阅读说明：本技术 一种儿童专用型可回收全覆膜载药食管支架及其制作方法 (Recyclable full-coated drug-loaded esophageal stent special for children and manufacturing method thereof ) 是由 莫绪明 于 2021-01-29 设计创作，主要内容包括：本专利公开了一种儿童专用型可回收全覆膜载药食管支架,包括鼻腔部分,食管支架由单根直径0.22mm的镍钛合金丝编织成菱形网状支架,中部呈圆柱状,两端膨大呈筒状,食管支架外壁附有全覆膜,全覆膜表面带有药物附载层,主要用于儿童良性食道狭窄的扩张治疗；本专利通过带线覆膜支架和设置缓释载药涂层,使狭窄部位得到有效扩张,同时有效阻止胶原的生成,减轻了对组织的剌激、延缓瘢痕形成,能有效避免金属丝对腔管的剌激和因腔管的蠕动导致带膜支架端部的肉芽增生形成的再狭窄,特别适合于儿童良性狭窄的治疗,本发明结构简单,操作方便,制作成本低。(The patent discloses a recoverable full-coated drug-loaded esophageal stent special for children, which comprises a nasal cavity part, wherein the esophageal stent is a rhombic net stent woven by nickel-titanium alloy wires with the diameter of 0.22mm, the middle part of the esophageal stent is cylindrical, the two ends of the esophageal stent are expanded to be cylindrical, a full coating is attached to the outer wall of the esophageal stent, and the surface of the full coating is provided with a drug-loaded layer which is mainly used for the dilation treatment of benign esophageal stenosis of children; the invention effectively expands the narrow part by the covered stent with the line and the slow-release drug-carrying coating, simultaneously effectively prevents the generation of collagen, lightens the stimulation to the tissues, delays the scar formation, can effectively avoid the stimulation of a metal wire to a cavity tube and the restenosis formed by the granulation hyperplasia at the end part of the covered stent due to the peristalsis of the cavity tube, and is particularly suitable for the treatment of benign stenosis of children.)

1. The utility model provides a recoverable full tectorial membrane medicine carrying esophagus support of children special type, includes the nasal cavity part, its characterized in that: the esophageal stent is a rhombic net stent woven by nickel-titanium alloy wires with the diameter of 0.22mm, the middle part of the esophageal stent is cylindrical, the two ends of the esophageal stent are expanded to be cylindrical, the outer wall of the esophageal stent is attached with a full-coating film, and the surface of the full-coating film is provided with a medicine carrying layer.

2. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 1, wherein: the diameter of the esophageal stent is 6mm-18 mm; the length of the esophageal stent is 20mm-100 mm.

3. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 1, wherein: the full-covering film is prepared from expanded polytetrafluoroethylene.

4. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 1, wherein: the drug carrying layer is composed of a plurality of polycaprolactone nano microspheres.

5. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 4, wherein: the medicine contained in the polycaprolactone nano-microsphere is any one of glucocorticoid, mitomycin, paclitaxel derivative, actinomycin D, 5-fluorouracil oh Wan and rapamycin.

6. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 1, wherein: the nasal cavity is externally sleeved with a latex tube.

7. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 6, wherein: the latex tube is made of polyisoprene material.

8. The recyclable full-covered drug-loaded esophageal stent special for children according to claim 7, wherein: the latex tube has an outer diameter of 2 mm.

9. The recyclable full-covered drug-loaded esophageal stent special for children according to claims 1-8, wherein the esophageal stent is placed by the following method: the near end of the esophageal stent is threaded with a traction wire as a recovery wire, the wire is sequentially threaded into a nickel-titanium alloy wire inflection part at intervals along the near end of the stent, after one circle of the wire is threaded, a first circle of the wire is sequentially threaded along the inner wall of the near end of the stent, after a second circle of the wire is continuously threaded, the ends and the tails of the recovery wire are converged, the recovery wire is tied after being tightened, the recovery wire is threaded into a regular hexagon star shape in the cavity of the near end of the stent, and the tail end of the recovery wire penetrates through a latex tube sleeved outside a nasal.

10. A method for manufacturing a recyclable full-coated drug-loaded esophageal stent special for children according to claims 1-8, comprising the following steps:

1) the upper and middle digestive tract radiography examination shows that the narrow part, the narrow degree and the narrow length are clear:

2) obtaining the length and the diameter of the stent to be placed according to the data;

3) processing a mould, weaving and shaping, installing a metal pillar after the mechanical processing of the mould is completed, starting to wind the support on the mould, performing heat treatment and shaping after the winding is completed, arranging a traction wire at the near end of the support, and laminating a film.

Technical Field

The invention relates to a prosthesis in the technical field of medical engineering and a manufacturing method thereof, in particular to a recyclable full-covered drug-loaded esophageal stent special for children and a manufacturing method thereof.

Background

Esophageal stenosis in children is a not uncommon disease, and mainly comprises anastomotic stoma stenosis after neonatal esophageal atresia, stenosis after chemical esophageal burn, stenosis caused by gastroesophageal reflux and the like, and stenosis after a few esophageal radiotherapy. The esophageal stenosis in children is a benign disease. The esophageal stenosis causes serious obstacles to the growth and development of the infant patient, and sometimes endangers life as the condition progresses.

Children cause congenital esophageal stenosis or congenital esophageal stenosis, and the infant may not present clinical symptoms and present dysphagia when starting to eat fluid or thick paste food. Secondly, chemical burn and scar stenosis of the esophagus caused by the children patients swallowing alkaline or acidic chemicals by mistake; chemical burns of the esophagus often cause a long-section stricture of the esophagus, and the stomach is mostly affected at the same time, or even cause epilepsy and contracture.

The current methods for treating esophageal stenosis are few, and the traditional method is surgery or mechanical dilation. The operation treatment is a method of cutting a chest incision or thoracoscopy, a narrow section of esophagus at the position of a diaphragm is cut off, and then the opposite-end anastomosis of the esophagus is performed, the colon or stomach is mostly adopted for long section of esophagus stenosis caused by chemical burn of the esophagus, but the high-position esophagogastric anastomosis is difficult to perform if the stomach is affected by burn, and the operation has the defects of large wound, high cost, more postoperative complications and high restenosis occurrence rate. The mechanical dilation treatment is to perform local anesthesia on throat and then to gradually dilate the dilation tube from the oral cavity to the narrow part of the esophagus, and has certain effect on the sick children with erosive scar stenosis or postoperative narrow esophagus.

The esophageal stent treatment technology is a supplementary means for treating children patients with poor dilatation treatment effect, which is derived along with the development of material science and technology in recent years. The internal support for treating malignant esophageal stenosis is widely applied to adults, but no commercial product special for children exists until now.

In adults, the placement of metallic stents in malignant stenosis is a palliative treatment, and the stents do not need to be taken out. For benign stenosis, such as tracheomalacia, scar stenosis, etc., due to the long-term retention of the stent, physicochemical irritation may be produced to cause inflammatory reaction, edema and hyperplasia of local mucosa, and in order to prevent the occurrence of complications at the middle and long periods, the stent must be removed after the stent has been subjected to supporting and expanding action for a certain period of time. The existing recoverable alloy stent for adults clinically reported can be embedded into mucosa after being placed into a human body for a certain time because the stent has no capsule; the circumference of the recovery line of the upper opening of the stent is consistent with that of the upper opening of the stent, the recovery line is tightly attached to the upper opening, the upper opening of the stent and the recovery line are embedded into mucosa due to mucosa hyperplasia or inflammatory edema after the stent is placed for a certain time, meanwhile, local mucosa generates inflammatory reaction due to stimulation of the stent, mucosa edema and hyperplasia appear, restenosis is formed by the fact that the stent grows into the cavity of the stent from meshes of the stent, and the stent is embedded into tissues and is very difficult to take out.

Children are not the shrinking versions of adults, and the supports are not commercialized so far because the children have growth and development requirements and other specificities, the generation reason, the evolution result and the treatment target of the esophageal stenosis are greatly different from those of the adults, the children have large age span, the esophageal support has more size models than the adults and the quality requirement is higher. In order to effectively treat the esophageal stenosis of children, the invention of the esophageal stenosis support special for children is urgently needed.

The children esophageal stenosis support has more urgent requirements on controlling tissue proliferation, preventing esophageal restenosis and the stenosis at two ends of the support. At present, anti-tissue proliferation preparations are attached to a stent to prepare an anti-proliferation stent for treating vascular stenosis, and the anti-proliferation stent is commercialized and used clinically, but the research on treating esophageal stenosis by using the anti-proliferation preparations is in the preclinical stage, and the research on exploring one or more mixed doses to inhibit the proliferation of cells so as to inhibit the excessive hyperplasia of intima and prevent restenosis after stent operation is a development trend. The experimental research shows that the commercialized drug coating partially used for treating the vascular stenosis is used for a full-coated esophageal stent and is arranged at the benign stenosis position of the esophagus, so that the tissue hyperplasia of the stenosis position can be obviously inhibited, and the occurrence of restenosis is reduced.

Disclosure of Invention

The invention provides a recyclable full-coated medicine-carrying esophageal stent special for children and a manufacturing method thereof, aiming at the defects in the prior art and solving the problems in the prior art.

The invention uses the covered stent with line and the slow release drug-carrying coating layer formed by a plurality of polycaprolactone nano microspheres, the stent effectively expands the narrow part, the covered drug-carrying coating layer effectively prevents the generation of collagen, lightens the stimulation to the tissue, delays the scar formation, can effectively avoid the stimulation to the lumen tube by the metal wire and the restenosis formed by the granulation hyperplasia at the end part of the covered stent due to the peristalsis of the lumen tube, and is particularly suitable for the treatment of benign stenosis of children.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

a recoverable full-coated medicine-carrying esophageal stent special for children comprises a nasal cavity part, wherein the esophageal stent is a rhombic net stent woven by nickel-titanium alloy wires with the diameter of 0.22mm, the middle part of the esophageal stent is cylindrical, two ends of the esophageal stent are expanded to be cylindrical, a full coating is attached to the outer wall of the esophageal stent, and a medicine carrying layer is arranged on the surface of the full coating.

Furthermore, the diameter of the esophageal stent is 6mm-18 mm; the length of the esophageal stent is 20mm-100 mm.

Further, the full-coating film is prepared from expanded polytetrafluoroethylene.

Furthermore, the drug carrying layer is composed of a plurality of polycaprolactone nano microspheres.

Furthermore, the medicine contained in the polycaprolactone nano-microspheres is any one of glucocorticoid, mitomycin, paclitaxel derivative, actinomycin D, 5-fluorouracil oh Wan and rapamycin.

Furthermore, a latex tube is sleeved outside the nasal cavity.

Further, the latex tube is made of polyisoprene materials.

Further, the outer diameter of the latex tube is 2 mm.

The method for implanting the esophageal stent comprises the following steps: the near end of the esophageal stent is threaded with a traction wire as a recovery wire, the wire is sequentially threaded into a nickel-titanium alloy wire inflection part at intervals along the near end of the stent, after one circle of the wire is threaded, a first circle of the wire is sequentially threaded along the inner wall of the near end of the stent, after a second circle of the wire is continuously threaded, the ends and the tails of the recovery wire are converged, the recovery wire is tied after being tightened, the recovery wire is threaded into a regular hexagon star shape in the cavity of the near end of the stent, and the tail end of the recovery wire penetrates through a latex tube sleeved outside a nasal.

A method for manufacturing a recyclable full-film drug-loaded intraesophageal stent special for children comprises the following steps:

1) the upper and middle digestive tract radiography examination shows that the narrow part, the narrow degree and the narrow length are clear:

2) obtaining the length and the diameter of the stent to be placed according to the data;

3) processing a mould, weaving and shaping, installing a metal pillar after the mechanical processing of the mould is completed, starting to wind the support on the mould, performing heat treatment and shaping after the winding is completed, arranging a traction wire at the near end of the support, and laminating a film.

Compared with the prior art, the invention has the following beneficial effects because the technology is adopted:

1. the stent is woven by nickel-titanium alloy wires with the diameter of 0.22mm, has good shape memory, can achieve the maximum expansion force under the body temperature state by adjusting the phase transition temperature, is beneficial to the expansion of stenosis, has good compliance and can be tightly contacted with the tube wall;

2. the invention designs models with different diameters and lengths, and is suitable for children of various ages; the special recyclable esophageal stent is designed by combining the pathological change characteristics of children, so that the requirement of children in the growth and development period is met;

3. the invention adopts the traction wire with enough strength penetrated at the near end of the esophageal stent as the recovery wire, thereby not only fixing the stent, but also effectively preventing the stent from sliding;

4. the covered stent can prevent the nickel-titanium alloy wires from being embedded into tissues and the tissues from growing into the stent cavity;

5. the outer wall of the esophageal stent adopts full-covering film drug loading, so that the tissue hyperplasia of a narrow part can be obviously inhibited, and the restenosis is reduced, thereby having important significance for benign stricture of the esophagus.

Drawings

FIG. 1 is a schematic structural view of a recyclable full-coated drug-loaded esophageal stent dedicated for children;

FIG. 2 is a side view of a child-specific type of recyclable full-coated drug-loaded esophageal stent;

in the figure: 1. esophageal stent, 2, full film, 3, recovery wire, 4 and drug carrying layer.

Detailed Description

The invention is further elucidated with reference to the drawings and the detailed description.

Example 1:

the utility model provides a recoverable full tectorial membrane medicine carrying esophagus support of children's special type, includes the nasal cavity part, esophagus support 1 is woven into rhombus network support by single diameter 0.22 mm's nickel titanium alloy silk, and the middle part is cylindricly, and both ends expand and be the tube-shape, and 1 outer wall of esophagus support is with full tectorial membrane 2, and 2 surfaces of full tectorial membrane have medicine to carry layer 4.

The diameter of the esophageal stent 1 is 6mm-18 mm; the length of the esophageal stent 1 is 20mm-100 mm.

The full-coating film 2 is prepared from expanded polytetrafluoroethylene.

The drug carrying layer 4 is composed of a plurality of polycaprolactone nano microspheres. The medicine contained in the polycaprolactone nano-microsphere is any one of glucocorticoid, mitomycin, paclitaxel derivative, actinomycin D, 5-fluorouracil oh Wan and rapamycin.

Example 2:

a recyclable full-coated medicine carrying esophageal stent special for children comprises a nasal cavity part, wherein a latex tube is sleeved outside the nasal cavity part and is made of polyisoprene materials, and the outer diameter of the latex tube is 2 mm.

The far end of the esophageal stent 1 is not provided with a traction wire structure, and the traction wire at the near end of the esophageal stent 1 can be guided to pass through the latex tube through a guide wire.

The method for implanting the esophageal stent 1 comprises the following steps:

the near end of the esophageal stent 1 is threaded with a traction wire as a recovery wire 3, the wire firstly penetrates through a nickel-titanium alloy wire back-folding position in sequence along the interval of the near end of the stent, after one circle of the wire is threaded, a first circle of the wire is threaded in sequence along the inner wall of the near end of the stent, after a second circle of the wire is continuously threaded, the 3 ends and the tails of the recovery wire converge, the recovery wire 3 is tied in a knot after being tightened, the recovery wire 3 is threaded into a regular hexagon in the cavity of the near end of the stent, and the tail end of the recovery wire 3 penetrates through a.

Example 3:

a method for manufacturing a recyclable full-film drug-loaded intraesophageal stent special for children comprises the following steps:

1) the upper and middle digestive tract radiography examination shows that the narrow part, the narrow degree and the narrow length are clear:

2) obtaining the length and the diameter of the stent to be placed according to the data;

3) processing a mould, weaving and shaping, installing a metal pillar after the mechanical processing of the mould is completed, starting to wind the support on the mould, performing heat treatment and shaping after the winding is completed, arranging a traction wire at the near end of the support, and laminating a film.

The above-mentioned embodiments are merely preferred embodiments of the present invention, and should not be construed as limiting the present invention, and the scope of the present invention should be defined by the claims, and equivalents including technical features of the claims, i.e., equivalent modifications within the scope of the present invention.