Insertion device for an insertion set and method of using the same

• US 7,318,816 B2
• Filed: 03/14/2003
• Issued: 01/15/2008
• Est. Priority Date: 02/05/1997
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: McConnell, Susan M., Lickliter, Hans, Bobroff, Randa M., Kiliszewski, Lawrence, Marano, April A., Safabash, Jason H., Houghton, Frederick C.
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J
• APPLICATION: US 20030225373A1
• Time in patent office: 1768 Days
• Field of Search: 604134-136, 604/164.01, 604/164.08, 604/164.09, 604/164.12, 604/263, 604/533, 604/116, 604/110
• US Class Current: 604/136
• 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.

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

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

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

27. An insertion device according to claim 26, wherein the at least one piercing member terminates in flesh.

28. 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.

29. An insertion device according to claim 28, 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.

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

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

32. 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.

33. 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.

34. An insertion device according to claim 33, 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.

35. An insertion device according to claim 34, 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.

36. An insertion device according to claim 34, 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.

37. An insertion device according to claim 33, wherein the receiving means structure includes locking means to hold at least a portion of the insertion set.

38. An insertion device according to claim 37, 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.

39. An insertion device according to claim 33, wherein the selectable insertion angle relative to the skin is about 90 degrees.

40. An insertion device according to claim 33, wherein the selectable insertion angle relative to the skin is between 90 degrees and 10 degrees.

41. An insertion device according to claim 33, wherein the selectable angle relative to the skin after insertion is greater than 0 and less than or equal to 10 degrees.

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

43. An insertion device according to claim 33, wherein the insertion set is a subcutaneous insertion set.

44. An insertion device according to claim 33, wherein the insertion set rests mainly on the surface of the skin after insertion.

45. An insertion device according to claim 33, wherein the insertion set is fully implanted in the skin of the patient.

46. An insertion device according to claim 33, wherein at least one piercing member is a needle.

47. An insertion device according to claim 46, wherein at least one piercing member is at least one needle.

48. An insertion device according to claim 46, wherein at least one needle is a micro-needle.

49. An insertion device according to claim 33, wherein the insertion set is an infusion set.

50. An insertion device according to claim 33, wherein the insertion set is a sensor set.

51. An insertion device according to claim 33, further including a trigger mechanism that actuates the driver.

52. An insertion device according to claim 33, wherein the insertion set is a subcutaneous insertion set.

53. An insertion device according to claim 33, wherein the insertion device is removable from the insertion set.

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

55. An insertion device according to claim 33, wherein the insertion set is inserted to avoid contacting bone.

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

57. An insertion device according to claim 33, wherein the insertion set adheres to the skin.

58. An insertion device according to claim 33, wherein an infusion tube is attached to the insertion set during insertion.

59. An insertion device according to claim 33, wherein the controlled force and speed that urges the carrier body from the retracted position to the advanced position is incapable of piercing bone.

60. 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.

61. An insertion device according to claim 60, 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.

62. An insertion device according to claim 60, wherein the insertion device is removable from the insertion set.

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

64. An insertion device according to claim 60, wherein the insertion set is inserted to avoid contacting bone.

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

66. An insertion device according to claim 60, wherein the insertion set adheres to the skin.

67. An insertion device according to claim 60, wherein an infusion tube is attached to the insertion set during insertion.

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