Balloon catheter biocompatibility testing device

By designing a balloon catheter biocompatibility test device, using simulated regulatory mechanisms and independent detection mechanisms, the safety and data acquisition problems of balloon catheter biocompatibility test are solved, and safe and efficient biocompatibility tests and rapid acquisition of results are achieved.

CN120254194BActive Publication Date: 2025-08-19JIANGSU KEBIAO MEDICAL TECH GRP CO LTD
View PDF 2 Cites 0 Cited by

Patent Information

Application Number
CN202510728172.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-06-03
Publication Date
2025-08-19
Estimated Expiration
2045-06-03

AI Technical Summary

Technical Problem

In the prior art, the biocompatibility test of balloon catheters has problems such as high risk coefficient, high difficulty and inconvenient data acquisition.

Method used

A balloon catheter biocompatibility testing device is designed, including a closed protection mechanism, an independent detection mechanism and a simulation regulation mechanism. The biological sample is clamped through the simulation regulation mechanism, and three independent simulation chambers are set up outside the biological sample. Different detection media are used to selectively inject them into the chamber. The balloon catheter extends into the sample for compatibility testing. The test results are quickly conveyed through the simulation chamber for easy data collection.

Benefits of technology

It realizes the safety of biocompatibility testing and the convenience of data collection, can simulate the tissue status in the organism, conduct multiple types of comparison tests, and quickly obtain test results.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN120254194B_ABST
    Figure CN120254194B_ABST
Patent Text Reader

Abstract

The present invention relates to the field of balloon catheter testing technology, specifically a balloon catheter biocompatibility testing device, comprising a sealed protective mechanism, three groups of independent detection mechanisms arranged in the sealed protective mechanism, and a simulation control mechanism arranged in the sealed protective mechanism and located between the three groups of independent detection mechanisms. By setting up a sealed protective mechanism and a simulation control mechanism inside the sealed protective mechanism, the simulation control mechanism is used to clamp the biological sample, and the simulation control mechanism is combined with the biological sample to perform gradual tightening, and three independent simulation chambers are set outside the biological sample. After different detection media are selectively injected into the three simulation chambers, the balloon catheter is extended into the biological sample and the compatibility of the three pre-treated parts after expansion is targetedly tested, and the test results can be quickly transmitted to the outside through the three simulation chambers, thereby facilitating data collection.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] The invention relates to the technical field of balloon catheter testing, in particular to a balloon catheter biocompatibility testing device. Background Art

[0002] Balloon catheters are used to facilitate the insertion of intravascular catheters and guide them into the target carotid artery. They provide temporary vascular occlusion during angiography or other procedures. They can also serve as a channel for retrieval devices.

[0003] After production, balloon catheters need to undergo fatigue testing, high-voltage testing, diameter and filling pressure testing. These tests only test the performance of the device itself. Since the balloon catheter needs to be inserted into the patient's body, the balloon catheter entering the patient's body needs to undergo biocompatibility testing. However, direct biological testing is more risky and difficult, and the test data is not easy to collect.

[0004] In view of this, a balloon catheter biocompatibility testing device is designed to solve the above problems. Summary of the Invention

[0005] The present invention aims to solve one of the technical problems existing in the prior art or related technologies.

[0006] To this end, the technical solution adopted in the present invention is:

[0007] A balloon catheter biocompatibility testing device includes a sealed protective mechanism, three independent detection mechanisms arranged in the sealed protective mechanism, a simulation control mechanism arranged in the sealed protective mechanism and located between the three independent detection mechanisms, a biological sample arranged in the simulation control mechanism and clamped, a sample lining mechanism and a balloon catheter that penetrates into the interior of the biological sample, and the balloon catheter is located in the middle of the biological sample cavity; the sealed protective mechanism includes an outer cover and three protective frames arranged in the outer cover; the independent detection mechanism includes a first built-in cabin arranged in a cavity at one end of the protective frame, a second built-in cabin arranged in a cavity at the other end of the protective frame, and the first built-in cabin and the second built-in cabin are arranged in a cavity at one end of the protective frame. Both ends are equipped with booster plates for providing simulated chambers for the outside of the biological sample segments; the simulated control mechanism includes a slide rail, two sample end locking outer parts arranged inside the slide rail, and two sample end locking inner parts arranged on the sample end locking outer parts, and the number of the sample end locking inner parts is four; the two sample end locking outer parts and the four sample end locking inner parts are used to lock the two ends of the biological sample and adjust the tightness of the biological sample after it is placed horizontally; the sample lining mechanism includes six reinforcing gaskets, and two reinforcing gaskets constitute a group, which are used to provide support for the inner wall segments of the biological sample; after the balloon catheter is expanded, it is used to perform compatibility testing on the three segments of the biological sample after separation.

[0008] In a preferred embodiment of the present invention, the independent detection mechanism may be further configured as follows: the independent detection mechanism further includes six bases and a drain pipe installed in the hole at the bottom of the first built-in cabin, wherein a ball valve is provided inside the drain pipe and a hose is provided at the outer end of the drain pipe;

[0009] A detection tube and a liquid inlet tube are provided on the top of the first built-in cabin and the second built-in cabin, and the liquid inlet tube is used to guide the input of different detection media, and the detection tube is used to provide an effective path for the detection equipment;

[0010] The number of the first built-in compartment and the number of the second built-in compartment are both three;

[0011] Three of the bases are installed on the outside of the three first built-in compartments, and the other three bases are installed on the outside of the three second built-in compartments.

[0012] In a preferred embodiment of the present invention, the analog control mechanism may be further configured as follows: the analog control mechanism further includes two cover plates provided at both ends of the slide rail, two second screw rods movably mounted inside the two cover plates, and two sample end locking outer members are respectively provided on the threaded sections of the two second screw rods, a compression bolt provided inside the sample end locking outer member, a slider movably mounted inside the two sample end locking inner members, a clamping seat fixedly mounted on the outer wall of the sample end locking inner member, a force arm movably mounted on the clamping seat, a third screw rod movably mounted inside the slider, and;

[0013] The other end of the lever arm is movably mounted on the cushion.

[0014] In a preferred embodiment, the present invention can be further configured as follows: the sealed protective mechanism further includes a bracket mounted on one end of the outer cover, two clamps fixedly mounted on the top of the protective frame, a first screw rod movably mounted inside the clamps, a second clamp mounted on the top of the protective frame, and a first clamp mounted on the protective frame;

[0015] Two symmetrically distributed sliding grooves are provided at the bottom of the inner cavity of the outer cover.

[0016] In a preferred embodiment, the present invention can be further configured as follows: the analog control mechanism further includes a main baffle, a pipe sleeve disposed in the main baffle, a main line sleeve installed in the main baffle, a fixing bolt disposed in the main line sleeve, and a secondary line sleeve installed in the secondary baffle;

[0017] The interior of the tube sleeve is provided with a through hole for guiding the balloon catheter to extend therein.

[0018] In a preferred example, the present invention can be further configured as follows: the sample lining mechanism also includes a traction line movably installed inside the six reinforcing gaskets and six gaskets fixedly installed on the traction line.

[0019] In a preferred embodiment, the present invention can be further configured as follows: the main line sleeve and the auxiliary line sleeve are both provided with a transverse hole constrained by the traction line;

[0020] The traction line passes through one end of the secondary line sleeve and is provided with an anti-slip column head.

[0021] In a preferred example, the present invention can be further configured as follows: the bracket is composed of a T-shaped leg and a stud, and the stud is adapted to pass through the outside of the auxiliary baffle, and the nut provided on the stud is used to fix the auxiliary baffle.

[0022] In a preferred example, the present invention can be further configured as follows: a semicircular rubber pad is provided in the arc-shaped notch on the inner side of the pressurizing plate, and the semicircular rubber pad is used to press the outer wall of the biological sample.

[0023] In a preferred example, the present invention can be further configured as follows: the analog control mechanism further includes two bottom plates, and the two bottom plates are fixedly installed on the inner side of the main baffle.

[0024] By adopting the above technical solution, the beneficial effects achieved by the present invention are as follows:

[0025] 1. The present invention provides a sealed protective mechanism, and a simulation control mechanism is provided inside the sealed protective mechanism. The simulation control mechanism is used to clamp the biological sample, and the biological sample is gradually tightened in combination with the simulation control mechanism. Three independent simulation chambers are provided outside the biological sample. After different detection media are selectively injected into the three simulation chambers, the balloon catheter is extended into the biological sample and the compatibility of the three pre-treated parts after expansion is targeted. The test results can be quickly transmitted to the outside through the three simulation chambers, thereby facilitating data collection.

[0026] 2. The present invention selectively adjusts the tension of a horizontally placed biological sample by adjusting a simulation control mechanism. At this time, the three locations of the biological sample, clamped by multiple reinforcing gaskets, three sets of first built-in chambers, and a second built-in chamber, can simulate the real-time state of tissue in a living organism. After being immersed in different detection media, the three locations of the biological sample in different loosening states can be used for multiple types of comparative testing.

[0027] 3. The present invention controls the distribution of multiple reinforcing gaskets inside the biological sample through a traction line and multiple gaskets outside the traction line. When the length of the biological sample detection needs to be changed, two of the reinforcing gaskets can be introduced into a group of independent detection mechanisms near the outer end of the outer cover. As the balloon catheter is inflated, the traction line will not interfere with the expansion of the balloon, nor will it hinder the real-time compression of the biological sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 This is a schematic diagram of the present invention when in use;

[0029] Figure 2 It is a three-dimensional schematic diagram of the present invention;

[0030] Figure 3 It is an explosion diagram of the present invention;

[0031] Figure 4 is a schematic diagram of the sealed protection mechanism of the present invention;

[0032] Figure 5 For the present invention Figure 2 A partial explosion diagram;

[0033] Figure 6 This is a schematic diagram of the explosion simulation control mechanism of the present invention;

[0034] Figure 7 For the present invention Figure 6 Schematic diagram of a partial explosion;

[0035] Figure 8 For the present invention Figure 7 A magnified schematic diagram of point A in the middle;

[0036] Figure 9 Schematic diagram of the explosion of the independent detection mechanism of the present invention;

[0037] Figure 10 For the present invention Figure 9 A magnified schematic diagram of point B in the middle;

[0038] Figure 11 For the present invention Figure 9 Schematic diagram of a local explosion.

[0039] Reference numerals:

[0040] 100, sealed protection mechanism; 110, outer cover; 120, slideway; 130, bracket; 140, protective frame; 150, chuck; 160, first screw rod; 170, first jacket; 180, second jacket;

[0041] 200, independent detection mechanism; 210, first internal compartment; 220, second internal compartment; 230, drain pipe; 240, pressurization plate; 250, base; 260, detection tube; 270, liquid inlet pipe;

[0042] 300, analog control mechanism; 310, main baffle; 3101, pipe sleeve; 3102, main line sleeve; 3103, fixing bolt; 3104, bottom plate; 320, auxiliary baffle; 3201, auxiliary line sleeve; 330, slide rail; 340, cover plate; 350, second screw; 360, sample end locking outer member; 3601, pressing bolt; 3602, sample end locking inner member; 3603, clamping seat; 3604, slider; 3605, lever arm; 3606, gasket; 3607, third screw;

[0043] 400. Biological samples;

[0044] 500, sample lining mechanism; 510, traction line; 520, gasket; 530, reinforcement ring;

[0045] 600. Balloon catheter. DETAILED DESCRIPTION

[0046] To make the purpose, technical solutions and advantages of the present invention more clear, the present invention is further described in detail below in conjunction with specific embodiments and with reference to the accompanying drawings. It should be noted that the embodiments of the present invention and the features therein can be combined with each other without conflict.

[0047] It should be understood that these descriptions are exemplary only and are not intended to limit the scope of the invention.

[0048] A balloon catheter biocompatibility testing device provided by some embodiments of the present invention will be described below with reference to the accompanying drawings.

[0049] Example 1:

[0050] Combine Figures 1 to 11As shown, the present invention provides a balloon catheter biocompatibility testing device, comprising a sealed protection mechanism 100, three sets of independent detection mechanisms 200 arranged in the sealed protection mechanism 100, a simulation control mechanism 300 arranged in the sealed protection mechanism 100 and located between the three sets of independent detection mechanisms 200, a biological sample 400 arranged in the simulation control mechanism 300 and clamped, a sample lining mechanism 500 penetrating into the interior of the biological sample 400, and a balloon catheter 600, wherein the balloon catheter 600 is located in the middle of the inner cavity of the biological sample 400, and the sealed protection mechanism 100 is used to test the three sets of independent detection mechanisms 200. The independent detection mechanism 200 provides a sufficiently stable support platform and provides airtight protection for the simulation control mechanism 300. The three groups of independent detection mechanisms 200 are used to clamp the three selected sections of the biological sample 400 and provide a simulation chamber for the three clamped sections. The simulation control mechanism 300 is used to adjust the tightness of the biological sample 400 and simulate the changes in biological tissue. The sample lining mechanism 500 is used to cooperate with the three groups of independent detection mechanisms 200 to provide support for the inner wall of the biological sample 400. The balloon catheter 600 is used to detect the three selected sections of the biological sample 400 and perform biocompatibility testing.

[0051] The sealed protection mechanism 100 includes an outer cover 110 and three protection frames 140 disposed within the outer cover 110;

[0052] The independent detection mechanism 200 includes six bases 250, a first internal chamber 210 disposed within a cavity at one end of the protective frame 140, and a second internal chamber 220 disposed within a cavity at the other end of the protective frame 140. A pressurization plate 240 is mounted at each end of the first and second internal chambers 210, 220. A semicircular rubber pad is disposed within the arc-shaped notch on the inner side of the pressurization plate 240, and the semicircular rubber pad is used to compress the outer wall of the biological sample 400.

[0053] The analog control mechanism 300 includes a main baffle 310 and a slide rail 330, two sample end locking outer members 360 disposed within the slide rail 330, two sample end locking inner members 3602 disposed on the sample end locking outer members 360, and four sample end locking inner members 3602; a pipe sleeve 3101 disposed within the main baffle 310; a main line sleeve 3102 mounted within the main baffle 310; a fixing bolt 3103 disposed within the main line sleeve 3102; and a secondary line sleeve 3201 mounted within the secondary baffle 320.

[0054] The two sample end locking outer pieces 360 and the four sample end locking inner pieces 3602 are used to lock the two ends of the biological sample 400 and adjust the tightness of the biological sample 400 after it is placed horizontally;

[0055] The sample lining mechanism 500 includes six reinforcing rings 530 , a traction line 510 movably mounted inside the six reinforcing rings 530 , and six gaskets 520 fixedly mounted on the traction line 510 . Two reinforcing rings 530 form a group, and are used to provide segmented support for the inner wall of the biological sample 400 .

[0056] The interior of the tube sleeve 3101 is provided with a through hole for guiding the balloon catheter 600 to extend therein;

[0057] The main line sleeve 3102 and the auxiliary line sleeve 3201 are both provided with a transverse hole constrained by the traction line 510;

[0058] One end of the traction line 510 that passes through the secondary line sleeve 3201 is provided with an anti-slip stud.

[0059] Loosen the two tightening bolts 3601 and control the two third screws 3607 to reverse. Then, insert the two ends of the biological sample 400 into the inner sides of the two sample end locking outer parts 360 respectively, and use the four sample end locking inner parts 3602 to fix the two ends of the biological sample 400 in the two sample end locking outer parts 360.

[0060] In the first stage, the two second screw rods 350 are controlled to rotate forward until the two sample end locking outer pieces 360 extend outward along the threaded sections of the two second screw rods 350. Finally, the two sample end locking outer pieces 360 cooperate with the four sample end locking inner pieces 3602 to tighten the horizontally placed biological sample 400. The biological sample 400 in the tightened state needs to be delivered to the interior of the outer cover 110. Then, the six first screw rods 160 are adjusted in sequence until the six bases 250 are pushed and pressurized on the three first built-in chambers 210 and the three second built-in chambers 220. Finally, the three groups of first built-in chambers 210 and second built-in chambers 220 are tightly aligned. The three segments of the stretched biological sample 400 are clamped and supported by three sets of reinforcing rings 530. The stretched biological sample 400 is then placed in three simulated chambers. The selected testing medium is then transferred to the three simulated chambers via the three liquid inlet tubes 270. The balloon catheter 600, which has been inserted into the middle of the biological sample 400 and expanded, can then perform compatibility tests on the three segments of the stretched biological sample 400 one by one. Testing equipment can be delivered to the three simulated chambers via the three test tubes 260, allowing for rapid collection of compatibility test data.

[0061] In the second stage, the spacing between the two sample-end locking outer parts 360 is controlled until the biological sample 400 tends to relax. In the above steps, the three sections of the relaxed biological sample 400 can be tightly clamped. At this time, the three sections of the relaxed biological sample 400 can simulate the tissue structure of a real organism when immersed in the same medium or different media, so that they can be used in conjunction with the balloon catheter 600 for multiple tests, and the biological compatibility can be determined by comparing the experimental data after multiple tests.

[0062] Example 2:

[0063] Combine Figure 4 and Figure 9 As shown, based on Example 1, the sealed protection mechanism 100 further includes a bracket 130 mounted on one end of the outer cover 110, two clamps 150 fixedly mounted on the top of the protective frame 140, a first screw rod 160 movably mounted inside the clamps 150, a second clamping sleeve 180 mounted on the top of the protective frame 140, and a first clamping sleeve 170 mounted on the protective frame 140;

[0064] Two symmetrically distributed sliding grooves 120 are provided at the bottom of the inner cavity of the outer cover 110;

[0065] The bracket 130 is composed of a T-shaped leg and a stud, and the stud is adapted to pass through the exterior of the auxiliary baffle 320 , and a nut provided on the stud is used to fix the auxiliary baffle 320 .

[0066] Preferably, a silicone layer is provided on the inner wall of the outer cover 110, and the protective frame 140 is made of an aluminum alloy material;

[0067] When the first screw rod 160 is reversed, the base 250 will extend outward along the threaded section of the first screw rod 160 , and the first internal compartment 210 or the second internal compartment 220 will be pulled and withdrawn outward from the interior of the protective frame 140 ;

[0068] When the first screw rod 160 rotates forward, the base 250 will shrink inward along the threaded section of the first screw rod 160 . At this time, the first built-in compartment 210 or the second built-in compartment 220 will be pressed to extend into the interior of the protective frame 140 .

[0069] Example 3:

[0070] Combine Figures 9 to 11 As shown, based on Example 1, the independent detection mechanism 200 further includes a drain pipe 230 installed in the hole at the bottom of the first built-in compartment 210, and a ball valve is provided inside the drain pipe 230, and a hose is provided at the outer end of the drain pipe 230;

[0071] A detection tube 260 and a liquid inlet tube 270 are provided on the top of the first built-in cabin 210 and the second built-in cabin 220. The liquid inlet tube 270 is used to guide the input of different detection media, and the detection tube 260 is used to provide an effective path for the detection equipment.

[0072] The number of the first built-in compartments 210 and the second built-in compartments 220 are both three;

[0073] Three bases 250 are installed outside the three first built-in compartments 210 , and the other three bases 250 are installed outside the three second built-in compartments 220 .

[0074] Preferably, the inner walls of the first built-in cabin 210 and the second built-in cabin 220 are both provided with a silicone layer, and the end of the booster plate 240 facing the inner side of the first built-in cabin 210 or the second built-in cabin 220 is also provided with a silicone layer;

[0075] The base 250 is fixed to the outside of the first built-in compartment 210 or the second built-in compartment 220 by two bolts, and a screw hole adapted for the first screw rod 160 is opened inside the top of the base 250;

[0076] When the ball valve inside the discharge pipe 230 is closed, the detection medium in the simulation chamber input through the liquid inlet pipe 270 and after the second built-in chamber 210 and 220 are closed will immerse the clamped part of the biological sample 400, and the part of the biological sample 400 in the detection medium can simulate the tissue organs in the organism. As the balloon catheter 600 is extended into the biological sample 400 and the balloon is located at a specified position inside the biological sample 400 and expands, the biological sample 400 is in a pressurized part, and the detection equipment after passing through the detection tube 260 applies the detection medium to the pressurized biological sample 400, and the directly released medium can be used to quickly detect the biological sample 400.

[0077] Example 4:

[0078] Combine Figures 2 to 8 As shown, in the above embodiment, the analog control mechanism 300 further includes two base plates 3104, two cover plates 340 provided at both ends of the slide rail 330, two second screw rods 350 movably mounted inside the two cover plates 340, two second screw rods 350 respectively provided on the threaded sections of the two sample end locking outer members 360, a compression bolt 3601 provided inside the sample end locking outer member 360, a slider 3604 movably mounted inside the two sample end locking inner members 3602, a clamping seat 3603 fixedly mounted on the outer wall of the sample end locking inner member 3602, a force arm 3605 movably mounted on the clamping seat 3603, and a third screw rod 3607 movably mounted inside the slider 3604;

[0079] The other end of the lever arm 3605 is movably mounted on a pad 3606;

[0080] The two bottom plates 3104 are fixedly mounted on the inner side of the main baffle 310 .

[0081] Preferably, the two cover plates 340 are fixedly mounted on both ends of the slide rail 330 by bolts, and the bottoms of both sides of the slide rail 330 are provided with pads, and the bolts provided in the pads are fixed in the bottom plate 3104;

[0082] The top of the slide rail 330 is provided with three sets of symmetrically distributed rectangular grooves, and each set of rectangular grooves is used to provide an effective extension path for the bottom of the first built-in compartment 210 and the second built-in compartment 220;

[0083] When the fixing bolt 3103 is loosened, the traction line 510 can move laterally along the inside of the main line sleeve 3102 and the secondary line sleeve 3201 until the six gaskets 520 fixed on the traction line 510 push the six reinforcing gaskets 530 to move laterally along the inside of the biological sample 400, until each group of reinforcing gaskets 530 moves to the selected position inside the biological sample 400, and then the fixing bolt 3103 can be tightened. As the balloon inside the balloon catheter 600 expands and applies an outward squeezing force to the inner wall of the biological sample 400, when the traction line 510 is compressed and in a continuous tension state, the anti-slip column head of the traction line 510 that passes through the outside of the secondary line sleeve 3201 will approach the secondary baffle 320. At this time, the sample lining mechanism 500 can provide support for the inner wall of the biological sample 400, and at the same time avoid interference with the expansion of the balloon at the inner end of the balloon catheter 600.

[0084] The working principle and use process of the present invention:

[0085] After the second screw rod 350 is tightened, the second end locking member 3602 is tightened and the second end locking member 3602 is tightened.

[0086] Next, the other second screw rod 350 is adjusted to reverse, and the other sample end locking outer member 360 is extended outward along the threaded section of the other second screw rod 350. Then, the other end of the biological sample 400 is fixed using another set of sample end locking outer members 360 and two sample end locking inner members 3602. As the other sample end locking outer member 360 continues to stretch outward, the tension of the biological sample 400 is adjusted until the entire biological sample 400 is straightened.

[0087] Then, the sample lining mechanism 500 is passed through the inner cavity of the straightened biological sample 400 until the multiple reinforcing rings 530 evenly distributed outside the traction line 510 provide internal support for the inner wall of the biological sample 400 at evenly spaced locations.

[0088] When it is necessary to perform a biocompatibility test on the balloon catheter 600 after it is inserted into the biological sample 400, the main baffle 310 and the auxiliary baffle 320 are inserted as a whole into the inner cavity of the outer cover 110, and then the six first screw rods 160 are adjusted to reverse, and the six bases 250 will retract inward along the six first screw rods 160. Finally, the three first built-in cabins 210 pushed by three of the bases 250 and the three second built-in cabins 220 pushed by the other three bases 250 can quickly lock the three selected parts of the biological sample 400. With the support of the three reinforcing gaskets 530 on the inner end of the booster plate 240, the parts of the biological sample 400 locked by the three sets of the first built-in cabins 210 and the second built-in cabins 220 can be placed in three independent simulation chambers.

[0089] The test solutions are transferred from the three liquid inlet tubes 270 into the three independent simulation chambers until the three test solutions are completely immersed in the three separated sections of the biological sample 400. Then, the balloon catheter 600 can be inserted into the middle of the inner cavity of the biological sample 400. When the balloon structure of the balloon catheter 600 moves into the interior of the biological sample 400, as the balloon structure at the inner end of the balloon catheter 600 continues to expand and exerts an outward squeezing force on the biological sample 400, the detectors extending into the three simulation chambers along the three detection tubes 260 can detect the pressure and tension coefficient of the compressed and outwardly expanded parts of the biological sample 400. By using the biological sample 400 as a substitute for biological tissue, the resistance of the expanded balloon catheter 600 to the expansion is tested.

[0090] The detection solutions injected into the above three simulation chambers can also be replaced with other media. By simulating the external biological tissue fluid and other environments of the three-section biological sample 400 after being tightened, the pressure resistance and compatibility of the balloon catheter 600 after gradual expansion can be tested according to the softening degree of the three-section biological sample 400 after being tightened in different media.

[0091] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the claims and their equivalents.

Claims

1. A balloon catheter biocompatibility testing device, comprising a sealed protection mechanism (100), characterized in that: The device further comprises three groups of independent detection mechanisms (200) disposed within the sealed protection mechanism (100), a simulation control mechanism (300) disposed within the sealed protection mechanism (100) and located between the three groups of independent detection mechanisms (200), a biological sample (400) disposed within the simulation control mechanism (300) and clamped therein, a sample lining mechanism (500) penetrating into the interior of the biological sample (400), and a balloon catheter (600), wherein the balloon catheter (600) is located in the middle of the inner cavity of the biological sample (400); The sealed protection mechanism (100) comprises an outer cover (110) and three protection frames (140) arranged inside the outer cover (110); The independent detection mechanism (200) comprises a first built-in cabin (210) disposed in a cavity at one end of the protective frame (140), and a second built-in cabin (220) disposed in a cavity at the other end of the protective frame (140), and both ends of the first built-in cabin (210) and the second built-in cabin (220) are equipped with a pressurizing plate (240) for providing a simulated chamber for the outer side of the biological sample (400) segment; The simulation control mechanism (300) includes a slide rail (330), two sample end locking outer parts (360) arranged inside the slide rail (330), and two sample end locking inner parts (3602) arranged on the sample end locking outer parts (360), and the number of the sample end locking inner parts (3602) is four; The two sample end locking outer pieces (360) and the four sample end locking inner pieces (3602) are used to lock the two ends of the biological sample (400) and adjust the tightness of the biological sample (400) after it is placed horizontally; The sample lining mechanism (500) includes six reinforcing rings (530), and two reinforcing rings (530) form a group, which are used to provide support for the inner wall of the biological sample (400) in sections; After the balloon catheter (600) is expanded, it is used to perform compatibility testing on the three separated sections of the biological sample (400); A detection tube (260) and a liquid inlet tube (270) are provided on the top of the first built-in cabin (210) and the second built-in cabin (220), wherein the liquid inlet tube (270) is used to guide the input of different detection media, and the detection tube (260) is used to provide an effective path for the detection equipment.

2. A balloon catheter biocompatibility testing device according to claim 1, characterized in that: The independent detection mechanism (200) further includes six bases (250) and a drain pipe (230) installed in a hole at the bottom of the first built-in cabin (210), wherein a ball valve is provided inside the drain pipe (230) and a hose is provided at the outer end of the drain pipe (230); The number of the first built-in compartments (210) and the number of the second built-in compartments (220) are both three; Three of the bases (250) are installed outside the three first built-in compartments (210), and the other three bases (250) are installed outside the three second built-in compartments (220).

3. The balloon catheter biocompatibility testing device according to claim 1, characterized in that: The analog control mechanism (300) further comprises two cover plates (340) arranged at both ends of the slide rail (330), two second screw rods (350) movably mounted inside the two cover plates (340), two sample end locking outer members (360) respectively arranged on the threaded sections of the two second screw rods (350), a compression bolt (3601) arranged inside the sample end locking outer member (360), a slider (3604) movably mounted inside the two sample end locking inner members (3602), a clamping seat (3603) fixedly mounted on the outer wall of the sample end locking inner member (3602), a force arm (3605) movably mounted on the clamping seat (3603), and a third screw rod (3607) movably mounted inside the slider (3604); The other end of the lever arm (3605) is movably mounted on a cushion (3606).

4. The balloon catheter biocompatibility testing device according to claim 1, characterized in that: The sealed protection mechanism (100) further includes a bracket (130) mounted on one end of the outer cover (110), two clamps (150) fixedly mounted on the top of the protection frame (140), a first screw rod (160) movably mounted inside the clamps (150), a second clamp (180) mounted on the top of the protection frame (140), and a first clamp (170) mounted on the protection frame (140); Two symmetrically distributed sliding grooves (120) are provided at the bottom of the inner cavity of the outer cover (110).

5. The balloon catheter biocompatibility testing device according to claim 1, characterized in that: The analog control mechanism (300) further comprises a main baffle (310), a pipe sleeve (3101) arranged in the main baffle (310), a main line sleeve (3102) installed in the main baffle (310), a fixing bolt (3103) arranged in the main line sleeve (3102), and a secondary line sleeve (3201) installed in the secondary baffle (320); The interior of the tube sleeve (3101) is provided with a through hole for inserting the guiding balloon catheter (600).

6. The balloon catheter biocompatibility testing device according to claim 1, characterized in that: The sample lining mechanism (500) further comprises a traction line (510) movably mounted inside the six reinforcing gaskets (530) and six gaskets (520) fixedly mounted on the traction line (510).

7. The balloon catheter biocompatibility testing device according to claim 5, characterized in that: The main line sleeve (3102) and the auxiliary line sleeve (3201) are both provided with a transverse hole constrained by the traction line (510); One end of the traction line (510) passing through the secondary line sleeve (3201) is provided with an anti-slip stud.

8. The balloon catheter biocompatibility testing device according to claim 4, characterized in that: The bracket (130) is composed of a T-shaped leg and a stud, and the stud is adapted to penetrate the outside of the auxiliary baffle (320), and a nut provided on the stud is used to fix the auxiliary baffle (320).

9. The balloon catheter biocompatibility testing device according to claim 1, characterized in that: A semicircular rubber pad is provided in the arc-shaped notch on the inner side of the pressurizing plate (240), and the semicircular rubber pad is used to press the outer wall of the biological sample (400).

10. The balloon catheter biocompatibility testing device according to claim 5, characterized in that: The simulation control mechanism (300) further comprises two bottom plates (3104), and the two bottom plates (3104) are fixedly mounted on the inner side of the main baffle (310).

Citation Information

Patent Citations

  • Pelvic balloon tamponade

    CN101657164A

  • Anti-HIV JB protein rectum gel preparation and preparation method thereof

    CN104983673A