Cardiac mapping catheter
A multi electrode catheter for non contact mapping of the heart having independent articulation and deployment features.
1. A catheter comprising:
an elongate catheter body having a distal end and a proximal end;
a proximal handle segment having an articulation control and a deployment control, said proximal handle segment connected to said proximal end;
an intermediate segment connected to said handle segment;
a deflectable segment connected to said intermediate segment, said deflectable segment adapted to articulate in a plane through an angle in response to said articulation control;
a distal array segment connected to said deflectable segment, said distal array segment including a deployable electrode array that can move from a first retracted position to a second deployed position through a series of known intermediate states, each of the intermediate states having a known shape of the electrode array; and
a deployment mechanism coupled to said deployment control for coupling motion of said deployment control to the deployable electrode array to cause the electrode array to deploy and maintain the deployable electrode array in one of the known intermediate states during generation of an electro-anatomical map, the known shape of the electrode array in each of the intermediate states comprising locations known within 1 mm with the known shape of the electrode array in each of the intermediate states being determined based on a position of the handle segment.
2. The catheter of claim 1 , wherein:
said deployable electrode array is formed from a flexible printed circuit slit to form splines and rolled about the major axis, the splines of the flexible printed circuit including first regions having a first stiffness and second regions that include one or more stiffener layers and have a second stiffness that is greater than the first stiffness, the stiffness of the first and second regions at least partially determining the shape of the electrode array in the deployed position.
3. The catheter of claim 2 wherein:
each spline in said deployable electrode array has a non-uniform shape characteristic resulting in control of the shape of the electrode array in the deployed position.
4. The catheter of claim 2 wherein:
said distal array segment has a uniform and symmetrical distribution of electrodes in the array.
5. The catheter of claim 2 wherein; said
flexible printed circuit comprises: an insulating
a first metal layer supported by a first surface of the insulating layer and a second metal layer supported by a second surface of the insulating layer, the first and second metal layers comprising an electrode material selected from the group consisting of: gold, stainless steel, platinum, platinum-iridium, titanium nitride, platinum black and iridium-oxide;
an overcoat layer supported by the second metal layer configured to insulate the second metal layer;
a first stiffener layer supported by the overcoat layer; and
a second stiffener layer that is separate from the first stiffener layer and disposed on portions of the first stiffener layer to form the second regions that have the second stiffness that is greater than the first stiffness.
6. The catheter of claim 2 further comprising:
a fluid delivery lumen to flood the distal array segment with a fluid injected into the catheter.
7. The catheter of claim 2 further comprising:
a radio-opaque pattern applied to the distal array segment such that the pattern changes during deployment to provide a discernable radiographic image to confirm deployment.
8. The catheter of claim 1 wherein;
said deployable electrode array having bonding apertures at an end of the array adapted for encapsulation.
9. The catheter of claim 1 wherein;
said deployable electrode array having bonding apertures at an end of the array adapted for encapsulation by a thermoplastic material.
10. The catheter of claim 1 wherein:
said electrode array formed from a flexible printed circuit and comprising:
an insulating layer comprising a first side and a second side;
a first metallization layer coated with iridium oxide on the first side of the insulating layer, the first metallization layer configured to increase the surface area of the first metallization layer;
a second metallization layer on the second side of the insulating layer; and
an electrical connection between the first metallization layer and the second metallization layer.
11. The catheter of claim 10 , wherein the first metallization layer comprises a plurality of metal layers.
12. The catheter of claim 10 , wherein the first metallization layer comprises:
a titanium layer supported by the insulating layer;
a gold layer supported by the titanium layer; and
an iridium-oxide layer supported by the gold layer.
13. The catheter of claim 10 , wherein the first metallization layer comprises:
an interface layer supported by the insulating layer;
a conductive layer comprising a copper or gold layer supported by the insulating layer; and
an iridium-oxide layer supported by the conductive layer.
14. The catheter of claim 10 , wherein the first metallization layer comprises:
a conductive layer comprising a copper or gold layer; and
an iridium-oxide layer supported by the conductive layer.
15. The catheter of claim 10 , wherein the second metallization layer comprises a plurality of metal layers.
16. The catheter of claim 10 , wherein the electrical connection between the first metallization layer and the second metallization layer comprises a metallization layer in a via that extends through the first metallization layer, the insulating layer, and the second metallization layer.
17. The catheter of claim 1 , wherein the distal array segment includes a radio-opaque pattern applied to the distal array segment such that the pattern changes during deployment to provide a discernable radiographic image to confirm deployment.
18. The catheter of claim 17 , wherein the radio-opaque pattern comprises one or more of marker bands, coiled wire, and radiopaque ink.
19. The catheter of claim 1 wherein:
said distal array segment has a non-uniform distribution of electrodes in the array with the electrodes being distributed more densely in a distal area of the electrode array.
20. The catheter of claim 1 wherein:
said distal array segment has a non-uniform distribution of electrodes in the array with the electrodes being distributed more densely in regions of the deployed array that are more likely to be positioned closely to the endocardium.
21. The catheter of claim 1 wherein:
said deployable electrode array is formed from a flexible printed circuit slit to form splines and rolled about the major axis, the splines of the flexible printed circuit including first regions having a first stiffness and second regions that include one or more stiffener layers and have a second stiffness that is greater than the first stiffness, the stiffness of the first and second regions at least partially determining the shape of the electrode array in the deployed position, the stiffener layers comprising a material selected from the group consisting of polyimide, a nickel titanium alloy, and PEEK polyether ether ketone.
22. The catheter of claim 1 wherein:
said deployable electrode array is formed from a flexible printed circuit comprising:
an insulating layer;
a first metal layer supported by a first surface of the insulating layer and a second metal layer supported by a second surface of the insulating layer, the first and second metal layers comprising an electrode material selected from the group consisting of: gold, stainless steel, platinum, platinum-iridium, titanium nitride, platinum black and iridium-oxide;
an overcoat layer supported by the second metal layer configured to insulate the second metal layer;
a first stiffener layer supported by the overcoat layer; and
a second stiffener layer that is separate from the first stiffener layer and disposed on portions of the first stiffener layer to form the second regions that have the second stiffness that is greater than the first stiffness.
23. The catheter of claim 1 wherein:
said distal array segment has a uniform and symmetrical distribution of electrodes in the array.
24. The catheter of claim 1 further comprising:
a fluid delivery lumen to flood the distal array segment with a fluid injected into the catheter.
25. The catheter of claim 1 further comprising:
a radio-opaque pattern applied to the distal array segment such that the pattern changes during deployment to provide a discernable radiographic image to confirm deployment.
26. The catheter of claim 21 wherein:
said distal array segment has a non-uniform distribution of electrodes in the array with the electrodes being distributed more densely in regions of the deployed array that are more likely to be positioned closely to the endocardium.