blank, the tube blank can be heated by the heating module 6 of the balloon forming machine 4; after stretching and forming, then install the distal balloon forming mold 2 and the proximal balloon forming mold 3 to form the mold body, realizing the stretching and piercing of the tube blank into the mold process; finally, place the mold body on the balloon forming machine 4 for heating and blowing to form a balloon.

[0055] Through parameter setting, preferably, the preset distance for stretching the tube blank is 10 mm to 1000 mm, but it is not limited thereto.

[0056] Through parameter setting, preferably, the balloon forming temperature is 120°C to 200°C, but it is not limited thereto.

[0057] Through parameter setting, preferably, the balloon forming time is 10 s to 300 s, but it is not limited thereto.

[0058] The balloon forming method provided by this application can realize one-step stretching and forming on the existing balloon forming machine 4. On the one hand, it reduces the production process, improves production efficiency, and reduces production costs. On the other hand, it avoids the factors of retraction and instability after stretching of tube blanks made of materials such as polyurethane elastomers, ensures product quality, and improves the qualification rate and uniformity of products.

[0059] It should be noted that in this specification, relational terms such as first and second are only used to distinguish one entity from several other entities, and do not necessarily require or imply any such actual relationship or order between these entities.

[0060] The above has introduced in detail the vertebral expansion balloon stretching mold and the forming method provided by the present invention. Specific examples are used in this article to elaborate on the principle and implementation manner of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the principle of the present invention, several improvements and modifications can still be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims

1. A stretching and forming mold for a vertebral body expansion balloon, characterized in that, It includes a stretch forming die (1) which is provided with a stretch forming cavity (11) for placing a tube blank and stretch forming the tube blank on an external forming device. A distal balloon forming die (2) and a proximal balloon forming die (3) for forming a balloon are respectively installed at the distal end and the proximal end of the stretch forming die (1). The distal balloon forming die (2) and the proximal balloon forming die (3) are respectively provided with a first balloon forming cavity (21) and a second balloon forming cavity (31), and the distal balloon forming die (2) and the proximal balloon forming die (3) are detachably installed on the stretch forming die (1). The stretch forming cavity (11) includes an equal-diameter forming cavity body and mounting chambers respectively arranged on both sides of the forming cavity body; both the distal balloon forming die (2) and the proximal balloon forming die (3) are split dies; the distal balloon forming die (2) includes a distal upper die and a distal lower die, and the distal upper die and the distal lower die are fixed by a first connecting member; the proximal balloon forming die (3) includes a proximal upper die and a proximal lower die, and the proximal upper die and the proximal lower die are fixed by a second connecting member. The stretch forming die (1) is used to form the balloon body. During use, without stretching, the tube blank is pre-passed through the middle stretch forming die (1), and stretching operation is carried out on an external forming device until it is stretched to the target length. Then the distal balloon forming die (2) and the proximal balloon forming die (3) are installed, and finally the tube blank is heated and blown successively by the external forming device to obtain a balloon.

2. The vertebral expansion balloon stretching and forming die according to claim 1, wherein, The first connecting member and the second connecting member are attached by screwing or magnetically connected.

3. The vertebral body expansion balloon stretching and forming die according to claim 1, wherein, The first connecting member and the second connecting member are specifically fixed by the fitting of a card slot and a card block.

4. The vertebral expansion balloon stretching and forming die according to any one of claims 1 to 3, characterized in that The diameters at the joints of the conical cavities of the first balloon forming cavity (21) and the second balloon forming cavity (31) and the forming cavity body are equal.

5. A method for stretching and forming a vertebral body expansion balloon, characterized in that, Using the vertebral body expansion balloon stretch forming die according to any one of the above claims 1 to 4 to realize vertebral body expansion balloon stretch forming, including the steps: Place the tube blank in the stretch forming cavity (11) of the stretch forming die (1). Place the stretch forming die (1) carrying the tube blank on a balloon forming machine (4) for stretching and forming operations, and stretch the tube blank to a preset distance. Respectively install the distal balloon forming die (2) and the proximal balloon forming die (3) at the distal end and the proximal end of the stretch forming die (1) to form a die body. Place the die body on the balloon forming machine (4) for heating and blowing to form a balloon.

6. The vertebral body expansion balloon stretching and forming method according to claim 5, characterized in that The preset distance is 10 mm to 1000 mm.

7. The vertebral body expansion balloon stretching and forming method according to claim 5, wherein The balloon forming temperature is 120 °C to 200 °C.

8. The vertebral body expansion balloon stretching and forming method according to claim 5, wherein, The balloon forming time is 10 s to 300 s.

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