Abstract: 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.

Abstract: Described herein are devices and methods that dampen transient intraocular pressure including pressure spikes experienced by the eye. The illustrative embodiments attenuate pressure waves and, thus, reduce wall stresses in a non-compliant eye such that the optic nerve is protected from damage in an ocular hypertensive or glaucoma patient, or during traumatic ocular procedures, and the refractive disorders of myopia, hyperopia, and/or presbyopia are moderated or reversed. In one embodiment, a compressible attenuation device insertable within the chambers of the eye preferably has an expanded volume within the range of from about 0.01 cc to 7 cc. The attenuation device may include a valve for permitting filling of the attenuation device through a delivery system.

Abstract: 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.

Abstract: A corneal implant injector assembly includes a barrel, a plunger, and an injector tip with a channel having a size and orientation adapted to store and deliver a corneal implant. The corneal implant is preferably stored in the channel in a contracted state. The plunger has an implant engagement tip for engaging and moving the implant within the channel and to deploy the implant. In some embodiments, the injector tip is selectively detachable from the remaining portion of the injector assembly.

Abstract: 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.

Abstract: 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.

Abstract: The implantable lenses described herein provide for modified edge regions. In one example embodiment an implantable lens includes an anterior surface, a posterior surface and an outer edge surface separating the anterior and posterior surfaces. The anterior surface can include a corrective portion and a beveled portion. The beveled portion can be located between the corrective portion and the outer edge surface. The outer edge surface can have a first portion and a second portion, where the first portion abuts the posterior surface and the second portion, and where the second portion further abuts the beveled portion. The modified edge region provides a more gradual transition between the anterior and posterior surfaces.

Abstract: The present invention provides methods of inactivating and removing infectious agents from tissues of use in bioprosthetic devices. The methods include the removal and blockage of binding sites on the tissues for the infectious agents. Also provided are methods for blocking a site on an infectious agent that binds to a site on the tissue.

Abstract: There is a need in the tissue treatment arts of methods for effectively mitigating calcification, reducing calcification and reducing phospholipid content of implanted bioprosthetic tissues. The invention provides an effective protocol for preparing biological tissue for incorporation as a bioprosthetic device. Disclosed herein is the discovery that calcification of biological tissue is mitigated and phospholipid content is reduced by including a step in the pre-implantation protocol whereby the biological tissue is treated with a surfactant and cross linking agent in the absence of a denaturant. Furthermore, the biological tissues prepared under this protocol are well suited for use in bioprosthetic devices.

Abstract: The present invention provides a prosthetic heart valve that includes biologically active agents that retard or prevent the infiltration of fibrous tissue (“pannus”) from the host into the structure of the prosthetic valve. Preventing or decreasing the overgrowth of the prosthetic valve by pannus reduces the complications associated with the implantation and use of prosthetic heart valves.

Abstract: 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.