WO2022237372A1 - 微创手术缝合线端部锁结装置、方法及操作枪体 - Google Patents

微创手术缝合线端部锁结装置、方法及操作枪体 Download PDF

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Publication number
WO2022237372A1
WO2022237372A1 PCT/CN2022/084310 CN2022084310W WO2022237372A1 WO 2022237372 A1 WO2022237372 A1 WO 2022237372A1 CN 2022084310 W CN2022084310 W CN 2022084310W WO 2022237372 A1 WO2022237372 A1 WO 2022237372A1
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WO
WIPO (PCT)
Prior art keywords
suture
locking
minimally invasive
clamping structure
power rod
Prior art date
Application number
PCT/CN2022/084310
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English (en)
French (fr)
Inventor
郭燕林
张伟
Original Assignee
江苏泰科博曼医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 江苏泰科博曼医疗器械有限公司 filed Critical 江苏泰科博曼医疗器械有限公司
Priority to EP22806342.6A priority Critical patent/EP4166097A1/en
Priority to JP2022565881A priority patent/JP7336123B2/ja
Priority to US17/900,837 priority patent/US20230225727A1/en
Publication of WO2022237372A1 publication Critical patent/WO2022237372A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0467—Instruments for cutting sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0474—Knot pushers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures

Definitions

  • the invention relates to the technical field of medical devices, in particular to a minimally invasive surgery suture end locking device, method and operating gun body.
  • a locking device that can lock the end of the suture through the locking nail.
  • the elastic deformation of the locking nail is used to clamp the end of the suture.
  • the final locking nail is attached to the surface of human tissue to prevent the loosening of the suture.
  • the invention provides a minimally invasive surgical suture end locking device, which can effectively solve the problems in the background technology; at the same time, the invention also claims a minimally invasive surgical suture end locking method, a micro The locking operation gun body at the end of surgical suture thread has the same technical effect.
  • Suture end locking device for minimally invasive surgery, used for clamping and fixing the end of suture through locking nails, including: thread hook assembly, clamping structure, power rod and outer catheter;
  • the wire hook assembly includes an annular structure surrounded by a flexible material, and a force application end drawn out relative to the annular structure; the annular structure is drawn out from the through area of the locking nail, and the drawn part forms a closed area; the The force-applying end is used for partially penetrating the suture thread that enters the closed area by pulling the annular structure under the action of external force in the human body;
  • the clamping structure is used to squeeze the locking nail, so that the locking nail is deformed to clamp the suture;
  • the power rod is provided with a pressing part, and the clamping structure is tightened by linear motion. extruding to move the clamping structure to complete the extruding action;
  • Both the clamping structure and the power rod are installed in the outer catheter, the locking nail is inserted from the end of the outer catheter, and the stopper structure arranged on the locking nail limits the depth of insertion; the outer
  • the catheter is provided with a through hole, the through hole is set on the side of the contact position of the clamping structure and the power rod, and within a set distance from the contact position, a part of the suture thread passing through the through area can be looped Pulling out of the structure.
  • the through hole is a straight hole and extends along the linear movement direction of the power rod.
  • the force applying end is a hook structure.
  • the end of the power rod also includes a cutting part
  • the cutting part is close to one side wall of the through hole along with the extrusion movement of the power rod, until it reaches a sufficiently close distance with respect to one side wall of the through hole and continues to approach, the cutting part
  • the cutting part realizes the cutting of the suture thread passing through the through hole by cooperating with the edge of the side wall on one side.
  • the outer catheter also includes a guide seat installed at the end;
  • the guide seat is used to limit the insertion depth of the locking nail, and provide guidance for the movement of the clamping structure.
  • the movement of the clamping structure is perpendicular to the direction in which the locking nail is inserted into the guide seat.
  • the guide seat is provided with a guide groove
  • the clamping structure is provided with a protruding part, and the protruding part moves along the guide groove.
  • clamping structure is provided with at least one protruding structure facing the locking nail, and the protruding structure partially presses the locking nail.
  • the extruding portion includes a slope for pressing the clamping structure, the end of the slope forms a sharp structure that can be inserted into the gap between the clamping structure and the inner wall of the outer conduit, and the slope
  • the guiding direction of the clamping structure is set obliquely relative to the guiding seat.
  • the minimally invasive surgical suture end locking method adopts the aforementioned minimally invasive surgical suture end locking device, comprising the following steps:
  • controlling the end of the suture is: pulling the end of the suture on the side of the locking nail close to the sutured tissue, so that during the process of pulling the force-applying end, the suture deviates from the end The positions overlap and run through the penetrating area of the locking nail.
  • controlling the end of the suture is: pulling the force-applying end, driving the end of the suture through the ring-shaped structure through the penetrating area of the locking nail, and pulling on the side of the locking nail away from the suture tissue. Pull the suture ends.
  • the minimally invasive surgery suture end locking operating gun body including the minimally invasive surgical suture end locking device as described above, also includes an operating component, which is located outside the human body for operation;
  • the operating assembly includes two half shells that are butted and assembled to form a cavity, and a force applying handle partially installed in the cavity, and the force applying handle is rotatably connected to the half shells;
  • One end of the force application handle located in the cavity is slidably connected to the power rod, the outer section of the outer conduit is cylindrical, and the axis of the cylinder is fixed relative to the half shell; the force application The force handle squeezes the power rod during rotation.
  • the end of the power rod is provided with a connecting structure slidingly connected with the force application handle, and the connecting structure includes:
  • the end of the force application handle is provided with a groove for accommodating the connecting rod, and the end of the force application handle is attached to the first stopper and the second stopper respectively.
  • the first stopper is in contact with the force-applying handle through a spherical surface, and the force-applying handle is correspondingly provided with a curved surface bent in the same direction to fit the spherical surface.
  • the force applying handle is in contact with the second stopper through a curved surface.
  • the rotating structure also includes a rotating structure, the first end of the rotating structure is sheathed outside the outer catheter, and is located outside the cavity, and is fixedly connected with the outer catheter; the second end of the rotating structure The end is sleeved on the outside of the power rod, and located inside the cavity, and drives the power rod to rotate.
  • a card slot is provided between the first end and the second end, and the card slot accommodates a partial edge of the half shell.
  • the second end is attached to the power rod through the prismatic through hole to realize the transmission of rotational power.
  • the induction structure includes a rod drawn out from the force applying handle, and a stepped seat provided on the inner wall of the cavity and having several stepped structures;
  • the rod body is in contact with the stepped seat, and during the rotation of the force applying handle, it successively reaches different step structures on the stepped seat to generate a stuck feeling, and the stuck feeling is directed to the operation through the force applying handle. passed on.
  • the present invention provides a device that can directly tighten and lock the suture at the proximal end of the position where the suture is led out from the human body tissue. It is easier to control the suture tightness of the suture to the tissue, avoiding the control difficulty caused by the excessive length of the suture thread and its own elasticity.
  • the present invention also claims a minimally invasive surgical suture end locking method and an operating gun body, and the same technical effect can be obtained by applying the above-mentioned device.
  • Fig. 1 is the schematic structural view of the catheter except the locking device at the end of the minimally invasive surgery suture;
  • Fig. 2 is the structural representation of locking nail
  • Fig. 3 is a schematic diagram of the insertion of the ring structure of the thread hook assembly into the through area of the locking nail;
  • Fig. 4 is a schematic diagram after the insertion process in Fig. 3 is completed;
  • Figure 5 is a schematic diagram of the installation of the support buckle
  • Fig. 6 is a schematic diagram of the wire hook assembly and the locking nail after being installed relative to the outer catheter;
  • Fig. 7 is a schematic diagram of the process of cutting the suture by the cutting part
  • Fig. 8 is a cross-sectional view of the end of the power rod
  • Fig. 9 is a schematic diagram of the installation of the guide seat relative to the wire hook assembly and the clamping structure
  • Fig. 10 is a structural schematic diagram of the clamping structure
  • Figure 11 is a schematic diagram of the installation of the guide seat relative to the wire hook assembly
  • Figure 12 is a schematic diagram of the position of the two clamping structures relative to the locking nail
  • Fig. 13 is a cross-sectional view of the installation position of the clamping structure optimization mode
  • Figure 14 is a schematic diagram of the installation of the clamping structure optimization mode
  • FIG. 15 are schematic diagrams of four kinds of concentrated stress positions of locking nails
  • Fig. 16 is an installation schematic diagram of another clamping structure
  • Fig. 17 is a flow chart of the method for locking the ends of sutures in minimally invasive surgery
  • Figure 18 is a schematic diagram of the end of the suture entering the closed area
  • Fig. 19 is a schematic diagram of the overlapped positions of the sutures deviated from the ends and passing through the penetrating area of the locking nail;
  • Fig. 20 is a schematic diagram of the penetrating region where the end of the suture thread passes through the locking nail;
  • Fig. 21 is a schematic structural view of the operation gun body for locking the end of the minimally invasive surgical suture (only one half shell is shown);
  • Figure 22 is a partial enlarged view of the connection position between the half shell and the force application handle
  • Fig. 23 is a partial enlarged view of place A in Fig. 22;
  • Figure 24 is a schematic diagram of the position and structure of the connecting structure
  • Fig. 25 is a partial enlarged view of the connection position between the connection structure and the force application handle
  • Fig. 26 is a partial enlarged view of place B in Fig. 25;
  • Figure 27 is a schematic view of the position and structure of the rotating structure
  • Figure 28 is a schematic structural view of the half shell
  • Figure 29 is a partial enlarged view at C in Figure 28;
  • Figure 30 is a partial enlarged view at D in Figure 25;
  • the minimally invasive surgical suture end locking device is used to clamp and fix the end of the suture 50 through the locking nail 40, including: hooking thread assembly 10, clamping structure 20, power rod 30 and the outer catheter 60;
  • the hook wire assembly 10 includes an annular structure 101 surrounded by a flexible material, and a force application end 102 drawn out relative to the annular structure 101;
  • the annular structure 101 is drawn out from the through region 401 of the locking nail 40, and the drawn part forms Closed area;
  • the force application end 102 is used to drive the suture 50 into the closed area by pulling the ring structure 101 under the external force of the human body to partially penetrate through the through area 401;
  • the clamping structure 20 is used to squeeze the locking nail 40, so that The locking nail 40 is deformed to clamp the suture 50;
  • the power rod 30 is provided with an extruding part 301, which squeezes the clamping structure 20 through linear motion, so that the clamping structure 20 moves to complete the extrusion action;
  • the present invention provides a device that can directly tighten and lock the suture thread 50 at the proximal end of the position where it is led out from the human body tissue. In other words, it is easier to control the tightness of the suture 50 to the tissue, avoiding the control difficulty caused by the too long thread of the suture 50 and its own elasticity.
  • connection between the annular structure 101 and the force application end 102 is preferably completed in advance, so as to participate in the subsequent operation as an integral consumable; the connection of the locking nail 40 with respect to the outer catheter 60 is preferably performed after the connection with the wire hooking assembly 10 is completed.
  • the connection between the wire hook assembly 10 and the locking nail 40 is shown in FIGS. 3 and 4 .
  • the annular structure 101 can be inserted into the penetrating area 401 of the locking nail 40 .
  • the support buckle 103 can be set to support the ring structure 101 drawn from the locking nail 40.
  • the support is preferably to make the ring structure 101 obtain a certain elastic expansion, so as to ensure a tight fit with the support buckle 103
  • structures such as grooves can also be provided on the support buckle 103 to accommodate the ring structure 101, and the support buckle 103 can be removed before use.
  • the through hole 601 is a straight hole and extends along the linear movement direction of the power rod 30, so that the position determination process of the wire hook assembly 10 relative to the outer catheter 60 It is more convenient to realize, especially for the process of the force application end 102 passing through the through hole 601, a larger space is obtained.
  • the force application end 102 As the structural form of the force application end 102, it is a priority to be easy to operate in the body. Based on the above purpose, as a preferred embodiment, see Figure 1 and Figure 6, the force application end 102 is a hook structure, which can make the present It is more convenient to apply force to it with instruments, and it is easy to process.
  • the structural form of the power rod 30 is optimized.
  • the end of the power rod 30 also includes a cutting part 302; One side wall, until the side wall relative to the through hole 601 reaches a sufficiently close distance and continues to approach, the cutting part 302 realizes passing through the suture 50 in the through hole 601 by cooperating with the edge of one side wall cutting.
  • the cutting part 302 can be formed directly during the processing of the power rod 30, and the extrusion part 301 can also be obtained in the same way, so that the power rod 30 as an integral structure can be formed in the process of power supply and cutting. It ensures better stability and is more durable, which also reduces the difficulty of product installation.
  • FIG. 7 it shows that the cutting part 302 performs the cutting action, which is carried out synchronously with the extrusion process of the power rod 30 on the clamping structure 20, and the independent cutting step for the suture 50 can be completely omitted.
  • the cutting portion 302 Before cutting, it is necessary to ensure that the suture 50 is pulled in place, and as the cutting portion 302 approaches one side wall of the through hole 601, the cutting portion 302 and one side wall of the through hole 601 form an approximately double-edged structure.
  • the purpose of cutting is easier to achieve.
  • the shape of the cutting part 302 can be optimized, so as to control the sharpness of the cutting edge provided by it.
  • the power rod 30 is installed inside the outer catheter 60 and will not cause any impact on the patient. Compared with the improvement of the side wall of the through hole 601, there is more room for improvement. Referring to FIG. 8 , it is located at the end of the power rod 30 , and its shape can be controlled through subsequent processing.
  • the outer catheter 60 also includes a guide seat 602 installed at the end; the guide seat 602 is used to limit the insertion depth of the locking nail 40, and to clamp Movement of structure 20 provides guidance.
  • the guide seat 602 is separated from the outer conduit 60, the clamping structure 20 can be installed. After the installation is completed, it can be directly installed as a whole.
  • the guiding function here can realize the relative fixation of the clamping structure 20 in a narrow space. And accurately limit its movement direction.
  • the smaller external size of the outer catheter 60 is more optimal for the patient.
  • the clamping structure 20 achieves locking through a smaller range of motion. A greater compression degree of the nail 40 is more desirable.
  • the movement of the clamping structure 20 is perpendicular to the direction in which the locking nail 40 is inserted into the guide seat 602 .
  • the guiding seat 602 is provided with a guiding groove 6021
  • the clamping structure 20 is provided with a protruding portion 201
  • the protruding portion 201 moves along the guiding groove 6021 .
  • the comprehensive selection of the installation space in the outer conduit 60, the shape of the power rod 30, etc. as shown in Figure 12, it shows the way of setting two clamping structures 20, correspondingly, It is sufficient to arrange two extruding parts 301 at the end of the power rod 30 .
  • the clamping structure 20 is set in the form of a V-shaped clamp, as shown in Figures 13 and 14, the V-shaped clamp here specifically includes a first set of angles.
  • a clamping structure 204 and a second clamping structure 205 and when the first clamping structure 204 is fixedly arranged, the second clamping structure 205 can be elastically deformed by itself under the extrusion of the power rod 30, or by relative The elastic change of the angle of the first clamping structure 204 , or the above two situations occur simultaneously, thereby approaching the first clamping structure 204 , and when the pressing force is released, elastic reset can be realized.
  • the purpose of being squeezed and deformed can be achieved only by setting the position where the locking nail 40 needs to be clamped between the two.
  • extending the length of the first clamping structure 204 and the second clamping structure 205 as much as possible can make the above-mentioned elastic change relatively easy, and in order to achieve this purpose, a The recessed area partially accommodates the clamping structure 20 to accommodate the extension of its length.
  • the clamping structure 20 is integrally formed with the plug 603 used to seal the end of the outer conduit 60, so that the difficulty of installation can be further reduced.
  • the plug 603 is connected to the first clamping structure 204; in order to obtain better strength for the first clamping structure 204, it can be set as a stepped structure, so that while the strength is improved, it can also pass through the stepped surface Realizing the further positioning of the locking nail 40, or other special-shaped forms that meet the space requirements are also within the protection scope of the present invention. Since the clamping structure 20 of this structural form occupies a relatively large position in the outer catheter 60, it will affect the drawing of the suture from the through hole 601 to a large extent.
  • the first clamping structure can The hole position 204a corresponding to the through hole 601 is set on the 204, so as to avoid the occurrence of interference.
  • the clamping structure 20 is provided with There is at least one protruding structure 202 facing the locking nail 40 , and the protruding structure 202 partially compresses the locking nail 40 .
  • the pressing form of the protrusion structure 202 on the locking nail 40 can form a more concentrated extrusion position for the suture 50, as compared to the overall flat pressing of the locking nail 40, as indicated by the arrow in Figure 15, that is, the suture
  • the line 50 acquires the location of the concentrated extrusion.
  • What is shown in figure (a) is the force-bearing position of the locking nail 40 that ensures that the suture 50 is stably fixed through a centralized extrusion.
  • other positions of the locking nail 40 can be used except for the concentrated extrusion position.
  • Deformation is generated by means of flat pressing, thereby obtaining a slightly smaller extrusion force relative to the concentrated extrusion position; (b) in the figure shows that the protrusion structure 202 on the clamping structure 20 is more than one, specifically two , the concentrated stress position of the locking nail 40 has the same effect as that at (a) in the figure.
  • the fixing effect for the suture 50 is better, but it will appropriately increase the processing difficulty of the clamping structure 20; in (c) in the figure It shows that there are two clamping structures 20, and each clamping structure 20 is provided with a protruding structure 202 to squeeze the locking nail 40, the concentrated stress position of the locking nail 40; the figure (d) shows If there are two clamping structures 20, and each clamping structure 20 has more than one protruding structure 202, specifically two, the concentrated stress position of the locking nail 40 is preferably as shown in the figure in this way As shown, the protruding structures 202 on the two clamping structures 20 are misplaced, so that the squeezed locking nail 40 can obtain a final shape similar to waves, and the fixing effect on the suture 50 is better; in each of the above solutions , can be selected according to actual needs.
  • a corresponding recessed area can also be provided, and the area squeezed and deformed by the protruding structure 202 can be deformed into the recessed area, as shown in Figure 13, which shows the setting of the recessed area
  • the recessed area can be a part of the clamping structure 20 or a part of the outer catheter 60 .
  • the extruding portion 301 includes a slope 3011 that squeezes the clamping structure 20 , and the end of the slope 3011 forms a sharp edge that can be inserted into the gap between the clamping structure 20 and the inner wall of the outer conduit 60 .
  • the slope surface 3011 is set obliquely to the guide direction of the clamping structure 20 relative to the guide seat 602; through the setting of the slope surface 3011, the linear motion of the power rod 30 is converted into the linear motion of the clamping structure 20, and the direction change is realized .
  • a guide surface 203 corresponding to the slope surface 3011 can be provided, or, as shown in Figure 16, the clamping
  • the structure 20 is configured as a shaft structure, or a structure with a partially curved surface, so that the curved surface and the slope surface 3011 are pressed against each other.
  • the minimally invasive surgical suture end locking device As the locking method of the above-mentioned minimally invasive surgical suture end locking device, the following steps can be specifically referred to, so as to achieve a better use effect, as shown in Figure 17, the minimally invasive surgical suture end locking method, Using the minimally invasive surgical suture end locking device as described above includes the following steps:
  • S3 pull the force application end 102, and control the end of the suture 50 so that the suture 50 partially penetrates the through area 401 and maintain a set tension range; wherein, the purpose of pulling the force application end 102 is to drive the suture 50 to enter and pass through The penetrating area 401 of the locking nail 40 is squeezed and fixed, and the control of the end of the suture 50 is aimed at avoiding loosening during the operation and affecting the effect of tissue suturing;
  • S5 Provide extrusion power for the clamping structure 20 through the power rod 30, and complete the clamping of the suture 50 by the locking nail 40; in this process, the operator needs to apply force to the power rod 30 outside the human body;
  • control for the suture 50 end can include two ways:
  • Method 1 As shown in FIG. 19 , controlling the end of the suture 50 is as follows: pull the end of the suture 50 on the side of the locking nail 40 close to the sutured tissue, so that the suture 50 deviates from the end during the process of pulling the force applying end 102 The positions overlap and pass through the penetrating region 401 of the locking nail 40 .
  • the end 501 of the suture 50 and the self-tissue leading end 502 of the suture 50 are located on one side of the locking nail 40, wherein the end 501 is controlled by the instrument, and the self-tissue leading end 502 is restricted by the tissue.
  • the suture thread 50 pulls the suture thread 50, which will cause the suture thread 50 to form a part that overlaps and doubles the number of threads, and this part will be finally squeezed and fixed in the through area 401 of the locking nail 40; in this way, due to The number of sutures 50 inside the locking nail 40 increases, which can make the extrusion more stable, and the end 501 is fixed by the instrument during the whole process, effectively avoiding the problem of sutures 50 loosening, but this method In this case, the size of the penetrating area 401 of the locking nail 40 may be relatively large.
  • Method 2 As shown in FIG. 20 , the end of the suture 50 is controlled as follows: pulling the force-applying end 102, and the end 501 of the suture 50 is driven through the ring structure 101 to penetrate the penetration area 401 of the locking nail 40, and when the locking nail 40 is away from the suture tissue, The end of the suture 50 is pulled on one side.
  • the end 501 refers to the most marginal part of the ends of the suture 50 within a certain length; the end 501 of the suture 50 completely passes through the penetrating region 401. Pull the sutures 50. In this process, the number of sutures 50 passing through the locking nails 40 is small, so the size of the locking nails 40 can be reduced. However, when the end 501 passes through the penetrating region 401, the sutures 50 may be Some loosening occurs, but can be re-tightened later by pulling on the ends
  • the locking device at the end of minimally invasive surgical sutures in the present invention can work by being installed on the operating gun body, specifically as in the following embodiments:
  • the minimally invasive surgery suture end locking operating gun body includes the minimally invasive surgical suture end locking device described above, and also includes an operating component 70 located outside the human body for operation.
  • the operating assembly 70 includes two half shells 701 that are butted and assembled to form a cavity, and a force applying handle 702 partially installed in the cavity, and the force applying handle 702 is rotationally connected with the half shell 701; the force applying handle 702 is located at one end of the cavity Slidingly connected with the power rod 30 , the outer section of the outer conduit 60 is cylindrical, and the axis of the cylinder is fixed relative to the half shell 701 ; the force applying handle 702 squeezes the power rod 30 during rotation.
  • the two half-shells 701 are docked through the existing fixing method, and the docking here can be set to be detachable, so as to facilitate the observation of the internal structure, etc.
  • the force application handle 702 is provided with a shaft body, and the half shell 701 is provided with a hole for the shaft body to be inserted, so that the force application handle 702 can be naturally fixed during the docking and assembling process of the two half shells 701 .
  • the force applying handle 702 may adopt an integral structure, or may be a separate assembly structure, which can be selected according to actual production needs.
  • connection structure 303 includes:
  • the first stopper 3031 and the second stopper 3032 arranged side by side along the length direction of the power rod 30 are connected by a connecting rod 3033 between the first stopper 3031 and the second stopper 3032, wherein the connecting rod 3033 and the power
  • the rods 30 are parallel; the end of the force application handle 702 is provided with a groove 7021 for accommodating the connecting rod 3033, and the end of the force application handle 702 fits with the first stopper 3031 and the second stopper 3032 respectively, wherein the first A block 3031 is relatively close to the end locking device of the minimally invasive surgical suture.
  • the force applying handle 702 is rotated reversely after pressing the connecting structure 303, so that the power rod 30 can be driven to reset during the process of releasing the squeezing structure 20 from the clamping structure 20, so that The clamping structure 20 in contact with the locking nail 40 is no longer subjected to the extrusion force, which facilitates the removal of the locking nail 40 relative to the outer catheter 60 .
  • the first stopper 3031 is in contact with the force application handle 702 through a spherical surface, and the force application handle 702 is correspondingly provided with a curved surface bent in the same direction to fit the spherical surface; the spherical surface and the curved surface During the sliding process of the force application handle 702 relative to the first stopper 3031, the fitting can make the sliding smoother and reduce the frictional surface damage caused by hard friction.
  • the spherical surface can be one of spherical or ellipsoidal, but is preferably regular, so as to facilitate processing.
  • the curved surface on the force application handle 702 can be adapted to the curved form of the spherical surface, and can be formed synchronously with the force application handle 702 or obtained by subsequent processing.
  • the force application handle 702 is in contact with the second stop 3032 through a curved surface; and there is no additional processing requirement for the second stop 3032, because during the return process of the force application handle 702, the contact with the second stop
  • the extrusion force between the blocks 3032 is relatively small, so the curved surface of the force-applying handle 702 can fully meet the purpose of smooth sliding between the two, thereby reducing the processing difficulty of the second block 3032; specifically, the second block can be
  • the block 3032 is set as a circular piece, and a blocking structure is set inside the cavity, which can limit the limit position of its return stroke.
  • the combined structure of the first block 3031, the second block 3032 and the connecting rod 3033 can be integrally formed, and after the independent processing is completed, it is connected with the main body of the power rod 30 to obtain the complete structure of the power rod 30.
  • the method is relatively simple, and the shape is easier to control.
  • the minimally invasive surgery suture end locking operation gun body also includes a rotating structure 80, the first end 801 of the rotating structure 80 is sleeved outside the outer catheter 60, and is located outside the cavity, and The outer conduit 60 is fixedly connected; the second end 802 of the rotating structure 80 is sleeved on the outside of the power rod 30 , and is located inside the cavity, and drives the power rod 30 to rotate.
  • the opening direction of the through hole 601 of the outer catheter 60 that is, the direction in which the force application end 102 is pulled out, has many possibilities; This possibility facilitates the control of the opening direction of the through hole 601.
  • the outer catheter 60 does not move in the axial direction and the radial direction, but only rotates around the fixed rotation axis; and during the rotation process, the second end 802 moves synchronously with the first end 801, thereby The driving power rod 30 is also rotated synchronously, but the rotation here will not affect the movement of the power rod 30 along the length direction.
  • a slot is provided between the first end 801 and the second end 802, and the slot accommodates a part of the edge of the half-shell 701, so as to play a position-limiting role and make the installation of the entire rotating structure 80 easier.
  • the second end 802 is attached to the power rod 30 through the prismatic through hole to realize the transmission of rotational power.
  • the local position of the power rod 30 matched with the prismatic through hole is a corresponding prism structure, which can be integrally formed with the structure including the first stop 3031, the second stop 3032 and the connecting rod 3033 in the above optimization method, And the whole body is fixedly connected with the end of the main body of the power rod 30, which can also serve the purpose of facilitating processing.
  • the induction structure includes a rod body 7022 drawn from the force application handle 702, and a stepped seat 703 with several stepped structures arranged on the inner wall of the cavity
  • the rod body 7022 is in contact with the step seat 703, and during the rotation of the force applying handle 702, it successively reaches different step structures on the step seat 703 to generate a stuck feeling, and the stuck feeling is transmitted to the operator through the force applying handle 702.
  • the operator can perceive the operation process through the frequency and times of the stuck feeling during the operation, so that the control is more precise.

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Abstract

一种微创手术缝合线端部锁结装置包括：勾线组件（10）、夹紧结构（20）、动力杆（30）和外导管（60）；勾线组件（10）包括由柔性材料围设成的环形结构（101）以及施力端（102）；夹紧结构（20）对锁钉（40）进行挤压；动力杆（30）通过直线运动对夹紧结构（20）进行挤压；外导管（60）设置有通孔（601），通孔（601）设置于夹紧结构（20）和动力杆（30）接触位置一侧，供通过贯通区域（401）的部分缝合线（50）引出。本装置可在缝合线（50）自人体组织引出位置的近端直接对其进行拉紧及锁结，相对于将缝合线（50）自整个锁结装置引出至体外而拉紧而言，更加容易控制缝合线（50）对组织的缝合松紧程度，避免了因缝合线（50）线程过长及其自身弹性而引起的控制难度。还涉及一种微创手术缝合线端部锁结方法及操作枪体。

Description

微创手术缝合线端部锁结装置、方法及操作枪体 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种微创手术缝合线端部锁结装置、方法及操作枪体。
背景技术
在目前的微创手术及介入手术中，需在患者身体上切开一定的创口，以供内窥镜或介入导管等器械伸入人体内部，且在患者体内完成组织缝合以及缝合线端部的固定。
针对缝合线端部的固定方式中，进行多道打结锁紧是较为常规的，即通过相关器械在患者体内通过对缝合线端部的缠绕打结而进行多道锁紧，从而避免后续的松脱。但在手术完结后，由于人体的相关组织在生命活动过程中是运动的，以及，缝合线本身的材质原因，使得缝合线松脱的情况难以完全杜绝。
为了解决上述问题，相关产品的部分生产厂商研究开发了可通过锁钉对缝合线端部进行锁紧的锁结装置，具体地，通过锁钉的弹性形变对缝合线端部进行夹紧，形变后的锁钉贴合于人体组织表面防止缝合线的松脱。
通过现有的锁结装置对缝合线进行拉紧而保证缝合有效性时，需要通过设置于人体外部的可用于拉紧缝合线的结构实现，此种方式下缝合线的线程较长，使得缝合线被拉长的距离较大，因此对于缝合后实际所需的缝合线张紧力控制难度较大。
发明内容
本发明提供了一种微创手术缝合线端部锁结装置，可有效解决背景技术中的问题；同时，本发明中还请求保护一种微创手术缝合线端部锁结方法、一种微创手术缝合线端部锁结操作枪体，具有同样的技术效果。
为了达到上述目的，本发明所采用的技术方案是：
微创手术缝合线端部锁结装置，用于通过锁钉对缝合线端部进行夹紧固定，包括：勾线组件、夹紧结构、动力杆和外导管；
所述勾线组件包括由柔性材料围设成的环形结构，以及相对于所述环形结构引出的施力端；所述环形结构自所述锁钉的贯通区域引出，且引出部分形成封闭区域；所述施力端用于在人体内的外力作用下，通过拉动所述环形结构而带动进入封闭区域的缝合线局部贯穿所述贯通区域；
所述夹紧结构用于对所述锁钉进行挤压，使得所述锁钉形变而夹紧所述缝合线；所述动力杆设置有挤压部，通过直线运动对所述夹紧结构进行挤压，使所述夹紧结构运动而完成挤压动作；
所述夹紧结构和动力杆均安装于所述外导管内，所述锁钉自所述外导管端部插入，且设置于所述锁钉上的止挡结构限制插入的深度；所述外导管设置有通孔，所述通孔设置于所述夹紧结构和动力杆 接触位置一侧，且在相距所述接触位置的设定距离内，供通过所述贯通区域的部分缝合线在环形结构的拉动下引出。
进一步地，所述通孔为一字型孔，且沿所述动力杆的直线运动方向延伸。
进一步地，所述施力端为钩体结构。
进一步地，所述动力杆端部还包括切割部；
所述切割部伴随所述动力杆的挤压运动而靠近所述通孔的一侧侧壁，直至相对于所述通孔的一侧侧壁到达足够近的距离且继续靠近时，所述切割部通过与所述一侧侧壁的边缘的配合，而实现通过所述通孔的缝合线的切割。
进一步地，所述外导管还包括安装于端部的导向座；
所述导向座用于对所述锁钉的插入深度进行限制，以及，对所述夹紧结构的运动提供导向。
进一步地，所述夹紧结构的运动垂直于所述锁钉插入所述导向座的方向。
进一步地，所述导向座上设置有导向槽，所述夹紧结构设置有凸出部分，所述凸出部分沿所述导向槽运动。
进一步地，所述夹紧结构上设置有至少一处朝向所述锁钉的凸起结构，所述凸起结构对所述锁钉局部进行挤压。
进一步地，所述挤压部包括对所述夹紧结构进行挤压的坡面，所述坡面末端形成可插入所述夹紧结构与外导管内壁之间间隙的尖锐结构，所述坡面相对于所述导向座对所述夹紧结构的导向方向倾斜设置。
微创手术缝合线端部锁结方法，采用如上所述的微创手术缝合线端部锁结装置，包括以下步骤：
将所述勾线组件相对于所述锁钉安装到位，以及，将所述锁钉相对于所述外导管安装到位，并伸入身体内指定位置；
牵拉已经完成缝合的缝合线端部，使得所述缝合线的端部进入所述封闭区域内；
牵拉所述施力端，以及，控制所述缝合线的端部，使得所述缝合线部分贯穿所述贯通区域，且保持设定张力范围；
控制所述外导管将所述锁钉挤压于人体组织表面；
通过所述动力杆为所述夹紧结构提供挤压动力，完成所述锁钉对缝合线的夹紧；
裁切所述缝合线，且将与所述缝合线分离的勾线组件、多余的缝合线及锁结装置自人体内移除。
进一步地，控制所述缝合线端部为：在所述锁钉靠近缝合组织的一侧牵拉所述缝合线端部，使得牵拉所述施力端的过程中，所述缝合线偏离端部的位置重叠且贯穿所述锁钉的贯通区域。
进一步地，控制所述缝合线端部为:牵拉所述施力端,通过所述环形结构带动所述缝合线末端贯 穿所述锁钉的贯通区域，在所述锁钉远离缝合组织的一侧牵拉所述缝合线端部。
微创手术缝合线端部锁结操作枪体，包括如上所述的微创手术缝合线端部锁结装置，还包括操作组件，位于人体外部以供操作；
所述操作组件包括对接组装而形成腔体的两半壳体，以及局部安装在所述腔体内的施力手柄，所述施力手柄与所述半壳体转动连接；
所述施力手柄位于所述腔体内的一端与所述动力杆滑动连接，所述外导管外截面为圆柱形，且所述圆柱形的轴线相对于所述半壳体固定设置；所述施力手柄在转动过程中对所述动力杆进行挤压。
进一步地，所述动力杆端部设置有与所述施力手柄滑动连接的连接结构，所述连接结构包括：
沿所述动力杆的长度方向并列设置的第一挡块和第二挡块，所述第一挡块和第二挡块之间通过连杆连接，所述第一挡块相对靠近所述微创手术缝合线端部锁结装置；
所述施力手柄的端部设置有对所述连杆进行容纳的凹槽，所述施力手柄的端部分别与所述第一挡块和第二挡块贴合。
进一步地，所述第一挡块通过球形面与所述施力手柄接触，且所述施力手柄对应设置同向弯曲的曲面与所述球形面贴合。
进一步地，所述施力手柄通过曲面与所述第二挡块接触。
进一步地，还包括转动结构，所述转动结构的第一端套设于所述外导管外部，以及，位于所述腔体外部，且与所述外导管固定连接；所述转动结构的第二端套设于所述动力杆外部，以及，位于所述腔体内部，且带动所述动力杆转动。
进一步地，所述第一端和第二端之间设置有卡槽，所述卡槽对所述半壳体的局部边缘进行容纳。
进一步地，所述第二端通过棱柱形贯通孔与所述动力杆贴合，实现转动动力的传递。
进一步地，所述还包括感应结构，所述感应结构包括自所述施力手柄引出的杆体，以及设置于所述腔体内壁上，且具有若干台阶结构的阶梯座；
所述杆体与所述阶梯座相抵，且在所述施力手柄转动的过程中，依次到达所述阶梯座上的不同台阶结构而产生卡顿感，所述卡顿感通过施力手柄向操作者传递。
通过本发明的技术方案，可实现以下技术效果：
本发明中提供了一种可在缝合线自人体组织引出位置的近端直接对其进行拉紧及锁结的装置，相对于将缝合线自整个锁结装置引出至体外而拉紧而言，更加容易控制缝合线对组织的缝合松紧程度，避免了因缝合线线程过长及其自身弹性而引起的控制难度。本发明中还请求保护一种微创手术缝合线端部锁结方法及操作枪体，通过应用上述装置而获得同样的技术效果。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为微创手术缝合线端部锁结装置除外导管的结构示意图；
图2为锁钉的结构示意图；
图3为勾线组件的环形结构向锁钉的贯通区域内插入的示意图；
图4为图3中插入过程完成后的示意图；
图5为支撑扣的安装示意图；
图6为勾线组件和锁钉相对于外导管安装完成后的示意图；
图7为切割部对缝合线进行切割的过程示意图；
图8为动力杆的端部剖视图；
图9为导向座相对于勾线组件和夹紧结构的安装示意图；
图10为夹紧结构的一种结构示意图；
图11为导向座相对于勾线组件的安装示意图；
图12为两个夹紧结构相对于锁钉的位置示意图；
图13为夹紧结构优化方式的安装位置剖视图；
图14为夹紧结构优化方式的安装示意图；
图15中(a)～(d)为锁钉的四种集中受力位置示意图；
图16为另一种夹紧结构的安装示意图；
图17为微创手术缝合线端部锁结方法的流程图；
图18为缝合线的端部进入封闭区域内的示意图；
图19为缝合线偏离端部的位置重叠且贯穿锁钉的贯通区域的示意图；
图20为缝合线末端贯穿锁钉的贯通区域的示意图；
图21为微创手术缝合线端部锁结操作枪体的结构示意图(仅展示一个半壳体)；
图22为半壳体和施力手柄连接位置处的局部放大图；
图23为图22中A处的局部放大图；
图24为连接结构的位置及结构示意图；
图25为连接结构与施力手柄连接位置处的局部放大图；
图26为图25中B处的局部放大图；
图27为转动结构的位置及结构示意图；
图28为半壳体的结构示意图；
图29为图28中C处的局部放大图；
图30为图25中D处的局部放大图；
附图标记：10、勾线组件；101、环形结构；102、施力端；103、支撑扣；20、夹紧结构；201、凸出部分；202、凸起结构；203、导向面；204、第一夹紧结构；204a、孔位；205、第二夹紧结构；30、动力杆；301、挤压部；3011、坡面；302、切割部；303、连接结构；3031、第一挡块；3032、第二挡块；3033、连杆；40、锁钉；401、贯通区域；402、止挡结构；50、缝合线；501、末端；502、自组织引出端；60、外导管；601、通孔；602、导向座；6021、导向槽；603、堵头；70、操作组件；701、半壳体；702、施力手柄；7021、凹槽；7022、杆体；703、阶梯座；80、转动结构；801、第一端；802、第二端。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
如图1～6所示，微创手术缝合线端部锁结装置，用于通过锁钉40对缝合线50端部进行夹紧固定，包括：勾线组件10、夹紧结构20、动力杆30和外导管60；勾线组件10包括由柔性材料围设成的环形结构101，以及相对于环形结构101引出的施力端102；环形结构101自锁钉40的贯通区域401引出，且引出部分形成封闭区域；施力端102用于在人体内的外力作用下，通过拉动环形结构101而带动进入封闭区域的缝合线50局部贯穿贯通区域401；夹紧结构20用于对锁钉40进行挤压，使得锁钉40形变而夹紧缝合线50；动力杆30设置有挤压部301，通过直线运动对夹紧结构20进行挤压，使夹紧结构20运动而完成挤压动作；夹紧结构20和动力杆30均安装于外导管60内，锁钉40自外导管60端部插入，且通过锁钉端部的止挡结构402限制插入深度；外导管60设置有通孔601，通孔601设置于夹紧结构20和动力杆30接触位置一侧，且在相距接触位置的设定距离内，供通过贯通区域401的部分缝合线50在环形结构101的拉动下引出。
本发明中提供了一种可在缝合线50自人体组织引出位置的近端直接对其进行拉紧及锁结的装置，相对于将缝合线50自整个锁结装置引出至体外而拉紧而言，更加容易控制缝合线50对组织的缝合松紧程度，避免了因缝合线50线程过长及其自身弹性而引起的控制难度。
其中，环形结构101与施力端102的连接优选预先完成，从而作为整体的耗材而参与到后续的操 作中；锁钉40相对于外导管60的连接，优选在与勾线组件10连接完成后进行，勾线组件10与锁钉40的连接如图3和4所示，环形结构101插入锁钉40的贯通区域401即可，其中，施力端102可在锁钉40插入外导管60前首先插入外导管60且通过通孔601引出，随后再将锁钉40插入外导管60，并细致进行环形结构101以及施力端102相对于锁钉40的位置调节；以上的各结构连接过程是一种便于组装及现场使用的具体实施方式，其他能够获得最终使用状态的连接过程也同样在本发明的保护范围内。
以上完成连接的产品形态可直接作为出厂的状态，通过清洁的密封包装而备用，可在拆封后直接使用，而为了避免在运输及进入人体的过程中勾线组件10发生脱落，如图5所示，可设置支撑扣103对自锁钉40引出的环形结构101进行支撑，当然，此处的支撑优选使得环形结构101获得一定的弹性扩张，从而保证与支撑扣103之间的贴合紧密性，也可在支撑扣103上设置槽体等结构对环形结构101进行容纳，支撑扣103在使用前移除即可。
为了降低上述各结构的连接及安装难度，参见图6，通孔601为一字型孔，且沿动力杆30的直线运动方向延伸，从而使得勾线组件10相对于外导管60的位置确定过程更加便于实现，尤其针对施力端102通过通孔601的过程，获得了更大的空间。
作为施力端102的结构形式，以便于在体内操作为优先考虑，基于上述目的，作为一种较佳的实施方式，参见图1和图6，施力端102为钩体结构，此种结构形式可使得现有器械对其的施力更加方便进行，且加工容易。
为了减少操作步骤，缩短手术时间，对动力杆30的结构形式进行优化，具体地，动力杆30端部还包括切割部302；切割部302伴随动力杆30的挤压运动而靠近通孔601的一侧侧壁，直至相对于通孔601的一侧侧壁到达足够近的距离且继续靠近时，切割部302通过与一侧侧壁的边缘的配合，而实现通过通孔601内缝合线50的切割。
其中，切割部302可在动力杆30的加工过程中直接成型，与其相同的，挤压部301也可采用同样的方式获得，从而作为整体结构的动力杆30可在动力供给及切割的过程中保证更好的稳定性，且更加坚固耐用，使得产品的安装难度也同样降低。
如图7所示，展示了切割部302执行切割动作的过程，与动力杆30对于夹紧结构20的挤压过程同步进行，可完全省略对于缝合线50独立的裁切步骤，在挤压和切割前，需要确保缝合线50被牵拉到位，伴随切割部302向通孔601的一侧侧壁靠近，切割部302与通孔601的一侧侧壁形成了近似双刃的结构，针对自二者间经过的缝合线50，当二者之间的挤压力达到一定值，且缝合线50获得一定张力时，切割的目的较易实现。
其中，为了提高切割的效果，可对切割部302的形态进行优化，从而控制由其所提供的切割刃的 锋利程度，动力杆30安装于外导管60内部，不会对患者造成任何的影响，相对于对通孔601侧壁的改进而言具有更大的改进空间。参见图8，其位于动力杆30端部位置，形状可通过后续的加工而控制。
在实际应用过程中，外导管60一侧伸入人体内部，而另一侧位于人体外部，因此长度较长，在其端部直接对夹紧结构20等进行安装的加工难度较大，为了解决此问题，作为一种优化的方式，如图9所示，外导管60还包括安装于端部的导向座602；导向座602用于对锁钉40的插入深度进行限制，以及，对夹紧结构20的运动提供导向。当导向座602与外导管60分离时，可进行夹紧结构20的安装，安装完成后再直接整体安装即可，此处的导向功能可在狭小的空间内实现夹紧结构20的相对固定，以及准确的限制其运动方向。
在手术过程中，除满足锁钉40的安装需求外，外导管60越小的外部尺寸对患者而言是更优的，出于上述目的，夹紧结构20通过更小的运动范围实现对锁钉40更大的挤压程度是更加被需要的，出于上述目的，夹紧结构20的运动垂直于锁钉40插入导向座602的方向。
作为一种具体的导向方式，如图9～11所示，导向座602上设置有导向槽6021，夹紧结构20设置有凸出部分201，凸出部分201沿导向槽6021运动。此种方式是一种最便于实现的方式，且导向稳定。本发明中针对夹紧结构20数量的选择，以外导管60内的安装空间，动力杆30的形状等综合选择，如图12所示，展示了设置两个夹紧结构20的方式，对应的，在动力杆30端部设置两个挤压部301即可。
或者作为夹紧结构20的另外一种实施方式，将夹紧结构20设置为V型夹的形式，如图13和14所示，此处的V型夹具体包括成设定夹角设置的第一夹紧结构204和第二夹紧结构205，且当第一夹紧结构204固定设置时，第二夹紧结构205可在动力杆30的挤压下通过自身的弹性形变，或者通过相对于第一夹紧结构204角度的弹性变化，再或者以上两种情况同时发生，从而向第一夹紧结构204靠近，且当挤压力解除时，可实现弹性的复位。
当采用此种结构形式的夹紧结构20时，只需将锁钉40需要被夹紧的位置设置于二者之间，即可达到被挤压变形的目的。在此种结构形式下，尽可能的延长第一夹紧结构204和第二夹紧结构205的长度可使得上述弹性变化更加相对容易，而为了实现此目的，可在动力杆30的端部设置对夹紧结构20进行部分容纳的凹陷区域以包容其长度的延伸。
而作为此种结构形式下夹紧结构20的一种更加优化的方式，夹紧结构20与用于对外导管60端部进行封堵的堵头603一体成型，从而可使得安装的难度进一步降低，具体地，堵头603与第一夹紧结构204连接；为了使得第一夹紧结构204获得更好的强度，可将其设置为台阶结构，从而使得强度获得提升的同时，还可通过台阶面实现锁钉40的进一步定位，或者其他满足空间要求的异形的形式， 也均在本发明的保护范围内。由于此种结构形式的夹紧结构20在外导管60内所占的位置较大，因此在较大程度上会影响缝合线自通孔601的引出，为了解决此问题，可在第一夹紧结构204上设置与通孔601对应的孔位204a,从而避免干涉情况的发生。在实际操作过程中，即便通过锁钉40对缝合线50进行夹紧固定，在后续人体组织持续运动的过程中，仍然存在脱落的风险，为了将上述风险降到最低，夹紧结构20上设置有至少一处朝向锁钉40的凸起结构202，凸起结构202对锁钉40局部进行挤压。凸起结构202对锁钉40的挤压形式相对于对锁钉40进行整体平压的方式，可形成对于缝合线50更加集中的挤压位置，如图15中箭头所指示的位置，即缝合线50获得集中挤压的位置。图中(a)所示的为通过一处集中挤压而保证缝合线50获得稳定固定的锁钉40的受力位置，当然，除了集中的挤压位置以外，锁钉40的其他位置还是可通过平压的方式而产生形变，从而获得相对于集中挤压位置略小的挤压力；图中(b)展示了夹紧结构20上的凸起结构202大于一处，具体为两处时，锁钉40的集中受力位置，作用与图中(a)处相同，当然，对于缝合线50的固定效果更佳，但是会适当提高夹紧结构20的加工难度；图中(c)中展示了夹紧结构20设置两个，且每个夹紧结构20设置一处凸起结构202而对锁钉40进行挤压时，锁钉40的集中受力位置；图中(d)处展示了夹紧结构20设置两个，且每个夹紧结构20上的凸起结构202大于一处，具体为两处时，锁钉40的集中受力位置，此种方式中优选如图中所示的，将两夹紧结构20上的凸起结构202错位设置，从而可使得被挤压的锁钉40获得近似波浪的最终形态，对于缝合线50的固定效果更优；在上述各个方案中，可根据实际的需要进行选择。在实施过程中，除了凸起结构202之外，还可设置对应的凹陷区域，因凸起结构202而挤压变形的区域可向凹陷区域内形变，如图13中即展示了凹陷区域的设置方式，具体地，凹陷区域可以为夹紧结构20的一部分，或者为外导管60的一部分。
作为上述实施例的优选，参见图8，挤压部301包括对夹紧结构20进行挤压的坡面3011，坡面3011末端形成可插入夹紧结构20与外导管60内壁之间间隙的尖锐结构，坡面3011相对于导向座602对夹紧结构20的导向方向倾斜设置；通过坡面3011的设置，将动力杆30的直线运动转化为夹紧结构20的直线运动，且实现方向的转变。
其中，夹紧结构20为了适应与挤压部301之间的相互挤压，可如图10所示，设置与坡面3011对应的导向面203，或者，如图16所示，直接将夹紧结构20设置为轴体结构，或者具有部分曲面的结构，从而通过曲面与坡面3011产生相互的挤压。
作为上述微创手术缝合线端部锁结装置的锁结方法，具体可参照以下的步骤，从而起到较佳的使用效果，如图17所示，微创手术缝合线端部锁结方法，采用如上所述的微创手术缝合线端部锁结装置，包括以下步骤：
S1：将勾线组件10相对于锁钉40安装到位，以及，将锁钉40相对于外导管60安装到位，并伸 入身体内指定位置；具体可参照图3、4和6，且如上述实施例中的方式，确保封闭区域形成，以及锁钉40相对于夹紧结构20安装到位；
S2：牵拉已经完成缝合的缝合线50端部，使得缝合线50的端部进入封闭区域内；如图18所示，从而使得环形结构101的运动能够向缝合线50传递；
S3：牵拉施力端102，以及，控制缝合线50的端部，使得缝合线50部分贯穿贯通区域401，且保持设定张力范围；其中，牵拉施力端102的目的在于带动缝合线50进入且通过锁钉40的贯通区域401，从而实现被挤压固定的目的，而针对缝合线50端部的控制，目的在于避免操作过程中发生松脱，而影响组织缝合的效果；
S4：控制外导管60将锁钉40挤压于人体组织表面；此位置也正是锁钉40完成锁结后所在的位置，操作过程中此步骤较为重要，对确保缝合的有效性极其关键，在此位置锁紧的缝合线50其张紧程度不会发生变化，而当锁钉40与人体组织表面贴合不到位时，在锁紧完成后，缝合线50会发生松脱，且在锁钉40与人体表面贴合后才可停止；
S5：通过动力杆30为夹紧结构20提供挤压动力，完成锁钉40对缝合线50的夹紧；此过程，操作者需要在人体外部对动力杆30进行施力；
S6：裁切缝合线50，且将与缝合线50分离的勾线组件10、多余的缝合线50及锁结装置自人体内移除。
其中，对于缝合线50端部的控制可包括两种方式：
方式一：如图19所示，控制缝合线50端部为：在锁钉40靠近缝合组织的一侧牵拉缝合线50端部，使得牵拉施力端102的过程中，缝合线50偏离端部的位置重叠且贯穿锁钉40的贯通区域401。
此时，缝合线50的末端501以及缝合线50的自组织引出端502位于锁钉40的一侧，其中，末端501通过器械控制，自组织引出端502受到组织的限制，此过程中通过施力端102对缝合线50进行牵拉，会使得缝合线50形成重叠而使得根数翻倍的部分，此部分在锁钉40的贯通区域401内会受到最终的挤压固定；此种方式中，由于锁钉40内部的缝合线50根数变多，可使得挤压的更加稳定，且在整个过程中末端501均受到器械的固定，有效的避免了缝合线50松脱的问题，但是此种方式中，可能会使得锁钉40的贯通区域401尺寸相对偏大。
方式二：如图20所示，控制缝合线50端部为:牵拉施力端102,通过环形结构101带动缝合线50的末端501贯穿锁钉40的贯通区域401，在锁钉40远离缝合组织的一侧牵拉缝合线50端部。
此种方式下，末端501指缝合线50一定长度范围的端部中位于最边缘的部位；缝合线50的末端501完全通过贯通区域401，此过程完成后，可在锁钉40的另一侧对缝合线50进行牵拉，此过程由于贯穿锁钉40的缝合线50根数较少，因此可降低锁钉40的尺寸，但在末端501贯穿贯通区域401 的过程中，缝合线50可能会发生一定的松脱，但后续可通过端部的牵拉而再次拉紧
以上两种方式均在本发明的保护范围内，可根据实际的需要进行选择。
本发明中的微创手术缝合线端部锁结装置可通过安装于操作枪体上而实现工作，具体如以下实施例：
如图21～23所示，微创手术缝合线端部锁结操作枪体，包括如上所述的微创手术缝合线端部锁结装置，还包括操作组件70，位于人体外部以供操作。
操作组件70包括对接组装而形成腔体的两半壳体701，以及局部安装在腔体内的施力手柄702，施力手柄702与半壳体701转动连接；施力手柄702位于腔体内的一端与动力杆30滑动连接，外导管60外截面为圆柱形，且圆柱形的轴线相对于半壳体701固定设置；施力手柄702在转动过程中对动力杆30进行挤压。
两半壳体701通过现有的固定方式实现对接，且此处的对接可设置为可拆卸的，从而便于内部结构的观察等，针对施力手柄702与半壳体701的转动连接，可通过在施力手柄702上设置轴体，而在半壳体701上设置供轴体插入的孔位来实现，可在两半壳体701对接组装过程中，自然的实现施力手柄702的固定。其中，施力手柄702可采用一体结构，也可为分体组装的结构，可根据实际的生产需要进行选择。
操作中通过控制施力手柄702的沿图22和23中所示的逆时针转动而对动力杆30进行挤压；而当反方向运动时，压力自然解除，即可实现锁钉40相对于外导管60的移除，为了使得在上述移除过程中，锁钉40受到的力减小，如图24和25所示，动力杆30端部设置有与施力手柄702滑动连接的连接结构303，连接结构303包括：
沿动力杆30的长度方向并列设置的第一挡块3031和第二挡块3032，第一挡块3031和第二挡块3032之间通过连杆3033连接，其中，可设置连杆3033与动力杆30平行；施力手柄702的端部设置有对连杆3033进行容纳的凹槽7021，施力手柄702的端部分别与第一挡块3031和第二挡块3032贴合，其中，第一挡块3031相对靠近微创手术缝合线端部锁结装置。
通过此种贴合方式，使得施力手柄702对连接结构303挤压完成而反向转动，使得动力杆30解除对夹紧结构20进行挤压的过程中，可带动动力杆30复位，从而使得与锁钉40接触的夹紧结构20不再受到挤压力的作用，更加便于锁钉40相对于外导管60的移除。
作为上述实施例的优选，如图26所示，第一挡块3031通过球形面与施力手柄702接触，且施力手柄702对应设置同向弯曲的曲面与球形面贴合；球形面与曲面的贴合可在施力手柄702相对于第一挡块3031滑动的过程中，使得滑动更加顺畅，降低硬性摩擦而造成的摩擦表面损伤。其中的球形面可以为圆球形或者椭球形中的一种，但优选是规则的，从而便于加工。施力手柄702上的曲面可适应 球形面的弯曲形式而设置，可随施力手柄702同步成型或者后续加工获得。
作为一种优选方式，施力手柄702通过曲面与第二挡块3032接触；而针对第二挡块3032则并无额外的加工要求，因为在施力手柄702回程的过程中，与第二挡块3032之间的挤压力较小，因此通过施力手柄702的曲面完全可满足二者间顺畅滑动的目的，从而可降低第二挡块3032的加工难度；具体地，可将第二挡块3032设置为圆形片体，且在腔体内部设置阻挡结构，可限制其回程的极限位置。第一挡块3031、第二挡块3032和连杆3033所组成的组合结构可一体成型，且在独立完成加工后，与动力杆30主体进行连接，从而获得动力杆30的完整结构，此种方式较为简单，且形状更加容易控制。
作为上述实施例的优选，微创手术缝合线端部锁结操作枪体还包括转动结构80，转动结构80的第一端801套设于外导管60外部，以及，位于腔体外部，且与外导管60固定连接；转动结构80的第二端802套设于动力杆30外部，以及，位于腔体内部，且带动动力杆30转动。
在通过操作枪体进行锁结操作过程中，由于人体内部的空间有限，为躲避人体组织结构，外导管60的通孔601开设方向，即施力端102的引出方向是存在多种可能的；为了适应此种可能性，便于对通孔601开设方向进行控制，如图27所示，本优选方案中设置了转动结构80，通过第一端801的控制，操作者对外导管60进行转动，当然，在转动的过程中，外导管60在轴向方向和径向方向上并不发生移动，而仅仅围绕固定的转轴转动；而在转动的过程中，第二端802同第一端801同步运动，从而带动动力杆30也同步转动，但此处的转动并不会影响动力杆30沿长度方向的运动。在上述转动的过程中，优选与上述第一挡块3031通过球形面与施力手柄702接触的优化结构相配合，从而使得转动更加顺畅。
其中，第一端801和第二端802之间设置有卡槽，卡槽对半壳体701的局部边缘进行容纳，从而起到限位的作用，而使得整个转动结构80的安装更加简单。第二端802通过棱柱形贯通孔与动力杆30贴合，实现转动动力的传递。与棱柱形贯通孔配合的动力杆30局部位置为对应的棱柱体结构，此结构可与上述优化方式中包括第一挡块3031、第二挡块3032和连杆3033在内的结构一体成型，而整体与动力杆30主体的端部固定连接，同样可起到便于加工的目的。
作为上述实施例的优选，还包括感应结构，如图28～30所示，感应结构包括自施力手柄702引出的杆体7022，以及设置于腔体内壁上，且具有若干台阶结构的阶梯座703；杆体7022与阶梯座703相抵，且在施力手柄702转动的过程中，依次到达阶梯座703上的不同台阶结构而产生卡顿感，卡顿感通过施力手柄702向操作者传递。通过此种结构形式，可使得操作者在操作的过程中，通过卡顿感的产生频率和次数对操作过程进行感知，从而使得控制更加精准。
以上显示和描述了本发明的基本原理、主要特征及优点。本行业的技术人员应该了解，本发明不 受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。

Claims (20)

  1. 微创手术缝合线端部锁结装置，用于通过锁钉对缝合线端部进行夹紧固定，其特征在于，包括：勾线组件、夹紧结构、动力杆和外导管；
    所述勾线组件包括由柔性材料围设成的环形结构，以及相对于所述环形结构引出的施力端；所述环形结构自所述锁钉的贯通区域引出，且引出部分形成封闭区域；所述施力端用于在人体内的外力作用下，通过拉动所述环形结构而带动进入封闭区域的缝合线局部贯穿所述贯通区域；
    所述夹紧结构用于对所述锁钉进行挤压，使得所述锁钉形变而夹紧所述缝合线；所述动力杆设置有挤压部，通过直线运动对所述夹紧结构进行挤压，使所述夹紧结构运动而完成挤压动作；
    所述夹紧结构和动力杆均安装于所述外导管内，所述锁钉自所述外导管端部插入，且设置于所述锁钉上的止挡结构限制插入的深度；所述外导管设置有通孔，所述通孔设置于所述夹紧结构和动力杆接触位置一侧，且在相距所述接触位置的设定距离内，供通过所述贯通区域的部分缝合线在所述环形结构的拉动下引出。
  2. 根据权利要求1所述的微创手术缝合线端部锁结装置，其特征在于，所述通孔为一字型孔，且沿所述动力杆的直线运动方向延伸。
  3. 根据权利要求1所述的微创手术缝合线端部锁结装置，其特征在于，所述施力端为钩体结构。
  4. 根据权利要求1所述的微创手术缝合线端部锁结装置，其特征在于，所述动力杆端部还包括切割部；
    所述切割部伴随所述动力杆的挤压运动而靠近所述通孔的一侧侧壁，直至相对于所述通孔的一侧侧壁到达足够近的距离且继续靠近时，所述切割部通过与所述一侧侧壁的边缘的配合，而实现通过所述通孔的缝合线的切割。
  5. 根据权利要求1所述的微创手术缝合线端部锁结装置，其特征在于，所述外导管还包括安装于端部的导向座；
    所述导向座用于对所述锁钉的插入深度进行限制，以及，对所述夹紧结构的运动提供导向。
  6. 根据权利要求5所述的微创手术缝合线端部锁结装置，其特征在于，所述夹紧结构的运动垂直于所述锁钉插入所述导向座的方向。
  7. 根据权利要求5所述的微创手术缝合线端部锁结装置，其特征在于，所述导向座 上设置有导向槽，所述夹紧结构设置有凸出部分，所述凸出部分沿所述导向槽运动。
  8. 根据权利要求1所述的微创手术缝合线端部锁结装置，其特征在于，所述夹紧结构上设置有至少一处朝向所述锁钉的凸起结构，所述凸起结构对所述锁钉局部进行挤压。
  9. 根据权利要求5所述的微创手术缝合线端部锁结装置，其特征在于，所述挤压部包括对所述夹紧结构进行挤压的坡面，所述坡面末端形成可插入所述夹紧结构与外导管内壁之间间隙的尖锐结构，所述坡面相对于所述导向座对所述夹紧结构的导向方向倾斜设置。
  10. 微创手术缝合线端部锁结方法，其特征在于，采用如权利要求1～9中任一项所述的微创手术缝合线端部锁结装置，其特征在于，包括以下步骤：
    将所述勾线组件相对于所述锁钉安装到位，以及，将所述锁钉相对于所述外导管安装到位，并伸入身体内指定位置；
    牵拉已经完成缝合的缝合线端部，使得所述缝合线的端部进入所述封闭区域内；
    牵拉所述施力端，以及，控制所述缝合线的端部，使得所述缝合线部分贯穿所述贯通区域，且保持设定张力范围；
    控制所述外导管将所述锁钉挤压于人体组织表面；
    通过所述动力杆为所述夹紧结构提供挤压动力，完成所述锁钉对缝合线的夹紧；
    裁切所述缝合线，且将与所述缝合线分离的勾线组件、多余的缝合线及锁结装置自人体内移除。
  11. 根据权利要求10所述的微创手术缝合线端部锁结方法，其特征在于，控制所述缝合线端部为：在所述锁钉靠近缝合组织的一侧牵拉所述缝合线端部，使得牵拉所述施力端的过程中，所述缝合线偏离端部的位置重叠且贯穿所述锁钉的贯通区域。
  12. 根据权利要求10所述的微创手术缝合线端部锁结方法，其特征在于，控制所述缝合线端部为:牵拉所述施力端,通过所述环形结构带动所述缝合线末端贯穿所述锁钉的贯通区域，在所述锁钉远离缝合组织的一侧牵拉所述缝合线端部。
  13. 微创手术缝合线端部锁结操作枪体，其特征在于，包括如权利要求1～9中任一项所述的微创手术缝合线端部锁结装置，还包括操作组件，位于人体外部以供操作；
    所述操作组件包括对接组装而形成腔体的两半壳体，以及局部安装在所述腔体内的施力手柄，所述施力手柄与所述半壳体转动连接；
    所述施力手柄位于所述腔体内的一端与所述动力杆滑动连接，所述外导管外截面为圆柱形，且所述圆柱形的轴线相对于所述半壳体固定设置；所述施力手柄在转动过程中对所述动力杆进行挤压。
  14. 根据权利要求13所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述动力杆端部设置有与所述施力手柄滑动连接的连接结构，所述连接结构包括：
    沿所述动力杆的长度方向并列设置的第一挡块和第二挡块，所述第一挡块和第二挡块之间通过连杆连接，所述第一挡块相对靠近所述微创手术缝合线端部锁结装置；
    所述施力手柄的端部设置有对所述连杆进行容纳的凹槽，所述施力手柄的端部分别与所述第一挡块和第二挡块贴合。
  15. 根据权利要求14所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述第一挡块通过球形面与所述施力手柄接触，且所述施力手柄对应设置同向弯曲的曲面与所述球形面贴合。
  16. 根据权利要求14所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述施力手柄通过曲面与所述第二挡块接触。
  17. 根据权利要求13所述的微创手术缝合线端部锁结操作枪体，其特征在于，还包括转动结构，所述转动结构的第一端套设于所述外导管外部，以及，位于所述腔体外部，且与所述外导管固定连接；所述转动结构的第二端套设于所述动力杆外部，以及，位于所述腔体内部，且带动所述动力杆转动。
  18. 根据权利要求17所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述第一端和第二端之间设置有卡槽，所述卡槽对所述半壳体的局部边缘进行容纳。
  19. 根据权利要求17所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述第二端通过棱柱形贯通孔与所述动力杆贴合，实现转动动力的传递。
  20. 根据权利要求13所述的微创手术缝合线端部锁结操作枪体，其特征在于，所述还包括感应结构，所述感应结构包括自所述施力手柄引出的杆体，以及设置于所述腔体内壁上，且具有若干台阶结构的阶梯座；
    所述杆体与所述阶梯座相抵，且在所述施力手柄转动的过程中，依次到达所述阶梯座上的不同台阶结构而产生卡顿感，所述卡顿感通过施力手柄向操作者传递。
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