Two-piece heart valve holder/rotator

• US 4,683,883 A
• Filed: 04/30/1985
• Issued: 08/04/1987
• Est. Priority Date: 04/30/1985
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Hemex Scientific Incorporated
• Inventors: Martin, Richard L.
• Primary Examiner(s): Cline, William R.
• Assistant Examiner(s): Smith, Randolph A.
• Application Number:
  US06/728,836
• Time in Patent Office: 826 Days
• Field of Search: 128/321, 128/345, 128/303 R, 623/2
• US Class Current: 606/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A two-piece heart valve holder engageable by a separate handle for positioning and rotating the heart valve. The holder includes a cylindrically-shaped plug member that has a recessed shoulder at one end and a V-shaped seat at the other end. Two passages extend through the plug member from the one end. A separate grip member includes two legs which extend through the passageways in the plug member. The two legs each include a base member. The two base members are hinged together with the legs biased outwardly, and each leg has an outwardly projecting valve-engaging foot at the distal end thereof. When the upper ends of the legs engage walls defining the passages, the legs are cammed outwardly so that the feet engage the edge of the valve body of the prosthesis to prevent its removal from the plug member. Once the prosthesis is sutured in place, the grip member is released by lifting a tab that extends upwardly from one of the base members.

Claims

1. A heart valve holder for holding a heart valve prosthesis during implantation, comprising, in combination:

a plug means having opposite ends, one of which has a valve-engaging means and having passageway walls defining at least two passageways each extending in a generally axial direction between said opposite ends; and

grip means including two legs extending through said passageways in the plug means, said legs each having a valve-engaging means at the free end thereof and a radially outward-facing surface adjacent a radially inward-facing surface of one of said passageway walls, said valve engaging means of said legs being movable between valve-engaging and valve-releasing positions in response to substantially axially directed movement of said grip means relative to said plug which effects camming engagement between said radially inward-facing surfaces and said radially outward-facing surfaces that cams said free ends radially inward.

2. The combination of claim 1 wherein said grip means further includes a leg-mounting plate having two hinged portions, each portion joined to said other end of a respective leg, said hinged portions being movable between first and second positions corresponding to said valve-engaging and said valve-releasing positions, respectively, and

said plug means having a seating surface oriented at an angle to the axis so as to maintain said hinged portions in said first position.

3. The combination of claim 2 wherein said two portions are hinged together at a common hinge line, and at least one of said portions has plate-engaging means for applying an axial releasing force to at least one of said hinged portions to effect movement of said grip means which moves said leg to said valve-releasing position.

4. The combination of claim 1 wherein said grip means includes a generally flat base member extending radially inwardly from said other end of each of said legs, said base members being interconnected by resilient hinge means biased to maintain said base members in non-coplanar relationship, said base members being oriented at an acute angle to said radially outward-facing surface of the respective leg.

6. The combination of claim 4 wherein the legs are inherently biased outward toward their prosthesis engaging position.

7. The combination of claim 4 in which at least one of the base members of the grip means includes an upwardly extending tab to facilitate retraction of the grip means upon pulling upwardly on the tab.

8. The combination of claim 4 wherein the plug means includes a hole coaxial with the axis of the plug for receiving the handle means, the base members of the grip means having a hole therethrough to provide access to the hole in the plug means.

5. A device for positioning and holding a heart valve prosthesis during implantation comprising, in combination,

substantially cylindrically-shaped plug means having a recessed shoulder at one end sized to fit within the inside surface of the body of the heart valve prosthesis, a seat at the end of the plug means opposite the recessed shoulder, the plug means having two passages therethrough extending between the two ends of the plug means and parallel with the longitudinal axis thereof, wall means projecting upwardly from the periphery of the seat adjacent each passageway, means for receiving a handle for positioning the prosthesis during implantation;

and

grip means including two legs, each sized in length to extend through the passageways in the plug means, each leg depending from a base member, the base members being resiliently hinged together, each leg having an outwardly extending end so that when the legs of the grip are placed through the passageways of the plug, the legs move radially outwardly, the outwardly extending ends engaging the edge of the heart valve prosthesis to secure the same to the plug means and being maintained in such position by a camming force exerted on the grip means by the projecting wall means.

9. The combination of claim 5 wherein the plug means includes two slots on the outside thereof and lying in a plane perpendicular to the axis of the plug means, for receiving locking and stabilizing means in the enclosure for shipping the assembled prosthesis and holder.

10. A device for positioning and holding a heart valve prosthesis during implantation comprising, in combination,

substantially cylindrically-shaped plug means having a recessed shoulder at one end sized to frictionally engage the inside surface of the body of the heart valve prosthesis, a V-shaped seat at the end of the plug means opposite the recessed shoulder, the plug means having two passages therethrough extending between the two ends of the plug means and parallel with the longitudinal axis thereof, wall means projecting upwardly from the periphery of the seat adjacent each passageway, means for receiving a handle for positioning the prosthesis during implantation;

and

grip means including two legs, each sized in length to extend through the passageways in the plug means, each leg depending from a base member, the base members being hinged together, with the outer edge of each leg being angled inwardly from the outer edge of its base member at an angle substantially equal to the angle between each half of the V-shaped seat and a plane perpendicular to the longitudinal axis of the plug means, each leg having an outwardly extending end so that when the legs of the grip are placed through the passageways in the plug, the legs move radially outwardly, and the outwardly extending ends engaging the edge of the heart valve prosthesis to secure the same to the plug means and being maintained in such position by a camming force exerted on the grip means by the projecting wall means.