Abstract: A remotely controllable gastric banding device (10) for placement around the stomach of a patient for the treatment of obesity. The device (10) comprises a gastric band (10) having an inflatable chamber (16) for adjusting the inner circumference of the band (10), a pressurized reservoir (20) with a valve (31) for providing fluid to inflate the inflation chamber (16), a valve (32) for releasing fluid from the inflatable chamber (16), and a controller (41) for controlling the valves (31, 32). The controller (41) is remotely controllable from outside the patient.

Abstract: A system and method for molding the shell of a medical device or other molded article is disclosed. The system includes a multi-axis rotational molding machine in which a mold is mounted. The mold has a cavity in the shape of the article to be molded. The mold seals to hold a vacuum. In operation, silicone or other molding material is inserted into the mold, vacuum is applied to the mold, the mold is rotated about at least two axes and a molding material coats the inside walls of the mold to form the shell or other desired article. A rotationally molded medical article is also disclosed.

Abstract: An annuloplasty ring for correcting maladies of the mitral annulus that not only reshapes the annulus but also reconfigures the adjacent left ventricular muscle wall. The ring may be continuous and is made of a relatively rigid material, such as Stellite. The ring has a generally oval shape that is three-dimensional at least on the posterior side. A posterior portion of the ring rises or bows upward from adjacent sides to pull the posterior aspect of the native annulus farther up than its original, healthy shape. In doing so, the ring also pulls the ventricular wall upward which helps mitigate some of the effects of congestive heart failure. Further, one or both of the posterior and anterior portions of the ring may also bow inward.

Abstract: 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.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes an inner shaft longitudinally movable within an outer shaft, each shaft having at least one balloon and at least one lumen formed therein. The catheter prevents leaking through a biological membrane by sealing the catheter tip passageway through the biological membrane with inflatable balloons on either side of the biological membrane. Further, the inflated balloons secure the position of the catheter relative to the biological membrane and the biological space targeted for therapy or diagnosis.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes inflatable balloons which when inflated in a target segment of a biological space, create closed agent delivery pockets for the delivery or collection of agents from a defined space.

Abstract: A catheter-based material removal device includes an elongated tube having a distal material removal tip thereon. The material removal tip includes a one- or two-piece housing affixed to the tube, and a rotating member therein. The rotating member includes a screw thread for coarsely chopping material received within the housing and an outwardly projecting flange for finely chopping the material. The housing includes at least one shearing member located axially adjacent the outwardly projecting flange. The shearing member has a relatively small circumferential size and a shearing edge that removes any material buildup on the axially-facing surface of the flange. Two shearing members may be provided, one each on both the proximal and distal sides of the flange. There may be three flanges restrained within a groove formed with the housing.

Abstract: 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 glutaraldehyde and then heating the glutaraldehyde. Alternatively, methods other than heating (e.g., chemical or mechanical means), for effecting polymerization of the glutaraldehyde may also be utilized. Alternatively, the tissue may be heat treated prior to fixing thereof. Alternatively, methods other than glutaraldehyde may also be used for fixing the tissue. The biological tissue may be so treated at any time prior to implantation thereof in a mammalian body.

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 minimally invasive approach for surgery on portions of the heart and great vessels. A parasternal incision is made extending across a predetermined number of costal cartilages, e.g., a right parasternal incision extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage. One or more costal cartilages, e.g., the third and fourth, are then excised to provide access to the portion of the heart or great vessels of interest, for example between a point approximately three centimeters above supra annular ridge and the mid ventricular cavity, and a desired procedure completed.

Abstract: The present invention discloses a system and method for providing sealable access to a viscus region or hollow organ and performing surgical procedures therein. The present invention is particularly useful in providing access to a patients heart without arresting the heart. The access system comprises a tissue stabilizer to provide a stable work area in a dynamic environment. A puncture device is inserted into the tissue stabilizer, which forms a puncture hole within the heart tissue. Thereafter, a sealing device, for example a sealing balloon, is inserted through the puncture hole and engages the interior tissue. A sealing cannula may then be advanced into and sealably engages the tissue.

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 design and method of implantation is disclosed for a flexible annuloplasty system for repairing a valve in a patient's heart. The annuloplasty system includes an elongate, flexible band with a needle attached to one end of the band and a fit adjuster attached to the other end of the band. The band is made of silicone and includes a plurality of fibers that are configured to prevent axial elongation of the band. In addition, the plurality of fibers ensure that a suture will catch on the fibers and prevent the suture from tearing out of the band.

Abstract: A flexible prosthetic tissue-type heart valve having commissures that are substantially decoupled from a cusp support structure. The valve includes three leaflets having arcuate cusp edges and opposed free edges, with outwardly-directed attachment tabs therebetween. A cusp support structure in either one or more pieces attaches to the leaflet cusp edges. Three commissures are each formed partly with an axially-extending insert member to which two adjacent leaflet tabs attach. An inverted V-shaped clip maintains close contact between the adjacent leaflet tabs and provides a stress-relieving clamping action in conjunction with the insert member. The insert member attaches about its lower end to base sections of the cusp support structure, or to an intermediate sewing ring, so that the commissures may pivot about the cusp support structure. The sewing band is scalloped and enables attachment of the valve along the scalloped aortic root so as to couple the valve to the natural motion of the aorta.

Abstract: A donor heart valve sizer and method of sizing to increase the quality and yield of, and decrease the expense of fabricating, prosthetic heart valves. The sizer includes an axially-extending sizing portion sized to fit within the lumen of a donor heart valve. The sizing portion may be conical such that a resistance to further insertion is felt when the exterior of the sizing portion contacts the annulus of the valve. A measuring bracket attached to the sizing portion includes a scale aligned with the sizing portion that indicates the final expected valve size based on the position of the fresh donor valve on the sizing portion. The measuring bracket includes regions of acceptable valve sizes, and may also include regions of unacceptable valve sizes. A method of sizing includes utilizing the sizer in the slaughterhouse to reduce the overall number of valves shipped to the valve assembly facility to obtain a particular valve size.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter.

Abstract: A carrier for heart valves allows the removal of a heart valve from the carrier without manual manipulation. In addition, the carrier minimizes or substantially eliminates leaking of preserving fluid during transportation and storage. The carrier includes ajar, a rinse cage, and a holder to which a heart valve is attachable. The rinse cage includes a first engagement structure, for example, a channel, and the holder includes a second engagement structure, for example, a groove, complementary to the first engagement structure for releasably engaging therewith. A heart valve attached to the holder is disposed or suspended within the rinse cage when the engagement structures are engaged. A heart valve attached to the holder is protected not only when within the jar but also when removed from the jar. The holder has a socket for engaging with a surgical handle used to remove the valve from the jar for rinsing and implantation.

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: An improved holder, system and method for implanting a tissue-type prosthetic heart mitral valve that constricts the commissure posts of the valve and allows the user to detach the handle of the holder prior to withdrawing the holder itself. The ability to remove the handle allows a surgeon greater access to suturing the prosthetic valve to the mitral annulus. The holder may include two relatively movable plates, one of which attaches to the valve sewing on the inflow end of the valve ring and the other which attaches via sutures to the valve commissures on the outflow end. Separation of the plates places the sutures in tension and constricts the commissures. An adjusting member or adapter is interposed between the handle and holder to enable separation of the two plates and removal of the handle. The adjusting member or adapter may be packaged with the valve and holder combination, or may be sold as a separate unit, possibly with the handle, so that prior art holders can be retrofit.

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 a solid core of non-elastic material which plastically retains its shape upon natural expansion of the annulus, or after surgical expansion. A discontinuity may be positioned along the anterior side of the ring or around the posterior side.