Intramedullary nail for orthopedics

Abstract

An intramedullary ("IM") nail for internal fixation of a bone is disclosed. In one embodiment, the IM nail can be a retrograde femoral nail. Alternatively, in another embodiment, the IM nail can be a tibial IM nail. In one or more embodiments, the screw hole arrangement and configuration is optimized for placement of one or more screws, fasteners, etc. Additionally, and / or alternatively, the IM nail can be arranged and configured to facilitate removal of a broken screw.

Description

[0001] Cross-reference to related applications

[0002] This is a non-provisional application filed on May 6, 2020, entitled “Orthopedic Intramedullary Nails”, U.S. Provisional Patent Application No. 63 / 020,804, and claims the benefit of the filing date thereof, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to orthopedic implants (e.g., intramedullary (“IM”) nails) for stabilizing bone, bone fragments, bone, etc. in one or more patients, and more specifically, to IM nails arranged and configured to enhance screw positioning and / or removal. Background Technology

[0004] Orthopedic fixation devices (implants) can be used for purposes such as stabilizing injuries, supporting fractures, fusing joints, and / or correcting deformities. Orthopedic fixation devices can be permanently or temporarily attached and can be attached to bone in various locations, including within a tube or other cavity of bone, under soft tissue and attached to the outer surface of bone, or placed externally and attached by fasteners such as screws, pins, and / or sutures. Some orthopedic fixation devices allow the position and / or orientation of two or more bone plates or bones to be adjusted relative to each other. Orthopedic fixation devices are typically machined or molded from isotropic materials, such as metals, including, for example, titanium, titanium alloys, stainless steel, cobalt-chromium alloys, and tantalum.

[0005] Intramedullary (“IM”) nails are a type of orthopedic fixation device. The primary function of an IM nail is to stabilize fracture fragments, thereby achieving load transfer throughout the fracture site while maintaining anatomical alignment of the bone. Currently, a wide variety of commercially available IM nails are available on the market.

[0006] One known type of IM nail is the retrograde femoral nail. The retrograde femoral nail is positioned and configured to be inserted into the femoral medullary canal of a patient through the distal end of the femur (e.g., the patient's knee). In use, the retrograde femoral nail may extend proximally from the patient's knee to the proximal portion of the patient's femur (e.g., adjacent to or near the greater trochanter).

[0007] One known drawback of retrograde femoral nails is that placing or aiming screws or fasteners (the terms are used interchangeably in this document without limitation) in the medial-lateral direction at the proximal portion of the nail becomes difficult or impossible (e.g., a standard fluoroscopy machine for aiming fastener placement would not fit the upper thigh of a patient). Therefore, retrograde femoral nails lack screw openings, holes, slots, etc., in the medial-lateral direction at their proximal portion.

[0008] Another drawback of known retrograde femoral screws is that the screw holes formed in the distal portion of the screw may not be properly aligned in situ to secure certain bone fragments relative to the screw. Furthermore, and / or alternatively, known retrograde femoral screws lack the ability to compress. For example, known retrograde femoral screws include first, second, and third screw holes or openings in their distal portion and do not include elongated slots arranged and configured to lock in compression.

[0009] Another known type of IM nail is the tibial IM nail. Tibial IM nails are positioned and configured for insertion into the medullary canal of the patient's tibia. In use, fixation of the distal portion of the tibial IM nail should avoid anatomical structures such as nerves, blood vessels, and tendons. To achieve this, known tibial IM nails contain a single distal hole formed in the distal portion, extending in the anteroposterior direction. Furthermore, the distal portion of the tibial IM nail may include two oblique holes. In use, these oblique holes may extend in different radial directions and form different angles with each other.

[0010] One concern with existing tibial IM nails is that their distal portions are not positioned and configured to provide increased fixation while avoiding anatomical structures. In other words, it would be beneficial for the distal portion of the tibial IM nail to include screw holes arranged and configured to allow the screw to protrude along a trajectory unlikely to interact with anatomical structures such as nerves, blood vessels, and tendons.

[0011] Furthermore, the proximal portion of the tibial IM nail includes a hole arranged and configured such that the proximal screw in the proximal portion is typically positioned in a hole perpendicular to the central longitudinal axis of the proximal portion of the tibial IM nail. However, in use, because the central longitudinal axis of the proximal portion of the tibial IM nail is not necessarily positioned perpendicular to the tibial plateau in the tibia, the proximal screw may not be parallel to the tibial plateau, and may even penetrate the tibial plateau. Screws not being parallel to the tibial plateau are undesirable, and penetration of the tibial plateau is unacceptable.

[0012] One known solution to ensure the proximal screw is inserted approximately parallel to the tibial plateau is to include a supplementary component in the proximal portion of the tibial IM screw to achieve a position where the proximal fastener is approximately parallel to the tibial plateau. However, this requires additional instruments, methodological steps, and time to position the screw and then attach the supplementary component to it.

[0013] Therefore, there remains a need for improved orthopedic IM nails for internal fixation of bone. This invention addresses this need and provides additional benefits and advantages in a novel and unobtrusive manner. Summary of the Invention

[0014] This summary is provided to introduce, in a simplified form, a series of concepts that will be further described in the detailed description section below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0015] In one embodiment, a retrograde intramedullary femoral nail is disclosed. In use, the retrograde intramedullary femoral nail is positioned and configured for implantation into a patient's femur via the distal end of the femur. The retrograde intramedullary femoral nail includes a body comprising an anterior proximal portion and a distal portion opposite the anterior proximal portion. The anterior proximal portion includes a plurality of anterior and posterior screw holes or openings positioned and configured to receive screws or fasteners in situ in the anteroposterior direction. Furthermore, the anterior proximal portion includes medial-lateral screw holes or openings positioned and configured to receive screws or fasteners in situ in the medial-lateral direction, such that the medial-lateral screw holes or openings are arranged perpendicular to the plurality of anterior and posterior screw holes or openings.

[0016] In one embodiment, the inner-outer screw hole or opening is in the form of an elongated slot.

[0017] In one embodiment, the proximal portion includes first and second front and rear screw holes or openings extending in the truncation direction for receiving first and second screws or fasteners, respectively. An inner-outer elongated screw groove located between the first and second front and rear screw holes or openings extends in the truncation direction.

[0018] In one embodiment, the retrograde intramedullary femoral nail is positioned within a system or kit equipped with an aiming system (e.g., an electromagnetic field tracking system). For example, the retrograde intramedullary femoral nail may be equipped with the SureShot aiming system, manufactured and sold by Smith Nephew. In use, the SureShot aiming system is a computer-based software system that provides perfect circular aiming to offer continuous, real-time visual feedback on the drill bit position, thereby ensuring correct orientation and angle. Using the SureShot aiming system, fluoroscopy is not required when aiming at medial-lateral screw openings, holes, or slots.

[0019] In one embodiment, a retrograde intramedullary femoral nail is implanted distally or at the knee into the medullary canal of the patient's femur. Once correctly implanted, one or more screws or fasteners can be inserted into the proximal portion of the retrograde intramedullary femoral nail using a SureShot aiming system. In one embodiment, the screws or fasteners can be positioned and inserted into medial-lateral grooves formed in the proximal portion of the retrograde intramedullary femoral nail. Additionally, and / or alternatively, one or more screws or fasteners can be inserted into anterior or posterior openings, holes, or grooves formed in the proximal portion of the retrograde intramedullary femoral nail.

[0020] In one embodiment, a retrograde femoral nail is disclosed. The retrograde femoral nail is arranged and configured for implantation into a patient's femur via the distal end of the femur. The retrograde intramedullary femoral nail includes a body comprising an anterior proximal portion and a distal portion opposite the anterior proximal portion. The distal portion includes a plurality of screw holes or openings arranged and configured to receive a screw or fastener. In one embodiment, the distal portion of the retrograde femoral nail includes first, second, third, and fourth holes or openings, each of which is arranged and configured to receive a screw or fastener.

[0021] In one embodiment, the first screw hole or opening (e.g., the screw hole or opening most closely positioned distal to the retrograde femoral screw) extends in situ in a generally medial-lateral direction. Meanwhile, in one embodiment, the second, third, and fourth holes or openings are angled or inclined relative to the first screw hole or opening. In one embodiment, the second, third, and fourth holes or openings are angled relative to the medial-lateral plane between about ±15 degrees and about ±45 degrees. Alternatively, in one embodiment, the fourth hole or opening may be generally parallel to the first screw hole or opening and thus extend in situ in a generally medial-lateral direction. The second and third holes or openings are angled or inclined and may be angled relative to the medial-lateral plane between about ±15 degrees and about ±45 degrees.

[0022] In one embodiment, one or both of the second and third screw holes or openings are elongated slots. In use, the reduction device can be used in conjunction with one or more elongated slots to compress a fracture in the patient's bone.

[0023] In one embodiment, a tibial IM nail is disclosed. The tibial IM nail is disposed and configured for implantation into the medullary canal of a patient's tibia. The tibial IM nail includes a body comprising an anterior distal portion and a proximal portion opposite the anterior distal portion. In one embodiment, the distal portion includes a plurality of screw openings, holes, slots, etc., disposed and configured to receive a screw or fastener. In one embodiment, the distal portion of the tibial IM nail includes first, second, third, and fourth screw holes or openings. The second and third screw holes or openings may be disposed and configured to extend at an oblique angle relative to the medial-lateral plane.

[0024] In one embodiment, the first and fourth screw holes or openings extend generally in an inside-out direction. Consequently, the second and third screw holes or openings are arranged and constructed at an angle relative to the first and fourth screw holes or openings.

[0025] In one embodiment, the second and third screw holes or openings are arranged and constructed at an angle α between approximately ±30 and ±60 degrees.

[0026] In one embodiment, the second and third angled screw holes or openings are also angled (e.g., vertically angled). That is, the second and third screw holes or openings are vertically angled relative to the central longitudinal axis of the body, such that screws or fasteners passing through the second and third screw holes or openings extend through the body at a vertical angle.

[0027] In one embodiment, a tibial IM nail is disclosed. The tibial IM nail includes a body comprising an anterior distal portion and a proximal portion opposite the anterior distal portion. The proximal portion includes a plurality of screw openings, holes, or slots, each of which is arranged and configured to receive a screw or fastener. In one embodiment, a first proximal screw opening is arranged and configured to align a screw or fastener such that a screw or fastener passing through the first or proximal screw opening does not penetrate the patient's tibial plateau (TP), through which the tibial IM nail is inserted. That is, in one embodiment, the first or proximal screw opening formed in the proximal portion of the tibial IM nail is inclined downward or angled away from the proximal end of the tibial IM nail, such that a screw or fastener inserted therein does not penetrate the tibial plateau (TP) (e.g., the first proximal screw opening includes a longitudinal central axis that is horizontally angled downward relative to the longitudinal central axis of the body, such that the first proximal screw opening is angled downward away from the proximal portion). In one embodiment, the screw or fastener may be positioned substantially parallel to the tibial plateau (TP).

[0028] In one embodiment, the first or nearest side screw hole or opening is angled or tilted downwards at approximately 5 to 10 degrees.

[0029] In one embodiment, the first or nearest side screw hole or opening is angled or tilted downwards at approximately 5 degrees.

[0030] In one embodiment, the first or nearest side screw hole or opening is angled or tilted downwards at approximately 7 to 10 degrees.

[0031] In one embodiment, the proximal portion of the tibial IM nail includes additional screw holes or openings, including, for example, second, third, and fourth screw holes or openings. In one embodiment, the second screw hole or opening from the proximal end of the tibial IM nail is also inclined or angled. In one embodiment, the second screw hole or opening includes a downward inclination or angle. In another embodiment, the second screw hole or opening includes an upward inclination or angle.

[0032] In one embodiment, the third screw hole or opening from the proximal end of the tibial IM nail is in the form of an elongated slot.

[0033] In one embodiment, an IM pin is disclosed. The IM pin includes a body comprising a distal portion, a proximal portion opposite to the distal portion, and a screw hole or opening extending through a first wall and a second wall of the IM pin. The screw hole portion extending through the first wall is threaded, and the screw hole portion extending through the second wall is unthreaded (e.g., unthreaded). That is, the screw hole extends through the first wall and the second wall of the body, defining a proximal screw hole portion through the first wall and a distal screw hole portion through the second wall, the proximal screw hole portion being threaded and the distal screw hole portion being unthreaded.

[0034] In one embodiment, the screw hole portion formed in the second wall includes a diameter D2 that is larger than the diameter D1 of the threaded portion of the locking screw, such that the threaded portion of the screw can pass through the screw hole portion formed in the second wall. That is, the proximal screw hole portion includes a diameter D1, and the distal screw hole portion includes a diameter D2 that is larger than the diameter D1. Alternatively, in one embodiment, the diameter D2 may be equal to the diameter D1.

[0035] The embodiments of this disclosure offer numerous advantages. For example, by incorporating one or more features of this disclosure, the proximal end of the retrograde femoral nail can be fixed in the medial-lateral direction (in situ) to provide better fixation, the distal end of the retrograde femoral nail can be provided with additional oblique screw holes capable of engaging potentially more fracture fragments, the distal end of the tibial IM nail can include additional screw holes arranged and configured to avoid anatomical structures, and the proximal end of the tibial IM nail can be arranged and configured to avoid penetration of the tibial plateau. Furthermore, according to another feature of this disclosure, the screw holes can be arranged and configured to facilitate easier removal of the distal portion of a broken locking screw. For example, the screw holes can be arranged and configured so that the distal portion of the broken screw can be removed through the screw holes.

[0036] The following describes in detail, with reference to the accompanying drawings, at least some of the additional features and advantages of embodiments of the invention, as well as the structure and operation of various embodiments of the invention. Attached Figure Description

[0037] The specific embodiments of the disclosed apparatus will now be described by way of example with reference to the accompanying drawings, in which:

[0038] Figure 1 This is a perspective view of an embodiment of a retrograde femoral intramedullary (“IM”) nail according to one or more features of this disclosure;

[0039] Figure 2 yes Figure 1 An alternative perspective view of the retrograde femoral IM nail shown;

[0040] Figure 3 yes Figure 1 The side view of the retrograde femoral IM nail shown;

[0041] Figure 4 yes Figure 1 An alternative side view of the retrograde femoral IM nail shown;

[0042] Figure 5 yes Figure 1 Detailed view of the proximal portion of the retrograde femoral IM nail shown;

[0043] Figure 6 yes Figure 1 Detailed view of the distal portion of the retrograde femoral IM nail shown;

[0044] Figure 7 This is a perspective view of an embodiment of a tibial IM nail according to one or more features of this disclosure;

[0045] Figure 8 yes Figure 7 The side view of the tibial IM nail shown;

[0046] Figure 9 yes Figure 7 An alternative side view of the tibial IM nail shown;

[0047] Figure 10A yes Figure 7 Detailed view of the distal portion of the tibial IM nail shown;

[0048] Figure 10B yes Figure 7 Alternate detailed view of the distal portion of the tibial IM nail shown;

[0049] Figure 11A yes Figure 7 Detailed view of the proximal portion of the tibial IM nail shown;

[0050] Figure 11B yes Figure 7 Alternate detailed view of the proximal portion of the tibial IM nail shown; and

[0051] Figure 12 It is a cross-sectional view of a screw hole formed in an IM nail according to one or more features of this disclosure.

[0052] It should be understood that the accompanying drawings are not necessarily drawn to scale, and the disclosed embodiments are sometimes shown as schematic diagrams and partial views. In some cases, details that are not necessary for understanding the disclosed methods and apparatus or that make other details difficult to understand may be omitted. It should be further understood that this disclosure is not limited to the specific embodiments shown herein. In the drawings, unless otherwise stated, the same numbers refer to the same elements. Detailed Implementation

[0053] Various features of IM pins will now be described more fully herein with reference to the accompanying drawings, in which one or more features of IM pins will be shown and described. It should be understood that various features, etc., can be used independently or in combination with each other. It should be recognized that the IM pins disclosed herein can be implemented in many different forms and should not be construed as limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will convey certain features of IM pins to those skilled in the art.

[0054] This document discloses various IM nails, which include one or more features arranged and configured to optimize the placement of one or more screws, fasteners, etc. (the terms are used interchangeably herein without limitation). Furthermore, and / or alternatively, this document discloses an IM nail that includes one or more features arranged and configured to facilitate the removal of a broken screw.

[0055] Reference Figure 1-4 An embodiment of a retrograde IM nail 100 according to one or more features of this disclosure is shown. In use, as previously described, the retrograde IM nail 100 is arranged and configured to be implanted into the femoral medullary canal of a patient via the distal femur (e.g., via the patient's knee). Thus, the retrograde IM nail 100 may also be referred to as a retrograde femoral nail.

[0056] As shown in the figure, the retrograde femoral nail 100 includes a body 102, for example, a hollow body. The body 102 includes an anterior or proximal portion 110 (anterior proximal portion) and a distal portion 130. (See reference...) Figure 1-5 According to one or more features of this disclosure, the proximal portion 110 includes a plurality of screw openings, holes, slots, etc. 112 arranged and configured to receive fasteners, screws, etc. (the terms are used interchangeably herein without limitation) in situ in a front-rear direction. In one embodiment, the screw openings, holes, slots, etc. may be threaded. Alternatively, the screw openings, holes, slots, etc. may be unthreaded, or have any other configuration now known or developed hereafter. As shown, in one embodiment, the proximal portion 110 includes first and second screw holes 112, but may contain more or fewer screw holes.

[0057] Furthermore, as shown in the figure, the proximal portion 110 of the retrograde femoral nail 100 includes screw openings, holes, slots, etc., 114 arranged and configured to receive screws in situ in the medial-lateral direction. This arrangement allows the medial-lateral screw holes or slots 114 to extend in a direction substantially perpendicular to the first and second screw holes 112. In one embodiment, the medial-lateral screw holes 114 are in the form of slots. By utilizing slots, the retrograde femoral nail 100 can be dynamically or micro-moved in situ.

[0058] Alternatively, and / or further, in one embodiment, the medial-lateral groove 114 may be used to enable the surgeon to position the fastener into the femoral neck and head of the patient's femur. In one embodiment, the retrograde femoral screw 100 has a length sufficient to extend into the patient's femur to aim at the femoral neck and head region. The medial-lateral groove 114 may have a larger size or height to improve the positioning and / or angle of the fastener into the femoral neck and head. Furthermore, in one embodiment, the medial-lateral screw hole or groove 114 may not be perpendicular to the first and second screw holes 112. This arrangement allows the medial-lateral screw hole or groove 114 to be positioned and configured to have some anterior tilt. In this embodiment, the medial-lateral groove 114 may be positioned as close as possible to the proximal anterior edge (e.g., the medial-lateral groove 114 may take the position of the first screw hole 112). This arrangement, by positioning the medial-lateral groove 114 adjacent to the proximal anterior edge, provides enhanced neck aiming. Furthermore, and / or alternatively, it is envisioned that the retrograde femoral nail 100 may also include a second groove (e.g., one or more of the screw holes 112 may be converted into a groove). Furthermore, and / or alternatively, the groove does not need to extend entirely in the medial-lateral direction.

[0059] As shown in the figure, the proximal portion 110 of the retrograde femoral nail 100 may include first and second screw holes 112 extending in the anteroposterior direction for receiving first and second screws, respectively. In one embodiment, a medial-lateral screw hole or slot 114 may be located between the first and second screw holes 112 extending in the anteroposterior direction. Although this is only an example, it should be understood that the proximal portion 110 of the retrograde femoral nail 100 may include more or fewer screw holes extending in the anteroposterior direction and more screw holes or slots extending in the medial-lateral direction. Furthermore, the screw holes may include alternative configurations, for example, the screw holes or slots extending in the medial-lateral direction may be positioned above or below (e.g., proximal or distal) the screw holes extending in the anteroposterior direction.

[0060] As shown in the figure, in one embodiment, the first or nearest anteroposterior screw hole 112 can be positioned as close as possible to the proximal end of the retrograde femoral nail 100. For example, the first or nearest anteroposterior screw hole 112 can be positioned approximately 5 mm to 10 mm from the proximal end of the retrograde femoral nail 100. The medial-lateral screw hole or slot 114 can be positioned such that the center of the proximal end of the medial-lateral screw hole or slot 114 is at least 7 mm from the first or nearest anteroposterior screw hole 112. Furthermore, the second anteroposterior screw hole 112 can be positioned at least 7 mm from the center of the distal end of the medial-lateral screw hole or slot 114.

[0061] Alternatively, and / or additionally, in one embodiment, the medial-lateral screw hole or slot 114 may be positioned approximately 25 mm proximal to the retrograde screw 100, and the third screw hole may be positioned approximately 35 mm proximal to the retrograde femoral screw 100; however, these dimensions are merely examples and other dimensions may be used. Preferably, in one embodiment, the first, second, and third screw holes 112, 114 are positioned as close as possible while maintaining the structural integrity of the retrograde femoral screw 100. In one embodiment, the first, second, and third screw holes 112, 114 are positioned within 40 mm extending from the anterior proximal end of the retrograde femoral screw 100.

[0062] Improved fixation of the proximal portion 110 of the retrograde femoral nail 100 can be achieved by providing medial-lateral screw openings, holes, or slots 114 in the proximal portion 110. Furthermore, and / or alternatively, providing one or more medial-lateral screw openings, holes, or slots 114 in the proximal portion 110 of the retrograde femoral nail 100 facilitates easier connection to the bone plate via screws, for example, those passing through the bone plate and through the medial-lateral screw openings, holes, or slots.

[0063] In use, the medial-lateral screw opening, hole, or slot 114 can be aimed (e.g., positioned) using an aiming device, for example, that includes a low-profile medial component. For example, the electromagnetic field tracking capability of the SureShot aiming system, manufactured and sold by Smith Nephew, can be used to aim the medial-lateral screw opening, hole, or slot 114. Alternatively, in an alternative embodiment, it is conceivable that the medial-lateral screw opening, hole, or slot 114 formed in the proximal portion 110 of the retrograde femoral nail 100 can be aimed using an instrument that rotates from one or both of the screw holes 112 extending in the anteroposterior direction.

[0064] In use, the SureShot aiming system is a computer-based software system that provides perfect circular aiming and continuous, real-time visual feedback on drill position to ensure correct orientation and angle. Using the SureShot aiming system, fluoroscopy is not required during aiming of the medial-lateral screw opening, hole, or groove 114 of the retrograde femoral nail 100. Due to the SureShot aiming system's uniquely slender operation, the limitation of placing a fluoroscopic device medial to the retrograde femoral nail 100 (e.g., in the patient's lower groin area) is overcome.

[0065] In one embodiment, the SureShot aiming system in use includes a field generator for generating one or more magnetic fields, a movable probe having a first magnetic sensor, a landmark identifier, and a processor. The landmark identifier may include a second sensor, or alternatively, include the field generator. The processor may utilize sensor data, and if desired, the field generator and other information, preferably in six degrees of freedom, to generate and display the position and orientation of the sensors(s), thereby generating and displaying the position and orientation of landmarks (e.g., screw holes) formed in an orthopedic implant (e.g., a retrograde femoral nail) located in the magnetic field. This system allows for blind aiming at one or more landmarks. Further information regarding the SureShot aiming system can be found in U.S. Patent No. 8,623,023, filed February 18, 2011, entitled “Targeting an Orthopaedic Implant Landmark,” the entire disclosure of which is incorporated herein by reference.

[0066] In one embodiment, a retrograde femoral nail 100 may be disposed in a system. The system may include one or more retrograde femoral nails 100, each comprising a medial-lateral screw opening, hole, or groove 114 formed in its proximal portion 110. The system may also include a SureShot aiming system for identifying and placing screws through the medial-lateral opening, hole, or groove 114. For example, in one embodiment, the retrograde femoral nail 100 may be implanted into the femoral medullary canal of a patient via a distal or knee approach. Once correctly implanted, one or more screws may be inserted into the proximal portion 110 of the retrograde femoral nail 100 using the SureShot aiming system. For example, screws may be positioned and inserted into the medial-lateral groove 114 formed in the proximal portion 110 of the retrograde femoral nail 100. Furthermore, and / or alternatively, one or more screws may be inserted into anterior or posterior openings, holes, or grooves 112 formed in the proximal portion 110 of the retrograde femoral nail 100.

[0067] Reference Figure 1-4 and Figure 6 According to what can be combined with the above text Figure 5 The novel proximal portion 110 of the discussed retrograde femoral nail 100, used separately or in combination with one or more features of this disclosure, includes a plurality of screw openings, holes, slots, etc. 132 arranged and configured to receive a screw. As shown, the distal portion 130 of the retrograde femoral nail 100 includes first, second, third, and fourth holes 132A, 132B, 132C, and 132D.

[0068] In one embodiment, the first hole 132A can be positioned approximately 10 mm from the distal end of the retrograde femoral nail 100, the second hole 132B can be positioned approximately 20 mm from the distal end, the third hole 132C can be positioned approximately 30 mm from the distal end, and the fourth hole 132D can be positioned approximately 40 mm from the distal end; however, these dimensions are merely examples and other dimensions may be used.

[0069] This arrangement allows for additional screw fixation by including an additional or fourth screw hole in the distal portion 130 of the retrograde femoral nail 100, enabling fixation to potentially more bone fragments.

[0070] In one embodiment, the first screw hole 132A (e.g., the screw hole closest to the distal end of the retrograde femoral nail 100) may extend in situ in a generally medial-lateral direction. Meanwhile, in one embodiment, the second, third, and fourth screw holes 132B, 132C, and 132D may be angled or oblique. For example, the second, third, and fourth screw holes 132B, 132C, and 132D may be at an angle of approximately ±15 degrees to approximately ±45 degrees, preferably approximately ±25 degrees, with respect to the medial-lateral plane (or relative to the first screw hole 132A), but other angles may be used. Alternatively, in one embodiment, the fourth hole 132D may be generally parallel to the first screw hole 132A, and thus extend in situ in a generally medial-lateral direction. The second and third screw holes 132B and 132C are angled or oblique. For example, the second and third screw holes 132B, 132C can be at an angle of about ±15 degrees to about ±45 degrees with the inner-outer plane (or relative to the first and fourth screw holes 132A, 132D), preferably about ±25 degrees, but other angles can be used.

[0071] Furthermore, and / or alternatively, one or more of the screw holes may be in the form of elongated slots. In one embodiment, one or more of the screw holes formed in the distal portion 130 of the retrograde femoral nail 100 may be in the form of elongated slots. For example, in one embodiment, the second and third screw holes 132B, 132C (e.g., the second and third screw holes 132B, 132C from the distal end of the retrograde femoral nail 100) may be in the form of elongated slots. This arrangement, by forming the second and third screw holes 132B, 132C as elongated slots, allows the second and third screw slots 132B, 132C to be used for compression fractures. That is, as those skilled in the art will appreciate, fracture compression can be accomplished by using a combination of slots and reduction devices. In use, the reduction device may be any reduction device now known or developed later.

[0072] In one embodiment, the reduction device includes a reducer, a bracket, and a locking device that engages with both proximal and distal bone fragments. In use, the retrograde femoral nail 100 is secured to the distal bone fragment via the locking device. The bracket engages with the retrograde femoral nail 100 through an opening (e.g., a second or third screw slot 132B, 132C). The reducer includes a compression screw that applies force to the bracket to reduce the fracture. Further information regarding the reduction can be found in U.S. Patent No. 8,628,531, filed June 25, 2008, entitled "Assemblies for the Reduction of a Fracture," the entire disclosure of which is incorporated herein by reference.

[0073] Compression of the fibular fracture in a patient's bone can be achieved by using a retrograde femoral nail with one or more slender grooves and a reduction device.

[0074] Reference Figure 7-9 An example of an embodiment of a tibial IM nail 200 according to one or more features of this disclosure is shown. In use, as previously described, the tibial IM nail is arranged and configured for implantation into the medullary canal of a patient's tibia.

[0075] like Figure 7-9 As shown, the tibial IM nail 200 includes a body 202, which includes a proximal portion 210 and a distal portion 230 (e.g., the distal portion 230 is now the anterior portion). Figure 7-10B As shown, in one embodiment, the distal portion 230 includes a plurality of screw openings, holes, slots, etc. 232 arranged and configured to receive screws. As shown, in one embodiment, the distal portion 230 of the tibial IM screw 200 includes first, second, third, and fourth holes 232A, 232B, 232C, and 232D. In use, the second and third screw holes 232B and 232C extend at an oblique angle (e.g., the second and third screw holes are angled at angle α relative to the medial-lateral plane, such as...). Figure 10B (As best shown in the figure). Thus, as shown, the distal portion 230 of the tibial IM nail 200 includes a first screw hole 232A and a fourth screw hole 232D extending generally in a medial-lateral superior direction. Subsequently, the second screw hole 232B and the third screw hole 232C can extend at an oblique angle. This arrangement allows anatomical structures to be avoided by properly orienting the construction and positioning of the second and third oblique screw holes 232B, 232C.

[0076] In one embodiment, the second and third screw holes 232B, 232C can be arranged and constructed in either direction at an angle α between approximately ±30 and ±60 degrees with respect to the inner-outer plane (e.g., rotated approximately ±30 to ±60 degrees relative to the inner-outer plane).

[0077] Furthermore, in one embodiment, the second and third oblique screw holes 232B, 232C may be tilted (e.g., vertically angled), but the second and third screw holes 232B, 232C may be positioned horizontally (e.g., parallel to the first and fourth screw holes 232A, 232D). That is, one or both of the oblique screw holes 232B, 232C may be angled relative to the central longitudinal axis of the distal portion of the tibial IM nail 200.

[0078] In one embodiment, the first or most distal screw hole 232A can be positioned approximately 6 mm distal to the tibial IM screw 200. The second oblique screw hole 232B can be positioned approximately 14 mm distal to the tibial IM screw 200. The third oblique screw hole 232C can be positioned approximately 22 mm distal to the tibial IM screw 200. The fourth medial-lateral screw hole 232D can be positioned approximately 30 mm distal to the tibial IM screw 200. However, it should be understood that such dimensions are merely examples and other dimensions may be used.

[0079] This arrangement, by optimizing the position and angle of the screw holes, achieves maximum fixation while avoiding anatomical structures such as nerves, blood vessels, and tendons.

[0080] Reference Figure 7-9 11A and 11B, according to which can be combined with the above text Figure 10A and 10B The novel distal portions discussed, used separately or in combination, include one or more features of this disclosure, such that the proximal portion 210 of the tibial IM nail 200 may be arranged and configured with a plurality of screw openings, holes, or slots 212. In one embodiment, a first or proximal hole 212A is arranged and configured such that the screw is substantially parallel to the tibial plateau TP through which the tibial IM nail 200 is inserted. That is, in one embodiment, the first or proximal screw hole 212A formed in the proximal portion 210 of the tibial IM nail 200 is arranged and configured to achieve a substantially parallel alignment of the screw with the tibial plateau TP.

[0081] As shown in the figure, in one embodiment, the first or nearest-side screw hole 212A formed in the proximal portion 210 of the tibial IM nail 200 may be inclined downwards or angled away from the proximal end of the tibial IM nail 200. That is, the first or nearest-side screw hole 212A may be angled downwards such that the screw inserted therein is positioned substantially parallel to the tibial plateau TP through which the tibial IM nail 200 is inserted. In one embodiment, the first or nearest-side screw hole 212A may be angled downwards or inclined at approximately 5 degrees. Alternatively, in an alternative embodiment, the first or nearest-side screw hole 212A may be angled downwards or inclined at approximately 7 to 10 degrees. With this arrangement, the screw inserted into the first or nearest-side screw hole 212A may include a downward slope between 5 and 10 degrees, plus or minus one degree.

[0082] In this manner, the first or nearest-side screw hole 212A is arranged and configured such that the screw or other fastener is substantially parallel to the tibial plateau TP, or at least avoids penetrating the tibial plateau TP.

[0083] Furthermore, in one embodiment, the proximal portion 210 of the tibial IM nail 200 may also include additional screw openings, holes, or slots. For example, as shown, in one embodiment, the proximal portion 210 of the tibial IM nail 200 may include second, third, and fourth screw openings, holes, or slots 212B, 212C, and 212D. In one embodiment, as... Figure 11A As best shown, the second screw hole 212B from the proximal end of the tibial IM nail 200 can also be tilted or angled. In one embodiment, the second screw hole 212B may include a downward tilt or an angle. Alternatively, the second screw hole 212B may include an upward tilt or an angle. This arrangement, with the second screw hole 212B angled, facilitates increased bone fixation in the cortical bone (e.g., increased bone fixation can be achieved by increasing the screw length while avoiding penetration of the tibial plateau TP).

[0084] Furthermore, and / or alternatively, according to one or more features of this disclosure, as shown in the figure, the third screw hole 212C from the proximal end of the tibial IM nail 200 may be in the form of an elongated slot. This arrangement allows for compression at the proximal portion 210 of the tibial IM nail 200 during use. Furthermore, and / or alternatively, the second screw hole 212B from the proximal end of the tibial IM nail 200 may be in the form of an elongated slot, such that the second screw hole 212B can be used to achieve compression.

[0085] This arrangement, according to one or more features of this disclosure, reduces the likelihood of the first or nearest-side screw penetrating the tibial plateau TP by tilting or angulating the first or nearest-side screw hole 212A downwards. This also facilitates allowing the first or nearest-side screw to avoid penetrating the tibial plateau TP without requiring additional components to be added to the proximal portion 210 of the tibial IM nail 200 to achieve the desired angulation. Furthermore, this orientation improves cortical bone grip without altering the basic structure of the nail and instrumentation requirements. Maintaining the ability to compress proximal fragments using conventional techniques is also advantageous (e.g., including one or more grooves to maintain the ability to compress the proximal portion 210 of the tibial IM nail 200). Additionally, the tibial IM nail 200 avoids the need for significant changes to the nail instrumentation or insertion method.

[0086] Reference Figure 12 In conjunction with another feature of this disclosure, which may be used alone or in combination with other features described herein, a detailed cross-sectional view of the screw hole of an IM nail (e.g., a retrograde femoral nail 100, a tibial IM nail 200, or any other IM nail now known or developed hereafter) is shown. In use, the IM nail 300 includes a body 302 (e.g., a hollow body) comprising screw holes 310 arranged and configured to facilitate easier removal of the distal portion of a broken locking screw.

[0087] Those skilled in the art will appreciate that inserting a screw through a screw hole formed in a hollow IM nail requires the screw to pass through a first or proximal screw hole portion formed in the first or proximal wall of the IM nail and through a second or distal screw hole portion formed in the second or distal wall of the IM nail (e.g., proximal and distal refer to the trajectory of the screw path). In use, when the IM nail is subjected to load or during the insertion of the screw through the IM nail into the patient's bone, the locking screw inserted into the threaded screw hole formed in the IM nail may break. However, if the screw is arranged and configured to engage the threads formed in the first or proximal screw hole portion formed in the first or proximal wall and the second or distal screw hole portion formed in the second or distal wall, as is the case with known IM nails, it is difficult to remove the distal portion of the broken locking screw. That is, in use, the locking screw is arranged and configured to thread into the first and second walls of the IM nail, so that the screw is threaded into the first or proximal screw hole portion and the second or distal screw hole portion. If a screw breaks off on the distal side of the first or proximal threaded screw hole portion, as is usually the case, it is difficult to remove the distal portion of the broken screw because the distal portion is still threaded to the second or proximal threaded screw hole portion and separates from the screw head. Therefore, rotating the screw head will not remove the distal portion of the broken screw.

[0088] Currently, one method for removing the broken distal portion of a broken screw from a patient involves tissue removal and grasping and rotating the distal portion of the screw (e.g., a second incision may be made on the opposite side of the patient's leg to grasp and rotate the distal portion of the broken screw, disengaging it from the second or distal threaded screw hole portion formed in the second or distal wall of the IM nail). Alternatively, a hole may be drilled in the distal portion of the broken screw (e.g., the distal portion of the screw contacts a portion of the IM nail). In either case, each of these solutions is problematic because it has the potential to cause undesirable tissue damage and introduce unwanted debris into the surgical site.

[0089] Therefore, providing a more practical solution would be beneficial. For example, it is advantageous to simply use a punch or similar tool to drive out the distal portion of the broken screw through the first or proximal hole portion formed in the first or proximal wall of the IM nail, leaving the proximal portion of the broken screw. The proximal portion of the broken screw can be unscrewed. However, this is not possible when the distal portion of the screw is still threadedly connected to the threads in the second or distal screw hole portion formed in the second or distal wall of the IM nail (e.g., when the screw breaks distal to the first or proximal screw hole portion formed in the IM nail, the distal portion of the broken screw is still threadedly connected to the second or distal screw hole portion formed in the IM nail). In other words, it is impractical to require a surgeon to use sufficient force to strike the proximal portion of the distal portion of the broken screw with a punch or similar tool to cut the threaded connection between the distal portion of the broken screw and the IM nail.

[0090] Reference Figure 12 In one embodiment, the IM pin includes a first or proximal sidewall 303 and a second or distal sidewall 304, and a screw hole 310 formed in the IM pin 300 passes through both the first or proximal sidewall 303 and the second or distal sidewall 304. However, according to one or more features of this disclosure, the threads 315 for engaging the locking screw are provided only along the trajectory of the locking screw in the first or proximal sidewall 303 of the IM pin 300 (e.g., the first or proximal screw hole portion 310A) (e.g., the second or distal screw hole portion 310B formed in the second or distal sidewall 304 has no threads). With this arrangement, if the screw breaks distally beyond the thread 315 formed in the first or proximal screw hole portion 310A formed in the first or proximal wall 303 of the IM nail 300, the distal portion of the broken screw can be driven out of the patient along the screw's trajectory or path, and only the gripping of the distal portion of the broken screw with the tissue into which the screw was implanted needs to be overcome, rather than the thread gripping between the distal portion of the broken screw and the second or distal screw hole portion 310B formed in the second or distal wall 304 of the IM nail 300 into which the screw was inserted.

[0091] As shown in the figure, in one embodiment, the first or proximal wall 303 of the IM pin 300 through which the initial insertion locking screw passes is threaded (e.g., including thread 315), while the second or distal wall 304 of the IM pin 300 is unthreaded. Furthermore, the second or distal screw hole portion 310B formed in the second or distal wall 304 of the IM pin 300 preferably includes a diameter D2, which is larger than the diameter D1 of the threaded portion of the locking screw, such that the threaded portion of the screw can pass through the second or distal screw hole portion 310B formed in the second or distal wall 304 of the IM pin 300 (e.g., in…). Figure 12 In the diagram, locking screws are indicated by dashed lines for clear visualization of the IM screw. Alternatively, in one embodiment, diameter D2 can be equal to diameter D1. In one embodiment, diameter D1 can be approximately 12mm to 13mm, and diameter D2 can have a lower limit of 12mm, but these dimensions are exemplary and other dimensions may be used.

[0092] With this arrangement, if the locking screw breaks anywhere distal to the first or proximal threaded hole portion 310A formed in the first or proximal wall portion 303 of the IM nail 300, the proximal portion of the screw can be removed using the screw head (e.g., the proximal portion of the broken screw can be unscrewed from the IM nail 300). The distal portion of the broken screw can be driven distally through the tissue using a punch or other instrument adapted to the second or distal unthreaded hole portion 310B formed in the second or distal wall 304 of the IM nail 300 after the proximal portion of the broken screw has been removed. In this way, the screw threads engage only with the tissue (rather than anywhere on the IM nail 300) and gripping within the tissue can be easily overcome.

[0093] Furthermore, the extractor, including a perforated saw cutter, can be advanced from the distal end of the broken screw to core the tissue plug around the cross-section of the broken screw, thereby facilitating screw removal. In the proposed method, the perforated saw cutter does not need to cut any implant material, only the tissue.

[0094] In an alternative embodiment, the distal portion of the screw may also be unthreaded. For example, the distal portion of the screw (e.g., the shaft portion) may be in the form of a pin. This arrangement allows for easier removal of the distal portion of a broken locking screw.

[0095] In either case, by arranging the second or distal wall 304 of the IM nail 300 with a threadless screw hole portion 310B, easier removal of the distal portion of the broken locking screw can be achieved, thereby reducing tissue damage and eliminating or at least reducing debris inadvertently introduced into the surgical site.

[0096] The foregoing description has broad applicability. Therefore, the discussion of any embodiment is merely illustrative and is not intended to imply that the scope of this disclosure (including the claims) is limited to these exemplary embodiments. In other words, while illustrative embodiments of this disclosure have been described in detail herein, it should be understood that the inventive concept can be practiced and used in other ways, and the appended claims are intended to be interpreted as including such variations, unless limited by prior art.

[0097] As used herein, the term “a” or “an” entity refers to one or more of the entity. Therefore, the terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein. As used herein, “comprising,” “including,” or “having,” and variations thereof, means including items listed herein and their equivalents, as well as other items. Therefore, the terms “comprising,” “including,” or “having,” and variations thereof, are open-ended expressions and are used interchangeably herein. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that combine and separate in operation.

[0098] All directional references (e.g., proximal, distal, upper, lower, down, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are used for identification purposes only to aid the reader's understanding of this disclosure and do not constitute limitation, particularly regarding the location, orientation, or use of this disclosure. Unless otherwise stated, connection references (e.g., attachment, link, connection, and engagement) should be interpreted broadly and may include intermediate members between sets of elements and intermediate members that move relatively between elements. Thus, a connection reference does not necessarily infer that two elements are directly connected and have a fixed relationship with each other. Identification references (e.g., first, second, first, third, fourth, etc.) are not intended to imply importance or priority but are used to distinguish one feature from another. The accompanying drawings are for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the accompanying drawings may vary.

Claims

1. A retrograde intramedullary femoral nail, said retrograde intramedullary femoral nail being disposed and configured for implantation into a patient's femur via the distal end of the femur, said retrograde intramedullary femoral nail comprising: The body includes a proximal portion and a distal portion opposite the proximal portion, the distal portion including a first screw hole, a second screw hole, a third screw hole, and a fourth screw hole, each of the first screw hole, the second screw hole, the third screw hole, and the fourth screw hole being arranged and configured to receive a fastener; At least one of the first screw hole, second screw hole, third screw hole and fourth screw hole extends through the first wall (303) and the second wall (304) of the body, the at least one screw hole defining a proximal screw hole portion (310A) through the first wall (303) and a distal screw hole portion (310B) through the second wall (304), the proximal screw hole portion (310A) including threads and the distal screw hole portion (310B) not having threads.

2. The retrograde intramedullary femoral nail according to claim 1, wherein: The first screw hole is positioned closest to the distal portion of the body, and the first screw hole extends in situ in the inside-outside direction; and The second screw hole, the third screw hole, and the fourth screw hole are at an angle relative to the first screw hole.

3. The retrograde intramedullary femoral nail according to claim 2, wherein each of the second screw hole, the third screw hole and the fourth screw hole is angled relative to the medial-lateral plane between ±15 degrees and ±45 degrees.

4. The retrograde intramedullary femoral nail according to claim 2, wherein each of the second screw hole and the third screw hole is angled relative to the medial-lateral plane between ±15 degrees and ±45 degrees, and the fourth screw hole is parallel to the first screw hole.

5. The retrograde intramedullary femoral nail according to any one of claims 1-4, wherein one or both of the second screw hole and the third screw hole are elongated slots.

6. The retrograde intramedullary femoral nail according to any one of claims 1-4, wherein the first hole is positioned 10 mm from the distal portion, the second screw hole is positioned 20 mm from the distal portion, the third screw hole is positioned 30 mm from the distal portion, and the fourth screw hole is positioned 40 mm from the distal portion.

7. The retrograde intramedullary femoral nail according to any one of claims 1-4, wherein the anterior proximal portion further includes a plurality of anterior and posterior screw holes arranged and configured to receive fasteners in situ in the anterior-posterior direction, and the anterior proximal portion further includes medial-lateral screw holes arranged and configured to receive fasteners in situ in the medial-lateral direction.

8. The retrograde intramedullary femoral nail according to claim 7, wherein the medial-lateral screw holes are arranged perpendicularly to the plurality of anterior and posterior screw holes.

9. The retrograde intramedullary femoral nail according to claim 7, wherein the medial-lateral screw hole is in the form of an elongated slot.

10. The retrograde intramedullary femoral nail of claim 9, wherein the plurality of anterior and posterior screw holes include a first anterior and posterior screw hole and a second anterior and posterior screw hole for receiving a first fastener and a second fastener, respectively, and the elongated groove is located between the first anterior and posterior screw hole and the second anterior and posterior screw hole.

11. The retrograde intramedullary femoral nail according to claim 10, wherein the first anterior and posterior screw holes are positioned between 5 mm and 10 mm from the proximal end of the body, the second anterior and posterior screw holes are positioned 35 mm from the proximal end of the body, and the elongated groove is positioned 25 mm from the proximal end of the body.

12. The retrograde intramedullary femoral nail according to claim 10, wherein the first anterior and posterior screw holes are positioned between 5 mm and 10 mm from the proximal end of the body, the elongated groove is positioned approximately 7 mm from the first anterior and posterior screw holes, the second anterior and posterior screw holes are positioned approximately 7 mm from the elongated groove, and the first anterior and posterior screw holes, the elongated groove, and the second anterior and posterior screw holes are all located within a distance of 40 mm from the proximal end of the body.

13. The retrograde intramedullary femoral nail according to claim 9 further includes using an electromagnetic field tracking system to track the elongated groove during use.

14. The retrograde intramedullary femoral nail of claim 1, wherein the proximal screw hole portion includes a diameter D1, and the distal screw hole portion includes a diameter D2 that is larger than the diameter D1.

15. The retrograde intramedullary femoral nail of claim 1, wherein the proximal screw hole portion includes a diameter D1, and the distal screw hole portion includes a diameter D2 equal to the diameter D1.

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