Apparatus for drug delivery in association with medical or surgical procedures

• US 7,201,734 B2
• Filed: 08/03/2004
• Issued: 04/10/2007
• Est. Priority Date: 06/03/1998
• Status: Expired due to Term

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/909,435
• Publication Number:
  US 20050010166A1
• Time in Patent Office: 980 Days
• Field of Search: 600/300, 600/301, 604/65, 604/66, 604/67, 604/131, 128/204.23, 128/206.25
• US Class Current: 604/67
• 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 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.

Claims

1. A device to provide sedation to a patient, said device comprising:

a drug delivery mechanism for delivering a drug dosage rate of sedative to said patient during a procedure;

a patient health monitor adapted so as to be coupled to a patient during said procedure, said monitor generating a signal reflecting measurements of at least one monitored physiological condition of the patient; and

a processor operably connected to said patient health monitor and said drug delivery device;

said processor having accessible parameters that indicate values for said measurements of said monitored physiological condition, said values correlating to a range of patient conditions associated with said procedure; and

wherein said processor operates according to software to receive said signal during said procedure, analyze said measurements reflected in said signal using said parameters to identify onset or possible onset of a patient condition outside of a normal range, and generate a signal indicating possible modifications of said drug dosage rate to remedy said onset or possible onset of said patient condition, wherein said processor signal indicates an action dependent upon an extent by which said current measurements are outside said normal range.

2. The device as recited in claim 1, further comprising a fail safe system adapted to ensure proper operation of said device.

3. The device as recited in claim 1, wherein said processor employs an algorithm conforming to target-controlled infusion rates for controlling said drug delivery mechanism.

4. The device as recited in claim 1, wherein said patient health monitor is adapted to generate measurements reflecting effective spontaneous ventilation of the patient.

5. The device as recited in claim 1, wherein said patient health monitor comprises a brain activity monitor.

6. The device as recited in claim 1, wherein said patient health monitor is adapted to monitor a patient'"'"'s end tidal carbon dioxide levels in an exhaled air stream of the patient.

7. The device as recited in claim 1, wherein said patient health monitor device comprises a capnometer.

8. The device as recited in claim 1, wherein said processor receives said signal during said procedure and identifies any onsets or possible onsets of patient condition episodes outside of a desired range through said comparison, and wherein said processor modifies said supply rate if necessary to remedy said episode.

9. The device as recited in claim 1, wherein said drug delivery mechanism includes means for delivering said sedative intravenously.

10. The device as recited in claim 1, wherein said parameters indicate values for said measurements of said monitored physiological condition that reflect the onset of potentially undesirable patient conditions during said procedure.

11. The device as recited in claim 10, wherein said parameters indicate values for said measurements of said monitored physiological condition that reflect the onset of potentially unsafe patient conditions during said procedure.

12. The device as recited in claim 1, further comprising a second health monitor adapted to be coupled to a patient and generate a second signal reflecting second measurements of a second physiological condition of the patient;

and wherein said processor further contains second parameters indicating second values for said second measurements of said second physiological condition where said processor operates to receive said second signal, compare said second measurements reflected in said received second signal with said second parameters, and modify said dosage rate in response to said signal and said second signal as necessary to maintain safe and effective sedation during said procedure.

13. The device as recited in claim 1, wherein said drug delivery mechanism is electronically controllable to provide drug delivery according to infusion types selected from the group consisting of continuous infusion, target controlled intravenous infusion, bolus infusion, and combinations thereof.

14. The device as recited in claim 1, further comprising a recording means that creates records regarding patient conditions during said procedure.

15. The device as recited in claim 14, wherein said records created by said recording means further include drug usage data during said procedure.

16. The device as recited in claim 1, further comprising a manual input mechanism for permitting personnel performing the procedure to manually alter delivery of the sedative.

17. The device as recited in claim 16, wherein said input mechanism permits said personnel performing the procedure to increase a current dosage rate of drug delivery.

18. The device as recited in claim 17, wherein said values define a preset normal range of measurements of said monitored physiological condition for a patient undergoing said procedure, and wherein said processor controls said drug delivery mechanism by changing a drug dosage rate as necessary to maintain safe and effective sedation during said procedure.

19. The device as recited in claim 18, wherein said preset normal range is identified by at least one threshold for said measurements.

20. The device as recited in claim 19, wherein said values define at least two thresholds concerning said physiological condition, wherein said thresholds designate different levels of concern for said patient when said measurements move outside of said preset normal range.

21. The device as recited in claim 1, wherein said values define a preset normal range of measurements of said monitored physiological condition for a patient undergoing said procedure, said preset normal range of measurements corresponding to potential physiological conditions of a patient that is receiving propofol by continuous intravenous infusion.

22. The device as recited in claim 1, further including at least one alarm that is raised when said signal is determined to fall outside of said values correlating to safe and effective patient sedation during said procedure.

23. The device as recited in claim 22, wherein said processor curtails drug delivery upon the raising of said alarm if an unsafe patient condition is identified.

24. The device as recited in claim 22, wherein said processor increases the delivery of oxygen to the patient upon the raising of said alarm.

25. The device as recited in claim 22, wherein said alarm is adapted to produce alarms of multiple urgency levels as defined by said parameters.

26. The device as recited in claim 22, wherein said system also includes a display with an alarm box portion which displays a representation of the patient physiological condition associated with the raised alarm.

27. The device as recited in claim 26, wherein said monitored physiological condition is selected from the group consisting of a brain activity, heart rate, blood saturation, expired carbon dioxide, ventilation, and patient consciousness level.

28. The device as recited in claim 1, further comprising at least one system state monitor which generates a signal reflecting the state of at least one operating condition of the device and which is coupled to the processor;

and wherein said processor has access to parameters indicating one or more operating conditions of the device.

29. The device as recited in claim 28, wherein said system state monitor is an oxygen source pressure sensor that measures the flow of oxygen to the patient.

30. The device as recited in claim 28, wherein said system state monitor indicates whether there has been a power failure in the device.

31. The device as recited in claim 28, wherein said processor activates an attention-commanding device in response to said signal reflecting the state of at least one operating condition of the device.

32. The device as recited in claim 28, wherein said system state monitor is a drug source flow sensor that measures flow of drug to the patient.

33. The device as recited in claim 1, wherein said signal causes a communication device to raise an alarm regarding the condition of said patient, said alarm suggesting said possible modifications.

34. The device as recited in claim 33, wherein said possible modifications include a default action to be taken by said drug delivery mechanism, wherein said default action is performed by said drug delivery mechanism in the absence of contrary instructions from medical personnel within a time period after said alarm is raised.

35. The device as recited in claim 34, wherein said default action comprises said drug delivery mechanism device decreasing said drug dosage rate.

36. A device for providing sedation to a patient during a medical and/or surgical procedure, said device comprising:

an electronic drug delivery device adapted to be coupled to said patient and deliver to said patient one or more drugs at a drug delivery rate to provide sedation;

a monitor adapted to be coupled to the patient and provide feedback indicative of at least one monitored physiological condition of the patient;

a processor connected to said monitor, said processor receiving said feedback from said monitor and comparing said feedback to parameters that define whether a given patient is experiencing or in danger of experiencing an undesirable patient condition while receiving said drug at said drug delivery rate, and said processor thereby generating a signal reflecting the monitored physiological condition of the patient and indicating modifications of said drug delivery to avoid said undesirable patient condition during said medical procedure.

37. The device as recited in claim 36, wherein said processor is further adapted to communicate an alarm to said medical personnel in response to said signal, said alarm indicating that a possible modification of said drug delivery may need to occur to avoid said undesirable patient condition.

38. The device as recited in claim 37, wherein said electronic drug delivery device allows manual altering of delivery of drug by medical personnel in response to said feedbacks.

39. The device as recited in claim 37, wherein said processor is further adapted to communicate an alarm to said medical personnel in response to said signal, said alarm indicating that a possible modification of said drug delivery may need to occur to remedy an undesirable patient condition.

40. The device as recited in claim 37, wherein said alarm alerts a medical personnel of possible therapeutic options;

said therapeutic options being identified by said comparison.

41. The device as recited in claim 36, wherein said monitor is selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer, a blood pressure monitor and a patient consciousness monitor.

42. The device as recited in claim 36, wherein said parameters define a preset normal range of said feedback for a patient undergoing said procedure, and wherein said modifications of drug delivery comprises decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

43. The device as recited in claim 42, wherein said preset normal range is identified by at least one threshold for said feedback.

44. The device as recited in claim 43, wherein said parameters define at least two thresholds concerning said feedback, and wherein said thresholds designate different levels of concern for said patient when said feedback is outside of said preset normal range.

45. The device as recited in claim 36, wherein delivering of the drugs is accomplished by target-controlled infusion.

46. The device as recited in claim 36, wherein said monitor is a brain activity monitor and said controlling of said drug delivery device comprises causing said drug delivery device to modify a supply rate of drug automatedly in response to said signal.

47. The device as recited in claim 36, wherein said monitor is a pulse oximeter and said controlling of said drug delivery device comprises causing said drug delivery device to modify a supply rate of drug in response to changes in a monitored blood oxygen level of the patient.

48. The device as recited in claim 36, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

49. The device as recited in claim 36, wherein said monitor is a blood pressure monitor.

50. The device as recited in claim 36, further comprising means for creating a record detailing control of said drug delivery during said procedure.

51. The device as recited in claim 50, wherein said record further details information regarding said monitored physiological condition.

52. The device as recited in claim 50, wherein said record further details alarms generated in response to said signal.

53. The device as recited in claim 36, wherein said drug delivery device is adapted to perform a delivery mechanism selected from the group consisting of continuous infusion, target controlled infusion, bolus infusion, and combinations thereof.

54. The device as recited in claim 36, wherein said processor further receives a second signal reflecting a state of at least one operating condition of said drug delivery device or said monitor, said signal being received by said processor, and said processor thereby initiating alarms if said operating condition is unsatisfactory.

55. The device as recited in claim 54, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

56. The device as recited in claim 36, wherein said monitored physiological condition is the patient'"'"'s level of consciousness.

57. A device for sedating a patient undergoing one or more medical and/or surgical procedures, said device comprising:

a drug delivery device adapted to be connected to a patient and capable of controllable drug delivery to the patient during a procedure;

an electronic controller coupled to said drug delivery device, said controller adapted to control the delivery of drugs by said drug delivery device;

a patient health monitor device to a patient, said health monitor device generating a signal reflecting at least one monitored physiological condition of the patient, said signal being sent from said health monitor device to said electronic controller to communicate a current measurement reflecting said monitored physiological condition of the patient; and

wherein said electronic controller accesses parameters for said monitored physiological condition, said parameters including values for said measurements of said monitored physiological condition where said values correlate to safe and effective sedation during said procedure, said electronic controller compares said measurement reflected in said received signal with said parameters, and said electronic controller modifies a supply rate of the drugs according to software to maintain safe and effective sedation of the patient during said procedure, said electronic controller modifying said supply rate to an extent being dependent upon a second extent by which said measurement is outside one or more ranges defined by said parameters.

58. The device as recited in claim 57, wherein said patient health monitor device is selected from the group consisting of an electrocardiograph, a pulse oximeter, a brain activity monitor, a capnometer, a blood pressure monitor and a patient consciousness monitor.

59. The device as recited in claim 57, wherein said one of said ranges is defined by values that establish a preset normal range of said measurements for a patient undergoing said procedure, and wherein said modifying of said drug delivery rate comprises said electronic controller decreasing a current drug delivery rate or raising an alarm if said monitored physiological condition of the patient moves outside of said preset normal range.

60. The device as recited in claim 59, wherein said preset normal range is identified by at least one threshold for said measurements.

61. The device as recited in claim 60, wherein said values establish at least two thresholds concerning said physiological condition, and wherein said thresholds designate different levels of concern for said patient when measurements are outside of said preset normal range.

62. The device as recited in claim 57, wherein said values define measurements of said monitored physiological condition that evidence the onset of potentially undesirable patient conditions during said procedure.

63. The device as recited in claim 57, wherein said electronic controller modifies said supply rate according to a target-controlled infusion algorithm.

64. The device as recited in claim 57, wherein said patient health monitor device is a brain activity monitor and said modifying of said supply rate of drug is in response to a concentration of drug in the patient.

65. The device as recited in claim 57, wherein said patient health monitor device is a pulse oximeter and the modifying of said supply rate of the drug is in response to changes in a monitored blood oxygen level of the patient.

66. The device as recited in claim 57, wherein said monitored physiological condition is effective spontaneous ventilation of the patient.

67. The device as recited in claim 57, wherein said monitor device is a blood pressure monitor.

68. The device as recited in claim 57, further comprising means for creating a record detailing delivering of said drug during said one or more procedures.

69. The device as recited in claim 68, wherein said record further details information regarding said monitored physiological condition.

70. The device as recited in claim 57, wherein said drug delivery device is further adapted to permit manual altering the delivery of drug.

71. The device as recited in claim 70, wherein said manual altering comprises increasing a current rate of drug delivery to the patient.

72. The device as recited in claim 57, wherein said electronic controller receives a signal reflecting a state of at least one operating condition of said drug delivery device or said patient health monitor device, and said controller is adapted to initiate alarms if said operating condition is unsatisfactory.

73. The device as recited in claim 72, wherein said operating conditions are of types selected from the group consisting of oxygen flow status, power failures, and drug flow status.

74. The device as recited in claim 57, wherein said monitored physiological condition is the patient'"'"'s level of responsiveness.