A one-way valve device for lung treatment

Abstract

This invention discloses a one-way valve device for lung treatment, comprising: a tubular frame and wheel-shaped structures disposed at both ends of the frame; a portion of the outer surface of the frame is covered with a sealing membrane, and the other portion is covered with a microporous membrane; it also includes: an umbrella structure, which works in conjunction with the frame. During exhalation, the umbrella structure opens to expel gas, and during inhalation, the umbrella structure locks into place with the frame to prevent air intake, thereby achieving one-way ventilation. Simultaneously, the proximal end of the frame is entirely open, providing a large outlet for the smooth discharge of secretions. The upper part of the frame is covered with a complete sealing membrane for sealing, while the lower part is covered with a microporous membrane, allowing mucosal cilia to pass through the micropores and facilitating the discharge of secretions from the frame. Before secretions accumulate in the frame, the wheel strips divide the secretions, making smaller secretions easier for the mucosal cilia within the frame to transport. During coughing, the airflow causes the secretions to impact the wheel strips, breaking them up and facilitating their discharge.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a one-way valve device for lung treatment. Background Technology

[0002] To reduce trauma to patients during surgery for chronic obstructive pulmonary diseases such as emphysema and bullae, the current approach is to use bronchoscopy to intervene in the bronchial valve.

[0003] There are two types of bronchial valves: the duckbill bronchial valve (EBV) and the umbrella bronchial valve (IBV). Both of them work by using a one-way valve to prevent outside air from entering the emphysema area, while allowing residual gas or secretions in the emphysema area to be discharged through the one-way valve. In other words, by restricting the ventilation of the lung tissue in the emphysema area through the one-way valve, the lung tissue in the emphysema area collapses, thereby achieving the effect of relieving lung disease.

[0004] From a clinical perspective, EBV still presents with airflow obstruction issues such as pneumothorax and secretion stasis. This is primarily because the duckbill-shaped valve opening of the EBV is located far from the distal end of the covered stent, preventing the mucosal cilia on the bronchial wall from naturally draining secretions through back-and-forth movement. Additionally, the limited width of the duckbill-shaped valve easily leads to secretion accumulation. After IBV implantation in the bronchus, secretions from the emphysematous region drain from distal to proximal along the narrow gap between the proximal surface of the septum and the bronchial wall. However, the proximal end of the umbrella-shaped stent has multiple points of contact with the bronchial wall, easily causing mucosal tissue hyperplasia around the stent endpoints, forming granulomas that block the gap between the septum and the bronchial wall, further hindering secretion drainage. Summary of the Invention

[0005] In view of this, the present invention provides a one-way valve device for lung treatment to solve the technical problems of difficulty in draining bronchial valve secretions, which easily leads to stagnation and blockage. To provide a basic understanding of some aspects of the disclosed embodiments, a brief summary is given below. This summary is not intended as a general commentary, nor is it intended to identify key / important components or describe the scope of protection of these embodiments. Its sole purpose is to present some concepts in a simple form as a prelude to the detailed description that follows.

[0006] The present invention adopts the following technical solution:

[0007] In one embodiment, the present invention provides a one-way valve device for lung treatment, comprising: a tubular frame and a wheel-shaped structure disposed in the openings at both ends of the frame; a portion of the outer surface of the frame is covered with a sealing membrane and another portion is covered with a microporous membrane.

[0008] In one embodiment, the pores formed on the microporous membrane have a diameter of 0.5 to 10 μm.

[0009] In one embodiment, the wheel-shaped structure includes: a perforated ring and a plurality of wheel strips surrounding the perforated ring in a radiating pattern; the perforated ring is located at the axial position of the tube openings at both ends of the frame; one end of each wheel strip is connected to the perforated ring, and the other end is connected to the frame.

[0010] In one embodiment, the unidirectional valve device for lung treatment further includes: an umbrella structure; the umbrella structure includes: a connecting wire and a plurality of first support wires disposed at one end of the connecting wire, the first support wires being covered with a first circular membrane to form an umbrella, the umbrella being arc-shaped and bent toward one side of the frame.

[0011] In one embodiment, the umbrella structure further includes: a plurality of second support wires disposed at the other end of the connecting wire, the second support wires being covered with a second circular membrane to form a limiting piece; the connecting wires passing through the perforated rings of the wheel-shaped structure at both ends of the frame, the umbrella being located outside the proximal end face of the frame and fastened to the frame, and the limiting piece being located outside the perforated rings of the wheel-shaped structure on the distal end face.

[0012] In one embodiment, the frame is bent towards the axis at both ends; the diameter of the middle part of the frame is 7-12mm, the diameter of the two end faces is 50-90% of the diameter of the middle part, and the length of the frame is 8-15mm; wherein, the bending angle of the two ends of the frame towards the axis is 40-80°.

[0013] In one embodiment, the number of wheel strips in each wheel-shaped structure is 3 to 6, and the diameter of the perforated ring is 0.1 to 1 mm.

[0014] In one embodiment, the number of the first support wire and the second support wire are 3 to 10 respectively; the length of the first support wire is 70 to 90% of the radius of the end face of the frame; and the length of the second support wire is 1.5 to 2 times the radius of the hole ring.

[0015] In one embodiment, the frame is a self-expanding support.

[0016] In one embodiment, the frame, wheel-shaped structure, connecting wire, first support wire, and second support wire are made of nickel-titanium alloy; the sealing membrane, microporous membrane, first circular membrane, and second circular membrane are made of silicone rubber or polyurethane.

[0017] The beneficial effects of this invention are as follows:

[0018] 1. It has a one-way ventilation function. During exhalation, the gas flows from the distal end to the proximal end of the frame, opens the outer edge of the umbrella cover, and the gas is discharged. During inhalation, the gas flows from the outside of the proximal end of the frame to the proximal end, presses the umbrella cover, and prevents the gas from the proximal end from entering the distal end. At the same time, the proximal end of the frame is fully open and has a large discharge outlet, which is conducive to the smooth discharge of secretions.

[0019] 2. The upper part of the frame is covered with a complete sealing film to seal it, while the lower part is covered with a microporous membrane. Mucosal cilia can move through the micropores, which is conducive to the discharge of secretions from the frame.

[0020] 3. The upper and lower ends of the frame are equipped with wheel-shaped structures. Before secretions accumulate in the frame, the wheel strips can divide the secretions. Smaller secretions are easier for the mucosal cilia inside the frame to transport. When coughing, the airflow causes the secretions to hit the wheel strips and break them up, making them easier to expel. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the external structure of the unidirectional valve device of the present invention;

[0023] Figure 2 This is a schematic diagram of the internal structure of the unidirectional valve device of the present invention;

[0024] Figure 3 This is a schematic diagram of the wheel-shaped structure of the present invention;

[0025] Figure 4 This is a schematic diagram of the umbrella cover of the present invention;

[0026] Figure 5 This is a schematic diagram of the limiting piece of the present invention. Detailed Implementation

[0027] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the described embodiments are merely some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0028] In some illustrative embodiments, such as Figure 1-5As shown, the present invention provides a one-way valve device for lung treatment, comprising: a frame 1, a wheel-shaped structure 2, a sealing membrane 3, a microporous membrane 4, and an umbrella-shaped structure 5.

[0029] The frame 1 is a tubular structure and a self-expanding stent, formed by the intersection of different columns. It is implanted into the trachea via a pressure-grip delivery tube and self-expands after release of fixation. The tubular structure design provides both support and ensures that breathing and the drainage of secretions are not affected after implantation. To clearly show the location and connection method of other structures in the one-way valve device, Figure 2 The specific column structure is not shown, but it is clear that the frame 1 formed by the intersection of different columns can adopt any existing column intersection form, as long as it serves a supporting function.

[0030] Two wheel-shaped structures 2 are respectively installed inside the openings at both ends of the frame 1. These structures not only divide and break up secretions, improving the smoothness of large-volume secretion discharge, but also hold the umbrella cap in place, allowing it to engage with the frame 1 for one-way ventilation. Specifically, the wheel-shaped structure 2 includes: a perforated ring 201 and several wheel strips 202 radiating around the perforated ring 201; the perforated ring 201 is located at the axial position of the openings at both ends of the frame 1; one end of each wheel strip 202 is connected to the perforated ring 201, and the other end is connected to the frame 1. Specifically, both ends of the wheel strips 202 are laser-welded to the frame 1 and the perforated ring 201. The above structural design can effectively separate large volumes of secretions when they pass through, while also ensuring the stability of the frame 1 structure. In addition, the wheel-shaped structure 2 can match the pipe opening design of the frame 1, directly using the pipe opening of the frame 1 as the secretion discharge outlet. The pipe opening size is large (no other structure occupies the pipe opening position), which can improve the smoothness of discharge. Combined with the wheel-shaped structure 2, secretions can be discharged quickly and smoothly, avoiding accumulation and blockage.

[0031] The diameter of the perforated ring 201 is 0.1–1 mm. The thickness of the perforated ring 201 is negligible compared to its diameter; therefore, the diameter value can refer to either the inner or outer diameter. Each wheel-shaped structure 2 contains 3–6 wheel strips 202. Within the above-mentioned range, the wheel strips and perforated ring ensure sufficient support while avoiding obstruction of the passage and affecting the discharge of secretions. The number of wheel strips on the upper and lower end faces of the frame can be the same or different.

[0032] One part of the outer surface of the frame 1 is covered with a sealing film 3, and the other part is covered with a microporous membrane 4, such as Figure 1As shown, the upper part of the outer surface of the stent is covered with a complete sealing membrane 3 for sealing, and the lower part is covered with a microporous membrane 4. The microporous membrane 4 has micropores to facilitate the movement of bronchial mucosal cilia through the micropores, which is conducive to the discharge of secretions from the stent. Preferably, the pore diameter of the microporous membrane 4 is 0.5 to 10 μm. Within this range, it can be avoided that the pores are too large, causing granulation tissue to form and squeeze in, thereby blocking the internal cavity of the stent and affecting the movement of secretions. It can also be avoided that the pore diameter is too small, preventing the mucosal cilia from entering smoothly.

[0033] The umbrella structure 5 includes: a connecting wire 501, a plurality of first support wires 502, a first circular membrane 503, a plurality of second support wires 504, and a second circular membrane 505.

[0034] The first support wire 502 is located at one end of the connecting wire 501 and is arranged in a radiating pattern. A first circular membrane 503 is covered on the first support wire 502 to form an umbrella canopy. The first circular membrane 503 can be compared to the umbrella surface, and the first support wire 502 can be compared to the umbrella ribs. The second support wire 504 is located at the other end of the connecting wire 501 and is also arranged in a radiating pattern. A second circular membrane 505 is covered on the second support wire 504 to form a limiting piece. The umbrella canopy is arc-shaped and bends towards the frame 1, i.e., it fastens towards the frame 1. The limiting piece is planar.

[0035] Connecting wire 501 passes through the perforated rings 201 at both ends of the frame 1. The canopy is located outside the proximal end face of the frame and fastens to the frame 1. The limiting piece is located outside the perforated ring 201 of the wheel-shaped structure on the distal end face. The connecting wire 501 restrains the canopy and prevents it from detaching from the frame 1. The proximal end face of the frame refers to the end closer to the oral cavity, and the distal end face refers to the end farther from the oral cavity. This structural design achieves unidirectional ventilation. The canopy and the upper frame with sealing membrane 3 are interlocked to achieve a sealing effect. During exhalation, gas flows from the distal end to the proximal end of the frame, opening the outer perimeter of the canopy and expelling the gas. During inhalation, gas flows from the outside of the proximal end of the frame to the proximal end, and the airflow presses against the canopy, causing the canopy to tightly fasten to the upper frame with sealing membrane 3, preventing gas from entering the distal end. It not only achieves a better sealing effect, but also has a stable structure and reasonable layout. With the tubular frame design, it can ensure forward exhalation and prevent reverse air intake without affecting the discharge of secretions. Moreover, the umbrella design can leave a large proximal opening for the frame, so that the proximal end of the frame can be fully opened and has a large discharge outlet, which is more conducive to the smooth discharge of secretions.

[0036] The frame 1 is bent at both ends towards the axis. This configuration facilitates the forming of a wheel-shaped structure on the end face, which then supports the umbrella cover. This configuration makes the frame more stable and easier to form. The bending angle of the two ends of the frame 1 towards the axis is 40-80° to further ensure stability. The diameter of the middle part of the frame 1 is 7-12mm, and the diameter of the two end faces is 50-90% of the diameter of the middle part. The length of the frame 1 is 8-15mm. The thickness of the frame 1 is negligible compared to the diameter, so the diameter value can refer to either the inner or outer diameter. The unidirectional valve device of this invention is used in the human bronchus and must meet the bronchus size requirements. After compression implantation and release, the middle part of the frame 1 supports the bronchus to prevent the device from shifting or falling off. Therefore, the diameter of the middle part of the heat-set frame must be larger than the diameter of the bronchus. After compression implantation and release, the middle part of the frame 1 is in a slightly compressed or semi-compressed state, and there is a radial extension force between the middle part of the frame 1 and the bronchus. The length value is set to ensure that the contact area with the bronchus is large enough after implantation, so that it can be stabilized and not fall off.

[0037] The number of first support wires 502 and second support wires 504 are 3 to 10 respectively. The length of the first support wire 502 is 70% to 90% of the radius of the end face of the frame 1; the length of the second support wire 504 is 1.5 to 2 times the radius of the perforated ring 201. The first support wires 502 and the second support wires 504 are used to support the first circular membrane 503 and the second circular membrane 505. Therefore, setting them within the above-mentioned range can ensure sufficient support force, prevent detachment and damage, and avoid excessive number or excessive length, which would lead to structural imbalance and difficulty in opening the ventilation during exhalation.

[0038] The frame 1, wheel-shaped structure 2, connecting wire 501, first support wire 502, and second support wire 504 are made of nickel-titanium alloy. Nickel-titanium alloy is a shape memory alloy, a special alloy that can automatically restore its original shape after plastic deformation at a specific temperature. It has good plasticity and also has excellent characteristics such as wear resistance, corrosion resistance, high damping, and superelasticity. The sealing membrane 3, microporous membrane 4, first circular membrane 503, and second circular membrane 505 are made of silicone rubber or polyurethane, which has the advantages of good biocompatibility and good plasticity.

[0039] Because the overlap length between the first circular membrane 503 and the bending surface of the frame 1 is too short to provide a seal, air leaks at this point during inhalation; if it is too long, it is difficult to open during exhalation. Therefore, the overlap length between the first circular membrane 503 and the bending surface of the frame 1 in this invention is 0.1–2 mm. The radius of the second circular membrane 505 is slightly larger than the length of the second support wire.

[0040] In practical use, the frame 1 is first compressed and implanted. Then, the compressed umbrella structure 5 is passed through the annular holes 201 at both ends of the frame 1 and gradually released, so that the limiting plate is located outside the lower annular hole 201 and the umbrella is located outside the upper annular hole 201. This device has a one-way ventilation function, allowing gas from the distal end to be discharged while preventing gas from the proximal end from entering the distal end. It also has a large exhaust port. The various structural designs work together to facilitate the smooth discharge of secretions, providing a discharge aid function and reducing secretion accumulation.

[0041] The upper and lower ends of the frame are equipped with wheel-shaped structures. Before secretions accumulate in the frame, the wheel strips can separate the secretions. Smaller secretions are easier for the mucosal cilia inside the frame to transport. When coughing, the airflow causes the secretions to hit the wheel strips and break them up, making them easier to expel.

[0042] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A one-way valve device for lung treatment, characterized in that, include: A tubular frame and wheel-shaped structures disposed within the openings at both ends of the frame; The wheel-shaped structure includes: a perforated ring and a plurality of wheel strips surrounding the perforated ring in a radiating pattern; the perforated ring is located at the axial center of the tube openings at both ends of the frame; one end of each wheel strip is connected to the perforated ring, and the other end is connected to the frame. One part of the outer surface of the frame is covered with a sealing membrane, and the other part is covered with a microporous membrane, wherein the pores in the microporous membrane have a diameter of 0.5~10μm; It also includes: an umbrella structure; the umbrella structure includes: a connecting wire and a plurality of first support wires disposed at one end of the connecting wire, the first support wires being covered with a first circular film to form an umbrella, the umbrella being arc-shaped and bent toward one side of the frame; the umbrella structure also includes: a plurality of second support wires disposed at the other end of the connecting wire, the second support wires being covered with a second circular film to form a limiting piece. The connecting wire passes through the perforated rings of the wheel-shaped structure at both ends of the frame, the umbrella cover is located outside the near end face of the frame and fastens to the frame, and the limiting piece is located outside the perforated rings of the wheel-shaped structure on the far end face.

2. The one-way valve device for lung treatment according to claim 1, characterized in that, The frame is bent towards the axis at both ends; the diameter of the middle part of the frame is 7~12mm, the diameter of the two end faces is 50~90% of the diameter of the middle part, and the length of the frame is 8~15mm; wherein, the bending angle of the two ends of the frame towards the axis is 40~80°.

3. The one-way valve device for lung treatment according to claim 2, characterized in that, The number of wheel strips in each wheel-shaped structure is 3 to 6, and the diameter of the perforated ring is 0.1 to 1 mm.

4. The one-way valve device for lung treatment according to claim 3, characterized in that, The number of the first support wire and the second support wire are 3 to 10 respectively; the length of the first support wire is 70 to 90% of the radius of the end face of the frame; the length of the second support wire is 1.5 to 2 times the radius of the hole ring.

5. A one-way valve device for lung treatment according to claim 4, characterized in that, The frame is a self-expanding support.

6. A one-way valve device for lung treatment according to claim 5, characterized in that, The frame, wheel-shaped structure, connecting wire, first support wire, and second support wire are made of nickel-titanium alloy; the sealing membrane, microporous membrane, first circular membrane, and second circular membrane are made of silicone rubber or polyurethane.

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