Patent Description:
Various publications, including patents, published applications, technical articles and scholarly articles are cited throughout the specification.

Orthopedic implants come in many different shapes and sizes to accommodate different sizes and needs of particular patients. Patent document <CIT> is an example of such an implant. For implantation, an incision at or near the site of implantation, or otherwise conducive for implantation, is made in the patient, with additional tissue dissected to create a pathway for guiding the implant to its ultimate location within the body. Larger and more irregularly shaped implants generally necessitate larger incisions and larger pathway dissections, causing additional trauma to the patient's body and risking unintended injury to the patient. In addition, such larger incisions and tissue dissection increases the risk of an infection, prolongs recovery time, and may cause additional discomfort in the patient during the post-surgery healing period.

It is desirable to minimize trauma to the body during the implantation procedure, yet there are practical limitations to these efforts insofar as the implant needs sufficient room for insertion and placement. More recently, expandable implants have emerged. These expandable implants benefit patients by requiring much smaller incisions and dissection pathways, thereby improving patient healing time and reducing discomfort.

A Laterally expandable interbody fusion cage is also disclosed in <CIT>. In such document there is provided an interbody fusion cage having a longitudinal central element for insertion into the interbody space between adjacent vertebrae to promote fusion. A pair of upper and lower channels is longitudinally provided on either side of the central element forming. On each side, a track in which the ends of a generally planar spring-like or shape-memory expansion arm is slideably captured. Prior to implantation the expansion arms are collapsed against the sides of the central element so as to present a small cross section. After implantation the arms are released and their ends are allowed to slide within the channels such that the arms bend and expand outward to define a space in which bone graft material may be packed and retained to promote bone growth.

Expandable implants currently in use rely upon manipulation during the surgical procedure. Often, this manipulation requires significant amounts of time for adjusting the implant until the final extended position is attained. The additional time required for this process increases cost of the procedure, as well as enhances the risk to the patient for developing an infection or other complications. Thus, there is a give and take in terms of reducing surgical manipulation in one part of the implantation procedure, but increasing surgical manipulation in another part of the implantation procedure.

Therefore, there remains a need in the art for implantation procedures that minimize surgical manipulation both in terms of the extent of incision and dissection required, and in terms of placement and positioning of the implant at the implantation site. It is believed that improvements in the design of expandable implants themselves can facilitate improvement in implantation procedures.

The invention features expandable implants, preferably for implantation in a human body. In some aspects, the expandable implants comprise a top portion and a bottom portion that are not connected to each other and are each independently operably connected to at least one movable joint that facilitates movement of at least one of the top portion and the bottom portion away from the other portion, and comprise at least one thermal memory spring operably connected to the implant. The thermal memory spring comprises a thermal memory material that is activated to expand the spring into a pre-established thermal memory shape or state when heated to a temperature that transitions the thermal memory spring from its compact shape or state to its activated or expanded shape or state. The material may be nitinol or an alloy thereof that has thermal memory properties. The transition temperature is preferably a temperature at or above about <NUM> degrees C. When the spring reaches the transition temperature, the spring expands into a pre-established thermal memory shape or state, and this expansion moves at least one of the top portion and the bottom portion of the implant away from the other portion to expand the implant.

The upper portion and/or the bottom portion of the implant may comprise undercuts, preferably on a surface of the upper portion and/or bottom portion that is internal to the implant, which undercuts house the thermal memory spring within the implant. The upper portion and/or the bottom portion of the implant may comprise one or more sockets, preferably on a surface of the upper portion and/or bottom portion that is internal to the implant, into which the ends of the thermal memory spring or an arch formed as part of the pre-established thermal memory shape embed when the thermal memory spring expands into the pre-established thermal memory shape. Embedding of the spring into such sockets locks the implant in an expanded state.

In some aspects, the expandable implants comprise a plurality of sidewalls that are not connected to each other and are each independently operably connected to at least one movable joint that facilitates movement of at least one sidewall away from an adjacent sidewall or adjacent sidewalls, and comprise at least one thermal memory spring operably connected to the implant. The thermal memory spring comprises a thermal memory material that is activated to expand the spring into a pre-established thermal memory shape or state when heated to a temperature that transitions the thermal memory spring from its compact shape or state to its activated or expanded shape or state. The material may be nitinol or an alloy thereof that has thermal memory properties. The transition temperature is preferably a temperature at or above about <NUM> degrees C. When the spring reaches the transition temperature, the spring expands into a pre-established thermal memory shape or state, and this expansion moves at least one sidewall away from the adjacent sidewall(s) to expand the implant.

One or more of the sidewalls of the implant may comprise undercuts, preferably on a surface of the sidewalls that is internal to the implant, which undercuts house the thermal memory spring within the implant. One or more of the sidewalls of the implant may comprise one or more sockets, preferably on a surface of the sidewalls that is internal to the implant, into which the ends of the thermal memory spring or an arch formed as part of the pre-established thermal memory shape embed when the thermal memory spring expands into the pre-established thermal memory shape. Embedding of the spring into such sockets locks the implant in an expanded state.

In some aspects, the expandable implants comprise a top portion and a bottom portion that are not connected to each other, and at least one of the top portion and the bottom portion are operably connected to at least one thermal memory spring. The thermal memory spring comprises a thermal memory material that is activated to expand the spring into a pre-established thermal memory shape or state when heated to a temperature that transitions the thermal memory spring from its compact shape or state to its activated or expanded shape or state. The material may be nitinol or an alloy thereof that has thermal memory properties. The transition temperature is preferably a temperature at or above about <NUM> degrees C. When the spring reaches the transition temperature, the spring expands into a pre-established thermal memory shape or state, and this expansion moves at least a section of the top portion away from at least a section of the bottom portion to expand the implant.

The upper portion and/or the bottom portion of the implant may comprise undercuts, preferably on a surface of the upper portion and/or bottom portion that is internal to the implant, which undercuts house the thermal memory spring within the implant. The upper portion and/or the bottom portion of the implant may comprise one or more sockets, preferably on a surface of the upper portion and/or bottom portion that is internal to the implant, into which the ends of the thermal memory spring or an arch formed as part of the pre-established thermal memory shape embed when the thermal memory spring expands into the pre-established thermal memory shape. Embedding of the spring into such sockets locks the implant in an expanded state. The upper portion and/or the bottom portion of the implant may each be independently operably connected to a hinge. The at least one thermal memory spring may be operably connected to at least one expansion roller that facilitates movement of at least a section of the top portion away from at least a section of the bottom portion to expand the implant. In some embodiments, the expansion roller embeds into the undercuts or sockets, thereby locking the expansion roller in place between the upper portion and the bottom portion when the thermal memory spring expands into the pre-established thermal memory shape.

In some aspects, a portion of the thermal memory spring, for example, the first end and/or the second end may expand outside of the implant, and contact a bone surface proximal to the implant surface, thereby providing for or otherwise enhancing anti-migration or anti expulsion of the implant. Portions of the expanded thermal memory spring may contact bone surfaces, and embed into the bone, thereby reducing or eliminating undesired re-positioning, movement, or expulsion of the implant. Thus, the expanded thermal memory spring may comprise anti-expulsion edges or features. Any of the thermal memory springs described or exemplified herein may comprise anti-expulsion edges or features.

In accordance with any of the implants, the thermal memory spring may comprise a pre-established thermal memory shape that includes at least one arch. The at least one arch may be located substantially in the middle of the thermal memory spring. The thermal memory spring may comprise a pre-established thermal memory shape that includes at least two arches. The thermal memory spring may comprise a pre-established thermal memory shape that includes a plurality of arches. In some aspects, a slot is present between each arch. The thermal memory spring may comprise at least one spring arm and at least one truss arm, and in some aspects may comprise a plurality of spring arms and a plurality of truss arms. When the thermal memory spring expands into the pre-established thermal memory shape or state, the at least one or plurality of truss arm(s) extend(s) outward until an end of the at least one or plurality of truss arm(s) embed(s) in a notch on an internal surface of the at least one or plurality of spring arm(s). Embedding of the truss arm end(s) into the notch locks each spring arm in a pre-established thermal memory position. The thermal memory spring may comprise a solenoid shape, including a plurality of arches, with each arch being separated from an adjacent arch by a slot. The solenoid-shaped spring may comprise one or more expansion arm, which extend from at least one of the ends of the spring.

Methods of implanting the implants in a patient are provided, which include implanting a thermal memory spring-containing implant in a patient. The implants are inserted into the patient, then placed and positioned within the desired location of implantation, and allowed to warm to the temperature at which the thermal memory spring is activated to assume its thermal memory shape and expand the implant. The practitioner may actively warm the implant to facilitate activation of the spring. The implant may be adjusted and re-positioned as necessary after the implant has expanded. Conversely, in some aspects, if the implant is found to be improperly positioned, cooling the device with a medium such as refrigerated saline solution may cause the thermally activated spring to at least partially deactivate and at least partially return to at least a partially contracted shape, making the implant more maneuverable. Due to the properties of Nitinol/Titanium alloys as well as other thermally activated materials, this reversible process can be completed numerous times. Thus, it is preferable that the spring activation and expansion be reversible, but only upon sufficient cooling such that an implant comprising such a spring would not improperly contract into a compact state when implanted within the body. An implant may comprise a bone graft material to facilitate osteointegration of the implant after implantation.

Kits comprising the implants are also provided. Kits comprise at least one implant, at least one thermal memory spring, and instructions for using the implant in a method for implanting the implant. Preferably, the implant is pre-fabricated to include the spring, although in some aspects, the practitioner may insert the spring into the implant.

The invention is best understood from the following detailed description when read in connection with the accompanying drawing. It is emphasized that, according to common practice, the various features of the drawing are not to scale. Included in the drawing are the following figures:.

Various terms relating to aspects of the present invention are used throughout the specification and claims. Such terms are to be given their ordinary meaning in the art, unless otherwise indicated. Other specifically defined terms are to be construed in a manner consistent with the definition provided herein.

As used herein, the singular forms "a," "an," and "the" include plural referents unless expressly stated otherwise.

The invention features mechanisms for expanding implants following their insertion into the body. A foundational feature is an shape-memory spring <NUM> comprised of a material that has a thermal shape memory. For example, certain metals, including Nitinol (a nickel and titanium alloy) may be shaped into a desired shape or state or configuration at very high temperatures, then forcibly straightened, relaxed, or held in a different shape or state or configuration at room temperature. When the metals are exposed to temperatures greater than room temperature, the metals re-assume the shape or state into which they were formed at the very high temperature, or assume their activated configuration or shape or state. This phenomenon is recognized in the art under various terms, including shape memory, thermal memory, thermal shape memory, and super-elastic memory, and such terms are used interchangeably herein. Accordingly, in some aspects, the invention features shape-memory springs <NUM>.

Preferably, the thermal memory shape of the shape-memory springs <NUM> described and exemplified herein is assumed at temperatures near body temperature or higher (e.g., <NUM> degrees C, <NUM> degrees C, <NUM> degrees C, <NUM> degrees C, <NUM> degrees C, or higher). For example, at room temperature or other temperature below body temperature, the shape-memory springs <NUM> are in a relaxed state (the shape into which they were forcibly established after creating the desired shape at very high temperatures), but are activated, and expand or otherwise assume their thermal memory shape at body temperature or higher.

In certain aspects, the shape-memory spring <NUM> comprises a metal with a thermal shape memory. The spring <NUM> comprises a first end <NUM>, a second end <NUM>, and a mid-section <NUM> between the first end <NUM> and second end <NUM>. In some aspects, the spring <NUM> comprises a rectangular shape, for example, as shown in <FIG>, and the spring <NUM> may lay substantially flat at room temperature (<FIG>), and may form at least one arch <NUM> (<FIG>) at elevated temperatures such as body temperature. For example, the spring <NUM> may comprise an arched thermal memory that is attained when the spring <NUM> is heated to at least body temperature. The at least one arch <NUM> occurs within the mid-section <NUM>, and the arch <NUM> may be substantially in the center of the spring <NUM> as shown in <FIG> or may be off-center, or may be more proximal to the first end <NUM> and/or the second end <NUM>.

In some aspects, the spring <NUM> may comprise two arches 416a and 416b at the activation temperature, as shown in <FIG>. In the embodiment shown in <FIG>, the spring <NUM> may comprise a narrower width relative to the embodiment shown in <FIG>. The spring <NUM> may comprise a plurality of arches <NUM>, including any suitable number of arches <NUM>. Three, four, five, six, seven, eight, or more arches <NUM> are contemplated. Any one or more of the edges, including all of the edges, of the spring <NUM> may be rounded, radiused, mitered, blunted, or sharp. As shown in <FIG> and <FIG>, the shape-memory spring <NUM> may be rectangular, yet relatively narrow in its width and substantially flat or straight at temperatures below the activation temperature, and then assume one arch <NUM> (e.g., <FIG>), or a plurality of arches 416a, 416b, as shown in <FIG> at the activation temperature.

The spring <NUM> may optionally comprise one or more connectors <NUM>, which may facilitate connection of the spring <NUM> to another structure, including an implant <NUM> (discussed in more detail below). As shown in <FIG>, for example, the spring <NUM> may comprise two connectors 418a and 418b, which may be posts 418a and 418b, and which may be located proximate to the first end <NUM> and second end <NUM>. As shown in <FIG>, for example, the connectors 418a and 418b may comprise holes 418a and 418b in some aspects, which may be located proximate to the first end <NUM> and second end <NUM>.

In some aspects, the spring <NUM> comprises at least one slot <NUM> in the mid-section <NUM>, for example, as shown in <FIG>. Thus, when the spring <NUM> assumes its thermal memory shape (<FIG>), the spring <NUM> comprises two or more arches 416a and 416b, which are separated by the slot <NUM> between them. <FIG> also show the spring <NUM> as comprising a plurality of connectors 418a-f, which may be a plurality of holes 418a-f (e.g., <FIG>) or posts 418a-f (not shown). The slot <NUM> may be substantially in the center of the spring <NUM>, but may also be positioned more proximal to the ends <NUM> or <NUM>, or the sides.

In some embodiments, the spring <NUM> comprises a solenoid or coil shape, for example, as shown in <FIG> or in <FIG>. The coiled spring <NUM> comprises a plurality of arches <NUM> and a plurality of slots <NUM> between the arches <NUM>. In some aspects, when the spring <NUM> assumes its thermal memory shape (<FIG>), the arches <NUM> expand, thereby enlarging the coil diameter. In some aspects, the coiled spring <NUM> may optionally comprise a first extension arm 430a, extending off of the first end <NUM> and a second extension arm 430b, extending off of the second end <NUM> (<FIG>). These extension arms 430a, 430b may comprise a separate structure connected to the first end <NUM> and second end <NUM>, or may simply be non-coiled portions of the spring <NUM>. When the spring <NUM> assumes its thermal memory shape (<FIG>), the first extension arm 430a and/or the second extension arm 430b extend in a different direction, whether upward, downward, outward, or inward from their relaxed direction. In such embodiments, the arches <NUM> do not expand outward (<FIG>), although in some aspects, the arches <NUM> do expand (in addition to the first extension arm 430a and/or the second extension arm 430b) in a manner similar to that shown in <FIG>.

In some aspects, the spring <NUM> comprises a plurality of arms. For example, as shown in <FIG>, the spring <NUM> may comprise a first spring arm 411a and a second spring arm 411b, which are between the first end <NUM> and second end <NUM>, with the arch <NUM> between the first spring arm 411a and second spring arm 411b. Each spring arm 411a, 411b may include bends. For example, as shown in <FIG>, each spring arm 411a, 411b bends at substantially a right angle outward and near the first end <NUM> and second end <NUM>. The spring <NUM> may also include one or more truss arms 421a, 421b. The first truss arm 421a may comprise a first truss arm end <NUM>, and the second truss arm 421b may comprise a second truss arm and <NUM>. The truss arms 421a, 421b are also comprised of a thermal memory material, which preferably is the same thermal memory material out of which the remainder of the spring <NUM> is comprised. The truss arms 421a, 421b may form a truss arch <NUM> near the mid-section <NUM> between the truss arm ends <NUM> and <NUM>. The truss arms 421a, 421b may be connected to a bridge <NUM>, which may be operably connected to the spring arch <NUM> and truss arch <NUM>, as shown in <FIG>. The bridge <NUM> may, but need not be substantially near the mid-section <NUM> of the spring <NUM> and the mid-section <NUM> of the truss structure. The bridge <NUM> may optionally comprise one or more connectors 418a, 418b such as the holes 418a, 418b shown on <FIG>. The one or more connectors 418a, 418b may comprise posts 418a, 418b (not shown).

When the spring <NUM> shown in <FIG> is activated (e.g., at elevated temperatures), the truss arms 421a, 421b extend or expand. The extension or expansion of the truss arms 421a, 421b may facilitate or force the first spring arm 411a and/or second spring arm 411b in their respective extension or expansion, though in some apects, the truss arms 421a, 421b do not exert any force on the spring arms 411a, 411b. The ends <NUM> and <NUM> of the truss arms 421a, 421b may extend along an internal surface of the first spring arm 411a and second spring arm 411b until they reach a notch <NUM> present on the internal surface of the spring arms 411a, 411b. The ends 420a and <NUM> slide or otherwise embed into/within the notch <NUM> and in doing so, become locked in place. When the ends 420a and <NUM> are locked into the notch <NUM>, each spring arm 411a, 411b becomes locked in its pre-established thermal memory position, and the activated spring <NUM> assumes an expanded state.

In another embodiment, for example, as shown in <FIG>, the spring <NUM> may comprise a first spring arm 411a, a second spring arm 411b, a third spring arm 411c, and a fourth spring arm 411d, which are between sets of the first end 410a, 410b and the second end 414a, 414b, and the spring arms 411a-411d may bend at substantially a right angle outward near the first end 410a, 410b and second end 414a, 414b (<FIG>). The spring <NUM> may also include a plurality of truss arms 421a, 421b, 421c, 421d comprised of a thermal memory material, preferably the same material out of which the remainder of the spring <NUM> is comprised, and forming a plurality of truss arches 426a, 426b, 426c. The truss arms 421a-421b may be connected to a bridge <NUM>, which may be operably connected to the spring arches 416a-d, and the bridge <NUM> may be located substantially near the mid-section <NUM> of the spring <NUM>. The bridge <NUM> may optionally comprise one or more connectors <NUM> (not shown in <FIG>), including posts or holes.

When the spring <NUM> shown in <FIG> is activated (e.g., at elevated temperatures), the truss arms 421a-d extend outward, thereby facilitating or forcing the first spring arm 411a, second spring arm 411b, third spring arm 411c, and fourth spring arm 411d outward, or expanding along with the spring arms 411a-d. The ends 420a-d and 424a-d of the truss arms 421a-d may extend along an internal surface of the first spring arm 411a, second spring arm 411b, third spring arm 411c, and fourth spring arm 411d until they reach a notch 425a-d on the internal surface. The ends 420a-d and 424a-d slide into the notches 425a-d and in doing so, become locked in place. When the ends 420a-d and <NUM> are locked into the notches 425a-d, each spring arm 411a-d becomes locked in its pre-established thermal memory position, and the activated spring <NUM> assumes an expanded state.

The various spring <NUM> embodiments described or exemplified herein have thermal memory properties that may be used, for example, to expand an implant <NUM>. For example, the implant <NUM> may have a compact and expandable configuration, and may transition from the compact configuration to the expanded configuration by way of the spring <NUM>. The spring <NUM> may be positioned within an internal compartment of the implant <NUM>, with the spring <NUM> in its relaxed, non-activated state. When the implant <NUM> is inserted into the body of a patient, and when the spring <NUM> reaches a sufficient temperature within the body (e.g., body temperature), the spring <NUM> activates by expanding or assuming its thermal memory shape. In so doing, the spring <NUM> forces the implant <NUM> into its expanded configuration. The spring <NUM> comprises a compact and expandable configuration (as well as all intermediate expansion distances between the fully compact and fully expanded configurations). At room temperature or other temperature below body temperature, the spring <NUM> is not activated or expanded, and preferably is in a compact form. At an elevated temperature such as body temperature, the spring <NUM> assumes its thermal memory shape, which may include expansion and/or re-shaping.

For example, the implant <NUM> may comprise any interbody spinal implant <NUM>, which may be intended for implantation in the spine as a disc replacement or spinal motion segment replacement, or implantation in the hip, or implantation in the knee, or implantation in the elbow, or implantation in the shoulder, or any other movable joint or load-bearing area of the body. The implant <NUM> may have any shape or configuration, and it is to be understood that the implant <NUM> designs shown in the figures of this specification are intended to show operational principles and potential relationships between the spring <NUM> and the implant <NUM> for illustration purposes only. That is, the implants <NUM> shown are not intended to be limiting, do not represent all possible configurations, and do not necessarily represent actual interbody implants <NUM>. The implants <NUM> may be of any shape, size, and configuration appropriate for the task and location for which they are intended to be implanted, and may expand according to the principles illustrated in the figures.

Implants <NUM> may be made of a durable material such as stainless steel, stainless steel alloy, titanium, or titanium alloy, but can also be made of other durable materials such as, but not limited to, polymeric, ceramic, and composite materials. For example, in certain aspects, the implant <NUM> may be comprised of a biocompatible, polymeric matrix reinforced with bioactive fillers, fibers, or both. Certain implants <NUM> may be comprised of urethane dimethacrylate (DUDMA)/tri-ethylene glycol dimethacrylate (TEDGMA) blended resin and a plurality of fillers and fibers including bioactive fillers and E-glass fibers. Durable materials may also consist of any number of pure metals, metal alloys, or both. Titanium and its alloys are generally preferred for certain embodiments due to their acceptable, and desirable, strength and biocompatibility. Durable materials also include polymers such as PEEK and ultra-high molecular weight polyethylene (UHMWPE), as well as composites of polymers and metals, including composites of titanium and PEEK.

<FIG> show an example of an implant <NUM> in a compact and expanded state, which is mediated by the activation of a thermal memory spring <NUM>. In the example shown, the implant <NUM> is configured to utilize the spring <NUM> shown in <FIG>, although the implant may utilize any spring <NUM> described or exemplified herein.

The implant <NUM> preferably is comprised of two primary sections, a top section <NUM> and a bottom section <NUM>. The top section <NUM> and bottom section <NUM> preferably are not directly connected to each other such that they may be separated when the implant <NUM> expands, as detailed below. The top section <NUM> and bottom section <NUM> may be indirectly connected to each other through at least one movable joint 504a, 504b that bridges the top section <NUM> and bottom section <NUM> together to form the implant <NUM>. When the implant <NUM> is not expanded, the at least one movable joint 504a, 504b is/are substantially closed such that the top section <NUM> and bottom section <NUM> may contact each other or at least be in close proximity to each other, as shown in <FIG>. When the implant <NUM> expands, the at least one movable joint 504a, 504b opens such that the top section <NUM> and bottom section <NUM> separate, but do not become detached from the implant <NUM>. The movable joint 504a, 504b is operably connected to each of the top section <NUM> and bottom section <NUM>. The movable joint 504a, 504b facilitates separation of the top section <NUM> and the bottom section <NUM>, and may do so actively, including moving either or both of the top section <NUM> and the bottom section <NUM> (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for the top section <NUM> and bottom section <NUM> to separate from each other, yet not detach.

The implant <NUM> may be configured to fit the spring <NUM> within the implant <NUM>. For example, the top section <NUM> and bottom section <NUM> may each comprise suitable shapes <NUM> or undercuts <NUM> in which the spring <NUM> is housed. The top section <NUM> and/or bottom section <NUM> may comprise one or more sockets 508a, 508b, which are configured to catch one or more of the first end <NUM>, the second end <NUM>, and/or the arch <NUM> of the spring <NUM> when the spring <NUM> expands, thereby locking the expanded spring <NUM> in place and securing the implant <NUM> in an expanded configuration (<FIG>). Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

<FIG> show an example of an implant <NUM> in a compact and expanded state, which is mediated by the activation of a thermal memory spring <NUM>. In the example shown, the implant <NUM> is configured to utilize the spring <NUM> shown in <FIG>, although the implant <NUM> may utilize any spring <NUM> described or exemplified herein.

The implant <NUM> may comprise an expandable box, with a plurality of sidewalls <NUM>. Each sidewall <NUM> separates from an adjacent sidewall <NUM> as the implant <NUM> expands. The sidewalls <NUM> may comprise panels <NUM>, <NUM>, and may be connected to each other through at least one movable joint <NUM>. The panels <NUM>, <NUM> may be at right angles to each other. The implant <NUM> may comprise a front panel <NUM> and a rear panel <NUM>. The movable joint <NUM> facilitates separation of sidewalls <NUM>, and may do so actively, including moving each sidewall <NUM> away from an adjacent sidewall <NUM> (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for the sidewalls <NUM> to separate from each other, yet not detach.

The implant <NUM> may be configured to fit the spring within the implant <NUM>. For example, the implant <NUM> may comprise a center cavity <NUM>, which may comprise compatible shapes <NUM> or undercuts <NUM> (not shown) in which the spring <NUM> is housed. The center cavity <NUM> may comprise one or more sockets <NUM> (not shown), which are configured to catch the first end <NUM>, second end <NUM>, and/or arch <NUM> of the spring <NUM> when the spring <NUM> expands, thereby locking the expanded spring <NUM> in place and securing the implant <NUM> in an expanded configuration (<FIG>). When the spring <NUM> is activated, and forms the arches 416a, 416b, the arches 416a, 416b push against the sidewalls <NUM>, and force each sidewall <NUM> apart via the movable joints <NUM>, as shown in <FIG>. In addition, the arches 416a, 416b, and/or re-shaping of the spring <NUM> also may optionally force the front panel <NUM> and/or the rear panel <NUM> outward. Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

An arch-forming spring <NUM> may be used with an implant <NUM> as shown in <FIG>. In the example shown, the implant <NUM> is configured to utilize the spring <NUM> shown in <FIG>, although the implant <NUM> may utilize any spring <NUM> described or exemplified herein.

The implant <NUM> preferably is comprised of two primary sections, a top section <NUM> and a bottom section <NUM>. The top section <NUM> and bottom section <NUM> preferably are not directly connected to each other such that they may be separated when the implant <NUM> expands, as detailed below. The top section <NUM> and bottom section <NUM> may be indirectly connected to each other through at least one movable joint <NUM> that holds these sections <NUM>, <NUM> together to form the implant <NUM>. The movable joint <NUM> may comprise a hinge <NUM>. When the implant <NUM> is not expanded, the at least one movable joint/hinge <NUM> is/are substantially closed such that the top section <NUM> and bottom section <NUM> may contact each other or at least be in close proximity to each other, as shown in <FIG>. When the implant <NUM> expands, the at least one movable joint/hinge <NUM> opens such that the top section <NUM> and bottom section <NUM> separate, but do not become detached from the implant <NUM>. The movable joint/hinge <NUM> is operably connected to each of the top section <NUM> and bottom section <NUM>.

The implant may comprise an expansion roller <NUM>. The expansion roller <NUM> is operably connected to the spring <NUM>, for example, by way of the spring connectors <NUM>, and the roller <NUM> may be external to the main body of the implant <NUM>. The spring <NUM> may also be operably connected to a surface of the main body of the implant <NUM>, for example, by way of the spring connectors <NUM>. The spring <NUM> may be connected to either the top section <NUM>, the bottom section <NUM>, or both sections <NUM>, <NUM>. Movement of the expansion roller <NUM> is effectuated by the activation of the thermal memory spring <NUM>. For example, as the spring <NUM> assumes its thermal memory shape, its elongate profile contracts as the arch <NUM> forms, thereby pulling the expansion roller <NUM> toward the main body of the implant <NUM>, eventually forcing the top section <NUM> and bottom section <NUM> apart along the hinge <NUM>, as shown in <FIG>. In some aspects, the internal surfaces of the top section <NUM> and bottom section <NUM> may each comprise suitable undercuts <NUM> (not shown) or sockets <NUM> (not shown), which are configured to engage the expansion roller <NUM>, thereby locking the expansion roller <NUM> in place and securing the implant <NUM> in an expanded configuration (<FIG>). Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

The implant <NUM> preferably is comprised of two primary sections, a top section <NUM> and a bottom section <NUM>. The top section <NUM> and bottom section <NUM> preferably are not directly connected to each other such that they may be separated when the implant <NUM> expands, as detailed below. The top section <NUM> and bottom section <NUM> may be indirectly connected to each other through at least one movable joint <NUM> that bridges the top section <NUM> to the bottom section <NUM> to form the implant <NUM>. When the implant <NUM> is not expanded, the at least one movable joint <NUM> is/are substantially closed such that the top section <NUM> and bottom section <NUM> may contact each other or at least be in close proximity to each other, as shown in <FIG>. When the implant <NUM> expands, the at least one movable joint <NUM> opens such that the top section <NUM> and bottom section <NUM> separate, but do not become detached from the implant <NUM>. The movable joint <NUM> is operably connected to each of the top section <NUM> and bottom section <NUM>. The movable joint <NUM> facilitates separation of the top section <NUM> and the bottom section <NUM>, and may do so actively, including moving either or both of the top section <NUM> and the bottom section <NUM> (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for the top section <NUM> and bottom section <NUM> to separate from each other, yet not detach.

The thermal memory spring <NUM> is placed between the top section <NUM> and the bottom section <NUM>. In some aspects, two thermal memory springs 402a, 402b are placed between the top section <NUM> and the bottom section <NUM>. Each spring 402a, 402b may be placed in an opposing orientation such that when the springs 402a, 402b expand, they expand in opposite directions (<FIG>). In some aspects, one thermal memory spring <NUM> is placed between the top section <NUM> and the bottom section <NUM>, but when the spring <NUM> expands, each arch <NUM> (on either side of the slot <NUM>) expands in an opposite direction relative to the other arch <NUM>. The movable joint <NUM> may be positioned within the slot <NUM> of the springs 402a, 402b, such that arches <NUM> straddle the movable joint <NUM>.

When the spring <NUM> is activated, and forms the arches 416a, 416b (<FIG>), the arches <NUM> push against the underside of the top section <NUM> and bottom section <NUM>, and force the top section <NUM> and bottom section <NUM> apart about the movable joint <NUM>, as shown in <FIG>. Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

The implant <NUM> may comprise an expandable box or cage, with a plurality of sidewalls 512a-d connected to each other through at least one movable joint 504a-d that holds these sidewalls 512a-d together. The internal surfaces of each sidewall 512a-d may comprise a plurality of slots <NUM> or grooves <NUM>. The plurality of arches <NUM> and slots <NUM> of the spring <NUM> fit within these grooves <NUM>, thereby securing the spring <NUM> in place within the interior of the implant <NUM>. The movable joint 504a-d facilitates separation of the sidewalls 512a-d from adjacent sidewalls 512a-d, and may do so actively, including moving the sidewalls 512a-d apart (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for each sidewall <NUM> to separate from an adjacent sidewall <NUM>, yet not detach.

When the spring <NUM> is activated, and the arches <NUM> expand outward, enhancing the diameter of the coil (<FIG>), the arches <NUM> push against the sidewalls <NUM>, and force each sidewall 512a-d apart along each movable joint 504a-d, as shown in <FIG>. Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

The implant <NUM> preferably is comprised of three primary sections, a top section <NUM>, a bottom section <NUM>, and a central section <NUM> between the top section <NUM> and the bottom section <NUM> (<FIG>). The top section <NUM>, bottom section <NUM>, and central section <NUM> preferably are not directly connected to each other such that they may be separated when the implant <NUM> expands, as detailed below. The top section <NUM>, bottom section <NUM>, and central section <NUM> may be indirectly connected to each other through at least one movable joint <NUM> that bridges these sections <NUM>, <NUM>, <NUM> together to form the implant <NUM>. When the implant <NUM> is not expanded, the at least one movable joint <NUM> is/are substantially closed such that the central section <NUM> is in contact with or at least in proximity to the top section <NUM> and bottom section <NUM> as shown in <FIG>. When the implant <NUM> expands, the at least one movable joint <NUM> opens such that the top section <NUM> and bottom section <NUM> separate from the central section <NUM>, but do not become detached from the implant <NUM>. The movable joint <NUM> is operably connected to each of the top section <NUM> and bottom section <NUM>, and in some aspects, to the central section <NUM>. The movable joint <NUM> facilitates separation of the top section <NUM> and the bottom section <NUM>, and may do so actively, including moving either or both of the top section <NUM> and the bottom section <NUM> (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for the top section <NUM> and bottom section <NUM> to separate away from each other and the central section <NUM>, yet not detach.

The top section <NUM>, bottom section <NUM>, and central section <NUM> may each comprise undercuts <NUM> into which the thermal memory spring <NUM> is placed within the implant <NUM>, and optionally may comprise an aperture <NUM> that allows one or more of the ends <NUM>, <NUM> of the spring to extend out of the implant <NUM> (<FIG>). The implant <NUM> may comprise one or more connectors 518a, 518b that connect with the spring connectors <NUM> to affix the spring <NUM> to the implant <NUM> and secure the spring <NUM> in place within the aperture <NUM>. The implant connectors 518a, 518b are preferably present on the central section <NUM>. When the spring <NUM> is activated, the truss arms 421a, 421b extend outward, pushing against the internal walls of each of the spring arms 411a, 411b until the truss arms 421a, 421b engage and lock within the notch <NUM>. The expansion of the spring arms 411a, 411b engage sockets <NUM> or undercuts <NUM> in the inner walls of the top section <NUM> and bottom section <NUM>, and thereby force the top section <NUM> and bottom section <NUM> apart and away from the central section <NUM> (<FIG>). The first end <NUM> and second end <NUM> of the spring <NUM> may extend beyond the outer plane of the top section <NUM> and bottom section <NUM> as shown in <FIG>, but need not extend beyond this outer plane (e.g., through the aperture <NUM>, if an aperture <NUM> is present). If the first end <NUM> and second end <NUM> do extend beyond the outer plane, they may help to engage bone or tissue at the site of implantation, thereby helping to secure the implant <NUM> in place. Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

Extension of the first end <NUM> and second end <NUM> of the spring <NUM> outside of the implant <NUM> may provide for an anti-migration or anti expulsion benefit for the implant <NUM>. For example, when protruding out from the top section <NUM> and/or bottom section <NUM>, the first end <NUM> and second end <NUM> may function as an anchor for the implant <NUM> as each of the first end <NUM> and second end <NUM> will contact bone surfaces, and embed into the bone. Engaging the bone will substantially reduce or eliminate the risk of the implant <NUM> becoming dislodged or otherwise moving into a different position or location. The engagement of the and first end <NUM> and second end <NUM> with the bone surface may, in some aspects, form a connection with the bone akin to a screw-in connection with the bone. Thus, the protruding first end <NUM> and second end <NUM>, in contacting opposing bone surfaces, may aid the healing process, including the reduction of localized stress-induced necrosis.

The implant <NUM> may comprise an expandable box, with a plurality of sidewalls 512a-d. The sidewalls <NUM> may comprise panels <NUM>, <NUM>, and may be connected to each other through at least one movable joint <NUM>. The panels <NUM>, <NUM> may be at right angles to each other. The movable joint <NUM> facilitates separation of sidewalls <NUM>, and may do so actively, including moving each sidewall <NUM> away from an adjacent sidewall <NUM> (e.g., the movable joint <NUM> may be actuated by the expansion of the spring <NUM> into its thermal memory shape), or passively, including simply allowing a platform for the sidewalls <NUM> to separate from each other, yet not detach.

The implant <NUM> may configured to fit the spring <NUM> within the implant <NUM>. For example, the implant <NUM> may comprise a center cavity <NUM>, which may comprise compatible shapes <NUM> or undercuts <NUM> (not shown) in which the spring <NUM> is housed. The center cavity <NUM> may comprise one or more sockets <NUM> (not shown), which are configured to catch the first end 410a,b and second end 424a,b, and/or arch 416a,b of the spring <NUM> when the spring <NUM> expands, thereby locking the expanded spring <NUM> in place and securing the implant <NUM> in an expanded configuration (<FIG>). When the spring <NUM> is activated, the truss arms 421a, 421b, 421c, and 42d extend outward until the truss arms 421a, 421b, 421c, and 42d engage and lock within the notch 425a-d on the internal walls of each of the spring arms 411a, 411b, 411c, and 411d. The expansion of the spring arms 411a, 411b, 411c, and 411d may allow the ends 410a, 410b, 414a, and 414b to engage sockets <NUM> or undercuts <NUM> in the inner cavity <NUM> (underside of each sidewall 112a-d or sub-panel <NUM>, <NUM> thereof), and force each sidewall <NUM> apart from adjacent sidewalls <NUM>, as shown in <FIG>. Expansion of the implant <NUM> as shown may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

<FIG> show another embodiment of the shape-memory spring <NUM>, which comprises a metal with a thermal shape memory. The spring <NUM> comprises a first end <NUM>, a second end <NUM>, and a mid-section <NUM> between the first end <NUM> and second end <NUM>. The spring <NUM> comprises a first spring arm 411a and a second spring arm 411b, and also comprises at least one arch <NUM> within the mid-section <NUM>, and the arch <NUM> may be substantially in the center of the spring <NUM> as shown in <FIG> or may be off-center, or may be more proximal to the first end <NUM> and/or the second end <NUM>. In this embodiment, the arch <NUM> is present in the spring <NUM> in the relaxed state. When the spring <NUM> is activated, the arch <NUM> opens such that at least one of the first spring arm 411a and the second spring arm 411b separate further from each other, for example, as shown in <FIG>.

On the internal surface of at least the first spring arm 411a or the second spring arm 411b, the spring <NUM> comprises at least one truss arm <NUM>, for example, as shown in <FIG>. When the spring <NUM> is in its relaxed state, the truss arm <NUM> may lie substantially flat against the internal surface of the first arm 411a or the second arm 411b, or may be seated/inset within a socket <NUM> in the first arm 411a or the second arm 411b. The truss arm <NUM> may also comprise a portion of the first arm 411a or the second arm 411b that is a cut-out of the first arm 411a or the second arm 411b, thereby allowing the truss arm <NUM> to move independently of the main body of the first arm 411a or second arm 411b. When the spring <NUM> is activated, the truss arm <NUM> extends outward along the internal surface of the opposite spring arm 411a or 411b from which the truss arm <NUM> is connected, and extends until the truss arm end <NUM> enters into the notch <NUM>, which is on the internal surface of the opposite spring arm 411a or 411b from which the truss arm <NUM> is connected (<FIG>), and in doing so, the truss arm <NUM> becomes locked in place. The engagement of the truss arm end <NUM> with the notch <NUM> locks the activated spring <NUM> into an expanded state.

<FIG> show an example of an implant <NUM> in a compact and expanded state, which is mediated by the activation of a thermal memory spring <NUM>. In the example shown, the implant <NUM> is configured to utilize the spring <NUM> shown in <FIG>, although the implant <NUM> may utilize any spring <NUM> described or exemplified herein. <FIG> show an example of an implant <NUM> in a compact and expanded state, which is mediated by the activation of a thermal memory spring <NUM>. In the example shown, the implant <NUM> is configured to utilize the spring <NUM> shown in <FIG>, although the implant <NUM> may utilize any spring <NUM> described or exemplified herein.

The implant <NUM> preferably is comprised of two primary sections, a top section <NUM> and a bottom section <NUM>. The top section <NUM> and bottom section <NUM> preferably are not directly connected to each other such that they may be separated when the implant <NUM> expands, as detailed below. The top section <NUM> and bottom section <NUM> may be indirectly connected to each other through at least one movable joint <NUM> that holds these sections <NUM>, <NUM> together to form the implant <NUM> (not shown). The top section <NUM> and bottom section <NUM> may not be connected to each other at all, even indirectly, such that each of the top section <NUM> and bottom section <NUM> attach directly to one of the spring arms 411a or 411b of the spring <NUM>, with the spring <NUM> serving as an intermediary to form the full implant <NUM> (<FIG>). The top section <NUM> and bottom section <NUM> may not be connected to each other at all such that each of the top section <NUM> and bottom section <NUM> attach directly to one or more of the extension arms 430a or 430b of the spring <NUM>, with the spring <NUM> serving as an intermediary to form the full implant <NUM> (<FIG>). When the implant <NUM> is not expanded, the top section <NUM> and bottom section <NUM> may be in close proximity to each other, as shown in <FIG> and <FIG>.

The thermal memory spring <NUM> is placed between the top section <NUM> and the bottom section <NUM>. As shown in the <FIG>, when the spring <NUM> expands, at least one of the first arm 411a or second arm 411b expands outward from the opposite arm 411a or 411b. As the arm 411a or 411b expands, the top section <NUM> or bottom section <NUM> which is attached to the expanding arm 411a or 411b moves upward and away from the opposite section <NUM> or <NUM> (<FIG>). As shown in the <FIG>, when the spring <NUM> expands, at least one of the extension arms 430a, 430b expands in a direction away from its relaxed position. As the extension arm 430a, 430b expands, the top section <NUM> or bottom section <NUM> which is attached to the extension arm 430a and/or 430b moves upward and away from the opposite section <NUM> or <NUM> (<FIG>). Separation of the top section <NUM> from the bottom section <NUM> may be at a substantially uniform distance along the internal surfaces of the top section <NUM> and bottom section <NUM>, or may be uneven, with one end expanding at a greater distance than the other end, as shown in <FIG> and <FIG>. Expansion of the implant <NUM> as shown in the figures may, for example, allow for the implant <NUM> to fit within the site of implantation, and to engage, as appropriate, bone or tissue in the body to facilitate integration of the implant <NUM>.

Methods of using the thermal memory springs <NUM> and expandable implants <NUM> described herein include implanting an expandable implant <NUM> into a patient in need thereof. Preferably, the implant <NUM> is inserted into the patient in its compact, non-expanded form. For example, the implant <NUM> includes the thermal memory spring <NUM> in its non-activated, non-thermal memory shape or state such that the spring <NUM> is not expanding the implant <NUM>, and the implant <NUM> can be maneuvered through dissected tissue and into the location where it will reside within the body. The implant <NUM>, is therefore preferably implanted while at a temperature that is below the temperature that instigates the transition and/or activation of the spring <NUM> into its thermal memory shape or state, for example, a temperature below that of human body temperature or below <NUM> degrees C. The patient preferably is a human being.

The methods may optionally include warming or heating the implant <NUM> to human body temperature, or to the temperature at which the thermal memory spring <NUM> transitions and/or activates into its thermal memory shape or state. The implant <NUM> may be so warmed or heated after the implant <NUM> has been implanted into and positioned as desired into the location where it will reside in the body so as to facilitate expansion of the implant <NUM>. The implant <NUM> may be warmed or heated according to any suitable methodology. In some aspects, the methods may include warming or heating (e.g., pre-heating) the implant <NUM> to a temperature that is below, yet near to human body temperature or the temperature at which the thermal memory spring <NUM> transitions into its thermal memory shape or state, so as to facilitate further warming or heating at the implantation site, the latter of which brings the implant <NUM> to the thermal memory activation temperature.

The methods may optionally include the steps of incising and dissecting tissue in the body, and may include the step of inserting the implant <NUM> into and through the incision and dissection pathway, and may include the step of inserting the implant <NUM> into the location of implantation, or where the implant <NUM> will reside within the body. The methods may optionally include the step of positioning the implant <NUM> within the location of implantation. Preferably, insertion and positioning of the implant <NUM> within the body are carried out before the implant <NUM> is expanded by warming to the thermal memory transition temperature of the spring <NUM> that is part of the implant <NUM>. The methods may optionally include the step of positioning the implant <NUM> within the location of implantation after the implant <NUM> has expanded.

In some aspects, the methods may further include the step of inserting a bone graft material into the implant <NUM> or subsections thereof, or onto any surface of the implant <NUM> that will contact bone within the body, or onto any other surface of the implant <NUM> where it is desired that the implant <NUM> integrate with new bone or otherwise facilitate new bone growth. Inclusion of a bone graft material may serve to facilitate osteointegration of the implant <NUM>, to reinforce of the implant <NUM>, and to improve bone graft containment. The bone graft material may comprise cancellous autograft bone, allograft bone, demineralized bone matrix (DBM), porous synthetic bone graft substitute, bone morphogenic protein (BMP), or any combination thereof.

The foregoing methods are advantageous as the incision and insertion pathways are minimized relative to traditional procedures in which non-expandable, standard implants are used. The latter procedures require larger incisions and larger tissue dissection as part of the insertion pathway in order to accommodate the larger size of the non-compact, non-expandable implants.

Kits may include any implant <NUM> described or exemplified herein, and instructions for using the implant <NUM> in any method described or exemplified herein. The kits may further include surgical or implantation tools, including but not limited to scalpels, distractors, rasps, implant manipulation tools, and other tools that would be used in the implantation of an implant <NUM> within the body.

Claim 1:
An expandable interbody implant (<NUM>), comprising:
a) a top portion (<NUM>) and a bottom portion (<NUM>) that are not connected to each other and which are each independently operably connected to at least one movable joint (<NUM>) or to a hinge that facilitates movement of at least one of the top portion (<NUM>) and the bottom portion (<NUM>) away from the other portion (<NUM>) or (<NUM>); and
b) at least one thermal memory spring (<NUM>) operably connected to the implant (<NUM>), the thermal memory spring (<NUM>) comprising a thermal memory material that is activated to expand the spring (<NUM>) into a pre-established thermal memory shape at a temperature at or above about <NUM> degrees C, characterized in that expansion of the spring (<NUM>) into the pre-established thermal memory shape moves at least one of the top portion (<NUM>) and the bottom portion (<NUM>) away from the other portion (<NUM>) or (<NUM>) to expand the implant (<NUM>),
said implant (<NUM>) being configured to fit the spring (<NUM>) within the implant (<NUM>) and the top portion (<NUM>) and bottom portion (<NUM>) comprising suitable shapes or undercuts (<NUM>) in which the spring (<NUM>) is housed.