SYSTEM AND METHOD FOR INTRAPROCEDURAL ASSESSMENT OF GEOMETRY AND COMPLIANCE OF VALVE ANNULUS FOR TRANS-CATHETER VALVE IMPLANTATION

• US 20160296333A1
• Filed: 04/01/2016
• Published: 10/13/2016
• Est. Priority Date: 04/07/2015
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Balachandran, Ram Kumar, Saikrishnan, Neelakantan, Hauck, John, Thao, Riki
• Granted Patent: US 10,716,672 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• 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: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2250/0045 differing in electromagnetical properties

Abstract

A system for determining the dimensions of a native valve annulus may include a sensing catheter, a transmitter, and a computing device. The sensing catheter may include a shaft extending in a longitudinal direction; a plurality of splines attached to the shaft, the splines having an expanded condition spaced radially outward from the shaft; and at least one sensing coil located on each of the splines. The transmitter may generate a magnetic field to induce a potential in each of the sensing coils, and the computing device may identify the positions of the sensing coils based on the induced potentials.

Claims

1. A system for determining the dimensions of a native valve annulus, the system comprising:

a sensing catheter that includes;

a shaft extending in a longitudinal direction;

a plurality of splines attached to the shaft, the splines having an expanded condition spaced radially outward from the shaft; and

at least one sensing coil located on each of the splines;

a transmitter configured to generate a magnetic field to induce a potential in each of the sensing coils; and

a computing device configured to identify positions of the sensing coils based on the induced potentials.

2. The system of claim 1, wherein the sensing catheter includes an expandable balloon positioned between the shaft and the splines.

3. The system of claim 1, wherein the transmitter is an array of drive coils.

4. The system of claim 1, further comprising:

a display configured to output the position of each of the sensing coils.

5. The system of claim 1, wherein the sensing catheter further comprises:

a ring slidably mounted on the shaft, each of the splines having one end attached to the shaft and another end attached to the ring.

6. The system of claim 1, wherein the sensing catheter further comprises:

a spline sheath slidable relative to the shaft between a first position overlying the splines and a second position exposing the splines for movement to the expanded condition.

7. A method for determining the dimensions of a native valve annulus, the method comprising:

delivering a sensing catheter to a native valve annulus, the sensing catheter including a plurality of splines having a contracted condition and a radially expanded condition, each of the splines including a sensing coil;

deploying the plurality of splines from the contracted condition to the radially expanded condition;

generating at least one magnetic field that induces a potential in each of the sensing coils;

determining a first position of each of the sensing coils based on the induced potentials; and

determining a dimension of the native valve annulus based on the first positions of the sensing coils.

8. The method of claim 7, wherein the deploying step includes deploying the plurality of splines so that the sensing coils are at a first plane relative to the native valve annulus.

9. The method of claim 8, further comprising:

moving the plurality of splines from the radially expanded condition to the collapsed condition;

rotating the sensing catheter to change the positions of the sensing coils;

redeploying the plurality of splines from the contracted condition to the radially expanded condition so that the sensing coils are at the first plane relative to the native valve annulus;

generating at least one magnetic field that induces a second potential in each of the sensing coils;

determining a second position of each of the sensing coils based on the second induced potentials; and

determining the dimension of the native valve annulus based on the first and second positions of the sensing coils.

10. The method of claim 8, further comprising:

creating an image of the first plane of the native valve annulus by displaying first data points representing the first positions of the sensing coils and connecting each first data point with an adjacent first data point.

11. The method of claim 10, wherein the creating step includes connecting each first data point with the adjacent first data point using a straight line or fitting a smooth curve to connect all of the first data points.

12. The method of claim 11, further comprising:

moving the plurality of splines from the radially expanded condition to the collapsed condition;

translating the sensing catheter so that the sensing coils are at a second plane different from the first plane relative to the native valve annulus;

redeploying the plurality of splines from the contracted condition to the radially expanded condition so that the sensing coils are at the second plane relative to the native valve annulus;

generating at least one magnetic field that induces a second potential in each of the sensing coils;

determining a second position of each of the sensing coils based on the second induced potentials; and

determining a second dimension of the native valve annulus based on the second positions of the sensing coils.

13. The method of claim 12, further comprising:

creating an image of the second plane of the native valve annulus by displaying second data points representing the second positions of the sensing coils and connecting each second data point with an adjacent second data point.

14. The method of claim 13, further comprising:

constructing a three-dimensional model of the native valve annulus based on the image of the first plane of the native valve annulus and the image of the second plane of the native valve annulus.

15. The method of claim 7, wherein the sensing catheter includes a shaft and a balloon positioned between the splines and the shaft, and the deploying step includes:

inflating the balloon to a first inflated condition between the deploying step and the generating step.

16. The method of claim 15, further comprising:

after the determining step, inflating the balloon to a second inflated condition.

17. The method of claim 16, further comprising after the step of inflating the balloon to the second inflated condition:

generating at least one magnetic field that induces a second potential in each of the sensing coils;

determining a second position of each of the sensing coils based on the second induced potentials;

determining a displacement of each of the sensing coils based on the first and second positions; and

determining a degree of compliance of the native valve annulus based on the displacement of each of the sensing coils.

18. The method of claim 17, wherein the displacement of each of the sensing coils is the difference between the second position of the sensing coil and the first position of the sensing coil.

19. The method of claim 17, further comprising:

determining a degree of calcification of the native valve annulus based on the degree of compliance.

20. An apparatus, comprising:

a shaft extending in a longitudinal direction;

a plurality of splines attached to the shaft, the splines having an expanded condition spaced radially outward from the shaft;

at least one sensing coil located on each of the splines; and

an expandable balloon positioned between the shaft and the splines.