CN219070795U

CN219070795U - Metal biliary tract stent

Info

Publication number: CN219070795U
Application number: CN202222452975.0U
Authority: CN
Inventors: 帖军; 颜世平; 傅泽粮
Original assignee: APT MEDICAL Inc
Current assignee: APT MEDICAL Inc
Priority date: 2022-09-16
Filing date: 2022-09-16
Publication date: 2023-05-26
Anticipated expiration: 2032-09-16

Abstract

The embodiment of the utility model relates to a metal biliary tract stent, which comprises a stent body, wherein the stent body comprises a covered region covered with a covered film and a bare stent region which is not covered with the covered film, the covered region is formed in the middle section of the stent body, the bare stent region is formed at two ends of the stent body, and spiral grooves are formed on the covered film. According to the utility model, the middle section of the stent body is coated with the coating, the spiral grooves are formed in the coating, and the bare stent areas without coating are arranged at the two ends of the stent body, so that the blockage of bile duct branches, cholecyst ducts and pancreatic ducts can be effectively avoided by using the bare stent areas at the two ends and the spiral grooves formed in the coating areas, the biliary tract obstruction is opened by using the coating coated at the middle section, the tumor is prevented from growing into the biliary tract, and the occurrence of restenosis of the stent is reduced; meanwhile, the bare stent areas at the two ends have good anchoring effect, so that the displacement of the metal biliary tract stent can be effectively reduced; in addition, the spiral groove can also enhance the effect of bile drainage.

Description

Metal biliary tract stent

Technical Field

The embodiment of the utility model relates to the technical field of medical appliances, in particular to a metal biliary tract stent.

Background

Malignant biliary obstruction is a clinically common complication that occurs as a result of liver cancer, bile duct cancer, gall bladder cancer, pancreatic cancer, and invasion of other tumors on the bile duct or compression of metastatic lymph nodes in the area of bile duct travel. The biliary tract stent implantation is an effective means for treating malignant obstructive jaundice which cannot be subjected to surgery, can relieve biliary tract obstruction, alleviate jaundice symptoms, improve physical stamina of patients and create conditions for radiotherapy and chemotherapy aiming at etiology.

At present, biliary stents are usually plastic stents and metal stents, and the performance of the metal stents is superior to that of the plastic stents for malignant biliary obstruction which cannot be operated by surgery. The metal stent is divided into a bare stent and a metal biliary tract stent. The bare stent does not block bile duct branches, cholecyst ducts and pancreatic ducts, but tumors are liable to grow into the stent from the meshes of the bare stent to cause restenosis of the stent. The covered stent can overcome the defect of restenosis caused by tumor growth from naked stent meshes, but is easy to block biliary branches, cholecyst ducts and pancreatic ducts and easy to shift.

Disclosure of Invention

The embodiment of the utility model aims to provide a metal biliary tract stent so as to solve the technical problems that biliary branches, cholecyst ducts and pancreatic ducts are easy to block, tumors are easy to grow into from meshes of the stent to cause restenosis of the stent and the stent is easy to shift in the prior art.

The embodiment of the utility model provides a metal biliary tract stent, which comprises a stent body, wherein the stent body comprises a covered region covered with a covered film and a bare stent region which is not covered with the covered film, the covered region is formed in the middle section of the stent body, the bare stent region is formed at two ends of the stent body, and spiral grooves are formed on the covered film.

In some embodiments, the spiral groove is formed spirally from one end of the laminating area to the other end of the laminating area, and the spiral groove is an irregular spiral groove.

In some embodiments, the bare stent region comprises a first bare stent region and a second bare stent region at each end of the stent body, the length of the first bare stent region and the length of the second bare stent region being different.

In some embodiments, the first bare stent region has a length of 20mm to 30mm and the second bare stent region has a length of 20mm to 25mm.

In some embodiments, the surface of the covering film is coated with a drug coating, and the material of the drug coating is polymer nanometer slow-release drug particles.

In some embodiments, the polymeric nano slow release drug particles are one of paclitaxel, rapamycin, everolimus, tacrolimus.

In some embodiments, development indicator marks are arranged at two ends of the film covering area.

In some embodiments, the development indicator is made of at least one material selected from gold, platinum, and platinum iridium.

In some embodiments, the stent body has an inner diameter of 8mm to 10mm and the stent body has a length of 6cm to 10cm.

In some embodiments, the stent body is woven from nitinol wires, the stent body having a wavy mesh structure; the material of the coating is expanded polytetrafluoroethylene.

According to the metal biliary tract stent provided by the embodiment of the utility model, the middle section of the stent body is coated with the coating, the spiral groove is formed in the coating, and the bare stent areas without coating are arranged at the two ends of the stent body, so that the blockage of bile duct branches, cholecyst ducts and pancreatic ducts can be effectively avoided by using the bare stent areas at the two ends and the spiral groove formed in the coating area, and tumors are prevented from growing into biliary tract while biliary tract obstruction is opened by using the coating coated at the middle section, and the occurrence of stent restenosis is reduced; meanwhile, the bare stent areas at the two ends have good anchoring effect, so that the displacement of the metal biliary tract stent can be effectively reduced; in addition, the spiral groove can also enhance the effect of bile drainage.

Drawings

In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar components. The accompanying drawings illustrate various embodiments by way of example in general and not by way of limitation, and serve to illustrate the embodiments claimed. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive of the present apparatus or method.

FIG. 1 is a schematic diagram of a metal biliary tract stent according to an embodiment of the present utility model;

FIG. 2 is a schematic spiral view (cross-sectional view) of a spiral groove of a film-coated region according to an embodiment of the present utility model;

FIG. 3 is a schematic view showing the structure of another metal biliary tract stent according to the embodiment of the present utility model;

FIG. 4 is a schematic diagram showing the structure of a metal biliary stent implantation for treating low-level biliary obstruction according to an embodiment of the present utility model;

fig. 5 is another schematic view of a metal biliary stent implantation for treating high-level biliary obstruction according to an embodiment of the present utility model.

Reference numerals:

1-a bracket body, 11-a film covering area, the upper end of 111-a film covering area, the lower end of 112-a film covering area, 12-a bare bracket area, 121-a first bare bracket area and 122-a second bare bracket area; 2-coating; 3-spiral grooves; 4-developing the logo.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present utility model more clear, the technical solutions of the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model.

Unless otherwise defined, technical or scientific terms used in the embodiments of the present utility model should be given the ordinary meanings as understood by those having ordinary skill in the art to which the embodiments of the present utility model belong. The terms "first," "second," and the like, as used in embodiments of the present utility model, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

In order to keep the following description of the embodiments of the present utility model clear and concise, detailed descriptions of known functions and known components are omitted.

Fig. 1 to 3 are schematic structural views showing a metal biliary stent according to an embodiment of the present utility model, and fig. 4 and 5 are schematic structural views showing the implantation of the metal biliary stent for treating biliary obstruction according to an embodiment of the present utility model. As shown in fig. 1 to 5, an embodiment of the present utility model provides a metal biliary tract stent, comprising a stent body 1, the stent body 1 comprises a covered region 11 covered with a covered film 2 and a bare stent region 12 not covered with the covered film 2, the covered region 11 is formed in the middle section of the stent body 1, the bare stent region 12 is formed at both ends of the stent body 1, and a spiral groove 3 is provided on the covered film 2.

According to the metal biliary tract stent provided by the embodiment of the utility model, the coating film 2 is coated on the middle section of the stent body 1, the spiral groove 3 is formed in the coating film 2, the bare stent areas 12 which do not coat the coating film 2 are arranged at the two ends of the stent body 1, the bare stent areas 12 at the two ends and the spiral groove 3 formed in the coating film area 11 can be utilized to effectively avoid blockage of bile duct branches, gall bladder pipes and pancreas pipes, and the coating film 2 coated on the middle section is utilized to prevent tumors from growing into biliary tracts while opening biliary tract obstruction, so that the occurrence of stent restenosis is reduced; meanwhile, the bare stent areas 12 at the two ends have good anchoring effect, so that the displacement of the metal biliary tract stent can be effectively reduced; in addition, the spiral groove 3 can also enhance the effect of bile drainage.

Specifically, the bare stent region 12 includes a first bare stent region 121 and a second bare stent region 122 at both ends of the stent body 1, respectively, the first bare stent region 121 being an upper bare stent region, the second bare stent region 122 being a lower bare stent region, the lengths of the first bare stent region 121 and the second bare stent region 122 being different.

The "upper bare stent region" refers to a bare stent region near the intrahepatic bile duct, and the "lower bare stent region" refers to a bare stent region near the duodenum. In this embodiment, the lengths of the bare stent regions at the two ends are structurally designed, so that the method can be suitable for different implantation operations and treatment of different biliary tract obstruction, and the application range of the metal biliary tract stent is improved.

For example, as shown in fig. 1, when performing a PTCD operation (percutaneous liver through biliary drainage) operation, a stent is implanted percutaneously and anteriorly, i.e., the first bare stent region 121 serves as the proximal end of a metal biliary stent, and the second bare stent region 122 serves as the distal end of the metal biliary stent, and the stent is implanted by a biliary stent conveyor. The length of the biliary stent delivery device can be set smaller, for example, 40cm, when the stent implantation is performed anterogradely.

As shown in fig. 3, when the ERCP operation (endoscopic retrograde cholangiopancreatography) is performed, stent implantation is performed retrograde, i.e., the first bare stent section 121 serves as the distal end of the metal biliary stent and the second bare stent section 122 serves as the proximal end of the metal biliary stent, and the stent is implanted by the biliary stent transporter. At this time, the length of the biliary stent delivery device needs to be set long, for example, 135cm.

It should be noted that, the proximal end of the metal biliary tract stent refers to an end of the stent relatively close to the operator, and the distal end of the metal biliary tract stent refers to an end of the stent relatively far from the operator.

In the above embodiment, the length of the first bare stent area 121 and the length of the second bare stent area 122 are set to be different, and the proximal and distal designs of the metal biliary stent can be changed to adapt to different implantation procedures without setting a special stent for different types of implantation procedures.

As shown in fig. 4 and 5, the metal biliary tract stent provided by the embodiment of the utility model can be also suitable for treating different biliary tract obstruction, and as shown in fig. 4, when the metal biliary tract stent is used for treating low-level biliary tract obstruction, the second bare stent area 122 (the bare stent area at the lower end) extends out of the duodenal papilla by 5-10 mm, and the upper end 111 of the tectorial membrane area 11 is lower than the opening of the cholecyst tube. As shown in fig. 5, when the metal biliary stent is used for treating high biliary tract obstruction above the hepatic portal, the lower end 112 of the covered region 11 is higher than the opening of the cholecyst tube, and the upper end 111 of the covered region 11 exceeds the obstruction section by more than 10 mm.

In this embodiment, as shown in fig. 4 and 5, for low biliary obstruction, the second bare stent area 122 does not affect pancreatic duct, the first bare stent area 121 (upper bare stent area) does not affect biliary branches and gall bladder ducts (bile duct branches and gall bladder ducts are not blocked), and the second bare stent area 122 does not affect pancreatic ducts; for high biliary obstruction, the first bare stent region 121 does not affect intrahepatic bile duct branches and the second bare stent region 122 does not affect the cystic duct and contralateral bile duct. The metal biliary tract stent is suitable for treating different biliary tract obstruction, and can effectively avoid blockage of biliary tract branches, cholecyst ducts, pancreatic ducts and the like, and improve the stent implantation treatment effect.

In this embodiment, the lengths of the first bare stent area 121 and the second bare stent area 122 are set to be different, so that when different biliary tract obstruction is treated, the bare stent area 12 and the inner walls of the biliary tract branches, the cholecyst tube, the pancreatic duct and the like are tightly connected according to the need, and the corresponding implantation requirements are met, for example, as shown in fig. 4, the obstruction occurs below the cholecyst tube, the second bare stent area 122 partially extends into the duodenum, and the length of the second bare stent area 122 can be set to be shorter; as shown in fig. 5, the obstruction occurs above the cholecyst canal and the length of the second bare stent region 122 may be set longer to extend down below the cholecyst canal.

Preferably, the length L of the first bare stent region 121 ₁ 20mm to 30mm, the length L of the second bare stent region 122 ₂ 20mm to 25mm.

The length of the second bare stent area 122 is more preferably set to 20mm, i.e., the length of the second bare stent area 122 is fixed, and then the specific length of the second bare stent area 122 is determined according to the lesion condition.

In some embodiments, the length L of the first bare stent region 121 ₁ And a second bareLength L of the shelf region 122 ₂ The lengths of (2) may be set to be the same depending on the lesion, for example, 20mm each.

Length L of the film-covered region 11 ₃ Is 20mm to 50mm, the specific length is determined according to the pathological conditions, in particular, the length L of the tectorial membrane region 11 ₃ The length of the bare stent region 12 is larger than that of the bare stent regions at the two ends so as to effectively prevent the tumor from growing into the biliary tract and reduce the occurrence of stent restenosis.

In some embodiments, as shown in fig. 1 to 3, the spiral groove 3 is formed spirally from one end of the film covered region 11 to the other end of the film covered region 11, and the spiral groove 3 is an irregular spiral groove. The irregular spiral groove can be suitable for the different implantation operations, namely, the same bracket is adopted, different operations can be applied by changing the near end and the far end, and the application range of the bracket can be effectively improved.

The spiral groove 3 is formed spirally around the outer periphery of the film-coated region 11, and the recess depth of the spiral groove 3 is preferably 1 to 2mm, and the width is preferably 2 to 3mm.

In some embodiments, the surface of the covering film 2 is coated with a drug coating, and the material of the drug coating is polymer nanometer slow-release drug particles. Namely, the slow-release medicine is loaded on the tectorial membrane 2, and the problem of stent restenosis caused by the growth of tumors from meshes of the bare stent can be effectively solved by matching the medicine coating with the tectorial membrane 2.

The polymer nanometer slow-release drug particles are preferably one of paclitaxel, rapamycin, everolimus and tacrolimus. The material of the cover 2 is preferably low permeability expanded polytetrafluoroethylene (expended Polytetrafluoroethylene, ePTFE) to further effectively reduce stent restenosis problems.

In some embodiments, as shown in fig. 1 and 3, the two ends of the film covered region 11 are provided with developing indicia 4. The developing indicator 4 is a ring structure arranged at two ends of the film covering area 11 and is used for positioning under rays. In this embodiment, developing marks 4 are respectively disposed at two ends of the tectorial membrane area 11, so as to facilitate identification of the upper and lower ends of the tectorial membrane area 11, so as to satisfy treatment of different biliary tract obstruction. For example, it is convenient to determine whether the upper end 111 of the covered region 11 is below the opening of the cholecyst tube or whether the lower end 112 of the covered region 11 is above the opening of the cholecyst tube.

Preferably, the developing indicator 4 is made of at least one of gold, platinum iridium and other radiopaque materials.

In some embodiments, the stent body 1 is woven from nitinol wires, and the stent body 1 is in a wavy mesh structure.

Specifically, the stent body 1 is formed by continuously knitting nickel-titanium alloy monofilaments. The nickel-titanium alloy is a shape memory alloy, can automatically recover to an original shape at a certain specific temperature after deformation, has super-elastic performance, and can meet the basic requirement of a functional bracket on materials due to corrosion resistance and wear resistance. The uniformity of the knitting density of the nickel-titanium alloy monofilaments can be ensured by continuously knitting the nickel-titanium alloy monofilaments, and the integral supporting strength and the reliability of the bracket are ensured. The wavy reticular skeleton structure can effectively reduce the overall weight of the bracket.

In some embodiments, the inner diameter of the stent body 1 is preferably 8mm to 10mm, and the length of the stent body 1 is 6cm to 10cm.

Specifically, stents of different inner diameters may be selected according to the degree of stenosis of the biliary tract, and the length of the stent may be selected according to the length of the stenosis so that the entire metallic biliary tract stent may be placed into the biliary tract.

The above description is only illustrative of the preferred embodiments of the present utility model and of the principles of the technology employed. It will be appreciated by persons skilled in the art that the scope of the disclosure referred to in the present utility model is not limited to the specific combinations of technical features described above, but also covers other technical features formed by any combination of the technical features described above or their equivalents without departing from the spirit of the disclosure. Such as the above-mentioned features and the technical features disclosed in the present utility model (but not limited to) having similar functions are replaced with each other.

Claims

1. The utility model provides a metal biliary tract stent, includes the support body, its characterized in that, the support body is including the tectorial membrane district that the cladding has the tectorial membrane and the bare stent district of not cladding the tectorial membrane, the tectorial membrane district forms the interlude of support body, the bare stent district forms the both ends of support body, be equipped with spiral groove on the tectorial membrane.

2. The metal biliary tract stent of claim 1, wherein the spiral groove is formed spirally from one end of the covered region to the other end of the covered region, the spiral groove being an irregular spiral groove.

3. The metal biliary tract stent of claim 1, wherein the bare stent area comprises a first bare stent area and a second bare stent area located at each end of the stent body, the first bare stent area having a different length than the second bare stent area.

4. A metal biliary tract stent according to claim 3 wherein the length of the first bare stent area is 20mm to 30mm and the length of the second bare stent area is 20mm to 25mm.

5. The metallic biliary tract stent of claim 1, wherein the surface of the covering film is coated with a drug coating, and the drug coating is made of polymer nano slow-release drug particles.

6. The metal biliary tract stent of claim 5, wherein the polymeric nano sustained-release drug particles are one of paclitaxel, rapamycin, everolimus, tacrolimus.

7. The metallic biliary tract stent of claim 1, wherein the two ends of the covered region are provided with a development indicator.

8. The metallic biliary tract stent of claim 7, wherein the development indicator is made of at least one material selected from gold, platinum iridium.

9. A metal biliary tract stent according to any one of claims 1 to 8 wherein the stent body has an inner diameter of 8mm to 10mm and a length of 6cm to 10cm.

10. The metal biliary tract stent according to any one of claims 1 to 8, wherein the stent body is woven from nitinol wires, the stent body having a wavy mesh structure; the material of the coating is expanded polytetrafluoroethylene.