EP4719211A1

EP4719211A1 - Tissue suturing device and operating method thereof and operating assembly

Info

Publication number: EP4719211A1
Application number: EP24730201.1A
Authority: EP
Inventors: Sijin He; Jie Zhang
Original assignee: Cilag GmbH International
Current assignee: Cilag GmbH International
Priority date: 2023-05-24
Filing date: 2024-05-24
Publication date: 2026-04-08
Also published as: WO2024240920A1; CN119014929A

Abstract

The present invention relates to the technical field of surgical instruments. Disclosed are a tissue suturing device and an operating method thereof and an operating assembly. In the operating assembly, an operating member is movable along a wing driving path, a transition path, and a needle driving path which are sequentially implemented. In the wing driving path, the operating member drives, by means of a positioning member, a wing driving member to move from a third position to a fourth position, and the operating member is disengaged from a needle driving member. In the transition path, the operating member is rotated by a preset angle to drive the positioning member to rotate to a position where the positioning member and a tube body are locked, so that the wing driving member is maintained in the fourth position, and the operating member is engaged with the needle driving member and is movable along the needle driving path. In the needle driving path, the operating member drives the needle driving member to move from a first position to a second position. The operating assembly can sequentially operate stabilizing wings and a suturing needle, and avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device.

Description

TISSUE SUTURING DEVICE AND OPERATING METHOD THEREOF AND OPERATING ASSEMBLY

TECHNICAL FIELD

The present invention relates to the technical field of surgical instruments, and specifically relates to an operating assembly for a tissue suturing device, a tissue suturing device, and an operating method of a tissue suturing device.

BACKGROUND OF THE INVENTION

During an operation, surgeons usually need to use tissue closure instruments to suture a patient's wound to be sutured, such as an incision of the abdominal cavity.

Existing tissue closure instruments typically include a cannula, stabilizing wings, and a puncture needle. The stabilizing wings are disposed at a distal end of the cannula, and the puncture needle is arranged within the cannula and can extend out of the cannula. When in use, an operator inserts the cannula into the wound to be sutured, and then operates the tissue closure instrument to unfold the stabilizing wings on the inside surface of the tissue of the wound to be sutured, thereby stabilizing the cannula. Then, the puncture needle is operated to extend out of the cannula and pass through the tissue to reach the stabilizing wings, thereby completing the arrangement of the suture.

During actual suturing, a skilled surgeon can achieve correct puncture of the puncture needle by virtue of experience. For many surgeons, however, due to various factors such as inexperience or accidental contact, the suturing needle will usually be extended out of the cannula before the stabilizing wings are unfolded, which may cause unnecessary injury to patients or the surgeons themselves.

BRIEF SUMMARY

In view of the above problems existing in the prior art, a first aspect of the present invention provides an operating assembly for a tissue suturing device. The operating assembly can sequentially operate the stabilizing wings and the suturing needle, and avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device. In order to achieve the objective described above, the present invention provides an operating assembly for a tissue suturing device. The operating assembly comprises a tube body, a needle driving member, a wing driving member, a positioning member, and an operating member, wherein the tube body comprises a proximal end, a distal end, and an axial channel extending between the proximal end and the distal end; the needle driving member is axially movably disposed within the axial channel; the wing driving member is axially movably disposed within the axial channel; the positioning member is connected to the wing driving member, and is movable in the circumferential direction relative to the wing driving member; and at least a part of the operating member is movably disposed within the axial channel and detachably engaged with the positioning member; wherein the operating member is movable along a wing driving path, a transition path, and a needle driving path which are sequentially implemented; in the wing driving path, the operating member is not engaged with the needle driving member so that the needle driving member is maintained in a first position, the first position being used to cause a suturing needle in a tissue suturing state to be in a retracted state, and the operating member drives the wing driving member from a third position to a fourth position by means of the positioning member, the third position being used to cause stabilizing wings to be in a folded state, and the fourth position being used to cause the stabilizing wings to be in an unfolded state; and in the transition path, the operating member is rotated by a preset angle to drive the positioning member to rotate to a position where the positioning member and the tube body are locked, so that the wing driving member is maintained in the fourth position, and the operating member is engaged with the needle driving member and is movable along the needle driving path; and in the needle driving path, the operating member drives the needle driving member to move from the first position to a second position, the second position being used to cause the suturing needle to be in an extended state.

In this technical solution, both the driving of the needle driving member and the driving of the wing driving member are implemented by means of the operating member, and the operating member comprises the wing driving path, the transition path and the needle driving path which are sequentially implemented. Hence, when in actual use, in the wing driving path, the operating member can only drive the wing driving member by means of the positioning member but cannot drive the needle driving member. At the time, even if the operating member is incorrectly operated or accidentally touched, the operating member cannot drive the needle driving member to move axially towards the distal end, and the suturing needle installed on the needle driving member thus cannot extend out of the tube body. In this way, accidental extension of the suturing needle can be completely avoided, thereby significantly improving the safety of using the tissue suturing device. By means of the transition path, the operating member is rotated by the preset angle, so that the positioning member and the tube body are locked, the wing driving member is maintained in the fourth position, and the operating member is engaged with the needle driving member and is movable along the needle driving path. In this way, in the needle driving path, the operating member can drive the needle driving member to move from the first position to the second position, so that the suturing needle extends out of the tube body. When the stabilizing wings and the suturing needle need to be retracted, the steps are simply performed reversely in sequence.

In some embodiments, in the transition path, the preset angle comprises a first preset angle and a second preset angle, wherein the operating member drives the positioning member to rotate by the first preset angle to lock the positioning member and the tube body, so that the wing driving member is maintained in the fourth position; and when the operating member continues to rotate by the second preset angle to reach the needle driving path, the operating member is disengaged from the positioning member and engaged with the needle driving member.

In some embodiments, the first preset angle is less than or equal to the second preset angle.

In some embodiments, the operating member is provided with a wing driving pin thereon, the positioning member is provided with a driving hole, the driving hole has an opening the size of which is smaller than the diameter of the wing driving pin, and the wing driving pin can squeeze through the opening to fit into the driving hole so that the operating member is engaged with the positioning member, so as to enable the operating member to drive the positioning member to rotate by the first preset angle; and when the operating member is rotated by the second preset angle, the wing driving pin squeezes through the opening and exits from the driving hole, so that the operating member is disengaged from the positioning member.

In some embodiments, the operating member is provided with a wing driving pin thereon, the positioning member is provided with a driving hole, the driving hole has an opening facing the distal end, and the size of the opening is smaller than the diameter of the wing driving pin, wherein the wing driving pin can squeeze through the opening to fit into the driving hole so that the operating member is engaged with the positioning member, and wherein in the wing driving path and the transition path, the wing driving pin fits into the driving hole, and in the needle driving path, the wing driving pin squeezes through the opening to exit from the driving hole, so that the operating member is disengaged from the positioning member.

In some embodiments, the wing driving member comprises an axially extending driving shaft, the positioning member is provided with an axially extending mating slot, the driving shaft is mated with the mating slot, and the mating slot has a circumferential length greater than the diameter of the driving shaft, so that the operating member can drive the positioning member along the transition path to rotate, relative to the driving shaft, to the position where the positioning member and the tube body are locked.

In some embodiments, the mating slot is provided with a mating port in the circumferential direction, and the driving shaft fits into the mating slot by means of the mating port.

In some embodiments, the operating assembly comprises at least two positioning members circumferentially spaced apart from each other, the at least two positioning members can simultaneously be engaged with or disengaged from the operating member, and the at least two positioning members cooperate with the wing driving member, and can simultaneously move in the circumferential direction relative to the wing driving member.

In some embodiments, a guide slide channel for the wing driving member to pass through is formed on the needle driving member.

In some embodiments, a position retaining structure is provided on the needle driving member, and when the needle driving member is moved to the second position, the position retaining structure cooperates with the tube body to be in a stop state to block the needle driving member from continuing to move axially, so that the needle driving member is maintained in the second position.

In some embodiments, when the needle driving member is moved to the second position, the wing driving member in the fourth position blocks the needle driving member from continuing to move axially while the needle driving member maintained in the second position blocks the wing driving member from returning.

In some embodiments, the wing driving member comprises a driving rod, and two connecting rods circumferentially spaced apart from each other, wherein distal ends of the two connecting rods are connected by means of a connecting portion, and the driving rod is connected to the connecting portion and extends toward a distal end of the operating assembly, and wherein each of the connecting rods is connected to a positioning member corresponding thereto.

In some embodiments, axially extending guide slide channels are formed on at least two opposing side portions of the needle driving member, and the two connecting rods axially pass through the guide slide channels corresponding thereto, respectively.

In some embodiments, when the needle driving member is moved to the second position, the connecting portion of the wing driving member in the fourth position contacts a bottom portion of the needle driving member to block the needle driving member from continuing to move axially.

In some embodiments, the wing driving path, the transition path, and the needle driving path are formed between the tube body and the operating member, wherein the wing driving path extends toward the proximal end and along the axial direction, the needle driving path extends toward the distal end and along the axial direction, and the transition path is arranged in the circumferential direction of the tube body, so that the operating member can move axially along the wing driving path, then rotate along the transition path by the preset angle and then reach the needle driving path, and then move axially along the needle driving path.

In some embodiments, a wing driving guide slot providing the wing driving path, a transition guide slot providing the transition path, and a needle driving guide slot providing the needle driving path are formed on an axial sidewall of the tube body, wherein a guide column is provided on the operating member, and the guide column is movable along the wing driving guide slot, the transition guide slot, and the needle driving guide slot.

In some embodiments, the tube body comprises at least two half tubes which can be joined together, wherein a set of the wing driving path, the transition path, and the needle driving path is formed on the at least two half tubes.

In some embodiments, two sets of the wing driving guide slot, the transition guide slot, and the needle driving guide slot are formed on the at least two half tubes; wherein at least two guide columns are provided on the operating member, and each of the guide columns is movable along a set of the wing driving guide slot, the transition guide slot, and the needle driving guide slot corresponding thereto. In some embodiments, the tube body comprises at least two half tubes which can be joined together, wherein a set of the wing driving path, the transition path, and the needle driving path is formed on one of the half tubes.

In some embodiments, a set of the wing driving guide slot, the transition guide slot, and the needle driving guide slot is formed on each of the half tubes, at least two guide columns are provided on the operating member, and each of the guide columns is movable along the wing driving guide slot, the transition guide slot, and the needle driving guide slot of a half tube corresponding thereto.

In some embodiments, an axial slot and a circumferential slot in communication with each other are formed on one of an inside surface of an axial sidewall of the tube body and the positioning member, and a protruding block is formed on the other of the inside surface and the positioning member, wherein when the operating member moves axially along the wing driving path from an initial position to the transition path, the protruding block and the axial slot are axially and slidably mated relative to each other; and when the operating member drives the positioning member to rotate along the transition path until the protruding block is mated with the circumferential slot, the positioning member is locked to the tube body to be in a locked position.

In some embodiments, a needle driving pin extending radially outwards is formed on the operating member, an axially extending guide channel is formed on an end surface of the needle driving member facing the operating member, and an expansion slot extending radially outwards is formed on an inner surface of the guide channel at a predetermined position, wherein when the operating member moves axially along the wing driving path to the transition path, the needle driving pin moves axially along the guide channel to the expansion slot, so that the operating member remains disengaged from the needle driving member; and when the operating member is rotated to the needle driving path along the transition path, the needle driving pin enters and fits into the expansion slot, so that the operating member is engaged with the needle driving member.

In some embodiments, two needle driving pins are provided and are circumferentially spaced apart, and two expansion slots are provided and are circumferentially spaced apart, wherein the two needle driving pins can simultaneously enter and fit into the respective expansion slots corresponding thereto, and can simultaneously exit from the respective expansion slots corresponding thereto. In some embodiments, a reference mark is provided on one of the operating member and the tube body, and a wing driving mark and a needle driving mark circumferentially spaced apart at a preset angle are provided on the other of the operating member and the tube body, the wing driving mark being different from the needle driving mark, wherein when the wing driving mark and the reference mark are axially aligned, the operating member can axially move from an initial position along the wing driving path; and when the operating member is rotated to the needle driving path along the transition path, the needle driving mark and the reference mark are axially aligned.

In some embodiments, an unlocking rotation indicator arrow and a locking rotation indicator arrow are provided on an end surface of the operating member at a proximal end.

In a second aspect, the present invention provides a tissue suturing device, comprising the operating assembly according to any of the foregoing described in the first aspect, stabilizing wings, and a suturing needle, wherein the stabilizing wings are hinged to the distal end of the tube body and hinged to the wing driving member; and the suturing needle is disposed on the needle driving member and located in the tube body; wherein the stabilizing wings can be unfolded and folded, and the suturing needle can extend from within the tube body to a puncture position and can retract back into the tube body. In this way, as described in the first aspect above, by means of the operating assembly, the tissue suturing device can completely avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device.

In a third aspect, the present invention provides an operating method of a tissue suturing device. The operating method comprises: configuring an operating member of a tissue suturing device to have a wing driving path, a transition path, and a needle driving path which are sequentially implemented, wherein in the wing driving path, the operating member moves from an initial position along the wing driving path to the transition path, so that the operating member drives a wing driving member to move from a third position to a fourth position by means of driving a positioning member of the tissue suturing device, so as to unfold stabilizing wings of the tissue suturing device; in the transition path, the operating member is driven to rotate by a preset angle along the transition path, so that the positioning member is locked to a tube body of the tissue suturing device to maintain the wing driving member in the fourth position, and the operating member is engaged with a needle driving member of the tissue suturing device and is movable along the needle driving path; and in the needle driving path, the operating member is driven to drive the needle driving member to move from a first position to a second position, so as to drive a suturing needle to extend out of the tube body of the tissue suturing device to a puncture position.

In the operating method, in the wing driving path, the operating member can only drive the wing driving member by means of the positioning member but cannot drive the needle driving member. At the time, even if the operating member is incorrectly operated or accidentally touched, the operating member cannot drive the needle driving member to move axially, and the suturing needle installed on the needle driving member thus cannot extend out of the tube body. In this way, accidental extension of the suturing needle can be completely avoided, thereby significantly improving the safety of using the tissue suturing device. By means of the transition path, the operating member is rotated by the preset angle, so that the positioning member and the tube body are locked to maintain the wing driving member in the fourth position, and the operating member is engaged with the needle driving member of the tissue suturing device and is movable along the needle driving path. In this way, in the needle driving path, the operating member can drive the needle driving member to move from the first position to the second position, so that the suturing needle extends out of the tube body.

In some embodiments, in the transition path, the operating member is driven to drive the positioning member to rotate by a first preset angle along the transition path, so that the positioning member is locked to the tube body to maintain the wing driving member in the fourth position; and the operating member is driven to continue to rotate by a second preset angle along the transition path to reach the needle driving path, so that the operating member is disengaged from the positioning member and engaged with the needle driving member.

In some embodiments, the operating member is driven to move axially along the wing driving path, and the operating member is driven to move axially along the needle driving path.

In some embodiments, the operating member is driven reversely along the needle driving path to drive the needle driving member to move from the second position to the first position, so as to drive the suturing needle to retract back into the tube body; the operating member is driven reversely along the transition path to rotate by a preset angle, so that the positioning member is unlocked from the tube body of the tissue suturing device, and the operating member is disengaged from the needle driving member; and the operating member is driven reversely along the wing driving path to drive the wing driving member to move from the fourth position to the third position, so as to fold the stabilizing wings.

In a fourth aspect, the present invention provides a tissue suturing device capable of implementing the operating method of a tissue suturing device according to any of the foregoing described in the third aspect. In this way, as described above, the tissue suturing device can completely avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device.

It will be apparent that elements or features described in each of the above embodiments may be used individually or in combination in other embodiments.

BRIEF DESCRIPTION OF DRAWINGS

In the drawings, the dimensions and proportions do not represent those of actual products. The drawings are illustrative only and certain non-essential elements or features are omitted for the sake of clarity.

FIG. 1 is a perspective view schematically showing a tissue suturing device according to an embodiment of the present invention from one angle of view.

FIG. 2 is a schematic structural diagram in which a half tube of a tube body of the tissue suturing device of FIG. 1 is removed to clearly show an operating assembly.

FIG. 3 is a partially enlarged schematic structural diagram of FIG. 2, in which the operating member is in a wing driving path.

FIG. 4 is a perspective view of the positioning member in FIG. 3 from one angle of view.

FIG. 5 is a perspective view of the positioning member in FIG. 4 from another angle of view.

FIG. 6 is a partial schematic structural diagram of a half tube of the tissue suturing device of FIG. 1.

FIG. 7 is a perspective view of a wing driving member of the tissue suturing device of FIG.

1.

FIG. 8 is a perspective view of the operating member of the tissue suturing device of FIG.

1. FIG. 9 is a perspective view of a needle driving member of the tissue suturing device of FIG. 1 from one angle of view.

FIG. 10 is a perspective view of the needle driving member of FIG. 9 from another angle of view.

FIG. 11 is a perspective view of the tissue suturing device of FIG. 1 after implementing the wing driving path to unfold stabilizing wings.

FIG. 12 is a partially enlarged schematic structural diagram of the tissue suturing device of FIG. 11, in which a half tube is omitted.

FIG. 13 is a schematic view of the partially enlarged structure of FIG. 12 from another angle of view.

FIG. 14 is a schematic view in which the operating member in FIG. 12 drives the positioning member to rotate by a first preset angle A.

FIG. 15 is a schematic view in which the operating member in FIG. 14 drives the positioning member to rotate by a second preset angle B.

FIG. 16 is a perspective view in which the tissue suturing device of FIG. 11, after implementing a needle driving path, enables a suturing needle to extend to a puncture position.

FIG. 17 is a schematic view in which a half tube of the tissue suturing device of FIG. 16 is omitted to show an internal structure.

FIG. 18 is a schematic view in which a part of the structure of FIG. 17 is enlarged.

FIG. 19 is a schematic view in which another part of the structure of FIG. 17 is enlarged.

FIG. 20 is a perspective view schematically showing a tissue suturing device according to another embodiment of the present invention from one angle of view, in which a tube body of the tissue suturing device is removed to clearly show another kind of operating assembly.

FIG. 21 is a schematic structural diagram schematically showing a reference mark, a wing driving mark and a reference mark of a tissue suturing device according to an embodiment of the present invention.

Description of reference signs 1 -tissue suturing device, 2-operating member, 3-pin driving member, 4-wing driving member, 5-positioning member, 6-wing driving pin, 7-driving hole, 8-opening, 9-driving shaft, 10-mating slot, 11-mating port, 12-guide slide channel, 13-position retaining structure, 14-driving rod, 15-connecting rod, 16-connecting portion, 17-tube body, 18-proximal end, 19-distal end, 20- wing driving guide slot, 21 -transition guide slot, 22-needle driving guide slot, 23 -guide column, 24-half tube, 25-axial sidewall, 26-inside surface, 27-axial slot, 28-circumferential slot, 29- protruding block, 30-needle driving pin, 31-guide channel, 32-expansion slot, 33 -stabilizing wings, 34-suturing needle, 35-axial channel, 36-reference mark, 37-wing driving mark, 38-pin driving mark, 39-unlocking rotation indicator arrow, and 40-locking rotation indicator arrow.

DETAILED DESCRIPTION

The present invention will be described in detail below with reference to the accompanying drawings. The embodiments described herein are merely preferred embodiments according to the present invention, and on the basis of the preferred embodiments, those skilled in the art could conceive of other modes capable of implementing the present invention, which also fall within the scope of the present invention.

The proximal end mentioned in the present invention refers to an end of a tissue suturing device adjacent to or facing the operator when in use, and the distal end refers to an end of the tissue suturing device located away from or facing away from the operator when in use.

In a first aspect, with reference to FIGS. 1-2 and 11-17, the present invention provides an operating assembly for a tissue suturing device 1. The operating assembly includes a tube body 17, a needle driving member 3, a wing driving member 4, a positioning member 5, and an operating member 2. The tube body 17 includes a proximal end 18, a distal end 19, and an axial channel 35 extending between the proximal end 18 and the distal end 19. The needle driving member 3 is axially movably disposed within the axial channel. The wing driving member 4 is axially movably disposed within the axial channel. The positioning member 5 is connected to the wing driving member 4, and is movable in the circumferential direction relative to the wing driving member 4. At least a part of the operating member 2 is movably disposed within the axial channel and detachably engaged with the positioning member 5. The operating member 2 is movable along a wing driving path, a transition path, and a needle driving path which are sequentially implemented. In the wing driving path, the operating member 2 is not engaged with the needle driving member 3 so that the needle driving member 3 is maintained in a first position, the first position being used to cause a suturing needle in a tissue suturing state to be in a retracted state, and the operating member 2 drives, by means of the positioning member 5, the wing driving member 4 to move from a third position to a fourth position, the third position being used to cause stabilizing wings to be in a folded state, and the fourth position being used to cause the stabilizing wings to be in an unfolded state. In the transition path, the operating member 2 is rotated by a preset angle to drive the positioning member 5 to rotate to a position where the positioning member 5 and the tube body 17 are locked, so that the wing driving member 4 is maintained in the fourth position, and the operating member 2 is engaged with the needle driving member 3 and can move along the needle driving path. In the needle driving path, the operating member 2 drives the needle driving member 3 to move from the first position to a second position, the second position being used to cause the suturing needle to be in an extended state.

In the operating assembly, both the driving of the needle driving member 3 and the driving of the wing driving member 4 are implemented by means of the operating member 2, and the operating member 2 includes the wing driving path, the transition path and the needle driving path which are sequentially implemented. Hence, when in actual use, in the wing driving path, the operating member 2 can only drive the wing driving member 4 by means of the positioning member 5 but cannot drive the needle driving member 3. At the time, even if the operating member 2 is incorrectly operated or accidentally touched, the operating member 2 cannot drive the needle driving member 3 to move axially towards the distal end 19, and the suturing needle installed on the needle driving member 3 thus cannot extend out of the tube body. In this way, accidental extension of the suturing needle can be completely avoided, thereby significantly improving the safety of using the tissue suturing device. By means of the transition path, the operating member 2 is rotated by the preset angle to drive the positioning member 5 to rotate to the position where the positioning member 5 and the tube body 7 are locked, so that the wing driving member 4 is maintained in the fourth position, and the operating member 2 is engaged with the needle driving member 3 and can move along the needle driving path. In this way, in the needle driving path, the operating member 2 can drive the needle driving member 3 to move from the first position to the second position, so that the suturing needle extends out of the tube body to a puncture position.

In some embodiments of the operating assembly of the present invention, the operating member 2 may be rotated by a preset angle. At the time, the operator only needs to perform rotation once to easily know that the wing driving member 4 is maintained in the fourth position, that the operating member 2 is already in a position where it can be disengaged from the positioning member 5, and that the operating member 2 is already engaged with the needle driving member 3, and can subsequently move according to the needle driving path.

In some other embodiments, the operating member 2 may be rotated by two preset angles. For example, in the transition path, the preset angle includes a first preset angle and a second preset angle. The operating member 2 drives the positioning member 5 to rotate by the first preset angle A to lock the positioning member 5 and the tube body 17, so that the wing driving member 4 is maintained in the fourth position. When the operating member 2 continues to rotate by the second preset angle B to reach the needle driving path, the operating member 2 is disengaged from the positioning member 5 and engaged with the needle driving member 3. In this way, in the needle driving path, the operating member 2 can drive the needle driving member 3 to move from the first position to the second position, so that the suturing needle extends out of the tube body. By means of rotation by the first preset angle, the operator can easily know that the wing driving member 4 is maintained in the fourth position, and by means of rotation by the second preset angle, the operator can easily know that the operating member 2 is already disengaged from the positioning member 5 and engaged with the needle driving member 3, and can then move according to the needle driving path.

In the operating assembly of the present invention, the values of the first preset angle A and the second preset angle B may be set according to actual requirements. For example, the first preset angle A may be equal to the second preset angle B, or the first preset angle A may be greater than the second preset angle B, or the first preset angle A may be less than the second preset angle B. For example, the operator only needs to rotate by a smaller angle so that the positioning member 5 and the tube body can be locked to maintain the wing driving member in the fourth position. Subsequently, the operator rotates by a larger angle so that the operating member is disengaged from the positioning member and engaged with the needle driving member. Such an angle setting enables the operator to more clearly identify that the operating member is disengaged from the positioning member and engaged with the needle driving member. Additionally, in some embodiments, the first preset angle may be 10-30°, preferably 15-20°, more preferably 16°. The second preset angle may be 40-80°, preferably 50-70°, more preferably 60°. Of course, the first preset angle and the second preset angle may also be other angular values. In addition, the operating member 2 may be rotated clockwise or counterclockwise in the transition path.

In addition, in the operating assembly of the present invention, the detachable engagement of the operating member 2 and the positioning member 5 may be implemented in a variety of manners. No matter which manner is used, said manner is acceptable as long as the disengagement and engagement of the operating member 2 and the positioning member 5 can be implemented. For example, in one manner, the operating member 5 is provided with a pair of clamping arms pivotally disposed by means of an elastic member (e.g., a spring), and the positioning member 5 is provided with an engagement column. The pair of clamping arms detachably clamps the engagement column. When the rotational force of the operating member 2 is greater than the clamping force of the clamping arms on the engagement column, the pair of clamping arms will be opened so as to be disengaged from the engagement column, so that the operating member 2 is disengaged from the positioning member 5. In another manner, with reference to FIGS. 3, 4, 5, and 8, the operating member 2 is provided with a wing driving pin 6 thereon, and the positioning member 5 is provided with a driving hole 7. The driving hole 7 has an opening 8 the size of which is smaller than the diameter of the wing driving pin 6. The wing driving pin 6 can squeeze through the opening 8 to fit into the driving hole 7, so that the operating member 2 is engaged with the positioning member 5. In this way, the operating member 2 can drive the positioning member 5 to rotate by the first preset angle (for example, by means of rotation by the first preset angle A, transitioning from the state shown in FIG. 12 to the state shown in FIG. 14), so that the positioning member 5 and the tube body 17 are locked, and the positioning member 5 remains stationary at the time. Moreover, when the operating member 2 is rotated by the second preset angle B, since the positioning member 5 remains stationary, the continued rotation of the operating member 2 will drive the wing driving pin 6 to squeeze through the opening 8 and exit from the driving hole 7, so that the operating member 2 is disengaged from the positioning member 5 (for example, by means of rotation by the second preset angle B, transitioning from the state shown in FIG. 14 to the state shown in FIG. 15). This structure of the positioning member 5 facilitates engagement and disengagement between the operating member 2 and the positioning member 5, and also facilitates formation and installation of the positioning member 5. In addition, the edge of the opening 8 may have preset elasticity, or the wing driving pin 6 has preset elasticity, so that the wing driving pin 6 can be more easily squeezed through the opening 8. In addition, the wing driving pin 6 and the driving hole 7 may have a variety of types. No matter which type is used, said type is acceptable as long as the entry and exit described above can be implemented. For example, in some embodiments, the wing driving pin 6 may extend radially, and the driving hole 7 may be a radial hole. In this case, as shown in FIG. 4, the opening 8 may be formed on a wall in the circumferential direction of the radial hole, or the opening 8 may be formed on a wall in the axial direction of the radial hole. In this case, in order to enable the wing driving pin 6 to easily squeeze through the opening 8, the hole edge of the opening 8 may have a larger size and inclination, that is, may be formed as a splayed opening. For another example, in some embodiments, the wing driving pin 6 may include a radial segment and a circumferential segment, and a ball head is formed at the front end of the circumferential segment. The driving hole 7 may be formed as a spherical hole, and the opening 8 is formed in the circumferential direction of the spherical hole, the size of the opening 8 being less than the diameter of the ball head. In this case, the ball head can enter the spherical hole or exit from the spherical hole by squeezing through the opening 8. Furthermore, in some embodiments, the ball head has preset elasticity, so that the ball head can squeeze through the opening 8 more easily.

For another example, in some embodiments, with reference to FIG. 20, the operating member 2 is provided with a wing driving pin 6 thereon, and the positioning member 5 is provided with a driving hole 7. The driving hole 7 has an opening 8 facing the distal end 19, that is, the opening 8 is arranged toward the distal end in the axial direction of the tube body. The size of the opening 8 is smaller than the diameter of the wing drive pin 6. The wing driving pin 6 can squeeze through the opening 8 to fit into the driving hole 7 so that the operating member 2 is engaged with the positioning member 5. In the wing driving path and the transition path, the wing driving pin 6 fits into the driving hole 7. In this way, in the wing driving path, the wing driving member is not locked and can move axially toward the distal end. Therefore, when the operating member 2 drives the positioning member 5 to move axially toward the distal end, the wing driving pin 6 will not squeeze through the opening 8 to exit from the driving hole 7. At the time, the operating member 2 can drive, by means of the positioning member 5, the wing driving member to move axially toward the distal end, so as to move from the third position to the fourth position, so that the stabilizing wings are transitioned from the folded state to the unfolded state. In the transition path, the wing driving pin 6 does not squeeze through the opening 8 to exit from the driving hole 7. Therefore, the operating member 2 directly drives the positioning member 5 to rotate by a preset angle and then locks the positioning member 5, and reaches the needle driving path. In the needle driving path, the positioning member 5 is locked, and the opening 8 faces the distal end. Hence, under a force exerted by the operator, the operating member 2 causes the wing driving pin 6 to squeeze through the opening 8 to exit from the driving hole 7, so that the operating member 2 is disengaged from the positioning member 5, and drives the needle driving member 3 to move from the first position to the second position, causing the suturing needle to move from the retracted state to the extended state or puncture position.

In addition, in some embodiments, the wing driving member 4 and the positioning member 5 can be connected by means of a variety of connection structures. No matter which connection structure is used, said connection structure is acceptable as long as the positioning member 5 can be connected to the wing driving member 4, and can move in the circumferential direction relative to the wing driving member 4. For example, in some embodiments, with reference to FIGS. 3, 4, 5 and 7, the wing driving member 4 includes an axially extending driving shaft 9, and the positioning member 5 is provided with an axially extending mating slot 10. An axis of the mating slot 10 extends in the axial direction. The driving shaft 9 is mated with the mating slot 10, and the mating slot 10 has a circumferential length greater than the diameter of the driving shaft 9, so that the operating member 2 can drive the positioning member 5 along the transition path to rotate, relative to the driving shaft 9, to the position where the positioning member 5 and the tube body 17 are locked, such as rotating by the first preset angle. In addition, the mating slot 10 may be a rectangular hole or an arc-shaped hole. For example, the arc-shaped hole extends in the circumferential direction, the driving shaft 9 is mated with the arc-shaped hole, and the arc-shaped hole has an extension length greater than the diameter of the driving shaft 9. In this way, the operating member 2 can drive the positioning member 5 along the transition path to rotate by a preset angle, such as the first preset angle. Thus, the positioning member 5 and the tube body 17 are locked, so that the wing driving member 4 is maintained in the fourth position.

In addition, in some embodiments, the driving shaft 9 may be directly inserted into the mating slot 10 in the axial direction. In this case, in order to facilitate the insertion of the driving shaft 9, an engagement head having a smaller size may be formed at the proximal end of the driving shaft 9, as long as said engagement head can abut against an end surface of the positioning member 5 at the proximal end. In some embodiments, with reference to FIGS. 4 and 5, the mating slot 10 has a mating port 11 in the circumferential direction, and the driving shaft 9 fits into the mating slot 10 by means of the mating port 11. In this case, an engagement head having a larger size may be formed at the proximal end of the driving shaft 9, and the engagement head can abut against the end surface of the positioning member 5 at the proximal end, thereby allowing the driving shaft 9 to be installed in the mating slot 10 more stably and reliably. In addition, when the wing driving pin 6 squeezes through the opening 8 and exits from the driving hole 7, the driving shaft 9 is still maintained in the mating slot 10.

In addition, in some embodiments, one positioning member 5 may be provided, and for example, one wing driving pin 6 may be correspondingly provided. In some embodiments, a plurality of positioning members 5 may be provided. For example, with reference to FIG. 3, the operating assembly includes at least two positioning members 5 circumferentially spaced apart from each other. The at least two positioning members 5 can simultaneously be engaged with or disengaged from the operating member 2, and the at least two positioning members 5 cooperate with the wing driving member 4, and can simultaneously move in the circumferential direction relative to the wing driving member. In this way, more stable and reliable driving by the operating member 2, and more stable and reliable axial movement of the wing driving member 4 can be implemented. For example, in some embodiments, two positioning members 5 may be provided, and a driving hole 7 and a mating slot 10 are formed on each positioning member 5. Two wing driving pins 6 are formed on the operating member 2, and each of the two wing driving pins 6 is detachably engaged with a driving hole 7 corresponding thereto. The wing driving member 4 includes two driving shafts 9, and each driving shaft 9 is mated with a mating slot 10 corresponding thereto.

In addition, in some embodiments, with reference to FIGS. 9, 10 and 12, a guide slide channel 12 for the wing driving member 4 to pass through is formed on the needle driving member

3. By means of this guide action between the guide slide channel 12 and the wing driving member

4, the stability of the axial movement of the wing driving member 7 and the needle driving member 3 can be further improved, and the unfolding of the stabilizing wings and the extension of the suturing needle can be more smoothly driven.

In addition, in some embodiments, with reference to FIGS. 9 and 10, a position retaining structure 13 is provided on the needle driving member 3, and when the needle driving member 3 is moved to the second position, the position retaining structure 13 cooperates with the tube body 17 to be in a stop state to block the needle driving member 3 from continuing to move axially, so that the needle driving member 3 is maintained in the second position. In this way, the needle driving member 3 can be accurately and reliably positioned to the second position, so that the suturing needle can accurately extend to the desired position. In addition, the position retaining structure 13 may have a variety of types. For example, for one type, the position retaining structure 13 may be a recess, and an elastic column (not shown) such as a rubber column or a column connected with a spring is formed in a corresponding location on the inner sidewall of the tube body 17, and the elastic column may extend into the recess. Alternatively, for another type, the position retaining structure 13 may be an elastic column, and a recess is formed in a corresponding location on the inner sidewall of the tube body 17, and the elastic column may extend into the recess. In addition, in some embodiments, the position retaining structure 13 may be a column, and a recess having a smaller depth is formed in a corresponding location on the inner sidewall of the tube body 17. In this case, after an end portion of the column is positioned within the recess, the friction force between the column and the recess can position the needle driving member 3 to the second position.

In addition, in some embodiments, with reference to FIG. 19, when the needle driving member 3 is moved to the second position, the wing driving member 4 in the fourth position blocks the needle driving member 3 from continuing to move axially. In this way, the needle driving member 3 can be accurately and reliably positioned to the second position, so that the suturing needle can accurately extend to the desired position. Meanwhile, the needle driving member 3 maintained in the second position blocks the wing driving member 4 from returning, so that accidental folding of the wing driving member can be completely prevented, thereby reliably maintaining the stabilizing wings in the unfolded position.

In addition, in the operating assembly of the present invention, the wing driving member 4 may have a variety of structural forms. No matter which structural form is used, said structural form is acceptable as long as the function of the wing driving member 4 can be implemented. For example, in some embodiments, with reference to FIGS. 2, 3 and 7, the wing driving member 4 includes a driving rod 14, and two connecting rods 15 circumferentially spaced apart from each other. Distal ends of the two connecting rods 15 are connected by means of a connecting portion 16, and the driving rod 14 is connected to the connecting portion 16 and extends toward a distal end of the operating assembly to be hinged to the stabilizing wings. Each of the connecting rods 15 is connected to a positioning member 5 corresponding thereto. In this way, the two connecting rods 15 and the two positioning members 5 form two sets of connection structures, so that the axial movement of the wing driving member 4 can be smoother. In addition, in some embodiments, a driving shaft 9 is formed at the proximal end of each connecting rod 15, and is mated with the mating slot 10 of the corresponding positioning member 5.

In addition, in some embodiments, with reference to FIGS. 7, 9, 10 and 12, axially extending guide slide channels 12 are formed on at least two opposing side portions of the needle driving member 3, respectively, and the two connecting rods 15 axially pass through the guide slide channels 12 corresponding thereto, respectively. For example, in some embodiments, the needle driving member 3 is installed between the two connecting rods 15, and the two connecting rods 15 axially pass through the respective corresponding guide slide channels 12. In this way, by means of this guide action between the two guide slide channels 12 and the two connecting rods 15, the stability of the axial movement of the wing driving member 7 and the needle driving member 3 can be further improved, and the unfolding of the stabilizing wings and the extension of the suturing needle can be more smoothly driven.

In addition, in some embodiments, with reference to FIGS. 17 and 19, when the needle driving member 3 is moved to the second position, the connecting portion 16 of the wing driving member 4 in the fourth position contacts a bottom portion of the needle driving member 3 to block the needle driving member 3 from continuing to move axially. In this way, the needle driving member 3 can be accurately and reliably positioned to the second position, so that the suturing needle can accurately extend to the desired position.

In the operating assembly of the present invention, in some embodiments, the wing driving path, the transition path, and the needle driving path are formed between the operating member and the wing driving member 4 and the needle driving member 3. In this case, the operating member can be rotated in all of the wing driving path, the transition path, and the needle driving path. For example, in the wing driving path, the operating member is rotated by a predetermined angle, so as to drive the wing driving member 4 to move from the third position to the fourth position by means of a cam or a tapered profile between the operating member and the wing driving member 4. At the time, the wing driving member is maintained in the fourth position while the operating member and the needle driving member (which may be mated by means of a circumferential sliding slot and a column between the two, for example) are maintained to be in relative rotation to disengage, so that the needle driving member is maintained in the first position. In the transition path, the operating member is rotated so that the operating member is disengaged from the positioning member and engaged with the needle driving member. In the needle driving path, the operating member continues to rotate by a predetermined angle, so as to drive the needle driving member to move from the first position to the second position by means of a cam or tapered profile between the operating member and the needle driving member.

In the operating assembly of the present invention, in some embodiments, with reference to FIGS. 3, 6, 12-15, 17 and 18, the wing driving path, the transition path, and the needle driving path are formed between the tube body 17 and the operating member 2. The wing driving path extends toward the proximal end 18 and along the axial direction, the needle driving path extends toward the distal end 19 and along the axial direction, and the transition path is arranged in the circumferential direction of the tube body 17, so that the operating member 2 can move axially along the wing driving path, then rotate along the transition path by the preset angle (for example, in some embodiments, rotating by the first preset angle and the second preset angle) and then reach the needle driving path, and then move axially along the needle driving path. For example, during extension of the needle, the operating member first performs a first axial movement to complete the wing driving path, then performs two rotations to complete the transition path, and finally performs one axial movement to complete the needle driving path. In this way, the transition path separates the wing driving path and the needle driving path, and the operating member cannot implement the needle driving path when implementing the wing driving path, thereby completely avoiding accidental extension of the suturing needle.

The wing driving path, the transition path, and the needle driving path between the tube body 17 and the operating member 2 may be implemented in a variety of manners. For example, in some embodiments, with reference to FIGS. 3, 6, 12-15, 17 and 18, a wing driving guide slot 20 providing the wing driving path, a transition guide slot 21 providing the transition path, and a needle driving guide slot 22 providing the needle driving path are formed on an axial sidewall of the tube body 17, wherein a guide column 23 is provided on the operating member 2, and the guide column 23 is movable along the wing driving guide slot 20, the transition guide slot 21, and the needle driving guide slot 22. In this way, the guide column 23 will not be able to move in the needle driving guide slot 22 when the guide column moves along the wing driving guide slot 20. Therefore, the operating member can only implement the wing driving path but cannot implement the needle driving path, so that only the stabilizing wings can be unfolded but the suturing needle is unable to extend out, thereby completely avoiding accidental extension of the suturing needle. Only when the guide column 23 is moved to the needle driving guide slot 22 along the transition guide slot 21, can the further axial movement of the operating member drive the needle driving member to move axially to extend the suturing needle out of the tube body. In addition, the wing driving guide slot, the transition guide slot, and the needle driving guide slot may be recesses formed on the inner surface of a sidewall of the tube body, or the wing driving guide slot, the transition guide slot, and the needle driving guide slot may be through-channels formed on the sidewall of the tube body and penetrating the thickness of the sidewall. In addition, in an alternative embodiment, the wing driving guide slot, the transition guide slot, and the needle driving guide slot may be formed on the operating member, whereas the guide column may be formed on the inner surface of the sidewall of the tube body.

In addition, in some embodiments, in order to improve the convenience of installation and easy processing of the operating assembly, with reference to FIGS. 1, 2 and 3, the tube body 17 includes at least two half tubes 24 which can be joined together, wherein a set of the wing driving path, the transition path, and the needle driving path is formed on the at least two half tubes 24. For example, when two half tubes are provided, the wing driving path is formed on one half tube, the transition path is formed on both half tubes, that is, one part of the transition path is formed on one half tube, and the other part of the transition path is formed on the other half tube, and the needle driving path is formed on the other half tube.

In addition, in some embodiments, in order to improve the stability of operation of the operating member 2 to easily drive the wing driving member and the needle driving member, with reference to FIGS. 3 and 18, two sets of the wing driving guide slot 20, the transition guide slot 21, and the needle driving guide slot 22 are formed on the at least two half tubes 24. At least two guide columns 23 are provided on the operating member 2, and each of the guide columns 23 is movable along a set of the wing driving guide slot 20, the transition guide slot 21, and the needle driving guide slot 22 corresponding thereto. In this way, two sets of guide slots guide two guide columns 23, so that the operation of the operating member 2 can be smoother and more reliable. Furthermore, in some alternative embodiments, the tube body 17 includes at least two half tubes 24 that can be joined together, wherein a set of the wing driving path, the transition path and the needle driving path is formed on one of the half tubes (24), so that a set of the wing driving path, the transition path and the needle driving path can be easily formed on the inside surface of one half tube.

In addition, in some embodiments, in order to improve the stability of operation of the operating member 2 to easily drive the wing driving member and the needle driving member, a set of the wing driving guide slot 20, the transition guide slot 21 and the needle driving guide slot 22 is formed on each half tube 24, at least two guide columns 23 are provided on the operating member 2, and each guide column 23 is movable along the wing driving guide slot 20, the transition guide slot 21, and the needle driving guide slot 22 of a half tube corresponding thereto. In this way, two sets of guide slots guide two guide columns 23, so that the operation of the operating member 2 can be smoother and more reliable.

In addition, in some embodiments, with reference to FIGS. 4, 5 and 6, an axial slot 27 and a circumferential slot 28 in communication with each other are formed on one of an inside surface 26 of an axial sidewall 25 of the tube body 17 and the positioning member 5, and a protruding block 29 is formed on the other of the inside surface and the positioning member. When the operating member 2 moves axially along the wing driving path from an initial position to the transition path, the protruding block 29 and the axial slot 27 are axially and slidably mated relative to each other to guide the axial movement of the positioning member 5. When the operating member 2 drives the positioning member 5 to rotate along the transition path until the protruding block 29 is mated with the circumferential slot 28, the positioning member 5 is locked to the tube body 17 to be in a locked position. For example, the operating member 2 drives the positioning member 5 along the transition path to rotate by the first preset angle, or is rotated by a preset angle. In this way, the circumferential slot 28 blocks the positioning member 5 from moving axially, thereby maintaining the wing driving member in the fourth position.

For example, in the embodiment shown in FIG. 6, the axial slot 27 and the circumferential slot 28 are formed on the tube body 17. In some embodiments, the axial slot 27 and the circumferential slot 28 may be a recessed slot formed on the inner surface of the tube body 17, that is, the slot does not penetrate the wall thickness of the tube body 17 in the radial direction. 1 Alternatively, in other embodiments, the axial slot 27 and the circumferential slot 28 may be a radial through-slot penetrating the wall thickness of the tube body 17 in the radial direction. In this way, the operator can observe the position of the protruding block 29 from the outside of the tube body 17, thereby making it possible to identify whether the wing driving path and the transition path are completed or not.

In addition, in the operating assembly of the present invention, the needle driving member 3 may have a variety of structural forms. No matter which structural form is used for the needle driving member 3, said structural form is acceptable as long as the above function can be implemented. For example, in some embodiments, with reference to FIGS. 6, 9, 10, 14 and 15, a needle driving pin 30 extending radially outwards is formed on the operating member 2, an axially extending guide channel 31 is formed on an end surface of the needle driving member 3 facing the operating member 2, and an expansion slot 32 extending radially outwards is formed on an inner surface of the guide channel 31 at a predetermined position. When the operating member 2 moves axially along the wing driving path to the transition path, the needle driving pin 30 moves axially along the guide channel 31 to the expansion slot 32, so that the operating member 2 remains disengaged from the needle driving member 3. In this way, in the wing drive path, the needle driving member 3 will remain in the first position. When the operating member 2 is rotated to the needle driving path along the transition path, the needle driving pin 30 enters and fits into the expansion slot 32, so that the operating member 2 is engaged with the needle driving member 3. In this way, in the needle driving path, the operating member 2 will drive the needle driving member 3 to move axially.

In addition, in some embodiments, one needle driving pin 30 and one expansion slot 32 may be provided. In addition, in some embodiments, two needle driving pins 30 are provided and are circumferentially spaced apart, and two expansion slots 32 are provided and are circumferentially spaced apart, wherein the two needle driving pins 30 can simultaneously enter and fit into the respective expansion slots 32 corresponding thereto, and can simultaneously exit from the respective expansion slots 32 corresponding thereto. In this way, by means of two needle driving pins 30 and two expansion slots 32, the stability of driving the needle driving member by the operating member can be further improved. In addition, in some embodiments, in order to improve the operability of the operating assembly and further enable the operator to quickly identify the wing driving path, the transition path, and the needle driving path of the operating member, with reference to FIG. 21, a reference mark 36 is provided on one of the operating member 2 and the tube body 17, and a wing driving mark 37 and a needle driving mark 38 circumferentially spaced apart at a preset angle are provided on the other of the operating member and the tube body. A region between the wing driving mark 37 and the needle driving mark 38 is the transition path. In some embodiments, the wing driving mark 37 may be different from the needle driving mark 38, or, in some embodiments, the wing driving mark 37 may be the same as the needle driving mark 38. When the wing driving mark 37 and the reference mark 36 are axially aligned, the operating member 2 can axially move from an initial position toward the distal end along the wing driving path, so as to unfold the stabilizing wings. When the operating member 2 is rotated along the transition path to the needle driving path, the needle driving mark 38 and the reference mark 36 are axially aligned. At the time, the operating member 2 can be moved axially toward the distal end, so that the suturing needle extends to the puncture position. In this way, the operator can quickly identify which path the operating member is in, so as to perform corresponding operations in sequence. For example, when the operator identifies that the operating member 2 is in the needle driving path, the operating member 2 can be pushed toward the distal end, so that the suturing needle extends out of the tube body 17 to the puncture position. In addition, in some embodiments, in order to further improve identifiability, the wing driving mark and the needle driving mark may have different colors. For example, the wing driving mark is blue, the needle driving mark is red, and the reference mark may be red.

In addition, it should be noted that the reference mark 36, the wing driving mark 37, and the needle driving mark 38 have, but are not limited to, the structural form shown in FIG. 21. In the embodiment shown in FIG. 21, the reference mark 36 may be a remaining outer peripheral surface after a part of the proximal end of the operating member 2 is cut away, and the wing driving mark 37 and the needle driving mark 38 may be a first protrusion and a second protrusion circumferentially spaced apart and radially extending on the proximal end surface of the tube body 17, respectively. In this case, when the axial centerline of the remaining outer peripheral surface is axially aligned with the first protrusion, the operating member 2 may be axially moved toward the distal end to implement the wing driving path, and then the operating member 2 is rotated to implement the transition path. When the axial centerline of the remaining outer peripheral face is axially aligned with the second protrusion, the operating member 2 may be axially moved toward the distal end to implement the needle driving path.

In addition, in some embodiments, the reference mark 36 may be formed on the end surface of the operating member 2 at the proximal end, and the wing driving mark 37 and the needle driving mark 38 may be formed on the outer peripheral surface of the tube body 17.

Furthermore, in some embodiments, with reference to FIG. 21, an unlocking rotation indicator arrow 39 and a locking rotation indicator arrow 40 are provided on an end surface of the operating member 2 at the proximal end. In this way, when the wing driving mark 37 and the reference mark 36 are axially aligned, the operating member 2 can axially move from an initial position along the wing driving pat toward the distal end, so as to unfold the stabilizing wings. Subsequently, the operator may rotate the operating member 2 in accordance with the arrow indicating direction of the locking rotation indicator arrow 40 to implement and complete the transition path, so that the reference mark 36 and the needle driving mark 38 are axially aligned. At the time, the operating member 2 can be moved axially toward the distal end to implement and complete the needle driving path, so that the suturing needle extends to the puncture position. In addition, when retraction is required, the operating member 2 can be moved axially toward the proximal end to implement and complete the needle driving path, so as to retract the suturing needle back into the tube body. Subsequently, the operator can rotate the operating member 2 in accordance with the arrow indicating direction of the unlocking rotation indicator arrow 39 to implement and complete the transition path, so that the reference mark 36 and the wing driving mark 37 are axially aligned. Then, the operating member 2 can be moved axially toward the proximal end to implement and complete the wing driving path, so as to fold the stabilizing wings. In this way, the operator can quickly identify which path the operating member is in, so as to perform corresponding operations in sequence.

In a second aspect, the present invention provides a tissue suturing device 1. With reference to FIGS. 1-19, the tissue suturing device 1 includes the operating assembly according to any of the foregoing described in the first aspect, stabilizing wings 33, and a suturing needle 34. The stabilizing wings 33 are hinged to the distal end 19 of the tube body 17 and hinged to the wing driving member 4 (e.g., the driving rod 14). The suturing needle 34 is disposed on the needle driving member 3 and located in the tube body 17. The stabilizing wings 33 can be unfolded and folded, and the suturing needle 34 can extend out of the tube body 17 to a puncture position, and can retract back into the tube body 17. In this way, as described in the first aspect above, by means of the operating assembly, the tissue suturing device can completely avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device.

In a third aspect, the present invention provides an operating method of a tissue suturing device. The operating method includes: configuring an operating member of a tissue suturing device to have a wing driving path, a transition path, and a needle driving path which are sequentially implemented, wherein in the wing driving path, the operating member moves from an initial position along the wing driving path to the transition path, so that the operating member drives a wing driving member to move from a third position to a fourth position by means of driving a positioning member of the tissue suturing device, so as to unfold stabilizing wings of the tissue suturing device; in the transition path, the operating member is driven to rotate by a preset angle along the transition path, so that the positioning member is locked to a tube body of the tissue suturing device to maintain the wing driving member in the fourth position, and the operating member is engaged with a needle driving member of the tissue suturing device and is movable along the needle driving path; and in the needle driving path, the operating member is driven to drive the needle driving member to move from a first position to a second position, so as to drive a suturing needle to extend out of the tube body of the tissue suturing device to a puncture position.

In the operating method, in the wing driving path, the operating member can only drive the wing driving member by means of the positioning member but cannot drive the needle driving member. At the time, even if the operating member is incorrectly operated or accidentally touched, the operating member cannot drive the needle driving member to move axially, and the suturing needle installed on the needle driving member thus cannot extend out of the tube body. In this way, accidental extension of the suturing needle can be completely avoided, thereby significantly improving the safety of using the tissue suturing device. By means of the transition path, the positioning member and the tube body of the tissue suturing device are locked to maintain the wing driving member in the fourth position, and the operating member is engaged with the needle driving member of the tissue suturing device and can move along the needle driving path. In this way, in the needle driving path, the operating member can drive the needle driving member to move from the first position to the second position, so that the suturing needle extends out of the tube body. When the stabilizing wings and the suturing needle need to be retracted, the steps are simply performed reversely in sequence.

In the transition path, the operating member is driven to drive the positioning member to rotate by a first preset angle along the transition path, so that the positioning member is locked to the tube body of the tissue suturing device to maintain the wing driving member in the fourth position. The operating member is driven to continue to rotate by a second preset angle along the transition path to reach the needle driving path, so that the operating member is disengaged from the positioning member and engaged with the needle driving member of the tissue suturing device. In the needle driving path, the operating member is driven to drive the needle driving member to move from a first position to a second position, so as to drive a suturing needle to extend out of the tube body of the tissue suturing device to a puncture position.

In the operating method, in the wing driving path, the operating member can only drive the wing driving member by means of the positioning member but cannot drive the needle driving member. At the time, even if the operating member is incorrectly operated or accidentally touched, the operating member cannot drive the needle driving member to move axially, and the suturing needle installed on the needle driving member thus cannot extend out of the tube body. In this way, accidental extension of the suturing needle can be completely avoided, thereby significantly improving the safety of using the tissue suturing device. By means of the transition path, the operating member drives the positioning member to rotate by the first preset angle, so that the positioning member is locked to the tube body to maintain the wing driving member in the fourth position. Then, when the operating member continues to rotate by the second preset angle to reach the needle driving path, the operating member is disengaged from the positioning member and engaged with the needle driving member. In this way, in the needle driving path, the operating member can drive the needle driving member to move from the first position to the second position, so that the suturing needle extends out of the tube body. When the stabilizing wings and the suturing needle need to be retracted, the operations are simply performed reversely in sequence.

In addition, in some embodiments, the operating member is driven to move axially along the wing driving path, and the operating member is driven to move axially along the needle driving path. In this way, during extension of the needle, the operating member first performs a first axial movement to complete the wing driving path, then performs two rotations to complete the transition path, and finally performs one axial movement to complete the needle driving path. In this way, the transition path separates the wing driving path and the needle driving path, and the operating member cannot implement the needle driving path when implementing the wing driving path, thereby completely avoiding accidental extension of the suturing needle. In addition, such an arrangement enables an operator to effectively identify each driving path.

In addition, when the tissue suturing device needs to be retracted, the operating member can be driven reversely along the needle driving path to drive the needle driving member to move from the second position to the first position, so as to drive the suturing needle to retract into the tube body. Subsequently, the operating member can be driven reversely along the transition path to rotate by a preset angle, so that the positioning member is unlocked from the tube body of the tissue suturing device are unlocked, and the operating member is disengaged from the needle driving member. Finally, the operating member can be driven reversely along the wing driving path to drive the wing driving member to move from the fourth position to the third position, so as to fold the stabilizing wings. That is, the operations are simply performed reversely.

In a fourth aspect, the present invention provides a tissue suturing device capable of implementing the operating method of a tissue suturing device according to any of the foregoing described in the third aspect above. In this way, as described above, the tissue suturing device can completely avoid accidental extension of the suturing needle, thereby significantly improving the safety of using the tissue suturing device.

The scope of protection of the present invention is defined only by the claims. In light of the teachings of the present invention, those skilled in the art would readily recognize that alternative structures of the structures disclosed in the present invention may be used as feasible alternative embodiments, and the embodiments disclosed in the present invention may be combined to form new embodiments, which also fall within the scope of the appended claims.

Claims

1. An operating assembly for a tissue suturing device (1), characterized in that the operating assembly comprises: a tube body (17), the tube body (17) comprising a proximal end (18), a distal end (19), and an axial channel (35) extending between the proximal end (18) and the distal end (19); a needle driving member (3), the needle driving member (3) being axially movably disposed within the axial channel; a wing driving member (4), the wing driving member (4) being axially movably disposed within the axial channel; a positioning member (5), the positioning member (5) being connected to the wing driving member (4) and being movable in the circumferential direction relative to the wing driving member (4); and an operating member (2), at least a part of the operating member (2) being movably disposed within the axial channel and detachably engaged with the positioning member (5); wherein the operating member (2) is movable along a wing driving path, a transition path, and a needle driving path which are sequentially implemented; in the wing driving path, the operating member (2) is not engaged with the needle driving member (3) so that the needle driving member (3) is maintained in a first position, the first position being used to cause a suturing needle in a tissue suturing state to be in a retracted state, and the operating member (2) drives, by means of the positioning member (5), the wing driving member (4) to move from a third position to a fourth position, the third position being used to cause stabilizing wings to be in a folded state, and the fourth position being used to cause the stabilizing wings to be in an unfolded state; and in the transition path, the operating member (2) is rotated by a preset angle to drive the positioning member (5) to rotate to a position where the positioning member (5) and the tube body (17) are locked, so that the wing driving member (4) is maintained in the fourth position, and the operating member (2) is engaged with the needle driving member (3) and is movable along the needle driving path; and in the needle driving path, the operating member (2) drives the needle driving member (3) to move from the first position to a second position, the second position being used to cause the suturing needle to be in an extended state.

2. The operating assembly according to claim 1, wherein in the transition path, the preset angle comprises a first preset angle and a second preset angle, wherein the operating member (2) drives the positioning member (5) to rotate by the first preset angle to lock the positioning member (5) and the tube body (17), so that the wing driving member (4) is maintained in the fourth position; and when the operating member (2) continues to rotate by the second preset angle to reach the needle driving path, the operating member (2) is disengaged from the positioning member (5) and engaged with the needle driving member (3).

3. The operating assembly according to claim 2, wherein the first preset angle is less than or equal to the second preset angle.

4. The operating assembly according to claim 2, wherein the operating member (2) is provided with a wing driving pin (6) thereon, the positioning member (5) is provided with a driving hole (7), the driving hole (7) has an opening (8) the size of which is smaller than the diameter of the wing driving pin (6), and the wing driving pin (6) can squeeze through the opening (8) to fit into the driving hole (7) so that the operating member (2) is engaged with the positioning member

(5), so as to enable the operating member (2) to drive the positioning member (5) to rotate by the first preset angle; and when the operating member (2) is rotated by the second preset angle, the wing driving pin

(6) squeezes through the opening (8) and exits from the driving hole (7), so that the operating member (2) is disengaged from the positioning member (5).

5. The operating assembly according to claim 1, wherein the operating member (2) is provided with a wing driving pin (6) thereon, the positioning member (5) is provided with a driving hole (7), the driving hole (7) has an opening (8) facing the distal end (19), and the size of the opening (8) is smaller than the diameter of the wing driving pin (6), wherein the wing driving pin (6) can squeeze through the opening (8) to fit into the driving hole (7) so that the operating member (2) is engaged with the positioning member (5), wherein in the wing driving path and the transition path, the wing driving pin (6) fits into the driving hole (7), and in the needle driving path, the wing driving pin (6) squeezes through the opening (8) to exit from the driving hole (7), so that the operating member (2) is disengaged from the positioning member (5).

6. The operating assembly according to claim 1, wherein the wing driving member (4) comprises an axially extending driving shaft (9), the positioning member (5) is provided with an axially extending mating slot (10), the driving shaft (9) is mated with the mating slot (10), and the mating slot (10) has a circumferential length greater than the diameter of the driving shaft (9), so that the operating member (2) can drive the positioning member (5) along the transition path to rotate, relative to the driving shaft (9), to the position where the positioning member (5) and the tube body (17) are locked.

7. The operating assembly according to claim 6, wherein the mating slot (10) is provided with a mating port (11) in the circumferential direction, and the driving shaft (9) fits into the mating slot (10) by means of the mating port (11).

8. The operating assembly according to claim 1, wherein the operating assembly comprises at least two positioning members (5) circumferentially spaced apart from each other, the at least two positioning members (5) can simultaneously be engaged with or disengaged from the operating member (2), and the at least two positioning members (5) cooperate with the wing driving member (4) and can simultaneously move in the circumferential direction relative to the wing driving member.

9. The operating assembly according to claim 1, wherein a guide slide channel (12) for the wing driving member (4) to pass through is formed on the needle driving member (3).

10. The operating assembly according to claim 1, wherein a position retaining structure (13) is provided on the needle driving member (3), and when the needle driving member (3) is moved to the second position, the position retaining structure (13) cooperates with the tube body (17) to be in a stop state to block the needle driving member (3) from continuing to move axially, so that the needle driving member (3) is maintained in the second position.

11. The operating assembly according to claim 1, wherein when the needle driving member (3) is moved to the second position, the wing driving member (4) in the fourth position blocks the needle driving member (3) from continuing to move axially while the needle driving member (3) maintained in the second position blocks the wing driving member (4) from returning.

12. The operating assembly according to claim 1, wherein the wing driving member (4) comprises a driving rod (14) and two connecting rods (15) circumferentially spaced apart from each other, wherein distal ends of the two connecting rods (15) are connected by means of a connecting portion (16), and the driving rod (14) is connected to the connecting portion (16) and extends toward a distal end of the operating assembly, wherein each of the connecting rods (15) is connected to a positioning member (5) corresponding thereto.

13. The operating assembly according to claim 12, wherein axially extending guide slide channels (12) are formed on at least two opposing side portions of the needle driving member (3), and the two connecting rods (15) axially pass through the guide slide channels (12) corresponding thereto, respectively.

14. The operating assembly according to claim 12, wherein when the needle driving member (3) is moved to the second position, the connecting portion (16) of the wing driving member (4) in the fourth position contacts a bottom portion of the needle driving member (3) to block the needle driving member (3) from continuing to move axially.

15. The operating assembly according to claim 1, wherein the wing driving path, the transition path, and the needle driving path are formed between the tube body (17) and the operating member (2), wherein the wing driving path extends toward the proximal end (18) and along the axial direction, the needle driving path extends toward the distal end (19) and along the axial direction, and the transition path is arranged in the circumferential direction of the tube body (17), so that the operating member (2) can move axially along the wing driving path, then rotate along the transition path by the preset angle and then reach the needle driving path, and then move axially along the needle driving path.

16. The operating assembly according to claim 15, wherein a wing driving guide slot (20) providing the wing driving path, a transition guide slot (21) providing the transition path, and a needle driving guide slot (22) providing the needle driving path are formed on an axial sidewall of the tube body (17), wherein a guide column (23) is provided on the operating member (2), and the guide column (23) is movable along the wing driving guide slot (20), the transition guide slot (21), and the needle driving guide slot (22).

17. The operating assembly according to claim 15 or 16, wherein the tube body (17) comprises at least two half tubes (24) which can be joined together, wherein a set of the wing driving path, the transition path, and the needle driving path is formed on the at least two half tubes (24).

18. The operating assembly according to claim 17, wherein two sets of the wing driving guide slot (20), the transition guide slot (21), and the needle driving guide slot (22) are formed on the at least two half tubes (24); wherein at least two guide columns (23) are provided on the operating member (2), and each of the guide columns (23) is movable along a set of the wing driving guide slot (20), the transition guide slot (21), and the needle driving guide slot (22) corresponding thereto.

19. The operating assembly according to claim 15 or 16, wherein the tube body (17) comprises at least two half tubes (24) which can be joined together, wherein a set of the wing driving path, the transition path, and the needle driving path is formed on one of the half tubes (24).

20. The operating assembly according to claim 19, wherein a set of the wing driving guide slot (20), the transition guide slot (21), and the needle driving guide slot (22) is formed on each of the half tubes (24), at least two guide columns (23) are provided on the operating member (2), and each of the guide columns (23) is movable along the wing driving guide slot (20), the transition guide slot (21), and the needle driving guide slot (22) of a half tube corresponding thereto.

21. The operating assembly according to claim 15, wherein an axial slot (27) and a circumferential slot (28) in communication with each other are formed on one of an inside surface (26) of an axial sidewall (25) of the tube body (17) and the positioning member (5), and a protruding block (29) is formed on the other of the inner surface and the positioning member, wherein when the operating member (2) moves axially along the wing driving path from an initial position to the transition path, the protruding block (29) and the axial slot (27) are axially and slidably mated relative to each other; and when the operating member (2) drives the positioning member (5) to rotate along the transition path until the protruding block (29) is mated with the circumferential slot (28), the positioning member (5) is locked to the tube body (17) to be in a locked position.

22. The operating assembly according to claim 15, wherein a needle driving pin (30) extending radially outwards is formed on the operating member (2), an axially extending guide channel (31) is formed on an end surface of the needle driving member (3) facing the operating member (2), and an expansion slot (32) extending radially outwards is formed on an inner surface of the guide channel (31) at a predetermined position, wherein when the operating member (2) moves axially along the wing driving path to the transition path, the needle driving pin (30) moves axially along the guide channel (31) to the expansion slot (32), so that the operating member (2) remains disengaged from the needle driving member (3); and when the operating member (2) is rotated to the needle driving path along the transition path, the needle driving pin (30) enters and fits into the expansion slot (32), so that the operating member (2) is engaged with the needle driving member (3).

23. The operating assembly according to claim 22, wherein two needle driving pins (30) are provided and are circumferentially spaced apart, and two expansion slots (32) are provided and are circumferentially spaced apart, wherein the two needle driving pins (30) can simultaneously enter and fit into the respective expansion slots (32) corresponding thereto, and can simultaneously exit from the respective expansion slots (32) corresponding thereto.

24. The operating assembly according to claim 15, wherein a reference mark (36) is provided on one of the operating member (2) and the tube body (17), and a wing driving mark (37) and a needle driving mark (38) circumferentially spaced apart at a preset angle are provided on the other of the operating member and the tube body (17), wherein when the wing driving mark (37) and the reference mark (36) are axially aligned, the operating member (2) can axially move from an initial position along the wing driving path; and when the operating member (2) is rotated to the needle driving path along the transition path, the needle driving mark (38) and the reference mark (36) are axially aligned.

25. The operating assembly according to claim 24, wherein an unlocking rotation indicator arrow (39) and a locking rotation indicator arrow (40) are provided on an end surface of the operating member (2) at a proximal end.

26. A tissue suturing device, characterized by comprising: the operating assembly according to any one of claims 1 to 25; stabilizing wings (33), the stabilizing wings (33) being hinged to the distal end (19) of the tube body (17) and being hinged to the wing driving member (4); and a suturing needle (34), the suturing needle (34) being disposed on the needle driving member (3) and being located in the tube body (17); wherein the stabilizing wings (33) can be unfolded and folded, and the suturing needle (34) can extend from within the tube body (17) to a puncture position and can retract back into the tube body (17).

27. An operating method of a tissue suturing device, characterized by comprising: an operating member of a tissue suturing device being provided with a wing driving path, a transition path, and a needle driving path which are sequentially implemented, wherein in the wing driving path, the operating member moves from an initial position along the wing driving path to the transition path, so that the operating member drives a wing driving member to move from a third position to a fourth position by means of driving a positioning member of the tissue suturing device, so as to unfold stabilizing wings of the tissue suturing device; in the transition path, the operating member is driven to rotate by a preset angle along the transition path, so that the positioning member is locked to a tube body of the tissue suturing device to maintain the wing driving member in the fourth position, and the operating member is engaged with a needle driving member of the tissue suturing device and is movable along the needle driving path; and in the needle driving path, the operating member is driven to drive the needle driving member to move from a first position to a second position, so as to drive a suturing needle to extend out of the tube body of the tissue suturing device to a puncture position.

28. The operating method of a tissue suturing device according to claim 27, wherein in the transition path, the operating member is driven to drive the positioning member to rotate by a first preset angle along the transition path, so that the positioning member is locked to the tube body to maintain the wing driving member in the fourth position; and the operating member is driven to continue to rotate by a second preset angle along the transition path to reach the needle driving path, so that the operating member is disengaged from the positioning member and engaged with the needle driving member.

29. The operating method of a tissue suturing device according to claim 27, wherein the operating member is driven to move axially along the wing driving path, and the operating member is driven to move axially along the needle driving path.

30. The operating method of a tissue suturing device according to claim 27, wherein the operating member is driven reversely along the needle driving path to drive the needle driving member to move from the second position to the first position, so as to drive the suturing needle to retract back into the tube body; the operating member is driven reversely along the transition path to rotate by a preset angle, so that the positioning member is unlocked from the tube body of the tissue suturing device, and the operating member is disengaged from the needle driving member; and the operating member is driven reversely along the wing driving path to drive the wing driving member to move from the fourth position to the third position, so as to fold the stabilizing wings.

31. A tissue suturing device, characterized in that: the tissue suturing device is capable of implementing the operating method of a tissue suturing device according to any one of claims 27 to 30.