Double-layer balloon shaping mechanism

Abstract

The invention discloses a double-layer balloon shaping mechanism, and belongs to the technical field of medical instruments, the double-layer balloon shaping mechanism comprises a double-layer balloon and a vacuum shaping mold used for shaping, a support is installed outside the vacuum shaping mold, the double-layer balloon comprises an inner-layer balloon and an outer-layer balloon, the surface of the outer-layer balloon is provided with micropores used for controlling directional release of treatment substances, and the outer-layer balloon is provided with a support. The distribution density of the micropores is gradually reduced from the central area to the edge area, the vacuum shaping mold comprises an outer-layer mold and an inner-layer mold, the outer-layer mold and the inner-layer mold are respectively connected with an outer-layer end mold and an inner-layer end mold in a sealing manner, and the plurality of molds and the end molds are all provided with adsorption holes communicated with the interlayer; circular holes which are matched for use are formed in the contact surfaces of the mold and the end mold, the air conveying pipes of the outer-layer mold and the inner-layer mold are connected with a vacuum pump through pipelines, and a plurality of punching convex blocks are arranged on the inner cavity wall of the outer-layer mold. Precise release of the medicine is achieved through the micropores with the gradually decreased edges, and the micropores can be formed during vacuum adsorption.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a double-layer balloon shaping mechanism. Background Art

[0002] In the field of interventional medicine, balloon catheters are widely used in angioplasty and local drug delivery. The traditional double-layer balloon design aims to achieve vasodilation and targeted therapy simultaneously through the synergistic effect of the inner and outer layer structures. However, the existing technology still has significant defects in practical applications.

[0003] The outer micropores of existing double-layer balloons are mostly completed through secondary processing such as laser etching or mechanical punching. This process not only increases the production process and cost, but may also damage the balloon structure due to heat or mechanical stress. In addition, the micropore distribution is usually a uniform pattern, resulting in insufficient difference in the release amount of therapeutic substances in the lesion area and non-target area, making it difficult to accurately inhibit drug diffusion and easily causing side effects. Summary of the invention

[0004] The purpose of the present invention is to achieve accurate release of drugs through micropores with decreasing edges and enable the micropores to be formed while being vacuum-adsorbed.

[0005] In order to achieve the above-mentioned object, the present invention adopts the following technical scheme: a double-layer balloon shaping mechanism, comprising a double-layer balloon and a vacuum shaping mold for shaping, a bracket is installed outside the vacuum shaping mold, the double-layer balloon comprises an inner balloon and an outer balloon, the outer balloon surface is provided with micropores for controlling the directional release of therapeutic substances, and the distribution density of the micropores decreases from the central area to the edge area;

[0006] The vacuum shaping mold comprises an outer mold and an inner mold, the outer mold and the inner mold are respectively sealed and connected with an outer end mold and an inner end mold, a plurality of molds and end molds are provided with adsorption holes connected with the interlayer, and a contacting side of the mold and the end mold is provided with a circular hole for matching use, the air delivery pipes of the outer mold and the inner mold are connected with a vacuum pump through a pipeline, the inner cavity wall of the outer mold is provided with a plurality of punching convex blocks, and the outer end mold and the inner end mold are both fixed with mounting rods;

[0007] The bracket integrates a mold cooling module, a mold heating module and a sealing cover.

[0008] As a further description of the above technical solution: the contact surfaces of the outer layer mold and the inner layer mold with the outer layer end mold and the inner layer end mold are each provided with at least two sealing rings.

[0009] As a further description of the above technical solution: the air delivery pipe is connected to the interlayer of the outer mold and the inner mold, the mounting rod extends to the inner cavity of the outer mold and the inner mold, and the mounting rod adopts a retractable structure and can adjust the length according to the specifications of the balloon.

[0010] As a further description of the above technical solution: the mold cooling module is sleeved on the outside of the mold and the end mold, and is connected to the refrigerator on the bracket, and the mold cooling module is sealed and connected to the sealing cover.

[0011] As a further description of the above technical solution: the mold heating module is sleeved on the outer ring of the mold cooling module to achieve independent control of the heating and cooling functions.

[0012] As a further description of the above technical solution: the bracket is composed of a front mold and a rear mold fixed by bolts, the vacuum shaping mold is installed between the front mold and the rear mold, and the vacuum pump is fixed on the top of the bracket.

[0013] A manufacturing process for a double-layer balloon comprises the following steps:

[0014] a. Prepare preformed tubes for the inner layer balloon and the outer layer balloon, wherein the inner layer balloon is made of a medical material with high elasticity and low shrinkage rate, and the outer layer balloon is made of a biodegradable material;

[0015] b. Install the outer balloon in the outer mold, preheat it to a plastic state through the mold heating module, start the vacuum pump to adsorb the outer balloon to the inner wall of the mold, and simultaneously form micropores through the punching convex blocks;

[0016] c. Install the inner layer balloon in the inner layer mold, and preheat it through the mold heating module and then adsorb and shape it;

[0017] d. Cooling the inner and outer balloons after shaping through a mold cooling module to solidify the material structure;

[0018] e. The inner layer balloon and the outer layer balloon are coaxially assembled, and the ends are fixed by local heating and melting or adhesive to form a complete structure of the double-layer balloon.

[0019] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0020] 1. The micropores of the outer layer of the balloon are distributed in a pattern of dense center and gradually sparse edge. Combined with the punching bump design on the mold, the micropores can be formed during the vacuum adsorption process, thus eliminating the need for additional subsequent punching steps and avoiding potential damage to the balloon structure by secondary processing. At the same time, this design can effectively promote the efficient release of therapeutic substances in the target area and inhibit their diffusion in non-target areas, thereby significantly improving the treatment effect and reducing the risk of side effects.

[0021] 2. The outer mold and the inner mold are designed with independent end molds, adsorption holes and sandwich structures, so that the inner and outer balloons can be shaped in their respective optimal temperature control environments. At the same time, the sealing ring set between the mold and the end mold effectively improves the stability of vacuum adsorption, ensuring that the balloon can fit the inner wall of the mold evenly, avoiding deformation or uneven thickness problems.

[0022] 3. By adopting independent control methods of the mold heating module and the mold cooling module, precise shaping and rapid solidification of the balloon material can be achieved. The heating module preheats the balloon material before shaping to achieve the optimal plastic state, while the cooling module quickly cools down after shaping is completed to ensure the stable fixation of the balloon shape, thereby significantly improving the dimensional stability and long-term reliability of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A cross-sectional view of a vacuum shaping mold of the present invention is shown;

[0024] Figure 2 A cross-sectional view of the inner layer mold and the inner layer end mold of the present invention is shown;

[0025] Figure 3 A cross-sectional view of the outer layer mold and the outer layer end mold of the present invention is shown;

[0026] Figure 4 The present invention is shown Figure 3 The enlarged view of point A in the middle;

[0027] Figure 5 A three-dimensional diagram of the bracket and the vacuum shaping mold of the present invention is shown;

[0028] Figure 6 A cross-sectional view of a double-layer balloon of the present invention is shown;

[0029] Figure 7 The present invention is shown Figure 6 Enlarged view of point B in the middle.

[0030] Legend:

[0031] 10. Double-layer balloon; 11. Inner balloon; 12. Outer balloon; 121. Micropore; 13. Catheter; 14. Needle seat;

[0032] 20. Vacuum shaping mold; 21. Outer mold; 211. Punching convex block; 22. Inner mold; 23. Outer end mold; 24. Inner end mold; 25. Round hole; 26. Vacuum pump; 27. Air pipe; 28. Mounting rod; 29. ​​Sealing ring;

[0033] 30. Mold cooling module; 31. Mold heating module; 32. Sealing cover; 33. Refrigerator;

[0034] 40. Bracket; 41. Front mold; 42. Rear mold. DETAILED DESCRIPTION

[0035] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0036] See also Figure 1-Figure 7 The present invention provides a technical solution: a double-layer balloon shaping mechanism, comprising a double-layer balloon 10 and a vacuum shaping mold 20 for shaping, a bracket 40 is installed outside the vacuum shaping mold 20, the double-layer balloon 10 comprises an inner balloon 11 and an outer balloon 12, the inner balloon 11 is made of a medical material with high elasticity and low shrinkage rate to ensure that the balloon has a stable shape when inflated and expanded, and to avoid vascular damage caused by material deformation, the outer balloon 12 is made of a biodegradable material, and the degradable property reduces the potential risk of long-term residue in the body.

[0037] The surface of the outer balloon 12 is provided with micropores 121 for controlling the directional release of therapeutic substances. The distribution density of the micropores 121 decreases from the central area to the edge area, accurately controlling the release area of ​​the therapeutic substance (such as drugs or genes). The dense micropores 121 in the center ensure that the drug is released at a high concentration at the lesion site, and the sparse design at the edge inhibits diffusion in non-target areas, thereby improving the treatment effect and reducing side effects.

[0038] Furthermore, the outer balloon 12 is wrapped around the outside of the inner balloon 11, and the inner balloon 11 and the outer balloon 12 are sealed and fixed with the catheter 13 by high-frequency welding. The end of the catheter 13 is connected to the needle seat 14. The inner balloon 11 and the outer balloon 12 are sealed and connected to the catheter 13 by high-frequency welding to form a reliable drug delivery pathway to avoid leakage of therapeutic substances. The design of the needle seat 14 facilitates docking with external equipment, thereby improving the convenience of clinical operation.

[0039] The vacuum molding mold 20 includes an outer mold 21 and an inner mold 22. The outer mold 21 and the inner mold 22 are respectively used for independent molding of the outer balloon 12 and the inner balloon 11. The outer mold 21 and the inner mold 22 are respectively sealed and connected with an outer end mold 23 and an inner end mold 24. The outer mold 21 and the inner mold 22 are independently arranged, and molding parameters such as temperature and vacuum degree can be optimized according to the material properties of the outer balloon 12 and the inner balloon 11, so as to improve molding efficiency and finished product consistency.

[0040] The outer layer mold 21, the inner layer mold 22, the outer layer end mold 23 and the inner layer end mold 24 are all provided with interlayers inside, and the inner cavity walls of the outer layer mold 21, the inner layer mold 22, the outer layer end mold 23 and the inner layer end mold 24 are all provided with adsorption holes connected to the interlayers. The outer layer mold 21 and the outer layer end mold 23 are in contact with the inner layer mold 22 and the inner layer end mold 24. The surface is provided with a circular hole 25 for use with the inner layer mold 22 and the inner layer end mold 24. The outer layer mold 21 and the outer layer end mold 23 can be connected to the interlayer of the inner layer mold 22 and the inner layer end mold 24 through the circular hole 25. The air pipe 27 of the outer layer mold 21 and the inner layer mold 22 is connected to the vacuum pump 26 through a pipeline.

[0041] The inner wall of the outer layer mold 21 is provided with a plurality of punching bumps 211, and both the outer layer end mold 23 and the inner layer end mold 24 are fixed with mounting rods 28. The punching bumps 211 on the inner wall of the outer layer mold 21 simultaneously form micropores 121 during the adsorption process, thereby avoiding damage to the balloon structure by secondary processing and simplifying the process flow.

[0042] Furthermore, the contact surfaces of the outer mold 21 and the inner mold 22 with the outer end mold 23 and the inner end mold 24 are each provided with at least two sealing rings 29, and the sealing rings 29 enhance the air tightness between the mold and the end mold, prevent vacuum pressure leakage, and ensure stable adsorption effect.

[0043] Furthermore, the air supply pipe 27 is connected to the interlayer of the outer mold 21 and the inner mold 22, and the mounting rod 28 extends to the inner cavity of the outer mold 21 and the inner mold 22. The mounting rod 28 adopts a retractable structure and can adjust the length according to the specifications of the balloon. The retractable structure of the mounting rod 28 is adaptable to balloons of different specifications, thereby improving the versatility and production flexibility of the mold.

[0044] Furthermore, the bracket 40 integrates a mold cooling module 30, a mold heating module 31 and a sealing cover 32. The mold cooling module 30 is mounted on the outside of the mold and the end mold and is connected to the refrigerator 33 on the bracket 40. The mold cooling module 30 is sealed with the sealing cover 32. The mold cooling module 30 can quickly cool down and solidify the material after shaping, thereby avoiding rebound deformation caused by slow cooling and improving the dimensional stability of the balloon.

[0045] Furthermore, the mold heating module 31 is sleeved on the outer ring of the mold cooling module 30 to achieve independent control of the heating and cooling functions. The mold heating module 31 can preheat the balloon material to a plastic state, enhance the ductility of the material, and promote the fitting effect during vacuum adsorption.

[0046] Furthermore, the bracket 40 is composed of a front mold 41 and a rear mold 42 fixed by bolts, and the vacuum molding mold 20 is installed between the front mold 41 and the rear mold 42. The bracket 40 ensures that the vacuum molding mold 20 does not move during the molding process, thereby improving the molding accuracy. The vacuum pump 26 is fixed on the top of the bracket 40.

[0047] A manufacturing process for a double-layer balloon comprises the following steps:

[0048] a. preparing a preformed tube of an inner layer balloon 11 and an outer layer balloon 12, wherein the inner layer balloon 11 is made of a medical material with high elasticity and low shrinkage rate, and the outer layer balloon 12 is made of a biodegradable material;

[0049] b. Install the outer layer balloon 12 in the outer layer mold 21, preheat it to a plastic state through the mold heating module 31, start the vacuum pump 26 to absorb the outer layer balloon 12 to fit the inner wall of the mold, and simultaneously form micropores 121 through the punching bumps 211;

[0050] c. Install the inner layer balloon 11 in the inner layer mold 22, and preheat it through the mold heating module 31 and then adsorb and shape it;

[0051] d. Cooling the molded inner layer balloon 11 and the outer layer balloon 12 through the mold cooling module 30 to solidify the material structure;

[0052] e. The inner layer balloon 11 and the outer layer balloon 12 are coaxially assembled, and the ends are fixed by local heating and melting or adhesive to form a complete structure of the double-layer balloon 10.

[0053] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A double-layer balloon shaping mechanism, comprising a double-layer balloon (10) and a vacuum shaping mold (20) for shaping, wherein a bracket (40) is installed outside the vacuum shaping mold (20), characterized in that: The double-layer balloon (10) comprises an inner-layer balloon (11) and an outer-layer balloon (12), the outer-layer balloon (12) is provided with micropores (121) on its surface for controlling the directional release of therapeutic substances, and the distribution density of the micropores (121) decreases from the central area to the edge area; The vacuum shaping mold (20) comprises an outer mold (21) and an inner mold (22), the outer mold (21) and the inner mold (22) are respectively sealedly connected to an outer end mold (23) and an inner end mold (24), a plurality of molds and end molds are provided with adsorption holes communicating with the interlayer, and a contacting surface of the mold and the end mold is provided with a circular hole (25) for matching use, the air delivery pipes (27) of the outer mold (21) and the inner mold (22) are connected to a vacuum pump (26) through a pipeline, the inner cavity wall of the outer mold (21) is provided with a plurality of punching convex blocks (211), and the outer end mold (23) and the inner end mold (24) are both fixed with mounting rods (28); The support (40) integrates a mold cooling module (30), a mold heating module (31) and a sealing cover (32).

2. A double-layer balloon shaping mechanism according to claim 1, characterized in that: The outer balloon (12) is wrapped around the outside of the inner balloon (11), and the inner balloon (11) and the outer balloon (12) are both sealed and fixed with a catheter (13) by high-frequency welding, and the end of the catheter (13) is connected to a needle seat (14).

3. The double-layer balloon shaping mechanism and process method according to claim 1, characterized in that: The contact surfaces of the outer layer mold (21) and the inner layer mold (22) with the outer layer end mold (23) and the inner layer end mold (24) are each provided with at least two sealing rings (29).

4. The double-layer balloon shaping mechanism according to claim 1, characterized in that: The air delivery pipe (27) is connected to the interlayer of the outer mold (21) and the inner mold (22), and the mounting rod (28) extends to the inner cavity of the outer mold (21) and the inner mold (22). The mounting rod (28) adopts a retractable structure and can adjust the length according to the specifications of the balloon.

5. The double-layer balloon shaping mechanism according to claim 1, characterized in that: The mold cooling module (30) is sleeved on the outside of the mold and the end mold and connected to the refrigerator (33) on the bracket (40). The mold cooling module (30) is sealedly connected to the sealing cover (32).

6. A double-layer balloon shaping mechanism according to claim 1, characterized in that: The mold heating module (31) is sleeved on the outer ring of the mold cooling module (30) to achieve independent control of heating and cooling functions.

7. The double-layer balloon shaping mechanism and process method according to claim 1, characterized in that: The support (40) is composed of a front mold (41) and a rear mold (42) fixed by bolts, a vacuum shaping mold (20) is installed between the front mold (41) and the rear mold (42), and a vacuum pump (26) is fixed on the top of the support (40).

8. A manufacturing process for a double-layer balloon, characterized in that: The following steps are involved: (a) preparing a preformed tube of an inner balloon (11) and an outer balloon (12), wherein the inner balloon (11) is made of a medical material with high elasticity and low shrinkage rate, and the outer balloon (12) is made of a biodegradable material; (b) installing the outer layer balloon (12) in the outer layer mold (21), preheating it to a plastic state through the mold heating module (31), starting the vacuum pump (26) to absorb the outer layer balloon (12) to fit the inner wall of the mold, and simultaneously forming micropores (121) through the punching convex block (211); (c) installing the inner layer balloon (11) in the inner layer mold (22), and adsorbing and shaping it after preheating it through the mold heating module (31); (d) cooling the inner layer balloon (11) and the outer layer balloon (12) after being shaped by a mold cooling module (30) to solidify the material structure; (e) The inner layer balloon (11) and the outer layer balloon (12) are coaxially assembled, and the ends are fixed by local heating and melting or adhesive to form a complete structure of the double-layer balloon (10).

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