Electrophysiological mapping catheter
Disclosed are various examples and embodiments of a cardiac mapping catheter configured for electrophysiological (EP) mapping and suitable for intravascular insertion in a patient's heart, and methods of making same. The cardiac mapping catheter comprises a plurality support arms having electrodes disposed thereon. Various configurations of the cardiac mapping catheter are described and disclosed which provide improved spatial resolution and sensing of EP signals acquired from inside a patient's heart.
1. A cardiac mapping catheter configured for electrophysiological mapping and suitable for intravascular insertion in a patient's heart, comprising:
a flexible elongated body having a distal portion with a distal end and a proximal portion, and
an electrode assembly located at the distal portion, the electrode assembly comprising a plurality x of at least 4 support arms, each support arm having a proximal end part, a distal end part, and a main part located between the proximal end part and the distal end part, each of the plurality of support arms comprising a plurality of electrodes, the electrodes being configured to acquire electrophysiological signals from the patient's heart, the plurality of support arms being configured to have a first retracted condition where the plurality of support arms is arranged in a collapsed bundle, and a second expanded condition where the plurality of support arms forms an expanded basket structure;
wherein the plurality of support arms further comprises first and second neighboring support arms, the proximal end parts of the first and second neighboring support arms being combined or held together to one another, the distal end part of the first support arm being combined or held together to a distal end part of a neighboring support arm that is not the second support arm, the distal end part of the second support arm being combined or held together to a distal end part of a neighboring support arm that is not the first support arm, each of the plurality of support arms in the electrode assembly being combined or held together at its distal end part with a neighboring support arm that is different from the neighboring support arm with which it is combined or held together at its proximal end part, and further wherein each of the plurality of support arms in the electrode assembly is not connect to, or combined or held together with, any of the other of the plurality of support arms along the main parts corresponding thereto.
2. The cardiac mapping electrode of claim 1 , wherein x is evenly divisible by the number 2.
3. The cardiac mapping catheter of claim 1 , wherein at least one of the distal end parts and the proximal end parts are combined or held together with combining means comprising one or more of a polymeric layer, a cover, a sheath, overmolding, tubing, shrink tubing, a clamp, a ring member, an adhesive joint, a lug, a weld, a stake, a crimp, or any combination of the forgoing.
4. The cardiac mapping catheter of claim 3 , wherein the support arms and combining means are together configured such that one support arm cannot be deflected or bent towards a neighboring support arm by an angle exceeding β when at least one of the arms is in contact with a surface, the angle β ranging between about 5° and about 30°.
5. The cardiac mapping catheter of claim 3 , wherein at least some of the combining means comprise an electrically conductive metal or metal alloy forming one or more electrodes, and such electrodes are electrically connected to electrical conductors disposed in one or more of the support arms.
6. The cardiac mapping catheter of claim 1 , wherein at least one of the support arms comprises a flexible electrical polymeric sheet comprising electrodes.
7. The cardiac mapping catheter of claim 1 , wherein the number x of support arms equals 4, 6, 8, 10 or 12.
8. The cardiac mapping catheter of claim 1 , wherein the number of electrodes disposed on each support arm ranges between 4 electrodes and 24 electrodes.
9. The cardiac mapping catheter of claim 1 , wherein the plurality of electrodes disposed on each support arm is distributed spatially evenly thereon.
10. The cardiac mapping catheter of claim 1 , wherein the electrode assembly comprises two pole areas P 1 and P 2 that lie along a basket axis A.
11. The cardiac mapping catheter of claim 10 , wherein in the expanded condition each of the support arms spans a curve of 180° between the two pole areas P 1 and P 2 .
12. The cardiac mapping catheter of claim 10 , wherein an angle α defines a circumferential distance along a support arm from at least one of the poles P 1 and P 2 to a boundary between at least one of the proximal and distal end parts of the support arm and the main part of the support arm, the angle α ranges between 5° and about 40°, and no electrodes are disposed along the circumferential distance or distances defined by the angle α.
13. The cardiac mapping catheter of claim 12 , wherein the angle α ranges between 5° and 30°.
14. The cardiac mapping catheter of claim 12 , wherein the angle α ranges between 10° and 25°.
15. The cardiac mapping catheter of claim 1 , further comprising braided, twisted or stranded electrical conductors operatively connected to the electrodes.
16. The cardiac mapping catheter of claim 1 , wherein at least portions of the flexible elongated body comprise an electrically insulative polymeric material.
17. A method of making a cardiac mapping catheter configured for electrophysiological mapping and suitable for intravascular insertion in a patient's heart, the method comprising:
forming a flexible elongated body having a distal portion with a distal end and a proximal portion, and
forming an electrode assembly configured to be located at or near the distal portion, the electrode assembly comprising a plurality x of at least 4 support arms, each support arm having a proximal end part, a distal end part, and a main part located between the proximal end part and the distal end part, each of the plurality of support arms comprising a plurality of electrodes, the electrodes being configured to acquire electrophysiological signals from the patient's heart, the plurality of support arms being configured to have a first retracted condition where the plurality of support arms is arranged in a collapsed bundle, and a second expanded condition where the plurality of support arms forms an expanded basket structure;
wherein the plurality of support arms further comprises first and second neighboring support arms, the proximal end parts of the first and second neighboring support arms being combined or held together to one another, the distal end part of the first support arm being combined or held together to a distal end part of a neighboring support arm that is not the second support arm, the distal end part of the second support arm being combined or held together to a distal end part of a neighboring support arm that is not the first support arm, each of the plurality of support arms in the electrode assembly being combined or held together at its distal end part with a neighboring support arm that is different from the neighboring support arm with which it is combined or held together at its proximal end part, and further wherein each of the plurality of support arms in the electrode assembly is not connected to, or combined or held together with, and of the other of the plurality of support arms along the main parts corresponding thereto.
18. The method of claim 17 , wherein x is evenly divisible by the number 2.
19. The method of claim 17 , further comprising combining or holding together the distal end parts or proximal end parts with combining means comprising one or more of a polymeric layer, a cover, a sheath, overmolding, tubing, shrink tubing, a clamp, a ring member, an adhesive joint, a lug, a weld, a stake, a crimp, or any combination of the foregoing.