CN117257372A

CN117257372A - Suture unit and suture device

Info

Publication number: CN117257372A
Application number: CN202311376402.7A
Authority: CN
Inventors: 周祥; 黄程; 程智广
Original assignee: Shenzhen Chuangke Medical Technology Co ltd
Current assignee: Shenzhen Chuangke Medical Technology Co ltd
Priority date: 2023-10-20
Filing date: 2023-10-20
Publication date: 2023-12-22

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

Suture unit and suture device

Technical Field

The invention relates to the technical field of medical treatment, in particular to a suture unit and a suture device.

Background

Patent foramen ovale (Patent Foramen Ovale, PFO) is one of the common congenital heart diseases, with a incidence of about 25%. With the development of medical technology, more and more researches find that risks of cerebral apoplexy, migraine, peripheral arterial embolism, decompression sickness and the like of PFO patients are increased several times compared with normal people, so that the life quality of the patients is reduced, and even the life is endangered.

The current treatment methods are mainly oral antithrombotic drugs, PFO sealer implantation, surgical repair and the like. With the intensive development and further research of PFO interventions, PFO suturing techniques are receiving a great deal of attention. Meanwhile, tissue suturing techniques are widely used in other medical fields, such as vascular closure, fascial suturing, valve repair, endoluminal closure, and the like.

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

the PFO reticular plugging device mostly adopts a metal bracket structure, needs to perform anticoagulant drug intervention treatment for a long time after being implanted into a human body, has larger implant and large tissue contact friction area, and is easy to cause infection.

The absorbable and degradable PFO plugging device also needs anticoagulation treatment, and has a larger infection risk; the degradation speed of each area of the plugging device is uncontrollable, and the partial structure can be degraded and loosened to be free to enter the blood circulation, so that serious consequences are caused.

For larger wounds, most products need multiple needles or repeated operations for multiple times to finish, and the operation steps are more; each suture can leave knots or the sutures need mechanical structure butt joint, the operation difficulty is increased in the aspect of knotting the sutures, and the operation risk is increased. In addition, the device of partial products is larger, which is not beneficial to miniaturization of the products and limits the application scene.

Disclosure of Invention

The present invention is directed to a suture assembly unit and a suture device that solve one or more of the problems of the prior art.

In order to solve the above problems, the present invention provides a suture unit including 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.

Optionally, in the suturing unit, the collet is movably disposed relative to the main shaft in a direction parallel to an axis of the main shaft, and the size of the accommodating chamber varies as the collet moves relative to the main shaft.

Optionally, in the suturing unit, the cartridge includes a head portion connected to a distal end of the stem portion and remaining on a distal side of the main shaft, and a stem portion movably disposed in a direction parallel to an axis of the main shaft.

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

Optionally, in the suturing unit, the main shaft has a guiding groove extending in a direction parallel to the axis and opening outwards, the guiding groove is used for embedding a suture knot, and the needle rod is movably arranged in the guiding groove in a penetrating manner and can penetrate through the suture knot.

Optionally, in the suturing unit, the needle tube assembly further includes a first sleeve, the first sleeve is disposed in the guide groove along the extending direction of the guide groove, and can pass through the suture knot to limit the suture knot in the guide groove, and the needle rod is disposed through the first sleeve; 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.

Optionally, in the suturing unit, the distal end of the main shaft has an inclined butt joint, the chuck has an angle notch, and the butt joint and the opening of the angle notch are oppositely arranged to form the accommodating cavity.

Optionally, in the suturing unit, the chuck has a second guiding hole, the second guiding hole penetrates through the rod portion and the head portion in sequence along a direction parallel to the main shaft, a gap is formed at a proximal end of the main shaft, and the second guiding hole is communicated with the gap and is used for allowing a guide wire to pass through.

Optionally, in the suturing unit, the chuck includes a positioning hole and a limiting structure, the limiting structure is at least partially disposed in the positioning hole, the positioning hole is used for the needle to extend into, after the needle extends into the positioning hole, the limiting structure limits the position of the needle relative to the spindle, when the needle rod drives the needle to retract, the limiting structure releases the limit on the needle, so that the needle can be separated from the spindle.

Optionally, in the suturing unit, the needle side has a notch, the limiting structure includes an elastic member and a limiting member, an outer contour shape of the limiting member is matched with an inner contour shape of the notch, the elastic member is used for giving an elastic supporting force to the limiting member along a direction perpendicular to the positioning hole, and after the needle extends into the positioning hole, the limiting member is embedded into the notch so as to connect the needle to the chuck.

Optionally, in the suturing unit, the distal end of the needle shaft is screwed to the proximal end of the needle, and the needle shaft is disconnected from the needle by rotating about its own axis.

The present invention also provides a suturing device comprising a delivery tube and a suturing unit as defined in any one of the preceding claims; 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.

Optionally, in the suturing device, the suturing device further includes a second sleeve, the main shaft is connected with the conveying pipe through the second sleeve, and at least a portion of the second sleeve sleeved on the conveying pipe is of a hypotube structure.

Optionally, in the suturing device, the suturing device further includes a link movably disposed on the main shaft in a direction parallel to an axis of the main shaft, and a distal end of the link is connected to the collet to drive the collet to move by movement of the link.

In summary, the suturing unit and the suturing device provided by the present invention include: a distal suture unit; the distal suturing unit 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; the needle is detachably connected to the distal end of the needle bar, and the needle 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 wounds (defects), has a simple structure and is convenient to operate, and can be widely applied to suturing and plugging of PFO and ASD, valve repair, fascia closure, vascular closure, intracavity wound closure and the like.

Drawings

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

FIG. 1 is a schematic view of the whole structure of a bio-suture device according to an embodiment of the present invention;

FIG. 2 is a schematic longitudinal sectional view of a bio-suture device according to an embodiment of the present invention;

FIG. 3 is a schematic view of an exploded structure of a bio-suture device according to an embodiment of the present invention;

FIG. 4 is a schematic cross-sectional view of a spindle according to an embodiment of the present invention;

FIG. 5 is a schematic illustration of the assembly of a suture knot in an embodiment of the invention;

FIG. 6 is a schematic view of a needle cannula assembly according to an embodiment of the present invention;

FIG. 7 is a schematic cross-sectional view of a chuck according to an embodiment of the present invention;

FIG. 8 is a schematic diagram showing portions of a venous blood vessel and heart outside a patient Zhou Zhu;

figure 9 is a schematic representation of the operation of a bio-suture device according to an embodiment of the present invention entering a patient's heart and reaching a PFO tunnel;

figure 10 is a schematic view of the lower septal tissue of a PFO entering the containment chamber in an embodiment of the present invention;

FIG. 11 is a schematic view of a clamped lower septum tissue in accordance with an embodiment of the present invention;

figure 12 is a schematic view of upper septal tissue of a PFO entering a containment chamber in accordance with an embodiment of the present invention;

FIG. 13 is a schematic view of the suturing device withdrawn from the body in accordance with an embodiment of the present invention;

figure 14 is a schematic view of suturing upper and lower septal tissues of a PFO in accordance with an embodiment of the present invention;

FIGS. 15-17 are schematic views illustrating steps corresponding to performing multi-tissue-point suturing in accordance with an embodiment of the present invention;

FIG. 18 is a schematic view of suturing of a vascular valve and a heart valve in accordance with an embodiment of the present invention;

FIG. 19 is a schematic view of suturing a wound of a thoracoabdominal membrane and fascia after a minimally invasive surgery in accordance with an embodiment of the invention;

FIG. 20 is a schematic view of suturing a vascular wound according to an embodiment of the present invention;

wherein, each reference sign is explained as follows:

11-a stitching unit; 12-conveying pipe fittings; 13-a guidewire; 14-operating a handle;

111-a main shaft; 112-a chuck; 113-needle tubing assembly; 114-a second sleeve; 115-a receiving cavity; 116-limit grooves; 117-first guide holes; 118-notch;

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

1111-pair interface; 1112-guide slots; 1113-accommodation region;

1121-angle notch; 1122-a second guide hole; 1123-positioning holes; 1124-mounting slots; 1125-connecting holes; 1126-header; 1127—a stem; 1128-a boss;

11331-notch; 11332-platform; 11333-wire holes;

11234-an elastic member; 11233—a stop;

122-connecting rod;

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

Detailed Description

The invention will be described in detail with reference to the drawings and the embodiments, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments. It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated. As used herein, the terms "mounted," "connected," and "disposed" with respect to another element should be construed broadly and generally refer to the relationship of connection, coupling, engagement or transmission between two elements, and the connection, coupling, engagement or transmission between two elements may be direct or indirect through intervening elements, and should not be construed to indicate or imply that there is a spatial relationship between two elements, i.e., an element may be in any orientation, internal, external, above, below, or to one side of another element, unless specifically indicated otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In addition, in this document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to an end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to an end that first enters the patient.

Referring to fig. 1 in combination with fig. 2, the present embodiment provides a suture unit, which includes: a main shaft 111, a chuck 112 and a needle tube assembly 113, wherein a receiving cavity 115 is arranged between the chuck 112 and the distal end of the main shaft 111 for the object to be sutured to extend.

The needle tube assembly 113 is movably arranged on the main shaft 111 along the direction parallel to the axis of the main shaft 111, and can extend out of the distal end of the main shaft 111 to be in butt joint with the chuck 112; after the object to be sutured is inserted into the accommodating chamber 115, the head end of the needle tube assembly 113 can be passed through the object to be sutured to perform suturing by moving the needle tube assembly 113.

Further, referring to fig. 3 and 4, the needle tube assembly 113 includes a needle shaft 1132 and a needle 1133, the needle 1133 is detachably connected to the distal end of the needle shaft 1132, and the needle 1133 is used for fixing the suture; in operation, the needle 1133 is coupled to and decoupled from the collet 112 after the needle shaft 1132 is moved toward or away from the collet 112 to a desired distance.

In addition, the embodiment of the invention also provides a suturing device, which comprises a delivery tube 12 in addition to the suturing unit, the main shaft 111 is connected to the distal end of the delivery tube 12 along the axial direction of the main shaft, and the needle rod 1132 is movably arranged in the delivery tube 12 in a penetrating way, and the proximal end extends out of the proximal end of the delivery tube 12.

In the suturing unit and the suturing device provided by the embodiments of the present invention, the needle 1133 is detachably connected to the chuck 112 and the needle 1132, the needle 1132 is moved toward the chuck 112 to connect the needle 1133 to the chuck 112, and the needle 1133 is kept connected to the chuck 112 or the needle 1133 is disconnected from the chuck 112 and moves along with the needle 1132 as the needle 1132 moves away from the chuck 112. Therefore, when the suturing device of the present embodiment is used for suturing, the connection relationship between the needle 1133 and the chuck 112 and the needle 1132 may be changed according to the suturing requirement, so that the needle 1133 is connected to the needle 1132, or the needle 1133 is connected to the chuck 112, that is, after the needle 1133 is docked with the chuck 112 by conveying the needle 1132, the needle 1132 is withdrawn and separated from the needle 1133, and after separation, the needle 1132 may be driven to move towards the chuck 112, so that the needle 1132 is docked with the needle 1133, and the needle 2233 is pulled back, so as to complete the suturing scheme.

Correspondingly, the embodiment of the invention provides a sewing method, which comprises the following steps:

s11, conveying the main shaft 111 and the clamping head 112 to a target position;

s12, adjusting the positions of the main shaft 111 and the clamping head 112 so that a first object to be sutured stretches into the accommodating cavity 115 between the main shaft 111 and the clamping head 112;

s13, operating the needle tube assembly 113 to move towards the direction approaching the clamping head 112 so as to carry the suture to pass through the first object to be sutured, so that the needle 1133 is connected with the clamping head 112;

s14, releasing the connection between the needle bar 1132 and the needle 1133, and retracting the needle bar 1132;

s15, adjusting the positions of the main shaft 111 and the clamping head 112 so that a second object to be sutured stretches into the accommodating cavity 115;

s16, operating the needle bar 1132 to move towards the direction approaching the chuck 112 to pass through the second suture object and to be connected with the needle 1133 again;

s17, operating the needle bar 1132 and driving the needle 1133 to move away from the chuck 112, so as to carry the suture 1134 through the second suture object.

After the steps S11 to S17, the suture 1134 is pulled out and knotted, and the suture between the first suture object and the second suture object is completed. Wherein the first and second suturing objects may be two separate tissues that need to be sutured together, e.g., upper and lower septal tissues on a PFO tunnel, or tissues with defects, e.g., 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, prostheses, etc., and the inanimate objects may be used for simulation, calibration, training, etc.

Therefore, the suture unit and the suture device provided by the embodiment can continuously pass through the multi-point biological tissue around the wound (defect) by using only one complete suture 1134, have simple structure and convenient operation, and can be widely applied to suture and blockage of PFO and ASD, valve repair, fascia closure, vascular closure, intra-cavity wound closure and the like.

As shown in fig. 2, the receiving cavity 115 may be implemented by designing the distal end of the main shaft 111 to have an angled abutment 1111, and the chuck 112 to have an angle notch 1121 disposed corresponding thereto, and the abutment 1111 and the angle notch 1121 are disposed opposite to each other, forming the receiving cavity 115. The receiving cavity 115 allows more tissue to enter therein, ensuring that more tissue can be stapled, increasing the stapling strength, and avoiding tissue tearing.

In addition, referring to fig. 3 to 5, the main shaft 111 has a guiding groove 1112 extending in a direction parallel to the axis of the body and opening outwards, the guiding groove 1112 is used for embedding a suture knot 1135, and the needle bar 1132 is movably inserted into the guiding groove 1112 and can pass through the suture knot 1135. Specifically, a receiving area 1113 with an increased groove width and groove depth may be designed at a certain position (for example, a middle position) of the guide groove 1112 for setting the suture knot 1135, and specifically, the receiving area 1113 may be an inherent groove formed by removing material from the main shaft 111 to the inside, where the groove communicates with the guide groove 1112 and has a groove width greater than the groove width of the guide groove 1112. In this way, the suture 1134 may be configured in the following manner: the distal end is fixedly connected to the needle 1133, the middle portion is a pre-buried suture knot 1135, and the proximal end passes through the delivery tube 12 and out of the proximal end of the delivery tube 12. The needle 1133 may be provided with a connecting hole, and the distal end of the suture 1134 may be fastened by glue or clinching after passing through the connecting hole. The suture knot 1135 can be prefabricated by winding the suture 1134, that is, a pre-buried knot scheme of a monofilament suture 1134 is adopted, specifically, the distal end of the suture 1124 can be wound and bound on the sleeve 1131 by itself to form the knot 1135, the sleeve 1131 and the knot 1135 can slide and be pulled away, the suture knot 1135 stretches out two thread ends, one thread end directly penetrates out from the proximal end along the catheter 12, the other thread end is folded to the proximal end for a certain distance and then returns to the distal end to be connected with the needle 1133, the folded and overlapped distance is enough length reserved for suture tissue, after the suture is completed, the suture 1134 is completed at the distal end while the suture 1135 is penetrated under the traction of the needle 1133, the knot is firm, the size is small, and the blood circulation influence is small.

In this embodiment, the manner of fixing the suture 1134 to the needle 1133 is not limited, and any manner of fixing the suture 1134 to the needle 1133 without loosening may be used, for example, a wire hole 11333 may be provided in the needle 1133, and the distal end of the suture 1134 may be passed through the wire hole 11333 and fixed by knotting, etc. It is also preferred that the needle 1133 be shuttle-like with a minimum lateral dimension at the distal end, that is, the distal end of the needle 1133 be pointed. The distal ends of the needle shaft 1132 and the needle 1133 are designed to be pointed so as to pass through biological tissues. In addition, the wire attachment holes 11333 may be specifically designed on the shuttle to secure the distal ends of the sutures 1134.

With continued reference to fig. 3 and 5, the needle tube assembly 113 further includes a first sleeve 1131, where the first sleeve 1131 is disposed in the guide groove 1112 along the extending direction of the guide groove 1112 and is capable of passing through the suture knot 1135, so as to position the suture knot 1135 in the guide groove 1112, the needle rod 1132 is disposed through the first sleeve 1131, and the needle rod 1132 drives the needle 1133 to move proximally until the needle 1133 abuts against the first sleeve 1131, and when the needle 1133 pushes the first sleeve 1131 to move proximally until the needle 1133 moves proximally until the position of the suture knot 1135 is defined by the first sleeve 1131 after passing through the suture knot 1135. 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 the suture knot 1135 can be released from the guide groove 1112 after the first sleeve 1131 is withdrawn from the guide groove 1112.

In this embodiment, as shown in fig. 6, preferably, the distal end of the needle 1132 is connected to the proximal threaded hole 11333 of the needle 1133, and the needle 1132 is disconnected from the needle 1133 by rotating around its own axis, specifically, the distal end of the needle 1132 is pointed and has external threads, and the proximal end of the needle 1133 has a threaded hole 1136, and the internal threads of the threaded hole 1135 match the external threads of the needle 1132. The threaded connection between the needle 1132 and the needle 1133 allows the needle 1132 to be easily connected to and disconnected from the needle 1133 as needed. The distal end of the needle shaft 1132 and the proximal end of the needle 1133 may be detachably connected in other ways, for example, in other embodiments, the outer diameter of the distal end of the needle shaft 1132 may be variable, the needle shaft 1132 may be connected to the needle 1133 when the outer diameter of the distal end of the needle shaft 1132 increases, and the needle shaft 1132 may be disconnected from the needle 1133 when the outer diameter of the distal end of the needle shaft 1132 decreases. The manner in which the distal end of the needle shaft 1132 is detachably connected to the proximal end of the needle 1133 is not limiting to the present application and will not be described in detail herein.

Further, referring to fig. 7, the chuck 1133 has a positioning hole 1123, the positioning hole 1123 is used for the needle 1133 to extend into, the chuck 1133 further includes a limiting structure, the limiting structure is at least partially 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 rod 1132 drives the needle 1133 to retract, the limiting structure releases the limitation of the needle 1133, so that the needle 1133 can be separated from the main shaft 111.

In this embodiment, as shown in fig. 6, one side of the needle 1133 is a platform 11332 (or not), and the other side is provided with a notch 11331, and correspondingly, as shown in fig. 7, the chuck 112 is provided with a mounting groove 1124 perpendicular to the positioning hole 1123; the limiting structure comprises an elastic piece 11234 and a limiting piece 11233, one end of the elastic piece 11234 is fixed in the mounting groove 1124, and the other end of the elastic piece 11234 is fixedly connected with the limiting piece 11233, so that the elastic piece can give elastic supporting force to the limiting piece along the direction perpendicular to the positioning hole 1123, the limiting piece 11233 at least partially stretches out of the mounting groove 1124, and after the needle 1133 stretches into the positioning hole 1123, the limiting piece 11233 can be embedded into the notch 11331 to connect the needle 1133 to the chuck. In other embodiments, the limiting structure may be other structural designs, for example, a barb structure is disposed in the positioning hole 1123, and the barb structure hooks the needle 1133 from the notch of the needle 1133 after the needle 1133 extends into the positioning hole 1123. The specific structural design of the limiting structure does not constitute a limitation to the application.

Optionally, the collet 112 is fixed to the distal end of the main shaft 111, and the collet 112 is fixed to the distal end of the main shaft 111, so that the application range is limited although the structural design is simple. In view of this, in the present embodiment, it is preferable that the collet 112 is movably disposed with respect to the main shaft 111 in a direction parallel to the axis of the main shaft 111, and the size of the accommodation chamber 115 varies as the collet 112 moves with respect to the main shaft 111. Because the size of the accommodating cavity 115 is adjustable, the device can be suitable for stitching in more application scenes.

In order to enable the collet 112 to move relative to the main shaft 111 and to ensure that the receiving cavity 115 is always present between the collet and the distal end of the main shaft 111, in this embodiment, referring to fig. 7 in combination with fig. 2 and 3, the collet 112 may be designed to include a head portion 1126 and a stem portion 1127, wherein the head portion 1126 is connected to the distal end of the stem portion 1127 and remains located at the distal end side of the main shaft 11, and the stem portion 1127 is movably disposed in a direction parallel to the axis of the main shaft 111.

Preferably, referring to fig. 4, the main shaft 111 has a limiting groove 116 extending in a direction parallel to its axis, referring to fig. 7, the proximal end of the stem 1127 has a protrusion 1128, and the protrusion 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, a relative movement of the collet 112 and the spindle 111 in a direction parallel to the axis and a relative fixation in a direction perpendicular to the axis is achieved without adding further connecting structures and guiding structures.

Referring to fig. 2 and 3, in the present embodiment, the suturing device may further include a link 122, the link 122 is movably disposed on the main shaft 111 along a direction parallel to an axis of the main shaft 111, and a distal end of the link 122 is connected to the collet 112 to drive the collet 122 to move by moving the link 122. Specifically, the distal end of the connecting rod 122 extends into the limiting groove 116 along the moving direction thereof and is fixedly connected with the protruding portion 1128, the proximal end of the main shaft 111 has a first guiding hole 117, and the first guiding 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 link 122 and the boss 1128 may be achieved by designing the boss 1128 to have a connection hole 1125 for the insertion of the link 122.

In other embodiments, the movement of the collet 112 may be controlled by other means, for example, the link 122 may be replaced by a pull wire, and likewise, the distal end of the pull wire may extend into the limit groove 116 and be fixedly connected to the boss 1128, while the distal end of the boss 1128 may be connected to the limit groove 116 by an elastic member, which is used to enable the boss 1128 to move distally to return to the original position after the pull wire is forced by the end of the pull wire. The link 122 is preferably employed to control movement of the collet 112 in view of life and ease of structural design.

Further, referring to fig. 5, the collet 112 has a second guide hole 1122, and the second guide hole 1122 penetrates the stem 1127 and the head 1126 in sequence in a direction parallel to the main axis 111. Referring to fig. 4, a notch 118 may be disposed at the proximal end of the main shaft 111. The second guide hole 1122 is in communication with the notch 118 for passage of the guidewire 13 such that the guidewire 13 may be used to guide the suture device. The installation position of the notch 118 and the penetrating position of the needle bar 1132 are located at two opposite sides of the main shaft 111, and do not interfere with each other.

As shown in fig. 1 and 2, the suturing device according to the present invention may further include a delivery tube 12, the main shaft 111 is connected to a distal end of the delivery tube 12, and the needle tube assembly 113 and the connecting rod 122 are movably disposed through the delivery tube 12 and extend out of a proximal end of the delivery tube 12. The second guide hole 1122, the notch 118, and the lumen of the delivery tube 12 are sequentially connected to form a guidewire delivery channel.

In addition, as shown in fig. 2 and 3, the suturing device further includes a second sleeve 114, the main shaft 111 is connected with the conveying pipe 12 through the second sleeve 114, and at least a portion of the second sleeve 114 sleeved on the conveying pipe 12 is in a hypotube structure, which can increase flexibility of the connecting portion and improve passing performance of the whole system. In addition, when the second sleeve 114 is sleeved on the main shaft 111, the accommodating area 1113 is avoided.

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

The following describes in detail a specific procedure of suturing the suture device provided in this embodiment, taking an example of suturing the upper septum tissue and the lower septum tissue of the heart.

Fig. 8 shows a schematic view of a portion of a vein and heart outside a patient Zhou Zhu, with the aid of imaging equipment, the guidewire 13 is advanced from the femoral vein puncture 2131, along the inferior vena cava 213 into the right ventricle 221, through the Patent Foramen Ovale (PFO) tunnel 23 and into the left ventricle 222, thereby establishing a passageway.

The suturing device provided in this embodiment is then delivered along guide wire 13 to its distal end into the patient's heart and to PFO tunnel 23 as shown in fig. 9.

As shown in fig. 10, pushing link 122 at the device's proximal operating handle controls the distal movement of collet 112, while controlling the proximal operating handle to adjust the position of suturing unit 11 through delivery tube 12 to allow PFO's inferior septal tissue 232 to enter accommodation chamber 115.

As shown in FIG. 11, pulling the linkage 122 controls the cartridge 112 and the shaft 111 to move toward each other, clamping the lower septum tissue 232, and then pushing the needle shaft 1132 proximally moves the needle 1133 distally together, while the needle 1133 pulls the distal end of the suture 1134 together through the lower septum tissue 232 and to the anchor point of the cartridge 112 to be locked. The needle shaft 1132 is then rotated to loosen the threaded interface of the needle shaft 1132 and needle 1133 and withdraw the needle shaft 1132, leaving the suture 1134 through the lower septal tissue 232.

As shown in fig. 12, pushing link 122 controls collet 112 to loosen the fixation of lower septal tissue 232 while operating the operating handle such that the opening of receiving cavity 115 is directed toward upper septal tissue 231, then clamping upper septal tissue 231 on PFO tunnel 23 in the same manner, pushing needle 1132 through upper septal tissue 231 to the positioning anchor, and then rotating needle 1132 to allow the distal end of needle 1132 and the proximal end of needle 1133 to be threadably reconnected, retracting needle 1132 brings needle 1133 to draw suture 1134 through upper septal tissue 231.

As shown in fig. 13 and 14, after suturing, the guide wire 13 is removed, the needle bar 1132 is continuously withdrawn, the first sleeve 1131 is driven to move proximally together by the pushing of the needle 1133, the needle 1133 pulls the distal end of the suture 1134 to pass through the pre-buried suture knot 1135, at this time, the suture knot 1135 is released from the limit groove 116 on the main shaft 111 after being separated from the fixation of the first sleeve 1131, the suturing device is continuously withdrawn from the body as a whole, and both ends of the suture 1134 are pulled out of the body together; suture 1134 cutting device is delivered along the double ends of suture 1134 through femoral vein puncture 2131 to suture knot 1135, PFO tunnel 23 is fully closed under the pushing and pulling of suture 1134 cutting device and suture 1134 ends, while the excess ends are sheared off, and the suture 1134 cutting device is withdrawn to complete the suturing.

It should be noted that the above description is directed to suturing two tissue points, but it is understood that the biological tissue suturing provided by the present embodiment is also applicable to suturing multiple tissue points, and that disposable suturing of larger and longer wounds can be accomplished by multiple passes through the tissue points. Fig. 15-17 illustrate a process of suturing multiple tissue points of biological tissue 30, as shown in fig. 15-17, with needle 1133 pulling suture 1134 through point a on upper septal tissue 231, point b on lower septal tissue 232, point c on upper septal tissue 231, and point d on lower septal tissue 232 of the PFO incision, respectively, and through pre-buried suture knot 1135, and when passing through different tissue points, only the operating handle needs to be turned as needed to adjust the suturing position and move needle cannula assembly 113.

The suturing device provided in this embodiment may be used for Atrial Septal Defects (ASD) in addition to PFO, a particular example of which is provided. In addition, as shown in fig. 18, the suture can be used for suturing the vascular valve 25 and the heart valve, and can be used for suturing and repairing when the relevant valve is diseased and loses part or all of the functions. As shown in fig. 19, the device can be used for closing a wound 271 of a chest and abdomen diaphragm and fascia 27 after minimally invasive surgery. As shown in fig. 20, the suturing device can be used for closing a vascular wound, wherein the vascular wall 28 forms a wound 282 after minimally invasive puncture or trauma, and the suturing device of the present embodiment can be used for closing the wound 282 through epidermal tissue 281.

In summary, the suturing device provided in the embodiment of the present invention includes: a distal suturing unit comprising a main shaft, a collet and a needle cannula 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 the needle head 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 a plurality of points of biological tissues around a wound (defect); the device has simple structure and convenient operation, and can be widely applied to suture and blockage of PFO and ASD, valve repair, fascia closure, vascular closure, intra-cavity wound closure and the like.

It should also be appreciated that while the present invention has been disclosed in the context of a preferred embodiment, the above embodiments are not intended to limit the invention. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.

Claims

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

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.