WO2013113271A1

WO2013113271A1 - Bronchial valve and manufacturing method thereof

Info

Publication number: WO2013113271A1
Application number: PCT/CN2013/071093
Authority: WO
Inventors: 林伟林; 李安宁
Original assignee: 先健科技(深圳)有限公司
Priority date: 2012-01-30
Filing date: 2013-01-29
Publication date: 2013-08-08
Also published as: CN102580171B; CN102580171A

Abstract

Disclosed is a bronchial valve and manufacturing method thereof. The bronchial valve comprises a shrinkable frame (302) and a continuous isolating film (304) covering the frame (302). The frame (302) comprises a proximal end (307),a distal end (306) and at least three longitudinal beams (301) coupled between the proximal end (307) and the distal end (306), wherein each longitudinal beam (301) comprises a distal bend portion (3011) coupled with the distal end (306), and a proximal bend portion (3012) coupled with the proximal end (307) respectively. One end of the isolating film (304) coats the distal end (306) of the frame (302), and the other end of the isolating film (304) has an edge (305), wherein the edge (305) is located between the distal bend portion (3011) and the proximal bend portion (3012) of the longitudinal beam (301). By utilizing the frame structure of the closed type, the bronchial valve not only improves the supporting force and stability of the frame, but also decreases the number of protruding corner points in contact with the inner wall of the bronchia, which in turn decreases the damage rate to the inner wall of the bronchia caused thereby and the rate of occurrence of bronchitis.

Description

Bronchial valve and manufacturing method thereof

Technical field

The invention relates to the field of medical instruments, in particular to a bronchial valve and a manufacturing method thereof.

Background technique

Chronic obstructive pulmonary disease such as emphysema is a common disease, especially in the elderly. Traditionally, the treatment of emphysema generally includes medical treatment and surgical treatment. Medical treatment includes oxygen inhalation, prevention of pulmonary infection, bronchial spasm, etc., but the curative effect is extremely limited; surgical treatment is mainly based on lung volume reduction surgery, and there are also many limitations, such as: strict surgical indications, existence More complications, anesthesia and anesthesia-related complications, preoperative efficacy is difficult to predict, postoperative can not make up for the unsatisfactory results caused by excessive or too little resection, high surgical costs and greater mental and physical Pain, and because some patients have poor lung function and often cannot tolerate surgery, the postoperative mortality is high, which limits the application of surgery. According to statistics, the 5-year survival rate of patients with end-stage emphysema is less than 50%.

In order to better treat emphysema, improve the quality of life of patients, and reduce the trauma of patients during the operation, international studies have used bronchoscopy to perform emphysema. At present, the main bronchial valves used in the international market are the duckbill bronchial flap and the umbrella bronchial valve.

Referring to Figure 1, there is shown a schematic view of the structure of a duckbill bronchial valve in the prior art. The frame 101 includes two portions of a resilient support mesh 102 and a valve support 103 that are coupled to the valve support 103 by five longitudinal members 104. The two sheets of silicone rubber membrane form a one-way opening forming a duckbill-shaped valve 105 that fits within the valve support 103. The frame 101 and the duckbill valve 105 are covered with a layer of insulating film 106 made of silicone rubber, and the duckbill valve 105 is firmly bonded to the frame 101 through the insulating film 106.

The duckbill bronchial valve is placed in a suitable position in the bronchus, so that the bronchial end and its connected emphysema area constitute a relatively closed space, and the structure of the duckbill valve 105 can prevent outside air from entering the emphysema area. The gas or secretion in the tissue of the emphysema region is allowed to be discharged from the opening of the duckbill valve 105, thereby promoting the occurrence of lung collapse in the emphysema region, and achieving the purpose of treating/improving the emphysema disease.

For the first time, Snell et al. used a duck-billed bronchial valve for 10 patients with emphysema. After 11 duckbill bronchial flaps, the symptoms of the 4 patients were significantly improved. Although the indicators such as the vital capacity test and the 6-minute walking test did not change significantly, the patient's lung carbon dioxide diffusion increased by 11% after one month. Complications occurred, such as: 1 case of asymptomatic pneumothorax, 1 case of left lower lobe pneumonia on the 37th day after surgery, and 3 cases of worsening COPD. Many scholars have reported the effects of this method, such as: Hopkinson et al, Yim et al, deOliviera, etc., and Toma et al. Their research laid the foundation for large-scale transbronchial lung volume reduction (BLVR) clinical research. The foundation was approved by the US Food and Drug Administration (FDA) for a randomized controlled trial of the duckbill bronchial valve.

The above duckbill bronchial valve has the following defects:

a. After the above-mentioned duckbill bronchial valve is placed, it may be due to the fact that the support mesh 102 has more bulge nodes in contact with the inner wall of the bronchus, and a small amount of mucosal granuloma lesions are caused around the frame 101.

b. The duckbill bronchial valve has an open structure at both ends, which is not suitable for loading the controllable connecting device and the recycling component at the end of the instrument. Therefore, the release process is uncontrollable, and the condition of the frame 101 jumping forward occurs, and the position in the emphysema area cannot be accurately positioned; in addition, when the release position is wrong, the instrument cannot be retracted into the sheath tube and then released again. Moreover, when the instrument is recovered, the valve support 103 is clamped by a biopsy forceps, and the frame 101 is pulled in the air tube by the biopsy forceps, instead of recovering the instrument into the sheath, so the frame 101 will rub the inner wall of the air tube. It is likely to damage the inner wall of the trachea.

c. The human body relies on the back and forth of the mucosal cilia of the bronchial wall, and the secretion of the tissue in the emphysema area is gradually transferred from the alveolar to the tracheal outlet, thereby achieving the purpose of discharging secretions. However, from the clinical use effect of the duckbill bronchial valve, there is still a phenomenon that the airflow such as pneumothorax and secretions are blocked, which may be because the opening of the duckbill valve 105 is located in the middle of the valve support 103, and the duckbill valve 105 openings away from the mucosal cilia on the inner wall of the bronchus, can not naturally discharge secretions through the bronchial mucociliary movement, and the gap width of the opening of the duckbill valve 105 is limited, which easily leads to the secretion of secretions, and secretions must be coughed from the gap.

Referring to Fig. 2, it is a schematic longitudinal sectional view of a prior art umbrella bronchial valve 201. The umbrella bronchial valve 201 includes a resilient frame 202, a barrier film 207, and a connecting rod 203. The frame 202 includes six struts 204 and five anchors 205. The connecting rod 203 is connected with a recycling handle 206, and a polyurethane film is attached to the outer surface of the struts 204 to form an umbrella-shaped insulating film 207.

After the umbrella bronchial valve is placed in the bronchus, the end away from the human mouth is called the distal end (the end of the anchor 205 is provided), and the opposite end is the proximal end (the end of the recovery handle 206 is provided). The insulating membrane 207 is in close contact with the inner wall of the bronchus, thereby preventing the outside air from entering the tissue of the emphysema region from the proximal end to the distal end, and the design of the umbrella structure can make the secretion in the lung of the emphysema region along the insulating membrane 207 and the bronchus. The narrow gap between the inner walls is discharged from the distal end to the proximal end, and the lung tissue of the emphysema area is collapsed by restricting the ventilation of the lung tissue in the emphysema area.

However, the above umbrella bronchus still has the following defects:

a. After the above-mentioned umbrella-shaped bronchial valve is placed, there may be a small number of mucosal granuloma lesions around the frame 202 due to the large number of protruding nodes that the frame 202 contacts the inner wall of the bronchus. In addition, because the anchor 205 is too long, it will damage the inner wall of the bronchus, and also increase the risk of complications such as bronchitis.

b. The umbrella-shaped bronchial valve is an open structure at both ends, and the release process is uncontrollable. There is a situation that the frame 202 jumps forward and cannot be accurately positioned in the emphysema area. In addition, when the release position is found to be incorrect, the device cannot be placed. Retracted into the sheath and re-released. Moreover, when the instrument is recovered, the biopsy forceps is used to clamp the recovery handle 206, and then the instrument is directly dragged in the air tube for recovery, instead of retracting the instrument into the sheath tube, so the distal ends of the anchor rod 205 and the strut 204 are damaged. The inner wall of the trachea also hinders the recovery of the instrument.

c. The struts 204 and the anchor rods 205 of the umbrella bronchial valve are connected together by welding. The struts 204 and the anchor rods 205 are elastic and the ends thereof extend independently of each other. Therefore, the struts 204 and the anchor rods 205 are The ends are easily bent and deformed. When the umbrella-shaped bronchial valve is placed behind the bronchus, once the struts 204 and the anchor 205 are deformed non-axisymmetrically, the umbrella-like structure is easily inclined, resulting in a large gap between the insulating membrane 207 and the bronchial wall, thereby The loss of the umbrella bronchial flap prevents the entry of external gases into the tissue of the emphysema area.

Summary of the invention

The main object of the present invention is to provide a bronchial valve which aims to improve the supporting force and stability of the blister frame of the bronchial valve while ensuring the discharge capacity of the secretion in the emphysema region.

The present invention provides a bronchial valve comprising a collapsible frame and a continuous insulating membrane covering the frame, the frame comprising a proximal end, a distal end and at least three longitudinal beams connected between the proximal end and the distal end, each The longitudinal beams respectively include a distal bending portion connected to the distal end, and a proximal bending portion connected to the proximal end, one end of the insulating film covering the distal end of the frame, the insulating film The other end has an edge and the edge is between the distal bend and the proximal bend of the stringer.

Preferably, the frame is an axisymmetric structure, the axis of the frame passes through the proximal end and the distal end, and a portion between the distal bent portion and the proximal bent portion of each of the longitudinal beams is parallel to The axis.

Preferably, the frame comprises five to seven of said stringers.

Preferably, a film-filling groove is provided between the distal end bent portion and the proximal bent portion of the at least one longitudinal beam, and the insulating film fills the coating film groove.

Preferably, the film groove penetrates the inner side surface and the outer side surface of the stringer.

Preferably, the coating groove is circular or elliptical, or the coating groove is elongated and has an aspect ratio greater than 2:1.

Preferably, in the longitudinal beam disposed in the film groove, at least one film groove is disposed on each of the longitudinal beams, the edge of the insulation film is filled with a film groove farthest from the distal end of the longitudinal beam, and The barrier film wraps a portion of the stringer from the film groove that is furthest from the distal end to the distal end.

Preferably, the barrier film comprises an outer layer film, a base film and an inner layer film, the base film being located between the inner layer film and the outer layer film.

Preferably, the base film is an expanded polytetrafluoroethylene film attached to an outer side surface and/or an inner side surface of the stringer.

Preferably, the inner layer film and the outer layer film are both colloidal, and the gum is formed by a vulcanization reaction of the rubber raw solution.

Preferably, the rubber raw solution is a silicone rubber solution or a polyurethane solution.

Preferably, the insulating film has a thickness of 10 to 100 μm, and the base film has a thickness of 5 to 50 μm or 30% to 60% of the thickness of the insulating film.

Preferably, at least one anchor is further disposed on an outer side surface of at least one of the longitudinal beams, the anchor being located between an edge of the insulating film and a proximal bent portion of the longitudinal beam.

Preferably, the anchor extends 1 to 3 millimeters to the outside of the frame and is switchable between two states of obliquely pointing the distal end and contracting back to the outer surface of the longitudinal beam.

Preferably, the proximal end of the frame is provided with attachment means for cooperating with the delivery means or recovery means for placement or retrieval of the bronchial valve.

Another object of the present invention is to provide a method of making a bronchial valve which aims to increase the tensile strength of the barrier film on the frame and to make the barrier film more likely to adhere to the frame.

The invention provides a bronchial valve, wherein the bronchial valve is a bronchial valve of the above structure, and the manufacturing method comprises the following steps:

Making the frame;

The insulating film is fabricated on the frame.

Preferably, the insulating film comprises a base film, an inner film and an outer film; and the step of forming the insulating film on the frame comprises:

Making the base film on the frame;

A pre-formed rubber original solution is coated on the base film, and the rubber raw solution on the base film is vulcanized to form the inner layer film and the outer layer film.

Preferably, the vulcanization comprises:

If the base film on the frame is coated with a silicone rubber solution, the vulcanization temperature is 120 to 140 ° C, and the vulcanization time is 5 to 10 minutes;

If the base film on the frame is coated with a polyurethane solution, the vulcanization temperature is 120 to 130 ° C, and the vulcanization time is 15 to 20 minutes.

Compared with the prior art, the invention has the following advantages:

1. By adopting a closed frame structure, the invention not only improves the support force and stability of the frame, but also ensures the discharge of secretions in the emphysema area, and also reduces the point of contact with the inner wall of the bronchus, thereby reducing the bronchi. The damage rate of the inner wall reduces the incidence of bronchitis.

2. Compared with the prior art single-layer polymer film structure, the insulating film of the present invention adopts a multilayer polymer film structure, thereby having higher tensile strength.

3. The present invention can be used to control the release of the bronchial valve by means of a connecting device for placing and recovering the bronchial valve, so that the bronchial valve can be moved through the connecting device, thereby achieving more precise positioning of the emphysema. In the process of bronchial valve recovery, the entire device can be pulled back by the recovery component on the connecting device, and the closed frame is compressed by the sheath port into the sheath tube, thereby recovering the device into the sheath tube. The purpose is to avoid damage to the inner wall of the bronchus during the recycling process and to safely recover the device.

4. Compared with the prior art coating process, the film coating process of the present invention does not require a mold, and the manufacturing cost is lower. Moreover, the film coating process of the present invention does not require the use of a mold as a carrier, does not introduce contamination, and does not destroy the integrity of the film layer during the process of disassembling the mold.

DRAWINGS

1 is a schematic view showing the structure of a duckbill bronchial valve in the prior art;

2 is a schematic longitudinal sectional view of a prior art umbrella bronchial valve;

Figure 3 is a schematic longitudinal sectional view of a preferred embodiment of the bronchial valve of the present invention;

4 is a schematic structural view of an embodiment of a film-coated groove on a longitudinal beam of a bronchial valve of the present invention;

Figure 5 is a schematic view showing the structure of another embodiment of the film-forming groove on the longitudinal beam of the bronchial valve of the present invention;

Figure 6 is a schematic longitudinal sectional partial structural view of the vicinity of the edge of the bronchial flap of the present invention, in which the base film is on the outer side surface of the longitudinal beam;

Figure 7 is a schematic view showing another longitudinal section of the vicinity of the edge of the bronchial flap of the present invention, wherein the base film is on the inner side surface of the stringer;

Figure 8 is a schematic view of an anchor piercing engraved on a stringer in the bronchial valve of the present invention;

Figure 9 is a side elevational view of the longitudinal beam of the bronchial valve of the present invention when the anchor is opened;

Figure 10 is a schematic view showing the structure of the frame in the bronchial valve of the present invention;

11 is a schematic flow chart of a preferred embodiment of a method for fabricating a bronchial valve of the present invention;

12 is a schematic flow chart of a preferred embodiment of a manufacturing frame in a method for fabricating a bronchial valve according to the present invention;

13 is a schematic flow chart of a preferred embodiment of forming a barrier film on a frame in a method for fabricating a bronchial valve according to the present invention;

Fig. 14 is a schematic view showing the manufacturing process of the coated base film in the method for producing the bronchial valve of the present invention.

The implementation, functional features, and advantages of the present invention will be further described in conjunction with the embodiments.

detailed description

The technical solutions of the present invention are further described below in conjunction with the drawings and specific embodiments. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Referring to Figure 3, there is shown a longitudinal cross-sectional view of a preferred embodiment of the bronchial valve of the present invention. The bronchial valve includes a closed collapsible (elastic) frame 302 and a continuous insulating membrane 304 overlying the frame 302, the frame 302 including a proximal end 307, a distal end 306, and a proximal end 307 and a distal end 306. At least three longitudinal members 301, preferably five to seven. Each of the longitudinal beams 301 is respectively provided with a distal bending portion 3011 and a proximal bending portion 3012. The longitudinal beam 301 is connected to the proximal end 307 through its proximal bending portion 3012, and passes through the distal bending portion thereof. 3011 is coupled to remote end 306. For convenience of description, the portion between the distal bent portion 3011 of the stringer 301 and the proximal bent portion 3012 is referred to as a "middle portion". One end of the insulating film 304 covers the distal end 306 of the frame 302, the other end has an edge 305, and the edge 305 is located between the distal bent portion 3011 of the stringer 301 and the proximal bent portion 3012. In a preferred embodiment, the frame 302 is an axisymmetric structure having an axis passing through a distal end 306 and a proximal end 307, the central portion of which may be parallel to the axis.

After the bronchial valve is placed in the bronchus, the distal end 306 is the end away from the human mouth, and the proximal end 307 is close to the human mouth. Moreover, the bronchial valve is pre-compressed in a sheath, the sheath is placed in the bronchus and the bronchial valve is pushed out of the sheath, and the frame 302 is automatically radially expanded from the previously compressed state, so that the elastic stringer 301 Adheres to the inner wall of the bronchi. At this time, the edge 305 of the insulating film 304 also abuts against the inner wall of the bronchus, thereby preventing gas from entering the lung tissue of the emphysema region on the side of the distal end 306 from the outside while allowing secretions in the lung of the emphysema region from the insulating membrane 304. The edge 305 is discharged from the gap between the inner wall of the bronchus, and the purpose of restricting the outside air from entering the lung tissue of the emphysema area and causing the lung tissue to collapse in the emphysema area.

By adopting a closed frame structure, the embodiment of the invention not only improves the supporting force and stability of the frame 302, but also reduces the angle of contact with the inner wall of the bronchus, thereby reducing the damage rate to the inner wall of the bronchus and reducing the bronchitis. The probability of occurrence.

A film groove 303 is provided on at least one of the stringers 301, and the film groove 303 may be disposed in the middle of the stringer 301. Preferably, a plurality of film grooves 303 are respectively disposed on the plurality of symmetrically disposed longitudinal beams 301, and preferably one film groove 303 is provided on each of the longitudinal beams. From each of the lamination grooves 303 to the distal end 306 of the frame 302, a continuous insulating film 304 is covered, and the material of the insulating film 304 is filled in the lamination groove 303. In an embodiment of the present invention, the film groove 303 may be disposed on the inner side surface and/or the outer side surface near the middle portion of the stringer 301, and near the edge 305 of the insulation film 304. Therefore, the edge 305 of the above-mentioned insulating film 304 can penetrate into the coating groove 303, and the adhesion of the insulating film 304 to the longitudinal beam 301 is improved. In another embodiment of the present invention, the film groove 303 penetrates the inner side surface and the outer side surface of the stringer 301. Therefore, the edge 305 of the above-mentioned insulating film 304 can be filled with the coating groove 303, and the insulating film 304 wraps the portion of the longitudinal beam 301 from the coating groove 303 to the distal end 306, further improving the insulating film 304 at the longitudinal beam 301. Adhesion on the top.

The number of the lamination grooves 303 of each of the longitudinal beams 301 may be one or more, and one lamination groove 303 on each of the longitudinal beams 301 farthest from the distal end 306 should be disposed at the edge 305 of the insulation film 304. nearby. Further, the shape of the coating tank 303 may be different. In an embodiment of the invention, the film groove 303 may be an elongated shape having an aspect ratio greater than 2:1, as shown in FIG. In another embodiment of the present invention, in order to increase the bonding force between the edge 305 of the insulating film 304 and the coating groove 303, the coating groove 303 may also be a plurality of elliptical holes, as shown in FIG. In still another embodiment of the present invention, the film groove 303 may also be a plurality of circular holes to avoid reducing the support strength of the stringer 301 here, as shown in FIG.

Referring to FIG. 6, which is a schematic partial cross-sectional view of the vicinity of the edge 305 of the bronchial flap 304 of the present invention, the edge 305 of the insulating film 304 enters the lamination groove 303. The above-described insulating film 304 includes an outer layer film 502, a base film 501, and an inner layer film 503, which is located between the inner layer film 503 and the outer layer film 502. The outer film 502 and the inner film 503 completely wrap the inner and outer surfaces of the stringer 301 from the distal end 306 to the film groove 303 and are filled in the film groove 303 to bond the base film 501 to the stringer 301. Together, it is ensured that the barrier film 304 securely covers the corresponding portion of each of the stringers 301. At the junction between the outer film 502 and the inner film 503, the edge 305 of the insulating film 304 is formed. Moreover, due to the lining action of the base film 501, the edge 305 of the insulating film 304 has better toughness and strength, and the edge 305 of the insulating film 304 can be more closely attached to the inner wall of the bronchus. Preferably, the outer layer film 502 and the inner layer film 503 are both colloidal and obtainable by vulcanization of rubber, and have excellent barrier properties and airtightness.

The above-mentioned insulating film 304 may have a thickness of 10 to 100 μm, for example, 30 μm or 60 μm. The base film 501 has a thickness of 5 to 50 μm, for example, 10 μm or 20 μm, and is attached to the outer side surface of the stringer 301 as shown in FIG. Alternatively, the thickness of the base film 501 is selected to be 30% to 60% of the thickness of the insulating film 304, and preferably the ratio is 50%. Of course, the base film 501 can also be attached to the inner side surface of the stringer 301 as shown in FIG. The base film 501 may also be laminated, and may be respectively attached to the inner and outer surfaces of the stringer 301, for example, a film having both layers of 5 micrometers thick. It should be noted here that if the base film 501 is respectively attached to the inner and outer surfaces of the stringer 301, it needs to be processed during the manufacturing process so that the contact between the two base films 501 is tighter, and the two bases are ensured. The thickness of the film 501 is within the range required to fabricate the barrier film 304. Compared with the single-layer polymer film structure used in the bronchial valve of the prior art, the insulating film 304 of the present invention adopts a multilayer polymer film structure, thereby having higher tensile strength, better impermeability and airtightness.

Referring to Figures 8 and 9, the outer side surface of the longitudinal beam 301 is further provided with an elastic anchor 701 which may be located near the middle of the longitudinal beam 301 and which is neither covered by the insulating film 304 nor covered. The membrane grooves 303 are coincident. Optionally, the anchor 701 is located between the edge 305 of the insulating film 304 and the proximal bent portion 3012 of the longitudinal beam 301, or the anchor 701 is located at the film groove 303 and the longitudinal beam 301 closest to the proximal end 307. Between the proximal bends 3012. In a preferred embodiment of the invention, the anchor 701 is located adjacent the proximal bend 3012 of the stringer 301, as the anchor 701 only needs to follow the direction of the stringer 301 to meet the requirements for bronchial fixation and recovery. Therefore, the anchor thorn 701 is not easy to break. The anchor 701 can be engraved on the stringer 301 by a laser as shown in FIG. After the anchor 701 is shaped by heat treatment, as shown in FIG. 9, when the bronchial valve is in an expanded state, the anchor 701 is also automatically expanded outwardly by about 1 ~ 3 mm, that is, the anchor 701 on the stringer 301 extends to the outside of the frame 302 by about 1 to 3 Mm, able to penetrate the bronchial wall to improve the stability of the bronchial valve. The anchor 701 can be tilted toward the distal end 306 and can also be compressed toward the axis until it coincides with the longitudinal beam 301. Thus, the resilient anchor 701 can be angled toward the distal end 306 and retracted back to the outside surface of the longitudinal beam 301. Between these two states, the bronchial valve can still be smoothly recovered into the sheath, and the anchor 701 does not hinder the recovery.

Referring to Figure 10, the proximal end 307 of the frame 302 described above is provided with a coupling device 401 that cooperates with a delivery device 403 or a retrieval device (not shown) for placement or retrieval of the bronchial valve. For ease of operation, the connection device 401 is a controllable release component. For example, the attachment device 401 is internally threaded and cooperatively coupled to the external thread 405 at the distal end of the delivery cable 404 in the delivery device 403. The attachment device 401 can be separated from the delivery device 403 when the bronchial valve is released. Of course, the connecting device 401 can also be other equivalent controllable release components, such as magnetic connecting devices, elastic snaps, lassos, and the like.

The connecting device 401 is further provided with a recovery member 402. The recovery member 402 in the embodiment of the present invention is a hook-type recovery member. When recovering, the bronchial valve is recovered by tying the recovery member 402 with a device such as a catcher. . Of course, the recovery member 402 may also have a structure such as a recovery handle.

The embodiment of the present invention can be used not only for a closed frame but also for the placement and recovery of the bronchial valve by the connecting device 401. Moreover, during the placement process, the entire device can be pulled by the connecting device 401 to achieve the purpose of controlled release, which can be more accurately positioned in the emphysema region; during the recovery process, through the recycling component on the connecting device 401, It is also possible to move the entire instrument to achieve the purpose of recycling the device into the sheath, avoiding damage to the inner wall of the bronchus during the recovery process, and safer recovery of the device.

Fig. 11 is a flow chart showing an embodiment of a method for producing a bronchial valve according to the present invention.

Referring to Fig. 11, in the method of manufacturing a bronchial valve of the present invention, the bronchial valve is a bronchial valve of the above structure, as shown in Fig. 3. The production method includes the following steps:

Step S01, making a frame 302;

The frame 302 is formed in accordance with the above structure. The material of the frame 302 is preferably a superelastic alloy material. The material used in the frame of the embodiment of the present invention is a nickel-titanium alloy. Of course, other materials meeting medical and mechanical requirements may also be used. The frame 302 shown in Fig. 3 can be integrally formed, and is preferably integrally processed by a nickel-titanium tube.

Referring to FIG. 12, the step of integrally molding the frame 302 may be:

Step S011, cutting a nickel-titanium tube having a diameter of 10 to 30 mm and a wall thickness of 0.1 to 0.5 mm by laser;

Step S012, dividing the middle portion of the nickel-titanium tube into a plurality of longitudinal beams 301 parallel to the axis, and the uncut portions of the nickel-titanium tube having about 1 to 3 mm lengths respectively become the proximal end 306 of the frame 302 and Remote end 307;

The slit groove 303 may be engraved on the stringer 301 while the stringer 301 is divided and formed. For example, one or more of the inner side surface or the outer side surface of each of the side members 301 are respectively engraved; or one or more film grooves 303 penetrating the inner and outer surfaces of the side members 301 are engraved on each of the side members 301, and The shape of the coating groove 303 may be an elongated shape, an elliptical shape, a circular shape, or the like.

Step S013, the cut nickel-titanium tube is expanded into a lantern type by a mold, and heat-treated and shaped.

In step S02, an insulating film 304 is formed on the frame 302.

Referring to FIGS. 6 and 7, the insulating film 304 includes a base film 501, an inner layer film 503, and an outer layer film 502. Therefore, referring to FIG. 13, the foregoing step S02 specifically includes:

Step S021, the base film 501 is formed on the frame 302;

First, the base film 501 is coated on the frame 302, starting from the distal end 306 of the frame 302, and the base film 501 is coated on the inner side surface and/or the outer side surface of the frame 302 to form an umbrella-shaped base film 501, and the base film The shape and position of the 501 is consistent with the desired shape and position of the barrier film 304. Specifically, one end of the base film 501 covers the distal end of the frame 302, and the other end has an edge, and the edge is located at the distal end bent portion 3011 and the proximal end bent portion 3012 of the longitudinal beam 301. In the embodiment of the present invention, the base film 501 is a microporous expanded polytetrafluoroethylene (ePTFE) film having a thickness of about 5 to 50 micrometers, and may also have biocompatibility requirements and micropores. And can achieve the equivalent effect of the film. The base film 501 easily adsorbs a rubber raw solution (for example, a silicone rubber solution or a polyurethane solution, etc.).

In step S022, a pre-formed rubber original solution is coated on the base film 501, and the rubber original solution on the base film 501 is vulcanized to form the inner layer film 503 and the outer layer film 502.

Specifically, referring to FIG. 14, the handle 601 is first connected to the connecting device 401 of the proximal end 307 of the frame 302, and the handle 601 is used to immerse the base film 501 on the frame 302 into the rubber original solution of the container 603, and soak for 1 to 5 seconds. The original rubber solution can be completely infiltrated into the micropores of the ePTFE material of the base film 501, and the original rubber solution is also infiltrated into the coating tank 303. Then, the frame 302 is taken out from the container 603, and the excess rubber original solution is allowed to flow away from the edge of the base film 501, at which time a layer of the rubber original solution is adhered to the inner and outer surfaces of the base film 501. Of course, it is also possible to apply the original rubber solution to the base film 501 in other conventional manners, such as spraying or painting.

The above rubber raw solution may be a silicone rubber solution, which can be obtained by the following method:

The basic principle is based on: mixing silica gel, a crosslinking agent and a catalyst (wherein silica gel is a raw material of raw rubber), and forming a silicone rubber by a sulfurization reaction. For example, Wacker's medical grade silicone rubber (SilGel® 612) component A (containing silica gel and cross-linking agent) and component B (catalyst) mixed at a ratio of 1:1 to 10:1 by mass ratio and stirred at room temperature for 5 ~ After 10 minutes, a gel-like substance was obtained, and the gel-like substance was dissolved in a solution such as petroleum ether or toluene, and diluted with a mass ratio of the solute to the solvent of 1:5 to 1:10 to obtain the above-mentioned silicone rubber solution.

The above rubber raw solution may also be a polyurethane solution, which can be obtained by the following method:

Heating methylene bis-o-chloroaniline (3,3'-dichloro-4,4'-diaminodiphenylmethane or di-o-dichlorodiphenylmethane, also known as MOCA) to 115 ~ 120 °C to melt it, weigh 9.5 ~ 15 parts by mass of MOCA as a cross-linking agent, mixed with 100 parts of polyurethane prepolymer (the polyurethane prepolymer is raw material), stir and mix at 80 ~ 100 °C 1 ~ 2 minutes, made of polyurethane solution for use.

Finally, the bronchial valve is placed in an oven for heating, and the base film 501 coated with the rubber original solution is rapidly vulcanized:

If the base film 501 on the frame 302 is coated with a silicone rubber solution, the vulcanization temperature is 120 to 140 ° C, and the vulcanization time is 5 to 10 minutes;

If the base film 501 on the frame 302 is coated with a polyurethane solution, the vulcanization temperature is 120 to 130 ° C, and the vulcanization time is 15 to 20 minutes.

Due to the action of the catalyst, although the vulcanization reaction of the silicone rubber solution or the polyurethane solution can be carried out at room temperature, it takes at least several hours to complete the reaction.

After the vulcanization treatment, the gel outer layer film 502 and the inner layer film 503 are formed on the base film 501, so that the insulating film 304 having a thickness of 10 to 100 μm is obtained and coated on the inner and outer surfaces of the frame 302. The barrier film 304 is thicker than the original base film 501, and preferably has a thickness that is doubled. In addition, during the warm vulcanization process, the handle 601 and the frame 302 can be rotated, so that different portions of the insulating film 304 can be vulcanized quickly and uniformly. Therefore, the barrier film 304 is significantly different in appearance from the original opaque ePTFE film, but is an approximately transparent gel, which is more elastic and lubricious. Moreover, the inner and outer surfaces of the insulating film 304 are smooth and also have good biocompatibility. The strength of the insulation film 304 is also significantly higher than that of the original ePTFE film or a common silicone rubber film of the same thickness or a common polyurethane film, and can provide sufficient tension to be tightly wrapped around each of the stringers 301.

In the embodiment of the present invention, the closed structure is adopted by the frame, and the composite insulating film 304 having the multi-layer polymer film structure is used, and the tensile strength is higher than that of the single-layer polymer film structure of the prior art. Moreover, the film coating process of the present invention does not require a mold to be produced, and the manufacturing cost is lower than that of the prior art film coating process. Moreover, the film coating process of the present invention does not require the use of a mold as a carrier, does not introduce contamination, and does not destroy the integrity of the film layer during the process of disassembling the mold.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the patents. The equivalent structure or equivalent process transformations made by the description of the present invention and the drawings are directly or indirectly applied to other related technical fields. The same is included in the scope of patent protection of the present invention.

Claims

A bronchial valve comprising a collapsible frame and a continuous barrier film overlying the frame, wherein the frame includes a proximal end, a distal end, and at least three longitudinal members connected between the proximal end and the distal end, Each of the longitudinal beams includes a distal bent portion connected to the distal end, and a proximal bent portion connected to the proximal end, one end of the insulating membrane covering the distal end of the frame, the isolating The other end of the membrane has an edge and the edge is between the distal bend and the proximal bend of the stringer.
The bronchial valve according to claim 1, wherein said frame is an axisymmetric structure, said frame having an axis passing through said proximal end and a distal end, and said distal end of each of said longitudinal members is bent Portions between the end bends are all parallel to the axis.
The bronchial valve according to claim 1, wherein said frame comprises five to seven said longitudinal beams.
The bronchial valve according to claim 1, wherein a lamination groove is provided between the distal end bent portion and the proximal end bent portion of at least one of said longitudinal beams, said insulating film filling said coating groove .
The bronchial valve according to claim 4, wherein the film groove penetrates the inner side surface and the outer side surface of the stringer.
The bronchial valve according to claim 4, wherein the film groove is circular or elliptical, or the film groove is elongated and has an aspect ratio of more than 2:1.
The bronchial valve according to claim 4, wherein in the longitudinal beam provided with the film groove, each of the longitudinal beams is provided with at least one film groove, and the edge of the insulation film is filled with the distance of the longitudinal beam The most distal one of the lamination grooves, and the insulating film wraps the portion of the stringer from the farthest film groove farthest to the distal end.
The bronchial valve according to any one of claims 1 to 7, wherein the barrier film comprises an outer layer film, a base film and an inner layer film, the base film being located between the inner layer film and the outer layer film .
The bronchial valve according to claim 8, wherein the base film is an expanded polytetrafluoroethylene film attached to an outer side surface and/or an inner side surface of the stringer.
The bronchial valve according to claim 8, wherein the inner layer film and the outer layer film are both colloidal, and the gum is formed by a vulcanization reaction of a rubber original solution.
The bronchial valve according to claim 10, wherein the rubber original solution is a silicone rubber solution or a polyurethane solution.
The bronchial valve according to claim 8, wherein the insulating film has a thickness of 10 to 100 μm, and the base film has a thickness of 5 to 50 μm or 30% to 60 of the thickness of the insulating film. %.
The bronchial valve according to any one of claims 1 to 7, wherein at least one anchor thorn is further disposed on an outer side surface of at least one of the longitudinal beams, the anchor thorn being located at an edge of the insulating film Between the proximal bend of the stringer.
The bronchial valve according to claim 13, wherein said anchor thorn extends 1 to 3 mm toward the outer side of said frame and is capable of being pointed obliquely toward said distal end and contracted back to the outer side surface of said longitudinal beam Switch between these two states.
The bronchial valve according to any one of claims 1 to 7, wherein the proximal end of the frame is provided with a connecting device, and the connecting device cooperates with the conveying device or the recovery device for the bronchial valve Place or recycle.
A method for manufacturing a bronchial valve, characterized in that the bronchial valve is the bronchial valve according to claim 1, comprising the following steps:

Making the frame;

The insulating film is fabricated on the frame.
The method of manufacturing a bronchial valve according to claim 16, wherein the insulating film comprises a base film, an inner layer film and an outer layer film;

The step of forming the insulating film on the frame specifically includes:

Making the base film on the frame;

A pre-formed rubber original solution is coated on the base film, and the rubber original solution on the base film is vulcanized to form the inner layer film and the outer layer film.
The method of manufacturing a bronchial valve according to claim 17, wherein the rubber raw solution is a silicone rubber solution or a polyurethane solution.
The method of manufacturing a bronchial valve according to claim 18, wherein the vulcanization comprises:

If the base film on the frame is coated with a silicone rubber solution, the vulcanization temperature is 120 to 140 ° C, and the vulcanization time is 5 to 10 minutes;

If the base film on the frame is coated with a polyurethane solution, the vulcanization temperature is 120 to 130 ° C, and the vulcanization time is 15 to 20 minutes.