Abstract: A ligature delivery device includes a control member, an elongated shaft, and an end effector attached to the distal end of the elongated shaft. An activation mechanism provides an user-operable connection between the control member and the end effector. In several embodiments, the end effector includes a reverse grasping mechanism. Several embodiments of ligature devices are adapted to be deployed endoscopically and/or translumenally using the reverse-grasping delivery device.

Abstract: In particular embodiments, a septal orifice closure device for closing a septal defect can include a frame structure comprising a coil having a first loop turn, a second loop turn and a third loop turn. A biodegradable member can be attached to the second loop turn, for example. The second loop turn can be sandwiched between the first and second loop turns. The biodegradable member can be replaced by the body with scar tissue formation and endothelial cells such that only the frame member remains in the body after a period of time. The lumen can be configured to allow a medical device to be inserted through the device at the location of the previous orifice at a later time as other therapeutic interventions are warranted.

Abstract: One aspect of the present invention relates to catheters that can be placed in or around bodily conduits to occlude or widen a biological lumen without imparting significant trauma to the lumen. In certain embodiments, the invention particularly relates to the use of a polymer composition which can be made to gel upon insertion into said balloon or skirt. In certain embodiments, the inflating viscous polymer composition is a liquid at room temperature and a gel at mammalian physiological temperature. In certain embodiments, the inflating viscous polymer composition comprises an optionally purified inverse thermosensitive polymer.

Abstract: A disposable tourniquet comprising a buckle and a band attached at one end to the buckle, the buckle comprising a base into which the band can be laid and a laterally hinged clamp closure that can be closed over the band to grip it in the buckle and a hinged closure securing tab.

Abstract: A hemostatic device includes a flexible band adapted to be wrapped around a patient's limb at a site on the limb where bleeding is to be stopped, a portion for securing the band in a wrapped state to the limb, a curved plate which is made of a material more rigid than the band and at least a portion of which is curved toward the inner peripheral side thereof, a main balloon which is provided on the inner peripheral side of the curved plate and which inflates when a fluid is introduced therein, and a pressing member which is provided between the curved plate and the main balloon so that at least a portion thereof overlaps with the balloon and which is adapted for pressing against the balloon. The device provides an excellent hemostatic effect and prevents numbness and poor circulation in areas peripheral to the site of attachment.

Abstract: A hemostasis tool has a flexible bandage body that is used by being wound around a puncture site, a balloon that is arranged in the bandage body, and that is dilated by injecting a fluid so as to compress the puncture site in a dilated state, and a detection unit that detects a strength level of a pressing force of the balloon pressing the puncture site, based on discoloration or deformation. In this manner, it is possible to detect the pressing force of the balloon pressing the puncture site. Accordingly, the balloon can properly compress the puncture site.

Abstract: A cutting guide for performing a bone osteotomy procedure is disclosed. The cutting guide includes a first arm having a first cutting guide surface formed therein, a second arm having a second cutting guide surface formed therein pivotably connected to the first arm and a distractor operatively connected to the first arm. The cutting guide is adapted to be affixed to the bone such that the first cutting guide surface is open to the second cutting guide surface. The first arm and second arm are rotatable with respect to each other such that manipulation of the distractor creates a force between the first arm and the second arm causing rotation of the first arm and second arm relative to each other. A method for using the cutting guide in a bone osteotomy procedure is also disclosed.

Abstract: Punch instruments (5) are provided in some embodiments for cutting tissue in a resected proximal tibia. Such instruments can include an elongate handle (10) and a cutting head (20) disposed at the distal end of the elongate handle (10). The cutting head (20) can include a first annular blade member (25) with a first leading cutting edge (29) that extends generally transversely to a longitudinal axis of the elongate handle (10). The cutting head (20) can include a second annular blade member (26) that is situated inwardly of the first annular blade member (25) and which includes a second leading cutting edge (30) that extends generally transversely to the longitudinal axis of the elongate handle (10).

Abstract: A cutting burr that includes a pair of axially spaced diamond-shaped portions designed to be keyed into a spindle of a locking mechanism of a high speed surgical drilling instrument and adapted to fit into a single pawl thereof to lock said cutting burr in place so as to prevent axial movement thereof and provide concentric rotation of said cutting burr without any wobbling. The orientation of both portions may be identical with respect to a center plan and diamond shape in the portion at the proximal end of the shank of the cutting tool may be larger than the intermediately located diamond shape of the other portion. The apexes of the facets of the six-sided diamond shape may be disposed below the surface of the shank of the cutting burr.

Abstract: A patient-specific alignment guide includes a patient-specific portion and a guiding element having a through opening. The patient-specific portion has a patient-specific surface preoperatively configured to mate as a negative of a portion of an iliac crest of a pelvis of a specific patient and mate to the iliac crest only in one position. The guiding element has a preoperatively configured orientation and location relative to the patient-specific portion for preparing a bore in the bone of the patient to direct a bone screw at the preoperatively configured orientation and location for sacroiliac fixation.

Abstract: Systems, methods and devices are disclosed for aligning surgical jigs, tools and implants in a patient.

Abstract: Provided herein are expandable endoscopic devices. In accordance with certain aspects of an embodiment of the invention, an endoscopic expandable device is disclosed that comprises an expandable jaw at the distal tip, a control wire connected to the jaw, a sheath enclosing the control wire, and a handle connected to the sheath or wire having an actuating trigger. The expandable jaw is configured to allow its delivery in a retracted configuration to a target site within a patient's body through the working channel of an endoscope, after which the jaw may reconfigure to an expanded configuration that is larger than the retracted configuration. This allows the expandable jaw to be easily delivered to the target site while allowing an operable jaw size that is larger than would be allowed if limited to size of the working channel.

Abstract: An implement for increasing tissue vascularization includes a handle with a receiving post and a retainer movable between a first position and a second position, and a cutting wheel disposed on the receiving post. The cutting wheel includes at least one cutting element disposed on an outer periphery of the cutting wheel. In the first position, the handle permits the cutting wheel to be mounted on the receiving post. In the second position, the cutting wheel is held in place with respect to the receiving post yet freely rotatable with respect to the receiving post.

Abstract: A surgical instrument includes a housing having a barrel defining an axis and a fixed handle extending from the barrel. The barrel includes at least one elongated indentation and the fixed handle defines a waist. A shaft extends from the barrel along the axis and couple to an end effector at a distal end thereof. A movable handle coupled to the housing is configured to manipulate the end effector. The movable handle includes a proximal leg, a distal tail, an arcuate segment defining a finger-retaining area, and a proximal foot. A deployable member is slidably disposed within the shaft. A trigger coupled to the housing is configured to deploy the deployable member. The trigger defines a saddle portion. The housing, movable handle, and trigger are configured to facilitate operable grasping by a hand of a user in at least first and second different grasping configurations.

Abstract: An end effector assembly for a surgical instrument includes first and second jaw members, each including a jaw frame, spacer, electrically-conductive plate, and outer housing. The jaw frame includes at least one proximal flange and a distal jaw support extending distally therefrom. The spacer defines a body and a wing disposed on either side of the body. The body defines a channel configured to receive the distal jaw support while each wing defines a slot. The plate defines a tissue-contacting portion and first and second legs extending perpendicularly from the tissue-contacting portion. The tissue-contacting portion is configured to sit atop the body of the spacer. Each of the legs is configured for receipt within the slot defined within one of the wings. The outer housing at least partially surrounds the distal jaw support, spacer, and legs and is configured to retain these components in position relative to one another.

Abstract: Thrombectomy systems and devices and methods of using the same. In an exemplary embodiment of a thrombectomy system of the present disclosure, the thrombectomy system comprises a thrombectomy sheath, comprising a circumferential outer wall reinforced with a reinforcement, configured as an elongated tube having a lumen therethrough; and a sonovisible element positioned at or near a distal end of the circumferential outer wall; wherein the thrombectomy sheath is sized and shaped to be at least partially positioned within a vein proximal to a thrombus or other item within the vein and further configured to expand to contact the vein to secure the thrombectomy sheath within the vein; and wherein the lumen is sized and shaped to receive a device selected from the group consisting of a balloon catheter and a snare having a loop.

Abstract: The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Abstract: Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Ultrasound catheter devices generally include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. Improved features of ultrasound catheters include catheter bodies and ultrasound transmission members with increasing distal flexibility, guidewire tubes allowing contact between a guidewire and an ultrasound transmission member, distal heads with improved guidewire lumens, and torquable proximal housings for enhancing disruption of blood vessel occlusions.

Abstract: The present disclosure provides systems and methods for cutting mucosal tissue. In particular, the present disclosure provides an endoscopic hood with an integrated wire for single-step tissue cutting. The endoscopic hood is particularly useful for performing repeated cutting, for example EMR resections, without the need for assistance by a nurse or medical technician.

Abstract: Methods and devices for assessing, and treating patients having sympathetically mediated disease, involving augmented peripheral chemoreflex and heightened sympathetic tone by reducing chemosensor input to the nervous system via carotid body ablation.

Abstract: An ultrasonic surgical tool comprises a substantially planar blade body having a pair of opposed lateral surfaces and a cutting edge. A shank integral on a distal side with the blade body is provided at a proximal side with a connector for operatively linking the blade to a source of ultrasonic mechanical vibrations. The blade body is provided in at least one of the lateral surfaces with a shallow recess which is nearly coextensive with that lateral surface. The blade body has a raised rim surrounding and defining the recess, the rim being narrow on the three sides between the recess and the cutting edge.

Abstract: An end effector includes a first portion having a first specific acoustic impedance value, and a second portion having a second specific acoustic impedance value less than the first specific acoustic impedance value. The first portion may include a proximal end segment and a distal end segment. The proximal end segment and the distal end segment are composed of a first material. The second portion may include an insert segment composed of a second material. The insert segment is located between the proximal end segment and the distal end segment along the longitudinal axis of the end effector. The insert segment functions to bridge or fill a nodal energy gap defined by the end effector.

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A wire for use with a vascular treatment device may have a proximal end, a distal end, and a main shaft extending therebetween. The distal end may have a distal free end and a first segment. The first segment may extend from the main shaft and may be biased to a first included angle that is defined between the main shaft and the first segment and less than 180 degrees.

Abstract: A pair of cooperating catheters are used together to provide rapid access to the Left heart for diagnostic or therapeutic interventions. The initial entry point for the catheter pair is the groin. The pair of catheters can be used to carry out an electrographic determination of the location of the Fossa Ovalis on the septum. Features on the Catheter system permit quick and reliable confirmation of the catheter location via echo or x-rays. Once across the septum the inner catheter is removed from the outer catheter and a standard intervention may be carried out through the lumen of the outer catheter.

Abstract: A surgical access device for facilitating access through an incision to a surgical site in a patient's body has a pliable membrane which is configured to engage and expand the incision. The pliable membrane includes a base layer, a permeable membrane attached to the base layer, and a fluid channel disposed between the layers. The fluid channel is fluidly coupled to a fluid source. The fluid is delivered to the surgical site via the permeable membrane. The surgical access device may also have a locking mechanism for holding the device in a desired configuration.

Abstract: A cannula assembly including a housing, a rotatable member, a first plurality of membranes, and a second plurality of membranes is disclosed. The housing may include a distal end defining a distal opening, wherein the distal end is configured to couple to a cannula tube aligned with the distal opening, and a proximal end defining a proximal opening. The rotatable member may be positioned within the housing and may define a passage in fluid communication with the distal opening, a first opening in fluid communication with the passage, and a second opening in fluid communication with the passage. The first plurality of membranes may be arranged as a stack at the first opening, wherein each of the first plurality of membranes defines an aperture. The second plurality of membranes may be arranged as a stack at the second opening, wherein each of the second plurality of membranes defines an aperture.

Abstract: Instruments, systems and methods are provided for efficient loading, indexing and replacement of cartridges for storing, for example, hair grafts. In addition, an improved urging mechanism for expelling hair grafts from a receptacle of a storage cartridge is provided, as well as a method of its operation. Furthermore, cartridges with a plurality of receptacles comprising slots for loading hair grafts are disclosed.

Abstract: The present disclosure relates to a needle including a wall structure, a cutting edge and a blunt contour. The needle advantageously can be used to deliver a sensor (such as a glucose or other analyte sensor) through an outer skin layer and into a sensor depth in a less invasive way than prior art needles. The size of the cutting edge is balanced against a portion of the distal wall structure that has blunt contours. Thus, the needle is capable of cutting the more durable outer skin layer (first phase) and then progressively stretching open the cut for further advancement into the subcutaneous layer (second phase). When the needle is sufficiently advanced, it is retracted leaving the sensor in a desired position. Early testing has shown a reduction of “dip and recover” from glucose sensors delivered using the needle.

Abstract: The present disclosure relates to a needle including a wall structure, a cutting edge and a blunt contour. The needle advantageously can be used to deliver a sensor (such as a glucose or other analyte sensor) through an outer skin layer and into a sensor depth in a less invasive way than prior art needles. The size of the cutting edge is balanced against a portion of the distal wall structure that has blunt contours. Thus, the needle is capable of cutting the more durable outer skin layer (first phase) and then progressively stretching open the cut for further advancement into the subcutaneous layer (second phase). When the needle is sufficiently advanced, it is retracted leaving the sensor in a desired position. Early testing has shown a reduction of “dip and recover” from glucose sensors delivered using the needle.

Abstract: An obstetrical instrument includes an elongated handle and a fetal head support portion coupled with a distal end of the elongated handle.

Abstract: A locking member for a bone fixation device can include a locking body that defines an outer surface, an opposed bone contacting surface, and a slot that extends from the bone contacting surface to the outer surface. The locking member can further include at least one locking tooth that extends into the slot and a biasing member that extends into the slot and defines an abutment surface that faces the at least one locking tooth. The slot can be configured to receive a toothed member along an insertion direction and the biasing member can be configured to bias the toothed member toward the at least one locking tooth such that at least one tooth of the toothed member engages the at least one locking tooth of the locking member so as to prevent the toothed member from translating through the slot along a direction that is opposite the insertion direction.

Abstract: A percutaneous access device includes an inner tube and an outer tube disposed about at least a portion of the inner tube. The outer tube may be sized to span from a skin incision in a patient to a site proximate the spine of the patient. The distal end of the outer tube may be adapted to releasably engage a bone anchor. The inner tube may be adjustable relative to the outer tube between a first position and a second position in which the distal end of the inner tube contacts the bone anchor. A bone anchor assembly includes a bone anchor having a distal bone engaging portion and a receiving member having a recess for receiving a spinal fixation element. The proximal end of the receiving member may have an arcuate groove formed on an exterior surface thereof to facilitate connection of an instrument to the receiving member.

Abstract: The present invention relates generally to a surgical device for the correction of deformities of the spinal column and finds particular, although not exclusive, utility in devices which are surgically implantable. Presently known implantable surgical devices are unable to provide for the progressive correction of spinal deformities assisted by active movements of the human body without fusion of the involved part of the spinal column. The present surgical device comprises a spinal column straightening means for permitting the relative rotation of two substantially adjacent vertebrae about a common axis substantially only in opposite rotational directions.

Abstract: A closed-head polyaxial screw for use in spinal instrumentation for spinal fusion, treatment of deformity, or the like. Polyaxial screws may have a two-part design, with the screw fitting into an aperture in the closed head. One or more clamps may secure the bone screw in the aperture. A closed-head polyaxial screw having a one part design is also disclosed. In addition, a one-part monaxial screw is described.

Abstract: A spinal correction apparatus comprises a body. A ratchet is disposed with the body. A longitudinal element is connected to the ratchet. A force is applied to at least a portion of the apparatus that causes dynamic incremental movement of the longitudinal element relative to the body in at least one direction. Methods of use are disclosed.

Abstract: A bone fixation system with variable z-axis translation is provided. The bone fixation system includes an outer tulip coupled to a bone fastener. An inner tulip, which provides a seat for an elongate fixation rod, is located inside the outer tulip. The inner tulip together with a seated rod is permitted to translate along the z-axis in an unlocked position. Also in the unlocked position, the bone fastener is free to angulate relative to the outer tulip. The bone fixation system includes a locked position in which the z-axis position of the inner tulip and rod relative to the outer tulip is fixed. Also in the locked position, the bone fastener is locked with respect to the outer tulip. The system may be adjusted between the locked and unlocked positions by way of a set screw or independently by rotation of the inner tulip relative to the outer tulip.

Abstract: A bone anchor (100) for attaching a rod (108) to a bone has an anchor member (106) for attachment to the bone and an anchor head (104) having a U-shaped opening for receiving the rod. The bone anchor also includes a locking cap (102) that has a main body (900) and a set screw (1000). Advantageously, in one embodiment the locking cap preferably is designed such that a single tool can be used to lock the locking cap in place on the anchor body preferably with a 90° turn and preferably then drive the set screw to clamp the rod. The locking cap also preferably non-threadingly engages the anchor body. The anchor body preferably has an inclined surface on its top surface which elastically deflects extending tabs on the main body to secure the locking cap to the anchor body. A method of implantation and assembly of the bone anchor are also described.

Abstract: Spine stabilization systems and integrated rods are disclosed. One spine stabilization system disclosed has at least four bone anchors and a stabilization member attached to the bone anchors. The stabilization member has first and second elongate portions interconnected by a connector portion. The first and second elongate members extend longitudinally and generally parallel to a central longitudinal axis and connector portion extends transverse to the central longitudinal axis from a first lateral end to a second lateral end. The connector portion is integrally connected to the first and second elongate portions such that there is no relative movement between the lateral ends and the respective elongate portion to which each end is attached.

Abstract: The present application provides a tool for minimally invasive surgical procedures. The tool includes a first and second portion where each portion has an outer blade and an inner blade that is slidable along the outer blade. A removable connector connects the first and second portions. When removed, the first and second portions are separated by a gap extending the length of the tool.

Abstract: Minimally invasive methods and devices for introducing a spinal fixation element into a surgical site in a patient's spinal column are provided. In general, the method involves advancing a spinal fixation element in a first, lengthwise orientation along a pathway extending from a minimally invasive percutaneous incision to a spinal anchor site. As the spinal fixation element approaches the spinal anchor site, the fixation element can be manipulated to extend in a second orientation, which is preferably substantially transverse to the first orientation, to position the fixation element in relation to one or more spinal anchors.

Abstract: A device includes a housing and a locking assembly disposed within a spaced defined by the housing. The housing defines a hole that extends through the housing. The locking assembly is configured to allow the device to slide along an elongate orthopedic device in a first direction and to hinder the device from sliding along an elongate orthopedic device in a second direction that is opposite the first direction.

Abstract: An intramedullary implant has opposite ends inserted into bores in abutting phalanges for correcting hammer toe and for similar arthrodesis procedures. A rear end of the implant may be threaded and is received in a bore in the proximal phalanx. A front end has an asymmetric pointed shape with longitudinally and/or angularly spaced rear-facing gripping flukes. The pointed front end is received in the middle phalanx. The asymmetric pointed shape is self-aligning, enabling entry to begin without first longitudinally aligning the bones. The rear end when screwed into place can be rotated to select the orientation of the asymmetric pointed shape. The pointed front end is inserted and pushed to bring the phalanges into abutment where the implant holds them against retraction or rotational displacement.

Abstract: A distal radius plate according to the invention is ergonomically formed to be more easily centered on the radius bone. The distal radius plate has two main portions: an elongated portion that attaches to the body of the radius and a distal radius portion that attaches to the lower most, wider portion of the radius bone. Because of its ergonomic shape the distal radius plate is fast and easy to center on the radius and install. In another embodiment, the distal radius plate may include a metal support that is partially or entirely covered with a plastic to eliminate or reduce detailed machining of the metal, which reduces part cost and manufacturing time.

Abstract: Embodiments of the invention provide a bone screw device including a bone screw with a temporary encasement. In some embodiments, the temporary encasement comprises a biocompatible material that may be an osteoinductive, a hemostatic and or a bacteriocide. Some embodiments include a temporary encasement including a therapeutic. In some embodiments, the temporary encasement comprises a wax. In some embodiments, the screw head is substantially U-shaped. In some embodiments, the screw includes an extension tip extending from the screw shaft. Some embodiments of the invention include a system for percutaneous implantation of a bone screw including a screwdriver shaft rotatably coupled to a screw that includes a temporary encasement. In some embodiments, the screw shaft can be at least partially rotated by the screwdriver shaft. Some further embodiments further include a retractable sleeve at least partially surrounding the screwdriver shaft and the bone screw.

Abstract: A valve controller includes a housing, and a lever extending from the housing. The lever includes a protrusion rigidly attached to the lever, and the lever is biased to an initial position. A switch has an open and a closed position. A linkage is pivotally connected to the switch, and the linkage includes a centrally disposed slot configured to receive the protrusion such that movement of the switch controls movement of the linkage and the lever such that moving the switch to the closed position closes a valve controlled by the lever regardless of a position of the lever.

Abstract: An apparatus for extracting a medical implant from bone includes: a housing; a coupler carried by the housing and configured to be mechanically connected to a medical implant; and a forcing mechanism carried by the housing and operable to apply a cyclic excitation force with a specified amplitude, frequency, and vector to the coupler. Methods are described for using the apparatus to remove and/or implant medical implants.

Abstract: A non-linear ablation device includes two opposing surfaces, which are associated with two overlying and separate compartments. A first compartment of the two overlying and separate compartments is configured to emit or resorb energy. A second compartment of the two overlying and separate compartments is configured to either resorb or emit energy to oppose a direction of energy transfer of the first compartment. Other embodiments of the non-linear ablation device are further disclosed.

Abstract: Methods and cryogenic devices for assessing, and treating patients having sympathetically mediated disease, involving augmented peripheral chemoreflex and heightened sympathetic tone by reducing chemosensor input to the nervous system via carotid body ablation. Some methods include advancing a cryo-ablation catheter into a patient's vasculature and ablating tissue within a carotid septum.

Abstract: A cryogenic medical device for delivery of subcooled liquid cryogen to various configurations of cryoprobes is designed for the treatment of damaged, diseased, cancerous or other unwanted tissues. The device is a closed or semi-closed system in which the liquid cryogen is contained in both the supply and return stages. The device is capable of generating cryogen to a supercritical state and may be utilized in any rapid cooling systems. As designed, the device comprises a number of parts including a vacuum insulated outer dewar, submersible cryogen pump, baffled linear heat exchanger, multiple pressurization cartridges, a return chamber, and a series of valves to control the flow of the liquid cryogen. The cryogenic medical device promotes the subcooling to any external cryogenic instrument.