A degradable biliary anastomosis device and its use method

Abstract

The present invention discloses a degradable biliary stapler and a method for using the biliary stapler. The biliary stapler comprises a stapler body, an inner layer support and an outer layer support sleeved on the inner layer support, the inner layer support is provided with a channel running through it, the outer layer support comprises a first main body, a connecting part and a second main body, the connecting part is sleeved on the inner layer support, the first main body is connected to the second main body via the connecting part, wherein along the radial direction of the channel, part of the first main body protrudes from the connecting part, and part of the second main body protrudes from the connecting part, so that the biliary stapler can adapt to the common bile duct of a recipient and the common bile duct of a donor of different sizes, thereby reducing the risk of exudate leakage after biliary anastomosis.

Description

Technical Field

[0001] The present invention relates to the technical field of anastomosis instruments, and in particular to a degradable biliary anastomosis instrument and a method for using the same. Background Art

[0002] After liver transplantation, the recipient's common bile duct and the donor's common bile duct are generally anastomosed using a biliary stapler. However, the sizes of the recipient's common bile duct and the donor's common bile duct are usually different. Existing biliary staplers cannot adapt to common bile ducts of different sizes, and the risk of exudate leakage after biliary anastomosis is high. Summary of the invention

[0003] The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, the present invention provides a degradable biliary anastomosis device, which can reduce the risk of leakage after biliary anastomosis.

[0004] The invention also provides a method for using the biliary anastomosis device.

[0005] According to an embodiment of the first aspect of the present invention, a biliary stapler comprises a stapler body, wherein the stapler body comprises an inner layer support and an outer layer support sleeved on the inner layer support, wherein the inner layer support is provided with a channel running through the inner layer support, wherein the channel is used for bile circulation, and wherein the outer layer support comprises a first main body portion, a connecting portion and a second main body portion, wherein the connecting portion is sleeved on the inner layer support, and the first main body portion is connected to the second main body portion via the connecting portion; wherein, along the radial direction of the channel, a portion of the first main body portion protrudes from the connecting portion, and a portion of the second main body portion protrudes from the connecting portion.

[0006] The biliary anastomosis device according to the first embodiment of the present invention has at least the following beneficial effects:

[0007] When performing a liver transplant, the first main body is inserted into the common bile duct of the recipient so that the end of the common bile duct of the recipient is sleeved on the connecting part. After that, the second main body is inserted into the common bile duct of the donor so that the end of the common bile duct of the donor is sleeved on the connecting part. The ends of the common bile duct of the recipient and the end of the common bile duct of the donor are moved by external force so that the ends of the common bile duct of the recipient overlap with the ends of the common bile duct of the donor. Then, the ends of the common bile duct of the recipient and the end of the common bile duct of the donor are anastomosed by staplers, and the liver transplantation operation can be completed. Since the first main body partially protrudes from the connecting part, the inner wall of the common bile duct of the recipient can be tightly attached to the outer peripheral edge of the first main body, which can prevent bile from leaking from the connection between the first main body and the common bile duct of the recipient. At the same time, the second main body partially protrudes from the connecting part, so that the inner wall of the common bile duct of the donor can be tightly attached to the outer peripheral edge of the second main body, which can prevent bile from leaking from the connection between the second main body and the common bile duct of the donor. The stapler body can be suitable for common bile ducts of different sizes, which can improve the success rate of the operation.

[0008] According to some embodiments of the present invention, the width of the first main body portion gradually increases along a direction approaching the second main body portion.

[0009] According to some embodiments of the present invention, the width of the second main body portion gradually increases along a direction approaching the first main body portion.

[0010] According to some embodiments of the present invention, a first surface is provided on a side of the first main body away from the second main body, and a second surface is provided on a side of the second main body away from the first main body, and the first surface and / or the second surface are spherical structures.

[0011] According to some embodiments of the present invention, along the circumference of the channel, the minimum distance between the first surface and the inner wall of the channel is equal, and / or the minimum distance between the second surface and the inner wall of the channel is equal.

[0012] According to some embodiments of the present invention, the inner layer support is made of a degradable material.

[0013] According to some embodiments of the present invention, a gap is provided between the inner layer support and the connecting portion, and the gap is extended along the circumference of the channel.

[0014] A method for using a biliary stapler according to a second aspect of the present invention comprises the following steps:

[0015] Step 1: Obtain the stapler body described in the first aspect of the embodiment of the present invention;

[0016] Step 2: inserting the first main body into the common bile duct of the recipient, fixing the common bile duct of the recipient to the connecting part through the first rope body, inserting the second main body into the common bile duct of the donor, fixing the common bile duct of the donor to the connecting part through the second rope body;

[0017] Step 3: sliding the end of the recipient's common bile duct and the end of the donor's common bile duct by external force, so that the end of the recipient's common bile duct is closely attached to the end of the donor's common bile duct;

[0018] Step 4: The end of the recipient's common bile duct and the end of the donor's common bile duct are anastomosed by staples.

[0019] The method for using the biliary stapler according to the second aspect of the present invention has at least the following beneficial effects:

[0020] When performing a liver transplant, the medical staff should first manually insert the first main body into the recipient's common bile duct, and use the first rope to tie the recipient's common bile duct into a purse-like shape and temporarily fix it to the connection part to prevent the first main body from falling off, and then manually insert the second main body into the donor's common bile duct, and use the second rope to tie the donor's common bile duct into a purse-like shape and temporarily fix it to the connection part. At this time, the medical staff uses their fingers to slide the ends of the recipient's common bile duct and the donor's common bile duct on the connection part and bring them close together until the ends of the recipient's common bile duct and the end of the donor's common bile duct are in close contact. Next, the biliary stapler anastomosis operation is performed, and the staples are pre-installed on the anastomosis head of the scissor-type anastomosis instrument. The anastomosis head can store multiple staples, and the number of staples is manually replenished to a sufficient amount. The anastomosis part is pre-attached to the end of the recipient's common bile duct and the overlap position of the donor's common bile duct. The medical staff squeezes the handle of the scissor-fork type anastomosis instrument so that the anastomosis staples are pressed down and fixed on the outer support through the anastomosis head. This is the implantation process of a pair of anastomosis staples. Then the scissor-fork type anastomosis instrument is rotated around the axis of the connection part to a certain angle to implant another pair of anastomosis staples, and so on until it returns to the implantation point of the first anastomosis staples. The operation is completed after checking that there is no leakage in the common bile duct.

[0021] According to some embodiments of the present invention, in step 4, the anastomotic staple is installed on the anastomotic head of a scissors-type anastomotic instrument, the anastomotic head is attached to the end of the common bile duct of the recipient and the overlapping position of the common bile duct of the donor, and the anastomotic staple is fixed to the outer layer support by pressing the scissors-type anastomotic instrument.

[0022] According to some embodiments of the present invention, the staplers are configured in plurality, and the plurality of staplers are spaced apart along the circumference of the channel.

[0023] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above and / or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0025] Figure 1 It is a schematic diagram of the structure of the biliary stapler of an embodiment of the present invention when anastomosing the biliary tract;

[0026] Figure 2 It is a schematic diagram of the structure of the biliary stapler after anastomosis of the biliary tract according to an embodiment of the present invention;

[0027] Figure 3 Schematic diagram of the internal structure of the biliary stapler according to an embodiment of the present invention.

[0028] Reference numerals:

[0029] Gap 101, inner layer support 110, channel 111, outer layer support 120, first body portion 121, first surface 1211, connecting portion 122, second body portion 123, second surface 1231, recipient's common bile duct 210, donor's common bile duct 220, first rope body 310, second rope body 320, staples 330, scissors-type stapling instrument 400, stapling head 410, and handle portion 420. DETAILED DESCRIPTION

[0030] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0031] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0032] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0033] In the description of the present invention, unless otherwise clearly defined, terms such as setting, installing, connecting, etc. should be understood in a broad sense, and technicians in the technical field can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific content of the technical solution.

[0034] Reference Figure 3According to the first aspect of the present invention, the biliary anastomosis device comprises a stapler body, including an inner layer support 110 and an outer layer support 120 sleeved on the inner layer support 110, the inner layer support 110 is provided with a channel 111 running through it, the outer layer support 120 comprises a first main body 121, a connecting part 122 and a second main body 123, the connecting part 122 is sleeved on the inner layer support 110, the first main body 121 is connected to the second main body 123 through the connecting part 122, wherein along the radial direction of the channel 111, part of the first main body 121 protrudes from the connecting part 122, and part of the second main body 123 protrudes from the connecting part 122, so that it can adapt to the common bile duct 210 of the recipient and the common bile duct 220 of the donor of different sizes, thereby reducing the risk of exudate leakage after biliary anastomosis.

[0035] Specifically, when performing liver transplantation, the first main body 121 is inserted into the recipient's common bile duct 210 so that the end of the recipient's common bile duct 210 is sleeved on the connecting portion 122. Then, the second main body 123 is inserted into the donor's common bile duct 220 so that the end of the donor's common bile duct 220 is sleeved on the connecting portion 122. The ends of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 are moved by external force so that the ends of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 overlap, and then the ends of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 are anastomosed by the staples 330. In a liver transplantation operation, since the first main body 121 partially protrudes from the connecting part 122, the inner wall of the recipient's common bile duct 210 can be tightly attached to the outer periphery of the first main body 121, which can prevent bile from leaking from the connection between the first main body 121 and the recipient's common bile duct 210. At the same time, the second main body 123 partially protrudes from the connecting part 122, so that the inner wall of the donor's common bile duct 220 can be tightly attached to the outer periphery of the second main body 123, which can prevent bile from leaking from the connection between the second main body 123 and the donor's common bile duct 220. The stapler body can be suitable for common bile ducts of different sizes, which can improve the success rate of the operation.

[0036] It should be noted that the outer layer stent 120 is dumbbell-shaped as a whole, and the maximum width of the first body portion 121 and the maximum width of the second body portion 123 are both larger than the outer diameter of the connecting portion 122, so it can be suitable for common bile ducts of different sizes.

[0037] It should be noted that the common bile duct 210 of the recipient and the common bile duct 220 of the donor are anastomosed to form a bile duct, and the bile in the bile duct flows through the channel 111, which will not be described in detail here.

[0038] In some embodiments of the present invention, the width of the first main body portion 121 gradually increases along the direction approaching the second main body portion 123, which can guide the first main body portion 121 to be inserted into the recipient's common bile duct 210 so that the recipient's common bile duct 210 can move to the connecting portion 122, thereby reducing the difficulty of the operation and thus improving the success rate of the operation.

[0039] Specifically, when the recipient's common bile duct 210 is sheathed, the first main body 121 is inserted into the end of the recipient's common bile duct 210. The end of the recipient's common bile duct 210 can be moved by external force to gradually expand the inner diameter of the end of the recipient's common bile duct 210. The first main body 121 can be guided to be inserted into the recipient's common bile duct 210 to facilitate the movement of the recipient's common bile duct 210 to the connecting portion 122, which can reduce the difficulty of the operation and thus improve the success rate of the operation.

[0040] It should be noted that, along the direction approaching the second main body portion 123 , the width of the first main body portion 121 may first increase and then decrease, which is not limited here.

[0041] In some embodiments of the present invention, the thickness of the second main body portion 123 gradually increases along the direction approaching the first main body portion 121, which can guide the second main body portion 123 to be inserted into the common bile duct 220 of the donor, so as to facilitate the movement of the common bile duct 220 of the donor to the connecting portion 122, thereby reducing the difficulty of the operation and thus improving the success rate of the operation.

[0042] Specifically, when the common bile duct 220 of the donor is sleeved, the second main body 123 is inserted into the end of the common bile duct 220 of the donor, and the end of the common bile duct 220 of the donor can be moved by external force so that the inner diameter of the end of the common bile duct 220 of the donor gradually expands, and the second main body 123 can be guided to be inserted into the common bile duct 220 of the donor, so as to facilitate the movement of the common bile duct 220 of the donor to the connecting part 122, which can reduce the difficulty of the operation and thus improve the success rate of the operation.

[0043] It should be noted that, along the direction approaching the first main body portion 121 , the width of the second main body portion 123 may first increase and then decrease, which is not limited here.

[0044] In some embodiments of the present invention, a first surface 1211 is provided on one side of the first main body portion 121 away from the second main body portion 123. The first surface 1211 has a spherical structure, which can increase the contact area between the first main body portion 121 and the recipient's common bile duct 210 so that the inner wall of the recipient's common bile duct 210 can be in close contact with the first surface 1211.

[0045] In addition, a second surface 1231 is provided on one side of the second main body 123 away from the first main body 121. The second surface 1231 has a spherical structure, which can increase the contact area between the second main body 123 and the common bile duct 220 of the donor, so that the inner wall of the common bile duct 220 of the donor can be in close contact with the second surface 1231.

[0046] Of course, in some specific implementations, the first surface 1211 and the second surface 1231 may also be in a conical structure, which is not limited here.

[0047] In some embodiments of the present invention, along the circumference of the channel 111, the minimum distance between the first surface and the inner wall of the channel 111 is equal, so that the force applied to the first main body 121 at each circumferential position of the channel 111 is equal, which can reduce the deformation of the first main body 121 and improve the service life of the outer layer bracket 120.

[0048] In addition, along the circumference of the channel 111, the minimum distance between the second surface and the inner wall of the channel 111 is equal, so that the force applied to the second main body 123 at each circumferential position of the channel 111 is equal, which can reduce the deformation of the second main body 123 and improve the service life of the outer layer bracket 120.

[0049] In some embodiments of the present invention, the inner stent 110 is made of a degradable material, so that the inner stent 110 can be dissolved in the alkaline environment of the bile duct and is harmless to the human body, thereby reducing the risk of exudate leakage after bile duct anastomosis.

[0050] It should be pointed out that the degradable material is an iron-based medical material. The main components of the iron-based medical material are iron, manganese, chromium and other trace elements, among which the manganese element accounts for 30-45%, the chromium element accounts for 4-8%, and the other trace elements account for 0.5-3%. The remaining components are iron elements. Other trace elements can be one or more of copper, silver, zinc, calcium, strontium, lithium, titanium, zirconium, gold, and magnesium. The iron-based medical material has sufficient material rigidity and can provide a base for the subsequent implantation and fixation of the staples 330. The degradation rate of the iron-based medical material matches the adhesion rate of the wound, which can ensure the adequacy of the bile duct anastomosis and reduce the risk of exudate leakage after the bile duct anastomosis. .

[0051] In some embodiments of the present invention, a gap 101 is provided between the inner layer support 110 and the connecting portion 122 . The gap 101 extends circumferentially along the channel 111 , which can reserve space for implantation of the staples 330 and reduce implantation resistance of the staples 330 .

[0052] Reference Figures 1 to 3 According to the second aspect of the present invention, a method for using a biliary stapler comprises the following steps:

[0053] Step 1: Obtain the stapler body;

[0054] Step 2: insert the first main body 121 into the common bile duct 210 of the recipient, fix the common bile duct 210 of the recipient to the connecting part 122 through the first rope 310, insert the second main body 123 into the common bile duct 220 of the donor, and fix the common bile duct 220 of the donor to the connecting part 122 through the second rope 320;

[0055] Step 3: Sliding the end of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 by external force, so that the end of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 are closely attached;

[0056] Step 4: The end of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 are anastomosed by staples 330 .

[0057] Specifically, the medical staff should first manually insert the first main body 121 into the recipient's common bile duct 210, and use the first rope body 310 to tie the recipient's common bile duct 210 into a purse-like shape and temporarily fix it to the connecting part 122 to prevent the first main body 121 from falling off, and then manually insert the second main body 123 into the donor's common bile duct 220, and use the second rope body 320 to tie the donor's common bile duct 220 into a purse-like shape and temporarily fix it to the connecting part 122. The operation results are as follows: Figure 1 As shown. The medical staff then slides the end of the recipient's common bile duct 210 and the end of the donor's common bile duct 220 on the connecting portion 122 and brings them close together with their fingers until the end of the recipient's common bile duct 210 is in close contact with the end of the donor's common bile duct 220. Next, the biliary stapler anastomosis operation is performed, and the staples 330 are pre-installed on the anastomosis head 410 of the scissor-type anastomosis instrument 400. The anastomosis head 410 can store multiple staples 330, and the number of staples 330 is manually replenished. The anastomosis part is pre-attached to the overlapping position of the end of the recipient's common bile duct 210 and the donor's common bile duct 220. The medical staff squeezes the handle 420 of the scissor-type anastomosis instrument 400 so that the staples 330 are pressed down and fixed on the outer layer support 120 through the anastomosis head 410. This is the implantation process of a pair of staples 330. Then the scissor-fork type anastomosis instrument 400 is rotated around the axial direction of the connection portion 122 by a certain angle to implant another pair of anastomosis staples 330, and so on until it returns to the implantation point of the initial anastomosis staples 330. The operation result is as follows: Figure 2 The operation is complete when there is no leakage in the common bile duct.

[0058] It should be noted that the scissor-fork type anastomosis instrument 400 can be rotated 30° to 90° around the axial direction of the connecting portion 122 each time, which is not limited here.

[0059] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0060] The present embodiment is described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiment, and various changes can be made within the knowledge scope of ordinary technicians in the technical field without departing from the present purpose.

Claims

1. A degradable biliary anastomosis device, characterized in that: include: The stapler body comprises an inner layer support (110) and an outer layer support (120) sleeved on the inner layer support (110), wherein the inner layer support (110) is made of a degradable material, the inner layer support (110) is provided with a channel (111) running through it, the channel (111) is used for bile circulation, the outer layer support (120) comprises a first main body portion (121), a connecting portion (122) and a second main body portion (123), the connecting portion (122) is sleeved on the inner layer support (110), and the first main body portion (121) is connected to the second main body portion (123) via the connecting portion (122); Wherein, along the radial direction of the channel (111), the first main body portion (121) partially protrudes from the connecting portion (122), and the second main body portion (123) partially protrudes from the connecting portion (122); The width of the first main body portion (121) gradually increases along a direction approaching the second main body portion (123), and the width of the second main body portion (123) gradually increases along a direction approaching the first main body portion (121). A first surface (1211) is provided on a side of the first main body portion (121) away from the second main body portion (123), and a second surface (1231) is provided on a side of the second main body portion (123) away from the first main body portion (121). The first surface (1211) and / or the second surface (1231) are spherical structures. A gap (101) is provided between the inner layer support (110) and the connecting portion (122), and the gap (101) is extended along the circumference of the channel (111) to reserve space for implanting anastomotic staples (330).

2. The degradable biliary anastomosis device according to claim 1, characterized in that: Along the circumference of the channel (111), the minimum distance between the first surface and the inner wall of the channel (111) is equal, and / or the minimum distance between the second surface and the inner wall of the channel (111) is equal.

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