Ligation clip pressure resistance testing device and method

Abstract

The invention relates to a ligature clip pressure resistance testing device and method, the ligature clip pressure resistance testing device comprises a butt joint assembly and a testing assembly, the butt joint assembly comprises a butt joint head and a clamping sleeve, and the surface of the butt joint head is provided with a groove along the circumferential direction; the clamping sleeve is arranged on the outer side of the butt joint, a plurality of elastic pieces are arranged on the surface of the clamping sleeve in the circumferential direction, and a notch is formed between any two elastic pieces. The testing assembly comprises a pressure pump, a connecting hose, a testing hose and a tightening rope, one end of the connecting hose is connected with the pressure pump, the other end of the connecting hose is connected with the butt joint, and the testing hose is connected with the end, away from the connecting hose, of the butt joint; the fastening ropes are arranged on the outer side of the clamping sleeve in a sleeving mode. The test hose is used for simulating blood vessels and tissues, and a plurality of tightening ropes can be cached through the butt joint, so that the clamping durability of a plurality of ligature clips can be quickly detected by a single pressure pump, and the detection efficiency is improved. And secondly, the special structures of the clamping sleeve and the butt joint can be used for conveniently taking down the lacing rope, so that the detection efficiency of the ligation clip is further improved.

Description

Technical Field

[0001] The present invention relates to the technical field of surgical medical instruments, and in particular to a device and method for testing the withstand voltage of a ligation clip. Background Art

[0002] Ligating clips are widely used in minimally invasive surgery, primarily for clamping blood vessels and tissues. Their performance stability is crucial. Pressure testing, a key step in evaluating ligating clip performance, simulates the pressure conditions experienced during surgery to examine their stability, closure force, and sealing properties under high pressure, ensuring surgical safety and preventing blood leakage or tissue rupture.

[0003] To ensure the reliability of ligation clamps, they need to undergo a pressure test before leaving the factory. However, conventional pressure test devices for ligation clamps can only test a single ligation clamp at a time, which results in a time-consuming and tedious testing process and affects testing efficiency. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is to overcome the defect of low detection efficiency of the ligation clip detection device in the prior art.

[0005] In order to solve the above technical problems, the present invention provides a ligation clip pressure test device, comprising: A docking assembly, comprising a docking head and a ferrule, wherein a groove is provided on the surface of the docking head along the circumferential direction; the ferrule is arranged on the outside of the docking head, and a plurality of elastic sheets are provided on the surface of the ferrule along the circumferential direction, wherein the elastic sheets are arranged opposite to the groove, and a notch is formed between any two of the elastic sheets, and the notch is arranged along the axial direction of the docking head; A test assembly, which includes a pressure pump, a connecting hose, a test hose and a tightening rope. One end of the connecting hose is connected to the pressure pump, the other end of the connecting hose is connected to the docking joint, and the test hose is connected to the end of the docking joint away from the connecting hose; multiple tightening rope sleeves are arranged on the outside of the ferrule.

[0006] In one embodiment of the present invention, the pressure pump includes a tubular cavity, a piston and a propulsion rod, one end of the tubular cavity is provided with an output port, and the output port is connected to the connecting hose; the piston is provided inside the tubular cavity, one end of the propulsion rod is connected to the piston, and the propulsion rod is threadedly connected to the tubular cavity.

[0007] In one embodiment of the present invention, the surface of the lumen is provided with scales along the longitudinal axis.

[0008] In one embodiment of the present invention, a pressure gauge is provided at one end of the lumen close to the connecting hose.

[0009] In one embodiment of the present invention, a clamping arm is provided on the surface of the tube cavity, and the clamping arm is provided at an end of the tube cavity away from the connecting hose.

[0010] In one embodiment of the present invention, a buckle is provided at one end of the ferrule, and the buckle is buckled on an end of the docking joint close to the connecting hose.

[0011] In one embodiment of the present invention, a slot that cooperates with the buckle is provided on the end surface of the docking joint.

[0012] In one embodiment of the present invention, the connection hose and the test hose are all detachably connected to the docking joint.

[0013] In one embodiment of the present invention, both ends of the butt joint are tapered along the direction of the groove.

[0014] A ligation clamp pressure test method, used for testing the ligation clamp pressure test device, further comprising the following steps: S1. Use a pressure pump to draw clean water, then put the ferrule on the outside of the butt joint, set multiple tightening ropes on the ferrule, and connect the two ends of the butt joint to the test hose and the connecting hose respectively; S2. After the device to be tested is installed, adjust the pressure of the pressure pump to exhaust the test hose; S3. After the test hose is exhausted, clamp the first ligature clamp to the water outlet end of the test hose, adjust the pressure pump to the set value, remove the first tightening rope, and move the tightening rope along the test hose to the side of the first ligature clamp. A test unit is formed between the first ligature clamp and the first tightening rope. S4. Sequentially assemble the next ligature clip and tightening rope until the test units cover the entire test hose. Based on the distribution of the test units, cut the test hose between each two adjacent test units to separate the test units into multiple independent test units. S5. After the multiple independent test units are left to stand for a set time, the test data are recorded.

[0015] The above technical solution of the present invention has the following advantages over the prior art: The present invention describes a device and method for testing the pressure resistance of ligating clamps. The test hose is used to simulate blood vessels and tissues. A docking connector allows for the buffering of multiple lacing cords, enabling rapid testing of the clamping durability of multiple ligating clamps using a single pressure pump, improving testing efficiency. Furthermore, the unique structure of the ferrule and docking connector facilitates the removal of the lacing cords, further enhancing ligating clamp testing efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to make the content of the present invention more clearly understood, the present invention is further described in detail below based on specific embodiments of the present invention in conjunction with the accompanying drawings, wherein Figure 1 It is a schematic diagram of the overall structure of the present invention; Figure 2 for Figure 1 Schematic diagram of the structure of the docking assembly; Figure 3 for Figure 2 Structural cross-sectional view of the middle butt joint; Figure 4 for Figure 2 Schematic diagram of the structure of the middle ferrule; Figure 5 for Figure 1 Schematic diagram of the structure of the medium pressure pump; Figure 6 for Figure 1 Cross-sectional view of the internal structure of the medium pressure pump; Figure 7 for Figure 1 Schematic diagram of the local structure at A in the middle; Figure 8 Schematic diagram of the structure of the test unit in the present invention; Explanation of the reference numerals in the specification: 1. Docking assembly; 2. Test assembly; 3. Ligating clamp; 4. Test unit; 11. Docking joint; 12. Ferrule; 21. Pressure pump; 22. Connecting hose; 23. Test hose; 24. Tightening rope; 111. Groove; 112. Slot; 113. Taper; 121. Notch; 122. Elastic sheet; 123. Buckle; 211. Lumen; 212. Piston; 213. Push rod; 214. Scale; 215. Pressure gauge; 216. Clamp arm. DETAILED DESCRIPTION

[0017] The present invention will be further described below with reference to the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it. However, the embodiments are not intended to limit the present invention.

[0018] Reference Figure 1-Figure 3 As shown, a ligation clip pressure test device of the present invention comprises: A docking assembly 1 includes a docking head 11 and a ferrule 12. A groove 111 is formed on the surface of the docking head 11 along the circumferential direction. A plurality of elastic sheets 122 are provided on the surface of the ferrule 12 along the circumferential direction. The elastic sheets 122 are arranged opposite to the groove 111. A notch 121 is formed between any two of the elastic sheets 122. The notch 121 is arranged axially along the docking head 11. The test assembly 2 includes a pressure pump 21, a connecting hose 22, a test hose 23 and a tightening rope 24. One end of the connecting hose 22 is connected to the pressure pump 21, the other end of the connecting hose 22 is connected to the docking joint 11, and the test hose 23 is connected to the end of the docking joint 11 away from the connecting hose 22; multiple tightening ropes 24 are sleeved on the outside of the ferrule 12.

[0019] One end of the docking joint 11 in the present invention is connected to the pressure pump 21 through a connecting hose 22 to input the pressure; the other end is installed with a test hose 23 to realize the detection of the ligation clamp 3. The pressure pump 21 in the test assembly 2 is a plunger water pump, which adjusts the pressure value required for the test by pressing water into the end of the test tube. One end of the docking joint 11 is connected to the pressure pump 21 through a connecting hose 22, and the other end is connected to the test hose 23. The pressure pump 21 inputs pressure to the end of the test hose 23. The outer side of the docking joint 11 is provided with a ferrule 12, and the surface of the ferrule 12 is provided with multiple tightening ropes 24. The elastic sheet 122 and the notch 121 on the surface of the ferrule 12 can facilitate the removal of the tightening rope 24 from the docking joint 11 and tighten it to the outside of the test hose 23.

[0020] Reference Figure 2-Figure 4 As shown, as a preferred embodiment of the present invention, the lacing cord 24 has high elasticity and good resilience, can be stretched to several times its original length, and quickly returns to its original shape after the external force is removed, with minimal permanent deformation, thus ensuring its reusability. The ferrule 12 is made of spring steel. Spring steel has a high elastic limit, excellent fatigue strength, good toughness, and strength, allowing the ferrule 12 to be bent repeatedly without breaking, even at corners. It elastically deforms when subjected to force and quickly returns to its original shape after the external force is removed.

[0021] The entire butt joint 11 is hollow cylindrical, with a groove 111 formed on its surface, specifically in the middle of its axial direction. A ferrule 12 is positioned over the outside of the butt joint 11, with an elastic sheet 122 positioned directly opposite the groove 111. This creates a hollow structure between the ferrule 12 and the butt joint 11, and a gap 121 between any two adjacent elastic sheets 122 facilitates the lifting of these sheets. The cinching cord 24 is positioned over the outside of the ferrule 12 (elastic sheet 122), effectively supporting it. During operation, pulling on the elastic sheet 122 in the center of the ferrule 12 easily expands the cinching cord 24, avoiding the inconvenience of directly pulling the cinching cord 24. The cinching cord 24 can be easily removed from the butt joint 11, while also minimizing damage.

[0022] During the actual testing process, one end of the test hose 23 is used to simulate blood vessels and tissues. The specific operation is as follows: First, the first ligating clamp 3 is clamped to the end of the test hose 23 away from the docking connector 11. After adjusting the pressure pump 21 to the target pressure, a cinching cord 24 is removed from the docking connector 11 and placed over the side of the test hose 23 near the ligating clamp 3. This forms the first section of closed test hose 23 between the ligating clamp 3 to be tested and the cinching cord 24. According to Pascal's law, in a closed container, the pressure applied to a stationary fluid is transmitted equally and simultaneously to all parts of the fluid and the container wall. The pressure within the first section of test hose 23 is equal to the pressure at the end of the pressure pump 21. Multiple ligating clamps 3 and cinching cords 24 are sequentially assembled to form multiple test units 4 until the test hose 23 is fully clamped. Each set of ligating clamps 3 and cinching cords 24 forms a test unit 4. The test hose 23 is then cut to separate the test units 4 according to the number of test units 4.

[0023] The docking connector 11 of the present invention can buffer multiple lacing cords 24, enabling a single pressure pump 21 to quickly test the clamping durability of multiple ligating clamps 3, thereby improving testing efficiency. Furthermore, the unique structure of the ferrule 12 and docking connector 11 facilitates the removal of the lacing cords 24, further improving the testing efficiency of the ligating clamps 3.

[0024] Further, refer to Figure 5-Figure 6 As shown, the pressure pump 21 includes a tubular cavity 211, a piston 212 and a propulsion rod 213. An output port is provided at one end of the tubular cavity 211, and the output port is connected to the connecting hose 22; the piston 212 is provided inside the tubular cavity 211, and one end of the propulsion rod 213 is connected to the piston 212, and the propulsion rod 213 is threadedly connected to the tubular cavity 211.

[0025] Specifically, the structure of the pressure pump 21 in the present invention adopts the form of a propulsion rod 213 driving a piston 212, squeezing the water inside the lumen 211 to one end of the test hose 23. As a preferred embodiment of the present invention, the propulsion rod 213 is connected to the lumen 211 by a threaded connection, and the propulsion rod 213 is rotated to move the piston 212 inside the lumen 211. Through the threaded connection, the propulsion distance of the piston 212 inside the lumen 211 can be accurately controlled, thereby applying controllable pressure to the space in front of the lumen 211. This threaded transmission design not only realizes a self-locking function and effectively prevents the accidental release of pressure, but also changes the traditional linear propulsion method to rotary propulsion, making the pressure adjustment more accurate, convenient and controllable.

[0026] Furthermore, a scale 214 is provided on the surface of the lumen 211 along the longitudinal axis.

[0027] Specifically, the entire tubular cavity 211 is made of fiberglass, and a precise scale 214 is engraved on the outer wall thereof for accurately displaying the position of the push rod 213 and the pressure applied.

[0028] Furthermore, a pressure gauge 215 is provided at one end of the lumen 211 close to the connecting hose 22 .

[0029] Preferably, the pressure gauge 215 in the present invention is a digital pressure gauge 215, which can accurately display the pressure value output by the lumen 211, providing users with intuitive and reliable pressure values so that they can accurately adjust the pressure according to actual needs.

[0030] Furthermore, a clamping arm 216 is provided on the surface of the lumen 211, and is provided at the end of the lumen 211 away from the connecting hose 22. This allows the clamping arm 216 to be securely clamped on a tabletop of suitable thickness for easy operation. Furthermore, the groove 111 at the lower end of the clamping arm 216 is ergonomically designed, making the grip more secure and comfortable, and improving the stability and convenience of operation.

[0031] Further, refer to Figure 4 As shown, a buckle 123 is provided at one end of the ferrule 12 , and the buckle 123 is buckled onto one end of the docking joint 11 close to the connecting hose 22 .

[0032] Specifically, during the actual installation process, the ferrule 12 is fitted onto the outside of the docking connector 11. The tension of the ferrule 12 improves the stability of the connection between the test hose 23 and the connecting hose 22 and the docking connector 11. Secondly, during actual operation, the tightening cord 24 on the outer sleeve needs to be removed and moved toward one end of the test tube. To prevent friction between the tightening cord 24 and the ferrule 12 that could cause the ferrule 12 to separate from the docking connector 11, a buckle 123 is provided on the end of the ferrule 12 near the connecting hose 22 to limit its displacement.

[0033] Furthermore, a slot 112 that cooperates with the buckle 123 is provided on the end surface of the docking head 11 .

[0034] Specifically, during actual operation, one end of the ferrule 12 provided with the buckle 123 is embedded in the card slot 112 to further ensure the stability of the connection between the ferrule 12 and the docking head 11.

[0035] Furthermore, the connection hose 22 and the test hose 23 are all detachably connected to the docking joint 11 .

[0036] Specifically, the two ends of the butt joint 11 are connected to the connecting hose 22 and the test hose 23 through a connector. As a preferred solution of the present invention, an interference fit is adopted between the two ends of the connector and the butt joint 11 and the hose to ensure that the connection can remain tight and will not be disconnected when the high-pressure liquid flows through.

[0037] Furthermore, both ends of the butt joint are provided with tapers 113 along the groove direction.

[0038] Specifically, by setting the taper 113 on the surface of the joint 11, on the one hand, the area where the tightening rope 24 is installed can be increased, which facilitates the subsequent removal of the tightening rope 24; on the other hand, a smooth transition can be made between the ferrule 23 and the joint 11. When multiple tightening ropes 24 are installed on the outside of the ferrule, the stress of the elastic sheet at the corner can be reduced, thereby reducing the fatigue strength of the elastic sheet 122 and extending the service life of the elastic sheet 122.

[0039] As a preferred embodiment of the present invention, the outer diameter of the test hose 23 is 5mm-10mm, and the wall thickness is 0.9mm-1.1mm. During actual testing, the test hose 23 was tested in sizes of 5mm, 7mm, and 10mm, with a wall thickness of 1mm and a thickness tolerance of no more than ±0.1mm. The hardness was 30HA ± 5HA. A water pressure of 50kPa was applied to the silicone tube and maintained for 72 hours. The ligating clamp 3 was deemed qualified if, after 72 hours of exposure to 50kPa water pressure, there was no leakage, no disengagement, breakage, or slippage of the latch.

[0040] Reference Figure 7-Figure 8 As shown, the present invention also discloses a ligation clip pressure test method, which is used for testing the ligation clip 3 pressure test device, and further includes the following steps: S1. Use a pressure pump 21 to draw clean water, then put the ferrule 12 on the outside of the butt joint 11, put multiple tightening ropes 24 on the ferrule 12, and connect the two ends of the butt joint 11 to the test hose 23 and the connecting hose 22 respectively; In step S1, the pressure pump 21 is first filled with water, and then the various components of the entire device are assembled. During the assembly process, the ferrule 12 is first placed on both ends of the docking head 11, and then an appropriate amount of tightening rope 24 is placed on the outside of the ferrule 12. Finally, the test hose 23 and the connecting hose 22 are connected to the ends of the docking head 11. It is important to ensure that the end of the ferrule 12 with the buckle 123 is connected to the connecting hose 22 to prevent the ferrule 12 from falling off when the tightening rope 24 is subsequently removed.

[0041] S2. After the device to be tested is installed, adjust the pressure of the pressure pump 21 and exhaust the test hose 23. In step S2, the entire pipeline needs to be vented first to ensure that there are no bubbles in the entire pipeline. During the venting process, one end of the test hose 23 is higher than the hydraulic pump, and then the push rod 213 is rotated to make water flow out from the end of the test hose 23 until no bubbles are discharged.

[0042] S3. After the test hose 23 is exhausted, the first ligating clamp 3 is clamped to the water outlet end of the test hose 23. The pressure pump 21 is adjusted to the set value. The first tightening rope 24 is removed. The tightening rope 24 is moved along the test hose 23 to one side of the first ligating clamp 3. A test unit 4 is formed between the first ligating clamp 3 and the first tightening rope 24. In step S3, after the exhaust is completed, the first ligation clamp 3 is clamped on one end of the test hose 23 to seal the entire pipeline; the push rod 213 is rotated to adjust the pressure pump 21, and the value of the pressure gauge 215 is observed. When the pressure value reaches 50kPa, the first (close to the test hose 23 side) tightening rope 24 on the ferrule 12 is removed, and the tightening rope 24 is moved along the test hose 23 to the side of the first ligation clamp 3. A liquid column with pressure at one end is formed between the first ligation clamp 3 and the first tightening rope 24.

[0043] S4, sequentially assemble the next ligating clip 3 and the tightening rope 24 until the test units 4 cover the entire test hose 23. Based on the distribution of the test units 4, cut the test hose 23 between each two adjacent test units 4 to separate the test units 4 into multiple independent test units 4; In step S4, before each application of the lacing cord 24, the pressure gauge 215 should be checked to see if it is 50 kPa. If the pressure is inaccurate, the pressure should be adjusted to 50 kPa before tightening the lacing cord 24. It should be noted that sufficient distance must be left between adjacent test units 4 to ensure that the lacing clamp 3 and lacing cord 24 can effectively tighten the test hose 23.

[0044] S5. After the multiple independent test units 4 are left to stand for a set time, the test data are recorded.

[0045] In step S5, the multiple independent test units are left to rest for 72 hours to simulate the vessel healing time, and the ligation clamp 3 is tested to see if it maintains the vessel seal within this time. Specifically, during actual operation, the condition of each test unit 4 is recorded and evaluated. If one side of the ligation clamp 3 leaks, the seal of the ligation clamp 3 is deemed unsatisfactory.

[0046] In summary, the present invention introduces a device and method for testing the pressure resistance of a ligating clamp. The specific operation is as follows: First, clamp the first ligating clamp 3 onto the end of a test hose 23 away from the docking connector 11. After adjusting the pressure pump 21 to the target pressure, remove a cinching cord 24 from the docking connector 11 and place it over the side of the test hose 23 near the ligating clamp 3. This forms the first section of a closed test hose 23 between the ligating clamp 3 to be tested and the cinching cord 24. According to Pascal's law, which states that pressure applied to a stationary fluid in a closed container is transmitted simultaneously and equally to all parts of the fluid and the container wall, the pressure within the first section of the test hose 23 is equal to the pressure at the end of the pressure pump 21. Repeat these steps until the test hose 23 is fully clamped. Each set of ligating clamps 3 and cinching cords 24 forms a test unit 4. The test hose 23 is then cut and separated into multiple separate test units 4, depending on the number of test units 4. Finally, after the test time is completed, each test unit 4 is observed to see if there is any water leakage, so as to determine whether the sealing performance of the ligation clip 3 is qualified.

[0047] The test hose 23 in this invention simulates blood vessels and tissues. The docking connector 11 allows for the buffering of multiple lacing cords 24, enabling rapid testing of the clamping durability of multiple ligating clips 3 using a single pressure pump 21, improving testing efficiency. Furthermore, the unique structure of the ferrule 12 and docking connector 11 facilitates the removal of the lacing cords 24, further enhancing testing efficiency for the ligating clips 3.

[0048] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will appreciate that other variations or modifications can be made based on the above description. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A ligation clip pressure test device, characterized in that: include: A docking assembly, comprising a docking head and a ferrule, wherein a groove is provided on the surface of the docking head along the circumferential direction; the ferrule is arranged on the outside of the docking head, and a plurality of elastic sheets are provided on the surface of the ferrule along the circumferential direction, wherein the elastic sheets are arranged opposite to the groove, and a notch is formed between any two of the elastic sheets, and the notch is arranged along the axial direction of the docking head; A test assembly, which includes a pressure pump, a connecting hose, a test hose and a tightening rope. One end of the connecting hose is connected to the pressure pump, the other end of the connecting hose is connected to the docking joint, and the test hose is connected to the end of the docking joint away from the connecting hose; multiple tightening rope sleeves are arranged on the outside of the ferrule.

2. The ligation clip pressure test device according to claim 1, characterized in that: The pressure pump includes a tubular cavity, a piston and a propulsion rod. An output port is provided at one end of the tubular cavity, and the output port is connected to the connecting hose. The piston is provided inside the tubular cavity, one end of the propulsion rod is connected to the piston, and the propulsion rod is threadedly connected to the tubular cavity.

3. The ligation clip pressure test device according to claim 2, characterized in that: The surface of the lumen is provided with scales along the longitudinal axis.

4. The ligation clip pressure test device according to claim 2, characterized in that: A pressure gauge is provided at one end of the tube cavity close to the connecting hose.

5. The ligation clip pressure test device according to claim 2, characterized in that: A clamping arm is provided on the surface of the tube cavity, and the clamping arm is provided at an end of the tube cavity away from the connecting hose.

6. The ligation clip pressure test device according to claim 1, characterized in that: One end of the ferrule is provided with a buckle, and the buckle is buckled on the end of the docking joint close to the connecting hose.

7. The ligation clip pressure test device according to claim 6, characterized in that: A clamping groove that cooperates with the buckle is provided on the end surface of the docking joint.

8. The ligation clip pressure test device according to claim 1, characterized in that: The connecting hose and the testing hose are all detachably connected to the docking joint.

9. The ligation clip pressure test device according to claim 1, characterized in that: Both ends of the butt joint are provided with tapers along the direction of the groove.

10. A ligating clip pressure test method, used for testing the ligating clip pressure test device according to any one of claims 1 to 9, characterized in that: The following steps are also included: S1. Use a pressure pump to draw clean water, then put the ferrule on the outside of the butt joint, set multiple tightening ropes on the ferrule, and connect the two ends of the butt joint to the test hose and the connecting hose respectively; S2. After the device to be tested is installed, adjust the pressure of the pressure pump to exhaust the test hose; S3. After the test hose is exhausted, clamp the first ligature clamp to the water outlet end of the test hose, adjust the pressure pump to the set value, remove the first tightening rope, and move the tightening rope along the test hose to the side of the first ligature clamp. A test unit is formed between the first ligature clamp and the first tightening rope. S4. Sequentially assemble the next ligature clip and tightening rope until the test units cover the entire test hose. Based on the distribution of the test units, cut the test hose between each two adjacent test units to separate the test units into multiple independent test units. S5. After the multiple independent test units are left to stand for a set time, the test data are recorded.

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