Patent Description:
A large number of patients undergo joint replacement surgery each year. An estimated <NUM>,<NUM> patients in the U. undergo knee arthroplasty annually. Currently, implants made from metal, ceramic and/or ultra-high molecular weight polyethylene (UHMWPE) have been used in orthopedic joint arthroplasty or joint replacement. However, the use of such materials often necessitates high degree of bone and soft tissue sacrifice. For example, for hip replacement the femoral head is often entirely removed and replaced with a metal ball and stem implant. This results in the introduction of greater amounts of implant material into the patient's body which can corrode or may release ions or debris, such as metal ions or wear particles. The ions or particles may remain in the joint area or may travel through the blood to other parts of the body. The implant or the debris or ions it releases may cause bone resorption (osteolysis), inflammation, metal toxicity, pseudo-tumors, pain, and other problems.

As such, flexible polymer implants have been designed as medical implants for adhesion to bone and bone-like structures or surfaces. Some such implants have been designed to replace the current materials for joint replacement. For example, a compliant polymer material can be used as cartilage replacement, which provides a bone sparing alternative to implants made from traditional materials, e.g. ceramic, metal, polyethylene. Artificial cartilage implants can be formed with a lubricious bearing (articulating) surface for replacing cartilage and an attachment surface for fixation of the implant to bone for any joint in the body. In some cases, a hydrated polymer (e.g. hydrogel) material is used for forming the compliant polymer implant. Additionally, these flexible polymeric implants may contain a homopolymer, copolymer, or a fully interpenetrating polymer network (IPN's) and/or semi-interpenetrating polymer network ("semi-IPN's"). Polymer implants may also include accessible chemical functional groups such as amine, hydroxyl, carboxyl, or urethane groups, or combinations of functional groups that can be used to modify the characteristics of the implants. Examples of polymeric materials and implants containing these materials are more fully described in: <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; International Application No. <CIT>; and International Application No. <CIT>. <CIT> discloses a ceramic-on-ceramic prosthetic device coupled to a flexible bone interface and defines the preamble of claim <NUM>.

Another advantage of using polymeric material is the ability to create desirable mechanical properties in an implant. Implants can be created with high mechanical strength and wear-resistance while at the same time providing lubricity. This is particularly advantageous for joint implants where a polymer implant can be implanted on one side of a joint forming a polymer-on-cartilage articulation in the joint. The bone-facing side of the polymer implant can be designed to include a polymeric material providing strength and wear-resistance while the articulation side of the same implant has a hydrated polymer that provides lubricity. Additionally, a joint may include multiple implanted polymer devices where one device mates with another in articulation. Each polymer implant is affixed to respective bone surfaces in the joint and mate in a polymer-on-polymer articulation. The structure and polymeric composition of the implants ensure strength at the bone-facing sides and low friction at the articulation sides.

Although the versatility of polymeric materials has several advantages, one challenge is the difficulty in maintaining the shape and form of a compliant, flexible implant. Unlike metal counterparts, the shape of flexible polymeric materials can bend, distort, or change more easily due to the implant's environment. This is problematic where an unused implant changes shape during storage and is no longer viable for implantation when needed. Furthermore, shape changes during the implantation procedure are potentially dangerous where the form of the implant alters during or after the anchoring process. As such, there is a need for maintaining the desired shape or form of the implant prior to, during, and after delivery and implantation into a patient's body.

In addition to the above, another challenge with a flexible implant is the ability to properly position and affix the implant to a target location. Implants are commonly anchored to a bone or joint space by way of a curable adhesive or cement. Conventional adhesives or cements contain polymethylmethacrylate and involve the curing of the compound into a grout-like material where the adhesive interdigitates with features on the implant (such as grooves) to secure the implant to a surface. Other mechanisms of affixation also include chemical and/or physical adhesion, e.g., covalent bonds formed between reactive functional groups found on the device material or bone and the chemical groups in the adhesive polymer and/or a variety of non-covalent interactions such as absorption (e.g., chemisorption, physisorption), hydrophobic interaction, crystallite formation, hydrogen bonds, pi-bond stacking, van der Waals interactions and physical entanglements between the device and the cured adhesive copolymer (e.g., at the molecular level), mechanical interlocking. Physical adhesion may be the result of in-filling or interdigitating of a bump(s), a depression(s), a groove(s), a pore(s), a rough area(s), a space(s) and/or other surface features. Examples of adhesive compounds that can be used to anchor a flexible polymer implant include those described in<CIT>;<CIT>; and<CIT>.

Generally, such adhesive compounds are applied to a surface of the implant in an uncured form. Then when thermal, chemical, or light-curing is applied to the implant surface, the implant is affixed to the joint surface. A problem that arises with polymer implants is the need to adjust the position or shape of the implant during the curing process.

To address these challenges, embodiments described herein provide systems that facilitate the delivery and attachment of a flexible implant to a bone or bone-like surface. Embodiments described allow an implant to be easily, quickly, and strongly attached to a bone surface with a desired implant shape. Some embodiments may deliver any implant to a bone joint surface, but may be especially useful for delivering and attaching a flexible polymer implant to a bone joint surface. In some examples, the devices and methods may allow an implant to conform to a shape, including an irregular shape, of a bone surface, thereby providing a better fit between the implant and the bone surface.

Also described are methods and devices that can be used to control the curing rate of the adhesive compound to allow repositioning or reshaping of the implant. For example, a user (e.g. physician) may be able to control the start of the attachment procedure such as curing (e.g. curing may be started only after the implant is properly placed in a joint) by using a delivery device with a curing rate feature. Once curing of an adhesive to hold an implant in place is started, then the process may proceed very quickly, reducing the possibility that an implant might move out of position before curing and implant attachment is completed. Moreover, embodiments described provide methods and devices that maintain or mold the shape of the implant during curing to ensure proper fixation. For example, shaping devices are provided to maintain, support, or conform the shape of the implant during adhesion to a joint surface.

Additionally, although embodiments may provide for flexible or compliant implants, the devices, methods, and systems described herein can also be used with an implant having a relatively stiff or rigid structure.

The invention concerns an orthopedic implant delivery system as defined in claim <NUM>.

Alternative embodiments are defined in the dependent claims.

Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the exemplary embodiments, it will be understood that they are not intended to limit the invention to those embodiments. On the contrary, the invention is intended to cover alternatives and modifications, which may be included within the scope of the invention as defined by the appended claims.

Various aspects of the inventions are directed to systems comprising a device for delivering and implanting an orthopedic implant. The device may be configured for use in any joint in the body, including but not limited to shoulder joint, a finger joint, a hand joint, an ankle joint, a foot joint, a toe joint, a knee compartment joint, a patellofemoral joint, a total knee joint, a knee meniscus, a hip joint, a femoral side of a hip joint, an acetabular side of a hip joint, a shoulder or hip labrum, an elbow, an intervertebral facet, or a vertebral joint.

<FIG> shows two exemplary flexible joint implants <NUM>, <NUM> for the hip joint. A first cap shaped implant <NUM> is designed to fit over the femoral head <NUM>. A second implant <NUM> is designed to fit into the acetabulum <NUM>. <FIG> shows the flexible implants <NUM>, <NUM> attached to respective bone surfaces. As shown, the flexible implants <NUM>, <NUM> have mating articulating surfaces. In some embodiments, the flexible joint implants <NUM>, <NUM> comprise a biocompatible polyurethane IPN or semi-IPN. The IPN or semi-IPN may include a hydrophilic, polymer on an articulation side of the implant. The IPN or semi-IPN may include a hydrophilic, net negatively charged polymer on an articulation side of the implant. The IPN or semi-IPN may include a hydrophilic, net negatively charged polymer such as sodium polyacrylate or polyacrylic acid on an articulation side of the implant. The concentration of hydrophilic polymer, net negatively charged polymer, or sodium polyacrylate or polyacrylic acid may change through a thickness of the implant where the highest concentration is at an articulation surface, decreasing with distance from the articulation surface. Additionally, the concentration of the polyurethane may also change across a thickness of the implant where the highest concentration is a bone-facing side. The bone-interfacing side may be substantially stiff compared to the rest of the material. Alternatively, the flexible implant may be comprised of a more flexible layer attached to a stiff backing. Additional details regarding the composition of flexible joint implants are described in:<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; International Application No. <CIT>; and International Application No. <CIT>.

The flexible implant can be anchored to the joint using an adhesive or curable compound such as bone cement. <FIG> shows a cross-section according to some embodiments of the implant where a curable adhesive <NUM> is applied to a surface of the implant <NUM>. The adhesive may be applied by any method including by way of syringe <NUM>. The composition of the implant <NUM> may be uniform throughout or contain a higher concentration of some materials on one end compared to another end. For example, implant <NUM> contains a bone-like stiffer anchoring surface at <NUM> and a cartilage-like hydrated lubricious bearing surface at <NUM>. In some embodiments, a gradient and/or a transition zone <NUM> may exist between the lubricious bearing surface <NUM> and the stiff anchoring end <NUM>. Once the adhesive <NUM> is applied to the anchoring surface <NUM>, the implant with adhesive can be brought into contact with a joint or bone surface <NUM>. Alternatively, in some embodiments, the adhesive can also be applied directly to the joint or bone surface instead or in addition to the implant surface. Light may be applied <NUM> to cure the adhesive thereby attaching the implant to the joint surface. In some embodiments, the implant material permits the sufficient passage of light through a thickness of the implant such that the adhesive is light-cured. In other embodiments, the adhesive may be thermally or chemically cured. Additionally, the curing may take place through a combination of thermal, chemical, or light-curing. Examples of curable compounds that can be used to anchor a flexible polymer implant include those described in: <CIT>;<CIT>; and<CIT>.

The phrases bone cement, curable compound, adhesive, curable adhesive, etc. are not limiting to any particular substances or compounds. Rather, these phrases and terms are broadly meant to refer to any compound that can be used to adhere, anchor, attach, affix, couple, or connect an implant to an implantation site. Such compounds may contain adhesive components. Additionally, some compounds, but not all, may be curable and/or polymerizable. In some cases, the attachment compound is an "ionic" type cements like zinc carboxylate. Additionally, dental cements, adhesives or compounds such as those listed in <FIG> can be used with embodiments described herein. Examples of curable and non-curable compounds that can be used to anchor a flexible polymer implant include those described in: <CIT>;<CIT>; and <CIT>.

Some embodiments provide an implant container for holding the implant prior to use. An implant container according to the disclosure may support, enclose, grip, or hold an implant and prepare the implant for implantation in a joint. An implant container may maintain an implant in an expanded form, a contracted form, folded form, or in between. The container may support one or, more commonly, both sides of the implant. The container may have two (or more) sections; at least two of the sections may be configured for engaging opposite sides of an implant.

<FIG> illustrates one embodiment of an implant container. As shown, the implant container <NUM> comprises a first component <NUM> adapted to receive and hold an implant <NUM>. In <FIG>, the first component <NUM> is a female member having a portion <NUM> designed to receive and surround part of the implant <NUM>. The first component <NUM> can include sufficient volume to accommodate the placement of the implant <NUM> partially or completely into the first component <NUM>. <FIG> shows the implant <NUM> as having a convex outer surface <NUM> that is generally spherical. The first component <NUM> may include an inner volume shaped to accommodate or mate with the outer surface <NUM> of the implant <NUM>.

The container <NUM> also includes a second component <NUM> adapted to engage and hold the implant <NUM>. The second component <NUM> may be a male member or lid designed to mate with the female member or first component <NUM> to enclose the implant <NUM>. As shown in <FIG>, the second component <NUM> includes a surface <NUM> that is configured to engage and hold the implant <NUM>. The implant <NUM> may be held by the second component <NUM> by having the surface <NUM> engage an inner surface <NUM> of the implant <NUM>. Where the implant <NUM> has a concave inner surface <NUM>, the surface <NUM> of second component <NUM> may be spherical and convex to create a mating fit with the implant surface <NUM>. To adequately hold the implant <NUM> onto the second component <NUM>, a vacuum may be created in the contact space between implant surface <NUM> and surface <NUM> to secure the implant <NUM> to the surface <NUM> of the container <NUM>.

Additionally, the second component <NUM> may include a shaping member or component that helps maintain the shape of an engaged implant. For example, as shown in <FIG>, the spherical surface <NUM> is a generally convex protrusion that is sized and shaped to engage an inner surface <NUM> of the implant <NUM>. The convex protrusion <NUM> when inserted into the implant <NUM> supports and maintains the hemispherical implant shape. Supporting and/or maintaining the implant shape may include contracting, deforming, expanding, reshaping, spreading out, or unfolding the implant.

In some embodiments, the shaping member or component may be a device distinct from the container that can be used with or without the container. The shaping member may support and/or maintain the implant shape as described above as a separate device.

Additionally, the second component <NUM> or shaping element protects a surface of the implant <NUM>. As shown in <FIG>, the inner surface <NUM> of the implant <NUM> engages and contacts an outer surface <NUM> of the second component <NUM>. While engaged, the surface <NUM> covers and protects the inner surface <NUM> of the implant <NUM> from damage, especially during delivery and attachment.

<FIG> also illustrates another surface <NUM> of the container <NUM> adapted to engage a delivery tool. The surface <NUM> includes a delivery tool attachment element <NUM>. In some embodiments, the delivery tool attachment element <NUM> is part of the first or second component <NUM>, <NUM>. The attachment element <NUM> is adapted to couple, attach, or engage a delivery tool such as a light delivery instrument. The attachment element <NUM> allows the implant to be delivered to an implantation location while still coupled to part of the container <NUM>. For example, <FIG> shows second component <NUM> with an attachment element <NUM>. <FIG> show placement of the implant <NUM> on the second component <NUM> into the joint space. Delivery tool <NUM> is shown in <FIG> and <FIG> as engaging the attachment element <NUM>. The delivery tool <NUM> couples to the attachment element <NUM> and the second component <NUM> while the implant <NUM> is held onto a surface <NUM> of the second component <NUM>. The delivery tool <NUM> may attach to the attachment element <NUM> in any suitable manner including mating threads.

In further embodiments, the first component <NUM> and the second component <NUM> attach to each other to enclose the implant <NUM>. Sections of a container <NUM> may be held together by any means or mechanical mechanism, including but not limited to an adhesive, a lock-and-key, a clip, a clamp, a magnetic closure, screw threads, and a tape. The attachment may be accomplished by mating threads <NUM> on opposing sides of the components <NUM>, <NUM>. Alternatively, the two components <NUM>, <NUM> may be coupled through an interference or friction fit. Additionally, the container <NUM> may include one or more indentations <NUM> to facilitate the movement of the first and second components <NUM>, <NUM> relative to each other. The indentations may be placed along a perimeter of an outer surface of the components.

Referring to <FIG> and <FIG>, some embodiments provide that some or all portions of the container <NUM> permit the transmission of light. <FIG> and <FIG> show a semi-transparent container <NUM> where the first component <NUM> and second component <NUM> both allow transmission of light through a thickness. In other embodiments, only a portion of the container, such as a portion of the second component <NUM>, allows transmission of light. Such portions may be transparent, semi-transparent, or translucent depending on the materials employed. Where a portion of (but not necessarily all) of the container transmits light, one container section may be configured to deliver any form of energy when connected to an energy (e.g. a light) source. For example, if an adhesive is light-curable, then a portion of the container may be at least semi-transparent to allow passage of light from a light delivery instrument (light source), through the thickness of the implant, and onto a light-curable adhesive pre-polymer to initiate curing. The device enclosure may comprise any transparent, semi-transparent (translucent) material, including, but not limited to glass, polycarbonate, polymethyl methacrylate (PMMA), polymethylpentene (PMP), polystyrene, polysulfone, polypropylene, polyethylene terephthalate (PET), quartz, silicone, or combinations thereof.

As mentioned, <FIG> illustrates examples of delivering and attaching an implant <NUM> using the container <NUM> and delivery tools. <FIG> show the container <NUM> comprising a male side <NUM> with a hemispherical convex protrusion and a female side <NUM> with a hemispherical concave depression. Implant <NUM> is an acetabular implant positioned between the convex and concave aspects of two sections of the container <NUM>. In some embodiments, the three items may be designed and manufactured to precisely fit together and may be packaged and sterilized together.

As shown in <FIG>, the container <NUM> may have other functions in addition to housing an implant, including connecting with a delivery instrument <NUM>. The female side or first component <NUM> of the container may be designed to be easily removed in order to expose the acetabular implant <NUM> in a preferred or precise position for implantation within an acetabular cavity. In other words, the first component <NUM> may be removed without disturbing the position of the implant <NUM>, which remains physically held by the second component <NUM>.

As shown in <FIG>, the delivery instrument <NUM> may be any delivery assistance tool such as a device with an elongated arm to facilitate maneuvering the implant <NUM> into the acetabular joint space. The delivery tool <NUM> includes gripping members or handles <NUM> to allow manipulation of the tool and the implant to the joint. Additionally, the delivery tool may include an arm with twists, bends, or curves to accommodate the positioning and attaching of the implant in the patient's body. The handle <NUM> may include portions that are perpendicular to other portions. Additionally the handle <NUM> may include a U-shaped curve near a distal end of the device <NUM>. The delivery instrument <NUM> may also include a connector <NUM> to connect and attach the delivery instrument to the attachment member <NUM> of the container <NUM>.

In other embodiments, the delivery tool <NUM> is a light delivery instrument configured to provide sufficient light to cure an adhesive on the implant surface. The light delivery instrument may take any shape and be of any material that facilitates placing an implant into a joint. A light delivery tool may be substantially linear, curved, serpentine, or spiral. As shown in <FIG>, the delivery tool <NUM> can be a light delivery instrument with a light applicator <NUM>.

Referring again to <FIG>, the first component <NUM> can be removed from the second component <NUM> of container <NUM>. The second component <NUM> includes an attached acetabular implant <NUM> on a surface of the second component <NUM>. In some embodiments, the second component <NUM> has a surface engaging the implant <NUM> such that the shape of the implant <NUM> is substantially maintained or formed while the implant <NUM> is held on the second component <NUM>. Supporting, conforming, and/or maintaining the implant shape may include contracting, deforming, expanding, reshaping, spreading out, or unfolding the implant. The delivery instrument <NUM> has a connector <NUM> for attaching to the attachment element <NUM> of the second component <NUM>. <FIG> shows the delivery instrument <NUM> attached to the second component <NUM>.

When uncovered by the removal of the first component <NUM>, a curable adhesive may be applied to the implant surface. Once the curable adhesive is applied, a surgeon may take the entire assembly of implant <NUM>, second component <NUM>, and delivery instrument <NUM>, and place or press it into an acetabular cavity <NUM> as shown in <FIG>. An implant <NUM> connected with an assembly may be applied in one motion, without manually adjusting the position and alignment of the implant.

Once in place, the surgeon may hold the assembly in position until the adhesive compound has adequately cured to attach the implant to the joint surface. Thermal, chemical, or light-curing can be used. In the case of thermal curing, the surgeon holds the assembly in position during the curing process. In the case of light-curing, the surgeon may activate a light source (e.g. press a button on the light delivery instrument) to apply light through the distal end of the instrument, through the second component <NUM> and implant <NUM>, and onto an adhesive sandwiched between the implant <NUM> and underlying bone to cure an adhesive and, in turn, anchor the implant <NUM> in place. The delivery instrument <NUM> may include a light applicator <NUM> that provides light for curing. The light applicator <NUM> may include at least one LED or an array of LEDs to provide light. As discussed, the container can comprise a material that allows for the transmission of light through a thickness of the container. Additionally, the implant <NUM> also may comprise a material that similarly allows transmission of light to a surface of the implant. The implant material may be semi-transparent, transparent, or translucent to allow penetration of the light to the implant surface to cure the adhesive. In some embodiments, the light delivery device delivers light sufficient to transmit through the second component <NUM> and the implant <NUM> even where a portion of the light may be absorbed in passage through the materials.

Once the implant <NUM> is attached to the acetabular cavity <NUM>, the delivery instrument <NUM> and attached second component <NUM> of the container are removed. In some embodiments where the implant is attached to the second component <NUM> by vacuum suction, the vacuum may be released or broken to remove implant from the second component <NUM>. For example, in some embodiments, if the vacuum is achieved by using a pump, the pump can be turned off to allow air to re-enter the interface between the second component <NUM> thereby releasing the suction hold. In other embodiments, if the vacuum is achieved by a syringe/plunger mechanism, the plunger can be repositioned to move air back into the interface thereby releasing the suction and allowing the implant to be removed from the second component and/or shaper <NUM>.

In other embodiments, the second component <NUM> may not be part of a container. In such cases, the second component <NUM> is a stand-alone shaping element that maintains, supports, or conforms the shape of the implant when the implant is attached to the shaping element. The shaping element or shaper may be pre-attached or attachable to the implant to facilitate anchoring the implant to a target location.

<FIG> and <FIG> illustrate a delivery and curing system <NUM> with an alternative delivery instrument that is also a light delivery instrument. The described light delivery instrument <NUM> includes a distal end with a connector <NUM> for connecting to an attachment element <NUM> of the second component <NUM> of the container <NUM>. The energy (light) source <NUM> may deliver energy (e.g. light) to the second component <NUM> and implant <NUM> by any mechanism, especially by a mechanism that can be controlled by a user (physician). Any form of energy may be delivered, including but not limited to microwave, infrared, visible light and ultraviolet light. In a particular example, a blue light is delivered.

In some embodiments, the light delivery instrument <NUM> comprises a fiber optic cable <NUM> in a housing <NUM>. The housing <NUM> may, for example, be a metal tubing that terminates on one end in a light diffuser unit <NUM>, and on the other end in a lightguide cable <NUM> that leads to a power unit <NUM>. The lightguide cable <NUM> may connect to the power source <NUM> through a cable socket <NUM>. The light delivery instrument <NUM> may also include gripping members or handles <NUM> to help manipulate the instrument and any attached components to a joint space. The handles <NUM> may be placed along a lateral axis of the instrument <NUM>. The power source may include a start/stop button <NUM>, a timer adjustment button <NUM>, and a countdown timer <NUM> (or any other suitable controls) to help control light transmission and curing rate.

In some embodiments, the second component <NUM> may further comprise a light diffuser <NUM> configured to engage with the light applicator <NUM> such that light projected from a light exit end of the light delivery instrument <NUM> into the second component <NUM> of the container <NUM> is diffused by the diffuser <NUM>. Alternatively, the light diffuser <NUM> may be separate from the container <NUM>, such as comprising part of the light applicator <NUM>. Additionally, in any of the described embodiments, the light applicator can have a cross-sectional diameter between about <NUM> and <NUM>.

As shown in <FIG> and <FIG>, light energy can be generated by a power unit <NUM> and travel through a fiber optic cable <NUM> to be scattered to transmit light through the second component <NUM>, the surface of the second component <NUM>, and the implant <NUM> so that some, most, or all areas of the adhesive adjacent the implant <NUM> are exposed to light. In one specific embodiment, light is scattered radially from a central point by a distal light diffuser unit <NUM> to deliver light evenly in a radial distribution through the second component <NUM>, the implant <NUM>, and onto the light-curable adhesive to thereby cure the adhesive and hold the implant <NUM> in place.

Referring to <FIG>, an alternative implant container <NUM> is shown. The implant container <NUM> comprises a first component <NUM> adapted to receive and surround an implant <NUM> and a second component <NUM> configured to hold and maintain the shape of the implant <NUM>. The second component <NUM> may further include two subcomponents <NUM>, <NUM>. For example, the second component <NUM> can include a lid <NUM> that mates with a shaper <NUM>. <FIG> and <FIG> provide cross-sectional views of the container shown in <FIG>. As shown, the container <NUM> may hold the implant <NUM> by enclosing the implant <NUM> when the first component <NUM> and second component <NUM> are attached or coupled together. For example, <FIG> show mating threads <NUM> for coupling the first and second components <NUM>, <NUM> together.

The shaper <NUM> is adapted to hold and engage the implant. In some embodiments, the shaper has a convex spherical surface <NUM> to engage a concave surface <NUM> of the implant <NUM>. Once engaged, the implant's shape is maintained by the shaper <NUM>. To adequately hold the implant <NUM> onto the shaper <NUM>, a vacuum may be created in the contact space between implant surface <NUM> and surface <NUM> to secure the implant <NUM> to the surface <NUM> of the container <NUM>. In some embodiments, the diameter of a hemispherical shaper is between about <NUM> to <NUM>. In any of the embodiments, the diameter of the shaper may be between about <NUM> and <NUM>.

Additionally, the shaper <NUM> may be removable from the container <NUM> while the implant <NUM> is attached. The shaper <NUM> can include an attachment element <NUM> to allow attachment to a delivery tool. <FIG> and <FIG> show the shaper <NUM> holding implant <NUM>. The shaper <NUM> is attached to a delivery tool <NUM> by screw threads between the attachment element <NUM> on the shaper <NUM> and a connector <NUM> at an end of the delivery tool <NUM>. Although shown as screw threads, any suitable means for attachment can be used such as, but not limited, to an adhesive, a lock-and-key, a clip, a clamp, a magnetic closure, and tape.

In some embodiments, the shaping member or shaper <NUM> may be a separate device from the container that can be used with or without the container. The shaper <NUM> may support and/or maintain the implant shape as described above as a separate device. Additionally, the shaper <NUM> can include an attachment element <NUM> as described for attachment to a delivery tool. In use, the implant <NUM> may be packaged separately or together with the shaper <NUM>. If separate, the implant <NUM> is attached to the surface of the shaper <NUM>. A delivery tool <NUM> can be connected to the shaper <NUM> by the attachment element <NUM>. Once attached, the delivery tool <NUM> can be used to maneuver the implant <NUM> and shaper <NUM> to a target location. In such embodiments, the shaper <NUM> is not necessarily part of a container or a component of the container (although it can be). Moreover, the shaper <NUM> can be reusable.

The delivery tool <NUM> may be a light delivery device or a non-light delivery assist device to help maneuver the shaper <NUM> and attached implant <NUM> to a joint. <FIG> and <FIG> show a non-light delivery tool where the acetabular implant <NUM> can be positioned in an acetabular joint space for attachment. In some embodiments, a vacuum source can be contained in the handle <NUM> of the delivery tool <NUM>.

<FIG> shows a light delivery device <NUM> for attachment to the shaper <NUM>. The light delivery device <NUM> has a connector <NUM> at a light exit end (or working end) of the light delivery device <NUM>. A light applicator <NUM> is also positioned at the light exit end to project light into a connected shaper <NUM>. The light applicator <NUM> includes a LED array <NUM>. In some embodiments, the light delivery device <NUM> may comprise mating threads on the light exit end to attach to a shaper <NUM>. Any means for attachment may be used to connect the light delivery device <NUM> to the shaper <NUM>, including an interference fit or any mechanical mechanism. In other embodiments, the shaper <NUM> is attached to the light delivery device <NUM> by means of vacuum suction of the shaper <NUM> against the delivery device <NUM>.

Referring to <FIG>, some embodiments provide for a light delivery instrument with hemispherical convex shape at the light exit or work end. The light exit end has a spherical cover <NUM> that is transparent, translucent, or semi-transparent to allow light transmission. An array <NUM> of LED/light emitting component(s) <NUM> are housed under the protective spherical covering <NUM>. The LED(s)/light emitting components <NUM> may be set apart by spacers <NUM>. In additional embodiments, the light delivery instrument <NUM> in <FIG> can be placed into a concave portion of an implant to attach the implant to a surface by light-curing a compound between the implant and the surface.

In some embodiments, the implant <NUM> may include surface features such as bump(s), depression(s), groove(s), pore(s), rough area(s), space(s) etc. that a facilitate attachment of the implant <NUM> to the target surface. In some embodiments, bumps are surface features that provide interdigitation anchors for the cement/adhesive. The surface features such as bumps may have a height between about <NUM>-<NUM>. However, the surface features may be smaller or larger than <NUM>-<NUM>. In some embodiments, the shape of the surface features can vary, from hemispherical to square, or cylindrical. Additionally, the surface features can be continuous circumferential grooves or protrusions of any cross section. In some embodiments, the implant (e.g. acetabular implant) has about <NUM> to about <NUM> surface features. In additional embodiments, the implants (e.g. femoral implants) have about <NUM> surface features.

As shown in <FIG>, the surface of the implant <NUM> has grooves and/or bumps <NUM>, <NUM>. The implant surface features may serve to maintain a desired spacing between the anchoring surface of the implant and the bone/attachment surface. For example, the surface features can create a space for adhesive/glue between the implant surface contacting a joint surface. Additionally, the surface features can provide a geometry for enhanced fixation. In some embodiments using bone cement, the surface features provide geometry for the cement to grout/interlock with. For an adhesive it provides additional surface area for chemical bonding. This results in additional resistance to movement or separation/pulling out of the implant after attachment.

Additionally, the shaper or container component <NUM> may also include surface features to facilitate holding the implant onto the shaper <NUM>. For example, <FIG> show grooves <NUM> on the convex surface of the shaper <NUM>. In some embodiments, the grooves <NUM> provide channels to facilitate suction of the implant onto the shaper <NUM> during delivery and curing.

Although described above as a container or a separate shaper for an acetabular implant, it can be appreciated that the implant employed may have any variety of shapes depending on the target location and function of the implant. Likewise, the particular shape of the implant may dictate the shape and components of the container and/or shaper. For the hip joint, the acetabulum has a generally concave surface which generally requires that an artificial cartilage implant also mirror that concave form. To contain an acetabular implant and maintain the implant shape, the container/shaper, as described in embodiments above, would have components such as a shaping element to maintain the concave form of the implant before and/or during the implantation process. Additionally, in any of the described embodiments, the container/shaper and any of its components are reusable.

As another example, <FIG> illustrate a femoral head implant container <NUM> having a first component <NUM> adapted to surround and hold the femoral head implant <NUM> when the first component <NUM> is mated to a second component <NUM>. The femoral head is spherical in shape and articulates with the acetabulum to form a "ball-in-socket" joint. Unlike the acetabulum, the femoral head has a convex surface area. The cartilage on the femoral head covers a surface area of greater than <NUM> degrees. Replacing the cartilage completely requires an implant that also covers this area essentially completely (e.g. covers a surface area greater than <NUM> degrees).

One way to cover the femoral head with an implant while preserving the spherical geometry of the underlying bone is to use an implant that can be pulled down over the maximum diameter of the femoral head. This would require an opening diameter on the implant that can "stretch" to a larger diameter transiently to allow it to clear the maximum diameter of the head. Flexible femoral cartilage replacement implants-in contrast to the rigid, inflexible metallic implants used in the industry today-have the ability to do just that. A femoral head may also be covered by easing, guiding, or wrapping an implant that has an opening or slit around the femoral head. Some embodiments provide for the opening diameter of the implant to be between about <NUM> to about <NUM>.

Referring to <FIG>, the femoral implant container enables the proper positioning, alignment, and anchoring of the implant over the femoral head. <FIG> show a convex first component <NUM> or female side that surrounds and encloses the implant <NUM>. A second component or male side <NUM> attaches to the first component <NUM> to enclose the implant <NUM> within the container. The second component <NUM> includes a convex surface <NUM> that can be inserted into a concave cavity of the femoral implant <NUM>. While inserted into the implant <NUM>, the second component <NUM> can assist in maintaining the desired form of the flexible implant <NUM>. To do so, the convex surface <NUM> may share a shape or dimensions similar to a typical femoral head. Placing the implant <NUM> on the convex surface <NUM> can mold or conform the compliant implant material to a shape more like the destined target location. As shown in <FIG>, the convex surface <NUM> has a convex protrusion that has a diameter between about <NUM> to about <NUM>. The convex surface <NUM> is a partial sphere with a neck connecting the surface <NUM> to a flange or lip <NUM>.

The first component <NUM> may comprise a concave outer enclosure that surrounds the implant <NUM> when the first component <NUM> is attached or coupled to the second component <NUM>. Attachment may be facilitated by any suitable means including mating threads <NUM>, <NUM> on respective components. Sections of a container may be held together by any means or mechanical mechanism, including but not limited to an adhesive, a lock-and-key, a clip, a clamp, a magnetic closure, screw threads, and a tape.

The container <NUM> may also include a third component <NUM> housed within the closed container. The third component <NUM> can be placed around the implant <NUM> such that an inner surface of the third component <NUM> contacts an outer surface of the implant <NUM>. The third component <NUM> may partially or completely surround the outer surface of the implant <NUM>.

In some embodiments, the third component <NUM> also may support, maintain, and/or conform the shape or form of the implant when attached to, surrounding, or engaged to the implant <NUM>. In other embodiments, the third component <NUM> may be part of the first or second component.

As described, in some embodiments, the third component <NUM> may be a shaper that provides shaping support to an attached implant. Although described as a component of the container, the device <NUM> does not have be part of a container. In some embodiments, the device <NUM> can be a shaper that is not a component of any other article. Instead, the device <NUM> can be used as a shaper directly with the implant without the device <NUM> being part of an implant container. Additionally, the non-container shaping device <NUM> may have any or all of the features or characteristics described in the embodiments herein except that the device <NUM> is not part of a container.

<FIG> show cross-sectional views of the implant <NUM> enclosed within a container <NUM>. As shown, the implant <NUM> is partially enclosed between a surface <NUM> of the second component <NUM> and a third component or shaper <NUM>. In some embodiments, a section of the third component or shaper <NUM> may contain an opening or hole <NUM> allowing contact between the implant <NUM> and the first component <NUM>. Alternatively, first component <NUM> may help to enclose the implant without directly contacting the implant <NUM>. This may be the case even where the third component or shaper <NUM> has an opening. For example, the first component <NUM> may have an inner surface designed to receive the implant <NUM> without making direct contact by including space between the inner surface of the first component <NUM> and a surface of the implant <NUM>.

<FIG> also show a convex protruding surface <NUM> of the second component <NUM> inserted into a concave portion of the implant <NUM> where the convex protrusion <NUM> supports, maintains, or conforms the shape of the implant <NUM>. Additionally, in some embodiments, the first component <NUM> has a concave inner surface for contact with the convex outer surface of an implant <NUM> or a third component <NUM>.

Referring to <FIG>, during use, the second component <NUM> may be removed from the first component <NUM> and the third component/shaper <NUM>. In other embodiments, the third component/shaper <NUM> is detachable from the second component <NUM> and/or first component <NUM>. As shown, the third component/shaper <NUM> may be enclosed in the first component <NUM> when the container <NUM> is opened. In some cases, the third component/shaper <NUM> remains connected with an implant <NUM>. In such cases, once the container is opened, the third component/shaper <NUM> may be removed from the first component <NUM>.

<FIG> shows the removed third component or shaper <NUM> connected to the implant <NUM>. In some embodiments, the third component/shaper <NUM> may be split or scored. For example, <FIG>show segmented members <NUM> placed around a circumference of the third component <NUM>. Each of the segmented members <NUM> comprise a pair of longitudinal slots <NUM> with a first end <NUM> and a second end <NUM>. The first end <NUM> is positioned along the longitudinal direction of the third component or shaper <NUM> and the second end positioned along a perimeter of the third component <NUM>. In some embodiments, the third component or shaper <NUM> has a proximal opening <NUM> at a north pole <NUM> along a longitudinal axis <NUM> and a distal opening <NUM>. A perimeter extends along the distal and proximal openings <NUM>, <NUM>. In some embodiments, the longitudinal slots <NUM> are positioned about <NUM> degrees apart from one another. In some embodiments, one or more slots may be at about <NUM>, <NUM>, <NUM> degrees apart. In other embodiments, the distance between the slots <NUM> is not uniform. In other cases, the length of the slots <NUM> may or may not be uniform relative to each other. In other embodiments, the first end <NUM> of each slot <NUM> may be proximally positioned from an opening <NUM> in the third component or shaper <NUM>. In some cases, the first end <NUM> may be positioned distally from the north pole <NUM> or a perimeter around the proximal opening <NUM>.

In further embodiments, the segmented members <NUM> allow an opening <NUM> of the third component or shaper <NUM> to open or expand radially. For example, the third component/shaper <NUM> may be split or segmented in the longitudinal direction anywhere from a few degrees from opening <NUM> to well beyond the equator, which allows for the third component to "open" transiently in the radial direction (like a claw or a petal on a flower). In further embodiments, the third component or shaper <NUM> includes resilient expandable members that allow the third component or shaper <NUM> to move from a first configuration to a radially expanded configuration. The resilient members may also allow the third component or shaper <NUM> to return to the first configuration after expansion. In some cases, the resilient members are biased toward the center of the third component or shaper <NUM>. In further embodiments, the resilient members or expandable members allows an increase in the diameter of the third component or shaper <NUM> when radially expanded.

Additionally or alternatively, the third component or shaper <NUM> may include a plurality of slots, perforations, scores, seals, surface features, any other features or combinations thereof that allow the expanding, bending, or other size changes. In other embodiments, portions of the third component or shaper <NUM> may be hinged, connected, or attached at the north pole like a clam-shell, and may open as the implant <NUM> stretches out while being lowered over the femoral head and close afterwards to surround the implant and femoral head. The material of the third component or shaper <NUM> may be sufficiently flexible, resilient, or rigid to snap back into position after the transient deformation it undergoes. For example, <FIG> show the third component or shaper <NUM> with attached implant <NUM> sliding over the femoral head <NUM>.

In some embodiments, the shaper or third component <NUM> may comprise a spherical portion and a cylindrical portion. <FIG>show an edge <NUM> between the spherical and cylindrical portions. In some embodiments, the edge <NUM> is positioned at the transition between the spherical and cylindrical sections.

As described, in some embodiments, the shaper <NUM> is a stand-alone device that is not a part of another device or a container. For example, the shaping device <NUM> shown in <FIG> may be a part of a container as a component or may be a separate stand-alone device that is not part of a container. The shaper <NUM> may also be provided separate from or together with the implant. The implant may be provided in separate packaging and then attached to the shaper <NUM> for attachment to the target location. In other embodiments, the implant may be provided pre-attached to the shaper <NUM>.

In use, the third component or shaper <NUM> with implant <NUM> is removed from the container <NUM>. Alternatively, where a container is not used, the shaper <NUM> with implant <NUM> may be used alone. A curable adhesive or cement is applied to the surface of the implant that will contact a bone or joint surface (see <FIG>). The affixing compound may also be applied to the surface of the bone directly instead of to the surface of the implant. Alternatively, the compound may be applied to both the implant and the bone surfaces.

<FIG> show the third component or shaper <NUM> surrounding a femoral implant <NUM>. In some embodiments, the femoral implant includes surface features such as bumps <NUM> to facilitate attachment to the target location. In further embodiments, the curable compound may be applied to the bone or joint surface directly. Additionally, the curable compound may be applied to both the target anatomical region as well as the implant.

In addition to maintain or supporting shape, the third component or shaping element <NUM> can protect a surface of the implant <NUM>. For example, referring to <FIG>, the implant <NUM> has a convex outer surface that contacts an inner concave surface of the shaper/component <NUM>. While covered by the shaper/component <NUM>, the outer surface of the implant <NUM> is protected from damage.

As shown in <FIG>, the third component or shaper <NUM> with implant <NUM> may be placed directly onto the femoral head <NUM> once the curable adhesive or compound is applied to the implant surface. Oftentimes, there is a tendency for the anchoring compound to pool in a portion of the implant rather than evenly spreading across the implant surface. In such cases, an adhesive spreading device <NUM> is a delivery instrument/tool that may be used to distribute the adhesive more evenly on the implant surface.

<FIG> show one embodiment of an adhesive spreading device <NUM>. <FIG> shows an adhesive spreading device <NUM> having a handle <NUM> and a head <NUM>. The handle <NUM> may comprise an elongate shaft or arm that is connected to the head <NUM>. The head <NUM> may have a greater width compared to the handle <NUM>. A surface of the head <NUM> distal to the handle <NUM> may be adapted to contact the implant <NUM> directly or indirectly through the third component or shaper <NUM>. In some embodiments, the implant is partially or completely enclosed in a shaping member such as the third component or shaper <NUM> described while the adhesive spreading device <NUM> is used. In other embodiments, the third component or shaper <NUM> has a north pole <NUM> (as described above) about which a proximal opening <NUM> is centered. The head <NUM> of the spreading device <NUM> may have a size configured to allow a portion of the head to contact the implant by passing through the proximal opening <NUM>. <FIG> shows the head <NUM> inserted through the proximal opening <NUM> to contact the implant <NUM>.

Referring again to <FIG>, a user can apply force to the implant surface by pushing down on the adhesive spreading device <NUM>. While the spreading device <NUM> is contacting the implant <NUM> through proximal opening <NUM>, the user can apply a distally directed force toward the femoral head. This distally directed force pushes the implant against the femoral head such that adhesive that is deposited in the contact space between the femoral head and the implant will generally be squeezed outward from the center. As such, the adhesive will be spread across a greater surface area.

In some embodiments, the distally directed pressure alone is not sufficient to adequately spread the adhesive. In such circumstances, a plunger may be used to further distribute the adhesive. <FIG> shows plunger <NUM> attached to the head <NUM> of the spreading device <NUM>. The plunger <NUM> is attached such that it can move longitudinally along the head <NUM> to cover the third component or shaper <NUM> with the implant <NUM> (or the implant alone). <FIG> shows the plunger <NUM> at distal position covering the third component/shaper <NUM> on the femoral head <NUM>. In some embodiments, the plunger <NUM> applies a pressing or compressing force along a contact surface between the plunger <NUM> and the implant <NUM> or the third component or shaper <NUM>. The plunger <NUM> may include an opening to allow movement of the plunger <NUM> along the head <NUM>.

<FIG> show another embodiment of the spreading device <NUM> with a plunger <NUM>. In this embodiment, the plunger <NUM> is attached to a distal portion of the head <NUM>. The plunger <NUM> can be sized and shaped to cover a shaper or container component <NUM> in which an implant <NUM> is attached. <FIG> provide cross-sectional views of the plunger <NUM>, shaper or container component <NUM>, and implant <NUM> assembly. <FIG> show additional components connecting the plunger <NUM> to the head <NUM>. The head <NUM> may comprise a hollow shaft <NUM> with mating threads. The plunger <NUM> may be fastened to the head <NUM> with a bolt or screw <NUM> having corresponding mating threads. Any variety of washers <NUM>, nuts <NUM> and <NUM>, and spacers <NUM> may be used, as is understood in the art, to mechanically connect the head <NUM> to the plunger <NUM>.

In some embodiments, a spring <NUM> is positioned against an inner surface of the plunger <NUM>. The spring <NUM> is configured to abut the inner surface of the plunger <NUM> as well as any surface upon which the plunger <NUM> is applied. The spring <NUM> may be attached to the spreading device <NUM> by way of the bolt <NUM> and/or any additional nuts, washers, etc. In some embodiments, the shaper or container component <NUM> has surface grooves <NUM> or lines corresponding to the contour of the spring <NUM>. When pressed against the shaper or container component <NUM>, the spring <NUM> fits into the grooves <NUM>. The spring <NUM> assists in distributing applied forces along the surface surrounding the north pole <NUM>. As shown in the embodiment of <FIG>, the shaper or container component <NUM> does not have an opening around the north pole <NUM>. Rather, the spreading device <NUM> contacts the shaper or container component <NUM> without contacting the implant <NUM>.

Additionally, the head <NUM> and plunger <NUM> may include flanges <NUM> and <NUM> respectively. A user may hold onto flanges <NUM> or <NUM> to help manipulate the spreading device <NUM>.

When used, a surgeon may maneuver the spreading device <NUM> of <FIG> to a joint space having a shaper or container component <NUM> with attached implant <NUM> on a femoral head <NUM>. The surgeon then places the plunger <NUM> over the shaper or container component <NUM> and exerts a distal force against the shaper or container component <NUM>. The plunger <NUM> is adapted to slide over the shaper or container component <NUM> and apply a pressing or pushing force against the shaper or container component <NUM> and implant <NUM>. Lines <NUM> show the direction of the force in some embodiments. The pressing or pushing force applied helps to spreads the adhesive more evenly on the implant surface and femoral head.

<FIG> show an alternative delivery tool that can be used as an adhesive spreader. The spreading device <NUM> has a handle <NUM> with an outer collar or sleeve <NUM>. The outer sleeve <NUM> may include gripping indentations or members to facilitate manipulation of the tool. The spreading device <NUM> may fit onto a shaper or container component <NUM> with an attached implant <NUM>. The shaper or container component <NUM> may have a proximal opening <NUM> (or may not). Applying force distally against the shaper or container component <NUM> assists in distributing the adhesive more evenly on the implant and joint surfaces.

In embodiments, the handle <NUM> is used first to apply force to the implant <NUM> through opening <NUM> to move the curable compound or adhesive outwardly from the north pole toward the periphery of the implant. Then, the outer sleeve <NUM> may be used to move the compound towards the equator of the implant. Additionally, an outer ring <NUM> may be applied to move the curable compound from the equator to the distal opening of the implant.

In any of the described adhesive spreading devices, the devices may include a plunger element having a diameter between about <NUM> and about <NUM>. In some cases, the plunger element has a diameter between about <NUM> and about <NUM>.

In some embodiments, as mentioned above, an additional form mold <NUM> may be used to support, maintain, or conform the shape of the implant at the implantation site. <FIG> show a hemispherical convex form mold <NUM> that is configured to cover and surround the shaper or container component <NUM>. The form mold <NUM> may include a lip or flange <NUM>. In alternative embodiment, shown in <FIG>, the form mold <NUM> comprises a ring <NUM> surrounding a portion of the shaper or container component <NUM>. The form mold <NUM> and ring <NUM> are removably attachable to an adhesive spreading device <NUM>.

<FIG> show alternative embodiments for spreading a compound along a surface of an implant. For example, <FIG> show a spreading device <NUM> with a roller <NUM> attached to a handle <NUM> by a pin <NUM>. The roller <NUM> has a curved surface configured to accommodate a convex surface of a femoral head implant. The roller <NUM> can apply a force in a top-down direction starting from the north pole <NUM> of the implant. The rolling force distributes adhesive pooled near the north pole <NUM> down the sides of the implant <NUM>. Although shown as a roller <NUM> contacting the implant <NUM> directly, the contact can be indirect through a container or shaper holding the implant. Additionally, the rolling may take place in any direction to spread the adhesive.

Alternatively, the roller <NUM> may have a surface for accommodating any anatomical region or location. For example, the roller may have a surface for accommodating the concave surface of the acetabular cavity. The roller may have a rounded convex shape.

In some embodiments, the rolling device spreads the adhesive by first applying a force against a first implant surface about a north pole of an implant in contact with a curable compound, wherein the force is distally directed relative to the north pole. This force is directed onto the north pole area toward the underlying bone surface. Then another force is applied to spread the adhesive down the sides of the implant. This force may be a top down force starting from a position proximal to the north pole to a position distal of the north pole. The top-down motion may be repeated as needed to roll over substantially the entire implant. In other words, for a spherical implant, the roller can roll from the north pole down to the opening, move over in a step-wise fashion to allow a top-down motion on a section next to the previously rolled section. This can be repeated until the surface area of the implant has been rolled over at least once. In some embodiments, the rolling force is applied indirectly to the implant because the roller is in contact with a shaping element such as the shaper or third component <NUM>. The roller may roll over the third component's outer surface to indirectly apply a spreading force to the implant. In some case, the top-down motion goes from the north pole area to the equator of the implant or shaper. In other cases, the top-down motion travels from the north pole area to a perimeter of the distal opening <NUM>. In some embodiments, the rolling is repeated to spread the curable compound across substantially a majority of the implant's surface in contact with the joint space.

<FIG> shows another embodiment of a rolling device <NUM> for use with an implant having a concave inner surface and a convex bone contact surface. The rolling device <NUM> includes a set of rollers <NUM> attached to a base <NUM> and a tip <NUM>. The rollers <NUM> are attached at an angle such that a cross-section at the base <NUM> is wider than a cross-section at the tip <NUM>. In some embodiments, a container component is in direct contact with the rollers <NUM>. In other embodiments, the rollers <NUM> direct apply force against the inside <NUM> of the implant <NUM>. In other embodiments, the rolling device for use with a femoral head implant where the rollers contact the outer convex articular surface.

Although the spreading devices are described as being used on an implant that is already positioned at a target site, this is not required. In some embodiments, a container component with attached implant may first be connected to a delivery tool such as an adhesive spreading device prior to placement at an implantation site. For example, adhesive spreading device shown in <FIG> with the container component <NUM>, implant <NUM>, and adhesive may be brought together for placement in a hip joint space. The spreading device can be used to maneuver the shaper or container component <NUM> and implant <NUM> onto the femoral head <NUM>. This is advantageous where a thermally curable adhesive is used and body temperature at the joint site may start the curing process. Because the thermal curing process can begin immediately upon implant placement, some of the adhesive may already have cured before a spreading device has been connected to spread the adhesive along the surface of the implant. As such, embodiments contemplated include those which include an implant, container, and delivery tool (e.g. adhesive spreading tool) assembly for placement together into a joint.

In some embodiments, the curing may be initiated by temperature or heat. In other embodiments, curing may be initiated by particular temperatures such as about <NUM> or <NUM>. For example, some standard PMMA bone cement are chemically initiated at room temperature. As discussed, the adhesive can be thermally, light, or chemically cured. <FIG> show embodiments of light delivery instrument that can be used with an implant having a convex outer surface. <FIG> show an energy transmitting device <NUM> for transmitting light to a femoral implant <NUM> in a joint region. The device <NUM> has a handle <NUM> that can house a lightguide cable or a power cable <NUM>. The device <NUM> has two opposing arms <NUM> attached at a distal end of the device <NUM>. The two arms <NUM> have an open configuration shown in <FIG> and a closed configuration shown in the <FIG>. The two arms <NUM> can move from the open to closed configuration by pivoting along or about a hinge <NUM>. In some embodiments, the opposing arms in the closed configuration form a substantially circular arc having an angle between about <NUM> degrees and about <NUM> degrees. In other embodiments, the substantially circular arc has an angle greater than about <NUM> degrees.

Energy (light) may be transmitted or emitted from anywhere (or through anywhere) along the apparatus <NUM>. Energy (light) may be emitted from a distal portion or a distal end. Light may be emitted from one or more (e.g. from one to up to one, two, three, four, five hundred or more) bulbs and/or light emitting diodes (LEDs) <NUM>. The LEDs <NUM> may be placed along a surface of the opposing arms <NUM>. Any number of bulbs or LEDs can be arranged in any configuration or pattern. Energy (light) may be delivered in any configuration or pattern that provides energy (light). Light sources may be spaced apart from one another or may be spirally or radially arranged, including in concentric circles.

In some embodiments, the light source is remote from the light delivery instrument <NUM> and a lightguide cable transmits light from the source to the instrument. In other embodiments, the light source is on the light delivery instrument <NUM> and a power source is connected to the light delivery instrument through a cable <NUM>. In further embodiments, the power source is self-contained on or in the light delivery instrument such as a battery pack.

<FIG> shows the application of light to a curable adhesive on the femoral head <NUM>. In this example, the opposing arms <NUM> have a concave surface for fitting around the femoral head <NUM>. The light delivery device <NUM> may deliver light directly to the adhesive through a thickness of the implant <NUM> or through a thickness of the implant <NUM> and an implant shaper. For example, a shaper or component <NUM> may be attached to support and maintain the shape of the implant while it is unanchored but in contact with the femoral head. The opposing arms <NUM> of the light device <NUM> may close around the shaper or container component <NUM>. Once activated, the light device delivers light through a thickness of the shaper or container component <NUM> and a thickness of the implant <NUM> to reach the contact area between the implant <NUM> and the femoral head <NUM>. Presumably, a curable adhesive is placed in that contact area and will begin curing once light is delivered.

In some embodiments, an energy source (e.g. light source) such as a light diffuser connects with or contacts the shaper or container component or implant to provide adhesive curing energy. The energy source may connect with some, most, or all of the implant, shaper or container component, or portions of both. The light diffuser may connect with less area than an entire surface of the implant and/or container component (or shaper) and may be configured to move and thereby cure different portions of the adhesive at different times. Preferably, however, the light diffuser connects with essentially the entire surface of a shaper or container component that also connects on its other side with the implant. The light diffuser may be a spring-loaded series of petals that contacts or surrounds the shaper or container component and/or implant.

In other embodiments, the light delivery instrument is configured to apply light evenly through the shaper or container component, through the implant, and onto the light-curable adhesive situated between the implant and the bone. In yet another embodiment, the shaper or container component itself may be made of an elastomeric material that is at least semi-transparent, such that the shaper or container component can expand or stretch along with the implant as the two are lowered over the femoral head. The shaper or container component and the implant may be made of semi-transparent, transparent, or translucent materials that allow the passage of light-curing energy through to the light-curable adhesive between the implant and bone.

In further embodiments, the light delivery device may have a convex, concave, flat, and/or wedge shape at a light emitting end. A device may have light sources lined up in a radial configuration, a spiral configuration, along concentric circles, or in a grid pattern. For example, <FIG> shows an energy transmitting device <NUM> with a handle <NUM> and a distal head <NUM> having a regular pattern of bulbs or LEDS <NUM>. Energy or light may be delivered or generated locally, and transmitted to a different region. <FIG> shows the device <NUM> with a light diffuser <NUM> for diffusing light into joint region such as an acetabular joint area.

Additionally, a bulb or LED can be configured to produce any amount of light useful for curing or treatment. A bulb or LED can have any shape and any dimension useful for treatment, including but not limited to circular, oblong, rectangular, curved, flat tipped, smooth tipped, pointy tipped. Light may come from LEDs, bulbs and/or light from a cable (e.g. a fiber optic cable). Light generated locally (e.g. from an LED and/or bulb) or traveled light (e.g. light from a fiber optic cable) may be used separately or together.

Furthermore, an energy (light) delivery instrument may be any size or any shape. It may be any size to connect with a joint region. It may be sized to fit within a joint region or to fit within (or near) a portion or a joint region, or it may be sized larger than a joint region as long as energy (light) may be delivered as desired.

A light source or light delivery device may be powered in any way. For example, power may be generated away from the system or may be generated or stored within the system. A light delivery device may be wireless and may have a stored (e.g. battery) energy (power) source. In one example, the device has a battery and may have a cylindrical, flashlight, or gun shaped light. Power may be delivered using one or more electrical cable(s). A cable may traverse a shaft of the light delivery instrument or may be outside a shaft.

Although the implant containers described have included two or three components, it can be appreciated that the containers may contain any number of subcomponents suitable. Additionally, in any of the embodiments contemplated, components of the container may have a cross-sectional diameter between about <NUM> to about <NUM>. Additionally, the cross-sectional diameter of a container component may be between about <NUM> and about <NUM>. Likewise, for a stand-alone shaper, the cross-sectional diameter may also be between about <NUM> to <NUM> and/or about <NUM> to <NUM>.

Additionally, acetabular and femoral head implants have been discussed as nonlimiting examples above. However, any implant may be contained and anchored according to the methods, systems, and devices described. For example, <FIG>show implants for a shoulder joint. Implant <NUM> is a humeral head implant that can be made from a flexible or compliant material. The humeral head implant <NUM> has a convex outer surface. Implant <NUM> is a shoulder socket or glenoid implant with a concave outer surface. <FIG> shows the humeral head implant <NUM> articulating with the glenoid implant <NUM> at the shoulder joint <NUM>. As an additional example, <FIG> show flexible implants for articular surfaces of the knee joint. <FIG> shows artificial cartilage implant <NUM> covering a condyle of the femur. <FIG> shows artificial cartilage implant <NUM> similarly covering a condyle of the tibia.

Regardless of the implantation location or the target site, the described implants and containers can be used in combination or alone with delivery tools described herein. <FIG> shows a delivery tool <NUM> in contact with an implant <NUM> on an articulating surface of bone <NUM>. The delivery tool <NUM> is in direct contact with the implant <NUM> without a container component attached to the implant <NUM>. In some embodiments, the delivery tool <NUM> is also a shaping tool to allow the implant to conform or take on the shape of the underlying bone. In other embodiments, the delivery tool is a shaper that prescribes, forms, supports, or maintains the shape of the implant. For example, the delivery tool <NUM> may be a shaper with a predetermined shape. When the delivery tool <NUM> is placed against the implant <NUM> and forms the implant shape to the predetermined shape. In other embodiments, the delivery tool <NUM> may shape the implant to shape of the underlying anatomical region.

<FIG> shows another example of anchoring the implant <NUM> to a bone surface without an attached shaper. An implant <NUM> with adhesive <NUM> is applied to a joint surface of bone <NUM> of joint <NUM>. The light delivery device <NUM> is brought into contact with the implant <NUM> as shown in <FIG>. The implant <NUM> is attached to the surface <NUM> by light-curing the adhesive <NUM>. In this embodiment, the shape of the attached implant <NUM> is conformed to the bone surface <NUM> through the curing process. The light device has a convex surface <NUM> that assists in conforming the flexible implant <NUM> to the joint.

Additionally, an implant or coating may be cured onto a bone or joint surface with any of the described delivery instruments. For example, the implant or coating may have a prepolymerization or curing structure like liquid or putty. Once cured, the implant solidifies or stiffens on the joint surface.

Generally, the distal end of a light delivery system can be or can take any shape(s) that allows it to deliver light to an adhesive. In one embodiment, the light delivery instrument <NUM> may end in a "plunger" with a convex surface <NUM> (<FIG>). The light delivery instrument <NUM> may comprise a light emitting end with a fully or semi-transparent material that is also compliant (such as silicone) that can be compressed against a flexible cartilage replacement implant <NUM>, a layer of light-curable adhesive <NUM>, and an apposing bone surface <NUM>. The plunger may deform the flexible implant along the contours of the bone surface <NUM>, so that the implant <NUM> follows (e.g. runs parallel to) the contour of the bone. The light may be applied through the plunger, through the implant <NUM>, and onto the adhesive <NUM>, thereby curing the adhesive <NUM> and fixing the implant <NUM> to the joint surface <NUM> (e.g. bone or cartilage). What results is a cartilage replacement implant that "lines" the surface of a bone just as natural cartilage does. This process enables the resurfacing of-without significant bone removal- a damaged joint surface that is not axisymmetric, such as in the knee, where the femoral condyles and tibial plateaus have complex geometries. In traditional total joint replacement surgery, a significant amount of bone is resected to make room for a pre-molded, rigid metallic implant with precisely engineered, but simplified, mating surfaces of metal and UHMWPE. In some embodiments, a sheet of flexible cartilage replacement material is applied to a contoured bone surface. The sheet contours to the bone surface during curing. In other embodiments, the sheet conforms to the shape of the bone surface covered by the sheet.

In the present invention, the natural contours of the bone can be kept intact by contour-preserving reaming of the bone surface, followed by the adaptation of a flexible implant over and along the preserved contour, and subsequent light-mediated curing and adhesion as described. A simple removal of damaged cartilage may suffice for the application of the device. Alternatively, a plunger can be concave so that the implant is pressed against a convex surface. Alternatively, a plunger can be configured to "roll" or "slide" over an implant, optionally while light is applied so that an implant may be "ironed" onto a joint surface manually. A shape of a plunger in this case can be any (e.g. rectangular, spherical, or cylindrical). A distal end of a light delivery system may have a plurality of ends ("plungers") configured to adapt to the surface of an implant connected with a contour of a joint during implantation.

Methods of using the described systems and devices will now be described in greater detail. Some embodiments provide for methods of replacing cartilage in a joint where the joint area is first prepared by shaping the surface in the joint space. For example, with hip joint replacement, the surface <NUM> of the femoral head may be reamed or shaped to more easily accommodate implant attachment (<FIG>). The femoral head may be reamed by any suitable device <NUM> including those described in <CIT>. In other embodiments, the implantation site preparation may include removing tissue from the location. This may entail negatively pressurizing the joint space (e.g. vacuuming) to remove tissue such as blood, fat, bone, moisture etc. from the site.

Once the bone surface has been adequately shaped, the size of the bone surface may be measured. With a femoral head or convex surface, a ruler, caliper or template gage may be used to measure the size of the head to determine the corresponding size of the implant needed. For an acetabular or concave surface, a joint sizer such as the ones shown in <FIG> may be used. A joint sizer may include a head <NUM> at a distal end of an elongate body <NUM> with a gripping member <NUM> at a proximal end. In some embodiments, the gripping member includes a curved handle <NUM>. The head may have a convex surface configured for insertion into a joint space. The convex end may be designed to fit into a concave joint space to measure the size of the joint space. The head <NUM> may have a spherical shape with a diameter between about <NUM> to about <NUM>. In some embodiments, the head may have a diameter between about <NUM> and about <NUM>. The joint sizer may also provide measurements on the depth of the concave joint space. In some embodiments, the head <NUM> measures the joint space. Additionally, the joint sizer can also provide measurements on the orientation of the prepared surface. In some embodiments, the head <NUM> is placed in the prepared space. The head <NUM> may represent the shape and size of the final implant. For example, if the sizer <NUM> shows overhang then the implant would overhang. If the sizer <NUM> sits in the space too deeply then the implant will sit too deeply. The sizer <NUM> can be manipulated within the space to determine the correct placement of the final implant. The surgeon may use the sizer <NUM> to determine how much version or retroversion and/or antegrade or retrograde is desired in the cup position.

Some embodiments provide for creating surface features such as holes in the bone surface. A drill <NUM> may be used to create holes <NUM> in the bone surface <NUM> (<FIG>). In some embodiments, the drill creates holes with a diameter of about <NUM> and depth of about <NUM>. The number of holes and depth are variable. In some cases, the holes are created to make pockets for receiving the adhesive compound. These pockets can help promote the attachment and adhesion of the implant to the bone surface. <FIG> shows holes <NUM> created on an acetabular surface <NUM>.

Once the implantation site is prepared, an implant can be placed into the site. The implant alone may be brought into direct contact with the joint surface. Alternatively, the implant may be provided in a container, a component of a container, or a shaper. For example, the implant may be provided in a shaping element or holder that supports, maintains, and/or conforms the implant shape to the shaper's shape. <FIG> and <FIG>provide examples of containers and container components that surround and enclose the implant while also helping to maintain, conform, or support the implant shape. Those figures as well as <FIG> also show shapers, e.g. <NUM>, that can be used with or independent of a container. For example, the shaper <NUM> in <FIG> may not be part of another device or container and can be used directly with the implant to support the shape of the implant for attachment to the target site. In other embodiments, the shaper is a component of the container.

Continuing with the femoral head example and referring to <FIG>, the flexible implant <NUM> may be directly brought into contact with a joint surface of the femoral head <NUM>. Alternatively, the flexible implant <NUM> may be contained in a shaper <NUM> when brought into contact with the bone surface. For placement into the joint, the inner concave surface of the implant <NUM> is contacted to the outer convex surface of the femoral head <NUM>.

The shaper <NUM> may be made from an elastomeric or expandable material that can stretch or radially expand. This can be accomplished by a variety of means, including the shown longitudinal slots <NUM> and segmented members <NUM>. During placement, the femoral head implant <NUM> may flex and stretch to slide over <NUM> degrees of the femoral head. In doing so, an attached shaper <NUM> has a portion that radially expands to accommodate the widest area (e.g. area near the equator) of the femoral head <NUM>. In some embodiments, the shaper <NUM> radially contracts once the distal opening <NUM> is past the equator of the femoral head <NUM>. In other embodiments, the shaper has resilient expandable members that are biased toward the center of the shaper such that the shaper can move between an expanded state and an unexpanded state where the shaper is biased toward the unexpanded state. Additionally, a shaper along with the implant may have a smaller size during insertion and a larger size during deployment in the joint, and may be configured to be inserted through a small (e.g. arthroscopic) insert.

In some embodiments, a curable compound is placed on the inner surface of the implant prior to implant placement on the joint space. In other embodiments, adhesive is applied after the implant is placed over the bone surface (e.g. femoral head). In such cases, the adhesive can be injected into the interspace between the implant and the bone at the opening of the implant. In one embodiment, positive or negative pressure may be used to change a shape of a device and/or adhesive. A positive pressure may expand or inflate the implant and pressurize the adhesive. The positive pressure may also close or seal a rim of the implant so that the adhesive cannot migrate or escape. This is a way to prescribe the bearing surface with the mold instead of having the bone surface prescribe the backing surface, which in turn, prescribes the bearing surface.

In other embodiments, the adhesive may be applied to the surface of the implantation site rather than the implant. For example, the adhesive may be applied to the joint or bone surface before the implant is placed on the surface. Alternatively, the adhesive may be placed in the interspace between the implant and bone after the implant is positioned on the target site.

Where an adhesive is not evenly spread over the area between the implant and joint surface, further distribution may be accomplished by applying spreading force to the implant or the container component/shaper <NUM>. One way to do so is to apply a force to the north pole <NUM> of the implant <NUM> or container component/shaper <NUM>. Where the container component/shaper <NUM> has a proximal opening <NUM> over the north pole of the implant, an adhesive spreading device, such as those shown in <FIG>, can apply a distally directed force toward the femoral head. Side forces may be applied to further distribute the adhesive evenly. A distally directed squeezing, pressing, or pushing force may be applied by using a plunger <NUM> over the container component/shaper <NUM> and/or implant. Alternatively, a rolling device, as described above may be used to provide a rolling force from the north pole to the distal end of the implant to spread the adhesive in the area between the implant and bone.

Anchoring the implant to the bone or joint can be accomplished by curing the adhesive between the implant and the bone surface. In some embodiments, the adhesive is a pre-polymer capable or polymerizing to attach the implant to the bone surface. Suitable anchoring compounds include bone cements containing PMMA as well as compounds containing urethane, polyurethane, isocyanate, methyl methacrylate MMA, urethane dimethacrylate UDMA, or any other compounds such as those described in: <CIT>;<CIT>; and<CIT>.

Again, curing can be carried out by thermal, chemical, or light-curing. In some embodiments, a combination of curing techniques may be used. For example, the adhesive may be light and chemically curable. Light may be applied to partially cure the adhesive while the implant is positioned on the bone surface. The surgeon may stop light application prior to complete curing of the adhesive in order to, for example, adjust the position of the implant. Once the adjustment is made, the surgeon may complete curing by applying light or by chemical or thermal curing. In some embodiments, the curing process may be started prior to placing the implant into the joint space but completed once the implant is positioned at the target site.

Where light-curing is used, a light delivery instrument may be used for providing light to the adhesive. In embodiments where the implant alone is on the joint, the light is delivered through a thickness of the implant to reach the adhesive in the space between the implant and joint. In other embodiments, the light penetrates through a transparent, semi-transparent, or translucent section of the implant to reach and cure the adhesive. In further embodiments, the implant may be enclosed partly or completely in a container such as a shaper. The shaper may also comprise portions that allow the penetration or transmission of light through to the implant and to the adhesive. The shaper may also be made out of a semi-transparent, transparent, or translucent to allow transmission of light.

In some cases, the material of the implant or the container may absorb some amount of the light. In such cases, the application of the light may be adjusted to accommodate absorption or other loss that occurs.

In further embodiments, the container component may have a delivery attachment portion for coupling or connecting with a delivery tool. For example, the delivery tool may be an elongate device such as the one shown in <FIG> where the surgeon attaches the connector <NUM> at a distal end of the delivery tool to the attachment member <NUM> of the container <NUM>. The surgeon then uses the delivery tool with attached container <NUM> and implant <NUM> to maneuver the implant into the joint. With thermal curing, the placement of the implant with adhesive into the joint may be sufficient to cure the adhesive. With light-curing, the delivery tool may be a light delivery instrument <NUM> that is attachable to the container or implant. The surgeon can use the light delivery instrument <NUM> to maneuver the connected container component and implant <NUM> with adhesive into a joint space.

Additionally, the rate of the curing process may be controlled. For example, where light is applied for curing, the light may be discontinuously applied - suspended and restarted during polymerization of the adhesive compound. The periodic discontinuous application of light can be used by the surgeon to control the rate of polymerization. Furthermore, the intensity of the light can also be varied to control polymerization rate. In some embodiments, the greater the intensity the faster the cure rate. The cure rate can be controlled or regulated by reducing or increasing or maintaining light intensity (or energy intensity). Ranges of light intensity that can be used to cure include about <NUM> W/cm<NUM> to about 10W/cm<NUM>. In some embodiments, the light comprises ultraviolet light. In other embodiments, the light is a blue light. In some embodiments, the light is visible light.

In further embodiments, it may be advantageous to monitor the temperature of the joint or implant during attachment. The polymerization process may be exothermic and cause heating of the tissues near the implantation site. In the case of light-curing, the intensity of the light may be regulated to avoid dangerous temperature increases or to maintain temperature below a physiological limit.

In some embodiments, the curable compound may be able to form covalent bonds with the implant. For example, the implant and the curable compound may have end groups capable of reacting to create chemical bonds between the implant and the cured adhesive. In further embodiments, the curable compound may partially penetrate through a portion of the implant such that when polymerized, the adhesive polymer may be physically entangled within a portion of the implant. Additionally, the adhesive polymer may form an IPN or semi-IPN within the implant. Moreover, non-covalent bonds such as hydrogen bonds or van der Waals may also be formed between the adhesive and implant. In further embodiments, a portion of the implant may be softened by dissolving, penetrating, or diffusing the adhesive pre-polymer into the implant. For example, portions of a monomer or pre-polymer compound may penetrate and/or diffuse into or through the anchoring surface of the implant and become polymerized in situ forming a continuous phase through and outside the anchoring surface. Any suitable solvent may be used in any of the described embodiments.

An adhesive usable with the described embodiments may be any energy curable material able to connect an implant with a joint surface. In one example, a light-curable adhesive that may be used is a substance whose curing (polymerization and hardening) may be initiated by exposure to light (either visible or ultraviolet) within a relatively short time interval (within about a second to up to several minutes, up to about <NUM> minutes, up to about <NUM> minutes, or up to about <NUM> minutes). Preferably, it is a polymer composite containing acrylic-monomers or derivatives thereof), or a combination of acrylic monomers and acrylate-terminated polymers, such as methyl methacrylate and most preferably a composite of methyl methacrylate (MMA) and acrylate-functionalized polyurethane (PU) oligomers, such as described in: <CIT>;<CIT>; and <CIT>. The end-group of a polyurethane can be any ethylenically unsaturated functional group, including, but not limited to an acrylamide, acrylate, allyl ether, methacrylate, and vinyl. Another material with which this system can be used to anchor an orthopaedic device is PMMA bone cement, which typically comprises MMA monomer and polymeric filler particles, such as polystyrene.

Once the implant is anchored or attached to the target site such as a joint surface, the shaper or container component (if a container was used) can be removed or detached from the implant. This may be accomplished, for example, by releasing a vacuum that holds the implant onto the shaper.

In additional embodiments, the implant may be stiff or rigid or contain stiff or rigid materials. In such cases, the systems, devices, and methods described can be used with a rigid or stiff implant. For example, the implant containers can be used to enclose and protect the implant for storage and attachment. Additionally, a container component or a shaper may support the structure or shape of a rigid implant. The container component or shaper may also protect one or more surfaces of the rigid implant while the implant is attached to the component or shaper. The rigid material may be, for example, a metal, ceramic and/or ultra-high molecular weight polyethylene (UHMWPE).

In an alternative embodiment, the curable compound may form a coating on a bone surface. The curable compound may be a pre-polymer or a polymer precursor that is applied to a joint surface. Once applied, the compound may be molded or shaped to an appropriate form on the surface. The compound is then polymerized on the surface to form a coating on the joint.

Additionally, a system according to the disclosure may comprise any combinations of (<NUM>) an energy-curable (e.g. a light-curable) adhesive, (<NUM>) one or more parts of a device enclosure (optionally including a joint implant), (<NUM>) an energy (e.g. light) source, (<NUM>) an energy delivery instrument, (<NUM>) a connector (e.g. a cable) between an energy delivery instrument and a power source, and (<NUM>) a power source. Alternatively, an energy (light) source may be at the device enclosure or delivery instrument (e.g. may be battery operated or may have power cord to a wall outlet). Any of these items or combinations of these items may be packaged into a surgical kit. An enclosure of the system may enclose an implant or may not enclose an implant. An implant of the system may be in a substantially open or expanded position, or may be in a compact or furled position (or may be in between). One or more containers (e.g. bag, tube, vial) in a kit may contain adhesive; a container may be energy (e.g. light) blocking. Alternatively, an assembled or partially assembled device enclosure may comprise adhesive and implant. A surgical kit may include an instruction for use. A surgical kit may include packaging that may be clear or colored, and may be energy (e.g. light) blocking. In one example, an adhesive and a device enclosure with an implant may be packaged separately. Additionally, in any of the described embodiments, the container, canisters, or packaging for the implants may maintain moisture and prevent dehydration of the implant. In further embodiments, any of the components, devices, containers, shapers, etc. described can be reusable.

Claim 1:
An orthopedic implant delivery system comprising:
a flexible polymer orthopedic implant (<NUM>, <NUM>,<NUM>);
a shaper (<NUM>, <NUM>) adapted to hold the flexible polymer orthopedic implant (<NUM>, <NUM>, <NUM>); and
a delivery instrument (<NUM>) configured for inserting the orthopedic implant (<NUM>, <NUM>, <NUM>) held in the shaper (<NUM>, <NUM>) into a joint of a patient, the delivery instrument comprising a gripping member (<NUM>) sized and configured to allow manipulation of the delivery instrument;
characterized in that:
the shaper (<NUM>, <NUM>) is adapted to maintain, support and conform the flexible polymer orthopedic implant (<NUM>,<NUM>,<NUM>) shape during implant delivery and is
adapted to dictate a final shape of the flexible polymer orthopedic implant (<NUM>, <NUM>, <NUM>) after attachment to a joint is complete.