Blood vessel suturing device

Abstract

The invention is suitable for the technical field of medical instruments, and provides a blood vessel suturing device which comprises a needle handle assembly, a shell, a wrench, a marking cavity, a suturing assembly and a sheathing canal assembly. The needle handle assembly comprises a needle handle, a needle handle connecting piece and a needle fixing piece, a solid needle and a hollow needle tube are arranged at the far end of the needle fixing piece, and a push needle is arranged at one end of the needle handle; a safety device is arranged in the shell, the safety device comprises a limiting column and a limiting block, an arc-shaped groove is formed in the limiting block, a guide column is arranged on the limiting block, and a guide inclined groove is formed in the shell; the sewing assembly comprises an outer tube, a sewing thread arm, a thread foot, a thread foot pull thread, a needle sleeve, a gap bridge thread, a needle head and a sewing thread. The device can solve the hemostasis problem after femoral artery puncture, meanwhile can prevent a user from misoperation in the using process, and is convenient to operate and high in safety.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a blood vessel suturing device. Background Art

[0002] Interventional surgery is the preferred treatment for cardiovascular diseases such as hemangioma, vascular stenosis and acute myocardial infarction in recent years. With its advantages of low trauma, high efficiency, precise and safe treatment, interventional surgery has become the third largest clinical treatment method after surgical and internal medicine treatment. Interventional surgery is inseparable from vascular puncture, among which femoral artery puncture is not only the classic path for coronary intervention, but also occupies 90% of the puncture routes in peripheral interventional surgery. Hemostasis after femoral artery puncture has always been a problem that troubles clinical physicians. The traditional hemostasis method is manual hemostasis, which requires manual pressure on the puncture point for up to 25 minutes, and the patient needs to stay in bed for a long time after hemostasis. It is not only time-consuming and laborious for medical staff, but also inconvenient for some patients who cannot lie flat for a long time. Therefore, it is urgent to provide a hemostatic device with significant hemostasis effect, safe and reliable vascular closure method, larger puncture port trial range, and postoperative remedial.

[0003] Vascular suturing devices are common medical devices used for suturing vascular punctures in the prior art. However, existing vascular suturing devices do not have safety devices, and users often pull out the needle handle assembly from the vascular suturing device directly without connecting the needle cover due to incorrect operation steps during operation, resulting in the entire device being scrapped. Summary of the invention

[0004] The purpose of the embodiments of the present invention is to provide a blood vessel suturing device, aiming to solve the problems raised in the above-mentioned background technology.

[0005] The embodiment of the present invention is implemented as follows: a blood vessel suturing device includes a needle handle assembly, a housing, a wrench, a marking chamber, a suturing assembly, and a sheath assembly;

[0006] The needle handle assembly is installed in the housing, and includes a needle handle, a needle handle connector and a needle fixing member. A solid needle and a hollow needle tube are arranged at the distal end of the needle fixing member, and a push needle is arranged 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 in the hollow needle tube.

[0007] A safety device is arranged inside the shell, and the safety device comprises a limit post arranged on the needle handle connecting piece, and a limit block arranged on one side of the needle handle connecting piece, the limit block is provided with an arc groove matching with the limit post, the limit block is provided with a guide post, and the shell is provided with a guide inclined groove matching with the guide post;

[0008] A suturing assembly, comprising an outer tube, a suture arm, a suture foot, a suture foot pull line, a needle sleeve, a bridge line, a needle and a suture; wherein:

[0009] The thread foot is located in the distal groove of the suture arm, and the middle part of the thread foot has a first slot for placing the thread foot pull line, and the thread foot is connected to the wrench through the thread foot pull line and the internal connection mechanism; the needle sleeve has a top end, a bottom end and a through hole running through both ends, the through hole is used to insert the bridge line, the bottom end is an end connected to the end of the bridge line, and one or more pressing sheets that can be pressed into the through hole are arranged on the side wall of the needle sleeve near the top end;

[0010] The left and right ends of the stitch foot are respectively provided with a through second card slot, and a needle sleeve is respectively installed in the needle sleeve placement area of ​​each second card slot, and the two needle sleeves are connected to each other through a bridge line, and the distal end of the needle sleeve placement area is connected to the needle sleeve outlet hole to form an inwardly retracted bottom step, and one end of the two needle sleeves connected to the bridge line faces the needle sleeve outlet hole of the stitch foot, and the bridge line on the needle sleeve connected to the solid needle passes through the bottom step and goes back to the stitch foot, and passes through the bridge line hanging hole on the suture arm and the needle sleeve outlet hole at the other end of the stitch foot, and finally connects with the needle sleeve at the other end of the stitch foot;

[0011] The suture is connected to the distal end of the solid needle through a premade fisherman's knot, the needle 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, and the suture at the tail of the needle passes through the groove on the side of the distal end of the hollow needle tube, the distal end of the needle has a head and neck with a similar structure to the distal end of the solid needle, and the tail end of the needle is inserted into the hollow needle tube.

[0012] According to a further technical solution, the needle sleeve is generally made of metal, and has 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] According to a further technical solution, the shape of the pressing sheet may be a rectangle, a trapezoid, a triangle or any other shape.

[0014] According to a further technical solution, the bottom end may be conical or straight-cylindrical, and the top end is generally straight-cylindrical.

[0015] In a further technical solution, the bridge wire is generally made of polytetrafluoroethylene material, or other materials, with a diameter of about 0.2-0.5 mm. The end of the bridge wire inside the needle sleeve is generally a tight thick head, and the length of the thick head is generally 0.2-0.5 mm. The needle sleeve and the bridge wire can be connected by stamping, heating, barbs or other methods.

[0016] According to a further technical solution, the molding is generally made of plastic.

[0017] Further technical solution: The needle sleeve placement area can be cylindrical, V-groove or other shapes. The proximal end of the needle sleeve placement area is connected to the guiding inclined plane, and the guiding inclined plane is generally an opening that expands towards the proximal end, which can be conical or other shapes, used to increase the allowable range of the docking between the needle and the needle sleeve and improve the docking accuracy between the needle and the needle sleeve.

[0018] Further technical solution: The diameter of the needle sleeve outlet hole is usually smaller than the outer diameter of the needle sleeve, and it can be cylindrical, V-groove-shaped or other shapes.

[0019] Further technical solution: The tail of the needle head and the suture can be connected by gluing, hot melting, riveting or other means.

[0020] Further technical solution: The blood vessel suture device further includes an assembly component, which is used to assemble the solid needle and the hollow needle tube onto the needle fixing piece and synchronously detect whether the lengths and diameters of the solid needle and the hollow needle tube are qualified;

[0021] The assembly component includes a positioning plate, on which two elastic connectors for fixing the needle handle connectors are symmetrically arranged. Along the same straight line on the positioning plate, two placement platforms are arranged, and V-shaped placement grooves matching the solid needle and the hollow needle tube are arranged on both of the two placement platforms. Two electric push rods are also symmetrically arranged on the positioning plate, and push plates are arranged at the telescopic ends of the two electric push rods;

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

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

[0024] Further technical solution: It further includes an evaluation system for evaluating the quality of the solid needle and the hollow needle tube, including:

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

[0026] A storage module, which 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] A 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 evaluate the quality of the blood vessel suture device based on these four pieces of information. Specifically:

[0028] S1. 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 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;

[0029] S2. Compare the obtained 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 with the preset length deviation threshold of the solid needle, the diameter deviation threshold of the solid needle, the length deviation threshold of the hollow needle tube, and the diameter deviation threshold of the hollow needle tube. If any one of them is not within the corresponding threshold, it indicates that this set of blood vessel suture devices 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, correlate them to form an evaluation condition coefficient. Compare the obtained evaluation condition coefficient with the preset condition coefficient threshold. If it exceeds the condition coefficient threshold, it indicates that this set of blood vessel suture devices is unqualified. The correlation model of the evaluation condition coefficient is expressed as:

[0031]

[0032] where PG is the evaluation condition coefficient, S X is the quality evaluation coefficient of the solid needle, K X is the quality evaluation coefficient of the hollow needle tube, S C is the length deviation value of the solid needle, S D is the diameter deviation value of the solid needle, K C is the length deviation value of the hollow needle tube, is the diameter deviation value of the hollow needle tube, α is the weight value of the quality evaluation coefficient of the solid needle, β is the weight value of the quality evaluation coefficient of the hollow needle tube, γ is the influence factor of the length deviation value of the solid needle, δ is the influence factor of the diameter deviation value of the solid needle, ε is the influence factor of the length deviation value of the hollow needle tube, θ is the influence factor of the diameter deviation value of the hollow needle tube, 0 ≤ α ≤ 1, 0 ≤ β ≤ 1, α + β = 1, 0 ≤ γ ≤ 1, 0 ≤ δ ≤ 1, γ + δ = 1, 0 ≤ ε ≤ 1, 0 ≤ θ ≤ 1, ε + θ = 1.

[0033] The beneficial effects of the present invention are:

[0034] An angiosuture device provided by an embodiment of the present invention, after the sheath tube assembly of the angiosuture enters the blood vessel lumen, manipulates the wrench to unfold the wire feet to abut against the blood vessel walls on both sides of the puncture point; pushes the needle handle to connect the solid needle and the needle tip to the two needle sleeves as a whole respectively, then pulls out the needle to make the suture thread pass through the pre-set fisherman's knot, retracts the wire feet, removes the angiosuture, and finally pushes the knot, locks the knot and cuts the thread of the suture thread remaining on both sides of the puncture point of the blood vessel wall. At the same time, when operating to push the needle handle to connect the solid needle and the needle tip to the two needle sleeves as a whole respectively, the limit block in the safety device also automatically advances in the direction of the connection between the needle tip and the needle sleeve according to the fixed sliding track. When the needle tip and the needle sleeve are connected, the limit block runs to the position where the anti-retreat is automatically released. At this time, the limit block will release the limit on the limit post, thereby releasing the anti-retreat safety. The method of realizing suture by using an angiosuture mechanism with a safety device solves the hemostasis problem after femoral artery puncture, and at the same time can prevent the wrong operation of the user from pulling out the needle handle assembly before connecting it with the needle sleeve. The operation is convenient and the safety is high. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 is a schematic structural diagram of an angiosuture device provided by an embodiment of the present invention;

[0036] Figure 2 is a schematic structural diagram of a needle handle assembly in an angiosuture device provided by an embodiment of the present invention;

[0037] Figure 3 is a schematic structural diagram of a part of an angiosuture device provided by an embodiment of the present invention;

[0038] Figure 4 is a partial cross-sectional view of an angiosuture device provided by an embodiment of the present invention;

[0039] Figure 5 is Figure 4 a sectional view taken along the line A-A of

[0040] Figure 6 is Figure 5 an enlarged view at B in

[0041] Figure 7 is a schematic structural diagram of a limit block in an angiosuture device provided by an embodiment of the present invention;

[0042] Figure 8 is a schematic structural diagram of a suture assembly in an angiosuture device provided by an embodiment of the present invention;

[0043] Figure 9 is a schematic structural diagram of a needle sleeve in an angiosuture device provided by an embodiment of the present invention;

[0044] Figure 10Schematic structural diagram of a vascular suture device provided by an embodiment of the present invention during docking;

[0045] Figure 11 Schematic structural diagram of the cooperation between a needle and a hollow needle tube in a vascular suture device provided by an embodiment of the present invention;

[0046] Figure 12 Schematic structural diagram of an assembly component in a vascular suture device provided by an embodiment of the present invention;

[0047] Figure 13 Partial structural diagram of an assembly component in a vascular suture device provided by an embodiment of the present invention.

[0048] In the drawings: needle handle assembly 1; needle handle 11; needle pusher 111; needle handle connecting piece 12; needle fixing piece 13; solid needle 131; hollow needle tube 132; head end 1321; groove 1322; outer shell 2; safety device 21; limit post 211; limit block 222; guide post 223; guide inclined groove 224; wrench 3; marking cavity 4; suture assembly 5; outer tube 51; suture arm 52; distal groove 521; overpass wire hanging hole 522; wire foot 53; first card slot 531; second card slot 532; needle sleeve placement area 5321; guide inclined plane 5322; needle sleeve outlet hole 5323; side groove 5324; wire foot pulling wire 54; needle sleeve 55; top end 551; bottom end 552; pressing piece 553; overpass wire 56; needle head 57; suture 58; fisherman's knot 581; sheath tube assembly 6; assembly component 7; positioning plate 71; elastic connecting piece 72; side plate 721; clamping plate 722; sliding rod 723; spring 724; placement table 73; V-shaped placement groove 731; first distance detector 74; electric push rod 75; push plate 76; second distance detector 77. Detailed implementation manners

[0049] In order to make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present 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 only used to explain the present invention and are not used to limit the present invention.

[0050] The specific implementation of the present invention will be described in detail below with reference to specific embodiments.

[0051] As Figure 1-11 shown, a vascular suture device provided by an embodiment of the present invention includes a needle handle assembly 1, an outer shell 2, a wrench 3, a marking cavity 4, a suture assembly 5, and a sheath tube assembly 6;

[0052] The needle handle assembly 1 is installed in the housing 2. The needle handle assembly 1 includes a needle handle 11, a needle handle connecting piece 12, and a needle fixing piece 13. A solid needle 131 and a hollow needle tube 132 are provided at the distal end of the needle fixing piece 13 (the end of the needle fixing piece 13 away from the needle handle connecting piece 12 is defined as the distal end). A needle pusher 111 is provided at one end of the needle handle 11. The needle handle 11 and the needle fixing piece 13 are connected together through the needle handle connecting piece 12, and the needle pusher 111 is located inside the hollow needle tube 132;

[0053] An insurance device 21 is provided inside the housing 2. The insurance device 21 includes a limit post 211 provided on the needle handle connecting piece 12, and a limit block 222 provided on one side of the needle handle connecting piece 12. An arc-shaped groove matching the limit post 211 is provided on the limit block 222. A guide post 223 is provided on the limit block 222, and a guide inclined groove 224 matching the guide post 223 is provided in the housing 2;

[0054] The suture assembly 5 includes an outer tube 51, a suture arm 52, a stitch 53, a stitch pulling wire 54, a needle sleeve 55, a cross-over wire 56, a needle tip 57, and a suture 58. The stitch 53 is located in the distal groove 521 of the suture arm 52. A first card slot 531 for placing the stitch pulling wire 54 is provided in the middle of the stitch 53. The stitch 53 is connected to the wrench 3 through the stitch pulling wire 54 and an internal connection mechanism (the connection mechanism in the prior art can be adopted here, and will not be described in detail here). By rotating the wrench 3, the opening and closing of the stitch 53 can be realized;

[0055] The needle sleeve 55 has a top end 551, a bottom end 552, and a through hole penetrating both ends. The through hole is used for threading the cross-over wire 56. The bottom end 552 is the end for connecting the end of the cross-over wire. One or more pressing pieces 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;

[0056] Both ends of the cross-over wire 56 are respectively connected to the bottom end 552 of a needle sleeve 55;

[0057] The left and right ends of the thread foot 53 are respectively provided with a through second clamping groove 532, the middle part of the second clamping groove 532 is a needle sleeve placement area 5321 for accommodating the needle sleeve 55, and the distal end of the needle sleeve placement area 5321 is connected to the needle sleeve outlet hole 5323 to form an inwardly retracted bottom step. The second clamping groove 532 has a lateral groove 5324 that longitudinally penetrates the thread foot and opens toward the outer sides of the left and right ends of the thread foot. The lateral groove 5324 is used to provide deformation of the thread foot to expand outward when the needle sleeve is pushed out of the thread foot after the needle and the needle sleeve are connected, so that the needle sleeve 55 can be smoothly pushed out of the thread foot. Two needle sleeves 55 connected by a bridge line 56 are respectively placed in the needle sleeve placement area 5321, and one end of the two needle sleeves 55 connected to the bridge line 56 is facing the needle sleeve outlet hole 5323 of the stitch foot 53. The bridge line 56 on the needle sleeve 55 connected to the solid needle 131 passes through the bottom step and wraps around to the stitch foot 53, and passes through the bridge line hanging hole 522 on the suture arm 52 and the needle sleeve outlet hole 5323 at the other end of the stitch foot 53, and finally connects with the needle sleeve 55 at the other end of the stitch foot 53 (the needle sleeve 55 is used to connect the needle head 57).

[0058] The suture 58 is connected to the distal end of the solid needle 131 through a prefabricated fisherman's knot 581. When suturing, the puncture can be sutured and knotted by passing through the prefabricated fisherman's knot 581 and tightening it. One end of the fisherman's knot 581 extends through the instrument body to the proximal end of the housing 2; the needle 57 is placed on the head end 1321 of the hollow needle tube 132, and 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 side of the distal end of the hollow needle tube 132. The distal end of 7 has a head and neck with a similar structure 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, which 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, and the push pin 111 in the hollow needle tube 132 can push the needle 57 off the hollow needle tube 132. The distal end 1111 of the push pin 111 can be flat, oblique or any other shape.

[0059] In an embodiment of the present invention, when performing a vascular suture operation, the device is conveyed along the guide wire until the guide wire outlet end in the sheath assembly 6 is just above the skin line, and the guide wire is removed. The device is continued to be advanced until a clear pulsed blood flow just appears in the marking cavity 4. The device is positioned at a 45-degree angle, and the thread foot 53 is unfolded by rotating the wrench 3. The device is slowly pulled back so that the thread 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 housing 2, so that the solid needle 121 and the needle head 57 are respectively docked with the needle sleeves 55 at both ends of the thread foot 53, and the needle handle assembly 1 is pulled back until the needle handle 11 and the needle head 57 are completely removed from the device body and the suture 58 is tightened. Wrap the needle handle assembly 1 connected with the suture 58 around the quick scissor mouth on the handle to cut off the distal suture in front of the needle 57, reset the wrench 3 to close the suture foot 53, remove the vascular suturing instrument until the guide wire port moves out of the skin line, pull back the end of the suture, remove the vascular suturing device, and use the thread cutting device attached to the device to push the knot and cut the thread to complete the suturing.

[0060] like Figure 9 As shown in the figure, as a preferred embodiment of the present invention, the needle sleeve 55 is generally made of metal, the bottom end 552 can be conical or straight, the top end 551 is generally straight, and the bottom end 552 in this embodiment is conical. The outer diameter of the needle sleeve 55 is 0.4-0.6mm, the wall thickness is 0.03mm-0.08mm, and the height is 1mm-1.5mm. The shape of the pressing sheet 553 can be rectangular, trapezoidal, triangular or any other shape.

[0061] like Figure 8 and 10 As shown, as a preferred embodiment of the present invention, the bridge wire 56 is generally made of polytetrafluoroethylene material, or other materials, with a diameter of about 0.2-0.5 mm. The end of the bridge wire 56 inside the needle sleeve 55 is generally a tight thick head, and the length of the thick head is generally 0.2-0.5 mm. The needle sleeve 55 and the bridge wire 56 can be connected by stamping, heating, barbs or other methods.

[0062] like Figure 10 As shown, as a preferred embodiment of the present invention, the thread foot 53 is generally made of plastic. The needle sleeve placement area 5321 can be cylindrical, V-groove or other shapes. The proximal end (the end close to the housing 2) of the needle sleeve placement area 5321 is connected to the guide slope 5322. The guide slope 5322 is generally an opening that expands toward the proximal end and can be conical or other shapes, which is used to increase the allowable range of the needle and the needle sleeve 55 docking and improve the docking accuracy of the needle and the needle sleeve 55.

[0063] 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.

[0064] As a preferred embodiment of the present invention, the tail of the needle 57 and the suture 58 can be connected by gluing, hot melting, riveting or other means.

[0065] Working principle: After the sheath assembly 6 of the vascular stapler enters the blood vessel lumen, the wrench 3 is manipulated to expand the wire feet 53 to abut against the blood vessel walls on both sides of the puncture point; the needle handle 11 is pushed to connect the solid needle 131 and the needle 57 to the two needle sleeves 55 respectively as a whole, then the needle is pulled out to make the suture 58 pass through the pre-set fisherman's knot 581, the wire feet 53 are retracted, the vascular stapler is removed, and finally the sutures remaining on both sides of the blood vessel wall puncture point are pushed, locked and cut. At the same time, when the needle handle 11 is pushed to connect the solid needle 131 and the needle to the two needle sleeves 55 respectively as a whole, the limit block 222 in the safety device also automatically advances in the direction of connecting the needle 57 and the needle sleeve 55 according to the fixed sliding track (the guide post 223 slides along the guide chute 224). When the needle 57 and the needle sleeve 55 are connected, the limit block 222 runs to the automatic release position to prevent backward movement. At this time, the limit block 222 will release the limit on the limit post 211, thus releasing the anti-backward safety.

[0066] As Figure 12 and 13 shown, as a preferred embodiment of the present invention, the vascular suturing device further includes an assembly component 7, and the assembly component 7 is used to assemble the solid needle 131 and the hollow needle tube 132 onto the needle fixing member 13, and synchronously detect whether the lengths and diameters of the solid needle 131 and the hollow needle tube 132 are qualified;

[0067] The assembly component 7 includes a positioning plate 71, and two elastic connectors 72 for fixing the needle handle connectors 12 are symmetrically arranged on the positioning plate 71. Two placement platforms 73 are arranged on the positioning plate 71 along the same straight line. V-shaped placement grooves 731 matching the solid needle 131 and the hollow needle tube 132 are arranged on both of the two placement platforms 73. Two electric push rods 75 are also symmetrically arranged on the positioning plate 71, and push plates 76 are arranged at the telescopic ends of the two electric push rods 75;

[0068] A first distance detector 74 is arranged 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 from the bottom of the V-shaped placement groove 731;

[0069] One second distance detector 77 is arranged on each side of the first distance detector 74, and the two second distance detectors 77 are respectively used to detect the distance between the two push plates 76.

[0070] In the embodiment of the present invention, during use, first place the needle handle connector 12 on the positioning plate 71 and fix it through two elastic connectors 72. Then, place the solid needle 131 and the hollow needle tube 132 in the corresponding V-shaped placement grooves 731 respectively. Use the first distance detector 74 to detect the distances between the bottom ends of the solid needle 131 and the hollow needle tube 132 and the bottom of the V-shaped placement groove 731 respectively, so as to determine whether the diameters of the solid needle 131 and the hollow needle tube 132 are qualified. After passing the detection, control the electric push rod 75 to contract, so as to drive the solid needle 131 and the hollow needle tube 132 to move towards the needle fixing member 13 through the push plate 76, so as to insert the solid needle 131 and the hollow needle tube 132 into the needle fixing member 13, and synchronously use the second distance detector 77 to detect the distance between them and the push plate 76 at this time, so as to determine whether the lengths of the solid needle 131 and the hollow needle tube 132 are qualified.

[0071] As Figure 12 shown, as a preferred embodiment of the present invention, the elastic connector 72 includes a side plate 721 installed 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 penetrates the side plate 721 and can slide. A plurality of springs 724 are connected between the side plate 721 and the clamping plate 722;

[0072] It further includes an evaluation system for evaluating the quality of the solid needle 131 and the hollow needle tube 132, including:

[0073] An information acquisition module for obtaining the length information and diameter information of the solid needle 131 and the hollow needle tube 132 respectively, denoted as Cs, Ck, Ds, and D;

[0074] A storage module for storing 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;

[0075] A processing module for retrieving 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 stored in the storage module, and evaluating the quality of the blood vessel suture device based on the four, specifically:

[0076] S1. According to 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;

[0077] S2. Compare the obtained 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 tube 132, and the diameter deviation value of the hollow needle tube 132 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 respectively. If any one of them is not within the corresponding threshold, it indicates that this set of blood vessel suture devices is unqualified;

[0078] S3. After dimensionless processing of 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 tube 132, and the diameter deviation value of the hollow needle tube 132, correlate them to form an evaluation condition coefficient. Compare the obtained evaluation condition coefficient with the preset condition coefficient threshold. If it exceeds the condition coefficient threshold, it indicates that this set of blood vessel suture devices is unqualified. The correlation model of the evaluation condition coefficient is expressed as:

[0079]

[0080] where PG is the evaluation condition coefficient, S X is the quality evaluation coefficient of the solid needle 131, K X is the quality evaluation coefficient of the hollow needle tube 132, S C is the length deviation value of the solid needle 131, S D is the diameter deviation value of the solid needle 131, K C is the length deviation value of the hollow needle tube 132, is the diameter deviation value of the hollow needle tube 132, α is the weight value of the quality evaluation coefficient of the solid needle 131, β is the weight value of the quality evaluation coefficient of the hollow needle tube 132, γ is the influence factor of the length deviation value of the solid needle 131, δ is the influence factor of the diameter deviation value of the solid needle 131, ε is the influence factor of the length deviation value of the hollow needle tube 132, θ is the influence factor of the diameter deviation value of the hollow needle tube 132, 0 ≤ α ≤ 1, 0 ≤ β ≤ 1, α + β = 1, 0 ≤ γ ≤ 1, 0 ≤ δ ≤ 1, γ + δ = 1, 0 ≤ ε ≤ 1, 0 ≤ θ ≤ 1, ε + θ = 1.

[0081] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A vascular suturing device, characterized in that: It includes a needle handle assembly, a housing, a wrench, a marking cavity, a suture assembly, and a sheath assembly; The needle handle assembly is installed in the housing, and includes a needle handle, a needle handle connector and a needle fixing member. A solid needle and a hollow needle tube are arranged at the distal end of the needle fixing member, and a push needle is arranged 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 in the hollow needle tube. A safety device is arranged inside the shell, and the safety device comprises a limit column arranged on the needle handle connecting piece, and a limit block arranged on one side of the needle handle connecting piece, the limit block is provided with an arc groove matching with the limit column, the limit block is provided with a guide column, and the shell is provided with a guide inclined groove matching with the guide column; A suturing assembly, the suturing assembly comprising an outer tube, a suture arm, a suture foot, a suture foot pull line, a needle sleeve, a bridge line, a needle and a suture; The thread foot is located in the distal groove of the suture arm, and the middle part of the thread foot has a first slot for placing the thread foot pull line, and the thread foot is connected to the wrench through the thread foot pull line and the internal connection mechanism; the needle sleeve has a top end, a bottom end and a through hole running through both ends, the through hole is used to insert the bridge line, the bottom end is an end connected to the end of the bridge line, and one or more pressing sheets that can be pressed into the through hole are arranged on the side wall of the needle sleeve near the top end; The left and right ends of the stitch foot are respectively provided with a through second card slot, and a needle sleeve is respectively installed in the needle sleeve placement area of ​​each second card slot, and the two needle sleeves are connected to each other through a bridge line, and the distal end of the needle sleeve placement area is connected to the needle sleeve outlet hole to form an inwardly retracted bottom step, and one end of the two needle sleeves connected to the bridge line faces the needle sleeve outlet hole of the stitch foot, and the bridge line on the needle sleeve connected to the solid needle passes through the bottom step and goes back to the stitch foot, and passes through the bridge line hanging hole on the suture arm and the needle sleeve outlet hole at the other end of the stitch foot, and finally connects with the needle sleeve at the other end of the stitch foot; The suture is connected to the distal end of the solid needle through a premade fisherman's knot, the needle 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, and the suture at the tail of the needle passes through the groove on the side of the distal end of the hollow needle tube, the distal end of the needle has a head and neck with a similar structure to the distal end of the solid needle, and the tail end of the needle is inserted into the hollow needle tube.

2. A vascular suturing device according to claim 1, characterized in that: The needle sleeve is made of metal, with an outer diameter of 0.4-0.6mm, a wall thickness of 0.03mm-0.08mm, and a height of 1mm-1.5mm. The shape of the pressing sheet is rectangular, trapezoidal or triangular, the bottom end is conical or straight, and the top end is straight.

3. The vascular suturing device according to claim 1, characterized in that: The bridge wire is made of polytetrafluoroethylene material and has a diameter of 0.2-0.5mm; the end of the bridge wire inside the needle sleeve is a tight thick head with a length of 0.2-0.5mm; the needle sleeve and the bridge wire are connected by stamping, heating or barbs, and the wire feet are made of plastic.

4. A vascular suturing device according to claim 1, characterized in that: The needle sleeve placement area is cylindrical or V-groove-shaped, and the proximal end of the needle sleeve placement area is connected to the guiding inclined surface, and the guiding inclined surface is an opening that expands toward the proximal end.

5. A vascular suturing 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 is cylindrical or V-groove shaped.

6. A vascular suturing device according to claim 1, characterized in that: The tail of the needle is connected to the suture by gluing, hot melting or riveting.

7. A vascular suturing device according to claim 1, characterized in that: The blood vessel suturing device also includes an assembly component, which is used to assemble the solid needle and the hollow needle tube to the needle fixing member, and simultaneously detect whether the length and diameter of the solid needle and the hollow needle tube are qualified; The assembly component 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 same straight line along the upper edge of the positioning plate, and both of the two placement platforms are provided with V-shaped placement grooves matching the solid needle and the hollow needle tube, and two electric push rods are also symmetrically arranged on the positioning plate, and push plates are arranged at the telescopic ends of the two electric push rods; A first distance detector is arranged between the two placement tables, 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 respectively arranged on both sides of the first distance detector, and the two second distance detectors are respectively used to detect the distance between the two push plates.

8. A blood vessel suturing device according to claim 7, characterized in that: Also included is an evaluation system for assessing the quality of solid and hollow needle barrels, including: The information acquisition module is used to obtain the length information and diameter information of the solid needle and the hollow needle tube, which are recorded as Cs, Ck, Ds and Dk respectively; A storage module, used for storing 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 acquired 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 evaluate the quality of the vascular suturing device based on the four.

9. A blood vessel suturing device according to claim 8, characterized in that: The specific processing method of the processing module is: S1. Obtaining 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 according to 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; S2, comparing 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 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 of them is not within the corresponding threshold, it indicates that the vascular suturing device is unqualified; S3, 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 are dimensionlessly processed and then associated to form an evaluation condition coefficient, and the obtained evaluation condition coefficient is compared with a preset condition coefficient threshold value. If it exceeds the condition coefficient threshold value, it indicates that the vascular suturing device is unqualified. The association model of the evaluation condition coefficient is expressed as: Among them, PG is the evaluation condition coefficient, S X is the quality assessment coefficient of the solid needle, K X is the quality assessment coefficient of the hollow needle tube, S C is the length deviation of the solid needle, S D is the diameter deviation of the solid needle, K C is the length deviation value of the hollow needle tube, is the diameter deviation value of the hollow needle tube, α is the weight value of the quality assessment coefficient of the solid needle, β is the weight value of the quality assessment coefficient of the hollow needle tube, γ is the influencing factor of the length deviation value of the solid needle, δ is the influencing factor of the diameter deviation value of the solid needle, ε is the influencing factor of the length deviation value of the hollow needle tube, θ is the influencing factor of the diameter deviation value of the hollow needle tube, 0≤α≤1, ≤β≤1, α+β=1, 0≤γ≤1, 0≤δ≤1, γ+δ=1, 0≤ε≤1, 0≤θ≤1, ε+θ=1.

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