This application claims priority to U.S. provisional patent application serial No. 60/957,383 filed on day 22, 8, 2007 and U.S. provisional patent application serial No. 61/014,312 filed on day 17, 12, 2007, the contents of which are incorporated herein by reference.
Background
The term "ventilator" is used herein to refer collectively to ventilators and ventilators, including various high frequency ventilators. In hospitals patients may need the assistance of a ventilator when they are unable to breathe themselves. Ventilators are expensive machines and, therefore, hospitals do not want to have a large number of excessive ventilators. The prevalence of the disease is relatively rare, but may be responsible for a number of casualty events. Three outbreaks of influenza have occurred in the last century, estimated to occur 32 times per 400 years. In an epidemic event, such as may be caused by a mutant of influenza H5N1, which has occurred in wild birds and poultry in asia, the number of patients requiring ventilators may exceed the number available. In the case of epidemics, the estimated number of shortages indicates a need for 30% to 200% or more ventilators. During such shortages, the physician may be faced with an unpleasant choice of stopping one patient from using the ventilator and leaving another patient to use, or refusing a new patient in danger to have ventilator support. In some cases, termination or failure to provide ventilator use, even temporarily, can cause the patient to recover for an extended period of time, harm the patient or even lose the patient's life.
A single ventilator can be used to support several patients simultaneously, thereby increasing the number of patients that can be treated, but the prior art does not prevent cross-contamination. That is, when several patients share the ventilator of the prior art, the diseases, bacteria and viruses carried by one patient may contaminate the environment and equipment used by other patients and may be directly transferred to other patients. Furthermore, the prior art of sharing one ventilator severely limits the ability to accommodate the individual respiratory support needs of each individual patient, as no machine has been provided that can individually accommodate each patient's respiratory needs, such as individualized tidal volume, peak pressure, oxygen concentration, and positive end expiratory pressure ("PEEP").
The use of a rebreathing circuit to allow two or more patients to share a ventilator aseptically has not been described in the prior introduction. U.S. patent No.6,675,799 ("the' 799 patent") describes a rebreathing device for isolating a single patient from his/her ventilator, caregiver, and environment. However, the' 799 patent does not disclose how to use a single ventilator to breathe more than one patient simultaneously. The' 799 patent also fails to state: (1) how to use a shared ventilator to reduce the patient's tidal volume below the volume provided to the device; (2) how to limit peak airway pressure below the shared ventilator setting; (3) how to personalize oxygen concentrations for multiple patients sharing a ventilator; (4) how to increase PEEP above the shared ventilator setting; or (5) how to conserve oxygen volume when several patients share a ventilator, all of which may be critical to the personalization of the patient settings during the sharing of the ventilator. In contrast, the isolation device according to the invention has the ability to change the state of the breathing gas supply, whereby the characteristics of the breathing gas received by a patient using a ventilator shared by several patients can be personalized. This ability to vary the conditions under which the disposable device is used to provide breathing gas to the patient makes the ventilator inexpensive and uncomplicated, and provides breathing gas to the patient with better prescribed pressure, volume, and oxygen concentration characteristics.
Additionally, ventilators are operated by mechanically ventilating the patient's lungs by increasing pressure in the patient's airway using a compressed air source. Generally, ventilators require compressed air and compressed oxygen, with the ratio being varied according to the patient's needs. Inexpensive ventilators, like those stored for epidemic prevention, may not be able to efficiently utilize the supplied gas. This deficiency is of no concern for compressed air, as mechanical compressors can be used to generate a continuous supply of compressed air on site in hospitals, even during periods of epidemic disease, without concern for a shortage of compressed air. However, compressed oxygen is typically produced by a remote gas supplier, typically supplied to the hospital as a compressed oxygen cylinder or liquid oxygen. In the epidemic, the shortage of compressed and liquid oxygen is a concern. Oxygen concentrators can be used to produce oxygen for spontaneously breathing patients, but they cannot be used with most ventilators because most ventilators require an inflow of compressed gas at a pressure higher than that produced by a typical oxygen concentrator. It would therefore be advantageous to have a system that reduces the amount of oxygen required for mechanical breathing by using only compressed air to expand the lungs and using an efficient rebreathing device to provide oxygen to the patient. There has not previously been a device that has described the use of inexpensive ventilators to store available oxygen in response to anticipated shortages of compressed oxygen or during more advanced ventilator shortages. The use of rebreathing devices to conserve oxygen helps meet these needs.
During a number of casualty events, a disposable isolation device is provided to store oxygen and convert an inexpensive, uncomplicated, oxygen-consuming ventilator into a viable, yet complex, oxygen-storing, isolated ventilator, which can aid life. This is not anticipated by the' 799 patent.
Detailed Description
The present invention may be embodied as a device for isolating a ventilator between one or more patients. Fig. 1 shows an isolation device 10 according to the present invention. The isolation device 10 may have a housing 13 disposed about a movable partition 16. The movable partition 16 may be connected to the housing 13 and may have a patient side 22 of the movable partition 16 and an actuation side 25 of the movable partition 16. The movable partition 16 may be in the form of a flexible bag. The isolation device 10 may include an inlet pressure regulator 82 in fluid communication with the actuation side 25. The inlet pressure regulator 82 may regulate the pressure of breathing gas allowed on the actuation side 25. The inlet pressure regulator 82 may also limit the pressure on the actuation side 25 to a desired maximum value ("peak pressure"). The isolation device 10 may include an outlet pressure regulator 84 in fluid communication with the patient side 22 of the movable partition 16. The outlet pressure regulator 84 can regulate the pressure within the housing 13 on the patient side 22 during exhalation and can be used to generate a PEEP on the patient side 22, for example, by restricting the flow of gas out of the housing 13 on the patient side 22, the PEEP being different from the pressure of the ventilator and, therefore, maintaining a higher positive end-expiratory pressure than the pressure set on the ventilator.
The housing 13 may also have a ventilator port 28 in fluid communication with the actuation side 25, which is adapted to pneumatically communicate with a ventilator 29. The housing 13 may also have a patient intake port 31 in fluid communication with the patient side 22, which is adapted to pneumatically communicate with a patient. The housing 13 may have a biased inflow orifice 33 in fluid communication with the patient side 22 that is adapted to pneumatically communicate with a source of fresh inspiratory gas 80. The housing 13 may have an expiratory return orifice 36 in fluid communication with the patient side 22. The isolation device 10 may also include a CO in fluid communication with the patient side 222Scrubber 55 to reduce CO in the gas returned to the patient during rebreathing2The level of (c). Such a scrubber 55 may be positioned such that breathing gas flowing out of the housing 13 flows through the scrubber 55 into the patient during inspiration and/or such that breathing gas flowing out of the patient flows through the scrubber 55 into the housing 13 during expiration. Fig. 4 shows one scrubber 55 connected to "patient 1" by means of an expiratory line 96 and another scrubber 55 connected to "patient 2" by means of an inspiratory line 98.
Fig. 2 shows that the invention can also be implemented as a shared system 15 of breathing gas. In such a system 15, a ventilator 29 and at least two isolation devices 12 are provided. The ventilator 29 may be connected to the inlet 16 of each isolation device 12 by means of a breathing path 42. The isolation device 12 may be any of a number of types of devices known in the art, such as the type disclosed in the' 799 patent, or the types described above. Fig. 3 schematically shows another embodiment of the breathing gas sharing system 17, wherein four isolation devices 12 are shown. A patient may be associated with one isolation device 12.
FIG. 4 shows a respiratory gas supply system 20 according to another embodiment of the present invention. The system 20 in this figure shows two patients breathing through a single ventilator 29 using two isolation devices 40 that are functionally similar to those described above. Each housing 13 may be made of more than one piece, for example, the portion of the housing 13 on the patient side 22 may be one piece and the portion on the actuation side 25 may be another piece. The portion of the housing 13 on the patient side 22 may absorb fresh gas from the fresh gas source 80. The flow of fresh gas mayThe fresh gas may be changed by a processor 99, controlled by a fresh gas controller 78. The processor 99 may be, for example, an evaporator, a sprayer, a stirrer, a mixer, a humidifier, or any combination of these devices. FIG. 4 shows that the patient may be connected to a rebreathing circuit that may include check valves 66, 63 and CO2A scrubber 55.
In operation, the ventilator 29 may be configured to provide: (1) peak pressure and required positive end expiratory pressure ("pressure mode"); or (2) the required tidal volume and positive end expiratory pressure ("tidal volume mode"). In pressure mode operation, isolation device 40 may be set to the peak pressure and positive end expiratory pressure of ventilator 29, and the patient will receive a tidal volume determined by his chest volume. If more than one isolation device 40 (and therefore more than one patient) is connected to ventilator 29 in the pressure mode, any particular patient will receive a tidal volume determined by the volume of that patient's chest. However, in such a situation, the tidal volume supplied to the patient may not be appropriate for that patient; for example, peak stress may cause too low a tidal volume for a particular patient, thus providing insufficient oxygen to the patient, or removing insufficient carbon dioxide from the patient. To avoid this situation, the peak pressure may be selected so that the most difficult patient to breathe is also able to breathe adequately, but assuming that the peak stress does not exceed some safe upper limit (e.g., 35 to 50 cm water column height).
The peak pressure provided to a particular isolation device 10 may be reduced below the peak pressure of the ventilator 29 using an inlet pressure regulator 82 (fig. 1), which regulator 82 may partially or completely block the breathing pathway 42, which pathway 42 connects the ventilator 29 to the isolation device 10. Fig. 5 shows one such inlet pressure regulator 82 that uses a ventilator path blocking clamp 86 to act on a flexible tube 88. An adjustable signal may be provided to the inlet pressure regulator 82, for example, by a pressure sensor 87. Reopening of the inlet pressure regulator 82 may be initiated by a subsequent signal, for example, in response to the pressure of the ventilator 29 dropping below the pressure of the isolation device 10, which may be measured by the downstream pressure sensor 45, for example. Such a pressure drop within the ventilator 29 (below the pressure of the isolation device 40) may occur upon initiation of a preset exhalation cycle of the ventilator 29 if the inlet pressure regulator 82 has closed the tube 88.
In the system 20 of the present invention, the ventilator 29 may be used as a timing device to set the breathing cycle and power the mechanical breathing of one or more of the patient's lungs via the isolation device 40. For this reason, ventilator 29 need not be an expensive, advanced device, as isolation device 40 may control patient-specific parameters, such as patient tidal volume, peak airway pressure, and PEEP. It should therefore be appreciated that the ventilator 29 may be, inter alia, a mechanical ventilator, a manual ventilator such as an ambu bag, or a continuous positive airway pressure ("CPAP") device that provides only a constant positive airway pressure.
The ventilator 29, particularly inexpensive models, may use large amounts of gas to perform the breathing function. In addition, these devices may be "leaky," in that a certain amount of gas provided to the ventilator may be lost due to leakage or other deficiencies, and thus, may not be completely provided to the patient. When a ventilator is supplied with supplemental oxygen, which is a short-term supply of gas, leakage can cause the supplemental oxygen to be inefficiently used. In the system 20 of the present invention, the ventilator 29 may use the indoor air from the compressor to move the partition 16 in the isolation device 40. This may reduce the need to provide a possibly inefficient ventilator 29 with compressed air and compressed oxygen, which may be required when using the ventilator 29 to directly breathe the patient without using the isolation device 40. When compressed air from the ventilator 29 is used to move the dividers 16 in the isolation devices 40, the oxygen requirements of each patient can be met by providing supplemental oxygen directly to each isolation device 40, which can be used more efficiently within the isolation devices 40. The fresh gas source 80 may include a system that can supply oxygen from a liquid oxygen cylinder, a compressed gas cylinder, or an oxygen concentrator. The fresh gas flow rate may be independently selected for each isolation device 40. The fresh gas flow rate may be selected to complete the supply of gas to the lungs to achieve an optimal peak pressure with the ventilator path occlusion caliper 86 closed. To do so, the occlusion caliper 86 may remain open when the ventilator 29 is available to provide inspiratory gas to the patient, and the occlusion caliper 86 may be closed when the ventilator 29 reaches a predetermined pressure, e.g., its peak pressure, and the flow of fresh gas may be used to increase the tidal volume above the volume advanced by the ventilator 29.
The processor 99 may be, for example, a blender to mix oxygen and air to personalize the oxygen concentration in the gas supplied to the portion of the isolation device 40 on the patient side 22. The rebreathing circuit can be used to more fully utilize the fresh gas entering the portion of the isolation device 40 on the patient side 22. Using a rebreathing circuit, the system 20 can use a low fresh gas flow, which can reduce the amount of oxygen used to a fraction of what would otherwise be required.
To control the positive end expiratory pressure, the signal to the inlet pressure regulator 82 may also be used to control the exhaust pressure regulator 84 (see fig. 1 and 6) to block the gas exhaust line 72 (see fig. 1 and 2) and prevent the partial exhaust of gas from the isolation devices 10, 40 on the patient side 22 during inspiration. Alternatively, a Starling resistor may be used to regulate the release of gas from the portion of the isolation device 10, 40 on the patient side 22, such that a Starling resistor may be connected so that the pressure within the isolation device 10, 40 must exceed the pressure within the ventilator circuit in order for the vented gas to exit the portion of the isolation device 10, 40 on the patient side 22. Figures 7A and 7B illustrate such a Starling resistor 46 in a closed configuration and an open configuration, respectively, wherein the flow of gas from the resistor inlet 47 to the resistor outlet 48 is controlled by pressure in a control line 49. In use, the resistor inlet 47 of the Starling resistor 46 may be connected to the portion of the isolation device 10, 40 on the patient side 22, while the resistor outlet 48 may be connected to the exhaust line 72, and the control line 49 may be connected to the ventilator path 42, between the housing 13 and the inlet pressure regulator 82. A manually adjustable PEEP valve 89 is located before or after the Starling resistor or caliper, and this valve 89 can be used to adjust the PEEP up to a level above the setting of the ventilator 29 when it is necessary to modify the patient's PEEP to exceed the setting of the ventilator 29. This may have additional benefits: emptying of the portion of the isolation device 10, 40 on the actuation side 25 may be facilitated before the next inhalation, ensuring consistency of the supplied tidal volume. In an alternative embodiment shown in fig. 10, the PEEP valve may be located within the ventilator path 42.
In the embodiment shown in fig. 6, the specific pressure differential between the pressure of the partition 16 on the patient side 22 (P3) and the pressure of the partition 16 on the actuation side 25 (P2) may be measured, and then a threshold may be used to trigger an event that reduces the inflow of gas from the ventilator 29 to the isolation device 50 by blocking the ventilator path 42, thereby setting the tidal volume and positive end expiratory pressure of the patient. Such a pressure difference may be caused, for example, by a position biaser, such as a cord 34 having two ends, a first end connected to the movable partition 16 and a second end connected to the housing 13. In addition to creating a pressure differential across the divider, the position biaser may create a restoring force to return the movable divider 16 to its rest shape and position. In another example, the pressure differential across the movable partition 16 and the restoring force may be caused by the elasticity of the movable partition 16 or an attachment thereto, for example, if the movable partition 16 is made of a material that includes an elastic material such as latex. The pressure differential across the movable partition 16 may be used to control either the fresh gas controller 78 or the inlet pressure regulator 82. The pressure differential created by such a restoring force is generally proportional to the degree of displacement of the moveable partition 16 and is therefore a suitable indicator of tidal volume. The pressure drop within the ventilator 29 (P1) that follows the initiation of the ventilator outflow cycle may create a pressure differential across the inlet pressure regulator 82 that may be used as a signal to reopen the inlet pressure regulator 82.
Air leaks may occur in patients, or may occur at airway junctions, for example, around endotracheal tubes. Pressure P3 on patient side 22 can be used to detect and respond to air leaks on patient side 22 or around patient connections when breathing passage 42 is blocked. When a rebreathing circuit is used, air leaks may create a need for a compensated flow of fresh gas to prevent pressure loss on the patient side 22. Pressure P3 on patient side 22 may be sensed and compared to an ideal value. When the pressure P3 is less than the desired value and the breathing path 42 is blocked, a leak of air may be indicated and the flow of fresh gas may be increased by sending a signal to the fresh gas inflow controller 78. This mechanism creates a new mechanical breathing pattern that can best be expressed as "leak compensation, pressure regulation, volume control".
The pressure P3 of the partition 16 on the patient side 22 may be sensed and compared to the pressure P1 of the ventilator 29 to control the timing of the blocking and reopening of the exhaust passage by means of an exhaust pressure regulator 84, which may include, for example, a Starling resistor, 84. For example, if the exhaust pressure regulator 84 is in a blocked state, after P3 is less than or equal to pressure P1, a transition is measured in which pressure P3 becomes greater than pressure P1, and then the exhalation cycle of the ventilator may be indicated and an actuation signal may be sent to the exhaust pressure regulator 84 to cause the exhaust pressure regulator 84 to open.
Other functions, including inflow of fresh gas and/or ventilator disconnection alarms, may be triggered by pressures P1, P2, and P3, or in dependence on the pressure relationships to each other. For example, if any of P1, P2, or P3 remains at 0psig during a time period when the pressure should be above or below 0psig, an alarm may sound indicating that the ventilator may be turned off or shut down. When using the position biaser 34, these functions may be triggered using strain gauges that trigger functions based on tension in the cords of the position biaser 34 rather than pressure differentials. Fig. 10 shows the breathing path 42 and enclosure 13, showing an example in which the pressure sensors 87, 43, 41 may be positioned to measure the difference between P1, P3, and P2 and P3, respectively.
Fig. 8 shows an isolation device 90 of the present invention having a gas flow rate meter 85. The gas flow meter 85 can be in gas communication with the actuation side 23 andmay be connected between the inlet pressure regulator 82 and the ventilator 29. In such an embodiment, the gas flow meter 85 may measure the tidal volume during inspiration, and after the required tidal volume has been provided, the gas flow meter 85 may cause the inlet pressure regulator 82 to block the "path". The controller circuit 44 may be connected to a gas flow rate meter 85 and an inlet pressure regulator 82 to control the regulation of the inlet pressure regulator 82 using signals from the gas flow rate meter 85. Gas flow meter 85 may also be placed between patient suction orifice 31 and patient side 22, or the CO placed in the patient and patient exhalation line2Between the scrubbers 55. Such a gas flow meter 85 may be used to measure the tidal volume of inspiration and expiration of the patient. The difference in tidal volume of inspiration and expiration may indicate a leak within the system and/or may be used to control the fresh gas controller 78 to adjust the inflow of fresh gas.
In fig. 9, yet another embodiment of the present invention is shown. In the isolation device 30 of this embodiment, the movable partition 16 is shown as a diaphragm 23 and a bellows 24. A position indicator 26 may be provided on the diaphragm 23 that may be used to generate a trigger signal to open or close the inlet pressure regulator 82, the exhaust pressure regulator 84, the fresh gas controller 78 for the inflow of fresh gas, and/or a ventilator disconnect alarm. The position indicator 26 may be a strain gauge mounted on the cord or between the moveable partition 16 and the housing 13. Alternatively, fig. 9 shows that the position indicator 26 may be an optical or magnetic commander having a transmitter 92 attached to the movable partition 16 and a receiver 94 capable of detecting the position of the transmitter 92.
The invention may also be embodied as a method of sharing a single ventilator between at least two patients. Fig. 11 illustrates such a method. The method according to the invention may comprise the steps of: the method includes the steps of providing a ventilator 100, providing a first isolation device 110, providing a second isolation device 120, driving a breathing cycle in each of the first and second isolation devices with the ventilator 130, and providing mechanical breathing to the lungs of the first patient with the first isolation device and providing mechanical breathing to the lungs of the second patient with the second isolation device 140. The first and second isolation devices may be of many types known in the art, such as the type disclosed in the' 799 patent, or as described above. The first and second isolation devices may each be equipped with or without an inlet pressure regulator and/or an exhaust pressure regulator. The inlet and/or exhaust pressure regulators may be used to modify the supply conditions, e.g., pressure and volume of gas supplied to the patient's lungs for mechanical breathing, based on the conditions at which the ventilator supplies gas to drive the breathing cycle.
Fig. 12 illustrates a method for changing ventilator characteristics consistent with an embodiment of the present invention. The method according to the invention may comprise the steps of: providing a ventilator step 200, providing an isolation device comprising an inlet pressure regulator and an exhaust pressure regulator step 210, driving the isolation device with the ventilator step 220, and providing mechanical breathing to the patient's lungs with the isolation device step 230. The inlet pressure regulator and/or the exhaust pressure regulator may modify the supply conditions, e.g., pressure and volume of gas supplied to the patient's lungs for mechanical breathing, based on characteristics of the gas supplied by the ventilator to drive the breathing cycle.
It will now be appreciated that the present invention provides a system and method that allows one or more patients to breathe aseptically using a single ventilator. Furthermore, it will be appreciated that by providing an isolation device that can adjust tidal volume, oxygen fraction and PEEP individually, one or more patients can be breathed using an inexpensive ventilator. The system also isolates the ventilator from infected patients to reduce the risk of infection to respiratory medical personnel cleaning and deploying the ventilator. The system may also allow for a reduction in the amount of oxygen used, which may be helpful in the event of a shortage of oxygen supply, for example, in a mass casualty event.
Although the present invention has been described with reference to one or more particular embodiments, it should be understood that other embodiments of the invention may be made without departing from the spirit and scope of the invention.