Edwards Lifesciences Corporation

Allergan, Inc.

Medtronic, Inc.

Baxter International Inc.

Advanced Medical Optics, Inc.

Arbor Surgical Technologies, Inc.

Southern Lights Ventures (2002) Limited

Revision Optics, Inc.

Collagen Solutions Nz Limited

Crystal M Cunanan

Michael N Helmus

Glenn R Sussman

Alain F Carpentier

Lillian J Quintero

Craig Young

Christine Loshbaugh

H Chris Sarner

Sophie M Carpentier

Patrice Tremble

Richard S Graham

Dean G Laurin

Richard J Johnson

Neng S Ung-Chhun

Ronald E Cambron

Alexandro Ochoa

Than Nguyen

Hung Ly Lam

Shih-Liang S Yang

Van Le Huynh

Alexandre Carpentier

James E Francese

Thomas M McNicholas

Troy A Miller

Alexander Vatz

Tan Dinh

Saroja Nagaraj Guradzada

Christine May Cabiling

John Joseph Higgins

Saroja Nagaraj Gurazada

Biomaterials with enhanced properties such as improved strength, flexibility, durability and reduced thickness are useful in the fabrication of biomedical devices, particularly those subjected to continuous or non-continuous loads where repeated flexibility and long-term durability are required. These enhanced properties can be attributed to elevated levels of elastin, altered collagen types, and other biochemical changes which contribute to these enhanced properties. Examples of devices which would be improved by use of such tissue include heart valves, including percutaneous heart valves, and vascular grafts, patches and the like. Such enhanced materials can be sourced from specific populations of animals, such as neonatal calves, or in range-fed adult cattle, or can be fabricated or created from cell populations exhibiting such properties. In one embodiment, glutaraldehyde-fixed neonatal pericardial tissue is used to create leaflets in a percutaneous heart valve, and may be used without chemical fixation, with or without processes to remove residual cellular membranes, and utilized as a scaffold material for tissue engineering.

Biomaterials with enhanced properties and devices made therefrom

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

A method for processing biological tissue used in biological prostheses includes providing a tissue procurement solution formed from a phosphate buffered saline (PBS) solution and a chelating agent. The tissue is transferred from the tissue procurement solution and undergoes chemical fixation. The fixed tissue is then immersed in a series of fresh bioburden reduction process (BRP) solutions to extract phospholipids. The tissue procurement solution reduces the bioburden on the stored tissue and preserves tissue architecture by minimizing tissue swelling. The tissue procurement solution further reduces calcium from the incoming water and/or tissue, and inhibits enzymes that digest the collagen matrix. The serial immersion of the tissue in the fresh bioburden solutions ensures optimal extraction of phospholipids thereby mitigating subsequent calcification of the tissue.

Solution for storing bioprosthetic tissue used in a biological prosthesis

Methods for processing biological tissue

Medical devices and methods of producing same are provided. The medical device comprising a body member and a coating on at least a portion of the body member comprising an insitu condensation product of a first electrophilically active, high molecular weight polyalkylene oxide and a second high molecular weight polyoxyalkylene derivative.

Medical devices and products having coatings applied thereto

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

The invention provides methods for treating injuries to one or more internal structures of a subject by administering a drug delivery vehicle to an external surface of the injured structure. The drug delivery vehicle substantially adheres to the site of administration and provides for the release of a bioactive agent that reduces or prevents further injury to the internal structure by disease processes, such as hyperplasia.

Delivery systems for periadventitial delivery for treatment of restenosis and anastomotic intimal hyperplasia

A highly sensitive and specific method for the detection and quantification of lipids is provided. Specifically, methods for the simultaneous detection and quantification of phospholipids extracted from mammalian tissues is described. The analytical methods provided disclose a modified one-dimensional thin-layer chromatography technique specifically developed to rapidly and accurantely detect and quantify phospholipids from mammalian cardiac tissues.

Methods for quantitative and qualitative analyses of phospholipids using one-dimensional thin layer chromatography

An IOL implantable in an eye comprising an optic having an optical portion for directing light toward the retina of the eye and a cell barrier portion for inhibiting cell growth from the eye in front of or in back of the optical portion. The cell barrier portion circumscribes the optical portion, is incapable of focusing light on the retina and includes an irregularly configured structure, for example, irregular grooves. At least one elongated fixation member is coupled to the optic for use in fixing the optic in the eye.

IOL for reducing secondary opacification

Method for producing improved medical devices and devices so produced

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

An expandable annuloplasty ring which may either expand spontaneously, in situ, as the patient grows or be expanded by surgical intervention by balloon dilatation. The distensible annuloplasty ring of the invention may be usable in pediatric patients whose growth, subsequent to surgical implantation of the ring, will necessitate subsequent enlargement of the ring to accommodate growth of the annulus. The ring may include relatively expandable segments to enable the enlargement thereof. The ring segments may include engaging teeth which cooperate with notches or slots formed in the tubes to provide some resistance to ring distention, while preventing collapse of the ring in the opposite direction. The teeth may be of different sizes or shapes to regulate the amount of force needed to expand the ring at different stages of the patient's growth. Alternatively, the adjustable ring includes a solid core of non-elastic material which plastically retains its shape upon natural expansion of the annulus, or after surgical expansion. In one embodiment, segments are coupled together with a discontinuity around the ring periphery. Pivot regions are provided between adjacent segments that, along with the discontinuity, enable the ring to expand upon annulus growth. The discontinuity may be positioned along the anterior side of the ring or around the posterior side. A further version makes use of telescoped segments with no discontinuity. The segments are coupled together with tubular sheaths, and expand without decoupling. A fabric covering may be omitted.

Expandable annuloplasty ring

Growing community of inventors

Mission Viejo, CA, United States of America

Crystal M Cunanan