A double-layer balloon sizing mechanism

Abstract

The application discloses a double-layer balloon shaping mechanism and belongs to the technical field of medical devices. The double-layer balloon shaping mechanism comprises a double-layer balloon and a vacuum shaping mold for shaping. A support is arranged 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 for controlling the directional release of therapeutic substances. The distribution density of the micropores decreases from the central region to the edge region. 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 sealedly connected with an outer-layer end mold and an inner-layer end mold. The outer-layer mold, the inner-layer mold, the outer-layer end mold and the inner-layer end mold are all provided with an inner interlayer. The inner cavities of the outer-layer mold, the inner-layer mold, the outer-layer end mold and the inner-layer end mold are all provided with adsorption holes which are in communication with the interlayer. Circular holes which are in communication with the interlayer are arranged on the contact surfaces of the outer-layer mold, the inner-layer mold, the outer-layer end mold and the inner-layer end mold. The application realizes the accurate release of drugs through the edge-decreasing micropores and enables the micropores to be shaped while being vacuum-adsorbed.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a double-layer balloon shaping mechanism. Background Technology

[0002] In the field of interventional medicine, balloon catheters are widely used for 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 layers. However, the existing technology still has significant shortcomings in practical applications.

[0003] The outer micropores of existing double-layer balloons are mostly completed through secondary processing using laser etching or mechanical drilling. Such processes not only increase production steps and costs, but may also damage the balloon structure due to thermal effects or mechanical stress. In addition, the micropore distribution is usually uniform, resulting in insufficient difference in the release of therapeutic substances between 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 this invention is to achieve precise drug release through micropores with decreasing edge diameter, and to enable the micropores to be formed simultaneously with vacuum adsorption.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a double-layer balloon shaping mechanism, comprising a double-layer balloon and a vacuum shaping mold for shaping, wherein a support is installed outside the vacuum shaping mold, the double-layer balloon comprises an inner balloon and an outer balloon, and the surface of the outer balloon is provided with micropores for controlling the directional release of therapeutic substances, wherein the distribution density of the micropores decreases from the central region to the edge region;

[0006] The vacuum forming mold includes an outer mold and an inner mold. The outer mold and the inner mold are respectively sealed and connected by an outer end mold and an inner end mold. The outer mold, the inner mold, the outer end mold and the inner end mold are all provided with an internal interlayer, and the inner cavity wall of each is provided with an adsorption hole that communicates with the interlayer.

[0007] The outer mold, inner mold, outer end mold and inner end mold are all provided with circular holes that connect the interlayer. The gas supply pipes of the outer mold and inner mold are connected to the vacuum pump through pipes. The inner cavity wall of the outer mold is provided with several perforated protrusions. The outer end mold and inner end mold are both fixed with mounting rods.

[0008] The bracket integrates a mold cooling module, a mold heating module, and a sealing cover. The mold cooling module is sleeved on the outside of the mold and the end mold and is connected to the refrigeration unit on the bracket. The mold cooling module is sealed to the sealing cover.

[0009] As a further description of the above technical solution: the outer balloon is wrapped around the inner balloon, and both the inner and outer balloons are sealed and fixed with catheters by high-frequency welding, with the end of the catheter connected to a needle hub.

[0010] As a further description of the above technical solution: the contact surfaces of the outer mold and the inner mold with the outer end mold and the inner end mold are each provided with at least two sealing rings.

[0011] As a further description of the above technical solution: the gas delivery pipe is connected to the interlayer of the outer mold and the inner mold, the mounting rod extends into the inner cavity of the outer mold and the inner mold, and the mounting rod adopts a telescopic structure that can adjust the length according to the balloon specifications.

[0012] As a further description of the above technical solution: the mold heating module is sleeved on the outer ring of the mold cooling module, so as to realize independent control of heating and cooling functions.

[0013] As a further description of the above technical solution: the bracket is composed of a front mold and a rear mold fixed by bolts, a vacuum forming mold is installed between the front mold and the rear mold, and a vacuum pump is fixed to the top of the bracket.

[0014] A manufacturing process for a double-layered balloon includes the following steps:

[0015] a. Pre-formed tubing for preparing inner and outer balloons, wherein the inner balloon is made of medical material with high elasticity and low shrinkage rate, and the outer balloon is made of biodegradable material;

[0016] b. Install the outer balloon preformed tubing into the outer mold, preheat it to a plastic state through the mold heating module, start the vacuum pump to adsorb the outer balloon preformed tubing to fit the inner wall of the mold, and simultaneously form micropores through the perforating protrusions.

[0017] c. The inner balloon preformed tubing is installed in the inner mold, and then preheated by the mold heating module and adsorbed and shaped.

[0018] d. The mold cooling module cools and solidifies the inner and outer balloons after they have been shaped, thus solidifying the material structure.

[0019] e. The inner and outer balloons are coaxially assembled, and the ends are fixed by local heating and melting or adhesive to form a complete structure of double-layer balloons.

[0020] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0021] 1. The micropores of the outer balloon are distributed in a pattern of dense distribution at the center and gradually sparse distribution at the edges. Combined with the perforation protrusion design on the mold, the micropores can be formed during the vacuum adsorption process, thus eliminating the need for additional subsequent perforation processes and avoiding potential damage to the balloon structure caused 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 therapeutic effect and reducing the risk of side effects.

[0022] 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 under their respective optimal temperature control environment. 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 evenly against the inner wall of the mold and avoid problems such as deformation or uneven thickness.

[0023] 3. By adopting an independent control method for the mold heating module and the mold cooling module, precise shaping and rapid curing of the balloon material can be achieved. The heating module preheats the balloon material before shaping to bring it to the optimal plastic state, while the cooling module rapidly cools it down after shaping to ensure the stable fixation of the balloon shape, thereby significantly improving the dimensional stability and long-term reliability of the balloon. Attached Figure Description

[0024] Figure 1 A cross-sectional view of the vacuum shaping mold of the present invention is shown;

[0025] Figure 2 A cross-sectional view of the inner layer mold and the inner layer end mold of the present invention is shown;

[0026] Figure 3 A cross-sectional view of the outer mold and the outer end mold of the present invention is shown;

[0027] Figure 4 The present invention is shown. Figure 3 Enlarged view of point A in the middle;

[0028] Figure 5 A perspective view of the bracket and vacuum forming mold of the present invention is shown;

[0029] Figure 6 A cross-sectional view of the double-layered balloon of the present invention is shown;

[0030] Figure 7 The present invention is shown. Figure 6 Enlarged view of point B in the middle.

[0031] Legend:

[0032] 10. Double-layered balloon; 11. Inner balloon; 12. Outer balloon; 121. Micropore; 13. Catheter; 14. Needle hub;

[0033] 20. Vacuum forming mold; 21. Outer layer mold; 211. Drilling protrusion; 22. Inner layer mold; 23. Outer layer end mold; 24. Inner layer end mold; 25. Round hole; 26. Vacuum pump; 27. Gas supply pipe; 28. Mounting rod; 29. ​​Sealing ring;

[0034] 30. Mold cooling module; 31. Mold heating module; 32. Sealing cover; 33. Refrigeration unit;

[0035] 40. Bracket; 41. Front mold; 42. Rear mold. Detailed Implementation

[0036] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Please see Figures 1-7 The present invention provides a technical solution: a double-layer balloon shaping mechanism, including a double-layer balloon 10 and a vacuum shaping mold 20 for shaping. A bracket 40 is installed on the outside of the vacuum shaping mold 20. The double-layer balloon 10 includes an inner balloon 11 and an outer balloon 12. The inner balloon 11 is made of medical material with high elasticity and low shrinkage rate to ensure the stability of the balloon shape when it is inflated and expands, and to avoid vascular damage caused by material deformation. The outer balloon 12 is made of biodegradable material, and the biodegradable characteristics reduce the potential risk of long-term residue in the body.

[0038] The outer balloon 12 has micropores 121 on its surface for controlling the targeted release of therapeutic substances. The distribution density of the micropores 121 decreases from the central region to the peripheral region, which precisely controls the release area of ​​therapeutic substances (such as drugs or genes). The dense micropores 121 in the center ensure high concentration release of drugs at the lesion site, while the sparse design at the edges inhibits diffusion in non-target areas, thereby improving the therapeutic effect and reducing side effects.

[0039] Furthermore, the outer balloon 12 is wrapped around the inner balloon 11. Both the inner balloon 11 and the outer balloon 12 are sealed and fixed with catheters 13 by high-frequency welding. The end of the catheter 13 is connected to the needle hub 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 and avoid leakage of therapeutic substances. The design of the needle hub 14 facilitates docking with external instruments and improves the convenience of clinical operation.

[0040] The vacuum shaping mold 20 includes an outer mold 21 and an inner mold 22. The outer mold 21 and the inner mold 22 are used for the independent shaping of the outer balloon 12 and the inner balloon 11, respectively. The outer mold 21 and the inner mold 22 are respectively sealed and connected to an outer end mold 23 and an inner end mold 24. The outer mold 21 and the inner mold 22 are set independently, and the shaping parameters, such as temperature and vacuum degree, can be optimized according to the material characteristics of the outer balloon 12 and the inner balloon 11, thereby improving the shaping efficiency and the consistency of the finished product.

[0041] The outer mold 21, inner mold 22, outer end mold 23 and inner end mold 24 are all provided with a sandwich layer. The inner wall of the outer mold 21, inner mold 22, outer end mold 23 and inner end mold 24 are all provided with adsorption holes that communicate with the sandwich layer. The outer mold 21 and outer end mold 23 are provided with matching round holes 25 on the side that contacts the inner mold 22 and inner end mold 24. The sandwich layer between the outer mold 21 and outer end mold 23 and the inner mold 22 and inner end mold 24 can be connected through the round holes 25 respectively. The gas supply pipes 27 of the outer mold 21 and inner end mold 22 are connected to the vacuum pump 26 through pipes.

[0042] The inner wall of the outer mold 21 is provided with several perforated protrusions 211. Both the outer end mold 23 and the inner end mold 24 are fixed with mounting rods 28. The perforated protrusions 211 on the inner wall of the outer mold 21 simultaneously form micropores 121 during the adsorption process, avoiding damage to the balloon structure during secondary processing and simplifying the process flow.

[0043] 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. The sealing rings 29 enhance the airtightness between the mold and the end mold, prevent vacuum pressure leakage, and ensure stable adsorption effect.

[0044] Furthermore, the gas delivery pipe 27 is connected to the interlayer of the outer mold 21 and the inner mold 22, and the mounting rod 28 extends into the inner cavity of the outer mold 21 and the inner mold 22. The mounting rod 28 adopts a telescopic structure that can adjust the length according to the balloon specifications. The telescopic structure of the mounting rod 28 is adapted to balloons of different specifications, improving the versatility of the mold and the flexibility of production.

[0045] 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 fitted outside the mold and end mold and connected to the refrigerator 33 on the bracket 40. The mold cooling module 30 is sealed to the sealing cover 32. The mold cooling module 30 can quickly cool down and solidify the material after shaping, avoiding rebound deformation caused by slow cooling and improving the dimensional stability of the balloon.

[0046] Furthermore, the mold heating module 31 is fitted around the outer ring of the mold cooling module 30, enabling independent control of the heating and cooling functions. The mold heating module 31 can preheat the balloon material to a plastic state, enhance the material's ductility, and promote the bonding effect during vacuum adsorption.

[0047] Furthermore, the bracket 40 is composed of a front mold 41 and a rear mold 42 fixed together by bolts. The vacuum forming mold 20 is installed between the front mold 41 and the rear mold 42. The bracket 40 ensures that the vacuum forming mold 20 does not shift during the forming process, thereby improving the forming accuracy. The vacuum pump 26 is fixed to the top of the bracket 40.

[0048] A manufacturing process for a double-layered balloon includes the following steps:

[0049] a. Pre-formed tubing for preparing inner balloon 11 and outer balloon 12, wherein the inner balloon 11 is made of medical material with high elasticity and low shrinkage rate, and the outer balloon 12 is made of biodegradable material;

[0050] b. Install the outer balloon preformed tubing into the outer mold 21, preheat it to a plastic state through the mold heating module 31, start the vacuum pump 26 to adsorb the outer balloon preformed tubing to fit the inner wall of the mold, and simultaneously form micropores 121 through the perforating protrusions 211.

[0051] c. The inner balloon preformed tubing is installed in the inner mold 22, and then preheated by the mold heating module 31 and adsorbed and shaped.

[0052] d. The mold cooling module 30 cools the shaped inner balloon 11 and outer balloon 12 to solidify the material structure.

[0053] e. The inner balloon 11 and the outer 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.

[0054] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection 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 mounted on the outside of the vacuum shaping mold (20), characterized in that: The double-layer balloon (10) includes an inner balloon (11) and an outer balloon (12). 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 region to the edge region. The vacuum forming mold (20) includes an outer mold (21) and an inner mold (22). The outer mold (21) and the inner mold (22) are respectively sealed and connected to an outer end mold (23) and an inner end mold (24). The outer mold (21), the inner mold (22), the outer end mold (23) and the inner end mold (24) are all provided with an internal interlayer, and their inner cavity walls are all provided with adsorption holes that communicate with the interlayer. The outer mold (21), inner mold (22), outer end mold (23) and inner end mold (24) are all provided with circular holes (25) that connect the interlayer. The gas supply pipes (27) of the outer mold (21) and inner mold (22) are connected to the vacuum pump (26) through pipes. The gas supply pipes (27) are connected to the interlayer of the outer mold (21) and inner mold (22). The inner wall of the outer mold (21) is provided with several perforated protrusions (211). The outer end mold (23) and inner end mold (24) are both fixed with mounting rods (28). The mounting rods (28) extend into the inner cavity of the outer mold (21) and inner mold (22). The mounting rods (28) adopt a telescopic structure and can adjust the length according to the balloon specifications. The bracket (40) integrates a mold cooling module (30), a mold heating module (31), and a sealing cover (32).

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

3. The double-layer balloon shaping mechanism according to claim 1, characterized in that: 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).

4. 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 end mold and connected to the refrigerator (33) on the bracket (40). The mold cooling module (30) is sealed to the sealing cover (32).

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

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

7. A manufacturing process for a double-layered balloon with a shaping mechanism as described in claims 1-6, characterized in that: Includes the following steps: (a) Pre-formed tubing for inner balloon (11) and outer balloon (12), wherein the inner balloon (11) is made of medical material with high elasticity and low shrinkage rate, and the outer balloon (12) is made of biodegradable material; (b) The outer balloon preformed tubing is installed in the outer mold (21), preheated to a plastic state by the mold heating module (31), and the vacuum pump (26) is started to adsorb the outer balloon preformed tubing to fit the inner wall of the mold, and micropores (121) are formed simultaneously by the perforating protrusion (211). (c) The inner balloon preformed tubing is installed in the inner mold (22), and then preheated by the mold heating module (31) and adsorbed and shaped. (d) The inner balloon (11) and outer balloon (12) after shaping are cooled by the mold cooling module (30) to solidify the material structure; (e) The inner balloon (11) and the outer 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 balloon (10).

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