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

• US 20020017296A1
• Filed: 07/18/2001
• Published: 02/14/2002
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: Randall S. Hickle
• Original Assignee: Randall S. Hickle
• Inventors: Hickle, Randall S.
• Granted Patent: US 6,745,764 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• 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

A care system and associated methods are provided for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures. The care system facilitates a procedural physician'"'"'s safely and efficaciously providing conscious sedation to a patient by providing a responsiveness monitoring system which monitors the responsiveness of the patient and generates a value representing the level of patient responsiveness. In further aspects of the invention, the responsiveness monitoring system is an automated system which includes patient query and response devices. Additional embodiments of the system and methods are directed to alleviating patient pain or discomfort while enabling safe patient controlled drug delivery in correlation with the monitoring of patient health conditions.

Claims

1. A care system for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures said system comprising:

a patient health monitor device coupled to a patient and generating a signal reflecting at least one physiological condition of the patient;

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 patient physiological condition;

an electronic controller interconnected between the patient health monitor, the drug delivery controller and the safety data set;

wherein said electronic controller manages the application of the drugs in accord with the safety data set.

2. A care system as recited in claim 1 wherein said drugs are one or more sedatives, analgesics or amnestics.

3. A care system as recited in claim 1 wherein said drug is delivered in gaseous form.

4. A care system as recited in claim 1 wherein said system also includes airway circuitry providing a drug and oxygen mixture to the patient.

5. A care system as recited in claim 4 wherein said system also includes a scavenging vacuum pump which exhausts patient exhalations.

6. A care system as recited in claim 4 wherein said system also includes a disposable face mask coupled to said airway circuitry and engaging the patient'"'"'s face.

7. A care system as recited in claim 6 wherein said face mask includes a mask base with a pliable outer edge and adhesive for sealingly engaging the patient'"'"'s face and a quick release mechanism which allows rapid removal of the mask for emergency access to the patient'"'"'s face.

8. A care system as recited in claim 6 wherein said face mask includes a monitoring device which monitors a patient'"'"'s end tidal CO₂ levels in the patient'"'"'s exhaled air stream.

9. A care system as recited in claim 6 wherein said face mask includes a monitoring device which monitors the acoustical levels of a patient'"'"'s breathing.

10. A care system as recited in claim 6 wherein said face mask includes an airstream flow measurement device.

11. A care system as recited in claim 1 wherein said system includes means for delivering at least one of the drugs intravenously.

12. A care system as recited in claim 1 wherein said electronic controller includes logic for receiving the signal reflecting the at least one physiological condition and comparing said signal with the safety data set and managing the application of the drug to the patient in accord with the safety data set.

13. A care system as recited in claim 1 wherein said electronic controller is controlled by software which accesses the safety data set.

14. A care system as recited in claim 1 wherein said patient health monitor device comprises a pulse oximeter that monitors the oxygen level in the patient'"'"'s blood.

15. A care system as recited in claim 14 wherein said system includes a second health monitor device coupled to a patient and generating values reflecting a second physiological condition of a patient;

and wherein the safety data set also reflects safe and undesirable parameters of said second patient physiological condition and said electronic controller is interconnected with said second patient health monitor and manages application of the drug in accord with said safety data set.

16. A care system as recited in claim 15 wherein said second health monitor device comprises a capnometer that monitors the carbon dioxide level in the patient'"'"'s inhaled and exhaled gases.

17. A care system as recited in claim 15 wherein said second health monitor device comprises an EKG device that monitors a patient'"'"'s heart activity.

18. A care system as recited in claim 15 wherein said second health monitor device comprises an acoustical monitoring device that monitors the acoustical characteristics of a patient'"'"'s inhaled and exhaled breaths.

19. A care system as recited in claim 1 wherein at least one of said drugs is propofol.

20. A care system as recited in claim 1 wherein at least one of said drugs is sevoflurane.

21. A care system as recited in claim 1 wherein at least one of said drugs is nitrous oxide.

22. A care system as recited in claim 1 wherein at least one of said drugs is a narcotic delivered as an intravenous infusion.

23. A care system as recited in claim 1 wherein at least one of said drugs is delivered as a nebulized aerosol to be inhaled.

24. A care system as recited in claim 1 wherein said system includes means for delivery of at least one of said drugs transdermally.

25. A care system as recited in claim 1 wherein at least one of said drugs is dexmedetamidine.

26. A care system as recited in claim 1 wherein at least one of said drugs is epibatadine.

27. A care system as recited in claim 15 wherein said second health monitor device is a patient consciousness monitor.

28. A care system as recited in claim 27 wherein said patient consciousness monitor includes an automated patient query and response system.

29. A care system as recited in claim 1 wherein said drug delivery controller comprises a patient-controlled drug dosage device coupled to the patient and interconnected to the electronic controller.

30. A care system as recited in claim 29 wherein said electronic controller is programmed with lock-out parameters that prevent activation of said patient-controlled drug dosage device.

31. A care system as recited in claim 1 wherein said system includes at least one alarm device that sounds when said signal is determined to fall within said undesirable parameters of said safety data set.

32. A care system as recited in claim 31 wherein said electronic controller curtails drug delivery upon the sounding of said alarm device.

33. A care system as recited in claim 31 wherein said electronic controller increases the delivery of oxygen to the patient upon the sounding of said alarm device.

34. A care system as recited in claim 4 wherein said system includes a LIFO oxygen delivery mechanism.

35. A care system according to claim 31, wherein said system also includes a display device with an alarm box portion which displays a representation of the patient physiological condition associated with the sounded alarm in that alarm box portion.

36. A care system as recited in claim 1 wherein said apparatus includes a display device showing data reflecting predicted concentration levels of drugs.

37. A care system as recited in claim 14 wherein activation of said first and second monitors are synchronized with one another.

38. A care system as recited in claim 1 wherein said system includes a display device showing data reflecting the patient'"'"'s A-a gradient.

39. A care system as recited in claim 1 wherein said system includes a display device having portions showing patient physiological parameters and wherein said portions are color coded.

80. A care system as recited in claim 4 wherein said drug and oxygen mixture is provided to the patient in accord with the respiratory rate of the patient.

81. A care system as recited in claim 4 wherein said drug and oxygen mixture is provided to the patient in accord with the effective minute ventilation of the patient.

82. An apparatus as recited in claim 35 wherein said display device is a heads-up type device mounted on a support and capable of being viewed by the practitioner at eye level.

84. A care system as recited in claim 2 wherein said system includes at least one drug dosage container mounted on said apparatus containing at least one dosage of drug capable of reversing the effect of the one or more sedatives, analgesics or amnestics delivered to the patient.

92. A care system as recited in claim 1 wherein said system includes at least one system state monitor which generates a signal reflecting the state of at least one operating condition of the system and which is coupled to the electronic controller;

and wherein said safety data set also reflects safe and undesirable parameters of at least one operating condition of the apparatus.

93. A care system as recited in claim 92 wherein said system state monitor is an oxygen source pressure sensor that measures the flow of oxygen to the patient.

94. A care system as recited in claim 92 wherein said system state monitor indicates whether there has been a power failure in the system.

95. A care system as recited in claim 92 wherein said electronic controller activates an attention-commanding device in response to said signal reflecting the state of at least one operating condition of the apparatus.

96. A care system as recited in claim 92 wherein said system state monitor is a drug source flow sensor that measures flow of drug to the patient.

40. A care system for facilitating a nonanesthetist'"'"'s safely and efficaciously providing conscious sedation to a patient undergoing a medical or surgical procedure, said system comprising:

a patient health monitor device coupled to a patient and generating a value reflecting at least one physiological condition of the patient;

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

a means for monitoring the consciousness of the patient coupled to the patient and generating a value representing the level of patient consciousness;

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

an electronic controller interconnected between the patient health monitor, the drug delivery controller, and the safety data set;

wherein said electronic controller manages application of the drugs to the patient in accord with the safety data set.

41. A method for alleviating pain and anxiety in connection with medical and surgical procedures, said method comprising the steps of:

a) connecting to a patient a drug delivery device having a drug delivery controller supplying one or more drugs, said drug delivery controller being coupled to an electronic controller which controls the delivery of the drugs to the patient;

b) attaching at least one patient health monitor device to a patient, which health monitor device generates a value reflecting at least one physiological condition of a patient and is coupled to said electronic controller;

c) accessing a memory device which stores a safety data set reflecting parameters of at least one patient physiological condition;

d) delivering the drugs to the patient in accord with the safety data set.

42. A method as recited in claim 41 in which said drug delivery device is a patient-controlled drug dosage device.

43. A method as recited in claim 41, wherein the method also includes the step of performing an automated assessment of the patient'"'"'s physiological state.

44. A method as recited in claim 43, wherein the automated assessment is performed pre-operatively.

45. A method as recited in claim 44 in which the pre-op assessment includes determining a patient sedation threshold limit.

46. A method as recited in claim 43 in which the electronic controller manages drug delivery in accord with the automated assessment.

47. A method as recited in claim 41 in which the drug is propofol.

48. A method as recited in claim 4l in which the drug is sevoflurane.

49. A method as recited in claim 41 in which the delivering of the drugs step is accomplished by target-controlled infusion.

50. A method as recited in claim 49 in which the drug is initially delivered in an amount overshooting a steady state target drug level.

51. A method as recited in claim 41 in which the patient health monitor device is a pulse oximeter and the application of drug is managed in accord with the oxygen level of the patient'"'"'s blood.

59. An apparatus as recited in claim 42 wherein said drug delivery controller comprises a patient-controlled drug administration device.

60. An apparatus as recited in claim 42 wherein said apparatus also includes a display device displaying the value of the signal reflecting the consciousness level of the patient.

52. An apparatus for delivering drugs to a conscious patient, said apparatus comprising:

a drug delivery controller delivering a drug to a patient;

an electronic controller connected to the drug delivery controller for varying the rate of delivery of drug to a patient;

an automated consciousness monitoring system which ensures the consciousness of a patient and generates a signal reflecting the consciousness level of a patient; and

wherein said electronic controller is capable of varying the delivery of drug to the patient in accord with said signal.

53. An apparatus as recited in claim 52 wherein said automated consciousness monitoring system comprises a stimulator device which commands a patient;

and a response device for activation by the patient in response to the stimulator device;

said response device generating signals having values reflecting the time it takes for the patient to activate the response device in response to the stimulator device, and providing said signals to and to the electronic controller.

54. An apparatus as recited in claim 53 wherein said stimulator device has multiple urgency or intensity levels.

55. An apparatus as recited in claim 53 in which the stimulator device comprises a speaker that provides an auditory instruction to a patient.

56. An apparatus as recited in claim 53 in which the stimulator device comprises a vibrator.

57. An apparatus as recited in claim 53 wherein the stimulator device is located in close proximity to the response device.

58. An apparatus as recited in claim 52, wherein said apparatus also includes at least one patient health monitor device which generates a signal reflecting at least one physiological condition of a patient.

77. An apparatus as recited in claim 52, wherein said apparatus further includes an attention-commanding device which receives said signal reflecting the consciousness level of the patient and notifies the nonanesthetist in the event said consciousness level changes to a level outside an acceptable range.

78. An apparatus as recited in claim 77 wherein said attention-commanding device is an audible alarm.

79. An apparatus as recited in claim 77 wherein said apparatus further includes a display device which displays the value reflecting the consciousness level of the patient upon the activation of said attention-commanding device and visually displays an action to be taken by said electronic controller in the event said consciousness level is outside of an acceptable range.

61. A method for relieving patient pain or anxiety, said method comprising the steps of:

a) monitoring at least one physiological condition of a patient with at least one electronic health monitor device;

b) electronically monitoring the level of consciousness of a patient; and

c) electronically managing the delivery of pain or anxiety relieving drugs to a patient in accord with the at least one physiological condition of a patient and the level of consciousness of a patient.

62. A method as recited in claim 61 in which the electronic health monitor device is a pulse oximeter and the delivery of drugs is electronically managed in accord with the level of oxygen in the patient'"'"'s blood.

63. A method as recited in claim 61 in which the monitoring of the level of consciousness of a patient further comprises the steps of:

a) automatedly commanding the attention of the patient with a stimulus;

b) electronically receiving the patient'"'"'s response to the stimulus;

c) generating a signal having a value reflecting the level of consciousness of a patient as a function of the time it took for the patient to respond to the stimulus.

64. A method as recited in claim 61 in which the delivery of drugs is accomplished through target controlled intravenous infusion.

65. A method as recited in claim 61 in which the delivery of drugs is accomplished by a patient-controlled drug delivery device.

66. An integrated patient interface apparatus for use with a drug delivery and patient monitoring system, said system including an electronic controller which electronically manages the delivery of drugs to a patient, said patient interface apparatus comprising:

a portion for receiving a patient'"'"'s hand;

a patient-controlled drug dosage request device integrated into said portion and having a movable member capable of being activated by the patient to request a change in dosage of drug; and

wherein said drug dosage request device is electronically coupled to said electronic controller; and

a patient health monitor device electronically coupled to said electronic controller.

67. An apparatus as recited in claim 66 in which said patient health monitor is a consciousness monitor.

68. An apparatus as recited in claim 66 in which said patient health monitor is a pulse oximeter.

69. An apparatus as recited in claim 66 which also includes a patient response device integrated into said hand cradle and having a movable member capable of being activated by a patient in response to a stimulus;

and wherein said patient response device is electronically coupled to said electronic controller and produces a value reflecting the level of consciousness of the patient, providing said value to said electronic controller.

70. An apparatus as recited in claim 68 wherein said pulse oximeter is mounted on said portion for receiving the patient'"'"'s hand.

71. An apparatus as recited in claim 66, wherein said patient health monitor includes a blood pressure monitor mounted on said portion for receiving a patient'"'"'s hand and removably attachable to the patient.

72. An apparatus as recited in claim 66 wherein said patient health monitor includes a blood pressure cuff.

83. An apparatus as recited in claim 66 wherein said patient health monitor is a pulse oximeter mounted on an earpiece removably attachable to the patient.

73. A method for electronically tracking recurring revenues generated by use of a conscious sedation care system at the location of the user, said method comprising the steps of:

a) providing a medical apparatus at the location of the user, said apparatus having a user access device, and a memory device storing data representing metered system operation values and patient informational data;

b) providing a password to said apparatus enabling access to said memory device;

c) reading said metered system operation values and patient informational data and transmitting said values and data to a remote location;

d) calculating a revenue based on said system operation values; and

e) providing a record at the remote location reflecting said revenue and patient informational data.

74. A method as recited in claim 73 wherein said method includes the step of printing a record of said revenues at the remote location.

75. A method as recited in claim 73 wherein said method includes the step of printing a patient invoice at the remote location.

76. A method as recited in claim 73 wherein said medical apparatus includes a printer providing an automated record of said system operation values and patient informational data at the location of the user.

85. A care system for alleviating pain or discomfort in a conscious patient while simultaneously enabling safe patient control of said pain or discomfort, said apparatus comprising:

a patient health monitor device coupled to the patient and generating a value reflecting at least one physiological condition of the patient;

a memory device storing a safety data set reflecting parameters of the at least one patient physiological condition;

a patient-controlled drug dosage request device which generates a signal indicating the patient'"'"'s request for an adjustment in drug dosage and having a drug delivery controller;

an electronic controller interconnected between the patient health monitor, the patient-controlled drug dosage increase/decrease request device, and the safety data set;

wherein said electronic controller manages the application of the drugs in accord with the safety data set.

86. A care system as recited in claim 85 wherein said memory device also stores programmed parameters indicating desired drug dosages;

87. An apparatus as recited in claim 85 wherein said patient health monitor device is a pulse oximeter.

88. A care system as recited in claim 85 wherein said safety data set reflects safe and undesirable of at least one patient physiological condition, and said electronic controller manages the application of the drugs in response to said signal generated by patient-controlled drug dosage request device in accord with the stored parameters in said memory device.

89. An apparatus as recited in claim 85 wherein said electronic controller is programmed with lock-out parameters that prevent patient self-administration of drugs at specified levels of drugs.

90. An apparatus as recited in claim 85 wherein said electronic controller is programmed with lock-out parameters that prevent patient self-administration of drugs at specified rates of changes in drug levels.

91. An apparatus as recited in claim 88 wherein said apparatus includes at least one attention commanding device which activates when said patient physiological condition value falls within the undesirable range of said safety data set.