Apparatus and method for convertible volume and pressure-controlled lung-protective ventilation

Abstract

To provide an apparatus and a method for convertible volume and pressure-controlled lung-protective ventilation.SOLUTION: There is provided a system for actuating a volume and / or pressure-controlled manual ventilator including the manual ventilator, a storage case, and an actuating mechanism. The manual ventilator includes a compressible body, an output one-way valve at an output end, and an input one-way valve at an input end. The storage case includes an inner housing surface configured to accommodate the manual ventilator. The actuating mechanism includes a power unit mechanically coupled to a linear rod mechanism and one or more applicator pads mechanically coupled to the linear rod mechanism and proximal to the compressible body. The linear rod mechanism is configured to convert a rotating motion of the power unit into an axial movement of the linear rod mechanism. The actuating mechanism is configured to apply pressure to the compressible body of the manual ventilator via the one or more applicator pads such that a volume of the compressible body is deflated.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to the field of medical devices for life saving and life support, and more specifically to a process for delivering artificial ventilation, either automatically or manually (i.e., manually operated), during medical or animal care. [Background technology]

[0002] There are several medical conditions in which a patient, either a human under the care of a medical provider or an animal under the care of a veterinarian (collectively referred to herein as the patient), is unable to maintain his or her own vital respiratory function without some degree of mechanical assistance. For example, a patient whose respiratory reflex is suppressed by pharmacological, traumatic, or physiological paralysis may have a total lack of respiratory effort and may rapidly progress to a state that will lead to death if respiratory function is not provided via external means. Other patients may have underlying trauma or pathophysiological conditions that cause a significantly elevated work of breathing, such that respiratory function declines to the point where progressive fatigue causes breathing to cease. Such conditions, in which normal respiratory function is replaced by external means, are known in the art as artificial ventilation (more colloquially, artificial "breathing" or "life support").

[0003] Artificial ventilation can generally be achieved by means of applying positive or negative pressure to the patient to inflate and deflate the lungs. Positive pressure ventilation is achieved by creating a positive pressure gradient in the lungs relative to the surrounding atmospheric pressure, thereby inflating the lungs. Alternatively, negative pressure ventilation is achieved by enclosing the patient's chest in an airtight container (with the head protruding) and then applying a vacuum to the body parts present within the chamber in such a way as to cause active expansion of the chest and lung expansion through a negative pressure gradient within the lungs relative to atmospheric pressure. Negative pressure ventilation closely replicates the natural function of breathing, which is achieved by the expansion of the chest wall by the action of the chest muscles and diaphragm, creating a vacuum inside the lungs, and then drawing air into the lungs under gentle negative pressure. However, the need to enclose the chest in a large chamber presents several problems (such as inability to get close to the patient due to size and care), which generally leads to positive pressure ventilation, which includes the methods used to provide artificial ventilation to patients. Summary of the Invention [Problem to be solved by the invention]

[0004] In accordance with the present invention, a method and apparatus is provided for "convertible ventilation", thereby allowing a single device to be used to provide both manual and / or mechanical ventilation.

[0005] It is an object of the present invention to be able to provide volume and / or pressure controlled manual ventilation in accordance with lung protection guidelines in either manual or mechanical mode, thereby addressing the current incompetence of users to safely protect the patient from accidental or inadvertent overinflation when manually initiating artificial ventilation and / or providing manual ventilation for periods when mechanical ventilation is not possible.

[0006] It is a further object of the present invention to provide a means for converting from manual volume and / or pressure controlled ventilation to mechanical volume and / or pressure controlled ventilation using a simplified mechanism that does not require volume and / or pressure control, and these safety elements are incorporated into the manual ventilator portion of the present invention, allowing for a more intuitive and rapid transition of patient care from manual to mechanical mode.

[0007] The present invention also provides a novel method for delivering volume and / or pressure controlled mechanical ventilation, resulting in a simpler mechanism compared to existing on-site mechanical ventilation devices, thereby making mechanical ventilation more economically accessible at the point of care compared to current on-site mechanical ventilation devices which are very expensive.

[0008] It is a further object of the present invention to permit use without a source of compressed gas if desired, further simplifying operation in both manual and mechanical modes. It is a further object of the present invention, in accordance with the above objects and advantages, to provide a simplified and more intuitive device as compared to conventional mechanical ventilation devices, such that the present invention may be safely used by non-professionals in the field, thereby providing a means for lung-protective manual and / or mechanical ventilation that is universally available to patients, whether they are being cared for by bystander laypersons, out-of-hospital first responders, paramedics, emergency medical technicians and paramedics, or in a hospital by care providers of various skill levels of those skilled in the art.

[0009] Another object of the present invention is to provide an easy conversion between manual and mechanical modes, so that the volume and / or pressure controlled manual ventilator is easily available when stored in the storage case, so that to initiate volume and / or pressure controlled manual ventilation, the user only needs to pull the volume and / or pressure controlled manual ventilator out of the storage case and start using it without delay. Furthermore, to quickly and intuitively convert from manual ventilation to mechanical ventilation, the operator only needs to place the volume and / or pressure controlled manual ventilator in the storage case, which will initiate the mechanical actuation of the storage case and the patient will automatically be transferred to volume and / or pressure controlled mechanical ventilation.

[0010] Finally, to address the various locations of care and global resource disparities, it is an object of the present invention to enable actuation to be powered by electrical, pneumatic, or mechanical energy storage means, including certain embodiments operable by one or more power supply methods. [Means for solving the problem]

[0011] Thus, one aspect of the present invention comprises: (1) a volume and / or pressure controlled manual ventilation device; and (2) a storage case for the volume and / or pressure controlled manual ventilation device, the storage case housing an actuation mechanism capable of acting on the volume and / or pressure controlled manual ventilation device, the actuation of which provides the functionality of the volume and / or pressure controlled manual ventilation device contained therein. In particular, the present invention provides mechanical volume and / or pressure controlled ventilation through novel and unintuitive means, whereby the volume and / or pressure control means are not inherent to the actuation device, but are instead provided by components of the volume and / or pressure controlled manual ventilation device of the present invention, thereby avoiding the complexity of the actuation mechanism of the storage case to provide volume and / or pressure controlled mechanical ventilation when the convertible ventilation device is used in mechanical mode.

[0012] Another aspect of the invention facilitates transitions between manual and mechanical ventilation modes. To initiate volume- or pressure-controlled manual ventilation, the volume and / or pressure settings on the volume and / or pressure-controlled manual ventilator can be selected while the volume and / or pressure-controlled manual ventilator is in the storage case and / or adjusted after removal from the storage case. The volume and / or pressure-controlled manual ventilator may be stored in a ready state with attachments specific to the manual mode (e.g., one-way valve, face mask, oxygen reservoir) already connected to minimize the time and steps required to initiate volume and / or pressure-controlled manual ventilation. To transition to mechanical mode, the attachments specific to the volume and / or pressure-controlled manual ventilator can be quickly removed, the volume and / or pressure-controlled manual ventilator can be returned to the storage case, and the attachments specific to the mechanical mode can be quickly connected. Once in mechanical mode, various adjustments can be made to the ventilation delivery settings. Additionally, an alarm mechanism contained within the storage case can be programmed to maintain the patient under automatic mechanical ventilation support without the direct supervision of a qualified person.

[0013] Embodiments of the present invention are inherently compact in size in both manual and mechanical modes, making them suitable for use in out-of-hospital care facilities and / or during patient transport. The outer housing of the storage case is preferentially fitted with clamps and / or receptacles so that it can be easily secured to a hospital bed, stretcher, gurney, military litter, or other aspects associated with patient care.

[0014] Other aspects and advantages of the present invention can become apparent from the following drawings and description, all of which are illustrative of the principles of the invention and are given by way of example only. The above mentioned advantages of the present invention, together with further advantages, may be better understood by reference to the following description taken in conjunction with the accompanying drawings, in which: The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention, in which: [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of a volume and / or pressure controlled manual ventilation device according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a perspective view of a storage case for the manual ventilator shown in FIG. 1 according to an embodiment of the present invention. [Diagram 3] 3 is a perspective view of the housing shown in FIG. 2 housing the manual ventilation device of FIG. 1 according to one embodiment of the present invention. [Figure 4] FIG. 4 is a perspective view of an actuation mechanism of the manual ventilation device of FIG. 1 in a pre-expiratory breath delivery state, according to one embodiment of the present invention. [Diagram 5] 5 is a perspective view of the actuation mechanism shown in FIG. 4 with the manual ventilation device of FIG. 1 in an intermediate state of partial exhaled breath delivery according to an embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of the actuation mechanism shown in FIGS. 4 and 5 with the manual ventilation device of FIG. 1 in a completed breath delivery state according to an embodiment of the present invention. [Figure 7] FIG. 7 is a perspective view of an actuation mechanism comprising a volume and / or pressure controlled manual ventilator according to one embodiment of the present invention, prior to expiratory gas delivery. [Figure 8] FIG. 8 is a perspective view of the actuation mechanism and manual ventilation device shown in FIG. 7 in an intermediate state of partial exhaled breath delivery, according to an embodiment of the present invention. [Figure 9] FIG. 9 is a perspective view of the actuation mechanism and manual ventilation device shown in FIGS. 7 and 8 at the completion of exhaled breath delivery in accordance with one embodiment of the present invention. [Figure 10] FIG. 10 is a perspective view of a storage case housing a volume and / or pressure controlled manual ventilation device during administration to a patient, according to one embodiment of the present invention. [Figure 11] FIG. 11 is a flow diagram of steps of a method for operating a volume and / or pressure controlled manual ventilation device according to one embodiment of the present invention. [Figure 12]FIG. 12 is a flow diagram of steps of a method for operating a volume and / or pressure controlled manual ventilation device according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] All the different positive pressure ventilation aids common to the art are generally classified as either mechanical or manual. Mechanical ventilators are medical devices capable of providing autonomous artificial ventilation to a patient. They are generally powered by electrical means, although other mechanical ventilators, especially those intended for use outside of a hospital, can be powered by a compressed gas source that allows the device to be operated by a pneumatic movement device. In contrast, manual ventilators are human-powered, that is, they are operated manually by a human operator and only function when they generate the positive pressure required to deliver exhaled air to the patient.

[0017] Several variations of manual ventilators exist in the art, ranging from simple pocket face masks that allow the operator to manually deliver exhaled breaths using their own breath, to more elaborate, but still simple, patient-connected devices that allow air to move into the patient when the operator manually squeezes an exhaled gas reservoir. Similarly, mechanical ventilators also have a wide variety of variations, but in any case are necessarily more complex than manual ventilators, since the output must be adjusted so that it can be tailored to provide a tailored or precise exhalation according to the anatomical and physiological requirements of each patient. Such adjustments include oxygen concentration, exhaled breath size (typically expressed in milliliters), inspiration time (the time during which a breath is taken), and tidal volume (the total number of exhaled breaths delivered in one minute). More sophisticated ventilators include airway pressure limits, the ability to "inspire" when the lungs are fully inflated (highly diagnostic as a tool to measure the lungs' inherent resistance to expansion, called compliance), as well as other sensor-based features that allow the mechanical ventilator to work in coordination with the patient's own respiratory efforts, particularly to help the patient eventually regain unassisted breathing function (known in the art as "weaning").

[0018] Regarding the setting of expiratory breath size (or tidal volume) by mechanical ventilation, there are two main methods commonly found in practice. In volume-controlled mechanical ventilation, a specific expiratory breath size is specified by volume (typically expressed in milliliters), whereby the device delivers a set volume independent of the airway pressure required to overcome both airway resistance and lung compliance. In contrast, in pressure-controlled ventilation, a specific maximum airway pressure is set (typically expressed in centimeters of water pressure), which continues to expand the lungs to an unspecified expiratory volume until the maximum pressure setting is equal to the intrinsic resistance of the lungs and thoracic cavity. Pressure-controlled ventilation is most often used for neonatal and pediatric patients (and small animals), while volume-controlled ventilation is typically used for larger patients.

[0019] In contrast to mechanical ventilators, manual ventilators typically lack the ability to provide specific artificial ventilation parameters; instead, the operator attempts to use good subjective judgment in manually delivering ventilation to provide the appropriate expiratory size, rate, inspiratory time, and other variables that are typically set specifically for mechanical ventilators. Thus, manual ventilators currently in use in the field are "uncontrolled" devices.

[0020] There are several embodiments of manual ventilators, with the bag-type ventilator being the most well-known. These devices include a manually compressible bag with two or more one-way valves that, when compressed, creates a flow towards the patient and expels the patient's exhaled air to the atmosphere during exhalation. There are essentially two types of manual bag ventilators. Flow-inflatable bag ventilators include a bag material that does not have an inherent inflation / deflation mode, and a constant external source of pressurized gas is required to inflate the bag before it can be manually compressed to deliver exhaled air. Flow-inflatable bags are used almost exclusively in anesthesia applications where there is always a constant source of pressurized gas, but the composition of the exhaled gas must be highly specific and contain the required concentration of anesthesia components. As a result, flow-inflatable bags appear to be mainly attached to anesthesia delivery unit machines. Furthermore, standalone flow-inflatable bags, specialized for the extremely delicate nature of premature infants, are often found in delivery rooms and, when preferred by highly specialized users, in other hospital critical care facilities. In particular, flow-inflating bags cannot function without a compressed gas source and are rarely suitable for emergency, patient transport, and out-of-hospital situations. In contrast, the second type, the self-inflating manual ventilation bag, is found in almost all out-of-hospital facilities, but within hospitals, the self-inflating bag predominates outside neonatal and anesthesia care facilities. Unlike flow-inflating bags, the material used for the self-inflating bag has elasticity and / or memory capabilities, such that after compression applied to the bag delivers a manually squeezed breath, the bag material properties are restored upon removal of the compressive force, thereby providing a self-inflating function that allows the bag to return to its normal inflated position in preparation for the delivery of the next breath. Thus, self-inflating manual bag ventilators can be used without the need for an external gas source, but typically have a connection for supplemental oxygen so that a higher concentration of oxygen can be used to deliver the breath if necessary.

[0021] The field has identified several important attributes of manual versus mechanical ventilators. Manual ventilators are simple devices that are inexpensive, typically disposable after one patient use, small and lightweight, and do not require electrical or pneumatic power to operate. For these reasons, manual ventilators are almost always the first choice for artificial ventilation because their low cost allows them to be inexpensively placed in numerous locations throughout the hospital and in life support kits outside the hospital so that they are readily available without delay in the event of an emergency. As a result, manual ventilators are available in every emergency room, every emergency "crash" center, and every emergency room. Manual ventilators are visible and ready in hospitals, all intensive care units (ICUs), and wherever mechanical ventilation (as a backup) is used. Outside of hospitals, manual ventilators are found in nearly all first response vehicles, ambulances, and outpatient clinics (especially where sedatives are used). Similar stages and use of manual ventilators are common in military, disaster response, and other emergency applications. Due to the inherent simplicity of manual bag ventilators, a wide range of personnel are easily trained in their use, from entry-level medical technicians to paramedics, emergency medical technicians, paramedics, nurses, and physicians. Finally, manual ventilators that require human operation, due to their inherent nature, are typically used temporarily until a patient who requires continuous ventilation is placed on a mechanical ventilator. However, sometimes manual ventilation can last up to an hour, and even days in developing countries. For example, most ambulance services cannot afford mechanical ventilators, especially those provided in rural areas. Artificial ventilation in such situations must continue for a period that typically corresponds to the duration of care in the field and transport to a hospital. Furthermore, global socio-economic disparities mean that current mechanical ventilation equipment lacks the financial resources and infrastructure required for it, resulting in longer periods of manual ventilation.

[0022] In contrast to manual ventilators, mechanical ventilators require power and / or compressed gas sources to operate, limiting their portability. Furthermore, when patients require artificial ventilation for days or weeks, a greater degree of precision and settings are often required, as previously mentioned, to deliver exhaled breaths that are highly tailored to the individual patient's specific anatomical lung characteristics and underlying pathology. With greater precision comes greater complexity, resulting in physically larger units (some of which are freestanding bedside units) and preparation steps that must be performed before the unit is ready to be connected to a patient. With the increased size and complexity comes a significant increase in cost, resulting in mechanical ventilators generally being too expensive to deploy in every patient room in case a patient needs them in an emergency.

[0023] In addition to the complexities and costs surrounding the mechanical ventilation equipment itself, there are secondary costs associated with the need for specialized personnel specifically trained in its use. Typically, only ICU physicians (e.g., intensivists and pulmonologists) are adequately trained in prescribing long-term ventilation settings, with respiratory therapists constituting an entirely separate career field in medical technology, in part, providing the specialized aptitude required to set up, configure, and maintain mechanical ventilation equipment.

[0024] All of the above factors limit the suitability of mechanical ventilators as a first-choice device for providing artificial ventilation, since patients who are unable to breathe on their own cannot remain without ventilatory support for the time it takes for the machine to be transported to the patient and set up by specialized personnel. These reasons have created barriers to the widespread adoption of mechanical ventilators for use outside of hospitals.

[0025] Therefore, artificial ventilation is almost always performed according to two stages of care: Artificial ventilation is initiated by a manual ventilator, even during routine induction of anesthesia during surgery. In emergency situations, whether in hospital or outside medical facilities, the manual ventilator is the first available artificial ventilation device. In situations where mechanical ventilation is not available outside or inside the hospital, after manual ventilation has been started, it is continued until it is no longer necessary (due to recovery or death of the patient) or until the patient can be transferred to a mechanical ventilator (meaning that outside surgery, mechanical ventilators are usually not readily available).

[0026] Even once a patient is able to transition from manual ventilation to mechanical ventilation, there are times when a return to manual ventilation is required. As mentioned above, mechanical ventilation devices are often not portable, so the need to transport patients within the hospital often requires periods of manual ventilation during the transfer. For example, patients who are mechanically ventilated during surgery and then need to remain ventilated during recovery in the ICU are often removed from the advanced mechanical ventilation provided by the anesthesia induction unit, manually ventilated during transfer to the ICU, and then returned to the mechanical ventilation device in the ICU with settings that are highly specific to each particular patient. Patients who are mechanically ventilated in the ICU may sometimes have to be returned to manual ventilation while being transferred to other areas of the hospital for diagnostic examinations with computed tomography (CT) and / or magnetic resonance imaging (MRI) and / or while being transferred to specialized care units where certain interventional procedures are performed that are not suitable for the ICU environment. Finally, manual ventilation is typically used as a backup immediately when the mechanical ventilator requires maintenance, is suspected to be malfunctioning, or has failed (e.g., upon power loss or when the compressed gas source is exhausted and the pneumatically driven mechanical ventilator ceases to function). As a result, patients undergoing long-term mechanical ventilation are inevitably exposed to manual ventilation lasting from a few minutes up to an hour (or even longer if a mechanical ventilator is not immediately available, as mentioned above).

[0027] Due to the inherent differences in precision between manual and mechanical ventilation, there is a large patient safety gap between the two modes. While mechanical ventilators can deliver precise and coordinated exhalations, manual ventilators have no built-in exhalation management settings and are essentially uncontrolled devices. There is robust peer-reviewed research demonstrating that healthcare providers attempting to use appropriate subjective judgment with manual bag ventilation, regardless of training, routinely fail this task. Studies of healthcare provider ability to deliver exhaled volumes within the range of a patient's natural vital capacity have shown that even physicians erroneously overinflate beyond natural vital capacity more than 72% of the time. (Bassani MA, FilhoFM, de Carvalho Coppo MR, MarbaSTM. "Assessment of peak inspiratory pressure, tidal volume, and ventilation rate during ventilation with a neonatal self-inflating bag resuscitator." RespiratoryCare 2012;57:525-530). Observational human clinical studies have evaluated physician use of manual bag ventilation in human cardiac arrest patients and have shown that highly variable expiratory volume may be delivered in excess of natural vital capacity by more than two-fold (O'Neill JF, Deakin CD "Are we overventilating cardiac arrest patients?" Resuscitation 2007;73,82-85). Unable to control lung inflation This is now known to be the direct cause of acute lung injury (ALI), now more specifically called ventilatory induced lung injury (VILI), where overinflation from hyperextension causes direct tearing of delicate lung tissue. The injury pattern of VILI causes inflammation of the lungs that reduces their ability to oxygenate the blood. In cases where hyperextension is mild, lung damage may require supplemental oxygen and hospitalization until the lungs heal. However, in cases of moderate lung injury, individual and / or prolonged mechanical ventilation with high concentrations of oxygenation required to sustain life is often required.

[0028] Further peer-reviewed studies have demonstrated that the severity of VILI / ALI can be mitigated altogether or avoided altogether if patients are protected from hyperinflation. A 2000 research collaboration confirmed that not hyperinflating the lungs of ICU patients already undergoing ALI promoted healing and improved mortality by approximately 28%. This study was supported by the Acute Respiratory Distress Syndrome Network: Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. "Analysis of acute lung injury and acute respiratory distress syndrome." The current definitive guideline for providing lower tidal volume ventilation compared to conventional tidal volumes for pulmonary circulation (N Engl J Med. 2000 May4;342(18):1301-1308.) More recent studies have shown that adherence to lung protection guidelines in patients without lung injury actually prevents the occurrence of VILI in approximately 61.8% and 62.0% of cases (respectively) (Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S, "Improvement Research 2013 Aug 1;369(5):428-37;and Fuller BM, Ferguson IT, Mohr NM, Drewry AM,Palmer C, Wessman BT, AblordeppeyE, Keeperman J, Stephens RJ, Briscoe CC, Kolomiets AA, Hotchkiss RS, KollefMH. Emergency department initiated lung protective ventilation (LOV-ED): before and after a quasi-experimental trial. Ann Emerg Med. 2017 Sep;70(3):406-418, also published in BMJ. 2016 Apr 11;6(4). The latter study evaluated the impact of adopting lung-protective ventilation in emergency room patients and those immediately following initiation of mechanical ventilation and found that protecting patients from accidental hyperinflation in the early phases of care led to a sharp reduction in severe hospital-acquired VILI and improved patient survival by 42.5%.

[0029] This peer-reviewed evidence demonstrates both (1) that failure to adhere to lung protection guidelines, even for a relatively short period of time, can be fatal by directly causing VILI, and (2) that, regardless of training, healthcare providers will end up overinflating and fail to achieve guideline compliance when using a manual bag ventilator, clearly demonstrating the need for a manual bag ventilator that can adhere to lung protection guidelines. The need for such a device has been anticipated by Maguire (U.S. Pat. Nos. 7,121,278 and 7,392,805 teach devices and methods for dual-control manual ventilators), who provide methods and devices for performing volume- and / or pressure-controlled manual ventilation. As a result, this device can address the significant disparity in patient safety between mechanical and manual ventilation, since it can adhere to lung protection guidelines, i.e., uncontrolled delivery of exhaled air does not result in overinflation leading to VILI. Such an approach provides a methodology for providing universal guideline compliant ventilation throughout the period of conversion between manual and mechanical modes.

[0030] As mentioned above, artificial ventilation is initiated using a manual ventilator, after which a separate mechanical ventilator is required to transition the patient to the automatic mode best suited for sustained support. The need for two separate (manual and mechanical) devices poses cost and logistical challenges. As mentioned above, the financial resources currently required for on-site mechanical ventilators are not available in many emergency services and hospitals in developing countries. Moreover, even in hospitals with advanced health systems, the costs have proven too high to make mechanical ventilators readily available in most patient rooms. Furthermore, transport ventilators specifically designed for use in ambulances and for moving patients around the hospital are considered too expensive for widespread deployment.

[0031] Thus, we see that although it is common for ventilated patients to alternate between manual and mechanical ventilation, substantially different and separate methods are used for this purpose. We also see that, often, in care facilities, patients must be ventilated for an hour or more, or even for days, when the financial resources required to provide mechanical ventilation are not available. We also see that manual ventilation must always be on hand during mechanical ventilation if it is required to sustain life, if the mechanical ventilation requires maintenance, is suspected of failure, or fails. We also see that small size is one of several practical requirements for mechanical ventilation to be suitable for use outside of hospitals and for portability. Finally, significant cost, logistical, and practical barriers prevent widespread use of mechanical ventilation, especially in developing countries. We see, therefore, a dire need for a single, cheaper, easily transportable, convertible device capable of delivering lung-protective ventilation in both manual and mechanical modes.

[0032] In accordance with the above description, FIG. 1 shows a preferred embodiment of a volume and / or pressure controlled manual ventilator having an inlet end, an output end, and a control configurable to allow a user to adjust the output volume and / or maximum pressure. This preferred embodiment is shown with an exhalation valve and a patient face mask suitable for use in manual mode. Although the preferred embodiment is cylindrical, it should be understood that other configurations of the volume and / or pressure controlled manual ventilator are possible, such as a rectangular ventilator, while still falling within the scope of the present invention. The preferred cylindrical embodiment of the volume and / or pressure controlled manual ventilator of FIG. 1 is configured to compress along the minor axis of its shape. It should be understood that other configurations of compression, such as along the major axis of the volume and / or pressure controlled manual ventilator, are other possible configurations within the scope of the present invention.

[0033] 2 shows a preferred embodiment of a housing for a volume and / or pressure controlled manual ventilator, the housing having an inner housing surface of sufficient shape and size to house the volume or pressure controlled manual ventilator, together with an outer housing surface that is preferably compact and shaped so that it can be placed in close proximity to a patient without being unduly invasive to other medical devices.

[0034] Figure 3 shows a preferred embodiment of the volume and / or pressure controlled manual ventilator of Figure 1, which is placed inside the preferred embodiment of the inner housing surface of the storage case of Figure 2, but is adapted to have the exhalation valve and patient face mask removed from the volume and / or pressure controlled manual ventilator prior to installation in the unit. The inner housing surface allows for easy insertion and removal of the volume and / or pressure controlled manual ventilator, thereby providing a means according to the invention for quickly switching between manual mode (where the volume and / or pressure controlled manual ventilator is manually operated by the user) and mechanical mode (where the volume and / or pressure controlled manual ventilator is mechanically actuated via an actuation mechanism contained within the storage case).

[0035] Figure 4 shows a preferred embodiment of the volume and / or pressure controlled manual ventilation device of Figure 1, which is placed inside a preferred embodiment of the inner housing surface of the storage case of Figure 2, although the actual housing surface is not shown in order to better illustrate a preferred embodiment of the actuation mechanism contained within said storage housing. The actuation mechanism is depicted in an operational state prior to expiratory breath delivery from both long and short axis views (with the long axis view shown above the short axis view in the figures).

[0036] Figure 5 shows the same components of Figure 4 in both long and short axis views, but with the actuation mechanism depicted in a configuration that represents the intermediate steps of partial exhalation delivery from the convertible ventilator to the patient. This configuration also represents the intermediate steps of partial re-inflation of the ventilator that occurs while the patient is actively exhaling after the previous exhalation has been delivered from the convertible ventilator. Figure 6 shows the same components of Figure 4 in long and short axis views, except that the actuation mechanism is shown in a configuration where exhalation delivery has been completed. Figures 7-9 show another embodiment of the invention in the same views and in similar configurations as shown in Figures 4-6, respectively.

[0037] With respect to the reference numbers in Figures 1-9, the 10's indicate various configurations and components of the volume and / or pressure controlled manual ventilator, the 20's indicate various attributes of the storage case housing, and the 30's indicate various actuation means (mechanical, electrical and / or pneumatic) within the housing that interface with the volume and / or pressure controlled manual ventilator to activate the volume and / or pressure controlled manual ventilator.

[0038] The 40 series numbers indicate various components that may be used to convey the associated motion from one or more power sources to the 30 series operating components. The 60 series numbers indicate various connection means to the patient suitable for use in manual, mechanical, or both modes of operation.

[0039] Finally, the 90 series numbers indicate external connections to electrical and / or pneumatic means of the case, including, but not limited to, one or more connections to a source of compressed air and / or oxygen, and / or one or more connections to a power source.

[0040] 1, a preferred embodiment of a volume and / or pressure controlled manual ventilator 10 is shown. The manual ventilator 10 includes an output end 61, an output one-way valve assembly 62, and an input end having a one-way valve 63. When the volume and / or pressure controlled manual ventilator 10 is manually compressed by a user, the one-way valve at the input end 63 is forced closed and gas contained within the volume and / or pressure controlled manual ventilator 10 is directed to the output end 61. In the illustrated configuration, the output of gas is further directed through the output one-way valve assembly 62 to an output connector 65 which is connectable to a patient interface means such as a face mask 66 or alternatively an airway tube (not shown).

[0041] After delivery of the exhaled breath, releasing compression on the volume and / or pressure controlled manual ventilator 10 closes the output one-way valve 62, thereby inhibiting breath from the patient from entering the volume and / or pressure controlled manual ventilator 10. At the same time, if the volume and / or pressure controlled manual ventilator 10 is self-inflating, the elasticity and / or memory function of the unit re-inflates to create a vacuum that opens the input one-way valve 63, which becomes the gas source facilitating re-inflation of the volume and / or pressure controlled manual ventilator 10. Alternatively, if the volume and / or pressure controlled manual ventilator is flow inflating, a flow source connected to the input one-way valve 63 forces the valve 63 open, thereby facilitating re-inflation of the volume and / or pressure controlled manual ventilator 10 under the operating pressure of the flow source.

[0042] When used in manual mode, the volume and / or pressure controlled manual ventilator 10 may be fitted with a pressure relief valve 64 to maintain a minimum positive pressure on output 66 to the patient, which constitutes a means for achieving positive end expiratory pressure (PEEP).

[0043] In a preferred embodiment of the present invention, the output one-way valve assembly 62, the pressure relief valve 64, the output connector 65, and the patient interface 66 are easily and quickly removable as a single assembly, thereby preparing the volume and / or pressure controlled manual ventilator 10 for placement in a storage case (not shown in FIG. 1) as a preparatory step prior to conversion from manual mode to mechanical mode.

[0044] 2 shows a housing 20 having an exterior housing surface 21 and an interior housing surface 22. The exterior housing surface 21 is preferably designed to minimize exterior dimensions for maximum portability and may have one or more external connections in any configuration (illustration of any particular configuration in FIG. 2) to allow connection to one or more compressed air and / or oxygen sources, one or more electrical connections (such as internal and / or external battery packs and / or wired power sources), one or more wired and / or fiber optic or other optical connections for information exchange, and / or connection to a control means.

[0045] 2 also illustrates how the interior surface 22 of the housing may be designed to accommodate a volume and / or pressure controlled manual ventilation device. Additionally, the interior surface 22 may provide one or more fastening points for an actuation mechanism component, including one or more grooves specifically configured to direct the movement of one or more associated components of the actuation mechanism.

[0046] Figure 3 shows a preferred embodiment of the volume and / or pressure controlled manual ventilation device 10 of Figure 1 disposed within an inner surface 22 of a housing 20. It can be seen that the outer surface 21 of the housing 20 is not substantially larger than the preferred embodiment of the volume and / or pressure controlled manual ventilation device 10, thereby forming a compact device.

[0047] FIG. 4 shows a preferred embodiment of a volume and / or pressure controlled manual ventilator 10, as well as components of a preferred aspect of the actuation mechanism for the invention to operate in mechanical mode. The top view of FIG. 4 shows a long axis view, and the bottom view of FIG. 4 shows the same components and configurations as the top view (to the extent they are visible). It should be noted that due to the symmetry of the invention, reference numbers referring to components on one side of each view also refer to visually identical components on the opposite side. The actuation mechanism is primarily driven by a power unit 30, which may include an electric servo-type motor or equivalent accessories operable from pneumatic and / or hydraulic means. The power unit 30 preferably comprises a dual channel pulley 39 capable of transmitting rotational force to one or more belts or chains 31. The belt or chain 31 may be directly connected to the receiving pulley 33, which in turn is connected to a linear rod mechanism 35, 36, which includes an outer housing 35 and an inner rod 36, which converts the rotational motion of the power unit 30 into back and forth or axial motion of the linear rod mechanism. Alternatively, the belt or chain 31 may be indirectly connected to the receiving pulley 33 by one or more transmission pulleys 32 to allow flexibility in the relative positioning of the power unit 30 with respect to the linear rod mechanism. The relative sizes of the power unit pulley 39, the receiving pulley 33, and the one or more transmission pulleys 32 (if any) may be chosen to optimize the torque, precision, and rotational speed of the actuation mechanism to best suit the application of a volume and / or pressure controlled mechanical ventilation system.

[0048] In a preferred variation shown in FIG. 5, once the rotational motion is transferred to the receiving pulley 33, it is transferred directly to the outer housing 35 of the linear rod mechanism, causing the outer housing 35 to rotate. The outer housing 35 of the linear rod mechanism is maintained in a fixed physical position without any impediment to the rotational motion transferred by the receiving pulley 33, which in this preferred embodiment is provided by one or more bearings 34. The outer housing 35 of the linear rod mechanism is preferably engaged with a thread pattern that matches the opposing thread pattern of the inner rod 36. While the linear rod 36 does not move in rotation, the outer housing 35 of the linear rod mechanism rotates, which rotation essentially moves the linear rod 36 back and forth relative to the outer housing 35 of the linear rod mechanism. The thread pitch patterns of the outer housing 35 of the linear rod mechanism and the linear rod 36 can be configured to optimize the torque, precision and rotational speed of the actuation mechanism to best suit the application of volume and / or pressure controlled mechanical ventilation.

[0049] The inner rod 36 of the linear rod mechanism is connected to an applicator pad 42, which is positioned to apply pressure directly to the outside of the volume and / or pressure controlled manual ventilation device 10 such that the linear rod mechanisms 35, 36 effectively control the inflation and deflation of the volume and / or pressure controlled manual ventilation device 10. This can be accomplished directly by configuring the linear rod mechanisms 35, 36 parallel to the movement of the applicator pad 42 required to compress the volume and / or pressure controlled manual ventilation device 10. However, to provide a more compact overall configuration of the preferred embodiment, the linear rod mechanisms 35, 36 are configured perpendicular to the movement of the applicator pad 42 required to compress the volume and / or pressure controlled manual ventilation device 10. As a result, the linear rod 36 is connected to the transmission rod 41 with one or more hinges 40 that restrict movement of the linear rod 36 with the transmission rod 41 to movement in a single plane such that the applicator pad 42 can move in a manner that causes compression of the volume and / or pressure controlled manual ventilation device 10, and such that sufficient redirection of the actuation motion is possible. The length and other attributes of the transmission rod 41 relative to the movement of the inner rod 36 and the applicator pad 42 can be provided to optimize the torque, precision and rotational speed of the actuation mechanism to best suit the application of volume and / or pressure controlled mechanical ventilation.

[0050] Thus, the configuration of components shown in FIG. 4 depicts a volume and / or pressure controlled manual ventilator 10 fully inflated and primed to deliver exhaled gases to a patient. 5 includes the same components as FIG. 4, but differs from the configuration of FIG. 4 in that the belt or chain 31 transmits a rotational force to the receiving pulley 33 by the operation of the power unit 30, and as a result, the applicator pad 42 compresses the volume and / or pressure controlled manual ventilation device 10 by the extension of the inner rod 36. No. 7,392,805 and U.S. Pat. No. 7,392,805. From the embodiment, it can be seen how the volume control achievable through the primary mechanism inherent in the volume and / or pressure controlled manual ventilation device 10 is provided. And the device configuration of FIG. 5 (and FIG. 8) may represent the state where the volume and / or pressure controlled manual ventilation device 10 has completed the delivery of the exhaled breath when the exhaled breath size is set smaller than the maximum exhaled breath size deliverable by the volume and / or pressure controlled manual ventilation device. Also, the device configuration of FIG. 5 represents partial re-inflation with the reversed actuation mechanism provided by reversing the direction of the motor unit 30. Reverse action can also be provided by various intuitive embodiments such as a reverse gear clutch mechanism or other means.

[0051] Figure 6 includes the same components as Figures 4 and 5, but differs from the configuration of Figures 4 and 5 in that further actuation of the power unit 30 causes the actuation mechanism to completely collapse the volume and / or pressure controlled manual ventilator 10. This configuration illustrates the maximum possible expiratory volume being delivered by the volume and / or pressure controlled manual ventilator when configured to allow delivery of that maximum expiratory size.

[0052] Several control elements are provided for user control of the rotational movement of the motor unit 30. Such control may be, but is not limited to, user-settable direction and / or rotational speed, etc. Such control may be via logic circuits, microprocessors, and / or other control means common in the art of controlling rotational movements.

[0053] Another control element of the invention may be the actuation of an external exhalation valve included in the exhalation circuit that connects the mechanical ventilation device to the patient. These are typical in the field and allow the gas from the patient's exhalation to be diverted into a tubing circuit other than the one used to deliver the inhalation gas. Such an exhalation valve may be operated by pneumatic or electrical action.

[0054] Additionally, several sensor elements common in the art of linear motion, pressure sensing, and / or electrical impedance may be used to provide feedback to a user, logic circuitry, a microprocessor connected to motor unit 30, and / or other elements of the present invention. For example, pressure sensors may be attached to output 61, either side of output one-way valve assembly 62, either side of input one-way valve assembly 63, and / or other portions of the present invention such that pressure measurements at various locations throughout the present invention may be used as feedback to a user or as input data available to the logic circuitry, microprocessor, other sensors, and / or control means.

[0055] Some sensor elements specific to an electrically operated motor functioning as power unit 30 are common to electric motor feedback and control technology. Sensors providing real-time data regarding the rotational position of the motor allow for differential calculation of rotational speed by calculating the change in rotational position over a particular unit of time. Rotational acceleration can be calculated by continuous calculation of rotational speed over time. Examples of sensors known in the art include resolvers, encoders, and / or sensors acting on Hall effect means.

[0056] The described embodiments should be understood as merely examples, and the present invention is not limited to the described aspects, but includes all substantially equivalent aspects. For example, Figures 7-9 show an alternative embodiment of a volume and / or pressure controlled manual ventilation device 10 in the same configuration and view as shown in Figures 4-6, respectively, which has a plurality of opposing compression surfaces 11 and a rigid collapsible gas chamber 12. The gas chamber 12 has one or more folds 13 to facilitate folding of the gas chamber 12 when compressed manually and / or by an applicator pad 42. Other embodiments of the volume and / or pressure controlled manual ventilation device 10 that can be used manually or mechanically can be intuitively derived from the present invention.

[0057] Also, alternative embodiments and / or arrangements of the power units 30 shown in Figures 4 to 9 can be intuitively derived from the present invention. For example, instead of the transmission pulleys 32 and belt or chain 31 as means for ensuring synchronous movement of the transmission rod 41 and the applicator pad 42, the two power units 30 may be directly connected to the receiving pulley 33 and controlled by a logic circuit or other control means that provides synchronous movement.

[0058] Alternative embodiments of the linear rod mechanisms 35, 36 shown in Figures 4 to 9 can also be derived intuitively from the present invention. Hydraulic and / or electromagnetic actuators may be used instead of the linear rod mechanisms 35, 36, whereby the synchronous movement of the hydraulic and / or electromagnetic actuators may be realized via a logic circuit or other control means that directly acts on the transmission rod 41 and the applicator pad 42 to provide the synchronous movement. In this embodiment, the transmission pulley 32 and the belt or chain 31 may be omitted.

[0059] Another alternative embodiment of the linear rod mechanisms 35, 36 can be intuitively derived from the present invention, in which the transmission rod 41 can be omitted by mounting the linear rod mechanisms 35, 36 in line with the intended movement of the applicator pad 42. This can be achieved by an intuitive reconfiguration of the transmission pulley 32 and belt or chain 31 relative to the power unit 30, or by one of several alternative embodiments providing logic or other control means for synchronizing the movement of the linear rod mechanisms 35, 36 and the applicator pad 42.

[0060] Finally, another alternative embodiment for converting the rotary motion of the power unit 30 into a back and forth motion of the linear rod mechanisms 35, 36 can be intuitively derived from the present invention by using one or more shafts that may be fitted with a series of one or more sprockets, and / or universal joints, and / or other means that allow the connected shafts to assume a suitable configuration for transmitting the rotary motion of the power unit 30 to the linear rod mechanisms 35, 36.

[0061] FIG. 10 shows examples of various specific external connections for a preferred embodiment of the housing 20 housing the volume and / or pressure controlled manual ventilator 10. An external compressed oxygen connection 95 and an external compressed air connection 96 are provided to allow the invention to draw in exhaled gases for subsequent administration to the patient. Alternatively or additionally, separate connections can be provided for the use of anaesthetic gases. Ventilation circuit 93, 94 connections are also provided, typical of techniques providing mechanical ventilation. A ventilation circuit inhalation connection 97 allows the invention to deliver inhaled gases to the patient via the ventilation circuit. A ventilation circuit exhalation connection 98 allows the invention to receive exhaled gases from the patient. An external exhalation valve control tube / wire 99 allows the invention to actively close an exhalation valve 92 located near the connection to the patient, thereby inhibiting inhaled gases from bypassing the patient when exhalation is being delivered. This external exhalation valve could also be located directly adjacent to the ventilation circuit exhalation connection 98, thereby shortening the exhalation valve controlling tube / wire 99.

[0062] With the attributes of the device now adequately described, various methods of providing mechanical ventilation will now be described with reference to the figures mentioned above. Of the characteristics of artificial ventilation, the most important is the tidal volume, i.e. the amount of inspired gas delivered to each patient with each expiration. The essence of the present invention is the control of the tidal volume via the volume and / or pressure controlled manual ventilator 10. If the user directly compresses during manual mode, the volume and / or pressure controlled manual ventilator will stop allowing further delivery of additional inspiratory volume once a set maximum is reached. The user can then manually release the compression and re-inflate the unit in preparation for the delivery of the next expiration. To provide this same functionality during mechanical mode, whereby the volume and / or pressure controlled manual ventilator 10 is compressed by the action of the motor unit 30 (or other alternatives as previously mentioned), a logic circuit, microprocessor or other control means can be programmed to set a maximum power output using sensors and control means as a feedback loop. This maximum power output setting is greater than the resistance required to generate enough force to inflate the patient's lungs under positive pressure, but less than a power setting sufficient to cause the collapse of the volume and / or pressure controlled manual ventilator 10. This may then be coupled to a sensor means that enables the logic circuitry and / or microprocessor to detect when the pre-set tidal volume selected on the volume and / or pressure controlled manual ventilator 10 has been fully delivered, causing the logic circuitry and / or microprocessor to activate the motor unit 30 in the reverse direction to allow re-expansion of the volume and / or pressure controlled manual ventilator 10 in preparation for the delivery of the next exhaled breath.

[0063] Whenever mechanically delivered exhaled air is delivered, compression of the volume and / or pressure controlled manual ventilator 10 by the applicator pad 42 causes an increase in pressure within the volume and / or pressure controlled manual ventilator 10, closing the input one-way valve assembly 63, thereby propelling the exhaled gas towards the output end 61. Note that the exhaled gas then travels through the output one-way valve assembly 62 and into the ventilation circuit 94 through the ventilation circuit inlet connection 97. To prevent exhaled gas intended for the patient from bypassing the patient and directly entering the exhalation tube of the circuit and looping back to the ventilator, a control means actively closes the external exhalation valve 92 via the external exhalation valve control tube / wire 99. Various control means can be provided during active compression of the volume and / or pressure controlled manual ventilator 10, as provided by the motor unit 30 or other alternative embodiments described above. The rotational speed of the motor unit 30 can be programmed to rapidly accelerate from zero rotational motion to the rotational speed required to actively compress the volume and / or pressure controlled manual ventilator 10 over a preferred time period (e.g., 1 second). Alternatively, the rotational speed of the motor unit 30 can be programmed to gradually accelerate from zero rotational motion to the rotational speed required to actively compress the volume and / or pressure controlled manual ventilator 10 over a longer time period (e.g., 2 seconds). This shows a direct relationship between the rotational speed of the motor unit 30 and the compression of the volume and / or pressure controlled manual ventilator 10, thereby generating a forward gas flow to the patient under controllable means. The flow towards the patient can be increased by making the motor unit 30 rotate at a higher speed, which helps to deliver a given volume of exhaled air over a shorter period of time for the same volume of exhaled air delivered under a slower rotational speed of the motor unit 30.

[0064] As described, the patient's ability to time the duration of inhalation is effectively controlled by controlling both the time for inhalation (or "I time") and the pause between inhalations when taking a breath (or "E time"). The pause time is controlled by controlling the interval between delivered exhalations. This also allows reliable control of the number of exhalations per minute during mechanical ventilation. For example, one complete cycle of inhalation and exhalation with an I time of 2 seconds and a pause between each inspiration (E time) of 4 seconds is 6 seconds long, which corresponds to 10 cycles of breaths delivered per minute. It is also common in the field to often refer to the ratio of I time to E time. In this example, I:E is 2:4, which is 1:2 when expressed as a ratio. Thus, the present invention can easily accommodate control settings including inspiratory flow rate, I:E ratio, I time, and ventilation rate.

[0065] It should be noted that after expiratory gas delivery, breathing is maintained (or "held") by the patient until the control means deactivates the external expiratory valve control tube / wire 99. Backflow from the patient to the ventilator via the ventilation circuit inlet connection 97 is inhibited by the output one-way valve assembly 62 or a one-way valve assembly integrated into the output end 61 of the volume and / or pressure controlled manual ventilator 10. Thus, a pause can be programmed between expiratory gas delivery to the patient and deactivation of the external expiratory valve.

[0066] The present invention can provide several additional parameters of ventilation delivery. For example, the present invention can provide continuous positive air pressure (CPAP) without actively delivering mechanically delivered exhaled air by adjusting the pressure received by the external compressed oxygen connection 95 and / or the external compressed air connection 96 and applying a back pressure means to the exhalation connection 98 of the ventilation circuit. This constant pressure helps to reduce the work of breathing when the patient breathes on his own, in order to maintain or rebuild the strength of the respiratory muscles.

[0067] Another important feature is positive end-expiratory pressure (PEEP), which is similar to CPAP in that a specified positive pressure is maintained in both tubes of the ventilation circuit at all times, except that PEEP is applied to patients who are unable to breathe spontaneously and ventilation is delivered by a volume- and / or pressure-controlled manual ventilator 10 driven by a power unit 30.

[0068] 11, a process 1100 for actuating a volume and / or pressure controlled manual ventilation device 10 is shown. The process 1100 begins in step 1102 with providing a housing 20 including an inner housing surface 22 and an outer housing surface 21. The inner housing surface 22 is configured to accommodate the manual ventilation device 10. In some embodiments, the inner housing surface 22 of the housing 20 includes one or more fastening points for an actuation mechanism.

[0069] The process 1100 continues at step 1104 with providing an actuation mechanism having a power unit 30 mechanically connected to the linear rod mechanism and one or more applicator pads 42 mechanically connected to the linear rod mechanism and located proximal to the compressible body of the manual ventilation device 10. For example, in some embodiments, the power unit 30 comprises an electric servo-type motor. In some embodiments, the power unit 30 comprises a dual channel pulley 39 configured to transmit rotational force to one or more belts or chains 31. In some embodiments, the linear rod mechanism is mechanically connected to one or more belts or chains 31 via one or more receiving pulleys 33.

[0070] In some embodiments, the linear rod mechanism has a first outer housing 35 mechanically connected to a first inner rod 36 and a second outer housing 35 mechanically connected to a second inner rod 36. For example, in some embodiments, a first applicator pad of the one or more applicator pads 42 is mechanically connected to the first inner rod 36 and a second applicator pad of the one or more applicator pads 42 is mechanically connected to the second inner rod 36. In some embodiments, a first applicator pad of the one or more applicator pads 42 is mechanically connected to the first inner rod 36 via a first transmission rod 41 and a second applicator pad of the one or more applicator pads 42 is mechanically connected to the second inner rod 36 via a second transmission rod 41.

[0071] The process 1100 continues with placing the manual ventilator 10 in the housing 20 in step 1106. The manual ventilator 10 has a compressible body, an output one-way valve 62 at an output end, and an input one-way valve 63 at an input end. In some embodiments, the manual ventilator 10 has an output connector 65 communicably connected to the output one-way valve 62. In some embodiments, the output connector 65 is configured to connect to a patient interface 66. In some embodiments, the manual ventilator 10 has a pressure relief valve 64 proximal to the output end.

[0072] Process 1100 continues with inputting automatic ventilation settings into the logic circuitry and / or microprocessor in step 1108. The automatic ventilation settings include a number of settings including tidal volume, as well as I time and ratio (or I:E ratio and ratio). This allows the manual ventilator 10 to be volume controlled without having to input duplicate tidal volume settings into the logic circuitry and / or microprocessor, and the manual ventilator tidal volume settings are applied throughout the automatic ventilation.

[0073] The process 1100 continues with converting the rotational motion of the power unit 30 into axial motion of the linear rod mechanism by the actuation mechanism in step 1110. The process 1100 concludes with applying pressure to the compressible body of the manual ventilation device 10 via one or more applicator pads 42 by the actuation mechanism in step 1112 such that the volume of the compressible body of the manual ventilation device 10 is contracted.

[0074] 12, a process 1200 for actuating a volume and / or pressure controlled manual ventilation device 10 is shown. The process 1200 begins in step 1202 with providing a housing 20 including an inner housing surface 22 and an outer housing surface 21. The inner housing surface 22 is configured to accommodate the volume and / or pressure controlled manual ventilation device 10. In some embodiments, the inner housing surface 22 of the housing 20 includes one or more fastening points for an actuation mechanism.

[0075] The process 1200 continues at step 1204 with providing an actuation mechanism having an electric or pneumatic power unit. The actuation mechanism is mechanically connected to one or more actuators, which are capable of compressing the compressible body of the volume and / or pressure controlled manual ventilation device 10. In some embodiments, the actuation mechanism includes a power unit 30 mechanically connected to a linear rod mechanism and one or more applicator pads 42 mechanically connected to the linear rod mechanism and proximal to the compressible body of the manual ventilation device 10. For example, in some embodiments, the power unit 30 includes an electric servo type motor. In some embodiments, the power unit 30 is attached to a dual channel pulley 39 configured to transmit a rotational force to one or more belts or chains 31. In some embodiments, the linear rod mechanism is mechanically connected to one or more belts or chains 31 via one or more receiving pulleys 33.

[0076] In some embodiments, the linear rod mechanism has a first outer housing 35 mechanically connected to a first inner rod 36 and a second outer housing 35 mechanically connected to a second inner rod 36. For example, in some embodiments, a first applicator pad of the one or more applicator pads 42 is mechanically connected to the first inner rod 36 and a second applicator pad of the one or more applicator pads 42 is mechanically connected to the second inner rod 36. In some embodiments, a first applicator pad of the one or more applicator pads 42 is mechanically connected to the first inner rod 36 via a first transmission rod 41 and a second applicator pad of the one or more applicator pads 42 is mechanically connected to the second inner rod 36 via a second transmission rod 41.

[0077] The process 1200 continues with, at step 1206, placing the volume and / or pressure controlled manual ventilator 10 in the housing 20. The manual ventilator 10 has a compressible body, an output one-way valve 62 at an output end, and an input one-way valve 63 at an input end. In some embodiments, the manual ventilator 10 has an output connector 65 communicably connected to the output one-way valve 62. In some embodiments, the output connector 65 is configured to connect to a patient interface 66. In some embodiments, the manual ventilator 10 has a pressure relief valve 64 proximal to the output end.

[0078] The process 1200 continues at step 1208 with inputting the automatic ventilator settings into the logic and / or microprocessor controlling the actuation mechanism such that the tidal volume setting for the volume and / or pressure controlled manual ventilator 10 is applied throughout the automatic ventilation. The process 1200 ends at step 1210 with the logic and / or microprocessor controlling the actuation mechanism applying pressure to the compressible body of the manual ventilator 10, thereby delivering a volume of gas specified by the tidal volume setting for the volume and / or pressure controlled manual ventilator 10 as the compressible body contracts. For example, in some embodiments, the actuation mechanism is configured to convert rotational motion of the power unit 30 into axial motion of a linear rod mechanism. In some embodiments, the actuation mechanism applies pressure to the compressible body of the manual ventilator via one or more applicator pads 42 such that the volume of the compressible body of the manual ventilator 10 contracts.

[0079] Those skilled in the art will recognize that the present invention can be embodied in other specific forms without departing from its spirit or essential characteristics. The foregoing embodiments are therefore to be considered in all respects as illustrative rather than limiting the invention described herein. It will be understood that the illustrated embodiments and those otherwise described herein are merely examples of the invention, and that other embodiments incorporating modifications, including combinations of the illustrated embodiments, are within the scope of the invention.

Claims

1. 1. A system for operating a volume and / or pressure controlled manual ventilation device, comprising: a manual ventilator having a compressible body, an output one-way valve at an output end, and an input one-way valve at an input end; a housing including an inner housing surface and an outer housing surface, the inner housing surface being configured to house the manual ventilation device; An actuation mechanism comprising: a power unit mechanically connected to the linear rod mechanism; a linear rod mechanism configured to convert rotational motion of the power unit into axial motion of the linear rod mechanism; an actuation mechanism having one or more applicator pads mechanically connected to the linear rod mechanism and proximal to the compressible body of the manual ventilation device; Equipped with The actuation mechanism is configured to apply pressure to the compressible body of the manual ventilator via the one or more applicator pads, thereby contracting a volume of the compressible body.

2. the manual ventilation device includes an output connector communicably connected to the output-side one-way valve; The output connector is configured to be connected to a patient interface. The system of claim 1 .

3. the manual ventilation device including a pressure relief valve proximal to the output end; The system of claim 1 .

4. the inner housing surface of the storage case includes one or more fastening points for the actuation mechanism; The system of claim 1 .

5. The power unit comprises an electric servo motor. The system of claim 1 .

6. the power unit is fitted with a dual channel pulley configured to transmit rotational force to one or more belts or chains; The system of claim 1 .

7. the linear rod mechanism is mechanically connected to the one or more belts or chains via one or more receiving pulleys; The system of claim 6.

8. The linear rod mechanism includes a first outer housing mechanically connected to a first inner rod and a second outer housing mechanically connected to a second inner rod. The system of claim 1 .

9. a first applicator pad of the one or more applicator pads is mechanically connected to the first inner rod; a second applicator pad of the one or more applicator pads is mechanically connected to the second inner rod; The system of claim 8.

10. the first applicator pad of the one or more applicator pads is mechanically connected to the first inner rod via a first transmission rod; the second applicator pad of the one or more applicator pads is mechanically connected to the second inner rod via a second transmission rod. The system of claim 9.

11. 1. A method for operating a volume and / or pressure controlled manual ventilation device, comprising: providing a housing including an inner housing surface and an outer housing surface, the inner housing surface configured to house a manual ventilation device; providing an actuation mechanism having a power unit mechanically connected to a linear rod mechanism and one or more applicator pads mechanically connected to the linear rod mechanism and proximal to a compressible body of the manual ventilation device; Installing the manual ventilation device in a storage case, the manual ventilation device having the compressible body, an output side one-way valve at an output end, and an input side one-way valve at an input end; inputting an automatic ventilation device setting, the tidal volume setting for the manual ventilation device being applied throughout the automatic ventilation; converting the rotational motion of the power unit into an axial motion of the linear rod mechanism by an actuation mechanism; contracting a volume of the compressible body by applying pressure to the compressible body of the manual ventilator via the one or more applicator pads; A method comprising:

12. the manual ventilation device includes an output connector communicably connected to the output-side one-way valve; The output connector is configured to be connected to a patient interface. The method of claim 11.

13. the manual ventilation device including a pressure relief valve proximal to the output end; The method of claim 11.

14. the inner housing surface of the storage case includes one or more fastening points for the actuation mechanism; The method of claim 11.

15. The power unit comprises an electric servo motor. The method of claim 11.

16. the power unit is fitted with a dual channel pulley configured to transmit rotational force to one or more belts or chains; The method of claim 11.

17. the linear rod mechanism is mechanically connected to the one or more belts or chains via one or more receiving pulleys; 17. The method of claim 16.

18. The linear rod mechanism includes a first outer housing mechanically connected to a first inner rod and a second outer housing mechanically connected to a second inner rod. The method of claim 11.

19. a first applicator pad of the one or more applicator pads is mechanically connected to the first inner rod; a second applicator pad of the one or more applicator pads is mechanically connected to the second inner rod; 20. The method of claim 18.

20. the first applicator pad of the one or more applicator pads is mechanically connected to the first inner rod via a first transmission rod; the second applicator pad of the one or more applicator pads is mechanically connected to the second inner rod via a second transmission rod.

20. The method of claim 19.

21. 1. A method for mechanically actuating a volume and / or pressure controlled manual ventilator, comprising: providing a housing including an inner housing surface and an outer housing surface, the inner housing surface configured to house a volume and / or pressure controlled manual ventilation device; providing an actuation mechanism including an electric or pneumatic power unit mechanically connected to one or more actuators capable of compressing a compressible body of said volume and / or pressure controlled manual ventilator; Placing the volume and / or pressure controlled manual ventilation device in a storage case, the manual ventilation device having the compressible body, an output side one-way valve at an output end, and an input side one-way valve at an input end; inputting automatic ventilation settings into a logic circuit and / or microprocessor controlling said actuation mechanism, wherein the tidal volume settings for said volume and / or pressure controlled manual ventilator are applied throughout the entire automatic ventilation; applying pressure to the compressible body of the manual ventilator by the logic circuit and / or microprocessor controlling the actuation mechanism, whereby a volume specified by the tidal volume setting on the volume and / or pressure controlled manual ventilator is delivered by compression of the compressible body during deflation; A method comprising:

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