TWI798039B - Pressure regulator - Google Patents

Abstract

The present disclosure provides a pressure regulator for automatically regulating and indicating an inner pressure of a cuff. It includes a hollow housing with first and second chambers, a valve, first and second openings, an indicator, and a biasing element. Further, a syringe can be coupled with the valve and the first opening to which a cuff can be coupled. The biasing element is configured within the second chamber and engaged the housing and the indicator, respectively, and the arrangement of the indicator and the biasing element are co-axial. In addition, the arrangement being such that a balance between a restoring force from the biasing element and first fluid pressure from the cuff can cause a longitudinal movement of the indicator along the housing to indicate an equilibrium pressure thereby, wherein the restoring force of the biasing element maintains the equilibrium pressure in a range.

Description

Stabilizer

The present invention claims the priority of U.S. Patent Provisional Application No. US63/168,273 filed on March 31, 2011, and its entire contents are hereby incorporated by reference.

The invention relates to a pressure indicating device. In particular, the present invention relates to a device for regulating and indicating the air pressure of an airway device balloon.

Regulation of endotracheal tube (ETT) and laryngeal mask (LMA) balloon pressures is the most important part of patient care and prevention of respiratory-associated pneumonia.

The goal of monitoring ETT cuff pressure is to achieve a seal between the airway and the ETT cuff at a pressure high enough to prevent the patient from microaspiration of contaminated oropharyngeal contents, but low enough not to cause damage to the airway (mucosa or cartilage). It is recommended to keep the ETT balloon pressure between 20~30cmH ₂ O.

However, manual manometers used for routine intermittent ETT pressure measurements and corrections cannot avoid underinflation or overinflation between measurements. Consequently, fewer than one fifth of patients had correct EET pressures in the 8-hour period between manual corrections. In addition, cuff pressure can also change due to airway tone or patient position.

Similarly, high balloon pressure may lead to lingual, hypoglossal, and recurrent laryngeal nerve paralysis in patients using LMA, but when balloon pressure is kept below 60 _cmH2O , airway sealing is better and postoperative sore throat The incidence rate is very low.

Many attempts have been made in the art to solve this problem. One approach focuses on providing an indicator connected to the balloon to continuously provide pressure information.

US Patent No. 8,033,176 B2 discloses an internal pressure indicator for an inflatable bladder. The device consists of a bellows and a housing with two openings. The inner cavity of the telescoping bag communicates with the atmosphere. The opening of the housing is used to connect the syringe and the balloon. When the internal pressure of the air bag increases, the bellows will be compressed until the pressure and the resilience of the bellows are balanced. The state of the bellows indicates the pressure value of the airbag. Thus, the device can provide a pressure indication when the bladder pressure is higher than atmospheric pressure. However, the bellows cannot show the negative pressure of the airbag when the airbag needs to be fully deflated.

US Patent No. 9,901,693 B2 discloses another design with a balloon within a hollow sphere. In addition to monitoring pressure, the design can also regulate pressure within a specific range. Specifically, the design uses the balloon's flexibility to adjust pressure. Since the concave area of the hollow ball is a buffer volume, it is difficult to further increase and the adjustment ability is limited. If a large buffer volume is required, the size of the entire device becomes too large. In addition, balloon size is subjective and difficult to quantify, adding to the difficulty of perceiving balloon pressure. In other words, within a certain volume range, the balloon can maintain the pressure in the range of 20~30cmH ₂ O. In addition, the 693 patent discloses that when the volume is in the range of 2/3 to 3/4 of the whole, the pressure can be maintained between 20~30cmH ₂ O, which also means that 2/3 of the volume is wasted and cannot be used as a buffer. Therefore, the design disclosed in the '693 patent has the problem of not being able to effectively utilize the internal space of the device, which in turn may cause the entire device to be too large.

Numerous studies have demonstrated the effectiveness of this pressure indicating device. For example: Sole ML, Penoyer DA and others found that 30% of the air bag pressure will be reduced to less than 20cmH ₂ O through continuous monitoring technology, such as Assessment of endotracheal cuff pressure by continuous monitoring: a pilot study, Am.J.Crit.Care , described in 2009. However, balloon pressure changes are complex and include leakage of air through the balloon balloon material and changes in patient posture. Therefore, in addition to continuous monitoring of cuff pressure, a better strategy is to automatically control and maintain the pressure within a specific range.

Jerome E. Dauvergne et al. completed a study evaluating the necessity of an autoregulation system. (Automatic regulation of the endotracheal tube cuff pressure with a portable elastomeric device. A randomized controlled study, SFAR, 2020) The results of the study showed that only 2.1% of the underinflation events occurred during the 48-hour ventilation period, while in the absence of automatic regulation The incidence of ventilation was 14.9%. In addition, at least one underinflation event was detected in 62.5% of patients using manually corrected cuff pressure. If an automatic correction system is used, the incidence can be effectively reduced to 17.9%.

In order to further reduce the risk of underinflation or overinflation of the airbag, the present disclosure proposes an airbag pressure monitoring and stabilizing device with an exquisite structure. Compared to previous designs, the present disclosure has a larger buffer volume to regulate pressure if the device is similar in size. The indication of balloon pressure may be quantitative. Moreover, the device can provide pressure information not only when the pressure is positive, but also when the pressure is negative, which is very important when the airbag needs to be fully deflated to be removed.

The present disclosure provides a pressure stabilizing device for automatically adjusting and indicating the internal pressure of the airbag. The pressure stabilizing device includes a hollow shell having a first chamber, a second chamber, a valve, a first opening, a second Openings, indicators and biasing elements. In addition, the syringe can be connected to the pressure stabilizing device through the valve, and the air bag can be connected to the pressure stabilizing device through the first opening. The biasing element is arranged in the second chamber and engaged with the housing and the indicator respectively, and the indicator and the biasing element are arranged coaxially. Furthermore, such an arrangement is such that a balance between the restoring force from the biasing element and the first fluid pressure from the bladder can cause the indicator to move longitudinally of the housing to thereby indicate the balancing pressure, wherein the restoring force of the biasing element Maintain this equilibrium pressure within a range.

In another specific embodiment, the housing includes a first portion and a second portion, and the first opening and the valve are configured in the first portion. The second opening, indicator and biasing element are arranged in the second portion.

In another specific embodiment, the first portion includes a first longitudinal axis, the second portion includes a second longitudinal axis, and both the first longitudinal axis and the second longitudinal axis are not parallel to each other.

In another specific embodiment, the first portion further includes a second indicator.

In another particular embodiment, a portion of the second portion of the housing is received within said first portion of the housing.

In another embodiment, the housing comprises a guiding element for connecting said valve and said first chamber.

The present disclosure also provides another pressure stabilizing device for automatically adjusting and indicating the internal pressure of the airbag. The voltage stabilizing device includes a longitudinally extending and hollow housing, a deformable element and a biasing element. Furthermore, the longitudinally extending and hollow housing comprises a first opening to which a balloon can be connected, a valve to which a syringe can be connected, a second opening through the first housing and a guide element. Furthermore, the first chamber is in fluid communication with the first opening and the valve via the guide element. The second opening is used to keep the pressure in the second chamber consistent with atmospheric pressure. The biasing element is respectively engaged with the housing and the deformable element, and the deformable element and the biasing element Configured as coaxial. Furthermore, this configuration is such that the balance between the restoring force from the biasing element and the fluid pressure from the bladder can cause compression or extension of the deformable element, thereby indicating an equilibrium pressure, and the restoring force of the biasing element maintains the equilibrium pressure within a range.

In another specific embodiment, the housing includes a window.

The present disclosure also provides another pressure stabilizing device for automatically adjusting and indicating the internal pressure of the airbag. The pressure stabilizing device includes a longitudinally extending and hollow first housing, a second housing disposed in the first housing, an indicator disposed in the first housing and used to define the first and second chambers, and an indicator configured in the first housing A biasing element within the first housing and engaged with the second housing and the indicator respectively. A first longitudinally extending and hollow housing includes a first opening connectable to the balloon and a second opening having a valve to which a syringe is connectable. The second housing includes a third opening through the first housing. The first chamber is in fluid communication with the first opening and the second opening, and the third opening is used to maintain the pressure in the second chamber consistent with atmospheric pressure. The indicator and biasing elements are arranged coaxially. In addition, this configuration is such that the balance between the restoring force from the biasing element and the first fluid pressure from the bladder causes movement of the indicator to indicate the equilibrium pressure, and the restoring force of the biasing element maintains the equilibrium pressure at a within range.

In another particular embodiment, the indicator comprises a deformable element.

In another particular embodiment, the deformable element is rubber, a membrane, a balloon or a bellows.

In another embodiment, the deformable element is in a compressed state when the pressure of the first fluid is higher than the restoring force.

In another embodiment, the deformable element assumes an extended state when the pressure of the first fluid is higher than the restoring force.

In another specific embodiment, when the pressure of the first fluid is higher than the restoring force, the volume of the first chamber increases.

In another specific embodiment, the volume of the first chamber decreases when the pressure of the first fluid is lower than the restoring force.

In another embodiment, the spring has a longest longitudinal length when the deformable element is deformed and when the fluid pressure is equal to atmospheric pressure.

In another embodiment, the housing comprises fixing elements for anchoring said stabilizing means on the pipe.

In another specific embodiment, the range is 20-30 cmH ₂ O.

In another specific embodiment, the range is 40-60 cmH ₂ O.

In another particular embodiment, the biasing element is a spring.

In another specific embodiment, the k value of the bias element is 1.5-2.5 g/mm.

In another embodiment, when the balance pressure is not within the range, the syringe is used to adjust the balance pressure to keep the balance pressure within the range.

1,3,5,6,7,8: voltage stabilizing device

2: Syringe

4: endotracheal tube

10,30,70,80: Outer shell

11,51,61: the first shell

12,32,52: Inner shell

13,53,63: second shell

14,54,64: Spring

15,65,75,85: indicators

41: tube body

43: air bag

45: Connector

74: Bias element

101,701: remote

103,703: Proximal

105,505,605,705,805: first chamber

107,607: second chamber

111,511,611,711: first opening

113,713,813: windows

115,515,615: hook

121: The third opening

123: concave cavity

125: Groove

131,531,631,731: valve systems

133,533,633: second opening

151,551,651,751: sliding elements

153,753,853: piston head

431: pipe

521: Open end

553: Membrane

653: expansion bag

817: second indicator

1311, 1511: hole

1315: valve

1531,7531: deformable parts

1533: ring part

6311: base

8171: Second valve

FIG. 1 is a schematic diagram of an airbag with a pressure stabilizing device with a syringe according to an embodiment of the present disclosure.

2A and 2B are schematic diagrams of a voltage stabilizing device. In addition, FIG. 2A is a side view of the voltage stabilizing device, and FIG. 2B is a rear view of the voltage stabilizing device.

3A and 3B are schematic diagrams of a voltage stabilizing device. In addition, FIG. 3A is an exploded view of the voltage stabilizing device, and FIG. 3B is an isometric view of the inner cylinder of the rear view of the voltage stabilizing device.

4A to 4J are non-limiting embodiment illustrations to reveal side cross-sectional views of a voltage stabilizing device, and wherein the deformable element is a piston. In addition, FIG. 4A is a side sectional view of the voltage stabilizing device. 4B and 4C are side cross-sectional views of the interior of the voltage stabilizing device. 4D, 4E and 4G~4I are side sectional views of the indicator in the voltage stabilizing device, and FIG. 4D is a side sectional view of the indicator of the voltage stabilizing device. Fig. 4F is a side sectional view of another voltage stabilizing device.

Figures 5A to 5C are non-limiting embodiment illustrations to reveal side cross-sectional views of a voltage stabilizing device and the deformable element is a membrane. In addition, FIG. 5A is a side sectional view of the voltage stabilizing device, and FIGS. 5B and 5C are side sectional views of an inner part of the voltage stabilizing device.

6A to 6C are non-limiting embodiment illustrations to reveal side cross-sectional views of the voltage stabilizing device, and the deformable element is a bellows. In addition, FIG. 6A is a side sectional view of the voltage stabilizing device, and FIGS. 6B and 6C are side sectional views of the inside of the voltage stabilizing device.

7A to 7C are schematic illustrations of non-limiting embodiments to reveal side cross-sectional views of a voltage stabilizing device.

8A to 8C are non-limiting embodiment illustrations to reveal side cross-sectional views of a voltage stabilizing device.

The drawings are schematic and non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. The dimensions and relative dimensions do not necessarily correspond to actual reductions practiced in the present disclosure. Any reference signs within the claimed scope of an invention should not be construed as limiting the scope. The same reference symbols denote the same elements in the various drawings.

The making and using of specific embodiments of the present disclosure are discussed in detail below. It should be appreciated, however, that the embodiments provide many applicable inventive concepts that can be embodied in a wide variety of specific Below. The specific embodiments discussed are merely illustrative of specific ways to make and use the embodiments, and do not limit the scope of the disclosure.

Like reference numerals are used to refer to like elements throughout the various views and illustrative embodiments. Reference will now be made in detail to the exemplary embodiments illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and description to refer to the same or like parts. Shapes and thicknesses may be exaggerated for clarity and convenience of drawings. The description will be particularly directed to elements forming part of, or cooperating more directly with, a device according to the present disclosure. It is to be understood that elements not specifically shown or described may take various forms. In the description of this patent application, references to "an embodiment" or "a certain embodiment" mean that a specific feature, structure, or characteristic described in relation to the embodiment is included in at least one embodiment. Therefore, the phrases "in one embodiment" or "in a certain embodiment" appearing in different places in the description of this patent application do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics described above may be combined in any suitable manner in one or more embodiments. It should be understood that the following drawings are not drawn to scale; rather, these drawings are for illustration only.

Like reference numerals are used to designate the same or like elements throughout the various views of the drawings, while showing and describing the illustrative embodiments described in this patent application. The drawings are not necessarily to scale and in some instances have been exaggerated and/or simplified for illustrative purposes. Those having ordinary knowledge in the field of the present invention will have to understand the many possible applications and variations of the description of this patent application from the following illustrative specific examples in this patent application specification.

definition

It will be understood that when an element is referred to as being "on" another element, it can be directly on the other element or intervening elements may be present. Conversely, when an element is said to be "directly on" another element, there are no intervening elements.

It should be understood that the singular forms "a", "an", "the", and "said" also include the plural forms unless the context clearly indicates otherwise. Furthermore, the reference terms "bottom" or "top" may also be used in the drawings to explain the relationship between an element and another element.

The term "fluid" refers to a liquid or a gas. In this disclosure, preferably, "fluid" refers to air. However, the term "fluid" should not be limited to air or liquids.

The term "guiding element" refers to an element used to guide the flow of fluid in a pressurized device, such as for guiding fluid (eg: air) into the first chamber of the pressurized device after entering from the first chamber of the pressurized device. Chamber. A system of valves, or allowing fluid in a regulator to flow to each opening to maintain pressure balance. More specifically, the guide element may be a space formed between two walls, a groove on the housing or a separate channel. In a preferred embodiment of the present disclosure, the guiding element is a space between the outer casing and the inner casing.

Unless otherwise defined, all terms (including scientific and technical terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this patent application description belongs. It should be further understood that the meanings of terms defined in commonly used dictionaries should be consistent with the meanings in the relevant fields and in the context of this patent application description, and will not be interpreted too ideally or too formally, unless clearly defined herein.

Figure 1 reveals the endotracheal tube 4 and the pressure regulation system. Further, the endotracheal tube 4 includes: a tube body 41 with openings at both ends, a balloon 43 and a connector 45 . The airbag 43 is disposed near one end of the tube body 41 , and the connector 45 is disposed at the opposite end thereof. In addition, the pressure regulating system includes a pressure stabilizing device 1 and an injector 2 for regulating and monitoring the pressure in the air bag 43 . More specifically, the tube 431 extends from the air bag 43 , and the tube 431 can be connected with the voltage stabilizing device 1 . Therefore, the pressure stabilizing device 1 , the air bag 43 and the tube 431 are in fluid communication. The fluid pressure (for example: air pressure) in the airbag 43 or the pressure stabilizing device 1 is passed through the tube The sub-431 are balanced and consistent with each other. In addition, when the balance fluid pressure in the airbag 43 is not within the expected range, the pressure stabilizing device 1 can automatically adjust the fluid pressure in the airbag to the expected range. In addition, when the balance fluid pressure in the airbag 43 is outside the range that can be automatically adjusted by the pressure stabilizing device 1, medical professionals can increase or decrease the balance fluid pressure in the pressure stabilizing device 1 through a syringe to adjust the fluid pressure inside the airbag. , bringing it back into the desired range.

Please refer to FIG. 2 for the following content. FIGS. 2A and 2B are schematic diagrams of the voltage stabilizing device 1 . FIG. 2A is a side view of the voltage stabilizing device 1 , and FIG. 2B is a rear view of the voltage stabilizing device 1 . As shown in FIG. 2A , the hollow housing (eg, the outer housing 10 ) has two parts: a first housing 11 and a second housing 13 (also referred to as a distal part and a proximal part, respectively).

In a preferred embodiment, the first housing 11 and the second housing 13 are hollow cylinders with an open end and a closed end, and the first housing 11 and the second housing 13 are connected to each other through the open ends And form a whole (for example: outer casing 10). The shapes of the first housing 11 and the second housing 13 in this specific embodiment are merely examples, and are not limited to cylindrical shapes. It is worth mentioning that the first housing 11 and the second housing 13 can be manufactured separately and then assembled into a whole during manufacture, or can be manufactured in one piece. In addition, the first housing 11 has a first opening 111 , a window 113 and a fixing element (for example: a hook 115 ). Therefore, the pressure stabilizing device 1 can be installed on the tube body 41 of the endotracheal tube 4 for convenient use. Both the first opening 111 and the window 113 are disposed at the closed end of the first housing 11 (ie, the distal end 101 of the voltage stabilizing device 1 ), and the window 113 is disposed between the first opening 111 and the first housing 11 . The first opening 111 in FIG. 1 is used to connect the tube 431 extending from the air bag 43 .

The second housing 13 has a valve system 131 including: a valve (not shown in the figure), a hole 1311 , and a second opening 133 . Further, the second opening 133 is disposed at the closed end of the second housing 13 (ie, the proximal end 103 of the voltage stabilizing device 1 ). As shown in FIG. 2B, the hole 1311 of the valve system 131 is provided at The center of the closed end of the second housing 13 (ie, the proximal end 103 of the voltage stabilizing device 1 ), and the second opening 133 is disposed at the closed end of the second housing 13 near the hole 1311 . The hole 1311 in FIG. 1 is used to connect with the syringe 2 .

Please refer to FIG. 3A for the following content, which discloses an exploded view of the voltage stabilizing device 1 . As previously shown in FIG. 2A , the outer casing 10 of the voltage stabilizing device 1 includes: a first casing 11 and a second casing 13 . In addition, an indicator 15 , a biasing element (eg spring 14 ), an inner housing (eg inner housing 12 ), and a valve 1315 in the valve system 131 are accommodated in the first housing 11 and the second housing 13 . It is worth noting that the indicator 15 is composed of a sliding element 151 and a piston head 153 , and the piston head 153 is arranged at the distal end of the sliding element 151 . The inner housing 12 is also a hollow cylinder having an open end and a closed end (also referred to as distal and proximal ends, respectively). The third opening 121 is arranged at the closed end (near end). The position of the third opening 121 is aligned with the second opening 133 on the second housing 13 . Therefore, when all elements are combined, the third opening 121 may be connected with the second opening 133 . The spring 14 is disposed in the inner casing 12 , and the two ends of the spring 14 engage with the sliding element 151 and the inner side of the closed end of the inner casing 12 respectively. Since the voltage stabilizing device 1 utilizes the spring 14 to drive the indicator 15 to move, it has the advantages of: (1) providing stable force, (2) not easy to creep, (3) effectively utilizing the internal space and not occupying space.

Please refer to FIG. 3B below, which discloses a perspective view of the proximal end view of the inner housing 12 . As can be clearly seen from the figure, the inner housing 12 has a cavity 123 configured at the center of the closed end and a plurality of guiding elements (such as but not limited to recesses arranged on the closed end or the side wall of the inner housing 12). slot 125). The cavity 123 is used to accommodate the valve 1315 in FIG. 3A to form a valve system 131 , and the cavity 123 is a closed cavity. Groove 125 is used to direct fluid from valve system 131 to first chamber 105 in FIG. 4A and vice versa.

4A to 4I show side cross-sectional views of the voltage stabilizing device 1 , and the indicator 15 includes a deformable element (eg, a piston head 153 ). Please refer to the side sectional view of the voltage stabilizing device 1 in FIG. 4A for the following content. It discloses the relative positions of the sliding element 151 , the piston head 153 and the inner housing 12 in the outer housing 10 of the voltage stabilizing device 1 . In order to illustrate the function mechanism of the indicator 15 in the outer casing 10 more clearly, FIGS. 4A to 4F do not reveal all components of the voltage stabilizing device 1 . The indicator 15 divides the inner space of the outer casing 10 into a first chamber 105 and a second chamber 107 . In other words, the indicator 15 serves to delimit the first chamber 105 and the second chamber 107 . The indicator 15 is housed within the inner housing 12 . The sliding element 151 guides the indicator 15 to slide along the A-axis direction/longitudinal direction of the voltage stabilizing device 1 (ie from the distal end to the proximal end, and vice versa). The piston head 153 is made of a resilient material, such as rubber, so as to form an airtight seal, thus preventing fluid communication between the first chamber 105 and the second chamber 107 . Furthermore, the gap or space between the outer housing 10 and the inner housing 12 may act as a guiding element, thus bringing the first chamber 105 , the first opening 111 and the valve system 131 into fluid communication. In addition, the third opening 121 of the inner case 12 passes through the second opening 133 (ie hole) of the outer case 10 and directly communicates with the outside. Therefore, the third opening 121 is used to keep the pressure in the second chamber 107 consistent with the atmospheric pressure.

4B and 4C disclose side sectional views of the inner housing 12 and the indicator 15 of the voltage stabilizing device 1 in different states. Referring to FIG. 4B , when the force applied to the indicator 15 from the second chamber 107 is greater than the force from the first chamber 105 , the indicator 15 is pushed and then moved to the distal end of the inner housing 12 . Therefore, the second chamber 107 has the largest volume at this time. Please refer to FIG. 4C again, which reveals the opposite situation from FIG. 4B, wherein the force from the first chamber 105 (ie, the pressure in the airbag 43 in FIG. 1 ) exerts a higher force on the indicator 15 than the force from the second The power of the chamber 107 causes the indicator 15 to be pushed and then moved to the proximal end of the inner housing 12 . Therefore, at this time, the volume of the first chamber 105 is the largest, and its preferred maximum volume is about 5.5ml.

This design has unexpected effects due to the buffer space provided. Please refer to FIG. 4D for the following content. For example, assume that the original volume of the airbag is 6ml, and its pressure is set to an intermediate value (ie, the gauge pressure is _25cmH2O ). Please refer again to the data of the groups marked with diamonds and solid lines in Figure 4D. If the airbag is not connected with a pressure stabilizing device, the volume of the airbag must be kept at 4~8ml (equivalent to about the original volume of the airbag±2ml) in order to keep the gauge pressure within the range of 20~30cmH ₂ O, but the reality is that the human body is likely to Volume changes outside the above range due to contraction or relaxation of the airway. Please refer to the data of groups marked with circles and dotted lines in FIG. 4D again. Conversely, when the pressure stabilizing device is connected to the airbag, the allowable volume variation range is greatly increased, and the airbag pressure can be maintained within the standard range within the range of 2-11ml (that is, the airbag decreases by 4ml or increases by 5ml).

4E and 4F disclose side cross-sectional views of indicator 15 . As mentioned above, the indicator 15 includes: a sliding element 151 and a piston head 153 . Furthermore, the sliding member 151 has a hole 1511 provided at the center thereof, and the piston head 153 has a deformable portion 1531 and a ring portion 1533 . Thus, when the atmospheric pressure in the second chamber 107 is higher than the pressure in the first chamber 105 and causes the indicator 15 to move and engage the distal end 101 of the first housing 11, as shown in FIGS. 4A and 4B , the atmospheric pressure This will cause the deformable portion 1531 to deform convexly and be observed in the window 113 of the first housing 11 in FIG. 4A . FIG. 4G is a side sectional view of another non-limiting embodiment to reveal the voltage stabilizing device 3 . The main components of the voltage stabilizing devices 1 and 3 are the same, wherein the only difference between the voltage stabilizing devices 1 and 3 is the outer casing. Specifically, the outer casing 10 of the voltage stabilizing device 1 is composed of a first casing 11 and a second casing 13 , and the inner casing 12 is accommodated in the outer casing 10 . However, the inner housing 32 of the voltage stabilizing device 3 is not completely accommodated in the outer housing 30 . A part of the inner case 32 of the voltage stabilizing device 3 is directly exposed to the outside.

4H-4J show side sectional views of the voltage stabilizing device 1, and illustrate the actions of the indicator 15 and the spring 14 in different states. Referring to FIG. 1 and FIGS. 4H to 4J below, the first opening 111 of the voltage stabilizing device 1 is connected to the air bag 43 through a tube 431 , and the syringe 2 is connected to the voltage stabilizing device 1 through a valve system 131 . When the valve system 131 is closed, the air bag 43 and the first chamber 105 form a closed space with a certain fluid volume. In other words, the capacity (total internal volume) of the air bag 43 and the first chamber 105 is fixed when the valve system 131 is closed. When the airway (trachea) compresses the balloon 43 (ie the volume of the balloon 43 decreases), the indicator 15 in the inner housing 12 will tend to move towards the proximal end 103 to increase the volume of the first chamber 105 to keep it constant.

FIG. 4H reveals that the pressure stabilizing device 1 is in a state where it is not connected to the air bag or is connected to the air bag and the balance gauge pressure is lower than 20 cmH ₂ O. In this case, the spring 14 drives the indicator 15 to move to the distal end 101 of the voltage stabilizing device 1 . More specifically, the restoring force of the spring 14 causes it to return from its compressed length to its original length, thereby causing the indicator 15 attached thereto to move accordingly. In a preferred embodiment, spring 14 has a k value of about 1.9 g/mm.

Please refer to FIG. 4I for the following content, the pressure stabilizing device 1 is connected with the air bag placed in the patient's airway (trachea). As mentioned above, when the pressure stabilizing device 1 and the air bag are connected through the tube 431 , the pressures in the first chamber 105 and the air bag 43 will be balanced due to the connection. In other words, when the airway of the patient squeezes the inflated balloon 43 (i.e. reduces the volume) and increases the pressure therein, it will force the indicator 15 to tend to move towards the proximal end 103 to increase the volume of the first chamber 105, To maintain the same total volume (ie the same equilibrium pressure). In a preferred embodiment, the first shell 11 and the inner shell 12 are made of translucent or transparent materials. Thus, the position of the indicator 15 relative to the inner housing can be used to indicate the pressure inside the bladder 43 . In addition, the indicator 15 is subjected to fluid pressure and restoring force from the first chamber 105 (which is completely opposite to the fluid pressure from the spring 14). Specifically, the restoring force of the spring 14 applied to the indicator 15 can be used to adjust the volume of the first chamber 105 by moving the indicator 15 to further adjust the balance pressure inside the air bag 43 and the first chamber 105 . Figure 4H reveals that the balance gauge pressure inside the first chamber 105 or bladder 43 is about 30 _cmH2O , therefore, the first chamber 105 has a maximum volume.

Under normal circumstances, the pressure of the air bag may be affected by a variety of reasons, including: changes in the patient's position, changes in muscle or tissue stiffness, and operation of the ventilator. As disclosed in Figures 4H and 4I, when the airbag pressure fluctuates, the pressure stabilizing device 1 can function as a pressure buffer. As the pressure decreases, the spring 14 will push the indicator 15 to reduce the total volume of the first chamber 105 and the bladder. The reduction in volume can again increase the pressure. Therefore, the pressure can be kept within a certain value. In other words, the airbag pressure is controlled by the spring 14 . The situation is similar when the pressure inside the balloon increases. Specifically, the spring 14 in the voltage stabilizing device 1 is in a "preload" state, and there is no waste of volume at all, and all the volume can be used as a buffer for adjusting pressure changes.

0atm。進一步地，當平衡表壓力

0atm時，大氣壓會通過滑動元件151的孔1511，使活塞頭153的可變形部分1531變形，並使可變形部分1531出現在第一殼體11的窗口113中。因此，可變形部分1531是否顯示在窗口113中可以作為指示或標誌來幫助醫療專業人員識別是否可以從患者的呼吸道中取出氣管導管4。此外，彈簧14的負載範圍為大約70~100g。 Figure 4 reveals the state of the pressure stabilizing device 1 when a medical professional attempts to remove the endotracheal tube 4 from the patient's airway. Therefore, professional medical care needs to confirm that the air bag 43 is completely compressed, so as to prevent the air bag 43 from injuring the patient's airway or causing discomfort during removal. To fully compress the balloon 43, the medical professional may use the syringe 2 to draw fluid from the balloon 43 and the first chamber 105 to reduce their volume (ie reduce the equilibrium pressure within the balloon 43 and the first chamber 105). In a preferred embodiment, when the air bag 43 is fully compressed, the balance gauge pressure inside the air bag 43 and the first chamber 105

0 atm. Furthermore, when the balance gauge pressure

At 0 atm, atmospheric pressure will pass through the hole 1511 of the sliding element 151 to deform the deformable portion 1531 of the piston head 153 and make the deformable portion 1531 appear in the window 113 of the first housing 11 . Therefore, whether the deformable portion 1531 is displayed in the window 113 can be used as an indication or a sign to help medical professionals identify whether the endotracheal tube 4 can be removed from the patient's airway. In addition, the load range of the spring 14 is about 70~100g.

As stated above, it is clear that the present disclosure is more efficient than the prior art because it has the spring 14 and is more efficient than expected. More specifically, the present voltage stabilizing device 1 includes a spring 14 . It can detect whether the pressure value in the airbag 43 is within the target range, and then automatically adjust the pressure in the airbag 43 so that it falls within the target range. 5A-5C disclose a preferred embodiment of the voltage stabilizing device 5 . Figure 5A is a side sectional view of the voltage stabilizing device 5 and reveals all features. As shown in FIG. 5A , the voltage stabilizing device 5 is mainly composed of an outer shell having a first shell 51 and a second shell 53 , an inner shell 52 , a sliding element 551 , a spring 54 and a membrane 553 (or a balloon). The voltage stabilizing device 5 is similar to the voltage stabilizing device 1 , the first housing 51 has a first opening 511 and a hook 515 , and the second housing 53 has a valve system 531 and a second opening 533 . It should be noted that the difference between the two is that the pressure stabilizing device 5 has no piston head, but a membrane 553 , and there is no window between the first housing 51 and the first opening 511 . Figure 5 has another Configuration of windows in a specific embodiment. In a preferred embodiment, the membrane 553 is a balloon made of PVC, PU or similar materials, which is characterized by thin thickness. In a preferred specific embodiment, the disclosed membrane, balloon or stretchable bag is made of a relatively inelastic material, so that the influence of the equivalent spring force can be ignored when the membrane deforms and expands, making it easier to design (one less to consider the elements of). In addition, as the membrane expands, the membrane gradually recovers its shape from a flat state, but the entire membrane does not deform and expand like a normal balloon.

The membrane 553 is disposed inside the first casing 51 , and the periphery of the membrane 553 is closely connected with the open end 521 (ie, the distal end) of the inner casing 52 (it can be achieved by using glue or any other way of forming a tight connection). Therefore, the voltage stabilizing device 5 may provide a more precise regulation capability than the voltage stabilizing device 1 , depending on the material chosen for the membrane 553 . More specifically, the membrane 553 itself is made of a material that can be compressed (ie accommodates the first chamber 505). Therefore, the combination of spring 54 and membrane 553 can provide better modulation.

Figures 5B and 5C are also side sectional views, but they only disclose some components to illustrate how the pressure regulator 5 operates as disclosed in Figure 4F, the pressure stabilizing device 5 is in a normal state, and is not connected to the endotracheal tube 4 in Figure 1 , the absolute pressure inside the first chamber 505 is about 1 atm. Referring now to FIG. 5C , the pressure stabilizing device 5 is now connected to the balloon placed in the patient's airway (trachea). Additionally, fluid from the balloon will cause the membrane 553 to expand to increase the volume of the first chamber 505 . When the fluid pressure in the first chamber 505 is balanced with the contracting force of the membrane 553 and the restoring force of the spring 54 applied to the sliding element 551, the movement of the sliding element 551 will stop. The position of the sliding element 551 relative to the inner housing 52 is representative of the equilibrium pressure within the bladder and first chamber 505 . In addition, if a medical professional wants to adjust (eg decrease) the inflation volume of the airbag 43 , he can adjust (eg increase) the volume of the first chamber 505 through the syringe 2 . For example, the fluid (ie air) in the syringe 2 is injected into the first chamber 505 .

6A~6C disclose another specific embodiment of the voltage stabilizing device 6 . FIG. 6A is a side sectional view of the voltage stabilizing device 6 and reveals all its features. 6B-6C are side sectional views of the voltage stabilizing device 6 inside, And the movement of the sliding element 651 is revealed. As shown in Figure 6A, the voltage stabilizing device 6 is mainly composed of an outer shell (without an inner shell) with a first shell 61 and a second shell 63, an indicator 65 with a sliding element 651 and a bellows 653, and a spring 64. composition. The components of the voltage stabilizing device 6 are similar to those of the voltage stabilizing device 5 . For example, the first housing 61 has a first opening 611 and a hook 615 , and the second housing 63 has a valve system 631 and a second opening 633 . It is worth noting that the difference between the two is that the pressure stabilizing device 6 has no inner casing, and the two ends of the telescoping bladder 653 are respectively connected to the sliding element 651 and the base 6311 of the valve system 631 . Therefore, the sliding member 651 slides accordingly. The sliding element 651 and the telescoping bladder 653 form the second chamber 607, and the second opening 633 is used to keep the pressure in the second chamber 607 consistent with the atmospheric pressure. The material of the expansion bag 653 can adopt compressible and deformable flexible materials such as silicone, PVC (polyvinyl chloride), PU (polyurethane), and has the characteristics of thin thickness.

Referring to Figures 6B and 6C below, the sliding element 651 guides the indicator 65 to slide along the longitudinal direction of the housing (ie from the distal end to the proximal end, and vice versa). In a preferred embodiment, the first housing 61 is made of translucent or transparent material. Thus, the position of the indicator 65 relative to the first housing 61 can be used to indicate the pressure within the bladder 43 . Furthermore, when the pressure of the second chamber 607 is higher than that of the first chamber 605, the bellows 653 will inflate, meaning the airbag is flattened and under negative pressure.

In the specific embodiment disclosed in Figures 1 to 6, wherein the sliding element, the indicator, the biasing element, the valve system, the outer casing or the inner casing are arranged coaxially, that is, each element on the longitudinal axis (A axis) is are stacked. Furthermore, the direction of movement of the indicator, biasing element or deformable element is also along the A-axis. The advantage of this configuration is that the space inside the voltage stabilizing device can be effectively utilized to minimize the size of the voltage stabilizing device. Furthermore, manufacturing costs can be reduced due to significantly smaller dimensions. When in use by the user, it will not interfere with the use of other medical equipment and will provide optimum efficiency. The present disclosure also provides embodiments where all openings and valve systems are configured together, and the biasing element, indicator and outer housing are still coaxially configured. like As shown in Figures 7-8, the longitudinal axis (B-axis) of the valve system and the first opening are not parallel to the longitudinal axis (A-axis) of the indicator, biasing element or outer housing. Specifically, the A-axis and the B-axis intersect perpendicularly.

7A~7C disclose another specific embodiment of the voltage stabilizing device 7, and disclose all the features. 7B-7C further reveal the movement of the sliding element 751 and the deformable portion 7531 of the piston head 753 . Please refer to FIG. 7A for the following content. The design feature of the pressure stabilizing device 7 is that the exhaust elements (for example: the first opening 711 and the valve system 731) are concentrated in one position, and the pressure detection and adjustment system (for example: the outer casing 70 and all its internal parts) component) is configured in another place, as mentioned earlier. Specifically, a first opening 711 and a valve system 731 are provided at the distal end 701 of the outer housing 70 . A window 713 is also provided between the first opening 711 and the valve system 731 . The first opening 711 is used to connect the balloon, and the valve system 731 is used to connect the syringe. It is worth mentioning that the voltage stabilizing device 7 has only one outer shell (namely the outer shell 70). The design and configuration of the indicator 75 (piston head 753 and sliding element 751 ) and the biasing element 74 inside the outer housing 70 are similar to those in the voltage stabilizing device 1 (see FIGS. 4H-4J ).

0atm。進一步地，當平衡表壓

0atm時，大氣壓會使活塞頭753的可變形部分7531變形，使可 變形部分7531出現在窗口713中，從而可以幫助醫療專業人員確定是否可以從患者的呼吸道中取出氣管導管。 Please refer to FIGS. 7A and 7B for the following content. The actions of the indicator 75 are described in detail in FIGS. 4H and 4I. Briefly, when the pressure inside the balloon decreases, the indicator 75 moves toward the distal end 701 of the outer housing 70, and when the pressure inside the balloon increases, it drives the indicator 75 in the opposite direction (ie, toward the proximal end 703). Reference is now made to Figure 7C, which depicts the pressure stabilizing device 7 when the endotracheal tube is removed from the patient's airway. As previously disclosed in Figure 4J, when removing the endotracheal tube from the patient's airway, the user needs to confirm that the balloon is fully compressed. Thus, in order to fully compress the balloon, the medical professional may use a syringe to draw air from the balloon and first chamber 705 to reduce their volume (ie, lower the equilibrium pressure). In a preferred embodiment, when the airbag is fully compressed, the balance gauge pressure in the airbag and the first chamber 705

0 atm. Furthermore, when the balance gauge pressure

At 0 atm, the atmospheric pressure will deform the deformable portion 7531 of the piston head 753 so that the deformable portion 7531 appears in the window 713, thereby helping medical professionals determine whether the endotracheal tube can be removed from the patient's airway.

1atm時，第二閥門8171將保持在第二指示器817中。現在再請參考圖8C，穩壓裝置8的第一腔室805內的平衡壓力

1atm(較佳表壓力

0atm)用於壓縮氣囊，如圖4I中所揭示。由於穩壓裝置8內的壓力小於大氣壓，第二閥門8171的一部分會被推入並顯示在窗口813中。因此，第二閥門8171是否顯示在窗口813中可以作為信號，幫助醫療專業人員確定是否可以從患者的呼吸道中取出氣管導管。 8A~8C describe another specific embodiment of the voltage stabilizing device 7 . As revealed in Figures 7A and 8A, the main difference between the two voltage stabilizing devices is that the voltage stabilizing device 8 also includes a second indicator 817 formed by a second valve 8171 and a piston head 853, without deformable parts. The method of using the pressure stabilizing device 8 to detect and adjust the pressure or volume of the airbag is similar to the method disclosed in FIGS. 4 and 7 above. Referring now to FIGS. 8A and 8B , changes in the balance pressure in the airbag and the first chamber 805 cause the indicator 85 to move within the outer housing 80 . The position of indicator 85 relative to outer housing 80 represents the equilibrium pressure. Furthermore, when the equilibrium absolute pressure

At 1 atm, the second valve 8171 will remain in the second indicator 817. Please refer to Fig. 8C again now, the balance pressure in the first chamber 805 of pressure stabilizing device 8

1atm (preferred gauge pressure

0 atm) is used to compress the air bag, as revealed in Figure 4I. Since the pressure in the pressure stabilizing device 8 is less than the atmospheric pressure, a part of the second valve 8171 will be pushed in and displayed in the window 813 . Therefore, whether the second valve 8171 is displayed in the window 813 can be used as a signal to help the medical professional determine whether the endotracheal tube can be removed from the patient's airway.

1: voltage stabilizing device

2: Syringe

4: endotracheal tube

41: tube body

43: air bag

45: Connector

431: pipe

Claims (21)

A pressure stabilizing device for automatically adjusting and indicating the internal pressure of an airbag, which includes: a hollow shell, which includes: a first chamber; a second chamber; a valve for connecting with a syringe; a first opening for connecting with the airbag connection; a second opening; wherein the first chamber is in fluid communication with the first opening and the valve, and the second opening is used to maintain the pressure of the second chamber at atmospheric pressure; an indicator is disposed in the housing and defines the first chamber and the second chamber; and a biasing element is disposed in the second chamber and is connected to the housing and the second chamber, respectively. The indicator is connected, wherein the arrangement of the indicator and the biasing element is coaxial; wherein the arrangement is such that there is a balance between the restoring force from the biasing element and the first fluid pressure from the bladder The indicator can be caused to move longitudinally of the housing to indicate a balance pressure, wherein the restoring force of the biasing element maintains the balance pressure within a range. The pressure stabilizing device according to claim 1, wherein the housing includes a first part and a second part, and the first opening and the valve are arranged in the first part, and the second opening, the The indicator and the biasing element are disposed on the second portion. The voltage stabilizing device as recited in claim 2, wherein the first portion includes a first longitudinal axis, and the second portion includes a second longitudinal axis, and both the first longitudinal axis and the second longitudinal axis not parallel to each other. The pressure stabilizing device according to claim 2, wherein the first part further includes a second valve. The voltage stabilizing device according to claim 2, wherein a part of the second part of the housing is accommodated in the first part of the housing. The pressure stabilizing device as claimed in claim 1, wherein the casing includes a guiding element for connecting the valve and the first chamber. A pressure stabilizing device for automatically adjusting and indicating the internal pressure of an airbag, which includes: a longitudinally extending and hollow shell, which includes: a first opening for connecting with the airbag; a valve for connecting with a syringe; a second opening, which passing through the housing; and a guide element; a deformable element is disposed in the housing and used to define a first chamber and a second chamber, wherein the first chamber is guided by the guide element in fluid communication with the first opening and the valve, and the second opening for maintaining the pressure in the second chamber at atmospheric pressure; and a biasing element associated with the housing and the deformable element, respectively connection, wherein the configuration of the deformable element and the biasing element is coaxial; wherein the configuration is such that a balance between the restoring force from the biasing element and the first fluid pressure from the bladder can cause the deformable element to compress or extend indicating an equilibrium pressure, wherein the biasing element The restoring force keeps the equilibrium pressure within a certain range. The voltage stabilizing device according to claim 1 or 7, wherein the housing includes a window. A pressure stabilizing device for automatically adjusting and indicating the internal pressure of an airbag, which comprises: a longitudinally extending and hollow first housing, which includes: a first opening for connecting with the airbag; a second opening with a valve that can be connected to a syringe ; and a second housing is disposed in the first housing, which includes: a third opening passing through the first housing; an indicator is disposed in the first housing and used to define a first chamber and a second chamber, wherein the first chamber is in fluid communication with the first opening and the second opening, and the third opening is used to maintain the pressure in the second chamber at atmospheric pressure a biasing element is disposed in the first housing, and it is respectively connected with the second housing and the indicator, wherein the configuration of the indicator and the biasing element is coaxial; wherein the configured such that a balance between a restoring force from the biasing element and a first fluid pressure from the bladder causes the indicator to move to indicate a balanced pressure, wherein the restoring force of the biasing element causes the The balance pressure is kept within a certain range. The voltage stabilizing device according to claim 1, wherein the indicator comprises a deformable element. The voltage stabilizing device as claimed in claim 7, 9 or 10, wherein the deformable element is rubber, membrane, balloon or stretchable bag. The pressure stabilizing device according to claim 7, 9 or 10, wherein when the pressure of the first fluid is higher than the restoring force, the deformable element is in a compressed state. The pressure stabilizing device according to claim 7, 9 or 10, wherein when the first fluid pressure is higher than the restoring force, the deformable element is in an extended state. The pressure stabilizing device according to claim 7, 9 or 10, wherein when the pressure of the first fluid is higher than the restoring force, the volume of the first chamber increases. The pressure stabilizing device according to claim 7, 9 or 10, wherein when the pressure of the first fluid is higher than the restoring force, the volume of the first chamber decreases. The pressure stabilizing device of claim 7, 9 or 10, wherein said deformable element deforms and said biasing element has a longest longitudinal length when said first fluid pressure is at said atmospheric pressure. The voltage stabilizing device as claimed in claim 1, 7 or 9, wherein the housing includes fixing elements for anchoring the voltage stabilizing device on the pipe. The voltage stabilizing device as claimed in item 1, 7 or 9, wherein said range is 20-30 cmH ₂ O or 40-60 cmH ₂ O. The voltage stabilizing device as claimed in claim 1, 7 or 9, wherein the biasing element is a spring. The voltage stabilizing device according to claim 19, wherein the k value of the bias element is 1.5 to 2.5 g/mm. The pressure stabilizing device according to claim 1, 7 or 9, wherein when the balance pressure is not within the range, the syringe is used to adjust the balance pressure so that the balance pressure remains within the range Inside.

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