Woven balloon

Abstract

The utility model relates to a woven balloon, belongs to the technical field of medical instruments, and solves the problem that the existing woven balloon is poor in flexibility. A woven balloon is composed of an inner tube, a developing ring, a curing coating, a woven mesh, a push rod, a stress diffusion tube and a catheter seat. The developing ring is fixed on the inner pipe through bonding or forging and pressing; the curing coating wraps the woven mesh; the stress diffusion pipe is sleeved on the push rod; the two ends of the inner pipe, the two ends of the curing coating and the two ends of the woven mesh are connected. One end of the pushing rod is connected with one end of the woven mesh, and the other end of the pushing rod is connected with the catheter seat. The woven balloon does not contain a lining balloon, and the thickness of the woven balloon is reduced, so that the woven balloon is softer, and the flexibility of the woven balloon is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a braided balloon. Background Art

[0002] Balloon catheters have been developed for decades and are widely used across various medical departments, primarily for dilating stenotic lesions. Balloons used for dilating stenotic lesions can be categorized into standard-pressure and high-pressure balloons based on the pressure they can withstand. They can also be categorized into compliant, semi-compliant, and non-compliant balloons based on the change in diameter as pressure increases.

[0003] Generally, balloons are blow-molded from tubes. The compliance and bursting pressure of the balloon are related to the material selection and the design of the balloon tube. The pressure resistance and compliance of the balloon can be increased by modifying the material, such as double-layer co-extrusion, triple-layer co-extrusion, etc. However, simple material modification has a limited effect on the performance of the material and cannot achieve a major leap. In order to enable the balloon to achieve a higher bursting pressure and lower compliance, the balloon can be processed subsequently. For example, a layer of dense mesh braided wire is woven on the surface of the balloon to restrain the increase in the diameter and elongation of the balloon, which can simultaneously achieve the effect of increasing the pressure resistance of the balloon and reducing the compliance of the balloon. Patent Nos. CN110290828A and CN109562247B both mention bonding a layer of fiber woven mesh on the outer surface or inner surface of the balloon to enhance the pressure resistance of the balloon and reduce the compliance of the balloon.

[0004] Existing technologies require bonding the inner lining balloon, the braided layer, and the adhesive layer attached to the inner lining balloon and the braided layer together, forming a single, integrated structure. This reduces the overall flexibility of the balloon. Because the three layers are fused together, the resulting balloon's wall thickness and overall stiffness are significantly greater than those of a simple inner lining balloon. This results in a stiffer balloon, larger size after folding, and a reduced ability to bend diseased blood vessels through the human body. Therefore, the structure of braided balloons requires optimization and improvement. Utility Model Content

[0005] In view of the above analysis, the embodiment of the present invention aims to provide a braided balloon to solve the problem of poor flexibility of existing braided balloons.

[0006] The purpose of this utility model is mainly achieved through the following technical solutions:

[0007] The present invention provides a braided balloon, which is composed of an inner tube (1), a developing ring (2), a curing coating (3), a braided mesh (4), a pushing rod (5), a stress diffusion tube (6) and a catheter seat (7);

[0008] The developing ring (2) is fixed on the inner tube (1) by bonding or forging;

[0009] The solidified coating (3) wraps the woven mesh (4);

[0010] The stress diffusion tube (6) is sleeved on the push rod (5);

[0011] The inner tube (1), the cured coating (3) and the braided mesh (4) are respectively connected at both ends;

[0012] One end of the pushing rod (5) is connected to one end of the braided mesh (4), and the other end of the pushing rod (5) is connected to the catheter seat (7).

[0013] Furthermore, the braided balloon does not contain a lining balloon.

[0014] Furthermore, the inner tube (1) and the push rod (5) are both catheters of equal diameter, each comprising a distal end, a proximal end, and a transition section.

[0015] Furthermore, the braided mesh (4) is composed of axial fiber filaments and radial fiber filaments intersecting each other at a certain angle, the angle ranging from 0 to 180 degrees, and the braided mesh (4) includes a distal end, a proximal end and a transition section.

[0016] Furthermore, the solidified coating (3) comprises a distal end, a proximal end and a transition section;

[0017] The stress diffusion tube (6) is a variable diameter conduit, comprising a proximal end, a distal end and a gradual section.

[0018] Furthermore, the catheter seat (7) comprises a filling cavity (8), a guidewire cavity (9), a first arc-shaped tube (10), a second arc-shaped tube (11), and a third arc-shaped tube (12).

[0019] Furthermore, the filling cavity (8) and the guidewire cavity (9) are both variable diameter catheters, each comprising a proximal end, a distal end and a gradient section.

[0020] Furthermore, the filling cavity (8) is obliquely arranged on the guide wire cavity (9), and the distal end of the filling cavity is connected to the guide wire cavity through a hole arranged in the middle section of the guide wire cavity gradient section;

[0021] The angle between the distal end of the filling cavity and the gradient section close to the distal end of the guide wire cavity is 40-70 degrees.

[0022] Furthermore, the two ends of the first arc-shaped tube (10) are respectively connected to the filling cavity gradient section and the distal end of the guidewire cavity, the two ends of the second arc-shaped tube (11) are respectively connected to the filling cavity gradient section and the proximal end of the guidewire cavity, and the two ends of the third arc-shaped tube (12) are respectively connected to the proximal end and the distal end of the guidewire cavity.

[0023] Furthermore, the distal end of the push rod is connected to the distal end of the braided mesh of the bonding coating machine, and the proximal end of the push rod is connected to the distal end of the guidewire cavity in the catheter seat.

[0024] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0025] 1. The braided balloon of the present invention includes an inner tube, a developing ring, a curing coating, a braided mesh 4, a push rod, a stress diffusion tube and a catheter seat. Compared with the existing braided balloon, it does not contain a lining balloon, which reduces the thickness of the braided balloon, making the braided balloon softer and improving the flexibility of the braided balloon.

[0026] 2. The bursting pressure and compliance of the braided balloon itself are mainly related to the braided layer. Therefore, when the lining balloon is removed, the bursting performance and compliance of the braided balloon will not be affected. The braided balloon of the utility model improves the flexibility of the braided balloon while ensuring the bursting performance and compliance.

[0027] In the present invention, the above-mentioned technical solutions can be combined with each other to achieve more preferred combination solutions. Other features and advantages of the present invention will be described in the subsequent description, and some advantages will become apparent from the description or be understood through practice of the present invention. The objectives and other advantages of the present invention can be achieved and obtained through the contents particularly pointed out in the description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings are only used for the purpose of illustrating specific embodiments and are not to be considered as limiting the present invention. Throughout the accompanying drawings, the same reference symbols denote the same components.

[0029] Figure 1 This is a schematic diagram of the braided balloon of the present invention.

[0030] Reference numerals:

[0031] 1-inner tube; 2-developing ring; 3-curing coating; 4-braided mesh; 5-push rod; 6-stress diffusion tube; 7-catheter seat; 8-filling cavity; 9-guidewire cavity; 10-first arc tube; 11-second arc tube; 12-third arc tube. DETAILED DESCRIPTION

[0032] The preferred embodiments of the present invention are described in detail below in conjunction with the accompanying drawings, wherein the accompanying drawings constitute a part of this application and are used together with the embodiments of the present invention to illustrate the principles of the present invention, and are not used to limit the scope of the present invention.

[0033] The utility model provides a braided balloon, comprising an inner tube 1, a developing ring 2, a curing coating 3, a braided mesh 4, a pushing rod 5, a stress diffusion tube 6 and a catheter seat 7;

[0034] The inner tube 1 and the push rod 5 are both catheters of equal diameter, each comprising a distal end, a proximal end and a transition section;

[0035] The developing ring 2 is fixed to the inner tube 1 by bonding or forging;

[0036] The woven mesh 4 is composed of axial fiber filaments and radial fiber filaments that cross each other at a certain angle, and the angle range is 0-180°. The overall shape of the woven mesh 4 can be the same as the existing liner balloon in an expanded state of any shape; the woven mesh 4 includes a distal end, a proximal end and a transition section; wherein the fiber filaments have a fineness of 10D-200D. If the fineness is too low, the bursting pressure of the woven balloon will be insufficient, and if it is too high, the woven balloon will be too thick and too hard.

[0037] The cured coating 3 wraps around the braided mesh 4, including a distal end, a proximal end, and a transition section;

[0038] The stress diffusion tube 6 is a variable diameter conduit, which is sleeved on the push rod 5 and includes a proximal end, a distal end and a gradient section;

[0039] The catheter seat 7 includes a filling cavity 8, a guidewire cavity 9, a first arc-shaped tube 10, a second arc-shaped tube 11, and a third arc-shaped tube 12. The filling cavity 8 and the guidewire cavity 9 are both variable diameter catheters, each including a proximal end, a distal end, and a gradient section; the filling cavity 8 is obliquely arranged on the guidewire cavity 9, and the distal end of the filling cavity 8 is connected to the guidewire cavity 9 through a hole provided in the middle section of the gradient section of the guidewire cavity; the angle between the distal end of the filling cavity 8 and the gradient section near the distal end of the guidewire cavity is 40-70°; the two ends of the first arc-shaped tube 10 are respectively connected to the filling cavity gradient section and the distal end of the guidewire cavity, the two ends of the second arc-shaped tube 11 are respectively connected to the filling cavity gradient section and the proximal end of the guidewire cavity, and the two ends of the third arc-shaped tube 12 are respectively connected to the proximal end and distal end of the guidewire cavity;

[0040] The distal end of the inner tube 1, the distal end of the cured coating, and the distal end of the braided mesh are bonded or welded together; the proximal end of the inner tube 1, the proximal end of the cured coating, and the proximal end of the braided mesh are bonded or welded together; the distal end of the push rod and the distal end of the braided mesh of the bonding coating machine are bonded or welded together, and the proximal end of the push rod is connected to the distal end of the guidewire cavity in the catheter seat.

[0041] The function of the developing ring 2 is to develop images in the body to help doctors determine the position of the braided balloon; the inner tube 1 is used to provide a passage for the guide wire, the curing coating 3 and the braided mesh 4 can expand the vascular embolism, the push rod 5 can deliver the braided balloon to the lesion site, the stress diffusion tube 6 can buffer the stress exerted on the push rod 5, and the catheter seat 7 is used to inflate the braided balloon, wherein the guide wire cavity 9 is used to provide a passage for the guide wire, and the filling cavity 8 is used for ventilation.

[0042] It should be noted that the distal ends of the filling cavity and guidewire cavity in the inner tube 1, curing coating 3, braided mesh 4, push rod 5, stress diffusion tube 6, and catheter seat 7 refer to the end of the braided balloon farthest from the operator, and the proximal ends refer to the end of the braided balloon closest to the operator. The part between the distal and proximal ends is called the transition section or gradient section.

[0043] The braided balloon of the utility model is prepared by the following method:

[0044] S1: Make a regular liner balloon and retain the longer tube foot;

[0045] S2: coating a layer of hydrophobic self-lubricating coating on the surface of the lining balloon, and then inflating the lining balloon to a certain pressure to put the lining balloon in an expanded state;

[0046] Specifically, the coating method is spraying or deposition; the hydrophobic self-lubricating coating is one of Teflon coating, Parylene coating, and high-density polyethylene coating.

[0047] S3: Weaving a layer of woven mesh on the surface of the liner balloon using weaving technology and equipment;

[0048] Specifically, the woven mesh is composed of axial fiber filaments and radial fiber filaments that cross each other at a certain angle, and the angle range is 0-180°; the weaving density of the fiber filaments in the woven mesh is determined according to the size of the balloon bursting pressure. The higher the bursting pressure requirement, the greater the density of the fiber filaments.

[0049] The material of the fiber filament is one or more of polypropylene, PLLA, PEEK, PI, aramid, polyester fiber, aromatic polyester (high-strength polyarylate fiber), carbon fiber, aliphatic polyamide (nylon), and ultra-high molecular weight polyethylene; the fiber filament is monofilament or multi-strand, and the fineness of the multi-strand is 10D-200D. If the fineness is too low, it is easy to cause the bursting pressure of the final woven balloon to be insufficient, and if the fineness is too high, the woven balloon will be thicker and too hard.

[0050] S4: Use light-curing or heat-curing glue or resin as the material, and evenly apply the solution to the surface of the lining balloon and the woven mesh by solution spraying or dipping;

[0051] The coating thickness is controlled by spraying or dipping parameters, and is generally controlled to be less than 0.02mm. The coated liner balloon is then placed under a UV lamp or a hot oven to cure the substrate;

[0052] S5: Deflate and remove the coated liner balloon to obtain a braided balloon.

[0053] It should be noted that in step S4, a polymer solvent can also be evenly applied to the surfaces of the lining balloon and the woven mesh by spraying or dipping, with the coating thickness controlled by spraying or dipping parameters. The coated lining balloon is then volatilized and solidified. The polymer solvent sprayed or dipped should have a lower melting point than that of the lining balloon, the woven mesh fibers, and the coating. Alternatively, a polymer film can be applied to the lining balloon and the woven mesh by winding. The polymer material is selected from the group consisting of nylon, pebax, PU, ​​and PE.

[0054] Then, the lining balloon and woven mesh coated with a coating or wrapped with a polymer film are placed in a heating device with a balloon cavity (the cavity is coated with an anti-stick coating such as Teflon or Parylene to facilitate the removal of the product as a whole after heating is completed), the lining balloon is filled with a pressure of 6-40atm, and then the device is heated to the melting point of the coated or wrapped polymer material and maintained for 5-30 minutes to melt the polymer material on the surface of the lining balloon and the woven mesh and flow evenly; the heating temperature (i.e., the melting point of the polymer material) is lower than the melting point of the lining balloon, the woven mesh fiber and the coating to prevent the lining balloon and the woven mesh from melting, and then the mold temperature is lowered to room temperature before the product is taken out as a whole.

[0055] Finally, the coated liner balloon is decompressed, deflated and withdrawn to obtain the braided balloon.

[0056] Example

[0057] The utility model provides a braided balloon, comprising an inner tube 1, a developing ring 2, a curing coating 3, a braided mesh 4, a pushing rod 5, a stress diffusion tube 6 and a catheter seat 7;

[0058] The inner tube 1 and the push rod 5 are both catheters of equal diameter, each comprising a distal end, a proximal end and a transition section;

[0059] The developing ring 2 is fixed to the inner tube 1 by bonding or forging;

[0060] The woven mesh 4 is composed of axial fiber filaments and radial fiber filaments that cross each other at a certain angle of 120°. The overall shape of the woven mesh 4 can be the same as that of an existing liner balloon in an expanded state of any shape; the woven mesh 4 includes a distal end, a proximal end and a transition section; wherein the fineness of the fiber filaments is 75D.

[0061] The cured coating 3 covers the braided mesh 4, including a distal end, a proximal end and a transition section;

[0062] The stress diffusion tube 6 is a variable diameter conduit, which is sleeved on the push rod 5 and includes a proximal end, a distal end and a gradient section;

[0063] The catheter seat 7 includes a filling cavity, a guidewire cavity, a first arc-shaped tube, a second arc-shaped tube, and a third arc-shaped tube. The filling cavity and the guidewire cavity are both variable diameter catheters, each including a proximal end, a distal end, and a gradient section; the filling cavity is obliquely arranged on the guidewire cavity, and the distal end of the filling cavity is connected to the guidewire cavity through a hole provided in the middle section of the gradient section of the guidewire cavity; the angle between the distal end of the filling cavity and the gradient section near the distal end of the guidewire cavity is 40-70°; the two ends of the first arc-shaped tube are respectively connected to the filling cavity gradient section and the guidewire cavity, the two ends of the second arc-shaped tube are respectively connected to the filling cavity gradient section and the proximal end of the guidewire cavity, and the two ends of the third arc-shaped tube are respectively connected to the proximal end and distal end of the guidewire cavity;

[0064] The distal end of the inner tube 1, the distal end of the cured coating, and the distal end of the braided mesh are welded together; the proximal end of the inner tube 1, the proximal end of the cured coating, and the proximal end of the braided mesh are welded together; the distal end of the push rod and the distal end of the braided mesh of the bonding coating machine are welded together, and the proximal end of the push rod is connected to the distal end of the guidewire cavity in the catheter seat.

[0065] The nominal diameter of the braided balloon of this embodiment is 24 mm, the bursting pressure is 32 atm, the diameter increases by 0.05 mm for every 1 atm increase in compliance pressure, and the double-layer wall thickness of the braided balloon is 0.18 mm.

[0066] Comparative Example

[0067] The balloon of this comparative example includes a liner balloon, and the remaining components are the same as those in Example 1.

[0068] The nominal diameter of the braided balloon in this comparative example is 24 mm, the bursting pressure is 32 atm, the diameter increases by 0.05 mm for every 1 atm increase in compliance pressure, and the double-layer wall thickness of the braided balloon is 0.24 mm.

[0069] It can be seen from the embodiments and comparative examples that the double-layer wall thickness of the braided balloon of the embodiment is small, and it only includes a braided layer and a cured coating, and does not include a liner balloon. Under the premise of not affecting the blasting performance and compliance, the braided balloon of the embodiment has a small thickness, so it is softer, and the flexibility of the braided balloon is improved.

[0070] The above is only a preferred specific implementation method of the present invention, but the protection scope of the present invention is not limited to this. Any changes or replacements that can be easily thought of by any technician familiar with this technical field within the technical scope disclosed in the present invention should be covered by the protection scope of the present invention.

Claims

1. A braided balloon, characterized in that: It consists of an inner tube (1), a developing ring (2), a curing coating (3), a woven mesh (4), a pushing rod (5), a stress diffusion tube (6) and a catheter seat (7); The developing ring (2) is fixed on the inner tube (1) by bonding or forging; The solidified coating (3) wraps the woven mesh (4); The stress diffusion tube (6) is sleeved on the push rod (5); The inner tube (1), the cured coating (3) and the braided mesh (4) are respectively connected at both ends; One end of the pushing rod (5) is connected to one end of the braided mesh (4), and the other end of the pushing rod (5) is connected to the catheter seat (7).

2. The braided balloon according to claim 1, characterized in that: The braided balloon does not contain a lining balloon.

3. The braided balloon according to claim 2, characterized in that: The inner tube (1) and the pushing rod (5) are both catheters of equal diameter, and each comprises a distal end, a proximal end and a transition section.

4. The braided balloon according to claim 3, characterized in that: The braided mesh (4) is composed of axial fiber filaments and radial fiber filaments intersecting each other at a certain angle, the angle ranging from 0 to 180 degrees, and the braided mesh (4) comprises a distal end, a proximal end and a transition section.

5. The braided balloon according to claim 4, characterized in that: The solidified coating (3) comprises a distal end, a proximal end and a transition section; The stress diffusion tube (6) is a variable diameter conduit, comprising a proximal end, a distal end and a gradual section.

6. The braided balloon according to claim 5, characterized in that: The catheter seat (7) comprises a filling cavity (8), a guide wire cavity (9), a first arc-shaped tube (10), a second arc-shaped tube (11), and a third arc-shaped tube (12).

7. The braided balloon according to claim 6, characterized in that: The filling cavity (8) and the guidewire cavity (9) are both variable diameter catheters, each comprising a proximal end, a distal end, and a gradient section.

8. The braided balloon according to claim 7, characterized in that: The filling cavity (8) is obliquely arranged on the guide wire cavity (9), and the distal end of the filling cavity is connected to the guide wire cavity through a hole arranged in the middle section of the guide wire cavity gradient section; The angle between the distal end of the filling cavity and the gradient section close to the distal end of the guide wire cavity is 40-70 degrees.

9. The braided balloon according to claim 8, characterized in that: The two ends of the first arc-shaped tube (10) are respectively connected to the filling cavity gradient section and the distal end of the guidewire cavity, the two ends of the second arc-shaped tube (11) are respectively connected to the filling cavity gradient section and the proximal end of the guidewire cavity, and the two ends of the third arc-shaped tube (12) are respectively connected to the proximal end and the distal end of the guidewire cavity.

10. The braided balloon according to claim 9, characterized in that: The distal end of the push rod is connected to the distal end of the braided mesh of the bonding coating machine, and the proximal end of the push rod is connected to the distal end of the guidewire cavity in the catheter seat.

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