Covered stent for pancreatic-intestinal anastomosis and manufacturing method thereof

Abstract

The invention discloses a covered stent for pancreatic-intestinal anastomosis and a manufacturing method of the covered stent. The covered stent comprises a self-expanding stent body which is columnar after being expanded, one end of the self-expanding stent body is a stent pancreas end, a stent jejunum end which protrudes outwards after being expanded is arranged at the position, close to the end, of the other end of the self-expanding stent body, and a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expanding stent body; the side, close to the pancreatic end of the stent, of the self-expansion stent body is provided with an annular piece. By adopting the covered stent, the contact stability of the self-expansion stent body and the inner wall of the pancreatic duct can be improved, the use stability of the covered stent is improved, and the pancreatic fistula risk is reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a coated stent for pancreatico-enteric anastomosis and a manufacturing method thereof. Background Art

[0002] Pancreatic fistula is the most serious complication after pancreatic resection. Pancreatic surgeons have been working hard to reduce the risk of pancreatic fistula through technical improvements or drug treatment, but even in large pancreatic surgical centers, the incidence of pancreatic fistula after pancreatic surgery is still as high as 3-45%. Pancreatic fistula, especially in patients who have undergone pancreaticojejunostomy, is the most important risk factor for poor prognosis. Pancreatic fistula can cause intra-abdominal fluid accumulation, delayed gastric emptying, abdominal infection, bleeding, reoperation and even death of the patient. Because of the presence of pancreatic fistula, the perioperative mortality rate of patients who have undergone pancreatic resection and pancreaticojejunostomy in large pancreatic surgical centers can still be as high as 3-5%.

[0003] Although it has been clarified that there are multiple risk factors for pancreatic fistula, including soft pancreas, small main pancreatic duct, and posterior pancreatic duct, the only factor that surgeons can control is the pancreaticojejunostomy technique. In order to reduce the risk of pancreatic fistula, surgeons are also trying various pancreaticojejunostomy methods. However, there is no anastomosis method that can prevent pancreatic fistula or the risk of pancreatic fistula is much lower than other anastomosis methods. There is still no consensus on how to perform pancreaticojejunostomy. In order to deal with the problem of pancreatic fistula, the International Pancreatic Surgery Group has published an international consensus on the classification and treatment of pancreatic fistula, and has also tried to reduce the risk of pancreatic fistula by standardizing the pancreaticojejunostomy method. However, due to the aforementioned reasons, no consensus was reached and only the current situation was described.

[0004] At present, although various pancreaticojejunostomy methods are different, the basic concept is mostly based on the direct anastomosis of the pancreatic duct and the jejunal mucosa, and the introduction of pancreatic juice directly into the jejunum. However, due to the special nature of the pancreatic structure, the pancreatic duct is located in the pancreas, the pancreatic duct is small in diameter, the pancreatic duct wall is thin, and the pancreatic juice secreted is corrosive, it is difficult to ensure that the pancreatic duct and the jejunal mucosa are completely attached and subsequently healed well by suturing. This may be the fundamental reason why various anastomosis methods cannot completely avoid pancreatic fistula. Traditional surgery has the following defects:

[0005] 1) Shaping stents are mainly used in clinical practice. However, the thickness of the pancreatic duct varies greatly among patients, and it is difficult for the shaping stent to completely match the pancreatic duct, resulting in pancreatic fluid leakage.

[0006] 2) Even a perfectly matched stent may become mismatched during the postoperative period due to edema and regression of pancreatic and jejunal tissues.

[0007] 3) The existing technology requires opening a hole in the jejunum, inserting a stent into the jejunum, and then suturing the pancreatic duct and the jejunum. The suturing is difficult and cannot guarantee complete closure of the gap between the pancreatic duct and the jejunum. Summary of the invention

[0008] In order to solve the defects of the prior art, the purpose of the present invention is to provide a covered stent for pancreatico-enteric anastomosis and a manufacturing method thereof, which can solve at least one of the above-mentioned technical problems.

[0009] In order to achieve the above object, a technical solution adopted by the present invention is: to provide a covered stent for pancreatico-enteric anastomosis, the covered stent comprising:

[0010] A columnar self-expanding stent body after expansion, one end of the self-expanding stent body is set as a stent pancreatic end, and the other end is provided with a stent jejunal end protruding outward after expansion near the end, and a membrane material layer is provided on the surface of the self-expanding stent body to prevent pancreatic fluid leakage;

[0011] Wherein, a ring-shaped member is arranged on one side of the self-expanding stent body close to the pancreatic end of the stent.

[0012] Optionally, there are multiple annular members, and the multiple annular members are arranged at equal intervals on the outer surface of the self-expanding stent body; or

[0013] The annular member is spirally wound around the self-expanding stent body.

[0014] Optionally, the annular member is sleeved on the outer surface of the self-expanding stent body; or

[0015] The annular member is woven on the self-expanding stent body.

[0016] Optionally, the membranous material layer covers the annular member, and the membranous material layer does not extend to the end of the pancreatic end of the stent.

[0017] Optionally, the end of the pancreatic end of the stent is further provided with a barb.

[0018] In order to achieve the above object, a technical solution adopted by the present invention is: to provide a method for manufacturing a covered stent for pancreatico-enteric anastomosis,

[0019] A plurality of wires are braided to form a self-expanding stent body which is columnar after expansion;

[0020] One end of the self-expanding stent body is heated and formed to form a stent jejunal end that can bulge outward after expansion, and the other end forms a stent pancreatic end;

[0021] A plurality of annular members are arranged on the self-expanding stent body close to the pancreatic end of the stent;

[0022] A membrane material layer for preventing pancreatic juice leakage is arranged on the surface of the body.

[0023] Optionally, the annular member is sleeved on the outer surface of the self-expanding stent body; or

[0024] The annular member is woven on the self-expanding stent body.

[0025] Optionally, the membrane material layer for preventing pancreatic juice leakage is provided on the surface of the self-expanding stent body, comprising:

[0026] The self-expanding stent body is immersed in a membrane material liquid, and the membrane material liquid on the surface of the self-expanding stent body is solidified to form a membrane material layer covering the surface of the self-expanding stent body.

[0027] The present application provides a covered stent for pancreaticojejunostomy and a manufacturing method thereof. The covered stent for pancreaticojejunostomy provided in the present application can improve the contact stability between the self-expanding stent body and the inner wall of the pancreatic duct by providing an annular member, improve the use stability of the covered stent, and reduce the risk of pancreatic fistula. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a structural schematic diagram of an embodiment of a covered stent for pancreatico-enteric anastomosis provided by the present application;

[0029] Figure 2 yes Figure 1 The schematic diagram of the setting position of the covered stent in the pancreatico-enterostomy surgery is shown;

[0030] Figure 3 It is a flow chart of an embodiment of a method for manufacturing a covered stent for pancreatico-enteric anastomosis provided in the present application. DETAILED DESCRIPTION

[0031] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0032] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the referred device or element 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 application.

[0033] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of this application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0034] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0035] In the present application, unless otherwise clearly specified and limited, a first feature being “above” or “below” a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being “above”, “above”, and “above” a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being “below”, “below”, and “below” a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0036] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and are not intended to be the only implementation method.

[0037] See also Figure 1-Figure 2 , Figure 1 It is a structural schematic diagram of an embodiment of a covered stent for pancreatico-enteric anastomosis provided by the present application; Figure 2 yes Figure 1 Schematic diagram of the placement of the covered stent during pancreaticojejunostomy surgery.

[0038] In the present embodiment, a coated stent for pancreatico-enteric anastomosis is disclosed, wherein the coated stent 10 comprises: a self-expanding stent body 1 which is columnar after expansion, one end of the self-expanding stent body 1 being set as a stent pancreatic end 11, and the other end near the end being provided with a stent jejunal end 12 which bulges outward after expansion, and a membrane material layer (not shown in the figure) for preventing pancreatic fluid leakage is provided on the surface of the self-expanding stent body 1; wherein, an annular member 111 is provided on the side of the self-expanding stent body 1 close to the stent pancreatic end 11.

[0039] In this embodiment, the annular member 111 is provided to improve the contact stability between the self-expanding stent body 1 and the inner wall of the pancreatic duct, improve the use stability of the stent graft 10, and reduce the risk of pancreatic fistula.

[0040] The surgical procedure is as follows:

[0041] First, a stent delivery device (existing medical stent delivery equipment) is used to deliver the self-expanding stent body 1 to the anastomosis between the jejunum and the pancreas, and then the stent is released in sections. Specifically, the stent pancreatic end 11 of the stent is first inserted into the pancreatic duct (a) until the marked position (the marked position is close to the connection between the stent pancreatic end 11 and the stent jejunal end 12, i.e., the stent is attached to the pancreatic duct). Figure 1 The pancreatic end 11 of the stent and the jejunal end 12 of the stent are gradually changed in size), the pancreatic end 11 of the stent is released in the pancreatic duct segment (the friction between the jejunal end 12 of the stent and the pancreatic duct after expansion makes it relatively fixed with the pancreatic duct), and then the whole layer of the pancreas and the intestine are sutured to fix the intestine and the pancreas, and the stent is released until it is completely released. After the release is completed, the jejunal end 12 of the stent is expanded to attach the jejunum (h) to the pancreas (pancreatic stump S). The whole stent has the following advantages:

[0042] 1) The stent has strong adaptability and can meet the requirements of pancreatic duct anastomosis sizes of different specifications;

[0043] 2) The stent is completely fitted to the pancreatic duct through self-expansion and coating (coating with a membrane material layer), thus preventing leakage of pancreatic fluid between the stent and the pancreatic duct;

[0044] 3) The self-expansion creates friction with the pancreatic duct, making the stent less likely to slide;

[0045] 4) The gap between the stent and the jejunum is closed by the self-expansion of the stent jejunal end 12 to prevent leakage of intestinal fluid;

[0046] 5) The intestinal wall is fitted to the cross section of the pancreatic stump through the expanded stent jejunal end 12 to avoid suturing the pancreatic duct and the jejunum;

[0047] 6) The above design simplifies the surgical steps and reduces the risk of pancreatic fistula.

[0048] In this embodiment, optionally, there are multiple annular members 111, and the multiple annular members 111 are evenly spaced on the outer surface of the self-expanding stent body 1. In some other embodiments, there is only one annular member 111, and the annular member 111 can be spirally wound on the self-expanding stent body 1.

[0049] Optionally, the annular member 111 is sleeved on the outer surface of the self-expanding stent body 1 and can be fixed to the outer surface of the self-expanding stent body 1 by welding; or, in another embodiment, the annular member 111 can be woven into the self-expanding stent body 1 .

[0050] Preferably, the annular member 111 can be woven onto the self-expanding stent body 1. In this embodiment, by providing the annular member 111, a plurality of annular protrusions can be formed, thereby improving the contact stability with the inner wall of the pancreatic duct.

[0051] Further, the membrane material layer is covered on the annular member, and the membrane material layer does not extend to the end of the pancreatic end 11 of the stent. Figure 1-2 The membrane material layer is arranged in the middle area of ​​the self-expanding stent body 1, and the membrane material layer extends from the stent jejunal end 12 to the stent pancreatic end 11; wherein the membrane material layer is formed by immersing the self-expanding stent body 1 in the membrane material liquid, and solidifying the membrane material liquid on the surface of the self-expanding stent body 1 to form a membrane material layer covering the surface of the self-expanding stent body 1. wherein the membrane material layer can cover the annular surface of the expandable stent body 1, thereby preventing pancreatic fluid leakage.

[0052] Barbs may be provided at the end of the pancreatic end 11 of the stent in the area covered with the membrane material layer. The barbs may be inserted into the pancreatic duct, thereby further fixing the position of the pancreatic end 11 of the stent and the pancreatic duct.

[0053] Furthermore, based on the same inventive concept, the present application also provides a method for manufacturing a coated stent for pancreatico-enteric anastomosis.

[0054] See also Figure 3 , Figure 3 It is a flow chart of an embodiment of a method for manufacturing a covered stent for pancreatico-enteric anastomosis provided in the present application.

[0055] The method for manufacturing a covered stent for pancreatico-enteric anastomosis specifically comprises the following steps:

[0056] S11: A plurality of wires are woven to form a columnar self-expanding stent body after expansion.

[0057] S12: One end of the self-expanding stent body is heated and formed to form a stent jejunal end that can bulge outward after expansion, and the other end forms a stent pancreatic end.

[0058] S13: An annular member is provided on the self-expanding stent body close to the pancreatic end of the stent.

[0059] There may be a plurality of annular members and the plurality of annular members may be arranged at equal intervals on the self-expanding stent body. Alternatively, there may be one annular member and the annular member may be spirally wound on the self-expanding stent body.

[0060] The annular member may be sleeved on the outer surface of the self-expanding stent body; or the annular member may be woven on the self-expanding stent body.

[0061] S14: a membrane material layer is provided on the surface of the self-expanding stent body to prevent pancreatic juice leakage.

[0062] In this step, the self-expanding stent body can be first sleeved onto a core shaft that matches its shape, and then the self-expanding stent body can be driven to move synchronously by the core shaft, and the self-expanding stent body can be immersed in the membrane material liquid, wherein a partial area of ​​the pancreatic end of the self-expanding stent body is configured not to be immersed in the membrane material liquid; after sufficient contact, the self-expanding stent body is taken out, and the membrane material liquid on the surface of the self-expanding stent body is solidified to form a membrane material layer covering the surface of the self-expanding stent body.

[0063] In summary, the present application provides a stent graft for pancreaticojejunostomy and a manufacturing method thereof. The stent graft for pancreaticojejunostomy provided in the present application can improve the contact stability between the self-expanding stent body and the inner wall of the pancreatic duct by providing an annular member, improve the use stability of the stent graft, and reduce the risk of pancreatic fistula.

[0064] The above-described embodiments are merely illustrative of the present invention, rather than all embodiments. The present invention may also be implemented in other specific ways or other specific forms without departing from the gist or essential features of the present invention. Therefore, the described embodiments should be considered illustrative rather than restrictive in any respect. The scope of the present invention should be described by the attached claims, and any changes equivalent to the intent and scope of the claims should also be included within the scope of the present invention.

Claims

1. A covered stent for pancreatico-enteric anastomosis, characterized in that: The stent graft comprises: A columnar self-expanding stent body after expansion, one end of the self-expanding stent body is set as a stent pancreatic end, and the other end is provided with a stent jejunal end protruding outward after expansion near the end, and a membrane material layer is provided on the surface of the self-expanding stent body to prevent pancreatic fluid leakage; Wherein, a ring-shaped member is arranged on one side of the self-expanding stent body close to the pancreatic end of the stent.

2. The stent graft according to claim 1, characterized in that: There are multiple annular members, and the multiple annular members are evenly spaced and arranged on the outer surface of the self-expanding stent body; or The annular member is spirally wound around the self-expanding stent body.

3. The stent graft according to claim 2, characterized in that: The annular member is sleeved on the outer surface of the self-expanding stent body; or The annular member is woven on the self-expanding stent body.

4. The stent graft according to claim 3, characterized in that: The membrane material layer is covered on the annular member, and the membrane material layer does not extend to the end of the pancreatic end of the stent.

5. The stent graft according to any one of claims 1 to 4, characterized in that: The end of the pancreatic end of the stent is also provided with barbs.

6. A method for manufacturing a covered stent for pancreatico-enteric anastomosis, characterized in that: A plurality of wires are braided to form a self-expanding stent body which is columnar after expansion; One end of the self-expanding stent body is heated and formed to form a stent jejunal end that can bulge outward after expansion, and the other end forms a stent pancreatic end; A plurality of annular members are arranged on the self-expanding stent body close to the pancreatic end of the stent; A membrane material layer for preventing pancreatic juice leakage is arranged on the surface of the self-expanding stent body.

7. The manufacturing method according to claim 6, characterized in that: The annular member is sleeved on the outer surface of the self-expanding stent body; or The annular member is woven on the self-expanding stent body.

8. The manufacturing method according to claim 2, characterized in that: The membrane material layer for preventing pancreatic juice leakage is provided on the surface of the self-expanding stent body, comprising: The self-expanding stent body is immersed in a membrane material liquid, and the membrane material liquid on the surface of the self-expanding stent body is solidified to form a membrane material layer covering the surface of the self-expanding stent body.

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