JP2006524543A5 - - Google Patents

Description

Ventilator and method for reducing intracranial pressure and low blood circulation

(Related patents)
This cancer, April 28, 2003 with the submission of the United States Patent Application No. 10/426, which is a continuation-in-part application of No. 161, June 11, 2003 with the submission of the United States Patent Application No. 10/460, 558 No. which is a continuation-in-part application of, September 2003 11 dated filed U.S. Patent application No. 10/660, a continuation-in-part application of 462 items, by reference to complete disclosure of these patent applications are herein in It is used.

This gun further 2004 dated 26 January filed U.S. Patent Application No. 10/765, it is also associated with No. 318, also in the present specification and incorporated by reference the complete disclosure of this patent application ing.

(Technical field)
The present invention relates generally to the fields of intracranial pressure and intraocular pressure. More particularly, the present invention is, for example intracranial pressure caused by traumatic head injury and other damage, intraocular pressure, reduces the dynamic pulse pressure systemic, apparatus and method for increasing organ perfusion vital About.

In general, head trauma and concussion are considered the leading cause of childhood and adolescent morbidity and mortality in the United States. Trauma to the head often results in brain enlargement. Since skull is impossible to expand, which can cause death or serious brain loss flaws by increased pressure in the brain.

While many treatments, including hyperventilation and steroids, to reduce brain hypertrophy have been evaluated, effective treatment of intracranial pressure remains an important medical challenge. Similarly, multiple organ loss wounds associated with organ damage necessary to maintain head trauma or other life is associated with decreased perfusion of an organ needed to increase the brain pressure and life support. These patients have a very high mortality rate, which remains a major medical challenge.

In certain embodiments, the present invention provides devices that reduce intracranial or intraocular pressure and increase systemic blood pressure and organ perfusion. The device includes a housing with an inflow opening and an outflow opening adapted to connect with an individual's airway. The device further includes a valve system operable to regulate the flow of breathing gas through the housing and into the individual's lungs during spontaneous or artificial respiration. For those who require artificial inspiration, the valve system can be attached to a vacuum source. This valve system helps blood from the head by helping to reduce the intrathoracic pressure during spontaneous inspiration while not actively breathing, and to reduce the intrathoracic pressure of apnea patients in the same state. The pressure in the venous blood vessels to be delivered is continuously or intermittently reduced to reduce intracranial pressure or intraocular pressure and increase systemic blood pressure. In addition, the present invention helps increase effective cardiac function by reducing pressure in the left and right hearts when positive pressure ventilation is not being supplied. Thus, the present invention can be used to treat patients suffering from a number of disease states, including but not limited to increased intracranial and intraocular pressure, collapse of the circulatory system, cardiac arrest, heart failure.

Furthermore, such a device can also be used to facilitate movement of cerebrospinal fluid . In this case, the intracranial pressure is further reduced. Therefore, such a device can be used for a person suffering from a head injury associated with an increase in intracranial pressure and a person suffering from a heart disease that increases the intracranial pressure.

In embodiments, the valve system, in order to reduce the intracranial pressure or intraocular pressure, intrathoracic pressure negative is about -2cmH2O~ about - reaches a pressure in the range of 20CmH2O, freely breathing gas to the lungs of individuals It is configured to open to flow. This reduces the negative intrathoracic pressure until a threshold pressure is reached, at which point the valve opens. By repeating this cycle continuously or periodically, the intrathoracic pressure repeatedly decreases. This device may be provided with means for improving blood circulation in the patient's body in a poorly circulated or cardiac arrest state by compressing the chest. This compression can be achieved by automatic chest compressions, chest vests, and others. This improves blood flow to the heart and brain of patients with poor blood circulation.

  The device may further comprise means for artificial inhalation through the valve system. For example, the device can utilize electrodes, iron lung ventilators, chest lifts, ventilators, and others.

In another embodiment, the device may comprise means for reducing intrathoracic pressure by applying a vacuum in the airway. The vacuum can be adjusted in relation to frequency, amplitude trachea. As a result, the intracranial pressure decreases in proportion to the degree of vacuum applied. Therefore, the intracranial pressure can be lowered by simply operating the airway pressure to reduce the intrathoracic pressure. In addition, the vacuum created in the thorax increases venous blood flow back to the heart, while at the same time increasing the heart rate and perfusion necessary to maintain life throughout the body .

  The device further includes a mechanism for changing the impedance level of the valve system. This can be used in combination with at least one physiological sensor configured to monitor at least one physiological parameter of the individual. In this way, the mechanism for changing the impedance level can be configured to receive a signal from the sensor and to change the impedance level of the valve system based on this signal. Examples of sensors that can be used include sensors that measure respiratory volume, intrathoracic pressure, endotracheal pressure, blood pressure, heart rate, end-tidal carbon dioxide concentration, oxygen level, intracranial perfusion, intracranial pressure.

  In certain aspects, the coupling mechanism can be used to couple the valve system to an individual's airway. Examples of coupling mechanisms include a mouthpiece, an endotracheal tube, and a face mask.

  A wide range of valve systems can be used to reduce an individual's intrathoracic pressure. For example, usable valve systems include spring-loaded devices, automatic, electronic or mechanical systems for opening and closing valve holes, duckbill valves, ball valves, and other, voluntary Included is a pressure sensitive valve system that can open a closed valve when exposed to a low pressure differential induced by an external system (eg, a ventilator, diaphragmatic nerve stimulator, iron lung, etc.) that manipulates breathing and / or intrathoracic pressure.

In another embodiment, the present invention provides a method of reducing intracranial pressure or intraocular pressure. According to this method, a valve system is coupled to the individual's airway and is configured to at least periodically reduce or prevent inflow of respiratory gas into the individual's lungs. Using a valve system coupled to the airway, the individual's negative intrathoracic pressure is repeatedly reduced, which is then repeatedly reduced to a lower pressure in the venous blood vessels that carry blood from the head. . In this case, intracranial pressure and intraocular pressure are reduced. Such a method further promotes cerebrospinal fluid movement. In this case, the intracranial pressure further decreases. This method can further be used to treat individuals suffering from head trauma associated with increased intracranial pressure and those suffering from heart diseases that increase intracranial pressure, such as atrial fibrillation and heart failure.

  The individual's negative intrathoracic pressure can be repeatedly reduced as the individual repeatedly inhales through the valve system. This can be done by the individual with self-effort (referred to as spontaneous breathing) or by repeatedly inhaling the patient artificially through the valve system. For example, repeatedly stimulating the phrenic nerve, manipulating the chest with an iron lung ventilator, creating negative pressure in the rib cage using a ventilator, applying a vacuum that can be regulated by a valve system in the rib cage, By supplying a high frequency ventilator at a rate of 200 to about 2000 times / minute, or otherwise, an individual can be artificially inhaled through the valve system.

  In another aspect, the level of impedance of the valve system can be fixed or variable. If variable, at least one physiological parameter of the individual can be measured and the impedance level can be changed based on the measured parameter.

  Various techniques using mouthpieces, endotracheal tubes, face masks, etc. can be used to couple the valve system to the airway. Further, preventing the inflow of respiratory gas into the lungs through the valve system until the valve system reaches a negative intrathoracic pressure in the range of about 0 cmH 2 O to about −25 cm H 2 O that allows the flow of respiratory gas to the lungs. it can.

  In another embodiment, the present invention provides a method of treating an individual suffering from a head injury associated with increased intracranial pressure. According to this method, positive pressure breathing is sent to the individual. Following positive pressure breathing, breathing gas is expelled from the individual's airways to create an intrathoracic vacuum. Thereby, the pressure in the venous blood vessel which sends out blood from a head falls, and an intracranial pressure falls. The treatment is continued by repeating the step of sending positive pressure breathing and the step of exhausting breathing gas.

  In certain aspects, delivery of positive pressure breathing and venting of breathing gas is performed using a mechanical ventilator. The breathing gas can be expelled by constant or pulsed expulsion.

  In a further aspect, the breath can be delivered once in the range of about 250 milliseconds to about 2 seconds. Furthermore, breathing can be delivered at a rate in the range of about 0.1 liter / second to about 5 liter / second. In another aspect, the vacuum can be maintained at a pressure level in the range of about 0 mmHg to about −50 mmHg. The vacuum can be maintained with negative flow or without flow. The positive pressure breath delivery time associated with the time to expel breathing gas may be in the range of about 0.5 to 0.1.

  Exhaust gas can be drained using a variety of instruments including mechanical ventilators, diaphragmatic nerve stimulators, ventilator bags, vacuum attached to airway devices, iron lung artificial respirators, and others. In some cases, a threshold valve can also be coupled to an individual's airway. This threshold valve may be configured to open when the adult negative intrathoracic pressure exceeds approximately −3 cm H 2 O. When used in pediatrics, the valve can be opened when the pressure exceeds about -2 cmH2O to about -5 cmH2O. This will reduce the negative intrathoracic pressure as the individual inhales.

  Various methods can be used to deliver and expel respiratory gas. For example, the breathing gas can be vented to achieve a pressure of about −5 mmHg to about −10 mmHg and maintain this pressure approximately constant until the next positive pressure breath. As another example, positive breathing can be delivered slowly, and the intrathoracic pressure can be rapidly reduced to a pressure of about −10 mmHg to about −20 mmHg and then gradually reduced to about 0 mmHg. As a further example, the intrathoracic pressure can be slowly reduced to a pressure of about −20 mmHg.

  In a further embodiment, the present invention provides a device for reducing intrathoracic pressure. The apparatus includes a housing that provides an interface adapted to couple the housing to a person's airway. A vacuum source is in fluid communication with the housing to expel breathing gas from the individual's lungs and airways in order to create a negative intrathoracic pressure and position it periodically. A vacuum controller is used to regulate the venting of respiratory gases from the patient's lungs and airways. In addition, a positive pressure source is in fluid communication with the housing to intermittently provide positive pressure breathing to the individual. Such devices can be used to treat various diseases including head trauma associated with increased intracranial pressure, hypotension, poor blood circulation, low blood volume, cardiac arrest and heart failure.

  In some cases, a switching mechanism can be used to stop breathing gas exhaust while sending positive pressure breaths. Various switching mechanisms such as mechanical devices, magnetic devices, electronic devices can be used. In addition, it uses a variety of vacuum sources including mechanical ventilators, vacuum with vacuum control, diaphragmatic nerve stimulation devices, extrathoracic vests, ventilator bags, iron lung ventilators, suction lines, venturi devices attached to oxygen tanks, etc. The breathing gas can be discharged.

  A threshold valve can be placed in fluid communication with the individual's airway to regulate the vacuum. The threshold valve may be configured to open when the individual's negative intrathoracic pressure reaches about −3 cm H 2 O to about −20 cm H 2 O to allow breathing gas to flow into the individual's air movement. In addition, positive pressure breaths can be delivered using various pressure sources such as mechanical ventilators, handheld valve resuscitators, mouse-to-mouse, or means to provide intermittent positive pressure ventilation. is there.

  In a broad sense, the present invention provides devices and techniques for reducing intracranial pressure and intraocular pressure. Such devices and techniques are particularly useful for patients with traumatic brain injury and patients with low blood flow and blood pressure. One method of maintaining or increasing tissue pressure while reducing pressure in the head is to use a valve system that is coupled to the individual's airways and used to reduce intrathoracic pressure. In this way, the valve system can be used to accelerate the removal of venous blood from the brain and consequently reduce intracranial and intraocular pressure. At the same time, tissue pressure increases due to increased venous blood return to the heart. It is also possible to use other techniques, such as intermittently creating a vacuum in the thorax. By reducing intracranial pressure, cerebrospinal fluid movement is also expanded. In doing this, the intracranial pressure is further reduced, thus improving the treatment of patients with head trauma. In some cases, the valve system can also be used to treat the brain function of an individual suffering from a heart disease (atrial fibrillation, heart failure, cardiac tamponade, etc.) that results in increased intracranial pressure. Such heart diseases include, for example, atrial fibrillation or heart failure. Reducing intracranial pressure increases cerebrospinal fluid movement and displacement, helping to increase brain function.

Intracranial pressure is limited by the amount of cerebral perfusion pressure determined by arterial blood pressure to the head, intracranial pressure, and pressure in the venous system that drains blood from the brain. The device and method of the present invention can be used to expand the outlet of venous blood drained from the brain to reduce intracranial pressure. This device and method can be used for patients who are able to breathe spontaneously and who need assistance during ventilation. In this case, every time the patient inhales (in the case of an apneic patient, every time the pressure in the thorax is reduced below atmospheric pressure by operation), increasing the vacuum effect in the thorax, and The apparatus and method are used so that the pressure in the venous blood vessels that drain blood from the brain decreases each time it tries to inhale. As a result, a larger amount of venous blood is drained from the head than when the present apparatus and method are not used, and as a result, intracranial pressure and intraocular pressure are reduced. Furthermore, every time negative intrathoracic pressure occurs, venous blood returning to the heart increases, and circulation to organs necessary for life support increases, so cardiac output increases, and organs necessary for life support Improves perfusion. As such, the present invention can be used to help patients suffering from low cardiac output conditions and low blood pressure.

Various blocking or prevention mechanisms can be used to prevent or block the breathing gas from flowing out of the lungs, including those described in the following references, which are referred to herein. are incorporated by reference the complete disclosure of US Patent No. 5, 551, 420 Patent; No. 5, 692, 498; 6, 062, 219, EP 5, 730, No. 122; 6, 155 , 257 Patent; sixth, 234, 916 Patent; sixth, 224, 562 Patent, also, US patent application filed on August 19, 2002 No. 10/224, No. 263 ( "Systems and Methods for Enhancing Blood Circulation "case number 16354-000115), 10/401 filed March 28, 2003 , 493 ( "Diabetes Treatment Systems and Methods" Docket No. 16354-000116), the 09/966 submitted on September 28, 2001, 945, 09, filed on September 28, 2001 / 967 , 029. The valve system can be configured to completely prevent or resist breathing gas from entering the patient's body while the patient is inhaling. In the case of a valve system that completely blocks the flow of breathing gas, it can be configured as a pressure responsive valve that opens when a threshold negative intrathoracic pressure is reached.

For example, from about about 0cmH2O~ resistance to respiratory flows - it can be set to 25CmH2O, also can be the set in the variable or fixed. More preferably, the valve system can be configured to open when the negative intrathoracic pressure is in the range of about −2 cmH 2 O to about −20 cm H 2 O. Furthermore, the valve system can be used on a continuous or variable basis. For example, the valve system can be used every other normal breath.

Although not intended to be limiting, certain types of stop valves used to reduce intracranial and intraocular pressure include spring-loaded devices that open and close valve holes, automatic / electronic and mechanical means, duckbills Other pressure sensitive valve systems (eg, ventilators, diaphragmatic nerve stimulation) that open and close when exposed to low pressure differentials induced by either valves, ball valves, or external means to manipulate spontaneous breathing and / or intrathoracic pressure Devices, iron lungs, etc.).

  In the past, such threshold valve systems have the effect of increasing intrathoracic vacuum with subsequent cardiac contractions, so as to increase venous preload to the heart and to increase heart rate, stroke volume, blood pressure Has been used to raise In contrast, the technique of the present invention works by promoting the removal of blood from the venous side of the brain. When such a valve system is used, blood flow from the heart to the vital organs (including the brain) will increase, but the effect of the valve system on reducing intracranial pressure is In fact, it was unexpected because it was found that blood flow to the brain increased. However, the significant difference in venous blood pressure removed from the brain when using the valve system remained the same. Therefore, the total effect of the valve system can be obtained that the intracranial pressure can be reduced while increasing the blood flow in the brain.

With the valve system coupled to the individual's airway, inhalation through the valve system increases the negative intrathoracic pressure. If an individual is breathing spontaneously, they can simply breathe through the valve system. When an individual is in an apneic state, artificial techniques may be used using a variety of techniques, including electrical stimulation to the diaphragm, negative pressure ventilators such as body cuirass or iron lungs, and positive pressure ventilators that also generate a vacuum between positive pressure ventilators. Can induce inhalation. As an example, at least a few respiratory muscles, and in particular, these respiratory muscles are stimulated and repeatedly contracted to increase the degree of negative intrathoracic pressure and allow the person to inhale through the valve system. Can be prolonged, i.e., by stimulating the respiratory muscles, the period and extent to which the intrathoracic pressure is reduced or shaded relative to the pressure in the surrounding venous vasculature. When the respiratory muscles to contract, generally the patient's breathing is "prompting Sako". These techniques can be used alone or in combination with a valve system.

  Among respiratory muscles, diaphragms and chest wall muscles including intercostal muscles and abdominal muscles can be stimulated and contracted. Certain chest wall muscles that can be stimulated and contracted include Leslie A. et al., The full disclosure of which is incorporated herein by reference. As described in Geddes, "Electroventilation-A Missed Opportunity?", Biomedical Instrumentation & Technology, July / August 1998, pages 401-414, including oblique and sternocleidomastoid muscles To raise the ribs, including those that raise the ribs, including trapezius, rhomboid, scapular levator, those that function to fix the shoulder band, saw major, major and small pectoral muscles Includes what works. The two hemidiaphragm and intercostal muscles of the respiratory muscle are thought to be the largest contributor to inspiration and expiration. The respiratory muscles can be stimulated to contract by various methods. For example, the diaphragm can be stimulated to contract by supplying an electric or magnetic field to various nerve or muscle bundles that contract the diaphragm upon stimulation. Similar techniques can be used to stimulate and contract the chest wall muscle. Various pulse trains, pulse widths, pulse frequencies, and pulse waveforms can be used to perform the stimulation. Furthermore, it is possible to change the electrode location and the pulse propagation timing. In certain embodiments, the phrenic nerve is stimulated directly or indirectly by providing a current gradient or magnetic field.

In order to apply electrical stimulation to the inhalation motor nerve, an electrode is placed on the side of the diaphragm nerve on the side of the neck, on the chest surface that is just to the side of the lower sternum, and the current is applied to the diaphragm just before the upper chest. Upon entry, current is preferably transmitted to the diaphragmatic nerve so that the thoracic nerve can be stimulated in the oropharyngeal region of the throat, or in the larynx itself. However, it will be understood that other electrode sites may be employed. For example, in one embodiment, the respiratory muscles are stimulated by percutaneous electrode impact along the anterior latissimus dorsi of the rib cage. In some embodiments, one or more electrodes attached to the endotracheal tube or pharyngeal tube are used to stimulate respiration muscles to induce respiration. To stimulate the diaphragm, the diaphragm nerve can be stimulated in the vicinity of C3-C7, for example in the neck range between C3, C4, or C5, or where the diaphragm nerve enters the diaphragm. Another technique for stimulating diaphragm contraction includes magnetic field stimulation of the diaphragm or diaphragmatic nerve. The chest wall muscle can also be stimulated using magnetic field stimulation. For electric field stimulation of the diaphragm or chest wall muscle, one or more electrodes are placed on the skin, preferably near the neck or the lower thorax (or anywhere else), and a voltage gradient including transcutaneous current is applied to the electrodes. Supplying in between stimulates and contracts the respiratory muscles. Still further, percutaneous electrodes can be used to stimulate respiratory muscle contraction. Other techniques are described in U.S. Patent No. 6, 463, 327 No., in this specification are incorporated by reference in full disclosure.

  The valve system can have a fixed working pressure or can be variable so that the resistance to flow can be reduced if the desired negative intrathoracic pressure is reached. Furthermore, the valve of the present invention can be configured to be variable to operate manually or automatically. The magnitude of resistance to flow can be varied based on physiological parameters measured by one or more sensors associated with the individual being treated. In this way, resistance to flow can be altered so that the individual's physiological parameters are within acceptable limits. When using an automated system, such a control device employed to control one or more mechanisms that change the resistance or operating pressure of the inlet valve described in the references incorporated by reference may be used. You may connect with a sensor.

  Thus, the valve system of the present invention can incorporate or be associated with sensors used to detect intrathoracic pressure or other physiological parameters. In certain aspects, the sensor can be configured to wirelessly transmit the measured signal to a remote receiver in communication with the controller. It is also possible to use the controller to measure a signal that alters the operation of the valve system described or incorporated herein by reference. For example, blood pressure, intracardiac pressure, intrathoracic pressure, positive end expiratory pressure, respiratory rate, intracranial pressure, intraocular pressure, respiratory flow, oxygen delivery, temperature, blood pH, end expiratory carbonic acid concentration, tissue carbonic acid concentration, blood oxygen, Sensors can be used to sense cardiac output, etc. Signals from these sensors are wirelessly transmitted to the receiver. The controller can then use this information to control the operating pressure or resistance of the inlet valve, as described in the references incorporated by reference herein.

Techniques for reducing intracranial pressure can be used in a variety of settings. For example, these techniques can be used for individuals who are breathing spontaneously, individuals who are in apnea, but whose heart is beating, and individuals who are in cardiac arrest. In the latter case, cardiopulmonary resuscitation (CPR)
These techniques can be used with means for intermittently creating a vacuum in the thorax. This can be done using a valve system or some other type of pressure manipulation system. Furthermore, such a system can be used in other settings, such as when an individual is breathing.

FIG. 1 is a flow diagram illustrating one method for reducing intracranial or intraocular pressure. As shown in step 10, the process begins by coupling the valve system to the individual's airway. Any type of coupling mechanism can be used, such as a mouthpiece, endotracheal tube, face mask, etc. In addition, any valve system described or incorporated herein by reference can be used. In step 20, the individual's negative intracranial pressure is repeatedly reduced (due to artificial or spontaneous breathing). Examples of techniques for artificially reducing negative intracranial pressure include iron lung ventilators, ventilators capable of generating negative pressure, ventilators capable of supplying high frequency vibrations at a rate of about 200 to about 2000 per minute, diaphragm Includes neurostimulators and other uses. As the individual's negative intracranial pressure repeatedly decreases while the valve system is coupled to the airway, the pressure in the venous blood vessels that drain blood from the head also decreases. By doing so, intracranial pressure and intraocular pressure are reduced.

As shown in step 30, various physiological parameters of the individual can be optionally measured. Examples of such parameters include respiratory rate, intrathoracic pressure, intratracheal pressure, intracranial pressure, intracranial blood flow, intraocular pressure, blood pressure, heart rate, end expiratory carbonic acid concentration, oxygen saturation, and others. Further, as shown in step 40, the actuation threshold level of the valve system can optionally be changed based on the measured physiological parameter. This can be done to maximize the amount of blood drawn from the brain or simply to monitor the patient's condition so that the patient can remain stable.

FIG. 2 shows the face mask 100 in combination with the valve system 200. The mask 100 is configured to be fixed to the patient's face for the purpose of covering the mouth and nose. Mask 100 and valve system 200 are examples of one type of instrument used to reduce intracranial pressure and intraocular pressure by reducing intrathoracic pressure. However, it will be understood that other valve systems, such as those referenced above, and other coupling arrangements may be used. Accordingly, the present invention is not intended to be limited to any particular valve system and mask described below.

The valve system 200 will be described in further detail with reference to FIGS. The valve system 200 includes a valve housing 202 with a socket 204 that receives a ball 206 of a ventilation tube 208. In this way, the ventilation tube 208 can rotate about the horizontal axis and pivot about the vertical axis. A respiratory source, such as a ventilation bag, can be coupled to the tube 208 to assist in ventilation. In the ventilation tube 208, a filter 210 provided on the duckbill valve 212 is disposed. A diaphragm holding device 214 for holding the diaphragm 216 is provided in the housing 202. The valve system 200 further includes a patient port 218 that is held in place by the second housing 220. The housing 220 is conveniently provided with a tab 222 that facilitates the coupling of the valve system 200 and the face mask 100. Further, a check valve 224 having a spring 224a, a ring member 224b, and an O-ring 224c is provided in the housing 220. Spring 224a biases ring member 224b against patient port 218. Patients port 218 is provided with a bypass opening 226, the bypass opening 226, until the compression of the spring 224a pressure patient port 218 is reached a threshold negative pressure, it is coated with O-ring 224c of the check valve 224 The

When the patient actively ventilates, breathing gas is forced through the ventilation tube 208. The gas flows through the filter 210, through duckbill valve 212, forcibly raising the diaphragm 214, Ru is discharging gas from port 218. This allows the patient to be ventilated at any time by simply forcing the breathing gas through the tube 208.

  During the exhalation phase of one respiratory cycle, exhaled gas passes through port 218 and lifts diaphragm 214. This air then flows through the passage 227 in the ventilation tube 208 and is exhausted from the system through the opening 229 (see FIG. 3).

During the inspiratory phase of one respiratory cycle, the valve system 200 prevents breathing air from entering the lungs until a threshold negative intrathoracic pressure level is exceeded. When this pressure level is exceeded, the spring 224a is compressed and the check valve 224 is pulled down so that the breathing gas passes through the opening 226 and first through the tube 208 and the duckbill valve 212, so that the patient Flows into the lungs. The valve 224 can be set to open when the negative intrathoracic pressure is in the range of about 0 cm H2O to about -25 cm H2O, more preferably in the range of about -2 cm H2O to about -20 cm H2O. This allows the frequency and duration of the negative intrathoracic pressure to be increased while the patient is inhaling using the valve system 200. When the intrathoracic pressure is reduced to less than the threshold value, place it 224a is again to close the check valve 224 to recoil. In this case, the pressure in the venous blood vessels that send blood from the brain also decreases. By doing so, more blood is drawn from the brain, and the intracranial pressure and intraocular pressure can be reduced.

Any of the valve systems described herein can be incorporated into a treatment system 300 as shown in FIG. System 300 may conveniently include face mask 100 and valve system 200, but any valve system or communication mechanism described herein , or others may be used. Valve system 200 may be conveniently coupled to controller 310. The controller 310 can be used to control the impedance level of the valve system 200 in a manner similar to any embodiment described and incorporated herein. The level of impedance can be changed based on measurements of physiological parameters or using a programmed change schedule. System 300 may be a wide variety of sensors and / or measurement devices for measuring any physiological parameter described herein. These sensors or measuring devices can be integrally formed or coupled within the valve system 200 or face mask, or provided separately.

  For example, the valve system 200 can be a pressure transducer for making pressure measurements (such as intrathoracic pressure, intracranial pressure, intraocular pressure, etc.), a flow measuring device that measures the flow rate of air flowing into and out of the lung, or an exhaled device. A carbon dioxide sensor for measuring the carbon dioxide may be provided.

Examples of other sensors or measuring devices include a heart rate sensor 330, a blood pressure sensor 340, and a temperature sensor 350. These sensors are further coupled to the controller 310 so that the measured values can be recorded. Further, by using the other of the measuring device, such as oxygen saturation and / or in blood O2 levels, blood lactate, blood pH, lactate in the tissue, tissue pH, blood pressure, the pressure within the heart, Measure various physiological parameters such as intrathoracic pressure, positive end expiratory pressure, respiratory rate, intracranial pressure, intraocular pressure, respiratory flow, oxygen delivery, temperature, end expiratory carbonic acid concentration, tissue carbon concentration, cardiac output, etc. Can do.

In some cases, using the control unit 310 can perform control of the valve system 200, control of any sensor or measuring device, records the measurement values, the implementation of any comparison. Alternatively, a set of computers and / or control devices can be used in combination to perform such operations. The instrument can be provided with a suitable processor, display screen, input and output devices, entry devices, memory or database, software, and other equipment necessary to operate the system 300.

  Various devices can also be coupled to the controller 310 to allow an individual to artificially breathe. For example, such a device may comprise a respiratory device 360, an iron lung ventilator 370 or a diaphragmatic nerve stimulator 380. The respirator 360 may create a negative intrathoracic pressure in the individual's body, and may be a high pressure respirator capable of generating about 200 to about 2000 vibrations per minute.

Example 1
The following are non-limiting examples illustrating the method for reducing intracranial pressure in accordance with the present invention. In this example , a pig weighing 30 kg was anesthetized with propofol. The intracranial pressure of a spontaneously breathing pig was continuously measured using a Millar electronic catheter inserted under the dura mater with a micromanometer at the tip. Intrathoracic pressure (ITP) was recorded using a Millar catheter placed at the level of the thoracic ridge in the trachea. After stabilizing the blood pressure of the pig, heart rate, respiratory volume, intracranial pressure (ICP), and intrathoracic pressure were recorded at 0 mH 2 O respiratory impedance and then at 5, 10, 15, 20 cm H 2 O respiratory impedance. Respiration impedance was achieved using an impedance threshold valve (ITV) as described in FIGS.

  The intracranial pressure at the bottom was about 8/4 mmHg. As shown in FIG. 7, when the amount of respiratory impedance was increased, the intracranial pressure decreased in proportion to this. The intracranial pressure when the pig inhaled an impedance of 20 cm H2O was 6 / -2 mmHg. These results have been observed in several pig studies and are reproducible. A 3 mm Millar catheter was inserted into the pig brain. Intracranial pressure secondary increased due to trauma associated with probe insertion. The intracranial pressure increased to 25/22 mmHg on a new basis. The impedance threshold valve was then evaluated at different resistance levels (FIG. 8). Again, the intracranial pressure decreased in proportion to the frequency of respiratory impedance.

Example 2
In this example , intracranial pressure increased in the setting for recovery from cardiac arrest. In this example , a porcine model was used in which cardiopulmonary resuscitation was performed for 6 minutes after undergoing ventricular fibrillation for 6 minutes, and then defibrillated. When the animal used a valve system similar to Example 1 and breathed through a 10 cm H 2 O respiratory impedance, spontaneous pressure reduced the intracranial pressure to a maximum of 50%.

In all of the above-described examples , the intrathoracic pressure was reduced relative to other body parts, resulting in a suction effect that reduced the pressure in the venous blood vessels that drain blood from the brain, resulting in a decrease in intracranial pressure. .

The present invention further provides techniques and devices for reducing intracranial pressure (ICP) by promoting fluid movement of cerebrospinal fluid ( CSF ). There are many causes of increased ICP, including, for example, head injury, ischemia, osmolar instability, cerebral edema, tumor, dialysis difficulties, infection, seizures, hypertensive crisis. Each of these can cause a slow rise in ICP, and in some cases, a sudden rise. The solid content of the brain accounts for about 80-85% of the content sealed by the skull. Cerebral blood volume accounts for 3-6% and CSF 5-15%. Annesthesia, Third Edition Editor, Ron Miller., Which is hereby incorporated by reference in its entirety. Chapter authors: Shapiro and Drummond. See Chapter 54 (1990). CSF moves uninhibited under normal physiological conditions from its site of production in the brain to the site of reabsorption into the brain. Since the brain content is substantially compressed inability three major components (the brain substance, blood volume, CSF volume) by any one of the capacity of the changes, the other two elements A relative change occurs in one or both. When the brain volume increases secondary with the increase in non-CSF component (s), some of the CSF will enter the large occipital foramen (the skull that connects the skull with the space where the spinal cord is located). Forcibly moved to another site including the hole) and further into the CSF space surrounding the spinal cord. Increasing the capacity and size of non-CSF components increases intracranial pressure. Normal ICP levels in the inactive state are 10-15 mmHg. At levels higher than 15-20 mm Hg, secondary damage to the brain can occur with compression and the resulting tissue ischemia (lack of adequate blood flow). Reduction of ICP levels can be achieved by a number of clinical interventions including water intake regulation, urination promotion, steroids, hyperventilation, cerebral venous pressure, cooling methods, CSF excretion, and surgical decompression.

ICP rise causes CSF fluid movement and displacement. Regardless of ICP elevation, CSF fluid production remains generally constant (about 150 ml / day). By increasing the ICP, the liquid reabsorption of CSF can be delayed. By using the valve systems described herein, it is possible to reduce the middle cardiac vein pressure. This reduces ICP and increases CSF fluid movement or displacement and reabsorption. As a result, ICP further decreases.

The valve system of the present invention, individuals subjected to spontaneous breathing, the patient is subjected to ventilation in the shade pressure ventilation, the patient undergoing ventilation ventilator to reduce the centered venous pressure for at least a portion of the respiratory cycle Can be used. Each time the intrathoracic pressure is reduced by the valve system of the present invention, the accompanying ICP is lowered and the fluid movement of the CSF is increased. In other words, the difference between the peak and valley of the ICP waveform is magnified when using a valve system. For the pressure in through a venous vessel were sent to the brain thorax changes, sinusoidal transfer occurs to the person has a spontaneously breathing. Normally, CSF pressure that is moving irregularly (pressure increases and decreases with each breath) is changed by the valve system. More specifically, the valve system creates a lower trough valve, which causes an overall change in ICP with each breath. For patients with apnea, iron lung, diaphragmatic nerve stimulator (eg, those described in US Pat. Nos. 6,234,985; 6,224,562, 6312399, incorporated herein by reference), chest Similar effects can be produced using this valve system with a variety of ventilators, including suction cups on the chest used for regular enlargement, and others.

Increased CSF fluid movement improves the overall metabolic state of the brain. This is schematically shown in FIGS. 9A and 9B. In FIG. 9A, the brain 400 is in a normal state. Brain 400 is surrounded by CSF402 generated in parts position 404. In addition, the CSF is surrounded by a skull 406. Blood enters the brain 400 through the artery 408 and exits the brain through the vein 410. Further, the vein 410 includes a portion 412 that drains CSF . In FIG. 9A, the arrow which shows the flow direction of CSF at the time of discharge | emission is shown. Extending from the brain 400 is a spinal cord 414 surrounded by a large occipital foramen 416.

In FIG. 9B, because the brain 400 is significantly enlarged, the space 402 containing the CSF is reduced. The enlargement of the brain 400 may prevent the flow of CSF flowing to the spinal cord 414 as indicated by the arrow 418. Further, the movement of CSF to site 412 to prevent movement of CSF exiting skull 406 is reduced.

Treating the elevated ICP associated with all the conditions described above using the valve system described herein can reduce brain hypertrophy. This increases CSF movement and fluid displacement under the same conditions. As a result, when the CSF can move again, the intracranial pressure further decreases.

Next, the effect of heart atrial contraction on ICP will be described with reference to FIG. As shown in the figure, the ICP moves stepwise by the contraction of the atrium. This can be most clearly demonstrated during cardiac ventricular fibrillation. In this setting, often atria spontaneously beating, each of the pressure of contraction and relaxation waveform is rapidly propagated to the brain is reflected in ICP at approximately the same waveform. The inventor of the present invention has found that even a slight change in heart rhythm causes an immediate change in CSF pressure because the fluid systems (venous vessels and CSF) are so closely connected. Thus, in some patients suffering from significant heart rhythm or significant heart failure, ICP may increase as a result of increased right heart pressure caused by these conditions. Although it is possible to reduce the cerebral perfusion by the rise of such ICP, which, cerebral perfusion pressure of the blood exiting the brain from the blood pressure (mean arterial pressure) that flows into the brain (ICP and centered venous pressure This is because it is determined by a numerical value obtained by subtracting). By using the valve and intrathoracic vacuum system described herein, intrathoracic pressure is reduced. As shown in FIG. 10, the downward-pointing arrows indicate the timing of each intake through the valve system. In the reference state, before starting atrial fibrillation, inhalation (short arrows) ITP is reduced for each, and reduced right heart pressure, centered venous pressure decreases, then, ICP decreases immediately. When atrial fibrillation starts, the intracranial pressure rises and the sine pattern of ICP amplitude change attenuates. Animals, soon to start the intake through the intake impedance -10CmH2O, intrathoracic pressure (ITP) decreases rapidly, decreases rapidly right heart bunches (RA) pressure, also in the ICP for each intake As the sine wave recovers, the intracranial pressure (ICP) quickly decreases. In a state where ICP is elevated, ICP is lowered by inhaling through the blocking means, cerebrospinal fluid flow is increased, and cerebral ischemia is secondarily reduced as brain perfusion increases. Thus, these valve systems reduce ICP, reduce CSF fluid movement and CSF for patients suffering from cardiac rhythms such as atrial fibrillation, or patients suffering from heart failure with elevated ICP. It can be used to increase the displacement and ultimately to help improve the brain function of these patients.

Thus, the amount of inspiratory resistance, or negative intrathoracic pressure generation (which can be generated using various techniques) is controlled by feedback of measurements of ICP, blood pressure, respiratory rate, or other physiological parameters or Can be regulated. Such a system includes a closed loop feedback system.

  FIG. 11 is a flow chart illustrating another method for treating a patient suffering from a head injury with increased intracranial pressure. It will be appreciated that such techniques are particularly applicable to the treatment of patients suffering from hypotension or cardiac arrest. These techniques are particularly useful when the individual is in an apneic state, but in some cases can also be used for breathing patients.

In a broad sense, when treating a patient suffering from a head injury, the intracranial pressure is reduced by reducing the individual's intrathoracic pressure. This helps to reduce secondary brain damage. As shown in step 500, coupling an instrument to an individual can assist in reducing the individual's intrathoracic pressure. As described in U.S. Patent No. 6, 584, 973 Patent, the discharge is possible mechanical ventilator breathing gas, U.S. Patent No. 6,234,985; which is described in No. 6,463,327; No. 6,224,562; No. 6,312,399 phrenic nerve or other muscle stimulation device (U.S. Patent No. 5, 551, 420 Patent as; 5, 692, 498; 6, 062, 219 Patent; No. 5, 730, No. 122; 6, 155, No. 257; No. 6 , 234 , 916; whether or not the blocking mechanism described in No. 6 , 224 , 562 is used), iron lung device, pulling the chest wall outward, similar to the effect of iron lung of the rib cage vacuum it is possible to create a breast best, the specification of the application and the same day of the 2003 September 11, dated in the filing of US Patent application No. 10/660, No. 366 A wide range of instruments and techniques can be used to reduce intrathoracic pressure, including ventilation bags and other uses as described in (Case Number 16354-005400). All of these references are incorporated herein by reference. In the case of a breathing patient, using the threshold valve as described above and set to open when approximately 5 cm H 2 O is generated during inhalation, the person's negative intrathoracic pressure Can be increased.

If the individual is in an apnea state, a positive pressure breath is sent to the individual as shown in step 502. This can be done using mechanical ventilators, ventilation bags, mouse-to-mouse ventilation, and others. After this operation, the intrathoracic pressure quickly decreases. This can be done by expelling or eliminating respiratory gas from the patient's lungs, as shown in step 504. Any of the techniques described above can be used to reduce intrathoracic pressure. By reduction of such a intrathoracic pressure also decreases centered venous pressure and intracranial pressure further.

The vacuum effect during the breathing phase may be constant, time-varying, or pulsed. Examples of different methods for creating a vacuum are described later in connection with FIGS. 12A-12C. The initial positive pressure breath is delivered for a time of about 250 milliseconds to about 2 seconds, more preferably about 0.75 seconds to about 1.5 seconds . Breathing gas only is extracted but between the time of about 0.5 to about 0.1 with respect to time of the positive pressure breathing. Positive pressure breathing can be delivered at a flow rate between about 0.1 liter / second and about 5 liter / second, more preferably between about 0.2 liter / second and about 2 liter / second. The exhalation flow (eg, mechanical ventilator) may range from about 0.1 liter / second to about 5 liter / second, more preferably from about 0.2 liter / second to about 2 liter / second. The vacuum can be maintained with the negative flow or alone. The vacuum may be in the range of about 0 mmHg to about −50 mmHg, more preferably about 0 mmHg to about −20 mmHg.

  As shown in step 506, the process of sending a positive pressure breath and then rapidly reducing the intrathoracic pressure can be repeated as necessary to control the intracranial pressure. When this is finished, the process is completed at step 508.

The method of generating positive pressure breathing and vacuum may vary according to the particular application. These can be applied in various waveforms with different periods and slopes. Examples include those using square wave, biphasic (in this case, positive pressure follows vacuum generation ), attenuation (in which case attenuation is possible after the vacuum is generated ), etc. 12A to 12C show three examples of how they occur, but other examples are possible. For ease of explanation, the time for positive pressure breathing to occur is defined in relation to the inspiratory phase, and the time for intrathoracic pressure to decrease is defined in relation to the expiratory phase. Positive pressure breathing occurs at about 10 to about 16 breaths / minute, where the inspiratory phase is about 1 . The breathing phase lasts from about 3 to about 5 seconds, lasting from 0 to about 1.5 seconds. As shown in FIG. 12A, breathing gas is delivered at a high rate up to a pressure of about 22 mmHg. This is quickly reversed to a negative pressure of about -10 mmHg. If the cycle is repeated, this pressure will remain relatively constant until the expiration phase ends.

  In FIG. 12B, positive pressure is applied more slowly. When the pressure reaches about 10 to about 15 mmHg, this pressure is rapidly reversed to a negative pressure of about -20 mmHg. At the end of the exhalation phase, this negative pressure gradually decays to about 0 mmHg. Thereafter, this cycle is repeated. Therefore, in the cycle shown in FIG. 12B, the positive pressure is lower than the cycle of FIG. 12A, and the negative pressure is initially lower than that of FIG. 12A, but can gradually increase. This technique is designed to help reduce possible airway collapse.

  In FIG. 12C, the positive pressure is increased to about 20 mmHg and then rapidly decreased to about 0 mmHg. The negative pressure is then gradually increased to about −20 mmHg by the end of the expiration phase. This cycle is designed to help reduce possible airway collapse.

13A and 13B schematically illustrate an embodiment of a device 500 that can be used at a lower intrathoracic pressure in a patient who is in an apnea condition. The device 500 includes a housing 502 that includes an interface opening 504 that can be directly or indirectly coupled to the patient's airway using any type of patient interface. The housing 502 further includes a vacuum source interface 506 that may be in fluid communication with any type of device or system capable of generating a vacuum. Coupled to the housing 502 is a means for regulating the vacuum, such as a pressure reaction valve system 508. The device 500 further includes a ventilation interface 510 for delivering breaths to the patient as needed when no vacuum is applied.

In this embodiment, the vacuum may be provided by a vacuum source essentially any type, also the control unit may comprise a gate valve, the gate valve is described in US Patent No. 5, 551, 420 Patent; No. 5 , 692 , 498; No. 6 , 062 , 219; No. 5 , 730 , 122; No. 6 , 155 , 257; No. 6 , 234 , 916; No. 6 , 224 , 562; No. 6 No. 6 , 234 , 985; No. 6 , 224 , 562; No. 6 , 312 , 399; and No. 6 , 463 , 327, or other than those described herein. It may be. Various ventilation sources, such as a bag valve resuscitator, coupled to interface 510 can be used to deliver breaths. The apparatus 500 may further comprise a mechanism 512 for preventing a vacuum when delivering breaths from the bag valve resuscitator to the patient. As breaths are delivered, the mechanism 512 operates to allow re-application of a vacuum within the rib cage. The mechanism 512 of the vacuum source off, is used to switch on, and as shown in FIG. 13 B, providing a slide switch which moves so as to close the branching portion in the housing 500 within which is provided with a vacuum source Can do. However, other types of switches or mechanisms can be used. In some cases, the vacuum source may include a controller configured to shut off the vacuum when performing a breath so that mechanism 512 is not required. In addition, a controller and appropriate sensors can be used to sense when a breath is delivered and stopped so that the mechanism 512 can be properly operated by the controller. When breathing is delivered, the mechanism 512 returns to the position shown in FIG. When the vacuum reaches a threshold amount, the regulating device 508 operates to maintain the vacuum level at approximately the threshold amount.

  14A and 14B show another embodiment of an apparatus 530 that can be used to treat a patient. Device 530 operates using the same principle as device 500 shown in FIGS. 13A and 13B. Device 530 includes a housing 532 that includes a patient interface 534 that can be coupled to a patient's airway and a vacuum interface 536 that can be coupled to a vacuum source. The housing 532 further includes a ventilation interface 538 through which positive pressure breathing is supplied. Further, a vacuum control device 540 for regulating the amount of vacuum supplied to the patient is coupled to the housing 532. An example of a flow regulating device that can be used is described below with reference to FIGS. 15A and 15B. However, it will be understood that any of the flow restriction devices described herein may be used. Disposed within the housing 532 is a flow control device 542 for knitting the airflow flowing through the housing 532. The flow control device 542 may include a cylindrical member 544 that can slide within the housing 532 and between the interfaces 534 and 536 when the flow control device 542 is in the position shown in FIG. 14A. A flow path 546 is provided for allowing a gas to flow through. For convenience, the flow control device 542 is held in the basic position shown in FIG. 14A by a spring 548 or other biasing mechanism. The flow control device 542 further includes a flow path 550 for allowing a gas to flow between the regulating device 540 and the interface 536, which is indicated by an arrow in FIG. 14A. Therefore, at the basic position, a vacuum is supplied through the interface 536, which reduces the individual's intrathoracic pressure. When the vacuum increases, the gas flows through the regulating device 540, and the amount of vacuum is reduced.

  As shown in FIG. 14B, the flow control device 542 further includes a flow path 552 extending from the interface 538 to the interface 534. This allows positive pressure breathing to be delivered to the patient via the interface 538. More specifically, as gas is injected through interface 538, the gas flows through controller 542, which causes controller 542 to move within housing 532 and compress spring 548. At this time, the flow path 546 is closed when it is blocked by the housing 532. Furthermore, the flow path 550 is closed leaving only a flow path 552 that allows breathing gas to flow to the patient. When positive pressure breathing stops, spring 548 forces the flow control device back to the reference position, where the patient is again supplied with vacuum.

Thus, when a vacuum is applied from the interface 536, air is drawn from the patient via the interface 534 until the blowoff pressure of the blocking valve 540 is reached. At this point, air flow through the blocking valve 540 from the ventilation source at the interface 538, thereby, limits the vacuum that will be achieved in the patient's body is set. If positive pressure ventilation is sent from the ventilation source have you to interface 538, closing the vacuum source internal slide switch cylinder 542 is moved downward, thereby, an amount of positive pressure for supplying breathing patient Can be supplied. Flow control device 542 may comprise a cup-shaped opening 556 to assist the movement of the device 542 with minimal force that will be supplied. When breathing has arrived and no positive force has been transmitted from the ventilation source to the device 542, the spring 548 is pushed up, again exposing the patient to the vacuum source.

  Device 530 may further include an optional pressure pop-off regulating device 560. If the vacuum source is too large, the pop-off regulator 560 is opened and the pressure is relaxed above the desired vacuum pressure. The pop-off regulating device 560 can be configured to open at a pressure higher than about 20 to about 100 mmHg.

  Although the apparatus shown in FIGS. 13 and 14 is shown with a mechanical switching mechanism, other devices such as magnetic, electronic, and electrical switching mechanisms can be used. Other types of switches that can be used include ball valves, flapper valves, fish mouth valves, or other mechanical devices, including solenoids, to temporarily evacuate vacuum when positive pressure breathing arrives from a ventilation source. Means and electrical or electronic valve systems are included. Additional regulating devices can be added on the vacuum source to regulate the vacuum flow or force. For example, the vacuum source can be configured to supply a constant vacuum after reaching a threshold level. Further, the vacuum controller and blocking valves 508, 530 may be variable or set to a fixed blocking level. The vacuum source may further be a suction line or taken from a hazardous device attached to an oxygen tank, both supplying oxygen to the patient and the vacuum source. Also, the present invention is not limited to the use of the blocking valve shown here for regulating the vacuum. Instead, it is possible to use a plurality of switching means and regulating means. Further, the ventilation source is not limited, and a mouse-to-mouse ventilator, a bag valve resuscitator, an automatic ventilator, and the like may be provided.

  15A and 15B show the flow restriction device 540 in more detail. The restriction device 540 includes a housing 570 provided with a patient port 572 and a ventilation port 574. Optionally, an auxiliary oxygen port 576 can be provided. Gas flows through the housing 570 through one of the two flow paths (between ports 572 and 574). The first flow path is blocked by a one-way check valve 578 provided with a check valve gasket 580 and a spring 582. The second flow path is blocked by the diaphragm 584.

In operation, when a vacuum source draws a vacuum at port 536, a vacuum is experienced at patient port 572 (see FIG. 14A). When the vacuum reaches a threshold level, the spring 582 is compressed and moves the gasket 580 downward, thereby creating a flow path as shown in FIG. 15B. When the vacuum is drawn, the diaphragm 584 closes, preventing air from entering another flow path. As long as the vacuum is at the threshold level, the gasket 580 remains spaced from the opening. By doing so, it becomes possible for the regulating device 540 to maintain a certain level of vacuum.

  When the patient is ready for ventilation, the vacuum is turned off and breathing gas is injected into port 574 and / or port 576. These gases lift the diaphragm 584 to allow the gases to flow to the patient.

Example 3
Example 3 is another non-limiting example that illustrates reducing intracranial pressure and intrathoracic pressure and increasing systolic arterial pressure in accordance with certain aspects of the present invention. In this example , a pig weighing 30 kg was anesthetized with propofol. Using a pig in a apnea, a Millar Inc. electronic catheter fitted with a micro manometer used by inserting only 2cm under dura tip was measured intracranial pressure. Intrathoracic pressure (ITP) was recorded using a Millar catheter placed at the level of the thoracic ridge in the trachea. During systole, systolic arterial blood pressure (SBP) was measured with a Millar catheter. To regulate intrathoracic pressure, a system similar to FIGS. 14A, 14B, 15A, and 15B was used with inspiratory impedance (−8 cmH 2 O at a flow rate of about 30 L / min). Positive pressure ventilation was delivered at a rate of 10 breaths / minute using an automated transfer ventilator with a tidal volume of approximately 400 ml per 1.0 second. The following summarizes the purpose, method, results, and conclusions describing these novel cardiopulmonary-cranial interactions.

The purpose of this example is to reduce the intrathoracic pressure (ITP) and intracranial pressure (ICP) and mean arterial pressure (ICP) in a porcine model that is continuously injured by cardiac arrest and fixed hemorrhage hypotension shock. New inhalation impedance threshold device (ITD) controlled to increase MAP), cardiac perfusion pressure (CPP), cerebral perfusion pressure (CerPP), but attached to control a continuous vacuum (CV) source ) Is an important use evaluation. This animal model is associated with both elevated ICP after cardiac arrest and significant hypotension after bleeding.

In this example , six female farm pigs (28-32 kg) anesthetized with polopophore and intubated and ventilated to maintain normal carbon dioxide status and <90% O2 saturation were used. After induction of ventricular fibrillation, no treatment was provided for 6 minutes, standard CPR was applied for 6 minutes, and then defibrillation was performed. After spontaneous circulation returned and during mechanical ventilation at 10 breaths / min, 35% of the blood volume moved at a rate of 60 cc / min. Five minutes later, ITD-CV was applied for 5 minutes, and 100% oxygen was positively ventilated at a rate of 10 bpm. The ITD-CV was then removed and positive pressure ventilation was reapplied at a rate of 10 breaths / minute. Hemodynamic parameters and arterial blood gas were evaluated before, during and after ITD-CV application. Statistical analysis was performed by paired t-test and ANOVA to compare +/- ITD-CV usage.

  The results are summarized in the following table. As shown in the table, by limiting the thoracic pressure, the use of ITD-CV immediately reduces ITP and ICP, while at the same time MAP rises rapidly and CerPP rises significantly. Therefore, ITD-CV can be used for the treatment of hypotension, concussion, and cerebral hypertension.

ここまで、本発明を、明確化し、理解を深める目的で詳細に説明した。しかしながら、付属の特許請求項の範囲内で特定の変更および改良の実施が可能であることが理解されるだろう。

So far, the present invention has been described in detail for the purpose of clarification and better understanding. However, it will be understood that certain changes and modifications may be practiced within the scope of the appended claims.

FIG. 1 is a flow chart illustrating one method for reducing intracranial pressure and intraocular pressure according to the present invention. FIG. 2 is a perspective view of an embodiment of a face mask and valve system that can be used to reduce intracranial and intraocular pressure according to the present invention. FIG. 3 is a perspective view of the valve system of FIG. 4 is a cross-sectional view of the valve system of FIG. FIG. 5 is an exploded view of the valve system of FIG. FIG. 6 is a schematic diagram of a system for reducing intracranial pressure and intraocular pressure according to the present invention. FIG. 7 is a series of graphs showing the reduction of intracranial pressure in animal studies. FIG. 8 is a series of graphs showing the reduction in intracranial pressure in another animal study. FIG. 9A is a schematic diagram of an individual's brain in a normal state. FIG. 9B shows the brain of FIG. 9A with increased hypertrophy. FIG. 10 shows three graphs illustrating the effect of reducing intrathoracic pressure on intracranial pressure and right arterial pressure. FIG. 11 is a flowchart illustrating another method for reducing intracranial pressure and intraocular pressure according to the present invention. FIGS. 12A, 12B, and 12C show three graphs illustrating patterns for delivering positive pressure breathing and exhaling breathing gas according to the present invention. 13A and 13B schematically illustrate one device that can be used to reduce intrathoracic pressure in an apneic patient according to the present invention. 14A and 14B illustrate another device that can be used to reduce intrathoracic pressure in apneic patients according to the present invention. 15A and 15B illustrate an embodiment of a threshold valve system that can be used with the apparatus of FIGS. 14A and 14B.

Claims (35)

A system for treating a human, the system comprising:
Means for delivering positive pressure breathing to the human;
Means for creating an intrathoracic vacuum by exhausting respiratory gas from the human respiratory tract using a vacuum after positive pressure breathing, thereby reducing pressure in the heart and increasing blood flow back to the heart ; and means for controlling repeatedly the step of discharging the process as respiratory gas to send a positive pressure breathing,
A system comprising: The system of claim 1, wherein the human suffers from a disease selected from the group consisting of head trauma associated with elevated intracranial pressure, hypotension, low blood circulation , low blood volume, cardiac arrest, heart failure. . The system of claim 1, further comprising means for controlling the amount of intrathoracic vacuum using a threshold valve in fluid communication with the human airway. 4. The system of claim 3, wherein the threshold is configured to release when the human negative intrathoracic pressure reaches about -3 cm H2O to about 20 cm H2O to allow breathing gas to flow into the human airway. The system of claim 3, further comprising means for stopping the application of vacuum when applying positive pressure breathing using a switching arrangement. Wherein the means for sending positive pressure breathing, mechanical ventilator, handheld bag valve resuscitator, Ru is selected from the group consisting of means for supplying a mouse-to-mouse or intermittent positive pressure ventilation, according to claim 1, The system described in. The system of claim 1, wherein breathing gas is expelled by constant exclusion, time-varying exclusion, or pulse elimination. The system of claim 1, wherein the breath is delivered for a time ranging from about 250 milliseconds to about 2 seconds. The system of claim 1, wherein respiration is delivered at a rate in the range of about 0.1 liter / second to about 5 liter / second. The system of claim 1, wherein the vacuum is maintained at a pressure level of about 0 mmHg to about −50 mmHg. The system of claim 10, wherein the vacuum is maintained at or without negative flow. The system of claim 1, wherein the time at which positive pressure breathing is delivered in relation to the time at which breathing gas is expelled is in the range of about 0.5 to about 0.1. Means for discharging the breathing gas, mechanical ventilator, vacuum by the vacuum controller, phrenic nerve stimulator, extrathoracic best, ventilator bag, Ru is selected from the group consisting of iron lung ventilator according to claim 1 System . Means for discharging the breathing gas is reduced to the intrathoracic pressure of from about -5mmHg~ about -10 mmHg, then, is configured to be maintained substantially constant until the next positive airway pressure, to claim 1 The described system . Configured means so that feeding slowly for sending said positive breath, means for discharging breathing gas, decreases rapidly until the intrathoracic pressure about -5mmHg~ about -20 mmHg, then to about 0mmHg The system of claim 1, wherein the system is configured to degrade stepwise toward. The system of claim 1, wherein the breathing gas is slowly reduced to a pressure of about −5 mmHg to about 20 mmHg. A device for reducing intrathoracic pressure, the device comprising:
Means to connect with the patient's airway;
Means for repeatedly venting breathing gas from the patient's lungs and airways to create and maintain a negative intrathoracic pressure;
Means for repeatedly controlling the discharge of respiratory gases in the patient's lungs and airways;
Means for delivering positive pressure breaths to periodically deliver inspiration of breathing gas. The apparatus of claim 17, wherein the means for venting the breathing gas comprises a vacuum source selected from the group consisting of a suction line or a venturi device attached to an oxygen tank. 18. The switching mechanism of claim 17, further comprising a switching mechanism that stops breathing gas exhaust during a positive pressure breath, wherein the switching mechanism is selected from the group of mechanical devices, magnetic devices, and electronic devices. apparatus. 18. The device of claim 17, wherein the means for venting the breathing gas is selected from the group consisting of a mechanical ventilator, a vacuum with a vacuum controller, a diaphragmatic nerve stimulator, an extrathoracic vest, a ventilator bag, and an iron lung ventilator. 18. The apparatus of claim 17, wherein the control means includes a threshold valve in fluid communication with the human airway. 23. The apparatus of claim 21, wherein the threshold is configured to open when the human negative intrathoracic pressure reaches about -3 cm H2O to about 20 cm H2O to allow breathing gas to flow into the human airway. 18. The means for delivering positive pressure breaths is selected from the group consisting of mechanical ventilators, handheld bag valve resuscitators, mouse to mouse ventilation, or means for providing intermittent positive pressure ventilation. The device described in 1. A device for reducing intrathoracic pressure, the device comprising:
A housing providing an interface adapted to couple the housing with a human airway;
A vacuum source in fluid communication with the housing to repeatedly vent respiratory gas from the human lungs and airways to create and maintain a negative intrathoracic pressure;
A vacuum control device for controlling the discharge of respiratory gases from the human lungs and airways; and
A device comprising a positive pressure source in fluid communication with the housing to intermittently supply positive pressure breathing to the human. A device for reducing intracranial pressure or intraocular pressure, the device comprising:
A housing with inflow and outflow openings adapted to connect with the human airway;
A valve system operable to control the flow of breathing gas through the housing and into the human lung during spontaneous or artificial inspiration, wherein the valve system comprises intracranial pressure or An apparatus comprising a valve system that assists in reducing intrathoracic pressure during each inspiration to repeatedly reduce the pressure in a venous blood vessel that pumps blood from the head to reduce intraocular pressure. Although the valve system is normally closed, when the negative intrathoracic pressure reaches a pressure in the range of about 0 cmH 2 O to about −25 cm H 2 O to reduce intracranial or intraocular pressure, respiratory gases are passed into the human lung. configured to open as Ru freely flow, according to claim 25. 26. The apparatus of claim 25, further comprising means for artificially inhaling the human through a valve system. 28. The device of claim 27, wherein the means for artificially inhaling the human is selected from the group consisting of an electrode, an iron lung ventilator, a chest raising device, and a ventilator. 26. The apparatus of claim 25, further comprising a mechanism for changing the impedance level of the valve system. And further comprising at least one physiological sensor configured to monitor the at least one physiological parameter of the human, wherein the mechanism for changing the level of impedance receives the signal from the sensor, and the signal 30. The apparatus according to claim 29, wherein the apparatus is configured to change a level of impedance of the valve system based on. The sensor is selected from the group consisting of sensors configured to measure a parameter selected from respiratory volume, intrathoracic pressure, endotracheal pressure, blood pressure, heart rate, end expiratory carbonic acid concentration, oxygen level, intracranial pressure group; The apparatus of claim 30. 26. The apparatus of claim 25, further comprising a coupling mechanism configured to couple a valve system with the human airway. 33. The apparatus of claim 32, wherein the coupling mechanism is selected from the group consisting of a mouthpiece, an endotracheal tube, and a face mask. The valve system includes a fish mouth valve, a spring poppet valve, a ball valve, a flexible plug valve, a grooved airway resistance valve, a spring-biased valve, a movable disc valve, a compressible airway valve, an iris valve, an automatic valve 26. The apparatus of claim 25, comprising an inflow valve selected from a valve group consisting of a continuous regulator valve. A system for reducing intracranial pressure, the system comprising :
A system comprising means for actively reducing the negative intrathoracic pressure of the human to reduce pressure in a venous blood vessel that pumps blood from the head to reduce intracranial pressure.