Universal valve annulus sizing device

• US 9,918,841 B2
• Filed: 02/15/2017
• Issued: 03/20/2018
• Est. Priority Date: 03/19/2009
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Righini, Giovanni, Carlino, Felice Giuseppe, Rolando, Giovanni
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US15/433,970
• Publication Number:
  US 20170156866A1
• Time in Patent Office: 398 Days
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A device for measuring an internal dimension of a native cardiac valve annulus includes an elongated support member having a proximal portion and a distal portion. A measuring portion is coupled to the distal portion, and an indicator is coupled to the proximal portion of the support member. The measuring portion is biased towards a deployed configuration such that when deployed it applies an outwardly directed radial force to the native valve annulus.

Claims

1. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising:

an elongated support member having a proximal portion and a distal portion and a longitudinal axis;

a holder coupled to the distal portion and having an inner bore that extends along the longitudinal axis of the elongated support member;

a hub disposed within the inner bore;

a measuring band having a first end attached to the holder and a second end attached to the hub;

an indicator coupled to the proximal portion; and

a torque applicator coupled to the proximal portion; and

an adjustable knob coupled to the proximal portion,

wherein the measuring band has a contracted configuration in which the measuring band is at least partially wound about the hub to have a contracted diameter equal to or less than a bore diameter of an access instrument, and

wherein a rotational force applied to the torque applicator and the adjustable knob causes deployment of the measuring band, such that the measuring band expands to form a loop with the holder situated inside the loop and the indicator indicates a degree of deployment of the measuring band.

2. The device of claim 1, wherein the measuring band is removable from the distal portion of the elongated support member.

3. The device of claim 1, wherein the torque applicator and the adjustable knob includes a torque limiter configured to restrict the amount of torque transmitted to the measuring band.

4. The device of claim 1, wherein the elongated support member includes a linkage that allows adjustment of the orientation and a shape of a handle of the device, and wherein the elongated support member includes a locking mechanism to lock a position of the elongated support member.

5. The device of claim 1, further comprising a minimally invasive access instrument and wherein the measuring band is configured to be advanced through the minimally invasive access instrument in the contracted configuration.

6. The device of claim 1, wherein the measuring band is configured to generate an outwardly directed radial force against the native cardiac valve annulus and dimensions of the measuring band are selected such that the outwardly directed radial force has a magnitude about equal to that of a self-expanding prosthetic valve to be implanted.

7. The device of claim 1, wherein the measuring band has an expanded configuration in which the measuring band is unwound and has an effective diameter larger than that of the holder.

8. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising:

an elongated support member having a proximal portion and a distal portion and a longitudinal axis;

a holder coupled to the distal portion and having an inner bore that extends along the longitudinal axis of the elongated support member;

a hub disposed within the inner bore;

a measuring band having a first end coupled to the holder and a second end coupled to the hub; and

at least one of a torque applicators and an adjustable knob coupled to the proximal portion,

wherein the measuring band has a contracted configuration in which a portion of the measuring band is wound about the hub and disposed within the inner bore of the holder and the measuring band has a contracted diameter equal to or less than a bore diameter of an access instrument, and

wherein a rotational force applied to the at least one of the torque applicator and the adjustable knob causes deployment of the measuring band, such that the measuring band expands within the annulus to form a loop with the holder situated inside the loop.

9. The device of claim 8, wherein the measuring band is removable from the distal portion of the elongated support member.

10. The device of claim 8, wherein the at least one of the torque applicator and the adjustable knob includes a torque limiter configured to restrict the amount of torque transmitted to the measuring band.

11. The device of claim 8, wherein the elongated support member includes at least one linkage that allows adjustment of an orientation and a shape of a handle of the device, and wherein the elongated support member includes a locking mechanism to lock a position of the elongated support member.

12. The device of claim 8, wherein the adjustable knob includes a locking mechanism to lock the measuring band in a desired configuration.

13. The device of claim 8, further comprising a minimally invasive access instrument and wherein the measuring band is configured to be advanced through the minimally invasive access instrument in the contracted configuration.

14. A device for measuring an internal dimension of a native cardiac valve annulus, the device comprising:

an elongated support member having a proximal portion and a distal portion and a longitudinal axis;

a holder coupled to the distal portion and having an inner bore that extends along the longitudinal axis of the elongated support member;

a hub disposed within the inner bore;

a measuring band having a first end coupled to the holder and a second end coupled to the hub,

an indicator coupled to the proximal portion;

a torque applicator or an adjustable knob coupled to the proximal portion;

wherein the measuring band has a contracted configuration in which the measuring band is at least partially wound about the hub to have a contracted diameter equal to or less than a bore diameter of an access instrument,

wherein a rotational force applied to the torque applicator or adjustable knob causes deployment of the measuring band, such that the measuring band expands to form a loop with the holder situated inside the loop.

15. The device of claim 14, further comprising a minimally invasive access instrument and wherein the measuring band is configured to be advanced through the minimally invasive access instrument in the contracted configuration.