Suction pressure-regulating valve device and system

Abstract

[Problem] To more easily reduce discomfort to a patient and make it possible to safely and effectively suction an object to be suctioned in a minimally invasive manner. [Solution] A suction pressure-regulating valve device 100 that is connected between a suction hose of a suction device and a ventilation member worn on the body and regulates the suction pressure for suctioning an object to be suctioned from the body, the suction pressure-regulating valve device 100 comprising: a cylindrical body section 102; a first connection section 104 that is provided to a first cylindrical end section 102a of the body section and is for connection to the suction hose; a cylindrical second connection section 106 that is provided to a second cylindrical end section 102b of the body section; and a valve mechanism 110 that is provided to a side surface 102c of the body section and regulates the suction pressure by opening when the suction pressure reaches or exceeds a predetermined level. The second connection section is connected to either an intake mask worn on the body or a suction object guide tube for guiding an object to be suctioned inside the trachea of the body to the upper airway side by means of the suction pressure from the suction device.

Description

Suction pressure regulating valve device and system

[0001] The present disclosure relates to suction pressure regulating valve devices and systems.

[0002] In medical or nursing care settings, suction catheters or other devices connected to the suction tube (suction hose) of a suction device are used to aspirate and remove suction-target substances from the human body, such as sputum, saliva, and nasal mucus that have accumulated in the pharynx due to aging or illness. When using a suction catheter to aspirate sputum or other substances from a living body's respiratory system, sufficient suction effect cannot be achieved unless the tip (suction port) of the suction catheter reaches the substance. Furthermore, if the suction catheter is inserted into the lower respiratory tract to achieve the suction effect, there is a risk of damaging the airway.

[0003] As a related technology for efficiently performing sputum suction, for example, Patent Document 1 discloses a collection device that performs mechanical insufflation-exsufflation (hereinafter referred to as MI-E) by mechanically applying positive pressure and then negative pressure to the patient's lungs to guide sputum in the lungs to the upper respiratory tract and then aspirate and collect it with a suction catheter. Furthermore, Patent Document 2 discloses a suction object guide tube that, when connected to the suction tube (suction hose) of a suction device, more easily guides the suction object to the patient's upper respiratory tract, enabling minimally invasive suction of the suction object.

[0004] However, conventional suction catheter techniques have fundamental physical limitations. Because the catheter tip is not sealed within the airway, suction pressure is wasted on drawing in the surrounding air, which offers less resistance, rather than on the more viscous secretions that are the target of removal. This "air-short-circuit" effect makes it extremely difficult to effectively remove secretions from peripheral airways that are physically inaccessible to the catheter. This problem remains unresolved even with closed suction catheters.

[0005] JP-T-2013-524202 A (specification paragraph

[0017] ) JP-A-2022-015559

[0006] However, simply adjusting the suction pressure is not enough to overcome the limitations of conventional techniques due to the aforementioned "air short-circuit" effect. Therefore, there is a need for a technology based on a new principle that can convert "unsuctionable" secretions accumulated in the peripheral airways into a "suctionable" state, reduce the discomfort to patients and the risk of airway damage caused by excessive suction pressure, and safely and effectively remove aspirated material.

[0007] The present disclosure has been made in consideration of the above-mentioned problems, and aims to more easily reduce discomfort to the patient and enable minimally invasive suction of the object to be suctioned safely and effectively.

[0008] One aspect of the present disclosure is a suction pressure adjustment valve device that is connected between a suction hose of a suction device and a body-worn ventilation member to adjust the suction pressure for suctioning an object to be suctioned from a living body, and includes a cylindrical main body, a first connection portion provided at a first cylindrical end of the main body for connection to the suction hose, a cylindrical second connection portion provided at a second cylindrical end of the main body, and a valve mechanism that is provided on a side of the main body and opens to adjust the suction pressure when the suction pressure reaches or exceeds a predetermined level.

[0009] According to one aspect of the present disclosure, a suction object guide tube is attached to the tip of a suction hose of a suction device via a suction pressure adjustment valve device, and the suction pressure adjustment valve device adjusts the suction pressure to an appropriate level, thereby reducing discomfort to the patient caused by excessive suction pressure. Therefore, the suction pressure adjustment valve device enables safe and efficient minimally invasive suction of the object to be suctioned. Furthermore, the suction pressure adjustment device allows for easy adjustment of the suction pressure, thereby easily reducing discomfort to the patient.

[0010] Another aspect of the present disclosure is a system for adjusting the suction pressure for sucking an object to be aspirated from a living body, comprising: a suction device provided with a suction hose; the above-mentioned suction pressure adjustment valve device connected between the suction hose and a ventilation member to be worn on the human body; and a suction object guide tube connected to a second connection part of the suction pressure adjustment valve device, which guides the object to be aspirated in the trachea of ​​the living body toward the upper respiratory tract by the suction pressure from the suction device.

[0011] According to another aspect of the present disclosure, a suction device includes a suction pressure adjusting valve device that connects a suction object guide tube to the tip of the suction hose of the suction device, and the suction object guide tube is then tightly attached to the body-worn ventilation member to communicate with the suction device. The suction pressure adjusting valve device then guides the object in the trachea toward the upper respiratory tract. The suction pressure adjusting valve device adjusts the suction pressure to an appropriate level, thereby reducing the discomfort felt by the patient due to excessive suction pressure. This system therefore enables safe, effective, and minimally invasive suction of the object.

[0012] According to an embodiment of the present disclosure, a suction pressure adjusting device, system, and method for guiding an aspirated object using the same safely utilize a new physiological principle known as "vacuum-induced lung compression" by sealing the airway or a body-worn ventilation element and applying continuous negative pressure. This gently compresses the entire lung parenchyma, effectively squeezing secretions in the peripheral airways, which are inaccessible to conventional catheter aspiration, into the upper airway. As a result, previously "unaspirated" secretions are transformed into "aspirated" secretions, reducing patient discomfort and enabling safe and effective minimally invasive aspiration of aspirated objects. As an example, in a preclinical pig model, a suction method based on one embodiment of the principles of the present invention was confirmed to achieve an excellent clearance rate of 81.3 mm / s on average, compared to 0 mm / s using conventional aspiration methods.

[0013] According to one aspect of the present disclosure, it is possible to reduce the discomfort felt by the patient due to excessive suction pressure, and to perform minimally invasive suction of the object to be suctioned safely and effectively.

[0014] FIG. 1 is a perspective view of a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 2 is a cross-sectional view taken along line II-II of FIG. 1 . FIG. 3 is a side view of a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 4 is a plan view of a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 5 is a front view of a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 6 is a rear view of a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 7 is a cross-sectional view taken along line VIII-VIII of FIG. 7. FIG. 8 is a perspective view of an unused state of a suction object guide tube to which a suction pressure adjustment valve device according to an embodiment of the present disclosure is attached. FIG. 9 is a perspective view of an unfolded state of a suction object guide tube to which a suction pressure adjustment valve device according to an embodiment of the present disclosure is attached. FIG. 11 is a schematic configuration diagram of a system using a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 12 is a schematic configuration diagram of another embodiment of a system using a suction pressure adjustment valve device according to an embodiment of the present disclosure. FIG. 13 is a schematic configuration diagram of yet another embodiment of a system using a suction pressure adjustment valve device according to an embodiment of the present disclosure.

[0015] Preferred embodiments of the present disclosure will be described in detail below. Note that the embodiments described below do not unduly limit the content of the present disclosure described in the claims, and not all of the configurations described in the embodiments are necessarily essential as means for solving the problems of the present disclosure.

[0016] In the following description, terms indicating directions such as "upper," "lower," "left," and "right" are used for convenience of explanation and do not limit the method or manner of use. Terms such as "first" and "nth" (n is an integer) following "first" in this specification and claims are used as identifying terms to distinguish different elements and do not indicate a particular order or superiority or inferiority.

[0017] The terms used in the following description are for the purpose of describing particular embodiments only and are not intended to limit the scope of the present disclosure. Elements according to an aspect described in the specification and claims are intended to include the plural forms unless the context clearly dictates that they are singular or plural.

[0018] The term "and / or" is intended to refer to and include any and all possible combinations of one or more of the associated listed elements. For example, "A or B" means "A, B, or both A and B." "A," "B," and "both A and B" all individually satisfy "A or B."

[0019] The terms "includes," "including," "comprises," and "comprising" used in this specification and in the claims are intended to specify the presence of features, operations, elements, or steps, but do not exclude the presence or addition of one or more other features, operations, elements, steps, and / or groups thereof.

[0020] All embodiments and optional embodiments included in this disclosure may be combined with each other to form new embodiments, and all technical features and optional technical features included in this disclosure may be combined with each other to form new technical features.

[0021] All of the embodiments and optional embodiments included in this disclosure may be modified to form new embodiments or variations of the embodiments by omitting some of the components, substituting other components, or adding components, and the embodiments in this case may be formed as devices, systems, methods, etc.

[0022] Description of the suction pressure regulating valve device 100:

[0023] First, the schematic configuration of a suction pressure regulating valve device according to an embodiment of the present disclosure will be described with reference to the drawings: Fig. 1 is a perspective view of a suction pressure regulating valve device according to an embodiment of the present disclosure, Fig. 2 is a cross-sectional view taken along line II-II of Fig. 1, Fig. 3 is a side view, Fig. 4 is a plan view, Fig. 5 is a front view, and Fig. 6 is a rear view.

[0024] The suction pressure regulating valve apparatus 100 of this embodiment is a device for aspirating and removing suction targets, such as sputum, from a patient's respiratory system. That is, the suction pressure regulating valve apparatus 100 is connected between a suction device (a fixed or portable sputum suction device) and a body-worn ventilation member when aspirating and removing suction targets, such as sputum and other body fluids, from the patient's respiratory tract, including the lower respiratory tract.

[0025] Specifically, the suction pressure adjustment valve device 100 is attached to a suction hose (suction tube) connected to a suction device. The suction pressure adjustment valve device 100 can be attached to the tip of the suction hose, for example.

[0026] On the other hand, the suction pressure regulating valve device 100 is connected to a body-worn ventilation member. The suction pressure regulating valve device 100 and the body-worn ventilation member are connected directly or indirectly. The body-worn ventilation member may include an inhalation mask, a tracheal cannula, a tracheal tube, or the like.

[0027] The suction pressure adjusting valve device 100 has a base end connected to a suction object guide tube (described later) and has the function of adjusting the suction pressure when the suction object is guided to the upper airway by the suction pressure (negative pressure) generated by the suction device through the suction object guide tube. As shown in Figure 1, the suction pressure adjusting valve device 100 includes a main body 102, a first connecting portion 104, a second connecting portion 106, and a valve mechanism 110.

[0028] The main body 102 is a tube made of resin such as polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), ABS resin, or acrylic resin (PMMA). The main body 102 has a first connection part 104 at one end (first tube end) and a second connection part 106 at the other end (second tube end). The main body 102 has a valve mechanism 110 on its side.

[0029] The first connecting portion 104 is a tube made of the resin described above and is provided at the first tube end 102a, which is one end of the main body 102. Specifically, the first connecting portion 104 is formed as a tube that protrudes outward from the first tube end 102a of the main body 102 in the tube axis direction of the main body 102. The first connecting portion 104 and the main body 102 are arranged coaxially. As shown in FIG. 1 , the first connecting portion 104 has a shape that tapers in diameter from the base end on the main body 102 side toward the tip. It is configured to be connectable to a suction hose by fitting it onto one end of the suction hose. The tip of the first connecting portion 104 is an opening 104a. The inner diameter of the opening 104a is, for example, approximately 7.0 mm, but is not limited to this and may be other sizes. In this embodiment, the first connecting portion 104 has a shape that tapers in three stages toward the tip, but a shape that tapers in multiple stages other than the three stages illustrated may be used as long as it is a shape that tapers in diameter toward the tip to make it easier to fit onto one end of a suction hose. The multi-stage shape of the first connecting portion 104 makes it possible to connect to suction hoses with various inner diameters. Furthermore, the first connecting portion 104 is not limited to a shape that tapers in stages toward the tip as shown in FIG. 1 , but may also have a funnel shape that gradually narrows toward the tip.

[0030] The second connecting portion 106 is a tube made of the resin and is provided at the second tube end portion 102b, which is the other end of the main body portion 102. Specifically, the second connecting portion 106 is formed as a tube that protrudes outward from the second tube end portion 102b of the main body portion 102 in the tube axis direction of the main body portion 102. The second connecting portion 106 and the main body portion 102 are arranged coaxially. As shown in FIG. 1 , the second connecting portion 106 has a larger outer diameter than the main body portion 102. The outer diameter of the second connecting portion 106 is the same as the inner diameter of a connecting hole provided in the inhalation mask, which will be described later, so that the second connecting portion 106 can be fitted to the inhalation mask worn by the patient. Furthermore, the inner diameter of the second connecting portion 106 is the same as the outer diameter of the base end of a connecting portion provided in the inhalation mask, which will be described later, so that the second connecting portion 106 can be fitted to the inhalation mask. That is, the inner diameter of the base-end opening 106a of the second connecting portion 106 is the same as the outer diameter of the base-end side of the connecting portion of the object guide tube. Note that "same" as used in this specification and claims includes both "completely same" cases where the length and size are completely the same, and "substantially same" cases where the difference between the length and size of both is slight.

[0031] The valve mechanism 110 is provided on the side surface 102c of the main body 102. The valve mechanism 110 has the function of adjusting the internal pressure (suction pressure) of the object guide tube. Specifically, the valve remains closed until the suction pressure for guiding the object to the upper airway reaches a predetermined level, and opens when the suction pressure exceeds the predetermined level, thereby releasing the internal pressure of the object guide tube to the atmosphere. As shown in FIG. 2 , the valve mechanism 110 includes a valve chamber 111, a valve element 112, and a pressure spring 113.

[0032] As shown in Fig. 1, the valve chamber 111 has a thin, cylindrical configuration with a cylindrical side surface 111c. As shown in Fig. 2, the valve chamber 111 has a communication hole 111b1 in the bottom surface 111b that communicates with the opening hole 102a1 in the side surface 102c of the main body 102, and an intake hole 111a1 in the top surface 111a through which gas can flow. The diameters of the opening hole 102a1, the communication hole 111b1, and the intake hole 111a1 are the same as the inner diameter of the opening 104a of the first connecting part 104 to reduce the difference with the suction force transmitted from the suction device 10 and ensure stable suction operation.

[0033] As shown in FIG. 2 , the valve chamber 111 has a female thread 111c2 formed on the upper end side of the inner circumferential surface 111c1 of the side surface 111c. Furthermore, a male thread 111a3 that threads into the female thread 111c2 is formed on the lower surface of the top surface 111a near the outer edge of the top surface 111a. By configuring the valve chamber 111 of the valve mechanism 110 in this manner, the top surface 111a can rotate relative to the side surface 111c. Rotating the top surface 111a moves the top surface 111a toward or away from the bottom surface 111b, thereby changing the distance between the top surface 111a and the bottom surface 111b. The valve disc 112, which abuts against the top surface 111a, moves according to this distance, thereby functioning as an adjustment mechanism that can adjust the elastic force (biasing force) of the pressure spring 113 that presses the valve disc 112 to a desired magnitude. The elastic force (biasing force) exerted by the pressure spring 113 functions as a closing force that keeps the valve body 112 closing the intake hole 111a1 against the reduced pressure caused by suction.

[0034] The configuration of the adjustment mechanism that can adjust the elastic force (biasing force) of the pressure spring 113 to a desired magnitude is not limited to the above. That is, it can be configured by a preload adjustment mechanism that applies a closing force to the valve body 112. One example of such a preload adjustment mechanism is a rotation adjustment mechanism that is provided between the top surface 111a and the valve body 112 and converts the rotational movement of the top surface 111a into the vertical movement of the valve body 112, thereby adjusting the preload applied to the pressure spring 113. This allows the elastic force of the pressure spring 113 to be adjusted, thereby adjusting the valve-opening pressure of the valve body 112.

[0035] As shown in FIG. 1 , the outer edge of the top surface 111a is provided with scales 111a2, which serve as indicators for displaying the suction pressure at which the valve mechanism 110 opens in multiple stages. By rotating the top surface 111a so that one of the scales 111a2 aligns with a reference point 111d on the side surface 111c, the valve opening pressure of the valve mechanism 110 can be adjusted to the suction pressure indicated by the scale 111a2. The scale 111a2 may be in the form of graduated lines as shown in FIG. 1 , or may include numerical values ​​or only numerical values. The top surface 111a also has a vent groove 110a with a curved cross section that communicates with the intake hole 111a1 and reaches the outer edge of the top surface 111a. This prevents the intake hole 111a1 from being blocked even when the top surface 111a is placed on a flat surface or covered. As shown in FIGS. 3 to 6, the outer diameter of the valve chamber 111 is larger than the outer diameter of the second connecting portion 106 and is the same as the length of the main body portion 102 .

[0036] The valve element 112 is a disk-shaped member provided within the valve chamber 111, and has the function of opening and closing the intake hole 111a1 via the biasing force (elastic force) of the pressure spring 113. In a closed state, the valve element 112 blocks the intake hole 111a1 provided in the top surface 111a of the valve chamber 111. The valve element 112 is in a closed state when suction is not being applied. On the other hand, in an open state, the valve element 112 moves away from the intake hole 111a1 due to suction pressure transmitted from the main body 102 via a communication hole 111b1 provided in the bottom surface 111b of the valve chamber 111, thereby opening the intake hole 111a1.

[0037] An air gap 112b is formed between the outer edge 112a of the valve disc 112 and the inner circumferential surface 111c1 of the side surface 111c of the valve chamber 111. The air gap 112b is formed as a uniform gap between the outer edge 112a of the valve disc 112 and the inner circumferential surface 111c1 of the side surface 111c around the entire circumference of the valve disc 112. Because of the air gap 112b, the valve disc 112 does not come into contact with the inner circumferential surface 111c1 of the side surface 111c of the valve chamber 111 during displacement, allowing smooth opening and closing operations. Furthermore, by making the air gap 112b uniform around the entire circumference of the inner circumferential surface 111c1 of the side surface 111c, gas can escape to the air gap 112b evenly around the entire circumference of the valve disc 112, preventing the valve disc 112 from losing its posture during displacement due to uneven distribution of the gas passage. Therefore, when the valve body 112 opens relative to the intake port 111a1, it becomes easier to maintain a stable open state.

[0038] Furthermore, the valve element 112 has a disk shape significantly larger than the area of ​​the intake hole 111a1. Because of the difference in size with the intake hole 111a1, a pressure difference occurs between the opening and closing pressures of the valve element 112 of the valve mechanism 110. Therefore, by continuously applying suction pressure (negative pressure) from the suction device via the suction pressure adjustment valve device 100, air moves to the lungs as the negative pressure causes the lungs to collapse (contract), and the lungs (thorax) return to their original position as the pressure is released, resulting in a movement similar to artificial respiration. Therefore, by using the suction pressure adjustment valve device 100 to perform the suction operation of the object to be aspirated using the aspirated object guide tube, it is possible to perform minimal breathing when the valve mechanism 110 of the suction pressure adjustment valve device 100 is in the open state. In other words, the suction pressure adjustment valve device 100 can also function as an artificial respirator.

[0039] The pressure spring 113 functions as a "biasing member" that elastically biases the valve disc 112 in the valve chamber 111 toward the intake hole 111a1. In this embodiment, the pressure spring 113 is a compression coil spring formed by winding a wire material of a predetermined wire diameter, such as metal or hard resin, a predetermined number of times. The compression coil spring is merely an example of the pressure spring 113, and other pressure springs, such as leaf springs and disc springs, may also be used as long as they have the function of elastically biasing the valve disc 112 toward the intake hole 111a1. Furthermore, instead of a "spring" such as a pressure spring, an elastic member such as synthetic rubber may also be used. Both the pressure spring and the elastic member can constitute the "biasing member." The biasing member biases the valve element 112 to close the intake hole 111a1 under the action of a suction pressure that does not reach the valve opening pressure or when no suction pressure is applied (when an object to be sucked), and on the other hand, under the action of a suction pressure that is equal to or greater than the valve opening pressure (when air is being drawn in), it contracts, moving the valve element 112 away from the intake hole 111a1 and releasing the suction pressure, and further, under the action of a suction pressure that does not reach the valve opening pressure or when no suction pressure is applied (when an object to be sucked in), its restoring force automatically biases the valve element 112 to close the intake hole 111a1. In this way, the biasing member functions as a control member that mechanically and automatically operates the valve element (differential safety valve) using the gas pressure difference, without the need for an external power source or manual operation.

[0040] The valve mechanism 110 is configured such that when the magnitude of the suction pressure transmitted from the main body 102 via the communication hole 111b1 exceeds the magnitude of the biasing force of the pressure spring 113 on the valve body 112, the valve body 112 moves away from the intake hole 111a1 to open the intake hole 111a1. When performing vacuum suction to guide the suction target, such as sputum, to the upper respiratory tract, the airway pressure is set to -40 cmH to prevent excessive strain on the patient's lungs. ２ O or more -60cmH ２ It is preferable to perform suction so that the negative pressure is below 0. It is particularly important to note that in order to safely and effectively perform vacuum suction (vacuum suction) to guide sputum and other objects to be aspirated to the upper airway, the airway pressure should be kept at -60 cmH. ２ It is particularly preferable that the valve opening pressure of the valve mechanism 110 be set so as not to result in an excessive negative pressure exceeding 0 (approximately −6 kPa).

[0041] Therefore, the pressure spring 113 is set to the maximum suction pressure of -60 cmH. ２ The valve mechanism 110 is configured so that when a suction pressure having an absolute value greater than the negative pressure of O is applied to the valve element 112, the valve element 112 is pressed to open, with a spring constant such that the valve is opened. In this embodiment, the valve mechanism 110 adjusts the distance between the top surface 111a and the bottom surface 111b of the valve chamber 111 by rotating (pivoting) the top surface 111a, which is threadedly engaged with the upper end of the inner circumferential surface 111c1 of the side surface portion 111c. As the top surface 111a moves in the height direction, the valve element 112, which abuts against the top surface 111a, also moves, so that the elastic force due to the preload (resistance to suction pressure) of the pressure spring 113 that presses the valve element 112, can be adjusted to a desired magnitude.

[0042] In this embodiment, the elastic force of the pressure spring 113 is adjusted to a desired magnitude, thereby adjusting the biasing force transmitted to the valve element 112 via the pressure spring 113. This allows the valve opening pressure at which the valve element 112 opens the intake hole 111a1 to be adjusted to a desired magnitude. In this embodiment, the adjustment mechanism that adjusts the valve opening pressure of the valve element 112 by adjusting the elastic force of the pressure spring 113 includes a scale 111a2 on the surface of the top surface 111a, which serves as a display that displays the suction pressure that results in the desired valve opening pressure, as described above. Note that the display that displays the suction pressure that results in the valve opening pressure may be a display that visually displays the suction pressure or another display device that allows the suction pressure to be checked in real time, and may be configured in a manner other than the scale 111a2 on the surface of the top surface 111a.

[0043] With this configuration of the valve mechanism 110, when the suction pressure transmitted from the main body 102 through the communication hole 111b1 exceeds the maximum suction pressure set for each patient, the suction force acting on the valve body 112 due to the suction pressure becomes greater than the pressing force of the pressure spring 113 on the valve body 112. As a result, the valve body 112 moves away from the intake hole 111a1, opening the intake hole 111a1 and entering an open valve state. Note that the "maximum suction pressure" referred to in this specification and claims refers to the suction pressure at which the absolute value of the "maximum suction pressure," expressed as a negative pressure, is at its maximum. In other words, since the numerical value of the "maximum suction pressure" itself is a negative pressure (negative pressure), it indicates the minimum value of the suction pressure.

[0044] In the open state, outside air enters through the intake port 111a1 from which the valve element 112 is separated, and the airway pressure due to the suction pressure transmitted from the suction device via the suction pressure adjustment valve device 100 and the object guide tube 150 is reduced to a suction pressure lower than the maximum suction pressure. When the valve element 112 separates from the intake port 111a1 and opens, an operating sound can be heard to indicate that the valve element 112 has opened. Examples of operating sounds include the sound generated when gas flows through the suction path including the suction pressure adjustment valve device 100 during suction, the intake sound generated when outside air flows into the valve chamber 111 through the intake port 111a1 after the valve element 112 opens, the creaking sound generated when the compression spring 113 compresses, and the metallic sound generated when the wires of the compression spring 113 compress and come into contact with each other.

[0045] In particular, the operating sound (valve opening sound, suction sound from the intake port) generated when the valve mechanism opens serves as a clear acoustic cue to the surgeon indicating that lung collapse, i.e., "vacuum-induced lung compression," is occurring effectively. This allows the surgeon to intuitively grasp the appropriate end point of the procedure and prevent excessive suction. This function is extremely important for ensuring the standardization and safety of the procedure, regardless of the surgeon's level of expertise, and greatly contributes to the de-skilling of the procedure.

[0046] Furthermore, the intake port 111a1 is exposed to the outside of the suction pressure adjustment valve device 100. Therefore, by partially or completely blocking the intake port 111a1 with a finger or other device, a medical professional can intentionally restrict or block the inflow of outside air through the intake port 111a1, thereby applying a greater negative pressure. This allows, for example, the suction of more viscous materials such as sputum to be achieved. In this way, the suction pressure for aspirating the material to be aspirated can be varied not only by the suction pressure of the valve body 112, which is set for each patient, but also by the auxiliary suction pressure generated by manually partially or completely blocking the intake port 111a1. This allows for flexible adjustments at the medical professional's discretion depending on the patient's accumulated sputum, etc. Furthermore, no electrical drive source is required for this.

[0047] As described above, in this embodiment, the valve mechanism 110 is configured to open and close the valve element 112. That is, when the suction pressure is equal to or greater than a predetermined level in a closed state, the valve mechanism automatically opens mechanically without using an electrical drive source. Furthermore, when the suction pressure is lower than a predetermined level in an open state, the valve mechanism automatically closes mechanically without using an electrical drive source. Therefore, the suction pressure regulating valve device 100 has a simple structure that does not require an electrical drive source to open and close the valve element 112. However, when the suction pressure exceeds the valve-opening pressure due to the repulsive force of the pressure spring 113, the valve element 112 moves toward the bottom surface 111b of the valve chamber 111 against the pressing force of the pressure spring 113, thereby automatically and smoothly opening the valve.

[0048] This prevents excessive suction pressure from being applied during sputum suction. Furthermore, when the valve mechanism 110 opens, the valve opening can be easily recognized by the sound of suction, etc. Therefore, by setting the time after the valve opens to a predetermined time, anyone can easily and accurately perform the suction operation for sputum suction, regardless of the size of the patient's lungs. Furthermore, by easily recognizing the open state when excessive suction pressure is applied, the collapsed state of the lungs can be reliably detected, thereby ensuring minimally invasive sputum suction treatment with reduced burden and pain for the patient. The valve mechanism 110 is not limited to the configuration shown in FIG. 2 and may be configured in other ways, such as by including a pressure relief valve, a vacuum relief valve, or other mechanism that can limit the suction pressure when the set suction pressure is exceeded.

[0049] Description of the object guide tube 150:

[0050] Next, the schematic configuration of a sucked object guide pipe connected to a suction pressure adjustment valve device according to an embodiment of the present disclosure will be described with reference to the drawings. Fig. 7 is a perspective view showing a state in which a sucked object guide pipe connected to a suction pressure adjustment valve device according to an embodiment of the present disclosure is in use, Fig. 8 is a cross-sectional view taken along line VIII-VIII of Fig. 7, Fig. 9 is a perspective view showing the sucked object guide pipe in an unused state, and Fig. 10 is a perspective view showing the sucked object guide pipe in an unfolded state.

[0051] The object guide tube 150 is attached to the tip of a suction hose connected to a suction device via the suction pressure adjustment valve device 100 of this embodiment when suctioning and removing objects to be aspirated, such as sputum and other body fluids, from a patient's respiratory tract, including the lower respiratory tract. The object guide tube 150 is used as a member that guides the objects to be aspirated toward the upper respiratory tract by the suction force (negative pressure) of the suction device. As shown in Figure 7, the object guide tube 150 includes a guide tube main body 151, an inner cover 152, and a tip cap 153.

[0052] The guide tube main body 151 is provided on one surface with a connecting tube 151a that serves as a connector that can be connected to a suction hose or the suction pressure adjustment valve device 100 of this embodiment. Furthermore, the guide tube main body 151 has an opening 151a2 with an inner diameter of, for example, about 17 mm on the opposite side facing the connecting tube 151a, as shown in Fig. 8, and the inner circumferential surface 151b is a curved surface that continues toward the base end of the connecting tube 151a. As shown in Fig. 8, the inner circumferential surface 151b of the guide tube main body 151 is a gently curved surface that decreases in diameter from the opening 151a2 side toward the base end of the connecting tube 151a.

[0053] The connecting tube 151a of the guide tube main body 151 has a shape that tapers toward the tip, and the tip forms an opening 151a1. The inner diameter of the opening 151a1 is, for example, about 7.0 mm. Note that the shape of the connecting tube 151a need only be a shape that tapers toward the tip, and is not limited to a shape that tapers in stages toward the tip as shown in FIG.

[0054] 7, a holder 155 capable of holding a tubular member is provided at one end of the outer periphery of the lower end of the guide tube main body 151. For example, the tip of a suction hose of a suction device can be fixed upward as the tubular member held by the holder 155.

[0055] As shown in Fig. 9 , an inner lid 152, which introduces an object to be aspirated into the object guide tube 150, is provided on the guide tube main body 151 opposite the connecting tube 151a so as to be openable and closable via a hinge mechanism 156. As shown in Fig. 8 , the inner circumferential surface 152b of the inner lid 152 is curved so that its diameter decreases from the base end to the tip end. When the inner lid 152 is closed on the guide tube main body 151, the inner circumferential surface 152b is continuous with the inner circumferential surface 151b of the guide tube main body 151, forming a so-called olive-shaped space between the inner circumferential surfaces 152b of the inner lid 152 and 151b of the guide tube main body 151. The inner lid 152 has an opening 152a with an inner diameter of, for example, about 4.0 mm on the tip end, and the opening 120a of the inner lid 152 can be opened and closed by a tip cap 153 connected via a connecting cord 154 connected to one end of the inner lid 152.

[0056] When the aspirated object guide tube 150 is connected to a suction hose of a suction device for suctioning sputum or the like, the inner cover 152 is opened to the opening 151a2 of the guide tube main body 151 when suctioning sputum or the like in the respiratory tract. Next, the inner circumferential surface 151b of the guide tube main body 151 is brought close to and tightly attached to the end of a tracheal tube, tracheal cannula, or the like attached to the patient. This allows the suction force (negative pressure) from the suction device to perform vacuuming (guiding, vacuum suction) to move the aspirated object, such as sputum, in the lower respiratory tract from the trachea to the terminal bronchioles in the lungs toward the upper respiratory tract. After the object has been moved toward the upper respiratory tract, the suction object, such as sputum, guided toward the upper respiratory tract can then be aspirated using a suction device such as a suction catheter.

[0057] 7 and 8, when nasal mucus or the like is to be aspirated from the nasal cavity, the inner lid 152 covers the opening 151a2 of the guide tube main body 151, the tip cap 153 is removed from the opening 152a to open the opening 152a, and the opening 152a of the inner lid 152 is then brought close to the nasal cavity and tightly fitted. Then, the suction force from the suction device is used to perform vacuuming, which moves the mucus or other aspirated material to the front of the nasal cavity, so that the material can be aspirated and removed. Alternatively, the material moved to the front of the nasal cavity by vacuuming can be aspirated and removed by using a suction catheter or other suction tool.

[0058] On the other hand, when the object to be sucked guide tube 150 is not in use, in order to prevent the object to be sucked remaining in the suction hose from falling due to backflow and to prevent foreign matter such as dust from entering the object to be sucked guide tube 150, an inner lid 152 closes the opening 151a2 of the guide tube main body 151, and a tip cap 153 closes the opening 152a, forming a lid, as shown in FIG.

[0059] 10, the object guide tube 150 is configured as an integrally molded body, including a guide tube main body 151, an inner cover 152, a hinge mechanism 156, a tip cap 153, and a connection cord 154. That is, the object guide tube 150 is configured as an integrally molded body, with each component being injection-molded from a thermoplastic resin such as polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), ABS resin, or acrylic resin (PMMA).

[0060] System 1 Description:

[0061] Next, a system for adjusting the suction pressure for aspirating an object to be aspirated, which employs a suction pressure adjustment valve apparatus 100 according to an embodiment of the present disclosure, will be described with reference to the drawings. Fig. 11 is a perspective view of a body fluid suction device 200 in which a suction pressure adjustment valve apparatus according to an embodiment of the present disclosure is attached to a tube for guiding an object to be aspirated. Fig. 12 is a schematic diagram of a system using a body fluid suction device 200 including a suction pressure adjustment valve apparatus according to an embodiment of the present disclosure. Note that Fig. 12 illustrates the system of this embodiment, in which sputum is introduced as an object to be aspirated through a tracheal cannula (a ventilation member worn on the body) attached to a patient via tracheotomy, and then aspirated.

[0062] The system 1 of this embodiment is applied to adjust the suction pressure for sucking an object to be aspirated, such as sputum and other body fluids stuck in the trachea A1, which is the airway of a living patient P1, or in the lungs (not shown), etc. In the system 1, as shown in Figure 12, the suction pressure adjustment valve device 100 of this embodiment is interposed between the suction hose 12 of the suction device 10 and the object to be aspirated guide pipe 150, thereby making it possible to adjust the suction pressure for sucking the object to be aspirated.

[0063] To interpose the suction pressure adjustment valve apparatus 100 between the suction hose 12 and the object guide pipe 150, first, as shown in Figures 11 and 12, the connecting pipe 151a of the object guide pipe 150 is inserted into the second connecting part 106 of the suction pressure adjustment valve apparatus 100 to connect the suction pressure adjustment valve apparatus 100 to the object guide pipe 150. This completes the body fluid suction device 200. Then, as shown in Figure 12, the system 1 is constructed by inserting and connecting the first connecting part 104 of the suction pressure adjustment valve apparatus 100 to one end of the suction hose 12 of the suction apparatus 10.

[0064] The suction device 10 has a suction pump 14, which serves as a negative pressure source for generating suction pressure in a suction hose 12 made of a flexible resin such as polyurethane, and a storage section 16 for storing the object to be sucked through the suction hose 12. When a portable suction device is used as the suction device 10, the portable suction device can be connected to the object to be sucked via the suction pressure adjustment valve device 100 of this embodiment, in which case the suction hose 12 can be omitted. In addition, in the system 1 of this embodiment, the object to be sucked via the suction pressure adjustment valve device 100 is attached to one end of the suction hose 12, but the suction pressure adjustment valve device 100 and the object to be sucked via the suction hose 12 can also be configured such that they are integrated.

[0065] In this embodiment, for example, the inner cover 152 of the aspirated object guide tube 150 is opened relative to the guide tube main body 151, and then, as shown in Figure 12, the guide tube main body 151 is inserted into the incision A2 formed in the throat of the patient P1 and brought close to the tracheal cannula 20 fixed by the fixing plate 22 and the cuff 24. Then, the inner circumferential surface 151b of the guide tube main body 151 of the aspirated object guide tube 150 is brought into contact with one end 20a of the tracheal cannula 20, and the suction operation by the suction device 10 is started. In the system 1, the suction force (negative pressure) from the suction device 10 is transmitted to the tracheal cannula 20 via the suction pressure adjustment valve device 100 and the aspirated object guide tube 150, thereby performing vacuuming (induction, vacuum suction) to move the aspirated object, such as sputum, in the lower respiratory tract from the trachea A1 to the terminal bronchioles in the lungs toward the upper respiratory tract.

[0066] That is, in the system 1 and method of this embodiment, the aspirated object guide tube 150 connected to the suction hose 12 via the suction pressure adjustment valve device 100 is inserted into the incision A2 and brought into close contact with one end 20a of the tracheal cannula 20, thereby moving the aspirated object, such as sputum, aspirated from the tracheal cannula 20 toward the upper respiratory tract. Thereafter, the aspirated object, such as sputum, guided toward the upper respiratory tract in the trachea A1 is aspirated by the suction catheter.

[0067] In this embodiment, the diameter of the opening 151a2 of the aspirated object guide tube 150 is configured to be somewhat larger than the diameter of the one end 20a of the tracheal cannula 20 to provide some leeway. Specifically, for example, if the outer diameter of the one end 20a of the tracheal cannula 20 is φ15 mm, the inner diameter of the opening 151a2 of the aspirated object guide tube 150 is set to 17 mm, which makes it easier to bring the two components into close contact and prevents the patient from choking due to excessive contact, i.e., the connection of the two components.

[0068] As described above, in the system 1 of this embodiment, the aspirated object guide tube 150 performs vacuuming to move the aspirated object, such as sputum, in the lower respiratory tract from the trachea A1 to the terminal bronchiole toward the upper respiratory tract, and then aspirates the object moved into the trachea A1 toward the upper respiratory tract with a suction instrument such as a suction catheter. That is, the aspirated object guide tube 150 of the system 1 of this embodiment is used as an attachment that guides the aspirated object, such as sputum, in the lower respiratory tract from the trachea A1 to the terminal bronchiole toward the upper respiratory tract, making it easier to aspirate the object with a suction instrument such as a suction catheter.

[0069] Furthermore, in the system 1 of this embodiment, the suction pressure adjustment valve device 100 is interposed between the suction hose 12 of the suction device 10 and the suction object guide tube 150, which serves as an attachment for vacuuming. Therefore, when the negative suction pressure transmitted from the suction device 10 to the suction object guide tube 150 has an absolute value greater than the desired value, the valve mechanism 110 of the suction pressure adjustment valve device 100 opens to adjust the suction pressure so as to reduce the absolute value, thereby alleviating the discomfort felt by the patient due to excessive suction pressure and achieving safe and effective sputum suction.

[0070] Aspirate object guidance method, sputum suction method:

[0071] Next, as an application example of the method for adjusting the suction pressure for sucking an object to be aspirated according to this embodiment, a method for guiding an object to be aspirated while adjusting the suction pressure and a method for suctioning sputum using the above-mentioned system 1 will be described.

[0072] When aspirating sputum or other substances from the lower respiratory tract of the patient P1, first, the lungs of the patient P1 are auscultated with a stethoscope to check their condition, and then, for example, a bag valve mask is used to aspirate the sputum or other substances from the lower respiratory tract of the patient P1. ２ The lungs are inflated by pressurized ventilation with positive O pressure for 3 to 5 seconds. If the lungs are atelectatic distal to the location where the aspirated material is stored, there is no air in the peripheral lungs even when vacuuming is performed, making it difficult to squeeze the aspirated material toward the upper airway. Therefore, in this embodiment, pressurized ventilation is performed before the suction procedure.

[0073] Furthermore, when sputum suction is required, the patient P1's respiratory condition is often poor and their blood oxygen saturation is low. Therefore, during sputum suction, the patient P1 is likely to be unable to breathe and suffer from hypoxemia. Therefore, in this embodiment, when performing the pressurized ventilation described above before suctioning, oxygen is mixed in and pressurized ventilation is performed to stabilize the patient's condition, and then suctioning is initiated to improve atelectasis and oxygenate the patient. While high-concentration oxygen may be mixed into the pressurized ventilation to quickly stabilize the patient P1's condition, pressurized ventilation using normal air containing oxygen may also be used if short-term suction is not required. Furthermore, a pressurized ventilation device such as a bag valve mask may also be included in the system 1 of this embodiment.

[0074] Then, for example, -60 cmH ２ After collapsing the entire lung with a negative pressure of O, the suctioned material such as sputum is guided to the upper airway for 3 to 5 seconds, and then the suctioned material such as sputum guided to the upper airway is sucked and cleaned with a suction device such as a suction catheter. If the lung collapses due to the vacuum, it will become atelectatic, so the pressure is again reduced to 40 cmH. ２ By performing pressurized ventilation with a positive pressure of O for 3 to 5 seconds, the lungs return to a normal state where air is present. In this way, in the system 1 of this embodiment, pressurized ventilation is performed before and after the suction procedure, which is performed by contracting the entire lungs with negative pressure vacuuming.

[0075] In this embodiment, when performing vacuuming, for example, the set pressure of the suction device 10 (suction device) is −600 cmH. ２ O and maximum suction pressure -60cmH ２ When the absolute value of the suction pressure becomes greater than the negative pressure of O, the valve mechanism 110 of the suction pressure regulating valve device 100 is activated to open the valve element 112. In this way, opening the valve element 112 of the suction pressure regulating valve device 100 reduces the absolute value of the suction pressure that has become greater than the absolute value of the maximum suction pressure, thereby enabling reliable detection of a collapsed lung, thereby eliminating the risk of damaging the patient's airway and discomfort caused by suction with excessive suction pressure.

[0076] In this way, in the method of guiding the aspirated object using the system 1 of this embodiment, a cycle of auscultating the patient P1, followed by pressurized ventilation at positive pressure, vacuuming at negative pressure while adjusting the suction pressure, suctioning the aspirated object guided to the upper airway, then pressurized ventilation at positive pressure again, and checking the condition by auscultation is repeated until the symptoms of the patient P1 improve. Also, when performing vacuuming, if the suction pressure that becomes negative is excessively high and has an absolute value greater than the maximum suction pressure, the absolute value of the suction pressure is adjusted to reduce to the desired value.

[0077] That is, in the system 1 of this embodiment, the suction pressure adjustment valve device 100 is attached to the tip of the suction hose 12 of the suction device 10, the suction object guide tube 150 is connected to the second connector 106 of the suction pressure adjustment valve device 100, and then a vacuuming operation is performed to guide the object to be suctioned in the lower respiratory tract toward the upper respiratory tract. The object to be suctioned guided toward the upper respiratory tract is then sucked in with a suction device such as a suction catheter, thereby easily achieving minimally invasive sputum suction. Furthermore, in this embodiment, pressurized ventilation is performed before and after the suctioning operation, thereby achieving minimally invasive sputum suction that further reduces the pain and discomfort of the patient P1.

[0078] In particular, at the level of the airway with tracheal cartilage where there is no change in volume, vacuuming creates negative pressure within the airway. Therefore, if there is any airway damage, it may promote bleeding. Therefore, when performing vacuuming on a patient with airway damage caused by a suction catheter or a tracheotomy patient who has a brachiocephalic artery fistula due to the insertion and removal of a tracheal cannula, it is recommended to perform the procedure carefully after observing the patient with a bronchial fiberoptic cable in advance.

[0079] In this embodiment, the system 1 performs vacuuming by bringing the inner surface 151b of the guide tube body 151 of the aspirated object guide tube 150, which is connected to the suction hose 12 via the suction pressure adjustment valve device 100, into contact with the tracheal cannula 20 attached to the throat of the patient P1, and then aspirating the aspirated object guided to the upper respiratory tract side with a suction catheter or the like, but the system can also be applied to other aspects. For example, if the tracheal cannula 20 is not attached to the incision hole A2 formed in the throat of the patient P1 whose larynx is to be removed, the inner lid 152 can be closed on the guide tube body 151 of the aspirated object guide tube 150, the opening 152a at the tip end of the inner lid 152 can be brought into close contact with the incision hole A2, and then vacuuming can be performed to guide the aspirated object, such as sputum, in the lower respiratory tract from the trachea A1 to the terminal bronchioles toward the upper respiratory tract, and then the aspirated object guided toward the upper respiratory tract can be aspirated and removed using a suction catheter or other suction instrument.

[0080] Furthermore, system 1 of this embodiment may be configured as shown in Fig. 13 as one embodiment of the suction pressure adjustment valve device 100, aspirated object guide pipe 150, system 1, and aspirated object guide method using system 1. That is, as shown in Fig. 13, system 1 of this embodiment is applied when aspirating and removing aspirated objects such as sputum from patient P1 who is under artificial respirator management in an ICU or the like after surgery, with a tracheal tube 30 intubated into the trachea A1 of the patient P1.

[0081] Specifically, a tracheal tube 30 is inserted into the trachea A1, the distal end of the tracheal tube 30 is secured with a cuff 32, and a suction object guide tube 150 connected to a suction hose 12 via a suction pressure regulating valve device 100 is brought into close contact with a joint 30a at the proximal end of the tracheal tube 30, thereby performing vacuuming to guide sputum or other suction objects toward the upper respiratory tract. The suction object guided toward the upper respiratory tract is then removed by suctioning the suction object with a suction catheter or other suction tool. Furthermore, if the absolute value of the negative suction pressure during vacuuming is excessive, that is, if the absolute value of the negative suction pressure is greater than the absolute value of the maximum suction pressure, the valve mechanism 110 of the suction pressure regulating valve device 100 is activated to adjust the absolute value of the negative suction pressure to a desired level.

[0082] In this embodiment, the diameter of the opening 151a2 of the aspirated object guide tube 150 is configured to be somewhat larger than the diameter of the joint portion 30a of the tracheal tube 30 to provide some leeway. Specifically, for example, if the outer diameter of the joint portion 30a of the tracheal tube 30 is set to φ15 mm, the inner diameter of the opening 151a2 of the aspirated object guide tube 150 is set to 17 mm, which makes it easier to bring the two components into close contact and prevents the patient from choking due to excessive contact, i.e., the connection of the two components.

[0083] Furthermore, the system 1 of this embodiment may be configured as shown in Fig. 14 even if a body-worn ventilation member such as a tracheal cannula 20 is not intubated. Fig. 14 shows one embodiment of the system 1 for adjusting suction pressure using the suction pressure adjustment valve device 100 of this embodiment, in which the suction pressure adjustment valve device 100 is connected to the end of an inhalation mask 50 covering the oral cavity of the patient P1 to adjust the suction pressure. Note that the inhalation mask 50 may be, for example, an oral-nasal mask or other mask.

[0084] The system 1 of this embodiment is configured by inserting and connecting the first connector 104 of the suction pressure adjustment valve device 100 to the suction hose 12 and fitting the second connector 106 into the connection hole 50a of the inhalation mask 50. By providing the suction pressure adjustment valve device 100 between the suction hose 12 and the inhalation mask 50 in this manner, when the suction device 10 applies suction pressure (negative pressure) to collapse the lungs, if the airway pressure exceeds the maximum suction pressure, the valve mechanism 110 of the suction pressure adjustment valve device 100 is activated. The valve mechanism 110 then activates to open the valve body 112, allowing outside air to flow into the system 1 through the open suction pressure adjustment valve device 100, thereby adjusting the absolute value of the suction pressure to be less than the absolute value of the maximum suction pressure. This reduces the discomfort experienced by the patient due to excessive suction pressure when collapsing the lungs using the inhalation mask 50.

[0085] Furthermore, in order to perform vacuuming with the inhalation mask 50 (oral-nasal mask), if the patient holds their breath and closes their glottis, the lungs cannot collapse and negative pressure is transmitted to the ears, causing pain, so the glottis must be kept open. ALS and muscular dystrophy patients regularly undergo respiratory rehabilitation, so by practicing vacuuming, they can understand the principles of vacuuming and become able to perform effective vacuuming with the inhalation mask 50 even before a tracheotomy is performed. Furthermore, once the patient becomes accustomed to vacuuming with the inhalation mask 50, they can close one nostril and mouth and perform nasal vacuuming in the form of nasal suction.

[0086] Actions and effects of the embodiment:

[0087] Next, we will explain the functions and effects of the suction pressure regulating valve apparatus 100, the body fluid suction device 200, and the system 1 according to one embodiment of the present disclosure. The body fluid suction device 200 and the system 1, which are equipped with the suction pressure regulating valve apparatus 100, and the method for guiding an object to be sucked using them, all have the functions and effects of the suction pressure regulating valve apparatus 100 described in this specification.

[0088] The suction pressure adjustment valve device 100 maximizes the suction pressure to collapse the lungs in a short time, and automatically controls the suction pressure when squeezing the lungs, allowing for highly safe suction. Furthermore, the opening sound of the valve body 112 (valve opening sound, suction sound from the intake port 111a1) mechanically notifies the user that the vacuum effect has been achieved, allowing accurate vacuuming to be performed by anyone. Details of this will be explained further below.

[0089] The present inventors have invented a suction object guide tube 150, which serves as an attachment to the suction hose 12 (suction tube) of a suction device 10 and guides the object toward the upper respiratory tract side of the trachea, to facilitate suction of the object to be suctioned with a suction catheter or other suction tool when suctioning and removing sputum and other such objects from a patient's respiratory tract, including the lower respiratory tract. The present inventors have also developed a suction pressure adjustment valve device 100 of this embodiment, which can be easily attached between the suction hose 12 and the object to be suctioned guide tube 150, as a device for adjusting the suction pressure to reduce discomfort and pain to the patient caused by excessive suction pressure when guiding the object to be suctioned toward the upper respiratory tract using the object to be suctioned guide tube 150.

[0090] The suction pressure adjustment valve device 100 of this embodiment is provided with a valve mechanism 110 on the side surface 102c of the main body 102. The valve mechanism 110 opens and adjusts the suction pressure when the absolute value of the negative suction pressure transmitted from the suction device 10 to the patient's airway via the suction pressure adjustment valve device 100 reaches or exceeds a predetermined value. Therefore, when the suction pressure transmitted from the suction device 10 becomes excessive during suction (discharge of the object to the outside of the body) from the upper airway using the object guide tube 150, the valve mechanism 110 is activated, opening the valve body 112. This prevents the absolute value of the negative suction pressure applied to the patient's airway from exceeding the absolute value of the maximum suction pressure during sputum suction or other such procedures, thereby reducing the patient's discomfort and the risk of damage to the patient's airway due to excessive suction, and enabling safe and effective sputum suction.

[0091] Furthermore, the suction pressure adjustment valve device 100 of this embodiment is configured so that the first connection part 104 tapers in diameter toward the tip, and the second connection part 106 is configured so that it can fit into the connecting pipe 151a of the suction object guide pipe 150 and the connecting hole 50a of the inhalation mask 50. Therefore, when the suction pressure adjustment valve device 100 is attached between the suction hose 12 of the suction device 10 and the suction object guide pipe 150, the tightness of contact between the first connection part 104 and one end of the suction hose 12 and the tightness of contact between the second connection part 106 and the connecting pipe 151a of the suction object guide pipe 150 are improved.

[0092] As a result, the suction pressure from the suction device 10 is adjusted to a desired level and reliably applied to the inside of the aspirated object guide tube 150 via the suction pressure adjustment valve device 100. Then, in order to make it easier to aspirate sputum and other objects present in the lower respiratory tract from the trachea to the terminal bronchiole using a suction catheter or other suction instrument, the suction pressure can be efficiently adjusted to avoid excessive pressure and guided toward the upper respiratory tract, thereby improving suction efficiency while ensuring greater safety.

[0093] That is, by attaching the aspirated object guide tube 150 to the tip of the suction hose 12 of the suction device 10 via the suction pressure adjustment valve device 100 of this embodiment, and then connecting the aspirated object guide tube 150 to a body-worn ventilation member such as the tracheal tube 30, tracheal cannula 20, or inhalation mask 50 attached to the patient, the aspirated object can be guided toward the upper respiratory tract while adjusting the suction pressure. This makes it possible to guide the aspirated object toward the upper respiratory tract while adjusting the suction pressure with a simple procedure, making it possible to suction the aspirated object from the upper respiratory tract (discharge it to the outside of the body) more safely, less invasively, and easily.

[0094] Furthermore, in this embodiment, the suction pressure adjustment valve device 100 is attached to the tip of the suction hose 12 via the first connecting portion 104, and the connecting tube 151a of the suction pressure adjustment valve device 100 is inserted and attached to the second connecting portion 106 of the suction pressure adjustment valve device 100, thereby improving the adhesion between the suction hose 12, the suction pressure adjustment valve device 100, and the suction object guide tube 150 and also improving the adhesion with the body-worn ventilation member such as the tracheal cannula 20 or the tracheal tube 30. Therefore, according to this embodiment, even an unskilled practitioner can adjust the suction pressure to obtain a vacuuming effect equivalent to that of a skilled practitioner, so that anyone can perform equivalent vacuuming while taking safety into consideration.

[0095] In general, when performing sputum suction by inserting a suction catheter connected to a suction hose into the airway, sufficient suction effect cannot be achieved unless the tip of the suction catheter reaches the sputum to be suctioned. Furthermore, blind insertion of a suction catheter poses a risk of airway irritation and damage to the patient's airway due to deep insertion. On the other hand, mechanical cough assist (MI-E) can achieve minimally invasive sputum suction in a short time. However, because the device for mechanical cough assist (MI-E) involves electromechanical control of inspiratory and expiratory pressure, it is expensive. Furthermore, the suction operation, which mechanically applies positive and then negative pressure, requires skilled techniques, making it difficult to perform without training.

[0096] In contrast, if the suction pressure adjustment valve device 100 of this embodiment is used as an attachment that attaches the suction object guide conduit 150 to the tip of the suction hose 12 and then fits tightly to a body-worn ventilation member such as a tracheal cannula 20 or tracheal tube 30 attached to the patient P1, the degree of contact between the suction hose 12 and the suction pressure adjustment valve device 100, the degree of contact between the suction pressure adjustment valve device 100 and the suction object guide conduit 150, and the degree of contact between the suction object guide conduit 150 and the body-worn ventilation member can all be improved. As a result, the suction force (negative pressure) from the suction device 10 is adjusted so as not to be excessive, and is transmitted to the body-worn ventilation member such as the tracheal cannula 20 or tracheal tube 30 without leaking from the areas of contact with the suction hose 12 or the body-worn ventilation member.

[0097] That is, after connecting the first connector 104 of the suction pressure regulating valve device 100 to one end of the suction hose 12, the inner circumferential surface 151b of the guide tube body 151 of the aspirated object guide tube 150 connected to the second connector 106 of the suction pressure regulating valve device 100, on the opening 151a2 side, is brought into close contact with a body-worn ventilation member such as a tracheal cannula 20 or tracheal tube 30 attached to the patient P1. By vacuuming through the guide tube body 151, aspirated objects such as sputum and foreign bodies in the peripheral lower respiratory tract of the patient P1 can be moved toward the upper respiratory tract. This allows the aspirated objects moved toward the upper respiratory tract to be easily aspirated and removed using a suction device such as a suction catheter. In particular, in this embodiment, as described above, by performing positive pressure ventilation using a bag valve mask or the like before the negative pressure vacuum operation and after the aspirated objects guided toward the upper respiratory tract, aspirated objects such as sputum can be easily and minimally invasively removed.

[0098] In this way, by attaching the suction pressure adjustment valve device 100 of this embodiment to the tip of the suction hose 12 and using the object guide pipe 150 connected to the suction pressure adjustment valve device 100 as an attachment that is tightly attached to the body-worn ventilation member worn on the patient P1 side, the object to be aspirated can be easily guided toward the upper respiratory tract while adjusting the suction pressure. This makes it easier to aspirate the object guided toward the upper respiratory tract without causing discomfort to the patient due to excessive suction pressure, thereby improving suction efficiency.

[0099] Furthermore, the suction pressure adjusting valve device 100 is configured so that the suction hose 12 of the suction device 10 can be connected to the first connecting part 104, and so that the second connecting part 106 can be connected to various suction tools such as a suction object guide tube 150 or a catheter. In conventional vacuuming methods, the optimal set pressure and suction time of the suction device 10 vary depending on factors such as the patient's lung capacity and lung condition, the viscosity of the sputum, the specifications of the suction device 10 (aspirator), and the diameter of the suction hose 12, which sometimes makes it impossible to effectively suction sputum.

[0100] In contrast, the suction pressure adjustment valve device 100 of this embodiment is equipped with a valve mechanism 110 that functions as a suction pressure adjustment valve that adjusts the suction pressure when vacuuming. Therefore, by interposing the suction pressure adjustment valve device 100 between the suction hose 12 of the suction device 10 and the object guide pipe 150, it is possible to prevent suction operations at excessive suction pressure. Furthermore, when the valve mechanism 110 opens, the suction sound from the open intake hole 111a1 indicates that the valve has opened, so that the occurrence of the vacuuming effect can be detected by the suction sound, thereby providing a function for notifying the suction status by sound.

[0101] Furthermore, by using the suction pressure regulating valve device 100 when collapsing the lungs before sputum suction, the collapsed state of the lungs can be easily detected by the suction sound made when the valve mechanism 110 opens, allowing for safer, less invasive suction removal of sputum and other aspirated materials. In particular, when performing sputum suction, a method in which a suction catheter is blindly inserted deep into the airway of the patient P1 to induce coughing not only causes pain to the patient P1 but also carries the risk of serious complications such as cerebrovascular disease due to elevated blood pressure and airway damage. However, this embodiment makes it possible to reduce such pain and the risk of complications.

[0102] Furthermore, by interposing the suction pressure adjustment valve device 100 between the suction hose 12 of the suction device 10 and the suction object guide tube 150, even when the set pressure of the suction device 10 is set to the maximum value, if excessive suction pressure is applied to the airway, the valve mechanism 110 opens, thereby preventing suction at a pressure higher than the maximum suction pressure. This makes it possible to collapse the lungs more easily and in a shorter time. Because the suction pressure adjustment valve device 100 thus functions as a suction pressure adjustment valve, it is possible to eliminate the need for a control mechanism for the suction device 10 (aspirator, suction pump), thereby contributing to a lighter, more compact, and less expensive suction device 10.

[0103] Furthermore, in this embodiment, efficient suction of sputum is performed while adjusting the suction pressure without using an expensive device that performs mechanical cough assistance (MI-E), thereby realizing minimally invasive suction of sputum and other suction targets that reduces pain and discomfort to patient P1 and improves the quality of life (QOL) of patient P1. Furthermore, in this embodiment, because the suction pressure adjustment valve device 100 and the suction target guide tube 150 have simple configurations, the suction pressure adjustment valve device 100 and the suction target guide tube 150 can be mass-produced at a lower cost than mechanical cough assistance (e.g., MI-E) or sputum suction methods that use devices (e.g., bronchoscopes, percussion ventilators), and the effort required for preparation and cleanup can be reduced.

[0104] The suction pressure regulating valve device 100 and system 1 have a simple mechanical structure that allows for low-cost mass production, a significant advantage in industrial applicability. Because the suction pressure regulating valve device 100 and system 1 do not require an electrical drive source, they are extremely useful not only in hospitals and home medical settings, but also in disaster medical settings where securing a power source is difficult. Furthermore, they could be offered as an inexpensive attachment that could be included as standard with devices such as the "i-gel" supraglottic airway device (a registered trademark of Intersurgical Ltd.), which is used in over 12 million units annually. This would enable medical professionals worldwide to perform safer, standardized airway clearance procedures without the need for additional equipment. This would strongly promote the decentralization of medical care, shifting respiratory care from hospitals to the home, and significantly contribute to improving patients' quality of life.

[0105] Furthermore, this embodiment makes it possible to guide the material to be aspirated more reliably than sputum suction methods such as postural drainage, squeezing (manual respiratory assistance), etc. In particular, postural drainage and squeezing are associated with the risk of fractures due to position changes in patients who have been bedridden for a long period of time, but with the vacuuming method of this embodiment, the suction pressure can be adjusted to obtain the suction effect of the material to be aspirated regardless of the patient's position, thereby reducing the risk of fractures due to position changes.

[0106] Furthermore, procedures based on the principles of the present invention (methods for guiding aspirated material and sputum suction) are believed to be highly safe at the alveolar level. This is hypothesized to be because, when negative pressure is applied, the smaller, non-cartilaginous bronchioles collapse sequentially, functioning as natural safety valves to protect the delicate alveolar structures at the ends from excessive pressure changes. Histopathological analysis performed by the inventors after the procedures showed no signs of mechanical damage or barotrauma to the alveolar structures, supporting this hypothesis.

[0107] Although one embodiment of the present disclosure has been described in detail above, it will be readily apparent to those skilled in the art that many modifications are possible without substantially departing from the novel features and effects of the present disclosure. Therefore, all such modifications are intended to be included within the scope of the present disclosure.

[0108] For example, a term described at least once in the specification or drawings together with a different term having a broader or equivalent meaning can be replaced with that different term anywhere in the specification or drawings. Furthermore, the configurations and operations of the object to be sucked guide tube and the object to be sucked suction system are not limited to those described in one embodiment of the present disclosure, and various modifications are possible.

[0109] 1 System, 10 Suction device, 12 Suction hose, 14 Suction pump, 16 Storage section, 20 Tracheal cannula, 20a One end, 22 Fixation plate, 24 Cuff, 30 Tracheal tube, 32 Cuff, 50 Inhalation mask, 50a Connection hole, 100 Suction pressure adjustment valve device, 102 Main body, 102a First tube end, 102b Second tube end, 102c Side, 102c1 Opening hole, 104 First connection section, 104a Opening, 106 Second connection section, 106a Base end opening, 110 Valve mechanism, 110a Ventilation groove, 111 Valve chamber, 111a Top surface, 111a1 Intake hole, 111a2 Scale (display section), 111a3 Male thread section (adjustment mechanism), 111b Bottom surface portion, 111b1 communication hole, 111c side portion, 111c1 inner peripheral surface, 111c2 female thread portion (adjustment mechanism), 111d reference point, 112 valve body, 112a outer edge portion, 112b ventilation gap, 113 pressing spring (biasing member), 150 aspirated object guide tube, 151 guide tube main body, 151a connecting tube, 151a1 (connecting tube) opening, 151a2 (guide tube main body) opening, 151b inner peripheral surface, 152 inner lid, 152a (inner lid) opening, 152b inner peripheral surface, 153 tip cap, 154 connection cord, 155 holder, 156 hinge mechanism, 200 body fluid suction device, A1 trachea, A2 incision hole, P1 patient (living body)

Claims

1. A suction pressure adjustment valve device that is connected between a suction hose of a suction device and a body-worn ventilation member to adjust the suction pressure for sucking an object to be suctioned from a living body, comprising: a cylindrical main body; a first connection part provided at a first cylindrical end of the main body for connection to the suction hose; a second cylindrical connection part provided at a second cylindrical end of the main body; and a valve mechanism provided on a side of the main body that opens to adjust the suction pressure when the suction pressure reaches or exceeds a predetermined level.

2. A suction pressure adjusting valve device as set forth in claim 1, wherein the valve mechanism automatically closes mechanically without using an electrical drive source when the suction pressure falls below a predetermined level in an open state.

3. The suction pressure regulating valve device according to claim 1, wherein the valve mechanism comprises: a valve chamber having a communication hole in the bottom surface thereof that communicates with the main body portion and an intake hole in the top surface thereof through which gas can flow; a valve body that blocks the intake hole in a closed state and moves away from the intake hole to open the intake hole when the suction pressure transmitted from the main body portion through the communication hole reaches a predetermined magnitude or greater; and a biasing member that biases the valve body toward the intake hole.

4. A suction pressure regulating valve device as described in claim 3, wherein the valve chamber has a cylindrical side surface, the valve body has a disk shape, and an air gap is formed between the outer edge of the valve body and the inner surface of the side surface as a uniform gap with the inner surface of the side surface around the entire circumference of the outer edge.

5. The suction pressure regulating valve device according to claim 4, wherein the valve mechanism further comprises an adjustment mechanism that adjusts the biasing force of the biasing member by rotating the top surface portion relative to the side surface portion.

6. A suction pressure regulating valve device as described in claim 3, wherein when the magnitude of the suction pressure transmitted from the main body through the communication hole exceeds the magnitude of the biasing force on the valve body by the biasing member, the valve body moves away from the intake hole to open the intake hole.

7. A suction pressure adjustment valve device as described in claim 1, wherein the second connection part is configured to be able to fit into either an aspirated object guide tube that guides the aspirated object in the trachea of ​​the living body toward the upper respiratory tract by the suction pressure from the suction device, or the body-worn ventilation member worn by the living body.

8. A suction pressure adjustment valve device as described in claim 7, wherein the second connecting portion has an inner diameter equal to the outer diameter of the outer diameter portion of the base end of the connecting pipe provided on the suction object guide pipe, and an outer diameter equal to the inner diameter of the connecting hole provided on the body-worn ventilation member.

9. The suction pressure regulating valve device according to claim 1, further comprising a display unit that displays the suction pressure.

10. A system for adjusting the suction pressure for sucking an object to be aspirated from a living body, comprising: a suction device provided with a suction hose; a suction pressure adjustment valve device according to any one of claims 1 to 9 connected between the suction hose and a ventilation member to be worn on the human body; and a suction object guide pipe connected to a second connection part of the suction pressure adjustment valve device, which guides the object to be aspirated in the trachea of ​​the living body toward the upper respiratory tract by the suction pressure from the suction device.

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