Stabilized coronary sinus catheter handle

Patent metadata

Field	Value
Publication number	US-11857738-B2
Application number	US-202017111621-A
Country	US
Kind code	B2
Filing date	Dec 4, 2020
Priority date	Dec 16, 2019
Publication date	Jan 2, 2024
Grant date	Jan 2, 2024

Abstract

A stabilized coronary sinus catheter system having a proximal section and a distal section with a memory shape portion, and a tip, distal of the memory shape portion. A handle having a body, a tip deflection actuator, a memory shape portion deployment actuator, and an axis. The tip is in line with the axis and the tip deflection actuator is at a first position. The tip is deflected out of alignment with the axis when the tip deflection actuator is at a second position. A third position is a delivery configuration where the memory shape portion and the tip are in line with the axis. The memory shape portion deployment actuator is at a first location. A deployed configuration allows the memory shape portion to form a predetermined shape conforming to the shape of the coronary sinus when the memory shape portion deployment actuator is at a second location.

First claim

What is claimed is:

1. A stabilized coronary sinus catheter system comprising:
a coronary sinus catheter comprising:
a proximal section comprising a proximal stiffness;
a medial section, distal of the proximal section and comprising a medial stiffness; and
a distal section comprising:
a memory shape portion;
a distal tip, distal of the memory shape portion; and
a flexibility greater than the proximal stiffness, the medial stiffness, and a stiffness of the memory shape portion;

a handle, disposed proximal of the proximal section comprising:
a body defining a center axis;
a distal tip deflection actuator configured to be in one of a first, second, or third position along the center axis so that:
(a) in the first position of the actuator, the distal tip is approximately in line with the center axis;
(b) in the second position of the actuator for deflection of the distal tip, the distal tip is out of alignment with the center axis; and
(c) in the third position of the actuator for delivery, the memory shape portion and the distal tip being approximately in line with the center axis; and

a memory shape portion deployment actuator configured to be in one of a first and second locations with respect to the center axis so that the memory shape portion deployment actuator is in the first location during delivery or deflection of the tip and in the second location for deployment of the memory shape portion that forms a predetermined shape approximately conforming to the shape of a coronary sinus of a patient.

2. The stabilized coronary sinus catheter system of claim 1 , further comprising:
a pull wire, comprising:
a first end anchored in the distal tip; and
a second end fixed in the body;

the distal tip deflection actuator attached to the pull wire and configured to displace the pull wire when in the second position.

3. The stabilized coronary sinus catheter system of claim 1 , wherein the actuator deflecting the distal tip causes the distal tip to deflect over a deflection angle between approximately 0° and approximately 180° with respect to the center axis.

4. The stabilized coronary sinus catheter system of claim 1 , further comprising:
a single axis location sensor disposed approximately at the distal tip.

5. The stabilized coronary sinus catheter system of claim 1 , further comprising:
a deflection actuator lock comprising:
an unlocked position permitting the distal tip deflection actuator to move between the first position and the second position; and
a locked position preventing the distal tip deflection actuator to move between the first position and the second position.

6. The stabilized coronary sinus catheter system of claim 1 , further comprising:
a shape memory alloy disposed along the shape memory portion and comprising one end fixed in the body;
a cover tube disposed over a portion of the shape memory alloy and comprising a memory shape portion deployment end fixed to the memory shape portion deployment actuator;
in a delivery configuration the cover tube constrains the shape memory alloy; and
in a deployed configuration the shape memory alloy is unconstrained by the cover tube.

7. The stabilized coronary sinus catheter system of claim 6 ,
the memory shape portion deployment actuator at the first location maintains the cover tube over the shape memory alloy preventing the shape memory alloy from returning to the predetermined shape; and
the memory shape portion deployment actuator at the second location withdraws the cover tube away from the shape memory alloy allowing the shape memory alloy to return to the predetermined shape.

8. The stabilized coronary sinus catheter system of claim 1 , the predetermined shape of the shape memory portion comprises approximately a helical shape.

9. The stabilized coronary sinus catheter system of claim 8 , the predetermined shape of the shape memory portion comprises at least one of:
a proximal section bending radius between approximately 8.5 mm and approximately 9.5 mm;
a distal section bending radius between approximately 7.0 mm and approximately 8.0 mm;
a proximal section helix angle between approximately 110° and approximately 120°;
a distal section helix angle between approximately 150° and approximately 160°;
a shape memory portion length between approximately 42.5 mm and approximately 44.5 mm;
a major diameter of a first helix coil approximately 14.0 mm and approximately 16.0 mm; and
a taper angle between approximately 3.5° and approximately 5.5°.

10. A method of using a coronary sinus catheter to map electrical activity of a heart, the coronary sinus catheter comprising a distal section comprising a memory shape portion, and a distal tip, distal of the memory shape portion; a handle, disposed proximal of a proximal section comprising: a body; a distal tip deflection actuator; a memory shape portion deployment actuator; a cover tube disposed over a portion of the memory shape portion, and a center axis; wherein the distal section comprises a flexibility greater than a proximal stiffness, a medial stiffness, and a stiffness of the memory shape portion; the method comprising the steps of:
delivering, to a coronary sinus of a patient, the coronary sinus catheter in a delivery configuration so that the distal section of the coronary sinus catheter is approximately in line with the center axis;
deflecting the distal tip out of alignment with the center axis to steer the coronary sinus catheter by actuating the distal tip deflection actuator; and
deploying the memory shape portion of the distal section of the coronary sinus catheter in the coronary sinus to prevent movement of the memory shape portion, comprising the steps of:
withdrawing the cover tube from the memory shape portion; and
returning the memory shape portion to a preformed shape.

11. The method of claim 10 , further comprising:
applying a lateral force against the coronary sinus with the memory shape portion deployed.

Assignees

• Biosense Webster Israel Ltd

Inventors

• Highsmith Debby
• Bar-Tal Meir
• Pinnjara Mohammed

Classifications

• A61M25/0136 Primary

  Handles therefor · CPC title

• A61M25/0138

  having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils · CPC title

• A61M25/0147

  with movable mechanical means, e.g. pull wires · CPC title

• A61M2025/0166

  Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided · CPC title

• A61M2205/0266

  Shape memory materials · CPC title