IMAGE-GUIDED HEART VALVE PLACEMENT OR REPAIR

• US 20140221823A1
• Filed: 02/06/2014
• Published: 08/07/2014
• Est. Priority Date: 01/19/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Keogh, James R., Ryan, Timothy R., Eberhardt, Carol E., Stewart, Mark T., Skarda, James R., Laske, Timothy G., Hill, Alexander J., Lemmon, Jack D., Francischelli, David E.
• Granted Patent: US 9,949,831 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/397 electromagnetic other than visible, e.g. microwave
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0044 for the heart
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0096 : Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method for valve replacement or valve repair is disclosed comprising the steps of acquiring an anatomical image of a patient, correlating the image to the patient, guiding a valve replacement delivery member or a valve repair delivery member within the patient while tracking the position of the delivery member in the patient, positioning the valve replacement member or valve repair member in a desired position to place a valve or repair valve and removing the delivery member from the patient. In one aspect, a method and device are provided that involve imaging a native root using an interoperative technique, then introducing a device that is easily visualized in a chosen imaging modality.

Claims

1. A method for determining whether an medical device is appropriate for implanting in a conduit of patient, comprising:

imaging a first section of the conduit of the patient into which the medical device is to be implanted during a first expanded state occurring at a first portion of a heart rhythm;

reimaging the first section of the conduit of the patient during a first contracted state occurring at a second portion of the heart rhythm;

deriving, from the imaging and the reimaging, dimensional characteristics of the first section of the conduit; and

determining whether the medical device is appropriate for implantation in the first section of conduit based on the derived dimensional characteristics.

2. The method of claim 1 wherein the conduit includes the aortic root.

3. The method of claim 1 wherein the medical device is a replacement heart valve.

4. The method of claim 1 comprising allowing blood to flow through the conduit of the patient during the imaging and reimaging.

5. The method of claim 4 wherein the allowing blood to flow comprising reducing blood flow through the conduit of the patient during the imaging and reimaging.

6. The method of claim 1 wherein the determining whether the medical device is appropriate for implantation includes determining whether no medical device is appropriate for implantation.

7. The method of claim 6 comprising imaging the section of the conduit of a patient during a second expanded state and reimaging the section of the conduit of the patient during a second contracted state if no medical device is appropriate for implantation, wherein the second expanded state is different than the first expanded state, and wherein the second contracted state is different from the first contracted state.

8. The method of claim 6 comprising:

selecting a second section of the conduit of the patient into which the medical device is to be implanted,

imaging the second section of the conduit during an expanded state occurring at a first portion of a heart rhythm;

reimaging the second section of the conduit of the patient during a contracted state occurring at a second portion of the heart rhythm

9. A method for determining an appropriate medical device for implanting in a conduit of patient, comprising:

imaging a section of the conduit of the patient into which the medical device is to be implanted during an expanded state occurring at a first portion of a heart rhythm;

reimaging the section of the conduit of the patient during a contracted state occurring at a second portion of the heart rhythm;

deriving, from the imaging and the reimaging, dimensional characteristics of the section of the conduit; and

selecting a medical device for implantation in the section of conduit based on the derived dimensional characteristics.

10. The method of claim 9 wherein selecting the medical device includes verifying the medical device will not block the coronary ostia.

11. The method of claim 9 wherein the deriving includes determining measurements of the conduit of the patient and evaluating parameters of the section of the conduit of the patient.

12. The method of claim 9 wherein the imaging and reimaging are performed with an intraoperative technique.

13. The method of claim 9 wherein the dimensional characteristics include a diameter.

14. The method of claim 9 wherein the dimensional characteristics includes circularity.

15. A method for determining whether an medical device is appropriate for implanting in conduit of a patient, comprising:

inserting a sizing device into a section of the conduit of the patient into which the medical device is to be implanted, wherein the sizing device provides a selected radial force on the conduit of the patient;

imaging the section of the conduit of the patient including the sizing device during an expanded state occurring at a first portion of a heart rhythm;

reimaging the section of the conduit of the patient including the sizing device during a contracted state occurring at a second portion of the heart rhythm;

deriving, from the imaging and the reimaging, dimensional characteristics of the section of the conduit; and

determining whether the medical device is appropriate for implantation in the section of conduit based on the selected radial force and the derived dimensional characteristics.

16. The method of claim 15 wherein the sizing device comprises a balloon.

17. The method of claim 16 wherein the balloon is one of a compliant balloon and a noncompliant balloon.

18. The method of claim 15 wherein the sizing device includes features detectable during imaging and reimaging.

19. The method of claim 15 comprising removing the sizing device prior to implanting the medical device.

20. The method of claim 15 wherein the selected radial force of the sizing device corresponds with a radial force of the medical device to be deployed at the section of conduit of the patient.

21. The method of claim 15 comprising evaluating, from the imaging and reimaging, parameters of the section of the conduit of the patient.

22. The method of claim 21 determining whether the medical device is appropriate for implantation in the section of conduit is further based on the evaluated parameters of the section of the conduit of the patient.

23. The method of claim 15 wherein the dimensional characteristics include a diameter.

24. The method of claim 15 wherein the dimensional characteristics includes circularity.