System, process and diagnostic arrangement establishing and monitoring medication doses for patients

• US 20040260478A1
• Filed: 08/16/2004
• Published: 12/23/2004
• Est. Priority Date: 08/03/2001
• Status: Abandoned Application

• Current Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Schwamm, Lee H.
• Application Number:
  US10/486,171
• Publication Number:
  US 20040260478A1
• Time in Patent Office: Days
• US Class Current: 702/20
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A diagnostic device, process, system and software arrangement are provided for ascertaining particular information (e.g., medical dosage recommendation and/or therapeutic recommendation) related to a patient. In particular, a diagnostic device can receive previously-stored data associated with the patient from a remote device. Then, a test to ascertain the particular information based on the received previously-stored data can be performed on a biological property (e.g., a biological sample). The particular information may include a level of at least one measurement for the biological property, which may be a compound provided in the sample, with the sample containing a bodily fluid of the patient A web access processing arrangement can also be made available such that access to the respective patient associated with the particular information and a further user (e.g., the patient'"'"'s physician, nurse, relatives etc.) can be provided so that they can view the received particular information or add information to the system manually.

Claims

1. A diagnostic device for ascertaining particular information related to a patient, comprising:

a processing arrangement which is capable of;

i. receiving previously-stored data associated with the patient, and

ii. ordering a performance of a test on a biological property of the patient to ascertain the particular information based on the received previously-stored data, the particular information including at least one measurement of the biological property.

2. The diagnostic device according to claim 1, wherein the processing device is capable of transmitting the particular information to a remote device via a communication network.

3. The diagnostic device according to claim 2, wherein the processing arrangement makes an electronic request for the previously-stored data to be provided to the diagnostic device from the remote device via the communication network.

4. The diagnostic device according to claim 3, further comprising:

a communication arrangement connected to the processing arrangement,

wherein the processing arrangement transmits the request for the previously-stored data to the communication arrangement to be forwarded to the remote device via the communication network, and

wherein the communication arrangement receives the previously-stored data from the remote device to be accessed by the processing arrangement.

5. The diagnostic arrangement according to claim 1, wherein the processing arrangement is connected to an input device,

wherein, if the processing arrangement determines that the patient does not have previously-stored data associated therewith, the processing arrangement requests new data for the patient from the input device, and

wherein the processing arrangement receives at least one of manually-entered data or electronically-provided data for the patient from the input device.

6. The diagnostic device according to claim 1, further comprising:

a storage arrangement storing an executable code thereon, wherein the processing arrangement retrieves the executable code to perform the receiving and ordering operations.

7. The diagnostic device according to claim 6, wherein the executable code, when run by the processing device, executes a loading dosage procedure for the sample.

8. The diagnostic device according to claim 7, wherein the loading dosage procedure generates a recommended dosage of medication for the patient when an indication related to the at least one measurement and corresponding to the recommended dosage is within a predetermined threshold range, the recommended dosage being generated based on the previously-stored data and a result of the test.

9. The diagnostic device according to claim 8, wherein the recommended dosage of the medication for the patient is capable of being provided to a plurality of remote devices, and is capable of being modified by a care provider.

10. The diagnostic device according to claim 8, wherein the indication is an international normalized ratio (“

INR”

) for the sample of the patient.

11. The diagnostic device according to claim 10, wherein the processing arrangement transmits the generated INR and the corresponding recommended dosage for the patient to a remote device to be stored on a remote storage device as a portion of the previously-stored data of the patient.

12. The diagnostic device according to claim 10, wherein the processing arrangement stores the generated INR and the corresponding recommended dosage for the patient on the storage arrangement as a portion of the previously-stored data of the patient.

13. The diagnostic device according to claim 10,

wherein, if the processing arrangement determines that the generated INR of the patient is below a lowest value in a predetermined threshold range, the processing arrangement continues a periodic execution of the loading dosage procedure for the patient,

wherein, if the processing arrangement determines that the INR for the sample of the patient is above a highest value of the predetermined threshold range, an alert is generated to indicate a value of the INR, and

wherein, if the processing arrangement determines that the INR for the sample of the patient is in the predetermined threshold range, the recommended dosage of the medication corresponding to the INR for the sample of the patient is recorded to be utilized by a maintenance dosage procedure.

14. The diagnostic device according to claim 13, wherein the maintenance dosage procedure generates a maintenance INR for the sample of the patient based on the previously-stored data and the recommended dosage generated by the loading dosage procedure, wherein the maintenance INR corresponds to a maintenance dosage.

15. The diagnostic device according to claim 14, wherein the maintenance dosage of the medication for the patient is capable of being provided to a plurality of remote devices, and capable of being modified by a care provider.

16. The diagnostic device according to claim 14, further comprising:

an input device coupled to the processing arrangement, wherein a user is capable of modifying the maintenance dosage corresponding to the maintenance INR for the patient via the input device.

17. The diagnostic device according to claim 14, wherein the maintenance dosage procedure generates the maintenance dosage of the medication for the patient based on the previously-stored data and the INR for the patient generated by the loading dosage procedure.

18. The diagnostic device according to claim 17, wherein the maintenance dosage of the medication for the patient is capable of being provided to a plurality of remote devices.

19. The diagnostic device according to claim 17, wherein the processing arrangement initiates the maintenance dosage procedure after the INR for the patient generated by the loading dosage procedure reaches a value within the predetermined threshold.

20. The diagnostic device according to claim 14, wherein the processing arrangement transmits the maintenance INR and the corresponding maintenance dosage for the patient to a remote device to be stored on a remote storage device to be at least a portion of the previously-stored data of the patient.

21. The diagnostic device according to claim 14, wherein the processing arrangement stores the maintenance INR for the patient on the storage arrangement to be a portion of the previously-stored data of the patient.

22. The diagnostic device according to claim 14, wherein, if the processing arrangement determines that the maintenance INR for the patient is outside a predefined range, the processing arrangement modifies the maintenance dosage and re-executes the maintenance dosage procedure to determine if the maintenance INR corresponding to the modified dosage is within the predefined range.

23. The diagnostic device according to claim 14, further comprising:

an input device coupled to the processing arrangement, wherein a user is capable of modifying the maintenance INR for the patient via the input device.

24. The diagnostic device according to claim 1, wherein the biological property includes a bodily fluid of the patient, further comprising:

an insertion arrangement adapted to receive the bodily fluid, wherein, when the bodily fluid is received in the insertion arrangement, the assertion arrangement makes data, which corresponds to a composition and amounts of certain elements of the sample, available to the processing arrangement.

25. The diagnostic device according to claim 1, wherein the diagnostic device is a biosensing portable device.

26. The diagnostic device according to claim 25, wherein the portable device includes a personal digital assistant.

27. The diagnostic device according to claim 1, wherein the processing arrangement transmits the particular information to a web processing arrangement to be displayed on a web page associated with the patient, the web page being accessible by the patient via a secure connection.

28. A process for determining particular information associated with a patient, comprising the steps of:

a) receiving previously-stored data associated with the patient by a diagnostic device; and

b) with the diagnostic device, performing a test on a biological property of the patient to ascertain the particular information based on the received previously-stored data, the particular information including at least one measurement of the biological property.

29. The process according to claim 28, further comprising the step of:

c) transmitting the particular information to a remote device via a communication network.

30. The process according to claim 29, wherein the transmitting step includes the substep of generating an electronic request by the diagnostic device to the remote device for the previously-stored data to be provided from the remote device via the communication network.

31. The process according to claim 30, wherein step (a) further comprises the substep of forwarding, by the remote device, the previously-stored data from a storage arrangement to the diagnostic device.

32. The process according to claim 31, wherein the remote device is a central processing arrangement, and wherein the storage arrangement is a database connected to the central processing device.

33. The process according to claim 31, wherein the storage arrangement is a storage device connected to the diagnostic device.

34. The process according to claim 30, wherein step (a) further comprises the step of obtaining the previously-stored data by the diagnostic device from a storage arrangement directly connected to the diagnostic device.

35. The process according to claim 28, wherein the processing arrangement is connected to an input device, and further comprising the steps of:

d) if the patient does not have previously-stored data associated therewith, requesting new data for the patient from the input device; and

e) receiving at least one of manually-entered data or electronically-provided data for the new patient from the input device.

36. The process according to claim 28, wherein the diagnostic device includes a storage arrangement which stores an executable code thereon, and further comprising the step of:

f) retrieving the executable code to perform steps (a) and (b).

37. The process according to claim 36, further comprising the step of:

g) running the executable code to executes a loading dosage procedure for the sample.

38. The process according to claim 37, further comprising the step of:

h) generating, with the loading dosage procedure, a recommended dosage of medication for the patient when an indication associated with the at least one measurement and corresponding to the recommended dosage is within a predetermined threshold range, wherein the recommended dosage is generated based on the previously-stored data and a result of a test in step (b).

39. The process according to claim 38, further comprising the step of:

i) providing the recommended dosage of the medication for the patient to a plurality of remote devices, wherein the recommended dosage is capable of being modified by a care provider.

40. The process according to claim 39, wherein the remote devices include at least two of a physician'"'"'s processing device and a pharmacy'"'"'s processing device.

41. The process according to claim 40, further comprising the step of:

j) providing a capability for a physician to change the recommended dosage of the medication for the patient using at least one of the physician'"'"'s processing device and the diagnostic device.

42. The process according to claim 38, wherein the indication is an international normalized ratio (“

INR”

) for the sample of the patient.

43. The process according to claim 42, further comprising the step of:

k) transmitting the generated INR and the corresponding recommended dosage for the patient to a remote device to be stored on a remote storage device as a portion of the previously-stored data of the patient.

44. The process according to claim 37, further comprising the step of:

l) recording the generated INR and the corresponding recommended dosage for the patient on the storage arrangement as a portion of the previously-stored data of the patient.

45. The process according to claim 37, further comprising the steps of:

m) if the processing arrangement determines that the generated INR of the patient is below a lowest value in a predetermined threshold range, continuing a periodic execution of the loading dosage procedure for the patient;

n) if the processing arrangement determines that the INR for the sample of the patient is above a highest value of the predetermined threshold range, generating an alert to indicate a value of the INR; and

o) if the processing arrangement determines that the INR for the sample of the patient is in the predetermined threshold range, recording the recommended dosage of the medication corresponding to the INR for the sample of the patient to be utilized by a maintenance dosage procedure.

46. The process according to claim 45, further comprising the step of:

p) with the maintenance dosage procedure, generating a maintenance INR for the sample of the patient based on the previously-stored data and the recommended dosage generated by the loading dosage procedure, wherein the maintenance INR corresponds to a maintenance dosage.

47. The process according to claim 46, further comprising the step of:

q) with the maintenance dosage procedure, maintaining the maintenance dosage of the medication for the patient based on the previously-stored data and the INR for the patient generated by the loading dosage procedure.

48. The process according to claim 46, further comprising the step of:

r) providing the maintenance dosage of the medication for the patient to a plurality of remote devices.

49. The process according to claim 46, further comprising the step of:

s) providing an ability for a use to modify the maintenance INR for the patient via an input device.

50. The process according to claim 46, further comprising the step of:

t) providing the maintenance dosage of the medication for the patient to a plurality of remote devices.

51. The process according to claim 50, wherein the remote devices include at least two of a physician'"'"'s processing device and a pharmacy'"'"'s processing device.

52. The process according to claim 46, further comprising the step of:

u) initiating the maintenance dosage procedure after the INR for the patient generated by the loading dosage procedure is maintained reaches a value within the predetermined threshold.

53. The process according to claim 46, further comprising the step of:

v) transmitting the maintenance INR for the patient to a remote device to be stored on a remote storage device to be a portion of the previously-stored data of the patient.

54. The process according to claim 46, further comprising the step of:

w) recording the maintenance INR for the patient on a storage arrangement connected to a remote device to be a portion of the previously-stored data of the patient.

55. The process according to claim 46, further comprising the step of:

x) if the maintenance INR for the sample of the patient is outside a predefined range, modifying the maintenance dosage and re-executing the maintenance dosage to determine if the maintenance INR corresponding to the modified dosage is within the predefined range.

56. The process according to claim 46, wherein the diagnostic device is connected to an input device, wherein a user is capable of modifying the maintenance INR for the patient via the input device.

57. The process according to claim 28, wherein the biological property includes a bodily fluid of the patient, and wherein the diagnostic device is connected to an insertion arrangement which is adapted to receive the bodily fluid, and further comprising the step of:

y) when the bodily fluid is received in the insertion arrangement, availing data corresponding to a composition and amounts of certain elements of the sample.

58. The process according to claim 28, wherein the diagnostic device is a portable device.

59. The process according to claim 58, wherein the portable device includes a biosensing personal digital assistant.

60. The process according to claim 28, further comprising the step of:

y) transmitting the particular information to a web processing arrangement to be displayed on a web page associated with the patient, the web page being accessible by the patient via a secure connection.

61. A system for determining particular information associated with a patient, comprising:

a diagnostic device receiving the previously-stored data associated with the patient, the diagnostic device performing a test on a biological property of the patient to ascertain the particular information based on the received previously-stored data, the particular information including at least one measurement of the biological property.

62. The system according to claim 61, wherein the diagnostic device transmits the particular information to a remote device via a communication network.

63. The system according to claim 62, wherein the diagnostic device transmits an electronic request for the remote device to provide the previously-stored data via the communication network.

64. The system according to claim 63, wherein the remote device transmits the previously-stored data from a storage arrangement to the diagnostic device.

65. The system according to claim 64, wherein the remote device is a central processing arrangement, and wherein the storage arrangement is a database connected to the central processing device.

66. The system according to claim 64, wherein the storage arrangement is a storage device connected to the diagnostic device.

67. The system according to claim 63, wherein the diagnostic device obtains the previously-stored data from a storage arrangement which is directly connected to the diagnostic device.

68. The system according to claim 61,

wherein the processing arrangement is connected to an input device,

wherein, if the patient does not have previously-stored data associated therewith, the diagnostic device requests new data for the patient from the input device, and

wherein the diagnostic device receives at least one of manually-entered data or electronically-provided data for the patient from the input device.

69. The system according to claim 61, wherein the diagnostic device includes a storage arrangement which stores an executable code thereon, and a processing arrangement which retrieves the executable code for generating the particular information.

70. The system according to claim 69, wherein the processing arrangement of the diagnostic device runs the executable code to execute a loading dosage procedure for the sample.

71. The system according to claim 70, wherein the loading dosage procedure generates a recommended dosage of medication for the patient based on the previously-stored data and a result of the test.

72. The system according to claim 71, wherein the loading dosage procedure provides the recommended loading dosage of the medication for the patient to a plurality of remote devices.

73. The system according to claim 72, wherein the remote devices include at least two of a physician'"'"'s processing device and a pharmacy'"'"'s processing device.

74. The system according to claim 73, wherein a physician is capable of changing the recommended dosage of the medication for the patient using at least one of the physician'"'"'s processing device and the diagnostic device.

75. The system according to claim 70, wherein the loading dosage procedure generates an international normalized ratio (“

INR”

) for the sample of the patient based on the previously-stored data and a result of the test to provide the particular information.

76. The system according to claim 75, wherein the diagnostic device transmits the generated INR for the patient to a remote device to be stored on a remote storage device as a portion of the previously-stored data of the patient.

77. The system according to claim 75, wherein at least one of the diagnostic device and a remote device records the generated INR for the patient on the storage arrangement as a portion of the previously-stored data of the patient.

78. The system according to claim 75,

wherein, if at least one device of the diagnostic device and a remote device determine that the generated INR of the patient is below a lowest value in a predetermined threshold range, the at least one of the diagnostic device and the remote device continues a periodic execution of the loading dosage procedure for the patient,

wherein, if at least one device of the diagnostic device and the remote device determine that the INR for the sample of the patient is above a highest value of the predetermined threshold range, an alert is generated to indicate a value of the INR, and

wherein, if at least one device of the diagnostic device and the remote device determine that the INR for the sample of the patient is in the predetermined threshold range, the recommended dosage of the medication corresponding to the INR for the sample of the patient is recorded to be utilized by a maintenance dosage procedure.

79. The system according to claim 78, wherein the maintenance dosage procedure generates a maintenance INR for the sample of the patient based on the previously-stored data and the INR generated by the loading dosage procedure, and wherein the maintenance INR corresponds to a maintenance dosage.

80. The system according to claim 79, wherein the maintenance dosage procedure generates a maintenance dosage of the medication for the patient based on the previously-stored data and the INR for the patient generated by the loading dosage procedure.

81. The system according to claim 79, wherein the at least one device provides the maintenance dosage of the medication for the patient to a plurality of remote devices.

82. The system according to claim 79, wherein the at least one device allows for a modification of the maintenance INR for the patient via an input device.

83. The system according to claim 79, wherein the at least one device provides the maintenance dosage of the medication for the patient to a plurality of remote devices.

84. The system according to claim 83, wherein the remote devices include at least two of a physician'"'"'s processing device and a pharmacy'"'"'s processing device.

85. The system according to claim 79, wherein the at least one device initiates the maintenance dosage procedure after the INR for the patient generated by the loading dosage procedure reaches a value that is within the predetermined threshold.

86. The system according to claim 79, wherein the at least one device transmits the maintenance INR for the patient to the remote device to be stored on a remote storage device to be a portion of the previously-stored data of the patient.

87. The system according to claim 79, wherein the at least one device records the maintenance INR for the patient on a storage arrangement connected to the remote device to be a portion of the previously-stored data of the patient.

88. The system according to claim 79, wherein if the at least one device determines that the maintenance INR for the patient is outside a predefined range, the at least one device modifies the maintenance dosage and re-executes the maintenance dosage procedure to determine if the maintenance INR corresponding to the modified maintenance dosage is within the predefined range.

89. The system according to claim 79, wherein the diagnostic device is connected to an input device, wherein a user is capable of modifying the maintenance INR for the patient via the input device.

90. The system according to claim 61, wherein the diagnostic device is connected to an insertion arrangement which is adapted to receive the biological property which includes a bodily fluid of the patient, and wherein, when the bodily fluid is received in the insertion arrangement, the diagnostic device provides data corresponding to a composition and amounts of certain elements of the biological property.

91. The system according to claim 61, wherein the diagnostic device is a biosensing portable device.

92. The system according to claim 91, wherein the portable device includes a personal digital assistant.

93. The process according to claim 61, wherein at least one of the diagnostic device and the remote device transmit the particular information to a web processing arrangement to be displayed on a web page associated with the patient, the web page being accessible by the patient via a secure connection.

94. A web arrangement for providing particular information associated with patients, comprising:

a processing system capable of retrieving previously-stored data associated with the patient, and the particular information provided by at least one of a diagnostic device and a remote device,

wherein the particular information is determined by executing a test performed on a biological property using at least one of the diagnostic device and the remote device, the particular information being determined based on the received previously-stored data, the particular information including at least one measurement of the biological property, and

wherein the processing system provides access to at least one of the respective patient of the patients associated with the particular information and a further user to view the particular information.

95. The web arrangement according to claim 94, wherein the processing system is capable of providing a personal web page for each of the patients so that the particular information for each respective patient is displayed thereto, and prevents access of the particular information to other patients.

96. The web arrangement according to claim 94, wherein the further user includes at least one of a physician of the respective patient, a pharmacy of the respective patient, a nurse of the respective patient and a relative of the respective patient.

97. A software system which, when executed on a processor, is capable of communicating determining particular information associated with a patient, the software comprising:

a program which is capable of configuring the processor to;

a) prompt the diagnostic device to receive previously-stored data associated with the patient, and

b) perform a test on a biological property to ascertain the particular information of the patient based on the received previously-stored data, the particular information including at least one measurement of the biological property.

98. The software system according to claim 97, wherein the particular information includes at least one of a medication dosage recommendation and a therapeutic recommendation for the patient.

99. A diagnostic device for ascertaining particular information related to a patient, comprising:

a processing arrangement which is capable of;

i. receiving previously-stored data associated with the patient from a remote device, and

ii. ordering a performance of a test on a biological sample to ascertain the particular information based on the received previously-stored data, the particular information including a level of at least one compound provided in the sample, the sample containing a bodily fluid of the patient.

100. A process for communicating between a diagnostic device and a remote device and determining particular information associated with a patient, comprising the steps of:

a) receiving previously-stored data associated with the patient by diagnostic device from the remote device; and

b) with the diagnostic device, performing a biological test on a biological sample to ascertain the particular information based on the received previously-stored data, the particular information including a level of at least one compound provided in the sample, the sample containing a bodily fluid of the patient.

101. A system for determining particular information associated with a patient, comprising:

a remote device providing previously-stored data associated with the patient; and

a diagnostic device communicating with the central processing arrangement and receiving the previously-stored data associated with the patient the diagnostic device from the remote device, the diagnostic device performing a test on a biological sample to ascertain the particular information based on the received previously-stored data, the particular information including a level of at least one compound provided in the sample, the sample containing a bodily fluid of the patient.

102. A web arrangement for providing particular information associated with patients, comprising:

a processing system capable of retrieving previously-stored data associated with the patient, and the particular information provided by at least one of a diagnostic device and a remote device,

wherein the particular information is determined using a test performed on a biological sample by at least one of the diagnostic device and the remote device based on the received previously-stored data, the particular information including a level of at least one compound provided in the sample, the sample containing a bodily fluid of the patient, and

wherein the processing system provides access to at least one of the respective patient of the patients associated with the particular information and a further user to view the provided particular information.

103. A software system which, when executed on a processor, is capable of communicating between a diagnostic device and a remote device and determining particular information associated with a patient, the software comprising:

a program which is capable of configure the processor to;

a) prompt the diagnostic device to receive previously-stored data associated with the patient, and

b) perform a test on a biological sample to ascertain the particular information based on the received previously-stored data, the particular information including a level of at least one compound provided in the sample, the sample containing a bodily fluid of the patient.