WO2018121170A1

WO2018121170A1 - Anastomotic stoma reinforcement assembly and method for using same

Info

Publication number: WO2018121170A1
Application number: PCT/CN2017/113791
Authority: WO
Inventors: 赵博; 王洪权; 赵延瑞; 费福垒; 李学军; 张晋辉; 孙丹丹
Original assignee: 北京博辉瑞进生物科技有限公司
Priority date: 2016-12-26
Filing date: 2017-11-30
Publication date: 2018-07-05
Also published as: CN106821438A; CN106821438B

Abstract

Disclosed are an anastomotic stoma reinforcement assembly (1) and a method for using same. The anastomotic stoma reinforcement assembly (1) comprises an anastomotic stoma reinforcement member (2), a supporting member (3) and a fixing member (4), wherein the anastomotic stoma reinforcement member (2) is arranged on at least a part of an outer surface of the supporting member (3) in a bent manner, and the fixing member (4) fixes the anastomotic stoma reinforcement member (2) onto the supporting member (3). The anastomotic stoma reinforcement assembly (1) can not only provide, for a tissue to be treated, a sufficient strength to prevent a suture from tearing, but also completes an anastomotic operation on a cartridge face and an anvil face of an anastomotic/closure device (5) without being limited by an operation space. By means of the method for using the anastomotic stoma reinforcement assembly (1), a reinforcement layer (2a) can be stuck to an anastomotic/closure operation surface in one process, thus simplifying the surgical process and facilitating operations.

Description

Anastomotic joint reinforcement assembly and use method thereof

Technical field

The present invention relates to the field of medical medical devices; and more particularly to an anastomotic reinforcement assembly and method of use thereof.

Background technique

Surgical reinforcement devices reduce the risk of such surgical procedures to a large extent because they can be quickly cut at the same time and with tissues and organs in a closed patient, compared to conventional scalpels/cutting. And shortened the operation time, so it has a very wide range of applications in surgery. A typical surgical reinforcement device has a jaw structure that typically includes two separate arms with an internal face that is a work surface with a staple cartridge face and an anvil face. The surgical reinforcement device may or may not have a cutting device with a cutting action.

In a typical kiss/closer procedure, the staple cartridge face and the anvil face are positioned to the pre-cut tissue and then tightly locked together. The user operates the kiss/closer through an action process, which simultaneously completes the stitching of two or more staple lines onto the tissue and forms a cut line in the middle of the suture. In this way, the operator can complete the rapid stitching and cutting of the tissue simultaneously. This procedure is much faster than using a surgical scissors/knife in a conventional procedure and then suturing the suture at the incision. The advantage of this kind of surgery is that the bleeding time of the wound is reduced, the time of the whole operation is shortened, and the patient care is obviously improved.

In some procedures, the use of bare nails directly means that the staples are in direct contact with the patient's tissue. Because the patient's intact tissue itself prevents the staples from escaping from the combination and compensates for the fracture before healing. However, for other operations, the tissue that the patient needs to suture is too fragile to fix the staples in place. For example, in lung surgery, some lung tissue with special lesions, the tissue that needs to be anastomotic is very fragile. In extreme cases, the unprotected anastomosis line is prone to full-line tearing. With the increasing use of surgical reinforcement devices in diseased lung tissue surgery, it has become increasingly important to take measures to protect fragile tissue from being torn by staples or torn during surgical suturing. Furthermore, when the kiss/closer is used, the leakage around the staples needs to be considered.

Usually the face of the kiss/closer is flat, however there is also a kiss/closer (CN105078528A) in the prior art which has a non-planar anvil face and a staple face. Since for such a non-planar stapler, the shape change is easy to occur when the layer is fixed at the time of installation, and stress is generated between different parts of the reinforcement layer, which is disadvantageous for the installation of the reinforcement layer; or the reinforcement layer and the staple cartridge or during the installation process or The working surface of the anvil is not tightly coupled, which causes the reinforcement layer to fall off and problems occur.

Summary of the invention

The technical problem to be solved by the present invention is to provide an anastomosis reinforcement assembly, which can not only provide sufficient strength for the tissue to be treated, prevent the suture from tearing, but also can be kissed/closed. The staple cartridge surface and the nail anvil surface of the device complete the anastomosis operation, and are not restricted by the operation space.

The technical solution adopted by the present invention is to provide an anastomosis reinforcement assembly comprising an anastomotic reinforcement, a support member and a fixing member, wherein the anastomotic reinforcement is disposed in a bent manner On at least a portion of the outer surface of the support, the fastener secures the anastomotic reinforcement to the support.

Preferably, the anastomotic reinforcement comprises a first reinforcement portion, a second reinforcement portion and a third reinforcement portion, wherein the two ends of the third reinforcement portion are respectively connected to one end of the first reinforcement portion and one end of the second reinforcement portion. The anastomotic reinforcement includes a peelable layer, a bonding layer, and one or more reinforcing layers.

Preferably, the minimum width of the first reinforcement portion and the second reinforcement portion are both greater than the minimum width of the third reinforcement portion. Preferably, the third reinforcement portion (23) is provided with one or more slits inside and/or to the sides. Any slight mismatch in the process of installing the reinforcement layer may cause stress between the first reinforcement portion and the second reinforcement portion, and when the third reinforcement portion has no slit, these stresses may be distorted or wrinkled there, thereby affecting The bonding of the reinforcing layer, the invention can reduce the width of the third reinforcing portion, or the slit provided in the third reinforcing portion can be used for releasing and eliminating these stresses, thereby ensuring that the entire first reinforcing portion and the second reinforcing portion can be effectively Bonded to the target surface.

Preferably, the shape of the slit is a combination of one or more of a line shape, a rectangle shape, a triangle shape, an arc shape, and a trapezoid shape. One or more slits may be provided inside the third reinforcement, and the slits may be openings or slits. Alternatively, the inner slit and the side slit may be used in combination.

Preferably, one side of the support member is in contact with the opposite side of the surface of the first reinforcement portion where the peelable layer is located, and the back surface of the support member is opposite to the surface of the second reinforcement portion where the peelable layer is located. One end of the support member is opposite to the opposite side of the surface of the third reinforcing portion where the peelable layer is located, and the other end of the support member is connected to the fixing member.

Preferably, the total length of the reinforcing layer of the anastomotic reinforcement is greater than the total length of the adhesive layer and the peelable layer, respectively, and more preferably the total length of the peelable layer is greater than the total length of the adhesive layer; The fastener is at least partially located on the reinforcement layer to secure the anastomotic reinforcement to the support. The fixing member is located between the length edge of the reinforcing layer and the length edge of the peelable layer, so that the fixing member can fix the reinforcing member by clamping the end of the reinforcing layer to facilitate removing the peelable layer from the reinforcing member. .

Preferably, the peelable layer comprises a silicone oil layer and a base layer, and the base layer is made of paper or PET film, and the peelable layer functions to maintain the adhesiveness of the adhesive layer and form between the adhesive layer and the external environment. Isolation ensures that the bonding layer will not bond to an inappropriate location before reuse.

The role of the reinforcement layer is for the target tissue, and the auxiliary stapler is reinforced with sutures to enhance the support and reduce or avoid damage to the target tissue by the staples.

Preferably, the material of the reinforcing layer may also be selected from a sheet-shaped antigen-removing animal-derived extracellular matrix material comprising non-crosslinked collagen fibers, mucopolysaccharides, growth factors and glycoproteins; the material of the reinforcing layer is free of immunogen It can be degraded in vivo and has a three-dimensional network porous structure, which can strengthen the anastomosis.

The material of the reinforcement layer may be any suitable biocompatible material, a collagen support material of a reconstituted or natural source, and the like. Collagen support materials, especially extracellular matrix materials, are of concern to us for their advantages in hemostasis and wound healing. The extracellular matrix material may be derived from the submucosa, the capsule, the dura mater, the pericardium, the peritoneum, the dermal collagen, the muscular basement membrane and the like. In the present invention, a submucosa layer, particularly a submucosa of a warm-blooded animal, is preferred as the material of the reinforcing layer. Optionally, a type of additional crosslinking agent and no crosslinking agent is added, preferably a mammalian submucosal extracellular matrix material that retains the native three dimensional structure. Considering the richness and accessibility of the material source, it is more suitable as an extracellular matrix material for feeding animals such as pigs, cattle and sheep as a source of meat or other products. The porcine small intestine submucosa is a preferred material of the present invention, and the source and treatment method can be referred to Chinese patent ZL201310203603.7.

The extracellular matrix material selectively retains growth factors or other biologically active components of the original tissue. For example, the extracellular matrix material can comprise one or more growth factors, such as basic fibroblast growth factor (FGF-2), transforming growth factor-beta (TGF-beta), epidermal growth factor (EGF), and/or Platelet-derived growth factor (PDGF). Meanwhile, the submucosa or other extracellular matrix material used in the present invention may further comprise biomass such as heparin, heparin sulfate, hyaluronic acid, fibronectin or the like. Thus, in general, extracellular matrix materials may contain a biologically active component that is capable of directly or indirectly inducing cellular responses, such as changes in cell morphology, division, growth, protein or gene expression. In addition, as a supplement or alternative to the native biologically active ingredient, a non-native biologically active substance obtained by recombinant techniques or other methods may also be added to the extracellular matrix material.

Other non-bioabsorbable or biodegradable synthetic polymeric materials such as polytetrafluoroethylene (PTFE, such as GORE-TEX), nylon, PP, polyurethane, silicone, PGA, PLA or polycaprolactone, It can be used as a material for the reinforcing layer in the present invention.

The reinforcing layer in the present invention should not be too thick, because too thick will affect the penetration of the staple; it should not be too thin, too thin to achieve effective reinforcement, limited increase in the strength of the tissue, and can not effectively seal the nail to stop bleeding. If necessary, a reinforcement layer of a multi-layer structure can be used. For example, a multi-layered (ie, two or more layers) collagen material, such as a submucosa or other extracellular matrix material, can be combined to form a multi-layered anastomotic reinforcing material. In particular, two, three, four, five, six, seven, eight or more submucosal or other extracellular matrix materials may be combined to form a multi-layered reinforcement layer.

The bonding layer can be used to form a connection between the working face of the kiss/closer and the reinforcing layer, so that the reinforcing layer can be transported to the target tissue and achieve an anastomosis between the working face of the kiss/closer and the target tissue. Reinforcement of the staple line, preferably, the material of the adhesive layer comprises a protein glue.

Preferably, the support member is capable of providing a support surface of a flat surface, a curved surface, a curved surface or a stepped surface. More preferably, the material of the support is ceramic, metal, rubber or plastic. In general, when the support member is a flat hard or rigid material, for the non-planar anvil surface and the staple cartridge surface of the prior art, the stable installation of the reinforcement layer cannot be ensured, especially for the curved shape and the curved surface shape. In the working face and the stepped working face, the bonding layer on the reinforcing layer cannot be in full contact with the working surface, so that effective bonding cannot be achieved, which may cause the reinforcing layer to fall off. The support layer can be supported by a support that matches the non-planar work surface. The support surface of the support member may be a curved surface, a curved surface or a stepped surface that matches the kiss/closer working surface. In addition, a flexible or elastic material can be used to provide a variable support surface. These materials are planar when there is no external force; when the reinforcement is installed, these materials are deformed by being squeezed, and thus can provide a curved surface, a curved surface or a step surface. Since the fixing member is generally flexible, the reinforcing layer can still be fixed to the supporting member by using the fixing member, in the bonding process, since the surface of the supporting member is the same as the shape of the working surface, and the reinforcing layer and the bonding layer itself are The flexibility can be deformed so that in the case where the anvil and the staple cartridge are clamped, the adhesive layer on the support will be intimately bonded to the anvil and the staple cartridge, thereby ensuring the bond strength.

In the preparation of the reinforcing assembly of the present invention, the adhesive layer may be first applied to the peelable layer, and after drying, the anastomotic reinforcement is attached to the support member to transfer the adhesive layer to the reinforcing layer; The bonding layer is formed on the fixing layer; the bonding layer may be continuously disposed on the surface of the reinforcing layer or may be intermittently disposed on the surface of the reinforcing layer.

With the above structure, an anastomosis-reinforcing assembly of the present invention has the advantage over the prior art that the anastomotic reinforcement is accurately attached to the staple cartridge and/or anvil of the stapler by means of a sticking And with the kiss / closure front end on the body surface or into the body to complete the anastomosis operation. The fixation between the anastomotic reinforcement and the kiss/closer is done in free space, independent of the operating space. Moreover, the assembled anastomotic reinforcement does not move relative to the kiss/closer movement.

Another object of the present invention is to provide a method of using an anastomosis-reinforcing assembly that can bond a reinforcing layer to a kiss/closed working surface at one time, simplifying the surgical procedure and facilitating handling.

The technical solution adopted by the present invention is to provide a method for using an anastomotic reinforcement assembly which adheres a reinforcement layer to a kiss/closer: an anvil and a staple cartridge on an open kiss/closer, and is removed. a peelable layer of the anastomotic reinforcement assembly corresponding to the shape of the kiss/closer staple cartridge and the anvil, placed between the anvil, the opening of the staple cartridge, and aligned with the working surface of the anvil and the staple cartridge, After alignment, the anvil and the staple cartridge are closed, clamped, and the adhesive layer is adhered to the anvil and the staple cartridge, the fixing member is removed, the anvil and the staple cartridge are opened again, and the support member is removed.

Preferably, the bonding of the bonding layer on the kiss/closer anvil and the staple cartridge is a removable connection, and the thickness of the support member can be set according to an allowable thickness between the staple cartridge and the anvil. Preferably, the support has a thickness of 50-1000 micrometers, and in use, the adhesion can be controlled by controlling the coating thickness, so that the bonding of the adhesive layer on the kiss/closer is a removable connection, and the stitching of the reinforcing layer is maintained. The force is above 5N.

The invention provides a reinforcement assembly, wherein the integrally designed reinforcement layer is fixed to the working surface of the staple cartridge and the anvil by a bonding layer at one time to strengthen the fragile tissue during the operation to avoid undesired Damage and leakage. And further, by the arrangement of the structure of the reinforcement layer and the structure of the support member, it is ensured that the reinforcement layer is closely combined with the working surface of the staple cartridge and the anvil.

DRAWINGS

1 is a schematic exploded view of an anastomosis-reinforcing assembly of the present invention;

2 is an anastomotic reinforcement assembly of the present invention and a partially enlarged structural view thereof;

Figure 3 is a schematic illustration of various embodiments of the reinforcement of the present invention;

Figure 4 is a schematic illustration of various embodiments of a support of the present invention;

Figure 5 is a schematic view showing the installation of the anastomosis reinforcement assembly of the present invention;

Among them, 1. anastomosis reinforcement assembly, 2. anastomotic reinforcement, 21. first reinforcement, 22. second reinforcement, 23. third reinforcement, 2a. reinforcement layer, 2b. bonding layer, 2c Peelable layer, 3. Support, 4. Fixing, 5. Kiss/closer, 51. Anvil, 52. Staple.

detailed description

The invention is further described below in conjunction with the drawings and specific embodiments.

As shown in FIG. 1 and FIG. 2, the present invention provides an anastomosis reinforcement assembly 1 comprising an anastomotic reinforcement 2, a support member 3 and a fixing member 4, and the anastomotic reinforcement 2 is matched with the support member 3, and the fixing member 4 Fixing the anastomotic reinforcement 2 to the support member 3, the anastomotic reinforcement 2 includes a first reinforcement portion 21, a second reinforcement portion 22 and a third reinforcement portion 23, and the two ends of the third reinforcement portion 23 are respectively first and One end of the reinforcing portion 21 and one end of the second reinforcing portion 22 are connected, and the anastomosis reinforcing member 1 includes a peelable layer 2c, an adhesive layer 2b, and a reinforcing layer 2a.

One surface of the support member 3 is in contact with the opposite side of the surface of the first reinforcing portion 21 on which the peelable layer 2c is located, and the other surface of the support member 3 is adhered to the opposite side of the surface of the second reinforcing portion 22 where the peelable layer 2c is located, and is supported. One end of the piece 3 is in contact with the opposite side of the surface of the third reinforcing portion 23 on which the peelable layer 2c is located, and the fixing member 4 is fitted over the other end of the support member 3, that is, the reinforcing member 2 and the reinforcing layer 2a of the anastomotic reinforcing member 2. fit.

The total length of the reinforcing layer 2a of the anastomotic reinforcement 2 is greater than the total length of the adhesive layer 2b and the peelable layer 2c, respectively, the total length of the peelable layer 2c is greater than the total length of the adhesive layer 2b, and the fixing member 4 is located on the reinforcing layer 2a. Length edge and peelable Between the length edges of the layer 2c, that is to say the fixing member 4 covers the bonding layer 2b to be fixed to the support member 3. Preferably, the total length of the peelable layer 2c is greater than the total length of the adhesive layer 2b, which is more advantageous for removing the peelable layer 2c.

When the anastomosis reinforcement assembly 1 is mounted on the support member 3, the first reinforcement portion 21 and the second reinforcement portion 22 of the reinforcement layer 2a are deformed, when the third reinforcement portion 23 and the first reinforcement portion 21 and the second reinforcement portion When the width of the portion 22 is the same, the third reinforcing portion 23 will be twisted and wrinkled due to the re-bending after the folding, which causes the first reinforcing portion 21 and/or the second reinforcing portion 22 (especially The third reinforcing portion 23 is not sufficiently tightly coupled to the working surface between the anvil 51 and the staple cartridge 52.

The slit in the third reinforcing portion 23 can solve the above problem. As shown in FIG. 3, the minimum width of the first reinforcement portion 21 and the second reinforcement portion 22 is greater than the minimum width of the third reinforcement portion 23, and the slit is provided as long as the minimum width of the third reinforcement portion 23 is smaller than the first reinforcement. The minimum width of the portion 21 and the second reinforcement portion 22 is capable of releasing stress, reducing or eliminating distortion and wrinkles. One or more slits may be provided inside or on the side of the third reinforcing portion 23, for example, one of a rectangle, a triangle, an arc, a trapezoid, or a combination of a plurality of shapes, and even the slit may be only one or two. A gap. The slit may be provided at both side edges of the third reinforcing portion 23, or may be provided only at one side, or may be used in combination with an inner slit and a side slit.

The surface of the support member 3 may be flat, or may be processed into a curved surface, a curved surface or a step surface according to the shape of the anvil 51 and the staple cartridge 52, as shown in FIG. 4, wherein the middle edge of the step surface may be a chamfered edge; Moreover, the number of steps can be selected according to actual conditions, and the support member 3 can also be any of the examples illustrated in FIG. The material of the support member 3 may be a polymer material, a plastic, a ceramic, a metal or a combination thereof. The thickness of the support member 3 can be set according to the allowable thickness between the anvil 51 and the staple cartridge 52. The thickness of the support member 3 used in the present invention is preferably 50 to 1000 μm, more preferably 100 to 600 μm, and most preferably 100. The support member 3 may also comprise a flexible or resilient material, such as rubber or plastic, at -350 microns. The elastic material is a planar structure when no external force is applied; when the support member 3 is bonded to the anastomotic reinforcing member 2, deformation is caused by the pressing of the anvil 51 and the staple cartridge 52, thereby providing a curved surface, a curved surface or a stepped surface. The support member 3 comprising an elastic material in combination with the stapled annulus reinforcement 2 can assist the adhesive layer 2b of the anastomosis fastener 2 to be sufficiently bonded to the working faces of the anvil 51 and the staple cartridge 52.

Fig. 5 is a schematic view of the case where the reinforcing layer 2a is attached using the anastomosis reinforcing assembly 1. As can be seen in Figure 5, the kiss/close structure of the kiss/closer 5 is a jaw structure including an anvil 51 and a staple cartridge 52. When the anastomosis reinforcement assembly 1 is installed, the anvil 51 and the staple cartridge 52 of the kiss/closer 5 are opened; the peelable layer 2c is removed from the anastomosis reinforcement assembly 1, and placed in the anvil 51 and the staple cartridge Between 52 working faces. The bonding layer 2b is aligned with the working faces of the anvil 51 and the staple cartridge 52 to ensure that the bonding layer 2b can be accurately bonded to the working faces of the anvil 51 and the staple cartridge 52. After the alignment, the anvil 51 and the staple cartridge 52 are closed and clamped, so that the adhesive layer 2b contacts the working faces of the anvil 51 and the staple cartridge 52, and is bonded to each other. Next, the fixing member 4 for fixing the reinforcing layer 2a, the anvil 51 and the staple cartridge 52 are opened again, and the support member 3 is removed. At this time, the reinforcing layer 2a has been bonded to the working surface of the anvil 51 and the staple cartridge 52 of the kiss/closer 5, and is detached from the support member 3, after which the kiss/closer 5 can further perform the kiss/close operation.

The medical device device provided by the present invention can be used for a variety of surgical procedures including, but not limited to, various lung resection procedures, treatment of soft tissue injuries and defects, and various other surgical procedures. The medical device device provided by the present invention can be used for both humans and animals. The medical device device provided by the present invention can be used in various surgical reinforcement devices, and can also be adjusted to the size, size and shape of various suitable surgical reinforcement devices.

The invention is described in the application of a kiss/closer, but the use of the invention is not limited to the field of surgical kiss/closer, but can also be used in other repair fields, and can also be adjusted according to the size, size, amount of adhesive, etc. according to the application. .

The medical device of the present invention can be provided in a sterile package suitable for medical device products. Sterilization can be accomplished by irradiation, ethylene oxide gas or other sterilization techniques, with corresponding selection of materials and properties of the package.

The preferred embodiments of the invention have been described above, but are not to be construed as limiting the claims. The present invention is not limited to the above embodiments, and the specific structure thereof is allowed to vary, and various changes made within the scope of the invention as claimed are within the scope of the invention.

Claims

An anastomotic reinforcement assembly characterized in that the anastomosis reinforcement assembly (1) comprises an anastomotic reinforcement (2), a support (3) and a fixing member (4), the anastomotic reinforcement (2) Provided in a bent manner on at least part of the outer surface of the support (3), the fixing member (4) fixing the anastomotic reinforcement (2) to the support (3).
The anastomosis reinforcement assembly according to claim 1, wherein the anastomotic reinforcement (2) comprises a first reinforcement portion (21), a second reinforcement portion (22) and a third reinforcement portion (23) The two ends of the third reinforcing portion (23) are respectively connected to one end of the first reinforcing portion (21) and one end of the second reinforcing portion (22), and the anastomotic reinforcing member (2) comprises a peelable layer ( 2c), a bonding layer (2b) and one or more reinforcing layers (2a).
The anastomosis reinforcement assembly according to claim 2, wherein the minimum width of the first reinforcement portion (21) and the second reinforcement portion (22) are greater than the minimum of the third reinforcement portion (23) width.
The anastomosis reinforcement assembly according to claim 2, characterized in that the third reinforcement portion (23) is provided with one or more slits inside and/or on the side.
The anastomotic reinforcement assembly according to claim 4, wherein the shape of the slit is a combination of one or more of a linear shape, a rectangular shape, a triangular shape, an arc shape, and a trapezoidal shape.
The anastomosis reinforcement assembly according to claim 2, wherein the total length of the reinforcement layer (2a) of the anastomotic reinforcement (2) is greater than the adhesive layer (2b) and the peelable layer, respectively ( 2c) the total length, preferably the total length of the peelable layer (2c) is greater than the total length of the bonding layer (2b); the fixing member (4) is at least partially located on the reinforcing layer (2a) to The anastomotic reinforcement (1) is fixed to the support (3).
The anastomosis reinforcement assembly according to claim 1, characterized in that the support member (3) is capable of providing a support surface of a plane, a curved surface, a curved surface or a step surface.
The anastomosis reinforcement assembly according to claim 1, characterized in that the material of the support member (3) is ceramic, metal, rubber or plastic.
A method of using an anastomosis-reinforcing assembly according to any one of claims 1-8, characterized in that the method comprises: opening an anvil (51) and a staple cartridge (52) on the kiss/closer (5); Remove the peelable layer (2c) of the anastomosis reinforcement assembly (1), expose the adhesive layer (2b) to be bonded, and place it between the anvil (51) and the opening of the staple cartridge (52). The bonding layer (2b) is aligned with the working surface of the anvil (51) and the staple cartridge (52); after alignment, the anvil (51) and the staple cartridge (52) are closed, clamped, and the bonding layer is 2b) Bonding to the anvil (51), the staple cartridge (52); removing the fixing member (4); opening the anvil (51) and the staple cartridge (52) again, and removing the support member (3).
The method of using according to claim 9, characterized in that the bonding of the bonding layer (2b) on the anvil (51) and the staple cartridge (52) is a removable connection, the support member (3) The thickness of the reinforcing layer (2a) is 50 N or more, and the stitching holding force of the reinforcing layer (2a) is 5 N or more.