CN119488394A - A coated stent for pancreatico-enterostomy and a manufacturing method thereof - Google Patents

Abstract

The application discloses a covered stent for pancreatic anastomosis and a manufacturing method thereof. The tectorial membrane stent comprises a columnar self-expansion stent body after expansion, wherein one end of the self-expansion stent body is set to be a pancreatic end of the stent, a convex jejunum end of the stent after expansion is arranged at a position, close to the end, of the other end of the self-expansion stent body, a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expansion stent body, and an annular piece is arranged on one side, close to the pancreatic end of the stent, of the self-expansion stent body. By adopting the tectorial membrane bracket, the contact stability of the self-expanding bracket body and the inner wall of the pancreatic duct can be improved, the use stability of the tectorial membrane bracket is improved, and the risk of pancreatic fistula is reduced.

Description

Tectorial membrane bracket for pancreas-intestine anastomosis and manufacturing method thereof

Technical Field

The application relates to the technical field of medical equipment, in particular to a tectorial membrane bracket for pancreatic intestinal anastomosis and a manufacturing method thereof.

Background

Pancreatic fistulae are the most serious complication of post-pancreatectomy, and pancreatic surgeons have been striving to reduce the risk of pancreatic fistulae by technological improvement or drug treatment, but even in large pancreatic surgical centers, the incidence of pancreatic fistulae after pancreatic surgery is as high as 3-45%. Pancreatic fistulae, particularly those that occur in patients who have undergone a pancreatic jejunostomy, are the most important risk factors for poor patient prognosis. Pancreatic fistulae can cause fluid accumulation in the abdominal cavity, delayed gastric emptying, abdominal infections, bleeding, re-surgery, and even patient death. Patients undergoing pancreatectomy and pancreatic jejunostomy in large pancreatic surgical centers can still have a perioperative mortality rate of up to 3-5% due to the presence of pancreatic fistulae.

Although it has been clarified that there are a plurality of risk factors for the occurrence of pancreatic fistula, including the pancreatic softness, the smaller main pancreatic duct, the posterior pancreatic duct, etc., only the pancreatic anastomosis technique is the factor that can be controlled by the surgeon, and in order to reduce the risk of occurrence of pancreatic fistula, the surgeon is also trying to try various pancreatic anastomosis methods, but since there is no anastomosis method so far that can prevent the occurrence of pancreatic fistula or that the risk of occurrence of pancreatic fistula is far lower than other anastomosis methods, there is no consensus on how to perform pancreatic anastomosis. In order to address the problems of pancreatic fistulae, international pancreatic surgery groups have issued international consensus on grading and treatment of pancreatic fistulae and have also attempted to reduce the risk of pancreatic fistulae by standardizing the manner of pancreatic jejunal anastomosis, but for the reasons mentioned above no consensus has been reached and only the current situation has been described.

At present, although various pancreatic anastomosis modes are different, the basic idea is based on direct anastomosis of pancreatic duct and jejunum mucosa, and pancreatic juice is directly introduced into jejunum. However, due to the brittle special nature of the pancreatic structure, the pancreatic duct is positioned in the pancreas, the diameter of the pancreatic duct is small, the wall of the pancreatic duct is thin, and the corrosiveness of pancreatic juice secreted by the pancreatic duct is difficult to ensure the complete fit between the pancreatic duct and jejunum mucosa and the subsequent good healing in a suturing mode, which may be the root cause that various anastomosis modes cannot completely avoid pancreatic fistula, and the traditional operation has the following defects:

1) The shaping bracket is mainly used clinically, the thickness variation of pancreatic duct of a patient is large, and the shaping bracket is difficult to be completely matched with the pancreatic duct, so that pancreatic juice leaks.

2) Even a perfectly matched stent may result in a stent mismatch during the post-operative procedure due to edema and regression of pancreatic and jejunal tissue.

3) The prior art needs to open holes in jejunum, suture of pancreatic duct and jejunum is performed after the stent is placed in jejunum, the suture difficulty is high, and the gap between the pancreatic duct and jejunum cannot be completely closed.

Disclosure of Invention

In order to solve the defects in the prior art, the invention aims to provide a covered stent for pancreatic anastomosis and a manufacturing method thereof, which can solve at least one technical problem.

In order to achieve the above purpose, the invention adopts a technical scheme that a covered stent for pancreatic and intestinal anastomosis is provided, and the covered stent comprises:

The self-expanding support comprises a post-expansion self-expanding support body, wherein one end of the self-expanding support body is set to be a pancreatic end of the support, a convex support jejunum end after expansion is arranged at a position, close to the end, of the other end of the self-expanding support body, and a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expanding support body;

wherein, self-expanding support body is close to support pancreas end one side is provided with the ring spare.

Optionally, the number of the annular pieces is multiple, and the annular pieces are equally spaced on the outer surface of the self-expanding bracket body, or

The annular piece is spirally wound on the self-expanding bracket body.

Optionally, the annular piece is sleeved on the outer surface of the self-expanding bracket body, or

The ring is woven to the self-expanding stent body.

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

Optionally, the tail end of the pancreatic end of the bracket is also provided with barbs.

In order to achieve the aim, the invention adopts the technical proposal that a manufacturing method of a tectorial membrane bracket for pancreas-intestine anastomosis is provided,

Braiding a plurality of wires to form a columnar self-expanding bracket body after expansion;

Heating and shaping one end of the self-expanding stent body to form a stent jejunum end which can be expanded and then outwards protruded, and forming a stent pancreas end at the other end;

a plurality of annular pieces are arranged on one side, close to the pancreatic end of the self-expanding stent body, of the stent;

And a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the body.

Optionally, the annular piece is sleeved on the outer surface of the self-expanding bracket body, or

The ring is woven to the self-expanding stent body.

Optionally, the disposing a membranous material layer for preventing pancreatic juice from leaking on the surface of the self-expanding stent body includes:

Immersing the self-expanding stent body in membranous material liquid, and solidifying the membranous material liquid on the surface of the self-expanding stent body to form a membranous material layer coating the surface of the self-expanding stent body.

The application provides a tectorial membrane bracket for pancreatic intestinal anastomosis and a manufacturing method thereof. According to the covered stent for pancreatic intestinal anastomosis, provided by the application, the contact stability of the self-expanding stent body and the inner wall of a pancreatic duct can be improved by arranging the annular piece, the use stability of the covered stent is improved, and the risk of pancreatic fistula is reduced.

Drawings

FIG. 1 is a schematic view of an embodiment of a stent graft for pancreatic anastomosis according to the present application;

FIG. 2 is a schematic view of the placement of the stent graft of FIG. 1 in a pancreatic anastomosis procedure;

Fig. 3 is a schematic flow chart of an embodiment of a method for manufacturing a covered stent for pancreatic anastomosis.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present application and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, directly connected, indirectly connected through an intervening medium, or in communication between two elements or in an interaction relationship between two elements, unless otherwise explicitly specified. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present application, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Referring to fig. 1-2, fig. 1 is a schematic structural view of an embodiment of a stent graft for pancreatic anastomosis according to the present application, and fig. 2 is a schematic structural view of the stent graft shown in fig. 1 in a position during a pancreatic anastomosis operation.

In the embodiment, a covered stent for pancreatic anastomosis is disclosed, wherein the covered stent 10 comprises a self-expanding stent body 1 which is columnar after expansion, one end of the self-expanding stent body 1 is set to be a stent pancreatic end 11, the other end of the self-expanding stent body is close to the end, a stent jejunum end 12 which is convex after expansion is arranged, a membranous material layer (not shown in the figure) for preventing pancreatic juice leakage is arranged on the surface of the self-expanding stent body 1, and an annular piece 111 is arranged on one side of the self-expanding stent body 1 close to the stent pancreatic end 11.

In this embodiment, by providing the ring member 111, the contact stability between the self-expanding stent body 1 and the inner wall of the pancreatic duct can be improved, the use stability of the covered stent 10 can be improved, and the risk of pancreatic fistula can be reduced.

The procedure was as follows:

Firstly, a stent conveyer (the existing medical stent conveyer) is used for conveying a self-expanding stent body 1 to an anastomosis position of jejunum and pancreas for segmented release, specifically, firstly, a stent pancreas end 11 of a stent is inserted into a pancreas tube (a) until a mark position (the mark position is close to the joint of the stent pancreas end 11 and the stent jejunum end 12, namely, the size gradual change position of the stent pancreas end 11 and the stent jejunum end 12 in fig. 1) is formed, the stent pancreas end 11 is completely released in a pancreas tube section (the friction force generated by the stent jejunum end 12 and the pancreas tube after expansion makes the stent pancreas end 11 and the pancreas tube relatively fixed), then the pancreas whole layer and the intestinal tract are sutured, the stent is continuously released until the stent is completely released, and after the release, the stent jejunum end 12 is expanded to be attached to the pancreas (pancreas stump S), the whole stent has the following advantages:

1) The support has strong adaptability and can meet the requirements of pancreatic duct anastomosis sizes of different specifications;

2) The stent is completely attached to the pancreatic duct through self-expansion and film coating (film coating material layer), so that pancreatic juice between the stent and the pancreatic duct is prevented from leaking;

3) The self-expansion and pancreas tube generate friction force, so that the bracket is not easy to slide;

4) The gap between the bracket and the jejunum is closed by self-expansion of the jejunum end 12 of the bracket, so that leakage of intestinal juice is avoided;

5) The intestinal wall is attached to the section of the pancreas stump through the expanded jejunum end 12 of the stent, so that the pancreas tube and jejunum are prevented from being sutured;

6) The design simplifies the operation steps and reduces the risk of pancreatic fistula.

In this embodiment, the number of the ring members 111 is optionally plural, and the plural ring members 111 are equally spaced on the outer surface of the self-expanding stent body 1. In some other embodiments, the number of the ring-shaped members 111 is one, and the ring-shaped members 111 may be spirally wound around the self-expanding stent body 1.

Wherein the ring 111 is optionally sleeved on the outer surface of the self-expanding stent body 1, and can be fixed on the outer surface of the self-expanding stent body 1 by welding, or in other embodiments, the ring 111 can be woven on the self-expanding stent body 1.

In this embodiment, by providing the ring member 111, a plurality of annular protrusions can be formed, so that the contact stability with the inner wall of the pancreatic duct can be improved.

Further, the membranous material layer is covered on the annular member, and the membranous material layer does not extend to the tail end of the pancreatic end 11 of the bracket. Referring to fig. 1-2, a membranous material layer is disposed in the middle region of the self-expanding stent body 1, and extends from the stent jejunal end 12 to the stent pancreatic end 11, wherein the membranous material layer is formed by immersing the self-expanding stent body 1 in the membranous material liquid and solidifying the membranous material liquid on the surface of the self-expanding stent body 1 to form the membranous material layer covering the surface of the self-expanding stent body 1. Wherein, the membranous material layer can cover the annular surface of the expansion bracket body 1, thereby avoiding pancreatic juice leakage.

Wherein, the end of the support pancreas end 11 is a region covered with a membranous material layer, and barbs can be arranged by arranging the barbs, so that the barbs can be pricked into the pancreas tube, and the support pancreas end 11 and the pancreas tube can be further fixed in position.

Furthermore, based on the same inventive concept, the application also provides a manufacturing method of the covered stent for pancreatic anastomosis.

Referring to fig. 3, fig. 3 is a schematic flow chart of an embodiment of a method for manufacturing a covered stent for pancreatic anastomosis according to the present application.

The manufacturing method of the covered stent for pancreatic intestinal anastomosis specifically comprises the following steps:

s11, braiding a plurality of wires to form a columnar self-expanding bracket body after expansion.

And S12, heating and shaping one end of the self-expanding stent body to form a stent jejunum end which can be expanded and then outwards protruded, and forming a stent pancreas end at the other end.

And S13, arranging an annular piece on one side, close to the pancreatic end of the stent, of the self-expanding stent body.

The number of the annular pieces can be multiple, and the annular pieces can be arranged on the self-expanding bracket body at equal intervals. Or the number of the annular pieces can be 1, and the annular pieces can be spirally wound on the self-expanding bracket body.

Wherein, the ring-shaped piece can be sleeved on the outer surface of the self-expanding bracket body or woven on the self-expanding bracket body,

S14, a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expanding stent body.

In the step, the self-expanding stent body is sleeved on a mandrel matched with the self-expanding stent body in shape, and then the mandrel drives the self-expanding stent body to synchronously move, so that the self-expanding stent body is immersed in membranous material liquid, wherein partial areas of the pancreatic ends of the self-expanding stent body are not immersed in membranous material liquid, after full contact, the self-expanding stent body is taken out, and membranous material liquid on the surface of the self-expanding stent body is solidified to form a membranous material layer coating the surface of the self-expanding stent body.

In summary, the application provides a covered stent for pancreatic intestinal anastomosis and a manufacturing method thereof. According to the covered stent for pancreatic intestinal anastomosis, provided by the application, the contact stability of the self-expanding stent body and the inner wall of a pancreatic duct can be improved by arranging the annular piece, the use stability of the covered stent is improved, and the risk of pancreatic fistula is reduced.

The above-described embodiments are merely illustrative of the present invention and are not intended to be all embodiments. The present invention may be embodied in other specific forms or with other specific forms without departing from its spirit or essential characteristics. The described embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. The scope of the invention should be indicated by the appended claims, and any changes that are equivalent to the intent and scope of the claims are intended to be encompassed within the scope of the invention.

Claims (8)

1. A covered stent for pancreatic anastomosis, the covered stent comprising:

The self-expanding support comprises a post-expansion self-expanding support body, wherein one end of the self-expanding support body is set to be a pancreatic end of the support, a convex support jejunum end after expansion is arranged at a position, close to the end, of the other end of the self-expanding support body, and a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expanding support body;

wherein, self-expanding support body is close to support pancreas end one side is provided with the ring spare.

2. The stent graft as recited in claim 1, wherein,

The number of the annular pieces is a plurality, and the annular pieces are equally spaced on the outer surface of the self-expanding bracket body, or

The annular piece is spirally wound on the self-expanding bracket body.

3. The stent graft as recited in claim 2, wherein,

The annular piece is sleeved on the outer surface of the self-expanding bracket body, or

The ring is woven to the self-expanding stent body.

4. The stent graft as recited in claim 3, wherein,

The membranous material layer covers the annular piece, and does not extend to the tail end of the pancreatic end of the bracket.

5. The stent graft as recited in any one of claims 1-4, wherein,

The tail end of the pancreatic end of the bracket is also provided with barbs.

6. A manufacturing method of a covered stent for pancreatic anastomosis is characterized in that,

Braiding a plurality of wires to form a columnar self-expanding bracket body after expansion;

Heating and shaping one end of the self-expanding stent body to form a stent jejunum end which can be expanded and then outwards protruded, and forming a stent pancreas end at the other end;

a plurality of annular pieces are arranged on one side, close to the pancreatic end of the self-expanding stent body, of the stent;

and a membranous material layer for preventing pancreatic juice from leaking is arranged on the surface of the self-expanding stent body.

7. The method of manufacturing as claimed in claim 6, wherein,

The annular piece is sleeved on the outer surface of the self-expanding bracket body, or

The ring is woven to the self-expanding stent body.

8. The method of manufacturing as claimed in claim 2, wherein,

The self-expanding stent body surface is provided with a membranous material layer for preventing pancreatic juice leakage, and the self-expanding stent comprises:

Immersing the self-expanding stent body in membranous material liquid, and solidifying the membranous material liquid on the surface of the self-expanding stent body to form a membranous material layer coating the surface of the self-expanding stent body.