CN211434683U - High-pressure balloon catheter - Google Patents
High-pressure balloon catheter Download PDFInfo
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- CN211434683U CN211434683U CN201922283987.3U CN201922283987U CN211434683U CN 211434683 U CN211434683 U CN 211434683U CN 201922283987 U CN201922283987 U CN 201922283987U CN 211434683 U CN211434683 U CN 211434683U
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Abstract
The utility model discloses a high-pressure balloon catheter, which comprises a catheter body, wherein the tail end of the catheter body is provided with a catheter seat, and an expansion balloon is sleeved on the periphery of the head part of the catheter body; the tube body comprises a main cavity channel and a side cavity channel, the side cavity channel is communicated with the expansion saccule, and the main cavity channel is communicated with the head end of the tube body; the catheter seat comprises a main cavity joint and a side cavity joint, the main cavity joint is communicated with the main cavity channel, and the side cavity joint is communicated with the side cavity channel; the expansion sacculus and the coaxial setting of body, expansion sacculus both ends fixed connection body outer wall, the expansion sacculus is including the inlayer and the skin that the complex links firmly, and inlayer elasticity is stronger than outer elasticity, is equipped with the development mark in the expansion sacculus. The utility model discloses high pressure resistant ability is strong, and product quality controls easily, and the yields is high.
Description
Technical Field
The utility model relates to the field of medical equipment, especially, relate to a high pressure sacculus pipe.
Background
In China, the number of people with cardiovascular diseases is extremely high, wherein more than 1300 ten thousand of cerebral apoplexy and more than 1100 ten thousand of coronary heart disease occur. The number of PCI operations in China in 2018 is 91.5 ten thousand. The stent penetration rate is as high as 90%, and the treatment operation of cerebrovascular stenosis is also carried out in large quantities every year. At present, the endovascular stenosis and obstruction lesions are treated mainly by endovascular balloon dilatation and stent implantation.
Balloon catheters are a tool for angioplasty. Under the guidance of medical imaging equipment, a balloon catheter is conveyed to a narrow part of a blood vessel by a percutaneous puncture technology, and the balloon is expanded under strict monitoring to expand the narrow part of the blood vessel, so that the diameter of a lumen is recovered, the blood flow is improved, and the stent is convenient to implant. After the stent is implanted successfully, the balloon is expanded to prevent restenosis.
The balloon catheter is an indispensable medical instrument for vascular interventional therapy. The high-pressure saccule is mainly used for post-expansion after stent implantation, blocking lesion of arteriovenous fistula for natural or artificial dialysis and has a certain effect on intravascular stenosis; it is also used for general calcified lesion vasodilatation. The high pressure resistance of the balloon is more than 22ATM, and the balloon is mostly a semi-compliant balloon or a non-compliant balloon.
For highly calcified vessels, a balloon with higher pressure resistance is required to ensure sufficient expansion during surgery and reduce restenosis rate after expansion. The high-pressure balloon has high hardness and extremely poor vessel permeability while meeting high-pressure performance. The existing process exists in the extrusion of a balloon material pipe as follows: deformation, eccentricity, shrinkage, bulging, surface roughness, microcracking, etc. The forming rate and the performance of the saccule in the later period are seriously influenced.
In the traditional extrusion production process, the inner diameter and the outer diameter of the material pipe are controlled by a sizing die. The method is to make the melted plastic pass through the gap of a die to be extruded and molded into a tubular shape. Due to the reasons of thermal shrinkage, gravity, eccentricity of a die, traction force, extrusion pressure and the like, the internal and external dimensions, surface white smoothness, internal defects and the like of the balloon material tube are difficult to control.
SUMMERY OF THE UTILITY MODEL
The utility model aims at providing a high pressure sacculus pipe and manufacturing method thereof, high pressure resistant ability is strong, and product quality controls easily, and the yields is high.
In order to achieve the purpose, the utility model adopts the following technical proposal to realize:
the utility model discloses a high-pressure balloon catheter, which comprises a catheter body, wherein the tail end of the catheter body is provided with a catheter seat, and an expansion balloon is sleeved on the periphery of the head part of the catheter body;
the tube body comprises a main cavity channel and a side cavity channel, the side cavity channel is communicated with the expansion saccule, and the main cavity channel is communicated with the head end of the tube body;
the catheter seat comprises a main cavity joint and a side cavity joint, the main cavity joint is communicated with the main cavity channel, and the side cavity joint is communicated with the side cavity channel;
the expansion sacculus and the coaxial setting of body, expansion sacculus both ends fixed connection body outer wall, the expansion sacculus is including the inlayer and the skin that the complex links firmly, and inlayer elasticity is stronger than outer elasticity, is equipped with the development mark in the expansion sacculus.
Preferably, the head end of the pipe body is of a conical structure.
Preferably, the developing marks are arranged on the outer wall of the pipe body, and the two developing marks are arranged along the axial direction of the pipe body.
Preferably, the diameter of the expansion balloon in the folded state is 0.8 mm-2.0 mm,
the diameter of the expansion saccule is 1.0 mm-12.0 mm under the expansion state.
Preferably, the side cavity channel is disposed in the side wall of the tube body.
Preferably, the side cavity channel is sleeved outside the main cavity channel, and the side cavity channel and the main cavity channel are coaxially arranged.
Preferably, the outer surface of the expansion balloon is provided with a drug coating.
The utility model also discloses a manufacturing method of above-mentioned high pressure sacculus pipe, including following step:
s100, co-extruding a core rod with a fixed size and an inner layer material to obtain an inner layer material pipe;
s200, rolling the extruded inner-layer material pipe, controlling the outer diameter and the surface smoothness of the inner-layer material pipe, and removing micro-defects and cracks;
s300, co-extruding an inner material pipe with a core rod and an outer material pipe to obtain a semi-finished material pipe;
s400, rolling the extruded semi-finished material pipe, controlling the outer diameter and the surface smoothness of the semi-finished material pipe, removing micro defects and cracks, and enabling an outer layer material to be tightly compounded with an inner layer material pipe to obtain a finished material pipe;
s500, extracting the core rod, and reserving a finished material pipe;
s600, blow molding a finished material pipe in a balloon mold with a specific shape to obtain an expanded balloon;
s700, assembling the obtained expansion balloon, the tube body and the catheter seat, and spraying the medicine on the surface of the balloon by using spraying equipment to obtain the high-pressure balloon catheter.
Preferably, in step S100, the balloon material is plastic or a composite thereof, including but not limited to nylon.
Preferably, in step S100, the mandrel has a fixed size, and the mandrel may be a single component metal mandrel, an alloy metal mandrel, a plastic mandrel, a composite material mandrel, or the like.
Preferably, after step S200, the inner layer pipe is cooled.
Preferably, in step S200, the rolling temperature is 0-400 ℃.
Preferably, in step S200, the rolling method is normal temperature rolling.
Preferably, in step S200, the rolling mode is high-temperature rolling.
Preferably, in step S200, the rolled roll profile may be cylindrical.
Preferably, in step S200, the rolled roll profile may be a profiled roll.
Preferably, in step S200, the rolled surface of the roll may be a profile hole rolled.
Preferably, in step S400, the temperature of the hot roll is 0 to 400 ℃.
Preferably, in step S200 and/or step S400, a plurality of rolling processes are performed, and adjacent roller pairs are arranged obliquely, i.e., non-parallel.
Preferably, in step S200 and/or step S400, the rolling process is performed a plurality of times, with adjacent roll pairs being arranged in parallel.
The utility model has the advantages that:
1. the utility model discloses when the blood vessel to high calcification pathological change, can use great pressure to strut the blood vessel, the compressive capacity is strong, has guaranteed abundant expansion, because outer setting in it, the expansion sacculus is when satisfying high pressure performance, and its blood vessel trafficability characteristic is ensured.
2. The utility model discloses using the roll technique to make the material pipe, can guaranteeing to reduce deformation, off-centre, shrink, arch, the condition such as surperficial roughness, crazing line in the production process, improved the yields, the device reliability improves the size precision of sacculus material pipe, the control of size when conveniently extruding.
Drawings
FIG. 1 is a cross-sectional view of a first embodiment of a high pressure balloon catheter;
FIG. 2 is a cross-sectional view A-A of FIG. 1;
FIG. 3 is a cross-sectional view of a second embodiment of a high pressure balloon catheter;
FIG. 4 is a cross-sectional view taken along line B-B of FIG. 2;
in the figure: 1-tube body, 2-catheter seat, 3-expansion balloon, 4-main cavity channel, 5-side cavity channel, 6-main cavity joint, 7-side cavity joint, 8-inner layer, 9-outer layer and 10-developing mark.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings.
As shown in fig. 1 and 2, an embodiment of the high-pressure balloon catheter includes a catheter body 1, a catheter seat 2 is arranged at the tail end of the catheter body 1, and an expansion balloon 3 is sleeved on the periphery of the head of the catheter body 1;
the tube body 1 comprises a main cavity channel 4 and a side cavity channel 5, the side cavity channel 5 is communicated with the expansion saccule 3, the main cavity channel 4 is communicated with the head end of the tube body 1, and the head end of the tube body 1 is of a conical structure;
the catheter seat 2 comprises a main cavity joint 6 and a side cavity joint 7, the main cavity joint 6 is communicated with the main cavity channel 4, the side cavity joint 7 is communicated with the side cavity channel 5, and the side cavity channel 5 is arranged in the side wall of the catheter body 1;
the expansion saccule 3 is coaxially arranged with the pipe body 1, the two ends of the expansion saccule 3 are fixedly connected with the outer wall of the pipe body 1, the expansion saccule 3 comprises an inner layer 8 and an outer layer 9 which are fixedly connected in a composite way, the elasticity of the inner layer 8 is stronger than that of the outer layer 9, a developing mark 10 is arranged in the expansion saccule 3, the developing mark 10 is arranged on the outer wall of the pipe body 1, the two developing marks 10 are arranged along the axial direction of the pipe body 1, the side wall of the part of the pipe body 1, which is positioned at the expansion saccule 3, is provided with an opening, the opening is communicated with a side,
the diameter of the expansion saccule 3 is 1.0 mm-12.0 mm under the expansion state,
the outer surface of the expansion saccule 3 is provided with a drug coating, such as paclitaxel, rapamycin, paclitaxel derivatives or rapamycin derivatives.
As shown in fig. 3 and 4, the second embodiment of the high-pressure balloon catheter is different from the first embodiment in that the side cavity channel 5 is sleeved outside the main cavity channel 4, and the side cavity channel 5 and the main cavity channel 4 are coaxially arranged.
The manufacturing method of the high-pressure balloon catheter comprises the following steps:
s100, co-extruding a core rod with a fixed size and an inner layer material to obtain an inner layer material pipe;
s200, rolling the extruded inner-layer material pipe, controlling the outer diameter and the surface smoothness of the inner-layer material pipe, and removing micro-defects and cracks;
s300, co-extruding an inner material pipe with a core rod and an outer material pipe to obtain a semi-finished material pipe;
s400, rolling the extruded semi-finished material pipe, controlling the outer diameter and the surface smoothness of the semi-finished material pipe, removing micro defects and cracks, and enabling an outer layer material to be tightly compounded with an inner layer material pipe to obtain a finished material pipe;
s500, extracting the core rod, and reserving a finished material pipe;
s600, blow-molding the finished material pipe in a balloon mold with a specific shape to obtain an expansion balloon 3;
s700, assembling the obtained expansion balloon 3, the tube body 1 and the catheter seat 2, and spraying the medicine on the surface of the balloon by using spraying equipment to obtain the high-pressure balloon catheter.
Of course, the present invention may have other embodiments, and those skilled in the art may make various corresponding changes and modifications according to the present invention without departing from the spirit and the essence of the present invention, and these corresponding changes and modifications should fall within the protection scope of the appended claims.
Claims (8)
1. A high pressure balloon catheter characterized by: comprises a tube body (1), a catheter seat (2) is arranged at the tail end of the tube body (1), and an expansion balloon (3) is sleeved on the periphery of the head of the tube body (1);
the tube body (1) comprises a main cavity channel (4) and a side cavity channel (5), the side cavity channel (5) is communicated with the expansion saccule (3), and the main cavity channel (4) is communicated with the head end of the tube body (1);
the catheter seat (2) comprises a main cavity joint (6) and a side cavity joint (7), the main cavity joint (6) is communicated with the main cavity channel (4), and the side cavity joint (7) is communicated with the side cavity channel (5);
the expansion sacculus (3) and the body (1) are coaxially arranged, the outer wall of the body (1) is fixedly connected with the two ends of the expansion sacculus (3), the expansion sacculus (3) comprises an inner layer (8) and an outer layer (9) which are fixedly connected in a composite mode, the elasticity of the inner layer (8) is stronger than that of the outer layer (9), and a developing mark (10) is arranged in the expansion sacculus (3).
2. The high pressure balloon catheter of claim 1, wherein: the head end of the pipe body (1) is of a conical structure.
3. The high pressure balloon catheter of claim 1, wherein: the developing marks (10) are arranged on the outer wall of the pipe body (1), and the two developing marks (10) are arranged along the axial direction of the pipe body (1).
4. The high pressure balloon catheter of claim 1, wherein:
the diameter of the expansion saccule (3) is 0.8 mm-2.0 mm under the folding state,
the diameter of the expansion saccule (3) is 1.0 mm-12.0 mm under the expansion state.
5. The high pressure balloon catheter of claim 1, wherein: the side cavity channel (5) is arranged in the side wall of the tube body (1).
6. The high pressure balloon catheter of claim 1, wherein: the side cavity channel (5) is sleeved outside the main cavity channel (4), and the side cavity channel (5) and the main cavity channel (4) are coaxially arranged.
7. The high pressure balloon catheter of claim 1, wherein: the outer surface of the expansion sacculus (3) is provided with a medicine coating.
8. The high pressure balloon catheter of claim 7, wherein: the medicine coating component is paclitaxel, rapamycin, paclitaxel derivative or rapamycin derivative.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922283987.3U CN211434683U (en) | 2019-12-18 | 2019-12-18 | High-pressure balloon catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922283987.3U CN211434683U (en) | 2019-12-18 | 2019-12-18 | High-pressure balloon catheter |
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| Publication Number | Publication Date |
|---|---|
| CN211434683U true CN211434683U (en) | 2020-09-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201922283987.3U Active CN211434683U (en) | 2019-12-18 | 2019-12-18 | High-pressure balloon catheter |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111214749A (en) * | 2019-12-18 | 2020-06-02 | 四川海汇药业有限公司 | High-pressure balloon catheter and manufacturing method thereof |
| CN114939224A (en) * | 2022-06-02 | 2022-08-26 | 上海畅德医疗科技有限公司 | High-pressure drug balloon dilatation catheter and preparation method and application thereof |
-
2019
- 2019-12-18 CN CN201922283987.3U patent/CN211434683U/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111214749A (en) * | 2019-12-18 | 2020-06-02 | 四川海汇药业有限公司 | High-pressure balloon catheter and manufacturing method thereof |
| CN111214749B (en) * | 2019-12-18 | 2024-04-23 | 四川扬子江医疗器械有限公司 | High-pressure balloon catheter and manufacturing method thereof |
| CN114939224A (en) * | 2022-06-02 | 2022-08-26 | 上海畅德医疗科技有限公司 | High-pressure drug balloon dilatation catheter and preparation method and application thereof |
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| Date | Code | Title | Description |
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| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20221108 Address after: Building 3 and 6, No. 2899, Section 4, Xihanggang Avenue, Shuangliu District, Chengdu, Sichuan 610000 Patentee after: Sichuan Yangzijiang Medical Instrument Co.,Ltd. Address before: No. 2899, section 4, xihanggang Avenue, Shuangliu District, Chengdu, Sichuan 610000 Patentee before: SICHUAN HAIHUI PHARMACEUTICAL CO.,LTD. Patentee before: SICHUAN HAIRONG PHARMACEUTICAL CO., LTD., YANGTZE RIVER PHARMACEUTICAL Group |
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| TR01 | Transfer of patent right |