CN203524815U - Esophageal stent with full-covered membrane and taxol coating for treating benign esophagus stricture - Google Patents

Abstract

The utility model discloses an esophageal stent for treating benign esophageal stenosis fully covered with paclitaxel coating. The esophageal stent for treating benign esophageal stenosis fully covered with paclitaxel coating comprises: paclitaxel coating, filmed stent, metal wire and flexible material Membrane, strain relief ring, elastic ring, anti-reflux valve. In the utility model, the paclitaxel coating and the wire-covered stent are arranged to effectively expand the narrow part, effectively prevent the generation of collagen, and reduce the stimulation to the tissue. The utility model effectively avoids the stimulation of the metal wire to the lumen and the restenosis caused by the granulation hyperplasia at the end of the stent-graft due to the peristalsis of the lumen, and is especially suitable for the treatment of benign stenosis. In addition, the utility model has the advantages of simple structure, convenient operation and low production cost, and provides an esophageal stent with excellent performance and fully covered paclitaxel coating for treating benign esophagus stricture.

Description

A fully covered paclitaxel-coated esophageal stent for the treatment of benign esophageal strictures

technical field

The utility model belongs to the technical field of medical devices, in particular to an esophageal stent for the treatment of benign esophageal stenosis with paclitaxel coating.

Background technique

Benign esophageal stenosis is a relatively common disease, mainly including anastomotic stenosis after esophageal surgery, esophageal stenosis after radiotherapy, esophageal chemical burn stenosis, and stenosis caused by chronic esophagitis. Patients with symptoms of esophageal stenosis may be caused by benign diseases. , Malignant tumors, although the etiology is different, the results of esophageal stenosis are very painful for patients, unable to eat, drink water, as the condition worsens, it will be life-threatening, congenital esophageal diaphragm, most esophageal The cavity is blocked by a film or fibrous band, leaving only a small hole through which liquid food can pass. Clinical symptoms may not appear in infancy, but dysphagia will appear when eating thick paste or solid food. Esophageal X-ray examination shows that the esophagus The lumen is narrow, and esophagoscopy can see the lesion and make a definite diagnosis.

Immediately after the patient swallows alkaline or acidic chemicals, the esophagus is damaged, resulting in chemical burns and cicatricial stenosis of the esophagus. Taking vinegar or soda water and other anti-extractants can no longer neutralize it. Emetic drugs or gastric lavage can It should not be used to aggravate esophageal damage. Chemical burns of the esophagus often cause stenosis of the long segment of the esophagus, and most of the stomach is also involved at the same time, or even cause scar contracture, making it difficult to perform high esophagogastric anastomosis.

For benign esophageal stenosis, the traditional method is surgical treatment or mechanical expansion. The surgical treatment method is to dilate the thin film diaphragm through esophagoscopy. For those with a tough diaphragm, a thoracotomy is required to remove the narrow segment of the esophagus where the diaphragm is located. For end-to-end anastomosis of the esophagus, the disadvantages of surgical treatment: large trauma, high incidence of postoperative restenosis, great pain, high cost, and many postoperative complications. Mechanical dilatation is performed after local anesthesia of the throat. A silicone tube enters the esophagus from the oral cavity for dilation. It has the effect of dilation therapy for patients with esophageal stricture and dysphagia due to corrosion injury or post-operation. Disadvantages of mechanical dilation therapy: most patients can only relieve the stenosis in a short period of time, and patients often need repeated, Repeated or even life-long expansion treatment, stent therapy is expected to improve the curative effect. At present, fully covered stents are mainly used for treatment, but because tissue proliferation cannot be controlled, re-stenosis and stenosis at both ends of the stent can still occur. Currently, anti-tissue proliferation preparations are attached to the stent The anti-proliferation stent made on the Internet has been commercialized for the treatment of vascular stenosis, but there are few studies on anti-proliferation preparations for the treatment of esophageal stenosis, and it has not been used clinically. Paclitaxel is an anti-tumor drug commonly used in clinical practice. The dose can inhibit the proliferation and migration of smooth muscle cells, thereby inhibiting the hyperplasia of the intima and preventing restenosis after stenting. Our experimental studies have shown that placing its coating and fully covered esophageal stent on the benign esophageal stricture can significantly inhibit Tissue hyperplasia at the stenosis site to prevent restenosis.

There are the following types of stent placement: 1. Permanent placement: tissue hyperplasia at both ends of the stent after long-term placement - stenosis, hemorrhage, penetration, not recommended; Restenosis, no obvious hyperplasia at both ends of the stent, generally placed 2-4 weeks after removal, no obvious hyperplasia at both ends, but the stenosis is not completely repaired, restenosis may occur, 8-12 weeks, the stenosis repair is better, but both 3. The absorbable stent is in the development stage, but its lifespan is 6 weeks, and the repair of esophageal damage has not yet stabilized, and restenosis can still occur.

Traditional methods for the treatment of benign esophageal stenosis are traumatic and have a high incidence of postoperative restenosis, as well as great patient pain, high cost, and many postoperative complications

Utility model content

The purpose of this utility model is to provide a paclitaxel-coated esophageal stent for the treatment of benign esophageal stenosis. A problem with many complications.

The utility model is achieved in this way, an esophageal stent for treating benign esophageal stenosis fully covered with paclitaxel coating, the esophageal stent for treating esophageal benign stenosis fully covered with paclitaxel coating comprises: paclitaxel coating, stent with film, wire , flexible material membrane, tension reducing ring, elastic ring, anti-reflux valve;

The paclitaxel coating is arranged on the outermost side of the fully covered paclitaxel-coated stent, and the flexible material film is attached to the fully covered paclitaxel-coated stent through heat treatment to form a covered stent. It is connected to the end of the tension-reducing ring, the metal wire is arranged on the outside of the stent-graft, and the anti-reflux valve is installed at the lower end of the stent-graft.

Further, the anti-reflux flap is set in a petal shape to reduce reflux.

Further, the tension-relief ring connects the two ends of the stent-graft by welding.

Further, the tension reducing ring is set in a drum-shaped bell-mouth shape.

The paclitaxel-coated esophageal stent for the treatment of benign esophageal stenosis provided by the utility model adopts the paclitaxel coating and the covered stent with wires, and keeps the stenosis for about one month, so that the stenosis can be effectively expanded, and the stenosis can be effectively expanded. Drugs can effectively prevent the formation of collagen, so that the dilated stenosis will not form stenosis again. At the same time, due to the short placement time, the stimulation of the two ends of the stent to the tissue is relatively light, and the effect of anti-proliferation drugs will not cause stenosis at both ends of the stent . The utility model adopts the connection of the tension-reducing ring at the end of the stent with film, and the tension-reducing ring effectively avoids the stimulation of the metal wire to the lumen, and avoids the granulation hyperplasia at the end of the stent with film due to the peristalsis of the lumen. Stenosis, especially suitable for the treatment of benign stenosis. In addition, the utility model has the advantages of simple structure, convenient operation and low manufacturing cost, and provides an esophageal stent with excellent performance and fully covered paclitaxel coating for treating benign esophagus stricture.

Description of drawings

Fig. 1 is a schematic structural view of the paclitaxel-coated esophageal stent for the treatment of benign esophagus stenosis provided by the embodiment of the present invention;

In the figure: 1, stent with membrane; 1-1, metal wire; 1-2, flexible material membrane; 2, tension-relieving ring; 2-1, elastic ring; 3, anti-reflux valve; 4, paclitaxel coating.

Detailed ways

In order to make the purpose, technical solution and advantages of the utility model clearer, the utility model will be further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described here are only used to explain the utility model, and are not intended to limit the utility model.

Fig. 1 shows the structure of the fully-covered paclitaxel-coated esophageal stent for the treatment of benign esophagus stricture provided by the embodiment of the present invention. For ease of description, only the parts relevant to the present utility model are shown.

The fully covered paclitaxel-coated esophageal stent for treating benign esophageal stenosis according to the embodiment of the utility model, the esophageal stent for treating benign esophageal stenosis fully covered with paclitaxel coating includes: paclitaxel coating, filmed stent, metal wire, flexible material film , tension reducing ring, elastic ring, anti-reflux valve;

The paclitaxel coating is set on the outermost side of the fully covered paclitaxel-coated stent, and the flexible material film is attached to the fully covered paclitaxel-coated stent through heat treatment to form a covered stent. The tension-reducing ring is connected to both ends of the covered stent. It is connected to the end of the tension-reducing ring, the metal wire is arranged on the outside of the stent-graft, and the anti-reflux valve is installed at the lower end of the stent-graft.

As an optimized solution of the embodiment of the present utility model, the anti-reflux flap is set in a petal shape to reduce backflow.

As an optimized solution of the embodiment of the present invention, the tension-reducing ring connects the two ends of the stent-graft by welding.

As an optimization scheme of the embodiment of the utility model, the tension reducing ring is set in a drum-shaped bell-mouth shape.

The preparation method of the utility model is as follows: construct the fully-covered stent first, then soak the fully-covered esophageal stent in the paclitaxel suspension, coat the paclitaxel on the surface of the esophageal stent, and then place the esophageal stent in a 60°C vacuum oven Made in 8h of medium treatment.

As an optimization scheme of the embodiment of the present invention, the stent with film is formed by weaving metal wires of nickel-titanium memory alloy into a grid shape on the mold, performing heat treatment for shaping, and covering the mold with a flexible material film.

The application principle of the present utility model will be further described below in conjunction with the accompanying drawings and specific embodiments.

As shown in Figure 1, the esophageal stent for the treatment of benign esophageal stenosis fully coated with paclitaxel coating in the embodiment of the utility model is mainly composed of a stent with film 1, a metal wire 1-1, a flexible material film 1-2, a tension reducing ring 2, Composed of elastic ring 2-1, anti-reflux valve 3, and paclitaxel coating 4; paclitaxel coating 4 is set on the outermost side of the fully covered paclitaxel-coated stent, and paclitaxel coating 4 is obtained by soaking the esophageal stent in paclitaxel suspension , coating paclitaxel 4 on the surface of the esophageal stent, and then placing the esophageal stent in a vacuum oven at 60°C for 8 hours. The covered stent 1 is used as the backbone of the recyclable fully covered paclitaxel coating, which can effectively dilate the stenosis; The flexible material film 1-2 is attached to the support by heat treatment to form a support with film 1, the drum-shaped tension-reducing ring 2 is connected to the upper end of the support with film 1 through special welding, and the bell-shaped tension-reducing ring 2 is connected to the support through special welding. The lower end of the stent with membrane 1, thus effectively avoiding the stimulation of the lumen by the metal wire 1-1, the elastic ring 2-1 is connected to the end of the tension-reducing ring 2 by special welding, which can effectively tighten the tension-reducing ring 2 Fitting on the lumen of the esophagus to prevent the collapse of the tension reducing ring 2; the metal wire 1-1 is wound around the outer end of the stent-graft 1 through deformation to form a grid, thereby supporting the stent-graft 1 and preventing reflux valve 3 Installed in the bell-shaped tension reducing ring 2 at the lower end of the edge of the lower end of the stent with film 1, so as to reduce backflow, the stent with film 1 is woven into a grid shape on the mould, using nickel-titanium memory alloy through a flexible material film, and Carry out heat treatment for shaping to obtain a bare grid support, and then cover it with a flexible material in a mold to obtain a film-covered support 1. The flexible material 1-2 can be a soft, properly elastic polymer material or polymer, Such as medical silicone, medical polyurethane, medical polytetrafluoroethylene, medical polypropylene, etc., the tension reducing ring 2 adopts a drum shape at the upper end of the film support 1, and a bell mouth shape at the lower end of the film support 1, and both are made of flexible materials. , the elastic ring on the tension reducing ring 2 is made of a relatively thick flexible material, the elastic ring 2-1 can effectively fit the tension reducing ring 2 on the inner wall of the esophagus, and prevent the tension reducing ring 2 from collapsing. 1-1 Medical nickel-titanium shape memory alloy wires are usually used on the stent-graft 1 , and the anti-reflux valve 3 is petal-shaped, and can reduce reflux.

Working principle of the utility model:

The paclitaxel coating 4 of the utility model is made by soaking the esophageal stent in the paclitaxel suspension, applying the paclitaxel coating 4 on the surface of the esophageal stent, and then placing the esophageal stent in a vacuum oven at 60°C for 8 hours. The upper end of the tension-reducing ring 2 is connected with a tension-reducing ring 2. The tension-reducing ring 2 adopts a bell mouth-shaped tubular structure made of a flexible material. The flexible material can be soft, properly elastic polymer materials and polymer materials, such as medical silicone, medical polyurethane, Made of medical polytetrafluoroethylene, medical polypropylene, etc., there is an elastic ring 2-1 made of a relatively thick flexible material at the uppermost end of the tension-reducing ring 2, and the elastic ring 2-1 can effectively fit the tension-reducing ring 2 on the On the inner wall of the esophagus, to prevent the collapse of the tension-reducing ring 2, in clinical use, after the stent is implanted into the benign stenosis of the esophagus, the stent-graft 1 can effectively expand the stenosis, and the tension-reducing ring 2 is above the normal stenosis In the lumen, and attached to the inner wall of the lumen, the tension-reducing ring 2 made of flexible materials can effectively disperse the stress concentration formed by the metal wire 1-1 of the stent-graft 1, and the tension-reducing ring 2 can control the peristalsis of the esophagus Exercise reduces the stimulation of the metal wire 1-1 to the esophageal mucosa and avoids the growth of granulation. After several months of implantation in the body, when the scar tissue is stable, it can be taken out of the body. Usually, the metal wire 1 of the stent with membrane 1 -1 uses medical nickel-titanium shape memory alloy, flexible material film 1-2 is made of medical silicone or medical polyurethane, first uses nickel-titanium memory alloy to weave into a grid shape on the mold, and performs heat treatment to obtain a bare grid support , and then covered with a flexible material in the mold to obtain a recyclable full-covered paclitaxel-coated esophageal metal stent.

The above descriptions are only preferred embodiments of the present utility model, and are not intended to limit the present utility model. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present utility model shall be included in this utility model. within the scope of protection of utility models.

Claims (4)

1. an Esophageal Stent for the treatment of the full overlay film paclitaxel of Benign esophageal stenosis coating, it is characterized in that, the Esophageal Stent of the full overlay film paclitaxel of this treatment Benign esophageal stenosis coating comprises: paclitaxel coating, covered stnet, tinsel, flexible material film, subtract Zhang Huan, elastic ring, the anti-lobe that backflows;

Paclitaxel coating is arranged on the outermost of full overlay film Paclitaxel eluting stent, flexible material film is attached on full overlay film Paclitaxel eluting stent and is formed covered stnet by heat treatment, subtract the two ends that Zhang Huan is connected to covered stnet, elastic ring is connected to the end that subtracts Zhang Huan, tinsel is arranged on the outside of covered stnet, and the anti-lobe that backflows is arranged on covered stnet lower end.

2. the Esophageal Stent of the full overlay film paclitaxel for the treatment of Benign esophageal stenosis as claimed in claim 1 coating, is characterized in that, the anti-lobe that backflows is set to reduce the petal-shaped of adverse current.

3. the Esophageal Stent of the full overlay film paclitaxel for the treatment of Benign esophageal stenosis as claimed in claim 1 coating, is characterized in that, subtracts Zhang Huan by being welded to connect the two ends of covered stnet.

4. the Esophageal Stent of the full overlay film paclitaxel for the treatment of Benign esophageal stenosis as claimed in claim 1 coating, is characterized in that, subtracts Zhang Huan and is set to drum type broadening formation.

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