Detachable motor

The detachable motor system for bone fixation devices addresses the inefficiencies in strut length adjustment and maintenance by providing a kit with a detachable motor unit that can be easily attached and detached from the motor adapter, enhancing operational efficiency and ease of maintenance.

JP7693983B2Active Publication Date: 2025-06-18SYNTHES GMBH
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Patent Information

Application Number
JP2023505985
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-07-30
Filing Date
2021-07-29
Publication Date
2025-06-18
Estimated Expiration
2041-07-29

AI Technical Summary

Technical Problem

Existing bone fixation devices lack a detachable motor system that allows for easy attachment and detachment of motor units, leading to inefficiencies in strut length adjustment and maintenance.

Method used

A detachable motor system comprising a kit that includes a strut with a linear actuator, a motor adapter with a motor fastener, and a motor unit that can be selectively detached from the motor fastener, allowing for axial extension of the strut.

Benefits of technology

The detachable motor system enables efficient adjustment of strut length, facilitates easy maintenance by allowing motor unit replacement without replacing the entire strut, and reduces the risk of motor misalignment.

✦ Generated by Eureka AI based on patent content.

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Abstract

A kit comprising: a strut of a bone fixation device including a fixation portion and an extension portion, the strut comprising a linear actuator mechanically connected to the extension portion; at least one motor adapter coupled to the linear actuator, the motor adapter comprising a motor fastener; at least one motor unit selectively detachable from the motor fastener, the motor unit operatively coupled to the linear actuator and configured to axially extend the extension portion of the strut; A kit, wherein the motor fastener is shaped and sized to receive a portion of the motor unit.
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Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 058,686, filed Jul. 30, 2020, the entire content of which is incorporated herein by reference.

[0002] (Field of the Invention) In some embodiments, the present invention relates to a detachable motor, and more particularly, but not limited thereto, to a detachable motor of a bone fixation device.

Summary of the Invention

Means for Solving the Problems

[0003] Some examples of some embodiments of the present invention are listed below. Features from one example may be combined with features from other examples:

[0004] Example 1. A kit comprising: A strut of a bone fixation device including a fixed portion and an extending portion, the strut comprising a linear actuator mechanically connected to the extending portion; At least one motor adapter coupled to the linear actuator, the motor adapter comprising a motor fastener; At least one motor unit selectively detachable from the motor fastener, the motor unit being functionally coupled to the linear actuator and configured to axially extend the extending portion of the strut; The kit, wherein the motor fastener is shaped and sized to receive a portion of the motor unit.

[0005] Example 2. The kit according to Example 1, wherein the motor fastener is shaped and sized to receive an end of the motor unit and to inhibit lateral movement of the end of the motor unit.

[0006] Example 3. The kit according to Example 1 or 2, wherein the motor fastener includes a socket formed to receive the motor end portion.

[0007] Example 4. The kit according to Example 3, wherein the motor unit includes a housing, a motor, and a gear extending from the motor unit within the housing, and an end portion of the motor unit includes a part of the gear extending from the housing.

[0008] Example 5. The kit according to Example 4, wherein the part of the gear extending from the housing has a diameter smaller than the diameter of the motor housing.

[0009] Example 6. The kit according to any one of Examples 3 to 5, wherein the motor end portion is a conical motor end portion and / or a tapered motor end portion formed to be disposed within the socket.

[0010] Example 7. The kit according to any one of Examples 1 to 6, wherein the support includes one or more radially extending portions that interface with the motor adapter.

[0011] Example 8. The kit according to any one of Examples 1 to 7, wherein the motor adapter includes a housing having one or more openings, and the housing is attached to the support by one or more screws or pins.

[0012] Example 9. The kit according to any one of Examples 1 to 7, wherein the motor adapter includes a housing having one or more openings formed to receive the support, and an inner diameter of the opening is larger than an outer diameter of the support.

[0013] Example 10. The kit according to Example 9, wherein the one or more openings form channels sized and shaped to receive the support.

[0014] Example 11. The kit according to Example 9 or 10, wherein an inner portion of the one or more openings is circular.

[0015] Example 12. The kit according to any one of Examples 9 to 11, wherein the support has a window and the motor adapter does not block the window when the motor adapter is coupled to the support.

[0016] Example 13. The kit according to any one of Examples 9 to 12, wherein the support has a visual indicator indicating an extension length of the support, and the motor adapter housing has a window or one or more elongated openings that are at least partially aligned with the visual indicator when the motor adapter is coupled to the support.

[0017] Example 14. The kit according to any one of Examples 9 to 13, comprising at least one motor connector shaped and sized to fasten the motor unit to the housing of the motor adapter.

[0018] Example 15. The kit according to Example 14, wherein the motor connector fits into an opening in the housing and has one or more protrusions configured to lock the motor connector to the housing.

[0019] Example 16. The kit according to Example 14 or 15, wherein the motor unit has a groove and the motor connector is shaped and sized to fit into the groove when the motor unit is fastened to the motor adapter housing.

[0020] Example 17. The kit according to any one of Examples 14 to 16, wherein the motor connector has a clip.

[0021] Example 18. The kit according to any one of Examples 1 to 17, wherein the support has a gear of the linear actuator located near the extending portion of the support.

[0022] Example 19. The kit according to Example 18, wherein the linear actuator gear is located at a distance of up to 5 cm from the extending portion.

[0023] Example 20. The kit according to Example 18 or 19, wherein the motor adapter comprises a gear, and the motor adapter gear is configured to be interlocked with the linear actuator gear when the motor adapter is coupled to the support column, whereby rotation of the motor adapter gear axially moves the linear actuator.

[0024] Example 21. The kit according to Example 20, wherein the motor end interacts with the motor adapter gear when the motor is selectively attached to the motor adapter.

[0025] Example 22. The kit according to Example 21, comprising a manual motor adapter interface shaped and sized to be interlocked with the motor adapter gear such that manual rotation of the manual motor adapter interface axially moves the linear actuator.

[0026] Example 23. The kit according to Example 22, wherein the motor adapter gear is alternately interlocked with the manual motor adapter interface and the motor end.

[0027] Example 24. The kit according to Example 22 or 23, wherein the end of the manual motor adapter interface is shaped to be disposed within the motor adapter fastener.

[0028] Example 25. The kit according to any one of Examples 20 to 24, comprising at least one gear lock that is detachable from the motor adapter and configured to interlock and stop the movement of the motor adapter gear.

[0029] Example 26. The kit according to Example 25, wherein the at least one gear lock includes a first end portion disposed within the motor fastener and shaped and sized to be interlocked with the motor adapter gear, and a second end portion extending from the motor fastener and shaped and sized to be interlocked with the housing of the motor adapter.

[0030] Example 27. The kit according to any one of Examples 1 to 26, comprising a bone fixation device including the strut and at least two spaced-apart frames, each frame being configured to be coupled to a different end of the strut and a bone connector extending from the bone.

[0031] Example 28. The kit according to Example 27, wherein at least one of the spaced-apart frames comprises an arc or a ring that at least partially surrounds a patient's limb.

[0032] Example 29. At least one electrical cable and a control unit reversibly coupled to a frame of the at least two frames and connected to the motor and / or the motor adapter by the at least one electrical cable. The kit according to Example 27 or 28.

[0033] Example 30. The kit according to Example 29, comprising a control unit frame interface fixedly connectable to the frame of the at least two frames, and the control unit is configured to be detachable from the control unit frame interface.

[0034] Example 31. The kit according to Example 30, wherein the control unit and / or the control unit frame interface comprises a snap-fit lock or an interference lock configured to enable detachment of the control unit from the control unit frame interface.

[0035] Example 32. A kit according to any one of Examples 29 to 31, comprising one or more cable splitter boxes configured to be fixedly attached to the frame of the bone fixation device and to combine at least two cables extending from two different motors into a single cable connected to the control unit.

[0036] Example 33. A kit according to any one of Examples 29 to 32, comprising one or more cable fasteners configured to be fixedly attached to the frame of the bone fixation device and to fasten the at least one cable to the bone fixation device.

[0037] Example 34. A kit according to any one of Examples 29 to 33, comprising at least one cable wrapper configured to be fixedly attached to the frame of the bone fixation device and to fasten a loose portion of the at least one cable.

[0038] Example 35. A kit according to any one of Examples 29 to 34, wherein the control unit comprises at least one motor connector configured to receive the at least one cable.

[0039] Example 36. A kit according to Example 35, comprising a control circuit connected to the at least one motor connector and a user interface configured to generate a human-detectable instruction, wherein the control circuit sends a signal to the user interface to generate a human-detectable instruction according to a signal received from the at least one motor connector.

[0040] Example 37. A kit according to Example 36, wherein the at least one motor unit comprises at least one electric motor and at least one positioning sensor configured to record the rotation of the at least one electric motor, and the control circuit measures the extension of a strut coupled to the at least one motor unit using the motor rotation record of the at least one positioning sensor.

[0041] Example 38. The kit according to any one of Examples 1 to 37, wherein the linear actuator is a non-electric mechanical linear actuator.

[0042] Example 39. A motor adapter coupled to a strut of a bone fixation device and selectively coupled to a motor unit, a housing coupled to the strut of the bone fixation device, and a motor fastener in the housing shaped and sized to receive and restrain lateral movement of an end of the motor unit.

[0043] Example 40. The adapter according to Example 39, wherein the housing comprises at least one opening shaped and sized to receive the strut.

[0044] Example 41. The adapter according to Example 39 or 40, comprising one or more connectors and / or openings in the housing, the one or more connectors and / or openings configured to attach the motor adapter to the strut of the bone fixation device using one or more pins or screws that traverse the opening.

[0045] Example 42. The adapter according to any one of Examples 39 to 41, wherein the housing comprises a gear in the housing arranged to interact with a gear of a linear actuator of the strut when the housing is coupled to the strut.

[0046] Example 43. The adapter according to Example 42, wherein the motor adapter gear is located in the motor fastener and configured to be interlocked with the motor end.

[0047] Example 44. The adapter according to Example 42 or 43, comprising a motor adapter manual interface that at least partially penetrates the housing and is configured to be interlocked with the motor adapter gear.

[0048] Example 45. The adapter according to Example 44, wherein the motor adapter gear is configured to interlock alternately with the motor end and the motor adapter manual interface.

[0049] Example 46. A method for coupling a motor to a bone fixation device, comprising: coupling an end of the motor to a socket of a motor adapter connected to a strut of the bone fixation device; restraining lateral movement of the motor end by the socket; activating the motor to extend an extending portion of the strut.

[0050] Example 47. The method according to Example 46, wherein the coupling includes functionally coupling the motor end to a linear actuator gear of the strut.

[0051] Example 48. The method according to Example 46 or 47, wherein the coupling includes interlocking the motor end with a gear of the motor adapter.

[0052] Example 49. The method according to any one of Examples 46 to 48, including connecting the motor to a control unit of the bone fixation device, and the activation includes activating the motor by the control unit according to an instruction stored in a memory of the control unit.

[0053] Example 50. The method according to any one of Examples 46 to 49, including adjusting an angle between a horizontal axis of the motor adapter and at least one frame of the bone fixation device before the activation, and locking the motor adapter to the adjusted frame.

[0054] Example 51. The method according to Example 50, wherein the adjustment includes rotating the motor adapter and the strut about a longitudinal axis of the strut.

[0055] Example 52. The method according to Example 46, including attaching the motor adapter to the strut of the bone fixation device before the coupling.

[0056] Example 53. The method according to Example 52, wherein the attachment includes functionally coupling the gear of the motor adapter to the linear actuator of the strut.

[0057] Example 54. The method according to any one of Examples 46 to 53, including identifying that the motor is coupled to the correct strut of the bone fixation device by using a computer to read an identification code associated with the motor before the operation.

[0058] Example 55. The method according to Example 54, wherein the identification code includes RFID and the computer includes an RFID reader.

[0059] Example 56. A method for replacing a strut of a bone fixation device, comprising: removing the motor from the first strut connected to the bone fixation device; in the bone fixation device, replacing the first strut with a second strut; attaching the removed motor to the second strut.

[0060] Example 57. The method according to Example 56, wherein the removal includes removing the motor from the first motor adapter coupled to the first strut, and the attachment includes attaching the motor to the second motor adapter coupled to the second strut.

[0061] Example 58. The method according to Example 56, wherein the removal includes removing the motor adapter connected to the motor from the first strut, and the attachment includes attaching the motor adapter to the second strut.

[0062] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, representative methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will apply. The materials, methods, and examples are illustrative only and not intended to be limiting.

[0063] As will be understood by those of ordinary skill in the art, some embodiments of the present invention may be embodied as a system, method, or computer program product. Accordingly, embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, all of which may be referred to herein generally as a "circuit," "module," or "system." Further, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer-readable media (s) having computer-readable program code embodied therein. The implementation of the methods and / or systems of some embodiments of the present invention can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Further, according to the actual instrumentation and equipment of some embodiments of the methods and / or systems of the present invention, some selected tasks can be implemented by hardware, by software, by firmware, and / or a combination thereof, such as using an operating system.

[0064] For example, the hardware for performing a selected task according to some embodiments of the present invention may be implemented as a chip or a circuit. As software, a selected task according to some embodiments of the present invention may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are executed by a data processor such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data, and / or a non-volatile storage device for storing instructions and / or data, such as a magnetic hard disk and / or a removable medium. Optionally, a network connection is also provided. A display and / or a user input device such as a keyboard or a mouse are also optionally provided.

[0065] In some embodiments of the present invention, any combination of one or more computer-readable media may be utilized. Such computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, but is not limited to, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a comprehensive list) of the computer-readable storage medium would include, hereinafter, namely, an electrical connection having one or two or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of the present disclosure, the computer-readable media may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0066] The computer-readable signal medium may include, for example, a propagated data signal in which the computer-readable program code is embodied, either baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. The computer-readable signal medium is any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0067] The program code embodied on the computer-readable media and / or the data used thereby may be transmitted using any appropriate medium, including wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0068] The computer program code for performing the operations for some embodiments of the present invention may be written in any combination of one or more programming languages including object-oriented programming languages such as Java, Smalltalk, C++, C#, and conventional procedural programming languages such as the "C" programming language or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer as a stand-alone software package, partially on the user's computer, partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0069] Some embodiments of the present invention may be described herein with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowcharts and / or block diagrams, and combinations of blocks in the flowcharts and / or block diagrams, can be implemented by computer-readable program instructions. These computer program instructions may be provided to the processor of a general purpose computer, a special purpose computer, or other programmable data processing apparatus, such that the instructions, when executed via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / operations specified in one or more blocks of the flowchart and / or block diagram to produce a machine.

[0070] These computer program instructions may also be stored in a computer-readable medium so as to cause a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer-readable medium can produce a manufactured article including instructions for implementing the functions / operations specified in one or more blocks of a flowchart and / or block diagram.

[0071] Loading these computer program instructions onto a computer, other programmable data processing equipment, or other devices causes a series of operational steps to be performed on that computer, other programmable equipment, or other devices, thereby generating a computer-implemented process such that the instructions executed on that computer or other programmable equipment result in a process for implementing the functions / operations defined in the blocks of a flowchart and / or block diagram.

[0072] Some of the methods described herein are generally designed only for use by a computer and may not be feasible or practical for purely manual execution by a human expert. A human expert manually performing a similar task such as controlling and monitoring the elongation of each strut of a bone fixation device may be expected to use a completely different method, for example, leveraging expertise and / or the pattern recognition ability of the human brain, which would likely be far more efficient than performing the steps of the methods described herein manually.

Brief Description of the Drawings

[0073] Here, some embodiments of the present invention will be described herein with reference to the accompanying drawings for purposes of illustration only. Referring specifically to the drawings in detail, it is emphasized that the details shown are exemplary and are for the purpose of providing an exemplary description of embodiments of the present invention. In this regard, the description using the drawings will clarify to those skilled in the art how embodiments of the present invention may be implemented. The drawings are as follows.

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DETAILED DESCRIPTION OF THE INVENTION

[0074] In some embodiments, the present invention relates to a detachable motor, and more particularly, but not limited thereto, to a detachable motor of a bone fixation device.

[0075] Broad aspects of some embodiments relate to coupling, for example, selectively coupling a motor unit to a strut, such as a strut of an orthopedic fixation device, such as an external bone fixation device.

[0076] Aspects of some embodiments relate to suppressing movement of a motor unit coupled to a support column. In some embodiments, movement of the motor unit, e.g., lateral and / or axial movement, is suppressed when the motor unit is coupled to the support column. In some embodiments, movement of the motor unit relative to the support column is suppressed. Optionally, movement of the motor unit relative to a linear actuator of the support column is suppressed. In some embodiments, the motor unit is a detachable motor unit configured to be selectively detached from, e.g., the support column.

[0077] According to some embodiments, the motor unit is selectively coupled to the support column via an adapter, e.g., a motor adapter. In some embodiments, the motor adapter includes at least one motor restraint configured to suppress movement of the motor unit. In some embodiments, the restraints of the motor adapter are configured to suppress lateral and / or axial movement of the motor unit. In some embodiments, the motor unit includes a motor, a drive shaft of the motor, and a gear of the motor. In some embodiments, the gear of the motor is selectively coupled to a linear actuator, e.g., a gear of the linear actuator.

[0078] According to some embodiments, the motor unit is interlocked with a motor adapter connected to, e.g., a linear actuator. In some embodiments, the restraints of the motor adapter interlock the motor unit with the linear actuator. Optionally, the restraints of the motor adapter interlock at least one end of a gear of the motor unit or the motor with a gear of the linear actuator.

[0079] Aspects of some embodiments relate to using the same adapter coupled to a support column for both manual and electric adjustment of the support column. In some embodiments, the manually induced movement and the electrically induced movement are delivered through the same transmission element to an actuator of the support column, such as a linear actuator. In some embodiments, the transmission element is a transmission element coupled to the linear actuator, such as a gear of the linear actuator.

[0080] According to some embodiments, a motor unit and a manual interface for delivering manually induced movement are connected in parallel to the same transmission element. Alternatively, the motor unit and the manual interface are interchangeable.

[0081] Aspects of some embodiments relate to delivering movement to a linear actuator of a support column near an extending portion of the support column. In some embodiments, a transmission element, such as an electric gear, contacts the linear actuator near the extending portion of the support column, for example, at a distance less than 10 cm, less than 8 cm, less than 5 cm, less than 3 cm, less than 2 cm, or any intermediate, smaller, or larger distance from the extending portion of the support column.

[0082] According to some embodiments, the motor unit is coupled to the support column near the extending portion of the support column and away from the fixed end of the support column, for example, at a distance less than 10 cm, less than 8 cm, less than 5 cm, less than 3 cm, less than 2 cm from the extending portion of the support column, or any intermediate, smaller, or larger distance. As used herein, the term "near" means closer to a first location and farther from a second location. In some embodiments, the gear of the motor unit is coupled to the linear actuator of the support column at a distance less than 10 cm, less than 8 cm, less than 5 cm, less than 3 cm, less than 2 cm, or any intermediate, smaller, or larger distance from the extending portion of the support column.

[0083] Aspects of some embodiments relate to the separation in time and location between the connection of an external fixation system to a patient's bone and the coupling of a motor unit to the strut. In some embodiments, the motor unit is coupled to the strut after the surgery to connect the fixation device to the patient's bone has been completed. In some embodiments, the motor unit is coupled to the strut outside of the operating room, such as in a clinic or the patient's home.

[0084] According to some embodiments, during and / or after surgery, the strut length changes, for example, by manual operation of a gear of a motor adapter coupled to the strut, such as a motor adapter. In some embodiments, the motor adapter is manually operated by a manual interface in the motor adapter, such as a manual interface that interacts with a linear actuator of the strut. In some embodiments, the manual interface is removably coupled to the motor adapter and / or the linear actuator. In some embodiments, selectively coupling the motor unit to the motor adapter disconnects the manual interface from the linear actuator. Additionally or alternatively, selectively coupling the motor unit to the motor adapter of the motor unit releases the manual interface from the motor adapter.

[0085] According to some embodiments, the strut connected to the bone fixation device is replaced without replacing the motor unit. In some embodiments, the same motor unit is coupled to the new strut. In some embodiments, the motor unit is removed from the strut, such as from a motor adapter coupled to the strut, before the strut is replaced. Optionally, the motor adapter coupled to the strut, such as fixedly coupled, is replaced with the strut.

[0086] Aspects of some embodiments relate to adjusting the relative position of the strut attachment to minimize external interference during treatment. In some embodiments, the strut attachment comprises at least one motor adapter or motor unit coupled to the strut. Alternatively, the strut attachment comprises a motor unit coupled to the strut, for example via a motor adapter, and at least one wire, such as an electrical wire connecting the motor unit and / or the motor adapter to a control unit. Additionally or alternatively, the relative position of the strut attachment is adjusted according to the patient's anatomical structure and / or the location of an object that may interfere with the treatment.

[0087] According to some embodiments, the angle between a frame, such as a ring of an external fixation device, and a strut assembly comprising a strut and a motor adapter connected to the frame and the strut is adjusted. In some embodiments, the angle between a plane perpendicular and in contact with the ring and the transverse axis of the strut assembly is adjusted. In some embodiments, the angle is adjusted by rotating the strut of the strut assembly about the longitudinal axis of the strut. Optionally, the angle is adjusted before coupling the motor unit to the motor adapter of the strut assembly. Alternatively, the angle is adjusted when the motor unit is coupled to the motor adapter.

[0088] According to some embodiments, the strut assembly is locked at a desired angle relative to the frame or a plane perpendicular and in contact with the frame by a lock, such as a screw or pin, that controls the rotational movement of the strut of the strut assembly about the longitudinal axis of the strut.

[0089] According to some embodiments, the length and / or position of the wire connecting the motor unit and / or the motor adapter to the control unit of the bone fixation device is adjusted. In some embodiments, the length and / or position of the wire is adjusted to minimize interference with the treatment, for example, to minimize the potential interaction between the wire and external objects. In some embodiments, the wire is attached to at least a portion of the bone fixation device, for example, by a wire attachment clip. Alternatively or additionally, wires from two or more sources are attached to the bone fixation device using a wire splitter attachment. In some embodiments, the length of the wire is adjusted by winding excess wire around a wire wrapper attached to the bone fixation device.

[0090] According to some exemplary embodiments, the motor unit coupled to the motor adapter comprises a gear. Optionally, the motor unit comprises an encoder. In some embodiments, the motor unit comprises a user interface configured to generate at least one human-detectable indication, such as an audio and / or visual indication. In some embodiments, the motor unit user interface generates an indication of the activation status of the motor unit, for example, an indication of whether a particular motor unit is activated. In some embodiments, the motor unit user interface generates an audio signal indicating whether a particular motor is operating. In some embodiments, the motor unit user interface comprises at least one LED.

[0091] According to some exemplary embodiments, the motor unit comprises a water-tight housing. In some embodiments, the motor unit comprises a seal between the end of the motor unit that contacts and, for example, interlocks with the motor adapter and the motor unit housing, for example, to prevent water ingress into the electrical circuit within the housing.

[0092] According to some embodiments, the bone fixation device comprises at least two frames and two or more, for example six, struts interconnecting the at least two frames. In some embodiments, the bone fixation device is a hexapod and comprises six struts interconnecting at least two frames. It will also be apparent that the struts as used herein can be connected as a monorail to two spaced pins connected to two parts of the bone or to bone connectors.

[0093] According to some embodiments, a strut of a bone fixation device comprising a linear actuator, a motor adapter coupled to the linear actuator, and a motor unit is provided as a kit. In some embodiments, at least one kit for the bone fixation device is provided. In some embodiments, two, three, four, five, six, seven, or any greater number of kits are provided for the bone fixation device. In some embodiments, the hexapod bone fixation device comprises six kits. In some embodiments, the number of kits is determined by the number of struts included in the bone fixation device.

[0094] In some embodiments, the terms motor and motor unit comprising the motor are interchangeable.

[0095] Before detailing at least one embodiment of the present invention, it is to be understood that the present invention is not necessarily limited to the details of the construction and arrangement of the components and / or methods described in the following description and / or shown in the drawings and / or examples in its application. The present invention is capable of other embodiments or of being carried out or practiced in various ways.

[0096] Exemplary general process for motor unit coupling According to some exemplary embodiments, the motor is coupled to a strut, such as a strut of a bone fixation device, in a process separate from connecting the bone fixation device to the patient's bone. Refer now to FIG. 1 showing a general process for coupling a motor to a strut of a bone fixation device according to some exemplary embodiments of the present invention.

[0097] According to some exemplary embodiments, in block 102, a bone fixation device is connected to a patient's bone. In some embodiments, the bone fixation device comprises at least two spaced-apart frames, at least one rod for each frame extending from the frame to a bone portion, and one or more struts connecting the two frames. In some embodiments, each of the one or more struts comprises a linear actuator configured to vary the distance between the two spaced-apart frames. In some embodiments, in block 102, one or more struts are assembled between the two frames. In some embodiments, the bone fixation device comprises four, five, six, seven, eight, or any fewer or greater number of struts.

[0098] According to some exemplary embodiments, the bone fixation device is connected to the bone in a surgical process, such as a surgery performed in an operating room. In some embodiments, one or more struts are connected to the frame of the bone fixation device during the surgery while the patient is in the operating room. In some embodiments, one or more struts are sterilized prior to assembly to the bone fixation device. In some embodiments, at least some of the struts comprise an integral motor adapter. In some embodiments, the struts and the motor adapter are sterilized prior to assembly.

[0099] According to some exemplary embodiments, in block 104, a motor is coupled to the strut, such as selectively coupled. In some embodiments, the motor is coupled to the motor adapter of the strut. Further, the motor is coupled to the linear actuator of the strut, such as via the motor adapter. In some embodiments, the motor is coupled to the strut after the surgery is completed. Optionally, the motor is coupled to the strut outside the operating room, such as when the patient is at a clinic or at home.

[0100] According to some exemplary embodiments, in block 106, the movement of the motor with respect to the strut is suppressed. In some embodiments, in block 106, the coupling of the motor to the strut, for example, to the linear actuator of the strut, is suppressed. In some embodiments, in block 106, the lateral and / or axial movement of the motor with respect to the strut, for example, with respect to the linear actuator of the strut, is suppressed. In some embodiments, the movement of the motor is suppressed by a motor adapter attached to the strut. In some embodiments, the motor adapter suppresses the movement of the motor by interlocking at least a portion of the motor with the strut, for example, with the linear actuator of the strut.

[0101] According to some exemplary embodiments, in block 108, the motor is actuated. In some embodiments, the motor is actuated when the movement of the motor is suppressed with respect to the strut, for example, with respect to the linear actuator of the strut. In some embodiments, the motor is actuated to extend and / or shorten the length of the linear actuator of the strut. In some embodiments, extending and / or shortening the length of the linear actuator changes the length of the strut and the distance between at least two rings of the bone fixation device. In some embodiments, the motor is actuated according to a treatment plan.

[0102] According to some exemplary embodiments, a motor coupled to a linear actuator moves the linear actuator via a motor adapter of the strut. In some embodiments, the motor moves the linear actuator using, for example, a gear of the motor adapter connected to a gear of the linear actuator. Alternatively, the motor adapter interlocks an end of the motor, for example, an end of the motor including a gear, with the gear of the linear actuator. In some embodiments, interlocking the motor end with the linear actuator gear enables, for example, a direct interaction between the motor and the linear actuator.

[0103] Exemplary Strut Assembly and Kit Referring now to FIGS. 2A-2B, which illustrate a strut assembly including a strut and a motor adapter coupled to the strut, according to some exemplary embodiments of the present invention.

[0104] According to some exemplary embodiments, as shown, for example, in FIG. 2A, an elongate strut 202 includes a linear actuator of the bone fixation device, such as linear actuator 204. In some embodiments, linear actuator 204 is configured to extend and / or shorten the length of the strut along longitudinal axis 205. In some embodiments, linear actuator 204 is axially disposed within strut 202. In some embodiments, the linear actuator includes a screw. In some embodiments, linear actuator 204 includes a gear 206 configured to rotate a screw of linear actuator 204, such as linear actuator 204. In some embodiments, linear actuator gear 206 includes a knob, ring, snap gear, or any rotating element configured to transmit movement to linear actuator 204.

[0105] According to some exemplary embodiments, a motor adapter, such as motor adapter 208, includes a housing 210. In some embodiments, the housing is shaped and sized to connect at least a portion of a strut, such as strut 202. In some embodiments, housing 210 includes one or more openings, such as opening 214, shaped and sized to at least partially fit around a portion of a strut, such as strut 202.

[0106] According to some exemplary embodiments, the support column 204 comprises one or more radially extending portions shaped and sized to interface with, e.g., interlock with, the motor adapter 208. In some embodiments, the motor adapter 208 is connected to the support column 204 by one or more pins and / or screws. In some embodiments, the support column 204 comprises one or more visual indicators, e.g., a window indicating the extent of the extension of the support column. In some embodiments, the motor adapter 208, e.g., the housing 210, is shaped so as not to block one or more visual indicators when the motor adapter is coupled to the support column.

[0107] According to some exemplary embodiments, the motor adapter comprises at least one motor fastener, e.g., a motor restraint 216, configured to enable attachment and detachment of the motor from the motor adapter. Further, the motor restraint 216 inhibits movement of the motor relative to the support column when the motor is attached to the motor adapter. In some embodiments, the motor restraint 216 is configured to inhibit lateral and / or axial movement of the motor relative to the support column.

[0108] According to some exemplary embodiments, the motor adapter 208 comprises a lock 215, e.g., within the housing 210, configured to enable easy locking and unlocking of the motor from the motor restraint 216 and / or from the motor adapter housing 210. In some embodiments, the lock includes an interference lock, a quick release lock, or a snap lock. In some embodiments, the lock comprises a clip. In some embodiments, the lock is separable from the housing, e.g., when the motor is not coupled to the motor adapter.

[0109] According to some exemplary embodiments, the lock 215 includes a motor unit connector configured to connect the motor unit to the housing of the motor adapter. In some embodiments, the motor connector includes one or more protrusions configured to fit into an opening in the housing of the motor adapter and lock the motor connector to the housing. In some embodiments, the motor unit connector is configured to be geometrically interlocked with the motor adapter housing and / or the motor unit. In some embodiments, the motor unit includes a groove, and the motor connector is shaped and sized to fit into the groove when fastening the motor unit to the motor adapter housing.

[0110] According to some exemplary embodiments, the motor restraint 216 includes a manual actuator interface 217, such as a ring, knob, or mating gear. In some embodiments, the manual actuator interface 217 is configured to enable rotation of a linear actuator of a strut coupled to the motor adapter 208.

[0111] According to some exemplary embodiments, the motor restraint 216 includes a socket, such as socket 218, configured to contact at least a portion of the motor, such as the motor end. In some embodiments, the socket 218 is shaped and sized to fit around the motor end.

[0112] According to some exemplary embodiments, as shown, for example, in FIG. 2B, the motor adapter 208 is attached to the strut 202, for example, to form a strut assembly. In some embodiments, the motor adapter 208 is coupled to the strut, for example, selectively coupled to the strut 202. In some embodiments, the motor adapter 208 is coupled to the strut 202 by, for example, one or more connectors and / or fasteners.

[0113] According to some exemplary embodiments, when the motor adapter 208 is coupled to the support column 202, the linear actuator 204 interacts with the gear of the motor adapter 216. In some embodiments, when the motor adapter 208 is coupled to the support column 202, the linear actuator 204 optionally interacts with the manual actuator interface 217 via the linear actuator gear 206. In some embodiments, when the motor adapter 208 is coupled to the support column 202, the movement of the manual actuator interface 217, e.g., the rotation of the interface 217, moves the linear actuator 204.

[0114] According to some exemplary embodiments, as shown, for example, in FIG. 2C, a motor unit 220, e.g., a detachable motor unit, is coupled to the motor adapter 208, e.g., selectively coupled to the motor adapter 208. In some embodiments, the motor 220 is coupled to the motor adapter 208 via the motor restraint 216, e.g., by contacting the socket 218 of the motor restraint 216. In some embodiments, at least a portion of the motor 220, e.g., the motor end, is connected to the restraint 216, e.g., to the socket 218 of the restraint 216. In some embodiments, the restraint 216 inhibits the movement of the motor 220, e.g., the movement of the motor end, relative to the support column 202.

[0115] According to some exemplary embodiments, the motor unit 220 includes a housing, a motor, and a gear extending from the motor unit within the housing. In some embodiments, the motor unit end includes a portion of the motor unit gear extending from the housing. In some embodiments, a portion of the gear extending from the housing has a diameter that is smaller compared to the diameter of the motor unit housing.

[0116] According to some exemplary embodiments, when the motor 220 is coupled to the motor adapter 208, as shown for example in FIG. 2C, at least a portion of the motor 220, such as the motor end, interacts with a linear actuator, such as the gear 206. Optionally, the motor end is interlocked with the gear 206.

[0117] According to some exemplary embodiments, as shown for example in FIG. 2C, the coupling of the motor 220 to the motor adapter 216 releases the manual actuator interface 217 from the motor adapter 208. In some embodiments, the motor end, when coupled, shares the same space in the motor adapter 208, such as the restraint 216, causing the disconnection of the manual actuator interface 217 from the motor adapter 208.

[0118] According to some exemplary embodiments, as shown for example in FIG. 2D, the motor adapter includes a hinge 221 between the restraint 216 and a portion of the housing 210 coupled to the support 202. In some embodiments, the hinge is configured to adjust the angle 122 between the motor 220 and the support 202 while keeping the motor in a restrained state and interacting with the linear actuator. In some embodiments, the hinge includes a hinge lock configured to lock the motor 220 at a selected angle between the motor 220 and the support 202. In some embodiments, the hinge 221 is coupled to move the restraint 216 and / or the motor 220 coupled to the restraint 216 relative to the support at an angle within a range of 0 to 90 degrees, such as 0 to 25 degrees, 0 to 45 degrees, 20 to 50 degrees, 10 to 80 degrees, or any intermediate, smaller, or larger range of values.

[0119] According to some exemplary embodiments, as shown, for example, in FIG. 2E, a motor adapter, such as motor adapter 228, includes a gear 234 in the housing 230 of the motor adapter 228. In some embodiments, the gear 234 is located at or near a motor fastener, such as fastener 236. In some embodiments, the gear 234 is disposed at a location in the motor adapter 228 that enables interaction with a motor coupled to the manual motor interface 217 and / or the fastener 236. In some embodiments, the gear 234 of the motor adapter contacts, for example, directly contacts a linear actuator or a gear of the linear actuator.

[0120] According to some exemplary embodiments, as shown, for example, in FIG. 2F, a motor adapter gear is configured to deliver motion from a motor coupled to the motor adapter to a linear actuator, such as via a linear actuator gear 206. In some embodiments, the motor adapter gear 234 includes at least one interference fit gear. In some embodiments, the motor adapter gear 234 is configured to interact with a linear actuator, such as linear actuator gear 206. Further, the motor adapter gear 234 is configured to interface with the manual motor interface 217 and / or a motor end or a gear of the motor.

[0121] According to some exemplary embodiments, a gear lock, such as gear lock 239, is coupled to a motor adapter, such as motor restraint 236 of the motor adapter, as shown, for example, in FIG. 2G. In some embodiments, gear lock 239 is detachable from the motor adapter. In some embodiments, gear lock 239 is reversibly coupled to a motor adapter, such as a motor restraint. Optionally, at least a portion of gear lock 239 is shaped and sized to be disposed within a socket of the motor restraint. In some embodiments, gear lock 239 is coupled to, and for example interlocks with, gear 206 of linear actuator 204. Alternatively or optionally, gear lock 239 is coupled to, and for example interlocks with, motor adapter gear 234. In some embodiments, gear lock 239 is configured to prevent movement of linear actuator 204 and / or motor adapter gear 234 when the motor is removed from the motor adapter.

[0122] According to some exemplary embodiments, a portion of gear lock 239, such as an end of gear lock 239 extending from motor restraint 236, has a geometric shape that conforms to at least a portion of the motor adapter housing. In some embodiments, the geometric shape of the end of gear lock 239 extending from motor restraint 236, such as an asymmetric geometric shape, interlocks with at least a portion of the motor adapter housing.

[0123] According to some exemplary embodiments, gear lock 239 includes a first end shaped and sized to interlock with motor adapter gear 234 and / or linear actuator gear 206. In some embodiments, a second end of gear lock 239, such as an end of the gear lock extending from motor restraint 236, is configured to interlock with the housing and / or struts of the motor adapter. In some embodiments, by interlocking gear lock 239 with the housing and / or struts of the motor adapter while functionally coupling the linear actuator gear and / or the motor adapter gear, movement of the linear actuator is prevented.

[0124] Exemplary system According to some exemplary embodiments, the control unit is connected to at least some of the strut assemblies, for example, to control and / or monitor the movement of each strut. In some embodiments, monitoring the movement of the struts enables, for example, monitoring the course of treatment and / or making treatment adjustments. In some embodiments, monitoring the movement of the struts is performed from a remote location. Refer now to FIG. 2H showing a control unit connected to one or more strut assemblies according to some exemplary embodiments of the present invention.

[0125] According to some exemplary embodiments, a strut assembly, for example strut assembly 255, comprises a strut, such as strut 202, a motor adapter 208 coupled to the strut 202, and a motor, such as motor 220 coupled to the motor adapter 208. In some embodiments, the strut assembly 255 is connected via a motor to a control unit 244, such as an interface module. Alternatively, the strut assembly 255 is connected to the control unit via a strut adapter. Some potential control and monitoring processes of the control unit, such as an interface module, are described in International Application No. PCT / IB2017 / 057488, which is hereby incorporated by reference in its entirety.

[0126] According to some exemplary embodiments, the control unit 244 comprises a housing 246 configured to be attached to a bone fixation device, such as a ring or an arc of the bone fixation device. In some embodiments, the housing 246 is configured to be attached to the bone fixation device via a housing adapter. In some embodiments, the adapter is configured to be attached to the bone fixation device, for example, by one or more screws or any type of fastener. In some embodiments, the housing of the control unit is configured to be removable from the housing adapter, for example, using an interference lock or a snap-fit lock of the adapter.

[0127] According to some exemplary embodiments, each strut assembly, such as strut assembly 255, is connected to the control unit 244 via a strut assembly connector, such as connector 248, located in the housing 246. In some embodiments, strut assembly 255 is connected to connector 248 via one or more wires, such as one or more cables. In some embodiments, the cable is an electrical cable. In some embodiments, the motor of the strut assembly, such as motor 220, is connected to connector 248, for example by cable 260. Alternatively or additionally, motor adapter 208 is connected to the connector, for example by cable 262. In some embodiments, cables 260 and 262 transmit power and data between strut assembly 255 and control unit 244.

[0128] According to some exemplary embodiments, control unit 244 includes connectors, such as connector 258, for connecting different strut assemblies, such as strut assembly 256, to control unit 244. In some embodiments, each of the connectors of control unit 244 and / or each of the strut assemblies, such as the motor of the strut assembly, is coded, for example using a visual code. In some embodiments, the connectors and the strut assemblies, such as the motor of the strut assembly, are coded with matching or complementary codes, such as numeric codes, color codes, pattern codes. In some embodiments, the code enables connecting a particular strut assembly, such as a particular motor, to a particular connector of the control unit. In some embodiments, the code enables connecting a particular motor to a particular strut motor adapter in a predetermined order.

[0129] According to some exemplary embodiments, control unit 244 comprises a controller 250 connected to each of the connectors of the control unit, such as connectors 248 and 258. In some embodiments, control unit 244 comprises a memory 268 that stores at least one of: one or more treatment protocols, values of at least one treatment parameter, a log file of the control unit, instructions regarding the operation of each of the motors connected to the control unit, and instructions regarding the current length of each of the struts. In some embodiments, at least one parameter includes an operating parameter of each of the motors, such as operating timing, the number of strut extension sessions per hour, per day, per week, and / or per month, the strut extension length per session, and / or the motor operating parameters required for each strut extension session.

[0130] According to some exemplary embodiments, control unit 244 comprises at least one user interface, such as user interface 264. In some embodiments, user interface 264 is configured to deliver human-detectable instructions, such as visual and / or audible instructions, to a patient, a physician, a nurse, or a caregiver of the patient. In some embodiments, controller 250 is configured to monitor proper connection of the motor to the motor adapter and / or proper operation of the motor by measuring the current and / or voltage of the motor.

[0131] According to some exemplary embodiments, if one or more of the motors are not properly connected or are not operating according to a selected treatment plan, controller 250 sends a signal to the user interface to generate a human-detectable instruction. Alternatively or additionally, if a particular motor is not connected to a predetermined connector of the control unit, controller 250 sends a signal to user interface 264 to generate a human-detectable instruction.

[0132] According to some exemplary embodiments, if the value of at least one electrical parameter of the motor is different from a predetermined value or a range of predetermined values, the control system stops the operation of the motor and / or delivers a warning signal. In some embodiments, if the current value of a particular motor is higher or lower than a predetermined value, the control system delivers an alert signal and / or stops the operation of the particular motor and / or stops the execution of the treatment plan. Optionally, the control system re-activates a particular non-operating motor at a later time.

[0133] According to some exemplary embodiments, the control unit 244 includes a communication circuit 270 configured to transmit and receive signals from a remote device, such as a device not physically connected to the control unit 244. In some embodiments, the remote devices include mobile phones, wearable devices, remote computers, tablets, remote servers, information storage clouds. In some embodiments, the communication circuit transmits and receives wireless signals, such as Bluetooth® signals, Wi-Fi signals, infrared signals, or any other wireless signals. According to some exemplary embodiments, the communication circuit 270 and / or the user interface 264 includes a memory storage adapter, such as any type of Universal Serial Bus (USB) adapter, to enable connection of a memory storage device to the control unit 244, for example.

[0134] According to some exemplary embodiments, if the information received from the motor or the motor adapter indicates that the motor is not properly connected or that the progress of the treatment plan is not as desired, the controller 250 sends a signal to the communication circuit to deliver an instruction to the remote device, for example, sends a signal to the remote device to generate an instruction detectable by a human.

[0135] According to some exemplary embodiments, the control unit 244 comprises a power source 266, such as a power supply. In some embodiments, the power source comprises a battery, such as a non-removable battery or a removable battery or a rechargeable battery. In some embodiments, the control unit 244 delivers power to each of the motors via each connector and a cable connecting the control unit 244 and each motor or each motor adapter.

[0136] According to some exemplary embodiments, the control unit 244 sends signals to a user interface of the strut or a user interface of a motor coupled to the strut to generate human-detectable instructions, such as visual and / or audible instructions. In some embodiments, the generated instructions indicate the current state of the strut or the current state of the motor. In some embodiments, the user interface comprises at least one LED indicator and / or a speaker.

[0137] Exemplary detailed process for motor coupling According to some exemplary embodiments, the motor is detachable from a strut of the bone fixation device, such as from a motor adapter of the strut, while the strut remains connected to the bone fixation device. Refer now to FIG. 3 showing a detailed process for coupling, such as selectively coupling, a motor to a strut according to some exemplary embodiments of the present invention.

[0138] According to some exemplary embodiments, the subject is diagnosed at block 302. In some embodiments, the subject is diagnosed with a bone deformation, such as a fracture. In some embodiments, the subject is diagnosed by performing tissue imaging, such as X-ray, computed tomography (CT), ultrasound (US) and / or magnetic resonance imaging (MRI).

[0139] According to some exemplary embodiments, a treatment plan is determined at block 304. In some embodiments, the treatment plan is determined based on the results of the diagnosis performed at block 302. Additionally or alternatively, the treatment plan is determined based on the patient's age, the severity of the bone deformation, and the position and / or orientation of the bone portions that need to be fixed to the bone fixation device. In some embodiments, the parameters of the determined treatment plan include at least one of the number of strut elongation sessions per day, the strut elongation length per elongation session, the timing of each elongation session, and the duration of each elongation session. In some embodiments, additional parameters include the current distance between each bone portion and the desired distance between each bone portion at the end of the treatment.

[0140] According to some exemplary embodiments, a strut is selected at block 306. In some embodiments, the strut is selected according to the determined treatment plan. In some embodiments, the strut is selected based on the current distance between the bone portions and / or the desired distance between the bone portions at the end of the treatment. Additionally or alternatively, the strut is selected according to the patient's anatomical structure.

[0141] Alternatively, the treatment plan is determined, for example, in an operating room after the bone fixation device has been attached to the limb. In some embodiments, the strut is selected before determining the treatment plan. Optionally, the determined treatment plan is adjusted during and / or after attachment of the bone fixation device to the patient's bone.

[0142] According to some exemplary embodiments, at block 308, a motor adapter is coupled to the strut. In some embodiments, the motor adapter is coupled to the strut outside of the operating room, for example, during the strut manufacturing process. Alternatively, the motor adapter is coupled to the strut at a factory and provided as a strut assembly comprising the strut and the motor adapter. In some embodiments, the strut or the motor adapter is sterilized. Alternatively, the strut and the motor adapter are sterilized as a single integrated unit, for example, as a strut assembly.

[0143] According to some exemplary embodiments, the bone fixation device is connected to the patient's bone at block 310. In some embodiments, pins, such as transfixion pins, and / or wires are inserted into the bone. In some embodiments, the pins are connected to an external fixator, such as the frame of the bone fixation device. In some embodiments, the frame comprises a monorail, rod, closed ring, and open ring, or an arcuate frame.

[0144] According to some exemplary embodiments, at least one strut, such as a selected strut, is connected between two external fixators of the bone fixation device. In some embodiments, the at least one strut comprises two, three, four, five, six, seven, eight struts, or any greater number of struts.

[0145] According to some exemplary embodiments, the bone fixation device is attached to a fractured bone. Alternatively, the fracture is generated after the bone fixation device is attached to the bone.

[0146] According to some exemplary embodiments, at block 314, the length of one or more struts is adjusted, for example while attaching the bone fixation device to the bone. In some embodiments, the length of the strut is adjusted to fit between two external fixators, such as between two frames. Alternatively or additionally, the length of the strut is adjusted according to a predetermined starting point of the treatment. In some embodiments, the length of one or more struts is adjusted manually, for example by moving a manual interface of a motor adapter coupled to the strut. In some embodiments, the manual interface is moved, such as rotated, using the hand or finger of a subject, such as a nurse or doctor. Alternatively, the manual interface is moved, such as rotated, using a tool inserted into the manual interface, such as a screwdriver, ratchet, hex key, or any other tool shaped and sized to be placed within the manual interface.

[0147] According to some exemplary embodiments, in block 314, while the end of the strut is connected to the first frame, the length of one or more struts is adjusted. In some embodiments, the length of one or more of the struts is adjusted to enable connection of the strut to the second frame of the bone fixation device.

[0148] According to some exemplary embodiments, at least a part or all of the bone fixation connection in block 310, the connection of the struts in block 312, and the adjustment of the strut length are performed in an operating room, for example, as part of a surgical process.

[0149] According to some exemplary embodiments, in block 318, a motor is coupled to at least some of the struts. In some embodiments, different motors are coupled to each strut. In some embodiments, the motor is coupled to a motor adapter attached to the strut, for example, a linear actuator of the strut. In some embodiments, the motor is coupled to the strut. In some embodiments, the motor is coupled to each of the struts. In some embodiments, a particular motor is coupled to a particular strut, for example, based on a predetermined plan.

[0150] According to some exemplary embodiments, the motor, for example, the motor unit, is identified during and / or after the coupling of the motor. In some embodiments, for example, the motor unit is identified to confirm that the correct motor is connected to the correct strut. In some embodiments, each of the motor units comprises a unique identification code, for example, a barcode and / or RFID. In some embodiments, the identification code is read by a computer, for example, a barcode reader or an RFID reader, respectively.

[0151] According to some exemplary embodiments, in block 320, at least one motor coupled to the strut is connected to a control unit, such as an interface module. In some embodiments, the motor is connected to the control unit before being coupled to the strut. In some embodiments, the control unit comprises the control unit 244 described in FIG. 2H. In some embodiments, the motor is connected to the control unit via a motor adapter of the strut. In some embodiments, the connection of the motor to the control unit includes power delivery between the control unit and the motor, and / or information transmission between the control unit and the motor. In some embodiments, each motor coupled to the strut is connected to a different, optionally specific connector of the control unit, as shown, for example, in FIG. 2H. In some embodiments, the connection of the motor to the wrong connector results in the generation and delivery of an alert signal, such as an alert signal detectable by a human.

[0152] According to some exemplary embodiments, in block 322, each of the motors coupled to the strut is actuated. In some embodiments, the motors are actuated according to a treatment plan determined in block 304. Alternatively or additionally, the motors are actuated according to a predetermined actuation plan for each motor. Optionally, the motors are actuated synchronously. In some embodiments, the motors are actuated based on signals received from the control unit.

[0153] Exemplary Motor Coupling to the Strut Now, refer to FIGS. 4A - 4C showing an assembly or kit of a strut, a motor adapter, and a motor according to some exemplary embodiments of the present invention.

[0154] According to some exemplary embodiments, a strut assembly, such as strut assembly 402, includes an elongate strut 404 and a motor adapter 406 coupled to the strut 404. In some embodiments, the motor adapter 406 is fixedly coupled to the strut 404, for example, during the manufacturing process of the strut 404. In some embodiments, the motor adapter includes a motor restraint 407 configured to connect a motor to the motor adapter and inhibit movement of the motor relative to the strut. In some embodiments, the motor restraint includes a socket 409 shaped and sized to receive at least a portion of the motor, such as an end of the motor.

[0155] According to some exemplary embodiments, the strut 404 includes a linear actuator, such as a linear actuator disposed within the strut 404. In some embodiments, the linear actuator includes a screw.

[0156] According to some exemplary embodiments, a kit includes a strut assembly 402 and a motor 408, such as an electric motor. In some embodiments, at least a portion of the motor, such as motor end 411, is shaped and sized to interact with, for example, connect to, the motor adapter.

[0157] According to some exemplary embodiments, the motor 408 includes at least one cable connector 411 configured to be connected to a cable, such as an electrical cable. In some embodiments, the cable connects the control unit to the motor 408, for example, as described in FIG. 2H. In some embodiments, the cable connector, such as the cable connector, is disposed near an end of the motor on the opposite side of the motor end that interacts with the motor adapter. Alternatively or additionally, the cable connector is located at a distance from an extending portion of the strut, for example, to ensure that the distance between the motor and the control unit remains constant.

[0158] According to some exemplary embodiments, for example, as shown in FIGS. 4B and 4C, the cable connector is positioned at a distance of at least 5 cm, such as 6 cm, 7 cm, 10 cm, or any intermediate value, smaller value, or larger value, relative to the movable part of the motor or the support column. For example, to minimize the interaction and / or distance between the cable connected to the cable connector and the movable part of the motor or the support column.

[0159] According to some exemplary embodiments, the support column 404 includes an indicator, such as an external indicator 413, configured to provide a visual indication regarding the extended length of the support column. In some embodiments, the indicator includes a ruler.

[0160] According to some exemplary embodiments, the kit includes one or more motor fasteners, such as fastener 410, configured to fasten and / or lock the motor to the support column and / or the motor adapter housing. In some embodiments, the one or more fasteners include a clip, a band, or an elastic band.

[0161] According to some exemplary embodiments, for example, as shown in FIGS. 4B and 4C, when coupled to the motor adapter, the assembly of the support column, the motor adapter, and the motor are fastened together, for example, during treatment, to prevent unwanted disconnection of the motor and / or the motor adapter from the support column.

[0162] Now, refer to FIGS. 5A and 5B showing the assembly components and the interaction between the motor, the motor adapter, and the support column according to some exemplary embodiments of the present invention.

[0163] According to some exemplary embodiments, the strut 404 comprises an elongated body 419 having a longitudinal axis 420, a first end 422, and a second end 424. In some embodiments, the first end 422 of the strut is a stationary end configured not to move relative to the strut body 419. In some embodiments, the second end 424 of the strut 404 is a moving end, such as an extending end, configured to move relative to the strut body 404. In some embodiments, the motor adapter comprises one or more openings that enable passage of the strut body. In some embodiments, the openings in the motor adapter are circular and are configured to rotate the motor adapter around the strut body.

[0164] According to some exemplary embodiments, as shown, for example, in FIG. 5B, the strut 404 comprises a linear actuator, such as a strut screw 425, disposed within the strut body. In some embodiments, the strut comprises at least two connectors, such as mechanical connectors, at different ends of each strut. In some embodiments, at least one connector, such as a joint 426, is connected to the body 419 of the strut 404 at the stationary end 422. In some embodiments, at least one different connector, such as a joint 428, is connected to an extending portion 430 of the strut screw 425 at the extending end 424 of the strut 404. In some embodiments, the joint 426 and / or the joint 428 is an external fixed ring joint, such as an M7 or M5 ring joint. Optionally, one or more of the joints comprise a ball, such as a titanium ball 432. In some embodiments, at least two connectors of the strut, such as the joints 426 and / or 426, are configured to connect the strut to a bone fixation device frame, such as a ring. In some embodiments, the strut is coupled to two spaced-apart frames of the bone fixation device using joints, and each joint connects a different end of the strut to a different frame.

[0165] According to some exemplary embodiments, the support column 404 includes a linear actuator transmission member, such as a support column gear 434. In some embodiments, the support column gear 434 is located at a distance less than 5 cm, such as less than 4 cm, less than 2 cm, less than 1 cm, or any intermediate, smaller, or larger distance, from the extending portion 430 of the support column. In some embodiments, the support column gear is coupled to, such as fixedly coupled to, the linear actuator 425. In some embodiments, at least a portion of the outer surface of the linear actuator includes threads. In some embodiments, the support column gear 434 is coupled to the threads of the linear actuator 425, such as interlocks with the threads of the linear actuator 425. In some embodiments, the support column gear 434 includes a threaded nut that interlocks with threads, such as helical threads around the outer surface of the linear actuator. In some embodiments, the linear actuator is formed as a cylinder having male threads along at least 50% of the length of the linear actuator, such as at least 70%, at least 80%, or any intermediate, smaller, or larger percentage value.

[0166] According to some exemplary embodiments, the motor adapter 407 includes a housing 442 attached at least partially around the support column 404, such as around the support column gear 434. In some embodiments, the motor adapter 407 includes a motor adapter gear 444 within the housing 442. In some embodiments, the motor adapter gear 444 includes a mating gear. In some embodiments, the motor adapter gear 444 interlocks with the support column gear 434 when the motor adapter 407 is coupled to the support column 404.

[0167] According to some exemplary embodiments, the motor adapter includes a motor fastener 446 in a housing 442 configured to receive at least a portion of the motor and to inhibit movement, e.g., to inhibit lateral and / or axial movement of the motor portion relative to the support post, such as a motor restraint. In some embodiments, the motor fastener includes a socket shaped and sized to fit an end portion, e.g., a rotating end portion of the motor. In some embodiments, the socket is coupled to a motor adapter gear 444 and configured to transmit rotational movement of the motor end portion to the motor adapter gear 444 while optionally inhibiting movement of the motor end portion, e.g., during rotation of the motor end portion.

[0168] According to some exemplary embodiments, as shown, for example, in FIG. 5B, a rotational force is transmitted from a motor 408 to a linear actuator 425 near an extending portion 430 of a support post 404.

[0169] According to some exemplary embodiments, as shown, for example, in FIG. 5B, the motor includes an electric motor 450, such as a direct current (DC) motor, connected to a motor gear 452. In some embodiments, the motor gear shaft is coupled to a motor fastener 446, e.g., to a socket of the motor fastener 446. In some embodiments, the coupling of the motor gear shaft to the motor fastener 446 enables engagement with a motor adapter gear 444 coupled to a linear actuator gear 434, for example.

[0170] According to some exemplary embodiments, the motor 407 includes at least one positioning sensor, such as a positioning sensor 454. In some embodiments, the positioning sensor is configured to monitor the extension length of the support post based on movement of the motor rotation.

[0171] According to some exemplary embodiments, for example, as shown in FIGS. 5B-5D, a pin 431 passing through the linear actuator 425 and at least one slit 433 in the body 419 prevent rotation of the linear actuator 425 relative to the body 419 when the gear 434 rotates.

[0172] Now, refer to FIGS. 6A-6D showing an add-on motor adapter selectively coupled to a support column according to some exemplary embodiments of the present invention.

[0173] According to some exemplary embodiments, a motor adapter, such as motor adapter 604, is configured to be selectively coupled to a support column, such as support column 602. In some embodiments, the motor adapter 604 includes a transmission member, such as gear 608. In some embodiments, the gear 608 includes a mating gear. In some embodiments, the housing 606 of the motor adapter 604 is shaped and sized to align and attach the gear 608 to the support column linear actuator gear 610, for example, to align and interlock the gear 608 of the motor adapter 604 with the support column gear 608. In some embodiments, when the gear 608 interlocks with the linear actuator gear 610, one or more fasteners, such as fastener 612, lock the position of the motor adapter 604 relative to the support column 602. In some embodiments, the one or more fasteners 612 include a clip or band. Alternatively, the one or more fasteners are removed to enable attachment of the motor adapter 604 to the support column 602, for example, as shown in FIG. 6D, and include a portion of the housing 606 configured to be re-engaged with the housing 606 for fixedly attaching the motor adapter 604 to the support column 602.

[0174] According to some exemplary embodiments, for example, as shown in FIG. 7A, the motor 408 is sealed against water penetration. In some embodiments, the motor 408 includes a seal 702. In some embodiments, the seal is disposed between the rotating end of the motor extending from the motor housing 704 and the inner lumen of the housing. In some embodiments, sealing the motor against water enables at least IP67 water protection, for example, allowing a patient wearing the bone fixation device to submerge the bone fixation device in water, for example, during water rehabilitation therapy.

[0175] According to some exemplary embodiments, further, for example, as shown in FIG. 7B, the outer surface 704 of the motor 408 is smooth, for example, to allow for easy wiping of the surface, for example, the opening 706. In some embodiments, sealing the motor against water enables, for example, easy maintenance and cleaning of the motor.

[0176] According to some exemplary embodiments, for example, as shown in FIG. 7B, the motor fastener 407, for example, the socket 409 of the motor fastener, includes at least one drain hole 706 to allow for drainage, for example, from the socket 409.

[0177] According to some exemplary embodiments, for example, as shown in FIGS. 7C and 7D, the assembly 701 between the motor adapter 406 and the motor 408 fits around a small post, for example, the post 720. In some embodiments, the length of the assembly is shorter than the length between the two ends of the post 720. In some embodiments, the maximum length of the assembly when the linear actuator is at its minimum length is in the range of 6 cm to 25 cm, for example, 6 cm to 8 cm, 10 cm to 12 cm, 18 cm to 20 cm, or any intermediate, shorter, or longer assembly length.

[0178] According to some exemplary embodiments, as shown, for example, in FIG. 7C, the housing of the motor adapter 406 comprises an opening 732 or window that aligns with an indicator, such as a strut gauge 734, when the motor adapter 406 is attached to the strut 720. In some embodiments, the opening 732 enables visualization of an indicator that indicates the extended length of the strut. In some embodiments, the opening is disposed between two or more connection points of the motor adapter to the strut, such as connection points 728 and 730.

[0179] According to some exemplary embodiments, as shown, for example, in FIG. 7D, the strut assembly 701 is attached to bone fixation device rings, such as rings 740 and 742. In some embodiments, the rings have diameters in the range of 80 mm to 300 mm, such as 80 mm to 120 mm, 100 mm to 150 mm, 130 mm to 200 mm, 190 mm to 250 mm, 200 mm to 300 mm, or any intermediate, smaller, or larger range of values. Optionally, the assembly 701 can fit onto the struts of the bone fixation device if the angle between the rings is up to 60 degrees, such as up to 55 degrees, up to 50 degrees, or any intermediate, smaller, or larger angle between the two rings. Optionally, the assembly 701 can fit onto struts that are connected closer to the inner diameter of the rings.

[0180] According to some exemplary embodiments, as shown, for example, in FIG. 7E, the assembly 701 is shaped and sized to be attached to struts of different lengths by, for example, one or more motor adapter housing openings and / or one or more connectors of the motor adapter housing. In some embodiments, one or more of the openings of the motor adapter housing have an inner diameter that is larger than the outer diameter of the strut. In some embodiments, the inner diameter of one or more of the openings is larger than the outer diameter of the strut by up to 3 mm, such as up to 2 mm, up to 1 mm, or any intermediate, smaller, or larger value. In some embodiments, one or more of the motor adapter openings form channels shaped to receive the strut.

[0181] According to some exemplary embodiments, assembly 701 is shaped and sized to be attached to a long strut 721, for example, having a minimum length in the range of 160 mm to 190 mm in the closed state, such as 160 mm to 170 mm, 165 mm to 180 mm, 175 mm to 190 mm, or any intermediate, smaller, or larger range of values. In some embodiments, assembly 701 is shaped and sized to be attached to an intermediate strut 723, for example, having a minimum length in the range of 110 mm to 130 mm in the closed state, such as 110 mm to 120 mm, 115 mm to 130 mm, or any intermediate, smaller, or larger range of values. In some embodiments, assembly 701 is shaped and sized to be attached to a short strut 725, for example, having a minimum length in the range of 80 mm to 110 mm in the closed state, such as 80 mm to 100 mm, 90 mm to 100 mm, 95 mm to 110 mm, or any intermediate, smaller, or larger range of values. In some embodiments, different assemblies are used with different strut sizes.

[0182] Change in the angle between the motor adapter and the bone fixation device According to some exemplary embodiments, a motor adapter coupled to a strut is configured to rotate about the axis of the strut to adjust the angle, for example, between the motor adapter and the bone fixation device, such as between the motor adapter and at least one frame of the bone fixation device. In some embodiments, the angle is adjusted between the motor adapter coupled to the strut and at least one frame connected to the strut. In some embodiments, the angle between the motor adapter and the bone fixation device is changed, for example, to reduce the portion of the motor adapter extending from the outer periphery of the bone fixation device. Refer to FIGS. 7F - 7K showing the adjustment of the angle between the motor adapter and the bone fixation device, such as the frame of the bone fixation device, according to some exemplary embodiments of the present invention.

[0183] According to some exemplary embodiments, as shown in FIGS. 7F and 7G for example, a motor adapter 406 connected to a strut 720 is configured to rotate about the axis of the strut, for example, to vary the angle between the motor adapter and the frame of the bone fixation device, such as frame 740. In some embodiments, a rotational lock 739 in the strut, such as a locking pin, is released to enable rotation of the strut 720a about the longitudinal axis of the strut. In some embodiments, rotation of the strut 720 rotates the motor adapter 406 coupled to the strut 720. In some embodiments, when a desired angle between the motor adapter 406 and the bone fixation device, such as frame 740, is reached, the rotational lock 739 is locked to prevent undesired rotation of the motor adapter. As used herein, rotation of the motor adapter refers to rotation of the strut assembly comprising the motor adapter and the strut about the longitudinal axis of the strut.

[0184] According to some exemplary embodiments, as shown in FIG. 7H for example, the angle 750 between the horizontal axis 749 of the motor adapter 406 or the strut assembly and the tangent 752 of the frame 740 of the bone fixation device, such as frame 740, is in the range of 0 to 90 degrees, such as 0 to 30 degrees, 20 to 40 degrees, 50 to 90 degrees, or any intermediate, smaller, or larger range of angular values.

[0185] According to some exemplary embodiments, as shown in FIG. 7I for example, a strut assembly 754 includes a motor adapter 756 coupled to a strut 758. In some embodiments, the strut 758 includes an elongated body having a longitudinal axis 760. In some embodiments, the motor adapter 756 coupled to the strut 758 optionally has a cross-section or a horizontal axis 762 that is perpendicular to the longitudinal axis 760. FIG. 7I shows a cross-section 755 along the horizontal axis 762.

[0186] According to some exemplary embodiments, as shown, for example, in FIG. 7J, at least one ring of the bone fixation device, such as ring 759, is connected to two or more struts, such as a strut assembly. In some embodiments, the motor adapter 756 of the strut assembly 754 or the strut assembly 754 as a single unit is rotated about axis 760 and locked at an angle 750 between the horizontal axis 756 and a tangent 752, such as a tangent plane perpendicular to the ring 759. In some embodiments, the angle 750 ranges from about 0 to 90 degrees. In some embodiments, as shown, for example, in FIG. 7J, the angle is 90 degrees. In some embodiments, when the angle is 90 degrees, the motor adapter extends maximally from the outer periphery of the bone fixation device.

[0187] According to some exemplary embodiments, as shown, for example, in FIG. 7K, at least some of the motor adapter or the strut assembly are rotated, for example, to reduce a portion of the motor adapter extending from the outer periphery of the bone fixation device. In some embodiments, reducing the extending portion of the motor adapter can, for example, prevent contact between an external object around the patient and one or more of the motor adapter, a motor coupled to the motor adapter, the motor, or at least one cable connecting the motor or the motor adapter to a control unit.

[0188] According to some exemplary embodiments, as shown, for example, in FIG. 7K, the motor adapter 756, or the strut assembly including the motor adapter, is locked at an angle 764 less than 90 degrees, such as less than 45 degrees, less than 30 degrees, less than 10 degrees, less than 5 degrees.

[0189] Exemplary strut replacement during treatment According to some exemplary embodiments, it may be necessary to replace a strut during treatment. Here, refer to FIGS. 8A - 8C showing the replacement of a strut during treatment according to some exemplary embodiments of the present invention.

[0190] According to some exemplary embodiments, as shown, for example, in FIG. 8A, motor 806 is removed from motor adapter 804 coupled to support 802. In some embodiments, motor 806 is removed from motor adapter 804 by releasing at least one fastener, such as fastener 808 that fastens motor 806 to motor adapter 804. In some embodiments, the fastener comprises a clip configured to be attached to an opening 801 in the motor adapter housing. In some embodiments, fastener 808 is released using tool 810. In some embodiments, tool 810 has a unique geometric or structural shape, for example, to enable release of fastener 808. In some embodiments, using a tool with a unique geometric shape makes it possible to prevent unwanted removal of the motor by the patient. In some embodiments, the motor is removed at a clinic or medical facility, for example, when replacing the support.

[0191] According to some exemplary embodiments, as shown, for example, in FIG. 8B, when motor 806 is removed from motor adapter 804, support 802 having the motor adapter is replaced. Alternatively, motor adapter 804 is released from support 802 and only support 802 is replaced.

[0192] According to some exemplary embodiments, as shown, for example, in FIG. 8C, when the support and motor adapter are replaced with support 810 and motor adapter 812, motor 806 used with the previous support is coupled to motor adapter 812.

[0193] According to some exemplary embodiments, motor 806 is selectively coupled to the motor adapter, for example, without using a tool, by placing a fastener, such as an elastic clip, around the motor and within opening 801. In some embodiments, releasing fastener 808 from the opening requires a tool, for example, to prevent unwanted release of the motor during treatment.

[0194] Exemplary Manual Strut Adjustment According to some exemplary embodiments, a motor adapter coupled to a strut is configured to enable manual movement of a linear actuator of the strut, for example, during strut adjustment and / or calibration. Referring now to FIGS. 9A - 9G, which illustrate a motor adapter manual interface according to some exemplary embodiments of the present invention.

[0195] According to some exemplary embodiments, a motor adapter 902 coupled to a strut 904 includes a motor adapter manual interface, such as manual interface 906. In some embodiments, a motor fastener of the motor adapter, such as motor restraint 908, includes the manual interface 906. In some embodiments, the manual interface 906 includes an inner portion 930 shaped and sized to be disposed at least partially within the motor restraint 908, such as within a socket of the motor restraint. Further, an outer portion 932 of the manual interface 906 is configured to enable manual movement of the manual interface.

[0196] According to some exemplary embodiments, an outer portion 932 of the manual interface 906, such as the outer portion 932 of the manual interface 906 extending from the motor adapter as shown in FIG. 9E, is shaped to enable rotation of the manual interface by a user's hand. In some embodiments, the outer portion 932 of the manual interface is circular and optionally includes a plurality of ridges or protrusions shaped to increase friction with the user's hand.

[0197] According to some exemplary embodiments, an inner portion 930 of the manual interface 906 is configured to contact a gear, such as gear 916 of the motor adapter 902. In some embodiments, the manual interface 906, such as the inner portion 930, is interlocked with the gear 916, as shown, for example, in FIG. 9E.

[0198] According to some exemplary embodiments, for example, as shown in FIGS. 9B and 9D, the coupling of a motor, such as motor 912, to a motor adapter 902 disengages a manual interface 906 from the motor adapter 902. In some embodiments, the manual interface 906 and the motor 912, for example, the end of the motor 912, removably couple a restraint 908, such as a gear 916. In some embodiments, the manual interface 906 and the motor 912, for example, the motor end, are interchangeably interlocked with the gear 916.

[0199] Exemplary system assembly process According to some exemplary embodiments, the motor is coupled to a bone fixation device, such as a strut of the bone fixation device, after the surgery for fixing the bone fixation device to the bone is completed. In some embodiments, the motor is coupled to the strut outside the operating room, such as in a clinic. In some embodiments, coupling the motor separately from the surgery outside the operating room allows, for example, sterilizing only the strut using a motor adapter without the need to sterilize the motor. Additionally or alternatively, coupling the motor separately from the surgery outside the operating room allows, for example, shortening the time required in the operating room. Here, refer to FIGS. 10A - 10D showing the assembly process of a bone fixation system according to some exemplary embodiments of the present invention.

[0200] According to some exemplary embodiments, for example, as shown in FIGS. 10A and 10B, the bone fixation device 1002 is connected to the bone during surgery in the operating room. In some embodiments, the bone fixation device 1002 includes a strut, such as a strut 1006 interconnecting two frames 1003 and 1005 of the bone fixation device. In some embodiments, the frames are closed frames, such as closed circular frames. Alternatively, the frames are open frames, such as arcuate frames. Alternatively, the frames include any plate or bar connected to bone pins or nails extending from the bone.

[0201] According to some exemplary embodiments, each of the struts 1006 includes a motor adapter 1008 coupled to a linear actuator of the strut. In some embodiments, in the operating room, each motor adapter includes a manual interface 906, or at least some of the motor adapters include a manual interface 906. In some embodiments, for example, as shown in FIG. 10B, in the operating room, an expert, such as a surgeon, doctor, or nurse, manually adjusts the length of each strut using the manual interface 906, for example, as described in FIGS. 9A-9D. In some embodiments, the length of each strut is adjusted in the operating room according to the distance between two frames and the orientation of the frames relative to each other.

[0202] According to some exemplary embodiments, for example, as shown in FIGS. 10C and 10D, outside the operating room, such as in a clinic or the patient's home, motors, such as motors 1012 and 1014, are coupled to the motor adapters. In some embodiments, the coupling of the motors disengages the manual interface 906 from each motor adapter. Further, an interface module, such as a control unit 1018, is attached to a bone fixation device, such as at least one frame of the bone fixation device. Further, the control unit is connected to each of the motors, for example, electrically connected, via at least one cable, such as cable 1016 that connects motor 1012 to control unit 1018.

[0203] According to some exemplary embodiments, each of the motors includes a visual code used for motor identification, for example, as a motor ID code. In some embodiments, the motor ID code enables, for example, placing the motors in a predetermined location and order, optionally, in different motor adapters. In some embodiments, the control unit 1018 uses the motor ID code to monitor and / or adjust the operation of a specific motor. In some embodiments, after connecting the control unit 1018 to the motor and optionally connecting the cable to the external fixation device components, at least one treatment program stored in the memory of the control unit is started. Alternatively, at least one of the treatment programs is loaded into the control unit memory from an external device, such as an external computer, a remote device, or a mobile device. In some embodiments, the operating parameters of one or more of the motors are loaded into the memory of the control unit, for example, the memory 268 shown in FIG. 2H. In some embodiments, the control unit 1018 operates each of the motors separately and / or synchronously according to the information stored in the memory.

[0204] According to some exemplary embodiments, as shown, for example, in FIG. 10E, coupling the motors outside the operating room and connecting the control unit enables sterilizing only the mechanical components of the bone fixation device, such as the motor adapters 1008 and the struts 1006, while keeping the control system 1030, which includes the control unit 1014 and two or more motors, such as motors 1012 and 1014, non-sterile. In some embodiments, the struts and motor adapters are configured to be sterilized using an autoclave. In some embodiments, two or more motors, such as motors 1012 and 1014, are connected to the control unit 1018 via a cable splitter box 1020, as shown, for example, in FIG. 10E.

[0205] Exemplary System Assembly on a Bone Fixation Device According to some exemplary embodiments, a system for monitoring and / or controlling a bone fixation device is attached to the bone fixation device in a manner that enables easy installation using one hand. Further, the control system is positioned within the view of the patient or caregiver, for example, to enable visualization of one or more indicators on the control unit by the patient and / or caregiver. Additionally or optionally, the control system is positioned to minimize interference by external objects surrounding the patient to system components. Here, refer to FIGS. 11A - 11G showing the system assembly onto the bone fixation device according to some exemplary embodiments of the present invention.

[0206] According to some exemplary embodiments, for example, as shown in FIGS. 11A and 11B, the control unit 1018 is attached to the front end of the bone fixation device, optionally to the topmost frame of the bone fixation device. Further, a panel of the control unit 1018, including one or more visual indicators, for example, the upper panel, is oriented or tilted to face the patient's eyes.

[0207] According to some exemplary embodiments, the system is shaped, sized, and / or attached to the bone fixation device 1002 so as not to extend more than 7 cm from the bone fixation device 1002, for example, more than 5 cm, more than 3 cm, or any intermediate value, smaller value, or larger value. In some embodiments, a cable, for example, a cable connecting a motor to the control unit 1018, is attached to the bone fixation device to minimize extension of the cable beyond the outer periphery of the bone fixation device. Additionally or alternatively, the cable is directed towards the rear end of the bone fixation device.

[0208] According to some exemplary embodiments, for example, as shown in FIGS. 11C and 11D, cables from two or more motors are connected via a cable splitter box, such as box 1120. In some embodiments, for example, as shown in FIG. 11C, box 1120 is attached to the frame of the bone fixation device. In some embodiments, box 1120 is attached to one or more openings in the frame by attachment pins 1121 of box 1120.

[0209] According to some exemplary embodiments, for example, as shown in FIGS. 11C and 11D, the cables are fastened to the bone fixation device, for example, by one or more cable fasteners 1122. In some embodiments, one or more cable fasteners are introducible through one or more openings in the bone fixation device, such as openings in the frame of the bone fixation device. In some embodiments, in order to prevent the excess length of the cable from loosening, one or more of the cables are wound around the bone fixation device, for example, a cable wrapper attached to the frame of the bone fixation device, such as an internal cable wrapper 1126 or an external cable wrapper 1124. In some embodiments, when the cable is loose, for example, when using a small external fixing ring, cable wrapper 1124 or 1126 is used to enable winding the loose cable around cable wrapper 1124 or 1126.

[0210] According to some exemplary embodiments, for example, as shown in FIG. 11E, the length of the cable between the motor and box 1120 is adjusted to fit within long struts, such as long strut 1140, intermediate strut 1142, and small strut 1144.

[0211] According to some exemplary embodiments, for example, as shown in FIGS. 11F and 11G, the control unit 1018 is detachable from the bone fixation device, for example, from the frame of the bone fixation device. In some embodiments, the control unit ring interface 1150 is fixedly attached to the frame using one or more screws 1152. In some embodiments, the control unit is configured to couple to, for example, be attached to, the ring interface 1150 via at least one quick release lock, such as a snap lock or any interference lock configured to easily lock and unlock the control unit 1014 from the ring interface 1150. In some embodiments, the quick release lock is part of the ring interface 1150 and / or the control unit 1018.

[0212] Exemplary positioning sensor According to some exemplary embodiments, the control unit connected to each of the motors monitors the axial elongation length of each of the struts of the bone fixation device, for example, by measuring the rotational position of each motor. Refer now to FIGS. 12A - 12C, which illustrate motor positioning sensors according to some exemplary embodiments of the present invention.

[0213] According to some exemplary embodiments, the motor 1202 of the bone fixation device includes a gear 1204 coupled to, for example, axially coupled to, a motor 1206, such as a DC motor. In some embodiments, the gear 1204 rotates a motor end 1207 configured to interact, for example, to interlock with the gear of a motor adapter. In some embodiments, the motor 1202 includes at least one positioning sensor 1210.

[0214] According to some exemplary embodiments, the positioning sensor is configured to record the rotation of the motor at least three times, such as at least four times, at least five times, or any lesser or greater number of readings during the rotation of the motor 1206. In some embodiments, a control unit connected to the motor measures the axial positioning of the support based on the positioning sensor readings. In some embodiments, the control unit measures the axial positioning of the support with a resolution of at least 0.3 μm, such as 0.5 μm, 0.6 μm, or any intermediate, smaller, or larger value. In some embodiments, the positioning sensor comprises a rotating magnet 1218 and one or more Hall sensors, such as sensors 1220 and 1222. In some embodiments, the positioning sensor comprises two, three, four, five, six, seven, eight, or any greater number of Hall sensors.

[0215] Exemplary gear lock According to some exemplary embodiments, a gear lock is attached to a motor adapter coupled to a support when the motor is snap-coupled to the motor adapter, for example, to prevent movement of a linear actuator of the support. Reference is now made to FIGS. 13A-13F showing a gear lock, and the interaction of the gear lock and the motor adapter, according to some exemplary embodiments of the present invention.

[0216] According to some exemplary embodiments, the motor adapter 1302 is coupled to the support 1306. In some embodiments, the motor adapter comprises a motor restraint 1304 that is shaped and sized to receive and retain a portion of the motor unit. In some embodiments, for example, when the motor unit is removed from the motor adapter 1302, the gear lock 1308 is coupled to the motor restraint 1304. In some embodiments, the coupling of the gear lock 1308 to the motor restraint 1304 prevents movement, such as reverse movement or crushing of a linear actuator of the support 1306.

[0217] According to some exemplary embodiments, for example, as shown in FIGS. 13B and 13C, at least a portion of the gear lock 1308 is inserted into the motor restraint 1304 and interacts with the gear 1310 of the motor adapter. Optionally, a portion of the gear lock 1308, for example, disposed within the motor restraint 1304, is interlocked with the gear 1310. In some embodiments, the interlocking of the gear lock 1308 with the gear 1310 prevents the movement of the strut linear actuator, for example, the movement of the linear actuator gear 1312 coupled to the motor adapter gear 1310.

[0218] According to some exemplary embodiments, for example, as shown in FIG. 13D, the gear lock 1308 includes a first end 1314 shaped and sized to fit into the motor restraint 1304, for example, into the socket 1318 of the motor restraint 1304. In some embodiments, the maximum width of the first end is smaller than the inner width or inner diameter of the socket 1318. Additionally or alternatively, the first end I is shaped and sized to interlock with the gear 1310, for example, the mating teeth of the gear 1310. In some embodiments, the first end of the gear lock includes one or more bulges or protrusions configured to penetrate into an opening, for example, a complementary or matching opening, in the gear 1310, for example, the mating teeth of the gear 1310.

[0219] According to some exemplary embodiments, the second end 1316 of the gear lock 1308 extends from the motor restraint 1304, for example, from the socket 1318 of the motor restraint 1304. In some embodiments, the second end 1316 of the gear lock 1308 is shaped and sized to interact, for example, interlock with the housing of the motor adapter, for example, the housing 1320. In some embodiments, the gear lock 1308 is configured to interlock simultaneously with, for example, the motor adapter gear 1310 and the motor adapter housing 1320 to prevent the movement, for example, the rotational movement, of the motor adapter gear 1310.

[0220] According to some exemplary embodiments, the second end 1316 of the gear lock 1308 has a geometric shape configured to interact with at least one protrusion or geometric shape of the housing 1320. In some embodiments, the second end 1316 interacts with a geometric shape of the housing, such as a complementary geometric shape of the housing, to prevent movement of the gear lock 1308 relative to the housing, for example.

[0221] During the term of the patent maturing from this application, many related struts and bone fixation devices are expected to be developed, and the scope of the terms struts and bone fixation devices is intended to include, a priori, all such new technologies.

[0222] As used herein with respect to a quantity or value, the term "about" means "within ±10%".

[0223] The terms "comprises", "comprising", "includes", "including", "has", "having" and their cognates mean "including but not limited to".

[0224] The term "consisting of" means "including and limited to".

[0225] The term "consisting essentially of" means that a composition, method or configuration may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not substantially change the basic and novel characteristics of the claimed composition, method or structure.

[0226] As used herein, unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural referents. For example, the term "compound" or "at least one compound" may include plural compounds, including mixtures thereof.

[0227] Throughout this application, embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as the individual numerical values within that range. For example, a description of a range such as "1 to 6" should be considered to specifically disclose sub-ranges such as "1 to 3," "1 to 4," "1 to 5," "2 to 4," "2 to 6," "3 to 6," etc., as well as the individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0228] When a numerical range is recited herein (e.g., "10 - 15," "10~15," or any number of pairs concatenated by these or other such range notations), it is meant to include any number (fractional or integer) within the recited range, including the recited range limits, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first recited number and a second recited number, and "range / ranging / ranges from" a first recited number "up to," "until," or "through" a second recited number are used interchangeably herein, and this is meant to include the first and second recited numbers, as well as all fractions and integers therebetween.

[0229] Unless otherwise indicated, the numbers and any range of numbers used herein are approximations within the precision of reasonable measurement and rounding errors as would be understood by one of ordinary skill in the art.

[0230] As used herein, the term "method" means a way, means, technique and procedure for accomplishing a given task, including, but not limited to, any way, means, technique and procedure that is known or readily developed as a well-known way, means, technique and procedure by practitioners in the fields of chemistry, pharmacology, biology, biochemistry and medicine.

[0231] As used in the present invention, the term "treating" includes suppressing the progression of a medical condition, substantially inhibiting it, slowing it down, or reversing it, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the appearance of the clinical or aesthetic symptoms of a condition.

[0232] Certain features of the present invention are described in the context of separate embodiments for clarity, but it is understood that these may also be presented in combination in a single embodiment. Conversely, the various features of the present invention are described in the context of a single embodiment for brevity, but these may also be provided separately, or in any suitable partial combination, or in any other described embodiment of the present invention, as may be preferably provided. Specific features described in the context of various embodiments should not be considered essential features of those embodiments, unless the embodiments are inoperable without those elements.

[0233] The present invention has been described in connection with its particular embodiments, but it is obvious that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0234] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. It should be noted that the citation or identification of any reference document in this application should not be construed as an admission that such a document is available as prior art for the present invention. To the extent that section headings are used, they should not necessarily be construed as limiting. Additionally, any priority document(s) of this application are hereby incorporated by reference in their entirety.

[0235] 〔Embodiments〕 (1) A kit comprising a strut of a bone fixation device including a fixed portion and an extending portion, the strut comprising a linear actuator mechanically connected to the extending portion; at least one motor adapter coupled to the linear actuator, the motor adapter comprising a motor fastener; at least one motor unit selectively detachable from the motor fastener, the motor unit being functionally coupled to the linear actuator and configured to axially extend the extending portion of the strut; and the kit, wherein the motor fastener is shaped and sized to receive a portion of the motor unit. (2) The kit according to embodiment 1, wherein the motor fastener is shaped and sized to receive an end of the motor unit and to suppress lateral movement of the end of the motor unit. (3) The kit according to embodiment 1 or 2, wherein the motor fastener comprises a socket shaped to receive the motor end. (4) The kit according to embodiment 3, wherein the motor unit comprises a housing, a motor, and a gear extending from the motor unit within the housing, and the end of the motor unit comprises a portion of the gear extending from the housing. (5) The kit according to embodiment 4, wherein a part of the gear extending from the housing has a diameter smaller than the diameter of the motor housing.

[0236] (6) The kit according to any one of embodiments 3 to 5, wherein the motor end portion is a conical motor end portion and / or a tapered motor end portion shaped to be disposed within the socket. (7) The kit according to any one of embodiments 1 to 6, wherein the support has one or more radially extending portions that interface with the motor adapter. (8) The kit according to any one of embodiments 1 to 7, wherein the motor adapter comprises a housing having one or more openings, and the housing is attached to the support by one or more screws or pins. (9) The kit according to any one of embodiments 1 to 7, wherein the motor adapter comprises a housing having one or more openings shaped to receive the support, and an inner diameter of the opening is larger than an outer diameter of the support. (10) The kit according to embodiment 9, wherein the one or more openings form a channel sized and shaped to receive the support.

[0237] (11) The kit according to embodiment 9 or 10, wherein an inner portion of the one or more openings is circular. (12) The kit according to any one of embodiments 9 to 11, wherein the support comprises a window, and the motor adapter does not block the window when coupled to the support. (13) The kit according to any one of embodiments 9 to 12, wherein the support comprises a visual indicator indicating an extension length of the support, and the motor adapter housing comprises a window or one or more elongated openings that are at least partially aligned with the visual indicator when the motor adapter is coupled to the support. (14) The kit according to any one of embodiments 9 to 13, comprising at least one motor connector shaped and sized to fasten the motor unit to the housing of the motor adapter. (15) The kit according to embodiment 14, wherein the motor connector is fitted into an opening in the housing and comprises one or more protrusions configured to lock the motor connector to the housing.

[0238] (16) The kit according to embodiment 14 or 15, wherein the motor unit comprises a groove, and the motor connector is shaped and sized to fit into the groove when the motor unit is fastened to the motor adapter housing. (17) The kit according to any one of embodiments 1 to 16, wherein the support column comprises a gear of the linear actuator located near the extending portion of the support column. (18) The kit according to embodiment 17, wherein the linear actuator gear is located at a distance of up to 5 cm from the extending portion. (19) The kit according to embodiment 17 or 18, wherein the motor adapter comprises a gear, and the motor adapter gear is configured to interact with the linear actuator gear when the motor adapter is coupled to the support column, whereby rotation of the motor adapter gear moves the linear actuator axially. (20) The kit according to embodiment 19, wherein the motor end interacts with the motor adapter gear when the motor is selectively attached to the motor adapter.

[0239] (21) The kit according to embodiment 20, comprising a manual motor adapter interface shaped and sized to interact with the motor adapter gear such that manual rotation of the manual motor adapter interface moves the linear actuator axially. (22) The kit according to embodiment 21, wherein the motor adapter gear interacts alternately with the manual motor adapter interface and the motor end. (23) The kit according to embodiment 21 or 22, wherein an end of the manual motor adapter interface is shaped to be disposed within the motor adapter fastener. (24) A kit according to any of embodiments 19 to 23, being detachable from the motor adapter and comprising at least one gear lock configured to interlock and stop the movement of the motor adapter gear. (25) The kit according to embodiment 24, wherein the at least one gear lock is disposed within the motor fastener and has a first end formed and sized to interlock with the motor adapter gear, and a second end extending from the motor fastener and formed and sized to interlock with the housing of the motor adapter.

[0240] (26) A kit according to any of embodiments 1 to 25, comprising a bone fixation device including the strut and at least two spaced-apart frames, each frame configured to be coupled to a different end of the strut and a bone connector extending from a bone, at least one of the spaced-apart frames comprising an arc or ring that at least partially surrounds a patient's limb. (27) At least one electrical cable, and a control unit reversibly coupled to a frame of the at least two frames and connected to the motor and / or the motor adapter by the at least one electrical cable. (28) The kit according to embodiment 27, comprising a control unit frame interface fixedly connectable to the frame of the at least two frames, the control unit being configured to be detachable from the control unit frame interface. (29) The kit according to embodiment 27 or 28, wherein the control unit comprises at least one motor connector configured to receive the at least one cable. (30) A kit according to embodiment 29, comprising: a control circuit connected to the at least one motor connector; and a user interface configured to generate an instruction detectable by a human, wherein the control circuit sends a signal to the user interface to generate the instruction detectable by the human according to a signal received from the at least one motor connector.

[0241] (31) A kit according to embodiment 30, wherein the at least one motor unit comprises at least one electric motor and at least one positioning sensor configured to record the rotation of the at least one electric motor, and the control circuit measures the extension of a support column coupled to the at least one motor unit using the motor rotation record of the at least one positioning sensor. (32) A motor adapter coupled to a support column of a bone fixation device and selectively coupled to a motor unit, comprising: a housing coupled to the support column of the bone fixation device; a motor fastener in the housing shaped and sized to receive and restrain lateral movement of an end of the motor unit. (33) The adapter according to embodiment 32, wherein the housing comprises at least one opening shaped and sized to receive the support column. (34) The adapter according to embodiment 32 or 33, comprising one or more connectors and / or openings in the housing, wherein the one or more connectors and / or openings are configured to attach the motor adapter to the support column of the bone fixation device using one or more pins or screws transverse to the opening. (35) The adapter according to any one of embodiments 32 to 34, wherein the housing comprises a gear in the housing arranged to interact with a gear of a linear actuator of the support column when the housing is coupled to the support column.

[0242] (36) The adapter according to embodiment 35, wherein the motor adapter gear is located at the motor fastener and is configured to be interlocked with the motor end. (37) The adapter according to embodiment 35 or 36, further comprising a motor adapter manual interface that at least partially penetrates into the housing and is configured to be interlocked with the motor adapter gear. (38) The adapter according to embodiment 37, wherein the motor adapter gear is configured to be alternately interlocked with the motor end and the motor adapter manual interface. (39) A method for coupling a motor to a bone fixation device, comprising: coupling an end of the motor to a socket of a motor adapter connected to a strut of the bone fixation device; restraining lateral movement of the motor end by the socket; actuating the motor to extend an extending portion of the strut. (40) The method according to embodiment 39, wherein the coupling includes functionally coupling the motor end to a linear actuator gear of the strut.

[0243] (41) The method according to embodiment 39 or 40, wherein the coupling includes interlocking the motor end with a gear of the motor adapter. (42) The method according to any one of embodiments 39 to 41, further comprising connecting the motor to a control unit of the bone fixation device, and wherein the actuation includes actuating the motor by the control unit according to an instruction stored in a memory of the control unit. (43) The method according to any one of embodiments 39 to 42, further comprising, prior to the actuation, adjusting an angle between a horizontal axis of the motor adapter and at least one frame of the bone fixation device, and locking the motor adapter to the adjusted frame. (44) The method according to embodiment 43, wherein the adjustment includes rotating the motor adapter and the strut about a longitudinal axis of the strut. (45) The method according to embodiment 39, including attaching the motor adapter to a strut of the bone fixation device before the said connection.

[0244] (46) The method according to embodiment 45, wherein the said attachment includes functionally connecting a gear of the motor adapter to a linear actuator of the strut. (47) The method according to any one of embodiments 39 - 46, including identifying that the motor is connected to the correct strut of the bone fixation device by using a computer to read an identification code associated with the motor before the said operation. (48) A method for replacing a strut of a bone fixation device, comprising: removing a motor from a first strut connected to the bone fixation device; in the bone fixation device, replacing the first strut with a second strut; and attaching the removed motor to the second strut. (49) The method according to embodiment 48, wherein the said removal includes removing the motor from a first motor adapter coupled to the first strut, and the said attachment includes attaching the motor to a second motor adapter coupled to the second strut. (50) The method according to embodiment 48, wherein the said removal includes removing a motor adapter connected to the motor from the first strut, and the said attachment includes attaching the motor adapter to the second strut.

Claims

1. A kit comprising: A strut of a bone fixation device including a fixed portion and an extending portion, the strut comprising a linear actuator mechanically connected to the extending portion; At least one motor adapter coupled to the linear actuator, the motor adapter comprising a motor fastener; At least one motor unit selectively detachable from the motor fastener, the motor unit being functionally coupled to the linear actuator and configured to axially extend the extending portion of the strut; The motor fastener being shaped and sized to receive a portion of the motor unit; The motor fastener comprising a socket shaped to receive an end of the motor unit; The kit, wherein the end of the motor unit is a conical motor end and / or a tapered motor end shaped to be disposed within the socket.

2. The kit according to claim 1, wherein the motor unit comprises a housing, a motor, and a gear extending from the motor unit within the housing, and the end of the motor unit comprises a portion of the gear extending from the housing.

3. The kit according to claim 1 or 2, wherein the strut comprises one or more radially extending portions that interface with the motor adapter.

4. The kit according to any one of claims 1 to 3, wherein the motor adapter comprises a housing having one or more openings, and the housing is attached to the strut by one or more screws or pins.

5. The motor adapter comprises a housing having one or more openings shaped to receive the strut, and an inner diameter of the opening is larger than an outer diameter of the strut. The strut comprises a visual indicator indicating the extension length of the strut, and the housing of the motor adapter comprises a window or one or more elongated openings that are at least partially aligned with the visual indicator when the motor adapter is coupled to the strut. The kit according to any one of claims 1 to 4. **Claim 6** A kit comprising A strut of a bone fixation device including a fixed portion and an extending portion, the strut comprising a linear actuator mechanically connected to the extending portion; At least one motor adapter coupled to the linear actuator, the motor adapter comprising a motor fastener; At least one motor unit selectively detachable from the motor fastener, the motor unit being functionally coupled to the linear actuator and configured to axially extend the extending portion of the strut. The motor fastener is shaped and sized to receive a portion of the motor unit. The strut comprises a gear of the linear actuator located near the extending portion of the strut. The motor adapter comprises a motor adapter gear, the motor adapter gear being configured to interact with the gear of the linear actuator when the motor adapter is coupled to the strut, whereby rotation of the motor adapter gear moves the linear actuator axially. A kit comprising at least one gear lock detachable from the motor adapter and configured to interlock and stop the movement of the motor adapter gear. **Claim 7** The at least one gear lock is disposed within the motor fastener and comprises a first end shaped and sized to interact with the motor adapter gear, and a second end extending from the motor fastener and shaped and sized to interact with the housing of the motor adapter. The kit according to claim 6. **Claim 8** An osteofixation device comprising the strut and at least two spaced-apart frames, each frame configured to be coupled to a different end of the strut and a bone connector extending from a bone, at least one of the at least two spaced-apart frames comprising an arc or ring that at least partially surrounds a patient's limb, the osteofixation device. At least one electrical cable, A control unit reversibly coupled to a frame of the at least two spaced-apart frames, the control unit being connected to the motor unit and / or the motor adapter by the at least one electrical cable, a kit according to any one of claims 1 to 7.

9. Comprising a control unit frame interface fixedly connectable to the frame of the at least two spaced-apart frames, the control unit being configured to be removable from the control unit frame interface, the kit according to claim 8.

10. The control unit comprising at least one motor connector configured to receive the at least one electrical cable, the kit according to claim 8 or 9.

11. A control circuit connected to the at least one motor connector and a user interface configured to generate a human-detectable indication, the control circuit sending a signal to the user interface to generate the human-detectable indication according to a signal received from the at least one motor connector, the kit according to claim 10.

12. The at least one motor unit comprising at least one electric motor and at least one positioning sensor configured to record rotation of the at least one electric motor, the control circuit measuring elongation of the strut coupled to the at least one motor unit using the recording of the at least one positioning sensor, the kit according to claim 11.

Citation Information

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