Wire-guide system for external fixation devices and methods of use or manufacture

Abstract

Systems and methods for a wire guide system. The wire guide system includes a guide body, a first and second lumen guides, and at least one pin. The guide body extends in a first plane and is configured to be positioned about a periphery of the extremity to arrange a first side having a first passage approximately opposite a second side having a second passage when the extremity is positioned between the first side and the second side of the guide body. The first lumen guide extends from the first passage and the second lumen guide extends from the second passage. Each of the first lumen guide and the second lumen guide are configured to extend in a direction perpendicular to the first plane. The at least one pin extends transversely from the guide body and is configured to engage a reciprocal aperture in a bracket of a fixation device.

Description

WTRE-GUIDE SYSTEM FOR EXTERNAL FIXATION DEVICES AND METHODS OFUSE OR MANUFACTURESTATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0001] Not Applicable.RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 578,342, titled " SEMI-CIRCULAR WIRE-GUIDE FOR CIRCULAR EXTERNAL FIXATION" and filed August 23, 2023. The entirety of which is incorporated herein by reference.BACKGROUND

[0003] The disclosure relates generally to external fixation devices, and more specifically, to systems and methods for mitigating issues related to installing external fixation devices.

[0004] External fixation devices are well known in medical care and commonly placed to address a variety of conditions involving the need to treat deformities, such as fractures, shattered bones, or other deformities of a skeletal structure. In particular, fixation devices can be used to ensure the skeletal structure is in an optimal position during a healing process. When an intra-articular fracture occurs or a comminuted fracture occurs, a kirschner wire is clinically used for temporary fixation or traction. When the kirschner wire is implanted, a doctor generally drives in the kirschner wire directly or through a kirschner wire guide, or guider.

[0005] When the guider is not used, the needle inserting position and the needle withdrawing position are a function of the doctor’s decision making and skill. For any of a number of reasons, without the use of a guider, undesirable needle inserting and withdrawing positions and angles often result. However, even the guider is used, this is no guarantee of proper or desirable positioning. For example, when the guider is used, the kirschner wire is guided and positioned only through one guider on one side of the affected limb. Although the needle inserting position can be determined through the guider, the needle outlet position and the needle outlet angle are uncontrollable. As a result, even when using a guider, the implantation position of the kirschner wire cannot be accurately controlled. Unfortunately, if the implantation position is not ideal, the implantation operation needs to be repeated for many times, which inflicts greater trauma on the patient and extends the operation.

[0006] After the Kirschner wire is positioned, the position of the Kirschner wire is typically validated using medical imaging. When the position of the Kirschner wire is determined via imaging to be improper, the Kirschner wire needs to be implanted again and the imaging is performed again. Of course, even beyond the further trauma to the patient and the operational inefficiencies, the imaging is typically c-arm fluoroscopy, which means that repeated imaging subjects the patient to repeated doses of ionizing radiation.

[0007] Aa a result, a variety of guides, taps, and drills have been developed to try to assist with proper placement of the Kirschner wires. However, each suffers from at least one of the shortcomings listed above, or is incompatible with the overall care protocols.

[0008] Therefore, it would be desirable to provide systems and methods that empower physicians and surgeons to more-preci sely position orthopedic tools, improve the accuracy of an orthopedic surgery, and reduce the need to subject the patient to radiation to validate or guide replacement of orthopedic tools.BRIEF SUMMARY

[0009] The present disclosure overcomes the aforementioned drawbacks by providing systems and methods for deploying an orthopedic tool, such as a Kirschner wire, with greater control and accuracy without relying on physician skill or variability to control against the multitude of deployment variables that can result in the orthopedic tool being erroneously deployed or requiring adjustment or wholesale removal and redeployment. A guidance system is provided that includes a wire guide that is adjustable and can be deployed proximate to an affected limb and guide from multiple sides of the limb. Furthermore, the guidance system can be compatible with other components of the care protocol, such as external fixators or frames..

[0010] In one configuration, a guide system for deploying an orthopedic tool through an extremity of a patient can include a guide body extending in a first plane and configured to be positioned about a periphery of the extremity to arrange a first side having a first passage approximately opposite a second side having a second passage when the extremity is positioned between the first side and the second side of the guide body. A first guide can extend from first passage and a second lumen guide can extend from the second passage. Each of the first lumen guide and the second lumen guide can be configured to extend in a direction perpendicular to the first plane from a proximal end engaged with the guide body to a distal end proximate to the extremity whenthe extremity is positioned between the first side and the second side of the guide body to thereby present a trajectory for extending the orthopedic tool through the extremity from the first lumen guide, through the extremity, and to the second lumen guide. At least one pin can extend transversely from the guide body and can be configured to engage a reciprocal aperture in a bracket of a fixation device configured to be constructed about the extremity.

[0011] The first lumen guide and the second lumen guide can be configured to move through the respective first passage and second passage to adjust a position of the distal end relative to the guide body and the extremity when positioned in the guide body.

[0012] The guide body can be configured to telescope to extend along the first plane.

[0013] The first passage and second passage can include threads configured to engage reciprocal threads formed on the first lumen guide and the second lumen guide to adjust a position of the distal end to or from the guide body to engage the extremity when arranged within the guide body. The first lumen guide and the second lumen guide can comprise a head formed at the proximal end that is sized to be larger than the first passage or the second passage to secure the first lumen guide and the second lumen guide within the guide body.

[0014] The at least one pin can include two pins. A first of the two pins can be arranged proximate the first passage and a second of the two pins can be arranged proximate to the second passage.

[0015] The guide system can include arms that extend radially from the guide body to engage an extremity when arranged within the guide body. The arms can include include four arms spaced radially along the guide body.

[0016] In another configuration, a system for treating an extremity can include a fixation device that can include a plurality of brackets. The plurality of brackets can each define a bracket plane and can each include bracket apertures. A wire guide system including a guide body that can extend in a first plane, at least one lumen guide that can extend through the guide body and include an entry side, an exit side, and an aperture, the aperture extending from the entry side to the exit side, and at least one pin that can extend from the guide body in a direction perpendicular to the first plane to engage at least one of the bracket apertures in at least one of the plurality of brackets to position the guide body to at least partially surround the extremity when the fixation device is deployed to the extremity. The at least one lumen guide can be moveable through the guide body to position the exit side proximate to the extremity such that a wire being inserted in the entry side of the at least onelumen guide and extending through the exit side of the at least one lumen guide is positioned to enter the extremity at a predetermined insertion point on the extremity.

[0017] The guide body can be configured to telescope to extend along the first plane and about the extremity when positioned within the guide body.

[0018] The at least one lumen guide can include two lumen guides arranged on opposing sides of the guide body. The at least one pin can include two pins, each of the two pins can be arranged approximate respective to one of the two lumen guide and can be configured to extend transversely to the first plane. The two lumen guides can be arranged on opposing sides of the guide body present a continuous passage extending therebetween to receive the wire. The first plane can extend parallel to the bracket plane when the at least one pin is engaged with the at least one of the bracket apertures.

[0019] The system can include at least one arm extending in the first plane radially inward from the guide body. The at least one pin can extend from the at least one arm.

[0020] In another configuration, a method for deploying an orthopedic tool to an extremity can include constructing a fixation device about the extremity using a plurality of brackets, at least one bracket including bracket apertures; connecting a guide system to the fixation device using at least one pin extending transversely from a first plane of a guide body to be received in a bracket aperture of the at least one bracket; adjusting at least one of a first lumen guide and a second lumen guide to define a wire trajectory extending from the first lumen guide, through the extremity, and through the second lumen guide, wherein each of the first lumen guide and a second lumen guide extend through the guide body to be arranged on opposing sides of the extremity; and pushing a wire through the first lumen guide to pass through the extremity and be received in the second lumen guide.BRIEF DESCRIPTION OF DRAWINGS

[0021] The disclosure will be better understood and features, aspects, and advantages other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such detailed description makes reference to the following drawings which may not be drawn to scale.

[0022] FIG. 1 A is an illustration of an external fixator device for use with the present disclosure installed on a patient.

[0023] FIG. IB is an illustration of a traditional wire guide system.

[0024] FIG. 2 is a perspective view of a guide system according to the present disclosure.

[0025] FIG. 3 is a bottom plan view of a guide body of the guide system of FIG. 2.

[0026] FIG. 4 is a side elevational view of the guide body of FIG. 3

[0027] FIG. 5 is a perspective view of a lumen guide of a guide system according to the present disclosure.

[0028] FIG. 6 is a side elevational view of the lumen guide of FIG. 5.

[0029] FIG. 7 is a front elevational view of the lumen guide of FIG. 5.

[0030] FIG. 8 is a top plan view of another configuration of the guide system according to the present disclosure.

[0031] FIG. 9 is a side elevational view of the guide system of FIG. 8.

[0032] FIG. 10 is a top plan view of the guide system of FIG. 2 with a wire, according to the present disclosure.

[0033] FIG. 11 is a top plan view of the guide system of FIG. 8 with a wire, according to the present disclosure.

[0034] FIG. 12 is an illustration of the external fixator device of FIG. 1A with the guide system of FIG. 2, according to the present disclosure.

[0035] FIG. 13 is a top plan view of the guide system with a wire of FIG. 11 with a component of the external fixator device of FIG. 1A, according to the present disclosure.DETAILED DESCRIPTION

[0036] As noted above, in some instances, it may be necessary to stabilize bone structure, particularly when a fracture or fragmentation of bone structure has occurred (e.g., an intra-articular fracture, a comminuted fracture, etc.). Stabilization of bone structure is a necessity to ensure the bone structure heals properly. In such instances, an external fixation device that stabilizes (e.g., secures, locks in place, fastens, brace, support, etc.) the bone structure may be used. An example of an external fixation device 10 (e.g., fixation device) is shown in FIG. 1 A. In a non-limiting example, the fixation device 10 is a circular external fixator device.

[0037] In practice, a fixation device generally extends past a point of medical interest (e.g., a location of surgery, a location of a bone break, trauma location, etc.) to provide increased stability to the point of medical interest. A trauma location 12 is on an extremity 14 (e.g., a limb, leg, foot, hand, etc.) of the patient. In the non-limiting example depicted in FIG. 1A, the extremity 14 is a leg and foot of the patient, with the trauma location 12 being on the foot. As depicted in FIG. 1A, thefixation device 10 extends past the trauma location 12. The extension of the fixation device 10 provides additional support and stability for the trauma location 12. In particular, the fixation device 10 extends beyond the trauma location 12 to provide ample support during the healing process. In other non-limiting examples, the fixation device 10 may be used to stabilize any other part of a patient’s body.

[0038] In practice, wires 16 are often used to secure the external fixation device to stabilize bone structure of a patient. In particular, Kirschner wires (e.g., K-wires) 16 are used in medical settings to stabilize bone structure. For example, wires 16 (e.g., Kirschner wires) are fastened to the fixation device 10. In the example depicted in FIG. 1A, wires 16 are secured to the external fixation device 10 to stabilize the extremity 14. In a non-limiting example, the wires 16 may include about a 1.6 mm diameter, although the systems and methods described herein are designed for use with any diameter wire.

[0039] As stated above, with existing fixation devices, such as the device 10 shown in FIG. 1A, wires 16 are secured to the device 10 to stabilize bone structure during a healing process to ensure proper healing. To do so, the wires 16 are inserted into bone structure within a trauma location to provide stability. In some non-limiting examples, the wires 16 are inserted completely through the bone structure. In other non-limiting examples, as illustrated, shorter wires 16’ are partially inserted in the bone structure and do not extend through the bone structure to be secured on opposing sides of the fixation device 10 but are instead partially inserted in the bone structure and secured to only one side of the fixation device 10. The systems and methods provided herein are configured to accommodate either protocol.

[0040] Generally, the fixation device 10 may include various frames, structures, or brackets 18. The brackets 18 are used to provide extension from the trauma location. The wires 16 are secured to the brackets. For example, as depicted in FIG. 1A, the wires 16 are secured to the brackets 18. Further, the brackets include bracket apertures 20, which allow for the brackets 18 to be secured together, and also allow other devices to be secured to the brackets 18, as discussed in greater detail below. In the non-limiting example shown in FIG. 1A, the fixation device 10 includes five brackets 18. In some non-limiting examples, the fixation device 10 may include fewer than 5 brackets 18. In other non-limiting examples, the fixation device 10 includes more than 5 brackets 18. Each of the brackets 18 define a plane (e.g., an axial plane, or a bracket plane) that is substantially parallel to the bracket 18. Further, as shown in the non-limiting example of FIG. 1 A, the brackets 18 of the fixationdevice 10 of the patient are substantially parallel or perpendicular to each other. The brackets 18 also include bracket apertures 20.

[0041] In some non-limiting examples, such as FIG. 1A, the wires 16 are extend substantially parallel to the brackets 18 and are connected directly the bracket 18 via a clamp 22. As described above, if a doctor is attempting to freely deploy the wires 16, the ultimate position of the wires 16 relative to the brackets 18 may be non-parallel. That is, a doctor attempting to deploy a wire 16 may find that the wire 16 extends in a plane that is not parallel to the planes defined by the brackets 18 when the wires are inserted through the bone. This creates the undesirable situation of needing to remove and re-deploy the wire 16, or, perhaps worse, to use the clamp 22 to hold a wire 16 that is not extending parallel to the plane of the bracket 18, which places undesirable stress on the patient’s extremity / bone.

[0042] Thus, when inserting the wires 16 through bone structure, a user (e.g., a doctor, a surgeon, or any medical personnel) must ensure that the wire is properly inserted into the bone structure in way that is compatible with the fixation bracket 10. In other words, the user must ensure that the wire 16 is being inserted into the patient at a proper location and angle (e.g., an angle relative to the patient’s limb) to avoid damaging any nerves, tissue, etc. Further, the user must also ensure that the wire 16 is being inserted into the proper location of the bone to best stabilize the bone. Still further, the doctor must ensure that the wire 16 is inserted to the bone in a way that allows the wire to be secured to the fixation device 10. This presents an incredibly number of variables for the user / doctor to manage.

[0043] Currently, doctors insert the wires 16 into the patient and then attempt to secure the wires to the fixation device 10. In some instances, the doctors have to continuously repeat the insertion of the wire 16 because the wire did not penetrate the correct bone structure, could not be secured correctly to the fixation device 10, or did not exit the patient correctly. For example, an insertion position of the wire 16 (e.g., where the wire is inserted into the patient) is determined, and performed, by the doctor. However, typically the exit position (e.g., where the wire exits the patient after being inserted through a bone) of the wire is theorized by the doctor, but often times the wire does not exit in the desired exit position. For example, once inserted, the wire 16 may contact undesired internal structure of the patient, which can result in the wire exiting at a different location than the exit position. Further, and more likely, the exact angle of the wire 16 was not correct at the insertion of the wire 16, which led to the wire 16 exiting at a location different than the exit location. Specifically,the wire 16 exiting the patient at a location different than the exit position is a particular issue when the doctor intends for the wire 16 to be inserted on a bracket of the fixation device along the plane defined by the bracket 18. Further, the wire 16 may be inserted incorrectly such that the wire 16 damages the patient, or increases the risk of damaging the patient. Thus, if the wire 16 is repeated inserted, the risk of damaging the patient is significantly heighted.

[0044] Additionally, when the wire 16 is inserted, a fluoroscopy image of the wire 16 is taken to determine if the wire 16 is in the correct location to stabilize the bone. Thus, when there is repeated insertion of the wire, the fluoroscopy is repeated, exposing the patient to more radiation. Therefore, there is a need to reduce or control the many variables and possible outcomes available.

[0045] Recognizing that freehand deployment of wires 16 is extremely challenging, some tools have been developed to assist users / doctors. Referring to FIG. IB, one such tool is a wire guide 24. A wire guide 24 may be used to provide consistent and steady insertion angles of wires 16 into the patient (e.g., a guide to guide wires during insertion). When a facture occurs (e.g., an intra-articular fracture occurs or a comminuted fracture occurs), a wire (e.g., a Kirschner wire, a K-wire, wire 16) may be deployed using a wire guide 24 to provide temporary fixation or traction. When the wire 16 is implanted, a doctor drives in the wire 16 directly or through the wire guide 24 (e.g., a Kirschner wire guide). When the wire guide 24 is not used, the wire inserting position (e.g., needle inserting position) and the wire withdrawing position (e.g., needle withdrawing position, exit position of the wire) are completely determined by the level of a doctor, and the situations of undesirable wire inserting and withdrawing positions and angles often occur. When the wire guide is used, the wire 16 is guided and positioned only through one side of the affected extremity. In other words, even with the wire guide 24, the doctor must manage many variables to ensure that the wire 16 is implanted through an insertion point 58 and exits at a desired exit point, without intersecting any undesirable (e.g., vessels, nerves, etc.) and remaining in a common plane. In this way, although the wire 16 inserting position can be carefully determined and the trajectory managed using the wire guide 24, the outlet angle is still uncontrollable, so that the implantation position of the wire 16 cannot be accurately controlled. If the implantation position is not ideal, the implantation operation needs to be repeated for many times, the operation efficiency is low, and the patient (e.g., the extremity of the patient) can be damaged more.

[0046] Referring to Fig. 2, a guide system 100 according to the disclosure can control these variable and drastically improve outcomes. The guide system 100 includes a guide body 102. Theguide body 102 may be semicircular in shape or may take other shapes that can receive an extremity. In some non-limiting examples, the guide body 102 is a half-circle. In other non-limiting examples, the guide body 102 form a telescoping guide body, which allows the guide body 102 to extend / contract in a circular or elliptical trajectory.

[0047] As will be described guide system 100 can be designed to assist with deploying an orthopedic tool. In one non-limiting example, the orthopedic tool may be a K-wire or a wire 16). As will be described, the guide body 102 may help determine or maintain the exact exit point in the other side of the extremity. In some aspects, the guide body 102 is substantially parallel with the plane defined by a brackets of a fixation device. Thus, the guide body 102 (and, thus, the guide system 100) can help the wire 16 stay in the same axial plane as the bracket, which can control against the need to redeploy of the wire 16 into the extremity.

[0048] The guide body 102 of the guide 100 extends from a first side (e.g., first end) 104 to a second side (e.g., second end) 106. In some aspects, the first side 104 and the second side 106 of the guide body 102 may be substantially identical. Thus, as will be described, either side 104, 106 can be used to define an entry point and exit point.

[0049] The guide system 100 can include at least one lumen guide 108. As illustrated, two lumen guides 108 may be included. The lumen guides 108 can be cannulated to receive a wire (not shown in FIG. 2). As will be described, though two lumen guides 108 are shown, different configurations and numbers are contemplated, from one not four or more.

[0050] The guide 100 can include a passage 110 at each of the first side 104 and second side 106. In some non-limiting examples, only the first side 104 includes a passage 110. In other nonlimiting examples, only the second side 106 includes a passage 110. The lumen guides 108 can be moveable relative to the guide body 102 through the passages 110. In particular, the lumen guides 108 can be perpendicularly moveable relative to the circular trajectory defined by the guide body 102. That is, the lumen guides 108 can extend from a proximal end 112 to a distal end 114. The proximal end 112 may include a head 115 that can be configured to assist with adjusting a position of the lumen guide 108 relative to the guide body 102 to move the distal end 114 closer 116 to or further from 118 an extremity arranged therein. Further the optional head 115 arranged at the proximal end 112 may present an enlarged entry 120 to the lumen of the lumen guide 108 to assist with positioning a wire therein to be driven toward an exit 122.

[0051] The lumen guide 108 define a through aperture (e g., an aperture that extends through the lumen guide 108) to accommodate for the wire. Said differently, the through apertures of the lumen guide 108 allow the wire to move through the lumen guide 108. The aperture through the lumen guide 108 may have a domination of, in one non-limiting example, 7.0 mm. In the illustrated configuration, the lumen guide 108 are arranged in the guide body 102 such that an exit side and an entry side (which can be defined by either of the opposingly arranged lumen guides 108 based on which side a user / doctor selects). However, as will be described, other orientations and configurations are contemplated..

[0052] Thus, the non-limiting example guide system 100 depicted in FIG. 2 includes the guide body 102, at least one lumen guide 108 (e.g., cannulated part), and at least one pin 113. The guide system 100 also includes a first side 104, second side 106, and a respective passage 110 at each of the first side 104 and second side 106. The first and second sides 104, 106 of the guide system 100 define first and second sides of the guide body 102. Thus, the first and second sides 104, 106 of the wire guide 100 will also be referred to as the first and second sides of the guide body 102. The guide body 102 defines a first plane 124 (see, e.g., FIG. 4). In some non-limiting examples, the first plane 124 is designed to be substantially horizontal relative to the fixation device 10 of FIG. 1 when the guide system 100 is engaged with the fixation device 10 of FIG. 1. In some aspects, the first plane 124 is substantially parallel to the bracket 18 of the fixation device 10 of FIG. 1. The guide body 102 also defines a second plane 126 (see, e.g., FIG. 3), that is substantially perpendicular to the first plane 124. Correspondingly, in some aspects, the second plane 126 is designed to be substantially vertical relative to the fixation device 10. In a non-limiting configuration, the first and second sides 104, 106 may be symmetrical about the second plane 126. Further, in a non-limiting example, the guide system 100 may be symmetrical about the second plane 126.

[0053] In the non-limiting example show in FIGS. 2-4, the guide body 102 is semicircular. Specifically, the guide body 102 is a half-circle. In other non-limiting examples, the guide body 102 can be a telescoping guide body, which allows the guide body 102 to extend / contract in a trajectory 128 (e.g., a radial plane) that is substantially circular. The trajectory 128 is defined by a curvature of the guide system 100. Specifically, the circular trajectory is defined by a radial curvature of the guide body 102.

[0054] Referring to FIGS. 2-44, the guide body 102 includes the at least one pin 113 on a first surface 130 (e.g., a bottom surface) of the guide body 102. The guide body 102 also includes asecond surface 132 (e ., a top surface), opposite the first surface 130. The first surface 130 is substantially parallel to the first plane 124. Further, the second surface 132 is substantially parallel to the first plane 124. In the non-limiting example shown in FIGS. 3 and 4, the guide body 102 may include two pins 113. In some aspects, the pins 113 are substantially parallel to the second plane 126. Thus, the pins 113 extend from the first surface 130 in a direction that is substantially parallel to the second plane 126. In one non-limiting example, the pins 113 extend 10.0 mm from the first surface 130. In some non-limiting examples, the pins 113 are substantially circular with a pin diameter 134 of about 6.25 mm. Further, the pins 113 are designed to be inserted into the bracket apertures 20, as discussed in greater detail below. In some aspects, the pins 113 are vertically aligned with the passage 110 of the guide body 102.

[0055] In some non-limiting examples, only the first side 104 of the guide body 102 includes at least one lumen guide 108. In other non-limiting examples, only the second side 106 of the guide body 102 includes at least one lumen guide 108. In the non-limiting example shown in FIG. 2, the at least one lumen guide 108 includes two lumen guides 108. One of the two lumen guides 108 are included at each of the first side 104 and second side 106 of the guide body 102. The lumen guides 108 may be moveable relative to the guide system 100, through the passage 110. Specifically, the lumen guides 108 are moveable relative to a direction perpendicular to the trajectory 128 of FIG. 3.

[0056] Referring now to FIGS. 5-7, the lumen guide 108 is shown in detail. As described, the lumen guides 108 include a apertures 136 (e.g., an aperture that extends through the lumen guide) to accommodate for a wire or other orthopedic tool. The apertures 136 allow the wire or other orthopedic tool move through the lumen guide 108. The lumen guide 108 includes the proximal end 112 and the distal end 114, which are on opposite ends of the lumen guide 108. The distal end 114 is inserted through the wire body 102, substantially perpendicular to the trajectory 128 and toward the extremity. Thus, the distal end 114 of the lumen guide 108 is inserted through the passage 110 perpendicular to the trajectory 128. As shown in FIG. 10, the wire 16 is inserted through the aperture 136 from the proximal end 112 to the distal end 114 before entering the extremity. Correspondingly, upon exiting the extremity, the wire 16 enters the aperture 136 of the second lumen guide from the distal end 114 and exits through the proximal end 112.

[0057] At the proximal end 112, the lumen guide 108 can also include a head 115. The head 115 includes a sloped surface 138. In the non-limiting example depicted in FIG. 7, the aperture 136 of the lumen guide 108 is centered on the sloped surface 138. Thus, the sloped surface 138 of the head115 may assist in the insertion (e.g., sliding) of a wire into the aperture 136 of the lumen guide 108. In some non-limiting examples, the head 115 may define a head diameter 140 than is larger than the passage diameter 142. In other words, the head 115 may be sized to be larger than the passage 110 and corresponding passage diameter 142. Thus, the head 115 may prevent the lumen guide 108 from being fully inserted through the guide body 102.

[0058] In some non-limiting examples, a shape of the lumen guides 108 is substantially circular. In some non-limiting examples, the lumen guides 108 include a diameter 144 that is configured to mate with the passage 110. For example, in some non-limiting configurations, the lumen guides 108 may include threads that mate with threads formed in the passage 110. In one non-limiting example, the diameter 144 may be about 6.8 mm. In some non-limiting examples, the lumen guides 108 include a length 146 that is about 55.0 mm. Further, in some non-limiting examples, the head 115 includes a length 148 that is about 5.0 mm. In some non-limiting examples, the diameter 140 is about 9.0 mm. Further still, in some non-limiting examples, the aperture 136 includes a diameter 150 that is about 2.8 mm. In some non-limiting examples, the guide body 102 is about 10.0 mm thick.

[0059] These and other dimensions may vary. For example, the guide system is designed to circumscribes at least a portion of an extremity of the patient. Thus, depending upon the extremity or needs, the dimensions may be adjusted.

[0060] Another example of a guide system 200 according to the present disclosure is shown in FIG. 8 and FIG. 9. In many aspects, the guide system 200 is similar to the guide system 100 described above and includes similar numbering. For example, the guide system 200 includes a guide body 204 that includes a first side 216 and a second side 220. The guide system 200 has at least one lumen guide 208. The at least one lumen guide 208 includes a proximal end 256, a distal end 260, and an aperture. Similar to the lumen guides 108 described above, the at least one lumen guide 208 includes two lumen guides 208. The lumen guides 108 are configured to move in a first direction 254 and a second direction 258. The guide body 204 defines a trajectory 240, a first surface 244, a second surface 248, a first plane 232, and a second plane 236, and includes slots 224. Continuing, the guide system 200 is also configured to be removably coupled (e.g., secured) to a fixation device. Thus, the above discussion of the guide system 100 applies to the guide system 200 unless otherwise specified.

[0061] In some aspects, however, the guide systems 100, 200 differ from each other. For example, the guide system 200 includes at least one arm 292. In the non-limiting configuration shown in FIGS. 8 and 9, the at least one arm 292 includes four arms 292. The arms 292 extendinward, in a direction perpendicular to the trajectory 240. Specifically, a first and second of the arms 292 are located on the first surface 244 at the first and second sides 216, 220, respectively. Further, a third and fourth of the arms 292 are radially spaced between the first and second of the arms 292 along the guide system 200 (e.g., or along the guide body 204).

[0062] The arms 292 also include the first surface 244. The arms 292 also include arm pins 296 extending from the first surface 244. In a non-limiting example, the arm pins 296 are substantially identical to the pins 113. The wire 16 can also be inserted through the lumen guides 208 of the guide system 200, as shown in FIG. 11.

[0063] Moving now to FIG. 12, a fixation system 30 is shown in a use configuration, with the guide system 100 shown removably secured to the fixation device 10. Correspondingly, the pins 113 are removably inserted to the bracket apertures 20. The lumen guides 108 are inserted in the guide body 102, with the distal end 114 of each lumen guide 108 contacting the extremity 14. Thus, as previously discussed, when a wire 16 is inserted through the lumen guides 108, the insertion angle and direction of the wire 16 and known and precise because of the guidance provided by the lumen guides 108 as the wire 16 is inserted. Further, the guide system 100 extends around a periphery of the extremity 14. In a non-limiting example, the guide system 100 may extend around the entire periphery of the extremity 14. In other non-limiting examples, the guide system 100 may extend around half or less of the periphery of the extremity 14 (e.g., a half-circle or less or more).

[0064] Similarly, as shown in FIG. 13, the guide system 200 is shown removably secured to a bracket 18 of the fixation device 10. Specifically, the arms pins 296 have been removably inserted to the bracket apertures 20. Further, the wire 16 has been inserted through the lumen guides 208 of the guide body 204. As shown in FIG. 13, the guide body 204 is radially spaced from the bracket 18, with the guide body 204 being more radially spaced away than the bracket 18 via the arms 292. Said differently, the guide body 204 is radially spaced from the bracket 18 in the second direction 258. The arms 292 advantageously allow the guide body 204 to be radially spaced from the bracket 18, which may decrease any clearance issues that occur when removably securing the guide system 200 to the bracket 18. For example, in some instances, the bracket may include additional fasteners and wires, as depicted in FIG. 1 A. Thus, the arms 292 allow the guide body 204 to be radially spaced from the bracket 18, while the arm pins 296 still allow the wire guide 200 to be removably coupled to the bracket 18.

[0065] In some implementations, devices or systems disclosed herein can be utilized or installed using methods embodying aspects of the invention. Correspondingly, description herein of particular features or capabilities of a device or system is generally intended to inherently include disclosure of a method of using such features for intended purposes and of implementing such capabilities. Similarly, express discussion of any method of using a particular device or system, unless otherwise indicated or limited, is intended to inherently include disclosure, as embodiments of the invention, of the utilized features and implemented capabilities of such device or system.

[0066] For example, a method can include installing a fixation device to an extremity, removably coupling a guide system to the fixation device, inserting a wire through the guide system, removing the guide system, and securing the wire to the fixation device. Further, inserting the wire through the guide system can include moving lumen guides in a first direction to be in contact with the extremity. Further still, removing the guide system can include moving the lumen guides in a second direction to remove the lumen guides from contacting the extremity.

[0067] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the above description or illustrated in the drawings. The systems and methods described herein are capable of other configurations and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.

[0068] Also as used herein, unless otherwise specified or limited, directional terms are presented only with regard to the particular configuration and perspective described. For example, reference to features or directions as “horizontal,” “vertical,” “front,” “rear,” “left,” “right,” and so on are generally made with reference to a particular figure or example and are not necessarily indicative of an absolute orientation or direction. However, relative directional terms for a particular configuration may generally apply to alternative orientations of that configuration. For example, “front” and “rear”directions or features (or “right” and “left” directions or features, and so on) may be generally understood to indicate relatively opposite directions or features.

[0069] As used herein in the context of activities or engagement of components, unless otherwise specified or limited, “manual” refers to the use of human hands. In some cases, “manual” engagement or activity can include direct manual engagement or activity: i.e., engagement or activity directly conducted by a user’s hands (e.g., a user grasping or manipulating an object by hand). In some cases, “manual” engagement or activity can include engagement or activity via a non-powered hand tool (e.g., pliers).

[0070] Also as used herein, unless otherwise limited or defined, “substantially parallel” indicates a direction that is within ± 12 degrees of a reference direction (e.g., within ± 6 degrees or ± 3 degrees), inclusive. Similarly, unless otherwise limited or defined, “substantially perpendicular” similarly indicates a direction that is within ± 12 degrees of perpendicular a reference direction (e.g., within ± 6 degrees or ± 3 degrees), inclusive. Correspondingly, “substantially vertical” indicates a direction that is substantially parallel to the vertical direction, as defined relative to the reference system (e.g., a local direction of gravity, by default), with a similarly derived meaning for “substantially horizontal” (relative to the horizontal direction). Discussion of directions “transverse” to a reference direction indicate directions that are not substantially parallel to the reference direction. Correspondingly, some transverse directions may be perpendicular or substantially perpendicular to the relevant reference direction.

[0071] As used herein, unless otherwise limited or specified, “substantially identical” refers to two or more components or systems that are manufactured according to the same process and specification, with variation between the components or systems that are within the limitations of acceptable tolerances for the relevant process or specification. For example, two components can be considered to be substantially identical if the components are manufactured according to the same standardized manufacturing steps, with the same materials, and within the same acceptable dimensional tolerances (e.g., as specified for a particular process or product).

[0072] The term “about,” as used herein, refers to variation in the numerical quantity that may occur, for example, through typical measuring and manufacturing procedures used for articles of footwear or other articles of manufacture that may include embodiments of the disclosure herein; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients used to make the compositions or mixtures or carry out the methods; andthe like. Throughout the disclosure, the terms “near,” “about,” and “approximately” refer to a range of values ± 15% of the numeric value that the term precedes.

[0073] As also used herein, unless otherwise defined or limited, ordinal numbers are used herein for convenience of reference based generally on the order in which particular components are presented for the relevant part of the disclosure. In this regard, for example, designations such as “first,” “second,” etc., generally indicate only the order in which the relevant component is introduced for discussion and generally do not indicate or require a particular spatial arrangement, functional or structural primacy or order.

[0074] The above discussion is presented to enable a person skilled in the art to make and use configurations of the present disclosure. Various modifications to the illustrated configurations will be readily apparent to those skilled in the art, and the generic principles herein can be applied to other configurations and applications without departing from configurations of the present disclosure. Thus, configurations of the disclosure are not intended to be limited to configurations shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected configurations and are not intended to limit the scope of configurations of the disclosure. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of configurations of the disclosure.

[0075] Thus, while the invention has been described above in connection with particular configurations and examples, the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.

Claims

CLAIMSWe claim:

1. A guide system for deploying an orthopedic tool through an extremity of a patient, the system comprising: a guide body extending in a first plane and configured to be positioned about a periphery of the extremity to arrange a first side having a first passage approximately opposite a second side having a second passage when the extremity is positioned between the first side and the second side of the guide body; a first lumen guide extending from the first passage and a second lumen guide extending from the second passage, wherein each of the first lumen guide and the second lumen guide are configured to extend in a direction perpendicular to the first plane from a proximal end engaged with the guide body to distal end proximate to the extremity when the extremity is positioned between the first side and the second side of the guide body to thereby present a trajectory for extending the orthopedic tool through the extremity from the first lumen guide, through the extremity, and to the second lumen guide; and at least one pin extending transversely from the guide body and configured to engage a reciprocal aperture in a bracket of a fixation device configured to be constructed about the extremity.

2. The system of claim 1, wherein the first lumen guide and the second lumen are configured to move through the respective first passage and second passage to adjust a position of the distal end relative to the guide body and the extremity when positioned in the guide body.

3. The system of claim 1, wherein the guide body is a configured to telescope to extend along the first plane.

4. The system of claim 1, wherein the first passage and the second passage include threads configured to engage reciprocal threads formed on the first lumen guide and the second lumen guide to adjust a position of the distal end to or from the guide body to engage the extremity when arranged within the guide body.

5. The system of claim 1, wherein the at least one pin includes two pins, wherein a first of the two pins is arranged proximate the first passage and a second of the two pins is arranged proximate to the second passage.

6. The system of claim 4, wherein the first lumen guide and the second lumen guide comprise a head formed at the proximal end that is sized to be larger than the first passage or the second passage to secure the first lumen guide and the second lumen guide within the guide body.

7. The system of claim 1 further comprising arms extending radially from the guide body to engage an extremity when arranged within the guide body.

8. The system of claim 7, wherein the arms include four arms spaced radially along the guide body.

9. A system for treating an extremity, the system including: a fixation device including a plurality of brackets, the plurality of brackets each defining a bracket plane and each including bracket apertures; a wire guide system comprising: a guide body extending in a first plane; at least one lumen guide extending through the guide body and including an entry side, an exit side, and an aperture, the aperture extending from the entry side to the exit side; and at least one pin extending from the guide body in a direction perpendicular to the first plane to engage at least one of the bracket apertures in at least one of the plurality of brackets to position the guide body to at least partially surround the extremity when the fixation device is deployed to the extremity; and wherein the at least one lumen guide is moveable through the guide body to position the exit side proximate to the extremity such that a wire being inserted in the entry side of the at least one lumen guide and extending through the exit side of the at least one lumen guide is positioned to enter the extremity at a predetermined insertion point on the extremity.

10. The system of claim 9, wherein the guide body is configured to telescope to extend along the first plane and about the extremity when positioned within the guide body.

11. The system of claim 9, wherein the at least one lumen guide includes two lumen guides arranged on opposing sides of the guide body.

12. The system of claim 11, wherein the at least one pin includes two pins, each of the two pins arranged proximate respective to one of the two lumen guides and configured to extend transversely to the first plane.

13. The system of claim 11, wherein the two lumen guides arranged on opposing sides of the guide body present a continuous passage extending therebetween to receive the wire.

14. The system of claim 13, wherein the first plane extends parallel to the bracket plane when the at least one pin is engaged with the at least one of the bracket apertures.

15. The system of claim 9 further comprising at least one arm extending in the first plane radially inward from the guide body.

16. The system of claim 15, wherein the at least one pin extends from the at least one arm.

17. A method for deploying an orthopedic tool to an extremity, the method including: constructing a fixation device about the extremity using a plurality of brackets, at least one bracket including bracket apertures; connecting a guide system to the fixation device using at least one pin extending transversely from a first plane of a guide body to be received in a bracket aperture of the at least one bracket; adjusting at least one of a first lumen guide and a second lumen guide to define a wire trajectory extending from the first lumen guide, through the extremity, and through the secondlumen guide, wherein each of the first lumen guide and a second lumen guide extend through the guide body to be arranged on opposing sides of the extremity; and pushing a wire through the first lumen guide to pass through the extremity and be received in the second lumen guide.

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