Controllable sensor insertion needle

• US 9,662,070 B2
• Filed: 11/11/2011
• Issued: 05/30/2017
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Deck, Frank, Roesicke, Bernd, Rittinghaus, Andrea
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US13/294,643
• Publication Number:
  US 20120078072A1
• Time in Patent Office: 2,027 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2005/1585 Needle inserters
• 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 is proposed for at least partly inserting a subcutaneous device, more particularly a subcutaneous sensor for detecting at least one analyte, into body tissue. The insertion device has at least one insertion aid and at least one subcutaneous device. The insertion aid has at least one substantially rigidly designed base body, more particularly an insertion needle, for insertion into the body tissue. The insertion device is designed to generate an adjustable holding force between the base body and the subcutaneous device. The insertion device is designed to set the holding force during the insertion such that the subcutaneous device is held against the base body. The insertion device is furthermore designed to set the holding force after the insertion such that the subcutaneous device is detachable from the base body.

Claims

1. An insertion device for inserting a subcutaneous device for detecting an analyte into body tissue, comprising:

an insertion aid having a base body shaped like a needle for insertion into the body tissue; and

a subcutaneous device;

wherein the insertion device is configured to generate an adjustable holding force between the base body and the subcutaneous device, the holding force being configured to hold the subcutaneous device against the base body during insertion into the body tissue, and the holding force being adjustable after the insertion such that the subcutaneous device is detachable from the base body; and

further wherein the holding force is applied substantially transverse to the direction of movement of the sensor during the insertion.

2. The insertion device of claim 1, wherein the holding force is configured to prevent spatial displacement between the subcutaneous device and the base body in an insertion direction during the insertion.

3. The insertion device of claim 1, wherein the holding force comprises a non-mechanical holding force.

4. The insertion device of claim 1, wherein the insertion device is designed to set the holding force after the insertion to repel the subcutaneous device from the base body.

5. The insertion device of claim 1, wherein the holding force comprises an electrostatic holding force.

6. The insertion device of claim 5 wherein the base body has a first electrode and the subcutaneous device has a second electrode and the insertion device is configured to apply different electric potentials to the first electrode and the second electrode.

7. The insertion device of claim 6, further comprising at least one insulator between the first electrode and the second electrode.

8. The insertion device of claim 1, wherein the holding force comprises a magnetic holding force.

9. The insertion device of claim 8, wherein the insertion aid and/or the subcutaneous device comprises at least one electromagnetic holding element for generating a magnetic field.

10. The insertion device of claim 9, wherein the electromagnetic holding element comprises at least one printed conductor loop.

11. The insertion device of claim 9, further comprising at least one current source configured to generate an adjustable current.

12. The insertion device of claim 1, wherein the insertion device is configured to influence an electric charge carrier density and/or an electric conductivity in the region of at least one adhesion surface of the insertion aid and/or subcutaneous device.

13. The insertion device of claim 12, wherein the influence is generated by a field effect.

14. The insertion device of claim 12, wherein the adhesion surface has at least one conductive or semiconducting organic material.

15. The insertion device of claim 14, wherein the at least one conductive or semiconducting organic material comprises a conjugated polymer.

16. The insertion device of claim 1, wherein the insertion aid comprises a support surface on which the subcutaneous device rests during the insertion.

17. The insertion device of claim 16, wherein the support surface is substantially planar.

18. The insertion device of claim 1, wherein the base body comprises an insertion needle.

19. A method of inserting a subcutaneous sensor into body tissue, comprising:

providing an insertion aid having a base body shaped like a needle;

providing a subcutaneous sensor;

generating an electrostatic or magnetic holding force to hold the base body against the subcutaneous sensor;

inserting the subcutaneous sensor into the body tissue with the insertion aid while the holding force holds the subcutaneous sensor against the base body, wherein the holding force is applied substantially transverse to the direction of movement of the sensor during the insertion;

adjusting the holding force after the insertion; and

detaching the subcutaneous sensor from the base body.

20. The method of claim 19, wherein the holding of the subcutaneous sensor against the base body comprises preventing spatial displacement between the subcutaneous sensor and the base body in an insertion direction during the insertion.

21. The method of claim 19, wherein the holding force is generated between electrodes disposed on the subcutaneous sensor and insertion aid.

22. The method of claim 19, wherein the adjusting of the holding force after the insertion comprises repelling the subcutaneous sensor from the base body.

23. The method of claim 19, wherein the base body has a first electrode and the subcutaneous sensor has a second electrode and the generating of the holding force comprises applying different electric potentials to the first electrode and the second electrode.

24. The method of claim 23, further comprising providing at least one insulator between the first electrode and the second electrode.

25. The method of claim 19, wherein the holding force comprises a magnetic holding force.

26. The method of claim 25, wherein the holding force is generated with a printed conductor loop.

27. The method of claim 26, further comprising providing an adjustable current to the conductor loop.

28. The method of claim 19, wherein the step of generating the holding force comprises influencing an electric charge carrier density and/or an electric conductivity in the region of at least one adhesion surface of the insertion aid and/or subcutaneous sensor.

29. The method of claim 28, further comprising generating the influence by a field effect.

30. The method of claim 28, wherein the adhesion surface comprises a conjugated polymer.

31. The method of claim 19, further comprising removing the base body from the subcutaneous sensor while retaining at least a portion of the subcutaneous sensor in the body tissue.

32. The method of claim 31, further comprising measuring with the subcutaneous sensor the presence or concentration of at least one analyte in body fluid in the body tissue.