Apparatus and method for delivering an implantable medical device to a diseased cardiac valve

• US 8,715,343 B2
• Filed: 09/08/2010
• Issued: 05/06/2014
• Est. Priority Date: 09/09/2009
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Chen, Ji-Feng, Gao, Shengqiang, Davis, Brian L., Horvath, David J.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US13/394,853
• Publication Number:
  US 20120203332A1
• Time in Patent Office: 1,336 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 623 236- 241, 2271751-1821
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An apparatus is provided for delivering an implantable medical device to a diseased cardiac valve includes an elongated shank, a brace member, and a locking mechanism. The shank has a first end portion, a second end portion, and a first longitudinal axis extending between the end portions. The first end portion includes a rotatable annular lower support and a fixing member. The lower support includes an annular ring having oppositely disposed upper and lower surfaces and a plane extending radially between the upper and lower surfaces. The brace member includes a barrel portion operably connected to a drive system. The barrel portion includes a first end portion, a second end portion, and a second longitudinal axis extending between the end portions. The drive system includes a housing operably connected to an actuating handle. The locking mechanism is operably connected to the housing and the elongated shank.

Claims

1. An apparatus for delivering an annuloplasty ring or prosthetic valve to a diseased cardiac valve having an inferior aspect and a superior aspect, said apparatus comprising:

an elongated shank having a first end portion, a second end portion, and a first longitudinal axis extending between said first and second end portions, said first end portion including a rotatable annular lower support for contacting the inferior aspect of the diseased cardiac valve and a fixing member for securing the annuloplasty ring or prosthetic valve to, or in place of, the diseased cardiac valve, said lower support comprising an annular ring having oppositely disposed upper and lower surfaces and a plane extending radially between said upper and lower surfaces, said lower support and said fixing member being movable relative to one another along said first longitudinal axis;

a brace member comprising a barrel portion operably connected to a drive system, said barrel portion including a first end portion, a second end portion, and a second longitudinal axis extending between said first and second end portions, said drive system comprising a housing operably connected to an actuating handle, said drive system for slidably extending and withdrawing said elongated shank along said second longitudinal axis, said first end portion of said barrel portion includes an annular upper support configured for receiving an annuloplasty ring or prosthetic heart valve; and

a locking mechanism operably connected to said housing and said elongated shank, said locking mechanism for securing said lower support and said fixing member at separate points along said first longitudinal axis of said elongated shank.

2. The apparatus of claim 1, wherein said fixing member has an annular configuration.

3. The apparatus of claim 1 further comprising a vacuum mechanism for stabilizing at least a portion of the tissue surrounding the diseased cardiac valve, said vacuum mechanism being operably coupled to at least one of the upper support and the lower support.

4. The apparatus of claim 1, wherein said second end portion of said elongated shank includes a lower support adjustment mechanism for controlling said lower support.

5. The apparatus of claim 1, wherein each of said upper and lower supports have a saddle-shaped configuration.

6. A method for delivering an annuloplasty ring or prosthetic heart valve to a diseased cardiac valve having an inferior aspect and a superior aspect, said method comprising the steps of:

providing an apparatus comprising an elongated shank, a brace member, and a locking mechanism, the elongated shank having a first end portion, a second end portion, and a first longitudinal axis extending between the first and second end portions, the first end portion including a rotatable annular lower support and a fixing member, the lower support comprising an annular ring having oppositely disposed upper and lower surfaces and a plane extending radially between the upper and lower surfaces, the brace member comprising a barrel portion operably connected to a drive system, the barrel portion including a first end portion, a second end portion, and a second longitudinal axis extending between the first and second end portions, the drive system comprising a housing operably connected to an actuating handle, the locking mechanism being operably connected to the housing and the elongated shank;

providing one of an annuloplasty ring or a prosthetic valve on an annular upper support;

positioning the first end portion of the barrel portion about the superior aspect of the diseased cardiac valve;

extending the lower support through the diseased cardiac valve;

sandwiching at least a portion of the diseased cardiac valve between the upper and lower supports; and

implanting the annuloplasty ring or prosthetic valve on, or in place of, the diseased cardiac valve.

7. The method of claim 6, wherein said step of extending the lower support through the diseased cardiac valve further comprises the steps of:

operating a lower support adjustment mechanism of the elongated shank so that the radial plane of the lower support extends substantially perpendicular to the superior aspect of the diseased cardiac valve;

operating the actuating handle so that the lower support is traversed through the diseased cardiac valve into the ventricle; and

operating the lower support adjustment mechanism so that the radial plane of the lower support extends substantially parallel to the inferior aspect of the diseased cardiac valve.

8. The method of claim 6, wherein said step of sandwiching at least a portion of the diseased cardiac valve between the upper and lower supports further comprises the step of operating the actuating handle to withdraw the elongated shank so that the upper surface of the lower support contacts the inferior aspect of the diseased cardiac valve.

9. The method of claim 6, wherein said step of implanting the annuloplasty ring or prosthetic valve on, or in place of, the diseased cardiac valve further comprises the steps of:

operating the actuating handle so that the fixing member contacts an upper support of the brace member; and

securing the annuloplasty ring or prosthetic valve to, or in place of, the diseased cardiac valve.

10. The method of claim 6, wherein said step of providing an apparatus further comprises providing a vacuum mechanism, the vacuum mechanism being operably connected to at least one of the upper and lower supports.

11. The method of claim 10 further comprising the step of applying a vacuum through at least one of the upper and lower supports to stabilize at least a portion of the heart tissue surrounding the diseased cardiac valve.