Patent Application
20110094509
This disclosure relates generally to a method and arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas.
In order to perform surgery the patient must be anesthetized. This incorporates hypnosis and pain prevention and is achieved with anesthetizing drugs. The most common drugs used for the purpose are inhalation anesthetics. These are either gases (N2O) or volatile liquids (inhalation agents). Before delivery to patient breathing the inhalation agents are converted to gaseous form in anesthesia vaporizers. The anesthesia delivery systems may comprise multitude of vaporizers for different agents, or the vaporizer is easily exchangeable to another. The delivery systems are designed to allow delivery of one agent at a time, but for various reasons a need to change the agent from one to another may emerge. Such reasons are e.g. better acceptance of one agent when patient is still awake during anesthesia induction and faster recovery from anesthesia or less post-anesthesia nausea of another.
Once vaporized, the anesthetic agent is delivered to anesthesia breathing circuit for delivery to patient. The anesthesia breathing system allows re-breathing of the patient exhaled breathing gas. This re-breathing is used to preserve patient expired expensive and environmental-hostile anesthesia agent vapors to reduce the agent consumption.
The re-breathing circuit comprises of inspiration- and expiration limbs, Y-piece, CO2 absorber to refresh the exhalation gas for re-breathing, and ventilator tubing. Other breathing gas volumes are the ventilator gas isolation system and patient lungs. The total gas volume of the system may be up to 7 liters.
The breathing gas meets the blood circulation in the lungs. There the agent dissolves into the blood that transports the agent to further body. From the blood the agent dissolves further to various tissues including the site of anesthetic effect in brains. Each of the agents has their own threshold brain concentration to be achieved in order to make the patient anesthetized. The required concentration is also patient specific, but for each agent a mean alveolar concentration (MAC) has been determined. This describes the concentration of the vapor measured in percentage at 101.3 kPa ambient pressure preventing a patient movement under a surgical stimuli of a skin incision in 50% of patients. To reach a higher confidence level for a proper anesthesia the patients are usually given the agent corresponding 1.2-1.3 MAC. Concentration corresponding to 1 MAC is 2.1% for sevoflurane, 6.0% for desflurane, 1.1% for isoflurane, 0.76% for halothane, 1.7% for enflurane, and 101% for nitrous oxide (N2O). These values are for patients of 40 year old. The values are decreasing with the age.
MAC may be determined also for other indications, MAC-Awake is an example of this determining the concentration suppressing a response on commands in 50% of patients. For narcotics the MAC-Awake is of the order of ⅓ of the MAC.
At steady state anesthesia the breathing circuit volumes and the patient tissues are filled to this required concentration. Patient anesthesia status is measured as end-tidal concentration of the agent determined as the gas concentration exhaled by the patient at end of expiration. At steady state this equals the effect site concentration and corresponds with patient depth of anesthesia. Solubility of the agent to the body tissues and the required concentration determines the amount of the agent present in the system and patient tissues. Concentration in large tissue volumes and the amount of drug in the patient increases slowly before the steady state is achieved.
As agent induction, agent clearance from the body occurs as well through the lungs: When the breathing gas ventilating the lungs have the agent concentration low compared to alveols of the lungs, the agent concentration of the alveol will decrease. Higher anesthetic agent vapor pressure of blood drives for diffusion of the agent from blood to alveoli decreasing the blood vapor pressure. Similarly the reduced blood vapor pressure allows clearance from tissues having higher vapor pressure. Depending on agent, its solubility to tissues, and size of the tissues determines the clearance of the body from the anesthesia agents.
/The effect of the anesthesia agents is linear and additive. Thus, if the subject gets properly anesthetized with the narcotic effect value such as 1 MAC, this may be achieved e.g. with delivery of 0.5 MAC of sevoflurane (=0.5×2.1%=1.05%) and 0.5 MAC of N2O (=0.5×101%=50.5%). Normally the agent mixtures occur when delivering N2O as fresh gas and completing its narcotic effect with some volatile agent. Due to the additive nature of the anesthetizing effect of the different agents, if changing the concentration of one agent, in order to preserve the total effect, changing the other agent as well must compensate the change.
The patient breathing gas is a mixture of oxygen (O2), balance gas N2O or N2, and the volatile agent. Patient concentration for O2 varies normally between 25-35 volume %, but may sometimes increase over 80%. The patient agent concentration depends on the MAC value and varies from 1 to 10 volume %. The rest of the mixture is balance gas. The balance gas concentration depends on the O2 concentration required. If that needs to be changed for any therapeutic reasons and N2O, is used as a balance gas, the anesthetizing effect (MAC reading) of the N2O becomes changed as well. Therefore in order to maintain anesthesia, delivery of volatile anesthetics must be adjusted as well.
The additive behavior of the agents need to be taken into consideration especially if changing from one volatile agent to another during anesthesia: Before switchover the old agent corresponds to one MAC maintaining proper anesthesia, and after switchover the new agent does the same. During the switchover the sum of the old and new agent should sum up to the desired MAC. This is difficult in practice since the clearance of the old agent depends on various aspects, as the patient size, agent, and the agent saturation of the tissues, and wash-in of the new agent should be synchronized with the clearance of the old concentration that is measured as the patient exhalation gas concentration.
Inhalation anesthesia delivery control systems may enclose closed loop control of vaporizer in order to match the measured patient end-tidal anesthesia agent concentration to match with user given target. Such system helps the anesthesiologist to reach and maintain determined anesthesia level throughout various changes during anesthesia. Such control systems do however not solve the whole problem when the anesthesia is delivered as a sum of various anesthetizing agents: The clinician needs still titrate gradually the end-tidal target of the delivered volatile agent as a response of clearance of the previous agent or as a response to N2O concentration changes
The above-mentioned shortcomings, disadvantages and problems are addressed herein which will be understood by reading and understanding the following specification.
In an embodiment, a method for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas includes setting a target value for a desired narcotic effect of narcotic agents and measuring a breathing gas concentration of each narcotic agent of the breathing gas. The method for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas also includes converting measured breathing gas concentration of each narcotic agent to a narcotic effect value of the breathing gas and calculating a total narcotic effect value of the mixture of the at least two narcotic agents. The method for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas further includes comparing the total narcotic effect value with the target value and determining whether or not to change the breathing gas concentration to meet the target value.
In another embodiment, an arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas includes a gas delivery unit for supplying a breathing gas including a mixture of at least two narcotic agents for a respiration, the gas delivery unit comprising at least one narcotic agent supply. The arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas also includes a gas analyzer for measuring a breathing gas concentration of each narcotic agent of the breathing gas and a user interface for setting a target value, for a desired narcotic effect of narcotic agents. The arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas further includes a controller for converting the measured concentration of each narcotic agent to a narcotic effect value of the breathing gas, for calculating a total narcotic effect value of the mixture of the at least two narcotic agents, for comparing the total narcotic effect value with the target value and for determining whether or not to change the breathing gas concentration to meet the target value.
In yet another embodiment an arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas includes a ventilator configured to control respiratory movements and a gas delivery unit for supplying a breathing gas including a mixture of at least two narcotic agents for a respiration, the gas delivery unit comprising at least one narcotic agent supply. The arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas also includes a breathing circuit for conducting an expiration gas flow to the ventilator and for conducting the fresh gas flow from the gas delivery unit for the respiration and for conducting the ventilator gas flow for the inspiration. The arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas further includes a gas analyzer for measuring a breathing gas concentration of each narcotic agent of the breathing gas and a user interface for setting a target value for a desired narcotic effect of narcotic agents. The arrangement for controlling a narcotic effect value of a mixture of at least two narcotic agents of a breathing gas also includes a controller for converting the measured concentration of each narcotic agent to a narcotic effect value of the breathing gas, for calculating a total narcotic effect value of the mixture of the at least two narcotic agents, for comparing the total narcotic effect value with the target value and for determining whether or not to change the breathing gas concentration to meet the target value.
Various other features, objects, and advantages of the invention will be made apparent to those skilled in art from the accompanying drawings and detailed description thereof.
Specific embodiments are explained in the following detailed description making a reference to accompanying drawings. These detailed embodiments can naturally be modified and should not limit the scope of the invention as set forth in the claims.
In
When ventilating the subject, the expiration valve 9 is closed and the flow control valve 7 is opened for the inspiration flow. This flow fills the bottle 14 making the bellows 15 to push down pushing the gas within the bellows further towards the subject 4. During the expiration the flow control valve 7 is closed and the expiration valve 9 is opened to control the expiration flow and pressure. The gas pressurized in the bottle 14 is released allowing the gas from lungs to fill the bellows 15 up. When the bellows 15 is filled, it hits the top of the bottle 14, and the further gas flow into the system increases the pressure within the bellows 15. When this pressure exceeds the bottle pressure, the scavenging valve 11 will open allowing the further gas flow to scavenging valve 11.
The ventilator 1 is operably connected to the breathing circuit 2 such as a re-breathing circuit by means of a ventilator tube 17 for both inspired and expired gas flows. The breathing circuit 2 comprises an inspiration tube 18 for inspired gas, an expiration tube 19 for expired gas, a CO2 remover 20 such as CO2 absorber to remove or absorb carbon dioxide from the exhaled gas coming from the subject 4, a first one way valve 21 to allow an inspiration through the inspiration tube 18, a second one way valve 22 to allow an expiration through the expiration tube 19, a branching unit 23 such as a Y-piece having at least three limbs, one of them being an inhalation limb 24 for inspired gas, a second one being an expiration limb 25 for expired gas, a third one being a combined inspiration and expiration limb 26 for both inspired and expired gases. The inhalation limb 24 is connectable to the inspiration tube 18 and the expiration limb 25 is connectable to the expiration tube 19. The combined inspiration and expiration limb 26 of the branching unit 23 may be connectable by means of a patient tube 27 to the endotracheal tube 28 allowing the gas exchange with airways of the subject 4.
The inspiration gas flows from the reciprocating unit 6 through the ventilator tube 17, the CO2 remover 20 and the inspiration tube 18 of the breathing circuit 2 to the branching unit 23 and further through the patient tube 27 and the endotracheal tube 28 to the lungs of the subject 4. The second one-way valve 22 on the expiratory tube 19 guides the gas flow direction to the inspiration tube 18 by closing the flow from the ventilator tube 17 through the expiration tube 19. Increasing the gas volume within the lungs increases the lung pressure due to the lung compliance. Once the inspiration stops and the expiration begins the expiration valve 9 opens relieving the bottle 14 pressure, the lung compliance pushes the alveolar gas through the endotracheal tube 28 and the patient tube 27 to the branching unit 23 and further through the expiration tube 19 and the ventilator tube 17 to fill the bellows 15.
The gas delivery unit 3 for delivering a fresh gas is operably connected to the breathing circuit 2. The gas delivery unit 3 is used to form the subject breathing gas. One or more gas supplies 5, 30, 31 is connected to the gas delivery unit 3. The gas supplies 30 and 31 are just as the gas supply 5 operably connected to respective filterings 52, 53 and pressure regulations 54, 55. The gas supply 5 is for the air as described above including a balance gas such as nitrogen, the gas supply 30 is for oxygen and the gas supply 31 is for an alternate balance gas, which is typically nitrous oxide. Nitrous oxide is also a narcotic agent. The gas delivery unit comprises a selector valve 32 to select either the gas supply 31 for nitrous oxide or the gas supply 5 for air, a flow regulating valve 33 for adjusting a balance gas flow, a flow regulating valve 34 for adjusting oxygen flow and an at least one narcotic agent supply 37 such as a vaporizer for supplying a narcotic agent such as an anesthetic agent to anesthetize the subject 4. The gas delivery unit 3 also comprises flow sensors 35, 36 for measuring the individual fresh gas flows coming from flow regulating valves 33, 34 and which flows may be added into the breathing circuit 2 for respiration. The flow sensor 35 downstream the flow regulating valve 33 is adapted to measure the balance gas flow as a fresh gas, the flow sensor 36 downstream the flow regulating valve 34 may be adapted to measure oxygen flow as a fresh gas.
Using the flow sensor measurement information obtained from the flow sensors 35, 36 the controller 40 regulates the flow regulating valves 33 and 34 to deliver the required gas flows. After flow measurements the individual gas flows are usually merged to a gas mixture at a connection 29. The mixture may then be further guided to the narcotic agent supply 37 for adding the narcotic inhalation agent into the mixture as shown in
The gas analyzer 39 is enabled to measure the breathing gas or exhalation gas concentrations such as the end-tidal concentrations of all narcotic agents contributing to the narcotic effect value of the subject. This includes typically ability to measure N2O concentration and mixture of two narcotic agents. The gas analyzer 39 may also identify narcotic agents in case they are not known. The gas analyzer 39 of
The controller 40 for controlling the narcotic agent value includes a processing unit (not shown in the Figure) to receive the information indicative of the measured breathing gas concentration of the narcotic agent and which narcotic agent is from one of the narcotic agent supply 37 and the gas supply 31. Through the user interface 42 along a signal line 100 the user may set to the controller 40 a target value for a desired narcotic effect of narcotic agents. The desired narcotic effect may be determined in terms of the concentration of the vapor measured in percentage at 101.3 kPa ambient pressure preventing a patient movement under a surgical stimuli of a skin incision in 50% of patients which is often called as a mean alveolar concentration of inhaled narcotic agents (MAC) or the desired narcotic effect may be determined in terms of a concentration suppressing a response on commands in 50% of subjects such as MAC-awake. It is understood the desired narcotic effect value as well as the converted narcotic effect value may be a compensated value in which case some specific matter or matters affecting to the narcosis has been taken into account and possibly compensated. Such specific matter is for example a subject age. Besides the subject age compensated value such as an age MAC also a barometric pressure belongs to compensated values. Also there may be a reason for other compensated values. The barometric pressure can be measured with a pressure sensor (not shown in the figures) or configured using the user interface 42. In this embodiment the user interface 42 is used to inform the controller 40 about the subject age as well.
To take into consideration all narcotic agents of the breathing gas the controller 40 is able to collect from the gas analyzer 39 the information indicative of measured breathing gas concentration of each narcotic agent which can be converted to the narcotic effect value. All narcotic agents should be taken into consideration. These narcotic effect values of each narcotic agent are after a calculation summed up and compared by the controller 40 with the target value received from the user interface 42 and determined whether or not to change the breathing gas concentration. In case the target value deviates from the narcotic effect value converted from measurement results of the narcotic agents the actuator 38 is under the control of the controller 40 adjusting the narcotic agent flow from the narcotic agent supply 37 in order to reduce a deviation. When using N2O as the balance gas, the subject oxygenation demand determines the narcotic effect available from the N2O. Therefore the flow regulating valve 33 can usually not be used in practice for the narcotic control.
The controller 40 is connected through a signal line 101 to the selector valve 32 of the fresh gas delivery unit 3, which signal line 101 is adapted to carry a signal from the controller 40 to the selector valve 32. Also the controller 40 is connected through a signal line 102 to the flow regulating valve 33 of the fresh gas delivery unit, which signal line 102 is adapted to carry a signal from the controller 40 to the flow regulating valve 33. Further the controller 40 is connected through a signal line 103 to the flow sensor 35 of the fresh gas delivery unit 3, which signal line 103 is adapted to carry a signal from this flow sensor 35 to the controller 40. Also the controller 40 is connected through a signal line 104 to the flow regulating valve 34 of the gas delivery unit 3, which signal line 104 is adapted to carry a signal from the controller 40 to the flow regulating valve 34. This controller 40 is also connected through a signal line 105 to the flow sensor 36, which signal line 105 is adapted to carry a signal from the flow sensor 36 to the controller 40. The controller 40 is also connected through a signal line 106 to the gas analyzer 39, which signal line is adapted to carry a signal indicative of a measured alveolar concentration of each narcotic agent from the gas analyzer 39 to the controller 40. The signal line 107 is needed in inhalation anesthesia to carry a signal between the actuator 38 for at least one narcotic agent supply 37 and the controller 40 to adjust the narcotic agent.
At step 61 the target value for the desired narcotic effect is set. The user may do this by means of the user interface 42 and he/she does not necessarily need to consider concentrations of each narcotic agent of the breathing gas, but it is enough to give the target value for desired narcotic effect and select the narcotic agent used and let the controller 40 to take care of the rest. The desired narcotic effect value may be also a compensated value in which case some specific matter or matters affecting to the narcosis has been taken into account and possibly compensated.
In case narcotic agents used in the breathing gas are not known, their identification should be done by means of the gas analyzer 39 at step 62, which is thus optional, but which is in any case advantageous to avoid wrong identifications. This identification information can also be sent via signal line 106 to the controller 40.
Breathing gas concentrations of each narcotic agent at step 63 are measured by the gas analyzer 39. The concentration measurement includes also the nitrous oxide concentration as one possible narcotic agent present in the breathing gas. Typically the concentration of the narcotic agent present in the exhalation gas or especially the end tidal concentration is measured during anesthesia.
The measured breathing gas concentration of each narcotic agent received by the controller 40 is converted to the narcotic effect value at step 64. The controller 40 is also able to do this conversion. The converted narcotic effect value may be also a compensated value in which case some specific matter or matters affecting to the narcosis has been taken into account and possibly compensated. Each narcotic agent has concentration giving determined narcotic effect in 50% of patients. This concentration is assigned as a reference concentration value in calculating the narcotic effect value such as the mean alveolar concentration (MAC), MACAGE or MACAWAKE. These reference concentration values are often determined at sea-level conditions. At higher altitudes these concentration values are increasing in ratio of barometric pressure decrease. Thus, the narcotic effect of given anesthetic agent at given barometric pressure is calculated as:
where N is the narcotic effect, C is the alveolar concentration, Cref is reference concentration value providing desired narcotic effect in 50% of patients, Psealevel is the ambient pressure at sea level (101.3 hPa) and Pamb is the prevailing ambient pressure at the site of performing the anesthesia. Thus, as an example, having sevoflurane anesthesia at barometric pressure of 95 hPa and measuring patient alveolar concentration of 2.5% represents
At step 65 when the mixture of at least two narcotic agents have been used a total narcotic effect value of all narcotic agents is calculated by the controller 40. The total narcotic effect value may be a sum of the narcotic effect values of the mixture. The narcotic effect values of the narcotic agents are linear and additive allowing a simple calculation process. So if the narcotic effect value is 0.6 MAC for one agent and 0.5 MAC for another agent then their sum is 1.1 MAC.
The sum of the narcotic effect values is compared at step 66 with the target value set at step 61. Again the controller 40 is able to do this. Based on the comparison the controller 40 can at step 67 determine whether or not to change the breathing gas concentration and may also determine the action needed in order to make the target value and the narcotic effect value to match whereupon the difference between the target value and the narcotic effect value is reduced. If the sum of the narcotic effect value is below the target value, the controller 40 may change or increase at least one narcotic agent's concentration in the breathing gas. This may happen by allowing the actuator 38 to deliver more narcotic agent of the narcotic agent supply 37. On the other hand if the total the narcotic effect value is over the target value the actuator 38 may allow to deliver less narcotic agent from the narcotic agent supply 37. Thus possible actions are increasing, decreasing, or maintaining the delivery of the narcotic agent. The total narcotic effect value is allowed deviate from the target value less than 30%, more specifically less than 20% or, even more specifically less than 10% without changing the narcotic agent concentration in the breathing gas. This deviation can be allowed to both directions. Using this method or arrangement of the embodiment the controller 40 automatically responds in changing the delivery of the narcotic agent when the concentrations of the other narcotic agents are changing. E.g. when changing from one agent to another during anesthesia involves gradual increment of the new narcotic agent concentration corresponding to the clearance of the old narcotic agent from the body.
This embodiment provides ease of use during changes in breathing gas O2 concentration and in changing between different inhalation narcotic agents during the anesthesia. The embodiment also provides a patient safety in preventing accidental over- and under-delivery of the narcotic agent during these transient phases.
The written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to make and use the invention. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 09174294.0 | Oct 2009 | EP | regional |
