Determination of position of injection needle

• US 9,008,764 B2
• Filed: 03/20/2007
• Issued: 04/14/2015
• Est. Priority Date: 03/20/2006
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Larsen, Andr
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US12/293,250
• Publication Number:
  US 20090088662A1
• Time in Patent Office: 2,947 Days
• Field of Search: 600/547, 604/67
• US Class Current: 600/547
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

The present invention relates to a method for detecting contact between an injection needle of a medication delivery device and a body of a patient. The method comprises the step of generating a contact signal in response to closure of an electrical signal path comprising an exterior surface part of the injection needle, an exterior surface part of a handle of the medication delivery device and at least part of the body of the patient. The present invention further relates to a method for determining the position of insertion of the injection needle, and to the insertion depth of the injection needle.

Claims

1. A handheld pen-shaped medication delivery device for expelling a set dose of a medicament to a user, the handheld pen-shaped medication delivery device comprising:

a housing,

a needle mount for mounting an injection needle having an electrically conducting exterior surface part, the needle receiving portion being adapted to galvanically or capacitively connect to the electrically conducting exterior surface part of the injection needle,

a handle being adapted to be gripped on or touched by the hand of the user, an electrically conducting exterior surface part forming part of the handle, the electrically conducting exterior surface part of the handle forming an integral part of the housing or an operable actuator disposed in or on the housing,

an electrical circuit comprising;

structure for determining a value of an electrical signal of a closed electrical signal path comprising an electrically conductive exterior surface part of an injection needle mounted on the device, the electrically conducting exterior surface part of the handle and at least part of the body of the user,

structure for determining which of a number of predetermined ranges of values the determined value falls within indicative of the type of tissue into which a tip of the injection needle mounted on the device has been inserted, and

structure for generating an information signal to the user of the medication delivery device.

2. A medication delivery device according to claim 1, wherein the generated information signal comprises an alarm signal, the alarm signal being generated if the determined value falls within a predetermined range of values associated with the tip of the injection needle being inserted into muscular tissue.

3. A medication delivery device according to claim 2, wherein the medication delivery device comprises a log for saving the position of an injection.

4. A medication delivery device according to claim 1, wherein the generated information signal comprises a clearing signal, the clearance signal being generated if the determined value falls within a predetermined range of values associated with the tip of the injection needle being inserted into subcutis tissue.

5. A medication delivery device according to claim 4, wherein the medication delivery device comprises a log for saving the position of an injection.

6. A medication delivery device according to claim 1, wherein the number of predetermined ranges of values comprises a first, a second and a third predetermined range.

7. A medication delivery device according to claim 6, wherein the first predetermined range comprises expected values associated with a first area of injection on the body, and wherein the second predetermined range comprises expected values associated with a second area of injection on the body, and wherein the third predetermined range comprises expected values associated with a third area of injection on the body.

8. A medication delivery device according to claim 7, wherein the first, the second and the third area of injection on the body are associated with the thigh, the stomach and a buttock, respectively.

9. A medication delivery device according to claim 8, wherein the medication delivery device comprises a log for saving the position of an injection.

10. A medication delivery device according to claim 1, wherein the determined value of the electrical signal comprises an amplitude value of a time varying electrical signal.

11. A medication delivery device according to claim 10, wherein the frequency of the time varying signal is at least 5 kHz.

12. A medication delivery device according to claim 10, wherein the time varying signal comprises a plurality of time varying signals of different frequencies.

13. A medication delivery device according to claim 1, wherein the electric circuit is further adapted to measure an impedance value of an object closing an exterior signal path between the electrically conducting surface part of an injection needle galvanically connected to the needle receiving portion and the electrically conducting exterior surface part forming part of the handle for detecting whether or not the needle is inserted into the body of the user.

14. A medication delivery device according to claim 13, further comprising signaling structure adapted to provide a signal to a user of the medication delivery device in response to a measured impedance value.

15. A medication delivery device according to claim 14, wherein the signaling structure comprises acoustical signaling structure and/or visual signaling structure.

16. A medication delivery device according to claim 13, wherein the electrical circuit is adapted for generating and providing a time varying electric signal to the needle mount or to the electrically conducting exterior surface part forming part of the handle.

17. A medication delivery device according to claim 16, wherein the time varying electrical signal has a frequency of at least 5 kHz.

18. A medication delivery device according to claim 16, wherein the time varying electrical signal has a frequency of at least 50 kHz.

19. A medication delivery device according to claim 16, wherein the time varying electrical signal has a frequency of at least 100 kHz.

20. A medication delivery device according to claim 16, wherein the time varying electrical signal has an amplitude value in the range 50-500 mV.

21. A medication delivery device according to claim 16, wherein the time varying electrical signal has an amplitude value in the range 75-250 mV.

22. A medication delivery device according to claim 16, wherein the time varying electrical signal has an amplitude value in the range 100-200 mV.

23. A medication delivery device according to claim 16, wherein the time varying electrical signal has an amplitude of approximately 150 mV.

24. A medication delivery device according claim 13, wherein the needle mount is adapted to detachably retain the injection needle in a fixed position relative to the medication delivery device.

25. A medication delivery device according to claim 13, wherein the medication delivery device comprises a log for saving the position of an injection.

26. A medication delivery device according to claim 25, wherein the log is adapted to save the position of an injection with associated parameters, the associated parameters being one or more parameters selected from the group of time of injection, amount of injected medicament and type of medicament.