A retrievable bronchial occluder system

Abstract

A retrievable bronchial occluder system comprises an occluder, a delivery member, a delivery sheath, a recovery member and a recovery sheath; the occluder comprises an upper end, a support body and a lower end, one end of the support body is connected to the upper end, and the other end is connected to the lower end, the upper end and / or the lower end is provided with a recovery hook, and the delivery member can be connected to the recovery hook; during the delivery process, the delivery member is connected to the occluder and retracted into the delivery sheath, and when pushed to the target bronchus, the occluder is pushed out of the delivery sheath to release the occluder; during the recovery process, the recovery member is connected to the recovery hook, and the occluder is retracted to the recovery sheath through the recovery member for withdrawal.

Description

Technical Field

[0001] The invention relates to the field of medical surgery, and in particular to a blocking device used in bronchial fistula or bronchial artery rupture bleeding surgery. Background Art

[0002] At present, respiratory diseases such as bronchopleural fistula and refractory pneumothorax are seriously endangering people's health, not only increasing the patient's treatment costs and prolonging hospitalization time, but also leading to death once the condition worsens. Bronchopleural fistula is an abnormal channel formed between the bronchus and the pleura. It can be caused by a variety of reasons, such as tuberculous empyema, lobar pneumonia, lung abscess and postoperative infection. It is formed because the pus of chronic empyema corrodes the adjacent lung tissue and then penetrates the bronchus, or because the lesions in the lungs directly invade the chest cavity or rupture into the pleural cavity to form a fistula, and it is also caused by chest puncture or surgical resection of the pus cavity infection. Pus can be coughed up from the bronchi. In severe cases, a large amount of pus is sucked into the bronchi, which can suffocate the patient to death.

[0003] Bronchoscopy-assisted endobronchial occlusion is a new medical method developed in recent years for the treatment of bronchopleural fistula. Its principle is to block the drainage bronchus of bronchopleural fistula under bronchoscopy to achieve the purpose of sealing the fistula. The clinical indications for bronchial occluders include emphysema, bullae, bronchopleural fistula, intractable hemoptysis, cavitary tuberculosis, etc.

[0004] When modern medicine treats this disease, after all complications are effectively controlled, the fistula injection technology is used through fiberoptic bronchoscopy to fill the fistula to achieve the purpose of treatment. However, the disadvantage is that it is easy to relapse in the short term and needs to be refilled, and it is not suitable for multiple refills. Therefore, the treatment of this disease is mainly based on thoracotomy, and there is no suitable device to treat patients who are not suitable for secondary thoracotomy. Endobronchial occlusion treatment under bronchoscopy is an effective bronchoscopic interventional technology that can save patients from video-assisted thoracic surgery (VATS) or other surgical operations, reduce medical expenses, and shorten patients' hospitalization time. However, the bronchial occluders currently used in clinical practice are all for congenital atrial septal defect, ventricular septal defect or patent ductus arteriosus. Since this type of occluder is specially designed for congenital heart disease, sometimes it is not possible to find a size suitable for the bronchus to be blocked, and it is not designed to fit the shape of the bronchus to be blocked, it is not easy to completely block, and it is easy to be skewed or even fall off into the pleural cavity. Due to factors such as air pollution and an aging population, the number of lung cancer patients has increased, and the number of patients undergoing lobectomy or radical resection of lung cancer has also increased year by year. The number of patients with infection and poor healing after lung resection and bronchopleural fistula has also gradually increased. Once a bronchopleural fistula occurs, if it is not treated promptly and effectively, it may not heal for a long time, causing infection in the affected pleural cavity and the formation of empyema. Patients with such empyema generally cannot tolerate reoperation. Bronchial occlusion plus chest lavage and drainage are the most effective means of treating such patients.

[0005] Bronchopleural fistula is caused by the pus of chronic empyema corroding the adjacent lung tissue and then piercing the bronchus, or by the direct invasion of the thoracic cavity by the lesions in the lung or rupture into the pleural cavity to form a fistula, or by infection of the pus cavity caused by thoracentesis or surgical resection. The pus can be coughed up from the bronchi, and in severe cases, a large amount of pus is sucked into the bronchi, which can suffocate the patient to death.

[0006] Patent CN203074768U mentions that a pull wire is set inside the open end of the mesh tube-shaped occluder to facilitate the removal of the occluder. When it needs to be removed, the occluder can be pulled out by simply clamping the pull wire with a clamp. However, the design structure of the occluder cannot be compressed into the recovery sheath again, which will cause great damage to the bronchial endothelium. At the same time, there is no special design for clamping the occluder through the bronchus, and it is difficult to achieve this operation clinically. Summary of the invention

[0007] The end closer to the operator is defined as the proximal end, and the end farther from the operator is defined as the distal end.

[0008] The technical problem solved by the present invention is: to provide a retrievable bronchial occluder system, after the bronchial occlusion process is completed, the occluder can be compressed into a retrieval sheath to reduce the damage to the bronchial endothelium during the withdrawal process; and through the design of the retrieval hook on the occluder of the present invention, the occluder of the present invention can be released antegradely through the natural channel from the trachea to the bronchus, and can also be released retrogradely through the chest wall channel.

[0009] In order to solve the above technical problems, the technical solutions adopted are as follows:

[0010] A retrievable bronchial occluder system includes an occluder, a delivery member, a delivery sheath, a recovery member and a recovery sheath; the occluder includes an upper end, a support body, and a lower end, one end of the support body is connected to the upper end, and the other end is connected to the lower end, the upper end and / or the lower end is provided with a recovery hook, and the delivery member can be connected to the recovery hook; during the delivery process, the delivery member is connected to the occluder and retracted in the delivery sheath, and when it is pushed to the target bronchus, the occluder is pushed out of the delivery sheath to release the occluder; during the recovery process, the recovery member is connected to the recovery hook, and the occluder is retracted to the recovery sheath through the recovery member for withdrawal. The occluder can be released antegradely through the natural channel from the trachea to the bronchus, and can also be released retrogradely through the chest wall channel.

[0011] Preferably, the support body is a mesh structure woven by memory alloy wires. More preferably, the memory alloy wires are nickel-titanium alloy wires.

[0012] Preferably, there is an elastic filler in the mesh structure. More preferably, the filler is a mass or a film.

[0013] Preferably, the filler may be coated, encapsulated or impregnated with the drug.

[0014] Preferably, the membrane is a radial flow-blocking membrane. More preferably, the flow-blocking membrane is a non-woven fabric or a polytetrafluoroethylene fiber membrane.

[0015] The upper end and / or the lower end is an open tubular structure. The opening direction of the open tubular structure extends in the radial direction of the bronchial blocker body and deflects in the axial direction. A nut structure is provided in the open tubular structure, which can be connected with the screw at the distal end of the conveying member. A ferrule is provided on the recovery member, and the ferrule can be connected to the recovery hook.

[0016] The occluder can be in the shape of a strawberry, mushroom, bottle cork, or "I" (Chinese character).

[0017] When the occluder is first released through the bronchus and then recovered through the chest cavity, the upper end of the distal end is provided with a recovery hook, and the tubular structure of the lower end of the proximal end is provided with a nut structure.

[0018] When the occluder is first released through the chest cavity and then recovered through the bronchus, the upper end of the distal end is provided with a recovery hook, and the tubular structure of the lower end of the proximal end is provided with a nut structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 .Schematic diagram of strawberry-shaped occluder

[0020] Figure 2 . Figure 1 Right view

[0021] Figure 3A . Main view of the upper end

[0022] Figure 3B .Right view of the upper end

[0023] Figure 4A . Front view of the lower end

[0024] Figure 4B .Left view of the lower end

[0025] Figure 4C Schematic diagram of the transverse section of the lower end

[0026] Figure 5A .Conveyor parts diagram

[0027] Figure 5B . Schematic diagram of the conveying process

[0028] Fig. 6A .Schematic diagram of the arrest department

[0029] Figure 6B .Schematic diagram of the capture part, retrieval sheath and occluder

[0030] Figure 6C .Schematic diagram of the recycling process

[0031] Figure 7 .Schematic diagram of flow barrier

[0032] Figure 8 . Schematic diagram of mushroom-shaped occluder

[0033] Fig. 9 .Schematic diagram of bottle plug closure

[0034] 1. Upper end 2. Support body 3. Blocking membrane 4. Lower end 5. Hook 6. Delivery part 7. Delivery sheath 8. Retrieval sheath 9. Occluder 10. Catch device 11. Retrieval part 12. Loop 13. Handle DETAILED DESCRIPTION

[0035] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and implementation methods. It should be understood that the specific implementation methods described herein are only used to explain the present invention and are not used to limit the present invention. The scope of this application is not limited by these implementation methods, but is subject to the scope of the patent application. In order to provide a clearer description and enable those familiar with the art to understand the application content of this application, the various parts in the diagram are not necessarily drawn according to their relative sizes, and the ratio of certain sizes to other related scales will be highlighted and exaggerated, and irrelevant or unimportant details are not fully drawn, in order to make the diagram simple.

[0036] like Figure 1-9 As shown, it illustrates a retrievable bronchial occluder system constructed and operated according to an embodiment of the present invention, including an occluder 9, a delivery member 6, a delivery sheath 7, a ferrule 12, a retrieval member 11 and a retrieval sheath 8. The occluder 9 can be retracted in the delivery sheath 7 and delivered to the target bronchus through the delivery member 6. After the bronchial occlusion process is completed, the occluder 9 can be compressed to the retrieval sheath 8 for withdrawal to reduce damage to the bronchial endothelium during the withdrawal stage; and the occluder of the present invention can be released antegradely through the natural passage from the trachea to the bronchus, and can also be released retrogradely through the chest wall passage.

[0037] like Figure 1-2 As shown, it illustrates the recyclable bronchial occluder of the present invention, including an upper end 1, a support body 2, a flow-blocking membrane 3, a lower end 4, and a recovery hook 5 arranged on the upper end 1 or the lower end 4. The support body 2 of the occluder is composed of a plurality of medical nickel-titanium alloy wires or other memory alloy wires extending radially from the top of the occluder to the periphery obliquely, the support body 2 is a mesh structure, and the flow-blocking membrane 3 is distributed along the transverse cross-section of the mesh structure. A plurality of nickel-titanium alloy wires or memory alloy wires are fixed in the upper end 1 by mesh forging, extrusion or welding, and the ends of the alloy wires can also be fixed and constrained in the lower end 4 by forging, extrusion or welding, and the upper end 1 and the lower end 4 are on a center line, and the ends of the upper end 1 and the lower end 4 are both provided with a recovery hook 5, or only the upper end 1 can be provided with a hook, or only the lower end 4 can be provided with a hook. The upper end 1 and the lower end 4 are cylindrical tubes with one end open, and there can be a threaded structure in the tube structure. The mesh of the mesh structure of the support body 2 is a diamond or square structure, and can be designed into a variety of different shapes in order to fit the blocked bronchial part well, such as Figure 1 Strawberry-shaped, as shown Figure 8-9The mushroom-shaped, bottle-cork-shaped or "I-shaped" occluders shown in the figure are shown in the figure. A mushroom-shaped occluder can be used for the right upper lobe bronchus, an I-shaped occluder can be used for the right lower lobe and left upper lobe bronchus, a strawberry-shaped occluder can be used for the left lingular bronchus, and a bottle-cork-shaped occluder can be used for the left lower lobe bronchus. The range of the support body after compression is 4F to 8F; the outer diameter range of the support body after expansion is 4 to 22mm, and the length range of the support body after expansion is 5 to 50mm.

[0038] like Figure 3A-3B as well as Figures 4A-4C As shown, the upper end 1 and the lower end 4 can be provided with a recovery hook 5 at one or both ends, which can be made of medical metal materials (stainless steel or nickel-titanium alloy). The upper end 1 and the lower end 4 are open tubular structures, and the opening direction extends in the radial direction of the bronchial occluder body and deflects in the axial direction. There is a nut structure inside the open tubular structure, and the diameter of the internal threaded hole can be 0.9mm and the depth can be 1.5mm. The recovery hook 5 can be connected to the screw at the distal end of the conveying member 6, so that the conveying member 6 can be controlled by the recovery hook 5 and convey the occluder 9 to the distal end. In addition, since the upper end 1 and the lower end 4 of the occluder 9 of the present invention can be provided with a recovery hook 5 at one or both ends, the recyclable bronchial occluder system of the present invention can be released antegradely through the natural channel from the trachea to the bronchus, and can also be released retrogradely through the chest wall channel.

[0039] Figure 5A-5B As shown, the proximal end of the delivery member 6 is connected to the handle 13. During the delivery of the occluder 9, the occluder 9 is retracted in the delivery sheath 7, and the handle 13 delivers the occluder 9 to the distal end through the delivery member 6. After the occluder 9 is fully expanded and fixed, it is left in the target bronchial cavity to complete the entire bronchial occlusion process. Figures 6A-6C As shown, the catcher 10 is connected to the recovery piece 11, and the recovery piece 11 is provided with a looper 12. When the occluder 9 is recovered, the looper 12 can be connected to the recovery hook 5. The recovery piece 11 is pulled proximally by the catcher 10, so that the looper 12 retracts the occluder 9 into the recovery sheath 8 through the recovery hook 5, thereby completing the entire recovery process, which greatly avoids damage to the bronchial endothelium during the withdrawal stage.

[0040] The support body 2 may be provided with a filler with a certain elasticity. The filler may be designed to be in the shape of a mass or a film. The filler may maintain a good compression state during the occluder delivery process, and may recover its shape together with the occluder support body 2 after the occluder is released. The filler may be coated with, wrapped with, or soaked with one or more drugs such as antibacterial drugs (including anti-tuberculosis drugs), antiallergic drugs, or hemostatic drugs. A suitable drug carrier may also be selected according to the situation, such as polylactic acid. If the filler is designed as a radial flow-blocking membrane 3, such as Figure 7As shown. The flow-blocking membrane 3 can be made of non-woven fabric or polytetrafluoroethylene fiber membrane, and can be designed as a single layer or multiple layers, and can be filled with gel or drug-containing gel injected into the mesh structure of the support body 2 of the occluder. The flow-blocking membrane 3 can play a role of strict sealing on the one hand, and the drugs contained in it can also play a corresponding therapeutic effect on the other hand.

[0041] During the operation, under the fluoroscopy of the X-ray machine, after the target bronchus to be blocked is determined by the fiberoptic bronchoscope and positioned on the body surface, the guide wire is introduced into the target bronchial cavity to be blocked through the biopsy working channel of the fiberoptic bronchoscope; then, under the dual positioning of direct vision of the fiberoptic bronchoscope and X-ray fluoroscopy, the occluder 9 is sent into the target bronchus along the guide wire, and then the guide wire is withdrawn; specifically, the occluder 9 connected to the conveying member 6 is slowly sent to the target bronchus to be blocked; then the occluder 9 is pushed out of the conveying sheath 7, and after the occluder 9 is fully expanded and fixed, the conveying member 6 is rotated to separate the conveying member 6 from the occluder 9, the conveying member 6 and the conveying sheath 7 are withdrawn, and the occluder 9 is left in the target bronchial cavity to complete the entire bronchial occlusion process. During recovery, slowly insert the matching recovery component 11 and the recovery sheath 8, hook the recovery hook 5 of the occluder 9 with the looper 12, pull the catcher 10 toward the proximal end, so that the occluder 9 enters the recovery sheath 8, and after the occluder 9 completely enters the recovery sheath 8, withdraw the catcher 10 toward the proximal end, retract the recovery sheath 8 and the occluder 9, and the recovery process is completed.

[0042] The above is only a preferred embodiment of the present application, so that those skilled in the art can understand or implement the invention of the present application. It will be obvious to those skilled in the art that various modifications and combinations of these embodiments, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A retrievable bronchial occluder system, characterized in that: The system comprises an occluder, a delivery member, a delivery sheath, a recovery member and a recovery sheath; the occluder comprises an upper end, a support body and a lower end, one end of the support body is connected to the upper end, and the other end is connected to the lower end, the upper end and the lower end are integrally formed with a recovery hook, and the recovery hook is an open tubular structure, and the upper end and the lower end are open tubular structures; a nut structure is provided in the open tubular structures of the upper end and the lower end, which can be connected to the screw at the distal end of the delivery member; during the delivery process, the delivery member is connected to the occluder and retracted into the delivery sheath, and when pushed to the target bronchus, the occluder is pushed out of the delivery sheath to release the occluder; during the recovery process, the recovery member is connected to the recovery hook, and the occluder is retracted to the recovery sheath through the recovery member for withdrawal; The occluder can be released antegradely through the natural passage from the trachea to the bronchus, or can be released retrogradely through the chest wall passage.

2. The occluder system according to claim 1, characterized in that: The support body is a mesh structure woven from memory alloy wires.

3. The occluder system according to claim 2, characterized in that: The mesh structure has elastic fillers.

4. The occluder system according to claim 2, characterized in that: The memory alloy wire is a nickel-titanium alloy wire.

5. The occluder system according to claim 3, characterized in that: The filler is a mass-like object or a film-like object.

6. The occluder system according to claim 5, characterized in that: The filler may be coated, encapsulated or impregnated with the drug.

7. The occluder system according to claim 5, characterized in that: The membrane-like object is a radial flow-blocking membrane.

8. The occluder system according to claim 7, characterized in that: The flow-blocking membrane is a non-woven fabric or a polytetrafluoroethylene fiber membrane.

9. The occluder system according to claim 1, characterized in that: The opening direction of the open tubular structure extends in the radial direction of the bronchial occluder body and deflects in the axial direction.

10. The occluder system according to claim 1, characterized in that: The recovery component is provided with a looper, and the looper can be connected with the recovery hook.

11. The occluder system according to any one of claims 1 to 10, characterized in that: The occluder is in the shape of a strawberry, a mushroom, a bottle stopper or an I-shaped.

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