JP-7855820-B2 - Bone lengthening device and method of use thereof

JP7855820B2JP 7855820 B2JP7855820 B2JP 7855820B2JP-7855820-B2

Inventors

シュバリエ，エリック
メルシェ，ウィリアム

Assignees

ニューヴェイジヴ，インコーポレイテッド

Dates

Publication Date: 20260511
Application Date: 20220525
Priority Date: 20210527

Claims (20)

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.
The implantable bone lengthening device according to claim 1, wherein the rotary actuator includes an electric motor.
The wireless interface means is located 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 .
The implantable bone lengthening device according to claim 1, further comprising a reduction gear for the rotary actuator.
Furthermore, the implantable bone lengthening device according to claim 1 comprises an electronic equipment package housed within the inner rod.
The implantable bone lengthening device according to claim 5, wherein the electronic equipment package includes a power supply.
Furthermore, the implantable bone lengthening device according to claim 1 comprises a force sensor configured to detect axial force applied to the bone lengthening device.
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.
The implantable bone lengthening device according to claim 1, wherein the bone includes a first vertebra and a second vertebra.
The aforementioned 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 .
The means for activation includes an implantable remote power module that electrically communicates with the electronic device package, according to claim 10, for the implantable bone lengthening device.
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.
The implantable bone lengthening device according to claim 12, further comprising means for transmitting power to the electronic equipment package from the external control unit.
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.
The implantable bone lengthening device is an implantable device for treating spinal curvature of the target spine , 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 .
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 .
Furthermore, the implantable bone lengthening device according to claim 16 comprises a single power supply unit for supplying power.
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.
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.
The updated patient protocol is initiated by a surgeon according to patient data recorded by a sensor linked to the implantable bone lengthening device, according to claim 19.

Description

This invention relates, in general, to a bone lengthening device, and more particularly to a compact bone lengthening device and method for use in lengthening the bones of pediatric patients and correcting scoliosis. Distraction osteoplasty is a surgical technique for lengthening bone. It consists of controlled osteotomy followed by the gradual, controlled traction of the two epiphyses using a mechanical device that applies tensile force to stimulate new bone growth. During the distraction phase, the distraction device pulls the two epiphyses at a specific speed and rhythm, typically 1.0 mm per day. Various distraction devices are known in the art. U.S. Patent Application Publication 2016/0058483 (Stauch) discloses a medullary pin for extending tubular bone, comprising a hollow body including first and second axially displaceable 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 the transmission of sensor signals from the device. U.S. Patent Application Publication 2011/0060336 (Pool) discloses an intramedullary extension device, comprising an actuator having a housing including a rotatable permanent magnet actuator, and a movable distraction shaft retractably mounted relative to the housing. The distraction shaft is operably coupled to the rotatable permanent magnet via a lead screw. U.S. Patent Application Publication 2017/0333080 (Roschak) discloses a remotely adjustable interactive bone reshaping implant. This system comprises an implant body, an actuator connected to the implant body, a sensor configured to detect parameters indicating biological status, a transceiver, and a controller. 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 allow spinal growth while preventing worsening of curvature. Traditionally, growth rod use required open-procedure distraction approximately every six months. Such open-procedure distractions carry a high risk of anesthesia and wound complications and are burdensome. Furthermore, repeated surgeries under general anesthesia can negatively impact brain development, which is particularly important for young children. The shortcomings associated with conventional growth rods (TGRs) have led to the development of alternative technologies from the background. 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 a desired spinal curve is achieved. U.S. Patent Application Publication No. 2015/0250505 (Inventor Ross) discloses a remotely controllable growth rod device comprising onboard electronics having a microprocessor configured to receive remotely transmitted motion data via a receiver, and further performing feedback-controlled operation of a drive assembly. Unlike TGR, the above techniques allow for distraction during outpatient visits, thus avoiding the risks of repeated surgical lengthening procedures. Furthermore, more frequent distractions may be possible 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 device miniaturization, personalized protocols, and improved postoperative care monitoring. While various devices known in this field are generally suitable for their intended 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 bac