TELESCOPING CATHETER DELIVERY SYSTEM FOR LEFT HEART ENDOCARDIAL DEVICE PLACEMENT

• US 20170216575A1
• Filed: 04/13/2017
• Published: 08/03/2017
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Asleson, Andrea J., Kimmel, Michael W., Marquard, Kyle R., Foerster, Laurie D., Yang, Zhongping
• Granted Patent: US 10,391,305 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.

Claims

1. A method of transseptal delivery of an instrument into a heart, comprising:

employing an elongate first tubular member defining a first lumen extending between a proximal end and a distal end of the first tubular member, the first tubular member having an adjustable portion adjacent its distal end and an elongate second tubular member received within the first tubular member, the second tubular member defining a second lumen extending between a proximal end and a distal end of the second tubular member, the second lumen adapted to receive a puncturing tool and an instrument to be placed in the heart, the second tubular member having a curved portion adjacent its distal end in a relaxed state;

by;

a) advancing the first tubular member such that it extends through a superior entry point into a right atrium of the heart;

b) deflecting the adjustable portion of the first tubular member is toward an atrial septum of the heart;

c) guiding the puncturing tool through the second tubular member and creating a septal puncture;

d) inserting the second tubular member through the septal puncture into a left atrium of the heart;

e) with the first tubular member remaining in the right atrium and with the second tubular member extending through the septal puncture into the left atrium, orienting the curved portion of the second tubular member toward a left ventricle of the heart;

f) with the first tubular member remaining in the right atrium, advancing the second tubular member along the guide into the left ventricle; and

g) with the first tubular member remaining in the right atrium and the second tubular member extending into the left ventricle, advancing the instrument into the left ventricle.

2. The delivery method of claim 1, wherein the second tubular member is rotatable within the first tubular member through an angular range of motion.

3. The delivery method of claim 2, wherein the angular range of motion is at least 360 degrees.

4. The delivery method of claim 1, further comprising inserting dilator within the second tubular member prior to advancement of the second tubular member through the septal puncture.

5. The delivery method of claim 1, wherein the puncturing tool is an RF puncture tool or a mechanical puncture tool.

6. The delivery method of claim 1, wherein the instrument is an electrical lead.

7. The delivery method of claim 1, wherein the first tubular member includes an elongated generally straight portion connected to the adjustable portion, wherein deflecting the adjustable portion comprises causing the curved portion to assume a configuration comprising a first curved segment connected to the generally straight portion, a second curved segment connected to the first curved segment and a third curved segment connected to the second curved segment, each curved segment having a different radius of curvature.

8. The delivery method of claim 7, wherein, in the configuration, the first curved segment has a radius of curvature between about 3 and about 4 times greater than the radii of curvature of the second and the third curved segments.

9. The delivery method of claim 7, wherein, in the configuration, the third curved segment has a subtended angle between about 3 and about 7 times greater than subtended angles of the first and the second curved segments.

10. The delivery method of claim 7, wherein, in the configuration, the first and the second curved segments have subtended angles between about 10 degrees and about 20 degrees and the third curved segment has a subtended angle between about 60 degrees and about 90 degrees.

11. The delivery method of claim 7, wherein'"'"' in the configuration, the first curved segment has a subtended angle of between about 12 degrees and about 13 degrees, the second curved segment has a subtended angle of between about 14 degrees and 16 degrees, and the third curved segment has a subtended angle between about 70 degrees and about 80 degrees.

12. The delivery method of claim 1, wherein the adjustable portion of the first tubular member has a deflection angle of at least about 135 degrees with respect to a line extending from the generally straight portion.

13. The delivery method of claim 1, wherein the adjustable portion of the first tubular member is adjustable through a two-dimensional range of deflection.

14. The delivery method of claim 1, wherein the adjustable portion of the first tubular member is adjustable through a three-dimensional range of deflection.

15. The delivery method of claim 1, wherein the adjustable portion of the first tubular member is curved in a relaxed state.

16. The delivery method of claim 15, wherein the curve of the adjustable portion of the first tubular in the relaxed state portion comprises an out-of-plane configuration.

17. The delivery method of claim 1, wherein in a relaxed state the curved portion of the second tubular member has a first curved segment connected to a generally straight portion of the tubular member, a second curved segment connected to the first curved segment and a third curved segment connected to the second curved segment, each curved segment having a different radius of curvature, wherein the radius of curvature of the first curved segment is between about 7 inches and about 9 inches, the radius of curvature of the second curved segment is between about 2 inches and about 3 inches, and the radius of curvature of the third curved segment is between about 1 inch and about 2 inches.