Hook-spring plate for regulating immature rib growth to correct early-onset scoliosis

Abstract

A device for regulating growth of immature ribs includes a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to an immature rib, and transverse hooks or pedicle screws configured to secure the spring plate to a vertebra.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 407,485, filed September 16, 2022, the entire contents of which are incorporated herein by reference.

[0002] STATEMENT REGARDING FEDERALLY FUNDED RESEARCH none.

[0003] The present invention relates generally to the treatment of early onset scoliosis. In particular, the present invention relates to regulating the growth of immature ribs to correct early onset scoliosis. [Background technology]

[0004] Early-onset scoliosis (EOS, age <10 years) can cause a "rib bump" on the convex side of the curve and force structural deformation of the thorax, which severely restricts thoracic growth during alveolar development and leads to irreversible loss of lung growth and thoracic function. In contrast, adolescent idiopathic scoliosis (AIS, age >10 years), which has a relatively later onset during pulmonary and thoracic development, has less impact on long-term respiratory function. In retrospective studies, untreated EOS was associated with a 300% higher mortality rate due to respiratory failure or cardiovascular disease. This increase was not significant in adults with AIS. The inventors hypothesize that because immature ribs are relatively soft and flexible, and because the thorax of children is significantly more malleable than the rigid thorax of adolescents and adults, progressive EOS affects the structural development of the immature ribs, impeding chest and lung growth in EOS patients. The inventors believe that to allow sufficient space for lung growth in EOS patients, the immature ribs should be widened and adjusted to eliminate the influence of spinal deformity and open the thorax. Summary of the Invention [Means for solving the problem]

[0005] In one embodiment, the present invention comprises a device for regulating growth of immature ribs, the device including a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks, each configured to secure the spring plate to a premature rib, and a transverse hook configured to secure the spring plate to a transverse process of a vertebra. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, each rib hook is configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In another aspect, each transverse hook is configured to be attached to a transverse process of a vertebra by a threaded post, and the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post. In another aspect, each rib hook is configured to be attached to an immature rib and a spring plate is configured to be attached to each rib hook with a fixation screw for each rib hook. In another aspect, the transverse hooks are configured to be attached to the transverse processes of the vertebrae and a spring plate is configured to be attached to the transverse hook with a fixation screw.

[0006] In another embodiment, the present invention comprises a kit for a device for regulating growth of premature ribs, the kit including: a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to a premature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the premature ribs and transverse processes; and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts. In one aspect, the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction.

[0007] In another embodiment, the present invention includes a method for modulating premature rib growth, comprising the steps of: preparing a human patient in need of modulation of premature rib growth; preparing a device for modulating premature rib growth, the device having a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a premature rib, and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; and attaching the device to the premature rib and vertebra. In one aspect, the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In another aspect, each transverse hook is configured to be attached to a transverse process of a vertebra with a threaded post, and a spring plate is configured to be attached to the transverse hook with a locking nut on the threaded post. In another aspect, each rib hook is configured to be attached to an immature rib, and a spring plate is configured to be attached to each rib hook with a fixation screw for each rib hook. In another aspect, the transverse hook is configured to be attached to a transverse process of a vertebra, and a spring plate is configured to be attached to the transverse hook with a fixation screw.

[0008] In another embodiment, the invention comprises a device for regulating growth of premature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length and two rib hooks, each configured to secure the spring plate to a premature rib. In one aspect, each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

[0009] In another embodiment, the present invention comprises a kit for a device for regulating growth of immature ribs, the kit including a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to an immature rib, a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs, and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts.

[0010] In another embodiment, the present invention includes a method of modulating growth of premature ribs, the method comprising the steps of: providing a human patient in need of modulation of growth of premature ribs; providing a device for modulating growth of premature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length and two rib hooks, each configured to secure the spring plate to a premature rib; and attaching the device to the premature rib.

[0011] In another embodiment, the invention comprises a device for regulating growth of immature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a immature rib, and a pedicle screw configured to secure the spring plate to a vertebra. In one aspect, each rib hook is configured to be attached to the immature rib by a screw post, and the spring plate is configured to be attached to each rib hook by a locking nut on each screw post. In another aspect, a pedicle screw has a head configured to engage the spring plate and a locking screw configured to engage the head and secure the spring plate to the head.

[0012] In another embodiment, the present invention comprises a kit for a device for regulating growth of immature ribs, the kit including a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to an immature rib, pedicle screws configured to secure the spring plate to a vertebra, a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs and vertebrae, and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts.

[0013] In another embodiment, the present invention includes a method of modulating growth of immature ribs, the method comprising the steps of: providing a human patient in need of modulation of growth of immature ribs; providing a device for modulating growth of immature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a premature rib, and a pedicle screw configured to secure the spring plate to a vertebra; and attaching the device to the premature rib.

[0014] In another embodiment, the present invention comprises a device for regulating growth of a premature rib, the device including a spring plate configured to provide a resilient spring function that can bend along its length, a medial rib hook positioned proximate a medial end of the spring plate and configured to secure the spring plate to the premature rib, a lateral rib hook positioned proximate a lateral end of the spring plate and configured to secure the spring plate to the premature rib, and a pedicle screw positioned proximate the medial end of the spring plate and configured to secure the spring plate to a vertebra. In one aspect, the spring plate has an angled portion at its lateral end. In another aspect, the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, the inner and outer rib hooks are each configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. [Brief explanation of the drawings]

[0015] For a more complete understanding of the features and advantages of the present invention, reference is now made to the following detailed description of the invention taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 shows a top view of a hook-spring plate system. [Figure 2] FIG. 1 shows a side view of a hook-spring plate system. [Figure 3] FIG. 1 shows a top view of a spring plate. [Figure 4] FIG. 10 shows a side view of the spring plate. [Figure 5] Transverse process hooks are shown. [Figure 6] 13 shows the transverse process hook with the swivel engaged. [Figure 7] Shown are the transverse process hooks with spring plates. [Figure 8] A side view of a rib hook is shown. [Figure 9] 1 shows a rib hook with a post. [Figure 10] Shows rib hooks fixed to spring plates. [Figure 11] FIG. 10 shows a side view of the rib hook, post, spring plate, and nut with a gap to allow for possible linear growth of the rib while implanted. [Figure 12] 10 shows a transverse process swivel used to fix the position and rotation of the spring on the transverse process or rib head. [Figure 13] Detail of the rib fixation post is shown. [Figure 14] 1 shows one embodiment of a top-level device for regulating immature rib growth implanted into the transverse processes of the spine and attached along the length of the ribs. [Figure 15A] ~ [Figure 15B] 10 shows another embodiment of a top-level device for regulating immature rib growth that is implanted into the pedicles of the spine and attached along the length of the ribs. [Figure 16] 10 shows another embodiment of a top-level device for regulating immature rib growth attached along the length of the rib. [Figure 17] A quasi-static bending test is shown in which the rib heads are on top and the pins are placed as close as possible to each other parallel to each other, allowing the bones to rotate about the pin axis in the same way that the rib heads can rotate about their articulation with the transverse processes of the vertebrae. [Figure 18] A dynamic test setup is shown, utilizing the same pin restraint as the quasi-static test, but where the bone is immersed to preserve as much tissue integrity as possible during the relatively long test cycle. [Figure 19] An 8 cm incision is made parallel to and 2 cm lateral to the midline of the spinous processes on the convex (right) side of T8-T10 (apical vertebrae), and the right paraspinal muscles are dissected shallower than the tips of the transverse processes. [Figure 20] Identification of the costovertebral ligaments without damaging the lamina and adjacent spinal facet joint levels is shown. [Figure 21] A custom finder is used to locate the space between the transverse process and the rib head, indicating the landmark for transverse hook insertion, just elevated above the medial border of the costovertebral ligament. [Figure 22] 1 shows the insertion and fixation of the transverse hook using the transverse fixation screw. [Figure 23] 1 shows the insertion and fixation of the medial rib hook using the rib hook fixation screw. [Figure 24] 1 shows the subcutaneous insertion of a flat spring plate from the medial to the lateral incision. [Figure 25] Elevation of the apical rib is shown to restore the normal relationship between the rib head and transverse process based on collapse of the apical rib. [Figure 26] The placement of three spring plates at the apical vertebral level of T8-T10 is shown. [Figure 27] 1 shows x-rays of surgically created scoliosis and placement of a hook-spring plate in a pig. [Figure 28] 1 shows another embodiment of the present invention, a device for regulating immature rib growth. [Figure 29A] 1 shows the spring plate with slots for inserting tulip-head pedicle screws prior to installation. [Figure 29B] 10 shows a wrench used to align a spring plate with a tulip head pedicle screw by turning the wrench. [Figure 30] The operating principle of the device is shown. [Figure 31] 1 shows an image of the patient before implantation of the device. [Figure 32] 1 shows images of control and treated subjects from in vivo animal testing of the device. [Figure 33A] ~ [Figure 33B]10 shows images of treated and control subjects in superior thorax views from in vivo animal testing of the device, respectively. [Figure 34] 1 shows images of control and treated subjects from an in vivo animal study of the device, respectively. [Figure 35A] ~ [Figure 35B] Images of treated subjects immediately after device implantation and two months after implantation are shown, respectively. [Figure 36A] ~ [Figure 36D] Treated subjects are shown before and after device implantation. DETAILED DESCRIPTION OF THE INVENTION

[0016] Illustrative embodiments of the system of the present application are described below. For clarity, not all features of an actual embodiment are described in this specification. It will, of course, be understood that the development of any such actual embodiment will require numerous implementation-specific decisions to achieve the developer's particular goals, including compliance with system- and business-related constraints that will vary from embodiment to embodiment. It will further be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0017] Reference may be made herein to spatial relationships between various components and the spatial orientation of various aspects of components as devices are represented in the accompanying drawings. However, as one of ordinary skill in the art will recognize after fully reading this application, the devices, members, apparatuses, etc. described herein may be placed in any desired orientation. Accordingly, because the devices described herein may be oriented in any desired direction, the use of terms such as "above," "below," "upper," "lower," or other similar terms to describe the spatial relationships between various components or to describe the spatial orientation of aspects of such components should be understood to describe the relative relationships between the components or the spatial orientation of aspects of such components, respectively.

[0018] The present inventors sought to improve the disadvantages of immature ribs by designing a novel rib hook-spring plate implant system for expanding and regulating growth of immature ribs in EOS. The goals were to develop an implant system that: 1) expands immature ribs to prevent and halt rib prominence and scoliotic curve progression; 2) dynamically corrects rib prominence and detorts vertebrae to increase chest volume and correct curves; 3) provides a delaying measure to reduce the progression of spinal and thoracic deformities; and / or 4) can replace casting or bracing or their associated procedures. The inventors believe that this implant system allows ribs to grow normally and allows for safe, minimally invasive insertion and removal. This novel implant system provides a growth-regulating approach to immature ribs for the treatment of early-onset spinal and thoracic deformities.

[0019] 1 and 2 show one embodiment of the present invention, a device 100 for regulating immature rib growth, including a generally flat spring plate 105, a transverse vertebral hook 110, two rib hooks 115a, b, and three fixation post-screws 120a, b, c, along with locking nuts 125a, b, c. Fig. 1 shows a top view, and Fig. 2 shows a side view.

[0020] 3 and 4 show an exemplary spring plate 105, a rectangular flat plate connecting a transverse process hook and two rib hooks (located medially and laterally). FIG. 3 shows a top view, and FIG. 4 shows a side view. The medial end has a rectangular slot and an elongated oval slot, while the lateral end has another elongated oval slot. The plate has a generally flat configuration with increased thickness at the medial end to provide increased bending stiffness near the rib head, where bending loads are highest. The spring plate can be made from, for example, polyetheretherketone (PEEK), titanium, stainless steel, or ultra-high molecular weight polyethylene (UHMWPE) and provides a resilient spring function that allows it to bend along its length. While embodiments of the present invention are discussed herein as having spring plates made from PEEK, PEEK is a non-limiting exemplary material; the spring plate can be made from any biocompatible material that provides suitable resilient spring function that allows it to bend along its length.

[0021] FIG. 5 shows an exemplary transverse hook 110, which is an open C-shaped channel to fit into the transverse process of a vertebra. The rear of the transverse hook 110 has a threaded hole that is initially used for insertion into the transverse process (not shown) using a threaded attachment (not shown). Once the hook 110 is positioned, a drill or awl is used to penetrate the posterior cortex of the transverse process to accept a screw post 120c with an integrated swivel 121 attached, as shown in FIG. 6. The post 120c engages a pre-drilled hole in the transverse process using a trocar tip. A rectangular boss on the swivel 121 engages with a rectangular slot in the spring 105, and a nut 125c is located on the end of the post 120c, securing the spring 105 to the hook 110 and swivel 121, as shown in FIG. 7. When tightened, the nut 125c clamps the swivel 121 in place and prevents further rotation of the swivel 121. The purpose of this is to prevent downward rotation of the ribs, as seen in EOS rib deformity.

[0022] FIG. 8 shows an exemplary rib hook device 115a, which also has an open C-shaped channel. Rib hook device 115b (not shown) is similar to rib hook device 115a. The rear of hook 115a includes a threaded hole extending into the channel. As with transverse hook 110, the threaded hole is first used as an attachment point for an inserter used to position hook 115a against the upper surface of the rib. A hole is then formed in the rib using either an awl or a drill. A screw post 120a is then inserted into the hole and tightened to secure the hook to the rib, as shown in FIG. 9. A nut 125a can then be placed on the exposed end of post 120a, securing spring 105 to the rib, as shown in FIG. 10. This type of hook and spring fixation is utilized both medially and laterally along the length of the rib (not shown).

[0023] 11 shows a side view of rib hook 115a, post 120a, spring plate 105, and nut 125a. Rib post 120a uses a hard stop point that serves two purposes: 1) providing a secure and stable locking point for proper securing of nut 125a and providing backout prevention, and 2) providing clearance between nut 125a and plate 105 that can allow plate 105 to move within the slot along its length. The slot is intended to allow for potential side-to-side rib growth as the patient becomes an adult.

[0024] 12 shows a rectangular swivel 122 that is allowed to pivot about the axis of the threaded portion 120c and is captured and held using a pair of nuts 130a, b on either side of the boss. A locking nut 130b engages the top surface of the swivel 122 and clamps it to the posterior surface of the transverse process hook 110 (not shown). The clamping action is intended to eliminate axial rotation from the swivel 122 and prevent caudal rotation of the rib head. The transverse process hook 110 (not shown) and swivel 122 do not allow the plate to slide along its length relative to the transverse process hook 110 (not shown).

[0025] FIG. 13 shows a rib fixation post 120a with a rounded boss 123 that provides a smooth surface for the spring plate to translate along its length. The lower threaded portion engages with a rib hook 115a (not shown), while the trocar tip is used to drill into the bone. A hexagonal boss 124 provides a hard stop against the rear surface of the rib hook 115a (not shown). The top threaded portion of the post 120a is used to secure a nut 125a (not shown) that secures the plate 105 (not shown). The nut 125a (not shown) tightens against the top surface of the rounded boss 123 to provide a stable nut fixation without clamping directly to the spring plate 105 (not shown), thus allowing the spring plate 105 to slide against the secured hook 115a (not shown).

[0026] 14 shows a top-level device for regulating growth of immature ribs 100 implanted into the transverse processes of the spine 140 and attached along the length of a rib 145. The transverse process hook 110 utilizes a swivel that locks rotation about an axis. Two hooks 115a,b attached to the rib are slotted to allow growth along the length of the rib.

[0027] Alternatively, a pedicle screw construct may be used to attach to the spine, as shown in Figures 15A and 15B. The medial portion of the spring plate 105 may have a male post 150 that fits over the tulip head 155 of the screw, which is then tightened with a locking set screw 160. This provides rotational fixation for the pedicle screw. The pedicle screw head 155 may be fixed, monoaxial, or polyaxial. Alternatively, as shown in Figure 16, only two hooks 115a, b attach to the ribs on the medial and lateral sides.

[0028] Mechanical evaluations were performed on in vitro rib specimens. A series of mechanical tests were performed on separate ribs with and without the plate attached to the rib. A bending load was applied through the rib (from medial to lateral), and the resulting strain and load were measured over a series of five quasi-static load cycles. These tests were performed on full-length ribs, pinned near the rib head while a second parallel pin was placed through the anterior-most cortex of the rib, as shown in Figure 17. A second test was then performed, with the anterior pin placed as close as possible to the lateral rib hook, and the rib retested in the same manner. The second part of this test was specifically to examine the effect that the spring plate would have on the medial portion of the rib, where bending loads were highest and anatomical deformation was most prevalent.

[0029] A total of 28 ribs were tested in full length and showed a mean increase in bending stiffness (N / mm) of 16.64% (standard deviation = 14.07). A total of 25 ribs were tested in the shortened configuration and showed a mean increase in stiffness of 24.24% (standard deviation = 10.62).

[0030] The third part of the mechanical evaluation involved full-length rib testing with the plates in place. The purpose of this testing was to evaluate the cyclic integrity of the attached hardware and the potential impact of the hardware on bone. A small strain-inducing bending load was applied to the rib construct while the rib was immersed in saline. A 2 mm strain was cycled at a rate of 2 Hz to simulate rapid breathing. As shown in Figure 18, after testing one rib to a total of 198 k cycles, a crack was observed midway between the anterior attachment point and the lateral rib hook. A second specimen was tested in the same manner to 254 k cycles, with no hardware or bone damage observed.

[0031] After general anesthesia, the animal was placed in a prone position. As shown in Figure 19, an 8 cm incision was made on the convex (right) side of T8-T10 (apical vertebrae), parallel to and 2 cm lateral to the midline of the spinous processes. The right paraspinal muscles were dissected shallowly below the tip of the transverse process. As shown in Figure 20, the costovertebral ligament was identified without damaging the lamina and the level of the adjacent spinal facet joints. As shown in Figure 21, the landmark for the transverse hook insertion was located just above the medial edge of the costovertebral ligament. A custom finder was used to locate the space between the transverse process and the rib head. The transverse hook was then inserted and secured using a transverse fixation screw, as shown in Figure 22.

[0032] The same incision is used to secure the medial rib hook to the medial portion of the rib. The landmark for medial rib hook insertion is 2 cm lateral from the lateral hook. The rib is exposed subperiosteally. The medial rib hook is inserted and secured using the rib hook fixation screw as shown in Figure 23. For lateral rib hook insertion, an 8 cm lateral skin incision is made parallel and 7 cm lateral to the medial incision. The lateral rib hook is secured using the same technique. The lateral hook and rib hook are secured at three apical levels, T8-T10.

[0033] As shown in Figure 24, a flat spring plate is inserted subcutaneously from the medial to the lateral incision. In the medial portion, the plate is placed submuscularly on the lateral and medial hooks and secured with a rectangular swivel and rib screw post. As shown in Figure 25, based on the collapse of the apical rib, the apical rib is elevated to restore the normal relationship between the rib head and the transverse process. The plate is then locked using a screw-nut. In the lateral portion, the plate is bent downward and locked to the lateral hook using a screw-nut. As shown in Figure 26, three spring plates are placed at the apical vertebral level of T8-T10. After plate placement, the soft tissue is closed in layers. Anteroposterior (AP) and lateral radiographs of the spine are taken intraoperatively in two animals to record the baseline spinal contour.

[0034] As shown in Figure 27, a 47° right thoracic scoliosis was surgically created in a 1-month-old pig (A). One month later, a hook-spring plate was fixed to the three apical levels on the convex side (B). The scoliosis was corrected to 30° immediately after surgery.

[0035] FIG. 28 illustrates another embodiment of the present invention, a device 2800 for regulating immature rib growth. Device 2800 is similar to device 100, except that device 2800 includes a generally flat spring plate 2805 with an angled portion at its outer end. Device 2800 also includes an inner rib hook 2810 located along the body of spring plate 2805 and configured to be secured to spring plate 2805 and the rib by an inner rib fixation screw 2815 and an inner rib locking nut 2820. Device 2800 further includes an outer rib hook 2825 located at the outer end of spring plate 2800 and configured to be secured to spring plate 2805 and the rib by an outer rib fixation screw 2830 and an outer rib locking nut (not shown). At the inner end of spring plate 2805, device 100 includes a polyaxial pedicle screw 2835. A polyaxial pedicle screw 2835 at the medial end of the device 100 is configured to secure the device 2800 to the vertebrae. The illustrated polyaxial pedicle screw 2835 has a tulip head, but other types of heads are also possible. The spring plate 2805 has an increased thickness at the medial end to provide increased bending stiffness near the rib head, where bending loads are highest. The spring plate 2805 can be made from, for example, polyetheretherketone (PEEK), titanium, stainless steel, or ultra-high molecular weight polyethylene (UHMWPE) and provides a resilient spring function that allows bending along its length. While embodiments of the present invention are discussed herein as having spring plates made from PEEK, PEEK is a non-limiting exemplary material; the spring plate can be made from any biocompatible material that provides suitable resilient spring function that allows bending along its length. The inner rib hook 2810 and the outer rib hook 2830 are configured and function like the other rib hooks described herein, for example, rib hooks 115a, 115b.

[0036] One embodiment of the present invention comprises a kit having a device for regulating immature rib growth, e.g., device 2800, and one or more tools for manipulating the medial rib hooks, medial rib fixation screws, medial rib locking nuts, lateral rib hooks, lateral rib fixation screws, lateral rib locking nuts, and pedicle screws provided by device 2800.

[0037] One embodiment of the present invention includes a method of regulating immature rib growth, including the steps of preparing a human patient in need of regulation of immature rib growth, preparing a device for regulating immature rib growth, e.g., device 2800, and attaching the device to the immature rib.

[0038] Figure 29A shows the spring plate with slots for inserting tulip-head pedicle screws before installation, and Figure 29B shows a wrench used to align the spring plate with the tulip-head pedicle screws by turning the wrench.

[0039] Figures 30A and 30B illustrate the principle of operation of device 2800. Figure 30A shows a deformed rib of a patient with EOS when device 2800 is attached to the rib. The arrows indicate the force exerted on the rib by device 2800. Figure 30B shows the rib after the device has acted on it for a period of time.

[0040] Figures 31A and 31B show images of a patient before device 2800 is attached to the patient's ribs. Figure 31A shows an internal image of the patient's spine and ribs and shows the expected effect of device 2800, and Figure 31B shows an external image of the patient and the expected effect of device 2800.

[0041] FIG. 32 shows images of control and treated subjects from an in vivo study of device 2800. The first set of images (starting on the right side of FIG. 32) shows the control and treated subjects in the pre-operative phase of the study. The second set of images shows the control and treated subjects two months after surgery to induce scoliosis in the control and treated subjects. The third image of the treated subject (without a matching control image) shows the treated subject immediately after implantation of device 2800. The fourth, fifth, and sixth sets of images show the control and treated subjects four months after surgery to induce scoliosis and two months after implantation of device 2800 into the treated subject.

[0042] Figures 33A and 33B show superior views of the ribs in a treated subject having device 2800 implanted in the ribs and in a control subject not having device 2800 implanted in the ribs, showing the effect of device 2800 on the ribs.

[0043] Figures 34A-34D show control and treated subjects in a study of device 2800. Figures 34A and 34C show anterior-posterior images of the curved spine and deformed rib cage, respectively, in a control subject without implantation of device 2800. Figures 34B and 34D show anterior-posterior images of the spine and rib cage, respectively, in a treated subject with implantation of device 2800.

[0044] Figures 35A and 35B show images of a treated subject immediately after implantation of the test device and two months after implantation, respectively. Yellow arrows indicate evidence of rib growth.

[0045] Figures 36A-36D show treated subjects before and after implantation of device 2800. Figure 36A shows the treated subject before implantation. Figure 36B shows the treated subject 7 days after implantation. Figure 36C shows the treated subject 19 days after implantation, and Figure 36D shows the treated subject 60 days after implantation of device 2800.

[0046] Spinal and chest wall deformities in children with EOS often compromise respiratory function and postnatal lung growth. Despite significant advances in the understanding and treatment of EOS over the past decade, much research remains to be done to improve current treatment strategies to help maximize respiratory function and enhance quality of life for these patients. This novel hook-spring plate implant system offers the following benefits: 1) a growth-regulating approach for immature ribs to dynamically correct rib deformities and detorsion vertebrae to increase chest volume and correct scoliosis; 2) expansion of immature ribs to prevent and halt rib prominence and scoliotic curve progression; 3) a delaying strategy to reduce the progression of spinal and thoracic deformities; and 4) replacement of casts or braces or their associated procedures. This novel implant system will be particularly useful for difficult EOS patients.

[0047] Any and all aspects of the embodiments of the invention disclosed herein are disclosed as present together in any one embodiment unless hindered by physical impossibility.

[0048] In one embodiment, a device for regulating growth of premature ribs comprises, consists essentially of, or consists of a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a premature rib, and a transverse hook configured to secure the spring plate to a transverse process of a vertebra. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In another aspect, each transverse hook is configured to be attached to a transverse process of a vertebra by a threaded post, and the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post. In another aspect, each rib hook is configured to be attached to an immature rib and a spring plate is configured to be attached to each rib hook with a fixation screw for each rib hook. In another aspect, the transverse hooks are configured to be attached to the transverse processes of the vertebrae and a spring plate is configured to be attached to the transverse hook with a fixation screw.

[0049] In another embodiment, a kit for a device for regulating growth of premature ribs comprises, consists essentially of, or consists of a device for regulating growth of premature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a premature rib, and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the premature ribs and transverse processes; and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction.

[0050] In another embodiment, a method for modulating premature rib growth includes, consists essentially of, or consists of: preparing a human patient in need of modulation of premature rib growth; preparing a device for modulating premature rib growth, the device having a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to a premature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; and attaching the device to the premature rib and vertebra. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In another aspect, each transverse hook is configured to be attached to a transverse process of a vertebra with a threaded post, and the spring plate is configured to be attached to the transverse hook with a locking nut on the threaded post. In another aspect, each rib hook is configured to be attached to an immature rib, and the spring plate is configured to be attached to each rib hook with a fixation screw for each rib hook. In another aspect, the transverse hook is configured to be attached to a transverse process of a vertebra, and the spring plate is configured to be attached to the transverse hook with a fixation screw.

[0051] In another embodiment, a device for regulating growth of premature ribs comprises, consists essentially of, or consists of a spring plate configured to provide a resilient spring function that can bend along its length and two rib hooks, each configured to secure the spring plate to a premature rib. In one aspect, each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

[0052] In another embodiment, a kit for a device for regulating growth of immature ribs comprises, consists essentially of, or consists of a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to an immature rib, a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs, and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts.

[0053] In another embodiment, a method for modulating growth of premature ribs includes, consists essentially of, or consists of the steps of: preparing a human patient in need of modulation of growth of premature ribs; preparing a device for modulating growth of premature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length and two rib hooks, each configured to secure the spring plate to a premature rib; and attaching the device to the premature rib.

[0054] In another embodiment, a device for regulating growth of immature ribs comprises, consists essentially of, or consists of a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a immature rib, and a pedicle screw configured to secure the spring plate to a vertebra. In one aspect, each rib hook is configured to be attached to the immature rib by a screw post, and the spring plate is configured to be attached to each rib hook by a locking nut on each screw post. In another aspect, the pedicle screw has a head configured to engage the spring plate and a locking screw configured to engage the head and secure the spring plate to the head.

[0055] In another embodiment, a kit for a device for regulating growth of immature ribs comprises, consists essentially of, or consists of a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to an immature rib, pedicle screws configured to secure the spring plate to a vertebra, a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs and vertebrae, and one or more tools for manipulating the plurality of fixation screws or a plurality of screw posts and locking nuts.

[0056] In another embodiment, a method for modulating growth of immature ribs includes, consists essentially of, or consists of the steps of: preparing a human patient in need of modulation of growth of immature ribs; preparing a device for modulating growth of immature ribs, the device having a spring plate configured to provide a resilient spring function that can bend along its length, two rib hooks each configured to secure the spring plate to a premature rib, and a pedicle screw configured to secure the spring plate to a vertebra; and attaching the device to the premature rib.

[0057] In another embodiment, a device for regulating growth of premature ribs comprises, consists essentially of, or consists of: a spring plate configured to provide a resilient spring function that can bend along its length; a medial rib hook disposed proximate a medial end of the spring plate and configured to secure the spring plate to a premature rib; a lateral rib hook disposed proximate a lateral end of the spring plate and configured to secure the spring plate to a premature rib; and a pedicle screw disposed proximate a medial end of the spring plate and configured to secure the spring plate to a vertebra. In one aspect, the spring plate has an angled portion at its lateral end. In another aspect, the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In another aspect, the spring plate has an increased thickness at its medial end. In another aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In another aspect, the inner rib hook and the outer rib hook are each configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

[0058] It should be understood that the specific embodiments described herein are shown by way of illustration and not as limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific procedures described herein. Such equivalents are considered to be within the scope of this invention and are covered by the claims.

[0059] All publications and patent applications mentioned in this specification are indicative of the level of skill of those skilled in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0060] The use of the word "a" or "an" when used in conjunction with the term "comprising" in the claims and / or this specification can mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more than one." The use of the term "or" in the claims is used to mean "and / or" unless expressly indicated to refer to alternatives only or unless the alternatives are mutually exclusive, although this disclosure supports a definition that refers to "and / or" only. Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of error for the device, method employed to determine the value, or the variation that exists in the research subject.

[0061] As used in the specification and claims, the words "comprising" (and any form of "comprising," such as "comprise" and "comprises"), "having" (and any form of "having," such as "have" and "has"), "including" (and any form of "including," such as "includes" and "include"), or "containing" (and any form of "containing," such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. In any embodiment of the compositions and methods provided herein, "consisting essentially of" or "consisting of" may be used in place of "comprising." As used herein, the phrase "consisting essentially of" requires specified integers or steps and integers or steps that do not materially affect the characteristics or functionality of the claimed invention. As used herein, the term "consisting" is used to indicate the presence of only the enumerated integers (e.g., features, elements, attributes, properties, method / process steps, or limitations) or group of integers (e.g., features, elements, attributes, properties, method / process steps, or limitations).

[0062] As used herein, the term "or combinations thereof" refers to all permutations and combinations of the items listed before this term. For example, "A, B, C, or combinations thereof" is intended to include at least one of A, B, C, AB, AC, BC, or ABC, and, where order is important in the particular context, BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing this example, combinations containing one or more repeats of an item or term are expressly included, for example, BB, AAA, AB, BBC, AAABCCCC, CBBAAA, and CABABB. Those of skill in the art will understand that there is typically no limit to the number of items or terms in any combination unless the context clearly indicates otherwise.

[0063] As used herein, without limitation, approximating terms such as "about," "substantial," or "substantially" refer to a condition that, when so modified, is understood to be not necessarily absolute or complete, but that would be considered by one of ordinary skill in the art to be close enough to warrant specifying the condition as existing. The degree to which a description may vary depends on how large a change can occur and still allow one of ordinary skill in the art to recognize the modified feature as still possessing the desired properties and capabilities of the unmodified feature. Generally, but subject to the preceding discussion, numerical values ​​herein modified by approximating terms such as "about" may vary by at least ±1, 2, 3, 4, 5, 6, 7, 10, 12, or 15% from the stated value.

[0064] All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices and / or methods of the present invention have been described with reference to specific embodiments, it will be apparent to those skilled in the art that variations can be applied to the compositions and / or methods, and in the steps or sequence of steps of the methods, described herein without departing from the concept, spirit, and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the invention as defined by the appended claims.

[0065] Furthermore, no limitations are intended to the details of construction or design herein shown, other than as described in the claims below. Therefore, the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the present disclosure. Accordingly, the protection sought herein is set forth in the following claims.

[0066] Modifications, additions, or omissions may be made to the systems and devices described herein without departing from the scope of the invention. System and device components may be integrated or separated. Furthermore, system and device operations may be performed by more, fewer, or other components. Methods may include more, fewer, or other steps. Furthermore, steps may be performed in any suitable order.

[0067] To assist the Patent Office, and any reader of any patent that may issue on this application, in interpreting the claims appended hereto, Applicants wish to point out that they do not intend to invoke 35 U.S.C. § 112(f) as it exists on the filing date of this application for any of the appended claims, unless the words "means for" or "step for" are expressly used in a particular claim.

[0068] [References] 1.Bottlang M, Walleser S, Noll M, et al. Biomechanical Rationale and Evaluation of an Implant System for Rib Fracture Fixation. Eur J Trauma Emerg Surg 2010; 36: 417-426. 2.Szopa A and Domagalska-Szopa M. Correlation Between Respiratory Function and Spine and Thorax Deformity in Children with Mild Scoliosis. Medicine 2017; 96:22. 3.Redding GJ and Mayer OH. Structure-Respiration Function Relationships Before and After Surgical Treatment of Early-onset Scoliosis. Clin Orthop Relat Res 2011; 469: 1330-1334. 4.Olson JC, Takahashi A, Glotzbecker MP, et al. Extent of Spine Deformity Predicts Lung Growth and Function in Rabbit Model of Early Onset Scoliosis. PLOS ONE 2015; 1-16. 5.Beauchamp EC, Anderson RCE, and Vitale MG. Modern Surgical Management of Early Onset and Adolescent Idiopathic Scoliosis. Neurosurgery 2019; 84 (2): 291-304. 6.Wang XB, Zhang H, and Sucato DJ. Unilateral Thoracic Nerve Neurotomy Causes Rib Cage Torsion and Idiopathic-like Thoracic Scoliosis. Spine Deformity 2014: 2 (6): 508. 7.Zhang H and Sucato DJ. Unilateral Pedicle Screw Epiphyseodesis of the Neurocentral Synchondrosis Produces Idiopathic-Like Scoliosis in an Immature Animal Model. J Bone Joint Surg Am. 2008; 90: 2460-9. 8.Zhang H and Sucato DJ. Neurocentral Synchondrosis Screws to Create and Correct Experimental Deformity. Clin Orthop Relat Res 2011: 469:1383-1390. 9.Zhou X, Zhang H, Sucato DJ, and Johnston CE. Effect of Dual Screw Across the Vertebral Neurocentral Synchondrosis on Spinal Canal Development in an Immature Spine. J Bone Joint Surg Am. 2014; 96 (17): e146(1-7).

Claims

1. 1. A device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a transverse hook configured to secure the spring plate to a transverse process of a vertebra; A device comprising:

2. The device of claim 1 , wherein the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene.

3. The device of claim 1 , wherein the spring plate has an increased thickness at an inner end.

4. The device of claim 1 , wherein the spring plate is biased to provide a force in a cranial or caudal direction.

5. 10. The device of claim 1, wherein each rib hook is configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

6. 10. The device of claim 1, wherein each transverse hook is configured to be attached to a transverse process of the vertebra by a threaded post, and the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post.

7. 2. The device of claim 1, wherein each rib hook is configured to be attached to the immature rib, and the spring plate is configured to be attached to each rib hook by a set screw for each rib hook.

8. The device of claim 1 , wherein the transverse hook is configured to be attached to a transverse process of the vertebra, and the spring plate is configured to be attached to the transverse hook by a fixation screw.

9. 1. A kit for a device for regulating immature rib growth, comprising: a device for regulating the growth of the immature ribs, a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a transverse hook configured to secure the spring plate to a transverse process of a vertebra; the device, a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs and the transverse processes; one or more tools for manipulating the plurality of set screws or the plurality of threaded posts and lock nuts; A kit comprising:

10. 10. The kit of claim 9, wherein the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene.

11. 10. The kit of claim 9, wherein the spring plate has an increased thickness at an inner end.

12. 10. The kit of claim 9, wherein the spring plate is biased to provide a force in a cranial or caudal direction.

13. 1. A method for modulating premature rib growth, comprising: providing a human patient in need of regulation of immature rib growth; providing a device for regulating growth of the immature ribs; the device comprising: a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a transverse hook configured to secure the spring plate to a transverse process of a vertebra; attaching the device to the immature ribs and the vertebrae; A method comprising:

14. The method of claim 13 , wherein the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene.

15. The method of claim 13 wherein the spring plate has an increased thickness at an inner end.

16. 14. The method of claim 13, wherein the spring plate is biased to provide a force in a cranial or caudal direction.

17. 14. The method of claim 13, wherein each rib hook is configured to be attached to the premature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

18. 14. The method of claim 13, wherein each transverse hook is configured to be attached to a transverse process of the vertebra by a threaded post, and the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post.

19. 14. The method of claim 13, wherein each rib hook is configured to be attached to the immature rib, and the spring plate is configured to be attached to each rib hook by a set screw for each rib hook.

20. 14. The method of claim 13, wherein the transverse hook is configured to be attached to a transverse process of the vertebra, and the spring plate is configured to be attached to the transverse hook by a fixation screw.

21. 1. A device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to the immature rib; A device comprising:

22. 22. The device of claim 21, wherein each rib hook is configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

23. 1. A kit for a device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function that can bend along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a plurality of fixation screws or a plurality of threaded posts and locking nuts for attaching the device to the immature ribs; one or more tools for manipulating the plurality of set screws or the plurality of threaded posts and lock nuts; A kit comprising:

24. 1. A method for modulating premature rib growth, comprising: providing a human patient in need of regulation of immature rib growth; providing a device for regulating growth of the immature ribs; the device comprising: a spring plate configured to provide a resilient spring function in bending along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and attaching the device to the immature rib; A method comprising:

25. 1. A device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function in bending along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a pedicle screw configured to secure the spring plate to a vertebra; A device comprising:

26. 26. The device of claim 25, wherein each rib hook is configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

27. 26. The device of claim 25, wherein the pedicle screw comprises a head configured to engage the spring plate and a locking screw configured to engage the head to secure the spring plate to the head.

28. 1. A kit for a device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function in bending along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a pedicle screw configured to secure the spring plate to a vertebra; a plurality of fixation screws or a plurality of screw posts and locking nuts for attaching the device to the immature ribs and the vertebrae; one or more tools for manipulating the plurality of set screws or the plurality of threaded posts and lock nuts; A kit comprising:

29. 1. A method for modulating premature rib growth, comprising: providing a human patient in need of regulation of immature rib growth; providing a device for regulating growth of the immature ribs; the device comprising: a spring plate configured to provide a resilient spring function in bending along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a pedicle screw configured to secure the spring plate to a vertebra; and attaching the device to the immature rib; A method comprising:

30. 1. A device for regulating immature rib growth, comprising: a spring plate configured to provide a resilient spring function in bending along its length; an inner rib hook disposed proximate an inner end of the spring plate and configured to secure the spring plate to the immature rib; an outer rib hook disposed proximate an outer end of the spring plate and configured to secure the spring plate to the immature rib; a pedicle screw disposed at the medial end of the spring plate and configured to secure the spring plate to a vertebra; A device comprising:

31. 31. The device of claim 30, wherein the spring plate has an angled portion at the outer end of the spring plate.

32. 31. The device of claim 30, wherein the spring plate is made from polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene.

33. 31. The device of claim 30, wherein the spring plate has an increased thickness at the inner end.

34. 31. The device of claim 30, wherein the spring plate is biased to provide a force in a cranial or caudal direction.

35. 31. The device of claim 30, wherein the inner rib hook and the outer rib hook are each configured to be attached to the immature rib by a threaded post, and the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

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