Abstract: A method for treating a vertebral bone comprises providing a gaseous substance and providing a flowable and settable bone filling material. The method further comprises introducing the gaseous substance into the bone filling material to form a porous bone augmentation material and inserting a material delivery device into the vertebral bone. The method further comprises injecting the porous bone augmentation material from the material delivery device and into the vertebral bone.

Abstract: Disclosed are vertebroplasty methods that include cauterizing an inner cavity of a vertebra of a mammal, such as a human, and injecting bone cement into the vertebra. Systems and kits for performing such methods are also disclosed.

Abstract: A surgical device and method for injecting cement in a bone cavity includes an elongated, hollow body to be inserted partially into the cavity. The body has an inner lumen with a distal opening to expel cement therefrom. An entry plug for the cement is connected to a cement pressurized supply. The entry plug is in fluid communication with the lumen to deliver cement through the entry plug, wherein the entry plug is movably mounted on the hollow body.

Abstract: A bone graft delivery system includes a bone graft injector and an access portal. The access portal may include a handle having a first arm pivotably connected to, and biased away from, a second arm. A ratchet including a pawl may extend from the second arm. A delivery tube may be configured to mate with the first arm and be configured to store a bone graft material therein. A plunger including a shaft and a plunger tip at the distal end thereof may be configured to move through the delivery tube. At least a portion of the shaft may include teeth, the pawl of the ratchet being configured to iteratively contact the teeth. A user may hold the access portal with a first hand and the bone graft injector with a second hand, iteratively squeezing the handle to iteratively eject amounts of bone graft material into a patient.

Abstract: A device for dispensing biomaterial includes a handle configured to receive a syringe, the syringe including a biomaterial and a threaded plunger, and an engagement pin retained within the handle and slidable between a first position and a second position. The engagement pin is configured to engage the threaded plunger in the first position, the engagement pin is further configured to disengage from the threaded plunger in the second position.

Abstract: Described herein are applicators for delivery of a viscous material to a bone surface and methods of use. The applicator includes an elongate handle portion and a tip coupled to a distal location of the handle portion and formed of an elastomeric material configured to conform to the bone surface. The tip includes a bend a distance away from the distal location, a contact surface distal to the bend and including one or more surface features configured to adhere to the viscous material, and a front end having a conic curvature. The bend is between about 20 degrees to about 40 degrees from a longitudinal axis of the tip.

Abstract: The present invention relates in certain embodiments to medical devices for treating vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the flow of bone cement into the interior of a vertebra and the application of forces causes by the cement flow. An exemplary system utilizes Rf energy in combination a conductive bone cement for selectively polymerizing the inflow plume to increase the viscosity of the cement. In one aspect of the invention, the system utilizes a controller to control bone cement flow parameters to either allow or disallow cement interdigitation into cancellous bone. A method of the invention includes pulsing the flows of bone cement wherein high acceleration of the flow pulses can apply expansion forces across the surface of the cement plume to reduce a vertebral fracture.

Abstract: An instrument for performing a medical procedure includes a drive shafts a holding clutch, a drive clutch, and an actuator. The holding clutch only allows advancement of the drive shaft, while the drive clutch transfers an advancement force from the actuator to the drive shaft. The dual clutch system allows a lever to be used as the actuator so that a user can generate large actuation forces manually (and optionally remotely) without significant physical effort. This capability can beneficially improve the usability and effectiveness of percutaneous surgical systems, such as those for vertebroplasty or kyphoplasty.

Abstract: An intervertebral prosthesis or disk prosthesis comprising a front side, a rear side, an upper side which can be placed on the base plate of vertebral body, a lower side which can be placed on the base plate of a vertebral body, a right side, a left side, a cavity which can receive a fluid hydraulic osteocementum, an opening in the cavity and several outlets out from the cavity. The total of the transversal surfaces of the outlets SV on the front side, the total of the transversal surfaces of the outlets SH on the rear side, the total of the transversal surfaces of the outlets SR on the right side and the total of the transversal surfaces of the outlets on the left side satisfy the following conditions: SL>SR or SR>SL or SH>SV or SV>SH.

Abstract: The present invention relates to the medical field, in particular relates to the practice of percutaneous vertebroplasty where a pair of syringes in the distal extreme of a lengthened hydraulic device, are united by a camera of intermediate connection of larger diameter (pressure exerting body) or modified inverted syringe tube with a bolster, a hydraulic connecting tube of flexible material that transmits the pressure of the smaller diameter manual or impulsion syringe in the proximal extreme of the device toward the intermediate cylindrical larger diameter camera (pressure exerting body), this camera is in an inverted position with regard to the first syringe (fluid control), this intermediate camera has a moving piston longitudinal to the axis of the cylinder that is controlled with the first syringe (manual) and in cooperation with the atmospheric pressure.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, a device for delivering a bone filler material comprising: a housing having a throughbore; a plunger comprising a shaft having external threads, wherein the plunger is configured for advancement through the throughbore of the housing; and a threaded receiving member configured to releasably engage the plunger. Methods for removing an instrument from a vertebral body comprising applying ultrasonic energy to the instrument, wherein a distal end of the instrument is disposed in a cavity in the vertebral body, wherein the cavity contains a filler material; and removing the instrument from the vertebral body.

Abstract: The present invention relates to medically useful devices and methods for introducing flowable compositions into mammalian body cavities. More specifically, the devices and methods of the present invention are useful for introducing restorative compositions into intraosseous cavities. Such devices and methods are particularly useful in percutaneous vertebroplasty or kyphoplasty procedures for the controlled introduction of bone cement into a vertebral cavity.

Abstract: This invention relates generally to an instrumentation and implant system providing minimally invasive vertebral augmentation. The apparatus including an expandable membrane sized and configured to be located within a cavity in a patient's bone and having an interior volume for receiving bone filler material; a delivery cannula in communication with the membrane for providing bone filler material to the membrane; and an evacuation cannula in fluid communication with the membrane for receiving a portion of the provided bone filler material from the membrane.

Abstract: The present invention relates to a medical instrument which comprises a tool portion with a first tool element for engagement with a corresponding second tool element on an implant, and which further comprises a bone cement container arranged or formed on or in the instrument.

Abstract: In at least one embodiment of the present invention, a device for mixing and dispensing a bone cement mixture is provided. The device comprises a first chamber and a second chamber. The first chamber is for containing a first bone cement component. The second chamber is for containing a second bone cement component. A valve is in fluid communication with the first and second chambers. A first and a second plunger are respectively within the first and second chambers and are configured to actuate within their respective chambers. When the valve is in a first position actuating the first plunger advances the first bone cement component into the second chamber to form the bone cement mixture.

Abstract: A distance interbody device for introducing a biomaterial to a vertebral body includes a shaped body and a dispense mechanism operable to dispense biomaterial. The shaped body includes a top side, a bottom side, and a lateral wall forming a peripheral wall that extends between the top and bottom sides. The shaped body is provided with at least one through channel and at least one anchoring element. The through channel includes an internal reservoir for the biomaterial. The through channel passes through the anchoring element to at least one outlet opening located in the at least one anchoring element.

Abstract: A syringe that has a barrel with curvature is provided. The curvature enables a greater volume of bone graft materials to be housed than in a straight syringe without increasing the absolute distance from the handle of the plunger to dispensing end of the syringe. Additionally by maintaining a constant diameter, the barrel permits bone graft material to be dispersed with reduced likelihood of clogging.

Abstract: A hardenable two part acrylic composition is described for the treatment of human or animal bone is described. The composition comprises a storage stable liquid first part and a storage stable liquid second part which react with each other upon mixing to form a cement which hardens. The composition further comprises an acrylic monomer component and an initiator component in an amount effective to polymerize the monomer component. The monomer component and the initiator component are generally located in separate parts of the two part composition so that the monomer component is storage stable. The liquid first part comprises emulsion polymerized acrylic polymer particles in a liquid carrier. A method of producing a hardenable two part acrylic composition is also described. The composition is particularly useful in a syringe or caulking gun having at least two barrels.

Abstract: A stylet-guided balloon vertebroplasty system, as well as methods for bone augmentation using same are provided. In certain embodiments, a pre-curved stylet with an overlying delivery tube may be used to target an approximately centered target site within a bone structure, facilitating direction thereto of an expandable member useful for creating a cavity that may receive curable material to restore bone height and/or to reinforce the bone structure.

Abstract: A system and method for shaping an anatomical component having an existing shape and a desired reconstructed shape include an applicator for depositing material on the anatomical component and a controller in communication with the applicator, the controller controlling the deposition of material by the applicator based on a relationship between the applicator and the existing shape of the anatomical component to create the desired reconstructed shape.

Abstract: A method of treating a vertebra, comprising: (a) accessing an interior of a vertebra; and (b) introducing a sufficient amount of artificial biocompatible material which does not set to a hardened condition in storage, into said bone, with sufficient force to move apart fractured portions of said bone.

Abstract: An irrigation resistant bone repair composition including a biocompatible or bioactive bone repair material and a mixture of non-random poly(oxyalkylene) block copolymers is described. Also, methods for treating a bone having a bone gap or a bone defect with the composition including a biocompatible or bioactive bone repair material and a mixture of non-random poly(oxyalkylene) block copolymers are also provided. Also, kits including the irrigation resistant bone repair composition including a biocompatible or bioactive bone repair material and a mixture of non-random poly(oxyalkylene) block copolymers are described.

Abstract: A device for dispensing biomaterial includes a handle configured to receive a syringe, the syringe including a biomaterial and a threaded plunger, and an engagement pin retained within the handle and slidable between a first position and a second position. The engagement pin is configured to engage the threaded plunger in the first position, the engagement pin is further configured to disengage from the threaded plunger in the second position.

Abstract: A laterally deflectable asymmetric implant for implanting into a body may comprise a deflectable piece having distal and proximal ends and assuming a straightened insertion state. The backbone may abut or interconnect with said deflectable piece at the distal end of the deflectable piece. In a fully deflected state the implant may define an asymmetric shape, e.g. a D-shaped loop, defining an at least partially enclosed volume. The deflectable piece may comprise a sequence of segments interconnected at effective hinges. Longitudinal pressure applied to the proximal end of the deflectable piece (or applied to the backbone in an opposite direction) may cause relative longitudinal movement between the backbone and the proximal end of the deflectable piece and may generate outward horizontal movement of the deflectable piece away from the backbone. In one embodiment, the implant is implanted using lateral access into an anterior zone of a vertebra and deployed posteriorly.

Abstract: A device for delivering material to multiple surgical target locations includes a pressure reservoir selectably coupled to two or more outlets. Coupling the pressure reservoir to a given one of the outlets and pressurizing the pressure reservoir causes flowable material (e.g., bone filler material) to be dispensed from that outlet. A diverter for selectably coupling the pressure reservoir one of the outlets can be configured to trigger a pressure release valve for the pressure reservoir upon switching, thereby preventing unexpected or uncontrolled material delivery from the new outlet in response to sudden high pressure exposure.

Abstract: Methods and instruments for treating an osteoporotic vertebral body or for treating a vertebral compression fracture. An exemplary method includes introducing an open knit structure together with a bone cement into a bone wherein the knit structure extends substantially throughout the interior of the cement volume. In one aspect of the invention, the bone cement volumes cures with the filament structure reinforcing the cement. In another aspect of the invention, the open knit structure is configured to direct flows of bone cement to apply forces for reducing a vertebral compression fracture. In another aspect of the invention, the system provides bone cement flows that extend through the knit structure thus allowing the cement to fully interdigitate with the cancellous bone.

Abstract: The device for injecting a high viscosity material into a cannula includes a body having a material-moving member disposed therewithin which separates the body into a first cavity adapted to receive an incompressible fluid and a second cavity adapted to receive a high viscosity material. A pressure applicator, including a housing having incompressible fluid, is remote from but connected to the body by an extension line providing fluid flow between a fluid outlet of the pressure applicator and the first cavity. First and second check valves within the housing control the flow through the housing. The power piston generates negative pressure within the housing to draw the incompressible fluid in when the piston is extended, and generates positive pressure within the housing, forcing the incompressible fluid out through the second check valve and the fluid outlet and into the first cavity of the non-compliant body, when the piston is depressed.

Abstract: A method for treating a vertebral bone comprises providing a gaseous substance and providing a flowable and settable bone filling material. The method further comprises introducing the gaseous substance into the bone filling material to form a porous bone augmentation material and inserting a material delivery device into the vertebral bone. The method further comprises injecting the porous bone augmentation material from the material delivery device and into the vertebral bone.

Abstract: A bone cement injection device whereby bone cement is inserted through the skin and into bone, and can easily be separated during outflow of the bone cement into the blood vessels and spinal canal and curing. An outer insertion member has an outer needle tube having one end that is sharpened to be inserted through the skin and into bone and a partially closed part where the cross-sectional area of the internal space is reduced. A main hand grip is integrally formed on the other end of the outer needle tube and has a fastening part able to be fastened to a bone cement supply. An inner insertion member includes an inner needle rod for insertion into the other end part of the outer needle tube which opens through the main hand grip, and an auxiliary hand grip which is integrally formed on the inner needle rod.

Abstract: A bone cement applicator for applying a bone cement to a bone surface is provided. The hone cement applicator includes a bone cement receiver, a first housing and a second housing. The bone cement receiver has a first opening to be connected with a bone cement supplier supplying the bone cement. The first housing is connected with the bone cement receiver. The second housing is connected with the first housing. A cavity is formed between the first housing and the second housing. The cavity is in fluid communication with the first opening. The second housing includes a contact surface and a plurality of holes. The contact surface is in contact with the bone surface. The holes are located on the contact surface, in which the bone cement reaches the bone surface after sequentially flowing through the first opening, the cavity, and the holes.

Abstract: Compositions of, methods of making, and methods of using alkaline earth phosphate bone cements are disclosed. A bone cement composition includes a powder comprising a basic source of calcium, magnesium, or strontium, a setting solution comprising H3PO4 and a buffer, and a biocompatible polymer that is incorporated into the setting solution. The powder is mixed with the setting solution to form a bone cement paste that either (a) sets into a hardened mass, or (b) is irradiated with electromagnetic radiation to form dry powders, the dry powders then being mixed with a second setting solution to form a radiation-assisted bone cement paste that sets into a hardened mass.

Abstract: For dispensing a material with thermoplastic properties in a flowable state at an operation site in a human or animal patient, a device is used, which includes the material having thermoplastic properties in a solid state and is equipped for bringing the material into a flowable state at a distal device end positioned at the site where dispensing is desired and for driving the flowable material from this distal device end. The device comprises a rotation drive, a consumable element and a dispenser element, wherein one of the two elements is coupled to the rotation drive and wherein the consumable element comprises the material to be dispensed. The two elements are arranged with parallel longitudinal axes and the dispenser element comprises a distal end piece with a proximal face against which a distal face of the consumable element is held and advanced during dispensing.

Abstract: The present invention relates to a device and method for delivery of bone graft material to any portion of a patient which requires bone graft material. The device according to various embodiments delivers bone graft to a bone graft receiving area. The bone graft delivery device is formed such that a hollow tube and plunger selectively and controllably place bone graft material in or adjacent to the bone graft receiving area.

Abstract: The invention relates to a process for preparing cements used for reparative or reconstructive bone surgery, in particular for fixing prostheses, for bone repair and for vertebroplasty, and obtained from liquid single-phase formulations. It also relates to the cements prepared from these single-phase formulations and to a device for injecting them.

Abstract: A device for delivering material to multiple surgical target locations includes a pressure reservoir selectably coupled to two or more outlets. Coupling the pressure reservoir to a given one of the outlets and pressurizing the pressure reservoir causes flowable material (e.g., bone filler material) to be dispensed from that outlet. A diverter for selectably coupling the pressure reservoir one of the outlets can be configured to trigger a pressure release valve for the pressure reservoir upon switching, thereby preventing unexpected or uncontrolled material delivery from the new outlet in response to sudden high pressure exposure.

Abstract: The invention relates to a device for the injection of a bone cement. The invention comprises a container provided with one end including an outlet and a second end that receives a piston. The piston is moved by means of an injection screw that projects from the container body and engages with gripping means comprising injection screw rotation means that can self-lock depending on the pressure exerted inside the container body, said rotation means comprising a handle which is provided with a passage that receives the injection screw and which is hinged thereto by means of a pair of male/female disks. One disk is known as the drive disk and moves integrally with the rotation movements of the handle, while the other disk is known as the driven disk, said drive disk coming into contact with the driven disk in response to a compressive force exerted on the distal part of the injection screw.

Abstract: An apparatus and method to implant a seal in a skull base defect. The seal is implanted using apparatus with deployable elements which pass up the nasal cavity into the area of the sphenoid sinus where they deploy and expand into useful conformations. A disk is inserted through the skull base defect into an interior side of the skull at the base defect, with a stalk extending through the skull base defect. The stalk is held outward from the skull base defect, holding the disk against the interior side of the skull while a conical mold is filled with bone cement. Once the cement has cured, the apparatus is removed, leaving the insert in the skull with the stalk surrounded by a cone of bone cement, creating a water tight seal in said skull base defect.

Abstract: A system for injecting an incompressible low viscosity fluid into a bone cement reservoir adapted to be engaged with a cannula through which a high viscosity bone cement is transferred from the bone cement reservoir to a bone element is provided. The system comprises a control handle having a cylindrical body, a grip portion at an outer end of the cylindrical body and a central thumb-actuated plunger of a power piston, the grip portion being configured for receiving at least two fingers a user such as to permit actuation of the control handle by the single hand of the user, the cylindrical body including the power piston and a low viscosity fluid reservoir concentrically disposed relative to each other, the low viscosity fluid reservoir containing the incompressible low viscosity fluid and the power piston extending longitudinally through a center of the low viscosity fluid reservoir.

Abstract: A curable material delivery cannula device and method are disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end and a deflectable distal segment, and a distal orifice(s) fluidly connected to the lumen. When distally extended from the guide cannula, the deflectable segment assumes a curved shape, which may be used to create a void in the bone for receiving curable material. During use, curable material, such as bone cement, is delivered from the distal orifice(s).

Abstract: Systems and methods for treating bone, such as vertebral compression fractures are disclosed. A method includes controllably applying energy to a bone cement volume outside of a patient's body to selectively accelerate the polymerization rate of the bone fill material volume prior to introduction into a bone. The method further includes sequentially introducing a plurality of cement carrying structures with the accelerated polymerization rate bone cement volume into the bone. A system for use in the method includes at least one elongated cement-carrying structure sized to carry a bone cement volume therein and an energy source operatively coupleable to the cement-carrying structure. The energy source applies energy to the bone cement volume to selectively accelerate a polymerization rate thereof. An elongated injector insertable into the bone has a passageway that removably receives the elongated cement-carrying structure to allow delivery of the accelerated polymerization rate bone cement into the bone.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. Methods for treating a bone comprising: creating a cavity in the bone; inflating a containment jacket in the cavity; inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket; introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon; removing the balloon from the containment jacket; and introducing a second filler material into the first portion of the containment jacket.

Abstract: A device for injecting a high viscosity material into a cannula, comprising a container being non-compliant and having an outlet adapted to communicate with the cannula for transferring the high viscosity material thereto, a pressure applicator in fluid communication with the container, the pressure applicator defining a fluid flow path through which an incompressible fluid is displaceable, and a material-moving member interrupting the fluid flow path and defining an incompressible fluid receiving portion on one side thereof in communication with the fluid flow path and a high viscosity material receiving portion in communication with the outlet of the container on an opposed side. The material-moving member being displaceable by a pressure of the incompressible fluid acting thereagainst to force the high viscosity material out of the high viscosity material receiving portion of the container and into the cannula.

Abstract: An apparatus and method for dispensing bone cement includes a cartridge for containing the bone cement. The apparatus also includes a plunger insertable into the cartridge. An impedance sensor is coupled to the plunger and configured to produce an output signal indicative of an impedance of bone cement contained in the cartridge. The apparatus may also include a processing circuit configured to determine an impedance value of bone cement contained within the cartridge based on the sensor signal. The processing circuit may activate a visual indicator based on the impedance value to indicate that the dough time, the end-of-work time, and/or setting-time of bone cement contained in the cartridge has been reached.

Abstract: A device for mixing, dispensing and applying a paste, such as bone cement, has a housing (1), a cylinder (4) for receiving the paste, and a piston (13) associated with a piston rod (7). A mixing paddle (12) is provided with ridges (23) for engagement with grooves (24) on the piston (13). By this engagement, the paddle-piston assembly (12-13) can be rotated after removal of a safety pin (9) and interconnected by a jamming mechanism (25). After this interconnection, the paddle-piston assembly (12-13) is used to push the paste inside the cylinder (4) and out thereof for dispensing. A low-friction piston rod locking mechanism (14) is provides as well.

Abstract: A method for treating a vertebral bone comprises providing a bone filling material and mixing the bone filling material in a vessel to form a bone augmentation material. The method further comprises pressurizing the vessel with a pressurization source to retain a plurality of voids within the bone augmentation material. The method further includes inserting a material delivery device into the vertebral bone and injecting the bone augmentation material with the retained plurality of voids from the material delivery device and into the vertebral bone.

Abstract: A guide apparatus having a body having a central axis defined therethrough and a first channel and a second channel formed therethrough, a handle coupled to the body, the handle having a locking mechanism configured to prevent movement of the body relative to the handle in a first direction along the central axis of the body, and an arm coupled to the handle, the arm configured to engage at least a portion of a bone.

Abstract: A set of instruments configured to deliver a therapy to a bone can include a cannulated syringe. The cannulated syringe can extend along a longitudinal axis between a proximal and a distal end. The cannulated syringe can have an inner tube and an outer tube that are interconnected at the distal end as a single fixed unit. A first cannulation can be formed along the longitudinal axis of the cannulated syringe within the inner tube and a second cannulation can be formed within an annular space between the inner and outer tubes. The outer tube can define an opening through a sidewall thereof. The cannulated syringe can be closed from fluid communication between the inner and outer tubes.

Abstract: A cement delivery needle apparatus (20) and a method of flowing a bone cement through a vertebroplasty needle apparatus are provided. The cement delivery needle apparatus (20) includes a sheath (24) and a handle (26). The sheath (24) has an inlet (44) to receive a bone cement and an outlet (40) for expressing the cement into a vertebral body. The handle (26) extends from the sheath (24) and includes a vibration assembly (70) for agitating the cement. The method includes providing a bone cement source to the needle. The method further includes providing a vibration assembly associated with a handle of the needle, agitating the cement with the vibration assembly and injecting the cement through the sheath.

Abstract: A bone cement is provided that includes a solid component and a liquid component. The solid component and liquid component are mixed together to form the bone cement. After completion of the solid and liquid component mixing, the bone cement has an initial viscosity effective for manual application or manual injection onto or into a targeted anatomical location, e.g., bone, and the cement has stable viscosity range that over both time and temperature is effective for uniformly filling the targeted anatomical location, for example an osteoporotic bone or a fractured vertebral body, with minimal to no leakage of the cement from the targeted anatomical location. Additionally, both the initial viscosity and the stable viscosity of the bone cement are within a range that renders the bone cement effective for injection with a manually operated syringe or multiple syringes.

Abstract: A bone screw comprises an interior channel and at least one opening extending from the interior channel to an exterior of the screw shaft. A head is connected to the screw shaft. A fluid delivery probe comprises an interior channel. The fluid delivery probe is locked to the head so that the fluid delivery probe does not separate from the head under extremely high pressures when a fluid is pumped through the fluid delivery probe and into the screw shaft. Also, a leak-free seal is formed between the fluid delivery probe and the screw shaft so that the leak-free seal does not leak under extremely high pressures when a fluid is pumped through the fluid delivery probe and into the screw shaft.