Patent Description:
In sternotomy surgeries, the patient's sternum is severed in half to create access to the inter-thoracic cavity to perform operative surgical procedures. Following such procedures, the two separated halves of the sternum must be repositioned adjacent to each other and affixed so that the two halves may be permitted to heal. Attempts have been made to constrain the separated halves together using wire threaded around the sternum and manually tensioned and twisted into place. However, wire can cause irritation to the sternum and other surrounding areas of the body, causing the patient additional pain and discomfort. Additionally, there are inherent inconsistencies from surgeon to surgeon as to the positioning of the wire, the tightness of the tensioning, the manner of twisting, etc..

Furthermore, after surgical procedures and/or a sternotomy, excess fluid (e.g. blood) may collect around a surgical site. If excess fluid is not removed, this excess fluid may become infectious, posing serious risk to the health of the patient and retarding or preventing recovery. Through ingenuity and effort, the inventors have developed various improvements to reclosure of the sternum following sternotomies and draining of related fluid. <CIT>describes a flexible fastening band connector which comprises a recess to receive a distal end portion of a flexible fastening band and lumen to receive the proximal end portion of the flexible fastening band.

The term "embodiment" used in the present specification does not necessarily indicate ways of carrying out the invention claimed but also examples which aid understanding the invention.

According to the present invention, a plate assembly for stabilizing a bone comprises a fixation plate having rails that form a window, wherein the window possesses an elongate shape; a band having a tail; and a head defining an internal cavity being configured to receive a portion of the tail, wherein the head includes a bottom portion, and wherein the bottom portion is configured to be passively received within the window of the fixation plate, wherein the fixation plate is configured to be positioned proximate to a bone, wherein the head is configured to be at least partially received at the fixation plate between the rails within the window, wherein the band is configured to be wrapped around the fixation plate and the bone, wherein the internal cavity of the head is configured to receive an end of the tail to form a loop, wherein the band is configured to receive a tension force to tighten the loop formed by the band, and wherein the elongate shape of the window is configured to permit the head to slide along the window. A plate assembly is contemplated having a fixation plate that may be positioned against a bone, such as the sternum, to assist in the stabilization of the bone. Bands are attached to the fixation plate and wrapped around the fixation plate and the bone so that the bands form a loop. The loops formed by the bands may be tensioned and eventually cut by a tensioning gun. The fixation plate has windows and other openings therein to generally create an open architecture within the fixation plate, and this open architecture may be beneficial to permit the free passage of blood and biological materials to effect healing at a bone site.

A surgical drain assembly (not claimed) may be provided in some embodiments as well. The surgical drain assembly may comprise a drain body that may be provided between the fixation plate and a bone (e.g. the sternum). The drain body may be snap fitted or otherwise attached to the fixation plate. Furthermore, the drain body may have extension tubes attached to the drain body, and the extension tubes may be wrapped behind the sternum or behind another bone to collect any excess fluid, such as blood, at that location. A drainage tube and/or an inlet tube may also be provided. The drainage tube may permit fluid collected from an internal cavity of the drain body to be removed from the patient's body, and the inlet tube may permit fluids (e.g. medicines, etc.) to be introduced to a surgical site via the surgical drain assembly. The drain body may be positioned above the sternum and the fixation plate to permit easy installation and removal of the drain body.

The tensioning gun (not claimed) may permit a user to set a tension limit, with this tension limit being the maximum tension that may be applied to a band using the tensioning gun. Once the tension limit has been reached, the tensioning gun may cease applying tension. In some embodiments, upon reaching the tension limit, a cutting blade may be activated to cut the band. Alternatively, the tensioning gun may continue to apply tension to the band at or around the tension limit, and the tensioning gun may cause a cutting blade to be actuated to cut the band. As another alternative, the tensioning gun may apply tension up to the tension limit, and the user may deploy another cutting tool to cut the band upon the tension limit being reached.

While bands may be manually installed, tensioned, and then cut, it may be disadvantageous to perform these tasks manually for several reasons. First, manual performance of these tasks can lead to human error. The bands may not be tightened to an appropriate tension and this may cause the patient to heal improperly and/or to experience pain (i.e. too loose may allow too much movement of the sternum; too tight may cause pain for the patient or too much tension on the sternum). Second, manual performance of the tasks will be less user-friendly. Where the fixation plate is being installed at a severed sternum, one or more installers would need to maintain the two severed sternum halves in an appropriate position, they would need to maintain the fixation plate at the appropriate position, and they would need to install bands to retain the fixation plate in the appropriate position. This may be difficult to do at the same time, increasing frustration for the installers and leading to an increased risk of error during installation. Third, manual performance of the tasks may very time consuming for installer(s).

Tensioning guns are contemplated that may be used to apply tension to bands until a desired tension level is reached. Once the desired tension level is reached, the tensioning gun may cut the band. The tensioning gun may reduce human error by maintaining a consistent amount of tension in each band. Manual tensioning places undue reliance on user judgment based on prior experience, visualization or tactile feel, and approximations or guesswork from the installer may lead to errors. The tensioning gun may be easier for installers to operate, thereby eliminating any approximations or guesswork from the installer as to whether the tension level is appropriate. By cutting the bands automatically after the desired tension is obtained, this may alleviate the need for the installer to perform this task separately. The tensioning gun may also tighten the bands more quickly than manual tightening of bands.

In an example embodiment, a plate assembly for stabilizing a bone is provided. The plate assembly includes a fixation plate having rails that form a window. The plate assembly also includes a band having a tail and a head defining an internal cavity being configured to receive a portion of the tail. The fixation plate is configured to be positioned proximate to a bone, and the head is configured to be at least partially received at the fixation plate between the rails within the window. The band is configured to be wrapped around the fixation plate and the bone. Furthermore, the internal cavity of the head is configured to receive an end of the tail to form a loop, and the band is configured to receive a tension force to tighten the loop formed by the band.

In some embodiments, the head may include a bottom portion, and this bottom portion may not include radially extending tabs. Additionally, in some embodiments, the bottom portion may be configured to be passively received within a window of the fixation plate.

In some embodiments, the head may be configured to be selectively removable from the window when no loop has been formed by the band, and the band may be configured to urge the head towards the fixation plate upon tightening of the loop formed by the band. Furthermore, the window may possess an elongate shape that is configured to permit the head to slide along the window in some embodiments. In some embodiments, translatory movement of the band may be at least partially restricted upon tightening of the loop formed by the band.

Additionally, in some embodiments, a shape of the bottom portion and a shape of the window may both configured to permit the band to rotate relative to the window when no tension is being applied to the band. Furthermore, in some embodiments, the bottom portion has a circular shape.

In some embodiments, a shape of the bottom portion and a shape of the window may both be configured to prevent the band from rotating relative to the window when no tension is being applied to the band. Furthermore, in some embodiments, the bottom portion may have a square shape, a triangular shape, a rectangular shape, a pentagonal shape, a hexagonal shape, an octagonal shape, or a star shape. In some embodiments, the bottom portion may simply have a square shape.

In some embodiments, a shape of the bottom portion may match the shape of the window. Further, receipt of the bottom portion in the window may be configured to prevent translatory movement of the bottom portion relative to the window. Additionally, in some embodiments, receipt of the bottom portion in the window may be configured to prevent rotational movement of the bottom portion relative to the window.

In some embodiments, the head may include a bottom lock having radially extending tabs. The rails may have protruding portions that extend into the window, and a portion of the head may be configured to be received within the window. The bottom lock may be configured to engage the protruding portions to restrict the head from being removed from the window.

In some embodiments, the bottom lock may possess a cam shape with reduced portions and enlarged portions. Edges of the enlarged portions may extend farther away from a center of the bottom lock than edges of the reduced portions. Additionally, in some embodiments, the band may be configured to rotate between an open position and a closed position, and the bottom lock may be oriented relative to the fixation plate such that the head may be removed from the fixation plate when the band is in an open position. The bottom lock may be oriented relative to the fixation plate such that the head may not be removed from the fixation plate when the band is in a closed position.

In some embodiments, the fixation plate may include one or more holes. The hole(s) may be configured to receive one or more additional fasteners. Further, in some embodiments, the additional fastener(s) may include at least one of a screw, a wire, and a suture.

In some embodiments, a tensioning tool may be used to apply a tension force to the band(s). The tensioning tool may have a tension limit that is the maximum tension that can be applied to a given band. The tensioning tool may be configured to apply tension to the band(s) until the tension limit has been reached.

Example embodiments of the present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. , Like reference numerals generally refer to like elements throughout. For example, reference numerals <NUM>, <NUM>, <NUM>, etc. may each refer to the head of a band. Additionally, any connections or attachments may be direct or indirect connections or attachments unless specifically noted otherwise.

Various bands may be provided that may be used to form loops that may be compressed around a sternum and tensioning plate. <FIG> illustrates a top view of a band according to the invention. The band <NUM> comprises an elongated strip including a tail <NUM> and a head <NUM>. The tail <NUM> may be wrapped around to engage with features on the head <NUM>, which may thereby form the band <NUM> into a loop. Furthermore, tension may be applied to the tail <NUM> to tighten the band <NUM>. The band <NUM> may be wrapped around one or more objects to constrain the movement of the objects. For example, the band <NUM> may be wrapped around a bone of a person. In some embodiments further described herein, the band <NUM> may be wrapped around a sternum of a person after surgery where the sternum has previously been cut.

Additional features of band <NUM> may be more readily understood in reference to <FIG>, which illustrate various enhanced views of a head <NUM> of the band <NUM>. The head <NUM> may define a top surface <NUM>, at least two sidewalls, a bottom surface, and an internal cavity where the end of the tail <NUM> may be received. The internal cavity may extend from the entrance <NUM> to the exit <NUM>. Looking at the cross-sectional view of <FIG>, the entrance <NUM> and exit <NUM> may be seen. In an embodiment, the entrance <NUM> may be located on the top surface <NUM> of the band <NUM>. In an embodiment, the exit <NUM> may be located on the top surface <NUM> of the band <NUM>. In an embodiment, the entrance <NUM> and the exit <NUM> are each located on the top surface <NUM> of the band <NUM> such that the tail <NUM> enters and exits the head <NUM> via the top surface <NUM>. A locking bar <NUM> which extends from one sidewall of the head <NUM> to the other sidewall of the head <NUM>, adjacent the top surface <NUM>, may separate the entrance <NUM> from the exit <NUM>.

The end of the tail <NUM> may be inserted through the entrance <NUM>, extended into the space between the pawl <NUM> and the locking bar <NUM>, and extended through the exit <NUM> (referred to herein as the insertion direction). As the end of the tail <NUM> extends toward the exit <NUM>, the pawl <NUM> may direct the tail <NUM> toward an exit ramp <NUM>. A portion of the tail <NUM> may contact the exit ramp <NUM>. The exit ramp <NUM> may be provided as a trough having a thirty degree angle in some embodiments, but other angles may be used for the exit ramp <NUM>. The exit ramp <NUM> may be linearly sloped in some embodiments, but the exit ramp may have a curved slope in other embodiments. In either case, the exit ramp <NUM> may be configured to urge the end of the tail <NUM> toward the top surface <NUM>, and thus the exit <NUM>, of the head <NUM>. After the end of the tail <NUM> has been inserted through the internal cavity and slides over the exit ramp <NUM> and out of the exit <NUM>, tension may be applied to the tail <NUM> to further tighten the tail <NUM>. Said alternatively, the end of the tail <NUM> may be pulled while maintaining the head <NUM> in a relatively stationary position to apply such tension.

Ridges 112A may be provided on the pawl <NUM>, and these ridges 112A of the pawl <NUM> may engage with ridges 202A (see <FIG>) on the top surface <NUM> of the tail <NUM> in some embodiments. The engagement of the ridges may generally prevent the band <NUM> from being untightened or from moving in the direction opposite the insertion direction. To disengage the band <NUM>, an operator may simply cut the band <NUM>, making the band <NUM> easily removable if necessary.

The head <NUM> of the band <NUM> may include a top portion <NUM> and a bottom lock <NUM>. A gap <NUM> may be defined between the top portion <NUM> and the bottom lock <NUM>. As described further herein, the gap <NUM> between the top portion <NUM> and the bottom lock <NUM> may be used to receive a portion of a fixation plate <NUM> to restrain the movement of the band <NUM> relative to the fixation plate <NUM> (see <FIG>).

Furthermore, in some embodiments, the head <NUM> may include pockets <NUM>. The illustrated embodiment includes two pockets <NUM>, but any number of pockets may be used. The pockets <NUM> may be configured to assist in generating tension between the tail <NUM> and the head <NUM> of the band <NUM>, as will be more fully explained herein.

In some embodiments, the bands <NUM> may be pre-bent or curved at a pre-determined radius. This may help facilitate maneuverability of the bands <NUM> through and under the intercostal spaces and under the posterior surface of the sternum.

<FIG> illustrate various enhanced views of a head of another band. Looking at <FIG>, a tail <NUM> having ridges 202A is illustrated on the left, and the head <NUM> of the band is illustrated on the right. As noted above, the end of the tail <NUM> may be wrapped around and inserted into an internal cavity extending from the entrance <NUM> to the exit <NUM> within the head <NUM>. Looking at <FIG>, the end of the tail <NUM> may be inserted through the entrance <NUM>, extend underneath the locking bar <NUM>, and extend out through the exit <NUM>. The locking bar may include ridges similar to the ridges 112A illustrated on the pawl <NUM> of <FIG>. As illustrated in <FIG>, as the end of the tail <NUM> extends out through the exit <NUM>, the tail <NUM> may rest on the exit ramp <NUM>.

Additionally, the head <NUM> of the band may include a top portion <NUM> and a bottom lock <NUM>. A gap may be defined between the top portion <NUM> and the bottom lock <NUM>. As described further herein, the gap between the top portion <NUM> and the bottom lock <NUM> may be used to restrain the movement of the head <NUM> of the band relative to a fixation plate <NUM> (see <FIG>). The head <NUM> may be different from the head <NUM> of <FIG> in that only a single locking bar <NUM> is provided without a separate pawl. Furthermore, the overall shape of the head <NUM> may be more rounded than the head <NUM>. Additionally, the head <NUM> is provided without any pockets <NUM> (see <FIG>). Additionally, the bottom lock <NUM> may be tapered to increase the ease of installing the head <NUM> in a window of a fixation plate <NUM> (see <FIG>).

<FIG> illustrates an enhanced cross-sectional view of the head <NUM> of another example band. <FIG> also permits the tail <NUM> of the band to be seen. The end of the tail <NUM> may be wrapped around and inserted into an internal cavity extending from the entrance <NUM> to the exit <NUM> within the head <NUM>. Looking at <FIG>, the end of the tail <NUM> may be inserted through the entrance <NUM>, extend underneath the locking bar <NUM> but above the pawl <NUM>, and extend out through the exit <NUM>. The pawl <NUM> may include ridges 312A similar to the ridges 112A illustrated on the pawl <NUM> of <FIG>. Where this is the case, ridges may be provided on the bottom surface of the tail <NUM> so that the ridges of the tail <NUM> may engage with the ridges 312A of the pawl <NUM>.

Additionally, the head <NUM> of the band may include a top portion <NUM> and a bottom lock <NUM>. A gap may be defined between the top portion <NUM> and the bottom lock <NUM>. As described further herein, the gap between the top portion <NUM> and the bottom lock <NUM> may be used to restrain the movement of the head <NUM> of the band relative to a fixation plate <NUM> (see <FIG>). In the head <NUM> of <FIG>, the top portion <NUM> may be enlarged on both the entry side (on the right) and on the exit side (on the left) relative to the head <NUM> of <FIG> so that the top portion may have a larger interface surface with a fixation plate <NUM> (see <FIG>).

<FIG> illustrate various enhanced views of a head <NUM> of another band. <FIG> also permits the tail <NUM> of the band and ridges 402A on the tail <NUM> to be seen. The end of the tail <NUM> may be wrapped around and inserted into an internal cavity extending from the entrance <NUM> to the exit <NUM> within the head <NUM>. Looking at <FIG>, the end of the tail <NUM> may be inserted through the entrance <NUM>, extend underneath the pawl <NUM>, and extend out through the exit <NUM>. The pawl <NUM> may include ridges 412A similar to the ridges 112A illustrated on the pawl <NUM> of <FIG>. Similar to other embodiments, the head <NUM> may include a top portion <NUM> and a bottom lock <NUM> that may create a gap configured to restrain the movement of the head <NUM> of the band relative to a fixation plate <NUM> (see <FIG>). The exit ramp <NUM> (see <FIG>) for the head <NUM> is also curved, unlike the exit ramp <NUM> of <FIG>.

<FIG> illustrate various enhanced views of another example band. The end of the tail <NUM> may be wrapped around and inserted into an internal cavity extending from the entrance <NUM> to the exit <NUM> within the head <NUM>. Looking at <FIG>, the end of the tail <NUM> may be inserted through the entrance <NUM>, extend under the locking bar and above a pawl, and extend out through the exit <NUM>. The pawl may include ridges similar to the ridges 112A illustrated on the pawl <NUM> of <FIG>. Similar to other embodiments, the head <NUM> may include a top portion <NUM> and a bottom lock <NUM> that may create a gap configured to restrain the movement of the head <NUM> of the band relative to a fixation plate <NUM> (see <FIG>).

The head <NUM> may also include one or more pockets <NUM>. In the illustrated embodiment, two pockets <NUM> are illustrated. The pockets <NUM> may provide a location where alignment features <NUM> (see <FIG>) of a tensioning gun <NUM> (see <FIG>) may be received. The pockets <NUM> may provide leverage for the tensioning gun <NUM> as the tensioning gun <NUM> applies tension to a head <NUM>.

Various fixation plates are also contemplated that may be used to assist in securing two severed halves of a severed sternum together. Fixation plates may comprise materials and possess features that permit the fixation plates to conform to the shape of the underlying bone. Furthermore, the fixation plates may disperse any stress generated by bands across a greater surface area on the underlying bone to prevent stress concentrations at specific locations where the bands are provided. <FIG> illustrate various views of an example fixation plate <NUM>. The fixation plate <NUM> may generally comprise an elongated body, similar in length and width to a portion of the human sternum. The fixation plate <NUM> may include at least two rails <NUM> that extend lengthwise. In an embodiment, the rails <NUM> may be connected to one another via crossbars <NUM>. In another embodiment, the fixation plate <NUM> may comprise two rails <NUM> and two crossbars <NUM> (one at each end - see <FIG>). In an embodiment, the fixation plate <NUM> may comprise two rails <NUM> and three crossbars <NUM>. In another embodiment, the fixation plate <NUM> may comprise two rails <NUM> and five crossbars <NUM>. Any number of rails <NUM> and crossbars <NUM> are contemplated herein. The rails <NUM> and crossbars <NUM> may form one or more windows <NUM> (i.e. open cavities). The windows <NUM> may be configured to receive the head <NUM> of a band <NUM> (see <FIG>). Three windows <NUM> are illustrated in <FIG>, but any number of windows <NUM> may be included. In one embodiment, the fixation plate <NUM> might resemble a ladder, consisting of parallel longitudinal rails <NUM> joined by multiple crossbars <NUM> occurring at various points along the long axis of the fixation plate <NUM>, creating windows <NUM> within the central region of the fixation plate <NUM>. In an embodiment, the fixation plate <NUM> may extend the entire length of the forward-facing aspect of the sternal anatomy from the manubrium to the xiphoid process, but the fixation plate <NUM> may be configured to extend only a portion of this length in other embodiments.

In some embodiments, the windows <NUM> are ovular or elliptical in shape. In other embodiments, the windows <NUM> are square or rectangular in shape. Any shape known in the art may be utilized herein. In some embodiments, the windows <NUM> may be positioned and sized differently from one another. That is, in the lengthwise direction, the fixation plate <NUM> may not be symmetrical. The fixation plate <NUM> may comprise two longer windows <NUM> on one lengthwise side of the contoured section <NUM> (explained below), one window <NUM> of moderate length on the other lengthwise side of the contoured section <NUM>, and one shorter window <NUM> within the contoured section <NUM>, in an embodiment. Likewise, the widths of the various windows <NUM> may vary. One or more windows <NUM> may have a first width while one or more other windows <NUM> may have a second width.

As can be seen in <FIG>, the rails <NUM> may include a protruding portion 626A that extends partially into a window <NUM>. This protruding portion 626A may extend into the gap <NUM> (see <FIG>) formed between the top portion <NUM> and the bottom lock <NUM> of the head <NUM> of a band <NUM> (see <FIG>). When the protruding portion 626A extends into this gap <NUM> (see <FIG>), the engagement between the protruding portion 626A and the head <NUM> of the band <NUM> (see <FIG>) may restrict the movement of the head <NUM>-the head <NUM> may be permitted to slide along the length of the window (i.e. along the rails, left and right in <FIG>), but the engagement may prevent the head <NUM> from moving perpendicular to the window (i.e. toward the rails, up and down in <FIG>). The engagement between the protruding portion 626A and the head <NUM> may keep the head <NUM> retained in the window <NUM>, but, upon the application of sufficient force, one may remove the head <NUM> from the window <NUM> if desired. Alternatively, the bottom lock <NUM> of the head <NUM> of the band <NUM> may be keyed to passively insert through the window <NUM> when the head <NUM> is partially rotated (e.g. by rotating the bottom lock <NUM> by <NUM> degrees), and the bottom lock <NUM> may then become locked underneath the rails <NUM> by partially rotating the bottom lock <NUM> (e.g. by rotating the bottom lock <NUM> in a reverse direction by <NUM> degrees). The bottom lock <NUM> may be a twist lock in some embodiments. Where the fixation plate <NUM> is used with a sternum, the rails <NUM> of the fixation plate <NUM> may have a height (H) that is less than <NUM> in some embodiments. This reduced height (H) may make the fixation plate <NUM> have a lower profile, with the bands wrapped closer to the bone. This may reduce the amount that the band needs to change in direction, and this may increase the amount of surface area on the bone that the band comes into contact with. However, other larger or smaller sized fixation plates <NUM> may be used at the sternum. Furthermore, where the fixation plate <NUM> is used with a larger bone such as femur, the fixation plate <NUM> may have height that is <NUM> millimeters or greater.

The fixation plate <NUM> may also include one or more reinforced areas. In the illustrated embodiment, three reinforced areas are provided, with each of these reinforced areas being at the crossbars <NUM>. As illustrated in the side view of <FIG>, the reinforced areas may have increased thickness and/or strength compared to other portions of the fixation plate <NUM>. In some cases, the reinforced areas may also assist in providing an end point to the windows <NUM> to restrict the movement of a head <NUM> of a band <NUM>. The reinforced areas that may provide strength and reinforcement and may disperse the structural load acting on the fixation plate <NUM> across the fixation plate <NUM> to minimize stress points.

In some embodiments, the reinforced areas may be provided at the crossbars <NUM> to provide rigidity against bending in the horizontal direction (up and down from the perspective in <FIG>) while permitting bending of the fixation plate <NUM> in the vertical direction (lengthwise, left and right from the perspective in <FIG>). By doing so, the fixation plate <NUM> may be free to bend in the vertical direction to conform to the shape of a sternum and may allow the patient to retail natural movement of the sternum. However, the reinforced areas may have limited rigidity against bending in the horizontal direction in other embodiments so that the fixation plate <NUM> may also be free to easily bend in the horizontal direction to conform to the shape of a sternum.

As illustrated in <FIG>, <FIG>, and <FIG>, the fixation plate <NUM> may include a contoured section <NUM>. The contoured section <NUM> may be provided so that the fixation plate <NUM> may more easily conform to the shape of the underlying sternum. In an embodiment, the bottom surface <NUM> of the fixation plate <NUM> may generally be linear, but the contoured section <NUM> may bow inwardly, in a curved or angular manner, toward a top surface <NUM> of the fixation plate <NUM>. For example, the contoured section <NUM> may be configured to be placed over the sternal manubrial junction or the angle of Louis on the sternum in some embodiments. Additionally, a contoured section <NUM> may be placed over the sternal body xiphoid junction. In some embodiments, the fixation plate <NUM> may have areas of increased flexibility to allow it to better conform to the specific anatomy of a given patient at certain areas (e.g. the sternal manubrial junction, the sternal body xiphoid junction, etc.).

The bottom surface <NUM> of the fixation plate <NUM> may also include one or more spikes 732A (see <FIG>) to assist in gaining traction between the fixation plate <NUM> and the severed sternum (see <FIG>). However, the bottom surface <NUM> may be free from any spikes in some embodiments. One or more cavities <NUM> may be provided in some embodiments at the bottom surface <NUM> of the fixation plate <NUM>. The windows <NUM> and the cavities <NUM> may provide an open architecture to allow for bodily fluids to flow through to permit proper healing at a cut <NUM> in the severed sternum <NUM> (see <FIG>). The radius R at the end of the windows <NUM> may have a large size to ensure that the head <NUM> of a band <NUM> may slide the maximum distance of the window <NUM>. The fixation plate <NUM> may provide sufficient stiffness and rigidity to buttress an injured bone (e.g. the sternum) while providing sufficient ductility to conform to the shape and contours of the underlying bone.

Another alternative fixation plate <NUM> is also illustrated in <FIG>. Similar to the fixation plate <NUM> of <FIG>, the fixation plate <NUM> may include a window <NUM>. The fixation plate <NUM> may include rails <NUM> that assist in forming the window <NUM>. The window <NUM> may be configured to receive the head <NUM> of a band <NUM> (see <FIG>). As can be seen in <FIG>, the rails <NUM> may include a protruding portion 726A that extends into the window <NUM>. This protruding portion 726A may extend into the gap <NUM> (see <FIG>) formed between the top portion <NUM> and the bottom lock <NUM> of the head <NUM> of a band <NUM> (see <FIG>) to restrict the movement of the head <NUM>. The protruding portion 726A may operate similar to the protruding portion 626A of <FIG>.

As illustrated in <FIG>, the fixation plate <NUM> has a bottom surface <NUM>, and this bottom surface <NUM> is flat in the fixation plate <NUM> of <FIG>. However, in other embodiments, the bottom surface <NUM> may have a concave shape, a convex shape, or some other non-flat shape. For example, the bottom surface <NUM> may be slightly concave so that the fixation plate <NUM> may follow the natural anatomic radius of the sternum. Furthermore, as illustrated in <FIG>, the fixation plate <NUM> may have spikes 732A on the bottom surface <NUM> in some embodiments. The spikes 732A may have sharp tips or dull tips in some embodiments, and the spikes 732A may be configured to engage bone at the sternum to minimize any noticeable pain for the patient. A single spike may be provided in some embodiments, or a plurality of smaller spikes may be used. Furthermore, the spikes 732A may possess a wide variety of shapes. In the illustrated embodiment, the spikes 732A have a rectangular pyramid shape. However, the spikes may be cone shaped, in another pyramid shape, in the shape of a triangular prism, asymmetrically shaped, etc. Likewise, in place of spikes 732A, the plate may be textured with bunt pegs or some other feature to permit improved traction on the bottom surface <NUM>.

<FIG> illustrate various views of another example fixation plate <NUM>. The fixation plate <NUM> may include rails <NUM> that assist in forming windows <NUM>. This fixation plate <NUM> may also have protruding portions 826A, crossbars <NUM> having reinforced areas, and a bottom surface <NUM> that may operate in generally the same manner as similar features described above. The fixation plate <NUM> may have a flatter shape than the fixation plate <NUM> of <FIG> as the fixation plate <NUM> may be provided without any contoured section <NUM>.

<FIG> illustrate various views of another example fixation plate <NUM>. The fixation plate <NUM> may include rails <NUM> that assist in forming windows <NUM>. This fixation plate <NUM> may also have protruding portions 926A, crossbars <NUM> having reinforced areas, and a bottom surface <NUM> that may operate in generally the same manner as similar features described above. Like the fixation plate <NUM> of <FIG>, the fixation plate <NUM> may include a contoured section <NUM> to permit the fixation plate <NUM> to accommodate the shape of certain features on the sternum. However, certain features on the fixation plate <NUM> may have a different shape and/or size than the fixation plate <NUM>. For example, the contoured section <NUM> possesses a different shape than the contoured section <NUM> of the fixation plate <NUM>. Additionally, the reinforced areas may have narrower width than the reinforced areas of the fixation plate <NUM> of <FIG>. Furthermore, the fixation plate <NUM> may have a low profile with the height of the rails <NUM> (see <FIG>) being smaller than rails of most other embodiments, and this smaller height may allow a band installed in the fixation plate <NUM> to be provided closer to the bone and reduce any change in direction for an installed band. The height of the rails <NUM> may be the same as the height (H) of the rails <NUM> in <FIG>.

The fixation plate <NUM> may contain nodes in some embodiments. These nodes may be large enough to span the sternum of the patient, and the nodes may contain a feature that may accept the head or tail of an independent fasteners such as but not limited to bands, screws, or cable ties. Furthermore, in some alternative embodiments, the fixation plate may have bands integrated into the fixation plate itself so that the installer will not be required to attach the bands to the fixation plate.

A fixation plate may be selected that may best conform to the size and shape of the sternum of a given patient, and the provision of fixation plates having different sizes and shapes may be beneficial to accommodate this. After a fixation plate has been selected, the head of a band may be removably attached to the fixation plate within a window in the fixation plate. <FIG> illustrates a top view of an example fixation plate <NUM> with an example band <NUM> assembled to the fixation plate <NUM>. As can be appreciated, the bottom lock <NUM> of the head <NUM> may be inserted into the window <NUM>. Due to the engagement between the head <NUM> and the window <NUM>, the head <NUM> may be permitted to shift along the track formed by the window <NUM>. For example, in the embodiment illustrated in 10A, the head <NUM> may move up and down along the track formed by the window <NUM>. Furthermore, in the embodiment illustrated in 10A, the engagement of the head <NUM> may prevent the head <NUM> (<NUM>) from moving to the left or the right; (<NUM>) from moving into or out of the page (unless sufficient force is provided to remove the head <NUM> from the window <NUM>). The head <NUM> may be shaped in a manner that permits the head <NUM> to rotate as it is retained in the window <NUM>. For example, in the illustrated embodiment of <FIG>, the head <NUM> is rotated at an angle, and this may be beneficial to form an X-pattern, to fit to the anatomy of the patient, to apply forces to the sternum in other directions, etc. Where multiple bands <NUM> are installed in the window <NUM>, the bands <NUM> may be permitted to slide and pivot independently of each other in some embodiments. Furthermore, <FIG> illustrate a cross-sectional view of the fixation plate <NUM> and band <NUM> of <FIG> about the line H'-H'.

Looking at <FIG>, various features of the fixation plate <NUM> and the band <NUM> may be seen. The band <NUM> may include a head <NUM> and a tail <NUM>. Similar to the embodiments of fixation plates discussed above, the fixation plate <NUM> may include rails <NUM> that assist in forming windows <NUM>. The fixation plate <NUM> may also include a protruding portion 1026A that extends into a window <NUM>.

This protruding portion 1026A may extend into a gap formed between the top portion <NUM> and the bottom lock <NUM> of the head <NUM> of a band. When the protruding portion 1026A extends into this gap, the engagement between the protruding portion 1026A and the head <NUM> of the band <NUM> may have restrict the movement of the head <NUM>-the head <NUM> may be permitted to slide along the window <NUM> (left and right in <FIG>), but the engagement may prevent the head <NUM> from moving perpendicular to the window <NUM> (up and down in <FIG>). The engagement between the protruding portion 1026A and the head <NUM> may keep the head <NUM> retained in the window <NUM>, but, upon the application of sufficient force, one may remove the head <NUM> from the window <NUM> if desired. The head <NUM> may be snapped in with or without aid on an external tool with forced pressure in some embodiments. The bottom lock <NUM> of the head <NUM> may be made of elastic material in some embodiments to permit the bottom lock <NUM> to deform a sufficient amount so that the bottom lock <NUM> may extend under the windows <NUM>. The head <NUM> may be attached to the fixation plate <NUM> within the window <NUM> at a location proximate to an intercostal space <NUM> (see <FIG>) or the head <NUM> may be attached and then slid to an appropriate location.

In some embodiments, the bottom lock of the head may have a circular shape, and the width of the bottom lock may be a diameter of the bottom lock in that case. Examples of such a circularly shaped bottom lock are illustrated in <FIG>, <FIG>, and <FIG>. However, in other embodiments, the bottom lock may possess other shapes. Where a circularly shaped bottom lock is utilized, the width of the bottom lock may be greater than the width of the window <NUM> (e.g. the width runs left and right in <FIG>). Where this is the case, the head <NUM> may be attached to the fixation plate <NUM> between the rails <NUM> within a window <NUM> by applying a force on the head <NUM> to urge the bottom lock towards the rails <NUM>, and the bottom lock may be configured to bend elastically upon application of the force to permit the bottom lock to extend through the window <NUM>.

In other embodiments, the bottom lock may have a non-circular shape (e.g. oval shaped, rectangularly shaped, etc.), and the bottom lock may define a minimum width and a maximum width. An example of this is illustrated in the bottom lock <NUM> of <FIG>. The bottom lock <NUM> may have a maximum width (W1) as illustrated in <FIG>, and the bottom lock <NUM> may have a minimum width (W2) as illustrated in <FIG>. The minimum width (W2) of the bottom lock <NUM> may be less than the width of the window <NUM>, and the maximum width (W2) of the bottom lock <NUM> may be greater than the width of the window <NUM>. Where this is the case, the head <NUM> may be attached to the fixation plate <NUM> by rotating the head <NUM> so that the bottom lock <NUM> may fit through the window <NUM> (i.e. so that the width of the bottom lock <NUM> becomes less than the width of the window <NUM>). Once the bottom lock <NUM> has been received in the window <NUM>, the head <NUM> may be rotated again so that the bottom lock <NUM> may be retained within the window <NUM>. Once rotated, the width of the bottom lock <NUM> may be greater than the width of the window <NUM>. Other bottom locks <NUM> are also contemplated. For example, the bottom lock <NUM> may have a portion that is expandable and retractable, allowing the bottom lock <NUM> to be retracted so that it may be inserted into a window <NUM> and allowing the bottom lock <NUM> to be expanded so that it may be retained in the window <NUM>.

Looking now at <FIG>, the tail <NUM> may be looped around into the internal cavity extending from the entrance <NUM> to the exit <NUM>, extending along the path of the arrows illustrated in <FIG> (the insertion direction). The end of the tail <NUM> may be inserted through the entrance <NUM>, above the pawl <NUM> and below the locking bar <NUM>, through a binding area <NUM>, and out of the exit <NUM>. The tail <NUM> may be retained at the binding area <NUM> as the pawl <NUM> and the locking bar <NUM> may be urged against the tail <NUM>. A buckling action may be created at the binding area <NUM>, and this may permit further portions of the tail <NUM> to be inserted through the internal cavity (e.g. along the path of the arrows) without permitting reverse movement of the tail <NUM> in the opposite direction.

While the fixation plate <NUM> is effectively affixed to bone using bands <NUM> in the illustrated embodiment, the fixation plate <NUM> may also be affixed to bone with cerclage wire or other cabling techniques whereby cerclage wire or cable passes over and around the fixation plate <NUM> as the fixation plate <NUM> rests on the bone. Where this is done, the fixation plates may include slots that may be configured to receive wire or other cables. The fixation plate <NUM> and one or more bands <NUM> may be attached together before being inserted into the body of the patient in some embodiments, but the bands <NUM> may simply be attached to the fixation plate <NUM> once the fixation plate <NUM> has been inserted into the body of the patient in other embodiments.

While the bands may be manually installed, tensioned, and then cut, it may be detrimental to perform these tasks manually for several reasons. First, manual performance of these tasks can lead to human error. The fixation plate may not be installed properly or the bands may not be tightened to an appropriate tension, and this may cause the patient to heal improperly. Second, manual performance of the tasks will be less user-friendly. Where the fixation plate is being installed at a severed sternum, one or more installers would need to maintain the two severed sternum halves in an appropriate position, they would need to maintain the fixation plate at the appropriate position, and they would need to install bands to retain the fixation plate in the appropriate position. This may be difficult to do at the same time, increasing frustration for the installers and leading to an increased risk of error during installation. Third, manual performance of the tasks may very time consuming for installer(s).

Tensioning guns are contemplated that may be used to apply tension to bands until a desired tension level is reached. Once the desired tension level is reached, the tensioning gun may cut the band. The tensioning gun may reduce human error by maintaining a consistent amount of tension in each band. Manual tensioning places undue reliance on user judgment based on prior experience, visualization or tactile feel, and approximations or guesswork from the installer may lead to errors. The tensioning gun may be easier for installers to operate eliminating any approximations or guesswork from the installer as to whether the tension level is appropriate. By cutting the bands automatically after the desired tension is obtained, this alleviates the need for the installer to perform this task separately. The tensioning gun may also tighten the bands up more quickly than manual tightening of bands.

<FIG> illustrates a perspective view of an example tensioning gun <NUM> being used to generate tension on an example band <NUM>, and <FIG> illustrates an enhanced view of the tensioning gun <NUM> and band <NUM> of <FIG>.

Looking first at <FIG>, various features of the tensioning gun <NUM> may be seen. The tensioning gun <NUM> may tension the bands <NUM> to precise levels. The tensioning gun <NUM> may include a handle <NUM> and a actuator lever <NUM>. One may hold the handle <NUM> as he or she is using the tensioning gun <NUM>. Further, the actuator lever <NUM> may be compressed when the user desires to provide tension to the band <NUM>. In some embodiments, upon the desired tension being reached, the tensioning gun <NUM> may cease providing further tension, and the properties of the band may maintain this tension. For example, the band, the pawl, and the locking bar and any ridges thereon may generally maintain the tension at this level, but other locking mechanisms may be used to prevent the tension on the band <NUM> from being released. The trim system <NUM> may automatically be actuated so that the band <NUM> may be cut. However, in other embodiments, a separate button may be provided that may be pressed when the user desires to actuate the trim system <NUM>, and the user may press this separate button once the desired tension is obtained. The actuator lever <NUM> may be provided with a high mechanical advantage ratio so that it may be used more easily.

Additionally, the tensioning gun <NUM> may include a barrel <NUM> with one or more features provided therein. The barrel <NUM> may contain an internal chamber that generally runs along the length of the barrel <NUM>. The barrel <NUM> may include a trim system <NUM> disposed proximate to the end of the barrel <NUM>. Furthermore, a safety lock <NUM> is provided on the barrel <NUM>. The safety lock <NUM> may be provided in the form of a switch, a lever, etc., and the safety lock <NUM> may prevent premature or unintended cutting of bands <NUM>. The safety lock <NUM> may be in a locked state to prohibit tension from being applied via the tensioning gun <NUM> and/or to prevent the trim system <NUM> from cutting the bands <NUM>. Furthermore, the safety lock <NUM> may be in an unlocked state to permit tension to be applied via the tensioning gun <NUM> and/or to permit the trim system <NUM> to cut the bands. While the safety lock <NUM> is provided on the barrel <NUM> in <FIG>, the safety lock <NUM> may be provided at another location in other embodiments. The safety lock <NUM> may be provided on the left side, the right side, on both sides, on the rear, etc. of the tensioning gun <NUM>. In other embodiments, a secondary switch, lever, etc. may be added to the tensioning gun <NUM> to actuate cutting.

Furthermore, a tension limit system <NUM> (see <FIG>) may be provided. This tension limit system <NUM> may be provided in the barrel <NUM> in some embodiments, but the tension limit system <NUM> may be provided at other locations. A knob <NUM> may be provided to permit the desired tension level to be adjusted by a user. A top view showing a similar knob <NUM> is also provided in <FIG>. Adjustment of the knob <NUM> or the knob <NUM> may cause a corresponding adjustment to be made at the tension limit system <NUM>, preventing tension from being applied past a maximum level. While a knob <NUM> may be used as illustrated, other clutch mechanisms may be used in other embodiments to limit the amount of tension that may be applied to the bands.

In some embodiments, the tension limit system <NUM> may include a spring-loaded probe. The spring-loaded probe may extend proximate to the end of the barrel <NUM>, and the spring-loaded probe may extend proximate to the trim system <NUM> (see <FIG>). The spring-loaded probe may require depression of the probe into a corresponding barrel cavity before the trim system <NUM> may cut any band. This tension limit system <NUM> may prevent premature or unintentional band cutting. The tension limit system <NUM> may also allow cutting only when the tip of the barrel <NUM> and the cutting blade <NUM> (see <FIG>) are seated at the lowest and most optimal position to ensure a flush cut of the band.

Looking now at <FIG>, the engagement between the tensioning gun <NUM> and the head <NUM> of a band <NUM> may be seen. The tensioning gun <NUM> may include two alignment features <NUM> extending from the barrel <NUM>, but any number of alignment features <NUM> may be used. A channel <NUM> may be provided between the two alignment features <NUM> where the tail of the band <NUM> may be received and positioned within the barrel <NUM> of the tensioning gun <NUM>. The channel <NUM> may correspond to the cross-sectional shape of the band <NUM> so that the free end of the tail for the band <NUM> may be precisely fed into the channel <NUM> in a controlled manner. The tensioning gun <NUM> may receive the excess portion of the band <NUM> without unduly altering the angle of the band <NUM> - by doing this, the amount of stress and strain acting on the band <NUM> and tensioning gun <NUM> may be reduced, and the amount of tension that must be applied by the tensioning gun <NUM> may be reduced.

The head <NUM> may have pockets <NUM> (see <FIG>) that are configured to receive the alignment features <NUM>. As the tensioning gun <NUM> is applying tension, the alignment features <NUM> may be urged against a wall in a pocket <NUM> to provide leverage. The alignment features <NUM> may ensure that the tensioning gun <NUM> is appropriately positioned relative to the bands <NUM>. This positioning may help ensure that that the head <NUM> of the band <NUM> is maintained in a stationary position as tension is applied. By ensuring this proper positioning, the tension level in installed bands <NUM> may be consistent, and errors may be avoided. By applying tension to the bands <NUM> (e.g., by pulling the tail of the band <NUM> into the tensioning gun <NUM> via actuation of the actuator lever <NUM> while maintaining the head <NUM> of the band <NUM> in a stationary position), the bands <NUM> may tighten around the fixation plate <NUM> (see <FIG>) and bone and cause the fixation plate <NUM> to conform to the shape of the underlying sternum.

Upon continuous actuation of the actuator lever <NUM>, the band <NUM> may advance through the channel <NUM>. As more portions of the band <NUM> have advanced into the channel <NUM>, more tension may be applied to the bands <NUM> to oppose further advancement of the bands <NUM> in the insertion direction. This increased tension may occur due to the engagement between the notches 112A in the head <NUM> and notches 102A of the tail <NUM> (see, e.g., <FIG>). This increased tension may also occur based on other forces acting on other portions of the loop formed by the tail <NUM> as the loop extends around the bone and the fixation plate.

The tensioning gun <NUM> may be removed quickly and easily, and the tensioning gun <NUM> may only grip a band <NUM> when the actuator lever <NUM> is being actuated. To the extent an installer wishes to apply further tensioning after using the tensioning gun <NUM> once, the tensioning gun <NUM> may be subsequently reintroduced over the exposed free tail end of a band <NUM>.

In some embodiments, the tensioning gun <NUM> may contain other features such as a battery operated light source such as LED or a fiber optic light source. Additionally, the tensioning gun <NUM> might contain suctioning and/or irrigating capability or have a mount or fitting where such capabilities may be attached to the device. Where this is the case, batteries may be provided in the tensioning gun <NUM>, or some other power source may be included in the tensioning gun <NUM>. While various features of the tensioning gun <NUM> are mechanically actuated in the illustrated embodiment of <FIG> and <FIG>, the tensioning gun <NUM> may include electronic circuitry in some embodiments to set the tension limit, to determine the applied tension, to actuate the trim system, etc. In some embodiments, the tensioning gun <NUM> may include a memory to store computer readable instructions, and the tensioning gun <NUM> may also include a user interface to permit user inputs.

Other view of an example tensioning gun are also provided in <FIG>. <FIG> illustrates a top view of an example tensioning gun <NUM>, and <FIG> illustrates a side view of the tensioning gun <NUM> of <FIG>. Similar to the tensioning gun <NUM>, the tensioning gun <NUM> may have a handle <NUM>, a actuator lever <NUM>, a safety lock <NUM>, alignment features <NUM>, a channel <NUM>, and a tension limit system <NUM>. <FIG> illustrates a top view of the tensioning gun <NUM>, permitting the tension limit system <NUM> to be seen. In some embodiments, no top surface is provided for the tensioning gun <NUM>. This may be beneficial to permit cut portions of a band to be easily removed from the tensioning gun <NUM>. Cut portions of a band may be easily removed from the tensioning gun <NUM> upon deactivation or release of the actuator lever <NUM>. However, a top surface may be provided in other embodiments to contain the features of the tensioning gun <NUM> (e.g. the tension limit system <NUM>).

Further features of an example tensioning gun are provided in <FIG>. <FIG> illustrates a perspective view of an example tensioning gun <NUM> being used to generate tension on an example band <NUM> where a sidewall of the tensioning gun <NUM> is made transparent, and <FIG> illustrates an enhanced view of the tensioning gun <NUM> of <FIG>. Looking at <FIG>, the tail of the band <NUM> may be looped around and then the free end of the tail may be inserted through the channel <NUM> (see <FIG>) formed in the tensioning gun <NUM> between the alignment features <NUM> (see <FIG>). Excess portions of the tail may extend through the channel <NUM>. Once cut, one may remove the excess portions of the tail through an open top surface.

<FIG> permits portions of a trim system <NUM> provided in the tensioning gun <NUM> to be seen. The trim system <NUM> may be provided with a cutting blade <NUM>, and the trim system <NUM> may be configured to receive an indication of whether or not the tension limit has been reached at the tension limit system <NUM> (see <FIG>). Upon the tension limit being reached, the trim system <NUM> may be activated automatically so that the cutting blade <NUM> may cut the excess portions of a tail. The cutting blade <NUM> may cut the tail so that no jagged edges remain. The trim system <NUM> may be located proximate to the end of the barrel <NUM>. Placement of the trim system <NUM> at this location may assist in ensuring a flush cut of the band so no portion of the remaining band may irritate overlying tissues and/or be palpated by the patient and potentially cause discomfort.

The tensioning gun <NUM> may apply tension to a band <NUM> prior to and at the time of cutting using a cam mechanism <NUM> housed within the tensioning gun <NUM>. This cam mechanism <NUM> may be part of the tension limit system <NUM> (see <FIG>) in some embodiments. The cutting blade <NUM> may be activated while the band <NUM> is under tension, and this may permit the cut to be performed with less force than if the band <NUM> in not tensioned. Another consequence of a band <NUM> being cut while under tension is that the band <NUM> recoils slightly after cutting. This may cause retraction of the tail <NUM> (see <FIG>) of the band <NUM> protruding though the internal cavity of the head <NUM> (see <FIG>). This retraction may keep the cut end of the band <NUM> flush to or beneath the top surface of a head <NUM> (see <FIG>).

The tensioning gun may apply tension to a band to tighten loops formed by the band. <FIG> illustrates an enhanced, cross sectional view of an example tensioning gun being used to generate tension on a band <NUM>. As illustrated, the tail <NUM> of the band <NUM> may proceed in a manner similar to that shown in <FIG>. The tail <NUM> may be inserted through the entrance <NUM> (see <FIG>), through a binding area <NUM> (see <FIG>) where the tail <NUM> may be constrained between a pawl <NUM> (see <FIG>) and a locking bar <NUM> (see <FIG>), and out of the exit <NUM> (see <FIG>). Once the end of the tail <NUM> has been inserted in this manner, the tail <NUM> may be provisionally tensioned further and/or the end of the tail <NUM> may be inserted into the tensioning gun for further tensioning. The alignment features <NUM> operate similarly to other alignment features discussed herein to assist in engaging the head of the band <NUM>.

<FIG> illustrates a schematic view of an example cutting blade <NUM> of a trim system for a tensioning gun being used to cut an excess portion of a tail <NUM> for a band. The trim system may be provided with a cutting blade <NUM>, and the trim system may be configured to receive an indication of whether or not the tension limit has been reached at the tension limit system <NUM> (see <FIG>). Upon receiving an indication that the tension limit has been reached, the trim system may be configured to cause the cutting blade <NUM> to be activated to cut the excess portion of the tail <NUM>. The trim system and the cutting blade <NUM> may be configured to cut the tail <NUM> to avoid the creation of any jagged edges at the cut end. Jagged edges may cause pain and/or discomfort for a patient. A band <NUM> may be fed through the channel <NUM> (see <FIG>) so that a perpendicular relationship may be maintained between the band <NUM> and the cutting blade <NUM> to ensure a clean and straight cut with no jagged edges. The cutting blade <NUM> may be slightly curved or radially shaped to avoid any sharp edge on the end of the tail <NUM> from extending through the exit <NUM> (see <FIG>) of the head <NUM> of a band to prevent soft tissue irritation.

Once assembled, the fixation plate may be positioned at the sternum above a cut on the sternum, and bands may be looped around to urge severed halves of the sternum together. <FIG> illustrates a front view of an example fixation plate <NUM> assembled at a sternum <NUM>, and <FIG> illustrates a perspective view of the fixation plate <NUM> of <FIG> assembled at the sternum <NUM>. As illustrated, the fixation plate <NUM> may be positioned adjacent to the sternum <NUM>, and bands <NUM> may be wrapped around the sternum <NUM> and secured in a loop. A band <NUM> may proceed through the intercostal spaces <NUM> formed between two ribs <NUM> on one side of the sternum <NUM>. After that, the band <NUM> may be wrapped around the rear of the sternum <NUM> so that the band <NUM> may proceed through an intercostal space <NUM> on the opposite side of the sternum <NUM>. The band <NUM> may then be inserted into the internal cavity in head of the band <NUM> so that a loop may be formed. Alternatively, instead of wrapping the bands <NUM> around the sternum <NUM>, a pilot hole may be created in the sternum <NUM> where the bands <NUM> may be inserted, and the bands <NUM> may form a loop extending through the pilot hole.

The bands <NUM> illustrated in <FIG> are provided in a level manner, with the bands <NUM> proceeding through corresponding intercostal spaces <NUM> on opposite sides of the sternum <NUM>. However, the bands <NUM> may be installed in other ways, with the bands <NUM> extending diagonally. For example, some may find it desirable to install two bands <NUM> in an X-pattern. Further, bands <NUM> are provided with only one band <NUM> inserted in each intercostal space <NUM>, but additional bands <NUM> may be provided in a single intercostal space <NUM> in other embodiments. Additionally, as shown in <FIG>, more than one head may be received in a single window <NUM> of the fixation plate <NUM>. In <FIG>, one head is received in the top window <NUM>, two heads are received in the middle window <NUM>, and one head is received in the bottom window <NUM>. In other embodiments, only one head may be received in each window <NUM>, or additional heads may be inserted into a single window.

While <FIG> show the fixation plate and bands installed on a sternum, a tensioning gun may be used to improve the installation process for the fixation plate and bands. <FIG> illustrates a perspective view of an example tensioning gun <NUM> being used to assist in securing an example fixation plate <NUM> to the sternum of a patient.

Similar to the bands and fixation plates discussed above, the bands <NUM> may be inserted through intercostal spaces <NUM> between ribs <NUM> of the patient to form a loop, and the head of these bands <NUM> may be installed at a fixation plate <NUM>. The end of the bands <NUM> may be inserted into a tensioning gun <NUM>, and the tensioning gun <NUM> may apply tension to the bands until a tension limit has been reached. In the illustrated embodiment, gripping jaws <NUM> and a travel limiter 1725A are provided. The gripping jaws <NUM> may pull on the band <NUM> and tighten the band <NUM> to a predetermined tension associated with placement of the travel limiter 1725A. However, in other embodiments, other mechanisms may be provided to apply tension to the band <NUM> and/or the tension limit may be implemented without using a travel limiter 1725A. Upon the tension limit being reached, the amount of tension applied by the tensioning gun <NUM> may be maintained. With the tension at this level, the trim system <NUM> (see <FIG>) within the tensioning gun <NUM> may cause the cutting blade <NUM> (see <FIG>) to cut the excess portion of the band <NUM>. In some embodiments, the bands <NUM> may be provisionally tensioned after the bands <NUM> are formed into loops. Where provisional tensioning is performed, the loops formed by the bands <NUM> may be tightened to some degree while still leaving some slack in the loops. By provisionally tensioning bands, proper positioning of the severed halves of the sternum, the fixation plate <NUM>, and the bands <NUM> may be ensured before tension is applied via the tensioning gun <NUM>. However, in other embodiments, provisional tensioning may not be performed. Tensioning of the bands <NUM> with the tensioning gun <NUM> may simultaneously compress the fixation plate <NUM> and bone components together to effectively form a splint that may provide adequate stability for healing. The fixation plate <NUM> may provide sufficient stiffness and rigidity to buttress the injured bone while providing sufficient ductility to conform to the shape and contours of the underlying bone (e.g. the sternum) upon the tensioning of the bands <NUM>.

Skipping ahead to <FIG>, an alternative tensioning gun <NUM> is illustrated. The tensioning gun <NUM> may take on the form of a "trigger-pull" shape similar to a handgun. The tensioning gun <NUM> may include a rotatable knob <NUM> on the body <NUM> of the tensioning gun <NUM>, and the rotatable knob <NUM> may be located on the end of the tensioning gun <NUM> opposite the aperture <NUM>. The tensioning gun <NUM> may include a handle <NUM> and an actuator lever <NUM>. When twisted, the rotatable knob <NUM> may operate to adjust the tension setting such that a desirable amount of tension may be generated in a band <NUM> when a user depresses the actuator lever <NUM>. Further, a switch <NUM> may also be included. The switch <NUM> may enable the tensioning gun <NUM> to alternate between a tensioning mode and a cutting mode. Where the switch <NUM> is in a tensioning mode, the tensioning gun <NUM> may tighten the band <NUM> being fed through the aperture <NUM> on the distal end of the barrel <NUM> when a user squeezes and depresses the actuator lever <NUM>. Once the tension in band <NUM> reaches a desirable or pre-determined level, the switch <NUM> may be used to change from the tensioning mode to the cutting mode. In the cutting mode, a user may depress the actuator lever <NUM> to cut the tensioned band <NUM>. The resulting band <NUM> may be neatly flush to or beneath the top surface of a head <NUM> (see <FIG>).

Looking now at <FIG>, another alternative tensioning gun <NUM> is illustrated. The tensioning gun <NUM> may take the form of a "linear-pull" mechanism shaped similarly to a syringe. In such an embodiment, the actuator lever <NUM> may take on a more linear movement profile, and the actuator lever <NUM> may function to tension a band <NUM> when the user pulls the actuator lever <NUM> backwards along a slider track <NUM> in a direction away from the aperture <NUM>. The slider track <NUM> may be provided on the barrel <NUM> of the body <NUM> for the actuator lever <NUM>. Once the band <NUM> reaches the tension limit, a switch <NUM> may be utilized to switch the tensioning gun <NUM> from a tensioning mode to a cutting mode. In the cutting mode, the user may cut the tensioned band <NUM> by pulling the actuator lever <NUM> back along the slider track <NUM>, and the resulting band <NUM> may be neatly flush to or beneath the top surface of a head <NUM> (see <FIG>). The tensioning gun <NUM> illustrated in <FIG> may be a highly intuitive tool, and it may be a disposable, single-use tool in some embodiments. However, the tensioning gun <NUM> and other tensioning guns provided herein may be durable tools that may be intended for repeated use in other embodiments.

The actuator lever <NUM> of <FIG> and the actuator lever <NUM> of <FIG> may be configured to cause both the actuation of the cutting blade and the application of tension to the band, and the switch <NUM>, <NUM> may be used to control the mode that the actuator lever is in. However, tensioning guns may switch between a cutting mode and a tensioning mode in other ways in other embodiments. For example, the tensioning gun may alternate between the tensioning mode and the cutting mode each time that the actuator lever is compressed. In some embodiments, the tensioning gun may only be used to apply tension up to a tension limit, and another cutting tool may be deployed to cut a band upon the tension limit being reached.

<FIG> provide another illustration of the fixation plate being installed at a cut sternum to assist in restricting two severed halves of the cut sternum. <FIG> illustrates a perspective view of an example fixation plate being positioned against a cut sternum. <FIG> illustrates a perspective view of the fixation plate of <FIG> with a band being assembled to the fixation plate, in accordance with some embodiments discussed herein. <FIG> illustrates a perspective view of the fixation plate of <FIG> with a tensioning gun being used to tension and cut bands, in accordance with some embodiments discussed herein.

As illustrated in <FIG>, the sternum <NUM> may include a cut <NUM>, and two severed halves of the sternum <NUM> may be provided on opposite sides of the cut <NUM>. With the two severed halves of the sternum <NUM> being adjusted to the appropriate position, the fixation plate <NUM> may be provided at the sternum <NUM> above the cut <NUM>. As illustrated in <FIG>, a spring <NUM> may be provided at the fixation plate <NUM>, and the spring <NUM> may assist in urging the fixation plate <NUM> against the sternum <NUM> to conform the shape of the fixation plate <NUM> to the shape of the sternum <NUM>. Manubrial extensions may be provided in the fixation plate <NUM> at the upper portion of the fixation plate <NUM> to enable the fixation plate <NUM> to easily conform to features at the manubrium of the sternum. Furthermore, the spring <NUM> may have small wires that may extend through small holes in the sternum. These wires may extend from the top side of the sternum through the sternum to the bottom side of the sternum, and the wires may form a loop that may be tightened at the bottom side of the sternum. The head of a band <NUM> may be installed within a window within the fixation plate <NUM>, and the band <NUM> may be wrapped around the sternum <NUM> through intercostal spaces <NUM> between the ribs <NUM> of a patient to form a loop as described herein. This band <NUM> may be wrapped around using instruments as illustrated in <FIG>, but this may instead be done by hand in other embodiments. Furthermore, as illustrated in <FIG>, a tensioning gun <NUM> may be used to apply tension to the bands <NUM> and to remove excess portions of the bands <NUM>. Tensioning of the bands <NUM> may simultaneously compress the fixation plate <NUM> and bone components together to effectively form a splint that may provide adequate stability for healing. The fixation plate <NUM> may provide sufficient stiffness and rigidity to buttress the injured bone while providing sufficient ductility to conform to the shape and contours of the underlying bone (e.g. the sternum) upon the tensioning of the bands <NUM>. The fixation plate <NUM> may disperse stress over a larger surface area of the bone components than the bands <NUM> applied by themselves.

In some embodiments, a surgical drain assembly may be provided alongside a fixation plate. Surgical drain assemblies may be beneficial in open heart procedures with sternotomy, but the surgical drains may be used for other procedures and may be used alongside bones other than the sternum. Surgical drain assemblies may remove excess fluid such as blood that may collect near a surgical site. If excess fluid is not removed, this excess fluid may become infectious posing serious risk to the health of the patient while retarding or preventing recovery. Surgical drains may be provided on a temporary basis in some embodiments, and the surgical drains may be removed once the surgical site has sufficiently healed.

<FIG> illustrates a bottom view of an example surgical drain assembly <NUM>, <FIG> illustrates a side view of the surgical drain assembly <NUM>, and <FIG> illustrates a schematic view of the surgical drain assembly <NUM> of <FIG> having an internal cavity <NUM>. As illustrated in <FIG>, the surgical drain assembly <NUM> may include a drain body <NUM>. The drain body <NUM> may generally have a similar shape to a fixation plate that the drain body <NUM> is being used with in some embodiments. However, the drain body <NUM> may differ in size and/or shape from the fixation plate in other embodiments. The drain body <NUM> is configured to have a similar size and shape as the fixation plate <NUM> of <FIG> so that the drain body <NUM> may easily be attached to the fixation plate <NUM>.

The drain body <NUM> may include protrusions <NUM> extending downwardly from a bottom surface of the drain body <NUM>. The protrusions <NUM> may be configured to engage with a portion of the windows <NUM> of the fixation plate <NUM> (see <FIG>) to restrict the movement of the drain body <NUM> relative to the fixation plate <NUM>. The protrusions <NUM> may form a press fit with a portion of the windows <NUM>, but the drain body <NUM> may be restrained relative to the fixation plate <NUM> in other ways. While the protrusions <NUM> generally match the shape of the windows <NUM> of the fixation plate <NUM>, the protrusions <NUM> and other features on the drain body <NUM> may be configured to match the features of another fixation plate <NUM> in other embodiments. For example, contoured sections may be provided in the drain body <NUM>, or additional protrusions may be provided.

The drain body <NUM> may be configured to be placed above a fixation plate <NUM> (see <FIG>) resting on a sternum <NUM> (see <FIG>). Extension tubes <NUM> may connect to the drain body <NUM>, and the extension tubes <NUM> may extend around to the opposite side of the sternum <NUM>. The extension tubes <NUM> may be wrapped through intercostal spaces <NUM> (see <FIG>) between adjacent ribs <NUM> (see <FIG>) of the patient. The extension tubes <NUM> may collect excess fluid at locations behind the sternum <NUM> where excess fluids tend to collect, and this excess fluid may flow through the extension tubes <NUM> to an internal cavity <NUM> within the drain body <NUM>. The drain body <NUM> and the extension tubes <NUM> may comprise soft and flexible material and may comprise an approved implant material such as silicone.

Placement of the drain body <NUM> above the fixation plate may be beneficial for various reasons. Placement of the drain body <NUM> at this position may permit the drain body <NUM> to be easily installed and easily removed. To the extent one desires to remove the surgical drain assembly <NUM>, the drain body <NUM> may be simply removed by gently prying the protrusions <NUM> free from the fixation plate <NUM>. This may effectively decouple the drain body <NUM> and the fixation plate <NUM>. This removal of the drain body may be done using surgical instruments. Once the drain body <NUM> and the fixation plate <NUM> are decoupled, the surgical drain assembly <NUM> may be removed from the body of the patient by shifting the surgical drain assembly <NUM> through a small incision where the drainage tube <NUM> exits though the skin. Notably, positioning of the drain body <NUM> above the sternum <NUM> (see <FIG>) permits easy removal - if the drain body <NUM> were installed behind the sternum <NUM>, removal of the drain body <NUM> is made more difficult. To remove a drain body <NUM> installed behind the sternum <NUM>, one would need to grasp the drain body <NUM> (which is positioned in a hard to reach location behind the sternum <NUM>), maneuver the drain body <NUM> through an intercostal space <NUM> (see <FIG>) between the ribs <NUM> (see <FIG>), and then maneuver the drain body <NUM> to an incision in the skin of the patient where the drain body <NUM> may be removed. Such an approach would be more difficult and would potentially require a larger incision to better enable one to remove the drain body <NUM>. Furthermore, installation and removal of a drain body <NUM> at a position behind the sternum <NUM> may be problematic due to the presence of other organs located behind the sternum <NUM>. By placing the drain body <NUM> above the sternum <NUM>, these issues may be avoided, and smaller extension tubes <NUM> may be more easily wrapped around through the intercostal spaces <NUM> (see <FIG>) to capture excess fluid from behind the sternum <NUM>.

Fluid may be retained in the internal cavity <NUM> until it is removed via a drainage tube <NUM>. This drainage tube <NUM> may be provided at or proximate to the bottom of the drain body <NUM> when the drain body <NUM> is in an upright position (e.g. when the patient is standing up). Thus, the force of gravity may urge fluids in the drain body <NUM> to flow to the drainage tube <NUM> where they may be removed. However, in some embodiments, multiple drainage tubes <NUM> may be connected to the drain body <NUM>. Additionally, drainage tubes <NUM> may be provided at other locations on the drain body <NUM>. In some embodiments, the drainage tube <NUM> may extend to an external environment from within the body of the patient, passing through layers of flesh.

The force of gravity may be relied on exclusively in some examples to urge fluids to the drainage tube <NUM>. However, in other examples, a negative pressure device may be utilized to urge fluid to and through the drainage tube <NUM>. The negative pressure device may also tend to urge fluid through any openings <NUM> (see <FIG>) in the drain body <NUM>, and the negative pressure device may tend to urge fluid through the extension tubes <NUM> so that fluid may flow into the internal cavity <NUM> and out of the drainage tube <NUM>. A negative pressure device (manually or mechanically actuated) can be attached to the free end of the drainage tube <NUM>. This negative pressure device may create suction throughout the surgical drain assembly <NUM> to assist in the removal of excess fluid. In some examples, manually actuated negative pressure devices such as syringes or hand pumps may be used. Negative pressure does not rely of gravity feed to remove excess fluid, so the negative pressure device may permit excess fluid removal while the patient is resting, for example, in a supine position. However, the negative pressure device may be used in conjunction with gravitational forces to remove excess fluid in some examples Alternatively, an inlet tube may be provided, and a positive pressure device may be installed at the inlet to urge excess fluid towards the drainage tube <NUM> and out of the surgical drain assembly <NUM>.

While the drain body <NUM> of <FIG> includes protrusions <NUM> to assist in restraining the drain body <NUM> relative to a fixation plate, other approaches for restraining these two components are also contemplated. For example, <FIG> illustrates an enhanced view of an example drain body <NUM> of a drainage assembly <NUM> having suture holes <NUM>. Suture holes <NUM> may be provided on the drain body <NUM> and the fixation plate, and the drain body <NUM> and the fixation plate may be stitched together using the suture holes <NUM>. Suture holes <NUM> may be provided generally parallel to the lateral edges of the fixation plate. A surgical suture may extend through the suture holes <NUM> to bind the drain body <NUM> and a fixation plate <NUM> (see <FIG>) together, and the surgical suture may eventually be knotted and/or cut. However, other fasteners may be used. In some examples, multiple surgical sutures may be used to provide increased security. In some examples, the surgical sutures and suture holes <NUM> may be used instead of the protrusions <NUM> to attach the drain body <NUM> and fixation plate <NUM> together, but these different approaches could be used simultaneously to provide further security in some examples Additionally, in other examples, the fixation plate and the drain body <NUM> may form one integral part.

Extension tubes may be used to provide obtain excess fluid, but the drain body may also include openings where fluid may flow through to enter the internal cavity of the drain body. <FIG> illustrates an enhanced view of an example drain body <NUM> having a plurality of openings <NUM> in the surface of the drain body <NUM>. Openings <NUM> having larger or smaller sizes may be used in other embodiments. Furthermore, while the openings <NUM> are illustrated as having a circular shape in <FIG>, the openings <NUM> may have other shape in other embodiments (e.g. rectangular slits, oval shaped, asymmetrically shaped, etc.). Openings <NUM> may be provided on the top surface of the drain body <NUM> so that fluid at the fixation plate may flow through the windows or other gaps to the openings <NUM> so that the fluid may enter into the internal cavity <NUM>. Additionally, openings <NUM> may be provided on other surfaces of the drain body <NUM> and/or extension tubes <NUM>. Suction or other forces applied at an inlet tube or a drainage tube may tend to urge excess fluid through the openings and into the internal cavity of the drain body <NUM>. The openings <NUM> may be positioned on the drain body <NUM> to receive fluid when a user is lying down, but similar openings may be provided at other locations on the drain body <NUM> to receive fluid when the user is standing up.

While the surgical drain assembly <NUM> may be used primarily as a drain in some embodiments, it may additionally or alternatively be used to introduce antiseptic and/or other fluids to post-operatively flush the surgical site. In addition, medications may be introduced to a surgical site post-operatively using the surgical drain assembly <NUM>. For example, an inlet tube (see, e.g., <NUM>, <FIG>) may be provided where medications may be introduced, and positive pressure may be generated by gravity, a syringe, a hand pump, or some other device to urge the medications towards the surgical drain assembly and the surgical site. Positive pressure for introducing fluids may be generated by gravity feed such as an elevated IV bag or via a syringe or hand pump or a mechanical device. The introduced medication fluid may eventually be removed with the application of a negative pressure (manual or mechanical) device applied at the drainage tube <NUM> or gravity feed. Additionally or alternatively, some or all of the surgical drain assembly <NUM> (e.g. the surface of the drain body <NUM>) may be coated with antimicrobial agents that release into the surrounding in-vivo environment.

Looking now at <FIG>, another example embodiment of a drain assembly <NUM> is illustrated. <FIG> illustrates a bottom view of the drain assembly <NUM>, and <FIG> illustrates a top view of the drain assembly <NUM>. The drain assembly <NUM> may include a drain body <NUM>. The drain body of <FIG> may generally match the shape of the sternum for a patient. The drain body <NUM> may include one or more protrusions <NUM> that extend downwardly from the bottom surface of the drain body <NUM>. The protrusions <NUM> may be configured to engage with a portion of the windows <NUM> of the fixation plate <NUM> (see <FIG>) to restrict the movement of the drain body <NUM> relative to the fixation plate <NUM>. The protrusions <NUM> may form a press fit with a portion of the windows <NUM>, but the drain body <NUM> may be restrained relative to the fixation plate <NUM> in other ways. For example, protrusions may be provided on the drain body <NUM> that are configured to engage with the outer perimeter of the fixation plate <NUM>. Additional protrusions may be provided on the bottom surface of the drain body <NUM> that are configured to engage with the sternum itself, and these protrusions may extend at least partially into intercostal spaces <NUM> (see <FIG>) between the ribs <NUM> (see <FIG>) of the patient to assist in positioning the drain body <NUM>. Similar to the drain assembly of <FIG>, the drain assembly <NUM> in <FIG> and <FIG> may include extension tubes <NUM>. However, a drain assembly may be provided without extension tubes in some embodiments. The extension tubes <NUM> may extend into intercostal spaces <NUM> between the ribs <NUM> of the patient so that the extension tubes <NUM> reach the area behind the sternum of the patient where excess fluid tends to collect. The extension tubes <NUM> may be pre-bent or curved at a pre-determined radius. This may help facilitate maneuverability of the bands <NUM> through and under the intercostal spaces <NUM> and under the posterior surface of the sternum. The extension of extension tubes <NUM> into the intercostal spaces <NUM> may aid in the positioning of the drain body <NUM>. The drain assembly <NUM> may also include an inlet tube <NUM> and a drainage tube <NUM>.

While various examples described herein illustrate or describe the use of the fixation plate, bands, the tensioning device, and/or the drain assembly with a severed sternum, these components may be used with other bones in the human body, or these components may be used for bones of an animal. The fixation plate and bands described herein may be formed from any polymeric material known in the art. The polymeric material should preferably have some rigidity and some flexibility. In an embodiment, the polymeric material used to form the fixation plate and/or the bands may comprise polyether ether ketone (PEEK). The polymeric material may be thermoformed, 3D printed, or formed using any other method known in the art. Additionally, the drain assembly may comprise a variety of materials. Drain assemblies may comprise an elastic material in some embodiments that may be easily conformed to the shape of the sternum. For example, the drain assembly may comprise a silicone, another soft rubber based material, or a polymeric material such as PEEK. The material in the drain assemblies may be porous on some or all sides so that excess fluid may enter into the drain assembly through the material, and suction may be applied to the drain assembly to urge excess fluid into the drain assembly through the porous material.

While various apparatuses and assemblies are provided, methods (not claimed) for using these apparatuses and assemblies are also contemplated. <FIG> illustrates an example method for installing a fixation plate and a drainage assembly to a severed sternum, in accordance with some embodiments discussed herein. At operation <NUM>, a tensioning gun, a fixation plate, bands, and a surgical drain assembly may be provided. In some examples, these components may not be provided. For example, where a user desires to install the fixation plate without any surgical drain assembly, the surgical drain assembly may be omitted.

At operation <NUM>, a fixation plate and a drain body of the surgical drain assembly may be attached. The fixation plate and the drain body may be attached together to increase the ease of installation on the severed sternum. By attaching these components together, fewer moving parts may exist during installation.

At operation <NUM>, the fixation plate and the drain body may be placed on the severed sternum above the cut. The fixation plate may be positioned on the sternum with the drain body positioned above the fixation plate. The two severed halves of the severed sternum may need to have their positions adjusted before placement of the fixation plate and drain body to ensure proper healing.

At operations <NUM>-<NUM>, bands may be applied and tensioned. At operation <NUM>, bands may be applied to the fixation plate. This may be done by placing a portion of the bands (e.g. the head) within windows of the fixation plate so that the movement of the bands may be restricted relative to the fixation plate. The end of the tail of a band may be inserted into an internal cavity at the head of the band so that a loop is formed. At operation <NUM>, bands may be provisionally tensioned. This provisional tensioning may be done by hand or some other instrument. Multiple bands may be applied and provisionally tensioned to ensure that the fixation plate and bands are positioned appropriately before performing any final tensioning. At operation <NUM>, final tensioning may be applied to the bands. This final tensioning may be performed using the tensioning gun. The tensioning gun may be configured to apply tensioning until the tension within the band reaches a tension limit, and the tensioning gun may cease applying further tension to the bands once this tension limit is reached. Alternatively, the tensioning may continue being applied at the same tension level proximate to the tension limit. until the bands are cut at operation <NUM>. At operation <NUM>, the bands may be cut. Where the tensioning gun is used, the bands may be cut automatically upon the desired tension level being reached within a band.

The operations of <FIG> may be performed in any order unless otherwise noted. For example, Furthermore, the operations of <FIG> may be performed simultaneously in some examples. For example, operations <NUM> and <NUM> may be performed simultaneously where a tensioning gun is used to simultaneously perform final tensioning and cutting, and this may be beneficial to increase the ease of installation as it reduces the number of separate tasks that need to be performed by the installer. Additionally, certain operations of <FIG> may be omitted or certain operations may be added to <FIG>. For example, no drain body is provided at operation <NUM> and only a fixation plate may be provided instead. In other examples, provisional tensioning is not performed and the user may simply apply final tensioning at operation <NUM>.

In some embodiments, fixation plates may be provided with additional holes configured to receive further fasteners, and this may be beneficial to cause the fixation plate to further conform to the shape of the underlying bone. <FIG> illustrates a fixation plate <NUM> with holes <NUM> provided within rails <NUM>. These holes <NUM> are configured to receive fasteners, and these fasteners may extend through the holes <NUM> and engage a bone. By engaging a bone, fasteners may assist in attaching the fixation plate <NUM> to the underlying bone. Fasteners may also assist in forcing the fixation plate <NUM> to change in shape to conform to the shape of the underlying bone. Fasteners inserted through holes <NUM> may include screws, wires, sutures, cables, etc. Holes <NUM> may be threaded in some embodiments, but the holes <NUM> may be provided without any threading in other embodiments. Furthermore, in some embodiments, the holes <NUM> may be configured to receive a fastener in the form of a wire, and the wire may be inserted into a bone to restrict movement of the fixation plate. Alternatively, the wire could simply be wrapped around a bone to further aid in restricting movement of the fixation plate. By providing holes <NUM>, additional fasteners may be received in the holes to reduce the amount of forces acting on each individual fastener and on any bands that are attached to the fixation plate <NUM>, and this may reduce the likelihood of failure in the bands and fasteners. The fixation plate <NUM> may possess other features of the various embodiments of fixation plates described herein and illustrated in the drawings.

In various embodiments, a head of a band may passively engage windows formed in a fixation plate, and movement of the band out of the windows may be at least partially restricted once tension is applied to the band. <FIG> illustrate examples of such passively engaging heads. <FIG> illustrates a top perspective view of a head <NUM> of a band <NUM> that is passively engaged with a fixation plate <NUM>, and <FIG> illustrates a bottom view of a head <NUM> of a band <NUM> that is passively engaged with a fixation plate <NUM>. As illustrated, bands <NUM> may be provided having a head <NUM> and a tail <NUM>. The head <NUM> is passively engaged with windows <NUM> formed in the fixation plate <NUM>. As illustrated in the bottom view of <FIG>, the bottom portion <NUM> may simply rest within the window <NUM> - this may be done without any protruding portion 626A (see <FIG>) extending from the rails <NUM> into the window, and this may be done without any bottom lock <NUM> (see <FIG>) being provided on the bottom portion <NUM>. When the band <NUM> has not been tightened, the bottom portion <NUM> is configured to be easily removed from the window <NUM> with minimal interference. However, when the band <NUM> has been tightened around a bone or some other object, tension forces may act on the band <NUM> and urge the head <NUM> of the band <NUM> downwardly into the windows <NUM>. This downward force acting on the head <NUM> of the band <NUM> will retain the head <NUM> of the band <NUM> within the windows <NUM>. In some instances, the head <NUM> of the band <NUM> may still be able to slide along the windows <NUM> after tensioning. However, in some instances, the downward force acting on the head <NUM> may cause a significant amount of friction between the head <NUM> and the fixation plate <NUM>, and this friction may wholly prevent or partially restrict the movement of the head <NUM> along a window <NUM>.

<FIG> and <FIG> illustrate further views of the head <NUM> where the bottom portion <NUM> may be seen in more detail. <FIG> illustrates a top perspective view of the head <NUM> of the band <NUM> of <FIG>, and <FIG> illustrates a bottom perspective view of the head <NUM> of the band <NUM> of <FIG>. The illustrated band <NUM> has a tail <NUM> and a head <NUM>, and an bottom portion <NUM> is provided at the bottom of the head <NUM>. The bottom portion <NUM> includes circular shape, but other shapes may be provided. Notably, the bottom portion <NUM> does not include any sort of bottom lock (see, e.g., bottom lock <NUM> of <FIG>, bottom lock <NUM> of <FIG>) or any tabs extending radially from the center of the bottom portion <NUM>. Thus, where no other forces are acting on a head <NUM>, the bottom portion <NUM> of the head <NUM> may be easily raised and lowered out of the windows <NUM> without any significant interference between the bottom portion <NUM> and the rails <NUM>.

In <FIG> and <FIG>, the bottom portion <NUM> is configured to permit rotation of the band <NUM> relative to a fixation plate <NUM>. As illustrated in <FIG>, the bottom portion <NUM> generally possesses a circular shape. With this shape, the bottom portion <NUM> may be inserted into the window <NUM> (see <FIG>). When received in the window <NUM>, the circular shaped bottom portion <NUM> may be configured to permit rotation of the band <NUM> relative to the fixation plate <NUM> when the amount of tension applied in the band <NUM> is low. However, when a high amount of tension is applied to the band <NUM>, the ability of the band <NUM> to rotate relative to the fixation plate <NUM> may be partially or wholly restricted. The use of circular shaped bottom portions <NUM> may be advantageous to provide increased flexibility while assembling the band <NUM> to the fixation plate <NUM>. While a circular shaped bottom portion <NUM> is provided as one example of an bottom portion that is configured to rotate, the bottom portion may still rotate when possessing other shapes (depending on the shape of the window that the bottom portion is being received in).

<FIG> illustrates a bottom view of the fixation plate <NUM> of <FIG>. As illustrated, the fixation plate <NUM> may include rails <NUM> running along the sides of the fixation plate <NUM>. Windows <NUM> may be formed in spaces between the rails <NUM>. In the fixation plate <NUM> of <FIG>, the windows <NUM> may be formed without any protruding portion 626A (see <FIG>) that extends into the windows <NUM>. Thus, where no other forces are acting on a head <NUM>, the bottom portion <NUM> of the head <NUM> may be easily raised and lowered out of the windows <NUM> without any significant interference between the head <NUM> and the rails <NUM>.

According to the invention bands are provided having passively engaging heads that are configured to restrict rotation of bands relative to a fixation plate. <FIG> illustrates a top perspective view of a head <NUM> of a band <NUM> that is passively engaged with a window <NUM> of a fixation plate <NUM>, and <FIG> illustrates a bottom view of a head <NUM> of a band <NUM> that is passively engaged with a window <NUM> of a fixation plate <NUM>. As illustrated, the fixation plate <NUM> may include rails <NUM> running along the sides of the fixation plate <NUM>. Windows <NUM> may be formed in spaces between the rails <NUM>. The bands <NUM> have a head <NUM> and a tail <NUM>.

In <FIG>, the bottom portion <NUM> is configured to restrict rotation of the band <NUM> relative to the fixation plate <NUM>. As illustrated in <FIG>, the bottom portion <NUM> generally possesses a square shape. With this shape, the bottom portion <NUM> may be inserted into the window <NUM>. When received in the window <NUM>, the square shaped bottom portion <NUM> may be configured to restrict rotation of the band <NUM> relative to the fixation plate <NUM> - an attempt to rotate the square shaped bottom portion <NUM> in a clockwise or counterclockwise direction will result in contact between the edges of the bottom portion <NUM> and the rails <NUM>.

Further views of the square shaped bottom portion <NUM> in isolation are provided in <FIG> and <FIG>. <FIG> illustrates a bottom perspective view of the head <NUM> of the band <NUM>, and <FIG> illustrates a top perspective view of the head <NUM> of the band <NUM>. Fillets may be provided at the corners of the square shaped bottom portion <NUM>, and the fillets may reduce the likelihood of stress concentrations at the corners of the bottom portion <NUM>. While the square shaped bottom portion <NUM> is illustrated, the bottom portion <NUM> may possess other shapes. For example, where it is desirable to use a band <NUM> having an bottom portion that is configured to restrict rotation of the band <NUM>, bottom portions may possess a triangular shape, rectangular shape, a pentagonal shape, a hexagonal shape, an octagonal shape, a star shape, a polygonal shape, an asymmetrical shape, or some other non-circular shape. The band <NUM> may be configured so that the band <NUM> will not slip, move, or change position due to the passive engagement of the head <NUM>.

In some embodiments, the head may possess a bottom lock that possesses a cam shape. The head may be restricted from moving out of the windows at one rotational orientation, and the head may be permitted to move out of the windows at another rotational orientation.

<FIG> and <FIG> illustrate the head having a cam shaped bottom lock in isolation. <FIG> illustrates a bottom perspective view of the head <NUM> of <FIG>. <FIG> illustrates a bottom view of the head <NUM> of <FIG>. The cam shaped bottom lock <NUM> may possess an enlarged portion 2667A and reduced portions 2667B. The enlarged portion 2667A may take the form of winged tabs. The edges of the enlarged portion 2667A may extend farther away from the center of the cam shaped bottom lock than the edges of the reduced portions 2667B. A lip <NUM> may be formed at the enlarged portions 2667A, and a fixation plate <NUM> (see <FIG>) may be retained between the lip <NUM> and the upper portions of the head <NUM>. As illustrated in <FIG>, the band <NUM> may also have a tail <NUM>.

<FIG> illustrate an example of such a head <NUM> interacting with a fixation plate <NUM>. <FIG> illustrates a bottom view of a head <NUM> of a band <NUM> that includes a cam shaped bottom lock <NUM> in an open position relative to a fixation plate <NUM>. <FIG> illustrates another bottom view of the head <NUM> in a closed position relative to the fixation plate <NUM>. The fixation plate <NUM> possesses protruding portions 626A (see <FIG>) that extend into the windows <NUM>, and these protruding portions 626A may assist in engaging an enlarged portion 2667A of the bottom lock <NUM>. The cam shaped bottom lock <NUM> may be received in a window <NUM> of the fixation plate <NUM>. This may be done with the cam shaped bottom lock <NUM> oriented such that the enlarged portion 2667A will not interfere with the fixation plate <NUM>. Once the bottom lock <NUM> is received within the window <NUM>, the bottom lock <NUM> may be rotated so that the enlarged portions 2667A of the bottom lock <NUM> come in contact with the fixation plate <NUM> as illustrated in <FIG>. Contact between the enlarged portions 2667A and the fixation plate <NUM> will prevent the band <NUM> from moving out of the windows <NUM>. In some embodiments, contact between the enlarged portions 2667A and the fixation plate <NUM> may generate friction to at least partially restrict movement of the bands <NUM> along the length of the windows <NUM> (e.g. up and down in <FIG>). In some embodiments, this friction may be large enough to effectively lock the band <NUM> in place relative to the fixation plate <NUM>. The bottom lock <NUM> may be rotated by ninety (<NUM>) degrees in a clockwise or counterclockwise direction to lock and/or unlock the head <NUM> relative to the fixation plate <NUM> in some embodiments. The cam shaped bottom lock may possess a variety of shapes. For example, the cam shaped member may possess an oval shape, a polygonal shape, an asymmetrical shape, etc. The bottom lock <NUM> illustrated in <FIG> and <FIG> may act as a cam shaped bottom lock, and this bottom lock <NUM> may function similarly to the bottom lock <NUM>.

While various embodiments provide fixation plates having windows configured to allow a head of a fastener to slide along the windows, other fixation plates (not claimed) are contemplated having windows that do not permit the head of a fastener to slide. <FIG> illustrate two such embodiments. <FIG> illustrates a top view of a fixation plate <NUM> with circular windows <NUM>. <FIG> illustrates a top view of a fixation plate <NUM> with square windows <NUM>.

Looking first at <FIG>, the circular windows <NUM> may receive a portion of a head of a band. The circular windows <NUM> are configured to restrict translatory movement of the head of the band in a lengthwise direction along the fixation plate <NUM> (e.g. left and right in <FIG>) or in a traverse direction (e.g. up and down in <FIG>). Thus, the head may be locked in position in this regard. However, circular windows <NUM> may be configured to permit the head of a band <NUM> received therein to rotate relative to the fixation plate <NUM>. This rotational movement of the head of the band <NUM> may be beneficial to permit bands <NUM> to be rotated as necessary so that the band <NUM> may extend into an intercostal space <NUM> (see <FIG>) between ribs <NUM> (see <FIG>).

Looking now at <FIG>, the square windows <NUM> of the fixation plate <NUM> may receive a portion of a head of a band. The square windows <NUM> are configured to restrict translatory movement of the head of the band in a lengthwise direction along the fixation plate <NUM> (e.g. left and right in <FIG>) or in a traverse direction (e.g. up and down in <FIG>). Thus, the head may be locked in position in this regard. Furthermore, depending on the shape of an bottom portion or a head of a band, the square windows <NUM> may be configured to prevent the head of a band received therein from rotating relative to the fixation plate <NUM>. For example, where an appropriately sized head having a square shaped bottom portion <NUM> (see <FIG>) is received in a square window <NUM>, this may prevent translatory movement and rotational movement of the head. While the square windows <NUM> are illustrated, the windows may possess other shapes. For example, windows may possess a triangular shape, rectangular shape, a hexagonal shape, a star shape, a polygonal shape, an asymmetrical shape, or some other non-circular shape. The windows may be designed to generally match the shape of the bottom portion of a corresponding head.

Claim 1:
A plate assembly for stabilizing a bone, comprising:
a fixation plate (<NUM>) having rails (<NUM>) that form a window (<NUM>), wherein the window possesses an elongate shape;
a band (<NUM>) having:
a tail (<NUM>); and
a head (<NUM>) defining an internal cavity being configured to receive a portion of the tail, wherein the head includes a bottom portion (<NUM>), and wherein the bottom portion is configured to be passively received within the window of the fixation plate,
wherein the fixation plate is configured to be positioned proximate to a bone, wherein the head is configured to be at least partially received at the fixation plate between the rails within the window, wherein the band is configured to be wrapped around the fixation plate and the bone, wherein the internal cavity of the head is configured to receive an end of the tail to form a loop, wherein the band is configured to receive a tension force to tighten the loop formed by the band, and wherein the elongate shape of the window is configured to permit the head to slide along the window.