CN104434354B - Stent placement device - Google Patents

Abstract

The invention discloses a stent inserter, which comprises an outer tube for placing a stent, a head structure is provided at the far end of the outer tube, and a wire core and a middle tube fixedly connected with the head structure are arranged inside the outer tube; When the stent is released, the head structure, wire core and middle tube remain in a fixed position, the outer tube is withdrawn, the stent is released, and then the head structure, wire core and middle tube are withdrawn. Many disadvantages of the traditional stent implanter to release the stent are avoided, the operation risk is reduced, the operation difficulty is reduced and a large amount of operation time is saved.

Description

A stent inserter

technical field

The invention relates to a medical device, in particular to a miniaturized bracket inserter capable of conveniently inserting brackets into human organs.

Background technique

The structure of the existing stent implanter is complicated, including inner tube, outer tube, middle tube, soft head and other structures, and it is necessary to ensure that the inner diameter of the inner tube can pass through a zebra guide wire with a diameter of 0.035” (0.889mm), so that the inner tube diameter is larger , causing the gap between the inner tube and the outer tube to decrease, thereby reducing the space for placing the stent, and the designer has to increase the outer diameter of the outer tube to achieve the purpose of loading the stent. This cannot be applied to many narrow, long and curved tissues in the human body. .

For example, the implantation of tracheal stents is used to treat malignant diseases such as lung cancer and benign diseases such as tuberculosis and other narrowing of the trachea and bronchial lumen, which have been affirmed by the medical community, but the release steps of the stents are cumbersome and require technical requirements for medical personnel. High, the risk to the patient is high.

Traditional tracheal stent implantation methods include the following:

1. Placement under direct vision of the bronchoscope: Guided by the bronchoscope to insert the guide wire, retract the mirror, insert the bronchoscope again through another nasal cavity or oral cavity, insert the inserter equipped with the stent into the airway along the guide wire, and release the stent at the narrow part . Its advantage is that the stent is released under direct vision of the bronchoscope, and if the release is not in place, it can be found and adjusted in time. Its disadvantage is that the inserter and the bronchoscope enter the airway at the same time, which has a great impact on ventilation and increases the risk of operation. In addition, when operating under general anesthesia, the endotracheal tube and ventilator need to be disconnected for a short time to facilitate the release of the stent. Losing the protection of the ventilator during the placement of the stent will be very dangerous for patients with dyspnea and general anesthesia, and it will also be a great challenge to the surgeon, increasing the surgical pressure.

2. Insertion under the guidance of X-ray fluoroscopy: first insert the bronchoscope into the airway, under X-ray fluoroscopy, use a paper clip to locate the body surface at the upper and lower edges of the stent to be placed, insert the guide wire through the biopsy hole, and exit the bronchoscope. The inserter equipped with the stent is inserted into the airway along the guide wire, and the stent is pushed to the narrow part of the airway under the guidance of X-ray fluoroscopy, and the stent is released after the positioning is accurate. Its disadvantages are cumbersome steps, no accurate and reliable positioning under bronchoscope direct vision, medical staff and patients are exposed to radiation and other shortcomings.

3. Insertion directly under the guidance of the bronchoscope in the past: the double-layer plastic tube with the stent is placed on the bronchoscope or the stent is directly tied to the bronchoscope, and the stent is released when the bronchoscope is inserted through the stenosis. This method has poor flexibility of bronchoscope, poor placement accuracy, and is easy to damage the bronchoscope, so it is rarely used clinically. References "Bronchoscopic Interventional Therapy"

The reason why the above traditional bronchial stent placement method adopts blind placement and release under X-ray fluoroscopy is mainly because the maximum forceps channel of the electronic bronchoscope is only φ2.8mm, while the outer diameter of the traditional bronchial stent implanter is usually 9Fr (φ3mm) , 10Fr(φ3.3mm), 11Fr(φ3.65mm), 12Fr(φ4mm), so the inserter cannot enter the pathological position through the forceps hole.

As another example, various malignant tumors of the digestive tract can cause severe obstruction due to direct infiltration or compression of the tumor in the late course of the disease. According to statistics, 40% of patients with gastric cancer and 95% of patients with pancreas involving the duodenum cannot undergo radical surgery . At this time, it is wise to choose endoscopic stent placement. Currently, the commonly used stenosis sites are:

1) Stenosis caused by malignant esophageal tumor;

2) Stomach, duodenal descending part, pancreaticobiliary tumors and gastric cancer with anastomotic stenosis;

3) Colon malignant tumor obstruction and anastomotic stricture after colon surgery.

At present, the traditional release method of the stent is: firstly, the endoscope reaches the pathological stenosis. If the endoscope cannot pass through the stenosis, a zebra guide wire is first passed through the stenosis, and a plastic sleeve is inserted along the guide wire, and a contrast agent is injected. Determine the location of the distal lesion under X-ray, measure the length of the entire lesion, and determine the length of the required stent again (2cm above and below the lesion), and then insert the TTS device through the endoscope along the guide wire to reach the stenosis. Then perform the stent release.

Contents of the invention

Purpose of the invention: The technical problem to be solved by the present invention is to provide a stent inserter for the deficiencies of the prior art.

In order to solve the above technical problems, the present invention discloses a stent inserter, which includes an outer tube for placing the stent, a head structure is provided at the far end of the outer tube, and a wire core fixedly connected to the head structure is arranged inside the outer tube and middle management;

When the stent needs to be released, the head structure, wire core and middle tube remain in a fixed position, the outer tube is withdrawn, the stent is released, and then the head structure, wire core and middle tube are withdrawn.

In one solution of the present invention, the head structure is a hard structure.

In the second solution of the present invention, the head structure is a soft structure, so that the inserter has a guiding function.

In the present invention, the end of the head structure away from the outer tube is provided with a slender and developable extension hose, the core passes through the center of the extension hose, and the end of the wire core is located in the extension hose. The inserter does not have a plastic inner tube, but instead has a thinner solid wire core.

For example, black marks are printed on the outer tube at a position corresponding to the proximal end of the stent and a position 10 mm away from the proximal end of the stent.

Description of drawings

The advantages of the above and/or other aspects of the present invention will become clearer as the present invention will be further described in detail in conjunction with the accompanying drawings and specific embodiments.

Fig. 1 is the structural schematic diagram of embodiment 1.

Fig. 2 is a schematic structural diagram of embodiment 2.

detailed description

Example 1

As shown in Figure 1, the present invention discloses a tracheal stent implanter, comprising an outer tube 1 for placing the stent 6, the distal end of the outer tube 1 is provided with a head structure 3, and the outer tube is provided with a head structure Fixedly connected wire core 2 and middle tube 4.

This embodiment simplifies the steps during the release of the stent and reduces the complications during the release of the stent. The traditional inner tube of the inserter is canceled, and the φ0.58mm nickel-titanium wire is used as the wire core 2, thereby saving the space of φ0.7mm, which is equivalent to the space of 2Fr. This provides the possibility to put the existing tracheal stent into the 8Fr (φ2.65mm) inserter, which also makes it possible to insert the new tracheal stent inserter (8Fr) into the bronchoscope clamp channel (φ2.8mm). possible.

The head structure 3 of the inserter adopts a metal bullet type or a spherical shape, so that the inserter can pass through the narrow section better. The surface of the outer tube 1 of the inserter is treated with clear water coating to make the outer tube more lubricated and easier to pass through the narrow section of the clamp channel. At the transparent section of the front end of the outer tube, black MARKs are printed on the proximal end of the stent and the position 10mm from the proximal end respectively. When the doctor releases the stent 6, after seeing the second MARK, withdraw the outer tube 1, and the first The MARK is aimed at the proximal end of the stenosis, and the middle tube 4 is pushed to start releasing the stent. After the release, the proximal end of the stent coincides with the proximal end of the stenosis. If necessary, the biopsy forceps can be used to pull the stent back a little for final precise positioning confirmation.

The 8Fr tracheal stent implanter can insert the traditional nickel-titanium wire braided tracheal stent into the pathological position of the trachea through the electronic bronchoscope forceps, and release the stent accurately under the direct vision of the bronchoscope. At the same time, it can ensure the use of endotracheal intubation, so that the operation can always be carried out under the protection of the ventilator, avoiding many shortcomings of traditional tracheal stent release, reducing the risk of operation, reducing the difficulty of operation and saving a lot of operation time.

Example 2

This embodiment provides a TTS esophageal and intestinal stent implanter. In this embodiment, 1 is an outer tube, 2 is a nickel-titanium wire with a taper of 0.58 mm at the front end as a wire core, 3 is a soft head structure, and 5 is a flexible head. Developing PU extended soft head, 4 is the middle tube, 6 is the bracket. The soft head structure 3 and the extended soft head 5 are connected to the wire core 2 through UV glue. After the bracket is compressed, the left and right are the middle tube 4 and the head structure 3, and the inside and outside are between the outer tube 1 and the wire core 2, and the space between the outer tube 1 and the wire core 2 saves 2Fr. When releasing, the lengthened soft head 5 first crosses the stenosis to guide the head structure 3, and the outer tube 1 passes through the stenosis in sequence. When the second MARK outside the outer tube 1 is seen through the endoscope, confirm that the second MARK is consistent with the stenosis. The proximal end of the end overlaps, and the outer tube 1 is retracted at a uniform speed. The stent is slowly opened and released under the push of the middle tube 4. One piece does not move.

The traditional inner tube of the inserter is canceled, and a φ0.58mm nickel-titanium wire is used as the core 2, thereby saving the space of φ0.7mm, which is equivalent to the space of 2Fr. This means that when releasing stents of the same specification, the outer diameter of the inserter can be made smaller (theoretically, it can be 1-2 Fr smaller), which will play an inestimable role in the development of endoscopic therapy. For example: the esophageal stent is usually released by OTW method, and the outer diameter is greater than 6mm; if it is released by the TTS method (through the endoscopic lumen φ3.8mm), the outer diameter of the inserter cannot be greater than 10.5Fr, and the design space of the traditional inserter is very small. Small, stents can only be loaded into conventional inserters with reduced radial support force. The new inserter has increased the space of 2Fr due to the cancellation of the inner tube, so that the stent can be loaded into the new inserter without losing the radial support force, so as to promote the precise release of the stent under the endoscope and avoid the OTW release belt A lot of bad things came. At the same time, the unique design of the front end of the inserter installs the soft PU tube that can be seen under X-rays on the guide wire after the front taper is ground, so that the front end of the inserter is soft without losing its toughness, and can be smoothly inserted. Through the narrow segment without injuring the tissue, it has the same function as the guide wire. Thereby reducing the operation difficulty and saving a lot of operation time, and also canceling the guide wire for some operations, providing the possibility for patients to save money, and has a good market prospect.

The inner tube of the traditional inserter is canceled and replaced by nickel-titanium wire, which saves 2Fr space. The unique design of the front end of the inserter installs the soft PU tube that can be seen under X-ray on the guide wire after the front taper grinding , so that the front end of the inserter is soft without losing tenacity, that is, it can pass through the narrow section smoothly without hurting the tissue, which is equivalent to the function of the guide wire, so that the inserter can pass through the narrow section better, and at the same time, the front end PU, can be visualized under X-ray, and the inserter and bracket can be accurately found under X-ray. The surface of the outer tube of the inserter and the front guide are treated with clear water coating, which makes the appearance of the inserter more lubricated and easier to pass through the clamp channel and narrow section.

The outer tube accurately marks the release position of the stent: at the transparent section of the front end of the outer tube, black MARKs are printed on the proximal end of the stent and 10mm from the proximal end respectively. When the doctor releases the stent, after seeing the second MARK, he will place a The device is retracted, the first MARK is aligned with the proximal end of the stenosis, and the stent is released. After the release, the proximal end of the stent just coincides with the proximal end of the stenosis. If necessary, the biopsy forceps can be used to pull the stent back a little for final precise positioning. confirm.

The present invention provides a stent inserter. There are many methods and ways to specifically realize the technical solution. The above description is only a preferred embodiment of the present invention. It should be pointed out that, for those of ordinary skill in the art, On the premise of departing from the principle of the present invention, some improvements and modifications can also be made, and these improvements and modifications should also be regarded as the protection scope of the present invention. All components that are not specified in this embodiment can be realized by existing technologies.

Claims (5)

1. A tracheal stent implanter, characterized in that it comprises an outer tube for placing the stent, the far end of the outer tube is provided with a head structure, and the outer tube is provided with a wire core and a middle tube fixedly connected with the head structure , there is no inner tube; before the tracheal stent is released, the tracheal stent is located between the outer tube and the wire core and between the tail end of the head structure and the middle tube; The diameter of the outer tube is less than 2.8mm and can be inserted into the bronchoscope forceps channel; When the stent needs to be released, the head structure, wire core and middle tube remain in a fixed position, the outer tube is withdrawn, the stent is released, and then the head structure, wire core and middle tube are withdrawn. 2. A tracheal stent implanter according to claim 1, wherein the head structure is a hard structure. 3. A tracheal stent implanter according to claim 1, wherein the head structure is a soft structure. 4. A tracheal stent implanter according to claim 3, characterized in that, the end of the head structure facing away from the outer tube is provided with a slender and elongated hose that can be developed, and the wire core passes through the lengthened soft tube. The center of the tube, where the end of the core sits inside the extension hose. 5 . The tracheal stent implanter according to claim 1 , wherein marks are printed on the outer tube at a position corresponding to the proximal end of the stent and at a position 10 mm away from the proximal end of the stent. 6 .