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Systems and methods for modulating autonomic function

USPTO Application #: 20070277826
Title: Systems and methods for modulating autonomic function
Abstract: In one embodiment, a method for modulating a person's autonomic function comprises interfacing a valve system to the person's airway, the valve system being configured to decrease or prevent respiratory gas flow to the person's lungs during at least a portion of an inhalation event. The person is permitted to inhale and exhale through the valve system, wherein during inhalation the valve system functions to produce a vacuum within the thorax to transiently decrease intrathoracic pressure and thereby modulate the person's autonomic function. (end of abstract)
Agent: Townsend And Townsend And Crew, LLP - San Francisco, CA, US
Inventor: Keith G. Lurie
USPTO Applicaton #: 20070277826 - Class: 128205240 (USPTO)
Related Patent Categories: Surgery, Respiratory Method Or Device, Means For Supplying Respiratory Gas Under Positive Pressure, Valve, Or Valve Control, Structure
The Patent Description & Claims data below is from USPTO Patent Application 20070277826.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation in part application of U.S. application Ser. No. 10/660,462, filed Sep. 11, 2003, which is a continuation in part application of U.S. patent application Ser. No. 10/460,558, filed Jun. 11, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/426,161, filed Apr. 28, 2003, the complete disclosures of which are herein incorporated by reference.

[0002] This application is also a continuation in part application of U.S. patent application Ser. No. 10/401,493, filed Mar. 28, 2003, which is a continuation in part application of U.S. patent application Ser. No. 10/224,263, filed Aug. 19, 2002, which is a continuation in part application of U.S. patent application Ser. No. 10/119,203, filed Apr. 8, 2002, which is a continuation in part application of U.S. patent application Ser. No. 09/854,238, filed May 11, 2001, which is a continuation in part application of U.S. patent application Ser. No. 09/546,252, filed Apr. 10, 2000, which is a continuation of U.S. patent application Ser. No. 08/950,702, filed Oct. 15, 1997 (now U.S. Pat. No. 6,062,219), which is a continuation-in-part application of U.S. patent application Ser. No. 08/403,009, filed Mar. 10, 1995 (now U.S. Pat. No. 5,692,498), which is a continuation-in-part application of U.S. patent application Ser. No. 08/149,204, filed Nov. 9, 1993 (now U.S. Pat. No. 5,551,420), the disclosures of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

[0003] This invention relates generally to the field of intrathoracic pressures. More specifically, the invention relates to a variety of conditions that may be treated by manipulating intrathoracic pressures.

[0004] A widespread need exists for treating ailments associated with poor blood flow and low blood pressure. For instance, poor blow flow and low blood pressure may be linked to conditions such as poor wound healing, strokes, heart failure, anxiety disorders, sleep disorders and the like. Hence, this invention is related to the intentional manipulation of internal body pressures in order to treat these and a variety of other conditions.

BRIEF SUMMARY OF THE INVENTION

[0005] In one embodiment, the invention provides a method for modulating a person's autonomic function. According to the method, a valve system is interfaced to the person's airway. The valve system is configured to decrease or prevent respiratory gas flow to the person's lungs during at least a portion of an inhalation event. The person is permitted to inhale and exhale through the valve system. During inhalation the valve system functions to produce a vacuum within the thorax to transiently decrease intrathoracic pressure and thereby modulate the person's autonomic function. More specifically, by lowering the intrathoracic pressure, the person experiences enhanced venous return of blood to the heart, and this causes an increase in cardiac output, an increase in blood pressure, and increase in blood flow to the brain, a decrease in intracranial pressure, and an autonomic nervous system-modulated decrease in sympathetic tone resulting in a decrease in peripheral arterial resistance.

[0006] For such a treatment, the valve system may include a pressure responsive inflow valve having an actuating pressure of the valve in the range from about -2 cm H2O to about -30 cm H2O, and more preferably from about -3 cm H2O to about -12 cm H2O for flow rates of about 30 to about 50 liters per minute. In such cases, inhalation the valve system may function to decrease the person's heart rate and peripheral vascular tone. Also, as blood flow increases back to the right heart of the person, vital organ perfusion and function is enhanced. Another advantage is that heart rate variability may also be increased and sympathetic tone may be decreased. Such techniques may also be used to reduce the person's anxiety level and to treat shock secondary to hypovolemia, sepsis and heart failure. In some cases, the techniques may be used to treat sleep disorders, such as sleep apnea, and to treat states of hypo-perfusion, such as wound healing, stroke and diseases where blood flow is compromised, including coronary artery disease. In one particular treatment, the invention may be used to improve blood flow to the muscles and brain, thereby reducing heart rate and enhancing recovery from physical exertion. For example, as intrathoracic pressures are reduced, more heart filling and improved blood circulation results. The nervous system responds by reducing the heart rate and overall the body recovers more quickly. Such techniques may also be used before a person begins to exercise.

[0007] The invention also includes a device for modulating a person's autonomic function. The device comprises a housing having an opening that is adapted to be interfaced with the person's airway, and a valve system that is operable to regulate respiratory gas flow through the housing and into the person's lungs due to inhalation. The valve system is employed to assist in manipulating intrathoracic pressures during inhalation to produce a vacuum within the thorax to transiently decrease intrathoracic pressure and thereby modulate the person's autonomic function. The valve system may also be configured to permit respiratory gases to flow to the person's lungs when the negative intrathoracic pressure reaches a pressure in the range from about -2 cm H2O to about -30 cm H2O, and more preferably range from about -3 cm H2O to about -12 cm H2O in order to modulate the person's autonomic function.

[0008] In another embodiment, the invention provides a device for decreasing intracranial or intraocular pressures. The device comprises a housing having an inlet opening and an outlet opening that is adapted to be interfaced with a person's airway. The device further includes a valve system that is operable to regulate respiratory gas flows through the housing and into the person's lungs during spontaneous or artificial inspiration. The valve system assists in lowering intrathoracic pressures during inspiration to continuously or intermittently lower pressures in the venous blood vessels that transport blood out of the head to thereby reduce intracranial or intraocular pressures.

[0009] Such a device may also be used to facilitate movement of cerebral spinal fluid. In so doing, intracranial pressures may be further reduced. Such a device may therefore be used to treat those suffering from head trauma associated with elevated intracranial pressures as well as those suffering from heart conditions that increase intracranial pressures.

[0010] In one aspect, the valve system is configured to open to permit respiratory gasses to freely flow to the person's lungs when the negative intrathoracic pressure reaches a pressure in the range from about -2 cmH2O to about -20 cmH2O in order to reduce intracranial or intraocular pressures. In this way, the negative intrathoracic pressure is lowered until a threshold pressure is reached, at which time the valve opens. The cycle may be repeated continuously or periodically to repetitively lower intrathoracic pressures.

[0011] The device may also include means for causing the person to artificially inspire through the valve system. For example, the device may utilize an electrode, an iron lung cuirass device, a chest lifting device, a ventilator or the like.

[0012] In another embodiment, the device may comprise a means to reduce intrathoracic pressure by applying a vacuum within the airway. The vacuum may be adjusted in terms of frequency, amplitude, and duration. This results in a decrease in intracranial pressure in proportion to the degree of vacuum applied. Hence, intracranial pressures may be reduced simply by manipulating airway pressures to reduce intrathoracic pressures.

[0013] The device may further include a mechanism for varying the level of impedance of the valve system. This may be used in combination with at least one physiological sensor that is configured to monitor at least one physiological parameter of the person. In this way, the mechanism for varying the level of impedance may be configured to receive signals from the sensor and to vary the level of impedance of the valve system based on the signals. Examples of sensors that may be used include those that measure respiratory rate, intrathoracic pressure, intratracheal pressure, blood pressure, heart rate, end tidal CO2, oxygen level, intracranial perfusion, and intracranial pressure.

[0014] In one aspect, a coupling mechanism may be used to couple the valve system to the person's airway. Examples of coupling mechanisms include a mouthpiece, an endotracheal tube, and a face mask.

[0015] A wide variety of valve systems may be used to repetitively decrease the person's intrathoracic pressure. For example, valve systems that may be used include those having spring-biased devices, those having automated, electronic or mechanical systems to occlude and open a valve lumen, duck bill valves, ball valves, other pressure sensitive valve systems capable of opening a closing when subjected to low pressure differentials triggered either by spontaneous breathing and/or external systems to manipulate intrathoracic pressures (such as ventilators, phrenic nerve stimulators, iron lungs, and the like).

[0016] In another embodiment, the invention provides a method for decreasing intracranial or intraocular pressures. According to the method, a valve system is coupled to a person's airway and is configured to at least periodically reduce or prevent respiratory gases from flowing to the person's lungs. With the valve system coupled to the airway, the person's negative intrathoracic pressure is repetitively decreased to in turn repetitively lower pressures in the venous blood vessels that transport blood out of the head. In so doing, intracranial and intraocular pressures are reduced. Such a method also facilitates movement of cerebral spinal fluid. In so doing, intracranial pressures are further reduced. As such, this method may also be used to treat a person suffering from head trauma that is associated with elevated intracranial pressures as well as those suffering from heart conditions that increase intracranial pressures, such as atrial fibrillation and heart failure.

[0017] The person's negative intrathoracic pressure may be repetitively decreased as the person repeatedly inspires through the valve system. This may be done by the person's own efforts (referred to as spontaneous breathing), or by artificially causing the person to repeatedly inspire through the valve system. For example, the person may be caused to artificially inspire by repeatedly stimulating the phrenic nerve, by manipulating the chest with an iron lung cuirass device, by generating negative pressures within the thorax using a ventilator, by applying a high frequency ventilator that supplies oscillations at a rate of about 200 to about 2000 per minute, or the like.

[0018] In another aspect, the level of impedance of the valve system may be fixed or variable. If variable, at least one physiological parameters of the person may be measured, and the impedance level may be varied based on the measured parameters.

[0019] To couple the valve system to the airway, a variety of techniques may be used, such as by using a mouthpiece, an endotracheal tube, a face mask or the like. Further, the respiratory gases may be prevented from entering the lungs through the valve system until a negative intrathoracic pressure in the range from about 0 cmH2O to about -25 cmH2O is achieved, at which time the valve system permits respiratory gases to flow to the lungs.

[0020] In another embodiment, the invention provides a method for treating a person suffering from head trauma associated with elevated intracranial pressures. According to the method, a positive pressure breath is delivered to the person. Following the positive pressure breath, respiratory gases are extracted from the person's airway to create an intrathoracic vacuum. In turn, this lowers pressures in the venous blood vessels that transport blood out of the head to thereby reduce intracranial pressures. The steps of delivering positive pressure breaths and extracting respiratory gases are repeated to continue the treatment.

[0021] In one aspect, the delivery of the positive pressure breaths and the extraction of gases are performed using a mechanical ventilator. The respiratory gases may be extracted with a constant extraction or a pulsed extraction.

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