Edwards Lifesciences Corporation

Baxter International Inc.

Lillian J Quintero

Alain F Carpentier

Sophie M Carpentier

Michael N Helmus

Crystal M Cunanan

Christine Loshbaugh

H Chris Sarner

Stefan G Schreck

Diana Nguyen-Thien-Nhon

Victor S Packham

Jong H Wang

Delos M Cosgrove, Iii

A method of treating a biological tissue including crosslinking with glutaraldehyde; immersing the biological tissue in a first solution containing glutaraldehyde and heat in the first solution to a temperature of about 50&#xb0; C. for a first period of time; immersing the biological tissue in a second solution containing a mixture of a crosslinking agent, a denaturing agent and a surfactant; and immersing the biological tissue in a sterilizing solution containing glutaraldehyde and heating the sterilizing solution to a temperature of 37.5&#xb1;2.5&#xb0; C. for a sterilizing period of time. The method may include a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method.

Treating biological tissues to mitigate post-implantation calcification

An apparatus for treating fixed biological tissue to inhibit calcification of the biological tissue following implantation thereof in a mammalian body. The apparatus includes a container for placing the biological tissue in contact with a treatment solution, structure to induce relative tissue/solution movement, and structure to heat the solution. The relative movement may be induced by shaking a container in which the tissue is immersed in the treatment solution, or by stirring the solution within the container. The movement may also be induced by flowing a treatment solution past the tissue to be treated. The tissue may be free to move in the treatment container, or may be restrained from gross movements. The flow may be part of a circulation system having a reservoir, with a heater being provided to heat the treatment solution in the reservoir. Alternatively, a treatment apparatus, including a fluid circulation system if desired, may be enclosed in an incubator. The tissue may be mounted in a planar configuration generally parallel to the direction of fluid flow. A flow column having a plurality of sections divided by perforated baffles may be used to treat multiple tissues at once.

Apparatuses and methods for treating biological tissue to mitigate calcification

A method of treating a biological tissue including contacting the biological tissue with an aqueous sterilizing solution, and maintaining the aqueous sterilizing solution at a temperature of about 50&#xb0; C. for a time period of about 1 to 2 days. The method of treating a biological tissue may be utilized as a terminal sterilization step in a method for fixation of biological tissues, and bioprosthetic devices may be prepared by such fixation method. The fixation method may include the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to the terminal sterilization method. The aqueous sterilizing solution may be glutaraldehyde of about 0.625 weight percent buffered to a pH of about 7.4.

Method for treatment of biological tissues to mitigate post-implantation calcification and thrombosis

A method for fixation of biological tissues, and bioprosthetic devices prepared by such method. The method generally comprises the steps of A) fixing the tissue, B) treating the tissue with a mixture of i) a denaturant, ii) a surfactant and iii) a crosslinking agent, C) fabricating or forming the bioprosthesis (e.g., forming the tissue and attaching any non-biological components thereto) and D) subjecting the bioprosthesis to terminal sterilization.

Method for fixation of biological tissues having mitigated propensity for post-implantation calcification and thrombosis and bioprosthetic devices prepared thereby

Apparatuses for treating biological tissue to mitigate calcification

A system, apparatus and method for tanning of a stentless aortic bioprosthesis, and articles manufactured by such method. The system includes a circulating bath which contains a tanning solution, and a support insert apparatus upon which the bioprosthesis is mounted during the tanning prosthesis. The support insert has i) two (2) coronary Sinus of Valsalva support projections for maintaining the coronary Sinuses of Valsalva in their substantially open, non-collapsed configurations, and ii) one (1) non-coronary Sinus of Valsalva support projection for maintaining the non-coronary Sinus of Valsalva in its substantially open, non-collapsed configuration, during tanning. Additionally, the system may include internal or external support members for maintaining the patency of right and left coronary artery segments, such coronary artery segments being permitted to remain attached to the Aortic bioprosthesis during tanning.

System, apparatus and method for chemical fixation of stentless cardiac

A method for treating fixed biological tissue inhibits calcification of the biological tissue following implantation thereof in a mammalian body. The method includes placing the biological tissue in contact with a treatment solution, inducing relative tissue/solution movement, and heating the solution. The relative movement may be induced by shaking a container in which the tissue is immersed in the treatment solution, or by stirring the solution within the container. The movement may also be induced by flowing a treatment solution past the tissue to be treated. The tissue may be free to move in the treatment container, or may be restrained from gross movements. The flow may be part of a circulation system having a reservoir, with a heater being provided to heat the treatment solution in the reservoir. Alternatively, a treatment apparatus, including a fluid circulation system if desired, may be enclosed in an incubator. The tissue may be mounted in a planar configuration generally parallel to the direction of fluid flow. A flow column having a plurality of sections divided by perforated baffles may be used to treat multiple tissues at once.

Methods and apparatuses for treating biological tissue to mitigate

A stentless aortic heart valve having a disposable holder with a removable handle can be manually reversed by the physician during suturing to provide a relatively unobstructed view into the patient's aorta. A covering applied to strategic regions on the exterior and interior of the device provides a firm ground for suturing the prosthetic heart valve into position, and for attaching the detachable holder.

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Chester, NY, United States of America

Lillian J Quintero