Patent Description:
Osteosynthesis is a surgical procedure for the fixation of bone, that may be used to treat bone fractures, or in bone reconstruction surgery. Bone fragments (either fractured bone fragments in the case of a bone fracture or segments of grafted bone in the case of a reconstruction) are joined with screws, plates, nails or wires.

For example, reconstruction of the lower jaw (mandible) is commonly performed following removal of a malignant tumour or disease. Typically, this involves placement of a bone graft from the leg into the jaw, which is then secured in place with a single titanium osteosynthesis reconstruction plate allowing healing via the growth of new bone material to take place over the course of several weeks or months.

The use of a single plate provides a support structure that is stiff and supports loads to which the healing bone structure might be subjected. However, when using a single plate, if there is a problem with one part of the plate - for example, if the patient develops an infection at the site of one of the screws fixing the plate to the bone fragments - then the entire plate may need to be removed and replaced, and potentially all of the grafted bone may also need to be replaced.

An alternative approach uses multiple so-called "mini-plates" which are arranged to share the load. Such mini-plates are inherently lighter and can be more flexible in the sense that the same design of mini-plate may be used in multiple, different, applications (and possibly with multiple patients), rather than being custom made for one specific patient's needs. Mini-plates may be either 'off-the-shelf' miniplates or 'custom' mini-plates. 'Off-the-shelf' miniplates are not produced for any specific patient and are typically bent by hand into a configuration that meets the requirement of whatever patient they are to be used on. In contrast, custom mini-plates are produced for specific patients (for example using 3D printing) in a pre-determined configuration that meets the requirements of the specific patient they are to be used on. The miniplates are easier to remove in the event of failure, infection etc. because only the affected miniplate at a single osteotomy site needs to be removed (as opposed to the whole plate). In this respect they are potentially safer since removal of a single miniplate can be achieved with a smaller incision rather than requiring extensive surgical access.

However, the use of miniplates comes with some potential drawbacks. For example, positioning multiple miniplates placed in series to support a reconstructed portion of bone material is technically more difficult for a surgeon to achieve. Accordingly, there is an increased probability that errors in the placement of the miniplates will occur. In particular, relatively minor angulation errors in screw placement at each miniplate can potentially lead to a more significant vector error overall along the length of the osteotomised region (e.g. a fibular flap), thus compromising morphological accuracy. Such errors in placement can accumulate (in an additive manner), making the overall result less accurate with respect to surgical procedures that use a single, bespoke, plate.

These problems are solved or mitigated by the apparatus of claim <NUM>. The dependent claims are related to further embodiments of the invention.

According to the invention, there is provided an apparatus according to claim <NUM>.

In some embodiments, the plurality of connection structures each comprises one or more connection portions for connecting the respective connection structures to an anatomical structure.

In some embodiments, the one or more connection portions each comprises a through hole for receiving a fixing device arranged to fix the respective connection structure to an anatomical structure.

In some embodiments, the through holes are for receiving a screw arranged to fix the respective connection structure to an anatomical structure.

In some embodiments, the apparatus is for providing structural support to a plurality of bone fragments.

In some embodiments, the plurality of connection structures is formed with the frame structure by an additive manufacturing process.

In some embodiments, the apparatus comprises separation portions located between the frame structure and the plurality of connection structures, the separation portions each being arranged to provide a break point between the frame structure and the plurality of connection structures.

In some embodiments, the apparatus comprises a metal material. For example, the metal material may be titanium or cobalt chrome.

<FIG> is a schematic diagram showing a pictorial view illustrating a conventional osteosynthesis reconstruction plate <NUM> used for mandibular reconstruction. The reconstruction plate <NUM> comprises a preformed, single-piece, metallic frame that provides a rigid support structure. The reconstruction plate <NUM> comprises connection portions <NUM> for connecting the reconstruction plate <NUM> to portions of bone from the natural anatomy of a patient (referred to hereinafter as first bone portions <NUM>) and portions of bone which are to be used as a bone graft, which may have been harvested from another part of the patient's anatomy (referred to hereinafter as second bone portions <NUM>). The reconstruction plate thereby acts to anchor the second bone portions <NUM> to the first bone portions and to provide support to the second bone portions <NUM> to maintain their position and alignments with respect to the first bone portions <NUM>.

Although, the reconstruction plate <NUM> described above with reference to <FIG> is described with reference to a mandibular reconstruction procedure using grafted bone, in some applications, the same or a similar reconstruction plate <NUM> can be used in the repair of a fracture. In such applications of the reconstruction plate <NUM>, the second bone portions <NUM> may also be bone portions from the patient's natural anatomy, rather than grafted bone fragments.

The reconstruction plate <NUM> is designed to be attached via the connection portions <NUM> to the first and second bone portions <NUM>, <NUM>. For example, the connection portions <NUM> may comprise through holes located in the apparatus <NUM> through which screws or other fasteners may be inserted to connect the reconstruction plate <NUM> to the first and second bone portions <NUM>, <NUM>, thereby providing structural support for the first and second bone portions <NUM>, <NUM> while the respective bone portions <NUM>, <NUM> heal.

<FIG> is a schematic diagram showing a pictorial view illustrating an apparatus <NUM> according to the present invention. The apparatus <NUM> may be used in place of the prior art reconstruction plate <NUM> described above with reference to <FIG>.

The apparatus <NUM> comprises a series of connection structures, referred to herein as miniplates <NUM>, attached to each other by a removable frame structure referred to herein as a jig bar <NUM>.

The connection structures each comprise one or more connection portions <NUM>, which are the same or similar to the connection portions <NUM> described above with reference to <FIG>. In particular, the connection portions <NUM> may comprise through holes located in the apparatus <NUM> through which screws or other fasteners may be inserted to connect the miniplates <NUM> to the first and second bone portions <NUM>, <NUM>, thereby providing structural support for the first and second bone portions <NUM>, <NUM> while the respective bone portions <NUM>, <NUM> heal.

The jig bar <NUM> is formed with the miniplates <NUM> to maintain the position and orientation of each of the miniplates <NUM> while the miniplates are being fixed to the appropriate anatomical structures during a surgical procedure. In particular, at the time of fixation of the apparatus <NUM> to a patient, the multiple miniplates <NUM> are fixed to the jig bar <NUM> so that the surgeon can easily handle the apparatus <NUM> (by e.g. gripping the jig bar <NUM>), can manipulate the apparatus <NUM> (and therefore all of the respective miniplates <NUM>, at once) into the correct position and orientation, and then affix the miniplates <NUM> to the appropriate tissue or bone structures of the patient. In other words, the apparatus <NUM> described with reference to <FIG> provides at least the same, and possibly improved, positional accuracy as the prior art reconstruction plate <NUM> described with reference to <FIG>. Furthermore, physical separation of the jig bar <NUM> from the miniplates <NUM> of the apparatus <NUM> of <FIG> provides a means for the surgeon to handle and manipulate the apparatus <NUM> more easily than the reconstruction plate <NUM> described with reference to <FIG> can be handled, while the apparatus <NUM> is being fixed in place.

As described in more detail below, with reference to <FIG>, once the miniplates <NUM> are fixed in place, the surgeon can remove the jig bar <NUM>. For example, using a bur tool, the surgeon may separate the jig bar <NUM> from the miniplates <NUM>.

In some embodiments, as shown in <FIG>, the apparatus <NUM> comprises separation portions <NUM> between the jig bar <NUM> and each of the miniplates <NUM>. The separation portions <NUM> may, in some examples, comprise a region which is formed of material that is thinner than the surrounding material. For example, the separation portions <NUM> may comprise a waist between the jig bar <NUM> and the miniplates <NUM>.

As depicted in <FIG>, in this example, the jig bar <NUM> comprises a support member <NUM> and a plurality of spurs <NUM> each of which extends away from, for example, transversely or laterally, the support member <NUM> and connects to a respective one of the miniplates <NUM>. In this example, the support member <NUM> is a bar. The support member <NUM> comprises a first section 205a and a second section 205b which are joined at a bend <NUM> and define an angle which, in this example, is obtuse. A respective spur <NUM> extends from each end of the support member <NUM> and from the bend. In this example, the first section 205a is longer than the second section 205b although it should be appreciated that the configuration of the apparatus <NUM>, including the lengths of the first section 205a and the second section 205b and the angle between them, will depend upon the requirements of the surgical procedure that is to be performed.

In some examples the separation portions <NUM> may comprise a thinned portion of the respective spurs <NUM> located at or near the points where the spurs <NUM> meet the miniplates <NUM>. In some examples, the separation portion <NUM> may be sufficiently thinned as to allow the surgeon to snap the jig bar <NUM> away from the miniplates <NUM>.

The apparatus <NUM> described above with reference to <FIG> may be formed of any appropriate material. However, in preferred examples, the apparatus <NUM> is formed of a metal material such as titanium or cobalt chrome. In other examples, the apparatus <NUM>, or portions of the apparatus <NUM> such as the miniplates <NUM>, may be formed of a resorbable material. For example, the apparatus <NUM>, or portions of the apparatus <NUM> such as miniplates <NUM>, may be formed from poly L-lactide (PLLA), polyglycolide (PGA), poly D-lactide (PDLA) or some combination thereof.

In the example of a fibular mandibular reconstruction, as described above, the surgeon can manipulate the apparatus <NUM> such that the miniplates <NUM> configured (i.e. positioned and orientated) to meet with the first bone portions <NUM>), fix those miniplates <NUM> to the first bone portions <NUM>, and then fix the second bone portions <NUM> to the correspondingly positioned and orientated miniplates <NUM>. Accordingly, the second bone portions <NUM> can be fixed in the correct position and orientation as a single unit thus minimising the possibility that the miniplates <NUM> will be positioned incorrectly. Once the miniplates <NUM> are fixed to the first and second bone portions <NUM>, <NUM>, in the required spatial position and orientation, the surgeon can remove the jig bar <NUM>.

Attaching the miniplates <NUM> to the jig bar <NUM> as a single unit may provide that fixation will be technically easier and therefore quicker to perform, reducing surgical time.

Advantageously, the jig bar <NUM> connects the miniplates <NUM> in parallel but stands away from the bone portions <NUM>, <NUM> when the surgical procedure to fix the miniplates <NUM> into position is ongoing. This reduces the likelihood of there being damage or interruption of the blood vessels and/or muscle or soft tissue around the bone portions <NUM>, <NUM> and between the individual miniplates <NUM>.

Furthermore, removing the jig bar <NUM> as a single unit from the miniplates <NUM> after the miniplates <NUM> have been fixed into position simplifies the surgical procedure.

It will be understood that while the examples described herein relate to reconstruction plates for repair or reconstruction of mandibles, the principles disclosed are applicable to apparatus for supporting other anatomical structures. For example, the apparatus <NUM> may be designed to provide structural support to other axial or appendicular skeletal structures such as leg, arm, hand or foot bones, cranial bones, facial bones, vertebral bones and/or pelvic bones, or for soft tissues such as tendons, ligaments, blood vessels, muscle tissue, neural tissue (in the brain or elsewhere in the nervous system), and/or cardiac tissue (such as heart valves or myocardium).

<FIG> is a flow diagram illustrating a method <NUM> of manufacturing an apparatus, such as the apparatus <NUM> described above with reference to <FIG>.

At block <NUM>, a model of an apparatus is received. The model is based image data representing an image of an anatomical structure. For example, in relation the mandibular reconstruction example described above with reference to <FIG>, the image data may represent an image of the skull, or a portion of the skull including the mandible, of a patient to which an apparatus <NUM> is to be applied (for example, by surgical implantation).

In some examples, the model may be generated based on image data received from a third party. For example, the image data may be retrieved from a picture archiving and communication system (PACS). For example, the image may be routed to a data processing apparatus using Digital Imaging and Communications in Medicine (DICOM) routing. In some embodiments, the data processing apparatus may be part of an image acquisition system, such as, for example, an X-ray fluoroscopy device, a computed tomography device, a magnetic resonance imaging device a molecular imaging device, a SPECT device, a PET device or combinations thereof. Alternatively, the data processing apparatus may be separate from the imaging device used to acquire an image and may be retrieved by the data processing apparatus or sent to the data processing apparatus via a communications interface.

The data processing apparatus may be a general-purpose computing device executing software arranged to generate the model based on the image data representing the image of the anatomical structure.

At block <NUM>, an apparatus, such as the apparatus <NUM> described above with reference to <FIG>, is manufactured based on the received model. For example, the apparatus may be manufactured using an additive manufacturing process.

Additive manufacturing is a process by which a structural component can be formed by selectively adding layers of material, rather than removing, for example by machining, material to form the component. For example, in some additive manufacturing processes, a layer of powdered material is deposited, and particles of the powdered material are selectively fused (for example by melting the powdered particles with a directable energy source). Following fusion of a selected portion of the layer, a further layer of powdered material is deposited and selectively fused. By selectively fusing the powdered material in multiple layers, a three-dimensional object or component can be manufactured.

Additive manufacturing processes can be used to produce bespoke components because the dimensions of components manufactured by an additive manufacturing process can be easily specified using, for example, computer aided design (CAD) tools. Furthermore, additive manufacturing processes can enable components with complex geometries to be produced, which would otherwise be difficult to produce using non-additive manufacturing processes.

The additive manufacturing process may include one or more of: selective laser melting; 3D inkjet printing; laser sintering; electron beam melting.

Alternatively, the apparatus <NUM> could be manufactured by a subtractive manufacturing method, such as milling, or by other manufacturing (not classified as additive or subtractive), such as casting.

<FIG> is a flow diagram illustrating a method <NUM> of installing an apparatus, such as the apparatus <NUM> described above with reference to <FIG>. That is an apparatus comprising a plurality of connection structures and a frame structure connecting each of the plurality of connection structures, in which the frame structure is arranged to maintain the predetermined orientations of the plurality of connection structures and the predetermined separations between the plurality of connection structures.

At block <NUM>, one or more connection structures (e.g. miniplates <NUM>) is connected to one or more anatomical structures. For example, as described above, the connection structures may comprise through holes for receiving screws, plates, nails wires, pins, sutures, or other fixing means to physically fix the connecting structures to a portion of the anatomy of a patient.

At block <NUM>, once each of the required connection structures (e.g. miniplates <NUM>) is connected and the apparatus (e.g. apparatus <NUM>) is fixed in place, the frame structure (e.g. the jig bar <NUM>) is separated from the one or more connection structures (e.g. miniplates <NUM>). For example, during a surgical procedure, a surgeon may use a surgical bur tool, cutting pliers, or any other appropriate tool, to cut through a join between the frame structure and the connection structures. That is, in relation to the apparatus <NUM> described with reference to <FIG>, the surgeon can remove the jig bar <NUM> from the miniplates <NUM>, to then close the surgical wound without any protruding medical apparatus.

Accordingly, the apparatus <NUM> described herein, the methods of manufacturing such an apparatus, and the methods of installing such an apparatus, may provide significant improvements to the ease and/or efficiency with reconstructive surgery can be performed. In particular, the apparatus <NUM> described above with reference to <FIG> may provide the accurate placement of the prior art reconstruction plate described with reference to <FIG>, while not suffering the potential drawbacks that the reconstruction plate <NUM> of <FIG> has in the event of a problem following installation of the plate <NUM>. Meanwhile, in the event of a post-surgical problem, the apparatus <NUM> described herein has the advantage of conventional miniplates that only the miniplate at the affected osteotomy site needs to be removed (and that therefore the post-surgical incision can be much smaller, reducing the impact on the patient).

Claim 1:
An apparatus (<NUM>) for providing structural support to an anatomical structure (<NUM>), the apparatus (<NUM>) comprising:
a plurality of connection structures (<NUM>) being arranged that, in use, they are each connectable to respective points on the anatomical structure (<NUM>), and wherein, in use, each connection structure (<NUM>) is arranged to be orientated in a predetermined orientation relative to each of the other connection structures (<NUM>) and to be separated from each of the other connection structures (<NUM>) by a predetermined separation; and
a frame structure (<NUM>) formed with and connecting each of the plurality of connection structures (<NUM>) together in order to maintain the predetermined orientations of the plurality of connection structures (<NUM>) and the predetermined separations between the plurality of connection structures (<NUM>) while the plurality of connection structures (<NUM>) are being connected to the anatomical structure (<NUM>), wherein the frame structure (<NUM>) comprises a bar (<NUM>) and a plurality of spurs (<NUM>) which extend away from the bar (<NUM>), each spur (<NUM>) connecting laterally to a respective different one of the connection structures (<NUM>) and wherein the frame structure (<NUM>) is removable from the plurality of connection structures (<NUM>) after the plurality of connection structures (<NUM>) have been connected to the anatomical structure (<NUM>).