Drug delivery in association with medical or surgical procedures

• US 8,882,703 B2
• Filed: 03/27/2007
• Issued: 11/11/2014
• Est. Priority Date: 06/03/1998
• Status: Expired due to Fees

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US11/727,575
• Publication Number:
  US 20070213658A1
• Time in Patent Office: 2,786 Days
• Field of Search: 604 65- 66
• 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. 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 that acts upon the patent'"'"'s central nervous system at a dosage that is insufficient to result in general anesthesia;

sensing at least one physiological condition of the patient during said procedure with one or more monitors selected from the following;

pulse oximeter, heartrate, blood pressure, carbon dioxide, EEG, and ventilator;

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

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

2. The method as recited in claim 1 in which said generated signal comprises an audible alarm.

3. The method as recited in claim 1 in which said modification of said infusion is performed manually.

4. The method as recited in claim 1 in which said modification of said infusion is performed automatically in response to said signal.

5. The method as recited in claim 1 in which said modification is controlled electronically.

6. The method as recited in claim 1 in which said drug is selected from a group comprising fentanil, remifentanil, propofol, and morphine.

7. The method as recited in claim 1 in which said drug is remifentanil.

8. The method as recited in claim 1 in which said method includes the provision of a patient controlled device enabling the non-anesthetist to manually alter a rate of infusion during 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.

9. The method as recited in claim 1 in which said physiological condition is selected from the group consisting of brain activity and patient consciousness.

10. A method of providing safe and effective sedation, analgesia and/or amnestic drugs to a non-intubated patient undergoing a medical procedure by a procedural physician so as to safely avoid the cost of ventilation equipment and/or an operating room, said method comprising the steps of:

connecting said non-intubated patient to one or more physiological monitors capable of detecting signals of ventilation suppression and/or airway obstruction;

delivering said monitored signals to a logic chip having access to a memory device containing data representative of safe and/or unsafe ventilation conditions;

an infusion system for infusing a drug into said patient for providing sedation, analgesia and/or amnesia, said infusion system being primarily controlled by said logic chip;

comparing said monitored signals with said data on said memory device and for providing an alarm signal in the event said patient'"'"'s condition becomes unsafe; and

visually and/or audibly advising said procedural physician of unsafe conditions for said non-intubated patient.

11. The method as recited in claim 10 in which said physiological condition is selected from the group consisting of brain activity and patient consciousness.

12. A method as recited in claim 10 in which said drug has a very short effective time period in said patient so as to enable said patient to quickly return to a safe condition in the event of an alarm and after said infusion is terminated.

13. A method as recited in claim 10 in which said drug is propofol and/or remifentanil.

14. An electronic method of providing safe and effective sedation, analgesia and/or amnestic drugs to a non-intubated patient undergoing a medical procedure by a procedural physician so as to safely avoid the cost of ventilation equipment and/or an operating room, said method comprising the steps of:

infusing said non-intubated patient with a sedative, pain relieving and/or amnestic drug at a dosage rate sufficient to achieve all levels of sedation, but insufficient to result in general anesthesia, said drug being a short acting, fast dissipating drug;

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

ascertaining whether said sensing reflects an adverse physiological condition;

electronically generating a signal in the event of said patient is in an adverse physiological condition an adverse change in said physiological condition, controlling said infusion so as to terminate and/or reduce said infusion and permitting said infused drug to dissipate in response to said adverse physiological condition.

15. The method as recited in claim 14 in which said physiological condition is selected from the group consisting of brain activity and patient consciousness.

16. A method as recited in claim 14 in which said control of said infusion is automatic.

17. A method as recited in claim 14 in which said control of said infusion is manual.

18. A method as recited in claim 14 in which said drug is selected from the group comprising propofol and remifental.