Multi-electrode sensing patch for long-term physiological monitoring with swappable electronics, radio and battery, and methods of use

• US 9,265,435 B2
• Filed: 10/21/2008
• Issued: 02/23/2016
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: HMicro Inc.
• Original Assignee: HMicro Inc.
• Inventors: Beck, James C.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US12/739,553
• Publication Number:
  US 20110028822A1
• Time in Patent Office: 2,681 Days
• Field of Search: 439345-347, 439/909, 600/372, 600/382, 600/384, 600/386, 600392-393, 600508-509, 607/46, 607/48, 607/50, 607/72, 607/115
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/296 for electromyography [EMG]

Abstract

Provided herein is an electrode device comprising an interface comprising at least one magnetic contact. The interface can be adaptable to be in communication with an electronic member, wherein the magnetic contact on the interface is adaptable to align and position the electronic member with respect to the interface. The interface can be further adaptable to remain affixed to a patient while an electronic member is removed and/or inserted from the interface. Further provided herein are methods of using the electrode device and kits.

Claims

1. An electrode device comprising:

a pouch formed of a flexible substrate having a first part and a second part that are inseparably joined together along a periphery, the pouch having an interior and comprising at least one electrode contact area on a surface of the first part and at least one contact patch on an interior surface of the second part, the at least one electrode contact area connected to the at least one contact patch via a conductive trace traversing a distance along the flexible substrate over both the first part of the pouch and the second part of the pouch, the at least one contact patch overlying at least one magnetic contact, the pouch adaptable to be in communication with an electronic member through the at least one contact patch and accept the electronic member within its interior between the first part and the second part of the flexible substrate without disturbing the pouch, the at least one magnetic contact adaptable to slidably align and position the electronic member within the interior of the pouch.

2. The device of claim 1 wherein the pouch is further adaptable to remain affixed to a patient while the electronic member is removed and/or inserted from the interior of the pouch.

3. The device of claim 1 wherein the electronic member comprises a corresponding magnetic contact and the device further comprises the electronic member within the interior of the pouch such that the at least one magnetic contact of the pouch aligns with the corresponding magnetic contact of the electronic member.

4. The device of claim 1 wherein the at least one magnetic contact of the pouch is a ferromagnetic material and the corresponding magnetic contact of the electronic member is a magnet.

5. The device of claim 3 wherein the at least one magnetic contact of the pouch adaptably aligns with the corresponding magnetic contact of the electronic member to cause the contact patch of the pouch overlying the at least one magnetic contact to directly contact a contact located on the electronic member, such that the contact patch of the pouch and the contact located on the electronic member are sandwiched between the at least one magnetic contact of the pouch and the corresponding magnetic contact of the electronic member.

6. The device of claim 1 wherein the device is adaptable to be used with a replaceable electronic member.

7. The device of claim 1 further comprising a ferromagnetic metal adaptable to facilitate a magnetic connection between the pouch and the electronic member.

8. The device of claim 7 wherein the pouch is adaptable to maintain the connection between the electronic member and the pouch.

9. The device of claim 1 further comprising an additional support structure adaptable to maintain the position of the electronics component.

10. The device of claim 1 wherein the at least one magnetic contact is adaptable to provide a low engagement force between the pouch and the electronic member.

33. The device of claim 1 wherein the substrate is a single integral flexible piece, and the first part and the second part are folded together along a hinge and the conductive trace traverses the first part and the second part through the hinge.

34. The device of claim 33 wherein the first part comprises gel contact areas and electrode contact areas configured to contact a patient'"'"'s skin.

35. The device of claim 33 wherein the second part is at least half the size of the first part.

11. An electrode device comprising:

a pouch in communication with a patient, said pouch formed from a flexible substrate having a first flexible part and a second flexible part that are inseparably joined together along a periphery, said pouch having an interior, wherein the pouch comprises a conductive trace traversing a distance along the flexible substrate over both the first flexible part and the second flexible part; and

an electronic member adaptable to be slidably inserted and/or removed from the interior of the pouch between the first flexible part and the second flexible part without disturbing the pouch including the joined periphery;

wherein the pouch is adaptable to slidably engage the electronic member and further adaptable to facilitate self-alignment and self-positioning of the electronic member within the interior of the pouch.

12. The device of claim 11 further comprising at least one magnetic contact located on the pouch, the contact adaptable to facilitate the self-alignment and self-positioning of the electronic member.

13. The device of claim 11 wherein the electronic member is adaptable to be slidably inserted, removed, and then reinserted into the interior of the pouch without disturbing the pouch.

14. The device of claim 11 wherein the electronic member is adaptable to be slidably inserted, removed, and replaced with a second electronic member without disturbing the pouch.

20. The method of claim 14 wherein the device is adaptable to facilitate insertion of the electronic member in the pouch.

36. The device of claim 11 wherein the substrate is a single flexible integral piece and the first part and the second part are folded together along a hinge.

37. The device of claim 36 wherein the first part comprises electrode contact areas configured to contact the patient'"'"'s skin and the second part comprises a second set of contact patches.

38. The device of claim 37 wherein electrode contact areas are electronically connected to the second set of contact patches via one or more traces that traverse the first and second part through the hinge.

39. The device of claim 37 wherein the second part comprises one or more ferromagnetic disks.

40. The device of claim 39 wherein the electronic member comprises a magnet, and the one or more ferromagnetic disks bring the second set of contact patches together with one or more contacts of the electronic member, thereby completing a circuit.

41. The device of claim 11 wherein the first part and the second part are inseparably joined together along the periphery through an adhesive or thermal bonding.

15. A method for detecting a physiological parameter with at least one electrode comprising:

positioning a pouch on a surface of a patient, wherein the pouch is formed from a flexible substrate having a first part and a second part that are inseparably joined together along a periphery, the pouch having an interior and comprising a conductive trace traversing a distance along the flexible substrate over both the first part and the second part;

sliding an electronic member into contact with the pouch between the first part and the second part of the flexible substrate to engage the electronic member with the pouch; and

detecting the physiological parameter from the patient.

16. The method of claim 15 wherein the electronics member is adaptable to be inserted and/or removed from the pouch without disturbing the pouch.

17. The method of claim 15 further comprising the step of removing the electronic member from the pouch and replacing the electronic member with a second electronic member.

18. The method of claim 17 wherein the second electronic member is the electronic member.

19. The method of claim 15 wherein the pouch comprises at least one magnetic contact, the pouch adaptable to be in communication with the electronic member, wherein the at least one magnetic contact is adaptable to align and position the electronic member in the pouch.

21. A method of detecting a physiological parameter comprising:

forming a pouch from a flexible substrate having a first part and a second part that are inseparably joined together along a periphery, the pouch having an interior and comprising a conductive trace traversing a distance along the flexible substrate over both the first part and the second part, the flexible substrate comprising at least one magnetic contact;

contacting the pouch with a surface of a patient;

inserting an electronic member in the pouch between the first part and the second part of the flexible substrate, the electronic member comprising at least one magnetic contact;

connecting the pouch and electronic member using the at least one magnetic contact on the pouch and the at least one contact on the electronic member; and

detecting at least one physiological parameter from the patient.

22. The method of claim 21 wherein the pouch is further adaptable to remain affixed to a patient while the electronic member is removed and/or inserted from the pouch.

23. The method of claim 21 further comprising the step of disconnecting the electronic member from the pouch and reconnecting the electronic member with the pouch.

24. The method of claim 21 further comprising the step of disconnecting the electronic member from the pouch and reconnecting a new electronic member with the pouch.

25. A method for detecting a physiological parameter from a patient comprising:

sliding an electronic member into contact with a pouch adaptable to be in communication with the electronic member, wherein the pouch is formed from a flexible substrate having a first part and a second part that are inseparably joined together along a periphery, said pouch having an interior and comprising a conductive trace traversing a distance along the flexible substrate over both the first part and the second part and wherein the electronic member is positioned between the first part and the second part of the flexible substrate; and

positioning the pouch on a surface of a patient.

26. The method of claim 25 wherein the pouch is further adaptable to remain affixed to a patient while the electronic member is removed and/or inserted from the pouch.

27. The method of claim 25 further comprising the step of removing the electronic member and reinserting the electronic member.

28. The method of claim 25 further comprising the step of removing the electronic member and replacing the electronic member with a second electronic member.

29. A kit for measuring a physiological parameter comprising:

a pouch formed from a flexible substrate having a first part and a second part that are joined together along a periphery, said pouch having an interior and comprising (1) a conductive trace traversing a distance along the flexible substrate over both the first part and the second part and (2) at least one magnetic contact, wherein the pouch is adaptable to be in communication with an electronic member, and wherein the at least one magnetic contact is adaptable to slidably engage the electronics member and is further adaptable to align and position the electronic member in the pouch between the first part and the second part of the flexible substrate.

30. The kit of claim 29 further comprising the electronic member.

31. A kit for measuring a physiological parameter comprising:

a pouch formed from a flexible substrate having a first part and a second part that are inseparably joined together along a periphery, said pouch having an interior and comprising (1) a conductive trace traversing a distance along the flexible substrate over both the first part and the second part and (2) at least one magnetic contact, wherein the pouch adaptable to be in communication with an electronic member; and

at least one electronic member adaptable to be inserted and/or removed from the pouch interface without disturbing the pouch,

wherein the at least one magnetic contact is adaptable to slidably align and position the electronic member in the pouch between the first part and the second part of the flexible substrate.

32. The kit of claim 31 further comprising more than one electronic member.