Patent Description:
The present disclosure relates generally to medical devices used to treat tissue, including bone. More specifically, in certain embodiments, the present disclosure relates to medical devices used to displace tissue using an expandable member, such as a balloon.

<CIT> teaches a system and method for performing a surgical procedure, and in particular, to an articulating balloon catheter.

The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:.

According to the present invention, a bone displacement device comprises.

In general, tissue treatment devices may include elongate members, expandable members, and other components. In some instances, an elongate member of a tissue treatment device may be advanced to a treatment location and an expandable member expanded to displace tissue. For example, a bone displacement device may be disposed within a vertebra of a patient and an expandable member expanded to displace portions of the vertebra. Similarly, such devices may be utilized in other areas of the body with other types of tissue. For convenience, including when describing the illustrated embodiments, this disclosure references "bone displacement" or "bone displacement devices," however, such disclosure may be analogously applied to devices, elements, and procedures configured to displace or otherwise treat tissue in other portions of the body. For example, in some embodiments, the handle comprises a rotatable grip having female threads configured to engage with male threads of a pull member. The threads may include thread stops to limit rotation of the rotatable grip. A distal portion of the plurality of pull wires is coupled to the pull member. In such embodiments, rotation of the rotatable grip in the first direction proximally displaces the pull member and thus applies a tension force to the pull wires to articulate the distal portion of the stylet. The handle may also include a side port having a valve.

Certain bone displacement devices include an expandable member (not claimed). According to the invention, the expandable member is a balloon. expandable member may be disposed at a distal portion of the bone displacement device. In some embodiments, a proximal portion of the expandable member is attached to a distal portion of the outer tube via a tie layer. A distal portion of the expandable member can be attached to a tip tie tube. The tip tie tube may be longitudinally displaceable over the distal portion of the stylet. A protective sleeve may be disposed around the balloon when the bone displacement device is in its package, and displaced proximally over the outer tube to engage with the handle when the bone displacement device is ready to use.

In certain instances, a bone displacement device may be used by a practitioner to treat a fractured bone, such as a vertebral bone. The practitioner may displace bone by inflating an expandable member at a distal end of the bone displacement device to create a cavity into which a bone stabilizing material, such as bone cement, may be injected. The rotatable grip may be rotated in a first direction to apply a tension force to pull wires to articulate a distal portion of the bone displacement device. The distal portion of the bone displacement device may be directed - via articulation of the distal portion and/or displacement of the entire bone displacement device - to a desired location within the bone. The expandable member can be expanded to displace bone tissue adjacent the expandable member to create a cavity. The bone displacement device can be removed from the bone to allow for injection of bone cement into the cavity.

Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout.

The phrases "coupled to" and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component.

The directional terms "distal" and "proximal" are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest the practitioner during use. As specifically applied to a bone displacement device, the proximal end of the device refers to the end nearest the handle and the distal end refers to the opposite end, the end nearest a working tip of the device. If at one or more points in a procedure a physician changes the orientation of a bone displacement device, as used herein, the term "proximal end" always refers to the handle end of the device (even if the distal end is temporarily closer to the physician).

"Fluid" is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.

<FIG> illustrate different views of several bone displacement devices or osteotomes and related components. In certain views each device may be coupled to, or shown with, additional components not included in every view. Further, in some views only selected components are illustrated, to provide detail into the relationship of the components. Some components may be shown in multiple views, but not discussed in connection with every view. Disclosure provided in connection with any figure is relevant and applicable to disclosure provided in connection with any other figure or embodiment.

<FIG> depict an embodiment of a bone displacement device <NUM>. In the illustrated embodiment, the bone displacement device <NUM> comprises a handle <NUM>, a catheter <NUM>, a stylet <NUM>, and an expandable member <NUM>. <FIG> shows the bone displacement device <NUM> in a ready state where the expandable member <NUM> is not expanded and a distal portion of the bone displacement device <NUM> is not articulated. <FIG> shows the bone displacement device <NUM> in a bone displacement or cavity forming state where the expandable member <NUM> is expanded and the distal portion is articulated.

<FIG> illustrates a proximal portion of the bone displacement device <NUM>. The proximal portion comprises the handle <NUM>, a proximal portion of the catheter <NUM>, and a proximal portion of the stylet <NUM>. The catheter <NUM> may comprise an elongate outer tube <NUM> and an elongate inner tube <NUM>. The outer tube <NUM> comprises a proximal portion <NUM>. The outer tube <NUM> can be formed from any suitable polymeric material. For example, the outer tube <NUM> may be formed from polyurethane, nylon, PBT, polyethylene, polypropylene, etc. A proximal end of outer tube <NUM> can be fixedly coupled to the handle <NUM>. In some embodiments, the inner tube <NUM> is coaxially disposed within the outer tube <NUM>. The inner tube <NUM> may be formed from any of the materials listed in connection with the outer tube <NUM>, though the inner tube <NUM> and outer tube <NUM> may or may not be formed of the same material. A proximal end of the inner tube <NUM> can be fixedly coupled to the handle <NUM> at a location proximal of the proximal end of the outer tube <NUM>.

In the illustrated embodiment, the stylet <NUM> is shown to comprise a tubular shaft <NUM>. The shaft <NUM> may be formed from any suitable rigid material, such as stainless steel, titanium, nitinol, etc. A proximal end of the shaft <NUM> may be fixedly coupled to the handle <NUM> at a location proximal of the proximal end of the inner tube <NUM>. A plurality of pull wires <NUM> are coaxially disposed within the shaft <NUM>. In the illustrated embodiment, the pull wires <NUM> include a plurality of pull wires comprising seven pull wires. In other embodiments, the number of pull wires <NUM> may be three, four, five, six, eight, or more pull wires. The pull wires <NUM> may extend proximally from the shaft <NUM> and be fixedly coupled to the distal end of the shaft <NUM>. The pull wires <NUM> may be formed from any suitable material with high tensile strength. For example, the pull wires <NUM> may be formed from stainless steel, titanium, nitinol, etc. A diameter of the pull wires <NUM> may range from about <NUM> inch (<NUM>,<NUM>) to about <NUM> inch (<NUM>,<NUM>).

<FIG> illustrates a transverse cross-section of a middle portion of the bone displacement device <NUM>. As illustrated, the outer tube <NUM> includes an outer lumen <NUM>. The inner tube <NUM> is shown to be coaxially disposed within the outer lumen <NUM>. An annular space <NUM> may be formed between the outer tube <NUM> and the inner tube <NUM>. The inner tube <NUM> may include an inner lumen <NUM>. The shaft <NUM> may be coaxially disposed within the inner lumen <NUM>. The shaft <NUM> is shown to include a shaft lumen <NUM>. The pull wires <NUM> are disposed within the shaft lumen <NUM>. As depicted in <FIG>, the pull wires <NUM> collectively include seven individual pull wires <NUM>. The individual pull wires <NUM> are disposed with a first individual pull wire <NUM> centrally located and the remaining six individual pull wires <NUM> equally spaced around the first individual pull wire <NUM>. The pull wires <NUM> are shown as individual strands disposed longitudinally adjacent each other (without braiding or twisting) in the illustrated embodiment. This configuration of the pull wires <NUM> may be configured to provide adequate stiffness to the bone displacement device <NUM> to the ready state where the distal portion of the bone displacement device <NUM> is not articulated and/or to facilitate transfer of force to straighten the bone displacement device <NUM> from an articulated configuration to a non articulated configuration. In another embodiment, each pull wire <NUM> may be formed in a braid of a plurality of smaller diameter wires. Other arrangements of the pull wires <NUM> are likewise within the scope of this disclosure, including embodiments where the individual wires are braided or twisted into a cable.

Referring again to <FIG>, the handle <NUM> comprises a body <NUM> and a rotatable grip <NUM> rotatably coupled to a proximal end of the body <NUM>. The body <NUM> and rotatable grip <NUM> may be formed from any suitable polymeric material, such as polycarbonate, acrylonitrile butadiene styrene, etc. The body <NUM> may comprise a side port <NUM>. In the illustrated embodiment, the side port <NUM> extends generally proximally and laterally from a longitudinal axis of the body <NUM>. The side port <NUM> may extend at an angle ranging from <NUM> degrees to <NUM> degrees or about <NUM> degrees relative to the longitudinal axis. The side port <NUM> may be in fluid communication with the annular space (<NUM> of <FIG>. ) During some therapies, a fluid delivery device (e.g., syringe) can be releasably coupled to a proximal portion of the side port <NUM>. A valve member <NUM> may be disposed within the side port <NUM>. The valve member <NUM> may be configured to selectively permit air or fluid to be directed from the fluid delivery device, through the side port <NUM>, through the annular space <NUM>, and then to the expandable member (<NUM> of <FIG>) when the fluid delivery device is coupled to the side port <NUM>. The valve member <NUM> may also be configured to retain the air or fluid within the annular space <NUM> and the expandable member <NUM> when the fluid delivery device is removed from the side port <NUM>.

In the illustrated embodiment, the proximal end of the outer tube <NUM> is coupled to the body <NUM> at a location distal to the side port <NUM>, and the inner tube <NUM> is coupled to the body <NUM> at a location proximal to the side port <NUM>. Further, a proximal end of the shaft <NUM> can be coupled to the body <NUM> at a location proximal to the inner tube <NUM>.

The rotatable grip <NUM> may be configured to be rotated around a longitudinal axis of the handle <NUM>. As depicted, the rotatable grip <NUM> may comprise laterally extending wings <NUM> configured to be gripped by a user. In other embodiments, the rotatable grip <NUM> may comprise any suitable feature to facilitate gripping and rotation of the rotatable grip <NUM>. For example, the rotatable grip <NUM> may comprise a knob including grippable features, such as ridges, bumps, recesses, textured surface, etc. The rotatable grip <NUM> may comprise a chamber <NUM> configured to receive a pull member <NUM>. As shown in the figures, and discussed below, the pull member <NUM> of the illustrated embodiment is configured as non-rotatable relative to the rotatable grip <NUM>, or configured not to rotate with the rotatable grip <NUM>. The chamber <NUM> may include a female thread <NUM> configured to engage a male thread <NUM> of the pull member <NUM>. The female thread <NUM> may comprise proximal and distal female thread stops <NUM>. In the illustrated embodiment, the female thread stops <NUM> may include a flat face oriented perpendicular to a longitudinal axis of the rotatable grip <NUM>. In another embodiment, the female thread stops <NUM> may include a tapered face. The pull member <NUM> may include a male thread <NUM> configured to engage with the female thread <NUM>. The male thread <NUM> may comprise proximal and distal male thread stops <NUM>. In the illustrated embodiment, the male thread stops <NUM> may include a flat face oriented perpendicular to a longitudinal axis of the pull member <NUM>. In another embodiment, the male thread stops <NUM> may include a tapered face. The female thread stops <NUM> can be configured to engage with the male thread stops <NUM> to prevent over-rotation of the rotatable grip <NUM> in both a first direction and a second direction. In some instances, over-rotation of the rotatable grip <NUM> may result in excess strain or breakage of the shaft <NUM> and/or one or more of the individual pull wires <NUM>. Thus, the threads may be configured with a positive stop to minimize excess force and subsequent breakage. In another embodiment, the chamber <NUM> may include a male thread <NUM> and male thread stops <NUM> while the pull member <NUM> includes a female thread <NUM> and female thread stops <NUM>.

In the illustrated embodiment, the proximal ends of the pull wires <NUM> are fixedly coupled to the pull member <NUM>. When the rotatable grip <NUM> is rotated in the first direction, the pull member <NUM> is displaced proximally, causing a tension force to be equally or substantially equally applied to all of the individual pull wires <NUM>. Embodiments wherein one or more individual pull wires <NUM> transmit an uneven or larger portion of the tension force are likewise within the scope of this disclosure. The tension force on the pull wires <NUM> results in a tension force being applied to the distal end of the stylet <NUM> and articulation of the distal portion of the bone displacement device <NUM>, as shown in <FIG>. During actuation, the rotatable grip <NUM> may be rotated from about one degree to about <NUM> degrees, from about one degree to about <NUM> degrees, or from about one degree to about <NUM> degrees, or along any portion of these ranges. Rotation of the rotatable grip <NUM> in the first direction may be stopped when the proximal female thread stop <NUM> engages with the proximal male thread stop <NUM>, or may be stopped at any point along the range of rotation of the rotatable grip <NUM>, meaning it is stopped by a user at a point of partial rotation along the rotational range of the rotatable grip <NUM>. Rotation of the rotatable grip <NUM> and proximal displacement of the pull member <NUM> results in an articulation of the distal portion of the bone displacement device <NUM> from about zero degrees to about <NUM> degrees, from about zero degrees to about <NUM> degrees, or from about zero degrees to about <NUM> degrees. In some embodiments, the rotatable grip <NUM> may comprise a rotation lock configured to maintain the rotatable grip <NUM> in a partial or fully rotated state when the rotatable grip <NUM> is released by the user. For example, the body <NUM> may comprise teeth configured to engage with opposing teeth of the rotatable grip <NUM>.

Rotation of the rotatable grip <NUM> in the second direction may displace the pull member <NUM> distally and release the tension force on the pull wires <NUM>, resulting in the distal portion of the bone displacement device <NUM> returning to a straight configuration, as shown in <FIG>. The rotatable grip <NUM> can be rotated in the second direction until the distal female thread stop <NUM> engages with the distal male thread stop <NUM>.

<FIG> illustrate a distal portion of the bone displacement device <NUM>. The distal portion comprises the expandable member <NUM>, a distal portion <NUM> of the outer tube <NUM>, a distal portion <NUM> of the inner tube <NUM>, and a distal portion <NUM> of the shaft <NUM>. The inner tube <NUM> and the shaft <NUM> may extend beyond a distal end of the outer tube <NUM>. The inner tube <NUM> may extend beyond a distal end of the shaft <NUM>. According to the invention, the expandable member <NUM> comprises a balloon <NUM>. In other examples, the expandable member <NUM> may comprise any suitable expandable and retractable mechanism. For example, the expandable member <NUM> may comprise a plurality of ribs configured to expand radially outward.

The balloon <NUM> may comprise a double balloon wall <NUM> configured to expand radially outward without stretching when air or fluid is injected into the balloon <NUM>, for example, through the annular space <NUM>. Embodiments wherein the balloon wall comprises more or fewer layers are likewise within the scope of this disclosure. A thickness of the double balloon wall <NUM> may range from about <NUM> to about <NUM> or from about. <NUM> to about <NUM>. A length of the balloon <NUM> when not inflated or expanded may range from about <NUM> to about <NUM>. The balloon <NUM> may be formed of any suitable non-compliant polymeric material, such as engineered plastic polyurethane (e.g., Isoplast®), nylon, polybutylene terephthalate, etc. A proximal portion of the balloon <NUM> may be sealingly coupled to the distal end of the outer tube <NUM>. A tie layer <NUM> may be disposed between the balloon wall <NUM> and the outer tube <NUM> to facilitate bonding of the balloon wall <NUM> to the outer tube <NUM>. In other embodiments, the tie layer <NUM> is not used to facilitate bonding of the balloon wall <NUM> to the outer tube <NUM>. The tie layer <NUM> may be formed from a polyurethane material having an intermediate hardness that is between the hardness of the material of the balloon <NUM> and the hardness of the material of the outer tube <NUM>. The balloon wall <NUM> may be bonded to the tie layer <NUM> and the outer tube <NUM> using any suitable technique, such as heat, radio frequency, solvent bonding, gluing, etc..

A distal portion of the balloon <NUM> may be sealingly coupled to the distal end of the inner tube <NUM>. A tip tie tube <NUM> may be disposed between the balloon wall <NUM> and the inner tube <NUM>. The tip tie tube <NUM> may be formed from a material similar to the tie layer <NUM>. In some embodiments, the tip tie tube <NUM> may comprise a braided structure. The tip tie tube <NUM> may extend proximally over the distal portion <NUM> of the inner tube <NUM> and the distal portion <NUM> of the shaft <NUM>. The tip tie tube <NUM> and shaft <NUM> is configured in a "piston/cylinder" type arrangements where the shaft <NUM> is allowed to move with respect to the tip tie tube when the balloon <NUM> is inflated or deflated. For example, the tip tie tube <NUM> may be configured to piston proximally over the shaft <NUM> when the balloon <NUM> is inflated and to piston distally over the shaft <NUM> when the balloon <NUM> is deflated. The tip tie tube <NUM> may be configured to facilitate bonding of the balloon wall <NUM> to the inner tube <NUM>. In other embodiments, the tip tie tube <NUM> may provide structural support to the inner tube <NUM> to prevent kinking of the inner tube <NUM> when inserted into a vertebral bone.

The seal of the proximal end of the balloon <NUM> to the outer tube <NUM> and the seal of the distal end of the balloon <NUM> to the inner tube <NUM> may form a balloon chamber <NUM> configured to be pressurized. The balloon chamber <NUM> may be pressurized up to a pressure of about <NUM> atm. The balloon <NUM> may be expanded to a diameter of from about <NUM> to about <NUM>.

As shown in <FIG>, the distal portion <NUM> of the shaft <NUM> may comprise a plurality of laser cuts <NUM> (not claimed). The laser cuts <NUM> may facilitate articulation of the shaft <NUM> in a single plane when the tension force is applied to the pull wires <NUM>, as shown in <FIG>. The laser cuts <NUM> may comprise variables (e.g., depth, pitch, spacing) that control the articulation parameters of the shaft <NUM>, such as angle of articulation. In certain examples, the laser cuts <NUM> may comprise a tab configured to be received by a recess. The laser cuts <NUM> of this example may prevent torsional rotation of the laser cuts <NUM> relative to one another. The pull wires <NUM> may also prevent torsional rotation of the laser cuts <NUM> because the pull wires <NUM> substantially fill the shaft lumen <NUM> preventing axial misalignment of the laser cuts <NUM>. The laser cuts <NUM> may extend partially through a diameter of the shaft <NUM>, leaving a spine of uncut material. When articulated, the shaft <NUM> may bend toward the spine while a distance between shaft segments on either side of the laser cuts <NUM> increases on an opposing side of the shaft <NUM>, defining a substantially "V" shape.

During use, in some instances, the shaft <NUM> may break at one of the laser cuts <NUM> when the shaft <NUM> is articulated. This may be due to external forces (such as from the bone) acting on the shaft <NUM>. In the event of a breakage, the pull wires <NUM> may prevent a portion of the shaft <NUM> distal to the break from breaking away from a remainder of the shaft <NUM>. Even if one of the individual pull wires <NUM> also breaks, the remaining individual pull wires <NUM> may retain attachment to the distal end of the shaft <NUM>. Furthermore, embodiments wherein the pull wires <NUM> collectively fill the shaft lumen <NUM>, even in an event of a break in the shaft <NUM>, the pull wires <NUM> may maintain the coaxial arrangement of the shaft <NUM>, inner tube <NUM>, and outer tube <NUM> and prevent leakage of air or fluid from the bone displacement device <NUM> caused by damage to the inner tube <NUM> and/or outer tube <NUM> by a broken end of the shaft <NUM> of a pull wire <NUM>.

In use, a bone displacement device may be used to displace bone tissue. A distal end of the bone displacement device may be inserted into a vertebral bone, for example, through an introducer cannula. A distal portion of the bone displacement device may be articulated when a rotatable grip is rotated in a first direction, causing one or more pull members to be displaced proximally. Proximal displacement of the pull member may apply a tension force to pull wires disposed within a stylet shaft and coupled to the pull member. The tension force applied to the pull wires can cause a distal portion of a stylet to articulate the distal portion of the bone displacement device. The articulated bone displacement device can be directed to a desired location within the vertebral bone. A syringe may be coupled to a side port of a handle. Air or fluid may be delivered through the side port to an expandable member (e.g., balloon) disposed adjacent the distal end of the bone displacement device. The air or fluid may expand the expandable member to displace adjacent bone tissue.

<FIG> depict an embodiment of a bone displacement device <NUM> that resembles the bone displacement device <NUM> described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digit incremented to "<NUM>. " For example, the embodiment depicted in <FIG> includes a handle <NUM> that may, in some respects, resemble the handle <NUM> of <FIG>. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the bone displacement device <NUM> and related components shown in <FIG> may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the bone displacement device <NUM> and related components depicted in <FIG>. Any suitable combination of the features, and variations of the same, described with respect to the bone displacement device <NUM> and related components illustrated in <FIG> can be employed with the bone displacement device <NUM> and related components of <FIG>, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

<FIG> depict another embodiment of a bone displacement device <NUM>. In the illustrated embodiment of <FIG>, the bone displacement device <NUM> comprises a handle <NUM>, a catheter <NUM>, a stylet <NUM>, and an expandable member <NUM>. <FIG> shows the bone displacement device <NUM> in a ready state where the expandable member <NUM> is not expanded and a distal portion of the bone displacement device <NUM> is substantially straight. <FIG> shows the bone displacement device <NUM> in a cavity forming state where the expandable member <NUM> is expanded and the distal portion is articulated.

<FIG> illustrates a proximal portion of the bone displacement device <NUM>. The proximal portion comprises the handle <NUM>, a proximal portion of the catheter <NUM>, and a proximal portion of the stylet <NUM>. The catheter <NUM> may comprise an elongate outer tube <NUM> having a proximal portion <NUM>. A proximal end of the outer tube <NUM> can be fixedly coupled to the handle <NUM>.

The stylet <NUM> is shown to comprise a tubular shaft <NUM> having a proximal portion <NUM>. A proximal end of the shaft <NUM> is fixedly coupled to the handle <NUM> at a location proximal of the proximal end of the outer tube <NUM>. A plurality of pull wires <NUM> is disposed within the shaft <NUM>.

<FIG> illustrates a transverse cross-section of a middle portion of the bone displacement device <NUM>. As illustrated, the outer tube <NUM> includes an outer lumen <NUM>. The shaft <NUM> is coaxially disposed within the outer lumen <NUM>. An annular space <NUM> may be formed between the outer tube <NUM> and the shaft <NUM>. The shaft <NUM> includes a shaft lumen <NUM>. The pull wires <NUM> are disposed within the shaft lumen <NUM>.

Referring again to <FIG>, the handle <NUM> comprises a body <NUM> and a rotatable grip <NUM> rotatably coupled to a proximal end of the body <NUM>. The body <NUM> may comprise a side port <NUM> extending laterally from a longitudinal axis of the body <NUM>. The side port <NUM> may be in fluid communication with the annular space (<NUM> of <FIG>). A fluid delivery device (e.g., syringe) can be releasably coupled to a proximal portion of the side port <NUM>. A valve member <NUM> may be disposed within the side port <NUM>. The valve member <NUM> may be configured to selectively permit air or fluid to be directed through the side port <NUM>, through the annular space <NUM>, and to the expandable member <NUM> when the fluid delivery device is coupled to the side port <NUM>. The valve member <NUM> may also be configured to retain the air or fluid within the annular space <NUM> and the expandable member <NUM> when the fluid delivery device is removed from the side port <NUM>.

In the illustrated embodiment, the proximal end of the outer tube <NUM> is coupled to the body <NUM> at a location distal to the side port <NUM>. The shaft <NUM> can be coupled to the body <NUM> at a location proximal to the outer tube <NUM>.

The rotatable grip <NUM> may be configured to be rotatable around a longitudinal axis of the handle <NUM>. The rotatable grip <NUM> may comprise generally laterally and proximally extending wings <NUM> configured to be gripped by a user. The rotatable grip <NUM> may comprise a chamber <NUM> configured to receive a pull member <NUM>. The chamber <NUM> may include a female thread <NUM> configured to engage a male thread <NUM> of the pull member <NUM>. The female thread <NUM> may comprise proximal and distal thread stops <NUM>. The male thread <NUM> may comprise proximal and distal thread stops <NUM>. The female thread stops <NUM> can be configured to engage with the male thread stops <NUM> to prevent over-rotation of the rotatable grip <NUM> in both a first direction and a second direction.

In the illustrated embodiment, the proximal ends of the pull wires <NUM> are fixedly coupled to the pull member <NUM>. When the rotatable grip <NUM> is rotated in the first direction, the pull member <NUM> can be displaced proximally, causing a tension force to be applied to the pull wires <NUM>. The tension force on the pull wires <NUM> results in a tension force being applied to the distal end of the shaft <NUM> and articulation of the shaft <NUM> and the bone displacement device <NUM>, as shown in <FIG>.

Rotation of the rotatable grip <NUM> in the second direction displaces the pull member <NUM> distally and release the tension force on the pull wires <NUM>, resulting in the distal portion of the bone displacement device <NUM> returning to a substantially straight configuration, as shown in <FIG>. The rotatable grip <NUM> can be rotated in the second direction until the distal female thread stop <NUM> engages with the distal male thread stop <NUM>.

<FIG> illustrate a distal portion of the bone displacement device <NUM>. The distal portion comprises an expandable member <NUM>, a distal portion <NUM> of the outer tube <NUM>, and a distal portion <NUM> of the shaft <NUM>. The shaft <NUM> may extend beyond the distal end of the outer tube <NUM>. According to the invention, the expandable member <NUM> comprises a balloon <NUM>.

The balloon <NUM> may comprise a balloon wall, such as a double balloon wall <NUM> configured to expand radially outward without stretching when air or fluid is injected into the balloon <NUM> through the annular space <NUM>. A proximal portion of the balloon <NUM> may be sealingly coupled to the distal end of the outer tube <NUM>. A tie layer <NUM> may be disposed between the balloon wall <NUM> and the outer tube <NUM> to facilitate bonding of the balloon wall <NUM> to the outer tube <NUM>.

A distal portion of the balloon <NUM> is sealingly coupled to a distal end of a tip tie tube <NUM>. The tip tie tube <NUM> extends proximally over the distal portion <NUM> of the shaft <NUM>. The tip tie tube <NUM> and shaft <NUM> is configured in a "piston/cylinder" type arrangements where the shaft <NUM> is allowed to move with respect to the tip tie tube when the balloon <NUM> is inflated or deflated. For example, the tip tie tube <NUM> may be configured to piston proximally over the shaft <NUM> when the balloon <NUM> is inflated and to piston distally over the shaft <NUM> when the balloon <NUM> is deflated. A plug <NUM> is sealingly disposed within the distal end of the tip tie tube <NUM>.

The seal of the proximal end of the balloon <NUM> to the outer tube <NUM> and the seal of the distal end of the balloon <NUM> to the tip tie tube <NUM> may form a balloon chamber <NUM> configured to be pressurized. The balloon chamber <NUM> may be pressurized up to a pressure of about <NUM> atm. The balloon <NUM> may be expanded to a diameter of from about <NUM> to about <NUM>.

As shown in <FIG>, the distal portion of the shaft <NUM> may comprise a plurality of laser cuts <NUM>. <NUM> (not claimed). The laser cuts <NUM> may facilitate articulation of the shaft <NUM> when the tension force is applied to the pull wires <NUM>, as shown in <FIG>.

<FIG> depict an example of a bone displacement device <NUM>, not forming part of the invention. In the illustrated example, the bone displacement device <NUM> is partially composed of a handle <NUM>, a catheter <NUM>, a stylet <NUM>, and an expandable member <NUM>. <FIG> shows the bone displacement device <NUM> in a ready state where the expandable member <NUM> is not expanded and a distal portion of the bone displacement device <NUM> is substantially straight. <FIG> shows the bone displacement device <NUM> in a cavity forming state where the expandable member <NUM> is expanded and the distal portion is substantially straight.

<FIG> illustrates a proximal portion of the bone displacement device <NUM>. The proximal portion may comprise the handle <NUM>, a proximal portion of the catheter <NUM>, and a proximal portion of the stylet <NUM>. The catheter <NUM> may comprise an elongate outer tube <NUM> and an elongate inner tube <NUM>. A proximal end of outer tube <NUM> can be coupled to the handle <NUM>. The inner tube <NUM> may be coaxially disposed within the outer tube <NUM>. A proximal end of the inner tube <NUM> can be coupled to the handle <NUM> at a location proximal of the proximal end of the outer tube <NUM>.

The handle <NUM> may comprise a body <NUM>. The body <NUM> may comprise a side port <NUM> extending laterally from a longitudinal axis of the body <NUM>. The side port <NUM> may be in fluid communication with an annular space (<NUM> of <FIG>). A fluid delivery device (e.g., syringe) can be releasably coupled to a proximal portion of the side port <NUM>. A valve member <NUM> may be disposed within the side port <NUM>. The valve member <NUM> may be configured to selectively permit air or fluid to be directed through the side port <NUM>, through the annular space <NUM>, and to the expandable member <NUM> when the fluid delivery device is coupled to the side port <NUM>. The valve member <NUM> may also be configured to retain the air or fluid within the annular space <NUM> and the expandable member <NUM> when the fluid delivery device is removed from the side port <NUM>. The body <NUM> may include a proximal port <NUM> in fluid communication with the inner tube <NUM>. The proximal port <NUM> may be configured to receive the stylet <NUM>. In one example, the proximal port <NUM> may include a female luer taper and a thread engagement feature.

In the illustrated example, the proximal end of the outer tube <NUM> can be coupled to the body <NUM> at a location distal to the side port <NUM>. The inner tube <NUM> can be coupled to the body <NUM> at a location proximal to the outer tube <NUM>.

<FIG> depicts the stylet <NUM>. The stylet <NUM> may comprise a shaft <NUM> and a connector <NUM>. The shaft <NUM> may be a cylindrical rod. In other examples, the shaft <NUM> may be a cylindrical tube. A proximal end of the shaft <NUM> may be fixedly coupled to the connector <NUM>. In the illustrated example, the connector <NUM> is a male luer nut. The connector <NUM> may be configured to be removably coupled to the proximal port <NUM> such that the stylet <NUM> may be inserted into and removed from the bone displacement device <NUM> through the proximal port <NUM>.

<FIG> illustrates a transverse cross-section of a middle portion of the bone displacement device <NUM>. As illustrated, the outer tube <NUM> includes an outer lumen <NUM>. The inner tube <NUM> is shown to be coaxially disposed within the outer lumen <NUM>. An annular space <NUM> may be defined between the outer tube <NUM> and the inner tube <NUM>. The inner tube may include an inner lumen <NUM>. The shaft <NUM> may be coaxially disposed within the inner lumen <NUM>.

<FIG> illustrate a distal portion of the bone displacement device <NUM>. The distal portion may comprise an expandable member <NUM>, a distal portion <NUM> of the outer tube <NUM>, a distal portion <NUM> of the inner tube <NUM>, and a distal portion <NUM> of the shaft <NUM>. The inner tube <NUM> and the shaft <NUM> may extend beyond the distal end of the outer tube <NUM>. The inner tube <NUM> may extend beyond the distal end of the shaft <NUM>. In the illustrated example, the expandable member <NUM> comprises a balloon <NUM>.

A proximal portion of the balloon <NUM> may be sealingly coupled to the distal end of the outer tube <NUM>. A tie layer <NUM> may be disposed between a balloon wall <NUM> and the outer tube <NUM> to facilitate bonding of the balloon wall <NUM> to the outer tube <NUM>. A distal portion of the balloon <NUM> may be sealingly coupled to the distal end of the inner tube <NUM>. A tip tie tube <NUM> may be disposed between the balloon wall <NUM> and the inner tube <NUM>. The tip tie tube <NUM> may extend proximally over the distal portion <NUM> of the inner tube <NUM> and the distal portion <NUM> of the shaft <NUM>. The tip tie tube <NUM> and shaft <NUM> may be configured to move in a piston/cylinder configuration when the balloon <NUM> is inflated and deflated. For example, the tip tie tube <NUM> may move proximally over the shaft <NUM> when the balloon <NUM> is inflated, as shown in <FIG>, and to piston distally over the shaft <NUM> when the balloon <NUM> is deflated, as shown in <FIG>.

<FIG> depict another embodiment of a bone displacement device <NUM>. In the illustrated embodiment, the bone displacement device <NUM> comprises a handle <NUM>, a catheter <NUM>, a stylet <NUM>, an expandable member <NUM>, and a protective sleeve <NUM>. <FIG> shows the bone displacement device <NUM> in a package state where the protective sleeve <NUM> surrounds the expandable member <NUM>. <FIG> shows the bone displacement device <NUM> in a ready state where the protective sleeve <NUM> is displaced proximally over the catheter <NUM> and releasably coupled to the handle <NUM>.

In the depicted embodiment, the protective sleeve <NUM> may include a tubular body <NUM> and a grip <NUM> coupled to the tubular body <NUM>. A distal end <NUM> of the tubular body <NUM> may be formed in a funnel shape to facilitate passage of the protective sleeve <NUM> distally over the expandable member <NUM> when not expanded. A proximal end of the tubular body <NUM> may be sized to be releasably received into a recess <NUM> disposed at a distal end of a body <NUM> of the handle <NUM>, as shown in <FIG>. In other embodiments, the proximal end of the tubular body <NUM> may be sized to fit over a protrusion extending from the distal end of the body <NUM>.

As depicted in the illustrated embodiment, the grip <NUM> has an oval shape. In other embodiments, the grip <NUM> may have any suitable shape that is grippable with fingers of a user. For example, the grip <NUM> may have a rectangular, square, circular, or triangular shape, etc. In some embodiments, the grip <NUM> may include grip enhancing features, such as ridges, bumps, recesses, etc. In another embodiment, the grip <NUM> may include indicia (e.g., an arrow) to indicate the direction the protective sleeve <NUM> could be moved prior to use of the bone displacement device <NUM>.

The protective sleeve <NUM> may be disposed over the expandable member <NUM> during a manufacturing assembly of and prior to packaging of the bone displacement device <NUM>. In preparation for a treatment procedure, a user can remove the bone displacement device <NUM> from its package in the package state, as shown in <FIG>, where the protective sleeve <NUM> is disposed over the expandable member <NUM>. The user may then proximally displace the protective sleeve <NUM> and releaseably couple the protective sleeve <NUM> to the handle <NUM>, as shown in <FIG>, prior to insertion of the bone displacement device <NUM> into a vertebral bone of a patient to prevent the protective sleeve <NUM> from inadvertent distal displacement into a working field. In some procedures, upon removal of the bone displacement device <NUM> from the vertebral bone, the user may longitudinally distally displace the protective sleeve <NUM> to rewrap (e.g., radially compress) the expandable member <NUM> in preparation for re-insertion of the bone displacement device <NUM>.

Claim 1:
A bone displacement device (<NUM>), comprising:
an elongate outer tube (<NUM>);
an elongate stylet (<NUM>) coaxially disposed within the outer tube (<NUM>), wherein the stylet (<NUM>) comprises a tubular shaft (<NUM>) and a plurality of pull wires (<NUM>) disposed within the shaft (<NUM>), the plurality of pull wires (<NUM>) are configured to be pulled proximally;
a handle (<NUM>) coupled to a proximal portion of the outer tube and the stylet wherein the handle (<NUM>) comprises a rotatable grip (<NUM>), and wherein the plurality of pull wires (<NUM>) are coupled to a pull member (<NUM>) disposed within the rotatable grip (<NUM>), and wherein the rotatable grip (<NUM>) engages with threads of the pull member (<NUM>) to displace the pull member (<NUM>) proximally and distally, wherein the pull member (<NUM>) is displaced proximally when the rotatable grip (<NUM>) is rotated in a first direction to apply a tension force to the plurality of pull wires (<NUM>), and displaced distally when the rotatable grip (<NUM>) is rotated in a second direction to release the tension force from the plurality of pull wires (<NUM>), and wherein a distal portion of the stylet (<NUM>) articulates when the tension force is applied to the plurality of pull wires (<NUM>);
a balloon (<NUM>) disposed adjacent a distal end of the outer tube (<NUM>);
a tip tie tube (<NUM>) disposed within the balloon (<NUM>) and coupled to a distal end of the balloon (<NUM>) and slidably disposed over a distal portion of the stylet (<NUM>) , wherein the tip tie tube (<NUM>) is displaced proximally relative to the distal portion of the stylet (<NUM>) when the balloon (<NUM>) is expanded, and is displaced distally relative to the distal portion of the stylet (<NUM>) when the balloon (<NUM>) is contracted; and
a plug (<NUM>) sealingly disposed within a distal end of the tip tie tube (<NUM>).