Patent ID: 12185992

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

The present disclosure describes orthopedic systems, devices, and methods for the treatment of bone fractures. More particularly, this document provides laser-guided, angle-correcting intramedullary nail systems, devices, and methods. While intramedullary nailing of a long bone of a leg is used as the context to describe the devices, systems, and methods provided herein, it should be understood that the devices, systems, and methods may also be used in various other suitable contexts. For example, devices, systems, and methods provided herein may be used for the treatment of any long bone in a body of a subject.

Referring toFIG.1, an example intramedullary nail100inserted within a bone114having a fracture102is shown. In some embodiments, the intramedullary nail100can have a length of about 50 centimeters (cm) or less (e.g., 45 cm or less, 40 cm or less, 35 cm or less, 30 cm or less, 25 cm or less, 20 cm or less). In some embodiments, the intramedullary nail100can have a diameter of about 20 millimeters (mm) or less (e.g., 15 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less). The intramedullary nail100includes an elongate shaft having a longitudinal axis Y. The intramedullary nail100includes a proximal nail component122and a distal nail component106. In some embodiments, the proximal nail component122can have a length of about 30 centimeters (cm) or less (e.g., 25 cm or less, 20 cm or less, 15 cm or less, 10 cm or less, 5 cm or less). In some embodiments, the a distal nail component106can have a length of about 30 centimeters (cm) or less (e.g., 25 cm or less, 20 cm or less, 15 cm or less, 10 cm or less, 5 cm or less). In some embodiments, the distal nail component106is curved. In some embodiments, the distal nail component106is straight. In some embodiments, the proximal nail component122and the distal nail component106are shaped like a long bone. As used to herein, the term “long bone” is defined as any of the elongated bones supporting a vertebrate limb and including an essentially cylindrical shaft that contains bone marrow and ends in enlarged heads for articulation with other bones. In some embodiments, the long bone is a humerus, a fibula, a tibia, a radius, a clavicle, or any combination thereof. The proximal nail component122defines a first coaxial channel. The distal nail component106defines a second coaxial channel. The proximal nail component122includes an outside cover112that houses the first rotatable shaft104. The proximal nail component122includes a first rotatable shaft104that is disposed within the first coaxial channel. The proximal nail component122includes an outside cover112that houses the first rotatable shaft104. The first rotatable shaft104can be a threaded shaft that engages with a threaded inner wall of the first coaxial channel. That is, the first coaxial channel can include threads that facilitate engagement of the threaded shaft. The first rotatable shaft104defines a third coaxial channel. The first coaxial channel can have a first diameter that is greater than a second diameter of the second coaxial channel.

The intramedullary nail100further includes a second rotatable shaft128. The second rotatable shaft128is disposed within the second and third coaxial channels and thus, can extend through the proximal nail component122and the distal nail component106. The second rotatable shaft128is coupled to the distal nail component106. The proximal nail component122and the distal nail component106can be connected via the second rotatable shaft128. The elongate shaft of the intramedullary nail100can be an extendable shaft. For example, the distal nail component106can be pushed distally away from the proximal nail component122, as shown by arrow116, and extended. The distal nail component106further includes one or more holes at its distal end that receive screws108. Screws108are secured onto the intramedullary nail to fixate and thereby treat the fractured bone.

Referring toFIG.2, an example intramedullary nail100inserted within a bone114having a fracture102is shown. Fracture102can be any type of bone fracture such as, but not limited to, a stable fracture, an open, compound fracture, a transverse fracture, an oblique fracture, or a comminuted fracture. In this example, the bone114is a long bone of a leg that is connected to a foot120of a subject. Furthermore, in this example, fracture102separates a proximal portion118aof the bone114and a distal portion118bof the bone114. The intramedullary nail100further includes a nail insertion handle124that can aid the user (e.g., a medical practitioner) to insert the intramedullary nail100into a bone channel within bone114. In some embodiments, the user can use a mallet to insert the intramedullary nail100into a bone channel within bone114. Screws108can be used to fix the distal nail component106to the distal portion118bof bone114.

Referring toFIG.3, the first rotatable shaft104can be configured to push distal nail component106distally away from proximal nail component122. For example, the first rotatable shaft104can be rotated using threading for creating a separation distance between a distal portion118band a proximal portion118aof bone114in preparation for subsequent adjustment of the angle of the distal nail component106with respect to the longitudinal axis Y.FIG.3shows the separation distance as d1. In some embodiments, separation distance d1can be an initial separation distance caused by the fracture of bone114. The first handle126is coupled to the first rotatable shaft104and can be used by a user to rotate the first rotatable shaft104.

FIG.4shows a final separation distance d2that can be created between a distal portion118band a proximal portion118aof bone114to facilitate angle adjustment. Thus, separation distance d2can be greater than separation distance d1. The second rotatable shaft128can be configured to adjust an angle between the distal portion118band the proximal portion118aof the bone114to restore a natural angle of the subject. In some embodiments, the angle is about 45 degrees or less (e.g., 40 degrees or less, 35 degrees or less, 30 degrees or less, 25 degrees or less, 20 degrees or less, 15 degrees or less, 10 degrees or less, 5 degrees or less, 0 degrees or less, −5 degrees or less, −10 degrees or less, −15 degrees or less, −20 degrees or less, −25 degrees or less, −30 degrees or less, −35 degrees or less, −40 degrees or less, −45 degrees or less) with respect to the longitudinal axis Y. Distal nail component104can be coupled to the second rotatable shaft128. Furthermore, the second handle130can be coupled to the second rotatable shaft128and enable a user to rotate the second rotatable shaft128. Rotation of the second rotatable shaft128leads to rotation of the distal nail component104and thus, it leads to rotation of the distal end118bof the bone114.

Referring toFIG.5, an example orthopedic system101inserted within a bone114having a fracture102is shown. The orthopedic system101can include an intramedullary nail100and a laser alignment device132. After adjusting the angle of the proximal and distal components, the distal nail component106is retracted proximally to meet and interlock with the proximal nail component122. Interlocking of the proximal and distal end components enables the intramedullary nail to maintain the desirable angle thereby, providing stabilization and weight-bearing support for the bone. The laser alignment device132can be mounted on the nail insertion handle124for guiding angle adjustment. In some embodiments, the mounting component can be retrofitted onto any of the handles. In some embodiments, the laser alignment device132can be reversibly mounted onto any of the handles.

Referring toFIG.6, the disclosure provides a top and bottom two component intramedullary nail100(e.g., a proximal and distal nail components122and106, respectively) The intramedullary nail100can be inserted into a fractured long bone and fixed at the distal end with screws through the bone. The intramedullary nail100includes a first internal rotating mechanism (e.g., the first rotatable shaft104) that can be used to push the distal nail component106, along with the distal portion118bof the bone (which moves freely due to the fracture), and internally “open” the fracture site. A laser alignment device can be mounted to the nail-insertion handle and can act as a guide for positioning the foot in line with the tibia plateau, for example. The intramedullary nail100includes a second internal rotating mechanism (e.g., the second rotatable shaft128) that can be used to directly fine adjust the angle of the distal limb to the normal physiological angle. The intramedullary nail100is designed in such way that the distal nail component106can move independently from the proximal nail component122and the angle can be adjusted with precision using a special tool inserted into the intramedullary nail100. Once the perfect angle is determined, the angle is locked using a tapered lock136and the steps are done in reverse (e.g., the distal nail component106is retracted proximally). Thus, the intramedullary nail100and with it the fracture is “closed” by retracting the distal part of the nail, keeping the angle secure and locked. At this point, the outer shell112interlocks between the proximal and distal nail components122and106, respectively, making the intramedullary nail100stable and allowing the fractured bone to bear weight. Finally, a cap is placed on the fully retracted nail to lock all components and avoid unintended rotation.

While a number of examples have been described for illustration purposes, the foregoing description is not intended to limit the scope of the invention, which is defined by the scope of the appended claims. There are and will be other examples and modifications within the scope of the following claims.