Apparatus, method and drug products for providing a conscious patient relief from pain and anxiety associated with medical or surgical procedures

• US 20060093785A1
• Filed: 09/23/2005
• Published: 05/04/2006
• Est. Priority Date: 06/03/1998
• Status: Abandoned Application

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Application Number:
  US11/233,487
• Publication Number:
  US 20060093785A1
• Time in Patent Office: Days
• US Class Current: 428/121
• 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 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 2205/3561 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 2209/06 Packaging for specific medical equipment
• 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: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/22 : Anxiolytics
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 428/2419 : Fold at edge

Abstract

Disclosed is drug delivery 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. Mixtures of sedative and analgesic drugs are adapted for safe and effective administration by devices to provide and maintain drug infusions that do not push the patient into unconsciousness and/or general anesthesia. Drug delivery devices are also disclosed that include the use of stored parameters and/or values that correlate to drug mixture delivery during a procedure, and a patient health monitor to measure and send signals regarding a patient health condition to a processor.

Claims

1. A method of managing pain and anxiety of a patient undergoing a medical procedure without general anesthesia, said method comprising the steps of:

infusing a combination drug of propofol and remifentanil into said patient in a ratio and with a dosage sufficient to manage pain and anxiety without causing general anesthesia;

monitoring one or more of said patient'"'"'s physiological conditions and controlling said infusion rate to provide effective management of pain and anxiety without impairing spontaneous ventilation of the patient.

2. A method as recited in claim 1 in which said monitored physiological condition is the end tidal CO₂.

3. A method as recited in claim 1 in which said monitored physiological condition is oxygen saturation.

4. A method as recited in claim 1 in which said ratio of propofol to remifentanil is greater than 500 mcg to 1 mcg.

5. A method as recited in claim 4 in which said ratio of propofol to remifentanil is about 600 mcg to 1 mcg.

6. A method as recited in claim 1 in which said microprocessor is pre-programmed to infuse said drug with a dosage rate predetermined by the patient'"'"'s condition, said pre-program being subject to being overridden in the event the monitoring detects an undesirable change in the patient'"'"'s physiological condition.

7. A method as recited in claim 1 in which said microprocessor is preprogrammed to infuse said drug with a dosage rate predetermined by the ratio of propofol to remifentnail.

8. A method of managing pain and anxiety of a patient undergoing a medical procedure without general anesthesia, said method comprising the steps of:

infusing a combination drug having a ratio of about 600 mcg of propofol to 1 mcg of remifentanil into said patient; and

monitoring one or more of said patients physiological conditions and controlling said infusion rate to provide effective pain and anxiety management without impairing the physiological condition of the patient.

9. A prepackaged combination drug for infusion into a patient having a need for pain and anxiety control during a medical procedure without general anesthesia;

said drug comprising;

a combination drug of remifentanil and propofol in which the ratio of propofol to remifentanil is more than about 500 mcg to 1 mcg so as to provide adequate pain management and anxiety control without suppressing the ventilation of said patient.

10. A prepackaged combination drug as set forth in claim 9 in which said drug is formed of a lyophilic power of remifentanil and an emulsion of propofol.

11. A combination drug as recited in claim 9 in which said drug is comprises an aqueous solution.

12. A combination drug as recited in claim 9 in which said ratio of propofol to remifentanil is about 600 mcg to 1 mcg.