WO2024197877A1 - Dispositif de connexion anastomotique médical - Google Patents
Dispositif de connexion anastomotique médical Download PDFInfo
- Publication number
- WO2024197877A1 WO2024197877A1 PCT/CN2023/085646 CN2023085646W WO2024197877A1 WO 2024197877 A1 WO2024197877 A1 WO 2024197877A1 CN 2023085646 W CN2023085646 W CN 2023085646W WO 2024197877 A1 WO2024197877 A1 WO 2024197877A1
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- WO
- WIPO (PCT)
- Prior art keywords
- anvil
- annular
- reinforcement
- connection
- tissue
- 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
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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
- A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
- A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
-
- 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 medical anastomotic connection device.
- circular staplers are widely used in surgical operations on organs such as the stomach, intestines, and esophagus.
- the circular stapler commonly used in the prior art includes two parts: a stapler end and a stapler outlet end.
- the stapler outlet end is installed with a stapler for suturing.
- the stapler and the stapler end are abutted against each other, thereby achieving tissue suturing.
- the tightness between the stapler end and the stapler outlet end is poor.
- the tissue can be sutured, the gap between the two will reduce the intraoperative support strength of the tissue at the anastomosis site, and secondary damage is easily caused when the anastomotic device is removed, thereby causing postoperative complications and the risk of massive bleeding.
- the present application provides an improved medical anastomotic connection device.
- the present application provides a medical anastomosis connection device, including a nail anvil, a nail storage device and a reinforcement member; the nail anvil and the nail storage device are used in combination, and at least one connecting through hole is arranged on the side wall of the nail anvil, the nail anvil is provided with a nail anvil surface, and one side of the reinforcement member is provided with a tissue contact surface and an abutment surface opposite to the tissue contact surface; the connecting through hole passes through the nail anvil, and the reinforcement member is connected to the nail anvil through the connecting through hole, and after the reinforcement member is connected to the nail anvil, the relative position of the reinforcement member and the nail anvil is fixed; the abutment surface of the reinforcement member is in contact with the nail anvil surface.
- the reinforcement member includes a first connecting position and a second connecting position, and at least one of the first connecting position and the second connecting position is provided with at least one connecting structure protruding away from the nail storage device; the connecting structure passes through the connecting through hole and is fixedly connected to the reinforcement member; the abutting surface of the reinforcement member is in contact with the nail abutting surface.
- the medical anastomosis connection device also includes a plurality of the connection structures, a plurality of connection through holes are provided on the side wall of the anvil seat, and the plurality of connection structures correspond one-to-one to the plurality of connection through holes.
- the medical anastomosis connection device also includes at least one connecting member; the connecting member has a first end and a second end connected, and at least one of the first end and the second end is arranged on the outer side of the dowel seat after passing through the connecting through hole and fixedly connected to the reinforcement member.
- it also includes a plurality of connecting members; a plurality of connecting through holes are arranged on the side wall of the dowel seat, and the plurality of connecting members correspond one-to-one to the plurality of connecting through holes.
- the reinforcement member includes an annular gasket, on which at least one detachable connecting belt is provided, and the detachable connecting belt extends from an inner edge of the annular gasket to an outer edge of the annular gasket.
- it also includes an annular member, and an annular member mounting groove is provided on the nail support; the annular member is fixedly connected in the annular member mounting groove, and the annular member is arranged on the cutting stroke of the tissue cutting knife.
- the annular member includes an inner ring member, a connecting arm and an outer ring member; the inner ring member and one end of the outer ring member are fixedly connected by the connecting arm; an annular groove is formed between the inner ring member and the outer ring member, and one side of the opening of the annular groove abuts against the inner wall of the annular member mounting groove.
- the nail storage device includes a tissue cutting knife, which can move along the cutting direction toward the nail support; the connecting arm is provided with a circular cutting abutment surface, which is arranged toward the tissue cutting knife, and the circular cutting abutment surface is arranged on the cutting stroke of the tissue cutting knife.
- the annular member is provided with an avoidance hole matching the connecting through hole; the avoidance hole passes through the inner ring member and the outer ring member; and the first end of the connecting member can pass through the connecting through hole and the avoidance hole in sequence.
- the connecting member passes through the annular groove, and a cross bar is also provided on the annular member; the cross bar is arranged in the annular groove, one end of the cross bar is fixedly connected to the inner ring member, and the other end of the cross bar is fixedly connected to the outer ring member; in the cutting direction, the cross bar is placed above the connecting member.
- annular abutting surface is provided on the abutting surface of the annular abutting surface, and a staple abutting groove is provided on the annular abutting surface; when the annular abutting surface and the staple storage device are in cooperation, the staple pushed out from the staple storage device abuts against the staple abutting groove.
- the reinforcement meets at least one of the following characteristics: the thickness of the reinforcement is 0.01-1.5 mm; the surface smoothness of the reinforcement is 0.1-60S; the bending stiffness of the reinforcement is 0.01-6mN*m; and the air permeability of the reinforcement is 0.1-200 ⁇ m/(Pa ⁇ s).
- the connecting piece satisfies at least one of the following characteristics: the thickness of the connecting piece is 0.01-1.5 mm; the width of the connecting piece is 0.02-110 mm.
- the connecting through hole of the present application passes through the anvil seat.
- the reinforcement is connected to the anvil seat through the connecting through hole and the relative positions of the reinforcement and the anvil seat are fixed, so that the abutment surface of the reinforcement fits with the anvil surface, avoiding the risk of the reinforcement detaching from the anvil seat before surgery and ensuring the flatness of the abutment surface of the reinforcement and the anvil surface, thereby improving the connection strength of the suture connection.
- At least one of the first connecting position and the second connecting position on the reinforcement is provided with at least one connecting structure protruding toward and away from the nail storage device; the connecting structure passes through the connecting through hole and is fixedly connected to the reinforcement; thereby, the abutting surface of the reinforcement is fitted with the abutting surface, thereby improving the stability of the connection between the reinforcement and the abutting seat, thereby improving the flatness of the abutting surface of the reinforcement and the abutting surface of the abutting seat.
- the present application provides a connecting through hole on the side wall of the anvil seat, and a connecting piece passes through the connecting through hole and is fixedly connected to the reinforcement piece, thereby avoiding the phenomenon of the reinforcement piece falling off the anvil seat due to unreliable connection between the reinforcement piece and the anvil seat before surgery, thereby improving the reliability of the fixed connection between the reinforcement piece and the anvil seat, and ensuring the flatness of the abutment surface of the reinforcement piece and the anvil surface, thereby making the puncture port of the staple neat and flat, and filling the gap between the staple and the tissue with the reinforcement piece, thereby reducing the slippage of the tissue during surgical suturing and improving the effect of reinforcing the tissue.
- multiple connecting pieces are added, and multiple connecting through holes are set on the side wall of the anvil seat.
- the multiple connecting pieces correspond to the multiple connecting through holes one by one, and multiple connecting belts are sequentially passed through the corresponding connecting through holes and then fixedly connected with the reinforcing piece, thereby improving the connection strength of the fixed connection between the reinforcing piece and the anvil surface of the anvil seat.
- the degree of flatness of the abutment surface of the reinforcement and the abutment surface is improved, thereby improving the success rate of the surgical suture connection.
- At least one detachable connecting band is provided on the annular gasket of the reinforcement member, and the detachable connecting band extends from the outer edge of the annular gasket to the inner edge of the annular gasket.
- annular member is added, fixedly connected to the annular member mounting groove of the annular member support, and the annular member is arranged on the cutting stroke of the tissue cutting knife.
- the annular member limits the movement stroke of the tissue cutting knife, thereby providing the tissue cutting knife with an abutment surface for cutting tissue, making it easier for the tissue cutting knife to cut tissue, thereby improving the cutting effect and cutting efficiency of the cutting knife, thereby ensuring the integrity of the tissue incision.
- the annular member includes an inner ring member, a connecting arm and an outer ring member, and one end of the inner ring member and the outer ring member are fixedly connected by the connecting arm, and an annular groove is formed between the inner ring member and the outer ring member, and one side of the opening of the annular groove abuts on the inner wall of the annular member mounting groove, and the annular groove is arranged on the cutting stroke of the tissue cutting knife.
- the connecting arm provides an abutment surface for the tissue cutting knife, which facilitates the tissue cutting knife to cut the tissue; after the tissue cutting knife completes tissue cutting by abutting with the connecting arm, the tissue cutting knife can move into the annular groove, thereby reducing the cutting force of the tissue cutting knife, thereby improving the movement efficiency of the tissue cutting knife, and by abutting the tissue cutting knife with the inner wall of the annular member mounting groove, the movement end point of the tissue cutting knife is limited, thereby providing the operator with a prompt that the tissue cutting knife has moved into place.
- a cross bar is also provided on the annular member, and the cross bar is provided in the annular groove.
- the connecting member passes through the annular groove.
- One end of the cross bar is fixedly connected to the inner ring member, and the other end of the cross bar is fixedly connected to the outer ring member.
- the cross bar is placed above the connecting member, and the cross bar provides an abutment effect for the tissue cutting knife to cut the connecting member, which facilitates the tissue cutting knife to cut off the connecting member, thereby separating the reinforcement member from the nailing surface.
- a staple abutment groove is provided on the staple abutment surface of the staple anvil.
- the staple abutment groove abuts against the staple, thereby improving the effective deformation of the staple. degree, thereby ensuring the suturing quality of the anastomotic staples, thereby improving the suturing strength of the sutured opening, avoiding the risk of sutured opening tearing, and thus improving the success rate of the surgical sutured connection opening.
- FIG1 is a schematic diagram of the overall structure of a medical anastomotic connection device provided in an embodiment of the present application
- FIG2 is a schematic diagram of the overall structure of the assembly of the anvil and the reinforcement member provided in an embodiment of the present application;
- FIG3 is an exploded view of the overall structure of the assembly of the anvil and the reinforcement member provided in an embodiment of the present application;
- FIG4 is a schematic diagram of the structure of an anvil provided in an embodiment of the present application.
- FIG5 is a schematic diagram of the structure of a reinforcement member provided in an embodiment of the present application.
- FIG6 is a schematic diagram of a structure in which a detachable connecting belt is provided on a reinforcement member provided in an embodiment of the present application;
- FIG7 is a schematic structural diagram of another reinforcement member provided in an embodiment of the present application, in which a detachable connecting belt is provided;
- FIG8 is a cross-sectional view of a ring member provided in an embodiment of the present application.
- FIG. 9 is a schematic diagram of the structure of a connector provided in an embodiment of the present application.
- a circular tissue anastomosis connection device provided in an embodiment of the present application includes a nail anvil 1, a nail storage device 2 and a reinforcement member 3; the nail anvil 1 and the nail storage device 2 are used in conjunction with each other, and at least one connecting through hole 11 is provided on the side wall of the nail anvil 1, the nail anvil 1 is provided with a nail anvil surface, and one side of the reinforcement member 3 is provided with a tissue contact surface and an abutment surface opposite to the tissue contact surface; the connecting through hole 11 passes through the nail anvil 1, and the reinforcement member 3 is connected to the nail anvil 1 through the connecting through hole 11. After the reinforcement member 3 is connected to the nail anvil 1, the relative position of the reinforcement member 3 and the nail anvil 1 is fixed, and the abutment surface of the reinforcement member 3 is in contact with the nail anvil surface.
- the present application sets a connecting through hole 11 on the side wall of the anvil seat 1, and the connecting through hole 11 passes through the anvil seat 1, and the reinforcement 3 is connected to the anvil seat 1 through the connecting through hole 11, and the relative positions of the reinforcement 3 and the anvil seat 1 are fixed, so that the abutting surface of the reinforcement 3 is in contact with the anvil surface, and the flatness of the abutting surface of the reinforcement 3 and the anvil surface is ensured, so that the puncture port of the staple is neat and flat, and the gap between the staple and the tissue is filled by the reinforcement 3, so as to reduce the slippage of the tissue during the surgical suturing process and improve the effect of reinforcing the tissue, thereby reducing the bleeding and exudation of the suture connection port, improving the success rate of the suturing operation, and reducing complications.
- the cross-sectional structure of the connecting through hole 11 may be triangular, quadrilateral or polygonal, or circular, elliptical or irregular.
- the circumference of the connecting through hole 11 is 0.05-100 mm.
- the circumference of the connecting through hole 11 is 1-20 mm.
- the extension line of the connecting through hole 11 can reach the axis of the anvil seat 1, and can also be at a certain distance from the axis of the anvil seat 1.
- the extension line of the connecting through hole 11 reaches the axis of the dowel seat 1.
- the preferred material of the reinforcement 3 is poly(lactide-glycolide) (PLGA) or poly(glycolide) (PGA).
- the reinforcement 3 includes a first connection position and a second connection position, and at least one of the first connection position and the second connection position is provided with at least one connection structure 32 protruding away from the nail storage device 2; the connection structure 32 passes through the connecting hole 11 and is fixedly connected to the reinforcement 3; the abutting surface of the reinforcement 3 is in contact with the nail abutting surface.
- connection structure 32 and the reinforcement member 3 may also be integrally connected by using processes such as heat pressing, sewing, gluing or ultrasound.
- the bonding force of each connection and fixing point needs to be greater than 0.1N.
- the bonding force is greater than or equal to 0.5N.
- first connection position and the second connection position can be respectively arranged at the inner edge and the outer edge of the reinforcement 3, and the connection structure 32 of the first connection position and the second connection position can be a convex structure, which can be semicircular, semi-elliptical, triangular, polygonal or irregular.
- a first connection position and a second connection position are respectively provided on the inner edge and the outer edge of the reinforcement 3, and a protrusion structure is provided on at least one of the first connection position and the second connection position, and the protrusion structure passes through the connecting through hole 11 and is fixedly connected to the reinforcement 3; thereby, the abutting surface of the reinforcement 3 is fitted with the abutting surface, thereby improving the connection strength between the reinforcement 3 and the abutting seat 1.
- a connection structure 32 is provided on either the first connection position or the second connection position, and the connection structure 32 on the first connection position is passed through the connection through hole 11 and then fixedly connected to the reinforcement member 3 .
- connection structure 32 is provided on the first connection position, and no connection structure 32 is provided on the second connection position, and the connection structure 32 on the first connection position passes through the connection through hole 11 and is fixedly connected to the reinforcement member 3 .
- a connecting structure 32 is provided on both the first connecting position and the second connecting position, and the connecting structure 32 on the first connecting position is arranged corresponding to the connecting structure 32 on the second connecting position, and the length of the connecting structure 32 on the first connecting position is greater than the length of the connecting structure 32 on the second connecting position.
- the connecting structure 32 on the first connecting position is passed through the connecting through hole and fixedly connected with the connecting structure 32 provided on the second connecting position, thereby improving the fixed connection strength and connection efficiency of the reinforcement 3 and the nail seat 1.
- connection structure 32 is disposed on the first connection position, and at least one connection structure 32 is disposed on the second connection position.
- multiple protrusion structures are arranged at equal intervals on the first connection position of the reinforcement member 3, and multiple protrusion structures are also arranged on the second connection position of the reinforcement member 3, and the positions of the protrusion structures on the first connection position and the protrusion structures on the second connection position are arranged one by one.
- a connecting structure 32 is provided on the reinforcement 3 so as to protrude toward the side away from the nail storage device 2, and the connecting structure 32 is passed through the connecting through hole 11 and fixedly connected to the reinforcement 3, thereby connecting the reinforcement 3 to the nail-avoiding surface of the nail-avoiding seat 1, thereby improving the connection strength of the fixed connection between the reinforcement 3 and the nail-avoiding seat 1 and ensuring the flatness of the abutting surface of the reinforcement 3 and the nail-avoiding surface.
- a plurality of connection structures 32 are further included, and a plurality of connection through holes 11 are provided on the side wall of the dowel seat 1 , and the plurality of connection structures 32 correspond one-to-one to the plurality of connection through holes 11 .
- a plurality of connecting through holes 11 are evenly distributed along the circumference of the side wall of the dowel seat 1 .
- connecting through holes 11 are arranged at equal intervals along the circumferential direction of the side wall of the dowel seat 1.
- a plurality of connecting structures 32 and a plurality of connecting through holes 11 are provided, and the connecting structures 32 are provided corresponding to the positions of the connecting through holes 11.
- the plurality of connecting structures 32 sequentially penetrate the corresponding connecting through holes 11 and are fixedly connected to the reinforcement member 3, thereby improving the stability of the connection between the reinforcement member 3 and the dowel seat 1.
- the medical anastomosis connection device also includes at least one connecting member 4; the connecting member 4 has a first end and a second end connected, and at least one of the first end and the second end passes through the connecting through hole 11 and is arranged on the outside of the nail seat 1 and fixedly connected to the reinforcement member 3.
- the material of the connector 4 can be a biological material, such as the pericardial matrix, dermal matrix or small intestinal submucosal matrix except for antigens, or a synthetic material, such as polylactide (PLA), polyglycolide (PLGA), polyglycolide (PGA), polycaprolactone (PCL) or para-dioxanone (PDO).
- a biological material such as the pericardial matrix, dermal matrix or small intestinal submucosal matrix except for antigens
- synthetic material such as polylactide (PLA), polyglycolide (PLGA), polyglycolide (PGA), polycaprolactone (PCL) or para-dioxanone (PDO).
- PLA polylactide
- PLGA polyglycolide
- PGA polyglycolide
- PCL polycaprolactone
- PDO para-dioxanone
- the reinforcing member 3 and the connecting member 4 are made of the same material, which is poly(lactide-glycolide) (PLGA).
- PLGA poly(lactide-glycolide)
- the specific structure of the connecting member 4 is shown in FIG. 9 , and the first end and the second end of the connecting member 4 are both protruded toward one side of the reinforcing member 3 , so as to facilitate fixed connection with the reinforcing member 3 through the first end and the second end.
- the fixed connection between the connecting member 4 and the reinforcing member 3 can also be integrated by processes such as hot pressing, sewing, gluing or ultrasound.
- the connecting member 4 and the reinforcing member 3 are connected by a hot pressing process, so that the bonding force of the hot pressing bonding point meets the use requirements, and the hot pressing bonding parts of the connecting member 4 and the reinforcing member 3 are completely combined together, thereby improving the connection strength between the connecting member 4 and the reinforcing member 3.
- the bonding force of each connection and fixing point needs to be greater than 0.1N.
- the bonding force is greater than or equal to 0.5N.
- the magnitude of the fixed connection bonding force between the connecting member 4 and the reinforcing member 3 is determined by means of a qualitative bonding force detection experiment and a quantitative bonding force detection experiment.
- the medical anastomosis connection device further includes a plurality of connection members 4 ; a plurality of connection through holes 11 are provided on the side wall of the anvil 1 , and the plurality of connection members 4 correspond to the plurality of connection through holes 11 one by one.
- a plurality of connecting through holes 11 may be distributed at equal intervals in the circumferential direction of the side wall of the anvil seat 1 .
- the structure of the connecting through hole 11 matches the structure of the connecting belt 4 .
- connecting through holes 11 are arranged at equal intervals in the circumferential direction of the side wall of the anvil 1 , and the medical anastomosis connection device includes four connecting members 4 , which are fixedly connected to the reinforcement member 3 after passing through the corresponding connecting through holes 11 in sequence.
- the connecting through hole 11 may also be provided at other positions of the anvil 1, which is not limited thereto.
- the multiple connecting members 4 correspond to the multiple connecting through holes 11 one by one, and the multiple connecting belts 4 pass through the corresponding connecting through holes 11 in sequence and are fixedly connected to the reinforcement member 3, thereby improving the connection strength of the reinforcement member 3 and the anvil surface of the anvil seat 1, thereby improving the flatness of the contact surface of the reinforcement member 3 and the anvil surface, thereby improving the success rate of the surgical suture connection.
- a connecting structure 32 is provided at both the first connecting position and the second connecting position of the reinforcement 3, and the connecting structure 32 on the first connecting position is arranged correspondingly to the connecting structure 32 on the second connecting position.
- a connecting member 4 is also included, and the connecting member 4 has a first end and a second end connected. The first end passes through the connecting through hole 11 and is fixedly connected to the connecting structure 32 on the first connecting position of the reinforcement 3, and the first end is fixedly connected to the connecting structure 32 on the second connecting position of the reinforcement 3.
- the binding force of the fixed connection points where the first and second ends of the connector 4 match the connection structure 32 on the first connection position and the connection structure 32 on the second connection position of the reinforcement 3 exceeds 0.1N, and preferably, the binding force is greater than or equal to 0.5N.
- the reinforcement member 3 includes an annular gasket, on which at least one detachable connecting band 31 is disposed, and the detachable connecting band 31 extends from the inner edge of the annular gasket to the outer edge of the annular gasket.
- the shape of the annular gasket is a concentric circle, and the outer diameter of the annular gasket can be consistent with the outer diameter of the dowel seat 1, or slightly smaller or larger.
- the outer diameter of the annular gasket is consistent with the outer diameter of the dowel seat 1 in size and shape.
- the inner diameter of the annular gasket may be consistent in size and shape with the inner diameter of the anvil 1, or may be slightly smaller or larger.
- the inner diameter of the annular gasket is consistent in size and shape with the inner diameter of the dowel seat 1.
- the cutting part by setting the cutting part to be hollow, the cutting area between the tissue cutting knife and the cutting part is reduced, thereby reducing the cutting force of the tissue cutting knife, making it easier for the tissue cutting knife to separate the reinforcement 3 from the connecting part 4, thereby improving the cutting efficiency of the tissue cutting knife.
- connection strength of the reinforcement 3 itself is improved, thereby limiting the expansion limit of the suture opening, thereby improving the suture strength of the suture opening, avoiding the risk of suture opening tearing, and thus improving the success rate of the surgical suture connection opening.
- annular member 5 is added, fixedly connected to the annular member mounting groove 12 of the anvil seat, and the annular member 5 is arranged on the cutting stroke of the tissue cutting knife.
- the annular member 5 limits the movement stroke of the tissue cutting knife, thereby providing the tissue cutting knife with an abutment surface for cutting tissue, making it easier for the tissue cutting knife to cut tissue, thereby improving the cutting effect and cutting efficiency of the cutting knife, thereby ensuring the integrity of the tissue incision.
- the connecting arm provides an abutment surface for the tissue cutting knife, which facilitates the tissue cutting knife to cut the tissue; after the tissue cutting knife completes tissue cutting by abutting with the connecting arm, the tissue cutting knife can move into the annular groove 53, thereby reducing the cutting force of the tissue cutting knife, thereby improving the movement efficiency of the tissue cutting knife, and passing the tissue
- the cutting knife abuts against the inner wall of the annular member mounting groove 12, limiting the end point of the movement of the tissue cutting knife, thereby providing the operator with a prompt that the tissue cutting knife has moved into place.
- the annular member 5 is provided with an avoidance hole 55 matching the connecting through hole 11 ; the avoidance hole 55 passes through the inner ring member 51 and the outer ring member 52 ; and the first end of the connecting member 4 can pass through the connecting through hole 11 and the avoidance hole 54 in sequence.
- the circumference of the avoidance hole 55 is 1-20 mm.
- the connecting member 4 passes through the annular groove 53, and a cross bar 56 is also provided on the annular member 5; the cross bar 56 is provided in the annular groove 53, one end of the cross bar 56 is fixedly connected to the inner ring member 51, and the other end of the cross bar 56 is fixedly connected to the outer ring member 52; in the cutting direction, the cross bar 56 is placed above the connecting member 4.
- the number of crosspieces 56 may correspond to the number of connecting members 4 .
- the cross piece 56 may be an annular cross piece matching the annular groove 53 , and the cross piece 56 is placed above the connecting member 4 in the cutting direction.
- a crossbar abutment surface is provided on the side of the crossbar 56 facing the tissue cutting knife.
- the crossbar abutment surface can be parallel to the plane of the annular cutting abutment surface 54 of the annular member 5 or can be provided at a certain inclination angle to the plane of the annular cutting abutment surface 54 .
- a cross piece 56 is also provided on the annular member 5.
- the cross piece 56 is arranged in the annular groove 53.
- the connecting member passes through the annular groove 53.
- One end of the cross piece 56 is fixedly connected to the inner ring member 51, and the other end of the cross piece 56 is fixedly connected to the outer ring member 52.
- the cross piece 56 is placed above the connecting member 4, and the cross piece 56 provides an abutment effect for the tissue cutting knife to cut the connecting member 4, which facilitates the tissue cutting knife to cut off the connecting member 4, thereby separating the reinforcement member 3 from the nailing surface.
- an avoidance hole 55 matching the connecting through hole 11 is provided on the annular member 5; the avoidance hole 55 passes through the inner ring member 51 and the outer ring member 52; the connecting structure 32 on the reinforcement member 3 can pass through the connecting through hole 11 and the avoidance hole 54 in sequence and then be fixedly connected to the reinforcement member 3.
- the connecting structure 32 on the reinforcement member 3 passes through the annular groove 53, and a cross bar 56 is also provided on the annular member 5; the cross bar 56 is provided in the annular groove 53, one end of the cross bar 56 is fixedly connected to the inner ring member 51, and the other end of the cross bar 56 is fixedly connected to the outer ring member 52; in the cutting direction, the cross bar 56 is placed above the connecting structure 32 on the reinforcement member 3.
- annular abutment surface 13 is provided on the abutment surface of the staple holder 1, and a staple abutment groove 131 is provided on the annular abutment surface 13; when the staple holder 1 and the staple storage device 2 are in cooperation, the staples pushed out from the staple storage device 2 abut against the staple abutment groove 131.
- the staple abutment groove 131 is arranged in the circumferential direction of the annular abutment surface 13 .
- the staple abutment grooves 131 on the annular abutment surface 13 of the staple anvil 1 correspond to the positions of the staples in the staple storage 2 .
- a staple abutment groove 131 is provided on the staple anvil surface of the staple anvil 1.
- the staples abut against the staple abutment groove 131, thereby improving the effective deformation degree of the staples, thereby ensuring the suturing quality of the staples, thereby improving the suturing strength of the suture opening, avoiding the risk of suture opening tearing, and improving the success rate of the surgical suture connection opening.
- two circles of staple abutment grooves 131 may be arranged alternately on the annular abutment surface 13.
- the staple beam formed by bending the staples of one circle may be formed.
- the gap between the two adjacent staples of another circle is just blocked by the staple legs after being bent and formed, thereby preventing leakage and bleeding at the suture opening.
- the reinforcement 3 satisfies at least one of the following characteristics: the thickness of the reinforcement 3 is 0.01-1.5 mm; the surface smoothness of the reinforcement 3 is 0.1-60S; the bending stiffness of the reinforcement 3 is 0.01-6mN*m; and the air permeability of the reinforcement 3 is 0.1-200 ⁇ m/(Pa ⁇ s).
- the tensile strength of the reinforcement member 3 is 0.01-20 KN/m; the elongation at break of the reinforcement member 3 is 1%-200%.
- the thickness of the reinforcement 3 is 0.05-1.0 mm; the surface smoothness of the reinforcement 3 is 1-30S; the bending stiffness of the reinforcement 3 is 0.04-1mN*m; the air permeability of the reinforcement 3 is 1-200 ⁇ m/(Pa ⁇ s); the tensile strength of the reinforcement 3 is 0.1-5KN/m; and the elongation at break of the reinforcement 3 is 10%-150%.
- the performance parameters of the reinforcement member 3 are limited, so that the reinforcement member 3 has a good suture reinforcement effect during surgery, thereby avoiding the risk of suture tearing.
- the connector 4 satisfies at least one of the following characteristics: the thickness of the connector 4 is 0.01-1.5 mm; the width of the connector 4 is 0.02-110 mm.
- the thickness of the connecting member 4 is 0.05-1.0 mm, and the width of the connecting member 4 is 0.1-50 mm.
- the thickness of the connecting member 4 is set to be the same as the thickness of the reinforcing member 3 .
- the width of the connecting member 4 is smaller than the width of the connecting through hole 11 on the side wall of the nail seat 1, and smaller than the width of the avoidance hole 55 on the ring member 5.
- the thickness of the connecting member 4 is smaller than the thickness of the connecting through hole 11 on the side wall of the nail seat 1, and smaller than the thickness of the avoidance hole 55 on the ring member 5.
- the cutting force required for each connecting member 4 is required to be less than or equal to 50N.
- the cutting force required for each connecting member 4 is less than or equal to 1N.
- the connecting member 4 by limiting the width and thickness of the connecting member 4, it is convenient to assemble the connecting member 4 with the nail seat 1, and it is also convenient to reduce the cutting force of the tissue cutting knife cutting the connecting member 4, thereby improving the cutting efficiency of the tissue cutting knife, so that the reinforcement 3 is separated from the connecting member 4.
- the connecting through hole 11 passes through the anvil seat 1.
- the reinforcing member 3 is connected to the anvil seat 1 through the connecting through hole 11.
- the relative positions of the reinforcing member 3 and the anvil seat 1 are fixed, so that the abutting surface of the reinforcing member 3
- the fit with the anvil surface avoids the risk of the reinforcement member 3 being detached from the anvil seat 1 before surgery, and ensures the flatness of the abutment surface of the reinforcement member 3 and the anvil surface, thereby improving the connection strength of the suture connection.
- connection structure 32 protruding toward and away from the nail storage device 2; the connection structure 32 passes through the connecting through hole 11 and is fixedly connected to the reinforcement member 3; thereby, the abutting surface of the reinforcement member 3 is fitted with the nail abutting surface, thereby improving the stability of the connection between the reinforcement member 3 and the nail abutting seat 1, thereby improving the flatness of the abutting surface of the reinforcement member 3 and the nail abutting surface of the nail abutting seat.
- a connecting through hole 11 is provided on the side wall of the anvil seat 1, and a connecting member 4 passes through the connecting through hole 11 and is fixedly connected to the reinforcing member 3, thereby avoiding the phenomenon that the reinforcing member 3 falls off from the anvil seat 1 due to unreliable connection between the reinforcing member 3 and the anvil seat 1 before the operation, thereby improving the reliability of the fixed connection between the reinforcing member 3 and the anvil seat 1, and ensuring the flatness of the abutment surface of the reinforcing member 1 and the anvil surface, thereby making the puncture port of the staple neat and flat, and filling the gap between the staple and the tissue with the reinforcing member 3, reducing the slippage of the tissue during the surgical suturing process, and improving the effect of reinforcing the tissue, thereby reducing bleeding and exudation at the suture connection port, improving the success rate of the suturing operation, and reducing complications.
- a plurality of connecting members 4 are added, and a plurality of connecting through holes 11 are provided on the side wall of the anvil seat 1.
- the plurality of connecting members 4 correspond to the plurality of connecting through holes 11 one by one, and a plurality of connecting belts 4 sequentially penetrate the corresponding connecting through holes 11 and are fixedly connected to the reinforcing member 3, thereby improving the connection strength between the reinforcing member 3 and the anvil surface of the anvil seat 1, thereby improving the flatness of the fitting between the abutting surface of the reinforcing member 3 and the anvil surface, thereby improving the success rate of the surgical suture connection.
- At least one detachable connecting band 31 is provided on the annular gasket of the reinforcement member 3, and the detachable connecting band 31 extends from the outer edge of the annular gasket to the inner edge of the annular gasket.
- connection structure 32 is arranged at the detachable connection belt 31 of the reinforcement member 3, and the connection structure 32 is respectively connected to the solid parts on both sides of the detachable connection belt 31, thereby improving the strength of the reinforcement member 3.
- the connection strength of the suture itself limits the expansion limit of the suture, thereby improving the suture strength of the suture, avoiding the risk of suture tearing, and thus improving the success rate of surgical suture connection.
- annular member 5 is additionally provided, fixedly connected to the annular member mounting groove 12 of the anvil seat, and the annular member 5 is arranged on the cutting stroke of the tissue cutting knife.
- the annular member 5 limits the movement stroke of the tissue cutting knife, thereby providing the tissue cutting knife with an abutment surface for cutting tissue, making it easier for the tissue cutting knife to cut tissue, thereby improving the cutting effect and cutting efficiency of the cutting knife, thereby ensuring the integrity of the tissue incision.
- the annular member 5 includes an inner ring member 51, a connecting arm and an outer ring member 52, and one end of the inner ring member 51 and the outer ring member 52 are fixedly connected by the connecting arm, and an annular groove 53 is formed between the inner ring member 51 and the outer ring member 52.
- One side of the opening of the annular groove 53 abuts on the inner wall of the annular member mounting groove 12.
- the annular groove 53 is arranged on the cutting stroke of the tissue cutting knife.
- the connecting arm provides an abutting surface for the tissue cutting knife, which facilitates the tissue cutting knife to cut the tissue; after the tissue cutting knife completes tissue cutting by abutting with the connecting arm, the tissue cutting knife can move into the annular groove 53, thereby reducing the cutting force of the tissue cutting knife, thereby improving the movement efficiency of the tissue cutting knife, and by abutting the tissue cutting knife with the inner wall of the annular member mounting groove 12, the movement end point of the tissue cutting knife is limited, thereby providing the operator with a prompt that the tissue cutting knife has moved into place.
- a cross bar 56 is also provided on the annular member 5.
- the cross bar 56 is arranged in the annular groove 53.
- the connecting member passes through the annular groove 53.
- One end of the cross bar 56 is fixedly connected to the inner ring member 51, and the other end of the cross bar 56 is fixedly connected to the outer ring member 52.
- the cross bar 56 is placed above the connecting member 4, and the cross bar 56 provides an abutment effect for the tissue cutting knife to cut the connecting member 4, which facilitates the tissue cutting knife to cut off the connecting member 4, thereby separating the reinforcement member 3 from the nailing surface.
- a staple abutment groove 131 is provided on the staple anvil surface of the staple anvil 1.
- the staples abut against the staple abutment groove 131, thereby improving the effective deformation degree of the staples, thereby ensuring the suturing quality of the staples, thereby improving the suturing strength of the sutured opening, avoiding the risk of sutured opening tearing, and improving the success rate of the surgical suture connection opening.
- the circular tissue anastomosis connection device includes a nail anvil 1, a nail storage device 2, a reinforcement member 3 and four connecting members 4; the nail anvil 1 and the nail storage device 2 are used in combination; four connecting through holes 11 are arranged on the side wall of the nail anvil 1, the nail anvil 1 is provided with a nail anvil surface, and one side of the reinforcement member 3 is provided with a tissue contact surface and an abutment surface opposite to the tissue contact surface; the connecting member 4 has a first end and a second end that are connected, the first end passes through the connecting through hole 11, and the second end is arranged on the outside of the nail anvil 1; at least one of the first end and the second end extends toward the reinforcement member 3 and is fixedly connected to the reinforcement member 3; the abutment surface of the reinforcement member 3 is in contact with the nail anvil surface.
- the material of the reinforcement 3 is selected to be poly(lactide-glycol) (PLGA), and the thickness of the reinforcement 3 is 0.08mm, the surface smoothness is 25S, the bending stiffness is 0.8mN*m, the air permeability is 150 ⁇ m/(Pa ⁇ s), the tensile strength is 3KN/m and the elongation at break is 120%; the connecting member 4 is made of the same material as the reinforcement 3, and the thickness of the connecting member 4 is 0.5mm, and the width of the connecting member 4 is 35mm.
- PLGA poly(lactide-glycol)
- the four connecting through holes 11 are evenly spaced in the circumferential direction of the side wall of the anvil seat 1 .
- the connecting through holes 11 are in the shape of a quadrilateral.
- the connecting through holes 11 penetrate the side wall of the anvil seat 1 .
- the four connecting members 4 correspond to the four connecting through holes 11 one by one.
- the circular tissue anastomosis connection device also includes an annular member 5, which includes an inner ring member 51, a connecting arm and an outer ring member 52; one end of the inner ring member 51 and the outer ring member 52 are fixedly connected by the connecting arm; an annular groove 53 is formed between the inner ring member 51 and the outer ring member 52, and four avoidance holes 55 are also provided on the annular member 5; the four avoidance holes 55 are evenly distributed in the circumferential direction of the side wall of the annular member 5, and the avoidance holes 55 pass through the inner ring member 51 and the outer ring member 52.
- crosspieces 56 are arranged in the annular groove 53 , and two ends of the crosspieces 56 are fixedly connected to the inner ring member 51 and the outer ring member 52 respectively.
- annular member mounting groove 12 is provided on the nail support 1, and the annular member 5 is installed in the annular member mounting groove 12, and the connecting arm of the annular member 5 faces the side of the tissue cutting knife, and the opening side of the annular groove 53 of the annular member 5 abuts against the inner wall of the annular member mounting groove 12, and the avoidance hole 55 corresponds to the position of the connecting through hole 11.
- protruding structures are arranged at equal intervals on the first connection position of the reinforcement member 3, and four protruding structures are also arranged at the corresponding position of the second connection position.
- the first end of the connector 4 is passed through the connecting hole 11 and the avoidance hole 54 in sequence, and then the first end of the connector 4 is fixedly connected to the protruding structure on the first connecting position by a hot pressing process, and the second end of the connector 4 is fixedly connected to the protruding structure on the second connecting position.
- the circular tissue anastomosis connection device also includes a nail storage device 2 used in conjunction with the nail support seat 1, wherein the nail storage device 2 is provided with an anastomosis staple, and the annular abutment surface 13 of the nail support seat 1 has an anastomosis staple abutment groove 131, and the anastomosis staple abutment groove 131 is used to abut against the anastomosis staple; a tissue cutting knife is also installed in the nail storage device 2, and when the nail support seat 1 and the nail storage device 2 are in cooperation, the tissue cutting knife can move toward the nail support seat 1 along the cutting direction, and the tissue cutting knife abuts against the annular cutting abutment surface 54 on the annular member 5, thereby being able to cut off the excess tissue, and the tissue cutting knife abuts against the cross piece 56 on the annular member 5, thereby cutting off the first end of the connecting member 4 from the reinforcing member 3; at the same time, the anastomosis staple in the
- No protruding structure is provided on the reinforcement member 3 , and the first end of the connecting member 4 passes through the connecting through hole 11 and the avoidance hole 54 in sequence, and then the first end and the second end of the connecting member 4 are fixedly connected to the reinforcement member 3 respectively through a hot pressing process.
- the difference between the third embodiment and the first embodiment is that the third embodiment does not include the connecting member 4.
- the similarities with the first embodiment are not repeated here.
- the differences between the second embodiment and the first embodiment are described as follows:
- protruding structures are arranged at equal intervals on the first connection position of the reinforcement member 3, and four protruding structures are also arranged at corresponding positions of the second connection position, and the length of the protruding structure on the first connection position is greater than that of the protruding structure on the second connection position.
- connecting through holes 11 are evenly spaced in the circumferential direction of the side wall of the anvil seat 1, and the positions of the connecting through holes 11 match the positions of the protruding structures on the first connecting position and the protruding structures on the second connecting position one by one.
- the circular tissue anastomosis connection device also includes a nail storage device 2 used in conjunction with the nail support seat 1, wherein the nail storage device 2 is provided with an anastomosis staple, and the anastomosis staple abutment groove 131 on the annular abutment surface 13 of the nail support seat 1 is abutted against the anastomosis staple; a tissue cutting knife is also installed in the nail storage device 2, and when the nail support seat 1 and the nail storage device 2 are in cooperation, the tissue cutting knife can move toward the nail support seat 1 along the cutting direction, and the tissue cutting knife abuts against the annular cutting abutment surface 54 on the annular member 5, thereby being able to cut off the excess tissue, and the tissue cutting knife abuts against the cross piece 56 on the annular member 5, thereby cutting off the protruding structure on the reinforcement member 3; at the same time, the anastomosis staple in the nail storage device 2 passes through the tissue and the reinforcement member 3 in turn and abuts against the an
- the difference between the fourth embodiment and the first embodiment is that the structural arrangement of the reinforcement member 3 is different.
- 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 reinforcement member includes an annular gasket, on which four detachable connecting bands 31 are evenly distributed.
- the detachable connecting band 31 extends from the inner edge of the annular gasket to the outer edge of the annular gasket.
- the detachable connecting band 31 is evenly spaced from the first connection position of the reinforcement member 3 and four convex structures are also arranged at the corresponding positions of the second connection position.
- the convex structure of the reinforcement member 3 is arranged at the detachable connecting band 31, and the convex structures are respectively connected to the solid parts on both sides of the detachable connecting band 31.
- the ring member 5 is installed in the ring member installation groove 12 of the anvil seat 1, and the opening side of the annular groove 53 of the ring member 5 abuts against the inner wall of the ring member installation groove 12, and the avoidance hole 55 on the ring member 5 is aligned with the inner wall of the annular groove 53 of the annular member 5.
- the positions of the connecting through holes 11 on the dowel seat 1 correspond to each other; then the first end of the connecting member 4 is passed through the connecting through hole 11 and the avoidance hole 55 in sequence, and finally the first end is hot-pressed connected to the raised structure on the first connecting position on the reinforcement member 3, and the second end of the connecting member 4 is hot-pressed connected to the raised structure on the second connecting position on the reinforcement member 3, thereby achieving a fixed connection between the reinforcement member 3 and the dowel seat 1.
- the reinforcement 3 is fixedly connected to the nail seat 1.
- the staples in the nail storage device 2 can penetrate the tissue and the reinforcement 3 in turn, and then abut against the staple abutting groove of the nail seat 1, and the reinforcement 3 is fixed to the tissue through the deformation of the staples.
- the tissue cutting knife in the nail storage device 2 moves toward the nail seat 1 along the cutting direction, and the tissue cutting knife abuts against the annular cutting abutting surface 54 on the annular member 5, so that the excess tissue can be cut off.
- the tissue cutting knife abuts against the cross piece 56 on the annular member 5, and then the first end of the connecting member 4 is cut off from the reinforcement 3.
- the nail seat 1 is taken out from the suture opening.
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- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
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Abstract
L'invention concerne un dispositif de connexion anastomotique médical, comprenant une enclume (1), une cartouche (2) et un raidisseur (3), l'enclume (1) et la cartouche (2) étant utilisées de manière coopérative ; une paroi latérale de l'enclume (1) est pourvue d'au moins un trou traversant de liaison (11) ; l'enclume (1) est pourvue d'une face d'enclume ; le raidisseur (3) est disposé sur un côté avec une face de contact de tissu et une face de butée opposée à la face de contact de tissu ; le trou traversant de liaison (11) est agencé pénétrant dans l'enclume (1), et le raidisseur (3) est relié à l'enclume (1) au moyen du trou traversant de liaison (11) ; après que le raidisseur (3) est relié à l'enclume (1), le raidisseur (3) est fixé par rapport à l'enclume (1) ; et la face de butée du raidisseur (3) s'adapte à la face d'enclume. Dans le dispositif de connexion anastomotique médical, au moyen du trou traversant de liaison (11) qui est agencé pénétrant dans l'enclume (1), le raidisseur (3) est relié à l'enclume (1), et le raidisseur (3) est fixé par rapport à l'enclume (1) ; et la face de butée du raidisseur (3) s'adapte à la face d'enclume. De cette manière, il est possible d'éviter le risque de désengagement du raidisseur (3) de l'enclume (1) avant la chirurgie, et d'assurer la planéité de l'ajustement entre la face de butée du raidisseur (3) et la face d'enclume, ce qui permet d'améliorer la force de connexion de la jonction de connexion agrafée.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310300778.3A CN116421247A (zh) | 2023-03-24 | 2023-03-24 | 一种医用吻合连接装置 |
| CN202310300778.3 | 2023-03-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024197877A1 true WO2024197877A1 (fr) | 2024-10-03 |
Family
ID=87086484
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2023/085646 Ceased WO2024197877A1 (fr) | 2023-03-24 | 2023-03-31 | Dispositif de connexion anastomotique médical |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN116421247A (fr) |
| WO (1) | WO2024197877A1 (fr) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1719461A2 (fr) * | 2002-06-17 | 2006-11-08 | Tyco Healthcare Group Lp | Élément de support annulaire |
| CN202446171U (zh) * | 2011-12-16 | 2012-09-26 | 北京中法派尔特医疗设备有限公司 | 一种新型抵钉座组件 |
| CN103565488A (zh) * | 2012-07-18 | 2014-02-12 | 柯惠Lp公司 | 包括手术支撑件的手术装置 |
| CN106923875A (zh) * | 2015-12-31 | 2017-07-07 | 苏州天臣国际医疗科技有限公司 | 一种手术吻合器 |
| CN107320145A (zh) * | 2017-08-21 | 2017-11-07 | 北京天钥医疗器械有限公司 | 压迫止血脱钉装置及采用该装置的包皮环切吻合器 |
| CN209032499U (zh) * | 2018-02-05 | 2019-06-28 | 赵舒 | 一种吻合组件以及具有该吻合组件的吻合器 |
| CN111150446A (zh) * | 2018-11-07 | 2020-05-15 | 柯惠Lp公司 | 圆形eea缝合器的支撑件 |
| CN211243541U (zh) * | 2019-07-17 | 2020-08-14 | 施爱德(厦门)医疗器材有限公司 | 可降解吻合组件 |
| CN116138830A (zh) * | 2023-03-24 | 2023-05-23 | 苏州卡夫思曼医疗科技有限公司 | 一种圆形组织缝合装置 |
-
2023
- 2023-03-24 CN CN202310300778.3A patent/CN116421247A/zh not_active Withdrawn
- 2023-03-31 WO PCT/CN2023/085646 patent/WO2024197877A1/fr not_active Ceased
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1719461A2 (fr) * | 2002-06-17 | 2006-11-08 | Tyco Healthcare Group Lp | Élément de support annulaire |
| CN202446171U (zh) * | 2011-12-16 | 2012-09-26 | 北京中法派尔特医疗设备有限公司 | 一种新型抵钉座组件 |
| CN103565488A (zh) * | 2012-07-18 | 2014-02-12 | 柯惠Lp公司 | 包括手术支撑件的手术装置 |
| CN106923875A (zh) * | 2015-12-31 | 2017-07-07 | 苏州天臣国际医疗科技有限公司 | 一种手术吻合器 |
| CN107320145A (zh) * | 2017-08-21 | 2017-11-07 | 北京天钥医疗器械有限公司 | 压迫止血脱钉装置及采用该装置的包皮环切吻合器 |
| CN209032499U (zh) * | 2018-02-05 | 2019-06-28 | 赵舒 | 一种吻合组件以及具有该吻合组件的吻合器 |
| CN111150446A (zh) * | 2018-11-07 | 2020-05-15 | 柯惠Lp公司 | 圆形eea缝合器的支撑件 |
| CN211243541U (zh) * | 2019-07-17 | 2020-08-14 | 施爱德(厦门)医疗器材有限公司 | 可降解吻合组件 |
| CN116138830A (zh) * | 2023-03-24 | 2023-05-23 | 苏州卡夫思曼医疗科技有限公司 | 一种圆形组织缝合装置 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN116421247A (zh) | 2023-07-14 |
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