Intratracheal one-way valve device and suction cleaning system using same

Abstract

The invention relates to the technical field of medical instruments, and provides an intratracheal one-way valve device and a suction cleaning system using the same. Comprising a support assembly and a one-way valve assembly. The support assembly is provided with a supporting part and a protection part. The one-way valve assembly is provided with a main valve, the main valve is provided with a supporting slope in an extending mode, and an auxiliary valve is arranged on the supporting slope. Wherein the window of the auxiliary valve is arranged on the supporting slope surface, the covering film of the auxiliary valve is attached to the outer slope surface of the supporting slope surface, and the end, away from the main valve, of the covering film is connected with the supporting slope surface. The one-way valve device has the advantages that during normal breathing, the auxiliary valve is in a closed state, the main valve is closed to prevent external air from entering the target lung during inspiration and is opened to discharge gas or secretions in the target lung during expiration, and during cough, the auxiliary valve is opened to discharge secretions deposited in the one-way valve device in the trachea; meanwhile, rapid exhaust air flow is formed to impact secretions outside the duckbilled main valve, and cleaning of the secretions around the main valve is facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an intratracheal one-way valve device and a suction and cleaning system using the same. Background Art

[0002] Chronic obstructive pulmonary disease is characterized by high morbidity and mortality, usually including chronic bronchitis and obstructive emphysema, and is mainly manifested as irreversible chronic airway obstruction and lung hyperinflation, and pathological lung parenchyma is manifested as emphysema. Currently, the method of transbronchial lung volume reduction is widely studied. A one-way valve is placed in the target area. Its working principle is to use a one-way valve to prevent external air from entering the emphysema area, while allowing the residual gas or secretions in the emphysema area to be discharged through the one-way valve, that is, the one-way valve is used to limit the ventilation of the lung tissue in the emphysema area, causing the lung tissue in the emphysema area to collapse, thereby achieving the effect of alleviating lung disease.

[0003] At present, most bronchial one-way valves used in clinical practice are duckbill-shaped one-way valves. However, the opening area of ​​the duckbill-shaped one-way valve is limited, and secretions are prone to accumulation, which can block the valve orifice and render it ineffective. It cannot achieve the therapeutic effect of lung volume reduction and may even cause obstructive pneumonia, aggravating the patient's condition. Surgery is required to remove the one-way valve and replace it with a new one-way valve, which undoubtedly increases the patient's pain and economic burden. Summary of the invention

[0004] The purpose of the present invention is to provide an intratracheal one-way valve device and a suction cleaning system using the same, so as to solve the problem that the existing duckbill one-way valve fails to function due to accumulation of secretions and clogging of the valve port.

[0005] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: an intratracheal one-way flap device, comprising: a support assembly and a one-way flap assembly;

[0006] The support assembly is provided with a supporting portion and a protecting portion, wherein the supporting portion is used to fix the one-way flap device, and the protecting portion is used to protect the one-way flap assembly;

[0007] The one-way flap assembly is provided with a main valve, the main valve is extended to provide a support slope, and the support slope is provided with a secondary valve; wherein,

[0008] The window of the secondary valve is arranged on the supporting slope, the cover film of the secondary valve is attached to the outer slope of the supporting slope, and one end of the cover film away from the main valve is connected to the supporting slope.

[0009] In an optional embodiment, the supporting portion and the protecting portion are connected via a connecting portion, the supporting portion and the protecting portion are both hollow tubular structures, and the protecting portion surrounds the one-way valve assembly.

[0010] In an optional embodiment, the supporting portion, the protecting portion and the connecting portion are all made of nickel-titanium alloy.

[0011] In an optional embodiment, the number of windows of the secondary valve is one or more, and the outer shape of the cover membrane is the same as the shape of the windows.

[0012] In an optional embodiment, the window shape of the secondary valve is square or circular.

[0013] In an optional embodiment, the window shape of the secondary valve is an equilateral triangle or a trapezoid; wherein an axis of the equilateral triangle is perpendicular to the projection of the intersection line between the main valve and the supporting slope, and one side of the equilateral triangle is parallel to the projection of the intersection line between the main valve and the supporting slope; the long side of the trapezoid is parallel to the projection of the intersection line between the main valve and the supporting slope.

[0014] In an optional embodiment, the window shape of the secondary valve is composed of a first arc segment, a second arc segment, a first arc-shaped segment and a second arc segment, wherein the first arc segment is arranged opposite to the second arc segment, the diameter of the first arc segment is larger than the diameter of the second arc segment; the first arc-shaped segment and the second arc segment are arranged in a mirror image; and there is a smooth transition between adjacent arc segments.

[0015] In an optional embodiment, the cover film includes a distal bending section, an intermediate bending section and a proximal bending section, and the distal bending section is connected to the supporting slope; wherein the hardness of the intermediate bending section is greater than the hardness of the distal bending section, and the hardness of the distal bending section is greater than the hardness of the proximal bending section.

[0016] In an optional embodiment, a plurality of circular dot grooves are evenly arranged on the inner side of the distal bending section.

[0017] On the other hand, the present invention also provides a suction and cleaning system, using the endotracheal one-way valve device as described above, comprising: an endotracheal treatment catheter, wherein the syringe of the endotracheal treatment catheter is connected to the insertion tube body.

[0018] The beneficial effects of the present invention are:

[0019] (1) The one-way valve device contains a duckbill-shaped main valve and a secondary valve. During normal breathing, the secondary valve is in a closed state. The main valve is closed during inhalation to prevent external air from entering the target lung, and is opened during exhalation to discharge gas or secretions in the target lung. During coughing, the secondary valve opens to discharge secretions accumulated in the one-way valve device in the trachea, and at the same time, a rapid exhaust airflow is formed to impact the secretions outside the duckbill-shaped main valve, which helps to clear the secretions around the main valve. In addition, the one-way valve assembly avoids the problem of increasing the exhaust flow rate compared to a single duckbill-shaped valve due to the addition of a secondary valve, which causes the emphysematous tissue to collapse rapidly and cause complications such as pneumothorax.

[0020] (2) The secondary valve of the one-way valve device can be forced to open, and a catheter can be used to inject normal saline into the bronchus distal to the one-way valve device through the secondary valve window to suction and clean the secretions at the distal end of the bronchus, or to inject therapeutic or anti-inflammatory drugs to reduce the production of secretions or dissolve the secretions, thereby avoiding the need to remove the one-way valve for treatment or replace the one-way valve due to excessive secretions, thereby reducing the patient's surgical pain and economic burden.

[0021] (3) The secondary valve window of the one-way flap device can be set in an equilateral triangle or trapezoid, etc., and can be set in a multi-arc segment window structure, in which the diameter of the first arc segment is larger than the diameter of the second arc segment; the first arc segment and the second arc segment are set in a mirror image; there is a smooth transition between adjacent arc segments. In the process of secretions or airflow impacting upward, due to the small area at the distal end and the large area at the proximal end, it is easier to discharge secretions or increase the exhaust flow rate when the window area is constant. It should be pointed out that the hardness of the middle bending section of the cover film is greater than the hardness of the distal bending section, and the hardness of the distal bending section is greater than the hardness of the proximal bending section. When the cover film is subjected to force, the proximal end is easier to open, and the circular dot groove of the distal bending section can increase the force between the secretions or airflow and the cover film, so that the distal bending section opens at a larger angle, further increasing the secretion or exhaust flow rate.

[0022] (4) The one-way valve device contains a secondary valve. During normal breathing, the secondary valve is in a closed state. During coughing, the secondary valve opens. Coughing generates a rapid airflow that passes through the main valve and the secondary valve to discharge and release pressure, thereby preventing the one-way valve from shifting or falling off due to a sharp increase in pressure at the far end of the one-way valve due to the one-way valve not being able to release pressure in time. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1The figure is a diagram of the structure of an intratracheal one-way valve device and its working principle during normal breathing provided in one embodiment of the present invention.

[0025] Figure 2 This is the open state of the one-way valve assembly during coughing provided in one embodiment of the present invention.

[0026] Figure 3 Schematic diagram of a one-way valve device in the bronchus provided in one embodiment of the present invention for clearing secretions during coughing.

[0027] Figure 4 This is a schematic diagram of an intratracheal treatment catheter provided in one embodiment of the present invention.

[0028] Figure 5 This is a schematic diagram of an endotracheal treatment catheter provided in one embodiment of the present invention for cleaning or treatment through a secondary valve.

[0029] Figure 6 It is a schematic diagram of the structure of a one-way valve assembly provided in one embodiment of the present invention.

[0030] Figure 7 It is a projection diagram of a trapezoidal window structure provided in one embodiment of the present invention.

[0031] Figure 8 It is a projection diagram of an equilateral triangle window structure provided in one embodiment of the present invention.

[0032] Fig. 9 It is a projection diagram of a multi-arc-segment window structure provided in one embodiment of the present invention.

[0033] Fig.10 It is a projection diagram of a cover film structure provided in one embodiment of the present invention.

[0034] Wherein, the accompanying drawings are marked as follows:

[0035] 1-stent assembly, 2-protection part, 3-connection part; 4-support part, 5-one-way valve assembly, 6-main valve (duckbill valve), 7-support slope, 8-auxiliary valve, 9-cover membrane, 10-bronchial wall, 11-secretions, 12-endotracheal treatment catheter, 13-syringe, 14-two-way valve, 15-insertion tube body, 16-insertion tube body head end, 17 cleaning fluid or treatment substance.

[0036] 81 is a window, 811 is a first arc segment, 812 is a second arc segment, 813 is a first arc segment, 814 is a second arc segment; 911 is a distal bending segment, 912 is a middle bending segment, and 913 is a proximal bending segment. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0038] It should be noted that when a component is referred to as being "fixed on" or "disposed on" another component, it may be directly or indirectly located on the other component. When a component is referred to as being "connected to" another component, it may be directly or indirectly connected to the other component. The directions or positions indicated by the terms "upper", "lower", "left", "right", "front", "back", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. are based on the directions or positions shown in the accompanying drawings and are only for the convenience of description and cannot be understood as limitations on the present technical solution. The terms "first" and "second" are only used for the convenience of description and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. "Multiple" means two or more, unless otherwise clearly and specifically defined.

[0039] Embodiment 1

[0040] Please see attached Figure 1-6 The purpose of this embodiment is to provide an intratracheal one-way valve device, including a stent assembly and a one-way valve assembly. The stent assembly is made of nickel-titanium alloy. The nickel-titanium alloy tube is laser cut and then heat-formed to form the stent assembly, or the nickel-titanium alloy wire is laser welded to form a super-elastic stent assembly with shape memory function.

[0041] Among them, the stent assembly includes a protective part, a connecting part and a supporting part. The protective part and the supporting part of the stent assembly are both hollow tubular structures, and the connecting part is a linear structure connecting the protective part and the supporting part. The protective part surrounds the one-way valve assembly, and the diameter of the protective part is smaller than the diameter of the trachea into which it is implanted, so as to prevent the one-way valve assembly from being squeezed and deformed and failing in function. The diameter of the supporting part is larger than the diameter of the trachea into which it is implanted, and the radial compression force generated by the compression of the supporting part fixes the one-way valve device in the trachea to the inner wall of the bronchus, so as to prevent the one-way valve device in the trachea from shifting. The connecting part connects the protective part and the supporting part, and the stent assembly is integrally coated. The one-way valve assembly is located inside the protective part and is integrally connected to the stent assembly coating. The coating and the one-way valve assembly of the stent assembly are both made of silicone rubber, including the main valve and the auxiliary valve. The main valve is a duckbill valve, the valve mouth length of the duckbill valve is 50% of the inner diameter of the protective part, and the thickness of the main valve lip is 50μm.

[0042] During normal breathing, the main valve has a one-way ventilation function that closes during inhalation to prevent outside air from entering the target lung, and opens during exhalation to expel gas or secretions from the target lung. A square window is opened on the supporting slope of the duckbill valve, and the window area is 1 / 2 of the single-side supporting slope area of ​​the duckbill valve. The window is covered with a square cover membrane with a thickness of 100μm. The area of ​​the auxiliary valve cover membrane is 1.5 times the window area.

[0043] In this embodiment, the window and the cover film constitute the secondary valve, the opening pressure of the main valve is the expiratory airflow pressure when a person breathes normally, and the opening pressure of the secondary valve is the expiratory airflow pressure when a person coughs; during normal breathing, the secondary valve is in a closed state, and the external air cannot enter the target lung, and the gas in the target lung cannot be discharged. The secondary valve is opened only when coughing or forced to open. In addition, the one-way valve assembly is prevented from causing complications such as pneumothorax due to the increase of the exhaust flow rate compared to a single duckbill valve due to the addition of the secondary valve. When coughing, the opening of the secondary valve can discharge the secretions accumulated in the one-way valve device in the trachea, and at the same time, a rapid exhaust airflow is formed to impact the secretions outside the duckbill main valve, which helps to clean the secretions around the main valve.

[0044] in addition

[0045] Embodiment 2

[0046] The purpose of this embodiment is to provide an intratracheal one-way valve device, the integral coating of the stent assembly and the one-way valve assembly are made of polyurethane, including a main valve and a secondary valve. The main valve is a duckbill valve, the length of the duckbill valve orifice is 90% of the inner diameter of the protection part, the thickness of the main valve lip is 200μm, the support slope of the duckbill valve has two circular windows, the window area is 2 / 3 of the single-side support slope area of ​​the duckbill valve, the window is covered with a circular cover film, the cover film thickness is 1000μm, and the area of ​​the secondary valve cover film is 1.2 times the window area. The rest of the structure is the same as that of the first embodiment.

[0047] In addition, in a preferred embodiment, the secondary valve can be forced to open, and the endotracheal treatment catheter can be used to inject cleaning liquid into the bronchus at the distal end of the endotracheal one-way flap device through the secondary valve window, to aspirate and clean the secretions at the distal end of the bronchus, or to inject therapeutic drugs to reduce the production of secretions or eliminate secretions. The suction treatment catheter includes a syringe, a connector and an insertion tube body. The syringe is a 5ml conventional syringe, which is used to inject cleaning liquid (such as saline) or therapeutic drugs, or to aspirate the mixed liquid after cleaning. The connector is a conventional Luer two-way valve, which connects the syringe and the insertion tube body to open or close the passage between the two. The insertion tube body is polyether block polyamide, with a length of 1000mm and a diameter not exceeding the inner diameter of the bronchoscope, and can be passed through the bronchoscope to the target lung. The head end of the insertion tube body is conical, and the diameter does not exceed the minimum diameter of the secondary valve window of the endotracheal one-way flap device, and can pass through the secondary valve window of the endotracheal one-way flap device. The side of the head end of the insertion tube body contains 4 microholes for injecting and spraying cleaning liquid (such as saline) or therapeutic drugs.

[0048] Please see attached Figure 7-8 In a preferred embodiment, the window 81 of the secondary valve is in the shape of an equilateral triangle or a trapezoid; wherein one axis of the equilateral triangle is perpendicular to the intersection projection of the main valve and the supporting slope, and one side of the equilateral triangle is parallel to the intersection projection of the main valve and the supporting slope; the long side of the trapezoid is parallel to the intersection projection of the main valve and the supporting slope. In the process of secretions or airflow impacting upward, since the distal area is small and the proximal area is large, it is easier to discharge secretions or increase exhaust flow when the window area is constant.

[0049] Please see attached Fig. 9 In a preferred embodiment, the window shape of the secondary valve is composed of a first arc segment 811, a second arc segment 812, a first arc segment 813 and a second arc segment 814, wherein the first arc segment 811 and the second arc segment 812 are arranged opposite to each other, the diameter of the first arc segment 811 is larger than the diameter of the second arc segment 812; the first arc segment 813 and the second arc segment 814 are arranged in a mirror image; there is a smooth transition between adjacent arc segments, the diameters of the above two arc segments are different, and the diameters of the two arc segments are also different from the diameter of the arc segment. Compared with the window design of a trapezoid or an equilateral triangle, the design method of a small distal area and a large proximal area is still adopted, but due to the design of the arc segment, the arc segment and the smooth transition segment, the appearance of edges and corners is avoided, and it is easier to discharge secretions or increase the exhaust flow.

[0050] Please note that please refer to the attached Fig.10In an optional embodiment, the cover film 9 includes a distal bending section 911, an intermediate bending section 912 and a proximal bending section 913, and the distal bending section 911, the intermediate bending section 912 and the proximal bending section 913 are all flexible but have different hardnesses. The distal bending section 911 is connected to the supporting slope; wherein, the hardness of the intermediate bending section 912 is greater than the hardness of the distal bending section 911, and the hardness of the distal bending section 911 is greater than the hardness of the proximal bending section 913. When the cover film is subjected to force, the proximal end is easier to open because the hardness of the proximal bending section 913 is the smallest. The circular dot groove of the distal bending section 911 can increase the force between the secretion or airflow and the cover film, so that the distal bending section 911 opens at a larger angle, further increasing the secretion or exhaust flow rate. Since the hardness of the distal bending section 911 is centered, the distal bending section 911 will not bend too much when subjected to force. At the same time, the middle bending section 912 has a relatively high hardness and a certain curvature after being subjected to force. The curvature is smaller than that of the distal bending section 911 and the proximal bending section 913. It is a slope with a certain curvature, which is conducive to the sliding discharge of secretions or airflow.

[0051] Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An intratracheal one-way valve device, characterized in that: include: A bracket assembly and a one-way flap assembly; The support assembly is provided with a supporting portion and a protecting portion, the supporting portion is used to fix the one-way flap device, and the protecting portion is used to protect the one-way flap assembly; The one-way flap assembly is provided with a main valve, the main valve is extended to provide a support slope, and the support slope is provided with a secondary valve; wherein, The window of the secondary valve is arranged on the supporting slope, the cover film of the secondary valve is attached to the outer slope of the supporting slope, and one end of the cover film away from the main valve is connected to the supporting slope.

2. The endotracheal one-way valve device according to claim 1, characterized in that: The supporting portion and the protecting portion are connected via a connecting portion. Both the supporting portion and the protecting portion are hollow tubular structures, and the protecting portion surrounds the one-way valve assembly.

3. The endotracheal one-way valve device according to claim 1, characterized in that: The supporting portion, the protecting portion and the connecting portion are all made of nickel-titanium alloy.

4. The endotracheal one-way valve device according to claim 1, characterized in that: The number of the windows of the secondary valve is one or more, and the outer shape of the cover film is the same as the shape of the windows.

5. The endotracheal one-way valve device according to claim 1, characterized in that: The window shape of the secondary valve is square or circular.

6. The endotracheal one-way valve device according to claim 1, characterized in that: The window shape of the secondary valve is an equilateral triangle or a trapezoid; wherein, an axis of the equilateral triangle is perpendicular to the projection of the intersection line between the main valve and the supporting slope, and one side of the equilateral triangle is parallel to the projection of the intersection line between the main valve and the supporting slope; the long side of the trapezoid is parallel to the projection of the intersection line between the main valve and the supporting slope.

7. The endotracheal one-way valve device according to claim 1, characterized in that: The window shape of the secondary valve is composed of a first arc segment, a second arc segment, a first arc-shaped segment and a second arc segment, wherein the first arc segment is arranged opposite to the second arc segment, the diameter of the first arc segment is larger than the diameter of the second arc segment; the first arc-shaped segment and the second arc segment are arranged in a mirror image; and there is a smooth transition between adjacent arc segments.

8. The endotracheal one-way valve device according to claim 7, characterized in that: The cover film includes a distal bending section, an intermediate bending section and a proximal bending section, wherein the distal bending section is connected to the supporting slope; wherein the hardness of the intermediate bending section is greater than that of the distal bending section, and the hardness of the distal bending section is greater than that of the proximal bending section.

9. The endotracheal one-way valve device according to claim 8, characterized in that: A plurality of circular dot grooves are evenly arranged on the inner side of the distal bending section.

10. A suction cleaning system, using the endotracheal one-way valve device according to any one of claims 1 to 9, characterized in that: include: An endotracheal treatment catheter having a syringe connected to a tube body.

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