Bone transport system and method

Abstract

A system, method, and apparatus for lateral bone transport. The lateral bone transport system may include a template for measuring and cutting a portion of bone, and a distractor for moving this portion. The template may include a plate including an opening configured to fit a pin sleeve. A channel may extend from the opening in the plate to the side of the plate. The distractor may include a first beam, a second beam, and an actuator including a knob configured to rotate in a first direction to increase the 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

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the benefit of U.S. Provisional Application No. 63 / 506,888, filed Jun. 8, 2023.

[0002] The present disclosure generally relates to bone transport systems, and more particularly, to templates, distractors, and pins used in bone transport systems, and methods of using bone transport systems.

Background Art

[0003] Foot ulcers are a common problem in patients with poorly managed diabetes or peripheral arterial disease. Transverse bone transport is a method of treating those foot ulcers. In transverse bone transport, a portion of the bone in the leg, often the tibia, where the ulcer is located, is cut and moved away from the axis of the bone, i.e., moved transversely. This method may also be known as the Ilizarov technique. By applying continuous tension to bone tissue, transverse bone transport can increase blood circulation and promote active angiogenesis of the bone and the entire limb by stimulating the growth of new blood vessels in the tissue between the moving and the body parts of the bone. This can improve the healing of foot ulcers due to diabetes and peripheral arterial disease in the lower extremities.

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, transverse bone transport systems can be difficult or inconvenient for surgeons to apply and for patients to use. Furthermore, the procedure of transverse bone transport can cause pain or discomfort to the patient. Therefore, an improved transverse bone transport system is needed.

Means for Solving the Problems

[0005] This disclosure describes apparatus, systems, and methods for lateral bone transport. Some embodiments of this disclosure include templates for generating bone transport segments and for mounting the bone segments to a lateral bone transport apparatus for lateral bone transport. The template may include a plate having a top surface, a bottom surface, a first side surface, a second side surface opposite the first side surface, 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 surface. The width of the channel may be less than the width of the first opening. Furthermore, the template may include a pin sleeve configured to fit into the first opening. The outer width of the pin sleeve may be greater than the width of the channel.

[0006] In some embodiments, the template may include a wire sleeve configured to fit into a pin sleeve. In some embodiments, the outer width of the wire sleeve may be smaller than the inner width of the pin sleeve. In some embodiments, the template may include a drill bit sleeve configured to fit into a pin sleeve. In some embodiments, the outer width of the drill bit sleeve may be smaller than the inner width of the pin sleeve. In some embodiments, the first opening may be inclined toward the edge of the plate such that when the pin sleeve is placed in the first opening, the pin sleeve is inclined toward the top surface of the plate. In some embodiments, the plate may further include a first end extending between a first side and a second side, a second end opposite to 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. In some embodiments, the template may further include a drill guide including 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 may include a first guide wall configured to engage with either a first or second side, a second guide wall configured to engage with either a first or second end, and a base surface configured to engage with the top surface. When the alignment structure engages with a first corner of the plate, the guide axis can be inclined with respect to the top surface of the plate.

[0007] In some embodiments, the template further includes a second opening extending from the top to the bottom; a second channel extending between the top and bottom and between the second opening and a first side of the plate; and a guide pin opening extending from the top to the bottom and positioned on the longitudinal axis between the first and second openings. In some embodiments, the plate further includes an extension extending upward around at least a portion of the first opening.

[0008] Some embodiments of the present disclosure include a distractor mechanism or distractor for a lateral bone transport system. The distractor may include a first beam, which may include a first opening and a first movable half-pin holder. Furthermore, the distractor may include a second beam, which may include a second opening and a second movable half-pin holder. The length of the second beam may be greater than the length of the first beam. The first and second movable half-pin holders may be displaced longitudinally and radially. Furthermore, the distractor may include an actuator, which may include a knob and a screw rod positioned within the first and second beams. The knob may be configured to rotate in a first direction to increase the distance between the first and second beams and to rotate in a second direction to decrease the distance between the first and second beams.

[0009] In some embodiments, the actuator may be rotatable through a plurality of discrete rotational positions. In some embodiments, each of the plurality of discrete positions may be located at a predetermined distance from an adjacent discrete position. In some embodiments, the predetermined distance may correspond to a discrete lateral distance between a first beam and a second beam.

[0010] In some embodiments, the first and second movable half-pin holders may be configured to pivot between a plurality of angular positions. In some embodiments, the first movable half-pin holder may be configured to hold a first pin, and the first movable half-pin holder may be configured to clamp around the first pin so that the first pin is held in a first angular position among a plurality of angular positions. In some embodiments, the second movable half-pin holder may be configured to hold a second pin, and the second movable half-pin holder may be configured to clamp around the second pin so that the second pin is held in a second angular position among a plurality of angular positions. In some embodiments, the first and second angular positions are different. In some embodiments, a threaded rod may be screwed into and received on the second beam so that the actuator can be configured to move the first beam relative to the second beam. In some embodiments, the distractor may further include a support column coupled to at least one of the first or second beams, the support column positioned in close proximity to the threaded rod.

[0011] In some embodiments, the first and second movable half-pin holders may include screw shafts positioned in the first and second openings of the first and second beams, respectively, such that the pin is held in one of a plurality of angular positions, and fastened by the first and second half-pin holder nuts. In some embodiments, the first and second beams may include slotted first and second openings for receiving the pin holders. In some embodiments, the vertical slot may include an outer spherical surface adjacent to the slot, having a convex surface on one side for engaging with the movable half-pin holder and a corresponding concave surface on the opposite side for engaging with the fastening nut. In some embodiments, the first and second half-pin holder fastening nuts may include convex surfaces that match the concave surface of the vertical slot spherical portion of the first and second beams. In some embodiments, the first and second beams may include horizontal or oblique slotted openings for the movable half-pin holders, thereby providing flexibility in the distance between the traction mechanism and the skin.

[0012] Some embodiments of the present disclosure may include a kit for a lateral bone transport system. The kit may include a template, a distractor, and a number of pins. The template may also include a plate, which includes a top surface, a bottom surface, a first side surface, a second side surface opposite the first side surface, an opening extending from the top surface to the bottom surface, and a channel extending between the top and bottom surfaces of the lower plate and between the opening and the first side surface. The width of the channel may be less than the width of the opening. Furthermore, the template may include a pin sleeve configured to fit into the opening. The outer width of the pin sleeve may be greater than the width of the channel. The distractor may include a first beam, which may include a first opening and a first movable half-pin holder. Furthermore, the distractor may include a second beam, which may include a second opening and a second movable half-pin holder. The length of the second beam may be greater than the length of the first beam. The first and second beams may be displaced longitudinally. Furthermore, the distractor may include an actuator comprising a knob and a screw rod positioned within the first and second beams. The knob may be configured to rotate in a first direction to increase the distance between the first and second beams and to rotate in a second direction to decrease the distance between the first and second beams.

[0013] In some embodiments, the plate may further include a first end extending between a first side and a second side, a second end opposite to 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. In some embodiments, the template may further include a drill guide including 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 may include a first guide wall configured to engage with either the first or second side, a second guide wall configured to engage with either the first or second end, and a base surface configured to engage with the top surface. When the alignment structure engages with the first corner of the plate, the guide axis can be tilted relative to the top surface of the plate. In some embodiments, the width of at least one of the plurality of pins is smaller than the width of the channel.

[0014] Some embodiments of the present disclosure include a method for performing bone transport. The method may include placing a template on a transport segment of bone, the template including a plate having a top surface, a bottom surface opposite the top surface, a first side surface, and a second side surface opposite the first side surface. Furthermore, the method may include holding the template in a first position relative to the bone. Furthermore, the method may include using the template to form a plurality of holes in the bone adjacent to at least the first and second sides. Furthermore, the method may include using the plurality of holes to cut the transport segment from the bone.

[0015] In some embodiments, forming multiple holes in bone using a template may include engaging the template with a drill guide and passing a drill bit through the drill guide to form multiple holes. In some embodiments, the template may include a guide pin opening, and the method may further include inserting a first guide wire through the guide pin opening.

[0016] In some embodiments, the method may further include inserting a half-pin into the transport segment through a pin sleeve attached to the template after the template has been placed on the transport segment. In some embodiments, the template may include a first opening for receiving the pin sleeve, and the pin sleeve may include a second opening. In some embodiments, the template may include a wire sleeve having a third opening, configured to be inserted into the second opening of the pin sleeve. In some embodiments, the method may further include inserting a second guidewire into the bone transport segment through a third opening of the wire sleeve before inserting a half-pin into the transport segment through the pin sleeve. In some embodiments, after inserting the second guidewire through the third opening of the wire sleeve, the method may further include passing a skin flap over the template and the second guidewire, extending the wire sleeve through a hole in the skin flap. In some embodiments, after inserting the second guidewire into the bone transport segment through the third opening of the wire sleeve, the method may further include removing the second guidewire and the wire sleeve. In some embodiments, after incising the transport segment, the pin sleeve may be removed upward along the longitudinal axis of the half-pin. In some embodiments, the method may further include removing the plate laterally along an axis substantially perpendicular to the longitudinal axis of the half-pin after removing the pin sleeve.

[0017] Some embodiments of the present disclosure may include a distractor for a lateral bone transport system. The distractor may include a first beam including a first opening and a first movable half-pin holder, and a second beam including a second opening and a second movable half-pin holder. The length of the second beam may be greater than the length of the first beam. The first and second movable half-pin holders may be displaced longitudinally and radially. Furthermore, the distractor may include an electric actuator including a screw rod positioned in a first opening in the first beam and a second opening in the second beam, and a motor operably coupled to the screw rod. The motor may be configured to rotate the screw rod in a first direction to increase the distance between the first and second beams, and in a second direction to decrease the distance between the first and second beams.

[0018] In some embodiments, the actuator may include a first gear coupled to a motor so as to be rotated by the motor, and a second gear in contact with the first gear so as to be rotated by the first gear when the motor rotates the first gear. The second gear may be coupled to a screw rod such that the second gear rotates the screw rod when the first gear rotates the second gear. In some embodiments, the distractor may further include a power supply and a processor circuit operably coupled to the motor or at least one of the power supply, the processor circuit being configured to control the motor or at least one of the power supply. In some embodiments, the distractor may further include more sensors configured to acquire measurement data and transmit the data to the processor circuit. In some embodiments, the processor circuit may be configured to receive measurement data acquired from one or more sensors. In some embodiments, the processor circuit may include an artificial intelligence program that uses the acquired measurement data to generate a treatment protocol. In some embodiments, the processor circuit may be configured to control the power supply or at least one of the motor according to the generated treatment protocol. In some embodiments, the processor circuit may be configured to transmit the acquired measurement data to a computer system. In some embodiments, the processor circuit can control the motor according to sinusoidal traction and compression speeds, or at least one of them. In some embodiments, the lateral bone transport device may include a plurality of sensors for measuring blood volume, blood flow velocity, angiogenesis / neovascularization, strain, or displacement.

[0019] In some embodiments, a distractor mechanism for horizontal bone transport can be used in combination with a circular or semi-circular external fixation device. In some embodiments, the distractor mechanism may be directly attached to the circular or semi-circular external fixation device. In some embodiments, a movable half-pin holder can be utilized to attach to the circular or semi-circular external fixation device.

[0020] In some embodiments, a horizontal bone transport device can include a module for the delivery of chemical / biological agents.

[0021] In some embodiments, a horizontal bone transport device can include a module for mechanical stimulation of neovascularization and for increasing blood volume and blood flow.

[0022] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0023] Here, to more fully understand the present disclosure and its advantages, reference is made to the following description in conjunction with the accompanying drawings. In the drawings, like reference numerals indicate like features.

Brief Description of the Drawings

[0024] [Figure 1A] It is an exploded view of a template of a bone transport system according to some embodiments of the present disclosure. [Figure 1B] It is a side view of the assembled state of the template shown in FIG. 1A. [Figure 1C] It is a perspective top view of the assembled state of the template shown in FIG. 1A excluding the wire sleeve. [Figure 1D] It is a perspective bottom view of the plate of the template shown in FIG. 1A. [Figure 1E] It is a perspective view of a drill sleeve of a template according to some embodiments of the present disclosure. [Figure 2A]Perspective front view of the distractor of the bone transport system according to some embodiments of the present disclosure. [Figure 2B] Top view of the distractor shown in FIG. 2A. [Figure 2C] Perspective rear view of the distractor shown in FIG. 2A. [Figure 2D] Exploded view of the distractor shown in FIG. 2A. [Figure 3A] Perspective front view of the T-shaped drill guide according to some embodiments of the present disclosure. [Figure 3B] Perspective side view of the T-shaped drill guide shown in FIG. 3A. [Figure 3C] Perspective bottom view of the T-shaped drill guide shown in FIG. 3A. [Figure 3D] Perspective side view of the T-shaped drill guide shown in FIG. 3A, and according to some embodiments of the present disclosure, it is used for inserting a drill bit and drilling a hole near the corner of the plate of the template. [Figure 3E] Perspective bottom view of the T-shaped drill guide shown in FIG. 3A, and according to some embodiments of the present disclosure, it is used for drilling a hole near the corner of the plate of the template. [Figure 3F] Perspective side view of the T-shaped drill guide shown in FIG. 3A, and according to some embodiments of the present disclosure, it is used for inserting a drill bit and drilling a hole near the side of the plate of the template. [Figure 4] Flowchart showing a method of using a bone transport system according to some embodiments of the present disclosure. [Figure 5A] Showing various steps in the method of FIG. 4 according to some embodiments of the present disclosure. [Figure 5B] Showing various steps in the method of FIG. 4 according to some embodiments of the present disclosure. [Figure 5C] Showing various steps in the method of FIG. 4 according to some embodiments of the present disclosure. [Figure 5D]The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5E] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5F] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5G] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5H] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5I] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5J] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5K] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5L] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5M] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5N] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5O] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5P] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 5Q] The various steps in the method shown in Figure 4 according to several embodiments of this disclosure are shown. [Figure 6A] This is an illustration showing a cross-sectional view of a bone into which a half-pin has been inserted, according to some embodiments of the present disclosure. [Figure 6B]This is an illustration showing a side view of a bone transport segment according to several embodiments of the present disclosure. [Figure 7A] This disclosure illustrates another embodiment of the template according to several embodiments. [Figure 7B] This disclosure illustrates another embodiment of the template according to several embodiments. [Figure 8A] Some embodiments of the present disclosure illustrate another embodiment of the distractor. [Figure 8B] Some embodiments of the present disclosure illustrate another embodiment of the distractor. [Figure 9A] Figures 2A to 2D show some embodiments of the present disclosure of a distractor connected to a half-pin and a ring. [Figure 9B] Figures 2A to 2D show a distractor connected to a half-pin and two rings according to several embodiments of the present disclosure. [Figure 10A] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10B] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10C] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10D] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10E] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10F] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10G] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10H] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10I]This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10J] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10K] This disclosure illustrates various embodiments of the template according to several embodiments. [Figure 10L] This disclosure illustrates various embodiments of the template according to several embodiments. [Modes for carrying out the invention]

[0025] For convenience, the same reference numerals may be used to refer to similar elements, but it will be understood that each of the various embodiments may be considered a distinct variation.

[0026] Next, exemplary embodiments are described below with reference to the accompanying drawings, which form part of this specification and illustrate several examples of how exemplary embodiments and their equivalents can be carried out. When used in this disclosure and the accompanying claims, the terms “embodiment,” “example of embodiment,” and “exemplary embodiment” do not necessarily refer to a single embodiment, but may refer to a single embodiment, and various examples of embodiments and their equivalents can be easily combined and substituted without departing from the scope or spirit of this embodiment. Furthermore, the terms used herein are intended solely to illustrate examples of embodiments and are not intended to limit embodiments. In this regard, when used herein, unless otherwise defined, the term “plate” can refer to any substantially flat structure or any other three-dimensional structure and their equivalents, including structures having one or more parts that are not substantially flat along one or more axes. Furthermore, as used herein, unless otherwise defined, the terms “opening,” “recess,” and “opening,” and their equivalents, are substantially circular, elliptical, square, rectangular, hexagonal, and / or any other shape, and / or combinations thereof, and may include any holes, spaces, regions, recesses, channels, slots, cavities, and their equivalents that may be defined by a partial, substantial, or complete perimeter of the material surface. Furthermore, as used herein, the term “in” may include “in” and “on,” and the terms “a,” “an,” and “the” may include singular and plural references. Furthermore, as used herein, the term “by” may, depending on the context, mean “from.” Furthermore, as used herein, the term “if” may, depending on the context, mean “when” or “upon.”Furthermore, as used herein, the term "and / or" may refer to and encompass any possible combination of one or more of the items listed in relation to each other.

[0027] Furthermore, the headings in this specification are presented in accordance with the suggestions of Section 1.77 of Title 37 of the Code of Federal Regulations (37 CFR), or to provide structural clues. These headings are not intended to limit or characterize any invention described in any claim that may be issued from this disclosure. Specifically, the description of the technology in the “Background Art” should not be construed as an acknowledgment that the technology is prior art to any invention in this disclosure. Furthermore, even if the “Invention” is referred to in the singular form in this disclosure, such reference should not be used to assert that there is only one point of novelty in this disclosure. Multiple inventions may be described in accordance with the limitations of multiple claims arising from this disclosure, and such claims define the inventions and their equivalents that are protected by such claims. In all cases, the scope of such claims should be considered on a substantive basis in light of this disclosure and should not be limited by the headings in this specification. This disclosure incorporates the entire disclosure in U.S. Provisional Application No. 63 / 507,067, filed on 8 June 2023.

[0028] This disclosure relates in several respects to a bone transport system for use in orthopedic surgery. In one application, the treatment of a foot ulcer can be performed by using a bone transport system to perform a lateral tibial bone transport to stimulate cell proliferation and angiogenesis, increase blood flow, and improve the healing of the foot ulcer. The bone transport system can allow a physician to measure and incise a portion of bone and move that portion of bone laterally relative to the surrounding bone (i.e., the main body) to stimulate blood flow. The bone transport system may be used to form a portion of bone and connect to a portion of bone, allowing that portion of the bone to be moved approximately laterally from the axis of the bone during treatment. This portion of bone may be called a bone transport segment or transport segment. The bone surrounding the transport segment may be called the main body of the bone. Moving the transport segment can promote the healing of foot ulcers of the limbs by stimulating cell proliferation and increasing blood flow to the leg.

[0029] The bone transport system includes a template 100 (see, for example, Figures 1A to 1D), a distractor 200 (see, for example, Figures 2A to 2D), one or more anchors such as half pins 400 (see, for example, Figures 5J to 5Q), one or more guide wires 190 (see, for example, Figures 5D and 5G to 5J), and guide pins or wires 192 (see, for example, Figures 5A to 5D).

[0030] Figures 1A to 1D show examples of template 100 according to several embodiments of the present disclosure. Figure 1A is an exploded perspective top view of the template. Figure 1B is a side view of the assembled template 100, excluding the wire sleeve 108, and Figure 1C is a perspective top view of the assembled template. Figure 1D is a perspective bottom view of the plate 104 of template 100. Template 100 includes the plate 104, an anchor or half-pin sleeve guide 106, and a wire sleeve guide 108. In some embodiments, template 100 may further include a stopper or cap (not shown). Template 100 can be placed on the patient's skin above a portion of bone selected by the physician as the transport segment 50 (see Figures 5B, 5P, 5Q, and 6A and 6B). The template 100 can then be used to measure, draw, define, or mark the skin flap above the transport segment 50. The skin flap allows the physician to access the bone and form the transport segment 50. The template 100 may be placed directly on the selected transport segment 50, or it may be used to measure, draw, or define the bone transport segment 50 so that the bone transport segment 50 can be moved to stimulate blood flow to the limb.

[0031] The template 100 includes a plate 104. The plate 104 functions to guide bone fixation devices or anchors, such as half pins 400, wires, anchors, screws, cables, or any other suitable bone fixation devices. Furthermore, with the help of such fixation devices, the plate 104 fixes the template 100 to the bone and maintains its position on the bone during drilling operations. The plate 104 may have a top surface 122, a bottom surface 124, two ends 126, and two sides 128 positioned between the top surface 122 and the bottom surface 124 and between the two ends 126. The plate 104 may include two openings 130 extending through the plate 104. The openings 130 may be substantially circular. In other embodiments, the opening 130 may be any suitable shape, including, for example, oblong, rectangular, square, ovate, egg-shaped, elliptical, or ovoid. One or more extensions 132 may be present around the opening 130 to provide additional support for the sleeves 106, 108 or the guide wires 190 or half pins 400 placed therein (half pins 400 (see, e.g., Figures 5J-5Q) and one or more guide wires 190 (see, e.g., Figures 5G-5J) are not shown). Furthermore, the plate 104 may include a channel 134 extending from the opening 130 to one side 128 of the plate 104. In some cases, the width 138 of the channel 134 may be smaller than the width or diameter 136 of the opening 130.

[0032] The half-pin sleeve 106 may be sized and shaped to fit the opening 130 of the plate 104. The half-pin sleeve 106 may generally be cylindrical, but can have any shape. In other embodiments, the half-pin sleeve 106 may be any suitable shape, including, for example, a square, triangle, rectangle, polygon, or irregular shape. The half-pin sleeve 106 may be hollow from top to bottom, so as to form an opening 144, through which a half-pin 400 (see, for example, Figures 5J to 5Q) may be inserted. The width or diameter 146 of the half-pin sleeve 106 may be sized to fit the opening 130 of the plate 104 (i.e., the diameter 146 of the half-pin sleeve 106 may be slightly smaller than the diameter 136 of the opening 130 of the plate 104). The diameter 146 of the half-pin sleeve 106 may be larger than the width 138 of the channel 134 so that the half-pin sleeve 106 cannot move through the channel 134 from the opening 130.

[0033] In some embodiments, the opening 130 of the plate 104 may have threads 148, and the bottom of the half-pin sleeve 106 may have threads 149. Thus, the threads 149 on the half-pin sleeve 106 can be configured to engage with the threads 149 on the opening 130 of the plate 104, allowing insertion of the half-pin sleeve 106. In the illustrated embodiment, the half-pin sleeve 106 includes male threads 149, and the opening 130 of the plate 104 includes female threads 148. However, in other embodiments, this may be reversed. Furthermore, other embodiments may use any suitable coupling mechanism that allows the half-pin sleeve 106 to be removed along the axis of the opening 130 of the plate 104. For example, the half-pin sleeve 106 may snap into the opening 130 of the plate 104, or it may form a friction fit with the opening 130 of the plate 104, or the half-pin sleeve 106 may be coupled to the opening 130 by twisting using a quarter-turn technique.

[0034] In some embodiments, the outer surface of the half-pin sleeve 106 above the thread 149 may include a plurality of flat surfaces 145. The flat surfaces 145 can facilitate the physician's gripping and manipulation of the half-pin sleeve 106. However, any suitable gripping mechanism may be used on the half-pin sleeve 106. For example, the half-pin sleeve 106 may include a raised portion, a tab or handle, or a more flexible or pliable material to improve the gripping of the half-pin sleeve 106.

[0035] The wire sleeve 108 may be sized and shaped to fit the opening 144 of the half-pin sleeve 106. The wire sleeve 108 may be substantially cylindrical. In other embodiments, the wire sleeve 108 may be any suitable shape, including, for example, a square, triangle, rectangle, polygon, or irregular shape. Each wire sleeve 108 may be hollow from top to bottom, thus forming an opening 150. The opening 150 of the wire sleeve 108 may be shaped so that a guide wire 190 (see, for example, Figures 5G to 5J) fits through the opening 150. The opening 150 may have any shape that substantially matches the cross-section of the guide wire 190, such as a circle, cylinder, square, rectangle, polygon, or irregular shape.

[0036] Each wire sleeve 108 includes a head 152 that extends upward and outward from the shaft 154 of the wire 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. This gives the head 152 a hemispherical shape. The head 152 of the wire sleeve 108 is generally smooth so that the wire sleeve 108 does not irritate the skin that comes into contact with the head 152.

[0037] Plates 102 and 104 may include guide pin openings 194 shaped to accommodate guide pins or wires 192 (see, for example, Figures 5A to 5D). The guide pins 192 may be configured to attach the template 100 to the bone before insertion of the guide wire 190 (see, for example, Figures 5B and 5C), as will be described in more detail below.

[0038] As shown in Figure 1B, in some cases the openings 130 and extensions 132 of the plate 104 may be inclined outward toward the end 126 of the plate 104. The left opening 130 (and the corresponding half-pin sleeve 106) in Figure 1B is oriented at an angle α1 with respect to the vertical. The right opening 130' (and the corresponding half-pin sleeve 106') in Figure 1B is oriented at an angle α2 with respect to the vertical. This ultimately guides the half-pin 400 (not shown) at an angle α1 for the pin 400 and at an angle α2 for the pin 400' during insertion, resulting in the tips of the half-pins 400 and 400' converging within the transport segment 50.

[0039] The angles α1 and α2 may be any appropriate value. For example, α1 and α2 may be any angle within the range of 0 to 80 degrees. In some embodiments, α1 or α2 may be plus or minus 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, or 80 degrees. In some embodiments, the openings 130, 130' may be at an angle of 15 degrees with respect to the vertical. In some cases, the openings 130, 130' may be at different angles with respect to the bone surface. Although the openings 130, 130' are shown to be inclined inward toward each other, the openings 130, 130' may be inclined outward toward each other, or they may be inclined in the same direction.

[0040] Therefore, when the half-pin sleeve 106 and wire sleeve 108 are inserted into the opening 130, the sleeves 106 and 108 also tilt outward toward the end 126 of the plate 104, such that the sleeves 106 and 108 tilt toward the upper surface 122 of the lower plate 204. This allows the half-pins 400 (see, for example, Figures 5K to 6A) to be inserted into the transport segment 50 such that they tilt outward toward the end 126 of the plate 104 and inward toward each other so as to converge within the transport segment 50. This inclination of the half-pins 400 toward each other provides further stability and improves the movement of the transport segment 50 (see, for example, Figures 5K to 6A), as will be described in more detail below.

[0041] In some embodiments, the template 100 (or wire 190) may include a cap, bead, or stopper (not shown). The stopper may be fixed to the wire or positioned on the guide wire 190 such that its bottom contacts the top of the wire sleeves 107, 108 when the guide wire 190 is inserted through the wire sleeves 107, 108. Thus, the stopper functions as a depth stopper to limit the penetration of the wire into the bone. The guide wire 190 can then be cut above the stopper. Thus, the stopper can be used as a guide for cutting the guide wire 190. The stopper may be rounded so that the guide wire 190 does not come into contact with the skin flap when the skin flap is pulled over the stopper, thereby cutting or damaging the skin flap. In some embodiments, the stopper may have a pointed conical top or a rounded conical top, or it may have a rounded or smooth shape such as spherical, annular, elliptical, conical, or oblate. Thus, in some cases, the stopper may be configured to provide smooth contact with the skin above the wire sleeves 107, 108.

[0042] In some embodiments, the plate 104 may include a tab 140 on its posterior side 128 to facilitate handling of the template 100 during positioning on the skin and subsequently on the bone surface. The tab 140 may include grooves, rubber, or other features to improve the physician's grip on the plate 104. As shown in Figures 1A and 1D, the tab 140 may include a recess 143 at its base. This recess 143 may allow the physician to more easily grasp the tab 140 and thus more easily manipulate the template 100 using the physician's hand or instruments (e.g., forceps) (not shown).

[0043] In some embodiments, the plate 104 does not have to have two openings 130. The plate 104 can have any suitable number of openings 130, such as one, three, four, or five openings 130. In some embodiments, the template 100 can have elongated guide openings or multiple holes that form cutting guide slots to guide bone cutting. For example, cutting guide slots can guide a blade cutting instrument, and multiple holes can guide a drill bit. The plate 104 may be formed of any suitable material, including metal, plastic, or a combination thereof.

[0044] In some embodiments, the template 100 may further include a drill guide or sleeve 160. Figure 1E shows a drill sleeve 160 according to one or more embodiments of the present disclosure. Similar to the wire guide 108, the drill sleeve 160 may be sized and shaped to fit the opening 144 of the half-pin sleeve 106. The drill sleeve 160 may be substantially cylindrical. In other embodiments, the drill sleeve 160 may be any suitable shape, including, for example, a square, triangle, rectangle, polygon, or irregular shape. The drill sleeve 160 may be hollow from top to bottom, thus forming an opening 170. The opening 170 of the drill sleeve 160 may be shaped to fit and allow a drill bit to pass through, as will be described in more detail below.

[0045] The drill sleeve 160 may include a head 162 extending upward and outward from the shaft 164. In some embodiments, the upper part 166 of the head 162 is generally flat and has an outer side surface 168 extending downward therefrom. Thus, the head 162 of the drill sleeve 160 can form a cylindrical shape.

[0046] Figures 2A to 2D show examples of a distractor 200 according to several embodiments of the present disclosure. Figure 2A is a perspective front view of the distractor 200, Figure 2B is a top view, Figure 2C is a perspective rear view, and Figure 2D is an exploded view.

[0047] Once a half-pin 400 (see, for example, Figures 5J-5Q) is inserted into the transport segment 50 (see, for example, Figures 5B and 5P-5Q) and a hole is drilled around at least a portion of the transport segment 50, a distractor 200 can be attached to the half-pin 400, as will be described in more detail below, and an additional half-pin 400' (see, for example, Figures 5O-5Q) can be inserted into the main body portion 52 of the bone adjacent to the transport segment 50 and attached to the distractor 200. The distractor 200 can move the transport segment 50 laterally or laterally with respect to the axial direction of the bone to stimulate blood flow to the limb.

[0048] The distractor 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 have half-pin holders 208 positioned at each of their respective ends 210, 212. The length 203 of the upper beam 202 may be shorter than the length 205 of the lower beam 204. Thus, the half-pin holders 208 of the upper beam 202 can be displaced longitudinally relative to the half-pin holders 208 of the lower beam 204. Consequently, the half-pin holders 208 of the upper beam 202 are located closer to the center of the distractor 200, while the half-pin holders 208 of the lower beam 202 are located further from the center of the distractor 200.

[0049] The upper and lower beams 202, 204 may have openings 236 near their ends 210, 212. Each opening 236 may have a rounded or partially spherical inner surface (not shown) and a rounded or partially spherical outer surface 240. In some embodiments, the outer surface 240 may coincide with the contour of the inner surface, while in other embodiments, the outer surface 240 may be cylindrical and the inner surface may be spherical to engage with a spherical nut 220.

[0050] The openings 236 may be elongated vertically or slot-shaped. Three of the openings 236 may be oriented generally vertically (but slightly inclined with respect to the vertical). Each of these three openings may have the same angle. However, the fourth opening 236' located on the upper beam 202 may be inclined with respect to the vertical and also inclined with respect to the other openings 236. For example, the fourth opening 236' may be inclined outward from the center at an angle in the range of 0 to 90 degrees. This allows for greater flexibility of the distractor 200 when attaching the half pins 400 to the half pin holder 208.

[0051] Three half-pin holders 208 may be positioned in the three openings 236. The half-pin holders 208 may include a clamp having an outer portion 214 movably coupled to an inner portion 216. The half-pin holders 208 may include threaded extensions 218 extending through the openings 236 of the beams 202, 204. A nut 220 can be screwed onto the threaded extension 218. The nut 220 may include a head 242 and a base 244. The head 242 may be hexagonal. In other embodiments, the head 242 may be of a different shape, such as a square, pentagon, circle, or any other shape. The base 244 may be rounded, such as partially spherical or hemispherical. A rounded base 244 may be shaped so that the nut 220 can pivot, rotate, or move along the inner surface 238 of the opening 236. The inner portion 216 of the clamp may have a flat or rounded bottom surface which may be shaped to pivot, slide, rotate, or move along the rounded outer surface 240 of the opening 236. In some embodiments, the bottom surface of the inner portion 216 may have grooves or be roughened to increase friction between the inner portion 216 and the outer surface 240 of the opening 236.

[0052] In some embodiments, three of the half-pin holders 208 include a nut 220 having a rounded base 244. However, a fourth half-pin holder 208' may include a nut 220' having a similar hexagonal head 242' and a relatively cylindrical base 244'. The cylindrical base 244' may be smaller than the rounded base 244 of the other three half-pin holders 208. The fourth half-pin holder 208' may include the same clamp (having the same outer portion 214 and inner portion 216) and the same threaded extension 218. This fourth half-pin holder 208' may be configured to be inserted into a fourth opening 236' such that the fourth half-pin holder 208' has a larger range of motion than the other three half-pin holders 208.

[0053] In some embodiments, the fourth opening 236' can allow the fourth half-pin holder 208' to move laterally or obliquely relative to the beam 202, while also allowing the half-pin holder 208' to pivot or rotate. Thus, the half-pin 400 positioned in the fourth half-pin holder 208' can have an additional axis of movement. Conveniently, the different half-pin axes allow the fourth opening 236' to work in conjunction with the fourth half-pin holder 208' to adjust the distance of the distractor 200 from the bone while continuing to accept the same pin angle. For example, if the patient's skin is thicker, or if there is a large amount of fat, muscle, or other soft tissue between the skin and bone, the fourth half-pin holder 208' can be slid outward along the fourth opening 236' so that the distractor 200 can be moved further away from the bone. The distance between the distractor 200 and the bone may be adjusted so that the distractor 200 is in contact with the skin, or so that there is a gap between the distractor 200 and the skin. Therefore, the distractor 200 can be used in a wide variety of patients, where the amount of soft tissue around the tibia may vary.

[0054] For all half-pin holders 208, 208', when the nut 220 is loosened, the outer portion 214 of the clamp may be configured to move outward from the beams 202, 204, allowing the half-pin holders 208, 208' to pivot, swivel, or otherwise rotate. Furthermore, the half-pin holders 208, 208' may be able to slide or move up and down within the openings 236, 236'. The outer portion 214 may have one or more grooves or channels that fit the half-pin 400. Thus, the half-pin holders 208, 208' may be able to move to accommodate any angular position of the half-pin 400, such as along an axis parallel to the beams 202, 204 (i.e., a horizontal axis) or an axis perpendicular to the beams 202, 204 (i.e., a vertical axis).

[0055] As the nuts 220, 220' are moved to tighten the clamp, the outer portion 214 contacts the inner portion 216 and is pulled relative to the inner portion 216, holding or securing the half pin 400 to the beams 202, 204. When tightened, the clamp can fix the angular position of the half pin 400 and thus prevent movement or rotation of the outer portion 214 or the half pin 400 relative to the beams 202, 204. In some embodiments, the half pin holders 208, 208' may rotate through a plurality of discrete angular positions or may rotate through all angular positions continuously. The inner surface of the outer portion 214 and the outer surface of the inner portion 216 may have grooves that can connect to each other so that the half pin holders 208, 208' can correspond to discrete angular positions and / or prevent movement of portions 214, 216 when the clamp is tightened. As described above, the fourth half-pin holder 208' may have a larger range of motion than the other three half-pin holders 208, and therefore may be able to rotate over a larger angular range than the other three half-pin holders 208.

[0056] While specific embodiments of the half-pin holders 208, 208' are described herein, any suitable movable holders 208, 208' configured to accommodate multiple angular positions of the half-pin 400 can be used herein. For example, one or more half-pin holders 208, 208' may be ball socket connectors or hinged clamps, or they may be screws or bolts, as will be described in more detail below.

[0057] The half-pin holders 208, 208' of the upper beam 202 may be positioned to connect to half-pins 400 inserted into the bone transport segment 50 using a template 100, as will be described in more detail below. The half-pin holder 208 of the lower beam 204 may be configured to attach to half-pins 400' inserted into the bone body portion 52 adjacent to the transport segment 50.

[0058] The actuator 206 may include a knob 222 and a threaded rod 224. Each of the beams 202, 204 may include a block 226 having an opening 227 that fits the threaded rod 224. Each block 226 may be coupled to the center of the beams 202, 204. The knob 222 may be coupled to one end of the threaded rod 224. The knob 222 may be positioned on top of a block 226 coupled to the upper beam 202 so that the threaded rod 224 extends through the openings 227 of both blocks 226. Support columns 228 may be present, extending from the opening 229 of one block 226 to the opening 229 of the other block 226. The support columns 228 may be positioned on both sides of the threaded rod 224 and may be positioned near or in the vicinity of the threaded rod 224 to provide support and prevent the upper beam 202 from rotating relative to the lower beam 204.

[0059] In some embodiments, the threaded rod 224 may be fixedly mounted to at least one of the openings 227 of the block 226. The threaded rod 224 can be screwed onto the knob 222. By rotating the knob 222, the threaded rod 224 can be moved up and down within the opening of the knob 222. The knob 222 can be rotated in a first direction to move the threaded rod 224 downward, and in a second opposite direction to move the threaded rod 224 upward. Thus, by rotating the knob 222 in the first direction, the upper beam 202 and the lower beam 204 can be brought closer together. By rotating the knob 222 in the second direction, the upper beam 202 and the lower beam 204 can be moved further apart. The support column 228 can be movably coupled to at least one block 226 (e.g., the lower beam 204) to allow the beams 202 and 204 to move relative to each other.

[0060] In other embodiments, the openings 227 in the block 226 on the lower beam 204 and / or the block 226 on the upper beam 202 may have threads to screw with the threaded rod 224. The knob 222 can be rotated to move the threaded rod 224 through the openings 227 in the block 226. The knob 222 can be rotated in a first direction to move the threaded rod 224 downward, and in a second opposite direction to move the threaded rod 224 upward. Thus, the upper beam 202 and the lower beam 204 can be brought closer together by rotating the knob 222 in the first direction. The upper beam 202 and the lower beam 204 can be moved further apart by rotating the knob 222 in the second direction. To allow the beams 202 and 204 to move relative to each other, a support column 228 can be movably coupled to one of the blocks 226. In other embodiments, there is no block 226 coupled to the upper beam 202 or the lower beam 204.

[0061] The knob 222 may be capable of rotating through a plurality of discrete rotational positions. For example, the knob 222 may be configured to move in quarter-turn increments by providing projections (not shown) on the underside of the knob 222 that fit into recesses (not shown) of the block 226 at 90-degree intervals. The knob 222 may include a sleeve adapter 235, which has an opening 237 extending from the top to the bottom of the sleeve adapter 235. The opening 237 may be configured to fit a threaded rod 224. A spring 234 may be placed between the knob 222 and the sleeve adapter 235 to bias the projection toward the recess. In this way, each time the knob 222 is rotated, the threaded rod 224 moves by a predetermined amount. For example, each time the knob 222 rotates by a quarter turn, the threaded rod 224 can move up or down by 0.25 millimeters (mm). In other examples, with each full or partial rotation of the knob, the screw rod can move by 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 mm. The amount of movement of the screw rod 224 may correspond to the amount of movement of the transport segment 50.

[0062] In other embodiments, the knob 222 may be able to move through any rotational position in a continuous manner. In some cases, the distractor 200 may be able to move the transport segment 50 in a progressive or discrete amount from a pull of 0 mm to a pull of 20 mm and back to a pull of 0 mm.

[0063] Figures 3A to 3F show one embodiment of the T-shaped drill guide 500 according to one or more embodiments of the present disclosure. For the T-shaped drill guide 500, Figure 3A is a perspective front view, Figure 3B is a perspective side view, and Figure 3C is a perspective bottom view. Figure 3D is a perspective side view with a drill bit 384 inserted, and Figure 3E is a perspective bottom view of the T-shaped drill guide 500 in use to drill a hole around the corner of the plate 104 of the template 100. Figure 3F is a perspective side view of the T-shaped drill guide 500 with a drill bit 384 inserted in use to drill a hole around the side 128 of the plate 104 of the template 100. After the template 100 is placed on the bone, a T-shaped drill guide 500 can be used to drill holes around the bone transport segment 50 (as shown in Figures 5E and 5F) and to remove the half-pin sleeve 106 from the plate 104 around the half-pin 400 (as shown in Figure 5L).

[0064] The T-shaped 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 may form the base of the T, and the drill bit guide shaft 504 may form the upper or lateral portion of the T. The half-pin drill guide shaft 502 includes an opening 506 extending from a lower end 508 to an upper end 510. The bottom 507 of the opening 506 may be hexagonal (but may be any shape), for example, similar to a socket tool for tightening bolts. The bottom 507 of the opening 506 of the half-pin drill guide shaft 502 may be configured to fit and cover the hexagonal portion 145 of the half-pin sleeve 106. Thus, the half-pin drill guide shaft 502 may be configured to loosen / remove the threads 149 of the half-pin sleeve 106 from the threads 148 of 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, for example, Figure 5L) which has already been inserted into the bone through the opening 144 of the half-pin sleeve 106 (see, for example, Figures 5J to 5K). In some cases, the remaining portion of the opening 506 may be cylindrical.

[0065] In other embodiments, the opening 506 may be hexagonal in shape. In yet another embodiment, the opening 506 may be cylindrical in shape.

[0066] The drill bit guide shaft 504 can be coupled to the upper end 510 of the half-pin drill guide shaft 502, such that the opening 506 remains accessible through the upper end 510. The drill bit guide shaft 504 may have two ends, namely a first corner drilling end 512 and a second lateral drilling end 514. The perimeter drill guide shaft 504 may have an opening 520 extending from the corner drilling end 512 to the lateral drilling end 514.

[0067] The corner drilling end 512 may be configured to contact the corner 123 of the plate 104. For example, the corner drilling end 512 may include an alignment structure that includes a projection 516 extending upward from the base surface 517. The projection 516 may be cross-shaped or a plus sign shape so that the corner 123 of the plate 104 fits into the corner 518 of the projection 516. Thus, the projection 516 may have a first wall and a second wall configured to contact the side surface 128 and the end 126 of the plate 104 on both sides of the corner 123, respectively. The base surface 517 of the corner drilling end 512 may contact, abut, and / or press against the top surface 122 of the plate 104. The opening 520 of the drill bit guide 504 may extend through the center of the projection 516.

[0068] The lateral drilling end 514 may be configured to contact a side surface 128 or end 126 of the plate 104. For example, the lateral drilling end 514 may include an alignment structure that includes a projection 522 extending upward from the base surface 526. The projection 522 may be linear (for example, it may include a wall) so that the side surface 128 or end 126 of the plate 104 contacts the side surface 524 of the projection 522. The base surface 526 of the lateral drilling end 514 may contact, abut, and / or press against the top surface 122 of the plate 104. The opening 520 of the drill bit guide 504 may extend through the center of the projection 522.

[0069] For both ends 512, 514 of the drill bit guide 504, the base surfaces 517, 526 are inclined with respect to the longitudinal axis of the drill bit guide 504. In some embodiments, the base surfaces 517, 526 are not perpendicular or parallel to the longitudinal axis, and therefore each of the base surfaces 517, 526 is inclined at an angle between 0 and 90 degrees with respect to the longitudinal axis. The base surfaces 517, 526 may be inclined such that when one of the ends 512, 514 is positioned around the plate 104, the opening 520 of the drill bit guide 504 is inclined toward the plate 104.

[0070] As shown in Figure 3D, when the corner drilling end 512 of the perimeter drill guide shaft 504 is positioned at the corner 123 of the plate 104, the longitudinal axis of the perimeter drill guide shaft 504 is inclined with respect to the upper surface 122 of the plate 104. Similarly, as shown in Figure 3F, when the lateral drilling end 514 of the perimeter drill guide shaft 504 is positioned at the side surface 128 or end 126 of the plate 104, the longitudinal axis of the perimeter drill guide shaft 504 is also inclined with respect to the upper surface 122 of the plate 104.

[0071] Therefore, the drill bit guide 504 guides the drill bit 384 to drill a hole in the bone that is inclined inward toward the plate 104. This causes the transport segment 50 of the bone to incline inward from top to bottom, as will be described in more detail below with reference to Figure 6B, and prevents the transport segment 50 from falling into the main body portion 52 of the bone.

[0072] In other embodiments, the projections 516, 522 of the ends 512, 514 of the perimeter drill guide shaft 504 may be of any suitable shape. In some embodiments, one end of the perimeter drill guide shaft 504 may have a T-shaped projection that can be positioned around both the corner 123 and the side 128 and end 126 of the plate 104.

[0073] Figure 4 is a flowchart illustrating an example of a method 300 for performing bone transport using a bone transport system according to several embodiments of the present disclosure. Method 300 will be described with reference to Figures 5A to 5Q. Steps 302 to 330 of Method 300 will be described and illustrated with reference to Figures 5A to 5Q, which show various components of the system applied to the patient's body structure.

[0074] Any suitable template can be used in accordance with Method 300. For example, embodiments of template 100 shown in Figures 1A to 1E are shown in Figures 5A to 5Q. However, any of the templates shown in Figures 7A and 7B or Figures 10A to 10L (described in further detail below) can be used in the same manner as in Method 300.

[0075] Step 302 of method 300 shown in Figure 4 may include placing a plate 104 of template 100 on the skin above a desired transport segment 50 of bone. The physician may select a desired transport segment 50 based on the anatomical structure of the bone, the condition of the surrounding soft tissue, the level of maintenance of blood supply to the limb, the ease of access to the bone transport system, or any other appropriate factor. For example, plate 104 may be placed on the medullary canal process on the medial surface of the tibia. The level and orientation of the plate can be confirmed using digital C-arm fluoroscopy or static digital radiography.

[0076] Step 303 of method 300 shown in Figure 4 may include inserting a first guidewire 192 through the guide pin opening 194 of the plate 104 of the template 100, through the skin, and into the bone, penetrating both cortices. The first guidewire 192 may be extended through the skin, subcutaneous soft tissue, and both cortices of the bone to stabilize the level of the template 100 and to keep the first guidewire 192 as perpendicular as possible to the bone. The first guidewire 192 may be inserted into a desired transport segment 50 of the bone.

[0077] Step 304 of method 300 shown in Figure 4 may include incising the skin and approaching the area of ​​the transport segment 50. After inserting the first guidewire 192, the physician may mark the skin around the plate 104 of the template 100. Using the plate 104 as a guide, the physician may mark the skin using a marker or any other suitable instrument. The skin may be marked around part or all of the upper plate 102. For example, the physician may mark only three sides around the template 100 to draw the skin flap. In some embodiments, the physician may mark only one or two sides around the upper plate 102, or all four sides. In particular, the posterior edge 380 around the plate 104 may be marked. Furthermore, the skin may be marked through the opening 130 of the plate 104. These markings can draw the exit hole 382 in the skin flap. Next, the skin can be incised along the markings to create a skin flap (cut at least along the posterior side 380), an exit hole 832, and a guidewire opening around the first guidewire 192. The first guidewire 192 may be cut along the upper surface 110 of the plate 104 so that the end of the first guidewire 192 is coplanar with the upper surface 122. Once the skin flap and opening are cut, the plate 104 of the template 100 can be removed. The plate 104 may be removed from the skin upward over the first guidewire 192. Figure 5A shows the bone and skin (shown as transparent with a dotted line) with the template 100 removed (and therefore not shown) and the first guidewire 192 inserted. The cut along the markings made using the template 100 draws a flap including the posterior side 380 and draws an exit hole 382, ​​as shown by the dotted line in Figure 5A.

[0078] Once the incision is made, the skin flap can be retracted to expose the bone of the transport segment 50. The physician may incise the skin and subcutaneous soft tissue from the skin to the bone. In some embodiments, the physician may make an incision along part or all of the surrounding markings to form a skin flap. In particular, the physician may make an incision along the posterior edge 380 around the midplane of the tibia. This incision may be about 10 centimeters (cm). The surrounding edges adjacent to the posterior side may be similarly incised. In some embodiments, these incisions may be about 5 mm.

[0079] Furthermore, the physician may further cut the exit holes 382 so that they extend through the skin flap. These exit holes 382 may be sized and shaped to fit and overlap the half-pin sleeve 106 and wire sleeve 108, as will be described in more detail below with reference to step 311 (see, for example, Figure 5C). The skin flap can then be retracted or removed from the bone to expose the transport segment 50. In some embodiments, the physician may make the incision of the marked exit hole 382 by piercing the skin. The physician may pull up the skin on the first guidewire 192 to open the skin incision and expose the transport segment 50.

[0080] Step 305 of method 300 shown in Figure 4 may include repositioning the template 100 on the first guidewire 192 by the guide pin opening 194 with the skin retracted. Step 306 may be shown in Figures 5B and 5C. Figure 5B is a top perspective view and Figure 5C is a side perspective view of the template 100 positioned on the first guidewire 192 so as to be positioned on the transport segment 50. The first guidewire 192 may be inserted into the guide pin opening 194 of the plate 104 to position the plate 104 in the center on the transport segment 50. The physician may adjust the plate 104 to properly align it on the transport segment 50. The physician may position the plate 104 so that the channel 134 of the plate 104 faces the anterior side of the periphery (for example, toward the retracted skin flap). The half-pin sleeve 106 can be placed in the opening 130 of the plate 104, and the wire sleeve 108 can be placed in the half-pin sleeve 106. The wire 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 and 108 may be assembled after the plate 104 is placed on the transport segment 50.

[0081] Step 306 of method 300 shown in Figure 4 may include inserting second and third guidewires 190 through the opening 150 of the wire sleeve 108 of the template 100 into the bone, penetrating both cortices. Step 306 is shown in Figure 5D (skin and subcutaneous tissue are not shown). The second and third guidewires 190 may be inserted by any suitable means, such as perforation or tapping the ends of the guidewires 190. In some embodiments, the guidewires 190 may be inserted so as to extend through the entire width of the bone, extending through both cortical layers of the bone and the medullary cavity between them. As shown in Figure 5D, the guidewires 190 may be cut or trimmed along the upper part 156 of the head 152 of the wire sleeve 108. The guidewires 190 may be cut such that the ends of the wire 190 are coplanar with the upper part 156 of the head 152 of the wire sleeve 108 and therefore do not protrude above the head 152. Therefore, the wire 190 may be relatively smooth along the upper part 156 of the wire sleeve 108. By cutting the guide wire 190, the system can be made easier to handle and it is possible to prevent the guide wire from scratching, cutting, irritating, or otherwise damaging the skin or soft tissue.

[0082] As described in more detail above, the opening 130 of plate 104 (and thus the half-pin sleeve 106 and wire sleeve 108) is inclined with respect to the upper surface 122 of plate 104. Therefore, the wire 190 is inserted so as to be inclined inward into the transport segment 50.

[0083] Step 308 of Method 300 may include drilling holes in the projection of the transport segment 50 using a T-shaped drill guide 500 around the template 100. First, the physician can drill holes around each corner 123 of the plate 104 using the corner drilling end 512 of the periphery drill guide shaft 504 of the T-shaped drill guide 500, as shown in Figure 5E (skin and subcutaneous tissue not shown). The corner drilling end 512 can be positioned such that the corners 518 of the cruciate projection 516 contact the corners 123 of the plate 104 and the base surface 517 contact the top surface 122 of the plate 104. The drill bit 384 can then be inserted into the bone through the opening 520 of the periphery drill guide shaft 504 to drill a hole in the bone. As described above, the periphery drill guide shaft 504 can tilt the drill bit 384 to an angle such that the hole drilled in the bone is inclined inward toward the transport segment 50.

[0084] Next, the physician can use the lateral drilling end 514 of the periphery drill guide shaft 504 of the T-shaped drill guide 500 to drill holes around the sides 128 and end 126 of the plate 104, as shown in Figure 5F (skin and subcutaneous tissue are not shown). The lateral drilling end 514 can be positioned so that the side 524 of the linear projection 522 contacts the side 128 (or end 126) of the plate 104 and the base surface 526 contacts the top surface 122 of the plate 104. The drill bit 384 can then be inserted into the bone through the opening 520 of the periphery drill guide shaft 504 to drill a hole in the bone. Similarly, the periphery drill guide shaft 504 can be tilted so that the drill bit 384 is angled such that the hole drilled in the bone inclines inward toward the transport segment 50, as described above.

[0085] During this process, the physician can use the half-pin drill guide shaft 502 of the T-shaped drill guide 500 as a handle to hold and manipulate the periphery drill guide shaft 504.

[0086] The holes may be drilled along the entire circumference of the plate 104. In some embodiments, 4 to 20 holes can be drilled around the transport segment 50. For example, the holes may be drilled along the four corners 123 of the plate 104, and along the sides 128 and ends 126 between the corners 123.

[0087] Step 310 of Method 300 may include cutting at least a portion of the bone between a plurality of perforations drilled around the transport segment 50, as shown in Figure 5G (Figure 5G also shows step 311, as described below). The bone may be cut between the perforations for cutting around at least a portion of the transport segment 50. The bone may be cut using any suitable method, such as manually cutting the bone between the perforations with a bone knife or using a powered device such as a drill or bone saw. In some cases, only the uppermost layer of cortical bone may be cut. In other embodiments, some or all of the bone marrow in the medullary cavity may be cut. In preferred embodiments, it is not necessary to cut all sides of the transport segment 50. In some embodiments, three, two, or one side may be cut. For example, in the embodiment shown in Figure 5G, the posterior side of the transport segment 50 may not be cut.

[0088] Step 311 of method 300 shown in Figure 4 may include repositioning the skin 60 by covering the template 100 and wire sleeve 108. Figure 5G may also show the skin flap 62 repositioned by covering the template 100 and wire sleeve 108 according to step 311. After incising between holes along the periphery of the transport segment 50, the skin flap can be repositioned to cover the transport segment 50. The skin flap 62 may be pulled over the plate 104. The half-pin sleeve 106, in which the wire sleeve 108 and the cut guide wire 190 are positioned, can be inserted through the corresponding exit hole 382 of the skin flap 62 such that the complex protrudes through the top of the skin flap 62 and extends past the top of the skin flap 62. Thus, the bottom of the skin flap 62, which may have subcutaneous soft tissue, may be positioned directly above and in contact with the plate 104, the half-pin guide 106, and / or the wire guide 108. The tabs 140 of the plate 104 may protrude from the posterior side 380 around the skin flap 62. As shown in Figure 5G, the exit hole 382 is defined by two walls of skin extending from the top to the bottom of the skin flap 62. Similarly, the opening may be located in a posterior incision 380 between the posterior side of the skin flap 62 and the main body portion 61 of skin adjacent to the posterior side of the skin flap 62. The opening may extend from the top to the bottom of the skin. The plate 104 of the template 100 may be removed from the patient through the opening in the posterior incision 380, as will be described in more detail below with reference to step 324.

[0089] Step 312 of method 300 shown in Figure 4 may include removing the second guidewire 190 and the corresponding wire sleeve 108. Step 312 is shown in Figure 5H (skin and subcutaneous tissue are not shown). The guidewire 190 and wire sleeve 108 can be removed roughly laterally or obliquely with respect to the axial direction of the bone. Figure 5H shows the template 100 after the second guidewire 190 and the corresponding wire sleeve 108 have been removed from the pin sleeve 106 (skin and subcutaneous tissue are not shown).

[0090] Step 314 of method 300 shown in Figure 4 may include inserting a drill sleeve 160 into a half-pin sleeve 106 and drilling a hole in the transport segment 50. Step 314 is shown in Figure 5I (skin and subcutaneous tissue are not shown). The shaft 164 of the drill sleeve 160 can be inserted into the opening 144 of the half-pin sleeve 106 such that the head 152 of the drill sleeve 160 contacts the top of the half-pin sleeve 106. The drill bit 384 can then be inserted through the drill sleeve 160 into the transport segment 50 of the bone to drill a hole in the transport segment 50.

[0091] Step 316 of method 300 shown in Figure 4 may include inserting the half pin 400 into the transport segment 50 through the half pin sleeve 106. Step 316 is shown in Figure 5J. The half pin 400 can be inserted using any suitable method, such as screwing or hammering. The half pin 400 can be inserted through the half pin sleeve 106 such that the half pin 400 is inserted into the transport segment 50 at an angle to the upper surface 122 of the plate 104, and therefore at an angle to the surface of the transport segment 50.

[0092] Step 317 of method 300 shown in Figure 4 may include repeating steps 312-316 for a third guidewire 190, a corresponding wire sleeve 108, and a half pin 400. Figure 5K shows the system after step 317 has been performed (i.e., after the wire 190 and wire sleeve 108 have been removed and the half pin 400 has been inserted into the transport segment 50 through the half pin sleeve 106). Although the skin and subcutaneous tissue are not shown in Figure 5K, it should be understood that the plate 104 may be positioned beneath the skin and that the half pin sleeve 106 and half pin 400 penetrate the skin and protrude outward. In some embodiments, the half pin 400 may be tilted backward or forward, in addition to being tilted relative to the upper surface 122 of the plate 104.

[0093] Step 318 of method 300 shown in Figure 4 may include removing the half-pin sleeve 106. The half-pin sleeve 106 can be removed from the opening 130 of the plate 104 using a T-shaped drill guide 500, as shown in Figure 5L (skin and subcutaneous tissue are not shown). The half-pin drill guide shaft 502 of the T-shaped drill guide 500 can be positioned to cover the half-pin 400 and the half-pin sleeve 106 such that the bottom 507 of the opening 506 of the half-pin drill guide shaft 502 overlaps the multiple flat surfaces that form the hexagonal portion 145 of the half-pin sleeve 106. The T-shaped drill guide 500 can be rotated to loosen / disengage the threads 149 on the half-pin sleeve 106 from the threads 148 in the opening 130 of the plate 104. The T-shaped drill guide 500 can remove the half-pin sleeve 106 upward along the longitudinal axis of the half-pin 400. During this process, the physician can use the periphery drill guide shaft 504 as a handle to manipulate the half-pin sleeve 106. Figure 5M shows the system after step 318 (i.e., after the half-pin sleeve 106 has been removed).

[0094] In some embodiments, the first guide wire 192 may be removed after the half-pin sleeve 106 has been removed. However, in other embodiments, the first guide wire 192 may be removed before the half-pin sleeve 106 has been removed. The first guide wire 192 may be removed upward, approximately vertically from the top surface 122 of the plate 104 (see, for example, Figure 5K).

[0095] Step 320 of method 300 shown in Figure 4 may include attaching the distractor 200 to the half-pin 400 inserted into the transport segment 50. Step 320 is shown in Figure 5N (skin and subcutaneous tissue are not shown). Half-pin holders 208, 208' on the upper beam 202 of the distractor 200 can be positioned on the half-pin 400. The half-pin holders 208, 208' can be moved, rotated, pivoted, or swiveled to fit the inserted half-pin 400, which may be inserted at an angle to the surface of the transport segment 50. The nuts 220, 220' on the half-pin holders 208, 208' (see, for example, Figure 5O) can be tightened to secure the distractor 200 to the half-pin 400 by tightening the half-pin holders 208, 208' around the half-pin 400.

[0096] Step 322 of method 300 shown in Figure 4 may include inserting a half-pin 400' into a bone body portion 52 adjacent to the transport segment 50 and attaching the half-pin 400' to the distractor 200. Step 322 is shown in Figure 5O (skin and subcutaneous tissue are not shown). The half-pin 400' inserted into the body portion 52 may be the same as or different from the half-pin 400 inserted into the transport segment 50, as will be described in more detail below. In some embodiments, the half-pin 400' inserted into the body portion 52 may be bicortical and may penetrate both cortical layers and extend throughout the bone. Thus, the half-pin 400' inserted into the body portion 52 may be stationary relative to the half-pin 400 inserted into the transport segment 50. The half-pin holder 208 of the lower beam 204 of the distractor 200 may be positioned on the half-pin 400' inserted into the body portion 52. The half-pin holder 208 can be moved, rotated, pivoted, or swiveled to fit an inserted half-pin 400', which may be inserted at an angle to the surface of the main body portion 52. The nut 220 of the half-pin holder 208 can be tightened to secure the half-pin holder 208 around the half-pin 400', thereby fixing the distractor 200 to the half-pin 400'. The half-pin 400' may be inserted into the main body portion 52 before or after being attached to the distractor 200. The half-pin 400' can be inserted using any suitable method, such as screwing or hammering.

[0097] In some embodiments, one or more of the half-pins 400, 400' may be cut or trimmed. The physician may cut or trim the half-pins 400 to make handling of the bone transport system easier or to prevent the half-pins 400, 400' from interfering with the distractor 200 during traction and contraction.

[0098] Step 324 of method 300 shown in Figure 4 may include removing the plate 104 of the template 100. The half-pin sleeve 106 has a diameter 146 which is larger than the width 138 of the channel 134 of the plate 104, and the width 138 of the channel 134 is larger than the diameter 408 of the half-pin 400 of the transport segment 50, so the plate 104 cannot be removed until the half-pin sleeve 106 is removed (see, for example, Figure 1A). Furthermore, the first guide wire 192 must be removed before the plate 104 can be removed (see, for example, Figure 5J). Once the half-pin sleeve 106 and the first guide wire 192 are removed (see, for example, Figures 5H-5J and 5L), the plate 104 can be removed laterally from the transport segment 50 in a direction approximately perpendicular to the lateral direction from which the second and third guide wires 190, wire sleeve 108, and half-pin sleeve 106 were removed. The plate 104 can be slid out from the transport segment 50 and brought out from below the skin flap through the opening of the posterior incision 380 (see, for example, Figure 5G). The plate 104 is removed by moving the channel 134 along the inserted half pin 400. Figure 5P shows the system after step 324, with the plate 104 of the template 100 (see, for example, Figure 5O) removed, the half pin 400 inserted into the transport segment 50, the half pin 400' inserted into the main body portion 52, and the distractor 200 attached to the half pins 400, 400' (skin and subcutaneous tissue are not shown).

[0099] Step 326 of method 300 shown in Figure 4 may include cutting the bone to free the transport segment 50. This may include cutting the remaining edges of the transport segment 50. The remaining edges of the transport segment 50 can be cut after the distractor 200 has been attached to the half-pin 400 of the transport segment 50 and the half-pin 400' of the body portion 52. Once all edges have been cut, the transport segment 50 may be movable relative to the body portion 52 of the bone. In particular, the posterior side of the transport segment 50 may be cut. Since the skin flap is open toward the posterior side, the posterior side of the transport segment 50 may be easily accessible. In some embodiments, the wound can be closed around the transport segment 50. For example, the skin flap can be sutured to nearby skin.

[0100] Step 328 of method 300 shown in Figure 4 may include rotating or turning the actuator 206 in a first direction to move the transport segment 50 laterally away from the bone portion 52. As described above, the actuator 206 may include a knob 222 and a screw 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 body portion 52 is bicortical, the upper beam 202 can be moved upward relative to the lower beam 204, and as a result, the half-pin 400 inserted into the transport segment 50 moves upward relative to the half-pin 400' inserted into the body portion 52. Thus, when the knob 222 of the actuator 206 is rotated in a first direction, the transport segment 50 can be moved upward away from the body portion 52 (i.e., traction). Figure 5Q shows the bone transport system after the transport segment 50 has been tractioned according to step 328 (skin and subcutaneous tissue are not shown). In the towing position, the transport segment 50 is moved upward, away from the adjacent bone section 52. Furthermore, the upper beam 202 and the lower beam 204 are spaced apart from each other, and the threaded rod 224 and support column 228 can be seen in the space between beams 202 and 204.

[0101] Step 330 of method 300 shown in Figure 4 may include rotating the actuator 206 in a second direction to move the transport segment 50 laterally toward the body portion 52. This step may be performed after or during treatment. When the half-pins 400' inserted into the body portion 52 are bicortical, the upper beam 202 can be moved downward relative to the lower beam 204, and as a result, the half-pins 400 inserted into the transport segment 50 move downward relative to the half-pins 400' inserted into the body portion 52. Therefore, when the knob 222 of the actuator 206 is rotated in a second direction, the transport segment 50 can be moved downward toward the body portion 52 (i.e., contracted).

[0102] Figure 6A shows a cross-sectional view of a bone with half-pins inserted into a transport segment 50 and a body portion 52 according to several embodiments of the present disclosure. The bone may include a softer inner core of the medullary duct containing bone marrow 54, surrounded by outer layers of harder cortical bone 56, 58. In some cases, the half-pin 404 (referred to as half-pin 400' in Figures 1A to 5Q) inserted into the body portion 52 of the bone may be bicortical, i.e., extending across the bone and penetrating both the proximal portion 56 and the distal portion 58 of the cortical bone. The half-pin 402 (referred to as half-pin 400 in Figures 1A to 5Q) inserted into the transport segment 50 of the bone may be monocortical, rather than bicortical. Thus, the monocortical half-pin 402 may extend partway through the bone and pass only through the proximal portion 56 of the cortical bone. Therefore, the transport segment 50 does not have to extend across the bone, but only needs to penetrate the bone partway. In this way, the transport segment 50 may be more easily movable relative to the main body 52. ​​For example, the transport segment 50 may include a portion of the proximal part 56 of the cortical bone and does not have to include the bone marrow from the medullary cavity 54 or the distal part 58 of the cortical bone.

[0103] In some cases, the half-pins 402 of the transport segment 50 are inclined at an angle α with respect to the bone surface. The angle α may be any suitable value. For example, α may be any angle in the range of 0 to 90 degrees. In some embodiments, α may 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 may be at an angle of 15 degrees with respect to the bone surface. In some cases, the half-pins 402 may be at the same angle or different angles with respect to the bone surface. Although the half-pins 402 are shown inclined inward toward each other, the half-pins 402 may also be inclined outward toward each other or in the same direction.

[0104] In some cases, the half-pins 404 of the main body portion 52 are inclined at an angle β with respect to the bone surface. The angle β may be any suitable value. For example, β may be any angle in the range of 0 to 90 degrees. In some embodiments, β may 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 may be at an angle of 15 degrees with respect to the bone surface. In some cases, the half-pins 404 may be at the same angle or different angles with respect to the bone surface. Although the half-pins 404 are shown inclined inward toward each other, the half-pins 404 may be inclined outward toward each other, or inclined in the same direction.

[0105] Figure 6B shows a side view of the transport segment 50 according to one or more embodiments. As described above, the multiple holes surrounding the plate 104 (see, for example, Figures 1A to 1D) may be inclined inward to produce a transport segment 50 having a slight chamfer at the bottom such that the periphery of the transport segment 50 is inwardly slanted. The angle θ of the sides of the transport segment may be the same for all sides, or one side may be inclined at angle θ1 and one side at angle θ2. The sides may be inclined at any suitable angle θ. For example, θ1 and θ2 may be any angles in the range of 0° to 15°. For example, angles θ1 and / or angles θ2 may be 0°, 1°, 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, or 15°. This prevents the transport segment 50 from interfering with the surrounding bone portion 52. Furthermore, the chamfering can also prevent the transport segment 50 from moving downward into the bone's medullary cavity after it has been cut.

[0106] Figures 7A and 7B show another embodiment of template 101 for use in a bone transport system. Figure 7A is an exploded view of template 101. Figure 7B is a bottom view of the upper plate 102 on which the clips 188 are located. Unlike template 100 shown in Figures 1A to 1D, template 101 shown in Figures 7A and 7B includes two plates 102 and 171, namely the upper plate 102 and the lower plate 171. The lower plate 171 shown in Figures 7A and 7B may be substantially the same as the plate 104 shown in Figures 1A to 1D. The lower plate 171 may have a top surface 172, a bottom surface 176, two ends 178, and two sides 180 positioned 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 may be substantially circular. A channel 186 may be present extending from the opening 182 to one side 180. However, the lower plate 171 shown in Figures 7A and 7B does not have to have a tab 140. Furthermore, unlike the opening 130 of the plate 104 shown in Figures 1A to 1D, the opening 182 of the lower plate 171 shown in Figures 7A and 7B does not have threads. In addition, the extension 184 of the lower plate 171 shown in Figures 7A and 7B includes a recess 185 for a clip 188 that connects the upper plate 102, which is not included in the plate 104 shown in Figures 1A to 1D, to the lower plate 171.

[0107] The upper plate 102 may have a top surface 110, a bottom surface 112, two ends 114, and two sides 116 positioned between the top surface 110 and the bottom surface 112 and between the two ends 114. Furthermore, the upper plate 102 may include two elongated openings 118 extending through the upper plate 102. The elongated openings 118 may be oblong, but in some cases may be any suitable shape, including, for example, rectangular, ovate, egg-shaped, elliptical, or ovoid.

[0108] The upper plate 102 may include a recess 121 defined in or recessed in the bottom surface 112 of the upper plate 102. The recess 121 may be sized and shaped to fit the lower plate 171. In some cases, the lower plate 171 may fit into the recess 121 so as to be partially or completely positioned within the upper plate 102. The recess 121 may be centered on the bottom surface 112, or positioned along the edge 114 or side 116 of the bottom surface 112. In some embodiments, the recess 121 is absent, and the lower plate 171 is positioned below the upper plate 102. In some embodiments, the width and / or length of the lower plate 171 is smaller 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.

[0109] 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 may be arranged around the perimeter of the upper plate 102. In some cases, the plurality of holes 120 may be arranged around a recess 121 in the bottom surface 112 of the upper plate 102. In some embodiments, the plurality of holes 120 may be arranged around only three sides or even fewer sides of the upper plate 102. The plurality of holes 120 of the upper plate can be used as a guide for drilling holes in bone to define the perimeter of the bone transport segment 50, as will be described in more detail below (see, for example, Figures 5P to 5Q). Thus, in the case of the template shown in Figures 7A and 7B, the T-shaped drill guide 500 shown in Figures 3A to 3F may not be necessary for drilling holes around the transport segment 50.

[0110] The opening 182 of the lower plate 171 may be aligned with the elongated opening 118 of the upper plate 102. In some cases, the extension 184 may extend into or through the elongated opening 118.

[0111] Furthermore, the upper plate 102 may include a tab 115 having an upper recess 117 and a bottom recess 117. The recesses 117 may allow a physician to easily grasp and / or manipulate the upper plate 102 using their hand or an instrument (e.g., forceps) (not shown).

[0112] In some embodiments, as shown in Figures 6A and 6B, a plurality of holes 120 surrounding the template 100 can be inclined inward to generate a transport segment 50 having a slight chamfer at the bottom. Thus, the plurality of holes 120 may be inclined to generate the transport segment 50 described with reference to Figures 6A and 6B.

[0113] In some embodiments, the upper plate 102 may include a projection 142 that protrudes from the bottom surface 112 or the wall of the recess 121 into the recess 121. The projection 142 may define a recess or cavity 141 configured to fit a clip 188. Thus, the cavity 141 of the projection 142, 141 on the upper plate 102 and the clip recess 185 of the extension 184 on the lower plate 171 may allow the lower plate 171 to be inserted into the upper plate 102 in only one orientation. In some embodiments, the clip 188 may allow the lower plate 171 to be snapped into and out of the recess 121 of the upper plate 102.

[0114] Figures 8A and 8B show another embodiment of the distractor 890 according to some embodiments of the present disclosure. Figure 8A is a perspective view of the distractor 890, and Figure 8B is a perspective view of the distractor 890 with the motor cover 897 removed. The distractor 890 shown in Figures 8A and 8B is similar to the distractor 200 shown in Figures 2A to 2D. The distractor 890 shown in Figures 8A and 8B includes the same upper beam 202, lower beam 204, and half-pin holders 208, 208'. However, the distractor 890 of Figures 8A and 8B uses an electric actuation mechanism 896. The actuation mechanism shown in Figures 8A and 8B uses a power actuator 896 together with gears 891, 892 to actuate the distractor 890 between a traction position and a retraction position. The actuator motor 896 has a drive shaft including a first gear 891. The actuator 896 may be driven in any suitable manner. For example, the actuator 896 may be a battery-powered motor. The first gear 891 is interconnected with the second gear 892. The second gear 892 is coupled to a threaded rod 893 extending through the upper beam 202 and the lower beam 204. For stability, support columns 895 may be present on both sides of the threaded rod 893. The motor cover 897 may be shaped and configured to cover the gears 891 and 892 of the motor 896. The motor 896 can be operably coupled to a power supply 898 and a processor circuit 899. The first gear 891 can be rotated using the power supply 898. This causes the second gear 892 to rotate, and therefore the threaded rod 893 to move up and down, moving the upper beam 202 and the lower beam 204 relative to each other. In some cases, rotating the first gear 891 in a first direction causes the upper beam 202 and the lower beam 204 to move away from each other (tension), and rotating the first gear 891 in a second direction causes the upper beam 202 and the lower beam 204 to move towards each other (contraction).

[0115] In some embodiments, the processor circuit 899 may include a processor and a memory for storing computer-readable instructions. The processor circuit 899 may be operably coupled to a power supply 898 and / or motor 896 to control the movement of motor 896. For example, the processor circuit 899 may move a first gear 891 in a first direction to cause traction of the distractor 890, or move it in a second direction to cause contraction of the distractor 890.

[0116] The processor circuit 899 may include a wireless communication module that enables the processor circuit 899 to communicate wirelessly (for example, via Wi-Fi or Bluetooth®) with a remote computer system. The computer system can transmit signals to the wireless communication module to control the power supply 898 and / or the motor 896.

[0117] In some embodiments, the lateral bone transport device may include an electric engine with an automatic controller for a traction / compression module that potentially includes sinusoidal traction and compression speeds.

[0118] In some embodiments, the distractor 890 includes one or more sensors that measure, for example, blood volume, blood flow velocity, angiogenesis / neovascularization, strain, displacement, or any other suitable measurement. The processor circuit 899 can store the measurement data obtained by one or more sensors and / or transmit the measurement data to a remote computer system. These measurement data can be analyzed by either the processor in the processor circuit 899 or the computer system. For example, the processor circuit 899 / computer system can compare the measurement data with stored program values ​​and, based on such comparison, control the remodeling during traction, compression, and densification. Using measurement data and other optional data (e.g., patient data), a treatment protocol can be predicted, determined, or proposed. The power supply 898 and / or motor 896 can then be operated according to the treatment protocol. In some embodiments, artificial intelligence (AI) can be used to analyze one or more measurements and predict the treatment protocol. The AI ​​model can analyze the correlation between physiological data detected for the patient and what has been reported in clinical studies to suggest to the physician variations in treatment parameters that differ from what was planned during treatment. Furthermore, the AI ​​model can also alert to anomalies between standard physiological parameters in this treatment and parameters detected for the patient. For example, if the level of oxygenation in the surrounding soft tissue is higher than a set point, the AI ​​module can adjust the travel speed (e.g., 0.25 mm per day instead of the standard 1 mm per day), thereby creating better conditions for neovascularization by reducing the level of oxygenation. Alternatively, in another example, when enhanced neovascularization is detected adjacent to a transport segment, the rate of lateral movement can be increased, and this increased daily movement of the transport segment can avoid premature densification between the transport segment and the surrounding bone, which would lead to disruption of bone transport.

[0119] In some embodiments, the lateral bone transport system may provide other treatments in addition to bone transport. For example, the bone transport system may include a module for delivering chemical / biological agents. In some embodiments, the lateral bone transport device may include a module for mechanical stimulation of neovascularization and for increasing blood volume and flow.

[0120] In some embodiments, the distractor may be attached to the bone using half-pins 400 and also to a ring 900 used in an external fixation system. Figure 9A shows a distractor 200 coupled to the bone and ring 900. The distractor 200 in Figure 9A is the same distractor 200 shown in Figures 2A to 2D, and therefore its components / parts will not be described in detail here (see the description 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 main body portion 52 of the bone at one end of the transport segment 50. At the other end of the transport segment 50, the lower beam 204 is attached to the 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 it into the half-pin holder 208 and tightening the half-pin holder 208. The half-pin holder 208 may need to be rotated more than when attaching it 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 tightening of the half-pin holder 208 around the threaded rod 903 is substantially the same.

[0121] The threaded rod 903 may extend through a hole in the ring 900. The bolt 904 can be screwed into the threaded rod 903 on both sides of the ring 900. Thus, the ring 900 can be secured between the bolts 904 by tightening the bolts 904 on both sides of the ring 900.

[0122] Once the distractor 200 is secured to the half-pins 400, 400' and ring 900, the traction and retraction of the distractor 200 function in the same manner as described above with reference to Figures 2A to 2D.

[0123] In some embodiments, the distractor 200 may be attached to the bone transport segment 50 using half-pins 400 and may also be attached to two rings 900 used in an external fixation system. Figure 9B shows the distractor 200 coupled to the bone and the two rings 900. The distractor 200 in Figure 9B is the same distractor 200 shown in Figures 2A to 2D, and therefore its components / parts will not be described in detail here (see the description above). Furthermore, the ring connector 902 shown in Figure 9A is the same as the ring connector 902 shown in Figure 9B. Similar to Figure 9A, the upper beam 202 of the distractor 200 is coupled to two half-pins 400 inserted into the bone transport segment 50. In Figure 9B, both ends 212 of the lower beam 204 are coupled to the rings 900 via the ring connectors 902, as described above. Once the distractor 200 is secured to the half-pin 400 and ring 900, the traction and retraction of the distractor 200 function in the same manner as described above, with reference to Figures 2A to 2D.

[0124] While the distractors 200 shown in Figures 2A to 2D are shown in Figures 9A and 9B, please understand that any suitable distractor, including the distractor 890 shown in Figures 8A and 8B, can also be used with one or more rings 900.

[0125] Figures 10A to 10L show various embodiments of the template according to the embodiments described herein. Figure 10A is an example of a template 660 having two openings 661 that fit a half pin 400 and a plurality of holes 662.

[0126] Figure 10B is a side view of template 666. Template 666 includes an opening 664 having an extension 665 that extends upward from the top of template 666. The opening 664 does not have to be inclined and may be oriented approximately perpendicular to the top and bottom surfaces of template 666. Figure 10C is an example of template 667 similar to template 666 shown in Figure 10B. In template 667 shown in Figure 10C, the opening 664 is inclined with respect to the top and bottom surfaces of template 667. The opening 664 may also be inclined outward toward the ends of template 667.

[0127] Figure 10D shows an example of a template 668. The template 668 in Figure 10D includes a number of holes 669 encircling the template 668 and a row of holes 670 from the holes 669 on one side of the template 668 to the holes on the other side. This makes it possible to measure and cut transport segments 50 of multiple sizes (see, for example, Figures 5P and 5Q) using a single template 668. Figure 10E is an example of a template 672 that includes a number of holes 673 encircling the template 672. The number of holes 673 may be connected by a series of channels. Thus, the template 662 can be used to perforate a transport segment 50 and cut between the holes to form the transport segment 50 (see, for example, Figures 5P and 5Q).

[0128] Figure 10F shows an example of a template 674 formed from two parts. The template includes two inclined openings 675 and a gap 676 between the two openings 675. Thus, the openings 675 may be located on separate parts of the template 674. The gap 676 can pass from one side of the template 674 to the other. In some cases, the gap 676 may be straight. Figure 10G shows a top view of a template 674 in which the gap 676 is not straight. Instead, one part has a projection 677 and the other part has a recess 678 that fits into the projection 677. The shape of the template 674 in Figure 10G can provide further stability and prevent the parts from moving relative to each other. Figure 10H shows a template 680 consisting of two parts, with an opening 681 located along a gap 682 and a hinge 683 located between the parts at one end of the template 680.

[0129] Figure 10I is a top view of an example of a template 684 consisting of two parts. The template 684 includes two openings 685 located along a slit 686 that extends from one end of the template 684 to the other end. A hinge or locking plate 687, which can separate the parts from each other and move them away from each other, is located along the slit 686.

[0130] Figures 10J to 10L show a template 688 consisting of two parts, similar to template 101 shown in Figures 7A and 7B. Template 688 includes an upper plate 689 and a lower plate 690. The lower plate 690 can fit into a recess 693 at 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, which are not necessarily elongated. Furthermore, the lower plate 690 may include a channel 694 extending from the openings 692 to the side of the lower plate 690. The upper plate 689 may include a plurality of holes 695 arranged around the recess 693.

[0131] While various embodiments based on the principles of this disclosure have been described above, it should be understood that these are merely examples and not limitations. Therefore, the scope and breadth of the present invention should not be limited by any of the exemplary embodiments described above, but should be defined solely in accordance with the claims arising from this disclosure and their equivalents. Furthermore, although the above advantages and features are provided in the described embodiments, the application of such issued claims is not limited to processes and structures that achieve any or all of the above advantages.

Claims

1. A template for a lateral bone transport system, Top surface and, The bottom surface opposite to the top surface, The first aspect and, The second side opposite to the first side, A first opening extending from the top surface to the bottom surface, A channel extending between the top surface and the bottom surface, and extending between the first opening and the first side surface of the plate, wherein the width of the channel is smaller than the width of the first opening, A plate equipped with, A pin sleeve configured to fit into the first opening, wherein the outer width of the pin sleeve is greater than the width of the channel, A template that includes the following features.

2. The template according to claim 1, further comprising a wire sleeve configured to fit into the pin sleeve.

3. The template according to claim 2, wherein the inner width of the wire sleeve is smaller than the inner width of the pin sleeve.

4. The template according to claim 1, wherein the first opening is inclined toward the end of the plate such that when the pin sleeve is placed in the first opening, the pin sleeve is inclined with respect to the upper surface of the plate.

5. The aforementioned plate is A first end extending between the first side and the second side, A second end, opposite to the first end, extends between the first side and the second side, The first side surface, the first end, the second side surface, and the multiple corners between the second end, Furthermore, The aforementioned template is Guide axis and A guide opening aligned with the aforementioned guide shaft, An alignment structure configured to engage with the first corner of the plurality of corners, A drill guide equipped with, Furthermore, The aforementioned alignment structure is, A first guide wall configured to engage with either the first side or the second side, A second guide wall configured to engage with either the first end or the second end, A base surface configured to engage with the upper surface, Equipped with, When the alignment structure engages with the first corner of the plate, the guide shaft is inclined with respect to the upper surface of the plate. The template according to claim 1.

6. A second opening extending from the top surface to the bottom surface, A second channel extending between the upper surface and the bottom surface, and extending between the second opening and the first side surface of the plate, A guide pin opening extending from the top surface to the bottom surface and positioned on the longitudinal axis between the first opening and the second opening, The template according to claim 1, further comprising:

7. The template according to claim 1, wherein the plate further comprises an extension that extends upward around at least a portion of the first opening.

8. A distractor for a lateral bone transport system, A first beam comprising a first opening and a first movable half-pin holder, A second beam comprising a second opening and a second movable half-pin holder, wherein the length of the second beam is greater than the length of the first beam, and the first and second movable half-pin holders are displaced in the longitudinal and radial directions, An actuator comprising a knob and a screw rod positioned at 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 the 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, A distractor equipped with this feature.

9. The obstructor according to claim 8, wherein the actuator is rotatable through a plurality of discrete rotational positions.

10. The distractor according to claim 9, wherein each of the plurality of discrete rotational positions is located at a predetermined distance from an adjacent discrete rotational position.

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

12. The distractor according to claim 8, wherein the first movable half-pin holder and the second movable half-pin holder are configured to pivot between a plurality of angular positions.

13. The first movable half-pin holder is configured to hold the first pin, The first movable half-pin holder is configured to be tightened around the first pin so that the first pin is held in a first angular position among the plurality of angular positions. The distractor according to claim 12.

14. The second movable half-pin holder is configured to hold the second pin, The second movable half-pin holder is configured to be tightened around the second pin so that the second pin is held in a second angular position among the plurality of angular positions. The distractor according to claim 13.

15. The distractor according to claim 14, wherein the first angular position and the second angular position are different.

16. The disruptor according to claim 8, wherein the threaded rod is screwed into and received on the second beam such that the actuator is configured to move the first beam relative to the second beam.

17. The distractor according to claim 8, further comprising a support column coupled to at least one of the first beam or the second beam and positioned immediately adjacent to the threaded rod.

18. A kit for a lateral bone transport system, Top surface and, The bottom surface opposite to the top surface, The first aspect and, The second side opposite to the first side, An opening extending from the top surface to the bottom surface, A channel extending between the upper surface and the bottom surface, and between the opening and the first side surface of the plate, wherein the width of the channel is smaller than the width of the opening, A plate equipped with, A pin sleeve configured to fit into the opening, wherein the outer width of the pin sleeve is greater than the width of the channel, A template that includes, A first beam comprising a first opening and a first movable half-pin holder, A second beam comprising a second opening and a second movable half-pin holder, wherein the length of the second beam is greater than the length of the first beam, and the first movable half-pin holder and the second movable half-pin holder are displaced in the longitudinal direction, An actuator comprising a knob and a screw rod positioned in the first opening or the second opening of the first beam and the second beam, wherein the knob is configured to rotate in a first direction to increase the 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, A destructor equipped with, Multiple pins, A kit that includes the following:

19. The aforementioned plate is A first end extending between the first side and the second side, A second end, opposite to the first end, extends between the first side and the second side, The first side surface, the first end, the second side surface, and the multiple corners between the second end, Furthermore, The aforementioned kit is Guide axis and A guide opening aligned with the aforementioned guide shaft, An alignment structure configured to engage with a first corner among the plurality of corners, A drill guide, further equipped with The aforementioned alignment structure is, A first guide wall configured to engage with either the first side or the second side, A second guide wall configured to engage with either the first end or the second end, A base surface configured to engage with the upper surface, Equipped with, When the alignment structure engages with the first corner of the plate, the guide shaft is inclined with respect to the upper surface of the plate. The kit according to claim 18.

20. The kit according to claim 18, wherein the width of at least one of the plurality of pins is smaller than the width of the channel.

21. A method for performing bone transport, Top surface and, The bottom surface opposite to the top surface, The first aspect and, The second side opposite to the first side and A plate equipped with, A template containing the following is placed on top of the bone transport segment: The template is held in a first position relative to the bone, Using the template, a plurality of holes are formed in the bone adjacent to at least the first and second sides, Using the aforementioned multiple holes, the transport segment is cut from the bone. A method that includes doing so.

22. Using the aforementioned template to form multiple holes in the bone is, The template is engaged with the drill guide, The drill bit is passed through the drill guide to form the plurality of holes. The method according to claim 21, which includes the following:

23. The template further comprises a guide pin opening, The above method involves inserting a first guide wire through the guide pin opening. The method according to claim 21, further comprising the following:

24. The method according to claim 21, further comprising placing the template on the transport segment and then inserting a half pin into the transport segment through a pin sleeve attached to the template.

25. The template includes a first opening for receiving the pin sleeve, The pin sleeve is provided with a second opening, The template further comprises a wire sleeve configured to be inserted into the second opening of the pin sleeve and having a third opening. The method according to claim 24.

26. The method according to claim 25, further comprising inserting a second guide wire into the transport segment of the bone through the third opening of the wire sleeve before inserting the half pin into the transport segment through the pin sleeve.

27. The method according to claim 26, further comprising inserting the second guidewire through the third opening of the wire sleeve, and then passing the skin flap over the template and the second guidewire by extending the wire sleeve through the hole in the skin flap.

28. The method according to claim 26, further comprising inserting the second guidewire into the transport segment of the bone through the third opening of the wire sleeve, and then removing the second guidewire and the wire sleeve.

29. The method according to claim 24, further comprising removing the pin sleeve upward along the longitudinal axis of the half pin after cutting the transport segment.

30. The method according to claim 29, further comprising removing the pin sleeve, and then laterally removing the plate along an axis substantially perpendicular to the longitudinal axis of the half pin.

31. A distractor for a lateral bone transport system, A first beam comprising a first opening and a first movable half-pin holder, A second beam comprising a second opening and a second movable half-pin holder, wherein the length of the second beam is greater than the length of the first beam, and the first and second movable half-pin holders are displaceable in the longitudinal and radial directions, Electric actuator and Equipped with, The aforementioned electric actuator is A screw rod positioned in the first opening of the first beam and the second opening of the second beam, A motor operably coupled to the screw rod is configured to rotate the screw rod in a first direction to increase the distance between the first beam and the second beam, and to rotate it in a second direction to decrease the distance between the first beam and the second beam. Equipped with, Distractor.

32. The actuator is A first gear coupled to the motor so as to be rotated by the motor, A second gear is connected to the screw rod such that it is rotated by the first gear when the motor rotates the first gear, and rotates the screw rod when rotated by the first gear. The disruptor according to claim 31, further comprising:

33. The system further comprises a power supply and a processor circuit operably coupled to at least one of the motor or the power supply, The processor circuit is configured to control at least one of the motor or the power supply. The distractor according to claim 32.

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

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

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

37. The disruptor according to claim 36, wherein the processor circuit is configured to control at least one of the power supply or motor in accordance with the generated treatment protocol.

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

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