WO2024197849A1 - Dispositif d'agrafage de tissu circulaire - Google Patents

Dispositif d'agrafage de tissu circulaire Download PDF

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Publication number
WO2024197849A1
WO2024197849A1 PCT/CN2023/085580 CN2023085580W WO2024197849A1 WO 2024197849 A1 WO2024197849 A1 WO 2024197849A1 CN 2023085580 W CN2023085580 W CN 2023085580W WO 2024197849 A1 WO2024197849 A1 WO 2024197849A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
fixing member
staple
assembly
anvil
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2023/085580
Other languages
English (en)
Chinese (zh)
Inventor
陈亚
吴永友
彭巍
邢春根
赵奎
李根发
刘延俊
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Suzhou Krasmann Medical Technology Co Ltd
Original Assignee
Suzhou Krasmann Medical Technology Co Ltd
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 Suzhou Krasmann Medical Technology Co Ltd filed Critical Suzhou Krasmann Medical Technology Co Ltd
Publication of WO2024197849A1 publication Critical patent/WO2024197849A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a circular tissue suturing device.
  • the circular tissue suturing device is a commonly used tool during surgery.
  • the related technology pre-installs a fixed reinforcing gasket in the stapler before suturing.
  • the existing circular anastomosis device is provided with a connecting line and an elastic sheet, and the reinforcing gasket is tightly attached to the stapler stapler by using the elastic sheet, and the reinforcing gasket and the elastic sheet are pre-sutured by the connecting line; before the surgical anastomosis, the reinforcing gasket and the elastic sheet are separated by pulling the connecting line, and the elastic sheet is pulled out of the body, so as to fix the reinforcing gasket on the anastomosis.
  • it is inconvenient to remove the elastic sheet during the operation which leads to the problem of tearing the anastomosis when the anastomosis device is pulled out after the anastomosis.
  • the present application provides an improved circular tissue suturing device.
  • the present application provides a circular tissue suturing device, including a staple magazine assembly, a staple anvil assembly, a first tissue fixer and a second tissue fixer; the first tissue fixer is detachably connected to the staple magazine assembly; the second tissue fixer is fixedly connected to the staple anvil assembly; the staple magazine assembly is provided with a staple magazine, and a plurality of staple accommodating magazines matching staples are provided in the staple magazine, and the first tissue fixer is arranged on the end side of the staple magazine; when the staple anvil assembly and the staple magazine assembly are in cooperation, the first tissue fixer and the second tissue fixer are placed between the staple anvil assembly and the staple magazine assembly, and the first tissue fixer and the second tissue fixer are fixedly connected by the staples.
  • the nail magazine assembly includes a nail magazine; the nail magazine is provided with a nail outlet portion; the nail outlet portion is provided with at least one limiting groove; and the first tissue fixing member is fixedly connected to the limiting groove.
  • first tissue fixing member is fixedly connected to the staple cartridge assembly.
  • first tissue fixator is provided with at least one first split fracture structure
  • second tissue fixator is provided with at least one second split fracture structure
  • first segmentation fracture structure is the same as the second segmentation fracture structure.
  • a reinforcement portion is provided on the first tissue fixing member, and the reinforcement portion is protruded toward a side away from the anvil assembly.
  • the nail magazine assembly also includes an ejector; the nail magazine is provided with an ejector assembly groove; and the ejector is installed in the ejector assembly groove.
  • the ejector is provided with a plurality of circumferentially arranged staple ejection blocks; the staple accommodating chamber is provided at the ejection end of the staple ejection block; the staple ejection portion is also provided with a plurality of staple ejection openings, and the staple ejection openings correspond one-to-one to the positions of the staple ejection blocks.
  • a gasket pushing block is also provided on the pusher, and the pusher can drive the gasket pushing block to move relative to the staple magazine along the staple pushing direction; under the push of the gasket pushing block, the first tissue fixing member can be separated from the staple magazine assembly.
  • the gasket pushing block is arranged in the limiting groove.
  • the nail magazine assembly also includes an annular cutting knife, and the nail magazine is also provided with a cutting knife mounting groove, and the annular cutting knife is installed in the cutting knife mounting groove.
  • the circular tissue suturing device also includes an operating mechanism, which is transmission-connected to the ejector; the operating mechanism can drive the ejector to move, so that the staple ejection block can reciprocate between a preset ejection position and a preset retracted position.
  • annular cutting knife is transmission-connected to the operating mechanism; the operating mechanism can drive the annular cutting knife to reciprocate in the cutting direction.
  • the operating mechanism can be transmission-connected to the anvil assembly; the operating mechanism can drive the anvil assembly to move axially relative to the nail magazine assembly until the anvil assembly and the nail magazine assembly reach a matching state; the operating mechanism can drive the anvil assembly to move axially in coordination with the nail magazine assembly.
  • a connecting rod is also provided on the nail anvil assembly; one end of the connecting rod is fixed to the bottom of the annular inner cavity, and the other end of the connecting rod is used for transmission connection with the operating mechanism.
  • the present application ensures the reliability of the connection between the first tissue fixer and the staple cartridge assembly before the operation by detachably connecting the first tissue fixer and the staple cartridge assembly.
  • the staples can fix the first tissue fixer to the tissue, thereby improving the connection strength of the anastomosis.
  • the first tissue fixer fills the gap between the staples and the tissue, thereby reducing the phenomenon of anastomotic bleeding, exudation and anastomotic tearing, thereby reducing the occurrence of postoperative complications, thereby improving the success rate of the operation.
  • the present application avoids the risk of the second tissue fixer being detached from the anvil assembly before surgery by fixedly connecting the second tissue fixer to the anvil assembly.
  • the second tissue fixer is arranged at the end side of the anvil assembly, and the second tissue fixer is arranged toward the first tissue fixer.
  • the staples can fix the first tissue fixer and the second tissue fixer on the tissue at the anastomosis, thereby improving the connection strength of the anastomosis, thereby reducing the phenomenon of anastomotic tearing.
  • the first tissue fixer and the second tissue fixer fill the gap between the staple and the tissue, thereby avoiding the risk of bleeding and exudation at the anastomosis, reducing complications, and thus reducing surgical risks.
  • At least one first split fracture structure is provided on the first tissue fixing member, and at least one second split fracture structure is provided on the second tissue fixing member.
  • the anastomosis can have a certain amount of expansion under the action of tissue tension on the basis of reinforcing the tissue, thereby facilitating the removal of the anvil assembly from the anastomosis, thereby avoiding the risk of anastomotic tearing during the process of removing the anvil assembly, thereby improving the success rate of the operation.
  • the first split fracture structure and the second split fracture structure are arranged in the same structure, and when the anvil assembly and the staple magazine assembly are anastomosed, the position of the first split fracture structure is relative to the position of the second split fracture structure, so that under the action of tissue tension, the size and direction of the first tissue fixing part and the second tissue fixing part separated from the corresponding first split fracture structure and the second split fracture structure can be consistent, thereby ensuring the consistency of the separation amount at the first split fracture structure and the second split fracture structure, avoiding the risk of anastomotic tearing due to misaligned separation of the first tissue fixing part and the second tissue fixing part, thereby improving the success rate of the operation.
  • the first tissue fixer also includes a reinforcement portion protruding toward the side away from the nail outlet portion, and the end side of the first segmentation portion is connected to the reinforcement portion.
  • the reinforcement portion on the first tissue fixer can limit the expansion degree of the anastomosis under the action of tissue tension, thereby improving the connection strength of the first tissue fixer itself, thereby enhancing the connection strength of the anastomosis, avoiding the risk of anastomotic tearing, and thus improving the success rate of the operation.
  • At least one limiting groove is provided on the nail outlet portion of the nail magazine, and the first tissue fixing member is fixedly connected to the limiting groove, thereby improving the stability of the fixed connection between the first tissue fixing member and the nail magazine, preventing the first tissue fixing member from being unreliably connected to the nail magazine before the operation and falling off the nail magazine, thereby improving the tissue reinforcement effect of the first tissue fixing member on the anastomotic stoma, thereby reducing bleeding and exudation at the anastomotic stoma, improving the success rate of the operation, and reducing complications.
  • a plurality of circumferentially arranged staple pushing blocks are provided on the pusher, a staple accommodating bin is provided at the pushing end of the staple pushing block, a plurality of staple outlets are provided on the staple outlet portion, and the positions of the staple outlets correspond one to one to the positions of the staple pushing blocks.
  • the plurality of staple pushing blocks can simultaneously push a plurality of staples out of the staple outlets, thereby achieving suturing of the staple outlets through the abutment between the staples and the anvil assembly.
  • a gasket push-out block is arranged on the push-out device, and the push-out device can drive the gasket push-out block to move relative to the staple cartridge along the staple push-out direction.
  • the first tissue fixing member can be smoothly separated from the staple cartridge assembly, thereby avoiding the first tissue fixing member and the staple cartridge assembly from being separated poorly, resulting in the staples tearing and damaging the first tissue fixing member, thereby improving the first tissue fixing member and the tissue fixing member.
  • the flatness of the fit is improved, so that the first tissue fixing member is fixedly connected to the tissue through the staples, thereby improving the reinforcement effect of the first tissue fixing member on the tissue.
  • FIG1 is a cross-sectional view of the overall structure of a circular tissue suturing device provided in an embodiment of the present application
  • FIG2 is a cross-sectional view of the overall structure of another circular tissue suturing device provided in an embodiment of the present application.
  • FIG3 is an exploded view of the overall structure of a circular tissue suturing device provided in an embodiment of the present application.
  • FIG4 is a schematic structural diagram of a staple push-out block and a gasket push-out block in a push-out state provided in an embodiment of the present application;
  • FIG5 is a schematic structural diagram of a staple cartridge assembly provided in an embodiment of the present application.
  • FIG6 is a cross-sectional view of a staple cartridge assembly provided in an embodiment of the present application.
  • FIG7 is a schematic structural diagram of a first tissue fixing member provided in an embodiment of the present application.
  • FIG8 is a schematic structural diagram of another first tissue fixing member provided in an embodiment of the present application.
  • FIG9 is a schematic structural diagram of a second tissue fixing member in a separated state provided by an embodiment of the present application.
  • FIG10 is a schematic diagram of the overall structure of the ejector provided in an embodiment of the present application.
  • FIG11 is a schematic diagram of the structure of a staple cartridge provided in an embodiment of the present application.
  • FIG12 is a cross-sectional view of the overall structure of the nail anvil assembly provided in an embodiment of the present application.
  • FIG13 is a schematic diagram of the structure of an annular knife anvil provided in an embodiment of the present application.
  • FIG14 is a partial enlarged view of A in the annular knife anvil structure provided in an embodiment of the present application.
  • FIG15 is a schematic diagram of a limiting groove structure provided in an embodiment of the present application.
  • FIG16 is a schematic diagram of another limiting groove structure provided in an embodiment of the present application.
  • FIG17 is a schematic diagram of a gasket push-out block structure provided in an embodiment of the present application.
  • FIG18 is a schematic diagram of another gasket push-out block structure provided in an embodiment of the present application.
  • FIG19 is a schematic diagram of another limiting groove structure provided in an embodiment of the present application.
  • FIG20 is a schematic diagram of a structure of a limiting groove and a gasket push-out block provided in an embodiment of the present application
  • This embodiment provides a circular tissue suturing device, including a staple magazine assembly 1, a staple anvil assembly 2, a first tissue fixer 3 and a second tissue fixer 4; the first tissue fixer 3 is detachably connected to the staple magazine assembly 1; the second tissue fixer 4 is fixedly connected to the staple anvil assembly 2; the staple magazine assembly 1 is provided with a staple magazine 11, and a plurality of staple accommodating bins 123 matching with staples are provided in the staple magazine 11, and the first tissue fixer 3 is arranged on the end side of the staple magazine 11; when the staple anvil assembly 2 is matched with the staple magazine assembly 1, the first tissue fixer 3 and the second tissue fixer 4 are placed between the staple anvil assembly 2 and the staple magazine assembly 1, and the first tissue fixer 3 and the second tissue fixer 4 are fixedly connected by the staples.
  • the first tissue fixing member 3 may be a ring-shaped structure.
  • the inner diameter of the first tissue fixing member 3 is consistent with the inner diameter of the staple cartridge assembly 1 in size and shape.
  • the staples can fix the first tissue fixing member 3 to the tissue, thereby improving the connection strength of the anastomosis, and at the same time, the gap between the staples and the tissue is filled by the first tissue fixing member 3, thereby reducing the phenomenon of anastomotic bleeding, exudation and anastomotic tearing, thereby reducing the occurrence of postoperative complications, thereby improving the success rate of the operation.
  • the thickness of the first tissue fixation member 3 is selected to be 0.02-1.6 mm.
  • the thickness of the first tissue fixation member 3 is selected to be 0.05-1 mm.
  • the surface smoothness of the first tissue fixer 3 is 0.2-70S, preferably, 1-30S; the bending stiffness of the first tissue fixer 3 is 0.02-7mN*m, preferably, the bending stiffness of the first tissue fixer 3 is 0.04-1mN*m, the air permeability of the first tissue fixer 3 is 0.2 ⁇ 300 ⁇ m/(Pa ⁇ s), preferably, the air permeability of the first tissue fixer 3 is 1 ⁇ 200 ⁇ m/(Pa ⁇ s), the tensile strength of the first tissue fixer 3 is 0.02-22KN/m; preferably, the tensile strength of the first tissue fixer 3 is 0.1-5KN/m; the elongation at break of the first tissue fixer 3 is 2%-220%, preferably, the elongation at break of the first tissue fixer 3 is 10%-150%.
  • the first tissue fixing element 3 is preferably a synthetic material of poly(lactide-glycolide) (PLGA) or poly(glycolide) (PGA).
  • PLGA poly(lactide-glycolide)
  • PGA poly(glycolide)
  • the circular tissue suturing device further comprises a second tissue fixer 4, which is disposed at the end side of the anvil assembly 2 and is disposed toward the first tissue fixer 3; the second tissue fixer 4 is fixedly connected to the anvil assembly 2.
  • the second tissue fixing member 4 may be a ring-shaped structure.
  • the material of the second tissue fixing member 4 is preferably a synthetic material poly(lactide-glycolide) (PLGA) or poly(glycolide) (PGA).
  • the material of the second tissue fixing member 4 is the same as that of the first tissue fixing member 3 .
  • the thickness of the second tissue fixing member 4 is selected to be 0.02-1.6 mm.
  • the thickness of the second tissue fixing member 4 is selected to be 0.05-1 mm.
  • the second tissue fixing member 4 and the first tissue fixing member 3 are configured to have the same thickness.
  • the performance parameters of the second tissue fixer 4 are as follows: the surface smoothness of the second tissue fixer 4 is 0.2-70S, preferably, the surface smoothness of the second tissue fixer 4 is 1-30S; the bending stiffness of the second tissue fixer 4 is 0.02-7mN*m, preferably, the bending stiffness of the second tissue fixer 4 is 0.04-1mN*m, the air permeability of the second tissue fixer 4 is 0.2 ⁇ 300 ⁇ m/(Pa ⁇ s), preferably, the air permeability of the second tissue fixer 4 is 1 ⁇ 200 ⁇ m/(Pa ⁇ s), the tensile strength of the second tissue fixer 4 is 0.02-22KN/m; preferably, the tensile strength of the second tissue fixer 4 is 0.1-5KN/m; the elongation at break of the second tissue fixer 4 is 2%-220%, preferably, the elongation at break of the second tissue fixer 4 is 10%-150%.
  • the performance parameters of the second tissue fixing member 4 are set to be the same as the performance parameters of the first tissue fixing member 3 .
  • the anvil assembly 2 includes an anvil body 22 and at least one fixing member 23.
  • At least one fixing member matching hole 221 is provided on the side wall of the anvil body 22.
  • One end of the fixing member 23 can pass through the fixing member matching hole 221, and the other end of the fixing member 23 is provided on the outside of the anvil body 22.
  • At least one end of the fixing member 23 extends toward the second tissue fixing member 4 and is fixedly connected to the second tissue fixing member 4 .
  • both ends of the fixing member 23 extend toward the second tissue fixing member 4 and are fixedly connected to the second tissue fixing member 4 respectively.
  • an anvil abutting surface 222 is provided on the anvil body 22, and a tissue bonding surface and a pressing surface opposite to the tissue contact surface are provided on one side of the second tissue fixing piece 4.
  • the fixing piece 23 is fixedly connected to the second tissue fixing piece 4, the pressing surface of the second tissue fixing piece 4 is in contact with the anvil abutting surface 222.
  • the staples can fix the first tissue fixer 3 and the second tissue fixer 4 on the tissue at the anastomosis, thereby improving the connection strength of the anastomosis, thereby reducing the phenomenon of anastomotic tearing, and filling the space between the staples and the tissues through the first tissue fixer 3 and the second tissue fixer 4.
  • the anvil assembly 2 includes a plurality of fixing members 23 , and a plurality of fixing member matching holes 221 are provided on the side wall of the anvil body 22 .
  • the plurality of fixing members 23 correspond to the plurality of fixing member matching holes 221 one by one.
  • the fixing member 23 and the second tissue fixing member 4 can be integrally fixedly connected by suturing, gluing or ultrasonic techniques.
  • the material of the fixing part 23 can be a biological material, such as the pericardial matrix, dermal matrix, small intestinal submucosal matrix, etc. without antigens, or a synthetic material, such as polylactide (PLA), poly(lactide-glycolide) (PLGA), polyglycolide (PGA), polycaprolactone (PCL), para-dioxanone (PDO), etc., or an absorbable suture of different materials, such as polyglycolide monofilament, coated multi-strand polyglycolide suture, catgut, etc., preferably, the same material as the second tissue fixing part 4.
  • a biological material such as the pericardial matrix, dermal matrix, small intestinal submucosal matrix, etc. without antigens
  • a synthetic material such as polylactide (PLA), poly(lactide-glycolide) (PLGA), polyglycolide (PGA), polycaprolactone (PCL), para-dioxanone (PDO
  • the width of the fixing member 23 is in the range of 0.03-120 mm, preferably, the width of the fixing member 23 is in the range of 0.1-50 mm; the thickness of the fixing member 23 is in the range of 0.02-1.6 mm, preferably, the thickness of the fixing member 23 is in the range of 0.05-1 mm.
  • the width of the fixing piece 23 is smaller than the width of the side wall fixing piece matching hole 221 of the nail anvil body 22, and smaller than the width of the connecting hole 242 on the annular knife anvil 24.
  • the thickness of the fixing piece 23 is smaller than the thickness of the fixing piece matching hole 221, and the thickness of the fixing piece 23 is smaller than the thickness of the connecting hole 242.
  • a plurality of fixing members 23 are sequentially passed through the corresponding fixing member matching holes 221 and then fixedly connected to the second tissue fixing member 4, thereby improving the connection strength between the second tissue fixing member 4 and the anvil body 22, thereby improving the flatness of the abutting surface of the second tissue fixing member 4 and the abutting surface 222 of the anvil, thereby improving the suture connection strength of the anastomosis.
  • the anvil assembly 2 includes four fixing members 23 , and four fixing member matching holes 221 are provided on the side wall of the anvil body 22 .
  • the four fixing member matching holes 221 are equidistantly distributed along the circumferential direction of the side wall of the anvil body 22 .
  • the binding force between the fixing member 23 and the second tissue fixing member 4 is required to be greater than 0.2N.
  • the binding force between the fixing member 23 and the second tissue fixing member 4 is required to be greater than 0.5N.
  • the YY/T1797-2021 swing test method can be selected through the qualitative detection method of the bonding force, and it is required that the second tissue fixator 4 is close to the anvil abutment surface 222 of the anvil assembly 2, is not separated from the anvil assembly 2, and the second tissue fixator 4 is not lifted.
  • the method for quantitatively detecting the binding force may be to fix the second tissue fixing piece 4 to be tested on the surface of the testing table, use the micro-hook of the tensile strength tester to tighten the fixing piece 23, and pull it upward at a speed of 1 mm/min perpendicular to the surface of the testing table until at least one of the second tissue fixing pieces 4 is separated from the binding point of the fixing piece 23, and record the maximum value, which is the binding force of the fixing point.
  • At least one first split fracture structure 31 is provided on the first tissue fixation member 3, and at least one second split fracture structure 41 is provided on the second tissue fixation member 4; when the anvil assembly 2 and the nail magazine assembly 1 are in anastomosed connection, the position of the first split fracture structure 31 is opposite to the position of the second split fracture structure 41.
  • a plurality of first segmentation fracture structures 31 may be provided on the first tissue fixing component 3 , and the plurality of first segmentation fracture structures 31 may be evenly spaced along the circumference of the first tissue fixing component 3 .
  • a plurality of second segmentation fracture structures 41 may be provided on the second tissue fixing member 4 , and the plurality of second segmentation fracture structures 41 may be evenly spaced along the circumference of the second tissue fixing member 4 .
  • first segmentation fracture structures 31 are provided on the first tissue fixation component 3
  • second segmentation fracture structures 41 are provided on the second tissue fixation component 4 .
  • the positions of the first segmentation fracture structures 31 are opposite to the positions of the second segmentation fracture structures 41 .
  • the first tissue fixer 3 is a concentric circle structure
  • the first split fracture structure 31 may penetrate the outer circle of the gasket first tissue fixer 3 and the inner circle of the first tissue fixer 3, or may not penetrate.
  • the first split fracture structure 31 penetrates the outer circle of the gasket first tissue fixer 3 and the inner circle of the first tissue fixer 3.
  • the first segmentation fracture structure 31 may be a breakpoint type, a straight line type or a curved line type.
  • the first segmentation fracture structure 31 is a straight line type.
  • At least one first split fracture structure 31 is provided on the first tissue fixing member 3, and at least one second split fracture structure 41 is provided on the second tissue fixing member 4.
  • the position of the first split fracture structure 31 is opposite to the position of the second split fracture structure 41.
  • the anastomosis can have a certain amount of expansion under the action of tissue tension on the basis of reinforcing the tissue, thereby facilitating the removal of the anvil assembly 2 from the anastomosis, thereby avoiding the risk of anastomotic tearing during the process of removing the anvil assembly 2, thereby improving the success rate of the operation.
  • the second tissue fixing piece 4 comprises a connecting portion 43 and a gasket body 42 .
  • the connecting portion 43 is disposed on at least one of the inner edge and the outer edge of the gasket body 42 .
  • the connecting portion 43 is disposed toward the side away from the first tissue fixing piece 3 .
  • a connecting portion 43 is disposed on both the inner circle edge and the outer circle edge of the gasket body 42 , and the connecting portion 43 is disposed toward a side away from the first tissue fixing component 3 .
  • connection portion 43 may be semicircular, semi-elliptical, triangular, polygonal or irregular.
  • the second segmentation fracture structure 41 may penetrate the outer circle of the gasket second tissue fixer 4 and the inner circle of the second tissue fixer 4, or may not penetrate.
  • the second segmentation fracture structure 41 penetrates the outer circle of the gasket second tissue fixer 4 and the inner circle of the second tissue fixer 4.
  • the second segmentation fracture structure 41 may be a breakpoint type, a straight line type or a curved line type.
  • the second segmentation fracture structure 41 is a straight line type.
  • the connecting portion 43 is disposed at the second segmentation fracture structure 41 of the second tissue fixing member 4 , and the connecting portion 43 connects the entity parts at both sides of the second tissue fixing member 4 .
  • first segmentation fracture structure 31 and the second segmentation fracture structure 41 have the same structure.
  • the first segmentation fracture structure 31 may be a breakpoint type, a straight line type or a curve type.
  • the first segmentation fracture structure 31 is a linear structure.
  • the first split fracture structure 31 and the second split fracture structure 41 by setting the first split fracture structure 31 and the second split fracture structure 41 to have the same structure, and when the anvil assembly 2 and the staple magazine assembly 1 are anastomosed and connected, the position of the first split fracture structure 31 is opposite to the position of the second split fracture structure 41, it can be ensured that under the action of tissue tension, the first tissue fixing member 3 and the second tissue fixing member 4 are separated from the corresponding first split fracture structure 31 and the second split fracture structure 41 in a consistent size and direction, thereby ensuring the consistency of the separation amount at the first split fracture structure 31 and the second split fracture structure 41, avoiding the risk of anastomotic tearing due to misaligned separation of the first tissue fixing member 3 and the second tissue fixing member 4, thereby improving the success rate of the operation.
  • the structures of the first dividing fracture structure 31 and the second dividing fracture structure 41 may also be different.
  • the first tissue fixing member 3 further includes a reinforcing portion 32 protruding toward a side away from the nail-out portion; an end side of the first segmentation fracture structure 31 is connected to the reinforcing portion 32 .
  • the reinforcement part 32 may be a reinforcement ring structure.
  • the shape, size and number of the reinforcement part 32 are not limited.
  • the first tissue fixer 3 can be a concentric circle structure, and the outer diameter of the first tissue fixer 3 can be consistent with the outer diameter of the staple magazine 11, or slightly smaller or larger. Preferably, the outer diameter of the first tissue fixer 3 is consistent with the outer diameter of the staple magazine 11.
  • the inner diameter of the first tissue fixator 3 may be consistent with the inner diameter of the staple cartridge 11 , or slightly smaller or larger.
  • the inner diameter of the first tissue fixator 3 is consistent with the inner diameter of the staple cartridge 11 .
  • a reinforcement portion 32 is provided at one of the outer circular edge and the inner circular edge of the first tissue fixing member 3, protruding toward the side away from the nail outlet portion.
  • a reinforcement portion 32 is provided at the outer circumferential edge of the first tissue fixing element 3 .
  • one end side of the first segmentation fracture structure 31 extends to the inner circular edge of the first tissue fixation member 3
  • the other end side of the first segmentation fracture structure 31 extends to the outer circular edge of the first tissue fixation member 3 .
  • the first tissue fixer 3 also includes a reinforcement portion 32 protruding toward the side away from the nail outlet portion, and the end side of the first segmentation fracture structure 31 is connected to the reinforcement portion 32.
  • the reinforcement portion 32 on the first tissue fixer 3 the expansion degree of the anastomosis under the action of tissue tension can be limited, thereby improving the connection strength of the first tissue fixer 3 itself, thereby enhancing the connection strength of the anastomosis, avoiding the risk of anastomotic tearing, and thus improving the success rate of the operation.
  • the first tissue fixing member 3 is fixedly connected to the staple cartridge assembly 1 .
  • first tissue fixing member 3 and the staple cartridge assembly 1 may also be fixedly connected by cold pressing, hot pressing or ultrasonic processes.
  • the first tissue fixer 3 is fixedly connected to the staple magazine assembly 1 by cold pressing technology, which can improve the fixed connection strength between the first tissue fixer 3 and the staple magazine assembly 1, and also improve the connection efficiency between the first tissue fixer 3 and the staple magazine assembly 1.
  • the staple cartridge assembly 1 includes a staple cartridge 11 ; a staple outlet portion is disposed on the staple cartridge 11 ; at least one limiting groove 111 is disposed on the staple outlet portion; and the first tissue fixing member 3 is fixedly connected to the limiting groove 111 .
  • a plurality of limiting grooves 111 may be provided on the nail outlet portion.
  • the number of the limiting grooves 111 may be matched with the number of the first split fracture structures 31 on the first tissue fixation component 3; the positions of the limiting grooves 111 may be matched with the positions of the first split fracture structures 31 on the first tissue fixation component 3.
  • 4 to 16 limiting grooves 111 may be provided on the nail-exiting portion, and the limiting grooves 111 may be evenly spaced along the circumference of the nail-exiting portion.
  • the limiting groove 111 may be located near both end sides of each first segmentation fracture structure 31 .
  • the circumference of the limiting groove 111 is 0.15-110 mm, and preferably, the circumference of the limiting groove 111 is 0.3-20 mm.
  • the adhesion force between the first tissue fixing member 3 and the limiting groove 111 is greater than 0.2N.
  • the adhesion force between the first tissue fixing member 3 and the staple cartridge assembly 1 is greater than 1N and less than or equal to 100N.
  • the method for detecting the adhesion between the first tissue fixing member 3 and the staple cartridge assembly 1 may be a qualitative adhesion detection method or a quantitative adhesion detection method.
  • the qualitative detection method for adhesion can select the YY/T1797-2021 swing test method, and it is required that the first tissue fixing member 3 is fixedly connected to the nail magazine assembly 1 and is not separated, and the first tissue fixing member 3 is not warped.
  • the quantitative detection method of adhesion may be as follows: taking the plane size of the first tissue fixing member 3 as: outer diameter 26mm and inner diameter 17mm, and the plane size of the detection tool as 150*150mm as an example for explanation:
  • the lower surface of the tooling is the working surface, which is smooth. There is a lifting ring on the upper surface of the tooling.
  • the tooling weighs 500g (gravity 4.9N).
  • the upper plane of the first tissue fixing part 3 and the working surface of the detection tooling are bonded with 3M double-sided tape or glue.
  • the nail magazine assembly 1 is fixed with a clamp.
  • the tensile strength meter pulls the tooling lifting ring vertically upward at a speed of 1mm/min until the first tissue fixing part 3 is separated from the limiting groove 111.
  • the value when the first tissue fixing part 3 is separated from the limiting groove 111 is recorded.
  • the value minus the weight of the tooling itself is the adhesion force of the fixed connection between the first tissue fixing part 3 and the limiting groove 111.
  • the adhesion at any fixed connection point is required to be greater than 1N and less than or equal to 100N.
  • At least one limiting groove 111 is provided on the nail outlet portion of the nail magazine 11, and the first tissue fixing member 3 is fixedly connected to the limiting groove 111, thereby improving the stability of the fixed connection between the first tissue fixing member 3 and the nail magazine 11, and increasing the fixed connection strength between the first tissue fixing member 3 and the nail magazine 11, so that the pressing surface of the first tissue fixing member 3 is maintained on the nail magazine 11, thereby avoiding the phenomenon that the first tissue fixing member 3 falls off from the nail magazine 11 due to unreliable connection with the nail magazine 11 before the operation, thereby improving the tissue reinforcement effect of the first tissue fixing member 3 on the anastomotic stoma, thereby reducing bleeding and exudation at the anastomotic stoma, improving the success rate of the operation, and reducing complications.
  • the nail magazine assembly 1 further includes an ejector 12; an ejector assembly groove is provided on the nail magazine 11; and the ejector 12 is installed in the ejector assembly groove.
  • the ejector 12 is provided with a plurality of circumferentially arranged staple ejection blocks 121; the staple accommodating chamber 123 is provided at the ejection end of the staple ejection block 121; and the staple ejection portion is further provided with a plurality of staple ejection openings 112, which correspond one-to-one to the positions of the staple ejection blocks 121.
  • the plurality of staple ejecting blocks 121 are evenly spaced apart along the circumference of the ejector 12 .
  • At least one circle of staple pushing blocks 121 are staggeredly arranged in the circumferential direction of the ejector 12 .
  • two circles of staple pushing blocks 121 are staggeredly arranged in the circumferential direction of the ejector 12 .
  • anvil abutment surface 222 on the anvil body 22 is provided with an anvil groove 2221 that abuts against the staples.
  • the staples abut against the anvil groove 2221, thereby improving the effective deformation degree of the staples and ensuring the suturing quality of the staples.
  • the shapes and sizes of the cross sections of the nail outlet 112 and the limiting groove 111 may be consistent or inconsistent. Preferably, the shapes and sizes of the cross sections of the nail outlet 112 and the limiting groove 111 are consistent.
  • the nail outlet 112 may also be reused as the limiting groove 111 .
  • a plurality of circumferentially arranged staple pushing blocks 121 are provided on the pusher 12
  • a staple accommodating bin 123 is provided at the pushing end of the staple pushing block 121
  • a plurality of staple outlets 112 are further provided on the staple outlet portion
  • the positions of the staple outlets 112 and the staple pushing blocks 121 correspond one to one.
  • a gasket pushing block 122 is further provided on the pusher 12, and the pusher 12 can drive the gasket pushing block 122 to move along the staple pushing direction relative to the staple magazine 11; under the push of the gasket pushing block 122, the first tissue fixing member 3 can be separated from the staple magazine assembly 1.
  • the structure of the limiting groove 111 may be as shown in FIG. 15 , and the structure of the gasket pushing block 122 matches the limiting groove 111 .
  • the gasket push-out block 122 and the staple push-out block 121 may be integrated or separated.
  • the gasket push-out block 122 and the staple push-out block 121 are integrated.
  • the structures of the gasket pushing block 122 and the staple pushing block 121 may be the same or different.
  • the staple pushing block 121 can be reused as the spacer pushing block 122 .
  • the material of the gasket push-out block 122 may be plastic or alloy.
  • the material of the gasket push-out block 122 is plastic.
  • the ejector 12 is provided with a plurality of gasket ejection blocks 122 , and the plurality of gasket ejection blocks 122 are evenly spaced along the circumference of the ejector 12 .
  • the ejector 12 is provided with 4-8 gasket ejection blocks 122 .
  • the surface of the gasket pushing block 122 is smooth or rounded without spikes, so that the gasket pushing block 122 can be smoothly pushed out of the limiting groove 111 .
  • the thrust of the ejector 12 to drive the gasket ejection block 122 to move is required to be no less than 0.1N.
  • the thrust of the gasket ejection block 122 is greater than or equal to 1N.
  • a method for detecting the thrust of the pusher 12 to drive the gasket push-out block 122 to move can be: select the sum of the weights of the vertical pole and the weights on the vertical pole as 100g, vertically insert the vertical pole into the limiting groove 111, and operate the anastomosis device, so that the gasket push-out block 122 can push the vertical pole and the weights on the vertical pole above the surface of the nail magazine 11.
  • the pushing end of the gasket pushing block 122 can be higher than the surface of the nail magazine 11, can be flush with the surface of the nail magazine 11, or can be lower than the surface of the nail magazine 11.
  • the pushing end of the gasket pushing block 122 is higher than the surface of the nail magazine 11.
  • the pusher 12 can drive the gasket pushing block 122 to move relative to the staple magazine 11 along the staple pushing direction.
  • the first tissue fixing member 3 can be smoothly separated from the staple magazine assembly 1, thereby avoiding the first tissue fixing member 3 and the staple magazine assembly 1 from being separated poorly, resulting in the staples tearing and damaging the first tissue fixing member 3, thereby improving the flatness of the first tissue fixing member 3 and the tissue, so that the first tissue fixing member 3 is fixedly connected to the tissue through the staples, thereby improving the reinforcement effect of the first tissue fixing member 3 on the tissue.
  • the gasket pushing block 122 is disposed in the limiting groove 111 .
  • the cross section of the limiting groove 111 is the same size and similar shape as the cross section of the gasket push-out block 122 at the same level.
  • the circumference of the cross section of the limiting groove 111 is slightly smaller than the cross section of the gasket push-out block 122 at the same level and has the same shape.
  • the gasket pushing block 122 in the limiting groove 111, and the structure of the limiting groove 111 is matched with the pushing end of the gasket pushing block 122, it can be ensured that under the push of the gasket pushing block 122, the first tissue fixing member 3 is separated from the nail magazine assembly 1, and at the same time, the flatness of the first tissue fixing member 3 and the tissue and the effectiveness of the connection are not affected due to the excessive pushing stroke of the pushing block 122.
  • the structure of the gasket pushing block 122 can be as shown in Figure 17.
  • the gasket pushing block 122 can shrink axially along the pushing direction.
  • the limiting groove 111 structure cooperating therewith, as shown in Figure 16 the outlet of the limiting groove 111 also shrinks axially along the pushing direction of the gasket pushing block 122.
  • the structure of the limiting groove 111 is matched with the pushing end of the gasket pushing block 122; if the gasket pushing block 122 contracts axially along the pushing direction, during the movement of the gasket pushing block 122 relative to the staple magazine 11 along the pushing direction of the staples, the pushing end of the gasket pushing block 122 is engaged with the limiting groove 111, thereby limiting the pushing distance of the gasket pushing block 122.
  • the structure of the gasket pushing block 122 can also be as shown in Figure 18, where a limiting structure 1221 is provided on the gasket pushing block 122, and a limiting groove 111 structure cooperating therewith is provided, as shown in Figure 19, at the outlet of the limiting groove 111, a limiting protrusion 1111 cooperating with the limiting structure 1221 is provided.
  • FIG. 20 is a schematic diagram of the cooperation between the gasket push-out block 122 and the limiting groove 111, and the limiting structure 1221 is in contact with the limiting protrusion 1111, thereby limiting the push-out stroke of the gasket push-out block 122. While ensuring that the first tissue fixing member 3 is separated from the staple cartridge assembly 1, it is prevented that the push-out stroke of the push-out block 122 is too long to affect the flatness of the first tissue fixing member 3 and the effectiveness of the connection with the tissue.
  • the nail magazine assembly 1 further includes an annular cutting knife 5 , and a cutting knife mounting groove 13 is further provided on the nail magazine 11 , and the annular cutting knife 5 is installed in the cutting knife mounting groove 13 .
  • a cutting knife installation groove 13 is provided on the nail magazine 11, and the annular cutting knife 5 is installed in the cutting knife installation groove 13, which provides an accommodating space for the annular cutting knife 5, thereby improving the stability of the annular cutting knife 5 moving relative to the nail magazine 11.
  • a cutting section 43 is also provided on the second tissue fixing member 4 , and the cutting section 43 is provided on the cutting stroke of the annular cutting knife 5 .
  • the cutting interval 43 can be a row of holes or a solid body.
  • the shape of the row of holes can be circular, elliptical, triangular, polygonal and irregular holes, or part or all of the area can be hollowed out.
  • the cutting interval 43 is a row of holes.
  • the nail anvil assembly 2 also includes an annular anvil 24, and an anvil accommodating groove 223 is provided on the nail anvil body 22.
  • the annular anvil 24 is fixedly connected in the anvil accommodating groove 223.
  • the annular anvil 24 and the annular cutting knife 5 are arranged in corresponding positions. When the nail anvil assembly 2 and the nail magazine assembly 1 are in cooperation, the annular cutting knife 5 can abut against the annular anvil 24.
  • FIGS. 13-14 the structure of the annular anvil 24 is shown in FIGS. 13-14 .
  • a concave cavity structure 241 is provided on the annular anvil 24 .
  • a connecting hole 242 matching the matching hole 221 of the fixing member is provided on the circumference of the annular anvil 24 .
  • connection holes 242 are evenly spaced along the circumference of the annular anvil 24 , and one end of the fixing member 23 passes through the fixing member matching hole 221 and the connection hole 242 in sequence and is fixedly connected to the second tissue reinforcement gasket 4 .
  • the opening end of the concave cavity structure 241 faces the inner wall of the anvil accommodating groove 223, and the connecting end of the concave cavity structure 241 is arranged toward the annular cutting knife 5. It should be noted that the annular anvil 24 is arranged on the cutting path of the annular cutting knife 5.
  • an anvil surface is provided on the side of the connection end of the concave cavity structure 241 facing the annular cutting knife 5 , and the annular cutting knife 5 can abut against the anvil surface.
  • the annular cutting knife 5 when the nail anvil assembly 2 is in cooperation with the nail magazine assembly 1, the annular cutting knife 5 abuts against the anvil surface on the annular anvil 24, so that the target tissue can be cut smoothly, thereby improving the cutting efficiency.
  • the annular cutting knife 5 by providing a concave cavity structure 241 on the annular anvil 24, after the annular cutting knife 5 completes tissue cutting, the annular cutting knife 5 can be prevented from continuing to cut with the entity of the annular anvil 24, thereby affecting the movement efficiency of the annular cutting knife 5 and reducing the cutting force of the annular cutting knife 5.
  • an abutment block 243 is provided on the annular anvil 24 , and the abutment block 243 is disposed in the concave cavity structure 241 . Both ends of the abutment block 243 are respectively fixedly connected to the inner walls on both sides of the concave cavity structure 241 and correspond to the position of the connecting hole 242 .
  • the abutment block 243 is placed above the fixing member 23 on the cutting path of the annular cutting knife 5 .
  • the annular cutting knife 5 abuts against the abutment block 243 on the annular knife anvil 24, thereby cutting off the fixing member 23 and the second tissue reinforcement gasket 4, ensuring that the second tissue reinforcement gasket 4 is smoothly separated from the anvil assembly 2, and then through the provision of the second tissue reinforcement gasket 4, the suturing strength of the suture opening is improved, avoiding the risk of suture opening tearing, thereby improving the success rate of the surgical suture connection opening.
  • the circular tissue suturing device further comprises an operating mechanism, which is in transmission connection with the ejector 12; the operating mechanism can drive the ejector 12 to move, so that the staple ejection block 121 can reciprocate between a preset ejection position and a preset retracted position.
  • the gasket pushing block 122 and the staple pushing block 121 in the pusher 12 can reciprocate between the preset pushing position and the preset retracted position synchronously, or can be pushed out asynchronously.
  • the movement of the gasket pushing block 122 and the staple pushing block 121 may be inconsistent.
  • the gasket pushing block 122 may be pushed out first before the staple pushing block 121 .
  • the annular cutting blade 5 is in transmission connection with the operating mechanism; the operating mechanism can drive the annular cutting blade 5 to reciprocate in the cutting direction.
  • the annular cutting knife 5 is driven to move in the cutting direction by the operating mechanism, and then the annular cutting knife 5 contacts the tissue and abuts on the anvil surface of the annular anvil 24, thereby cutting off the target tissue.
  • the annular cutting knife 5 further moves in the cutting direction, the annular cutting knife 5 contacts the fixing piece 23 and abuts on the abutment block 243 of the annular anvil 24, thereby cutting off the fixing piece 23, so that the second tissue fixing piece 4 is separated from the anvil body 22.
  • the operating mechanism can be transmission-connected to the anvil assembly 2; the operating mechanism can drive the anvil assembly 2 to move axially relative to the nail magazine assembly 1 until the anvil assembly 2 and the nail magazine assembly 1 reach a matching state; the operating mechanism can drive the anvil assembly 2 to move axially in coordination with the nail magazine assembly 1.
  • a connecting rod 21 is further provided on the anvil assembly 2; one end of the connecting rod 21 is fixed to the bottom of the annular inner cavity, and the other end of the connecting rod 21 is used for transmission connection with the operating mechanism.
  • the connecting rod 21 is disposed on the axis of the anvil body 22 .
  • the connecting rod 21 is transmission-connected to the operating mechanism.
  • the anvil assembly 2 can move along the nail magazine assembly 1, thereby ensuring the connection stability between the anvil assembly 2 and the operating mechanism.
  • the present application ensures the reliability of the connection between the first tissue fixing member 3 and the staple cartridge assembly 1 before the operation by detachably connecting the first tissue fixing member 3 and the staple cartridge assembly 1.
  • the staples can fix the first tissue fixing member 3 on the tissue, thereby improving the connection strength of the anastomosis.
  • the first tissue fixing member 3 is used to fill the gap between the staples and the tissue, thereby reducing the phenomenon of anastomotic bleeding, exudation and anastomotic tearing, thereby reducing the occurrence of postoperative complications, thereby improving the success rate of the operation.
  • the present application avoids the risk of the second tissue fixer 4 being detached from the anvil assembly 2 before surgery by fixedly connecting the second tissue fixer 4 to the anvil assembly 2.
  • the second tissue fixer 4 is arranged at the end side of the anvil assembly 2, and the second tissue fixer 4 is arranged toward the first tissue fixer 3.
  • the staples can fix the first tissue fixer 3 and the second tissue fixer 4 to the tissue at the anastomosis, thereby improving the connection strength of the anastomosis, thereby reducing the phenomenon of anastomotic tearing.
  • the first tissue fixer 3 and the second tissue fixer 4 are used to fill the gap between the staples and the tissue, thereby avoiding the risk of bleeding and exudation at the anastomosis, reducing complications, and thus reducing surgical risks.
  • At least one first split fracture structure 31 is provided on the first tissue fixing member 3
  • at least one second split fracture structure 41 is provided on the second tissue fixing member 4.
  • the anastomosis can have a certain amount of expansion under the action of tissue tension on the basis of reinforcing the tissue, thereby facilitating the removal of the anvil assembly 2 from the anastomosis, thereby avoiding the risk of anastomotic tearing during the removal of the anvil assembly 2, thereby improving the success rate of the operation.
  • the first segmentation fracture structure 31 and the second segmentation fracture structure 41 are configured to have the same structure, and when the nail anvil assembly 2 and the nail magazine assembly 1 are connected in an aligned manner, the first segmentation fracture structure The position of 31 is relative to the position of the second split fracture structure 41, which can ensure that under the action of tissue tension, the first tissue fixer 3 and the second tissue fixer 4 are separated from the corresponding first split fracture structure 31 and the second split fracture structure 41 in a consistent size and direction, thereby ensuring the consistency of the separation amount at the first split fracture structure 31 and the second split fracture structure 41, avoiding the risk of anastomotic tearing due to misaligned separation of the first tissue fixer 3 and the second tissue fixer 4, thereby improving the success rate of the operation.
  • the first tissue fixer 3 also includes a reinforcement portion 32 protruding toward the side away from the nail outlet portion, and the end side of the first segmentation fracture structure 31 is connected to the reinforcement portion 32.
  • the reinforcement portion 32 on the first tissue fixer 3 can limit the expansion degree of the anastomosis under the action of tissue tension, thereby improving the connection strength of the first tissue fixer 3 itself, thereby enhancing the connection strength of the anastomosis, avoiding the risk of anastomotic tearing, and thus improving the success rate of the operation.
  • At least one limiting groove 111 is provided on the nail outlet portion of the nail magazine 11, and the first tissue fixing member 3 is fixedly connected to the limiting groove 111, thereby improving the stability of the fixed connection between the first tissue fixing member 3 and the nail magazine 11, and preventing the first tissue fixing member 3 from being unreliably connected to the nail magazine 11 before the operation and falling off the nail magazine 11, thereby improving the tissue reinforcement effect of the first tissue fixing member 3 on the anastomotic stoma, thereby reducing bleeding and exudation at the anastomotic stoma, improving the success rate of the operation, and reducing complications.
  • a plurality of circumferentially arranged staple pushing blocks 121 are provided on the pusher 12
  • a staple accommodating bin 123 is provided at the pushing end of the staple pushing block 121
  • a plurality of staple outlets 112 are further provided on the staple outlet portion
  • the positions of the staple outlets 112 correspond one to one with the positions of the staple pushing blocks 121.
  • a gasket push-out block 122 is further provided on the push-out device 12, and the push-out device 12 can drive the gasket push-out block 122 to move relative to the staple cartridge 11 in the staple push-out direction.
  • the first tissue fixing member 3 can be smoothly separated from the staple cartridge assembly 1, thereby avoiding the first tissue fixing member 3 being torn and damaged by the staples due to poor separation from the staple cartridge assembly 1.
  • the first tissue fixing member 3 is fixedly connected to the tissue by the staples, thereby improving the flatness of the first tissue fixing member 3 and the tissue, thereby improving the reinforcement effect of the first tissue fixing member 3 on the tissue.
  • the circular tissue suturing device includes a staple magazine assembly 1, a staple anvil assembly 2 used in conjunction with the staple magazine assembly 1, and a first tissue fixing component 3; the first tissue fixing component 3 is detachably connected to the staple magazine assembly 1; the staple magazine assembly 1 is provided with a staple magazine 11, and the staple magazine 11 is provided with a plurality of staple accommodating bins 123 matching with staples, and the first tissue fixing component 3 is arranged on the end side of the staple outlet portion; when the staple anvil assembly 2 is in a state of being matched with the staple magazine assembly 1, the first tissue fixing component 3 is placed between the staple anvil assembly 2 and the staple magazine assembly 1, and the staples are fixedly connected to the first tissue fixing component 3.
  • the circular tissue suturing device further includes a second tissue fixing member 4.
  • the first tissue fixing member 3 and the second tissue fixing member 4 are made of the same material, namely poly(lactide-glycolide) (PLGA).
  • the first tissue fixer 3 is a concentric circle structure, and a reinforcement part 32 is provided at the outer circle edge of the concentric circle protruding toward the side away from the nail outlet part.
  • Four straight-line first split fracture structures 31 are provided on the first tissue fixer 3, and the first split fracture structures 31 penetrate the outer circle and inner circle of the gasket first tissue fixer 3.
  • the second tissue fixing member 4 includes a semicircular connecting portion 43 and a gasket body 42.
  • the gasket body 42 is provided with four straight second segmentation fracture structures 41.
  • the second segmentation fracture structures 41 penetrate the outer ring of the gasket second tissue fixing member 4 and the inner ring of the second tissue fixing member 4.
  • Four connecting portions 43 are evenly distributed on the inner ring edge and the outer ring edge of the gasket body 42, facing away from the first tissue fixing member 3.
  • the connecting portions 43 are provided at the second segmentation fracture structures 41 of the second tissue fixing member 4, and the connecting portions 43 connect the entity parts on both sides of the second tissue fixing member 4.
  • the anvil assembly 2 includes an anvil body 22 and four fixing members 23 .
  • the side wall of the anvil body 22 is provided with fixing member matching holes 221 at equal intervals.
  • One end of the fixing member 23 can pass through the fixing member matching hole 221 , and the other end of the fixing member 23 is arranged outside the anvil body 22 .
  • the nail anvil assembly 2 also includes an annular knife anvil 24, as shown in Figures 12-14, the annular knife anvil 24 is provided with a concave cavity structure 241, and the annular knife anvil 24 is provided with connecting holes 242 matching the matching holes 221 of the fixing member on the circumference, and the connecting holes 242 are evenly spaced along the circumference of the annular knife anvil 24.
  • the connecting block 243 is arranged in the concave cavity structure 241, and the two ends of the abutting block 243 are respectively fixedly connected to the inner walls on both sides of the concave cavity structure 241, and correspond to the position of the connecting hole 242. After the fixing member 23 passes through the connecting hole 242, the abutting block 243 is placed above the fixing member 23 on the cutting path of the annular cutting knife 5.
  • An anvil receiving groove 223 is provided on the anvil body 22, and the annular anvil 24 is fixedly connected in the anvil receiving groove 223.
  • the opening end of the concave cavity structure 241 faces the inner wall of the anvil receiving groove 223, and the connecting end of the concave cavity structure 241 is arranged toward the annular cutting knife 5.
  • One end of the fixing member 23 passes through the fixing member matching hole 221 and the connecting hole 242 in sequence, and is hot-pressed and fixedly connected to the connecting portion 43 on the inner edge of the second tissue fixing member 4, and the other end of the fixing member 23 is hot-pressed and fixedly connected to the connecting portion 43 on the outer edge of the second tissue fixing member 4.
  • the staple cartridge assembly 1 includes an ejector 12; an ejector assembly groove is provided on the staple cartridge 11; the ejector 12 is installed in the ejector assembly groove, and two circles of staple ejection blocks 121 are alternately arranged in the circumferential direction of the ejector 12, and a plurality of staple outlets 112 are also provided on the staple outlet portion, and the positions of the staple outlets 112 and the staple ejection blocks 121 correspond one to one, and a staple accommodating bin 123 is provided at the ejection end of the staple ejection block 121.
  • the nail magazine assembly 1 includes a nail magazine 11, which is provided with sixteen limiting grooves 111; the first tissue fixing piece 3 is cold-pressed and fixedly connected to the limiting grooves 111, and when the first tissue fixing piece 3 is cold-pressed and fixedly connected to the limiting grooves 111, the positions of the limiting grooves 111 are distributed near the two end sides of the first split fracture structure 31.
  • the ejector 12 is further provided with a gasket ejection block 122 , and the setting position of the gasket ejection block 122 is corresponding to the position of the limiting groove 111 .
  • a limiting structure 1221 is provided on the end of the gasket pushing block 122 opposite to the pushing end, and correspondingly, a limiting protrusion 1111 cooperating with the limiting structure 1221 is provided on the limiting groove 111, and then the pushing stroke of the gasket pushing block 122 is limited by the limiting abutment between the limiting structure 1221 and the limiting protrusion 1111.
  • the nail magazine assembly 1 further includes an annular cutting knife 5 .
  • a cutting knife installation groove 13 is further provided on the nail magazine 11 .
  • the annular cutting knife 5 is installed in the cutting knife installation groove 13 .
  • the circular tissue suturing device also includes an operating mechanism, which can be respectively connected to the ejector 12, the anvil assembly 2 and the annular cutting knife 5. Driven by the operating mechanism, the ejector 12 can simultaneously drive the staple ejection block 121 and the gasket ejection block 122 to reciprocate along the staple outlet 112 and the limiting groove 111 respectively.
  • an operating mechanism which can be respectively connected to the ejector 12, the anvil assembly 2 and the annular cutting knife 5.
  • the ejector 12 can simultaneously drive the staple ejection block 121 and the gasket ejection block 122 to reciprocate along the staple outlet 112 and the limiting groove 111 respectively.
  • the annular cutting knife 5 can reciprocate in the cutting direction, and then the annular cutting knife 5 contacts the tissue and abuts on the anvil surface of the annular anvil 24 to cut off the target tissue.
  • the annular cutting knife 5 further moves along the cutting direction, the annular cutting knife 5 contacts the fixing member 23 and abuts on the abutment block 243 of the annular anvil 24, thereby cutting off the fixing member 23, so that the second tissue fixing member 4 is separated from the nail anvil body 22.
  • the operating mechanism can also drive the anvil assembly 2 to move axially relative to the staple cartridge assembly 1 , so that the anvil assembly 2 and the staple cartridge assembly 1 reach a matching state.
  • the difference between the second embodiment and the first embodiment lies in the structure of the gasket push-out block 122 and the structure of the limiting groove 111, and the setting of the matching mode between the gasket push-out block 122 and the limiting groove 111.
  • the similarities with the first embodiment are not repeated here.
  • the differences between the second embodiment and the first embodiment are described as follows:
  • the gasket pushing-out block 122 contracts axially along the pushing-out direction, and the structure of the limiting groove 111 is matched with the pushing-out end of the gasket pushing-out block 122.
  • the pushing-out end of the gasket pushing-out block 122 is engaged with the inner wall of the limiting groove 111, thereby limiting the pushing-out distance of the gasket pushing-out block 122.
  • the difference between the third embodiment and the first embodiment lies in the structures of the first tissue fixing member 3 and the second tissue fixing member 4.
  • the similarities with the first embodiment are not repeated here.
  • the differences between the third embodiment and the first embodiment are described as follows:
  • the structure of the first tissue fixing member 3 is shown in FIG. 7 .
  • the first tissue fixing member 3 is not provided with a first segmentation fracture structure
  • the second tissue fixing member 4 is not provided with a second segmentation fracture structure.
  • the structures of the first tissue fixing member 3 and the second tissue fixing member 4 can be simplified. It is convenient to assemble the first tissue fixer 3 and the second tissue fixer 4 with the corresponding anvil assembly 2 and the staple cartridge assembly 1, thereby achieving the first tissue fixer 3 and the second tissue fixer 4 being fixedly connected to the tissue by staples, thereby improving the connection strength of the anastomosis.
  • the structure of the first tissue fixing member 3 is shown in FIG. 3 , and the first tissue fixing member 3 is not provided with a reinforcing portion 32 .
  • the structure of the first tissue fixer 3 can be simplified, and the assembly of the first tissue fixer 3 and the corresponding anvil assembly 2 is facilitated, thereby achieving the first tissue fixer 3 being fixedly connected to the tissue by means of staples, thereby improving the connection strength of the anastomosis.
  • the first tissue fixing piece 3 is fixedly connected in the limiting groove 111 by cold pressing, and then one end of the fixing piece 23 is passed through the fixing piece matching hole 221 and the connecting hole 242 in sequence, and then is hot-pressed and fixedly connected to the connecting part 43 on the inner edge of the second tissue fixing piece 4, and the other end of the fixing piece 23 is hot-pressed and fixedly connected to the connecting part 43 on the outer edge of the second tissue fixing piece 4.
  • the connecting rod 21 on the anvil assembly 2 is connected to the operating mechanism through transmission, and then, driven by the operating mechanism, the anvil assembly 2 moves axially relative to the staple cartridge assembly 1 until the anvil assembly 2 and the staple cartridge assembly 1 reach a stapled state.
  • the ejector 12 is driven to move by the operating mechanism, so that the staple ejection block 121 and the gasket ejection block 122 are simultaneously pushed to a preset ejection position along the ejection direction of the ejector 12, and then, under the action of the gasket ejection block 122, the first tissue fixing member 3 is disengaged from the limiting groove 111, and at the same time, the staples in the staple ejection block 121 sequentially contact the first tissue fixing member 3, the tissue and the second tissue fixing member 4, and then abut against the anvil abutting surface 222 on the anvil body 22, so that the suturing quality of the anastomosis is ensured through the effective deformation degree of the staples.
  • the annular cutting knife 5 of the operating mechanism moves along the cutting direction, and then After the annular cutting knife 5 contacts the tissue, it abuts against the anvil surface of the annular anvil 24, thereby cutting off the target tissue.
  • the annular cutting knife 5 further moves along the cutting direction. After the annular cutting knife 5 contacts the fixing member 23, it abuts against the abutment block 243 of the annular anvil 24, thereby cutting off the fixing member 23, so that the second tissue fixing member 4 is separated from the nail anvil body 22.
  • anvil body 22 is taken out from the suture opening by rotating it left and right.

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Abstract

La présente demande concerne le domaine technique des dispositifs médicaux et, en particulier un dispositif d'agrafage de tissu circulaire, comprenant un ensemble cartouche, un ensemble enclume, un premier fixateur de tissu et un second fixateur de tissu, le premier fixateur de tissu étant relié de manière amovible à l'ensemble cartouche ; le second fixateur de tissu étant relié de manière fixe à l'ensemble enclume ; l'ensemble cartouche étant pourvu d'une cartouche et le premier fixateur de tissu étant disposé sur un côté d'extrémité de la cartouche ; et, lorsque l'ensemble enclume est ajusté avec l'ensemble cartouche, le premier fixateur de tissu et le second fixateur de tissu étant situés entre l'ensemble enclume et l'ensemble cartouche. Dans la présente demande, le premier fixateur de tissu est relié de manière amovible à l'ensemble cartouche, ce qui assure la fiabilité de connexion entre le premier fixateur de tissu et l'ensemble cartouche avant la chirurgie ; et, lorsque l'ensemble enclume est ajusté avec l'ensemble cartouche, une agrafe passe séquentiellement à travers et est fixée au premier et au second fixateur de tissu, ce qui améliore la force de connexion d'une anastomose, réduisant ainsi le risque chirurgical de déchirement de l'anastomose.
PCT/CN2023/085580 2023-03-24 2023-03-31 Dispositif d'agrafage de tissu circulaire Ceased WO2024197849A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202310301648.1 2023-03-24
CN202310301648.1A CN116138830A (zh) 2023-03-24 2023-03-24 一种圆形组织缝合装置

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Publication Number Publication Date
WO2024197849A1 true WO2024197849A1 (fr) 2024-10-03

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WO (1) WO2024197849A1 (fr)

Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN121370274A (zh) * 2025-11-13 2026-01-23 中国人民解放军总医院第一医学中心 一种胃肠外科手术管型肠道吻合器

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116421247A (zh) * 2023-03-24 2023-07-14 苏州卡夫思曼医疗科技有限公司 一种医用吻合连接装置

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