Hook-spring plate structure for growth regulation of immature ribs to correct premature scoliosis

Abstract

A device for adjusting the growth of immature ribs, comprising: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks each configured to secure the spring plate to an immature rib; and a lateral hook or pedicle screw configured to secure the spring plate to the lateral process of the vertebra.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 407,485, filed on September 16, 2022, the entire contents of which are incorporated by reference into this application. Statement on Federally Sponsored Research

[0002] none. Technical Field

[0003] The present application generally relates to the treatment of early-onset scoliosis. In particular, the present application relates to the growth regulation of immature ribs to correct early-onset scoliosis. Background Art

[0004] Early-onset scoliosis (EOS, age <10 years) can cause a "rib hump" on the convex side of the curve and cause structural deformities of the chest cavity, which severely restrict chest growth during the alveolar development stage and lead to irreversible loss of lung growth and chest function. In contrast, adolescent idiopathic scoliosis (AIS, age >10 years) develops relatively late in the growth of the lungs and chest and has less impact on long-term respiratory function. In a retrospective study, untreated EOS was associated with a 300% higher mortality rate from respiratory failure or cardiovascular disease than normal. This increase was not significant in adults with AIS. The inventors speculate that progressive EOS affects the structural development of the immature ribs of EOS patients and inhibits the growth of their chest and lungs, because the immature ribs are relatively soft and flexible, while the rib cage of infants is significantly plastic compared to the rigid ribs of adolescents and adults. The inventors believe that the immature ribs should be strengthened and adjusted to offset the effects of spinal deformity and open the chest cavity to provide sufficient space for lung growth in EOS patients. Summary of the invention

[0005] In one embodiment, the present application provides a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to fix the spring plate to an immature rib; and a transverse hook configured to fix 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 one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial direction or a caudal direction. In one aspect, each rib hook is configured to be attached to an immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In one aspect, each transverse hook is configured to be attached to a transverse process of a vertebra by a threaded post, and wherein the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post. In one 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 by a fixing screw on each rib hook. In one 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 via a set screw.

[0006] In one embodiment, the present application provides a kit for a device for regulating the growth of an immature rib, comprising: the device for regulating the growth of an immature rib comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to fix the spring plate to an immature rib; and a transverse hook configured to fix the spring plate to a transverse process of a vertebra; a plurality of fixing screws or a plurality of threaded posts and locking nuts for attaching the device to the immature rib and the transverse process; and one or more tools for operating the plurality of fixing screws or the plurality of threaded posts and locking nuts. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, wherein the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide force in a cranial direction or a caudal direction.

[0007] In one embodiment, the present application provides a method for regulating the growth of an immature rib, comprising: providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to fix the spring plate to the immature rib; and a transverse hook configured to fix the spring plate to the transverse process of a vertebra; and attaching the device to the immature rib and the vertebra. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial direction or a caudal direction. In one aspect, each rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In one aspect, each transverse hook is configured to attach to a transverse process of a vertebra via a threaded post, and wherein the spring plate is configured to attach to the transverse hook via a locking nut on the threaded post. In one aspect, each rib hook is configured to attach to an immature rib, and the spring plate is configured to attach to each rib hook via a set screw on each rib hook. In one aspect, the transverse hook is configured to attach to a transverse process of a vertebra, and the spring plate is configured to attach to the transverse hook via a set screw.

[0008] In one embodiment, the present application provides a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; and two rib hooks, each configured to secure the spring plate to the immature rib. In one aspect, each rib hook is configured to be attached to the immature rib via a threaded post, and wherein the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post.

[0009] In one embodiment, the present application provides a kit of a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a plurality of fixing screws or a plurality of threaded posts and locking nuts for attaching the device to the immature rib; and one or more tools for operating the plurality of fixing screws or the plurality of threaded posts and locking nuts.

[0010] In one embodiment, the present application provides a method for regulating the growth of an immature rib, comprising: providing a human patient who needs to regulate the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide an elastic spring function when bent along its length; and two rib hooks, each configured to fix the spring plate to the immature rib; and attaching the device to the immature rib.

[0011] In one embodiment, the present application provides a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a pedicle screw configured to secure the spring plate to the vertebra. In one aspect, each rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In one aspect, 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.

[0012] In one embodiment, the present application provides a kit of a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to an immature rib; a pedicle screw configured to secure the spring plate to a vertebra; a plurality of fixation screws or a plurality of threaded posts and locking nuts for attaching the device to the immature ribs and vertebrae; and one or more tools for operating the plurality of fixation screws or the plurality of threaded posts and locking nuts.

[0013] In one embodiment, the present application provides a method for regulating the growth of an immature rib, comprising: providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a pedicle screw configured to secure the spring plate to a vertebra; and attaching the device to the immature rib.

[0014] In one embodiment, the present application provides a device for regulating the growth of an immature rib, comprising: a spring plate configured to provide an elastic spring function when bent along its length; a medial rib hook disposed near the medial end of the spring plate and configured to fix the spring plate to the immature rib; a lateral rib hook disposed near the lateral end of the spring plate and configured to fix the spring plate to the immature rib; and a pedicle screw disposed at the medial end of the spring plate and configured to fix the spring plate to the vertebra. In one aspect, the spring plate includes an inclined portion at its lateral end. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial direction or a caudal direction. In one aspect, each of the medial rib hook and the lateral rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] For a more complete understanding of the features and advantages of the present application, reference is now made to the detailed description of the present application and to the accompanying drawings, in which:

[0016] Figure 1 is a top view of the hook-spring plate system.

[0017] Figure 2 is a side view of a hook-spring plate system.

[0018] Figure 3 is a top view of the spring plate.

[0019] Figure 4 is a side view of the spring plate.

[0020] Figure 5 The hook of the transverse process is shown.

[0021] Figure 6 The transverse process hook is shown in rotational engagement.

[0022] Figure 7 The transverse process hook with spring plate is shown.

[0023] Figure 8 Shown is a side view of the hook-spring plate system.

[0024] Fig. 9 A rib hook with a post is shown.

[0025] Fig.10 The rib hooks are shown fixed to the spring plate.

[0026] Fig.11 is a side view of the rib hook, post, spring plate, and nut, with the gap providing linear growth potential for the rib when implanted.

[0027] Fig.12 A transverse process swivel is shown for securing the position and rotation of the spring on the transverse process or rib head.

[0028] Fig.13 Details of the rib fixation posts are shown.

[0029] Fig.14 An embodiment of a top layer device for regulating the growth of an immature rib implanted into the transverse process of the spine and attached along the length of the rib is shown.

[0030] Fig.15A and 15B Another embodiment of a top device for regulating the growth of an immature rib implanted on the pedicles of the spine and attached along the length of the rib is shown.

[0031] Fig.16Another embodiment of a top layer device for regulating the growth of an immature rib that is attached along the length of the rib is shown.

[0032] Fig.17 A quasi-static bending test is shown with the rib head at the top and the pins as close to parallel to each other as possible, where the pins allow the bone to rotate along the pin axis, similar to the way the rib head is able to articulate along the transverse processes of the spine.

[0033] Fig.18 A dynamic test setup is shown, which utilizes the same steel pin restraint as the quasi-static test, but the bone is submerged during a relatively long test period to maintain tissue integrity as much as possible.

[0034] Fig.19 An 8 cm incision is shown parallel to the midline and 2 cm lateral to the spinous process on the convex side (right side) of T8 to 10 (apex), where the right paraspinal muscle will be dissected superficial to the tip of the transverse process.

[0035] Fig. 20 Identification of the costovertebral ligaments without damaging the lamina and adjacent facet joints is shown.

[0036] Fig.21 The marked point for the transverse hook insertion just above the medial edge of the costovertebral ligament is shown, with a custom-made finder used to find the space between the transverse process and the costal head.

[0037] Fig. 22 Insertion of the transverse hook and fixation of the transverse hook using a transverse fixation screw are shown.

[0038] Fig.23 Insertion and fixation of the medial rib hook using a rib hook fixation screw is shown.

[0039] Fig.24 A flat spring plate is shown inserted subcutaneously through the medial incision into the lateral incision.

[0040] Fig.25 Apical rib elevation based on apical rib collapse is shown to restore the normal relationship between the rib head and transverse process.

[0041] Fig.26 There are three spring plates placed horizontally at the top of T8 to T10.

[0042] Fig. 27 Shown is an x-ray of a surgically induced scoliosis in a pig and placement of a hook-spring plate.

[0043] Fig.28 A device for regulating the growth of immature ribs according to another embodiment of the present invention is shown.

[0044] Fig.29A A spring plate is shown with a slot into which a flared head pedicle screw is inserted prior to installation. Fig.29B A wrench is shown which is used to align a spring plate using a flared head pedicle screw by turning the wrench.

[0045] Fig. 30A and 30B The working principle of the device.

[0046] Fig.31A and 31B An image of a patient before implantation of the device is shown.

[0047] Fig.32 Images of control and treated subjects from in vivo animal trials of the device are shown separately.

[0048] Fig.33A and 33B The top view images of the chest cavity of the treated subjects and the control subjects in the in vivo animal test of the device are shown respectively.

[0049] Figures 34A-34D Images of control and treated subjects from in vivo animal trials of the device are shown separately.

[0050] Fig.35A and 35B Images of the treated subject are shown immediately after implantation and two months after implantation of the device.

[0051] Figures 36A-36D Shown is a treated subject before and after implantation of the device. DETAILED DESCRIPTION

[0052] Illustrative embodiments of the system of the present application are described below. For the sake of clarity, not all features of the actual implementation are described in this specification. Of course, it should be understood that many implementation-specific decisions must be made in the development of any such actual implementation to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from implementation to implementation. In addition, it should be understood that such development work may be complex and time-consuming, but it is still routine work for those of ordinary skill in the art who benefit from the present disclosure.

[0053] In this specification, as the various devices are shown in the accompanying drawings, reference may be made to the spatial relationship between multiple components and the spatial orientation of multiple aspects of the components. However, as will be appreciated by those skilled in the art after reading this application in its entirety, the devices, components, equipment, etc. described herein may be positioned in any desired orientation. Therefore, the use of terms such as "above", "below", "upper", "lower" or other similar terms to describe the spatial relationship between various components or to describe the spatial orientation of multiple aspects of these components should be understood to describe the relative relationship between such components or the spatial orientation of multiple aspects of these components, respectively, because the devices described herein may be positioned in any desired orientation.

[0054] The inventors sought to remedy the shortcomings of immature ribs by designing a novel rib hook-spring plate implant system for augmentation and growth regulation of immature ribs in EOS. The goal was to develop an implant system that could: 1) augment immature ribs to prevent and arrest rib hump and scoliosis progression; 2) regulate growth deformities of immature ribs to dynamically correct rib hump and correct rotational deformities of the vertebrae to increase thoracic volume and correct curves; 3) provide a delay strategy to reduce the progression of spinothoracic deformities; and / or 4) replace casts or struts or work in conjunction with these treatments. The inventors expect that the implant system will allow for normal growth of the ribs and allow for safe, minimally invasive insertion and removal. This new implant system will provide a growth regulation method for immature ribs for the treatment of early-onset spinal and thoracic deformities.

[0055] Figure 1 and 2 A device 100 for regulating the growth of immature ribs according to an embodiment of the present invention is shown, which includes a substantially flat spring plate 105, a vertebral transverse hook 110, two rib hooks 115a, 115b and three fixing nut screws 120a, 120b, 120c with locking nuts 125a, 125b, 125c. Figure 1 is a top view, Figure 2 It is a side view.

[0056] Figure 3 and 4 An exemplary spring plate 105 is shown, which is a rectangular flat plate connecting the transverse process hook and two rib hooks (medially and laterally placed). Figure 3 is a top view, Figure 4is a side view. The medial end has a rectangular groove and an elongated oval groove, and the lateral end has another elongated oval groove. The plate is a large flat configuration, and its thickness increases at the medial end to provide increased bending stiffness near the rib head where the bending load is highest. The spring plate can be made of materials such as polyetheretherketone (PEEK), titanium, stainless steel, or ultra-high molecular weight polyethylene (UHMWPE) and provide an elastic spring function when bent along its length. Although the present application embodiments are discussed herein including spring plates made of PEEK, PEEK is a non-limiting exemplary material, and the spring plate can be made of any biocompatible material that provides an appropriate elastic spring function when bent along its length.

[0057] Figure 5 An exemplary transverse hook 110 is shown which is an open C-channel to accommodate the transverse process of a vertebra. The rear portion of the transverse hook 110 has a threaded hole which is first used to insert into the transverse process (not shown) using an installation tool (not shown) threaded therein. Once the hook 110 is placed, a drill or awl is used to pierce the posterior cortex of the transverse process in order to receive a threaded post 120c with an integrated rotator 121 attached, such as Figure 6 The post 120c is engaged with the pre-drilled hole in the transverse process using the trocar tip. The rectangular boss on the rotator 121 engages with the rectangular slot of the spring 105, and a nut 125c is placed on one end of the post 120c that secures the spring 105 to the hook 110 and the rotator 121, as shown. Figure 7 Nut 125c secures the rotator 121 in place and prevents further rotation of the rotator 121 when tightened. This is to counteract the downward rotation of the ribs seen during EOS rib deformation.

[0058] Figure 8 An exemplary rib hook device 115a is shown, which is also an open C-channel. Rib hook device 115b (not shown) is similar to rib hook device 115a. The rear portion of hook 115a includes a threaded hole extending into the channel. Similar to transverse hook 110, the threaded hole is first used as an attachment point for an inserter that is used to place hook 115a over the rib. An awl or drill is then used to drill a hole in the rib. The threaded post 120a is then inserted into the hole and tightened, thereby securing the hook to the rib, as shown in FIG. Fig. 9 Nut 125a can then be placed on the exposed end of post 120a securing spring 105 to the rib, as shown. Fig.10 This type of hook and spring fastener is used along the length of the rib, both medially and laterally (not shown).

[0059] Fig.11A side view of the rib hook 115a, post 120a, spring plate 105 and nut 125a is shown. The rib post 120a uses a hard stop for two purposes; 1) to provide a positive and secure locking point to properly secure the nut 125a and prevent back-out; 2) to provide clearance between the nut 125a and the plate 105 to allow the plate 105 to move along its length within the slots. The purpose of these slots is to provide potential for lateral growth of the ribs as the patient matures.

[0060] Fig.12 A rectangular rotator 122 is shown that allows rotation along the axis of the threaded portion 120c, and is secured using a pair of nuts 130a, b on one side of the boss. A locking nut 130b engages the upper surface of the rotator 122 and secures it to the rear surface of the transverse process hook 110 (not shown). The securing action eliminates axial rotation of the rotator 122 to prevent the tail end of the rib head from rotating. The transverse process hook 110 (not shown) and the rotator 122 do not allow the plate to slide along its length relative to the transverse process hook 110 (not shown).

[0061] Fig.13 A rib fixation post 120a is shown with a circular boss 123 that provides a smooth surface for the spring plate to translate along its length. The lower threaded portion engages the rib hook 115a (not shown) and the trocar tip is used to drill into the bone. The hexagonal boss 124 provides a hard stop against the rear surface of the rib hook 115a (not shown). The uppermost threaded portion of the post 120a is used to secure a nut 125a (not shown) to the fixation plate 105 (not shown). The nut 125a (not shown) is tightened against the uppermost surface of the circular boss 123 to provide a secure nut fixation, rather than being directly fixed to the spring plate 105 (not shown), thereby causing it to slide relative to the fixation hook 115a (not shown).

[0062] Fig.14 Shown is a top device for regulating the growth of an immature rib 100 implanted into the transverse process of a vertebra 140 and attached along the length of a rib 145. The transverse process 110 utilizes a rotator that locks rotation about its axis. Two hooks 115a, 115b attached to the rib are slotted to allow growth along the length of the rib.

[0063] Alternatively, pedicle screw constructs can be used to connect the spine, e.g. Fig.15A and 15B As shown. The inner portion of the spring plate 105 may have a male post 150 that fits into the flared head 155 of the screw and is then secured with a locking set screw 160. This will provide rotational fixation for the pedicle screw. The pedicle screw head 155 may be fixed, uniaxial, or polyaxial. Alternatively, as Fig.16 As shown, there are only two hooks 115a, 115b attached to the ribs, medial and lateral.

[0064] In vitro rib specimens were subjected to mechanical evaluation. A series of mechanical tests were performed on individual ribs with and without plates attached. Flexural loads were placed through the rib (medial to lateral) and the resulting deflections and loads were measured over a series of five quasi-static loading cycles. The tests were performed on full-length ribs where the rib was nailed near the rib head and a second parallel nail was placed through the most anterior cortex of the rib, as shown in Figure 2. Fig.17 A second test was then performed with the anterior pin placed as close as possible to the lateral rib hook and the test was repeated in the same manner. The second part of this test was specifically designed to study the effect of the spring plate on the medial portion of the rib where the bending loads are greatest and anatomical deformations are most prevalent.

[0065] A total of 28 ribs were tested full length, and the results showed an average increase in bending stiffness (N / mm) of 16.64% (standard deviation = 14.07). In the shortened configuration, a total of 25 ribs were tested, and the results showed an average increase in stiffness of 24.24% (standard deviation = 10.62).

[0066] The third part of the mechanical evaluation involved full-length testing of the rib with the plate mounted. The purpose of this test was to evaluate the cyclic integrity of the mounted hardware and any impacts the hardware may have on the bone. A small deflection bending load was placed through the rib structure with the ribs immersed in a saline solution. To simulate rapid breathing, a 2mm deflection was repeated at a rate of 2Hz. One rib was tested a total of 198k times before cracking occurred midway between the front attachment point and the lateral rib hook, as shown in Figure 1. Fig.18 The second sample was tested in the same manner for 254k cycles without hardware or bone failure.

[0067] After general anesthesia, the animal was placed in the prone position. An 8-cm incision was made parallel to the midline of the spinous process and 2 cm lateral to the convex (right) side of T8 to 10 (apex), as shown in Figure 2. Fig.19 The right paraspinal muscle will be dissected superficial to the tip of the transverse process. The costovertebral ligaments are identified without damaging the lamina and adjacent facet joints, as shown in Figure 1. Fig. 20 The marking point for the transverse hook insertion is just above the medial edge of the costovertebral ligament, as shown in Fig.21 A custom-made probe will be used to find the space between the transverse process and the rib head. The transverse hook is then inserted and secured with a transverse fixation screw, as shown in Figure 2. Fig. 22 shown.

[0068] Using the same incision, the medial rib hook will be fixed to the medial portion of the rib. The medial rib hook mark is located 2 cm lateral to the lateral hook. The rib will be exposed subperiosteally. The medial rib hook is inserted and fixed with the rib hook screw, as shown in the figure below. Fig.23For lateral rib hook insertion, an 8 cm lateral skin incision is made parallel to and 7 cm lateral to the medial incision. The lateral rib hook will be secured using the same technique. The lateral hook and rib hook will be secured at three vertices from T8 to T10.

[0069] The flat spring plate will be inserted subcutaneously through the medial incision into the lateral incision, such as Fig.24 As shown. In the medial part, the plate is placed submuscularly through the rectangular rotator and rib screw posts and fixed to the lateral hook and medial hook. 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, as shown Fig.25 As shown. Then lock the plate with screw-nuts. On the outer part, bend the plate down to lock it on the outer hook with screw-nuts. Place three spring plates horizontally at the top of T8 to T10, as shown. Fig.26 After the plate is placed, the soft tissue will be closed in layers. Anteroposterior and lateral radiographs of the spine will be performed in both animals to record the baseline contour of the spine.

[0070] like Fig. 27 Shown is a one-month-old pig with a 47° right thoracic scoliosis (A). One month later, hook-spring plates were fixed at three apical levels on the convex side (B). Immediately after surgery, the scoliosis was corrected to 30°.

[0071] Fig.28Another embodiment of the present invention is shown as a device 2800 for regulating the growth of an immature rib. Device 2800 is similar to device 100, except that device 2800 includes a generally flat spring plate 2805 having an inclined portion at its lateral end. Device 2800 also includes a medial rib hook 2810 disposed along the body of spring plate 2805 and configured to be secured to spring plate 2805 and ribs via medial rib fixation screws 2815 and medial rib locking nuts 2820. Device 2800 also includes a lateral rib hook 2825 disposed at the lateral end of spring plate 2800 and configured to be secured to spring plate 2805 and ribs via lateral rib fixation screws 2830 and lateral rib locking nuts (not shown). At the medial end of spring plate 2805, device 100 includes a polyaxial pedicle screw 2835. The polyaxial pedicle screw 2835 at the medial end of the device 100 is configured to fix the device 2800 to the vertebra. The polyaxial pedicle screw 2835 shown has a flared head, but it can also have other types of heads. The thickness of the spring plate 2805 increases at the medial end to provide increased bending stiffness near the rib head where the bending load is highest. The spring plate 2805 can be made of materials such as polyetheretherketone (PEEK), titanium, stainless steel, or ultra-high molecular weight polyethylene (UHMWPE) and provide an elastic spring function when bent along its length. Although embodiments of the present invention are discussed herein including spring plates made of PEEK, PEEK is a non-limiting exemplary material, and the spring plate can be made of any biocompatible material that provides an appropriate elastic spring function when bent along its length. The structure and function of the medial rib hook 2810 and the lateral rib hook 2830 are similar to other rib hooks described herein, for example, rib hooks 115a, 115b.

[0072] One embodiment of the present application includes a kit comprising a device for regulating the growth of an immature rib, such as device 2800, one or more tools for operating 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, such as those included in device 2800.

[0073] One embodiment of the present application includes a method of regulating the growth of an immature rib, the method including providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, such as device 2800; and attaching the device to the immature rib.

[0074] Fig.29A A spring plate is shown with a slot into which a flared head pedicle screw is inserted prior to installation. Fig.29BA wrench is shown which is used to align a spring plate using a flared head pedicle screw by turning the wrench.

[0075] Fig. 30A and 30B The working principle of device 2800 is shown below. Fig. 30A The deformed ribs of an EOS patient are shown when the device 2800 is attached to the ribs. The arrows represent the forces applied by the device 2800 to the ribs. Fig. 30B The rib is shown after the device has been applied to the rib for a period of time.

[0076] Fig.31A and 31B An image of a patient prior to implantation of device 2800 is shown. Fig.31A An internal image of the patient's spine and ribs is shown and the intended function of the device 2800 is indicated. Fig.31B An external image of a patient and the intended effect of device 2800 is shown.

[0077] Fig.32 Images of a control subject and a treated subject in an in vivo animal trial of the device 2800 are shown. The first pair of images (from Fig.32 The first pair of images (starting on the right of the figure) shows the control subject and the treated subject in the preoperative phase of the trial. The second pair of images shows the control subject and the treated subject two months after surgery to induce scoliosis. The third image of the treated subject (without a matched control subject) shows the treated subject just after the device 2800 has been implanted. The fourth, fifth, and sixth sets of images show the control subject and the treated subject four months after surgery to induce scoliosis and two months after the treated subject has had the device 2800 implanted.

[0078] Fig.33A and 33B 2 is a top view of a rib of a treated subject having device 2800 implanted in the rib to demonstrate the effect of device 2800 on the rib, and a control subject having no device 2800 implanted in the rib.

[0079] Figures 34A-34D Control subjects and treated subjects in a trial of device 2800 are shown. Fig.34A and Fig.34C Anterior and posterior images of a curved spine and deformed thorax, respectively, of a control subject without implantation of device 2800 are shown. Fig.34B and 34D Anterior and posterior images of the spine and thorax, respectively, of a treated subject in which the device 2800 is implanted are shown.

[0080] Fig.35A and 35BImages of the treated subject are shown immediately after implantation and two months after implantation of the device. The yellow arrows show evidence of rib growth.

[0081] Figures 36A-36D The treated subject before and after implantation of the device 2800. Fig.36A Shown is a treated subject prior to implantation. Fig.36B Shown are treated subjects 7 days after implantation. Fig.36C Shown is a treated subject 19 days after implantation, Fig.36D A treated subject is shown 60 days after implantation of device 2800.

[0082] Children with EOS often have spinal and chest wall deformities that impair respiratory function and postnatal lung growth. Although significant advances have been made in the understanding and treatment of EOS over the past decade, much work still needs to be done to enhance current treatment strategies to maximize respiratory function and improve quality of life for these patients. This new hook-spring plate implant system will provide: 1) a growth-modulating approach to the immature ribs to dynamically correct rib deformities and correct rotational deformities of the vertebrae to increase thoracic volume and correct scoliosis; 2) augmentation of the immature ribs to prevent and arrest rib hump and scoliosis progression; 3) a delaying strategy to reduce progression of spinothoracic deformity; and 4) replacement of casts or struts or working in conjunction with these treatments. This new implant system will be particularly useful for patients with challenging EOS.

[0083] Any and all aspects of the embodiments disclosed in this application may exist together in any single embodiment unless prevented by physical impossibility.

[0084] In one embodiment, a device for regulating the growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to an immature 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 one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial or caudal direction. In one aspect, each rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In one aspect, each transverse hook is configured to be attached to the transverse process of a vertebra by a threaded post, and wherein the spring plate is configured to be attached to the transverse hook by a locking nut on the threaded post. In one 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 via a set screw on each rib hook. In one 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 via a set screw.

[0085] In another embodiment, a kit for a device for regulating the growth of an immature rib comprises, consists essentially of, or consists of: the device for regulating the growth of an immature rib comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to an immature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; a plurality of set screws or a plurality of threaded posts and locking nuts for attaching the device to the immature rib and the transverse process; and one or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, wherein the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide force in a cranial direction or a caudal direction.

[0086] In another embodiment, a method of regulating the growth of an immature rib comprises, consists essentially of, or consists of: providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to an immature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; and attaching the device to the immature rib and the vertebra. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial direction or a caudal direction. In one aspect, each rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post. In one aspect, each transverse hook is configured to attach to a transverse process of a vertebra via a threaded post, and wherein the spring plate is configured to attach to the transverse hook via a locking nut on the threaded post. In one aspect, each rib hook is configured to attach to an immature rib, and the spring plate is configured to attach to each rib hook via a set screw on each rib hook. In one aspect, the transverse hook is configured to attach to a transverse process of a vertebra, and the spring plate is configured to attach to the transverse hook via a set screw.

[0087] In another embodiment, a device for regulating growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide a resilient spring function when bent along its length; and two rib hooks, each configured to secure the spring plate to the immature rib. In one aspect, each rib hook is configured to be attached to the immature rib via a threaded post, and wherein the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post.

[0088] In another embodiment, a kit of devices for regulating the growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a plurality of set screws or a plurality of threaded posts and locking nuts for attaching the device to the immature rib; and one or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts.

[0089] In another embodiment, a method of regulating the growth of an immature rib comprises, consists essentially of, or consists of: providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide a resilient spring function when bent along its length; and two rib hooks, each configured to secure the spring plate to the immature rib; and attaching the device to the immature rib.

[0090] In another embodiment, a device for regulating the growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a pedicle screw configured to secure the spring plate to the vertebra. In one aspect, each rib hook is configured to be attached to the immature rib via a threaded post, and wherein the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post. In one aspect, the pedicle screw includes 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.

[0091] In another embodiment, a kit of devices for regulating the growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to an immature rib; a pedicle screw configured to secure the spring plate to a vertebra; a plurality of set screws or a plurality of threaded posts and locking nuts for attaching the device to the immature rib and vertebrae; and one or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts.

[0092] In another embodiment, the present application provides a method for regulating the growth of an immature rib, comprising, consisting essentially of, or consisting of: providing a human patient in need of regulating the growth of an immature rib; providing a device for regulating the growth of an immature rib, wherein the device comprises: a spring plate configured to provide an elastic spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a pedicle screw configured to secure the spring plate to a vertebra; and attaching the device to the immature rib.

[0093] In another embodiment, a device for regulating the growth of an immature rib comprises, consists essentially of, or consists of: a spring plate configured to provide an elastic spring function when bent along its length; a medial rib hook disposed near the medial end of the spring plate and configured to secure the spring plate to the immature rib; a lateral rib hook disposed near the lateral end of the spring plate and configured to secure the spring plate to the immature rib; and a pedicle screw disposed at the medial end of the spring plate and configured to secure the spring plate to the vertebra. In one aspect, the spring plate includes an inclined portion at its lateral end. In one aspect, the spring plate is made of polyetheretherketone, titanium, stainless steel, or ultra-high molecular weight polyethylene. In one aspect, the thickness of the spring plate increases at the medial end. In one aspect, the spring plate is biased to provide a force in a cranial direction or a caudal direction. In one aspect, each of the medial rib hook and the lateral rib hook is configured to be attached to the immature rib by a threaded post, and wherein the spring plate is configured to be attached to each rib hook by a locking nut on each threaded post.

[0094] It should be understood that the specific embodiments described herein are presented by way of illustration rather than limitation of the present invention. Without departing from the scope of the present invention, the main features of the present invention may be adopted in various embodiments. Those skilled in the art will recognize or be able to use no more than routine experiments to determine many equivalents of the specific processes described herein. Such equivalents are considered to be within the scope of the present invention and are covered by the claims.

[0095] All publications and patent applications mentioned in the specification are indicative of the technical level of those skilled in the art to which the invention belongs. All publications and patent applications are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0096] When used in conjunction with the term "comprising" in the claims and / or the specification, a noun without a quantifier may mean "one", but may also mean "one or more", "at least one", and "one or more than one". Unless explicitly indicated to refer only to alternatives or the alternatives are mutually exclusive, the use of the term "or" in the claims means "and / or", but the disclosure also supports limitations referring only to alternatives and "and / or". In this application, the term "about" is used to indicate that a value includes the inherent error variation of a device, a method for determining a value, or the variation that exists between research subjects.

[0097] As used in this specification and claims, the words "comprising" (and any forms thereof, such as "comprise" and "comprises"), "having" (and any forms thereof, such as "have" and "has"), "including" (and any forms thereof, such as "includes" or "include"), or "containing" (and any forms 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, "comprising / including / containing" may be replaced with "consisting essentially of" or "consisting of". As used herein, the phrase "consisting essentially of" requires the specified integers or steps and integers or steps that do not materially affect the features or functions of the claimed invention. As used herein, the term "consisting of" is used to indicate that only the listed integers (e.g., features, elements, characteristics, properties, method / process steps, or limitations) or groups of integers (e.g., one or more features, one or more elements, one or more characteristics, one or more properties, one or more method / process steps, or one or more limitations) are present.

[0098] As used herein, the term "or a combination thereof" refers to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or a combination thereof" is intended to include at least one of the following: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular case, BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, explicitly included are combinations of repetitions containing one or more items or terms (such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, etc.). It will be appreciated by those skilled in the art that, unless apparent from the context, there is generally no limit to the number of items or terms in any combination.

[0099] As used herein, approximate words such as, but not limited to, "about," "substantially," or "approximately" refer to conditions that, when so modified, are understood not to be necessarily absolute or exact, but rather to be close enough for one of ordinary skill in the art to ensure that the condition exists. The degree to which the description can vary will depend on how much of a change can be made and one of ordinary skill in the art can still recognize the modified feature as still having the desired properties and capabilities of the unmodified feature. In general, but subject to the preceding discussion, numerical values ​​modified herein by approximate words such as "about" may vary from the stated value by at least ±1, 2, 3, 4, 5, 6, 7, 10, 12, or 15%.

[0100] In light of the present disclosure, all devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation. Although the devices and methods of the present invention have been described in terms of specific embodiments, it is obvious to those skilled in the art that changes can be implemented in the compositions and / or methods described herein and in the steps or sequence of steps of the methods without departing from the concept, spirit and scope of the present invention. All such similar substitutions and modifications apparent to those skilled in the art are deemed to fall within the spirit, scope and concept of the present invention as defined by the appended claims.

[0101] Furthermore, the details of construction or design shown herein are not intended to be limited except as described in the appended claims. Therefore, it is clear that the specific embodiments disclosed above may be changed or modified, and all such changes are considered to be within the scope and spirit of the present disclosure. Therefore, the protection sought herein is as described in the appended claims.

[0102] Without departing from the scope of the present invention, the systems and devices described herein may be modified, added, or omitted. The components of the systems and devices may be integrated or separated. In addition, the operations of the systems and devices may be performed by more, fewer, or other components. The methods may include more, fewer, or other steps. In addition, the steps may be performed in any suitable order.

[0103] To assist the Patent Office and any reader of any patent issued upon this application in interpreting the claims appended hereto, Applicants wish to note that unless the phrase "means for" or "step for" is expressly used in a particular claim, Applicants do not intend that any of the appended claims would trigger 35 U.S.C. § 112(f) by virtue of its existence as of the filing date. References

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 5. Beauchamp EC, Anderson RCE, and Vitale MG. Modern Surgical Management of Early Onset and Adolescent Idiopathic Scoliosis. Neurosurgery, 2019;84(2):291-304.

[0109] 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.

[0110] 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.

[0111] 8. Zhang H and Sucato DJ. Neurocentral synchondrosis screws to create and correct experimental deformity. Clin Orthop Relat Res, 2011: 469: 1383-1390.

[0112] 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. A device for regulating the growth of immature ribs, comprising: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; as well as A transverse hook is configured to secure the spring plate to a transverse process of a vertebra.

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

3. The device according to claim 1, wherein: The thickness of the spring plate increases at the inner end.

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

5. The device according to claim 1, wherein: Each rib hook is configured to be attached to the immature rib via a threaded post, and the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post.

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

7. The device according to 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 via a set screw on each rib hook.

8. The device according to 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 via a set screw.

9. A kit of parts for regulating the growth of an immature rib, comprising: The device for regulating the growth of immature ribs comprises: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; a plurality of set screws or a plurality of threaded posts and lock nuts for attaching the device to the immature rib and the transverse process; and One or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts.

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

11. The kit of claim 9, wherein: The thickness of the spring plate increases at the inner end.

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

13. A method for regulating the growth of an immature rib, comprising: providing a human patient in need of regulating the growth of an immature rib; A device for regulating the growth of the immature rib is provided, wherein the device comprises: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a transverse hook configured to secure the spring plate to a transverse process of a vertebra; and The device is attached to the immature rib and the vertebra.

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

15. The method according to claim 13, wherein: The thickness of the spring plate increases at the inner end.

16. The method according to claim 13, wherein: The spring plate is biased to provide force in either the cranial or caudal direction.

17. The method according to claim 13, wherein: Each rib hook is configured to be attached to the immature rib via a threaded post, and the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post.

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

19. The method according to 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 via a set screw on each rib hook.

20. The method according to 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 via a set screw.

21. A device for regulating the growth of an immature rib, comprising: a spring plate configured to provide a resilient spring function when bent along its length; as well as Two rib hooks are each configured to secure the spring plate to the immature rib.

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

23. A kit of parts for regulating the growth of an immature rib, comprising: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; a plurality of set screws or a plurality of threaded posts and lock nuts for attaching the device to the immature rib; as well as One or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts.

24. A method for regulating the growth of an immature rib, comprising: providing a human patient in need of regulating the growth of an immature rib; A device for regulating the growth of the immature rib is provided, wherein the device comprises: a spring plate configured to provide a resilient spring function when bent along its length; and two rib hooks, each configured to secure the spring plate to the immature rib; and The device is attached to the immature rib.

25. A device for regulating the growth of an immature rib, comprising: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; as well as The pedicle screw is configured to fix the spring plate to the vertebra.

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

27. The device according to claim 25, wherein: The pedicle screw includes 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. A kit of parts for regulating the growth of an immature rib, comprising: a spring plate configured to provide a resilient spring function when bent 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 set screws or a plurality of threaded posts and lock nuts for attaching the device to the immature ribs and the vertebrae; and One or more tools for operating the plurality of set screws or the plurality of threaded posts and locking nuts.

29. A method for regulating the growth of an immature rib, comprising: providing a human patient in need of regulating the growth of an immature rib; A device for regulating the growth of the immature rib is provided, wherein the device comprises: a spring plate configured to provide a resilient spring function when bent along its length; two rib hooks, each configured to secure the spring plate to the immature rib; and a pedicle screw configured to secure the spring plate to a vertebra; and The device is attached to the immature rib.

30. A device for regulating the growth of an immature rib, comprising: a spring plate configured to provide a resilient spring function when bent along its length; a medial rib hook disposed proximate a medial end of the spring plate and configured to secure the spring plate to the immature rib; a lateral rib hook disposed proximal to the lateral end of the spring plate and configured to secure the spring plate to the immature rib; as well as A pedicle screw is disposed at the medial end of the spring plate and is configured to fix the spring plate to a vertebra.

31. The device according to claim 30, wherein The spring plate includes an inclined portion at an outer side end thereof.

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

33. The device according to claim 30, wherein: The thickness of the spring plate increases at the inner end.

34. The device according to claim 30, wherein: The spring plate is biased to provide force in either the cranial or caudal direction.

35. The device according to claim 30, wherein: Each of the medial rib hook and the lateral rib hook is configured to be attached to the immature rib via a threaded post, and the spring plate is configured to be attached to each rib hook via a locking nut on each threaded post.

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