Fluid-powered elongation instrumentation for correcting orthopedic deformities

Growing rod systems and methods for correcting spinal deformities include at least one growing rod assembly and at least one fluid delivery assembly. Each growing rod assembly includes a fluid actuator that is operable to extend first and second rod segments in opposite directions along the spine. The fluid actuator can be provided by, for example, a piston-cylinder actuator. Each fluid delivery assembly includes a fluid pump operably connectable to a fluid line, which in turn is connected to the fluid actuator. In one embodiment, the fluid actuator is of a linear design. In another embodiment, two linear or curvilinear fluid actuators are provided back-to-back and connected by a connecting rod that mounts to the mid-spine and is contourable. In another embodiment, the fluid actuator is of a curvilinear design to generally conform the normal spine. And in another embodiment, the fluid actuator includes a fluid-over-fluid shock absorber.

TECHNICAL FIELD

The present invention relates generally to surgical instrumentation and methods for correcting spinal deformities and, more particularly, to spinal growing-rod surgical instrumentation and methods.

BACKGROUND

Scoliosis is a medical condition in which a person's spine is abnormally curved and/or rotated. It is typically classified as congenital (caused by anomalies at birth), neurologic (occurring secondary to central nervous system disorders), or idiopathic (developing over time without definite cause). Idiopathic scoliosis is further sub-classified according to the age at which it occurs, earlier onset being associated with worse prognosis. Treatment of children with progressive scoliosis occurring at a young age is a difficult problem. Left untreated, progressive curves can produce significant deformity leading to deleterious effects on the developing heart and lungs resulting in a shortened lifespan.

Standard treatment for scoliosis includes spinal fusion surgery. This has limited use in younger children because of the potential alteration or cessation of spinal growth, which in turn can have adverse effects on axial growth, chest wall development, and lung development.

There are known methods to treat spinal deformities in the developing child that avoid spinal fusion. These include external bracing and surgery without spinal fusion. However, most early onset scoliosis is rapidly progressive and largely resistant to bracing, and compliance with brace-wearing regimens is generally very poor, which often makes surgical correction the preferred option.

Known non-fusion, growth-preserving surgical procedures include the placement of special spinal instrumentation known as growing rods. Growing rods are devices placed surgically within a patient's back that provide internal bracing in an effort to limit curve progression. An example of a prior art growing rod system10is shown inFIGS. 1-3. The system10includes dual, parallel growing rods12that are secured to vertebrae of a spine14above and below the deformity, thus spanning the curve being addressed. The growing rods12are secured to the spine14at foundation sites16by mounting hardware18(e.g., including mounting clamps, screws, and/or hooks) to form fixation constructs. Typically, two rods12are implanted in a parallel arrangement with one on each lateral side of the spine14. Each rod12is typically composed of two independent rod segments that are longitudinally coupled together using tandem connectors20. This configuration allows the rods12to be longitudinally adjusted (e.g., telescopically) at regular intervals to provide an overall increase in length.

Growing rod placement is an accepted technique that allows correction of deformity without preventing normal axial growth of the spine. This method requires frequent periodic lengthening of the rod system to adjust for longitudinal growth of the spine as the patient matures. Lengthening is performed by loosening the connectors, using a distraction device to push the rod segments apart until the appropriate amount of lengthening has been achieved, and retightening the connectors.

A fundamental strength of this existing growing-rod design over earlier treatments is also a significant weakness. Beneficially, serial lengthening allows the spine to grow. However, it also requires frequent returns to the operating room. Patients treated with this technique typically need repeat surgeries as frequently as every four to six months. This places the child at significantly increased risk for bleeding, infection, wound, and pulmonary complications. Additionally, overnight observation in a hospital is often necessary. Furthermore, young children with severe spinal deformities often have multiple other medical issues resulting in an overall compromised health status, and stress from repeated surgery can be overly burdensome on these patients and their families.

A second issue with current growing rod techniques relates to the timing of the expansion. Growing rods are generally left in place for a period of months before the patient is taken back to the operating room for lengthening. These interval periods allow the tissues surrounding the rods to heal, but also to scar. Scarred tissue within the telescoping connector parts is difficult and time-consuming to dissect, is more prone to infection, and complicates rod expansion. Scar tissue may also serve to further tether the growing spine, thus adding an additional deforming force. In addition, despite periodic lengthening, the interval placement of instrumentation can frequently result in cessation of spinal growth, which ultimately leads to premature fusion of the immature spine.

A third issue with current growing rod techniques relates to the expansion being only linear. When viewed from the side (the sagittal plane), the normal spine is a compound curve consisting of a lumbar curvature that is defined as lordotic or concave with respect to the ventral (front) surface of the body, a thoracic curve that is defined as kyphotic or convex with respect to the ventral surface of the body, and a cervical curve that is lordotic. The degree of curvature defines one's posture and the “sagittal balance,” which is the position of the head over the pelvis when viewed from the side.

All of the known growing-rod devices attempt to control curvature of the spine in a growing child using linear expansion. That is, as the spine elongates, the rods can be extended only linearly. Although the rods themselves can be bent and contoured somewhat (seeFIG. 3), the expansion coupling is linear, so when the growing rod system is expanded the rods are moved only linearly. While this does provide some control of curvature in the coronal plane (front-to-back), this does not account for the natural curvature of the spine in the sagittal plane. Accordingly, when using known linear growing-rod systems, either spinal growth and alignment must be altered from their preferred normal curved state, or the fixation constructs (or another component of the growing-rod system) will fail.

If the rods and fixation constructs are strong enough to avoid failure, the spine will be forced to grow in a linear direction. This results in what is known as hypokyphosis or “acquired flatback deformity” of the thoracic spine. This affects the patient's overall sagittal balance and can result in what is known as negative sagittal balance in which the patient's head is centered posterior to its normal position thus negatively affecting overall posture, which results in chronic thoracic and lumbar pain. Even more potentially problematic for the patient is the possibility of junctional kyphosis. This occurs when the spine abnormally “kinks” at the end of the fixation constructs. With severe sagittal imbalance and hypokyphosis, it is thought that junctional kyphosis is much more likely to occur. This can result in catastrophic neurologic injury to the patient when severe and typically results in revision surgery.

If the fixation constructs are not strong enough or if the bone quality is poor, there is potential for construct failure or pullout from the bony foundation sites due to excessive stress on the system. This typically occurs at the more superior foundation sites on the thoracic spine. In the best case scenario, construct failure results in loss of spinal correction and revision surgery is thus required. In the worst case, the metal screws or hooks can pull out of bone and cause direct injury to the spinal cord resulting in paralysis or theoretically even death, the former having been reported in the medical literature.

Accordingly, it can be seen that a need exists for improved surgical instrumentation and methods for bone-deformity correction. It is to the provision of solutions meeting this need that the present invention is primarily directed.

SUMMARY

Generally described, the present invention relates to devices and methods for correcting and/or maintaining otherwise progressive orthopedic deformities in the spine and/or long bones in humans and/or other animals while also preserving normal anatomic bony growth. In the embodiments described herein, there are provided growing rod systems that include at least one growing rod assembly and at least one fluid delivery assembly. Each growing rod assembly includes a fluid actuator that is operable to extend first and second rod segments in opposite directions along the spine. The fluid actuator can be provided by, for example, a piston-cylinder actuator. Each fluid delivery assembly includes a fluid pump operably connectable to a fluid line, which in turn is connected to the fluid actuator.

In a first example embodiment, the fluid actuator is of a linear piston-cylinder design, with the first rod segment extending longitudinally from the piston and the second rod segment extending longitudinally from the cylinder. In a second example embodiment, first and second piston-cylinder actuators are provided, with the first rod segment extending longitudinally from the first piston, the second rod segment extending longitudinally from the second piston in the opposite direction, and the two cylinders connected by a connecting rod that can be countered and mounted to the mid-spine. In a third example embodiment, the fluid actuator is of a curvilinear design, with the piston and the cylinder having a constant radius of curvature that generally conforms to that of the normal spine. And in a fourth example embodiment, the fluid actuator includes a gas-over-fluid shock absorber that dissipates impacts on the spine and helps to prevent pre-mature or unwanted intervertebral fusion.

The specific techniques and structures employed by the invention to improve over the drawbacks of the prior devices and accomplish the advantages described herein will become apparent from the following detailed description of the example embodiments of the invention and the appended drawings and claims.

DESCRIPTION OF EXAMPLE EMBODIMENTS

Referring to the drawings,FIGS. 4-10show a fluid-powered elongation instrumentation (growing rod) system110according to a first example embodiment. The system110includes at least one growing rod assembly112and at least one fluid supply assembly114. In the depicted embodiment, the system110includes two growing rod assemblies112and two fluid supply assemblies114(seeFIGS. 9 and 10), though one, three, or another number of these could be used in a given application.

The system110uses an actuating fluid (i.e., a liquid or gas), delivered by the fluid supply assemblies114, to expand the growing rod assemblies112. In typical commercial embodiments, the actuating fluid is a hydraulic fluid such as mineral oil, glycerin, silicon oil, or some other biocompatible viscous substance. In alternative embodiments, the actuating fluid is a compressed gas such as nitrogen or compressed air. The actuating fluid does not have to have the same thermal and flow properties of standard hydraulic fluid, as the volume flow rate through the system110is relatively slow such that it is not subject to rapid heating and cooling or to turbulent flow.

Referring toFIGS. 4 and 5, the growing rod assemblies112each include a first rod segment116aand a second rod segment116b(collectively, the “rod segments116”), as well as at least one fluid actuator118configured longitudinally between them. The fluid actuator118is operable to extend the rod segments116in opposite directions (i.e., to extend one of the rod segments relative to the other), thereby providing the desired longitudinal expansion. The fluid actuator118can be provided by, for example, the depicted piston-cylinder actuator. In alternative embodiments, the actuator can be of a non-fluid type such as a ratchet-pawl system, a magnetically indexed system, an electric motor and gearing, a solenoid, or the like. The piston-cylinder actuator118includes a piston120and a cylinder122that reciprocate relative to each other. The cylinder122includes a peripheral cylinder wall124that defines an internal bore126within which the piston120is reciprocatingly received. The piston120telescopes in a linear fashion relative to the internal bore126of the hollow cylinder122. The first rod segment116aextends longitudinally from the piston120and the second rod segment116bextends longitudinally from the cylinder122(or vice versa).

The rod segments116are affixed to the patient's spine130in a conventional fashion using commercially available mounting hardware128. That is, one of the rod segments116is affixed to the spine130at a foundation site selected to be above the deformity and the other one of the rod segments is affixed to the spine at a foundation site selected to be below the deformity. The mounting hardware128can be provided by for example pedicle screws, lamina hooks, pedicle hooks, or other known mounting devices. These known mounting hardware elements have a proven track record of successful instrumentation fixation on the spine.

The first rod segment116aand the piston120can be integrally fabricated together as a single piece or they can be fabricated separately and attached together using conventional manufacturing/assembly techniques. Similarly, the second rod segment116band the cylinder122can be integrally fabricated together as a single piece or they can be fabricated separately and attached together using conventional manufacturing/assembly techniques. For example, the rod segments116and their respective piston-cylinder components120and122can be separately formed and attached together using end-to-end rod connectors available in current spinal-elongation instrumentation sets or using slotted, detent, or threaded connections. In any case, the rod segments116are effectively continuations/extensions of the piston120and the cylinder122.

The rod segments116can be sized and shaped similarly to conventional growing rods. In a typical commercial embodiment, for example, the rod segments116are cylindrical and have diameters of about 4.5 mm to about 6.35 mm. In this way, existing mounting hardware128can be used to mount the rod segments116to the spine130(seeFIGS. 9 and 10). In alternative embodiments, the rod segments can have a rectangular, polygonal, or other regular or irregular cross-sectional shape and/or can have other diameters (or other lateral “thickness” dimensions for non-cylindrical rod segments) selected for providing the desired strength and rigidity. In addition, the rod segments116and the fluid actuator118can have a combined length (in a retracted position and an extended position) that is similar to that of conventional growing rods used in spinal instrumentation.

The rod segments116can be made of a material with a sufficient shear modulus and fatigue strength to permit slight cyclic deflections without failure. In addition, the material selected to make the rod segments116can be sufficiently ductile to permit the rods segments to be plastically deformed into a curve (i.e., contoured) to generally conform to the natural curvature of the spine130and also sufficiently strong to aid in correction of the spinal deformity. Contouring of the rod segments116can be done using currently available rod contouring tools and techniques. Suitable materials for making the rod segments116include, for example, surgical stainless steels, nickel chromium alloys, titanium alloys, or polyetheretherketone (PEEK) or other high-strength thermoplastics. When making the rod segments116of a rigid material with a low ductility that does not readily permit custom contouring the rod segments to the individual patient's spine by the surgical or prep team, the rod segments can be provided in pre-set anatomic contours based for example on the average or ideal spinal curve for young people.

The cylinder120and the piston122can be made of the same material as the rod segments116or they can be made of a different material that is selected for high strength and rigidity and for withstanding the system operating pressure. In a typical commercial embodiment, the growing rod assembly112is designed for withstanding operating pressures of from about 0.0 psi up to about 1,000 psi, with a factor of safety of about at least 5. Suitable materials for making the cylinder wall124and the piston120include, for example, stainless steels, nickel chromium alloys, titanium alloys, or PEEK or other high-strength thermoplastics or other known materials that are used to construct conventional piston-cylinder actuators. Using such a material, the cylinder wall124can have a thickness of for example about 1.0 mm to about 2.0 mm and form the internal bore with a diameter of for example about 6.0 mm to about 8.0 mm, thereby allowing a pushing force of about 195 Newtons to about 340 Newtons at about 1,000 psi. In alternative embodiments, the piston, the cylinder wall, and the cylinder bore can have other diameters or other thicknesses selected for providing the desired strength and rigidity and for withstanding an alternative operating pressure.

The piston-cylinder actuator118includes at least one internal seal132designed to sustain the system operating pressure and prevent leakage of the actuating fluid. In the depicted embodiment, for example, a sleeve seal132(e.g., made of a polymer material) is mounted onto the piston120for engagement with the inner surface of the cylinder wall124(seeFIG. 5). In alternative embodiments, the seal is provided by a series of O-rings (e.g., the two O-rings132aofFIG. 11) or by other conventional sealing elements known in the art.

In addition, the growing rod assembly112can include an anti-rotation mechanism to prevent relative rotational motion between the piston120and the cylinder124. Such rotation can cause binding of the piston120and the cylinder122, damage to the seal132, and damage to other internal mating surfaces of the piston and the cylinder. For example, the anti-rotation mechanism can include mating keyed features of the piston120and the cylinder122to prevent relative rotational motion. In the depicted embodiment, the cylinder122has an end134forming an opening136through which the piston120extends into the cylinder bore126. The piston120includes one or more male splines138(ribs, ridges, posts, pins, etc.) extending outwardly (e.g., radially) from it and the piston-receiving opening136includes one or more female splines140(recesses, notches, channels, etc.) formed in the cylinder end134such that the shape and size of the piston-receiving opening generally correspond to the cross-sectional geometry of the splined piston (seeFIGS. 6 and 7). That is, the female splines140of the piston-receiving opening136receive the male splines138of the piston120to prevent relative rotation between the piston120and the cylinder124, while still permitting easy longitudinal relative motion between them. In an alternative embodiment, the anti-rotation mechanism includes female splines formed in the piston and male splines that extend into the piston-receiving opening and mate with the female splines to prevent relative rotation. And in other alternative embodiments, the anti-rotation mechanism includes other mating keyed elements of the piston and the cylinder such as sections with polygonal or other regular or irregular shapes, longitudinal slots with corresponding guide pins, and the like.

The end134of the cylinder122can be provided by an endcap142that forms the piston-receiving opening136(seeFIG. 6). The endcap142can be held in place by for example conventional fasteners such as set screws144. Also, a guide bushing (not shown), made for example of a polymer, can be mounted at the end134of the cylinder122(e.g., within the cylinder bore126) to contact the piston120and reduce the likelihood of the piston and the cylinder binding.

To prevent the unintentional collapse of the rod segments116in the event of system pressure loss, hysteresis, or fluid leakage, the growing rod assembly112can include an anti-retraction mechanism that incrementally blocks the piston120from retracting into the cylinder bore126. For example, the anti-retraction mechanism can include at least one mechanical catch on the piston120and at least one mechanical catch on the cylinder122that selectively engages the piston catch to prevent collapse of the rod segments116while permitting their expansion. As shown inFIG. 8, the anti-retraction mechanism146of the depicted embodiment includes a series of male catches148that are biased by spring elements150into engagement with a series of female catches152. The male catches148can be provided by one or more ball bearings (e.g., 2.0 mm diameter) that are biased radially inward by helical compression springs150, with the ball bearings and the springs received at least partially within recesses in the inner surface of the cylinder wall124. And the female catches152can be provided by a series of notches in at least one of the male splines138of the piston120, with the notches each including a ramped surface to permit rod segment116expansion and a catch surface to prevent rod segment collapse in the opposite direction. The longitudinal spacing of the ball bearings148and the notches150can be selected such that the block to collapse of the rod segment116occurs in for example about 0.5 mm increments.

In alternative embodiments, the anti-retraction mechanism includes ball bearings biased outwardly from the piston and cooperating notches formed in an inner surface of the cylinder wall, one spring is provided for biasing several of the ball bearings, different male catch elements are provided instead of ball bearings, and/or a linear ratchet-and-pawl mechanism is provided to prevent collapse of the rod segments back into the cylinders.

In another alternative embodiment, the anti-retraction mechanism includes at least one spring element (e.g., a helical compression spring) that is housed in the cylinder and that longitudinally biases the piston to force the rods segments in opposite directions to accomplish rod expansion. The actuating fluid is on the side of the piston opposite from the spring to provide the stop for incremental expansion by selectively being slowly released from the opposite side of the piston from the spring. Thus, in this alternative embodiment, an actuator connector is positioned at the opposite end of the cylinder from in this embodiment. A control assembly is operated to allow the incremental release of the fluid, under the pressure of the spring, through the actuator connector and out of the cylinder to expand the growing rod assembly. And the fluid remaining in the cylinder, instead of being used to expand the growing rod assembly, is used to prevent rod collapse.

In addition, the cylinder118includes a conventional fluid-line connector160through which the pressurized actuating fluid enters the cylinder bore126. The actuator connector160can be provided by a frictional connector, a flared screw-nut connector, or the like. The cylinder118can also include a conventional one-way check valve162located between the actuator connector160and the cylinder bore126to provide pressure relief and to prevent fluid backflow into the fluid supply assembly114.

Having described details of the growing rod assembly112, details of the fluid supply assembly114will now be described with reference toFIGS. 4,9, and10. Each fluid supply assembly14includes at least one fluid line164and at least one fluid delivery device166. Each growing rod assembly112can have a dedicated fluid supply assembly114or they can share one or more fluid supply assemblies.

The exact pressure requirements for rod segment116expansion can vary based on the particular design of the growing rod system110and can be selected based on the force required to correct a particular deformity. Reports in the current literature suggest a force of or less than about 200 Newtons is sufficient to provide for adequate expansion and incremental deformity correction. The growing rod system110of this embodiment can be operated at pressures of less than about 1,000 psi to provide about 350 Newtons of longitudinal expansion force with a nominal cylinder bore126of about 8.0 mm. However, as normal growth occurs and the spine elongates, a low or negative pressure within the cylinder122can result in a condition that will generally require little to no system pressure for expansion.

The fluid lines164supply the actuating fluid that powers the fluid actuators118of the growing rod assemblies112. The fluid lines164are connectable at one end to the actuator connectors and at the opposite end to the fluid delivery device166. The one-way check valve162in the fluid actuator118provides pressure relief and prevents backflow from the actuator into the fluid supply lines164. The fluid lines164are provided by flexible tubing, hosing, or the like, with for example a minimum diameter of about 0.5 mm to about 2.0 mm to handle pressures of about 0.0 psi to about 1,000 psi. The fluid lines164are sterile and made of a biocompatible material so that they can be tunneled under the skin during emplacement of the growing rod assembly112.

In the depicted embodiment, each fluid delivery device166includes an access port assembly168that is connectable to the respective fluid line164and that is operably engagable through the skin by a fluid pump170. The access ports168are sterile and made of a biocompatible material so that they can be emplaced just under the surface of the skin and subcutaneous tissues. Segments of the fluid lines164that are to be placed near the access ports168can be coated with an antibiotic silicone rubber or plastic. A variety of subcutaneous access ports are currently available that can withstand system pressures of up to about 300 psi. As noted above, the design pressure of typical commercial embodiments can be up to about 1,000 psi, which is higher than what known subcutaneous access ports can safely withstand. So depending on the system pressure of a given design, the access ports168may need to be adapted to be capable of withstanding higher pressures. Alternatively, the growing rod system100can be designed to operate at lower pressures so that commercially available access ports can be used.

The fluid pump170of the depicted embodiment is a manually powered, external (to the body), piston-cylinder mechanism that is similar to a conventional syringe. The manual external pump170has an internal bore with a size (e.g., 1.0 mm to about 3.0 mm diameter) to provide actuating pressures (e.g., about 0.0 psi to about 1,000 psi) and volumetric flow (e.g., less than about 0.2 cubic cm) that produce the desired incremental expansion (e.g., about 0.5 mm to about 2.0 mm). The manual external pump170also includes a cannulated needle designed to insert through the skin and mate inside the subcutaneously placed access port168. In embodiments in which the fluid pump170is provided by such a manual syringe-like device, the access ports168can be of a type similar to conventional vascular access ports that are accessed by cannulated large-bore needles. Because the actuation of the fluid pump170is manual, no additional controls are needed. Additional design details of the components of the fluid supply assembly114for delivering pressurized fluid to the fluid actuators118of the growing rod assemblies112will be understood by those of ordinary skill in the art of hydraulics and/or pneumatics.

In an alternative embodiment, the fluid pump is provided by a syringe-like manual external pump having a cannulated needle with threads. The access port has a section with threads that mate with the needle threads to provide a connection that allows delivery of the actuating fluid to the fluid actuator at a pressure adequate for incremental expansion of the rod segments. The access port can be implanted entirely subcutaneously or its threaded section can extend out of the skin. In other alternative embodiments, the fluid pump is provided by other manually actuated, external, conventional or modified hypodermic syringes.

In yet another alternative embodiment, the fluid pump is provided by a non-manually powered external pump (e.g., powered by an electric motor or an air compressor) that delivers actuating fluid from an external fluid reservoir. The electric pump provides fluid pressurization for the fluid actuators and can be provided by a hydraulic or hybrid pneumatic/hydraulic pump. The electric pump supplies pressurized fluid to the actuating cylinders at for example a maximum pressure of about 1000 psi and at a flow volume that causes incremental linear expansion of the rod segments at a rate of about 0.5 mm to about 2.0 mm per month. This may be accomplished with a high-pressure, low-output, positive displacement-type pump powered by DC electric or stepper motors, piezoelectric motors or linear actuators, or externally coupled magnetic drives. In such external electric pump embodiments, an external fluid line extends from the external pump and is removably connectable to the access port. The access port can be implanted with a fluid line connector extending out of the skin, or it can be entirely subcutaneous and accessed for example by a needle connected to the external fluid line. For example, the access port and the external fluid line may include mating connectors to allow delivery of the fluid by the external pump from the fluid reservoir to the fluid actuator at pressures adequate for incremental expansion of the actuator. In addition, in such external electric pump embodiments, the fluid delivery assembly includes a control system that can be a part of or a separate component from the fluid pump. The control system includes a power supply that can be provided by batteries, a power cord for electrically connecting to an electric outlet, a solar cell, etc. The control system also includes an on-off switch and/or other conventional controls for controlling the external fluid pump.

Having described details of the growing rod system110, methods of surgically implanting and using the system will now be described with reference toFIGS. 9 and 10. A single growing-rod assembly112, or dual (or more) growing-rod assemblies, may be used according to surgeon preference and/or as required for the desired correction. For illustration purposes only, the implanting method will be described in connection with dual growing-rod assemblies.

An incision is made above and below the deformity and carried through the subcutaneous tissues, fascia, and paraspinous musculature. Then the posterior elements of the spine are identified. The foundation sites for two growing rods assemblies112are selected using standard open techniques for posterior spinal instrumentation. The rod segments116, which are typically provided in a linear configuration, can be bent into a curved configuration using conventional contouring techniques and tools. For example, the rod segments116can be bent into a curve that generally conforms to the curvature of a normal upper thoracic and lumbar spine. If the fluid lines164are not provided already connected to the fluid actuators118, connection is now made. The two growing rod assemblies112are then placed below the skin and muscle fascia, and then connected to the foundation sites using standard spinal growing rod fixation techniques and mounting hardware128. The growing rod assemblies112can each be mounted only at the ends of the rod segments116above and below the deformity, or they can be additionally mounted at the cylinder to the mid-spine (i.e., at an intermediate location of the deformity, that is, between the top and bottom of the deformity).

The access port168is then installed just beneath the skin and subcutaneous tissues at a suitable site such as the flank. Implanting in the flank of the body is cosmetically acceptable and allows easy access to the port168with minimal risk of local infection. The fluid lines164for powering the fluid actuators118are brought up through the fascia and tunneled under the skin to adjacent the access port168. Then the fluid lines164are connected to the access port168.

Alternatively, the fluid line can be installed exiting out through the skin and plugged, with the unplugged end of the fluid line serving as the access port. However, standard precautions would need to be taken on an ongoing basis to prevent wound complications at the site where the fluid line extends through the skin.

To use the growing rod system110, the fluid pump170is operably coupled to the access port168and actuated to force the actuating fluid through the fluid lines164and into the cylinder bore126. The pressurized fluid forces the piston120to reciprocate, thereby causing the rod segments116to move farther apart, i.e., to expand. For example,FIG. 9shows the rod segments116in a first position mounted to a young patient's spine130with a 50-degree curve. AndFIG. 10shows the same rod segments16expanded to a second position mounted to the same spine130after aging and spinal growth and after the rod segments have been expanded by about 15 percent. In practice, this method is repeated a plurality of times to incrementally expand the rod segments116between the depicted first and second positions.

FIGS. 12-16show a growing rod assembly212of a growing rod system according to a second example embodiment. The growing rod system is similar to that of the first example embodiment in that it includes a growing rod assembly212and a fluid delivery assembly (not shown). In this embodiment, however, the growing rod assembly212includes first and second fluid actuators218aand218bthat are generally aligned to extend first and second rod segments216aand216bin opposite directions along the spine230. In the depicted embodiment, for example, the fluid actuators218aand218bare provided by piston-cylinder actuators that are oriented with their respective pistons220aand220bextendible in opposite directions along the spine230. The first rod segment extends116alongitudinally from the first piston220aand the second rod segment extends116blongitudinally from the second piston220bin an opposite direction.

The fluid actuators218aand218beach have an actuator connector260aand260b, respectively, to which two fluid lines (not shown) are connected. Two access ports (not shown) can be provided for connecting to the fluid lines (and thus to the actuator ports260aand260b) in a one-to-one relationship, thereby providing for independent operation of and variable fluid inflow to the two fluid actuators218. A single fluid pump (not shown) can be used to sequentially and selectively expand the first rod segment216aand/or the second rod segment216b. In alternative embodiments, both fluid lines are split from a single feed line (not shown) that connects to a single access port.

The two cylinders222aand222bof the fluid actuators218aand218bare connected together in an end-to-end arrangement (with the respective pistons220aand220bextendible in opposite directions) by a connector rod272. The connector rod272allows standard spinal mounting hardware228to be used to attach the growing rod assembly212to a foundation site located in the mid-spine (e.g., at the apex of the thoracic curve of the spine). This in turn allows for differential expansion in the lumbar and thoracic regions of the spine230by selectively and differentially expanding the first and/or second rod segments216aor216b. This also provides for more control in correcting rotational deformities in the spine230.

In addition, the connector rod272can be made of a material with sufficient ductility to permit the connector rod to be plastically deformed and contoured into a curve to generally conform to the natural curvature of the spine230and also sufficiently strong to aid in correction of the spinal deformity. Contouring of the connector rod272(as well as of the rod segments216) can be done using currently available rod contouring tools and techniques. Suitable materials for making the connector rod272includes, for example, stainless steels, nickel chromium alloys, titanium alloys, or PEEK or other high-strength thermoplastics. Furthermore, the connector rod272and the cylinders222can be integrally fabricated together as a single piece or these parts can be fabricated separately and attached together using conventional manufacturing techniques.

The methods of installing and using the growing rod system of this embodiment are similar to those of the first embodiment. For this embodiment, however, the installation method includes the step of affixing the connector rod272to the mid-spine using mounting hardware228. And the use method includes the step of selectively operating the fluid delivery assembly214to actuate the first fluid actuator218aand/or the second fluid actuator218bto produce the desired expansion in the lumbar and/or thoracic regions of the spine230.

FIGS. 17-26show a growing rod system310according to a third example embodiment. The growing rod system310is similar to that of the first example embodiment in that it includes two growing rod assemblies312and two fluid delivery assemblies314. Thus, each fluid delivery assembly314includes a fluid pump370connected to a fluid line364, which in turn is connected to an actuator connector360. Also, each growing rod assembly312includes a fluid actuator318that is operable to extend first and second rod segments316aand316b(collectively the “rod segments316”) in opposite directions along the spine330. In the depicted embodiment, for example, the fluid actuator is318is provided by a piston-cylinder actuator with the first rod segment316aextending longitudinally from the piston320and the second rod segment316bextending longitudinally from the cylinder322.

In contrast to the above-described embodiments, however, the fluid actuator318is sagittally curvilinear. Thus, in the depicted embodiment with the piston-cylinder fluid actuator318, the piston320and the cylinder322are both curved in the sagittal plane. In addition, one or both of the rod segments316can be curved in the sagittal plane. The curvature of the fluid actuator318is typically selected to generally conform to the curvature of the normal spine330(i.e., the desired post-treatment curvature). For example, the radius of curvature of the piston320and of the cylinder322is typically in the range of about 20 cm to about 50 cm, and being within the range of about 25 cm to about 35 cm has shown particularly good results. The piston320and the cylinder322have the same constant radius of curvature, and the cylinder has a precise internal bore326to permit the curved piston to reciprocate smoothly within the curved bore. Accordingly, the piston320telescopes in a sagittally curvilinear fashion relative to the internal bore326of the hollow cylinder322. This allows for a curvilinear expansion of the growing rod assembly312that closely (or at least better) approximates the natural curve of the spine330(seeFIG. 26).

The curvilinear piston-cylinder actuator318can be constructed using high-precision manufacturing methods and equipment/tools. For example, the curved piston320and cylinder322can be formed by precision manufacturing techniques such as direct metal laser sintering, centrifugal or vacuum pressure investment-casting, or powder casting, followed by flexible honing and/or electropolishing and electroplating to achieve the desired smoothness of their mating curved surfaces. Testing and experimentation have indicated that, for a piston320and a cylinder bore326each having a constant radius of curvature of about 40 cm, a separation/clearance between the piston outer surface and the cylinder inner surface of about 101.6 microns (0.004 inch) is desired to minimize leakage and binding. Additional testing and experimentation have indicated that, in order to achieve this tight clearance, a surface finish (i.e., smoothness) of no more than about 32 microns (0.001259 inch) is desired for the mating surfaces of the curved piston320and cylinder322. Using the above-mentioned high-precision manufacturing techniques, the curved piston320and cylinder322can be manufactured with an about 8-micron (0.000314-inch) surface finish, which is smooth enough to maintain the piston-cylinder actuator seals during working pressures of up to 3000 psi.

In addition, the fluid actuator318of the depicted embodiment includes a different fluid sealing system. As shown inFIG. 23, the fluid actuator318includes a dual-quad sealing system including a series (e.g., at least two) of main ring seals332a(e.g., X-ring seals) and at least one backing ring seal332b(e.g., an O-ring seal). The ring seals332aand332bcan be made of buna, VITON, silicon or another conventional seal material. The backing O-ring332bis interposed between the two main ring seals332a. In the depicted embodiment, for example, the backing O-ring332bis positioned adjacent the trailing edge of one of the main X-ring seals332aand within the same forward circumferential groove333, while the other one of the main X-ring seals is in the rear circumferential groove.

Furthermore, the fluid actuator318of the depicted embodiment includes a different anti-retraction mechanism. As shown inFIG. 24, the anti-retraction mechanism includes a collet system to prevent rod collapse. The collet system can include at least one wedge374made of a rigid material such as a metal. For example, a single circumferential collar wedge can be provided or a plurality (i.e., two or more) partially-circumferential wedges (with flat or curved bases) can be provided. The wedges374are received in ramped recesses (e.g., notches or circumferential grooves)376in the cylinder wall326. The cylinder322can have an outwardly flared section to accommodate the thickness of the wedges. The wedges374are configured so that they can be positioned within the recesses376and around the piston320in such a way that as the piston moves forward (outward from the cylinder322), the wedges expand diametrically and there is no resultant interference between the piston and wedges, thus permitting easy sliding between them. As the piston320is retracted (back into the cylinder322), however, the wedges374are collapsed diametrically relative to each other (due to the interference between the ramped surfaces of the wedges and the ramped surfaces of the recesses376) resulting in interference between the base surfaces of the wedges and the outer surface of the piston, thus preventing further retraction. A resilient element378such as an O-ring, wave wire, elastic plug or bead, or the like is provided to keep the wedges374as close to the piston320as possible, thus eliminating significant retraction before engagement of the wedges and the piston.

Moreover, the fluid delivery assembly314of the depicted embodiment is different from that of the above-described embodiments. As shown inFIG. 17, for example, the fluid pump370can be provided by an internal (to the body) fluid pump. This may be accomplished with a high-pressure, low-output, positive displacement-type pump powered by DC electric or stepper motors, piezoelectric motors or linear actuators, or externally coupled magnetic drives. Additionally, fluid could be delivered by use of a small volume of highly compressed gas within a small implanted reservoir which could be throttled through a remotely controlled microvalve apparatus. The internal pump370is connected directly to at least one of the growing rod assemblies312by the fluid lines364. The associated valving, power supply, and fluid reservoir can be integral to the pump370. The pump370can be encased in a bio-inert material and surgically implanted in the patient at the time of inserting the growing rod assembly312and the other components of the fluid delivery assembly314. The pump370provides pressurization of the actuating fluid for the fluid actuator318and can be of a hydraulic or hybrid pneumatic/hydraulic design. In a typical commercial embodiment, the pump370supplies pressurized fluid to the fluid actuator318at a pressure of up to about 1000 psi and at a flow volume selected to cause continuous or incremental expansion of the rod segments316at a rate of about 0.5 mm to about 2.0 mm per month. Because the fluid pump is internal (i.e., implanted into the body), a subcutaneous access port is not included in this embodiment.

Additionally, the fluid delivery assembly314of this embodiment includes a control system (not shown) for controlling the actuation of the internal pump370. For example, the control system can include an external remote control unit having a radiofrequency (RF) transmitter, an antenna, a microprocessor controller, control circuitry (for on/off functionality, fluid volume/rate control, low power warning, etc.), and a power supply. The power supply can be provided by one or more batteries, a power cord for electrically connecting to an electric outlet, a solar cell, etc. The control system also includes an internal control unit that the external control unit communicates with and controls. The internal control unit is implanted in the body and is included in or operably connected to the internal pump370. The internal control unit includes an RF receiver, an antenna, a microprocessor controller, control circuitry (for on/off functionality, fluid volume/rate control, etc.), and a power supply. The power supply can be provided by for example one or more batteries. The transmitter, receiver, antennas, microprocessors, and control circuits are of a conventional type for sending and receiving RF signals to remotely controlled electronic devices.

In an alternative embodiment, instead a transmitter and a receiver, the external and internal control units each include a transceiver, thereby also permitting the internal control unit to communicate with the external control unit (e.g., to provide a low-power or low-pressure warning). In such embodiments, the internal control unit can include a pressure sensor for detecting the pressure of the actuating fluid in the fluid actuator, and the external control unit can include an output device for displaying the detected pressure. In other alternative embodiments, the control system includes magnetic controls (e.g., using magnetic signatures) for activating and deactivating the internal electric pump, as is known in the art.

The methods of installing and using the growing rod system310of this embodiment are similar to those of the first embodiment. For this embodiment, however, the use method includes the steps of forming a second incision in area of the body where the internal pump/control unit370is to be implanted. This area can be selected to be cosmetically acceptable and functionally inconspicuous (e.g., over the abdominal or lumbar region). The installation method also includes emplacing the internal pump/control unit370through the second incision and into the selected area, tunneling the fluid lines364below the skin and subcutaneous tissues to adjacent the internal pump/control unit, and connecting the fluid lines to the internal pump/control unit.

FIG. 27shows a portion of a growing rod assembly412of a growing rod system according to a fourth example embodiment. The growing rod system is similar to that of the first example embodiment in that it includes two growing rod assemblies412and two fluid delivery assemblies. Thus, each growing rod assembly412includes a fluid actuator418that is operable to extend first and second rod segments416aand416bin opposite directions along the spine. In the depicted embodiment, for example, the fluid actuator418is provided by a piston-cylinder actuator with the first rod segment extending416alongitudinally from the piston420and the second rod segment extending416blongitudinally from the cylinder422.

In addition, the fluid actuator418includes a fluid-over-fluid shock absorber that allows a slight longitudinal retractive motion of the piston420relative to the cylinder422and thereby dissipates impact forces. This small amount of motion can allow for some motion through the intervertebral disk, which may prevent premature or unwanted intervertebral fusion. In the depicted embodiment, the fluid-over-fluid shock absorber is provided by a floating core plug484and a volume of a compressible gas. The plug484slides within the bore of the cylinder422between the piston420and the cylinder endwall486. The portion of the cylinder bore between the piston420and the plug484at any given position of the piston and the plug defines a first bore sub-space426a. Likewise, the portion of the cylinder bore between the plug484and the cylinder endwall486at any given position of the plug defines a second bore sub-space426b. The compressible gas is held within the first bore sub-space426aand the actuating fluid is delivered under pressure into the second bore sub-space426b. To maintain good sealing, the plug484includes a sealing system432such a dual-quad sealing system (e.g., with a series of X-ring seals432aand at least one backing O-ring seal432b) of the same type as in the third embodiment (seeFIG. 23). The compressible gas can be provided by air, nitrogen, carbon dioxide, or another compressible gas known in the art. In typical commercial embodiments, a relatively small amount of the gas, such as about 0.5 cm3to about 2.0 cm3, is contained in the first bore sub-space426a. In operation, when the patient experiences a generally vertical force on the body (from walking, jumping, falling, etc.), the compressive gas in the first bore sub-space426awill compress slightly, allowing the piston420to retract slightly back into the cylinder422, thereby absorbing some of the force of the impact. In alternative embodiments, the fluid-over-fluid shock absorber is provided in a gas-over-gas, liquid-over-liquid, or liquid-over-gas configuration.

The several example embodiments, and the numerous alternative embodiments thereof, that are described herein include various different assemblies, elements, and features. Each of these various assemblies, elements, and features can be implemented in any other of the herein-described embodiments, unless the context or functional considerations obviously dictate otherwise.

Accordingly, the disclosed growing rod systems provide a number of advantages over the prior art designs. For example, prior art growing rods require frequent operative procedures, are expensive, require excessive resources, and place the patient at unnecessary risk. Certain of the disclosed growing rod systems allow for a single operative procedure for placement followed by periodic rod expansion performed in an office environment with a minimally invasive procedure. This alleviates the need for frequent operations, which would otherwise place the patient at risk of bleeding, infection, pulmonary complications, and frequent anesthetic exposure. In addition, the cost associated with surgical operating room time and overnight observation is eliminated.

Another advantage provided by certain of the disclosed embodiments is that they can be operated to perform slow incremental lengthening (at frequent intervals) and/or continuous lengthening, which is safer and more compatible with preserving normal growth. Additionally, the dual growing rod embodiments can be operated independently and in a coordinated fashion to provide more precise control of spinal deformity corrections. For example, in some instances correction may require expansion on the concave side of the deformity and compression on the convexity to allow straightening. To accomplish this, one of the fluid actuators can be expanded while the other is not, so that the stopped side may catch up before restarting the fluid actuator on that side again.

Yet another advantage provided by certain of the disclosed embodiments relates to the curvilinear design of the fluid actuator. Current systems include a purely linear expansion method, which does not account for the natural curvature of the spine. This in turn leads to hypokyphosis, junctional kyphosis, and increased risk of implant failure or bony pull-out with potential for resultant neurologic injury. Certain of the disclosed embodiments, however, include a curvilinear fluid actuator that provides for rod segment expansion conforming to the natural curvature of the spine.

It is to be understood that this invention is not limited to the specific devices, methods, conditions, or parameters of the example embodiments described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only. Thus, the terminology is intended to be broadly construed and is not intended to be unnecessarily limiting of the claimed invention. For example, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, the term “or” means “and/or,” and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. In addition, any methods described herein are not intended to be limited to the sequence of steps described but can be carried out in other sequences, unless expressly stated otherwise herein.

While the claimed invention has been shown and described in example forms, it will be apparent to those skilled in the art that many modifications, additions, and deletions can be made therein without departing from the spirit and scope of the invention as defined by the following claims.