CN109984778A - Medical sutures device and sewing system - Google Patents

Abstract

The present invention relates to a medical suturing device. The medical suturing device includes a puncture assembly, and the puncture assembly includes a first needle and a second needle. The needle tip of the first needle and the needle tip of the second needle are always directed toward The distal end of the piercing assembly extends. The invention also relates to a medical suturing system. The invention not only does not need to bend the puncture tube, but also only needs to push the puncture assembly once, without repeatedly pushing the puncture assembly for many times, to complete the two needle holes required for one suture, which is convenient to operate and saves operation time.

Description

Medical suturing device and suturing system

technical field

The invention relates to the technical field of interventional medicine, in particular to a medical suturing device and a suturing system.

Background technique

Patent foramen ovale is the most common congenital cardiac abnormality in adults, and 20%-25% of the foramen ovale are incompletely closed in the normal population. Unclosed foramen ovale can lead to thrombosis in the deep veins or pelvic veins of the lower extremities, air emboli caused by diving sickness or decompression sickness, and fat emboli formed after surgery or trauma into the left ventricular system and cause corresponding clinical symptoms . At the same time, patent foramen ovale is also closely associated with decompression sickness, migraine, and stroke.

In the past, the treatment of patent foramen ovale mainly relied on surgery, which has a high success rate and low fatality rate, but the trauma is large, and complications such as atrial fibrillation, pericardial effusion, postoperative bleeding and wound infection may occur. Therefore, in recent years, It has been rarely used. With the development of cardiac catheterization technology, patent foramen ovale can be radically cured by interventional therapy. Clinical practice in recent years has proved that this technique can permanently close the open foramen ovale, which is safe, effective and feasible.

Interventional treatments are mostly implanted with an occluder. The occluder generally includes two mesh discs and a connector connecting the two mesh discs. The two mesh discs are stuck in the left and right atria and block the housing. The outlet of the foramen ovale passage on both sides of the interval, and the connecting piece connects the left and right discs together through the passage of the foramen ovale to complete the sealing on both sides. Foramen ovale occluder is used for interventional treatment, although it can avoid thoracotomy and open-heart surgery, it can greatly reduce the surgical risk and wound area, and is conducive to postoperative recovery. However, due to the large size of the occluder, the protruding parts of the left and right atria are prone to cause thrombosis, and the foramen ovale is generally a sandwich structure, which will cause a large deformation when the occluder is used to clamp the atrial septum. This will cause the left and right discs to be misaligned, and there will be a drag force between the two discs, which will make the occluder's deformation and workload larger, so the overall structure will have a certain fatigue risk under the movement of the heart pulsation.

However, in the existing suturing method using a puncture needle, the puncture component has only one needle, and the puncture tube needs to be used to perform a puncture first, and then the puncture tube is adjusted to perform another puncture. That is to say, it is not only necessary to bend the A puncture tube is required, and the puncture assembly needs to be pushed twice for puncturing, which is very inconvenient and takes a long time.

SUMMARY OF THE INVENTION

Based on this, it is necessary to provide a medical suturing device and a suturing system in order to solve the problems of inconvenient operation and long operation time in the existing method of using a puncture needle for suturing.

A medical suturing device, the medical suturing device includes a puncture assembly, the puncture assembly includes a first needle and a second needle, and the needle tip of the first needle and the needle tip of the second needle are always directed toward the puncture assembly distal extension.

In one of the embodiments, the medical suturing device further includes a wire assembly, the wire assembly includes a suture, a first buckle and a second buckle, and one end of the suture is connected to the first buckle, The other end is connected with the second buckle, the first buckle is connected with the first needle, the second buckle is connected with the second needle, and the suture is clamped on the first needle between the needle and the second needle.

In one embodiment, the puncture assembly includes a double-ended puncture needle and a thimble, the double-ended puncture needle includes the first needle and the second needle, the first needle has a first cavity and two The second needle has an open end, the second needle has a second cavity and both ends are open, and the proximal end of the first needle is connected with the proximal end of the second needle and holds the proximal end of the first needle and the first needle. The proximal ends of the two needles are both open, a first opening is formed on the side of the first needle opposite to the second needle, and a second needle is formed on the second needle opposite to the first opening. an opening, the distal end of the first opening extends to the distal end of the first needle, the distal end of the second opening extends to the distal end of the second needle; the thimble Including a first ejector rod and a second ejector rod, the proximal end of the first ejector rod is connected with the proximal end of the second ejector rod, and the distal end of the first ejector rod is connected from the proximal end of the first ejector rod extending into the first cavity, and the distal end of the second ejector rod extends into the second cavity from the proximal end of the second needle; the first snap is accommodated in the first cavity , the second snap is accommodated in the second cavity, and the suture is located between the first opening and the second opening.

In one embodiment, the puncture assembly further includes a fixing member and an outer tube, the fixing member has a cavity and a proximal end is provided with an opening, the distal end of the outer tube is connected to the proximal end of the fixing member connected, and the inner diameter of the outer tube is larger than the diameter of the opening at the proximal end of the fixing piece, the proximal end of the double-ended puncture needle is connected with the distal end of the fixing piece, and the proximal end of the thimble is accommodated in the in the cavity of the fixture.

In one embodiment, the puncture assembly further includes a fixing block, the fixing block is accommodated in the cavity of the fixing piece, and the proximal end of the thimble is accommodated in the cavity of the fixing piece and is connected with the fixing piece The remote connection of the block.

In one of the embodiments, the medical suturing device further includes a first connector, and the proximal end of the first needle is connected with the proximal end of the second needle through the first connector.

In one of the embodiments, the medical suturing device further includes a second connector, and the proximal end of the first ejector rod and the proximal end of the second ejector bar are connected by the second connector.

In one embodiment, the first needle head and the second needle head are connected in a V-shape or a U-shape.

In one embodiment, the first needle is parallel to the second needle, and the first ejector pin is parallel to the second ejector pin.

In one of the embodiments, the first buckle is in the shape of a rod when it is tucked in the first cavity, and is in a flat expanded shape after sliding out from the distal end of the first needle. The two buckles are rod-shaped when they are contained in the second cavity, and are in a flat-expanded shape after being slid out from the distal end of the second needle.

In one embodiment, the puncture assembly includes a first ejector rod and a second ejector rod connected to the first ejector rod, the first ejector rod is the first needle, and the second ejector rod is the second needle; the first snap is tubular, and the first snap is sleeved on the first ejector rod, the second snap is tubular, and the second snap is sleeved on the second top rod.

In one of the embodiments, it comprises a first delivery wire cable and a first sheath, and further comprises the medical suturing device according to claim 1, wherein the distal end of the first delivery wire cable is connected to the puncture assembly, so The puncture assembly is accommodated in the first sheath.

In one embodiment, the medical suturing system further includes a drag assembly, a second delivery cable, and a second sheath, the drag assembly including an interconnected left disc and a third connector, the third connector The proximal end of the cable is connected to the distal end of the second delivery wire, the dragging assembly penetrates the second sheath from the proximal end of the second sheath, and the second sheath extends from the second sheath during delivery. The proximal end of the first sheath penetrates the first sheath.

In one of the embodiments, the left disk is in a straight line shape when it is retracted in the second sheath, and the left disk is a hollow disk-shaped body when it is not retracted in the second sheath, and the The distal end of the piercing assembly can penetrate the left disc.

In one embodiment, the third connecting member includes several guide wires, the distal end of the guide wire is connected to the left disc, and the proximal end of the guide wire is connected to the distal end of the second delivery wire. end connection.

In one of the embodiments, the guide wires are arranged at intervals or are braided to form the third connector.

In one of the embodiments, the first sheath has a third cavity and a fourth cavity parallel to each other, and the medical suturing device penetrates the first sheath from the proximal end of the first sheath, The second sheath penetrates the first sheath from the proximal end of the first sheath.

The above-mentioned medical suturing device not only does not need to bend the puncture tube, but also only needs to push the puncture component once, without repeatedly pushing the puncture component for many times, to complete the two needle holes required for one suture, which is convenient to operate and saves a certain amount of operation time. .

Description of drawings

Fig. 1 is the composition structure schematic diagram of the medical suturing system of embodiment 1;

2 is a schematic structural diagram of a suturing device in the medical suturing system of Example 1;

3 is a schematic cross-sectional structural diagram of the distal end of the suturing device in FIG. 2;

FIG. 4 is a schematic diagram of the overall cross-sectional structure of the suturing device in FIG. 2;

5 is a schematic structural diagram of the drag assembly housed in the second sheath in Embodiment 1;

6 is a schematic structural diagram of the drag assembly in Embodiment 1 after the left disk is released;

7 is a schematic diagram of the tissue structure at the foramen ovale in vivo;

8 is a schematic view of the left disc in the left atrium after being released in Example 1;

9 is a schematic diagram of the suturing device puncturing the overlapping area of the atrial wall when the left disc drags the atrial wall in Example 1;

Fig. 10 is the schematic diagram after withdrawing the dragging assembly in Fig. 9;

11 is a schematic diagram of the suturing device in Example 1 when the suturing device is clipped in the left atrium;

12 is a schematic structural diagram of a double-ended puncture needle in the medical suturing system of Example 1;

13 is a schematic structural diagram of a suturing device in the medical suturing system of Example 2;

FIG. 14 is a schematic cross-sectional structure diagram of FIG. 13;

Figure 15 is a schematic structural diagram of the double-ended puncture needle in Figure 13;

FIG. 16 is a schematic structural diagram of the wire assembly in the medical suturing system of Example 3. FIG.

Detailed ways

In order to make the objectives, technical solutions and advantages of the present invention clearer, 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, but not to limit the present invention.

It should be noted that, in the field of interventional medical devices, the end of the medical device implanted in the human body or animal body that is closer to the operator is generally called the proximal end, and the end that is farther away from the operator is called the distal end. This principle defines the proximal and distal ends of any component of a medical device.

The technical solutions of the present invention will be further described in detail below with reference to specific embodiments.

Example 1

Embodiment 1 proposes a medical suturing system 10, please refer to FIG. 1, which includes a medical suturing device 100, a first delivery cable 200, a first sheath 300, and a drag assembly 400, a second delivery cable 500, and a second delivery cable 500. Sheath 600. The proximal end of the medical suturing device 100 is connected to the distal end of the first delivery cable 200, the proximal end of the drag assembly 400 is connected to the distal end of the second delivery cable 500, and the first sheath tube 300 has a third cavity parallel to each other 310 and the fourth cavity 320, the medical suturing device 100 penetrates the first sheath 300 from the proximal end of the first sheath 300, and the drag assembly 400 penetrates the second sheath 600 from the proximal end of the second sheath 600, during delivery The second sheath 600 penetrates the first sheath 300 from the proximal end of the first sheath 300 .

Please refer to FIGS. 2-4 together. The medical suturing device 100 includes a wire assembly 110 and a puncturing assembly 120 . The thread assembly 110 includes a suture 111 , a first buckle 112 and a second buckle 113 . One end of the suture 111 is connected with the first buckle 112 , and the other end is connected with the second buckle 113 . In this embodiment, the first buckle 112 is tubular, the second buckle 113 is tubular, one end of the suture 111 is connected to the middle of the first buckle 112 , and the other end is connected to the middle of the second buckle 113 . Preferably, a hole is punched in the middle of the first buckle 112 and the second buckle 113, and one end of the suture 111 passes through the hole in the middle of the first buckle 112 and then knotted, so as to connect one end of the suture 111 to the first buckle 111. The clasp 112 is connected. Similarly, the other end of the suture 111 passes through the opening in the middle of the second clasp 113 and then knotted, so as to connect the other end of the suture 111 to the second clasp 113 . Both the first buckle 112 and the second buckle 113 can be made of nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, stainless steel 316L, polytetrafluoroethylene (PTFE) and other pipes after cutting, and polylactic acid or magnesium can also be used. , iron and its alloys and other absorbable materials, the respective lengths of the first buckle 112 and the second buckle 113 are 3mm-8mm, and the shapes can be in-line, Y-shaped or X-shaped. The separate parts can be cut from the pipe or directly machined. The diameter of the suture line 111 is 0.1mm-0.5mm, and its length can be determined according to the distance to be sutured, and generally 2mm-8mm can be selected. The suture 111 can be made of the same material as the first snap 112 or the second snap 113, or can be made of PA (nylon) thread, PET (polyethylene terephthalate) thread, PE (polyethylene) ) wire or ultra-high molecular weight polyethylene wire, etc.

The puncture assembly 120 includes a double-ended puncture needle 121 and a thimble 122 , as well as a fixing block 123 , a fixing member 124 and an outer tube 125 . The double-ended puncture needle 121 includes a first needle 1211 and a second needle 1212 . The needle tip of the first needle 1211 and the needle tip of the second needle 1212 always extend toward the distal end of the puncture assembly 120 , and the first needle 1211 has a first cavity 1213 And both ends are open, the second needle 1212 has a second cavity 1214 and both ends are open, the proximal end of the first needle 1211 is connected with the proximal end of the second needle 1212 and holds the proximal end of the first needle 1211 and the second needle 1212 The proximal ends of the first needles 1211 are provided with a first opening 1215 opposite to the second needle 1212, and the second needle 1212 is provided with a second opening opposite to the first opening 1215 (not shown in the figure). (shown), the distal end of the first opening 1215 extends to the distal end of the first needle 1211 , and the distal end of the second opening extends to the distal end of the second needle 1212 . The ejector pin 122 includes a first ejector rod 1221 and a second ejector pin 1222 , the proximal end of the first ejector pin 1221 is connected with the proximal end of the second ejector pin 1222 , and the outer diameter of the first ejector pin 1221 is slightly smaller than the inner diameter of the first needle head 1211 , and the outer diameter of the first ejector rod 1221 is larger than the outer diameter of the first buckle 112 , the outer diameter of the second ejector rod 1222 is slightly smaller than the inner diameter of the second needle 1212 , and the outer diameter of the second ejector rod 1222 is larger than that of the second pin 1222 The outer diameter of the buckle 113, the distal end of the first ejector rod 1221 extends from the proximal end of the first needle 1211 into the first cavity 1213, and the distal end of the second ejector rod 1222 extends from the proximal end of the second needle 1212 into the first cavity 1213. inside the second cavity 1214 .

When sewing, please refer to FIG. 3 again, the first buckle 112 is accommodated in the first cavity 1213 , the second buckle 113 is accommodated in the second cavity 1214 , and the outer diameter of the first ejector rod 1221 is larger than the second cavity 1214 . The outer diameter of a buckle 112, the outer diameter of the second push rod 1222 is greater than the outer diameter of the second buckle 113, the suture 111 is located between the first opening 1215 and the second opening, that is, the suture 111 is sandwiched between the first needle 1211 and the second needle 1212 . When the ejector pin 122 moves to the distal end, the first ejector rod 1221 pushes the first buckle 112 to move towards the distal end in the first cavity 1213 , and the second ejector rod 1222 pushes the second buckle 113 in the second cavity At the same time, one end of the suture 111 moves distally along the first opening 1215, and the other end moves distally along the second opening.

The double-ended puncture needle 121 can be made of nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, stainless steel 316L and other metal tubes by cutting and heat-setting, or can be made of polymer materials, such as polytetrafluoroethylene, by injection molding or processing. to make. Since the nickel-titanium alloy material has superelasticity and shape memory, the double-ended puncture needle 121 is preferably made of a nickel-titanium alloy tube, and the double-ended puncture needle 121 made of the nickel-titanium alloy tube is in In a compressed state, it can spring back to its original shape after being extended from the first sheath tube 300 . The maximum outer diameter of the double-ended puncture needle 121 is less than or equal to 1.8 mm, and the minimum inner diameter is greater than or equal to 0.6 mm. The distance between the distal end of the first needle 1211 and the distal end of the second needle 1212 is 1.1-1.3 times the length of the suture 111 . The width of the first opening 1215 is slightly larger than the diameter of the suture 111 , and the width of the second opening is also slightly larger than the diameter of the suture 111 . The thimble 122 can be made of the same material as the double-ended puncture needle 121 .

The fixing member 124 has a cavity 1241 and an opening 1242 at the proximal end, the distal end of the outer tube 125 and the proximal end of the fixing member 124 are connected by means of gluing, screwing, welding, etc., and the outer diameter of the outer tube 125 is equal to Or slightly smaller than the diameter of the proximal opening 1242 of the fixing member 124, the proximal end of the double-ended puncture needle 121 is connected to the distal end of the fixing member 124, the fixing block 123 is accommodated in the cavity 1241 of the fixing member 124, and the proximal end of the thimble 122 It is accommodated in the cavity 1241 of the fixing member 124 and connected to the distal end of the fixing block 123 . The distal end of the first delivery cable 200 extends from the proximal opening 1242 of the fixing member 124 into the cavity 1241 of the fixing member 124 and is connected with the proximal end of the fixing block 123. Dimensional tolerances for tight fit, etc. The outer tube 125 can be a metal tube or a polymer tube. The fixing member 124 can be made of implantable materials such as titanium alloy, cobalt-chromium alloy, stainless steel 316L, polytetrafluoroethylene and the like. The proximal end of the double-ended puncture needle 121 and the fixing member 124 may be fixedly connected by means of gluing or tight fitting tolerance. The distal end of the outer tube 125 and the proximal end of the fixing member 124 may be connected by means of threads, gluing, or tight-fitting locking. The inner diameter of the outer tube 125 is slightly larger than the outer diameter of the first transmission cable 200 . The outer tube 125 can be a braided steel cable, and can also be made of other metal materials, such as titanium alloy, cobalt-chromium alloy, stainless steel 316L and other soft guide wires or catheters. Both the first transmission wire cable 200 and the second transmission wire cable 500 can be braided wire cables, and can also be made of other metal materials, such as titanium alloy, cobalt-chromium alloy, stainless steel 316L and other soft guide wires or conduits.

The shape of the fixing member 124 is not limited as long as it can be accommodated in the cavity of the first sheath tube 300 . The shape of the fixing block 123 is also not limited, as long as it can be accommodated inside the fixing piece 124 and slide along the axial direction of the fixing piece 124 . The proximal end of the ejector pin 122 can be connected to the distal end of the fixing block 123 in various ways. In other embodiments, the proximal end of the first top rod 1221 may not be connected to the proximal end of the second top rod 1222, and the proximal end of the first top rod 1221 and the proximal end of the second top rod 1222 may be inserted into the fixing blocks 123 respectively. The distal end of the connector is connected, and the connection method can be screw connection, gluing, tight fit with dimensional tolerance, etc. In other embodiments, the puncture assembly 120 may not include the fixing block 123 , and the distal end of the first delivery wire 200 extends from the proximal opening 1242 of the fixing piece 124 into the cavity 1241 of the fixing piece 124 and communicates with the thimble 122 . The proximal end is connected, as long as the proximal end of the thimble 122 can be connected with the distal end of the first delivery wire 200 and move toward the distal end under the pushing of the first delivery wire 200 .

The proximal end of the first needle 1211 and the proximal end of the second needle 1212 are connected by a first connecting member 1217 , and the proximal end of the first ejector rod 1221 and the proximal end of the second ejector rod 1222 are connected through a fixing block 123 . In other embodiments, the proximal end of the first needle 1211 and the proximal end of the second needle 1212 may be directly connected. In other embodiments, the proximal end of the first ejector rod 1221 and the proximal end of the second ejector rod 1222 may be directly connected, or may be connected through a second connecting member.

The first needle 1211 and the second needle 1212 are connected in a V-shape, and the first ejector rod 1221 and the second ejector pin 1222 are connected in a V-shape. In other embodiments, the first needle 1211 and the second needle 1212 are parallel, and the proximal end of the first needle 1211 and the proximal end of the second needle 1212 are connected by a first connecting member 1217 , and the first needle 1211 and the second needle 1212 can be It is regarded as a U-shaped connection; the first top rod 1221 and the second top rod 1222 are parallel, and the proximal end of the first top rod 1221 and the proximal end of the second top rod 1222 are connected by a second connecting piece, and the first top rod 1221 The connection with the second top rod 1222 can be regarded as a U-shaped connection.

The dragging component 400 is used to drag the tissue at the site to be sutured, so that when the puncturing component 120 is piercing, the tissue at the site to be sutured will not deform excessively to affect the suturing effect. Please refer to FIG. 5 to FIG. 6 together. The towing assembly 400 includes a left disc 410 and a third connecting piece 420 that are connected to each other. The proximal end of the third connecting piece 420 is connected to the distal end of the second transmission cable 500. The towing assembly 400 The second sheath 600 is penetrated from the proximal end of the second sheath 600 . The left disc 410 has elasticity and shape memory, the left disc 410 is linear when it is retracted in the second sheath tube 600 (please refer to FIG. 5 ), and the left disc 410 is disc-shaped when it is not retracted in the second sheath tube 600 body (refer to FIG. 6 ), preferably, the left disc 410 is a hollow disc-shaped body when it is not retracted in the second sheath tube 600 , and the distal end of the double-ended puncture needle 121 can penetrate the left disc 410 . The overall shape of the left disk 410 can be circular, square, diamond, etc., the shape is not limited, and the hollow shape on the left disk 410 is also not limited, as long as the distal end of the double-ended puncture needle 121 can penetrate the left disk 410. The third connector 420 includes a plurality of guide wires 421 , the distal end of the guide wire 421 is connected to the left disc 410 , and the proximal end of the guide wire 421 is connected to the distal end of the second delivery wire 500 . A plurality of guide wires 421 are arranged at intervals to form the third connecting member 420 . In other embodiments, several guide wires 421 are braided to form the third connector 420 .

The left disk 410 can be heat-set by cutting a Nitinol tube. Both ends of the third connector 420 may be connected to the left disc 410 and the distal end of the second transmission cable 500 by welding, weaving and knotting, gluing, etc., respectively. The guide wire 421 is a flexible metal wire, such as nickel-titanium wire, stainless steel wire, PET wire, PA wire, PTFE wire, PE wire or ultra-high molecular weight polyethylene wire, etc., so it has good flexibility and can be bent arbitrarily. It has a certain strength and can withstand a sheath pulling force of more than 40N.

In this embodiment, the first sheath tube 300 with two cavities is used to separate the medical suturing device 100 and the dragging assembly 400 to avoid the inconvenience and risk caused by the mutual interference of the two in the first sheath tube 300 . In other embodiments, the first sheath tube 300 may also be a single-lumen tube. After the medical suturing device 100 is connected to the first delivery cable 200 , the medical suturing device 100 penetrates the first sheath tube from the proximal end of the first sheath tube 300 . 300 , after the drag assembly 400 is connected to the second delivery wire cable 500 and bundled in the cavity of the second sheath tube 600 , the second sheath tube 600 penetrates the first sheath tube 300 from the proximal end of the first sheath tube 300 .

In other embodiments, the medical suturing system 10 may not include the dragging assembly 400 and the second delivery cable 500 . After the medical suturing device 100 is connected with the first delivery cable 200 , the first sheath tube 300 is delivered to the in vivo target area. The target tissue can be sutured.

Taking the treatment of patent foramen ovale as an example, the medical suturing device 100 is not limited to the treatment of patent foramen ovale. Please refer to FIG. 7 , the box shows a schematic diagram of the in vivo tissue structure of the patent foramen ovale. The two pieces of atrial wall at the patent foramen ovale have an overlapping area, and the medical suturing device 100 can be used for suturing in the overlapping area. The two pieces of atrial wall are sutured together to block the blood shunt at the foramen ovale.

Please refer to Figure 8 to Figure 11 together. The stitching process includes the following steps:

1. Pass the distal end of the first delivery cable 200 through the opening at the proximal end of the fixing member 124 and connect it with the proximal end of the fixing block 123; pass the first buckle 112 from the distal end of the first needle 1211 into the first In the cavity 1213, the second buckle 113 penetrates into the second cavity 1214 from the distal end of the second needle 1212, and the suture 111 is located between the first opening 1215 and the second opening; The distal end of the assembly 120 penetrates into the third cavity 310 from the proximal end of the first sheath tube 300, and pushes it to the distal end of the first sheath tube 300;

2. Extend the second sheath tube 600 (not shown) with a tapered sheath core from the proximal end of the first sheath tube 300 into the fourth cavity 320 of the first sheath tube 300, and push it to the first sheath tube 300; the distal end of the sheath tube 300, and the distal end of the sheath core extends from the distal end of the second sheath tube 600;

3. With the aid of a bronchoscope and other equipment, after puncturing through the femoral vein, the distal end of the first sheath tube 300 is transported to the right atrium; the sheath core and the second sheath tube 600 are pushed out from the distal end of the first sheath tube 300 to make the sheath Insert the core and second sheath 600 into the foramen ovale to the left atrium; withdraw the sheath core;

4. Connect the distal end of the second delivery cable 500 with the proximal end of the third connecting piece 420; then, extend the proximal end of the second sheath tube 600 of the left disc 410 into the cavity of the second sheath tube 600, and connect the The left disc 410 is pushed to the distal end of the second sheath 600; the second sheath 600 is extended from the proximal end of the first sheath 300 into the fourth cavity 320, and the second sheath 600 is pushed to the first sheath the distal end of the tube 300;

5. Push the second sheath tube 600 towards the distal end, so that the proximal end of the compressed left disc 410 protrudes from the distal end of the first sheath tube 300; withdraw the second sheath tube 600 to make the compressed left disc 410 gradually Push out from the cavity of the second sheath tube 600 for release, and the released left disc 410 is in an unfolded shape; slowly pull the second delivery cable 500 towards the proximal end to make the left disc 410 close to the foramen ovale; fix the second transporting the steel cable 500, so that the second transporting steel cable 500 does not move relative to the sheath;

6. Push the first delivery cable 200 to the distal end, so that the distal end of the double-ended puncture needle 121 is aligned with the foramen ovale to be sutured for puncturing until the needle ends of the first needle 1211 and the second needle 1212 are completely pierced. Trans-atrial septum; fix the first delivery cable 200 so that it does not move relative to the first sheath 300;

7. Push the second sheath tube 600 distally to pass through the foramen ovale; withdraw the second delivery cable 500 so that the left disc 410 is contained in the cavity of the second sheath tube 600; then, withdraw the second sheath 600 to the outside of the body;

8. Push the first conveying wire cable 200 to the distal end, and the distal end of the first conveying wire cable 200 drives the fixing block 123 and the ejector pin 122 to move toward the distal end synchronously. The cavity 1213 pushes the first buckle 112 toward the end of the first needle 1211 , and the distal end of the second ejector rod 1222 pushes the second buckle 113 in the second cavity 1214 and moves toward the end of the second needle 1212 , at the same time, the suture 111 moves to the distal end between the first buckle 112 and the second buckle 113 along with the movement of the first buckle 112 and the second buckle 113; when the distal end of the first buckle 112 is After the first cavity 1213 is pushed out, and the distal end of the second buckle 113 is pushed out of the second cavity 1214, the outer tube 125 is pushed toward the proximal end and the double-ended puncture needle 121 is withdrawn. At this time, the first buckle 112 and the second The buckles 113 are all left in the left atrium and hang on the atrial wall, and most of the suture 111 is left in the right atrium, so that the two pieces of atrium walls at the foramen ovale are sutured together;

9. Retract the outer tube 125 so that the puncture assembly 120 is contained in the first sheath tube 300; withdraw the first sheath tube 300, the puncture assembly 120 and the first delivery cable 200 contained in the first sheath tube 300 out of the body to complete a suture.

It should be noted that another thread assembly 110 can be sewed in the overlapping area by the same operation, so as to enhance the suturing tightness between the two sheets of membranes. The number of repeated operations may be determined according to actual needs, and the number of required wire assemblies 110 may also be determined according to the number of repeated operations.

Referring to FIG. 12 , the length of the suture 111 is d, and the distance between the distal end of the first needle 1211 and the distal end of the second needle 1212 is D, since the suture 111 is located between the first needle 1211 and the second needle 1211 The two needles 1212 are in a straight line, so d is smaller than D, so after suturing, the suture 111 will be stretched between the two puncture points to ensure the suturing effect. It can be understood that by adjusting the angle between the first needle 1211 and the second needle 1212 and the initial installation position of the suture 111 between the first needle 1211 and the second needle 1212, the suture 111 can be adjusted between the two punctures tightness between points.

The medical suturing device 100 of the embodiment 1 adopts the interventional suturing method through the cooperation of the puncture assembly 120 and the thread assembly 110, which can simply and quickly complete the suturing operation in the body, avoiding, for example, thoracotomy in the treatment of patent foramen ovale, extremely The surgical risk and wound area are greatly reduced, which is beneficial to postoperative recovery. Secondly, the suture thread 111 does not need to be knotted in the body, which reduces the difficulty of the operation, saves the operation time, and relieves the pain of the patient. Thirdly, after suturing, only the wire assembly 110 is left in the body. Due to the small volume of the wire assembly 110, the risk of complications caused by the implant in the body can be greatly reduced, and the surrounding tissue will not be damaged. And since the suture thread 111 bears less tensile force, the risk of fatigue failure is also low.

Example 2

The same parts of Embodiment 2 and Embodiment 1 will not be repeated here. The main difference is that, please refer to FIG. 13 to FIG. 14 together, the first buckle 712 is tubular, the second buckle 713 is tubular, and the suture 711 One end is connected to the middle of the first buckle 712, the other end is connected to the middle of the second buckle 713, and the outer diameter of the first ejector rod 7221 is smaller than the inner diameter of the first buckle 712, and the outer diameter of the second ejector rod 7222 is smaller than the inner diameter of the second buckle 713, so that the distal end of the first push rod 7221 can extend into the cavity of the first buckle 712, and the distal end of the second push rod 7222 can extend into the cavity of the second buckle 713, The distal end of the first ejector rod 7221 is needle-shaped, and the distal end of the second ejector rod 7222 is needle-shaped. That is to say, the function of the distal end of the first ejector rod 7221 is the same as that of the first needle 1211 in the first embodiment, and the function of the distal end of the second ejector rod 7222 is the same as that of the second needle 1212 in the first embodiment. The puncturing function is the same, and it can also be understood that the first ejector rod 7221 is the solid first needle 7211 in this embodiment, and the second ejector rod 7222 is the solid second needle 7212 in this embodiment.

Further, the first needle 7211 is not provided with the first opening 1215, the second needle 7212 is not provided with the second opening, and the outer diameter of the first buckle 712 is greater than or equal to the inner diameter of the first needle 7211, and the first The outer diameter of the second buckle 713 is greater than or equal to the inner diameter of the second needle 7212 , the proximal end of the first buckle 712 is closer to the distal end of the medical suturing device than the distal end of the first needle 7211 , and the proximal end of the second buckle 713 is closer to the distal end of the medical suturing device than the distal end of the first needle 7211 . The distal end of the second needle 7212 is proximate the distal end of the medical suturing device.

It should be noted that, in this embodiment, the distal end of the first needle 7211 may or may not be in the shape of the needle in Embodiment 1, and the distal end of the second needle 7212 may also be retained in the shape of the needle in Embodiment 1. Needle-shaped, or not needle-shaped. It can also be understood that, in other embodiments, the first needle 7211 and the second needle 7212 may also be omitted.

When the medical suturing device of Example 2 is sutured, the suturing principle is: the distal end of the medical suturing device is transported to the foramen ovale in the right atrium through the first sheath tube 300; The distal end of the suturing device protrudes from the first sheath 300; the first delivery cable 200 is pushed distally so that the needle end of the first ejector rod 7221 and the needle tip end of the second ejector rod 7222 penetrate the interatrial septum until The first buckle 712 and the second buckle 713 completely enter the left atrium; keep the position of the fixation piece relative to the foramen ovale unchanged, and withdraw the first delivery wire 200 to move the fixation block 723 proximally to the position of the fixation piece. At the proximal end, at this time, the first buckle 712 and the second buckle 713 fall off naturally into the left atrium, thereby completing the suturing operation, and the suturing effect is the same as that of Embodiment 1.

Please refer to FIG. 15 , the length of the suture line 711 is d, and the distance between the distal end of the first ejector rod 7221 and the distal end of the second ejector rod 7222 is D, since the suture line 711 is located on the first ejector rod 7221 and the second top rod 7222 are in a straight line, so d is smaller than D, so after suture, the suture line 711 will be pulled between the two puncture points to ensure the suture effect. It can be understood that by adjusting the angle between the first top rod 7221 and the second top rod 7222 and the initial installation position of the suture line 711 between the first top rod 7221 and the second top rod 7222, the suture line 711 can be adjusted. The tightness between the two puncture points.

Example 3

The same parts of Embodiment 3 and Embodiment 1 will not be repeated here. The main difference is that the first buckle 812 is rod-shaped when it is contained in the first cavity, and is slid out from the distal end of the first needle. The second clasp 813 is in the shape of a rod when it is contained in the second cavity, and is in a flat shape after sliding out from the distal end of the second needle (please refer to FIG. 16 ). 16). The shapes of the first snap 812 and the second snap 813 after deployment are not limited, and are used to fix both ends of the suture at the end of the puncture point opposite to the main body of the suture, as long as it is not easy to get out of the puncture after suture. Just move one end of the point to the other. In other embodiments, the puncture assembly used in conjunction with the wire assembly in Embodiment 3 may also be the puncture assembly in Embodiment 2.

The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be regarded as the scope described in this specification.

The above-mentioned embodiments only represent several embodiments of the present invention, and the descriptions thereof are specific and detailed, but should not be construed as a limitation on the scope of the invention patent. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can also be made, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims (17)

1. a kind of medical sutures device, which is characterized in that the medical sutures device includes piercing assembly, the piercing assembly packet Include the first syringe needle and the second syringe needle, the needle point of the needle point of first syringe needle and second syringe needle is always towards the puncture group The distal end of part extends.

2. medical sutures device according to claim 1, which is characterized in that the medical sutures device further includes line group Part, the line component include suture, the first buckle and the second buckle, and one end of the suture and first buckle connect Connect, the other end is snapped connection with described second, it is described first buckle be connected with first syringe needle, it is described second buckle with it is described Second syringe needle is connected, and the suture clips are set between first syringe needle and second syringe needle.

3. medical sutures device according to claim 2, which is characterized in that the piercing assembly include double end puncture needle and Thimble, the double end puncture needle include first syringe needle and second syringe needle, first syringe needle have the first cavity and Both ends open, second syringe needle have the second cavity and both ends open, the proximal end of first syringe needle and second syringe needle Proximal end connection and keep the proximal end of first syringe needle and the proximal end of second syringe needle to be open, first syringe needle with The opposite side of second syringe needle is equipped with the first aperture, is relatively provided with second with first aperture on second syringe needle Aperture, the distal end of first aperture extend to the distal end of first syringe needle, and the distal end of second aperture extends to The distal end of second syringe needle；The thimble includes the first mandril and the second mandril, the proximal end of first mandril and institute The proximal end connection of the second mandril is stated, the distal end of first mandril extends proximally into first cavity from first syringe needle It is interior, distal end the extending proximally into second cavity from second syringe needle of second mandril；The first buckle receiving In in first cavity, second buckle is contained in second cavity, and the suture is located at described first and opens Between hole and second aperture.

4. medical sutures device according to claim 3, which is characterized in that the piercing assembly further includes fixing piece and outer Pipe, the fixing piece has a cavity and proximal end is equipped with an aperture, and the distal end of the outer tube is connect with the proximal end of the fixing piece, And the internal diameter of the outer tube is greater than the diameter of the fixing piece proximal bore, the proximal end of the double end puncture needle and the fixing piece Distal end connection, the proximal end of the thimble is contained in the cavity of the fixing piece.

5. medical sutures device according to claim 4, which is characterized in that the piercing assembly further includes fixed block, institute Fixed block is stated to be contained in the cavity of the fixing piece, the proximal end of the thimble be contained in the cavity of the fixing piece and with institute State the distal end connection of fixed block.

6. medical sutures device according to claim 3, which is characterized in that the medical sutures device further includes the first company Fitting, the proximal end of first syringe needle are connect with second syringe needle proximally by first connector.

7. medical sutures device according to claim 6, which is characterized in that the medical sutures device further includes the second company Fitting, the proximal end of first mandril are connect with second mandril proximally by second connector.

8. medical sutures device according to claim 1-7, which is characterized in that first syringe needle and described the Two syringe needles are connected in V-shape or U-shaped.

9. medical sutures device according to claim 7, which is characterized in that first syringe needle and second syringe needle are flat Row, first mandril are parallel with second mandril.

10. medical sutures device according to claim 3, which is characterized in that described first is buckled in and is packed described Be in planar development shape after being skidded off from the distal end of first syringe needle to be rod-shaped when in the first cavity, described second be buckled in by It is rod-shaped when being convergent in second cavity, is in planar development shape after being skidded off from the distal end of second syringe needle.

11. medical sutures device according to claim 2, which is characterized in that the piercing assembly include the first mandril and The second mandril being connected with first mandril, first mandril are first syringe needle, and second mandril is described the Two syringe needles；First buckle is tubulose, and first buckle is sheathed on first mandril, and second buckle is pipe Shape, and second buckle is sheathed on second mandril.

12. a kind of medical sutures system, which is characterized in that further include aforesaid right including the first conveying wirerope and the first sheath It is required that medical sutures device described in 1, the distal end of the first conveying wirerope is connected with the piercing assembly, the piercing assembly It is contained in first sheath.

13. medical sutures system according to claim 12, which is characterized in that the medical sutures system further includes towing Component, the second conveying wirerope and the second sheath, the towing component include left disk and third connector interconnected, and described the The proximal end of three connectors is connect with the distal end of the second conveying wirerope, and the towing component is passed through from the proximal end of second sheath Wear second sheath, and in conveying described in the second sheath from the proximal end of first sheath run through first sheath.

14. medical sutures system according to claim 13, which is characterized in that the left disk is convergent on second sheath It is linearly when interior, it is the discoid body with hollow out when the left disk is not convergent in second sheath, and the puncture group The distal end of part can penetrate the left disk.

15. medical sutures system according to claim 13, which is characterized in that the third connector, which includes several, leads Silk, the distal end of the seal wire are connect with the left disk, and the proximal end of the seal wire is connect with the distal end of the second conveying wirerope.

16. medical sutures system according to claim 15, which is characterized in that the seal wire is alternatively arranged or passes through braiding Constitute the third connector.

17. the described in any item medical sutures systems of 3-16 according to claim 1, which is characterized in that first sheath has The third cavity and the 4th cavity being parallel to each other, the medical sutures device run through described first from the proximal end of first sheath Sheath, second sheath run through first sheath from the proximal end of first sheath.