Abstract: Methods and apparatus are disclosed for removal of biological tissue slices or layers, preferably in the form of lamellar sections of predetermined shape and thickness employing a reference member that engages a target tissue site and cooperates with a cutter in order to remove the tissue segment or lamella. The cutter can include a flexible cutting element such as a wire or band element that is brought into physical contact with a guiding edge integrated with, or otherwise coupled to, the reference member. Alternatively, the cutter can include a stiff rigid blade element that is maintained in contact with the guiding edge. The cutter is drawn along a path defined by the guide edge through the tissue to sever, at least partially, a tissue section. In one particularly useful aspect of the invention, devices for keratectomy are disclosed employing an ocular reference member that engages the upper central region of the cornea and cooperates with a cutter to remove a lamellar segment from the cornea.

Abstract: The present invention provides catheter apparatus and catheterization methodology for generating an arteriovenous fistula or a veno-venous fistula on-demand between closely associated blood vessels and at a chosen anatomic site in-vivo. The catheter apparatus is preferably employed in pairs, each catheter of the pair being suitable for percutaneous introduction into and extension through a blood vessel. The catheterization methodology employs the catheter apparatus preferably in conjunction with conventional radiological techniques in order to place, verify, and confirm a proper alignment, orientation, and positioning for the catheters in-vivo prior to activating the perforation means for generating a fistula.

Abstract: A bioabsorbable soft tissue anchor system comprising a cannulated soft tissue anchor for being turned through soft tissue, and a driver for driving the anchor and method for attaching soft tissue at a selected site of implantation. The soft tissue anchor is an elongated unitary body having a threaded distal section, a non-threaded proximal section, a transverse proximal head and a non-circular axial throughbore. The threaded section has a cancellous-type thread which has a uniform minor diameter, a large pitch and a large major diameter, the distal end of the thread being tapered toward the distal end of the anchor. The proximal end of the threaded section abuts the non-threaded section which is tapered and extends proximally to the transverse head. The anchor is used with a driver having a driving shaft with a pointed tip and a cross-section adapted to engage the anchor's axial throughbore.

Abstract: A stent delivery system for delivering a stent comprising, a stent disposed on the distal end of the catheter, and an inner core, wherein the inner core is resistant to appreciable compression or accordion. The catheter further comprising a first sheath covering a portion of the inner core, wherein at least a portion of the distal end of the inner core is left uncovered by the first sheath, a retractable sheath which covers at least a portion of the stent and a portion of the distal end of the inner core and a retracting means for retracting the distal sheath to release the stent.

Abstract: An assembly for delivery and deployment of an inflation expandable stent within a vessel is comprised of a catheter, an inflation expandable stent, an expandable balloon, and a fugitive stent mounting device within the balloon. The assembly is used in a method for delivering and deploying a stent.

Abstract: Apparatus for inserting intraocular lenses (IOLs) into eyes comprises a tube, a rod having a distal end portion, and a tip carried by the distal end portion. The tip is softer than the distal end portion of the rod. Methods for inserting an IOL into an eye using such apparatus are within the scope of the present invention.

Abstract: A guide wire including a radiopaque distal region having a wear resistant surface suitable for carrying the rotating drive shaft of an atherectomy device. One guide wire is formed of a stainless steel shaft having a radiopaque layer over the distal region, the radiopaque layer including a harder gold alloy over softer gold or a gold alloy layer. The harder gold alloy provides a harder, less flexible, wear resistant surface while the softer gold layer provides a softer, more flexible, less wear resistant surface. Limiting the thickness of a harder gold alloy layer can limit problems caused by flexing the distal region and problems increased by residual stresses existing within the layer. One distal radiopaque layer includes alternating layers of harder and softer gold alloys. Another distal radiopaque layer increases flexibility by having longitudinally discontinuous harder gold alloy bands, such as rings or a helical spiral.

Abstract: A bifurcated stent for insertion into a bifurcated vessel such as a blood vessel. In one embodiment, a first sheet is formed into a first leg, a second sheet is formed into a second leg, a third sheet is formed into a stem, and the two legs are attached to the stem. In a second embodiment, a first sheet is formed into a member having a first leg and half of a stem, a second sheet is formed into a second member having a second leg and half of a stem, and the two stem halves are combined to form the bifurcated stent. In a third embodiment, the stent comprises two sections that are serially inserted and assembled within the vessel at the site of the bifurcation to be treated.

Abstract: Apparatus for clearing lumens of thrombolytic material, comprising a motor including a control therefor operable using one hand holding the motor; an elongated wire connected to the motor for rotation by the motor; a catheter for enveloping a length of the wire; and a grip facilitating manual rotation of the catheter by the one hand independently of the wire as the wire is rotated by the motor at a speed sufficient to create a standing wave in a portion of the wire extending from the catheter.

Abstract: Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: A flexible, elongate probe having a distal end for insertion through physiological tissue, preferably through a lumen in the tissue. The probe includes a sensor, which generates signals indicative of a characteristic of the tissue in a vicinity of the probe, and an alignment mechanism, which deflects the distal end of the probe in response to the signals. The signals may be indicative of obstructions or of the direction of a clear channel in the lumen. The sensor preferably comprises one or more ultrasound transducers.

Abstract: A suture having a coating thereon of an ethylene-propylene copolymer, and a method of coating a suture which comprises the steps of coating the surface of the suture with an effective amount of a solution of ethylene-propylene copolymer in an organic solvent, and then removing the solvent from the coated suture. The copolymer preferably has an average molecular weight of from about 25,000 to about 500,000 g/mole, and a mole percentage of about 55 to 70 percent ethylene and about 30 to 45 percent propylene. The coating provides an alternative to silicone, which has previously been used as a coating for sutures, and exhibits excellent performance properties, such as tactile smoothness, pliability, and knot tiedown performance.

Abstract: A surgical instrument for excising a targeted tissue mass to be biopsied from adjacent bodily tissue on a surgical patient is disclosed. The instrument has an elongated tube and a tissue penetrating spiral having a spiral lumen therethrough mounted within the elongated tube for rotational movement. When the spiral is rotated, it penetrates distally into the targeted tissue mass. The mass is received in the spiral lumen for subsequent excision of the mass to be biopsied. A large biopsy sample can be obtained because of the ample space within the lumen of the tissue penetrating spiral. Since a large biopsy sample can be taken, the number of samples which need to be taken is minimized, and the consequent trauma to the patient is significantly reduced.

Abstract: A system and method for opening a lumen in an occluded blood vessel, e.g., a coronary bypass graft, of a living being. The system comprises an atherectomy catheter having a working head, e.g., a rotary impacting impeller, and a debris extraction sub-system. The atherectomy catheter is located within a guide catheter. The working head is arranged to operate on, e.g., impact, the occlusive material in the occluded vessel to open a lumen therein, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, through the guide catheter to create a differential flow adjacent the working head, whereupon the debris is withdrawn in the infusate liquid and blood for collection outside the being's body.

Abstract: A stent for insertion into a heart wall for Trans Myocardial Revascularization (TMR) thereof. The TMR stent provides for the delivery of blood nutrients from a heart chamber into the heart wall and has an elongated body which may contain a cavity and openings through the elongated body from the cavity. The elongated body should be in fluid communication with the heart chamber. If a cavity and openings are provided, the openings are in fluid communication with the heart chamber, the cavity and the heart wall. The TMR stent may include an anchoring element integrally formed thereon for securing the TMR stent in the heart wall.

Abstract: A vena cava filter and placement set includes features which can be visualized solely utilizing sonography. A method of implanting a vena cava filter employs sonography to enable the surgeon to direct the filter to a desired location and ensure that the filter is properly deployed.

Abstract: Methods and devices for harvesting blood vessels using balloons to dissect and mobilize the blood vessel from surrounding tissue are disclosed. A tunnel is created over the blood vessel. The tunnel is insufflated. A balloon dissector is inflated over the blood vessel. Side branches are then ligated and divided from the blood vessel. In a further aspect of the invention, the balloon may be an everting balloon which, upon inflation, advances along the blood vessel and envelops the blood vessel.

Abstract: A basket-type grasping tool, adapted for use in combination with an endoscope, for capturing a foreign material or the like into a basket section. Axially corresponding portions of elastic wires are each twisted in the same direction about a center axis of a basket section. Guide paths, through which the elastic wires respectively pass, are formed on an inner face of a tip-end mouth of a sheath.

Abstract: The improved medical instrument is adapted to remove obstructions from ear canals, nostrils and endotracheal tube airways. It includes an elongated handle with an elongated hollow tube connected to the front end thereof and an elongated flexible wire extending from the front end of the tube. The front end of the wire is curved to form a scoop for removing obstructions from a lumen. In one embodiment the wire and tube are removable as a replaceable unit from the front end of the handle. In another embodiment the handle has a central cavity therein communicating with the cavity in the tube and through both of which the wire extends. The wire is connected to a spring which extends out of the handle. The spring biases the wire into the tube. When the wire is manually depressed the front end of the wire extends out of tube and curves into the desired scoop configuration. The instrument can include a light which is switched on when the wire extends out of the tube and which is used to light the lumen.

Abstract: A hand-held fetal vacuum extractor combines a pump and handle into a single hand-held unit. This enables a single operator, such as a doctor, to control vacuum using a vacuum pump, and apply traction to a fetus using a single hand. A handle, having a surface for gripping, is connected to a fetal vacuum cup for being suctioned onto a fetal head. A vacuum pump is connected to the handle and includes an activation surface for activating the vacuum pump. The vacuum pump is fluidly coupled to a the vacuum cup and fetal head. The grip surface of the handle and the activation surface of the pump are in such proximity, during operation, that a single human hand can simultaneously grasp the grip surface and contact the activation surface.