Near-end anastomotic stoma reinforcing assembly, reinforcing suite and circular anastomat

Abstract

The utility model discloses a near-end anastomotic stoma reinforcing assembly, a reinforcing suite and a circular anastomat, and relates to the technical field of medical instruments, the near-end anastomotic stoma reinforcing assembly is characterized in that the near-end anastomotic stoma reinforcing assembly comprises a near-end reinforcing piece and a near-end fixing assembly, the near-end reinforcing piece comprises an end face part and a cylindrical surface connecting part, the end face part is a circular ring piece, and the cylindrical surface connecting part is connected with the near-end fixing assembly. The top end of the cylindrical surface connecting part is fixed on the bottom surface of the end surface part; the inner side surface of the cylindrical surface connecting part is aligned with the inner side annular edge of the end surface part; a plurality of bulges are arranged on the bottom surface of the end face part; the bulge is used for being embedded into a bin hole of a single nail in a nail bin of the circular anastomat; and the near-end fixing assembly is detachably connected with the cylindrical surface connecting part and a nail barrel of the circular anastomat. According to the circular anastomat, the problems of friction and adhesion between the near-end reinforcing sheet and tissues are solved, the possibility that the near-end reinforcing sheet moves on the circular anastomat and wrinkles are formed is reduced, and meanwhile the problem that the reinforcing effect of the near-end reinforcing sheet is affected due to edge warping of the near-end reinforcing sheet in the anastomosis process is solved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and more specifically, to a proximal anastomotic reinforcement component, a reinforcement kit and a circular stapler. Background Art

[0002] Staplers include linear staplers and circular staplers, which can staple tissues with staples while cutting, and are widely used in the reconstruction of organs such as intestines, stomachs, lungs, and pancreas, as well as tissue cutting, suturing, or anastomosis. The cutting and anastomosis portion of the circular stapler includes two parts, one of which is a staple anvil assembly having an umbrella-like or mushroom-like shape, and the other is a stapler cartridge assembly of the stapler. The stapler cartridge assembly includes a stapler cartridge and is also provided with an annular knife for cutting tissue. The circular stapler can form an annular staple line on the tissue, and use the annular knife to cut the tissue to form a circular anastomosis. This instrument can be used to conveniently anastomose tubular organs, and is usually used in esophageal, intestinal, or gastrointestinal surgery. Compared with conventional surgery that first uses a scalpel or surgical scissors to open, the circular stapler greatly reduces the risk of such surgical procedures and shortens the operation time, and is therefore widely used in surgical operations. However, the hard stapling of staples alone cannot completely avoid bleeding and leakage of anastomotic tissue. This is because the anastomotic staples are rigid structures that cannot fully match the flexibility of soft tissues, resulting in bleeding from the staple holes and leakage from the closed cut end surface. To solve the above problems, the anastomotic stoma reinforcement patch can be used in conjunction with the stapler, so that while the stapler is cutting and closing the wound surface, the reinforcement patch is fixed to the wound surface to block the stapler holes, improve the wound surface strength, and thus avoid leakage and bleeding from the wound surface.

[0003] The prior art CN117379127A discloses a technical solution in which two reinforcement patches are respectively sleeved on the anvil assembly of a circular stapler and the stapler cartridge assembly of a circular stapler. In this solution, the reinforcement patches have an extension along the axial direction of the circular stapler on both the inner and outer sides of the circular stapler. These extensions will have frictional contact with the circular stapler to increase the connection stability between the reinforcement patches and the circular stapler. The extension of the reinforcement patches located on the outer side of the circular stapler is prone to adhesion and friction with the inner mucosa of the tissue when the circular stapler enters the tissue cavity or the end face purse, which will cause the reinforcement patches to wrinkle or move away from the circular stapler, bringing safety hazards to tissue anastomosis, and even lead to anastomosis failure in severe cases.

[0004] In response to this problem, the prior art CN115211918A discloses a technical solution in which two reinforcement patches are detachably connected to the circular stapler anvil assembly and the circular stapler stapler magazine assembly through fixings. In this solution, the reinforcement patches only have an extension along the axial direction of the circular stapler on the inner side of the circular stapler. This extension is detachably connected to the circular stapler through fixings, which solves the problem of adhesion and friction between the reinforcement patches and the inner mucosa of the tissue. However, in this solution, there is no connection between the reinforcement patches and the end faces of the circular stapler anvil assembly and the circular stapler magazine assembly. During the anastomosis process, the reinforcement patches are easily warped by the anastomosis staples, so that they cannot accurately fit the anastomotic opening, affecting the reinforcement effect. In severe cases, it may even lead to reinforcement failure. Utility Model Content

[0005] In view of the problems in the prior art of adhesion and friction between the reinforcement patch and the inner mucosa of the tissue, and the lack of connection between the reinforcement patch and the end faces of the circular stapler anvil assembly and the circular stapler stapler magazine assembly, the reinforcement patch is easily warped due to the influence of the anastomotic staples during the anastomosis process and cannot accurately fit the anastomotic stoma, the purpose of the utility model is to provide a proximal anastomotic stoma reinforcement assembly, a reinforcement kit and a circular stapler to solve the above-mentioned problems.

[0006] The utility model provides a proximal anastomotic reinforcement component, which includes a proximal reinforcement sheet and a proximal fixing component, wherein the proximal reinforcement sheet includes an end face portion and a cylindrical connecting portion, wherein the end face portion is a circular ring sheet, wherein the top end of the cylindrical connecting portion is fixed to the bottom surface of the end face portion, and the inner side surface of the cylindrical connecting portion is aligned with the inner annular edge of the end face portion. The bottom surface of the end face portion has a plurality of protrusions. The protrusions are used to be embedded in the magazine hole of a single nail in the nail magazine of a circular stapler. The proximal fixing component is used to detachably connect the cylindrical connecting portion with the nail barrel of the circular stapler.

[0007] The utility model is further configured as follows: the proximal reinforcement sheet has at least one first incision, the first incision divides the end face portion and the cylindrical connection portion along the axis direction of the cylindrical connection portion, and the two cut surfaces at a single first incision can fit each other. When there are multiple first incisions, all the first incisions divide the proximal reinforcement sheet into multiple parts distributed around the axis of the cylindrical connection portion. Each part of the proximal reinforcement sheet is connected to the proximal fixing assembly.

[0008] The utility model is further configured as follows: the proximal fixing assembly is an annular structure with a single opening, or the proximal fixing assembly is composed of a plurality of components distributed around the axis of the cylindrical connecting portion.

[0009] The utility model is further configured as follows: the proximal fixing assembly includes a tension ring, the tension ring includes a plurality of arc-shaped parts, each arc-shaped part is provided with a first plug-in portion and a first plug-in groove, all arc-shaped parts are distributed around the axis of the cylindrical connecting part, and two adjacent arc-shaped parts are connected together through the plug-in cooperation of the first plug-in portion and the first plug-in groove. The cylindrical connecting part is fixedly connected to the tension ring, the tension ring is tightened on the inner side of the nail barrel of the circular stapler, and the tension ring is located on the inner side of the annular knife of the circular stapler.

[0010] The utility model is further configured as follows: the proximal fixing assembly can also be replaced with the following structure, which includes a bracket and a buckle, and the bracket is provided in plurality, and each bracket is fixedly connected to the cylindrical connecting part and the circular stapler. The cylindrical connecting part is provided with a plurality of first buckle grooves distributed around the axis of the cylindrical connecting part, and a buckle passing through the top end of the bracket is clamped in each first buckle groove. The circular stapler is provided with a plurality of second buckle grooves distributed around the axis of the circular stapler, and a buckle passing through the bottom end of the bracket is clamped in each second buckle groove.

[0011] The utility model is further configured as follows: there are multiple first incisions.

[0012] The utility model is further configured as follows: a groove is arranged on the top of the end surface portion, and a groove is arranged inside each protrusion.

[0013] The utility model is further configured such that: the vertical distance from the lowest point of the protrusion to the bottom surface of the end face portion is greater than or equal to 0.1 mm.

[0014] The utility model is further configured as follows: the proximal reinforcement sheet is a degradable biological reinforcement sheet.

[0015] The utility model is further configured as follows: the thickness of the end surface portion is less than or equal to 0.3 mm.

[0016] The utility model also provides a reinforcement kit, which includes the above-mentioned proximal anastomotic reinforcement assembly and distal anastomotic reinforcement assembly. The distal reinforcement assembly includes a distal reinforcement sheet and a distal fixing assembly, and the distal fixing assembly includes an internal fixing member and an external fixing member, the internal fixing member and the external fixing member are detachably connected, and the distal reinforcement sheet is clamped between the internal fixing member and the external fixing member. The distal reinforcement sheet, the internal fixing member and the external fixing member all have a through hole for accommodating the central axis of the circular stapler, and the through hole axes of the three are collinear. In the radial direction of the three through holes, the internal fixing member and the external fixing member do not exceed the outer edge of the distal reinforcement sheet, and the through hole diameter of the external fixing member and the through hole diameter of the distal reinforcement sheet are both greater than or equal to the through hole diameter of the internal fixing member. The internal fixing member is used for detachably connecting the central axis of the circular stapler.

[0017] The utility model is further configured as follows: the inner fixing member is an elastic fixing member, which is tightly fixed on the central axis of the circular stapler through friction force.

[0018] The utility model is further configured as follows: a plurality of elastic fastening strips are arranged on the inner side of the inner fixing member, and all the elastic fastening strips are parallel to the axis of the inner fixing member and are distributed around the axis of the inner fixing member.

[0019] The utility model is further configured as follows: the distal reinforcing sheet has at least one second incision, the second incision divides the distal reinforcing sheet along the axis direction of the distal reinforcing sheet, and the two cut surfaces at a single second incision can fit each other. When there are multiple second incisions, all the second incisions divide the distal reinforcing sheet into multiple parts distributed around the axis of the distal reinforcing sheet.

[0020] The utility model is further configured as follows: the inner fixing member has at least one third cutout, and the third cutout divides the inner fixing member along the axis direction of the inner fixing member. When there are multiple third cutouts, all the third cutouts divide the inner fixing member into multiple parts distributed around the axis of the inner fixing member. Two adjacent parts of the inner fixing member can be detachably connected.

[0021] The external fixing member has at least one fourth cutout, which divides the external fixing member along the axis of the external fixing member. When there are multiple fourth cutouts, all the fourth cutouts divide the external fixing member into multiple parts distributed around the axis of the external fixing member.

[0022] The utility model is further configured as follows: the distal reinforcing piece has a plurality of second incisions, the inner fixing piece has a plurality of third incisions, and the outer fixing piece has a plurality of fourth incisions.

[0023] The utility model is further configured as follows: each part of the inner fixing member is provided with a second plug-in portion and a second plug-in slot, and two adjacent parts of the inner fixing member are connected together through the plug-in cooperation of the second plug-in portion and the second plug-in slot.

[0024] The utility model is further configured as follows: the distal reinforcement component also includes a fastening piece, a plurality of fastening pieces are provided, all of which are distributed around the axis of the internal fixing piece, the fastening piece passes through the external fixing piece and the distal reinforcement sheet, and is inserted into the internal fixing sheet to be clamped with the internal fixing sheet.

[0025] The utility model is further configured as follows: the distal reinforcement sheet is a degradable biological reinforcement sheet.

[0026] The utility model is further configured as follows: the thickness of the distal reinforcement sheet is less than or equal to 0.3 mm.

[0027] The utility model also provides a circular stapler, which includes the above-mentioned reinforcement kit, a nail barrel, a nail anvil and a central shaft. The nail barrel is fixed with a nail magazine and an annular knife, the nail anvil is fixed with a nail anvil and a knife anvil, the central shaft is fixedly connected to the nail anvil, and the central shaft is fixedly connected or detachably connected to the nail barrel.

[0028] The end surface is attached to the end surface of the nail magazine, and at most one protrusion is embedded in the magazine hole of each single nail in the nail magazine. The cylindrical connecting part is located inside the annular knife and is detachably connected to the nail barrel through a proximal fixing assembly.

[0029] The inner fixing member is detachably connected to the central axis, and the distal reinforcing sheet is in contact with the end surface of the nail anvil. When the annular knife is against the anvil, the distal fixing assembly is located inside the annular knife.

[0030] The utility model is further configured as follows: in the radial direction of the anvil, the distance between the outer edge of the inner fixing piece and the inner edge of the anvil is greater than or equal to 2 mm, and the distance between the outer edge of the outer fixing piece and the inner edge of the anvil is greater than or equal to 2 mm.

[0031] The utility model is further configured as follows: the distance between the outer wall of the cylindrical connecting portion and the inner wall of the annular knife is greater than or equal to 2 mm.

[0032] In summary, the utility model has the following beneficial effects compared with the prior art: the proximal reinforcing sheet in the utility model only has an extension along the axial direction of the circular stapler on the inner side of the circular stapler, and this extension is detachably connected to the circular stapler through the proximal fixing assembly, which solves the problem of friction and adhesion between the proximal reinforcing sheet and the tissue, and reduces the possibility of the proximal reinforcing sheet moving on the circular stapler and forming wrinkles. In addition, the protrusion on the proximal reinforcing sheet in the utility model increases the connection strength between the proximal reinforcing sheet and the stapler magazine of the circular stapler, reduces the possibility of the proximal reinforcing sheet warping during the anastomosis process, and enables the proximal reinforcing sheet to accurately fit the anastomotic opening, thereby ensuring the reinforcement effect. On this basis, the utility model also provides a reinforcement assembly, wherein the proximal anastomotic opening reinforcement assembly and the distal anastomotic opening reinforcement assembly are both arranged as split structures, which are installed on the existing circular stapler without changing the existing circular stapler structure, and can realize the structural improvement of the existing circular stapler very simply and at low cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a schematic diagram of the structure of the proximal anastomotic reinforcement assembly in Example 1;

[0034] Figure 2 A schematic diagram showing the groove in Example 1;

[0035] Figure 3 This is a schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 1 being installed on the staple barrel in the circular stapler;

[0036] Figure 4 It is a cross-sectional schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 1 installed on the staple barrel in the circular stapler;

[0037] Figure 5 A partially enlarged schematic diagram showing the relative position relationship between the groove and the staple in Example 1;

[0038] Figure 6 This is a schematic diagram of the structure of the proximal anastomotic reinforcement assembly in Example 2;

[0039] Figure 7 This is a schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 2 being installed on the staple barrel in the circular stapler;

[0040] Figure 8 It is a cross-sectional schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 2 installed on the staple barrel in the circular stapler;

[0041] Fig. 9 This is a schematic diagram of the bottom structure of the distal anastomotic reinforcement component in Example 3;

[0042] Fig.10 It is a schematic diagram of the top surface structure of the distal anastomotic reinforcement component in Example 3;

[0043] Fig.11 This is a schematic diagram of the bottom structure of the distal anastomotic reinforcement component in Example 4;

[0044] Fig.12 It is a schematic diagram of the top surface structure of the distal anastomotic reinforcement component in Example 4;

[0045] Fig.13 is a schematic diagram of the overall structure of the circular stapler in Example 5;

[0046] Fig.14 This is a schematic diagram of the explosion structure of the circular stapler in Example 5 after the firing handle is removed;

[0047] Fig.15 A partial structural diagram showing the relative positions of the inner fixing member, the outer fixing member and the knife anvil in Embodiment 5;

[0048] Fig.16 This is a partially enlarged schematic diagram showing the relative positions of the cylindrical connecting portion and the annular knife in Example 5;

[0049] Fig.17 is a schematic structural diagram of a circular stapler in Example 6;

[0050] Fig.18 This is a schematic diagram of the nail barrel and the central axis after being separated in Example 6.

[0051] In the figure: 1, proximal anastomotic reinforcement component; 11, proximal reinforcement sheet; 111, end face; 112, cylindrical connection part; 113, protrusion; 114, first incision; 115, groove; 12, proximal fixing component; 121, arc-shaped member; 1211, first plug-in part; 1212, first plug-in groove; 122, bracket; 123, buckle; 2, distal anastomotic reinforcement component; 21, distal reinforcement sheet; 211, second Incision; 22, distal fixing assembly; 221, internal fixing member; 2211, elastic fastening strip; 2212, third incision; 2213, second plug-in portion; 2214, second plug-in slot; 222, external fixing member; 2221, fourth incision; 223, snap-fit ​​member; 3, nail barrel; 31, nail magazine; 311, magazine hole; 32, annular knife; 4, nail support; 41, nail anvil; 42, knife anvil; 5, central axis; 6, anastomosis staple. DETAILED DESCRIPTION

[0052] The technical solution of the utility model will be clearly described below in conjunction with the accompanying drawings. Obviously, the described embodiments are not all embodiments of the utility model. All other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the utility model.

[0053] It should be noted that the terms "center", "up", "down", "horizontal", "left", "right", "front", "back", "lateral", "longitudinal", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the utility model and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the utility model.

[0054] The distal end and the proximal end in the present invention refer to the position of the instrument when the doctor is performing surgery. The end closer to the doctor is the proximal end, and the end farther from the doctor is the distal end.

[0055] Example 1

[0056] like Figure 1-5As shown, the proximal anastomotic reinforcement assembly in Example 1 of the utility model includes a proximal reinforcement sheet 11 and a proximal fixing assembly 12. The proximal reinforcement sheet 11 includes an end face portion 111 and a cylindrical connecting portion 112. The end face portion 111 is a circular ring sheet. The top end of the cylindrical connecting portion 112 is fixed to the bottom surface of the end face portion 111. The inner side surface of the cylindrical connecting portion 112 is aligned with the inner annular edge of the end face portion 111. The bottom surface of the end face portion 111 has a plurality of protrusions 113. The protrusions 113 are used to be embedded in the magazine hole 311 of a single nail in the nail magazine 31 of the circular stapler. The proximal fixing assembly 12 is used to detachably connect the cylindrical connecting portion 112 with the nail barrel 3 of the circular stapler. In this embodiment, the distribution of the protrusions 113 is consistent with the distribution of the single nail magazine holes 311 of the circular stapler in which they are located, so that a protrusion 113 is embedded in each single nail magazine hole 311, and the protrusions 113 are distributed in a ring shape around the center line of the cylindrical connecting portion 112.

[0057] In this embodiment, the proximal reinforcement sheet 11 only has an extension along the axial direction of the circular stapler on the inner side of the circular stapler. This extension is detachably connected to the circular stapler through the proximal fixing assembly 12, which solves the problem of friction and adhesion between the proximal reinforcement sheet 11 and the tissue, and reduces the possibility of the proximal reinforcement sheet 11 moving on the circular stapler and forming wrinkles. In addition, the protrusion 113 on the proximal reinforcement sheet 11 in this embodiment increases the connection strength between the proximal reinforcement sheet 11 and the circular stapler stapler magazine 31, reduces the possibility of the proximal reinforcement sheet 11 warping during the anastomosis process, and enables the proximal reinforcement sheet 11 to accurately fit the anastomotic opening, ensuring the reinforcement effect.

[0058] Specifically, in this embodiment, the vertical distance from the lowest point of the protrusion 113 to the bottom surface of the end surface portion 111 is greater than or equal to 0.1 mm.

[0059] Specifically, the proximal reinforcement sheet 11 has at least one first incision 114, and the first incision 114 divides the end face portion 111 and the cylindrical connection portion 112 along the axial direction of the cylindrical connection portion 112, and the two cut surfaces at a single first incision 114 can fit each other. When there are multiple first incisions 114, all first incisions 114 divide the proximal reinforcement sheet 11 into multiple parts distributed around the axis of the cylindrical connection portion 112. Each part of the proximal reinforcement sheet 11 is connected to the proximal fixing assembly 12. The setting of the first incision 114 allows the proximal reinforcement sheet 11 to ensure that 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 circular stapler from the anastomosis, reducing the risk of anastomotic tearing during the removal of the circular stapler from the anastomosis, and thus improving the success rate of the operation. In addition, the central axis 5 of the circular stapler can enter and exit the proximal reinforcing plate 11 through the first incision 114, so as to facilitate the assembly and disassembly of the proximal reinforcing plate 11 on the existing circular stapler without changing the structure of the existing circular stapler.

[0060] Specifically, the proximal fixing assembly 12 is an annular structure with a single opening, or the proximal fixing assembly 12 is composed of a plurality of components distributed around the axis of the cylindrical connecting portion 112. The central axis 5 of the circular stapler can enter and exit the proximal fixing assembly 12 from the opening of the proximal fixing assembly 12 or from the gap between two adjacent components in the proximal fixing assembly 12, so as to realize the disassembly and assembly of the proximal fixing assembly 12 on the existing circular stapler without changing the structure of the existing circular stapler.

[0061] Specifically, there are a plurality of first cutouts 114, and it is best if all the first cutouts 114 are evenly distributed around the axis of the cylindrical connecting portion 112. In this embodiment, there are two first cutouts 114.

[0062] Specifically, a groove 115 is provided at the top of the end surface 111, and each protrusion 113 has a groove 115 inside, so that when the staple 6 is pushed out of the magazine hole 311 of the staple magazine 31 of the circular stapler, the protrusion 113 is deformed and smoothly escapes from the magazine hole 311, thereby ensuring the fitting effect between the proximal reinforcing sheet 11 and the anastomotic opening. At the same time, the provision of the groove 115 enables the protrusion 113 to be pressed and formed on the end surface 111 by a mold, which helps to reduce the difficulty of processing the protrusion 113 on the end surface 111.

[0063] Specifically, the proximal reinforcement sheet 11 described in this embodiment is a degradable biological reinforcement sheet. The material of the degradable biological reinforcement sheet includes completely degradable and absorbable biomaterials from animal sources and / or completely degradable and absorbable polymer biomaterials and / or completely degradable and absorbable biomaterials synthesized from animal sources and polymers. The degradable biological reinforcement sheet can provide sufficient mechanical tension during the tissue healing process to prevent the anastomosis staples 6 from damaging the surrounding tissues. After the tissue is healed, the degradable biomaterials will degrade on their own and will not cause harmful effects to the human body.

[0064] Specifically, the thickness of the end surface portion 111 is less than or equal to 0.3 mm to ensure that the annular knife 32 of the circular stapler can smoothly cut the end surface portion 111 .

[0065] In this embodiment, the proximal fixing assembly 12 is composed of a plurality of components distributed around the axis of the cylindrical connection portion 112. Specifically, the proximal fixing assembly 12 includes a tensioning ring, which includes a plurality of arc-shaped members 121. Each arc-shaped member 121 is provided with a first plug-in portion 1211 and a first plug-in groove 1212. All arc-shaped members 121 are distributed around the axis of the cylindrical connection portion 112. Two adjacent arc-shaped members 121 are connected together by plugging and matching the first plug-in portion 1211 with the first plug-in groove 1212. The cylindrical connection portion 112 is fixedly connected to the tensioning ring, which is tightened on the inner side of the nail barrel 3 of the circular stapler. The tensioning ring is located on the inner side of the annular knife 32 of the circular stapler. The structural design of the plug-in connection of multiple arc-shaped members 121 can realize the disassembly and assembly of the proximal fixing assembly 12 on the existing circular stapler without changing the structure of the existing circular stapler. In this embodiment, two arc-shaped members 121 are provided.

[0066] Specifically, the cylindrical connection part 112 is divided into multiple parts by multiple first cuts 114, which correspond to all the arc-shaped parts 121. Each arc-shaped part 121 is fixedly connected to its corresponding cylindrical connection part 112. In this embodiment, each arc-shaped part 121 is fixedly connected to its corresponding cylindrical connection part 112 by an adhesive layer.

[0067] Preferably, on the basis of this embodiment, the tension ring and the stapler barrel 3 of the circular stapler can be relatively fixed in position, and the annular knife 32 and the relatively fixed structure of the annular knife 32 are not in contact with the tension ring and the cylindrical connecting portion 112, so as to reduce the interference of the tension ring and the cylindrical connecting portion 112 on the movement of the annular knife 32. It should be noted that this preferred solution is not shown in the figure.

[0068] Example 2

[0069] like Figure 6-8As shown, the proximal anastomotic reinforcement assembly in Example 2 of the utility model. In this embodiment, the proximal fixing assembly 12 is also composed of a plurality of components distributed around the axis of the cylindrical connecting portion 112. The difference between this embodiment and Example 1 is that the structure of the proximal fixing assembly 12 is different. Specifically, the proximal fixing assembly 12 includes a bracket 122 and a buckle 123. The bracket 122 is provided in plurality, and each bracket 122 is fixedly connected to the cylindrical connecting portion 112 and the circular stapler. The cylindrical connecting portion 112 is provided with a plurality of first buckle grooves distributed around the axis of the cylindrical connecting portion 112, and a buckle 123 passing through the top of the bracket 122 is clamped in each first buckle groove. The circular stapler is provided with a plurality of second buckle grooves distributed around the axis of the circular stapler, and a buckle 123 passing through the bottom of the bracket 122 is clamped in each second buckle groove. All brackets 122 are independent of each other, and the proximal fixing assembly 12 can be disassembled and assembled on the existing circular stapler without changing the structure of the existing circular stapler.

[0070] In this embodiment, all the brackets 122 are evenly distributed around the axis of the cylindrical connecting portion 112, and the top and bottom of each bracket 122 are respectively connected to a buckle 123. In this embodiment, four brackets 122 are provided.

[0071] Example 3

[0072] This embodiment provides a reinforcement kit, which includes the proximal anastomotic reinforcement component in embodiment 1 or embodiment 2, and the distal anastomotic reinforcement component. Figure 9-10 As shown, the distal reinforcement assembly includes a distal reinforcement sheet 21 and a distal fixing assembly 22, and the distal fixing assembly 22 includes an internal fixing member 221 and an external fixing member 222, and the internal fixing member 221 and the external fixing member 222 are detachably connected. The distal reinforcement sheet 21 is clamped between the internal fixing member 221 and the external fixing member 222. The distal reinforcement sheet 21 is in large-area surface contact with the internal fixing member 221 and the external fixing member 222, thereby improving the support strength of the distal reinforcement assembly on the distal reinforcement sheet 21 and reducing the possibility of warping of the distal reinforcement sheet 21 when it moves in the body. The internal fixing member 221 is used for detachably connecting the central axis 5 of the circular stapler.

[0073] Specifically, the distal reinforcing sheet 21, the internal fixing member 221 and the external fixing member 222 all have a through hole for accommodating the central axis 5 of the circular stapler, and the axes of the through holes of the three are collinear, so that the supporting force provided by the distal reinforcing assembly is evenly distributed in an annular shape on the distal reinforcing sheet 21. In this embodiment, the distal reinforcing sheet 21, the internal fixing member 221 and the external fixing member 222 are all annular.

[0074] Specifically, the inner fixing member 221 and the outer fixing member 222 do not exceed the outer edge of the distal reinforcing sheet 21 in the radial direction of the three through holes, so as to leave contact space between the distal reinforcing sheet 21 and the staples 6 and the annular knife 32 in the circular stapler. In this embodiment, the outer diameters of the inner fixing member 221 and the outer fixing member 222 are both smaller than the outer diameter of the distal reinforcing sheet 21.

[0075] Specifically, the diameter of the through hole of the external fixing member 222 and the diameter of the through hole of the distal reinforcing sheet 21 are both greater than or equal to the diameter of the through hole of the internal fixing member 221, so as to prevent the external fixing member 222 and the distal reinforcing sheet 21 from interfering with the connection between the central axis 5 of the circular stapler and the internal fixing member 221. In this embodiment, the inner diameters of the external fixing member 222 and the distal reinforcing sheet 21 are greater than or equal to the inner diameter of the internal fixing member 221.

[0076] Specifically, the internal fixing member 221 is an elastic fixing member, which is fixed on the central axis 5 of the circular stapler by friction. In this embodiment, the internal fixing member 221 is a medical silicone fixing member.

[0077] Specifically, the distal reinforcement assembly also includes a fastening piece 223, a plurality of fastening pieces 223 are provided, and all the fastening pieces 223 are distributed around the axis of the internal fixing piece 221. The fastening piece 223 passes through the external fixing piece 222 and the distal reinforcement plate 21, and is inserted into the internal fixing piece, and is engaged with the internal fixing piece, so as to tightly connect the distal reinforcement plate 21, the internal fixing piece 221 and the external fixing piece 222 together.

[0078] Specifically, the distal reinforcement sheet 21 is a degradable biological reinforcement sheet. The material of the degradable biological reinforcement sheet includes completely degradable and absorbable biological materials from animal sources and / or completely degradable and absorbable polymer biological materials and / or completely degradable and absorbable biological materials synthesized from animal sources and polymers. The degradable biological reinforcement sheet can provide sufficient mechanical tension during the tissue healing process to prevent the staplers 6 from damaging the surrounding tissues. After the tissue is healed, the degradable biomaterials will degrade on their own and will not cause harmful effects to the human body.

[0079] Specifically, the thickness of the distal reinforcing sheet 21 is less than or equal to 0.3 mm, so as to ensure that the annular knife 32 of the circular stapler can smoothly cut the distal reinforcing sheet 21 .

[0080] Example 4

[0081] like Figure 11-12As shown, this embodiment provides a reinforcement kit, and the difference between this embodiment and embodiment 3 is that a plurality of fastening strips 2211 are arranged on the inner side of the inner fixing member 221 in this embodiment, and all the fastening strips 2211 are parallel to the axis of the inner fixing member 221 and are distributed around the axis of the inner fixing member 221 to increase the elastic deformation of the inner fixing member 221 and widen the size range of the central axis 5 to which the inner fixing member 221 can be connected. In this embodiment, all the elastic fastening strips 2211 are evenly distributed around the axis of the inner fixing member 221.

[0082] Specifically, the distal reinforcing sheet 21 has at least one second incision 211, and the second incision 211 divides the distal reinforcing sheet 21 along the axial direction of the distal reinforcing sheet 21, and the two cut surfaces at a single second incision 211 can fit each other. When there are multiple second incisions 211, all second incisions 211 divide the distal reinforcing sheet 21 into multiple parts distributed around the axis of the distal reinforcing sheet 21. The setting of the second incision 211 allows the distal reinforcing sheet 21 to ensure that the anastomosis can have a certain amount of expansion under the action of the tension of the tissue on the basis of reinforcing the tissue, thereby facilitating the removal of the circular stapler from the anastomosis, reducing the risk of tearing the anastomosis during the removal of the circular stapler from the anastomosis, thereby improving the success rate of the operation. In addition, the central axis 5 of the circular stapler can enter and exit the distal reinforcing sheet 21 from the second incision 211, so as to realize the disassembly and assembly of the distal reinforcing sheet 21 on the existing circular stapler without changing the structure of the existing circular stapler.

[0083] Specifically, the inner fixing member 221 has at least one third cutout 2212, and the third cutout 2212 divides the inner fixing member 221 along the axis direction of the inner fixing member 221. When there are multiple third cutouts 2212, all the third cutouts 2212 divide the inner fixing member 221 into multiple parts distributed around the axis of the inner fixing member 221.

[0084] The external fixing member 222 has at least one fourth cutout 2221, and the fourth cutout 2221 divides the external fixing member 222 along the axis direction of the external fixing member 222. When there are multiple fourth cutouts 2221, all the fourth cutouts 2221 divide the external fixing member 222 into multiple parts distributed around the axis of the external fixing member 222, and two adjacent parts of the internal fixing member 221 can be detachably connected.

[0085] The central axis 5 of the circular stapler can enter and exit the inner fixing member 221 and the outer fixing member 222 through the third incision 2212 and the fourth incision 2221, so as to realize the disassembly and assembly of the distal fixing assembly 22 on the existing circular stapler without changing the structure of the existing circular stapler.

[0086] It should be noted that, by connecting every two adjacent parts of the inner fixing member 221 to the same part of the outer fixing member 222 through the buckle 223, the parts of the inner fixing member 221 and the parts of the outer fixing member 222 can be connected into a ring shape.

[0087] Specifically, in this embodiment, the two cross-sections at the single third incision 2212 can fit together, and the two cross-sections at the single fourth incision 2221 can fit together, so that the inner fixing member 221 and the outer fixing member 222 are both complete rings, further improving the uniformity of the supporting force provided by the distal reinforcement assembly in the circumferential direction of the distal reinforcement sheet 21.

[0088] Specifically, the distal reinforcing sheet 21 has a plurality of second incisions 211, the inner fixing member 221 has a plurality of third incisions 2212, and the outer fixing member 222 has a plurality of fourth incisions 2221. In this embodiment, the number of the second incisions 211, the third incisions 2212, and the fourth incisions 2221 are all two.

[0089] Specifically, each part of the internal fixing member 221 is provided with a second plug-in portion 2213 and a second plug-in groove 2214. Two adjacent parts of the internal fixing member 221 are connected together by plugging and fitting the second plug-in portion 2213 and the second plug-in groove 2214 to improve the connection strength between the parts of the internal fixing member 221 and ensure that the parts of the internal fixing member 221 can be firmly clamped on the central axis 5 of the circular anastomosis device.

[0090] Specifically, in this embodiment, the distal reinforcing sheet 21, the internal fixing member 221, and the external fixing member 222 are all composed of two parts, and the two parts of the distal reinforcing sheet 21 correspond one-to-one to the two parts of the internal fixing member 221, and the two parts of the distal reinforcing sheet 21 also correspond one-to-one to the two parts of the external fixing member 222. Each part of the distal reinforcing sheet 21 is fixedly connected to its corresponding part of the internal fixing member 221 and its corresponding part of the external fixing member 222, so as to facilitate the rapid disassembly and assembly of the distal anastomotic stoma reinforcement assembly on the central axis of the circular stapler. In this embodiment, each part of the distal reinforcing sheet 21 is fixedly connected to its corresponding part of the internal fixing member 221 and its corresponding part of the external fixing member 222 through an adhesive layer.

[0091] Example 5

[0092] like Figure 13-16 As shown, this embodiment provides a circular stapler, which includes the reinforcement kit described in Example 3 or Example 4, a nail barrel 3, a nail support 4 and a central axis 5;

[0093] A nail magazine 31 and an annular knife 32 are fixed in the nail barrel 3, a nail anvil 41 and a knife anvil 42 are fixed in the nail anvil 4, a central shaft 5 is fixedly connected to the nail anvil 4, and the central shaft 5 is fixedly connected to the nail barrel 3. One end of the nail barrel 3 away from the nail anvil 4 is connected to a firing handle for controlling the relative movement of the nail barrel 3 and the nail anvil 4.

[0094] The end surface portion 111 is attached to the end surface of the nail magazine 31, and at most one protrusion 113 is embedded in the magazine hole 311 of each single nail in the nail magazine 31. The cylindrical connecting portion 112 is located inside the annular knife 32 and is detachably connected to the nail barrel 3 through the proximal fixing assembly 12.

[0095] The inner fixing member 221 is detachably connected to the central shaft 5, and the distal reinforcing sheet 21 is in contact with the end surface of the nail anvil 41. When the annular knife 32 abuts against the knife anvil 42, the distal fixing assembly 22 is located inside the annular knife 32.

[0096] In this embodiment, a protrusion 113 is embedded in the magazine hole 311 of each single nail in the nail magazine 31.

[0097] Specifically, the distance between the outer edge of the inner fixing member 221 and the inner wall of the anvil 42 is greater than or equal to 2 mm, and the distance between the outer edge of the outer fixing member 222 and the inner wall of the anvil 42 is greater than or equal to 2 mm, so as to prevent the inner fixing member 221 and the outer fixing member 222 from hindering the cutting of the annular knife 32. In this embodiment, the difference between the outer diameter of the inner fixing member 221 and the inner diameter of the anvil 42 is greater than or equal to 2 mm, and the difference between the outer diameter of the outer fixing member 222 and the inner diameter of the anvil 42 is greater than or equal to 2 mm.

[0098] Specifically, the distance between the outer wall of the cylindrical connection part 112 and the inner wall of the annular knife 32 is greater than or equal to 2 mm, so as to facilitate the installation of the tension ring described in Example 1, or when the proximal anastomotic reinforcement component 1 in the reinforcement kit is the proximal anastomotic reinforcement component 1 described in Example 2, a gap is provided between the cylindrical connection part 112 and the annular knife 32 to reduce the interference of the cylindrical connection part 112 on the movement of the annular knife 32. In this embodiment, the difference between the outer diameter of the cylindrical connection part 112 and the inner diameter of the annular knife 32 is greater than or equal to 2 mm.

[0099] This embodiment can be used for circular hemorrhoidal mucosal resection, C-type hemorrhoidal mucosal resection, and selective resection of hemorrhoidal mucosa.

[0100] Example 6

[0101] like Figure 17-18As shown, this embodiment provides a circular stapler, and the difference between this embodiment and embodiment 5 is that the central axis 5 is detachably connected to the nail tube 3. This embodiment can be used for esophageal anastomosis, such as end-to-side anastomosis between a tubular stomach and an esophagus, a colon-esophagus and an esophagus; stomach-to-esophagus anastomosis, such as end-to-side anastomosis of the stomach and esophagus after proximal gastrectomy; jejunal-to-esophageal anastomosis, such as end-to-side anastomosis of the jejunal esophagus after total gastrectomy; stomach-to-jejunal anastomosis, such as end-to-side anastomosis of the stomach and jejunum after distal gastrectomy; ileocolic anastomosis, such as end-to-end anastomosis of the colon and ileum after ascending colon resection; such as colon anastomosis, end-to-end anastomosis of colon to colon after ascending colon and transverse colon resection; rectal anastomosis, such as end-to-end anastomosis of rectum to colorectum after sigmoid colon and rectum resection; anorectal anastomosis, such as resection and anastomosis of rectal prolapse, rectocele, hemorrhoids above grade III, etc.

[0102] The above description is only the preferred embodiment of the utility model, and is not intended to limit the utility model. For those skilled in the art, the utility model can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the utility model shall be included in the protection scope of the utility model.

Claims

1. A proximal anastomotic reinforcement component, characterized in that: The invention comprises a proximal reinforcing sheet (11) and a proximal fixing assembly (12), wherein the proximal reinforcing sheet (11) comprises an end face portion (111) and a cylindrical connecting portion (112), wherein the end face portion (111) is a circular ring sheet, wherein the top end of the cylindrical connecting portion (112) is fixed to the bottom surface of the end face portion (111), and the inner side surface of the cylindrical connecting portion (112) is aligned with the inner annular edge of the end face portion (111); the bottom surface of the end face portion (111) has a plurality of protrusions (113); the protrusions (113) are used to be embedded in a magazine hole (311) of a single nail in a nail magazine (31) of a circular stapler; and the proximal fixing assembly (12) is used to detachably connect the cylindrical connecting portion (112) and the nail barrel (3) of the circular stapler.

2. The proximal anastomotic reinforcement assembly according to claim 1, characterized in that: The proximal reinforcing sheet (11) has at least one first cut (114), and the first cut (114) divides the end face portion (111) and the cylindrical connecting portion (112) along the axial direction of the cylindrical connecting portion (112), and the two cut surfaces at a single first cut (114) can fit each other; when there are multiple first cuts (114), all the first cuts (114) divide the proximal reinforcing sheet (11) into multiple parts distributed around the axial line of the cylindrical connecting portion (112); each part of the proximal reinforcing sheet (11) is connected to the proximal fixing assembly (12).

3. The proximal anastomotic reinforcement assembly according to claim 2, characterized in that: The proximal fixing component (12) is an annular structure with a single opening, or the proximal fixing component (12) is composed of a plurality of components distributed around the axis of the cylindrical connecting portion (112).

4. The proximal anastomotic reinforcement assembly according to claim 3, characterized in that: The proximal fixing assembly (12) comprises a tensioning ring, which comprises a plurality of arc-shaped members (121), each arc-shaped member (121) being provided with a first plug-in portion (1211) and a first plug-in groove (1212), all the arc-shaped members (121) being distributed around the axis of the cylindrical connecting portion (112), and two adjacent arc-shaped members (121) being connected together by plugging and fitting the first plug-in portion (1211) and the first plug-in groove (1212); the cylindrical connecting portion (112) is fixedly connected to the tensioning ring, the tensioning ring is tensioned on the inner side of the nail barrel (3) of the circular stapler, and the tensioning ring is located on the inner side of the annular knife (32) of the circular stapler.

5. The proximal anastomotic reinforcement assembly according to claim 3, characterized in that: The proximal fixing assembly (12) comprises a bracket (122) and a buckle (123), wherein a plurality of brackets (122) are provided, and each bracket (122) is fixedly connected to the cylindrical connecting portion (112) and the circular stapler; the cylindrical connecting portion (112) is provided with a plurality of first buckle grooves distributed around the axis of the cylindrical connecting portion (112), and a buckle (123) passing through the top end of the bracket (122) is buckled in each of the first buckle grooves; the circular stapler is provided with a plurality of second buckle grooves distributed around the axis of the circular stapler, and a buckle (123) passing through the bottom end of the bracket (122) is buckled in each of the second buckle grooves.

6. The proximal anastomotic reinforcement assembly according to any one of claims 1 to 5, characterized in that: A groove (115) is provided at the top of the end surface portion (111), and each protrusion (113) has a groove (115) inside.

7. The proximal anastomotic reinforcement assembly according to claim 6, characterized in that: The proximal reinforcement sheet (11) is a degradable biological reinforcement sheet, and the thickness of the end surface portion (111) is less than or equal to 0.3 mm.

8. A reinforcement kit, characterized in that: The invention comprises a proximal anastomotic reinforcement component (1) and a distal anastomotic reinforcement component (2) as described in any one of claims 1 to 7; the distal anastomotic reinforcement component (2) comprises a distal reinforcement sheet (21) and a distal fixing component (22); the distal fixing component (22) comprises an inner fixing member (221) and an outer fixing member (222); the inner fixing member (221) and the outer fixing member (222) are detachably connected; the distal reinforcement sheet (21) is clamped between the inner fixing member (221) and the outer fixing member (222); the distal reinforcement sheet (21 ), the internal fixing member (221) and the external fixing member (222) all have a through hole for accommodating the central axis (5) of the circular stapler, and the axes of the through holes of the three are collinear. In the radial direction of the three through holes, the internal fixing member (221) and the external fixing member (222) do not exceed the outer edge of the distal reinforcing sheet (21), and the through hole diameter of the external fixing member (222) and the through hole diameter of the distal reinforcing sheet (21) are both greater than or equal to the through hole diameter of the internal fixing member (221); the internal fixing member (221) is used for detachably connecting to the central axis (5) of the circular stapler.

9. The reinforcement kit according to claim 8, characterized in that: The internal fixing member (221) is an elastic fixing member, which is fixed on the central axis (5) of the circular stapler by means of friction.

10. The reinforcement kit according to claim 9, characterized in that: A plurality of fastening strips (2211) are arranged on the inner side of the inner fixing member (221), and all the fastening strips (2211) are parallel to the axis of the inner fixing member (221) and are distributed around the axis of the inner fixing member (221).

11. The reinforcement kit according to claim 9 or 10, characterized in that: The distal reinforcing sheet (21) has at least one second incision (211), the second incision (211) divides the distal reinforcing sheet (21) along the axial direction of the distal reinforcing sheet (21), and the two cut surfaces at a single second incision (211) can fit each other; when there are multiple second incisions (211), all the second incisions (211) divide the distal reinforcing sheet (21) into multiple parts distributed around the axial direction of the distal reinforcing sheet (21).

12. The reinforcement kit according to claim 11, characterized in that: The inner fixing member (221) has at least one third cutout (2212), and the third cutout (2212) divides the inner fixing member (221) along the axis direction of the inner fixing member (221); when there are multiple third cutouts (2212), all the third cutouts (2212) divide the inner fixing member (221) into multiple parts distributed around the axis of the inner fixing member (221), and two adjacent parts of the inner fixing member (221) are detachably connected; The external fixing member (222) has at least one fourth cutout (2221), and the fourth cutout (2221) divides the external fixing member (222) along the axis direction of the external fixing member (222); when there are multiple fourth cutouts (2221), all the fourth cutouts (2221) divide the external fixing member (222) into multiple parts distributed around the axis of the external fixing member (222).

13. The reinforcement kit according to claim 12, characterized in that: The distal reinforcing plate (21) has a plurality of second cutouts (211), the internal fixing member (221) has a plurality of third cutouts (2212), and the external fixing member (222) has a plurality of fourth cutouts (2221); each part of the internal fixing member (221) is provided with a second plug-in portion (2213) and a second plug-in groove (2214), and two adjacent parts of the internal fixing member (221) are connected together by plugging and matching the second plug-in portion (2213) with the second plug-in groove (2214).

14. The reinforcement kit according to claim 9 or 10, characterized in that: The distal reinforcement component also includes a fastening piece (223), a plurality of fastening pieces (223) are provided, and all the fastening pieces (223) are distributed around the axis of the internal fixing piece (221); the fastening piece (223) passes through the external fixing piece (222) and the distal reinforcement sheet (21), and is inserted into the internal fixing sheet to be snap-connected with the internal fixing sheet.

15. The reinforcement kit according to claim 9 or 10, characterized in that: The distal reinforcement sheet (21) is a degradable biological reinforcement sheet; the thickness of the distal reinforcement sheet (21) is less than or equal to 0.3 mm.

16. A circular stapler, characterized in that: It comprises a reinforcement kit as claimed in any one of claims 8 to 15, a nail barrel (3), a nail support (4) and a central shaft (5); A nail magazine (31) and an annular knife (32) are fixed in the nail barrel (3), a nail anvil (41) and a knife anvil (42) are fixed in the nail anvil (4), a central shaft (5) is fixedly connected to the nail anvil (4), and the central shaft (5) is fixedly connected or detachably connected to the nail barrel (3); the end surface portion (111) is in contact with the end surface of the nail magazine (31), and at most one protrusion (113) is embedded in the magazine hole (311) of each single nail in the nail magazine (31); the cylindrical connecting portion (112) is located on the inner side of the annular knife (32), and is detachably connected to the nail barrel (3) through a proximal fixing component (12); The inner fixing member (221) is detachably connected to the central axis (5), and the distal reinforcing sheet (21) is in contact with the end surface of the nail anvil (41); when the annular knife (32) and the knife anvil (42) are in contact, the distal fixing component (22) is located inside the annular knife (32).

17. The circular stapler according to claim 16, characterized in that: In the radial direction of the anvil (42), the distance between the outer edge of the inner fixing member (221) and the inner edge of the anvil (42) is greater than or equal to 2 mm, and the distance between the outer edge of the outer fixing member (222) and the inner edge of the anvil (42) is greater than or equal to 2 mm.

18. The circular stapler according to claim 16, characterized in that: The distance between the outer wall of the cylindrical connecting portion (112) and the inner wall of the annular knife (32) is greater than or equal to 2 mm.

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