Abstract: Systems for off-axis a vertebral body. A steerable assembly includes a steering instrument, a steering handle, and a trigger. A deflectable portion of the steering instrument and a distal portion of a deformable conduit are configured to be directed through and beyond the access cannula. A control surface of the trigger is configured to receive a pull or squeeze input to pivot the trigger to move the steering instrument to an operating mode in which increased tension on the steering instrument curves the deflectable portion of the steering instrument and the distal portion of the deformable conduit. A mounting block may be fixed within the steering handle, and a proximal end of the shaft may be fixed to the mounting block. The steering handle includes a guide movably supported within a void and coupled to the control element. A rear surface of the trigger engages the guide.

Abstract: Systems and methods for augmenting a vertebral body. An introducer device includes a shaft having a flexible distal portion with a pre-set curve in an unconstrained state. An input provided to an actuator to tension a pulling element to move the pre-set curve to a constrained state in which the distal portion and a flexible sheath conforming to the shaft at least partially straighten. The introducer device is removable from the sheath remaining offset from a longitudinal axis. A spacer hub facilitates proximal movement of the sheath relative to an access cannula expose a balloon through a syringe-style input. A hub of the access cannula may be adjustable to selectively adjust an interference surface relative to a datum. At least two radiopaque markers may be disposed on the sheath with relative positions between the markers viewable on lateral and A-P radiography to determine the location and/or curvature of the sheath.

Abstract: Systems for augmenting a vertebral body. A deformable conduit assembly includes a hub defining an opening, and a deformable conduit within which a steering instrument is removably disposed. The deformable conduit may be curved by the steering instrument. An expandable member assembly includes a catheter tube slidably positioned through the opening of the hub and a cannula handle of an access cannula, and an expandable structure. The deformable conduit may be moved proximally relative to the hub and the expandable member assembly to expose the expandable structure within the vertebral body. The hub may define one or more guiding slots though which one or more arms are slidably positioned. An axial controller may be coupled to a proximal end of the deformable conduit. The axial controller is configured to receive an input to expose the expandable structure by moving the deformable conduit relative to the hub and the access cannula.

Abstract: Systems and methods for augmenting a vertebral body. An introducer device includes a shaft having a flexible distal portion with a pre-set curve in an unconstrained state. An input provided to an actuator to tension a pulling element to move the pre-set curve to a constrained state in which the distal portion and a flexible sheath conforming to the shaft at least partially straighten. The introducer device is removable from the sheath remaining offset from a longitudinal axis. A spacer hub facilitates proximal movement of the sheath relative to an access cannula expose a balloon through a syringe-style input. A hub of the access cannula may be adjustable to selectively adjust an interference surface relative to a datum. At least two radiopaque markers may be disposed on the sheath with relative positions between the markers viewable on lateral and A-P radiography to determine the location and/or curvature of the sheath.

Abstract: Systems and methods for augmenting a vertebral body. The system includes an access cannula, an introducer device, a sheath device, and a treatment device. The introducer device may be moved from unconstrained state to a constrained state in which a pulling element is tensioned. The access cannula may initially prevent the shaft sheath from assuming a curve, after which the introducer device and the sheath device may be advanced relative to the access cannula to assume the curve within the vertebral body. An actuator of the introducer device may include a resilient arm configured to resiliently deflect such that a lock head releasably engages a feature of a handle of the introducer device. A spacer lock facilitates proximal movement of the sheath relative to the access cannula so as to expose the treatment device within the vertebral body at a location offset from a longitudinal axis of the access cannula.

Abstract: A mixing device and methods for making bone cement. A piston (156) of the mixing device is located in a first region (158) of a chamber (112) such that a mixing paddle (154) rotates to mix bone cement components at a first pressure to make a bone cement mixture. The piston (156) is moved passed an inlet opening (136) to be located within a second region (160) of the chamber (112) to compress the bone cement mixture to a second pressure greater than the first pressure to compress the bone cement mixture and make the bone cement. The bone cement may be transferred to a delivery device. The mixing device may include features that automatically initiate the compression and transferring phases after completion of the mixing phase, and further include features that automatically terminate the operational cycle. A three-step intuitive workflow utilizing the mixing device to improve efficiency in the surgical suite is also disclosed.

Abstract: Systems and methods for augmenting a vertebral body. An introducer device includes a shaft having a flexible distal portion with a pre-set curve in an unconstrained state. An input provided to an actuator to tension a pulling element to move the pre-set curve to a constrained state in which the distal portion and a flexible sheath conforming to the shaft at least partially straighten. The introducer device is removable from the sheath remaining off-set from a longitudinal axis. A spacer hub facilitates proximal movement of the sheath relative to an access cannula expose a balloon through a syringe-style input. A hub of the access cannula may be adjustable to selectively adjust an interference surface relative to a datum. At least two radiopaque markers may be disposed on the sheath with relative positions between the markers viewable on lateral and A-P radiography to determine the location and/or curvature of the sheath.

Abstract: A device for creating a cavity or a channel in bone. First and second steering cables are coupled to a flexible elbow or a tip of a shaft. A control assembly is operably coupled to the first and second steering cables and configured to tension one of the steering cables and slacken another one of the steering cables so as to flex the flexible elbow. The control assembly may include a steering block axially movable within a handle with a knob threadably coupled to the steering block. The steering block may be rotatably fixed within the handle. The first and second steering cables may be anchored to the steering block, such as to opposite sides of the steering block. The first steering cable may extend along a linear path, and the second steering cable may extend along a curved rib of the handle.

Abstract: Systems for augmenting a vertebral body. A deformable conduit assembly includes a hub defining an opening, and a deformable conduit within which a steering instrument is removably disposed. The deformable conduit may be curved by the steering instrument. An expandable member assembly includes a catheter tube slidably positioned through the opening of the hub and a cannula handle of an access cannula, and an expandable structure. The deformable conduit may be moved proximally relative to the hub and the expandable member assembly to expose the expandable structure within the vertebral body. The hub may define one or more guiding slots though which one or more arms are slidably positioned. An axial controller may be coupled to a proximal end of the deformable conduit. The axial controller is configured to receive an input to expose the expandable structure by moving the deformable conduit relative to the hub and the access cannula.

Abstract: Systems and methods for augmenting a vertebral body may include an optional access cannula, introducer device, and a stylet having a stylet shaft. The access cannula includes a hub portion and a cannula shaft extending from the cannula hub. The cannula shaft includes a distal end positionable within the vertebral body that defines a lumen along a longitudinal axis. The introducer device may be a telescoping or pivoting introducer device that is removably coupled to the hub portion of the access cannula. The introducer device controls the movement of the flexible distal portion of the stylet shaft and the flexible sheath from within the introducer device through the access cannula to within a target site in the vertebral body, wherein the flexible distal portion is moved from the constrained to the unconstrained state to displace cancellous bone within the target site.

Abstract: A system including a flow diverter for delivering bone cement. A cannula coupler is coupled to the flow diverter and configured to be coupled to a delivery cannula. A drool accumulator is coupled to the flow diverter. A user input mechanism is coupled to the flow diverter and configured to actuate a valve and establish fluid communication between the cement reservoir and one of the cannula coupler and the drool accumulator. The fluid communication may be interrupted between the cement reservoir and the other one of the cannula coupler and the drool accumulator. A cement delivery input mechanism may be coupled to the cement reservoir and configured to be actuated to direct the bone cement from the cement reservoir towards the flow diverter. An actuator may be coupled to the drool accumulator and configured to direct the bone cement received in the drool volume towards the flow diverter.

Abstract: Methods of manipulating cancellous bone within a vertebral body. A steerable assembly is directed through an access cannula such that a deflectable portion of the steerable assembly protrudes from the access cannula to within the vertebral body. The steering instrument is actuated from an operating tension mode in which a tension is placed on the control element of the steering instrument to a slack tension mode in which the tension on the control element is released. The steerable instrument may exert substantially zero lateral force on the deformable conduit in the slack tension mode. The steering instrument is moved relative to the deformable conduit positioned within the vertebral body. The steering instrument is actuated to move the steering instrument from the slack tension mode to the operating tension mode in which the deflectable portion may assume a curved configuration not substantially coaxial with a longitudinal axis of the access cannula.

Abstract: A bone cement delivery system includes a plunger configured to selectively displace bone cement from a cement reservoir through an exit port. Additionally, the system includes a flow diverter comprising a diverter inlet, a first diverter outlet, and a second diverter outlet. The system also includes a cannula coupler configured for connection to a delivery cannula for directing the bone cement to a target site, and a drool accumulator defining a drool volume for receiving residual bone cement. The flow diverter includes a valve arranged for selective movement between a first configuration where fluid communication is established between the cement reservoir and the drool volume; and where fluid communication is interrupted between the cement reservoir and the cannula coupler; and a second configuration where fluid communication is established between the cement reservoir and the cannula coupler; and where fluid communication is interrupted between the cement reservoir and the drool volume.

Abstract: Systems and methods for augmenting a vertebral body may include an optional access cannula, introducer device, and a stylet having a stylet shaft. The access cannula includes a hub portion and a cannula shaft extending from the cannula hub. The cannula shaft includes a distal end positionable within the vertebral body that defines a lumen along a longitudinal axis. The introducer device may be a telescoping or pivoting introducer device that is removably coupled to the hub portion of the access cannula. The introducer device controls the movement of the flexible distal portion of the stylet shaft and the flexible sheath from within the introducer device through the access cannula to within a target site in the vertebral body, wherein the flexible distal portion is moved from the constrained to the unconstrained state to displace cancellous bone within the target site.

Abstract: A bone cement delivery system includes a plunger configured to selectively displace bone cement from a cement reservoir through an exit port. Additionally, the system includes a flow diverter comprising a diverter inlet, a first diverter outlet, and a second diverter outlet. The system also includes a cannula coupler configured for connection to a delivery cannula for directing the bone cement to a target site, and a drool accumulator defining a drool volume for receiving residual bone cement. The flow diverter includes a valve arranged for selective movement between a first configuration where fluid communication is established between the cement reservoir and the drool volume; and where fluid communication is interrupted between the cement reservoir and the cannula coupler; and a second configuration where fluid communication is established between the cement reservoir and the cannula coupler; and where fluid communication is interrupted between the cement reservoir and the drool volume.

Abstract: A surgical system for manipulating tissue. A steerable instrument is at least partially disposed in a deformable conduit. The steering instrument may include a control element and a deflectable portion operatively connected to the control element. The steerable instrument is actuatable to move between at least a substantially straight configuration and a curved configuration when the deflectable portion protrudes from an access cannula positioned within the tissue. The deflectable portion of the steerable instrument moves away from a longitudinal axis of the access cannula in order to deform the deformable conduit so that the deformable conduit occupies a deformed position. The steering instrument is removable from the deformable conduit so as to allow withdrawal of the deflectable portion of the steerable instrument from the deformable conduit without substantially displacing the deformed position of the deformable conduit. Methods of manipulating tissue with the surgical system are also disclosed.

Abstract: Methods of manipulating cancellous bone within a vertebral body. A steerable assembly is directed through an access cannula such that a deflectable portion of the steerable assembly protrudes from the access cannula to within the vertebral body. The steering instrument is actuated from an operating tension mode in which a tension is placed on the control element of the steering instrument to a slack tension mode in which the tension on the control element is released. The steerable instrument may exert substantially zero lateral force on the deformable conduit in the slack tension mode. The steering instrument is moved relative to the deformable conduit positioned within the vertebral body. The steering instrument is actuated to move the steering instrument from the slack tension mode to the operating tension mode in which the deflectable portion may assume a curved configuration not substantially coaxial with a longitudinal axis of the access cannula.

Abstract: A surgical system for manipulating tissue. A steerable instrument is at least partially disposed in a deformable conduit. The steering instrument may include a control element and a deflectable portion operatively connected to the control element. The steerable instrument is actuatable to move between at least a substantially straight configuration and a curved configuration when the deflectable portion protrudes from an access cannula positioned within the tissue. The deflectable portion of the steerable instrument moves away from a longitudinal axis of the access cannula in order to deform the deformable conduit so that the deformable conduit occupies a deformed position. The steering instrument is removable from the deformable conduit so as to allow withdrawal of the deflectable portion of the steerable instrument from the deformable conduit without substantially displacing the deformed position of the deformable conduit. Methods of manipulating tissue with the surgical system are also disclosed.

Abstract: A surgical system and method for manipulating tissue. A steerable assembly comprises a steerable instrument and a deformable conduit. The steerable instrument comprises a control element and a deflectable portion operatively connected to the control element. The steerable assembly is directed through an access cannula such that at least a portion of the steerable assembly protrudes from the distal end of the access cannula. The steerable instrument is actuated to move a deflectable portion of the steerable instrument and a distal portion of the deformable conduit away from the longitudinal axis of the access cannula so that the deformable conduit assumes a deformed position. The steerable instrument is retracted from the deformable conduit.

Abstract: A surgical system and method for manipulating tissue. A steerable assembly comprises a steerable instrument and a deformable conduit. The steerable instrument comprises a control element and a deflectable portion operatively connected to the control element. The steerable assembly is directed through an access cannula such that at least a portion of the steerable assembly protrudes from the distal end of the access cannula. The steerable instrument is actuated to move a deflectable portion of the steerable instrument and a distal portion of the deformable conduit away from the longitudinal axis of the access cannula so that the deformable conduit assumes a deformed position. The steerable instrument is retracted from the deformable conduit.