Biopotential sensing device and method for making

• US 4,890,623 A
• Filed: 03/14/1988
• Issued: 01/02/1990
• Est. Priority Date: 03/14/1988
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Cook, William, Sylvanowicz, John, Herman, Jack, Rowe, Donald
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/167,878
• Time in Patent Office: 659 Days
• Field of Search: 128/642, 128/635-641, 128/784-786, 128/419 P, 29/831
• US Class Current: 600/374
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: Y10T 29/49128 Assembling formed circuit to base

Abstract

A printed circuit biopotential sensing device is provided which is particularly adapted for endocardial or other deep body applications. The device has a predetermined printed circuit pattern formed on a thin film substrate, the pattern having at least one electrode pad at its distal end, at least one terminal pad at the proximal end, and conductor means selectively interconnecting the electrode pads and terminal pads. The substrate is secured to, and is preferably wrapped around an elongated member which is preferably tube-shaped in a manner such that the electrodes are exposed at the distal end of the member, and the terminal pads at the proximal end of the substrate are utilized in forming a suitable connector from the device. By forming the conductors on only a selected fraction of the width of the substrate and overlapping the portion of the substrate containing the conductors during the helical wrapping process, the substrate insulates and protects the conductors and eliminates the need for a separate protective layer. The device may, for example, be a percutaneous catheter with the electrodes being formed at the distal end thereof, or may be a sensing probe which includes a sensing support member, such as a solid plastic member or a balloon which has the distal end of the substrate containing the electrode pads secured thereto.

Claims

1. A biopotential sensing device comprising:

a thin flexible substrate having a proximal end and a distal end;

a predetermined printed circuit pattern formed on said substrate, said pattern having at least one electrode pad at its distal end, at least one terminal pad at its proximal end and conductor means selectively interconnecting said electrode pads and said terminal pads;

an elongated support member; and

means for mounting and securing said substrate to said support member, said means causing the covering of said conductor means while leaving said electrode pads and said terminal pads exposed.

2. A device as claimed in claim 1 wherein said support member is an elongated tube-shaped member;

and

wherein said means for mounting and securing includes means for wrapping said substrate around said tube-shaped member.

3. A device as claimed in claim 2 wherein said substrate is helically wrapped around the outside of said tube-shaped member.

4. A device as claimed in claim 3 wherein said conductor means are formed on only a selected fraction of the width of said substrate;

and

wherein said helical wrapping includes overlapping the portion of the substrate containing said conductor means during each helical wrap, whereby the substrate serves to insulate the conductor means.

5. A device as claimed in claim 3 wherein said electrode pads are formed at an angle to the conductor means such that, when said substrate is helically wrapped around said support member, said electrodes form concentric parallel rings around the support member.

6. A device as claimed in claim 2 including means for applying adhesive to the back of the substrate, the adhesive causing said substrate to be secured to said support member as it is wrapped thereon.

7. A device as claimed in claim 2 including at least one lumen formed through said tube-shaped member.

8. A device as claimed in claim 1 wherein at least one of said electrode pads is a means for both applying a potential and for sensing a potential.

9. A device as claimed in claim 1 wherein said device is of a given length which is sufficient to reach the heart or other organs deep within the body

wherein said support member is an elongated tube-shaped member of substantially said given length;

and

wherein said means for mounting and securing includes means for wrapping the substrate around said tube-shaped member.

10. A device as claimed in claim 9 wherein said substrate is helically wrapped around said tube-shaped member.

11. A device as claimed in claim 9 wherein said tube-shaped member has at least one lumen formed therethrough.

12. A device as claimed in claim 1 wherein each of said terminal pads has a hole formed therein;

and including a connector pin inserted in at least selected ones of said holes.

13. A device as claimed in claim 12 including means for physically and electrically connecting each connector pin to the associated terminal pad.

14. A device as claimed in claim 12 including means for selectively electrically connecting said terminal pads whereby encoded information concerning said device may be provided.

15. A device as claimed in claim 12 wherein said support member is an elongated tube-shaped member having a proximal end and a distal end;

wherein said means for mounting and securing includes means for helically wrapping the substrate around said tube-shaped member, the portion of said substrate having said terminal pads printed thereon extending at an angle from a point near the proximal end of the tube-shaped member; and

including

at least one lumen extending through the tube-shaped member; and

a bifurcated fitting molded to the proximal end of said tube-shaped member to provide access to said lumen and molded to the extending portion of said substrate and the connector pins to form an electrical connector for said device.

16. A device as claimed in claim 1 wherein said device is a sensing probe;

and

including a sensor support member, and means for securing the distal end of said substrate containing said at least one electrode pad to said sensor support member.

17. A device as claimed in claim 16 wherein said sensor support member is a solid plastic member having a predetermined shape.

18. A device as claimed in claim 16 wherein said sensor support member is a balloon.

19. A device as claimed in claim 1 wherein said predetermined printed circuit pattern is formed on both sides of said substrate, and wherein said printed circuit pattern includes means for interconnecting the patterns formed on each side.

20. A device as claimed in claim 19 wherein said means for interconnecting includes at least one plated through hole.

21. A method for fabricating a biopotential sensing device comprising the steps of:

forming a predetermined printed circuit pattern on a thin film substrate, the pattern having at least one electrode pad at a distal end of the substrate, at least one terminal pad at a proximal end of the substrate, and conductor means selectively interconnecting the electrode pads and terminal pads;

mounting the substrate to an elongated support member and securing the substrate thereto, said mounting and securing step involving wrapping at least a portion of the substrate around at least a portion of said elongated member, and being performed in a manner such as to cover said conductor means while leaving at least a portion of each electrode pad exposed at a distal end of the elongated member; and

utilizing the terminal pads to form a connector means, permitting the device to be connected to external circuitry.

22. A method as claimed in claim 21 wherein said mounting step includes helically wrapping said substrate about said elongated member.

23. A method as claimed in claim 22 wherein said conductor means are formed on only a selected fraction of the width of said substrate;

and

wherein said helical wrapping step includes the step of overlapping the portion of the substrate containing the conductor means during each helical wrap, whereby the substrate serves to insulate the conductor means.

24. A method as claimed in claim 21 wherein said device is a sensing probe;

and including the step of securing the distal end of the substrate containing the at least one electrode pad to a sensor support member.