Easily cut low-divergence medical elastic thread

Abstract

The application belongs to the technical field of medical elastic thread, and particularly relates to an easy-to-cut low-dispersion medical elastic thread. The medical elastic thread comprises an outer layer and an inner layer. The outer layer is a wrapping thread. The inner layer comprises one or more inner cores. The wrapping thread is polyester fiber knitting, or polyester fiber and polyethylene fiber mixed knitting, or polyester fiber and polylactic acid fiber mixed knitting. The inner core is a silica gel thread knitting. The main feature of the easy-to-cut low-dispersion medical elastic thread is that the friction is large, the anchoring performance is good, the elastic thread is not easy to slip off, the elastic thread is easier to cut, and the diameter of the broken end after cutting is smaller.

Description

Technical Field

[0001] This invention belongs to the field of medical elastic thread technology, and particularly relates to a medical elastic thread that is easy to cut and has low divergence. Background Technology

[0002] Medical elastic sutures are medical materials used in various ligation surgeries and for temporary ligation and fixation of external tubes. Their application scenarios place certain requirements on their biological and physical properties. Firstly, they must have good biocompatibility to avoid irritating biological tissues and ensure postoperative recovery. Secondly, they must have sufficient physical properties and operability. During surgery, to reduce the total amount of residual material in the tissue, the diameter and size of the elastic sutures used are very small. To ensure stable retention and maintenance of their physical properties after surgery, they must have sufficient strength and toughness. Therefore, the applicant has specifically developed a medical elastic suture (CN 202210266804.0) tailored to the characteristics of medical scenarios. It has good biocompatibility indicators and low sliding resistance at the knot position, facilitating ligation surgery. After a period of application and verification, it can meet the medical needs of medical scenarios such as banding surgery. However, during the application process, customers reported that there is a problem that the elastic thread is difficult to cut after banding. In some cases, it is necessary to cut it two or even more times before the elastic thread can be successfully cut. On the one hand, it affects the progress of the operation, and on the other hand, it causes large fringe edges after the cut end. Therefore, it is necessary to conduct research and development to improve it. Summary of the Invention

[0003] The purpose of this invention is to provide a medical elastic thread with better performance, less prone to slippage, easy to cut and low divergence.

[0004] To achieve the above objectives, the present invention adopts the following technical solution.

[0005] A medical elastic thread with easy shearing and low divergence includes an outer layer and an inner layer. The outer layer is a wrapping thread, and the inner layer includes one or more inner cores. The wrapping thread is a polyester fiber braid, or a mixed braid of polyester fiber and polyethylene fiber, or a mixed braid of polyester fiber and polylactic acid fiber; the inner core is a silicone wire braid.

[0006] As a further definition or preferred embodiment of the aforementioned easily shearable and low-diffusion medical elastic thread, the wrapping thread is a woven fabric composed of 40% to 80% polyester fiber and 20% to 60% polyethylene fiber.

[0007] As a further definition or preferred embodiment of the aforementioned easily shearable and low-diffusion medical elastic thread, the wrapping thread is a mixed woven fabric of 20% to 80% polyester fiber and 20% to 80% polyethylene fiber.

[0008] As a further definition or preferred embodiment of the aforementioned easily shearable and low-diffusion medical elastic thread, the burr diameter of the medical elastic thread is 1.9 to 3.8 mm.

[0009] As a further definition or preferred embodiment of the aforementioned easily shearable and low-divergence medical elastic thread, the medical elastic thread is used in anorectal ligation devices.

[0010] As a further definition or preferred embodiment of the aforementioned easily shearable and low-divergence medical elastic thread, the medical elastic thread is used for temporary ligation and fixation of internal and external tubing in biological systems.

[0011] As a further definition or preferred embodiment of the aforementioned easily shearable and low-divergence medical elastic thread, the internal and external conduits refer to tissue channels, including blood vessels and trachea.

[0012] As a further definition or preferred embodiment of the aforementioned easily shearable and low-divergence medical elastic thread, the stretch ratio of the medical elastic thread is 1.6 to 2.0.

[0013] As a further definition or preferred option for the aforementioned easily sheared and low-diffusion medical elastic yarn, polyester fibers are produced and processed using the following grades of raw materials: FE19051, BK507, BG801, VG30, VGH30, PGE-30, WB-8828AA, WB-8828B, WB-8839AA, WB-8863AA, CZ-302, 80-K, 80-T, QR3000GFR30, FR530, CB-602, CB-606, CB-608S, SE-5030, SE-3030, CB608, CB608S, CB651, TH102C, TH105, G20S, G30S, NP-12, NP-13, NP-22, BG80, and BG85.

[0014] Its beneficial effects are as follows:

[0015] The main features of the easily shearable and low-divergence medical elastic thread provided by this invention compared with existing products are that it has high friction and good adhesion, making it less prone to slippage. At the same time, the elastic thread is easier to cut and the diameter of the broken end is smaller after cutting. Attached Figure Description

[0016] Figure 1 It is a schematic diagram of a knot used to simulate the state of the corresponding knot during banding;

[0017] Figure 2 This is a schematic diagram showing the inner core being extruded and exposed during the fracture test;

[0018] Figure 3 This is a diagram showing the broken ends of the No. 3 elastic thread control group after it was cut.

[0019] Figure 4 This is a diagram showing the broken ends of the No. 1 elastic cord control group after it was cut.

[0020] Figure 5 This is a diagram showing the broken end of the elastic cord after it was cut in the No. 2 elastic cord experimental group;

[0021] Figure 6 This is a schematic diagram of the broken end after the No. 7 elastic cord was cut in the experiment. Detailed Implementation

[0022] The following analysis and explanation of the medical elastic cord of the present invention are based on specific embodiments and sample tests.

[0023] For ease of understanding, this application establishes a control group based on existing product solutions and provides an experimental group based on the technical solution of this application for control experiments.

[0024] The control group consisted of a product derived from the technical solution described in medical elastic cord (CN 202210266804.0). This elastic cord's outer layer is wrapped with high-density polyethylene fiber / polylactic acid fiber, and its inner layer consists of silicone filaments, polycarbonate-based polyurethane, thermoplastic elastomer, and thermoplastic polyurethane rubber. During testing, the inner core material primarily provides fixation and support, and its material has minimal impact on the overall performance of the elastic cord. For ease of testing and considering practical considerations, both the experimental and control groups used silicone filaments for their inner cores. The elastic cord's weaving scheme adopted the scheme described in medical elastic cord (CN 202210266804.0).

[0025] Six series of samples were formed by combining different component schemes to serve as control groups. At the same time, six series of samples were also obtained by combining according to the technical solution of the present invention to serve as experimental groups. The composition of the wrapping line in each group is shown in Table 1:

[0026] Table 1 Parameters of Elastic Line

[0027]

[0028]

[0029] Based on the aforementioned tests conducted on the control and experimental groups, and according to the actual application requirements of medical elastic threads, the following parameters were measured:

[0030] 1. The tensile force required for the elastic cord to break is used to ensure that the elastic cord does not break during the stretching process. According to experimental tests, its breaking force should not be less than 60-75N (based on the elastic cord binding gun with automatic cord breaking function designed by invention patent CN202111107984.X as a reference test); the maximum tensile force value when the elastic cord breaks is recorded using a tensile testing machine (e.g., Figure 2 (as shown);

[0031] 2. Friction force value: Based on user feedback, the elastic cord is difficult to cut and has a low probability of slipping after cutting. The main reason is insufficient surface friction of the elastic cord. Therefore, it is necessary to test its friction force index; the test simulates the corresponding knot state after bandaging (e.g., Figure 1 (As shown), record the minimum tension value that causes the knot to move;

[0032] 3. Elongation ratio value: To ensure that the elastic thread has sufficient toughness during use and can meet the requirements of tying operations without breaking, it is necessary to test the elongation ratio; the test uses 100mm elastic thread and records the maximum elongation ratio.

[0033] 4. The diameter of the elastic cord after cutting, that is, the final diameter of the elastic cord after it is cut and shrinks. If the size is too small, it indicates that its toughness is poor and its adaptability to the shape changes during the tissue recovery period is reduced.

[0034] 5. The diameter of the burr after cutting, that is, the diameter of the burr at the end after the elastic thread is cut. The larger the diameter, the more and longer the thread ends, which is more irritating to biological tissues and more likely to leave foreign objects during use.

[0035] The corresponding test results are shown in Table 2:

[0036] Table 2. Test results of elastic wire

[0037]

[0038]

[0039] In other cases besides the aforementioned test data: such as Figure 2 As shown, during the fracture test, the materials in all groups within the control group, as well as experimental groups 10 and 11, experienced core extrusion and exposure within the non-fracture region (see...). Figure 2 The white particles were found to be caused by a mismatch in the dimensional changes of the outer layer and the inner core after stretching, resulting in a rapid decrease in the size of the outer layer material after stretching. This situation was not found in experimental groups 7, 8, 9, and 12.

[0040] Based on the comparative analysis in the table above, the experimental group regimens of this application, compared with the control group regimens, have the following conclusions:

[0041] 1. The number of cuts in each experimental group was significantly improved compared with the control group. Among them, the 7th, 8th and 12th experimental groups were able to achieve one cut without the need for a second cut, which enabled better surgical operation.

[0042] 2. The breaking force and tensile ratio of the materials in both the experimental and control groups can meet the requirements for the use of elastic sutures in ligation surgery (based on the elastic suture ligation gun with automatic suture breaking function designed according to invention patent CN202111107984.X as a reference test); among them, the tensile ratio parameters of the materials in each group of the experimental group are better than those in each group of the control group, and have better postoperative maintenance and adaptability. The breaking force of each group of the experimental group is slightly less than that of each group of the control group, but all of them far exceed the breaking force requirements of elastic sutures for surgical application.

[0043] 3. The average friction parameters of each group in the experimental group were better than those in the control group. Compared with the control group, the materials in the experimental group were able to be better fixed and maintained after ligation, and the probability of loosening and slippage was lower; among them, the average friction of materials No. 8, 9, 10 and 11 was better than that of other groups.

[0044] 4. The diameter of the elastic cord in each experimental group after cutting was generally larger than that in the control group, but the diameter of the burr at the cut end was smaller in all groups than in the control group (e.g., Figure 3 , Figure 4 As shown in the figure, this indicates that the experimental groups have a better ability to adapt to tissue deformation and growth after surgery. Among them, the diameter of the cut ends of the experimental groups 7 and 8 was only 50% or even smaller than that of the control groups (as shown in the figure). Figure 5 , Figure 6 As shown in the figure, it can effectively make the elastic line more stable after cutting, with smaller edge size, so that medical staff can better confirm and maintain the elastic line shape before and after cutting, reduce the impact on surgical operation, improve the stability of the elastic line after surgery, and ensure the effectiveness of the ligation operation.

[0045] 5. Calculation It can be seen that the divergence ratio parameters of the materials in each experimental group are much better than those of the materials in each control group. During use, the materials in the experimental group have better shape retention ability, and the changes in elastic lines and fracture size before and after cutting are smaller and more stable, which is conducive to medical staff to better control and determine the postoperative condition and improve the quality of surgery.

[0046] 6. After further medical testing, in addition to being applicable to various ligation surgeries, it can be used for temporary ligation and fixation of internal and external biological channels, including various blood vessels, trachea and other tissue channels.

[0047] Furthermore, to ensure the performance of the medical materials, and after production verification and further confirmation of the production process, the following grades of raw materials are used in the production and processing of polyester fibers in this application: FE19051, BK507, BG801, VG30, VGH30, PGE-30, WB-8828AA, WB-8828B, WB-8839AA, WB-8863AA, CZ-302, 80-K, 80-T, QR3000GFR30, FR530, CB-602, CB-606, CB-608S, SE-5030, SE-3030, CB608, CB608S, CB651, TH102C, TH105, G20S, G30S, NP-12, NP-13, NP-22, BG80, and BG85.

[0048] It should be noted that the above test data is specific to the small-diameter, small-size medical elastic cords targeted in this application. When the diameter of the elastic cord exceeds 10mm, approaching that of everyday elastic ropes, its friction and dispersion ratio do not show the same trend as in this application. After testing and analysis, it can be clearly seen that it is mainly affected by the physical and chemical properties and surface area of ​​the material itself. When the diameter exceeds a certain range, the various parameters are greatly affected by the fabrication scheme and external force characteristics. Therefore, the above-mentioned technical solution is currently only effective within the size range of medical elastic cords involved in this application (generally 0.5mm to 2.5mm).

[0049] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A medical elastic thread with easy shearing and low divergence, comprising an outer layer and an inner layer, wherein the outer layer is a wrapping thread and the inner layer comprises one or more inner cores, characterized in that, The wrapping thread is a blend of 40%~80% polyester fiber and 20%~60% polyethylene fiber, or a blend of 20%~80% polyester fiber and 20%~80% polyethylene fiber, or a blend of 20% polyester fiber and 80% polylactic acid fiber, or a blend of 80% polyester fiber and 20% polylactic acid fiber; the inner core is a silicone filament blend; the diameter of the medical elastic thread is 0.5mm~2.5mm, and the rough edge diameter is 1.9~3.8mm; the tensile ratio of the medical elastic thread is 1.6~2.

0.

2. The easily shearable, low-divergence medical elastic thread according to claim 1, characterized in that, The medical elastic thread is used in anorectal ligation devices.

3. The easily shearable, low-divergence medical elastic thread according to claim 1, characterized in that, The medical elastic thread is used for temporary ligation and fixation of internal and external tubing in biological systems.

4. The easily shearable, low-divergence medical elastic thread according to claim 3, characterized in that, The internal and external conduits refer to tissue channels, including blood vessels and trachea.

5. The easily shearable, low-divergence medical elastic thread according to claim 1, characterized in that, Polyester fibers are produced and processed using the following grades of raw materials: FE19051, BK507, BG801, VG30, VGH30, PGE-30, WB-8828AA, WB-8828B, WB-8839AA, WB-8863AA, CZ-302, 80-K, 80-T, QR3000GFR30, FR530, CB-602, CB-606, CB-608S, SE-5030, SE-3030, CB608, CB608S, CB651, TH102C, TH105, G20S, G30S, NP-12, NP-13, NP-22, BG80, and BG85.

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