Patent Description:
Spinal pathologies and disorders such as scoliosis and other curvature abnormalities, kyphosis, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, tumor, and fracture may result from factors including trauma, disease and degeneration caused by developmental conditions, injury and aging. Spinal disorders typically result in symptoms including deformity, pain, nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercise can be effective, however, may fail to relieve the symptoms associated with these disorders. Surgical treatment of these spinal disorders includes correction, fusion, fixation, discectomy, laminectomy and implantable prosthetics. Correction treatments used for positioning and alignment may employ implants such as rods, tethers and bone screws for stabilization of a treated section of a spine. This disclosure describes an improvement over these prior technologies.

<CIT> discloses a spinal construct according to the preamble of claim <NUM>, which is capable of non invasive step-by-step adjustment in response to a changing external magnetic field.

<CIT> discloses a growing rod system for correcting a deformity of an orthopedic structure of a body, and comprises: at least one growing rod assembly including a first longitudinal rod segment, a second longitudinal rod segment, and a fluid actuator that is operable to extend the first and second rod segments longitudinally relative to each other in opposite directions from a retracted position to an extended position, wherein the growing rod assembly is adapted to be mounted within the body and spanning the orthopedic deformity; and at least one fluid delivery assembly including at least one fluid line that is connected to the fluid actuator to deliver an actuating fluid to the fluid actuator to drive the actuator to extend the rod segments.

The present invention provides a spinal construct according to claim <NUM>.

Further embodiments of the present invention are described in the dependent claims <NUM>-<NUM>.

The exemplary embodiments of the system disclosed are discussed in terms of medical devices for the treatment of musculoskeletal disorders and more particularly, in terms of a surgical system and method for treatment of a spine disorder. In some embodiment, the present system can be employed to treat scoliosis in a growing child and utilize a spinal construct, which may include, for example, growing rods, vertical expandable prosthetic titanium ribs, Shilla technique components, vertebral body stapling and/or tethers. In some embodiments, the present system can include limitations based on type and magnitude of spinal deformity effectively treated, age of a patient, and underlying co-morbidities, which may impact outcome. References to "embodiments" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are therefore not part of the present invention.

In some embodiments, the surgical system includes a spinal construct having a self-distracting rod. In some embodiments, the surgical system is configured to distract the spine without fusion to prevent progression of a spinal curvature while allowing a thoracic capacity of a child to develop. In some embodiments, the self-distracting rod is configured to resist and/or prevent a need for surgeries every six months. In some embodiments, the surgical system is inexpensive, simple and avoids manipulated distraction.

In some embodiments, the surgical system includes a self-distracting rod having a lock with a tapered crimp configuration. In some embodiments, the surgical system includes a self-distracting rod having a biasing member, such as, for example, a follower and a spring configured to maintain a load on the rod by removing slack in the spinal construct.

In some embodiments, the surgical system includes a self-distracting rod that is configured to prevent forcing correction of the spine and provides for natural growth. In some embodiments, the surgical system is configured to facilitate screw placement and correction of the spine. In some embodiments, the surgical system includes a self-distracting rod having bearings configured to translate along a taper of a lock. In some embodiments, translation along the taper causes the bearings to apply a force to the rod to prevent the rod from backing up while allowing the rod to extend and/or expand the spinal construct and the spine to grow.

In some embodiments, the spinal construct includes a follower spring configured to apply a force against the rod. In some embodiments, the surgical system includes a self-distracting rod configured to facilitate growth while maintaining a load on the spine without repeated surgeries or doctor visits. In some embodiments, the surgical system includes a self-distracting rod having a locking mechanism configured to facilitate and guide growth while the follower spring applies pressure combining both growth guidance and distraction.

In some embodiments, the surgical system includes a self-distracting rod including for example, ball bearings, a body, an extending rod and a biasing member having a lock mechanism. In some embodiments, the surgical system includes a self-distracting rod having a follower spring configured to apply a pressure to the rod to generate force.

In some embodiments, the force that pushes on the extending rod is generated by a constant pressure. In some embodiments, the surgical system includes a self-distracting rod having a high pressure chamber and a low pressure chamber with a one-way valve disposed therebetween. In some embodiments, a constant pressure is maintained in the lower pressure chamber as the volume changes thereby causing a constant force on the rod.

In some embodiments, the surgical system includes a spinal construct having one or more self-distracting rods configured to provide concurrent extension. In some embodiments, the surgical system includes a spinal construct having at least two self-distracting rods configured for disposal in sequence to increase an extended length, increase force, and allow for rod contouring between the two rod mechanisms. In some embodiments, the spinal construct includes at least two self-distracting rods each having a different spring force. In some embodiments, the differing forces of the self-distracting rods facilitate distraction of a thoracic spine at a different rate than a lumbar spine to resist and/or prevent kyphosis of the spine. In some embodiments, the spinal construct includes a body having at least two self-distracting rods and the body can be made of different materials to change the stiffness of the construct. In some embodiments, the spinal construct includes a first self-distracting rod having a flexible configuration relative to a second self-distracting rod.

In some embodiments, the surgical system includes a self-distracting rod configured to provide opposed distraction. In some embodiments, the surgical system includes at least two self-distracting rods being fixed to an apex of the spine to correct an apex curvature, while allowing and guiding growth and maintaining a constant force on the spine. In some embodiments, the surgical system includes a self-distracting rod to facilitate derotation.

In some embodiments, the surgical system includes a self-distracting rod having a release mechanism. In some embodiments, the release mechanism is configured to facilitate delivery of the self-distracting rod to an operating room in a compressed and/or non-extended configuration such that the rod can be activated to grow without putting an unexpected load on the spine.

In some embodiments, the surgical system is configured for assembly in a compressed orientation and a coupling member, such as, for example, a set screw is engaged with the rod to hold the rod in place. In some embodiments, the set screw is released intra-operatively, slowly in a controlled manner so that no unexpected forces are placed onto the spine. In some embodiments, the surgical system includes a rod that is configured to threadingly engage a body to resist and/or prevent extension of the rod from the body until insertion at a surgical site.

In some embodiments, the surgical system includes a lock that is configured to facilitate extension of the spinal construct while resisting and/or preventing restriction of the spinal construct. In some embodiments, the lock can disengage to allow for growth. In some embodiments, the surgical system includes a mechanism that applies a force to an extending rod to maintain a constant force on the spine by following the growth of the spine. In some embodiments, the surgical system includes an intra-operative release mechanism to initiate extension of the rod in a safe and controlled manner. In some embodiments, the surgical system provides for flexibility of placement to be used in distraction techniques, growth guidance techniques, or combinations of the two techniques. In some embodiments, the surgical system may include force sensors configured to measure a force on the spine and provide feedback to the surgeon. In some embodiments, the surgical system includes a release mechanism that is configured to resorb at precise time periods to initiate a subsequent phase of growth. In some embodiments, the surgical system includes rods having a low friction and/or low wear material to eliminate wear debris.

In some embodiments, the surgical system includes a spinal construct that distracts the spine without fusion to prevent progression of a spinal curve while allowing a thoracic capacity of the child to develop. In some embodiments, the surgical system avoids the need for surgeries every six months to adjust the spinal construct. In some embodiments, the spinal construct includes a body having three bearings configured to translate along a taper of a lock that collapses on the rod and resists and/or prevents the rod from backing up, while allowing the rod to grow. In some embodiments, the spinal construct includes a follower and a spring configured to apply a force to the rod. In some embodiments, the spinal construct is configured to allow growth, but maintain a load on the spine without repeated surgeries or doctor visits.

In some embodiments, one or all of the components of the present surgical system may be disposable, peel-pack, pre-packed sterile devices. One or all of the components of the surgical system may be reusable. The surgical system may be configured as a kit with multiple sized and configured components.

In some embodiments, the present disclosure may be employed to treat spinal disorders such as, for example, degenerative disc disease, disc herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumor and fractures. In some embodiments, the present disclosure may be employed with other osteal and bone related applications, including those associated with diagnostics and therapeutics. In some embodiments, the disclosed system may be alternatively employed in a surgical treatment with a patient in a prone or supine position, and/or employ various surgical approaches to the spine, including anterior, posterior, posterior mid-line, direct lateral, postero-lateral, and/or antero lateral approaches, and in other body regions. The present disclosure may also be alternatively employed with procedures for treating the lumbar, cervical, thoracic and pelvic regions of a spinal column. The system of the present disclosure may also be used on animals, bone models and other non-living substrates, such as, for example, in training, testing and demonstration.

The present disclosure may be understood more readily by reference to the following detailed description of the disclosure taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure. In some embodiments, as used in the specification and including the appended claims, the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references "upper" and "lower" are relative and used only in the context to the other, and are not necessarily "superior" and "inferior".

As used in the specification and including the appended claims, "treating" or "treatment" of a disease or condition refers to performing a procedure that may include administering one or more drugs to a patient (human, normal or otherwise or other mammal), in an effort to alleviate signs or symptoms of the disease or condition. Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment can include reducing acute or chronic inflammation; alleviating pain and mitigating and inducing re-growth of new ligament, bone and other tissues; as an adjunct in surgery; and/or any repair procedure. As used in the specification and including the appended claims, the term "tissue" includes soft tissue, vessels, ligaments, tendons, cartilage and/or bone unless specifically referred to otherwise.

The following discussion includes a description of a surgical system including spinal constructs, implants, surgical instruments, related components in accordance with the principles of the present disclosure. Alternate embodiments are disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to <FIG>, there are illustrated components of a surgical system, such as, for example, a spinal correction system <NUM>.

The components of spinal correction system <NUM> can be fabricated from biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone material and/or their composites. For example, the components of spinal correction system <NUM>, individually or collectively, can be fabricated from materials such as stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, Grade <NUM> titanium, super-elastic titanium alloys, cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUM METAL®), ceramics and composites thereof such as calcium phosphate (e.g., SKELITE™), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO<NUM> polymeric rubbers, polyethylene terephthalate (PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone material including autograft, allograft, xenograft or transgenic cortical and/or corticocancellous bone, and tissue growth or differentiation factors, partially resorbable materials, such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium based ceramics, composites of PEEK with resorbable polymers, totally resorbable materials, such as, for example, calcium based ceramics such as calcium phosphate, tri-calcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe and their combinations. Various components of spinal correction system <NUM> may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference. The components of spinal correction system <NUM>, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of spinal correction system <NUM> may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

Spinal correction system <NUM> is employed, for example, with an open or mini-open, minimal access and/or minimally invasive including percutaneous surgical technique and includes one or more spinal constructs for a correction treatment at a surgical site within a body of a patient, for example, a section of a spine to treat various spine pathologies, such as, for example, adolescent idiopathic scoliosis and Scheuermann's kyphosis. In some embodiments, the components of spinal correction system <NUM> are configured to deliver and introduce components of a spinal construct <NUM> that includes implants, such as, for example, one or more spinal rods, bodies, sleeves, connectors and/or fasteners. Spinal construct <NUM> forms one or more components of a correction treatment and/or correction system <NUM> implanted with tissue for positioning and alignment to stabilize a treated section of vertebrae.

Spinal construct <NUM> includes a body having a sleeve <NUM>. Sleeve <NUM> defines a longitudinal axis X1. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. In some embodiments, sleeve <NUM> has a tubular cross section. In some embodiments, sleeve <NUM> may have an oval, oblong, triangular, square, rectangular, polygonal, irregular, uniform, non-uniform, offset, staggered, undulating, arcuate, variable and/or tapered configuration. Sleeve <NUM> includes an outer surface <NUM>.

The body of spinal construct <NUM> includes a rod <NUM> extending from end <NUM>. Rod <NUM> extends between an end <NUM> and an end <NUM>. In some embodiments, end <NUM> is monolithically formed with sleeve <NUM>. In some embodiments, rod <NUM> is integrally connected or includes fastening elements for connection with sleeve <NUM>. In some embodiments, outer surface <NUM> tapers between end <NUM> and rod <NUM> such that rod <NUM> includes a smaller dimension, such as, for example, a diameter or thickness, than sleeve <NUM>. In some embodiments, sleeve <NUM> and/or rod <NUM> may have a uniform thickness/diameter. In some embodiments, sleeve <NUM> and/or rod <NUM> may have various surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, dimpled, polished and/or textured. In some embodiments, a dimension defined by sleeve <NUM> and/or rod <NUM> may be uniformly increasing or decreasing, or have alternate dimensions along its length. In some embodiments, sleeve <NUM> and/or rod <NUM> may have various lengths. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, as described herein.

Sleeve <NUM> includes an inner surface <NUM> that defines a cavity, such as, for example, a passageway <NUM>. Passageway <NUM> extends axially within sleeve <NUM>. In some embodiments, passageway <NUM> may extend within sleeve <NUM> at alternate orientations, relative to sleeve <NUM>, such as, for example, arcuate, transverse, perpendicular and/or other angular orientations such as acute or obtuse, coaxial and/or may be offset or staggered.

Passageway <NUM> includes an opening <NUM> adjacent end <NUM>. Passageway <NUM> and opening <NUM> are configured for movable disposal of a longitudinal element, such as, for example, a spinal rod <NUM>, as described herein. Rod <NUM> is configured to translate within passageway <NUM> relative to sleeve <NUM>, as described herein. In some embodiments, rod <NUM> is configured for dynamic axial translation relative to sleeve <NUM>, as described herein. Passageway <NUM> has a circular cross section. Surface <NUM> defines a cavity <NUM> for disposal of a portion of a lock <NUM>, as described herein, and a tapered portion <NUM> for engagement with lock <NUM>. In some embodiments, tapered portion <NUM> may include a constant taper throughout a length. In some embodiments, tapered portion <NUM> extends along a discrete length of sleeve <NUM>. In some embodiments, tapered portion <NUM> includes a substantially continuous slope, or may include different slopes along the length.

In some embodiments, passageway <NUM> may have alternate cross section configurations for disposal of alternately shaped spinal rods, such as, for example, oval, oblong, triangular, square, polygonal, irregular, uniform, non-uniform, offset, undulating, arcuate, variable and/or tapered. In some embodiments, inner surface <NUM> may define cross section configurations, such as, for example, mating, engaging and/or different from the cross section of one or more spinal rods disposed within passageway <NUM> such that sleeve <NUM> may limit, resist and/or prevent rotational movement of the one or more spinal rods relative to sleeve <NUM>.

Rod <NUM> extends between an end <NUM> and an end <NUM>. Rod <NUM> includes a surface <NUM> engageable with an inner surface of lock <NUM> to facilitate translation of rod <NUM> relative to sleeve <NUM> in a first direction and to resist and/or prevent translation of rod <NUM> in a second direction, as described herein. In some embodiments, rod <NUM> includes a smaller dimension, such as, for example, a diameter or thickness, than sleeve <NUM>. In some embodiments, rod <NUM> may have a uniform thickness/diameter. In some embodiments, rod <NUM> may have various surface configurations, such as, for example, rough, threaded for connection with surgical instruments, arcuate, undulating, dimpled, polished and/or textured. In some embodiments, rod <NUM> may be equivalent to the size of rod <NUM>. In some embodiments, rod <NUM> may be a different size, such as, for example, having a different diameter than rod <NUM>. In some embodiments, rod <NUM> may be an alternate material than rod <NUM>. In some embodiments, a dimension defined by rod <NUM> may be uniformly increasing or decreasing, or have alternate dimensions along its length. In some embodiments, rod <NUM> may have various lengths. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, as described herein.

End <NUM> is configured for disposal within passageway <NUM>. End <NUM> includes a surface <NUM> configured for connection with a biasing member <NUM>, as shown in <FIG>. Biasing member <NUM> includes a coil spring <NUM> and a follower <NUM>. Follower <NUM> is configured for moveable disposal within sleeve <NUM> and driven or urged in a selected direction under the bias force of spring <NUM> to facilitate translation of rod <NUM>, as described herein. In some embodiments, such translation of rod <NUM> includes expansion of spinal construct <NUM> under the bias force of spring <NUM> to provide a constant pressure to rod <NUM> for growth guidance and distraction. In some embodiments, follower <NUM> includes a T-shaped cross section. In some embodiments, follower <NUM> comprises a piston. In some embodiments, the biasing member may include an elastomeric member, clip, leaf spring, gravity induced configuration, pneumatic configuration, hydraulic configuration and/or manual lever. In some embodiments, follower <NUM> is connected with end <NUM> by a pin <NUM>. In some embodiments, follower <NUM> is monolithically formed with end <NUM>. In some embodiments, follower <NUM> is integrally connected or includes fastening elements for connection with end <NUM>.

Spring <NUM> is disposed within sleeve <NUM> and extends between a surface <NUM> of sleeve <NUM> and a surface <NUM> of follower <NUM>. In some embodiments, surface <NUM> is fixed and surface <NUM> is moveable relative to sleeve <NUM>. In some embodiments, spring <NUM> extends about an extension <NUM> of follower <NUM>. Spring <NUM> applies a force and/or load to surface <NUM> causing follower <NUM> to drive and/or urge rod <NUM> in a direction, as shown by arrow A in <FIG>. As such, rod <NUM> is urged to expand spinal construct <NUM> under a constant force of spring <NUM>. In some embodiments, spring <NUM> facilitates dynamic translation of rod <NUM> during growth. Dynamic translation of rod <NUM> allows spinal construct <NUM> to respond to an active and/or changing spine. For example, as forces and/or force changes are applied to spinal construct <NUM>, such as, for example, patient growth, trauma and degeneration, and/or system <NUM> component creep, deformation, damage and degeneration, one or more components of spinal construct <NUM>, for example, sleeve <NUM>, rod <NUM> and biasing member <NUM> adapt and/or are continuously adjustable with a responsive force to maintain the applied force transmitted from the bone fasteners substantially constant.

In some embodiments, the dynamic biasing force of spring <NUM> facilitates a self-distracting spinal construct <NUM>. Translation of rod <NUM> allows spinal construct <NUM> to selectively adjust its length to accommodate growth to avoid multiple surgeries. In some embodiments, spinal construct <NUM> includes one or more components, as described herein, disposed in a selected orientation, as described herein, to guide growth along a selected path, while maintaining a load on the spine.

Rod <NUM> is engageable with lock <NUM>. Lock <NUM> includes a sleeve <NUM>. Sleeve <NUM> includes an inner surface <NUM> that defines a cavity, such as, for example, a passageway <NUM>. Rod <NUM> extends through passageway <NUM>. Sleeve <NUM> includes a surface <NUM> that defines three openings <NUM> disposed in a spaced apart relation about sleeve <NUM>. Openings <NUM> are equidistantly and circumferentially disposed about sleeve <NUM> for communication with passageway <NUM>. In some embodiments, surface <NUM> defines one or a plurality of openings <NUM>.

Openings <NUM> are configured for disposal of bearings <NUM>. Bearings <NUM> are configured to roll and/or slide between surface <NUM> and tapered portion <NUM> to facilitate translation of rod <NUM> relative to sleeve <NUM> in a direction, as shown by arrow A in <FIG>, and/or expansion of the components of spinal construct <NUM>. In some embodiments, rod <NUM> is translatable relative to sleeve <NUM> and/or the components of spinal construct <NUM> are expandable in a non-locking orientation of spinal construct <NUM>.

Upon translation of rod <NUM> relative to sleeve <NUM> in a direction, as shown by arrows B in <FIG> and/or compression/contraction of the components of spinal construct <NUM>, bearings <NUM> slide/roll into a more narrow space between surfaces <NUM>, <NUM> for an interference and/or frictional engagement therewith to compress and/or crimp rod <NUM> with tapered portion <NUM> to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM> in a direction, as shown by arrows B in <FIG> and/or compression/contraction of the components of spinal construct <NUM>, as described herein. In some embodiments, translation of rod <NUM> relative to sleeve <NUM> and/or compression/contraction of the components of spinal construct <NUM> is resisted and/or prevented in a locked orientation of spinal construct <NUM>. In some embodiments, lock <NUM> is disengageable or removable from a locked orientation. In some embodiments, lock <NUM> is fixed in a locked orientation. In some embodiments, biasing member <NUM> and lock <NUM> are engageable with rod <NUM> and comprise a strut to resist and/or prevent compression/contraction of the components of spinal construct <NUM> in a direction, as shown by arrows B in <FIG>.

Lock <NUM> includes a flange <NUM> circumferentially disposed about sleeve <NUM>. Flange <NUM> includes a surface <NUM>. Cavity <NUM> is configured for disposal of a portion of lock <NUM>, which includes a biasing member, such as, for example, a wave spring <NUM>, as shown in <FIG>. In some embodiments, the biasing member of lock <NUM> may include an elastomeric member, clip, coil spring, leaf spring, gravity induced configuration, pneumatic configuration, hydraulic configuration and/or manual lever.

Spring <NUM> applies a force and/or load to surface <NUM> to drive and/or urge lock <NUM> in a direction, as shown by arrow B in <FIG>, stabilizing motion and/or positioning of lock <NUM> with passageway <NUM>. In some embodiments, spring <NUM> drives and/or urges lock <NUM> to a locked orientation of spinal construct <NUM>. In some embodiments, a stop element, such as for example, a ring <NUM> is disposed with sleeve <NUM> to enhance locking and/or facilitate disposal in a locked orientation of spinal construct <NUM>. In some embodiments, lock <NUM> includes a range of movement and ring <NUM> comprises a limit to facilitate limitation of translation of rod <NUM> in a direction, as shown by arrow B in <FIG>.

In some embodiments, spinal construct <NUM> prevents axial migration of rod <NUM> while maintaining a dynamically movable configuration of rod <NUM>. In some embodiments, rod <NUM> may include a dynamically axially translatable configuration, as described herein, and spinal construct <NUM> may be configured, as described herein, such that spinal construct <NUM> may limit, resist and/or prevent movement in at least one direction of rod <NUM> relative to sleeve <NUM>. Translation of bearings <NUM> along taper portion <NUM> facilitates locking and unlocking of lock <NUM> relative to rod <NUM>.

In some embodiments, spinal construct <NUM> includes a fastener, such as, for example, a bone fastener <NUM> that is fastened with vertebrae V, as shown in <FIG>. In some embodiments, spinal construct <NUM> may include one or a plurality of fasteners. In some embodiments, one or more of bone fasteners <NUM> may be engaged with tissue in various orientations, such as, for example, series, parallel, offset, staggered and/or alternate vertebral levels. In some embodiments, one or more fasteners may comprise multi-axial screws, sagittal angulation screws, pedicle screws, mono-axial screws, uniplanar screws, facet screws, fixed screws, tissue penetrating screws, conventional screws, expanding screws, wedges, anchors, buttons, clips, snaps, friction fittings, compressive fittings, expanding rivets, staples, nails, adhesives, posts, fixation plates and/or posts.

Bone fastener <NUM> comprises a head <NUM> and an elongated shaft <NUM> configured for penetrating tissue. Head <NUM> includes a receiving portion configured for disposal of a longitudinal element, such as, for example, a spinal rod, for example, a rod <NUM> and/or a rod <NUM>. Rods <NUM>, <NUM> are attached with and extend along a posterior portion of vertebrae V.

In some embodiments, rod <NUM> and/or rod <NUM> are connected with heads <NUM> causing a tension in rods <NUM>, <NUM> and/or vertebrae V. In some embodiments, the spinal construct, for example, rods <NUM>, <NUM> and/or a tension thereof is employed to displace, pull, twist or align vertebrae V as part of a correction system and treatment. In some embodiments, end <NUM> of rod <NUM> is fixed with at least one vertebra and end <NUM> is dynamically moveable within passageway <NUM>. In some embodiments, end <NUM> of rod <NUM> is fixed with at least one vertebra.

In some embodiments, spinal construct <NUM> may include one or more tethers. In some embodiments, rod <NUM>, rod <NUM> and/or a tether can have a flexible configuration, which includes movement in a lateral or side to side direction and prevents expanding and/or extension in an axial direction upon fixation with vertebrae. In some embodiments, all or only a portion of rod <NUM>, rod <NUM> and/or a tether may have a semi-rigid, rigid, flexible or elastic configuration, and/or have elastic and/or flexible properties such as the elastic and/or flexible properties corresponding to the material examples described herein. Rod <NUM>, rod <NUM> and/or a tether can include a plurality of separately attachable or connectable portions or sections, such as bands or loops, or may be monolithically formed as a single continuous element.

In assembly, operation and use, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, includes spinal construct <NUM> and is employed with and/or subsequent to a surgical correction procedure, similar to those described herein. Spinal correction system <NUM> may be employed in surgical procedures for treating disorders of the spine, such as, for example, a correction treatment to treat child/adolescent idiopathic scoliosis and/or Scheuermann's kyphosis of a spine. In some embodiments, one or all of the components of spinal correction system <NUM> can be delivered as a pre-assembled device or can be assembled in situ.

The surgical correction treatment including spinal construct <NUM> is used for correction and alignment in stabilization of a treated section of vertebrae V. In use, to create tension along vertebrae V with rods <NUM>, <NUM>, a medical practitioner obtains access to a surgical site including vertebrae V via a posterior surgical approach. In some embodiments, the surgical site may be accessed in any appropriate manner, such as through incision and retraction of tissues. In some embodiments, spinal correction system <NUM> can be used in any existing surgical method or technique including open surgery, mini-open surgery, minimally invasive surgery and percutaneous surgical implantation, whereby vertebrae V is accessed through a mini-incision, or sleeve that provides a protected passageway to the area.

In some embodiments, spinal construct <NUM> includes one or more components, as described herein, disposed in a selected orientation, as described herein, to guide growth along a selected path and/or orientation along vertebrae V, while maintaining a force and/or load on vertebrae V. In some embodiments, one or more components of spinal construct <NUM> are disposed in a selected orientation, as described herein, to create one or more zones of treatment along vertebrae V. For example, spinal construct <NUM> can have at least two distracting bodies, as described herein, disposed in sequence to create a treatment zone that increases an extended length, increases force and/or allows for rod contouring. In another example, spinal construct <NUM> can have at least two distracting bodies, as described herein, having a different spring force such that the differing forces create treatment zones that facilitate distraction of thoracic vertebrae at a different rate than lumbar vertebrae to resist and/or prevent kyphosis of vertebrae V. In another example, spinal construct <NUM> can have at least two distracting bodies, as described herein, made of different materials to create treatment zones having alternate stiffness and/or flexibility. In some embodiments, the materials of the bodies of spinal construct <NUM> may have flexible properties, such as the flexible properties corresponding to the material examples described above, and/or may have a semi-rigid, rigid or elastic configuration, and/or have elastic properties, such as the elastic properties corresponding to the material examples described above. In another example, spinal construct <NUM> can have one or more bodies, as described herein, which create one or more treatment zones to provide opposed distraction. In another example, spinal construct <NUM> can have at least two distracting bodies, as described herein, fixed to a middle of the spine that create one or more treatment zones to correct an apex curvature, while allowing and guiding growth and maintaining a constant force on vertebrae V. In another example, spinal construct <NUM> can have one or more bodies, as described herein, fixed to a middle of the spine that create one or more treatment zones to facilitate derotation of vertebrae V. Spinal construct <NUM> is disposed in a selected orientation with vertebrae V1, V2 in connection with the surgical correction procedure. In some embodiments, one or more spinal constructs <NUM> are disposed in a linear orientation along vertebrae V. In some embodiments, one or more spinal constructs <NUM> are disposed with vertebrae V in alternate orientations relative to each other, such as, for example, parallel, perpendicular, adjacent, co-axial, arcuate, offset, staggered, transverse, angular and/or relative posterior/anterior orientations and/or at alternate vertebral levels.

In some embodiments, spinal correction system <NUM> comprises spinal constructs <NUM> disposed in a bilateral configuration. For example, a bilateral configuration can include a first spinal construct <NUM> affixed to a convex side of each of a plurality of vertebrae V and a second spinal construct <NUM> affixed to a concave side of each of a plurality of vertebrae V. This configuration prevents growth of vertebrae V of the convex side of the spine while allowing for growth and adjustments to the concave side for the correction treatment.

Pilot holes are made in vertebrae V1, V2 of vertebrae V in the selected orientation. Bone fasteners <NUM>, as described herein, are aligned with the pilot holes and fastened with the tissue of vertebrae V1, V2. The components of spinal construct <NUM> are connected with bone fasteners <NUM> and disposed in the selected orientation with vertebrae V1, V2.

End <NUM> of rod <NUM> is fixed with bone fastener <NUM> disposed with vertebra V1. Rod <NUM> is connected with sleeve <NUM>, as described herein, and manipulated to a desired tensioning along vertebrae V. Spinal construct <NUM> is connected with vertebrae V1, V2 in connection with the correction treatment to facilitate displacing, pulling, twisting and/or aligning vertebrae V as part of spinal correction system <NUM>. End <NUM> of rod <NUM> is fixed with bone fastener <NUM> disposed with vertebra V2 such that spinal construct <NUM> is disposed in a linear orientation along vertebrae V.

Rod <NUM> translates, in the direction shown by arrow A in <FIG>, to expand spinal construct <NUM> under the bias force of spring <NUM> to provide a constant pressure to rod <NUM> for growth guidance and distraction. During growth, biasing member <NUM> and/or spring <NUM> react to allow dynamic translation of rod <NUM> to facilitate growth guidance of spinal construct <NUM>. Rod <NUM> is dynamically axially translatable relative to sleeve <NUM> within passageway <NUM>. Dynamic translation of rod <NUM> allows spinal construct <NUM> to respond to an active and/or changing spine. As forces and/or force changes are applied to spinal construct <NUM>, for example, patient growth, trauma and degeneration, and/or spinal correction system <NUM> component creep, deformation, damage and degeneration, rod <NUM>, biasing member <NUM> and/or spring <NUM> adapt with a responsive force to maintain the applied force on vertebrae V substantially constant. The biasing force of spring <NUM> facilitates a self-distracting spinal construct <NUM>. Translation of rod <NUM> allows spinal construct <NUM> to selectively adjust its length to accommodate growth to avoid multiple surgeries.

In some embodiments, the components of spinal correction system <NUM>, such as, for example, spinal construct <NUM>, sleeve <NUM>, biasing member <NUM>, spring <NUM> and/or rods <NUM>, <NUM>, are configured to provide dynamically responsive movement in response to motion of the spine and adjacent anatomical portions due to factors, such as, for example, growth, trauma, aging, natural load bearing and dynamic characteristics of the spine, which may include flexion, extension, rotation and lateral bending, and/or external loads, which may include axial, shear, linear, non-linear, angular, torsional, compressive and/or tensile loads applied to the body of a patient. Lock <NUM> resists and/or prevents translation of rod <NUM> relative to sleeve <NUM>, in the direction shown by arrows B in <FIG> and/or compression/contraction of the components of spinal construct <NUM>, as described herein.

In some embodiments, the components of spinal correction system <NUM>, such as, for example, spinal construct <NUM>, sleeve <NUM>, biasing member <NUM>, spring <NUM> and/or rods <NUM>, <NUM>, include force sensors configured to measure the force on the spine and provide feedback to the surgeon. In some embodiments, rods <NUM>, <NUM> have a low friction/low wear material to eliminate wear debris during expansion and contraction.

In some embodiments, spinal correction system <NUM> includes an agent, for example, which may be disposed, packed, coated or layered within, on or about the components and/or surfaces of spinal correction system <NUM>. In some embodiments, the agent may include bone growth promoting material, such as, for example, bone graft to enhance fixation of the components and/or surfaces of spinal correction system <NUM> with vertebrae. In some embodiments, the agent may include one or a plurality of therapeutic agents and/or pharmacological agents for release, including sustained release, to treat, for example, pain, inflammation and degeneration.

Upon completion of a procedure, the surgical instruments and/or tools, assemblies and non-implanted components of spinal correction system <NUM> are removed and the incision(s) are closed. One or more of the components of spinal correction system <NUM> can be made of radiolucent materials such as polymers. Radiomarkers may be included for identification under x-ray, fluoroscopy, CT or other imaging techniques. In some embodiments, the use of surgical navigation, microsurgical and image guided technologies may be employed to access, view and repair spinal deterioration or damage, with the aid of spinal correction system <NUM>. In some embodiments, spinal correction system <NUM> may include one or a plurality of rods, plates, connectors and/or bone fasteners for use with a single vertebral level or a plurality of vertebral levels.

In some embodiments, the components of spinal correction system <NUM> may be employed to treat progressive idiopathic scoliosis with or without sagittal deformity in either infantile or juvenile patients, including but not limited to prepubescent children, adolescents from <NUM>-<NUM> years old with continued growth potential, and/or older children whose growth spurt is late or who otherwise retain growth potential. In some embodiments, the components of spinal correction system <NUM> may be used to prevent or minimize curve progression in individuals of various ages.

In one embodiment, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes a sleeve <NUM>, similar to sleeve <NUM> described herein, having an inner surface <NUM> that defines a passageway <NUM>. Passageway <NUM> includes an opening <NUM> adjacent an end <NUM>. Passageway <NUM> and opening <NUM> are configured for movable disposal of spinal rod <NUM> described herein. Rod <NUM> is dynamically translatable within passageway <NUM> relative to sleeve <NUM>, similar to that described herein.

Rod <NUM> is configured for connection with a biasing member <NUM>, similar to biasing member <NUM> described herein. Biasing member <NUM> includes a high pressure chamber <NUM> and a low pressure chamber <NUM>. Biasing member <NUM> includes a wall <NUM> that is connected with low pressure chamber <NUM> and end <NUM> of rod <NUM>. In some embodiments, wall <NUM> comprises a piston disposed with low pressure chamber <NUM>.

Biasing member <NUM> includes a fluid F, such as, for example, a pressurized biomaterial and/or a pressurized expanding medium that is disposed with high pressure chamber <NUM> and configured to flow and/or expand from chamber <NUM> to low pressure chamber <NUM> via a one-way valve <NUM>. Valve <NUM> is configured to allow transfer of fluid F from high pressure chamber <NUM> to low pressure chamber <NUM>, and to resist and/or prevent transfer of fluid F from low pressure chamber <NUM> to high pressure chamber <NUM>. In some embodiments, valve <NUM> resists and/or prevents transfer of fluid F from low pressure chamber <NUM> to high pressure chamber <NUM> such that spinal construct <NUM> is self-locking. Pressurized fluid F maintains a constant pressure and/or force applied to wall <NUM>, as described herein, including during relative translation of rod <NUM>, which may modify or increase a volume of chamber <NUM>. In some embodiments, fluid F may include silicone, injectable polymer, sterile water, saline, inflating air and/or other fluids and gases, and/or combinations thereof. In some embodiments, fluid F is introduced from high pressure chamber <NUM> to low pressure chamber <NUM> via valve <NUM> at a pressure in a range of <NUM> pounds per square inch (psi) to <NUM> psi. In some embodiments, fluid F may be introduced from high pressure chamber <NUM> to low pressure chamber <NUM> via valve <NUM> at constant or varied pressure. In some embodiments, valve <NUM> is movable between a vent position and a seal position to facilitate transfer of fluid F.

Wall <NUM> is configured for moveable disposal within sleeve <NUM> and driven or urged in a selected direction under the bias force of pressurized fluid F disposed with low pressure chamber <NUM> to facilitate translation of rod <NUM>, as described herein. Pressurized fluid F disposed with low pressure chamber <NUM> applies a force to wall <NUM> causing wall <NUM> to drive and/or urge rod <NUM> in a direction, as shown by arrow AA in <FIG>. In some embodiments, pressurized fluid F facilitates dynamic translation of rod <NUM> during growth, as described herein. Dynamic translation of rod <NUM> allows spinal construct <NUM> to respond to an active and/or changing spine. For example, as forces and/or force changes are applied to spinal construct <NUM>, such as, for example, patient growth, trauma and degeneration, and/or spinal correction system <NUM> component creep, deformation, damage and degeneration, one or more components of spinal construct <NUM>, for example, sleeve <NUM>, rod <NUM> and biasing member <NUM> adapt with a responsive force to maintain the applied force transmitted from the bone fasteners substantially constant. In some embodiments, spinal construct <NUM> includes biasing member <NUM> and lock <NUM> disposed with surface <NUM>, similar to that described herein.

In one embodiment, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes one or more components, as described herein, disposed in a selected orientation, as described herein, to guide growth along a selected path and/or orientation along vertebrae, while maintaining a load on vertebrae. In some embodiments, one or more components of spinal construct <NUM> are disposed in a selected orientation with vertebrae in connection with a surgical correction procedure to create one or more zones of treatment along vertebrae, similar to that described herein.

Spinal construct <NUM> includes a body having a sleeve <NUM>, similar to sleeve <NUM> described herein. Sleeve <NUM> defines a longitudinal axis X2. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. The body of spinal construct <NUM> includes a rod <NUM>, similar to rod <NUM> described herein, extending from end <NUM>. Rod <NUM> extends between an end <NUM> and an end <NUM>. An outer surface <NUM> of sleeve <NUM> tapers between end <NUM> and rod <NUM> such that rod <NUM> includes a smaller dimension, such as, for example, a diameter in thickness than sleeve <NUM>. End <NUM> is configured for disposal with a passageway of a sleeve <NUM>, similar to sleeve <NUM> described herein.

Sleeve <NUM> includes an inner surface (not shown) that defines a passageway (not shown), similar to passageway <NUM>, as described herein. The passageway of sleeve <NUM> is configured for movable disposal of rod <NUM>, as described herein. Rod <NUM> is configured to translate within the passageway relative to sleeve <NUM>, similar to that described herein. Rod <NUM> is engageable with a lock (not shown), similar to lock <NUM> described herein, to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM>. End <NUM> is configured for disposal within the passageway of sleeve <NUM>. End <NUM> is configured for connection with a biasing member (not shown), similar to biasing member <NUM> described herein.

Spinal construct <NUM> includes sleeve <NUM>, which defines a longitudinal axis X3. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. Sleeve <NUM> includes an inner surface (not shown) that defines a passageway (not shown), similar to passageway <NUM> described herein. The passageway of sleeve <NUM> is configured for movable disposal of rod <NUM>, similar to that described herein. Rod <NUM> is engageable with a lock (not shown), similar to lock <NUM> described herein, disposed with sleeve <NUM> to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM>.

Sleeve <NUM> includes a rod <NUM>, similar to rod <NUM> described herein, extending from end <NUM>. Rod <NUM> extends between an end <NUM> and an end <NUM>. An outer surface <NUM> of sleeve <NUM> tapers between end <NUM> and rod <NUM> such that rod <NUM> includes a smaller diameter than sleeve <NUM>. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, similar to that described herein.

Spinal construct <NUM> is disposed in a selected orientation, for example, sleeves <NUM>, <NUM> are oriented in sequence and/or a serial configuration to guide growth along a selected path and/or orientation along vertebrae, while maintaining a load on vertebrae in connection with a surgical correction procedure, similar to that described herein. Sleeve <NUM> is oriented in series with sleeve <NUM> such that axis X2 is in alignment with axis X3, as shown in <FIG>. In some embodiments, sleeves <NUM>, <NUM> are disposed in a serial orientation to create a treatment zone that extends a length of spinal construct <NUM>, increases force or force resistance to vertebrae and/or allows for rod contouring of the components of spinal construct <NUM>.

Rods <NUM>, <NUM> are configured for dynamic translation during growth, similar to that described herein. Dynamic translation of rods <NUM>, <NUM>, in the same direction, as shown by arrows C in <FIG>, allows spinal construct <NUM> to provide concurrent extension and/or expansion of its components and respond to an active and/or changing spine, similar to that described herein. In some embodiments, the biasing members disposed with sleeves <NUM>, <NUM> are configured with different spring forces and/or rates to create treatment zones. In some embodiments, the treatment zones can comprise a zone that facilitates distraction of a first region of spinal construct <NUM> disposed adjacent, for example, a thoracic portion of the spine at a first rate and a zone that facilitates distraction of a second region of spinal construct <NUM> disposed adjacent, for example, a lumbar portion of the spine at a second, different rate. In some embodiments, the zones provide a varied rate of distraction in the same direction, as shown by arrows C in <FIG>. In some embodiments, this configuration resists and/or prevents kyphosis. In some embodiments, rod <NUM> may include a different material from rod <NUM> and/or rod <NUM> to create treatment zones that alter a stiffness of spinal construct <NUM>, for example, spinal construct <NUM> may be more flexible adjacent rod <NUM>.

In an example, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes one or more components, as described herein, disposed in a selected orientation, as described herein, to guide growth along a selected path and/or orientation along vertebrae, while maintaining a load on vertebrae. One or more components of spinal construct <NUM> are disposed in a selected orientation with vertebrae in connection with a surgical correction procedure to create one or more zones of treatment along vertebrae, similar to that described herein.

Spinal construct <NUM> includes a body having a sleeve <NUM>, similar to sleeve <NUM> described herein. Sleeve <NUM> defines a longitudinal axis X5. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. The body of spinal construct <NUM> includes a rod <NUM>, similar to rod <NUM> described herein, extending from end <NUM>. Rod <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> is monolithically formed with sleeve <NUM>. End <NUM> is configured for connection with a sleeve <NUM>, similar to sleeve <NUM> described herein.

Sleeve <NUM> includes an inner surface (not shown) that defines a passageway (not shown), similar to passageway <NUM> described herein. The passageway of sleeve <NUM> is configured for movable disposal of rod <NUM> described herein. Rod <NUM> is configured to translate within the passageway relative to sleeve <NUM>, similar to that described herein. Rod <NUM> is engageable with a lock (not shown), similar to lock <NUM> described herein, to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM>. End <NUM> is configured for disposal within the passageway of sleeve <NUM>. End <NUM> is configured for connection with a biasing member (not shown), similar to biasing member <NUM> described herein.

Spinal construct <NUM> includes sleeve <NUM>, which defines a longitudinal axis X6. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> of rod <NUM> extends from end <NUM>. End <NUM> is monolithically formed with sleeve <NUM>. In some embodiments, rod <NUM> is integrally connected or includes fastening elements for connection with sleeve <NUM>. An outer surface <NUM> of sleeve <NUM> tapers between end <NUM> and rod <NUM> such that rod <NUM> includes a smaller diameter than sleeve <NUM>.

Sleeve <NUM> includes an inner surface that defines a passageway (not shown), similar to passageway <NUM> described herein. The passageway of sleeve <NUM> is configured for movable disposal of a rod <NUM>, similar to rod <NUM> described herein. Rod <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> is engageable with a lock (not shown), similar to lock <NUM> described herein, to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM>. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, as described herein.

End <NUM> is configured for disposal within the passageway of sleeve <NUM>. End <NUM> is configured for connection with a biasing member (not shown), similar to biasing member <NUM> described herein. Rod <NUM> is configured to translate within the passageway relative to sleeve <NUM>.

Spinal construct <NUM> is disposed in a selected orientation, for example, sleeves <NUM>, <NUM> are oriented in opposing relation to guide growth along a selected path and/or provide opposed distraction along vertebrae, while maintaining a load on vertebrae in connection with a surgical correction procedure, similar to that described herein. Sleeve <NUM> is oriented in opposing relation with sleeve <NUM> such that axis X5 is in alignment with axis X6, as shown in <FIG>. Rods <NUM>, <NUM> are configured for dynamic translation during growth, similar to that described herein. Dynamic translation of rods <NUM>, <NUM>, in opposing directions, as shown by arrows D in <FIG>, allows spinal construct <NUM> to create a treatment zone that provides opposed distraction and/or expansion of its components and responds to an active and/or changing spine, similar to that described herein.

In one example, bone fasteners <NUM> are engaged with vertebrae including fixation adjacent an apex A of a spinal curvature, as shown in <FIG>. Spinal correction system <NUM> is disposed in a bilateral configuration including, such as, for example, a spinal construct <NUM> and a spinal construct 512a. Spinal construct 512a is affixed to a convex side CX of each of a plurality of vertebrae. Spinal construct <NUM> is affixed to a concave side CA of each of a plurality of vertebrae. This configuration prevents growth of vertebrae of convex side CX of the spine while allowing for growth and adjustments to concave side CA for a correction treatment to treat various spine pathologies, such as, for example, adolescent idiopathic scoliosis and Scheuermann's kyphosis.

Spinal constructs <NUM>, 512a are disposed in a selected orientation such that each of spinal constructs <NUM>, 512a includes sleeves <NUM>, <NUM> oriented in opposing relation to guide growth along a selected path and/or provide opposed distraction along vertebrae, while maintaining a load on vertebrae in connection with a surgical correction procedure, as described herein. The opposing forces of the biasing members of sleeves <NUM>, <NUM>, as described herein, create treatment zones that facilitate correction of vertebrae adjacent apex A, while guiding growth. Dynamic translation of rods <NUM>, <NUM>, as described herein, allows spinal constructs <NUM>, 512a to respond to an active and/or changing spine. In some embodiments, rods <NUM>, <NUM> may be keyed to sleeves <NUM>, <NUM> to facilitate derotation of vertebrae. In some embodiments, spinal constructs <NUM>, 512a include a pre-selected curvature having a selected kyphotic curve, which may include curvature in a sagittal plane.

In one embodiment, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes a body having a sleeve <NUM>, similar to sleeve <NUM> described herein. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. The body of spinal construct <NUM> includes a rod (not shown), similar to rod <NUM> described herein. Sleeve <NUM> defines a passageway <NUM>, similar to passageway <NUM> described herein. Passageway <NUM> is configured for movable disposal of rod <NUM> described herein. Rod <NUM> is configured to translate within passageway <NUM> relative to sleeve <NUM> via a biasing member <NUM>, similar to biasing member <NUM> described herein, and is engageable with a lock <NUM>, similar to lock <NUM> described herein.

Sleeve <NUM> includes a surface <NUM> that defines an opening <NUM>. Opening <NUM> is configured for engagement with a release member, such as, for example, a set screw <NUM>. Set screw <NUM> is engageable with sleeve <NUM> and rod <NUM> to dispose spinal construct <NUM> in a selected configuration, setting and/or position. Set screw <NUM> is engageable with a surface of rod <NUM> to facilitate delivery of spinal construct <NUM> to a surgical site such as an operating room, back table, medical facility and/or with a patient body. Set screw <NUM> is threadably engageable with sleeve <NUM> to connect, attach, fix and/or lock, provisionally, removably and/or permanently, rod <NUM> to sleeve <NUM> in a selected configuration, setting and/or position of spinal construct <NUM>.

For example, spinal construct <NUM> can be disposed in a selected configuration, setting and/or position for delivery of spinal construct <NUM> to a surgical site. Rod <NUM> is contracted, collapsed and/or compressed with biasing member <NUM> within sleeve <NUM> to dispose spinal construct <NUM> in a contracted, collapsed and/or compressed configuration. Set screw <NUM> is engaged with sleeve <NUM> and rod <NUM> to provisionally fix rod <NUM> in a non-expandable, contracted, collapsed and/or compressed configuration relative to sleeve <NUM> for delivery of spinal construct <NUM> to a surgical site. In some embodiments, set screw <NUM> may engage the components of spinal construct <NUM> in a friction fit, pressure fit, interference, mating engagement, interlock and/or adhesive. Spinal construct <NUM> is attached with vertebrae, similar to spinal construct <NUM> described herein. Set screw <NUM> is rotated, disengaged and/or removed from the components of spinal construct <NUM> intra-operatively in a controlled manner to avoid unexpected forces being applied to the vertebrae. In some embodiments, set screw <NUM> may disengage or be removed from the components of spinal construct <NUM> gradually. Disengagement or removal of set screw <NUM> from the components of spinal construct <NUM> releases spinal construct <NUM> from the selected configuration, setting and/or position to activate and/or release rod <NUM> such that rod <NUM> can dynamically translate and/or expand spinal construct <NUM>, similar to that described herein. In some embodiments, spinal correction system <NUM> includes a release mechanism engageable with the components of spinal construct <NUM> and is resorbable at precise time periods to initiate a next phase of growth of vertebrae.

In one embodiment, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes a body having a sleeve <NUM>, similar to sleeve <NUM> described herein. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. The body of spinal construct <NUM> includes a rod (not shown), similar to rod <NUM> described herein. Sleeve <NUM> defines a passageway <NUM>, similar to passageway <NUM> described herein. Passageway <NUM> is configured for movable disposal of a rod <NUM>, similar to rod <NUM> described herein. Rod <NUM> is configured to translate within passageway <NUM> relative to sleeve <NUM>, similar to that described herein.

Rod <NUM> extends between an end <NUM> and an end <NUM>. End <NUM> is configured for disposal within passageway <NUM>. End <NUM> includes a surface <NUM> configured for connection with a biasing member <NUM>, similar to biasing member <NUM> described herein. Biasing member <NUM> includes a coil spring <NUM> and a follower <NUM>. Follower <NUM> is configured for moveable disposal within sleeve <NUM> and driven or urged in a selected direction under the bias force of spring <NUM> to facilitate translation of rod <NUM>.

Follower <NUM> includes a surface <NUM> that is threaded with a surface <NUM> of sleeve <NUM> to comprise a release member of spinal construct <NUM>. Surface <NUM> is threaded with sleeve <NUM> in a selected configuration, setting and/or position to facilitate delivery of spinal construct <NUM> to a surgical site such as an operating room, back table, medical facility and/or with a patient body. Surface <NUM> is threaded with sleeve <NUM> to connect, attach, fix and/or lock, provisionally, removably and/or permanently, rod <NUM> to sleeve <NUM> in a selected configuration, setting and/or position of spinal construct <NUM>.

For example, spinal construct <NUM> can be disposed in a selected configuration, setting and/or position for delivery of spinal construct <NUM> to a surgical site. Rod <NUM> is contracted, collapsed and/or compressed with biasing member <NUM> within sleeve <NUM> to dispose spinal construct <NUM> in a contracted, collapsed and/or compressed configuration. Surface <NUM> is engaged with sleeve <NUM> in a configuration with rod <NUM> to provisionally fix rod <NUM> in a non-expandable, contracted, collapsed and/or compressed configuration relative to sleeve <NUM> for delivery of spinal construct <NUM> to a surgical site. Spinal construct <NUM> is attached with vertebrae, similar to spinal construct <NUM> described herein. Surface <NUM> is rotated to disengage surfaces <NUM>, <NUM> intra-operatively in a controlled manner to avoid unexpected forces being applied to the vertebrae and allow relative movement of rod <NUM> and sleeve <NUM>. Disengagement of surfaces <NUM>, <NUM> releases spinal construct <NUM> from the selected configuration, setting and/or position to activate and/or release rod <NUM> such that rod <NUM> can dynamically translate and/or expand spinal construct <NUM>, similar to that described.

In an example, as shown in <FIG>, spinal correction system <NUM>, similar to the systems described herein, comprises a spinal construct <NUM>, similar to spinal construct <NUM> described herein. Spinal construct <NUM> includes a body having a sleeve <NUM>, similar to sleeve <NUM> described herein.

Sleeve <NUM> defines a longitudinal axis X9. Sleeve <NUM> extends between an end <NUM> and an end <NUM>. The body of spinal construct <NUM> includes a rod <NUM> extending from end <NUM>. Rod <NUM> extends between an end <NUM> and an end <NUM>. In some embodiments, end <NUM> is monolithically formed with sleeve <NUM>. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, as described herein.

Sleeve <NUM> includes a surface <NUM> that defines a passageway <NUM>, similar to passageway <NUM> described herein. Passageway <NUM> extends axially within sleeve <NUM>. Passageway <NUM> includes an opening <NUM> adjacent end <NUM>. Passageway <NUM> and opening <NUM> are configured for movable disposal of a spinal rod <NUM>, similar to rod <NUM> described herein. Rod <NUM> is configured to translate within passageway <NUM> relative to sleeve <NUM>, as described herein. In some embodiments, rod <NUM> is configured for dynamic axial translation relative to sleeve <NUM>, as described herein. Surface <NUM> defines a cavity <NUM> for disposal of a portion of a lock <NUM>, similar to lock <NUM> described herein.

Rod <NUM> extends between an end <NUM> and an end <NUM>. Rod <NUM> includes a surface <NUM> engageable with an inner surface of lock <NUM> to facilitate translation of rod <NUM> relative to sleeve <NUM> in a first direction and to resist and/or prevent translation of rod <NUM> in a second direction, as described herein. End <NUM> is configured for engagement with tissue and/or a spinal implant, such as, for example, a bone fastener, as described herein. End <NUM> is configured for disposal within passageway <NUM>. End <NUM> includes a surface <NUM> configured for connection with a portion of lock <NUM>, as shown in <FIG>.

A biasing member <NUM>, similar to biasing member <NUM> described herein, includes a spring <NUM> and a follower <NUM>. Follower <NUM> is configured for moveable disposal within sleeve <NUM> and driven or urged in a selected direction under the bias force of spring <NUM> to facilitate translation of rod <NUM>, as described herein. In some embodiments, such translation of rod <NUM> includes expansion of spinal construct <NUM> under the bias force of spring <NUM> to provide a constant pressure to rod <NUM> for growth guidance and distraction.

In some embodiments, follower <NUM> includes a surface <NUM>. Surface <NUM> defines a cavity <NUM> configured for disposal of a portion of lock <NUM>, as described herein. In some embodiments, follower <NUM> includes openings <NUM> configured for disposal of bearings <NUM>. Bearings <NUM> are configured to roll and/or slide between surface <NUM> and a tapered portion <NUM> of lock <NUM> to facilitate translation of rod <NUM> relative to sleeve <NUM>, and/or expansion of the components of spinal construct <NUM>, as described herein.

Spring <NUM> is disposed within sleeve <NUM> and extends between a surface <NUM> of sleeve <NUM> and a surface <NUM> of follower <NUM>. In some embodiments, spring <NUM> extends about an extension <NUM> of follower <NUM>. Spring <NUM> applies a force and/or load to surface <NUM> causing follower <NUM> to drive and/or urge rod <NUM>, as described herein. As such, rod <NUM> is urged to expand spinal construct <NUM> under a constant force of spring <NUM>. In some embodiments, spring <NUM> facilitates dynamic translation of rod <NUM> during growth. Dynamic translation of rod <NUM> allows spinal construct <NUM> to respond to an active and/or changing spine.

For example, as forces and/or force changes are applied to spinal construct <NUM>, such as, for example, patient growth, trauma and degeneration, and/or system <NUM> component creep, deformation, damage and degeneration, one or more components of spinal construct <NUM>, for example, sleeve <NUM>, rod <NUM> and biasing member <NUM> adapt and/or are continuously adjustable with a responsive force to maintain the applied force transmitted from the bone fasteners substantially constant.

Lock <NUM> includes a sleeve <NUM> having an inner surface <NUM> that defines a cavity <NUM>. Rod <NUM> is configured for disposal within cavity <NUM>. In some embodiments, rod <NUM> is connected with sleeve <NUM> and includes bearings <NUM> to facilitate relative rotation of rod <NUM>, as shown in <FIG>. Sleeve <NUM> includes a surface <NUM> that includes an extension <NUM>. Extension <NUM> is configured for disposal with a locking member <NUM>. Member <NUM> includes an extension <NUM> and a receiver <NUM>. Extension <NUM> is configured for disposal with cavity <NUM>. Receiver <NUM> includes tapered portion <NUM> configured for engagement with bearings <NUM>, as described herein. In some embodiments, tapered portion <NUM> may include a constant taper throughout a length. In some embodiments, tapered portion <NUM> extends along a discrete length of receiver <NUM>. In some embodiments, tapered portion <NUM> includes a substantially continuous slope, or may include different slopes along the length.

Lock <NUM> includes a biasing member, such as, for example, a coil spring <NUM>, as shown in <FIG>. Spring <NUM> is disposed within cavity <NUM>. Spring <NUM> applies a force and/or load to a surface <NUM> of member <NUM>. In some embodiments, spring <NUM> stabilizes motion and/or positions lock <NUM> with passageway <NUM>. In some embodiments, spring <NUM> causes lock <NUM> to drive and/or urge rod <NUM>, as described herein. As such, in the non-locked orientation rod <NUM> is urged to expand spinal construct <NUM> under a constant force of springs <NUM>, <NUM>. In some embodiments, springs <NUM>, <NUM> facilitate dynamic translation of rod <NUM> during growth. Dynamic translation of rod <NUM> allows spinal construct <NUM> to respond to an active and/or changing spine.

Upon compression and/or contraction of the components of spinal construct <NUM>, bearings <NUM> slide/roll into a more narrow space between surfaces <NUM> and <NUM> for an interference and/or frictional engagement therewith to compress and/or crimp rod <NUM> with tapered portion <NUM> to resist and/or prevent translation of rod <NUM> relative to sleeve <NUM> and/or compression/contraction of the components of spinal construct <NUM>, as described herein. In some embodiments, translation of rod <NUM> relative to sleeve <NUM> and/or compression/contraction of the components of spinal construct <NUM> is resisted and/or prevented in a locked orientation of spinal construct <NUM>. In some embodiments, lock <NUM> is disengageable or removable from a locked orientation. In some embodiments, lock <NUM> is fixed in a locked orientation.

In some embodiments, spinal construct <NUM> prevents axial migration of rod <NUM> while maintaining a dynamically movable configuration of rod <NUM>. In some embodiments, rod <NUM> may include a dynamically axially translatable configuration, as described herein, and spinal construct <NUM> may be configured, as described herein, such that spinal construct <NUM> may limit, resist and/or prevent movement in at least one direction of rod <NUM> relative to sleeve <NUM>. Movement of bearings <NUM> along tapered portions <NUM> facilitates locking and unlocking of lock <NUM> relative to rod <NUM>.

In some embodiments, member <NUM> includes a surface <NUM> that defines a slot <NUM>. In some embodiments, slot <NUM> is configured for engagement with a pin <NUM> to connect sleeve <NUM> with lock <NUM>. In some embodiments, pin <NUM> and slot <NUM> are configured to guide movement of rod <NUM> and/or lock <NUM>. In some embodiments, pin <NUM> and slot <NUM> define a range of movement of translation of member <NUM>.

Claim 1:
A spinal construct (<NUM>) comprising:
at least two bodies each having
a sleeve (<NUM>; <NUM>; <NUM>) which includes an inner surface (<NUM>) that defines a passageway (<NUM>), and includes a first end (<NUM>; <NUM>; <NUM>) and a second end (<NUM>; <NUM>; <NUM>),
a self-distracting rod (<NUM>; <NUM>) moveably disposed within the passageway (<NUM>) and including a first end (<NUM>; <NUM>) and second end (<NUM>; <NUM>),
a first biasing member (<NUM>; <NUM>) disposed within the sleeve (<NUM>; <NUM>; <NUM>) engaged with the second end (<NUM>; <NUM>) of the rod (<NUM>; <NUM>) for translation of the rod (<NUM>; <NUM>) relative to the sleeve (<NUM>; <NUM>; <NUM>) in a first direction,
a lock (<NUM>; <NUM>) connected with the rod (<NUM>; <NUM>) to resist and/or prevent translation of the rod (<NUM>; <NUM>) relative to the body in a second direction opposite to the first direction to thereby establish a locked orientation of the spinal construct (<NUM>), and
a second biasing member (<NUM>; F, <NUM>) engaged with the lock (<NUM>) to drive the lock (<NUM>) to the locked orientation of the spinal construct (<NUM>),
wherein the sleeves (<NUM>; <NUM>) are disposed in a serial orientation with
the first end (<NUM>) of the rod (<NUM>) of the one sleeve (<NUM>) being configured to be connected with vertebral tissue and/or a spinal implant,
characterized in that
the second end (<NUM>) of the one sleeve (<NUM>) is connected to the first end of the rod (<NUM>) of the other sleeve (<NUM>) so that a translation of the rod (<NUM>) of the other sleeve (<NUM>) in the first direction thereof translates the one sleeve (<NUM>) in the first direction thereof, and
the second end (<NUM>) of the other sleeve (<NUM>) is configured to be connected with vertebral tissue and/or a spinal implant.