Resuscitation kit system and method and pre-use protocols for a sedation and analgesia system

• US 20040084047A1
• Filed: 08/08/2003
• Published: 05/06/2004
• Est. Priority Date: 08/08/2002
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Granted Patent: US 7,316,231 B2
• Time in Patent Office: Days
• US Class Current: 128/203.13
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 7/02 Stethoscopes acoustic details thereof G10K11/00
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0084 self-reinflatable by elasticity, e.g. resuscitation squeeze bags
• CPC Class Codes: A61M 16/021 operated by electrical means A61M16/202 – A61M16/205 take precedence
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention provides a sedation and analgesia system having an emergency medical kit, where the medical kit is designed to meet the specific needs of medical emergencies related to the delivery of sedatives, analgesics, and/or amnestics. The invention further provides a sedation and analgesia system with an emergency medical kit having policies along with automated and semi-automated pre-use checks necessary to ensure that components of the kit are present, functioning properly, and that perishable components within the kit have not expired.

Claims

1. A sedation and analgesia system comprising:

a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient;

a user interface;

a drug delivery controller supplying one or more drugs to the patient;

a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition;

an electronic controller interconnected with the patient health monitor, the user interface, the drug delivery controller, and the memory device storing the safety data set, wherein said electronic controller receives said signal and in response to said signal manages the application of the drugs in accord with the safety data set; and

an emergency medical kit, wherein said emergency medical kit is designed to meet the specific needs of medical emergencies related to the delivery of at least one of sedatives, analgesics, and amnestics.

2. The sedation and analgesia system of claim 1, wherein said emergency medical kit is detachably coupled to said sedation and analgesia system.

3. The sedation and analgesia system of claim 1, wherein said emergency medical kit is permanently affixed to said sedation and analgesia system.

4. The sedation and analgesia system of claim 1, wherein said emergency medical kit comprises:

emergency back-up ventilation equipment;

emergency back-up emesis equipment; and

emergency airway management and intubation equipment.

5. The sedation and analgesia system of claim 4, wherein said emergency medical kit further comprises at least one of:

emergency back-up monitoring equipment;

one or more vasopressors;

one or more cardiac rate stimulation drugs;

one or more anaphylaxis treatment drugs;

one or more bronchodilators;

one or more anti-arrhythmia drugs;

one or more myocardial ischemia drugs; and

one or more pharmacological antagonists.

6. The sedation and analgesia system of claim 5, wherein said emergency medical kit further comprises at least one of dextrose, furosemide, intravenous (I.V.) catheters, I.V. tubing, syringes, needles, and alcohol swabs.

7. The sedation and analgesia system of claim 1, wherein said emergency medical kit includes a tamper evident indicia.

8. The sedation and analgesia system of claim 7, wherein said tamper evident indicia uses electronic technology that can be sensed by said sedation and analgesia system.

9. The sedation and analgesia system of claim 8, wherein said sedation and analgesia system automatically senses when said tamper evident indicia is invalid and notifies said user of said invalid indicia.

10. The sedation and analgesia system of claim 9, wherein said electronic technology is embedded radio frequency (RF) technology.

11. The sedation and analgesia system of claim 7, wherein said user interface includes a prompt requiring a user to confirm that said tamper evident indicia is undisturbed and that a pre-determined period of non-use has not elapsed for said emergency medical kit before granting access to said sedation and analgesia system.

12. The sedation and analgesia system of claim 1, wherein said user interface includes an integrated checklist for said emergency medical kit, said checklist comprising a list of required supplies for said emergency medical kit.

13. A method for utilizing a resuscitation kit system and pre-use protocols for a sedation and analgesia system, comprising:

providing said sedation and analgesia system, wherein said sedation and analgesia system comprises an emergency medical kit that is tailored specifically to emergencies that may result from the use of said sedation and analgesia system;

providing a checklist for said emergency medical kit, wherein said checklist comprises a listing of required supplies for said emergency medical kit;

performing a checklist procedure, where said checklist procedure comprises determining whether each of said supplies for said emergency medical kit meets pre-defined requirements;

if all said supplies required for said emergency medical kit have not complied with said requirements of checklist, performing at least one of restocking, repairing, and replacing components for said emergency medical kit to meet said pre-defined requirements of said checklist;

if all said supplies required for said emergency medical kit have complied with said requirements of checklist, sealing said emergency medical kit with a tamper evident seal;

ascertaining whether at least one of breaking of said tamper evident seal and said emergency medical kit remaining unused for a predetermined period of time has occurred; and

if at least one of breaking of said tamper evident seal, said emergency medical kit remaining unused for a predetermined period of time, and using said emergency medical kit has occurred, repeat step of performing said checklist procedure.

14. The method of claim 13, wherein said checklist for said emergency medical kit is integrated into a user interface for said sedation and analgesia system.

15. A method for utilizing a sedation and analgesia system comprising a user interface, wherein said sedation and analgesia system is integrated with an emergency medical kit comprising a tamper evident seal, comprising:

first prompting a user to confirm at least one of that said tamper evident seal of said emergency medical kit is intact and that a pre-determined time period of non-use has not elapsed;

if the response to said first prompting is “

no”

, disabling said sedation and analgesia system;

if the response to said first prompting is “

yes”

, second prompting said user to confirm that a defibrillator is present and functional;

if the response to said second prompting is “

no”

, disabling said sedation and analgesia system;

if the response to said second prompting is “

yes”

, third prompting said user to confirm that additional vials of a drug being administered by said sedation and analgesia system are present;

if the response to said third prompting is “

no”

, disabling said sedation and analgesia system; and

if the response to said third prompting is “

yes”

, allowing said sedation and analgesia system to be operated.

16. The method of claim 15, wherein said first prompting occurs when said sedation and analgesia system is activated and before drug delivery commences.

17. The method of claim 15, wherein said tamper evident seal is electronic and said response to said first prompting is automatically generated by said sedation an analgesia system.

18. The method of claim 17, wherein said tamper evident seal contains RF technology.

19. The method of claim 17, wherein at least one of said responses to said second prompting and said third prompting is automatically generated by said sedation an analgesia system.

20. A method for utilizing a resuscitation kit system and pre-use protocols for a sedation and analgesia system, comprising:

providing said sedation and analgesia system, wherein said sedation and analgesia system comprises an emergency medical kit that is tailored specifically to emergencies that may result from the use of said sedation and analgesia system;

performing automated pre-use checks, wherein said automated pre-use checks comprise confirming that a tamper evident seal of said emergency medical kit is intact, that a pre-determined time period of non-use of said emergency medical kit has not elapsed, that a defibrillator is present and functional, and that additional vials of a drug being administered by said sedation and analgesia system are present;

querying whether said sedation and analgesia system has passed said automated pre-use checks;

if the response to said querying is “

no”

, disabling said sedation and analgesia system and conducting suitable modifications necessary to comply with said automated pre-use checks; and

if the response to said querying is “

yes”

, allowing the operation of drug administration features associated with sedation and analgesia system.

21. The method of claim 20, wherein said automated pre-use checks further comprise:

checking that patient information has been entered and that said information is within predetermined safe boundaries for use;

checking the performance of the I.V. purge;

checking that a pulse oximeter is reporting respiratory rate;

checking that a drug cassette is certified and has not been used; and

checking that a drug vial is certified and has not been used.

22. The method of claim 21, wherein said automated pre-use checks further comprise at least one of:

checking that a battery associated with said sedation and analgesia system is charged to a predetermined level;

checking that there is pressure in gas supply lines associated with said sedation and analgesia system;

checking that a capnometer is reporting respiratory rate; and

checking for the presence of AC power.

23. The method of claim 20, wherein said tamper evident seal contains embedded RF technology.