CN113509290A

CN113509290A - Biliary tract stent, sealed storage box and loader

Info

Publication number: CN113509290A
Application number: CN202110781793.5A
Authority: CN
Inventors: 陈坤; 崔毅杰; 张昱昕
Original assignee: Lepu Medical Technology Beijing Co Ltd
Current assignee: Lepu Medical Technology Beijing Co Ltd
Priority date: 2021-07-09
Filing date: 2021-07-09
Publication date: 2021-10-19

Abstract

The invention relates to the technical field of medical equipment, in particular to a biliary tract stent, a sealed storage box and a loader. A biliary stent, comprising: the stent braiding body is made of a fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the biliary tract. By providing the biliary stent with a majority of degradable materials having self-expanding properties. Thereby solve current biliary tract support still need take back, improved the loaded down with trivial details degree of operation, increased the painful problem of disease simultaneously.

Description

Biliary tract stent, sealed storage box and loader

Technical Field

The invention relates to the technical field of medical equipment, in particular to a biliary tract stent, a sealed storage box and a loader.

Background

Biliary stricture is one of the common obstructive diseases, and a stent is usually adopted for interventional therapy clinically. After the stent is implanted into the biliary tract, the biliary tract stent is used for expanding and supporting a narrow biliary tract lumen, thereby relieving biliary tract obstruction and keeping the biliary tract smooth. The operation has the advantages of high safety, reliable curative effect and few complications.

In the prior art, for example, patent document No. CN2424786Y discloses: a high contrast biliary tract stent is a latticed stent woven by metal wire materials, wherein the latticed stent is a latticed stent woven by stainless steel wire materials or a latticed stent woven by ferronickel alloy wires, and heavy metals of gold and silver are added on the surfaces of the wires. The biliary stent cannot be completely degraded after an operation is performed. The biliary stent also needs to be retrieved again by medical workers. The work of taking out the biliary tract stent in the secondary operation not only improves the complexity of the operation, but also increases the pain of patients. Therefore, there is a need in the art for a degradable biliary stent that solves the above problems.

Disclosure of Invention

The invention aims to solve the technical problem that the biliary tract stent in the prior art can not realize full degradation, so that the biliary tract stent needs secondary operation and retrieval, thereby improving the complexity of the operation and increasing the pain of patients, and the invention provides a biliary tract stent for solving the problems, which comprises the following components:

the stent braiding body is made of a fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the biliary tract.

Optionally, the biliary stent further includes:

the stent protection tectorial membrane, the tectorial membrane is degradable material, and the cladding is in the support braid surface is in order to the cladding the support braid support wire rod surface and the adjacent support wire rod crossing point position of body, thereby support the stent protection tectorial membrane stable in structure.

Optionally, the stent protection covering film is made of a high polymer material with shape memory performance, and the stent braid deforms at 35-40 ℃ so that the stent protection covering film rebounds to the working size of the stent in the contraction state.

Optionally, the composition materials of the stent protection covering membrane include: modified polycaprolactone and/or crosslinked polylactic acid.

Optionally, the stent wire is a degradable wire; the degradable wire comprises: at least one of polydioxanone, polylactic acid, polyethylene glycol, polycaprolactone, degradable polyurethane, polytrimethylene carbonate, polylactic acid-ethylene glycol copolymer, polylactide-polyethylene glycol copolymer, and 3/4-hydroxybutyrate.

Optionally, the stent braid comprises: the main body part is of a columnar structure, and open type flaring openings are arranged at two ends of the main body part; the open type flaring extends towards the direction far away from the main body part and is used for fixing the biliary tract stent.

Optionally, the length of the main body part ranges from 50mm to 110mm, and the outer diameter of the main body part ranges from 8mm to 10 mm; and/or the presence of a gas in the gas,

the included angle between the extension line of the main body part and the open type flaring is 0-45 degrees, and the length of the open type flaring is 5 mm.

Optionally, the stent protective coating of the main body portion and the open flare interface has a developer coating for X-ray visualization; and/or the presence of a gas in the gas,

and a metal developing ring is arranged at the joint of the main body part and the open type flaring for X-ray development.

The surface of the stent protective coating is provided with anti-inflammatory and anti-infective drugs to inhibit biliary hyperplasia.

A sealed storage box is used for storing the biliary tract stent, and the biliary tract stent is in a release state in the sealed storage box.

A loader for a biliary stent, the loader being for loading a biliary stent into a biliary cavity;

the loader includes: the biliary tract stent is accommodated in the connecting pipe; and a traction rope for loading the biliary tract stent is arranged on the open flaring;

the traction rope is used for drawing the biliary tract stent, so that the biliary tract stent passes through the loading funnel and is loaded into the connecting pipe in a pressing and holding manner.

The technical scheme of the invention has the following advantages:

1. the biliary stent of the present invention includes: the stent braiding body is made of a fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of the biliary tract.

In the invention, the biliary tract stent is made of most degradable materials with self-expansion performance, and can be completely degraded within 6 to 12 months after being implanted, so that the biliary tract stent can be completely degraded in a living body, thereby solving the problems that the existing biliary tract stent needs to be taken back, the complexity of an operation is improved, and the pain of a patient is increased. In addition, the biliary tract stent is a shape memory biliary tract stent with complete self-expansion capability, and the memory biliary tract stent with self-expansion performance is applied to a narrow biliary tract cavity, so that stable support protection can be effectively provided for the biliary tract cavity within a period of time, and the smoothness of the biliary tract is ensured. Moreover, the biliary tract stent has self-expansion performance, can be automatically expanded to a standard size after being released by the delivery system, does not need balloon assistance, and effectively reduces the difficulty of operation.

2. The biliary stent of the present invention further comprises: the stent protection tectorial membrane, the tectorial membrane is degradable material, and the cladding is in the support braid surface is in order to the cladding the support braid support wire rod surface and the adjacent support wire rod crossing point position of body, thereby support the stent protection tectorial membrane stable in structure.

In the invention, the stent protective coating is a degradable material and is coated on the surface of the stent braid, so that the stent wires of the stent braid are fixedly protected, the stent protective coating is a partially crosslinked and partially modified degradable polymer, most of the biodegradable polymer can be absorbed, and a small amount of residual gel network can be discharged out of the body along with digestive juice. The stent protective coating can also delay the degradation of stent wires used for the stent weaving, thereby ensuring more durable mechanical support and protecting the stent wires.

3. According to the biliary tract stent, the stent protection covering membrane is made of a high polymer material with shape memory performance, and the stent braid deforms at 35-40 ℃ so that the stent protection covering membrane rebounds to the working size of the stent in a contraction state.

In the invention, the stent protective covering film deforms at 35-40 ℃, and the temperature is the temperature in a living body, so that the stent protective covering film spontaneously deforms after entering the living body, the contracted state of the stent protective covering film rebounds to the working size of the stent, and the stent braid body is assisted to smoothly release rebounding.

4. The biliary stent of the present invention includes: the main body part is of a columnar structure, and open type flaring openings are arranged at two ends of the main body part; the open type flaring extends towards the direction far away from the main body part and is used for fixing the biliary tract stent.

The biliary tract stent is fixed on the biliary tract cavity by arranging the outward-expanding open type flaring at the two ends of the stent braiding body, so that the biliary tract stent is prevented from moving. Meanwhile, the biliary tract stent can be released and temporarily recovered through the open type flaring.

5. In the biliary stent of the present invention, the stent protective coating at the junction of the main body portion and the open type flaring has a developer coating for X-ray development; and/or a metal developing ring is arranged at the joint of the main body part and the open type flaring for X-ray development.

The stent protective coating has a developer coating, and a metal developing ring is arranged at the joint of the main body part and the open type flaring.

6. The biliary tract stent has the advantages that the anti-inflammatory and anti-infective medicaments are arranged on the surface of the protective coating of the biliary tract stent, so that biliary tract hyperplasia is inhibited.

The anti-inflammatory and anti-infective medicaments are sprayed on the surface of the stent protective coating, so that the stent can be effectively assisted in treatment, and the hyperplasia in the biliary tract can be inhibited, thereby further ensuring the smoothness of the biliary tract cavity.

7. The sealed storage box is used for storing the biliary tract stent, and the biliary tract stent is in a release state in the sealed storage box.

The sealed storage box can effectively seal and store the biliary tract stent so as to protect the stent braid and the stent protective covering film. In addition, the device is not suitable for maintaining a pressing and holding state for a long time due to the characteristics of the high polymer material of the stent braiding body, and the device is in a release state when the biliary tract stent is stored in the sealed storage box, so that the permanent deformation caused by material creep and stress relaxation is weakened as much as possible.

8. The loader for the biliary tract stent is used for loading the biliary tract stent into a biliary tract cavity; the loader includes: the biliary tract stent is accommodated in the connecting pipe; and a traction rope for loading the biliary tract stent is arranged on the open flaring; the traction rope is used for drawing the biliary tract stent, so that the biliary tract stent passes through the loading funnel and is loaded into the connecting pipe in a pressing and holding manner.

The use method of the loader comprises the following steps: and a traction rope penetrates into the loading funnel and penetrates out of the connecting pipe, so that the biliary tract stent is pulled through the traction rope, passes through the loading funnel and is loaded into the connecting pipe in a pressing and holding manner. The connecting pipe is nested with the conveying system, so that the biliary tract stent is placed into the conveying system, and the traction rope is cut off and taken away after the biliary tract stent is loaded.

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, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic perspective view of a biliary tract stent provided by the present invention;

FIG. 2 is a schematic view of the connection of the stent protective cover and the stent wire provided by the present invention;

FIG. 3 is a schematic view of a stent braid with a pull cord according to the present invention;

fig. 4 is a schematic perspective view of the loader according to the present invention.

Description of reference numerals:

1-a stent braid; 2-stent protection coating; 3-a body portion; 4-open type flaring; 5-a stent wire; 6-a loader; 7-connecting pipe; 8-loading the funnel; 9-a traction rope.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either 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 in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

As shown in fig. 1, a biliary stent in this embodiment includes:

the stent braiding body 1 is made of a fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of a biliary tract; the stent wire 5 is a degradable wire; the degradable wire comprises: at least one of polydioxanone, polylactic acid, poly (glycolide), polycaprolactone, degradable polyurethane, poly (trimethylene carbonate), poly (lactic acid-co-ethylene glycol), poly (lactide-co-glycolide), and 3/4-hydroxybutyrate;

the stent protection coating 2 is made of degradable materials and coated on the surface of the stent braiding body 1 as shown in fig. 2, so as to coat the surface of the stent wire 5 of the stent braiding body 1 and the position of the cross point of the adjacent stent wire, thereby supporting the stent protection coating 2 to be stable in structure. In this embodiment, the stent protective coating 2 is made of a polymer material with a shape memory property, and the stent braid 1 deforms at about 37 ℃, so that the stent protective coating 2 rebounds to the working size of the stent in the contracted state. The temperature is the temperature in the organism, so that the stent protective covering film 2 deforms after entering the organism, the stent protective covering film 2 rebounds to the working size of the stent in the contraction state, and the stent braiding body 1 is assisted to smoothly release the rebounding; the composition materials of the stent protective coating 2 comprise: modified polycaprolactone and crosslinked polylactic acid; in addition, the surface of the stent protective covering membrane 2 is provided with anti-inflammatory and anti-infective drugs to inhibit the hyperplasia in the biliary tract.

The biliary stent is completely degradable within 6 months after being implanted by setting the biliary stent into a completely degradable material with self-expansion performance, so that the complete degradation of the biliary stent in a living body is realized, the problem that the existing biliary stent still needs to be taken back is solved, the complexity of operation is improved, and the pain of patients is increased. In addition, the biliary tract stent is a shape memory biliary tract stent with complete self-expansion capability, and the memory biliary tract stent with self-expansion performance is applied to a narrow biliary tract cavity, so that stable support protection can be effectively provided for the biliary tract cavity within a period of time, and the smoothness of the biliary tract is ensured. Moreover, the biliary tract stent has self-expansion performance, can be automatically expanded to a standard size after being released by the delivery system, does not need balloon assistance, and effectively reduces the difficulty of operation.

In the present embodiment, as shown in fig. 1, the stent braid 1 includes: a main body portion 3 of a columnar structure, and open-type flares 4 provided at both ends of the main body portion 3; the open type flaring 4 extends towards the direction far away from the main body part 3 and is used for fixing the biliary tract stent. And, the length of the body portion 3 ranges from 70mm, and the outer diameter of the body portion 3 ranges from 9 mm; an included angle between the extension line of the main body part 3 and the open type flaring 4 is 30 degrees, and the length of the open type flaring 4 is 1 mm. The stent protective coating 2 at the intersection of the main body portion 3 and the open flares 4 has a developer coating for X-ray development.

Of course, the deformation temperature of the stent braid 1 is not specifically limited in this embodiment, in other embodiments, the stent protective cover 2 is made of a polymer material with a shape memory property, and the stent braid 1 deforms at 35 to 40 degrees celsius, so that the stent protective cover 2 rebounds to the working size of the stent in the contracted state.

Of course, the structural size of the biliary tract stent is not specifically limited in this embodiment, and in other embodiments, the length range of the main body portion 3 is 58mm, and the outer diameter range of the main body portion 3 is 8 mm; the included angle between the extension line of the main body part 3 and the open type flaring 4 is 45 degrees, and the length of the open type flaring 4 is 0.5 mm.

Of course, the present embodiment does not specifically limit the X-ray developing method of the biliary stent, and in other embodiments, a metal developing ring is disposed at the junction of the main body portion 3 and the open-type flaring 4 for X-ray developing.

Example 2

A sealed storage case for storing a biliary stent in a released state within the sealed storage case. The sealed storage box can effectively seal and store the biliary tract stent to protect the stent braid 1 and the stent protective cover 2. In addition, the device is not suitable to be held for a long time due to the characteristics of the polymer material of the stent braid 1, and is in a release state when the biliary stent is stored in the sealed storage box, so as to weaken the permanent deformation caused by material creep and stress relaxation as much as possible.

Example 3

As shown in fig. 4, the loader 6 is used to load the biliary stent into the biliary tract cavity; the loader 6 includes: the biliary tract stent comprises a connecting pipe 7 and a loading funnel 8 arranged at the end part of the connecting pipe 7, wherein the biliary tract stent is accommodated in the connecting pipe 7; moreover, a traction rope 9 for loading the biliary tract stent is arranged on the open type flaring 4; the hauling cable 9 is used for hauling the biliary tract stent, so that the biliary tract stent is pressed and held to be loaded into the connecting pipe 7 through the loading funnel 8.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. A biliary stent, comprising:

the stent braiding body (1) is made of a fully degradable material and has a net structure with self-expansion performance so as to provide continuous circumferential support for the inner wall of a biliary tract.

2. The biliary stent of claim 1, further comprising:

support protection tectorial membrane (2), the tectorial membrane is degradable material, the cladding is in body (1) surface is woven to the support, with the cladding support wire rod (5) surface and adjacent support wire rod crossing point position that body (1) was woven to the support, thereby support protection tectorial membrane (2) stable in structure.

3. The biliary stent according to claim 2, wherein the stent protection cover (2) is a polymer material with shape memory properties, and the stent braid (1) is deformed at 35-40 ℃ to allow the stent protection cover (2) to rebound to a stent working size in a contracted state.

4. Biliary stent according to claim 3, wherein the stent protection coating (2) consists of materials comprising: modified polycaprolactone and/or crosslinked polylactic acid.

5. The biliary stent according to claim 1, wherein the stent wire (5) is a degradable wire; the degradable wire comprises: at least one of polydioxanone, polylactic acid, polyethylene glycol, polycaprolactone, degradable polyurethane, polytrimethylene carbonate, polylactic acid-ethylene glycol copolymer, polylactide-polyethylene glycol copolymer, and 3/4-hydroxybutyrate.

6. The biliary stent according to claim 2, wherein the stent braid (1) comprises: a main body part (3) of a columnar structure, and open type flaring openings (4) arranged at two ends of the main body part (3); the open type flaring opening (4) extends towards the direction far away from the main body part (3) and is used for fixing the biliary tract stent.

7. The biliary stent according to claim 6, wherein the length of the main body portion (3) ranges from 50mm to 110mm, and the outer diameter of the main body portion (3) ranges from 8mm to 10 mm; and/or the presence of a gas in the gas,

the included angle between the extension line of the main body part (3) and the open type flaring (4) is 0-45 degrees, and the length of the open type flaring (4) is 5 mm.

8. The biliary stent according to claim 6, wherein the stent protection coating (2) at the intersection of the main body portion (3) and the open flares (4) has a coating of a developer for X-ray visualization; and/or the presence of a gas in the gas,

and a metal developing ring is arranged at the joint of the main body part (3) and the open type flaring (4) and is used for X-ray development.

9. The biliary stent of claim 6,

the surface of the stent protective covering film (2) is provided with anti-inflammatory and anti-infective drugs to inhibit hyperplasia in the biliary tract.

10. A sealed storage case for storing the biliary stent of any one of claims 1 to 9, wherein the biliary stent is in a released state within the sealed storage case.

11. A loader for a biliary stent, wherein the loader (6) is for loading a biliary stent according to any one of claims 1 to 9 into a biliary lumen;

the loader (6) comprises: the biliary stent comprises a connecting pipe (7) and a loading funnel (8) arranged at the end part of the connecting pipe (7), wherein the biliary stent is accommodated in the connecting pipe (7); moreover, a traction rope (9) for loading the biliary tract stent is arranged on the open type flaring (4);

the traction rope (9) is used for drawing the biliary tract stent, so that the biliary tract stent is pressed and held to be loaded into the connecting pipe (7) through the loading funnel (8).