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 mixing and delivery system including a mixer, a delivery device, and a flexible extension tube. A connector is attached to a distal end of the flexible tube. The connector includes a housing, a fitting and an enlarged knob. A spindle that extends through the housing connects the fitting to the knob so the fitting rotates with the knob. A cannula is connected to the mixing and delivery system by placing the cannula fitting adjacent the connector fitting. The knob is rotated to result in the like rotation of the connector fitting. This causes the complementary threading on the connector fitting and the cannula fitting to engage.

Abstract: The invention relates to a biomaterial containing coagulated blood or coagulated bone marrow aspirate and biphasic calcium phosphate ceramic particles, to a production method thereof and to the use of same for the production of an implant that enables bone tissue regeneration.

Abstract: Implantable devices for fixation of curved bone such as the pelvic ring pubic symphysis and acetabulum, and methods for the use of the devices are disclosed. The implantable devices are convertible between a flexible state and a rigid state, and include an elongate structure having a proximal bone interface, a main body, and a distal bone interface. In a flexible state, the devices may be inserted along, and conform to a curved pathway, and in the rigid state, the devices may support the mechanical loads required to fixate a fracture.

Abstract: The present invention provides compositions of matter suitable for the prevention of and/or treatment of a spinal disorder and/or spinal pain, e.g., caused by and/or associated with intervertebral disc (IVD) degeneration, and methods of treatment of a spinal disorder and/or spinal pain. For example, the compositions of the present invention comprise a modulator of growth differentiation factor (GDF)-6 signaling sufficient to reduce or prevent or delay IVD degeneration and/or to enhance or induce IVD regeneration. The present invention also provides medical devices comprising such compositions, and methods of treatment making use of such compositions.

Abstract: A proximal humeral plate assembly can include a first plate, a coupler, a second plate, and a guide. The first plate can define a window and can have a first major surface adapted to conform to a native bone structure. The coupler can be formed on a second major surface of the first plate opposite the first major surface. The second plate can be adapted to engage the coupler, to cover the window, and to conform to the native bone structure. The second plate can include through holes adapted to receive bone screws. The guide can be adapted to engage the coupler and to guide at least one of a cutting tool and a dilation tool.

Abstract: Instruments for treating bone defects of the joint, particularly at the subchondral level, such as bone marrow lesions or bone marrow edema, are provided. In particular, these instruments may be delivery instruments that comprise features to control the location to which they deliver injectable materials or other tools to the bone to be treated. Also provided is an injection instrument that delivers a treatment material to the bone defect and stimulates a natural healing response in the bone.

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

Abstract: Systems and methods for treating vertebral compression fractures are provided. A kit can include at least one body containing a bone cement precursor to be mixed with at least one other bone cement precursor to form a bone cement. The body or a package containing the body can include at least one sensor. In some embodiments the sensor can be a temperature sensor. In some methods, data from the sensor can be used to determine certain parameters related to a treatment interval involving the bone cement.

Abstract: An apparatus for automated implantation of an implant or for an automated augmentation process of hard tissue and/or hard tissue replacement material using a sheath element is provided. The apparatus comprises a casing, a converter operable to generate mechanical vibrations the converter inside the casing and displaceable in a longitudinal direction relative to the casing, and a sonotrode coupled to an output location of the converter. A shaft portion with a retention structure is rotationally coupled to the casing and is equipped for cooperating with a rotationally asymmetric element of the sheath element to rotationally couple the casing to the sheath element. An axial coupling is equipped for locking the casing to the sheath element. The shaft portion, the axial coupling and the sonotrode are mutually arranged so that the a distal end of the sonotrode may be introduced into a longitudinal opening of the sheath element.

Abstract: An expandable member bone augmentation system and single-access-point 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. An expandable member such as, for example, a balloon can be used to create a plurality of voids by displacing bone material, where the voids can be filled with curable material to augment the bone.

Abstract: The invention provides a fusion device for use in spinal fusion procedures. The invention also provides systems and methods that include filling the fusion device with a cement composition.

Abstract: Systems and methods for treating vertebral compression fractures are discussed. In an embodiment, a method includes mixing bone cement precursors thereby causing a first chemical curing reaction characterized by a first time-viscosity profile, controllably applying energy to the bone cement from an external source to modify the first time-viscosity profile to a second time-viscosity profile, and injecting the cement into bone at a substantially constant viscosity greater than about 1000 Pa·s to greater than about 5000 Pa·s over an extended working time. In another embodiment, a bone cement injector system is provided that includes a first handle component that is detachably coupled to a second sleeve component having a distal end for positioning in bone and a flow channel extending through the first and second components. The system includes first and second thermal energy emitters for delivering energy to bone cement flows in a flow channel portion in the first and second components, respectively.

Abstract: System and methods are shown having a tube-within-tube assembly with a deployable curved deflectable tube or cannula that deploys from a straight cannula or trocar. The curved cannula has a pre-curved distal end to create an angular range of 0° to 180° when fully deployed from the straight trocar. The curve is configured such that the flexible element carrying a treatment device can navigate through the angular range of deployment of the curved cannula. The curved cannula allows the flexible element to navigate through a curve within bone without veering off towards an unintended direction.

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

Abstract: A method of treating a fracture includes creating an access path to a fracture site in a bone and inserting a guidewire through the access path into the fracture site is provided. The method includes the steps of positioning a cannulated drill bit having a distal end including helical flutes configured for drilling through bone over the guidewire into the fracture site, and advancing the drill bit to create a passageway in the bone configured to receive a screw. Positioning a cannulated inflatable bone tamp over the guidewire and inflating the inflatable bone tamp to compress at least a portion of the bone in or near the fracture site so as to create a void. Delivering a bone void filler into the void through the access path to fill the void. Systems and kits are disclosed.

Abstract: The present invention provides a device for bone fixation that includes: an expanding unit and an enclosing unit. The expanding unit includes two or more expanding structures capable of switching between an expanded state and a contracted state. The expanding unit includes a first expanding structure located near a first end thereof and a second expanding structure located near a second end thereof. The enclosing unit encloses the expanding unit and has a first end and a second end. The first end of the enclosing unit is secured at the first end of the expanding unit, and the second end of the enclosing unit is secured at the second end of the expanding unit. When the device for bone fixation is placed inside a bone, the expanding structures of the expanding unit are switched to the expanding state and thereby propping up the enclosing unit.

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

Abstract: A fixation system configured to releasably secure an orthopedic implant to a bone. The orthopedic implant has at least one lumen extending from a proximal portion to a distal portion configured to extend through cortical portions and into cancellous portions of the bone. The fixation system includes a flowable biomaterial that flows through the lumen into the cancellous portion of the bone in an expanded configuration with at least one dimension greater than a corresponding dimension on the orthopedic implant located generally along a pull-out direction of the orthopedic implant. An insert is positioned in the lumen and in engagement with the flowable biomaterial located in the cancellous portion of the bone, such that the orthopedic implant is detachable from the biomaterial in the cancellous portion of the bone to facilitate subsequent removal of the orthopedic implant from the bone.

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

Abstract: 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 cannulated and possibly fenestrated device for injection of material into bone can be dangerous because large, uncontrolled pressures are introduced during injection into a somewhat closed system, and material may extrude undesirably or emboli may be introduced. Methods and devices are described for providing venting of pressure upon injection of material through cannulated and possibly fenestrated screws. The first method involves a bone screw and/or anchor device that includes multiple channels to allow material to flow in through one channel and out through another channel. The second method involves a plunger that can force material into bone if advanced or lessen pressure if withdrawn. The third method involves usage of two separate screws. Material is alternately injected or withdrawn from each screw to cause material to flow from one screw to the other in a controlled way that creates a uniform or asymmetrical distribution of material as desired.

Abstract: A method of repairing a fractured articular bone at a fracture site has the steps of mixing a bone glue, inserting an expandable balloon into the fracture site, inflating the expandable balloon at the fracture site, applying the bone glue to the fracture site while the expandable balloon is inflated, curing the bone glue at the fracture site while the expandable balloon is inflated, deflating the expandable balloon after the bone glue has cured, and removing the deflated expandable balloon from the fracture site and from the articular bone. The bone glue combines a biologically dissolvable glue with an actual or artificial particulate bone graft.

Abstract: A fixation system configured to releasably secure an orthopedic implant to a bone. The fixation system including at least one expandable member that is inserted through the lumen and positioned in cancellous bone near the distal portion of the orthopedic implant. A delivery tube delivers a flowable biomaterial to the expandable member. The expand fixation structure includes at least one dimension greater than a corresponding dimension on the orthopedic implant to secure the orthopedic implant in the bone. An insert is secured in the lumen to releasably attach the fixation system to the orthopedic implant. The expandable member is detachable from the orthopedic implant to facilitate subsequent removal of the orthopedic implant from the bone.

Abstract: The embodiments provide devices and methods that both strengthen the bone and stimulate the bone. Bone fractures or non-unions are stabilized, integrated or healed, which results in reduction of a bone defect, such as a bone marrow lesion or edema. In addition, the distribution of forces in a joint are restored or altered to relieve pain. In general, a joint is evaluated by taking an image of the joint and one or more subchondral defects are detected. At least one of the subchondral defects may be diagnosed as the source of pain and an extent of treatment for the subchondral defect is determined. The disclosed devices and techniques are particularly suited for treating chronic defects or injuries, where the patient's natural healing response has not resolved the defect. The present disclosure also provides several exemplary treatment modalities for the different extents of treatment needed.

Abstract: A stand for use with a syringe is disclosed. The stand includes a base and a clip affixed to the base. The clip engages a portion of the syringe so as to removably secure the syringe to the stand in a position such that the distal end of the syringe is spaced vertically away from the base. Preferably, the syringe includes a handle extending outwardly from a barrel of the syringe, and the feature which the clip engages includes the handle of the syringe.

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 tamping apparatus is described that includes a cannula that has a tubular wall that includes a distal end portion that defines a tamping face. The cannula defines a longitudinally aligned aperture or lumen that provides access for an insert and the injection of treatment materials such as a bone graft. The distal end portion of the cannula can also include a plurality of movable elements that can be a part of or connected to the tubular wall. The tamp apparatus can also include a cannula or stylet that can be moved within aperture of cannula and is employed to move elements between the first position and second position of tamp apparatus.

Abstract: A minimally invasive system and method for vertebral body augmentation includes an expandable containment device, a chassis including an interior cavity for at least partially enclosing the expandable containment device, a first guidewire, a working cannula, a second guidewire having at least a partially flexible distal end portion and a sleeve for introducing bone filler material through a cannulated passageway of the sleeve and into an interior cavity of the containment device. The containment device preferably includes a plurality of pores for directing the outflow of bone filler material anteriorly within the vertebral body. The containment device and chassis are left interior to the vertebral body subsequent to height restoration and augmentation of the vertebral body.

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

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

Abstract: The kyphoplasty cement encapsulation balloon is a flexible, resilient silicone balloon having a catheter or filling tube disposed inside the balloon. The filling tube has a closed end and a plurality of orifices defined in the tube radially. The tube has an open mouth extending through a hole in the balloon, defining an inflation port. The inflation port is internally threaded, and preferably has a radiopaque marker band extending around the port. The inflation port has a one-way duck or duckbill valve that closes the inflation port when the inflation cannula is detached from the port, thereby encapsulating the bone cement in the balloon and preventing leakage of the cement. The inflation cannula and the kyphoplasty cement encapsulation balloon may be furnished as a kit.

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: Devices and methods in-situ produce articular spacers from a bone cement. The devices and methods have a punch surface for forming an articulation surface of a spacer in the bone cement, whereby the bone cement is arranged on a bone surface for fixation of the spacer, whereby the punch surface has a negative image of the articulation surface to be produced, and the surface forming the negative image is open on the side, at least in part, such that the bone cement can be pushed towards the side, away from the articulation surface to be formed. Moreover, the method for producing an articular spacer on a bone may have one or more of the following steps: A) Applying a bone cement to a prepared bone; B) Pressing said device onto the bone cement; and C) Detaching the device from the cured bone cement.

Abstract: A method for delivering a bisphosphonate and/or strontium ranelate below the surface of a bone using a mechanical force. The method includes the steps of combining a bisphosphonate and/or strontium ranelate with a carrier to form a delivery composition and delivering an effective amount of the delivery composition below the surface of the bone with a mechanical force. Also provided is a method for strengthening a portion of a bone. This method includes the step of delivering an effective amount of a bisphosphonate and/or strontium ranelate below the surface of a portion of a bone with a mechanical force.

Abstract: An ultrasonic handpiece is used for augmenting a bone screw. The handpieces comprise a housing, an ultrasonic converter shiftingly accommodated in the housing, and a sonotrode connected to one end of the ultrasonic converter. The sonotrode protrudes from the housing into the bone screw. An adjuster wheel is adjustably connected to the housing. A spring is provided the ends of which are supported by the ultrasonic converter and the adjuster wheel, respectively. The ultrasonic converter is preloaded in the direction away from the adjuster wheel by setting the adjuster wheel, thereby the sonotrode is urged with a selected force into the bone screw and the augmentation material is pressed out of the bone screw and into the bone.

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

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

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

Abstract: A medical balloon device includes an outer member extending along an axis. An inflatable member has a proximal end extending from a first end of the outer member and a distal end. An inner member is positioned within the outer member and the inflatable member such that a first end of the inner member is coupled to the distal end of the inflatable member. A support member is movably disposed within the inner member and includes a first end configured to removably engage the first end of the inner member. Translation of the support member along the axis causes the inflatable member to move between a first position in which the inflatable member has a first length and a first profile and a second position in which the inflatable member has a second reduced length and a second reduced profile. Methods of use are disclosed.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. The distal end may be provided with 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: The embodiments provide provides devices, instruments, and associated methods for treating joint pain. A joint is evaluated using magnetic resonance imaging to detect any defects in the subchondral bone. For example, using T2-weighted MRI images, bone marrow lesions or edemas can be identified, and using T1-weighted MRI images, associated regions of sclerotic bone adjacent to the bone marrow lesion can be identified. The treatment method may involve introducing a bone void filler material at the site to address the bone marrow lesion or edema, and/or drilling and inserting an implant to address the sclerotic bone, bone marrow lesion or edema, and insufficiency or stress fractures. An access path is mapped to a location in the subchondral region where the insufficiency fracture resides. The access path attempts to preserve an articular surface of the joint. A reinforcing member that stabilizes the insufficiency fracture is then implanted via the access path.

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: Implantable devices for the surgical treatment of bone, and particularly to a bone defect at a joint region, and even more particularly at the subchondral bone level of the joint region, are disclosed. The implantable devices may be formed of a bone material, and configured to serve the dual functions of providing mechanical strength and structural integrity to the area to be treated, while also facilitating the dispersal of a flowable material in the same area. Associated delivery tools are also provided.

Abstract: The equipment for removing cement from bone cavities consists of an elongated body, hollow inside, that can be inserted inside a cement-filled bone cavity, and at least one rod for extracting the elongated body buried in the cement, that can be inserted inside the elongated body. The elongated body comprises a plurality of rigid elements aligned with each other and associated to one another by the interposition of spacer elements, tubular in shape and coaxial to the elongated body, the rigid elements including removable means for connecting to the extraction rod which are arranged inside the elongated body.

Abstract: A tissue repair device. The tissue repair device includes a tubular shaft having a longitudinal bore for delivering biological material to a soft tissue defect, and an awl having a distal end configured for microfracturing bone underlying the defect. The tubular shaft and the awl are movable relative to one another such that the awl is at least partially positioned within the longitudinal bore of the tubular shaft.

Abstract: A device (10) for mixing and dispensing bone cement includes a mixing cylinder (20), in which a mixing plunger (21) is arranged, the mixing plunger (21) being axially movable by an actuation rod (50) guided out in a sealed manner at a first cylinder end (30). A sealing plunger (42) is arranged in a region of the first cylinder end (30), is axially movable on the actuation rod (50) and seals the mixing cylinder (20) in a gas-tight manner. A sterilization plunger (41) is arranged in the region of the first cylinder end (30) between the mixing plunger (21) and the sealing plunger (42), is axially movable on the actuation rod (50) separately from the sealing plunger (42), and seals the mixing cylinder (20) in a gas-permeable manner. The sterilization plunger (41) and the sealing plunger (42) form a two-part plunger system (40).

Abstract: The present invention relates invention relates to devices and methods for the fixation and stabilization of orthopedic fractures and more specifically to stabilization of compression fractures of spinal vertebrae. The systems comprise cannulated orthopedic screws and mechanical expandable implants introducible through the lumen of such screws. In certain embodiments the cannulated implants are expandable within an intraosseous space to introduce scaffold-like structures such that subsequent introduction of a bone cement forms a composite in situ. The devices and methods are also particularly useful for stabilizing the orthopedic screws.

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