Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Combined with surgical tool
Reexamination Certificate
1998-08-31
2001-03-06
Snow, Bruce (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Combined with surgical tool
Reexamination Certificate
active
06197053
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices, and more particularly to an apparatus for facilitating the implantation of a stentless bioprosthetic, (e.g., xeno raft, homograft, allograft) heart valve, and associated methodology.
BACKGROUND OF THE INVENTION
Among the various types of prosthetic heart valves which have heretofore been known are certain “stentless” bioprosthetic valves. One example of a stentless bioprosthetic heart valve is described in U.S. Pat. No. 5,197,979 (Quintero, et. al.), the entire disclosure of which is hereby expressly incorporated by reference.
One such stentless bioprosthetic valve is commercially available as the Edwards® PRIMA™ stentless aortic bioprosthesis (Baxter Edwards AG, Spierstrasse 5, GH6048 Horn, Switzerland). This stentless aortic bioprosthesis generally comprises a chemically-tanned porcine aortic heart valve having an adjacent segment of aorta connected thereto. An inflow annulus is defined at the proximal end of the bioprosthesis and an outflow annulus is defined at the distal end thereof. The porcine coronary arteries are cut away from the aortic portion of the bioprosthesis, thereby forming coronary openings in the bioprosthesis. Woven polyester cloth is sewn around the inflow annulus of the bioprosthesis to facilitate suturing of the proximal end of the bioprosthesis to a surgically prepared endogenous aortic valve root of the recipient patient. Thereafter, in cases wherein the entire bioprosthesis is implanted the distal end of the bioprosthesis may be anastomosed to the patient's aorta, and the coronary openings of the bioprosthesis are aligned with, and sutured to, the patient's coronary ostia.
In an alternative implantation procedure, the surgeon may elect to trim or cut away the distal portion of the cylindrical prosthesis body (e.g., that portion above the valve leaflets), and to implant only the proximal portion of the bioprosthesis. In such modified “partial” implantation procedure, it is unnecessary for the surgeon to anastomose that distal end of the distal end of the bioprosthesis and/or the coronary openings to the patient's aorta because such distal portions of the bioprosthesis have been trimmed or cut away prior to its implantation.
The above-described stentless aortic bioprosthesis of U.S. Pat. No. 5,197,979 (Quintero, et al.) was provided with a holding fixture which was attached to the outflow (i.e., distal) end of the bioprosthesis. An elongate handle was connectable to the holding fixture. Such handle was intended to be grasped and manipulated by the surgeon to maneuver the stentless aortic bioprosthesis to its desired implantation position. Certain problems or shortcomings were, however, associated with this holding fixture attached to the outflow (i.e., distal) end of the bioprosthesis. First, the holding fixture was of a configuration which tended to substantially block the outflow end of the prosthetic valve root cylinder, thereby preventing the surgeon from visualizing the valve leaflets from a distal vantage point, during the implantation procedure. Second, because the holding fixture was attached only to the outflow (i.e., distal) end of the stentless bioprosthesis, the exertion of forward pressure against the holding fixture tended to cause the cylindrical body and/or leaflets of the stentless bioprosthesis to compressively deform or buckle, due to the pliable or flexible nature of such stentless bioprosthesis. Such buckling or deformation of the stentless bioprosthesis could be problematic if one were to attempt, in accordance with standard operative technique, to advance the stentless bioprosthesis over a series of pre-placed suture threads which have been passed through the inflow annulus at the inflow (i.e., proximal) end of the bioprosthesis.
In view of the above-described problems associated with the prior art holding fixtures used in conjunction with stentless bioprosthesis, it is desirable to develop an improved holding apparatus which is attachable to the inflow annulus located at the inflow (i.e., proximal) end of the bioprosthesis such that, when proximally directed pressure is exerted against the holding apparatus, such pressure will be transferred through the holding apparatus so as to effect a “pulling” action upon the inflow annulus at the inflow (i.e., proximal) end of the bioprosthesis, rather than a “pushing” action upon the outflow (i.e., distal) end of the bioprosthesis. Furthermore, it is desirable for such improved holding apparatus to be configured and constructed in a manner which does not substantially block the outflow opening at the outflow (i.e., distal) end of the bioprosthesis, thereby allowing the surgeon to clearly view and properly orient the valve leaflets and commissurae of the bioprosthesis during the implantation procedure. Also, it is desirable that the holding apparatus be constructed in a manner which firmly holds the stentless bioprosthesis during any trimming or cutting away of the distal portion of the bioprosthesis, as is sometimes done in the modified or partial implantation technique described hereabove.
SUMMARY OF THE INVENTION
In general, the present invention provides a prosthetic heart valve holding apparatus which comprises a cage or enclosure which substantially surrounds a prosthetic heart valve, and which is releasably attachable to the proximal end of the prosthetic heart valve. A handle may be attachable to the holding apparatus to facilitate advancement of the heart valve to its desired implantation site. Because the cage or enclosure of the holding apparatus is attached to the prosthetic heart valve at or near its proximal end, the exertion of forwardly directed advancement force upon the holding apparatus (e.g., by pushing on a handle attached to the holding apparatus) will be converted into a “pulling” force on the proximal portion of the prosthesis rather than a “pushing” force on the distal end thereof.
In accordance with the invention, the holding apparatus may generally comprise a) a distal hub member and b) a plurality of strut members which extend downwardly from said distal hub member at spaced-apart locations around. The downwardly extending strut members define a prosthetic heart valve receiving space beneath the distal hub member and inboard of the strut members. A bioprosthetic heart valve (e.g., a stentless bioprosthesis) having an annular sewing ring (e.g., a dacron mesh ring) at its proximal end is insertable within the receiving space such that the bottom ends of the strut members may be connected or attached to or immediately above the sewing ring, at the proximal end of the prosthesis. A handle may be formed upon, or may be attachable to, the distal hub member of the holding apparatus such that the handle extends upwardly therefrom. A surgeon may then grasp the handle, and may utilize the handle to advance the holding apparatus (with the heart valve prosthesis releasably mounted therewithin) to the intended implantation site. Because the holding apparatus is connected at or near the proximal (inflow) end of the prosthesis, the exertion of pushing force on the handle will cause a “pulling” force to be applied to the proximal (inflow) end of the prosthesis rather than exerting a “pushing” force against the distal (outflow) end of the prosthesis. In this manner, the holding apparatus allows the bioprosthesis to be advanced into position without compressively deforming or collapsing the prosthesis, and without any need for use of extraneous instruments (e.g., forceps) to grasp and pull the proximal (inflow) end of the bioprosthesis into place. After the proximal (inflow) end of the bioprosthesis has been positioned immediately adjacent the endogenous valve root or other intended site of implantation, sutures may be tied in place to affix the sewing ring at the proximal (inflow) end of the prosthesis to the endogenous valve root or other host tissue. Thereafter, the prosthesis is disconnected and detached from the holding apparatus, and the holding apparatus is extracted and remo
Cosgrove Delos M.
Nguyen Diana
Rhee Richard
Buyan Robert D.
Cumberbatch Guy L.
Edwards Lifesciences Corporation
Snow Bruce
LandOfFree
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