Abstract: Cancellous bone is accessed through a subcutaneous access path in soft tissue. A cavity is formed in cancellous bone by a cavity forming tool that is advanced through the subcutaneous access path into cancellous bone and manipulated to form the cavity. A measured volume of bone filling material is delivered into the cavity through the subcutaneous access path by a nozzle having an interior bore defining an interior volume sized for containing bone filling material, which is advanced through the subcutaneous access path. A nested instrument is formed while clearing residual bone filling material from the interior bore by an auxiliary tool that can be manipulated independently of the nozzle, which is advanced through the interior bore of the nozzle.

Abstract: The present invention is directed to a system and method for percutaneous delivery of bone cement during a surgical procedure. The system of the present invention has a plunger assembly 100, comprising: a shaft having a first end, a middle section, and a second end, wherein the middle section is threaded; and a handle attached to the first end of the shaft. The system further comprises a dispenser hub assembly 200 around the shaft having a collar and a hand-grip attached to the collar, and a threaded portion formed on an interior surface of the collar. The system may further comprise a hollow tube 300 for containing the bone cement during the surgical procedure having a first end and a second end, the first end of the hollow tube adapted to be removably engaged with the threaded portion of the dispenser hub assembly. The shaft is axially displaceable through the hollow tube for controlled displacement of the bone cement through the second end of the hollow tube.

Abstract: Systems and methods treat fractured or diseased bone by deploying more than a single therapeutic tool into the bone. In one arrangement, the systems and methods deploy an expandable body in association with a bone cement nozzle into the bone, such that both occupy the bone interior at the same time. In another arrangement, the systems and methods deploy multiple expandable bodies, which occupy the bone interior volume simultaneously. Expansion of the bodies form cavity or cavities in cancellous bone in the interior bone volume.

Abstract: Instrumentation and method for treatment of a spinal structure, comprising an elongate member including a deformable distal portion having an initial configuration for placement within the spinal structure and a deformed configuration wherein the distal portion is outwardly deformed to form a cavity in the spinal structure. The elongate member comprises a cannula member and an actuator member that is removably positioned within the cannula member and configured to transition the deformable distal portion from the initial configuration toward the deformed configuration. The actuator member is selectively removed from the cannula member to provide a passageway for delivery of a material into the cavity formed in the spinal structure.

Abstract: Described herein are devices, systems and method for assuring that connection regions (e.g., threaded regions) of stabilization devices are clear of bone filling materials such as bone cements. A stabilization device may be referred to as a bone stabilization device or an anchor, and may be a self-expanding device configured for insertion into bone. One exemplary clearing device is configured as a plunger-type device for clearing the connector region by scraping and/or rubbing the surface of the connector region. A clearing device may include a handle, a rod and a connector end that is configured to mate with the connector of a stabilization device. The connector end may include one or more scraping surfaces (e.g., edges) and may include a vacuum port for removing material such as scraped bone cement.

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 method and apparatus is disclosed for providing implants in the upper jaws of a person. A sleeve is inserted through the alveolar ridge to the maxillary sinus. The sleeve is used to raise the subantral membrane and form a cavity. A filler, such as a bone growth stimulant is injected through the sleeve into the cavity. In the process, the sleeve also can cut and/or condense the bone around itself so that the bone can hold an implant. Optionally, the bone growth stimulant is also introduced into the bone surrounding the sleeve. During the injection, the pressure within the sleeve or the cavity is monitored to detect and prevent the rupture of the subantral membrane.

Abstract: Surgical methods of repairing defects and deficiencies in the spine are disclosed. The methods involve delivering a single part in-situ polymerizing fluid to (i) close a weakened segment or fissure in the annulus fibrosus, (ii) strengthen the annulus, (iii) replace or augment the disc nucleus, or (iv) localize a disc prosthesis. The methods may include placing a delivery conduit adjacent to the repair site and providing a liquid tissue adhesive to bond to and repair a disc defect or deficiency.

Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: Systems, bone cements and methods for treating vertebral compression fractures can utilize a bone cement comprising of a mixable liquid monomer component and a non-liquid component including polymer particles, wherein the non-liquid component is configured for controlled exposure to the liquid monomer over a setting interval of the bone cement. In a method of use, liquid and non-liquid components are mixed, and the bone cement is injected into bone wherein a lengthened setting interval is provided in which the mixture is configured for a flowability that prevents unwanted extravasation.

Abstract: An implant includes a tool receiver for coupling to an implantation tool and also a connecting device for connecting the implant to an injection cannula for the purposes of injecting a bone bonding material in such a manner that the handling and production thereof are simplified. The connecting device may include an internally threaded section which is formed in or on the tool receiver. An implantation system includes at least one injection cannula and at least one implant.

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 housing having a chamber configured to contain a first and second bone cement. A plunger including a plunger rod having a piston at a first end and a plunger handle at a second end is configured to actuate within the chamber. A mixing element is disposed adjacent the piston and is configured to rotate within the chamber to mix the first and second bone cement components to form the bone cement mixture. The plunger is configured to rotate the mixing element to mix the bone cement mixture. The plunger is also configured to advance through the chamber. As the plunger is advanced through the chamber, the piston is configured to receive the mixing element and dispense the bone cement mixture from the device.

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: 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 lesion or fistula isolating bag, the bag defining a first chamber having a closeable entrance and a second chamber for application to a lesion or fistula and wherein access to the second chamber is made through the first chamber via a valve, the valve being arranged to inhibit passage of fluid from the second chamber to the first, and to allow said access from the first chamber to the second, the bag further comprising a closure for said closeable entrance.

Abstract: A pressure applicator for applying pressure to a flowable implant material, e.g., PMMA. A pressure applicator or driver includes a pair of columns which are engageable with one another, preferably by threads to generate a driving pressure. A handle is provided for the operator to grasp and steady the device as he turns the handle to apply pressure to the implantable material within the applicator. A luer-lock or other connecting device is provided for attaching the applicator to a cannula (or a connecting conduit that in turns connects with a cannula) that will deliver the implant material to the desired site. Pressures of about 1000-3000 psi may be generated by this device.

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: Delivery devices and methods to be used in the delivery of filling/stabilizing and/or therapeutic materials to a bone or other targeted anatomical site. The disclosed devices desirably control the flow of material, measure the volume of material delivered to the site of interest, and prevent the placement of materials in unintended locations. These disclosed devices desirably combine multiple uses of mechanical control of the filler/stabilizing material delivery, rotational advancement of syringe mechanisms in combination with the advantages of manual displacement of filling/stabilizing material from a cannula/stylet pair.

Abstract: Novel kits are provided for the delivery of restorative or injectable compositions into an intraosseous space or surgical defect comprising cannulae for accessing an intraosseous space, mandarins insertable into the cannulae and movable therein, one or more catheters and a system for the delivery of aliquots of restorative compositions into the space via the catheters.

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. 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: 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. 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: In at least one embodiment of the present invention, a method for stabilizing a collapsed vertebra of a patient is provided. The method comprises introducing a supercooled liquid into the collapsed vertebra. A solid structure that supports the collapsed vertebra is then form by solidifying the supercooled liquid.

Abstract: A cement delivery system for vertebroplasty including a rigid cannula having a tubular inner wall defining a central conduit to deliver bone cement and a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit for aspirating bone fluids. Aspirating means communicate with a proximal outlet port of the peripheral conduit to create a pressure gradient between the central conduit and the peripheral conduit to provide a hydraulic force guiding the displacement of bone fluid and the flow of cement. Also, a bone cement delivery system including a rigid cannula having a tubular inner wall defining a central conduit, a tubular outer wall extending around the inner wall and spaced apart therefrom to define a peripheral conduit, and a tubular middle wall extending between the inner and peripheral walls and spaced apart therefrom to define a middle conduit around the central conduit.

Abstract: A method of stabilizing adjacent vertebrae including the steps of forming at least one annulotomy in an annulus. At least a portion of the nucleus material is removed through the annulotomy to form a cavity in an intervertebral disc space between the adjacent vertebrae. A reservoir containing a flowable biomaterial is fluidly coupled to the intervertebral disc space. A flowable biomaterial is delivered to the cavity. The delivery of the flowable biomaterial into the intervertebral disc space is controlled in accordance with at least a first operating parameter. The biomaterial is at least partially cured to stabilize the adjacent vertebrae.

Abstract: A temporary femoral implant system has a porous mold and a femoral component. The system fits at least partially in a femoral cavity. The mold has a wall with an interior surface and an exterior surface forming an interior space for receiving an antibiotic bone cement. The mold allows the antibiotic to diffuse through the wall to the exterior surface. The femoral component has a stem portion received within the mold. A method of using the implant system includes providing an implant system comprising a mold and a femoral component, inserting the mold into the femoral cavity with the exterior surface facing the femoral cavity, inserting the stem portion of a femoral component into the interior space of the mold and filling the interior space of the mold with an antibiotic bone cement.

Abstract: A medical implantation device for spine is disclosed which includes a flexible container with one end thereof being provided with an infusion end and having one or more layers of flexible peripheral wall; and a tubular component receiving the flexible container with the infusion end and another end of the flexible contained exposing from two ends of the tubular component, and the tubular component is to be implanted between two adjacent spinous processes; wherein the tubular component has an outer diameter greater than a distance between the two adjacent spinous processes, and a medical filling is infused into the flexible container via the infusion end thereof, so that an inflation of a middle section of the flexible container is restricted by the tubular component and the infusion end and the another end of the flexible container are inflated to be movably pressed on the two sides of the two adjacent spinous processes.

Abstract: A method for applying bone cement into a bone structure that includes the steps of: selecting at least one region in a bone where the trabecular bone structure is to be augmented, producing at least one cavity (20) communicating with said at least one bone region, applying a fluid jet lavage towards said at lest one bone region, and providing bone cement to said at least one bone region.

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: Systems and method create a cavity in cancellous bone by use of a system or kit that includes a cannula having an axis that establishes a percutaneous path leading into bone and a shaft having a distal end portion carrying an elongated loop structure or bristles capable of extension from the shaft to create a cavity forming structure. The shaft is movable relative to the axis of the cannula to move the cavity forming structure when extended within cancellous bone to form a cavity in the cancellous bone. A tool is sized for passage through the cannula. The tool is capable of dispensing a filling material into the cavity.

Abstract: The present invention relates in certain embodiments to systems and methods for treating bone, such as vertebral compression fractures. In one embodiment, a method includes controllably applying energy from an energy source 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 of the bone fill material into a bone. The method further includes sequentially introducing a plurality of cement carrying structures with said accelerated polymerization rate bone cement volume into the bone. A system for use in said 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.

Abstract: An expandable device is introduced into a cancellous bone volume of a vertebral body through a percutaneous access path. The expandable device is expanded while disposed within the cancellous bone volume to create a cavity. A volume of filling material is placed within the cavity. The filling material includes a therapeutic substance.

Abstract: A vertebral body is selected for treatment. The vertebral body has a cortical wall enclosing a cancellous bone volume. The vertebral body also has at least one cortical plate that is depressed due to fracture. At least one maximum dimension for the cancellous bone volume is ascertained, and an expandable device is provided that has a predefined dimension when substantially expanded that is less than the maximum dimension. The expandable device is introduced into the vertebral body through a percutaneous access path while in an unexpanded condition. The expandable device is expanded while disposed within the cancellous bone volume from the unexpanded configuration toward the expanded configuration. An expansion barrier is provided in association with the expandable device that directs expansion of the expandable device in a desired direction to move the fractured cortical plate toward a desired anatomic position.

Abstract: An expandable device is introduced into a cancellous bone volume of a vertebral body through a percutaneous access path. The vertebral body has at least one cortical plate that is depressed due to fracture. The expandable device is expanded while disposed within the cancellous bone volume. An expansion barrier placed in association with the expandable device directs expansion of the expandable device in a desired direction to move the fractured cortical plate toward a desired anatomic position.

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: 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: 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: Devices and kits, and methods of their use, for the delivery of viscous compositions are described.

Abstract: The present invention relates to expandable semi-compliant devices that may be used for the treatment of diseased or injured bone tissues, and methods of using the same. The semi-compliant device of the present invention is inserted into an interior space of a cancellous bone tissue, and is filled with a suitable material to provide internal structural support to the bone. The semi-compliant device may further comprise a polymer or a polymer surface coating of a biocompatible polyphosphazene polymer such as poly[bis-(trifluoroethoxy)phosphazene] or derivatives thereof. Such semi-compliant devices or surface coatings may also act as carriers for medicinal, radiological, or thermal treatments of diseased bone.

Abstract: A bone cement cannula, the cannula comprising: a tube including a section adapted for plastic deformation; and a lumen in the tube capable of resisting forces of a viscous material propelled therethough at a pressure of at least 100 atmospheres.

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 apparatus (20) is provided. In an embodiment, the apparatus includes a syringe (24) and a needle (120). The syringe and needle are interconnected by a connecting tube (32). Various fittings are employed to join the syringe, needle and connecting tube. The connecting tube and fittings present a pathway along which bone cement is carried. The connecting tube, fittings, and needle are all configured such that a substantially uniform pathway is provided from the end of the syringe to the end of the needle.

Abstract: Bone cement formulations are provided that have an extended working time for use in vertebroplasty procedures and other osteoplasty procedures. In one embodiment, a settable bone cement includes a polymerizable composition with a powder component comprising an X-Ray contrast medium and a liquid component, wherein the setting time of the cement is at least about 25 minutes, at least about 30 minutes, at least about 35 minutes, and at least about 40 minutes.

Abstract: In a method and a device for improving the fixing of an elongate prosthesis in a bone cavity, said fixing being provided by a bed in which the prosthesis has been driven down by vibration, a ring of a flexible, essentially plastic material is arranged around the proximal part of the prosthesis so that the ring fills the space between the bone wall and the prosthesis, whereupon the ring is compacted and compressed, after which strokes are made on the prosthesis in its longitudinal direction for final fixing thereof in the bed. The ring significantly improves the strength of the prosthesis in the bed.

Abstract: A device for preparing and ejecting polymeric cement made from at least two pre-packaged components comprises a tubular vessel including a first axial end wall having a closed outlet, and a second axial end wall having an aperture. A first starting component of the polymeric cement is present inside said tubular vessel near the first axial end wall. A hollow shaft extends through said aperture of the second axial end wall. A piston element comprises a closed container filled with a second starting component of the polymeric cement. The piston element is selectively lockable to the shaft. The container has a bore and is slidingly engaged upon said shaft. An agitator element is secured to one end of the shaft. Furthermore opening means for providing an opening in the closed container are provided. The hollow shaft is provided with a gas permeable filter means.

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: An assembly for sealably injecting a fluent material into an intradiscal space accessed through an opening in the annulus of a spinal disc comprises a cannula having a passageway for injecting the fluent material therethrough into the intradiscal space, a seal having a sealing surface for sealing engagement with the outer surface of the disc annulus and defining a central opening for, and an articulating joint defined between the central opening of the seal and the cannula configured to permit relative articulation between the components. The assembly may further comprise an anchor element extending through the central opening of the seal, the anchor element including an elongated threaded body sized for threaded engagement within the opening in the disc annulus and having a head configured to engage a distal end of the cannula.

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: The present invention relates in certain embodiments to methods, systems, and devices for treating vertebral compression fractures. In one embodiment, a bone cement injector is advanced into bone and injects a bone cement flow through the injector and a vapor flow from at least one vapor outlet in the injector. In another embodiment, the bone treatment system comprises an elongated member having a flow passageway, a bone fill material source, and a vapor source coupleable to the flow passageway. Still another embodiment describes a vapor injection device having an elongated member with a flow passageway, the elongated member configured for insertion into a bone and for delivering a bone fill material through the flow passageway, and having at least one vapor channel in communication with the flow passageway to deliver a vapor into the flow passageway to heat a bone fill material flow.

Abstract: A vertebral body having an interior volume occupied, at least in part, by cancellous bone is selected for treatment. A percutaneous path is established into the vertebral body. A tool is introduced through the percutaneous path that creates a cavity in the cancellous bone. A bone filling material is conveyed to substantially fill the cavity. The bone filling material is pressurized within the cavity to enlarge the cavity.

Abstract: A method selects a vertebral body having an interior volume occupied, at least in part, by cancellous bone. The vertebral body has at least one cortical plate that is depressed due to fracture. The method establishes a percutaneous path into the vertebral body. The method introduces through the percutaneous path a tool that forms a region of compressed cancellous bone. The method conveys a bone filling material through the percutaneous path into the region to move the fractured cortical plate toward a desired anatomic position.