BONE RECONSTRUCTION IMPLANT

Abstract

Bone reconstruction implants and systems comprising the implants are provided. The implants and systems find use in monitoring and/or modulating the health of a patient. The bone reconstruction implants may be contoured to conform to the surface contours of a bony defect and comprise one or more functional elements. The functional elements may be positioned within the bone reconstruction implant so as to maximize alignment or interaction with functional elements in implanted medical devices, internal anatomical features or external devices.

Claims

1-58. (canceled)

59. The system for monitoring the health of a patient and/or modulating the health of a patient, said system comprising: (a) at least one bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient, said implant being implanted to correct a bony defect in said patient; and (b) at least one other device internal and/or external to said patient's anatomy, said at least one other device comprising one or more functional elements, wherein at least one functional element in the bone reconstruction implant and at least one functional element in the at least one other device are in communication.

60. A system for monitoring the health of a patient and/or modulating the health of a patient, said system comprising: (a) at least one bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient, said implant being implanted to correct a bony defect in said patient; and (b) at least one external device positioned on said patient's external anatomy, said external device comprising one or more functional elements, wherein the at least one functional element in the bone reconstruction implant and at least one functional element in the external device are in communication.

61. The system according to claim 59, wherein the at least one functional element in the bone reconstruction implant and the at least one functional element in the internal and/or external device are substantially aligned.

62. The system according to claim 59, wherein the at least one functional element in the bone reconstruction implant is substantially aligned with an internal anatomical feature of said patient.

63. The system according to claim 59, wherein the at least one external device comprises one or more surfaces, said one or more surfaces having at least one region contoured to substantially match at least one contour of an external anatomical surface of the patient.

64. The system according to claim 59, wherein at least one of the one or more functional elements in the internal and/or external device and at least one of the one or more functional element in the implanted bone reconstruction implant overlap in at least one respective surface by at least 10%.

65. The system according to claim 59, wherein at least one of the one or more functional elements in the internal and/or external device and at least one of the one or more functional elements in the implanted bone reconstruction implant are positioned relative to one another so that an angle between a longitudinal axis through the functional element in the internal and/or external device and a longitudinal axis through the functional element in the implanted bone reconstruction implant is less than 90.

66. The system according to claim 59, wherein a center of at least one of the one or more functional elements in the internal and/or external device and a center of at least one of the one or more functional elements in the implanted bone reconstruction implant are offset from each other by no more than 10%, relative to the largest dimension of the functional element in the bone reconstruction implant.

67. The system according to claim 59, wherein the functional element is selected from temperature sensors, biochemical sensors, mechanical sensors, electrical sensors, ultrasonic sensors, optical sensors, fluid/pressure control elements, stimulating electrodes, stimulating electromagnets, light sources, ultrasonic emitters, power generation elements, energy delivery or receiving elements, and combinations thereof.

68. The system according to claim 59, wherein the at least one functional elements are configured for at least one of sensing, communicating, actuating, delivering or receiving information, delivering or receiving energy, generating energy, or modifying the activity, functioning or physical properties of a biological tissue.

69. The system according to claim 59, wherein the at least one functional elements are configured for monitoring and/or measuring patient specific parameters and/or non-patient specific parameters.

70. The system according to claim 59, wherein the patient specific parameters include, temperature, pressure, electrophysiological changes, the concentration and/or nature of one or more chemical species, and combinations thereof.

71. The system according to claim 59, wherein the non-patient specific parameters include temperature, pressure, light intensity, electromagnetic radiation, sound, the concentration and/or nature of one or more chemical species, and combinations thereof.

72. The system according to claim 59, wherein the one or more functional elements sense and quantify environmental parameters, including light, sound, electromagnetic radiation, thermal radiation or gravitational forces, and combinations thereof.

73. The system according to claim 59, wherein the one or more functional elements comprise GPS and satellite communication systems.

74. The system according to claim 59, wherein the one or more functional elements enable remote monitoring and feedback.

75. The system according to claim 59, wherein the one or more functional elements are in communication with one or more functional elements in one or more devices remote from the patient.

76. The system according to claim 75, wherein the one or more devices remote from the patient include at least one of a mobile device or a computer server.

77. The system according to claim 59, wherein at least one functional element in the implanted device is in communication with one or more further functional elements in the implanted device.

78. The system according to claim 59, wherein at least one of the one or more functional elements in the implanted device is in communication with one or more functional elements in one or more further implanted devices in the patient.

79. The system according to claim 59, wherein at least one of the one or more functional elements in the implanted device is removable from the implanted device.

80. The system according to claim 59, wherein at least one functional element in the implanted device is powered by one or more interfaces based on one or more of electromagnetic, optical, ultrasonic and electrical means, or at least one functional element comprises one or more power generation devices comprising energy harvesting technology, biological fuel-cell technology or other energy generation technologies amenable to implantation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0218] FIG. 1 illustrates an implant according to an embodiment of the present disclosure.

[0219] FIG. 2 illustrates another implant according to an embodiment of the present disclosure.

[0220] FIG. 3 illustrates another implant according to an embodiment of the present disclosure.

[0221] FIG. 4 illustrates another implant according to an embodiment of the present disclosure.

[0222] FIG. 5 illustrates another implant according to an embodiment of the present disclosure.

[0223] FIG. 6 illustrates another implant according to an embodiment of the present disclosure.

[0224] FIG. 7 illustrates another implant according to an embodiment of the present disclosure.

[0225] FIG. 8 illustrates another implant according to an embodiment of the present disclosure.

[0226] FIG. 9 illustrates another implant according to an embodiment of the present disclosure.

[0227] FIG. 10 illustrates a system according to an embodiment of the present disclosure.

[0228] FIG. 11 illustrates a system according to an embodiment of the present disclosure.

[0229] FIG. 12 illustrates a system according to an embodiment of the present disclosure.

[0230] FIG. 13 illustrates a system according to an embodiment of the present disclosure.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0231] Throughout this specification, use of the terms comprises or comprising or grammatical variations thereon shall be taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof not specifically mentioned.

[0232] Before the present devices and/or methods and/or systems are disclosed and described, it is to be understood that unless otherwise indicated this disclosure is not limited to specific devices, components, systems, designs, methods, or the like, as such may vary, unless otherwise specified. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0233] It must also be noted that, as used in the specification and the appended claims, the singular forms a, an and the include plural referents unless otherwise specified. Thus, for example, reference to an implant may include more than one implants, and the like.

[0234] Disclosed herein are advantageous implants, methods and systems for delivering health care. The implants, methods and systems may be based on patient specific information or patient specific anatomy. Accordingly, a patient specific implant contoured to a patient's bony anatomy may be provided.

[0235] In some embodiments, the bone reconstruction implant of the present disclosure contains one or more permanently-housed functional elements, the elements being encapsulated within the substance of the implant and wherein the elements cannot be removed without disrupting the physical integrity of the implant. In other embodiments, the one or more elements are housed within one or more voids incorporated within the implant.

[0236] The one or more voids may be incorporated in the implant in a variety of ways.

[0237] In one embodiment the one or more voids may span the entire thickness of one or more dimensions of the implant. FIG. 1 illustrates a cross section of such a bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). The void spans the entire thickness of the vertical dimension of the implant.

[0238] In other embodiments the one or more voids may span a partial thickness of the implant. FIG. 2 illustrates a cross section of bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). The void spans only a partial thickness of the vertical dimension of the implant.

[0239] In one embodiment, wherein one or more voids constitute part of the outer edge of the implant, the one or more functional elements intended to occupy the one or more voids may be designed and fabricated such that their dimensions and shape are consistent with the anatomy of the bony defect into which the implant is placed. This embodiment is illustrated in FIG. 3 where implant (1) contains functional element (4). In this embodiment, both the bone reconstruction implant and the one or more functional elements are contoured so that their shapes are patient specific.

[0240] FIG. 4 illustrates a cross section of a bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). In this embodiment the functional element is positioned in the void such that a single surface is exposed.

[0241] FIG. 5 illustrates a cross section of a bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). In this embodiment the functional element is positioned in the void such that two surfaces are exposed.

[0242] The one or more voids may constitute a large area or volume of the bone reconstruction implant. The one or more voids may constitute a small area or volume of the implant. The one or more voids may constitute part of the outer edge of the implant. The one or more voids may be contained entirely within the perimeter of the implant. This embodiment is illustrated in FIG. 6, where implant (1) contains void (3). The one or more voids may be of any shape. The one or more voids may be substantially circular in shape. The one or more voids may be substantially square in shape. The skilled artisan will appreciate that the one or more voids may be designed and fabricated to conform to any shape, and in a variety of, or combinations of shapes.

[0243] The implants may be curved in shape. The implants may be non-curved in shape.

[0244] One or more of the one or more voids may be designed such that a functional element may be inserted at an angle of about 90 degrees to the implant at the point of insertion (as illustrated in FIG. 1). Alternatively, the angle of insertion may be substantially parallel to the implant at the point of insertion (as illustrated in FIG. 5). In further embodiments, one or more functional elements may be inserted into one or more voids at a variety of insertion angles.

[0245] In one embodiment of the presently disclosed implant, wherein one or more of the one or more functional elements are housed within a void, the one or more functional elements may be intended to be permanently housed, for example by means of permanent fixation. Examples of such permanent fixation include by use of a biocompatible glue, or subsequent to bony ingrowth into the outer margins of the one or more functional elements. These examples are not intended to be limiting, and the skilled artisan will appreciate that other methods of permanent fixation, not herein described, may be utilised.

[0246] In one embodiment of the implant, wherein one or more of the one or more functional elements are contained within a void, the one or more functional elements may be removable. The one or more functional elements may be secured in place by using standard surgical fixation hardware including but not limited to screws, plates, rivets and the like. In another embodiment, the one or more functional elements may be secured by a screw mechanism. That is, a void may contain a receiving thread, into which the outer threaded surface of a functional element may be screwed to achieve fixation of the functional element. In another embodiment, a functional element may be secured by a keyed sliding mechanism, for example there may be receiving channels in a void, into which physical extensions of the outer surface of a functional element are designed to fit. The skilled artisan will appreciate that numerous securing or interlocking mechanisms may be utilised to ensure firm attachment of one or more functional elements into a void, and the examples given are not intended to be limiting.

[0247] It may be advantageous for the one or more functional elements to have a predictable alignment to an adjacent body structure, for example a tissue, and therefore the securing mechanism may be keyed. That is, the securing mechanism ensures a functional element being inserted into a void is required to be inserted in a manner that optimises the proximity of functional elements to a bodily structure or tissue. An example may be given in the case of a cranial implant containing a void, into which a housing containing electrodes on its outer surface is inserted at an angle approximately parallel to a region of the implant. To ensure the electrodes face the underlying brain correctly, the outer surface of the housing and the inner surface of the void may be keyed to guarantee correct orientation of the housing and therefore electrodes with respect to the brain surface.

[0248] In one embodiment, wherein the bone-reconstruction implant contains both permanent and removable functional elements, the permanent and removable functional elements may operate independently. In another embodiment, the permanent and removable functional elements perform a combined function.

[0249] In one embodiment, the permanent and removable functional elements may be physically connected, thereby facilitating the transfer of energy, information, or other functionally-relevant properties from one functional element to another.

[0250] In an embodiment of the bone-reconstruction implant containing one or more voids within which one or more functional elements may be housed, it will be appreciated that, where appropriate, it may be advantageous for the voids to be of a shape and dimensions that are consistent from one implant to the next. Therefore, a functional element of standard shape and size may be designed and manufactured to fit into the one or more voids. Thus, by combining the methods of mass manufacture and patient-specific implant design, an optimal combination of optimal anatomic fit and cost of manufacture can be achieved. Alternatively, as clinical needs dictate, the shape of the one or more voids, and therefore the shape of the one or more functional elements, may be designed and manufactured on an individual basis. Thus, the bone-replacing implant may contain one or more patient specific voids, into which one or more patient-specific functional elements may be inserted. Alternatively, the implant may contain one or more voids of a consistent size and shape (i.e. standardised voids), into which one or more functional elements of consistent size and shape (i.e. off the shelf functional elements) may be inserted. Alternatively, the implant may contain a combination of patient specific voids and functional elements, and standardised voids and off the shelf functional elements.

[0251] It will be appreciated that a combination of anatomical data obtained using one or more imaging devices and additive manufacturing provides an advantageous method by which patient specific bone-reconstruction implants may be fabricated. Furthermore, it will be appreciated that a combination of anatomical data obtained using one or more imaging devices and additive manufacturing provides an advantageous method by which a patient-specific, bone-reconstruction implant may be fabricated, within which one or more or a combination of patient-specific voids or standardised voids may be incorporated.

[0252] The one or more functional elements may comprise one or more functional or structural components. The structural components may comprise housings or casings, fixation devices (for example, screws, rivets and the like) or the aforementioned components of a system intended to secure a functional element to a void.

[0253] The one or more structural components may be manufactured from a variety of materials, including but not limited to soft or hard plastics/polymers, or materials with a continuum of physical properties that would render these materials as being soft, hard, or anywhere in between, metals (such as titanium and other metals or metal alloys that are amenable to implantation), ceramics, or composites of these materials. Those skilled in the art will appreciate that other biocompatible materials may be used, and the examples given should not be taken to be limiting.

[0254] The structural components may be manufactured using additive manufacturing techniques, or by conventional techniques such as subtractive manufacturing (for example, CNC machining or multi-axis routing), injection moulding and so on.

[0255] The functional elements may be contained entirely within the structural components; that is to say that the structural components may completely encapsulate the functional elements. Alternatively, the functional elements may form an integral part of the structural components. For example, a functional element may comprise structural components being a polymer casing within which functional components, being electronic components, are contained, whilst the exterior of the casing contains integrated electrodes, connected to the electronic components, for delivering stimulus pulses to a subjacent tissue.

[0256] The functional components may be partly or entirely separable from the structural components, or the functional components may be only partially separable. The functional components and structural components may form a single construct, thereby rendering the functional components entirely non-separable from the structural components. For example, a functional device may comprise electronic components encapsulated in a polymer, wherein the polymer is moulded around the electronic components.

[0257] The functional components may comprise one or more of, circuit boards, electronic components (for example processors), energy storage devices, energy generation devices and so on. In one embodiment, the functional components may comprise one or more devices intended to diagnose, treat or otherwise modify the activity, functioning or physical properties of a biological tissue, biological fluid or physiological system. Such devices may include, but are not limited to, electrodes (for example electrodes for recording electrical or electrophysiological signals, or for delivering or receiving electrical charge), electromagnets, optical emitters or receivers, pressure sensors, chemical sensors, mechanical, electromechanical or microelectromechanical devices including ultrasonic emitters or receivers, fluid or gas pumps and valves, tubes (for example for fluid removal or administration) and so on.

[0258] The tissue may be human tissue or animal tissue. The tissue may be in close proximity to the one or more devices. The tissue may physically contact the one or more devices. The tissue may be remote from the one or more devices. The fluid may be cerebrospinal fluid. The fluid may be blood. The fluid may be other bodily fluids.

[0259] In one embodiment, where the tissue is brain, the tissue may be cerebral cortex. The tissue may be white matter. The tissue may comprise the anatomical structures of the basal ganglia. The tissue may comprise the anatomical structures of the brainstem. The tissue may comprise the cerebellum. The tissue may be white matter. The tissue may be grey matter. The tissue may be a combination of grey and white matter.

[0260] In one embodiment, the functional components comprise one or more devices intended to communicate with a remote device. In another embodiment, the one or more devices comprise devices intended to receive power from, or deliver power to, a remote device. Examples of remote devices may include a mobile telecommunications device such as a mobile phone or other device employing radiofrequency communications technologies. Another example of a remote device may be a hand-held instrument placed over the implant, wherein the instrument sends a signal to the implant such that a device in the implant receives power and data from the instrument. The implant may then return a signal back to the instrument, and the instrument may process that signal.

[0261] The one or more functional components may comprise one or more devices intended to generate power, for example the one or more devices may comprise kinetic energy harvesting technology or biological fuel-cell technology, or other energy-generation technologies amenable to implantation.

[0262] In one embodiment, it may be advantageous to ensure that the locations of the functional components comprising one or more devices intended to diagnose, treat or otherwise modify the activity, functioning or physical properties of a biological tissue matches the anatomy and/or functional topography of the tissue. For example, in one embodiment, wherein the tissue is brain, it may be advantageous that the locations of the one or more devices be aligned with the gyri within the cortical area over which the bone-replacing implant will be placed.

[0263] In yet another embodiment, it may be advantageous that the locations of the one or more functional elements be aligned with functionally-specific regions of, for example, the brain. In this embodiment, functionally-specific regions of, for example, the brain may be identified by the use of imaging devices or techniques including, but not limited to, functional Magnetic Resonance Imaging (fMRI), Magnetoencephalography (MEG) and Positron Emission Tomography (PET). Alternatively, the locations of functionally-specific regions of, for example, the brain may be identified through the prior performance of, for example, cognitive and/or motor tasks during electrophysiological recording with subdural or epidural electrode arrays.

[0264] In one embodiment, wherein the bone-reconstruction implant contains both permanent and removable functional elements, the permanent and removable functional elements may operate independently. In another embodiment, the permanent and removable functional elements perform a combined function.

[0265] Moreover, it may be advantageous that the locations of the one or more functional elements be designed to avoid vascular structures. Alternatively, it may be advantageous for some of the one or more functional elements to deliberately overlay vascular structures, whilst some do not. It should thus be recognised that, given the anatomy of the tissue will vary from one person to another, that the locations of the one or more functional elements is patient specific.

[0266] In one embodiment, wherein the locations of the one or more functional elements is patient specific, the intended locations may predetermined using anatomical data, itself obtained using imaging devices, prior to manufacture of the one or more functional elements. Imaging devices may include magnetic resonance imaging scanners, computed tomography scanners, medical ultrasound systems, one or more lasers, one or more cameras, and other devices known to those skilled in the art to enable the imaging of external or internal anatomy.

[0267] In one embodiment, the one or more functional elements constitutes a brain machine interface, wherein the one or more functional elements facilitates communication between the implant recipient and external technology, for example robotic assistive devices or computers.

[0268] In one embodiment, the one or more functional elements are connected to one or more attachments that extend beyond the borders of the bone-reconstruction implant. For example, FIG. 7 illustrates a cross section of a bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). Attachment (5) is attached to the functional element (4). FIG. 8 illustrates a cross section of a bone reconstruction implant (1) implanted in bone (2). The implant contains void (3) which houses functional element (4). Attachment (5) is attached to the functional element (4).

[0269] In one embodiment the one or more attachments may be permanently connected to the one or more functional elements or the one or more attachments may be detachable. The one or more attachments may be dissolvable or resorbable. One or more of the one or more attachments may penetrate the tissue. One or more of the one or more attachments may rest on the surface of the tissue.

[0270] The one or more attachments may comprise one or more devices intended to diagnose, treat or otherwise modify the activity, functioning or physical properties of a biological tissue, biological fluid or physiological system. Such devices may include, but are not limited to, electrodes (for example electrodes for recording electrical or electrophysiological signals, or for delivering or receiving electrical charge), electromagnets, optical emitters or receivers, pressure sensors, chemical sensors, mechanical, electromechanical or microelectromechanical devices including ultrasonic emitters or receivers, fluid or gas pumps and valves, tubes (for example for fluid removal or administration) and so on. The one or more attachments may comprise one or more devices intended to communicate with a remote device. The one or more attachments may comprise one or more devices intended to receive power from, or deliver power to, a remote device. The one or more attachments may comprise one or more devices intended to generate power.

[0271] The biological tissue may be human tissue or animal tissue. The tissue may be in close proximity to the one or more devices. The tissue may physically contact the one or more devices, for example in the case of electrodes, whereby the electrodes are positioned on a tissue-contacting surface of the attachment. The tissue may be remote from the one or more devices. The fluid may be cerebrospinal fluid. The fluid may be blood. The fluid may be other bodily fluids.

[0272] The form of the one or more attachments may comprise a structure generally regarded as a lead or cable, or a structure generally regarded as a sheet or layer, or a combination thereof. The lead or cable may be thin, for example the lead or cable may be less than 1 mm in diameter, or the lead or cable may be between 1 mm in diameter and 3 mm in diameter. The lead or cable may be larger than 3 mm in diameter. The sheet or layer may comprise one or more sub-layers, that is the sheet may be laminar in structure. The sheet or layer may be connected to the one or more devices in the bone replacing implant by means of a cable or wire. The sheet or layer may be connected by means of a highly flexible, narrower sheet, such as would be generally regarded as a ribbon cable. The one or more attachments may comprise combinations of sheets and cables.

[0273] The lead, cable, sheet or layer may comprise, for example, a thermoplastic material. The lead, cable, sheet or layer may be made of silicone, polytetrafluoroethylene, polyurethane or other suitable biocompatible materials.

[0274] The lead, cable, sheet or layer may be flexible. The lead, cable, sheet or layer may be elastic. The lead, cable, sheet or layer may be biodegradable. The lead, cable, sheet or layer may be biostable. The lead, cable, sheet or layer may be curved.

[0275] In one embodiment the lead, cable, sheet or layer may be shaped to conform to part of a patient's internal anatomy.

[0276] The lead, cable, sheet or layer may be manufactured as a pre-shaped form. They may be pre-shaped to conform to the surface contours of internal patient anatomy. For example, the sheet may not be a flat sheet that has been curved in a single dimension, but rather a sheet that has been manufactured to substantially conform to the contours of patient anatomy. For example, the sheet may be substantially dome shaped so as to conform to a respective dome shaped contour of internal patient anatomy. The sheet and the contour of patient internal anatomy may have a substantially hand and glove relationship.

[0277] In one embodiment wherein one or more attachments comprises one or more devices, it is advantageous to ensure that the locations of the one or more devices matches the anatomy and/or functional topography of the tissue. It should thus be recognised that, given the anatomy of the tissue will vary from one person to another, that the locations of the one or more devices is patient specific. When the locations of the one or more devices is patient specific, the intended locations may predetermined using anatomical data, itself obtained using imaging devices, prior to manufacture of the one or more attachments. Imaging devices may include magnetic resonance imaging scanners, computed tomography scanners, medical ultrasound systems, one or more lasers, one or more cameras, and other devices known to those skilled in the art to enable the imaging of external or internal anatomy.

[0278] In yet another embodiment, it may be advantageous that the locations of the one or more devices be aligned with functionally-specific regions of, for example, the brain. In this embodiment, functionally-specific regions of, for example, the brain may be identified by the use of imaging devices or techniques including, but not limited to, functional Magnetic Resonance Imaging (fMRI), Magnetoencephalography (MEG) and Positron Emission Tomography (PET). Alternatively, the locations of functionally-specific regions of, for example, the brain may be identified through the prior performance of, for example, cognitive and/or motor tasks during electrophysiological recording with subdural or epidural electrode arrays.

[0279] In certain circumstances, the shape or anatomy of a tissue or bodily structure that is in ordinarily in close proximity to a bony structure may alter over time. Examples of such circumstances include, but are not limited to, the atrophy of brain tissue, or encephalomalacia that may occur after brain trauma, stroke, or a neurosurgical procedure. In such cases, the distance from the brain surface to the inner surface of the skull, or the skull defect introduced by the performing of a decompressive craniectomy, may alter over time.

[0280] It will be appreciated that it may be advantageous that the one or more devices or one or more attachments remain in close proximity to the tissue, in order to maintain their ability to perform their intended function. Thus, in one embodiment of the device described herein, the one or more attachments are highly flexible, or any leads or ribbon cables connecting the one or more attachments are extendable or possess sufficient excess length to permit extension without stretching. In another embodiment, in which the one or more attachments comprise a sheet, the contour of the sheet may be dynamically altered to fill any void that exists or develops between the sheet and the tissue. In still another embodiment, the contour or anatomy of the bone reconstruction implant does not replicate the original anatomy of the bone it is intended to replace. In this embodiment, the contour of the bone-reconstruction implant is designed, prior to manufacture, to ensure maximal contact with an adjacent or surrounding tissue, for example, wherein the tissue has moved from its usual anatomical position. An example of this embodiment is shown in FIG. 9 where implant (7) affords maximum contact with adjacent skull bone (9), dura (8) and brain (6).

[0281] In one embodiment of the bone-reconstruction implant containing a void for one or more devices, the one or more devices may comprise one or more reservoirs. The one or more reservoirs may have walls that are elastic or deformable, or the walls may be rigid. The one or more reservoirs may be empty at the time of implantation. The one or more reservoirs may contain a fluid at the time of implantation. The one or more reservoirs may be under vacuum at the time of implantation. The fluid may be sterile. The fluid may be a therapeutic substance. The fluid may be a vasoactive substance. The fluid may be any substance that is known to influence the functioning of biological tissues, biological fluids or physiological systems. The fluid may be a CSF-mimicking fluid. The fluid may be a blood-mimicking fluid. The one or more reservoirs may be connected to one more devices intended to allow the movement of fluid from one location to another. For example, in one embodiment the reservoir may be connected to a pump and tube, wherein the tube provides a fluid path from the cerebral ventricles to the reservoir and the pump serves as a means with which to move the fluid from the cerebral ventricles to the reservoir. In another embodiment, the reservoir, may have deformable walls made of a polymer or otherwise flexible/elastic substance, and is able to be penetrated by a needle for the purposes of withdrawing cerebrospinal fluid. In yet another embodiment, the combination of one or more reservoirs, one or more valves, one or more pressure sensors, one or more tubes, one or more pumps and one or more other devices constitutes a device for the diversion of cerebrospinal fluid from the cerebral ventricles to an extracranial location, for example the atrium of the heart or the peritoneal cavity.

[0282] FIG. 10 illustrates, in cross section, a system comprising a bone reconstruction implant and an external device. Bone reconstruction implant (1) implanted in bone (2) contains functional element (4) which is in electronic communication with functional element (6) in external device (5). The external device may be a wearable device and its surface (7) may be customized so that its contours match those of external patient anatomy.

[0283] FIG. 11 illustrates, in cross section, a system in which a functional element (6) in implanted device (5) is misaligned with functional element (4) in bone reconstruction implant (1). The centre of the functional element in the implanted device is offset from the centre of the functional element in the bone reconstruction implant by a distance of Z. Misalignment may occur in any direction. The functional elements are misaligned so that the overlap in at least one respective surface is zero. The functional element in the bone reconstruction implant and the functional element in the implanted device are also misaligned as the centre of the functional element in the bone reconstruction implant and the centre of the functional element in the implanted device are offset from each other (distance Z) by more than 100%, relative to the largest dimension of the functional element in the bone reconstruction device.

[0284] FIG. 12 illustrates a system in which a functional element (6) in implanted device (5) is angularly misaligned with functional element (4) in bone reconstruction implant (1). The centre of the functional element in the implanted device is offset from the centre of the functional element in the bone reconstruction implant by a distance of Z and the direction of a longitudinal axis through functional element (6) is offset from the direction through a longitudinal axis through functional element (4) by an angle theta. Misalignment may occur in any direction.

[0285] FIG. 13 illustrates a system comprising bone reconstruction implant (1) implanted in bone (2) and containing functional element (4) and implanted device (5) containing functional element (6). The implanted device (5) is implanted in the patient's body. The implanted device (5) is physically connected or wirelessly connected with implanted devices (7) and (9) which respectively contain functional elements (8) and (10). The implanted devices may form part of a single, larger device. Functional elements (4) and (6) facilitate the transfer of energy between the two as denoted by the double arrow. The energy transferred between functional elements (4) and (6) may be for the purposes of providing power, transferring information or other functions as appropriate to the operation of the device. The alignment between functional elements (4) and (6) is optimised to ensure maximum efficiency of energy transfer between the two.

[0286] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient and said implant being contoured in one or more further surface regions, said contouring being based on patient specific computer imaging data, so that said one or more further surface regions match or substantially match one or more surface contours of a patient's internal anatomy.

[0287] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient and said implant being contoured in one or more further surface regions, said contouring being based on patient specific computer imaging data, so that said one or more further surface regions match or substantially match one or more surface contours of a patient's internal anatomy, said implant comprising one or more voids within which the one or more functional elements are located.

[0288] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient and said implant being contoured in one or more further surface regions, said contouring being based on patient specific computer imaging data, so that said one or more further surface regions match or substantially match one or more surface contours of a patient's internal anatomy, said implant comprising one or more voids within which the one or more functional elements are located, said one or more voids spanning the full thickness of at least one dimension of said implant.

[0289] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient; said implant being contoured in one or more further surface regions, said contouring being based on patient specific computer imaging data, so that said one or more further surface regions match or substantially match one or more surface contours of a patient's internal anatomy, said implant comprising one or more voids within which the one or more functional elements are located, said one or more voids spanning a partial thickness of at least one dimension of said implant.

[0290] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient and said one or more functional elements being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a patient's internal anatomy.

[0291] In an exemplary embodiment the present disclosure provides a bone reconstruction implant, said implant comprising one or more functional elements, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient and said one or more functional elements being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a patient's internal anatomy, said implant comprising one or more voids within which the one or more functional elements are located.

[0292] In an exemplary embodiment the present disclosure provides a system for monitoring the health of a patient and/or modulating the health of a patient, said system comprising: [0293] (a) at least one bone reconstruction implant said implant being implanted to correct a bony defect in said patient, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient; and [0294] (b) at least one other device internal and/or external to said patient's anatomy;
said at least one other device comprising one or more functional elements;
wherein at least one functional element in the bone reconstruction implant and at least one functional element in the at least one other device are in electronic communication.

[0295] In an exemplary embodiment the present disclosure provides a system for monitoring the health of a patient and/or modulating the health of a patient, said system comprising: [0296] (a) at least one bone reconstruction implant said implant being implanted to correct a bony defect in said patient, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient; and [0297] (b) at least one external device positioned on said patient's external anatomy; said at least one external device comprising one or more functional elements;
wherein at least one functional element in the bone reconstruction implant and at least one functional element in the at least one external device are in electronic communication.

[0298] In an exemplary embodiment the present disclosure provides a system for monitoring the health of a patient and/or modulating the health of a patient, said system comprising: [0299] (a) at least one bone reconstruction implant said implant being implanted to correct a bony defect in said patient, said implant being contoured in one or more surface regions, said contouring being based on patient specific computer imaging data, so that said one or more surface regions match or substantially match one or more surface contours of a bony defect in said patient; and [0300] (b) at least one other device internal and/or external to said patient's anatomy; said at least one other device comprising one or more functional elements;
wherein at least one functional element in the bone reconstruction implant and at least one functional element in the at least one other device are in electronic communication, wherein the at least one functional element in the bone reconstruction implant is substantially aligned with an internal anatomical feature of said patient.

[0301] It is contemplated that the devices, methods and systems described herein may find use in a wide range of applications, where implants are required. Thus, where it is desired to deliver healthcare to other parts of the anatomy, the devices, methods and systems of the present disclosure may be used.

[0302] It is to be understood that while the present disclosure has been described in conjunction with the specific embodiments thereof, the foregoing description is intended to illustrate and not limit the scope of the disclosure. Other aspects, advantages and modifications will be apparent to those skilled in the art to which the disclosure pertains. Therefore, the above examples are put forth so as to provide those skilled in the art with a complete disclosure and description of how to make and use the disclosed devices, and are not intended to limit the scope of the disclosure.

[0303] For the sake of brevity, only certain ranges are explicitly disclosed herein. However, ranges from any lower limit may be combined with any upper limit to recite a range not explicitly recited, as well as, ranges from any lower limit may be combined with any other lower limit to recite a range not explicitly recited, in the same way, ranges from any upper limit may be combined with any other upper limit to recite a range not explicitly recited.

[0304] All documents cited are herein fully incorporated by reference for all jurisdictions in which such incorporation is permitted and to the extent such disclosure is consistent with the description of the present disclosure.