EP4694807A1

EP4694807A1 - Motor module for motorizing a strut in a spatial frame

Info

Publication number: EP4694807A1
Application number: EP24722439.7A
Authority: EP
Inventors: Andrew P. NOBLETT; Jason LATHAM; Johnny R. MASON; Paul Bell
Original assignee: Smith and Nephew Orthopaedics AG; Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Current assignee: Smith and Nephew Orthopaedics AG; Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Priority date: 2023-04-14
Filing date: 2024-04-10
Publication date: 2026-02-18
Also published as: WO2024215706A1

Abstract

A motor module for use in a spatial frame is disclosed. Each of the motor modules being selectively attachable and detachable from a manually adjustable strut in a spatial frame. In use, with the motor modules detached, the struts can be manually adjusted to, for example, facilitate initial construction of the spatial frame in the operating room, to allow patients to manually adjust the struts if desired, etc. Thereafter, with the motor modules coupled to the struts, motorized and/or automated adjustment of the struts according to a treatment plan can be achieved. In use, each of the motor modules is configured to engage an actuation point positioned at the end of the manually adjustable struts.

Description

MOTOR MODULE FOR MOTORIZING A STRUT IN A SPATIAL FRAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a non-provisional of, and claims the benefit of the filing date of, pending U.S. provisional patent application number 63/459,392, filed April 14, 2023, entitled “Motor Module for Motorizing a Strut in a Spatial Frame,” the entirety of which application is incorporated by reference herein.

FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to orthopedic devices, systems, and methods for facilitating fracture alignment such as the treatment of musculoskeletal conditions with a spatial frame, and particularly to a motor module selectively attached and detached from a manually adjustable strut. In use, with the motor modules detached, the struts can be manually adjusted to change an overall length of the struts.

Alternatively, with the motor modules coupled to the struts, motorized and/or automated adjustment of the struts according to a treatment plan can be achieved.

BACKGROUND OF THE DISCLOSURE

[0003] People suffer bone fractures each year. In many instances, a person that suffers a bone fracture is required to use a bone alignment device, an external fixation system, etc. such as, for example, a spatial frame, a hexapod, etc. (terms used interchangeably herein without the intent to limit or distinguish) to align two or more bones, bone fragments, bone pieces, etc. (terms used interchangeably herein without the intent to limit or distinguish). Generally speaking, spatial frames allow for polyaxial movement of the coupled bones and are typically used to keep fractured bones stabilized and in alignment during a treatment period.

[0004] Generally speaking, the spatial frame includes first and second rings, platforms, frames, bases, etc. (terms used interchangeably herein without the intent to limit or distinguish) intercoupled by a plurality of struts. Tn use, the struts have adjustable lengths that may be manually adjusted regularly (e.g., daily) in accordance with a prescription or treatment plan (terms used interchangeably herein without the intent to limit or distinguish). As the lengths of the struts are adjusted, the platforms may be brought closer together or moved farther apart. The treatment plan specifies strut length adjustments to be made to each of the struts over time to ensure successful bone alignment. One known example of a spatial frame is the TAYLOR SPATIAL FRAME® manufactured and sold by Smith Nephew, Inc.

[0005] With reference to FIG. 1, another known example of a spatial frame 10 is illustrated. As shown in FIG. 1, the spatial frame 10 may include a metal frame with a first platform 20 and a second platform 30 connected by six adjustable length struts 40 (labeled as struts 40a through 40f in FIG. 1). Each strut 40 may be independently lengthened or shortened relative to the rest of the frame, thereby allowing for six different axes of movement.

[0006] Each strut 40 may include an outer body 42 and an inner body, which may be configured as, or be operatively coupled to, a threaded rod (also referred to as a lead screw 44). The outer body 42 may be coupled to one of the platforms, such as, the second platform 30 by way of a joint as shown. The lead screw 44 may be coupled to the other platform, such as, the first platform 20 by way of a joint as shown. In addition, each strut 40 may include an actuation point 46 such as, for example, a post containing a female Torx feature, a bolt, a nut, or any other suitable connection mechanism now known or hereafter developed. As shown, the actuation point 46 is located at an end of the strut 40. In use, the actuation point 46 is operatively coupled (either directly or indirectly) with the lead screw 44 so that rotation of the actuation point 46 rotates the lead screw 44. The lead screw 44 is rotatably coupled (either directly or indirectly) to the outer body 42 such as, for example, by incorporating internal threads, a nut, etc. into the outer body 42 for threadably engaging the lead screw 44. Thus arranged, with the outer body 42 coupled to the second platform 30 and rotatably coupled to the lead screw 44 rotation of the lead screw 44 alters an overall length of the strut 40.

[0007] In addition, as shown, in use, the actuation point 46 may extend through a hole or opening 22 formed in the first platform 20. Thus arranged, in use, the actuation point 46 is easily accessible by the end user or caregiver so that the end user or caregiver can engage and rotate the actuation point 46 to rotate the lead screw 44, which translates the lead screw 44 relative to the outer body 42 to lengthen or shorten one of struts 40 to adjust an overall length of the strut 40.

[0008] In use, the spatial frame 10 may be used to treat a variety of skeletal fractures of a patient. Typically, the spatial frame 10 is positioned around the patient and is used to align two or more bone portions. To do so, a length of each strut 40 may be incrementally adjusted (e.g., shortened or lengthened) in accordance with a treatment plan that specifies adjustments to be made to each strut 40 over time to ensure successful bone alignment. In many instances, the length of each strut 40 should be adjusted daily to comply with the provided treatment plan. Adjusting the length of each strut 40 adjusts the distance and/or position between the first and second platforms 20, 30, and hence the first and second bone portions coupled thereto.

[0009] During use, patient’s bones are normally adjusted (e.g., lengthened, shortened, etc.) manually, for example, by hand or a wrench at a rate of approximately 1 mm/day, which is then proceeded by a consolidation phase before the spatial frame is removed.

[0010] It is theoretically known in the prior art to automate and/or motorize adjustment of a spatial frame by motorizing or otherwise automating strut adjustments. For example, one known motorized spatial frame is the Robotic Hexapod System manufactured by Orthospin Ltd. In use, the Robotic Hexapod System includes an offset motor design that engages custom struts positioned between the first and second platforms. That is, the motor includes a first spur gear engaged with a second spur gear associated with the lead screw of the strut. In use, rotation from the motor drives rotation of the lead screw via the interaction between the spur gears. The Robotic Hexapod System however suffers from a number of disadvantages including being very bulky.

[0011] However, currently commercially available spatial frames are largely dependent on manual adjustment of each strut. As a result of the requirement for manual adjustments, generally speaking, successful treatment requires patient compliance (e.g., daily manual adjustments to each of the struts) to avoid human error. In routine clinical practice, the treatment plan may require multiple daily adjustments to be made to each of the plurality of struts. For example, a patient may be required to manually adjust one or more of the struts, typically two or more times each day, and often over long periods of time with support from either a family member, a clinician, or both. As such, compliance with the treatment plan may be burdensome, painful, and prone to errors, which may rise as the number of manual daily adjustment increases.

[0012] As a result, the number of adjustments dictated by the treatment plan may be limited. For example, generally speaking, treatment plans often limit the required number of daily adjustments to each of the plurality of struts to four per day. During a normal treatment plan, this may equate to approximately 720 adjustments (e.g., turns) over a one-month treatment span (e.g., 6 struts x 4 adjustments per day x 30 days).

During an extended treatment plan for more severe applications, this may equate to approximately 2,160 adjustments (e.g., turns) over a three-month treatment span (e.g., 6 struts x 4 adjustments per day x 90 days).

[0013] In addition, during the treatment period, the patient may require numerous clinical visits to confirm proper strut adjustments to ensure compliance and avoid incorrect adjustment, which has historically been the leading cause of treatment failure.

[0014] Motorized and/or automated spatial frames could provide numerous advantages over manually adjustable struts. In use, electric motors, motor-drive units, and one or more control units such as, for example, a central control unit or controller, could function to supersede the manual actuation of the strut adjustments. For example, an automated and/or motorized system could eliminate the need for patient compliance and decrease the frequency of post-operative visits for patient supervision given that the spatial frame may only need to be activated at the start of the distraction phase and terminated at the end of the distraction phase without any patient intervention. As a result, the burden of manual adjustment can be overcome by automating and/or motorizing the struts, which in turn, enables a more independent lifestyle during treatment.

[0015] In addition, automated and/or motorized spatial frames may allow the implementation of more diverse treatment schedules. For example, automated and/or motorized distraction could enable a higher distraction frequency and result in smaller excursions per activation. Smaller excursions or adjustments have the potential to result in less damage to the distracted tissues, improving bone regeneration and adaptation of the surrounding soft tissues. That is, spatial frames equipped with motorized and/or automated struts offer the potential to increase the number of daily distraction adjustments by enabling finer (e.g., smaller) adjustments at a controllable rate and frequency of distraction that encourages better quality bone formation. Making finer (e.g., smaller) adjustments during limb lengthening can have significant advantages in terms of reduced soft tissue damage, less pain, and opioid usage and accelerated bone healing. One study has found that the bone fixation index was only 5-6 days/cm when using motorized and/or automated distraction compared to 22-24 days/cm by manual adjustment.

[0016] For example, a motorized strut could be programmed to perform anywhere from one adjustment per day to continuous adjustments. Finer adjustments could increase the number of adjustments over a one-month period from approximately 720 adjustments to approximately 3,600 adjustments (e.g., 6 struts x 20 adjustments per day x 30 days). Alternatively, finer adjustments could increase the number of adjustments over a one-month period to approximately 259,200 adjustments (e.g., 6 struts x 1440 adjustments per day x 30 days). Over an extended three-month treatment period, this could increase the number of adjustments from approximately 2,160 adjustments to approximately 10,800 adjustments (e.g., 6 struts x 20 adjustments per day x 90 days). Alternatively, finer adjustments could increase the number of adjustments over a three- month period to approximately 777,600 adjustments (e.g., 6 struts x 1440 adjustments per day x 90 days).

[0017] In use, each strut 40 may be made to include, or be operatively coupled to or associated with, a motor and may be used in a spatial frame such as, for example, spatial frame 10, to move the first and second platforms 20, 30, respectively, to align two or more bone portions. In use, actuation of the motor may rotate the lead screw 44, which moves the lead screw 44 relative to the outer body 42 to adjust an overall length of the strut 40.

[0018] In addition, in use, the spatial frame and/or system architecture may be arranged and configured to automatically adjust the motorized struts according to the prescribed treatment plan (e.g., automatically adjust the plurality of motorized struts without patient intervention). Alternatively, the spatial frame and/or system architecture may be arranged and configured to require patient and/or caregiver activation to begin the process of automatically adjusting the motorized struts according to the prescribed treatment plan. For example, the spatial frame may be arranged to intermittently autoadjust the motorized struts at predetermined times according to the treatment plan. Alternatively, the spatial frame may be arranged to intermittently auto-adjust the motorized struts at select times when convenient and/or selected by the patient. Alternatively, the spatial frame may be arranged and configured to continuously autoadjust the motorized struts in small discrete increments.

[0019] It is with respect to these and other considerations that the present disclosure may be useful.

SUMMARY OF THE DISCLOSURE

[0020] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0021] A motor module arranged and configured to be used in a spatial frame is disclosed. In some examples, the spatial frame includes a plurality of manually adjustable struts coupled to first and second platforms. In use, movement of the struts move the first and second platforms, and hence the first and second bone portions coupled thereto. In any preceding or subsequent example, the struts include an outer body, an inner body, which may be in the form of a threaded rod or lead screw, and an actuation point located at an end of the strut. In use, rotation of the actuation point causes the lead screw to move relative to the outer body to adjust an overall length of the strut. [0022] In accordance with one or more features of the present disclosure, in any preceding or subsequent example, the motor modules are arranged and configured to be selectively attached to and detached from the plurality of manually adjustable struts. In use, with the motor modules detached from the manually adjustable struts, the struts can be manually adjusted to, for example, facilitate initial construction of the spatial frame in the operating room, to allow patients to manually adjust the struts if desired, etc. Thereafter, with the motor modules coupled to the struts, motorized and/or automated adjustment of the struts according to a treatment plan can be achieved.

[0023] In any preceding or subsequent example, each of the motor modules includes a motor having an output shaft and a torque transmitting mechanism arranged and configured to interact with the actuation point of the manually adjustable struts. For example, each of the motor modules may include a gear such as, for example, a spur or pinon gear, arranged and configured to engage a corresponding gear associated with the actuation point on the manually adjustable strut so that, in use, activation of the motor rotates the gear on the output shaft of the motor, which rotates the gear associated with the actuation point of the strut, which is associated with the lead screw of the strut to facilitate motorized and/or automated adjustment of the struts.

[0024] Alternatively, in various examples, the motor of the motor module may be associated with a worm gear to drive the gear of the actuation point of the strut. For example, the output shaft of the motor includes, or is formed in, a worm gear. In use, activation of the motor rotates the worm gear, which rotates the gear associated with the actuation point of the shaft, which rotates the lead screw of the strut. [0025] In any preceding or subsequent example, each of the motor modules may include a wireless communication chip arranged and configured to communicate with an external computing system to, for example, exchange data relating to strut position, exchange data relating to and updating the prescribed treatment plan, and exchange data related to the progression of bone healing and frame alignment, etc.

[0026] In any preceding or subsequent example, each motor module may include a self-contained microprocessor, which can receive and update the treatment plan as needed. In addition, the microprocessor is configured to control operation of the motor modules, and hence the struts, without the need for a separate centralized control unit positioned within the spatial frame (e.g., coupled to one of the platforms).

[0027] In any preceding or subsequent example, each of the motor modules may include a power supply such as, for example, a battery to power the motor module including, for example, the motor and any other circuity contained therein.

[0028] Alternatively, in various examples, each of the motor modules may be communicatively coupled, either directly or indirectly, to a central controller, which is arranged and configured to transmit power and data to each of the plurality of motor modules.

[0029] In some examples, a spatial frame is disclosed. The spatial frame including a first platform, a second platform spaced from the first platform, a plurality of adjustable length struts, each of the plurality of adjustable length struts coupled to the first platform and the second platform, each of the adjustable length struts including a body and a lead screw, wherein the lead screw is arranged and configured to move relative to the body to adjust a length of the strut, each of the struts including an actuation point located at an end thereof, and a plurality of motor modules, each of the plurality of motor modules being arranged and configured to couple to one of the first and second platforms and to one of the actuation points of one of the plurality of adjustable length struts, wherein each of the plurality of motor modules is arranged and configured to actuate motorized rotation of the actuation point to adjust the length of the strut to which it is coupled.

[0030] In any preceding or subsequent example, the first platform includes a plurality of holes formed therein, the actuation point extending through one of the plurality of holes formed in the first platform.

[0031] In any preceding or subsequent example, each of the plurality of motor modules includes a housing, a motor at least partially disposed within the housing, and a coupling mechanism arranged and configured to engage the first platform.

[0032] In any preceding or subsequent example, the coupling mechanism includes one or more cylinders arranged and configured to be received within one or more of the holes formed in the first platform.

[0033] In any preceding or subsequent example, the one or more cylinders include first and second cylinders configured to be positioned within first and second holes formed in the first platform. [0034] In any preceding or subsequent example, the first and second holes formed in the first platform for receiving the first and second cylinders are positioned on either side of the hole for receiving the actuation point.

[0035] In any preceding or subsequent example, each of the plurality of motor modules may include a first gear associated with an output shaft of the motor so that activation of the motor rotates the first gear, which rotates the actuation point of the strut to adjust the length of the strut. In some examples, each of the plurality of motor modules may further include a second gear arranged and configured to interact with the first gear so that actuation of the motor rotates the first gear, which rotates the second gear, which rotates the actuation point of the strut to adjust the length of the strut.

Alternatively, in some examples, the actuation point of the strut may include gear teeth so that activation of the motor rotates the first gear, which rotates the actuation point of the strut to adjust the length of the strut.

[0036] In any preceding or subsequent example, the first gear and the optional second gear are spur or pinion gears.

[0037] In any preceding or subsequent example, where the second gear is included, the second gear includes a connection mechanism extending therefrom, the connection mechanism arranged and configured to engage the actuation point.

[0038] In any preceding or subsequent example, the connection member is selected from one of a male Torx or hex arranged and configured to engage a corresponding female Torx or hex formed in the actuation point. [0039] In any preceding or subsequent example, each of the plurality of motor modules further include a worm gear arranged and configured to interact with, either directly or indirectly, the actuation point of the strut so that activation of the motor rotates the worm gear, which rotates the actuation point of the strut to adjust the length of the strut. For example, activation of the motor may rotate the worm gear, which may rotate a second gear, which rotates the actuation point of the strut to adjust the length of the strut. Alternatively, the actuation point on the strut may include gear teeth thereby eliminating the need for the second gear so that activation of the motor rotates the first gear, which rotates the actuation point of the strut to adjust the length of the strut.

[0040] In any preceding or subsequent example, where the second gear is included, the second gear includes a connection mechanism extending therefrom, the connection mechanism arranged and configured to engage the actuation point.

[0041] In any preceding or subsequent example, the connection member is selected from one of a male Torx or hex arranged and configured to engage a corresponding female Torx or hex formed in the actuation point.

[0042] In any preceding or subsequent example, each of the plurality of motor modules is configured as a standalone unit including a housing; a motor; a printed-circuit board including a microprocessor and a communication chip; and a power supply arranged and configured to provide power to the motor and printed-circuit board.

[0043] In any preceding or subsequent example, each of the plurality of motor modules is communicatively coupled to a central controller. The central controller is arranged and configured to transmit power and data to each of the plurality of motor modules.

[0044] Examples of the present disclosure provide numerous advantages. For example, by providing selectively attachable and detachable motor modules, conventional manually adjustable struts can be utilized with only minor design modifications. Because the motors and electronics can be attached after the patient leaves the operating room and they can be removed for imaging, if desired, the risk of adversely affecting the performance of either heat sensitive or chemically sensitive electronics during sterilization or imaging is effectively removed. In addition, the detachable motor modules enable the struts to be manually adjusted (e.g., rotated). Thereafter, with the motor modules coupled to the struts, motorized and/or automated adjustment of the struts according to a treatment plan can be achieved.

[0045] Further features and advantages of at least some of the examples of the present disclosure, as well as the structure and operation of various examples of the present disclosure, are described in detail below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] By way of example, specific examples of the disclosed device will now be described, with reference to the accompanying drawings, in which: [0047] FIG. 1 illustrates a perspective view of a conventional spatial frame including first and second platforms and a plurality of manually adjustable struts coupled thereto;

[0048] FIG. 2A illustrates a perspective view of an example of a motor module coupled to one of the manually adjustable struts and platforms in FIG. 1 in accordance with one or more features of the present disclosure;

[0049] FIG. 2B illustrates a perspective view of the motor module in FIG. 2A;

[0050] FIG. 3A illustrates a perspective view of an alternate example of a motor module coupled to one of the manually adjustable struts and platforms in FIG. 1 in accordance with one or more features of the present disclosure;

[0051] FIG. 3B illustrates an alternate perspective view the motor module coupled to the manually adjustable strut and platform in FIG. 3A;

[0052] FIG. 3C illustrates a perspective view of the motor module in FIG. 3A; and

[0053] FIG. 3D illustrates a cross-sectional view of the motor module in FIG. 3C

[0054] The drawings are not necessarily to scale. The drawings are merely representations, not intended to portray specific parameters of the disclosure. The drawings are intended to depict various examples of the disclosure, and therefore are not considered as limiting in scope. In the drawings, like numbering represents like elements.

DETAILED DESCRIPTION

[0055] Various features or the like of a motor module will now be described more fully herein with reference to the accompanying drawings, in which one or more features of the motor module will be shown and described. It should be appreciated that the various features may be used independently of, or in combination, with each other. It will be appreciated that the motor module as disclosed herein may be embodied in many different forms and may selectively include one or more concepts, features, or functions described herein. As such, the motor module should not be construed as being limited to the specific examples set forth herein. Rather, these examples are provided so that this disclosure will convey certain features of the motor module to those skilled in the art.

[0056] In accordance with one or more features of the present disclosure, a motor module is disclosed. As will be described in greater detail, in use, the motor modules are arranged and configured to be used in a spatial frame. In use, the spatial frame includes a plurality of manually adjustable struts coupled to, or associated with, (terms used interchangeably without the intent to limit or distinguish) first and second platforms such as, for example, spatial frame 10 including manually adjustable struts 40 coupled to first and second platforms 20, 30. In use, movement, adjustment, etc. of the struts 40 move the first and second platforms 20, 30, and hence the first and second bone portions coupled thereto. [0057] In use, one of a plurality of motor modules may be coupled to one of the plurality of manually adjustable struts 40. Thus arranged, the spatial frame 10 can be selectively configured to operate in either of a first or manually adjustable mode or configuration of operation wherein each strut may be manually adjusted or a second or motorized mode or configuration of operation wherein a motor module may be coupled to each strut to facilitate motorized and/or automated adjustment of the struts. Thus arranged, in use, the plurality of struts can be manually adjusted to, for example, facilitate initial construction of the spatial frame in the operating room, to allow patients to manually adjust the struts, if desired, etc. In addition, by coupling a motor module to each of the struts, the adjustments can be motorized and/or automated, thereby providing greater flexibility to doctors and patients in carrying out the prescribed treatment plan.

[0058] In some examples, the motor modules may be arranged and configured as a self-contained unit including an enclosure, a body, or a housing (terms used interchangeably herein without the intent to limit or distinguish) containing a motor, a power supply, a microprocessor, and all other power and control circuity needed to engage and control a manually adjustable strut in a spatial frame (e.g., to engage and rotate the actuation point 46 of the manually adjustable strut 40). Thus arranged, each motor module may be arranged and configured to receive and transmit data with an external computing system such as, for example, an external computer, an APP running on a smartphone or tablet, etc.

[0059] That is, for example, each motor module may include a motor and a torque transmitting mechanism such as, for example, a gear, arranged and configured to engage a corresponding gear coupled to, or associated with, the actuation point 46 on a manually adjustable strut 40 in the spatial frame 10. In use, actuation of the motor in the motor module enables motorized rotation of the torque transmitting mechanism and thus the manually adjustable strut coupled to the motor module.

[0060] In some examples, each motor module may include a microcontroller or microprocessor (terms used interchangeably herein without the intent to limit or distinguish) arranged and configured to control operation of the motor module including, for example, receiving and/or updating a treatment plan, and/or controlling activation of the motor without the need for a separate centralized control unit positioned within, or associated with, the spatial frame. Each motor module may further include a wireless communication chip or antenna arranged and configured to communicate with an external computing system to, for example, exchange data relating to strut position, exchange data relating to and updating the prescribed treatment plan, etc. Each motor module may also include a power supply such as, for example, batteries, to power the motor module including, for example, the motor, the microcontroller, the wireless communication chip, and any associated sensors and/or additional circuity. Each motor module may also include one or more sensors for positional control, biomechanical feedback, a fault level detection in the gear train, etc., or any combination thereof. Thus arranged, in some examples, each motor module may include its own self-contained power management, wireless communication, and microcontroller unit that controls the position (e.g., length) of the strut. [0061] Alternatively, each motor module may be coupled to one or more separate centralized control units, central controllers, master control units, or the like (terms used interchangeably herein without the intent to limit or distinguish). In use, the central controller may be positioned on or within a platform of the spatial frame. In use, the central controllers may include, for example, a battery and a centrally located control unit arranged and configured to provide localized intelligence to supply data and/or power to each of the plurality of motor modules coupled thereto. In some examples, each motor module may be coupled to the central controller via a hardwire connection (either directly or indirectly in a daisy-chain fashion). Alternatively, in some examples, each motor module may be wirelessly coupled to the central controller and/or to each other.

[0062] Thus arranged, in some examples, each of the motor modules may be powered and controlled by a wired connection to a centralized controller, which is coupled to the platform of the spatial frame. The centralized controller may be arranged and configured to control the motor’s speed and direction according to the treatment plan. The centralized controller may also provide hardware and software protections that prevent any deviation from the treatment plan and alert’s the user in case of any malfunctions. Furthermore, the centralized controller may also contain the power supply for the entire system and a USB interface to allow a wired connection to a nearby computer or a wireless communication chip to allow a wireless connection to an external computing system. Thus arranged, the spatial frame may include a centralized controller coupled to one of the platforms thereof. The centralized controller including all of the intelligence and power supply for controlling and powering each of the plurality of motor modules to which the centralized controller is coupled to. In addition, in use, the centralized controller is arranged and configured to communicate with a remote, external computing device for transmitting and/or receiving data, instructions, etc.

[0063] In some examples, as previously mentioned, the central controller may also be arranged and configured to provide power to each of the plurality of motor modules. That is, the central controller may include a power supply such as, for example, a rechargeable lithium battery, so that when the central controller is coupled to the motor modules, the central controller supplies power to each of the plurality of motor modules.

[0064] In some examples, the central controller may be arranged and configured to be mechanically coupled to one of the first and second platforms. For example, the central controller may be arranged and configured within an enclosure, the enclosure being mounted on, coupled to, or clipped onto, an external surface of one of the first and second platforms. In use, the central controller may have any suitable shape and size now known or hereafter developed. In some alternate examples, the central controller may be arranged and configured in the shape of a ring, or a partial ring, so that when the central controller is coupled to one of the platforms (e.g., ring-shaped platform), the central controller is either co-planar or slightly above the connected platform.

Alternatively, in some examples, the central controller may include a plurality of separate controllers integrated within the platforms such as, for example, within the spaces between the tabs of the platforms as generally described in International Patent Application No. PCT/US2020/052276, filed on September 23, 2020, published as WO 2021/061816 Al (now U.S. Patent Application No. 17/763,792, published as US 2022/0354539), entitled “Automated Spatial Frame and Automated Struts Used

Therewith.”

[0065] In some examples, the central controller may be coupled to the motor modules by any suitable mechanism now known or hereafter developed. For example, the central controller may be coupled to the motor modules to exchange data and deliver power to the motor modules. In some examples, the central controller may be coupled to one or more of the motor modules via a hardwire and connector such as, for example, a micro-USB type connector, a jack plug style connector, PCB cable connectors, IDC connectors, etc.

[0066] Thus arranged, in some examples, the present disclosure provides a spatial frame and associated system architectural for an improved motorized and/or automated auto-adjusting system. In some examples, the spatial frame includes first and second platforms, a plurality of manually adjustable length struts coupled to the first and second platforms, and one or more motor modules. In a preferred example, the system includes a plurality of motor modules, one for each of the plurality of manually adjustable struts. In addition, in some examples, the system may include a central controller coupled to each of the plurality of motor modules for controlling the movement of the struts and/or for suppling power to each of the plurality of motor modules. Alternatively, as previously mentioned, in some examples, each of the plurality of motor modules may be arranged and configured as a self-contained assembly including any needed circuity for controlling, powering, etc. movement of the strut. [0067] In either scenario, the system is preferably arranged and configured to exchange (e.g., transmit and/or receive) data with an external computing system. For example, the central controller and/or the motor modules may be arranged and configured to transmit and receive instructions. The instructions including, for example, length adjustment instructions, timing instructions, etc. for each of the plurality of struts. As such, in use, the central controller and/or the plurality of motor modules may receive and transfer power and/or receive and transmit data relating to (a) patient compliance, (b) healing status (via, for example, the force exerted by the actuator via motor current), (c) treatment plan (e.g., distraction length, lengthening direction, rate and rhythm of distraction, total amount of distraction, lengthening schedule, number of turns of the motor/gear assembly, date and time) and (d) the health of the motor module and/or central controller (e.g., battery life/voltage, and error events relating to the motor (over current, over voltage, temperature).

[0068] Additional information on examples of motorized and/or automated spatial frames, and components associated therewith, can be found in International Patent Application No. PCT/US2020/052276, filed on September 23, 2020, published as WO 2021/061816 Al (now U.S. Patent Application No. 17/763,792, published as US 2022/0354539), entitled “Automated Spatial Frame and Automated Struts Used Therewith,” and International Patent Application No. PCT/US2023/013011, filed February 14, 2023, published as WO 2023/163874 entitled “Detachable Geared-Motor Assembly for Motorizing a Strut in a Spatial Frame,” the contents of each application being hereby incorporated in its entirety herein. [0069] With additional reference to FIGS. 2A and 2B, an example of a motor module 100 is disclosed. As illustrated, the motor module 100 is selectively arranged and configured to couple to one of the platforms such as, for example, the first platform 20 shown in spatial frame 10 of FIG. 1. In addition, as illustrated, the motor module 100 is selectively arranged and configured to engage, attach, couple, etc. to one of the manually adjustable length struts such as, strut 40 of the spatial frame 10 of FIG. 1. Thus arranged, the spatial frame 10 can be operated in and switched between two modes or configurations of operation. In the first mode or configuration of operation, the struts 40 may be manually adjustable. In the second mode or configuration of operation, a motor module 100 may be attached to one or more of the manually adjustable struts 40 to enable motorized and/or automated adjustment of the struts 40.

[0070] That is, as described herein, in use, the motor modules 100 may be selectively coupled to the ends (e.g., actuation points 46) of the strut 40 thus allowing easy mounting after the operation affixing the spatial frame 10 to the patient’s bone. As will be described, the motor module 100 may engage the manually adjustable struts 40 via gears, which allows the lead screw 44 of the strut 40 to move (e.g., to rotate) in either direction to lengthen or shorten the overall length of each strut 40.

[0071] In use, the motor module 100 is arranged and configured to couple (either directly or indirectly) to one of the platforms 20, 30 (shown as platform 20). For example, the motor module 100 may include a coupling mechanism 130. In some examples, as illustrated, the coupling mechanism 130 may be in the form of one or more cylinders, projections, pegs, etc. 132 (terms used interchangeably herein without the intent to limit or distinguish) arranged and configured to be received within one or more holes or openings 22 formed in the platform 20 for coupling the motor module 100 to the platform 20. In addition, the motor module 100 includes a mechanism such as a torque transmitting mechanism or gears 114, 120, that engages, interacts with, etc. the actuation point 46 formed on the end of the manually adjustable strut 40 extending through one of the holes or openings 22 formed in the first platform 20, although this is one configuration and it is envisioned that the actuation point 46 may extend through a hole formed in the second platform 30 so that it extends below the second platform. Thus arranged, activation of the motor contained within the motor module 100 rotates the actuation point 46 of the strut 40 which adjusts the overall length of the strut 40.

[0072] That is, as illustrated, in some examples, the motor module 100 may include a housing 102. In addition, the motor module 100 includes a motor 110 such as, for example, a DC motor, although any suitable motor can be used. In use, the motor 110 includes an output shaft 112 that is coupled to a gear 114 such as, for example, a spur gear or a pinion gear, although any suitable gear may be utilized. In addition, the motor module 100 may include, or be associated with, a second gear 120. In use, the second gear 120 may include, or be associated with, for example, a connection mechanism 122 such as, for example, a male Torx, a hex feature, or the like arranged and configured to engage, interact with, etc., the actuation point 46 of the manually adjustable strut 40, although this is but one configuration and the gear 120 may include any suitable connection mechanism arranged and configured to engage the corresponding actuation point 46 positioned at the end of the strut 40. In use, the second gear 120 is arranged and configured to interact with the first gear 114 associated with the output shaft 112 of the motor 110, although this is but one configuration and others are envisioned. For example, one or more intermediate or idler gears may be used in-between the first and second gears. In use, with the outer body 42 of the strut 40 non-rotatable fixed to the second platform 30, actuation of the motor 110 rotates the first gear 114, which rotates the second gear 120, which rotates the actuation point 46 resulting in motorized adjustment of the strut 40. Although this is but one configuration and it is envisioned that the outer body 42 may be coupled to the first platform 20 and the actuation point 46 may be associated with the second platform 30. Moreover, in some examples, the actuation point of the strut may include gear teeth arranged and configured to interact with the first gear directly. Thus arranged, in use, activation of the motor rotates the first gear, which rotates the actuation point of the strut to adjust the length of the strut.

[0073] In addition, as illustrated, the housing 102 of the motor module 100 may include a coupling mechanism 130 arranged and configured to couple the motor module 100 to the platform 20. In use, the coupling mechanism 130 may be any suitable coupling mechanism 130 now known or hereafter developed such as, for example, adhesive, clips, fasteners, clamps, etc. In some examples, as previously mentioned, the coupling mechanism 130 may include one or more cylinders 132. That is, the housing 102 of the motor module 100 may include one or more cylinders 132. In use, the cylinders 132 are arranged and configured to engage, be inserted into, be received by, etc. one or more of the holes or openings 22 formed in the platform 20. In some examples, receipt of the cylinders 132 into the holes or openings 22 formed in the platform 20 may create an interference fit, a snap-fit, or the like. Alternatively, in some examples, the cylinders 132 may include external threads arranged and configured to receive an internally threaded nut. As such, in use, with the cylinders 132 inserted into the holes or openings 22 formed in the platform 20, the nut could be threaded onto the cylinders 132 below the platform 20 to securely fasten the motor module 100 to the platform 20, although any suitable connection mechanism could be used including, for example, clamping mechanism, which may eliminate the need for utilizing the holes or openings 22 in the platform 20. In some examples, the housing 102 of the motor module 100 may include first and second cylinders 132 position on either side of the connection mechanism 122 associated with the second gear 120, the first and second cylinders 132 mating with holes or openings 22 formed in the platform 20 so that the motor module 100 is rigidly affixed to the platform 20.

[0074] In some examples, as previously mentioned, in use, each motor module 100 may include any necessary circuity or electronics (e.g., printed-circuit boards (“PCBs”)) needed to control and/or power the motor module 100. For example, in some examples, each motor module 100 may include all necessary power supply and electronics to operate the motor module 100 and motor 110 to rotate the actuation point 46 of the strut 40. Thus, each motor module 100 can be configured with its own battery and electronics. Alternatively, each motor module 100 may be configured to couple (either wirelessly or wired) to one or more central controllers for receiving power and/or instructions. Thus arranged, the spatial frame may include a centralized controller, which is mounted onto one of the platforms to allow for autonomous adjustments of the motor modules and hence the struts. The centralized controller may be connected to each of the motor modules via a digital two-wire bus USB connection providing power and positional data. [0075] While a particular motor module has been described and illustrated in connection with FIGS. 2A and 2B, it should be appreciated that the motor module may have other configurations so long as the motor module is arranged and configured to interact with the actuation point 46 formed on the end of the strut 40. For example, as previously mentioned, the interacting connection mechanism 122 between the motor module 100 and the actuation point 46 may be any suitable connection mechanism now known or hereafter developed. For example, the actuation point could be a male feature and the motor module could include a female feature for engaging with the male feature. Alternatively, and/or in addition, the motor 110 positioned within the housing 102 of the motor module 100 could be orientated to extend upwards, away from the upper surface of the platform 20 instead of downwards. In addition, and/or alternatively, in some examples, by incorporating more complex gearing, a single motor module could be used to actuate multiple struts, for example, a single motor module could be configured to operate first and second adjacent struts. Thus arranged, for example, a fully motorized spatial frame in a typical hexapod configuration could be achieved with three motor modules.

[0076] Alternatively, with reference to FIGS. 3A-3D, in an alternate example of a motor module 200, the output shaft of the motor 210 may be configured with a worm gear configuration. That is, as illustrated, the motor module 200 may include a housing 202. In addition, the motor module 200 includes a motor 210 such as, for example, a DC motor, although any suitable motor can be used. In use, the motor 210 includes an output shaft that is configured as, or is coupled to, a worm gear 214 that is arranged and configured to interact with a second gear 220 associated with the actuation point 46 on the manually adjustable strut 40 (e.g., the second gear 220 may include, or be associated with, for example, a connection mechanism 222 such as, for example, a male Torx, a hex feature, or the like arranged and configured to engage, interact with, etc., the actuation point 46 of the manually adjustable strut 40). In use, the second gear 220 is arranged and configured to interact with the worm gear 214 associated with the motor 210. Thus arranged, in use, with the outer body 42 of the strut 40 non-rotatable fixed to the second platform 30, actuation of the motor 210 rotates the worm gear 214, which rotates the second gear 220, which rotates the actuation point 46 resulting in motorized adjustment of the strut 40. Although this is but one configuration and it is envisioned that the outer body 42 may be coupled to the first platform 20 and the actuation point 46 may be associated with the second platform 30. Moreover, in some examples, the actuation point of the strut may include gear teeth arranged and configured to interact with the worm gear directly. Thus arranged, in use, activation of the motor rotates the worm gear, which rotates the actuation point of the strut to adjust the length of the strut.

[0077] Thus arranged, the motor module 200 may be orientated horizontally relative to the platform 20 (e.g., parallel to the platform 20). In use, the housing 202 of the motor module 200 may be coupled to the platform 20 via any suitable coupling mechanism 230 arranged and configured to couple the motor module 200 to the platform 20. In use, the coupling mechanism 230 may be any suitable coupling mechanism now known or hereafter developed such as, for example, adhesive, clips, fasteners, clamps, cylinders (as previously described), etc. For example, the motor module 200 may include one or more cylinders, projections, pegs, etc. arranged and configured to be received within one or more holes formed in the platform 20. Alternatively, for example, the housing 202 of the motor module 200 may include connectors to allow for the connection of fixation components, additional clamps, ring blocks, and other frame components. Connectors could include holes, posts, threads, or the like. Thus arranged, the motor module 200 could be configured as a component of frame construction, limiting the valuable real-estate space required.

[0078] In accordance with one or more features of the present disclosure, by incorporating a motor module 100, 200 arranged and configured to engage a protruding actuation point 46 formed at the end of an otherwise manually adjustable strut 40, motorized adjustments of the strut 40 can be achieved. This configuration provides potential benefits such as allowing shorter minimum strut length, simplifying strut design, and/or reducing the number of bulky components between the platforms.

[0079] In use, the motor modules 100, 200 can be coupled to the manually adjustable struts 40 of the spatial frame 10. In some examples, the motor modules 100, 200 may be coupled to the manually adjustable struts 40 after surgery in clinic by, for example, a primary care provider. Alternatively, the motor modules 100, 200 may be coupled to the manually adjustable struts 40 at any time and by anyone. Once coupled, the motor modules 100, 200 may facilitate motorized and/or automated adjustments such as, for example, semi-continuous actuation. For example, the motor modules 100, 200 may enable motorized adjustments to be made autonomously via a companion APP running on, for example, a smartphone, a tablet, or other external computing system. Thus arranged, the spatial frame and/or system architecture may be arranged and configured to automatically adjust the motor modules 100, 200, and hence the struts 40, according to the prescribed treatment plan (e.g., automatically adjust the plurality of motor modules 100, 200 without patient intervention). Alternatively, and/or in addition, the spatial frame and/or system architecture may be arranged and configured to require patient and/or caregiver activation to begin the process of automatically adjusting the motor modules 100, 200 according to the prescribed treatment plan. For example, the spatial frame may be arranged to intermittently auto-adjust the motor modules 100, 200 at predetermined times according to the treatment plan. Alternatively, the spatial frame may be arranged to intermittently auto-adjust the motor modules 100, 200 at selected times when convenient and/or when selected by the patient.

[0080] Thus arranged, in accordance with one or more features of the present disclosure, a number of advantages are achieved. For example, by utilizing detachable motor modules 100, 200, motorized and/or automated adjustments of a spatial frame can be achieved. In use, the motor modules 100, 200 are arranged and configured to engage a manually adjustable strut 40 in an outpatient setting thus enabling the spatial frame to be operated in two different modes or configurations: (a) a standard, manual adjustment mode where the lengths of the struts 40 can be adjusted by manual rotation of the lead screw and (b) motorized and/or automated adjustment via the detachable motor modules 100, 200.

[0081] In addition, by utilizing detachable motor modules 100, 200, existing features of the manually adjustable struts are retained. That is, with the motor modules 100, 200 detached from the manually adjustable struts, operation of the struts is unaffected. For example, if the manually adjustable strut incorporates a quick adjustment feature to enable manual lengthening of the strut without rotating the lead screw, such adjustment feature is retained thus enabling faster adjustment during, for example, initial setup in the operating room.

[0082] In some examples, the motor modules 100, 200 may include an IP-68 rated housing manufactured from any suitable material including, for example, a metal or metal alloy, a polymer, a light-weight material such as PEEK, nylon, aluminum, etc. In addition, the housing may be manufactured via any now known or hereafter developed technique such as, for example, injection molding, additive manufacturing, etc.

[0083] In accordance with one or more features of the present disclosure, in use, with the motor modules 100, 200 coupled to the struts 40, the spatial frame 10 may be configured to execute adjustments and/or manipulations of bone segments in accordance with a prescribed schedule and/or a prescription. The prescription may dictate a magnitude of each adjustment, direction of each adjustment, time of each adjustment, frequency of adjustments, etc. Adjustments may be executed using a single motor module 100, 200 and/or any combination of motor modules 100, 200. The motor modules 100, 200 may adjust to different magnitudes, different directions, different frequencies, etc. The prescription may be uploaded to the spatial frame wirelessly and/or using a temporary wired connection with an external device. The communications with the motor modules 100, 200 either directly, or via a centralized controller, may be performed using one or more of its antenna(s), wireless receiver(s), wireless transmitter(s), wireless communication chip(s) and/or any other hardware/software. [0084] In accordance with one or more features of the present disclosure, motorization and/or automation of an existing manual strut is achieved in a significantly simpler manner thus reducing risk of failure. In various examples, the motor modules eliminate the need for sterilization and offer a quick and simple method for implementing motorized and/or automated adjustment capability in a treatment plan. A companion APP can be used to transmit and receive commands and updates. For example, the companion APP can be configured to scan for beacons at set time intervals and establish connections with one or more of the motor modules (either directly or via a centralized controller). The connections enabling the receipt and/or transmission of data, updates, etc. The companion APP can be programmed to track a patient’s treatment plan in terms of (a) force-feedback, (b) date and time of distraction, (c) lengthening schedule/direction, (d) rate (mm/day) and rhythm (steps/day) of distraction, (e) distraction length and (f) potential adverse events/complications.

[0085] While the present disclosure refers to certain examples, numerous modifications, alterations, and changes to the described examples are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described examples, but that it has the full scope defined by the language of the following claims, and equivalents thereof. The discussion of any example is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples. In other words, while illustrative examples of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0086] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more examples or configurations for the purpose of streamlining the disclosure.

However, it should be understood that various features of the certain examples or configurations of the disclosure may be combined in alternate examples or configurations. Any example or feature of any section, portion, or any other component shown or particularly described in relation to various examples of similar sections, portions, or components herein may be interchangeably applied to any other similar example or feature shown or described herein. Additionally, components with the same name may be the same or different, and one of ordinary skill in the art would understand each component could be modified in a similar fashion or substituted to perform the same function.

[0087] Moreover, the following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate example of the present disclosure.

[0088] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to “one example” of the present disclosure are not intended to be interpreted as excluding the existence of additional examples that also incorporate the recited features. [0089] The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader’s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., engaged, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. All rotational references describe relative movement between the various elements. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority but are used to distinguish one feature from another. The drawings are for purposes of illustration only and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

Claims

1. A spatial frame, comprising: a first platform; a second platform spaced from the first platform; a plurality of adjustable length struts, each of the plurality of adjustable length struts coupled to the first platform and the second platform, each of the adjustable length struts including a body and a lead screw, wherein the lead screw is arranged and configured to move relative to the body to adjust a length of the strut, each of the struts including an actuation point located at an end thereof; and a plurality of motor modules, each of the plurality of motor modules being arranged and configured to couple to one of the first and second platforms and to one of the actuation points of one of the plurality of adjustable length struts, wherein each of the plurality of motor modules is arranged and configured to actuate motorized rotation of the actuation point to adjust the length of the strut to which it is coupled.

2. The spatial frame of claim 1, wherein the first platform includes a plurality of holes formed therein, the actuation point extending through one of the plurality of holes formed in the first platform.

3. The spatial frame of claim 2, wherein each of the plurality of motor modules includes a housing, a motor at least partially disposed within the housing, and a coupling mechanism arranged and configured to engage the first platform.

4. The spatial frame of claim 3, wherein the coupling mechanism includes one or more cylinders, the one or more cylinders arranged and configured to be received within one or more of the holes formed in the first platform.

5. The spatial frame of claim 4, wherein the one or more cylinders include first and second cylinders, the first and second cylinders configured to be positioned within first and second holes formed in the first platform.

6. The spatial frame of claim 5, wherein the first and second holes formed in the first platform for receiving the first and second cylinders are positioned on either side of the hole for receiving the actuation point.

7. The spatial frame of claim 3, wherein each of the plurality of motor modules further include a first gear associated with an output shaft of the motor so that activation of the motor rotates the first gear, which rotates the actuation point of the strut to adjust the length of the strut.

8. The spatial frame of claim 7, further comprising a second gear arranged and configured to interact with the first gear so that activation of the motor rotates the first gear, which rotates the second gear, which rotates the actuation point of the strut to adjust the length of the strut.

9. The spatial frame of claim 8, wherein the first and second gears are spur or pinon gears.

10. The spatial frame of claim 8, wherein the second gear includes a connection mechanism extending therefrom, the connection mechanism arranged and configured to engage the actuation point.

11. The spatial frame of claim 10, wherein the connection member is selected from one of a male Torx or hex arranged and configured to engage a corresponding female Torx or hex formed in the actuation point.

12. The spatial frame of claim 3, wherein each of the plurality of motor modules further include a worm gear arranged and configured to interact with the actuation point of the strut so that activation of the motor rotates the worm gear, which rotates actuation point of the strut to adjust the length of the strut.

13. The spatial frame of claim 12, further comprising a second gear arranged and configured to interact with the worm gear so that activation of the motor rotates the worm gear, which rotates the second gear, which rotates the actuation point of the strut to adjust the length of the strut.

14. The spatial frame of claim 13, wherein the second gear includes a connection mechanism extending therefrom, the connection mechanism arranged and configured to engage the actuation point.

15. The spatial frame of claim 14, wherein the connection member is selected from one of a male Torx or hex arranged and configured to engage a corresponding female Torx or hex formed in the actuation point.

16. The spatial frame of claim 1, wherein each of the plurality of motor modules is configured as a standalone unit including a housing; a motor; a printed-circuit board including a microprocessor and a communication chip; and a power supply arranged and configured to provide power to the motor and printed-circuit board.

17. The spatial frame of claim 1, wherein each of the plurality of motor modules is communicatively coupled to a central controller.

18. The spatial frame of claim 17, wherein the central controller is arranged and configured to transmit power and data to each of the plurality of motor modules.