INSERTION DEVICE FOR AN INSERTION SET AND METHOD OF USING THE SAME

• US 20140094756A1
• Filed: 12/09/2013
• Published: 04/03/2014
• Est. Priority Date: 02/05/1997
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Bobroff, Randa M., Kiliszewski, Lawrence, Lickliter, Hans, Houghton, Frederick C., Safabash, Jason H., McConnell, Susan M., Marano, April A.
• Application Number:
  US14/100,777
• Publication Number:
  US 20140094756A1
• Time in Patent Office: Days
• US Class Current: 604/164.04
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/3249 Means to disalign the needle tip and the distal needle passage of a needle protection sleeve
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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 insertion device and insertion set. The insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient includes a device housing, a carrier body and a driver. The carrier body is slidably received within the device housing for movement between an advanced position and a retracted position. The carrier body also includes a receiving structure to support the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at a predetermined or variable angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position. The driver is operatively coupled between the device housing and the carrier body to urge the carrier body from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set thorough the skin of the patient to install the insertion set to the patient. The receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

Claims

1. An insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient, the insertion device comprising:

a device housing including an angled end of the housing device to support a selectable insertion angle of the insertion device relative to the skin of the patient;

a carrier body slidably received within the device housing for movement between an advanced position and a retracted position, the carrier body includes a receiving structure to support the insertion set in a position with at least one piercing member oriented for insertion through the skin of the patient at the selectable insertion angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

a driver operatively coupled between the device housing and the carrier body to urge the carrier body from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set through the skin of the patient to install the insertion set to the patient; and

wherein the receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

2. An insertion device according to claim 1, wherein a portion of the angled end includes a multi-planar surface to facilitate the selection of selectable insertion angle.

3. An insertion device according to claim 1, wherein the angled end is a separate-rotatable member connected to the device housing by at least one pin to facilitate the movement of the device housing about the separate-rotatable member and support the selectable insertion angle of the insertion device.

4. An insertion device according to claim 3, wherein the separate-rotatable member of the device housing includes a contact surface to provide a substantially flat contact surface for the insertion device against the patient'"'"'s skin.

5. An insertion device according to claim 1, wherein the piercing-member insertion angle is from 20 degrees to 45 degrees.

6. An insertion device according to claim 1, wherein the piercing-member insertion angle is greater than 0 and less than or equal to 20.

7. An insertion device according to claim 1, wherein a portion of the angled end forms a curved opening with two arms surrounding the receiving structure, and wherein the two arms extend beyond the receiving structure of the carrier body to support the device housing at the selectable insertion angle of the insertion device.

8. An insertion device according to claim 1, wherein the receiving structure has a skin contacting surface with a multi-planar front end, wherein the multi-planar front end of the receiving structure is shaped to be co-extensive with the angled end of the device housing when the carrier body is in the advanced position to facilitate insertion at the selectable insertion angle of the device housing relative to the patient'"'"'s skin.

9. An insertion device according to claim 8, wherein the receiving structure includes a locking mechanism to engage at least a portion of the insertion set.

10. An insertion device according to claim 9, wherein the locking mechanism includes teeth, wherein the teeth are coupled to the insertion set and secured in position by a spring member to facilitate locking and placement of the piercing member at the selectable insertion angle of the device housing relative to the patient'"'"'s skin.

11. An insertion device according to claim 1, wherein the selectable insertion angle relative to the skin is about 90 degrees.

12. An insertion device according to claim 1, wherein the selectable insertion angle relative to the skin is between 90 degrees and 10 degrees.

13. An insertion device according to claim 1, wherein the selectable angle relative to the skin after insertion is greater than 0 and less than or equal to 10 degrees.

14. An insertion device according to claim 1, wherein the insertion set is a transcutaneous insertion set.

15. An insertion device according to claim 1, wherein the insertion set is a subcutaneous insertion set.

16. An insertion device according to claim 1, wherein the insertion set rests mainly on the surface of the skin after insertion.

17. An insertion device according to claim 1, wherein the insertion set is fully implanted in the skin of the patient.

18. An insertion device according to claim 1, wherein the at least one piercing member is a needle.

19. An insertion device according to claim 1, wherein the at least one piercing member is at least one needle.

20. An insertion device according to claim 1, wherein at least one needle is a micro-needle.

21. An insertion device according to claim 1, wherein the insertion set is an infusion set.

22. An insertion device according to claim 1, wherein the insertion set is a sensor set.

23. An insertion device according to claim 1, further including a trigger mechanism that actuates the driver.

52. An insertion device according to claim 1, wherein the insertion device is removable from the insertion set.

53. An insertion device according to claim 52, wherein the insertion device is completely removable from the insertion set.

54. An insertion device according to claim 1, wherein the insertion set is inserted to avoid contacting bone.

55. An insertion device according to claim 54, wherein the at least one piercing member terminates in flesh.

56. An insertion device according to claim 1, further including a safety structure on the carrier body that retains the insertion set during forward movement of the carrier body from the retracted position to the advanced position.

57. An insertion device according to claim 56, wherein the safety structure on the carrier body retains the insertion set upon completion of the forward movement of the carrier body to inhibit further forward motion of the insertion set.

58. An insertion device according to claim 1, wherein the insertion set adheres to the skin.

59. An insertion device according to claim 1, wherein an infusion tube is attached to the insertion set during insertion.

60. An insertion device according to claim 1, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

24. An insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient, the insertion device comprising:

device housing means for holding parts of the insertion device, wherein the device housing means include angled end means for supporting a selectable insertion angle relative to the skin of the patient upon the movement of the angled end means and the placement of the insertion device relative to the skin of the patient;

carrier means slidably received within the device housing means for movement between an advanced position and a retracted position, wherein the carrier means includes receiving means for supporting the insertion set in a position with the at least one piercing member oriented for insertion through the skin of the patient at the selectable insertion angle relative to the skin of the patient upon movement of the carrier means from the retracted position to the advanced position;

driver means operatively coupled between the device housing means and the carrier means to urge the carrier means from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set thorough the skin of the patient to install the insertion set to the patient; and

wherein the receiving means of the carrier means is removable from the insertion set while maintaining the installation of the insertion set to the patient.

25. An insertion device according to claim 24, wherein a portion of the angled end means includes multi-planar means for supporting the insertion device relative to the patient'"'"'s skin to facilitate selection of the selectable insertion angle.

26. An insertion device according to claim 25, wherein a portion of the angled end means forms partially open curved means extending beyond the receiving means for supporting the piercing member against the patient'"'"'s skin at the selected angle.

27. An insertion device according to claim 25, wherein the receiving means has a skin contacting means with a multi-planar front means, wherein the multi-planar front means of the receiving means is shaped to be co-extensive with the angled front means of the device housing means when the carrier means is in the advanced position to facilitate insertion at the selectable insertion angle of the device housing means relative to the patient'"'"'s skin.

28. An insertion device according to claim 24, wherein the receiving means structure includes locking means to hold at least a portion of the insertion set.

29. An insertion device according to claim 28, wherein the locking means includes teeth, wherein the teeth are coupled to the insertion set and secured in position by spring means to facilitate the placement and locking of the piercing member at the selectable insertion angle of the device housing means relative to the patient'"'"'s skin.

30. An insertion device according to claim 24, wherein the selectable insertion angle relative to the skin is about 90 degrees.

31. An insertion device according to claim 24, wherein the selectable insertion angle relative to the skin is between 90 degrees and 10 degrees.

32. An insertion device according to claim 24, wherein the selectable angle relative to the skin after insertion is greater than 0 and less than or equal to 10 degrees.

33. An insertion device according to claim 24, wherein the insertion set is a transcutaneous insertion set.

34. An insertion device according to claim 24, wherein the insertion set is a subcutaneous insertion set.

35. An insertion device according to claim 24, wherein the insertion set rests mainly on the surface of the skin after insertion.

36. An insertion device according to claim 24, wherein the insertion set is fully implanted in the skin of the patient.

37. An insertion device according to claim 24, wherein at least one piercing member is a needle.

38. An insertion device according to claim 37, wherein at least one piercing member is at least one needle.

39. An insertion device according to claim 37, wherein at least one needle is a micro-needle.

40. An insertion device according to claim 24, wherein the insertion set is an infusion set.

41. An insertion device according to claim 24, wherein the insertion set is a sensor set.

42. An insertion device according to claim 24, further including a trigger mechanism that actuates the driver.

43. An insertion device according to claim 24, wherein the insertion set is subcutaneous.

61. An insertion device according to claim 24, wherein the insertion device is removable from the insertion set.

62. An insertion device according to claim 61, wherein the insertion device is completely removable from the insertion set.

63. An insertion device according to claim 24, wherein the insertion set is inserted to avoid contacting bone.

64. An insertion device according to claim 63, wherein the at least one piercing member terminates in flesh.

65. An insertion device according to claim 24, wherein the insertion set adheres to the skin.

66. An insertion device according to claim 24, wherein an infusion tube is attached to the insertion set during insertion.

67. An insertion device according to claim 24, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

44. An insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient, the insertion device comprising:

a device housing to support the insertion device relative to the skin of the patient;

a carrier body slidably received within the device housing for movement between an advanced position and a retracted position, the carrier body includes a receiving structure to support the insertion set in a position with at least one piercing member oriented for insertion through the skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

a locking mechanism to engage at least a portion of an insertion set and secure it to the receiving structure of the carrier body, and to substantially prevent the premature release of the carrier body before securing it in position against the patient'"'"'s skin.

a driver operatively coupled between the device housing and the carrier body to urge the carrier body from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set through the skin of the patient to install the insertion set to the patient; and

wherein the receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

45. An insertion device according to claim 44, wherein the locking mechanism includes a lever arm coupled with teeth to secure the insertion set to the receiving end of the carrier body and a spring coupled between the lever arm and the receiving end of the carrier body to bias the lever arm in a locking position and facilitate the placement of the piercing member in the patient'"'"'s skin.

68. An insertion device according to claim 44, wherein the insertion device is removable from the insertion set.

69. An insertion device according to claim 68, wherein the insertion device is completely removable from the insertion set.

70. An insertion device according to claim 44, wherein the insertion set is inserted to avoid contacting bone.

71. An insertion device according to claim 70, wherein the at least one piercing member terminates in flesh.

72. An insertion device according to claim 44, wherein the insertion set adheres to the skin.

73. An insertion device according to claim 44, wherein an infusion tube is attached to the insertion set during insertion.

74. An insertion device according to claim 44, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

46. An insertion device for inserting at least a portion of at least one piercing member of an insertion set through the skin of a patient, the insertion device comprising:

a device housing to support the insertion device relative to the skin of the patient;

a carrier body slidably received within the device housing for movement between an advanced position and a retracted position, the carrier body includes a receiving structure to support the insertion set in a position with at least one piercing member oriented for insertion through the skin of the patient upon movement of the carrier body from the retracted position to the advanced position;

a driver operatively coupled between the device housing and the carrier body to move the carrier body from the retracted position toward the advanced position to place at least a portion of the at least one piercing member of the insertion set through the skin of the patient to install the insertion set to the patient; and

wherein the receiving structure of the carrier body is removable from the insertion set while maintaining the installation of the insertion set to the patient.

47. An insertion device according to claim 46, wherein the carrier body is a plunger to hold the insertion set and to insert it in the patient'"'"'s skin by moving from the retracted position to the advanced position.

48. An insertion device according to claim 47, wherein the carrier body is coupled to a detent within the device housing, and wherein the detent has a level that must be overcome to permit and to facilitate the movement of the plunger from the retracted position to the advanced position with a controlled force and speed.

49. An insertion device according to claim 47, wherein the carrier body is adapted for use with different types of sets.

50. An insertion device according to 46, wherein the distance traveled by the plunger within the device housing is equal to at least a distance required to fully insert the insertion set in the patient'"'"'s skin that is at least equal to an implantable length of the piercing member.

51. An insertion device according to claim 46, wherein the driver is a press surface coupled to a carrier body to allow pushing the plunger from the retracted position to the advanced position.

75. An insertion device according to claim 46, wherein the insertion device is removable from the insertion set.

76. An insertion device according to claim 75, wherein the insertion device is completely removable from the insertion set.

77. An insertion device according to claim 46, wherein the insertion set is inserted to avoid contacting bone.

78. An insertion device according to claim 77, wherein the at least one piercing member terminates in flesh.

79. An insertion device according to claim 46, wherein the insertion set adheres to the skin.

80. An insertion device according to claim 46, wherein an infusion tube is attached to the insertion set during insertion.

81. An insertion device according to claim 46, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

82. An insertion set for insertion through the skin of a patient by an insertion device having a carrier body for movement between an advanced position and a retracted position, the carrier body of the insertion device including a receiving structure to support the insertion set in a position for insertion through the skin of the patient upon movement of the carrier body from the retracted position to the advanced position, and the insertion device having a driver that urges the carrier body from the retracted position toward the advanced position for insertion of the insertion set thorough the skin of the patient, the insertion set comprising:

at least one piercing member, wherein at least a portion of the at least one piercing member is insertable through the skin of the patient; and

a set housing coupled to the at least one piercing member, wherein the set housing is shaped to fit within the carrier body of the insertion device to orient the at least one piercing member for placement through the skin of the patient of at least a portion of the at least one piercing member at an angle relative to the skin of the patient to install the insertion set to the patient, and

wherein the set housing of the insertion set is removable from the receiving structure of the carrier body while maintaining the installation of the insertion set to the patient.

83. An insertion set according to claim 82, wherein the angle relative to the skin is about 90 degrees.

84. An insertion set according to claim 82, wherein the angle relative to the skin after insertion is between an angle greater than 0 and less than or equal to 10 degrees.

85. An insertion set according to claim 82, wherein the insertion set is a transcutaneous insertion set.

86. An insertion set according to claim 82, wherein the insertion set is a subcutaneous insertion set.

87. An insertion set according to claim 82, wherein the insertion set rests mainly on the surface of the skin after insertion.

88. An insertion set according to claim 82, wherein the insertion set is fully implanted in the skin of the patient.

89. An insertion set according to claim 82, wherein the at least one piercing member is a needle.

90. An insertion set according to claim 82, wherein the at least one piercing member is a plurality of needles.

91. An insertion set according to claim 90, wherein the plurality of needles are micro-needles.

92. An insertion set according to claim 82, wherein the insertion set is an infusion set.

93. An insertion set according to claim 82, wherein the insertion set is a sensor set.

94. An insertion set according to claim 82, wherein the insertion set is both an infusion set and a sensor set combined into an integral unit.

95. An insertion set according to claim 82, wherein the insertion device is removable from the insertion set.

96. An insertion set according to claim 95, wherein the insertion device is completely removable from the insertion set.

97. An insertion set according to claim 82, wherein the insertion set is inserted to avoid contacting bone.

98. An insertion set according to claim 97, wherein the at least one piercing member terminates in flesh.

99. An insertion set according to claim 82, wherein the insertion set adheres to the skin.

100. An insertion set according to claim 82, wherein an infusion tube is attached to the insertion set during insertion.

101. An insertion set according to claim 82, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

102. An insertion set according to claim 82, wherein the angle relative to the skin is between 90 degrees and 10 degrees.