Patent Description:
The present disclosure relates to surgical systems. Specifically, the present disclosure relates to assemblies and methods used in a craniotomy.

For certain neuro surgical procedures, a section of the skull is removed to access the brain. This section, known as a bone flap, allows surgeons access to the brain for treating tumors or trauma to the brain. Once a portion of the skull, known as a bone flap, is separated from the skull, it is placed at a sterile area while the surgeon operates on the brain. Upon completion of the procedure, the bone flap is replaced and secured to the skull.

To facilitate creation of the bone flap, one or more burr holes can be created. The burr holes provide a location for a surgeon to insert a saw or other cutting instrument into the skull to form a cut. For example, multiple burr holes can be drilled in the skull and then the surgeon can cut from one burr hole to another to form the bone flap. The cut can form a gap between the skull and the bone flap that has a maximum width of about <NUM>.

Currently, to secure the bone flap to the skull, the surgeon may use individual bone plates. However, current bone plates have numerous problems. First, current bone plates are small and difficult for a surgeon to handle within the surgical environment. For example, due to the small size of the current bone plates, there is a risk that they could slip from the surgeon's hand and fall into the cranial cavity. In addition, there is a risk of the current bone plates snagging otherwise binding with screws used to fasten them to the skull and bone flap. Should this happen, the current bone plates can spin at a high RPM and cause injury such as cuts, torn surgical gloves, chipping of the patient's skull, etc. <CIT> discloses strip fasteners and cranial plugs for use in reattaching a skull flap removed during brain surgery and methods of using the same.

The compound bone plates disclosed herein reduce or eliminate the problems disclosed above, which were discovered by the inventors of the present disclosure.

The present invention provides a compound bone plate, as defined in claim <NUM>. Further optional features of the invention are defined in the dependent claims. Methods are described herein but the methods are not claimed. To better illustrate the systems and methods disclosed herein, a non-limiting list of summary is provided here:.

According to the present invention, a compound bone plate for attaching a bone flap to a skull comprisesa plurality of plate members, each of the plurality of plate members operable to be attached to the bone flap and the skull;a plurality of burr hole covers; anda strut connecting the plurality of plate members andburr hole covers, wherein the strut comprises a notch which results in a thinning of the strut.

A method for performing a craniotomy is disclosed herein. The method can comprise: drilling at least one burr hole in a skull; cutting the skull at the burr hole to create a bone flap; removing the bone flap from the skull; attaching a first portion of a bone plate assembly to the bone flap; placing the bone flap into an opening formed when the bone flap was removed from the skull; and attaching a second portion of the bone plate assembly to the skull. The bone plate assembly can include a first plate member, a second plate member, a burr hole cover, and a strut connecting the first plate member, the second plate member, and the burr hole cover.

The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments taken in conjunction with the accompanying drawings, wherein:.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure any manner.

For certain neurosurgical procedures, a section of the skull is removed to access the brain. These sections can vary in size depending on how much access surgeons need for treating tumors or trauma to the brain. During surgery, surgeons can use a sterile ink marker to first outline a outline at the area where access is needed. A burr hole can be created for giving a bone saw initial access to cut along the cutline. In some cases, more than one burr hole is created. After the burr holes are created, the bone saw can be used to cut from burr hole to burr hole.

Once the bone flap is separated from the skull, it can then be removed and placed in a sterile area while the surgeon operates on the brain. Upon completion of the procedure, the bone flap is replaced and multiple plates and screws can be used to secure the bone flap to the skull. The plates, sometimes referred to as plate members, can be small and difficult to hold while driving screws to fasten the plates to the skull and bone flap.

The assemblies and methods disclosed herein address the difficulty in holding bone plates by compounding the different plates needed into one plate. For instance, as disclosed herein, multiple bone plates can be connected using one or more struts so as to give surgeons more surface area in which to grip during the driving of the screws or other suitable fasteners. Also, because of this one-piece, or compound, design, the plate itself also can be used as a stencil for surgeons to outline the outlines needed for the selected compound implant.

According to the invention, a compound bone plate includes a plurality of plate members that are joined together by a strut. The compound bone plate also includes a plurality of burr hole covers. The burr hole covers also can act as plate members and can be used to help secure the bone flap to the skull. The strut can be rigid or flexible to allow the surgeon flexibility in determining a shape of the bone flap.

Turning now to the figures, <FIG> shows circular compound bone plate <NUM> in accordance with at least one example of the present disclosure. Compound bone plate <NUM> can include one or more plate members such as a first plate member 102A, a second plate member 102B, a third plate member 102C, and a fourth plate member 102D (collectively plate members <NUM>). Compound bone plate <NUM> also can include one or more burr hole covers <NUM>. As shown in <FIG>, fourth plate member 102D and burr hole cover <NUM> can be combined to form a single structure.

During surgery, compound bone plate <NUM> can be placed against a skull <NUM>. While placed against skull <NUM>, compound bone plate <NUM> can be used as a stencil so that a surgeon can trace an outline showing where cuts can be made in skull <NUM> so that a bone flap <NUM> can be removed. Burr hole cover <NUM> can also be traced around to show where burr holes are to be drilled into skull <NUM>.

<FIG> shows a triangular compound bone plate <NUM> in accordance with at least one example of the present disclosure. Compound bone plate <NUM> includes a first plate member 202A, a second plate member 202B, and a third plate member 202C (collectively bone plate members <NUM>). Compound bone plate <NUM> also includes a first burr hole cover 204A, a second burr hole cover 204B, and a third burr hole cover 204C (collectively burr hole covers <NUM>). As shown in <FIG>, plate members and burr hole covers can be combined into a single structure, such as a first bone plate/burr hole cover 206A, a second bone plate/burr hole cover 206B, and a third bone plate/burr hole cover 206C (collectively, bone plate/burr hole covers <NUM>).

One or more bone plate members <NUM> and bone plate/burr hole covers <NUM> each can include prongs 210A and 210B that include a first portion <NUM> and a second portion <NUM>. As shown in <FIG>, one of the prongs (210B) can project into an interior defined by compound bone plate <NUM> and one of the prongs (210A) can project out of the interior into an exterior portion defined by compound bone plate <NUM>. First portion <NUM> can define a hole <NUM>. Hole <NUM> can be sized to receive a screw <NUM> (see <FIG>) for securing plate members <NUM> and bone plate/burr hole covers <NUM> to a bone flap, such as bone flap <NUM>, and a skull, such as skull <NUM>. Hole <NUM> can include a recess having a rectangular profile as shown in <FIG> or a beveled profile as shown in <FIG> that can allow screw <NUM> or other fasteners to be recessed into the plate members <NUM>. Recessing screw <NUM> can help with comfort for a patient by preventing screw <NUM> from contacting the scalp and/or causing bumps or other protrusions in the scalp.

As shown in <FIG>, one or more bone plate/burr hole covers <NUM> can define one or more openings <NUM>. Openings <NUM> can be utilized by a surgeon to mark skull <NUM>. For example, during surgery, the surgeon can use a marking instrument, such as a pen, marker, or awl, to scribe an outline of one or more of burr hole covers <NUM>. Once the outlines are scribed, the surgeon can remove compound bone plate <NUM> and drill burr holes using the scribed outlines.

Compound bone plate <NUM> also can include a strut <NUM>. As disclosed herein, strut <NUM> can connect plate members <NUM> and bone plate/burr hole covers <NUM> to one another. As shown in <FIG>, strut <NUM> can be divided into segments separated by bone plate/burr hole covers <NUM>. In addition, one of the segments can be divided into a first section <NUM> and a second section <NUM>. By having one of the segments <NUM> divided, compound bone plate <NUM> can be pliable thus allowing compound bone plate <NUM> to be bent into various shapes or expanded as needed during surgery. In addition, the flexible nature of compound bone plate <NUM>, or any compound bone plate disclosed herein, allows the surgeon to manipulate compound bone plate <NUM> to account for cuts that may not be straight or do not exactly follow stencil.

As disclosed herein, one or more plate members <NUM> can be sized so that once the skull is cut, plate members <NUM> can have the same extension on each side of the cut. One or more burr hole covers <NUM> and bone plate/burr hole covers <NUM> can be sized the same way. For example, when compound bone plate <NUM>, or any compound bone plate disclosed herein, is used as a stencil for defining a shape and size of a bone flap, the surgeon may draw and cut on one side (e.g., the interior of compound bone plate <NUM>) of strut <NUM>. As a result, first portion <NUM> of prong 210A can be longer than first portion <NUM> of prong 210B so that holes <NUM> are spaced an equal distance from the cut made in the skull.

<FIG> shows a rectangular compound bone plate <NUM> in accordance with at least one example of the present disclosure. Compound bone plate <NUM> can include a first plate member 402A and a second plate member 402B (collectively bone plate members <NUM>). As shown in <FIG>, bone plate members <NUM> can be located on one side of a strut <NUM>. For example, a bone plate member can be positioned such that it projects into an interior defined by struts <NUM> as shown by bone plate member 402B. A bone plate member can also be positioned such that it projects out of the interior defined by struts <NUM> as shown by bone plate member 402A. In this manner, first plat member 402A and/or second plate member 402B can aid in correctly orienting the bone flap when it is replaced. For example, the surgeon can make a note that first plate member 402A and/or second plate member 402B are located on his/her left when the stencil is created. When replacing the bone flap, the surgeon can again make sure first plate member 402A and second plate member 402B are locate on his/her left, thus ensuring the bone flat is placed correctly into the skull. While <FIG> shows struts <NUM> having a single bone plate member, multiple bone plate members can be located along a single strut.

Compound bone plate <NUM> also can include one or more burr hole covers, such as a first burr hole cover 404A, a second burr hole cover 404B, a third burr hole cover 404C, and a fourth burr hole cover 404D (collectively burr hole covers <NUM>). As shown in <FIG>, plate members and burr hole covers can be combined into a single structure, such as a first bone plate/burr hole cover 406A, a second bone plate/burr hole cover 406B, a third bone plate/burr hole cover 406C, and a fourth bone plate/burr hole cover 406D (collectively, bone plate/burr hole covers <NUM>).

One or more bone plate members <NUM> and bone plate/burr hole covers <NUM> each can include one or more arms, such as a first portion <NUM> and a second portion <NUM>. Second portion <NUM> can define a hole <NUM>. Hole <NUM> can be sized to receive screw <NUM> as described herein and shown in <FIG>. As disclosed herein, holes <NUM> and screws <NUM> can be used to secure one or more plate members <NUM> and bone plate/burr hole covers <NUM> to a bone flap and a skull.

As shown in <FIG>, one or more of bone plate/burr hole covers <NUM> can define one or more openings <NUM>. Openings <NUM> can be utilized by a surgeon to mark skull <NUM>. For example, during surgery, the surgeon can use a marking instrument, such as a pen, marker, or awl, to scribe an outline of one or more of burr hole covers <NUM>. Once the outlines are scribed, the surgeon can remove compound bone plate <NUM> and drill burr holes using the scribed outlines.

Compound bone plate <NUM> also can include a strut <NUM>. As disclosed herein, strut <NUM> can connect one or more of plate members <NUM> and bone plate/burr hole covers <NUM> to one another. As shown in <FIG>, strut <NUM> can be divided into segments and one of the segments can be divided into a first section <NUM> and a second section <NUM>. By having one of struts <NUM> divided, compound bone plate <NUM> can be pliable thus allowing compound bone plate <NUM> to be bent into various shapes or expanded as needed during surgery.

<FIG> shows a circular compound bone plate <NUM> in accordance with at least one example of the present disclosure. Compound bone plate <NUM> can include a first plate member 502A, a second plate member 502B, and a third plate member 502C (collectively bone plate members <NUM>).

Compound bone plate <NUM> also can include a first burr hole cover 504A, a second burr hole cover 504B, and a third burr hole cover 504C (collectively burr hole covers <NUM>). As shown in <FIG>, one or more of plate members and burr hole covers can be combined into a single structure, such as a first bone plate/burr hole cover 506A, a second bone plate/burr hole cover 506B, and a third bone plate/burr hole cover 506C (collectively, bone plate/burr hole covers <NUM>).

One or more bone plate members <NUM> and bone plate/burr hole covers <NUM> each can include prongs that include a first portion <NUM> and a second portion <NUM>. First portion <NUM> can define a hole <NUM>. Hole <NUM> can be sized to receive screw <NUM> as described herein and shown in <FIG>. As disclosed herein, holes <NUM> and screws <NUM> can be used to secure plate members <NUM> and bone plate/burr hole covers <NUM> to a bone flap and a skull. As shown in <FIG>, first portion <NUM> and second portion <NUM> of bone plate members <NUM> can be different sizes. For instance, first portion 510A projecting out of an interior defined by struts <NUM> can be longer than first portion 510B that projects into the interior defined by struts <NUM>.

Compound bone plate <NUM> also can include a strut <NUM>. As disclosed herein, strut <NUM> can connect one or more of plate members <NUM> and bone plate/burr hole covers <NUM> to one another. As shown in <FIG>, one of the segments can divided removed. By having one of segments removed, compound bone plate <NUM> can be pliable thus allowing compound bone plate <NUM> to be bent into various shapes or expanded as needed during surgery.

<FIG> shows a circular compound bone plate <NUM> in accordance with at least one example of the present disclosure. Compound bone plate <NUM> can include a first plate member 602A and a second plate member 602B (collectively bone plate members <NUM>). Compound bone plate <NUM> also can include a bone plate/burr hole cover <NUM>. Compound bone plate <NUM> can include a plate member <NUM> that includes a hole <NUM>.

As disclosed herein, one or more bone plate members <NUM> and bone plate/burr hole covers <NUM> each can include prongs that include a first portion <NUM> and a second portion <NUM>. First portion <NUM> can define a hole <NUM>. Hole <NUM> can be sized to receive screw <NUM> as described herein and shown in <FIG>. As disclosed herein, holes <NUM> and screws <NUM> can be used to secure plate members <NUM> and bone plate/burr hole covers <NUM> to a bone flap and a skull. As shown in <FIG>, second portion <NUM> can connect various bone plate members <NUM>, bone plate member <NUM>, and bone plate/burr hole covers <NUM> to one another. Second portion <NUM> can also include a hole <NUM> located at a center of compound bone plate <NUM>.

Hole <NUM> can allow a surgeon to secure compound bone plate <NUM> to the patient's skull at a single location and rotate compound bone plate <NUM> around the center of compound bone plate <NUM>. Having compound bone plate <NUM> be rotatable provides an advantage in that hole <NUM> can be used in cutting the patient's skull. For example, a router or other skull cutting instrument can be passed through hole <NUM> and compound bone plate <NUM> can be rotated as indicated by arrow <NUM> such that hole <NUM> allows the router or other cutting instrument to cut a perfect or near perfect circular bone flap. Upon cutting the bone flap, other holes defined by bone plate member <NUM>, <NUM>, and bone plate/burr hole covers <NUM> can be used to secure compound bone plate <NUM> to both the bone flap and the patient's skull upon completion of the surgical procedure.

Compound bone plate <NUM> also can include a strut <NUM>. As disclosed herein, strut <NUM> can connect one or more of plate members <NUM>, <NUM> and bone plate/burr hole covers <NUM> to one another. Strut <NUM> can allow compound bone plate <NUM> to be used as a stencil as disclosed herein.

<FIG> shows a detail of compound bone plate <NUM>. As shown in <FIG>, strut <NUM> includes a first notch <NUM> and optionally a second notch <NUM>. While <FIG> shows first notch <NUM> and second notch <NUM> located proximate plate member <NUM>, notches, such as first notch <NUM> and second notch <NUM> may located proximate or adjacent to each of the plate members, bone plate/burr hole covers, or other components of a compound bone plate disclosed herein.

Consistent with the various embodiments disclosed herein, notches can have a "v" shape or other shape that results in a thinning of a strut, such as strut <NUM> as shown in <FIG>. The notches can allow the surgeon to cut the strut and remove potions of the strut that are initially used to connect the various components of a compound bone plate to one another.

The bone plate assemblies disclosed herein can be constructed of metals, polymers, ceramics, or combinations thereof. In addition, the bone plate assemblies can be constructed using various manufacturing methods, including, but not limited to, stamping, pressing, overmolding, etc. For example, the struts and plate members can be constructed of a metal, such as stainless steel or titanium. The metal billet can be stamped to create the basic shape of the bone plate assemblies including any holes needed therein. Stated another way, the bone plate assemblies can be monolithic and stamped, pressed, etc. from a single piece of metal. Once the basic shape is created, the metal structure can be overmolded with a polymer so as to cover any sharp edges of the metal structure. In another example, the bone plate assemblies can be constructed entirely of a polymer and injection molded into a desired shape, such as a triangle shown in <FIG>, a rectangular pattern as shown in <FIG>, or a circle as shown in <FIG>. While <FIG>, <FIG>, <FIG>, and <FIG> show bone plate assemblies that are symmetric (e.g., rectangles, circles, elliptical, equilateral triangles, oval, pentagonal, square, etc.), bone plate assemblies can be asymmetric and the bone plate members and burr hole covers can be arranged in asymmetrical patterns. In still another example, the various plate members, burr hole covers, struts, etc. can be made as individual pieces and assembled, either at a factory by a manufacturer or in an operating room by a surgeon.

As disclosed herein, the various compound bone plates disclosed herein can be manufactured from materials such as metals and polymers. Non-limiting examples of suitable materials can include, titanium and polyether ether ketone (PEEK). The various compound bone plates disclosed herein can have a thickness of about <NUM> to <NUM> thousandths of an inch (<NUM>,<NUM> to <NUM>,<NUM>). The thin nature of the various compound bone plates can allow for the compound bone plates to be bent so as to conform to a curvature or other irregularities of a patient's skull.

One or more of the various compound bone plates disclosed herein can also be included in a sterile kit or system that can include screws for attaching the compound bone plates to a patient's skull. For example, multiple compound bone plates can be included as a system that includes screws already partially attached to the compound bone plates. Each of the compound bone plates can be different sizes and shapes as disclosed herein. Thus, during surgery, the surgeon can select a compound bone plate that has the appropriate size and shape as needed for the patient's condition. The screws can be from about <NUM> long to about <NUM> long.

In addition, the bone plates assemblies disclosed herein can be components of a system. The system can include a plurality of bone plate assemblies. Each of the plurality of bone plate assemblies can be a different size and/or shape from other bone plate assemblies within the system. For example, the systems can include various bone plate assemblies that are different sizes, yet have the same basic shape, number of burr hole covers, plate members, etc. with the same basic arrangement. In another example, the systems can include various bone plate assemblies that are different sizes, and have different basic shapes (circular, rectangular, etc.) with different numbers of burr hole covers, plate members, etc. with different arrangements. As such, during surgery, a surgeon can select the appropriate compound bone plate for the patient's skull size as well as the geometry of the hole needed to access the brain.

<FIG> shows an example method <NUM> for performing a craniotomy (not claimed) in accordance with at least one example of the present disclosure. Method <NUM> can begin at stage <NUM> where a compound bone plate, such as compound bone plate <NUM>, <NUM>, <NUM>, or <NUM>, may be used as a stencil. For example, as shown in <FIG>, compound bone plate <NUM> can be used to trace an outline <NUM> of a bone flap <NUM> and burr holes <NUM> onto a skull <NUM>.

After outline <NUM> has been created, method <NUM> can proceed to stage <NUM> where burr holes <NUM> can be drilled into skull <NUM>. From stage <NUM> method <NUM> can proceed to stage <NUM> where bone flap <NUM> can be cut. For example, as disclosed herein, once burr holes <NUM> are drilled a saw can be used to cut along outline <NUM> between burr holes <NUM>.

Once skull <NUM> has been cut, bone flap <NUM> can be removed from skull <NUM> in stage <NUM>. Removal of bone flap <NUM> can allow the surgeon to access the brain. Once the brain is accessible, the craniotomy can be performed. After the craniotomy is performed, compound bone plate <NUM> can be attached to bone flap <NUM> in stage <NUM> using screws <NUM>. Once compound bone plate <NUM> is attached to bone flap <NUM>, bone flap <NUM> can be placed in the opening in skull <NUM> created when bone flap <NUM> was removed from skull <NUM>. By attaching compound bone plate <NUM> to bone flap <NUM> prior to placing bone flap <NUM> in the opening, compound bone plate <NUM> can prevent bone flap <NUM> from falling into the cranial cavity and/or otherwise contacting the brain.

Still consistent with embodiments disclosed herein, compound bone plate <NUM> can be attached to bone flap <NUM> before bone flap <NUM> is removed from skull <NUM>. By attaching compound bone plate <NUM> to bone flap <NUM> before cutting skull <NUM> with a cranial saw, compound bone plate <NUM> can prevent bone flap <NUM> from falling into the cranial cavity and/or otherwise contacting the brain during cutting of skull <NUM>.

From stage <NUM> method <NUM> can proceed to stage <NUM> where compound bone plate <NUM> can be attached to skull <NUM>. For example, screws <NUM> can be used to attach second portion <NUM> of compound bone plate <NUM> to skull <NUM>. Once bone flap <NUM> is attached to skull <NUM>, burr holes <NUM> can be filled in stage <NUM>. For example, a fill material can be injected into burr holes <NUM> via openings <NUM>. Examples of the fill material can include, but are not limited to, CopiOs® bone void filler manufactured by ZIMMER BIOMET® of Warsaw, Indiana, naOss® bone void filler manufactured by RTI SURGICAL® of Marquette, Michigan.

Claim 1:
A compound bone plate (<NUM>, <NUM>, <NUM>,..) for attaching a bone flap to a skull, the compound bone plate comprising:
a plurality of plate members (<NUM>, <NUM>, <NUM>,..), each of the plurality of plate members operable to be attached to the bone flap and the skull;
a plurality of burr hole covers (<NUM>,<NUM>, <NUM>,..); and
a strut (<NUM>, <NUM>,..) connecting the plurality of plate members (<NUM>, <NUM>, <NUM>,..) and burr hole covers (<NUM>, <NUM>, <NUM>,..), characterised in that the strut comprises a notch (<NUM>, <NUM>) which results in a thinning of the strut.