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 convenient compatibility testing and data acquisition are achieved.

CN120254194AActive Publication Date: 2025-07-04JIANGSU KEBIAO MEDICAL TECH GRP CO LTD
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Patent Information

Application Number
CN202510728172.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-03
Publication Date
2025-07-04
Estimated Expiration
2045-06-03

AI Technical Summary

Technical Problem

In the prior art, the biocompatibility test of balloon catheters has the problem that the risk factor is high and it is difficult to collect detection data.

Method used

A balloon catheter biocompatibility testing device is designed, including a closed protection mechanism, an independent detection mechanism and a simulation control mechanism. The biological sample is clamped through the simulation control 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.

Benefits of technology

It realizes safe and convenient collection of compatibility data between the balloon catheter and biological samples, simulates the tissue status in the organism, supports multiple types of comparison tests, and simplifies the data acquisition process.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of balloon catheter testing, in particular to a balloon catheter biocompatibility testing device which comprises a closed protection mechanism, three sets of independent detection mechanisms arranged in the closed protection mechanism and a simulation regulation and control mechanism arranged in the closed protection mechanism and located among the three sets of independent detection mechanisms. A closed protection mechanism is arranged, a simulation regulation and control mechanism is arranged in the closed protection mechanism, a biological sample is clamped by utilizing the simulation regulation and control mechanism, the biological sample is tensioned in a gradual change degree in combination with the simulation regulation and control mechanism, and three independent simulation chambers are arranged outside the biological sample; after different detection media are selectively injected into the three simulation chambers, the balloon catheter extends into the biological sample and performs targeted test on the compatibility of the three pretreated parts after expanding, and the test result can be quickly transmitted outwards through the three simulation chambers, so that data acquisition is facilitated.
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Description

Technical Field

[0001] The present invention relates to the technical field of balloon catheter testing, and specifically to a balloon catheter biocompatibility testing device. Background Technique

[0002] The balloon catheter is used to assist the insertion of an intravascular catheter and is guided into the target blood vessel of the carotid artery. During angiography or other procedural operations, the balloon can provide a temporary vascular occlusion effect. The balloon catheter can also be used as a passage for a retrieval device.

[0003] After production, the balloon catheter needs to be subjected to fatigue testing, high-pressure testing, diameter, filling pressure and other tests. These tests only detect the performance of the equipment itself. Since the balloon catheter needs to be inserted into the patient's body, the balloon catheter inserted into the patient's body needs to be subjected to biocompatibility testing. However, the risk factor of using direct biological testing is relatively large, and the difficulty is relatively high, and the detection 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] For this reason, the technical solution adopted by the present invention is as follows: A balloon catheter biocompatibility testing device includes a closed protection mechanism, three independent detection mechanisms arranged in the closed protection mechanism, a simulation regulation mechanism arranged in the closed protection mechanism and located between the three independent detection mechanisms, a biological sample clamped in the simulation regulation mechanism, a sample lining mechanism and a balloon catheter penetrating into the biological sample, and the balloon catheter is located in the middle of the inner cavity of the biological sample; the closed protection mechanism includes an outer cover and three protective frames arranged in the outer cover; the independent detection mechanism includes a first built-in chamber arranged in the cavity at one end of the protective frame, a second built-in chamber arranged in the cavity at the other end of the protective frame, and pressure boosting plates are installed at both ends of the first built-in chamber and the second built-in chamber to provide a simulation chamber for the outside of the segmented biological sample; the simulation regulation 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 both ends of the biological sample and adjust the tightness of the biological sample after being placed horizontally; the sample lining mechanism includes six reinforcing pad rings, and two reinforcing pad rings form a group to provide support for the inner wall of the segmented biological sample; after the balloon catheter expands, it is used to perform biocompatibility testing on the three segments of the biological sample separated.

[0007] In a preferred example, the present invention can be further configured as follows: The independent detection mechanism further includes six bases and a drain pipe installed in the holes at the bottom of the first inner cabin, and a ball valve is arranged inside the drain pipe, and a hose is arranged at the outer end of the drain pipe; Detection pipes and liquid inlet pipes are arranged at the tops of the first inner cabin and the second inner cabin, and the liquid inlet pipe is used to guide the input of different detection media, and the detection pipe is used to provide an effective path for the detection equipment; The number of both the first inner cabin and the second inner cabin is three; Three of the bases are installed outside the three first inner cabins, and the other three bases are installed outside the three second inner cabins.

[0008] In a preferred example, the present invention can be further configured as follows: The simulation regulation mechanism further includes two cover plates arranged at both ends of the slide rail, two second lead screws movably installed inside the two cover plates, and two sample end locking outer parts are respectively arranged on the threaded sections of the two second lead screws, a compression bolt arranged inside the sample end locking outer part, a slider movably installed inside the two sample end locking inner parts, a clamp seat fixedly installed on the outer wall of the sample end locking inner part, a force arm movably installed on the clamp seat, a third lead screw movably installed inside the slider, and; The other end of the force arm is movably installed on the cushioning part.

[0009] In a preferred example, the present invention can be further configured as follows: The airtight protection mechanism further includes a bracket installed at one end of the outer cover, two chucks fixedly installed on the top of the protection frame, a first lead screw movably installed inside the chucks, a second clamping sleeve installed on the top of the protection frame, and a first clamping sleeve installed on the protection frame; Two symmetrically distributed chutes are opened at the bottom of the inner cavity of the outer cover.

[0010] In a preferred example, the present invention can be further configured as follows: The simulation regulation mechanism further includes a main baffle, a tube sleeve arranged inside the main baffle, a main wire sleeve installed inside the main baffle, a fixing bolt arranged inside the main wire sleeve, and a secondary wire sleeve installed inside the secondary baffle; A through hole for guiding the balloon catheter to extend is opened inside the tube sleeve.

[0011] In a preferred example, the present invention can be further configured as follows: The sample inner lining mechanism further includes a traction wire movably installed inside six reinforcing gasket rings and six gaskets fixedly installed on the traction wire.

[0012] In a preferred example, the present invention can be further configured as follows: Transverse holes for restricting the traction wire are opened inside both the main wire sleeve and the secondary wire sleeve; An anti - detachment head is arranged at one end of the traction wire passing through to the secondary wire sleeve.

[0013] In a preferred embodiment, 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 penetrate through to the outside of the secondary baffle, and a nut provided on the stud is used to fix the secondary baffle.

[0014] In a preferred embodiment, the present invention can be further configured as follows: A semi-circular rubber cushion layer is provided in the arc-shaped notch on the inner side of the pressure increasing plate, and the semi-circular rubber cushion layer is used to press against the outer wall of the biological sample.

[0015] In a preferred embodiment, the present invention can be further configured as follows: The simulation regulation mechanism further includes two bottom plates, and the two bottom plates are fixedly installed on the inner side of the main baffle.

[0016] By adopting the above technical solutions, the beneficial effects achieved by the present invention are as follows: 1. By providing a closed protection mechanism and a simulation regulation mechanism inside the closed protection mechanism, the present invention uses the simulation regulation mechanism to clamp the biological sample, combines the simulation regulation mechanism to tighten the biological sample with a gradual degree, and sets three independent simulation chambers outside the biological sample. After different detection media are selectively injected into the three simulation chambers, the balloon catheter extends into the biological sample and conducts targeted tests on the compatibility of the three pretreated parts after outward expansion, and the test results can be quickly conveyed out through the three simulation chambers, thus facilitating data collection.

[0017] 2. By adjusting the tension degree of the simulation regulation mechanism for the horizontally placed biological sample selectively, the three parts of the biological sample clamped by multiple reinforcing pad rings, three groups of first inner cabins and the second inner cabin can simulate the real-time state of tissues in the organism. After being immersed in different detection media, the three parts of the biological sample in different loosening states can be subjected to multi-type comparison tests.

[0018] 3. By using the traction wire and multiple gaskets outside it to control the distribution state of multiple reinforcing pad rings inside the biological sample, when the length of the biological sample to be detected needs to be changed, two of the reinforcing pad rings can be introduced into a group of independent detection mechanisms near the outer end of the outer cover. After the balloon catheter expands, the traction wire will not interfere with the expansion of the airbag and will not hinder the real-time compression of the biological sample either. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is a schematic diagram when the present invention is in use; Figure 2 is a three-dimensional schematic diagram of the present invention; Figure 3 is an exploded schematic diagram of the present invention; Figure 4 is a schematic diagram of the closed protection mechanism of the present invention; Figure 5 For the present invention Figure 2 Partial explosion schematic diagram; Figure 6 Explosion schematic diagram of the simulation regulation mechanism of the present invention; Figure 7 For the present invention Figure 6 Partial explosion schematic diagram; Figure 8 For the present invention Figure 7 Enlarged schematic diagram at position A in the present invention; Figure 9 Explosion schematic diagram of the independent detection mechanism of the present invention; Figure 10 For the present invention Figure 9 Enlarged schematic diagram at position B in the present invention; Figure 11 For the present invention Figure 9 Partial explosion schematic diagram.

[0020] Reference numerals: 100, airtight protection mechanism; 110, outer cover; 120, sliding groove; 130, support; 140, protective frame; 150, chuck; 160, first lead screw; 170, first clamping sleeve; 180, second clamping sleeve; 200, independent detection mechanism; 210, first built-in cabin; 220, second built-in cabin; 230, drain pipe; 240, pressure increasing plate; 250, base; 260, detection pipe; 270, inlet pipe; 300, simulation regulation mechanism; 310, main baffle; 3101, pipe sleeve; 3102, main wire sleeve; 3103, fixing bolt; 3104, bottom plate; 320, sub-baffle; 3201, sub-wire sleeve; 330, slide rail; 340, cover plate; 350, second lead screw; 360, sample end locking outer part; 3601, pressing bolt; 3602, sample end locking inner part; 3603, clamping seat; 3604, slider; 3605, lever arm; 3606, gasket; 3607, third lead screw; 400, biological sample; 500, sample lining mechanism; 510, traction wire; 520, gasket; 530, reinforcing gasket ring; 600, balloon catheter. Detailed implementation manners

[0021] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below in conjunction with the specific implementation manners and with reference to the accompanying drawings. It should be noted that, without conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

[0022] It should be understood that these descriptions are only exemplary and are not intended to limit the scope of the present invention.

[0023] The following describes a balloon catheter biocompatibility testing device provided by some embodiments of the present invention in conjunction with the accompanying drawings.

[0024] Embodiment 1: Combined with Figures 1 to 11 As shown, a balloon catheter biocompatibility testing device provided by the present invention includes a closed protection mechanism 100, three groups of independent detection mechanisms 200 arranged in the closed protection mechanism 100, a simulation regulation mechanism 300 arranged in the closed protection mechanism 100 and located between the three groups of independent detection mechanisms 200, a biological sample 400 clamped in the simulation regulation mechanism 300, a sample lining mechanism 500 and a balloon catheter 600 penetrating into the interior of the biological sample 400, and the balloon catheter 600 is located in the middle of the inner cavity of the biological sample 400. The closed protection mechanism 100 is used to provide a sufficiently stable support platform for the three groups of independent detection mechanisms 200 and provide closed protection for the simulation regulation mechanism 300. The three groups of independent detection mechanisms 200 are used to clamp three selected segments of the biological sample 400 and provide a simulation chamber for the three clamped segments. The simulation regulation mechanism 300 is used to adjust the tightness of the biological sample 400 to simulate the changes of biological tissues. The sample lining mechanism 500 is applied 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 three selected segments of the biological sample 400 and conduct biocompatibility tests.

[0025] The closed protection mechanism 100 includes an outer cover 110 and three protective frames 140 arranged inside the outer cover 110; The independent detection mechanism 200 includes six bases 250, a first built-in cabin 210 arranged in the cavity at one end of the protective frame 140, a second built-in cabin 220 arranged in the cavity at the other end of the protective frame 140, and pressure increasing plates 240 are installed at both ends of the first built-in cabin 210 and the second built-in cabin 220. A semi-circular rubber cushion layer is arranged in the arc-shaped notch on the inner side of the pressure increasing plate 240, and the semi-circular rubber cushion layer is used to press the outer wall of the biological sample 400; The simulation regulation mechanism 300 includes a main baffle 310 and a slide rail 330, two sample end locking outer parts 360 arranged inside the slide rail 330, 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. A pipe sleeve 3101 is arranged in the main baffle 310, a main wire sleeve 3102 is installed in the main baffle 310, a fixing bolt 3103 is arranged inside the main wire sleeve 3102, and a sub-wire sleeve 3201 is arranged inside the sub-baffle 320; The two sample end locking outer parts 360 and the four sample end locking inner parts 3602 are used to lock both ends of the biological sample 400 and adjust the tightness of the biological sample 400 after being placed horizontally; The sample inner lining mechanism 500 includes six reinforcing gasket rings 530, a traction wire 510 movably installed inside the six reinforcing gasket rings 530, and six gaskets 520 fixedly installed on the traction wire 510. And two reinforcing gasket rings 530 form a group for providing support to the inner wall of the biological sample 400 in segments. A through hole for guiding the balloon catheter 600 to extend is provided inside the pipe sleeve 3101. Transverse holes for restricting the traction wire 510 are provided inside both the main wire sleeve 3102 and the auxiliary wire sleeve 3201. An anti - detachment head is provided at one end of the traction wire 510 that penetrates through to the auxiliary wire sleeve 3201.

[0026] Loosen the two compression bolts 3601, control the two third lead screws 3607 to reverse, then respectively penetrate the two ends of the biological sample 400 into the inner sides of the two sample - end locking outer parts 360, and use the four sample - end locking inner parts 3602 to fix the two ends of the biological sample 400 inside the two sample - end locking outer parts 360. In the first stage, control the two second lead screws 350 to rotate forward until the two sample - end locking outer parts 360 extend outward along the threaded sections of the two second lead screws 350. Finally, the two sample - end locking outer parts 360 cooperate with the four sample - end locking inner parts 3602 to tighten the horizontally placed biological sample 400. And the tightened biological sample 400 needs to be delivered into the interior of the outer cover 110. Then, adjust the six first lead screws 160 in sequence until the six bases 250 are boosted to press on the three first built - in cabins 210 and the three second built - in cabins 220. Finally, the three groups of first built - in cabins 210 and second built - in cabins 220 clamp the three tightened segments of the biological sample 400. With the support of the three groups of reinforcing gasket rings 530 for the three tightened segments of the biological sample 400, at this time, the three tightened segments of the biological sample 400 will be in the three simulation chambers. Then, transfer the selected detection medium to the three simulation chambers through the three liquid inlet pipes 270. The balloon catheter 600 that penetrates into the middle of the inner cavity of the biological sample 400 and expands in area can conduct compatibility tests on the three tightened segments of the biological sample 400 one by one. The test equipment can be delivered into the three simulation chambers through the three detection pipes 260. Finally, the data of the compatibility test can be quickly collected. In the second stage, by controlling the distance between the two sample - end locking outer parts 360 until the biological sample 400 tends to be relaxed. Under the above steps, the three relaxed segments of the biological sample 400 can be hermetically clamped. At this time, the three relaxed segments of the biological sample 400 can simulate the tissue structure of real organisms when soaked in the same medium or different media, so that multiple detections can be carried out in cooperation with the balloon catheter 600, and the biocompatibility can be determined by comparing the experimental data after multiple detections.

[0027] Example 2: Combined Figure 4 and Figure 9 As shown, on the basis of Embodiment 1, the airtight protection mechanism 100 further includes a bracket 130 installed at one end of the outer cover 110, two chucks 150 fixedly installed on the top of the protective frame 140, a first lead screw 160 movably installed inside the chucks 150, a second jacket 180 installed on the top of the protective frame 140, and a first jacket 170 installed on the protective frame 140; Two symmetrically distributed chutes 120 are provided at the bottom of the inner cavity of the outer cover 110; The bracket 130 is composed of a T-shaped leg and a stud, and the stud is adaptively penetrated to the outside of the auxiliary baffle 320, and the nut provided on the stud is used to fix the auxiliary baffle 320.

[0028] Preferably, the inner wall of the outer cover 110 is provided with a silica gel layer, and the protective frame 140 is made of aluminum alloy material; When the first lead screw 160 rotates reversely, the base 250 will extend outward along the threaded section of the first lead screw 160. At this time, the first inner cabin 210 or the second inner cabin 220 will be pulled and withdrawn from the inside of the protective frame 140; When the first lead screw 160 rotates forward, the base 250 will contract inward along the threaded section of the first lead screw 160. At this time, the first inner cabin 210 or the second inner cabin 220 will be pressed and extended into the inside of the protective frame 140.

[0029] Embodiment 3: Combined Figures 9 to 11 As shown, on the basis of Embodiment 1, the independent detection mechanism 200 further includes a drain pipe 230 installed in the bottom hole of the first inner cabin 210, a ball valve is provided inside the drain pipe 230, and a hose is provided at the outer end of the drain pipe 230; Detection pipes 260 and liquid inlet pipes 270 are provided at the tops of the first inner cabin 210 and the second inner cabin 220. The liquid inlet pipe 270 is used to guide the input of different detection media, and the detection pipe 260 is used to provide an effective path for the detection equipment; The number of both the first inner cabin 210 and the second inner cabin 220 is three; Among them, three bases 250 are installed outside the three first inner cabins 210, and the other three bases 250 are installed outside the three second inner cabins 220.

[0030] Preferably, the inner walls of both the first inner cabin 210 and the second inner cabin 220 are provided with silica gel layers, and the end of the pressure increasing plate 240 facing the inside of the first inner cabin 210 or the second inner cabin 220 is also provided with a silica gel layer; Among them, the base 250 is fixed to the outside of the first inner cabin 210 or the second inner cabin 220 by two bolts, and a screw hole adapted to the first lead screw 160 is provided inside the top end of the base 250; When the ball valve inside the drain pipe 230 is closed, the detection medium in the simulation chamber after the first internal chamber 210 and the second internal chamber 220 are closed through the liquid inlet pipe 270 will immerse the clamped part of the biological sample 400. The part of the biological sample 400 in the detection medium can simulate the tissues and organs in the living body. As the balloon catheter 600 extends into the biological sample 400 and the balloon expands at a specified position inside the biological sample 400, the part of the biological sample 400 under pressure. After the detection equipment after the detection pipe 260 acts on the biological sample 400 under pressure with the detection medium, the directly released medium can be used to quickly detect the biological sample 400.

[0031] Example 4: Combined with Figures 2 to 8 As shown, in the above embodiment, the simulation control mechanism 300 further includes two bottom plates 3104, two cover plates 340 provided at both ends of the slide rail 330, two second lead screws 350 movably installed inside the two cover plates 340, two second lead screws 350 respectively provided on the threaded sections of the two sample end locking outer parts 360, a compression bolt 3601 provided inside the sample end locking outer part 360, a slider 3604 movably installed inside the two sample end locking inner parts 3602, a clamp seat 3603 fixedly installed on the outer wall of the sample end locking inner part 3602, a force arm 3605 movably installed on the clamp seat 3603, and a third lead screw 3607 movably installed inside the slider 3604; The other end of the force arm 3605 is movably installed on the cushion 3606; And the two bottom plates 3104 are fixedly installed on the inner side of the main baffle 310.

[0032] Preferably, the two cover plates 340 are fixedly installed at both ends of the slide rail 330 by bolts, and cushion feet are provided at the bottoms on both sides of the slide rail 330, and the bolts provided inside the cushion feet are fixed inside the bottom plate 3104; Among them, three groups of symmetrically distributed rectangular grooves are opened at the top of the slide rail 330, and each group of rectangular grooves is used to provide an effective stretching path for the bottoms of the first internal chamber 210 and the second internal chamber 220; 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 stretching 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.

[0033] The working principle and use process of the present invention: Pre-loosen the clamping bolt 3601 and adjust the third screw rod 3607 to reverse. At this time, the cushion 3606 will move laterally along the threaded section of the third screw rod 3607 toward the two sample end locking inner pieces 3602. At this time, the two sample end locking inner pieces 3602 will expand outward under pressure. At the same time, adjust one of the second screw rods 350 to rotate forward, and one of the sample end locking outer pieces 360 will move outward along the second screw rod 350 at that location. Then, extend one end of the biological sample 400 into the annular notch at the top of the sample end locking outer piece 360. At this time, the two sample end locking inner pieces 3602 penetrate into the two end plates in the annular notch and fit the two sides of the inner wall of the biological sample 400. Then, control the clamping bolt 3601 to rotate forward and adjust the third screw rod 3607 to rotate forward. At this time, the two sample end locking inner pieces 3602 cooperate with the sample end locking outer piece 360 ​​to lock and fix one end of the biological sample 400. Then, the other second screw rod 350 is adjusted to reverse, and at this time, the other sample end locking outer member 360 will stretch outward along the threaded section of the other second screw rod 350, and then the other end of the biological sample 400 is fixed by 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 can be adjusted until the whole biological sample 400 is straightened; Then, the sample lining mechanism 500 is passed through the inner cavity of the straightened biological sample 400 as a whole, until the multiple reinforcing rings 530 evenly distributed outside the traction line 510 provide internal support for the evenly spaced locations on the inner wall of the biological sample 400; When a biocompatibility test is required after the balloon catheter 600 extends into the biological sample 400, the main baffle 310 and the auxiliary baffle 320 are inserted into the inner cavity of the outer cover 110 as a whole. Then, six first lead screws 160 are adjusted to reverse, and six bases 250 will contract inward along the six first lead screws 160. Finally, three first inner cabins 210 boosted by three of the bases 250 and three second inner cabins 220 boosted by the other three bases 250 can quickly lock three selected parts of the biological sample 400. With the support of three reinforcing gasket rings 530 for the inner end of the pressure increasing plate 240, the parts of the biological sample 400 locked in the closed cavities by the three groups of first inner cabins 210 and second inner cabins 220 can be in three independent simulation chambers; Transfer the detection solution from the three liquid inlet pipes 270 into the three independent simulation chambers until the three detection solutions completely submerge the three separated sections of the biological sample 400. Then, the balloon catheter 600 can be extended into the middle of the inner cavity of the biological sample 400. When the balloon structure of the balloon catheter 600 moves into the biological sample 400, after the balloon structure at the inner end of the balloon catheter 600 continuously expands and applies an outward extrusion force to a local part of the biological sample 400, the detector extending into the three simulation chambers along the three detection pipes 260 can detect the pressure and the tension coefficient of the part of the biological sample 400 that is pressed and expands outward, and detect the resistance to the expanded balloon catheter 600 by using the biological sample 400 instead of biological tissue; The detection solutions injected into the above three simulation chambers can also be replaced by other media. By simulating the environment such as biological tissue fluid outside the three tightened sections of the biological sample 400, the compressive resistance and compatibility of the balloon catheter 600 after gradual inflation can be detected according to the softening degree of the three tightened sections of the biological sample 400 in different media.

[0034] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and purposes of the present invention. The scope of the present invention is defined by the claims and their equivalents.

Claims

1. A balloon catheter biocompatibility testing device, comprising a closed protection mechanism (100), characterized in that, It also includes three groups of independent detection mechanisms (200) arranged within the airtight protection mechanism (100), a simulation regulation mechanism (300) arranged within the airtight protection mechanism (100) and located between the three groups of independent detection mechanisms (200), a biological sample (400) arranged within the simulation regulation mechanism (300) and clamped therein, a sample lining mechanism (500) and a balloon catheter (600) penetrating into the interior of the biological sample (400), and the balloon catheter (600) is located in the middle of the inner cavity of the biological sample (400); The airtight protection mechanism (100) includes an outer cover (110) and three protective frames (140) arranged within the outer cover (110); The independent detection mechanism (200) includes a first built-in chamber (210) arranged within the cavity at one end of the protective frame (140), a second built-in chamber (220) arranged within the cavity at the other end of the protective frame (140), and pressure increasing plates (240) are installed at both ends of the first built-in chamber (210) and the second built-in chamber (220) to provide a simulation chamber for the outer side of the segmented biological sample (400); The simulation regulation mechanism (300) includes a slide rail (330), two sample end locking outer members (360) arranged within the slide rail (330), and two sample end locking inner members (3602) arranged on the sample end locking outer members (360), and the number of the sample end locking inner members (3602) is four; The two sample end locking outer members (360) and the four sample end locking inner members (3602) are used to lock both ends of the biological sample (400) and adjust the tightness of the biological sample (400) after being placed horizontally; The sample lining mechanism (500) includes six reinforcing gasket rings (530), and two reinforcing gasket rings (530) form a group to provide support for the inner wall of the segmented biological sample (400); After the balloon catheter (600) expands, it is used to conduct a compatibility test on the three segments of the biological sample (400) after being separated; 2. The balloon catheter biocompatibility testing device according to claim 1, wherein The independent detection mechanism (200) also includes six bases (250) and a drain pipe (230) installed within the bottom hole of the first built-in chamber (210), a ball valve is arranged within the drain pipe (230), and a hose is arranged at the outer end of the drain pipe (230); Detection pipes (260) and liquid inlet pipes (270) are arranged at the tops of the first built-in chamber (210) and the second built-in chamber (220), and the liquid inlet pipe (270) is used to guide the input of different detection media, and the detection pipe (260) is used to provide an effective path for detection equipment; The number of both the first built-in chamber (210) and the second built-in chamber (220) is three; Three of the bases (250) are installed outside the three first built-in chambers (210), and the other three bases (250) are installed outside the three second built-in chambers (220).

3. The biocompatibility testing device for a balloon catheter according to claim 1, wherein The simulation regulation mechanism (300) further includes two cover plates (340) arranged at both ends of the slide rail (330), two second lead screws (350) movably installed inside the two cover plates (340), and two sample end locking outer members (360) respectively arranged on the threaded sections of the two second lead screws (350), a pressing bolt (3601) arranged inside the sample end locking outer member (360), a slider (3604) movably installed inside the two sample end locking inner members (3602), a clamping seat (3603) fixedly installed on the outer wall of the sample end locking inner member (3602), a force arm (3605) movably installed on the clamping seat (3603), and a third lead screw (3607) movably installed inside the slider (3604); The other end of the force arm (3605) is movably installed on the cushioning member (3606).

4. The balloon catheter biocompatibility testing device according to claim 1, characterized in that, The airtight protection mechanism (100) further includes a bracket (130) installed at one end of the outer cover (110), two chucks (150) fixedly installed on the top of the protective frame (140), a first lead screw (160) movably installed inside the chuck (150), a second clamping sleeve (180) installed on the top of the protective frame (140), and a first clamping sleeve (170) installed on the protective frame (140); Two symmetrically distributed chutes (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 simulation regulation mechanism (300) further includes a main baffle (310), a tube sleeve (3101) arranged inside the main baffle (310), a main wire sleeve (3102) installed inside the main baffle (310), a fixing bolt (3103) arranged inside the main wire sleeve (3102), and a secondary wire sleeve (3201) installed inside the secondary baffle (320); A through hole for the guiding balloon catheter (600) to extend into is provided inside the tube sleeve (3101).

6. The biocompatibility testing device for a balloon catheter according to claim 1, wherein The sample inner lining mechanism (500) further includes a traction wire (510) movably installed inside six reinforcing gasket rings (530) and six gasket members (520) fixedly installed on the traction wire (510).

7. The biocompatibility testing device for a balloon catheter according to claim 5, characterized in that, Horizontal holes for restricting the traction wire (510) are provided inside both the main wire sleeve (3102) and the secondary wire sleeve (3201); An anti - detachment stud is provided at one end of the traction wire (510) passing through to the secondary wire sleeve (3201).

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 through the outside of the secondary baffle (320), and a nut provided on the stud is used to fix the secondary baffle (320).

9. The balloon catheter biocompatibility testing device according to claim 1, characterized in that, A semi - circular rubber cushion layer is provided in the arc - shaped notch on the inner side of the pressure - increasing plate (240), and the semi - circular rubber cushion layer is used to press against the outer wall of the biological sample (400).

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

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