A vascular suture device

Abstract

This invention relates to the field of medical device technology and provides a vascular suture device, including a needle handle assembly, a housing, a wrench, a marking cavity, a suture assembly, and a sheath assembly. The needle handle assembly includes a needle handle, a needle handle connector, and a needle fixing component. The distal end of the needle fixing component is provided with a solid needle and a hollow needle tube, and one end of the needle handle is provided with a push needle. A safety device is provided inside the housing, which includes a limiting post and a limiting block. The limiting block has an arc-shaped groove and a guide post, and the housing has a guide oblique groove. The suture assembly includes an outer tube, a suture arm, a suture lead, a suture lead pull suture, a needle sheath, a bridging suture, a needle tip, and suture thread. This device can solve the hemostasis problem after femoral artery puncture, and can prevent user errors during use. It is convenient to operate and highly safe.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a vascular suture device. Background Technology

[0002] Interventional surgery has become the preferred treatment option for cardiovascular diseases such as aneurysms, vascular stenosis, and acute myocardial infarction in recent years. With its advantages of minimal invasiveness, high efficiency, precise treatment, and safety, interventional surgery has become the third most common clinical treatment after surgery and internal medicine. Interventional surgery relies heavily on vascular puncture, with femoral artery puncture being not only a classic route for coronary intervention but also accounting for 90% of puncture routes in peripheral interventional procedures. However, hemostasis after femoral artery puncture has always been a challenge for clinicians. Traditional hemostasis methods involve manual pressure, requiring up to 25 minutes of pressure on the puncture site, and the patient must remain in bed for an extended period afterward. This is not only time-consuming and labor-intensive for medical staff but also inconvenient for patients who cannot lie flat for extended periods. Therefore, there is an urgent need for a hemostatic device that offers significant hemostasis, a safe and reliable vascular closure method, a wide range of puncture site applications, and postoperative remedial capabilities.

[0003] Vascular suture devices are common medical devices used for suturing vascular puncture sites in existing technology. However, existing vascular suture devices lack safety devices, and users often mistakenly pull the needle handle assembly directly from the vascular suture device without connecting the needle sheath during operation, rendering the entire device unusable. Summary of the Invention

[0004] The purpose of this invention is to provide a vascular suture device that addresses the problems mentioned in the background section.

[0005] The present invention is implemented as follows: a vascular suture device includes a needle handle assembly, a housing, a wrench, a marking cavity, a suture assembly, and a sheath assembly;

[0006] The needle handle assembly is installed in the housing. The needle handle assembly includes a needle handle, a needle handle connector and a needle fixing member. A solid needle and a hollow needle tube are provided at the distal end of the needle fixing member. A push needle is provided at one end of the needle handle. The needle handle and the needle fixing member are connected to each other through the needle handle connector, and the push needle is located inside the hollow needle tube.

[0007] The housing is equipped with a safety device, which includes a limiting post on the needle handle connector and a limiting block on one side of the needle handle connector. The limiting block is provided with an arc-shaped groove that matches the limiting post, and a guide post is provided on the limiting block. The housing is also provided with a guide groove that matches the guide post.

[0008] The suture assembly includes an outer tube, a suture arm, a suture lead, a suture lead puller, a needle sheath, a bridge suture, a needle tip, and a suture thread; wherein:

[0009] The thread foot is located in the distal groove of the sewing arm. The middle of the thread foot has a first slot for placing the thread puller. The thread foot is connected to the wrench through the thread puller and the internal connecting mechanism. The needle sleeve has a top end, a bottom end, and a through hole that passes through both ends. The through hole is used to insert the bridge thread. The bottom end is one end connected to the end of the bridge thread. One or more pressure plates that can be pressed into the through hole are provided on the side wall of the needle sleeve near the top end.

[0010] The left and right ends of the thread foot each have a through second slot. Each second slot has a needle sleeve in its needle sleeve placement area. The two needle sleeves are connected to each other by a bridging thread. The far end of the needle sleeve placement area is connected to the needle sleeve outlet hole to form an inward bottom step. The ends of the two needle sleeves connected to the bridging thread face the needle sleeve outlet hole of the thread foot. The bridging thread on the needle sleeve that is connected to the solid needle passes through the bottom step and wraps back to the thread foot. It then passes through the bridging thread hanging hole on the sewing arm and the needle sleeve outlet hole at the other end of the thread foot, and finally connects with the needle sleeve at the other end of the thread foot.

[0011] The suture is connected to the distal end of the solid needle via a pre-made fisherman's knot. The needle tip is placed on the head end of the hollow needle tube. The end of the suture away from the solid needle is connected to the needle tip, and the suture at the tail of the needle tip emerges from a groove on the side of the distal end of the hollow needle tube. The distal end of the needle tip has a head and neck with a structure similar to the distal end of the solid needle. The tail end of the needle tip is inserted into the hollow needle tube.

[0012] In a further technical solution, the needle sheath is generally made of metal, with an outer diameter of 0.4-0.6 mm, a wall thickness of 0.03 mm-0.08 mm, and a height of 1 mm-1.5 mm.

[0013] In a further technical solution, the shape of the compressed tablet can be rectangular, trapezoidal, triangular, or other arbitrary shapes.

[0014] In a further technical solution, the bottom end can be conical or cylindrical, while the top end is generally cylindrical.

[0015] In a further technical solution, the bridging wire is generally made of polytetrafluoroethylene (PTFE), but other materials are also possible, with a diameter of approximately 0.2-0.5 mm. The end of the bridging wire inside the needle sheath is generally a tight, thick end, with a length of 0.2-0.5 mm. The needle sheath and the bridging wire can be connected by stamping, heating, barbs, or other methods.

[0016] In a further technical solution, the leads are generally made of plastic.

[0017] In a further technical solution, the needle sheath placement area can be cylindrical, V-groove, or other shapes. The proximal end of the needle sheath placement area is connected to a guide slope. The guide slope is generally an opening that expands towards the proximal end and can be conical or other shapes, used to increase the allowable range of needle-needle docking and improve the docking accuracy of needle-needle.

[0018] In a further technical solution, the diameter of the needle sleeve outlet hole is usually smaller than the outer diameter of the needle sleeve, and can be cylindrical, V-groove, or other shapes.

[0019] In a further technical solution, the tail of the needle can be connected to the suture by adhesive bonding, heat fusion, riveting, or other methods.

[0020] In a further technical solution, the vascular suture device also includes an assembly assembly, which is used to assemble the solid needle and the hollow needle tube onto the needle fixing component, and simultaneously detect whether the length and diameter of the solid needle and the hollow needle tube are qualified.

[0021] The assembly includes a positioning plate, on which two elastic connectors for fixing the needle handle connector are symmetrically arranged. Two placement platforms are arranged on the positioning plate along the same straight line. Each of the two placement platforms is provided with a V-shaped placement groove that matches the solid needle and the hollow needle tube. Two electric push rods are also symmetrically arranged on the positioning plate. Each of the telescopic ends of the two electric push rods is provided with a push plate.

[0022] A first distance detector is provided between the two placement platforms. The upper surface of the first distance detector is flush with the bottom of the V-shaped placement groove, and is used to detect the distance between the solid needle and the hollow needle tube and the bottom of the V-shaped placement groove.

[0023] A second distance detector is provided on each side of the first distance detector, and the two second distance detectors are used to detect the distance between the two push plates respectively.

[0024] Further technical solutions also include an evaluation system for assessing the quality of solid needles and hollow needle tubes, including:

[0025] The information acquisition module is used to acquire the length and diameter information of the solid needle and the hollow needle tube, which are denoted as Cs, Ck, Ds and Dk respectively;

[0026] The storage module is used to store the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube obtained by the information acquisition module.

[0027] The processing module retrieves the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube from the storage module, and evaluates the quality of the vascular suture device based on these four information, specifically:

[0028] S1. Based on the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube, obtain the length deviation value of the solid needle, the diameter deviation value of the solid needle, the length deviation value of the hollow needle, and the diameter deviation value of the hollow needle.

[0029] S2. The obtained solid needle length deviation value, solid needle diameter deviation value, hollow needle tube length deviation value, and hollow needle tube diameter deviation value are compared with the preset solid needle length deviation threshold, solid needle diameter deviation threshold, hollow needle tube length deviation threshold, and hollow needle tube diameter deviation threshold. If any one of them is not within the corresponding threshold, it indicates that the vascular suture device is unqualified.

[0030] S3. After dimensionless processing of the length deviation value of the solid needle, the diameter deviation value of the solid needle, the length deviation value of the hollow needle tube, and the diameter deviation value of the hollow needle tube, correlation is performed to form evaluation condition coefficients. The obtained evaluation condition coefficients are compared with preset condition coefficient thresholds. If they exceed the condition coefficient thresholds, it indicates that the vascular suture device is unqualified. The correlation model of the evaluation condition coefficients is expressed as follows:

[0031]

[0032] in, To evaluate the condition coefficient, The quality assessment coefficient for solid needles. This is the quality assessment coefficient for hollow syringes. This is the length deviation value of the solid needle. This is the diameter deviation value of the solid needle. This is the length deviation value of the hollow needle tube. This represents the diameter deviation value of the hollow needle tube. The weight value of the quality assessment coefficient for solid needles. This represents the weighted value of the quality assessment coefficient for hollow syringes. The influencing factor of the solid needle length deviation value. The influencing factor of the solid needle diameter deviation value. The influencing factor of the length deviation value of the hollow needle tube. The influencing factor for the diameter deviation of the hollow needle tube. , , + =1, , , + =1, , , + =1.

[0033] This invention provides a vascular suturing device. After the sheath assembly of the vascular suture device enters the blood vessel lumen, the wrench is used to unfold the suture threads and press them against the blood vessel walls on both sides of the puncture point. The needle handle is pushed to connect the solid needle and needle tip to two needle sheaths, respectively. Then, the needle is pulled out, allowing the suture to pass through a pre-set fisherman's knot. The suture threads are then gathered up, the vascular suture device is removed, and finally, the remaining suture threads on both sides of the puncture point on the blood vessel wall are pushed, locked, and cut. Simultaneously, when the needle handle is pushed to connect the solid needle and needle tip to the two needle sheaths, the limiting block in the safety device automatically moves towards the direction of needle tip and needle sheath connection according to a fixed sliding trajectory. After the needle tip and needle sheath are connected, the limiting block moves to the automatic release stop position, at which point the limiting block releases its restriction on the limiting post, thereby releasing the stop safety. This vascular suturing mechanism with a safety device solves the hemostasis problem after femoral artery puncture and prevents the user from accidentally pulling out the needle handle assembly before connecting it to the needle sheath. It is convenient to operate and highly safe. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the structure of a vascular suture device provided in an embodiment of the present invention;

[0035] Figure 2 This is a schematic diagram of the needle handle assembly in a vascular suture device according to an embodiment of the present invention;

[0036] Figure 3 This is a partial structural schematic diagram of a vascular suture device provided in an embodiment of the present invention;

[0037] Figure 4 This is a partial cross-sectional view of a vascular suturing device provided in an embodiment of the present invention;

[0038] Figure 5 for Figure 4 Sectional view along axis AA;

[0039] Figure 6 for Figure 5 Enlarged view of point B in the image;

[0040] Figure 7 This is a schematic diagram of the structure of a limiting block in a vascular suture device provided in an embodiment of the present invention;

[0041] Figure 8This is a schematic diagram of the structure of a suture assembly in a vascular suture device provided in an embodiment of the present invention;

[0042] Figure 9 This is a schematic diagram of the needle sheath in a vascular suture device provided in an embodiment of the present invention;

[0043] Figure 10 This is a schematic diagram of the structure of a vascular suture device during docking, provided in an embodiment of the present invention;

[0044] Figure 11 This is a schematic diagram of the structure of a vascular suture device according to an embodiment of the present invention, showing the cooperation between a needle and a hollow needle tube.

[0045] Figure 12 This is a schematic diagram of the structure of an assembly component in a vascular suture device according to an embodiment of the present invention;

[0046] Figure 13 This is a partial structural diagram of an assembly component in a vascular suture device provided in an embodiment of the present invention.

[0047] In the attached diagram: needle handle assembly 1; needle handle 11; push needle 111; needle handle connector 12; needle fixing component 13; solid needle 131; hollow needle tube 132; head end 1321; groove 1322; outer shell 2; safety device 21; limiting post 211; limiting block 222; guide post 223; guide groove 224; wrench 3; marking cavity 4; suture assembly 5; outer tube 51; suture arm 52; distal groove 521; bridging suture hanging hole 522; suture foot 53; first slot 531; second slot 532; needle sheath placement area 5321; Guide slope 5322; needle sleeve outlet 5323; side groove 5324; thread pull 54; needle sleeve 55; top end 551; bottom end 552; pressure plate 553; bridging thread 56; needle 57; suture 58; fisherman's knot 581; sheath assembly 6; assembly assembly 7; positioning plate 71; elastic connector 72; side plate 721; clamping plate 722; sliding rod 723; spring 724; placement platform 73; V-shaped placement groove 731; first distance detector 74; electric push rod 75; push plate 76; second distance detector 77. Detailed Implementation

[0048] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0049] The specific implementation of the present invention will be described in detail below with reference to specific embodiments.

[0050] like Figure 1-11As shown, a vascular suturing device according to an embodiment of the present invention includes a needle handle assembly 1, a housing 2, a wrench 3, a marking cavity 4, a suturing assembly 5, and a sheath assembly 6;

[0051] The needle handle assembly 1 is installed in the housing 2. The needle handle assembly 1 includes a needle handle 11, a needle handle connector 12, and a needle fixing member 13. The distal end of the needle fixing member 13 (defined as the end of the needle fixing member 13 away from the needle handle connector 12) is provided with a solid needle 131 and a hollow needle tube 132. One end of the needle handle 11 is provided with a push needle 111. The needle handle 11 and the needle fixing member 13 are connected together by the needle handle connector 12, and the push needle 111 is located inside the hollow needle tube 132.

[0052] The housing 2 is provided with a safety device 21. The safety device 21 includes a limiting post 211 provided on the needle handle connector 12 and a limiting block 222 provided on one side of the needle handle connector 12. The limiting block 222 is provided with an arc-shaped groove that matches the limiting post 211. The limiting block 222 is provided with a guide post 223. The housing 2 is provided with a guide groove 224 that matches the guide post 223.

[0053] The suture assembly 5 includes an outer tube 51, a suture arm 52, a thread foot 53, a thread foot puller 54, a needle sheath 55, a bridging thread 56, a needle tip 57, and a suture 58. The thread foot 53 is located in the distal groove 521 of the suture arm 52. The middle part of the thread foot 53 has a first slot 531 for placing the thread foot puller 54. The thread foot 53 is connected to the wrench 3 through the thread foot puller 54 and an internal connecting mechanism (a connecting mechanism in the prior art can be used here, which will not be described in detail here). The thread foot 53 can be opened and closed by rotating the wrench 3.

[0054] The needle sleeve 55 has a top end 551, a bottom end 552 and a through hole through both ends. The through hole is used to insert the cross-bridge wire 56. The bottom end 552 is one end connected to the end of the cross-bridge wire. One or more pressure plates 553 that can be pressed into the through hole are provided on the side wall of the needle sleeve 55 near the top end 552.

[0055] The two ends of the bridging wire 56 are respectively connected to the bottom end 552 of a needle sleeve 55;

[0056] The left and right ends of the thread 53 each have a through second slot 532. The middle part of the second slot 532 is a needle sheath placement area 5321 for accommodating the needle sheath 55. The distal end of the needle sheath placement area 5321 connects with the needle sheath outlet 5323 to form an inwardly recessed bottom step. The second slot 532 has a longitudinally penetrating lateral groove 5324 with its opening facing the outer sides of the left and right ends of the thread. The lateral groove 5324 is used to provide outward expansion deformation of the thread when the needle sheath is pushed out of the thread after the needle and needle sheath are mated, so that the needle sheath 55 can be smoothly pushed out of the thread. Two needle sleeves 55 connected by bridging thread 56 are placed in needle sleeve placement area 5321. The ends of the two needle sleeves 55 connected to the bridging thread 56 face the needle sleeve exit hole 5323 of the thread foot 53. The bridging thread 56 on the needle sleeve 55 that is connected to the solid needle 131 goes back to the thread foot 53 through the bottom step, and passes through the bridging thread hanging hole 522 on the sewing arm 52 and the needle sleeve exit hole 5323 at the other end of the thread foot 53, and finally connects with the needle sleeve 55 at the other end of the thread foot 53 (this needle sleeve 55 is used to connect the needle tip 57).

[0057] The suture 58 is connected to the distal end of the solid needle 131 via a pre-made fisherman's knot 581. During suturing, the suture is pulled through the pre-made fisherman's knot 581 to close the puncture site. One end of the fisherman's knot 581 extends through the instrument body to the proximal end of the outer shell 2. The needle 57 is placed on the head end 1321 of the hollow needle tube 132. The end of the suture 58 away from the solid needle 131 is connected to the needle 57, and the suture 58 at the tail of the needle 57 can pass through the groove 1322 on the distal side of the hollow needle tube 132. The distal end of 7 has a head and neck with a structure similar to the distal end of the solid needle 131. The outer diameter of the tail end of the needle 57 matches the inner diameter of the hollow needle tube 132. The front end of the tail of the needle 57 has a step that contacts the distal end of the hollow needle tube 132. When the needle handle assembly 1 is pushed, the hollow needle tube 132 can push the needle 57 forward. The pusher needle 111 in the hollow needle tube 132 can push the needle 57 off the hollow needle tube 132. The distal end 1111 of the pusher needle 111 can be flat, oblique, or any other arbitrary shape.

[0058] In this embodiment of the invention, during vascular suturing, the instrument is advanced along the guidewire until the guidewire outlet in the sheath assembly 6 is just above the skin suture, and then the guidewire is removed. The instrument is continued to be advanced until a distinct pulsating blood flow appears in the marked cavity 4. The instrument is positioned at a 45-degree angle, and the suture foot 53 is unfolded by rotating the wrench 3. The instrument is slowly pulled back so that the suture foot 53 is against the anterior wall of the blood vessel. The needle handle assembly 1 is pushed until the needle handle collar contacts the proximal end of the outer shell 2, so that the solid needle 121 and the needle tip 57 are respectively aligned with the needle sleeves 55 at both ends of the suture foot 53. The needle handle assembly 1 is pulled back until the needle handle 11 and the needle tip 57 are completely removed from the instrument body and the suture 58 is tightened. The needle handle assembly 1 with suture 58 is wound around the quick-cutting blade on the handle to cut the distal suture at the front of the needle tip 57. The reset wrench 3 closes the suture foot 53, the vascular suture instrument is removed until the guide wire port is removed from the skin suture, the end of the suture is pulled back, the vascular suture device is removed, and the suture is pushed and cut using the suture cutting device attached to the device to complete the suture.

[0059] like Figure 9 As shown, in a preferred embodiment of the present invention, the needle sheath 55 is generally made of metal, the bottom end 552 can be conical or cylindrical, and the top end 551 is generally cylindrical. In this embodiment, the bottom end 552 is conical. The outer diameter of the needle sheath 55 is 0.4-0.6 mm, the wall thickness is 0.03 mm-0.08 mm, and the height is 1 mm-1.5 mm. The shape of the pressure plate 553 can be rectangular, trapezoidal, triangular, or other arbitrary shapes.

[0060] like Figure 8 and 10 As shown, in a preferred embodiment of the present invention, the bridging wire 56 is generally made of polytetrafluoroethylene (PTFE), but can also be made of other materials, with a diameter of approximately 0.2-0.5 mm. The end of the bridging wire 56 inside the needle sleeve 55 is generally a tight, thick end, with a length of approximately 0.2-0.5 mm. The needle sleeve 55 and the bridging wire 56 can be connected by stamping, heating, barbs, or other methods.

[0061] like Figure 10 As shown in the preferred embodiment of the present invention, the lead 53 is generally made of plastic. The needle sheath placement area 5321 can be cylindrical, V-groove, or other shapes. The proximal end of the needle sheath placement area 5321 (the end closest to the outer shell 2) is connected to the guide slope 5322. The guide slope 5322 is generally an opening that widens towards the proximal end and can be conical or other shapes, used to increase the allowable range of the needle and needle sheath 55 docking and improve the docking accuracy of the needle and needle sheath 55.

[0062] The diameter of the needle sleeve outlet hole 5323 is usually smaller than the outer diameter of the needle sleeve 55, and can be cylindrical, V-groove or other shapes.

[0063] In a preferred embodiment of the present invention, the tail of the needle 57 and the suture 58 may be connected by adhesive, heat fusion, riveting or other means.

[0064] Working principle: After the sheath assembly 6 of the vascular suture device enters the blood vessel lumen, the control wrench 3 unfolds the suture 53 and presses it against the blood vessel wall on both sides of the puncture point; push the needle handle 11 to connect the solid needle 131 and the needle tip 57 to the two needle sleeves 55 as one unit, then pull out the needle to let the suture 58 pass through the pre-set fisherman's knot 581, gather up the suture 53, remove the vascular suture device, and finally push, lock, and cut the suture left on both sides of the puncture point on the blood vessel wall. At the same time, when the needle handle 11 is operated to connect the solid needle 131 and the needle head to the two needle sleeves 55 respectively, the limiting block 222 in the safety device also automatically moves in the direction of connecting the needle head 57 and the needle sleeve 55 according to the fixed sliding trajectory (the guide post 223 slides along the guide groove 224). When the needle head 57 and the needle sleeve 55 are connected, the limiting block 222 moves to the automatic release stop position. At this time, the limiting block 222 will release the limit on the limiting post 211, thereby releasing the stop safety.

[0065] like Figure 12 and 13 As shown, in a preferred embodiment of the present invention, the vascular suture device further includes an assembly component 7, which is used to assemble the solid needle 131 and the hollow needle tube 132 onto the needle fixing member 13, and simultaneously detect whether the length and diameter of the solid needle 131 and the hollow needle tube 132 are qualified.

[0066] The assembly component 7 includes a positioning plate 71. Two elastic connectors 72 for fixing the needle handle connector 12 are symmetrically arranged on the positioning plate 71. Two placement platforms 73 are arranged along the same straight line on the positioning plate 71. Each of the two placement platforms 73 is provided with a V-shaped placement groove 731 that matches the solid needle 131 and the hollow needle tube 132. Two electric push rods 75 are also symmetrically arranged on the positioning plate 71. Each of the telescopic ends of the two electric push rods 75 is provided with a push plate 76.

[0067] A first distance detector 74 is provided between the two placement platforms 73. The upper surface of the first distance detector 74 is flush with the bottom of the V-shaped placement groove 731 and is used to detect the distance between the solid needle 131 and the hollow needle tube 132 and the bottom of the V-shaped placement groove 731.

[0068] A second distance detector 77 is provided on each side of the first distance detector 74, and the two second distance detectors 77 are used to detect the distance between the two push plates 76.

[0069] In this embodiment of the invention, during use, the needle handle connector 12 is first placed on the positioning plate 71 and fixed by two elastic connectors 72. Then, the solid needle 131 and the hollow needle tube 132 are placed in the corresponding V-shaped placement grooves 731. The distance between the bottom of the solid needle 131 and the hollow needle tube 132 and the bottom of the V-shaped placement groove 731 is detected by the first distance detector 74 to determine whether the diameter of the solid needle 131 and the hollow needle tube 132 is qualified. After the detection is qualified, the electric push rod 75 is controlled to retract, thereby driving the solid needle 131 and the hollow needle tube 132 to move towards the needle fixing member 13 through the push plate 76, thereby inserting the solid needle 131 and the hollow needle tube 132 into the needle fixing member 13. At the same time, the distance between the solid needle 131 and the hollow needle tube 132 and the push plate 76 is detected by the second distance detector 77 to determine whether the length of the solid needle 131 and the hollow needle tube 132 is qualified.

[0070] like Figure 12 As shown, in a preferred embodiment of the present invention, the elastic connector 72 includes a side plate 721 mounted on the positioning plate 71. A clamping plate 722 is provided on the side of the side plate 721 facing the needle handle connector 12. The clamping plate 722 is connected to the side plate 721 through a sliding rod 723, and the sliding rod 723 passes through the side plate 721 and can slide. A plurality of springs 724 are connected between the side plate 721 and the clamping plate 722.

[0071] It also includes an evaluation system for assessing the quality of the solid needle 131 and the hollow needle tube 132, including:

[0072] The information acquisition module is used to acquire the length and diameter information of the solid needle 131 and the hollow needle tube 132, which are denoted as Cs, Ck, Ds and D respectively.

[0073] The storage module is used to store the length information Cs of the solid needle 131, the length information Ck of the hollow needle tube 132, the diameter information Ds of the solid needle 131, and the diameter information Dk of the hollow needle tube 132 obtained by the information acquisition module.

[0074] The processing module retrieves the length information Cs of the solid needle 131, the length information Ck of the hollow needle tube 132, the diameter information Ds of the solid needle 131, and the diameter information Dk of the hollow needle tube 132 from the storage module, and evaluates the quality of the vascular suture device based on these four information, specifically:

[0075] S1. Based on the length information Cs of the solid needle 131, the length information Ck of the hollow needle tube 132, the diameter information Ds of the solid needle 131, and the diameter information Dk of the hollow needle tube 132, obtain the length deviation value of the solid needle 131, the diameter deviation value of the solid needle 131, the length deviation value of the hollow needle 132, and the diameter deviation value of the hollow needle 132.

[0076] S2. The obtained length deviation value of solid needle 131, diameter deviation value of solid needle 131, length deviation value of hollow needle tube 132, and diameter deviation value of hollow needle tube 132 are compared with the preset solid needle length deviation threshold, solid needle diameter deviation threshold, hollow needle tube length deviation threshold, and hollow needle tube diameter deviation threshold. If any one of them is not within the corresponding threshold, it indicates that the vascular suture device is unqualified.

[0077] S3. After dimensionless processing of the length deviation value of solid needle 131, the diameter deviation value of solid needle 131, the length deviation value of hollow needle tube 132, and the diameter deviation value of hollow needle tube 132, correlation is performed to form evaluation condition coefficients. The obtained evaluation condition coefficients are compared with preset condition coefficient thresholds. If they exceed the condition coefficient thresholds, it indicates that the vascular suture device is unqualified. The correlation model of the evaluation condition coefficients is expressed as follows:

[0078]

[0079] in, To evaluate the condition coefficient, The quality assessment coefficient for solid needle 131. The quality assessment coefficient for hollow needle tube 132. This is the length deviation value for solid needle 131. This is the diameter deviation value for solid needle 131. This is the length deviation value of the hollow needle tube 132. This is the diameter deviation value of the hollow needle tube 132. The weight value of the quality assessment coefficient for solid needle 131. The weighted value of the quality assessment coefficient for hollow needle tube 132. The influencing factor for the length deviation value of solid needle 131 The influencing factor of the diameter deviation value of solid needle 131 The influencing factor for the length deviation value of hollow needle tube 132. The influencing factor for the diameter deviation of the hollow needle tube 132 is 0. 0 , + =1,0 0 , + =1,0 0 , + =1.

[0080] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A vascular suture device, characterized in that, Includes needle handle assembly, housing, wrench, marking chamber, suture assembly, and sheath assembly; The needle handle assembly is installed in the housing. The needle handle assembly includes a needle handle, a needle handle connector and a needle fixing member. A solid needle and a hollow needle tube are provided at the distal end of the needle fixing member. A push needle is provided at one end of the needle handle. The needle handle and the needle fixing member are connected to each other through the needle handle connector, and the push needle is located inside the hollow needle tube. The housing is equipped with a safety device, which includes a limiting post on the needle handle connector and a limiting block on one side of the needle handle connector. The limiting block is provided with an arc-shaped groove that matches the limiting post, and a guide post is provided on the limiting block. The housing is also provided with a guide groove that matches the guide post. A suture assembly, comprising an outer tube, a suture arm, a suture lead, a suture puller, a needle sheath, a bridging suture, a needle tip, and a suture thread; The thread foot is located in the distal groove of the sewing arm. The middle of the thread foot has a first slot for placing the thread puller. The thread foot is connected to the wrench through the thread puller and the internal connecting mechanism. The needle sleeve has a top end, a bottom end, and a through hole that passes through both ends. The through hole is used to insert the bridge thread. The bottom end is one end connected to the end of the bridge thread. One or more pressure plates that can be pressed into the through hole are provided on the side wall of the needle sleeve near the top end. The left and right ends of the thread foot each have a through second slot. Each second slot has a needle sleeve in its needle sleeve placement area. The two needle sleeves are connected to each other by a bridging thread. The far end of the needle sleeve placement area is connected to the needle sleeve outlet hole to form an inward bottom step. The ends of the two needle sleeves connected to the bridging thread face the needle sleeve outlet hole of the thread foot. The bridging thread on the needle sleeve that is connected to the solid needle passes through the bottom step and wraps back to the thread foot. It then passes through the bridging thread hanging hole on the sewing arm and the needle sleeve outlet hole at the other end of the thread foot, and finally connects with the needle sleeve at the other end of the thread foot. The suture is connected to the distal end of the solid needle via a pre-made fisherman's knot. The needle tip is placed on the head end of the hollow needle tube. The end of the suture away from the solid needle is connected to the needle tip, and the suture at the tail of the needle tip emerges from a groove on the side of the distal end of the hollow needle tube. The distal end of the needle tip has a head and neck with a structure similar to the distal end of the solid needle. The tail end of the needle tip is inserted into the hollow needle tube.

2. The vascular suture device according to claim 1, characterized in that, The needle sheath is made of metal, with an outer diameter of 0.4-0.6 mm, a wall thickness of 0.03 mm-0.08 mm, and a height of 1 mm-1.5 mm. The shape of the pressure plate is rectangular, trapezoidal, or triangular, with a conical or cylindrical bottom and a cylindrical top.

3. The vascular suture device according to claim 1, characterized in that, The bridging wire is made of polytetrafluoroethylene and has a diameter of 0.2-0.5mm. The end of the bridging wire inside the needle sheath is a tight, thick end with a length of 0.2-0.5mm. The needle sheath and the bridging wire are connected by stamping, heating, or barbing. The wire leads are made of plastic.

4. The vascular suture device according to claim 1, characterized in that, The needle sheath placement area is cylindrical or V-groove shaped, and the proximal end of the needle sheath placement area is connected to a guide slope, which is an opening that widens towards the proximal end.

5. The vascular suture device according to claim 1, characterized in that, The diameter of the needle sleeve outlet hole is smaller than the outer diameter of the needle sleeve, and it is cylindrical or V-groove shaped.

6. The vascular suture device according to claim 1, characterized in that, The tail of the needle is connected to the suture by adhesive, heat fusion, or riveting.

7. The vascular suture device according to claim 1, characterized in that, The vascular suture device also includes an assembly assembly for assembling solid needles and hollow needle tubes onto a needle fixation component, and simultaneously detecting whether the length and diameter of the solid needles and hollow needle tubes are up to standard. The assembly includes a positioning plate, on which two elastic connectors for fixing the needle handle connector are symmetrically arranged. Two placement platforms are arranged on the positioning plate along the same straight line. Each of the two placement platforms is provided with a V-shaped placement groove that matches the solid needle and the hollow needle tube. Two electric push rods are also symmetrically arranged on the positioning plate. Each of the telescopic ends of the two electric push rods is provided with a push plate. A first distance detector is provided between the two placement platforms. The upper surface of the first distance detector is flush with the bottom of the V-shaped placement groove, and is used to detect the distance between the solid needle and the hollow needle tube and the bottom of the V-shaped placement groove. A second distance detector is provided on each side of the first distance detector, and the two second distance detectors are used to detect the distance between the two push plates respectively.

8. The vascular suture device according to claim 7, characterized in that, It also includes an evaluation system for assessing the quality of both solid and hollow needle tubes, including: The information acquisition module is used to acquire the length and diameter information of the solid needle and the hollow needle tube, which are denoted as Cs, Ck, Ds and Dk respectively; The storage module is used to store the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube obtained by the information acquisition module. The processing module is used to retrieve the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube from the storage module, and to evaluate the quality of the vascular suture device based on these four information.

9. The vascular suture device according to claim 8, characterized in that, The specific processing method of the processing module is as follows: S1. Based on the length information Cs of the solid needle, the length information Ck of the hollow needle tube, the diameter information Ds of the solid needle, and the diameter information Dk of the hollow needle tube, obtain the length deviation value of the solid needle, the diameter deviation value of the solid needle, the length deviation value of the hollow needle, and the diameter deviation value of the hollow needle. S2. The obtained solid needle length deviation value, solid needle diameter deviation value, hollow needle tube length deviation value, and hollow needle tube diameter deviation value are compared with the preset solid needle length deviation threshold, solid needle diameter deviation threshold, hollow needle tube length deviation threshold, and hollow needle tube diameter deviation threshold. If any one of them is not within the corresponding threshold, it indicates that the vascular suture device is unqualified. S3. After dimensionless processing of the length deviation value of the solid needle, the diameter deviation value of the solid needle, the length deviation value of the hollow needle tube, and the diameter deviation value of the hollow needle tube, correlation is performed to form evaluation condition coefficients. The obtained evaluation condition coefficients are compared with preset condition coefficient thresholds. If they exceed the condition coefficient thresholds, it indicates that the vascular suture device is unqualified. The correlation model of the evaluation condition coefficients is expressed as follows: in, To evaluate the condition coefficient, The quality assessment coefficient for solid needles. This is the quality assessment coefficient for hollow syringes. This is the length deviation value of the solid needle. This is the diameter deviation value of the solid needle. This is the length deviation value of the hollow needle tube. This represents the diameter deviation value of the hollow needle tube. The weight value of the quality assessment coefficient for solid needles. This represents the weighted value of the quality assessment coefficient for hollow syringes. The influencing factor of the solid needle length deviation value. The influencing factor of the solid needle diameter deviation value. The influencing factor of the length deviation value of the hollow needle tube. The influencing factor for the diameter deviation of the hollow needle tube is 0. , , + =1,0 0 , + =1, , , + =1.

Images