CN116898646A

CN116898646A - Intragastric self-expanding stent and method of use thereof

Info

Publication number: CN116898646A
Application number: CN202310969460.4A
Authority: CN
Inventors: 周叶
Original assignee: Suzhou Huizhi Yinghua Medical Technology Co ltd
Current assignee: Suzhou Huizhi Yinghua Medical Technology Co ltd
Priority date: 2023-08-03
Filing date: 2023-08-03
Publication date: 2023-10-20

Abstract

The invention discloses an intragastric self-expanding stent and a method of using it, which includes a self-expanding stent body and a degradable wrapping layer. The self-expanding stent body is wrapped inside the degradable wrapping layer; the degradable wrapping layer It is located in the stomach and degrades, causing the self-expanding stent body to expand and expand to form a braided structure and adhere to the inner wall of the stomach; the expansion force of the self-expanding stent body against the inner wall of the stomach is 3-15N and the compressive strength is 3- 15N/cm ² , tensile strength 3‑10N. The intragastric self-expanding stent used in this device is used to support the stomach of obese patients to increase satiety and reduce gastric food intake, thereby achieving weight loss.

Description

Intragastric self-expanding stent and application method thereof

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to an intragastric self-expanding stent and a use method thereof.

Background

The stomach, an important component of human organs, is mainly doubly innervated by the Central Nervous System (CNS), the Enteric Nervous System (ENS). And the current living conditions are gradually improved, so that the stomach diseases with various causes are caused by the influence of diseases, diet, environment and the like, and if diagnosis and treatment are not performed in time, stomach cancer can be caused.

Particularly for obese patients, the gastric cavity volume of the crowd is larger, so that the people can only be satisfied with the condition that the food amount is larger every time, and for losing weight, the obese patients can reduce the food amount (i.e. diet) to achieve the effect of losing weight, but the long-term diet mode can lead to the abnormal operation of the gastrointestinal tract, thereby affecting the peristalsis of the gastrointestinal tract and the normal digestion function, and even possibly inducing diseases such as gastritis.

The patent application number 201710182439.4 discloses a gastric spherical bracket which is made of metal alloy wires and comprises an upper circle, a lower circle, bone warps and bone wefts, wherein the upper circle and the lower circle are oppositely arranged, and the bone warps are arranged at intervals in an arc shape, so that the gastric spherical bracket is convenient to take out at any time under the assistance of a gastroscope and can be repeatedly used. However, since the stomach of each patient is not the same, the device is directly reused, which not only brings bad treatment effect to the patient, but also causes the problems of mismatching of positions and limited treatment effect.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a self-expanding stent in the stomach and a use method thereof, which solve the technical problems in the prior art.

The aim of the invention can be achieved by the following technical scheme:

the intragastric self-expanding stent comprises a self-expanding stent body and a degradable wrapping layer, wherein the self-expanding stent body is wrapped in the degradable wrapping layer;

the degradable wrapping layer is positioned in the stomach to form degradation, so that the self-expanding stent body is expanded and unfolded to form a woven structure and is attached to the inner wall of the stomach;

wherein the self-expanding stent body forms the inner wall of the stomach with the unfolding force of 3-15N and the compressive strength of 3-15N/cm ² The tensile strength is 3-10N.

Furthermore, the self-expanding stent body is made of PLA or PLGA materials.

Further, the degradable coating layer is made of PLGA or magnesium alloy materials.

Further, the diameter of the braided wire formed by the expanding is 0.2-1mm.

Further, the diameter of the self-expanding bracket body is less than or equal to 5mm when the self-expanding bracket body is contracted in the degradable wrapping layer, and the length of the self-expanding bracket body is less than or equal to 5mm.

Further, the degradable coating layer is contacted with gastric acid and degrades within 30 seconds.

Further, the self-expanding stent body is unfolded in a spherical braiding structure after being released, so that the spherical braiding structure is connected by braiding wires which are interwoven with each other.

Further, the self-expanding stent body has a variable dimension of 20-100mm after being released.

Further, the self-expanding stent body has a degradation time of 10-25 days in the stomach.

The application method of the intragastric self-expanding stent comprises the following steps:

s1, firstly, implanting a degradable wrapping layer wrapped with a self-expanding stent body into the stomach;

s2, decomposing the degradable wrapping layer by gastric acid within 30 seconds, and synchronously realizing the unfolding and expansion of the self-expanding stent body until the degradable wrapping layer contacts with the interior of the gastric wall to form specified tension;

and S3, the self-expanding stent body is self-expanded and unfolded until the self-expanding stent body is stored for 10 to 15 days and then degraded.

The invention has the beneficial effects that:

1. the intragastric self-expanding bracket adopted by the device is used for increasing satiety after supporting in the stomach of an obese patient, and reducing the feeding amount of the stomach, thereby achieving the effect of weight reduction.

2. The self-expanding stent body adopted by the device is made of PLA or PLGA materials, and can be explained in a certain time, namely, the self-expanding stent body is degraded after being continuously stored in the stomach for 10-25 days, secondary taking is not needed, and the experience is good.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below.

FIG. 1 is a schematic diagram of an overall package state structure according to an embodiment of the present invention;

FIG. 2 is a schematic view showing the structure of the self-expanding stent body according to the embodiment of the present invention in an expanded state;

FIG. 3 is a schematic top view of a self-expanding stent body according to an embodiment of the present invention;

fig. 4 is a schematic side view of a self-expanding stent body according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

As shown in fig. 1 and 2, the embodiment of the invention provides a self-expandable stent in stomach, which comprises a self-expandable stent body 2 and a degradable wrapping layer 1, wherein the self-expandable stent body 2 is wrapped in the degradable wrapping layer 1, and the diameter of the self-expandable stent body 2 is less than or equal to 5mm and the length of the self-expandable stent body is less than or equal to 5mm when the self-expandable stent body 2 is contracted in the degradable wrapping layer 1. The self-expanding stent body 2 is made of PLA material (polylactide material) or PLGA material (polylactic acid-glycolic acid copolymer), which has good biocompatibility, is non-toxic, has good properties of encapsulation and film formation, and exhibits a wider solubility, and is soluble in more solvents. The degradable coating layer 1 is made of PLGA (polylactic acid-glycolic acid copolymer) or magnesium alloy material (because the coating layer of the outer layer is thinner, the coating layer directly falls off under the action of gastric acid after entering the stomach, and the coated self-expanding stent body 2 is automatically unfolded), and the degradable coating layer 1 is contacted with gastric acid and is degraded within 30 seconds.

The diameter of the braiding wires formed by the expansion of the self-expanding stent body 2 is 0.2-1mm, the self-expanding stent body 2 is expanded in a spherical braiding structure after being released, so that the spherical braiding structure is connected with braiding wires which are interwoven with each other, the changing size after being released is 20-100mm, and the self-expanding stent is specifically customized according to the stomach size of a patient.

The degradable wrapping layer 1 is positioned in the stomach to form degradation, so that the self-expanding stent body 2 is expanded and unfolded to form a woven structure and is attached to the inner wall of the stomach;

as shown in fig. 3 and 4, the self-expanding stent body 2 has a deployment force of 3-15N and a compressive strength of 3-15N/cm on the inner wall of the stomach ² The tensile strength is 3-10N.

The degradation time of the self-expanding stent body 2 in the stomach is 10-25 days.

The using method of the intragastric self-expanding stent comprises the following steps:

s1, firstly, the degradable wrapping layer 1 wrapped with the self-expanding stent body 2 is implanted into the stomach from the beginning, and can be taken in a swallow mode and directly implanted into the stomach of a patient.

S2, decomposing the degradable wrapping layer 1 by gastric acid within 30 seconds, and synchronously realizing the unfolding and expansion of the self-expanding stent body 2 until the degradable wrapping layer contacts with the interior of the stomach wall (i.e. is attached to the interior of the stomach wall) to form a specified tension; wherein the unfolding force is 3-15N, and the compressive strength is 3-15N/cm ² The tensile strength is 3-10N.

S3, the self-expanding stent body 2 is self-expanded and unfolded until the stent body is stored for 10 to 25 days and then degraded.

The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims.

Claims

1. A self-expanding intragastric stent, characterized in that it consists of a self-expanding stent body (2) and a degradable wrapping layer (1). The self-expanding stent body (2) is wrapped in a degradable wrapping layer. Layer(1)Inside;

The degradable wrapping layer (1) is located in the stomach and degrades, causing the self-expanding stent body (2) to expand and expand to form a braided structure and adhere to the inner wall of the stomach;

The self-expanding stent body (2) has a deployment force of 3-15N on the inner wall of the stomach, a compressive strength of 3-15N/cm ² , and a tensile strength of 3-10N.

2. The intragastric self-expanding stent according to claim 1, characterized in that the self-expanding stent body (2) is made of PLA or PLGA material.

3. The intragastric self-expanding stent according to claim 1, characterized in that the degradable wrapping layer (1) is made of PLGA or magnesium alloy material.

4. The intragastric self-expanding stent according to claim 1, wherein the diameter of the braided wire formed by the expansion is 0.2-1 mm.

5. The intragastric self-expanding stent according to claim 1, characterized in that, when the self-expanding stent body (2) is shrunk inside the degradable wrapping layer (1), its diameter is ≤ 5 mm and its length is ≤ 5 mm.

6. The intragastric self-expanding stent according to claim 1, characterized in that the degradable wrapping layer (1) contacts gastric acid and degrades within 30 seconds.

7. The intragastric self-expanding stent according to claim 1, characterized in that the self-expanding stent body (2) unfolds into a spherical braided structure after release, so that the spherical braided structure has interwoven braided wires. connect.

8. The intragastric self-expanding stent according to claim 1, characterized in that the size of the self-expanding stent body (2) after release is 20-100 mm.

9. The self-expanding stent in the stomach according to claim 1, characterized in that the degradation time of the self-expanding stent body (2) in the stomach is 10-25 days.

10. The method of using the intragastric self-expanding stent according to any one of claims 1 to 9, characterized in that it includes the following steps:

S1. First, implant the degradable wrapping layer (1) wrapped with the self-expanding stent body (2) into the stomach;

S2. The degradable wrapping layer (1) is decomposed by gastric acid within 30 seconds, and simultaneously realizes the unfolding and expansion of the self-expanding stent body (2) until it contacts the inside of the stomach wall to form a specified tension;

S3. The self-expanding stent body (2) expands from expansion to degradation after being stored for 10-25 days.