Infusion assembly

• US 20080281270A1
• Filed: 05/11/2007
• Published: 11/13/2008
• Est. Priority Date: 05/11/2007
• Status: Active Grant

• Current Assignee: Calibra Medical, Inc. (CeQur SA)
• Original Assignee: Seattle Medical Technologies
• Inventors: Cross, Brett, Carter, Brett J., Dale, Nathan
• Granted Patent: US 7,931,621 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• CPC Class Codes: A61M 2005/1426 with means for preventing access to the needle after use
• 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 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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

Abstract

An infusion assembly comprises a cannula subassembly and a source subassembly. The cannula subassembly includes a substantially planar base, a cannula projecting from the base so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a generally cylindrical docking structure having a center axis substantially perpendicular to the base. A liquid medicament is dispensed from the cannula. The source subassembly is arranged to dock with the docking structure and includes a supply of liquid medicament that couples to the cannula upon the source subassembly docking with the cannula subassembly. The source subassembly also includes a primer that automatically primes the insulin fluid path to the cannula tip when the subassemblies are joined.

Claims

1. A cannula assembly comprising:

a substantially planar base having a first surface and a second surface, the first surface being opposite the second surface and adapted to adhere to a patient'"'"'s skin;

a cannula projecting from the base first surface so as to be beneath the patient'"'"'s skin when the assembly is deployed; and

a generally cylindrical docking structure having a center axis substantially perpendicular to the base second surface and arranged to receive a source of liquid medicament to be dispensed from the cannula.

2. The assembly of claim 1, wherein the docking structure includes an upper surface having a septum that is arranged to receive a needle extending from the source of liquid medicament.

3. The assembly of claim 1, wherein the docking structure has a locking structure for locking the source of liquid medicament and the docking structure together.

4. The assembly of claim 3, wherein the locking structure is a releasable locking structure.

5. The assembly of claim 3, wherein the docking structure is arranged to receive the source in any radial orientation.

6. The assembly of claim 3, wherein the locking structure comprises a detent.

7. The assembly of claim 6, wherein the detent comprises a circumferential groove within the docking structure.

8. An infusion assembly comprising:

a cannula subassembly including a substantially planar base having a first surface and a second surface, the first surface being opposite the second surface and adapted to adhere to a patient'"'"'s skin, a cannula projecting from the base first surface so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a generally cylindrical docking structure having a center axis substantially perpendicular to the base second surface and arranged to receive a source of liquid medicament to be dispensed from the cannula; and

a source subassembly arranged to dock with the docking structure and including a supply of liquid medicament that couples to the cannula upon the source subassembly docking with the cannula subassembly.

9. The assembly of claim 8, wherein the docking structure includes an upper surface having a septum, wherein the source subassembly includes a needle coupled to the supply of liquid medicament and wherein the septum is arranged to receive the needle of the source subassembly upon the source subassembly docking with the cannula subassembly.

10. The assembly of claim 8, wherein the docking structure has a locking structure for locking to the source subassembly.

11. The assembly of claim 10, wherein the locking structure is a releasable locking structure.

12. The assembly of claim 10, wherein the docking structure and the source subassembly are arrange to dock in any radial orientation.

13. The assembly of claim 10, wherein the locking structure comprises a detent.

14. The assembly of claim 13, wherein the detent comprises a circumferential groove in the docking structure.

15. The assembly of claim 8, wherein the docking structure includes an upper surface having a septum communicating with the cannula that is arranged to receive the liquid medicament from the supply of liquid medicament and wherein the source subassembly includes a housing having an opening providing an external source of liquid medicament access to the septum.

16. The assembly of claim 8, wherein the source subassembly has a base surface adapted to adhere to the patient'"'"'s skin and wherein the base surface of the source subassembly is separate from the cannula subassembly first surface.

17. The assembly of claim 8, wherein the source subassembly includes a needle coupled to the supply of liquid medicament, wherein the cannula is coupled to the needle of the source subassembly upon the source subassembly docking with the cannula subassembly, and wherein the source subassembly further includes a primer that primes the needle and cannula with the liquid medicament upon the source subassembly docking with the cannula subassembly.

18. The assembly of claim 17, wherein the source subassembly further includes a conduit coupling the needle with the supply of liquid medicament, and wherein the primer is within the conduit.

19. The assembly of claim 18, wherein the primer comprises a collapsible reservoir within the conduit arranged to contain an amount of the liquid medicament, the reservoir being collapsible upon the source subassembly docking with the cannula subassembly to force the liquid medicament into the needle and cannula.

20. The assembly of claim 19, wherein the docking structure includes a septum, and wherein the septum is arranged to receive the needle of the source subassembly upon the source subassembly docking with the cannula subassembly.

21. The assembly of claim 20, wherein the docking structure is arranged to collapse the reservoir upon the source subassembly docking with the cannula subassembly and wherein the docking structure and the source subassembly are arranged to permit the septum to receive the needle prior to the docking structure collapsing the reservoir.

22. An infusion assembly comprising:

a cannula subassembly including a substantially planar base having a first surface and a second surface, the first surface being opposite the second surface and adapted to adhere to a patient'"'"'s skin, a cannula projecting from the base first surface so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a docking structure arranged to receive a source of liquid medicament to be dispensed from the cannula; and

a source subassembly arranged to dock with the docking structure and including a supply of liquid medicament that couples to the cannula upon the source subassembly docking with the cannula subassembly and a base surface separate from the cannula subassembly first surface and adapted to adhere to the patient'"'"'s skin.

23. The assembly of claim 22, wherein the docking structure and the source subassembly are arrange to dock in any radial orientation.

24. The assembly of claim 22, wherein the docking structure includes an upper surface having a septum, wherein the source subassembly includes a needle coupled to the supply of liquid medicament and wherein the septum is arranged to receive the needle of the source subassembly upon the source subassembly docking with the cannula subassembly.

25. The assembly of claim 24, wherein the docking structure has a locking structure for locking to the source subassembly.

26. The assembly of claim 24, wherein the locking structure is a releasable locking structure.

27. The assembly of claim 24, wherein the docking structure and the source subassembly are arrange to dock in any radial orientation.

28. The assembly of claim 22, wherein the locking structure comprises a detent.

29. The assembly of claim 22, wherein the docking structure includes an upper surface having a septum communicating with the cannula that is arranged to receive a liquid medicament from an external source of liquid medicament and wherein the source subassembly includes a housing having an opening providing an external source of liquid medicament access to the septum.

30. The assembly of claim 22, wherein the base surface of the source subassembly has a layer of adhesive to adhere the base surface to the patient'"'"'s skin and wherein the first surface of the cannula subassembly has a layer of adhesive separate from the base surface layer of adhesive of the source subassembly to adhere the cannula subassembly to the patient'"'"'s skin independently of the source subassembly.

31. The assembly of claim 22, wherein the source subassembly includes a needle coupled to the supply of liquid medicament, wherein the cannula is coupled to the needle of the source subassembly upon the source subassembly docking with the cannula subassembly, and wherein the source subassembly further includes a primer that primes the needle and cannula with the liquid medicament upon the source subassembly docking with the cannula subassembly.

32. The assembly of claim 31, wherein the source subassembly further includes a conduit coupling the needle with the supply of liquid medicament, and wherein the primer is within the conduit.

33. The assembly of claim 32, wherein the primer comprises a collapsible reservoir within the conduit arranged to contain an amount of the liquid medicament, the reservoir being collapsible upon the source subassembly docking with the cannula subassembly to force the liquid medicament into the needle and cannula.

34. The assembly of claim 33, wherein the docking structure includes a septum, and wherein the septum is arranged to receive the needle of the source subassembly upon the source subassembly docking with the cannula subassembly.

35. The assembly of claim 34, wherein the docking structure is arranged to collapse the reservoir upon the source subassembly docking with the cannula subassembly and wherein the docking structure and the source subassembly are arranged to permit the septum to receive the needle prior to the docking structure collapsing the reservoir.

36. A cannula assembly comprising:

a cannula subassembly including a substantially planar base having a first surface and a second surface, the first surface being opposite the second surface and adapted to adhere to a patient'"'"'s skin, a cannula projecting from the base first surface at a preset angle other than ninety degrees with respect to the patient'"'"'s skin so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a generally cylindrical docking structure having a center axis substantially perpendicular to the base second surface and arranged to receive a source of liquid medicament to be dispensed from the cannula; and

a cannula driver arranged to drive the cannula subassembly base first surface to a deployed position on the skin of the patient along a path defining the preset angle with respect to the patient'"'"'s skin.

37. The assembly of claim 36, wherein the cannula driver includes a needle carrying the cannula, and wherein the cannula driver is arranged to translate the needle and cannula into the deployed position beneath the patient'"'"'s skin.

38. The assembly of claim 37, wherein the cannula driver includes a drive element that drives the cannula subassembly to the deployed position with the base first surface adhered to the patient'"'"'s skin and the needle and cannula beneath the patient'"'"'s skin and at the preset angle with respect to the patient'"'"'s skin.

39. The assembly of claim 38, wherein the drive element includes a spring.

40. The assembly of claim 36, wherein the cannula driver includes a needle carrying the cannula, wherein the cannula driver is arranged to translate the needle and cannula from the cannula driver to the deployed position, and wherein the cannula driver is further arranged to withdraw the needle from the cannula and return the needle to the cannula driver leaving the cannula in the deployed position projecting from the base first surface beneath the patient'"'"'s skin.

41. The assembly of claim 40, wherein the cannula driver includes an inner compartment and wherein the cannula driver is arranged to release the needle into the inner compartment after withdrawing the needle from the cannula.

42. The assembly of claim 36, wherein the cannula driver has a distal end arranged to engage the patient'"'"'s skin and establish the path defining the preset angle with respect to the patient'"'"'s skin.

43. The assembly of claim 42, wherein the cannula driver includes a drive element that withdraws the needle from the cannula and returns the needle to the cannula driver leaving the cannula in the deployed position beneath the patient'"'"'s skin.

44. The assembly of claim 43, wherein the drive element is a spring.

45. The assembly of claim 36, wherein the cannula driver includes an actuator which, when acted upon, causes the cannula assembly to be driven to the deployed position and a lock-out structure that precludes the actuator from being inadvertently acted upon.

46. The assembly of claim 45, wherein the lock-out structure overlies the actuator.

47. The assembly of claim 46, wherein the lock-out structure is a break-away cap structure.

48. The assembly of claim 36, wherein the docking structure includes an upper surface having a septum that is arranged to receive a needle of the source of liquid medicament.

49. The assembly of claim 36, wherein the docking structure has a locking structure that locks the source of liquid medicament and the docking structure together.

50. The assembly of claim 49, wherein the locking structure is a releasable locking structure.

51. The assembly of claim 49, wherein the locking structure comprises a detent.

52. The assembly of claim 51, wherein the detent comprises a circumferential groove within the docking structure.

53. The assembly of claim 36, wherein the docking structure has a locking structure for releasably locking the cannula subassembly within the cannula driver.

54. The assembly of claim 53, wherein the locking structure comprises a detent.

55. The assembly of claim 54, wherein the detent comprises a circumferential groove within the docking structure.

56. An infusion assembly comprising:

a cannula subassembly including a base, a cannula projecting from the base so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a docking structure arranged to receive a source of liquid medicament to be dispensed from the cannula; and

a source subassembly arranged to dock with the docking structure and including a supply of liquid medicament that couples to the cannula upon the source subassembly docking with the cannula subassembly and a primer that primes the cannula with the liquid medicament upon the source subassembly docking with the cannula subassembly.

57. The assembly of claim 56, wherein the source subassembly further includes a conduit coupling the cannula with the supply of liquid medicament, and wherein the primer is within the conduit.

58. The assembly of claim 57, wherein the primer comprises a collapsible reservoir within the conduit arranged to contain an amount of the liquid medicament, the reservoir being collapsible upon the source subassembly docking with the cannula subassembly to force the liquid medicament into the cannula.

59. The assembly of claim 56, wherein the source subassembly includes a needle coupled to the supply of liquid medicament, wherein the cannula is coupled to the needle of the source subassembly upon the source subassembly docking with the cannula subassembly, and wherein the primer primes the needle and cannula with the liquid medicament upon the source subassembly docking with the cannula subassembly.

60. The assembly of claim 59, wherein the source subassembly further includes a conduit coupling the needle with the supply of liquid medicament, and wherein the primer is within the conduit.

61. The assembly of claim 59, wherein the primer comprises a collapsible reservoir within the conduit arranged to contain an amount of the liquid medicament, the reservoir being collapsible upon the source subassembly docking with the cannula subassembly to force the liquid medicament into the needle and cannula.

62. The assembly of claim 61, wherein the docking structure includes a septum, and wherein the septum is arranged to receive the needle of the source subassembly upon the source subassembly docking with the cannula subassembly.

63. The assembly of claim 62, wherein the docking structure is arranged to collapse the reservoir upon the source subassembly docking with the cannula subassembly and wherein the docking structure and the source subassembly are arranged to permit the septum to receive the needle prior to the docking structure collapsing the reservoir.

64. A cannula assembly comprising:

a cannula subassembly including a substantially planar base having a first surface and a second surface, the first surface being opposite the second surface and adapted to adhere to a patient'"'"'s skin, a cannula projecting from the base first surface at a preset angle other than ninety degrees with respect to the patient'"'"'s skin so as to be beneath the patient'"'"'s skin when the subassembly is deployed, and a docking structure projecting from the base second surface and arranged to receive a source of liquid medicament to be dispensed from the cannula; and

a cannula driver arranged to drive the cannula subassembly to a deployed position on the skin of the patient along a path defining the preset angle with respect to the patient'"'"'s skin, the cannula driver having a stabilizing base to engage the patient'"'"'s skin and an actuator arranged to be acted upon in a direction substantially transverse to the stabilizing base for actuating the cannula driver.

65. The assembly of claim 64, wherein the docking structure is generally cylindrically shaped and has a center axis substantially transverse to the base second surface.

66. The assembly of claim 64, wherein the cannula driver includes a needle carrying the cannula, and wherein the cannula driver is arranged to translate the needle and cannula into the deployed position beneath the patient'"'"'s skin.

67. The assembly of claim 64, wherein the cannula driver includes a drive element that drives the cannula subassembly to the deployed position with the base first surface adhered to the patient'"'"'s skin and the needle and cannula beneath the patient'"'"'s skin and at the preset angle with respect to the patient'"'"'s skin.

68. The assembly of claim 64, wherein the drive element includes a spring.

69. The assembly of claim 64, wherein the cannula driver includes a needle carrying the cannula, wherein the cannula driver is arranged to translate the needle and cannula from the cannula driver to the deployed position, and wherein the cannula driver is further arranged to withdraw the needle from the cannula and return the needle to the cannula driver leaving the cannula in the deployed position projecting from the base first surface beneath the patient'"'"'s skin.

70. The assembly of claim 69, wherein the cannula driver includes an inner compartment and wherein the cannula driver is arranged to release the needle into the inner compartment after withdrawing the needle from the cannula.

71. The assembly of claim 64, wherein the cannula driver has a distal end arranged to engage the patient'"'"'s skin and establish the path defining the preset angle with respect to the patient'"'"'s skin.

72. The assembly of claim 71, wherein the cannula driver includes a drive element that withdraws the needle from the cannula and returns the needle to the cannula driver leaving the cannula in the deployed position beneath the patient'"'"'s skin.

73. The assembly of claim 72, wherein the drive element is a spring.

74. The assembly of claim 64, wherein the cannula driver includes an actuator which, when acted upon, causes the cannula assembly to be driven to the deployed position and a protective cover overlying the actuator that precludes the actuator from being inadvertently acted upon.

75. The assembly of claim 74, wherein the protective cover is a cap structure.

76. The assembly of claim 75, wherein the cap structure is a break-away cap structure.

77. The assembly of claim 64, wherein the docking structure includes an upper surface having a septum that is arranged to receive a needle of the source of liquid medicament.

78. The assembly of claim 64, wherein the docking structure has a locking structure that locks the source of liquid medicament and the docking structure together.

79. The assembly of claim 78, wherein the locking structure is a releasable locking structure.

80. The assembly of claim 78, wherein the locking structure comprises a detent.

81. The assembly of claim 80, wherein the detent comprises a circumferential groove within the docking structure.

82. The assembly of claim 64, wherein the docking structure has a locking structure for releasably locking the cannula subassembly within the cannula driver.

83. The assembly of claim 82, wherein the locking structure comprises a detent.

84. The assembly of claim 83, wherein the detent comprises a circumferential groove within the docking structure.

85. A cannula driver that deploys a cannula subassembly in a deployed position on the skin of a patient, comprising:

a carrier that translates the cannula subassembly along a path defining a preset angle of other than ninety degrees with respect to the patient'"'"'s skin;

a stabilizing base to engage the patient'"'"'s skin; and

an actuator arranged to be acted upon in a direction substantially transverse to the stabilizing base for actuating the cannula driver.

86. The driver of claim 85, wherein the cannula subassembly includes a base and a cannula projecting from the base at the preset angle and wherein the carrier maintains the cannula base substantially parallel to the stabilizing base as the cannula subassembly is translated for deployment.

87. The driver of claim 85, wherein the carrier includes a needle that is received by the cannula and carries the cannula subassembly to the deployed position.

88. The driver of claim 85, further including a drive element that acts upon the carrier to drive the cannula subassembly to the deployed position.

89. The driver of claim 88, wherein the drive element includes a spring.

90. The driver of claim 85, wherein the carrier includes a needle that is received by the cannula and carries the cannula subassembly to the deployed position and wherein the cannula driver is further arranged to withdraw the needle from the cannula and return the needle to the cannula driver leaving the cannula in the deployed position projecting from the cannula subassembly base beneath the patient'"'"'s skin.

91. The driver of claim 90, wherein the cannula driver includes an inner compartment and wherein the cannula driver is arranged to release the needle into the inner compartment after withdrawing the needle from the cannula.

92. The driver of claim 90, further including a drive element that withdraws the needle from the cannula and returns the needle to the cannula driver leaving the cannula in the deployed position beneath the patient'"'"'s skin.

93. The driver of claim 92, wherein the drive element is a spring.

94. The assembly of claim 85, wherein the cannula driver includes an actuator which, when acted upon, causes the cannula assembly to be driven to the deployed position and a protective cover overlying the actuator that precludes the actuator from being inadvertently acted upon.

95. The assembly of claim 94, wherein the protective cover is a cap structure.

96. The assembly of claim 95, wherein the cap structure is a break-away cap structure.