Device, system, and method for aiding valve annuloplasty

• US 20060195134A1
• Filed: 02/28/2005
• Published: 08/31/2006
• Est. Priority Date: 02/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Crittenden, James F.
• Granted Patent: US 7,955,385 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 2090/3954 magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A device comprising a reference ring that may be temporarily disposed in abutment with the inferior perimeter surface of a heart valve to aid non-optical visualization of the valve annulus. The reference ring is elastically transformable between a straight delivery configuration and a generally circular or helical deployment configuration. The reference ring may include an inflatable portion that can be temporarily expanded on the inferior side of the valve annulus to deform the valve annulus into a temporary ledge or shelf for apposition with an annuloplasty ring. A system comprising a delivery catheter including a lumen with an exit port, the reference ring being slidably positionable within the lumen and being extendable from the exit port.

Claims

1. A device for aiding implantation of a heart valve annuloplasty ring, the device comprising an elongate flexible shaft having a reference ring defined along a distal portion thereof, the reference ring being elastically deformable from a pre-formed deployment configuration to a straight delivery configuration, the deployment configuration having at least one coil approximating a size and shape of the annuloplasty ring.

2. The device of claim 1 wherein the reference ring comprises a material viewable by at least one imaging technique selected from a group consisting of radiography, fluoroscopy, ultrasonography, trans-thoracic echocardiography (TTE), trans-esophageal echocardiography (TEE), cardiac magnetic resonance (CMR), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).

3. The device of claim 1 wherein the reference ring includes at least one marker.

4. The device of claim 1 wherein the deployment configuration comprises a helix.

5. The device of claim 1 wherein the reference ring comprises a jacket disposed about a core.

6. The device of claim 5 wherein the core has a tapered distal end.

7. The device of claim 5 wherein the core 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.

8. The device of claim 5 wherein the jacket comprises a porous material viewable under ultrasonography.

9. The device of claim 5 wherein the jacket comprises a material chosen from a group consisting of ferromagnetic, paramagnetic and diamagnetic particles, and ultrasmall super-paramagnetic iron oxide (USPIO), low-molecular-weight gadolinium chelate, gadolinium tetraazacyclododecanetetraacetic acid (Gd-DOTA) and perfluoroctylbromide (PFOB).

10. The device of claim 5 wherein the jacket comprises a balloon and the flexible shaft has an inflation lumen fluidly communicating an interior of the balloon to a fitting located at a proximal end of the device.

11. A system for aiding implantation of a heart valve annuloplasty ring, the system comprising:

an elongate delivery catheter having proximal and distal ends, an exit port adjacent the catheter distal end and a lumen extending from the exit port to the proximal end; and

the elongate shaft of claim 1 being slidably disposed within the catheter lumen, the reference ring being extendable through the catheter exit port and having the straight delivery configuration constrainable by the delivery catheter.

12. The system of claim 11 wherein the exit port is a side port.

13. The system of claim 12 wherein the catheter includes a ramp disposed in the lumen, the ramp being positioned and angled to align the reference ring with the exit port.

14. The system of claim 11 wherein the catheter has a pigtail-shaped tip.

15. A method for aiding implantation of a heart valve annuloplasty ring, the method comprising:

delivering a reference ring in an straight delivery configuration constrained within a delivery catheter to a location near a heart valve;

extending the reference ring through an exit port of the delivery catheter such that the reference ring elastically recovers a preformed deployment configuration;

positioning a portion of the reference ring in inferior abutment with an annulus of the heart valve; and

viewing an image of the positioned reference ring while implanting the annuloplasty ring.

16. The method of claim 15 further comprising:

inflating a balloon on the reference ring subsequent to positioning the reference ring in inferior abutment with the annulus of the heart valve; and

extending the valve annulus around the balloon to form a shelf-like protrusion.

17. The method of claim 15 further comprising:

retracting the reference ring into the delivery catheter.