Vascular suture device and vascular suture system

Abstract

The present invention relates to a vascular suturing device and a vascular suturing system. The vascular suturing device includes a thread foot assembly, a push handle assembly, and a feedback line. The thread foot assembly includes a thread foot body, and connecting sleeves are provided on both sides of the thread foot body; the wall of the connecting sleeve is provided with a window and a baffle, and the distal outer side of the baffle is provided with a cutting portion, and the cutting portion is opposite to the inner wall of the connecting sleeve; a connecting needle is provided at the distal end of the push handle assembly, and the connecting needle can be engaged with the connecting sleeve; the distal end of the feedback line is provided with a bulge, which is arranged in the connecting sleeve, and the proximal end of the feedback line extends out of the window; the connecting needle can penetrate the connecting sleeve and radially squeeze the baffle so that the cutting portion is embedded in the window to cut the feedback line. Through the present invention, when the doctor presses down the push handle assembly, he can judge whether the front needle and the rear needle are both inserted into the corresponding connecting sleeve by pulling the feedback line at the proximal end of the suturing device body, thereby improving the success rate of vascular suturing.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a vascular suturing device and a vascular suturing system suitable for post-operative cardiovascular interventional therapy. Background Art

[0002] With the rapid development of medical interventional technology, it is widely used in various types of interventional surgeries clinically due to its characteristics of less trauma, shorter bed rest time for patients, and faster recovery. Since interventional surgeries mostly involve making a minimally invasive incision on the human body's arteries and veins, allowing interventional instruments to pass through the blood vessels into the patient's diseased area for surgical treatment, Abbott's ProGlide vascular suture device is often used to suture the incision after surgery. During use, the ProGlide vascular suture device needs to press down the push handle so that the front and rear needles are inserted into the corresponding sleeves respectively, and then the push handle is pulled out to drive the trajectory through the fisherman's knot, thereby achieving the purpose of suturing the vascular incision. However, when pressing down the push handle, since it is impossible to directly see the contact between the front and rear needles and the sleeve, continuing the suturing operation may cause the vascular suture to fail.

[0003] Based on the above reasons, how to design a vascular suture device with an operation feedback function has become a problem that needs to be solved at present. Summary of the Invention

[0004] The invention discloses a vascular suturing device and a vascular suturing system, aiming to solve the technical problems existing in the prior art.

[0005] The present invention adopts the following technical solutions:

[0006] In one aspect, the present application discloses a vascular suturing device, comprising:

[0007] - a molding assembly, the molding assembly comprising a molding body, with connecting sleeves provided on both sides of the molding body;

[0008] The wall of the connecting sleeve is provided with a window and a baffle, the baffle extending radially inward from the proximal end of the window and toward the distal end, and a cutting portion is provided on the outer side of the distal end of the baffle, the cutting portion being opposite to the inner wall of the connecting sleeve;

[0009] - a push handle assembly, wherein a connecting needle is provided at the distal end of the push handle assembly and the connecting needle can be engaged with the connecting sleeve;

[0010] - a feedback line, wherein a distal end of the feedback line is provided with a bulge, the bulge being disposed in the connecting sleeve, and a proximal end of the feedback line extending out of the window;

[0011] The connecting needle can penetrate into the connecting sleeve and radially press the blocking piece so that the cutting portion is embedded in the window to cut off the feedback line.

[0012] As a preferred technical solution, the wall of the connecting sleeve is provided with a pair of windows and baffles, and the windows and baffles are symmetrically arranged along the circumferential direction.

[0013] As a preferred technical solution, the distal end of the connecting needle includes a boss portion and a positioning recess; the boss portion is used to squeeze the baffle when passing through the connecting sleeve, and to cause the cutting portion to cut off the feedback line; the positioning recess is used to provide an accommodating space for the resetting of the baffle, and to enable the baffle to block the boss portion.

[0014] As a preferred technical solution, the maximum outer diameter of the boss portion is smaller than the inner diameter of the connecting sleeve.

[0015] As a preferred technical solution, the minimum outer diameter of the positioning recess is smaller than the minimum distance between a pair of blocking pieces.

[0016] As a preferred technical solution, the axial length of the baffle is not greater than the axial length of the window.

[0017] As a preferred technical solution, the blocking piece includes a resilient material having a shape memory function or a bias setting.

[0018] As a preferred technical solution, a pair of baffles are provided with a cutting portion at their distal ends, and each cutting portion is provided with a corresponding feedback line;

[0019] Alternatively, only one of the pair of baffles is provided with a cutting portion at its distal end, and the feedback line is only provided corresponding to the cutting portion.

[0020] As a preferred technical solution, the cutting portion is wedge-shaped and extends toward the inner wall of the connecting sleeve, and the distance between the cutting portion and the inner wall of the connecting sleeve is greater than the diameter of the feedback line.

[0021] As a preferred technical solution, the diameter of the bulge portion is greater than the distance between the cutting portion and the inner wall of the connecting sleeve.

[0022] As a preferred technical solution, the vascular suture device further includes a suture device body, a proximal tube and a distal tube arranged in sequence from the proximal end to the distal end;

[0023] The proximal end of the push handle assembly is axially penetrated in the stapler body; the distal end of the push handle assembly is penetrated in the proximal pipe fitting, and the stitch foot assembly is arranged between the proximal pipe fitting and the distal pipe fitting.

[0024] As a preferred technical solution, the connecting needle includes a front needle and a rear needle; the connecting sleeve includes a front needle connecting sleeve and a rear needle connecting sleeve; the distal ends of the front needle connecting sleeve and the rear needle connecting sleeve are connected to each other through a connecting line; the feedback line includes a front needle feedback line and a rear needle feedback line.

[0025] As a preferred technical solution, a suture knot and an axis are provided at the distal end of the front needle, and a track is provided at the distal end of the rear needle.

[0026] As a preferred technical solution, there are two front needle feedback lines and / or two rear needle feedback lines.

[0027] As a preferred technical solution, the feedback line is passed through the proximal tube and passes through the proximal end of the stapler body.

[0028] As a preferred technical solution, the suturing device body is provided with a limiting device near the position where the proximal end of the feedback line passes through, and the limiting device is used to fix the proximal end of the feedback line.

[0029] In a second aspect, the present application also provides a vascular suturing system, comprising the vascular suturing device as described in any one of the above items, and also comprising a suture adjuster.

[0030] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0031] (1) The present invention mainly provides a vascular suturing device, in which a cutting portion and a feedback line are provided in the connecting sleeves at both ends of the leg assembly, the cutting portion is provided on the outside of the baffle in the connecting sleeve, one end of the feedback line is fixed in the connecting sleeve, and the other end extends outward from the window of the connecting sleeve, extending all the way to the proximal end of the suturing device body and passing through; when the connecting needle (including the front needle and the rear needle) in the suturing device is inserted into the connecting sleeve, the baffle is subjected to radial compression, so that the cutting portion cuts off the feedback line, and the doctor can pull out the feedback line from the proximal end of the suturing device body; through this structure, the doctor can judge whether the front needle and the rear needle are both inserted into the corresponding connecting sleeve when pressing down the push handle assembly, thereby improving the success rate of vascular suturing.

[0032] (2) In a preferred embodiment, a cutting portion is provided on the baffle in each connecting sleeve, and each cutting portion corresponds to a feedback line. After pressing the push handle assembly, all the feedback lines can be pulled out only after the front needle and the rear needle are combined with the corresponding connecting sleeve, so as to further increase the accuracy and success rate of suturing. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0034] Figure 1 This is a structural diagram of an operation feedback structure in a preferred implementation manner disclosed in Example 1 of the present invention;

[0035] Figure 2 for Figure 1 Enlarged view of point A in the middle;

[0036] Figure 3This is a structural diagram of a connecting sleeve and a feedback line in a preferred implementation manner disclosed in Example 1 of the present invention;

[0037] Figure 4 A three-dimensional diagram of a vascular suturing device according to a preferred embodiment of the present invention disclosed in Example 2;

[0038] Figure 5 This is a schematic diagram of a partially exploded structure of a vascular suturing device according to a preferred embodiment of the present invention disclosed in Example 2;

[0039] Figure 6 This is a schematic diagram of a partially exploded structure of a vascular suturing device according to a preferred embodiment of the present invention disclosed in Example 2;

[0040] Figure 7 for Figure 6 A partial enlarged view of point B in the middle;

[0041] Figure 8 This is a structural diagram of a pin assembly, a feedback line, and a connecting pin in a preferred implementation manner disclosed in Example 2 of the present invention;

[0042] Figure 9 A cross-sectional view of a pin assembly, a feedback line, and a connecting pin in a preferred embodiment of the present invention disclosed in Example 2;

[0043] Description of reference numerals:

[0044] The stapler body 10, the wrench 11, the quick scissor blade 12; the push handle assembly 20, the connecting needle 21, the boss portion 211, the positioning recess 212, the front needle 22, and the rear needle 23; the suture foot assembly 30, the connecting sleeve 31, the front needle connecting sleeve 311, the rear needle connecting sleeve 312, the baffle 32, the cutting portion 321, the window 33, the connecting line 34, the suture foot body 35; the suture 40; the feedback line 50, the front needle feedback line 51, the rear needle feedback line 52; the proximal tube 60, and the distal tube 70. DETAILED DESCRIPTION

[0045] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0046] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0047] In the following embodiments, "proximal end" refers to the end closer to the operator, and "distal end" refers to the end farther from the operator.

[0048] To solve the problems existing in the prior art, an embodiment of the present application provides a vascular suture device, including a thread foot assembly 30, a push handle assembly 20 and a feedback line 50; the thread foot assembly 30 includes a thread foot body 35, and a connecting sleeve 31 is provided on both sides of the thread foot body 35; the wall of the connecting sleeve 31 is provided with a window 33 and a baffle 32, the baffle 32 extends radially inward and distally from the proximal end of the window 33, and a cutting portion 321 is provided on the outer side of the distal end of the baffle 32, and the cutting portion 321 is opposite to the inner wall of the connecting sleeve 31; a connecting needle 21 is provided at the distal end of the push handle assembly 20, and the connecting needle 21 can be snap-fitted with the connecting sleeve 31; a bulge is provided at the distal end of the feedback line 50, and the bulge is provided in the connecting sleeve 31, and the proximal end of the feedback line 50 extends out from the window 33; the connecting needle 21 can penetrate the connecting sleeve 31 and radially squeeze the baffle 32 so that the cutting portion 321 is embedded in the window 33 to cut off the feedback line 50.

[0049] Example 1

[0050] With the widespread use of interventional surgery, the ability to quickly and effectively stop bleeding after surgery has become a key factor in determining the success of the surgery. Due to the use of anticoagulants and antiplatelet drugs during surgery, doctors traditionally rely on a variety of external pressure methods to close arteries and veins, including direct pressure, sandbags, or mechanical clamps. In recent years, more and more doctors have used vascular suture devices to suture large and medium-sized blood vessels after patients' interventional surgery to promote hemostasis and rapid wound recovery. Among them, the most commonly used vascular suture device is Abbott's Proglide vascular suture device. Compared with incision and suture, it has the advantages of reducing the risk of complications, shortening patient immobilization and hospitalization time, and can be widely used in coronary intervention, radiofrequency ablation, structural heart disease, extracorporeal circulation and other cardiac-related procedures.

[0051] Although the Proglide vascular suturing device has many advantages, due to its relatively delicate structure, when its push handle assembly is pressed, the connecting needle at the distal end of the push handle assembly may not be able to accurately penetrate the connecting sleeve to engage with it. It is foreseeable that when the connecting needle and the connecting sleeve cannot be properly engaged, the sutures will not be able to cooperate with each other to suture the vascular wound, thereby causing the failure of the vascular suturing.

[0052] Based on the above reasons, this embodiment provides an operation feedback structure suitable for various vascular suturing devices that require the connecting needle 21 and the connecting sleeve 31 to be engaged with each other.

[0053] refer to Figure 1 — Figure 3The operation feedback structure includes a connecting sleeve 31, a connecting needle 21 and a feedback line 50. One end of the connecting sleeve 31 is open and the other end is closed. The connecting needle 21 can penetrate into the connecting sleeve 31 and make the two clamped. One end of the feedback line 50 is enlarged, and the other end passes through the side wall of the connecting sleeve 31 and extends outward.

[0054] Those skilled in the art should understand that the connecting sleeve 31 in this embodiment is the sleeve provided at both ends of the line foot assembly 30 of the vascular suture device, and the connecting line 34 is provided in the closed end of the sleeve, and the two ends of the connecting line 34 are respectively fixed to the two ends of the two sleeves; the connecting needle 21 is the front needle 22 and / or the rear needle 23 at the distal end of the push handle assembly 20. By pressing the push handle assembly 20, the front needle 22 and the rear needle 23 can be respectively inserted into the corresponding sleeves, the front needle 22 is inserted into the suture knot of a suture 40 (preferably a fisherman's knot), and the rear needle 23 is arranged in parallel with the other suture 40, as shown in FIG. Figure 7 .

[0055] refer to Figure 3 Preferably, the wall of the connecting sleeve 31 is provided with at least two windows 33, the two windows 33 are symmetrically distributed along the circumference of the wall, and the length direction of the window 33 is consistent with the length direction of the connecting sleeve 31; preferably, the size of the window 33 should allow the feedback line 50 to pass through it.

[0056] Preferably, a baffle 32 is provided at the proximal end of each window 33, and the baffle 32 extends radially inward and distally from the proximal end of the window 33, forming an angle of less than 90° with the barrel wall of the connecting sleeve 31; in a preferred embodiment, the size of the baffle 32 is slightly smaller than the size of the window 33, and the baffle 32 is made of shape memory metal or a biased rebound material; when the connecting needle 21 penetrates into the connecting sleeve 31, the two baffles 32 are first radially squeezed and expanded outward, and their size is smaller than the window 33 to ensure that the baffle 32 can be bent to the same curved surface as the barrel wall to facilitate the passage of the connecting needle 21, and then the baffle 32 is reset to press the distal end of the connecting needle 21 to prevent it from detaching from the connecting sleeve 31, so as to achieve a snap connection between the connecting sleeve 31 and the connecting needle 21.

[0057] In a preferred embodiment, when the baffle 32 is squeezed by the connecting needle 21 and bent to the same curved surface as the wall of the connecting sleeve 31, the inner curvature of the baffle 32 should match the curvature of the wall to ensure that a smooth channel is formed in the wall to facilitate the passage of the connecting needle 21.

[0058] In a preferred embodiment, to enhance structural integrity and strength, the baffle 32 is made of the same material as the connecting sleeve 31, or the connecting sleeve 31 is punched, laser cut, or bent to form the baffle 32. Those skilled in the art will appreciate that other processing techniques may also be used to enable the baffle 32 to achieve its bending and resetting function.

[0059] Preferably, a cutting portion 321 is provided on the outer distal end of the baffle 32. The cutting portion 321 is generally wedge-shaped or blade-shaped, and faces the inner wall of the connecting sleeve 31. In a preferred embodiment, to ensure that the baffle 32 can bend to the same curved surface as the wall of the connecting sleeve 31 when squeezed by the connecting needle 21, the axial length of the baffle 32 is slightly smaller than the axial length of the window 33. More preferably, when the baffle 32 is squeezed and deformed by the connecting needle 21, it can precisely match the dimensions of the window 33.

[0060] Matching the cutting portion 321 is the feedback line 50. The distal end of the feedback line 50 is swollen to form a bulge, and the rest is in the shape of an ordinary thin line and passes out from the window 33; preferably, the bulge can be formed by knotting the feedback line 50, or a limiting structure such as a clamp can be added; preferably, the diameter of the bulge of the feedback line 50 is larger than the distance between the cutting portion 321 and the inner wall of the connecting sleeve 31, and the diameter of the rest is smaller than the distance between the cutting portion 321 and the inner wall of the connecting sleeve 31, so as to ensure that one end of the feedback line 50 can be fixed in the connecting sleeve 31, and the rest can pass out from the window 33; more preferably, the feedback line 50 passes out from the window 33, and there is a certain gap between it and the cutting portion 321 to avoid the feedback line 50 being accidentally cut off before the connecting needle 21 is inserted into the connecting sleeve 31.

[0061] Preferably, the feedback cable 50 is provided with a slightly enlarged retaining structure after passing through the window 33, thereby preventing the feedback cable 50 from moving freely. More preferably, retaining structures are provided on both sides of the feedback cable 50 passing through the window 33 to prevent the feedback cable 50 from being cut due to its free movement. In a preferred embodiment, the retaining structure is also formed by tying the feedback cable 50 into a knot.

[0062] In a preferred embodiment, the feedback line 50 is made of a material with a certain structural strength and easy to cut, and is not made of a braided line (not easy to cut), but can be made of a material such as polyester fiber.

[0063] In another preferred embodiment, a cutting portion 321 is provided on the baffle 32 arranged on the inner wall of the connecting sleeve 31, and a feedback line 50 is provided in each window 33; when the connecting needle 21 is inserted into the connecting sleeve 31, only when both feedback lines 50 are cut off can it be proved that the connecting needle 21 is correctly engaged with the corresponding connecting sleeve 31, so as to further increase the accuracy and success rate of suturing.

[0064] like Figure 2 Preferably, the distal end of the connecting needle 21 includes a boss portion 211 and a positioning recess 212, wherein the boss portion 211 can be used to squeeze the baffles 32 on both sides when the connecting needle 21 penetrates the connecting sleeve 31, so that the distal end of the connecting needle 21 can smoothly penetrate the connecting sleeve 31, and at the same time, the cutting portion 321 at the distal end of the baffle 32 moves toward the inner wall of the connecting sleeve 31, and finally precisely cooperates with the window 33 to cut off the feedback line 50, so that the physician can pull out the feedback line 50, proving that the connecting needle 21 is correctly engaged with the connecting sleeve 31; the positioning recess 212 is used to provide a movable and accommodating space for the reset of the baffle 32. When the baffle 32 is reset, it can be stuck against the proximal end of the boss portion 211 to prevent the connecting needle 21 from falling out of the connecting sleeve 31.

[0065] In a preferred embodiment, the boss portion 211 is roughly conical, arrow-shaped or similar in shape; its distal end has a smaller diameter to facilitate insertion into the connecting sleeve 31; while the proximal end has a larger diameter and is an annular plane that can cooperate with the baffle 32 to complete the snap-on connection between the connecting needle 21 and the connecting sleeve 31.

[0066] Those skilled in the art should understand that when two feedback lines 50 are set in the connecting sleeve 31, two bulges are provided inside. At this time, the axial length of the boss portion 211 is correspondingly reduced and should be smaller than the distance from the outer bulge to the plane where the pair of baffles 32 are located.

[0067] In a preferred embodiment, the positioning recess 212 is generally conical, and the outer contour of the positioning recess 212 matches the baffle 32, ensuring that after the boss portion 211 passes through the baffle 32, the baffle 32 can be reset in the positioning recess 212, ensuring that the baffle 32 can abut the proximal end of the boss portion 211. Preferably, the minimum outer diameter of the positioning recess 212 is less than the minimum distance between a pair of baffles 32.

[0068] In this embodiment, the above-mentioned operation feedback structure can be applied to the thread foot assembly 30 of the vascular suture device. When the doctor uses the vascular suture device to suture the blood vessel, he presses the push handle assembly 20, and the connecting needle 21 at its distal end can be inserted into the connecting sleeve 31 of the thread foot assembly 30. When the connecting needle 21 is correctly engaged with the corresponding connecting sleeve 31, the cutting portion 321 in the feedback structure can cut off the feedback line 50. At this time, if the doctor can pull out the feedback line 50 from the vascular suture device, it proves that the connecting needle 21 and the thread foot assembly 30 are correctly matched. If a certain feedback line 50 cannot be pulled out from the vascular suture device, it proves that the corresponding connecting needle 21 is not inserted into the corresponding connecting sleeve 31, and the vascular suture device needs to be adjusted or replaced with a new one.

[0069] Example 2

[0070] This embodiment provides a vascular suture device, which includes the operation feedback structure described in the first embodiment. Therefore, the various features of the first embodiment are naturally inherited in this embodiment.

[0071] like Figure 4 — Figure 9 The main structure of the vascular suturing device includes a suturing device body 10, a proximal tube 60, a distal tube 70, a wire foot assembly 30, a push handle assembly 20 and a feedback line 50. The operation feedback structure in Example 1 is composed of the wire foot assembly 30, part of the structure in the push handle assembly 20 and the feedback line 50.

[0072] Preferably, the stapler body 10 is connected to the proximal tube fitting 60 and the distal tube fitting 70 in sequence, the proximal end of the push handle assembly 20 is axially inserted into the stapler body 10, the distal end of the push handle assembly 20 is inserted into the proximal tube fitting 60, and the pin assembly 30 is arranged between the proximal tube fitting 60 and the distal tube fitting 70.

[0073] Preferably, a wrench 11 is provided on the stapler body 10, and the wrench 11 is connected to the thread foot assembly 30 through a linkage. When the wrench 11 is lifted, the thread foot assembly 30 can be rotated to a certain angle; those skilled in the art should understand that the structure of the stapler body 10 in this embodiment is consistent with the structure of the Proglide vascular suture device, and the linkage and matching relationship between the stapler body 10 and the thread foot assembly 30 is also consistent with the structure in the prior art, which will not be repeated here.

[0074] refer to Figure 7 — Figure 9Preferably, the thread foot assembly 30 is roughly flat-handle-shaped, and connecting sleeves 31 are provided at both ends of the thread foot assembly 30, namely the front needle connecting sleeve 311 and the rear needle connecting sleeve 312, and the distal ends of the connecting sleeves 31 are connected by the same connecting line 34; in the initial state, the long axis direction of the thread foot assembly 30 is consistent with the long axis direction of the proximal pipe fitting 60. When the wrench 11 is lifted, the thread foot assembly 30 can be rotated clockwise by approximately 90°, so that the opening directions of the front needle connecting sleeve 311 and the rear needle connecting sleeve 312 are both facing the proximal end.

[0075] Those skilled in the art should understand that the front needle connecting sleeve 311 and the rear needle connecting sleeve 312 at both ends of the pin assembly 30 are not arranged in parallel, but at a certain angle. The specific angle setting should match the angle of the connecting needle 21 at the distal end of the push handle assembly 20, such as Figure 9 .

[0076] Preferably, two support rods are provided in the push handle assembly 20, and connecting needles 21 are provided at the distal ends of the two needle support rods, namely the front needle 22 and the rear needle 23; in the initial state, the front needle 22 and the rear needle 23 conform to the extension direction of the proximal connecting tube and are placed in the proximal connecting tube. When the push handle assembly 20 is pressed, the front needle 22 and the rear needle 23 extend toward the distal end, and the two are opened at a certain angle and are respectively clamped in the front needle connecting sleeve 311 and the rear needle connecting sleeve 312.

[0077] Preferably, the front needle 22 and a support rod are inserted into the suture knot of a suture 40 (axis), the rear needle 23 is arranged in parallel with another support rod, and the rear needle 23 is fixed to another suture 40 (track); when the push handle assembly 20 is pressed, the front needle 22 is clamped into the front needle connecting sleeve 311, and the rear needle 23 is clamped into the rear needle connecting sleeve 312. When the push handle assembly 20 is pulled out from the suture device body 10, the front needle 22 and the front needle connecting sleeve 311 drive the connecting line 34, and the connecting line 34 drives the rear needle connecting sleeve 312 and the track, so that the track can be inserted into the knot of the axis to complete the initial operation of vascular suturing.

[0078] Those skilled in the art should understand that the operation mode and the coordination mode of the various structures of the above-mentioned vascular suture device are the same as those of the Proglide vascular suture device, and will not be described in detail here.

[0079] Preferably, a feedback line 50 and a matching cutting portion 321 are provided in the front needle connecting sleeve 311 and the rear needle connecting sleeve 312. The feedback line 50 includes a front needle feedback line 51 and a rear needle feedback line 52. The two feedback lines 50 are passed through the proximal tube 60 and extend to the proximal opening of the suture device body 10 to pass through; when the front needle 22 and the rear needle 23 are respectively inserted into the front needle connecting sleeve 311 and the rear needle connecting sleeve 312, the front needle feedback line 51 and the rear needle feedback line 52 are respectively cut off by the cutting portion 321, and the doctor can respectively pull out the front needle feedback line 51 and the rear needle feedback line 52, proving that the connecting needle 21 and the thread foot assembly 30 are correctly matched. If a certain feedback line 50 cannot be pulled out from the vascular suture device, it proves that the corresponding connecting needle 21 is not inserted into the corresponding connecting sleeve 31, and a new vascular suture device needs to be adjusted or replaced.

[0080] In a preferred embodiment, two feedback lines 50 are respectively provided in the front needle connecting sleeve 311 and the rear needle connecting sleeve 312, and each feedback line 50 corresponds to a cutting portion 321 of a baffle 32. After the doctor presses the push handle assembly 20, only when the two feedback lines 50 corresponding to each connecting needle 21 can be pulled out, can it be proved that the connecting needle 21 and the thread foot assembly 30 are correctly matched. If a certain feedback line 50 cannot be pulled out, it proves that the corresponding connecting needle 21 has not been inserted or has not been fully inserted into the corresponding connecting sleeve 31, and the vascular suture device needs to be adjusted at this time.

[0081] In a preferred embodiment, the stapler body 10 is provided with a limiting device near the proximal end of the feedback line 50, which can fix the feedback line 50 and ensure that the feedback line 50 is in a tensioned state when being cut, thereby preventing the feedback line 50 from moving undesirably due to relaxation, making it difficult for the cutting portion 321 to cut it. Optionally, the limiting device is configured as a clip-like structure, a winding plate-like structure, or other other structures capable of fixing the proximal end of the feedback line 50; preferably, one or more limiting devices may be provided.

[0082] Example 3

[0083] This embodiment provides a vascular suturing system, including a vascular suturing device and a suture adjuster. The various features already included in Embodiment 1 and Embodiment 2 are naturally inherited in this embodiment.

[0084] Preferably, the suture adjuster in this embodiment has the same structure as the suture adjuster in the Proglide vascular suture system, and its structure is prior art, so its specific structure will not be described in detail in this embodiment.

[0085] Preferably, the suture body 10 of the vascular suture device is further provided with a quick scissor opening 12 for cutting the suture 40 .

[0086] In this embodiment, the method of using the vascular suturing system is as follows:

[0087] Taking the suturing of the femoral artery as an example, first, a femoral artery angiography is performed inside the introducer sheath to confirm that the puncture point is on the common femoral artery to prevent the suture 40 from hitting the posterior wall of the blood vessel and possibly causing closure of the anterior and posterior walls of the blood vessel. The diameter, calcification, and tortuosity of the common femoral artery are evaluated, as well as whether the arterial wall has dissection or other vascular diseases. A guidewire is inserted through the introducer sheath. When withdrawing the sheath, pressure is applied to the groin to stop bleeding. The vascular suture device is then inserted along the guidewire until the guidewire rapid exchange port is close to the skin surface. The guidewire is removed before the guidewire rapid exchange port enters the body, and the device is continued to be pushed in until continuous pulsatile blood flow is seen at the marked cavity. The device is stopped from being pushed in, and the vascular suture device is kept at a 45° angle. The wrench 11 on the suture device body 10 is lifted to open the thread foot assembly 30. The device is gently withdrawn so that the thread foot assembly 30 rests against the arterial wall. If the thread foot assembly 30 is positioned correctly, blood return will stop or be significantly reduced.

[0088] Stabilize and hold the instrument, press the push handle assembly 20 until the push handle assembly 20 is in close contact with the proximal end of the suturing device body 10. After confirming that the push handle assembly 20 is in close contact with the instrument under direct vision, it proves that the front needle 22 is engaged with the front needle 22 connecting sleeve and the rear needle 23 is engaged with the rear needle 23 connecting sleeve. At this time, if the front needle feedback line 51 and the rear needle feedback line 52 can be pulled out, it proves that the connecting needle 21 and the connecting sleeve 31 are correctly engaged, and the next step can be performed. Otherwise, it is necessary to adjust the push handle assembly 20 or replace the vascular suturing device.

[0089] Pull out the push handle assembly 20 and the suture 40 completely from the stapler body 10 until the suture 40 is tightened, use the quick scissors 12 to cut the suture 40, relax the instrument, then push the wrench 11 back to its original position, retract the wire foot assembly 30, and withdraw the instrument until the guide wire quick marking port is exposed to the skin, tighten the two sutures 40 at the same time from the proximal part, and take the ends of the suture 40 out of the proximal tube 60.

[0090] Wrap one suture 40 around the index finger of the left hand and gently pull it in the coaxial direction of the muscle. Place the other suture 40 between the thumb and index finger of the left hand. Open the operating handle on the suture adjuster. Place the two sutures 40 in the suture 40 window at the distal end of the suture adjuster at the same time. Loosen the operating handle to insert the sutures 40 and push the knot forward. After the suture adjuster is sent to the position, gently pull the axis of the two sutures 40 to lock the knot. Remove the suture adjuster from the puncture channel and test the hemostatic effect by asking the patient to cough or bend his legs.

[0091] Once hemostasis is confirmed, use the scissors on the suture adjuster to cut the suture 40. While maintaining the tension of the suture 40, place both sutures 40 into the suture adjuster and push them to the surface of the artery. Pull the red scissor wrench 11 backward to cut the suture 40, and keep the wrench 11 closed to withdraw the suture 40 to complete the suturing of the blood vessel.

[0092] Those skilled in the art should understand that the operation method of the suture adjuster matches its own structure, and its structure and operation method are already public technologies, so the coordination relationship between its structures will not be described in detail.

[0093] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A vascular suturing device, characterized in that: include: - a molding assembly, the molding assembly comprising a molding body, with connecting sleeves provided on both sides of the molding body; The wall of the connecting sleeve is provided with a window and a baffle, the baffle extending radially inward from the proximal end of the window to the distal end, and a cutting portion is provided on the outer side of the distal end of the baffle, the cutting portion being opposite to the inner wall of the connecting sleeve; - a push handle assembly, wherein a connecting needle is provided at the distal end of the push handle assembly, and the connecting needle can be engaged with the connecting sleeve; - a feedback line, wherein a distal end of the feedback line is provided with a bulge, the bulge being disposed in the connecting sleeve, and a proximal end of the feedback line extending out of the window; The connecting needle can penetrate the connecting sleeve and radially press the blocking piece so that the cutting portion is embedded in the window to cut off the feedback line.

2. The vascular suture device according to claim 1, characterized in that: The cylindrical wall of the connecting sleeve is provided with a pair of the windows and the blocking pieces, and the windows and the blocking pieces are both symmetrically arranged along the circumferential direction.

3. The vascular suture device according to claim 2, characterized in that: The distal end of the connecting needle includes a boss portion and a positioning recess; the boss portion is used to squeeze the baffle when passing through the connecting sleeve and cause the cutting portion to cut off the feedback line; the positioning recess is used to provide an accommodating space for the resetting of the baffle and enable the baffle to block the boss portion.

4. The vascular suture device according to claim 3, characterized in that: The maximum outer diameter of the boss portion is smaller than the inner diameter of the connecting sleeve.

5. The vascular suture device according to claim 3, characterized in that: The minimum outer diameter of the positioning recess is smaller than the minimum distance between the pair of blocking pieces.

6. The vascular suture device according to claim 2, characterized in that: The axial length of the blocking piece is not greater than the axial length of the window.

7. The vascular suture device according to claim 6, characterized in that: The flap includes a resilient material having a shape memory function or a biasing arrangement.

8. The vascular suture device according to claim 7, characterized in that: The distal ends of a pair of the baffles are each provided with the cutting portion, and each cutting portion is correspondingly provided with a feedback line; Alternatively, the distal end of only one of the blocking pieces in the pair of blocking pieces is provided with the cutting portion, and the feedback line is only provided corresponding to the cutting portion.

9. The vascular suture device according to claim 7, characterized in that: The cutting portion is in a wedge shape extending toward the inner wall of the connecting sleeve, and the distance between the cutting portion and the inner wall of the connecting sleeve is greater than the diameter of the feedback line.

10. The vascular suture device according to claim 1, characterized in that: The diameter of the bulging portion is greater than the distance between the cutting portion and the inner wall of the connecting sleeve.

11. The vascular suture device according to any one of claims 1 to 10, characterized in that: The invention also includes a stapler body, a proximal tube and a distal tube arranged in sequence from the proximal end to the distal end; The proximal end of the push handle assembly is axially inserted into the stapler body; the distal end of the push handle assembly is inserted into the proximal tube, and the stitch foot assembly is arranged between the proximal tube and the distal tube.

12. The vascular suture device according to claim 11, characterized in that: The connecting needle includes a front needle and a rear needle; the connecting sleeve includes a front needle connecting sleeve and a rear needle connecting sleeve; the distal ends of the front needle connecting sleeve and the rear needle connecting sleeve are connected to each other through a connecting line; the feedback line includes a front needle feedback line and a rear needle feedback line.

13. The vascular suture device according to claim 12, characterized in that: The distal end of the front needle is provided with a suture knot and an axis, and the distal end of the rear needle is provided with a track.

14. The vascular suture device according to claim 12, characterized in that: There are two front needle feedback lines and / or two rear needle feedback lines.

15. The vascular suture device according to claim 11, characterized in that: The feedback line is passed through the proximal tube and passes through the proximal end of the stapler body.

16. The vascular suture device according to claim 15, wherein the suture device body is provided with a limiting device near the position where the proximal end of the feedback line passes through, and the limiting device is used to fix the proximal end of the feedback line.

17. A vascular suturing system, characterized in that: The vascular suture device according to any one of claims 1 to 16 further comprises a suture adjuster.

Images