Abstract: The present invention relates to a prosthetic knit based on at least a first yarn of biocompatible polymer material defining first and second opposite and openwork faces, and on at least a second biocompatible and heat-fusible monofilament yarn, forming barbs that protrude outwards from at least said first face and are obtained by melting loops generated by said second yarn, the chart followed for the knitting of said first and second yarns on a warp knitting machine having three guide bars B1, B2, B3 being the following, according to the ISO 11676 standard:—Bar B1: 1.0/0.1//—Bar B2: 1.0/7.7/6.6/7.7//—Bar B3: 2.1/5.5/3.4/0.0// said second yarn following the chart of bar B3. The present invention also relates to a process for manufacturing such a knit.

Abstract: The invention relates to a medical device for the reconstruction of parastomal hernias and/or for the prevention of their development, which has sheets (1, 2) made from plastic compatible with living tissue placed in the abdominal wall (6) connected via a linking-separating element and running separated at a distance (a) from each other. The linking-separating element is formed by a tube member (3) open at both ends forming a channel to make it possible to extract the large intestine (7) out of the abdominal cavity (9) through the abdominal wall (6). At least the tube member (3) is made from an adhesive plastic suitable for creating an organic connection with live tissue. The essence of the device is that the musculo-aponeurotic layer (6a) of the abdominal wall (6) in the vicinity of the tube member (3) is fixed to the sheets (1, 2) via fixing elements (4).

Abstract: An implant to repair a hole in a muscle wall includes a flat mesh with a central resilient core which deforms to place the core in a hole in a muscle wall and then resiliently expands when released to urge against the perimeter of the hole, dynamically “riding” in the hole as the hole perimeter expands and contracts. Straps on the mesh are tunneled through tissue in the muscle wall containing the hole to hold the mesh with core in place.

Abstract: A tissue fastener production method of clamping two living tissues together by bringing the two living tissues into close contact includes the following steps: fixing one end of a wire material made of a metal to a shaft body, and winding the wire material around an outer periphery of the shaft body while twisting the wire material round an axis of the wire material, thereby forming a coil on which a predetermined force is exerted in the winding direction; heat treating the wire material to impart superelasticity thereto; and deforming the wire material to which the superelasticity is imparted in a range in which the wire material is elastically deformable, and reversing the winding direction of the coil in a direction reverse to the winding direction of the coil wound in the step of forming the coil so as to obtain an initial tension corresponding to the predetermined force.

Abstract: The present invention is directed in various methods, devices and systems relating to rotational atherectomy. More specifically, an oscillating driver is connected to a drive shaft, or torque transfer tube, with abrasive element mounted thereon. The result provides a rotational working diameter for the rotating abrasive element that is larger than its resting diameter. Generally, the preferred abrasive element is concentric in profile and/or with center of mass collinear with the drive shaft's rotational axis. However, eccentric abrasive elements, both in terms of offsetting center of mass and/or geometric eccentricity may also be employed.

Abstract: In various embodiments, a surgical console may include a pneumatic valve to drive a pneumatic tool coupled to the surgical console. The console may further include a controller operable to control and adjust the valve open/close cycle times according to a valve duty cycle. The valve may switch between ports (valve open time for a first port and valve close time for a second port) such that a total valve time may approximately equal the valve open time plus the valve close time. The valve duty cycle may indicate a percentage of the total valve time for the controller to signal the valve to open and may include an adjustment that corresponds to a signal timing of the open and/or closed valve positions that will result in open and closed operating pressures above a predetermined threshold.

Abstract: The present invention discloses a rongeur type bone and cartilage removal device incorporating first and second pivotally secured handles, the first handle terminating at a forward end in a first jaw exhibiting a plurality of extending teeth, with second handle terminating in a second jaw opposing the first jaw and exhibiting a continuous blade edge against which the teeth seats during pivotal motion of the jaws.

Abstract: A system for repairing cartilage includes a trephine having a passage extending along a longitudinal axis of the trephine. The trephine has a distal end and a proximal end. The distal end includes a cutting member operable to cut a cartilage plug from a donor site. The passage is operable to receive the cartilage plug. Also, the trephine is flexible to selectively move between a first position in which the longitudinal axis is substantially linear and a second position in which the longitudinal axis is nonlinear. Moreover, the system includes a guide tool that is removably coupled to the trephine. The guide tool is operable to selectively move the trephine between the first and second positions. In addition, the system includes an ejector tool that ejects the cartilage plug from the passage toward a defect site.

Abstract: Lancet device including a first housing. A first guide wall is disposed within the first housing. The first guide wall includes an opening. A cap removably mounted to the first housing. A needle holding member for holding a lancet. At least a portion of the needle holding member being able to move within the opening. A first spring for biasing the needle holding member toward an extended position. The first spring surrounding a portion of the needle holding member and being disposed between the first guide wall and a shoulder of the needle holding member. A movable trigger having a first position and a second position. A movable second housing including a proximal end, a distal end and a second guide wall arranged at the proximal end. The second guide wall including an opening. A portion of the needle holding member being able to move within the opening of the second guide wall.

Abstract: Embodiments include a fiducial deployment system. A fiducial may include dimples to enhance echogenicity and/or to provide for engagement with a delivery cannula or stylet. The needle system may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time, when the fiducials are coaxially disposed around a central deployment member that may be embodied as a delivery cannula or stylet. In certain embodiments, echogenic placement of fiducials may present certain advantages. An elongate structure may be included that is configured to distally advance fiducials along the deployment member.

Abstract: An obstruction device (10) including an obstruction disc (12) mounted on a proximal portion of a shaft (14), the disc including an inner radial portion (16) and an outer radial portion (18), wherein the outer radial portion is more bendable than the inner radial portion.

Abstract: In a method for intermittently occluding the coronary sinus, in which the coronary sinus is occluded using an occlusion device, the fluid pressure in the occluded coronary sinus is continuously measured and stored, the fluid pressure curve is determined as a function of time, and the occlusion of the coronary sinus is triggered and/or released as a function of at least one characteristic value derived from the measured pressure values. The pressure increase and/or pressure decrease per time unit each occurring at a heart beat are used as characteristic values.

Abstract: Assemblies, kits, and methods for occluding a vascular vessel, such as a varicose vein, are disclosed. An assembly can include a removable inner member, a removable outer member, and an elongated expandable member positioned in a compressed form between portions of the inner and outer members. To facilitate their removal, one or both of the inner and outer members can include a handle coupled to a proximal end. The elongated expandable member can include a gelatin material or a collagen material that is configured, when wetted, to expand from a compressed first diametrical size to a second larger diametrical size within a time period of 5 minutes or less. At the second larger diametrical size, the gelatin or collagen material can occlude a vascular vessel for a period of at least 20 days without degrading.

Abstract: This disclosure contains methods, devices, and systems for object removal from a body, including removal of a stent from a body. Some methods of the present disclosure include inflating a balloon on a catheter, engaging a stent with a socket defined by a surface of the balloon, the surface inwardly sloped toward a lumen of the catheter, and retracting a portion of the stent through the socket and into the lumen. The present disclosure also includes methods for making a catheter, including forming a balloon, inverting a portion of the balloon, and attaching the balloon to a catheter such that a surface of the balloon defines a socket that is inwardly sloped toward a lumen of the catheter.

Abstract: A device for containing emboli within a left atrial appendage of a patient includes a frame that is expandable from a reduced cross section to an enlarged cross section and a slider assembly. There is provided in accordance with various embodiments of the present invention methods of preventing retention anchors from projecting outside of the native diameter of the frame, thus facilitating recapture of the device.

Abstract: The present invention relates generally to devices and methods for retrieving or manipulating objects within a lumen. More specifically, embodiments of the invention relate to devices and methods for retrieving or manipulating medical devices from a body lumen. One embodiment of the present invention provides a novel and improved retrieval snare and method of fabricating and using the same. The snare includes a snare wire, having a distal end and a proximal end, for use in the human anatomy, such as but not limited to blood vessels, pulmonary airways, reproductive anatomy, gastrointestinal anatomy, and organs such as the kidneys or lungs. The device enables a user to capture a foreign object located within the human anatomy, grasp said object in a controlled manner, and retrieve and remove said object from the human anatomy.

Abstract: A method and device of reducing and preventing snoring and sleep apnea is disclosed. The device includes a belt of sufficient length to wrap around a person's torso and of sufficient width to overlap the person's abdomen and a fastening and tightening mechanism, such as a strap and buckle, attached to the belt configured and arranged to tighten the belt. The belt is positioned around a person's abdomen. The belt is then tightened with the fastening and tightening mechanism, sufficiently to apply pressure to the person's abdomen, applying specific pressure beneath a person's diaphragm. The fastening and tightening mechanism is then fastened to prevent loosening of the belt.

Abstract: An intraoral acupressure apparatus and method of treating a user are disclosed. The apparatus may include a base shaped to conform to a palate of a user, the base configured to be removably held adjacent to the palate in a predetermined position relative to acupressure points located on the user's palate. The apparatus may additionally include one or more projections extending out from the base and configured to contact one or more acupressure points of the user's palate when the apparatus is removably held in the predetermined position. The base may be configured to be removably held in the predetermined position without wire hooks or clasps.

Abstract: A medical device includes a one-piece resiliently biased band of base material having opposite first and second side surfaces and an adhesive material for temporarily adhesively securing the band to a user's skin. The band can include a longitudinal axis and a lateral axis that intersects the longitudinal axis. Moreover, the band can include first and second lateral portions disposed on opposite sides of the lateral axis. The lateral portions are mirror images of each other such that the band is symmetrical relative to the lateral axis. Each of the lateral portions include a central portion and first and second extending portions spaced apart from each other on opposite sides of the longitudinal axis of the band and extending away from the central portion. Each of the extending portions further includes a perimeter edge defining a portion of a perimeter edge of the medical device.

Abstract: A surgical hand grip for a surgical tubular shaft instrument is provided. The hand grip includes a coupling device for coupling to a tubular shaft tool having a tubular shaft and a force transmission element movable back and forth relative thereto. The coupling device has a coupling element for coupling to the force transmission element and a connecting element for connecting to the tubular shaft. A gripping device is connected to the coupling element and is transferable from a non-actuating disposition into at least one actuating disposition and vice versa thereby changing the mutual relative spacing between the coupling element and the connecting element. The hand grip has a guiding device with a guiding body for guiding the coupling element during the transfer from the non-actuating position into the at least one actuating position along a grip axis independently of the disposition of the gripping device during the transfer.

Abstract: Filamentary fixation devices may be used in a variety of surgical procedures to secure soft tissue to bone. The present invention provides various devices, systems, kits and instrumentation for performing such surgical procedures including preparation of soft tissue and bone, preparation and manipulation of such filamentary fixation devices, and insertion and utilization of the fixation devices within a patient's anatomy. In one embodiment, a method for securing soft tissue to bone, the method includes accessing the soft tissue and the bone, passing a filament through the soft tissue, preparing a bore hole in the bone, loading the filament into a filamentary fixation device, implanting the filamentary fixation device, with the filament, into the bore hole, and tensioning the filament so that the filamentary fixation device and filament are secured within the bore hole.

Abstract: A method of closing a tissue wound includes providing a wound closure device having a first anchor, a second anchor, and a flexible member movably attached to the second anchor, positioning the first anchor against tissue, passing the flexible member across the wound, positioning the second anchor against tissue, and pulling on a free end of the flexible member to shorten a length of the flexible member between the first and second anchors, thereby closing the wound. A wound closure device includes a first anchor, a second anchor; and a flexible member connecting the first anchor to the second anchor, the flexible member being movably attached to the second anchor, such that pulling on a free end of the flexible member shortens a length of the flexible member between the first and second anchors.

Abstract: Assemblies, devices and methods are provided for suture management associated with surgical procedures for anchoring suture to bone. Suture elements mounted to suture anchors are terminated in suture loops or tags, and associated stop members that in combination with visual coding provide suture identification, prevent accidental unmounting of suture from suture anchors, and reduce the number of suture legs requiring active management during complex arthroscopic repairs. The present invention also provides exemplary drivers that can be used with the various methods and devices disclosed herein, or with other methods and devices known in the art.

Abstract: An anterior cervical plate system is provided. The cervical plate includes a retention ring with a deflectable flange that is upwardly spaced from the top surface of the ring and configured to prevent an inserted bone fastener from backing out of the plate. The plate includes a locking pin having a camming surface and a blocking surface. When the camming surface is moved into position adjacent to the flange, the flange is free to flex out of the way of a bone screw being inserted into or removed from the plate. When the blocking surface is positioned adjacent to the flange, outward deflection of the flange is prevented to retain the bone screw inside the plate. The locking pin is rotated through a camming surface to bring a blocking surface against the flange deflecting the flange onto the head of the bone screw.

Abstract: Methods of correcting a spinal deformity, including securing a first rod on a first side of a spine, securing an anchor on a second side of a spine, securing a lateral coupling between the rod and the anchor, translating and/or derotating the spine and securing a second rod on a second side of the spine to provide secondary stabilization to the spine.

Abstract: A polyaxial screw body includes a side wall defining a lumen having a first end and a second end. An opening disposed at the first end of the lumen, includes an interior surface disposed in the side wall thereabout. The interior surface is adapted to accommodate a head portion of a pedicle screw. A transverse channel extends from a first aperture through the side wall to a second aperture and is adapted to accommodate a portion of a fixation rod therebetween. A lateral connector extending integrally from the side wall.

Abstract: A spinal screw assembly adapted to be secured to a vertebrae for providing securement across at least two vertebrae. The assembly includes a pedicle screw having a substantially spherical head portion, a threaded shaft portion, and an engagement surface in the head portion for driving said screw into the vertebrae, and a body member comprising a tower portion having an open top, a break-away section for manipulation of the screw upon implantation into the vertebrae, a base body at a proximal region of the body member and a break zone which acts as a transition between the base body and the tower portion. A resealably securable setscrew within the body member secures and fully contains the rod within said assembly. The break-away section remains completely outside a wound and is removed or broken off once the screw has been fully assembled inside the vertebrae.

Abstract: An implant having a receiver that is adapted to receive a polyaxial screw in the bore and either an internal or external cap. The cap can be an external or internal cap and the implant further has at least one locking aid in the form of at least one of a tactile feedback, a visual feedback or an enhanced fixation between the cap and a rod that is received in the receiver.

Abstract: An anchoring element for a stabilization device for bones or vertebrae, with which a bone or vertebra can be connected to a rod-shaped element is described. By providing for at least one degree of rotational freedom between the rod and an anchoring element that is firmly connected to the bone or vertebra, the transfer of torque (M) onto the anchoring element and can be prevented as well as loosening or even separation of the bone anchoring element from the bone or vertebra. Moreover, the invention provides a stabilization device, in which such bone anchoring elements are used.

Abstract: A locking assembly for securing a rod in a polyaxial bone anchoring device includes a first locking element having a first end, a second end, an outer surface with an external advancement structure, an inner wall, an internal advancement structure on the inner wall, and an engagement portion for a tool, and a second locking element having a first end configured to be oriented towards the first end of the first locking element, an opposite second end, an outer surface with an external advancement structure configured to cooperate with the internal advancement structure of the first locking element, and a portion at the second end having a width greater than a greatest width of the external advancement structure of the second locking element, wherein the second locking element is configured to move axially relative to the bone anchoring device at a speed different than the first locking element.

Abstract: In a first broad aspect, there is provided herein a bioactive device and system for fusion between two bones, two parts of a bony joint, or a bony defect, such as of the spine. The fusion device includes a screw having a head and a threaded shaft. The fusion device also includes a bone dowel having an internal bore of which at least a distal portion is threaded to engage the threads of the screw shaft. The bone dowel is made of a bone-like, biocompatible, or allograft material to provide a layer of bone-like, biocompatible, or allograft material between the screw and the spinal bone. The device is generally coaxial and is further described in the drawings and description herein.

Abstract: A method of providing spinal stabilization is provided herein. More specifically, the method includes positioning a plurality of fixation assemblies within a plurality of vertebrae in a trans-lamina orientation wherein each fixation assembly includes a proximal portion configured to securely receive a stabilization element (e.g., a stabilization rod). The proximal portions of the various fixation assemblies can be aligned so as to secure at least one stabilization element in a desired position (e.g., along and above a midline of the patient's spine, adjacent and parallel to the midline). A system for providing spinal stabilization is also provided which utilizes trans-lamina delivery and positioning of fixation assemblies within target vertebrae thereby providing stronger fixation and a significant reduction in associated tissue damage.

Abstract: The present application relates to a cross pin fixator device comprising a plate member with spherical cavities that are open to the front and to the back of the plate, collapsible pin holder members having a central channel for insertion of a bone pin, the collapsible pin holder member being press-fit into the spherical cavities, and bone pins individually inserted into the central channel of a pin holder. The application also relates to a method for treating a fracture of the proximal humerus using the proximal humerus cross pin fixator and to a kit for treating a fracture of a bone.

Abstract: A soft tissue fixation system, most typically applicable to orthopedic joint repairs, such as anterior cruciate ligament (ACL) knee repair procedures, comprises an implant which is placeable in a tunnel disposed in a portion of bone, wherein the tunnel is defined by walls comprised of bone. A first member is deployable outwardly to engage the tunnel walls for anchoring the implant in place in the tunnel, and a second member is deployable outwardly to engage tissue material to be fixed within the tunnel. The second member also functions to move the tissue material outwardly into contact with the tunnel walls to promote tendon-bone fixation. Extra graft length is eliminated by compression of the tendon against the bone at the aperture of the femoral tunnel, which more closely replicates the native ACL and increases graft stiffness. The inventive device provides high fixation of tendon to bone and active tendon-bone compression.

Abstract: The device includes tubular elements capable of being temporarily fastened at the level of pedicle screw heads arranged to be connected by an implantable curved rod, and at least one rod intended to be movably inserted into slots of each tubular element, to align them for the correction of the spinal column by translation, tilting, and rotation of the vertebrae in the three planes of space. Each tubular element is configured in such a way that it can be coupled with the outside of the pedicle screw heads. The rod forms an alignment and handling rod, being capable of acting, as it moves, on rings for simultaneously displacing the curved rod. Each ring is assembled with the ability to slide along the tubular element, and to be height-adjustable to compensate for dimensional deviations between the alignment and handling rod and the curved rod.

Abstract: A device (1) for use in the surgical treatment of a patient suffering from funnel chest characterised in that it comprises a plate adapted to be fitted underneath the skin of the patient, and further characterised in that, in use, said plate can be attached to the patient's sternum and the curvature, length and width of the plate being such that the plate extends on both sides of the sternum and on the outside of the patient's thorax and is supported by the ribs to hold up the sternum.

Abstract: A system and method for developing customized apparatus for use in one or more surgical procedures is disclosed. The system and method incorporates a patient's unique anatomical features or morphology. According to a preferred embodiment, the customized apparatus comprises a plurality of complementary surfaces. Thus, each apparatus may be matched and oriented around the patient's own anatomy, and may further provide any desired axial alignments or insertional trajectories. In an alternate embodiment, the apparatus may further be aligned and/or matched with at least one other apparatus used during the surgical procedure.

Abstract: A cover for use in protecting a resected surface of a long bone for use in joint arthroplasty is provided. The cover includes a generally planar portion having opposed generally parallel first and second surfaces defining a periphery extending from the first surface and the second surface. The cover also includes a lip extending from the first surface at the periphery of the planar portion in a direction not planar with the generally planar portion.

Abstract: A method of treating a patient in cardiac arrest (e.g., in fibrillation, electrochemical dissociation, or asystole), the method comprising delivering an agent for enhancement of cardiac function to the coronary arteries of the patient; and microperfusing the patient's cardiac tissue by electromagnetically stimulating the cardiac issue at an energy level below a threshold sufficient to defibrillate the heart.

Abstract: An automated external defibrillator (AED) (10) having a treatment decision processor (28) is described which estimates the probability of successful resuscitation made from an analysis of a patient parameter measured in the presence of CPR artifact. The invention may also adjust its analysis protocol and guidance outputs depending on a comparison of the estimate with a subsequent shock analysis. The invention also may use the trend of the measured patient parameter to adjust the CPR protocol either during a CPR pause or after the initial CPR pause. The AED (10) thus enables an improved rescue protocol.

Abstract: The implantable cardiac treatment system of the present invention is capable of choosing the most appropriate electrode vector to sense within a particular patient. In certain embodiments, the implantable cardiac treatment system determines the most appropriate electrode vector for continuous sensing based on which electrode vector results in the greatest signal amplitude, or some other useful metric such as signal-to-noise ratio (SNR). The electrode vector possessing the highest quality as measured using the metric is then set as the default electrode vector for sensing. Additionally, in certain embodiments of the present invention, a next alternative electrode vector is selected based on being generally orthogonal to the default electrode vector. In yet other embodiments of the present invention, the next alternative electrode vector is selected based on possessing the next highest quality metric after the default electrode vector.

Abstract: A system and method of enabling detection enhancements selected from a plurality of detection enhancements. In a system having a plurality of clinical rhythms, including a first clinical rhythm, where each of the detection enhancements is associated with the clinical rhythms, the first clinical rhythm is selected. The first clinical rhythm is associated with first and second detection enhancements. When the first clinical rhythm is selected, parameters of the first and second detection enhancements are set automatically. A determination is made as to whether changes are to be made to the parameters. If so, one or more of the parameters are modified under user control.

Abstract: An implantable medical device capable of sensing cardiac signals and delivering cardiac electrical stimulation therapies is enabled to detect a short circuit event. A signal is sensed by a sensing module coupled to electrodes. A controller detects a short circuit event in response to a slope of the sensed signal exceeding a short circuit threshold.

Abstract: An implantable medical device capable of sensing cardiac signals and delivering cardiac electrical stimulation therapies is enabled to detect a short circuit of a medical electrical lead. A physiological signal correlated to a motion of a patient is sensed via a physiological sensor. If a lead monitoring condition is met based on the physiological signal, a cardiac signal is acquired and analyzed to detect an abnormality. The short circuit of the medical electrical lead is detected in response to detecting the abnormality.

Abstract: A method of treating a patient in cardiac arrest (e.g., in fibrillation, electrochemical dissociation, or asystole), the method comprising delivering an agent for enhancement of cardiac function to the coronary arteries of the patient; and microperfusing the patient's cardiac tissue by electromagnetically stimulating the cardiac issue at an energy level below a threshold sufficient to defibrillate the heart.

Abstract: Techniques are provided for use with implantable devices equipped with programmable voltage multipliers (including voltage dividers.) Candidate pulse widths are determined for selected voltage multipliers and stimulation vectors. Each candidate pulse width corresponds to a lowest pulse energy sufficient to achieve capture within the tissues of the patient (subject to a safety margin) using the selected vector and using the corresponding voltage multiplier. As such, a candidate pulse width represents a preferred or optimal pulse width, at least insofar as energy consumption is concerned. However, depending upon the capabilities of the device, the candidate pulse width might not be achievable. Accordingly, for each programmable vector, the system determines a lowest “operable” voltage multiplier sufficient to generate a pulse at a candidate pulse width subject to the capabilities of the device.

Abstract: A rules engine acquires sensor data from sensors applied to the heart to determine the presence of a rapid heartbeat. The rules engine applies rules to the sensor data to determine whether to deliver an electrical waveform to a vagus nerve. The rules engine further determines whether an electrical waveform should be applied to the heart and, if so, the type of electrical waveform.

Abstract: A rules engine acquires sensor data from sensors applied to the heart and determines whether an electrical waveform should be applied to the heart and, if so, the type of electrical waveform. A multiphase cardiac stimulus generator generates waveforms in response to the rules engine. The electrical waveform is applied to one or more electrodes implanted in or on the heart.

Abstract: A rules engine acquires sensor data from sensors applied to the heart and determines whether an electrical waveform should be applied to the heart and, if so, the type of electrical waveform. A multi-phase cardiac stimulus generator generates waveforms in response to the rules engine from waveform data stored in a memory. The electrical waveform is applied to one or more electrodes implanted in or on the heart.

Abstract: A rules engine acquires sensor data from sensors applied to the heart and determines whether an electrical waveform should be applied to the heart and, if so, the type of electrical waveform. A multi-phase cardiac stimulus generator generates waveforms in response to the rules engine. The electrical waveform is applied to one or more electrodes implanted in or on the heart.