Patent Description:
Degenerative disc diseases are common disorders that can impact all or a portion of a vertebral disc, a cushion-like structure located between the vertebral bodies of the spine. Degenerative disc diseases may lead, for example, to a disc herniation where the vertebral disc bulges out or extrudes beyond the usual margins of the disc and the spine. Disc herniation, in particular, is believed to be the result of excessive loading on the disc in combination with weakening of the annulus due to such factors as aging and genetics. Such degenerative disc diseases are also associated with spinal stenosis, a narrowing of the bony and ligamentous structures of the spine. Although disc herniation can occur anywhere along the perimeter of the disc, it occurs more frequently in the posterior and posterior-lateral regions of the disc, where the spinal cord and spinal nerve roots reside. Compression of these neural structures can lead to pain, parasthesias, weakness, urine and fecal incontinence and other neurological symptoms that can substantially impact basic daily activities and quality of life.

Temporary relief of the pain associated with disc herniation, or other degenerative disc diseases, is often sought through conservative therapy, which includes positional therapy (e.g. sitting or bending forward to reduce pressure on the spine), physical therapy, and drug therapy to reduce pain and inflammation. When conservative therapy fails to resolve a patient's symptoms, surgery may be considered to treat the structural source of the symptoms. When surgery fails to resolve a patient's symptoms, more drastic measures may include disc replacement surgery or vertebral fusion.

There are numerous implantable devices that have been developed for disc replacement and vertebral fusion. Such implantable devices, also referred to as cage systems, may be deployed to replace the vertebral disc and fuse the adjacent vertebrae, relieving pain and providing increased mobility to the patient. However, known implantable devices and methodologies have drawbacks. For example, many of the implantable devices currently available do not allow for an ample amount of materials to encourage bone growth to be positioned within and around the devices and adjacent vertebral bones. Such gone growth materials allow for a higher level of fusion of the adjacent vertebrae, providing increase stabilization and minimize the likelihood of further issues in the future. Also, many implantable devices are large structures that are not easily utilized in a minimally invasive procedure. Rather, they may require surgical procedures allowing greater access, which subjects the patient to higher risks of disease and prolonged infection.

There is a need for implantable devices intended for replacement of a vertebral disc, which allow for ample placement of bone growth material that may lead to better fusion between adjacent vertebral bones. There is a further need for such implantable devices to be provided during minimally invasive procedures, reducing the risk of infection and allowing for quicker healing of the patient.

<CIT> discloses an implantable orthopedic device having a longitudinal axis comprising: a first plate having a longitudinal axis having a radius of curvature less than about <NUM>; a second plate opposite to the first plate; a first wedge between the first plate and the second plate at a first longitudinal end of the device; and a second wedge between the first plate and the second plate at a second longitudinal end of the device. The first plate has a first extension extending in the direction of the second plate and the second plate has a first receiver configured to slidably receive the first extension. The first wedge is longitudinally translatable toward the second wedge and the first extension slides.

<CIT> discloses An expandable implant device comprising a first load-bearing element, a second load-bearing element and a sliding element slidably attached to the first load-bearing element and the second load-bearing element. The sliding element has first, second and third sliding element ramps positioned substantially evenly distributed along the length of the sliding element, and the first load-bearing element has first, second and third load-bearing ramp features. The first, second and third sliding element ramp features are configured to press against the first, second and third load-bearing ramp features, respectively, when the sliding element is translated with respect to the first load-bearing element. Translation of the sliding element with respect to the first load-bearing element causes the first load-bearing element to move away from the second load-bearing element.

According to the present invention there is provided the intervertebral device of claim <NUM>. Additional aspects of the invention are set out in the dependent claims.

Consistent with the present disclosure, an expandable intervertebral device may comprise a base including a bottom surface configured to interface with a first biological tissue, a first body portion slidably attached to the base and configured to move in at least a first direction with respect to the base, the first body portion including a first engaging element, and a second body portion slidably attached to the base and configured to move in at least a second direction with respect to the base. The second body portion may include a top surface configured to interface with a second biological tissue. The base may include a second engaging element such that the second engaging element couples to the first engaging element. In certain embodiments, the first and second engaging elements are configured such that the coupling of the first and second engaging elements prevents movement of the second body portion in a third direction with respect to the base when a compression force is applied between the top surface of the second body portion and the bottom surface of the base. In other embodiments, the third direction is substantially opposite to the first direction, while in still other embodiments, the third direction is substantially opposite to the first direction.

In yet other embodiments, the first body portion may include a first sloped surface and the second body portion may include a second sloped surface. The first sloped surface may be configured to slidably couple with the second sloped surface, such that movement of the first body portion in the first direction results in movement of the second body portion in the second direction. The first sloped surface of the first body portion may form a first acute angle with respect to a longitudinal axis of the base, and the second sloped surface of the second body portion may form a second acute with respect to the longitudinal axis of the base. In some embodiments, the first acute angle is substantially equal to the second acute angle, while in other embodiments the first acute angle is different than the second acute angle. In still other embodiments, the first sloped surface of the first body portion may form a first acute angle with respect to a longitudinal axis of the base, and the second sloped surface of the second body portion may form a second acute with respect to the longitudinal axis of the base. Movement of the second body portion relative to the first body portion may define a movement rate, the first and second acute angles may be selected to provide the movement rate.

In certain embodiments, the first body portion may be configured to be removably attached to a translating member, where operation of the translating member results in movement of the first body portion in the first direction, generally along a longitudinal axis of the base. In some embodiments, the base includes a longitudinal axis, and the first direction is substantially parallel to the longitudinal axis of the base, while in other embodiments, the base includes a longitudinal axis, the second direction being substantially perpendicular to the longitudinal axis of the base. In other embodiments, the first direction and the second direction are substantially perpendicular.

In still other embodiments, the base includes first and second ends, and a longitudinal axis extending from the first end to the second end, and each of a plurality of positions of the first body portion along the longitudinal axis of the base corresponding to a respective one of a plurality of positions of the second body portion. Each of the plurality of positions of the first body portion may correspond to a respective one of a plurality of heights of the intervertebral device.

In yet other embodiments, the first direction is in a direction toward a distal end of the device along a longitudinal axis of the base, while in other embodiments the first direction is in a direction toward a proximal end of the device along a longitudinal axis of the base.

In another aspect, a method includes providing an intervertebral device having a base, a first body portion, and a second body portion, the first body portion configured to move in at least a first direction with respect to the base and the second body portion configured to move in at least a second direction with respect to the base, the first body portion including a first engaging element and the base portion including a second engaging element;.

moving the first body portion in the first direction, the second body portion moving in the second direction in response to movement of the first body portion, the first engaging element of the first body portion couples to the second engaging element of the base, the coupling of the first and second engaging elements preventing movement of the second body portion in a third direction.

In certain embodiments, the base, and the first and second body portions form a void, movement of the first body portion in the first direction results in increasing an area of the void. The method may include deploying one or more therapeutic agents within the void, the therapeutic agents including a substance to encourage bone growth, for example. A central axis of each of the base, and first and second body portions may pass through the void.

In other embodiments, moving the first element in the first direction results in adjusting the height of the intervertebral device. Adjusting the height may include expanding and contracting the intervertebral device.

In yet other embodiments, the first direction is in a direction toward a distal end of the device along a longitudinal axis of the base, while in other embodiments, the first direction is in a direction toward a proximal end of the device along a longitudinal axis of the base.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the any embodiments, as claimed. Other objects, features and advantages of the embodiments disclosed or contemplated herein will be apparent from the drawings, and from the detailed description that follows below.

Reference will be made to embodiments of the disclosure, examples of which may be illustrated in the accompanying figures. These figures are intended to be illustrative, not limiting. Although certain aspects of the embodiments are generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope to these particular embodiments. In the drawings:.

Intervertebral devices and systems, and methods (not claimed) of their use, are disclosed having configurations suitable for placement between two adjacent vertebrae, replacing the functionality of the disc therebetween. Intervertebral devices and systems contemplated herein are implantable devices intended for replacement of a vertebral disc, which may have deteriorated due to disease for example. The intervertebral devices and systems are configured to allow for ample placement of therapeutic agents therein, including bone growth enhancement material, which may lead to better fusion between adjacent vertebral bones. The intervertebral devices and systems are configured for use in minimally invasive procedures, if desired.

The following description is set forth for the purpose of explanation in order to provide an understanding of the various embodiments of the present disclosure. However, it is apparent that one skilled in the art will recognize that embodiments of the present disclosure may be incorporated into a number of different systems and devices.

The embodiments of the present disclosure may include certain aspects each of which may be present in one or more medical devices or systems thereof. Structures and devices shown below in cross-section or in block diagram are not necessarily to scale and are illustrative of exemplary embodiments. Furthermore, the illustrated exemplary embodiments disclosed or contemplated herein may include more or less structures than depicted and are not intended to be limited to the specific depicted structures. While various portions of the present disclosure are described relative to specific structures or processes with respect to a medical device or system using specific labels, such as "locked" or "therapeutic agents", these labels are not meant to be limiting.

The expandable intervertebral devices described herein may be made from any suitable biocompatible material, including but not limited to metals, metal alloys (e.g. stainless steel) and polymers (e.g. polycarbonate), and may be formed using any appropriate process, such as screw-machining or molding (e.g. injection molding). The intervertebral devices herein may be sized for minimally invasive procedures having operating lumens at about <NUM> or less. For illustration purposes only, any expandable intervertebral device described or contemplated herein may have a height in the range from about <NUM> to about <NUM>, and a length in the range of from about <NUM> to about <NUM>, and a width in the range of from about <NUM> to about <NUM>. The intervertebral devices described or contemplated herein may be positioned between adjacent vertebrae through any suitable procedure, such as through a posterior lumbar interbody approach or through a transforaminal lumbar interbody approach, for example.

Reference will now be made in detail to the present exemplary embodiments, which are illustrated in the accompanying drawings.

Turning to <FIG>, a perspective view of an exemplary intervertebral device <NUM> includes a first element or base element <NUM>, a second or sliding element <NUM>, a third or elevating element <NUM>, and a drive mechanism <NUM>. As will be better understood in the discussion below, the elements <NUM>, <NUM>, <NUM> cooperate such that the intervertebral device <NUM> geometric height, H, may have a minimum, collapsed configuration, as generally depicted in <FIG>, or a maximum, expanded configuration, as generally depicted in <FIG>, or any height therebetween, as discussed in greater detail below. As will be better understood in light of the discussion below, the elements <NUM>, <NUM>, <NUM> include protrusions and depressions that cooperate to allow coordinated movement of each of the element <NUM>, <NUM>, <NUM> with respect to each other. For example, as the second element <NUM> translates from a proximal position to a distal position within the first element <NUM>, protrusions and depressions of the elements <NUM>, <NUM>, <NUM> cooperate resulting in the elevation of the third element <NUM> with respect to the first and second elements <NUM>, <NUM>.

The first element <NUM> is configured to provide a base or outer structure for the intervertebral device <NUM>, retaining the remaining elements <NUM>, <NUM> therein. The first element <NUM> includes a first or proximal end <NUM> and a second or distal end <NUM> and two side portions, a first side portion <NUM> and an opposing side portion <NUM>. A bottom portion <NUM> of the first element <NUM> may include one or more openings <NUM> to allow for therapeutic materials, such as bone growth enhancing materials, to pass therethrough. As used herein, the term "therapeutic materials" or therapeutic agents" may include any substance, including bone growth materials or drug eluding materials for example, or a product or medical device including or deploying such substances, intended for use in the medical diagnosis, cure, treatment, or prevention of disease.

Proximal end <NUM> of the first element <NUM> may include an opening <NUM> for passing a portion of one or more tools utilized for expanding, contracting, or locking the intervertebral device <NUM> in a specific configuration, as is discussed in greater detail below with reference to <FIG>. For example, the intervertebral device <NUM> may be expanded from a first position or configuration, having a height of H<NUM>-<NUM>, as depicted in <FIG>, to a second position or configuration, having a height of H<NUM>-<NUM>, as depicted in <FIG>, or any suitable height therebetween, and locked in any such configuration or at any such height. As used herein, the term "lock", "locked" or "locking" used in conjunction with the intervertebral device <NUM>, or any other intervertebral device described or contemplated herein, shall mean to substantially maintain the position of each of the main elements, such as elements <NUM>, <NUM>, <NUM>, with respect to each other. A void or space <NUM> is defined by the elements <NUM>, <NUM>, <NUM> when the intervertebral device <NUM> takes on a collapsed configured, as depicted in <FIG>, and the void or space <NUM> increases when the intervertebral device <NUM> takes on an expanded configuration, as depicted in <FIG>. Therapeutic Agents may then be deployed through opening <NUM>, or other suitable opening, to fill the void <NUM> and expand out of the intervertebral device <NUM> to engage surrounding tissue, e.g. tissue of the vertebra.

The proximal end <NUM> of the first element <NUM> may also include structures, such as a threaded structure 130T, as better shown in <FIG>, and recesses <NUM>, which may allow for an attachment point of one or more delivery systems, as described in greater detail below with respect to <FIG>. Such attachment point may also form the basis for at least initially positioning the intervertebral device <NUM>, for example between two adjacent vertebrae of a spine. In other embodiments, the delivery system utilized may include tubular members through which therapeutic materials, including bone growth enhancing materials, may be introduced, for example, to internal voids or spaces within the intervertebral device <NUM>, and exiting through the one or more openings <NUM> of the element <NUM>, or similar openings of the remaining elements <NUM>, <NUM>. In this way, such materials may contact surrounding tissues, such as tissues of the vertebrae.

The internal sidewalls of side portions <NUM>, <NUM> of the first element <NUM> may include one or more protrusions <NUM> and one or more depressions <NUM>, as better viewed with respect to <FIG>. These protrusions <NUM> and depressions <NUM> include surfaces that interface with one or more surfaces of protrusions and depressions of the other elements <NUM>, <NUM> resulting in coordinated movement.

The second element <NUM> is slidably interfaced to the first element <NUM> such that the second element <NUM> at least translates horizontally with respect to the first element <NUM>. Second element <NUM> may include a positioning structure or pin <NUM> that is coupled to the second element <NUM>. The pin <NUM> may be configured or adapted to move within a channel or slot <NUM> provided in the first element <NUM> to ensure that the second element <NUM> moves in a specific direction with respect to the element <NUM>. Accordingly, slot <NUM> and associated structure or pin <NUM> may be configured to form any desirable angle with respect to a longitudinal centerline of element <NUM>. As depicted, slot <NUM> is substantially parallel to a longitudinal line of element <NUM> and, therefore, the element <NUM> moves in a direction substantially perpendicular to element <NUM>. The second element <NUM> may also include one or more openings <NUM> that are in fluid communication with openings of one or more other elements <NUM>, <NUM>, such as openings <NUM> of the first element <NUM>, to allow for passage of therapeutic agents therethrough.

The third element <NUM> includes a top surface <NUM> having one or more openings <NUM> that are in fluid communication with void <NUM>. The top surface may include other structures to enable or encourage contact and retention with respect to a bodily tissue, such as tissue of a vertebra. The third element <NUM> may include one or more side members <NUM>, each having one or more protrusions <NUM> and one or more depressions <NUM> and corresponding surfaces that cooperate with surfaces of the first and second elements <NUM>, <NUM> to allow for cooperative movement.

Turning to <FIG>, which depict the intervertebral device <NUM> in cross-section down a central longitudinal axis, drive mechanism <NUM> includes a retaining cap <NUM> and drive member <NUM>. The drive member <NUM> may include drive points 194D configured to receive a driver for rotational control of the member <NUM>. The retaining cap <NUM> may be fixedly attached to the first element <NUM> to retain the drive member <NUM> within the intervertebral device <NUM> and provide a surface force to allow for the translation of the second element <NUM>. For example, as depicted, the drive member <NUM> may include a proximal drive point 194DP located closer to proximal end <NUM> of the first element <NUM>, and a distal drive point 194DD located closer to distal end <NUM> of the first element <NUM>. As is discussed in greater detail below, a driver may enter through opening <NUM>, pass through void <NUM>, and engage the proximal drive point 194DP, rotation of the driver resulting in corresponding rotation of the driver member <NUM>, for example. The retaining cap <NUM> may include an opening <NUM> for driver access to the distal drive point 194DD, if desired.

The driver member <NUM> includes a helical threaded portion 194T configured or adapted to interface with a helical threaded portion 140T of the second element <NUM>. Accordingly, rotation of the drive member <NUM> results in axial movement of the second member <NUM>. More specifically, if the drive member <NUM> is rotated in a first direction, the second element <NUM> will move in a distal direction, toward distal end <NUM> of the first element <NUM>, and if the drive member <NUM> is rotated in a second opposing direction, the second element <NUM> will move in a proximal direction, toward proximal end <NUM> of the first element <NUM>. Since the threads 194T, 140T are continuous, the second element <NUM> may be positioned at any point along a longitudinal axis of the first element <NUM>, each point along the longitudinal axis corresponding to a respective height of the third element <NUM>.

With specific reference to <FIG>, depicting the intervertebral device <NUM> in cross-section through a central geometric plane, the second element <NUM> includes side members 150A (not shown) and 150B, collectively referred to as side members <NUM>. As depicted, side member 150B includes one or more protrusions <NUM> and one or more depressions <NUM> that interface with other structures of the third element <NUM> such that when the second element <NUM> translates distally the third element <NUM> moves at least vertically, increasing an overall height of the intervertebral device <NUM>. For example, protrusion <NUM> includes a sloped surface <NUM>S1 that interfaces with an adjacent sloped surface 184DS3 of the side member 180D of the third element <NUM>. As the second element <NUM> moves distally, the interaction of these sloped surfaces <NUM>S1, 184DS3 results in the vertical displacement of the third element <NUM>. The third element <NUM> may also interface with sloped surfaces of the first element <NUM> to further encourage this vertical displacement. For example, the first element <NUM> includes a sloped surface <NUM> adjacent to a sloped surface 184DS1 associated with side member 180D, the interaction of the sloped surfaces <NUM>S, 184DS1 further encouraging vertical displacement of the third element <NUM> as the second element <NUM> translates distally within the first element <NUM>.

With reference now to <FIG>, the interaction of first element <NUM> and the third element <NUM> will be described in greater detail. For discussion purposes only, the second element <NUM> has been removed. Additionally, while this discussion considers only a single side member 180D, this discussion also applies to other side members <NUM> of the third element <NUM>. As depicted, side member 180D includes protrusions 184D and depressions 186D, the protrusions 184D defining corresponding surfaces 184DS1-S3. The first element <NUM> includes protrusions 124B and depressions 126B on the inner surface of side portion <NUM>. Protrusion 124B1 includes a surface 124B1S, and protrusion 124B2 includes a first surface 124B2S1 and a second surface 124B2S2, surface 184DS1 interfacing with surface 124B1S and surface 184DS2 interfacing with surface 124B2S1, such that a portion of side member 180D is able to move within and along depression 126B1. Side member 180D also defines a surface 184DS<NUM> that, along with surface 184CS<NUM> of side member 184C, interfaces with corresponding surfaces of second element <NUM>, as discussed below with reference to <FIG>.

Turning to <FIG>, interaction between the geometric features of the second element <NUM> and the third element <NUM> are depicted and, for discussion purposes only, the first element <NUM> has been removed. Additionally, while this discussion considers only a single side portion 150A of the second element <NUM> and its interaction with side members 180A, 180B of the third element <NUM>, this discussion also applies to side portion 150B of the second element <NUM> and its corresponding interaction with side members 180C, 180D of the third element <NUM>. As depicted, side portion 150A includes first and second protrusions 144A1, 144A2, and first and second depressions 146A1, 146A2. The side member 180A of the third element <NUM> includes protrusion 184A having a first side surface 184AS1 and a second side surface 184AS2. The first depression 146A1 of the second element <NUM> includes a first side surface 146A1S1 and a second side surface 146A1S2. The side member 180A of the third element <NUM> is slidably received in the depression 146A1 of the second element <NUM>, the surfaces 184AS1, 184AS2 interfacing with surfaces 146A1S1, 146A1S2, respectively. Accordingly, as the second element <NUM> distally translates in a direction generally depicted by arrow AD, side surface 146A1S1 couples with side surface 184AS1 to move the third element <NUM> at least vertically away from the second element <NUM>. Similarly, as the second element <NUM> proximally translates in a direction generally depicted by arrow AP, side surface 146A1S2 couples with side surface 184AS2 to move the third element <NUM> at least vertically toward the second element <NUM>.

Turning to <FIG>, an exemplary intervertebral device <NUM> includes a first element <NUM>, a second element <NUM>, a third element <NUM>, and a drive mechanism <NUM>. Intervertebral device <NUM> is similar to intervertebral device <NUM>, except the elements <NUM>, <NUM>, <NUM> of the device <NUM> have geometric characteristics that cooperate in such a way as to allow, in operation, the third element <NUM> to move vertically with respect to a longitudinal axis of the first element <NUM>. The various surfaces of the element <NUM>, <NUM>, <NUM> of the device <NUM> cooperated to allow, in operation, the third element <NUM> to move vertically, as well as horizontally, with respect to a longitudinal axis of the first element <NUM>.

Element <NUM> includes a proximal end <NUM> and a distal end <NUM>, and a first side <NUM> and a second side <NUM>. The element <NUM> further includes a bottom portion <NUM> having one or more openings <NUM>. The element <NUM> also includes an opening <NUM> at the proximal end <NUM>, the opening allowing a passageway for medical tools or therapeutic agents to an interior void <NUM> of the device <NUM>. The second element <NUM> is similar to element <NUM>, having geometric structures and surfaces that interface with the third element, to allow for the third element to move vertically with respect to a longitudinal axis of the first element <NUM>. The third element <NUM> has a surface <NUM> adapted to engage a biological tissue surface, the element <NUM> including one or more openings <NUM> in fluid communication with the interior void <NUM> and the one or more openings <NUM> of the bottom surface <NUM> of the first element <NUM>. Third element <NUM> further includes an side member 280B that has vertical surfaces to encourage vertical movement of the third element <NUM> with respect to the first element when operated.

Turning to <FIG>, the intervertebral device <NUM> is depicted in cross-section along a central longitudinal axis. As shown, the device <NUM> includes drive mechanism <NUM> that includes a retaining cap <NUM> and drive member <NUM>, similar to the drive mechanism <NUM> of the intervertebral device <NUM>. The drive member <NUM> may include drive points 294D configured to receive a driver for rotational control of the member <NUM>. The retaining cap <NUM> may be fixedly attached to the first element <NUM> to retain the drive member <NUM> within the intervertebral device <NUM> and provide a surface force to allow for the translation of the second element <NUM>. For example, as depicted, the drive member <NUM> may include a proximal drive point 294DP located closer to proximal end <NUM> of the first element <NUM>, and a distal drive point 294DD located closer to distal end <NUM> of the first element <NUM>. Similar to operation of the drive mechanism <NUM>, a driver may enter through opening <NUM>, pass partially through void <NUM>, and engage the proximal drive point 294Dp, rotation of the driver resulting in corresponding rotation of the driver member <NUM>, for example. The retaining cap <NUM> may include an opening <NUM> for driver access to the distal drive point 294DD, if desired.

The driver member <NUM> includes a helical threaded portion 294T configured or adapted to interface with a helical threaded portion 240T of the second element <NUM>. Accordingly, rotation of the drive member <NUM> results in axial movement of the second member <NUM>. More specifically, if the drive member <NUM> is rotated in a first direction, the second element <NUM> will move in a distal direction, toward distal end <NUM> of the first element <NUM>, and if the drive member <NUM> is rotated in a second opposing direction, the second element <NUM> will move in a proximal direction, toward proximal end <NUM> of the first element <NUM>. Since the threads 294T, 240T are continuous, the second element <NUM> may be positioned at any point along a longitudinal axis of the first element <NUM>, each point along the longitudinal axis corresponding to a respective height of the third element <NUM>.

As shown in <FIG>, the third element <NUM> includes a side member 280D that includes side surfaces which are vertical with respect to a longitudinal axis of the first element <NUM>. The side member 280D, during operation, moves vertically in a corresponding depression 218D in the inner wall service of side <NUM>. Turning to <FIG>, the interaction of the first element <NUM> and the third element <NUM> of the intervertebral device <NUM> is depicted in greater detail, the second element <NUM> removed for discussion purposes only. As shown, the side member 280D is slidably positioned within the depression 218D. Turning also to <FIG>, the interaction between the geometric features of the second element <NUM> and the third element <NUM> are depicted and, for discussion purposes only, the first element <NUM> has been removed. Additionally, while this discussion considers only a single side portion 250A of the second element <NUM> and its interaction with side members 280A, 280B of the third element <NUM>, this discussion also applies to side portion 250B of the second element <NUM> and its corresponding interaction with side members 280C, 280D of the third element <NUM>. As depicted, side portion 250A includes first and second protrusions 244A1, 244A2, and a depression 246A. The side member 280A of the third element <NUM> includes protrusion 284A having a first side surface 284AS1 and a second side surface 284AS2. The depression 246A of the second element <NUM> includes a first side surface 246AS1 and a second side surface 246AS2. The side member 280A of the third element <NUM> is slidably received in the depression 246A of the second element <NUM>, the surfaces 284AS1, 284AS2 interfacing with surfaces 146AS1, 146AS2, respectively. Accordingly, as the second element <NUM> distally translates, as generally depicted by arrow AD, side surface 246AS1 couples with side surface 284AS1 to move the third element <NUM> vertically away from the second element <NUM>. Similarly, as the second element <NUM> proximally translates in a direction generally depicted by arrow AP, side surface 246AS2 couples with side surface 284AS2 to move the third element <NUM> vertically toward the second element <NUM>.

Turning to <FIG>, a third exemplary intervertebral device <NUM> includes a first element <NUM>, a second element <NUM>, a third element <NUM>, and a drive mechanism <NUM>. Intervertebral device <NUM> is similar to devices <NUM> and <NUM>, except as the second element <NUM> translates distally, both the first element <NUM> and the third element <NUM> move vertically away from the second element <NUM>. Turning to <FIG>, the intervertebral device <NUM> is depicted in an expanded configuration. As shown, protrusions <NUM> of the second element <NUM> are configured to be slidably coupled to corresponding depressions <NUM> in the first element <NUM>. Additionally, protrusions <NUM> of side members <NUM> of the third element <NUM> are configured to be slidably coupled to corresponding depressions <NUM> of the second element <NUM>. In a similar fashion as described with respect to the first and second devices <NUM>, <NUM>, as the second element translates distally through operation of the drive mechanism <NUM>, creating or enlarging a void <NUM>, the geometric structures and surfaces of the elements <NUM>, <NUM>, <NUM> cooperate to move both the first element <NUM> and the third element <NUM> vertically away from the second element <NUM>. The configuration of the intervertebral device <NUM> allows for a greater overall height of device <NUM> to be achieved with respect to an initial height. Accordingly, the intervertebral device <NUM> may be initially sized to be delivered through minimally invasive means, e.g. positioned through an endoscopic approach. Once positioned the intervertebral device <NUM> may then be expanded to a desired height. Turning to <FIG>, with the device <NUM> in an expanded configuration and due to the specific design of the geometric structures of the elements <NUM>, <NUM>, <NUM>, a large void <NUM> can be achieved. This void <NUM> can then be filled with therapeutic agents, to encourage healing and/or bone growth around and to the device <NUM>.

Now turning to <FIG>, additional information regarding the operation of intervertebral device <NUM> will be described. <FIG> depicts the device <NUM> in cross-section, and in a collapsed configuration, while <FIG> depicts the device <NUM> in cross-section, and in an expanded configuration. As shown, intervertebral device <NUM> includes an alternative element 310A within which a distal portion of the second element translates. Element 310A is vertically slidable with respect to the first element <NUM> and the third element <NUM>. As with the drive mechanism <NUM>, drive member <NUM> includes a helical thread 394T that interfaces with corresponding helical thread 340T of the second element <NUM>. Rotation of the drive member in a first direction results in distal movement of the second element <NUM> with respect to the element 310A. Rotation of the drive member in a second opposing direction results in a proximal movement of the second element <NUM> with respect to the element 310A. The second element <NUM> includes multiples protrusions 344B1-344B3, as well as multiple depressions 346B1-346B3, which interface or couple with corresponding depressions and protrusions of the third element <NUM> in a similar fashion as describes above with respect to intervertebral devices <NUM> and <NUM>. The second element <NUM> includes additional multiple protrusions 344D and depressions 346D on the opposing surface of side member 340B, which interface or couple with corresponding protrusions 324B1-B3 and depressions 326B1-B2, respectively. As with other intervertebral devices described or discussed herein, the protrusions and depressions of the elements <NUM>, <NUM>, <NUM> cooperate such that as the second element <NUM> translates distally, various surfaces of the protrusions and depressions interface or couple such that the first element <NUM> moves at least vertically away from the second element <NUM>, and the third element <NUM> moves at least vertically away in an opposing direction. With the intervertebral device <NUM> in an expanded configuration the void <NUM> is maximized allowing for therapeutic agents to be deployed therein, the therapeutic agents exiting various openings, such as openings <NUM>, <NUM>, to encourage bone growth around or adjacent to the device <NUM>. As the second element <NUM> translates in a proximal direction, the protrusions and depressions of the elements <NUM>, <NUM>, <NUM> cooperate to take on a more collapsed configuration.

Turning now to <FIG>, a delivery system <NUM> may be used to position intervertebral devices <NUM>, <NUM>, <NUM>, or any other intervertebral devices discussed or contemplated herein, between two adjacent vertebrae, and adjust the height of the corresponding device <NUM>, <NUM>, <NUM> as desired. While the delivery system <NUM> is depicted and discussed with respect to an intervertebral device 100A depicted in <FIG>, such discussion and corresponding operation applies to any intervertebral devices any other intervertebral devices discussed or contemplated herein. The delivery system <NUM> includes a handle <NUM>, operational controls <NUM> and an elongated portion <NUM> ending in a distal portion <NUM>. The distal portion <NUM> of the delivery system <NUM> is configured to engage and position an intervertebral device, such as device 100A, within a patient's body. A first operational control 404A is coupled to a first elongate member 410A (not shown) extending within the elongate portion <NUM>, from the control 404A to the distal end <NUM>, a distal end of the elongate member 410A configured to couple the delivery system <NUM> to the intervertebral device 100A. A second operation control 404B is coupled to a second elongate member 410B (not shown) extending within the elongate portion <NUM>, from the control 404B to the distal end <NUM>, the distal end of the elongate member 410B configured to operate the intervertebral device 100A, e.g. adjust a height of the device 100A.

Turning to <FIG>, the elongate member 410A ends in a threaded portion 410AT at the distal portion <NUM>, and elongate member 410B ends in distal portion <NUM> including a distal driver 412D. The elongate member 410A is rotatably slidable to elongate member 410B. The distal portion <NUM> may also include one or more mating structures <NUM> for engaging similar mating structures as part of the intervertebral device 110A, one or more mating structures <NUM> as shown in <FIG> for example. The mating structures <NUM>, <NUM> enable the delivery system <NUM> to maintain a desired orientation with respect to the device 110A. The distal end <NUM> may also include further engaging structures, such as threaded portion 410AT of the elongate member 410A, to maintain a hold on the device 110A during positioning thereof. The distal driver 412D of the distal portion <NUM> may be configured to enter a void within the intervertebral device 100A and couple with a drive member, e.g. drive member <NUM> of drive mechanism 190A.

Turning to <FIG>, operation of the first control 404A may act to rotate the threaded portion 410AT of the elongate member 410A, the threaded portion 410AT interfacing to the threaded portion 130T of the first element 110A of the intervertebral device 100A to fixedly attach the device 100A to the delivery system <NUM>. Once the device 100A is positioned within a body, between adjacent vertebrae for example, the second control 404B may be operated to rotate the driver 412D of the device <NUM>, rotation of the driver 412D acting to rotate drive member 194A resulting in adjustment of the overall height, H, of the intervertebral device 100A, as described above with respect to intervertebral device <NUM>. Turning also to <FIG> depicts the intervertebral device 100A in an expanded configuration, the second element <NUM> moving to a distal end of the first element 110A.

Turning now to <FIG>, an alternative delivery system 400A is similar to the delivery system <NUM> of <FIG>, however includes a third control 404C that operates a deflectable distal portion 408A. Turning to <FIG>, control 404C is coupled to the elongate member 406A through threaded portion 404CT that interfaces with threaded portion 406AT. Control 404C is further coupled to a proximal end of an elongate member 410C. Elongate member <NUM> is coupled to distal portion 408A through a hinge <NUM>. A distal end of the elongate member 410C is coupled to distal portion 408A of delivery system 400A through a hinge <NUM>. Distal portion 408A is also coupled to a central lumen of an elongate member 410A through gear <NUM>. Accordingly, rotation of the control 404C is converted into axial movement of elongate member 410C, which deflects the distal portion 408A with respect to elongate member 406A, as depicted in <FIG>. Elongate member 410A may include a stop <NUM> to prevent or limit axial movement of the elongate member 410C, which ultimately limits the deflection of the distal end 408A.

<FIG> depicts the distal portion 408A deflected and placement of elongate member 410B, which ends in distal portion <NUM> and driver 412D. As shown, the distal portion 408A includes one or more protrusions 420A which are configured to engage corresponding recesses on the intervertebral device, such as device <NUM> for example. The elongate member 410B may include a flexible portion positioned adjacent to the gear <NUM> such that the member 410B bends with the deflection of the distal portion 408A. <FIG> depicts the delivery system 400A interfaced to an exemplary intervertebral device, such as intervertebral device <NUM>. The elongate member 410B has been removed for illustration purposes only. In operation, the driver 412D of the distal end <NUM> of the elongate member 410B would interface with a drive member of the intervertebral device, the delivery system 400A adjusting a height of the intervertebral device, as described above.

Turning to <FIG> and <FIG>, a perspective view of an exemplary intervertebral device <NUM> includes a first element <NUM>, a second element <NUM>, and a third element <NUM>. As will be better understood in the discussion below, the elements <NUM>, <NUM>, <NUM> cooperate such that the intervertebral device <NUM> geometric height may have a minimum, collapsed configuration, as generally depicted in <FIG>, and a maximum, expanded configuration, as generally depicted in <FIG> and discussed in greater detail below.

The first element <NUM>, which may also referred to as base <NUM> or base element <NUM>, is configured to provide a base or outer structure for the intervertebral device <NUM>, and includes a first end <NUM>, a second end <NUM>, and two side portions, a first side portion <NUM> and an opposing side portion <NUM>. A bottom portion <NUM> includes one or more openings <NUM> allowing for therapeutic agents or materials, including bone growth enhancing materials, to pass therethrough. It should be readily understood that the second and third elements <NUM>, <NUM> may also include similar openings. A proximal end, e.g. end <NUM>, may include an opening <NUM> for passing a portion of one or more tools utilized for delivery of said therapeutic agents, or expanding, contracting, or locking the intervertebral device <NUM> in a specific configuration, as is discussed in greater detail below with reference to Figs.

The intervertebral device <NUM> may be expanded or contracted to any suitable height, H, between a first collapsed height H<NUM>-<NUM> and a second expanded height H<NUM>-<NUM>, with reference to <FIG> and <FIG>, respectively. For example, the intervertebral device <NUM> may be expanded from a first position, having the height of H<NUM>-<NUM> in <FIG>, to a second position, having the height of H<NUM>-<NUM> in <FIG>, or any height therebetween, and locked in any position. As stated above, the term "lock", "locked" or "locking used in conjunction with the intervertebral device <NUM>, or other intervertebral devices described or contemplated herein, shall mean to substantially maintain the position of each of the elements <NUM>, <NUM>, <NUM> with respect to each other. The end <NUM> may also include structures, such as threaded structure 530T, which may allow for attachment points to a delivery system, as described above with respect to intervertebral device <NUM>, for example. Such attachment points may also form the basis for at least initially positioning the intervertebral device <NUM>, for example positioning the device <NUM> between two adjacent vertebrae. The elements <NUM>, <NUM>, <NUM> are configured to create a void <NUM> within the intervertebral device <NUM>, the void <NUM> increasing during expansion of the intervertebral device <NUM> from a collapsed configuration to an expanded configuration, for example. In other delivery system embodiments, the delivery system may include tubular members through which therapeutic agents may be introduced, for example, to internal spaces or voids within the intervertebral device <NUM> and exiting through the one or more openings <NUM> of the element <NUM>, or similar openings of the remaining elements <NUM>, <NUM>. In this way, such therapeutic agents may contact surrounding tissues, such as bone tissue of the vertebra.

The third element <NUM> is slidably interfaced to the first element <NUM> such that the third element <NUM> at least slides vertically with respect to the first element <NUM>. The third element <NUM> may include one or more openings <NUM> in a top portion or top surface <NUM> thereof to allow for passage or introduction of therapeutic agents therethrough. The top portion <NUM> may include one or more protrusions <NUM> that may aide in holding the top portion <NUM> immobile with respect to adjacent structures or biological tissue, such as vertebrae structures for example. While only a few protrusions <NUM> are identified, additional or less protrusions <NUM> may be utilized. Additionally such protrusions, like protrusions <NUM>, may be constructed from any biocompatible material and in any suitable form, and may be used with other elements or surfaces of intervertebral device <NUM>, or any other intervertebral device described or contemplated herein. For example, sidewalls <NUM>, <NUM> of element <NUM> may include one or more protrusions (not shown), similar to protrusions <NUM>, and a bottom portion <NUM> of base <NUM> may include one or more protrusions, similar to protrusions <NUM>.

Turning specifically to <FIG>, the element <NUM> may include a positioning structure or protrusion <NUM> which may be configured or adapted to move within a corresponding channel <NUM> provided in element <NUM> to ensure that the element <NUM> moves in a specific direction with respect to the element <NUM>. Accordingly, channel <NUM> and associated structure <NUM> may be configured to form any desirable angle with respect to a longitudinal axis of element <NUM>. As depicted, channel <NUM> is substantially perpendicular to a longitudinal axis of element <NUM> and, therefore, the element <NUM> moves in a direction substantially perpendicular to the longitudinal axis of element <NUM>.

Turning to <FIG>, the intervertebral device <NUM> is depicted in an expanded configuration and the viewpoint is from the first end <NUM>. The elements <NUM>, <NUM>, <NUM> are configured such that when in an expanded configuration the open space or void <NUM> is defined, e.g., as seen through opening <NUM> or opening <NUM>. In this way, once the device <NUM> is deployed therapeutic agents may be positioned within the void <NUM> from the first end <NUM> to the second end <NUM> and into voids of the other elements <NUM>, <NUM>. Such material may further flow out of the open space via additional openings, such as openings <NUM> and <NUM>, positioned about the elements <NUM>, <NUM>, <NUM>.

Turning to <FIG>, an elevation view depicting the elements <NUM>, <NUM>, <NUM> in cross-section is shown. The third element <NUM> may include a plurality of sloped surfaces <NUM> that are configured or adapted to contact a respective one of a plurality of sloped surfaces <NUM> of second element <NUM>. Accordingly, as the second element or sliding element <NUM> translates between the first end <NUM> and the second end <NUM> of the element <NUM>, the sloped surfaces <NUM> contact and slide along corresponding respective sloped surfaces <NUM> of the third element <NUM> resulting in movement of the element <NUM> in a direction defined by channel <NUM>, and the sloped surfaces <NUM>, <NUM>. As depicted, translation of sliding element <NUM> from the first end <NUM> toward the second end <NUM> results in movement of the element <NUM> in a vertical direction away from the base element <NUM>. Translation of the sliding element <NUM> from the second end <NUM> toward the first end <NUM> results in movement of the element <NUM> in a vertical direction toward the base element <NUM>.

The first element <NUM> or base element <NUM> includes a plurality of engaging elements <NUM> that protrude from a top inner surface of the bottom portion <NUM> of element <NUM>. Second element <NUM> includes a plurality of engaging elements <NUM>, at least one engaging a respective one of the plurality of engaging elements <NUM>. While depicted as being integral to the respective elements <NUM>, <NUM>, the engaging elements <NUM>, <NUM> may be individual parts attached or affixed to the surfaces of the base element <NUM> and sliding element <NUM>, respectively. The engaging elements <NUM>, <NUM> are depicted as having similar shapes, e.g., triangular portions, however in other configurations, the shapes can be dissimilar. For example, each of the engaging elements <NUM> may include a concave surface while each of the engaging elements <NUM> may include a corresponding mating convex surface. The shapes of the engaging elements <NUM>, <NUM> may also be non-mating surfaces such that gaps exist at the interface between the engaging elements <NUM>, <NUM>, for example. Also, while depicted as triangular structures, each of the elements <NUM>, <NUM> may be nonsymmetrical along its vertical central axis, passing through the tip of each element <NUM>, <NUM>.

The intervertebral device <NUM> is configured such that applying a lateral force to the sliding element <NUM> to translate the element <NUM> between the first and second ends <NUM>, <NUM> of base member <NUM>, results in each engaging element <NUM> sliding up and over a corresponding engaging element <NUM>, and engaging an adjacent engaging element <NUM> in the direction of the movement of sliding element <NUM>. Accordingly, sliding element <NUM>, while primarily moving along the longitudinal axis of the base element <NUM>, also move vertically in accordance with the geometry outline and coupling of the engaging elements <NUM>, <NUM> of the sliding element <NUM> and base element <NUM>, respectively.

Turning back to <FIG> and <FIG>, a plurality of pins <NUM> are coupled to sliding member <NUM> and extend through corresponding openings <NUM> in the side portions <NUM>, <NUM> of base element <NUM>. With the intervertebral device <NUM> in the collapsed configuration, as depicted in <FIG>, the sliding element <NUM> is nearer the first end <NUM>, the pins <NUM> being nearer the first end <NUM>, as well. With the intervertebral device <NUM> in the expanded configuration, as depicted in <FIG>, the sliding element <NUM> is nearer the second end <NUM>, the pins <NUM> being nearer the second end <NUM> as well. The openings <NUM> of the first element <NUM> are spaced to allow some vertical travel of the sliding element <NUM> and pins <NUM> in accordance with the geometrical shapes, e.g. height, of the engaging elements <NUM>, <NUM>. It is noted that by adjusting the slope of each side surface of the engaging elements <NUM>, <NUM> the translational force to move the sliding element <NUM> in the presence of a compression force between the top portion <NUM> of element <NUM> and the bottom portion <NUM> of the base element <NUM> may differ in accordance with the corresponding element <NUM>, <NUM> sloped surfaces. The slopes of each side surface of the engaging elements <NUM>, <NUM>, which may be continuous or may not be continuous, may be configured to encourage movement of the sliding element <NUM> in a first direction along the longitudinal axis of the base <NUM> and discourage movement of the sliding element <NUM> in a second opposite direction. In any case, the engaging elements <NUM>, <NUM> are configured, e.g., with suitable sloped surfaces or the like, to become locked or immovable when a compression force exists between the third element <NUM> and the base element <NUM>.

Turning now to <FIG>, the intervertebral device <NUM> is depicted in an expanded configuration. With a lateral force applied to sliding element <NUM> moving the element <NUM> toward end <NUM>, in a ratcheting manner, for example, the engaging elements <NUM>, <NUM> continuously engage and disengage with adjacent opposing engaging elements <NUM>, <NUM>. As the element <NUM> translates, the third element <NUM> moves vertically to increase the overall height of the device <NUM>. With a compression force applied between the third element <NUM> and the base element <NUM>, e.g. when the device <NUM> is positioned between adjacent tissue surfaces, such as two adjacent vertebrae, the engaging elements <NUM>, <NUM> of the sliding element <NUM> and base element <NUM>, respectively, engage and prevent the sliding element <NUM> to translate further.

Turning to Figs. 30A-30C, an exemplary tool <NUM> utilized to translate sliding element <NUM>, or similar sliding elements discussed or described herein, includes a distal end <NUM> having a protrusion <NUM> adjacent to a groove <NUM>. The protrusion is adapted to fit a groove <NUM> at a proximal end of the sliding element <NUM>. As depicted in Fig. 30A, the tool <NUM> is angled or rotated along its axis such that the protrusion <NUM> freely enters the proximal end of the sliding element <NUM>, as depicted in Fig. 30B. Once inserted, the tool <NUM> may be rotated in a direction indicated by arrow 30A such that the protrusion <NUM> is positioned within the groove <NUM> of the proximal end of the sliding element <NUM> and held in place through the cooperation of the protrusion <NUM> and a protrusion <NUM> at the proximal end of sliding element <NUM>, as depicted in Fig. 30C.

The groove <NUM> of the sliding element <NUM> cooperates with the protrusion <NUM> of the tool <NUM> to rigidly attach the tool <NUM> to the element <NUM>. Once the tool <NUM> is rigidly attached to the sliding element <NUM> a user can translate the sliding element <NUM> through corresponding translation of the tool <NUM>. As described above, translation of the tool <NUM>, which results in the translation of the sliding element <NUM>, further results in the sliding element <NUM> to move between the ends <NUM>, <NUM> of the base member <NUM>. As the sliding element <NUM> translates or moves between the ends <NUM>, <NUM>, the element <NUM> moves in a vertical direction with respect to the base element <NUM> to change the overall height, H, of the intervertebral device <NUM>. As should be readily understood, the tool <NUM> may extend from a point within a body structure to a point outside of the body.

Turning now to <FIG>, another exemplary intervertebral device <NUM> includes a first or base element <NUM>, a second or sliding element <NUM>, and a third element <NUM>. The intervertebral device <NUM> is similar to the intervertebral device <NUM>, but the elements <NUM>, <NUM>, <NUM> of the device <NUM> include different geometric structures as compared to intervertebral device <NUM>. The intervertebral device <NUM> includes a distal end <NUM> and a proximal end <NUM>, the distal end <NUM> including a different geometric structure used for positioning and operating the device <NUM>.

Turning to <FIG> and <FIG>, a perspective view of the exemplary intervertebral device <NUM> is depicted in cut view along section B-B of <FIG>. As with other intervertebral devices described or contemplated herein and better understood in light of the discussion below, the elements <NUM>, <NUM>, <NUM> cooperate such that the intervertebral device <NUM> geometric height, H<NUM>, may have a minimum, collapsed configuration, as generally depicted in <FIG>, and a maximum, expanded configuration, as generally depicted in <FIG> and discussed in greater detail below.

The first element <NUM>, also referred to as base <NUM> or base element <NUM>, is configured to provide a base or outer structure for the intervertebral device <NUM>, and includes first end <NUM>, second end <NUM>, and two side portions, a first side portion <NUM> and an opposing side portion <NUM>. A bottom portion <NUM> includes one or more openings <NUM> allowing for therapeutic agent to pass therethrough. It should be readily understood that the second and third elements <NUM>, <NUM> may also include similar openings. The proximal end <NUM>, may include an opening <NUM> for passing a portion of one or more tools utilized for delivery of said therapeutic materials, or expanding, contracting, or locking the intervertebral device <NUM> in a specific configuration.

The intervertebral device <NUM> may be expanded or contracted to any suitable height, H<NUM>, between a first collapsed height H<NUM>-<NUM> and a second expanded height H<NUM>-<NUM>, with reference to <FIG> and <FIG>, respectively. For example, the intervertebral device <NUM> may be expanded from a first position, having the height of H<NUM>-<NUM> in <FIG>, to a second position, having the height of H<NUM>-<NUM> in <FIG>, or another position therebetween, and locked in the position. The proximal end <NUM> may also include structures, such as protrusions 730P and grooves <NUM>, which may allow for attachment points to a delivery system (not shown), as described below with respect to delivery device <NUM> of <FIG>. Such attachment points may also form the basis for at least initially positioning the intervertebral device <NUM>, for example between two adjacent vertebrae. As described in greater detail below, the delivery system <NUM> may include tubular members through which therapeutic agents may be introduced, for example, to internal spaces within the intervertebral device <NUM> and exiting through the one or more openings <NUM> of the element <NUM>, or similar openings of the remaining elements <NUM>, <NUM>. In this way, such agents or materials may contact surrounding tissues, such as bone tissue.

The third element <NUM> is slidably interfaced to the first element <NUM> such that the third element <NUM> at least slides vertically with respect to the first element <NUM>. The third element <NUM> may include one or more openings <NUM> in a top portion <NUM> thereof to allow for passage or introduction of therapeutic elements or bone growth enhancing materials therethrough. The top portion <NUM> may include one or more protrusions <NUM> that may aide in holding the top portion <NUM> immobile with respect to adjacent structures or biological tissue, such as vertebrae structures for example. While only a few protrusions <NUM> are identified, additional or less protrusions <NUM> may be utilized. Such protrusion structures <NUM> may be constructed from any biocompatible material and in any suitable form and may be applied to any embodiment described or contemplated herein. Additionally, sidewalls <NUM> of element <NUM> may include one or more protrusions (not shown), and a bottom portion <NUM> of base <NUM> may include one or more protrusions <NUM>. Protrusions <NUM> may, for example, may be similar to protrusions <NUM>, which may aide in holding a bottom portion <NUM> immobile with respect to adjacent structures or biological tissue, such as vertebrae structures for example.

Turning specifically to <FIG>, the element <NUM> may include a positioning structure or protrusion similar to the protrusion <NUM> of the base element <NUM> of device <NUM>, which may be configured or adapted to move within a corresponding channel similar to the channel <NUM> provided in element <NUM> of device <NUM>, to ensure that the element <NUM> moves in a specific direction with respect to the element <NUM>. Accordingly, as with the device <NUM>, the channel and associated structure may be configured to form any desirable angle with respect to a longitudinal axis of element <NUM>. The channel of element <NUM> is substantially perpendicular to a longitudinal axis of element <NUM> and, therefore, the element <NUM> moves in a direction substantially perpendicular to the longitudinal axis of element <NUM>.

As with the intervertebral device <NUM>, a void or space <NUM> is defined by the first, second, and third element <NUM>, <NUM>, <NUM> of the intervertebral device <NUM>, the void increasing as the device <NUM> transitions from a collapsed configuration to an expanded configuration. In this way, once the device <NUM> is deployed therapeutic agents may be positioned within the void <NUM> from the first end <NUM> to the second end <NUM>. Such agents may further flow out of the open space via additional openings, such as openings <NUM> and <NUM>, positioned about the elements <NUM>, <NUM>, <NUM>.

Turning back to both <FIG> and <FIG>, the third element <NUM> may include a plurality of sloped surfaces <NUM> that are configured or adapted to contact a respective one of a plurality of sloped surfaces <NUM> of second element <NUM>. Accordingly, as the second element or sliding element <NUM> translates between the first end <NUM> and the second end <NUM> of the element <NUM>, the sloped surfaces <NUM> contact and slide along corresponding respective sloped surfaces <NUM> of the third element <NUM> resulting in movement of the element <NUM> in a vertical direction, e.g. defined by a channels and wall structures between the first element <NUM> and the third element <NUM>. As depicted, translation of sliding element <NUM> from the first end <NUM> toward the second end <NUM> results in movement of the element <NUM> in a vertical direction away from the base element <NUM>. Translation of the sliding element <NUM> in a direction from the second end <NUM> toward the first end <NUM> results in movement of the element <NUM> in a vertical direction toward the base element <NUM>.

The first element or base element <NUM> includes a plurality of engaging elements <NUM> that protrude from a top inner surface of the bottom portion <NUM> of element <NUM>. Second element <NUM> includes a plurality of engaging elements <NUM>, at least one of the elements <NUM> engaging a respective one of the plurality of engaging elements <NUM>. While depicted as being integral to the respective elements <NUM>, <NUM>, the engaging elements <NUM>, <NUM> may be individual parts attached or affixed to the surfaces of the base element <NUM> and sliding element <NUM>, respectively. As with the engaging elements <NUM>, <NUM> of the intervertebral device <NUM>, the engaging elements <NUM>, <NUM> are depicted as having similar shapes, e.g., triangular portions, however in other configurations, the shapes can be dissimilar, or may be nonsymmetrical along its vertical central axis, passing through the tip of each element <NUM>, <NUM>.

As with intervertebral device <NUM>, the intervertebral device <NUM> is configured such that applying a lateral force to the sliding element <NUM> to translate the element <NUM> between the first and second ends <NUM>, <NUM> of base member <NUM>, results in each engaging element <NUM> sliding up and over a corresponding engaging element <NUM>, and engaging an adjacent engaging element <NUM> in the direction of the movement of sliding element <NUM>. Accordingly, sliding element <NUM>, while primarily moving along the longitudinal axis of the base element <NUM>, also moves vertically in accordance with the geometry outline and coupling of the engaging elements <NUM>, <NUM> of the sliding element <NUM> and base element <NUM>, respectively.

The intervertebral device <NUM> further includes a plurality of pins <NUM> coupled to sliding member <NUM> and extending through corresponding openings <NUM> in the side portions <NUM>, <NUM> of base element <NUM>. With the intervertebral device <NUM> in the collapsed configuration, as depicted in <FIG>, the sliding element <NUM> is nearer the first end <NUM>, the pins <NUM> being nearer the first end <NUM>, as well. With the intervertebral device <NUM> in the expanded configuration, as depicted in <FIG>, the sliding element <NUM> is nearer the distal end or second end <NUM>, the pins <NUM> being nearer the second end <NUM> as well. The openings <NUM> of the first element <NUM> are spaced to allow some vertical travel of the sliding element <NUM> and pins <NUM> in accordance with the geometrical shapes, e.g. height, of the engaging elements <NUM>, <NUM>. It is noted that by adjusting the slope of each side surface of the engaging elements <NUM>, <NUM> the translational force to move the sliding element <NUM> in the presence of a compression force between the top portion <NUM> of element <NUM> and the bottom portion <NUM> of the base element <NUM> may differ in accordance with the corresponding element <NUM>, <NUM> sloped surfaces. The slopes of each side surface of the engaging elements <NUM>, <NUM>, which may be linear or may be nonlinear, may be configured to encourage movement of the sliding element <NUM> in a first direction along the longitudinal axis of the base <NUM> with respect to the sliding element <NUM> in a second opposite direction. In any case, the engaging elements <NUM>, <NUM> are configured, e.g., with suitable sloped surfaces or the like, to become locked or immovable when a compression force exists between the third element <NUM> and the base element <NUM>.

Turning specifically to <FIG>, the sliding element <NUM> may include a protrusion <NUM> configured or adapted to slidably interface with a corresponding recessed portion or groove 736A along the inner wall of the third element <NUM>. The protrusion <NUM> cooperates with recessed portion 736A such that when the sliding element <NUM> translates in a proximal direction, in a direction toward proximal end <NUM> of the intervertebral device for example, the surfaces of the protrusion <NUM> engage surfaces of the recessed portion 736A to encourage the third element <NUM> to move vertically toward the first element <NUM>.

As with vertebral device <NUM>, in the presence of a lateral force applied to sliding element <NUM> moving the element <NUM> toward end <NUM>, in a ratcheting manner, for example, the engaging elements <NUM>, <NUM> continuously engage and disengage with adjacent opposing engaging elements <NUM>, <NUM>. As the element <NUM> translates, the third element <NUM> moves vertically to increase the overall height, H<NUM>, of the device <NUM>. With a compression force applied between the third element <NUM> and the base element <NUM>, e.g. when the device <NUM> is positioned between adjacent tissue surfaces, such as two adjacent vertebrae, the engaging elements <NUM>, <NUM> of the sliding element <NUM> and base element <NUM>, respectively, engage and prevent the sliding element <NUM> from further translating. For illustration purposes only, the sliding element <NUM> of the intervertebral device <NUM> may be translated through the use of a tool, such as exemplary tool <NUM> described above with respect to intervertebral device <NUM>, the distal portion of the sliding element <NUM> including protrusions and grooves to interface with the tool <NUM>, for example.

Turning to <FIG>, the intervertebral device <NUM> is depicted in cross-section along section A-A of <FIG>. The intervertebral device <NUM> is depicted in a collapsed configuration in <FIG> and an expanded configuration in <FIG>. In particular, the sliding element <NUM> includes a device <NUM> to aid in maintaining contact between the engaging elements <NUM>, <NUM> of the sliding element <NUM> and base element <NUM>, respectively. The retention device <NUM> includes the pin 745A and spring <NUM>, the spring <NUM> seated in bore <NUM>. As depicted, the pin 745A may extend from a first opening <NUM> in side portion <NUM> to a second opening <NUM> in side portion <NUM> (not shown), similar to openings <NUM> of the intervertebral device of <FIG>. The pin 745A includes a protrusion <NUM> that extends from a central longitudinal axis of the pin 745A toward the bottom <NUM> of the first element <NUM>. In operation, as the sliding element <NUM> translates between the two ends <NUM>, <NUM>, the engaging elements <NUM>, <NUM> repeatedly engage and disengage resulting in the sliding element <NUM> repeatedly moving vertically away from and toward to the bottom portion <NUM> of the base element <NUM>, as described above with respect to the intervertebral device <NUM>. As the sliding element <NUM> moves away from the base element <NUM> the ends of the pin 745A engage the top surfaces of the corresponding openings <NUM> in respective side portions <NUM>, <NUM>, acting to compress the spring <NUM>. As the engaging elements <NUM> of the sliding element <NUM> pass over the corresponding engaging elements <NUM> of the base element <NUM> the spring imparts a force upon the sliding element <NUM> to encourage re-engagement of the adjacent engaging elements <NUM>, <NUM>. In this way, the engaging elements <NUM> are biased to remain coupled to corresponding engaging elements <NUM> during each movement of the sliding element <NUM>, particularly in a no-load situation, where the force between the third element <NUM> and the first element <NUM> is minimal for examples. Accordingly, when a compression force is applied between the top surface <NUM> of the third element <NUM> and the bottom surface <NUM> of the base element <NUM>, engaging elements <NUM>, <NUM> maintain the current position of all three element <NUM>, <NUM>, <NUM> and, ultimately, the current height, H<NUM>, of the intervertebral device <NUM>.

Turning to <FIG>, a delivery system <NUM> for positioning and operating intervertebral device <NUM>, or other intervertebral devices described or contemplated herein, includes an attachment assembly <NUM> and an expansion tool <NUM>. The attachment assembly <NUM> is utilized for attaching the intervertebral device, such as intervertebral device <NUM>, to the delivery system <NUM>. The expansion tool <NUM> is utilized for setting a height of the intervertebral device <NUM> once the device <NUM> has been deployed, between adjacent vertebrae for example. Turning to <FIG>, the attachment assembly <NUM> includes an interface unit <NUM>, a control assembly <NUM>, a grasper unit <NUM>, and an elongate member <NUM> that extends from the control assembly <NUM> to the grasper unit <NUM>. The interface unit <NUM> is configured to attach the attachment assembly <NUM> to the expansion tool <NUM>, as is discussed in greater detail below. The elongate member <NUM> may include one or more lumens or members therein for controlling the grasper unit <NUM> or the intervertebral device <NUM>.

Turning to <FIG>, operation of the grasper unit <NUM> will be described in greater detail. The grasper unit <NUM> includes a housing <NUM> having first and second slots <NUM>S1, <NUM>S2, a control ring <NUM> operational coupled to first and second arms 846A, 846B. The elongate member <NUM> is fixedly coupled to the housing <NUM> via pins <NUM>. An elongate member <NUM> passes through a lumen of the elongate member <NUM>, and includes a threaded portion 816T that is rotationally coupled to threaded portion 844T of the control ring <NUM>. Rotational movement of the elongate member <NUM> is transformed into axial movement of the control ring <NUM> through treaded portions 816T, 844T. First arm 846A includes first and second protrusions 846AP1, 846AP2 positioned within slots 842AS1, 842AS2, respectively, and a third protrusion 846AP3 at a distal tip of the arm 846A. Similarly, second arm 846B includes first and second protrusions 846BP1, 846BP2 positioned within slots 842BS1, 842BS2, respectively, and a third protrusion 846BP3 at a distal tip of the arm 846B. As depicted in <FIG>, arm 846A includes a raised portion 848A configured to engage a surface of housing <NUM>. More specifically, the raised portion 848A includes a surface 848AS configured to engage a surface 843As of the housing. In similar fashion, arm 846B includes a raised portion 848B having a surface 848As configured to engage a surface 843AS of the housing <NUM>. Accordingly, as the housing <NUM> moves distally relative to the arms 846A, 846B, a distance between the protrusions 846AP3, 846BP3 increases.

<FIG> depict the arms 846A, 846B in an open configuration, while <FIG> depict the arms 846A, 846B in a closed configuration, the arms 846A, 846B being closer to each other in the open configuration than in the closed configuration. In operation, rotation of the elongate member <NUM> in a first direction results in axial movement of the control ring <NUM> as indicated by arrow 816A. Since the control ring <NUM> is coupled to the arms 846A, 846B, the arms move in the same direction as the control ring, and the surfaces 848AS, 848BS cooperate with surfaces 843AS, 843BS of housing <NUM> to move the arms apart from each other, e.g., transitioning to a closed configuration for example. Continued axial movement of the control ring results in moving the arms 846A, 846B axially to clamp onto the proximal features 730PA and 730PB. Rotation of the elongate member <NUM> in a second direction opposite to the first direction, results in axial movement of the control ring <NUM> in a direction opposite to that indicated by arrow 816A. As the control ring <NUM> moves distally with respect to housing <NUM>, as well as arms 846A, 846B, distal surfaces of protrusions 846AP3, 846BP2 engage or cooperate with distal portions of slots <NUM>S2 to deflect the arms inward. Accordingly, the more the arms 846A, 846B move distally with respect to the housing <NUM>, the more the distal protrusions 846AP3, 846BP3 move distally and toward to each other, disengaging from the attachment point, and being free from the profile of the protrusions 730PA and 730PB, of the intervertebral device <NUM>.

Turning to <FIG>, the interaction between the control ring <NUM>, arms 846A, 846B, and the elongate member <NUM> is depicted. The control ring <NUM> includes first and second "T" slots <NUM>, each coupled to a proximal end of one of the arms 846A, 846B, as depicted in <FIG>. The coupling point between the slots <NUM> and the arms 846A, 846B allows for the distal protrusions 846AP3, 846BP3 to move toward and away from each other to enable a position for coupling between the arms 846A, 846B and the intervertebral device <NUM>. <FIG> depicts the control ring <NUM> rotatably coupled to the elongate tube <NUM>.

Turning to <FIG>, the interface unit <NUM> is fixedly attached to the control assembly <NUM>, the control assembly <NUM> fixedly attached to elongate member <NUM>. The control assembly <NUM> includes a rotatable control <NUM>, a clutch assembly <NUM>, and a spring <NUM>. The rotatable control <NUM> is rotationally attached to a clutch member 826A, as part of a clutch assembly <NUM>. A clutch member 826B is rotationally attached to elongate member <NUM>. The spring <NUM> provides a force to encourage coupling between clutch member 826A and clutch member 826B at fingers 826F. The fingers are configured such that rotation of the rotatable control <NUM> in a first direction results in constant engagement of the fingers, and rotation of the rotatable control <NUM> in a second direction opposite to the first direction results in the fingers of clutch member 826A slipping past the fingers of clutch member 826B once the rotational torque becomes greater than the force applied by the spring <NUM> on the clutch member 826A. In this way, rotation of the rotatable control <NUM> in the second direction results in the arms 846A, 846B couplings to the attachment point of the intervertebral device <NUM>, without over-tightening the connection which may result in undue stress in the delivery system <NUM> or the intervertebral device <NUM>, or both.

Turning to <FIG>, the expansion tool <NUM> includes a handle or handle portion <NUM> and an elongate shaft rotatably coupled to the handle <NUM>. The expansion tool <NUM> is utilized for moving the second element, for example the second element <NUM> of the intervertebral device <NUM>, along a longitudinal axis of the first element <NUM> to set a height of the intervertebral device <NUM> once the device <NUM> has been deployed, between adjacent vertebrae for example.

Turning to <FIG>, handle portion <NUM> includes an interface assembly <NUM> and an attachment control <NUM>. The interface assembly <NUM> is configured to attach or interface the handle portion <NUM> with the attachment assembly <NUM>. More specifically, the interface assembly <NUM> interfaces with the interface element <NUM> of the attachment assembly <NUM>. The interface assembly <NUM> includes a pushbutton <NUM> in a slotted portion <NUM> of the handle <NUM>. The pushbutton <NUM> is biased by a spring <NUM>, which is positioned within a bore <NUM> of the handle <NUM>. With specific reference to <FIG>, when the pushbutton <NUM> is depressed, compressing the spring <NUM>, the interface element <NUM> of the attachment assembly <NUM> may be positioned within an opening <NUM> within the handle <NUM>. The interface element <NUM> includes a notch 812N sized to be equal to or greater than a width of the pushbutton <NUM>, such that once the interface element <NUM> is positioned within the opening <NUM> the pushbutton <NUM> may be released and a portion 872A of the pushbutton <NUM> is positioned within the notch 812N, as depicted in <FIG>.

Attachment control <NUM> is utilized to engage the second element, for example element <NUM>, with the elongate shaft <NUM>. The control <NUM> includes a lever <NUM> rotatably coupled to the shaft <NUM>, the lever <NUM> being configured to rotate the shaft to enable engagement of the shaft <NUM> with the second element <NUM>. The control <NUM> may further include a slide lock <NUM>, which is configured to lock the lever control <NUM> such that the shaft <NUM> is maintained in a desired rotational orientation, during operation of an intervertebral device for example.

Turning to <FIG>, a distal end <NUM> of elongate shaft <NUM> includes a protrusion <NUM> adjacent to a groove <NUM>. The protrusion <NUM> may be adapted to fit a corresponding groove <NUM> at a proximal end of the sliding element <NUM>. As depicted in <FIG>, the shaft <NUM> is angled or rotated along its axis such that the protrusion <NUM> freely enters the proximal end of the sliding element <NUM>. Once inserted, the shaft <NUM> may be rotated, through operation of the attachment control <NUM> for example, such that the protrusion <NUM> is positioned within the groove <NUM> and held in place through the cooperation of the protrusion <NUM> and a protrusion 740P at the proximal end of sliding or third element <NUM>, as depicted in <FIG>.

The groove <NUM> of the sliding element <NUM> cooperates with the protrusion <NUM> of the shaft <NUM> to rigidly attach the shaft <NUM> to the element <NUM>. Once the shaft <NUM> is rigidly attached to the sliding element <NUM> a user can translate the sliding element <NUM> through corresponding translation of the shaft. Turning to <FIG>, the handle <NUM> may also include an axial control <NUM> configured to translate the shaft <NUM> in proximal and distal directions. The axial control <NUM> includes a rotational control <NUM> having threaded portion <NUM> that interfaces with corresponding threaded portion 862T of the handle <NUM>, the axial control <NUM> being coupled to the shaft <NUM>. Shaft <NUM> is axially coupled, not rotationally coupled, to the rotational control <NUM>. Accordingly, the axial control <NUM> converts rotational movement of the control <NUM> into axial movement of the shaft <NUM>. As the rotational control <NUM> is rotated in a first direction the control <NUM> moves distally within the handle portion, which acts to move shaft <NUM> distally. As the rotational control <NUM> is rotated in a second direction the control <NUM> moves proximally within the handle portion, which acts to move shaft <NUM> proximally. Translation of the shaft <NUM> results in the translation of the sliding element <NUM>, further resulting in the sliding element <NUM> moving between the ends <NUM>, <NUM> of the base member <NUM>. As the sliding element <NUM> translates or moves between the ends <NUM>, <NUM>, the element <NUM> moves in a vertical direction with respect to the base element <NUM> to change the overall height, H, of the intervertebral device <NUM>.

The intervertebral devices described herein may be made from any suitable biocompatible material, including but not limited to metals, metal alloys (e.g. stainless steel) and polymers (e.g. polycarbonate), and may be formed using any appropriate process, such as screw-machining or molding (e.g. injection molding). The intervertebral devices herein may be sized for minimally invasive procedures having operating lumens at about <NUM> or less.

Claim 1:
An intervertebral device, comprising:
a base (<NUM>) including a distal end (<NUM>) and a proximal end (<NUM>), a longitudinal axis extending from the distal end (<NUM>) to the proximal end (<NUM>), and a bottom surface (<NUM>);
a first body portion (<NUM>) slidably attached to the base (<NUM>) and configured to move in at least a first direction with respect to the base (<NUM>), the first direction being substantially parallel to the longitudinal axis of the base (<NUM>), the first body portion (<NUM>) including a first engaging element (<NUM>);
a second body portion (<NUM>) slidably attached to the base (<NUM>) and configured to move in at least a second direction with respect to the base (<NUM>); and
the base (<NUM>) including a second engaging element (<NUM>) configured to couple to the first engaging element,
wherein the base (<NUM>) is configured to prevent the first body portion (<NUM>) from further translating with respect to the base (<NUM>) both proximally of the proximal end (<NUM>) of the base (<NUM>) and distally of the distal end (<NUM>) of the base (<NUM>).