Protein yarn gel composite tube material and preparation method thereof

Abstract

The invention relates to the technical field of medical instrument testing, in particular to a protein yarn gel composite tube material and a preparation method thereof.According to the design of the protein yarn gel composite tube material, the structural characteristics of real blood vessels are fully considered, and a protein woven tubular structure is adopted as a blood vessel frame to simulate the elasticity and pressure resistance of blood vessel walls; a gelatin-egg white solution is adopted to form a gel matrix to wrap and fill a protein braided tube, and the gel matrix serves as intravascular smooth muscle; the ultrasonic knife fatigue test can be carried out by effectively replacing animal tissues, the problem that materials are prone to corrosion can be avoided, and meanwhile more consistent and controllable test conditions can be provided.

Description

Technical Field

[0001] The invention relates to the technical field of medical device testing, and in particular to a protein yarn gel composite tube material and a preparation method thereof. Background Art

[0002] Ultrasonic scalpel, full name ultrasonic soft tissue cutting and hemostasis equipment, is a medical shell surgical device that uses ultrasonic energy to cut and hemostasis soft tissue. It is suitable for application scenarios where soft tissue cutting needs to be controlled with minimal thermal damage. It has the advantages of precision, speed, less bleeding, and fast postoperative recovery. It is increasingly widely used in surgical operations. However, with the widespread use of ultrasonic scalpels, its potential safety hazards are gradually exposed. Especially in clinical applications, the high-frequency vibration frequency of ultrasonic scalpels can reach 55.5kHz, and the number of vibrations in half an hour is close to 1×10^8 times, but too high a vibration frequency will inevitably cause fatigue damage to the material, resulting in a decrease in the surgical efficiency of the ultrasonic scalpel head, and even medical accidents such as scalpel head breakage.

[0003] Since the high-frequency mechanical vibration of the ultrasonic scalpel tip is directly related to the success or failure of the operation and the life safety of the patient, its reliability is crucial. However, in the narrow surgical space, it is difficult to configure monitoring or redundant backup equipment to improve its reliability. Therefore, it is particularly important to conduct fatigue tests on ultrasonic scalpels. This test helps evaluate the durability and reliability of ultrasonic scalpels after long-term use and is a key link in product quality control. By conducting rigorous fatigue tests on ultrasonic scalpels, it can not only ensure that its performance in surgery will not be reduced due to long-term use, but also timely discover and improve potential defects, and improve the safety and effectiveness of surgery. In addition, this test can also help manufacturers extend product life, reduce surgical costs, and enhance product competitiveness. Therefore, fatigue testing of ultrasonic scalpels is a necessary step to ensure their reliable operation and efficient performance in medical minimally invasive surgery. In addition, regular fatigue testing is also part of the certification process of regulatory agencies, which helps to ensure that ultrasonic scalpels meet the strict standards and regulations of the medical industry.

[0004] At present, the commonly used material for ultrasonic scalpel fatigue test is animal tissue. Although this material is common, it has multiple disadvantages:

[0005] 1. The use of animal tissues places high demands on the timeliness of experiments. Animal tissues will rot, and their biological properties change rapidly over time, so they cannot be preserved for a long time.

[0006] 2. Animal testing is also limited by sample size and individual biological differences, which affects the scale of the experiment and the consistency of the results.

[0007] 3. The biological differences between animals and humans may cause the test results to be incompletely applicable to humans, reducing the reliability and universality of the test.

[0008] 4. This method involves ethical controversy because it requires sacrificing animals to obtain tissues, which conflicts with the moral concepts of many people.

[0009] 5. Animal testing is costly, involving specialized equipment, animal care and ethical experimental conditions, which not only increases the economic burden but also prolongs the time it takes for a product to go from development to market.

[0010] Therefore, developing a new, stable, low-cost and easily accessible experimental material can not only avoid the above problems, but also improve the efficiency and reliability of the test, and be more in line with ethical and scientific requirements. At the same time, it will also bring new development prospects for the fatigue test of ultrasonic scalpels and the development of future medical tools. Summary of the invention

[0011] In view of this, the present invention proposes a protein yarn gel composite tube material and a preparation method thereof, the design of which fully considers the structural characteristics of real blood vessels, adopts a protein woven tubular structure as a vascular frame to imitate the elasticity and compressive resistance of the vascular wall; a gelatin-egg white solution is used to form a gel matrix to wrap and fill the protein woven tube, acting as the smooth muscle in the blood vessel; it can not only effectively replace animal tissue for ultrasonic knife fatigue testing, but also avoid the problem of material perishability, while providing more consistent and controllable test conditions.

[0012] The present invention adopts the following technical solution:

[0013] A protein yarn gel composite tube material is used for ultrasonic surgical knife fatigue test, comprising a protein braided tube as a vascular frame, wherein the protein braided tube is woven with protein yarn and wrapped and filled with a gel matrix using a dipping-spinning method to form intravascular smooth muscle, wherein the gel matrix is ​​configured with animal gelatin and egg white solution.

[0014] Furthermore, the protein braided tube has a diameter of 4.5-5.5 mm and a thickness of 1-1.5 mm.

[0015] A method for preparing a protein yarn gel composite tube material comprises the following steps:

[0016] Step 1, double-knitting the protein yarn to make a protein braided tube as a blood vessel frame;

[0017] Step 2, preparing the gel matrix at 40-45° C.;

[0018] 2.1. Place the egg white solution and animal gelatin in a container, and stir to mix them evenly until they are completely blended to obtain a first mixture; the mass ratio of the egg white solution to the animal gelatin is 1:2 to 1:3;

[0019] 2.2, adding a cross-linking agent to the first mixture and continuing to stir to obtain a gel matrix solution;

[0020] There is no order of precedence between step 1 and step 2;

[0021] Step 3: Use the immersion-rotation method to uniformly wrap the gel matrix on the protein tube, thereby preparing a protein yarn gel composite tube for ultrasonic scalpel fatigue test.

[0022] Furthermore, the step of preparing the gel matrix at 40-45° C. further includes a step of pretreating the animal gelatin before preparing the first mixture, including:

[0023] Soak the animal gelatin powder in cold water for 5 to 10 minutes to allow it to fully absorb water and swell; the mass ratio of animal gelatin powder to water is 1:1.5 to 1:2.

[0024] Furthermore, the protein yarn in step 1 has a specification of 260D216F and a type of DTY filament.

[0025] Furthermore, the protein concentration in the egg white solution in step 2.1 is 0.1 g / mL, the cross-linking agent in step 2.2 is potassium phosphate, and the concentration of potassium phosphate in the final gel matrix solution is 0.05-0.1 g / mL.

[0026] Furthermore, the stirring conditions in step 2.1 are: stirring speed of 3 to 5 r / s, and total stirring time of 15 to 20 min; the stirring conditions for continued stirring in step 2.2 are: stirring speed of 3 to 5 r / s, and stirring time of 8 to 12 min.

[0027] Further, the method of uniformly wrapping the gel matrix on the protein tube using the immersion-rotation method comprises the following steps:

[0028] 3.1. Soak the protein braided tube in the gel matrix solution prepared in step 2 for 3 to 5 minutes, then take it out and place it on a centrifuge;

[0029] 3.2. Use a rotating centrifugal method to make the gel matrix solution evenly adhere to the surface of the protein braided tube, the centrifugal speed is 1000-2000RPM, and the time is 10-15min;

[0030] 3.3. Wait for 20 to 30 minutes for the gel matrix to solidify and remove the protein compound tube from the centrifuge.

[0031] Furthermore, the method for preparing the above protein yarn gel composite tube material further includes step 4 of performing subsequent steps on the protein composite tube, including:

[0032] The protein yarn gel composite tube is cut, trimmed, washed and sterilized in sequence according to needs, and then placed in a dry environment for refrigeration for fatigue testing of ultrasonic scalpels; the refrigeration temperature is 2°C to 8°C.

[0033] The most important function of an ultrasonic scalpel is its coagulation effect on blood vessels. The principle is as follows: when the vibrating blade of an ultrasonic scalpel contacts a blood vessel, the high-frequency vibration causes the blade and human tissue to move relative to each other at an extremely high speed, generating shear force, which directly physically cuts the blood vessel and separates it, thereby achieving the function of cutting off the blood vessel. At the same time, due to the friction between tissues caused by ultrasonic vibration, heat is generated, which denatures the proteins (such as collagen and elastin) in the vascular tissue and changes its structure. In the vascular tissue, this thermal effect causes the proteins to coagulate and form solid blockages. The damaged parts of the vascular wall are sealed by these coagulated proteins, forming a natural "seal" that prevents blood from flowing out, thereby achieving the coagulation function of the blood vessel.

[0034] The protein yarn gel composite tube material provided by the present invention fully considers the structural characteristics of real blood vessels, wherein the protein braided tube provides structural support, mimics the elasticity and compression resistance of the blood vessel wall, and the gel matrix formed by gelatin and egg white provides elasticity and density similar to the smooth muscle in the blood vessel. That is, the main components of the protein yarn, animal gelatin and egg white solution used in the construction of the material are also proteins, so the most important function of the ultrasonic scalpel can be fatigue tested to test the ability of the ultrasonic scalpel to coagulate blood vessels.

[0035] The protein yarn gel composite tube material provided by the present invention has the following advantages compared with the animal tissue material test of transmission:

[0036] 1. Good stability and long-term storage: Traditional animal tissues are perishable and need to be stored under specific low temperature conditions, and their service life is relatively short; not only does it increase the maintenance cost of test materials, but there is also the problem of test materials deteriorating due to improper storage, affecting the reliability of experimental results. In contrast, protein yarn gel composite tube materials have better chemical and biological stability, avoid rapid corruption and complex storage requirements, and can be stored for a long time under relatively simple refrigeration conditions, significantly reducing the difficulty and cost of maintenance and storage.

[0037] 2. Consistency and repeatability: Due to the influence of genetic and environmental factors, animal tissues may have significant differences between each sample, while the protein yarn gel composite tube material of the present invention is a man-made material, which can ensure the consistency and repeatability of each experiment and improve the accuracy of the test results.

[0038] 3. Reduce costs: Animal testing involves multiple costs such as the purchase, breeding, handling and disposal of animals, while synthetic materials have relatively low production costs and are easy to mass produce and store, reducing overall testing costs.

[0039] 4. Convenient for large-scale and standardized testing: The specifications and dimensions of the present invention are controllable, which is convenient for large-scale standardized testing and very convenient for multiple tests of ultrasonic scalpel fatigue tests.

[0040] 5. Close to human tissue conditions: The present invention takes into account the structure and physical properties of real human blood vessels, such as elasticity, density and cutting response, and uses a protein braided tubular structure as a blood vessel frame, so that it can imitate the elasticity and compression resistance of the blood vessel wall; gelatin-egg white solution is used to form a gel matrix to wrap and fill the protein braided tube, so that it can act as smooth muscle in the blood vessel. Therefore, it can more accurately reflect the performance of the ultrasonic scalpel under actual medical conditions.

[0041] 6. Ethics: The use of simulated materials can avoid the use of live animals for experiments, reduce animal pain and sacrifice, and comply with modern scientific research ethical standards.

[0042] 7. Avoid biosafety risks: Animal tissues may carry pathogens, but the use of artificial materials does not have this risk, thus improving the biosafety of the experiment.

[0043] 8. Material properties can be flexibly adjusted: The protein yarn gel composite tube material of the present invention can be cut, trimmed, washed and sterilized as needed to adapt to different test requirements and characteristics of surgical tools, providing a wider range of application possibilities.

[0044] In summary, the protein yarn gel composite tube material of the present invention provides unparalleled advantages over traditional animal testing methods in terms of cost, ease of acquisition, operation, ethics and science, and has positive significance for ultrasonic scalpel fatigue testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 This is a schematic diagram of the structure of the protein yarn gel composite tube material;

[0046] Figure 2 This is a spectrum comparison diagram of protein yarn gel composite tube material and animal blood vessels;

[0047] Figure 3 This is a comparison chart of the instantaneous frequency of the protein yarn gel composite tube material and the animal blood vessel cutting state;

[0048] Reference numerals:

[0049] 1 is a protein yarn braided tube, 2 is a gel matrix. DETAILED DESCRIPTION

[0050] The technical solution of the present invention is described in detail below in conjunction with the accompanying drawings and embodiments.

[0051] See also Figure 1 The present embodiment provides a protein yarn gel composite tube material, including a protein braided tube 1 as a vascular frame, the protein braided tube is woven with protein yarn, and is used to simulate the collagen fiber and elastic fiber structure in a real blood vessel. The gel matrix 2 is wrapped and filled using a dip-rotation method to form intravascular smooth muscle, and the gel matrix is ​​configured with animal gelatin and egg white solution to simulate the smooth muscle in a real blood vessel.

[0052] Experimental verification:

[0053] In this embodiment, a protein yarn gel composite tube material sample was prepared according to the aforementioned protein yarn gel composite tube material preparation method, and a laser vibrometer was used to conduct comparative tests on the protein yarn gel composite tube and animal blood vessels to verify the feasibility of using the protein yarn gel composite tube to replace animal blood vessels as the test material for the ultrasonic knife fatigue test.

[0054] The laser vibrometer was used to collect vibration data of the cutting process when the ultrasonic scalpel cut animal blood vessels and protein yarn gel composite tubes, and then the data was analyzed, relevant indicators were extracted and compared. The main function of the ultrasonic scalpel is its cutting and hemostasis and coagulation function of blood vessels, so the similarity between the protein yarn gel composite tube and blood vessels was analyzed and verified based on these two functions:

[0055] Table 1 Records of various indicators collected

[0056]

[0057] As shown in Table 1, the vibration data indicators in the time domain collected by the ultrasonic scalpel when cutting and coagulating the protein yarn gel composite tube and the blood vessel are very close.

[0058] The mean reflects the center position of the data set. The mean values ​​of the protein yarn gel composite tube and the blood vessel are both around 61 microns, indicating that the ultrasonic scalpel encounters similar resistance when cutting the two materials, and the shear modulus of the two materials is similar. Variance is a standard for rapid data volatility. The close variance of the two objects under test indicates that the amplitude fluctuation of the ultrasonic scalpel during the cutting process is almost the same, which again shows that the physical and mechanical properties when resisting the changes in ultrasonic scalpel cutting are similar. Kurtosis reflects the sharpness of the data distribution; the shape factor is used to evaluate the uniformity of the data set or the degree of deviation from the central trend, and can be used to compare the mechanical properties of different materials or structures, especially their response characteristics when subjected to pressure or vibration. The close kurtosis and shape factor indicate that the two materials have similar performance in certain physical properties or structural strength. In summary, when testing the cutting performance of the ultrasonic scalpel, the protein yarn gel composite tube can more realistically replace the blood vessel as the material under test.

[0059] The heat generated by the high-frequency vibration of the ultrasonic knife head causes the protein in the blood vessel wall to denature and coagulate at high temperature, achieving the effect of hemostasis and blood vessel coagulation. The main components of blood vessels, smooth muscle, collagen fiber and elastic fiber are all composed of protein, and the protein yarn and gelatin that make up the protein yarn gel composite tube are also composed of protein. The protein content of the two materials is basically the same. Figure 2 It can be seen that the main frequency of ultrasonic knife cutting protein yarn gel composite tube and blood vessel is around 55600Hz; Figure 3 , Figure 3 The solid line above represents the animal blood vessel, and the dotted line below the solid line represents the protein yarn composite gel tube. Figure 3 It can be seen that the instantaneous frequency change stability of the ultrasonic knife when cutting the two materials is very similar, and both are concentrated in 5500Hz~55600Hz; combined with the data performance of the very close means and variances of the two in Table 1, it shows that the energy concentration degree and the energy generated by the ultrasonic knife when cutting the two materials are basically the same, and the total heat and heat concentration generated to denature the protein are also basically the same. Therefore, when testing the hemostatic and coagulation performance of the ultrasonic knife on blood vessels, the protein yarn gel composite tube material of this embodiment can replace blood vessels as the tested material.

[0060] The above is only used to illustrate the technical solution of the present invention and is not intended to limit it. Other modifications or equivalent substitutions made to the technical solution of the present invention by ordinary technicians in this field should be included in the scope of the claims of the present invention as long as they do not deviate from the spirit and scope of the technical solution of the present invention. This includes but is not limited to adjustments in material composition, detailed preparation process, and the use of different cross-linking agents or additives to optimize material properties. All these changes and improvements should be regarded as part of the scope of the present invention as long as they conform to the basic creative idea of ​​the present invention, that is, simulating real blood vessels to test the fatigue characteristics of ultrasonic surgical knives, and do not affect its core purpose and effect.

Claims

1. A protein yarn gel composite tube material, which is used for ultrasonic scalpel fatigue test. Features: The invention comprises a protein braided tube as a blood vessel frame, wherein the protein braided tube is braided with protein yarn and wrapped and filled with a gel matrix by a dipping-spinning method to form intravascular smooth muscle, wherein the gel matrix is ​​configured with animal gelatin and egg white solution.

2. A protein yarn gel composite tube material according to claim 1, Features: The protein braided tube has a diameter of 4.5-5.5 mm and a thickness of 1-1.5 mm.

3. A method for preparing a protein yarn gel composite tube material, The following steps are involved: Step 1, double-knitting the protein yarn to make a protein braided tube as a blood vessel frame; Step 2, preparing the gel matrix at 40-45° C.; 2.

1. Place the egg white solution and animal gelatin in a container, and stir to mix them evenly until they are completely blended to obtain a first mixture; the mass ratio of the egg white solution to the animal gelatin is 1:2 to 1:3; 2.2, adding a cross-linking agent to the first mixture and continuing to stir to obtain a gel matrix solution; There is no order of precedence between step 1 and step 2; Step 3: Use the immersion-rotation method to uniformly wrap the gel matrix on the protein tube, thereby preparing a protein yarn gel composite tube for ultrasonic scalpel fatigue test.

4. A protein yarn gel composite tube material according to claim 3, It is characterized in that The step of preparing the gel matrix at 40-45° C. further includes a step of pre-treating the animal gelatin before preparing the first mixture, including: Soak the animal gelatin powder in cold water for 5 to 10 minutes to allow it to fully absorb water and swell; the mass ratio of animal gelatin powder to water is 1:1.5 to 1:

2.

5. A protein yarn gel composite tube material according to claim 3, It is characterized in that The protein yarn in step 1 has a specification of 260D216F and a type of DTY filament.

6. A protein yarn gel composite tube material according to claim 3, Features: The protein concentration in the egg white solution in step 2.1 is 0.1 g / mL, the cross-linking agent in step 2.2 is potassium phosphate, and the concentration of potassium phosphate in the final gel matrix solution is 0.05-0.1 g / mL.

7. A protein yarn gel composite tube material according to claim 3, Features: The stirring conditions in step 2.1 are: a stirring speed of 3 to 5 r / s and a total stirring time of 15 to 20 min; the stirring conditions for continued stirring in step 2.2 are: a stirring speed of 3 to 5 r / s and a stirring time of 8 to 12 min.

8. A protein yarn gel composite tube material according to claim 3, It is characterized in that A method for uniformly wrapping a gel matrix on a protein tube using a dip-rotation method, the steps comprising: 3.

1. Soak the protein braided tube in the gel matrix solution prepared in step 2 for 3 to 5 minutes, then take it out and place it on a centrifuge; 3.

2. Use a rotating centrifugal method to make the gel matrix solution evenly adhere to the surface of the protein braided tube, the centrifugal speed is 1000-2000RPM, and the time is 10-15min; 3.

3. Wait for 20 to 30 minutes for the gel matrix to solidify and remove the protein compound tube from the centrifuge.

9. A protein yarn gel composite tube material according to claim 3, Features: The method for preparing the protein yarn gel composite tube material further includes step 4 of performing subsequent steps on the protein composite tube, including: The protein yarn gel composite tube is cut, trimmed, washed and sterilized in sequence according to needs, and then placed in a dry environment for refrigeration for fatigue testing of ultrasonic scalpels; the refrigeration temperature is 2°C to 8°C.

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