Devices, systems and methods for on-skin or on-body mounting of medical devices

• US 9,572,534 B2
• Filed: 06/28/2011
• Issued: 02/21/2017
• Est. Priority Date: 06/29/2010
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Liu, Chu Chuan (J J)
• APPLICATION: US 20110319733A1
• Time in patent office: 2065 Days
• Field of Search: 600/309, 600/310, 600/322, 600/342, 600/344, 600/345, 600/347, 600/365, 600/473, 600/476
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

Devices, systems, methods and kits for releasably mounting a medical device on the body or skin of a user are provided.

Claims

1. A holder apparatus for holding an on-body medical device, the on-body medical device having an enclosure housing one or more electronic components, the holder apparatus comprising:

a support body having a bottom portion configured to contact the skin of the user of the medical device, and a top portion to operably mount the enclosure of the medical device, wherein the support body comprises;

a first portion; and

a second portion moveable relative to the first portion;

wherein the first and second portion of the support body interpose the enclosure of the medical device and the skin of the user, wherein at least the first portion is attachable to the skin of the user, and wherein the top portion of at least the first portion being configured to engage the enclosure of the medical device to hold the medical device in place on the support body,

wherein the first and second portions having a medical device holding state in which the first and second portions are linearly aligned with respect to each other along the skin of the user of the medical device while at least the first portion is engaged with the enclosure of the medical device to hold the medical device in place on the support body,

wherein movement of the second portion of the support body relative to the first portion of the support body and the enclosure of the medical device when the first portion is attached to the skin of the user and engaged with the enclosure of the medical device causes the first and second portions of the support body to transition to a medical device release state in which the first and second portions of the support body are linearly misaligned or offset with respect to each other and at least a portion of the enclosure of the medical device is released from the second portion of the support body while the enclosure of the medical device remains engaged with the first portion and operatively mounted on the support body.

2. The apparatus of claim 1, further comprising a third portion extending between the first and second portions, wherein the third portion is configured to be alterable from a first state to a second state to provide the movement of the second portion relative to the first portion.

3. The apparatus of claim 2, wherein the third portion is one of breakable, bendable, frangible or one or more combinations thereof.

4. The apparatus of claim 2, wherein the third portion comprises one or more of a reduced mass, a reduced thickness, a weakened area, a detent, a hinge, a fracture point or scoring.

5. The apparatus of claim 2, wherein the third portion is returnable to the first state upon being altered to the second state.

6. The apparatus of claim 2, wherein the third portion is not returnable to the first state upon being altered to the second state.

7. The apparatus of claim 1, wherein the relative movement comprises one or more of linear, axial and angular displacement.

8. The apparatus of claim 1, further comprising at least one feature for releasably coupling with a corresponding at least one feature of the medical device.

9. The apparatus of claim 1, wherein the first and second portions including a first surface configured to operably mount a bottom surface of the medical device.

10. The apparatus of claim 9, wherein the first and second portions including a second surface for placement on a skin surface, wherein the first and second surfaces are on opposing sides of the first and second portions.

11. The apparatus of claim 10, wherein the second surface comprises an adhesive.

12. The apparatus of claim 1, wherein the first portion comprises an abutment for retaining the medical device.

13. The apparatus of claim 1, further comprising an aperture within one of the first and second portions for receiving an implantable component of the medical device.

14. The apparatus of claim 13, wherein the aperture enables electrical contact between the implantable component and another component of the medical device.

15. The apparatus of claim 1, wherein movement of the second portion relative to the first portion further causes at least initiating movement of the medical device in a release direction from the first portion.

16. An on-body medical device assembly comprising:

a medical device having a housing and one or more electronic components positioned within the housing; and

a mounting unit adapted for mounting on a skin surface of a user of the medical device and for releasably retaining the housing of the medical device on the mounting unit,

wherein the mounting unit comprises a support body having a bottom portion configured to contact the skin of the user of the medical device, and a top portion to operably mount the housing of the medical device, the support body comprising a main portion and a displaceable portion, wherein each of the main and displaceable portions interposes the housing of the medical device and the skin of the user, wherein at least the main portion is attachable to the skin surface, and wherein the top portion of at least the main portion is configured to engage the medical device housing to hold the medical device in place on the support body,

wherein the main and displaceable portions having a first state in which the main and displaceable portions are linearly aligned with respect to each other along the skin of the user of the medical device while at least the first portion is engaged with the medical device housing to hold the medical device housing in place on the support body, and

wherein displacement of the displaceable portion of the support body relative to the main portion of the support body and the medical device housing of the medical device when the main portion is attached to the skin surface of the user and engaged with the medical device housing causes the main and displaceable portions of the support body to transition to a second state in which the main and displaceable portions of the support body are linearly misaligned or offset with respect to each other and at least a portion of the medical device housing is released from the displaceable portion of the support body of the mounting unit while the medical device housing remains engaged with the main portion and operatively mounted on the support body.

17. The assembly of claim 16, wherein the displacement provided by the displaceable portion comprises one or more of linear, axial and angular movement.

18. The assembly of claim 17, wherein the displaceable portion is configured to be displaced by a low-force pressure against the displaceable portion in a direction away from the medical device.

19. The assembly of claim 16, wherein the medical device includes a feature for releasably coupling with a corresponding feature of the mounting unit.

20. The assembly of claim 19, wherein the displacement of the displaceable portion of the mounting unit decouples the corresponding feature of the mounting unit and the medical device.

21. The assembly of claim 20, wherein the medical device comprises a second feature for releasably coupling with a corresponding second feature of the mounting unit, wherein the displacement of the displaceable portion of the mounting unit does not decouple the second corresponding feature of the mounting unit and the medical device.

22. The assembly of claim 16, wherein the main and displaceable portions of the mounting unit have a top surface to operably mount a bottom surface of the medical device housing and a bottom surface for placement on the skin surface.

23. The assembly of claim 22, wherein the bottom surface of the mounting unit comprises an adhesive material.

24. The assembly of claim 22, wherein the top surface of the mounting unit comprises at least one feature for releasably coupling to a corresponding feature of the medical device.

25. The assembly of claim 24, wherein the at least one feature of the mounting unit is at least one rail and the at least one feature of the medical device is at least one groove.

26. The assembly of claim 24, wherein the at least one feature of the mounting unit is a receptacle and the at least one feature of the medical device is a tab.

27. The assembly of claim 16, wherein displacement of the displaceable portion further causes at least initiating movement of the medical device in a release direction from the main portion.

36. The assembly of claim 16, further including an analyte sensor coupled to the medical device housing, the analyte sensor including a plurality of electrodes, wherein the plurality of electrodes include a working electrode comprising an analyte-responsive enzyme and a mediator, wherein at least one of the analyte responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein the at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

28. A method of using an on body medical device, the method comprising:

mounting a medical device on a skin surface of a user with a mounting unit, the medical device having a housing and one or more electronic components positioned within the housing, the mounting unit comprising a support body having a bottom portion configured to contact the skin of the user of the medical device, and a top portion to operably mount the housing of the medical device, the support body including first and second portions, wherein each of the first and second portions of the support body interposes the housing of the medical device and the skin of the user, wherein at least the first portion is attachable to the skin surface, and wherein the top portion of at least the first portion is configured to engage the housing of the medical device to hold the medical device in place on the support body;

operatively using the medical device for a predetermined period of time; and

displacing the second portion of the mounting unit relative to the housing of the medical device and the first portion of the mounting unit when the first portion is attached to the skin of the user and engaged with the housing of the medical device transitioning the first and second portions from a first position in which the first and second portions are linearly aligned with respect to each other along the skin of the user of the medical device while at least the first portion is engaged with the housing of the medical device to hold the medical device in place on the support body, to a second position in which the first and second portions of the support body are linearly misaligned or offset with respect to each other, wherein displacing the second portion of the support body relative to the first portion of the support body and the housing of the medical device when the first portion is attached to the skin and engaged with the housing of the medical device releases at least a portion of the housing of the medical device from the second portion of the support body of the mounting unit while the housing of the medical device remains engaged with the first portion and operatively mounted on the support body.

29. The method of claim 28, further comprising:

replacing at least one component of the medical device;

returning the displaced second portion of the mounting unit to the first position; and

operatively reusing the medical device for the predetermined period of time.

30. The method of claim 29, wherein the medical device is an analyte monitoring device comprising an electronics unit having a low-profile housing, and a plurality of at least partially implantable analyte sensors, each sensor being usable for the predetermined period of time, wherein the mounting unit enables electrical coupling between the electronics unit and one of the plurality of analyte sensors.

31. The method of claim 28, further comprising:

removing the medical device from the mounting unit;

replacing at least one component of the medical device;

mounting the medical device on the skin surface with a second mounting unit affixed to a second location on the skin surface; and

operatively reusing the medical device for the predetermined period of time.

32. The method of claim 31, wherein the medical device is an analyte monitoring device comprising an electronics unit having a low-profile housing, and a plurality of at least partially implantable analyte sensors, each sensor being usable for the predetermined period of time, wherein the mounting unit enables electrical coupling between the electronics unit and one of the plurality of analyte sensors.

33. The method of claim 28, wherein displacing the first portion of the mounting unit relative to the second portion comprises one or more of linear, axial and angular movement.

34. The method of claim 28, wherein displacing the second portion of the mounting unit relative to the second portion and the medical device comprises applying a low force pressure against the second portion in a direction away from the medical device.

35. The method of claim 28, wherein releasing at least a portion of the medical device from the second portion of the mounting unit comprises decoupling a mating feature of the mounting unit from a corresponding mating feature of the medical device.

37. The method of claim 28, wherein the analyte sensor includes a plurality of electrodes, wherein the plurality of electrodes include a working electrode comprising an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein the at least one of the analyte responsive enzyme and the mediator is crosslinked with the polymer.

38. The method of claim 28, wherein displacing the second portion of the mounting unit relative to the first portion of the mounting unit from the first position to the second position further comprising at least initiating movement of the medical device in a release direction from the first portion.