Drug delivery in association with medical or surgical procedures

• US 20070213658A1
• Filed: 03/27/2007
• Published: 09/13/2007
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall
• Granted Patent: US 8,882,703 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 various methods and devices 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 devices safely and effectively provide and maintain drug infusions that do not push the patient into unconsciousness and/or general anesthesia. Devices according to embodiments of the invention include the use of stored 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 or other computational device.

Claims

1-96. -96. (canceled)

97. A method of providing effective sedation and/or pain relief by a non-anesthetist without general anesthesia to a non-intubated patient during a medical and/or surgical procedure, said method comprising:

infusing said non-intubated patient with a sedative and/or pain relieving drug dosage that is insufficient to result in general anesthesia;

sensing at least one physiological condition of the patient during said procedure;

generating a signal in the event said psysiological condition of said patient becomes unsafe; and

modifying said infusion of said drug so as to return said patient to a safe physiological condition.

98. The method as recited in claim 97 in which said generated signal comprises an audible alarm.

99. The method as recited in claim 97 in which said modification of said infusion is performed manually.

100. The method as recited in claim 97 in which said modification of said infusion is performed automatically.

101. The method as recited in claim 97 in which said modification is controlled electronically.

102. The method as recited in claim 97 in which said drug is selected from a group comprising fentanil, remifentanil, propofol, and morphine.

103. The method as recited in claim 97 in which said drug is a mixture of drugs selected from a group comprising fentanil, remifentanil, propofol and morphine

104. The method as recited in claim 97 in which said method additionally includes the provision of a patient controlled device enabling the patient to manually alter a rate of infusion during and/or after said procedure at any dosage level that is insufficient to result in general anesthesia and as long as the patient'"'"'s physiological condition does not become unsafe.

105. An apparatus for use by a non-anesthetist medical person in connection with the performance of a medical or surgical procedure, said apparatus providing effective sedation and/or pain relief without general anesthesia to a spontaneously-ventilating, non-intubated patient, said apparatus comprising:

a) a drug delivery device adapted to deliver a drug to a patient during said procedure in so as to effectively sedate and/or manage pain without resulting in general anesthesia of the patient;

b) at least one sensor coupled to said patient for providing monitored data of at least one physiological condition of the patient in connection with said medical or surgical procedure; and

c) a controller connected to said sensor for receiving said monitored data and for activating an alarm in the event said monitored data becomes abnormal.

106. The apparatus as recited in claim 105 in which said drug delivery device is interconnected to said controller to eliminate unsafe condition.

107. The apparatus as recited in claim 105 in which said apparatus contains a panic switch to terminate drug delivery in the event said physiological condition becomes unsafe.

108. The apparatus as recited in claim 105 in which said apparatus additionally includes a patient controlled device to enable the patient manually alter a rate of infusion during and/or after said procedure at any dosage level that is insufficient to result in general anesthesia and as long as the patient'"'"'s psysiological condition does not become unsafe.

109. A method of providing effective sedation and/or pain relief without general anesthesia to a non-intubated patient during a medical and/or surgical procedure, said method comprising:

infusing said non-intubated patient with a sedative and/or pain relieving drug dosage that is insufficient to result in general anesthesia;

sensing at least one physiological condition of the patient during and/or after said procedure;

generating a signal in the event said psysiological condition of said patient becomes unsafe;

modifying said infusion of said drug so as to return said patient to a safe physiological condition, and

enabling said patient to manually alter the rate of infusion during and after said procedure at any dosage level that is insufficient to result in general anesthesia and as long as the patient'"'"'s psysiological condition does not become unsafe.

110. The method as recited in claim 109 in which said generated signal comprises an audible alarm.

111. The method as recited in claim 109 in which said modification of said infusion is performed manually.

112. The method as recited in claim 109 in which said modification of said infusion is performed automatically.

113. The method as recited in claim 109 in which said modification is controlled electronically.

114. The method as recited in claim 109 in which said drug is selected from a group comprising fentanil, remifentanil, propofol, and morphine.

115. The method as recited in claim 109 in which said drug is a mixture of drugs selected from a group comprising fentanil, remifentanil, propofol and morphine.