Extended Use Medical Device

• US 20110054390A1
• Filed: 09/02/2009
• Published: 03/03/2011
• Est. Priority Date: 09/02/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Tunkel, Roman, Knapp, Keith N., Skutnik, Peter, Searle, Gary, Vedrine, Lionel
• Granted Patent: US 9,375,529 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 2205/16 with back-up system in case of failure
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3134 characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
• CPC Class Codes: A61M 5/385 using hydrophobic filters
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Provided is an extended use self-contained, wearable medical device. The device is preferably configured with an infusion deployment mechanism for variably inserting and retracting an infusion needle to different depths, or completely retracting the infusion needle from the infusion site and then re-inserting the infusion needle after a predetermined period of time, throughout an infusion cycle for extending the viability of the infusion site. Another embodiment comprises dual needle deployment mechanisms which may also variably insert and retract the infusion needles. A flow sensor is preferably provided for detecting the stoppage of flow through the infusion cannula and signaling the needle deployment mechanism to attempt infusion at a different depth or to deploy a second infusion needle. A re-fillable reservoir assembly is preferably provided for supplying a drug over the extended use of the device. Another embodiment comprises a partially reusable and partially disposable medical device implementing the above features.

Claims

1. A medical device for administering drug therapy to a user over an extended period of use, said medical device comprising:

a pump mechanism for administering a drug to the user;

first and second delivery cannulas for infusing said drug transdermally into the user at first and second infusion sites; and

first and second mechanisms for separately controlling deployment of the first and second cannulas into said user at said first and second infusion sites.

2. The medical device of claim 1, further comprising:

a flow sensing unit for detecting whether the first infusion site is no longer viable by sensing whether the first delivery cannula is blocked or otherwise incapable of delivering a desired flow of drug to the user.

3. The medical device of claim 2, wherein the first delivery cannula is retracted from the user when the flow sensing unit detects that the infusion site is no longer viable.

4. The medical device of claim 1, wherein the first delivery cannula is retracted from the user after a predetermined period of use.

5. The medical device of claim 1, wherein the second delivery cannula is deployed into the user when the first delivery cannula is retracted.

6. The medical device of claim 1, wherein the first and second mechanisms for controlling deployment of the first and second delivery cannulas are manually actuated.

7. The medical device of claim 1, wherein the first and second mechanisms for controlling the deployment of the first and second delivery cannulas are automatically actuated.

8. The medical device of claim 1, further comprising a reservoir supplying a volume of drug necessary for the extended duration of use of the medical device.

9. The medical device of claim 1, further comprising a first and second reservoir for supplying the drug to the respective first and second delivery cannulas.

10. The medical device of claim 1, further comprising a refillable reservoir supplying the drug infused into the user, said reservoir including a port or septum for receiving a supply of the drug.

11. The medical device of claim 1, further comprising a receptacle for receiving a pre-filled reservoir assembly.

12. The medical device of claim 1, wherein the pump mechanism and the first and second mechanisms for controlling deployment of the first and second cannulas are housed in a reusable portion of the medical device.

13. The medical device of claim 1, wherein the medical device is affixed to a user'"'"'s skin with a flexible, zigzag shaped adhesive strip provided along the perimeter of said medical device.

14. The medical device of claim 13, wherein the adhesive strip comprises an elastomer or foam layer.

15. The medical device of claim 1, wherein the pump mechanism is controlled to administer a preprogrammed drug delivery profile to the user.

16. A medical device for administering drug therapy to a user over an extended period of use, said medical device comprising:

a pump mechanism for administering a drug to the user;

a delivery cannula for infusing said drug transdermally into the user at an infusion site; and

a mechanism for controlling deployment of the cannula into said user, wherein said mechanism is configured to variably move said cannula to a first depth and a second depth.

17. The medical device of claim 16, wherein the mechanism for controlling deployment of said cannula is configured to retract said cannula after a predetermined period of use and further re-deploy said cannula into said user after a predetermined period of non-use.

18. The medical device of claim 16, wherein the pump mechanism and mechanism for controlling deployment of the cannula are contained in a reusable portion of the medical device.

19. A method for extending the use of a medical device comprising a first and second delivery cannula for administering drug therapy to a user, the method comprising:

deploying the first cannula into the user at an infusion site for administering a drug to the user;

retracting said first cannula from said user; and

deploying the second cannula into said user at a second infusion site for administering said drug to said user.

20. The method of claim 19, further comprising the steps of determining whether the infusion site is no longer viable by detecting that the first cannula is blocked or is incapable of delivering a desired flow of drug to the user and retracting said first cannula from said user when it is determined that the infusion site is no longer viable.

21. The method of claim 19, further comprising retracting said first cannula from said user after a predetermined period of use.

22. The method of claim 19, wherein the steps of deploying further comprise automatically deploying the respective cannulas into the user at the respective infusion sites.

23. The method of claim 19, wherein the steps of deploying further comprise manually deploying the respective cannulas into the user at the respective infusion sites.

24. A method for extending the use of a medical device comprising a single delivery cannula for administering drug therapy to a user, the method comprising:

deploying the delivery cannula into the user at an infusion site to a desired depth for administering a drug to said user;

variably moving said cannula to a second desired depth, while administering said drug to said user.

25. The method of claim 24, further comprising the steps of determining whether a flow of the drug to said user is inhibited and variably moving said cannula to said second desired depth when it is determined that the flow of the drug is inhibited.

26. The method of claim 24, further comprising the step of variably moving said cannula to said second desired depth after a predetermined period of use.

27. A method for extending the use of a medical device comprising a single delivery cannula for administering drug therapy to a user, the method comprising:

deploying the delivery cannula into the user at an infusion site to a desired depth for administering a drug to said user;

determining a predetermined period of time has lapsed since deployment of said delivery cannula;

retracting said cannula from the user when it is determined that the predetermined time has lapsed; and

re-inserting the cannula at the infusion site, after a second predetermined period, for re-administering the drug to said user.

28. The method of claim 27, wherein in the step of re-inserting the cannula at the infusion site, the cannula is re-inserted to a second desired depth.

29. A partially disposable and partially reusable medical device for administering drug therapy to a user, said medical device comprising:

a reusable housing and a disposable housing, each with at least one exposed interface for engaging each other;

wherein

the reusable housing contains;

a pump mechanism for administering a drug to the user;

a cannula deployment mechanism for deploying a delivery cannula for infusing said drug into the user; and

a controller for controlling the pump mechanism and the cannula deployment mechanism;

and

the disposable housing contains;

the delivery cannula; and

a reservoir for housing a drug supply for infusion into said user.

30. The medical device of claim 29, wherein the reusable housing further contains a sensor deployment mechanism.

31. The medical device of claim 29, wherein the medical device comprises a second disposable housing, containing a sensor deployment mechanism.

32. The medical device of claim 31, wherein the disposable housing is attachable to and detachable from the reusable housing while the second disposable housing is attached to the reusable housing, and the reusable housing is affixed to the user.

33. The medical device of claim 29, wherein the disposable housing comprises a key engageable with the reusable housing that orients a position of the delivery cannula.

34. The medical device of claim 33, wherein a position of a delivery cannula in a replacement disposable housing is spaced apart from said position of the delivery cannula of a spent disposable housing that is replaced.

35. The medical device of claim 34, wherein the position of the delivery cannula in the replacement disposable housing is spaced apart from the position of the delivery cannula of the spent disposable housing that is replaced by between 0.5 and 2.5 inches.

36. The medical device of claim 34, wherein the position of the delivery cannula in the replacement disposable housing is spaced apart from the position of the delivery cannula of the spent disposable housing that is replaced by between 1.25 and 1.75 inches.

37. The medical device of claim 32, wherein the disposable housing comprises a key engageable with the second disposable housing that orients a position of the delivery cannula.

38. The medical device of claim 37, wherein a position of a delivery cannula in a replacement disposable housing is spaced apart from said position of the delivery cannula of a spent disposable housing that is replaced.

39. The medical device of claim 38, wherein the position of the delivery cannula in the replacement disposable housing is spaced apart from the position of the delivery cannula of the spent disposable housing that is replaced by between 0.5 and 2.5 inches.

40. The medical device of claim 38, wherein the position of the delivery cannula in the replacement disposable housing is spaced apart from the position of the delivery cannula of the spent disposable housing that is replaced by between 1.25 and 1.75 inches.

41. The medical device of claim 29, wherein the reusable housing and the disposable housing are configured to communicate with each other using a personal area network that transmits data across the user'"'"'s body.

42. The medical device of claim 31, wherein the second disposable housing is configured to communicate with the reusable housing via a personal area network that transmits data across the user'"'"'s body.

43. The medical device of claim 29, wherein the pump mechanism comprises one of a micro-motor, linear actuator, and motor with a high-reduction gear reducer.

44. The medical device of claim 43, wherein the controller for controlling the pump mechanism is selected from the group consisting of a PI controller and a PD controller.

45. The medical device of claim 44, wherein said medical device is used for administering drug therapy to a user with Type II diabetes.

46. The medical device of claim 29, wherein the disposable housing comprises a hydrophobic membrane along a flow channel adjacent the cannula deployment mechanism, wherein said hydrophobic membrane enables the passage of air to pass through the flow channel during an initial priming of said medical device.

47. A programmable drug delivery device for administering drug therapy to a user, said programmable drug delivery device comprising:

a housing comprising a programmable controller, a drug cartridge, an infusion needle, and a mechanism for metering a calculated bolus dose of a drug to the user, wherein the controller is programmed by a host device which calculates the bolus dose of the drug to be administered to the user through said infusion needle and programs the controller to set said dosage to be administered to the user.

48. The programmable drug delivery device of claim 47, wherein the programmable drug delivery device comprises a programmable insulin pen.

49. The programmable drug delivery device of claim 47, wherein the host device is one of a personal diabetes monitor, a blood glucose monitor, a bolus calculator, and a wearable drug infusion device.

50. The programmable drug delivery device of claim 47, wherein the host device calculates the bolus dose from at least one factor selected from the list consisting of a test strip result, bodily function sensor signal, basal rate infusion history, and meal information.

51. The programmable drug delivery device of claim 47, wherein the housing further comprises an electrical contact for directly communicating with the host device.

52. The programmable drug delivery device of claim 51, wherein the programmable controller is programmed by the host device when in direct communication with the host device.

53. The programmable drug delivery device of claim 51, wherein the housing further comprises a rechargeable battery that is recharged when the programmable drug delivery device is in contact with the host device.

54. The programmable drug delivery device of claim 47, wherein the programmable delivery device and the host device communicate via a personal area network that transmits a signal across the user'"'"'s body.

55. The programmable drug delivery device of claim 47, wherein the mechanism for metering a calculated bolus dose of a drug to the user comprises a micro-pump provided between the infusion needle and the drug cartridge.

56. The programmable drug delivery device of claim 47, wherein the mechanism for metering a calculated bolus dose of a drug to the user comprises a linear actuator provided at a proximal end of the drug cartridge that displaces a fluid in said drug cartridge.

57. A wearable medical device for administering drug therapy to a user, said medical device comprising:

an integral housing containing a reservoir for housing a supply of a drug, in fluid communication with an infusion cannula for delivering the drug to the user, a pump mechanism device for administering delivery of the drug from the reservoir to the user through the infusion cannula, and a preprogrammed controller to control the pump mechanism to provide a preprogrammed drug delivery profile to the user.

58. The medical device of claim 57, wherein the controller is pre-programmed by either a manufacturer of the medical device or a health care provider.

59. The medical device of claim 57, wherein the controller is pre-programmed to provide a specific drug infusion rate according to an electronic timer or the time of day.

60. The medical device of claim 57, wherein the controller is pre-programmed to provide multiple daily infusions of a dosage of drug to the user.

61. A method for administering extended drug therapy to a user using a partially reusable and partially disposable medical device, the method comprising:

affixing a reusable housing at a location on a user'"'"'s body;

engaging a first disposable housing to the reusable housing at a disposable housing engagement site, the first disposable housing having an infusion site at a first location;

providing drug therapy to the user from a reservoir provided in the first disposable housing;

disengaging said first disposable housing from said reusable housing;

engaging a second disposable housing to said reusable housing at said disposable housing engagement site, the second disposable housing having an infusion site at a second location; and

providing drug therapy to the user from a reservoir provided in the second disposable housing.

62. The method of claim 61, wherein the second infusion site is spaced apart from the first infusion site by between 0.5 and 2.5 inches.

63. The method of claim 61, wherein the second infusion site is spaced apart from the first infusion site by between 1.25 and 1.75 inches.

64. The method of claim 61, wherein the first and second disposable housings contain a key for engaging said reusable housing to orient a position of their respective infusion sites.

65. The method of claim 61, further comprising engaging an extended use disposable housing to said reusable housing at an extended use disposable housing engagement site.

66. The method of claim 65, wherein the extended use disposable housing comprises a blood glucose sensor that is inserted into the skin of a user.

67. The method of claim 65, wherein said extended use disposable housing engaging step occurs prior to the disengaging step, and said extended use disposable housing remains engaged to the reusable housing after the second disposable housing engagement step.