On-body medical device securement

• US 20090088614A1
• Filed: 01/30/2006
• Published: 04/02/2009
• Est. Priority Date: 01/30/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Taub, Marc B.
• Granted Patent: US 7,736,310 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/6833 Adhesive patches

Abstract

Devices and methods for maintaining a medical device on-body are provided. Embodiments include medical device securement systems having first and second on-body securement elements. Also provided are systems and kits for use maintaining a medical device on-body.

Claims

1. An on-body securement element for maintaining a medical device on a body part of a subject, the device comprising:

a member positionable over a medical device and having a surface that includes an adhesive portion and a non adhesive portion, the non adhesive portion configured so that the medical device is not contacted with the adhesive portion when the member is positioned over the medical device.

2. The securement element of claim 1, wherein the non adhesive portion comprises an opening.

3. The securement element of claim 2, wherein the opening comprises a transparent shield.

4. The securement element of claim 2, wherein the adhesive portion is opaque.

5. The securement element of claim 1, wherein the non adhesive portion comprise a pouch.

6. The securement element of claim 1, wherein the adhesive portion is configured for adherence to an adhesive patch on which the medical device is positioned.

7. The securement element of claim 2, wherein the member further comprises at least one release liner adjacent at least the adhesive portion.

8. The securement element of claim 3, wherein the member comprises a release liner system comprising a plurality of release liners.

9. The securement element of claim 1, wherein the surface is disposed on a backing.

10. The securement element of claim 1, further comprising a removable layer adjacent the backing.

11. The securement element of claim 1 wherein the medical device includes one of a control unit, an RF receiver unit, a data monitoring device, an infusion device, or a remote control unit.

12. An on-body securement system for maintaining a continuous analyte monitoring system control unit on a body part of a subject, the system comprising:

a continuous analyte monitoring system control unit;

a first securement element upon which the control unit is positionable; and

a second securement element positionable about the control unit.

13. The system of claim 12, wherein the first element comprises a first surface attachable to skin and a second surface for mating with the control unit.

14. The system of claim 13, wherein the first element comprises:

an adhesive patch; and

a mounting unit connected to the adhesive patch.

15. The system of claim 14, wherein the second element is attachable at least to a portion of the adhesive patch.

16. The system of claim 15, wherein the second element is configured to be positioned around the control unit.

17. The system of claim 16, wherein the second element comprises a control unit opening.

18. The system of claim 15, wherein the second element is configured to be positioned over the control unit.

19. The system of claim 18, wherein the second element comprises a control unit pouch.

20. The system of claim 12, further comprising a plurality of removable layers adjacent a surface of the second element.

21. The system of claim 12, wherein the analyte is glucose.

22. A method for maintaining a control unit of an analyte monitoring system on a body part of a subject, the system comprising:

removably attaching an analyte monitoring system control unit to a body part of a patient; and

positioning an on-body securement element about the control unit.

23. The method of claim 22, wherein attaching comprises mating the control unit to a mounting unit adhesively attached to the body part.

24. The method of claim 22, wherein the on-body securement element includes a control unit hole and the method comprises positioning the hole around the control unit.

25. The method of claim 24, further comprising attaching the on-body securement element to the mounting unit.

26. The method of claim 22, further comprising removing at least one release liner from the on-body securement element.

27. The method of claim 26, comprising removing the at least one release liner prior to positioning the on-body securement element about the control unit.

28. The method of claim 27, wherein the on-body securement element includes a plurality of release liners and the method comprises removing at least one of the remaining release liners after the on-body securement element is positioned about the control unit.

29. The method of claim 22, further comprising controlling a continuous analyte monitoring device with the control unit.

30. The method of claim 29, wherein the analyte is glucose.

31. The method of claim 29, wherein the continuous analyte monitoring device is a glucose sensor, at least a portion of the sensor is positionable under the skin of the subject.