Anastomotic stoma reinforcing and repairing assembly, anastomotic device and application

Abstract

The application discloses an anastomotic stoma reinforcing and repairing assembly, an anastomotic device and application, and relates to the technical field of medical devices. The repairing assembly comprises a repairing sheet, a suture and a buckle. One or more free ends of the suture are fixedly connected with the buckle. The buckle fixes the free ends of the suture and is fixed to a gun body of an anastomotic device at the same time. After the anastomotic device clamps the tissue or after the anastomotic device completes cutting and anastomosis, the buckle is removed, the suture is pulled out by pulling the buckle, and the repairing sheet is separated from the anastomotic device. The anastomotic device comprises the anastomotic stoma reinforcing and repairing assembly and the anastomotic device. In the application, the anastomotic device is applied to the tissue and performs cutting, disconnection and anastomosis actions on the tissue. The anastomotic stoma reinforcing and repairing assembly is used for reinforcing the tissue. The repairing assembly in the application has the effect of reinforcing the tissue, is convenient to assemble and disassemble, and has no risk of falling off in the use process.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an anastomotic stoma reinforcing and repairing assembly, an anastomotic device and application. BACKGROUND

[0002] An anastomat is a medical device used to replace manual suturing in medicine. By firing into the tissue and implanting interlaced titanium staples, it achieves cross-suturing, and thus realizes the organization of organ disconnection, closure and functional reconstruction. Compared with traditional manual suturing, anastomat suturing has the advantages of simple operation, shortening of operation time, reduction of the probability of postoperative complications, and improvement of operation efficiency. Moreover, it can complete the anastomosis of difficult parts that traditional manual suturing cannot handle. Therefore, anastomat is widely used in thoracic surgery, gastrointestinal surgery, hepatobiliary surgery, urology surgery and the like.

[0003] Although the existing anastomat has been widely used in clinical surgery, the existing repair patch assembly is a sleeve shape with both sides fixed. The repair patch is sleeved on the anastomat cartridge assembly, and the repair patch is expanded and assembled on the anastomat cartridge assembly by the elasticity of the sleeve. The assembly process is difficult, and the two side sutures are in a non-fixed state, which is easy to interfere with the operation. The existing reinforcing repair patch and anastomat cartridge and anvil assembly are relatively complex, and the anastomotic stoma cannot be tightly closed, which results in intraoperative or postoperative bleeding, air leakage or liquid leakage. SUMMARY

[0004] In view of the problems existing in the prior art, the present application provides an anastomotic stoma reinforcing and repairing assembly, an anastomotic device and application.

[0005] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0006] An anastomotic stoma reinforcing and repairing assembly, characterized in that it comprises a repair patch, a suture and a buckle. One or more free ends of the suture are fixedly connected with the buckle. The buckle fixes the free end of the suture and is fixed to the body of the anastomat at the same time. After the anastomat clamps the tissue or after the anastomat completes cutting and anastomosis, the buckle is removed, the suture is pulled out by pulling the buckle, and the repair patch is separated from the anastomat.

[0007] Based on the above technical scheme, further, one end of the repair patch is provided with a groove, the other end of the repair patch is provided with a protrusion, a plurality of holes are arranged between the groove and the protrusion, and the suture is arranged between the groove and the protrusion by crossing the holes.

[0008] Based on the above technical scheme, further, it further comprises a backing, the repair patch and the two side edges of the backing are detachably sutured by the suture; wherein the repair patch and the backing are made of degradable material; and the suture is absorbable suture or non-absorbable suture.

[0009] Further based on the technical scheme, the end cap is formed by folding the end edge of the backing or the patch towards the other end of the backing, or folding the two sides of the backing towards the suture to form the end cap connected with the backing.

[0010] Further based on the technical scheme, the guide structure is formed from the end of the patch in a direction away from the end.

[0011] Further based on the technical scheme, the buckle includes a first semicircular body, and the two free ends of the first semicircular body are respectively provided with a first extension and a second extension, and the first extension extends away from the center of the circle, and the second extension extends away from the center of the circle.

[0012] Further based on the technical scheme, the sleeve assembly is further included, and the patch is fixed to the sleeve assembly by the suture in a detachable manner; in use, the sleeve assembly is sleeved on the nail cartridge assembly of the anastomat, and when the sleeve assembly is separated from the nail cartridge assembly, the suture is tightened to make the patch closely adhere to the nail cartridge assembly.

[0013] Further based on the technical scheme, the sleeve assembly includes a nail cartridge sleeve and a nail anvil sleeve, and the patch is fixed on the nail cartridge sleeve and the nail anvil sleeve by the suture in a cross direction; the second tab is integrally formed with one end of the nail anvil sleeve, and the nail anvil sleeve is a through hole, and the second tab is arranged at one end of the nail anvil sleeve; the first tab is integrally formed with one end of the nail cartridge sleeve, and the nail cartridge sleeve is a through hole, and the first tab is arranged at one end of the nail cartridge sleeve.

[0014] The anastomosis device includes an anastomotic orifice reinforcing and patching assembly, and an anastomat, wherein the anastomat includes a nail cartridge, a nail anvil and a connecting rod, the nail cartridge is sleeved with a nail cartridge sleeve, the nail anvil is sleeved with a nail anvil sleeve, and the connecting rod is clamped with a buckle; in use, the suture is pre-tightened, the first tab is pulled to make the nail cartridge sleeve and the patch and the nail cartridge in a separated state, the second tab is pulled to make the nail anvil sleeve and the patch and the nail anvil in a separated state, and the nail anvil is in a separated state, so as to make the patch closely adhere to the acting surface of the nail cartridge and the nail anvil.

[0015] The application of the anastomosis device includes an anastomosis device, wherein the anastomat is applied to tissue and performs cutting, disconnection and anastomosis actions on the tissue; and the anastomotic orifice reinforcing and patching assembly is used to reinforce the tissue.

[0016] Compared with the prior art, the application has the following beneficial effects:

[0017] (1) The patch in the application has the effect of reinforcing tissue, good biocompatibility and complete degradation, and its thickness is thin and does not affect the use of the stapler, and does not increase too much operation in the use process, and can effectively reduce postoperative bleeding and air leakage.

[0018] (2) The patch assembly of the application is temporarily installed before the operation in cooperation with the stapler, and the sleeve assembly and the buckle are installed quickly. The patch of the application is combined with the patch, the backing and the suture, and is bound on the sleeve assembly in advance. When used, the sleeve assembly is the intermediate medium, and assists the patch to be fixed to the cartridge assembly of the stapler. After the sleeve assembly is extracted, the suture is tightened to make the patch adhere to the cartridge assembly. The suture is fixed to the connecting rod of the body of the stapler through the buckle to avoid the interference that may occur during the operation. At the same time, the buckle can be used as a handle for the suture to be separated after the operation is completed.

[0019] (3) The application adopts the suture binding mode. Compared with the existing mode of using the suture to stitch the reinforced patch and the elastic material together to make the sleeve elastic, and taking out the suture and the elastic material after the sleeve is separated from the two sides of the suture, the separation mode of the application has high safety, low risk and high effectiveness. Moreover, the application combines the patch with the suture, and is convenient to assemble, has no risk of falling off during use, and is simple and easy to operate when separated. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 It is a structure diagram of the application in which the convex part is rectangular;

[0021] Figure 2 It is a suture structure diagram of the application in which the convex part is semicircular;

[0022] Figure 3 It is another suture structure diagram of the application in which the patch, the suture and the backing are assembled;

[0023] Figure 4 It is a structure diagram of the application in which the end cap is formed by folding the two sides of the patch inward;

[0024] Figure 5 It is a structure diagram of the cartridge sleeve of the application;

[0025] Figure 6 It is a structure diagram of the anvil sleeve of the application;

[0026] Figure 7 It is a structure diagram of the buckle of the application which is double-layered;

[0027] Figure 8 It is a structure diagram of the buckle of the application which is single-layered;

[0028] Figure 9 It is a structure diagram of the anastomosis device of the application;

[0029] Figure 10 Figure 1 is a schematic view of a staple cartridge assembly of a butt joint gun body of the anastomosis device of the present application;

[0030] Figure 1 is a schematic view of a staple cartridge assembly of a butt joint gun body of the anastomosis device of the present application; Figure 2 is a schematic view of a staple cartridge assembly of a butt joint gun body of the anastomosis device of the present application; Figure 3 is a schematic view of a staple cartridge assembly of a butt joint gun body of the anastomosis device of the present application; Figure 4 is a schematic view of a staple cartridge assembly of a butt joint gun body of the anastomosis device of the present application. DETAILED DESCRIPTION

[0031] The present application will be further described and illustrated in conjunction with the drawings and specific embodiments. The technical features of each embodiment of the present application can be combined accordingly without conflict.

[0032] In order to make the above-mentioned objectives, features and advantages of the present application more apparent, the specific embodiments of the present application will be described in detail below in conjunction with the drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a variety of ways other than those described herein without departing from the spirit of the present application, and it is understood that similar modifications can be made by those skilled in the art in the light of the foregoing description. Therefore, the present application is not limited to the specific embodiments disclosed below. The technical features of each embodiment of the present application can be combined accordingly without conflict.

[0033] In the description of the present application, it should be understood that when an element is considered to be "connected" to another element, it can be directly connected to the other element or indirectly connected to the other element with an intermediate element. In contrast, when an element is considered to be "directly" connected to another element, there is no intermediate element.

[0034] Example 1

[0035] In combination Figures 1-2 As shown in the drawings, the present embodiment provides an anastomotic orifice reinforcing patch assembly, which comprises a patch 1, a suture 2 and a buckle 22, one or more free ends of the suture 2 are fixedly connected to the buckle 22, the buckle 22 fixes the free end of the suture 2 and is fixed to the butt joint gun body of the anastomosis device at the same time, after the anastomosis device clamps the tissue or after the anastomosis device completes the cutting and anastomosis, the buckle 22 is removed, the suture 2 is pulled out by pulling the buckle 22, and the patch 1 is separated from the anastomosis device. Wherein, the suture 2 is an absorbable suture 2 or a non-absorbable suture 2; when the absorbable suture 2 is selected, the material of the suture 2 is PGA; when the non-absorbable suture 2 is selected, the material of the suture 2 is PA material.

[0036] In this embodiment, the patch 1 is provided with a groove 13 at one end, a protrusion 12 at the other end, and a plurality of holes between the groove 13 and the protrusion 12, and the suture 2 is arranged between the groove 13 and the protrusion 12 by crossing the holes. Among them, the structure of the groove 13 can improve the problem that the patch needs to be cut after use on the market, and the structure of the protrusion 12 can extend the patch 1, so as to match the structure of the stapler cartridge assembly, and the cross direction can be set according to the position of the actual plurality of holes; the hole is a round hole or an oval hole, the hole position is asymmetrically arranged, and the center of the hole is 1mm-5mm away from the edge of the patch 1. Further, the patch 1 is a degradable material; preferably, the patch 1 is a pig small intestinal submucosa biological patch, and the SIS raw material can be completely degraded within 180 days, which is more environmentally friendly, and the patch 1 can be applied to different types of nail bins 15. It should be noted that the setting of the protrusion 12 can provide guidance during assembly, and the shape of the protrusion 12 can be rectangular, semicircular, etc. For example, when the shape of the protrusion 12 is rectangular, refer to Figure 1 ; when the shape of the protrusion 12 is semicircular, refer to Figure 2 . When the protrusion 12 is arranged on the patch 1, the protrusion 12 and the backing 19 are independent structure arrangements, and since the function of the protrusion 12 is to increase guidance for the entire structure during loading, it cannot be arranged on the backing 19.

[0037] In some embodiments, the anastomotic stoma reinforcing and repairing assembly further comprises a backing 19, and the patch 1 and the two side edges of the backing 19 are detachably sutured by the suture 2, such as Figure 3 , the suture 2 on the backing 19 and the patch 1 is straight line sutured on the two sides of the backing 19 and the patch 1. Among them, the backing 19 is a degradable material; preferably, the backing 19 is an SIS patch, and the material is a pig small intestinal submucosa layer after decellularization treatment. Further, in combination with Figure 3 , the structure of the middle position of the patch 11 is rectangular, and the groove 13 structure is not arranged, and the anastomosis can also be realized.

[0038] In some embodiments, an end cap 21 is arranged at the end of the backing 19; wherein the end edge of the backing 19 is folded towards the other end of the backing 19 to form the end cap 21 connected with the backing 19, or the two sides of the backing 19 are simultaneously folded towards the position close to the suture 2 to form the end cap 21 connected with the backing 19. Specifically, the end cap 21 is shaped to match the shape of the stapler cartridge assembly and the nail bin assembly, and is preferably any one of trapezoidal, semicircular and triangular shapes, which is used to determine the position during loading and prevent the patch 1 from rotating during use.

[0039] In other embodiments, in combination with Figure 4As shown in the drawings, the end cap 21 is provided at the end of the patch 1; wherein the end edge of the patch 1 is folded to form the end cap 21 connected with the patch 1, or the two sides of the patch 1 are simultaneously folded inwardly to the position close to the suture 2 to form the end cap 21 integrally connected with the patch 1, wherein the folded end cap 21 is located at the end of the patch 1, and the two sides of the patch 1 form a vertical structure. Specifically, the end cap 21 at this position is also in any one of the shapes of trapezoidal, semicircular and triangular, which is used to assist in determining the position during loading and prevent the patch 1 from rotating during use, that is, the end cap 21 can limit the axial displacement of the patch 1.

[0040] In some embodiments, a guide structure is formed from the end of the patch 1 to the direction away from the end, so that the patch 1 partially overlaps with the end cap 21, and the guide structure can be rectangular in shape. During operation, the stapler cartridge assembly and the anvil assembly pass through the patch 1 and smoothly reach the distal end of the end cap 21.

[0041] In some embodiments, the anastomotic orifice reinforcing and patching assembly further comprises a sleeve assembly, as shown in Figure 5 and Figure 6 As shown in the drawings, the patch 1 is fixed to the sleeve assembly by the suture 2 in a detachable manner; during use, the sleeve assembly is sleeved on the anvil assembly of the stapler, and when the sleeve assembly is separated from the anvil assembly, the suture 2 is tightened to make the patch 1 closely adhere to the anvil assembly. Specifically, the sleeve assembly comprises a cartridge sleeve 3 and an anvil sleeve 5, and the patch 1 is fixed on the cartridge sleeve 3 and the anvil sleeve 5 by the suture 2 in a cross direction; the anvil sleeve 5 is provided with a second tab 6, and the second tab 6 is integrally formed with one end of the anvil sleeve 5; the anvil sleeve 5 is internally provided with a through hole, and the second tab 6 is arranged at one end of the anvil sleeve 5; in this embodiment, the through hole of the cartridge sleeve 3 is larger than that of the anvil sleeve 5; the cartridge sleeve 3 is provided with a first tab 4, and the first tab 4 is integrally formed with one end of the cartridge sleeve 3; the cartridge sleeve 3 is internally provided with a through hole, and the first tab 4 is arranged at one end of the cartridge sleeve 3.

[0042] In this embodiment, as shown in Figure 7As shown, the buckle 22 is a whole semicircular structure, which is provided with an opening structure, and the opening angle is preferably 30°-180°. Specifically, the buckle 22 includes a first semicircular body 7 and a second semicircular body 8, which have the same center. One end of the first semicircular body 7 and one end of the second semicircular body 8 are integrally formed, and the other end of the first semicircular body 7 and the other end of the second semicircular body 8 are not in contact. A through hole 17 is provided between the first semicircular body 7 and the second semicircular body 8. In use, the suture 2 passes through the through hole 17, and the diameter of the first semicircular body 7 is greater than that of the second semicircular body 8. The structure of the buckle 22 can effectively fix the suture 2, and can be used as a handle when the suture 2 is pulled out, facilitating the pulling-out operation. The sleeve assembly and the buckle 22 can be made of any high-molecular absorbable or non-absorbable material, and are preferably made of PP, PE, PA, etc. One free end of the first semicircular body 7 and the second semicircular body 8 integrally formed is provided with a first extension 9 extending away from the center. Specifically, the other free end of the first semicircular body 7 is provided with a second extension 10 extending away from the center, and the other end of the second semicircular body 8 is provided with a third extension 11 extending away from the center. The second extension 10 and the third extension 11 are arranged in parallel. It should be noted that the opening angle is the angle between the first extension 9 and the second extension 10 or the third extension 11. The first extension 9, the second extension 10, and the third extension 11 are arranged to facilitate the sleeve to be arranged on the connecting rod 14 of the stapler.

[0043] In another embodiment, referring to Figure 8 As shown, the buckle 22 only includes a first semicircular body 7, and the two free ends of the first semicircular body 7 are respectively provided with a first extension 9 and a second extension 10. The first extension 9 extends away from the center, and the second extension 10 extends away from the center. The first semicircular body 7 is provided with a through hole, and the suture 2 passes through the through hole 20 in use.

[0044] The repair assembly can greatly reduce the assembly of the reinforcing patch 1, the stapler cartridge 15, and the anvil 16 during the operation by preloading the sleeve. The buckle 22 can effectively reduce the complexity of the instrument and ensure that the reinforcing patch 1 is closely attached to the stapler cartridge 15 and the anvil 16. The suture 2 is pre-bound to the patch 1, and the patch 1 is fixed to the stapler by the suture 2 before the operation. After the stapler is clamped or cut and anastomosed, the suture 2 is separated from the patch 1, and the suture 2 is withdrawn from the body. The patch 1 is preloaded on the sleeve, which can be quickly installed on the predetermined position of the stapler, and the buckle 22 fixing the suture 2 can be bridged to the connecting rod 14 of the stapler.

[0045] Example 2

[0046] Based on the anastomosis reinforcement and repair component provided in Embodiment 1, referring to... Figure 9 and Figure 10 As shown, this embodiment provides a stapler device, which includes a stapler, a staple cartridge 15, an anvil 16, and a connecting rod 14. A staple cartridge sleeve 3 is fitted onto the staple cartridge 15; an anvil sleeve 5 is fitted onto the anvil 16; and a buckle 22 is engaged on the connecting rod 14. During use, the sleeve assembly corresponds to the staple cartridge 15 and anvil 16 of the stapler. After the sleeve assembly is fitted onto the staple cartridge 15 and anvil 16 of the stapler, the buckle 22 is engaged on the connecting rod 14 of the stapler. At this time, the suture 2 is pre-tightened, and the first lever 4 is pulled to disengage the staple cartridge sleeve 3 from the repair piece 1 and the staple cartridge 15. The second lever 6 is pulled to disengage the anvil sleeve 5 from the repair piece 1 and the anvil 16, causing the repair piece 1 to adhere tightly to the working surfaces of the staple cartridge 15 and the anvil 16.

[0047] The installation process of the anastomosis device in this embodiment is as follows:

[0048] Confirm the stapler's gun packaging is intact, then open the packaging; confirm... Figure 9 The other part of the docking structure is well packaged; open the package. Assemble the docking end 18 of the docking structure with the gun body of the stapler according to the instructions. Confirm that the reinforcement patch 1 is well packaged; open the package. At this time, the reinforcement patch 1 needs to be pre-tied to the sleeve. Then, put the staple cartridge sleeve 3 and the staple anvil sleeve 5 on the corresponding sleeves. Figure 9 In the docking structure shown, the repair patch 1 is positioned with the staple cartridge 15 and anvil 16 facing inwards towards the angle in the docking structure. Straighten the suture 2 to avoid tangling, and use the clip 22 to press the free end of the suture 2 firmly onto the connecting rod 14. Repeat the operation on the other side, gripping the sleeve assembly and pulling upwards to separate the staple cartridge sleeve 3 and anvil sleeve 5, so that the reinforced repair patch 1 fits into the staple cartridge assembly of the stapler. Adjust the tension of the suture 2 to ensure the repair patch 1 fits into the staple cartridge 15 and anvil 16 of the stapler. It should be noted that the stapler is an existing structure and will not be described in detail here; only the assembly structure and operating principle of the repair component and the stapler are illustrated.

[0049] Example 3

[0050] Based on the anastomosis device including an anastomotic device and an anastomosis reinforcement and repair component in Embodiment 2, this embodiment also provides an application of the anastomosis device, wherein the anastomotic device is applied to tissue and performs cutting, severing, and anastomosis actions on the tissue; the anastomosis reinforcement and repair component is used to strengthen the tissue.

[0051] Finally, it should be noted that the above is only to illustrate the technical solutions of the present application, and is not a limitation on the scope of protection of the present application, and simple modifications or equivalent replacements of the technical solutions of the present application by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A joint reinforcement and repair component, characterized in that: Includes repair patches, sutures, and clips. One or more free ends of the suture are fixedly connected to a buckle. The buckle fixes the free ends of the suture and simultaneously fixes them to the gun body of the stapler. The buckle includes a first semicircular body and a second semicircular body. The first semicircular body and the second semicircular body are concentric. One end of the first semicircular body and one end of the second semicircular body are integrally formed. The other end of the first semicircular body and the other end of the second semicircular body are not in contact. A perforation is reserved between the first semicircular body and the second semicircular body. During use, the suture passes through the perforation. The diameter of the first semicircular body is larger than the diameter of the second semicircular body. After the stapler clamps the tissue or after the stapler has completed cutting and anastomosis, remove the clips, pull the clips to pull out the sutures, and remove the repair patch from the stapler.

2. The anastomosis reinforcement and repair component according to claim 1, characterized in that: The repair patch has a groove at one end and a protrusion at the other end. Several holes are provided between the groove and the protrusion, and the suture passes through the holes and crosses between the groove and the protrusion.

3. The anastomosis reinforcement and repair component according to claim 1, characterized in that: It also includes a backing, which is detachably sewn to the two sides of the backing with stitches; Both the repair patch and the backing are made of biodegradable materials. The sutures can be absorbable or non-absorbable.

4. The anastomosis reinforcement and repair component according to claim 3, characterized in that: The backing is provided with an end cap at the end. The end edge of the backing is folded toward the other end of the backing to form an end cap connected to the backing, or both sides of the backing are folded inward toward the seam to form an end cap connected to the backing.

5. The anastomosis reinforcement and repair component according to claim 3, characterized in that: The repair patch is provided with an end cap at one end. The edge of the end of the repair patch is folded toward the other end of the repair patch to form an end cap that is connected to the repair patch. Alternatively, both sides of the repair patch are folded inward toward the suture to form an end cap that is connected to the repair patch.

6. The anastomosis reinforcement and repair component according to claim 1, characterized in that: A guide structure extends from the end of the patch away from that end.

7. The anastomosis reinforcement and repair component according to claim 1, characterized in that: It also includes a sleeve assembly, which allows the patch to be removably attached to the sleeve assembly via sutures; In use, the sleeve assembly is fitted onto the stapler cartridge assembly. When the sleeve assembly disengages from the nail cartridge assembly, tighten the suture to ensure a tight fit between the patch and the nail cartridge assembly.

8. The anastomosis reinforcement and repair component according to claim 7, characterized in that: The sleeve assembly includes a staple cartridge sleeve and a staple anvil sleeve, with repair patches fixed to the staple cartridge sleeve and the staple anvil sleeve respectively by crisscrossing stitches; the staple anvil sleeve is provided with a second paddle, which is integrally formed with one end of the staple anvil sleeve, and the staple anvil sleeve has a through hole inside, with the second paddle located at one end of the staple anvil sleeve; the staple cartridge sleeve is provided with a first paddle, which is integrally formed with one end of the staple cartridge sleeve, and the staple cartridge sleeve has a through hole inside, with the first paddle located at one end of the staple cartridge sleeve.

9. A matching device, characterized in that: The anastomosis reinforcement and repair assembly according to any one of claims 1-8 further includes an anastomosis device, the anastomosis device comprising a staple cartridge, an anvil, and a connecting rod. A staple cartridge sleeve is fitted onto the staple cartridge; a staple anvil sleeve is fitted onto the staple anvil; a buckle is engaged on the connecting rod; During use, pre-tighten the suture, pull the first lever to disengage the staple cartridge sleeve from the repair patch and the staple cartridge, and pull the second lever to disengage the anvil sleeve from the repair patch and the anvil, so that the repair patch is in close contact with the working surfaces of the staple cartridge and the anvil.

Images