CN112972080B

CN112972080B - Biodegradable digestive tract leaking stoppage support and preparation method thereof

Info

Publication number: CN112972080B
Application number: CN202110211669.5A
Authority: CN
Inventors: 蒯小玲; 杨宇民
Original assignee: Nantong University; Affiliated Hospital of Nantong University
Current assignee: Nantong University; Affiliated Hospital of Nantong University
Priority date: 2021-02-25
Filing date: 2021-02-25
Publication date: 2022-11-25
Anticipated expiration: 2041-02-25
Also published as: CN112972080A

Abstract

The invention discloses a biodegradable digestive tract leaking stoppage support and a preparation method thereof, wherein the digestive tract leaking stoppage support comprises a degradable support body and a degradable covering film; the degradable tectorial membrane covers the degradable stent body; the bracket body is provided with a plurality of raised barbs; the degradable coating surface is provided with barbs. The degradable silk and the polylactic acid film are respectively used as the raw materials of the stent and the covering film, so that the tissue compatibility is good, and the foreign body sensation of the stent is less. The support body and the covering film are provided with a plurality of raised barbs, so that the support is effectively prevented from shifting.

Description

Biodegradable digestive tract leaking stoppage support and preparation method thereof

Technical Field

The invention relates to the technical field of digestive tract stents, in particular to a biodegradable digestive tract leaking stoppage stent and a preparation method thereof.

Background

Stent intervention has found numerous applications in the clinic of vascular surgery, thoracic surgery, urology, and digestive surgery. By utilizing medical imaging equipment such as X-ray fluoroscopy, CT positioning, B-ultrasonic and the like and by means of special catheters or instrument introduction, an interventional therapist can already deliver the stent to almost all blood vessel branches, digestive tract lumens and other specific focus parts of a human body.

The currently used interventional stents are mainly metal non-degradable stents, such as nitinol stents, which have the advantages that nitinol has shape memory and the stent can recover deformation at body temperature, thereby providing sufficient expansion and support force to the lesion site. However, its disadvantages are also evident, such as: (1) The non-degradable metal stent is used as a foreign body of a human body, has poor adaptability with the human body, and is easy to cause long-term complications such as continuous pain, foreign body inflammatory reaction, intimal hyperplasia, late thrombosis and the like; (2) If the non-degradable metal stent needs to be taken out, secondary operation is needed, so that the pain, the risk and the medical expense of a patient are increased; (3) If the non-degradable metal stent slips to the intestines and stomach or other parts, medical accidents such as internal injury, bleeding and even perforation can be caused.

Therefore, non-degradable metal stents are currently used in the field of the digestive system mainly in some palliative treatments of patients with advanced tumors, while for some benign strictures or obstructions, such as digestive tract disorders caused by achalasia, huge diverticula, etc., permanent metal stents are not suitable to be placed in the treatment. Benign stenotic lesions require removal of the stent after treatment is complete, which is not met by non-degradable metal stents.

Disclosure of Invention

The invention aims to provide a biodegradable digestive tract leaking stoppage support.

In order to solve the technical problems, the invention adopts the following technical scheme: a biodegradable digestive tract leaking stoppage support comprises a degradable support body and a degradable covering film; the degradable covering film is covered on the degradable stent body; the bracket body is provided with a plurality of raised barbs; the degradable tectorial membrane surface be provided with the barb.

Furthermore, the degradable coating film is a polylactic acid film.

Further, the degradable stent body is woven by polydioxanone wires.

Further, the periphery and one end of the degradable stent body are covered by the degradable covering film or the periphery and two ends of the degradable stent body are covered by the degradable covering film.

Furthermore, the whole degradable stent body is of a dumbbell-shaped structure and comprises a stent main body in the middle and support bodies at two ends; the diameter of the support body is larger than that of the support main body.

Furthermore, the stent main body and the support body are both of a rhombic net structure.

Further, the outer end of the supporting body is provided with an elastic supporting ring.

The invention also provides a preparation method of the biodegradable digestive tract leaking stoppage support, which comprises the steps of cutting the surface of the degradable filaments by using a cutting tool to form barbs of small thorn-shaped bulges, and weaving the degradable filaments with the barbs to form a support body; then cut out a plurality of barbs on the degradable tectorial membrane surface through cutting tool, at last with the periphery of degradable tectorial membrane cladding at the support body.

Further, after the stent body is woven, the elastic support bodies are woven into both ends of the stent body.

The invention has the beneficial effects that: .

The degradable silk and the polylactic acid film are respectively used as the raw materials of the stent and the covering film, so that the tissue compatibility is good, and the foreign body sensation of the stent is less.

The support body and the covering film are provided with a plurality of raised barbs, so that the support is effectively prevented from shifting.

The invention adopts poly-p-dioxanone thread, which not only has good tissue compatibility, but also can maintain the tensile strength for more than 40 days.

The polylactic acid film has good compatibility and degradability, and has the best tensile strength and ductility.

Drawings

The invention is further illustrated by the following figures and examples.

Fig. 1 is a schematic structural view of the present invention.

Fig. 2 is a partial schematic view of a stent body of the present invention.

FIG. 3 is a schematic view of a degradable silk delivery channel of the present invention.

Fig. 4 is a schematic view of the position of the cutting knife.

Fig. 5 is a schematic view of a cutting knife structure.

Detailed Description

The technical solution of the present invention will be clearly and completely described by the following detailed description.

In the description of the present invention, it is to be understood that the terms "middle", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, should not be construed as limiting the present invention. The terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

In addition, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are intended to be inclusive and mean, for example, that there may be a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature "on," "above" and "over" the second feature may include the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

Referring to fig. 1 and 2, the biodegradable digestive tract leaking stoppage stent comprises a degradable stent body 1 and a degradable covering film 03; the degradable tectorial membrane 03 covers on the degradable stent body 1. The degradable stent body 1 is provided with a plurality of raised barbs 2. The surface of the degradable tectorial membrane 03 is provided with barbs 2. The degradable stent body 1 adopts poly (p-dioxanone) thread. The degradable coating film 03 of the present invention is a polylactic acid film. Barb and support body integrated into one piece on the support body, barb on degradable tectorial membrane 03 surface also with degradable tectorial membrane integrated into one piece.

According to the invention, the degradable stent body 1 and the degradable coating 03 are provided with a plurality of barbs, so that the stent is effectively prevented from shifting.

The stent main body and the support body are both of a rhombic net structure. The main body of the diamond-shaped net-shaped structure of the stent endows the stent with larger radial supporting force and good axial compliance.

The whole bracket body of the invention is in a dumbbell-shaped structure and comprises a bracket main body 11 in the middle and supporting bodies 12 at two ends; the diameter of the support body is larger than that of the support main body. The support body with the dumbbell-shaped structure can prevent the support from shifting.

The outer end of the support body of the invention is provided with an elastic support ring 13. The elastic support ring arranged at the outer end of the support body can ensure that the displacement support is well attached to the side wall of the digestive tract, and the support body can be quickly recovered after being deformed.

Example 2

The invention adopts a cutting tool to cut the surface of the degradable filament to form barbs with small thorn-shaped protrusions, weaves the degradable filament with barbs to form a stent body, then cuts a plurality of barbs on the surface of the degradable film through the cutting tool, and finally coats the degradable film on the periphery of the stent body. After the stent body is knitted, the elastic support bodies are knitted into both ends of the stent body. The barbs of the small thorn-shaped bulges are spirally distributed on the surface of the degradable filament.

The shearing angle of the barb is 145-175 degrees, the shearing depth is one third of the diameter of the degradable filament, and the shearing length is generally equal to or slightly larger than the diameter of the degradable filament.

In order to achieve a better displacement prevention effect, the inclination directions of two adjacent barbs are opposite.

As shown in fig. 3-5, the present invention employs four cutting knives 3 to cut the surface of the degradable filaments, and the degradable filaments are conveyed through the degradable filament conveying passage; one end of the degradable silk conveying channel is a degradable silk winding shaft, the other end of the degradable silk unwinding shaft is a degradable silk unwinding shaft, and the winding shaft and the unwinding shaft are both driven by a motor.

The degradable silk conveying channel consists of limiting rings 41 at two ends and four connecting rods 42 for connecting the limiting rings at the two ends, wherein the four connecting rods are uniformly distributed; be cutting region 43 between two adjacent connecting rods, four connecting rods divide into four cutting regions with degradable silk transfer passage, all set up in one cutting 3 swords in every cutting region, and four cutting knife 3 distribute in proper order from the front to the back.

The cutting knife 3 of the invention is arranged on a knife seat 5, and the knife seat 5 is driven by a cutting driving device 6 to cut. According to the invention, the limit stops 7 are further arranged on two sides of the tool apron 5, the limit stops 7 are provided with adjusting components for adjusting the distance of the limit stops 7 extending out of the tool apron, so that the cutting depth of the cutting knife is adjusted, and after the driving device drives the tool apron to cut, the limit stops 7 can be clamped on the connecting rods on two sides of a cutting area, so that the cutting knife is prevented from being inserted too deeply.

According to the invention, the periphery of a cylinder is coated with the degradable coating, the outer diameter of the cylinder is equal to the inner diameter of the degradable filament conveying channel, the cylinder coated with the degradable coating is placed into the degradable filament conveying channel, and then four cutting knives are used for cutting, so that barbs are formed on the surface of the degradable coating.

While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the spirit and scope of the invention.

Claims

1. A preparation method of a biodegradable digestive tract leaking stoppage support is characterized by comprising the following steps: the biodegradable digestive tract leaking stoppage support comprises a degradable support body and a degradable covering film; the degradable tectorial membrane covers the degradable stent body; the bracket body is provided with a plurality of raised barbs; the preparation method of the biodegradable digestive tract leaking stoppage support comprises the following steps: cutting the surface of the degradable filament by using a cutting tool to form barbs with small thorn-shaped protrusions, and weaving the degradable filament with the barbs to form a support body; then cut out a plurality of barbs through cutting tool on degradable tectorial membrane surface, at last with the periphery of degradable tectorial membrane cladding at the support body, specifically do: conveying the degradable filaments through the degradable filament conveying channel; one end of the degradable filament conveying channel is a degradable filament winding shaft, the other end of the degradable filament conveying channel is a degradable filament unwinding shaft, and the winding shaft and the unwinding shaft are both driven by a motor; the degradable silk conveying channel consists of limiting rings (41) at two ends and four connecting rods (42) for connecting the limiting rings at the two ends, and the four connecting rods are uniformly distributed; a cutting area (43) is arranged between every two adjacent connecting rods, the degradable filament conveying channel is divided into four cutting areas by the four connecting rods, a cutting knife (3) is arranged in each cutting area, and the four cutting knives (3) are sequentially distributed from front to back; the cutting knife (3) is arranged on the knife holder (5), and the knife holder (5) is driven by the cutting driving device (6) to cut; the two sides of the cutter holder (5) are also provided with limit stops (7), the limit stops (7) are adjusted by the adjusting component to extend out of the cutter holder, so that the cutting depth of the cutting knife is adjusted, after the driving device drives the cutter holder to cut, the limit stops (7) can be clamped on connecting rods on the two sides of a cutting area, and the degradable filaments pass through the degradable filament conveying channel to form the degradable filaments with barbs; weaving the degradable filaments with the barbs to form a stent body; coating the degradable coating film on the periphery of a cylinder, wherein the outer diameter of the cylinder is equal to the inner diameter of a degradable wire conveying channel, placing the cylinder coated with the degradable coating film into the degradable wire conveying channel, and then cutting by using four cutting knives to form barbs on the surface of the degradable coating film; coating the degradable film on the periphery of the stent body; after weaving the bracket body, weaving the elastic supporting bodies into the two ends of the bracket body to manufacture the biodegradable digestive tract leaking stoppage bracket.