Anastomotic reinforcement patch and surgical device

Abstract

The present invention provides an anastomotic reinforcement patch and a surgical device. The anastomotic reinforcement patch comprises: a biomaterial membrane, which comprises a main body and a protrusion extending outward from the main body; and a backing, the backing is detachably connected to the biomaterial membrane to form a first sleeve structure or a second sleeve structure; wherein the protrusion is configured to guide the end of the nail magazine assembly and / or the nail anvil assembly to extend into the first sleeve structure and / or the second sleeve structure when the anastomotic reinforcement patch is assembled to the nail magazine assembly and / or the nail anvil assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to Chinese Patent Application No. 202211378443.5 filed in China on November 4, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the field of medical devices, and in particular to an anastomotic reinforcement patch and a surgical device. Background Art

[0004] The application of staplers can greatly promote the development of modern surgery and minimally invasive surgery, and is of milestone significance. Staplers can staple tissues through staples while cutting, and are widely used for cutting, suturing or anastomosis of organs such as the intestine, stomach, lungs, and pancreas. However, the rigid stapling of staplers alone cannot completely avoid defects, leakage, and bleeding of anastomotic tissues, which may lead to infection, stenosis, scarring, and other problems. Once complications such as anastomotic leakage, bleeding, stenosis, infection, and adhesion occur, a second operation may be required to solve the problem, which seriously affects the patient's quality of life and even endangers his life, causing serious economic and psychological burdens on the patient.

[0005] In order to reduce the complications after anastomosis, the existing method uses a stapler with a biomaterial membrane. A layer of absorbable biomaterial membrane is installed on the stapler magazine and the staple anvil surface of the stapler. While completing the staple cutting, the biomaterial membrane is fixed on the anastomosis to protect the fragile tissue from being torn by the staples, or to close the gap between the bare staples and the tissue or blood vessels, thereby reinforcing the anastomosis and reducing the risk of complications such as anastomotic leakage and bleeding. The biomaterial membrane is a sheet structure made of degradable biomaterial, and the degradable biomaterial can be a polymer material or an animal-derived tissue material. Preferably, the degradable biomaterial can be an animal-derived tissue material that has been treated to remove immunogens, such as a submucosal material, preferably a small intestine submucosal material, a bladder submucosal material; or, for example, an organ capsule, preferably a pericardium.

[0006] However, the existing method requires that the reinforcement patch of the anastomotic stoma needs to be assembled into the stapler and anvil parts of the stapler assembly, and usually the reinforcement patch and the backing are detachably connected by wire, and then assembled into the stapler and anvil parts together. However, since the reinforcement patch is usually made of flexible material, during the assembly process of the reinforcement patch, due to the operator's operation reasons and the structural reasons between the reinforcement patch and the backing, the reinforcement patch is often not assembled to the predetermined position of the backing, or the reinforcement patch protrudes from the structural gap in the backing.

[0007] In addition, after the reinforcement patch is fixed to the tissue to be treated, the fixation between the reinforcement patch and the backing can be released by removing the wire, thereby removing the backing. However, the use of wires to fix the biomaterial layer and the backing makes the structure of the reinforcement patch complex, and special placement and fixation are required to cooperate with the stapler to ensure that the wires will not be tangled or messed up, which increases the process steps in the product manufacturing process and affects the production efficiency and product yield.

[0008] In addition, since the staples need to completely cover the contact area between the reinforcement patch and the tissue, the total length of the staples along the anastomotic reinforcement patch needs to be greater than the length of the patch. In other words, the distal length of the anastomotic line is greater than the length of the cutting line. However, the structure of the existing reinforcement patch is such that the cutting knife may not be able to cut the patch, and other cutting tools are required to complete the cutting, which increases the complexity of the operation.

[0009] Therefore, it is necessary to propose an anastomotic reinforcement patch with an improved structure so that it can more effectively cooperate with the stapler to perform the above operations to solve the above problems. Summary of the invention

[0010] The present disclosure provides a stoma reinforcement patch, which is configured to be used in conjunction with a stapler cartridge assembly and / or a stapler anvil assembly of a stapler, and the stoma reinforcement patch comprises:

[0011] A biomaterial membrane comprising a main body and a protrusion extending outward from the main body; and

[0012] A backing, the backing is detachably connected to the biomaterial membrane to form a first sleeve structure or a second sleeve structure;

[0013] Wherein, the protrusion is configured to guide the end of the nail magazine assembly and / or the nail anvil assembly to extend into the first sleeve structure and / or the second sleeve structure when the anastomotic reinforcement patch is assembled to the nail magazine assembly and / or the nail anvil assembly.

[0014] In some embodiments, the biomaterial film further comprises an extension portion extending outward from the main body portion, and a notch is provided at one end of the biomaterial film; and

[0015] A cap portion is provided at one end of the backing, and the cap portion has a receiving space for receiving the extension portion.

[0016] In some embodiments, the stapler anvil assembly is provided with a stop structure; the protrusion is configured to be able to extend into a space formed by the stop structure, the staple cartridge assembly, and the anvil assembly.

[0017] In some embodiments, the protrusion is configured to cover the nail hole in the space formed by the nail magazine assembly at the stop structure.

[0018] In some embodiments, the protrusion has an arc-shaped outer edge profile.

[0019] In some embodiments, the distal end of the protrusion extends outwardly beyond the suturing end point of the wire in the length direction of the main body.

[0020] In some embodiments, the main body has a length direction and a width direction, and the width of the protrusion along the width direction is smaller than the width of the main body.

[0021] In some embodiments, when the anastomotic reinforcement patch is used in conjunction with the stapler stapler assembly, the protrusion guides the first end of the stapler stapler assembly to extend into the first sleeve structure, and the protrusion covers the surface of the stapler assembly within the space formed at the stop structure.

[0022] In some embodiments, when the anastomotic reinforcement patch is used in conjunction with the anvil assembly of the stapler, the protrusion guides the first end of the anvil assembly of the stapler to extend into the second sleeve structure, and the protrusion covers the surface of the anvil assembly in the space formed at the stop structure.

[0023] In some embodiments, the anastomotic reinforcement patch further includes a guide port, and the guide port is disposed on at least a portion of the main body and the protruding portion.

[0024] The present disclosure also provides a surgical device, the surgical device comprising:

[0025] A stapler comprising a staple cartridge assembly and a staple anvil assembly; and

[0026] The anastomotic reinforcement patch as described in any one of the above items is used in conjunction with the stapler.

[0027] The present disclosure also provides a stoma reinforcement patch, which is configured to be used in conjunction with a stapler cartridge assembly and / or a stapler anvil assembly of a stapler, and the stoma reinforcement patch comprises:

[0028] A biomaterial membrane, comprising a main body and an extension extending outward from the main body, wherein a notch is provided at one end of the biomaterial membrane; and

[0029] A backing is detachably connected to the biomaterial membrane, and a cap is provided at one end of the backing, wherein the cap has a receiving space for receiving the extension.

[0030] In some embodiments, when the anastomotic reinforcement patch is used in conjunction with the stapler magazine assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured with wire to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler magazine assembly to form the anastomotic reinforcement patch in a first usage state.

[0031] In some embodiments, further comprising:

[0032] When the anastomotic stoma reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured with wire to form a second sleeve structure, and the second sleeve structure is sleeved on the anvil assembly of the stapler to form the anastomotic stoma reinforcement patch in a second usage state.

[0033] In some embodiments, the depth of the receiving space of the cap portion is less than or equal to the length of the extension portion in the length direction of the biomaterial membrane.

[0034] In some embodiments, the extension portion is formed by extending outward from a portion of the first end of the main body portion.

[0035] In some embodiments, the cutout is disposed in the extension portion and is partially disposed in the main body portion;

[0036] The incision is used to cooperate with the cutting assembly of the stapler so that the position reached by the front end of the cutting assembly coincides with the preset cutting position.

[0037] In some embodiments, the main body is provided with a guide opening at a second end opposite to the first end.

[0038] In some embodiments, a center line of the guide port in the length direction of the biomaterial film sheet coincides with a center line of the cutout in the length direction of the biomaterial film sheet.

[0039] In some embodiments, the biomaterial membrane further includes a protrusion extending outward from the main body; and

[0040] The backing is detachably connected to the biomaterial membrane to form a first sleeve structure or a second sleeve structure;

[0041] The protrusion is configured to guide the end of the nail magazine assembly and / or the nail anvil assembly to extend into the first sleeve structure and / or the second sleeve structure when the anastomotic reinforcement patch is assembled to the nail magazine assembly and / or the nail anvil assembly.

[0042] The present disclosure also provides a surgical device, the surgical device comprising:

[0043] A stapler comprising a staple cartridge assembly and a staple anvil assembly; and

[0044] The anastomotic reinforcement patch as described in any one of the above items is used in conjunction with the stapler.

[0045] In some embodiments, it also includes:

[0046] When the anastomotic reinforcement patch is used in conjunction with the stapler assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured by wire to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler assembly of the stapler to form the anastomotic reinforcement patch in a first use state; and / or

[0047] When the anastomotic stoma reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured with wire to form a second sleeve structure, and the second sleeve structure is sleeved on the anvil assembly of the stapler to form the anastomotic stoma reinforcement patch in a second usage state.

[0048] Compared with the related art, the present disclosure has at least the following technical effects:

[0049] Compared with the prior art, the anastomotic reinforcement patch of the present invention, by providing an extension portion on the biomaterial membrane and providing a receiving space for receiving the extension portion on the backing, utilizes at least a portion of the extension portion of the biomaterial membrane to be plugged in and out of the cap portion of the backing to form a sleeve structure, which can effectively avoid the problem of erroneous operation or assembly misalignment such as the biomaterial membrane not being assembled to the predetermined position of the backing, or the biomaterial membrane extending from the structural gap in the backing, and can also directly perform reinforcement repair and anastomosis of the anastomosis after cutting; by providing an incision on the biomaterial membrane, the cutting position of the cutting assembly of the stapler during cutting of the tissue to be treated is limited by the incision, so that the position reached by the first end of the cutting assembly (i.e., the front end that first contacts the tissue to be treated when used) coincides with the preset cutting position, which can ensure that the cutting assembly completely cuts off the reinforcement patch, and at the same time ensures that the anastomosis is completely anastomosed, without the need to use additional cutting tools, thereby improving the convenience of operation.

[0050] In addition, by providing a guide port in the reinforcement patch, the shear force of the cutting assembly when cutting the patch can be reduced, thereby avoiding the risk of curling of the patch and causing adverse cutting. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0052] Figure 1 A schematic diagram of the three-dimensional structure of an example of an anastomotic reinforcement patch provided by the present invention;

[0053] Figure 2 for Figure 1 An exploded view of the three-dimensional structure of an example of an anastomotic reinforcement patch;

[0054] Figure 3 for Figure 1 A three-dimensional structural exploded diagram of an application example of an anastomotic reinforcement patch;

[0055] Figure 4 for Figure 1 A schematic diagram of another example of anastomotic reinforcement patch;

[0056] Figure 5 A three-dimensional structural solid diagram of another example of anastomotic reinforcement patch provided by the present invention;

[0057] Figure 6 for Figure 5 The three-dimensional structure explosion diagram of the anastomotic reinforcement patch;

[0058] Figure 7 for Figure 5 A schematic diagram of a three-dimensional structure of another application example of the anastomotic reinforcement patch;

[0059] Figure 8 for Figure 5 A schematic diagram of another example of anastomotic reinforcement patch;

[0060] Fig. 9 A schematic three-dimensional structural diagram of another application example of the anastomotic reinforcement patch provided by the present invention. DETAILED DESCRIPTION

[0061] In order to make the purpose, technical solutions and advantages of the present disclosure clearer, the present disclosure will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0062] The terms used in the embodiments of the present disclosure are only for the purpose of describing specific embodiments, and are not intended to limit the present disclosure. The singular forms "a", "said" and "the" used in the embodiments of the present disclosure and the appended claims are also intended to include plural forms, unless the context clearly indicates other meanings, and "multiple" generally includes at least two.

[0063] It should be understood that the term "and / or" used in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0064] It should also be noted that the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a product or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such product or device. In the absence of more restrictions, the elements defined by the sentence "comprises a" do not exclude the presence of other identical elements in the product or device including the elements.

[0065] The present disclosure provides an anastomotic reinforcement patch, which is configured to be used in conjunction with a stapler magazine assembly and / or a stapler anvil assembly, the anastomotic reinforcement patch comprising: a biomaterial membrane, which comprises a main body and an extension portion extending outward from the main body, one end of the biomaterial membrane being provided with a cutout; and a backing detachably connected to the biomaterial membrane, one end of the backing being provided with a cap portion, the cap portion having a receiving space for receiving the extension portion.

[0066] By adopting the anastomotic reinforcement patch provided by the present invention, an extension portion is provided on the biomaterial membrane, and a receiving space with a receiving extension portion is provided on the backing, and at least a part of the extension portion of the biomaterial membrane can be plugged and pulled out of the cap portion of the backing to form a sleeve structure, it can effectively avoid the problem of erroneous operation or assembly misalignment such as the biomaterial membrane not being assembled to the predetermined position of the backing, or the biomaterial membrane extending from the structural gap in the backing, and the anastomotic reinforcement repair and anastomosis can be directly performed after cutting; by providing an incision on the biomaterial membrane, the cutting position of the cutting component of the stapler when cutting the tissue to be treated is limited by the incision, so that the position reached by the first end of the cutting component (that is, the front end that first contacts the tissue to be treated when used) coincides with the preset cutting position, which can ensure that the cutting component completely cuts off the reinforcement patch, and at the same time ensures that the anastomosis is completely anastomosed, without the need to use additional cutting tools, thereby improving the convenience of operation.

[0067] In addition, by providing a guide port in the reinforced patch, the shear force of the cutting assembly when cutting the patch can be reduced, thereby avoiding the risk of curling of the patch and causing adverse cutting.

[0068] It should be noted that the anastomotic reinforcement patch of the present invention is widely used, and is particularly suitable for application scenarios of a stapler that places a reinforcement patch at a designated position and fixes the reinforcement patch, such as cutting, suturing or anastomosis of organ tissues such as intestines, stomach, lungs, and pancreas. The optional embodiments of the present disclosure are described in detail below in conjunction with the accompanying drawings.

[0069] In order to further optimize the structure of the anastomotic reinforcement patch and accurately assist the stapler in cutting the tissue to be processed and anastomosing the anastomotic stoma, the structures of the components in the anastomotic reinforcement patch are improved, so that the anastomotic stoma can be accurately positioned and cut during the cutting and anastomosis operations of the stapler, effectively avoiding the problems such as the anastomotic stoma not being closed or torn after the anastomosis, the reinforcement patch not being assembled to the predetermined position of the backing, or the reinforcement patch extending from the structural gap in the backing, and the patch being unable to be cut off during cutting, thereby achieving more effective anastomosis. The improved structure of the present invention will be described in detail below.

[0070] Figure 1 A schematic three-dimensional structure diagram of an example of an anastomotic reinforcement patch provided by the present invention.

[0071] like Figure 1 As shown, the present disclosure provides an anastomotic reinforcement patch 10 , wherein the anastomotic reinforcement patch 10 (also referred to as a first anastomotic reinforcement patch 10 in this embodiment) comprises a first biomaterial membrane 11 and a first backing 13 detachably connected to the first biomaterial membrane 11 .

[0072] Specifically, the first biomaterial film 11 and the first backing 13 are preferably detachably connected by a wire 60, and specifically, the two sides of the first biomaterial film 11 in the width direction and the two sides of the first backing 13 in the width direction are detachably connected by the wire 60 along the length direction of the first biomaterial film 11, as can be seen in Figure 1 .

[0073] Optionally, the first biomaterial film 11 is used in a variety of soft tissue repair clinical surgeries, etc. For example, when a stapler is used to treat the tissue to be treated, and when staples are used to suture, for example, the first biomaterial film 11 is detached from the first backing 11 and the second backing 21 to fix and repair the anastomosis of the tissue to be treated. The first biomaterial film 11 can achieve in vivo degradation and tissue regeneration, can effectively reinforce and repair the anastomosis, and protect the tissue from being torn by the staples.

[0074] It should be noted that in the present invention, the first biomaterial film is, for example, an in vivo degradable polymer material or an in vivo degradable biomaterial, wherein the polymer material includes, for example, polypropylene, polylactic acid (PLA), polyglycolic acid (PGA) or polylactic acid glycolic acid (PLGA).

[0075] Figure 2 for Figure 1 An exploded view of the three-dimensional structure of an example of an anastomotic reinforcement patch.

[0076] like Figure 2 As shown, the first biomaterial film 11 includes a first main body 111, a first extension 113 extending outward from the main body 111, and a first cutout 115 is provided at one end of the first biomaterial film 11, wherein the first main body 111 is generally strip-shaped, and the orthographic projection on a plane parallel to the horizontal plane is generally rectangular, but not limited thereto, in other examples, the orthographic projection may also be a chamfered rectangle or other polygonal shape. The above is only described as an optional example and cannot be understood as a limitation of the present invention.

[0077] It should be noted that in the present invention, the end of the component or part on the left side of the drawing paper is called the first end, the end of the component or part on the right side of the drawing paper (i.e., the end opposite to the first end) is called the second end, the upper side of the drawing paper is called the upper side, and the lower side of the drawing paper is called the lower side.

[0078] Specifically, a first extension portion 113 is provided at the first end of the first main body portion 111, that is, the first extension portion 113 is formed by extending outward from a portion (in this example, the central portion) of the first end of the first main body portion 111. More specifically, the first extension portion 113 is inclined outward from the first main body portion 111, for example, Figure 2 Tilts downward and left as shown.

[0079] It should be noted that, in other examples, the first inclined portion 111 may also be located on the same horizontal plane as the first main body portion 111. In addition, there is no particular restriction on the shape of the first extension portion, as long as the shape is easy to plug in and out. The above is only described as an optional example and cannot be understood as a limitation of the present invention.

[0080] exist Figure 2 In the example shown, the first cutout 115 is disposed in the first extension portion 113 and partially disposed in the first main body portion 111, and the first cutout 115 is disposed along the length direction of the first main body portion 111. Figure 2 It can be seen that the first extension portion 113 is divided into two parts by the first cutout 115 .

[0081] Furthermore, a first cap portion 130 is disposed at one end of the first backing 13 , and the first cap portion 130 has a receiving space S1 for receiving the first extension portion 113 .

[0082] Optionally, the depth d1 of the receiving space S1 of the first cap portion 130 is less than or equal to the length c of the first extension portion 113 in the length direction of the first biomaterial membrane 11, as shown in FIG. Figure 2 .

[0083] Preferably, a depth d1 of the receiving space S1 of the first cap portion 130 is less than or equal to 1 / 2 of a length c of the first extending portion 113 in the length direction of the first biomaterial membrane 11 .

[0084] It should be noted that the above is only described as an optional example and should not be understood as a limitation to the present invention.

[0085] Figure 3 for Figure 1 A three-dimensional structural exploded diagram of an application example of an anastomotic reinforcement patch. Figure 3 The following figure shows the use of the anastomotic reinforcement patch of the present invention in conjunction with the stapler assembly of the stapler. Figure 3 The application example further illustrates the improved structure of the anastomotic reinforcement patch of the present invention.

[0086] See also Figure 1 and Figure 3 When the first anastomotic stoma reinforcement patch 10 is used in conjunction with the stapler magazine assembly 30 of the stapler 200, at least a portion of the first extension portion 113 is inserted into the first cap portion 130, and the first biomaterial membrane 11 and the first backing 13 are detachably sutured by wire 60 to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler magazine assembly 30 of the stapler 200 to form the first anastomotic stoma reinforcement patch in the first usage state.

[0087] Specifically, by providing the first cap portion 130 on the first backing 13 and setting the depth of the receiving space S1 of the first cap portion 130, at least a portion of the first extension portion 113 is inserted into the first cap portion 130, that is, the structure of accommodating the first extension portion 113 by the first cap portion 130 can effectively ensure that the first biomaterial membrane is inserted into the first cap portion.

[0088] Furthermore, by inserting a portion of the first extension portion 113 into the first cap portion 130 and detachably sewing the first biomaterial membrane 11 and the first backing 13 through the wire 60 to form a first sleeve structure, it is possible to more effectively ensure that the first biomaterial membrane is inserted into the first cap portion, thereby more effectively avoiding operational errors or assembly misalignment problems such as the biomaterial membrane not being assembled to the predetermined position of the backing, or the biomaterial membrane extending from the structural gap in the backing, and the anastomosis can be directly reinforced, repaired, and anastomosed after cutting.

[0089] In addition, a first incision 115 is also provided on the first main body 111. The first incision 115 is used in conjunction with the cutting assembly of the stapler 200. The first incision 115 limits the cutting position of the cutting assembly when cutting the tissue to be treated, so that the position reached by the first end of the cutting assembly (i.e., the front end that first contacts the tissue to be treated when in use) coincides with the preset cutting position, which can ensure that the cutting assembly completely cuts off the reinforcement patch and at the same time ensures that the anastomosis is completely anastomosed without the use of additional cutting tools, thereby improving the convenience of operation.

[0090] Figure 4 for Figure 1 Schematic diagram of another example of anastomotic reinforcement patch.

[0091] Figure 4 Examples with Figure 3 The difference from the example is that a first guide port 117 is provided at a second end of the first main body portion 111 of the first biomaterial membrane 11 opposite to the first end.

[0092] Specifically, the first guide opening 117 is a through hole penetrating the first main body 111, and the center line of the first guide opening 117 along the length direction of the first main body 111 coincides with the center line of the first incision 115 along the length direction of the first main body 111. The first guide opening 117 is used to guide the cutting assembly of the stapler to perform a cutting operation, which can reduce the shear force of the cutting assembly when cutting the patch, and avoid the risk of the patch curling and causing adverse cutting.

[0093] It should be noted that due to Figure 4 In the example of the first backing with Figure 1 The structure of the first backing is roughly the same, so the description of the same parts is omitted.

[0094] Reference Figures 5 to 9 Another example of an anastomotic reinforcing patch according to the present invention will be described.

[0095] It should be noted that, in the present embodiment, the anastomotic reinforcement patch (in the present embodiment, also referred to as the second anastomotic reinforcement patch 20 ) is used in conjunction with the anvil assembly of the stapler.

[0096] Figure 5 A three-dimensional structural solid diagram of another example of the anastomotic reinforcement patch provided by the present invention. Figure 6 for Figure 5 Exploded view of the three-dimensional structure of the anastomotic reinforcement patch.

[0097] like Figure 5 and Figure 6 As shown, the second anastomotic reinforcement patch 20 includes a second biomaterial film 21 and a second backing 23 , and the second backing 23 is detachably connected to the second biomaterial film 21 .

[0098] Optionally, the second biomaterial film 21 and the second backing 23 are detachably connected by a wire 61, specifically, the two side edges in the width direction of the second biomaterial film 21 and the two side edges in the width direction of the second backing 23 are detachably connected by the wire 61 along the length direction of the second biomaterial film 21.

[0099] Specifically, the second biomaterial membrane 21 includes a second main body portion 211 and a second extension portion 213 extending outward from the second main body portion 211 , and the second extension portion 213 is divided into two parts by the second incision 215 , that is, the second extension portion 213 is two protrusions protruding outward from the second main body portion 213 .

[0100] Furthermore, a second cap portion 230 is disposed at one end (ie, the first end) of the second backing 23 , and the second cap portion 230 has a receiving space S2 for receiving the second extension portion 213 .

[0101] Optionally, the depth d2 of the receiving space S1 of the second cap portion 230 is less than or equal to the length c2 of the second extension portion 213 in the length direction of the second biomaterial membrane 11, as shown in FIG. Figure 6 .

[0102] Preferably, a depth d2 of the receiving space S1 of the second cap portion 230 is less than or equal to 1 / 2 of a length c2 of the second extending portion 213 in the length direction of the second biomaterial membrane 11 .

[0103] During assembly and use, at least a portion of the second extension portion 213 is inserted into the second cap portion 230, and the second biomaterial membrane 21 and the second backing 23 are detachably sewn together by wire 61 to form a second sleeve structure (see 7).

[0104] It should be noted that Figure 5 In the example shown, the second biomaterial film 21, the second backing 23 and Figure 1 The structures of the first biomaterial film 11 and the first backing 13 in the example shown are substantially the same, and the function and preparation materials of the second biomaterial film 21 in Example 2 are substantially the same as those of the first biomaterial film 11 in Example 1, so the description of the same parts is omitted.

[0105] Figure 7 for Figure 5 A schematic three-dimensional structural diagram of another application example of the anastomotic reinforcement patch.

[0106] Figure 7 The figure shows the use of the anastomotic reinforcement patch (i.e., the second anastomotic reinforcement patch) of the present invention in combination with the anvil assembly of the stapler.

[0107] like Figure 7 As shown, when the second anastomotic stoma reinforcement patch 20 is used in conjunction with the anvil assembly 40 of the stapler 200, at least a portion of the second extension portion 213 is inserted into the second cap portion 230, and the second biomaterial membrane 21 and the second backing 23 are detachably sutured by wire 61 to form a second sleeve structure, and the second sleeve structure is sleeved on the anvil assembly 40 of the stapler 200 to form the anastomotic stoma reinforcement patch in the second usage state.

[0108] Through the above-mentioned second sleeve structure, it is possible to more effectively ensure that the second biomaterial membrane is inserted into the second cap portion, thereby more effectively avoiding operational errors or assembly misalignment problems such as the biomaterial membrane not being assembled to the predetermined position of the backing, or the biomaterial membrane extending from the structural gap in the backing, and the anastomosis can be directly reinforced, repaired and anastomosed after cutting.

[0109] Optionally, the length a of the second cutout 215 in the length direction of the second main body 211 is less than 1 / 2 of the length b of the second main body 211 in the length direction thereof. Figure 8 .

[0110] Preferably, a length a of the second cutout 115 in the length direction of the second body portion 211 is smaller than 1 / 2 of a length b of the second body portion 211 in the length direction thereof.

[0111] By setting the second incision and its length, it can be further ensured that the cutting assembly completely cuts off the reinforcement patch, while ensuring complete anastomosis of the anastomosis without the need for additional cutting tools, thereby improving operational convenience.

[0112] Figure 8 for Figure 5Schematic diagram of another example of anastomotic reinforcement patch.

[0113] Figure 8 Examples with Figure 5 The difference from the example is that a second guide port 217 is provided at a second end of the second main body portion 211 of the second biomaterial membrane 21 opposite to the first end.

[0114] Specifically, the second guide opening 217 is a through hole penetrating the first main body 211 , and the position of the second guide opening 217 corresponds to the position of the first guide opening 117 .

[0115] Furthermore, the center line of the second guide opening 217 along the length direction of the second main body 211 coincides with the center line of the second incision 215 along the length direction of the second main body 211. The second guide opening 217 is used to guide the cutting assembly of the stapler to perform the cutting operation, which can further reduce the shear force of the cutting assembly when cutting the patch, and avoid the risk of the patch curling and causing adverse cutting.

[0116] Another embodiment of the present disclosure further provides a stoma reinforcement patch 10, such as Figure 1-4 and Fig. 9 As shown, it is configured to be used in conjunction with the stapler assembly 30 of the stapler. The anastomotic reinforcement patch 10 comprises: a biomaterial membrane 11, which comprises a first main body 111 and a first protrusion 112 extending outward from the first main body 111; and a backing 13, the backing 13 is detachably connected to the biomaterial membrane 11 to form a first sleeve structure.

[0117] In some embodiments, Figure 1-3 As shown, the stapler anvil assembly 40 is provided with a stop structure 41. The first protrusion 112 extending outward from the first main body 111 of the biomaterial membrane 11 of the present disclosure can extend into the space formed by the stop structure 41, the staple cartridge assembly 30 and the staple anvil assembly 40. The first protrusion 112 can cover the surface of the staple cartridge assembly 30 in the space.

[0118] In some embodiments, Figure 1-2 As shown, the farthest end of the first protrusion 112 extending outward from the first main body 111 of the biomaterial membrane 11 of the present disclosure exceeds the suture end point of the wire 60 in the length direction.

[0119] In some embodiments, the first main body portion 111 has a length direction and a width direction, and the maximum width of the first protrusion 112 along the width direction is smaller than the maximum width of the main body portion 111 .

[0120] In some embodiments, the first protrusion 112 is configured to guide the end of the staple cartridge assembly 30 to extend into the first sleeve structure when the anastomotic reinforcement patch 10 is assembled to the staple cartridge assembly 30 .

[0121] In some embodiments, Figure 3 As shown, the first protrusion 112 enters the space formed by the stop structure 41, and can cover the surface of the stapler assembly and / or the anvil assembly in the space, thereby preventing the formation of exposed titanium staples after the stapler is fired. In other words, if there is no coverage by the first protrusion 112, there is a risk that some of the titanium staple holes will not be covered by the biological patch.

[0122] In some embodiments, Figure 1-2 As shown, the first protrusion 112 may have an arc-shaped outer edge profile.

[0123] In some embodiments, when the anastomotic reinforcement patch 10 is used in conjunction with the stapler stapler assembly 30, the first protrusion 112 guides the first end of the stapler stapler assembly 30 to extend into the first sleeve structure, and the first protrusion 112 covers the surface of the stapler stapler assembly 30 in the space formed at the stop structure 41.

[0124] In some embodiments, Figure 4 As shown, the anastomotic reinforcement patch 10 further includes a first guide opening 117 , a portion of the first guide opening 117 is disposed on the first protruding portion 112 , and another portion of the first guide opening 117 is disposed on the main body 111 .

[0125] Another embodiment of the present disclosure further provides a stoma reinforcement patch 20, such as Figure 5-9 As shown, it is configured to be used in conjunction with the stapler anvil assembly 40. The anastomotic stoma reinforcement patch 20 comprises: a biomaterial membrane 21, which comprises a second main body 211 and a second protrusion 212 extending outward from the second main body 211; and a backing 23, the backing 23 is detachably connected to the biomaterial membrane 21 to form a second sleeve structure.

[0126] In some embodiments, Figure 5-7 As shown, the anvil assembly 40 is provided with a stop structure 41. The second protrusion 212 extending outward from the second main body 211 of the biomaterial membrane 21 of the present disclosure can extend into the space formed by the stop structure 41, the nail cartridge assembly 30 and the anvil assembly 40. The second protrusion 212 can cover the surface of the anvil assembly 40 in the space.

[0127] In some embodiments, Figure 5-6As shown, the farthest end of the second protrusion 212 extending outward from the second main body 211 of the biomaterial membrane 21 of the present disclosure exceeds the suture end point of the wire 61 in the length direction.

[0128] In some embodiments, the second main body portion 211 has a length direction and a width direction, and the maximum width of the second protrusion 212 along the width direction is smaller than the maximum width of the main body portion 211 .

[0129] In some embodiments, the second protrusion 212 is configured to guide the end of the anvil assembly 40 to extend into the second sleeve structure when the anastomotic reinforcement patch 20 is assembled to the anvil assembly 40 .

[0130] In some embodiments, Figure 5 and Figure 7 As shown, the second protrusion 212 enters the space formed by the stop structure 41, and can cover the surface of the stapler assembly and / or the anvil assembly in the space, thereby preventing the formation of exposed titanium staples after the stapler is fired. In other words, if the second protrusion 212 is not covered, there is a risk that some of the titanium staple holes will not be covered by the biological patch.

[0131] In some embodiments, Figure 5-6 As shown, the second protrusion 212 may have an arc-shaped outer edge profile.

[0132] In some embodiments, when the anastomotic reinforcement patch 20 is used in conjunction with the anvil assembly 40 of the stapler, the second protrusion 212 guides the end of the anvil assembly 40 of the stapler so that it extends into the second socket structure, and the second protrusion 212 covers the surface of the anvil assembly 40 in the space formed at the stop structure 41.

[0133] In some embodiments, Figure 8 As shown, the anastomotic reinforcement patch 20 further includes a second guide opening 217 , a portion of the second guide opening 217 is disposed on the second protruding portion 212 , and another portion of the second guide opening 217 is disposed on the main body 211 .

[0134] The present invention also provides a surgical device, which is used to perform cutting, anastomosis and other treatments on the tissue to be treated. Figure 1 , Figure 3 , Figure 5 , Figure 7 and Fig. 9 , describing the surgical device of the present invention.

[0135] Specifically, the surgical device includes a stapler 200 and a stoma reinforcement patch used in conjunction with the stapler 200 , wherein the stapler 200 includes a staple cartridge assembly 30 and a staple anvil assembly 40 .

[0136] In the first embodiment, the anastomotic reinforcement patch is the first anastomotic reinforcement patch 11 in Example 1. That is, the anastomotic reinforcement patch is only used for sleeve connection of the staple cartridge assembly 30. For details, see Figure 3 .

[0137] like Figure 3 As shown, when the first anastomotic stoma reinforcement patch 11 is used in conjunction with the stapler magazine assembly 30 of the stapler 200, at least a portion of the first extension portion 113 is inserted into the first cap portion 130, and the first biomaterial membrane 11 and the first backing 13 are detachably sutured by wire 60 to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler magazine assembly 30 of the stapler 200 to form the anastomotic stoma reinforcement patch in the first usage state.

[0138] Optionally, the depth d1 of the receiving space S1 of the first cap portion 130 is less than or equal to the length c of the first extension portion 113 in the length direction of the first biomaterial membrane 11, as shown in FIG. Figure 2 .

[0139] Preferably, a depth d1 of the receiving space S1 of the first cap portion 130 is less than or equal to 1 / 2 of a length c of the first extending portion 113 in the length direction of the first biomaterial membrane 11 .

[0140] In addition, a first incision 115 is provided on the first main body portion 111 , and the first incision 115 is used in cooperation with the cutting assembly 50 of the stapler 200 .

[0141] Specifically, the length of the first cutout 115 in the length direction of the first body portion 111 is less than 1 / 2 of the length of the first body portion 111 in the length direction thereof.

[0142] Preferably, the length of the first cutout 115 in the length direction of the first body portion 111 is less than 1 / 3 of the length of the first body portion 111 in the length direction thereof.

[0143] The first incision 115 limits the cutting position of the cutting assembly when cutting the tissue to be treated, so that the position reached by the first end of the cutting assembly (i.e., the front end that first contacts the tissue to be treated when in use) coincides with the preset cutting position, thereby ensuring that the cutting assembly completely cuts off the reinforcement patch and that the anastomosis is completely anastomosed without the need for additional cutting tools, thereby improving operational convenience.

[0144] It should be noted that, since the structure of the first anastomosis reinforcement patch 11 in the first embodiment is substantially the same as the structure of the first anastomosis reinforcement patch 11 in Example 1, the description of the same parts is omitted.

[0145] In the second embodiment, the anastomotic reinforcement patch is the second anastomotic reinforcement patch 21 in Example 2. That is, the anastomotic reinforcement patch is only used for sleeve connection of the nail anvil assembly 40. For details, see Figure 7 .

[0146] like Figure 7 As shown, when the second anastomotic stoma reinforcement patch 20 is used in conjunction with the anvil assembly 40 of the stapler 200, at least a portion of the second extension portion 213 is inserted into the second cap portion 230, and the second biomaterial membrane 21 and the second backing 23 are detachably sutured by wire 61 to form a second sleeve structure, and the second sleeve structure is sleeved on the anvil assembly 40 of the stapler 200 to form the anastomotic stoma reinforcement patch in the second usage state.

[0147] It should be noted that, since the structure of the second anastomotic reinforcement patch 20 in the second embodiment is substantially the same as the structure of the second anastomotic reinforcement patch 21 in Example 2, the description of the same parts is omitted.

[0148] In the third embodiment, the anastomotic reinforcement patch includes the first anastomotic reinforcement patch 11 in Example 1 and the second anastomotic reinforcement patch 21 in Example 2, that is, the anastomotic reinforcement patch is used to sleeve the nail magazine assembly 30 and the nail anvil assembly 40. For details, see Fig. 9 .

[0149] like Fig. 9 As shown, when the first anastomotic reinforcement patch 11 is used in conjunction with the stapler magazine assembly 30 of the stapler 200, and the second anastomotic reinforcement patch 20 is used in conjunction with the stapler anvil assembly 40 of the stapler 200, the first biomaterial membrane 11 and the first backing 13 are detachably sewn by wire 60 to form a first sleeve structure, and the second biomaterial membrane 21 and the second backing 23 are detachably sewn by wire 61 to form a second sleeve structure.

[0150] Specifically, at least a portion of the first extension portion 113 is inserted into the first cap portion 130, and the first biomaterial membrane 11 and the first backing 13 are detachably sewn together by the wire 60 to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler assembly 30 of the stapler 200 to form an anastomotic reinforcement patch in the first use state. In addition, at least a portion of the second extension portion 213 is inserted into the second cap portion 230, and the second biomaterial membrane 21 and the second backing 23 are detachably sewn together by the wire 61 to form a second sleeve structure, and the second sleeve structure is sleeved on the stapler anvil assembly 40 of the stapler 200 to form an anastomotic reinforcement patch in the second use state.

[0151] In the third embodiment, the second biomaterial membrane 21 is provided with a second incision 215 corresponding to the position of the first incision 115. The first incision and the second incision with corresponding positions cooperate with the cutting assembly of the stapler to perform related operations, thereby further ensuring that the cutting assembly completely cuts off the reinforcement patch and at the same time ensuring that the anastomosis is completely anastomosed without the use of additional cutting tools, thereby improving the convenience of operation.

[0152] Regarding the lengths of the first cutout 115 and the second cutout 215 , the length of the first cutout 115 in the longitudinal direction of the first body portion 111 is equal to the length of the second cutout 215 in the longitudinal direction of the second body portion 211 .

[0153] Specifically, the length of the first cutout 115 in the length direction of the first body portion 111 is less than 1 / 2 of the length of the first body portion 111 in the length direction thereof.

[0154] Preferably, the length of the first cutout 115 in the length direction of the first body portion 111 is less than 1 / 3 of the length of the first body portion 111 in the length direction thereof.

[0155] In another embodiment, a first guide opening 117 is provided at a second end of the first body portion 111 opposite to the first end, and a second guide opening 217 corresponding to the position of the first guide opening 117 is provided at the second body portion 211 .

[0156] In this embodiment, the center line of the first guide opening 117 in the length direction of the first biomaterial film 11 (i.e., the first main body 111) coincides with the center line of the first cutout 115 in the length direction of the first biomaterial film 11 (i.e., the first main body 111). Correspondingly, the center line of the second guide opening 217 in the length direction of the second biomaterial film 21 (i.e., the second main body 211) coincides with the center line of the second cutout 215 in the length direction of the second biomaterial film 21 (i.e., the second main body 211).

[0157] It should be noted that the above is only described as an optional example and should not be understood as a limitation to the present invention.

[0158] Compared with the prior art, the surgical device of the present invention can effectively avoid erroneous operation or assembly misalignment problems such as the biomaterial membrane not being assembled to the predetermined position of the backing or the biomaterial membrane extending from the structural gap in the backing by improving the structure of the anastomotic reinforcement modification sheet, and can also directly perform reinforcement repair and anastomosis of the anastomosis after cutting; the cutting position of the cutting component of the stapler during cutting of the tissue to be treated is limited by the incision, so that the position reached by the first end of the cutting component (that is, the front end that first contacts the tissue to be treated when used) coincides with the preset cutting position, which can ensure that the cutting component completely cuts off the reinforcement patch and ensures complete anastomosis of the anastomosis without the use of additional cutting tools, thereby improving the convenience of operation; by setting a guide port on the reinforcement patch, the shear force of the cutting component when cutting the patch can be reduced, avoiding the risk of curling of the patch and causing adverse cutting.

[0159] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other. For the system or device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part description.

[0160] The above embodiments are only used to illustrate the technical solutions of the present disclosure, rather than to limit them. Although the present disclosure has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present disclosure.

Claims

1. An anastomotic reinforcement patch, which is configured to be used in conjunction with a stapler cartridge assembly and / or anvil assembly of a stapler, characterized in that: The anastomotic reinforcement patch comprises: A biomaterial membrane comprising a main body and a protrusion extending outward from the main body; and A backing, wherein the backing is detachably connected to the biomaterial membrane through a wire to form a first sleeve structure and / or a second sleeve structure; The main body has a length direction and a width direction, and the width of the protrusion along the width direction is smaller than the width of the main body; the farthest end of the protrusion extending outward in the length direction of the main body exceeds the suture end point of the wire, and the farthest end of the backing in the length direction of the main body exceeds the farthest end of the protrusion; The protrusion is configured to guide the end of the staple cartridge assembly and / or the anvil assembly to extend into the first sleeve structure and / or the second sleeve structure when the anastomotic reinforcement patch is assembled to the staple cartridge assembly and / or the anvil assembly; the staple cartridge assembly or the anvil assembly of the stapler is provided with a stop structure; the protrusion is configured to be able to extend into a space formed by the stop structure and the staple cartridge assembly or the anvil assembly, and the protrusion is configured to cover the surface of the staple cartridge assembly and / or the anvil assembly in the space formed at the stop structure; The biomaterial membrane also includes an extension portion extending outward from the main body, one end of the biomaterial membrane is provided with a cutout; and one end of the backing is provided with a cap portion, the cap portion has a receiving space for receiving the extension portion.

2. The anastomotic reinforcement patch according to claim 1, wherein: The protrusion has an arc-shaped outer edge contour.

3. The anastomotic reinforcement patch according to claim 1, wherein: The anastomotic reinforcement patch further includes a guide port, which is disposed on the main body and at least a portion of the protruding portion.

4. A surgical device, characterized in that: The surgical device comprises: A stapler comprising a staple cartridge assembly and a staple anvil assembly; and The anastomotic reinforcement patch according to any one of claims 1 to 3 is used in conjunction with the anastomotic device.

5. The surgical device according to claim 4, wherein: Also includes: When the anastomotic reinforcement patch is used in conjunction with the stapler assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured by wire to form a first sleeve structure, and the first sleeve structure is sleeved on the stapler assembly of the stapler to form the anastomotic reinforcement patch in a first use state; and / or When the anastomotic stoma reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension portion is inserted into the cap portion, and the biomaterial membrane and the backing are detachably sutured with wire to form a second sleeve structure, and the second sleeve structure is sleeved on the anvil assembly of the stapler to form the anastomotic stoma reinforcement patch in a second usage state.

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