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

• US 20030158520A1
• Filed: 02/20/2003
• Published: 08/21/2003
• 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., Marano, April A., Safabash, Jason H., Funderburk, Jeffery V., Adair, Randy W., Field, Jeffrey F.
• Granted Patent: US 7,329,239 B2
• Time in Patent Office: Days
• US Class Current: 604/116
• 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 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 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 with a controlled force and speed 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;

a carrier body slidably received within the device housing for movement between an advanced position and a retracted position, the carrier body including 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 angle relative to the skin of the patient upon movement of the carrier body from the retracted position to the advanced position; and

a driver operatively coupled between the device housing and the carrier body that urges the carrier body with a controlled force and speed 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,

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 the predetermined angle relative to the skin is about 90 degrees.

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

4. An insertion device according to claim 1, wherein the predetermined angle relative to the skin after insertion is between 0 and 10 degrees.

5. An insertion device according to claim 1, wherein the insertion set is a transuctaneous insertion set.

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

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

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

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

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

11. An insertion device according to claim 10, wherein the plurality of needles are micro-needles.

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

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

14. An insertion device according to claim 1, wherein the device housing has a forward end defining a generally planar angled insertion contact surface for placement against the skin of a patient with the device housing in a predetermined orientation relative to the patient'"'"'s skin that mirrors the predetermined angle of the insertion set relative to the skin of the patient.

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

16. An insertion device according to claim 15, wherein the trigger mechanism includes at least one trigger for fingertip depression to actuate the driver for movement of the carrier body from the retracted position to the advanced position.

17. An insertion device according to claim 1, wherein the driver includes at least one spring for spring-loaded movement of the carrier body from the retracted position to the advanced position.

18. An insertion device according to claim 1, wherein the driver includes a force changing mechanism that permits alteration of the controlled force and speed of the carrier body moving from the retracted position to the advanced position from one insertion cycle to another insertion cycle.

19. An insertion device according to claim 1, wherein the device housing and the carrier body include a cooperatively engageable track mechanism for guiding movement of the carrier body between the advanced and retracted positions while retaining the carrier body against rotation relative to the device housing.

20. An insertion device according to claim 1, wherein the at least one piercing member is provided with a piercing member hub as part of the insertion set, and further wherein the receiving structure of the carrier body includes a recess formed therein for mated slide-fit reception of the piercing member hub of the insertion set.

21. An insertion device according to claim 19, wherein the recess of the receiving structure includes a laterally open undercut recess.

22. An insertion device according to claim 19, wherein the receiving structure further includes a safety retainer structure that retains the at least one piercing member on the receiving structure during movement from the retracted position to the advanced position, the safety retainer structure permits separation of the at least one piercing member from the carrier body when the carrier body is in the advanced position.

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

24. An insertion set for insertion through the skin of a patient by an insertion device having a slidable 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 operatively coupled to the carrier body that urges the carrier body with a controlled force and speed 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 a predetermined 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.

25. An insertion set according to claim 24, wherein the predetermined angle relative to the skin is about 90 degrees.

26. An insertion set according to claim 24, wherein the predetermined angle relative to the skin is between 90 degrees and 10 degrees.

27. An insertion set according to claim 24, wherein the predetermined angle relative to the skin after insertion is between 0 and 10 degrees.

28. An insertion set according to claim 24, wherein the insertion set is a transuctaneous insertion set.

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

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

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

32. An insertion set according to claim 24, wherein the at least one piercing member is a needle.

33. An insertion set according to claim 24, wherein the at least one piercing member is a plurality of needles.

34. An insertion set according to claim 33, wherein the plurality of needles are micro-needles.

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

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

37. An insertion set according to claim 24, wherein the insertion set is both an infusion set and a sensor set combined into an integral unit.