Tissue sensing device for sutureless valve selection

• US 9,314,163 B2
• Filed: 01/29/2013
• Issued: 04/19/2016
• Est. Priority Date: 01/29/2013
• 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: Venkatasubramanian, Ramji T., Green, Chad Joshua
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/753,099
• Publication Number:
  US 20140213918A1
• Time in Patent Office: 1,176 Days
• Field of Search: 600/508
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A sensing device for a collapsible prosthetic heart valve, the sensing device including an elongated shaft having a proximal end and a distal end, a sensing body coupled to the distal end of the shaft, the sensing body being adapted to fit within a native valve annulus and at least one microelectromechanical sensor attached to the sensing body, the at least one sensing body being capable of measuring a property of tissue.

Claims

1. A sensing device for measuring a property of tissue for selecting a collapsible prosthetic heart valve, the sensing device comprising:

an elongated shaft having a proximal end and a distal end;

a rigid body having an outer surface, the body being coupled to the distal end of the shaft, the body being adapted to fit within a native valve annulus; and

at least one microelectromechanical sensor attached to the body and being disposed on the outer surface of the body, the at least one sensor having a deflectable portion and being capable of measuring a property of tissue adjacent to the native valve annulus by contacting the tissue against the deflectable portion.

2. The device of claim 1, wherein the body is cylindrical.

3. The device of claim 1, wherein the at least one sensor is capable of obtaining data relating to native valve annulus diameter.

4. The device of claim 1, wherein the at least one sensor is capable of obtaining data relating to the elasticity of tissue.

5. The device of claim 1, wherein the at least one sensor comprises at least one capacitor.

6. The device of claim 1, wherein the at least one sensor includes piezoelectric material.

7. The device of claim 1, further comprising a plurality of sensors arranged about the body.

8. The device of claim 7, wherein the plurality of sensors are arranged in a matrix of a plurality of rows and columns which are evenly spaced apart both circumferentially and longitudinally about the body.

9. The device of claim 7, wherein the plurality of sensors are arranged in a matrix of a plurality of rows and columns which are unevenly spaced apart both circumferentially and longitudinally about the body.

10. The device of claim 1, wherein the shaft is radially offset from a central axis of the body.

11. The device of claim 1, wherein the at least one sensor is configured to collect force data by contacting the tissue.

12. A method for measuring a property of tissue for selecting a collapsible prosthetic heart valve, comprising:

introducing a device to the native annulus, the device comprising (i) a rigid body having an outer surface and adapted to fit within a native valve annulus and having a first diameter and (ii) at least one microelectromechanical sensor that is attached to the body and disposed on the outer surface thereof, the at least one microelectromechanical sensor being capable of measuring a property of tissue and having a deformable portion; and

obtaining data related to a property of tissue adjacent the native annulus by contacting the deformable portion of the microelectromechanical sensor with the tissue.

13. The method of claim 12, wherein the data relates to an annulus diameter.

14. The method of claim 12, wherein the obtained data is measurement of a contact force between the tissue and the at least one microelectromechanical sensor.

15. The method of claim 12, wherein the at least one sensor comprises a plurality of sensors arranged about the body, the plurality of sensors being configured to measure elasticity of the tissue.

16. The method of claim 12, further comprising comparing the obtained data to a dataset that includes a relationship between elasticity and blood pressure.

17. The method of claim 12, further comprising comparing the obtained data to a dataset that includes a relationship between valve diameter and blood pressure.

18. The method of claim 12, further comprising removing the device from the native annulus.

19. A system of measuring a property of tissue for selecting a collapsible prosthetic heart valve, the system comprising:

a device having (i) a rigid body having an outer surface and adapted to fit within a native valve annulus, and (ii) at least one microelectromechanical sensor attached to the body and disposed on the outer surface of the body, the at least one sensor having a deformable portion and being capable of measuring a property of tissue adjacent to the native valve annulus by contacting the tissue;

a memory for storing a predefined dataset; and

a processor for using the predefined dataset and information received from the at least one sensor for determining a property of the tissue.

20. The system of claim 19, wherein the predefined dataset includes relationships between blood pressure and desired calcification for a given valve size.

21. The system of claim 19, wherein the predefined dataset includes relationships between blood pressure and desired contact forces for a given valve size.

22. A sensing device for measuring a property of tissue for selecting a collapsible prosthetic heart valve, the sensing device comprising:

an elongated shaft having a proximal end and a distal end;

a body coupled to the distal end of the shaft, the body being adapted to fit within a native valve annulus; and

at least one microelectromechanical sensor having a deflectable portion and being attached to the body, each of the at least one sensor being capable of independently measuring, with respect to others, a property of tissue adjacent to the native valve annulus by contacting the tissue against the deflectable portion.

23. A method for measuring a property of tissue for selecting a collapsible prosthetic heart valve, comprising:

introducing a device to the native annulus, the device comprising (i) a body adapted to fit within a native valve annulus and having a first diameter and (ii) at least one microelectromechanical sensor that is attached to the body, each of the at least one sensor being capable of independently measuring, with respect to others, a property of tissue, and having a deformable portion; and

independently obtaining data related to a property of tissue adjacent the native annulus with each of the at least one microelectromechanical sensor by contacting the deformable portion of the sensor with the tissue.

24. A system of measuring a property of tissue for selecting a collapsible prosthetic heart valve, the system comprising:

a device having (i) a body adapted to fit within a native valve annulus, and (ii) at least one microelectromechanical sensor attached to the body and having a deformable portion, each of the at least one sensor being capable of independently measuring, with respect to others, a property of tissue adjacent to the native valve annulus by contacting the tissue against the deformable portion;

a memory for storing a predefined dataset; and

a processor for using the predefined dataset and information received from the at least one sensor for determining a property of the tissue.