Methods of Steering and Delivery of Intravascular Devices

• US 20180055636A1
• Filed: 07/27/2017
• Published: 03/01/2018
• Est. Priority Date: 08/29/2016
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Randolf von Oepen
• Inventors: Valencia, Francisco, McNiven, Sean A., von Oepen, Randolf
• Granted Patent: US 11,045,315 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A method of delivering a rigid intravascular device to a target location in a patient'"'"'s heart includes positioning a distal tip of an elongated member of the intravascular device delivery system in a right atrium of a heart and moving the distal tip of the elongated member into a left atrium of the heart. The method includes advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance; deflecting at least a portion of the inner steerable catheter a first deflection amount; then advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance; and then deflecting at least a portion of the inner steerable catheter a second deflection amount.

Claims

1. A method of positioning an intravascular device delivery system at a target location, the method comprising:

positioning a distal tip of an elongated member of the intravascular device delivery system in a right atrium of a heart;

moving the distal tip of the elongated member into a left atrium of the heart;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance;

deflecting at least a portion of the inner steerable catheter a first deflection amount;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance; and

deflecting at least a portion of the inner steerable catheter a second deflection amount.

2. The method of claim 1, wherein advancing the inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance and deflecting at least a portion of the inner steerable catheter a first deflection amount occur at least partially simultaneously.

3. The method of claim 1, wherein advancing the inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance and deflecting at least a portion of the inner steerable catheter a second deflection amount occur at least partially simultaneously.

4. The method of claim 1, wherein the first deflection amount is less than 90°

.

5. The method of claim 1, wherein the first longitudinal distance is less than 10 millimeters.

6. The method of claim 1, wherein the second deflection amount is less than 90°

.

7. The method of claim 1, wherein the second longitudinal distance is less than 10 millimeters.

8. The method of claim 1, wherein moving the distal tip of the elongated member in a left atrium of the heart further comprises positioning a distal tip of an outer sleeve of the elongated member in the left atrium within 10 mm of an intra-atrial septum.

9. The method of claim 1, wherein deflecting at least a portion of the inner steerable catheter includes deflecting a rigid intravascular device.

10. The method of claim 1, further comprising deflecting the outer sleeve in a direction opposite to a direction of movement of positioning the distal tip of the elongated member of the intravascular device delivery system in the right atrium of a heart.

11. The method of claim 1, further comprising deflecting the outer sleeve at a location proximal a distal location about which the distal tip of the elongated member of the intravascular device delivery system deflects to position the distal tip in the right atrium of the heart.

12. A method of positioning an intravascular device delivery system at a target location, the method comprising:

positioning a rigid intravascular device in a right atrium of a heart, the rigid intravascular device located at the distal end of an elongated member of the intravascular device delivery system;

moving the rigid intravascular device into a left atrium of the heart;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance;

deflecting at least a portion of the inner steerable catheter a first deflection amount;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance;

deflecting at least a portion of the inner steerable catheter a second deflection amount; and

deploying the rigid intravascular device at the target location.

13. The method of claim 12, wherein advancing the inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance and deflecting at least a portion of the inner steerable catheter a first deflection amount occur at least partially simultaneously.

14. The method of claim 12, wherein advancing the inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance and deflecting at least a portion of the inner steerable catheter a second deflection amount occur at least partially simultaneously.

15. The method of claim 12, wherein a longitudinal length of the rigid intravascular device is greater than 10 millimeters.

16. The method of claim 12, wherein the first deflection amount is less than 45°

.

17. The method of claim 12, wherein the first longitudinal distance is less than 6 millimeters.

18. The method of claim 12, wherein the second deflection amount is less than 45°

.

19. The method of claim 12, wherein the second longitudinal distance is less than 6 millimeters.

20. The method of claim 12, wherein moving the distal tip of the elongated member in a left atrium of the heart further comprises positioning a distal tip of an outer sleeve of the elongated member in the left atrium within 10 mm of an intra-atrial septum.

21. The method of claim 12, wherein deflecting at least a portion of the inner steerable catheter includes deflecting a rigid intravascular device.

22. The method of claim 12, further comprising deflecting the outer sleeve in a direction opposite to a direction of movement of positioning the distal tip of the elongated member of the intravascular device delivery system in the right atrium of a heart.

23. The method of claim 12, further comprising deflecting the outer sleeve at a location proximal a distal location about which the distal tip of the elongated member of the intravascular device delivery system deflects to position the distal tip in the right atrium of the heart.

24. A method of positioning an intravascular device delivery system at a target location, the method comprising:

positioning a rigid intravascular device in a right atrium of a heart, the rigid intravascular device located at the distal end of an elongated member of the intravascular device delivery system and the rigid intravascular device having a longitudinal length at least 10 millimeters;

moving the rigid intravascular device into a left atrium of the heart through an intra-atrial septum;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a first longitudinal distance;

deflecting at least a portion of the inner steerable catheter a first deflection amount;

advancing an inner steerable catheter of the elongated member longitudinally distally relative to an outer sleeve of the elongated member a second longitudinal distance;

deflecting at least a portion of the inner steerable catheter a second deflection amount; and

deploying the rigid intravascular device at the target location.

25. A catheter for delivering a rigid intravascular device to a target location within a human heart through the inferior vena cava, the catheter comprising a steerable catheter having a proximal end, a distal end, an outer wall, a first plurality of cuts formed in a first section of the outer wall in a first cut pattern for causing the steerable catheter to selectively form a first bend in a first direction, and a second plurality of cuts formed in a second section in the outer wall in a second cut pattern for causing the steerable catheter to selectively form a second bend in a second direction.

26. The catheter of claim 25, further comprising:

a plurality of lumens extending through the outer wall of the steerable catheter from its proximal end to its distal end;

a plurality of control lines extending through the lumens, the control lines being fixed at on a distal end to the distal end of the steerable catheter; and

a control fixture having one or more control surfaces connected to a proximal end of the control lines, the control fixture enabling tension to be selectively applied to one or more of the control lines so as to cause the steering catheter to form the first bend in the first direction, to form the second bend in the second direction or to form both the first bend in the first direction and the second bend in the second direction.

27. The catheter of claim 26, wherein the first bend and the second bend both lie within a common plane.

28. The catheter of claim 27, wherein the first cut pattern comprises a one or more slits in a first side of the outer wall.

29. The catheter of claim 28, wherein the first cut pattern further comprises a one or more island cuts in the first side of the outer wall.

30. The catheter of claim 29, wherein the second cut pattern comprises a one or more slits in a second side of the outer wall, the second side being opposite the first side.

31. The catheter of claim 30, wherein the second cut pattern further comprises a one or more island cuts in the second side of the outer wall.