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

• US 6,997,907 B2
• Filed: 02/21/2003
• Issued: 02/14/2006
• Est. Priority Date: 02/05/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: McConnell, Susan M., Safabash, Jason H., Funderburk, Jeffery V., Adair, Randy W., Field, Jeffrey F., Marano, April A.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US10/371,137
• Publication Number:
  US 20030125669A1
• Time in Patent Office: 1,089 Days
• Field of Search: 604/116, 604/156, 604/157, 604/93.01, 604/164.01, 604/164.04, 604/164.12, 604/165.01, 604/165.02, 604/165.03, 604/264, 604/272
• US Class Current: 604/157
• 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 set for insertion through the skin of a patient includes at least one piercing member adapted to be secured to an insertion device and a set housing to be removable from the insertion device while maintaining installation of the insertion set. At least a portion of the at least one piercing member is insertable through the skin. The set housing is coupled to the at least one piercing member and is adapted so that it is shaped to fit an insertion device to orient the at least one piercing member for placement through the skin of at least a portion of the at least one piercing member at a predetermined angle relative to the skin to install the insertion set. The at least one piercing member is adapted to be retainable by the insertion device during removal from the insertion set.

Claims

1. An insertion set for insertion through the skin of a patient by an insertion device, 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 wherein the at least one piercing member is adapted to be secured to an insertion device; and

a set housing coupled to the at least one piercing member, wherein the set housing is adapted so that it is shaped to fit an 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 a predetermined angle relative to the skin of the patient to install the insertion set to the patient,

wherein the insertion set is adapted to move, upon actuation, from a retracted position to an advanced position while the at least one piercing member is being inserted through the skin of the patient, and

wherein the set housing of the insertion set is adapted to be removable from the insertion device while maintaining the installation of the insertion set to the patient, and wherein the at least one piercing member is adapted to be retainable by the insertion device during removal from the insertion set such that the secured at least one piercing member may be removed from the insertion set while maintaining the installation of the insertion set to the patient.

2. An insertion set according to claim 1, wherein the insertion set is adapted to be prepackaged in a carrier body of the insertion device for insertion of the insertion set to the patient.

3. An insertion set according to claim 2, wherein the prepackaged insertion set and carrier body of the insertion device are adapted to be loaded into the insertion device prior to insertion of the insertion set to the patient.

4. An insertion set according to claim 1, wherein the at least one piercing member is adapted to be removed from the insertion device after being removed from the insertion set.

5. An insertion set according to claim 1, wherein the insertion set further includes a cannula supported by the at least one piercing member of the insertion set to insert the cannula through the skin of the patient, and wherein the at least one piercing member is adapted to be removed from the cannula when the insertion device is removed from the insertion set while maintaining the installation of the insertion set including the cannula to the patient.

6. An insertion set according to claim 5, wherein the at least one piercing member is adapted to be removed from the insertion device after being removed from the insertion set.

7. An insertion set according to claim 1, wherein the at least one piercing member and the set housing are specifically adapted to work with a specific insertion device.

8. An insertion set according to claim 1, wherein the set housing is adapted so that it is shaped to fit an 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 a predetermined angle of about 90 degrees relative to the skin.

9. An insertion set according to claim 1, wherein the set housing is adapted so that it is shaped to fit an insertion device to orient the at least one piercing member for placement trough the skin of the patient of at least a portion of the at least one piercing member at a predetermined angle of between 90 degrees and 10 degrees relative to the skin.

10. An insertion set according to claim 1, wherein the set housing is adapted so that it is shaped to fit an 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 a predetermined angle relative to the skin such that after insertion, the angle between the at least one piercing member and the skin is greater than 0 degrees and less than or equal to 10 degrees.

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

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

13. An insertion set according to claim 1, wherein the insertion set is adapted to rest mainly on the surface of the skin after insertion.

14. An insertion set according to claim 1, wherein the insertion set is adapted to be fully implanted in the skin of the patient after insertion.

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

16. An insertion set according to claim 1, wherein the at least one piercing member is a plurality of needles.

17. An insertion set according to claim 16, wherein the plurality of needles are micro-needles.

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

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

20. An insertion set according to claim 1, wherein the insertion set is both an infusion set and a sensor set combined into an integral unit.

21. An insertion set according to claim 1, wherein the insertion set is adapted to be inserted to avoid contacting bone.

22. An insertion set according to claim 1, wherein the at least one piercing member includes a hub, which is adapted to be secured to the insertion device.

23. An insertion set according to claim 1, wherein the at least one piercing member is adapted to be secured to the insertion device during the insertion process by the insertion device, and wherein the at least one piercing member is further adapted to permit removal of the insertion device from the insertion set without the need to remove the at least one piercing member from the insertion set housing.

24. An insertion set according to claim 1, wherein the insertion set is designed to come in contact with patient interstitial fluid.

25. An insertion set according to claim 1, wherein the insertion set is designed to minimize contact with the blood vessels of the patient.

26. An insertion set according to claim 1, wherein the insertion set is designed to be randomly positioned on the skin of the patient.

27. An insertion set according to claim 1, wherein the insertion set is designed to be randomly positioned on the skin of the patient independent of observation of blood vessels.

28. An insertion set according to claim 1, wherein the piercing member is configured to be shielded prior to placement of the insertion set.

29. An insertion set according to claim 1, wherein the insertion set is adapted to be concealed within the insertion device.

30. An insertion set according to claim 1, wherein the insertion set is attached to infusion tubing.

31. An insertion set according to claim 1, wherein the insertion set is designed to withstand forces associated with automatic placement of the insertion set through the skin of the patient.

32. An insertion set according to claim 1, wherein the insertion set is designed to be projected through the patient'"'"'s skin with a controlled force and speed in a manner insuring proper placement of the insertion set.

33. A method of producing an insertion set for insertion through the skin of a patient by an insertion device, the method comprising the steps of:

providing 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;

adapting the at least one piercing member so that it is shaped to be secured to an insertion device;

coupling a set housing to the at least one piercing member;

adapting the set housing so tat it is shaped to fit an 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 a predetermined angle relative to the skin of the patient to install the insertion set to the patient;

adapting the insertion set to move, upon actuation, from a retracted position to an advanced position while the at least one piercing member is being inserted through the skin of the patient;

adapting the set housing of the insertion set to be removable from the insertion device while maintaining the installation of the insertion set to the patient; and

adapting the at least one piercing member to remain secured to the insertion device during removal of the insertion device from the insertion set such that the at least one piercing member is removable from the insertion set while maintaining the installation of the insertion set to the patient.

34. A method according to claim 33, further including the step of prepackaging the insertion set in a carrier body of an insertion device for insertion of the insertion set to the patient.

35. A method according to claim 34, further including the step of adapting the prepackaged insertion set and the carrier body of the insertion device to be loaded into another portion of the insertion device prior to insertion of the insertion set to the patient.

36. A method according to claim 33, further including the step of adapting the at least one piercing member to be removed from the insertion device after being removed from the insertion set.

37. A method according to claim 33, further including the step of providing a cannula that is supported by the at least one piercing member of the insertion set to insert the cannula through the skin of the patient, and further including the step of adapting the at least one piercing member to be removed from the cannula when the insertion device body is removed from the insertion set, while maintaining the installation of the insertion set to the patient.

38. A method according to claim 37, further including the step of adapting the at least one piercing member to be removed from the insertion device after being removed from the insertion set.

39. A method according to claim 33, further including the step of adapting the set housing so that it is shaped to fit an 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 a predetermined angle of about 90 degrees relative to the skin.

40. A method according to claim 33, further including the step of adapting the set housing so that it is shaped to fit an 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 a predetermined angle of between 90 degrees and 10 degrees relative to the skin.

41. A method according to claim 33, further including the step of adapting the set housing so that is shaped to fit an insertion device to orient the at least one piercing member far placement through the skin of the patient of at least a portion of the at least one piercing member at a predetermined angle relative to the skin such that after insertion, the angle between the at least one piercing member and the skin is greater than 0 degrees and less than or equal to 10 degrees.

42. A method according to claim 33, wherein the insertion set is a transcutaneous insertion set.

43. A method according to claim 33, wherein the insertion set is a subcutaneous insertion set.

44. A method according to claim 33, wherein the insertion set is adapted so that it rests mainly on the surface of the skin after insertion.

45. A method according to claim 33, wherein the insertion set is adapted so that it is fully implantable in the skin of the patient.

46. A method according to claim 33, wherein the at least one piercing member is a needle.

47. A method according to claim 33, wherein the at least one piercing member is a plurality of needles.

48. A method according to claim 47, wherein the plurality of needles are micro-needles.

49. A method according to claim 33, wherein the insertion set is an infusion set.

50. A method according to claim 33, wherein the insertion set is a sensor set.

51. A method according to claim 33, wherein the insertion set is both an infusion set and a sensor set combined into an integral unit.

52. A method according to claim 33, further including the step of adapting the insertion set to be inserted to avoid contacting bone.

53. A method according to claim 33, wherein the insertion set is designed to come in contact with patient interstitial fluid.

54. A method according to claim 33, wherein the insertion set is designed to minimize contact with the blood vessels of the patient.

55. A method according to claim 33, wherein the insertion set is designed to be randomly positioned on the skin of the patient.

56. A method according to claim 33, wherein the insertion set is designed to be randomly positioned on the skin of the patient independent of observation of blood vessels.

57. A method according to claim 33, wherein the piercing member is configured to be shielded prior to placement of the insertion set.

58. A method according to claim 33, wherein the insertion set is adapted to be concealed within the insertion device.

59. A method according to claim 33, wherein the insertion set is attached to infusion tubing.

60. A method according to claim 33, wherein the insertion set is designed to withstand forces associated with automatic placement of the insertion set through the skin of the patient.

61. A method according to claim 33, wherein the insertion set is designed to be projected through the patient'"'"'s skin with a controlled force and speed in a manner insuring proper placement of the insertion set.