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: A bone cement delivery system for vertebroplasty with a cannula having a rigid metal tubular inner wall surrounding a central conduit with a distal outlet port, a rigid metal tubular outer wall extending around the inner wall to define a peripheral conduit with a distal inlet port in the form of fenestrations defined in the tubular outer wall, unobstructed and directly exposed to an environment of the delivery system, a proximal inlet port in communication with the central conduit and a proximal outlet port in communication with the peripheral conduit. A vacuum pump communicating with the proximal outlet port of the peripheral conduit applies a pressure in the range of 10 to 100 KPa to create a pressure gradient between the central conduit and the peripheral conduit to produce a difference in flow rate between the conduits guiding the displacement of bone fluid and the flow of cement.

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: 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: A pressurized syringe used to inject a viscous liquid through an adapter attached to a bone filler adapter into a cannulated surgical screw utilizing the cannulated surgical screw as a port to inject bone void filler into a bone void within a bone cavity during the course of a surgical repair to attach, repair and secure broken or separated bone fragments and providing a more secure bone anchor matrix within which the surgical screw is set.

Abstract: A discharge device discharges the content of a container by applying a compressed gas. The device has a housing, at least one compressed gas container, an operating device for setting a gas flow from the compressed gas container and an opening means for opening the compressed gas container. The opening means is movable in relation to the compressed gas container, and the device has a holder for securing the container on the device. The holder is in operative connection with the opening means in such a way that securing the container on the holder brings about a movement of the opening means in relation to the compressed gas container that opens the compressed gas container.

Abstract: A length-adjustable vertebral body balloon catheter in which the location of the balloon can now be manipulated once an access cannula has been placed in the vertebral body.

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 method of applying bone cement for an orthopedic procedure of a patient includes coupling a proximal end of a nozzle component to a bone cement applicator and applying bone cement on a surface of an implant or on a bone surface through an elongated distal opening of a distal portion of the nozzle component. The method includes separating the distal portion from an intermediate portion of the nozzle component at a frangible connecting portion and exposing a circular distal end of the intermediate portion.

Abstract: An applicator and applicator kit for particulate bone replacement materials, autologous or heterologous cancellous bone, demineralised bone matrix. The applicator (1) contains a hollow tube (12) including on one end a bladed shutter. The applicator comprises first fastener (15) for engaging a second component. The second component contains a rod (2) with a handle (21) on one end and a plunger (22) on the opposite end. The rod is arranged in a guide sleeve which is moved along the rod (2) and comprises second fastening means (23) that can be connected to the fastener (15) of the applicator (1) in reversible manner. The applicator kit contains a mixing cup connected to the tube (12) instead of the rod such that the material to be applied is filled into the tube (12) easily prior to application.

Abstract: A calcium-based bone cement formula having a powder component and a setting liquid component with a liquid to powder ratio of 0.20 ml/g to 0.50 ml/g is provided, wherein the powder component includes tetracalcium phosphate. The bone cement formula further contains, based on the total weight of the bone cement formula, 0.01-1% of poly(acrylic acid) having a repeating unit of —(CH2—C(COOH)H)n-, wherein n=50-50000.

Abstract: A bone cement comprising a first component and a second component, wherein contacting the first component and the second component produces a mixture which attains a high viscosity an initial period and the viscosity of the mixture remains relatively stable for a working time of at least 5 minutes after the initial setting period, and the mixture is suitable for in-vivo use.

Abstract: A bone cement delivery unit having a rigid support structure with a first portion configured to engage and retain a bone cement reservoir against its casing, a second portion supporting a transmission system and a third portion supporting and guiding a slidable push rod along the injection direction. The delivery system may include a control unit sliding the push rod opposite to the injection direction before stopping the push rod if the quantity of the bone cement pushed out of the reservoir has reached at least a predetermined minimum value, such as to eliminate residual flow. Also, the delivery system may include an adaptor including members electrically connected to the control unit, with the cement reservoir including a sensor for monitoring curing of the bone cement in electrical contact with the members of the adaptor.

Abstract: A delivery device for semi-solid implantable material such as synthetic bone graft substitutes. The device comprises a handle (1), a cylinder (2) extending from the handle and having an outlet at its distal end. A piston (23) is operated by a trigger (5) and is slidable within the cylinder to displace the material from the cylinder. The cylinder has a substantially constant inner diameter along its entire length such that the outlet has substantially the same inner diameter as the rest of the cylinder. When the trigger is fully depressed, a ratchet mechanism (14, 32) is disengaged allowing the piston to be pulled back to a starting position.

Abstract: Minimally invasive methods of using a composition including bone cement to secure a hip or other prosthetic implant that has loosened following the initial implant surgery are disclosed. The methods include delivery of a composition including one or more bone cements alone, or in combination with one or more additives and/or fillers to the site of a loosened implant-bone interface. Devices suitable for use in the method are also described.

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: A delivery gun for discharging bone cement from a cartridge that includes a piston. The gun has a casing from which a drive rod and a disk extend. A drive assembly advances the drive rod and disk so that disk displaces the piston causing the discharge of cement. The drive assembly includes plural links that are pivotally connected to a trigger. The links are displaced in response to the manual displacement of a trigger. One of the links is configured to selectively engage the drive rod. When this particular link is engaged with the drive rod and displaced, the drive rod the drive rod is advanced at a first speed. When this link does not is not engaged with the drive rod, the drive rod is advanced by another link at a second speed.

Abstract: A bone cement comprising a first component and a second component, wherein contacting the first component and the second component produces a mixture which attains a high viscosity an initial period and the viscosity of the mixture remains relatively stable for a working time of at least 5 minutes after the initial setting period, and the mixture is suitable for in-vivo use.

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 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 assembly for injecting bone cement into a vertebral body, comprising a bone cement dispenser, an introducer needle, a cement injection needle attached to the cement dispenser and slidably received in the introducer needle, and a Touhy-Borst adapter that locks and unlocks the cement injection needle from the introducer needle.

Abstract: A non-aqueous hydraulic cement composition comprises a non-aqueous mixture of (a) ?-tricalcium phosphate powder, (b) monocalcium phosphate comprising monocalcium phosphate anhydrous (MCPA), monocalcium phosphate monohydrate (MCPM), or a combination thereof, and (c) non-aqueous water-miscible liquid, wherein a 0.1 g/ml saturated aqueous solution of the monocalcium phosphate has a pH less than 3.0. Methods of producing a hardened cement, hardened cements, kits, and articles of manufacture employ such compositions.

Abstract: An apparatus 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 minimal access method for mammalian vertebrae interbody fusion without the employment of an interbody device is described which comprises injecting a porous CaPC into an anterior portion of a disc space, and injecting an effective amount of fast-setting non-porous CaPC into an anterior portion of the disc space to rapidly produce a strong and stable interbody fusion without the employment of an interbody device. Methods are further described wherein at least one of the CaPCs comprises an effective amount of at least one osteoinductive protein. A minimal access method for vertebroplasty is described which comprises injecting an effective amount of a viscous non-porous CaPC into a vertebrae fracture channel to provide rapid stabilization and strength, and injecting a porous CaPC into trabecular bone space adjacent to the vertebrae fracture channel. Kits which relate to the methods of the present invention are described as well.

Abstract: A method for utilizing an adapter attached between a syringe filled with a bone void filler and the head of an inserted cannulated surgical screw during the process of a surgical repair to a bone allows the cannulated surgical screw to be used as a port to inject bone void filler into a bone void in the bone during the surgical repair which would use a surgical screw to attach broken or separated bone fragments, the bone void filler within the bone providing a more secure bone anchor matrix within which the surgical screw is set.

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: A bone filler mixing and delivery device includes a mixing section adapted to mix components to form bone filler. A syringe barrel is coupled to the mixing section and has an opening through which the bone filler can be dispensed. A controllable portal can be manipulated to open a flow path between the mixing section and the syringe barrel. A plunger assembly is adapted to extend telescopically in an axial direction through the syringe barrel to dispense the bone filler through the opening.

Abstract: A system for forming an implant to stabilize an interior of a vertebral body is provided. The system includes a delivery cannula (18) in which there is an agglomeration of beads (20) and cement (22). A membrane is disposed over the open end of the cannula. When the agglomeration is discharged from the cannula it fills the membrane. The membrane thus forms the outer shell of the implant internal to the bone.

Abstract: Apparatuses and methods for reinforcing weakened or fractured bone are disclosed. An apparatus for delivering a bone reinforcing mixture to a bone includes a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen capable of allowing a bone reinforcing mixture to pass through, and a bone fitting portion having an opening for accepting the tube, an insertion portion for insertion into the bone, and at least one relief valve.

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: 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: An outer needle of a bone cement injection puncture needle has first side holes near the tip, and second side holes near the base. When an inner needle is removed from the outer needle and an inner tube is inserted into the outer needle in place thereof, a reduced-pressure passage is formed between the outer needle and the inner tube. When bone cement is injected into a bone, gas and liquid in the bone pass through the reduced-pressure passage and are discharged from the body, thereby preventing increased pressure in the bone. As a result, the bone cement can be prevented from leaking to outside of 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: Devices, instruments and associated methods for the subchondral treatment of osteoarthritis in hip and shoulder joints are provided. In addition, a method for treating joint pain is provided. The method comprises: identifying a subchondral defect in a subchondral region of a bone of the joint; selecting a subchondral access path to a location near the subchondral defect; and treating the subchondral defect, via the subchondral access, in a manner that restores normal force distribution and joint function while preserving the articular surface of the bone, wherein the joint is a hip or shoulder.

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. A method of treating bone includes injecting a volume of fill material into a bone and selectively modifying a viscosity of the bone filler to control the direction of flow of the fill material within the bone. A system for treating bone using this method includes an introducer for delivering fill material into the bone and an energy source selectively coupleable to the fill material to alter the viscosity of the fill material via an energy emitter.

Abstract: Described herein is a novel drug delivery assembly having particular applicability to the field of orthopedic and surgical medicine. The devices and assemblies described herein enable the efficient application and retention of potentially expensive therapeutic materials to very specific locations, particularly those associated with voids in bone and tissue. One particularly unique aspect of the present invention involves the introduction of constructs which promote the retention of therapeutic material in the target area of application for beneficial use, for example by forming a proximal barrier that prevents leakage of the therapeutic material out of the target area. Additionally, the present invention provides unique devices and methods for surgical introduction of such constructs.

Abstract: An apparatus and methods for delivery of reinforcing materials to a weakened or fractured bone is disclosed. An apparatus for delivering a reinforcing mixture to a bone including a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen capable of allowing a bone reinforcing mixture to pass therethrough; a balloon engaging the tube wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon; and at least one light guide extending through the tube into the balloon to guide a light into the balloon.

Abstract: A bone tap may be used to deliver and/or aspirate fluid to and/or from a bone. The bone tap may include a passage. A distal portion of the bone tap may be threaded. In some embodiments, openings in a distal portion of the bone tap may communicate with the passage. The bone tap may be driven into bone, and material may enter or exit the bone through the openings and passage.

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 a cavity creation element, such as an inflatable balloon. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Abstract: Biocompatible material for bone repair, especially vertebral bone repair, preferably has three components. The first component is silicon nitride ceramic spheres or shells that can be polyhedral in shape. When grouped together, these ceramic spheres or shells form tessellates having a similar degree of stiffness, strain and stress resistance to cancellous bone. The second component comprises various bioactive factors that are preferably osteoconductive, osteoinductive and osteogenic. The third component is a liquid or gel that combines with the first and second components to form a composite.

Abstract: The present invention 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 hydraulic pressure source is 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 curable material delivery cannula device and method are disclosed. The device includes a cannula and a hub. The cannula includes an open proximal end, a deflectable segment forming a plurality of pre-set curves, each of which corresponds to a pre-determined temperature of the cannula, a lumen, and side orifice(s) adjacent, and proximally spaced from, the distal end and fluidly connected to the lumen. When distally extended from the guide cannula, and upon being heated to a predetermined temperature (before, during, or after extension), the deflectable segment assumes a curved shape, which may be used to create a void in the bone for receiving curable material. The distal cannula end includes 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.

Abstract: A bone filler delivery system comprises a longitudinal channel incorporates a perforated segment at least partially along, at or near its distal end. The channel can be sealed at its distal end so the filler material may be delivered only by the lumen and through the perforated segment. Optionally, said system comprises a permeable bag capable of being inserted into a bone while in collapsed configuration and then expanded 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 allows exudation of bone void filler through its walls. Extracting the permeable bag out of a treated body promotes flow of bone void filler through its pores into cancellous bone and/or cavity in the bone. The procedure promotes height restoration of the bone and introduces filler in a controlled manner.

Abstract: A delivery device for a monomer may include an elongate container designed to enclose one or more ampoules containing the monomer. The elongate container may include: a connection at a first end of the elongate container for delivering the monomer to a mixing device, pre-filled with a polymer, for preparation of bone cement composition under vacuum; a cap at a second end of the elongate container; at least one air inlet aperture in a wall of the elongate container; and a manually actuatable element for opening the one or more ampoules. The manually actuatable element may include: a knob; a draw rod; and one or more spikes. The knob may be in threaded engagement with the draw rod. An end of the draw rod may extend past the one or more ampoules. Turning the knob may cause the one or more spikes to penetrate the one or more ampoules.

Abstract: An apparatus and methods for delivery of reinforcing materials to a weakened or fractured bone is disclosed. An apparatus for delivering a reinforcing mixture to a bone including a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen capable of allowing a bone reinforcing mixture to pass therethrough; a balloon engaging the tube wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon; and at least one light guide extending through the tube into the balloon to guide a light into the balloon.

Abstract: A cavity creator including a tube with a lumen. A tip able to penetrate bone extends forward from the distal end of the tube. A blade is moveably attached to the outer tube proximal to the tip so as to move between retracted and extended states. The tube has a discharge port adjacent the blade. The tip is used to position the upper tube in bone. The blade is extended to form a cavity in the bone. Once the cavity is created filler material can be introduced into the cavity by flowing the material through the tube lumen.

Abstract: Apparatus and method to dispense PMMA bone cement including a temperature controller, a disposable cement cartridge and a means for extracting cement from the cement cartridge so that the temperature of the extracted cement is first cooled to discourage polymerization and to prolong working time, then warmed so as to control viscosity of the cement flowing into the desired bone repair location. A first embodiment includes a spiral cement cartridge along with a means for extracting cement therefrom. A second embodiment includes a linear disposable cement cartridge along with a means for extracting cement therefrom. A color matching mechanism identifies cement temperature and viscosity during dispensation. A manual cement dispensing method includes a calibrated hand crank mechanism for causing calibrated delivery of cement. An automatic cement dispensing method uses a stepper motor and computer programmed means for causing calibrated flow of cement.

Abstract: A medicine injection device includes a medicine ejection unit having a fluid flow-in port for receiving liquid, and a pressure generation unit which includes a pressure generating chamber to generate pressure acting upon a working chamber of the medicine ejection unit through the liquid and which ejects medicine by moving a gasket based on the applied pressure. The pressure generation unit includes a pressure portion cylinder in the pressure generating chamber, a first pusher provided with a hollow gasket defining the inner volume of the pressure generating chamber and a second pusher which generates the pressure inside the pressure generating chamber by pressing a distal end head portion into the inside of the pressure generating chamber. The pressure portion cylinder and the first pusher are coupled through an engagement mechanism in which fixation and fixation release are possible at different pitches in the axial direction.

Abstract: A hydraulic injection system is provided for injecting bone cement to a target anatomical location. The injection system can include a hydraulic injector configured to dispense a pressurized fluid, a cement cartridge assembly, and one or more conduits. The cement cartridge assembly includes at least one cement cartridge configured to receive the pressurized fluid and deliver the bone cement to the target anatomical location. The conduit is connected between the hydraulic injector and the cement cartridge assembly.

Abstract: A percutaneous path is established into a selected bone having an interior volume occupied, at least in part, by a cancellous bone, e.g., a vertebral body. An expandable stent structure is introduced into the cancellous bone by deployment of a tool through the percutaneous path into the cancellous bone. The expandable stent structure is expanded within cancellous bone.