A connection structure for balloon compliance testing

By designing a connection structure for balloon compliance testing, and utilizing a combination of rigid hollow tubes and elastic sealing tubes, the problems of long testing cycles and high costs in balloon catheter development were solved, enabling rapid and safe compliance testing.

CN116370802BActive Publication Date: 2026-02-27JIANGSU BIODA LIFE SCI CO LTD
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Patent Information

Application Number
CN202211734619.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-12-31
Publication Date
2026-02-27
Estimated Expiration
2042-12-31

AI Technical Summary

Technical Problem

The compliance testing of existing balloon catheters during the research and development stage requires welding and assembly, resulting in long development cycles, high costs, and great difficulty, making it impossible to quickly complete the compliance testing of the balloon body.

Method used

A connection structure for balloon compliance testing was designed, including a balloon body, a Luer connector, a connecting tube, and a fixing connector. By combining a rigid hollow tube and an elastic sealing tube, the balloon body is directly connected to the compliance testing equipment, ensuring sealing and stability.

Benefits of technology

It enables rapid connection between the balloon body and the compliance testing equipment, reducing the R&D cycle, cost and difficulty, and ensuring the safety and effectiveness of the test.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a connecting structure for balloon body compliance test, which comprises a balloon body, a luer joint, a connecting pipe and a fixed connecting piece connected to the two ends of the luer joint respectively, wherein the balloon body comprises a left straight section, a right straight section and an intermediate filling section; the left straight section passes through the fixed connecting piece and the luer joint in sequence and is sleeved in the connecting pipe; a rigid hollow pipe is sleeved in the left straight section; one end of the rigid hollow pipe near the left straight section extends to the inside of the connecting pipe; and the right straight section is provided with a pipeline blocking device. The application can guarantee the sealing of the connecting end of the balloon body while ensuring the input pressure of the balloon body, so that the balloon body can be directly connected with the compliance test equipment, the compliance test of the balloon body can be quickly completed, and the research and development cycle, cost and difficulty of the new balloon catheter product are reduced.
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Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical device testing apparatus, in particular to a connecting structure for balloon body compliance testing. BACKGROUND

[0002] Balloon catheter dilatation is mainly used to dilate the stenosis or occlusion of the lesion blood vessels, and improve the blood oxygen supply of the surrounding tissues and organs. The basic method of balloon catheter dilatation is to transport the balloon body to the lesion blood vessel site through the balloon catheter, and to dilate the balloon body by filling a certain pressure liquid into the balloon catheter through the catheter connection port. When the balloon body is filled to a certain diameter, the force exerted by the balloon body on the blood vessel can dilate the stenosis or occlusion of the blood vessel site, and then restore the blood flow in the target blood vessel.

[0003] Balloon body compliance testing refers to measuring the corresponding diameter of the balloon body under different pressures. Within the safe range of the input value of the pressure liquid pressure, the diameter of the balloon body will increase according to a certain proportion as the pressure of the pressure liquid increases. In clinical use, the corresponding liquid pressure input value of the balloon body will be set according to the specific conditions of the patient's blood vessel lesion site, so that the balloon body is filled to the target diameter. If the set pressure value is too large, the diameter of the balloon body after filling may exceed the safe size in clinical use, causing irreversible damage to the blood vessel wall, which is related to the safety of the human body. If the set pressure value is too small, the diameter of the balloon body after filling cannot fully dilate the stenosis or occlusion of the blood vessel, and cannot restore the normal blood supply, which is related to the effectiveness of balloon dilatation. In order to ensure the safety and effectiveness of the balloon body site during the blood vessel dilatation process, it is necessary to test the compliance of the balloon body.

[0004] The connecting device of the current balloon compliance testing equipment can only connect the Y-shaped joint interface of the balloon catheter product. In the research and development stage of the balloon body, the balloon body and the catheter, the Y-shaped joint and other components need to be welded and assembled to form a balloon catheter product, so that the compliance of the balloon body can be tested. For a newly developed balloon catheter product, the welding and assembly process also needs a certain period of research and development and verification. During the early stage of the entire project, testing the compliance of the balloon body through the balloon catheter product will increase the research and development cycle, research and development cost and research and development difficulty of the entire project.

[0005] Therefore, how to directly connect the balloon body with the compliance testing equipment, quickly complete the compliance testing of the balloon body, and reduce the research and development cycle, research and development cost and research and development difficulty of the development of new balloon catheter products has become the research direction of the technical personnel in the field. SUMMARY

[0006] The present application aims to overcome the deficiencies of the prior art, and provide a connection structure for balloon body compliance testing, so as to solve the technical problems presented in the background.

[0007] The purpose of the present application is achieved by the following technical solutions:

[0008] The present application provides a connection structure for balloon body compliance testing, which comprises a balloon body, a luer joint, a connecting pipe and a fixed connecting piece connected to the two ends of the luer joint respectively, wherein the balloon body comprises a left straight section, a right straight section and an intermediate filling section arranged between the left straight section and the right straight section, the left straight section passes through the fixed connecting piece and the luer joint in sequence and is sleeved in the connecting pipe, a rigid hollow pipe is further sleeved in the left straight section, one end of the rigid hollow pipe near the left straight section extends to the inside of the connecting pipe, and a pipeline blocking device is connected to the right straight section.

[0009] The fixed connecting piece comprises an upper end connecting section and a lower end fixed section, the upper end connecting section is connected to the luer joint, an accommodating cavity is arranged on the upper end connecting section, an elastic sealing pipe and a pressing block sleeved on the left straight section of the balloon body are arranged in the accommodating cavity, and the lower end fixed section is fixed to the upper end connecting section and fixes the elastic sealing pipe and the pressing block in the accommodating cavity.

[0010] In the above invention, further, a connecting head and a threaded section are arranged on the upper end connecting section, the upper end connecting section is connected to the luer joint through the connecting head, an external thread is arranged on the threaded section, an internal thread is arranged on the lower end fixed section, and the lower end fixed section is fixed to the threaded section of the upper end connecting section through threaded connection.

[0011] In the above invention, further, a fixing groove is arranged in the lower end fixed section, the pressing block is arranged in the fixing groove, and the lower end fixed section fixes the pressing block and the elastic sealing pipe in the accommodating cavity through the fixing groove.

[0012] In the above invention, further, an end of the connecting pipe is further provided with an interface for connecting a compliance testing device.

[0013] In the above invention, further, anti-slip patterns are arranged on the upper end connecting section and the lower end fixed section.

[0014] In the above invention, further, the rigid hollow pipe is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy material, the length of the rigid hollow pipe is 30-60 mm, the outer diameter is 0.5-1.8 mm, and the inner diameter is 0.3-1.4 mm.

[0015] In the above summary, further, the fixed connecting piece is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy, nickel-titanium alloy, polycarbonate, polyether ether ketone or ABS resin, and the length of the fixed connecting piece is 10-30mm.

[0016] In the above summary, further, the elastic sealing tube is made of rubber, silicone or polyurethane, and the length of the elastic sealing tube is 3-10mm, the inner diameter is 1.6-2.5mm, and the wall thickness is 0.5-2mm.

[0017] In the above summary, further, the connecting tube is made of polyvinyl chloride, polyether ether ketone, polytetrafluoroethylene or polyethylene, and the length of the connecting tube is 30-50cm.

[0018] In the above summary, further, the left flat section of the balloon body extends into the connecting tube by 20-40mm.

[0019] The present application has the following beneficial effects:

[0020] The present application can ensure the sealing of the balloon body connecting end while ensuring the input pressure of the balloon body, so that the balloon body can be directly connected with the compliance testing equipment, the compliance test of the balloon body is quickly completed, and the research and development cycle, cost and difficulty of the new balloon catheter product are reduced. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 The figure is a structural schematic diagram of the present application;

[0022] Figure 2 The figure is another structural schematic diagram of the present application;

[0023] Figure 3 The figure is a structural schematic diagram of the fixed connecting piece of the present application;

[0024] Figure 4 The figure is a connection structure schematic diagram between the fixed connecting piece, the elastic sealing tube and the pressing block of the present application.

[0025] In the figure, 1 is a connecting tube, 2 is a rigid hollow tube, 3 is an elastic sealing tube, 4 is a fixed connecting piece, 4.1 is an upper end connecting section, 4.11 is a containing cavity, 4.12 is a connecting head, 4.13 is a threaded section, 4.14 is an external thread, 4.2 is a fixed section, 4.21 is a fixed groove, 4.22 is an internal thread, 5 is a balloon body, 5.1 is a left flat section of the balloon body, 5.2 is a middle filling section of the balloon body, 5.3 is a right flat section of the balloon body, 6 is a luer joint, 7 is a pipeline plugging device, 8 is a pressing block, and 9 is an interface. DETAILED DESCRIPTION

[0026] Following, the embodiments of the present application are illustrated by specific examples, and other advantages and effects of the present application can be easily understood by those skilled in the art from the disclosure of the present specification. The present application can also be implemented or applied by other different embodiments, and various modifications or changes can be made to the details in the present specification based on different views and applications without departing from the spirit of the present application. It should be noted that the following examples and features in the examples can be combined with each other without conflict.

[0027] It should be noted that the diagrams provided in the following examples only illustrate the basic concept of the present application in a schematic manner, and only the components related to the present application are shown in the diagrams, not the number, shape and size of the components when actually implemented. The actual implementation of each component may be a random change in type, number and proportion, and the component layout pattern may also be more complex.

[0028] Embodiment:

[0029] A connection structure for balloon body compliance test, please refer to the attached Figure 1 -attached Figure 4 As shown, including balloon body 5, luer joint 6 and connecting pipe 1 and fixed connecting piece 4 connected at both ends of the luer joint 6 respectively, the end of the connecting pipe 1 is provided with an interface 9 for connecting the compliance test equipment, the balloon body 5 includes a balloon left flat section 5.1, a balloon right flat section 5.3 and a balloon middle filling section 5.2 arranged between the balloon left flat section 5.1 and the balloon right flat section 5.3, the balloon left flat section 5.1 passes through the fixed connecting piece 4 and the luer joint 6 in turn and is sleeved in the connecting pipe 1, and the balloon left flat section 5.1 extends into the connecting pipe 1 by 20-40 mm, a rigid hollow pipe 2 is also sleeved in the balloon left flat section 5.1, one end of the rigid hollow pipe 2 near the end of the balloon left flat section 5.1 extends into the connecting pipe 1, the rigid hollow pipe 2 is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy material, which strengthens the connection strength between the connecting pipe 1 and the balloon left flat section 5.1, so that the connection between the connecting pipe 1 and the balloon left flat section 5.1 is not easy to bend and deform during use, the length of the rigid hollow pipe 2 is 30-60 mm, the outer diameter is 0.5-1.8 mm, and the inner diameter is 0.3-1.4 mm, the balloon right flat section 5.3 is connected with a pipeline plugging device 7.

[0030] The fixed connecting piece 4 comprises an upper end connecting section 4.1 and a lower end fixed section 4.2, the upper end connecting section 4.1 is connected to the luer joint 6, and an accommodation cavity 4.11 is arranged on the upper end connecting section 4.1, an elastic sealing tube 3 and a pressing block 8 are arranged in the accommodation cavity 4.11 and are sleeved on the left flat section 5.1 of the balloon body, the lower end fixed section 4.2 is fixed on the upper end connecting section 4.1 and fixes the elastic sealing tube 3 and the pressing block 8 in the accommodation cavity 4.11, more specifically, a connecting head 4.12 and a threaded section 4.13 are arranged on the upper end connecting section 4.1, the upper end connecting section 4.1 is connected to the luer joint 6 through the connecting head 4.12, and an external thread 4.14 is arranged on the threaded section 4.13, an internal thread 4.22 is arranged on the lower end fixed section 4.2, and the lower end fixed section 4.2 is fixed on the threaded section 4.13 of the upper end connecting section 4.1 in a threaded connection mode, preferably, anti-skid lines are arranged on the upper end connecting section 4.1 and the lower end fixed section 4.2, so that the lower end fixed section 4.2 can be screwed on the upper end connecting section 4.1.

[0031] In the use process of the present application, the connecting pipe 1 is connected to the compliance testing device through the interface 9, and the pipeline plugging device 7 is used to plug the right flat section 5.3 of the balloon body, the compliance testing device is started, the test liquid with pressure enters the connecting pipe 1 and flows into the middle filling section 5.2 of the balloon body through the rigid hollow pipe 2 to test the balloon body in the middle filling section 5.2, in the present application, since the elastic sealing tube 3 is fixed in the accommodation cavity 4.11 through the pressing block 8, when the lower end fixed section 4.2 is screwed on the upper end connecting section 4.1, the pressing block 8 extrudes the elastic sealing tube 3, the elastic sealing tube 3 is deformed, the left flat section 5.1 of the balloon body is fixed on the fixed connecting piece 4, and the balloon body 5 is prevented from falling off during the test, at the same time, the elastic sealing tube 3, the left flat section 5.1 of the balloon body and the rigid hollow pipe 2 form a three-layer sandwich structure and are tightly fitted together to form a sealed structure, so that liquid leakage is prevented during the test, as a more preferred embodiment, please refer to the accompanying drawings Figure 3 and the accompanying drawings. Figure 4 As shown in the drawings, the lower end fixed section 4.2 is provided with a fixed groove 4.21, the pressing block 8 is arranged in the fixed groove 4.21, and the lower end fixed section 4.2 fixes the pressing block 8 and the elastic sealing tube 3 in the accommodation cavity 4.11 through the fixed groove 4.21, and the fixed groove 4.21 arranged on the lower end fixed section 4.2 can better fix the pressing block 8 and the elastic sealing tube 3 in the accommodation cavity 4.11, and the connection and sealing effect are enhanced.

[0032] In the above embodiment, as a preferred embodiment, the fixed connecting piece 4 is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy, nickel-titanium alloy, polycarbonate, polyether ether ketone or ABS resin, and the length of the fixed connecting piece is 10-30 mm.

[0033] In the above embodiment, as a preferred embodiment, the elastic sealing tube 3 is made of rubber, silicone or polyurethane, the length of the elastic sealing tube is 3-10 mm, the inner diameter is 1.6-2.5 mm, and the wall thickness is 0.5-2 mm.

[0034] In the above embodiment, as a preferred embodiment, the connecting tube 1 is made of polyvinyl chloride, polyether ether ketone, polytetrafluoroethylene or polyethylene, and the length of the connecting tube is 30-50 cm.

[0035] The above embodiments only express the specific embodiments of the present application, which are described in detail and specifically, but cannot be understood as the limitation of the patent scope of the present application. It should be noted that, for those skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are all within the protection scope of the present application.

Claims

1. A connection structure for a balloon compliance test, characterized by, The balloon catheter comprises a balloon body (5), a luer joint (6), a connecting tube (1) and a fixed connecting piece (4) connected to the two ends of the luer joint (6) respectively. The balloon body (5) comprises a left straight section (5.1), a right straight section (5.3) and an intermediate filling section (5.2) arranged between the left straight section (5.1) and the right straight section (5.3). The left straight section (5.1) passes through the fixed connecting piece (4) and the luer joint (6) in sequence and is sleeved in the connecting tube (1). A rigid hollow tube (2) is sleeved in the left straight section (5.1). One end of the rigid hollow tube (2) near the left straight section (5.1) extends to the inside of the connecting tube (1). The right straight section (5.3) is connected with a pipeline blocking device (7). The fixed connecting piece (4) comprises an upper end connecting section (4.1) and a lower end fixed section (4.2). The upper end connecting section (4.1) is connected to the luer joint (6). An accommodation cavity (4.11) is arranged on the upper end connecting section (4.1). An elastic sealing tube (3) and a pressing block (8) are arranged in the accommodation cavity (4.11) and sleeved on the left straight section (5.1). The lower end fixed section (4.2) is fixed on the upper end connecting section (4.1) and fixes the elastic sealing tube (3) and the pressing block (8) in the accommodation cavity (4.11). When the lower end fixed section (4.2) is screwed on the upper end connecting section (4.1), the pressing block (8) extrudes the elastic sealing tube (3), so that the elastic sealing tube (3) deforms, thereby fixing the left straight section (5.1) on the fixed connecting piece (4). The elastic sealing tube (3), the left straight section (5.1) and the rigid hollow tube (2) form a three-layer sandwich structure. A connecting head (4.12) and a threaded section (4.13) are arranged on the upper end connecting section (4.1). The upper end connecting section (4.1) is connected to the luer joint (6) through the connecting head (4.12). An external thread (4.14) is arranged on the threaded section (4.13). An internal thread (4.22) is arranged on the lower end fixed section (4.2). The lower end fixed section (4.2) is fixed on the threaded section (4.13) of the upper end connecting section (4.1) through threaded connection. A fixed groove (4.21) is arranged in the lower end fixed section (4.2). The pressing block (8) is arranged in the fixed groove (4.21). The lower end fixed section (4.2) fixes the pressing block (8) and the elastic sealing tube (3) in the accommodation cavity (4.11) through the fixed groove (4.21).

2. The connection structure for balloon compliance test according to claim 1, wherein An interface (9) for connecting a compliance testing device is arranged on the end of the connecting tube (1).

3. The connection structure for balloon compliance test according to claim 2, wherein Anti-slip patterns are arranged on the upper end connecting section (4.1) and the lower end fixed section (4.2).

4. The connection structure for balloon compliance test according to any one of claims 1 to 3, wherein The rigid hollow tube (2) is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy or nickel-titanium alloy material, the length of the rigid hollow tube is 30-60 mm, the outer diameter is 0.5-1.8 mm, and the inner diameter is 0.3-1.4 mm.

5. The connection structure for balloon compliance test according to any one of claims 1 to 3, wherein The fixed connecting piece (4) is made of 304 stainless steel, 316L stainless steel, cobalt-chromium alloy, nickel-titanium alloy, polycarbonate, polyether ether ketone or ABS resin, and the length of the fixed connecting piece is 10-30 mm.

6. The connection structure for balloon compliance test according to any one of claims 1 to 3, wherein The elastic sealing tube (3) is made of rubber, silicone or polyurethane, the length of the elastic sealing tube is 3-10 mm, the inner diameter is 1.6-2.5 mm, and the wall thickness is 0.5-2 mm.

7. The connection structure for balloon compliance test according to any one of claims 1 to 3, wherein The connecting tube (1) is made of polyvinyl chloride, polyether ether ketone, polytetrafluoroethylene or polyethylene, and the length of the connecting tube (1) is 30-50 cm.

8. The connection structure for balloon compliance test according to any one of claims 1 to 3, wherein The left flat section (5.1) of the capsule extends into the connecting tube (1) by 20-40 mm.

Citation Information

Patent Citations

  • Pressure pipeline connecting structure

    CN109973727A

  • Connecting structure for balloon body compliance test

    CN219127936U

  • Balloon catheter with improved pressure source

    US6190354B1