Medical device with a packaged electronic subassembly and method for fabricating the same

Patent metadata

Field	Value
Publication number	US-10548671-B2
Application number	US-201515114011-A
Country	US
Kind code	B2
Filing date	Jan 27, 2015
Priority date	Jan 28, 2014
Publication date	Feb 4, 2020
Grant date	Feb 4, 2020

Abstract

A medical device for the diagnosis or treatment of tissue in a body and method for fabricating the same are provided. The device includes an elongate, tubular, deformable shaft comprising a proximal end and a distal end. The device also includes an electronic subassembly (54) disposed within the shaft and a conductor (76, 78) coupled to and extending from the electronic subassembly. The electronic subassembly includes a flexible substrate (72) and an electronic device (74). The flexible substrate comprises an interior side (84) and an exterior side (86) opposite the interior side. The flexible substrate also defines a first conductive area (92, 94). The electronic device is mounted on the interior side of the flexible substrate, is coupled to the first conductive area, and is at least partially enclosed within the flexible substrate.

First claim

What is claimed is:

1. A medical device for diagnosis or treatment of tissue in a body, comprising:
an elongate, tubular, deformable shaft comprising a proximal end and a distal end;
an electronic subassembly disposed within said shaft, said electronic subassembly including
a flexible substrate comprising an interior side and an exterior side opposite said interior side, said flexible substrate defining a first conductive area; and
an electronic device mounted on said interior side of said flexible substrate and coupled to said first conductive area, said electronic device at least partially enclosed within said flexible substrate;
a conductor coupled to and extending from said electronic subassembly; and
wherein said flexible substrate is cylindrical in shape and circumferentially surrounds said electronic device, and said shaft is deformable along an entire length between the distal end and the proximal end.

2. The device of claim 1 , wherein said electronic device is an electromagnetic field detector.

3. The device of claim 2 wherein said electromagnetic field detector comprises a coil defined by a continuous wire element disposed in a helix.

4. The device of claim 3 wherein said electromagnetic field detector further comprises a core, said coil wound about said core.

5. The device of claim 1 wherein said first conductive area is on said interior side of said flexible substrate, said electronic subassembly further includes a second conductive area on said exterior side and a first conductive path between said first and second conductive areas, and said conductor is coupled to said second conductive area.

6. The device of claim 5 wherein said first and second conductive areas are disposed at a proximal end of said flexible substrate.

7. The device of claim 1 wherein said electronic subassembly is encapsulated by an encapsulant.

8. The device of claim 7 wherein first conductive area is on said interior side of said flexible substrate and said electronic subassembly further includes a second conductive area on said exterior side and is exposed through said encapsulant for connection to said conductor.

9. A medical device for diagnosis or treatment of tissue in a body, comprising:
an elongate, tubular, deformable shaft comprising a proximal end and a distal end;
an electronic subassembly disposed within said shaft, said electronic subassembly including
a flexible substrate comprising an interior side and an exterior side opposite said interior side, said flexible substrate defining a first conductive area; and
an electronic device mounted on said interior side of said flexible substrate and coupled to said first conductive area, said electronic device at least partially enclosed within said flexible substrate;
a conductor coupled to and extending from said electronic subassembly; and
wherein said electronic device is an electromagnetic field detector, and said shaft is deformable along an entire length between the distal end and the proximal end.

10. The device of claim 9 wherein said electromagnetic field detector comprises a coil defined by a continuous wire element disposed in a helix.

11. The device of claim 10 wherein said electromagnetic field detector further comprises a core, said coil wound about said core.

12. The device of claim 9 wherein said first conductive area is on said interior side of said flexible substrate, said electronic subassembly further includes a second conductive area on said exterior side and a first conductive path between said first and second conductive areas, and said conductor is coupled to said second conductive area.

13. The device of claim 12 wherein said first and second conductive areas are disposed at a proximal end of said flexible substrate.

14. The device of claim 9 wherein said electronic subassembly is encapsulated by an encapsulant.

15. The device of claim 14 wherein first conductive area is on said interior side of said flexible substrate and said electronic subassembly further includes a second conductive area on said exterior side and is exposed through said encapsulant for connection to said conductor.

16. A method for fabricating a medical device for diagnosis or treatment of tissue in a body, comprising:
providing a flexible substrate comprising an interior side and an exterior side opposite said interior side and first and second edges extending between said interior and exterior sides, said flexible substrate defining a first conductive area;
mounting an electronic device on said interior side of said flexible substrate and coupling said electronic device to said first conductive area;
deforming said flexible substrate so as to at least partially enclose said electronic device;
inserting said flexible substrate into an elongate, tubular, deformable shaft comprising a proximal end and a distal end, the deformable shaft being deformable along an entire length between the distal and proximal ends;
electrically coupling a conductor to said electronic device;
coupling said first and second edges of said flexible substrate to one another to at least partially enclose said electronic device within said flexible substrate; and
wherein said coupling said first and second edges includes
applying an adhesive to said first edge of said flexible substrate,
overlapping said second edge of said flexible substrate with said first edge such that at least a portion of said second edge contacts said adhesive, and
curing said adhesive.

17. The method of claim 16 wherein said deforming comprises moving said first and second edges of said flexible substrate closer to one another.

18. The method of claim 16 , wherein said electronic device comprises a coil and said mounting comprises electrically connecting said coil of said electronic device to said first conductive area.

19. The method of claim 16 , wherein said deforming comprises deforming said flexible substrate about a longitudinal axis of said electronic device.

20. The method of claim 16 , wherein said deforming comprises deforming said flexible substrate into a cylindrical shape.

21. The method of claim 16 , wherein said first conductive area is disposed on said interior side of said flexible substrate.

22. The method of claim 16 , wherein said flexible substrate includes a second conductive area on said exterior side of said flexible substrate and a first conductive path between said first and second conductive areas, said first conductive area disposed on said interior side of said flexible substrate, and electrically coupling said conductor to said electronic device comprises electrically coupling said conductor to said second conductive area.

23. The method of claim 16 , further comprising encapsulating said flexible substrate and said electronic device with an encapsulant.

24. The method of claim 23 , further comprising ablating said encapsulant to expose said second conductive area on said flexible substrate for connection to said conductor.

25. A method for fabricating a medical device for diagnosis or treatment of tissue in a body, comprising:
providing a flexible substrate comprising an interior side and an exterior side opposite said interior side and first and second edges extending between said interior and exterior sides, said flexible substrate defining a first conductive area;
mounting an electronic device on said interior side of said flexible substrate and coupling said el

Assignees

• St Jude Medical Int Holding Sarl

Inventors

• Sterrett Terry L
• Senarith Patrick P

Classifications

• A61B18/1492

  having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence) · CPC title

• A61B34/20 Primary

  Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis · CPC title

• A61B2562/164

  the sensor is mounted in or on a conformable substrate or carrier · CPC title

• A61B5/0538

  invasively, e.g. using a catheter · CPC title

• A61B5/062

  using magnetic field · CPC title