Abstract: The present invention relates to medical devices, systems and methods for restoring spinal disc function. The invention provides a curved path through the vertebra into the disc through which the disc can be filled with an augmenting substance, balloon, or pellets. Further, the delivery device can be used to access the disc with surgical instrumentation. The invention further discloses a responsive disc augmentation system.

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: The present invention is related to a technique for simultaneously forming a plurality of paste filled tunnels. The plurality of paste filled tunnels are connected to a surgical tube directly or indirectly and emptied one after another, until a desired amount of the paste is injected into a bone cavity, organ or a tissue via the surgical tube. The paste may be a bone cement paste, a drug powder paste, viscous fluid or gel. The injected bone cement paste will set in the bone cavity to act as a medical implant.

Abstract: A mixing apparatus comprises a cylindrical body extending between proximal and distal ends. The cylindrical body has a hollow interior and an outlet at the distal end. The mixing apparatus also includes a plunger having an elongated shaft with a distal end, a first mixing plate with a first plurality of holes extending therethrough, and a second mixing plate with a second plurality of holes extending therethrough. The first and second mixing plates have a first relative position, adapted for mixing, in which the first and second plurality of holes are aligned. The mixing plates have a second relative position, adapted for material dispensing, in which the first plurality of holes are blocked by the second mixing plate.

Abstract: Devices, systems and methods for delivering a curable, stabilizing material into a central region of a bone structure. Precise placement of the curable substance into a central region of a bone structure through a unipedicular approach. One primary advantage is its ability to create a central cavity in a vertebral body (or to centrally deliver bone cement) through a unipedicular approach. A curved needle having increased rigidity in its flexible end when the end is disposed in its straight position. This increased rigidity is due to a novel tensioning mechanism and to a segmented tube design (as opposed to the conventional longitudinally-slotted tube design).

Abstract: The invention comprises a method for introduction of materials into a patient's body. The method generally comprises providing an elongate member for introducing the material. The elongate member defines a lumen and comprises a distal end defining an aperture and a proximal end. The method further comprises the steps of positioning the elongate member at a target site of a patient's body; providing a motorized device at least partially disposed within the lumen; and introducing the material through the lumen into the target site using the motorized device.

Abstract: Methods of employing bone defect filling, e.g., orthopedic cements, such as calcium phosphate cements and the like, are provided. A feature of the subject methods is that vibration is employed in conjunction with the use of the cement, e.g., in preparation of the cement, in preparation of the target site, in delivery of the cement to the target site, and/or following delivery of the cement to the target site. Also provided are devices, systems and kits that find use in practicing the subject methods. The subject methods, devices and systems find use in a variety of different applications.

Abstract: An apparatus for stabilizing a vertebral body using a structural support to stabilize the vertebral body. The apparatus includes a first curable material deposit proximal to a first endplate of a vertebral body for providing support to the first endplate of the vertebral body and a second curable material deposit proximal to a second endplate of a vertebral body for providing support to a second endplate of the vertebral body. The apparatus also utilizes a stabilizing structure between the first curable material deposit and the second curable material deposit and connecting the first curable material deposit and the second curable material deposit for providing support to the vertebral body.

Abstract: Among other things, an apparatus for mixing and dispensing a bone cement mixture are provided. In certain embodiments, the apparatus includes a housing having a first chamber for containing an ampoule having a first bone cement component. The housing has a second chamber for containing a second bone cement component and the first and second chambers are in fluid communication. An ampoule breaking device is disposed within the first chamber and is configured to engage and break the ampoule for release of the first bone cement component. Disposed within the second chamber is an impeller that is configured to rotate such that the impeller mixes the first and second bone cement components together to form the bone cement mixture. Adjacent the impeller is a displacer that is configured to advance through the second chamber, receiving the impeller and dispensing the bone cement mixture.

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

Abstract: Methods and devices are shown for forming polymer fasteners into bone by expelling the polymer from a cannula. Devices and methods shown allow a user to form multiple fasteners of various sizes without re-loading a device. Devices and methods shown further provide temperature profiles during fastener formation that reduce or eliminate thermal necrosis. Devices and methods shown further provide fasteners with increased strength.

Abstract: Among other things, an apparatus for mixing and dispensing a bone cement mixture are provided. In certain embodiments, the apparatus includes a housing having a first chamber for containing an ampoule having a first bone cement component. The housing has a second chamber for containing a second bone cement component and the first and second chambers are in fluid communication. An ampoule breaking device is disposed within the first chamber and is configured to engage and break the ampoule for release of the first bone cement component. Disposed within the second chamber is an impeller that is configured to rotate such that the impeller mixes the first and second bone cement components together to form the bone cement mixture. Adjacent the impeller is a displacer that is configured to advance through the second chamber, receiving the impeller and dispensing the bone cement mixture.

Abstract: A medical device includes a tubular body having a first lumen so designed as to receive a fluid from an opening at one end of the first lumen and discharge the fluid from an opening at the other end of the first lumen, and an expandable body attached to the tubular body. The first lumen communicates with the space inside the expandable body and the expandable body expands by the internal pressure of the fluid which is injected from the opening at one end and enters the space inside the expandable body through the first lumen.

Abstract: Introduction of a bone filler material into at least a portion of the cancellous bone volume pressurizes the bone filler material and compresses the cancellous bone volume within the bone structure.

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 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: Systems and methods for repairing a weakened or fractured bone are disclosed herein. A system for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen for passage of a mixing element; an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device moves from a first compact state to a second expanded state when the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device; and a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device.

Abstract: A cement-directing structure for use in cement-injection bone therapy includes a collapsible, self-restoring braided structure with regions of differential permeability to the bone cement. The regions of differential permeability may be provided by areas where the braided mesh density is greater or lesser than surrounding areas and/or by means of a baffle. After the structure is placed in a void within a bony structure, cement is injected into the interior of the structure then oozes out in preferred directions according to the locations of the regions of differential permeability.

Abstract: Methods of employing bone defect filling, e.g., orthopedic cements, in conjunction with hard tissue securing devices, e.g., screws, plates or rods, are provided. A feature of the subject methods is that the cement is introduced to a target bone site through a passageway of the securing device while a vibratory force is applied to the securing device. Also provided are systems and kits that find use in practicing the subject methods. The subject methods, devices and systems find use in a variety of different applications.

Abstract: Methods and devices are shown for forming polymer fasteners into bone by expelling the polymer from a cannula. Devices and methods shown allow a user to form multiple fasteners of various sizes without re-loading a device. Devices and methods shown further provide temperature profiles during fastener formation that reduce or eliminate thermal necrosis. Devices and methods shown further provide fasteners with increased strength.

Abstract: Methods of injecting curable material within a bone structure, such as vertebroplasty, include locating a distal end of an access cannula within the bone structure. A channel creating device is inserted into a cannula lumen. A distal segment of the channel creating device is distally advanced from cannula distal end and into the bone structure. A curved channel is created in the bone structure with the distally advancing distal segment. A distal portion of a cavity creating device is then inserted into the cannula lumen, with the distal portion including an expandable body carried by an elongated body. The distal portion is distally advanced, following a path of the curved channel. The expandable body is transitioned to the expanded state to form a cavity in the bone structure. Finally, curable material is delivered to the cavity.

Abstract: A needle assembly 10 compromising an infusion needle 11 that includes a needle cannula 13 made of a superelastic material such as Nitinol. The needle cannula is cold-worked or heat annealed to produce a preformed bend 16 that can be straightened within passageway 21 of a coaxial outer cannula 12 for introduction into the body of a patient. Upon deployment from the outer cannula, the needle cannula substantially returns to the preformed configuration for the introduction or extraction of materials at areas lateral to the entry path of the needle assembly. The needle assembly can compromise a plurality of needle cannulae than can be variably arranged or configured for attaining a desired infusion pattern.

Abstract: A surgical apparatus includes an orientation sensor that detects an actual orientation of a surgical tool. The apparatus also includes an orientation feedback device that selectively provides an orientation feedback signal. Moreover, the apparatus includes a controller that causes the orientation feedback device to provide the orientation feedback signal when the actual orientation of the surgical tool detected by the orientation sensor is substantially equal to a predetermined target orientation of the surgical tool.

Abstract: A method and apparatus for forming any size antibiotic impregnated bone cement (AIBC) intramedullary (IM) nail. The cement nail is formed around a base support or base IM nail. The apparatus includes a molded plastic tube device to form the shape of the cement IM nail and plastic spacers which position the molded plastic tube around the base support or base IM nail for formation of the cement nail. The AIBC material may be any of the known antibiotic loaded/impregnated bone cements that are commercially available.

Abstract: Erosion of elements of the ossicular chain in the middle ear, resulting in hearing loss, is corrected by creating a bridge between the eroded elements, employing a bone cement formed as a paste of a self-hardening material, which is molded into an elongated bridge, secured at its two ends to the elements to be bridged, and supported in its desired position until the material hardens to fuse the two elements, at which time the support may be removed. The material is preferably hydroxyapatite cement, bone source, or similar material, such as ionomeric bone cement. These materials strongly bond to the contacting bone and may stimulate bone in-growth, resulting in osseointegration. The apparatus for forming the bridge consists of a reservoir of the bridge material in liquid or paste form connected to a bridge supporting tube. The tube is preferably placed in contact with the two elements to be bridged and the bone source material is injected into the tube using a manually actuated plunger until the tube is full.

Abstract: The present invention relates to a method of implanting a prosthesis device in a subject. In one embodiment, this method involves: (i) providing a prosthesis device to be attached to an exposed surface of a bone; (ii) applying bone cement in liquid form to a bone-implant interface region, the bone-implant interface region including a region between the exposed surface of the bone and an outer surface of the prosthesis device; and (iii) contacting the bone cement to the exposed surface of the bone and the outer surface of the prosthesis device under conditions effective to allow the bone cement to cure, thereby resulting in attachment of the prosthesis device to the bone of the subject. The present invention also relates to a kit for implanting a prosthesis device in a subject, a method of performing a joint arthroplasty surgical procedure, and other methods of using bone cement in liquid form.

Abstract: A method for preparing a de-aired hydraulic setting hardenable bone cement for filling a boney void or cavity by combining a powder bone substitute material and a aqueous liquid component, the method comprising the steps of: (a) supplying said powder bone substitute material in a first evacuable container; (b) withdrawing air from the first container to form a de-aired powder bone substitute material; and, then (c) mixing the de-aired powder bone substitute material and the aqueous liquid component together.

Abstract: Systems and methods for repairing a weakened or fractured bone are disclosed herein. A system for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen for passage of a mixing element; an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device moves from a first compact state to a second expanded state when the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device; and a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device.

Abstract: A bone repair apparatus includes a partially polymerized biocompatible adhesive provided in a state wherein polymerization of the biocompatible adhesive is substantially suspended. A method for repairing a bone defect includes preparing the biocompatible adhesive, suspending polymerization of the biocompatible adhesive prior to full cure, delivering the biocompatible adhesive to the bone defect while polymerization is substantially suspended and accelerating polymerization of the biocompatible adhesive to achieve full cure. The method provides an implanted biocompatible adhesive with a malleable osteoconductive structure without compromising the physical characteristics of the biocompatible adhesive, thereby improving handling and delivery of the bone adhesive.

Abstract: The application relates to a vacuum mixing device (1) for bone cement, where the monomer is pressed into a mixing container (2) due to the surrounding vacuum and a gas volume present in the monomer container (10).

Abstract: The invention relates to devices and kits for the controlled delivery of viscous, multi component compositions.

Abstract: This relates to an improved delivery system for accurately loading and controlling the delivery of flowable material to a patient. Particularly, the system may be used in the injection of hard tissue implant materials such as PMMA under pressures up to about 4000 psi. The system includes an applicator with a first column having an implant material introduction section adapted to provide for effective loading of the implant material and a second column housing a piston. The introduction section has a larger size than that of a vessel section or bore in which the requisite pressure seal between the piston and bore wall is formed. The first column may include an introduction section flared open to an included larger funnel-like opening or a separate funnel may be used that interfaces with the introduction section to facilitate the introduction of implant material.

Abstract: A needle assembly 10 compromising an infusion needle 11 that includes a needle cannula 13 made of a superelastic material such as Nitinol. The needle cannula is cold-worked or heat annealed to produce a preformed bend 16 that can be straightened within passageway 21 of a coaxial outer cannula 12 for introduction into the body of a patient. Upon deployment from the outer cannula, the needle cannula substantially returns to the preformed configuration for the introduction or extraction of materials at areas lateral to the entry path of the needle assembly. The needle assembly can compromise a plurality of needle cannulae than can be variably arranged or configured for attaining a desired infusion pattern.

Abstract: A surgical delivery system that has particular application for providing bone graft material to an interbody device that restores disc space height during spinal fusion surgery. The bone graft delivery system includes a body portion and a shaft coupled thereto. An auger extends through a bore in the shaft and into the body portion. An end of the shaft opposite to the body portion is configured to be coupled to the interbody device, where the auger extends through a channel in the interbody device. Bone graft material is placed in a hopper coupled to the shaft, where the auger is manually or automatically rotated to deliver the bone graft material through the shaft and into the interbody device where it is dispersed into the disc space.

Abstract: A bone adhesive application device has a pliable structure with an application surface upon which a bone adhesive may be applied. The application surface has a surface energy substantially equal to or less than a surface energy of the bone adhesive to reduce adhesion between the bone adhesive and the bone adhesive application device. The bone adhesive application device may be included in a kit for repairing bone defects having a bone adhesive formed from a reactive biocompatible polyurethane material. The bone adhesive may be applied to a bone defect by positioning the pliable structure over at least a portion of the bone defect, delivering the bone adhesive to the bone defect and removing the pliable structure from the bone adhesive.

Abstract: The invention encompasses compositions, methods, and kits, for fixing bone and/or repairing connective tissue associated with bone using a fenestrated bone screw. In certain embodiments, the invention encompasses a pedicle screw system including a bio-resorbable or implantable capsule containing cement and methods of use thereof for treating, preventing, and managing disorders in osteoporotic patients. In certain embodiments, the invention encompasses a fenestrated pedicle screw with cement containment skin that is useful in treating subjects in need of spine surgery due to neurologic deficit, deformity, or trauma, which subjects do not have sufficient time for the medical treatment of osteoporosis.

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: A medical assembly includes an implant and an envelope at least partially enclosing a portion of the implant. The envelope may include a tongue to protect the implant, a scaffold to provide integrity to the envelope, a tab access to ease envelope withdrawal, and/or one or more discontinuities to ease envelope withdrawal.

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: Disclosed herein are methods for treating a defect in a spinal disc nuclear space, comprising: (a) creating an opening by open, percutaneous or laparoscopic techniques to access the defect in the nuclear space; (b) removing a desired amount of tissue from the nuclear space; (c) positioning a delivery catheter through the opening; (d) fluidically isolating the nuclear space by blocking the opening with a blocking component of the catheter; (e) delivering an in-situ curable liquid material through a lumen of the catheter to the nuclear space; and (f) maintaining the isolating until the liquid material has cured. Also disclosed are treatment systems and materials for prostheses.

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: Systems and methods for repairing a weakened or fractured bone are disclosed herein. A system for repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of bone cement components and an inner lumen for passage of a mixing element; an internal bone fixation device releasably engaging the distal end of the delivery catheter, wherein the internal bone fixation device moves from a first compact state to a second expanded state when the bone cement components are delivered to the internal bone fixation device and mixed within the internal bone fixation device; and a spinning mechanism engaged to a rotatable shaft, wherein the spinning mechanism is inserted into the internal bone fixation device.

Abstract: A device for fixation of bone, and more particularly, a device for forming a cavity in bone using an expandable member, is provided. The device for fixation of bone includes an external tube, an internal tube placed inside the external tube such that a fluid passage is formed between the internal tube and the external tube, the internal tube having open portions on both ends, and an expandable member surrounding one end of the internal tube, and connected by one and the other ends to the external tube and the internal tube, respectively, the expandable member in fluid communication with the fluid passage.

Abstract: The present invention relates to a paste-powder binary bone cement used in arthroplasty or vertebroplasty, and, more particularly, to a paste-powder binary bone cement which can be directly used at a site to be treated without additionally waiting it to the site by dissolving predetermined chemically-unreactive powdered compositions in a liquid monomer to form paste having high viscosity and then mixing other powdered components with the paste in a minimum amount of air, and to an apparatus for injecting the same.

Abstract: Systems, devices, and methods achieve percutaneous fusion of the spine. The systems, devices, and methods percutaneously manipulate instrumentation to achieve posterior percutaneous transpedicular access to an interior of a first targeted vertebral body through a pedicle of the vertebra. The systems, devices, and methods percutaneously manipulate instrumentation through the achieved percutaneous transpedicular access, to achieve percutaneous cephalad trans-disc access to an interior of a second targeted vertebral body at a next adjacent superior level to the first targeted vertebral body. The systems, devices, and methods percutaneously manipulate instrumentation through the achieved percutaneous transpedicular access and percutaneous cephalad trans-disc access, to achieve percutaneous disc cavity creation comprising forming an enlarged cavity in the intervertebral disc space between the first and second targeted vertebral bodies.

Abstract: A method and devices for facilitating fixating and joining of bone fractures utilizing expandable devices that are positioned within the bone and across the fracture site. The stress from the expanded may enhance and expedite bone healing.

Abstract: An injector assembly for delivering flowable material to a medical implant, including a tube having a first end and a second end, a connector member and a port connector, where the connector member is coupled to the first end of the tube and the port connector is coupled to the second end of the tube, the connector member being configured to attach to a material delivery mechanism and the port connector being configured to attach to the medical implant. When the material delivery mechanism is actuated, the flowable material passes through the tube to the medical implant. A method of using an injector assembly to deliver a flowable material to a medical implant and bone surface is also described. A kit containing various sized parts for an injector assembly is also described.

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).