Medical device with a collection channel for a bodily fluid

• US 8,864,664 B2
• Filed: 08/01/2011
• Issued: 10/21/2014
• Est. Priority Date: 08/04/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Arnold, Marc, Brugger, Tobias, Braun, Jrgen
• Primary Examiner(s): BERHANU, ETSUB D
• Application Number:
  US13/195,368
• Publication Number:
  US 20120035447A1
• Time in Patent Office: 1,177 Days
• Field of Search: 600/316, 600/347, 600/365, 600/583
• US Class Current: 600/300
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

A medical device for carrying out at least one medical function. The medical device comprises at least one control part, which can be applied to a body surface of a user, and at least one functional element, which can be inserted into a body tissue of the user at at least one insertion site. The functional element can be connected to the control part. The functional element is designed to carry out at least one medical function. The control part has at least one base part with at least one supporting surface, which faces the body surface. The base part has at least one collection channel for collecting bodily fluid emerging from the insertion site.

Claims

1. A medical device for carrying out at least one medical function, comprising:

a control part which can be applied to a body surface of a user; and

a functional element that is connectable to the control part, the functional element being insertable into body tissue for carrying out a medical function;

wherein, the control part comprises a base part having a support surface configured to face the body surface, the base part comprising at least one collection channel for collecting bodily fluid emerging from the insertion site and conveying excess bodily fluid in a direction substantially parallel to the support surface.

2. The medical device of claim 1, wherein the collection channel is at least partly formed in the support surface.

3. The medical device of claim 1, further comprising at least one fixing element positioned on the support surface for adhering the base part to the body surface.

4. The medical device of claim 3, wherein the fixing element comprises a plaster.

5. The medical device of claim 3, wherein the fixing element at least partly covers the collection channel.

6. The medical device of claim 1, wherein the functional element comprises:

a sensor element for acquiring at least one body state of the user, a sensor element for acquiring at least one analyte in a bodily fluid of the user, an actuator for influencing at least one body state of the user, or a medication device for applying at least one active ingredient into a body tissue of the user.

7. The medical device of claim 1, wherein the collection channel ends at an edge of the supporting surface.

8. The medical device of claim 1, further comprising an opening in the support surface, wherein the functional element is insertable into body tissue through the opening and the collection channel extends away from the opening.

9. The medical device of claim 8, wherein the collection channel extends away from the opening in at least two directions.

10. The medical device of claim 8, wherein the collection channel extends to a border of the support surface.

11. The medical device of claim 1, wherein the collection channel comprises a capillary channel.

12. The medical device of claim 1, wherein the collection channel has a depth direction that is substantially perpendicular to the support surface, the depth of the collection channel being about 0.05 mm to 3 mm.

13. The medical device of claim 12 wherein the collection channel has a depth direction that is substantially perpendicular to the support surface, the depth of the collection channel being about 0.1 mm to 2 mm.

14. The medical device of claim 13, wherein the collection channel has a depth direction that is substantially perpendicular to the support surface, the depth of the collection channel being about 0.2 mm to 1 mm.

15. The medical device of claim 1, wherein the collection channel has a width at its narrowest point of about 0.2 mm to 10 mm.

16. The medical device of claim 15, wherein the collection channel has a width at its narrowest point of about 0.3 mm to 5 mm.

17. The medical device of claim 16, wherein the collection channel has a width at its narrowest point of about 0.5 mm to 2 mm.

18. The medical device of claim 1, wherein the base part has at least one projection extending away from the support surface, wherein the projection forms at least part of at least one sidewall of the collection channel.

19. The medical device of claim 1, wherein the collection channel comprises a depression extending into the support surface.

20. A method of using a medical device of the type having a functional element that is insertable into the skin of a patient, comprising:

providing a control part having a support surface configured to contact a body surface, the support surface having a collection channel;

adhering the support surface to the body surface;

inserting the functional element through an opening in the control part into the body surface;

connecting the functional element to the control part; and

moving bodily fluid that emerges from the body surface away from the opening through the collection channel in a direction substantially parallel to the support surface.

21. The method of claim 20, wherein the step of moving bodily fluid comprises moving the bodily fluid away from the opening through the collection channel in at least two directions.

22. The method of claim 21, further comprising using gravity to move the bodily fluid through the collection channel.

23. The method of claim 20, further comprising using capillary forces to move the bodily fluid through the collection channel.

24. The method of claim 20, comprising at least partially covering the collection channel with a plaster that adheres the support surface to the body surface.

25. The method of claim 20, further comprising collecting bodily fluid with the functional element.

26. The method of claim 25, further comprising analyzing the bodily fluid collected with the functional element for the presence or concentration of an analyte.

27. The method of claim 26, wherein the analyte is glucose and the collecting and analyzing of the bodily fluid is performed at periodic intervals while the control portion remains adhered to the body surface.

28. The method of claim 20, further comprising delivering a medicine through the functional element.

29. A disposable base part for use with a medical device, comprising:

a connector for removably connecting the base part to a re-usable control part;

a support surface;

a fixing element configured to adhere the support surface to a patient'"'"'s skin;

an opening adapted to receive therethrough a functional element configured to be inserted into the patient'"'"'s skin for carrying out a medical function; and

at least one collection channel extending away from the opening, whereby excess bodily fluid emerging from the patient'"'"'s skin can be directed away from the opening through the collection channel in a direction substantially parallel to the support surface.

30. The disposable base part of claim 29, wherein the collection channel extends away from the opening in at least two directions.

31. The disposable base part of claim 29, wherein the fixing element comprises a plaster that at least partially covers the collection channel.

32. The disposable base part of claim 29, wherein the collection channel is dimensioned as a capillary channel.

33. A medical device for carrying out at least one medical function, the device comprising:

a functional element insertable into body tissue for carrying out a medical function; and

a control part adapted to be applied to a body surface of a user, the functional element being connectable to the control part;

wherein the control part comprises a base part having a support surface configured to face the body surface, the support surface defining an opening adapted to receive therethrough the functional element for insertion into body tissue, the support surface further defining an edge forming an outer perimeter of the support surface; and

wherein the support surface further defines at least a portion of at least one collection channel, the at least one collection channel extending away from the opening toward the edge of the support surface wherein the collection channel is adapted to collect excess bodily fluid emerging from the body surface proximate the opening and convey the excess bodily fluid in a direction substantially parallel to the support surface away from the opening.

34. The medical device of claim 33 wherein the support surface includes a depression, the depression defining at least a portion of the at least one collection channel.

35. The medical device of claim 33 further comprising a projection extending outwardly from the support surface and wherein the projection defines at least a part of the collection channel.

36. The medical device of claim 33 wherein the at least one collection channel extends to the edge of the support surface.