The present technology is generally directed to ventilator systems, and in particular to ventilator systems that can deliver oxygen therapy, ventilation therapy, and/or both oxygen and ventilation therapy.
Mechanical ventilators are used to assist with breathing. For example, conventional mechanical ventilators typically drive inspiratory gases into the patient's lungs to assist with the patient's breathing. However, many patients who use a ventilator do not require constant mechanical ventilation. Instead, at various times throughout the day, they may prefer to only receive supplemental oxygen, such as pulses of oxygen received from a conventional portable oxygen concentrator. Patients who at times require mechanical ventilation and at times prefer supplemental oxygen generally have multiple different machines, including a ventilator and an oxygen concentrator, for providing these different therapies. Unfortunately, having to rely on multiple machines reduces the independence of the patient (e.g., they may not wish to leave the house without both machines) and increases the logistical burden of switching between therapy options. Accordingly, a need exists for improved systems that provide a patient with a variety of therapy options to suit their evolving needs.
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology.
The present technology is directed to ventilator systems that can provide both ventilation therapy and oxygen therapy. For example, in some embodiments the systems described herein include a ventilation assembly that can provide inspiratory gas to a patient circuit to support the patient's breathing. The patient circuit can route the inspiratory gas to the patient. The systems described herein can also include an oxygen assembly that can provide pulses of oxygen to an oxygen delivery circuit. The oxygen delivery circuit can route the pulses of oxygen to the patient. In some embodiments, the oxygen delivery circuit is distinct from the patient circuit. For example, the patient circuit can include a corrugated conduit coupled to a ventilation mask, and the oxygen delivery circuit can include a nasal cannula. The ventilation mask can be positioned over the nasal cannula so that the patient can receive both the inspiratory gases and the pulses of oxygen.
In some embodiments, the systems described herein can deliver oxygen to a patient independent of delivering ventilation therapy to a patient. For example, a patient can use the ventilator systems to solely receive pulses of supplemental oxygen through a nasal cannula, similar to patients using conventional portable oxygen concentrators. Likewise, the systems described herein can be used to deliver ventilation therapy to a patient independent of or in combination with the pulses of the oxygen. For example, a patient can receive the ventilation gases mixed with oxygen via a patient connection such as a ventilator mask or tracheal tube. As another example, a patient can receive the ventilation gases through a first patient connection (e.g., a ventilator mask), and simultaneously receive the pulses of oxygen through a second patient connection (e.g., a nasal cannula).
The systems described herein therefore provide flexible therapy options to meet evolving patient needs. For example, in some embodiments the systems described herein can (1) deliver pulses of supplemental oxygen to a patient independent of delivering ventilation therapy to the patient, (2) deliver ventilation therapy to a patient independent of delivering supplemental oxygen to the patient, and (3) simultaneously deliver ventilation gases and pulses of oxygen to the patient, either through the same or different patient connection. Providing a variety of therapy options from a single portable ventilator is expected to improve patients' quality of life by decreasing the number of breathing support devices and systems the patient must rely upon and/or by more precisely tailoring the type and level of therapy a patient needs, which may fluctuate throughout the day and/or over time.
Further aspects and advantages of the devices, methods, and uses will become apparent from the ensuing description that is given by way of example only.
The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%. The term “substantially” or grammatical variations thereof refers to at least about 50%, for example, 75%, 85%, 95%, or 98%.
The ventilator 100 can further include a breath sensing port 103. The breath sensing port 103 can include one or more transducers or sensors (e.g., sensors 208, shown in
The system 10 can further include an adapter 152 positionable between the oxygen delivery circuit 150 and the ventilator 100. The adapter 152 can interface with (e.g., plug into) both the oxygen outlet port 105 and the breath sensing port 103. As described in detail below with respect to
As described in greater detail below, the ventilator 100 can deliver oxygen to a patient independent of the ventilation therapy and/or in combination with the ventilation therapy. For example, the system 10 can operate in an oxygen mode in which it provides pulses of oxygen to the patient, a ventilation mode in which it provides inspiratory gases to the patient, and/or a combination mode in which it provides both inspiratory gases and pulses of oxygen to the patient. The ventilator 100 can operate in any of the foregoing modes when both the patient circuit 110 and the oxygen delivery circuit 150 are coupled to the ventilator 100 as shown in
The ventilator 100 can be coupled to the patient 202 via the patient circuit 110 and the patient connection 106. The patient circuit 110, which can also be referred to herein as a “ventilation gas delivery circuit,” can include a conduit or lumen (e.g., tubing) for transporting gases (e.g., the air 224 during the inspiratory phase and patient exhalation gases during an expiratory phase) to and/or from the patient 202. The patient circuit 110 can include a passive patient circuit or an active patient circuit, such as those described in U.S. Pat. Nos. 10,518,059 and 10,105,509, the disclosures of which are incorporated by reference herein in their entireties and for all purposes. The patient connection 106 can be any suitable interface coupled to the patient circuit 110 for delivering the air 224 to the patient 202, such as a full rebreather mask, a partial rebreather mask, a nasal mask, a mouthpiece, a tracheal tube, or the like.
The ventilator 100 can also include an oxygen assembly 230 for providing oxygen to the patient 202 via the oxygen outlet port 105. The oxygen can be generated internally within the ventilator, such as by a pressure-swing adsorption oxygen generator, including those described in U.S. Pat. No. 10,046,134, the disclosure of which is incorporated by reference herein in its entirety and for all purposes. When the oxygen is generated internally, the ventilator 100 may output exhaust gases (e.g., nitrogen-rich gas 236) via an outlet vent 235. In some embodiments, the oxygen may also be received from an optional low-pressure oxygen source 234 (e.g., an oxygen concentrator), and/or an optional high-pressure oxygen source 232. The ventilator 100 may therefore include a low-pressure oxygen inlet 233 configured to be coupled to the optional low-pressure oxygen source 234 and receive optional low-pressure oxygen therefrom. The ventilator 100 may also include an optional high-pressure oxygen inlet 231 configured to be coupled to the optional high-pressure oxygen source 232 and receive optional high-pressure oxygen therefrom.
The oxygen assembly 230 can be used by itself or in combination with the ventilation assembly 220 (e.g., to provide inspiratory gases mixed with oxygen). For example, the ventilator 100 can deliver pulses of oxygen to the oxygen delivery circuit 150, and the oxygen delivery circuit 150 can deliver the pulses of oxygen directly to the patient 202 (e.g., without mixing with the air 224 before being delivered to the patient). In other embodiments, a portion of the patient circuit 110 (e.g., the oxygen lumen 109 shown in
The ventilator 100 may include a control module 212 for controlling operation of the ventilator 100. For example, the control module 212 can generate one or more signals for controlling operation of the ventilation assembly 220 and/or the oxygen assembly 230. For example, the control module 212 can transition the ventilator 100 between the ventilation mode, the oxygen mode, and/or the combination mode. This may be done automatically or in response to a user input. The control module 212 can also synchronize operation of the ventilator 100 with the patient's breath. For example, in some embodiments, the control module 212 receives one or more measured parameters from the sensor(s) 208 at the breath sensing port 103. The ventilator 100 may therefore be configured to provide volume-controlled ventilation, pressure-controlled ventilation, and/or flow-controlled ventilation. For example, the control module 212 can analyze the measured parameter(s) received from the breath sensing port 103 and, based on the analysis, trigger delivery of a breath via the patient circuit 110 and/or trigger delivery of a pulse of oxygen via the oxygen delivery circuit 150. The control module 212 may also receive feedback signals from the ventilation assembly 220 and/or the oxygen assembly 230 to monitor and/or control the various aspects of the ventilator 100.
The ventilator 100 can further include a user interface 214. The user interface 214 is configured to receive input from a user (e.g., a caregiver, a clinician, or the like associated with the patient 202) and provide that input to the control module 212. The input received via the user interface 214 can include ventilator settings, parameters of operation, modes of operation, and the like. In a particular example, a user may select between the ventilation mode, the oxygen mode, and/or the combination mode using the user interface 214. The user interface 214 can further be configured to display information to the user and/or patient, including selected ventilator settings, parameters of operation, modes of operation, and the like. The user interface 214 can be any suitable user interface known in the art, such as a touch-screen having a digital display of ventilator settings and operating parameters.
The ventilator 100 can optionally include additional functions beyond the ventilation and oxygen delivery described herein. For example, the ventilator 100 can optionally include a nebulizer connection 240 for coupling to a nebulizer assembly 240 and/or a suction connection 242 for coupling to a suction assembly 243. The ventilator 100 may further include a cough-assist module (not shown) for providing cough assistance to the patient. The cough-assist module can be integrated with the ventilator 100 such that the system 10 can provide cough-assistance to the patient without disconnecting the patient from the patient circuit 110, as described in U.S. Pat. No. 9,956,371, the disclosure of which is incorporated by reference herein in its entirety and for all purposes. The ventilator 100 may further include a monitoring and alarm module 216.
The adapter 152 further includes a second arm 356 extending between the body portion 360 and a sensor connection port 357. The sensor connection port 357 can be connected to the breath sensing port 103 of the ventilator 100. For example, the second arm 356 can include a second connection feature 367 for securing the adapter 152 to the breath sensing port 103. A sensing lumen 358 can extend through the second arm 356 for providing parameters (e.g., pressure) associated with the patient's breathing to the breath sensing port 103 of the ventilator. As described in detail below, the adapter 152 prevents or at least reduces oxygen flowing from the oxygen inlet port 354 to the oxygen delivery circuit connection feature 359 from entering the sensing lumen 358, yet permits pressure signals induced by the patient's inspiratory efforts to be transmitted via the sensing lumen 358 to the breath sensing port 103 for triggering synchronized oxygen delivery.
The stopper 475 is also positioned within the body portion 360 adjacent the diaphragm 470. For example, in embodiment illustrated in
During operation (e.g., when the system 10 (
Once the pulse of oxygen is triggered, the ventilator 100 delivers oxygen to the patient via the oxygen delivery circuit 150. Because the adapter 152 is positioned between the oxygen delivery circuit 150 and the ventilator 100, the oxygen flows through the adapter 152. More specifically, the oxygen travels through the oxygen lumen 355, into the first chamber 580, and into the oxygen delivery circuit 150 at the oxygen delivery circuit connection feature 359. In some embodiments, such as described with respect to
The adapter 152 may take other forms beyond those explicitly shown herein. In some embodiments, for example, the adapter 152 may include multiple diaphragms and/or pressure transmitting membranes. The adapter 152 can also include an expandable member (e.g., a balloon) in addition to, or in lieu of, the diaphragm 470. The expandable balloon can be made of a compliant/elastic material configured to transmit at least a portion of a negative pressure induced in the oxygen delivery circuit during a patient's initial inspiratory effort to the sensor for triggering the delivery of the pulse of oxygen and/or the breath while also preventing a pressure at the sensor from exceeding a maximum threshold value during delivery of the pulse of oxygen. The expandable balloon can therefore also be described as a pressure transmitting membrane. Further yet, the adapter 152 may include a pressure relief valve to prevent the pressure at the sensor from exceeding a maximum threshold value during delivery of the pulse of oxygen.
The present technology further provides methods for delivering therapy to a patient. For example,
The method 800 can continue in step 806 by receiving, via a user interface on the ventilator, a user input corresponding to a selection of an “oxygen mode.” For example, in some embodiments the ventilator may include a touch-screen display, and a user can select “oxygen mode” from a menu of therapy options. In response to the receiving the user input in step 806, a control assembly within the ventilation can initiate oxygen mode, during which the ventilator delivers pulses of oxygen to a patient. In some embodiments, step 806 can occur before steps 802 and 804.
With the ventilator operating in oxygen mode, the method 800 continues in step 808 by measuring a pressure level via the sensing port. For example, the sensing port may measure a pressure level corresponding to a pressure within the oxygen delivery circuit that is transmitted to the sensing port via the adapter, as previously described herein. The method 800 continues in step 810 by triggering an oxygen assembly in the ventilator to provide a pulse of oxygen based at least in part on the measured pressure level. For example, the oxygen assembly can be triggered when the measured pressure level crosses a predetermined threshold, such as a threshold corresponding to a patient's initial inspiratory efforts, such that delivery of the oxygen pulse coincides with a patient's natural inspiration. In some embodiments, the predetermined threshold is 0 PSI, and the oxygen assembly is triggered when the pressure in the system transitions from positive to negative (indicating the patient has begun inspiration). In another embodiment, the predetermined threshold is a non-zero value corresponding to a baseline pressure value in the system, and the oxygen assembly is triggered when the pressure in the system falls below the baseline pressure value in the system. In another embodiment, the predetermined threshold is a rate of change of the pressure value of the system.
Once the oxygen assembly is triggered, the method 800 continues in step 812 by delivering the pulse of oxygen to the patient. This can include, for example, routing the pulse of oxygen from the ventilator, through the adapter coupled to the oxygen outlet port of the ventilator, and into the oxygen delivery circuit for delivery to the patient. As described previously, the adapter can prevent the pressure level at the sensing port from exceeding a maximum threshold value (e.g., 5 PSI, 10 PSI, etc.) during delivery of the pulse of oxygen. The method 800 can continue by iteratively repeating steps 808, 810, and 812 to provide pulses of oxygen to a patient synchronized with the patient's respiration.
The method 900 can continue in step 904 by connecting a first end portion of a patient circuit (e.g., the patient circuit 110) to an inspiratory gas outlet port (e.g., the main ventilator connection 104 of the ventilator 100). The patient circuit can be any suitable patient circuit known in the art for delivering ventilation therapy to a patient, such as an elongated corrugated conduit. The method 900 can continue in step 906 by positioning a ventilation mask coupled to a second end portion of the patient circuit over the patient's mouth and/or nose. If the patient is already receiving oxygen therapy, positioning the ventilation mask over the patient's mouth and/or nose can include positioning the ventilation mask over the oxygen delivery circuit (e.g., the nasal cannula) that is delivering the oxygen to the patient.
With the ventilator operating in combination mode, the method 900 continues in step 908 by measuring a pressure level via the sensing port. For example, the sensing port may continue to measure a pressure level corresponding to a pressure within the oxygen delivery circuit that is transmitted to the sensing port via an adapter, as described with respect to
Once the ventilation assembly and the oxygen assembly are triggered, the method 900 continues in step 912 by delivering the pulse of oxygen and the inspiratory gases to the patient. As described above with respect to the method 800, the pulse of oxygen can be routed from the ventilator, through the adapter coupled to the oxygen outlet port of the ventilator, and into the oxygen delivery circuit for delivery to the patient. The inspiratory gases can be routed from the ventilator, through the patient circuit, and into the ventilation mask for delivery to the patient. In some embodiments, the pulse of oxygen and the inspiratory gases are delivered to the patient simultaneously. In other embodiments, the pulse of oxygen is delivered first, and the inspiratory gases are delivered at or after the delivery of the pulse is terminated. However, even when the delivery of the oxygen and inspiratory gases is offset, the inspiratory gases are still delivered during the patient's natural inspiratory phase. Moreover, although described as providing inspiratory gases during a patient's natural inspiratory phase, one skilled in the art will appreciate that the method 900 can also include providing a positive pressure within the patient circuit throughout the patient's breathing cycles (e.g., during both the patient's inspiratory and expiratory phases), consistent with positive-end-expiratory-pressure (PEEP) ventilation. The method 900 can continue by iteratively repeating steps 908, 910, and 912 to provide pulses of oxygen and inspiratory gases to a patient synchronized with the patient's respiration.
As one of skill in the art will appreciate from the disclosure herein, various components of the systems described above can be omitted without deviating from the scope of the present technology. For example, in some embodiments the adapter can be omitted, and the oxygen delivery circuit (e.g., the cannula) can have a first lumen extending between the breath sensing port 103 and the patient and a second lumen extending between the oxygen outlet port 105 and the patient. The first lumen can be used to sense the patient's initiation of inspiration, and the second lumen can be used to deliver pulses of oxygen to the patient. The first and second lumens can be fluidly isolated to ensure that the breath sensing port 103 remains fluidly isolated from the oxygen outlet port 105 during application of oxygen pulses.
Likewise, additional components not explicitly described above may be added to the systems without deviating from the scope of the present technology. For example, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Moreover, although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. Accordingly, the present technology is not limited to the configurations expressly identified herein, but rather encompasses variations and alterations of the described systems and methods.
Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Further, where specific integers are mentioned herein which have known equivalents in the art to which the embodiments relate, such known equivalents are deemed to be incorporated herein as if individually set forth.
The present application claims priority to U.S. Provisional Application No. 63/128,739, filed Dec. 21, 2020, and titled “VENTILATOR SYSTEMS WITH INTEGRATED OXYGEN DELIVERY, AND ASSOCIATED DEVICES AND METHODS,” the disclosure of which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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63128739 | Dec 2020 | US |