CN117618750A - Method for assembling balloon microcatheter - Google Patents

Method for assembling balloon microcatheter Download PDF

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Publication number
CN117618750A
CN117618750A CN202311627002.9A CN202311627002A CN117618750A CN 117618750 A CN117618750 A CN 117618750A CN 202311627002 A CN202311627002 A CN 202311627002A CN 117618750 A CN117618750 A CN 117618750A
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CN
China
Prior art keywords
balloon
outer tube
pin
butyl acetate
tube
Prior art date
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Pending
Application number
CN202311627002.9A
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Chinese (zh)
Inventor
张志勇
万玲
孙宏涛
孙蓬
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Cardiolink Shenzhen Medical Technology Development Co ltd
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Cardiolink Shenzhen Medical Technology Development Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Cardiolink Shenzhen Medical Technology Development Co ltd filed Critical Cardiolink Shenzhen Medical Technology Development Co ltd
Priority to CN202311627002.9A priority Critical patent/CN117618750A/en
Publication of CN117618750A publication Critical patent/CN117618750A/en
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Abstract

An assembly method of a balloon microcatheter belongs to the field of medical appliances. The assembly method comprises the following steps: after the balloon pin is soaked in butyl acetate solution for a preset time, the connecting end of the outer tube is inserted into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon, and a mandrel is inserted into at least the connecting end of the outer tube. Through the treatment, the process of penetrating the outer tube into the balloon pin is smooth, wrinkles on the surface of the assembled balloon pin are effectively relieved or avoided, defects are effectively reduced, and assembly time is saved; the treatment mode has no pollution to the balloon, and is beneficial to reducing the bad loss of the balloon.

Description

Method for assembling balloon microcatheter
Technical Field
The application relates to the field of medical instruments, in particular to an assembly method of a balloon microcatheter.
Background
The saccule microcatheter is a core tool for B-TACE liver cancer interventional therapy. The saccule blocking causes the change of the hemodynamics of the target blood vessel, obviously reduces the pressure of the target blood vessel, realizes accurate directional tumor embolism, improves the embolism effect, protects normal tissues, improves the prognosis of patients, and can also achieve the effects of preventing embolic substances from flowing back and reducing the occurrence of ectopic embolism.
The balloon microcatheter relates to a compliant balloon, the requirement on the inner diameter of a balloon pin is high after the balloon is formed, the balloon pin and the outer tube are basically consistent in size and small in tolerance, the balloon pin and the outer tube are difficult to operate when penetrating into the outer tube due to small fit clearance, and the balloon pin is easy to crease and form bad when penetrating.
Disclosure of Invention
The application provides an assembly method of a balloon microcatheter, which can relieve the problems that the operation is difficult when a balloon pin penetrates into an outer tube, and the balloon pin is easy to crease and form bad when the balloon pin penetrates into the outer tube.
Embodiments of the present application are implemented as follows:
the application example provides an assembly method of a balloon micro-catheter, the balloon micro-catheter comprises a balloon, an inner tube and an outer tube, balloon pins are arranged at the proximal end of the balloon, the balloon pins are sleeved at the connecting end of the outer tube and fixedly connected with the outer tube, the outer tube is sleeved at the inner tube and forms a cavity between the inner tube and the outer tube, and the distal end of the balloon is connected with the inner tube.
The assembly method comprises the following steps: after the balloon pin is soaked in butyl acetate solution for a preset time, the connecting end of the outer tube is inserted into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon, and a mandrel is inserted into at least the connecting end of the outer tube.
According to the method for assembling the balloon microcatheter, the balloon pins immersed in the butyl acetate solution have lubricity and can enlarge the assembling fit clearance between the balloon pins, so that the process that the outer tube penetrates into the balloon pins is smooth, wrinkles on the surfaces of the assembled balloon pins are effectively relieved or avoided, defects are effectively reduced, and assembling time is saved; and butyl acetate volatilizes fast, and is nontoxic, and has no pollution to the sacculus, so that bad loss of the sacculus is further reduced.
In some embodiments, the mass concentration of butyl acetate in the butyl acetate solution is greater than or equal to 85%.
In some embodiments, the mass concentration of butyl acetate in the butyl acetate solution is greater than or equal to 95%.
In some embodiments, the preset time is 2-60s.
In some embodiments, the preset time is 2-30s.
In some embodiments, the balloon pin comprises at least one of silicone, polyurethane, nylon, latex, polyethylene, polyamide, polytetrafluoroethylene, and expanded polytetrafluoroethylene.
In some embodiments, the inner diameter of the balloon pin is greater than or equal to the outer diameter of the outer tube, and the difference between the inner diameter of the balloon pin and the outer diameter of the outer tube is less than or equal to 0.5mm.
In some embodiments, the connecting end of the outer tube is inserted into the balloon pin to form an overlapping portion, the overlapping portion is welded or heat fused to secure the outer tube and the balloon pin together, and the mandrel is then removed.
In some embodiments, after removal of the mandrel, the inner tube is threaded into the outer tube in a direction from the proximal end of the balloon to the distal end of the balloon to form a dual lumen structure.
In some embodiments, before the balloon pin is sleeved on the outer tube, an adhesive layer is coated on the surface of the outer tube for matching with the balloon pin, so that the balloon pin is sleeved on the outer tube and then the balloon pin and the outer tube are adhered and fixed.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered limiting the scope, and that other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic structural diagram of a balloon microcatheter provided herein;
FIG. 2 is a schematic structural view of the balloon of the present application;
fig. 3 is a schematic view of the assembled cooperation of the balloon and outer tube of the present application.
Icon: 1000-balloon microcatheter; 11-an outer tube; a 111-connection terminal; 12-an inner tube; 13-balloon; 131-balloon pins; 14-overlapping part; 15-a catheter hub; 151-a main chamber; 152-side lumen; 16-stress protection sleeve; 17-mandrel; 18-fit clearance.
Detailed Description
Embodiments of the present application will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustration of the present application and should not be construed as limiting the scope of the present application. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
As shown in fig. 1 and 2, the balloon microcatheter 1000 includes a catheter assembly, a balloon 13, a catheter hub 15, and a stress sheath 16.
The catheter assembly comprises an inner tube 12 and an outer tube 11, the outer tube 11 is coaxially sleeved on the outer Zhou Ji of the inner tube 12, and a cavity is formed between the inner tube and the outer tube, and the inner tube 12 is provided with a runner, namely, the catheter assembly formed by the inner tube 12 and the outer tube 11 is actually of a coaxial double-cavity structure.
The proximal end of the balloon 13 is one end close to the catheter seat 15, the distal end of the balloon 13 is one end far away from the catheter seat 15, the proximal end of the balloon 13 is provided with a balloon pin 131, the balloon pin 131 is sleeved on the connecting end 111 of the outer tube 11 and forms an overlapping part 14 with the connecting end 111 of the outer tube 11, and the balloon pin 131 and the connecting end 111 are fixedly connected, namely, the outer tube 11 does not extend into the balloon 13. The connection end 111 of the inner tube 12 extending out of the outer tube 11 extends to a side facing away from the balloon pins 131, the distal end of the balloon 13 being connected to the inner tube 12 and the inner tube 12 extending out of the distal end of the balloon 13.
The catheter hub 15 is provided with a main lumen 151 and a side lumen 152 independent of each other, the side lumen 152 being in communication with the lumen (the lumen formed between the inner tube 12 and the outer tube 11) for filling the balloon 13, the main lumen 151 and the inner tube 12 being in communication for compatible micro-wires and injection of drugs.
The stress protection sleeve 16 is sleeved at the joint of the catheter seat 15 and the catheter assembly.
The following is a specific description of the method of assembling the balloon microcatheter 1000 according to the embodiment of the present application:
the assembly method for the balloon microcatheter 1000 shown in fig. 1 includes:
after the balloon pins 131 are soaked in the butyl acetate solution for a preset time, the connection ends 111 of the outer tube 11 are inserted into the balloon pins 131 along the direction from the proximal end of the balloon 13 to the distal end of the balloon 13, and as shown in fig. 3, at least the connection ends 111 of the outer tube 11 are inserted with the mandrels 17.
The butyl acetate solution refers to an aqueous butyl acetate solution in this application.
The mandrel 17 is, for example, a metal tube or a metal rod, etc., and the mandrel 17 is used for supporting the outer tube 11, ensuring the surface smoothness of the outer tube 11, reducing the sleeving difficulty, and being beneficial to subsequent removal of the mandrel 17 due to the splicing arrangement, and on the other hand, the problem of bad balloon microcatheter 1000 caused by the reduction of the inner diameter of the outer tube 11 due to the deformation of the outer tube 11 can be effectively avoided in the process of welding or thermally welding the overlapped part 14 of the balloon pin 131 after sleeving the outer tube 11.
Wherein, for easy installation and removal of the mandrel 17, the outer diameter of the mandrel 17 should be slightly smaller than the inner diameter of the outer tube 11, in this application the outer diameter refers to the diameter of the outer wall and the inner diameter refers to the diameter of the inner wall.
The insertion of the mandrel 17 into at least the connecting end 111 of the outer tube 11 means that: only the connection end 111 of the outer tube 11 is inserted with the mandrel 17, or the mandrel 17 in the connection end 111 extends to the side facing away from the balloon 13 and the length of the mandrel 17 is smaller than the length of the outer tube 11, or the entire outer tube 11 is inserted with the mandrel 17.
In the application, the balloon pins 131 soaked in the butyl acetate solution have lubricity and can enlarge the fit gap 18 of the overlapped part 14 (the fit gap 18 refers to a gap between the outer wall of the connecting end 111 and the inner wall of the balloon pins 131), so that the process that the outer tube 11 penetrates into the balloon pins 131 is smooth, wrinkles generated on the surfaces of the assembled balloon pins 131 are effectively relieved or avoided, defects are effectively reduced, and the assembly time is saved; and butyl acetate volatilizes fast, and is nontoxic, and has no pollution to the sacculus 13, further reduces sacculus 13 bad loss.
In some alternative embodiments, the mass concentration of butyl acetate in the butyl acetate solution is greater than or equal to 85%.
In the above concentration range, the assembly efficiency is effectively improved, the effect of lubricating and enlarging the assembly fit gap 18 is good, the defects are effectively reduced, and the assembly time is saved.
Illustratively, the mass concentration of butyl acetate in the butyl acetate solution is any one of 85%, 87%, 90%, 93%, 95%, 98%, 100% or between any two.
In some alternative embodiments, the mass concentration of butyl acetate in the butyl acetate solution is greater than or equal to 95%.
In the above concentration range, the assembly efficiency is effectively improved, the effect of lubricating and enlarging the assembly fit gap 18 is good, the defects are effectively reduced, and the assembly time is saved.
Illustratively, the mass concentration of butyl acetate in the butyl acetate solution is any one of 95%, 96%, 97%, 98%, 99%, 100% or between any two.
In some alternative embodiments, the preset time is 2-60s.
By immersing in the butyl acetate solution for 2-60s within the mass concentration range, the lubricating property is good, the effect of enlarging the assembly fit gap 18 between the butyl acetate solution and the butyl acetate solution is good, the defects are effectively reduced, and the assembly time is saved.
Illustratively, the preset time is any one value or between any two values of 2s, 5s, 19s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s.
In some alternative embodiments, the preset time is 2-30s.
By immersing in the butyl acetate solution for 2-30s within the mass concentration range, the lubricating property is good, the effect of enlarging the assembly fit gap 18 between the butyl acetate solution and the butyl acetate solution is good, the defects are effectively reduced, and the assembly time is saved.
The preset time is, for example, any one value or between any two values of 2s, 5s, 19s, 15s, 20s, 25s, 30s.
In some alternative embodiments, the balloon pins 131 are made of at least one of silicone, polyurethane, nylon, latex, polyethylene, polyamide, polytetrafluoroethylene, and expanded polytetrafluoroethylene.
Illustratively, the balloon pins 131 are made of silica gel, polyurethane, nylon, latex, polyethylene, polyamide, polytetrafluoroethylene or expanded polytetrafluoroethylene.
In some embodiments, the balloon pins 131 are made of silicone or polyurethane.
In some alternative embodiments, the inner diameter of balloon pin 131 is greater than or equal to the outer diameter of outer tube 11, and the difference between the inner diameter of balloon pin 131 and the outer diameter of outer tube 11 is less than or equal to 0.5mm.
That is, the difference between the inner diameter of the balloon pin 131 and the outer diameter of the outer tube 11 is very small, and the sleeving difficulty is very large, and the assembly method adopted in the application can effectively reduce the sleeving difficulty between the balloon pin 131 and the outer tube, so that the product yield is improved.
In some alternative embodiments, the connection end 111 of the outer tube 11 is inserted into the balloon pin 131 to form an overlap 14, the overlap 14 is welded or heat welded to secure the outer tube 11 and the balloon pin 131 together, and the mandrel 17 is then removed.
The overlapping portion 14 is welded or thermally welded to fix the connecting end 111 of the outer tube 11 and the balloon pin 131 together, and the mandrel 17 is present at the connecting end 111 during the welding or thermal welding process, so that the problem of poor balloon microcatheter 1000 caused by reduced inner diameter of the connecting end 111 due to deformation of the outer tube 11 can be effectively avoided.
In some alternative embodiments, after removal of mandrel 17, inner tube 12 is threaded into outer tube 11 in a direction from the proximal end of balloon 13 to the distal end of balloon 13 to form a dual lumen structure.
In some alternative embodiments, before the balloon pins 131 are sleeved on the outer tube 11, an adhesive layer is coated on the surface of the outer tube 11 for matching with the balloon pins 131, so that the balloon pins 131 are sleeved on the outer tube 11 and then are adhered and fixed.
Wherein, after the balloon pin 131 is sleeved on the outer tube 11 and the balloon pin 131 and the outer tube are adhered and fixed, the assembling method further comprises removing the mandrel 17, and penetrating the inner tube 12 into the outer tube 11 along the direction from the proximal end of the balloon 13 to the distal end of the balloon 13 to form a double-cavity structure.
In either case, after the inner tube 12 is inserted into the outer tube 11 and extends beyond the distal end of the balloon 13, the distal end of the balloon 13 and the inner tube 12 may be bonded or welded, and the related art is specifically referred to and is not limited thereto.
The assembly method of the present application is described in further detail below with reference to examples.
In the following examples and comparative examples, the inner diameter of the balloon pin was 2.8mm, the wall thickness was 0.2mm, the outer diameter of the outer tube of the double lumen tube was 2.8mm, and the wall thickness was 0.2mm. The outer diameter of the inner tube is 2.0mm, and the wall thickness is 0.5mm.
Example 1
After soaking a balloon pin made of polyamide in butyl acetate solution with the mass concentration of 99% for 2s, inserting the connecting end of an outer tube into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon, and inserting a mandrel into the connecting end of the outer tube.
After the connecting end of the outer tube is inserted into the balloon pin, the overlapping parts of the outer tube and the balloon pin are connected in a welding mode, then the outer tube is cooled, the mandrel is removed, and the inner tube is penetrated into the outer tube along the direction from the proximal end of the balloon to the distal end of the balloon to form a double-cavity structure.
Example 2
It differs from example 1 only in that:
after soaking a balloon pin made of polyamide in butyl acetate solution with the mass concentration of 95% for 5s, inserting a connecting end inserted with a mandrel into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon.
Example 3
It differs from example 1 only in that:
after soaking a balloon pin made of polyamide in a butyl acetate solution with the mass concentration of 85% for 20s, inserting a connecting end inserted with a mandrel into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon.
Example 4
It differs from example 1 only in that:
after soaking a balloon pin made of polyurethane in butyl acetate solution with the mass concentration of 99% for 2s, inserting a connecting end inserted with a mandrel into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon.
Comparative example 1
It differs from example 1 only in that:
after the balloon pin made of polyamide is soaked in ethanol solution with the mass concentration of 99% for 5 seconds, the connecting end with the mandrel inserted is inserted into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon.
Comparative example 2
It differs from example 1 only in that:
the material is not soaked.
Test example 1
The maximum outer diameter of the welded balloon pins of the above examples and comparative examples was measured by a micrometer, and the results are shown in table 1.
Table 1 test results
Maximum outer profile diameter (mm) Yield (%)
Example 1 3.25 99
Example 2 3.28 97
Example 3 3.30 95
Example 4 3.26 98
Comparative example 1 3.34 81
Comparative example 2 3.48 56
As can be seen from the statistical results of table 1, the pretreatment method can effectively reduce the outer contour diameter of the welded balloon pins, improve the qualification rate of balloon catheter preparation, and the methods in comparative examples 1 and 2 often cause multiple sleeve penetration to make it difficult to insert the connecting end into the balloon pins due to the fact that the balloon pins are not pretreated or the pretreatment effect is not ideal. Violent insertion results in very pronounced and numerous folds, which are not satisfactory.
In conclusion, the assembly method of the balloon microcatheter provided by the application can effectively promote the balloon pins to penetrate into the outer tube, reduce the operation difficulty, effectively relieve or avoid the balloon pins from creasing in the penetrating process, and effectively improve the product yield.
The foregoing is merely a specific embodiment of the present application and is not intended to limit the application, and various modifications and variations may be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims (10)

1. The balloon microcatheter comprises a balloon, an inner tube and an outer tube, wherein a balloon pin is arranged at the proximal end of the balloon, the balloon pin is sleeved at the connecting end of the outer tube and is fixedly connected with the outer tube, the outer tube is sleeved at the inner tube and forms a cavity between the inner tube and the outer tube, and the distal end of the balloon is connected with the inner tube, and the method is characterized in that:
after the balloon pin is soaked in butyl acetate solution for a preset time, the connecting end of the outer tube is inserted into the balloon pin along the direction from the proximal end of the balloon to the distal end of the balloon, and a mandrel is inserted into at least the connecting end of the outer tube.
2. The assembly method according to claim 1, wherein the mass concentration of butyl acetate in the butyl acetate solution is not less than 85%.
3. The assembly method according to claim 1, wherein the mass concentration of butyl acetate in the butyl acetate solution is not less than 95%.
4. The assembly method according to claim 2, wherein the preset time is 2-60s.
5. The assembly method according to claim 2, wherein the preset time is 2-30s.
6. The method of any one of claims 1-5, wherein the balloon pins are made of at least one of silicone, polyurethane, nylon, latex, polyethylene, polyamide, polytetrafluoroethylene, and expanded polytetrafluoroethylene.
7. The assembly method according to any one of claims 1 to 5, wherein an inner diameter of the balloon pin is greater than or equal to an outer diameter of the outer tube, and a difference between the inner diameter of the balloon pin and the outer diameter of the outer tube is 0.5mm or less.
8. The method of assembly of any one of claims 1-5, wherein the connecting end of the outer tube is inserted into the balloon pin to form an overlap, the overlap is welded or heat fused to secure the outer tube and balloon pin together, and the mandrel is removed.
9. The method of assembling of claim 8, wherein after removing the mandrel, the inner tube is threaded into the outer tube in a direction from the proximal end of the balloon to the distal end of the balloon to form a dual lumen structure.
10. The method according to any one of claims 1 to 5, wherein an adhesive layer is coated on the surface of the outer tube for matching with the balloon pins before the balloon pins are sleeved on the outer tube, so that the balloon pins are fixedly adhered after being sleeved on the outer tube.
CN202311627002.9A 2023-11-29 2023-11-29 Method for assembling balloon microcatheter Pending CN117618750A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202311627002.9A CN117618750A (en) 2023-11-29 2023-11-29 Method for assembling balloon microcatheter

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202311627002.9A CN117618750A (en) 2023-11-29 2023-11-29 Method for assembling balloon microcatheter

Publications (1)

Publication Number Publication Date
CN117618750A true CN117618750A (en) 2024-03-01

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202311627002.9A Pending CN117618750A (en) 2023-11-29 2023-11-29 Method for assembling balloon microcatheter

Country Status (1)

Country Link
CN (1) CN117618750A (en)

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