Electrode sensor package and application to the skin of a newborn or infant

• US 6,795,722 B2
• Filed: 06/17/2002
• Issued: 09/21/2004
• Est. Priority Date: 06/18/2001
• Status: Active Grant

• Current Assignee: Neotech Products LLC
• Original Assignee: Neotech Products Incorporated
• Inventors: Heyman, Arnold M., McCrary, Craig, Sheraton, David A.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US10/174,908
• Publication Number:
  US 20030009097A1
• Time in Patent Office: 827 Days
• Field of Search: 600/391-393, 607/149, 607/152, 607/153
• US Class Current: 600/391
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61N 1/04 Electrodes electrosurgical electrodes A61B18/14

Abstract

A sensor device in the form of a substantially flat package for receiving and transmitting signals, to be monitored and/or recorded, comprising, in combination a first layer in the form of an annulus having an undersurface to adhere to the skin of a patient; a second layer in the form of a conductive sensing layer peripherally bounded by the first layer and having an undersurface adapted for contact with the skin of the patient; a conductive terminal extending above the second layer in adjacent and conductive relation therewith; a protector extending in shallow dome configuration over the first and second layers and over the terminal; and a conductive lead extending over edges defined by the first and second terminals, and under the protector, for protected contact with the terminal, and to transmit signals for monitoring or recording.

Claims

1. A sensor means in the form of a substantially flat package for receiving and transmitting signals, to be monitored and/or recorded, comprising in combination:

a) a first layer in the form of an annulus having an undersurface to adhere to the skin of a patient,

b) a second layer in the form of a conductive sensing layer peripherally bounded by said first layer and having an undersurface exposed downwardly via a space defined by the first layer and adapted for contact with the skin of the patient,

c) a conductive terminal extending above the second layer in adjacent and conductive relation therewith,

d) a protector extending in shallow dome configuration over said first and second layers and in contact therewith, and over said terminal, as well as over said space.

e) and a conductive lead extending over edges defined by said first and second layers, and under said protector, for protected contact with said terminal.

2. The combination of claim 1 wherein said first layer comprises a hydrocolloid material.

3. The combination of claim 1 wherein said second layer undersurface is spaced above a lower annular surface defined by the first layer.

4. The combination of claim 3 including a strip-off protective layer removably attached to said first layer lower annular surface.

5. The combination of claim 1 wherein said protector has layered configuration.

6. The combination of claim 5 wherein said protector comprises a stack of layers, including:

i) a woven synthetic resin layer,

ii) printed material on the resin layer,

iii) an adhesive layer underlying the resin layer and adherent to peripheral portions of the first and second layers.

7. The combination of claim 1 including instrumentation in electrical communication with said lead, for monitoring or recording electrical signals indicative of each cardiac activity.

8. The combination of claim 1 wherein the dimensions of said first layer are approximately as follows:

9. The combination of claim 8 wherein the dimensions of said second layer are approximately as follows:

10. The combination of claim 9 wherein the dimensions of said protector are approximately as follows:

11. The combination of claim 9 wherein the dimensions of said terminal are approximately as follows:

12. The method of providing and using the package of claim 1 for receiving and transmitting signals, that includes:

a) transmitting manually exerted force to said first layer, via said protective layer to engage said undersurface of the first layer and the skin of a patient,

b) transmitting manually exerted force to said second layer, via said protective layer, to displace a central portion of said second layer undersurface downwardly relative to said first layer to contact the skin of a patient,

c) and sensing signals and transmitting same via said second layer, said terminal and said lead, for monitoring or recording.

13. The method of claim 12 including adhering said protector to peripheral portions of said first and second layers to position them transversely relative to an axis defined by the package.

14. A sensor means in the form of a substantially flat package for receiving and transmitting signals, to be monitored and/or recorded, comprising in combination:

a) a first layer having an undersurface to adhere to the skin of a patient,

b) a second layer in the form of a conductive sensing layer peripherally substantially bounded by said first layer and having an undersurface exposed downwardly for contact with the skin of the patient, and free of the first layer,

c) a conductive terminal extending above the second layer in adjacent and conductive relation therewith,

d) a protector having multiple layers extending in shallow dome configuration directly over and in contact with upper surfaces of said first and second layers and over said terminal, as well as completely over said second layer undersurface,

e) and a conductive lead extending over edges defined by said first and second layers, and under said protector, for protected contact with said terminal.

15. The combination of claim 14, in which said first layer comprises a hydrocolloid material, and said second layer undersurface is spaced above a lower surface defined by the first layer.

16. The combination of claim 14 wherein said protector comprises a stack of layers, including:

i) a woven synthetic resin layer,

ii) printed material on the resin layer,

iii) an adhesive layer underlying the resin layer and adherent to peripheral portions of the first and second layers.

17. The combination of claim 16 including instrumentation in electrical communication with said lead, for monitoring or recording electrical signals indicative of each cardiac activity.

18. A sensor means in the form of a substantially flat package for receiving and transmitting signals, to be monitored and/or recorded, comprising in combination:

a) a first layer in the form of an annulus having an undersurface to adhere to the skin of a patient,

b) a second layer in the form of a conductive sensing layer peripherally bounded by said first layer and having an undersurface exposed downwardly via a space defined by the first layer and adapted for contact with the skin of the patient,

c) a conductive terminal extending above the second layer in adjacent and conductive relation therewith,

d) a protector extending in shallow dome configuration over said first and second layers and in retention therewith, and over said terminal, as well as over said space.

e) and a conductive lead extending over edges defined by said first and second layers, and under said protector, for protected contact with said terminal.