Bone lengthening device and method of use thereof

Abstract

The present invention relates to an implantable bone distraction device. The implantable bone distraction device includes an inner rod defining an internal cavity that houses a rotation actuator. The rotation actuator has an output shaft that is disposed at the end of the inner rod and connected to a lead screw that threadably engages a threaded inner surface of the outer rod. Rotating the lead screw converts the rotational motion into linear motion, resulting in telescoping motion of the outer rod relative to the inner rod. The rotational motion is converted into linear motion by components arranged in a parallel configuration, thereby minimizing the overall length of the bone distraction device while maintaining a maximum stroke length. In various embodiments, additional components, such as an electronic circuit board, an electrical or battery power source, may be housed within the internal cavity defined by the inner rod.

Description

Technical Field

[0001] The present invention generally relates to bone lengthening devices, and more particularly, to a compact bone lengthening device and method for lengthening the bones of pediatric patients and correcting scoliosis.

Background Art

[0002] Distraction osteogenesis is a surgical method for lengthening bones. Distraction osteogenesis consists of controlled osteotomy followed by gradually controlling and pulling two bone ends using a mechanical device that applies a stretching force to stimulate the growth of new bone. In the distraction stage, the distraction device pulls the two bone ends at a specific speed and rhythm, typically 1.0 mm per day.

[0003] In this technical field, various distraction devices are known. US Patent Application Publication No. 2016 / 0058483 (Stauch) discloses an intramedullary pin for lengthening tubular bones, the intramedullary pin comprising a hollow body including axially displaceable first and second inner portions, and a drive unit for generating axial displacement of the first inner portion relative to the second inner portion. An electrical cable supplies power to the drive unit and enables transmission of sensor signals from the device. US Patent Application Publication No. 2011 / 0060336 (Pool) discloses an intramedullary lengthening device, which comprises an actuator having a housing including a rotatable permanent magnet actuator, and a movable distraction shaft telescopically attached to the housing. The distraction shaft is operably coupled to a rotatable permanent magnet via a lead screw. US Patent Application Publication No. 2017 / 0333080 (Roschak) discloses a remotely adjustable interactive bone remodeling implant. This comprises an implant body, an actuator coupled to the implant body, a sensor configured to detect parameters indicating a biological state, a transceiver, and a controller.

[0004] Early-onset scoliosis (EOS) is another bone-related problem involving spinal deformity, which develops in children, particularly before the lungs are fully mature, between the ages of 8 and 10. Treating EOS remains challenging, as the focus is on reducing and controlling spinal curvature while maintaining spinal and rib cage growth. Growth rods are a popular treatment for EOS because they can prevent worsening of curvature while allowing spinal growth. Traditionally, using growth rods required open-procedure distraction approximately every six months. Such open-procedure distractions are burdensome, carrying a high risk of anesthesia and wound complications. Furthermore, repeated surgeries under general anesthesia can negatively impact brain development, which is particularly important for young children. As a result of the shortcomings associated with conventional growth rods (TGRs), the development of alternative technologies from the background has become apparent.

[0005] U.S. Patent Application Publication 2014 / 0031870 (inventors Chang et al.) discloses a magnetically controlled growth rod ("MCGR") that enables gradual lengthening on an outpatient basis. The MCGR uses a large external magnet to enable periodic, non-invasive spinal lengthening under continuous neurological observation of an awake patient. U.S. Patent Application Publication 2006 / 0009767 (inventors Kiester) discloses a spinal curvature correction of the spine, which involves using an extension rod that is completely isolated beneath the skin and attached at opposite ends of the rod to a selected portion of the spinal curvature of the spine, and generating a force controlled by the extension of the rod over an extended period under external control until the desired spinal curve is achieved. U.S. Patent Application Publication 2015 / 0250505 (inventors Ross) discloses a remotely controllable growth rod device, which comprises onboard electronics having a microprocessor configured to receive remotely transmitted motion data by a receiver, and further performing feedback-controlled operation of a drive assembly.

[0006] Unlike TGR, the above techniques allow for distraction during outpatient visits, thus avoiding the risk of repeated surgical lengthening procedures. Furthermore, distractions may be performed more frequently to more accurately mimic normal physiological growth. This offers significant advantages for children as it eliminates the need for rod distraction under general anesthesia. Additionally, it may have the benefit of increasing spinal length by avoiding spinal autofusion associated with sudden, forceful distractions at irregular intervals. However, further technological advancements are needed, including miniaturization of the device, personalized protocols, and follow-up of postoperative care. [Overview of the Initiative]

[0007] While various devices known in this field are generally suitable for their intended specific applications, they are considered too large for use in treating pediatric cases. Furthermore, the configurations and mechanisms used by devices in the background technology are generally unsuitable for miniaturization to accommodate the smaller bone dimensions of children unless the stroke length is significantly reduced. In particular, bone lengthening devices in the background technology rely on mechanical action in which the actuator is configured in series with the distraction rod, resulting in excessive device length. Therefore, there is a need for advancements in the field of bone lengthening to effectively treat pediatric cases.

[0008] The technologies described in the above sections are not intended to imply that any patents, publications, or other information referred to herein constitute “background art” relating to the present invention, unless otherwise specifically designated. Furthermore, the above sections shall not be construed as meaning that a search has been conducted or that no other relevant information as defined in 37 Title 1.56(a) exists.

[0009] The present invention overcomes the limitations present in the background art by providing an advance in the field of bone lengthening devices and methods particularly suited for use in lengthening bones in pediatric patient cases and in treating pediatric scoliosis. According to the first embodiment, the present invention provides an implantable bone lengthening device comprising an outer rod and an inner rod configured in a screw-type telescopic engagement. The inner rod defines an internal cavity, which houses a rotary actuator having an output shaft connected to a lead screw, the lead screw positioned at the end of the inner rod and screw-engaging with a threaded inner surface of the outer rod. By rotating the lead screw, rotational motion is converted into linear motion, resulting in the outer rod telescopically extending and retracting relative to the inner rod. An important aspect of the present invention is to provide a configuration in which the components that ensure the conversion of rotational motion into linear motion, namely the actuator and lead screw assembly on the one hand and the outer rod on the other, are arranged in a parallel configuration. This minimizes the overall length of the bone lengthening device while maintaining the maximum stroke length. In various embodiments, additional components such as electronic circuit boards, power supplies, or battery power supplies may be housed within an internal cavity formed by an internal rod. The bone lengthening device of the present invention may be fixed to bone in various configurations, including implantation into the medullary cavity of the bone, attachment to the outer surface of the bone, or attachment to the bone as an extramedullary plate.

[0010] Therefore, an object of the present invention is to provide advances in the field of bone lengthening devices and methods.

[0011] Another object of the present invention is to provide an improved bone lengthening device configured for use in lengthening bones, particularly in pediatric patient cases.

[0012] Another object of the present invention is to provide a bone lengthening device in which the mechanical structure that ensures rotational motion and converts it into linear motion is configured in parallel, thereby minimizing the total length of the stored portion while maintaining the maximum stroke length.

[0013] Another objective of the present invention is to provide an advance in treatment techniques for early-onset scoliosis.

[0014] These and other objectives are achieved by the present invention, which will become even clearer from the attached drawings, the detailed description of the drawings below, and preferred embodiments. [Brief explanation of the drawing]

[0015] [Figure 1] This is a schematic cross-sectional view of a bone lengthening device of background technology, which includes an actuator and lead screw assembly screw-engaged in series with an internal rod to reliably convert rotational motion into linear motion. [Figure 2] This is a schematic cross-sectional view of a bone lengthening device according to the present invention, which includes an actuator and a lead screw configured in parallel with an outer rod to reliably convert rotational motion into linear motion. [Figure 3A] This is a schematic cross-sectional view of the bone lengthening device according to the present invention in a storage configuration. [Figure 3B] This is a schematic cross-sectional view of the device shown in Figure 3A in the case of an extended configuration. [Figure 3C] Figure 3B is a partial schematic detail diagram of the device shown. [Figure 3D] Figure 3C is a partial schematic detail view, an exploded view of the device shown. [Figure 4] This is a schematic cross-sectional view of an alternative embodiment of a bone lengthening device according to the present invention, which is configured with an electric motor and a reduction gear. [Figure 5] This is a schematic cross-sectional view of an alternative embodiment of a bone lengthening device according to the present invention, comprising a rotary actuator and an electronic circuit. [Figure 6] This is a schematic cross-sectional view of an alternative embodiment of a bone lengthening device according to the present invention, which is configured with an internal power supply. [Figure 7] This is a schematic cross-sectional view of an alternative embodiment of a bone lengthening device according to the present invention, comprising a transplantable remote power supply module. [Figure 8]Schematic cross-sectional view of an alternative embodiment configured with a bearing. [Figure 9A] Schematic cross-sectional view of an alternative embodiment configured with various seals. [Figure 9B] Schematic cross-sectional view of an alternative embodiment configured with various seals. [Figure 10] Schematic cross-sectional view of an alternative embodiment configured with a vent. [Figure 11] Schematic cross-sectional view of an alternative embodiment configured with a radially enlarged inner rod tip. [Figure 12A] Schematic cross-sectional view of an alternative embodiment composed of a sheath covering an outer rod within a fixed assembly having an inner rod. [Figure 12B] Schematic cross-sectional view showing the sheath configuration of another alternative embodiment together with the device in the storage configuration. [Figure 12C] Schematic cross-sectional view showing the embodiment shown in FIG. 12B and having a partially extended configuration. [Figure 13] Schematic cross-sectional view of an alternative embodiment configured with a guide bush. [Figure 14] Schematic cross-sectional view of an alternative embodiment configured with a fillet end. [Figure 15] Partial cross-sectional detail view providing a detailed drawing of a structure that enables a sliding engagement between an inner rod and an outer rod. [Figure 16A] Schematic cross-sectional view showing inner and outer rod ends having a fastener receiving opening for use in attaching the device to a bone segment. [Figure 16B] Schematic cross-sectional view showing inner and outer rod ends having a fastener receiving opening for use in attaching the device to a bone segment. [Figure 17] Schematic cross-sectional view showing a device adapted using a lateral fixing plate. [Figure 18A] Comparison diagram between the prior art device (18A) and the device according to the present invention (18B), showing the compact length of the present invention in the storage configuration. [Figure 18B] This is a comparative diagram of the device in the background technology (18A) and the device according to the present invention (18B), showing the compact length of the present invention in a storage configuration. [Figure 19A] This is a comparative diagram of a device in the background technology (19A) and a device according to the present invention (19B), showing the even longer stroke length achieved by the present invention. [Figure 19B] This is a comparative diagram of a device in the background technology (19A) and a device according to the present invention (19B), showing the even longer stroke length achieved by the present invention. [Figure 20A] This is a comparison diagram of the device in the background technology (20A) and the device according to the present invention (20B), showing the longer guide length achieved by the present invention for the same stroke length achieved by the device in the background technology. [Figure 20B] This is a comparison diagram of the device in the background technology (20A) and the device according to the present invention (20B), showing the longer guide length achieved by the present invention for the same stroke length achieved by the device in the background technology. [Figure 21A] This is a comparative diagram of the device in the background technology (21A) and the device according to the present invention (21B), showing that the internal volume available for housing an electromechanical system in the present invention is larger compared to the device in the background technology. [Figure 21B] This is a comparative diagram of the device in the background technology (21A) and the device according to the present invention (21B), showing that the internal volume available for housing an electromechanical system in the present invention is larger compared to the device in the background technology. [Figure 22] This demonstrates the use of the bone lengthening device according to the present invention as an intramedullary lengthening device. [Figure 23] This invention demonstrates the use of a bone lengthening device as an extramedullary lengthening device. [Figure 24] This invention demonstrates the use of a bone lengthening device as an extramedullary lengthening device associated with an intramedullary reinforcement material. [Figure 25]The present invention presents another embodiment of a bone lengthening device as an extramedullary lengthening device. [Figure 26] An embodiment of the bone lengthening device according to the present invention, which communicates wirelessly with an external control unit, is shown. [Figure 27] An embodiment of the bone lengthening device according to the present invention is shown, configured to receive power wirelessly and communicate wirelessly with an external control unit. [Figure 28] An embodiment of the bone lengthening device according to the present invention is shown, which is wired to a portable power supply module and configured for wireless external control. [Figure 29] An embodiment of the bone lengthening device according to the present invention, which is wired to an implantable power receiving module and configured for wireless external control, is shown. [Figure 30A] This is a cross-sectional view of the bone lengthening device according to the present invention in both a storage configuration and an extension configuration. [Figure 30B] This is a cross-sectional view of the bone lengthening device according to the present invention in both a storage configuration and an extension configuration. [Figure 31A] This is a perspective cross-sectional view of the bone lengthening device according to the present invention in both a storage configuration and an extension configuration. [Figure 31B] This is a perspective cross-sectional view of the bone lengthening device according to the present invention in both a storage configuration and an extension configuration. [Figure 32] This is an exploded perspective cross-sectional view of the bone lengthening device according to the present invention. [Figure 33] This is a partially exploded perspective view of the inner rod lug and outer rod lug, showing how rotational movement between the inner rod and outer rod is restricted. [Figure 34] This is a cross-sectional view showing the mating engagement between the inner rod lug and the outer rod lug. [Figure 35] This is a partial cross-sectional view of the device showing the inner rod lug. [Figure 36A] This is a cross-sectional view obtained along the line 36A-36A in Figure 35, showing the partially threaded inner surface of the outer rod. [Figure 36B] This is a cross-sectional view obtained along the line 36B-36B in Figure 35, showing the partially threaded inner surface of the outer rod. [Figure 37A] This is a side view showing through bores located at opposite ends of the device. [Figure 37B] This is a perspective view of the configuration shown in Figure 37A. [Figure 38A] This is a side view showing alternative through-bore configurations at the mutually opposite ends of the device. [Figure 38B] This is a perspective view of the configuration shown in Figure 38A. [Figure 39] This is a side view showing a through-bore composed of vertical and oblique angles. [Figure 40A] This is a side cross-sectional view emphasizing the distal and proximal axial stopping portions. [Figure 40B] This is a perspective cross-sectional view of the configuration shown in Figure 40A. [Figure 41] This shows an alternative configuration for a device having a through-bore defined in a protruding flange. [Figure 42] This describes one embodiment of a bone lengthening device fixed to the patient's spine. [Figure 43] Another embodiment is shown, illustrating a pair of bone lengthening devices fixed to the patient's spine. [Modes for carrying out the invention]

[0016] The present invention is more readily comprehensible by referring to the following detailed description taken in connection with the accompanying drawings, which constitute part of this disclosure. The present invention is not limited to any specific device, method, condition, or parameter described and / or shown herein, and the terms used herein are for illustrative purposes to describe specific embodiments and are not intended to limit the claimed invention. Any patents and other publications identified herein are incorporated by reference as if they were fully described herein.

[0017] In describing the present invention, the term "joined" is used. "Joined" means that the article or structure referred to is joined directly or indirectly to another article or structure. "Indirectly joined" means that there is an intervening article or structure between the two articles that are "joined". "Directly joined" means that the two articles or structures are in contact with each other or are essentially continuous. "Adjacent to a structure" means located near the specified structure.

[0018] Furthermore, as used herein in connection with the appended claims, the singular forms “a,” “an,” and “the” include their plural forms. Reference to a particular number includes at least that particular number unless the context clearly indicates otherwise. In this specification, range may represent a range from a particular value to and / or to another particular value, “about” or “approximately.” Where such a range is expressed, in another embodiment it includes from a particular value to and / or to another particular value. Similarly, where a value is expressed as an approximation, the use of the preceding term “about” is understood to mean that a particular value forms another embodiment.

[0019] Next, looking at the drawings, Figure 1 is a schematic diagram of a bone lengthening device according to the background art, generally denoted by reference numeral 100, in which the components that convert rotational motion to linear motion are configured in series, as will be further described herein. Figure 1 depicts the background art device 100 in a non-extension configuration. The background art device 100 includes an outer rod 102 housing a rotary actuator 104, which is directly coupled in series to an externally threaded lead screw 106 that is screw-engaged with an inner rod 108. The rotational operation of the lead screw 106 extends the inner rod 108 relative to the outer rod 102. In the context of the present invention, the background art configuration in which the rotary actuator 104, the lead screw 106, and the threaded inner rod 108 are arranged as seen in Figure 1 shall be interpreted as a configuration in which the aforementioned components are mechanically arranged in "series". As is most commonly seen in Figure 1, the mechanical configuration in which the rotary actuator 104 and the lead screw 106 are fixedly housed in series within the outer rod 102 results in a device with an excessive overall length.

[0020] Figures 2 to 32 disclose various embodiments of an implantable bone lengthening / extension device according to the present invention and a method of using the same. Figure 2 provides a schematic example of a bone lengthening device relating to the present invention, generally denoted by reference numeral 200. More specifically, the bone lengthening device 200 includes an inner rod 202 housing a rotary actuator 204 configured to drive a lead screw 206, which is screw-engaged with a threaded inner surface 208b of an outer rod 208. As best seen in Figure 2, the mechanism for converting and securing rotational motion into linear motion, namely the lead screw 206, the threaded inner surface 208b of the outer rod 208, and the outer rod 208 surrounding the inner rod 202, are configured in "parallel" with respect to the rotary actuator 204 (see Figure 3D), thereby significantly reducing the overall length compared to devices with a series configuration known in the prior art. Preferably, the inner rod 202 and the outer rod 208 are made of surgical-grade stainless steel. In some embodiments, the inner rod 202 and the outer rod 208 may be tubular, but in other intended embodiments, the inner rod 202 and the outer rod 208 may have different configurations, provided that they are configured in a manner that allows rotational motion to be converted into relative linear motion.

[0021] There are significant differences between bone lengthening devices configured in "parallel" and those configured in "series." In the background art, in series-configured devices, the rotary actuator is located inside the outer rod and drives a lead screw by screw-engaging with the threaded inner surface of the inner rod. In contrast, in the present invention, the parallel-configured device is configured such that the rotary actuator is located inside the inner rod and drives a lead screw that screw-engages with the threaded inner surface of the outer rod. By housing the rotary actuator (and other components) in the inner tube, a device with a more compact length is obtained compared to the device of the background art.

[0022] As best seen in Figures 3A, 3B, 3C, and 3D, the implantable bone lengthening device 200 according to the present invention includes an inner rod 202, which is located within an internal cavity indicated by the letter "C", defined by the internal volume of an outer rod 208. The inner rod 202 is at least partially telescopically positioned within the internal cavity C of the outer rod 208 and preferably includes an end 202a, which partially protrudes from the outer rod 208, terminating at the opposite end 208a. The inner rod 202 is tubular and defines an internal volume that accommodates at least a rotary actuator 204. A lead screw 206 is located at the end of the inner rod 202 opposite to the end 202a and is rotatably coupled to the rotary actuator 204. The lead screw 206 is generally cylindrical and defines an outer peripheral surface 206a, which is a threaded outer surface configured to screw-engage with the threaded inner surface 208b of the outer rod 208 surrounding the internal cavity C. The threads of the lead screw 206 may have any suitable shape and dimensions, such as thread pitch, helix angle, thread angle, and crest / trough dimension, provided that the threads of the lead screw 206 reliably engage with the threads 208b formed on the inner surface (208b) of the outer rod 208. In some embodiments, the threads are metric triangular threads, which are ISO metric threads (part of the profile of a metric triangular thread, metric trapezoid, UTS profile). In some embodiments, the thread pitch is 0.4 mm, and in other embodiments, the thread pitch may vary, preferably in the range of 0.05 mm to 2.0 mm. Preferably, the bone lengthening device is manufactured to have a retracted total length of 120.0 mm, a diameter of 8.0 mm, a stroke length of 50 mm, and to be able to generate an axial force of 600 N. As is obvious, these dimensions can be changed without departing from the scope of the present invention.

[0023] The rotary actuator 204 drives the lead screw 206 to rotate relative to the inner rod 202. As will be further described herein, the outer rod 208 is restricted from rotating relative to the inner rod 202, but is otherwise free to move axially along the length of the inner rod 202. The operation of the rotary actuator 204 rotates the lead screw 206, thereby moving the outer rod 208 axially relative to the inner rod 202. Thus, the selective operation of the rotary actuator 204 lengthens the length of the implantable bone lengthening device 200 when the lead screw rotates in the first direction, and shortens the length of the implantable bone lengthening device 200 when the rotary actuator 204 rotates the screw 206 in the opposite direction.

[0024] In some embodiments, the rotary actuator 204 includes an electric motor configured to impart rotational motion to the lead screw 206 when activated by an electrical signal. In other embodiments, the rotary actuator 204 includes a cylindrical magnet (e.g., a magnetically actuated motor) configured to impart rotational motion to the lead screw 206 when actuated by an externally generated magnetic field. Furthermore, it is assumed that any suitable device for generating rotational motion of the lead screw 206 is within the scope of the present invention.

[0025] As shown in Figure 4, in some embodiments, the rotary actuator 204 may include an electric motor or a cylindrical magnet 204a, or any other suitable actuator device. In addition, the actuator assembly may further include a reducer 204b that couples the motor or magnet 204a to a lead screw 206. The reducer 204b functions to increase the torque of the rotary actuator (e.g., a small motor) to a desired torque that drives the lead screw 206 while maintaining an acceptable speed. In some embodiments, the reducer 204b includes a gear assembly or gearbox, such as a planetary gearbox. In some embodiments, the reducer 204b includes a strained wave gear reducer. In some embodiments, the reducer 204b includes a hypocycloidal reducer. In some embodiments, the reducer 204b includes any two of the planetary gear reducer, strained wave gear reducer, and / or hypocycloidal reducer. In some embodiments, the gearbox 204b includes all three: a planetary gear reducer, a distortion wave gear reducer, and / or a hypocycloidal gear reducer.

[0026] As best illustrated in Figure 5, the inner rod 202 may further house an electronics package 210, such as power supply electronics, sensors, motor drivers, and controllers. As further shown in Figure 6, the inner rod 202 may include a rotary actuator 204, the electronics package 210, and a power source 212. The power source 212 may include a battery, a primary battery, a radio power receiver, or any other suitable device capable of receiving and / or supplying power. In an alternative embodiment shown in Figure 7, power may be supplied to a device such as the electronics 210 housed within the inner rod 202 via a conductive cable 213 electrically connected to a portable remote power module 214. The remote power module 214 may include an energy storage device such as a battery or primary battery, and may further optionally include several electronic devices. In another assumed embodiment, the portable remote power module 214 may include a radio power receiver and, optionally, several electronic devices.

[0027] Referring to Figure 8, an embodiment of an implantable bone lengthening device 200 is disclosed. This further includes a bearing 216 that is operable when subjected to axial and / or radial forces. The bearing 216 withstands forces applied between the inner rod 202 and the lead screw 206 and allows rotational motion of the lead screw 206 relative to the inner rod 202. The bearing 216 further transmits axial and / or radial forces applied to the outer rod 208 via the lead screw 206 to the inner rod 202. The bearing 216 may include a thrust bearing, such as a thrust ball bearing, thrust roller bearing, tapered roller bearing, thrust needle bearing, or thrust plane bearing. In other conceivable embodiments, the bearing 216 may include a radial bearing, such as a radial ball bearing, radial roller bearing, radial needle bearing, or radial plane bearing. In other conceivable embodiments, the bearing 216 is an angular contact bearing, such as an angular contact ball bearing, an angular contact tapered roller bearing, or a plain angular contact bearing. In yet another conceivable embodiment, the bearing 216 may include a combination of one or more bearings, or a combination of one or more bearings and bearing types, such as a combination of multiple axial bearings, radial bearings, and angular contact bearings. Other bearings 216 may include single-row bearings, double-row bearings, or bearings configured for forces applied in one or more directions.

[0028] Figures 9A and 9B show yet another embodiment adapted with a seal 218. The seal 218 functions to seal the device so that biocompatible components that can come into direct contact with patient tissue are separated by the seal 218 from non-biocompatible components that must be isolated from patient tissue. The seal 218 may be used in combination with one or more bearing configurations disclosed herein. Figure 9A shows the use of a seal 218 positioned adjacent to the lead screw 206 between the output shaft and the inner rod 202 of a rotary actuator 204. Figure 9B shows the use of a seal 218 positioned between the inner rod 202 and the outer rod 208, close to the protruding end of the inner rod 202. The seal 218 may include an O-ring, or may consist of one or essentially consist of one. In other conceivable embodiments, the seal 218 includes an X-ring, or may consist of one or essentially consist of one. In yet another embodiment, the seal 218 includes, or is composed of, or is essentially composed of, an O-ring, X-ring, V-ring, Leap seal, or other form of seal.

[0029] Referring here to Figure 10, the outer rod 208 may be adapted to include a vent 220, which allows the internal cavity C to fluidly communicate with the environment outside the outer rod 208. The vent 220 operates to prevent a pressure difference (e.g., reduced pressure or vacuum) from forming across the wall of the outer rod 208 as the outer rod advances axially along the inner rod 202, as the internal cavity C expands. The vent 220 may also allow the internal cavity C to be filled with air or gas during implantation. The vent 220 may be formed by a through bore and may further include fluid communication through a channel formed in the outer rod 208.

[0030] As shown in Figures 11 and 12A to 12C, the implantable bone lengthening device may be configured such that the outer diameter of the protruding end 202a of the inner rod 202 is approximately the same as, or the same as, or greater than the outer diameter of the outer rod 208. In those embodiments, as shown in Figures 12A to 12C, a sleeve 222 may extend from the end 202a of the inner rod 202 over the outer rod 208 to prevent tissue growth in the gap G formed between the end 202a and the outer rod 208 as the outer rod 208 moves axially along the inner rod 202. The sleeve 222 may be made of surgical-grade steel or any other suitable material, and the outer rod slides freely within the sleeve or sheath.

[0031] In the embodiment shown in Figure 13, the bushing 224 is positioned within the outer rod 208, close to the protruding end 202a of the inner rod 202. The bushing 224 functions to ensure proper alignment between the inner rod 202 and the outer rod 208 and to reduce or minimize play between the inner rod 202 and the outer rod 208. Furthermore, the bushing 224 functions to reduce friction between the components and to ensure smooth sliding of the outer rod 208 on the inner rod 202.

[0032] Referring now to Figure 14, the projection 202a of the inner rod 202 may include a filleted end profile F to reduce or minimize abrasion damage to the tissue surrounding the implantable bone lengthening device 200. The end 208a of the outer rod 208 may further include a filleted end profile F' to reduce or minimize abrasion damage to the tissue surrounding the implantable bone lengthening device 200.

[0033] Figure 15 is a detailed partial cross-sectional view showing the sliding engagement between the inner rod 202 and the outer rod 208. The threads formed on the inner surface of the outer rod 208 slide-engage with the overall smooth outer surface of the inner rod 202 to allow the outer rod 208 to slide properly on the inner rod 202. The inner rod 202 and the outer rod 208 are formed to precise tolerances to maximize the balance between friction and play. In some embodiments, the lead screw 206 includes the shape of a metric triangular screw, which is an ISO metric screw. In some embodiments, the outer rod 208 includes a portion of the shape of a metric triangular screw, which is an ISO metric screw.

[0034] Figures 16A, 16B, and 17 illustrate embodiments of a bone lengthening device adapted to the present invention, with opposite ends to facilitate attachment of the device to bone. Referring to Figure 16A, the bone lengthening device 200 has an inner rod end 202a and an outer rod end 208a, each defining a through bore 226. The through bore 226 is supplied with bone screws, or other suitable fasteners or attachment devices, for attaching the opposite ends of the bone lengthening device 200 to the corresponding portions of bone. Figure 16B illustrates an alternative embodiment in which the inner rod end 202a and the outer rod end 208a each define a pair of longitudinally aligned through bores 226, each intended and supplied to receive bone screws, or other suitable fasteners or attachment devices, for attaching the opposite ends of the bone lengthening device 200 to the corresponding portions of bone. Figure 17 shows yet another embodiment in which the inner rod 202 and the outer rod 208 are fitted with a lateral fixing plate 228, and a pair of through bores 226 are defined in each of the lateral fixing plates 228. As is clear, the inner rod 202 and the outer rod 208 may include various through bore and fixing plate configurations. Furthermore, the through bores may be axially aligned or axially offset, and may be arranged at various aligned or unaligned angles.

[0035] Referring here to Figures 18A and 18B, one advantage of the bone lengthening device 200 according to the present invention is illustrated. In the comparative diagrams shown in Figures 18A and 18B, the bone lengthening device 200 according to the present invention has a minimum (e.g., fully retracted) length L2 that is significantly shorter than the minimum (e.g., fully retracted) length L1 of the bone lengthening device 100 corresponding to the background art. This, however, has the same stroke length S and guide length G. The shorter retracted overall length is important because it allows the bone lengthening device 200 of the present invention to be used on smaller bones, which are present when treating pediatric patient cases.

[0036] Figures 19A and 19B illustrate another advantage of the bone lengthening device 200. In these comparison figures, the stroke length S2 of the bone lengthening device 200 according to the present invention is significantly longer than the stroke length S1 of the bone lengthening device 100 of the background art, which has the same minimum (e.g., retracted) length L and the same guide length G.

[0037] Figures 20A and 20B illustrate another advantage of the bone lengthening device 200 according to the present invention. In these comparison figures, the guide length G2 of the bone lengthening device 200 conforming to the present disclosure is significantly longer than the guide length G1 of the bone lengthening device 100 of the background art, which has the same minimum (e.g., retracted) length L and the same stroke length S.

[0038] Figures 21A and 21B illustrate yet another advantage of the bone lengthening device 200 of the present disclosure. In this comparison, the space 204' available for the rotary actuator in the bone lengthening device 200 of the present disclosure (Figure 21B) is substantially larger than the space 104' available for the actuator in the prior art system (Figure 21A).

[0039] Figure 22 shows the bone lengthening device 200 of the present disclosure used as an intramedullary lengthening device. Referring to Figure 23, the bone lengthening device 200 of the present disclosure may be used as an extramedullary lengthening device. Referring to Figure 24, when used as an extramedullary lengthening device, the bone lengthening device 200 of the present disclosure may be associated with an intramedullary reinforcement 40. Referring to Figure 25, the bone lengthening device 200 of the present disclosure may be used as a lengthening plate. In some embodiments, the implantable bone lengthening device 200 is an intramedullary retrograde nail, and in other embodiments, the implantable bone lengthening device is an intramedullary anterograde nail.

[0040] In the case represented by Figure 26, the implantable bone lengthening device 200 is powered by an integrated power supply as disclosed above and communicates wirelessly with an external control unit 300. Wireless communication may include transmitting signals externally and / or transmitting signals from the control unit 300 or any other electronic monitoring and / or control device. Furthermore, wireless communication may include the device 200 receiving signals transmitted from the external control unit 300 or any other electronic monitoring and / or control device. Figure 27 shows the implantable bone lengthening device 200 receiving power using an integrated power receiver as disclosed above, thereby the device 200 is wirelessly powered by the external control unit 300 and communicates wirelessly with the external control unit 300. According to this embodiment, power is wirelessly transmitted to the device 200 via the external control unit 300. Figure 28 shows an embodiment in which the implantable bone lengthening device 200 is powered by a remote power supply module 214 (with power storage and / or battery power supply) and communicates wirelessly with the external control unit 300. In the case shown in Figure 29, the implantable bone lengthening device 200 is powered by a remote power supply module 214 equipped with a power receiver that wirelessly receives energy from an external control unit 300, thereby enabling electrical energy to be supplied to the device 200 via a conductive cable 213. This embodiment further includes (a) a wired communication function between the device 200 and the module 214, and (b) a wireless communication function between the module 214 and the external control unit 300. The present invention further assumes that the cable 213 may further include at least a portion thereof configured as a wireless communication antenna. As is obvious, the control unit 300 supplies a signal to the implantable bone lengthening device 200 (e.g., a rotary actuator 204) to rotate the lead screw 206. In some embodiments, the signal contains enough information to cause the rotary actuator 204 to rotate the lead screw 206 by a predetermined amount (e.g., a predetermined degree of rotation of the lead screw 206, a predetermined axial movement of the outer rod 208, a predetermined torque, or a predetermined force). In some embodiments, the signal includes a power component such as a voltage wave or some alternating current wave.

[0041] Figures 30A and 30B are cross-sectional views of the bone lengthening device 200 according to the present invention, showing the device in a retracted configuration and an extended configuration, respectively, and further showing a 50.0 mm movement between the retracted and extended configurations. Figures 31A and 31B are cross-sectional perspective views showing the bone lengthening device 200 in a retracted configuration and an extended configuration. The bone lengthening device 200 includes an inner rod 202 and an outer rod 208 arranged in a retractable relationship. The inner rod 202 houses an actuation assembly 204, which includes a motor 204a that drives a gearbox 204b, and the gearbox 204b drives a lead screw 206. A bearing 216 and a seal 218 are located between the gearbox 204b and the lead screw 206. The inner rod 202 further houses an electronics package 210 that electronically communicates with a motor 204a via an electrical connection on one side, and a sensor 230 (force sensor 230) via an electrical connection on the opposite side. The sensor 230 functions to detect and measure axial forces applied to the bone lengthening device 200. The device 200 further includes a proximal axial stop 232 and an anterior axial stop 234. The proximal axial stop 232 functions to close the proximal end of the device and hold axial tensile forces. For example, when a surgeon applies a tensile force to the end 202a of the inner rod 202, the force is transmitted to the outer rod 208 via the lead screw 206, the bearing 216, and the axial stop 232. The forward axial stop 234 is associated with the sensor 230. Figure 32 is an exploded perspective view of the bone lengthening device according to the present invention.

[0042] In intended alternative embodiments, the implantable bone lengthening device may further include a vibration sensor configured to detect vibration patterns linked to callus stiffness and / or the performance of the implantable bone lengthening device.

[0043] Next, looking at Figure 33, a structure that restricts rotational movement between the inner and outer rods is depicted. Specifically, the outer surface of the inner rod 202 defines one or more radially outward projecting lugs, indicated by reference numeral 240, which are arranged longitudinally. The inner surface of the outer rod 208 defines one or more radially inward projecting channels, indicated by reference numeral 242, which are arranged longitudinally. The lugs 240 are received into the channels 242 when the inner rod 202 is operatively engaged with the outer rod 208. Figure 34 is a cross-sectional view showing the inner rod 202 positioned within the outer rod 208, with the lugs 240 slidably received into the channels 242. As is evident from the fact that the lugs 240 are received into the channels 242, the inner rod 202 and the outer rod 208 are able to expand and contract longitudinally while being prevented from rotating relative to each other. Figure 35 is an additional longitudinal cross-sectional view of the device showing the lugs 240 of the inner rod. The lugs 240 and channels 242 may extend substantially along the entire length of the device 200, may extend only partially, and may be formed continuously in spaced segments. Figure 36A is a cross-sectional view obtained along line 36A-36A of Figure 35, illustrating the channels 242 formed on the partially threaded inner surface of the outer rod 208. Figure 36B is a cross-sectional view obtained along line 36B-36B of Figure 35, illustrating the partially threaded inner surface of the outer rod 208. Figure 37A illustrates through bores 226 located at opposite ends of the device 200, the through bores being spaced longitudinally and aligned axially in parallel, and Figure 37B is a perspective view thereof. Figure 38A is a side view showing an alternative through bore configuration in which the through bores at opposite ends of the device 200 are spaced longitudinally and their axes are angularly offset, and Figure 38B is a perspective view thereof. Figure 39 is a side view showing a through bore composed of vertical and oblique angles.

[0044] Figure 40A is a side section view highlighting the proximal axial stop 232 and the distal axial stop 234 (proximal axial stop), and Figure 40B is a perspective cross view thereof. Figure 41 shows the configuration of an alternative embodiment of the bone lengthening device, indicated overall by reference numeral 30. The bone lengthening device 30 of the alternative embodiment has substantially the same components and functions as the bone lengthening device 200, but further includes longitudinally positioned protruding flanges indicated by reference numeral 302. Each flange 302 defines one or more through bores 304 that function to receive fasteners or sutures (not shown) for fixing the device 30 to the bone.

[0045] [Methods for lengthening bones] An implantable bone lengthening device 200 conforming to this disclosure may be used to lengthen the bone of a subject in need, such as a pediatric patient case. Overall, a method for lengthening the bone of a subject in need comprises: associating (e.g., implanting) the implantable bone lengthening device 200 disclosed herein with the bone of a subject in need of lengthening; activating the rotary actuator 204a of the implantable bone lengthening device 200 to lengthen the implantable bone lengthening device 200; waiting for a period of time until bone formation (e.g., callus bone) occurs; and repeating the activation and waiting steps until the bone is lengthened to a desired amount. In some embodiments, the method further comprises removing the implantable bone lengthening device 200 from the subject after the bone has been lengthened to a desired amount.

[0046] In some embodiments, the step of associating the implantable bone lengthening device 200 includes inserting the bone lengthening device 200 into the medullary cavity of the bone. In some embodiments, the medullary cavity is expanded (e.g., perforated) to accommodate the diameter and / or length of the implantable bone lengthening device 200. The step of associating (e.g., implanting) the implantable bone lengthening device 200 may further include, for example, anchoring the inner rod 202 to the bone by one or more bone screws, bone anchors, and / or sutures, and anchoring the outer rod 208 to the bone by one or more bone screws, bone anchors, and / or sutures. In some embodiments, the step of anchoring the inner rod 202 to the bone includes driving one or more bone screws through one or more holes 226. In some embodiments, the step of anchoring the inner rod 202 to the bone includes driving two or more bone screws through holes 226 that penetrate a lateral fixation plate 228 associated with the inner rod 202. In some embodiments, the step of anchoring the outer rod 208 to the bone includes driving one or more bone screws through one or more holes 226 in the outer rod 208. In other embodiments, the step of anchoring the outer rod 208 to the bone includes driving two or more bone screws through holes 226 that penetrate a lateral fixation plate 228 associated with the outer rod 208.

[0047] As shown in Figure 22, the step of associating the implantable bone lengthening device 200 with bone B may include inserting the implantable bone lengthening device 200 into the medullary cavity of bone B. In other embodiments, in an embodiment that fits Figure 23, the step of associating the implantable bone lengthening device 200 with bone B includes attaching the implantable bone lengthening device 200 to the outer surface (e.g., cortical surface) of bone B. In such embodiments, a bone screw or threaded suture (not shown) is driven or passed through a through bore 226 of the inner rod 202 by driving the bone screw or threaded suture through a hole 226 of the outer rod 208, for example, using the embodiment depicted in Figure 17 described earlier.

[0048] As shown in the embodiment depicted in Figure 24, in the extramedullary configuration of the device 200, a reinforcing member 40 may be placed intramedullarily and associated with bone B to provide stabilization and rigidity. To further stabilize bone B by reducing or eliminating the risk of bone B bending along its length, the reinforcing member 40 is given size, shape, and associated with bone B. In some embodiments, the method further comprises performing a cortical incision and / or osteotomy on the bone before associating the implantable bone lengthening device 200 with the bone.

[0049] The step of activating the rotary actuator 204 includes, for example, sending an electrical signal from the control unit 300 to the rotary actuator 204 so that the lead screw 206 extends the outer rod 208 relative to the inner rod 202 by a predetermined distance. The predetermined distance may be 0.01 mm to 2.0 mm, but it is assumed that any suitable distance falls within the scope of the present invention. In some embodiments, the step of activating the rotary actuator 204 includes, for example, sending an electrical signal from the control unit 300 to the rotary actuator 204 so that the lead screw 206 extends the outer rod 208 relative to the inner rod 202 by a predetermined force. The predetermined force may be 1 N to 3000 N. In some embodiments, the step of activating the rotary actuator 204 includes, for example, sending an electrical signal from the control unit 300 to the rotary actuator 204 so that the lead screw 206 extends the outer rod 208 relative to the inner rod 202 by a derivative of a predetermined force. The predetermined force fluctuation (i.e., derivative) may be between 4 N / mm and 50,000 N / m. This step of operating the rotary actuator to extend the outer rod 208 by a predetermined distance or to apply a predetermined force is preferably repeated sequentially in a predetermined manner.

[0050] In some embodiments, the step of activating the rotary actuator 204 includes sending an electrical distraction signal from the control unit 300 to the rotary actuator 204. The distraction signal causes the lead screw 206 to extend the outer rod 208 by a predetermined combination of distance, force, and force variation. In some embodiments, the predetermined distance, force, and force variation can be achieved at a predetermined speed or time, or at a maximum / minimum speed or time. In some embodiments, the step of waiting for a period of time to allow callus bone formation includes waiting from a few seconds to a few hours or a few days. In some embodiments, the step of activating the rotary actuator and the step of waiting for a period of time to allow callus bone formation are performed together to distract the bone by about 0.25 mm to about 2 mm per day. The step of activating the rotary actuator and the step of waiting for a period of time are repeated until the bone is extended by the desired amount. The desired amount of extension varies depending on the subject (patient) and the bone.

[0051] In some embodiments, the present disclosure provides a method for lengthening bone B in a subject (patient case) that requires it, namely, (a) The step of associating the implantable bone lengthening device 200 disclosed herein with the target bone B, (b) The step of operating the rotary actuator 204 to advance the outer rod 208 relative to the inner rod 202 by a predetermined distance, force, derivative of force, velocity and / or time, (c) A step of waiting for a certain period of time to allow callus bone formation, (d) The step of repeating steps (b) and (c) until bone B is extended to a desired length. In some embodiments, the method further comprises forming or expanding the medullary cavity in the bone prior to the step of associating the implantable bone lengthening device 200 with bone B. In some embodiments, the method further comprises associating a reinforcing material 40 with bone B to further stabilize bone B. In some embodiments, the step of associating the implantable bone lengthening device 200 with bone B includes inserting the implantable bone lengthening device 200 into the medullary cavity of bone B. In some embodiments, the step of associating the implantable bone lengthening device 200 with bone B includes attaching the implantable bone lengthening device 200 to the outer surface of bone B. In some embodiments, the subjects are pediatric patient cases. In some embodiments, bone B is a bone of the lower limb, and bone B is a bone of the upper limb.

[0052] The present invention relates to a device for correcting spinal curvature of the spine, comprising an inner rod and a tubular outer rod completely isolated beneath the skin, and mounting screws for connecting the inner rod and the tubular outer rod to the spine, wherein the end of the inner rod is connected to a first vertebra and the opposite end of the outer rod is connected to a second vertebra. The present invention includes embodiments of the device. The device further comprises a rotary actuator housed within the inner rod, which, under external control, extends the device longitudinally over a specified extended period until a desired spinal curve is obtained. Otherwise, the invention is as generally described above in this specification. The device is combined with an external or portable power supply. In one embodiment, the device further comprises a link with sensor means enabling measurement of driving force and / or extension vector, as disclosed herein. In one embodiment, the sensor means comprises at least one strain gauge for force measurement. In one embodiment, the sensor means comprises at least one accelerometer for displacement measurement. More generally, the present invention is characterized as a combination of a tubular outer rod, an inner rod, a mounting screw, and a rotary actuator housed in the inner rod, wherein the lead screw is rotatably coupled to the rotary actuator, the lead screw, screw-engaged with the threaded inner surface of the outer rod, generates a force over a specified period of time until the spine, to which a steady force is applied, is at least partially straightened.

[0053] Figure 42 relates to one embodiment and shows a bone lengthening device 200 fixed to the spine, indicated by the letter "S", within the patient's body, indicated by the letter "BD". An external control and telemetry unit, indicated by the letter 400, is located outside the patient's body and functions to control a rotary actuator and to communicate wirelessly with sensors associated with the device 200. The sensors associated with the bone lengthening device 200 are preferably integrated into the device 200 and can provide the surgeon (clinical staff) with key information related to the device 200 and its environment. The key information includes bone lengthening stroke, spinal deformity correction (angle, length, vector, etc.), device temperature, stiffness of regenerated bone, strain applied to the device 200, and strain applied to the spine "S". One embodiment of the present invention includes the ability of the surgeon to update the patient protocol by taking into account key information data from the device 200 and its environment, and by the spinal curvature and its correction. In practice, the surgeon modifies the relevant parameters defined in software incorporated into the telemetry unit 400. The remote measurement unit 400 transmits updated control / commands to the actuator device 200. A remote power supply unit 214, such as a battery, supplies power to the device 200. In a preferred embodiment, the control and remote measurement unit 400 communicates with the bone lengthening device 200 by wireless communication, such as Bluetooth® low-energy technology.

[0054] Figure 43 relates to another embodiment and shows a pair of bone lengthening devices, indicated as 200A and 200B, fixed to the patient's spine "S". As disclosed above, an external control and telemetry unit, indicated by reference numeral 400, is located outside the patient's body and functions to control a rotary actuator and to communicate wirelessly with sensors associated with the device 200. The sensors associated with the bone lengthening device 200 are preferably integrated into the device 200 and can provide the surgeon with key information related to the device 200 and its environment. Key information includes bone lengthening stroke, spinal deformity correction (angle, length, vector, etc.), device temperature, stiffness of regenerated bone, strain applied to the device 200, and strain applied to the spine "S". One embodiment of the present invention includes the ability of the surgeon to update the patient protocol by spinal curvature and its correction after taking into account key information data from the device 200 and its environment. In practice, the surgeon modifies the relevant parameters defined in software incorporated into the telemetry unit 400. The telemetry unit 400 transmits the updated control / command to the actuator device 200. A single remote power unit 214, such as a battery, supplies power to both devices 200A and 200B. In a preferred embodiment, a control and telemetry unit 400 communicates with the bone lengthening device 200 by wireless communication, such as Bluetooth® low-energy technology.

[0055] The foregoing description relating to specific embodiments of the present invention is provided for illustrative and explanatory purposes only. It is not intended to be exhaustive or to limit the invention to the exact form disclosed. In light of the above teachings, it will be apparent that many modifications and variations are possible. The embodiments have been selected and described to best illustrate the principles and practical applications of the present invention, thereby enabling those skilled in the art to best utilize the invention and its various embodiments with various modifications to suit specific intended uses. The scope of the present invention is intended to be defined by the appended claims and their equivalents.

[0056] It should be understood that the foregoing descriptions are illustrative and descriptive only and do not limit the methods and devices described herein. In this application, the use of the singular includes the plural unless otherwise specified. All patents, patent applications, publications and references cited herein are expressly incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0057] The present invention may have the following additional features. That is, [Additional note 1] An inner rod having an outer surface, An outer rod that is retractably engaged with the inner rod, the outer rod having a threaded inner surface that is axially slidably engaged with the outer surface of the inner rod, The inner rod and the outer rod each have ends configured to be attached to a bone, A rotary actuator housed within the aforementioned inner rod, The lead screw is axially aligned with the rotary actuator and rotatably coupled to it, and comprises a lead screw that screw-engages with the threaded inner surface of the outer rod, This converts the rotational motion of the rotary actuator into linear motion, resulting in a change in the axial length of the bone lengthening device. It may be a transplantable bone lengthening device. [Additional note 2] The rotary actuator may be an implantable bone lengthening device as described in Appendix 1, including an electric motor. [Additional note 3] The rotational actuator may be an implantable bone lengthening device as described in Appendix 1, which includes a non-electric actuator that operates in response to an externally generated magnetic field. [Additional note 4] The rotary actuator may further be an implantable bone lengthening device as described in Appendix 1, including a reduction gear. [Additional note 5] Furthermore, the implantable bone lengthening device according to Appendix 1 may further include an electronic equipment package housed within the inner rod. [Additional note 6] The aforementioned electronic equipment package may be an implantable bone lengthening device as described in Appendix 5, including a power supply. [Additional note 7] Furthermore, the implantable bone lengthening device according to Appendix 1 may include a force sensor configured to detect an axial force applied to the bone lengthening device. [Additional note 8] The inner rod may further include an externally positioned sleeve, which may be an implantable bone lengthening device as described in Appendix 1, extending from the end of the inner rod. [Additional note 9] The inner rod further includes an externally positioned sleeve, which may be an implantable bone lengthening device as described in any one of appendices 2 to 7, extending from the end of the inner rod. [Additional Note 10] The bone may be a transplantable bone lengthening device as described in Appendix 1, including the first and second vertebrae. [Additional Note 11] An internal rod that defines the internal volume, The outer rod engages with the inner rod in an extendable and retractable manner, and comprises an outer rod that defines an internal cavity surrounded by a threaded inner surface, The inner rod and the outer rod each have ends configured to be attached to a bone, An electronic device package located within the aforementioned internal volume, A rotary actuator that electrically communicates with the aforementioned electronic device package, comprising a motor and a gear assembly, A lead screw coupled to the output portion of the gear assembly, having a threaded outer surface that is arranged to screw-engage with the threaded inner surface of the outer rod, The device comprises means for operating the rotary actuator to selectively extend or retract the bone lengthening device. It may be a transplantable bone lengthening device. [Additional Note 12] The means for activation may be an implantable bone lengthening device as described in Appendix 11, which includes an implantable remote power supply module that electrically communicates with the electronic equipment package. [Additional Note 13] The means for activation may be an implantable bone lengthening device as described in Appendix 11, including an external control unit adapted for wireless communication with the electronic equipment package. [Additional Note 14] The external control unit may further be an implantable bone lengthening device as described in Appendix 13, comprising means for transmitting power to the electronic equipment package. [Additional Note 15] The outer rod, the inner rod, the rotary actuator, and the lead screw may be configured in parallel, thereby enabling the mechanical configuration to convert rotational motion into linear motion, in the implantable bone lengthening device described in Appendix 11. [Additional Note 16] An implantable device for treating spinal curvature of the target spine, The inner rod and A tubular outer rod that is retractably engaged with the inner rod, and the outer rod has a threaded inner surface that is axially slidably engaged with the inner rod, The inner rod and the outer rod each have ends configured to be attached to a bone, A rotary actuator housed within the aforementioned inner rod, The lead screw is rotatably coupled to the rotary actuator and comprises a lead screw that is screw-engaged with the threaded inner surface of the outer rod, As a result, the rotational motion of the rotary actuator is converted into linear motion, which in turn causes a change in the overall length of the device. The aforementioned bone includes the first vertebra and the second vertebra. It may be a portable device. [Additional Note 17] A first inner rod and an outer rod, each having ends configured to be attached to at least two vertebrae, The implantable device may be the one described in Appendix 16, comprising a second medial rod and a second lateral rod, each having ends configured to be attached to at least two vertebrae. [Additional Note 18] Furthermore, the portable device may be one of those described in Appendix 17, comprising a single power supply unit for supplying power. [Additional Note 19] A method for collecting and transmitting multiple physiological data from an implantable bone lengthening device in cooperation with a control and remote measurement unit, To begin the collection process, the first step is to start at least one command, A step of inquiring about the implantable bone lengthening device, The steps include collecting multiple physiological data, The method may include the step of transmitting data to a patient file. [Additional Note 20] A method for updating a patient protocol in cooperation with a control and remote measurement unit and remotely applying the patient protocol to an implantable bone lengthening device, The steps include changing the parameters recorded by the control and remote measurement unit, The steps include: initiating at least one command to activate the modified parameter, A step of transmitting updated instructions to an implantable bone lengthening device, The method may include the step of performing, in accordance with the updated patient protocol, an implantable bone lengthening device as described in Appendix 17, wherein the bone lengthening device further includes a single power supply unit for supplying power. [Additional Note 21] The updated patient protocol may be initiated by a surgeon in accordance with patient data recorded by a sensor linked to the implantable bone lengthening device, as described in Appendix 20.

Claims

1. An inner rod having an outer surface, An outer rod that is retractably engaged with the inner rod, the outer rod having a threaded inner surface that is axially slidably engaged with the outer surface of the inner rod, The inner rod and the outer rod each have ends configured to be attached to a bone, A rotary actuator housed within the aforementioned inner rod, The lead screw is axially aligned with the rotary actuator and rotatably coupled to it, and comprises a lead screw that screw-engages with the threaded inner surface of the outer rod, As a result, the rotational motion of the rotary actuator is converted into linear motion, which in turn causes a change in the axial length of the bone lengthening device. An external control unit is used that generates a wireless signal suitable for the operation of the rotary actuator. Furthermore, it includes a wireless interface means configured to receive the wireless signal via a communication connection with the external control unit and control the rotary actuator based on this signal. A transplantable bone lengthening device.

2. The implantable bone lengthening device according to claim 1, wherein the rotary actuator includes an electric motor.

3. The wireless interface means is arranged outside the inner rod, Furthermore, the implantable bone lengthening device according to claim 1, comprising a cable configured to connect the wireless interface means to the rotary actuator in the inner rod.

4. The implantable bone lengthening device according to claim 1, wherein the rotary actuator further includes a reduction gear.

5. Furthermore, the implantable bone lengthening device according to claim 1 comprises an electronic equipment package housed within the inner rod.

6. The implantable bone lengthening device according to claim 5, wherein the electronic equipment package includes a power supply.

7. Furthermore, the implantable bone lengthening device according to claim 1 is further equipped with a force sensor configured to detect an axial force applied to the bone lengthening device.

8. The implantable bone lengthening device according to claim 1, wherein the inner rod further includes an externally positioned sleeve, the sleeve extending from the end of the inner rod.

9. The implantable bone lengthening device according to claim 1, wherein the bone includes a first vertebra and a second vertebra.

10. The inner rod defines the internal volume, The outer rod defines an internal cavity surrounded by the threaded inner surface, Furthermore, it includes an electronic device package located within the internal volume, The rotary actuator electrically communicates with the electronic equipment package and includes a motor and a gear assembly. The lead screw is coupled to the output portion of the gear assembly and has a threaded outer surface that is arranged to screw-engage with the threaded inner surface of the outer rod. Furthermore, the device includes means for operating the rotary actuator to selectively extend or retract the bone lengthening device. The implantable bone lengthening device according to claim 1.

11. The implantable bone lengthening device according to claim 10, wherein the means for activating the device includes an implantable remote power module that electrically communicates with the electronic equipment package.

12. The implantable bone lengthening device according to claim 10, wherein the means for operating the device includes the external control unit adapted for wireless communication with the electronic device package via the wireless interface means.

13. The implantable bone lengthening device according to claim 12, wherein the external control unit further includes means for transmitting power to the electronic equipment package.

14. The implantable bone lengthening device according to claim 10, wherein the outer rod, the inner rod, the rotary actuator, and the lead screw are configured in parallel, so that the mechanical configuration converts rotational motion into linear motion.

15. The implantable bone lengthening device is an implantable device for treating spinal curvature of the spine of a target, The outer rod is a tubular outer rod, The aforementioned bone includes the first vertebra and the second vertebra. The implantable bone lengthening device according to claim 1.

16. A first inner rod and an outer rod, each having ends configured to be attached to at least two vertebrae, The implantable bone lengthening device according to claim 15, comprising a second inner rod and a second outer rod, each having an end configured to be attached to at least two vertebrae.

17. Furthermore, the implantable bone lengthening device according to claim 16 comprises a single power supply unit for supplying power.

18. A method for collecting and transmitting a plurality of physiological data from an implantable bone lengthening device according to claim 1, in cooperation with a control and remote measurement unit, To begin the collection process, there is a step of starting at least one command, A step of inquiring about the implantable bone lengthening device, The steps include collecting multiple physiological data, A method comprising the step of transmitting data to a patient file.

19. A method for updating a patient protocol in cooperation with a control and remote measurement unit and remotely applying the patient protocol to an implantable bone lengthening device, The steps include changing the parameters recorded by the control and remote measurement unit, The steps include: initiating at least one command to activate the modified parameter; A step of transmitting updated instructions to an implantable bone lengthening device, A method comprising the step of performing an implantable bone lengthening device according to claim 16, wherein the device further includes a single power supply unit for supplying power, in accordance with the updated patient protocol, the device further includes a single power supply unit for supplying power.

20. The method according to claim 19, wherein the updated patient protocol is initiated by a surgeon according to patient data recorded by a sensor means linked to the implantable bone lengthening device.

Images