Device for catheter-based electrophysiology

Abstract

To provide a flexible circuit strip for use in catheter assemblies. [Solution] The flexible circuit strip comprises a first insulating layer, a second insulating layer, and a third insulating layer, each having an elongated shape and joined to each other such that the second insulating layer is between the first insulating layer and the third insulating layer; a conductive trace layer positioned between the first insulating layer and the second insulating layer, the conductive trace layer including a longitudinal circuit trace for carrying electrical signals; electrodes positioned along the length of the outer surface of the first insulating layer and electrically connected to the circuit trace; and a longitudinal hollow channel formed between any two of the first, second, and third layers, the longitudinal hollow channel configured to receive an elongated support element.

Claims

1. A flexible circuit strip for use in catheter assemblies, (a) A first insulating layer, a second insulating layer, and a third insulating layer, each having an elongated shape, and joined to each other such that the second insulating layer is located between the first insulating layer and the third insulating layer, (b) A conductive trace layer positioned between the first insulating layer and the second insulating layer, wherein the conductive trace layer includes a longitudinal circuit trace for transporting electrical signals, (c) An electrode positioned along the length of the outer surface of the first insulating layer and electrically connected to the circuit trace, (d) A flexible circuit strip comprising a longitudinal hollow channel formed between any two of the first layer, the second layer, and the third layer, wherein the longitudinal hollow channel is configured to receive an elongated support element.

2. The flexible circuit strip according to claim 1, further comprising a contact array positioned at the proximal end of the outer surface of the first insulating layer, wherein the electrodes are connected to the contact array using circuit traces.

3. The flexible circuit strip according to claim 2, wherein the connection between the circuit trace and the electrode is established via vias extending through the first insulating layer.

4. The flexible circuit strip according to claim 1, wherein each electrode is covered by an insulating cover having one or more openings, and the insulating cover is positioned above the electrode so as to expose a selected portion of the electrode.

5. The flexible circuit strip according to claim 1, wherein the electrodes and the circuit traces include gold.

6. The flexible circuit strip according to claim 1, wherein the first insulating layer, the second insulating layer, and the third insulating layer each contain polyimide.

7. The flexible circuit strip according to claim 1, wherein the conductive trace layer contains gold.

8. The flexible circuit strip according to claim 1, wherein the first insulating layer is thicker than the second insulating layer and the third insulating layer.

9. An expandable end effector for use in catheter assemblies, (a) Spline holding hub and (b) An expandable basket assembly connected to the spline retaining hub, the expandable basket assembly includes one or more flexible splines configured to deflect radially outward from a folded state connected to the spline retaining hub to an expanded state, each flexible spline is iii. Flexible circuit strip, - A first insulating layer, a second insulating layer, and a third insulating layer, each having an elongated shape, and joined to each other such that the second insulating layer is located between the first insulating layer and the third insulating layer, - A conductive trace layer positioned between the first insulating layer and the second insulating layer, wherein the conductive trace layer includes a longitudinal circuit trace for transporting electrical signals, - An electrode positioned along the length of the outer surface of the first insulating layer and electrically connected to the circuit trace, A flexible circuit strip comprising: a longitudinal hollow channel formed between any two of the first insulating layer, the second insulating layer, and the third insulating layer, wherein the longitudinal hollow channel is configured to receive an elongated support element; iv. An expandable end effector comprising an expandable basket assembly comprising an elongated support element disposed within the vertical hollow channel, and an expandable end effector.

10. The expandable end effector according to claim 9, wherein the elongated support element is arranged to have play within the longitudinal hollow channel, allowing for longitudinal adjustment therein.

11. The expandable end effector according to claim 9, wherein the elongated support element is fixed within the longitudinal hollow channel.

12. The expandable basket assembly comprises a first flexible spline, the first flexible spline having a proximal end connected to the spline holding hub and a distal end connected to the distal end of a second flexible spline, according to claim 9.

13. The expandable end effector according to claim 9, further comprising a pusher coaxially disposed within the spline holding hub and configured to translate relative to the spline holding hub along the longitudinal axis of the hub, wherein each of the one or more flexible splines has a proximal end connected to the spline holding hub and a distal end connected to the distal end of the pusher, and the one or more flexible splines are configured to deflect radially outward when the pusher is retracted relative to the spline holding hub, thereby expanding the expandable basket assembly from a folded state to an expanded state.

14. The expandable end effector according to claim 9, wherein one or more flexible splines are configured to deflect radially outward when radial constraints are released.

15. The expandable end effector according to claim 14, wherein the one or more flexible splines comprises a proximal end and a distal end, and both the proximal end and the distal end are connected to the spline holding hub.

16. The expandable end effector according to claim 9, comprising a plurality of flexible splines that form a basket in the expanded form.

17. The expandable end effector according to claim 9, wherein the elongated support element is fitted into the longitudinal hollow channel and loosely secured using adhesive to allow for longitudinal play.

18. The expandable end effector according to claim 9, wherein the elongated support element includes shape-setting nitinol.

19. A catheter assembly, - A tubular shaft, the tubular shaft extending along a longitudinal axis that extends from the proximal portion of the tubular shaft to the distal portion of the tubular shaft, - An expandable end effector, (a) A spline retaining hub connected to the distal portion of the tubular shaft, (b) An expandable basket assembly connected to the spline retaining hub, the expandable basket assembly includes one or more flexible splines configured to deflect radially outward from a folded state connected to the spline retaining hub to an expanded state, each flexible spline is i. A flexible circuit strip, - A first insulating layer, a second insulating layer, and a third insulating layer, each having an elongated shape, and joined to each other such that the second insulating layer is located between the first insulating layer and the third insulating layer, - A conductive trace layer positioned between the first insulating layer and the second insulating layer, wherein the conductive trace layer includes a longitudinal circuit trace for transporting electrical signals, - An electrode positioned along the length of the outer surface of the first insulating layer and electrically connected to the circuit trace, A flexible circuit strip comprising: a longitudinal hollow channel formed between any two of the first insulating layer, the second insulating layer, and the third insulating layer, wherein the longitudinal hollow channel is configured to receive an elongated support element; ii. A catheter assembly comprising an expandable basket assembly comprising an expandable end effector comprising an elongated support element disposed within the longitudinal hollow channel, and an expandable end effector.

20. A method for manufacturing a flexible circuit strip, (a) To provide an elongated multilayer laminate, wherein the multilayer laminate comprises an insulating layer containing a flexible polymer, a conductive channel layer clad on the insulating layer and containing a conductive material, an adhesive layer, and another insulating layer containing the flexible polymer. (b) Perforating the multilayer laminate to form an opening that penetrates the other polymer layer and the adhesive layer, thereby exposing the conductive channel layer, (c) A method comprising etching the conductive channel layer to form a longitudinal hollow channel in the elongated multilayer laminate.

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