Abstract: A parallel plate structure (1) is provided with a pair of bimorph piezoelectric elements (2) and prismatic insulation spacers (3) inserted between the piezoelectric elements (2) at the upper and lower ends thereof for cementing the piezoelectric elements (2) together via the spacers (3). Each piezoelectric element (2) comprises a planar base material (4) of titanium, PZT thin films (5) formed on both sides of the base material (4) by the hydrothermal method, and electrode films (6) formed on the PZT thin films (5). The base material (4) is 20 &mgr;m thick and the PZT thin films (5) are several pm thick, while the aluminum electrode films (6) are several um thick.

Abstract: A delivery catheter for a radially expandable intraluminal stent or stented graft. The delivery catheter comprises an elongate catheter body defining proximal and distal ends and at least one lumen extending longitudinally therethrough. Disposed on the catheter body at a location proximal to the distal end thereof is an inflatable, expandable balloon. The balloon is at least partially fabricated from a conformable material for allowing the stent to be at least partially embedded therein when positioned thereupon.

Abstract: A frame element assembly suitable for forming the frame of a display holder, the frame element assembly having a base portion and a retaining leaf, the retaining leaf being pivotally mounted with respect to the base portion, the retaining leaf being held in a pivotal arrangement by a bow spring, the assembly being adapted such that in use the retaining leaf can pivot between an “open” position in which display material can be inserted or removed from the display holder and a “closed” position in which display material is retained within the display holder. The assembly is adapted such that the retaining leaf is removably mounted with respect to the pivot arrangement when the display holder is in its assembled state.

Abstract: Method and apparatus for utilizing the vascular system as a conduit to reach other vascular and extravascular locations within the body. Included are methods for revascularization wherein the extravascular passageways are formed to permit blood flow between vascular locations. Also included are methods for performing transvascular interstitial surgery (TVIS) wherein extravascular passageways are formed from a blood vessel to another vascular or non-vascular intracorporeal location. Also disclosed are devices usable for forming extravascular passageways in accordance with the invention, or for modifying, valving, maintaining or closing such passageways.

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 method for inserting and maintaining an intracranial pressure monitoring catheter within a skull of a patient using a flexible catheter having a stylet insertion aperture formed in the side wall thereof opening to a stylet lumen extending to a closed distal end of the catheter. Two incisions are made in the scalp at a spaced distance apart. A bore hole through the patient's skull is then formed beneath a first of the incisions, and the catheter is inserted underneath the scalp from the second incision and out of the first incision until the stylet insertion aperture is exposed. A stylet is then inserted into the stylet insertion aperture and into the stylet lumen to impart stiffness to a distal portion of the catheter. The stylet-containing portion of the catheter is then inserted through the bore hole and advanced such that a pressure sensing/transmitting component on the distal end of the catheter is located intracranially.

Abstract: In general, the present invention comprises an holding apparatus for facilitating implantation of a prosthetic heart valve within a mammalian heart. The holding apparatus generally comprises a cage or enclosure having a heart valve prosthesis retention space defined therewith. The proximal end of the holding apparatus is releasably attached to the proximal end of the heart valve prosthesis such that, when the holding apparatus is advanced in a forward direction, a “pulling” force will be exerted upon the proximal end of the prosthesis, rather than a “pushing” force being exerted upon the distal end of the prosthesis.

Abstract: Methods, devices, and systems for a) revascularization and/or b) performing other medical procedures at vascular or non-vascular intracorporeal locations within a mammalian body. The methods generally comprise the formation of at least one extravascular passageway from a blood vessel to a vascular or non-vascular target location. In the revascularization methods the extravascular passageway is utilized for blood flow. In the medical procedure methods the extravascular passageway is utilized as a conduit for accessing or performing procedures at the vascular or non-vascular target location. Also disclosed are catheter devices and systems which are useable to form the extravascular passageways of the invention, as well as apparatus for modifying, maintaining and/or closing such extravascular passageways.

Abstract: An extracorporeal blood processing method and system wherein blood is extracted from a mammalian subject through a blood withdrawal tube having a blood pump, such as a peristaltic pump, positioned thereon. A "distal segment" of the blood withdrawal tube extends from the mammalian subject to the inlet side or withdrawal pump. A "proximal segment" of the blood withdrawal tube extends from the outlet side of the blood pump to an extracorporeal blood processing apparatus. An anticoagulant feed tube is connected to the "proximal segment" of the blood withdrawal tube such that a flow of anticoagulant solution may be combined with blood exiting the outlet of said blood pump and passing through the "proximal segment" of said blood withdrawal tubing.

Abstract: 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.

Abstract: A method for preparing collagenous biological tissues for use as implantable bioprosthetic material, and articles prepared thereby. The method generally comprises the steps of a) contacting the tissue with an aldehyde fixative to effect cross-linking of the connective tissue protein(s) and subsequently b) contacting the tissue with a polyglycidyl ether. The treatment of the crosslinked tissue with the polyglycidyl ether serves to mitigate the tissue's propensity to undergo calcification following implantation in the body.

Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a "button" or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Abstract: Methods and apparatus for qualitatively or quantitatively determining one or more analytes in matrices such as foods, biological fluids, etc. An embodiment for determination of a single analyte comprises a sample receiving vessel, a first membrane and a reagent-containing well. The prepared sample passes through the first membrane whereby extraneous matter is removed, and a filtrate enters the reagent-containing well to provide a filtrate-reagent admixture from which the analyte may be determined. An embodiment for determination for multiple analytes includes one or more additional membranes in series with the first membrane, each such additional membrane being operative to capture one or more analytes. Each of the additional analytes may then be eluted from the membrane upon which it has been captured, into a separate reagent-containing well to provide eluant-reagent admixture from which each desired analyte may be determined. Formulations for preparation additives are also included.

Abstract: Methods for treating glutaraldehyde-fixed collagenous tissues to mitigate there propensity for subsequent calcification and to improve durability. Collagenous tissues which have been harvested and cross-linked by glutaraldehyde are exposed to a carboxyl activating agent to convert the free carboxyl (COOH) groups of the collagen molecules to activated carboxyl moieties (e.g., o-acylisourea). Thereafter, the collagenous tissue is exposed to a compound capable of reacting with the activated carboxyl moieties (e.g., o-acylisourea) to form non-carboxyl side groups. Monofunctional and multifunctional amines are examples of compounds which may be utilized to react with the activated carboxyl moieties to form such non-carboxyl side groups. Thereafter, the collagenous tissue is again exposed to glutaraldehyde. If the non-carboxyl side groups have functional amino groups (NH.sub.

Abstract: Methods for binding heparin to biological or synthetic materials which are to be implanted within a mammalian body. In instances where connective tissue proteins or other components of the material having adequate carboxyl groups present thereon, the method comprises a) contacting the material with a carboxyl-activating agent, b) contacting the material with a polyamine compound to form amide-bound polyarnine side chains at the sites of the previously activated carboxyl groups, and c) contacting the material with heparin such that heparin will become bound to the amino groups on the polyamine side chains.

Abstract: A bileaflet mechanical cardiovascular valve having a generally annular valve body and two occluder leaflets mounted within the valve body such that the occluder leaflets will move back and forth between an open configuration wherein blood is permitted to flow through the annular valve body and a closed configuration wherein blood is prevented from flowing in at least one direction through the annular valve body. Slots formed in opposite ends of the occluder leaflets are mounted upon raised mounting members formed on the inner surface of the annular valve body to facilitate the opening and closing movement of the occluder leaflets.

Abstract: An aortic valve sizing obturator apparatus for employment in determining the correct size of an aortic annulus. The apparatus includes a cylindrical obturator body with a flange member formed thereabout. At least the under surface of the flange member is of a non-planar, multi-curvate configuration to thereby be complimentary in shape to the annulus of an aortic valve when seated in the annulus during size determination. Within the cylindrical obturator body can be disposed a handle connector to which a handle can be attached during placement of the obturator apparatus within an annulus. The present invention also includes methodology for determining the size of an aortic valve annulus by employing a plurality of differently-sized aortic valve sizing obturators defined above and individually seating them sequentially within the aortic annulus until an obturator that reflects annulus size is located.

Abstract: In general, the present invention comprises an holding apparatus for facilitating implantation of a prosthetic heart valve within a mammalian heart. The holding apparatus generally comprises a cage or enclosure having a heart valve prosthesis retention space defined therewith. The proximal end of the holding apparatus is releasably attached to the proximal end of the heart valve prosthesis such that, when the holding apparatus is advanced in a forward direction, a "pulling" force will be exerted upon the proximal end of the prosthesis, rather than a "pushing" force being exerted upon the distal end of the prosthesis.