Annuloplasty sizers for minimally invasive procedures

• US 9,149,207 B2
• Filed: 10/16/2013
• Issued: 10/06/2015
• Est. Priority Date: 03/26/2009
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Sorin Group USA Incorporated (LivaNova Plc), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Sauter, Joseph A., Hargrove, W. Clark III
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US14/055,661
• Publication Number:
  US 20140046219A1
• Time in Patent Office: 720 Days
• Field of Search: 600/587
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• 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 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A sizing plate for sizing a native valve annulus in a patient'"'"'s heart for either valve replacement or repair during a minimally invasive surgical procedure is shown and described. The sizing plate is generally shaped such that it corresponds to the shape of the native valve annulus. Additionally, a thickness of the sizing plate is such that it can be inserted through a space between the ribs of the patient during the procedure. The sizing plate includes two keyways extending though the plate separated by a bridge. The keyways are sized and shaped such that they are adapted to be engaged by a minimally invasive surgical tool such as a laparoscopic grasper. The keyways in conjunction with the bridge facilitate manipulation of the sizing plate by the grasper from an external location.

Claims

1. A method of sizing a native valve annulus of a mitral valve during a minimally invasive mitral valve repair or replacement procedure comprising:

creating a surgical access port in an intercostal space in a patient'"'"'s body;

exposing the native valve annulus;

providing a first sizing plate, the first sizing plate including;

an upper planar surface and a lower planar surface defining a thickness of the first sizing plate;

first and second keyways extending through the first sizing plate from the upper planar surface to the lower planar surface of the first sizing plate;

an aperture extending through the upper and lower planar surfaces disposed near a lower edge of the first sizing plate for accommodating a suture threaded through the aperture; and

a bridge member between the first and second keyways configured to be engaged by a laparoscopic grasping tool;

inserting the suture through the aperture in the first sizing plate and using the suture to lower the first sizing plate into the surgical access port;

engaging the bridge member of the first sizing plate using the laparoscopic grasping tool inserted through the surgical access port;

positioning the first sizing plate in the native valve annulus;

comparing a major dimension and a minor dimension and a shape of the first sizing plate to a major dimension and a minor dimension and a shape of an anterior leaflet of the mitral valve; and

determining the major and minor dimensions and the shape of the anterior leaflet of the mitral valve.

2. The method according to claim 1, further comprising the steps of:

removing the first sizing plate from the patient'"'"'s body;

inserting a second sizing plate through the surgical access port, the second sizing plate comprising a major dimension and a minor dimension and a shape generally corresponding to the shape of the anterior leaflet of the mitral valve;

an upper planar surface and a lower planar surface defining a thickness of the second sizing plate; and

a first keyway and a second keyway to facilitate engagement of a laparoscopic grasping tool with the second sizing plate, the first and second keyways generally centered on the second sizing plate and extending through the second sizing plate from the upper planar surface to the lower planar surface of the second sizing plate;

engaging a bridge of the second sizing plate using the laparoscopic grasping tool inserted through the surgical access port;

positioning the second sizing plate in the valve annulus;

comparing the major and minor dimensions and the shape of the second sizing plate to the major dimension and the minor dimension and the shape of the anterior leaflet of the mitral valve; and

determining the major and the minor dimensions and the shape of the anterior leaflet of the mitral valve.

3. The method according to claim 1, further comprising the step of temporarily suspending the first sizing plate through the surgical access port using the suture.

4. The method according to claim 1, further comprising the step of orienting the first sizing plate on an edge when inserting the first sizing plate through the surgical access port.

5. The method according to claim 2, further comprising the step of orienting the second sizing plate on an edge when inserting the second sizing plate through the surgical access port.

6. The method according to claim 1, wherein the first sizing plate is D-shaped.

7. The method according to claim 2, wherein the second sizing plate is D-shaped.

8. The method according to claim 1, wherein the first sizing plate has a shape corresponding to the shape of the anterior leaflet of the native mitral valve.

9. The method according to claim 2, wherein the second sizing plate has a shape corresponding to the shape of the anterior leaflet of the native mitral valve.

10. The method according to claim 1, wherein the bridge member comprises a bar coupled to the first sizing plate.

11. The method according to claim 1, wherein at least a portion of the first sizing plate is radiopaque.

12. The method according to claim 2, wherein at least a portion of the second sizing plate is radiopaque.