Abstract: A sewing ring for implantation of prosthetic heart valves has a compliant ring member made of a plurality of cells. The ring member may be silicon rubber and the cells defined within outer walls and inner ribs. A biocompatible fabric covering surrounds at least an outer portion of the ring member, and the assembly mounts to a mechanical or tissue-type prosthetic heart valve. The ring member has a radial dimension and cross-sectional area sufficient to ensure a large coaptation area between the sewing ring and the annulus tissue so as to enable adequate attachment of the valve without load distributing devices such as pledgets. A version of the sewing ring for attachment to the mitral annulus includes a curved coaptation edge, while another embodiment for attachment to the aortic annulus has a tapered outer edge with increased radial and axial dimensions.

Abstract: A prosthetic mechanical valve includes a base portion defining a through blood flow pathway closed by at least a pair of valve leaflets. The valve leaflets are pivotally carried by the base portion and movable in response to dynamic blood fluid pressures between a first position at which the leaflets close blood flow through the pathway and a second open position allowing blood flow in the pathway. A pair of confronting magnets are carried one to each of the pair of valve leaflets and attract one another. The magnetic forces of attraction between the pair of magnets imparts a biasing torque to the valve leaflets which tends to synchronize pivotal movements of the leaflets, cushions their sealing contact, quiets valve operation, and biases the leaflets toward a third partially open position. As a result, under conditions of nearly balanced blood fluid pressures across the pair of valve leaflet they anticipatorily open toward their third position to improve pumping effectiveness.

Abstract: A multi-lumen catheter capable of measuring cardiac output continuously, mixed venous oxygen saturation as well as other hemodynamic parameters. The catheter is also capable of undertaking therapeutic operations such as drug infusion and cardiac pacing. The catheter includes optical fibers for coupling to an external oximeter, an injectate port and thermistor for bolus thermodilution measurements, a heating element for inputting a heat signal and for coupling to an external processor for continuously measuring cardiac output, and a distal lumen for measuring pressure, withdrawing blood, guidewire passage or drug infusion. In a preferred embodiment, the catheter includes a novel lumen configuration permitting an additional infusion lumen for either fast drug infusion or cardiac pacing.

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: An annulus sizer measures the size of a valve annulus during annuloplasty surgery. The annulus sizer includes a sizing portion for measuring the valve annulus and a coupling portion for attaching to a handle. The coupling portion is disposed on a proximal surface of the sizing portion. The sizing portion has a thickness on the order of about 0.1 inch. This relatively small thickness of the sizer facilitates minimally invasive annuloplasty surgery. For example, the sizer may be inserted through a relatively small intercostal incision. In addition, the relatively thin sizing portion minimizes optical distortion. The coupling portion may be disposed on the sizing portion at a location which is offset from the center of the sizer, thereby defining an enlarged viewing area. The coupling portion may have threading to engage with threading of the handle to ensure secure attachment.

Abstract: Disclosed herein are methods for harvesting adipose tissue so as to preserve an increased population of viable microvascular endothelial cells. Adipose tissue containing microvascular endothelial cells is harvested using a collection apparatus incorporating an elongate cannula having apertures with tissue cutting edges. A sub-ambient pressure is applied to a lumen in the cannula to draw the adipose tissue through the aperture where it is then severed using the cutting edge to disrupt the connective adipose matrix. This harvesting provides a cleaner, more homogeneous sample of adipose tissue, thereby increasing the population of viable microvascular endothelial cells obtained through further processing. Rapid and easy methods for the further homogenization of the harvested adipose tissue are also disclosed.

Abstract: A vacuum-assisted venous drainage reservoir for cardiopulmonary bypass surgery with both hard and soft shell reservoirs. The system utilizes a wall vacuum or other source of negative pressure to create a negative pressure via a regulator within a sealed hard shell reservoir, or within a sealed housing surrounding a soft shell reservoir. The addition of a negative pressure in the venous return line enables the use of smaller cannulas suitable for minimally invasive surgery. The reservoir need not be positioned well below the patient as in conventional gravity venous drainage configurations, thus adding flexibility to the operating room layout and enabling a reduction in the extracorporeal blood prime volume needed. In one embodiment, a flexible membrane in the hard shell reservoir expands to contact the blood surface and reduce blood/air interactions. In another embodiment, a moisture trap is provided between the source of vacuum and hard shell reservoir to reduce environmental contamination.

Abstract: A syringe is disclosed having a large syringe housing which can be fitted with a large needle holder which in turn holds a large introducer needle. The introducer needle defines a passageway. A small seeker needle which is designed to fit within and through the passageway of the large introducer needle is attached by way of a small needle holder to a small syringe housing. A washer adapter attaches to the front of the small needle holder in order to have the small syringe housing move within a large syringe housing as a plunger for the large syringe housing. The small syringe housing in turn receives on one end a small syringe plunger which may define a small plunger lumen or chamber which can be used for transduction. Another embodiment has a modified needle having a port in the shaft within the syringe to allow sampling.

Abstract: Methods for folding a catheter mounted balloon, and delivery catheter systems which incorporate radially expandable intraluminal devices (e.g., stents, grafts and stented grafts) which are mounted on a balloon folded in accordance with this method. The method comprises generally folding the balloon at least twice, in opposite directions, so that any rotational forces created by the unfolding of the balloon as it is inflated will counteract each other, and will thus avoid substantial rotational movement of the intraluminal device during its radial expansion.

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 multi-purpose surgical implement handle has proximal and distal ends. A gripping section is located toward the proximal end, and an attachment section is located toward the distal end. An adjusting section is interposed between the gripping section and the attachment section. The adjusting section may be bent by a human user at virtually any discrete location along the section. The adjusting section may include an increased-adjustability portion which is easier to bend than other portions of the adjusting section.

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: A blood filter is disclosed which actively removes unwanted particles from the blood without using passive elements such as a cartridge. The blood filter includes a housing having a blood inlet area for receiving blood to be filtered, a blood outlet area for providing filtered blood to a patient, and a blood return area for returning blood having unwanted particles to a reservoir. A plurality of independent blood paths extend from the inlet area to the outlet area of the housing for separate flows of blood therethrough. An array of detectors is placed adjacent the exterior of each blood path for detecting unwanted particles in the blood flowing therethrough. An array of valves is placed in operable relationship with the blood paths to close selected ones of the blood paths when unwanted particles are detected. Blood return conduits open to divert the particle-containing blood to a reservoir. Several arrays of detectors and valve combinations may be provided for redundancy.

Abstract: An externally supported, tape-reinforced tubular prosthetic graft and method of manufacturing therefore. The graft comprises a tubular base graft formed of expanded, sintered fluoropolymer material, a strip of reinforcement tape helically wrapped about the outer surface of the tubular base graft and attached thereto, and, an external support member helically wrapped around the outer surface of the reinforcement tape and attached thereto. The helical pitch of the reinforcement tape is different from the helical pitch of the external support member. Preferably, the helical pitch of the reinforcement tape is in a direction which is opposite the direction of the external support member.

Abstract: A system for measuring biological functions of a patient, such as cardiac output, filters noise from a signal provided by a thermistor catheter inserted into the body of the patient. A signal-conditioning cable is disposed between the catheter and an instrument which processes the signal to measure cardiac output. The cable includes circuitry which forms, in combination with a thermistor of the catheter, a low-pass filter for attenuating thermal and high-frequency noise from the signal provided to the instrument. The instrument can more accurately measure cardiac output with the filtered signal than with an unfiltered signal. Although the circuitry which forms the low-pass filter may be combined with the catheter or the instrument, it is preferred to dispose the circuitry in a separate cable to reduce manufacturing costs of the catheter and retrofitting costs of existing instruments.

Abstract: A double lumen tubing which is adapted for use as a catheter. The tubing accommodates multiple sized guidewires and has increased resistance to kinking. A lumen wall divides the outer tubular wall into the two lumens and has a central arcuate portion shaped to allow insertion of relatively large guidewires through one of the lumens, while still leaving space for smaller guidewires through the other lumen. Resistance to kinking is increased by varying internal diameters or axes of the interior lumen walls to increase the wall thickness of the tubing in selected areas, and by varying the thickness of the wall that divides both lumens in the middle or where the dividing wall meets the outer tubular wall.

Abstract: A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body.

Abstract: Methods for rotating a heart valve body rotatably mounted within a sewing ring. The valve body includes a plurality of drive surfaces on an inner periphery, and a rotator has a plurality of drive surfaces on an exterior periphery. The drive and driven surfaces are in registration only in discrete relative orientations of the two parts about a common axis of rotation. The drive surfaces may be greater in number than the driven surfaces, to reduce the rotational angle that the rotator must be turned before registering with the valve body. The drive and driven surfaces may be formed as flats on each respective part. In one embodiment, the rotator includes a cylindrical distal end with three pairs of diametrically opposed external flats, and the valve body includes a single pair of diametrically opposed internal flats. The rotator is designed so that a surgeon need only rotate it a maximum of 90.degree. in either direction.

Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve.

Abstract: A one-handed blood sampling reservoir for an infusion line having a configuration which allows discard fluid to be drawn into the reservoir and then returned to the patient in two squeezing motions. Both drawing and returning steps are performed by squeezing two of a plurality of finger grips provided on the reservoir. The reservoir may include a bracket which enables one-handed operation in either a hand-held or a pole-mounted configurations. In the alternative, the reservoir and finger grips may be formed by telescoped inner and outer housings without a bracket. The reservoir desirably includes a syringe-like body forming a chamber and a plunger/piston assembly reciprocal therein to vary the volume of the chamber. A narrow gap is provided in the chamber open to both inlet and outlet ports when the piston is fully seated to ensure a consistent and minimum flush volume in the chamber.