CN117159067A

CN117159067A - Medical stitching instrument and actuating mechanism thereof

Info

Publication number: CN117159067A
Application number: CN202311042275.7A
Authority: CN
Inventors: 孙书琪; 请求不公布姓名; 贾英伟; 韩强
Original assignee: Suzhou Frankman Medical Device Technology Research Institute Co ltd
Current assignee: Suzhou Frankman Medical Device Technology Research Institute Co ltd
Priority date: 2023-08-18
Filing date: 2023-08-18
Publication date: 2023-12-05

Abstract

The invention provides a medical suture device and an actuating mechanism thereof. The actuating mechanism comprises a first clamping member, a second clamping member, a nail pushing piece, a locking assembly, a membrane assembly and a flexible member connected between the locking assembly and the nail pushing piece, wherein the locking assembly comprises a locking sliding block; the membrane component comprises a membrane positioned between the first clamping component and the second clamping component, a far-end connecting piece and a near-end connecting piece, wherein the two ends of the far-end connecting piece are connected to the far-end part of the membrane and enclose the first clamping component between the far-end part and the membrane, the near-end connecting piece comprises a first near-end branch and a second near-end branch, one ends of the first near-end branch and the second near-end branch are connected to the near-end part of the membrane, and the other ends of the first near-end branch and the second near-end branch are connected through a locking sliding block and enclose the first clamping component between the first clamping component and the membrane; as the pusher slides distally, the pusher pulls the flexible member with the locking sled sliding proximally to disconnect the first proximal leg and the second proximal leg. The membrane component of the actuating mechanism is convenient to separate.

Description

Medical stitching instrument and actuating mechanism thereof

Technical Field

The invention relates to the field of medical instruments, in particular to a medical stitching instrument and an executing mechanism thereof.

Background

Medical staplers have been used in a wide variety of open or endoscopic procedures to effect the clamping or cutting of tissue.

The existing small-size suture device is mainly used for suturing blood vessels and stopping bleeding at bleeding points in the operation process, and because the human body has blood vessel sizes (thickness and width) with various specifications, the existing small-size suture device is used for suturing thicker blood vessels, has good hemostatic effect, but is used for suturing thinner blood vessels, and can cause the problems of blood leakage at the end face after cutting or blood leakage at the suturing position. This is because the existing stapler staples are uniform in size, resulting in a mismatch of the thickness of the vessel and staples and bleeding when stapling thin vessels.

To enhance the anastomosis effect, degradable membranes have been used in some stapler products. For example, patent CN213129668U discloses a reinforcement pad assembly for an anastomat, which comprises an anastomotic part made of degradable material and arranged on an anastomotic region of an anastomotic structure of the anastomat, a fixing part arranged on a non-anastomotic region of the anastomotic structure, and a suture line for suturing the junction of the anastomotic part and the fixing part, wherein the reinforcement pad assembly is connected to a nail bin and a nail anvil of an actuating mechanism, and after anastomosis is completed, the connection between the fixing part and the anastomotic part is released by pulling the suture line so as to bring the fixing part out of the body. However, the manner of securing the anastomosis and the fixation portion with the suture requires special handling of the suture, including positioning, pulling and removal of the suture, and great care must be taken during handling to avoid mishandling due to snagging and snagging of the suture. When the suture cannot be completely withdrawn, an additional step is required to shear the suture or anastomosis, resulting in a complicated surgical procedure.

Patent CN116473605a discloses a stapler assembly in which the front end of a cartridge biological patch is connected to a cartridge body or a staple blanket body by a fixing member, and the front end of the cartridge biological patch is cut by a cutter by forming a groove in the front end of the cartridge biological patch, thereby being separated from the cartridge body or the staple blanket body. However, the cutting knife will cause some damage to the cutting knife, reducing the quality of the tissue cut by the cutting knife, and a certain force is required to cut the forward end of the cartridge biological patch.

Disclosure of Invention

The invention aims to provide a novel medical stitching instrument and an actuating mechanism thereof.

In order to achieve the above purpose, the invention adopts the following technical scheme:

an actuator for a medical stapler includes a first clamping member;

a second clamping member capable of clamping tissue in cooperation with the first clamping member;

a staple pusher operable to move in a first direction;

the actuator further includes a locking assembly, a membrane assembly, and a flexible member, the first clamping member having a sliding region housing the locking assembly, the locking assembly including a locking slide slidably disposed within the sliding region;

the membrane assembly is mounted on the first clamping member, the membrane assembly comprises a membrane, a distal end connector and a proximal end connector, the membrane is located between the first clamping member and the second clamping member, two ends of the distal end connector are connected to the distal end portion of the membrane and enclose the first clamping member between the first clamping member and the membrane, the proximal end connector comprises a first proximal end branch and a second proximal end branch, one ends of the first proximal end branch and the second proximal end branch are connected to the proximal end portion of the membrane, and the other ends of the first proximal end branch and the second proximal end branch are connected through the locking sliding block and enclose the first clamping member between the first clamping member and the membrane;

two ends of the flexible component are respectively connected to the locking sliding block and the nail pushing piece;

when the staple pusher is moved in a distal direction, the staple pusher pulls on the flexible member and causes the locking slide to slide in a proximal direction to disconnect the first proximal branch from the second proximal branch.

According to the invention, through the design of the locking assembly, the membrane assembly and the flexible member, when the nail pushing piece is operated to move for stitching, the locking sliding block can be driven to slide and release the connection between the locking sliding block and the membrane assembly, so that the first proximal branch and the second proximal branch are disconnected, and after stitching is finished, the actuating mechanism can be pulled away to separate the actuating mechanism from the membrane assembly, so that the operation is very convenient.

Preferably, the locking slider has a locking portion extending toward a distal end direction, and first and second locking grooves adapted to the locking portion are respectively formed in the other ends of the first and second proximal branches, and the locking portion protrudes from the sliding region and is inserted into the first and second locking grooves.

In some embodiments, the locking portion is cylindrical.

In some embodiments, the first locking slot extends through the first proximal branch in a width direction of the first proximal branch, and the second locking slot extends through the second proximal branch in a width direction of the second proximal branch.

Preferably, the locking assembly further comprises an elastic member which is abutted between the locking slider and the sliding region so that the locking slider has a tendency to move in a direction approaching the other ends of the first proximal branch and the second proximal branch.

In some embodiments, the elastic member is a spring.

Preferably, the distal connector is integrally formed with the diaphragm.

Preferably, the first proximal branch and the second proximal branch are each integrally formed with the membrane.

Preferably, the membrane component is made of degradable polymer materials.

Further preferably, the degradable polymeric material includes, but is not limited to, polyglycolic acid (PGA), polypropylene, polylactic acid (PLA).

Preferably, the thickness of the membrane is 0.1 to 0.5mm, for example 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm.

Preferably, the front and/or rear end faces of the first clamping member have an inwardly recessed region, and the proximal connector is located within the recessed region to fix the relative position of the membrane assembly and the first clamping member.

Preferably, the sliding area is arranged on an end face facing away from the clamping face of the first clamping member, the first clamping member is further provided with a through groove, the through groove is located at the proximal end of the sliding area, and one end of the flexible member penetrates through the through groove to be connected to the locking sliding block or the nail pushing piece.

In some embodiments, the sliding region is a chute extending in a first direction.

Preferably, the nail pushing piece is provided with a limiting groove, the locking sliding block is provided with a hook groove protruding out of the outer surface of the locking sliding block, and two ends of the flexible component are connected with the nail pushing piece and the locking sliding block through the limiting groove and the hook groove respectively.

It is a second object of the present invention to provide a medical stapler including an actuator as described above.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

according to the invention, through the design of the membrane, the membrane and the tissues are stapled together during stapling, so that the thickness of the tissues can be increased, and the stapling effect is improved;

through locking element, flexible component, distal end connecting piece and proximal end connecting piece's design, when the operation push away the nail piece and remove in order to sew up, the locking slider can be released with the connection of proximal end connecting piece to make first proximal end branch and second proximal end branch disconnection, after the sewing up, take out the actuating mechanism and can realize the separation of actuating mechanism and membrane module, it is very convenient to operate.

Drawings

FIG. 1 is a schematic diagram of an embodiment of an actuator prior to stitching;

FIG. 2 is a schematic view of another angle structure of an actuator prior to stitching in accordance with an embodiment of the present invention;

FIG. 3 is an enlarged schematic view of portion A of FIG. 2;

FIG. 4 is a schematic diagram of a stitched structure of an actuator according to an embodiment of the present invention;

FIG. 5 is a schematic view of another angle structure of an actuator according to an embodiment of the present invention after stitching;

FIG. 6 is an enlarged schematic view of portion B of FIG. 5;

FIG. 7 is a schematic view of a membrane module according to an embodiment of the invention;

FIG. 8 is a schematic view of a locking slider according to an embodiment of the present invention;

wherein, 1, a first clamping member; 11. a chute; 12. a through groove; 13. a recessed region;

2. a second clamping member;

3. a nail pushing piece; 31. a limit groove;

4. a locking assembly; 41. a locking slide; 411. a locking part; 412. a hook groove; 42. an elastic member;

5. a membrane module; 51. a membrane; 52. a distal connector; 53. a first proximal branch; 531. a first locking groove; 54. a second proximal branch; 542. a second locking groove;

6. a flexible member; 61. a flexible member distal end; 62. a flexible member proximal portion;

x, first direction.

Detailed Description

The invention is further described below with reference to examples. The present invention is not limited to the following examples. The implementation conditions adopted in the embodiments can be further adjusted according to different requirements of specific use, and the implementation conditions which are not noted are conventional conditions in the industry. The technical features of the various embodiments of the present invention may be combined with each other as long as they do not collide with each other.

Hereinafter, only certain exemplary embodiments are briefly described. As will be recognized by those of skill in the pertinent art, the described embodiments may be modified in numerous different ways without departing from the spirit or scope of the embodiments of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

In describing embodiments of the present invention, it should be understood that the terms "distal," "proximal," and the like indicate a direction or positional relationship based on the direction or positional relationship that an operator observes when the medical stapler is in normal use and the operator holds the medical stapler, merely for convenience in describing embodiments of the present invention and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting embodiments of the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the embodiments of the present invention, the meaning of "plurality" is two or more, unless explicitly defined otherwise.

The following disclosure provides many different implementations, or examples, for implementing different configurations of embodiments of the invention. In order to simplify the disclosure of embodiments of the present invention, components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present invention. Furthermore, embodiments of the present invention may repeat reference numerals and/or letters in the various examples, which are for the purpose of brevity and clarity, and which do not themselves indicate the relationship between the various embodiments and/or arrangements discussed.

Example 1

In this example, the medical stapler of the present invention is specifically explained using a small-sized stapler as an example, but it should be noted that the actuator mechanism according to the embodiment described below may be replaced with other types of staplers.

The medical stapler comprises an instrument platform (not shown in the drawing of the invention), a handle (not shown in the drawing of the invention) movably connected to the instrument platform, and an actuator detachably connected to the distal end of the instrument platform. The instrument platform and the handle can adopt structures commonly used in the prior art, and are not described in detail in the invention.

The actuator comprises a pair of clamping members, namely a first clamping member 1 and a second clamping member 2, having a clamping state (see fig. 1) capable of closing relative to each other to sandwich tissue to be stapled, and an open state (not shown in the figures) capable of opening relative to each other, and a staple pusher 3. Specifically, the actuator further comprises a housing (not shown in the figures), and the first clamping member 1 is fixedly mounted at the distal end of the housing, which comprises an anvil; the second clamping member 2 is rotatably arranged at the distal end of the housing and comprises a staple cartridge arranged opposite to the anvil, and staples and a firing block are arranged in the staple cartridge. The housing, staple blanket, and cartridge assembly may be constructed as described in the prior art and are not described in detail herein.

The staple pusher 3 is disposed within and axially movable along the housing, the staple pusher 3 being operatively connected to an actuation source, such as a handle of a medical stapler, and when the staple pusher 3 is operated to move in a distal direction (i.e., the first direction x), the staple pusher 3 can push a firing block within the staple cartridge distally to sequentially push staples out of the staple cartridge and into engagement with tissue in the anvil.

In order to enhance the anastomosis effect of the suturing device on the thin blood vessel and reduce post-suturing bleeding and end surface bleeding of the thin blood vessel, the membrane assembly 5, the locking assembly 4 and the flexible member 6 are arranged on the actuating mechanism, and the membrane assembly 5 and the actuating mechanism can be reliably connected through the structural design of the membrane assembly 5, the locking assembly 4 and the flexible member 6, so that the membrane assembly 5 cannot fall off from the actuating mechanism in advance during normal use of the suturing device in vivo (before suturing) after the puncture device passes through the actuating mechanism, and the membrane assembly 5 can be smoothly separated from the actuating mechanism after the suturing is finished. The locking assembly 4, the membrane assembly 5 and the flexible member 6 are discussed in detail below.

Referring to fig. 1-8, the actuator includes a locking assembly 4, a membrane assembly 5, and a flexible member 6. In this embodiment, the locking assembly 4 and the membrane assembly 5 are disposed on the first clamping member 1, and in other embodiments, the locking assembly 4 and the membrane assembly 5 may be disposed on the second clamping member 2, or a group of locking assemblies 4 and membrane assemblies 5 may be disposed on the first clamping member 1 and the second clamping member 2 at the same time.

Referring to fig. 7, the membrane assembly 5 includes a membrane 51, a distal connector 52, and a proximal connector.

The membrane 51 is located between the first clamping member 1 and the second clamping member 2, the membrane 51 preferably being adapted to the clamping surface of the first clamping member 1, the membrane 51 preferably having a thickness of 0.1-0.5 mm.

The distal connector 52 is substantially strip-shaped, and has two ends connected to the distal end of the diaphragm 51 and encloses the first clamping member 1 between the first clamping member and the diaphragm 51 (as shown in fig. 1, 2, 4 and 5), and the distal connector 52 is attached to the first clamping member 1. Preferably, distal connector 52 is integrally formed with diaphragm 51.

The proximal connector comprises a first proximal branch 53 and a second proximal branch 54, the first proximal branch 53 and the second proximal branch 54 are substantially strip-shaped, one end of the first proximal branch 53 and one end of the second proximal branch 54 are connected to the proximal end of the membrane 51, the other end is free and connected by the locking assembly 4 and encloses the first clamping member 1 between the first clamping member and the membrane 51 (as shown in fig. 1, 2, 4 and 5), and the first proximal branch 53 and the second proximal branch 54 are attached to the first clamping member 1. Preferably, the first proximal branch 53 and the second proximal branch 54 are respectively formed integrally with the membrane 51.

Further, the other end of the first proximal branch 53 is provided with a first locking groove 531, the first locking groove 531 penetrates the first proximal branch 53 along the width direction of the first proximal branch 53, the other end of the second proximal branch 54 is provided with a second locking groove 542, and the second locking groove 542 penetrates the second proximal branch 54 along the width direction of the second proximal branch 54. The locking assembly 4 comprises a locking slider 41, the locking slider 41 having a locking portion 411 extending in the distal direction and adapted to the first locking groove 531 and the second locking groove 542, the locking portion 411 being inserted in the first locking groove 531 and the second locking groove 542 to connect the first proximal branch 53 and the second proximal branch 54 (as shown in fig. 3). Preferably, the locking portion 411 has a cylindrical shape. Two ends of the flexible component 6 are respectively connected with the locking slide block 41 and the nail pushing piece 3; when the staple pusher 3 is moved in the distal direction, the staple pusher 3 pulls the flexible member 6 and drives the locking slide 41 to slide in the proximal direction to disengage the locking portion 411 from the first and second locking slots 531, 542, and the first and second proximal branches 53, 54 are disconnected (as shown in fig. 6).

The first clamping member 1 has a sliding region accommodating the locking assembly 4, the locking slider 41 is slidably disposed in the sliding region, the locking slider 41 has a hook groove 412 protruding from an outer surface of the locking slider 41, and the hook groove 412 is exposed to the sliding region. The sliding region is specifically formed on an end surface facing away from the clamping surface of the first clamping member 1, and preferably the sliding region is a chute 11 extending in the first direction x.

The locking assembly 4 further comprises an elastic member 42, the elastic member 42 being arranged against the locking slider 41 and the sliding region such that the locking slider 41 has a tendency to move in a direction approaching the other ends of the first proximal branch 53 and the second proximal branch 54, thereby maintaining the locking slider 41 in connection with the first proximal branch 53 and the second proximal branch 54. Preferably, the elastic member 42 is a spring, which is provided at the proximal end of the lock slider 41.

The flexible member 6 is generally not elastic, and may be a string, and the distal end portion 61 of the flexible member may be connected to the hooking groove 412 by knotting, or may be connected to the locking slider 41 by hooking the hooking groove 412 by providing a hook at the end portion. The first clamping member 1 is further provided with a through groove 12, the through groove 12 is located at the proximal end of the sliding region, the proximal end 62 of the flexible member passes through the through groove 12 and is connected to the staple pushing piece 3, the staple pushing piece 3 is provided with a limiting groove 31, the proximal end 62 of the flexible member is connected to the limiting groove 31, and the connection mode refers to the connection mode of the distal end 61 of the flexible member and the hook groove 412, which is not repeated here. When the staple pusher 3 is moved distally, the flexible member 6 tightens and pulls the locking slide 41 to slide in the proximal direction within the chute 11.

To further increase the stability of the connection of the membrane assembly 5 to the first clamping member 1, the front and/or rear end face of the first clamping member 1 has an inwardly recessed area 13, and the proximal connector is located in the recessed area 13 to fix the relative position of the membrane assembly 5 and the first clamping member 1.

To facilitate the mounting of the membrane assembly 5, the width and height of the distal portion of the first clamping member 1 gradually decreases from its proximal end towards its distal end.

The membrane module 5 is made of a degradable polymer material, such as polyglycolic acid (PGA), polypropylene or polylactic acid (PLA).

The working process comprises the following steps:

in the mounting process, the distal connector 52 is sleeved on the first clamping member 1, the membrane 51 is attached to the clamping surface of the first clamping member 1, and the locking part 411 is inserted into the first locking groove 531 and the second locking groove 542, so that the mounting of the membrane module 5 is completed.

When the suturing is completed, the staple pushing element 3 is operated to move towards the distal end direction, the staple pushing element 3 pulls the flexible member 6, the locking sliding block 41 is driven to compress the elastic element 42 and move towards the opposite direction, the locking part 411 is withdrawn from the first locking groove 531 and the second locking groove 542, the first proximal branch 53 and the second proximal branch 54 are disconnected, and when the suturing is completed, the actuating mechanism is pulled out towards the proximal end direction along the distal end of the actuating mechanism, so that the separation of the membrane assembly 5 and the first clamping member 1 can be realized.

The actuating mechanism has at least the following advantages:

(1) The membrane module 5 is convenient to separate, when the staple pushing piece 3 is operated to move for stitching, the locking sliding block 41 can be disconnected with the proximal connecting piece, so that the first proximal branch 53 and the second proximal branch 54 are disconnected, and when stitching is finished, the actuating mechanism is pulled away, so that the actuating mechanism and the membrane module 5 can be separated, and the operation is convenient.

(2) The membrane module 5 is firmly connected with the first clamping member 1, the membrane module 5 cannot fall off from the first clamping member 1 in advance before sewing, and the membrane module 5 can be smoothly separated after sewing is finished.

(3) Compared with the membrane component 5 in the suture fixing mode in the prior art, the membrane component 5 in the invention has simpler structure and more convenient and convenient installation and detachment; compared with the prior art that the membrane module 5 needs to be cut off to be separated, the membrane module 5 is separated without using a cutting knife, so that the cutting knife is not damaged.

(4) The execution mechanism of the invention can improve the suturing effect and is suitable for suturing blood vessels with different thicknesses.

The present invention has been described in detail with the purpose of enabling those skilled in the art to understand the contents of the present invention and to implement the same, but not to limit the scope of the present invention, and all equivalent changes or modifications made according to the spirit of the present invention should be included in the scope of the present invention.

Claims

1. An actuator for a medical stapler includes a first clamping member;

a staple pusher operable to move in a first direction;

the method is characterized in that: the actuator further includes a locking assembly, a membrane assembly, and a flexible member, the first clamping member having a sliding region housing the locking assembly, the locking assembly including a locking slide slidably disposed within the sliding region;

when the staple pusher is moved in a distal direction, the pusher pulls the flexible member and moves the locking slide in a proximal direction to disconnect the first proximal branch and the second proximal branch.

2. The actuator of claim 1, wherein: the locking slider is provided with a locking part extending towards the distal end direction, a first locking groove and a second locking groove which are matched with the locking part are respectively formed in the other ends of the first proximal branch and the second proximal branch, and the locking part protrudes out of the sliding area and is inserted into the first locking groove and the second locking groove.

3. The actuator of claim 2, wherein: the locking part is cylindrical; and/or the number of the groups of groups,

the first locking groove penetrates through the first proximal branch along the width direction of the first proximal branch, and the second locking groove penetrates through the second proximal branch along the width direction of the second proximal branch.

4. The actuator of claim 1, wherein: the locking assembly further includes an elastic member disposed against the locking slider and the sliding region such that the locking slider has a tendency to move in a direction approaching the other ends of the first proximal branch and the second proximal branch.

5. The actuator of claim 1, wherein: the distal end connecting piece and the diaphragm are integrally formed; and/or the number of the groups of groups,

the first proximal branch and the second proximal branch are respectively integrally formed with the diaphragm; and/or the number of the groups of groups,

the membrane component is made of degradable high polymer materials; and/or the number of the groups of groups,

the thickness of the membrane is 0.1-0.5 mm.

6. The actuator of claim 1, wherein: the front end face and/or the rear end face of the first clamping member has an inwardly recessed region, and the proximal connector is located within the recessed region to fix the relative position of the membrane assembly and the first clamping member.

7. The actuator of claim 1, wherein: the sliding area is arranged on the end face deviating from the clamping face of the first clamping component, the first clamping component is further provided with a through groove, the through groove is positioned at the proximal end of the sliding area, and one end of the flexible component penetrates through the through groove to be connected to the locking sliding block or the nail pushing piece.

8. The actuator of claim 1 or 7, wherein: the sliding region is a sliding groove extending along a first direction.

9. The actuator of claim 1, wherein: the nail pushing piece is provided with a limiting groove, the locking sliding block is provided with a hook groove protruding out of the outer surface of the locking sliding block, and two ends of the flexible component are connected with the nail pushing piece and the locking sliding block through the limiting groove and the hook groove respectively.

10. A medical stapler, characterized in that: the medical stapler comprises the actuator of any one of claims 1 to 9.