CN106821438B - A kind of previous anastomotic reinforces sub-assembly and its application method - Google Patents

Abstract

The invention discloses a kind of previous anastomotic to reinforce sub-assembly and its application method.The previous anastomotic is reinforced sub-assembly and is characterised by：The previous anastomotic, which reinforces sub-assembly (1), includes previous anastomotic reinforcing member (2), support member (3) and fixture (4), the previous anastomotic reinforcing member (2) is arranged in a manner of bending at least part outer surface of the support member (3), and previous anastomotic reinforcing member (2) is fixed on the support member (3) by the fixture (4).Previous anastomotic provided by the invention reinforces sub-assembly can not only provide enough intensity for pending tissue, prevent from suturing mouth tear, but also can complete anastomosis procedure with nail bin face, the nail anvil face of kiss/closer, not limited by operating space.Present invention also offers the application method that the previous anastomotic reinforces sub-assembly, back-up coat can be disposably adhered on the working face of kiss/closure by this method, simplify surgical procedure, easy to operation.

Description

An anastomotic stoma reinforcement assembly and method of use thereof

technical field

The invention relates to the field of medical devices; more specifically, it relates to an anastomotic stoma reinforcement assembly and a method for using the same.

Background technique

Because the surgical reinforcement device can quickly cut and seal the tissues and organs in the patient's body at the same time, it greatly reduces the risk of this type of surgery compared to conventional surgery with a scalpel/cut first. And shorten the operation time, so it has a very wide range of applications in surgical operations. A general surgical reinforcing device has a jaw structure, usually comprising two separate arms, and the inner surface is a working surface, which has a staple cartridge surface and a staple anvil surface. Surgical reinforcing devices may or may not be provided with a cutting device having a cutting action.

In a typical kiss/closer procedure, the cartridge face and anvil face are positioned into pre-cut tissue and locked tightly together. The user operates the kiss/closer through a course of action, synchronously suturing two or more staples to the tissue and forming a cutting line in the middle of the sutures. In this manner, the operator can simultaneously perform rapid stapling and cutting of tissue. This procedure is much faster than conventional surgery where the incision is cut with scissors/knife and then closed with sutures. The benefits of this type of surgery are: less wound bleeding time, shorter overall surgery time, and thus significantly improved patient care.

In some procedures, it is feasible to use bare staples directly, that is, the staples are in direct contact with the patient's tissue. Because the patient's intact tissue itself prevents the staples from falling out of the assembly and compensates for the crack until it heals. However, for other operations, the tissue that the patient needs to suture is too fragile, and it is difficult to fix the staples in place. For example, in lung surgery, some lung tissues with special lesions require anastomosis are very fragile. In extreme cases, unprotected anastomotic lines are prone to tearing across the board. With the increasing use of surgical reinforcement devices during surgery on diseased lung tissue, it has become increasingly important to take steps to protect delicate tissue from being torn by staples or being torn during surgical closure. Furthermore, when a kiss/closer is used, leakage around staples also needs to be considered.

Usually the working surface of the kiss/closer is plane, but there is also a kiss/closer (CN105078528A) in the prior art, which has a non-planar anvil surface and a staple cartridge surface. For this non-planar stapler, the shape of the reinforcement layer is prone to change during installation and stress is generated between different parts of the reinforcement layer, which is not conducive to the installation of the reinforcement layer; The working surface of the nail anvil is not tightly combined, which causes the reinforcement layer to fall off, causing problems.

Contents of the invention

The technical problem to be solved by the present invention is to provide an anastomotic stoma reinforcement assembly. The anastomotic stoma reinforcement assembly of the present invention can not only provide sufficient strength for the tissue to be treated and prevent the suture stoma from tearing, but also can be combined with anastomosis/closure The anastomosis operation can be completed on the staple cartridge surface and the anvil surface of the device without being limited by the operating space.

The technical solution adopted by the present invention is to provide an anastomotic stoma reinforcement assembly, the anastomotic stoma reinforcement assembly includes an anastomotic stoma reinforcement, a support and a fixing piece, and the anastomotic stoma reinforcement is arranged on the anastomotic stoma in a bent manner. On at least a portion of the outer surface of the support, the fastener secures the stoma reinforcement to the support.

Preferably, the anastomotic stoma reinforcement includes a first reinforcement part, a second reinforcement part and a third reinforcement part, and the two ends of the third reinforcement part are respectively connected to one end of the first reinforcement part and one end of the second reinforcement part , the anastomotic stoma reinforcement includes a peelable layer, an adhesive layer and one or more reinforcement layers.

Preferably, the minimum widths of the first reinforcement part and the second reinforcement part are larger than the minimum width of the third reinforcement part. Preferably, one or more cutouts are provided inside and/or on the sides of the third reinforcing part (23). Any slight mismatch during the installation of the reinforcement layer has the potential to create stresses between the first and second reinforcements which, when the third For the bonding of the reinforcement layer, the present invention can be used to release and eliminate these stresses by reducing the width of the third reinforcement part, or the slit provided at the third reinforcement part, thereby ensuring that the entire first reinforcement part and the second reinforcement part can be effectively bonded to the target surface.

Preferably, the shape of the cutout is a combination of one or more shapes among linear, rectangular, triangular, arc, and trapezoidal. One or more cutouts, which may be openings or slits, may be provided inside the third reinforcing portion. Optionally, an internal cutout and a side cutout can be used in combination.

Preferably, one side of the support member is bonded to the opposite face of the peelable layer in the first reinforcement part, and the back surface of the support member is bonded to the opposite face of the peelable layer in the second reinforcement part. One end of the support member is attached to the opposite face of the peelable layer in the third reinforcement part, and the other end of the support member is connected to the fixing member.

Preferably, the total length of the reinforcement layer of the anastomotic stoma reinforcement is respectively greater than the total length of the adhesive layer and the peelable layer, 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 positioned on the reinforcement layer to secure the stoma reinforcement to the support. The fixing member is located between the length edge of the reinforcement layer and the length edge of the peelable layer, so that the fixing member can fix the reinforcement member by clamping the end of the reinforcement layer to facilitate the removal of the peelable layer from the reinforcement member .

Preferably, the peelable layer includes a silicone oil layer and a base layer, the base layer is made of paper or PET film, and the peelable layer is used to maintain the viscosity of the adhesive layer and form a layer between the adhesive layer and the external environment. Isolation to ensure that the adhesive layer does not stick in place before use.

The function of the reinforcement layer is to be used for the target tissue, to assist the stapler to get reinforced sutures, to play a role of support and reinforcement, and to reduce or avoid the damage of the staples to the target tissue.

As a preference, the material of the reinforcement layer can also be selected from the sheet-like extracellular matrix material of animal origin containing non-cross-linked collagen fibers, mucopolysaccharides, growth factors and glycoproteins; the material of the reinforcement layer has no immunogen It is non-toxic, degradable in vivo, and has a three-dimensional mesh porous structure, which can strengthen the anastomotic stoma.

The material of the reinforcement layer can be any suitable biocompatible material, reconstituted or naturally derived collagen support material, and the like. Collagen support materials, especially extracellular matrix materials, have attracted our attention because of their advantages in hemostasis and wound healing. Extracellular matrix materials can come from submucosa, capsule, dura mater, pericardium, peritoneum, dermal collagen, myofascial membrane, etc. In the present invention, submucosa, especially that of warm-blooded animals, is preferred as the material for the reinforcement layer. Types with and without cross-linking agents can be selected, and the mammalian submucosa extracellular matrix material that maintains the natural three-dimensional structure is preferred. Considering the abundant and easy-to-obtain material sources, it is more suitable to use the extracellular matrix materials of breeding animals such as pigs, cattle, and sheep as the source of meat or other products. Porcine small intestinal submucosa is the preferred material of the present invention, and its source and processing method can refer to Chinese patent ZL201310203603.7.

Extracellular matrix materials can selectively retain growth factors or other biologically active components of the original tissue. For example, the extracellular matrix material may 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 materials used in the present invention may also contain biomass such as heparin, heparan sulfate, hyaluronic acid, and fibronectin. Therefore, in general, extracellular matrix materials may contain a bioactive component that can directly or indirectly induce cellular responses, such as changes in cell morphology, division, growth, protein or gene expression. In addition, non-native biologically active substances obtained by recombinant technology or other methods can also be added to the extracellular matrix material as a supplement or substitute for the native biologically active components.

Other non-bioabsorbable or biodegradable synthetic polymer materials such as polytetrafluoroethylene materials (PTFE, such as GORE-TEX materials), nylon, PP, polyurethane, silicone, PGA, PLA or polycaprolactone, also Materials that can be used in the present invention as the reinforcement layer.

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

The adhesive layer can be used to form a connection between the working surface of the kiss/closer and the reinforcement layer, so that the reinforcement layer can be transported to the target tissue, and between the working surface of the kiss/closer and the target tissue, anastomosis is achieved For the reinforcement of the staple line, preferably, the material of the adhesive layer includes protein glue.

Preferably, the support member can provide a support surface of a plane, a curved surface, a bent surface or a stepped surface. More preferably, the material of the support is ceramic, metal, rubber or plastic. Usually, when the supporting member is a flat hard or rigid material, it is impossible to guarantee the stable installation of the reinforcement layer for the non-planar nail anvil surface and the staple cartridge surface in the prior art, especially for curved and bent surface shapes. For the working surface and the stepped working surface, the adhesive layer on the reinforcement layer cannot fully contact with the working surface, so effective bonding cannot be achieved, which may cause the reinforcement layer to fall off. The reinforcement layer can be supported by supports matching the non-planar working surface. The supporting surface of the support can be a curved surface, a bent surface or a stepped surface matching the working surface of the kiss/closer. In addition, flexible or elastic materials may be used to provide variable support surfaces. These materials have a planar structure when there is no external force; when the reinforcement is installed, these materials are deformed by being squeezed, so they can also provide curved, bent or stepped surfaces. Since the fixture is usually flexible, the reinforcement layer can still be fixed on the support by using the fixture. During the bonding process, since the surface of the support has the same shape as the working surface, and the reinforcement layer and the adhesive layer themselves are The flexibility can be deformed, so when the anvil and the staple cartridge are clamped, the adhesive layer on the support will closely fit and fully bond with the anvil and the staple cartridge, thus ensuring the bonding strength.

When making the reinforcement assembly of the present invention, the adhesive layer can be coated on the peelable layer first, and after drying, the anastomotic reinforcement and the support are attached so that the adhesive layer is transferred to the reinforcement layer; The adhesive layer is made on the fixed layer; the adhesive layer can be continuously arranged on the surface of the reinforcement layer, or discontinuously arranged on the surface of the reinforcement layer.

After adopting the above structure, an anastomotic stoma reinforcement assembly of the present invention has the following advantages compared with the prior art: the anastomotic stoma reinforcement is accurately fixed on the staple bin and/or the anvil of the stapler by pasting , and with the anastomosis/closer front end on the body surface or into the body to complete the anastomosis operation. The fixation between the anastomotic reinforcement and the anastomosis/closer is completed in free space, without being limited by the operating space. Moreover, the assembled anastomotic stoma reinforcement and the anastomosis/closer move together so that no relative displacement occurs.

Another object of the present invention is to provide a method for using the anastomotic stoma reinforcement assembly, which can bond the reinforcement layer to the anastomotic/closed working surface at one time, simplifying the operation process and facilitating operation.

The technical solution adopted by the present invention is to provide a method for using the anastomotic stoma reinforcement assembly, which uses the method to bond the reinforcement layer on the kiss/closer: open the anvil and the staple cartridge on the kiss/closer, remove the The peelable layer of the anastomotic stoma reinforcement assembly corresponding to the shape of the staple/closer staple bin and anvil block is placed between the openings of the anvil and the staple bin and aligned with the working surfaces of the anvil and the staple bin, After alignment, close the anvil and the staple bin, clamp them, make the adhesive layer stick to the anvil and the staple bin, take off the fixing part, open the nail anvil and the nail bin again, and take off the supporting part.

Preferably, the bonding of the adhesive layer on the anvil of the kiss/closer and the staple cartridge is a removable connection, and the thickness of the support member can be set according to the allowable thickness between the staple cartridge and the staple cartridge, The thickness of the preferred support is 50-1000 microns, and its viscosity can be controlled by controlling the thickness of the coating in use, so that the bonding of the adhesive layer on the kiss/closer is a removable connection, and the stitching of the reinforcement layer remains The force is above 5N.

The present invention provides a reinforcement assembly. The integrally designed reinforcement layer is fixed on the working surface of the staple cartridge and the anvil at one time through the adhesive layer, so as to strengthen the fragile tissue during the operation and avoid unwanted damage. Breakage and leaks. And further, by setting 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 surfaces of the staple cartridge and the staple anvil.

Description of drawings

Fig. 1 is a schematic diagram of an exploded structure of an anastomotic stoma reinforcement assembly of the present invention;

Fig. 2 is a kind of anastomotic stoma reinforcement assembly of the present invention and its partially enlarged structural schematic diagram;

Fig. 3 is a schematic diagram of various embodiments of the reinforcement of the present invention;

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

Fig. 5 is a schematic diagram of the installation of the anastomotic stoma reinforcement assembly of the present invention;

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

detailed description

The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments.

As shown in Fig. 1 and Fig. 2, the present invention provides an anastomotic stoma reinforcement assembly 1, which includes an anastomotic stoma reinforcement 2, a support 3 and a fixing part 4, the anastomotic stoma reinforcement 2 is matched with the support 3, and the fixing part 4. Fix the anastomotic stoma reinforcement 2 on the support 3. The anastomotic stoma reinforcement 2 includes a first reinforcement part 21, a second reinforcement part 22 and a third reinforcement part 23. The two ends of the third reinforcement part 23 are respectively connected to the first One end of the reinforcement part 21 and one end of the second reinforcement part 22 are connected, and the anastomotic stoma reinforcement 1 includes a peelable layer 2c, an adhesive layer 2b and a reinforcement layer 2a.

One side of the support member 3 is bonded to the opposite face of the peelable layer 2c in the first reinforcing part 21, and the other face of the support member 3 is bonded to the opposite face of the peelable layer 2c in the second reinforcing part 22 to support One end of the part 3 is attached to the opposite side of the peelable layer 2c in the third reinforcement part 23, and the fixing part 4 is set on the other end of the support part 3, that is to say, the support part 3 and the reinforcement layer 2a of the anastomotic reinforcement part 2 fit.

The total length of the reinforcement layer 2a of the anastomotic stoma reinforcement 2 is respectively greater than the total length of the adhesive layer 2b and the peelable layer 2c, 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 reinforcement layer 2a Between the length edge of the peelable layer 2c and the length edge of the peelable layer 2c, that is to say, the fixing member 4 covers the adhesive layer 2b to fix it on 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 conducive to the removal of the peelable layer 2c.

When the anastomotic stoma reinforcement assembly 1 is installed on the support 3, the first reinforcement part 21 and the second reinforcement part 22 of the reinforcement layer 2a are deformed, and when the third reinforcement part 23 and the first reinforcement part 21 and the second reinforcement When the widths of the two parts 22 are the same, the third reinforcing part 23 will be twisted and wrinkled due to the second bending after being folded in half, which will cause the first reinforcing part 21 and/or the second reinforcing part 22 (especially in The third reinforcement part 23) is not tightly combined with the working surface between the nail anvil 51 and the nail bin 52.

The cutout in the third reinforcement part 23 can solve the above-mentioned problem. As shown in Figure 3, the minimum width of the first reinforcement part 21 and the second reinforcement part 22 are all greater than the minimum width of the third reinforcement part 23, and the slit is provided as long as the minimum width of the third reinforcement part 23 is smaller than the first reinforcement part 23. The minimum width of the portion 21 and the second reinforcing portion 22 can relieve stress and reduce or eliminate twisting and wrinkling. One or more cutouts can be provided inside or on the side of the third reinforcement part 23, such as one of rectangle, triangle, arc, trapezoid, or a combination of various shapes, and even one or two cutouts can be used. gap. The cutouts can be provided on both sides of the third reinforcing part 23 , or only on one side, or a combination of internal cutouts and side cutouts can also be used.

The surface of the support member 3 can be flat, and can also be processed into a curved surface, a bent surface or a stepped surface according to the shapes of the anvil 51 and the staple cartridge 52, as shown in Figure 4, wherein the middle edge of the stepped surface can be a chamfered edge; Moreover, the number of steps can be selected according to the actual situation, and the support member 3 can also be any one of the examples shown in FIG. 4 . The material of the support member 3 can be polymer material, plastic, ceramic, metal or a combination thereof. The thickness of the support member 3 can be set according to the allowable thickness between the nail anvil 51 and the staple bin 52, the thickness of the support member 3 used in the present invention is preferably 50-1000 microns, more preferably 100-600 microns, most preferably 100 microns. - 350 microns, the support 3 may also consist of a flexible or elastic material, such as rubber or plastic. The elastic material is a planar structure when there is no external force; when the support member 3 is bonded to the anastomotic reinforcement 2, it is deformed due to the extrusion of the anvil 51 and the staple cartridge 52, thus providing a curved surface, a bent surface or a stepped surface. The combination of the support member 3 made of elastic material and the anastomotic stoma reinforcement 2 with cuts can help the adhesive layer 2 b of the anastomotic stoma reinforcement 2 fully adhere to the working surfaces of the anvil 51 and the staple cartridge 52 .

FIG. 5 is a schematic diagram of using the anastomotic stoma reinforcement assembly 1 to install the reinforcement layer 2a. It can be seen from FIG. 5 that the kissing/closing structure of the kissing/closer 5 is a jaw structure, including a nail anvil 51 and a nail bin 52 . When the anastomotic stoma reinforcement assembly 1 is installed, the anvil 51 and the staple bin 52 of the kiss/closer 5 are opened; the peelable layer 2c is removed from the anastomotic stoma reinforcement assembly 1, and put into the anvil 51 and the nail bin 52 between the working faces. Align the adhesive layer 2b with the working surfaces of the anvil 51 and the staple cartridge 52 to ensure that the adhesive layer 2b can be accurately bonded to the working surfaces of the anvil 51 and the staple cartridge 52 . After alignment, close the nail anvil 51 and the nail bin 52 and clamp them, so that the adhesive layer 2b contacts the working surfaces of the nail anvil 51 and the nail bin 52, and sticks to each other, and removes the fixing material for fixing the reinforcement layer 2a. Part 4, open the nail anvil 51 and the staple bin 52 again, and take off the supporting part 3. At this point, the reinforcement layer 2a has been bonded to the working surfaces of the anvil 51 and the staple cartridge 52 of the kiss/closer 5 and separated from the support member 3, after which the kiss/closer 5 can further implement the kiss/close operation.

The medical device provided by the present invention can be used to facilitate various surgical operations, including but not limited to various lung resection operations, treatment of soft tissue injuries and defects, and other various surgical operations. The medical device provided by the present invention can be used for human beings, and can also be used for animals. The medical 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 surgical reinforcement devices suitable for the characteristics.

The present invention is introduced with the application of the kiss/closer, but the application of the present invention is not limited to the field of surgical kiss/closer, it can also be used in other repair fields, and the size, size, and amount of adhesive can also be adjusted according to the application .

The medical device of the present invention can be provided in the form of aseptic packaging suitable for medical device products, and the sterilization can be achieved by irradiation, ethylene oxide gas or other sterilization techniques, and the material and performance of the packaging should be selected accordingly.

The preferred embodiments of the present invention have been described above, but should not be construed as limiting the claims. The present invention is not limited to the above embodiments, and its specific structure is allowed to change, and all the various changes made within the protection scope of the independent claims of the present invention are within the protection scope of the present invention.

Claims (7)

1. a kind of previous anastomotic reinforces sub-assembly, it is characterised in that：The previous anastomotic, which reinforces sub-assembly (1), includes previous anastomotic reinforcing member (2), support member (3) and fixture (4), the previous anastomotic reinforcing member (2) are arranged at the support member (3) extremely in a manner of bending On small part outer surface, previous anastomotic reinforcing member (2) is fixed on the support member (3) by the fixture (4)；

The previous anastomotic reinforcing member (2) includes the first reinforcing portion (21), the second reinforcing portion (22) and the 3rd reinforcing portion (23), described One end with the first reinforcing portion (21), one end of the second reinforcing portion (22) are connected respectively at the both ends of 3rd reinforcing portion (23), described Previous anastomotic reinforcing member (2) includes strippable coating (2c), tack coat (2b) and one or more layers back-up coat (2a)；Described 3rd reinforces Portion (23) side is provided with multiple otch；The support member can provide the supporting surface of plane, curved surface, bending side or cascaded surface；

The multiple otch is arranged on two side edges of the 3rd reinforcing portion.

2. previous anastomotic according to claim 1 reinforces sub-assembly, it is characterised in that：First reinforcing portion (21) and second The minimum widith of reinforcing portion (22) is all higher than the minimum widith of the 3rd reinforcing portion (23).

3. previous anastomotic according to claim 1 reinforces sub-assembly, it is characterised in that：Being shaped as the otch is linear, square The combination of shape, triangle, arc, trapezoidal middle one or more shapes.

4. previous anastomotic according to claim 1 reinforces sub-assembly, it is characterised in that：The previous anastomotic reinforcing member (2) adds Gu the total length of layer (2a) is respectively greater than the tack coat (2b), the total length of strippable coating (2c)；The fixture (4) is at least It is positioned partially on back-up coat (2a), the previous anastomotic reinforcing member (1) is fixed on support member (3).

5. previous anastomotic according to claim 4 reinforces sub-assembly, it is characterised in that：The total length of the strippable coating (2c) More than tack coat (2b) total length.

6. the previous anastomotic according to claim 1-5 any one reinforces sub-assembly, it is characterised in that：The support member (3) Material be ceramics, metal, rubber or plastics.

7. the previous anastomotic according to claim 1-5 any one reinforces sub-assembly, it is characterised in that：The tack coat (2b) Being connected in nail anvil (51) with the bonding on nail bin (52) for removable, the thickness of the support member (3) is 50-1000 microns, The suture confining force of the back-up coat (2a) is in more than 5N.