CN117257372A - Suture unit and suture device - Google Patents

Abstract

The invention provides a suturing unit and a suturing device, comprising: the device comprises a main shaft, a chuck and a needle tube assembly; a containing cavity is formed between the chuck and the distal end of the main shaft; the needle tube component is movably arranged on the main shaft along the direction parallel to the axis of the main shaft and can extend out of the far end of the main shaft to be in butt joint with the chuck; the needle tube assembly comprises a needle rod and a needle head, wherein the needle head is detachably connected to the distal end of the needle rod and is used for fixing a suture; in operation, the needle is connected to or disconnected from the chuck after the needle shaft is moved toward or away from the chuck to a desired distance. When the suturing device provided by the invention is used for suturing biological tissues, the suturing device can continuously pass through multi-point biological tissues around a wound (defect), and has the advantages of simple structure, convenience in operation and wide application range.

Description

Suturing unit and suturing device

Technical field

The present invention relates to the field of medical technology, and in particular to a suturing unit and a suturing device.

Background technique

Patent Foramen Ovale (PFO) is one of the common congenital heart diseases, with an incidence rate of approximately 25%. With the development of medical technology, more and more studies have found that the risk of stroke, migraine, peripheral arterial embolism, decompression sickness, etc. in PFO patients is several times higher than that of the normal population, which not only reduces the patient's quality of life, but even endangers life.

Current treatment methods mainly include oral antithrombotic drugs, PFO occluder implantation, and surgical repair. With the in-depth development and further research of PFO interventional treatment, PFO suturing technology has received widespread attention. At the same time, tissue suturing technology is widely used in other medical fields, such as blood vessel closure, fascial suturing, valve repair, intraluminal closure, etc.

Currently, products commonly used to treat PFO or other tissue closure show the following shortcomings according to different usage scenarios:

PFO mesh occluders mostly use metal stent structures. After being implanted into the human body, long-term anticoagulant drug intervention is required. The implant is large, has a large contact and friction area with tissue, and can easily cause infection.

The absorbable and degradable PFO occluder also requires anticoagulation treatment and carries a greater risk of infection; the degradation rate of each area of the occluder is uncontrollable, and it is possible that part of the structure degrades and loosens and enters the blood circulation, causing serious consequences.

For larger wounds, most products require multiple stitches or repeated operations, with many steps; each suture will leave knots or the sutures require mechanical structural docking, which increases the difficulty of tying the sutures. , increasing the risk of surgery. In addition, some products have large devices, which is not conducive to product miniaturization and limits their application scenarios.

Contents of the invention

The object of the present invention is to provide a suturing unit and a suturing device to solve one or more problems in the prior art.

In order to solve the above problems, the present invention provides a suturing unit, which includes a main shaft, a chuck and a needle assembly;

A receiving cavity is formed between the collet and the distal end of the spindle;

The needle assembly is movably disposed on the main shaft in a direction parallel to the axis of the main shaft, and can extend out of the distal end of the main shaft to dock with the chuck;

The needle tube assembly includes a needle bar and a needle. The needle is detachably connected to the distal end of the needle bar. The needle is used to fix the suture; during operation, the needle bar moves toward or away from the chuck. After reaching the desired distance, the needle is connected or separated from the chuck.

Optionally, in the suturing unit, the collet is movably arranged relative to the main shaft in a direction parallel to the axis of the main shaft, and the size of the accommodation cavity increases with the size of the collet relative to the main shaft. Changes occur as the spindle moves.

Optionally, in the suturing unit, the chuck includes a head and a rod, and the head is connected to the distal end of the rod and remains on the distal side of the main shaft, so The rod portion is movably arranged in a direction parallel to the axis of the main shaft.

Optionally, in the suturing unit, the main shaft has a limiting groove extending in a direction parallel to its own axis, and the proximal end of the rod portion has a protruding portion, and the protruding portion extends into the suturing unit. In the limiting groove, and movably arranged in the limiting groove along the extending direction of the limiting groove.

Optionally, in the suturing unit, the main shaft has a guide groove extending in a direction parallel to the axis and open to the outside, and the guide groove is used for pre-embedding suture knots, and the needle bar It is movably inserted into the guide groove and capable of passing through the suture knot.

Optionally, in the suturing unit, the needle assembly further includes a first sleeve, the first sleeve is provided in the guide groove along the extension direction of the guide groove, and can pass through all the guide grooves. The suture knot is limited to the guide groove, and the needle bar is passed through the first sleeve; when the needle bar drives the needle to move proximally to the When the first cannula is against each other, push the first cannula to move toward the proximal end until the needle moves toward the proximal end and passes through the suture knot, then release the first cannula from the suture knot. The location of the suture knot is limited.

Optionally, in the suturing unit, the distal end of the main shaft has a docking port with an inclined angle, the chuck has an angular notch, and the docking port and the opening of the angular notch are arranged oppositely to form the entire suturing unit. The accommodation cavity.

Optionally, in the suturing unit, the clamp has a second guide hole that sequentially penetrates the stem and the head in a direction parallel to the main axis, and the The proximal end of the main shaft has a notch, and the second guide hole is connected with the notch for allowing the guide wire to pass through.

Optionally, in the suturing unit, the clamp includes a positioning hole and a limiting structure, the limiting structure is at least partially disposed in the positioning hole, and the positioning hole is used for the needle to extend. After the needle extends into the positioning hole, the limiting structure limits the position of the needle relative to the main shaft. When the needle bar drives the needle to retreat, the limiting structure releases the position of the needle. The needle is limited so that the needle can be detached from the main shaft.

Optionally, in the suturing unit, the side of the needle has a notch, the limiting structure includes an elastic member and a limiting member, and the outer contour shape of the limiting member is consistent with the inner shape of the notch. The contour shape matches, and the elastic member is used to give elastic support to the limiting member in a direction perpendicular to the positioning hole. After the needle extends into the positioning hole, the limiting member is embedded in the Notch to connect the needle to the collet.

Optionally, in the suturing unit, the distal end of the needle bar is threadedly connected to the proximal end of the needle, and the needle bar is disconnected from the needle by rotating around its own axis.

The present invention also provides a suturing device, which includes a delivery pipe and a suturing unit as described in any one of the preceding items; the main axis of the suturing unit is axially connected to the distal end of the delivery pipe, and the suturing unit The needle bar is movably inserted into the delivery pipe.

Optionally, in the suturing device, the suturing device further includes a second sleeve, the main shaft and the delivery pipe are connected through the second sleeve, and the second sleeve covers at least The part provided on the conveying pipe is a hypotube structure.

Optionally, in the suturing device, the suturing device further includes a connecting rod, the connecting rod is movably provided on the main shaft in a direction parallel to the axis of the main shaft, and the connecting rod is The distal end is connected to the collet to drive the movement of the collet through movement of the connecting rod.

To sum up, the suturing unit and suturing device provided by the present invention include: a distal suturing unit; the distal suturing unit includes a main shaft, a chuck and a needle assembly; a receiving chamber; the needle tube assembly is movably arranged on the main shaft in a direction parallel to the axis of the main shaft, and can extend out of the distal end of the main shaft and dock with the chuck; the needle tube assembly includes A needle bar and a needle head. The needle head is detachably connected to the distal end of the needle bar. The needle head is used to fix the suture. The needle head is detachably connected to the distal end of the needle bar. The needle head is used to fix the suture. When fixing the suture; during operation, after the needle bar moves toward or away from the chuck to a desired distance, the needle is connected or separated from the chuck. When using the suturing device provided by the present invention to suture biological tissue, it can continuously pass through multiple points of biological tissue around the wound (defect). It has a simple structure and is easy to operate. It can be widely used in suturing and sealing of PFO and ASD, as well as valve repair. , fascial closure, blood vessel closure, intraluminal wound closure, etc.

Description of the drawings

Those of ordinary skill in the art will understand that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. in:

Figure 1 is a schematic diagram of the overall structure of the biological suturing device provided by an embodiment of the present invention;

Figure 2 is a schematic structural diagram of a longitudinal section of the biological suturing device provided by an embodiment of the present invention;

Figure 3 is a schematic diagram of the exploded structure of the biological suturing device provided by an embodiment of the present invention;

Figure 4 is a schematic cross-sectional structural diagram of the main shaft in the embodiment of the present invention;

Figure 5 is a schematic diagram of the assembly of the suture knot in the embodiment of the present invention;

Figure 6 is a schematic structural diagram of the needle assembly in an embodiment of the present invention;

Figure 7 is a schematic cross-sectional structural diagram of the chuck in the embodiment of the present invention;

Figure 8 is a schematic diagram showing the peripheral main veins and heart of the patient;

Figure 9 is a working schematic diagram of the biological suturing device provided by the embodiment of the present invention entering the patient's heart and reaching the PFO tunnel;

Figure 10 is a schematic diagram of the lower diaphragm tissue of the PFO entering the accommodation cavity in the embodiment of the present invention;

Figure 11 is a schematic diagram of clamping the lower diaphragm tissue in the embodiment of the present invention;

Figure 12 is a schematic diagram of the upper diaphragm tissue of the PFO entering the accommodation cavity in the embodiment of the present invention;

Figure 13 is a schematic diagram of withdrawing the suturing device from the body in an embodiment of the present invention;

Figure 14 is a schematic diagram of suturing the upper septal tissue and lower septal tissue of PFO in an embodiment of the present invention;

Figures 15 to 17 are schematic diagrams corresponding to each step when performing multi-tissue point suturing in an embodiment of the present invention;

Figure 18 is a schematic diagram of the suturing of vascular valves and heart valves in an embodiment of the present invention;

Figure 19 is a schematic diagram of the wound suturing of the thoracoabdominal diaphragm and fascia after minimally invasive surgery in an embodiment of the present invention;

Figure 20 is a schematic diagram of suturing a blood vessel wound in an embodiment of the present invention;

Among them, the description of each reference symbol is as follows:

11-Suture unit; 12-Conveying pipe; 13-Guide wire; 14-Operation handle;

111-Spindle; 112-Collet; 113-Needle tube assembly; 114-Second sleeve; 115-Accommodating cavity; 116-Limiting groove; 117-First guide hole; 118-Notch;

1131-first sleeve; 1132-needle bar; 1133-needle; 1134-suture; 1135-suture knot; 1136-threaded hole;

1111- docking interface; 1112- guide groove; 1113- accommodation area;

1121-angle notch; 1122-second guide hole; 1123-positioning hole; 1124-installation slot; 1125-connection hole; 1126-head; 1127-rod; 1128-convex portion;

11331-notch; 11332-platform; 11333-wiring hole;

11234-elastic part; 11233-limiting part;

122-Connecting rod;

212-main venous blood vessel; 21-heart; 2131-femoral vein puncture port; 213-inferior vena cava; 221-right ventricle; 23-PFO tunnel; 222-left ventricle; 231-upper septal tissue; 232-lower septal tissue; 25-vascular valve; 27-thoracoabdominal diaphragm and fascia; 271-wound; 28-blood vessel wall; 281-epidermal tissue; 282-wound.

Detailed ways

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be described in detail below with reference to the drawings and specific embodiments. It should be noted that the drawings are in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the embodiments of the present invention. In addition, the structures shown in the drawings are often part of the actual structure. In particular, each drawing needs to display different emphasis, and sometimes uses different proportions. It should also be understood that, unless otherwise specified or pointed out, the terms "first", "second", "third" and other descriptions in the specification are only used to distinguish various components, elements, steps, etc. in the specification, rather than Used to express the logical relationship or sequential relationship between various components, elements, steps, etc. As used in the present invention, "mounted", "connected", and "connected", and one element is "set" on another element, should be understood in a broad sense, and usually only mean that there is a connection, coupling, cooperation or transmission relationship between the two elements. , and the two elements may be connected, coupled, matched or transmitted directly or indirectly through intermediate elements, and it cannot be understood as indicating or implying the spatial positional relationship between the two elements, that is, one element may be inside the other element , outside, above, below or to one side, unless the content clearly indicates otherwise. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

In addition, in this application document, "proximal end" and "distal end" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device, although "proximal end" and "distal end" "Distal" is not limiting, but "proximal" generally refers to the end of the medical device that is closest to the physician during normal operation, and "distal" generally refers to the end that first enters the patient's body.

Referring to Figure 1 and combined with Figure 2, this embodiment provides a suturing unit. The suturing unit includes: a main shaft 111, a collet 112 and a needle assembly 113. There is a gap between the collet 112 and the distal end of the main shaft 111. A receiving cavity, the receiving cavity 115 is used for the object to be sutured to extend into.

The needle assembly 113 is movably disposed on the main shaft 111 in a direction parallel to the axis of the main shaft 111, and can extend the distal end of the main shaft 111 to dock with the chuck 112; when the object to be sutured is extended, After entering the accommodation cavity 115, the needle assembly 113 is moved so that the head end of the needle assembly 113 can pass through the object to be sutured for suturing.

Further, please refer to Figures 3 and 4. The needle tube assembly 113 includes a needle bar 1132 and a needle 1133. The needle 1133 is detachably connected to the distal end of the needle bar 1132. The needle 1133 is used to fix the suture. During operation, after the needle bar 1132 moves toward or away from the chuck 112 to a desired distance, the needle 1133 is connected or separated from the chuck 112 .

In addition, an embodiment of the present invention also provides a suturing device. In addition to the suturing unit, the suturing device also includes a delivery pipe 12. The main shaft 111 is connected to the distal end of the delivery pipe 12 along its own axial direction. The needle bar 1132 is movably inserted into the delivery tube 12 and has its proximal end extending out of the proximal end of the delivery tube 12 .

In the suturing unit and the suturing device provided by the embodiment of the present invention, the needle 1133 is in a detachable connection relationship with the chuck 112 and the needle bar 1132. The needle bar 1132 passes toward the The collet 112 moves so that the needle 1133 is connected to the collet 112, and as the needle bar 1132 moves in a direction away from the collet 112, the needle 1133 remains connected to the collet 112, Or the needle 1133 releases the connection with the collet 112 and moves with the needle bar 1132 . Therefore, when suturing using the suturing device of this embodiment, the connection relationship between the needle 1133, the chuck 112, and the needle bar 1132 can be changed according to the suturing requirements, so that the needle 1133 and The needle bar 1132 is connected, or the needle 1133 is connected to the chuck 112, that is, after the needle 1133 is docked with the chuck 112 through the transportation of the needle bar 1132, the needle bar 1132 retreats and separates from the needle 1133. Finally, the needle bar 1132 can be driven to move toward the chuck 112 so that the needle bar 1132 is docked with the needle 1133 and the needle 2233 is pulled back, thereby completing the suturing plan.

Correspondingly, an embodiment of the present invention provides a suturing method, which includes the following steps:

S11, transport the spindle 111 and the chuck 112 to the target position;

S12, adjust the positions of the main shaft 111 and the collet 112 so that the first object to be sutured extends into the accommodation cavity 115 between the main shaft 111 and the collet 112;

S13, operate the needle assembly 113 to move in a direction close to the chuck 112 to carry the suture through the first object to be sutured, so that the needle 1133 is connected to the chuck 112;

S14, release the connection between the needle bar 1132 and the needle head 1133, and withdraw the needle bar 1132;

S15, adjust the positions of the main shaft 111 and the chuck 112 so that the second object to be sutured extends into the accommodation cavity 115;

S16, operate the needle bar 1132 to move in a direction close to the chuck 112 to pass through the second suture object and reconnect with the needle 1133;

S17, operate the needle bar 1132 and drive the needle 1133 to move in a direction away from the chuck 112 to carry the suture 1134 through the second suture object.

After the above-mentioned steps S11 to S17, the suture 1134 is drawn out and knotted, thereby completing the suture between the first suture object and the second suture object. Wherein, the first suture object and the second suture object may be two separate tissues that need to be sutured together, for example, they may be the upper diaphragm tissue and the lower diaphragm tissue on the PFO tunnel, or they may be tissues with defects. , for example, two different tissue points on an atrial septal defect (ASD). In addition, the first suture object and the second suture object may be inanimate objects such as animal models and prostheses, and the inanimate objects may be used for simulation, calibration, training and other operations.

It can be seen that by using the suturing unit and suturing device provided in this embodiment, only one complete suture 1134 can be used to continuously pass through multiple points of biological tissue around the wound (defect). The structure is simple, easy to operate, and can be widely used. It is used in suture closure of PFO and ASD, as well as valve repair, fascia closure, blood vessel closure, intraluminal wound closure, etc.

As shown in FIG. 2 , the accommodation cavity 115 can be realized by designing a docking port 1111 with a certain angle at the distal end of the main shaft 111 , and the chuck 112 having a corresponding angled notch 1121 . The interface 1111 and the angle notch 1121 are arranged opposite to form the accommodation cavity 115 . The accommodation cavity 115 can allow more tissue to enter, ensuring that more tissue can be sutured, increasing suturing strength, and preventing tissue tearing.

In addition, please refer to Figures 3 to 5. The main shaft 111 has a guide groove 1112 extending in a direction parallel to the body axis and open to the outside. The guide groove 1112 is used to pre-embed the suture knot 1135, so The needle bar 1132 is movably inserted into the guide groove 1112 and can pass through the suture knot 1135 . Specifically, an accommodating area 1113 with increased groove width and groove depth can be designed at a certain position (for example, the middle position) of the guide groove 1112 for setting the suture knot 1135. Specifically, the The accommodating area 1113 may be an inherent groove formed by removing material from the main shaft 111 . The groove is connected to the guide groove 1112 and has a groove width greater than that of the guide groove 1112 . In this way, the suture 1134 can be arranged in such a way that the distal end is fixedly connected to the needle 1133 , the middle part is a pre-embedded suture knot 1135 , and the proximal end passes through the delivery tube 12 from the delivery tube 12 The proximal end exits. The needle 1133 may be provided with a connection hole, and after the distal end of the suture 1134 passes through the connection hole, glue or riveting may be used to form a fastening connection. The suture knot 1135 can be prefabricated by winding the suture 1134, that is, using a pre-embedded knotting scheme of the monofilament suture 1134. Specifically, the distal end of the suture 1124 can be wrapped around itself and tied to the casing. A knot 1135 is formed on the suture 1131, and the sleeve 1131 and the knot 1135 can slide and be pulled away. The suture knot 1135 extends two threads, one of which passes directly from the proximal end along the catheter 12, and the other The thread head is folded and overlapped for a certain distance toward the proximal end and then returned to the distal end to connect with the needle 1133. The folded overlap distance is to reserve sufficient length for the sutured tissue. After the suturing is completed, it passes through the knot 1135 under the traction of the needle 1133 to complete the tissue closure. At the same time, the suture 1134 is knotted at the distal end. The knot is strong, small in size, and has little impact on blood circulation.

In this embodiment, the method of fixing the suture 1134 to the needle 1133 is not limited. Any method that can fix the suture 1134 to the needle 1133 without loosening is acceptable. For example, it can be The needle 1133 is provided with a wiring hole 11333, and the distal end of the suture 1134 is passed through the wiring hole 11333 and knotted to fix it, and so on. In addition, preferably, the needle 1133 is in the shape of a shuttle, and the distal end has a minimum lateral dimension, that is, the distal end of the needle 1133 is pointed. The distal ends of the needle shaft 1132 and the needle 1133 are designed to be pointed so as to facilitate penetrating biological tissue. In addition, the wiring hole 11333 can be specifically designed on the shuttle to fix the distal end of the suture 1134.

Please continue to refer to Figures 3 and 5. The needle tube assembly 113 also includes a first sleeve 1131. The first sleeve 1131 is provided in the guide groove 1112 along the extension direction of the guide groove 1112 and can pass through it. Through the suture knot 1135, the suture knot 1135 is limited in the guide groove 1112, the needle bar 1132 is passed through the first sleeve 1131, and the needle bar 1132 drives the When the needle 1133 moves toward the proximal end until the needle 1133 abuts the first cannula 1131, the needle 1133 pushes the first cannula 1131 to move toward the proximal end until the needle 1133 moves toward the proximal end. After moving through the suture knot 1135, the position of the suture knot 1135 is released from being restricted by the first sleeve 1131. The arrangement of the first sleeve 1131 ensures that the position of the suture knot 1135 is not affected during the movement of the needle bar 1132, and when the first sleeve 1131 withdraws from the guide groove 1112 Finally, the suture knot 1135 can be released from the guide groove 1112 .

In this embodiment, preferably, as shown in Figure 6, the distal end of the needle bar 1132 is connected to the proximal threaded hole 11333 of the needle head 1133, and the needle bar 1132 is released from the connection with the needle bar 1132 by rotating around its own axis. The connection between the needles 1133, specifically, the distal end of the needle shaft 1132 is pointed and has an external thread, the proximal end of the needle 1133 has a threaded hole 1136, and the threaded hole 1135 is internally threaded with the The external thread of the needle bar 1132 matches. Through the threaded connection between the needle bar 1132 and the needle head 1133, the needle bar 1132 and the needle head 1133 can be easily connected and separated as needed. The distal end of the needle bar 1132 and the proximal end of the needle head 1133 can also be detachably connected in other ways. For example, in other embodiments, the outer contour size of the distal end of the needle bar 1132 is variable. When the outline size of the distal outer wheel of the needle bar 1132 increases, the needle bar 1132 and the needle head 1133 are connected. When the outline size of the distal outer wheel of the needle bar 1132 decreases, the needle bar 1132 and the needle head 1133 are connected. The needles 1133 are disconnected. The manner in which the distal end of the needle shaft 1132 and the proximal end of the needle 1133 are detachably connected does not constitute a limitation on the present application, and will not be described in detail here.

Further, please refer to FIG. 7 . The chuck 1133 has a positioning hole 1123 for the needle 1133 to extend into. The chuck 1133 also includes a limiting structure. The limiting structure is at least Part of it is located in the positioning hole 1123. After the needle 1133 extends into the positioning hole 1123, the limiting structure limits the position of the needle 1133 relative to the main shaft 111. When the needle bar 1132 drives the When the needle 1133 retracts, the limiting structure releases the restriction on the needle 1133 so that the needle 1133 can be separated from the main shaft 111 .

As shown in Figure 6, in this embodiment, one side of the needle 1133 is a platform 11332 (it may not be a platform), and the other side has a notch 11331. Correspondingly, as shown in Figure 7, the chuck 112 has a mounting groove 1124 perpendicular to the positioning hole 1123; the limiting structure includes an elastic member 11234 and a limiting member 11233. One end of the elastic member 11234 is fixed in the mounting groove 1124. The other end of 11234 is fixedly connected to the limiting member 11233, so that the elastic member can give elastic support to the limiting member in a direction perpendicular to the positioning hole 1123, so that the limiting member 11233 at least partially extends. out of the mounting groove 1124, so that after the needle 1133 extends into the positioning hole 1123, the stopper 11233 can be inserted into the notch 11331 to connect the needle 1133 to the chuck. In some other embodiments, the limiting structure may also adopt other structural designs. For example, the positioning hole 1123 is provided with a barb structure. After the needle 1133 extends into the positioning hole 1123, the barb structure The puncture structure hooks the needle 1133 from the notch of the needle 1133 . The specific structural design of the limiting structure does not constitute a limitation on this application.

Optionally, the collet 112 and the distal end of the main shaft 111 remain fixed. When the collet 112 and the distal end of the main shaft 111 are fixedly connected, although the structural design is simple, the applicable scope is restricted. In view of this, in this embodiment, preferably, the chuck 112 is movably disposed relative to the spindle 111 in a direction parallel to the axis of the spindle 111 , and the size of the accommodation cavity 115 changes with the size of the clamp. The head 112 moves relative to the main shaft 111 to change. Since the size of the accommodation cavity 115 is adjustable, it can be suitable for suturing in more application scenarios.

In order to enable the chuck 112 to move relative to the main shaft 111 and ensure that the accommodation cavity 115 is always present between the chuck 112 and the distal end of the main shaft 111, in this embodiment, please refer to FIG. 7 in conjunction with FIG. 2 and FIG. 3. The chuck 112 can be designed to include a head 1126 and a rod 1127. The head 1126 is connected to the distal end of the rod 1127 and remains on the distal side of the spindle 11. The rod The portion 1127 is movably disposed in a direction parallel to the axis of the main shaft 111 .

Preferably, please refer to Figure 4. The main shaft 111 has a limiting groove 116 extending in a direction parallel to its own axis. Please refer to Figure 7. The proximal end of the rod portion 1127 has a protruding portion 1128. The protruding portion 1128 extends into the limiting groove 116 and is movably disposed in the limiting groove 116 along the extending direction of the limiting groove 116 . In this way, the chuck 112 and the spindle 111 can be relatively moved in a direction parallel to the axis and relatively fixed in a direction perpendicular to the axis without adding additional connecting structures and guide structures.

Please refer to Figures 2 and 3. In this embodiment, the suturing device may further include a connecting rod 122, which is movably disposed on the main shaft 111 in a direction parallel to the axis of the main shaft 111. And the distal end of the connecting rod 122 is connected to the collet 112 to drive the collet 122 to move through the movement of the connecting rod 122 . Specifically, the distal end of the connecting rod 122 extends into the limiting groove 116 along its own movement direction and is fixedly connected to the protruding portion 1128. The proximal end of the main shaft 111 has a first guide hole 117, so The first guide hole 117 allows the connecting rod 122 to extend into the limiting groove 116 . In addition, as shown in FIG. 5 , the connection between the connecting rod 122 and the protruding part 1128 can be achieved by designing the protruding part 1128 to have a connecting hole 1125 for the connecting rod 122 to be inserted.

In some other embodiments, other methods can be used to control the movement of the clamp 112. For example, the connecting rod 122 can also be replaced by a pull wire. Similarly, the distal end of the pull wire extends into the limiting groove 116. The inner part is fixedly connected to the protruding part 1128. At the same time, an elastic member can be used to connect the distal end of the protruding part 1128 to the limiting groove 116. The elastic member is used to make the protruding part 1128 can move distally and return to the initial position after the pulling wire ends exerting force on it. However, considering the service life and the convenience of structural design, it is preferable to use the connecting rod 122 to control the movement of the chuck 112 .

In addition, please refer to FIG. 5 , the chuck 112 has a second guide hole 1122 that sequentially penetrates the rod portion 1127 and the head 1126 in a direction parallel to the main axis 111 . Referring to Figure 4, a notch 118 may be provided at the proximal end of the main shaft 111. The second guide hole 1122 is connected with the notch 118 for allowing the guide wire 13 to pass through, so that the guide wire 13 can be used to guide the position of the suturing device. The setting position of the notch 118 and the insertion position of the needle bar 1132 are located on opposite sides of the main shaft 111 and do not interfere with each other.

As shown in Figures 1 and 2, the suturing device provided by the embodiment of the present invention may further include a delivery pipe 12, the main shaft 111 is connected to the distal end of the delivery pipe 12, the needle assembly 113 and the connection The rods 122 are movably inserted through the delivery tube 12 and extend out of the proximal end of the delivery tube 12 . The second guide hole 1122, the notch 118 and the inner cavity of the delivery tube 12 are connected in sequence to form a guidewire delivery channel.

In addition, preferably, as shown in Figures 2 and 3, the suturing device further includes a second sleeve 114, and the main shaft 111 and the delivery pipe 12 are connected through the second sleeve 114. At least the part of the second sleeve 114 that is sleeved on the transport pipe 12 has a hypotube structure. The hypotube structure can increase the flexibility of the connecting part and improve the throughput performance of the entire system. In addition, when the second sleeve 114 is sleeved on the main shaft 111 , it avoids the accommodation area 1113 .

In order to facilitate operation, the suturing device provided in this embodiment also includes an operating handle provided at the proximal end of the delivery tube 12, and the delivery tube 12, the connecting rod 133 and the needle assembly 113 are controlled through the operating handle. move.

Taking the suturing of the upper diaphragm tissue and the lower diaphragm tissue of the heart as an example, the specific process of suturing the suturing device provided in this embodiment will be described in detail below.

Figure 8 shows a schematic diagram of the patient's peripheral main veins and heart. With the assistance of imaging equipment, the guidewire 13 is entered from the femoral vein puncture port 2131, enters the right ventricle 221 along the inferior vena cava 213, and then passes through the foramen ovale. The closed (PFO) tunnel 23 enters the left ventricle 222, thereby establishing a tunnel.

Then, as shown in FIG. 9 , the suturing device provided in this embodiment is transported along the guide wire 13 to its distal end, enters the patient's heart, and reaches the PFO tunnel 23 .

As shown in Figure 10, the connecting rod 122 is pushed at the proximal operating handle of the device to control the chuck 112 to move distally, and at the same time, the proximal operating handle is controlled to adjust the position of the suturing unit 11 through the delivery pipe 12, so that the lower septal tissue 232 of the PFO Enter the accommodation cavity 115.

As shown in Figure 11, pull the connecting rod 122 to control the relative movement of the chuck 112 and the main shaft 111, clamp and fix the lower septal tissue 232, and then push the needle bar 1132 from the proximal end to drive the needle 1133 to move distally together, and at the same time, the needle 1133 pulls the suture. The distal ends of the wires 1134 pass together through the inferior septal tissue 232 and are locked after reaching the positioning anchor point of the collet 112 . Then rotate the needle bar 1132 to loosen the threaded interface of the needle bar 1132 and the needle head 1133, and withdraw the needle bar 1132, leaving the suture 1134 to pass through the inferior septal tissue 232.

As shown in Figure 12, push the connecting rod 122 to control the clamp 112 to loosen the fixation of the lower septal tissue 232, and at the same time operate the operating handle so that the opening of the accommodation cavity 115 faces the upper septal tissue 231, and then use the same The method is to clamp the upper septal tissue 231 on the PFO tunnel 23, push the needle bar 1132 through the upper septal tissue 231 to the positioning anchor point, and then rotate the needle bar 1132 to reconnect the distal end of the needle bar 1132 and the proximal end of the needle 1133 through threads, and return The needle withdrawal lever 1132 drives the needle 1133 to pull the suture 1134 through the superior septal tissue 231 .

As shown in Figures 13 and 14, after the suturing is completed, the guide wire 13 is withdrawn, and the needle rod 1132 is continued to be withdrawn. Under the push of the needle 1133, the first cannula 1131 is moved proximally together, and at the same time, the needle 1133 pulls the suture 1134. The distal end passes through the pre-embedded suture knot 1135. At this time, the suture knot 1135 is released from the fixation of the first sleeve 1131 and released from the limiting groove 116 on the main shaft 111, and the entire suture device is continued to be withdrawn from the body. , and pull both ends of the suture 1134 out of the body together; transport the suture 1134 shearing device along the double thread ends of the suture 1134 through the femoral vein puncture port 2131 to reach the suture knot 1135, and connect the suture 1134 shearing device and The PFO tunnel 23 is completely closed under the pushing and pulling of the suture 1134 thread ends, and the excess thread ends are cut off at the same time, and the suture 1134 shearing device is withdrawn to complete the suturing.

It should be noted that the above description is directed to the suturing of two tissue points, but it can be understood that the biological tissue suturing provided by this embodiment is also applicable to the suturing of multiple tissue points. By passing through the tissue points multiple times, it is possible to Complete one-time suturing of larger and longer wounds. Figures 15 to 17 illustrate a process of suturing multiple tissue points of the biological tissue 30. As shown in Figures 15 to 17, the needle 1133 pulls the suture 1134 through point a on the upper septal tissue 231 of the PFO wound. , point b on the lower septal tissue 232, point c on the upper septal tissue 231 and point d on the lower septal tissue 232, and pass through the pre-embedded suture knot 1135. When passing through different tissue points, just Just rotate the operating handle to adjust the suturing position and move the needle tube assembly 113 as needed.

In addition to being used in PFO, the suturing device provided in this embodiment can also be used in atrial septal defect (ASD), of which PFO is a special case. In addition, as shown in Figure 18, it can also be used for suturing the blood vessel valve 25 and the heart valve, and can be sutured and repaired when the relevant valve becomes diseased and loses part or all of its function. As shown in Figure 19, it can be used to close the wound 271 of the thoracoabdominal diaphragm and fascia 27 after minimally invasive surgery. As shown in Figure 20, it can be used to close blood vessel wounds. In the figure, the blood vessel wall 28 forms a wound 282 after minimally invasive puncture or trauma. The suturing device of this embodiment can be used to pass through the epidermal tissue 281 to complete the closure of the wound 282.

To sum up, the suturing device provided by the embodiment of the present invention includes: a distal suturing unit, the distal suturing unit includes a main shaft, a collet and a needle assembly; a gap is formed between the collet and the distal end of the main shaft. accommodating cavity; the needle tube assembly is movably disposed on the main shaft in a direction parallel to the axis of the main shaft, and can extend out of the distal end of the main shaft and dock with the chuck; the needle tube assembly includes a needle a rod and a needle, the needle is detachably connected to the distal end of the needle rod, the needle is detachably connected to the distal end of the needle rod, the needle is used to fix the suture; during operation, the After the needle bar moves toward or away from the chuck to a desired distance, the needle is connected or separated from the chuck. When using the suturing device provided by the present invention to suture biological tissue, it can continuously pass through multiple points of biological tissue around the wound (defect); it has a simple structure and is easy to operate, and can be widely used in suturing and sealing of PFO and ASD, as well as valve repair. , fascial closure, blood vessel closure, intraluminal wound closure, etc.

In addition, it should be recognized that although the present invention has been disclosed above in preferred embodiments, the above embodiments are not intended to limit the present invention. For any person familiar with the art, without departing from the scope of the technical solution of the present invention, they can use the technical content disclosed above to make many possible changes and modifications to the technical solution of the present invention, or modify it into equivalent changes, etc. Effective examples. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

Claims (14)

1. A suturing unit comprising a main shaft, a chuck and a needle tube assembly;

a containing cavity is formed between the chuck and the distal end of the main shaft;

the needle tube component is movably arranged on the main shaft along the direction parallel to the axis of the main shaft and can extend out of the far end of the main shaft to be in butt joint with the chuck;

the needle tube assembly comprises a needle rod and a needle head, wherein the needle head is detachably connected to the distal end of the needle rod and is used for fixing a suture; in operation, the needle is connected to or disconnected from the chuck after the needle shaft is moved toward or away from the chuck to a desired distance.

2. The suturing unit of claim 1, wherein the cartridge is movably disposed relative to the shaft in a direction parallel to an axis of the shaft, the size of the receiving chamber varying as the cartridge moves relative to the shaft.

3. The suturing unit of claim 2, wherein the cartridge comprises a head portion and a stem portion, the head portion being connected to a distal end of the stem portion and remaining on a distal side of the shaft, the stem portion being movably disposed in a direction parallel to an axis of the shaft.

4. A suturing unit according to claim 3, wherein the main shaft has a limit groove extending in a direction parallel to the axis thereof, and the proximal end of the shaft has a boss projecting into the limit groove and being movably disposed in the limit groove in the extending direction of the limit groove.

5. The suturing unit of claim 1, wherein the main shaft has a guide slot extending in a direction parallel to the axis and open outwardly, the guide slot being for embedding a suture knot, the needle bar being movably disposed in the guide slot and being capable of passing through the suture knot.

6. The suturing unit of claim 5, wherein the needle cannula assembly further comprises a first cannula disposed within the guide slot along an extension of the guide slot and capable of passing through the suture knot to retain the suture knot within the guide slot, the needle shaft passing through the first cannula; when the needle rod drives the needle head to move towards the proximal end to abut against the first sleeve, the first sleeve is pushed to move towards the proximal end until the needle head moves towards the proximal end to pass through the suture knot, and the limit of the first sleeve on the position of the suture knot is released.

7. The suturing unit of claim 1, wherein the distal end of the shaft has an angled pair of ports, the cartridge having an angled notch, the pair of ports and the opening of the angled notch being disposed opposite one another to form the receiving chamber.

8. The suturing unit of claim 1, wherein the cartridge has a second guide bore extending sequentially through the shaft and the head in a direction parallel to the main shaft, the proximal end of the main shaft having a notch, the second guide bore communicating with the notch for passage of a guidewire.

9. The suturing unit of claim 1, wherein the cartridge includes a locating aperture and a limiting structure, the limiting structure being at least partially disposed within the locating aperture, the locating aperture being configured to allow the needle to extend into the locating aperture, the limiting structure defining a position of the needle relative to the shaft after the needle extends into the locating aperture, the limiting structure releasing the needle from the shaft when the needle is retracted by the needle shaft.

10. The suturing unit of claim 9, wherein the needle has a recess in a side thereof, the retaining structure including a resilient member and a retaining member, the retaining member having an outer contour shape matching an inner contour shape of the recess, the resilient member being adapted to impart resilient support force to the retaining member in a direction perpendicular to the locating hole, the retaining member being adapted to engage the recess after the needle is inserted into the locating hole to attach the needle to the cartridge.

11. The suturing unit of claim 1, wherein the distal end of the needle shaft is threadably coupled to the proximal end of the needle, and wherein the needle shaft is decoupled from the needle by rotating about its own axis.

12. A suturing device comprising a delivery tube and a suturing unit according to any one of claims 1-11; the main shaft of the suturing unit is connected to the distal end of the conveying pipe in the axial direction, and the needle rod of the suturing unit movably penetrates through the conveying pipe.

13. The suturing device of claim 12, further comprising a second sleeve coupled between the shaft and the delivery tube via the second sleeve, wherein at least a portion of the second sleeve that is disposed over the delivery tube is of hypotube construction.

14. The suturing device of claim 12, further comprising a linkage movably disposed to the shaft in a direction parallel to the axis of the shaft, and wherein a distal end of the linkage is coupled to the cartridge for driving movement of the cartridge by movement of the linkage.