Medication injection site and data collection system

• US 8,394,053 B2
• Filed: 11/06/2009
• Issued: 03/12/2013
• 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
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/614,276
• Publication Number:
  US 20110112473A1
• Time in Patent Office: 1,222 Days
• Field of Search: 128/203.12, 128/204.18, 361/724, 455/556.1, 600/301, 600/323, 600/485, 600/523, 600/532, 604 65- 68, 604/93.01, 604151-155, 604/404, 702/50, 702/188
• US Class Current: 604/93.01
• 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 injection site is provided that includes a medication port and an identification sensor. The medication injection site, when coupled to a medication container, can wirelessly transmit data characterizing the contents of the medication container to a remote data collection system. The housing of the medication injection site has a shape and size enabling it to be held by a first hand of a user while the user administers medication from the medication container via the medication port using his or her second hand. In some implementations, the medication injection site can be placed on an IV drip line. Related apparatus, systems, and kits are also disclosed.

Claims

1. A system comprising:

a housing;

a junction element at least partially extending within the housing forming 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;

a medication port extending from an external face of the housing that is fluidically and directly coupled to the distal end of the second fluid channel of the junction element, the medication port configured to be fluidically coupled to a fluid outlet of a medication container;

an identification sensor disposed within the housing to generate information indicative of contents of the medication container when the fluid outlet of the medication container is being fluidically coupled to the medication port;

a transmitter disposed within the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system; and

a self-contained power source disposed within the housing powering the identification sensor and the transmitter,

wherein;

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

2. A system as in claim 1, wherein a largest dimension of the housing is less than or equal to 10 centimeters.

3. A system as in claim 1, wherein a weight of the system is less than or equal to 500 grams.

4. A system as in claim 1, wherein the first end of the first fluid channel is fluidically coupled to tubing extending to a fluid source.

5. A system as in claim 4, wherein the fluid source is suspended and fluid contained therein is gravity fed via the tubing into the first channel, and wherein the housing is suspended below the fluid source and supported by the tubing during use.

6. A system as in claim 5, wherein the second end of the first fluid channel is fluidically coupled to a patient such that medication administered via the medication port is immediately delivered to the patient.

7. A system as in claim 1, further comprising:

a self-contained fluid delivery sensor disposed within the housing and in communication with the transmitter to characterize fluid flow through one or more of the first fluid channel and the second fluid channel, wherein the transmitter further wirelessly transmits data characterizing fluid delivery to the remote data collection system.

8. A system as in claim 7, wherein the fluid delivery sensor measures fluid flow and/or pressure in the first fluid channel.

9. A system as in claim 7, wherein the fluid delivery sensor measures fluid flow and/or pressure in the second fluid channel.

10. A system as in claim 7, wherein the fluid delivery sensor is either a pressure sensor, a differential pressure sensor or a fluid flow sensor.

11. A system as in claim 7, wherein the junction element contains a diaphragm portion along one or more of the first fluid channel and the second fluid channel, and the fluid delivery sensor is positioned adjacent to the diaphragm.

12. A system as in claim 7, wherein the remote data collection system calculates volume of fluid delivered via the medication port based on the wireless transmitted data characterizing fluid delivery.

13. A system as in claim 7, further comprising:

a self-contained power source disposed within the housing and powering at least one of the identification sensor, the fluid delivery sensor, and the transmitter.

14. A system as in claim 1, wherein an intersection of the first fluid channel and the second fluid channel forms a substantially T-shaped junction.

15. A system as in claim 1, wherein an intersection of the first fluid channel and the second fluid channel forms a substantially Y-shaped junction.

16. A system as in claim 1, wherein the medication port defines a cavity extending inwardly from an outer surface of the housing such that the fluid outlet of the medication container is substantially enveloped within the housing and does not extend beyond the outer surface when such fluid outlet is mechanically coupled to the port.

17. A system as in claim 1, further comprising the medication container, wherein the medication container bears an information source characterizing contents of the medication container.

18. A system as in claim 17, wherein the information source is selected from a group comprising:

mechanically encoded information, magnetically encoded information, and a radio frequency readable information.

19. A system as in claim 17, wherein the information source comprises optically encoded information, and the identification sensor comprises an optical emitter and an optical detector to read the optically encoded information.

20. A system as in claim 17, wherein the identification sensor reads information from the information source as a result of relative motion of the fluid outlet relative to the medication port.

21. A system as in claim 17, wherein the identification sensor reads information from the information source in response to mechanically coupling the fluid outlet to the medication port.

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

23. A system as in claim 1, wherein the junction element is a unitary injection molded fitting.

24. A system as in claim 1, wherein medication is intermittently delivered through the medication port and fluid is substantially continuously delivered to the first fluid channel via the first end of the first fluid channel.

25. A system as in claim 1, further comprising a first check valve disposed within the first fluid channel intermediate the intersection and the first end of the first fluid channel to prevent fluid delivered into the medication port from exiting the first fluid channel at the first end.

26. A system as in claim 1, further comprising a second check valve disposed within the secondary fluid channel to prevent fluid entering the first fluid channel at the first end from exiting the secondary fluid channel at the distal end.

27. A system as in claim 1, wherein the housing comprises a plurality of sections, and one or more of the first fluid channel and the second channel being formed when at least two of the sections are assembled.

28. A system as in claim 25, wherein at least two of the sections of the housing are injection molded and one or more of the first fluid channel and the second fluid channel is formed by one or more injection molded sections.

29. A system as in claim 1, further comprising a removable sterility cap affixed to the medication port.

30. A system as in claim 29, wherein removal of the sterility cap initiates communications between the transmitter and the remote data collection system.

31. A system as in claim 29, further comprising a self-contained power source disposed within the housing powering the identification sensor and the transmitter, and wherein removal of the sterility cap initiates provision of electricity by the power source to the identification sensor and the transmitter.

32. A system as in claim 1, wherein the shape and size of the housing further enables positioning of the housing on arm of a patient adjacent to an injection site on the patient.

33. A system as in claim 1, wherein the medication port is disposed within, partially within or extending outside the housing.

34. A system as in claim 1, wherein the medication port is integrated into the junction element.

35. A system as in claim 1, further comprising a memory element disposed within the housing, the memory element storing information obtained from the identification sensor.

36. A system as in claim 35, further comprising a timing element coupled to the memory element to enable recordation of events corresponding to time of medication administration, duration of medication administration, and time of wireless transmission of information generated by the identification sensor.

37. A system as in claim 36, wherein the remote data collection system wirelessly requests the transmitter to send information stored in the memory element obtained from the identification sensor.

38. A system as in claim 1, wherein the remote data collection system comprises a timing element to assign clock times to each data record based on absolute time and duration between recorded transmissions.

39. A system as in claim 1, wherein the system includes an identifier to uniquely identify wireless transmissions from the transmitter.

40. A kit comprising a sterile pouch enveloping the system according to claim 1.

44. A system as in claim 1, wherein the medication container comprises:

a barrel portion,

a fluid outlet tip,

a tapered portion intermediate the barrel portion and the fluid outlet tip,

an identification member having an opening larger than a diameter of the fluid outlet tip and smaller than or equal to the diameter of the barrel portion, the identification member containing optical, magnetic, radio frequency, and/or mechanically encoded information, the encoded information being indicative of one or more of the contents of the medication container, the volume of fluid within the medication container, and the expiration date of the contents of the medication container,

the encoded information being readable by the identification sensor when the identification member is located around the fluid outlet tip and the medication container is coupled or in process of being coupled to the medication port.

45. A system as in claim 44, wherein the identification member is disposed radially about a central fluid outlet axis of the fluid outlet tip enabling detection of the encoded information when the medication container is rotated about the central fluid outlet axis.

46. A system as in claim 44, wherein the encoded information is disposed linearly enabling detection of the information when the medication container is joined with a fluid pathway along a central fluid outlet axis of the medication container.

47. A system as in claim 44, wherein the medication container is a first medication container and the identification member is releasably secured to the first medication container allowing it to be removed for placement on a second medication container.

48. A system as in claim 47, wherein the identification member bears an attachment element allowing it to be removed from the first medication container and affixed to the second medication container.

49. A system as in claim 47, wherein transfer of the identification member from the first medication container to the second medication container is completed during the process of transferring the medication from the first medication container to the second medication container.

50. A system as in claim 47, wherein the identification member is a label adhered to the first medication container.

51. A system as in claim 47, wherein the identification member is integral to the first medication container.

52. A system as in claim 47, wherein the identification member is a ring shaped member configured to fit around the fluid outlet tip.

53. A system as in claim 17, wherein the information source characterizing the contents of the medication container comprises raw data specifying one or more traits which can be associated with the contents of the medication container by the remote data collection system.

41. A system comprising:

a housing;

a junction element at least partially extending within the housing forming 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;

a medication port extending from an external face of the housing that is fluidically and directly coupled to the distal end of the second fluid channel of the junction element, the medication port configured to be fluidically coupled to a fluid outlet of a medication container;

an identification sensor disposed adjacent to the second fluid channel to generate information indicative of contents of the medication container when the fluid outlet of the medication container is being fluidically coupled to the medication port;

a transmitter disposed within the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system; and

a self-contained power source disposed within the housing powering the identification sensor and the transmitter.

42. A system as in claim 41, further comprising:

a self-contained fluid delivery sensor disposed within the housing and in communication with the transmitter to characterize fluid flow through one or more of the first fluid channel and the second fluid channel, wherein the transmitter further wirelessly transmits data characterizing fluid delivery to the remote data collection system.

43. A medication injection site comprising:

a housing;

a medication port extending from an outer surface of the housing to couple to a fluid outlet of a manually injectable medication container, the medication port being fluidically coupled to a patient such that medication received via the medication port is immediately administered to the patient;

an identification sensor disposed within the housing to automatically generate information indicative of contents of the medication container during coupling of the fluid outlet of the medication container to the medication port; and

a transmitter disposed within the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system;

wherein the housing having a shape and size enabling it to be held by a first hand of a user while the user administers medication from the medication container via the medication port using his or her second hand.

54. An apparatus comprising:

a housing;

a medication port extending from an outer surface of the housing to couple to a fluid outlet of a manually injectable medication container, the medication port being fluidically coupled to a patient such that medication received via the medication port is immediately administered to the patient, the medication container having encoded information adjacent to the fluid outlet;

an identification sensor disposed within the housing adjacent to the medication port to automatically generate information indicative of contents of the medication container by detecting the encoded information during coupling of the fluid outlet of the medication container to the medication port; and

a transmitter disposed within the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system;

wherein the housing having a shape and size enabling it to be held by a first hand of a user while the user administers medication from the manually injectable medication container via the medication port using his or her second hand.

55. An apparatus as in claim 54, wherein the encoded information is selected from a group consisting of:

optically encoded information, magnetically encoded information, radio frequency detectable information, and mechanically detectable information.

56. An apparatus as in claim 54, further comprising:

at least one data processor disposed within the housing; and

a memory element disposed within the housing and coupled to the at least one data processor, the memory element storing mapping data that the at least one data processor accesses to associate data generated by the identification sensor with one or more of;

an identification of the patient,

an identification of the apparatus,

a serial number of the apparatus,

an identification of the medication container,

contents of the medication container,

a name of medication in the medication container,

a concentration of medication in the medication container,

a volume of the medication container, and

an expiration date of the contents of medication container.

57. An apparatus as in claim 54, further comprising:

a self-contained fluid delivery sensor disposed within the housing and in communication with the transmitter to characterize fluid flow through one or more of the first fluid channel and the second fluid channel, wherein the transmitter further wirelessly transmits data characterizing fluid delivery to the remote data collection system;

at least one data processor disposed within the housing; and

a memory element disposed within the housing and coupled to the at least one data processor, the memory element storing mapping data that the at least one data processor accesses to associate data generated by the fluid delivery sensor with one or more of;

an identification of the patient,

an identification of the apparatus,

a serial number of the apparatus,

flow or volume of fluid administered

time of fluid administration.