Abstract: A device for delivering fluid, such as insulin, to a patient. The device includes an exit port assembly, a syringe-like reservoir including a side wall extending along a longitudinal axis towards an outlet connected to the exit port assembly, and a plunger assembly received in the reservoir. The plunger assembly includes a two-way shape memory element connecting first and second lateral segments, and having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element. Successively applying a charge and removing the charge from the two-way shape memory element causes longitudinal movement of the plunger assembly towards the outlet of the reservoir in order to cause fluid to be dispensed from the reservoir to the exit port assembly.

Abstract: A hemostasis valve for use in introducing an over-the-wire medical lead into a patient's vascular system comprises a housing with a passageway, the passageway including an elastomeric pierceable seal member interposed therein and a resilient, annular tip surrounding a distal end of the housing where the tip has a central opening that is sized to receive a tubular connector terminal at the proximal end of the medical lead for dripping the end of the lead and sealing the lead's tubular connector terminal in the passageway of the housing.

Abstract: A sequential delivery syringe which has an internal chamber located within a body with the internal chamber being substantially closed at one end except for a discharge opening and totally open at the opposite end. A luer is connected to the discharge opening with the luer including a piercing member. A mid-piston is movably mounted within the internal chamber of the syringe with there also being a separate stopper piston which is connected to plunger. Between the stopper piston and the mid-piston is mounted a collapsible structure within which is an internal chamber. A liquid is to be contained within this internal chamber of the collapsible structure.

Abstract: In an embodiment, a slit valve catheter has a generally tubular catheter body with an exterior surface exposed to an environment and an interior surface defining a lumen. The catheter further includes a valve which has a protuberance projecting radially from the catheter body.

Abstract: A drug delivery device for holding sterile medicaments, vitamins, nutrients, and the like to animals. The delivery device comprises a flexible sealed bag having at least two attachment points which serve as openings for tubing, at least two flexible lengths of tubing connected to the attachment points of the bag at one end, and adapters attached to an opposite end of each tube wherein said adapters are complementary of one another and detachably connect thereto. A method of filling and using the drug delivery device is also contemplated by the present invention.

Abstract: Bioactive agents are cutaneously delivered by a jet dispenser using inkjet technology, such as that used in printing. The dispenser propels precise volumes of bioactive agent toward the skin, where they exert a local or topical effect, or move through the skin for transdermal systemic delivery. Drugs are either delivered directly to the skin, or are introduced into a transdermal patch, which may receive repeated dosages. A controller in the dispenser may control delivery of multiple different drugs, timing of drug administration, or change drug regimens in response to a changing medical condition of a patient, such as those monitored by a sensor in communication with the controller, for example to prevent an overdose. The dispenser may act as an electromechanical patch, capable of long term administration of drugs to the skin, to achieve local or systemic pharmaceutical effects. Administration methods are also provided, along with replacement kits.

Abstract: An emergency urinal kit is provided having a urine receptacle and a pair of specifically adapted male and female collector funnels, each said collector funnel for interchangeable connection with said urine receptacle for provide fluid communication thereto. The male collector funnel forms a cylindrical flexible membrane that has a rollable sidewall and is in fluid communication with a drain tube for connection with a collection conduit. The female collector funnel forms a rigid sidewall terminating at the upper end in an upper sealing ridge forming a contoured upper edge specifically adapted to seal against the user's body when pressed against the user's groin, and is in fluid communication with a drain tube for connection with a collection conduit.

Abstract: A flexible membrane is situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate.

Abstract: A prepackaged diaper changing kit which is compact and convenient to carry and use and which is capable of being both dispensed from a conventional vending machine, as well as being displayed on shelves and sold in conventional retail establishments. A preferred embodiment of this prepackaged diaper changing kit includes a disposable diaper, at least one (1), and more preferably two (2), prepackaged moist baby wipes, a prefolded baby liner, a prepackaged instant hand sanitizer and a prefolded disposable plastic bag. These items are preferably prepackaged together in a durable waterproof outer wrapper, such as an opaque plastic outer wrap film. The prepackaged diaper changing kit in accordance with the present invention provides all of the supplies needed to change a diaper for, for example, a newborn or infant, and, when finished, allows the user to secure and discard the dirty or wet diaper, as well as the used moist baby wipes and other left over packaging materials, in a safe and convenient manner.

Abstract: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An elongate mender slidably disposed in the lumen has a distal end located proximate the distal end of the catheter. An administering tip is disposed at the distal end of the catheter and is configured to express a bolus of liquid in response to positive pressure in a distal portion of the lumen created by movement of the elongate member distally in the lumen. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in a distal end of the lumen between a distal tip of the catheter and a distal end of the elongate member. The elongate member is then moved distally within the lumen to express the bolus from the distal end of the catheter.

Abstract: Apparatus and methods for delivering an angiogenic agent to a site within the heart. Either using a percutaneous, intraoperative or minimally invasive approach, an elongated member containing an angiogenic agent is guided to a heart wall and the agent is dispensed into heart tissue. Additional fluids or substances can be dispensed in combination with the angiogenic agent to provide visualization and site mapping. In certain embodiments, the angiogenic agent is delivered adjunctively with the administration of energy, such as laser energy or RF energy which disturbs the heart tissue sufficiently to enhance the effects of the angiogenic agent.

Abstract: A preshaped tubular catheter for percutaneous transradial approach to catheterization, comprises a distal bridge shaped portion having a distal arch defining a primary curve, a top defining a secondary curve, and a proximal arch defining a tertiary curve. The proximal arch is connected to a straight shaft. The shaft is stiff and the bridge shaped portion has a flexibility extending at least up to and including the primary curve and a stiffness extending at least up to and including the tertiary curve.

Abstract: A method of performing dialysis with a, catheter system which includes (i) a working catheter having a distal working orifice, and (ii) a guide catheter having a guide lumen and a distal guide orifice is disclosed. The method includes the step of locking the working catheter in an operative position in which (i) the working catheter extends through the guide lumen of the guide catheter and out of the distal guide orifice of the guide catheter, and (ii) the distal working orifice of the working catheter is positioned outside of the guide catheter. The method further includes the step of performing a dialysis procedure including advancing and withdrawing blood through the working catheter while the working catheter is locked in the operative position.

Abstract: A filter comprising a porous material is arranged in a generally conical shape having an expandable base and a vertex. An elongate member having a proximal end and a distal end is attached to the expandable base of the porous material at a first circumferential location of the expandable base and extends perpendicularly from a central axis of the filter. An aspiration tube, for removing embolic material under vacuum, communicates with an area at the first circumferential location of the expandable base. Methods of using the filter and occluding devices for protecting a patient from embolization during cardiovascular procedures are described.

Abstract: A transdermal medication delivery device (20) for the remote controlled administration of medications (68, 70, 72) for absorption through the skin of a patient (22) includes a tubes (62) containing the medications (68, 70, 72). Tubes (62) are in fluid communication with valve inlets (76, 82, 88) of valves (74, 80, 86) formed on a micro-electro-mechanical-system-based (MEMS-based) valve chip (64, 162). A medication delivery component (26, 176) in fluid communication with valve outlets (78, 84, 90) of valves (74, 80, 86) has a surface (66, 178) adapted to be in contact with the skin of the patient (22) when in use. A controller (92) is configured to control a flow of the medications (68, 70, 72) through the valves (74, 80, 86), and a wireless communication interface (94), in communication with the controller (92), is configured to receive a medication control message (96) from a remote location (32).

Abstract: The invention provides an apparatus and method for performing surgery on a patient. The surgical apparatus includes an input device, at least one hydraulic amplifier operably attached to the input device, and an actuator operably attached to the hydraulic amplifier. Input to the input device is hydraulically modulated via the hydraulic amplifier to manipulate the actuator. The surgical method includes receiving a mechanical input for an action. The mechanical input is hydraulically modulated. The action is controlled based on the hydraulically modulated input.

Abstract: A retaining collar for laparoscopic surgery includes a compressible and elastic body that has an inner periphery and an outer periphery where the inner periphery forms a conduit for receiving and securing a tubular device. The retaining collar also includes a rigid portion attached to the compressible and elastic body. The rigid portion has an inner periphery, an outer periphery and a cam lock where the inner periphery forms an aperture that aligns with the conduit and the cam lock receives and retains a suture.

Abstract: A device for helping to correct imperfections of a cornea includes a molding lens. The molding lens includes an external surface having a concave shape to correspond to the desired shape of the cornea. Heating and cooling elements are located with the molding lens to control the temperature the molding lens, and thus to control the temperature of a substance located on the molding lens.

Abstract: A method and apparatus are provided for radiation treatment on a patient by use fiber laser and/or a tunable laser, a tunable fiber laser being used for preferred embodiments. Wavelength may be controlled to control depth of penetration and/or radiation absorption and may be scanned to scan depth of penetration.

Abstract: A tissue resurfacing system has a handheld surgical instrument with a gas conduit (38) which terminates in an exit nozzle (180N). Inside the conduit is an inner electrode (54). A tubular coaxial outer electrode (70) constitutes part of the wall of the conduit. Coupled to the instrument is a radio frequency power generator which delivers high level radio frequency energy in single-shot or repeated bursts to the electrodes (54, 70) while gas is flowing through the conduit (38) so as to create a gas plasma between the electrodes which then emerges from the nozzle (180N) for tissue treatment. A resonant focussing element (480) may be located in the conduit (38) between the electrodes (54, 70) to aid plasma striking. The combination of high peak power (e.g. greater than 750 W) and short treatment pulses (e.g. less than 30 ms) allows rapid surface treatment without significant thermal effects at unwanted depths.

Abstract: An RF treatment device according to the present invention includes one or two radio frequency electrode holders each having multiple electrodes arranged to create a transmural lesion through tissue. The treatment device is placed with one holder placed on the endocardial surface of the heart wall with the electrodes protruding towards the epicardial surface of the heart and the other optional holder placed on the epicardial surface of the heart with the electrodes protruding towards the endocardial surface of the heart forming a bipolar arrangement of equally spaced electrodes. The embodiments of the present invention are described for use in creating a transmural lesion in heart tissue to treat atrial fibrillation by blocking the passage of abnormal electrical currents through the heart. However, the devices and methods may also be used to create continuous transmural lesions in heart tissue and other body organs and tissues to treat other conditions.

Abstract: An electrode assembly that can be used to apply current to a cornea. The assembly includes a tip that is attached to a stop. The stop is pressed into an inner channel of an electrode body. The stop limits the penetration depth of the tip into a cornea.

Abstract: There is provided a surgical instrument for electrothermal coagulation of tissue, which includes a front cylinder at the distal end of the instrument having a distal tip, an elongate carrier, and two spaced cylindrical or strip-shaped electrodes at or on the carrier which are connectable to an HF-ac voltage source.

Abstract: Disclosed are methods of spinal fixation involving application of a liquid medium which cures, hardens, polymerizes or otherwise serves to bind adjacent vertebrae together. The fixation which results from this binding may be temporary or essentially permanent in duration, and may be used to treat conditions or disease of the spine, such as inflammation, instability or fracture. In a preferred embodiment, the liquid medium comprises a low viscosity cyanoacrylate-based adhesive.

Abstract: Methods and instrumentation for spinal interbody fusion are disclosed. The instruments and methods are particularly adapted for interbody fusion in an unreamed disc space. One instrument is a distractor assembly including a first distractor and a second distractor configured to be inserted in side-by-side relation in the disc space. Fusion cages adapted for insertion into an unreamed disc space are provided to enhance load distribution between adjacent vertebral bodies and lateral stability of the spinal column. The fusion cages may be inserted after distracting the disc space with the distractor assembly. Instruments for preparing the disc space through the inserted fusion cages or for use with the distractor assembly are also provided.

Abstract: A trial implant and trial implant kit for assisting a physician in selecting an appropriately sized prosthesis is provided. In one embodiment, the trial medical implant device includes a body formed from a radio-lucent material and having a size and shape adapted to fit within or adjacent to an interstitial space, and at least one marker associated with the body and formed from a radio-opaque material. The at least one marker is configured to provide an x-ray visible reference to indicate the position and/or alignment of the body with respect to an anatomical structure when the trial medical implant device is positioned within an interstitial space.

Abstract: A bone fixation plate including a plate having a first set of openings and a second set of openings, and a plurality of clip members removably fitted within the respective opening of the second set of openings. The first set of openings include a plurality of circular through holes. The second set of opening includes a plurality of elongated holes extending through the plate transverse to the longitudinal axis of the plate. Screws are fitted through the first set of openings and the second set of openings so as to engage bone portions on opposite sides of a break.

Abstract: A surgical tack for bone fixation having a body portion with barbs on the outside of the body portion to fixedly engage a bone structure, and a head portion to assist in implantation of the surgical tack. The tack also includes fins on the body portion to reduce implantation forces while not reducing the holding power of the surgical tack. The barbs extend from the fins to engage a bone structure and increase the holding force of the surgical tack. Additionally, a break-away portion is affixed to the head portion to engage an implantation device to assist an implantation of the surgical tack.

Abstract: The invention relates to a bone screw and a tool for fixing same. A bone screw has a screw element (1), comprising a screw shank (2) and a screw head (3), a cylindrical receiver part (5) with a bore coaxial to the cylindrical axis coming from one end (8) of the cylinder, an opening (6) extending cross-wise to the cylindrical axis for receiving a rod (16) to be connected to the bone screw, an inner thread (10) at one end (8) and a screw (13) cooperating with it and also an outer thread (11) at one end (8) and a nut (14) cooperating with it. Both threads (10, 11) are constructed as running in opposite directions.

Abstract: A cutting saw blade for use with an oscillatory power tool used in surgical bone cutting procedures including a blade having a distal end provided with teeth whose tips are located on a tangent line perpendicular to the long axis of the blade. The teeth are configured substantially as right triangles with their hypotenuses facing either towards the center of the blade or away from the center of the blade. A central tooth can be optionally provided.

Abstract: A method and apparatus for minimally invasive total joint replacement. The method involves sculpting the articular surface of a second bone that normally articulates with a first bone by attaching a bone sculpting tool directly or indirectly to the first bone with the tool in bone sculpting engagement with the articular surface of the second bone, and then sculpting the articular surface of the second bone with the joint reduced and moving one bone with respect to the other. An implant is placed to replace the articular surface of the second bone using an impaction device directly or indirectly attached to the first bone, wherein the force to place the implant is reacted by the second bone and the first bone.

Abstract: A rongeur having a crossbar with a cutter and a shaft with a footplate. The crossbar moves towards the footplate through movement of an actuator connected to the crossbar about an arcuate path about a first pivot. This results in a portion of the crossbar moving initially away from the shaft as the cutter moves towards the footplate to create a gap, and then back towards the shaft as the cutter contacts the footplate. A spring mechanism biases the crossbar in a ready position with a first distance separating the cutter and the footplate. When the cutter contacts the footplate, the crossbar is in a cutting position. When the crossbar is between the ready position and the cutting position, it is in an intermediate position with a gap between the crossbar and the shaft. A retainer is positioned in an engaged position to maintain the crossbar in an intermediate position for cleaning. The retainer is preferably a disposable O-ring which is disposed after each use.

Abstract: Apparatus for inserting intraocular lenses (IOLs) into eyes are disclosed. The apparatus comprises an insertion tube, and an injector rod having a distal tip capable of engaging an intraocular lens. A guide assembly is provided to direct the distal tip of the rod radially outwardly as it moves distally through the insertion tube. The radial movement of the tip is controlled such that the tip contacts a proximal edge, rather than a fold, of the IOL. The tip exerts little or no pressure on the bottom wall of the IOL cartridge, with any incidental pressure varying as the tip moves distally. In one embodiment, the guide assembly also includes a component for allowing the tip to return upward after contacting the IOL, thus decreasing or eliminating the pressure on the wall as the rod tip continues through a narrower diameter exit portion of the cartridge. Methods for inserting an IOL into an eye using such apparatus are also disclosed and are within the scope of the present invention.

Abstract: An obstetrical vacuum extractor having a vacuum cup molded of a first, relatively rigid material, with a lip of a second, relatively soft material secured along the basal opening. An elongated hollow stem which may be coupled to a vacuum source communicates with the interior and, accordingly, the basal opening of the vacuum cup. The first, relatively rigid material of the cup is preferably substantially transparent so that the physician may readily monitor the condition of the fetal scalp throughout delivery.

Abstract: A surgical manipulator (10) can manipulate a medical tool (12) with one or more degrees of freedom. In preferred embodiments, the manipulator (10) is a parallel mechanism including a plurality of arms (21, 22) pivotally supporting a medical tool (12), with the orientation of the medical tool (12) being adjusted by varying the position of joints (23, 24) mounted on the arms (21, 22). The motions of the joints (23, 24) can be controlled such that the tool (12) is pivoted about a virtual pivot point located within the body wall of a patient (30). The manipulator (10) can enhance the dexterity of an operator and enable the operator to perform medical procedures more easily than by hand.

Abstract: Devices and techniques for suturing are particularly useful in laparoscopic, arthroscopic, and/or open surgical procedures. A method of delivering a suture includes providing a suture device, releasably coupling a suture to a distal end of a suture device by threading the suture through a first region of a bounded opening of the suture device and moving the suture to a second region of the bounded opening having a dimension smaller than a diameter of the suture to trap the suture in the second region, penetrating a substrate with the distal end of the suture device such that the a portion of the suture passes through the substrate, and releasing the suture from the distal end of the suture device.

Abstract: The present invention relates to a medical device for placement at a predetermined location within a passageway of the human body, and more particularly, relates to a flexible expandable embolization device which may be delivered by a catheter to a pre-selected position within a blood vessel to thereby embolize a blood vessel or a blood vessel defect, such as an aneurysm or fistula.

Abstract: A surgical clamp system including a clamp, a delivery/retrieval device, and an actuator is provided. The clamp includes a pair of jaws actuatable relative to each other from a fully open to a fully closed position. The delivery/retrieval device is detachably connected to the clamp, and is operable by a surgeon to deploy the clamp, retrieve the clamp, or both. The actuator cooperates with the delivery/retrieval device and engages the clamp, and is operable by the surgeon to open and close the jaws of the clamp. The delivery/retrieval device and the actuator are operable to securely lock the jaws of the clamp in any position between the fully open and the fully closed positions, both during and after being detached from the delivery/retrieval device.

Abstract: A high efficiency ultrasonic surgical aspiration tip apparatus and accompanying method for surgical use. The apparatus has one or more substantially “V” or “U” shaped cuts in a contacting. The apparatus and method of use provides a cutting action at the contacting end when the tip is ultrasonically excited. The apparatus and method of use further provides a substantially uniform ultrasonic and aspiration field due to the positioning and shape of the substantially “V” or “U” shaped cuts. The aforesaid further allows a surgeon to position the ultrasonic generator handpiece at any rotational angle for provision of the benefits cited.

Abstract: A lancet body 15 is molded around a needle or blade, in which the inner end of the needle body which is unsharpened has an L-shape bend at the unsharpened end. The bend, when embedded in the plastic which forms the body of the lancet, secures the needle against removal. The method involves the bending substantially perpendicularly of the unsharpened end of the lancet needle or blade to be substantially perpendicular with the elongate body of the blade. The needle or blade is placed within a jig interiorly of the plastic mold. The jig includes spaced opposed clamps and a single orienting support to the bent portion of the needle. The body of the lancet is relieved in many areas to reduce material cost and has a molded tab cover eliminating a loose part such as a separate cover.

Abstract: One aspect of the present invention pertains to an implantable medical device for at least partially obstructing a neck portion of a vascular aneurysm. The device includes an occlusion subassembly comprising a base section and at least one lateral protrusion fixedly attached to the base section. A therapeutic agent is disposed upon at least one portion of at least one lateral protrusion.

Abstract: An improved balloon catheter seal which may be used for attaching an inflatable balloon to a catheter body, especially when the balloon and catheter body are formed from dissimilar materials. The seal is formed by applying a layer of adhesive material between the inflatable balloon and the catheter body, and crimping a retaining ring over each seal junction. The invention is especially useful when joining a compliant balloon made from silicone to a catheter body made from polyurethane.

Abstract: The present invention is directed to bioabsorbable adhesive/hemostatic formulations of a 2-alkoxyalkylcyanoacrylate and liquid or solid polymeric modifiers and adjuvant. The present adhesive formulations are useful as tissue adhesive/sealants, hemostatic agents, and as a means for patching or anastomic coupling of damaged organs.

Abstract: An apparatus for warming a portion of a human body, such as a foot of a neonatal infant, comprising an elongated, flexible pouch defining an internal chamber containing a selecting initiable heat generating material, the pouch including a first relatively longer segment and a second relatively shorter segment joined along a narrower neck region. The two segments are independently securable to, for example, the foot of an infant, the longer first segment being secured to the bottom of the foot and extending to the heel and the shorter segment extending upwardly from the heel. Independent securement may be effected by a strap secured to and extending transversely from each segment and having adhesive at a distal end thereof, one strap being wrapped over the instep of the infant to secure the larger segment and the other strap being wrapped forwardly about the ankle, the distal ends of both straps being adhered to their respect segments.

Abstract: A system and method for exclusion of an aneurysm of an aortic arch region using a graft delivery system capable of maneuvering around an aortic arch, an aortic arch graft, and an occluder system for isolating an aneurysm while occluding one or more corresponding arteries, and with bypass of those arteries being performed using one or more selected bypass grafts. The graft may be branched or branchless. The graft delivery system has a flexible sheath that is manipulated manually with the aid of a guidance system. A hoist delivery system may also be provided. The occluder system may comprise independent occluders with one or more anchor members adjacent to one end. Alternatively, the occluders can be provided as part of the aortic arch graft, either as a built-in singular self-deploying occluder or as built-in multiple occluders. A kit is also provided containing a graft, stents, occluders, and optional delivery system.

Abstract: A device is disclosed for assisting surgical operations inside a vessel, particularly for the minimally invasive explantation and implantation of cardiac valves, comprising an operating structure adapted to be implanted within the vessel, that is adapted to be fixedly and detachably joined to the inner wall of the vessel and is provided with at least one connector and/or support structure for a further instrument required for the surgical operation.

Abstract: A self-expanding metal wire stent made of shape memory alloy such as nitinol in which a plurality of spaced sections of closed cells are interconnected by straight sections of wire which may be parallel to the longitudinal axis of the stent or may be disposed angularly with respect thereto.

Abstract: An intravascular stent especially suited for implanting in curved arterial portions. The stent retains longitudinal flexibility after expansion. The stent includes a plurality of first circumferential bands containing a pattern of loops at a first frequency and a plurality of second circumferential bands containing a pattern of loops at a second frequency higher than said first frequency, alternating with said first circumferential bands and periodically coupled thereto to form cells. The high frequency elements provide a flexibility after expansions which can be repeatedly stress by the beating heart, with out exceeding the elastic limit of the stent material.

Abstract: A porous prosthesis for delivering a medication to the site of implantation is disclosed.

Abstract: A coating for a medical device is described which enhances the bio-activity of the surface of a medical device, rendering the surface substantially bio-compatible. The bio-compatible coating is formed from a composition which includes an aqueous emulsion or dispersion of a polycarbonate-polyurethane composition and an excess of polyfunctional cross-linking agent.