Anastomotic stoma reinforcing repair piece
Technical Field
The invention relates to the technical field of medical appliances, in particular to an anastomotic stoma reinforcing repair piece for a tubular anastomat.
Background
The surgical reinforcing device has very wide application in surgical operations because it can cut and seal tissue and organs in a patient at the same time rapidly, and reduces the risk of such surgical procedures to a great extent and shortens the surgical time compared with the prior surgical knife/scissors. The cutting anastomosis of the tubular anastomat comprises two parts, wherein one part is a nail anvil part with an umbrella-shaped or mushroom-shaped shape, and the other part is a nail bin part of the anastomat. The nail bin part is provided with an annular nail bin and comprises more than two nail wires. The cartridge portion is further provided with an annular knife for cutting tissue. The tubular anastomat can form annular anastomotic threads on tissues and cut the tissues by using an annular knife to form circular anastomoses. The device can be used for conveniently performing end-to-end, end-to-side and side-to-side anastomosis of a lumen organ, and is commonly used for esophagus, intestine or gastrointestinal operation.
In some procedures, it is feasible to use bare staples directly, i.e., staples that are in direct contact with the patient's tissue. Because the patient's intact tissue itself prevents the staples from being detached from the combination and compensates for the slit before healing. However, for other procedures, the tissue to be stapled by the patient is too fragile for pathological or physiological reasons, making it difficult to fix the staples in the corresponding positions. Furthermore, when using a stapler, bleeding and weeping problems around the staples also need to be addressed.
One known protective measure is to use reinforcing or stiffening materials which work on the principle that a layer of absorbable stiffening material is assembled on both the staple cartridge and anvil surface of the stapler, and the material is secured to the stoma while cutting stapling is completed, protecting the delicate tissue from being torn by the staples, closing the gap between the bare staple and the tissue or vessel, thereby strengthening the stoma and reducing the risk of complications such as bleeding, weeping, etc. of the stoma. For the tubular anastomat, an anastomotic stoma reinforcing sheet with an annular or wafer-shaped structure is adopted.
When using a reinforced sheet with a stoma, the tubular anastomat will enter the body or tissue through the tissue incision, at which time friction or collision between the reinforced sheet and the tissue cutting edge is easy, which friction or collision may cause deformation or even wrinkling of the reinforced sheet and even may cause detachment, which is very detrimental to the anastomosis procedure, which may lead to a difficult effective stapling of the staples. During the surgical procedure, the formation of a purse or the adjustment of the position of the clamped tissue may also cause deformation or wrinkling of the reinforcement patch, which may make it difficult to effectively staple the staples.
Disclosure of Invention
The anastomotic stoma reinforcing repair piece is matched with the anastomotic stoma reinforcing repair piece of the prior tubular anastomat nail bin assembly or matched with the tubular anastomat, and can prevent the anastomotic stoma reinforcing repair piece of the nail anvil assembly from deforming, wrinkling or falling off. Thereby preventing bleeding and leakage of the anastomotic stoma caused by deformation, wrinkling or falling of the anastomotic stoma reinforcing repair sheet of the nail anvil assembly. The invention provides a anastomotic stoma reinforcement repair kit, which comprises an anastomotic stoma reinforcement repair piece for a nail anvil assembly and a nail bin assembly, wherein the anastomotic stoma reinforcement repair piece can provide sufficient strength for compensating thickness of a tissue to be treated, prevent anastomotic stoma from tearing, and prevent bleeding and leakage of the anastomotic stoma.
To solve one or more of the above problems, the present invention provides a stoma-strengthening repair for an anvil assembly of a tubular stapler, which is characterized in that: the reinforcement repair includes a bottom portion and a sidewall portion; the bottom is round, and an opening is arranged at the center of the bottom; the side wall part is connected with the bottom part, and the side wall part inclines towards the center direction of the bottom part, so that the reinforcing repair piece can be sleeved on the nail anvil component of the tubular anastomat. The opening at the bottom is used for passing the connecting rod of the nail anvil assembly. The side wall part is connected with the edge of the bottom part, and inclines from the edge to the center direction of the bottom part to form a tapered structure in the upward direction from the bottom surface. The tapered structure of the side wall is combined with the bottom to form a sleeving space matched with the nail anvil assembly, so that the nail anvil assembly is sleeved. The relative fixing mode can eliminate the relative movement between the anastomotic stoma reinforcement repair piece and the nail anvil assembly, so that the nail anvil assembly is stably fixed on the nail anvil assembly. Even when friction or collision occurs during the entering of human body or tissues, wrinkles are not generated and the human body or tissues are not separated.
The sidewall portion of the reinforcement repair has one or more cutouts. The side wall part and the bottom part form a sleeving space with a tapered structure, and the bottom part is used for covering the anvil surface of the anvil assembly, so that the opening size of the sleeving space is smaller than the size of the anvil surface of the anvil assembly. The one or more slits are flared when the anastomosis reinforcement repair is mounted to the anvil assembly, thereby increasing the flared dimension of the openings of the sleeve-like structure, allowing the reinforcement repair to be more easily assembled to the anvil assembly. When the anastomotic stoma reinforcement repair is assembled, the reinforcement repair is sleeved on the nail anvil component of the anastomat due to the fact that the reinforcement repair has certain strength and the one or more cuts are restored to the original state. The shape of the incision may be slit, wedge, rectangular or curved.
The external profile of the reinforcement patch is substantially frustoconical or frustoconical. The anvil assembly typically has an external profile similar to a cone, table, hemisphere or table or a combination thereof. The reinforcing repair piece is sleeved on the nail anvil component by wrapping the side surface of the nail anvil component, so that the external integral outline of the reinforcing repair piece is in a truncated cone shape or a spherical table shape, and the top end of the reinforcing repair piece is open and is used for being sleeved with the nail anvil component.
The anastomotic stoma reinforcing repair is integrally formed. The integral forming is more beneficial to the side wall part and the bottom part of the anastomotic stoma reinforcement repair piece and the integral shaping thereof, so that the sleeve joint to the nail anvil assembly is more stable.
The reinforcement patch or the reinforcement repair comprises a degradable material, preferably a degradable polymeric material or a degradable biological material. The material of the reinforcing repair patch is non-immunogenic and in-vivo degradable, has a three-dimensional reticular porous structure, can reinforce the anastomat orifice, and is matched with the anastomat for use, such as a high polymer material or a biological material. The degradable high molecular material can be polylactic acid, polyglycolide, polyglycolic acid, copolymer of glycol acid and lactic acid, copolymer of lactic acid and caprolactone, copolymer of glycol acid and caprolactone, polycaprolactone, polydioxanone or mixture thereof. The degradable biological material comprises an extracellular matrix material. The extracellular matrix material can be degraded and absorbed in vivo by immunogen removal treatment. The extracellular matrix contains non-crosslinked collagen fiber, mucopolysaccharide, growth factor and glycoprotein, and the degradation product is absorbed by tissue to facilitate tissue reconstruction. The reinforced patch comprises an immunogen-removing treated biological tissue, preferably a decellularized small intestine submucosa matrix material. The biological tissue subjected to the immunogen removal treatment can be a tissue envelope or an inner membrane. Further, a pericardium or small intestine submucosa, preferably a decellularized small intestine submucosa matrix material such as a porcine or bovine small intestine submucosa material matrix material, may be selected.
The invention also provides an anastomotic stoma reinforcement repair kit, which is characterized in that: the anastomotic stoma reinforcement repair kit is used for a tubular anastomat and comprises the anastomotic stoma reinforcement repair piece and the nail bin anastomotic stoma reinforcement repair piece, wherein the nail bin anastomotic stoma reinforcement repair piece is used for a nail bin assembly, and the nail bin anastomotic stoma reinforcement repair piece can cover the surface of a nail bin of the nail bin assembly.
The invention also provides a tubular anastomat kit, which is characterized in that: the tubular anastomat kit comprises the tubular anastomat and the anastomotic stoma reinforcing and repairing kit.
The anastomotic stoma reinforcing repair piece of the tubular anastomat anvil component can compensate the thickness of tissues and/or provide sufficient strength for tissues to be treated no matter the anastomotic stoma reinforcing repair piece is used singly or matched with the anastomotic stoma reinforcing repair piece of the existing tubular anastomat cartridge component; preventing the anastomotic stoma from tearing; preventing bleeding and leakage of anastomotic stoma. In addition, the anastomotic stoma reinforcement repair piece of the tubular anastomat anvil assembly can also prevent the anastomotic stoma reinforcement repair piece of the anvil assembly from deforming, wrinkling or falling off. Thereby preventing bleeding and leakage of the anastomotic stoma caused by deformation, wrinkling or falling of the anastomotic stoma reinforcing repair sheet of the nail anvil assembly. According to the invention, the tapered structure of the reinforcing repair piece is sleeved on the outer surface of the nail anvil assembly, so that the reinforcing repair piece and the nail anvil assembly are stably fixed by adopting a special structure under the condition that other materials (such as binding wires or adhesives) are not added, the risk of inflammation is reduced, and the application range and the use safety of the product are greatly improved.
Drawings
FIG. 1A is a schematic view of a reinforced prosthesis according to a first embodiment of the present invention;
FIG. 1B is a schematic top view of a reinforced prosthesis according to a first embodiment of the present invention;
FIG. 2A is a schematic view of a reinforced prosthesis according to a second embodiment of the present invention;
FIG. 2B is a schematic view of a reinforcement repair according to a second embodiment of the present invention assembled to an anvil assembly;
FIG. 3 is a schematic view of a reinforced prosthesis according to a third embodiment of the present invention;
FIG. 4 is a schematic view of a reinforced prosthesis according to a fourth embodiment of the present invention;
FIG. 5 is a schematic illustration of the outer contour of a reinforced prosthesis according to one embodiment of the present invention;
FIG. 6 is a schematic illustration of the outer contour of a reinforced prosthesis according to another embodiment of the present invention;
FIG. 7 is a schematic view of a prior art tubular stapler anvil assembly;
fig. 8 is a schematic view of a prior art tubular stapler cartridge assembly.
Detailed Description
FIG. 7 is a schematic view of an anvil assembly of a tubular stapler; FIG. 8 is a schematic view of a tubular stapler cartridge assembly. The nail anvil assembly comprises a nail propping seat 71 and a connecting rod 72, wherein a nail anvil surface is arranged on the nail propping seat 71 and used for forming the anastomotic nail subjected to firing so as to realize nailing. The cartridge assembly includes a tubular body 81, an annular cartridge 82, an annular knife 83, and a fixed rod 84. The anvil assembly connecting rod 72 and the cartridge assembly securing rod 84 are cooperatively connected.
The anastomotic stoma reinforcement repair of the embodiments of the present invention is mounted on an anvil assembly to which an existing anastomotic stoma reinforcement repair, such as a circular reinforcement repair with a central hole, may be mounted. The connecting rod 72 of the anvil assembly is cooperatively connected with the cartridge assembly securing rod 84 to secure the tissue to be resected. By firing the stapler, the annular knife 83 and staples in the cartridge assembly 82 are moved axially, completing the cutting of the tissue and the closing of the stoma. At this time, the anastomotic stoma is closed by the anastomotic nail, and the reinforcing repair sheet is fixed at the anastomotic stoma.
FIG. 1A is a schematic view of a reinforced prosthesis according to a first embodiment of the present invention; fig. 1B is a schematic top view of a reinforced prosthesis according to a first embodiment of the present invention. The reinforcement patch 10 includes a bottom portion 11 and a sidewall portion 12. The bottom 11 is substantially circular and is provided with a through hole 13 in the centre. The side wall 12 is connected with the bottom 11 at the edge, the side wall 12 is inclined from the edge to the center direction of the bottom 11 to form a tapered structure from the bottom to the upper direction, and the tapered structure formed by the side wall is combined with the bottom to enable the reinforcement repair member 10 to be sleeved on the nail anvil assembly of the tubular anastomat. The bottom 11 is substantially fitted to the anvil surface of the anvil abutment and the side wall 12 is substantially fitted to the side of the abutment, forming a stable sleeve-joint relationship. Such a connection reduces or eliminates relative movement between the stoma-strengthening repair 10 and the anvil, allowing it to be stably secured to the anvil assembly.
The sidewall portion 12 of the reinforcement patch 10 has a wedge-shaped cutout 14. Because the structure formed by the side wall part and the bottom part is provided with a sleeve-shaped structure with a tapered structure, the diameter of the anvil surface of the anvil assembly is larger than the opening size of the sleeve-shaped structure. The wedge-shaped incision 14 opens upon installation of the stoma reinforcement prosthesis to the anvil assembly, thereby increasing the open size of the opening of the sleeve-like structure, thereby enabling the reinforcement prosthesis to be more easily assembled to the anvil assembly. When the anastomotic stoma reinforcing repair piece is assembled, the incision is restored due to the self strength of the reinforcing repair piece, so that the reinforcing repair piece can be sleeved on the anastomotic stoma reinforcing repair assembly.
The reinforcement repair material is a degradable material, including a polymer material or a biological material. These materials can be degraded in vivo. The polymer material can be directly and integrally plastic. The biological material may be made using an extracellular matrix that has been subjected to an immunogen removal treatment, for example, using an decellularized intestinal submucosa matrix material. The small intestine submucosa is preferably a porcine or bovine small intestine submucosa matrix. Because the anvil assembly generally has a shape resembling a cone, a truncated cone, a hemisphere or a sphere or a combination thereof, the reinforcement patch is sleeved on the anvil assembly by wrapping around the structure adjacent the anvil surface. Thus, by the shaping process, the external overall profile of the reinforcement repair is given a frustoconical or bulbous shape, the top of which is open for socket engagement with the anvil assembly. The shaping treatment may be a drying treatment, for example, vacuum drying, air drying, freeze drying, or the like. The formed anastomotic stoma reinforcing repair piece has certain strength, the incision can be opened when the anastomotic stoma reinforcing repair piece is assembled on the nail anvil assembly, and the incision is restored to the original shape after the nail anvil surface enters an open space surrounded by the side wall part and the bottom surface, so that the reinforcing repair piece can be stably sheathed on the surface of the nail anvil assembly. When the anastomat is used, after the nail anvil reinforcing repair piece is assembled in the mode, the nail bin assembly anastomotic stoma reinforcing repair piece is assembled; tissue cutting is then performed.
FIG. 2A is a schematic view of a reinforced prosthesis according to a second embodiment of the present invention; FIG. 2B is a schematic view of a reinforcement repair according to a second embodiment of the present invention assembled to an anvil assembly. The reinforcement patch 20 includes a bottom portion 21 and a sidewall portion 22. The bottom 21 is substantially circular and is provided with a through hole 23 in the centre. The side wall 22 is connected with the bottom 21 at the edge, the side wall 22 is inclined from the edge to the center direction of the bottom 21 to form a tapered structure from the bottom to the upper direction, and the tapered structure formed by the side wall is combined with the bottom to enable the reinforcement repair piece 20 to be sleeved on the nail anvil assembly of the tubular anastomat. The bottom 21 is substantially engaged with the anvil surface of the anvil abutment and the sidewall 22 is substantially engaged with the side of the abutment, forming a stable sleeved relationship. Such a connection reduces or eliminates relative movement between the stoma-strengthening repair 20 and the anvil to allow it to be stably secured to the anvil assembly.
The sidewall portion 22 of the reinforcement patch 20 has two wedge-shaped cutouts 24. Because the structure formed by the side wall part and the bottom part is provided with a sleeve-shaped structure with a tapered structure, the diameter of the anvil surface of the anvil assembly is larger than the opening size of the sleeve-shaped structure. The wedge-shaped incision 24 can be opened when the anastomosis reinforcement prosthesis is mounted to the anvil assembly, thereby increasing the opening size of the sleeve-like structure opening, and thus allowing the reinforcement prosthesis to be more easily assembled to the anvil assembly. When the anastomotic stoma reinforcing repair piece is assembled, the incision is restored due to the self strength of the reinforcing repair piece, so that the reinforcing repair piece can be sleeved on the anastomotic stoma reinforcing repair assembly.
The reinforcement repair material is a degradable material, including a polymer material or a biological material. These materials can be degraded in vivo. The biological material may be made using an extracellular matrix that has been subjected to an immunogen removal treatment, for example, using an decellularized intestinal submucosa matrix material. The small intestine submucosa is preferably a porcine or bovine small intestine submucosa matrix.
Fig. 3 is a schematic view of a reinforced prosthesis according to a third embodiment of the present invention. The reinforcement repair 30 includes a bottom portion 31 and a sidewall portion 32. The bottom 31 is substantially circular and is provided with a through hole 33 in the centre. The side wall 32 is connected with the bottom 31, the side wall 32 is inclined towards the center of the bottom 31 to form a tapered structure upwards from the bottom, and the tapered structure formed by the side wall is combined with the bottom to enable the reinforcement repair 30 to be sleeved on the nail anvil assembly of the tubular anastomat. The bottom 31 is substantially engaged with the anvil surface of the anvil abutment and the sidewall 32 is substantially engaged with the side of the abutment, forming a stable sleeved relationship. Such a connection reduces or eliminates relative movement between the stoma-strengthening repair 30 and the anvil to allow it to be stably secured to the anvil assembly.
The sidewall portion 32 of the reinforcement repair 30 has three curved cuts 34. Because the structure formed by the side wall part and the bottom part is provided with a sleeve-shaped structure with a tapered structure, the diameter of the anvil surface of the anvil assembly is larger than the opening size of the sleeve-shaped structure. The curved slits 34 open upon installation of the anastomosis reinforcement repair to the anvil assembly, thereby increasing the open size of the openings of the sleeve-like structure, thereby enabling the reinforcement repair to be more easily assembled to the anvil assembly. When the anastomotic stoma reinforcing repair piece is assembled, the incision is restored due to the self strength of the reinforcing repair piece, so that the reinforcing repair piece can be sleeved on the anastomotic stoma reinforcing repair assembly.
Fig. 4 is a top view of a reinforced prosthesis according to a fourth embodiment of the present invention. The reinforcement repair 40 includes a bottom portion 41 and a sidewall portion 42. The bottom 41 is substantially circular and is centrally provided with a central cutout 43. The connecting rod 72 passes through the central cutout 43 when the reinforcement repair 40 is mounted to the anvil assembly. The side wall portion 42 is connected with the bottom portion 41, the side wall portion 42 is inclined towards the center direction of the bottom portion 41 to form a tapered structure, and the tapered structure formed by the side wall is combined with the bottom portion, so that the reinforcing repair piece 40 can be sleeved on an anvil assembly of the tubular anastomat. The bottom 41 substantially conforms to the anvil surface of the anvil abutment and the sidewall 42 substantially conforms to the side of the abutment, forming a stable sleeved relationship. Such a connection reduces or eliminates relative movement between the stoma-strengthening repair 40 and the anvil to allow it to be stably secured to the anvil assembly.
The sidewall portion 42 of the reinforcement repair 40 has two slit cuts 44. Because the structure formed by the side wall part and the bottom part is provided with a sleeve-shaped structure with a tapered structure, the diameter of the anvil surface of the anvil assembly is larger than the opening size of the sleeve-shaped structure. The slit cuts 44 open upon installation of the stoma reinforcement prosthesis to the anvil assembly, thereby increasing the open size of the opening of the sleeve-like structure, thereby allowing the reinforcement prosthesis to be more easily assembled to the anvil assembly. When the anastomotic stoma reinforcing repair piece is assembled, the incision contracts due to the self hardness of the reinforcing repair piece, so that the reinforcing repair piece can be sleeved on the anastomotic stoma reinforcing repair assembly.
FIG. 5 is a schematic illustration of the outer contour of a reinforced prosthesis according to one embodiment of the present invention; fig. 6 is a schematic view of the outer contour of a reinforced prosthesis according to another embodiment of the present invention. Because the anvil assembly generally has a shape resembling a cone, a truncated cone, a hemisphere or a sphere or a combination thereof, the reinforcement patch is sleeved on the anvil assembly by wrapping around the structure adjacent the anvil surface. Thus, by the shaping process, the external overall profile of the reinforcement repair is given a frustoconical or bulbous shape, the top of which is open for socket engagement with the anvil assembly. The shaping treatment may be a drying treatment, for example, vacuum drying, air drying, freeze drying, or the like. The formed anastomotic stoma reinforcing repair piece has certain strength, the incision can be opened when the anastomotic stoma reinforcing repair piece is assembled on the nail anvil assembly, and the incision is restored to the original shape after the nail anvil surface enters an open space surrounded by the side wall part and the bottom surface, so that the reinforcing repair piece can be stably sheathed on the surface of the nail anvil assembly. When the anastomat is used, after the nail anvil reinforcing repair piece is assembled in the mode, the nail bin assembly anastomotic stoma reinforcing repair piece is assembled; tissue cutting is then performed. The reinforcing repair piece can be directly dried on the nail anvil assembly, and at the moment, the nail anvil assembly usually has a shape similar to a cone, a round table, a hemisphere or a sphere table or a combination of the cone and the round table, so that the side wall part of the anastomotic stoma reinforcing repair piece for the nail anvil assembly obtained after drying is inclined towards the center direction of the bottom to form a sleeve-shaped structure, and the reinforcing repair piece is directly sleeved on the nail anvil of the tubular anastomat. At this time, the side wall of the anastomotic stoma reinforcement repair piece does not need to be provided with a notch.
The foregoing description of the preferred embodiments of the present invention is not to be construed as limiting the scope of protection. The present invention is not limited to the above embodiments, and the specific structure thereof is allowed to be changed, and all changes made within the scope of the invention as independently claimed are within the scope of the invention.