|Publication number||USRE42395 E1|
|Application number||US 11/907,535|
|Publication date||May 24, 2011|
|Filing date||Oct 12, 2007|
|Priority date||Oct 29, 1981|
|Also published as||CA1188590A, CA1188590A1, US7018407|
|Publication number||11907535, 907535, US RE42395 E1, US RE42395E1, US-E1-RE42395, USRE42395 E1, USRE42395E1|
|Inventors||John Thomas Matthew Wright, George Moreno Acosta, Jeffrey James Giba|
|Original Assignee||Medtronic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (18), Non-Patent Citations (21), Referenced by (12), Classifications (4), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
1. Field of the Invention
This invention relates to prosthetic heart valves and more particularly to a device for holding and positioning the heart valve during surgical implantation.
2. Description of Prior Art
Natural heart valves taken from animals, particularly porcine heart valves, have been widely used for several years in the replacement of diseased valves in humans. The porcine valve suitably treated with gluteraldehyde or other fixative solution is mounted on a cloth covered stent or supporting framework prior to implantation. The stent is typically an open cylindrical device having a gently scalloped base curve and three axially extending commissure support struts adapted to support the margins of the valve cusps as illustrated in U.S. Pat. No. 3,570,014. The stent is constructed of metal or plastic, covered with a cloth material, and provided with a circumferential sewing cushion extending outward from the base.
To facilitate handling of the valve during implantation, valve manufacturers have provided various valve holding devices which attach to the valve and allow the surgeon to more easily place the mounting sutures and position the valve in the original valve annulus. Once the valve and sutures are in position, the valve holder is detached from the valve and the surgical implantation procedure is completed.
Valve holders of the prior art consist in general of a support member sutured to the sewing cushion of the valve and an elongated handle which attaches to the support member by screw threads or other suitable means. The valve holder is separated from the valve by cutting the attaching sutures and withdrawing the handle and support member from the operating area. The handle may optionally include an elbow or other means to permit the valve to be angled relative to the main axis of the handle.
In mitral and tricuspid valve replacement, the prosthetic valve is inserted into position with the cusps directed away from the surgeon. In this position the cusps of the valve are subject to damage from snagging in the surrounding anatomical profile as the valve is moved into position and difficulty is sometimes encountered in inserting the valve into the original valve annulus. The mounting sutures are also suseptible to looping over the commissure posts as the valve is moved into position. Even with the aid of a valve holder, placing the valve in position is a sensitive and delicate procedure.
It is accordingly an object of the present invention to provide a valve holder for natural tissue prosthetic heart valves. It is a further object of this invention to provide a holder for mitral and tricuspid valves which facilitates the positioning of the valve within the original valve annulus. It is a yet further object of the present invention to provide a valve holder which permits the commissure support struts of the valve stent to be drawn toward one another prior to placement of the valve, thereby reducing the diameter of the leading portion of the valve and the possibility of snagging the valve cusps and damaging the delicate valve tissue. These and other objects of the invention will be apparent from the ensuing description and claims.
The valve holder of the present invention consists of a central support member having three spaced valve support legs extending radially therefrom. A foot at the distal end of each leg is provided with thread guiding and attaching means. The central support member is provided with thread collecting means.
The valve holder is positioned on the sewing cushion of the valve stent with the legs of the holder in registry with the commissure support struts. The foot of each support leg is secured to the sewing cushion by means of retention threads which are placed through the valve holder and valve stent as follows.
The free end of one thread which is preferably a size 4-0 braided polyester suture is secured to the thread collection means of the central support member and passed through the guide means in the foot of one valve support leg and on through the underlying sewing cushion of the stent. The thread proceeds through the fabric cover at the tip of the proximate commissure support strut, across the valve orifice area to the tip of an adjacent commissure support strut, through the fabric cover at the tip of said strut and thence through the sewing cushion and overlying foot of the corresponding adjacent valve support leg. The end of the suture is thereupon attached to the foot of that support leg. The procedure is repeated with two additional sutures which are attached respectively to the remaining two suture legs.
When all of the sutures have been placed as described above, the valve holder may be drawn tightly against the sewing cushion of the stent by activating the thread collecting means to take up any slack in the sutures. Further activation of the thread collecting means will result in increased tension on the sutures with the tips of the commissure support struts being drawn inward to impart a tapered configuration to the valve. This taper permits the valve to be guided-into the original valve annulus more easily and with minimum danger of snagging or damaging the delicate valve cusp tissue. The retention threads extending across the valve orifice area between commissure support struts also reduce the possibility of the mounting sutures looping over the struts.
Once the valve is positioned in the annulus of the patient and the surgeon is ready to remove the valve holder, each retention thread is cut at the point between the foot of the valve support leg and the central support area. As the threads are cut, the commissure support struts are released from the restraints imposed by the threads and return to their normal configuration. The valve holder and handle are then separated from the valve with the loose ends of each thread remaining attached to the valve holder and being withdrawn from the valve as the holder is removed.
Referring now to
Valve holder 10 consists of a central support member 15 and three valve support legs 16 (two visible in
With further reference to
Thread guide and attaching means 25 in the foot of each valve support leg is more clearly illustrated in
The inner wall of central support cylinder 15 preferably includes a ratchet surface as illustrated in
Referring now to
Also illustrated in
The assembled valve holder is illustrated in cross section in
The thread guide and attaching means in the foot of each valve support leg may be a simple drill hole as illustrated in
The retention thread configuration as described and illustrated above results in the tips of the stent commissure support struts being drawn together as the thread collection device is rotated to wind one end of each thread around stub axle 28. By thus reducing the spread of the commissure support struts, placement of the valve in a confined area is facilitated and the possibility of damaging the delicate tissue of the valve mounted within the confutes of the stent is reduced. To release the valve after it is positioned within the valve annulus, each thread is cut at a convenient spot over the valve support leg. As the thread tension is released the commissure support struts return to their normal spread. The threads passing through the valve stent remain securely attached to the valve support legs and the cut ends are withdrawn from the stent as the holder is removed from the area.
The preceding description and drawings are to a specific preferred embodiment of the present invention and are not for purposes of limitation. The key element of the present invention resides in the combination of the valve holder and the attaching threads which permit the threads to be collected by the valve holder in order to draw the tips of the commissure support struts toward each other and provide a tapered valve configuration.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3099016 *||Aug 11, 1960||Jul 30, 1963||Edwards Miles Lowell||Heart valve|
|US3263239 *||Apr 1, 1963||Aug 2, 1966||Edwards Lab Inc||Aorta valve with expansible suturing ring|
|US3365728 *||Dec 18, 1964||Jan 30, 1968||Edwards Lab Inc||Upholstered heart valve having a sealing ring adapted for dispensing medicaments|
|US3409013||Oct 23, 1965||Nov 5, 1968||Berry Henry||Instrument for inserting artificial heart valves|
|US3466671 *||Oct 19, 1966||Sep 16, 1969||Edwards Lab Inc||Heart valve prosthesis having a cloth covered body|
|US3509582 *||Jul 3, 1967||May 5, 1970||American Hospital Supply Corp||Heart valve with plastic covered cage legs|
|US3534410 *||Oct 7, 1968||Oct 20, 1970||Edwards Lab Inc||Cloth covered heart valve with composite materials in the areas of ball contact|
|US3570014 *||Sep 16, 1968||Mar 16, 1971||Warren D Hancock||Stent for heart valve|
|US3628535||Nov 12, 1969||Dec 21, 1971||Nibot Corp||Surgical instrument for implanting a prosthetic heart valve or the like|
|US3656185 *||Feb 4, 1970||Apr 18, 1972||Rhone Poulenc Sa||Cardiac valvular support prosthesis|
|US3710744 *||Feb 24, 1971||Jan 16, 1973||Cutter Lab||Method and device for manufacture of heart valve|
|US3723996 *||Dec 7, 1971||Apr 3, 1973||American Hospital Supply Corp||Cloth covered heart valve with protected cage legs|
|US3755823 *||Apr 23, 1971||Sep 4, 1973||Hancock Laboratories Inc||Flexible stent for heart valve|
|US3755829 *||Mar 28, 1972||Sep 4, 1973||A Mc Neil Corps||Turbulence suppression apparatus for a body of water|
|US4106129 *||Aug 26, 1977||Aug 15, 1978||American Hospital Supply Corporation||Supported bioprosthetic heart valve with compliant orifice ring|
|US4185636 *||Dec 29, 1977||Jan 29, 1980||Albert Einstein College Of Medicine Of Yeshiva University||Suture organizer, prosthetic device holder, and related surgical procedures|
|US4865600 *||Aug 25, 1981||Sep 12, 1989||Baxter International Inc.||Mitral valve holder|
|GB2011259A *||Title not available|
|1||A Suture Holder and Separator Attachment To The Srarr-Edwards Prosthetic Valve Holders, J.T. Grisner, M.D., and G.W. LilleiHei, M.D. Surgery, Gynecology and Obstetrics, pp. 583-584 (Mar. 1965).|
|2||*||A Suture Holder and Separator Attachment To The Starr-Edwards Prosthetic Valve Holders, J.T. Grismer, M.D., and G.W. Lillehei, M.D., F.A.C.S., Surgery, Gynecology and Obstetrics, pp. 583-584 (Mar. 1965).|
|3||Annals of Thoracic Surgery, A Method for Insertin of a Stented Xenograft Valce in the Atrioventicular Position, George Stefanik, M.D., et al., pp. 166-167 (Jan.-Jun. 1976).|
|4||Annals of Thoracic Surgery, Delayed Rupture of the Left Ventricle after Mitral Valve Replacement with Bioprosthesis, L. Nunez, M.D., et al., vol. 27, No. 5 (May 1979) pp. 465-466.|
|5||Annals of Thoracic Surgery, Entanglement of Sutures with Struts of Mitral Bioprothesis: How to Prevent, N. Spampinato, M.D. et al., 1980 by the Society of Thoracic Surgeons, pp. 478-479, (Jan.-Jun. 1981).|
|6||Annals of Thoracic Surgery, Posterior Midventricular Rupture after Mitral Valve Replacemenr, Gordon Katske, M.D., et al., vol. 27, No. 2, pp. 230-232 (Feb. 1979).|
|7||Annals of Thoracic Surgery, Prevention of "Strut-Snagging" during Mitral Valve Replacement with Stented Tissue Valves, Joseph B. Borman, M.B.B.Ch. (Wits.) et al., vol. 32, No. 2, pp. 209-210, (Aug. 1981).|
|8||Annals of Thoracic Surgery, Safer Insertion of Ionescu-Shiley Valves in the Atrioventricular Position, Graham N. Morritt, F.R.C.S. et al., pp. 94-95 (Jan.-Jun. 1982).|
|9||*||Carpentier-Edwards Bioprosthesis, Glutaraldehyde-Preserved Flexible Support-Mounted Porcine Valves, American Edwards Laboratories, pp. 1118-1129 (Aug. 1980, Prev. Rev. Jan. 1979).|
|10||Carpentier-Edwards® Bioprostheses, Glutaraldehyde-Preserved Flexible Support-Mounted Porcine Valves, American Edwards Laboratories, pp. 1118-1129, (Aug. 1980, Prev. Rev. Jan. 1979).|
|11||*||Instructions for Use of the Handle/Holder Assembly, For the Carpentier-Edwards Aortic Bioprosthesis, Edwards Laboratories, pp. 1-2 (Feb. 1980, Prev. Rev. Dec. 1979).|
|12||*||Package Insert #106259-2 Rev. B, American Edwards Laboratories, "Instructions For Use of the Handle/Holder Assembly For the Carpentier-Edwards Mitral Bioprosthesis", four pages.|
|13||Package Insert #106259-2 Rev. B, American Edwards Laboratories, Instructions For Use of the Handle/Holder Assembly For the Carpentier-Edwards® Mitral Bioprosthesis.|
|14||*||Starr-Edwards and Carpentier-Edwards, Ancillary Equipment for Cardiac Prostheses, Edwards Laboratories, pp. 1-4 (Oct. 1976, Prev. Rev. Sep. 1976).|
|15||*||The Annals of Thoracic Surgery, A Method for Insertion of a Stented Xenograft Valve in the Atrioventricular Position, George Stefanik, M.D., et al., pp. 166-167 (Jan.-Jun. 1976).|
|16||*||The Annals of Thoracic Surgery, Delayed Rupture of the Left Ventricle after Mitral Valve Replacement with Bioprosthesis, L. Nunez, M.D., et al., vol. 27, No. 5, pp. 465-466 (May 1979).|
|17||*||The Annals of Thoracic Surgery, Entanglement of Sutures with Struts of Mitral Bioprosthesis: How to Prevent It, N. Spampinato, M.D., et al., 1980, by the Society of Thoracic Surgeons, pp. 478-479 (Jan-Jun. 1981).|
|18||*||The Annals of Thoracic Surgery, Posterior Midventricular Rupture after Mitral Valve Replacement, Gordon Katske, M.D., et al., vol. 27, No. 2, pp. 230-232 (Feb. 1979).|
|19||*||The Annals of Thoracic Surgery, Prevention of "Strut-Snagging" during Mitral Valve Replacement with Stented Tissue Valves, Joseph B. Borman, M.B. B.Ch. (Wits.), F.R.C.S., et al., vol. 32, No. 2, pp. 209-210 (Aug. 1981).|
|20||*||The Annals of Thoracic Surgery, Safer Insertion of Ionescu-Shiley Valves in the Atrioventricular Position, Graham N. Morritt, F.R.C.S. et al., pp. 94-95 (Jan.-Jun. 1982).|
|21||*||The Annals of Thoracic Surgery, Stented Xenograft Valve Insertion, Edward Proctor, M.D., et al., vol. 29, No. 4, Apr. 1980, 2 pages.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8790398||Dec 20, 2013||Jul 29, 2014||Colibri Heart Valve Llc||Percutaneously implantable replacement heart valve device and method of making same|
|US8900294||Apr 15, 2014||Dec 2, 2014||Colibri Heart Valve Llc||Method of controlled release of a percutaneous replacement heart valve|
|US8968394||May 11, 2012||Mar 3, 2015||Edwards Lifesciences Corporation||Mitral heart valve holder and storage system|
|US9078750||Nov 29, 2011||Jul 14, 2015||Edwards Lifesciences Corporation||Ergonomic mitral heart valve holders|
|US9119738||Jun 28, 2011||Sep 1, 2015||Colibri Heart Valve Llc||Method and apparatus for the endoluminal delivery of intravascular devices|
|US9125739||Apr 15, 2014||Sep 8, 2015||Colibri Heart Valve Llc||Percutaneous replacement heart valve and a delivery and implantation system|
|US9186248||Feb 6, 2012||Nov 17, 2015||Colibri Heart Valve Llc||Percutaneously implantable replacement heart valve device and method of making same|
|US9259316||Apr 10, 2015||Feb 16, 2016||St. Jude Medical, Cardiology Division, Inc.||Aortic valve holder with stent protection and/or ability to decrease valve profile|
|US9554898||Sep 30, 2014||Jan 31, 2017||Colibri Heart Valve Llc||Percutaneous prosthetic heart valve|
|US9610158||Nov 13, 2012||Apr 4, 2017||Colibri Heart Valve Llc||Percutaneously implantable replacement heart valve device and method of making same|
|US9636220||Jan 6, 2016||May 2, 2017||St. Jude Medical, Cardiology Division, Inc.||Aortic valve holder with stent protection and/or ability to decrease valve profile|
|WO2013165937A1||Apr 30, 2013||Nov 7, 2013||St. Jude Medical, Cardiology Division, Inc.||Aortic valve holder with stent protection and/or ability to decrease valve profile|