Patent Description:
One treatment modality includes vertebral augmentation in which the height of the vertebral body is elevated or restored, and stabilized at the elevated or restored height. A vertebroplasty includes delivering curable material, for example a bone cement, within an interior of the vertebral body. The material interdigitates with cancellous bone and cures to stabilize the vertebral body. A kyphoplasty includes creating a cavity within the interior of the vertebral body by compressing the cancellous bone with an expandable member such as a balloon, and delivering the curable material into the cavity. The expandable member may facilitate elevating or restoring the height of the vertebral body.

Accessing the interior of the vertebral body often includes percutaneously placing an access cannula through a pedicle of the vertebra. Owing to the structure of the vertebra, accessing a location on the contralateral side of the vertebral body is not especially feasible with straight instrumentation. As such, one existing kyphoplasty technique employs a bipedicular approach in which two access cannulas are placed, followed by two balloons each positioned ipsilaterally within the interior of the vertebral body. The bipedicular approach undesirably requires twice the trauma to tissue, and often requires twice the instrumentation.

Of particular interest is a unipedicular approach in which the instrumentation is designed to access locations of the interior of the vertebral body offset from a longitudinal axis of the access cannula, including locations on the contralateral side of the vertebral body. One exemplary system utilizing the unipedicular approach is disclosed in commonly owned <CIT>, and sold under the tradename Avaflex by Stryker Corporation (Kalamazoo, Mich. While the disclosure realizes the benefits of the unipedicular approach, there is further need in the art for systems and methods for off-axis vertebral augmentation.

Document <CIT> describes methods and devices that displace bone or other hard tissue to create a cavity in the tissue. Such methods and devices rely on a driving mechanism for providing moving of the device to from a profile that improves displacement of the tissue. These methods and devices also allow for creating a path or cavity in bone for insertion of bone cement or other filler to treat a fracture or other condition in the bone. The features relating to the methods and devices can be applied in any region of bone or hard tissue where the tissue or bone is displaced to define a bore or cavity instead of being extracted from the body such as during a drilling or ablation procedure.

Claim <NUM> is directed to a system for augmenting a vertebral body. The system includes an access cannula, and introducer device, and a flexible sheath. The access cannula includes a cannula hub, and a cannula shaft extending from the cannula hub. The cannula shaft includes a distal end positionable within the vertebral body and defining a lumen along a longitudinal axis. The introducer device includes an actuator configured to receive an input from a user, and a shaft. The shaft includes a rigid proximal portion coupled to the actuator and defining a proximal end of the shaft, and a flexible distal portion. A length of the shaft between the proximal end and a distal end is sufficient for the shaft to extend through and be operable beyond the distal end of the access cannula. The flexible distal portion includes a pre-set curve in an unconstrained state. The introducer device includes a pulling element coupled to the actuator and to the shaft at or near the distal end. The pulling element extends along at least a portion of the pre-set curve. A distal portion of said flexible sheath is configured to conform to said flexible distal portion as said pre-set curve is moved between said constrained state and said unconstrained state. According to claim <NUM>, tension on the pulling element is configured to be increased in response to the input provided to the actuator to move the pre-set curve from the unconstrained state to a constrained state in which the flexible distal portion at least partially straightens. In further accordance with claim <NUM>, the tension on the pulling element is configured to be reduced to facilitate the pre-set curve moving from the constrained state to the unconstrained state to position the distal end of the shaft within the vertebral body at a target site that is offset from the longitudinal axis. The flexible sheath of the system of claim <NUM> at least partially overlying the shaft with the flexible sheath including a distal end positionable near the distal end of the shaft such that the flexible sheath is configured to extend through and be operable beyond the distal end of the access cannula with a distal portion of the flexible sheath conforming to the flexible distal portion as the pre-set curve moves between the constrained state and the unconstrained state, wherein the introducer device is removable from the flexible sheath with the distal end of the flexible sheath remaining at the target site offset from the longitudinal axis.

In some implementations of the system of claim <NUM>, the pre-set curve defines an inner curved surface opposite an outer curved surface. The pulling element may extend along at least a portion of the outer curved surface. The introducer device may include a housing, and a locking mechanism operably coupling the housing and the actuator, wherein the locking mechanism is configured to permit selective locking of the actuator in one of a plurality of positions.

In some implementations of the system of claim <NUM>, the system includes an expandable member assembly including a balloon hub, a balloon tube extending from the balloon hub, and a balloon coupled to a distal end of the balloon tube. The balloon hub is adapted to be coupled to a fluid source. The balloon tube may be sized to be slidably inserted within the flexible sheath. The balloon may be configured to be inflated with fluid from the fluid source to displace cancellous bone within the vertebral body. The balloon tube has a length such that the balloon is positioned proximate the distal end of the flexible sheath when the balloon tube is slidably inserted within the flexible sheath.

An exemplary aspect of the disclosure involves a method of operating the system according to the first example (the method is described herein to aid understanding the invention, but not claimed), and optionally, any of its corresponding implementations.

An exemplary further aspect of the present disclosure is directed to a system for augmenting a vertebral body. The system includes an access cannula, a delivery cannula, an expandable member assembly, and a spacer hub. The access cannula includes a cannula hub, and a cannula shaft extending from the cannula hub. The cannula shaft includes a distal end positionable within the vertebral body. The delivery cannula includes a delivery hub, and a sheath extending from the delivery hub. The sheath includes a distal end opposite a proximal end collectively defining a length sufficient to extend through and be operable beyond the distal end of the access cannula. The delivery hub is movable relative to the cannula hub such that the sheath is slidably disposed within the cannula shaft. The expandable member assembly includes a balloon hub adapted to be coupled to a fluid source. A balloon tube extends from the balloon hub and is sized to be slidably inserted within the sheath. A balloon is coupled to a distal end of the balloon tube and configured to be inflated with fluid from the fluid source to displace cancellous bone within the vertebral body. The spacer hub is configured to facilitate proximal movement of the delivery cannula relative to the access cannula and the expandable member assembly. The sheath is retracted to expose the balloon within the vertebral body through a syringe-style input from a user. The spacer hub includes a distal portion engaging the cannula hub and a proximal portion for engaging the balloon hub. The distal and proximal portions include opposing stop surfaces defining a void space with the delivery hub configured to be movably disposed within the void space such that the opposing stop surfaces provide a terminus of movement of the delivery hub.

In some implementations, the system includes a biasing element operably coupled to the pulling element and the actuator. The biasing element may be configured to be at least initially in a stressed state to bias the pulling element to the constrained state. The biasing element may be further configured to relax in response to the input to provided to the actuator to facilitate altering the tension on the pulling element to permit the flexible distal portion to move to the unconstrained state.

An exemplary further aspect of the disclosure is directed to a system for augmenting a vertebral body. The system includes an access cannula, a delivery cannula, an expandable member assembly, and a spacer hub. The access cannula includes a cannula hub, and a cannula shaft extending from the cannula hub. The cannula shaft includes a distal end positionable within the vertebral body. The delivery cannula includes a delivery hub, and a sheath extending from the delivery hub. The sheath includes a distal end opposite a proximal end collectively defining a length sufficient to extend through and be operable beyond the distal end of the access cannula. The delivery hub is movable relative to the cannula hub such that the sheath is slidably disposed within the cannula shaft. The expandable member assembly includes a balloon hub adapted to be coupled to a fluid source. A balloon tube extends from the balloon hub and sized to be slidably inserted within the sheath. A balloon is coupled to a distal end of the balloon tube and configured to be inflated with fluid from the fluid source to displace cancellous bone within the vertebral body. The spacer hub is configured to facilitate proximal movement of the delivery cannula relative to the access cannula and the expandable member assembly. The sheath is retracted to expose the balloon within the vertebral body through a syringe-style input from a user. The spacer hub includes a distal portion engaging the cannula hub, a proximal portion configured to engage the balloon hub, and a pivot pivotably coupling the distal portion to the proximal portion.

In some implementations, the balloon hub includes a body portion, a transition surface configured to engage the proximal portion of the spacer hub, and a control surface opposite the transition surface and sized to receive a thumb of the user to facilitate providing the syringe-style input. The delivery hub may define a lumen and each of the distal and proximal portions of the spacer hubs define coaxial apertures. At least a portion of the balloon tube may extend through the lumen and the coaxial apertures such that the delivery hub is slidable along the balloon tube between the distal and proximal portions of the spacer hub. At least one side may extend between the distal and proximal portions. The side(s) may be two sides defining opposed slots extending between the distal and proximal portions. The delivery hub comprises wings extending through the opposed slots and configured to receive the syringe-style input from the user.

In some implementations, the spacer hub includes a pivot pivotably coupling the distal portion and the proximal portion. The delivery hub may include a coupler defining an opening in communication with the sheath, wherein pivoting the proximal portion relative to the distal portion exposes the coupler for removably coupling a cement delivery system with the coupler.

In some implementations, the spacer hub is configured to be operable with the system according to the first aspect of the present disclosure, and optionally, any of its corresponding implementations.

An exemplary further aspect of the disclosure involves a method of operating the system according to the third example (the method is described herein to aid understanding the invention, but not claimed), and optionally, any of its corresponding implementations.

An exemplary further aspect of the disclosure is directed to a system for augmenting a vertebral body. The system includes an access cannula and an instrument. The access cannula includes a cannula shaft includes a distal end positionable within the vertebral body that defines a lumen along a longitudinal axis. A cannula hub includes a shaft hub rigidly coupled to the cannula shaft, and a tuning hub movably coupled to the shaft hub. The shaft hub is at a fixed distance from the vertebral body when the distal end of the cannula shaft is positioned within the vertebral body to provide a datum. The tuning hub includes an interference surface movable relative to the shaft hub between plurality of supported positions. The instrument includes an elongate member slidably disposed within the lumen of the cannula shaft and includes a length defined between proximal and distal ends being sufficient for the elongate member to extend through and be operable beyond the distal end of the access cannula. An instrument hub is coupled to the proximal end of the elongate member. The cannula hub is configured to be engaged by the instrument hub to prevent distal movement of the instrument relative to the access cannula while permitting proximal movement of the instrument relative to the access cannula. The movement of the tuning hub relative to the shaft hub to one of the plurality of supported positions facilitates selective adjustment of an axial position of the interference surface of the tuning hub relative to the datum.

In some implementations, each of the shaft hub and the tuning hub may include complementary threading for permitting the selective adjustment of the interference surface through a twisting input from the user. Each of the shaft hub and the tuning hub may define apertures coaxially aligned with the lumen with at least one of the instrument hub and the elongate member extending through the coaxial apertures. The instrument may be one of an introducer device, a delivery cannula, and an expandable member assembly.

In some implementations, the instrument hub is configured to be operable with the systems according to the first and third aspects of the present disclosure, and optionally, any of their corresponding implementations.

An exemplary further aspect of the disclosure is directed to a method of operating the system according to the fifth example (the method is described herein to aid understanding the invention, but not claimed), and optionally, any of its corresponding implementations.

In some implementations of claim <NUM>, at least two radiopaque markers are disposed on the distal portion of the flexible sheath and spaced apart from one another. As the distal portion is curved within the vertebral body, relative positions between the at least two radiopaque markers are viewable on radiography to determine a curvature of the curve.

In some implementations the radiopaque markers are exactly two radiopaque markers. The radiopaque markers may be one of dots, bands, rings, and lines.

In some implementations, the radiopaque markers are configured to be operable with the systems according to the first, third, fifth and seventh aspects of the present disclosure, and optionally, any of their corresponding implementations.

Another exemplary aspect of the disclosure is directed to a method of operating the system according to the seventh example (the method is described herein to aid understanding the invention, but not claimed), and optionally, any of its corresponding implementations.

Advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings.

<FIG> shows a system <NUM> for augmenting a vertebral body. An illustration of an axial section of a vertebra (V) is shown with certain structures and regions to be referenced throughout the present disclosure. The vertebra (V) includes pedicles (P) on opposing lateral sides of a spinal canal (SC) that provide a generally linear path from a posterior approach to an interior (I) region of the vertebral body (VB). The vertebral body (VB) includes a cortical rim (CR) formed from cortical bone that at least partially defines the interior (I) region. A volume of cancellous bone (CB) is within the interior (I) region. With reference to the compass rose of <FIG>, the anatomical directions may also be referenced in accordance with standard medical convention; i.e., medial (M) to the center of the body, lateral (L) to the sides of the body, anterior (A) to the front of the body, and posterior (P) to the rear of the body.

The system <NUM> includes an introducer device <NUM> and an access cannula <NUM>. The access cannula <NUM> includes a cannula hub <NUM>, and a cannula shaft <NUM> extending from the cannula hub <NUM>. The cannula shaft <NUM> includes a proximal end <NUM> coupled to the cannula hub <NUM>, and a distal end <NUM> opposite the proximal end <NUM>. The cannula shaft <NUM> may be straight and define a lumen (not identified) extending between the proximal and distal ends <NUM>, <NUM> such that the cannula shaft <NUM> is tubular in shape. The cannula shaft <NUM> may be formed from biocompatible materials with sufficient mechanical properties to maintain integrity as the cannula shaft <NUM> is driven through the pedicle of the vertebra. The system <NUM> may include a trocar (not shown) removably positioned within the cannula shaft <NUM> during placement of the distal end <NUM> of the cannula shaft <NUM> into the vertebral body. The trocar may include a length slightly greater than a length of the cannula shaft <NUM> such that a sharp tip of the trocar pierces the cortical bone of the cortical rim, and the trocar prevents coring of tissue within the lumen of the cannula shaft <NUM>. Once the distal end <NUM> of the cannula shaft <NUM> is positioned within the vertebral body, for example as shown in <FIG>, the trocar is removed. The access cannula <NUM> provides a working channel to within the interior region of the vertebral body along a longitudinal axis (LA) defined by the cannula shaft <NUM>. The cannula hub <NUM> is exposed above the tissue overlying the vertebra, and configured to be engaged by the introducer device <NUM>.

With further reference to <FIG> and <FIG>, the introducer device <NUM> includes an actuator <NUM>. The actuator <NUM> is configured to receive an input from a practitioner or user to actuate the introducer device <NUM> in a manner to be further described. The actuator <NUM> includes a housing <NUM>, and a control surface <NUM> movably coupled to the housing <NUM>. <FIG> show the housing <NUM> and the control surface <NUM> in a "pistol-grip" arrangement in which a handle <NUM> of the housing <NUM> is configured to rest in a palm of a hand of the practitioner, and the control surface <NUM> configured to be pulled towards or released away from the handle <NUM> with one or more fingers of the hand of the practitioner. Other arrangements of the actuator <NUM> are contemplated, for example a rotary knob disclosed in commonly owned <CIT>. The housing <NUM> also includes a frame <NUM> coupled to the handle <NUM>. <FIG> show the frame <NUM> integrally formed with the handle <NUM> in a generally L-shaped arrangement. The housing <NUM> may be formed from mirrored housing shells <NUM>, <NUM> joined together, which be manufactured from polymers, metals, composites, and combinations thereof. For example, each of the housing shells <NUM>, <NUM> may be injection molded so as to be low cost and disposable after a single use. The housing shells <NUM>, <NUM> may at least partially define an interior of the housing <NUM> sized and shaped to accommodate several components of the actuator <NUM> to be described.

The housing <NUM> may further include a barrel <NUM> extending distal to (or forward of) the frame <NUM>. As used herein, distal or distally refers to a direction away from the practitioner, and proximal or proximally refers to a direction towards the practitioner. The barrel <NUM> defines a bore in communication with the interior of the housing <NUM>. A distal end <NUM> of the barrel <NUM> may define a distal end of the actuator <NUM>, and a proximal end <NUM> of the barrel <NUM> may be defined by a transition surface <NUM> extending radially from the barrel <NUM>. <FIG> and <FIG> show the barrel <NUM> being cylindrical in shape between the proximal and distal ends <NUM>, <NUM> and having an outer diameter sized to be slidably and removably inserted through a proximal portion <NUM> of a spacer hub <NUM> to be described. With the transition surface <NUM> engaging the proximal portion <NUM> of the spacer hub <NUM>, as best shown in <FIG>, a length of the barrel <NUM> defined between the proximal and distal ends <NUM>, <NUM> may be sufficient to engage or abut a coupler <NUM> of a delivery cannula <NUM>. The engagement of the distal end <NUM> of the barrel <NUM> with the coupler <NUM> of the delivery cannula <NUM> prevents premature proximal movement of the delivery cannula <NUM> while the introducer device <NUM> is being placed within the vertebral body through the access cannula <NUM>.

The introducer device <NUM> includes a shaft <NUM> coupled to the actuator <NUM>, and more particularly to the frame <NUM> of the handle <NUM>. The shaft <NUM> includes a rigid proximal portion <NUM> and a flexible distal portion <NUM>. <FIG> and <FIG> show the proximal portion <NUM> of the shaft <NUM> extending through the bore of the barrel <NUM> to a position within the interior of the handle <NUM>. The proximal portion <NUM> of the shaft <NUM> may be axially and rotationally fixed relative to the actuator <NUM>. The proximal portion <NUM> may be defined between a proximal end <NUM> of the shaft <NUM>, and an interface <NUM> between the proximal and distal portions <NUM>, <NUM> of the shaft <NUM>. The distal portion <NUM> may be defined between the interface <NUM> and a distal end <NUM> of the shaft <NUM> opposite the proximal end <NUM>. A length of the shaft <NUM> may be defined between the proximal and distal ends <NUM>, <NUM> with the length being sufficient for the shaft <NUM> to extend through and be operable beyond the distal end <NUM> of the access cannula <NUM> as shown in <FIG>. As such, the introducer device <NUM> is configured to be directed through the access cannula <NUM> to locations within the interior region of the vertebral body.

The proximal portion <NUM> may include rigid material(s) with sufficient mechanical properties to avoid more than minimal flexure. Further, the proximal portion <NUM> may define a lumen <NUM> extending between the proximal end <NUM> of the shaft <NUM> and the interface <NUM> such that the proximal portion <NUM> is tubular in shape with the tubular geometry contributing to its relatively greater stiffness than the geometry of the distal portion <NUM>. In particular and with further reference to <FIG> and <FIG>, the distal portion <NUM> may include a proximal segment <NUM>, a distal segment <NUM>, and a flexing region <NUM> between the proximal and distal segments <NUM>, <NUM>. The proximal segment <NUM> includes a boss <NUM> disposed within a complementary bore <NUM> of the proximal portion <NUM> of the shaft <NUM>. The engagement of the boss <NUM> and the bore <NUM> defines the interface <NUM> joining the proximal and distal portions <NUM>, <NUM> of the shaft <NUM>, and the joining may be facilitated through brazing, welding, adhesive, or other suitable joining process. The proximal segment <NUM> distal to the boss <NUM> may be tubular in shape with an outer diameter equal to that of the proximal portion <NUM> of the shaft <NUM> to provide a smooth transition across the interface <NUM>. The distal segment <NUM> may also be tubular in shape with an outer diameter equal to that of the proximal segment <NUM>. The distal segment <NUM> defines a channel <NUM> sized to receive a pulling element <NUM> of the introducer device <NUM> to be described.

The flexing region <NUM> includes a pre-set curve in an unconstrained state to define an inner curved surface <NUM> opposite an outer curved surface <NUM>. More particularly, a taper <NUM>, <NUM> at each of the opposing ends of the flexing region <NUM> define transitions from the flexing region <NUM> to the proximal and distal segments <NUM>, <NUM>. The tapers <NUM>, <NUM> extend radially inward to form a cavity <NUM> in communication with the lumen <NUM> of the proximal portion <NUM>. In other words, the cavity <NUM> may be considered an axial bifurcation of a curved segment of a tubular structure. The outer curved surface <NUM> may define a portion of the cavity <NUM>, and the inner curved surface <NUM> may appear as a smooth transition between the proximal and distal segments <NUM>, <NUM> such that the inner curved surface <NUM> is somewhat convex-concave in geometry. The cavity <NUM> results in the flexing region <NUM> being thin in thickness along its length (relative to width), the flexing region <NUM> is configured to flex or bend about its minor axis between, for example, the configurations shown in <FIG> and <FIG>.

The distal portion <NUM>, and more particularly at least the flexing region <NUM>, may include a superelastic shape memory material such as a nickel titanium alloy (i.e., Nitinol). The superelastic shape memory material is formed to assume the pre-set curve such that, in the unconstrained state, the superelastic shape memory material moves the distal portion <NUM> of the shaft <NUM> upwardly away from the proximal portion <NUM> of the shaft <NUM>. For example, <FIG> and <FIG> show the distal portion <NUM> oriented at an angle of approximately <NUM> degrees relative to the proximal portion <NUM>. It is contemplated that the pre-set curve may be designed within the range of approximately <NUM> to <NUM> degrees, and more particularly within the range of approximately <NUM> to <NUM> degrees, and even more particularly within the range of approximately <NUM> to <NUM> degrees. As to be described in greater detail, when the introducer device <NUM> is directed through the access cannula <NUM>, the pre-set curve facilitates positioning the distal end <NUM> of the shaft <NUM> at a location within the vertebral body that is offset from the longitudinal axis.

The introducer device <NUM> includes the pulling element <NUM> coupled to the actuator <NUM> and the shaft <NUM>. The pulling element <NUM> is configured to be selectively tensioned to alter the extent of the pre-set curve. With continued reference to <FIG>, the pulling element <NUM> includes a proximal end <NUM> coupled to the actuator <NUM>, and more particularly the control surface <NUM> of the actuator <NUM>. The pulling element <NUM> may extend through an aperture (not identified) in the control surface <NUM> and secured proximal to the control surface <NUM> with an interference connector <NUM>, for example a ferrule, nut, swaged sleeve, clamp, or other suitable connector. The connector <NUM> may be sized to movably ride within a slot defined by complementary pockets <NUM> in each of the housing shells <NUM>, <NUM> (one identified in <FIG> and <FIG>). An input to the control surface <NUM> (e.g., pulled towards the handle <NUM>) urges the connector <NUM> proximally within the slot, thereby tensioning the pulling element <NUM>.

The pulling element <NUM> includes a distal end <NUM> opposite the proximal end <NUM> coupled at or near the distal end <NUM> of the shaft <NUM>. As best shown in <FIG> and <FIG>, the pulling element <NUM> extends through the lumen <NUM> of the proximal portion <NUM> of the shaft <NUM>, along the outer curved surface <NUM> of the flexing region <NUM>, and through the channel <NUM> of the distal segment <NUM>. The distal end <NUM> may be coterminous with the distal end <NUM> of the shaft <NUM>. The distal end <NUM> of the pulling element <NUM> may be joined at or near the distal end <NUM> of the shaft <NUM> through brazing, welding, adhesive, interference fit, or other suitable joining process. The pulling element <NUM> may be monolithic in construction and formed from a metal, polymer, composite, or combination thereof. For example, the pulling element <NUM> may be a wire rope, a wire, a rod, and the like, of solid or hollow construction.

The flexing region <NUM> includes the pre-set curve in the unconstrained state, which may include minimal or zero tension being exerted on the pulling element <NUM>. It should be appreciated that some tension may be on the pulling element <NUM> in the unconstrained state. In the unconstrained state, the distal portion <NUM> of the shaft <NUM> is oriented, curved, bent, or angled relative to the proximal portion <NUM> of the shaft <NUM>, as shown in <FIG>, <FIG> and <FIG>. As mentioned, the input to the control surface <NUM> increases the tension on the pulling element <NUM> to move the pre-set curve to a constrained state in which the distal portion <NUM>, and more particularly the flexing region <NUM>, at least partially straightens. The constrained state may include more tension being exerted on the pulling element <NUM> than the unconstrained state. <FIG> shows the pre-set curve in one example of the constrained state. In a manner to be described, moving the pre-set curve to the constrained state may be indicated for directing the introducer device <NUM> through and/or removing the introducer device <NUM> from the access cannula <NUM>.

With the pre-set curve in the constrained state, the superelastic shape memory material of the distal portion <NUM> stores potential energy. Upon releasing of the input to the control surface <NUM>, the potential energy stored by the superelastic shape memory material is sufficient to overcome the tension on the pulling element <NUM> no longer constrained by the input. In other words, releasing the input to the control surface <NUM> relaxes (i.e., reduces the tension on) the pulling element <NUM>, and the pre-set curve moves from the constrained state to the unconstrained state in which the distal portion <NUM> of the shaft <NUM> orients, curves, bends, or angles relative to the proximal portion <NUM> of the shaft <NUM> to a greater extent than the constrained state. With the distal portion <NUM> within the vertebral body, the pre-set curve moving from the constrained state to the unconstrained state may displace cancellous bone within the vertebral body, and/or position the distal end <NUM> of the shaft <NUM> at a target site that is offset from the longitudinal axis, as shown in <FIG>. A direction of the orientation, curve, bend, or angle may correlate to indicia <NUM> disposed on a proximal side of the actuator <NUM>, and more particularly the frame <NUM>, thereby visible to the practitioner.

The actuator <NUM> may include a locking mechanism <NUM> operably coupling the housing <NUM> and the control surface <NUM> and configured to permit selective locking of the control surface <NUM> in one of a plurality of positions. <FIG> and <FIG> show one possible implementation of the locking mechanism <NUM> as a ratchet including a rack <NUM> coupled to the control surface <NUM> configured to engage a pawl <NUM> coupled to the housing <NUM>. The rack <NUM> is shown as a protrusion extending proximally from the control surface <NUM> with a plurality of teeth disposed along an arcuate surface. The pawl <NUM> may be a cross-member extending between the housing shells <NUM>, <NUM> and including an edge configured to releasably engage one of the plurality of teeth of the rack <NUM>. Each of the teeth may correspond to one of the plurality of positions in which the control surface <NUM> may be locked relative to the housing <NUM>. Actuating the locking mechanism <NUM> to lock the control surface <NUM> maintains the tension on the pulling element <NUM>, and consequently an extent of the constrained state of the pre-set curve in the plurality of positions. Other possible constructions of the locking mechanism are contemplated.

The introducer device <NUM> includes the delivery cannula <NUM>, and the delivery cannula <NUM> includes a delivery hub <NUM>, the coupler <NUM> on the delivery hub <NUM>, and a flexible sheath <NUM> extending from the delivery hub <NUM>. The sheath <NUM> overlies the shaft <NUM> of the introducer device <NUM> and, in manners to be further described, performs several functions of the vertebral augmentation, for example, providing a pathway for positioning of a balloon <NUM> and/or for the delivery of the curable material. The sheath <NUM> includes a proximal end <NUM> (see <FIG>) coupled to the delivery hub <NUM>, and a distal end <NUM> opposite the proximal end <NUM> and configured to be positioned at or near the distal end <NUM> of the shaft <NUM>. As best shown in <FIG> and <FIG>, the distal end <NUM> of the sheath <NUM> is slightly proximal to the distal end <NUM> of the shaft <NUM>. The sheath <NUM> may be tubular in shape and define a lumen <NUM> sized to slidably and snugly receive the shaft <NUM> and the pulling element <NUM>. Owing to the presence of the cavity <NUM> of the flexing region <NUM>, a slight gap may exist within the lumen <NUM> between the sheath <NUM> and the outer curved surface <NUM> of the distal portion <NUM> of the shaft <NUM>. A length of the sheath <NUM> defined between the proximal and distal ends <NUM>, <NUM> may be sufficient for the sheath <NUM> to extend through and be operable beyond the distal end <NUM> of the access cannula <NUM>, as shown in <FIG>.

The sheath <NUM> is flexible and configured to conform to the shaft <NUM>, and more particularly to the distal portion <NUM> of the shaft <NUM>. The sheath <NUM> may be formed from a flexible biocompatible polymer having sufficient hoop strength such that the lumen <NUM> remains patent upon removal of the introducer device <NUM> from the sheath <NUM>. Suitable flexible polymers include polypropylene, polyether ether ketone (PEEK), and the like. The sheath <NUM> may be formed from a flexible biocompatible metal, composite, and combinations thereof, with or without reinforcing features such as filament windings or braids. At least a distal portion <NUM> of the sheath <NUM> is configured to conform to the distal portion <NUM> of the shaft <NUM> as the pre-set curve is in the constrained state for insertion of the distal portion <NUM> and the distal portion <NUM> of the sheath <NUM> through the lumen of the access cannula <NUM> to within the vertebral body, and further configured to conform to the distal portion <NUM> of the shaft <NUM> as the pre-set curve is moved from the constrained state to the unconstrained state. <FIG> shows the pre-set curve in the unconstrained state with the distal portion <NUM> of the sheath <NUM> conforming to the distal portion <NUM> of the shaft <NUM>.

The introducer device <NUM> is removable from the sheath <NUM> with the distal end <NUM> of the sheath <NUM> remaining positioned at the target site offset from the longitudinal axis. As a result, the aforementioned pathway(s) are achievable to contralateral locations within the vertebral body. The pathway(s) facilitate the remaining steps of the vertebral augmentation procedure to be described.

Additionally or alternatively, the vertebra augmentation procedure may include directing an electrode assembly through the sheath <NUM> with the distal portion <NUM> of the sheath <NUM> remaining curved. One exemplary electrode assembly that is sufficiently flexible for navigating the curved distal portion <NUM> is described in <CIT>. The electrode assembly may be bipolar or monopolar. It is contemplated that the electrode assembly may be irrigated such that a fluid is infused into the adjacent tissue prior to and/or during ablation. It is further contemplated that the electrode assembly may be cooled, for example, by circulating a fluid within pathways internal to the electrode assembly. With the electrode assembly being deployed contralaterally, procedures such as intraosseous tumor ablation, basivertebral denervation, and the like, are achievable through a unipedicular approach.

Additionally or alternatively, the vertebra augmentation procedure may include deploying an implant through the sheath <NUM> with the distal portion <NUM> of the sheath <NUM> remaining curved. One exemplary implant is described in commonly-owned <CIT>, and commonly-owned <CIT>. It is further contemplated that the implant may include an intervertebral spacer (i.e., a cage), a mesh bag, or the like, to be deployed within the intervertebral disc space or another appropriate anatomical location, respectively.

A workflow of performing a vertebral augmentation with the system <NUM> will now be described with particular reference to <FIG>, <FIG>, <FIG> and <FIG>. The vertebra with the offending vertebral body may be confirmed on fluoroscopic imaging. An incision may be made in the overlying paraspinal musculature lateral of midline generally in alignment with one of the pedicles of the vertebra. The distal end <NUM> of the access cannula <NUM>, with the trocar disposed therein, is directed through the pedicle a position beyond the cortical rim and within the interior region of the vertebral body, and the trocar is removed. The access cannula <NUM> provides the working channel to within the interior region of the vertebral body along the longitudinal axis. The cannula hub <NUM> is exposed and configured to be engaged by the introducer device <NUM>.

As previously mentioned, the shaft <NUM> of the introducer device <NUM> has a length sufficient to extend through and be operable beyond the distal end <NUM> of the access cannula <NUM>. Further, the length of the shaft <NUM> is fixed relative to the actuator <NUM>. Thus, when the introducer device <NUM> is positioned in operable engagement with the cannula hub <NUM> of the access cannula <NUM>, the shaft <NUM> having a fixed length extends beyond the distal end <NUM> of the cannula shaft <NUM>, also having a fixed length, by a fixed distance. In other words, with the access cannula <NUM> secured to the vertebra, the cannula hub <NUM> may be at a fixed distance from the distal end <NUM> and serve as a datum for subsequently introduced instrumentation. In certain instances, it may be desirable for the practitioner to have the shaft <NUM> of the introducer device <NUM> extend beyond the distal end <NUM> of the access cannula <NUM> by a distance less than the fixed distance. To do so, the practitioner may manually retract the introducer device <NUM> proximally relative to the access cannula <NUM>. The arrangement may require the practitioner to manually support and control the introducer device <NUM>, perhaps for prolonged periods, which may be undesirable or unfeasible with deploying additional instrumentation.

In some configurations, the system <NUM> of the present disclosure advantageously provides for the access cannula <NUM> being selectively adjustable such that the datum provided by the access cannula <NUM> may be selectively tuned. As a result, the practitioner may position the introducer device <NUM> in operable engagement with the cannula hub <NUM>, as this is generally preferable, yet selectively control the distance of extension of the shaft <NUM> of the introducer device <NUM> from the distal end <NUM> of the access cannula <NUM>. It is to be understood that the access cannula <NUM> that is adjustable is an optional feature of the system <NUM>, and more conventional access cannulas may also be utilized.

Referring to <FIG> and <FIG>, the cannula hub <NUM> includes a shaft hub <NUM>, a tuning hub <NUM>, and complementary coupling features <NUM> movably coupling the tuning hub <NUM> to the shaft hub <NUM>. The shaft hub <NUM> is rigidly coupled to the cannula shaft <NUM>, and more particularly to the proximal end <NUM> of the cannula shaft <NUM>. Each of the shaft hub <NUM> and the tuning hub <NUM> define bores (not identified) coaxially aligned with one another and with the lumen of the access cannula <NUM> for receiving an elongate member of instrumentation of the system <NUM>, for example, the shaft <NUM> of the introducer device <NUM>, the sheath <NUM> of the delivery cannula <NUM>, and/or a balloon tube <NUM> of the expandable member assembly <NUM>. The shaft hub <NUM> includes a proximally-directed surface <NUM>, and owing to the cannula shaft <NUM> having a fixed length and being rigidly fixed to the cannula shaft <NUM>, the proximally-directed surface <NUM> is at a fixed distance from the vertebral body when the distal end <NUM> of the cannula shaft <NUM> is positioned within the vertebral body. Thus, it may be considered that the proximally-directed surface <NUM> provides the datum previously mentioned. The tuning hub <NUM> is movably coupled to the shaft hub <NUM> with the coupling features <NUM>. <FIG> and <FIG> show the coupling features <NUM> including complementary threading. The tuning hub <NUM> may include a distally-directed surface <NUM>, and an interference surface <NUM> opposite the distally-directed surface <NUM>. The interference surface <NUM>, in a broadest sense, is configured to be engaged by the instrumentation of the system <NUM>, for example, the introducer device <NUM>, the spacer hub <NUM>, the delivery cannula <NUM>, and/or the expandable member assembly <NUM>. For example, <FIG> and <FIG> show the distal portion <NUM> of the spacer hub <NUM> engaging the interference surface <NUM>. The interference surface <NUM> prevents distal movement of the instrument <NUM>, <NUM>, <NUM>, <NUM> relative to the access cannula <NUM> while permitting proximal movement of the instrument <NUM>, <NUM>, <NUM>, <NUM> relative to the access cannula <NUM>. In other words, a distance from the interference surface <NUM> to the proximally-directed surface <NUM> providing the datum contributes to the distance by which the shaft <NUM> of the introducer device <NUM> extends from the distal end <NUM> of the access cannula <NUM>.

With continued reference to <FIG> and <FIG>, the tuning hub <NUM> is configured to be supported in a plurality of supported positions to facilitate selective adjustment of an axial position of the interference surface <NUM> of the tuning hub <NUM> relative to the datum. For example, the tuning hub <NUM> may be in an initial position (not shown) in which the distally-directed surface <NUM> of the tuning hub <NUM> abuts the proximally-directed surface <NUM> of the shaft hub <NUM>. The interference surface <NUM> of the tuning hub <NUM> is at a minimum distance from the datum in the initial position. With the tuning hub <NUM> supported in the initial position, the shaft <NUM> of the introducer device <NUM> extends from the distal end <NUM> of the access cannula <NUM> by an initial length, which may be resolved in an x-component along the longitudinal axis and a y-component perpendicular to the longitudinal axis. With abutment of surfaces <NUM>, <NUM> preventing further distal movement of the tuning hub <NUM> relative to the shaft hub <NUM>, the initial distance may be a greatest length by which the shaft <NUM> of the introducer device <NUM> extends from the distal end <NUM> of the access cannula <NUM>.

Prior to or after deploying the introducer device <NUM>, the practitioner may selectively tune the access cannula <NUM> to selectively adjust the axial position of the interference surface <NUM> relative to the datum. The practitioner may proximally move the tuning hub <NUM> relative to the shaft hub <NUM> to a first position in which the interference surface <NUM> is at a first distance (d<NUM>) from the datum provided by the shaft hub <NUM>, as shown in <FIG>. The selective adjustment of the interference surface <NUM> may be facilitated by the coupling features <NUM>, for example the complementary threads, which move the tuning hub <NUM> relative to the shaft hub <NUM> upon receiving a twisting input from the practitioner.

With the instrument the introducer device <NUM> positioned in operable engagement with the cannula hub <NUM> (i.e., engaging the spacer hub <NUM> that is engaging the tuning hub <NUM>) while the tuning hub <NUM> supported in the first position, the shaft <NUM> of the introducer device <NUM> extends from the distal end <NUM> of the access cannula <NUM> by a first length, which may be resolved in the x-component (x<NUM>) and the y-component (y<NUM>). The practitioner may proximally move the tuning hub <NUM> relative to the shaft hub <NUM> to a first supported position in which the interference surface <NUM> is at a second distance (d<NUM>) from the datum provided by the shaft hub <NUM>, as shown in <FIG>. With the instrument the introducer device <NUM> positioned in operable engagement with the cannula hub <NUM> while the tuning hub <NUM> supported in the second supported position, the shaft <NUM> of the introducer device <NUM> extends from the distal end <NUM> of the access cannula <NUM> by a second length, which may be resolved in the x-component (x<NUM>) and the y-component (y<NUM>). It is appreciated that that second length is less than the first length in each of the x- and y-components, as the second distance is greater than the first distance, which increases an overall length of the access cannula <NUM> defined between the interference surface <NUM> and the distal end <NUM>.

As mentioned, the instrument <NUM>, <NUM>, <NUM> may be the delivery cannula <NUM> including the delivery hub <NUM> and the sheath <NUM> extending from the delivery hub <NUM>. <FIG> and <FIG> show the delivery hub <NUM> abutting the distal portion <NUM> of the spacer hub <NUM>, which is engaging the interference surface <NUM> of the tuning hub <NUM>. The interference surface <NUM> may be selectively adjusted to move the distal end <NUM> of the sheath <NUM> relative to the distal end <NUM> of the access cannula <NUM>. <FIG> shows the distal end <NUM> of the sheath <NUM> at the first length, resolved in the x- and y-components (x<NUM>, y<NUM>), with the interference surface <NUM> at the first distance (d<NUM>) from the datum, and <FIG> shows the distal end <NUM> of the sheath <NUM> at the second length, resolved in the x- and y-components (x<NUM>, y<NUM>), with the interference surface <NUM> at the second distance (d<NUM>) from the datum. Thus, with the tuning hub <NUM> in a desired one of the supported positions, the practitioner may enjoy the benefit of engaging the instrument <NUM>, <NUM>, <NUM> with the access cannula <NUM> (e.g., abutting, removably coupling, etc.), and achieving a desired length of extension of the instrument <NUM>, <NUM>, <NUM> from the distal end <NUM> of the access cannula <NUM> without needing to manually retract or support the instrument <NUM>, <NUM>, <NUM>.

Referring now to <FIG>, the introducer device <NUM>, including the sheath <NUM>, is directed through the access cannula <NUM> in the manner previously described. In particular, the introducer device <NUM> may be provided with the pre-set curve in the unconstrained state, and the distal portion <NUM> of the sheath <NUM> conforming to the pre-set curve. The superelastic shape memory material biases the distal portion <NUM> of the shaft <NUM>, along with the distal portion <NUM> of the sheath <NUM>, away from an axis of the proximal portion <NUM> of the shaft <NUM>. The practitioner provides an input to the actuator <NUM>, for example moving the control surface <NUM> towards the handle <NUM>, to increase the tension the pulling element <NUM>. The tensioning of the pulling element <NUM> moves the pre-set curved from the unconstrained state to the constrained state against the biasing force from the superelastic shape memory material. In the constrained state, the pre-set curve at least partially straightens along with the distal portion <NUM> of the sheath <NUM>. More particularly, the pre-set curve straightens to an extent that the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> may be directed through the lumen of the access cannula <NUM>. It is understood that the distal portion <NUM> of the shaft <NUM> need not be entirely straight, as the access cannula <NUM> constrains the distal portion <NUM> as it is advanced therethrough. Yet the distal portion <NUM> of the shaft <NUM> should be straightened to an extent to permit ease with insertion of the shaft <NUM> and the sheath <NUM> along the lumen of the access cannula <NUM> as it is advanced therethrough. The pre-set curve may be selectively locked with the locking mechanism <NUM>.

The shaft <NUM> of the introducer device <NUM> and the sheath <NUM> of the delivery cannula <NUM> are directed through the access cannula <NUM> in the constrained state. Another input is provided to the actuator <NUM>, which may be considered removal of the earlier input. The removal of the input may be performed quickly or in a controlled manner. The pulling element <NUM> is relaxed, and/or the tension on the pulling element <NUM> is reduced. The superelastic shape memory material releases the stored potential energy to move the pre-set curve from the constrained state to the unconstrained state. The removal of the input may be performed when the distal end <NUM> of the shaft <NUM> is at least substantially in registration with the distal end <NUM> of the access cannula <NUM>. At least momentarily, the pre-set curve may not be constrained from the pulling element <NUM> but otherwise constrained from the cannula shaft <NUM> of the access cannula <NUM>. The introducer device <NUM> and the sheath <NUM> are advanced distally relative to the access cannula <NUM> to position the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> within the interior of the vertebral body. As the introducer device <NUM> and the sheath <NUM> are being advanced, the pre-set curve, in the unconstrained state, displaces cancellous bone within the vertebral body, and/or positions the distal end <NUM> of the shaft <NUM> (as well as the distal end <NUM> of the sheath <NUM>) at the target site that is offset from the longitudinal axis, as shown in <FIG>. Additionally or alternatively, removal of the input may be performed while the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> are being advanced beyond the distal end <NUM> of the access cannula <NUM>. The removal of the input while advancing may facilitate achieving a desired curvature (e.g., steeper or shallower) different than the curvature of the pre-set curve. The desired curvature may be facilitated by selectively locking the introducer device <NUM> with the locking mechanism <NUM> prior to advancement. Additionally or alternatively, removal of the input may be performed when the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> are positioned beyond the distal end <NUM> of the access cannula <NUM>. The removal of the input after advancing may result in a sweeping motion within the vertebral body and displace cancellous bone accordingly, as generally shown in <FIG>. The shaft <NUM> of the introducer device <NUM> may be removed from the sheath <NUM> with the sheath <NUM> remaining positioned at the target site offset from the longitudinal axis.

The system <NUM> advantageously facilitates repositioning of the sheath <NUM>, and in particular without requiring the sheath <NUM> be removed from the access cannula <NUM> to be redeployed. Existing systems requiring removal of the sheath <NUM> may undesirably increase the likelihood of material degradation of the sheath <NUM>. For example, in cases where a sheath is formed from a polymer such as PEEK, there may be pronounced frictional forces on the sheath <NUM> from the distal end <NUM> of the access cannula <NUM> as it is being removed. With the system <NUM> including the introducer device <NUM>, the practitioner may provide another input to the actuator <NUM> to increase the tension the pulling element <NUM> while the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> are within the interior region of the vertebral body. The practitioner may manipulate the handle <NUM> as desired, then actuate the actuator to reduce the tension on the pulling element <NUM> to move the pre-set curve from the constrained state to the unconstrained state to position the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM> at a second target site that is offset from the longitudinal axis. It is understood that any number of subsequent inputs may be provided to the control surface <NUM> to selectively adjust the curvature of the distal portion <NUM> of the shaft <NUM> and the distal portion <NUM> of the sheath <NUM>, and multiple inputs may be provided for creating a cavity of a desired shape within the interior region of the vertebral body.

In certain implementations, it may be desirable to reposition the sheath <NUM> after removal of the introducer device <NUM> from the sheath <NUM>, for example, after ascertaining positioning of the sheath <NUM> within the vertebral body as described below. The introducer device <NUM> may be directed through the sheath <NUM> in a manner similar to that previously described for the access cannula <NUM>. In particular, the introducer device <NUM> may be actuated to approximate the curvature of the distal portion <NUM> of the sheath <NUM> as it is being directed therethrough. Once the introducer device <NUM> is deployed, the input(s) may be provided to and removed from the control surface <NUM> of the actuator <NUM> to reposition the sheath <NUM> at the second or subsequent target site without requiring removal of the sheath <NUM>. The shaft <NUM> of the introducer device <NUM> may again be removed from the sheath <NUM> with the sheath <NUM> remaining positioned at the second or subsequent target site offset from the longitudinal axis.

Often, it is desirable to ascertain and/or confirm positioning of the instrumentation within the vertebral body. An existing manner by which this may be accomplished is a single radiopaque marking on a shaft detectable by fluoroscopy. The ascertaining and/or confirming positioning of the introducer device <NUM>, given its selective adjustment of curvature, is associated with challenges not adequately addressed by existing devices. For example, a lateral x-ray image of the single radiopaque marking may not provide sufficient precision as to the extent of curvature in the mediolateral directions. Likewise, an anterior-posterior (A/P) image of the single radiopaque marking may not provide sufficient precision as to the position of the shaft in the anterior and posterior directions. Moreover, disposing the radiopaque marking(s) on the shaft does not adequately account for systems, such as the system <NUM> of the present disclosure, in which the shaft <NUM> is removed from within the sheath <NUM> and the sheath <NUM> remains movably positioned within the vertebral body. The shaft <NUM> may be formed from a polymer that is not meaningfully visible on x-ray imaging.

The system <NUM> of the present disclosure advantageously provides features and methods for more accurately ascertaining and/or confirming intraoperatively, through fluoroscopic imaging, the position and/or the curvature of the distal portion <NUM> of the sheath <NUM> within the interior region of the vertebral body. The delivery cannula <NUM> of the system <NUM> includes at least two radiopaque markers <NUM> on the distal portion <NUM> of the sheath <NUM> (i.e., not on the shaft <NUM> of the introducer device <NUM>) with the radiopaque markers <NUM> spaced apart from one another by a fixed spacing along the distal portion <NUM>. The at least two radiopaque markers <NUM> may be exactly two radiopaque markers <NUM>, however, three, four, or five or greater radiopaque markers may be used. The radiopaque markers <NUM> are detectable by fluoroscopy or other x-ray imaging device, and the x-ray images from the fluoroscopy are configured to be displayed on a display <NUM>, referenced generally in <FIG>. For example, the radiopaque markers <NUM> may be one of dots, bands, rings, and lines. <FIG> shows five sets of x-ray images with each set including a lateral x-ray image and a corresponding A/P x-ray image (labeled (A)-(E)). The cannula shaft <NUM> including its distal end <NUM> is shown positioned within a schematic representation of the vertebral body. The introducer device <NUM> is not shown in <FIG> (i.e., the shaft <NUM> has been removed from the sheath <NUM> or the shaft <NUM> is not meaningfully visible on fluoroscopy). It is to be understood that the radiopaque markers <NUM> are an optional feature of the system <NUM>, and more conventional methods may also be utilized.

Referring first to Set A, the display <NUM> shows the lateral x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a first lateral distance in a first configuration, for example a first curved configuration. The display <NUM> shows the A/P x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a first A/P distance in the first configuration. The first lateral distance is greater than the first A/P distance, and Set A may be representative of at least one of (a) the pre-set curve of the shaft <NUM> being in the constrained state, and (b) the distal portion <NUM> of the sheath <NUM> being just beyond the distal end <NUM> of the access cannula <NUM>. The latter includes the sheath <NUM> is exposed minimally from the access cannula <NUM>, and thus the sheath <NUM> is unable to curve more than minimally. Given the posterior approach of the access cannula <NUM>, the radiopaque markers <NUM> appear adjacent one another in the first A/P image. In the first lateral x-ray image, however, the relatively minimal curvature results in the radiopaque markers <NUM> appearing at or nearly at the fixed spacing along the distal portion <NUM>, because the pre-set curve of the shaft <NUM> is substantially straight.

Set B shows a second configuration, for example a second curved configuration, which may be representative of at least one of (a) the pre-set curve of the shaft <NUM> being in a slightly less constrained state than the first configuration shown in Set A, and (b) the distal portion <NUM> of the sheath <NUM> being positioned beyond the position of the distal portion <NUM> shown in Set A. The display <NUM> shows the lateral x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a second lateral distance in the second configuration, and the A/P x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a second A/P distance in the second configuration. The second lateral and A/P distances are different than the first lateral and A/P distances. Further, the second lateral distance is less than the first lateral distance, and the second A/P distance is greater than the first A/P distance. In other words, as the sheath <NUM> is curved into the paper of the left column of lateral x-ray images of <FIG>, the distance between the two radiopaque markers <NUM> will appear to decrease. Likewise, the corresponding curving of the sheath <NUM> of the right column of A/P x-ray images is to the right, and the distance between the two radiopaque markers <NUM> will appear to increase.

Set C shows a third configuration, for example a third curved configuration, which may be representative of at least one of (a) the pre-set curve of the shaft <NUM> being in a slightly less constrained state than the second configuration shown in Set B, and (b) the distal portion <NUM> of the sheath <NUM> being positioned beyond the position of the distal portion <NUM> shown in Set B. The display <NUM> shows the lateral x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a third lateral distance in the third configuration, and the A/P x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a third A/P distance in the third configuration. The third lateral distance is less than the second lateral distance, and the third A/P distance is greater than the second A/P distance. Set D shows a fourth configuration, for example a fourth curved configuration, which may be representative of at least one of (a) the pre-set curve of the shaft <NUM> being in a slightly less constrained state than the third configuration shown in Set C, and (b) the distal portion <NUM> of the sheath <NUM> being positioned beyond the position of the distal portion <NUM> shown in Set C. The display <NUM> shows the lateral x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a fourth lateral distance in the fourth configuration, and the A/P x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a fourth A/P distance in the fourth configuration. The fourth lateral distance is less than the third lateral distance, and the fourth A/P distance is greater than the third A/P distance. Finally, Set E shows a fifth configuration, for example a fifth curved configuration, which may be representative of at least one of (a) the pre-set curve of the shaft <NUM> being in the unconstrained state, and (b) the distal portion <NUM> of the sheath <NUM> being fully extended from the access cannula <NUM>. The display <NUM> shows the lateral x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a fifth lateral distance in the fifth configuration, and the A/P x-ray image in which the radiopaque markers <NUM> are spaced apart from one another at a fifth A/P distance in the fifth configuration. The fifth lateral distance is less than the fourth lateral distance, and the fifth A/P distance is greater than the fourth A/P distance.

With the at least two radiopaque markers <NUM> on the sheath <NUM>, relative positions between the radiopaque markers <NUM> may be viewable on the x-ray imaging to determine a curvature of the distal portion <NUM> of the sheath <NUM>. Further, utilizing the lateral and A/P x-ray imaging in tandem in the aforementioned manner facilitates visually ascertaining and/or confirming intraoperatively the position and/or the curvature of the distal portion <NUM> of the sheath <NUM> within the interior region of the vertebral body, particularly in three-dimensions. The lateral x-ray images provide the practitioner with precise positional information in the cranial (CR) and anterior (A) directions, and additional deducible information in the lateral (L) direction (i.e., based on practicioner experience assessing the relative positions between the radiopaque markers <NUM>). The A/P x-ray images provide the practitioner with precise positional information in the cranial (CR) and lateral (L) directions, and additional deducible information in the anterior (A) direction. Collectively, the practitioner is able to view the x-ray image set on the display <NUM> and readily ascertain the position and/or curvature of the distal portion <NUM> of the sheath <NUM> within the interior region of the vertebral body. Still further, with the shaft <NUM> of the introducer device <NUM> removed from the sheath <NUM>, the sheath <NUM> may be moved as desired with the ability to quickly confirm an updated position and/or curvature of the distal portion <NUM> of the sheath <NUM>. It is contemplated that the at least two radiopaque markers <NUM> on the sheath <NUM> may utilized with the system disclosed in the aforementioned <CIT>.

With the introducer device <NUM> removed from the delivery cannula <NUM> with the distal end <NUM> of the sheath <NUM> remaining positioned at the target site offset from the longitudinal axis, the expandable member assembly <NUM> may be deployed. Referring to <FIG>, the expandable member assembly includes a balloon hub <NUM>, the balloon tube <NUM>, and a balloon <NUM>. The balloon tube <NUM> extends from the balloon hub <NUM>, and the balloon <NUM> is disposed at a distal end of the balloon tube <NUM>. The balloon hub <NUM> includes a fitting <NUM> adapted to be coupled with a fluid line in communication with a source of incompressible fluid (not shown), for example, air. The balloon <NUM> is configured to receive fluid from the source of fluid through the balloon hub <NUM> and the balloon tube <NUM> to be moved between a deflated state and an inflated state having a volume greater than the deflated state. In the deflated state, the balloon <NUM> and the balloon tube <NUM> are sized to be slidably inserted or directed through the lumen <NUM> of the sheath <NUM>. The balloon tube <NUM> may include a length sufficient for the balloon <NUM> to extend beyond the distal end <NUM> of the sheath <NUM> and within the interior region of the vertebral body. The balloon <NUM> is moved to the inflated state to compress or otherwise displace cancellous bone within the vertebral body at the target site. Returning the balloon <NUM> to the deflated state may result in a cavity being formed within the cancellous bone for delivery of the curable material (see <FIG>).

The balloon tube <NUM> and/or the balloon <NUM> are sufficiently flexible to follow the pathway defined by the lumen <NUM> of the sheath <NUM>, including the distal portion <NUM> in the curved configuration. In other words, directing the balloon <NUM> through the sheath <NUM> should not alter the curvature of the distal portion <NUM> of the sheath <NUM>. Owing to the flexibility of the balloon tube <NUM> and/or the balloon <NUM>, the expandable member assembly <NUM> may lack sufficient columnar strength to be advanced beyond the distal end <NUM> of the sheath <NUM> to penetrate the cancellous bone of the interior region. Additionally or alternatively, urging the expandable member assembly <NUM> to penetrate the cancellous bone may result in the trabeculae of the cancellous bone causing the balloon <NUM> to deviate from the desired path previously created by the introducer device <NUM> and/or the target site previously accessed by the introducer device <NUM>. The system <NUM> of the present disclosure advantageously provides for moving the sheath <NUM> relative to the expandable member assembly <NUM> to unsheathe and sheathe the balloon <NUM>. Moreover, the unsheathing and sheathing the balloon <NUM> may be performed with a syringe-style input to be further explained that is both intuitive to the practitioner and provides the practitioner with improved feel.

The spacer hub <NUM> previously introduced, in cooperation with the balloon hub <NUM>, facilitates the syringe-style input. Referring to <FIG>, <FIG> and <FIG>, the spacer hub <NUM>, in a broadest sense, is configured to facilitate proximal and distal movement of the delivery cannula <NUM> relative to the access cannula <NUM> while maintaining a position of the expandable member assembly <NUM> relative to the access cannula <NUM>. The result includes proximal and distal movement of the delivery cannula <NUM> including the sheath <NUM> relative to the expandable member assembly <NUM> including the balloon <NUM>, hence unsheathing and sheathing the balloon <NUM>, respectively. It is to be understood that the spacer hub <NUM> is an optional feature of the system <NUM>, and more conventional methods may also be utilized.

The spacer hub <NUM> includes a distal portion <NUM> configured to engage the cannula hub <NUM>, and more particularly the tuning hub <NUM>, as shown in <FIG>. The distal portion <NUM> may include a boss <NUM> sized to be seated within a complementary cavity in the cannula hub <NUM> (see <FIG>). Each of the distal portion <NUM> and the cannula hub <NUM> may include complementary coupling features (not shown), for example a releasable detent, configured to removably couple the spacer hub <NUM> to the access cannula <NUM>. The spacer hub <NUM> further includes the proximal portion <NUM> configured to be engaged by the balloon hub <NUM>, as best shown in <FIG>. The proximal and distal portions <NUM>, <NUM> are spaced apart from one another to define a void space <NUM> within which the delivery hub <NUM> of the delivery cannula <NUM> is configured to be movably disposed. The spacer hub of <FIG> shows the proximal and distal portions <NUM>, <NUM> as ring-like structures, and the spacer hub <NUM> of <FIG> show the proximal and distal portions <NUM>, <NUM> as flange-like structures.

Each of the proximal and distal portions <NUM>, <NUM> include a stop surface <NUM>, <NUM> defining the void space <NUM> with the stop surfaces <NUM>, <NUM> providing a terminus of movement of the delivery hub <NUM> in a manner to be explained. The delivery hub <NUM> abuts or engages the stop surface <NUM> of the distal portion <NUM> in a first position, and the balloon hub <NUM> engages a surface <NUM> of the proximal portion <NUM> opposite the stop surface <NUM>. The resulting arrangement is shown in <FIG> and <FIG>. The proximal and distal portions <NUM>, <NUM> may each define an aperture <NUM>, <NUM> coaxially aligned with one another and with a bore extending through the cannula hub <NUM> that is further aligned and in communication with the lumen of the cannula shaft <NUM>. The aperture or opening <NUM> on the distal portion <NUM> is at least sized to receive the balloon tube <NUM>, and the aperture <NUM> or opening of the proximal portion <NUM> is at least sized to receive a nose <NUM> of the balloon hub <NUM> (see <FIG>) to facilitate engagement of the balloon hub <NUM> with the spacer hub <NUM>. The aperture <NUM> may also be at least sized to receive the barrel <NUM> of the actuator <NUM> with the barrel <NUM> extending through the proximal portion <NUM>, as previously mentioned. As it is now understood that the delivery hub <NUM> may move proximally within the void space <NUM>, the barrel <NUM> of the actuator <NUM> extends through the aperture <NUM> to within the void space <NUM> and into abutment with the delivery hub <NUM> to prevent premature proximal movement of the delivery cannula <NUM> while the introducer device <NUM> is being placed within the vertebral body through the access cannula <NUM> (see <FIG>). In other words, friction between the cancellous bone and the distally-advancing sheath <NUM> may result in proximal forces on the delivery cannula <NUM>, and the barrel <NUM> of the actuator <NUM> abutting the delivery hub <NUM> maintains the delivery cannula <NUM> in a static position until the introducer device <NUM> is removed from the delivery cannula <NUM>.

With the balloon hub <NUM> engaging the spacer hub <NUM> and the delivery hub <NUM> in the first position, the balloon tube <NUM> may extend through, in sequence, the aperture <NUM> of the proximal portion <NUM>, the void space <NUM>, the aperture <NUM> of the distal portion <NUM>, a bore of the delivery hub <NUM>, and the sheath <NUM> extending through the bore of the cannula hub <NUM> and the lumen of the cannula shaft <NUM>. With the delivery hub <NUM> in the first position, a distal end <NUM> of the balloon <NUM> is near or in registration with the distal end <NUM> of the sheath <NUM>, as shown in <FIG>. The balloon <NUM> is in the deflated state and sheathed within the distal portion <NUM> of the sheath <NUM> in the curved configuration.

The balloon <NUM> may be unsheathed by moving the delivery cannula <NUM> proximally, and more particularly providing an input to move the delivery hub <NUM> proximally within the void space <NUM> of the spacer hub <NUM>. The delivery hub <NUM> includes wings <NUM> extending laterally and defining first control surfaces <NUM> for receiving the input from the practitioner. <FIG> best shows the wings <NUM> being arcuate in shape and mirrored relative to one another with each of the wings <NUM> configured to ergonomically be engaged by one or more fingers of the practitioner. In one example, one of the wings <NUM> is engaged by the index finger of the practitioner, and the other one of the wings <NUM> is engaged by the middle finger of the practitioner. In at least some respects the ergonomics are similar to the flanges of a barrel of a medical syringe. The practitioner provides the input to the first control surfaces <NUM>, and the delivery hub <NUM> moves proximally within the void space <NUM>, for example into engagement with the stop surface <NUM> of the proximal portion <NUM> of the spacer hub <NUM>, as shown in <FIG>. The delivery hub <NUM> may be moved a desired distance, and/or a set distance until contacting the stop surface <NUM>. The set distance may correspond to at least the distance required to unsheathe the balloon <NUM> based on its length. With continued reference to <FIG>, the proximal movement of the delivery hub <NUM> results in proximal movement of the sheath <NUM> coupled to the delivery hub <NUM> with such movement being relative to the expandable member assembly <NUM> remaining in a static position. The balloon <NUM> is unsheathed and exposed within the interior region of the vertebral body in the deflated state, after which the balloon <NUM> may be moved to the inflated state to displace the cancellous bone.

The expandable member assembly <NUM> may remain in the static position through a complementary input to the balloon hub <NUM> as the input is provided to the first control surfaces <NUM>. <FIG> show the balloon hub <NUM> including a body portion <NUM>, the nose <NUM> extending distally from the body portion <NUM>, and a flange portion <NUM> extending proximally from the body portion <NUM>. The nose <NUM> may be cylindrical in shape and sized to be positioned within the aperture <NUM> of the proximal portion <NUM> of the spacer hub <NUM>. One or more rails <NUM> may extend radially from the nose <NUM> to further facilitate the engagement of the balloon hub <NUM> with the spacer hub <NUM>. The body portion <NUM> may be relatively cylindrical in shape with an outer dimension greater than the outer diameter of the nose <NUM>. A transition surface <NUM> may demarcate the transition from the nose <NUM> to the body portion <NUM>. The transition surface <NUM> may contact the stop surface <NUM> when the balloon hub <NUM> engages the spacer hub <NUM>, for example, as shown in <FIG> and <FIG>. The flange portion <NUM> may be cylindrical in shape with an outer dimension greater than the outer diameter of the body portion <NUM>. A lumen <NUM> extends through the nose <NUM> and the body portion <NUM> and is in communication with a borehole <NUM> extending radially from the body portion <NUM>. The borehole <NUM> is configured to be coupled with the fitting <NUM> (see <FIG>), which is adapted to be in placed in communication with the fluid line.

A proximal side of the flanged portion <NUM> may define a control surface <NUM> configured to receive an input from the practitioner, also referred to as a second control surface. The flanged portion <NUM> may be circular in shape and include gripping features <NUM>, for example the ridges shown in <FIG>. With the borehole <NUM> positioned distal to the flanged portion <NUM> and further extending from the body portion <NUM> oriented transverse to the lumen <NUM> extending through the nose <NUM> and the body portion <NUM>, an entirety of the control surface <NUM> is unobstructed, exposed, or otherwise available to the practitioner for the practitioner to provide the syringe-style input. In other words, the control surface <NUM> may be the proximal-most surface of the system <NUM> and sized to be engaged by a thumb of the practitioner.

The practitioner provides the input to the first control surfaces <NUM> while simultaneously providing an input to the second control surface <NUM>. More particularly, the syringe-style input may include one of the first control surfaces <NUM> is engaged by the index finger of the practitioner, the other one of the first control surfaces <NUM> being engaged by the middle finger of the practitioner, and the second control surface <NUM> being engaged by the thumb of the practitioner. The arrangement and ergonomics may be similar to the medical syringe, and thus the arrangement is intuitive to the practitioner. The syringe-style input may include the thumb maintaining the position of the expandable member assembly <NUM> while at least one finger actuates first the control surface <NUM> to draw the delivery hub <NUM> towards the balloon hub <NUM>.

With the balloon <NUM> in the inflated state, the balloon <NUM> is returned to the deflated state to form the cavity within the cancellous bone for delivery of the curable material (see <FIG>). Moving the balloon <NUM> into and through the sheath <NUM> may be associated with undesirable interference at the distal end <NUM> of the sheath <NUM>. The retraction of the balloon <NUM> into the aperture at the distal end <NUM> may result in component compromise and/or the forces on the distal end <NUM> of the sheath <NUM> may cause the sheath <NUM> deviate from its existing path or curvature. The subsequent delivery of the curable material may not be properly located with the formed cavity. As a result, the present system <NUM> advantageously provides for sheathing the balloon <NUM> prior to withdrawal. The wings <NUM> define second control surfaces <NUM> generally opposite the first control surfaces <NUM>. The second control surfaces <NUM> are configured to receive another input from the practitioner. The practitioner provides the input to the second control surfaces <NUM>, and the delivery hub <NUM> moves distally within the void space <NUM>, for example into engagement with the stop surface <NUM> of the distal portion <NUM> of the spacer hub <NUM>, as shown in <FIG> and <FIG>. The delivery hub <NUM> moves the set distance corresponding to at least the distance required to sheathe the balloon <NUM> based on its length. Any resistance may be felt by the practitioner, which can be gradually addressed through further deflation of the balloon <NUM> and urging of the delivery hub <NUM> distally. The distal movement of the delivery hub <NUM> results in distal movement of the sheath <NUM> coupled to the delivery hub <NUM> with such movement being relative to the expandable member assembly <NUM> remaining in a static position. The balloon <NUM> is sheathed within the distal portion <NUM> of the sheath <NUM>, after which it can be confidently removed from the access cannula <NUM> and the delivery cannula <NUM>, for example, through a pulling input to the balloon hub <NUM>.

As the delivery hub <NUM> moves between the first and second positions, the delivery hub <NUM> may be radially constrained by the balloon tube <NUM> extending from the balloon hub <NUM>. In other words, the delivery hub <NUM> may "ride" on the balloon tube <NUM>. Further, the spacer hub <NUM> of <FIG> and <FIG> may rotationally constrain the delivery hub <NUM>. The spacer hub <NUM> of <FIG> and <FIG> includes opposing sides <NUM> defining opposed slots <NUM> between the opposing sides <NUM>. The slots <NUM> are sized to receive the wings <NUM> of the cannula hub <NUM>, as best shown in <FIG>. Constraining the delivery hub <NUM> from rotation prevents the sheath <NUM> from correspondingly rotating within the vertebral body, which may prevent kinking of the sheath <NUM> and/or prevent the sheath <NUM> from deviating from its existing path or curvature. Further, the wings <NUM> remaining in a fixed rotational position may instill confidence to the practitioner that the curvature of the distal portion <NUM> of the sheath <NUM> is correspondingly fixed.

The spacer hub <NUM> may be configured to pivot for exposing the coupler <NUM> of the delivery hub <NUM> for coupling of a cement delivery system <NUM> to be described. Referring to <FIG>, <FIG> and <FIG>, the spacer hub <NUM> may include a pivot <NUM> pivotably coupling the distal portion <NUM> to the proximal portion <NUM>. Each of the proximal and distal portions <NUM>, <NUM> may include a surface <NUM>a, <NUM>b collectively forming the side <NUM> of the spacer hub <NUM>. The pivot <NUM> couples the surfaces <NUM>a, <NUM>b such that, when the spacer hub <NUM> is provided between a first position shown in <FIG> and a second position shown in <FIG>, the proximal portion <NUM> articulates in a direction away from the void space <NUM>. In other words, in certain configurations, the spacer hub <NUM> may be generally U-shaped when in the first position with the surfaces <NUM>a, <NUM>b generally aligned, for example coplanar. In the second position, the proximal portion <NUM> may substantially inverted and the surfaces <NUM>a, <NUM>b are parallel.

Moving the spacer hub <NUM> from the first position to the second position may provide better access to the delivery hub <NUM>, and more particularly the coupler <NUM>, for coupling of the cement delivery system <NUM>. <FIG> show the delivery hub <NUM> in phantom and positioned in the first position in engagement with the distal portion <NUM> of the spacer hub <NUM>. While a portion of the void space <NUM> above the delivery hub <NUM> may provide some lateral access to the coupler <NUM>, it may be desirable to move the spacer hub <NUM> from the first position to the second position in the manner previously described to render the coupler <NUM> of the delivery hub <NUM> the proximal-most component of the system <NUM>.

Referring now to <FIG>, the cement delivery system <NUM> may include a housing <NUM>, a first control surface <NUM> coupled to the housing, and a second control surface <NUM> coupled to the housing <NUM>. The first and second control surfaces <NUM>, <NUM> are configured to receive inputs from the practitioner. For example, a rotational input to the first control surface <NUM> with one hand of the practitioner may advance a piston (not shown) with a chamber <NUM> to urge the curable material through the system <NUM>. An input to the second control surface <NUM> with the other hand of the practitioner may be required to permit advancement of the piston, and release of the input to the second control surface <NUM> may act as a "dead man's switch" for ceasing distal movement of the piston (and permitting proximal movement of the piston). Operation of the cement delivery system <NUM> is further disclosed in commonly owned <CIT>. Another suitable cement delivery system is disclosed in commonly owned <CIT>, and sold under the tradename PCD System by Stryker Corporation (Kalamazoo, Mich. Still another suitable cement delivery system is disclosed in commonly owned <CIT>, and sold under the tradename AutoPlex by Stryker Corporation (Kalamazoo, Mich.

The cement delivery system <NUM> may include an extension tube <NUM> is adapted to be coupled to the coupler <NUM> of the delivery cannula <NUM>, as shown in <FIG>. The extension tube <NUM> includes a proximal coupler <NUM> coupled to the chamber <NUM>, and a distal coupler <NUM> coupled to the coupler <NUM>. The arrangement establishes communication between the chamber <NUM> and the sheath <NUM> of the delivery cannula <NUM>. One or both of the proximal and distal couplers <NUM>, <NUM> may be pivotable, and additional segments of tubing may be provided. Further construction of the extension tube <NUM> is disclosed in the aforementioned <CIT>. The extension tube <NUM> advantageously provides the physician with improved maneuverability about the patient and the surgical site without placing undue stress on the surgical instrument rigidly secured within the patient. Further, in procedures where fluoroscopy is utilized, the practitioner may deliver the curable material to within the interior region the vertebral body while avoiding unnecessary exposure to radiation.

With continued reference to <FIG>, the spacer hub <NUM> is moved from the first position to the second position. The distal coupler <NUM> of the extension tube <NUM> may be coupled to the coupler <NUM> of the delivery cannula <NUM>, and the cement delivery system <NUM> operated to direct the curable material (CM) from the chamber <NUM> through the delivery hub <NUM>, through the sheath <NUM> including the distal portion <NUM> in the curve configuration, and into the cavity (CA) within the interior region of the vertebral body. It is contemplated that the sheath <NUM> may be proximally retracting while the curable material is being delivered so as to move the distal end <NUM> of the sheath <NUM> and locate the entry point of the curable material as desired. For example, the spacer hub <NUM> may be returned from the second position to the first position to facilitate the practitioner utilizing the syringe-style input previously described. The delivery cannula <NUM> is removed from the access cannula <NUM>. The trocar may be reintroduced through the access cannula <NUM>, and the access cannula <NUM> and trocar removed from the vertebral body. The overlying tissue may be sutured.

Referring now to <FIG> and <FIG>, another introducer device <NUM> is shown with the introducer device <NUM> configured to be directed through the access cannula <NUM> to locations within the interior of the vertebral body that are offset from the longitudinal axis. In at least some respects of the introducer device <NUM> of <FIG> and <FIG> is similar to the introducer device <NUM> previously described with like numbers indicating like components. Disclosure common to the introducer devices <NUM>, <NUM> is omitted in the interest of brevity. <FIG> shows the introducer device <NUM> in a first or slack configuration, and <FIG> shows the introducer device <NUM> in a second or tensioned configuration. The distal portion <NUM> of the shaft <NUM> includes a plurality of links <NUM> interconnected to one another and configured to articulate relative to one another. The pulling element (not shown) may extend through the shaft <NUM> with the pulling element coupled to the actuator <NUM>. An input to the control surface <NUM> of the actuator <NUM> facilitates the links <NUM> articulating relative to one another to move the introducer device <NUM> between the first configuration and the second configuration. The introducer device <NUM> and the flexible sheath <NUM> overlying the shaft <NUM> moving to the second configuration within the interior region of the vertebral body locates the distal end <NUM> of the shaft <NUM> and the distal end <NUM> of the sheath <NUM> to a location offset from the longitudinal axis. Further operation of the introducer device <NUM> may be described in commonly owned <CIT>. The introducer device <NUM> is operable with the access cannula <NUM>, the spacer hub <NUM>, delivery cannula <NUM>, the expandable member assembly <NUM>, and/or the cement delivery system <NUM>.

According to one variant, a system for augmenting a vertebral body includes an introducer device includes an actuator configured to receive an input from a user, a shaft including a rigid proximal portion coupled to the actuator and defining a proximal end of the shaft and a flexible distal portion including a pre-set curve in an unconstrained state, and a pulling element coupled to the actuator and to the shaft at or near the distal end with the pulling element extending along at least a portion of the pre-set curve, wherein tension on the pulling element is configured to be increased in response to the input to provided to the actuator to move the pre-set curve from the unconstrained state to a constrained state in which the flexible distal portion at least partially straightens, and wherein the tension on the pulling element is configured to be reduced to the unconstrained state to position the distal end of the shaft within the vertebral body at a target site that is offset from the longitudinal axis; a flexible sheath at least partially overlying the shaft with the flexible sheath having a distal end positionable near the distal end of the shaft with a distal portion of the flexible sheath conforming to the flexible distal portion as the pre-set curve moves between the constrained state and the unconstrained state, wherein the introducer device is removable from the flexible sheath with the distal end of the flexible sheath remaining at the target site offset from the longitudinal axis.

According to one variant, a system for augmenting a vertebral body includes an access cannula comprising a cannula hub, and a cannula shaft extending from the cannula hub with the cannula shaft comprising a distal end positionable within the vertebral body and defining a lumen along a longitudinal axis; an introducer device including an actuator configured to receive an input from a user; a shaft comprising a rigid proximal portion coupled to the actuator and defining a proximal end of the shaft, and a flexible distal portion, wherein a length of the shaft between the proximal end and a distal end is sufficient for the shaft to extend through and be operable beyond the distal end of the access cannula, wherein the flexible distal portion comprises a pre-set curve in an unconstrained state; a pulling element coupled to the actuator and to the shaft at or near the distal end with the pulling element extending along at least a portion of the pre-set curve, wherein altering tension on the pulling element in response to the input to provided to the actuator is configured to move the pre-set curve between the unconstrained state and a constrained state in which the flexible distal portion at least partially straightens; and a flexible sheath at least partially overlying the shaft with the flexible sheath comprising a distal end positionable near the distal end of the shaft such that the flexible sheath is configured to extend through and be operable beyond the distal end of the access cannula with a distal portion of the flexible sheath conforming to the flexible distal portion as the pre-set curve moves between the constrained state and the unconstrained state, wherein the introducer device is removable from the flexible sheath with the distal end of the flexible sheath remaining at the target site offset from the longitudinal axis. The system may include a biasing element operably coupled to the pulling element and the actuator with the biasing element configured to be at least initially in a stressed state to bias the pulling element to the constrained state, wherein the biasing element is further configured to relax in response to the input to provided to the actuator to facilitate altering the tension on the pulling element to permit the flexible distal portion to move to the unconstrained state. The biasing element may be, for example, a compression spring. The compression spring may be in the stressed state, for example, stretched relative to its natural length. The forces from the compression spring are sufficient to overcome the forces associated with the pre-set curve biased towards the unconstrained state such that the compression spring maintains the pre-set curve in the constrained state in which the flexible distal portion at least mostly straight. Upon actuating the actuator, the compressing spring may be relaxed such that the tension on the pulling element is reduced, and the pre-set curve moves from the constrained state to the unconstrained state. As a result, the above arrangement provides an introducer device that is at least mostly straight in a default configuration and curved in an actuated configuration, which may be more intuitive and/or familiar to practitioners.

Claim 1:
A system (<NUM>) for augmenting a vertebral body, said system (<NUM>) comprising:
an access cannula (<NUM>) comprising a cannula hub (<NUM>), and a cannula shaft (<NUM>)extending from said cannula hub (<NUM>) with said cannula shaft (<NUM>) comprising a distal end (<NUM>) positionable within the vertebral body and defining a lumen along a longitudinal axis (LA);
an introducer device (<NUM>) comprising:
an actuator (<NUM>) configured to receive an input from a user;
a shaft (<NUM>) comprising a rigid proximal portion (<NUM>) coupled to said actuator (<NUM>) and defining a proximal end (<NUM>) of said shaft (<NUM>), and a flexible distal portion (<NUM>), wherein said shaft comprises a distal end (<NUM>) and a length of said shaft (<NUM>) between said proximal end (<NUM>) and said distal end (<NUM>) is sufficient for said shaft (<NUM>) to extend through and be operable beyond said distal end (<NUM>) of said access cannula (<NUM>); and
a pulling element (<NUM>) coupled to said actuator (<NUM>) and to said shaft (<NUM>) at or near said distal end (<NUM>); and
a flexible sheath (<NUM>) at least partially overlying said shaft (<NUM>) with said flexible sheath (<NUM>) comprising a distal end (<NUM>) positionable near said distal end (<NUM>) of said shaft (<NUM>) such that said flexible sheath (<NUM>) is configured to extend through and be operable beyond said distal end (<NUM>) of said access cannula (<NUM>), characterized in that
said flexible distal portion (<NUM>) of said shaft (<NUM>) comprises a pre-set curve in an unconstrained state,
said pulling element (<NUM>) extends along at least a portion of said pre-set curve, wherein said actuator (<NUM>) is configured to alter tension on said pulling element (<NUM>) in response to a user input and, in response to tension on said pulling element (<NUM>) being altered, said pulling element (<NUM>) is configured to move said pre-set curve between said unconstrained state and a constrained state in which said flexible distal portion (<NUM>) at least partially straightens, and
wherein a distal portion (<NUM>) of said flexible sheath (<NUM>) is configured to conform to said flexible distal portion (<NUM>) as said pre-set curve is moved between said constrained state and said unconstrained state, and wherein said introducer device (<NUM>) is removable from said flexible sheath (<NUM>) with said distal end (<NUM>) of said flexible sheath (<NUM>) configured to remain at the target site offset from said longitudinal axis (LA).