Ventilator mask and system

This application claims priority to US Patent Preliminary Application No. 60 / 505,718, filed September 25, 2003. The contents of this document are incorporated herein by reference in their entirety for reference.

The present invention relates to a respiratory tract, for example, continuous positive airway pressure (for example, comprising a mask and an airflow generator, the airflow generator being attachable to a mask wearer). "CPAP") It is about the system. In one embodiment, the invention provides a CPAP system of the type in which an airflow generator is mounted on a mask. In other embodiments, the airflow generator can be placed on the wearer's body, such as on the arms, legs, chest and waist, and by using a short air supply tube, the mask. Can be connected to the air flow generation source.

CPAP treatment is commonly used to treat respiratory disorders such as obstructive sleep apnea syndrome. When performing CPAP treatment, a mask is typically worn in a sealed manner over the patient's nose and / or mouth area to deliver pressurized air to a chamber formed inside the mask. In prior art systems, air is supplied to the mask, typically by an airflow generator located near the patient's bed. In this case, an air supply tube is required to supply the air generated by the air flow generation source to the mask.

There are two main causes of instability in the mask system during use and sleep. Normal movement of the patient can lead to instability. For example, if the patient rolls sideways, the mask can collide with bed components. Another concern is the use of air supply tubes to make connections to devices located far from the patient, in which case there is a so-called "tube pull". The pulling of the tube means that a pulling force is applied to the air supply tube mounted on the back or side surface of the bed. The pulling of the tube is caused and complicated by the movement of the wearer. Pulling on the tube causes relative movement between the mask seal and the patient's face during CPAP treatment, causing leakage and discomfort.

Another concern is the long air supply tube (often about 2 m or more). Therefore, when the pressurized air is supplied from the air flow generation source to the mask, the response time is delayed and the rise time is required. Due to the diameter and length of the tube, the flow impedance increases and / or the pressure drop increases. For this reason, a larger blower motor is needed to compensate for the pressure drop along the air supply tube.

Patent Documents 1 to 3 describe the safety when applying a mask.

<p num="0007"><patcit num="1"><text>U.S. Pat. No. 4,590,951</text></patcit><patcit num="2"><text>U.S. Pat. No. 5,372,130</text></patcit><patcit num="3"><text>U.S. Pat. No. 6,435,184</text></patcit></p>

<p num="0008"> From the point of view of the present invention, problems in the prior art are solved, for example, by reducing or avoiding the risk of pulling the tube during CPAP treatment.</p><p num="0009"> Another aspect of the present invention is to increase the degree of freedom of movement of the wearer in the bed while achieving both sealing performance and comfort.</p><p num="0010"> Another aspect of the present invention is to reduce or eliminate delays in response time / rise time in supplying pressurized air from the airflow source to the mask.</p>

<p num="0011"> In one embodiment, the respiratory system or CPAP system comprises a mask and an airflow generator, both of which are attached to or on the wearer. To. In one embodiment, the mask is placed on the patient's face and the airflow generator can be attached to the wearer's body. The air flow generation source can be attached directly to the mask.</p><p num="0012"> In one embodiment, the CPAP system comprises a face mask and an airflow generator, the airflow generator being mounted on the face mask.</p><p num="0013"> In a further embodiment, the respiratory system or CPAP system (i) Equipped with a face mask that is placed over an area of the wearer's face. (1) With shell; (2) A cushion attached to the shell so that the mask can be hermetically connected to the wearer's face, and a cushion that forms a chamber between the shell and the wearer's face. When; (3) With an introduction port provided in the shell to receive the flow of breathable gas; With (ii) The system is further equipped with an air flow generator, which is mounted on the mask and in the chamber 2-40 cmH.₂It is supposed to be able to generate a pressure of O.</p><p num="0014"> In embodiments, the respiratory system or CPAP system comprises an airflow generation source that can be located in close proximity to the wearer. As a result, the length of the air supply tube can be kept within 1.5 m.</p><p num="0015"> In one embodiment, the respiratory system or CPAP system A face mask with an introduction port and An air flow generation source with a lead port and With at least one air supply tube for supplying breathable gas from the outlet port to the inlet port, Equipped with At least one air supply tube is supposed to be shorter than 1.5m. At least one air supply tube can consist of two or more air supply tubes and is generally shorter than 1.5m.</p><p num="0016"> In a further embodiment, the respiratory system or CPAP system (i) Equipped with a face mask, this mask (1) With shell; (2) A cushion attached to the shell so that the mask can be hermetically connected to the wearer's face, and a cushion that forms a chamber between the shell and the wearer's face. When; (3) With an introduction port provided in the shell to receive the flow of breathable gas; With (ii) The system also has an airflow generator; (iii) With an air supply tube that is within 1.5 m in length; Equipped with An air supply tube connects the inlet to the airflow generator, which provides 2-40 cmH into the chamber by supplying breathable gas from the airflow generator towards the inlet.₂A pressure of O is generated.</p>

<figref num="1">It is a perspective view which shows the CPAP system by one Embodiment of this invention.</figref><figref num="2">It is an exploded view which shows the CPAP system of FIG.</figref><figref num="3">It is a front view which shows the inner surface of the CPAP system of FIG.</figref><figref num="4">It is a rear view which shows the outer surface of the CPAP system of FIG.</figref><figref num="5">It is a right side view which shows the CPAP system of FIG.</figref><figref num="6">It is a top view which shows the CPAP system of FIG.</figref><figref num="7">It is a bottom view which shows the CPAP system of FIG.</figref><figref num="8">It is a bottom view which shows the CPAP system by another embodiment of this invention.</figref><figref num="9A">It is a figure which shows the wearer of the CPAP system of FIG.</figref><figref num="9B">It is a figure which shows the alternative embodiment of this invention.</figref><figref num="10A">It is a figure which shows the wearer of the CPAP system by another embodiment of this invention.</figref><figref num="10B">It is a figure which shows schematic the air flow generation source and the battery pack about CPAP by one Embodiment of this invention.</figref><figref num="11A">It is a figure which shows the wearer of the CPAP system by another embodiment of this invention.</figref><figref num="11B">It is a figure which shows the battery pack and the strap which concerns on CPAP by one Embodiment of this invention.</figref>

Other viewpoints, advantages and features of the present invention are described below and will be understood by those skilled in the art by disclosure of the present invention. The inventions disclosed herein do not limit various specific combinations and various arbitrary combinations with respect to different perspectives, different advantages and different features. It is assumed that different combinations with respect to the various viewpoints, different advantages and different features disclosed will be included within the present invention.

FIG. 1 is a perspective view showing a CPAP system according to an embodiment of the present invention.

FIG. 2 is an exploded view showing the CPAP system of FIG.

FIG. 3 is a front view showing the inner surface of the CPAP system of FIG.

FIG. 4 is a rear view showing the outer surface of the CPAP system of FIG.

FIG. 5 is a right side view showing the CPAP system of FIG.

FIG. 6 is a plan view showing the CPAP system of FIG.

FIG. 7 is a bottom view showing the CPAP system of FIG.

FIG. 8 is a bottom view showing a CPAP system according to another embodiment of the present invention.

FIG. 9A is a diagram showing a wearer of the CPAP system of FIG.

FIG. 9B is a diagram showing an alternative embodiment of the present invention. FIG. 10A is a diagram showing a wearer of a CPAP system according to another embodiment of the present invention.

FIG. 10B is a diagram schematically showing an air flow generation source and a battery pack for CPAP according to an embodiment of the present invention.

FIG. 11A is a diagram showing a wearer of a CPAP system according to another embodiment of the present invention.

FIG. 11B is a diagram showing a battery pack and strap for CPAP according to an embodiment of the present invention.

The CPAP system comprises a mask and an air flow generator, which is provided to the wearer of the mask. In one embodiment, the airflow generator is attachable to the wearer's body (including the wearer's clothing). In other embodiments, the airflow generator is attached to the mask.

1 to 11B show some embodiments of the CPAP system according to the invention.

As shown in FIG. 1, the CPAP system 10 includes a mask 60. The mask 60 includes a cushion 30 and a shell 46, which forms an air chamber that communicates with the wearer's airways. In this example, the mask 60 covers at least the area between the wearer's mouth and nose. However, the mask 60 can also be a nasal mask, in which case it covers, for example, only the nasal area or only the mouth area. In either case, the mask preferably does not cover the wearer's eyes or obstruct the field of vision. The mask is CO₂ It may include a vent hole 61 for expelling the gas and one or more introduction ports 47 for use when introducing supplemental gas, such as oxygen, into the air chamber. Vent hole 61 is controllable CO₂ Can be covered with a suitable insert 63 or the like so that the can be discharged. Inserts are disclosed in US Pat. No. 6,561,190 and US Pat. No. 6,561,191 by ResMed. The contents of these documents are incorporated herein by reference.

The mask cushion 30 is preferably made of a soft material (eg, a rubber material such as a silicone elastic body) to form a hermetic connection to the wearer's face. As a result, an air chamber can be formed between the wearer's face and the mask 60. The shell can be made of relatively hard plastic. However, the shell can be made of the same material as the cushion 30 for some applications. An example of cushion 30 is disclosed, for example, in US Pat. No. 6,513,526 by ResMed Limited. The contents of this document are incorporated herein by reference in their entirety for reference. An example of a commercially available mask 60 is the Mirage® Full Face Mask Series II by ResMed Limited (no fine adjustments as described in detail below are taken into account).

A headgear connector 50 is attached to the shell 46. The headgear connector is configured to be able to receive a headgear strap for fixing the CPAP system 10 to the wearer's head (fixing strap 55 is shown in FIGS. 9 and 10A). An extension 72 is attached to the shell 46. The extension 72 is provided with an overall elastic pad (not shown) that allows it to engage with the wearer's forehead and may provide additional stability. It is supposed to be. Straps can be provided on each connector 50 of the extension 72 to allow contact with the wearer's head. Alternatively or additionally, the extension 72 may be provided with a strap connector 50a such that the strap extends over the entire head of the wearer, as shown in FIGS. 9 and 10A. ..

An air chamber formed between the wearer's face and the interior of the mask 60 receives breathable gas (eg, air) through the air inlet port 56 (see FIG. 2). The air inlet port 56 is configured to be located in the immediate vicinity (eg, directly above) the wearer's mouth / nose area. The respirable gas is supplied by the air flow generation source 20. In one embodiment, the airflow supplied by the airflow generation source 20 is 2-40 cmH in the air chamber.₂In the range of O, for example, 10 ~ 28cmH₂O or 15 ~ 20cmH₂In the range of O, or 10 cmH₂It forms a relatively constant single or variable pressure such as O.

As shown in FIG. 2, the air flow generation source 20 includes, for example, a first portion 90 and a second portion 80. These portions 80,90 are connected to each other, for example, by screws 130 through holes 134,136. This forms a housing for the impeller 120 and the motor 100. These parts 80,90 can be formed from a variety of materials, such as cured resin materials, metals (eg aluminum), eg polyolefins (such as polyethylene or polypropylene), polycarbonates and acrylonitrile butadiene styrene polymers (" It can be formed from polymers such as ABS ).

The motor 100 drives the impeller 120. Electric power is supplied to the motor 100 via the electric cord 110. The motor 100 is fixed in the impeller housing by tightening the screw 132. Examples of electrical motors include Servo Magnetics Inc. of California, USA. There are small burette motors, such as those marketed by the company. However, various types of motors can be used. For example, a pneumatically driven motor can be used. In this case, a small airline is used as an energy source instead of an electric pulse. The motor assembly can be an assembly using multiple motors, an assembly in which multiple impellers are driven by a single motor, an assembly with double-sided impellers, or an assembly. A configuration other than these can be used. Another possibility is to disperse multiple systems that can provide a given air pressure. In another variant, additional motor impeller assemblies can be used to change the responsiveness to detection parameters such as irritation and / or leakage problems, for example if an inflatable cuff is provided. it can. By using a separate motor impeller, it is possible to control the position of the mask with respect to the face or the profile of the cushion seal.

An example of an impeller is the S6 CPAP impeller by ResMed. However, various impellers can be used, such as axial fans, radial fans, centrifugal fans, etc., and further to provide the desired distribution of gases such as air. Any new technology can be used.

The electrical cord 110 can receive power from any suitable power source, such as a wall outlet, a wall-mounted transformer, a battery pack, or other power storage medium. In one embodiment, the electrical cord 110 is a sensor cable. This allows sensors that can be installed inside the mask (eg CO₂Sensor, O₂Data received from sensors, humidity sensors, pressure sensors, flow rate sensors, and / or temperature sensors) can be recorded and / or adjusted. In one embodiment, sensor observations are made using infrared technology or radio frequency technology. Control boxes can be provided so that, for example, the motor speed can be adjusted, for example processing between two levels can be performed, or other parameters can be adjusted in relation to the information received by the sensor. In other embodiments, by detecting a leak, the motor speed can be adjusted, thereby adjusting the supply pressure or supply flow rate.

The electrical cord 110 can be connected to a small controller chip (not shown) that contains an electrical transformer that can be plugged into a power terminal. This increases flexibility, increases the wearer's freedom of movement, and increases travel versatility. In addition, the number of members at the mask interface is small, the overall size of the system is small, and the potential stability is high. The system can process between two levels. Alternatively, it can generally be used in respiratory applications. In that case, for example, the magnitude of the pressurized air changes. The system can also provide faster response and faster rise time, eliminating or at least reducing delays associated with air supply tubes, typically having a length of 2 m or more. can do. The system is easier to use from the surgeon's, distributor's and clinician's point of view because it attaches a single member to the wearer rather than a large number of members.

In other embodiments, the strap adjustment points can be changed. That is, the built-in detection can be used to adjust the degree of fit of the mask to the face. For example, if there is a leak with respect to the mask, a sensor such as the pressure transducer 67 (Fig. 4) can generate a signal indicating the leak in the mask to change the pressure of the airflow generator. it can. Also, in embodiments where the air sac or part of the cuff or mask seal has been modified such that the seal profile within an area may be modified until the leak is resolved, the sensor will refer to the control box. The leak can be dealt with by providing feedback and driving the motor in association with this feedback. See, for example, US Pat. No. 10,332,578, filed December 19, 2002, by ResMed. The contents of this document are incorporated herein by reference in their entirety for reference.

Flow detection or pressure detection in the mask system improves response time, and having the motor impeller assembly mounted directly within the mask system responds to pressure and flow changes. It means that the time is very quick. Therefore, the synchrony of the gas supplied to the wearer is improved. Currently (ie, in the prior art), the airflow generator will allow the patient to breathe correctly, using techniques such as using a pressure sensor attached to the airflow generator. It is necessary to substantially predict whether the patient's breathing is delayed or there is some delay in the patient's breathing. In contrast, in one aspect of this embodiment of the invention, the mask system can react very quickly. This allows the air flow to be supplied to the patient in a very well synchronized manner. This is especially true when treating a patient who is breathing inadequately and by supplying the airflow from the airflow source in a very well synchronized manner. It is a key point.

The airflow generation source 20, for example, has a second portion 80 that penetrates the mask 60, for example, through a through hole 70 (only two through holes are shown) and a hole 136 (opposite to the screw 130). It is attached by using four screws 140 (only two screws are shown in Figure 2) screwed into the side surface (the side surface is shown). Of course, various other techniques can be used to mount the airflow generator 20 on the full face mask 60. For example, various methods can be used, such as using an adhesive, using melt welding, or integrally molding the shell 46 and the second portion 80 by injection molding. In still other embodiments, the airflow generation source 20 can be easily removed from the mask. Thereby, for example, cleaning can be easily performed. One or more quick attachment / detachment clips can be used for this purpose.

In one embodiment, in embodiments such as those shown in FIG. 2, a perforated screen 40 (eg, a perforated aluminum screen) is located between the introduction port 56 and the airflow generation source 20. Such a perforated metal screen) is placed. This screen includes the outlet port 85 (FIG. 3) (the air outlet port 85 is shown through screen 40 as being located on the other side of the screen 40 in FIG. 3) and the airflow generator 20. To prevent foreign matter that may be introduced from the airflow generation source from reaching the wearer's mouth and face areas. The perforated screen 40 also ensures that the wearer's tongue and other parts, which are larger than the hole diameter, cannot come into contact with the impeller 120. Examples of the perforated screen 40 are, for example, a mesh or a thin plate in which a large number of small holes are formed. This configuration also ensures that the wearer is not injured by any failure of the motor or impeller, such as breakage.

3 to 7 show various CPAP masks 10 shown in FIGS. 1 and 2. Another embodiment is shown in FIG. In FIG. 8, the filter 128 is located in front of the air intake opening 125 (see air intake opening 125 in FIG. 7). The filter 128 can be, for example, a filter (ie, a dust filter) to prevent dust from entering the impeller system or into the perforated screen. Although the perforated screen cannot prevent dust from entering the impeller system, the perforated screen cannot, for example, bring the wearer's finger into contact with the impeller 120. It is valid. In addition, the perforated screen prevents larger particles from entering the impeller system. In one embodiment, the CPAP system and / or airflow generator comprises a dust filter or an antibacterial filter. In a further embodiment, the CPAP system and / or airflow generator is not equipped with a dust filter or antibacterial filter.

As shown in FIG. 9A, the CPAP system of FIG. 1 is attached on the face of wearer 1 by a strap 55. Electric power is supplied to the air flow generation source 20 by the battery pack 150 via the electric cord 110. The battery pack 150 is attached to the wearer's body via a strap 160. The advantage of using a battery pack as a power source is, for example, to increase the mobility of the wearer. In another embodiment, as shown in FIG. 9B, power to the airflow generation source can be supplied by a transformer power pack 150'plugged into the wall outlet 163.

FIG. 10A shows an embodiment in which the impeller system 20A is not mounted directly on the mask 60A, but the impeller system 20A is mounted to the wearer's body via a strap 160. Is shown. The air outlet of the air flow generation source 20A is attached to the air supply tube 65. Then, the air supply tube 65 is attached to the air introduction port of the full face mask 60A via the socket 64 and the connecting tube 62. In one embodiment, the air supply tube 65 is a tube shorter than 1.5 m, for example a 1.0 m tube or a 0.5 m tube. The air supply tube can be a tube of any diameter. Alternatively, the air supply tube can consist of multiple air tubes with a small profile and / or kink resistance. In this regard, ResMed filed on August 12, 2003. It is described in U.S. Patent Application No. 60 / 494,119 by the company. The contents of this document are incorporated herein by reference in their entirety for reference. Power is supplied from the battery pack 150 to the airflow generation source 20A via the power cord 110A. Power packs or airflow generators can also be integrated as an assembly.

In one embodiment, the airflow generator 20A and battery pack 150 are attached to the strap 160 using clips 162A, 162B (see FIG. 10B). Of course, this embodiment is not limited to such mounting systems, with one or both of the airflow generator and the battery pack being the wearer's body (via any suitable means). Can be attached to any suitable part (including clothing). For example, as shown in FIGS. 11A and 11B, the airflow generator 20A can also be attached to the wearer's arm via means such as Velcro® 160A. Motor assemblies, including impellers, can also be attached to other parts of the wearer's body, such as the chest and shoulders, for example via straps.

In yet another variant (not shown), the motor assembly can be attached, installed, or combined with the headgear system while shortening the tube that extends to the mask. The headgear system can act in the form of a vibration damper. The motor inevitably vibrates during operation due to imbalance. By not transmitting this vibration to the wearer, annoyance and noise can be reduced. Due to the vibration sensitivity of the head, it is preferable to provide vibration isolation in some way with respect to the motor and / or impeller. A damper system (damping system) can be used. For example, the use of viscoelastic and / or soft foam "cushions" between the head and the airflow generator can provide several advantages.

From another point of view, the motor may be provided with a heat radiating plate. This allows the air that the patient is breathing to be heated. This can improve breathing comfort. From an additional point of view, the temperature of the breathing air can be controlled based on ambient conditions, for example by using a feedback loop. These perspectives can be incorporated as part of any of the various embodiments described above.

Although the invention has been described with reference to various exemplary embodiments, it will be understood that the above description is not intended to limit the invention. Various modifications can be made without departing from the scope and spirit of the present invention. For example, although the various embodiments described above have been described as relating to CPAP applications, the various features defined in those embodiments may also apply in the areas of general ventilation, ventilation and respiratory organs. It will be understood that it is a thing. In addition, the system can be used for children, adults and people of all ages.

1 wearer 10 CPAP system (respiratory system) 30 cushion 40 perforated screen 46 shell 47 Introductory port 55 strap 56 Air inlet port 60 mask 100 motor 110 electrical cord 120 impeller 125 Air intake opening 150 battery pack 160 strap