Abstract: A positioning and alignment instrument, and methods of use thereof, are provided for facilitating the alignment and insertion of a device, such as a guide wire, into bone. The instrument includes a handheld anchoring component and a rotatable guidance component. During use, the anchoring component is anchored into bone via anchoring protrusions, such that the position and orientation of the anchoring component is fixed relative to the bone. The guidance component, which is mechanically supported by the anchoring component, includes a device guide channel for receiving the device and guiding the device towards an insertion location adjacent to the distal end of the anchoring component. The guidance component is rotatable relative to the anchoring component about a rotation axis that is located adjacent to the distal end of the anchoring component, such that the insertion location remains adjacent to the distal end of the anchoring component under rotation.

Abstract: A medical positioning bracket is described that provides users with the ability to attach and secure multiple bone tunnel drill guides into a single working unit. Users can manipulate each drill guide independently and lock the drill guides at desired locations relative to one another to achieve precise bone tunnel angles and locations.

Abstract: The present invention provides devices and methods for percutaneously retrieving an embolized or malpositioned heart valve or foreign bodies from a patient's body. Several of these devices may include a catheter system with expandable and retractable baskets attached to a catheter and guidewire system. The guidewire may be inserted through the lumen of the embolized or malpositioned heart valve, capturing the valve in the baskets, and deploying a mechanism to crush the valve within the baskets. Then the crushed baskets and valve may be retrieved either from the body or to a safer location such as but not limited to the descending aorta. This system is advantageous because it does not require open surgery to retrieve the valve or embolized material.

Abstract: A surgical system includes an attaching device having an end effector disposed at the distal end thereof. The end effector includes a support member, a wrist pivot pivotably coupling the end effector to the attaching device, and first and second jaw members pivotably coupled to one another and the support member. A first cable is operably coupled to the wrist pivot and configured to articulate the end effector relative to the attaching device. Second and third cables are operably coupled to the jaw members and configured to pivot the jaw members relative to the support member. A first actuation of the second and third cables collectively pivots the first and second jaw members relative to the support member. A second actuation of the second and third cables pivots the first and second jaw members relative to one another and the support member between a spaced-apart position and an approximated position.

Abstract: The present disclosure relates to the field of medical devices generally and specifically, to endoscopic systems and methods for resection of malignant and pre-malignant lesions within the gastrointestinal (GI) tract. In particular, the present disclosure relates to systems and methods for delivering injectable compositions between tissue layers (e.g., between the muscularis and submucosa layers) to elevate and stabilize the lesion for fast and efficient resection.

Abstract: A tissue resecting device includes an end effector assembly including a proximal hub housing and a cutting member extending distally from the proximal hub housing, and a handpiece assembly. The handpiece assembly includes a handle housing, a drive casing extending distally from the handle housing, a drive rotor extending through and distally from the drive casing, and a seal ring disposed about the drive rotor. In an at-rest position, the seal ring is sealingly engaged between the drive casing and the drive rotor to inhibit fluid ingress into the annular space. Upon engagement of the end effector assembly with the handpiece assembly, a portion of the proximal hub housing is configured to urge the seal ring from the at-rest position to a displaced position wherein the seal ring is displaced from the drive rotor to reduce friction therebetween upon rotation of the drive rotor relative to the drive casing.

Abstract: A rotating cutting head catheter for passage through chronic total occlusions or other refractory atherosclerotic plaque from diseased arteries is disclosed. The catheter's rotating cutting head is designed to reside safely within an outer protective sheath when not in use. The outer protective sheath contains one or more helical grooves or slots, and the cutting head contains protruding blades or projections that fit into these helical grooves or slots. Application of torque to an inner catheter or wire attached to the cutting head applies spin to the cutting head, and the force of the sheath's helical grooves or slots against the cutting head's protruding blades or projections advances the cutting head outward from the protective sheath. Once extended, the cutting head may now rotate freely. The device may use a guidewire to direct the cutting head to the desired position.

Abstract: A surgical method utilizes a cutting blade having a thickness along a cutting edge of between about 0.0005 inch and about 0.020 inch and preferably between about 0.001 inch and 0.010 inch. The blade is moved in contact with relatively hardly tissues which are disposed adjacent to softer tissues at a surgical site in a patient. The blade is ultrasonically vibrated during the moving of the blades, whereby the hard tissue is cut with a modicum of damage being inflicted on the soft tissue.

Abstract: Systems and methods for separating an object such as a pacing lead from a patient tissue involve a flexible and torqueable shaft having an internal lumen sized to receive the object, and a hard separating mechanism for separating the object from the tissue. Typically the shaft and separating mechanism are advanced along or toward the object, and the separating mechanism is contacted with the tissue. The shaft is rotated to effect separation between the object and the tissue. The systems and methods are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A medical device is disclosed for cutting substances inside a body lumen, the medical device including a rotatable tubular drive shaft; an expandable cutting member arranged on distal side of the drive shaft; an axial moving shaft connected to a distal end of the drive shaft with the cutting member, the axial moving shaft configured to expand and contract the cutting member by axially moving of the axial moving shaft; a handle configured to retract the drive shaft and the axial moving shaft; and an operating member disposed on a different axis with respect to an axis of the axial moving shaft.

Abstract: A tissue-removing catheter for removing tissue in a body lumen includes an elongate body having an axis and proximal and distal end portions spaced apart from one another along the axis. The elongate body is sized and shaped to be received in the body lumen. A handle is mounted to the proximal end portion of the elongate body and operable to cause rotation of the elongate body. A tissue-removing element is mounted on the distal end portion of the elongate body. An inner liner is received within the elongate body and coupled to the handle at a proximal end of the inner liner. A sensor is arranged with respect to the elongate body and inner liner and is configured to detect wear of the inner liner caused by the elongate body contacting the inner liner during use.

Abstract: An obturator configured for use with a trocar includes a head and a distally extending shaft configured to be received within a working channel of a trocar. The obturator further includes a distal tip configured to puncture tissue, first and second needle entrance ports each arranged on at least one of the head or the shaft, and first and second needle exit ports arranged on the shaft. The first and second needle entrance ports communicate with the first and second needle exit ports, respectively, to define respective first and second suture paths extending obliquely to the central axis. Each of the first and second suture paths includes at least one sealing element. In some examples, the obturator further includes at least one deployable member coupled to the shaft and configured to project radially outwardly in a deployed position.

Abstract: A gas sealed access port is disclosed including a proximal housing having a central lumen providing gas sealed access to the surgical cavity, an inlet path for communicating with a source of pressurized gas, a tapered neck portion and an interior cavity accommodating an annular jet assembly for receiving pressurized gas from the inlet path to generate a gaseous seal within the tapered neck portion, and an elongated tubular body extending from the tapered neck portion in communication with the central lumen and including a flexible proximal body portion and a rigid distal body portion.

Abstract: Trocar components and methods of use are described, wherein the trocar components are configured to provide access to intraperitoneal space via the rectouterine pouch to surgical tools, which optionally include one or more surgical robot members. The surgical tools are optionally 5 mm or more in diameter. In some embodiments, a cannula part has a lumen sized to provide to a plurality of the surgical tools simultaneous transvaginal access to the intraperitoneal space via the rectouterine pouch. In some embodiments, an incision sized to receive a distal aperture of the cannula is created, optionally using one or two dilators. The dilators are sized to create (optionally starting from a puncture by a needle 2 mm in diameter or less) an oblong aperture. In some embodiments, the oblong aperture is at least twice as wide across a long diameter as across a short diameter.

Abstract: A spinal correction system includes a tensioning member and a fulcrum tensioner device including a housing defining a chamber having a biasing member therein and a camming pin operatively coupled with the biasing member. The tensioning member is configured to be received in the biasing member and looped around the camming pin, such that a first end of the tensioning member is oriented in a first direction and a second end of the tensioning member is oriented in a second direction. The camming pin is transitionable between an extended position in which the biasing member applies tension to the tensioning member and a retracted position in which the biasing member is compressed to inhibit application of tension to the tensioning member.

Abstract: A polyaxial bone screw assembly includes a threaded shank body having an integral upper portion receivable in an integral receiver, the receiver having an upper channel for receiving a longitudinal connecting member and a lower cavity cooperating with a lower opening. A down-loadable compression insert with tool receiving arm extensions, a down-loadable friction fit split retaining ring and an uploadable shank upper portion cooperate to provide for pop- or snap-on assembly of the shank with the receiver either prior to or after implantation of the shank into a vertebra. The shank and receiver once assembled cannot be disassembled.

Abstract: Connectors are disclosed herein that can be used to attach a rod to a bone anchor assembly that is already occupied by a separate rod. Various ways of attaching the connector to the bone anchor assembly are disclosed, including arrangements in which the connector is locked to the bone anchor, arrangements in which the connector is constrained in one or more degrees of freedom relative to the bone anchor, arrangements in which the connector is adjustable in one or more degrees of freedom relative to the bone anchor, and arrangements that include a spherical articulation joint. In some embodiments, attachment of the connector to a bone anchor can be aided with the use of a positioner. The geometry of the connector can be selected to minimize the offset between a first rod received in the bone anchor assembly and a second rod received in the connector, for example using an angled or curved rod recess and/or a fastener, or set screw, that is offset from the center of the rod or angled relative to the bone anchor.

Abstract: Surgical instruments, methods, and systems are provided for securing spinal fixation elements to bone. For example, a spinal fixation system is provided that has a receiver with proximal and distal ends. The proximal end of the receiver is configured to receive various fixation members, such as spinal rods and set screws, therein. The distal end of the receiver has a hook member that is operably coupled thereto and has an opening that is configured to receive bone therein. The hook member is configured to be secured to bone without penetrating the bone.

Abstract: Anterior cervical plates for spinal surgery employing anchor backout prevention devices, and related systems and methods are disclosed. A spinal column includes vertebrae in an articulating structure. Medical intervention may involve limiting the relative motion between vertebrae by fusing at least first and second vertebrae together with osteosynthesis systems. The systems include a plate attached to anterior surfaces of the first and second vertebrae with anchors extending through passageways in the plate. By including one or more anchor backout prevention devices to the plate, movements causing the anchors to disengage from the vertebrae may be avoided. The devices may include a positioning guide, and locking magnets. The implementation of a combination of these devices into the plate may provide greater robustness against failure than any of the devices individually. In this manner, the useful life of the plate within a patient may be lengthened.

Abstract: A surgical implant device configured to adjust in planar orientation or angular orientation or both to correspond to the structure of the lamina to be spanned at the site of a cut of the laminoplasty surgery. The device includes a base having slots extending adjacent thereto, and an extension having a head configured to be adjustably positionable within the slots.

Abstract: Rod link reducer assemblies, systems, and methods thereof. The rod link reducer assembly provides a manipulator rod having a first end, a second end, and an elongate body extending along a body axis between the first end and the second end. A post extends outwardly from the rod. A rod manipulating joint comprise an elongate joint rod extending along a joint rod axis, a first coupling clamp disposed along the joint rod, the first coupling clamp releasably connectable to the post, and a second coupling clamp disposed along the joint rod adjacent to and rotatable about the joint rod relative to the first coupling clamp. The second coupling clamp is releasably connectable to a shaft. A biasing member is adapted to bias the second clamp against the first clamp.

Abstract: In one general aspect, an orthopaedic fixation device includes an inner core and shaft formed of a multi-layered, fiber-reinforced composite. A sensing element is embedded within the multi-layered, fiber-reinforced composite.

Abstract: Various intramedullary implants, instruments, and methods are disclosed herein. In an example, a compression instrument is used to provide internal compression of bones adjoining a joint or bones spanning a fracture to cause compression of the joint or fracture.

Abstract: A compression force magnifier comprising: an engaging surface for attaching to a bone plate; a ramped component above the engaging surface, the ramped component having a bottom surface adjacent the engaging surface and an angled upper surface; and a hole extending through the ramped component and the engaging surface.

Abstract: A cervical plate and one or more locking assemblies that help prevent screw backout without impinging on therapeutically valuable settling of the screws. In some cases, the locking assembly is configured to be permanently attached to the plate, to be securely but efficiently locked, to be readily unlocked for revision surgery, and/or to reduce the possibility of operator error in installation by providing simplified visible and tactile indicia of the locked and unlocked positions.

Abstract: A bone plate sized and shaped for fixation to a metacarpal includes a head extending from a first end to a second end and having first and second fixation element holes extending therethrough along first and second fixation element hole axes, wherein the first hole axis diverges from the second hole axis on a bone facing side of the plate, the head having a first notch on the first end centered on the central longitudinal axis, the first notch formed as a indentation on an outer wall of the bone plate sized and shaped to accommodate a collateral ligament when the plate is fixed to a metacarpal in a desired position and a shaft extending from the second end of the head to a third end along the central longitudinal axis, the shaft including an elongated fixation element hole elongated in a direction parallel to the central longitudinal axis.

Abstract: An implant and guide are described, together with methods for configuring the same. The implant and guide are for maxillofacial osteosynthesis and may be provided as a kit. Three-dimensional models of the pre- and post-operative anatomy are used to define attachment points. These attachment points are used to define a structure for the implant and the guide.

Abstract: A fixation device is disclosed for the fixation of proximal humerus fractures includes an implantable humerus plate having a proximal portion adapted to be positioned at a head and medial calcar of the humerus, a distal portion adapted to be positioned along a shaft of the humerus, and a plurality of calcar openings provided through the proximal portion adapted to receive calcar fasteners that extend into the medial calcar. The calcar fasteners are grouped into a rafted configuration and the tips of each fastener are positioned into the calcar region so that torsional forces bearing upon the calcar regions are distributed into the rafted fastener support, thereby avoiding varus collapse of the humerus head after fixation of the fracture.

Abstract: A surgical fixation assembly includes a shank having an outer surface. The outer surface of the shank includes a threaded portion. The surgical fixation assembly includes a first cupped washer supported on the shank, a sleeve, and a nut threadably engaged with the threaded portion of the shank. The nut is positioned to slide the sleeve axially along the shank to deform the first cupped washer and enable the first cupped washer to penetrate osseous tissue for securing the shank to osseous tissue.

Abstract: Reinforced biocomposite materials. According to at least some embodiments, medical implants are provided that incorporate novel structures, alignments, orientations and forms comprised of such reinforced bioabsorbable materials, as well as methods of treatment thereof.

Abstract: A cryosurgery system for application of medical-grade liquid nitrogen to a treatment area via a small, low pressure, open tipped catheter. The system includes a console, including a touch panel computer, a cryogen module, a suction module and an electronics module, and a disposable spray kit. Features include optional low cryogen flow setting to reduce the cryogen flow rate by 50%, improved cryogen flow consistency reducing pressure pulses and peaks, an integrated suction pump for improved consistency and self-checks, specified vent tube areas and corresponding maximum expected pressures during cryospray procedure; optional pressure sensing capability to monitor pressure during a treatment, and novel catheter designs of multilayer and flexible construction providing a variety of spray patterns.

Abstract: A treatment device is disclosed, which includes a dissecting section main body which is configured to dissect tissue in a living body when inserted into the living body along a blood vessel, and which has a slit permitting a branch vessel branched from the blood vessel to enter into the slit, a stanching section which is disposed at the slit and which presses and cauterizes the branch vessel introduced into the slit, and a cutting section which is disposed at the slit and which cuts the cauterized branch vessel.

Abstract: A grasping treatment unit includes a first jaw, and a second jaw openable and closable relative to the first jaw. In the first jaw, a heating wire continues without branching from a first extending end to a second extending end, and generates heat over an entire length from the first extending end to the second extending end when an electric current flows therethrough. A heating portion is lower in calorific value per unit area in a distal portion than in a proximal portion in the first jaw in a state where the heat is generated from the heating wire.

Abstract: An electrosurgical generator includes: a power supply configured to output a DC waveform; an inverter coupled to the power supply, the inverter including a plurality of switching elements; and a controller coupled to the inverter and configured to generate a switching angle waveform including a plurality of switching pulses. The controller is further configured to at least one of select or calculate the plurality of switching pulses to activate the plurality of switching elements to generate a radio frequency waveform based on the DC waveform and to minimize harmonics of the radio frequency waveform.

Abstract: Apparatus, consisting of a power supply having a first electrical connection to a relatively high voltage source and connectable to ablation circuitry in a catheter via a second electrical connection. There are rechargeable first and second subsidiary power sources in the power supply. The apparatus also has a control unit, and a first switch alternately connecting the ablation circuitry to the first and second subsidiary power sources responsively to control signals from the control unit. The apparatus also has a second switch alternately connecting one of the first and second subsidiary power sources to the high voltage source for recharging thereof responsively to the control signals while the one of the first and second subsidiary power sources is disconnected from the ablation circuitry and another of the first and second subsidiary power sources is connected to the ablation circuitry by the first switch.

Abstract: The invention generally relates to a tissue ablation system including an ablation device to be delivered to a target site and achieve both resection and coagulation of tissue. The ablation device can be used during an electrosurgical resection procedure to both resect tissue and further selectively coagulate surrounding tissue in the resection site so as to prevent or stop fluid accumulation (e.g., blood from vessel(s)) as a result of the resection of tissue.

Abstract: Methods and devices are described for the design and manufacturing of a knife with a robust double bevel cutting edge profile for use in surgical procedures. The double bevel cutting edge profile may be defined by a combination of a cutting edge angle and a radius of the cutting edge tip. In some embodiments, the cutting edge profile may be defined by a combination of a web thickness profile and a radius of the cutting edge tip. Numerical ranges are identified for each of the various geometric parameters which may define a cutting edge that provides sufficient knife sharpness over many cutting repetitions. In some embodiments a medical device, which implements a knife with a cutting edge, for use in surgical procedures is described.

Abstract: An electrosurgical system includes a resectoscope and a generator. The resectoscope includes a fixed electrode, a movable electrode movable relative to the fixed electrode, and first and second switches actuated in first and second positions of the movable electrode, respectively. The generator is configured to supply energy to the fixed electrode and/or the movable electrode when the movable electrode is moving from the first position to the second position and to inhibit the supply of energy when the movable electrode is moving from the second position to the first position. The generator is configured to determine a direction of movement of the movable electrode based upon signals received from the first and second switches.

Abstract: Described here are devices and methods for forming a fistula between two vessels. In some instances, the fistula may be formed between a proximal ulnar artery and a deep ulnar vein. The fistula may be formed using an electrode, and may be formed with a first catheter placed in a first blood vessel and a second catheter placed in a second blood vessel. In some instances, access to the proximal ulnar artery may be achieved through a brachial artery, and access to the deep ulnar vein may be achieved through a brachial vein.

Abstract: Systems, device and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa tissue.

Abstract: Ablation systems and methods of the present disclosure are directed toward delivering pulsed radiofrequency (RF) energy to target tissue. The pulsations of the RF energy, combined with cooling at a surface of the target tissue, can advantageously promote local heat transfer in the target tissue to form lesions having dimensions larger than those that can be safely formed in tissue using non-pulsed RF energy under similar conditions.

Abstract: Devices and methods for treating tissue with microwave energy used in applications such as destroying a soft tissue by microwave ablation and/or creating point, line, area or volumetric lesions. Various embodiments of flexible, low-profile devices are also disclosed where such device can be inserted non-invasively or minimally invasively near or into the target tissue such as cardiac tissue. The devices disclosed herein comprise antennas wherein the field profile generated by an antenna is tailored and optimized for a particular clinical application. The antennas use unique properties of microwaves such as interaction of a microwave field with one or more conductive or non-conductive shaping elements to shape or redistribute the microwave field.

Abstract: In one embodiment, the disclosure is directed to an integrated apparatus for delivering energy to a tissue. The integrated apparatus included a housing having a distal end and a tubular structure located within the housing forming a first annulus between the tubular structure and the housing. The tubular structure is configured to accept an energy delivery component and is configured to form a second annulus between the tubular structure and the energy delivery component. The first annulus and the second annulus are configured to communicate with each other proximate to the distal end of the housing.

Abstract: A customized patient-specific combined template and implant for spinal fixation and method for use.

Abstract: The present invention relates to a device (2) for determining an optimal placement of a pedicle screw (4), comprising a processing unit (14), wherein the processing unit is configured to receive a model data set representing a model surface (22) of a human vertebra model (18) and a pedicle screw model (30) being optimally placed in a span of a pedicle section (28) of the model surface, wherein the processing unit is configured to receive 5 image data representing a surface image (26) of at least one human vertebra (6), GO and wherein the processing unit is configured to adapt the model data set for each of a number of the at least one human vertebra, such that an adapted model data set representing a correspondingly adapted model surface (36), which fits to the surface image of the respective human vertebra, is provided for each of the number of the at least one human vertebra, wherein each of the 10 adapted model data sets also represents a correspondingly adapted pedicle screw model (38).

Abstract: The invention relates to a method of determining the sagittal rotation of a patient's pelvis based on a standard anterior posterior X-ray-image with known image parameters and a calibration of the image, for example by using at least one King-Mark calibration object. The angle of the pelvic rotation is determined between a pelvic plane which is orthogonal to the midsagittal plane of the pelvis, and the image plane of the X-ray-image. Assuming the patient's position shown on the X-ray-image represents a standard neutral position, the X-ray-image plane can be used as a functional reference plane for further calculations, for example during hip-replacement surgery. The present invention further relates to a corresponding computer program and system.

Abstract: A simulated method and system for surgical instrument based on tomography are provided. The method includes obtaining a biological stereoscopic image and inputting a parameter set of an implant to be implanted, denoting a target position and an initial position in the biological stereoscopic image, estimating a dimensional coordinate of a contact area of the implant and a living organism when the implant has been implanted into the living organism based on the parameter set, the target position and the initial position in the biological stereoscopic image, and obtaining a physiological data set by re-sampling corresponding to the dimensional coordinate of the implant in the living organism for evaluating the effect after the implant has been implanted into the living organism. Surgeons may evaluate the effect after implantation of implant into the living organism by using the simulated method, enhancing the overall quality and result of the surgery.

Abstract: A system for aiding surgery on a patient is described including a display device and a storage device that stores an image of at least a portion of the anatomy of the patient, including one or more surgical navigation markers positioned on the patient, for display on the display device. An analyser is adapted to receive positional data of a probe based on positioning of the probe relative to the one or more markers on the patient. Based on the positional data, the analyser outputs correctional data to adjust an alignment of the image on the display device to match locations of said one or more markers.

Abstract: An interventional procedure can be performed less invasively with live 3D holographic guidance and navigation. Advantageously, the 3D holographic guidance and navigation overcomes the limitations of conventional displays of medical images on standard 2D flat panel screens. The live 3D holographic guidance can utilize a 3D holographic visualization that is derived from complementary imaging modalities (e.g., ultrasound and computed tomography) to provide a complete holographic view of a portion of the patient's body to enable navigation of a tracked interventional instrument/device.

Abstract: A method of using a robotic guidance system for performing surgery on a spine is provided. The method includes utilizing a computerized tomographic scan image of a location on a spinal column of a patient, such that the computerized tomographic scan image is connected to a computer and visible on a monitor connected to the computer. The method also includes attaching a coupling component to the spinal column of the patient, coupling a marker to the coupling component, and imaging, with a fluoroscope, the view of the spinal column of the patient, wherein the fluoroscope image is transmitted to the computer and visible on the monitor and the at marker is clearly visible in the fluoroscope image.