CN113729830A

CN113729830A - Airway obstruction device

Info

Publication number: CN113729830A
Application number: CN202111134649.9A
Authority: CN
Inventors: 张梅慧; 元苹平; 梁玉晨
Original assignee: Qichen Shanghai Medical Equipment Co ltd
Current assignee: Qichen Shanghai Medical Equipment Co ltd
Priority date: 2021-09-27
Filing date: 2021-09-27
Publication date: 2021-12-03

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an airway obstruction device. An airway obstruction device includes a support structure that is hollow and has a flow passage from a proximal end to a distal end; and the one-way blocking structure is positioned in the support structure and has a one-way gas circulation function, so that gas from the far end of the support structure is allowed to be exhausted from the near end of the support structure from the inside of the support structure, and gas from the near end of the support structure is prevented from entering the far end of the support structure from the inside of the support structure. The invention is fixed at the preset position of the trachea through the supporting structure, and under the action of the one-way blocking structure, the external air is prevented from entering the swollen lung, and the residual air in the lung is allowed to be discharged out of the body, thereby realizing the purpose of slowing down or even solving COPD.

Description

Airway obstruction device

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an airway obstruction device.

Background

Chronic Obstructive Pulmonary Disease (COPD) is a chronic bronchitis and/or emphysema characterized by airflow obstruction that can further progress to the common chronic diseases of pulmonary heart disease and respiratory failure.

The disability rate and the fatality rate of COPD are high, and according to the statistical prediction of global disease burden research, the COPD is located at the 3 rd position of the global death reason in 2020 (respiratory disease division of Chinese medical society chronic obstructive pulmonary disease group, 2014). COPD has become the 3 rd most common chronic disease in China, the number of patients is close to 1 hundred million (Lozano et al, 2010), and the sample investigation of people over 40 years old in 7 areas in China by 9 large-scale comprehensive hospitals organized by highly-known respiratory disease experts, namely, the Tongshan institution nationwide has found that the incidence rate of COPD is up to 8.3% (Zhong et al, 2007). Statistical data show that respiratory diseases mainly including COPD account for the 4 th mortality rate of urban resident diseases in China, and the total death number of COPD in China accounts for 31.1 percent of the total death number of COPD in the whole world. The prominent features and core manifestations of COPD are persistent airflow limitation and airway obstruction, and airflow limitation is not fully reversible, usually progressive (GOLD Executive Committee, 2015; vogelneieretal, 2017), severely affecting the patient's lung function and motor ability. Meanwhile, COPD is difficult to eradicate in a short period, so that medical cost is increased, and the patients are easy to generate moods such as anxiety, depression and the like, so that the living quality of the patients is influenced.

In conclusion, COPD is an important public health problem in today's society due to its large number of patients, high fatality rate and heavy social and economic burden. However, no drugs or devices are currently on the market that effectively address COPD.

Disclosure of Invention

The invention aims at solving the technical problem that the prior art lacks an apparatus for effectively solving COPD, and aims to provide an airway obstruction device.

An airway obstruction device includes a support structure that is hollow inside and has gas flow passages communicating with the outside at both proximal and distal end faces;

a one-way blocking structure located within the support structure and having a one-way gas flow function allowing gas from the distal end of the support structure to exit the proximal end of the support structure from within the support structure and preventing gas from the proximal end of the support structure from entering the distal end of the support structure from within the support structure.

When the invention is used, the airway obstruction device is arranged in a preset position, such as the interior of a trachea, external air is prevented from entering a swollen lung under the action of the one-way obstruction structure, and residual air in the lung is allowed to be discharged out of the body, so that the COPD problem is relieved.

The one-way blocking structure is preferably disposed within the proximal end of the support structure;

the cross-sectional diameter of the proximal end of the support structure is not less than the cross-sectional diameter of the rest of the support structure.

The support structure includes:

the first supporting part is hollow, the end faces of the near end and the far end are open structures, and the one-way blocking structure is arranged in the first supporting part;

the second supporting part is hollow inside, the near end and the far end face of the second supporting part are of an open structure and are symmetrically connected with the first supporting part, and the near end is communicated with the far end of the first supporting part.

The first supporting part and the second supporting part both adopt cone structures, and the vertex of the first supporting part is connected with and communicated with the vertex of the second supporting part.

The diameters of the bottom surfaces of the first supporting part and the second supporting part are both 1 mm-30 mm.

The first supporting part and the second supporting part are both of grid-shaped structures manufactured in a cutting or welding mode.

The first supporting part and the second supporting part are made of contractible self-expansion materials, preferably nickel-titanium alloy materials.

A first sealing film is arranged on the inner side wall of the first supporting part and is fixedly connected with the first supporting part in one or more modes of sewing, bonding or anchoring;

the first supporting part is fixedly connected with the one-way blocking structure through the first sealing film.

At least the near end of the first supporting part is further provided with a skirt edge, one end of the skirt edge is fixedly connected with the inner side wall of the first supporting part, and the other end of the skirt edge crosses the near end of the first supporting part, is folded and then is fixed on the outer side wall of the first supporting part.

And a second sealing film is arranged on at least one side wall on the inner side wall or the outer side wall of the second supporting part and is fixedly connected with the second supporting part in one or more modes of sewing, bonding or anchoring.

The thickness of the first sealing film and the thickness of the second sealing film are both 0.01-1 mm, and the first sealing film and the second sealing film are made of one or more of PET, polyurethane, PTFE and e-PTPE.

The support structure further comprises:

and the connecting pipe is arranged between the first supporting part and the second supporting part and connects and communicates the first supporting part and the second supporting part.

The diameter of the connecting pipe is 0.1 mm-0.5 mm, and the height of the connecting pipe is 1 mm-15 mm.

The support structure further comprises:

a plurality of developing members disposed at least at a distal end of the support structure.

The developing piece is made of an alloy material, and the alloy material is platinum, iridium or tantalum.

The one-way blocking structure adopts a valve body, the valve body includes a plurality of valve leaflets, a plurality of valve leaflets connect gradually and form the outer circumference for the ring structure the valve body, the valve body with bearing structure's inside wall fixed connection, the middle part of the valve body can one-way open and shut.

Each of the leaflets comprises:

the outer side of the valve leaf tail part is provided with a protruding structure, and the outer side edge of the protruding structure is connected with the inner side wall of the supporting structure;

the outer side of the sealing strip is connected with the inner side of the valve leaflet tail part, the side surface of the inner side of the sealing strip is perpendicular to the plane of the valve leaflet tail part, the other two opposite side surfaces of the sealing strip are respectively provided with a fixed end, and the fixed ends are turned over and wrapped with clamping pieces to form a fixing piece;

two adjacent valve leaflets are sequentially connected through the fixing piece to form the valve body, and the end parts of the inner side surfaces of the sealing strips in the two adjacent valve leaflets are contacted to realize that the middle parts of the valve body can be opened and closed in a one-way mode.

The outer edge of the tail part of the valve leaflet is provided with a sewing covering film or a valve leaflet sealing film so as to improve the strength of the valve leaflet and prevent the valve leaflet from being torn.

The thickness of the valve leaf is 0.05mm-0.1mm, and the valve leaf is made of one or more of high polymer materials, bovine pericardium, porcine pericardium or porcine heart valve.

The airway obstruction device further comprises:

and the anchoring elements are arranged on the outer side wall of the supporting structure, and the supporting structure is fixedly connected with the tracheal wall by the anchoring elements.

The anchoring element is made of any one or more of a polymer material or a metal material.

The positive progress effects of the invention are as follows: the invention adopts the airway obstruction device, is fixed at the preset position of the trachea through the supporting structure, avoids external air from entering the swollen lung under the action of the one-way obstruction structure, allows residual air in the lung to be discharged out of the body, and realizes the purpose of slowing down or even solving COPD.

Drawings

FIG. 1 is a schematic structural diagram of the present invention;

FIG. 2 is another schematic structural view of the present invention;

FIG. 3 is a top view of the present invention;

FIG. 4 is a schematic structural view of a unidirectional obstruction feature of the present invention;

FIG. 5 is a schematic view of a single leaflet of the present invention;

FIG. 6 is a schematic view of a clip according to the present invention;

fig. 7 is a schematic view of the relative positions of the clip and leaflet of the present invention;

FIG. 8 is a diagram of a delivery process of the present invention;

FIG. 9 is a release process diagram of the present invention;

fig. 10 is a state diagram of an application of the present invention.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific drawings.

Referring to fig. 1-3, an airway obstruction device includes a support structure 100, a unidirectional obstruction structure 200, and a number of anchors 300.

The support structure 100 is hollow inside, and the support structure 100 has an air flow passage from the proximal end to the distal end inside. The cross-sectional diameter of the proximal end of support structure 100 is not less than the cross-sectional diameter of the rest of support structure 100. The support structure 100 includes a first support 110, a first sealing film 120, a second support 130, a second sealing film 140, a connecting tube 150, and a plurality of developing members 160.

The first supporting part 110 is hollow, and a one-way blocking structure 200 is disposed in the first supporting part 110. The first sealing film 120 is disposed on the inner sidewall of the first support 110, and the first sealing film 120 is fixedly connected to the first support 110 by one or more of sewing, bonding, and anchoring. The first support part 110 is fixedly coupled to the one-way blocking structure 200 by the first sealing film 120. At least the proximal end of the first support portion 110 is further provided with a skirt, one end of the skirt is fixedly connected with the inner side wall of the first support portion 110, the other end of the skirt crosses the proximal end of the first support portion 110 and is fixed on the outer side wall of the first support portion 110 after being folded, and the skirt covers the proximal end of the first support portion 110.

The second supporting portion 130 is hollow, the second supporting portion 130 is symmetrically connected to the first supporting portion 110, and a proximal end of the second supporting portion 130 is communicated with a distal end of the first supporting portion 110. A second sealing film 140 is disposed on at least one of the inner side wall and the outer side wall of the second support 130, and the second sealing film 140 is fixedly connected to the second support 130 by one or more of sewing, bonding, and anchoring.

The thicknesses of the first sealing film 120 and the second sealing film 140 are both 0.01 mm-1 mm, and the materials of the first sealing film 120 and the second sealing film 140 are one or more of PET, polyurethane, PTFE and e-PTPE.

Referring to fig. 1 and 2, the first and

second support parts

110 and 130 each have a cone structure, and the vertex of the first support part 110 and the vertex of the second support part 130 are connected and communicated with each other. The diameters of the bottom surfaces of the first supporting part 110 and the second supporting part 130 are both 1mm to 30 mm. The first and

second support portions

110 and 130 are each a grid-like structure made by cutting or welding. The first support portion 110 and the second support portion 130 are made of shrinkable self-expandable material, preferably nickel-titanium alloy material.

The first support part 110 and the second support part 130 may be connected using a connection pipe 150 when they are connected. The connection pipe 150 is disposed between the first support part 110 and the second support part 130, and the first support part 110 and the second support part 130 are connected and communicated by the connection pipe 150. As shown in fig. 2, the vertex of the first support part 110 of the cone structure is connected to and communicated with one end of the connection pipe 150, and the vertex of the second support part 130 of the cone structure is connected to and communicated with the other end of the connection pipe 150. The diameter of the connection pipe 150 is 0.1mm to 0.5mm, and the height of the connection pipe 150 is 1mm to 15 mm.

A developer member 160 is provided at least at the distal end of the support structure 100. It is preferable that one developing member 160 is symmetrically disposed at both ends of the bottom surface of the first supporting part 110, and one developing member 160 is symmetrically disposed at both ends of the bottom surface of the second supporting part 130. The developing member 160 of the first supporting part 110 and the developing member 160 of the second supporting part 130 are symmetrically disposed at upper and lower ends thereof. The developing member 160 is made of an alloy material, and the alloy material is platinum, iridium or tantalum.

The one-way blocking structure 200 is located inside the support structure 100, preferably inside the first support 110. The one-way blocking structure 200 has a one-way gas flow function, allowing gas from the distal end of the support structure 100 to exit the proximal end of the support structure 100 from the interior of the support structure 100, and preventing gas from the proximal end of the support structure 100 from entering the distal end of the support structure 100 from the interior of the support structure 100.

Referring to fig. 4 to 7, the one-way blocking structure 200 is a valve body, the valve body includes a plurality of valve leaflets 210, the plurality of valve leaflets 210 are sequentially connected to form a valve body having a circular ring structure at an outer circumference, the valve body is fixedly connected to an inner sidewall of the support structure 100, and if a sealing film is disposed on the inner sidewall of the support structure 100, the valve body is fixedly connected to the inner sidewall of the support structure 100 through the sealing film. If the first sealing film 120 is disposed on the inner sidewall of the first support part 110 of the support structure 100, the valve body is fixedly connected to the inner sidewall of the first support part 110 through the first sealing film 120. The middle part of the valve body can be opened and closed in a one-way, has the function similar to a one-way valve and realizes the function of one-way gas circulation.

Each leaflet 210 has a thickness of 0.05mm-0.1mm, and each leaflet 210 is made of one or a combination of polymer material, bovine pericardium, porcine pericardium or porcine heart valve. Each leaflet 210 includes a leaflet tail 211, a sealing strip 212, and a securing member 213.

The outer side of the leaflet tails 211 is a ledge structure, the outer edge of which is connected to the inner side wall of the support structure 100. The edge of the structure protruding outside the leaflet tail 211 is provided with a sewing film or leaflet sealing film 2111 to improve the strength of the leaflet 210 against tearing. In fixedly attaching the valve body to the inner sidewall of the support structure 100, the sealing membrane 2111 may be fixedly attached to the inner sidewall of the support structure 100 by suturing.

The sealing strip 212 is of a bent structure, the outer side of the sealing strip 212 is connected with the inner side of the leaflet tail 211, the side where the inner side of the sealing strip 212 is located is perpendicular to the plane where the leaflet tail 211 is located, the other two opposite sides of the sealing strip 212 are respectively provided with a fixed end 2121, and the fixed end 2121 is folded and wrapped with a clip 214 to form a fixing member 213. As shown in fig. 5, the leaflet 210 is shown in an unfolded state with the sealing strip 212, and fixing ends 2121 are formed by extending outward from both left and right sides of the sealing strip 212. As shown in fig. 6, the thickness of the clip 214 is preferably 0.1mm to 0.5mm, and at least one clip sewing hole 2141 is formed on the clip 214, and the fixing end 2121 is sewn through the clip sewing hole 2141 and wraps the clip 214. Two adjacent valve leaflets 210 are connected in sequence through the fixing piece 213 and the clip suture hole 2141 by suture to form a valve body, and the inner side end parts of the sealing strips 212 in the two adjacent valve leaflets 210 are contacted to realize that the middle parts of the valve body can be opened and closed in one direction.

A plurality of anchors 300 are disposed on the outer sidewall of the support structure 100, and the anchors 300 are used to fixedly connect the support structure 100 to the tracheal wall. The anchor 300 is made of one or more of a polymer material and a metal material. As shown in fig. 1 to 3, a circle of the anchors 300 is uniformly disposed on the bottom outer side wall of the first support part 110, and a circle of the anchors 300 is uniformly disposed on the bottom outer side wall of the second support part 130. The anchor 300 is a cone structure, the bottom surface of the anchor 300 is fixed to the outer sidewall of the supporting structure 100, and the apex of the anchor 300 faces outward.

In use of the invention, referring to fig. 8, the airway obstruction device 500 of the invention is received within the inner tube of the delivery system 400 by the external delivery system 400, a puncture is made at a predetermined location on the body surface and the delivery system 400 with the airway obstruction device 500 is inserted into the trachea 600. referring to fig. 9, the inner tube of the delivery system 400 is pulled back at the appropriate location to release the airway obstruction device 500 and finally removed from the delivery system 400. Referring to fig. 10, the support structure 100 is fixed in the trachea 600, and prevents external air from entering the swollen lungs and allows residual air in the lungs to be discharged out of the body by the one-way blocking structure 200, in order to alleviate the COPD problem.

The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. An airway obstruction device comprising a support structure, wherein the support structure is hollow in its interior and has gas flow passages communicating with the exterior at both the proximal and distal end faces;

2. The airway obstruction device of claim 1, wherein the unidirectional obstruction feature is disposed within a proximal end of the support structure;

3. The airway obstruction device of claim 1, wherein the support structure comprises:

4. The airway obstruction device of claim 3, wherein the first support and the second support each have a conical configuration, the apex of the first support being interconnected and in communication with the apex of the second support;

the diameters of the bottom surfaces of the first supporting part and the second supporting part are both 1 mm-30 mm;

the first supporting part and the second supporting part are both of grid-shaped structures manufactured in a cutting or welding mode;

the first supporting part and the second supporting part are made of contractible self-expansion materials.

5. The airway obstruction device of claim 3, wherein the inner side wall of the first support is provided with a first sealing membrane that is fixedly attached to the first support by one or more of stitching, adhesive or anchoring;

the first supporting part is fixedly connected with the one-way blocking structure through the first sealing film;

at least the near end of the first supporting part is also provided with a skirt edge, one end of the skirt edge is fixedly connected with the inner side wall of the first supporting part, and the other end of the skirt edge crosses the near end of the first supporting part, is folded and then is fixed on the outer side wall of the first supporting part;

6. The airway obstruction device of claim 3, wherein the support structure further comprises:

7. The airway obstruction device of claim 1, wherein the support structure further comprises:

a plurality of developing members disposed at least at a distal end of the support structure;

the developing piece is made of alloy materials.

8. The device according to any of claims 1-7, wherein said one-way blocking structure comprises a valve body, said valve body comprises a plurality of valve leaflets, said plurality of valve leaflets are sequentially connected to form said valve body with an outer circumference of a circular ring structure, said valve body is fixedly connected with the inner side wall of said supporting structure, and the middle of said valve body can be opened and closed in one way;

each of the leaflets comprises:

9. The device of claim 8, wherein the outer edges of the valve leaflet tails are provided with a suture coating or a leaflet sealing membrane to increase the strength of the valve leaflets against tearing;

10. The airway obstruction device of any one of claims 1 to 7, further comprising: