Image-guided heart valve placement

• US 9,949,831 B2
• Filed: 02/06/2014
• Issued: 04/24/2018
• Est. Priority Date: 01/19/2000
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): Smith, Ruth S
• Application Number:
  US14/174,268
• Publication Number:
  US 20140221823A1
• Time in Patent Office: 1,538 Days
• 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 determining whether a medical device is appropriate for implanting into a cardiovascular conduit of a patient is disclosed 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. The first section of the conduit includes a sizing device providing a selected radial force on the patient.

Claims

1. A method for determining whether a replacement heart valve is appropriate for implanting in a section of a heart of a patient into which the replacement heart valve is to be implanted, the method comprising:

inserting an expandable distal end portion of a sizing device into the section of the heart of the patient into which the replacement heart valve is to be implanted, wherein selective expansion of the distal end portion of the sizing device applies a selected radial force to the section of the heart, wherein the selective expansion of the distal end portion simulates at least one property of the replacement heart valve in a deployed state;

imaging the section of the heart while the distal end portion of the sizing device in an expanded state applies a radial force to the section of the heart during heart rhythm; and

reimaging the section of the heart while the distal end portion of the sizing device in a contracted state does not apply the radial force to the section of the heart during heart rhythm;

deriving, from the imaging and the reimaging, dimensional characteristics of the section of the heart based on images of the distal end portion of the sizing device applying and not applying the radial force to the section of the heart; and

determining whether the replacement heart valve is appropriate for implantation in the section of the heart based on the derived dimensional characteristics of the section of the heart.

2. The method of claim 1 wherein inserting the expandable distal end portion of the sizing device into the section of the heart includes inserting the expandable distal end portion of the sizing device into an aortic root.

3. The method of claim 1 comprising allowing blood to flow through the section of the heart of the patient during the imaging and reimaging.

4. The method of claim 3 wherein the allowing blood to flow comprising reducing blood flow through the section of the heart of the patient during the imaging and reimaging.

5. The method of claim 1 wherein determining whether the replacement heart valve is appropriate for implantation includes determining whether no replacement heart valve is appropriate for implantation.

6. The method of claim 5 wherein the expanded state includes a first expanded state applying a first radial force to the section of the hear during heart rhythm and comprising, if no replacement heart valve is appropriate for implantation, applying a second radial force on the section of the heart with the sizing device by selectively expanding the distal end portion of the sizing device to a second expanded state, imaging the section of the heart including the distal end portion of the sizing device in the second expanded state, and reimaging the section of the heart including the distal end portion of the sizing device in the contracted, wherein the second radial force is different than the first radial force.

7. A method for determining an appropriate replacement heart valve for implanting in a heart of a patient, the method comprising:

inserting an expandable distal end portion of a sizing device into a section of the heart of the patient into which the replacement heart valve is to be implanted, wherein the distal end portion of the sizing device is configured to apply a selected radial force from a variable radial force to the section of the heart;

imaging the section of the heart including the distal end portion of the sizing device in a selected expanded state during heart rhythm, wherein the distal end portion of the sizing device in the selected expanded state simulates at least one property of a replacement heart valve in a deployed state and the selected expanded state applies a selected radial force to the section of heart;

reimaging the section of the heart including the distal end portion of the sizing device in a contracted state during heart rhythm;

deriving, from the imaging and the reimaging, dimensional characteristics of the section of the heart based on images of the distal end portion of the sizing device applying and not applying the selected radial force to the section of the heart; and

selecting a replacement heart valve for implantation in the section of the heart based on the derived dimensional characteristics.

8. The method of claim 7 wherein selecting the replacement heart valve includes determining a stent height of the replacement heart valve to avoid the coronary ostia.

9. The method of claim 7 wherein the deriving includes determining measurements of the section of the heart and evaluating parameters of the section of the heart.

10. The method of claim 7 wherein the imaging and reimaging are performed with an intraoperative technique.

11. The method of claim 7 wherein deriving dimensional characteristics includes deriving a diameter.

12. The method of claim 7 wherein deriving dimensional characteristics includes deriving circularity.

13. A method for determining whether a heart valve prosthesis is appropriate for implanting in a heart of a patient, comprising:

inserting an expandable distal end portion of a sizing device into a section of the heart of the patient, wherein a selected expansion of the distal end portion of the sizing device applies a selected radial force to the section of the heart of the patient;

imaging the section of the heart of the patient including the distal end portion of the sizing device in a selected expanded state during heart rhythm;

reimaging the section of the heart of the patient including the distal end portion of the sizing device in a selected contracted state during heart rhythm;

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

determining whether the heart valve prosthesis is appropriate for implantation in the section of the heart based on the selected radial force and the derived dimensional characteristics.

14. The method of claim 13 wherein inserting the expandable distal end portion of the sizing device comprises inserting a balloon.

15. The method of claim 14 wherein inserting the balloon includes one of inserting a compliant balloon and inserting a noncompliant balloon.

16. The method of claim 13 wherein inserting the sizing device includes inserting a sizing device having features detectable during imaging and reimaging.

17. The method of claim 13 comprising removing the sizing device prior to implanting the heart valve prosthesis.

18. The method of claim 13 wherein providing the selected radial force of the sizing device includes providing a selected radial force corresponding with a radial force of the heart valve prosthesis to be deployed at the section of the heart of the patient.

19. The method of claim 13 comprising evaluating, from the imaging and reimaging, parameters of the section of the heart of the patient.

20. The method of claim 19 determining whether the heart valve prosthesis is appropriate for implantation in the section of the heart is further based on the evaluated parameters of the section of the heart of the patient.

21. The method of claim 13 wherein deriving dimensional characteristics includes deriving a diameter.

22. The method of claim 13 wherein deriving dimensional characteristics includes circularity.