Integrated fixing and pressure applying device for amniotic membrane bubble pressure and stress test

Abstract

This invention discloses an integrated fixation and pressure device for testing the pressure and stress of amniotic bulges, relating to the field of biomedical testing equipment technology. The integrated fixation and pressure device includes a constraint part and a tension part. The constraint part has a test hole for covering and sealing the amniotic membrane. The constraint part clamps and fixes the amniotic membrane at the circumferential edge of the test hole. The tension part is connected to the constraint part and has a hollow chamber with an end opening. When the test hole is covered by the amniotic membrane, the amniotic membrane can seal the end opening of the hollow chamber. The constraint part provides stable and uniform edge constraint to the amniotic membrane, thereby improving the reliability of the test results. Furthermore, by filling the hollow chamber with fluid and changing the fluid pressure within the hollow chamber, precise and repeatable adjustment of the amniotic membrane tension can be achieved, improving the applicability of the integrated fixation and pressure device for testing the pressure and stress of amniotic bulges.

Description

Technical Field

[0001] This invention relates to the field of biomedical testing equipment technology, and in particular to an integrated fixation and pressure application device for testing the pressure and stress of amniotic bulges. Background Technology

[0002] Amniotic membrane, as a high-performance natural biomaterial, has been widely used in biomedical fields such as tissue engineering, wound repair, and ophthalmic surgery due to its excellent biocompatibility, biodegradability, and anti-inflammatory and repair properties. In the clinical translation and product development of amniotic membrane, accurately measuring its mechanical properties under pressure, such as stress-strain relationship, compressive strength, and elastic recovery capacity, is a core step in evaluating its application safety and effectiveness.

[0003] However, the industry has not yet developed a mechanical testing device specifically adapted to the properties of amniotic membrane materials. When conducting mechanical tests on amniotic membrane materials, clinical fixators or mechanical clamps designed to meet the needs of clinical surgery are often used to clamp and fix the amniotic membrane at multiple points. On the one hand, local stress concentration is easily generated at the contact points. In pressure test scenarios such as planar compression and puncture, it is impossible to provide stable and uniform edge constraints for the amniotic membrane, affecting the reliability of the test results. On the other hand, there is a lack of a mechanism for precise and repeatable adjustment of the initial tension of the amniotic membrane, which cannot meet the prerequisites for comparable mechanical tests such as creep and stress relaxation, thus affecting the applicability of mechanical testing devices. Summary of the Invention

[0004] The purpose of this invention is to provide an integrated fixation and pressure device for amniotic bulging pressure testing, so as to solve the problems existing in the prior art, improve the reliability of amniotic mechanics test results and the applicability of the integrated fixation and pressure device for amniotic bulging pressure testing.

[0005] To achieve the above objectives, the present invention provides the following solution: This invention provides an integrated fixing and pressure application device for amniotic membrane blistering pressure stress testing, comprising a constraint part and a tension part. The constraint part has a test hole for covering and closing the amniotic membrane. The constraint part is used to clamp and fix the amniotic membrane at the circumferential edge of the test hole. The tension part is connected to the constraint part and has a hollow chamber with an end opening. When the test hole is covered by the amniotic membrane, the amniotic membrane can close the end opening of the hollow chamber. Fluid can be filled into the hollow chamber to apply tension to the amniotic membrane.

[0006] In some embodiments, the constraint portion includes a detachably connected first constraint member and a second constraint member, both of which have at least partially mating planes. The test hole is formed on the mating plane of the first constraint member and the second constraint member, and on the mating plane of the second constraint member and the first constraint member. The test hole on the first constraint member and the test hole on the second constraint member are aligned with each other.

[0007] In some embodiments, the tensioning part includes a housing with a hollow cavity formed inside. One end of the housing is open, and the edge of the open end of the housing is fixedly connected to the second constraint member. The opening of the housing is aligned with the test hole provided on the second constraint member. A fluid port is also provided on the side wall of the hollow cavity for filling or discharging fluid into or out of the hollow cavity.

[0008] In some embodiments, the housing is hemispherical, and the fluid port is located on the side wall of the hollow chamber away from the opening end.

[0009] In some embodiments, an exhaust port is also provided on the side wall of the hollow chamber.

[0010] In some embodiments, an annular sealing portion is provided between the first constraint member and the second constraint member, the sealing portion being coaxial with the test hole, and the sealing portion being capable of sealing the gap between the planes of the first constraint member and the second constraint member located at the circumferential edges of the test hole that are in contact with each other.

[0011] In some embodiments, the sealing portion includes an annular protrusion fixedly disposed on the first constraint member and an annular groove fixedly disposed on the second constraint member, wherein when the first constraint member and the second constraint member are connected, the annular protrusion is embedded in the annular groove.

[0012] In some embodiments, a water-swellable sealing material is provided in the annular groove.

[0013] In some embodiments, the integrated fixing and pressure application device for amniotic blistering pressure testing further includes a support frame, the end of which is fixedly connected to the second constraint member, and the tension portion is disposed inside the support frame.

[0014] The present invention achieves the following technical effects compared to the prior art: The purpose of this invention is to provide an integrated fixing and pressurizing device for amniotic membrane blistering pressure testing. The device uses a constraint part to clamp and fix the amniotic membrane at the circumferential edge of the test hole. The amniotic membrane covers and seals the test hole and the top opening of the tension part. When performing mechanical testing on the amniotic membrane at the test hole, the constraint part provides stable and uniform edge constraint, thereby improving the reliability of the test results. Furthermore, through the connection between the tension part and the constraint part, when the test hole is covered by the amniotic membrane, the amniotic membrane can seal the end opening of the hollow cavity. By filling the hollow cavity with fluid, tension is generated in the amniotic membrane. By changing the fluid pressure within the hollow cavity, precise and repeatable adjustment of the amniotic membrane tension can be achieved, meeting the prerequisites for comparable mechanical tests such as creep and stress relaxation. This improves the applicability of the integrated fixing and pressurizing device for amniotic membrane blistering pressure testing. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0016] Figure 1 This is a schematic diagram of an integrated fixing and pressure application device used for amniotic membrane bulging pressure testing in some embodiments of Example 1. Figure 2 This is a front view of an integrated fixing and pressure application device used for amniotic blister pressure and force testing in some embodiments of Example 1; Figure 3 This is a cross-sectional view of the restraint and tension sections before amnion clamping in some embodiments of Example 1; Figure 4 This is a cross-sectional view of the restraint and tension sections after the amnion is clamped, as shown in some embodiments of Example 1. Figure 5 This is a top view of the first constraint member in some embodiments of Example 1; Figure 6 This is a top view of the second constraint and the housing in some embodiments of Example 1.

[0017] In the figure: 1-Constraint part; 11-Test hole; 12-First constraint member; 13-Second constraint member; 14-Sealing part; 141-Annular protrusion; 142-Annular groove; 15-Fastener; 2-Tension part; 21-Hollow cavity; 22-Shell; 221-Fluid port; 3-Support frame. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] The purpose of this invention is to provide an integrated fixing and pressure application device for amniotic membrane bulging pressure testing, so as to solve the problems existing in the prior art and improve the reliability of amniotic membrane mechanical test results and the applicability of mechanical testing devices.

[0020] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0021] Example 1 This embodiment provides an integrated fixation and pressure application device for amniotic bulge pressure stress testing, referencing... Figures 1-6 The device includes a restraint part 1 and a tension part 2. The restraint part 1 has a test hole 11, which is used to cover the amnion and close it through the amnion. The restraint part 1 is used to clamp and fix the amnion at the circumferential edge of the test hole 11. The tension part 2 is connected to the restraint part 1 and has a hollow chamber 21 with an end opening. When the test hole 11 is covered by the amnion, the amnion can close the end opening of the hollow chamber 21. Fluid can be filled into the hollow chamber 21 to apply tension to the amnion. The amniotic membrane is clamped and fixed at the circumferential edge of the test hole 11 by the constraint part 1. The amniotic membrane covers and seals the test hole 11 and the top opening of the tension part 2. When the amniotic membrane at the test hole 11 is subjected to mechanical testing, the constraint part 1 can provide stable and uniform edge constraint for the amniotic membrane, thereby improving the reliability of the test results. Moreover, through the connection between the tension part 2 and the constraint part 1, when the test hole 11 is covered by the amniotic membrane, the amniotic membrane can seal the end opening of the hollow cavity 21. By filling the hollow cavity 21 with fluid, the amniotic membrane is made to generate tension. By changing the fluid pressure in the hollow cavity 21, the tension of the amniotic membrane can be precisely and repeatably adjusted, which meets the prerequisites for comparable mechanical tests such as creep and stress relaxation, and improves the applicability of the integrated fixing and pressurizing device for amniotic membrane blistering pressure stress testing.

[0022] In some embodiments, the constraint part 1 includes a first constraint member 12 and a second constraint member 13 that are detachably connected. Both the first constraint member 12 and the second constraint member 13 have at least partially mating planes. Test holes 11 are formed on the mating planes of the first constraint member 12 and the second constraint member 13, and on the mating planes of the second constraint member 13 and the first constraint member 12. The test holes 11 on the first constraint member 12 and the test holes 11 on the second constraint member 13 are aligned with each other. The amniotic membrane is clamped and fixed at the circumferential edge of the test hole 11 by the mating planes of the first constraint member 12 and the second constraint member 13. The mating planes can provide stable and uniform edge constraints for the amniotic membrane, avoiding local stress concentration in the amniotic membrane and affecting the reliability of the test results.

[0023] In some embodiments, the tension unit 2 includes a housing 22, inside which a hollow cavity 21 is formed. One end of the housing 22 is open, and the edge of the open end of the housing 22 is fixedly connected to the second constraint member 13. The opening of the housing 22 is aligned with the test hole 11 opened on the second constraint member 13. A fluid port 221 is also provided on the side wall of the hollow cavity 21. The fluid port 221 is used to fill or drain the fluid in the hollow cavity 21, thereby changing the fluid pressure in the hollow cavity 21 and realizing precise and repeatable adjustment of the amniotic membrane tension, which meets the prerequisites for comparable mechanical tests such as creep and stress relaxation.

[0024] In some embodiments, the housing 22 is hemispherical, and the fluid port 221 is opened on the side wall of the hollow cavity 21 away from the opening end. When fluid is filled into the hollow cavity 21 through the fluid port 221, the fluid is fully dispersed in the hollow cavity 21 to provide uniform pressure for the amnion located at the test hole 11, so that the amnion generates uniform tension.

[0025] It should be noted that the hemispherical shell 22 is used to simulate the physiological curvature of organs in the human body, such as the uterus. By filling the shell 22 with liquid fluid, the fluid environment inside the human body is simulated, thereby simulating the mechanical properties of the amnion in the organ under the fluid environment.

[0026] In some embodiments, the housing 22 is cylindrical, and the fluid is opened on the end wall of the hollow chamber 21 away from the opening end. When fluid is filled into the hollow chamber 21 through the fluid port 221, the fluid is fully dispersed in the hollow chamber 21 to provide uniform pressure to the amnion located at the test hole 11, so that the amnion generates uniform tension.

[0027] In some embodiments, an exhaust port is provided on the side wall of the hollow chamber 21. During the process of filling the hollow chamber 21 with liquid fluid, the fluid is vented through the exhaust port to ensure that the liquid fluid fills the hollow chamber 21, thereby providing uniform pressure to the amnion located at the test hole 11. In some embodiments, a valve is provided at the exhaust port. After the gas in the hollow chamber 21 is discharged, the valve is closed in time to prevent the liquid fluid in the hollow chamber 21 from overflowing. It should be noted that regardless of whether the fluid port 221 is located at the top or bottom of the hollow chamber 21, the exhaust port should be located at the top of the hollow chamber 21 to prevent the liquid fluid from overflowing from the exhaust port.

[0028] In some embodiments, an annular sealing portion 14 is provided between the first constraint member 12 and the second constraint member 13. The sealing portion 14 is coaxial with the test hole 11. The sealing portion 14 can seal the gap between the first constraint member 12 and the second constraint member 13 located at the circumferential edge of the test hole 11, thereby preventing the fluid in the hollow chamber 21 from overflowing along the gap and improving the stability of the integrated fixing and pressurizing device used for amniotic membrane blistering pressure test.

[0029] In some embodiments, the sealing part 14 includes an annular protrusion 141 fixedly disposed on the first constraint member 12 and an annular groove 142 fixedly disposed on the second constraint member 13. When the first constraint member 12 and the second constraint member 13 are connected, the annular protrusion 141 is embedded in the annular groove 142 to block the overflow channel of the fluid in the hollow cavity 21 and prevent the fluid in the hollow cavity 21 from overflowing along the gap.

[0030] In some embodiments, a water-swellable sealing material is provided in the annular groove 142. When the liquid fluid in the hollow cavity 21 overflows through the gap between the first constraint member 12 and the second constraint member 13 located at the circumferential edge of the test hole 11 under the pressure inside the hollow cavity 21, the water-swellable sealing material expands, further improving the sealing performance of the sealing part 14 and blocking the overflow channel of the fluid in the hollow cavity 21.

[0031] In some embodiments, the integrated fixing and pressurizing device for amniotic membrane blistering pressure testing further includes a support frame 3. The end of the support frame 3 is fixedly connected to the second constraint member 13, and the tension part 2 is disposed inside the support frame 3. When conducting mechanical testing on the amniotic membrane, the support frame 3 can be placed on a test bench, with the second constraint member 13 located at the top of the support frame 3, the first constraint member 12 located at the top of the second constraint member 13, and the amniotic membrane located between the first constraint member 12 and the second constraint member 13, disposed inside the support frame 3. A fluid port 221 opened on the housing 22 is located at the bottom of the housing 22, and a pipeline is connected to the fluid port 221 to introduce fluid into the hollow cavity 21 or to discharge fluid from the hollow cavity 21.

[0032] In some embodiments, a pressure control unit is provided on the pipeline connected to the fluid port 221 to control the flow rate and volume of the fluid entering the cavity 21 of the box. Specifically, the pressure control unit includes a pulse pump, which simulates different regular fluid pressure environments by controlling the pressure amplitude, pulse frequency, and waveform of the fluid entering the box. For example, when the amniotic membrane is used, it can simulate fluid pressure changes under uterine contractions or other physiological or physical conditions. In some embodiments, the integrated fixation and pressure application device for amniotic bulging pressure testing also includes a force sensor. The probe of the force sensor is distributed in the area of ​​the amniotic membrane located within the test hole 11 to collect data such as the deformation and tension changes of the amniotic membrane, and then analyze the mechanical properties of the amniotic membrane, such as stress-strain relationship, compressive strength, and elastic recovery ability.

[0033] In some embodiments, the edges of the first constraint member 12 and the second constraint member 13 are fixed by multiple points of fastener 15, so that the planes of the first constraint member 12 and the second constraint member 13 that are in contact with each other can be pressed together, thereby providing stable and uniform edge constraint on the amniotic membrane disposed between the first constraint member 12 and the second constraint member 13, and avoiding local stress concentration in the amniotic membrane. In some embodiments, the first constraint member 12 and the second constraint member 13 are both plate-shaped members of the same size, and the fasteners 15 are evenly distributed along the edges of the first constraint member 12 and the second constraint member 13. In some embodiments, the fasteners 15 include graduated torque bolts, and by tightening the torque bolts evenly distributed along the edges of the first constraint member 12 and the second constraint member 13 to the same torque value, the uniformity of the constraint force on the edge of the amniotic membrane is improved.

[0034] In some embodiments, the integrated fixation and pressure application device for amniotic bulging pressure testing includes multiple hemispherical shells 22 with different diameters. During the experiment, a specific hemispherical shell 22 can be selected and connected to the constraint part 1 to simulate the curvature of different physiological structures and adapt to mechanical testing of different types of amniotic membrane samples. In some embodiments, the shell 22 and the second constraint member 13 are integrally formed. During the experiment, the amniotic membrane is placed between the first constraint member 12 and the second constraint member 13, and the second constraint member 13 is connected and fixed to the first constraint member 12 by fasteners 15, which improves the convenience of the experiment.

[0035] Example 2 This embodiment provides a method for testing the mechanics of the amniotic membrane, which uses the integrated fixing and pressure-applying device for testing the pressure and force of the amniotic membrane bulging as described in Embodiment 1, and includes the following steps; The amniotic membrane is clamped and fixed at the circumferential edge of the test hole 11 by the constraint part 1. The amniotic membrane covers and seals the test hole 11 and the top opening of the tension part 2. Specifically, the support frame 3 is placed on the test table, and the second constraint member 13 is located at the top of the support frame 3. The amniotic membrane to be tested is placed on the top surface of the second constraint member 13 and covers the test hole 11 of the second constraint member 13. Then, the first constraint member 12 is placed on the top surface of the second constraint member 13, and the test holes 11 of the first constraint member 12 and the second constraint member 13 are aligned. The annular protrusion 141 is embedded in the annular groove 142 to seal the gap between the first constraint member 12 and the second constraint member 13 at the circumferential edge of the test hole 11. Then, the first constraint member 12 and the second constraint member 13 are connected and fixed by the fastener 15, thereby clamping and fixing the amniotic membrane at the circumferential edge of the test hole 11, providing stable and uniform edge constraint for the amniotic membrane, thereby improving the reliability of the test results.

[0036] Fluid is introduced into the hollow chamber 21 of the tension section 2 to apply tension to the amnion. Specifically, the pulse pump on the pipe connected to the water inlet is turned on. The pressure amplitude, pulse frequency and waveform of the fluid introduced into the hollow chamber 21 are controlled by the pulse pump to simulate different regular fluid pressure environments. Through the probes of the force sensors distributed in the area of ​​the amnion located in the test hole 11, data such as the deformation and tension changes of the amnion are collected. Then, the stress-strain relationship, compressive strength and elastic recovery ability of the amnion are analyzed. The amnion tension can be accurately and repeatably adjusted, which meets the prerequisites for comparable mechanical tests such as creep and stress relaxation. This improves the applicability of the integrated fixing and pressurizing device for amnion blistering pressure test.

[0037] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. An integrated fixing and pressure application device for testing the pressure and stress of amniotic bulges, characterized in that: The device includes a restraint section and a tension section. The restraint section has a test hole for covering and closing the amnion. The restraint section is used to clamp and fix the amnion at the circumferential edge of the test hole. The tension section is connected to the restraint section and has a hollow chamber with an end opening. When the test hole is covered by the amnion, the amnion can close the end opening of the hollow chamber. Fluid can be filled into the hollow chamber to apply tension to the amnion.

2. The integrated fixing and pressure application device for amniotic blister pressure testing according to claim 1, characterized in that: The constraint part includes a first constraint member and a second constraint member that are detachably connected. Both the first constraint member and the second constraint member have at least partially flat surfaces that can fit together. The test hole is opened on the flat surface on which the first constraint member and the second constraint member fit together, and on the flat surface on which the second constraint member and the first constraint member fit together. The test hole opened on the first constraint member and the test hole opened on the second constraint member are aligned with each other.

3. The integrated fixing and pressure application device for amniotic blistering pressure testing according to claim 2, characterized in that: The tensioning part includes a housing with a hollow cavity inside. One end of the housing is open, and the edge of the open end of the housing is fixedly connected to the second constraint member. The opening of the housing is aligned with the test hole opened on the second constraint member. A fluid port is also provided on the side wall of the hollow cavity for filling or discharging fluid into or out of the hollow cavity.

4. The integrated fixing and pressure application device for amniotic membrane bulging pressure testing according to claim 3, characterized in that: The shell is hemispherical, and the fluid port is located on the side wall of the hollow chamber away from the opening end.

5. The integrated fixing and pressure application device for amniotic blistering pressure testing according to claim 3 or 4, characterized in that: An exhaust port is also provided on the side wall of the hollow chamber.

6. The integrated fixing and pressure application device for amniotic bulging pressure testing according to claim 2, characterized in that: An annular sealing portion is provided between the first constraint member and the second constraint member. The sealing portion is coaxial with the test hole and can seal the gap between the planes of the first constraint member and the second constraint member that are located at the circumferential edges of the test hole.

7. The integrated fixing and pressure application device for amniotic blistering pressure testing according to claim 6, characterized in that: The sealing part includes an annular protrusion fixedly disposed on the first constraint member and an annular groove fixedly disposed on the second constraint member. When the first constraint member and the second constraint member are connected, the annular protrusion is embedded in the annular groove.

8. The integrated fixing and pressure application device for amniotic blistering pressure testing according to claim 7, characterized in that: A water-swellable sealing material is provided inside the annular groove.

9. The integrated fixing and pressure application device for amniotic blistering pressure testing according to claim 2 or 4, characterized in that: The integrated fixing and pressure device for amniotic bulging pressure testing further includes a support frame, the end of which is fixedly connected to the second constraint member, and the tension part is disposed inside the support frame.

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