WO2024051861A1

WO2024051861A1 - Anastomosis reinforcement patch and surgical apparatus

Info

Publication number: WO2024051861A1
Application number: PCT/CN2023/124466
Authority: WO
Inventors: 陈慧军; 费福垒; 王华生; 赵博; 李学军
Original assignee: 北京博辉瑞进生物科技有限公司
Priority date: 2022-11-04
Filing date: 2023-10-13
Publication date: 2024-03-14
Also published as: CN115998352A

Abstract

An anastomosis reinforcement patch (10) and a surgical apparatus. The anastomosis reinforcement patch (10) comprises: a biomaterial membrane piece (11), which comprises a main body part (111) and a protruding part (112) extending outwards from the main body part (111); and a backing (113), the backing (113) being detachably connected to the biomaterial membrane piece (11) to form a first sleeving structure or a second sleeving structure; wherein the protruding part (112) is configured so that when the anastomosis reinforcement patch (10) is assembled to a staple cartridge assembly (30) and/or an anvil assembly (40), same guides an end part of the anvil assembly (40) and/or the staple cartridge assembly (30) and causes same to extend into the first sleeving structure and/or the second sleeving structure.

Description

Anastomotic reinforcement patches and surgical devices

Cross-references to related applications

This disclosure claims priority to Chinese Patent Application No. 202211378443.5 filed in China on November 4, 2022, the entire content of which is incorporated herein by reference.

Technical field

The present disclosure relates to the field of medical devices, and in particular, to an anastomotic reinforcing patch and a surgical device.

Background technique

The application of staplers can greatly promote the development of modern surgery and minimally invasive surgery, which is a milestone. The stapler can staple tissues through staples while cutting, and is widely used for cutting, suturing or anastomosis of intestines, stomach, lungs, pancreas and other organs and tissues. However, the rigid staples alone cannot completely avoid the defects, leakage, and bleeding of the anastomotic tissue, which may lead to problems such as infection, stenosis, and scarring. Once complications such as anastomotic leakage, bleeding, stenosis, infection, and adhesion occur, a second surgery may be required, which will seriously affect the patient's quality of life, even endanger their life, and cause serious financial and psychological burdens to the patient.

In order to reduce postoperative complications of anastomosis, the existing method uses a stapler with a biomaterial diaphragm. A layer of absorbable biomaterial diaphragm is installed on both the staple cartridge and the anvil surface of the stapler. When the staple cutting is completed, the biomaterial diaphragm is fixed on the anastomosis to protect fragile tissues from being stapled. Tear, or close the gap between the bare nail and the tissue or blood vessel, thereby strengthening the anastomosis and reducing the risk of complications such as anastomotic leakage and bleeding. The biomaterial diaphragm is a sheet structure made of degradable biomaterials, and the degradable biomaterials may be polymer materials or animal tissue materials. Preferably, the degradable biomaterial can be an animal-derived tissue material that has undergone immunogen removal treatment, such as submucosa material, preferably small intestinal submucosa material, bladder submucosa material; or, for example, organ capsule, preferably pericardium.

However, the existing method requires that the reinforcing patch of the anastomosis needs to be assembled into the staple cartridge part and the anvil part of the stapler. Usually, wires are used to detachably connect the reinforcing patch and the backing, and then they are assembled together into the stapler. The warehouse and the anvil. 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.

In addition, after the reinforcement patch is fixed to the tissue to be treated, the wire can be removed to release the fixation between the reinforcement patch and the backing, thereby removing the backing. However, the use of wires to fix the biomaterial layer and backing makes the structure of the reinforced patch complex. Special placement and fixation are required to cooperate with the stapler to ensure that the wires will not become knotted or messy, which increases the time in the product production process. The process steps in the process affect production efficiency and product yield.

In addition, since the staples need to completely cover the contact area between the reinforced patch and the tissue, the total length of the stapled reinforced patch along the anastomosis needs to be greater than the length of the patch. In other words, the distal length of the anastomosis line is longer than the length of the cutting line. However, with the structure of the existing reinforced patch patch, the cutting knife is likely to be unable to cut off the patch patch, and other cutting tools are required to complete the cutting, which increases the complexity of the operation.

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 and solve the above problems.

Contents of the invention

The present disclosure provides an anastomotic reinforcing patch, which is configured to be used in conjunction with a staple cartridge assembly and/or an anvil assembly of a stapler. The anastomotic reinforcing patch includes:

A biomaterial membrane including a main body and a protrusion extending outwardly from the main body; and

a backing, the backing being detachably connected to the biomaterial membrane to form a first sleeve structure or a second sleeve structure;

Wherein, the protruding portion is configured to guide the end of the nail cartridge assembly and/or the nail anvil assembly when the anastomotic reinforcing patch is assembled to the nail cartridge assembly and/or the nail anvil assembly. Extend into the first socket structure and/or the second socket structure.

In some embodiments, the biomaterial membrane further includes an extension extending outward from the main body, and one end of the biomaterial membrane is provided with a cutout; and

One end of the backing is provided with a cap portion, and the cap portion has a receiving space for receiving the extension portion.

In some embodiments, the anvil assembly of the stapler is provided with a stop structure; the protrusion is configured to extend into a space formed by the stop structure, the staple cartridge assembly, and the anvil assembly. within the space.

In some embodiments, the protrusion is configured to cover the staple holes in the space formed by the staple cartridge assembly at the stop structure.

In some embodiments, the protrusion has an arcuate outer edge profile.

In some embodiments, the distal-most end of the protrusion extends outwardly in the length direction of the body beyond the suture end of the wire.

In some embodiments, the main body part has a length direction and a width direction, and the width of the protruding part along the width direction is smaller than the width of the main body part.

In some embodiments, when the anastomotic reinforcing patch is used in conjunction with the staple cartridge assembly of the stapler, the protrusion guides the first end of the staple cartridge assembly of the stapler so that It extends into the first sleeve structure, and the protrusion covers the surface of the staple cartridge assembly in the space formed at the stop structure.

In some embodiments, when the anastomotic reinforcement patch is used in conjunction with an anvil assembly of the stapler, the protrusion guides the first end of the anvil assembly of the stapler so that It extends into the second sleeve structure, and the protrusion covers the surface of the anvil assembly in the space formed at the stop structure.

In some embodiments, the anastomosis reinforcing patch further includes a guide port, and the guide port is provided on the main body part and at least a part of the protruding part.

The present disclosure also provides a surgical device, which includes:

A stapler including a staple cartridge assembly and an anvil assembly; and

The anastomotic reinforcing patch as described in any one of the above items is used in conjunction with the stapler.

The present disclosure also provides an anastomotic reinforcing patch, which is configured to be used in conjunction with the staple cartridge assembly and/or the staple anvil assembly of the stapler. The anastomotic reinforcing patch includes:

A biomaterial membrane, which includes a main body and an extension extending outward from the main body, and one end of the biomaterial membrane is provided with a cutout; and

A backing is detachably connected to the biomaterial membrane. One end of the backing is provided with a cap portion, and the cap portion has a receiving space for receiving the extension portion.

In some embodiments, where the anastomotic reinforcement patch is used in conjunction with a staple cartridge assembly of the stapler, at least a portion of the extension is inserted into the cap, and the biomaterial membrane is The sheet and the backing are removably sutured with wires to form a first socket structure, and the first socket structure is socketed to the staple cartridge assembly of the stapler to form anastomosis reinforcement and repair in the first use state. piece.

In some embodiments, it further includes:

In the case where the anastomotic reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension is inserted into the cap and the biomaterial membrane is attached to the backing The second sleeve structure is formed by detachable suture with wire, and the second sleeve structure is sleeved with the anvil assembly of the stapler to form the anastomosis reinforcement patch in the second use state.

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

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

In some embodiments, the cutout is provided on the extension part and partially on the main body part;

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

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

In some embodiments, a centerline of the guide opening in the length direction of the biomaterial membrane coincides with a centerline of the incision in the length direction of the biomaterial membrane.

In some embodiments, the biomaterial membrane further includes a protrusion extending outwardly from the main body; and

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

The protruding portion is configured to guide the end of the nail cartridge assembly and/or the nail anvil assembly to extend into The first socket structure and/or the second socket structure.

The present disclosure also provides a surgical device, which includes:

A stapler including a staple cartridge assembly and an anvil assembly; and

In some embodiments, it also includes:

In the case where the anastomosis reinforcing patch is used in conjunction with the staple cartridge assembly of the stapler, at least a portion of the extension is inserted into the cap, and the biomaterial membrane is attached to the backing The first sleeve structure is formed by detachable suture with wires, and the first sleeve structure is sleeved with the staple cartridge assembly of the stapler to form the anastomosis reinforcement patch in the first use state; and/or

Compared with related technologies, the present disclosure has at least the following technical effects:

Compared with the prior art, the anastomotic reinforcing patch of the present invention utilizes at least part of the extension of the biomaterial membrane by providing an extension on the biomaterial membrane and providing a receiving space on the backing to accommodate the extension. The cap part of the backing is pluggable and removable to form a socket structure, which can effectively avoid incorrect operations such as the biomaterial diaphragm not being assembled into the predetermined position of the backing, or the biomaterial diaphragm protruding from the structural gap in the backing. Problems or assembly misalignment problems, the anastomosis can also be reinforced, repaired and anastomotic directly after cutting; by setting an incision on the biomaterial diaphragm, the incision limits the cutting component of the stapler when cutting the tissue to be processed. The position is such 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 the anastomosis. Perfect fit eliminates the need for additional cutting tools and improves ease of operation.

In addition, by providing a guide opening in the reinforced patch, the shearing force of the cutting assembly when cutting the patch can be reduced, and the risk of unfavorable cutting caused by curling of the patch can be avoided.

Description of the drawings

In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, a brief introduction will be made below to the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description These are some embodiments of the present disclosure. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without exerting creative efforts.

Figure 1 is a schematic three-dimensional structural diagram of an example of an anastomotic reinforcement patch provided by the present disclosure;

Figure 2 is an exploded view of the three-dimensional structure of an example of the anastomotic reinforcement patch in Figure 1;

Figure 3 is an exploded view of the three-dimensional structure of an application example of the anastomotic reinforcement patch in Figure 1;

Figure 4 is a schematic diagram of another example of the anastomotic reinforcement patch of Figure 1;

Figure 5 is a three-dimensional structural view of another example of the anastomotic reinforcement patch provided by the present disclosure;

Figure 6 is an exploded view of the three-dimensional structure of the anastomotic reinforcement patch in Figure 5;

Figure 7 is a schematic three-dimensional structural diagram of another application example of the anastomotic reinforcement patch in Figure 5;

Figure 8 is a schematic diagram of another example of the anastomotic reinforcement patch of Figure 5;

Figure 9 is a schematic three-dimensional structural diagram of another application example of the anastomotic reinforcement patch provided by the present disclosure.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present disclosure clearer, the present disclosure will be described in further detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present disclosure. Based on the embodiments in this disclosure, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of this disclosure.

The terminology used in the embodiments of the present disclosure is for the purpose of describing particular embodiments only and is not intended to limit the disclosure. As used in the embodiments of this disclosure and the appended claims, the singular forms "a," "the," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. Usually contains at least two kinds.

It should be understood that the term "and/or" used in this article is only an association relationship describing related objects, indicating that there can be three relationships, for example, A and/or B, which can mean: A alone exists, and A and A exist simultaneously. B, there are three situations of B alone. In addition, the character "/" in this article generally indicates that the related objects are an "or" relationship.

It should also be noted that the terms "comprises", "comprises" or any other variation thereof are intended to cover a non-exclusive inclusion, such that a good or apparatus including a list of elements includes not only those elements but also those not expressly listed other elements, or elements inherent to such goods or devices. Without further limitation, an element defined by the statement "comprises a" does not exclude the presence of other identical elements in the goods or devices including the stated element.

The present disclosure provides an anastomotic reinforcing patch, which is configured to be used in conjunction with a staple cartridge assembly and/or an anvil assembly of a stapler. The anastomotic reinforcing patch includes: a biomaterial diaphragm, which includes a main body; an extension extending outward from the main body, one end of the biomaterial diaphragm is provided with a cutout; and a backing detachably connected to the biomaterial diaphragm, one end of the backing is provided with a cap, so The cap part has a receiving space for receiving the extension part.

Using the anastomotic reinforcement patch provided by the present disclosure, by providing an extension part on the biomaterial diaphragm, and providing a receiving space with accommodating the extension part on the backing, at least part of the extension part of the biomaterial diaphragm can be pluggably accommodated in the patch. The cap part of the backing forms a socket structure, which can effectively avoid misoperation or assembly misalignment problems such as the biomaterial diaphragm not being assembled to the predetermined position of the backing, or the biomaterial diaphragm protruding from the structural gap in the backing. , it is also possible to perform reinforcement, repair and anastomosis of the anastomosis directly after cutting; by setting an incision on the biomaterial diaphragm, the cutting position of the cutting component of the stapler is limited through the incision when cutting the tissue to be processed, so that the cutting The position reached by the first end of the 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 matched without the need for Using additional cutting tools improves ease of operation.

In addition, by providing a guide opening in the reinforced patch, the shearing force of the cutting assembly when cutting the patch can be reduced, and the risk of unfavorable cutting caused by curling of the patch can be avoided. .

It should be noted that the anastomotic reinforcement patch of the present invention is widely used, and is particularly suitable for application scenarios of staplers that place the reinforcement patch at designated locations and fix the reinforcement patch, such as the intestines, stomach, lungs, pancreas, etc. Application scenarios for cutting, suturing or anastomosis of organs and tissues. Optional embodiments of the present disclosure are described in detail below with reference to the accompanying drawings.

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 anastomosis, the structure of each component in the anastomosis reinforcement patch was improved, so that the stapler can Precise positioning and cutting can be achieved during operations such as cutting and anastomosis, effectively preventing the anastomosis from being closed or tearing after anastomosis, the reinforcement patch not being assembled to the predetermined position on the backing, or the reinforcement patch slipping from the backing. Various problems caused by protruding from the gap in the middle structure and being unable to cut off the patch during cutting can achieve a more effective anastomotic anastomosis. The improved structure of the present invention will be described in detail below.

Figure 1 is a schematic three-dimensional structural diagram of an example of an anastomotic reinforcement patch provided by the present disclosure.

As shown in Figure 1, the present disclosure provides an anastomotic reinforcement patch 10. The anastomosis reinforcement patch 10 (in this embodiment, also referred to as the first anastomosis reinforcement patch 10) includes a first biological material membrane 11 and a first backing 13 detachably connected to the first biomaterial membrane 11 .

Specifically, the first biomaterial membrane 11 and the first backing 13 are preferably detachably connected through a wire 60 . Specifically, the wire 60 connects the first biomaterial membrane 11 along the length direction of the first biomaterial membrane 11 . The two sides in the width direction of 11 and the two sides in the width direction of the first backing 13 are detachably connected, see Figure 1 .

Optionally, the first biomaterial membrane 11 is used for various soft tissue repair clinical operations, etc. For example, when using a stapler to process the tissue to be treated or suturing using, for example, staples, the first biomaterial membrane 11 is detached from the first backing 11 and the second backing 21 respectively to fix and repair the tissue to be treated. At the anastomosis, the first biomaterial diaphragm 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.

It should be noted that in the present invention, the first biomaterial membrane is, for example, an in vivo degradable polymer material or an in vivo degradable biological material, where the polymer material includes, for example, polypropylene, polylactic acid (PLA), polyhydroxyl Acetic acid (PGA) or polylactic acid glycolic acid (PLGA), etc.

FIG. 2 is an exploded view of the three-dimensional structure of an example of the anastomotic reinforcement patch in FIG. 1 .

As shown in FIG. 2 , the first biomaterial membrane 11 includes a first main body part 111 and a first extension part 113 extending outward from the main body part 111 . One end of the first biomaterial membrane 11 is provided with a first extension part 113 . A cutout 115 is made, wherein the first main body part 111 is generally strip-shaped, and the orthographic projection on a plane parallel to the horizontal plane is generally rectangular. However, it is not limited to this. In other examples, the above-mentioned orthographic projection can also be Bevel a rectangle or other polygonal shape. The above are only described as optional examples and should not be construed as limitations of the present invention.

It should be noted that in the present invention, the end of the component or component on the left side of the drawing is called the first end, and the end of the component or component on the right side of the drawing (that is, the end opposite to the first end) is called the first end. One end) is called the second end, the upper side of the drawing is called the upper side, and the lower side of the drawing is called the lower side.

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 a portion from the first end of the first main body portion 111 (in this example , formed by the outward extension of the central part). More specifically, the first extension portion 113 is inclined outward from the first main body portion 111 , for example, inclined toward the lower left as shown in FIG. 2 .

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 extending portion, as long as the shape is easy to insert and remove. The above are only described as optional examples and should not be construed as limitations of the present invention.

In the example shown in FIG. 2 , the first cutout 115 is provided on the first extension part 113 and partially on the first main body part 111 , and the first cutout 115 is provided along the first extension part 113 . A main body part 111 is arranged in the length direction. As can be seen from FIG. 2 , the first extending portion 113 is divided into two parts by the first cutout 115 .

Furthermore, a first cap part 130 is provided at one end of the first backing 13 , and the first cap part 130 has a receiving space S1 for receiving the first extension part 113 .

Optionally, the depth d1 of the receiving space S1 of the first cap part 130 is less than or equal to the length c of the first extension part 113 in the length direction of the first biomaterial membrane 11 , see FIG. 2 .

Preferably, the depth d1 of the receiving space S1 of the first cap part 130 is less than or equal to 1/2 of the length c of the first extension part 113 in the length direction of the first biomaterial membrane 11 .

It should be noted that the above are only described as optional examples and cannot be understood as limitations of the present invention.

FIG. 3 is an exploded view of the three-dimensional structure of an application example of the anastomotic reinforcement patch in FIG. 1 . Figure 3 shows the situation in which the anastomotic reinforcing patch of the present invention is used in conjunction with the staple cartridge assembly of the stapler. The improved structure of the anastomotic reinforcement patch of the present invention will be further described below with reference to the application example of FIG. 3 .

Referring to FIGS. 1 and 3 , when the first anastomotic reinforcing patch 10 is used in conjunction with the staple cartridge assembly 30 of the stapler 200 , at least a portion of the first extension 113 is inserted into the first cap 130 , and the first biomaterial membrane 11 and the first backing 13 are detachably sutured through the wire 60 to form a first socket structure, and the first socket structure is socketed to the staple cartridge assembly of the stapler 200 30 to form the first anastomotic reinforcement patch in the first use state.

Specifically, by arranging the first cap part 130 on the first backing 13 and setting the depth of the receiving space S1 of the first cap part 130, at least a part of the first extension part 113 is inserted into the first In a cap part 130, that is, the structure of using the first cap part 130 to accommodate the first extension part 113 can effectively ensure that the first biomaterial membrane is inserted into the first cap part.

Further, a part of the first extension part 113 is inserted into the first cap part 130, and the first biomaterial membrane 11 and the first backing 13 are detachably sutured through the wire 60. Forming the first sleeve structure can more effectively ensure that the first biomaterial membrane is inserted into the first cap, thereby more effectively preventing the biomaterial membrane from not being assembled into the predetermined position of the backing, or the biomaterial membrane from being removed from the backing. In case of incorrect operation problems or assembly misalignment problems such as sticking out of the structural gaps in the backing, the anastomosis can also be reinforced, repaired and anastomotic directly after cutting.

In addition, a first cutout 115 is also provided on the first main body part 111. The first cutout 115 is used to cooperate with the cutting component of the stapler 200, and the cutting component is limited by the first cutout 115. When cutting the tissue to be processed, the cutting position is such that the position reached by the first end of the cutting component (that is, the front end that first contacts the tissue to be processed when used) coincides with the preset cutting position, which can ensure that the cutting component is completely cut off. Reinforces the patch while ensuring complete fit of the anastomosis without the need for additional cutting tools, thereby improving operational convenience.

FIG. 4 is a schematic diagram of another example of the anastomotic reinforcement patch of FIG. 1 .

The difference between the example of FIG. 4 and the example of FIG. 3 is that the first main body part 111 of the first biomaterial membrane 11 is provided with a first guide opening 117 at the second end opposite to the first end.

Specifically, the first guide opening 117 is a through hole penetrating the first main body 111 , and the first guide opening 117 is aligned with the first cutout 115 along the center line of the length direction of the first main body 111 . The center lines of the main body portion 111 in the longitudinal direction coincide with each other. The first guide port 117 is used to guide the cutting component of the stapler to perform the cutting operation, which can reduce the shearing force of the cutting component when cutting the patch and avoid the risk of unfavorable cutting caused by curling of the patch.

It should be noted that since the structure of the first backing in the example of FIG. 4 is substantially the same as that of the first backing in FIG. 1 , description of the same parts is omitted.

An anastomosis reinforcing patch according to another example of the present invention will be described with reference to FIGS. 5 to 9 .

It should be noted that in this embodiment, the anastomosis reinforcement patch (in this embodiment, also called the second anastomosis reinforcement patch 20) is used in conjunction with the anvil assembly of the stapler. .

Figure 5 is a three-dimensional structural view of another example of the anastomotic reinforcement patch provided by the present disclosure. Figure 6 is an exploded view of the three-dimensional structure of the anastomotic reinforcement patch in Figure 5.

As shown in FIGS. 5 and 6 , the second anastomotic reinforcement patch 20 includes a second biomaterial membrane 21 and a second backing 23 , and the second backing 23 and the second biomaterial membrane 21 are detachably connected. connect.

Optionally, the second biomaterial membrane 21 and the second backing 23 are detachably connected through a wire 61 , specifically the wire 61 connects the second biomaterial membrane 21 along the length direction of the second biomaterial membrane 21 . Both sides in the width direction of 21 and both sides in the width direction of the second backing 23 are detachably connected.

Specifically, the second biomaterial membrane 21 includes a second main body part 211 and a second extension part 213 extending outward from the second main body part 211. The second extension part 213 is formed by the second cutout. 215 is divided into two parts, that is, the second extension part 213 is two protruding parts protruding outward from the second main body part 213 .

Furthermore, a second cap part 230 is provided at one end (ie, the first end) of the second backing 23 , and the second cap part 230 has a receiving space S2 for receiving the second extension part 213 .

Optionally, the depth d2 of the receiving space S1 of the second cap part 230 is less than or equal to the length c2 of the second extension part 213 in the length direction of the second biomaterial membrane 11 , see FIG. 6 .

Preferably, the depth d2 of the receiving space S1 of the second cap part 230 is less than or equal to 1/2 of the length c2 of the second extension part 213 in the length direction of the second biomaterial membrane 11 .

During assembly and use, at least a part of the second extension part 213 is inserted into the second cap part 230 , and the second biomaterial membrane 21 and the second backing 23 are detachably sutured through the wire 61 To form the second socket structure (see 7).

It should be noted that the structures of the second biomaterial membrane 21 and the second backing 23 in the example shown in FIG. 5 are different from the structures of the first biomaterial membrane 11 and the first backing 13 in the example shown in FIG. 1 The functions and preparation materials of the second biomaterial membrane 21 in Embodiment 2 and the first biomaterial membrane 11 in Embodiment 1 are substantially the same. Therefore, the description of the same parts is omitted.

FIG. 7 is a schematic three-dimensional structural diagram of another application example of the anastomotic reinforcement patch in FIG. 5 .

Figure 7 shows the situation in which the anastomosis reinforcing patch of the present invention (ie, the second anastomosis reinforcing patch) is used in conjunction with the anvil assembly of the stapler.

As shown in Figure 7, when the second anastomosis reinforcing patch 20 is used in conjunction with the anvil assembly 40 of the stapler 200, at least a part of the second extension part 213 is inserted into the second cap part 230, and the The second biomaterial membrane 21 and the second backing 23 are detachably sutured through wires 61 to form a second socket structure, and the second socket structure is socketed to the anvil assembly 40 of the stapler 200 To form the anastomotic reinforcement patch in the second use state.

Through the above-mentioned second sleeve structure, it can more effectively ensure that the second biomaterial membrane is inserted into the second cap, thereby more effectively preventing the biomaterial membrane from not being assembled into the predetermined position of the backing, or the biomaterial membrane being inserted into the second cap. In case of incorrect operation problems or assembly misalignment problems such as protruding from the structural gaps in the backing, the anastomosis can also be reinforced, repaired and anastomotic directly after cutting.

Optionally, the length a of the second cutout 215 in the length direction of the second body part 211 is less than 1/2 of the length b of the second body part 211 in the length direction. See FIG. 8 for details.

Preferably, the length a of the second cutout 115 in the length direction of the second body part 211 is less than 1/2 of the length b of the second body part 211 in the length direction.

By setting the second incision and its length, the cutting assembly can further ensure that the reinforcing patch is completely cut off, and at the same time, the anastomosis can be completely matched without using additional cutting tools, thereby improving operational convenience.

FIG. 8 is a schematic diagram of another example of the anastomotic reinforcement patch of FIG. 5 .

The difference between the example of FIG. 8 and the example of FIG. 5 is that the second main body part 211 of the second biomaterial membrane 21 is provided with a second guide opening 217 at the second end opposite to the first end.

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 .

Furthermore, the center line of the second guide opening 217 along the length direction of the second main body part 211 coincides with the center line of the second cutout 215 along the length direction of the second main body part 211 . The second guide port 217 is used to guide the cutting component of the stapler to perform the cutting operation, which can further reduce the shearing force of the cutting component when cutting the patch and avoid the risk of unfavorable cutting caused by curling of the patch.

Another embodiment of the present disclosure also provides an anastomotic reinforcing patch 10, as shown in Figures 1-4 and 9, which is configured to be used in conjunction with the staple cartridge assembly 30 of the stapler. The anastomosis reinforcing patch 10 includes: a biomaterial membrane 11, which includes a first main body part 111 and a first protruding part 112 extending outward from the first main body part 111; and a backing 13, the backing 13 13 is detachably connected to the biomaterial membrane 11 to form a first sleeve structure.

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

In some embodiments, as shown in FIGS. 1-2 , the distal end of the first protruding portion 112 extending outward from the first main body portion 111 of the biomaterial membrane 11 of the present disclosure exceeds the wire 60 in the length direction. suture endpoint.

In some embodiments, the first main body part 111 has a length direction and a width direction, and the maximum width of the first protruding part 112 along the width direction is smaller than the maximum width of the main body part 111 .

In some embodiments, the first protruding portion 112 is configured to guide the end of the staple cartridge assembly 30 to extend into the anastomotic reinforcing patch 10 when the staple cartridge assembly 30 is assembled. The first socket structure.

In some embodiments, as shown in FIG. 3 , the first protruding portion 112 enters the space formed by the stop structure 41 and can cover the surface of the nail cartridge assembly and/or the nail anvil assembly in the space to avoid completing the anastomosis. Exposed titanium nails will be formed after the weapon is fired. That is to say, if there is no coverage by the first protrusion 112, there is a risk that some titanium nail holes will not be covered by the biological patch.

In some embodiments, as shown in FIGS. 1-2 , the first protrusion 112 may have an arc-shaped outer edge profile.

In some embodiments, when the anastomosis reinforcing patch 10 is used in conjunction with the staple cartridge assembly 30 of the stapler, the first protrusion 112 guides the staple cartridge assembly 30 of the stapler. The first end of the nail cartridge assembly 30 extends into the first sleeve structure, and the first protrusion 112 covers the surface of the staple cartridge assembly 30 in the space formed at the stop structure 41 .

In some embodiments, as shown in FIG. 4 , the anastomosis reinforcing patch 10 further includes a first guide port 117 , and a part of the first guide port 117 is provided on the first protrusion 112 . The other part of the guide opening 117 is provided on the main body 111 .

Another embodiment of the present disclosure also provides an anastomotic reinforcing patch 20, as shown in Figures 5-9, which is configured to be used in conjunction with the anvil assembly 40 of the stapler. The anastomosis reinforcing patch 20 includes: a biomaterial membrane 21, which includes a second main body part 211 and a second protruding part 212 extending outward from the second main body part 211; and a backing 23, the backing 23 23 is detachably connected to the biomaterial membrane 21 to form a second sleeve structure.

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

In some embodiments, as shown in FIGS. 5-6 , the distal 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 wire 61 in the length direction. suture endpoint.

In some embodiments, the second main body part 211 has a length direction and a width direction, and the maximum width of the second protruding part 212 along the width direction is smaller than the maximum width of the main body part 211 .

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

In some embodiments, as shown in Figures 5 and 7, the second protrusion 212 enters the space formed by the stop structure 41 and can cover the surface of the nail cartridge assembly and/or the nail anvil assembly in the space, Avoid exposing titanium nails after firing the stapler. That is to say, if there is no coverage by the second protrusion 212, there is a risk that some titanium nail holes will not be covered by the biological patch.

In some embodiments, as shown in FIGS. 5-6 , the second protrusion 212 may have an arc-shaped outer edge profile.

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. The second protruding portion 212 covers the surface of the nail anvil assembly 40 in the space formed at the stop structure 41 .

In some embodiments, as shown in FIG. 8 , the anastomosis reinforcing patch 20 further includes a second guide opening 217 , and a part of the second guide opening 217 is provided on the second protruding portion 212 . The other part of the guide opening 217 is provided on the main body 211 .

The present invention also provides a surgical device, which is used to perform cutting, anastomosis, etc. on the tissue to be treated. The surgical device of the present invention will be described below with reference to Figures 1, 3, 5, 7 and 9.

Specifically, the surgical device includes a stapler 200 and an anastomosis reinforcing patch used in conjunction with the stapler 200 , wherein the stapler 200 includes a staple cartridge assembly 30 and an anvil assembly 40 .

In the first embodiment, the anastomosis reinforcement patch is the first anastomosis reinforcement patch 11 in Embodiment 1. That is, the anastomosis reinforcement patch is only used for socketing the nail cartridge assembly 30. See Figure 3 for details.

As shown in FIG. 3 , when the first anastomosis reinforcement patch 11 is used in conjunction with the staple cartridge assembly 30 of the stapler 200 , at least a part of the first extension part 113 is inserted into the first cap part 130 , and the first extension part 113 is inserted into the first cap part 130 . The first biomaterial membrane 11 and the first backing 13 are removably sutured through wires 60 to form a first sleeve structure, and the first sleeve structure is sleeved on the staple cartridge assembly 30 of the stapler 200 to form The anastomotic reinforcement patch in the first use state.

In addition, a first cutout 115 is also provided on the first main body part 111 , and the first cutout 115 is used in conjunction with the cutting assembly 50 of the stapler 200 .

Specifically, the length of the first cutout 115 in the longitudinal direction of the first main body part 111 is less than 1/2 of the length of the first main body part 111 in the longitudinal direction.

Preferably, the length of the first cutout 115 in the longitudinal direction of the first main body part 111 is less than 1/3 of the length of the first main body part 111 in the longitudinal direction.

The first incision 115 is used to limit the cutting position of the cutting component when cutting the tissue to be treated, so that the first end of the cutting component (that is, the front end that first contacts the tissue to be treated when used) reaches the position. Coinciding with the preset cutting position can ensure that the cutting component completely cuts off the reinforcement patch, and at the same time ensures a complete fit of the anastomosis without the need to use additional cutting tools, thereby improving operational convenience.

It should be noted that since the structure of the first anastomosis-reinforced patch 11 in the first embodiment is substantially the same as that of the first anastomosis-reinforced patch 11 in Embodiment 1, description of the same parts is omitted.

In the second embodiment, the anastomosis reinforcement patch is the second anastomosis reinforcement patch 21 in Embodiment 2. That is, the anastomosis reinforcing patch is only used for socketing the anvil assembly 40. See Figure 7 for details.

As shown in Figure 7, when the second anastomosis reinforcing patch 20 is used in conjunction with the anvil assembly 40 of the stapler 200, at least a part of the second extension part 213 is inserted into the second cap part 230, and the The second biomaterial membrane 21 and the second backing 23 are detachably sutured through wires 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 anastomosis reinforcement patch in the second use state.

It should be noted that since the structure of the second anastomosis-reinforcing patch 20 in the second embodiment is substantially the same as the structure of the second anastomosis-reinforcing patch 21 in the second embodiment, description of the same parts is omitted.

[Correction 30.10.2023 under Rule 91]
In the third embodiment, the anastomosis reinforcement patch includes the first anastomosis reinforcement patch 11 in Embodiment 1 and the second anastomosis reinforcement patch 21 in Embodiment 2, that is, the anastomosis reinforcement patch is used for For socketing the nail cartridge assembly 30 and the nail anvil assembly 40, see Figure 9 for details.

[Correction 30.10.2023 under Rule 91]
As shown in Figure 9, the patch 11 is reinforced at the first anastomosis and used in conjunction with the staple cartridge assembly 30 of the stapler 200, and the patch 20 is reinforced with the anvil assembly 40 of the stapler 200 at the second anastomosis. When used together, the first biomaterial membrane 11 and the first backing 13 are detachably sutured through the wire 60 to form a first sleeve structure, and at the same time, the second biomaterial membrane 21 and the second backing 23 are connected through The wire 61 can be detachably sewn to form a second sleeve structure.

Specifically, at least a part of the first extension part 113 is inserted into the first cap part 130, and the first biomaterial membrane 11 and the first backing 13 are detachably sutured through the wire 60 to form a first sleeve structure. The first sleeve structure is sleeved on the staple cartridge assembly 30 of the stapler 200 to form an anastomotic reinforcing patch in a first use state. Furthermore, at least a part of the second extension part 213 is inserted into the second cap part 230, and the second biomaterial membrane 21 and the second backing 23 are detachably sutured through the wire 61 to form a second sleeve structure. The second sleeve structure is sleeved on the anvil assembly 40 of the stapler 200 to form an anastomosis reinforcing patch in the second use state.

In this third embodiment, the second biomaterial membrane 21 is provided with a second cutout 215 corresponding to the position of the first cutout 115, and the first cutout and the second cutout are jointly connected to the first cutout 215. The cutting component of the stapler cooperates to perform related operations, which can further ensure that the cutting component can completely cut off the reinforcement patch, and at the same time ensure the complete fit of the anastomosis without the need to use additional cutting tools, thereby improving the convenience of operation.

Regarding the lengths of the first cutout 115 and the second cutout 215 , the length of the first cutout 115 in the length direction of the first body part 111 is the same as the length of the second cutout 215 in the length direction of the second body part 211 . are equal in length.

In another embodiment, a first guide opening 117 is provided at a second end of the first main body 111 opposite to the first end, and a first guide opening 117 is provided in the second main body 211 at a position opposite to the first guide opening 117 . The corresponding second guide port 217.

In this embodiment, the center line of the first guide port 117 in the length direction of the first biomaterial membrane 11 (ie, the first main body portion 111 ) is consistent with the center line of the first incision 115 in the first biomaterial membrane 11 (ie, the first main body portion 111 ). The center lines of the material films (ie, the first body portion 111 ) in the length direction coincide with each other. Correspondingly, the center line of the second guide opening 217 in the length direction of the second biomaterial membrane 21 (ie, the second main body portion 211 ) is consistent with the center line of the second cutout 215 in the second biomaterial membrane 21 . (That is, the center lines in the longitudinal direction of the second main body part 211) coincide with each other.

Compared with the prior art, the surgical device of the present invention improves the structure of the anastomotic reinforcement and modification piece, which can effectively prevent the biomaterial diaphragm from not being assembled to the predetermined position of the backing, or the biomaterial diaphragm from being deformed from the backing. In order to prevent incorrect operation problems such as protrusion from gaps or assembly misalignment problems, the anastomosis can also be reinforced, repaired and anastomotic directly after cutting; the cutting position of the stapler's cutting component during the cutting process of the tissue to be processed is limited through 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 the completeness of the anastomosis Fitting without using additional cutting tools can improve operational convenience; by setting a guide port on the reinforced patch, the shearing force of the cutting component when cutting the patch can be reduced, and the risk of unfavorable cutting caused by curling of the patch can be avoided. .

Finally, it should be noted that each embodiment in this specification is described in a progressive manner. Each embodiment focuses on its differences from other embodiments. The same and similar parts between various embodiments can be referred to each other. As for the system or device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple. For relevant details, please refer to the description in the method section.

The above embodiments are only used to illustrate the technical solutions of the present disclosure, but not to limit them; although the present disclosure has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still make changes to the foregoing embodiments. The recorded technical solutions may be modified, or some of the technical features thereof may be equivalently replaced; however, these modifications or substitutions shall not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of each embodiment of the present disclosure.

Claims

An anastomosis reinforcement patch configured to be used in conjunction with the staple cartridge assembly and/or the staple anvil assembly of a stapler, characterized in that the anastomosis reinforcement patch includes:

A biomaterial membrane including a main body and a protrusion extending outwardly from the main body; and

a backing, the backing being detachably connected to the biomaterial membrane to form a first sleeve structure or a second sleeve structure;

Wherein, the protruding portion is configured to guide the end of the nail cartridge assembly and/or the nail anvil assembly when the anastomotic reinforcing patch is assembled to the nail cartridge assembly and/or the nail anvil assembly. Extend into the first socket structure and/or the second socket structure.
The anastomotic reinforcement patch according to claim 1, wherein

The biomaterial membrane also includes an extension extending outward from the main body, and one end of the biomaterial membrane is provided with a cutout; and

One end of the backing is provided with a cap portion, and the cap portion has a receiving space for receiving the extension portion.
The anastomotic reinforcing patch according to claim 1 or 2, wherein the anvil assembly of the stapler is provided with a stop structure; the protrusion is configured to extend into the space between the stop structure and the in the space formed by the nail cartridge assembly and the nail anvil assembly.
The anastomotic reinforcement patch according to claim 3, wherein the protrusion is configured to cover the nail hole in the space formed by the nail cartridge assembly at the stop structure.
The anastomotic reinforcing patch according to claim 1 or 2, wherein the protruding portion has an arc-shaped outer edge profile.
The anastomotic reinforcement patch according to claim 1 or 2, wherein the distal end of the protrusion extends outward beyond the suture end point of the wire in the length direction of the main body.
The anastomotic reinforcing patch according to claim 1 or 2, wherein the main body part has a length direction and a width direction, and the width of the protruding part along the width direction is smaller than the width of the main body part.
The anastomotic reinforcement patch according to claim 1 or 2, wherein,

When the anastomotic reinforcing patch is used in conjunction with the staple cartridge assembly of the stapler, the protruding portion guides the first end of the staple cartridge assembly of the stapler to extend into the third A sleeve structure is provided, and the protruding portion covers the surface of the staple cartridge assembly in the space formed at the stop structure.
The anastomotic reinforcement patch according to claim 1 or 2, wherein,

When the anastomotic reinforcing patch is used in conjunction with the anvil assembly of the stapler, the protruding portion guides the first end of the anvil assembly of the stapler to extend into the third Two socket structures, and the protruding portion covers the surface of the nail anvil assembly in the space formed at the stop structure.
The anastomosis-reinforcing patch according to claim 1 or 2, wherein the anastomosis-reinforcing patch further includes a guide port, and the guide port is provided on at least a part of the main body part and the protruding part.
A surgical device, characterized in that the surgical device includes:

A stapler including a staple cartridge assembly and an anvil assembly; and

The anastomotic reinforcing patch according to any one of claims 1 to 10, used in conjunction with the stapler.
An anastomosis reinforcement patch configured to be used in conjunction with a staple cartridge assembly and/or an anvil assembly of a stapler, characterized in that the anastomosis reinforcement patch includes:

A biomaterial membrane, which includes a main body and an extension extending outward from the main body, and one end of the biomaterial membrane is provided with a cutout; and

A backing is detachably connected to the biomaterial membrane. One end of the backing is provided with a cap portion, and the cap portion has a receiving space for receiving the extension portion.
The anastomotic reinforcing patch according to claim 12, wherein,

In the case where the anastomosis reinforcing patch is used in conjunction with the staple cartridge assembly of the stapler, at least a portion of the extension is inserted into the cap, and the biomaterial membrane is attached to the backing The first sleeve structure is formed by detachable suture with wire, and the first sleeve structure is sleeved with the staple cartridge component of the stapler to form the anastomosis reinforcement patch in the first use state.
The anastomotic reinforcing patch according to claim 12, wherein,

In the case where the anastomotic reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension is inserted into the cap and the biomaterial membrane is attached to the backing The second sleeve structure is formed by detachable suture with wire, and the second sleeve structure is sleeved with the anvil assembly of the stapler to form the anastomosis reinforcement patch in the second use state.
The anastomotic reinforcement patch according to claim 13 or 14, wherein,

The depth of the receiving space of the cap part is less than or equal to the length of the extension part in the length direction of the biomaterial membrane.
The anastomotic reinforcing patch according to claim 12, wherein,

The extension part is formed by extending outward from a part of the first end of the main body part.
The anastomotic reinforcing patch according to claim 12 or 16, wherein,

The cutout is provided on the extension part and partially on the main body part;

The incision is used to cooperate with the cutting component of the stapler so that the position reached by the front end of the cutting component coincides with the preset cutting position.
The anastomosis reinforcing patch according to claim 12, wherein the main body portion is provided with a guide opening at a second end opposite to the first end.
The anastomosis reinforcing patch according to claim 18, wherein the center line of the guide port in the length direction of the biomaterial membrane is exactly the same as the center line of the incision in the length direction of the biomaterial membrane. center lines coincide.
The anastomotic reinforcement patch according to any one of claims 12-19, wherein

The biomaterial membrane further includes a protrusion extending outwardly from the main body; and

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

The protruding portion is configured to guide the end of the nail cartridge assembly and/or the nail anvil assembly to extend into The first socket structure and/or the second socket structure.
A surgical device, characterized in that the surgical device includes:

A stapler including a staple cartridge assembly and an anvil assembly; and

The anastomotic reinforcement patch according to any one of claims 1-10 or 12-20, which is used in conjunction with the stapler.
The surgical device of claim 21, further comprising:

In the case where the anastomosis reinforcing patch is used in conjunction with the staple cartridge assembly of the stapler, at least a portion of the extension is inserted into the cap, and the biomaterial membrane is attached to the backing The first sleeve structure is formed by detachable suture with wires, and the first sleeve structure is sleeved with the staple cartridge assembly of the stapler to form the anastomosis reinforcement patch in the first use state; and/or

In the case where the anastomotic reinforcement patch is used in conjunction with the anvil assembly of the stapler, at least a portion of the extension is inserted into the cap and the biomaterial membrane is attached to the backing The second sleeve structure is formed by detachable suture with wire, and the second sleeve structure is sleeved on the anvil assembly of the stapler to form the anastomosis reinforcement patch in the second use state.