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

Abstract

The invention discloses a biodegradable digestive tract leak-stopping stent and a preparation method thereof. The digestive tract leak-stopping support includes a degradable stent body and a degradable coating; the degradable coating covers the degradable stent On the body; the stent body is provided with several protruding barbs; the surface of the degradable film is provided with barbs. The invention adopts degradable silk and polylactic acid film as the raw materials of the bracket and the covering membrane respectively, and has good tissue compatibility and less foreign body feeling of the bracket. Several protruding barbs are arranged on the stent body and the coating of the present invention to effectively prevent the stent from shifting.

Description

A biodegradable stent for plugging digestive tract leakage and its preparation method

technical field

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

Background technique

Stent interventional therapy has been widely used in vascular surgery, thoracic surgery, urology, and digestive surgery. Using X-ray fluoroscopy, CT positioning, B-ultrasound and other medical imaging equipment, through the introduction of special catheters or instruments, interventional doctors have been able to deliver stents to almost all blood vessel branches, digestive tract lumens and other specific lesions in the human body.

The currently used interventional stents are mainly metal non-degradable stents, such as nickel-titanium alloy stents. The advantage is that nickel-titanium alloys have shape memory, and the stents can recover from deformation at body temperature, thereby providing sufficient expansion and support for the lesion. But its disadvantages are also obvious, for example: (1) Non-degradable metal stents are foreign bodies in the human body, which are not well adaptable to the human body, and are likely to cause long-term complications such as persistent pain, foreign body inflammatory response, intimal hyperplasia, and late thrombosis; ( 2) If the non-degradable metal stent needs to be taken out, a second operation is required, which will increase the pain, risk and medical expenses of the patient; (3) If the non-degradable metal stent slips into the stomach or other parts, it will cause internal damage, bleeding, or even perforation, etc. medical malpractice.

Therefore, non-degradable metal stents are currently mainly used in the palliative treatment of patients with advanced tumors in the field of digestive system, and for some benign strictures or obstructions, such as achalasia of the cardia, giant diverticulum, etc. It is not suitable for permanent metal stent placement. Benign stenotic lesions require stent removal after treatment, and non-degradable metal stents cannot meet this requirement.

Contents of the invention

The technical problem to be solved by the present invention is to provide a biodegradable stent for plugging digestive tract leakage.

In order to solve the above technical problems, the present invention adopts the following technical solutions: a biodegradable digestive tract leak plugging stent, comprising a degradable stent body and a degradable coating; the degradable coating covers the degradable On the stent body; the stent body is provided with several protruding barbs; the surface of the degradable film is provided with barbs.

Further, the degradable film is a polylactic acid film.

Further, the degradable stent body is made of polydioxanone thread.

Further, the periphery and one end of the degradable stent body are covered with a degradable film, or the periphery and both ends of the degradable stent body are covered with a degradable film.

Further, the degradable stent body has a dumbbell-shaped structure as a whole, including a stent body in the middle and support bodies at both ends; the diameter of the support body is larger than that of the stent body.

Further, both the main body of the stent and the support body have a rhombic network structure.

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

The present invention also provides a preparation method of a biodegradable digestive tract plugging stent, which uses a cutting tool to cut the surface of the degradable wire to form small thorn-like protruding barbs, and weaves the degradable wire with the barbs, The stent body is formed; then a number of barbs are cut out on the surface of the degradable coating with a cutting tool, and finally the degradable coating is coated on the periphery of the stent body.

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

The beneficial effects of the present invention are:.

The invention adopts degradable silk and polylactic acid film as the raw materials of the bracket and the covering membrane respectively, which has good tissue compatibility and less foreign body feeling of the bracket.

Several protruding barbs are arranged on the stent body and the coating of the present invention to effectively prevent the stent from shifting.

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

The polylactic acid film of the invention has good compatibility and degradability, and has the best tensile strength and extensibility.

Description of drawings

The present invention will be further described below in conjunction with drawings and embodiments.

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

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

Fig. 3 is a schematic diagram of the delivery channel of the degradable silk of the present invention.

Figure 4 is a schematic diagram of the position of the cutting knife.

Fig. 5 is a schematic diagram of the structure of the cutting knife.

Detailed ways

The technical solutions of the present invention will be clearly and completely described below through specific embodiments.

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

In addition, terms such as "mounted", "connected", "connected" and "fixed" should be interpreted in a broad sense unless otherwise clearly specified and limited, for example, it may be a fixed connection or a detachable connection, or an integral Ground connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

In the present invention, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them. Moreover, "above", "above" and "above" the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature. "Below", "beneath" and "under" the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.

Referring to FIG. 1 and FIG. 2 , it is a biodegradable stent for digestive tract leakage plugging according to the present invention, which includes a degradable stent body 1 and a degradable coating 03 ; the degradable coating 03 covers the degradable stent body 1 . Several protruding barbs 2 are provided on the degradable stent body 1 . Barbs 2 are provided on the surface of the degradable coating 03 of the present invention. The degradable stent body 1 of the present invention adopts polydioxanone thread. The degradable film 03 of the present invention is a polylactic acid film. The barbs on the stent body are integrally formed with the stent body, and the barbs on the surface of the degradable coating 03 are also integrally formed with the degradable coating.

In the present invention, several barbs are arranged on the degradable stent body 1 and the degradable covering film 03 to effectively prevent the stent from shifting.

Both the stent main body and the support body of the present invention have a rhombus network structure. The main body of the stent with rhombic network structure endows the stent with greater radial support force and good axial compliance.

The stent body of the present invention has a dumbbell-shaped structure as a whole, including a stent body 11 in the middle and support bodies 12 at both ends; the diameter of the support body is larger than that of the stent body. The bracket body with a dumbbell-shaped structure can prevent the bracket from shifting.

The outer end of the support body of the present invention is provided with an elastic support ring 13 . The elastic supporting ring provided at the outer end of the supporting body of the present invention can make the displacement bracket fit well with the side wall of the digestive tract, and the supporting body can recover quickly after being deformed.

Example 2

In the present invention, a cutting tool is used to cut the surface of the degradable wire to form small thorn-like protruding barbs, and the degradable wire with the barbs is braided to form the stent body, and then cut out on the surface of the degradable film by a cutting tool A plurality of barbs, and finally wrap the degradable film on the periphery of the stent body. After weaving the stent body, the elastic support body is woven into both ends of the stent body. The barbs with small thorn-like protrusions are distributed on the surface of the degradable silk in a spiral rotation.

The shearing angle of the barbs of the present invention is 145-175°, the shearing depth is one-third of the diameter of the degradable wire, and the shearing length is generally equal to or slightly larger than the diameter of the degradable wire.

In order to achieve a better anti-displacement effect, in the present invention, the inclination directions of two adjacent barbs are opposite.

As shown in Figures 3-5, the present invention uses four cutting knives 3 to cut the surface of the degradable silk, and the degradable silk is transported through the degradable silk conveying channel; one end of the degradable silk conveying channel is the degradable silk Winding shaft, the other end is degradable silk unwinding shaft, both winding shaft and unwinding shaft are driven by motor.

The degradable wire conveying channel of the present invention is composed of stop rings 41 at both ends and four connecting rods 42 connecting the stop rings at both ends, the four connecting rods are evenly distributed; between two adjacent connecting rods is In the cutting area 43, four connecting rods divide the degradable wire conveying channel into four cutting areas, each cutting area is equipped with a cutting knife 3, and the four cutting knives 3 are distributed from front to back in sequence.

The cutting knife 3 of the present invention is installed on the knife seat 5, and the knife seat 5 is driven by the cutting driving device 6 to cut. The present invention also installs limit block 7 on both sides of knife seat 5, and limit stop block 7 has adjusting assembly to adjust the distance that it extends out of knife seat, thereby adjusts the cutting depth of cutting knife, when driving device drives knife seat to cut Finally, the limit stopper 7 can be stuck on the connecting rods on both sides of the cutting area to prevent the cutting knife from being inserted too deeply.

In the present invention, the degradable coating is coated on the outer periphery of a cylinder, the outer diameter of the cylinder is equal to the inner diameter of the degradable silk delivery channel, the cylinder coated with the degradable coating is placed in the degradable silk delivery channel, and then Cut with four cutting knives to form barbs on the surface of the degradable film.

The above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Those skilled in the art can make various modifications or equivalent replacements to the present invention within the essence and protection scope of the present invention. Or an equivalent replacement should also be deemed to fall within the protection scope of the technical solution of the present invention.

Claims (1)

1. A preparation method of a biodegradable digestive tract leak-stopping stent, characterized in that: the biodegradable digestive tract leak-stopping stent comprises a degradable stent body and a degradable coating; the degradable coating covers On the degradable stent body; several protruding barbs are set on the stent body; the preparation method of the biodegradable digestive tract leak-stopping stent is: cutting on the surface of the degradable wire with a cutting tool to form a small Barbs protruding like thorns, weave the degradable wire with barbs to form the stent body; then cut a number of barbs on the surface of the degradable coating with a cutting tool, and finally wrap the degradable coating on the stent body Specifically, the degradable silk is transported through the degradable silk conveying channel; one end of the degradable silk conveying channel is the degradable silk winding shaft, the other end is the degradable silk unwinding shaft, the winding shaft and the unwinding shaft Both are driven by motors; the degradable wire conveying channel is composed of limit rings (41) at both ends and four connecting rods (42) connecting the limit rings at both ends, and the four connecting rods are evenly distributed; the adjacent two The cutting area (43) is between the connecting rods, and the four connecting rods divide the degradable wire conveying channel into four cutting areas, each cutting area is equipped with a cutting (3) knife, and four cutting knives (3) Distributed sequentially from front to back; the cutting knife (3) is installed on the knife seat (5), and the knife seat (5) is driven by the cutting drive device (6) to cut; on both sides of the knife seat (5) there are The limit stopper (7) is installed, and the limit stopper (7) is adjusted by the adjustment component to extend the distance from the knife seat, thereby adjusting the cutting depth of the cutting knife. When the driving device drives the knife seat to cut, the limit stopper (7) It can be stuck on the connecting rods on both sides of the cutting area, and the degradable wire passes through the degradable wire conveying channel to form a degradable wire with barbs; weave the degradable wire with barbs to form the stent body ; Wrap the degradable film on the periphery of a cylinder, the outer diameter of the cylinder is equal to the inner diameter of the degradable silk delivery channel, put the cylinder covered with the degradable film into the degradable silk delivery channel, and then use Cut with four cutting knives to form barbs on the surface of the degradable coating; wrap the degradable coating on the outer periphery of the stent body; after weaving the stent body, weave elastic supports into both ends of the stent body to make Biodegradable stent for gastrointestinal leak plugging.

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