Reference Devices for Placement in Heart Structures for Visualization During Heart Valve Procedures

• US 20070238979A1
• Filed: 03/22/2007
• Published: 10/11/2007
• Est. Priority Date: 03/23/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Hill, Alex, Douk, Nareak, Rafiee, Nasser, Huynh, Rany
• Application Number:
  US11/689,961
• Publication Number:
  US 20070238979A1
• Time in Patent Office: Days
• US Class Current: 600/420
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2090/063 for measuring volume
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Visualization reference devices to aid in non-direct visualization of heart structure. The devices are positionable in the heat structure and visible with a desired imaging modality. The devices being elastically transformable between delivery configurations and deployment configurations. The devices being used to assist a clinician in mapping the heart structure while implanting therapeutic devices therein. An example would be using the devices disclosed herein to map the size, location, orientation and displacement of a mitral valve annulus for catheter based implantation of a valve repair device.

Claims

1. A system for aiding in the visualization of heart structure during the implantation of a therapeutic device in side of a heart, the system comprising:

at least one visualization reference device configured for placement within the coronary arteries, coronary sinus, aorta, or a heart chamber for treating valvular disease; and

the at least one device is viewable using radiography, fluoroscopy, ultrasonography, trans-echocardiography cardiac magnetic resonance, or magnetic resonance imaging.

2. The system of claim 1 wherein the at least one visualization reference device comprises a plurality of visualization reference devices.

3. The system of claim 1 wherein the at least one visualization reference device comprises an elongated reference wire having a distal end, a proximal end, and a plurality of marker portions;

and the marker portions are viewable using radiography, fluoroscopy, ultrasonography, trans-echocardiography cardiac magnetic resonance, or magnetic resonance imaging.

4. The system of claim 1 wherein the at least one visualization device comprises an expandable element made from a braided material.

5. The system of claim 1 wherein the at least one visualization reference device comprises a biocompatible material chosen from a group consisting of nitinol, stainless steel, age-hardenable nickel-cobalt-chromium-molybdenum alloy, engineering plastic, amides, polyimides, polyolefins, polyesters, urethanes, thermoplastics, thermoset plastics, and blends, laminates or copolymers thereof and combinations thereof.

6. The system of claim 1 wherein at least a portion of the at least one visualization reference device comprises a material viewable by at least one imaging technique selected from a group consisting of radiography, fluoroscopy, ultrasonography, echocardiography, and magnetic resonance imaging.

7. The system of claim 1 wherein at least a portion of the at least one visualization reference device is coated with a material viewable by at least one imaging technique selected from a group consisting of radiography, fluoroscopy, ultrasonography, echocardiography, trans-esophageal echocardiography and magnetic resonance imaging.

8. The system of claim 1 wherein the at least one visualization reference device includes a porous material viewable under ultrasonography.

9. The device of claim 1 wherein the at least one visualization reference device comprises a material chosen from a group consisting of ferromagnetic, paramagnetic and diamagnetic particles, and ultrasmall super-paramagnetic iron oxide, low-molecular-weight gadolinium chelate, gadolinium tetraazacyclododecanetetraacetic acid, and perfluor-octylbromide.

10. A system for aiding in the visualization of heart structure during the implantation of a therapeutic device in side of a heart, the system comprising:

at least one elongated visualization reference wire having a distal end, a proximal end, and a plurality of marker portions evenly spaced along at least a part of the visualization reference wire viewable using radiography, fluoroscopy, ultrasonography, trans-echocardiography cardiac magnetic resonance, or magnetic resonance imaging;

at least one expandable braided visualization reference device viewable using radiography, fluoroscopy, ultrasonography, trans-echocardiography cardiac magnetic resonance, or magnetic resonance imaging; and

at least one catheter for positioning the at least one expandable braided visualization reference device within the structure of a heart.

11. The system of claim 10 wherein the at least one visualization reference wire comprises a plurality of visualization reference wires.

12. The system of claim 10 wherein expandable braided visualization reference device comprises a plurality of expandable braided visualization reference devices.

13. The system of claim 10 wherein the at least one elongated visualization reference wire and the at least one visualization reference device each comprise a biocompatible material chosen from a group consisting of nitinol, stainless steel, age-hardenable nickel-cobalt-chromium-molybdenum alloy, engineering plastic, amides, polyimides, polyolefins, polyesters, urethanes, thermoplastics, thermoset plastics, and blends, laminates or copolymers thereof and combinations thereof.

14. A method for providing visualization references during procedures for heart valve treatment, the method comprising the steps of:

determining heart structure that will be visualized during the procedure;

selecting at least one appropriate visualization reference device for the structure to be visualized;

delivering the at least on visualization reference device to the desired heart structure;

deploying the at least one visualization reference device within the desired heart structure;

viewing the image of the at least one visualization reference device;

delivering and implanting a therapeutic device within the heart; and

removing the at least one visualization reference device from the heart structure.

15. The method of claim 14 wherein the at least one visualization reference device comprises a plurality of visualization reference devices.

16. The method of claim 14 wherein the at least one visualization reference device comprises an elongated reference wire having a distal end, a proximal end, and a plurality of marker portions;

and the marker portions are viewable using radiography, fluoroscopy, ultrasonography, trans-echocardiography cardiac magnetic resonance, or magnetic resonance imaging.

17. The method of claim 14 wherein the at least one visualization device comprises an expandable element made from a braided material.

18. The method of claim 14 wherein the at least one visualization reference device comprises a biocompatible material chosen from a group consisting of nitinol, stainless steel, age-hardenable nickel-cobalt-chromium-molybdenum alloy, engineering plastic, amides, polyimides, polyolefins, polyesters, urethanes, thermoplastics, thermoset plastics, and blends, laminates or copolymers thereof and combinations thereof.

19. The method of claim 14 wherein at least a portion of the at least one visualization reference device comprises a material viewable by at least one imaging technique selected from a group consisting of radiography, fluoroscopy, ultrasonography, echocardiography, and magnetic resonance imaging.

20. The method of claim 14 wherein at least a portion of the at least one visualization reference device is coated with a material viewable by at least one imaging technique selected from a group consisting of radiography, fluoroscopy, ultrasonography, echocardiography, trans-esophageal echocardiography and magnetic resonance imaging.