PERSONAL EXHALED AIR REMOVAL SYSTEM AND METHOD

20230218841 · 2023-07-13

    Inventors

    Cpc classification

    International classification

    Abstract

    A personal exhaled air removal (PEAR) system for removing/evacuating exhaled air from a vicinity of a patient is designed to remove the exhaled air during an exhalation cycle of a patient. The system is synchronized with a patient's breathing cycle for activating suction of exhaled air via at least one suction inlet, and the suction inlet is adjacent to the patient, possibly attached to the patient via an interface.

    Claims

    1.-43. (canceled)

    44. A personal exhaled air removal (PEAR) system for removing/evacuating exhaled air from a vicinity of a patient, wherein the evacuation of the exhaled air occurs during an exhalation cycle of a patient, and the system being synchronized with a patient's breathing cycle for activating suction of exhaled air via at least one suction inlet that is adjacent to the patient, wherein the PEAR system comprising at least one vacuum tank for applying suction when suction is activated, and wherein prior to each exhalation phase negative pressure below pressure in an ambient environment is re-created within the at least one vacuum tank, and wherein the system comprises a valve that: is controllable to open during an exhalation cycle of a patient in order to permit evacuation of exhaled air towards and into the at least one vacuum tank, and is controllable to close when an exhalation cycle of a patient ends in order to buildup the re-creation of the negative pressure within the at least one vacuum tank.

    45. The PEAR system of claim 44, wherein evacuation of exhaled air during a breathing cycle of a patient starts substantially at an end of a prior inspiration of the patient in order to substantially reach peak capacity of air removal as expiration begins.

    46. The PEAR system of claim 44, wherein the removing of exhaled air is at a flow rate of above about 1 liter per second.

    47. The PEAR system of claim 46, wherein the removing of the exhaled air occurs substantially only during an exhalation cycle of a patient.

    48. The PEAR system of claim 46 and comprising a facemask attachable to the patient and the at least one suction inlet being in fluid communication with an interior of the facemask to evacuate gaseous from within the facemask during use.

    49. The PEAR system of claim 48 and being used in conjunction with a supportive measure providing gaseous for aiding an inhalation phase of the patient, wherein said supportive measure is an integral part of the PEAR system or auxiliary to the PEAR system, and wherein the supportive measure continuously provides gaseous towards the patient.

    50. The PEAR system of claim 49, wherein the supportive measure is also arranged to communicate with the patient at the facemask, via an inlet formed in the facemask.

    51. The PEAR system of claim 49 and being arranged to direct gaseous applied by the supportive measure towards the patient's mouth and/or nose at least when the facemask is attached to the patient's face.

    52. The PEAR system of claim 49, wherein the supportive measure is a respiratory support device such as a high flow oxygen (HFO) device, a high flow nasal cannula (HFNC) device and/or a drug delivery device such as a nebulizer used for administering medications to a patient.

    53. The PEAR system of claim 44 and comprising a sensor arranged to detect the patient's breathing cycle in order to control the opening and closing of the valve.

    54. The PEAR system of claim 53, wherein the sensor a temperature sensor.

    55. A method for removing/evacuating exhaled air from a vicinity of a patient comprising the steps of: providing a personal exhaled air removal (PEAR) system comprising at least one suction inlet, placing the at least one suction inlet adjacent to the patient, providing a supportive measure for aiding in an inhalation phase of the patient, and using the PEAR system and the supportive measure in conjunction while activating suction by the least one suction inlet of the PEAR system of exhaled air of the patient according to breathing patterns of the patient, wherein the PEAR system comprising at least one vacuum tank for applying suction when suction is activated, and wherein prior to each exhalation phase negative pressure below pressure in an ambient environment is re-created within the at least one vacuum tank, and wherein the system comprises a valve that: is controllable to open during an exhalation cycle of the patient in order to permit evacuation of exhaled air towards and into the at least one vacuum tank, and is controllable to close when an exhalation cycle of the patient ends in order to buildup negative pressure within the at least one vacuum tank.

    56. The method of claim 55, wherein the supportive measure aiding the patient lowers its support to the patient during operation of suction by the PEAR system.

    57. The method of claim 56, wherein evacuation of exhaled air during a breathing cycle of a patient starts substantially at an end of a prior inspiration of the patient in order to substantially reach peak capacity of air removal as expiration begins.

    58. The method of claim 56, wherein the removing of exhaled air via the least one suction inlet is at a flow rate of above about 1 liter per second.

    59. A personal exhaled air removal (PEAR) system for removing/evacuating exhaled air from a vicinity of a patient and comprising least one suction inlet, wherein the evacuation of exhaled air during a breathing cycle of a patient starts substantially at an end of a prior inspiration of the patient in order to substantially reach peak capacity of air removal as expiration begins, and the removing of the exhaled air occurs during an exhalation cycle of a patient, and is at a rate of above about 1 liter per second, wherein the PEAR system comprising at least one vacuum tank for applying suction when suction is activated, and wherein prior to each exhalation phase negative pressure below pressure in an ambient environment is re-created within the at least one vacuum tank, and wherein the system comprises a valve that is controllable to close when an exhalation cycle of a patient ends in order to buildup the re-creation of the negative pressure within the at least one vacuum tank.

    60. The PEAR system of claim 59, wherein evacuation of exhaled air during a breathing cycle of a patient starts substantially at an end of a prior inspiration of the patient in order to substantially reach peak capacity of air removal as expiration begins.

    61. The PEAR system of claim 59, wherein the valve is controllable to open during an exhalation cycle of a patient in order to permit evacuation of exhaled air towards and into the at least one vacuum tank.

    62. The PEAR system of claim 59, wherein the removing of the exhaled air occurs substantially only during an exhalation cycle of a patient.

    63. The PEAR system of claim 59 and comprising a facemask attachable to the patient and the at least one suction inlet being in fluid communication with an interior of the facemask to evacuate gaseous from within the facemask during use.

    Description

    BRIEF DESCRIPTION OF THE FIGURES

    [0085] Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative, rather than restrictive. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

    [0086] FIG. 1 schematically shows an embodiment of a personal exhaled air removal (PEAR) system of the present invention;

    [0087] FIG. 2 schematically shows another embodiment of a personal exhaled air removal (PEAR) system of the present invention;

    [0088] FIGS. 3A and 3B schematically show yet another embodiment of a personal exhaled air removal (PEAR) system of the present invention;

    [0089] FIGS. 4 and 5 schematically show yet further embodiments of personal exhaled air removal (PEAR) systems of the present invention;

    [0090] FIG. 6 schematically shows a graph illustrating breathes of a patient;

    [0091] FIG. 7 schematically shows a diagram illustrating components of an embodiment of a PEAR system;

    [0092] FIGS. 8A and 8B schematically show graphs illustrating operations or various personal exhaled air removal (PEAR) system embodiments during inhalation and exhalations cycles; and

    [0093] FIG. 9 schematically shows a mask of a personal exhaled air removal (PEAR) system in accordance with various embodiments of the present invention.

    [0094] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated within the figures to indicate like elements.

    DETAILED DESCRIPTION

    [0095] Attention is first drawn to FIG. 1 schematically showing one possible embodiment of a personal exhaled air removal (PEAR) system 10 of the present invention.

    [0096] PEAR systems according to various embodiments of the present invention may be used in conjunction with supportive measure respiratory devices. Here a delivery device 11 of such a supportive measure is illustrated possibly delivering substances from the supportive measure respiratory device.

    [0097] Certain embodiments of PEAR systems may be arranged to integrally include a delivery device 11 and/or a respiratory device suitable for delivering substances via such delivery device 11 to a patient. However other PEAR system embodiments may be arranged to be used with delivery devices 11 and/or respiratory devices delivering substances via such delivery devices that may be auxiliary and non-integral to the PEAR system.

    [0098] Such respiratory devices suitable for delivering substances to a patient, in non-binding examples, may include high-flow oxygen (UFO) devices, devices suitable for providing medications via nebulizers (or the like). In this example, delivery device 11 is embodied as including an optional nasal cannula for delivering supplemental oxygen and/or medication to the patient.

    [0099] It is noted that while FIG. 1 illustrates presence of a delivery device 11 hinting to presence of a respiratory device (not shown), PEAR embodiments shown in other figures, although not illustrating a delivery device, can be understood to be possibly suitable for use with such delivery devices and/or respiratory devices.

    [0100] Powering of suction of a patient's exhaled air by PEAR system embodiments may be achieved by various means. In one example, an embodiment of a PEAR system may be coupled to a suction system typically available in medical facilities, such as in hospitals (or the like). Such suction system may be powered by a central pump station and typically may provide wall outlets o which various medical devices requiring suction may be coupled.

    [0101] In cases where reliance solely on available suction systems in a medical facility may not be sufficient for effectively evacuating exhaled air of a patient, additional suction utilities may be provided within at least certain PEAR system embodiments.

    [0102] Attention is drawn to FIG. 7 illustrating an embodiment of a PEAR system 1005 that includes a suction tank 50 for assisting in the drawing of air exhaled by a patient.

    [0103] Negative pressure below pressure present in the ambient environment may be formed within suction tank 50 by a pressure pump 53 in communication with the suction tank via a one-way valve 1. The pressure pump 53 may be arranged to draw air out of the suction tank and by that reduce the pressure within the suction tank.

    [0104] In a non-binding example, the pressure within suction tank 50 may be formed by pressure pump 53 to be at about 0.2 to about 0.5 bar below the pressure in the ambient environment (e.g. about 0.5 to about 0.8 bar where pressure in the ambient environment is atmospheric pressure, i.e. about 1 bar).

    [0105] An available suction system in a medical facility where the PEAR system is located, may optionally also be coupled to the suction tank 50 via a one-way valve 1 that permits drawing of air out of the suction tank only.

    [0106] An electric valve 51, possibly controllable by sensors monitoring a breathing phase of a patient, may be arranged to open a path leading towards the suction tank in order to permit suction of exhaled air via an inlet nozzle 52 of the system that is located adjacent to and/or in communication with the patient's mouth. and/or nostrils.

    [0107] An internal volume of the suction tank 50 may be suited to the amount of exhaled. air that the PEAR system may be expected to evacuate in each exhalation phase of the patient. After being opened to evacuate an exhaled breath of a patient, the electric valve 51 may be triggered to close so that a subsequent buildup of negative pressure within the suction tank may initiate. Upon detection of a subsequent exhalation of the patient, the valve may be re-opened to evacuate the next exhalation, and this process may continue as long as the patient is connected to the PEAR system.

    [0108] Attention is drawn back to FIG. 1. PEAR system 10 in this example includes an optional patient interface 12 formed of two bars 121, 122, that extends laterally along the patient's face. The upper bar 121 is here located above the eyes of the patient, and the lower bar 122 here extends along the patient's upper lip between his/her nose and mouth.

    [0109] In this example, the bars 121, 122 are interconnected by hinges 123 located on both sides of the patient's head adjacent his/her ears. The hinges may aid in setting an angle between the bars and by that optimize adjustment of patient interface 12 to a patient's face.

    [0110] The enlarged section at the lower right hand side of the figure reveals an embodiment of a suction member 14 of the PEAR system, here located along the lower bar of the patient interface. The additional enlarged section at the lower left hand side of the figure reveals a possible tube like formation of the suction member 14, including openings 141 through the tube wall, via which exhaled air of the patient may be sucked away and removed from a vicinity of the patient, and preferably removed to a location outside of a room within a dwelling where the patient in located.

    [0111] Attention is drawn to FIG. 2 illustrating an embodiment of a PEAR system 100 generally similar to that in FIG. 1, here shown including strap members 124 looping around each one of the ears of the patient to securely attach the PAER's patient interface 12 to the patient's face.

    [0112] Attention is drawn to FIGS. 3A and 3B illustrating two PEAR system embodiments 1001, 1002 here exemplified located upon chest regions of patients. Both system 1001, 1002 include tube like suction members 14 with openings for sucking exhaled air away from a vicinity of the patient.

    [0113] While the suction members in system 1001 extend both along the chest of the patient, in system 1002 one of the suction members, here more distal to the patient's head, can be seen being lifted above the patient's chest by a flap like structure 142 of the patient interface.

    [0114] Both PEAR systems 1001, 1002 illustrate use of an evacuation conduit 18 for evacuating the sucked exhaled air of the patient away from the patient, preferably to outside of a room where the patient is located.

    [0115] PEAR systems 1001, 1002 are here formed as “apron” like members overlying the patient's chest. In certain cases, such PEAR systems may include a blower 13 arranged to form an ‘air curtain’ 17 of emitted air flow towards the “apron” like members, where same may be sucked away and removed from a vicinity of the patient—thus assisting in preventing a patient's exhaled air from spreading within a dwelling where the patient is located.

    [0116] Attention is drawn to FIGS. 4A and 4B illustrating an embodiment of a

    [0117] PEAR system 1003 (see fully in FIG. 4B), which includes a patient interface 12 (see in isolation in FIG. 4A), Patient interface 12 in this example is seen including an H shape with a central section 125 that extends laterally between the nose and mouth of the patient.

    [0118] PEAR system 1003 in this example includes a so-called open “duck beak” formation 1400 that extends away from central section 125 of the patient interface. Formation 1400 acts to urge exhaled air from the patient's mouth to be directed downwards while exhaled air from the nose is directed upwards (relative to the mouth).

    [0119] Formation 1400 may include tube like suction members for assisting in suction and removal of exhaled air by the patient.

    [0120] Attention is drawn to FIG. 5 illustrating a further embodiment of a PEAR system 1004. In this example, a patient interface 12 of the PEAR system is seen supporting a suction member 14 in front of the face of the patient to suck exhaled air by the patient.

    [0121] Attention is drawn to FIG. 6 illustrating at its lower area a graph of recorded patient breaths. Such recording of patient breathes may typically be done in various techniques and using various sensors. In this example, such sensor may be an accelerometer attached to a patient's chest. The y-axis shows displacement of the sensor (units of distance) and the x-axis shows time in second intervals. A patient's inhaled and exhaled volumes may be seen here corresponding to sensor displacement, and transformation of such displacement to volume may be determined according to various functions/correlations.

    [0122] Breathing cycles in this figure are designated by a horizontal bar and a number indicated below each bar. The first breathing cycle (tagged ‘1’) in this example is at the left hand side of the figure. The cycle starts from a point on the y-axis termed: EEx, where EEx is the point on the trajectory taken by the sensor where the sensor is at the end of “normal” expiration. “Normal” in this context means a resting breathing cycle (e.g. without sighs, coughs, sneezes, etc.).

    [0123] The inspiratory phase in this example lasts about 1 second (i.e. from about second 2 to 3 along the x-axis) to reach point I.sub.1 where it is followed by an expiratory phase terminating at point E.sub.1 (in this example at about second 4). Breathing cycle 2 is a bit greater than breathing cycle 11, which means that inspiration is deeper (sensor is more displaced) and expiration is greater, reaching point E.sub.2 which also is similar to EEx.

    [0124] Cycle 3 in this example is generally a normal cycle (generally similar to cycle 1), and cycle 4 shows a greater than normal inspiration, perhaps in a case of a deep sigh or prior to a sneeze, and the expiration of this cycle terminates at point E.sub.4 and is also greater than normal. Cycle 5 in this example is again a generally normal breathing cycle, and cycle 6 shows a deep inspiration followed by a large volume expiration. The latter exhaled volume can occur during, for example, a prolonged cough, where intense expiration displaces the sensor to a place which is below EEx. Expiration terminates at a point E.sub.6.

    [0125] Recording the trajectory/indication of the sensor may facilitate in monitoring a patient, e.g. by a physician treating such patient, and by that possibly learning the breathing pattern of the patient, In particular, rate of breathing, variation of depth of breaths, the ratio between duration of inspiration and expiration, number of coughs, sighs, sneezes in a tune interval (and the like), may be learnt. Therefore, in certain embodiments, such breathing data may be recorded and visually presented to a physician treating the patient.

    [0126] In an aspect of the present invention, the pattern of breathing may be used to provide so-called “landmarks” that may be taken into consideration in activation of suction in at least certain PEAR system embodiments. The upper area of the graph illustrates possible suction actions that may be activated by an embodiment of a PEAR system in response to a sensed breathing pattern of a patient.

    [0127] For example, by using breathing cycle data (as in FIG. 6 or the like), prediction of magnitude of the expiration of a breath may be taken into account in the activation of an embodiment of a PEAR system. In certain cases, an activation command for suction may be determined by characteristic of the terminal part of the inspiration signal (e.g. by I1, I3, I5), which in certain cases may be characterized by various measures relating to the sensor used for recording breath cycles, such as by such sensor's level of deceleration (or the like).

    [0128] In yet a further example, percentage of an average inspiratory duration or percentage of an average sensor displacement may be used as input for activating suction of a PEAR system. In the case when a greater than normal expiration may be anticipated, suction may be activated earlier in time or perhaps in a greater than normal magnitude, in order to evacuate a greater volume of patient's exhaled air.

    [0129] The two dashed lines linking between the lower area of the graph (indicative of a patient's breathing pattern) and the upper area of the graph (indicative of suction operation of an embodiment of a PEAR system)—illustrate an optional possibility where suction by a PEAR system may start generally at an end of an inspiratory phase (here I1) of a given breathing cycle (here cycle 1) and terminate generally at an end of an expiratory phase (here E1) of same given breathing cycle (here accordingly cycle 1).

    [0130] A normal person (with weight of about 70 kg) evacuates about 0.5 liter of air during exhalation, while the average human respiratory rate is between about 30-60 breaths per minute at birth, decreasing to 12-20 breaths per minute in adults. Taking 12 breaths per minute as the lower limit of breathing rate, renders that such a breathing cycle lasts about 5 seconds and hence the average duration of exhalation is about 2.5 or possibly 3 seconds. As a result, the lower limit of flow rate during exhalation may be about 0.15 liter per seconds (i.e. 0.5 liter divided by 3 seconds=0.1667 liter per second).

    [0131] In various embodiments, a PEAR system may be suited to remove exhaled air at a substantially higher flow rate to that expected by a typical patient, e.g. at a rate of between about 1 liter per second and a higher flow rate of e.g. about 10 liters per second (or the like) and possibly more. Such lower limit of about 1 liter per second may be substantially greater (i.e. about 5 times greater) than the corresponding lower limit of expected flow rate during exhalation (i.e. about 0.2 liter per second) that PEAR systems of at least certain embodiments of the present invention may suited to safely evacuate.

    [0132] Attention is drawn to FIGS. 8A and 8B schematically illustrating operations or various personal exhaled air removal (PEAR) system embodiments during inhalation and exhalations cycles. These graphs illustrate typical patient breathing cycles coupled with assistance provided by supportive measures, either auxiliary or integral to the PEAR systems, and the exhalation removal sequences provided by such PEAR systems.

    [0133] In at least certain embodiments, integrated type PEAR system embodiments are provided with enhanced integration between patient supportive measure and PEAR system functionalities. In certain embodiments, a supportive measure may be auxiliary to a PEAR system that it is arranged to function with, and in other embodiments, the supportive measure may be integral to a PEAR system that it is arranged to function with.

    [0134] The graph provided in FIGS. 8A and 8B illustrate inspiration and exhalation phases of a single breathing cycle, and a sensor provided in (or associated with) such PEAR system embodiments may be suited to detect and monitor these inspiration and exhalation phases.

    [0135] A supportive measure (such as a high flow nasal cannula (HFNC) type device or the like) may be arranged to continuously provide inhalation support (see indicated by numeral 77) to a patient at a substantially constant flow rate of e.g. between about 0.6 to 1 liter per second. Such inhalation support 77 is noted to preferably continue also during the expiration phase.

    [0136] Upon detection of start of an expiratory phase of the breathing cycle (or detection during an end of the previous inspiration phase that an expiratory phase is about to start)—the PEAR system may be arranged to start applying a negative suction level 99 that is greater than the flow pattern 66 of expiration by the patient. Preferably, at each instance in time along the time axis, the negative suction level 99 may be greater than the flow pattern 66 of expiration by the patient, with exceptions being e.g. during intentional formation of PEEP as seen in FIG. 8B.

    [0137] In one example, determining the flow pattern 66 of expiration by a given patient may be Obtained by monitoring the patient's expiratory flow pattern during the first one or more (N) breathing cycles during which the patient is connected to the PEAR system. In other examples, the PEAR system may be arranged to create a suction force that is greater than the maximal expected expiratory flow of a patient, while not necessarily having knowledge of the precise flow pattern that such expiratory phase of the patient may follow.

    [0138] As seen in FIG. 8B, in certain embodiments provision of a positive end expiratory pressure (PEEP) 88 may be formed by substantially lowering to below the level of the flow pattern 66, or substantially shutting off, the negative suction level 99 applied by the PEAR system towards the end of the expiration phase.

    [0139] Attention is additionally drawn to FIG. 9 illustrating a mask 44 via which airflows may be communicated back and forth between a patient and at least certain embodiments of PEAR systems. Mask 44 may be coupled in this example by a tube-like communication channel 33 to suction applied by the PEAR system (e.g. to suction applied by suction tank such as 50 seen in FIG. 7) and may include one or more unidirectional valves 22 that may allow air to flow from the outside ambient environment into the PEAR's mask, however not in the other opposing direction.

    [0140] Such valves 22 thus may permit air to flow from the outside ambient environment into the PEAR's mask during expiration (see upper left-hand side section in this figure), while sealing egress of air out of the mask during provision of inspiration to the patient via the mask by a supportive measure (see upper right-hand side section in this figure).

    [0141] Fp indicates in FIG. 9 the expiration flow of air evacuated by the patient during an exhalation phase of breathing, such as that indicated by numerals 66 in FIGS. 8A and 8B. Fe indicates in FIG. 9 the negative suction flow applied by the PEAR system to evacuate exhaled air by the patient, such as that indicated by numerals 99 in FIGS. 8A and 8B. And Fs indicates air flow entering the mask via the unidirectional valves 22 from the ambient environment.

    [0142] Fe as already discussed with e.g. respect to FIGS. 8A and 8B, may be arranged to be substantially larger than Fp in order to safely evacuate the exhaled air by the patient. In order to reduce likelihood of formation of negative pressure within the mask, the unidirectional valve(s) 22 may allow air flow to flow into the mask during operation of the PEAR system. In cases where the patient exhales less air, Fs may be urged to be larger than in cases where the patient exhales more air.

    [0143] A tube like communication channel 55 schematically illustrated in FIG. 9 may be used to channel gaseous from a supportive measure, such as that providing the continuous flow indicated by numeral 77 in FIGS. 8A and 8B, towards the patient.

    [0144] In the description and claims of the present application, each of the verbs, “comprise” “include” and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

    [0145] Further more, while the present application or technology has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and non-restrictive; the technology is thus not limited to the disclosed embodiments.

    [0146] Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed technology, from a study of the drawings, the technology, and the appended claims.

    [0147] In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures can not be used to advantage.

    [0148] The present technology is also understood to encompass the exact terms, features, numerical values or ranges etc., if in here such terms, features, numerical values or ranges etc. are referred to in connection with terms such as “about, ca., substantially generally, at least” etc. In other words, “about 3” shall also comprise “3” or “substantially perpendicular” shall also comprise “perpendicular”. Any reference signs in the claims should not be considered as limiting the scope.

    [0149] Although the present embodiments have been described to a certain degree of particularity, it should be understood that various alterations and modifications could be made without departing from the scope of the invention as hereinafter claimed.