Medication injection site and data collection system

• US 8,385,972 B2
• Filed: 11/02/2010
• Issued: 02/26/2013
• Est. Priority Date: 11/06/2009
• Status: Active Grant

• Current Assignee: CRISI Medical Systems, Inc. (Becton, Dickinson & Co)
• Original Assignee: CRISI Medical Systems, Inc. (Becton, Dickinson & Co)
• Inventors: Bochenko, Walter John, DeKalb, Shawn Wayne, De Childers, Winthrop, Prince, Stephen Michael
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/938,300
• Publication Number:
  US 20110112474A1
• Time in Patent Office: 847 Days
• Field of Search: 455/556.1, 604 65- 68, 604/93.01, 604151-155, 604/404, 607/5
• US Class Current: 455/556.1
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 39/02 Access sites

Abstract

A medication delivery apparatus for use with a medication container includes a housing, a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient, a medication port extending from the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically coupled to the fluid conduit, and at least one sensor disposed within the housing to generate information characterizing administration of the medication for processing by a remote data collection system. The housing can have a size and shape that enables it to be supported by a first hand of a user while the user administers the medication from the medication container via the medication port using a second hand of the user. Related apparatus, systems, and techniques are also described.

Claims

1. A medication delivery apparatus for use with a medication container comprising:

a housing;

a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient via a parenteral fluid administration pathway;

a medication port extending from an external surface of the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically and directly coupled to the fluid conduit; and

at least one first sensor disposed within the housing to generate information characterizing administration of the medication for processing by a remote data collection system;

wherein the housing has a size and shape enabling it to be supported by a first hand of a user while the user administers the medication from the medication container via the medication port using a second hand of the user.

2. A medication delivery apparatus as in claim 1, further comprising:

at least one second sensor disposed within the housing to generate complementary information for processing by the remote data collection system.

3. A medication delivery apparatus as in claim 2, wherein the complementary information comprises encoded information.

4. A medication delivery apparatus as in claim 3, wherein the remote data collection system associates the information generated by the at least one sensor and/or the complementary information generated by the at least one second sensor with one or more of:

medication information, patient identification, patient weight, patient sex, patient age, patient Broselow color, pre-existing and/or current patient medical conditions, patient sample, medical device being used by the patient, caregiver name, caregiver photograph, caregiver ID, caregiver employer, a pharmacy record, pharmacy administration instructions, physicians orders.

5. A medication delivery apparatus as in claim 1, wherein tubing between the fluid conduit and a parenteral access device is 10 cm or less.

6. A medication delivery apparatus as in claim 1, wherein the fluid outlet is configured to directly inject medication into a patient through a needle or other patient access device.

7. A medication delivery apparatus as in claim 1, wherein the fluid outlet is configured to couple to an injection Y-site.

8. A medication delivery apparatus as in claim 1, further comprising:

a transmitter within the housing to transmit information generated by the at least one sensor to the remote data collection system; and

a self-contained power source within the housing powering the at least one first sensor and the transmitter.

9. A medication delivery apparatus as in claim 8, wherein the remote data collection system receives information wirelessly from the transmitter.

10. A medication delivery apparatus as in claim 1, wherein the housing comprises a reusable sub-housing and a disposable sub-housing, the disposable sub-housing being used by a single patient and including at least the fluid conduit and the medication port, the reusable sub-housing being used by a plurality of patients and including the at least one first sensor.

11. A medication delivery apparatus as in claim 10, wherein the re-usable sub-housing is operatively coupled to the disposable sub-housing by a connection interface including one or more of an electrical contact, an RF coupling, an optical coupling, a hydraulic coupling, a mechanical coupling, and a magnetic coupling.

12. A medication delivery apparatus as in claim 1, wherein the fluid conduit includes a first fluid channel and a second fluid channel, the first fluid channel extending from a first end to a second end, the second fluid channel extending from a distal end and terminating at the first fluid channel at an intersection intermediate the first end and the second end.

13. A medication delivery apparatus as in claim 1, wherein the fluid conduit is coupled to a fluid tubing set;

and/or

wherein the medication delivery apparatus is integral to and/or configured to be suspended below a fluid source.

14. A medication delivery apparatus as in claim 1, wherein the at least one first sensor includes an identification sensor and the medication container includes an information source, wherein the identification sensor reads the information from the information source.

15. A medication delivery apparatus as in claim 14, wherein the information source is disposed proximate to the fluid outlet of the medication container.

16. A medication delivery apparatus as in claim 15, wherein the information source is disposed upon a cylindrical or annular surface that is concentric to the fluid outlet of the medication container and the sensor generates the information characterizing administration of the medication when the medication container is coupled and/or being coupled to the medication port.

17. A medication delivery apparatus as in claim 1, wherein the at least one first sensor includes a fluid flow sensor and wherein the information includes information indicative of an amount of fluid delivered from the medication container to the patient.

18. A medication delivery apparatus as in claim 1, wherein the at least one first sensor includes a medication composition type sensor, and wherein the information includes information characterizing the composition of the medication.

19. A medication delivery apparatus as in claim 1, wherein the remote data collection system receives, transmits, integrates and/or reports information from and/or to a medical information source selected from a group comprising:

a medical device, and a medical information system.

20. A medication delivery apparatus as in claim 1, wherein the remote data collection system provides real-time information to a user including medication information, medical data specific to a patient, procedural instructions and/or protocols for patient treatment.

21. A medication delivery apparatus as in claim 18, wherein the remote data collection system provides a rule set defining conditions to alert and/or guide a caregiver using the apparatus.

22. A medication delivery apparatus as in claim 1, wherein the medication container is a needle-less syringe and the fluid outlet of the medication container is a tip of the syringe.

23. A medication delivery apparatus as in claim 1, further comprising:

a memory element disposed within the housing for storing information generated by the at least one first sensor.

24. A medication delivery apparatus as claim 1, further comprising:

an indicator element disposed within the housing for indicating the operational state of the medication delivery apparatus and/or illuminating the medication port providing user information.

25. A kit comprising a sterile pouch enveloping a medication delivery apparatus as in claim 1, wherein the medication delivery apparatus is provided within the pouch in a sterile condition.

78. A medication delivery apparatus as in claim 2, wherein the complementary information characterizes one or more of:

medication information, medication administration instructions, caregiver information, patient information, medical devices being used by the patient, and physician orders.

79. A medication delivery apparatus as in claim 78, wherein the medication information comprises one or more of:

type of medication, concentration of medication, volume of medication, and expiration date for medication.

26. A medication delivery apparatus for use with a medication container comprising:

a housing;

a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient;

a medication port extending from an external surface of the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically and directly coupled to the fluid conduit;

at least one sensor disposed within the housing to generate information characterizing administration of the medication;

a transmitter within the housing to wirelessly transmit information generated by the sensor to a remote data collection system; and

a self-contained power source within the housing powering the at least one sensor and the transmitter.

30. A medication delivery apparatus as in claim 26, further comprising:

at least one second sensor disposed within the housing to generate complementary information for processing by the remote data collection system.

31. A medication delivery apparatus as in claim 30, wherein the complementary information comprises encoded information.

32. A medication delivery apparatus as in claim 31, wherein the remote data collection system associates the information generated by the at least one sensor and/or the complementary information generated by the at least one second sensor with one or more of:

medication information, patient identification, patient weight, patient sex, patient age, patient Broselow color, pre-existing and/or current patient medical conditions, patient sample, medical device being used by the patient, caregiver name, caregiver photograph, caregiver ID, caregiver employer, a pharmacy record, pharmacy administration instructions, physicians orders.

33. A medication delivery apparatus as in claim 26, wherein the fluid outlet is configured to directly inject medication into a patient through a needle or other patient access device.

34. A medication delivery apparatus as in claim 26, wherein the fluid outlet is configured to couple to an injection Y-site.

35. A medication delivery apparatus as in claim 26, wherein the housing comprises a reusable sub-housing and a disposable sub-housing, the disposable sub-housing being used by a single patient and including at least the fluid conduit and the medication port, the reusable sub-housing being used by a plurality of patients and including the at least one sensor.

36. A medication delivery apparatus as in claim 35, wherein the re-usable sub-housing is operatively coupled to the disposable sub-housing by a connection interface including one or more of an electrical contact, an RF coupling, an optical coupling, a hydraulic coupling, a mechanical coupling, and a magnetic coupling.

37. A medication delivery apparatus as in claim 26, wherein the fluid conduit includes a first fluid channel and a second fluid channel, the first fluid channel extending from a first end to a second end, the second fluid channel extending from a distal end and terminating at the first fluid channel at an intersection intermediate the first end and the second end.

38. A medication delivery apparatus as in claim 26, wherein the fluid conduit is coupled to a fluid tubing set;

and/or

wherein the medication delivery apparatus is integral to and/or configured to be suspended below a fluid source.

39. A medication delivery apparatus as in claim 26, wherein the at least one sensor comprises an identification sensor and the medication container includes an information source, wherein the identification sensor reads the information from the information source.

40. A medication delivery apparatus as in claim 39, wherein the information source is disposed proximate to the fluid outlet of the medication container.

41. A medication delivery apparatus as in claim 40, wherein the information source is disposed upon a cylindrical or annular surface that is concentric to the fluid outlet of the medication container and the sensor generates the information characterizing administration of the medication when the medication container is coupled and/or being coupled to the medication port.

42. A medication delivery apparatus as in claim 26, wherein the at least one sensor includes a fluid flow sensor and wherein the information includes information indicative of an amount of fluid delivered from the medication container to the patient.

43. A medication delivery apparatus as in claim 26, wherein the at least one sensor comprises a medication composition type sensor, and wherein the information includes information characterizing the composition of the medication.

44. A medication delivery apparatus as in claim 26, wherein the remote data collection system receives, transmits, integrates and/or reports information from and/or to a medical information source selected from a group comprising:

a medical device, and a medical information system.

45. A medication delivery apparatus as in claim 26, wherein the remote data collection system provides real-time information to a user including medication information, medical data specific to a patient, procedural instructions and/or protocols for patient treatment.

46. A medication delivery apparatus as in claim 43, wherein the remote data collection system provides a rule set defining conditions to alert and/or guide a caregiver using the apparatus.

47. A medication delivery apparatus as in claim 26, wherein the medication container is a needle-less syringe and the fluid outlet of the medication container is a tip of the syringe.

48. A medication delivery apparatus as in claim 26, further comprising:

a memory element disposed within the housing for storing information generated by the at least one sensor.

49. A medication delivery apparatus as claim 26, further comprising:

an indicator element disposed within the housing for indicating the operational state of the medication delivery apparatus and/or illuminating the medication port providing user information.

50. A medication delivery apparatus as in claim 26, wherein the fluid conduit consists of a single inlet and a single outlet.

83. A medication delivery apparatus as in claim 30, wherein the complementary information characterizes one or more of:

medication information, medication administration instructions, caregiver information, patient information, medical devices being used by the patient, and physician orders.

84. A medication delivery apparatus as in claim 83, wherein the medication information comprises one or more of:

type of medication, concentration of medication, volume of medication, and expiration date for medication.

27. A medication delivery apparatus for use with a medication container comprising:

a housing;

a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient;

a medication port extending from an external surface of the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically and directly coupled to the fluid conduit;

at least two sensors disposed within the housing to generate information for processing by a remote data collection system, a first sensor characterizing administration of the medication through the fluid conduit, a second sensor characterizing information complementary to the administration of medication, the information complementary to the administration of medication selected from a group consisting of;

medication information, medication administration instructions, caregiver information, patient information, and medical devices being used by the patient;

a transmitter within the housing to wirelessly transmit information generated by the at least two sensors to a remote data collection system; and

a self-contained power source within the housing powering the at least one sensor and the transmitter.

51. A medication delivery apparatus as in claim 27, wherein the fluid conduit consists of a single inlet and a single outlet.

77. A medication delivery apparatus as in claim 27, wherein the fluid conduit consists of a single inlet and a single outlet.

28. A method for implementation by one or more data processors comprising:

receiving, by at least one data processor, information from a medication delivery apparatus characterizing administration of medication to a patient;

associating, by at least one data processor, the information with data specifying at least one medication and/or a volume of medication; and

promoting the associated data;

wherein the medication delivery apparatus comprises;

a housing;

a fluid conduit at least partially extending within the housing and configured to deliver medication within a medication container to the patient;

a medication port extending from an external surface of the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically and directly coupled to the fluid conduit;

at least one sensor disposed within the housing to generate information characterizing administration of the medication;

a transmitter within the housing to wirelessly transmit information generated by the at least one sensor to a remote data collection system; and

a self-contained power source within the housing powering the at least one sensor and the transmitter.

29. A method as in claim 28, wherein promoting the associated data comprises:

persisting the associated data, presenting the associated data in a display device, and/or transmitting the associated data to a remote computing system.

52. A method as in claim 28, wherein the housing of the medication delivery apparatus has a size and shape enabling it to be supported by a first hand of a user while the user administers the medication from the medication container via the medication port using a second hand of the user.

53. A method as in claim 28, wherein the medication delivery device further comprises:

at least one second sensor disposed within the housing to generate complementary information for processing by the remote data collection system.

54. A method as in claim 53, wherein the complementary information comprises encoded information.

55. A method as in claim 54, wherein the remote data collection system associates the information generated by the at least one sensor and/or the complementary information generated by the at least one second sensor with one or more of:

medication information, patient identification, patient weight, patient sex, patient age, patient Broselow color, pre-existing and/or current patient medical conditions, patient sample, medical device being used by the patient, caregiver name, caregiver photograph, caregiver ID, caregiver employer, a pharmacy record, pharmacy administration instructions, physicians orders.

56. A method as in claim 28, wherein the fluid conduit is coupled to the patient via a parenteral fluid administration pathway and wherein tubing between the fluid conduit and a parenteral access device is 10 cm or less.

57. A method as in claim 28, wherein the fluid outlet is configured to directly inject medication into a patient through a needle or other patient access device.

58. A method as in claim 28, wherein the fluid outlet is configured to couple to an injection Y-site.

59. A method as in claim 28, wherein the medication delivery apparatus further comprises:

a transmitter within the housing to transmit information generated by the sensor to the remote data collection system; and

a self-contained power source within the housing powering the at least one first sensor and the transmitter.

60. A method as in claim 59, wherein the remote data collection system receives information wirelessly from the transmitter.

61. A method as in claim 28, wherein the housing comprises a reusable sub-housing and a disposable sub-housing, the disposable sub-housing being used by a single patient and including at least the fluid conduit and the medication port, the reusable sub-housing being used by a plurality of patients and including the at least one sensor.

62. A method as in claim 28, wherein the re-usable sub-housing is operatively coupled to the disposable sub-housing by a connection interface including one or more of an electrical contact, an RF coupling, an optical coupling, a hydraulic coupling, a mechanical coupling, and a magnetic coupling.

63. A method as in claim 28, wherein the fluid conduit includes a first fluid channel and a second fluid channel, the first fluid channel extending from a first end to a second end, the second fluid channel extending from a distal end and terminating at the first fluid channel at an intersection intermediate the first end and the second end.

64. A method as in claim 28, wherein the fluid conduit is coupled to a fluid tubing set;

and/or

wherein the medication delivery apparatus is integral to and/or configured to be suspended below a fluid source.

65. A method as in claim 28, wherein the at least one sensor includes an identification sensor and the medication container includes an information source, wherein the identification sensor reads the information from the information source.

66. A method as in claim 65, wherein the information source is disposed proximate to the fluid outlet of the medication container.

67. A method as in claim 66, wherein the information source is disposed upon a cylindrical or annular surface that is concentric to the fluid outlet of the medication container and the sensor generates the information characterizing administration of the medication when the medication container is coupled and/or being coupled to the medication port.

68. A method as in claim 28, wherein the at least one sensor includes a fluid flow sensor and wherein the information includes information indicative of an amount of fluid delivered from the medication container to the patient.

69. A method as in claim 28, wherein the at least one sensor includes a medication composition type sensor, and wherein the information includes information characterizing the composition of the medication.

70. A method as in claim 28, wherein the remote data collection system receives, transmits, integrates and/or reports information from and/or to a medical information source selected from a group comprising:

a medical device, and a medical information system.

71. A method as in claim 28, wherein the remote data collection system provides real-time information to a user including medication information, medical data specific to a patient, procedural instructions and/or protocols for patient treatment.

72. A method as in claim 69, wherein the remote data collection system provides a rule set defining conditions to alert and/or guide a caregiver using the apparatus.

73. A method as in claim 28, wherein the medication container is a needle-less syringe and the fluid outlet of the medication container is a tip of the syringe.

74. A method as in claim 28, herein the medication delivery apparatus further comprises:

a memory element disposed within the housing for storing information generated by the at least one sensor.

75. A method as in claim 28, wherein the medication delivery apparatus further comprises:

an indicator element disposed within the housing for indicating the operational state of the medication delivery apparatus and/or illuminating the medication port providing user information.

76. A method as in claim 28, wherein the fluid conduit consists of a single inlet and a single outlet.

80. A method as in claim 28, wherein the complementary information characterizes one or more of:

medication information, medication administration instructions, caregiver information, patient information, medical devices being used by the patient, and physician orders.

81. A method as in claim 80, wherein the medication information comprises one or more of:

type of medication, concentration of medication, volume of medication, and expiration date for medication.

82. A medication delivery apparatus as in claim 81, wherein the medication information comprises one or more of:

type of medication, concentration of medication, volume of medication, and expiration date for medication.