Abstract: A device for delivering a material to an orthopedic target site is disclosed. The device can be used to deliver bone cement to an intra-vertebral site. The device can have a pusher rod within a tube. The tube can be loaded with the bone cement distal to the pusher rod. The pusher rod can have varying rigidity along the length of the pusher rod. The tube and pusher rod can navigate tortuous pathways from a percutaneous or transcutaneous insertion en route to the target site or to improve extracorporeal ergonomics. Methods for using the same are also disclosed.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. The distal end may be provided with one or two or more cavity creation elements, such as a bevel or diamond tip or inflatable balloons. A cavity creation element may include one or more filament layers. Systems are also disclosed, including the steerable and curvable injection needle, introducer and stylet. The system can also include various exit ports that can be configured with clog-resistant features. Methods are also disclosed.

Abstract: A system and method is provided for distracting opposite surfaces from the interior of a bone, such as a vertebral body. A working channel cannula provides a working channel through which an inserter and an injection cannula can simultaneously pass. The inserter transports a plurality of wafers into the interior of the bone to form a load-bearing stack bearing against the opposite surfaces. The injection cannula is used to inject a fluent material into and/or around the stack. In certain embodiments, the fluent material is a load-bearing or hardenable material, such as bone cement. In other embodiments, the fluent material can be a BMP, HAP, or other osteo-inductive, osteo-conductive, or pharmaceutical compositions. A syringe containing the fluent material is engaged to the injection cannula and is operable to inject the fluent material into the vertebral body under controlled pressure.

Abstract: A biocompatible, resorbable collagen membrane containment member for a bone regenerative material, and a method of using such a containment member to regenerate a bone defect by surgically accessing the bone defect; disposing the containment member adjacent the bone defect, and thereafter injecting a bone regenerative material into the containment member.

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: An isolation device for repairing a cartilage defect including a syringe and a barrier device. The barrier device is connected to the syringe. The barrier device is sized to surround and contain the cartilage defect, and is configured to provide a seal around the cartilage defect for application of a positive pressure and a negative pressure from the device. The device is configured to provide a localized therapy to the cartilage defect.

Abstract: Systems and methods for injecting bone filler into a vertebra, wherein a spinous process and/or lamina can be strengthened by injecting the bone filler into the spinous process and/or lamina. An insertion device including a needle can be positioned proximal to the junction between the spinous process and the lamina of the vertebra when inserting the bone filler. Various embodiments of the needle and needle guide devices can be used to facilitate the process.

Abstract: The present invention relates to novel bone substitute compositions and methods of use. It further encompasses the use of these novel bone substitute compositions for bone augmentation and the treatment of disease conditions. The invention also contemplates a kit including bone substitute compositions and a percutaneous delivery device.

Abstract: A percutaneous path is established into a selected bone, e.g., a vertebral body, having an interior volume occupied, at least in part, by cancellous bone. A first bone filling material is conveyed through the percutaneous path into a region of the cancellous bone. A second bone filling material is conveyed through the percutaneous path into the region. The second bone filling material is different than the first bone filling material.

Abstract: An application device for bone substitute material is disclosed. A cylinder contains a piston rod having an elastically deformable piston. The cylinder is closed via an attachment, through which a wetting liquid phase can be inserted via an injection opening. After a period of time, the wetted bone substitute material is compressed, with excess liquid phase being pressed out through drainage openings. Thereafter, the attachment can be removed and if applicable discharging takes place through a curved discharge nozzle, with the piston being able to adapt itself to the curvature with the benefit of total emptying of the device.

Abstract: A bone filler material delivery system comprising a longitudinal channel, wherein said channel incorporates a perforated segment at least partially along, at or substantially near its distal end, and wherein said channel is sealed at its distal end so the filler material may be delivered only by the lumen and through the perforated segment peripheral wall/s. Optionally, said system comprising an expandable-collapsible permeable bag capable of being inserted into a bone while in collapsed configuration and then to expand within the bone when filled with bone voids filler. The mesh structure is designed to allow such permeable bag to expand to a predetermined size or shape under certain pressures, and further allows exudation of said bone void filler through its walls. One satisfactory result is achieved by extracting the permeable bag out of treated body, thus promoting a flow of the bone void filler through its pores into the cancellous bone and/or cavity in the bone.

Abstract: A bone cement delivery method that includes inserting a portion of a bone cement delivery device into a femoral neck of a femur of a patient, and injecting bone cement paste into the femoral neck of the patient via the bone cement delivery system.

Abstract: A curable material delivery cannula device is disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end, a deflectable segment forming a pre-set curve, a lumen, and side orifice(s) adjacent, and proximally spaced from, the distal end and fluidly connected to the lumen. When inserted within a guide cannula, the deflectable segment straightens. When distally extended from the guide cannula, the deflectable segment reverts to the curved shape. The distal end has a blunt tip for non-traumatic interface with bodily material. During use, curable material, such as bone cement, is delivered from the side orifice(s) in a radial direction relative to the lumen. The device may be used to create voids for receiving curable material, and may include spacers configured to control location and/or orientation of the voids.

Abstract: Systems and methods for delivering bone cement into a bone can include a handle body defining a flow path, a thermal emitter in the handle body to apply energy to bone cement passing through the flow path, a source of bone cement and an injection cannula. The cannula can be in communication with the flow path such that inserting the cannula into a bone can allow a flow of bone cement therethrough to an opening at a distal end of the cannula. Other systems and methods for delivering bone cement into a bone can include an injector body with a handle portion, and a cannula, a bone cement container, a low pressure drive mechanism configured to effect a flow of bone cement from said container to the injector body and a high pressure drive mechanism configured to effect a flow of bone cement through the injector body into the bone.

Abstract: A method for treating arthritis of a joint includes identifying a bone lesion in a bone adjacent to the joint; and implanting in the bone a reinforcing member in or adjacent to the bone lesion. A kit for conducting the method includes: (a) at least one reinforcing member having a proximal face adapted to face the joint, a distal face adapted to face away from the joint, and a wedge-shaped edge adapted to pierce bone, wherein the at least one reinforcing member is planar and sterile; and (b) a container adapted to maintain the at least one reinforcing member sterile. Another kit includes: (a) a sterile fluid; (b) a syringe for injecting the fluid into a bone; (c) a curing agent adapted to cure the fluid to polymerize and/or cross-link; and (d) a container adapted to maintain the sterility of contents of the container.

Abstract: The present teachings provide one or more surgical instruments for repairing damaged tissue, such as in the case of a vertebral compression fracture. The present teachings can provide a bone cement system. The system can include a housing, which can define at least a throughbore that can extend from a proximal end to a distal end of the housing. The system can also include a dispenser housing received in the throughbore of the housing that is adapted to receive a bone cement. The system can include a plunger, which can be releasably coupled to the proximal end of the housing and received into the dispenser housing so that movement of the plunger can dispense the bone cement. The system can also include a pressure release system, which can be coupled to the housing and can be movable to release pressure within the dispenser housing without moving the plunger.

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: Bone material delivery devices and methods of using the devices are provided. The bone material delivery devices and methods comprise thermochromic material disposed on the exterior of the syringe, the thermochromic material configured to provide an indication of temperature, viscosity, and/or age of bone replacement material in the interior of the syringe. In some embodiments, a time indicating label is disposed on the exterior of the syringe, the time indicating label comprising a label substrate having a first surface comprising an acid-base indicator and a second surface comprising an activator, wherein when the first surface is brought into contact with the second surface or when the second surface is brought into contact with the first surface, at least a portion of the label changes color indicating elapsed time. In some embodiments, the devices and methods allow the practitioner to know the dough time, working time, and setting time of the bone replacement material when it is in the syringe.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. A containment assembly comprising a containment jacket adapted to be deployed inside bone; and a dividing wall that separates the interior of the containment jacket into a proximal region and a distal region, the dividing wall having an opening for providing access to the distal region from the proximal region.

Abstract: The present invention relates to two technical programs of a remote-controlled injection device for injecting born materials into centrum, which include a injector with a piston and a precession handspike or slip handspike, a rotational handle or driving handle is fixed at one end of the precession handspike or slip handspike, there is a base in the two programs, and a injector holder is fixed at one end of the base, the said injector is fastened in the injector holder with injector fixed knob by bolt, the said rotational handle or driving handle connects to the handle joint, and there is a fast disassembled connection between handle joint and dynamic joint, the dynamic joint connects with the stepper motor or linear stepper motor, and the projecting shaft of stepper motor or linear stepper motor is coaxial with precession handspike or slip handspike.

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: The invention relates to a dental implant method using a tissue punch, sinus lift drill (SLD) and hydraulic effect which places a bone graft and embed a dental implant at a maxillary sinus area where there is not sufficient bone to embed a dental implant. The method includes: removing mucoperiosteum having a size of an dental implant to be implanted at a alveolar crest area using a tissue punch, drilling a maxillary sinus floor easily and safely without causing damage to a maxillary sinus membrane by inserting a sinus lift drill which has a protruding member that is elastically installed in the body so as to protrude from and retract in the longitudinal direction of the body, elevating a maxillary sinus membrane by the hydraulic effect (injecting graft adjacent to the drilled maxillary sinus floor); and installing the implant in an inside portion of the drilled maxillary sinus floor.

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 in certain embodiments to medical devices for treating osteoplasty procedures such as vertebral compression fractures. More particularly, embodiments of the invention relate to instruments and methods for controllably restoring vertebral body height by controlling the geometry of fill material introduced into cancellous bone. An exemplary system utilizes Rf energy in combination a conductive bone fill material for polymerizing the surface of the inflow plume to control the geometry of the fill material and the application of force caused by inflows of fill material. In another embodiment, method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of a selected portion of the bone filler to control the direction of flow of the fill material within the bone.

Abstract: A remotely-activated injection device for use in vertebroplasty is provided to inject a flourescent probe material into a patient. The injection device includes a pump defining an injection chamber having an exit opening; an actuator; and a cable having a first end coupled to the actuator, and a second end remotely engaging the pump. The actuator remotely controls the pump by responsive movement of the cable to thereby cause injection of a flourescent probe material from the injection chamber of the pump through the exit opening to the patient.

Abstract: The disclosure relates in certain embodiments to medical devices, systems and methods for use in osteoplasty procedures, such as vertebral compression fractures. One system for delivering a bone fill material to a bone includes an elongated introducer configured for insertion into a bone and having a channel sized to allow a flow of bone fill material therethrough. The introducer has at least one outlet opening in communication with the channel for delivering the bone fill material into the bone. A thermal energy emitter is coupled to the introducer and configured to apply thermal energy to the bone fill material flowing through the introducer. A sensor and a computer controller can be used to measure data about the bone fill material and to control certain aspects of the flow of bone fill material. A hydraulic pressure source may also be operatively coupled to the introducer and configured to apply a force on the bone fill material to provide a pressurized flow of bone fill material through the introducer.

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: 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: An instrument for performing a medical procedure includes a nozzle sized to fit through a cannula, and a plunger sized to be advanced through the nozzle and urge material through a distal tip of the nozzle. The plunger includes an interior lumen and a distal tip having a side port, such that after material delivery from the nozzle, the distal tip of the plunger can be extended beyond the distal tip of the nozzle, and additional material delivery can be performed via the side port of the plunger. This dual action material delivery capability can beneficially enhance material placement at the target location, and can also enable delivery of different materials to the target location without having to exchange delivery tools.

Abstract: An apparatus for delivering bone cement into a vertebra includes a cannula and a mix and delivery device pivotally coupled to the cannula. The mix and deliver provides a single device in which a flowable compound may be mixed and the dispensed into the vertebrae through the cannula. The mix and delivery device includes a piston, slidably disposed within a barrel of the device, for advancing the bone cement through an outlet communicating with the cannula. An actuating device, which exerts a pressure, is connected to an inlet on the mix and delivery device (either directly or through a tube). The pressure created by the actuating device is used to advance the piston within the mix and delivery device.

Abstract: The present invention discloses a technique for forming a hardened orthopaedic paste in a bone cavity, which involves a forced-feeding balloon rupture mechanism. This mechanism includes continuously or intermittently injecting a liquid or gas into a perforated balloon containing a hardened orthopaedic paste therein in a bone cavity until the perforated balloon is dilated to exceed a critical size, and thus ruptures.

Abstract: A syringe and a method of using the syringe are disclosed. The syringe includes a longitudinal body having proximal and distal ends and including an aperture between the proximal and distal ends. An injectable material, such as an adhesive bone cement, may be loaded into the body of the syringe through the aperture. After the injectable material is inserted, the aperture may be closed by covering the aperture with an aperture cover. The aperture cover may be configured to slide into a position covering the aperture, or the aperture cover may be placed in a position covering the aperture, such as by pivoting about a hinge. After the aperture is closed, the injectable material may be dispensed from the distal end of the syringe body by depressing a plunger. Depressing the plunger may initiate the closing of the aperture, or the aperture may be closed independently of plunger movement.

Abstract: Featured are a biocompatible, injectable, self-setting, cohesive, bone-bonding and remodeling calcium phosphate composite material and its use in methods of repairing defective bone, e.g., in vertebroplasty augmentation and kyphoplasty.

Abstract: A void containment apparatus and its method of use during an invasive procedure on the body are disclosed. The void containment apparatus includes an elongated housing and a balloon. The balloon is capable of being inflated and deflated. When inflated, the balloon provides a seal around a void and allows delivery or extraction of material into or out of the void with minimal leakage outside the void.

Abstract: Disclosed in certain embodiments is a pressure sensing tube for transporting a material under pressure through a lumen and a pressure sensitive material associated with the tube and operable to change in appearance in response to a physical change in the tube caused by pressure within the lumen. A method of manufacturing a pressure sensing tube is also disclosed.

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include a containment assembly for cement containment and/or a balloon assembly for maintaining vertebral height. Methods for treating a bone comprising: creating a cavity in the bone; inserting a containment jacket into the cavity; inserting a balloon into the containment jacket; inflating the balloon; and introducing a filler material into the containment jacket with isolation of the balloon from the filler material.

Abstract: A bone cement injection needle comprises: a hollow outer needle; an outer needle hub affixed to the base end part of the outer needle; an inner needle that can be slidably inserted into the hollow part of the outer needle; and an inner needle hub affixed to the base end part of the inner needle. The outer needle comprises a first side hole located near the tip; a second side hole located near the base end part; and a depressurization passage which connects the first side hole and the second side hole.

Abstract: Embodiments of the present disclosure are directed to devices, systems and methods for delivering viscous materials into a body, and more particularly, to devices, systems and methods for delivering bone fill material, biomaterials, and/or other flowable compounds into vertebrae, during, for example, a vertebroplasty procedure.

Abstract: The present invention discloses a technique for forming a hardened orthopaedic paste in a bone cavity, which involves a forced-feeding balloon rupture mechanism. This mechanism includes continuously or intermittently injecting a liquid or gas into a perforated balloon containing a hardened orthopaedic paste therein in a bone cavity until the perforated balloon is dilated to exceed a critical size, and thus ruptures.

Abstract: The invention relates to a biomaterial containing calcium phosphate, in particular hydroxyapatite or a material containing hydroxyapatite, such as biphasic calcium phosphates and calcium phosphate cements, and to the use thereof for the production of an implant or for fitting a prosthesis for the purpose of bone tissue regeneration.

Abstract: Methods and apparatus for performing a medical procedure which involves penetrating a bone structure are disclosed. According to one aspect of the present invention, a method for performing a surgical procedure includes introducing an assembly that includes a threaded cannula and a stylet into a bone structure. The threads have a shape that allows the cannula tip to be pushed into the bone body yet prevent the tip from being pulled out of the bone body. In one embodiment, the threads have a buttress shape. The method may also include applying a rotational motion, as for example a torque, to the threaded cannula to adjust the depth of insertion with respect to the implantation site when it is determined that the depth of insertion is to be adjusted.

Abstract: A cement restrictor for use in surgical procedures such as total hip replacement, for example, includes a pressure transducer and a transmitter electrically coupled to the pressure transducer. The cement restrictor is configured to be placed at a distal end of a pre-drilled bone canal in a patient's femur, for example, such that the pressure transducer may generate an output signal in response to the presence of bone cement injected into the bone canal and around the cement restrictor. The transmitter is configured to transmit this output pressure signal to an external receiver outside the patient's body.

Abstract: An injector device for percutaneously injecting biomaterial in the form of particles of different sizes or in the form of paste includes a trocar (12) of generally cylindrical shape presenting a open first end with a sharp edge, the wall of the first end presenting at least one orifice (36, 38) for passing the biomaterial, and a second end (42) that is likewise open; a reservoir (14) for receiving the biomaterial, the reservoir including a part (20) of substantially cylindrical shape having two open ends, the cylindrical part being capable of being inserted at least in a portion of the trocar via the second end thereof; removable plugs for closing both ends of the reservoir; and a piston (16) insertable in the cylindrical part when the plugs are removed, the piston being capable of sliding in the cylindrical part and in the first end of the trocar.

Abstract: A cavity creation device is introduced into a cancellous bone volume of a vertebral body through a percutaneous access path. The cavity creating device is manipulated to form a cavity in the cancellous bone volume. A volume of filling material is placed in the cavity by introducing a tube through the percutaneous access path and by conveying the filling material through a side dispensing port of the tube.

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: The disclosure is directed to a composition includes a first component and a second component. The first component includes a poly(methyl methacrylate) (PMMA), a contrast agent, and a radical donor. The second component includes methyl methacrylate (MMA), a radical scavenger, and a polymerization accelerator. The composition has an average setting time of about 13 minutes. The disclosure is further directed to a kit and a method of making the above-mentioned composition.

Abstract: An expandable body is inserted into an area of cancellous within a vertebral body through a percutaneous access path. A bone filler is conveyed into the expandable body to expand the expandable body and displace cancellous bone and create a cavity occupied at least in part by the expandable body and the bone filler. The expandable body and the bone filler are left within the cavity to strengthen the vertebral body.

Abstract: An elongated shaft is sized and configured to establish an access path to bone having an interior volume occupied, at least in part, by cancellous bone. The elongated shaft includes a generally closed distal end portion and a side opening spaced from the closed distal end. A first tool is sized and configured to be selectively inserted into the shaft and selectively removed from the shaft. The tool includes a region that, when the first tool is inserted into the shaft, is capable of being aligned with and advanced through the side opening to project outside the side opening and contact cancellous bone. A second tool is sized and configured, upon removal of the first tool from the shaft, to introduce into the shaft a bone filling material for discharge through the side opening into the cancellous bone contacted by the first tool.

Abstract: The method and apparatus as shown in FIGS. 8-10 in which a fluid expandable member (208) is positioned in concentric relation about a needle (202). The fluid expandable member (208) is expanded into the nucleus pulposus potential space bordered by the annulus fibrosus of an intervertebral disk. Then, thermoplastic material in a flowing state is injected by a needle (202) within the annulus fibrosus to collapse the fluid expandable member (208) and occupy the space formerly occupied by the fluid expandable member (208).