Patent Application
20120167878
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The present invention relates generally to system and methods for selective modification and control of a patient's body temperature. More particularly, it relates to a respiratory system and methods for raising and lowering a patient's body temperature by heat exchange with the patient's airways and lungs. The respiratory system provides rapid induction of therapeutic hypothermia by having the patient breathe a respiratory gas that carries with it frozen particles or a frozen mist to enhance heat capacity.
In one aspect of the invention, there is a cold breathing gas delivery system having a delivery device adapted to deliver a cooled breathing gas mixture to a patient; and an injection device positioned near a distal end of the delivery device. The injection device is configured release a fluid to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
In another aspect of the invention, there is a cold breathing gas delivery system having an endotracheal tube adapted to deliver a cooled breathing gas mixture to a patient; and an injection device positioned near a distal end of the endotracheal tube. In another aspect, the injection device is configured release a fluid to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
In still another aspect of the invention, there is a cold breathing gas delivery system having a nasal cannula adapted to deliver a cooled breathing gas mixture to a patient; and at least one injection device positioned near a distal end of the nasal cannula. In this aspect, the at least one injection device is configured release a fluid to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
In an additional aspect of the invention, there is a cold breathing gas delivery system that includes a tube sized to deliver a cooled breathing gas mixture to a throat of a patient and an injection device positioned near a distal end of the tube. In another aspect, the injection device is configured release a fluid to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
In another aspect of the invention, a cold breathing gas delivery system includes a breathing mask adapted to deliver a cooled breathing gas mixture and an injection device positioned near a distal end of the breathing mask. In an additional aspect, the injection device is configured release a fluid to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
An additional aspect of the invention provides a therapeutic treatment system having a delivery device adapted to deliver a cooled breathing gas mixture to a patient and an injection device positioned near a distal end of the delivery device, the injection device coupled to a source of liquid. The treatment system also includes a control system coupled to the delivery device and the injection device. Alternatively, the control system is adapted to control the injection device to release a fluid into the cooled breathing gas mixture to form a frozen mist of fine ice particles in the cooled breathing gas mixture.
In any of the aspects described herein, the cold breathing gas delivery system can further include a control system to actuate injection of fluid from the injection device into the cold breathing gas mixture. In addition, the dispensing of fluid should be timed to the flow of the breathing gas mixture into the patient during the inhalation portion of the patient's breathing cycle. The control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. One or more of a variety of sensors, which may comprise pressure sensors or flow sensors may be used. The control system and sensors can also record and monitor the patient's temperature using any known way of measuring a patient's temperature, such as an oral, urethral, skin, IR, or rectal probe. The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature.
Another aspect of the invention provides a method for treating a patient by delivering a cooled breathing gas mixture to a target tissue within the patient and injecting a fluid into the cooled breathing gas mixture at or near the target tissue to form a frozen mist of fine ice particles in the cooled breathing gas mixture. The target tissue may be a nasal airway of the patient, a lung of the patient, a mouth and a nasal airway of the patient, a throat of the patient a trachea of the patient or any combination of the above target tissue sites.
In any of the aspects described herein, there is also provided for injecting a drug into or mixing with the cooled breathing gas mixture. In one aspect, the drug is anesthetic drug. In another embodiment, the cooled breathing gas mixture is delivered directly to a target tissue of the patient and is combined with a therapeutic drug to directly treat the target tissue. The anesthetic or therapeutic drug can be added to the cooled breathing gas mixture and the mixture delivered to the sinuses of a patient. The drug may be selected to treat a condition of the patient using the sinuses. The condition may be migraine headache. The condition may be to induce therapeutic hypothermia through the sinuses.
In addition, drugs can also be added to the gas mixture, either at the breathing gas source, or with the use of a separate nebulizer or the like. Drugs such as bronchodilators, local (inhaled) vasodilators or any other medications that will increase the blood flow to the lungs for better heat transfer and prevent bronchoconstriction may also be added. Additionally or alternatively, drugs that encourage perspiration, peripheral vasodilators, and drugs that reduce or eliminate shivering can be delivered with the cooled breathing gas mixture. In addition, anesthetic drugs can be added to the breathing gas mixture or administered directly to the patient to reduce or eliminate pain in a target location that may be associated with inhaling the cooled breathing gas mixture may also be added. Anti-shivering agents and/or anti-thermoregulatory response agents may be administered to the patient to assist in achieving the desired degree of hypothermia. Alternatively or in addition, external warming, such as with a warm air blanket or electric blanket, may be applied to reduce shivering while internal hypothermia is maintained. Regional heating of selected portions of the patient's body may be used to control shivering and/or to modulate the body's thermoregulatory responses.
In another aspect of the invention, there is provided a method for treating a patient by forming a breathing gas mixture; cooling the breathing gas mixture; delivering the cooled breathing gas mixture to a target tissue within the patient; and injecting a fluid into the cooled breathing gas mixture at or near the target tissue to form a frozen mist of fine ice particles in the cooled breathing gas mixture. In this or any other aspect of the invention, the system may be adapted to provide for pressurizing the breathing gas mixture and the methods adapted to include one or more steps including the use of a pressurized breathing gas mixture. The pressure of the gas mixture can also be controlled. Pressurizing the gas mixture will further improve the mass flow rate, and hence the heat transfer rate. The gas mixture should be pressurized to levels known safe to the patient (for example 1.5-2 atmospheres). Alternatively, the pressure of the gas mixture can be pulsed, i.e. vary the pressure continuously from high to low, to help mix the breathing gas and improve the heat transfer rate.
In additional embodiment, the forming step also includes forming the breathing gas mixture from a gas mixture that includes oxygen and a gas with a high heat capacity. The breathing gas mixture may be formed from a gas mixture that includes oxygen and helium; a gas mixture that includes oxygen and carbon dioxide; a gas mixture that includes sulfur hexafluoride; or any combination of the above gas mixtures.
In another aspect, the breathing gas mixture may be air or a special gas mixture that includes oxygen (about 20% concentration or more) and a gas with a high heat capacity (Cp) for more effective heat exchange. The mixture can be regular or purified air, or air with a higher concentration of oxygen (from 20 to 100%). An alternative gas mixture could be oxygen and helium, such as HELIOX, which is 20% oxygen and 80% helium. Since the specific heat capacity for helium is much higher than the specific heat capacity for air, such a mixture could improve the heat flow rate and enable a more effective way of lowering the patient's temperature. In another embodiment, the gas mixture can include sulfur hexafluoride SF6, which is a dense, nontoxic gas that has a much higher specific heat capacity than air. Additionally, carbon dioxide (CO2) may be added to the gas mixture to help regulate the patient's respiration rate. Nitrous oxide can also be added to the breathing gas mixture 103. The gas mixtures listed above and other combinations of biocompatible gasses that are safe for inhalation may optionally be used.
In any of the aspects of the invention, injection into the cooled breathing gas mixture is provided with one or a combination of a fluid injector, a water injector, an air-water airbrush, a nozzle atomizer, a shaker bottle, a microfluidic device, a jet impact device, an ultrasonic droplet nozzle, a steam feeder, an ice shaver, an ultrasonic nebulizer nozzle, a swirl jet nozzle, an impaction pin nozzle, a colliding jets nozzle, a MEMS nozzle array mist generator, an electro spray nozzle, a heated capillary, an internal mixing nozzle, and an external mixing nozzle.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which.
Certain specific details are set forth in the following description and figures to provide an understanding of various embodiments of the invention. Certain well-known details, associated electronics and devices are not set forth in the following disclosure to avoid unnecessarily obscuring the various embodiments of the invention. Further, those of ordinary skill in the relevant art will understand that they can practice other embodiments of the invention without one or more of the details described below. Finally, while various processes are described with reference to steps and sequences in the following disclosure, the description is for providing a clear implementation of particular embodiments of the invention, and the steps and sequences of steps should not be taken as required to practice this invention.
The system described herein is used to create a fine mist of frozen ice particles in a cooled breathing gas mixture and deliver the cooled breathing gas mixture to a target tissue within a patient. The term “ice” as used herein should be understood to include any substance that has undergone a phase change from a vapor or liquid state to a solid state, such as by cooling. In one embodiment, the cooled breathing gas mixture and fine mist of frozen ice particles are delivered to the airways of a patient and ultimately the lungs to induce therapeutic hypothermia in the patient. The temperature of the blood in the lungs will decrease when exposed to the cold breathing gas mixture, which lowers the temperature of the heart tissue. The chilled blood can continue to flow to the coronary arteries where it will continue to lower the temperature of the tissue. In the case of myocardial infarction, the effect of this chilled blood flowing directly into the coronaries is especially beneficial. The blood can also flow from the left heart to the entire body to change the body temperature as desired. In the case of a stroke, a portion of the cooled blood will flow to the brain, cooling the tissue and reducing the metabolism and the oxygen consumption therein to reduce ischemic damage to the brain. Once therapeutic hypothermia has been achieved, the rate of heat transfer can be modulated by adjusting the quantity of ice particles delivered and the temperature of the breathing mixture can be adjusted to achieve and maintain the desired body temperature.
In another embodiment, the cooled breathing gas mixture is delivered directly to a target tissue of the patient, and can be combined with a therapeutic drug to directly treat the target tissue. For example, an anesthetic drug can be added to the cooled breathing gas mixture and the mixture can be delivered to the sinuses of a patient to treat migraine and also induce therapeutic hypothermia through the sinuses, for example.
The system described herein is designed to be portable and compact such that it can be easily administered to a patient by a variety of medical personnel, such as paramedics or EMT's in an ambulance, a medical team outside a hospital, an emergency room medical team or at any other location where this treatment is necessary. Advantages of the system include ease of operation and the ability to operate with minimal training. Thus treatment of the patient can begin much sooner after a heart attack, stroke or other event compared to other more invasive methods that can only be performed in an emergency room or in a cath lab. Rapid treatment for these conditions has been shown to improve patient outcomes by reducing ischemic damage and necrosis in the affected tissue.
The system described herein will generally include a delivery device and an injection device. The delivery device is sized for insertion into an airway of a patient, and can be an endotracheal tube, oropharyngeal airway (OPA), laryngeal mask airway (LMA), nasal cannula or nasopharyngeal airway (NPA), breathing mask, or other related medical devices. Although a typical breathing mask can be used, a slightly modified version that doesn't allow for a cold breathing gas mixture to contact the cheeks, lips, teeth, etc, of the patient is more desirable. For example, a modified breathing mask could include a short tube, such as 1-2″ in length, that extends into the mouth and is held in place with a gentle biting action or natural closing tension of the jaw or lips. The type of delivery device used may depend on the personal intended to use the system. For example, only highly trained medical personnel, such as medical doctors and physician assistants, may be qualified to intubate a patient with an endotracheal tube. So a system utilizing an endotracheal tube type delivery device may be limited to a hospital setting. However, a system designed for use by an EMT or ambulance paramedic may use a breathing mask or nasal cannula as the delivery device. In general, many types of delivery devices may be used with the system to provide therapeutic hypothermia to a patient and/or treat a target tissue of the patient depending on the qualifications and location of those administering treatment.
The system can utilize various methods to create a frozen mist of fine ice particles in the patient. This can include several types of fluid injectors, ice scrapers, pressure nozzles, and the like to disperse a fine mist of fluid into a cold breathing gas mixture carried by the delivery device. When the fine mist of fluid comes into contact with the cold breathing gas mixture, a fine mist of frozen ice particles are formed and carried into the patient.
The system can additionally include a fluid source, a breathing gas mixture source, a control system, temperature and pressure sensors, pumps, and a mechanical respirator/ventilator for use with the delivery device and injection device. These system components can work together to control delivery of the cold breathing gas mixture and fine mist of frozen ice particles to the patient.
The amount of ice particles added to the breathing gas mixture is preferably in the range of 0 to 5 liters per hour (measured as the volume of fluid injected to produce the frozen mist.) A flow rate of ice particles in the range of 0.25 to 1 liters per hour is currently thought to be sufficient for rapidly achieving hypothermia in an adult human patient. Due to the latent heat of fusion (the heat required to effect a phase change from liquid water to ice), the incoming breathing gas may need to be cooled to a temperature significantly below the freezing point to achieve effective freezing of the fluid droplets. Optionally, the fluid injection can be timed with the pulsatile flow of breathing gas.
The frozen mist can carried into the patient's lungs by the breathing gas. The ice particles can melt within the patient's lungs providing a high rate of heat transfer for cooling the lungs and the blood that flows through them. Because of the high heat transfer rate provided by the melting of ice particles, an extremely low temperature will not be needed for effective cooling of the patient, thereby mitigating the risk of freezing damage to the patient's lungs. After the need for protective hypothermia has passed, the system may be used for rewarming the patient to normothermia. For example, the system may be used to inject water into the patient at a temperature higher than the body temperature but below the threshold of damage or discomfort to the patient, preferably at 37-52° C.
The amount of fluid that forms in the lungs from the melting of the ice particles can be easily tolerated by the patient. An adult human with good lung function can readily clear 1 liter per hour of fluid from the lungs through normal processes. Thus, a flow rate of ice particles in the range of 0.25 to 1 liters per hour will be readily tolerated for an extended period of several hours. Higher flow rate of ice particles, up to 5 liters per hour, can be tolerated for shorter periods. If desired, positive pressure ventilation may be used to help drive the fluid from the lung passages into the surrounding tissue and from there into the bloodstream. In addition, diuretics or other medications to treat pulmonary edema may be administered to the patient to help eliminate excess water if needed.
The invention will now be described with respect to the drawings.
The gas mixture 103 can be cooled using any known method of cooling. These cooling methods can be incorporated into the gas source 108 or can be separate system components. For example, heat exchangers, electric coolers, pressurization, refrigeration and the like can be utilized in system 100 to cool the gas. The heat exchanger can utilize a refrigeration cycle, a reversible heat pump, a thermoelectric heater/cooler, dry ice, liquid nitrogen or other cryogen, or other known heater/cooler to achieve the desired temperature. Similarly, gas source 108 can be submerged in a chilled liquid bath, such as an antifreeze/water bath or liquid nitrogen bath. The gas mixture 103 can be chilled to very cold temperatures, such as temperatures as low as −100° C., for example. Due to the low temperatures of gas mixture that can flow through delivery device 102, it may be necessary to insulate delivery device 102. This can be accomplished by any insulation methods as known in the art, such as fiberglass, foam, or by using evacuated doubled walled chambers.
The gas mixture 103 may be air or a special gas mixture that includes oxygen (about 20% concentration or more) and a gas with a high heat capacity (Cp) for more effective heat exchange. The mixture can be regular or purified air, or air with a higher concentration of oxygen (from 20 to 100%). An alternative gas mixture could be oxygen and helium, such as HELIOX, which is 20% oxygen and 80% helium. Since the specific heat capacity for helium is much higher than the specific heat capacity for air, such a mixture could improve the heat flow rate and enable a more effective way of lowering the patient's temperature. In another embodiment, the gas mixture can include sulfur hexafluoride SF6, which is a dense, nontoxic gas that has a much higher specific heat capacity than air. Additionally, carbon dioxide (CO2) may be added to the gas mixture to help regulate the patient's respiration rate. Nitrous oxide can also be added to the breathing gas mixture 103. The gas mixtures listed above and other combinations of biocompatible gasses that are safe for inhalation may optionally be used.
The pressure of the gas mixture can also be controlled. Pressurizing the gas mixture will further improve the mass flow rate, and hence the heat transfer rate. The gas mixture should be pressurized to levels known safe to the patient (for example 1.5-2 atmospheres). Alternatively, the pressure of the gas mixture can be pulsed, i.e. vary the pressure continuously from high to low, to help mix the breathing gas and improve the heat transfer rate.
Drugs can also be added to the gas mixture 103, either at the breathing gas source 108, or with the use of a separate nebulizer or the like. Drugs such as bronchodilators, local (inhaled) vasodilators or any other medications that will increase the blood flow to the lungs for better heat transfer and prevent bronchoconstriction due to the cold breathing mixture. Furthermore, drugs that encourage perspiration, peripheral vasodilators, and drugs that reduce or eliminate shivering can be delivered with the cooled breathing gas mixture. In addition, anesthetic drugs can be added to the breathing gas mixture or administered directly to the patient to reduce or eliminate pain in a target location that may be associated with inhaling the cooled breathing gas mixture. Anti-shivering agents and/or anti-thermoregulatory response agents may be administered to the patient to assist in achieving the desired degree of hypothermia. Alternatively or in addition, external warming, such as with a warm air blanket or electric blanket, may be applied to reduce shivering while internal hypothermia is maintained. Regional heating of selected portions of the patient's body may be used to control shivering and/or to “trick” the body's thermoregulatory responses.
System 100 further comprises injection device 104 configured to inject a fluid into the cold breathing gas mixture 103 to form a frozen mist of fine ice particles 101 in the cooled breathing gas mixture. Injection device 104 is preferably positioned at or near the distal end or exit port 107 of delivery device 102. Positioning the injection device close to the exit port of the delivery device maximizes the ability of system 100 to deliver a frozen mist of ice particles directly to the target tissue of the patient while maximizing the percentage of particles that exit the device and make contact with target tissue. In contrast, introducing the liquid to the breathing gas mixture at any point further upstream of the exit port could lead to ice particles adhering to the inner walls of the delivery device and causing system congestion or clogging, reducing the number of ice particles ultimately reaching the target tissue of the patient for therapeutic treatment or causing complete system failure. Even if the frozen mist of fine ice particles is formed as close to the target tissue of the patient as possible, there still may be some ice formation within the system. Thus, it may be necessary to clear ice from within the system. This can be accomplished by a variety of mechanical ways, including scrapers, wipers, brushes, by vibration at low frequencies, sonic frequencies, ultrasonic frequencies, or through the application of heat, either by heating the delivery device directly or periodically allowing a warm breathing gas mixture to flow into the device to melt any accumulations.
Injection device 104 can be coupled to fluid source 110 by fluid line 105. The fluid source will preferably contain normal saline solution (0.9% NaCl) or any other desired solution, so that it will be isotonic with the patient's blood. Alternatively plain water, e.g. distilled water, may be used. If plain water is used, NaCl may be added to the breathing mixture, or may be administered to the patient orally or via another route to maintain an isotonic concentration. The fluid source may be held at a higher pressure than the breathing gas mixture to aid in mist formation. It may be desirable to use liquids other than water or saline to form the frozen mist of fine ice particles. Thus, the terms “frozen mist of fine ice particles” as used herein should not be limited to frozen water or saline, but rather, should be understood to include any substance that undergoes a phase change from a vapor or liquid to a solid state.
In
Injection device 104 can comprise a variety of devices adapted inject fluid into the cooled breathing gas mixture. For example, injection device 104 can be a water injector, a spray bottle/nozzle atomizer, a shaker bottle, a microfluidic injector, a jet impact nozzle, an ultrasonic nozzle, a steam feeder, an ultrasonic nebulizer, a swirl jet nozzle, an impaction pin nozzle, a colliding jets nozzle, a MEMS nozzle array mist generator, an electro spray nozzle, a heated capillary, an internal mixing nozzle, an external mixing nozzle, or other appropriate injectors as known in the art. Instead of using an injection device, ice particles or fluid/mist can also be introduced into the gas mixture with an air-water airbrush (i.e., a venturi) or an ice shaver. Many of these embodiments of injection devices will be discussed in further detail below and in the drawings.
System 100 can further include a control system 106 to actuate injection of fluid from the injection device into the cold breathing gas mixture. Preferably, the dispensing of fluid should be timed to the flow of the breathing gas mixture into the patient during the inhalation portion of the patient's breathing cycle. To achieve this result, the control system can receive a sensor input that indicates when inhalation is about to occur, when it is occurring, and/or when inhalation is completing. This can be achieved by a variety of sensors 112, which may comprise pressure sensors or flow sensors. The control system and sensors 112 can also record and monitor the patient's temperature using any known way of measuring a patient's temperature, such as an oral, urethral, skin, IR, or rectal probe. The control system can use the measured temperatures and pressure/flow sensors as feedback to adjust the temperature of the breathing gas mixture, the temperature of the fluid, the rate and volume of breathing gas mixture delivered to the patient, and the volume of fluid injected into the breathing gas mixture by the injection device according to the desired patient temperature.
Yet another embodiment of system 100 is shown in
A first embodiment of an injection device suitable for use with system 100 is illustrated in
Other injection device embodiments are shown in
In
In
In the embodiment illustrated in
Additionally, ultrasonic nozzle 204g in
System 300 and 300′ as illustrated in
Similarly, system 300′ in
Yet another method for forming a frozen mist of fine ice particles is illustrated in
As for additional details pertinent to the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US09/66380 | 12/2/2009 | WO | 00 | 3/12/2012 |
| Number | Date | Country | |
|---|---|---|---|
| 61119305 | Dec 2008 | US |
