Method for drug delivery in association with medical or surgical procedures

• US 20050010165A1
• Filed: 08/03/2004
• Published: 01/13/2005
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: Scott Laboratories
• Original Assignee: Scott Laboratories
• Inventors: Hickle, Randall S.
• Granted Patent: US 7,247,154 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/162 Testing reaction times
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/0084 self-reinflatable by elasticity, e.g. resuscitation squeeze bags
• CPC Class Codes: A61M 16/009 Removing used or expired gases or anaesthetic vapours filtering, sterilising or disinfecting the exhaust air in drainage systems A61M1/784; bacterial filters in the expiratory path A61M16/1065
• CPC Class Codes: A61M 16/0093 by adsorption, absorption or filtration
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/1015 using a gas flush valve, e.g. oxygen flush valve
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/43 : Composition of exhalation
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 428/24355 : Continuous and nonuniform or irregular surface on layer or component [e.g., roofing, etc.]

Abstract

Disclosed are methods for facilitating medical and/or procedures that are performed without “general anesthesia,” which is also described in the specification as the state of patient “unconsciousness” resulting from a drug administered by an anesthetist or anesthesiologist. The methods safely and effectively provide and maintain drug infusions that do not push the patient into unconsciousness and/or general anesthesia. Methods according to certain embodiments of the invention include the use of parameters and/or values that correlate to drug delivery during a procedure, and a patient health monitor to measure and send signals regarding a patient health condition to a processor.

Claims

1-96. -96. (cancelled).

97. A method for sedating a patient in connection with the patient undergoing one or more medical and/or surgical procedures without general anesthesia, said method comprising:

connecting to a patient a drug delivery device capable of controllable drug delivery to the patient during said procedure, said drug delivery device being coupled to a controller which controls the delivery of drugs to the patient;

attaching at least one patient health monitor device to a patient, said health monitor device generating a signal reflecting at least one monitored physiological condition of the patient during said procedure;

delivering one or more drugs to the patient during said procedure with said drug delivery device;

said drug being delivered at a desired supply rate;

sending said signal from said health monitor device to said controller during said procedure, said signal communicating a present value reflecting said monitored physiological condition of the patient;

accessing parameters for said monitored physiological condition, said parameters indicating values for said measurements of said monitored physiological condition where said values correlate to levels of desired sedation during said procedure;

comparing said measurements reflected in said received signal with said parameters; and

modifying said desired supply rate of the drugs as necessary in response to said comparing in order to maintain said patient safely within said levels of desired sedation during said procedure.

98. The method as recited in claim 97, wherein said patient health monitor is selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer and a patient consciousness monitor.

99. The method as recited in claim 97, wherein said values define a preset normal range of said measurements for a patient undergoing said procedure, and wherein said changing of said drug delivery rate comprises decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

100. The method as recited in claim 99, wherein said preset normal range is identified by at least one threshold for said measurements.

101. The method as recited in claim 100, wherein said values define at least two thresholds concerning said physiological condition, and wherein said thresholds designate different levels of concern for said patient when measurements are outside of said preset normal range.

102. The method as recited in claim 97, wherein said values define measurements of said monitored physiological condition that evidence the onset of potentially undesirable patient conditions during said procedure.

103. The method as recited in claim 102, wherein said values further define measurements of said monitored physiological condition that evidence the onset of potentially unsafe patient conditions during said procedure.

104. The method as recited in claim 97, wherein the drug is propofol.

105. The method as recited in claim 97, wherein the drug is selected from the group consisting of remifentanil and fentanyl.

106. The method as recited in claim 97, wherein the delivering of the drugs step is accomplished by target-controlled infusion.

107. The method as recited in claim 97, wherein said patient health monitor device is a brain activity monitor and said modifying of said supply rate of drug is in response to a concentration of drug in the patient.

108. The method as recited in claim 97, wherein said patient health monitor device is a pulse oximeter and the modifying of said supply rate of the drug is in response to changes in a monitored blood oxygen level of the patient.

109. The method as recited in claim 97, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

110. The method as recited in claim 97, wherein said monitor device is a blood pressure monitor.

111. The method as recited in claim 97, further comprising creating a record detailing delivering of said drug during said one or more procedures.

112. The method as recited in claim 111, wherein said record further details information regarding said monitored physiological condition.

113. The method as recited in claim 97, wherein said delivering of said drugs is performed by a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

114. The method as recited in claim 97, further comprising manually altering the delivery of drug.

115. The method as recited in claim 114, wherein said manual altering comprises increasing a current rate of drug delivery to the patient.

116. The method as recited in claim 97, further comprising generating a signal reflecting a state of at least one operating condition of said drug delivery device or said patient health monitor device, said signal being received by said controller, and said controller initiating alarms if said operating condition is unsatisfactory.

117. The method as recited in claim 116, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

118. The method as recited in claim 97, wherein said monitored physiological condition is the patient'"'"'s level of responsiveness.

119. A method of providing sedation without general anesthesia to a non-intubated patient in need thereof during a medical and/or surgical procedure with an electronic drug delivery apparatus, said method comprising:

coupling said drug delivery apparatus to said patient;

delivering a sedative drug to said patient with said a controllable drug delivery device, said delivery being at a drug delivery rate sufficient for said patient to approach but not enter general anesthesia during said procedure;

monitoring at least one physiological condition of the patient;

electronically comparing the physiological condition of said patient with information reflecting a safe physiological condition for patients during said procedure, and

electronically controlling the drug delivery rate at which said controllable drug delivery device is delivering said drug during said procedure to maintain a safe physiological condition.

120. The method as recited in claim 119, wherein said changing of said drug delivery rate is accomplished by applying an algorithm conforming to target-controlled infusion rates for the drug delivered to the patient during said medical procedure.

121. The method as recited in claim 119, further comprising detecting failure of said comparison step and providing a signal in the event of a failure.

122. The method as recited in claim 119, wherein said monitored physiological condition comprises functioning of the patient'"'"'s airway.

123. The method as recited in claim 119, wherein said monitored physiological condition is the patient'"'"'s level of consciousness.

124. The method as recited in claim 119, wherein a record is made of drug infusion that occurred during said procedure.

125. The method as recited in claim 119, wherein said drug is propofol.

126. The method as recited in claim 119, wherein said monitored physiological condition is oxygenation, and said method further comprising automatically increasing a supply of supplemental oxygen to the patient in the event a detected oxygen level of the patient diminishes.

127. The method as recited in claim 119, wherein said delivering of drugs is accomplished through a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

128. The method as recited in claim 119, wherein said physiological condition is selected from the group consisting of a brain activity, heart rate, blood saturation, expired carbon dioxide, ventilation, and patient consciousness level.

129. The method as recited in claim 119, wherein said monitoring of said physiological conditions are performed with patient health monitors selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer and a patient consciousness monitor.

130. The method as recited in claim 119, wherein said information defines a preset normal range of said measurements for a patient undergoing said procedure, and wherein said controlling of said drug delivery rate comprises decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

131. The method as recited in claim 130, wherein said preset normal range is identified by at least one threshold for said measurements.

132. The method as recited in claim 130, wherein said information defines at least two thresholds concerning said physiological condition, and wherein said thresholds designate different levels of concern for said patient when measurements are outside of said preset normal range.

133. The method as recited in claim 119, wherein said information defines measurements of said monitored physiological condition that evidence the onset of potentially undesirable patient conditions during said procedure.

134. The method as recited in claim 119, wherein the drug is remifentanil.

135. The method as recited in claim 119, wherein said monitoring is performed by a brain activity monitor and said modifying of said supply rate of drug is in response to a concentration of drug in the patient.

136. The method as recited in claim 119, wherein said monitoring is performed by a pulse oximeter and the modifying of said supply rate of the drug is in response to changes in a monitored blood oxygen level of the patient.

137. The method as recited in claim 119, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

138. The method as recited in claim 119, wherein said monitored physiological condition is blood pressure of the patient.

139. The method as recited in claim 119, wherein said record further details information regarding said monitored physiological condition.

140. The method as recited in claim 119, further comprising manually altering the delivery of drug.

141. The method as recited in claim 140, wherein said manual altering comprises increasing said drug delivery rate to the patient.

142. The method as recited in claim 119, further comprising generating a signal reflecting a state of at least one operating condition of said drug delivery device or a health monitor device performing said monitoring, and initiating alarms if said operating condition is unsatisfactory.

143. The method as recited in claim 142, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

144. A method of sedation by a non-anesthetist of a non-intubated, patient in need thereof without general anesthesia during a medical and/or surgical procedure, said method comprising:

infusing said non-intubated patient in need of sedation during said procedure with a drug dosage that is insufficient to result in general anesthesia;

electronically sensing at least one physiological condition of the patient during said procedure and providing an electronic signal reflecting said condition;

electronically receiving said signal and controlling said infusion in response thereto to sedate said patient effectively without general anesthesia during said procedure.

145. The method as recited in claim 144, wherein said controlling of said infusion comprises changing a current rate of drug delivery by applying an algorithm conforming to target-controlled infusion rates for the drug delivered to the patient during said procedure.

146. The method as recited in claim 144, further comprising detecting any failure of any one or more of said infusing step, said sensing step, and said controlling step, and generating an alarm in the event of a failure detection.

147. The method as recited in claim 144, wherein said controlling of said infusion comprises changing of a current rate of drug delivery to prevent said patient from entering a state of general anesthesia.

148. The method as recited in claim 144, wherein said drug is propofol.

149. The method as recited in claim 144, wherein said drug is remifentanil.

150. The method as recited in claim 144, wherein said drug is fentanyl.

151. The method as recited in claim 144, wherein said sensed physiological condition is selected from the group consisting of a brain activity, heart rate, blood saturation, expired carbon dioxide, ventilation, blood pressure, and patient consciousness level.

152. The method as recited in claim 144, wherein said physiological condition is ventilation and said drug delivery is decreased in the event the patient'"'"'s airway is obstructed.

153. The method as recited in claim 144, wherein said record is made of the drug infusion during said procedure.

154. The method as recited in claim 144, wherein said controlling of said infusion comprises modulating downward a current rate of drug delivery or raising an alarm if said sensed physiological condition of the patient moves outside of a preset safe range.

155. The method as recited in claim 154, further comprising raising an alarm if said sensed physiologic condition moves outside of a preset desirable range.

156. The method as recited in claim 154, wherein said safe range is identified by at least one threshold for measurement values for said monitored physiological condition.

157. The method as recited in claim 156, wherein said safe range is delimited by at least two thresholds concerning said physiological condition, wherein said thresholds designate different levels of concern for said patient when outside of said safe range.

158. The method as recited in claim 157, wherein said modulating of said current rate of drug delivery comprises first raising an alarm if obtained measurement values for said monitored physiological condition cross a first one of said thresholds and then lowering said current rate if said obtained measurement values for said monitored physiological condition cross a second one of said thresholds.

159. The method as recited in claim 157, wherein when it is sensed that measurements of said physiological condition have crossed one of said thresholds, said controlling said infusion comprises raising an alarm, and then, in the absence of manual intervention, automatically decreasing a current rate of drug delivery.

160. The method as recited in claim 144, wherein said infusing of said drugs is performed by a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

161. The method as recited in claim 144, wherein said physiological condition comprises brain activity of the patient.

162. The method as recited in claim 144, wherein said physiological condition comprises responsiveness of the patient to stimuli.

163. The method as recited in claim 144, wherein said physiological condition comprises blood pressure of the patient.

164. The method as recited in claim 144, further comprising manually altering infusion of the drug.

165. The method as recited in claim 164, wherein said manual altering comprises increasing a current rate of drug infusion.

166. The method as recited in claim 144, further comprising generating a signal reflecting a state of operation of said infusing, said sensing, and said controlling, and initiating alarms if said state of operation is unsatisfactory.

167. A method for sedating or providing pain relief to a patient undergoing a medical and/or surgical procedure without general anesthesia, said method comprising:

connecting to a patient a drug delivery device capable of controllable drug delivery to the patient during a procedure, said drug delivery device being coupled to a controller which controls the delivery of the drugs to the patient;

coupling a monitor to the patient;

said monitor providing feedback indicative of the patient'"'"'s effective spontaneous ventilation;

communicating said feedback to said controller;

said controller receiving said sensed data from said sensor and accessing parameters indicating normal feedback ranges for effective spontaneous ventilation during said procedure;

controlling dosage of a delivered drug with said controller so as to maintain effective spontaneous ventilation of said patient; and

recording said feedback and said dosage electronically in a recording device connected to said electronic controller.

168. The method as recited in claim 167, wherein said feedback ranges define a preset normal range of measurements concerning spontaneous ventilation for a patient undergoing said procedure, and wherein said controlling said dosage comprises decreasing a current drug delivery rate or raising an alarm if said sensed data moves outside of said preset normal range.

169. The method as recited in claim 168, wherein said preset normal range is identified by at least one threshold for said measurements.

170. The method as recited in claim 169, wherein said feedback ranges define at least two thresholds, and wherein said thresholds designate different levels of concern for said patient when said sensed date is outside of said preset normal range.

171. The method as recited in claim 167, wherein said feedback ranges define measurements evidencing effective spontaneous ventilation and onset of potentially undesirable patient conditions during said procedure.

172. The method as recited in claim 167, wherein the delivering of the drugs step is accomplished by target-controlled infusion.

173. The method as recited in claim 167, wherein said monitor comprises a pulse oximeter and the controlling dosage is performed in response to changes in a monitored blood oxygen level of the patient.

174. The method as recited in claim 167, wherein drugs are delivered by a mechanism selected from the group consisting of continuous infusion, target controlled intravenous infusion, bolus infusion, and combinations thereof.

175. The method as recited in claim 167, further comprising manually altering the delivery of drug.

176. The method as recited in claim 175, wherein said manual altering comprises increasing a current rate of drug delivery to the patient.

177. The method as recited in claim 167, further comprising generating a signal reflecting a state of at least one operating condition of said drug delivery device or said monitor, said signal being received by said controller, and said controller initiating alarms if said operating condition is unsatisfactory.

178. A method of providing sedation by a non-anesthetist medical personnel to a patient in need of pain relief and/or sedation during a medical and/or surgical procedure, said method comprising:

coupling an electronic drug delivery device to said patient and delivering to said patient one or more drugs at a predetermined drug delivery rate to provide sedation;

coupling a monitor to the patient and providing feedback indicative of the patient'"'"'s spontaneous ventilation;

communicating said feedback to a processor connected to said monitor, said processor comparing said signal to parameters that define whether a given patient is spontaneously ventilating effectively while receiving said drug at said drug delivery rate, and said processor generating a signal reflecting the ventilatory status of the patient and indicating modifications of said drug delivery to maintain proper ventilatory functions during said medical procedure; and

using said feedback to control said drug delivery device to maintain effective spontaneous ventilation of the patient.

179. The method as recited in claim 178, wherein said modifications of said drug delivery comprise an action selected from the group consisting of decreasing a current drug delivery rate, stopping drug delivery, and raising an alarm if proper ventilatory functions are endangered.

180. The method as recited in claim 178, wherein said parameters define a preset normal range for said feedback, and said range contains at least one threshold for said feedback.

181. The method as recited in claim 180, wherein said parameters define at least two thresholds concerning said feedback, and wherein said thresholds designate different levels of concern for said patient when measurements are outside of said preset normal range.

182. The method as recited in claim 179, wherein said parameters define measurements by said monitor that would evidence the onset of loss of effective spontaneous ventilation during said procedure.

183. The method as recited in claim 179, wherein said monitor is a pulse oximeter and controlling of said dosage comprises automatically modifying a supply rate of the drug in response to changes in a measured blood oxygen level of the patient.

184. The method as recited in claim 179, wherein said drug delivery device is adapted to deliver drugs according to a mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

185. The method as recited in claim 179, further comprising manually altering the delivery of drug.

186. The method as recited in claim 185, wherein said manual altering comprises increasing a current rate of drug delivery to the patient.

187. The method as recited in claim 179, further comprising generating a signal reflecting a state of at least one operating condition of said drug delivery device or said monitor, said signal being received by said controller, and said controller initiating alarms if said operating condition is unsatisfactory.

188. The method as recited in claim 179, further comprising communicating an alarm to said medical personnel in response to said signal, said alarm indicating possible modifications of said drug delivery to remedy a potential undesirable patient condition.

189. The method as recited in claim 188, wherein said possible modifications include manual altering of delivery of drug by said medical personnel.

190. A method of providing sedation to a patient in need of sedation during a medical and/or surgical procedure, said method comprising:

coupling an electronic drug delivery device to said patient and delivering to said patient one or more drugs at a drug delivery rate to provide sedation;

coupling a monitor to the patient and providing feedback indicative of at least one monitored physiological condition of the patient;

communicating said feedback to a processor connected to said monitor, said processor comparing said feedback to parameters that define whether a given patient is experiencing or in danger of experiencing an undesirable patient condition while receiving said drug at said drug delivery rate, and said processor generating a signal reflecting the monitored physiological condition of the patient and indicating modifications of said drug delivery to avoid said undesirable patient condition during said medical procedure; and

using said feedback to control said drug delivery device to avoid said undesirable patient condition.

191. The method as recited in claim 190, further comprising communicating an alarm to said medical personnel in response to said signal, said alarm indicating that a possible modification of said drug delivery may need to occur to avoid said undesirable patient condition.

192. The method as recited in claim 191, wherein said using step includes manual altering of delivery of drug by medical personnel.

193. The method as recited in claim 191, further comprising communicating an alarm to said medical personnel in response to said signal, said alarm indicating that a possible modification of said drug delivery may need to occur to remedy an undesirable patient condition.

194. The method as recited in claim 191, wherein said alarm alerts a medical personnel of possible therapeutic options;

said therapeutic options being identified by said comparison.

195. The method as recited in claim 190, wherein said monitor is selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer, a blood pressure monitor and a patient consciousness monitor.

196. The method as recited in claim 190, wherein said parameters define a preset normal range of said feedback for a patient undergoing said procedure, and wherein said modifications of drug delivery comprises decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

197. The method as recited in claim 196, wherein said preset normal range is identified by at least one threshold for said feedback.

198. The method as recited in claim 197, wherein said parameters define at least two thresholds concerning said feedback, and wherein said thresholds designate different levels of concern for said patient when said feedback is outside of said preset normal range.

199. The method as recited in claim 190, wherein delivering of the drugs is accomplished by target-controlled infusion.

200. The method as recited in claim 190, wherein said monitor is a brain activity monitor and said controlling of said drug delivery device comprises causing said drug delivery device to modify a supply rate of drug automatedly in response to said signal.

201. The method as recited in claim 190, wherein said monitor is a pulse oximeter and said controlling of said drug delivery device comprises causing said drug delivery device to modify a supply rate of drug in response to changes in a monitored blood oxygen level of the patient.

202. The method as recited in claim 190, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

203. The method as recited in claim 190, wherein said monitor is a blood pressure monitor.

204. The method as recited in claim 190, further comprising creating a record detailing control of said drug delivery during said procedure.

205. The method as recited in claim 204, wherein said record further details information regarding said monitored physiological condition.

206. The method as recited in claim 204, wherein said record further details alarms generated in response to said signal.

207. The method as recited in claim 190, wherein said drug delivery device is adapted to perform a delivery mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

208. The method as recited in claim 190, further comprising generating a second signal reflecting a state of at least one operating condition of said drug delivery device or said monitor, said signal being received by said processor, and said processor initiating alarms if said operating condition is unsatisfactory.

209. The method as recited in claim 208, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

210. The method as recited in claim 190, wherein said monitored physiological condition is the patient'"'"'s level of consciousness.

211. A method for sedating a patient undergoing one or more medical and/or surgical procedures without general anesthesia, said method comprising:

connecting to a patient a drug delivery device capable of controllable drug delivery to the patient during a procedure, said drug delivery device being coupled to an electronic controller which controls the delivery of the drugs to the patient;

attaching at least one patient health monitor device to a patient, said health monitor device generating a signal reflecting at least one monitored physiological condition of the patient;

sending said signal from said health monitor device to said electronic controller communicating a current value reflecting said monitored physiological condition of the patient;

accessing parameters for said monitored physiological condition, said parameters including values for said measurements of said monitored physiological condition where said values correlate to safe and effective sedation during said procedure;

comparing said measurements reflected in said received signal with said parameters; and

modifying a supply rate of the drugs according to software to maintain safe and effective sedation of the patient during said procedure, an extent of said modifying being dependent upon an extent by which said measurements are outside one or more ranges defined by said parameters.

212. The method as recited in claim 211, wherein said patient health monitor device is selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer, a blood pressure monitor and a patient consciousness monitor.

213. The method as recited in claim 211, wherein said one of said ranges is defined by values that establish a preset normal range of said measurements for a patient undergoing said procedure, and wherein said changing of said drug delivery rate comprises decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

214. The method as recited in claim 213, wherein said preset normal range is identified by at least one threshold for said measurements.

215. The method as recited in claim 214, wherein said values establish at least two thresholds concerning said physiological condition, and wherein said thresholds designate different levels of concern for said patient when measurements are outside of said preset normal range.

216. The method as recited in claim 211, wherein said values define measurements of said monitored physiological condition that evidence the onset of potentially undesirable patient conditions during said procedure.

217. The method as recited in claim 211, wherein the delivering of the drugs step is accomplished by target-controlled infusion.

218. The method as recited in claim 211, wherein said patient health monitor device is a brain activity monitor and said modifying of said supply rate of drug is in response to a concentration of drug in the patient.

219. The method as recited in claim 211, wherein said patient health monitor device is a pulse oximeter and the modifying of said supply rate of the drug is in response to changes in a monitored blood oxygen level of the patient.

220. The method as recited in claim 211, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

221. The method as recited in claim 211, wherein said monitor device is a blood pressure monitor.

222. The method as recited in claim 211, further comprising creating a record detailing delivering of said drug during said one or more procedures.

223. The method as recited in claim 222, wherein said record further details information regarding said monitored physiological condition.

224. The method as recited in claim 211, further comprising manually altering the delivery of drug.

225. The method as recited in claim 224, wherein said manual altering comprises increasing a current rate of drug delivery to the patient.

226. The method as recited in claim 211, further comprising generating a signal reflecting a state of at least one operating condition of said drug delivery device or said patient health monitor device, said signal being received by said controller, and said controller initiating alarms if said operating condition is unsatisfactory.

227. The method as recited in claim 226, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

228. The method as recited in claim 211, wherein said monitored physiological condition is the patient'"'"'s level of responsiveness.