Bone transport system and method

Abstract

Systems, methods, and devices for lateral bone transport. A transverse bone transport system may include a template for measuring and cutting a bone segment, and a distractor for moving the bone segment. The template may include a plate including an opening configured to fit a needle cannula. The channel may extend from an opening in the plate to one side of the plate. The distraction device may include a first beam, a second beam, and an actuator including a knob configured to rotate in a first direction to increase a distance between the first beam and the second beam, and to rotate in a second direction to decrease the distance between the first beam and the second beam.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 506,888, filed on June 8, 2023. Technical Field

[0003] This disclosure relates generally to bone transport systems, and more particularly to templates, distractors and needles for bone transport systems, as well as methods of using bone transport systems. Background Technology

[0004] Foot ulcers are a common problem in patients with poorly controlled diabetes or peripheral artery disease. Transverse bone transport is one method for treating such foot ulcers. During transverse bone transport, a segment of the leg bone (usually the tibia) located at the ulcer site is cut and moved laterally along or away from the bone axis. This method is also known as the Ilizarov technique. By applying continuous tension to the bone tissue, transverse bone transport can stimulate the growth of new blood vessels in the tissue between the transported portion and the base of the bone, thereby increasing blood circulation and promoting active angiogenesis in the bone and the entire limb. This can improve the healing of foot ulcers caused by diabetes and peripheral artery disease of the lower extremities.

[0005] However, transverse bone transport systems can be difficult or inconvenient for surgeons or patients to use. Furthermore, transverse bone transport surgery can cause pain or discomfort for patients. Therefore, there is a need for improved transverse bone transport systems. Summary of the Invention

[0006] This disclosure describes apparatus, systems, and methods for lateral bone transport. According to some embodiments of this disclosure, a template is provided for creating a transport bone segment and attaching the segment to a lateral bone transport device for lateral bone transport. The template may include a plate having a top surface, a bottom surface, a first side, a second side opposite to the first side, a first opening extending from the top surface to the bottom surface, and a channel extending between the top and bottom surfaces and between the first opening and the first side of the plate. The width of the channel may be smaller than the width of the first opening. The template may also include a needle sleeve configured to fit into the first opening. The outer width of the needle sleeve may be greater than the width of the channel.

[0007] In some embodiments, the template can include a wire sleeve configured to fit within the needle sleeve. In some embodiments, an outer width of the wire sleeve can be less than an inner width of the needle sleeve. In some embodiments, the template can include a drill bit sleeve configured to fit within the needle sleeve. In some embodiments, an outer width of the drill bit sleeve can be less than an inner width of the needle sleeve. In some embodiments, the first opening can be angled toward one end of the plate such that when the needle sleeve is placed in the first opening, the needle sleeve is angled relative to a top surface of the plate. In some embodiments, the plate can further include a first end extending between the first side and the second side, a second end opposite the first end and extending between the first side and the second side, and a plurality of corners between the first side, the first end, the second side, and the second end. In some embodiments, the template can further include a drill guide including a guide shaft, a guide opening aligned with the guide shaft, and an alignment structure configured to engage with a first corner of the plurality of corners. The alignment structure can include a first guide wall configured to engage with one of the first side or the second side, a second guide wall configured to engage with one of the first end or the second end, and a base surface configured to engage with the top surface. When the alignment structure is engaged with the first corner of the plate, the guide shaft can be angled relative to the top surface of the plate.

[0008] In some embodiments, the template further includes a second opening extending from the top surface to the bottom surface, a second channel extending between the top surface and the bottom surface and between the second opening and the first side of the plate, and a needle guide aperture extending from the top surface to the bottom surface and disposed on a longitudinal axis between the first opening and the second opening. In some embodiments, the plate further includes an extension extending upward around at least a portion of the first opening.

[0009] Some embodiments of the present disclosure include a distractor or distractor for a lateral bone transport system. The distractor can include a first beam that can include a first opening and a first movable half-needle holder. The distractor can further include a second beam that can include a second opening and a second movable half-needle holder. A length of the second beam can be greater than a length of the first beam. The first movable half-needle holder and the second movable half-needle holder can be longitudinally and radially offset. The distractor can further include an actuator that includes a knob and a threaded rod disposed within the first beam and the second beam. The knob can be configured to rotate in a first direction to increase a distance between the first beam and the second beam and in a second direction to decrease the distance between the first beam and the second beam.

[0010] In some embodiments, the actuator can be rotatable between a plurality of discrete rotational positions. In some embodiments, each of the plurality of discrete positions can be separated from an adjacent discrete position by a set distance. In some embodiments, the set distance can correspond to a discrete lateral distance between the first beam and the second beam.

[0011] In some embodiments, the first and second movable half needle retainers can be configured to pivot between a plurality of angular positions. In some embodiments, the first movable half needle retainer can be configured to retain a first needle, wherein the first movable half needle retainer can be configured to tighten around the first needle such that the first needle is retained in a first angular position of the plurality of angular positions. In some embodiments, the second movable half needle retainer can be configured to retain a second needle, wherein the second movable half needle retainer can be configured to tighten around the second needle such that the second needle is retained in a second angular position of the plurality of angular positions. In some embodiments, the first and second angular positions are different. In some embodiments, the threaded rod can be threadably coupled to the second beam such that the actuator can be configured to move the first beam relative to the second beam. In some embodiments, the retractor can further comprise a support post coupled to at least one of the first or second beams and disposed proximate to the threaded rod.

[0012] In some embodiments, the first and second movable half needle retainers can comprise a threaded shaft disposed in the first and second openings of the first and second beams and tightened by the first and second half needle retainer nuts such that the needle is retained in one of a plurality of angular positions. In some embodiments, the first and second beams can comprise slotted first and second openings for receiving the needle retainers. In some embodiments, the vertical slot can comprise an outer spherical surface adjacent to the slot, one side of which has a convex surface for engaging the movable half needle retainer and an opposite side having a mating concave surface for engaging the tightening nut. In some embodiments, the first and second half needle retainer tightening nuts can comprise a convex surface that mates with the concave surface of the spherical portion of the vertical slotted opening of the first and second beams. In some embodiments, the first and second beams can comprise horizontally or obliquely slotted openings to provide flexibility in the distance between the retraction mechanism and the skin for the movable half needle retainers.

[0013] Some embodiments of the present disclosure can include a kit for a lateral bone transport system. The kit can include a template, a distractor, and a plurality of needles. The template can further include a plate having a top surface, a bottom surface, a first side, a second side opposite the first side, an opening extending from the top surface to the bottom surface, and a channel extending between the top surface and the bottom surface and between the opening and the first side of the lower plate. The channel can have a width that is less than a width of the opening. The template can further include a needle sleeve configured to fit within the opening. The needle sleeve can have an outer width that is greater than the width of the channel. The distractor can include a first beam that can include a first opening and a first movable half-needle holder. The distractor can further include a second beam that can include a second opening and a second movable half-needle holder. The second beam can have a length that is greater than a length of the first beam. The first beam and the second beam can be longitudinally offset. The distractor can further include an actuator including a knob and a threaded rod disposed within the first beam and the second beam. The knob can be configured to rotate in a first direction to increase a distance between the first beam and the second beam and to rotate in a second direction to decrease the distance between the first beam and the second beam.

[0014] In some embodiments, the plate can further include a first end extending between the first side and the second side, a second end opposite the first end and extending between the first side and the second side, and a plurality of corners between the first side, the first end, the second side, and the second end. In some embodiments, the template can further include a drill guide including a guide shaft, a guide opening aligned with the guide shaft, and an alignment structure configured to engage a first corner of the plurality of corners. The alignment structure can include a first guide wall configured to engage one of the first side or the second side, a second guide wall configured to engage one of the first end or the second end, and a base surface configured to engage the top surface. When the alignment structure is engaged with the first corner of the plate, the guide shaft can be angled relative to the top surface of the plate. In some embodiments, at least one needle of the plurality of needles can have a width that is less than the width of the channel.

[0015] Some embodiments of the present disclosure can include a method of performing a bone transport. The method can include positioning a template over a transport segment of a bone, wherein the template includes a plate having a top surface, a bottom surface opposite the top surface, a first side, and a second side opposite the first side. The method can further include holding the template in a first position relative to the bone. The method can further include forming a plurality of holes in the bone proximate at least the first side and the second side using the template. The method can further include cutting the transport segment from the bone using the plurality of holes.

[0016] In some embodiments, forming the plurality of holes in the bone using the template can include engaging the template with a drill guide and guiding a drill bit through the drill guide to form the plurality of holes. In some embodiments, the template can include a needle guide aperture, and the method can further include inserting a first guide wire into the needle guide aperture.

[0017] In some embodiments, the method can further include inserting a half-needle into the transport segment through a needle cannula attached to the template after positioning the template over the transport segment. In some embodiments, the template can include a first opening to receive the needle cannula, and the needle cannula can include a second opening. In some embodiments, the template can include a suture cannula configured to be inserted into the second opening of the needle cannula, and a third opening. In some embodiments, the method can further include inserting a second guide wire into the transport segment of the bone through the third opening of the suture cannula before inserting the half-needle into the transport segment through the needle cannula. In some embodiments, the method can further include covering the flap over the template and the second guide wire after inserting the second guide wire through the third opening of the suture cannula, wherein the suture cannula extends through a hole in the flap. In some embodiments, the method can further include removing the second guide wire and the suture cannula after inserting the second guide wire into the transport segment of the bone through the third opening of the suture cannula. In some embodiments, the needle cannula is removed upward along a longitudinal axis of the half-needle after cutting the transport segment. In some embodiments, the method can further include laterally removing the plate along an axis substantially perpendicular to the longitudinal axis of the half-needle after removing the needle cannula.

[0018] Some embodiments of the present disclosure can include a distractor for a lateral bone transport system. The distractor can include a first beam including a first opening and a first movable half-needle holder, and a second beam including a second opening and a second movable half-needle holder. A length of the second beam can be greater than a length of the first beam. The first and second movable half-needle holders can be longitudinally and radially offset. The distractor can further include an electric actuator including a threaded rod disposed within the first opening of the first beam and the second opening of the second beam, and an electric motor in operable connection with the threaded rod. The electric motor can be configured to drive the threaded rod to rotate in a first direction to increase a distance between the first beam and the second beam, and to rotate in a second direction to decrease the distance between the first beam and the second beam.

[0019] In some embodiments, the actuator can include a first gear coupled with the motor such that the motor is configured to rotate the first gear, and a second gear meshed with the first gear such that the first gear is configured to rotate the second gear when the motor rotates the first gear. The second gear can be coupled with the threaded rod such that the second gear is configured to rotate the threaded rod when the first gear rotates the second gear. In some embodiments, the distractor can further include a power source and a processor circuit operably coupled with at least one of the motor or the power source, wherein the processor circuit is configured to control at least one of the motor or the power source. In some embodiments, the distractor can further include one or more sensors configured to acquire measurement data and transmit the data to the processor circuit. In some embodiments, the processor circuit can be configured to receive the acquired measurement data from the one or more sensors. In some embodiments, the processor circuit can include an artificial intelligence program that uses the acquired measurement data to generate a treatment regimen. In some embodiments, the processor circuit can be configured to control at least one of the power source or the motor according to the generated treatment regimen. In some embodiments, the processor circuit can be configured to transmit the acquired measurement data to a computer system. In some embodiments, the processor circuit can control at least one of the power source or the motor according to a sinusoidal rate of distraction and compression. In some embodiments, the lateral bone transport device can include a plurality of sensors for measuring blood volume, blood flow, vascularization / neovascularization, strain, or displacement.

[0020] In some embodiments, a distraction mechanism for lateral bone transport can be used in combination with a ring or semi-ring external fixation device. In some embodiments, the distraction mechanism can be directly attached to the ring or semi-ring external fixation device. In some embodiments, a movable half-pin holder can be used to attach to the ring or semi-ring external fixation device.

[0021] In some embodiments, the lateral bone transport device can include a module for delivering chemical / biological agents.

[0022] In some embodiments, the lateral bone transport device can include a module for mechanical stimulation of neovascularization and increasing blood volume and flow.

[0023] Additional aspects, features, and advantages of the disclosure will appear from the following detailed description, in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0024] For a more complete understanding of the present disclosure and its advantages, reference is now made to the following description taken in conjunction with the accompanying drawings in which like reference numerals represent like features in which:

[0025] FIG. 1A is an exploded view of a template for a bone transport system in accordance with some embodiments of the present disclosure.

[0026] FIG. 1B is FIG. 1A an assembled side view of the template shown.

[0027] FIG. 1C is FIG. 1A an assembled top perspective view of the template without the wire sleeve shown.

[0028] FIG. 1D is FIG. 1A a bottom perspective view of the plate of the template shown.

[0029] FIG. 1E is a perspective view of a drill sleeve of a template according to some embodiments of the disclosure.

[0030] FIG. 2A is a perspective front view of a distractor of a bone transport system according to some embodiments of the disclosure.

[0031] FIG. 2B is FIG. 2A a top view of the distractor shown.

[0032] FIG. 2C is FIG. 2A a perspective rear view of the distractor shown.

[0033] FIG. 2D is FIG. 2A an exploded view of the distractor shown.

[0034] FIG. 3A is a perspective front view of a T-shaped drill guide according to some embodiments of the disclosure.

[0035] FIG. 3B is FIG. 3A a perspective side view of the T-shaped drill guide shown.

[0036] FIG. 3C is FIG. 3A a perspective bottom view of the T-shaped drill guide shown.

[0037] FIG. 3D is a perspective side view of a T-shaped drill guide according to some embodiments of the disclosure FIG. 3A inserted therein and used to drill around a corner of a plate of a template shown.

[0038] FIG. 3E is a perspective bottom view of a T-shaped drill guide according to some embodiments of the disclosure FIG. 3A used to drill around a corner of a plate of a template shown.

[0039] FIG. 3F is a perspective bottom view of a T-shaped drill guide according to some embodiments of the disclosure FIG. 3APerspective side view of a T-shaped drill guide shown with a drill bit inserted therein and used to drill a hole around the side of a plate of a template.

[0040] FIG. 4 is a flowchart of a method of using a bone transport system according to some embodiments of the disclosure.

[0041] FIG. 5A to FIG. 5Q illustrates various steps in a method of FIG. 4 according to some embodiments of the disclosure.

[0042] FIG. 6A is a diagram illustrating a cross-sectional view of a bone with a half-pin inserted therein according to some embodiments of the disclosure.

[0043] FIG. 6B is a diagram illustrating a side view of a transport segment of a bone according to some embodiments of the disclosure.

[0044] FIG. 7A to FIG. 7B illustrates another embodiment of a template according to some embodiments of the disclosure.

[0045] FIG. 8A to FIG. 8B illustrates another embodiment of a distractor according to some embodiments of the disclosure.

[0046] FIG. 9A illustrates FIG. 2A to FIG. 2D a distractor shown connected to a half-pin and a ring according to some embodiments of the disclosure.

[0047] FIG. 9B illustrates FIG. 2A to FIG. 2D a distractor shown connected to a half-pin and two rings according to some embodiments of the disclosure.

[0048] FIG. 10A to FIG. 10L illustrates various embodiments of a template according to some embodiments of the disclosure.

[0049] While similar reference numbers can be used to refer to similar elements in the various exemplary embodiments, it is to be understood that each of the various exemplary embodiments can be viewed as a distinct variant from the others. DETAILED DESCRIPTION

[0050] Exemplary embodiments will now be described with reference to the drawings, which constitute a part of this specification, illustrate implementations that can be used to practice the exemplary embodiments, and are not intended to limit the scope of the exemplary embodiments and equivalents thereof. As used in this specification and the appended claims, the terms “example,” “exemplary,” and “illustrative” indicate that the subject matter described is an example or illustration of the subject matter that is not necessarily to be construed as preferred or advantageous over other examples or illustrations. Furthermore, the terms “comprise,” “comprising,” “include,” “including,” and the like as used herein are specifically intended to be construed as open-ended terms rather than terms of limitation. Likewise, the term “comprising” shall also cover the terms “consisting essentially of” and “consisting of.” Moreover, the terms “first,” “second,” and the like as used herein are not intended to denote a physical order, a sequence, or a ranking, but are used for purposes of nomenclature. As used herein, the term “plate” can refer to any substantially planar structure or any other three-dimensional structure and equivalents thereof, including those having one or more non-planar portions along one or more axes, unless otherwise specifically defined. Furthermore, as used herein, the terms “opening,” “recess,” “aperture,” and equivalents thereof can include any hole, space, area, depression, channel, slot, bore, and equivalents thereof, which can be substantially circular, elliptical, square, rectangular, hexagonal, and / or any other shape, and / or combinations thereof, and which can be defined by a portion of a surface of a material, substantially or completely. Furthermore, as used herein, the word “in” can include “in” and “on” and the words “a,” “an,” and “the” can include singular and plural references, unless otherwise specifically defined. Furthermore, as used herein, the word “by” can also mean “based on” depending on the context. Furthermore, as used herein, the word “if’ can also mean “when” or “in response to” depending on the context. Furthermore, as used herein, the word “and / or” can refer to and encompass any and all possible combinations of one or more of the associated listed items.

[0051] Additionally, the section headings herein are provided for consistency with the suggestions of 37 C.F.R. 1.77 and are in no way limiting on the subject matter disclosed herein. Specifically, the description of certain technology in the “Background” section is not an admission that such technology is prior art to any of the applications of the present disclosure. Moreover, the mere inclusion of certain technology in the “Summary” section is not meant to indicate that such technology is a prior art to any of the applications of the present disclosure. Additionally, the reference in the “Summary” section to “application” should not be construed as a limitation on the scope of the disclosure nor as an indication that a single, complete embodiment of the disclosed subject matter is necessarily described by the application. The subject matter of the present disclosure can be implemented in a variety of ways and embodiments and equivalents thereof are contemplated. The scope of the subject matter of this disclosure is thus indicated by the appended claims, rather than by the description that is provided herein. The present disclosure hereby incorporates by reference the entire contents of U.S. Provisional Application No. 63 / 507,067, filed on June 8, 2023.

[0052] The present disclosure relates, in part, to a bone transport system for use in orthopedic surgery. In one application, the bone transport system can be used to treat foot ulcers by performing transverse tibial transport to stimulate cell growth and neovascularization and increase blood flow, thereby improving healing of foot ulcers. The bone transport system can enable a physician to measure and cut a portion of a bone and move the portion of the bone transversely relative to surrounding bone (i.e., a base) to stimulate blood flow. The bone transport system can be used to form and attach to a portion of a bone and can move the portion of the bone generally transversely from an axis of the bone during treatment. The portion of the bone can be referred to as a bone transport segment or transport segment. The bone surrounding the transport segment can be referred to as a base of the bone. Moving the transport segment can stimulate cell growth and increase blood flow to the leg, thereby promoting healing of foot ulcers at the end of the limb.

[0053] The bone transport system includes a template 100 (see, e.g., FIG. 1), a distractor 200 (see, e.g., FIG. 2), one or more anchors (e.g., half-pins 400 (see, e.g., FIG. 4)), one or more guide wires 190 (see, e.g., FIG. 5), and a guide pin or guide wire 192 (see, e.g., FIG. 6). FIG. 1A to FIG. 1D FIG. 2A to FIG. 2D FIG. 5J to FIG. 5Q FIG. 5D FIG. 5G to FIG. 5J FIG. 5A to FIG. 5D

[0054] FIG. 1A to FIG. 1D An example of a template 100 according to some embodiments of the present disclosure is shown. FIG. 1A is an exploded perspective top view of the template. FIG. 1B is an assembled side view, FIG. 1C is an assembled perspective top view of the template 100 without the suture sleeve 108. FIG. 1D is a perspective bottom view of the plate 104 of the template 100. The template 100 includes the plate 104, the anchor or half-pin sleeve guide 106, and the suture sleeve guide 108. In some embodiments, the template 100 can also include a stopper or cover (not shown). The template 100 can be placed on the skin of a patient over a portion of a bone that a physician has selected as a transport segment 50 (see, e.g., FIG. 5). The template 100 can then be used to measure, delineate, define, or mark a flap over the transport segment 50. The flap can enable a physician to access the bone to form the transport segment 50. The template 100 can be placed directly on the selected transport segment 50 and can be used to measure, delineate, or define the transport segment 50 of the bone so that it can be moved to stimulate blood flow to the end of the limb. FIG. 5B FIG. 5P to FIG. 5Q FIG. 6A to FIG. 6B

[0055] ​​​​​​​​​The template 100 includes a plate 104. The function of the plate 104 is to guide a bone fixation device or anchor, such as a half-pin 400, a guide wire, an anchor, a screw, a cable, or any other suitable bone fixation device. In addition, with the aid of these fixation devices, the plate 104 anchors the template 100 to the bone and maintains its position on the bone during the drilling operation. The plate 104 can have a top surface 122, a bottom surface 124, two end portions 126, and two side portions 128 disposed between the top surface 122 and the bottom surface 124, between the two end portions 126. The plate 104 can include two openings 130 that extend through the plate 104. The openings 130 can be generally circular. In other embodiments, the openings 130 can be any suitable shape, such as oval, rectangular, square, ovoid, egg-shaped, ellipsoidal, or ovate. One or more extensions 132 can be provided around the openings 130 to provide additional support for the cannula 106, 108 or guide wire 190 or half-pin 400 (not shown, see, e.g. FIG. 5J to FIG. 5Q , one or more guide wires 190 (see, e.g. FIG. 5G to FIG. 5J )) disposed therein. The plate 104 can also include a channel 134 that extends from the opening 130 to one of the side portions 128 of the plate 104. In some cases, the width 138 of the channel 134 can be less than the width or diameter 136 of the opening 130.

[0056] The half-pin cannula 106 can have a size and shape suitable for installation within the opening 130 of the plate 104. The half-pin cannula 106 can be generally cylindrical, but can have any shape. In other embodiments, the half-pin cannula 106 can be any suitable shape, such as square, triangular, rectangular, polygonal, or irregular. The half-pin cannula 106 can be hollow from top to bottom, forming an opening 144, and can be formed to accommodate the half-pin 400 (see, e.g. FIG. 5J to FIG. 5Q ) to pass through the opening 144. The width or diameter 146 of the half-pin cannula 106 can be sized to fit the opening 130 of the plate 104 exactly (i.e., the diameter 146 of the half-pin cannula 106 can be slightly smaller than the diameter 136 of the opening 130 of the plate 104). The diameter 146 of the half-pin cannula 106 can be larger than the width 138 of the channel 134, such that the half-pin cannula 106 cannot be removed from the opening 130 through the channel 134.

[0057] In some embodiments, the opening 130 of the plate 104 may have threads 148, and the bottom of the half-needle sleeve 106 may have threads 149. Therefore, the threads 149 on the half-needle sleeve 106 may be configured to mate with the threads 149 on the opening 130 of the plate 104, allowing the half-needle sleeve 106 to be inserted therein. In the illustrated embodiment, the half-needle sleeve 106 includes external threads 149, and the opening 130 of the plate 104 includes internal threads 148. However, in other embodiments, this configuration may be reversed. Furthermore, in other embodiments, any suitable coupling mechanism may be employed to allow the half-needle sleeve 106 to be detached along the axis of the opening 130 of the plate 104. For example, the half-needle sleeve 106 may snap into the opening 130 of the plate 104, the half-needle sleeve 106 may form a frictional fit with the opening 130 of the plate 104, or the half-needle sleeve 106 may be screwed in using a quarter-turn technique to couple with the opening 130.

[0058] In some embodiments, the outer surface of the half-needle cannula 106 above the thread 149 may include a plurality of flat surfaces 145. The flat surfaces 145 may make it easier for a physician to grip and manipulate the half-needle cannula 106. However, any suitable grip structure may be used for the half-needle cannula 106. For example, the half-needle cannula 106 may include ridges, tabs, or handles, or may include softer or more resilient materials to improve the grip of the half-needle cannula 106.

[0059] The sleeve 108 may have a size and shape suitable for installation within the opening 144 of the half-needle sleeve 106. The sleeve 108 may be generally cylindrical. In other embodiments, the sleeve 108 may be any suitable shape, such as square, triangular, rectangular, polygonal, or irregular. Each sleeve 108 may be hollow from top to bottom, thus forming an opening 150. The opening 150 in the sleeve 108 may be formed to accommodate a guide wire 190 (see example...). FIG. 5G to FIG. 5J The guidewire passes through opening 150. Opening 150 can have any shape that substantially matches the cross-section of guidewire 190, such as circular, cylindrical, square, rectangular, polygonal, or irregular.

[0060] Each sleeve 108 includes a head 152 extending upward and outward from the axis 154 of the sleeve 108. In some embodiments, the top 156 of the head 152 is rounded or curved from the maximum diameter 158 to the opening 150. Thus, the head 152 forms a hemispherical shape. The head 152 of the sleeve 108 is generally smooth so that the sleeve 108 does not irritate the skin in contact with the head 152.

[0061] Plates 102 and 104 may include a guide pin aperture 194, the shape of which is adapted to mount a guide pin or guide wire 192 (see example). FIG. 5A to FIG. 5D). The guide pin 192 can be configured to attach the template 100 to the bone prior to insertion of the guide wire 190 (see, e.g. FIG. 5B to FIG. 5C ), the detailed description of which follows.

[0062] As shown in FIG. 4A, in some cases, the openings 130 and extensions 132 of the plate 104 can be angled outwardly toward the end 126 of the plate 104. FIG. 1B As shown in FIG. 4A, in some cases, the openings 130 and extensions 132 of the plate 104 can be angled outwardly toward the end 126 of the plate 104. FIG. 1B The openings 130 (and corresponding half-pin sleeves 106) on the left side of the plate 104 are oriented at an angle a1 relative to vertical. FIG. 1B The openings 130' (and corresponding half-pin sleeves 106') on the right side of the plate 104 are oriented at an angle a2 relative to vertical. This will ultimately result in the half-pins 400 (not shown) being guided to an angle a1 (for pin 400) and a2 (for pin 400') during insertion, such that the tips of the half-pins 400, 400' converge within the transfer segment 50.

[0063] The angles a1 and a2 can be any suitable value. For example, a1 and a2 can be any angle in the range of 0 degrees to 80 degrees. In some embodiments, a1 or a2 can be ±0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, or 80 degrees. In some embodiments, the openings 130, 130' can be angled at 15 degrees relative to vertical. In some cases, the openings 130, 130' can be angled differently relative to the surface of the bone. Although the openings 130, 130' are shown as being angled inwardly toward each other, the openings 130, 130' can also be angled outwardly away from each other, or can be angled in the same direction.

[0064] Thus, when the half-pin sleeves 106 and wire sleeves 108 are inserted into the openings 130, the sleeves 106, 108 are also angled outwardly toward the end 126 of the plate 104, such that the sleeves 106, 108 are angled relative to the top surface 122 of the lower plate 204. This allows the half-pins 400 (see, e.g. FIG. 5K to FIG. 6A ) to be inserted into the transfer segment 50 such that they are angled outwardly toward the end 126 of the plate 104 and angled inwardly toward each other, such that they converge within the transfer segment 50. By angling the half-pins 400 inwardly toward each other, greater stability can be provided and the motion of the transfer segment 50 (see, e.g. FIG. 5K to FIG. 6A ) can be improved, the detailed description of which follows.

[0065] In some embodiments, the template 100 (or the guide wire 190) can include a cap, a bead, or a stopper (not shown). When the guide wire 190 is inserted through the suture sleeves 107, 108, the stopper can be placed on the guide wire in a fixed manner, or placed on the guide wire 190 such that the bottom of the stopper is in contact with the top of the suture sleeves 107, 108. Thus, the stopper functions as a depth limiter to limit the depth of insertion of the guide wire into the bone. The guide wire 190 can then be cut above the stopper. Thus, the stopper can serve as a reference for cutting the guide wire 190. The stopper can be round such that when the flap is overlaid on the stopper, the guide wire 190 does not contact, cut, or damage the flap. In some embodiments, the stopper can have a pointed or conical upper portion, or can be round or a softened shape, such as a spherical, torus, ellipsoidal, conical, or oblate spherical shape. Thus, in some cases, the stopper can be configured to provide a smooth contact at the skin above the suture sleeves 107, 108.

[0066] In some embodiments, the plate 104 can include a tab 140 at the posterior side 128 for easier handling when the template 100 is placed on the skin and subsequently on the surface of the bone. The tab 140 can include grooves, rubber, or other features to improve the physician’s grip on the plate 104. As shown in FIG. 1, the tab 140 can be provided with a recess 143 at the bottom. The recess 143 can make it easier for the physician to grasp the tab 140, thus making it easier to manipulate the template 100 with the hand or a tool (e.g., a forceps) (not shown). FIG. 1A and FIG. 1D As shown, the tab 140 can be provided with a recess 143 at the bottom. The recess 143 can make it easier for the physician to grasp the tab 140, thus making it easier to manipulate the template 100 with the hand or a tool (e.g., a forceps) (not shown).

[0067] In some embodiments, the plate 104 can not have two openings 130. The plate 104 can have any suitable number of openings 130, including, for example, 1, 3, 4, or 5 openings 130. In some embodiments, the template 100 can have an extended guide aperture that forms a cut guide slot or a plurality of holes to guide the cutting of the bone. For example, the cut guide slot can guide a blade-edged cutting tool, and the plurality of holes can guide a drill bit. The plate 104 can be made of any suitable material, including metal or plastic, or a combination thereof.

[0068] In some embodiments, the template 100 can also include a drill guide or sleeve 160. According to one or more embodiments of the present disclosure, FIG. 1EA drill sleeve 160 is shown. Similar to the wire guide 108, the drill sleeve 160 is sized and shaped to fit within the opening 144 of the half-needle sleeve 106. The drill sleeve 160 may be generally cylindrical. In other embodiments, the drill sleeve 160 may be any suitable shape, including, for example, square, triangular, rectangular, polygonal, or irregular shapes. The drill sleeve 160 may be hollow from top to bottom, thus forming an opening 170. The opening 170 in the drill sleeve 160 may be formed to allow a drill bit to pass through, as described in more detail below.

[0069] The drill sleeve 160 may include a head 162 that extends upward and outward from the shaft 164. In some embodiments, the top 166 of the head 162 is generally flat, and its outer surface 168 extends downward from the top. Thus, the head 162 of the drill sleeve 160 may be formed into a cylindrical shape.

[0070] FIG. 2A to FIG. 2D An example of a tensioner 200 according to some embodiments of the present disclosure is shown. FIG. 2A It is a 3D front view. FIG. 2B It is a top view. FIG. 2C It is a 3D rear view. FIG. 2D This is an exploded view of the tensioner 200.

[0071] When half needle 400 (see example) FIG. 5J to FIG. 5Q The transfer segment 50 has been inserted (see example). FIG. 5B and FIG. 5P to FIG. 5Q After drilling around at least a portion of the transfer section 50, the tensioner 200 can be attached to the half-needle 400, and the additional half-needle 400' (see example) can be attached to it. FIG. 5O to FIG. 5Q It is inserted into the base 52 of the bone near the transport segment 50 and can be attached to the retraction device 200, as described in more detail below. The retraction device 200 can move the transport segment 50 laterally or transversely relative to the axis of the bone to stimulate blood flow to the extremity.

[0072] The tensioner 200 may include an upper beam 202, a lower beam 204, and an actuator 206. The upper beam 202 and the lower beam 204 may each have a half-needle retainer 208 at their respective ends 210 and 212. The length 203 of the upper beam 202 may be shorter than the length 205 of the lower beam 204. Therefore, the half-needle retainer 208 of the upper beam 202 is longitudinally offset relative to the half-needle retainer 208 of the lower beam 204. Thus, the half-needle retainer 208 of the upper beam 202 is located near the center of the tensioner 200, while the half-needle retainer 208 of the lower beam 204 is located away from the center of the tensioner 200.

[0073] The upper and lower beams 202, 204 can have openings 236 near the ends 210, 212. Each opening 236 can have a circular or partially spherical inner surface (not shown) and a circular or partially spherical outer surface 240. In some embodiments, the outer surface 240 can match the profile of the inner surface, while in other embodiments, the outer surface 240 can be cylindrical and the inner surface can be spherical to mate with the spherical nut 220.

[0074] The openings 236 can extend in the vertical direction or be slot-like. Three of the openings 236 can be oriented generally vertically (although they can be angled slightly relative to the vertical direction). Each of the three openings can have the same angle of inclination. However, a fourth opening 236’ on the upper beam 202 can be angled relative to the vertical direction and the other openings 236. For example, the fourth opening 236’ can be angled outward from the center by an angle in the range of 0 degrees to 90 degrees. This can provide the distractor 200 with greater flexibility in attaching the half-pins 400 to the half-pin holders 208.

[0075] The three half-pin holders 208 can be disposed in the three openings 236. The half-pin holder 208 can include a clamp with an outer portion 214 that is movably coupled to an inner portion 216. The half-pin holder 208 can include a threaded extension 218 that extends through the openings 236 in the beams 202, 204. A nut 220 can be threadably coupled to the threaded extension 218. The nut 220 can include a head 242 and a base 244. The head 242 can be hexagonal. In other embodiments, the head 242 can be other shapes, including, for example, square, pentagonal, circular, or any other shape. The base 244 can be circular, for example, partially or semi-spherical. The circular base 244 can be formed so that the nut 220 can pivot, rotate, or otherwise move along the inner surface 238 of the opening 236. The inner portion 216 of the clamp can have a flat or circular lower surface that can be formed so that it pivots, slides, rotates, or otherwise moves along the outer surface 240 of the opening 236. In some embodiments, the lower surface of the inner portion 216 can have a groove or other roughened structure to increase the friction between the inner portion 216 and the outer surface 240 of the opening 236.

[0076] In some embodiments, the three half-pin retainers 208 include a nut 220 having a circular base 244. However, the fourth half-pin retainer 208' can include a nut 220' having a similar hexagonal head 242' and a relatively cylindrical base 244'. The cylindrical base 244' can be smaller than the circular base 244 of the other three half-pin retainers 208. The fourth half-pin retainer 208' can include the same clamp (having the same outer portion 214 and inner portion 216) and the same threaded extension 218. The fourth half-pin retainer 208' can be configured to be inserted into the fourth opening 236' such that the fourth half-pin retainer 208' has a greater range of motion than the other three half-pin retainers 208.

[0077] In some embodiments, the fourth opening 236' can allow the fourth half-pin retainer 208' to move laterally or at an angle relative to the beam 202 while allowing the half-pin retainer 208' to pivot or rotate. Thus, the half-pin 400 disposed within the fourth half-pin retainer 208' can have an additional axis of motion. Advantageously, with the diverging half-pin axes, the fourth opening 236' in combination with the fourth half-pin retainer 208' can allow a physician to adjust the distance between the distractor 200 and the bone while maintaining the same pin angle. For example, if a patient has thicker skin or a large amount of fat, muscle, or other soft tissue between the skin and the bone, the fourth half-pin retainer 208' can be slid outward along the fourth opening 236' so that the distractor 200 can be moved away from the bone. The distance between the distractor 200 and the bone can be adjusted so that the distractor 200 contacts the skin or leaves a gap between the distractor 200 and the skin. Thus, the distractor 200 can be used for a variety of patients with varying amounts of soft tissue around the tibia.

[0078] For all half-pin retainers 208, 208', when the nut 220 is loosened, the outer portion 214 of the clamp can be configured to move outward from the beams 202, 204 and can cause the half-pin retainer 208, 208' to pivot, rotate, or otherwise turn. The half-pin retainer 208, 208' can also slide or move up or down along the opening 236, 236'. The outer portion 214 can have one or more slots or channels for accommodating the half-pin 400. Thus, the half-pin retainer 208, 208' can be moved to accommodate any angular position of the half-pin 400, including along an axis parallel to the beams 202, 204 (i.e., a horizontal axis) or perpendicular to the beams 202, 204 (i.e., a vertical axis).

[0079] When nuts 220, 220' move to tighten the clamp, outer portion 214 contacts and is pulled tight against inner portion 216 to hold or secure half-needle 400 to beams 202, 204. When tightened, the clamp can fix the angular position of half-needle 400, thereby preventing movement or rotation of outer portion 214 or half-needle 400 relative to beams 202, 204. In some embodiments, half-needle retainers 208, 208' can rotate through multiple discrete angular positions, or can rotate continuously through all angular positions. The inner surface of outer portion 214 and the outer surface of inner portion 216 may have interlocking grooves, allowing half-needle retainers 208, 208' to adapt to discrete angular positions and / or prevent movement of portions 214, 216 when the clamp is tightened. As described above, the fourth half-needle retainer 208' can have a larger range of motion than the other three half-needle retainers 208, and therefore can rotate over a larger angular range than the other three half-needle retainers 208.

[0080] While specific embodiments of the half-needle retainers 208, 208' are described herein, any suitable movable retainer 208, 208' configured to accommodate multiple angular positions of the half-needle 400 may be used. For example, one or more half-needle retainers 208, 208' may be ball-and-socket connections, hinged clamps, or may use screws or bolts, as described in more detail below.

[0081] The half-needle retainers 208, 208' of the upper beam 202 can be arranged to connect to the half-needle 400 in the transfer segment 50 of the bone inserted using the template 100, as described in more detail below. The half-needle retainer 208 of the lower beam 204 can be configured to attach to the half-needle 400' in the base 52 near the transfer segment 50 of the bone inserted.

[0082] Actuator 206 may include a knob 222 and a threaded rod 224. Beams 202 and 204 may each include a block 226 with an opening 227 to accommodate the threaded rod 224. Each block 226 may be coupled to the center of beams 202 and 204. Knob 222 may be coupled to one end of the threaded rod 224. Knob 222 may be positioned on top of the block 226 coupled to the upper beam 202, such that the threaded rod 224 extends through the openings 227 in both blocks 226. Support post 228 may be present, extending from an opening 229 in one block 226 to an opening 229 in the other block 226. Support post 228 may be positioned on either side of the threaded rod 224 and may be located close to the threaded rod 224 to provide support and prevent rotation of the upper beam 202 relative to the lower beam 204.

[0083] In some embodiments, threaded rods 224 can be fixedly connected to at least one of openings 227 in blocks 226. Threaded rods 224 can be threadably coupled to knobs 222. Knobs 222 can be rotated to move threaded rods 224 up and down within openings in knobs 222. Knobs 222 can be rotated in a first direction to move threaded rods 224 downward and can be rotated in a second, opposite direction to move threaded rods 224 upward. Thus, when knobs 222 are rotated in the first direction, upper and lower beams 202, 204 can be moved closer to each other. When knobs 222 are rotated in the second direction, upper and lower beams 202, 204 can be moved farther apart from each other. Support posts 228 can be movably coupled to at least one of blocks 226 (e.g., lower beam 204) to allow beams 202, 204 to move relative to each other.

[0084] In other embodiments, openings 227 in blocks 226 on lower beam 204 and / or blocks 226 on upper beam 202 can be threaded to threadably engage threaded rods 224. Knobs 222 can be rotated to move threaded rods 224 through openings 227 in blocks 226. Knobs 222 can be rotated in a first direction to move threaded rods 224 downward and can be rotated in a second, opposite direction to move threaded rods 224 upward. Thus, when knobs 222 are rotated in the first direction, upper and lower beams 202, 204 can be moved closer to each other. When knobs 222 are rotated in the second direction, upper and lower beams 202, 204 can be moved farther apart from each other. Support posts 228 can be movably coupled to one of blocks 226 to allow beams 202, 204 to move relative to each other. In other embodiments, no blocks 226 are coupled to upper beam 202 or lower beam 204.

[0085] Knobs 222 can be rotated through a plurality of discrete rotational positions. For example, knobs 222 can be configured to move in quarter turns by providing protrusions (not shown) on the bottom side of knobs 222 that mate with grooves (not shown) on blocks 226 at 90 degree intervals. Knobs 222 can include a hub adapter 235 having an opening 237 extending from the top to the bottom of hub adapter 235. Opening 237 can be configured to fit threaded rods 224. A spring 234 can be disposed between knobs 222 and hub adapter 235 to bias the protrusions toward the grooves. In this way, each time knobs 222 are turned, threaded rods 224 are moved a predetermined amount. For example, each quarter turn of knobs 222 can move threaded rods 224 up and down 0.25 millimeters (mm). In other examples, each full or partial rotation of the knobs can move the threaded rods 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 millimeter. The amount of movement of threaded rods 224 can correspond to the amount of movement of segments 50.

[0086] In other embodiments, the knob 222 can be continuously moved through any rotational position. In some cases, the distractor 200 can move the transport segment 50 in increments or discrete amounts from 0 mm distraction to 20 mm distraction back to 0 mm distraction.

[0087] According to one or more embodiments of the present disclosure, FIG. 3A to FIG. 3F An embodiment of a T-drill guide 500 is shown. FIG. 3A is a perspective front view, FIG. 3B is a perspective side view, FIG. 3C is a perspective bottom view of the T-drill guide 500. FIG. 3D is a perspective side view after insertion of a drill bit 384, FIG. 3E is a perspective bottom view of the T-drill guide 500 for drilling around a corner of a plate 104 of a template 100. FIG. 3F is a perspective side view of the T-drill guide 500 for drilling around a side 128 of a plate 104 of a template 100 after insertion of a drill bit 384. After the template 100 is placed on a bone, the T-drill guide 500 can be used to drill around the transport segment 50 of the bone (as shown in FIG. 5E to FIG. 5F ) and remove the half-pin sleeve 106 on the plate 104 around the half-pin 400 (as shown in FIG. 5L ).

[0088] The T-drill guide 500 includes a half-pin drill guide shaft 502 and a drill bit guide shaft 504. In some embodiments, the half-pin drill guide shaft 502 can form a base of the T-shape and the drill bit guide shaft 504 can form a top or crossbar of the T-shape. The half-pin drill guide shaft 502 includes an opening 506 extending from a bottom end 508 to a top end 510. A bottom portion 507 of the opening 506 can be, for example, hexagonal (but can be any shape) similar to a socket tool used to tighten a bolt. The bottom portion 507 of the opening 506 of the half-pin drill guide shaft 502 can be configured to fit over the hexagonal portion 145 of the half-pin sleeve 106. Thus, the half-pin drill guide shaft 502 can be configured to unscrew / unsheathe the threads 149 of the half-pin sleeve 106 from the threads 148 in the opening 130 of the plate 104. The half-pin drill guide shaft 502 can remove the half-pin sleeve 106 along the longitudinal axis of the half-pin 400 (see, e.g., FIG. 5L ) that was previously inserted into and into the bone through the opening 144 of the half-pin sleeve 106 (see, e.g., FIG. 5J to FIG. 5K ).

[0089] In other embodiments, the opening 506 can be entirely hexagonal. In yet other embodiments, the entire opening 506 can be cylindrical.

[0090] The drill bit guide shaft 504 can be coupled to the tip 510 of the half-needle drill guide shaft 502, allowing access to the opening 506 through the tip 510. The drill bit guide shaft 504 can have two ends: a first angle drill end 512 and a second side drill end 514. The peripheral drill guide shaft 504 can have an opening 520 extending from the angle drill end 512 to the side drill end 514.

[0091] The angle drill tip 512 can be configured to contact the corner 123 of the plate 104. For example, the angle drill tip 512 may include an alignment structure comprising a protrusion 516 extending upward from the base surface 517. The protrusion 516 may be cross-shaped or plus-shaped such that the corner 123 of the plate 104 fits into the corner 518 of the protrusion 516. Thus, the protrusion 516 may have: a first wall configured to contact the side 128 of the plate 104; and a second wall configured to contact the end 126 of the plate 104 on the other side of the corner 123. The base surface 517 of the angle drill tip 512 may contact, support, and / or press against the top surface 122 of the plate 104. An opening 520 of the drill guide shaft 504 may extend through the center of the protrusion 516.

[0092] The side-drilling end 514 may be configured to contact the side 128 or end 126 of the plate 104. For example, the side-drilling end 514 may include an alignment structure comprising a protrusion 522 extending upward from the base surface 526. The protrusion 522 may be linear in shape (e.g., may include a wall) such that the side 128 or end 126 of the plate 104 contacts the side 524 of the protrusion 522. The base surface 526 of the side-drilling end 514 may contact, support, and / or press against the top surface 122 of the plate 104. An opening 520 of the drill guide shaft 504 may extend through the center of the protrusion 522.

[0093] For the two ends 512, 514 of the drill guide shaft 504, the base surfaces 517, 526 are angled relative to the longitudinal axis of the drill guide shaft 504. In some embodiments, the base surfaces 517, 526 are neither perpendicular to nor parallel to the longitudinal axis, such that each base surface 517, 526 is at an angle between 0 and 90 degrees relative to the longitudinal axis. The base surfaces 517, 526 may be angled such that when one of the ends 512, 514 is located around the plate 104, the opening 520 of the drill guide shaft 504 is angled toward the plate 104.

[0094] like FIG. 3D As shown, when the corner drill end 512 of the peripheral drill guide shaft 504 is located at the corner 123 of the plate 104, the longitudinal axis of the peripheral drill guide shaft 504 is at an angle relative to the top surface 122 of the plate 104. Similarly, as FIG. 3F As shown, when the side drill end 514 of the peripheral drill guide shaft 504 is located on the side 128 or end 126 of the plate 104, the longitudinal axis of the peripheral drill guide shaft 504 is also at an angle relative to the top surface 122 of the plate 104.

[0095] Thus, the drill guide shaft 504 guides the drill 384 so that the hole drilled into the bone angles inward toward the plate 104. As a result, the mobilized segment 50 of the bone angles inward from the top to the bottom to prevent the mobilized segment 50 from falling into the base 52 of the bone, as will be described below in connection with FIG. 6. FIG. 6B as shown in greater detail below.

[0096] In other embodiments, the protrusions 516, 522 on the ends 512, 514 of the perimeter drill guide shaft 504 can be of any suitable shape. In some embodiments, one end of the perimeter drill guide shaft 504 can have a T-shaped protrusion that can be positioned around the corner 123 and the side 128 and end 126 of the plate 104.

[0097] According to some embodiments of the present disclosure, FIG. 4 is a flowchart illustrating an example of a method 300 of performing a bone mobilization using a bone mobilization system. The method 300 will be described in connection with FIG. 5A to FIG. 5Q The method 300 will be described. Steps 302-330 of the method 300 will be explained in connection with FIG. 5A to FIG. 5Q which illustrates various components of the system applied to a patient's anatomy.

[0098] According to the method 300, any suitable template can be used. For example, FIG. 1A to FIG. 1E the embodiment of the template 100 shown in FIG. 5A to FIG. 5Q is shown in FIG. 1. However, FIG. 7A to FIG. 7B or FIG. 10A to FIG. 10L any template shown in FIGS. 2-4 (described in greater detail below) can also be used by a method similar to the method 300.

[0099] FIG. 4 Step 302 of the method 300 shown can include placing the plate 104 of the template 100 over the skin over the desired mobilized segment 50 of the bone. The physician can select the desired mobilized segment 50 based on the anatomy of the bone, the condition of the surrounding soft tissue, the level of blood supply preserved by the limb, the ease of operation of the bone mobilization system, or any other suitable factor. For example, the plate 104 can be placed over the protrusion of the medullary cavity of the medial face of the tibia. The level and orientation of the plate can be confirmed by digital C-arm fluoroscopy or by a fixed digital x-ray.

[0100] FIG. 4 Step 303 of the method 300 shown can include inserting a first guide wire 192 through the skin and bi-cortically into the bone through the guide pin aperture 194 on the plate 104 of the template 100. The first guide wire 192 can extend through the skin, the subcutaneous soft tissue, and both cortical layers of the bone to stabilize the position of the template 100 and to make the first guide wire 192 as perpendicular to the bone as possible. The first guide wire 192 can be inserted into the desired mobilized segment 50 of the bone.

[0101] FIG. 4 Step 304 of the method 300 shown can include cutting the skin and accessing the area of the transport segment 50. After inserting the first guide wire 192, the physician can mark the skin around the plate 104 of the template 100. The physician can use the plate 104 as a guide to mark the skin with a marker pen or any other suitable implement. The skin can be marked around part or all of the perimeter of the upper plate 102. For example, the physician can mark only three sides around the template 100 to demarcate the flap. In some embodiments, the physician can mark only one or two sides, or all four sides around the plate 102. In particular, the back edge 380 of the perimeter of the plate 104 can be marked. The skin can also be marked through the opening 130 of the plate 104. These markings can demarcate the exit holes 382 within the flap. The skin can then be cut along the markings to form the flap (at least along the back side 380), the exit holes 382, and the guide wire opening around the first guide wire 192. The first guide wire 192 can be cut along the top surface 110 of the plate 104 so that the end of the first guide wire 192 is flush with the top surface 122. When the flap and opening are cut, the plate 104 of the template 100 can be removed. The plate 104 can be lifted up and away from the skin along the first guide wire 192. FIG. 5A The bone and skin (shown in phantom as transparent) are shown with the template 100 removed (and thus not shown) and the first guide wire 192 inserted therein. Cutting along the markings made using the template 100 demarcates a flap that includes the back side 380 and demarcates the exit holes 382, as shown in phantom. FIG. 5A

[0102] After the cutting is complete, the flap can be stretched to expose the bone of the transport segment 50. The physician can cut the skin and subcutaneous tissue from the skin to the bone. In some embodiments, the physician can make incisions along part or all of the perimeter markings to form the flap. In particular, the physician can make an incision along the back edge 380 of the perimeter of the tibial crest. The incision can be about 10 centimeters (cm). The two sides of the perimeter near the back side can also be cut. In some embodiments, these incisions can be about 5 millimeters (mm).

[0103] In addition, the physician can also cut the exit holes 382 to extend through the flap. The exit holes 382 can be sized and shaped to fit over the half needle cannula 106 and the suture cannula 108, as described in more detail below in connection with step 311 (see, e.g., FIG. 31). The flap can then be stretched or removed from the bone to expose the transport segment 50. In some embodiments, the physician can puncture the skin at the marked exit holes 382. The physician can pull the skin up along the first guide wire 192 to open the skin incision and expose the transport segment 50. FIG. 5C

[0104] FIG. 4 ​​Step 305 of the illustrated method 300 can include repositioning the template 100 onto the first guide wire 192 through the guide pin aperture 194 with the skin stretched. Step 306 can illustrate that the second and third guide wires 190 are inserted into the bone through the openings 150 of the suture sleeve 108 of the template 100. Step 306 is illustrated in FIG. 5B and FIG. 5C . FIG. 5B is a top perspective view, FIG. 5C is a side perspective view, illustrating the template 100 positioned over the first guide wire 192, which is positioned over the mobilization segment 50. The first guide wire 192 can be inserted into the guide pin aperture 194 of the plate 104 to center the plate 104 over the mobilization segment 50. The physician can adjust the plate 104 to properly align it over the mobilization segment 50. The physician can position the plate 104 so that the channel 134 of the plate 104 is oriented toward the leading side of the periphery (e.g., toward the flap being stretched). The half-pin sleeve 106 can be positioned in the opening 130 of the plate 104, and the suture sleeve 108 can be positioned in the half-pin sleeve 106. The suture sleeve 108 can be inserted into the half-pin sleeve 106 before or after the half-pin sleeve 106 is inserted into the opening 130 of the plate 104. In some embodiments, the sleeves 106, 108 can be assembled after the plate 104 is placed over the mobilization segment 50.

[0105] FIG. 4 Step 306 of the illustrated method 300 can include inserting the second and third guide wires 190 bicortically into the bone through the openings 150 of the suture sleeve 108 of the template 100. Step 306 is illustrated in FIG. 5D (not shown are the skin and subcutaneous tissue). The second and third guide wires 190 can be inserted by any suitable means, including drilling or tapping the end of the guide wire 190. In some embodiments, the guide wires 190 can be inserted so that they extend through the entire width of the bone, extending through both cortical layers of the bone and through the medullary canal therebetween. As illustrated in FIG. 5D , the guide wires 190 can be cut or trimmed along the top 156 of the head 152 of the suture sleeve 108. The guide wires 190 can be cut so that the ends of the guide wires 190 are flush with the top 156 of the head 152 of the suture sleeve 108, so as not to protrude above the head 152. Thus, the guide wires 190 can be relatively flat along the top 156 of the suture sleeve 108. Cutting the guide wires 190 can make the system easier to handle, and can prevent the guide wires 190 from scratching, cutting, irritating, or otherwise damaging the skin or soft tissue.

[0106] As described in greater detail above, the opening 130 of the plate 104 (and thus the half-pin sleeve 106 and the suture sleeve 108) is angled relative to the top surface 122 of the plate 104. Thus, the guide wires 190 are inserted so that they are angled inwardly within the mobilization segment 50.

[0107] Step 308 of method 300 can include drilling holes in the protrusions of the mobilization segment 50 using the T-drill guide 500 around the template 100. First, the physician can drill around each corner 123 of the plate 104 using the corner drill tip 512 of the perimeter drill guide shaft 504 of the T-drill guide 500, as shown (without the skin and subcutaneous tissue shown) in FIG. 6. The corner drill tip 512 can be positioned so that the corner 518 of the cross-shaped protrusion 516 contacts the corner 123 of the plate 104, and the base face 517 contacts the top face 122 of the plate 104. A drill bit 384 can then be inserted through the opening 520 of the perimeter drill guide shaft 504 and drilled into the bone to drill a hole therein. The perimeter drill guide shaft 504 can angle the drill bit 384 so that the hole drilled into the bone is angled inwardly toward the mobilization segment 50, as described above. FIG. 5E

[0108] Next, the physician can drill around the sides 128 and ends 126 of the plate 104 using the side drill tip 514 of the perimeter drill guide shaft 504 of the T-drill guide 500, as shown (without the skin and subcutaneous tissue shown) in FIG. 7. The side drill tip 514 can be positioned so that the side 524 of the linear protrusion 522 contacts the side 128 (or end 126) of the plate 104, and the base face 526 contacts the top face 122 of the plate 104. A drill bit 384 can then be inserted through the opening 520 of the perimeter drill guide shaft 504 and drilled into the bone to drill a hole therein. Again, the perimeter drill guide shaft 504 can angle the drill bit 384 so that the hole drilled into the bone is angled inwardly toward the mobilization segment 50, as described above. FIG. 5F

[0109] During this process, the physician can use the half-pin drill guide shaft 502 of the T-drill guide 500 as a handle to hold and manipulate the perimeter drill guide shaft 504.

[0110] Holes can be drilled along the entire perimeter of the plate 104. In some embodiments, 4 to 20 holes can be drilled around the perimeter of the mobilization segment 50. For example, holes can be drilled at the four corners 123 of the plate 104, and along the sides 128 and ends 126 between the corners 123.

[0111] Step 310 of method 300 can include cutting at least a portion of the bone between the plurality of holes drilled around the perimeter of the mobilization segment 50, as shown in FIG. 8. FIG. 5G FIG. 5G ​​​Step 311) described below is also shown. The bone can be cut between the holes to cut around at least a portion of the perimeter of the mobilization segment 50. The bone can be cut by any appropriate method, including manually cutting the bone between the drill holes using a bone chisel, or using a powered device such as a drill or a bone saw. In some cases, only the upper layer of cortical bone can be cut. In other embodiments, some or all of the bone marrow in the medullary cavity can be cut. In preferred embodiments, it is not necessary to cut all sides of the mobilization segment 50. In some embodiments, 3, 2, or 1 side can be cut. For example, in the embodiment shown, the posterior side of the mobilization segment 50 can not be cut. FIG. 5G In the embodiment shown, the posterior side of the mobilization segment 50 can not be cut.

[0112] FIG. 4 Step 311 of the method 300 shown can include repositioning the skin 60 over the template 100 and suture sleeve 108. FIG. 5G Repositioning the flap 62 over the template 100 and suture sleeve 108 according to step 311 can also be shown. After cutting between the holes along the perimeter of the mobilization segment 50, the flap can be placed back over the mobilization segment 50. The flap 62 can be pulled back over the plate 104. The half-needle sleeve 106, in which the suture sleeve 108 and the severed guide wire 190 are disposed, can be inserted through the corresponding exit hole 382 in the flap 62 so that it protrudes through and extends beyond the top of the flap 62. Thus, the bottom of the flap 62, possibly with subcutaneous soft tissue, can directly cover and contact the plate 104, the half-needle guide 106, and / or the suture guide 108. The tab 140 of the plate 104 can protrude from the posterior side 380 of the perimeter of the flap 62. As shown, the exit hole 382 is defined by two sidewalls of the skin that extend from the top to the bottom of the flap 62. Also, an opening can be provided at the posterior cut 380 between the posterior side of the flap 62 and the skin base 61 adjacent to the posterior side of the flap 62. The opening can extend from the top to the bottom of the skin. The plate 104 of the template 100 can be removed from the patient through the opening at the posterior cut 380, as will be described in more detail below in connection with step 324. FIG. 5G

[0113] FIG. 4 Step 312 of the method 300 shown can include removing the second guide wire 190 and the corresponding suture sleeve 108. Step 312 is shown in FIG. 5H (not shown with skin and subcutaneous tissue). The guide wire 190 and suture sleeve 108 can be removed generally transverse to the axis of the bone or at an angle. FIG. 5H The template 100 is shown after the second guide wire 190 and the corresponding suture sleeve 108 have been removed from the half-needle sleeve 106 (not shown with skin and subcutaneous tissue).

[0114] FIG. 4 ​Step 314 of the illustrated method 300 can include inserting the drill cannula 160 into the half-needle cannula 106 and drilling a hole in the mobilization segment 50. Step 314 is illustrated in FIG. 5I The shaft 164 of the drill cannula 160 can be inserted into the opening 144 of the half-needle cannula 106 such that the head 152 of the drill cannula 160 is in contact with the top of the half-needle cannula 106. The drill 384 can then be inserted through the drill cannula 160 and drilled into the mobilization segment 50 of the bone to drill a hole therein.

[0115] FIG. 4 Step 316 of the illustrated method 300 can include inserting the half-needle 400 through the half-needle cannula 106 into the mobilization segment 50. Step 316 is illustrated in FIG. 5J The half-needle 400 can be inserted by any appropriate method, including screwing in or tapping in. The half-needle 400 can be inserted through the half-needle cannula 106 such that the half-needle 400 is inserted into the mobilization segment 50 at an angle relative to the top surface 122 of the plate 104 (and thus also relative to the surface of the mobilization segment 50).

[0116] FIG. 4 Step 317 of the illustrated method 300 can include repeating steps 312-316 for a third guidewire 190, a corresponding wire cannula 108, and a half-needle 400. FIG. 5K A system after step 317 has been performed (i.e., after the guidewire 190 and wire cannula 108 have been removed and the half-needle 400 has been inserted through the half-needle cannula 106 into the mobilization segment 50) is illustrated. FIG. 5K The skin and subcutaneous tissue are not illustrated in FIG. 16, but it should be understood that the plate 104 can be located beneath the skin, with the half-needle cannula 106 and half-needle 400 passing through the skin and protruding outwardly. In some embodiments, the half-needle 400 can also be angled back or forward in addition to being angled relative to the top surface 122 of the plate 104.

[0117] FIG. 4 Step 318 of the illustrated method 300 can include removing the half-needle cannula 106. The half-needle cannula 106 can be removed from the opening 130 of the plate 104 using the T-drill guide 500, as FIG. 5LAs shown (skin and subcutaneous tissue not shown). The half-needle drill guide shaft 502 of the T-drill guide 500 can be positioned above the half-needle 400 and the half-needle cannula 106, such that the bottom portion 507 of the opening 506 of the half-needle drill guide shaft 502 is located above a plurality of flat surfaces forming the hexagonal portion 145 of the half-needle cannula 106. The T-drill guide 500 can be rotated to unscrew / remove the thread 149 on the half-needle cannula 106 from the thread 148 in the opening 130 of the plate 104. The T-drill guide 500 can remove the half-needle cannula 106 upward along the longitudinal axis of the half-needle 400. During this process, the physician can use the peripheral drill guide shaft 504 as a handle to manipulate the half-needle cannula 106. FIG. 5M The system after step 318 is shown (i.e., after the half-needle cannula 106 has been removed).

[0118] In some embodiments, the first guidewire 192 may be removed after the half-needle cannula 106 is removed. However, in other embodiments, the first guidewire 192 may be removed before the half-needle cannula 106 is removed. The first guidewire 192 may be removed from the top surface 122 of the plate 104 (see, for example, see...). FIG. 5K Remove upwards and roughly vertically.

[0119] FIG. 4 Step 320 of the method 300 shown may include attaching the tensioner 200 to the half-needle 400 inserted into the transfer section 50. Step 320 is shown in FIG. 5N (Skin and subcutaneous tissue not shown). The half-needle retainers 208, 208' of the upper beam 202 of the tensioner 200 can be placed on the half-needle 400. The half-needle retainers 208, 208' can be moved, rotated, pivoted, or turned to fit onto the inserted half-needle 400, and can be inserted at an angle relative to the surface of the transfer section 50. Nuts 220, 220' of the half-needle retainers 208, 208' (see, for example, [reference needed]). FIG. 5O It can be tightened to secure the half-needle retainers 208, 208' around the half-needle 400 and to fix the tensioner 200 to the half-needle 400.

[0120] FIG. 4 Step 322 of method 300 shown may include inserting a half-needle 400' into the base 52 of the bone near the transport segment 50 and attaching the half-needle 400' to the distractor 200. Step 322 is shown in FIG. 5OThe half-needles 400' inserted into the base 52 can be the same as or different from the half-needles 400 inserted into the mobilization segment 50, as described further below. In some embodiments, the half-needles 400' inserted into the base 52 can be bicortical and can extend through the entire bone, through both cortical layers. Thus, the half-needles 400' inserted into the base 52 can be fixed relative to the half-needles 400 inserted into the mobilization segment 50. The half-needle holder 208 of the lower beam 204 of the distractor 200 can be placed over the half-needles 400' inserted into the base 52. The half-needle holder 208 can be moved, rotated, pivoted, or turned to fit over the inserted half-needles 400', which can be inserted at an angle relative to the surface of the base 52. The nut 220 of the half-needle holder 208 can be tightened to secure the half-needle holder 208 around the half-needles 400' and to secure the distractor 200 to the half-needles 400'. The half-needles 400' can be inserted into the base 52 before or after attachment to the distractor 200. The half-needles 400' can be inserted by any suitable method, including screwing in or tapping in.

[0121] In some embodiments, one or more of the half-needles 400, 400' can be cut or trimmed. The physician can cut or trim the half-needles 400 to make the bone mobilization system easier to operate or to prevent the half-needles 400, 400' from interfering with the distractor 200 during distraction and contraction.

[0122] FIG. 4 The step 324 of the method 300 shown can include removing the plate 104 of the template 100. Because the diameter 146 of the half-needle cannula 106 is greater than the width 138 of the channel 134 of the plate 104, and the width 138 of the channel 134 is greater than the diameter 408 of the half-needle 400 in the mobilization segment 50, the plate 104 cannot be removed until the half-needle cannula 106 is removed (see, e.g., FIG. 1A ). Furthermore, the first guide wire 192 must be removed before the plate 104 can be removed (see, e.g., FIG. 5J ). Once the half-needle cannula 106 and the first guide wire 192 are removed (see, e.g., FIG. 5H to FIG. 5J and FIG. 5L ), the plate 104 can be removed to the side of the mobilization segment 50 in a direction that is substantially perpendicular to the transverse direction in which the second and third guide wires 190, the suture cannula 108, and the half-needle cannula 106 were removed. The plate 104 can be slid off the mobilization segment 50 and removed from under the flap through the opening at the back cut 380 (see, e.g., FIG. 5G ). The plate 104 is removed by moving the channel 134 along the inserted half-needle 400. FIG. 5P The system after step 324 is shown, with the plate 104 of the template 100 removed (see, e.g., FIG. 5O) has been removed, half-pin 400 is inserted into the transport segment 50, half-pin 400' is inserted into the base 52, and distractor 200 is attached to half-pins 400, 400' (skin and subcutaneous tissue not shown).

[0123] FIG. 4 Step 326 of the illustrated method 300 can include cutting the bone to release the transport segment 50. This can include cutting the remaining side of the transport segment 50. The remaining side of the transport segment 50 can be cut after the distractor 200 is attached to the half-pin 400 in the transport segment 50 and the half-pin 400' in the base 52. Once all sides are cut, the transport segment 50 can be moved relative to the base 52 of the bone. In particular, the posterior side of the transport segment 50 can be cut. The posterior side of the transport segment 50 can be easily accessed since the flap is open to the posterior side. In some embodiments, the wound can be closed around the transport segment 50. For example, the flap can be sutured to the adjacent skin.

[0124] FIG. 4 Step 328 of the illustrated method 300 can include turning or rotating the actuator 206 in a first direction to move the transport segment 50 laterally away from the base 52. As described above, the actuator 206 can include a knob 222 and a threaded rod 224 configured to move the upper beam 202 and the lower beam 204 toward or away from each other. When the half-pin 400' inserted into the base 52 is a bicortical insertion, the upper beam 202 can be moved upward relative to the lower beam 204 to move the half-pin 400 inserted into the transport segment 50 upward relative to the half-pin 400' inserted into the base 52. Thus, when the knob 222 of the actuator 206 is rotated in the first direction (i.e., the distraction direction), the transport segment 50 can be moved upward and away from the base 52. FIG. 5Q A bone transport system is shown after the transport segment 50 has been distracted according to step 328 (skin and subcutaneous tissue not shown). In the distracted position, the transport segment 50 has been moved upward and away from the adjacent base 52. In addition, the upper beam 202 and the lower beam 204 are separated from each other, and the threaded rod 224 and the support post 228 are visible in the space between the beams 202, 204.

[0125] FIG. 4 Step 330 of the illustrated method 300 can include rotating the actuator 206 in a second direction to move the transport segment 50 laterally toward the base 52. This step can be performed after or during treatment. When the half-pin 400' inserted into the base 52 is a bicortical insertion, the upper beam 202 can be moved downward relative to the lower beam 204 to move the half-pin 400 inserted into the transport segment 50 downward relative to the half-pin 400' inserted into the base 52. Thus, when the knob 222 of the actuator 206 is rotated in the second direction (i.e., the contraction direction), the transport segment 50 can be moved downward and toward the base 52.

[0126] According to some embodiments of the present disclosure,FIG. 6A A cross-sectional view of the bone into which the half-pins of the mobilization segment 50 and the base 52 are inserted is shown. The bone can include a medullary core within a medullary cavity composed of softer marrow 54, which is surrounded by an outer layer of harder cortical bone 56, 58. In some cases, the half-pins 404 (referred to as half-pins 400' in FIG. 1A to FIG. 5Q the base 52 of the bone can be bicortical, meaning that they extend through both layers of cortical bone of the bone, i.e., the proximal portion 56 and the distal portion 58. The half-pins 402 (referred to as half-pins 400 in FIG. 1A to FIG. 5Q the mobilization segment 50 of the bone can be unicortical, as opposed to bicortical. Thus, the unicortical half-pins 402 can extend partially through the bone, only through the proximal portion 56 of the cortical bone. Thus, the mobilization segment 50 can not penetrate the bone, but only extend partially through the bone. In this way, the mobilization segment 50 can be more easily moved relative to the base 52. For example, the mobilization segment 50 can include a portion of the proximal portion 56 of the cortical bone, but not the marrow in the medullary cavity 54 or the distal portion 58 of the cortical bone.

[0127] In some cases, the half-pins 402 of the mobilization segment 50 are angled at an angle a relative to the surface of the bone. The angle a can be any suitable value. For example, a can be any angle in the range of 0 degrees to 90 degrees. In some embodiments, a can be 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, or 90 degrees. In some embodiments, the half-pins 402 can be disposed at an angle of 15 degrees relative to the surface of the bone. In some cases, the half-pins 402 can be disposed at the same or different angles relative to the surface of the bone. Although the half-pins 402 are shown angled inwardly toward each other, the half-pins 402 can also be angled outwardly away from each other, or angled in the same direction.

[0128] In some cases, the half-pins 404 of the base 52 are angled at an angle β relative to the surface of the bone. The angle β can be any suitable value. For example, β can be any angle in the range of 0 degrees to 90 degrees. In some embodiments, β can be 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, or 90 degrees. In some embodiments, the half-pins 404 can be disposed at an angle of 15 degrees relative to the surface of the bone. In some cases, the half-pins 404 can be disposed at the same or different angles relative to the surface of the bone. Although the half-pins 404 are shown angled inwardly toward each other, the half-pins 404 can also be angled outwardly away from each other, or angled in the same direction.

[0129] According to one or more embodiments, FIG. 6B A side view of the mobilization segment 50 is shown. As described above, the plurality of holes around the perimeter of the plate 104 (see, e.g., FIG. 4) can be configured to receive half-pins 402, 404. In some cases, the half-pins 402, 404 can be inserted into the holes of the plate 104 such that the half-pins 402, 404 are angled inwardly toward each other. FIG. 1A to FIG. 1D) can be angled inward to form the transport segment 50 with a slight chamfer at the bottom, such that the perimeter of the transport segment 50 is angled inward. The angle Θ of the sides of the transport segment can be the same for all sides, or one side can be angled at angle Θ1 and the other side can be angled at angle Θ2. The sides can be angled at any suitable angle Θ. For example, Θ1 and Θ2 can be any angle in the range of 0° to 15°. For example, angle Θ1 and / or angle Θ2 can be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, or 15°. This can prevent the transport segment 50 from interfering with surrounding bone portions 52. The chamfer can also prevent the transport segment 50 from moving downward into the medullary cavity of the bone after cutting.

[0130] FIG. 7A to FIG. 7B Another embodiment of a template 101 for a bone transport system is shown. FIG. 7A is an exploded view of the template 101. FIG. 7B is a bottom view of the upper plate 102 with the snaps 188 disposed therein. Unlike the template 100 shown in FIG. 1A to FIG. 1D , FIG. 7A to FIG. 7B the template 101 shown includes two plates 102, 171: an upper plate 102 and a lower plate 171. FIG. 7A to FIG. 7B The lower plate 171 shown can be substantially similar to the plate 104 shown in FIG. 1A to FIG. 1D The lower plate 171 can have a top surface 172, a bottom surface 176, two end portions 178, and two side portions 180 between the top surface 172 and the bottom surface 176. The plate includes two openings 182 extending through the lower plate 171. The openings 182 can be substantially circular. There can be a channel 186 extending from the opening 182 to one of the side portions 180. However, FIG. 7A to FIG. 7B The lower plate 171 shown can not have the tabs 140. Furthermore, unlike the openings 130 in the plate 104 shown in FIG. 1A to FIG. 1D , FIG. 7A to FIG. 7B The openings 182 in the lower plate 171 shown are not threaded. Furthermore, FIG. 7A to FIG. 7B The extensions 184 of the lower plate 171 shown include grooves 185 for the snaps 188 to couple the upper plate 102 to the lower plate 171, a feature that is not present in the plate 104 shown in FIG. 1A to FIG. 1D

[0131] The upper plate 102 has a top surface 110, a bottom surface 112, two end portions 114, and two side portions 116 between the top surface 110 and the bottom surface 112 and between the two end portions 114. The upper plate 102 can also include an elongated opening 118 extending through the upper plate 102. The elongated opening 118 can be substantially elliptical, but in some cases can be any suitable shape, such as rectangular, oval, egg-shaped, elliptical, or ovate. ​

[0132] The upper plate 102 can include a recess 121 defined in or relative to the bottom surface 112 of the upper plate 102. The recess 121 can be sized and shaped to mate with the lower plate 171. In some cases, the lower plate 171 can be nested in the recess 121 such that it is partially or entirely within the upper plate 102. The recess 121 can be located in the center of the bottom surface 112 or along the end 114 or side 116 of the bottom surface 112. In some embodiments, the recess 121 is not present and the lower plate 171 is located below the upper plate 102. In some embodiments, the width and / or length of the lower plate 171 is less than the width and / or length of the upper plate 102. However, in other embodiments, the width and / or length of the lower plate 171 is greater than or equal to the width and / or length of the upper plate 102.

[0133] The upper plate 102 is configured as a drill guide having a plurality of holes 120 extending through the upper plate 102. The plurality of holes 120 can be arranged around the perimeter of the upper plate 102. In some cases, the plurality of holes 120 can be arranged around the recess 121 of the bottom surface 112 of the upper plate 102. In some embodiments, the plurality of holes 120 can be arranged around only three sides or fewer of the upper plate 102. The plurality of holes 120 in the upper plate 102 can be used as guide holes for drilling holes in the bone to define the perimeter of the mobilization segment 50 (see, e.g., FIG. 1) of the bone, as described in detail below. Thus, for the template shown in FIG. 5P to FIG. 5Q , the T-shaped drill guide 500 shown in FIG. 7A to FIG. 7B may no longer be needed for drilling holes around the mobilization segment 50. FIG. 3A to FIG. 3F

[0134] The opening 182 of the lower plate 171 can be aligned with the elongated opening 118 of the upper plate 102. In some cases, the extension 184 can extend into or through the elongated opening 118.

[0135] The upper plate 102 can also include a tab 115 having a recess 117 at the top and a recess 117 at the bottom. The recess 117 can enable a physician to easily grasp and / or manipulate the upper plate 102 with a hand or a tool (e.g., a forceps) (not shown).

[0136] In some embodiments, the plurality of holes 120 around the perimeter of the template 100 can be angled inward to form a mobilization segment 50 with a slight chamfer at the bottom as shown in FIG. 6A to FIG. 6B . Thus, the plurality of holes 120 can be angled to form a mobilization segment 50 as described with reference to FIG. 6A to FIG. 6B .

[0137] ​In some embodiments, the upper plate 102 can include protrusions 142 protruding into the recess 121 from the bottom surface 112 or the walls of the recess 121. The protrusions 142 can define cavities 141 configured to fit the snaps 188. Thus, the cavities 141 of the protrusions 142 on the upper plate 102 and the snap recesses 185 of the extensions 184 on the lower plate 171 can only allow the lower plate 171 to be inserted into the upper plate 102 in one orientation. In some embodiments, the snaps 188 can enable the lower plate 171 to snap into or out of the recess 121 of the upper plate 102.

[0138] FIG. 8A to FIG. 8B Another embodiment of a distractor 890 is shown in accordance with some embodiments of the present disclosure. FIG. 8A is a perspective view of a distractor 890, FIG. 8B is a perspective view of the distractor 890 after removal of the motor cover 897. FIG. 8A to FIG. 8B The distractor 890 shown is similar to the distractor 200 shown in FIG. 2A to FIG. 2D The distractor 200 shown is similar to the distractor 890 shown in FIG. 8A to FIG. 8B The distractor 890 shown includes the same upper beam 202, lower beam 204, and half needle holders 208, 208'. However, FIG. 8A to FIG. 8B The distractor 890 in FIG. 1 uses an electrically actuated mechanism 896. FIG. 8A to FIG. 8B The actuation mechanism shown uses an electric actuator 896 with gears 891, 892 to move the distractor 890 between the distraction and retraction positions. The actuator 896 has a drive shaft with a first gear 891. The actuator 896 can be powered in any suitable manner. For example, the actuator 896 can be a battery powered electric motor. The first gear 891 is engaged with a second gear 892. The second gear 892 is coupled to a threaded rod 893 that extends through the upper beam 202 and the lower beam 204. The threaded rod 893 can be supported on both sides by support posts 895 to enhance stability. A motor cover 897 can be formed and configured to cover the gears 891, 892 of the electric motor 896. The electric motor 896 can be operatively coupled to a power source 898 and a processor circuit 899. The first gear 891 can be driven to rotate by the power source 898. This can cause the second gear 892 to rotate, thereby causing the threaded rod 893 to move up or down to move the upper beam 202 and the lower beam 204 relative to each other. In some cases, rotation of the first gear 891 in a first direction causes the upper beam 202 and the lower beam 204 to move away from each other (distraction), while rotation of the first gear 891 in a second direction causes the upper beam 202 and the lower beam 204 to move toward each other (retraction).

[0139] In some embodiments, the processor circuit 899 can include a processor and a memory storing computer readable instructions. The processor circuit 899 can be operatively coupled to the power source 898 and / or the motor 896 to control the movement of the motor 896. For example, the processor circuit 899 can cause the first gear 891 to rotate in a first direction to effect distraction, or in a second direction to effect contraction.

[0140] The processor circuit 899 can include a wireless communication module enabling the processor circuit 899 to communicate with a remote computer system wirelessly, for example, through Wi-Fi or Bluetooth. The computer system can send control signals to the wireless communication module to control the power source 898 and / or the motor 896.

[0141] In some embodiments, the lateral bone transport device can include an electric engine with an automatic controller of distraction / compression module, which can include a sinusoidal rate of distraction and compression.

[0142] In some embodiments, the distractor 890 includes one or more sensors to measure, for example, blood volume, blood flow, vascularization / neovascularization, strain, displacement, or any other suitable measurement. The processor circuit 899 can store and / or send the measurement data obtained by the one or more sensors to a remote computer system. These measurement data can be analyzed by a processor within the processor circuit 899 or by the computer system. For example, the processor circuit 899 / computer system can compare the measurement data with stored program values and control the distraction, compression, and remodeling during the consolidation of healing based on the comparison result. The measurement data, as well as optional other data (e.g., patient data), can be used to predict, determine, or suggest a treatment regimen. The power source 898 and / or the motor 896 can then operate according to the treatment regimen. In some embodiments, artificial intelligence (AI) can be used to analyze one or more measurements to predict a treatment regimen. An AI model can analyze the correlation between physiological data detected on a patient and data reported in clinical studies, make suggestions to a physician for different treatment parameter adjustments than originally planned during the course of treatment. The AI model can also indicate abnormalities between standard physiological parameters in the treatment and patient-detected parameters. For example, if the oxygenation level in the surrounding soft tissue is higher than a set value, the AI module can adjust the transport rate (e.g., from the standard 1 millimeter per day to 0.25 millimeters per day), thereby reducing the oxygenation level to provide better conditions for neovascularization. Alternatively, in another example, when enhanced neovascularization around the transport segment is detected, the lateral transport rate can be increased, thereby avoiding premature bone healing between the transport segment and the surrounding bone by increasing the daily movement of the transport segment, thereby preventing interruption of bone transport.

[0143] In some embodiments, the transverse bone transport system can provide other treatments in addition to bone transport. For example, the bone transport system can include a module for delivering a chemical / biological agent. In some embodiments, the transverse bone transport device can include a module for mechanically stimulating neovascularization and increasing blood volume and flow.

[0144] In some embodiments, the distractor can be attached to both the bone and the ring 900 for an external fixation system through the half pins 400. FIG. 9A A distractor 200 is shown coupled to the bone and the ring 900. FIG. 9A The distractor 200 in FIG. 2A is the same as the distractor 200 shown in FIG. 2A to FIG. 2D FIG. 2B, and thus its components / parts are not discussed in detail here (see the discussion above). The upper beam 202 of the distractor 200 is attached to two half pins 400 inserted into the transport segment 50. However, the lower beam 204 is attached to only one half pin 400' inserted into the base 52 at one end of the transport segment 50. At the other end of the transport segment 50, the lower beam 204 is attached to one end of a ring connector 902. The ring connector 902 is attached to the ring 900 at the other end. In some embodiments, the ring connector 902 includes a threaded rod 903 and two bolts 904. The threaded rod 903 can be attached to the lower beam 204 of the distractor 200 by inserting the threaded rod 903 into the half pin holder 208 and tightening the half pin holder 208. The half pin holder 208 can need to be rotated more than when attached to the half pin 400'. For example, in the illustrated embodiment, the threaded rod 903 is oriented approximately parallel to the lower beam 204. However, the half pin holder 208 is tightened around the threaded rod 903 in substantially the same manner.

[0145] The threaded rod 903 can extend through a hole in the ring 900. The bolts 904 can threadably engage the threaded rod 903 on both sides of the ring 900. Thus, the bolts 904 can be tightened on both sides of the ring 900 to secure the ring 900 between the bolts 904.

[0146] Once the distractor 200 is secured to the half pins 400, 400' and the ring 900, the distraction and contraction operations of the distractor 200 are the same as described above with reference to FIG. 2A to FIG. 2D FIG. 2A.

[0147] In some embodiments, the distractor 200 can be attached to both the transport segment 50 of the bone and two rings 900 for an external fixation system through the half pins 400. FIG. 9B A distractor 200 is shown coupled to the bone and the two rings 900. FIG. 9B The distractor 200 in FIG. 2A is the same as the distractor 200 shown in FIG. 2A to FIG. 2D FIG. 2B, and thus its components / parts are not discussed in detail here (see the discussion above). In addition, FIG. 9A the ring connector 902 shown in FIG. 2B is the same as the ring connector 902 shown inFIG. 9B The ring connectors 902 shown are identical. As with the FIG. 9A staple segment 50 inserted into bone. In FIG. 9B the two end portions 212 of the lower beam 204 are coupled to the ring 900 by ring connectors 902, as described above. Once the distractor 200 is secured to the half pins 400 and the ring 900, the distraction and contraction operations of the distractor 200 are identical to those described above with respect to the FIG. 2A to FIG. 2D distractor 100.

[0148] While FIG. 9A to FIG. 9B the distractor 200 shown is a two-beam distractor, it should be understood that any suitable distractor (including the FIG. 2A to FIG. 2D distractor 890 shown) can be used with one or more rings 900. FIG. 8A to FIG. 8B

[0149] Embodiments of various templates according to embodiments described herein are shown. FIG. 10A to FIG. 10L is an example of a template 660 having two openings 661 for fitting the half pins 400 and a plurality of holes 662. FIG. 10A

[0150] is a side view of a template 666. The template 666 includes an opening 664 having an extension 665 extending upward from the top of the template 666. The opening 664 can be unangled and oriented generally perpendicular to the top and bottom surfaces of the template 666. FIG. 10B is an example of a template 667, which is similar to the FIG. 10C template 666 shown. In FIG. 10B the template 667 shown, the opening 664 is angled relative to the top and bottom surfaces of the template 667. The opening 664 can be angled outward toward the ends of the template 667. FIG. 10C

[0151] An example of a template 668 is shown. FIG. 10D The template 668 in includes a plurality of holes 669 around the perimeter of the template 668, as well as a plurality of rows of holes 670 from holes 669 on one side of the template 668 to holes on the other side. This allows a single template 668 to be used to measure and cut a variety of sizes of staple segments 50 (see, e.g., FIG. 10D ). FIG. 5P to FIG. 5Q is an example of a template 672 including a plurality of holes 673 around the perimeter of the template 672. The plurality of holes 673 can be connected by a series of channels. Thus, the template 672 can be used to drill holes in a staple segment 50 and cut between the holes to form a staple segment 50 (see, e.g., FIG. 10E ). FIG. 5P to FIG. 5Q

[0152] FIG. 10F ​is an example of a template 674 that is comprised of two parts. The template includes two angled openings 675 and a break 676 between the two openings 675. Thus, the openings 675 can be on separate parts of the template 674. The break 676 can extend from one side of the template 674 to the other. In some cases, the break 676 can be a straight line. FIG. 10G A top view of a template 674 is shown, where the break 676 is not a straight line. Rather, one part includes a protrusion 677 and the other part includes a groove 678 that mates with the protrusion 677. FIG. 10G The shape of the template 674 can provide additional stability and prevent the two parts from moving relative to each other. FIG. 10H A two-part template 680 is shown, where the openings 681 are disposed along a break 682 and a hinge 683 is disposed between the two parts at one end of the template 680.

[0153] FIG. 10I A top view of an example of a two-part template 684 is shown. The template 684 includes two openings 685 disposed along a break 686 that extends from one end of the template 684 to the other. A hinge or lock plate 687 is disposed along the break 686 that allows the two parts to move apart from each other and away from each other.

[0154] FIG. 10J to FIG. 10L A two-part template 688 is shown that is similar to the template 101 shown. FIG. 7A to FIG. 7B The template 688 includes an upper plate 689 and a lower plate 690. The lower plate 690 can be embedded in a groove 693 in the bottom of the upper plate 689. The upper plate 689 includes two elongated openings 691 and the lower plate 690 includes two openings 692 that can not be elongated. The lower plate 690 can also include a channel 694 that extends from the openings 692 to one side of the lower plate 690. The upper plate 689 can include a plurality of holes 695 disposed around the perimeter and the groove 693.

[0155] While various embodiments have been described in connection with the disclosure provided herein, it should be understood that the embodiments described are merely examples in accordance with the disclosure and are not limiting. Therefore, the breadth and scope of the disclosure should not be limited by any of the above described embodiments, but should be defined in accordance with the following claims supported by their equivalents. Furthermore, the above advantages and features are provided in the described embodiments, but should not limit the applicability of the claims to the processes and structures achieving any or all of the above advantages.

Claims

1. A template for a lateral bone transport system, comprising: a plate, the plate comprising: a top surface; a bottom surface opposite the top surface; a first side; a second side opposite the first side; a first opening extending from the top surface to the bottom surface; and a channel extending between the top surface and the bottom surface and between the first opening and the first side of the plate, wherein a width of the channel is less than a width of the first opening; and a needle cannula configured to fit within the first opening, wherein an outer width of the needle cannula is greater than the width of the channel.

2. The template of claim 1, further comprising a wire cannula configured to fit within the needle cannula.

3. The template of claim 2, wherein, an inner width of the wire cannula is less than an inner width of the needle cannula.

4. The template of claim 1, wherein, the first opening is angled toward an end of the plate such that when the needle cannula is disposed in the first opening, the needle cannula is angled relative to the top surface of the plate.

5. The template of claim 1, wherein the plate further comprising: a first end extending between the first side and the second side; a second end opposite the first end extending between the first side and the second side; and a plurality of corners between the first side, the first end, the second side, and the second end; and wherein the template further comprises a drill guide, the drill guide comprising: a guide axis; a guide opening aligned with the guide axis; and an alignment structure configured to engage with a first corner of the plurality of corners, the alignment structure comprising: a first guide wall configured to engage with one of the first side or the second side; a second guide wall configured to engage with one of the first end or the second end; and a base surface configured to engage with the top surface, wherein when the alignment structure engages with the first corner of the plate, the guide axis is angled relative to the top surface of the plate.

6. The template of claim 1, further comprising: a second opening extending from the top surface to the bottom surface; a second channel extending between the top surface and the bottom surface and between the second opening and the first side of the plate; and a needle guide aperture extending from the top surface to the bottom surface and disposed on a longitudinal axis between the first opening and the second opening. the plate further comprising an extension extending upward around at least a portion of the first opening.

7. The template of claim 1, wherein, 8. A distractor for a lateral bone transport system, comprising: a first beam comprising a first opening and a first movable half-needle holder; a second beam comprising a second opening and a second movable half-needle holder, wherein a length of the second beam is greater than a length of the first beam, wherein the first movable half-needle holder and the second movable half-needle holder are offset in a longitudinal direction and a radial direction; and an actuator comprising a knob and a threaded rod disposed within the first opening of the first beam and the second opening of the second beam, wherein the knob is configured to rotate in a first direction to increase a distance between the first beam and the second beam and to rotate in a second direction to decrease the distance between the first beam and the second beam. the actuator is rotatable through a plurality of discrete rotational positions.

9. The distractor of claim 8, wherein, ​ 10. The distractor of claim 9, wherein, Each of the plurality of discrete rotational positions is separated from an adjacent discrete rotational position by a set distance.

11. The distractor of claim 10, wherein, The set distance corresponds to a discrete lateral distance between the first beam and the second beam.

12. The distractor of claim 8, wherein, The first and second moveable half needle retainers are configured to pivot between a plurality of angular positions.

13. The distractor of claim 12, wherein, The first moveable half needle retainer is configured to retain a first needle, wherein the first moveable half needle retainer is configured to tighten around the first needle such that the first needle is retained in a first angular position of the plurality of angular positions.

14. The distractor of claim 13, wherein, The second moveable half needle retainer is configured to retain a second needle, wherein the second moveable half needle retainer is configured to tighten around the second needle such that the second needle is retained in a second angular position of the plurality of angular positions.

15. The distractor of claim 14, wherein, The first angular position is different than the second angular position.

16. The distractor of claim 8, wherein, The threaded rod is threadably fitted in the second beam such that the actuator is configured to move the first beam relative to the second beam.

17. The distractor of claim 8, further comprising a support post coupled to at least one of the first beam or the second beam and disposed proximate the threaded rod.

18. A kit for a lateral bone transport system, comprising: a template, the template comprising: a plate, the plate comprising: a top surface; a bottom surface opposite the top surface; a first side; a second side opposite the first side; an opening extending from the top surface to the bottom surface; and a channel extending between the top surface and the bottom surface and extending between the opening and the first side of the plate, wherein a width of the channel is less than a width of the opening; and a needle cannula configured to fit in the opening, wherein an outer width of the needle cannula is greater than the width of the channel; a distractor, the distractor comprising: a first beam comprising a first opening and a first moveable half needle retainer; a second beam comprising a second opening and a second moveable half needle retainer, wherein a length of the second beam is greater than a length of the first beam, wherein the first and second moveable half needle retainers are longitudinally offset; and an actuator comprising a knob and a threaded rod disposed within the first opening of the first beam and the second opening of the second beam, wherein the knob is configured to be rotated in a first direction to increase a distance between the first beam and the second beam and in a second direction to decrease the distance between the first beam and the second beam; and a plurality of needles.

19. The kit of claim 18, wherein, the plate further comprising: a first end extending between the first side and the second side; a second end opposite the first end and extending between the first side and the second side; and a plurality of corners between the first side, the first end, the second side, and the second end; and wherein the kit further comprises a drill guide, the drill guide comprising: a guide axis; a guide opening aligned with the guide axis; and an alignment structure configured to engage with a first corner of the plurality of corners and comprising: a first surface; and a second surface opposite the first surface. a first guide wall configured to engage one of the first side or the second side; a second guide wall configured to engage one of the first end or the second end; and a base surface configured to engage the top surface, wherein the guide axis is angled relative to the top surface of the plate when the alignment structure engages the first corner of the plate.

20. The kit of claim 18, wherein, a width of at least one of the plurality of needles is less than a width of the channel.

21. A method of performing a bone transport, comprising: positioning a template on a transport segment of a bone, wherein the template comprises: a plate comprising: a top surface; a bottom surface opposite the top surface; a first side; a second side opposite the first side; holding the template in a first position relative to the bone; forming a plurality of holes in the bone adjacent at least the first side and the second side using the template; and cutting the transport segment from the bone using the plurality of holes.

22. The method of claim 21, wherein, forming the plurality of holes in the bone using the template comprises engaging the template with a drill guide and passing a drill bit through the drill guide to form the plurality of holes.

23. The method of claim 21, wherein, the template further comprises a needle guide aperture, and wherein the method further comprises inserting a first guide wire through the needle guide aperture.

24. The method of claim 21, further comprising: inserting a half-needle into the transport segment through a needle cannula attached to the template after positioning the template on the transport segment.

25. The method of claim 24, wherein, the template comprises a first opening for receiving the needle cannula, and the needle cannula comprises a second opening, and wherein the template further comprises a wire cannula configured to be inserted into the second opening of the needle cannula and comprising a third opening.

26. The method of claim 25, further comprising: inserting a second guide wire into the transport segment of the bone through the third opening of the wire cannula before inserting the half-needle into the transport segment through the needle cannula.

27. The method of claim 26, further comprising: after inserting the second guide wire through the third opening of the wire cannula, passing a flap over the template and the second guide wire, wherein the wire cannula extends through a hole in the flap.

28. The method of claim 26, further comprising: after inserting the second guide wire into the transport segment of the bone through the third opening of the wire cannula, removing the second guide wire and the wire cannula.

29. The method of claim 24, further comprising: after cutting the transport segment, removing the needle cannula upward along a longitudinal axis of the half-needle.

30. The method of claim 29, further comprising: after removing the needle cannula, removing the plate laterally along an axis substantially perpendicular to the longitudinal axis of the half-needle.

31. A distractor for a transverse bone transport system, comprising: a first beam comprising a first opening and a first movable half-needle holder; a second beam comprising a second opening and a second movable half-needle holder, wherein a length of the second beam is greater than a length of the first beam, wherein the first movable half-needle holder and the second movable half-needle holder are longitudinally and radially offset; and an electric actuator comprising: a threaded rod disposed within the first opening of the first beam and the second opening of the second beam; and an electric motor operably coupled to the threaded rod such that the electric motor is configured to rotate the threaded rod in a first direction to increase a distance between the first beam and the second beam and in a second direction to decrease the distance between the first beam and the second beam.

32. The distractor of claim 31, wherein, The actuator further comprises: a first gear coupled to the electric motor such that the electric motor is configured to rotate the first gear; and a second gear meshed with the first gear such that when the electric motor rotates the first gear, the first gear is configured to rotate the second gear, wherein the second gear is coupled to the threaded rod such that when the first gear rotates the second gear, the second gear is configured to rotate the threaded rod.

33. The distractor of claim 32, further comprising: a power source; and a processor circuit operably coupled to at least one of the electric motor or the power source, wherein the processor circuit is configured to control at least one of the electric motor or the power source.

34. The distractor of claim 33, further comprising one or more sensors configured to acquire measurement data and transmit the data to the processor circuit.

35. The distractor of claim 34, wherein, The processor circuit is configured to receive the acquired measurement data from the one or more sensors.

36. The distractor of claim 35, wherein, The processor circuit comprises an artificial intelligence program that generates a treatment protocol using the acquired measurement data.

37. The distractor of claim 36, wherein, The processor circuit is configured to control at least one of the power source or the electric motor according to the generated treatment protocol.

38. The distractor of claim 35, wherein, The processor circuit is configured to transmit the acquired measurement data to a computer system.

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