Patent ID: 12220136

DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS

Embodiments may be implemented in hardware, firmware, software, or any combination thereof. Reaming of bones is practiced to allow the insertion of intramedullary nails. However, the process as performed in the prior art can cause complications. The embodiments shown in the exemplary methods and device are not exhaustive and other operations can be performed in addition to the illustrated processes. In some embodiments of the present disclosure, the operations may vary and/or can be performed in a different order.

Reamer Device with Visual Inspection Grooves

FIG.1illustrates a reamer device110for performing an operation to ream a bone, such as a fibula. According to some embodiments, reamer device110corresponds an intramedullary nail having one or more depth gauges to indicate an appropriate depth that has been achieved during a reaming procedure. Specifically, reamer device110includes a cutting tip112, one or more helical cutting edges114with flutes formed therebetween, and one or more grooves116(e.g., grooves116A and116B). The sharp cutting tip112bores through bone, while the helical cutting edges114can traverse the bone while corresponding to geometrical patterning of an intramedullary component. According to some embodiments, reamer device110may be a cannulated tapered reamer device. Reamer device110can be formed from stainless steel, cobalt chrome, or titanium, or other metals or alloys suitable for medical use, to name just a few non-limiting examples.

Grooves116allow for precise control over alignment and position of the reamer device110during a bone reaming procedure. Specifically, grooves116enable a user (e.g., a health care practitioner or the like) to visually confirm during the reaming step that an appropriate depth has been prepared to allow for optimal placement of syndesmotic fixation. In existing technology, there is the potential of increased intraoperative time to optimally place those fixation members. In an embodiment, syndesmotic fixation members can be placed accurately, thereby minimizing or eliminating additional intraoperative time by performing a visual check of the position of the grooves116during performance of the reaming step.

During the visual check, the user (e.g., a health care practitioner, or the like) performs a radiographical scan of the reaming to confirm the depth of the reaming that has been performed by visually sighting grooves (e.g.,116A and116B) on the cutting edges of the reamer device100. Anterior-Posterior (AP) radiographs, lateral radiographs, and the like, can be performed during the visual check to determine the depth of grooves116(and correspondence of groove depth to the site of the fracture, for example).

According to some embodiments, one or more grooves116form a depression in a radial outer surface of an associated helical cutting edge. According to some embodiments, the depression can have a depth of between zero and 1 millimeter (mm) to the helical edge. According to some embodiments, at least one of grooves116of the helical cutting edge can form a depression having a depth of 0.65 mm to 0.85 mm from the helical cutting edge. For example, at least one groove can form a depression approximately 0.75 mm deep from the helical cutting edge.

According to some embodiments, one or more grooves116may be arranged at one or more radial distances from the longitudinal axis of the cutting tip112. According to some embodiments, one or more grooves116may be arranged at a distance d from a distal end of the cutting edge, where d is a distance between 10 and 25 mm. In some embodiments, a cutting head can have grooves116spaced at a distance of approximately 10 mm from each other. In one non-limiting example, a cutting head (e.g., tip112) can include a first groove116A forming a first depression in an associated helical cutting edge114, the first depression centered approximately 12.5 mm from the distal end of the cutting head and a second groove116B forming a second depression in an associated helical cutting edge114centered approximately 22.5 mm from the distal end.

Reamer device100can include a body115at a proximal end adjacent to the one or more cutting edges114. In some embodiments, reamer device100can include a connector118formed at the proximal end of body115, wherein the connector118is constructed and arranged to be coupled to a rotary actuator (e.g., a rotary power tool having a power source, a manual rotary driver, or the like), as further described hereinbelow in relation toFIG.3. The connector118can be coupled to the rotary actuator by insertion into a chuck thereof. In some embodiments, connector118can be reduced dimensionally relative to the body to fit into the chuck of a rotary power tool. In other embodiments, connector118can be flatted or tanged to prevent slipping in the chuck.

FIG.2illustrates an intramedullary nail system200that includes a reamer device210, which may be an embodiment of reamer device110and corresponds to intramedullary nail220as described in greater detail hereinbelow. The stabilization of bone fractures can be achieved through reaming the medullary cavity using reamer device210and inserting intramedullary nail220therein. In some embodiments, the insertion of intramedullary nail220can include locking bolts (not shown). In other embodiments, locking bolts are not necessary. According to embodiments, reamer device210can minimize breakage of the interlocking screws and improve bone union at the fracture site.

As described above, reamer device210includes a cutting tip212, one or more helical cutting edges214, and one or more grooves216, such as the grooves216A and216B. According to some embodiments, reamer device210may be a cannulated tapered reamer device. As depicted inFIG.2, grooves216are formed on cutting edges214of the reamer device210, wherein the vertical lines indicate how the grooves216A and216B align with the corresponding syndesmotic fixation holes226A and226B on the intramedullary nail220. The reamer device210may be used prior to the placement of the nail, and radiographic visualization of the grooves216during the reaming process provides a visual aid to the user to identify where the user can expect the syndesmotic fixation to be placed after the intramedullary nail220is in place.

Grooves216allow for precise control over alignment and position of the reamer device210during a bone reaming procedure. As discussed above, grooves216may be aligned with a one or more syndesmotic fixation holes226of intramedullary nail210. In one non-limiting example, one or more screws may be fixed between the tibia and fibula in a syndesmotic fixation procedure to stabilize the syndesmosis until syndesmotic ligament healing can be achieved. A syndesmotic screw is a positioning screw that is used to hold the syndesmosis without compression. In some embodiments, the syndesmotic screw is positioned through a fibular plate230. The fibular plate230is positioned along a posterolateral fibular border to facilitate entry of a syndesmotic screw into a tibia.

FIG.3illustrates a reamer device210coupled to a rotary actuator320.

The body of reamer device210is inserted into a chuck of a rotary actuator320. According to some embodiments, reamer device210and/or rotary actuator320may be clasped using a clasping device325. During a procedure, a user may precisely guide reamer device210into a targeted bone utilizing clasping device325. The user may monitor radiograph images while performing the procedure and while securely clasping reamer device210. In this manner, precise control of the depth of the reaming can be performed to correspond with an arrangement of syndesmotic fixation holes in an intramedullary nail.

FIG.4Aillustrates radiographic visualization300of a reamer device110, including confirmation of depth based on a position of grooves116during reaming as described above. A user performing a surgical reaming procedure, such as a syndesmotic fixation procedure, can utilize radiographic visualization400of reamer device110to guide the procedure, including how far to insert reamer device110into the targeted bone. The user can visually confirm the depth of the reaming that has been performed utilizing the radiographical scan by visually sighting grooves (e.g.,116A and116B) on the cutting flutes of the reamer device100. Anterior-Posterior (AP) radiographs, lateral radiographs, and the like, can be performed during the visual check to determine the depth of grooves116(and correspondence of groove depth to the site of the fracture415, for example).FIG.4Billustrates the placement of a fibular plate230along a posterior border along the back of the fibula, which can be aligned with intramedullary nail230to facilitate entry of a syndesmotic screw into the tibia. For example, after insertion of intramedullary nail220, a user can fix a syndesmotic screw through the fibular plate and intramedullary nail230to the tibia utilizing fibular plate420to hold but not compress the syndesmosis.

Performing Intramedullary (IM) Fixation Using Reamer Device with Visual Inspection Grooves

FIG.5depicts a flow diagram of a method for performing a surgical procedure500to drive a reaming device to a confirmed depth, according to some embodiments.

Referring toFIG.5, surgical procedure500includes an operation505of identifying a starting point on a distal end of a fibula. For example, the starting point can be confirmed by a user of reamer device110(e.g., a health care practitioner, or the like). The starting point may be on a distal tip of the fibula in some embodiments. According to some embodiments, the starting point may be slightly medial to the most distal portion of the fibula on the AP view. On the lateral view, it is slightly anterior to the center of the fibular canal.

In some embodiments, operation505can include insertion of a guide wire from the distal tip into the intramedullary canal to preserve the lateral cortex of the fibula during reaming According to some embodiments, a guide wire having a 0.062-inch gauge can be used.

A reamer device110having a 6.2 mm length can be used. According to some embodiments, a tissue protector can be used to prevent injury while driving the reamer device. For example, a patient may be prepared for surgery, including placing the patient under general anesthesia or sedation, administering antibiotics, and placing the patient on an operating room table. A radiographic/fluoroscopic imaging device can be directed toward the site of the procedure. According to some embodiments, a guide wire can be driven into the talus. A skin incision can be made to the tip of the fibula.

According to some embodiments, distal reaming can be performed. For example, a 6.2 mm tapered reamer device can be driven over a guidewire through a tissue protector until the reamer device flutes are fully within the bone, as confirmed by visual inspection of grooves116using one or more radiographs. According to other embodiments, proximal reaming can be performed. In another non-limiting example, a 3.2 mm reamer device can be driven over the guidewire and through the tissue protector, until grooves116are well within the bone.

Procedure500continues with operation510, in which the reamer device110is driven over the guide wire to open the distal portion of the fibula (a measurement of the distal portion can vary). For example, a 6.2 mm tapered reamer device may be driven over the guidewire through the tissue protector until the reamer device flutes are fully within the bone. As described in detail above, reamer device110includes grooves116permitting the user to visually confirm the depth and alignment of reamer device110during a bone reaming procedure.

At operation515, the user can visually confirm, using radiograph images, the position of grooves116within the fibula, verifying that an appropriate depth has been prepared to allow for optimal placement of syndesmotic fixation. In existing technology, there is the potential of increased intraoperative time to optimally place those fixation members. In an embodiment, syndesmotic fixation members can be placed accurately, thereby minimizing or eliminating intraoperative time by performing one or more visual checks during performance of the reaming step.

For example, at515, the user can perform a radiographical scan of the reaming to confirm the depth of the reaming that has been performed by visually sighting grooves (e.g.,116A and116B) on the cutting flutes of the reamer device100. According to some embodiments, fluoroscopy is performed to enable the visual inspection. According to some embodiments, Anterior-Posterior (AP) radiographs, lateral radiographs, and the like, can be performed during the visual check to determine the depth of grooves116(and correspondence of groove depth to the site of the fracture, for example).

At operation520, intramedullary nail120is inserted into the fibula.

According to some embodiments, the tissue protector and guide wire can be removed at520before or after insertion of intramedullary nail120. According to some embodiments, a visual check as described above (e.g., guided by fluoroscopy) can be performed while intramedullary nail120is inserted into the bone. According to some embodiments, intramedullary nail120can be rotated to allow for the anatomic placement of lateral screws, syndesmotic fixation, or other fixation into the tibia.

At operation525, after intramedullary nail120is inserted into the fibula, proximal/distal adjustments may be made to optimize alignment of the intramedullary device.

The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.

The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.