Abstract: A device and method are provided for spontaneous electrochemical production of therapeutic species, in vivo. An active metal is implanted in the tissue. The metal undergoes corrosion, thus acting as a reducing agent to constituents in the tissue, so as to cause these constituents to form the therapeutic agents.

Abstract: A patient hydration system with an infusion subsystem which infuses fluid into a patient and a urine output measurement subsystem for measuring the amount of urine output by the patient. A controller is configured to control the infusion subsystem and is responsive to the urine output measurement subsystem. The controller includes a balancing function which controls the infusion subsystem to administer fluid infused into the patient to balance the urine output with the fluid infusion. The controller also includes a taper down function which controls the infusion subsystem to administer fluid infused into the patient at a rate less than the rate of urine output by the patient.

Abstract: The invention relates to a novel drug delivery technology. More particularly the invention relates to a method of delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient: to a throwaway or reusable device for delivering at least one therapeutic compound or a formulation comprising the at least one therapeutic compound to a patient in a manner as set out by the method; to a pioneer projectile form use in said method; to formulations for use in said method and to an injectate comprising a pioneer projectile and formulation. It also relates to a disposable component containing either a pioneer projectile or an injectate.

Abstract: An objective and reproducible system for, and method of, monitoring and/or controlling the pressure during nerve blockage injection, especially by less experienced personnel, is provided in order to decrease the possibility of intraneuronal injection. More specifically, the present invention employs a pressure sensing and/or limiting device located between an injection device (typically a syringe) and a nerve block needle whereby injection pressure during a nerve block injection can be easily and objectively monitored, thereby allowing the operator to monitor the injection pressure and/or injection speed during a nerve blockage injection procedure and to take appropriate corrective actions if abnormal pressure conditions are observed.

Abstract: A method, technique and system is disclosed for the delivery of therapeutic agents and/or into the bulk brain tissues and other parts, tissues and organs of the body, including vasculature. A novel form of coaxial catheter provides a means for implanting an outer tube into the brain, then inserting an inner tube into the outer tube and aligning them such that port holes on both of the tubes will overlap and permit a flux of the therapeutic agent to flow into the brain in such a way as to minimize the effects of trapped air, virtually eliminate backflow of the agent, and avoid the potential for additional damage to the brain since only one surgical placement of the outer tube is needed. Similarly, the method, technique system may be utilized to remove fluids or other medium from the brain, tissues, and organs to minimize the effects of escaped air or negative pressure.

Abstract: Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies.

Abstract: A medical device includes a sheath having a lumen and an elongate member disposed within the lumen of the sheath. The elongate member is moveable relative to the sheath and includes a retrieval assembly. The retrieval assembly has a collapsed position within the lumen of the sheath and an expanded position when extended beyond a distal end of the sheath. The elongate member defines a lumen configured to receive a laser.

Abstract: A system and method for controlling the inflation, ablation, and deflation of a balloon catheter is provided. The system includes a balloon catheter, a console having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted.

Abstract: Method and apparatus for treating conductive irregularities in the heart, particularly atrial fibrillation and accessory path arrythmias. An ablative catheter is positioned relative to an inter-atrial electrical pathway, or a vicinity of accessory paths such as the coronary sinus or fossa ovalis, and actuated to form a lesion that partially or completely blocks electrical conduction in at least one direction along the pathway.

Abstract: A catheter for ablating tissue is provided. The catheter comprises an elongated generally-tubular catheter body having proximal and distal ends and at least one lumen extending therethrough. A non-retractable ablation assembly is attached to the distal end of the catheter body. The ablation assembly comprises proximal and distal non-conductive tubings, each having a lumen extending therethrough and a generally tubular electrode mounted between the proximal and distal non-conductive tubings. The tubular electrode is formed of a material having shape-memory and has at least one irrigation port through which fluid can pass from the inside to the outside of the electrode. The ablation assembly further comprises a non-conductive protective tubing extending generally parallel to and along the outside of the tubular electrode. The protective tubing has proximal and distal ends extending into the proximal and distal non-conductive tubings, respectively.

Abstract: An apparatus including a tissue coagulation device that creates a current path and a stimulation electrode carried within the current path.

Abstract: A bipolar electrosurgical scraper device is provided comprising a handle, a blade having a thickness and a beveled distal end with the beveled distal end terminating distally in a scraping edge. The beveled distal end includes a first electrode and a second electrode with the first electrode and the second electrode provided along a width of the blade and spaced apart with respect to the thickness of the blade. The device also comprises a fluid passage at least one fluid outlet in fluid communication with the fluid passage.

Abstract: Devices and methods for supporting adjacent spinous processes include opposing plates movable toward one another along a cross post to contact opposite sides of each of the spinous processes, and a spacer member about the cross post contacting the adjacent surfaces of the spinous processes to resist movement of the spinous processes toward one another under spinal extension motion.

Abstract: A system and method for repairing anterior cruciate injuries in animals is disclosed. The system includes a fixture used to locate a pilot hole in a tibia, a drill guide used to locate and drill additional holes in the tibia, an angle gauge used to position the drill guide so that it is able to locate and drill additional holes in the tibia, a saw assembly that separates the proximal end of the tibia from the shaft of the tibia. The repositioned proximal end may be secured to the tibia by an optional fixation plate or by a suitable adhesive.

Abstract: The present invention provides a fixation device that includes an elongate shank defining a longitudinal axis and having at least one engaging member for applying the fixation device within tissue and securing the fixation device in the tissue once implanted formed thereon, and a drive head having a proximal end, a distal end and a radial cross-sectional geometry, where the drive head is mated to the elongate shank, and includes at least one anti-rotational member integral therewith. Fixation device kits utilizing the fixation device, and methods of fixation in tissue are also provided.

Abstract: An instrument assembly for bone drilling. The instrument assembly can include a soft tissue sleeve defining an internal channel, and an irrigation cap removably coupled to the sleeve. The irrigation cap can include a delivery port connectable to an irrigation source for delivering irrigation to the internal channel, the port in fluid communication with the internal channel.

Abstract: A bone clamp for securing a surgical instrument to a bone including a body on which the instrument can be mounted, a first and second contacting arms, each of which has a first end that is pivotally connected to the body, and a second end for gripping the bone, whenever the first and second contacting arms are connected to the body at or towards opposite ends thereof so that, when the body is positioned adjacent to the bone, the arms can grip the bone on opposite surfaces thereof, and an actuator which can be moved between engaged and disengaged positions. When the actuator is in its disengaged position, the contacting arms can pivot independently with respect to each other, and when the actuator is in its engaged position, the pivoting movement of one contact arm is accompanied by approximately equal pivoting movement of the other contact arm in the opposite direction.

Abstract: Disclosed is a determination device for the size of a cutting block. The determination device includes the connection device mounted to a tibia to be placed at a top surface thereof along an upper line of a predetermined flexion gap; a body including a slide groove on a central portion of a front surface thereof, a bent part on an upper portion thereof to be placed at a precut anterior cortex of a femur, and a plurality of graduations provided on the body to determine the size of the cutting block; a slider to be slidably engaged with the slide groove of the body and including an indicating line on an upper portion thereof, and a guide to be assembled with the slider and come into surface contact with the top surface of the connection device at a lower portion thereof.

Abstract: A milling system for use in resecting at least a portion of a joint articulation surface of a bone includes an alignment guide having a top surface and an opposing bottom surface with an opening extending therebetween. Fasteners are used to secure the alignment guide to the bone so that the alignment guide is suspended above the bone. A template is removably mounted to the alignment guide so that a plurality of guide paths extending through the template are aligned with the opening in the alignment guide. A mill extends down through the guide path and has a burr on the end thereof for resecting the bone.

Abstract: A device, method and system adapted to determine a targeting position on a surgically implantable nail adapted to be used in internal fixation of a bone, the nail comprising a distal end and a proximal end, the device including an extension rod comprising a longitudinal axis and adapted to be detachably coupled to the proximal end of the nail, a bridge member adjustably secured to the extension rod and extending radially from the longitudinal axis of the extension rod, a position of the bridge member on the extension rod being rotationally and longitudinally adjustable with respect to the longitudinal axis of the extension rod, and a targeting arm adjustably coupled to the bridge member and extending from the bridge member toward the distal end of the locking nail, the targeting arm comprising a drill guide.

Abstract: The present invention relates generally to devices and methods for delivering medical devices, such as implants, to desired tissue sites, such as the intervertebral disc. In one aspect, an intervertebral disc repair and diagnostic device that is minimally invasive and that provides precise access to the desired site is provided. In some aspects, the device and method are adapted to deliver, position and expand implants that are initially oriented and compressed for minimally invasive, yet precise and effective implantation.

Abstract: Devices and methods for removing an obstruction from a blood vessel are described. The devices are deployed in a collapsed condition and are then expanded within the body. The devices are then manipulated to engage and remove the obstruction.

Abstract: Devices and methods for removing an obstruction from a blood vessel are described. The devices are deployed in a collapsed condition and are then expanded within the body. The devices are then manipulated to engage and remove the obstruction.

Abstract: An improved sterile drape, system, and method for draping portions of a telerobotic surgical system are provided. In one embodiment, a sterile drape includes an exterior surface adjacent to a sterile field for performing a surgical procedure, and an interior surface forming a cavity for receiving the non-sterile portion of a robotic surgical system, such as a manipulator. The drape further includes a fastener coupled to the exterior surface for securing the sterile drape to the non-sterile portion of the robotic surgical system while reducing the volume of the sterile drape. Advantageously, the drape allows for quick and simple installation and increases visualization of the patient by reducing the size of the drape with more form fitting features, while allowing for freedom of movement of the manipulator.

Abstract: One method for closing an opening in tissue may include providing a substantially continuous solid staple having a plurality of tines and a longitudinal centerline, plastically deforming the staple to a splayed configuration; penetrating at least one tine into tissue in proximity to the opening; and plastically deforming the staple to a closed configuration. Another method for closing an opening in tissue may include providing a staple having a plurality of tines; plastically deforming the staple to a splayed configuration by applying force in the distal direction against a proximal surface of the staple; penetrating at least one tine into tissue in proximity to the opening; and plastically deforming the staple from the splayed configuration to a closed configuration by applying force in the distal direction against a proximal surface of the staple.

Abstract: Methods of the invention include delivering a grasper, a clip applier, and an endoscope transorally to the site of fundoplication; grasping the fundus with the grasper (or similar device, e.g. corkscrew) and pulling it into the jaws of the clip applier; closing the jaws of the clip applier over the fundus and applying a clip to the fundus.

Abstract: This invention includes a clip having arms which grip living tissue, a press tube serving as a clamping member which is fitted and mounted on the clip to close the arms of the clip, a coupling member which can be inserted into the press tube and engages with the clip, and projections serving as lock portions which hold the arms of the clip in a closed state when the clip engages with the press tube.

Abstract: A surgical clip has a base portion and two generally parallel, spaced arms extending from the base portion and defining an opening therebetween. The arms terminate distally in fingers which are of reduced width and thickness relative to the arms and which are adapted to be bent towards and past each other. A transition section from each arm to the finger provides curved structures which extending away from each other and providing a wider mouth for the opening between the arms. The arms also have a proximal section with an undercut which helps in flexure of the arms. The base is an extended structure having a rounded proximal end with outwardly extending shoulders which are arranged to be engaged by the curved structures of the mouth of another clip.

Abstract: Described are methods and systems for treating a patient to modify a body passage of the patient. The methods may involve removing tissue from a luminal surface of a body passage such as the esophagus or stomach, for the purpose of inducing a healing response that will result in a reshaping of the body passage.

Abstract: A vascular incision apparatus is composed in part of a needle for puncturing a blood vessel and a cutter for making an incision in the blood vessel. The apparatus easily, rapidly and reliably creates a vascular incision of the desired length by employing an incision length controlling means to control the length of penetration by the needle into the blood vessel, or by controlling the distance between the respective needle points on first and second needles which face each other across a given distance, one of which needles is movable relative to the other.

Abstract: A low profile, two lumen dilator is provided for an arteriotomy closure system. The dilator includes a first lumen adapted to receive a guidewire and a second lumen having a proximal segment that defines a blood marking lumen and a distal segment that receives the distal ends of stabilizers in a common pocket. The blood marking lumen and pocket are arranged in tandem. The guidewire lumen may extend the full length of the dilator or may be shortened to provide rapid exchange capability.

Abstract: A method of improving air flow through a nasal cavity includes providing an adjustable nasal cavity dilation device with a first deformable body having a shape corresponding to the nasal cavity so as to enable insertion of the device within the nasal cavity. The body includes top and bottom frame ends interconnected by a flexible wall structure that undergoes lateral deformation in response to movement of one frame end toward and away from the other, and a releasable holding member with complementary mating components that engage with the top and bottom frame ends and are adapted to adjustably maintain the top and bottom frame ends at a desired distance in a holding condition.

Abstract: A medical grasping device (10) for vascular use, having an outer sheath (12), an elongate control member (50) extending within an outer sheath (12) to a distal tip section (54), and a proximal control assembly (22) including an actuation section (24) joined to the elongate control member (50). Adjacent to the distal tip section (54) is a grasping portion (70, 70?) that is extendable from the outer sheath (12) to create loops (74, 74?) for grasping a target object (T) for repositioning within the vascular system, or for removal from the patient, with loops being retractable into the outer sheath to hold the target object against the device (10) during movement of the device. Elongate control member (50) is preferably a cannula or tube having a lumen (58) extending completely therethrough for placement over a guide wire (28) already in the patient.

Abstract: The invention relates to a device and a method for the removal of a heart valve stenosis, in which a filter catheter is arranged in a vessel section located downstream of the heart valve, and a valvuplasty catheter is arranged in the area of the heart valve. The filter catheter has in one embodiment of the invention at its distal end a radial filter which is unfolded radially until it fits up against the vessel wall. The catheter lumen is closed in such a way that blood must flow through the filter. After the filter has been unfolded, the valvuplasty catheter is inflated in the area of the heart valve to remove the heart valve stenosis, while debris and plaque which are released are collected in the filter. In an alternative membrane, the filter catheter may be sealed relative to the vessel wall by means of a sealing element, while an external filter is connected to the filter catheter to filter debris and plaque from the blood.

Abstract: A surgical access device includes a seal housing and a roller disposed in the housing and defining a working channel. The roller may be stationary or moveable within the seal housing to form both a zero seal in the absence of an instrument, and an instrument seal in the presence of an instrument. Rotation of the roller is contemplated and low-friction surfaces are discussed to reduce instrument insertion forces. Multiple rollers, wiper elements, low-friction braid, pivoting elements and idler rollers are contemplated. The rollers will typically be formed of a gel material in order to facilitate the desired compliance, stretchability and elongation desired.

Abstract: The surgical instrument includes a shaft having a distal end portion and a proximal end portion; an operative device is disposed on the distal end portion. A hand mechanism has a first handle and a second handle and is disposed on the proximal end portion. Movement of the second handle relative to the first handle actuates the operative device. A ratchet, attached to the second handle, locks the operative device and moves with the second handle. The ratchet is pivotally attached to the second handle and pivots between a locked position and an unlocked position. A biasing device biases the ratchet toward the locked position and a release mechanism for moves the ratchet from the locked position. At least one of the release mechanism and the ratchet has a feature permitting relative movement between the release mechanism and the ratchet.

Abstract: Surgical needle including a crimping zone for securing a suture to the needle. The needle is made of a hyper-elastic alloy which, after treatment, has two distinct states. One of the two distinct states allows the needle to be forced into a roughly elongated position when the needle is housed in an internal bore. Another of the two distinct states allows the needle to adopt a curved profile as a result of superelasticity or hyper-elasticity of the needle. The needle has a free end which has a tapered point which includes an inclined heel portion. The inclined heel portion is arranged on an inside portion of the curved profile.

Abstract: The present invention is related to an intervertebral stabilizing device structured to connect two adjacent vertebrae. The device includes an upper stop element engageable with an upper vertebra and a lower stop element engageable with a lower vertebra. The stop elements include mutual support surfaces adapted to allow a mutual rotation of the upper and lower vertebrae about the patient's transverse and sagittal axes and to prevent a mutual rotation of the two vertebrae about a vertical axis. The support surfaces are further adapted to allow mutual translation of the vertebrae in a single direction along the sagittal axis and to allow translation between the two vertebrae in both directions along a vertical axis. Additionally, the support surfaces are also adapted to prevent translation between the two vertebrae in both directions along the transverse axis.

Abstract: The present invention relates to a spinal fixation apparatus having a segment flexible rod for connecting pedicle screws and a transverse link for spacing out the rods, which are made from a shape memory alloy, thereby easily and simply connecting the rods and the pedicle screws. According to the present invention, it can easily and simply fit the rods to the misaligned pedicle screw, even if it may be a failure of alignment of the pedicle screws in surgery. Also, it can easily set up the transverse link on a pair of the longitudinal rods, even if the longitudinal rods are declined or are not in parallel.

Abstract: A stabilization system for implantation in a patient includes: at least first and second bone anchors, each bone anchor including a shaft extending in a respective bone insertion direction for connection to a respective bone of a patient, and a fastening member; and an elongate member comprising a first end portion, a first transverse portion extending transversely from the first end portion, a second end portion, a second transverse portion extending transversely from the second end portion, and a connecting portion extending in a longitudinal direction between the first and second transverse portions.

Abstract: A bottom-loading multi-axial bone anchor apparatus is disclosed. The apparatus includes a receiver member, a crown member, a bone anchor and a retaining member. The receiver member defines an upper opening and a lower opening, which may form part of the same opening, a channel, and a groove. The crown member and bone anchor are loaded into the lower opening of the receiver member, and the retaining member fits around the bone anchor and into the groove in the receiver member. The bone anchor is capable of multi-axial positioning with respect to the receiver member. An elongated member is placed in the channel of the receiver member, contacting the crown member, and a compression member is applied via the upper opening. The compression member presses down on the elongated member, which presses down on the crown member and locks the bone anchor between the crown member and the retaining member.

Abstract: A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. A heat source is provided in thermal communication with the interior of the balloon. The balloon is positioned at a treatment site while in a flexible, low crossing profile configuration. The balloon is thereafter inflated with a hardenable media, and heated to accelerate hardening of the media. Methods and delivery structures are also disclosed.

Abstract: Disclosed are methods and devices for accessing and treating the spine, while minimizing trauma to surrounding tissue. A device is introduced through tissue, to an access point on the spine. The device is thereafter advanced axially within the spine, from the access point across a treatment zone. In one embodiment, the device comprises an articulating spinal implant comprising a first elongate segment, a second elongate segment, and an articulating joint between the first and second segments.

Abstract: A fixation system (10) includes a device having a nail portion (12) and a plate portion (14), preferably horizontally and vertically offset relative to the nail portion by a neck portion (16). The nail portion (12) includes preferably threaded screw holes (24, 26), and the plate portion (14) includes longitudinally displaced peg holes (50, 52, 54), each of which is adapted to orient a peg (56, 58, 60) in a different orientation from the others. The system (10) also includes unicortical screws (28) having a reasonably large head (36) adapted to seat against the outer surface of the bone and a threaded shaft (32) adapted to engage in the screw holes (24, 26), and pegs (56, 58, 60) adapted to engage in the peg holes (50, 52, 54). Where threaded screw holes (24, 26) are used, bone is clamped between the nail portion (12) and the head (36) of the unicortical screws (28, 30). The pegs (56, 58, 60) provide stabilization and support for subchondral fragments.

Abstract: A sliding bone support plate assembly comprises at least first and second plates which slide with respect to each other, varying the length of the plate assembly by plate-on-plate sliding after bone screws mount the plate assembly to vertebrae in a recipient. The plates comprise cooperating sliding structures which cooperate with each other to interconnect the plates to each other and to facilitate sliding movement of the plates with respect to each other. Such sliding accommodates varying the length of the plate assembly, and relieving stress which would otherwise be imposed on the plate assembly by post-procedural settling of respective vertebrae to which the plates are mounted without requiring any movement of a plate with respect to a bone to which that plate is mounted. The plate assembly is fabricated using bio-compatible, bio-stable materials which are safe for extended use in a living human, and which are not generally assimilated.

Abstract: A retention system for maintaining a screw to a vertebral plate. One or more screws extend through apertures within the vertebral plate. A cavity is positioned adjacent to and overlaps into the aperture. A ring is positioned within the cavity and held in position by a cap. The cap attaches to the plate to prevent removal of the ring. The ring is deflectable between a first shape to allow the screw to be inserted and removed from the aperture, and a second shape to prevent screw back-out from the aperture. A method of using the system is also included and comprises positioning the ring within a cavity in the plate, maintaining the position of the ring to the plate by attaching a cap, inserting a screw through the aperture and attaching the plate to a vertebral member, and positioning the ring over the screw head and preventing the screw from backing-out.

Abstract: A refrigerant-containing bladder or container is positioned underneath the body. Heat absorbed from the body vaporizes the refrigerant, which expands to cooler remote regions of the bladder. Heat is then withdrawn from the edges of the container by thermally conductive pathways that distribute heat from this container to a cooler area that is not underneath the body. The cooled refrigerant condenses, and is returned to the regions of the device that are under or adjacent to the central and warmest parts of the body. The heavier and warmer portions of the body force the bladder to the lowest point. Alternatively, heat is transferred from the body via a specific highly thermally conductive layer or layers of material(s) that is (are) soft, pliable, and comfortable to sit or lie on. This layer joins conductive materials that are configured to transport heat and diffuse it to the cooler environment.

Abstract: According to an aspect of the invention there is provided an apparatus for deploying a fistula device. The apparatus comprises an elongate cover member having a proximal end and a distal end, and an elongate support member within the cover member for supporting the fistula device and configured for relative movement with respect to the cover member so as to release the fistula device at a desired location.

Abstract: A device is for introducing a stent into a hollow organ, in particular into the gastrointestinal tract of the body of a patient. The device includes a magnet system which covers the area of treatment of the patient and generates a 3D gradient field for remote-controlled movement and orientation of an endorobot. The endorobot is provided with a linear magnet and is freely movable in the hollow organ. Further, the stent, which can be uncoupled from the outside, is secured to the endorobot in a folded-down state so that it can be brought to the site of use and can there be opened out so as to bear firmly on the wall of the hollow organ.

Abstract: An expandable and retrievable stent is disclosed herein. The stent includes an inner strut, a first traveling anchor movably attached to the inner strut and a second anchor secured to the inner strut. The stent further includes frame connected to the first traveling anchor and the second anchor wherein the frame has at least a radially compressed configuration and a radially expanded configuration. The stent may also include a generally cylindrical sleeve.