WO2017024346A1

WO2017024346A1 - Systems and methods for designing and manufacturing medical devices

Info

Publication number: WO2017024346A1
Application number: PCT/AU2016/050720
Authority: WO
Inventors: Jeremy Travis KWARCINSKI; David Shen; Annabelle Helen CHAN; Fangli JIA; Phillip Charles BOUGHTON; James VAN GELDER; Andrew John Ruys
Original assignee: The University Of Sydney
Priority date: 2015-08-10
Filing date: 2016-08-10
Publication date: 2017-02-16

Abstract

Described herein are systems and methods for designing and manufacturing medical devices. The method of manufacturing a medical device includes obtaining a patient scan, processing the patient scan to extract patient specific data, creating a template based on the patient specific data, and forming a patient specific medical device, such as a Patient Specific Implant (PSI), a Patient Specific Anatomical Model (PSAM), or a Patient Specific Medical Instrument (PSMI), using the template.

Description

SYSTEMS AND METHODS FOR DESIGNING AND MANUFACTURING

MEDICAL DEVICES

FIELD OF THE INVENTION

[0001 ] The present invention relates to medical devices and in particular to systems and methods for designing and manufacturing medical devices.

[0002] Embodiments of the invention have been particularly developed for designing and manufacturing medical devices such as anatomical implants and models, and medical instruments. While some embodiments will be described herein with particular reference to these applications, it will be appreciated that the invention is not limited to such a field of use, and is applicable in broader contexts.

BACKGROUND

[0003] Any discussion of the background art throughout the specification should in no way be considered as an admission that such art is widely known or forms part of common general knowledge in the field.

[0004] The implant industry currently focuses on a very modular system. Conventional implants are made of multiple components in generic sizes, with the closet fitting combination being used for patient treatment. Similarly, conventional medical instruments are made in generic sizes.

[0005] Basic and currently accepted bioengineering materials for conventional implants include bone-cement for cranioplasty.

[0006] The logistics cycle of conventional implants is one of a generic, high-volume production system. Due to these existing generic, high-volume production systems, manufacturing companies, including major multinationals, are actively seeking ways to reduce implant inventories and recycle unused parts.

[0007] From an implant perspective, the best treatments are the ones that mimic the natural body to the greatest extent. For Patient Specific Implants (PSI), current industry focus is on the implant rather than the patient. That is, there is a focus on creating a system that tailors the patient to the implant. [0008] Conventional implants, which are not properly custom fitted to a patient, are at risk of migrating and can result in infection and morbidity. Conventional generic sized medical instruments which are not correctly sized for a particular medical procedure are problematic. In particular, generic sized medical instruments are problematic in applications and surgical procedures where size is a constraint. Examples of applications and procedures where generic sized medical instruments are problematic include pediatric surgery and ocular surgery.

SUMMARY OF THE INVENTION

[0009] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.

[0010] Embodiments of the present invention seek to provide systems and methods that produce medical devices such as anatomical implants and models in which the focus is on a system that tailors the implants and models to the patient. This is in contrast with conventional systems that tailor the patient to the implants due to existing conventional generic sized implants.

[001 1 ] One embodiment provides a method for forming a patient-personalised medical device, the method including:

i) selecting a non-personalised size variation of a medical device, wherein the non- personalised size variation of the medical device is selected based upon known size information for a patient, wherein at least a surface-proximal portion of the non-personalised size variation of the medical device is formed of a compressibly mouldable material, wherein the non-personalised size variation of the medical device is provided in a sterilized form having a liner for protecting an outer surface of the non-personalised size variation of the medical device;

ii) forming a patient-personalised moulding template based on patient specific measurement data;

iii) placing the formed patient-personalised moulding template into a compression mould device; and

iv) applying a compression moulding operation to the non-personalised size variation of the medical device in the compression mould device, thereby compressing the surface-proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient- personalised medical device. [0012] One embodiment provides a system for forming a patient-personalised medical device, the system including:

a compression mould device configured to receive a patient-personalised moulding template, wherein:

the patient-personalised moulding template is formed based on patient specific measurement data;

the patient-personalised moulding template is configured to receive a non- personalised size variation of a medical device, wherein the non-personalised size variation of the medical device is selected based upon known size information for a patient, wherein at least a surface-proximal portion of the non-personalised size variation of the medical device is formed of a compressibly mouldable material, wherein the non-personalised size variation of the medical device is provided in a sterilized form having a liner for protecting an outer surface of the non-personalised size variation of the medical device; and

a compression moulding operation is applied to the non-personalised size variation of the medical device, which is placed in the patient-personalised moulding template, in the compression mould device, thereby compressing the surface-proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient- personalised medical device.

[0013] One embodiment provides a method of manufacturing a patient-personalised medical device including:

creating a patient-personalised moulding template based on a set of patient specific measurement data points;

adding a compressibly mouldable material to a cavity of the template, wherein a liner is positioned between the template cavity and the material thereby to protect an outer surface of the material; and

compressing the material in the template thereby to transform the material into a patient-personalised medical device.

[0014] One embodiment provides a method including:

using a scanning device to obtain a patient scan; and

processing the patient scan thereby to extract the set of patient specific measurement data points from the patient scan. [0015] One embodiment provides a method wherein the patient scan is processed using computer imaging software.

[0016] One embodiment provides a method wherein the liner forms a protective barrier between the template cavity and the material.

[0017] One embodiment provides a method wherein the liner includes a texture that is transferred to the patient-personalised medical device during compression of the material in the template.

[0018] One embodiment provides a method wherein the liner includes a coating that is transferred to the patient-personalised medical device during compression of the material in the template.

[0019] One embodiment provides a method wherein the material and/or the liner are pre- sterilised.

[0020] One embodiment provides a method wherein the material is pre-packaged in the liner.

[0021 ] One embodiment provides a method wherein the material is a non-personalised generic implant, a non-personalised generic model or raw formation material.

[0022] One embodiment provides a method wherein the patient-personalised medical device is a patient specific implant.

[0023] One embodiment provides a method wherein the patient-personalised medical device is a patient specific anatomical model.

[0024] One embodiment provides a system for manufacturing a patient-personalised medical device including:

a printing device configured to create a patient-personalised moulding template based on a set of patient specific measurement data points, wherein a compressibly mouldable material is added to a cavity of the template and a liner is positioned between the template cavity and the material thereby to protect an outer surface of the material; and

a compression mould device configured to compress the material in the template thereby to transform the material into a patient-personalised medical device.

[0025] One embodiment provides a system including:

a scanning device configured to obtain a patient scan; and imaging software configured to process the patient scan thereby to extract the set of patient specific measurement data points from the patient scan.

[0026] One embodiment provides a system wherein the liner forms a protective barrier between the template cavity and the material.

[0027] One embodiment provides a system wherein the liner includes a texture that is transferred to the patient-personalised medical device during compression of the material in the template.

[0028] One embodiment provides a system wherein the liner includes a coating that is transferred to the patient-personalised medical device during compression of the material in the template.

[0029] One embodiment provides a system wherein the material and/or the liner are pre- sterilised.

[0030] One embodiment provides a system wherein the material is pre-packaged in the liner.

[0031 ] One embodiment provides a system wherein the material is a non-personalised generic implant, a non-personalised generic model or raw formation material.

[0032] One embodiment provides a system wherein the patient-personalised medical device is a patient specific implant.

[0033] One embodiment provides a system wherein the patient-personalised medical device is a patient specific anatomical model.

[0034] One embodiment provides a method wherein applying the compression moulding operation includes changing a height of the non-personalised size variation of the medical device. In one embodiment the height is defined by the patient-personalised moulding template.

[0035] One embodiment provides a method wherein applying the compression moulding operation includes changing a geometry of the non-personalised size variation of the medical device. In one embodiment the geometry is defined by the patient-personalised moulding template.

[0036] One embodiment provides a method wherein applying the compression moulding operation includes changing a lateral dimension of the non-personalised size variation of the medical device. [0037] One embodiment provides a method wherein applying the compression moulding operation includes changing an anterior-posterior dimension of the non-personalised size variation of the medical device.

[0038] One embodiment provides a method wherein applying the compression moulding operation includes changing an anatomic angular transformation of the non-personalised size variation of the medical device.

[0039] One embodiment provides a method wherein applying the compression moulding operation includes changing the height, the geometry, the lateral dimension, the anterior- posterior dimension and the anatomic angular transformation of the non-personalised size variation of the medical device substantially simultaneously.

[0040] One embodiment provides a system wherein the compression moulding operation includes changing a height of the non-personalised size variation of the medical device. In one embodiment the height is defined by the patient-personalised moulding template.

[0041 ] One embodiment provides a system wherein the compression moulding operation includes changing a geometry of the non-personalised size variation of the medical device. In one embodiment the geometry is defined by the patient-personalised moulding template.

[0042] One embodiment provides a system wherein the compression moulding operation includes changing a lateral dimension of the non-personalised size variation of the medical device.

[0043] One embodiment provides a system wherein the compression moulding operation includes changing an anterior-posterior dimension of the non-personalised size variation of the medical device.

[0044] One embodiment provides a system wherein the compression moulding operation includes changing an anatomic angular transformation of the non-personalised size variation of the medical device.

[0045] One embodiment provides a system wherein the compression moulding operation includes changing the height, the geometry, the lateral dimension, the anterior-posterior dimension and the anatomic angular transformation of the non-personalised size variation of the medical device substantially simultaneously. [0046] One embodiment provides a method wherein compressing the material includes transforming a height of the material. In one embodiment the height is defined by the patient- personalised moulding template.

[0047] One embodiment provides a method wherein compressing the material includes transforming a geometry of the material. In one embodiment the geometry is defined by the patient-personalised moulding template.

[0048] One embodiment provides a method wherein compressing the material includes transforming a lateral dimension of the material. One embodiment provides a method wherein compressing the material includes transforming an anterior-posterior dimension of the material. One embodiment provides a method wherein compressing the material includes transforming an anatomic angular transformation of the material.

[0049] One embodiment provides a method wherein compressing the material includes transforming the height, the geometry, the lateral dimension, the anterior-posterior dimension and the anatomic angular transformation of the material substantially simultaneously.

[0050] One embodiment provides a system wherein compression of the material includes transforming a height of the material. In one embodiment the height is defined by the patient- personalised moulding template.

[0051 ] One embodiment provides a system wherein compression of the material includes transforming a geometry of the material. In one embodiment the geometry is defined by the patient-personalised moulding template.

[0052] One embodiment provides a system wherein compression of the material includes transforming a lateral dimension of the material. One embodiment provides a system wherein compression of the material includes transforming an anterior-posterior dimension of the material. One embodiment provides a system wherein compression of the material includes transforming an anatomic angular transformation of the material.

[0053] One embodiment provides a system wherein compression of the material includes transforming the height, the geometry, the lateral dimension, the anterior-posterior dimension and the anatomic angular transformation of the material substantially simultaneously.

[0054] As used herein, the term Patient Specific Implants (PSI) refers to implants designed and produced based on exact patient data, also referred to as patient specific data. [0055] As used herein, the term Patient Specific Anatomical Models (PSAM) refers to anatomical models designed and produced based on exact patient data, also referred to as patient specific data.

[0056] As used herein, the term Patient Specific Medical Instrument (PSMI) refers to medical instruments designed and produced based on exact patient data, also referred to as patient specific data.

[0057] As used herein, reference to the terms "one embodiment", "some embodiments" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment", "in some embodiments" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0058] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[0059] As used herein, any one of the terms "comprising", "comprised of" or "which comprises" should be interpreted as being an open term that means including at least the elements/features that follow, but not excluding others. Thus, the term comprising, when used in the claims, should not be interpreted as being limitative to the means or elements or steps listed thereafter. For example, the scope of the expression a device comprising A and B should not be limited to devices consisting only of elements A and B. Any one of the terms including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

[0060] As used herein, the term "exemplary" is used in the sense of providing examples, as opposed to indicating quality. That is, an "exemplary embodiment" is an embodiment provided as an example, as opposed to necessarily being an embodiment of exemplary quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0061 ] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0062] Figure 1 provides an overview of a method of manufacturing a medical device according to an embodiment of the present invention ;

[0063] Figure 2 illustrates a method of forming an implant according to an embodiment of the invention;

[0064] Figure 3 illustrates a method of forming a polymethylmethacrylate (PMMA) cranioplasty implant according to an embodiment of the invention;

[0065] Figure 4A illustrates a textured liner template according to an embodiment of the invention;

[0066] Figure 4B illustrates a silicone liner template according to an embodiment of the invention;

[0067] Figure 4C illustrates a fabricated textured bag according to an embodiment of the invention;

[0068] Figure 4D illustrates fabricated textured implants according to an embodiment of the invention;

[0069] Figure 4E illustrates a meniscal implant including a liner prior to being compressed in a mould;

[0070] Figure 4F illustrates a meniscal implant including a liner after being compressed in a mould;

[0071 ] Figure 5A illustrates a compression mould without guide pins according to an embodiment of the invention;

[0072] Figure 5B illustrates a mould for meniscal implant formation; [0073] Figure 5C illustrates a mould for brain model production;

[0074] Figure 5D illustrates a compression mould with guide pins according to an embodiment of the invention; [0075] Figure 5E illustrates a compression mould with guide pins according to another embodiment of the invention;

[0076] Figure 5F illustrates a compression mould with guide slides according to an embodiment of the invention;

[0077] Figure 6A illustrates the superficial surface of a meniscal implant following removal of a liner;

[0078] Figure 6B illustrates the posterior surface of the meniscal implant of Figure 6A;

[0079] Figure 6C illustrates the meniscal implant of Figure 6A following removal of excess scaffold;

[0080] Figure 7A illustrates generic specifications of a meniscal implant precursor with meniscus outline;

[0081 ] Figure 7B illustrates a meniscal implant precursor model;

[0082] Figure 7C illustrates a meniscal implant precursor scaffold;

[0083] Figure 7D illustrates a scaffold precursor mould;

[0084] Figure 7E is a top view of a scaffold precursor;

[0085] Figure 7F is a right side view of the scaffold precursor of Figure 7E;

[0086] Figure 8A illustrates an example manual tool for forming a medical device according to an embodiment of the invention;

[0087] Figure 8B illustrates an example automated tool for forming a medical device according to an embodiment of the invention;

[0088] Figure 9A illustrates implant design specifications of a generic spinal fusion cage; [0089] Figure 9B illustrates a 3D printed template of a spinal fusion cage; [0090] Figure 9C illustrates a silicone mould for the fabrication of a spinal fusion cage; [0091 ] Figure 9D illustrates a generic spinal fusion cage; [0092] Figure 10 illustrates a scanning electron microscope (SEM) image of a Ultra High Molecular Weight Polyethylene (UHMWPE) fibre-reinforced pre- impregnated composite tape cross-section;

[0093] Figure 1 1 illustrates use of composite tape;

[0094] Figure 12 illustrates the equipment setup for hot pressing where the silicone mould of Figure 9C is positioned between two constraining metal plates;

[0095] Figure 13 is a diagram illustrating stresses exerted by constraining components on a wrapped composite tape during hot pressing;

[0096] Figure 14 illustrates a generic composite cage with spiral indentation;

[0097] Figure 15A illustrates the silicone mould and metal plates of Figure 12 being compressed in an axial transformation vice for axial geometry transformation of a spinal fusion cage;

[0098] Figure 15B is a side view of various spinal fusion cages;

[0099] Figure 15C is a top view of the spinal fusion cages in Figure 15B;

[00100] Figure 16A illustrates the silicone mould and metal plates of Figure 12 being compressed in an angled transformation vice for angled transformation of a spinal fusion cage;

[00101 ] Figure 16B is a side view of various spinal fusion cages;

[00102] Figure 17 A illustrates a twin blade fixation system for a spinal fusion cage;

[00103] Figure 17B illustrates the twin blade fixation system of Figure 17A acting as a self- locking mechanism; and

[00104] Figure 18 illustrates a system according to an embodiment of the invention. DETAILED DESCRIPTION

[00105] The following description and Figures make use of reference numerals to assist the addressee understand the structure and function of the illustrated embodiments. Like reference numerals are used in different embodiments to designate features having the same or similar function and/or structure. [00106] The drawings need to be viewed as a whole and together with the associated text in this specification. In particular, some of the drawings selectively omit features to provide greater clarity about the specific features being described. While this is done to assist the reader, it should not be taken that those features are not disclosed or are not required for the operation of the relevant embodiment.

[00107] Described herein are systems and methods for designing and manufacturing medical devices, such as Patient Specific Implants (PSI), Patient Specific Anatomical Models (PSAM) and Patient Specific Medical Instruments (PSMI). For example, a method for forming a patient- personalised medical device includes selecting a non-personalised size variation of a medical device. The non-personalised size variation of the medical device is selected based upon known size information for a patient and at least a surface-proximal portion of the non- personalised size variation of the medical device is formed of a compressibly mouldable material. The non-personalised size variation of the medical device is provided in a sterilized form having a liner for protecting an outer surface of the non-personalised size variation of the medical device. The method further includes forming a patient-personalised moulding template based on patient specific measurement data and placing the formed patient-personalised moulding template into a compression mould device. Furthermore, the method includes applying a compression moulding operation to the non-personalised size variation of the medical device in the compression mould device, thereby compressing the surface-proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient-personalised medical device.

[00108] An example system for forming a patient-personalised medical device includes a compression mould device configured to receive a patient-personalised moulding template. The patient-personalised moulding template is formed based on patient specific measurement data and the patient-personalised moulding template is configured to receive a non-personalised size variation of a medical device. The non-personalised size variation of the medical device is selected based upon known size information for a patient and at least a surface-proximal portion of the non-personalised size variation of the medical device is formed of a compressibly mouldable material. The non-personalised size variation of the medical device is provided in a sterilized form having a liner for protecting an outer surface of the non-personalised size variation of the medical device. A compression moulding operation is applied to the non- personalised size variation of the medical device, which is placed in the patient-personalised moulding template, in the compression mould device, thereby compressing the surface- proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient- personalised medical device.

[00109] A compression mould device and a compression moulding operation as discussed throughout the specification includes, but is not intended to be limited to, compression mould devices and compression moulding operations in the traditional sense. Rather, throughout the specification discussions utilising terms such as "compress", "compression", "compressing", "compressed" or the like refer to an action or process involving the application of pressure, force or otherwise to transform or change the geometrical shape of an object. It will be appreciated that the use of such terms is not intended to be limited to compression or transformation in a specific direction. Rather, it will be appreciated that compression or transformation of a pre-formed generic medical device or material using methods and systems as herein disclosed include any variation of contraction and/or expansion in one or multiple dimensions. That is, embodiments of the present invention, are capable of transforming (using a rigid or flexible mould as described) raw material and pre-formed generic implants, models and instruments not only by compression moulding, in the traditional sense, to set height and geometry as defined by a template, but also simultaneously adjusting the lateral and anterior- posterior dimensions, and any anatomic angular transformation.

[001 10] Accordingly, a compression mould device as disclosed herein includes devices adapted or otherwise configured to transform an object or material to set height and geometry, as well as adjust dimensions including lateral, anterior-posterior and anatomic angular transformation and the like. Similarly, a compression moulding operation as disclosed herein includes one or more operations to transform an object or material to set height and geometry, as well as adjust dimensions including lateral, anterior-posterior and anatomic angular transformation and the like.

[001 1 1 ] It will be appreciated that, in one embodiment, compression of an object or material includes the application of a restrictive force in one or more directions resulting in expansion of the material in one or more other directions. The systems and methods disclosed herein are thus used to design and manufacture medical devices, and in particular, patient-personalised medical devices, such as Patient Specific Implants (PSI), Patient Specific Anatomical Models (PSAM) and Patient Specific Medical Instruments (PSMI). In one embodiment, simultaneously adjusting lateral and anterior-posterior dimensions, and any anatomic angular transformation accounts for restoring spinal lumbar curvature via a flexible template system. Embodiments of the invention disclose geometrical transformation via templating to transform material into a patient-personalised medical device. [001 12] While some embodiments will be described herein with particular reference to producing a Patient Specific Implants (PSI), Patient Specific Anatomical Models (PSAM) or Patient Specific Medical Instruments (PSMI), it will be appreciated that embodiments of the invention are intended to be applicable to producing any one of a PSI, PSAM or PSMI.

[001 13] Figure 1 provides an overview of a method of manufacturing a medical device 100, for example Patient Specific Implants (PSI), Patient Specific Anatomical Models (PSAM) and Patient Specific Medical Instruments (PSMI), according to an embodiment of the present invention. The method includes obtaining a patient scan 101 , processing the patient scan to extract patient specific data 102, creating a template based on the patient specific data 103, and forming a medical device, such as a PSI, a PSAM, or a PSMI, using the template 104. In one embodiment, the template is a mould. In other embodiments, the template is a replication anatomy.

[001 14] The patient scan may be obtained using any form of medical scanning device and method. In an exemplary embodiment, the patient scan, from which patient specific data is extracted, is processed through computer imaging and CAD software, including, but not limited to, CAD software marketed under the brand names Amira, Scan IP and Solidworks. In other embodiments, it will be appreciated that the patient scan is processed using other manners and other methods. A template, for example a compression mould or replication anatomy, is created based on the patient specific data. The compression mould or replication anatomy is used in fabrication of a PSI, a PSAM, or PSMI. In one embodiment, a mould is created using 3D printing technology, for example, desktop FDM 3D printing systems. However, it will be appreciated that other 3D printing technologies are used in other embodiments. In another embodiment, an anatomical model is used for creating the mould, for example silicone moulds. However, it will be appreciated that materials other than silicone are used for moulds in other embodiments. In some embodiments the mould is rigid. In other embodiments the mould is flexible.

[001 15] Although the templates illustrated and described in the examples are for a specific number of parts and are in specific orientations, it will be appreciated that the templates, in other embodiments, are for any number of parts and are in any orientation.

[001 16] This process used in fabrication of a PSI, a PSAM, or PSMI includes the creation of an optimisation algorithm to reach a "sweet spot" between model resolution, available computing power and processing time. [001 17] The mould or replication anatomy used to form a PSI, a PSAM, or PSMI is also referred to more generally throughout the specification as a template. As such, in some instances, the method of forming a PSI, a PSAM, or PSMI as described herein is referred to a template method or templating method for producing a medical device, such as an anatomical implant or model, or medical instrument, and in particular a PSI, a PSAM, or PSMI. Furthermore, in some instances, the template method or templating method is referred to as a rapid template method or rapid templating method due to the speed in which PSI, PSAM and PSMI may be manufactured using the systems and methods disclosed herein. The systems and methods disclosed herein provide rapid templating techniques that generate custom implants with minimal delays. Fabrication of the custom patient specific medical devices in accordance with the systems and methods disclosed herein include the application of the templating process to sterile, packaged materials, minimising extended sterilisation delays. Accordingly, the systems and methods disclosed herein provide rapid templating techniques resulting in a templated medical device being rapidly produced or formed in-surgery or the like and in some embodiments without the need for any additional cleaning or sterilisation steps as will be discussed in more detail. In some embodiments, the template is created based on the patient specific data. Accordingly, in those embodiments, the template may also be referred to as a patient-personalised moulding template.

[001 18] It will be appreciated that the systems and methods disclosed herein are used to produce anatomical implants and models of any area of the body.

[001 19] It will also be appreciated that the systems and methods disclosed herein are used to produce patient-personalised medical instruments. For example, in pediatric surgery and ocular surgery generic medical instruments are not suitable for all patients. Accordingly, the templating systems and methods disclosed herein are used to produce patient-personalised medical instruments for use during surgical procedures. The rapid templating techniques disclosed herein result in patient-personalised medical instruments being produced more quickly and more efficiently than existing techniques.

[00120] Some embodiments of the present invention make use of Rapid Prototyping (RP) methods and Direct Digital Manufacturing (DDM). This may include 3D fused deposition moulding printing, stereo lithography methods, selective laser sintering, and Computer Numerical Control (CNC) milling.

[00121 ] As medical devices including PSI, PSAM and PSMI formed in accordance with the methods and systems described herein are designed and produced based on patient specific data, such medical devices may be referred to as patient-personalised medical devices. [00122] Figure 2 illustrates a method of forming an implant 200 according to one exemplary embodiment of the invention. The steps illustrated in Figure 2 provide further detail on the steps of creating a template based on the patient specific data 103 and forming a PSI or a PSAM using the template 104, as illustrated in Figure 1 .

[00123] In the exemplary embodiment illustrated in Figure 2, the step of creating a mould or template based on the patient specific data 103 includes the steps of manufacturing a custom implant template 201 based on the patient specific data or exact patient data, sterilising the custom implant template 202, and pre-treating the sterilised custom implant template 203. In some embodiments, the step of pre-treating the sterilised template is not required. That is, in some embodiments, the step of sterilising the template 202 progresses directly 204 to the step of forming a medical device using the template 104.

[00124] The step of forming a PSI using the template 104 includes the steps of adding material to the template cavity 205, compressing the template 206, treating the implant 207, decompressing the template and removing the implant 209 and completing implant postprocessing and implantation 210. In some embodiments, raw material is added to the template cavity 205 and the raw material is compressed in the template to form the PSI. In other embodiments, a pre-formed generic implant or model is added to the template cavity 205. In the case where a pre-formed generic implant is added to the template cavity, the generic implant is compressed in the custom implant template to form the PSI. In the case where a preformed generic model is added to the template cavity, the generic model is compressed in the custom implant template to form a PSAM. In embodiments of the invention, it will be appreciated that the raw material and pre-formed generic medical devices, such as pre-formed generic implants and models, and medical instruments, include an antibacterial agent and/or antibacterial material. In some embodiments off the shelf antibacterial materials are used. It will be appreciated that materials other than raw material and pre-formed generic implants and models are used in other embodiments.

[00125] In some embodiments, the step of treating the implant 207 is not required. Accordingly, the step of compressing the template 206 progresses directly 208 to the step of decompressing the template and removing the implant 209.

[00126] Generic implants and models used to create patient personalised medical devices may be pre-formed in a variety of predetermined sizes. These generic implants and models may be referred to as non-personalised medical devices. [00127] In some embodiments, a liner is positioned between the template cavity and the material. However, it will be appreciated that a liner is not used in all embodiments.

[00128] In some embodiments, the material is pre-sterilised. In other embodiments, the material is pre-packaged in a liner. In some embodiments, the liner protects an outer surface of the material. In further embodiments, the material is both pre-sterilised and pre-packaged in a liner. In some embodiments, the liner may be pre-sterilised. It will be appreciated that other variations and combinations of liners, pre-sterilisation and pre-packing may be applied and used in other embodiments.

[00129] Figure 3 illustrates a method of forming a polymethylmethacrylate (PMMA) cranioplasty implant 300 according to an embodiment of the invention. The method 300 makes use of the templating method 200 and includes the steps of: mixing PMMA bone cement 301 , applying protective membrane to the mould 302, applying PMMA to the mould 303, compression of the mould 304, removal of the PMMA implant from the mould 305, post processing of the PMMA implant 306, and surgical fixation of the PMMA implant to a cranial defect 307.

[00130] Depending on the application, bone/tissue quality and age of the patient and the size of the defect, a range of other material systems could be used, for example, those that set like cements (i.e. thermosets) or are thermoplastic or ductile and strain-hardening in nature.

[00131 ] For example, in polymeric graft systems, polymer or polymer composite biomaterials that may be used include perforated plate or porous polyetheretherketone (PEEK), polyethylenimine (PEI), porous polyethylene: e.g. materials marketed under the brand names Medpor Medstar, and biostable thermosetting or thermoplastic polyurethanes (i.e. perforated plate or porous scaffold made from materials marketed under the brand names Elast-Eon by AorTech or Biodegradable Temporising Matrix (BTM) by PolyNovo - i.e. silastic modified urethane and biodegradable polyurethane respectively) or bioresorbable aliphatic polyester composite scaffold (e.g. material marketed under the brand name Variotis by Biometic).

[00132] In ceramic based graft systems, materials which may be used include: amorphous calcium phosphate and/or hydroxyapatite and/or bioactive glass graft with bioresorbable thermoplastic matrix/binder composed of one or more blends of bioresorbable polyurethane, polylactide, polyglycolide, or aliphatic polyester. Carbohydrate and protein derived polymers or biopolymer systems may also be used. [00133] In bioresorbable metallic graft systems there are relatively new bioresorbable pure iron, magnesium, and MgZnCa "metallic glasses" that may be used with the method disclosed herein, particularly where mechanical rigidity is required initially before degradation occurs invivo. The latter MgZnCa material can be thermoplastically formed at 120 to 160 degrees to then set to a rigid strong metallic glass at body temperature, then gradually resorb, eluting a combination of Mg, Zn and Ca. A polymeric envelope would attenuate the release of the ions to ensure control of degradation and optimal biocompatibility.

[00134] The aforementioned material systems may be formed as perforated or textured plates, 3D porous foam scaffolds or 2D or 3D meshes or 3D woven fabric, or comingled fibre composites, or interconnective granules or combinations of granules with mesh plates or fibrous envelopes or jackets.

[00135] The aforementioned systems can also become a receptor or carrier for patient blood or donor cells, autograft tissues, stem cells, active proteins and other therapeutics. They are best applied minutes before the device is implanted in a patient.

[00136] Referring now to Figure 4C, compression moulds and implant templates designed and created according to the systems and methods described herein allow for the use of a liner 400 to separate the mould from formation material. Use of a liner provides: i) a barrier to assist in sterile PSI or PSAM production;

ii) an isolated area for PSI or PSAM formation material;

iii) the PSI or PSAM with a desired texture transferred through use of the liner; and/or iv) the PSI or PSAM with a desired coating including, but not limited to bioglass and other bioactive agents. This desired coating lines the internal of the liner system and is transferred to the implant during the formation process.

[00137] In one embodiment, the liner is produced from a thin film of various materials including but not limited to low-density polyethylene (LDPE), polypropylene (PP), polyurethane (PU), silicone and metal foils. It will be appreciated that the liner is produced from materials other than those listed above in other embodiments.

[00138] Use of liner systems, which may be referred to in other embodiments as envelope systems or packaging systems, allow terminally sterilised generic implants to be rapidly templated into a PSI. Similarly, in other embodiments, the use of a liner system may be used to rapidly template a pre-sterilised generic model into a PSAM. In further embodiments, the use of a liner system is used to rapidly template terminally sterilised raw material, formation material and the like into a PSI, a PSAM, or a PSMI. Terminally sterilised generic implants, generic models, raw material, formation material, and the like have been subject to or otherwise undergone a terminal sterilisation process whereby the implants, models, or material is sterilised. Thus, rapid templating of ready to go packaged and terminally sterilised precursors using the methods and systems described herein advantageously provide medical devices that are suitable for in-surgery applications.

[00139] Figure 4A illustrates a textured liner template according to one embodiment. However, it will be appreciated that other textures and orientations of textured liners are used in other embodiments. The texture of such liners is transferred or otherwise imprinted on a PSI or PSAM as a result of compression of the formation material while in the mould or template. In other embodiments, it will be appreciated that only a portion of the texture of such liners is transferred or otherwise imprinted on a PSI or PSAM.

[00140] Figure 4B illustrates a silicone liner template according to an embodiment. However, as mentioned above, it will be appreciated that materials other than silicone are used in other embodiments.

[00141 ] Figure 4C illustrates a fabricated textured bag used as a liner 400 according to an embodiment of the invention. Figure 4D illustrates fabricated textured implants formed using the liner 400 illustrated in Figure 4C during the formation process.

[00142] Use of a textured liner, textured envelope or textured packaging and the like, in embodiments of the invention, avoids mechanically and aesthetically deleterious creases, wrinkles and pleats being transferred or otherwise imprinted on a patient-personalised medical device, such as a PSI, PSAM, or PSMI, as a result of compression of the formation material while in the mould or template. Furthermore, inducing a texture on the implant is beneficial for tissue attachment, granular tissue formation on the implant interfaces, avoiding micro-motion and improving fit and engagement in clinical practice when deviation from tolerances can result from scar tissue and bone growth formation occurring post-scans and before implantation. Accordingly, use of such optimised texture template envelopes in embodiments of the invention provides an advantageous aspect.

[00143] In a number of embodiments, textured liners are formed using a sinusoidal texture of varied heights (for example, 0.5mm - 2mm) and widths (for example, 2mm - 4mm). In some embodiments, liners are formed into envelopes, filled with implant material then sealed with minimal residual air. In some embodiments, packaged materials are fabricated into implants using the rapid templating process disclosed herein, allowed to set and removed from packaging and surrounding flash material. In some embodiments, completed implants are assessed aesthetically and geometrically using a 3D scanner. The use of textured liners and/or packaging in accordance with embodiments of the invention at least overcome pleating limitations associated with conventional liners, decrease average number of pleats per implant, provide easier implant removal from template during fabrication process, and maintain high overall geometrical conformance.

[00144] In embodiments of the invention, the formation material is one or more of a blank raw material, solid material, resin, and device, such as a generic implant or generic model. However, it will be appreciated that embodiments of the invention are not limited to these materials and that other formation materials are used in other embodiments.

[00145] Figure 4E illustrates a meniscal implant 401 including a liner 400 prior to being compressed in a mould or template. Figure 4F illustrates the meniscal implant 401 including the liner 400 after being compressed in a mould or template.

[00146] A number of compression moulds produced using the systems and methods described herein are illustrated in Figures 5A to 5F. In particular, Figure 5A illustrates a compression mould 500 without guide pins according to an embodiment of the invention.

[00147] As mentioned above, the systems and methods disclosed herein are used to produce anatomical implants and models of any area of the body. For example, Figure 5B illustrates a mould for meniscal implant formation and Figure 5C illustrates a mould for brain model production.

[00148] In some exemplary embodiments of the invention, compression moulds and implant templates are produced with guide slides and pins for ensuring accurate PSI or PSAM formation. It will be appreciated that methods other than the use of guide slides and pins are used in other embodiments to ensure accurate PSI or PSAM formation.

[00149] Figure 5D illustrates a compression mould 500 with guide pins 501 according to an embodiment of the invention.

[00150] Figure 5E illustrates a compression mould 500 with guide pins 501 according to another embodiment of the invention.

[00151 ] Figure 5F illustrates a compression mould with guide slides 502 according to an embodiment of the invention. [00152] It will be appreciated that other orientations, configurations and combinations of guide pins 501 and guide slides 502 are used as guidance systems in other embodiments of the invention. Guidance systems using guide slides and pins include integrated systems as well as specifically designed external guidance tools.

[00153] Compression moulds and implant templates designed and created according to the systems and methods described herein allow for the formation of a PSI or PSAM with variation in multiple dimensions including at least the following : i) expansion;

ii) thinning / thickening;

iii) alignment of molecules;

iv) alignment of materials; and/or

v) alignment of fibrous or anisotropic composites.

[00154] Compression moulds and implant templates designed and created according to the systems and methods described herein also allow for the inducement of gradients (production of various degrees of distinction) in a PSI or PSAM in regards to at least the following features: i) porosity;

ii) angle gradient;

iii) density;

iv) flexibility; and/or

v) enhanced mechanical stability.

[00155] Furthermore, embodiments of the present invention are capable of inducing a porosity change or gradient, or microstructural change or gradient, or composite phase adjustments or gradients when using a flexible or rigid template system. Accordingly, embodiments of the invention provide material property transformation via the templating systems and methods described herein.

[00156] Furthermore, compression moulds and implant templates designed and created according to the systems and methods described herein allow for the addition of corrugations to a PSI or PSAM as necessary in order to provide at least the following benefits: i) prevent twisting; ii) provide a locking system;

iii) compliment the system with a bioactive filler; and/or

iv) allow for simpler / cleaner adjustment.

[00157] Compression moulds and implant templates designed and created according to the systems and methods described herein also allow for the addition of pins, ribs or additional features within the mould to allow for at least the following: i) air holes within the mould;

ii) perforations / dimples / indicators for model alteration indicators to minimise potential areas of stress concentration; and/or

iii) removal of potential pleats, folds or anatomical changes as a result of the use of a liner.

[00158] In addition, compression moulds and implant templates designed and created according to the systems and methods described herein allow the formation of a PSI,PSAM, or PSMI from various materials, including but not limited to: i) acrylic materials (including, but not limited to medically available PMMA bone cement - both normal and antibiotic laced);

ii) metal materials (including, but not limited to titanium);

iii) thermoplastic materials (including, but not limited to polyetheretherketone (PEEK)); iv) regenerative medical scaffolds (for example, see Figures 6A to 6C);

v) additional precursor materials developed specifically for this process (for example, see Figures 7A to 7F);

vi) additional structural composite biomaterials developed specifically for this process; and

vii) modelling materials (including, but not limited to resins such as PU and silicone).

[00159] In some embodiments, PMMA (prefabricated) and PMMA (templated) methods pose a significant reduction in average infection risk.

[00160] In one embodiment, a system of compression moulds is created using the rapid templating process disclosed herein. Such a system of compression moulds allows the formation of custom regenerative implants. Embodiments disclosed herein create a bridge between traditional implantable solutions and tissue engineering methods to provide a prepackaged, custom formable, implantable product that provides initial load bearing characteristics whilst allowing tissue growth and calcification for long term bone regeneration. In one embodiment, a multi-layered scaffold is utilised. In one embodiment, a three layer approach is utilised. The three layers include:

• a structural mesh (for initial short-term stability - manufactured from

polycaprolactone (PCL));

• a tissue scaffold; and

• a gel layer.

[00161 ] The purpose of the scaffold and gel layer is to provide a positive avenue for tissue regeneration, whilst the mesh provides a structural stability during initial months of patient healing. In one embodiment the gel layer provides a mechanical support. In one embodiment the gel layer acts as an incompressible support for the construct which includes the mesh and the scaffold. One embodiment includes drying the gel on the surface of the scaffold to both open up the porosity and provide an entirely contained and packaged implantable solution (as a dry sample presents less risk in relation of pre-sterilisation and packaging); whilst boosting the capacity of the implant through the addition of factors (HA, antibiotics, growth factors) which can assist in stimulating regeneration and preventing infection.

[00162] An example of a regenerative medical scaffolds produced according to the systems and methods described herein is illustrated in Figures 6A to 6C. In particular, Figure 6A illustrates the superficial surface of a meniscal implant that has been compressed in a mould or implant, and with a liner removed. Figure 6B illustrates the posterior surface of the meniscal implant of Figure 6A, and Figure 6C illustrates the meniscal implant of Figure 6A following removal of excess scaffold.

[00163] Examples of precursor materials developed specifically for the creation of compression moulds and implant templates in accordance with the systems and methods described herein are illustrated in Figures 7A to 7F. Figure 7A illustrates generic specifications of a meniscal implant precursor with meniscus outline. Figure 7B illustrates a meniscal implant precursor model. Figure 7C illustrates a meniscal implant precursor scaffold. Figure 7D illustrates a scaffold precursor mould. Figure 7E is a top view of a scaffold precursor, and Figure 7F is a right side view of the scaffold precursor of Figure 7E. [00164] A system according to an embodiment of the invention includes a Product-Service- System (PSS) and associated tools and machinery. The PSS allows for the production of specific tools and machinery designed to provide assistance, semi-automation or full automation to the process of producing a medical device such as a PSI or PSAM.

[00165] Figure 8A illustrates an example manual tool, for an associated PSS, for forming a medical device according to an embodiment of the invention. In this embodiment, compression of the mould or template is manually performed.

[00166] Figure 8B illustrates an exemplary automated tool, for an associated PSS, for forming a medical device according to an embodiment of the invention. This embodiment allows compression of the mould or template to be automated.

[00167] The tools and machinery are designed to allow for the assisted / controlled formation of a PSI or PSAM (including a liner to separate the mould from the formed material, if necessary). This will account for at least the following: i) a manually guided formation press (for example, see Figure 8A);

ii) an automated formation press (for example, see Figure 8B);

iii) a customisable pressure application;

iv) a customisable pressure application timeframe; and/or

v) assistance (partial or complete) in removal of PSI or PSAM from a mould.

[00168] The tools and machinery are designed to also allow for the curing of any PSI or PSAM material as necessary. This will account for at least the following: i) curing through the use of heat, light or additional methods;

ii) ensuring uniform heating / curing through various sensors (including, but not limited to, infrared (IR) cameras, temperature sensors);

iii) provision of control systems to ensure the safety, efficacy and consistency of any manual or automated process; and/or

iv) allowing for the sterilisation of produced PSI or PSAM as required (including various potential methods of sterilisation).

[00169] The development of a PSS in regards to the production of PSI or PSAM includes at least the following: i) a system of direct purchase of machines and the development of an appropriate support network; and

ii) a system involving the lease of machines and the development of an appropriate support network.

[00170] The system described herein is modular and hierarchical in management of development risks.

Examples and application

[00171 ] In an exemplary embodiment of the invention, a spinal fusion device is manufactured using the rapid templating method disclosed herein. In particular, the spinal fusion device is manufactured using a pre-sterilised and pre-packaged generic spinal cage device that is then rendered to patients' specific anatomical features.

[00172] A system for a pre-sterilised and pre-packaged generic spinal cage device to be rendered according to patients' specific anatomical features allows for the assisted / controlled formation of a PSI (spinal fusion cage and/or total disc replacement) using methods as herein described. The design includes the following features: i) A compression focused rapid template.

ii) A zero-profile anchoring blade fixation system.

iii) Use of single phase thermoplastic polymer, a fiber-reinforced composite material with thermoplastics as the matrix phase, or other type of biomaterial that can be thermoformed without losing its original functional properties. This includes, but is not limited to Polycaprolactone (PCL) and Ultra High Molecular Weight Polyethylene (UHMWPE).

iv) Design of the implant (cage or disc replacement) through computer modelling software based on patient specific data (including, but not limited to CT scans). v) The allowance of geometry transformation of the implant through the rapid template mould, focusing on controlling axial deformation and press angle.

vi) A novel method of tube like composite structure formation.

[00173] Referring to Figure 9A there is illustrated implant design specifications of a generic spinal fusion cage. Figure 9B illustrates a 3D printed template of a spinal fusion cage 900. Figure 9C illustrates a silicone mould 901 for the fabrication of a spinal fusion cage. Figure 9D illustrates a generic spinal fusion cage 902 fabricated using the silicone mould 901 via hot pressing method.

[00174] Figure 10 illustrates a scanning electron microscope (SEM) image of a UHMWPE fibre-reinforced pre- impregnated composite tape 903 cross-section. In this embodiment, the composite tape 903 is to be processed via hot pressing to make a generic composite cage.

[00175] Figure 1 1 illustrates use of composite tape 903 where it is wrapped around the inner core of the silicone mould 901 .

[00176] Figure 12 illustrates the equipment setup for hot pressing where the silicone mould 901 of Figure 9C is positioned between two constraining metal plates 904.

[00177] Figure 13 is a diagram illustrating stresses exerted by the constraining components , silicone mould 901 and metal plates 904, on the wrapped composite tape 903 during hot pressing.

[00178] Figure 14 illustrates a generic composite cage with spiral indentation.

[00179] Figure 15A illustrates the silicone mould 901 and metal plates 904 of Figure 12 being compressed in an axial transformation vice 905 for axial geometry transformation of a spinal fusion cage. Figure 15B is a side view of various spinal fusion cages following the application of different axial strains. Figure 15C is a top view of the spinal fusion cages in Figure 15B.

[00180] Figure 16A illustrates the silicone mould 901 and metal plates 904 of Figure 12 being compressed in an angled transformation vice 906 for angled transformation of a spinal fusion cage. Figure 16B is a side view of various spinal fusion cages following the application of different axial strains to obtain varying angled transformations.

[00181 ] Figure 17A illustrates a twin blade fixation system 907 for a spinal fusion cage 908. The twin blade fixation system includes two single blades 909 connected at their proximal ends 910. In one exemplary embodiment, each blade is thin and flexible, with their surfaces being curved in shape, and their distal ends 91 1 tilted outwardly from one another. The distal end 91 1 of each blade 909 may be forked such that the two blades collectively form twin blades having four protruding portions.

[00182] It will be appreciated that the blades are of other formations in other embodiments of the invention. [00183] Figure 17B illustrates the twin blade fixation system 907 acting as a self-locking mechanism for a spinal fusion cage 908. During surgical insertion of a spinal fusion cage 908 in a patient, the spinal fusion cage 908 is inserted between adjacent vertebra and two sets of twin blade fixation systems 907 may be separately inserted into corresponding apertures 912 in the endplate 913 of the spinal fusion cage 908. One twin blade fixation system may be inserted thereby to curve upwardly, when viewed in a vertical direction, and the other twin blade fixation system may be inserted thereby to curve downwardly, when viewed in a vertical direction. The two sets of twin blade fixation systems 907 inserted in this manner form a diverging pattern. The unique shape and flexibility of the blades allow the blades to curve further along the diverging pattern as it goes through bony region. When the blades are in their final positions, the curvatures of the blades prevent back-out of the blades, which causes the blades to act as a self-locking mechanism.

[00184] An exemplary system 1800 according to an embodiment of the invention is illustrated in Figure 18. The system 1800 includes a printing device 1801 configured to create a template 1802 based on patient specific data. The system 1800 also includes a compression tool 1803 configured to compress the template 1802, which includes a material 1804 that has been added to a cavity 1805 of the template 1802, to form a medical device. In one embodiment, the medical device is a PSI. In other embodiments, the medical device is a PSAM.

[00185] In some embodiments, a liner is positioned between the cavity 1805 and the material 1804. In one embodiment, the liner forms a barrier between the cavity and the material. In one embodiment, the liner includes a texture that is transferred, at least in part, to the medical device during compression of the template. In one embodiment the liner includes a coating that is transferred to the medical device during compression of the template.

[00186] In some embodiments, the material is pre-sterilised. In other embodiments, the material is pre-packaged in a liner. The liner may protect an outer surface of the material in some embodiments. In further embodiments, the material is both pre-sterilised and prepackaged in a liner prior to being added to the template cavity. In some embodiments, the liner may be pre-sterilised. It will be appreciated that other variations and combinations of liners, pre- sterilisation and pre-packing may be applied and used in other embodiments.

[00187] It will be appreciated that the material is of various forms including a non- personalised generic implant, a non-personalised generic model and raw formation material. In one embodiment, it will be appreciated that the material is a compressible mouldable material. In other embodiments, it will be appreciated that the material is other than a compressible mouldable material. Furthermore, it will be appreciated that the material is not limited to these examples.

[00188] In one embodiment the printing device 1801 includes 3D printing technology, for example, desktop FDM 3D printing systems. However, it will be appreciated that other 3D printing technologies are used in other embodiments.

[00189] The system 1800 also includes a scanning device 1807 configured to obtain a patient scan. The system 1800 also includes imaging software configured to process the patient scan thereby to extract the patient specific data from the patient scan. The patient specific data extracted from the patient scan by the imaging software is stored in data repository 1808.

[00190] The printing device is communicatively coupled to the data repository 1808 and configured to access the patient specific data from the data repository 1808.

[00191 ] In one embodiment, the scanning device and imaging software are included in an integrated system. However, it will be appreciated that the imaging software is separate to the scanning device in other embodiments. In one embodiment the scanning device obtains the patient scan and transmits the patient scan to a computer, which includes imaging software, for processing.

[00192] It will be appreciated that the scanning device 1807 is any form of medical scanning device. In one embodiment, the scanning device 1807 includes a user interface 1809, a processor 1810 and a memory module 181 1 . Memory module 181 1 includes software instructions 1812, which are executable on processor 1810.

[00193] In one embodiment, the imaging software is computer imaging and CAD software, for example, CAD software marketed under the brand names Amira, Scan IP and Solidworks. However, it will be appreciated that other imaging software is used in other embodiments.

[00194] It will be appreciated that the compression tool may be referred to as a compression mould device. A compression moulding operation may be applied to the material, which is placed in the template, in the compression mould device, thereby compressing the material and transforming the material into a patient personalised medical device. In one embodiment, the compression tool or compression mould device is a vice. However, it will be appreciated that compression tools and compression mould devices other than vices may be used in other embodiments. [00195] Spinal fusion cages manufactured in accordance with the systems and methods described herein are advantageous over existing conventional generic fusion cages. For example, a fusion cage with larger footprint size and thinner wall thickness produced in accordance with an embodiment of the invention that matches patient imaging models may address complications that arise from poorly fitted implants with smaller footprint size and greater cage height.

[00196] PSI and PSAM manufactured in accordance with the systems and methods disclosed herein have various commercial applications including at least the following areas: i) skeletal reconstruction, for example:

(a) cranial, spinal and maxillofacial treatment; and

(b) pre-sterilised and pre-packaged generic spinal fusion cage devices to be rendered according to patients' specific anatomical features; ii) regenerative medicine, for example:

(a) development of customised bone and cartilage implants for regenerative treatment of numerous conditions; and

(b) development of customised tissue scaffolds and implants for regenerative treatment of numerous conditions and tissues including the meniscus and intervertebral disc;

iii) anatomical modelling for surgical planning;

iv) anatomical modelling for surgical practice;

v) anatomical modelling for surgical education;

vi) anatomical modelling for equipment calibration and reference;

vii) anatomical modelling in virtual environments;

viii) anatomical modelling in augmented-reality environments; and/or

ix) fabrication of tube like composite structures.

[00197] It will be appreciated that the above list of applications is provided as example applications and should not be considered as an exhaustive list of possible applications of the systems and methods described herein. It will be appreciated that there are other possible applications of the invention that have not been listed. [00198] The systems and methods described herein are used to produce a variety of medical devices such as anatomical implants and models including spinal fusion and spinal implants that may also contain gradients/heterogeneous elements.

[00199] Embodiments of the present invention provide custom implants and models that are produced both faster and with greater safety and efficacy than existing systems. In one preferred embodiment, custom implants and models produced according to the systems and methods described herein are manufactured within a hospital environment. However, it will be appreciated that custom implants and models produced according to the systems and methods described herein are manufactured in environments other than hospitals.

[00200] Embodiments of the present invention make use of Rapid Prototyping (RP) methods and Direct Digital Manufacturing (DDM) that alter the focus of existing systems and that tend to tailor patients to implants. In contrast to existing systems, the present invention tailors implants to patients by providing a system of custom implant and model production to assist in patient treatment. This paradigm shift has implications for the implant logistics cycle. That is, shifting from previous generic, high-volume production systems, to highly flexible, adaptable, fit-for- purpose, small-volume structure tailored systems for patient customisability.

[00201 ] As the logistics cycle of conventional implants is one of a generic, high-volume production system, manufacturing companies, including major multinationals, are actively seeking ways to reduce implant inventories and recycle unused parts. For example, some existing implant kits contain over 30 parts to account for different sizes and types of patients. Embodiments of the invention as herein disclosed provide systems and methods to enable suppliers to reduce their inventory, for example from kits containing over 30 parts down to 3 to 6 generic sizes and types which are then transformed to PSI by using the template method described herein.

[00202] The template method described herein links patient data with the manufacturing process. This opens opportunities in relation to implant formation and PSAM creation; changing the processes involved within the medical engineering profession. This extends beyond basic and currently accepted bioengineering materials (e.g. bone-cement for cranioplasty) and processes to encompass, for example, regenerative medicine bioactive scaffolds (e.g. for spinal disc regeneration), surgical mapping and planning technology, anatomically realistic models for patient education and surgical planning for brain tumour removal and forward integration into hospital environments. [00203] Advantages of embodiments of the present invention lie in the processing methods, implant design and biomaterials systems that result from the template method and system, and the envelope and packaging systems that allow terminally sterilised generic implants to be rapidly templated into patient-customised implants. The ability for terminally sterilised generic implants to be rapidly templated into PSI using the envelope and packaging systems means that PSI are produced more quickly than when conventional systems are used. Accordingly, waiting times for availability of PSI is significantly reduced. This in turn significantly reduces waiting times for patients and medical professionals. Embodiments of the invention are capable of templating a terminally sterilised blank or generic precursor (solid/scaffold/device) that is prepackaged and terminally sterilised so that the templated device can be rapidly formed in- surgery without any additional cleaning or sterilisation steps. Accordingly, embodiments of the invention provide methods and system for templating a ready to go packaged and terminally sterilised precursor, whether solid, resin or a mix. In some embodiments, temperature control techniques, and in particular heat transfer techniques, are used during the templating process for the acceleration and optimisation of in-surgery processes.

[00204] Other advantages of embodiments of the present invention include: lower cost, antibiotic elution, patient-matched for better fit, reduced likelihood of migration.

[00205] As implants produced in accordance with the systems and methods described herein are manufactured based on exact patient data, the implants will more closely mimic the natural body than generic conventional implants. Accordingly, PSI produced in accordance with embodiments of the invention will reduce the risk of implant migration, infection and morbidity.

[00206] It will be appreciated that the systems and methods for designing and manufacturing medical devices, such as anatomical implants and models, described in this disclosure produce PSI and PSAM which have numerous advantages over conventional implants and models. In particular, the present invention may be used to rapidly form a sterile implant from a generic precursor, via a method that accounts for anatomic, physiological and biomechanical requirements. The present invention has the following advantageous features:

• uses a novel textured envelope for isolating the implant from the templates without pleating and inconsistencies;

• terminally sterilised precursors (not just bone cement) that are isolated in the packaging can be formed within the packaging ;

• ensures accurate conformance by using moulding control elements with displacement constraint; • can induce textures/channels/holes that ensure tissue physiology is maintained and biomechanics are optimal;

• is applied to porous and non-porous shape-memory graft materials to induce anisotropy, gradients and hierarchical structure;

• can be used to transform existing implant designs (e.g. compressing a peek fusion cage to fit a very narrow spine segment);

• it can involve two or more steps in the templating process. That is, a template is moulded based on a template etc;

• the method is not simply concerned with defining a static mould, but also includes dynamically transforming via the template;

• the system includes novel combinations of shape-memory biomaterial systems that are fitted and enhanced en route;

• includes the use of bioactive elements (coatings) within the envelope that render the implant suitable for tissue integration; and

• includes the use of novel attachment methods that are compatible with the templating processes.

Definitions

[00207] Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilising terms such as "processing," "computing," "calculating," "determining", "analysing" or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities into other data similarly represented as physical quantities.

[00208] In a similar manner, the term "processor" may refer to any device or portion of a device that processes electronic data, e.g., from registers and/or memory to transform that electronic data into other electronic data that, e.g., may be stored in registers and/or memory. A "computer" or a "computing machine" or a "computing platform" may include one or more processors.

[00209] The methodologies described herein are, in one embodiment, performable by one or more processors that accept computer-readable (also called machine-readable) code containing a set of instructions that when executed by one or more of the processors carry out at least one of the methods described herein. Any processor capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken are included. Thus, one example is a typical processing system that includes one or more processors. Each processor may include one or more of a CPU, a graphics processing unit, and a programmable DSP unit. The processing system further may include a memory subsystem including main RAM and/or a static RAM, and/or ROM. A bus subsystem may be included for communicating between the components. The processing system further may be a distributed processing system with processors coupled by a network. If the processing system requires a display, such a display may be included, e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT) display. If manual data entry is required, the processing system also includes an input device such as one or more of an alphanumeric input unit such as a keyboard, a pointing control device such as a mouse, and so forth. The term memory unit as used herein, if clear from the context and unless explicitly stated otherwise, also encompasses a storage system such as a disk drive unit. The processing system in some configurations may include a sound output device, and a network interface device. The memory subsystem thus includes a computer-readable carrier medium that carries computer-readable code (e.g., software) including a set of instructions to cause performing, when executed by one or more processors, one of more of the methods described herein. Note that when the method includes several elements, e.g., several steps, no ordering of such elements is implied, unless specifically stated. The software may reside in the hard disk, or may also reside, completely or at least partially, within the RAM and/or within the processor during execution thereof by the computer system. Thus, the memory and the processor also constitute computer-readable carrier medium carrying computer-readable code.

[00210] Furthermore, a computer-readable carrier medium may form, or be included in a computer program product.

[0021 1 ] In alternative embodiments, the one or more processors operate as a standalone device or may be connected, e.g., networked to other processor(s), in a networked deployment, the one or more processors may operate in the capacity of a server or a user machine in server-user network environment, or as a peer machine in a peer-to-peer or distributed network environment. The one or more processors may form a personal computer (PC), a tablet PC, a set-top box (STB), a Personal Digital Assistant (PDA), a cellular telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine. [00212] Note that while diagrams only show a single processor and a single memory that carries the computer-readable code, those in the art will understand that many of the components described above are included, but not explicitly shown or described in order not to obscure the inventive aspect. For example, while only a single machine is illustrated, the term "machine" shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein.

[00213] Thus, one embodiment of each of the methods described herein is in the form of a computer-readable carrier medium carrying a set of instructions, e.g., a computer program that is for execution on one or more processors, e.g., one or more processors that are part of web server arrangement. Thus, as will be appreciated by those skilled in the art, embodiments of the present invention may be embodied as a method, an apparatus such as a special purpose apparatus, an apparatus such as a data processing system, or a computer-readable carrier medium, e.g., a computer program product. The computer-readable carrier medium carries computer readable code including a set of instructions that when executed on one or more processors cause the processor or processors to implement a method. Accordingly, aspects of the present invention may take the form of a method, an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of carrier medium (e.g., a computer program product on a computer-readable storage medium) carrying computer-readable program code embodied in the medium.

[00214] The software may further be transmitted or received over a network via a network interface device. While the carrier medium is shown in an exemplary embodiment to be a single medium, the term "carrier medium" should be taken to include a single medium or multiple media (e.g., a centralised or distributed database, and/or associated caches and servers) that store the one or more sets of instructions. The term "carrier medium" shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by one or more of the processors and that cause the one or more processors to perform any one or more of the methodologies of the present invention. A carrier medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, optical, magnetic disks, and magneto-optical disks. Volatile media includes dynamic memory, such as main memory. Transmission media includes coaxial cables, copper wire and fiber optics, including the wires that comprise a bus subsystem. Transmission media also may also take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications. For example, the term "carrier medium" shall accordingly be taken to included, but not be limited to, solid-state memories, a computer product embodied in optical and magnetic media; a medium bearing a propagated signal detectable by at least one processor of one or more processors and representing a set of instructions that, when executed, implement a method; and a transmission medium in a network bearing a propagated signal detectable by at least one processor of the one or more processors and representing the set of instructions.

[00215] It will be understood that the steps of methods discussed are performed in one embodiment by an appropriate processor (or processors) of a processing (i.e., computer) system executing instructions (computer-readable code) stored in storage. It will also be understood that the invention is not limited to any particular implementation or programming technique and that the invention may be implemented using any appropriate techniques for implementing the functionality described herein. The invention is not limited to any particular programming language or operating system.

[00216] It should be appreciated that in the above description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of this invention.

[00217] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[00218] Furthermore, some of the embodiments are described herein as a method or combination of elements of a method that can be implemented by a processor of a computer system or by other means of carrying out the function. Thus, a processor with the necessary instructions for carrying out such a method or element of a method forms a means for carrying out the method or element of a method. Furthermore, an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.

[00219] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[00220] Similarly, it is to be noticed that the term coupled, when used in the claims, should not be interpreted as being limited to direct connections only. The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus, the scope of the expression a device A coupled to a device B should not be limited to devices or systems wherein an output of device A is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. "Coupled" may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still cooperate or interact with each other.

[00221 ] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognise that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as falling within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

Claims

1 . A method for forming a patient-personalised medical device, the method including: i) selecting a non-personalised size variation of a medical device, wherein the non- personalised size variation of the medical device is selected based upon known size information for a patient, wherein at least a surface-proximal portion of the non-personalised size variation of the medical device is formed of a compressibly mouldable material, wherein the non-personalised size variation of the medical device is provided in a sterilized form having a liner for protecting an outer surface of the non-personalised size variation of the medical device;

iv) applying a compression moulding operation to the non-personalised size variation of the medical device in the compression mould device, thereby compressing the surface-proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient- personalised medical device.

2. A system for forming a patient-personalised medical device, the system including:

a compression moulding operation is applied to the non-personalised size variation of the medical device, which is placed in the patient-personalised moulding template, in the compression mould device, thereby compressing the surface- proximal portion of the non-personalised size variation of the medical device, thereby transforming the non-personalised size variation of the medical device into a patient- personalised medical device.

3. A method of manufacturing a patient-personalised medical device including:

4. A method according to claim 3 including:

using a scanning device to obtain a patient scan; and

processing the patient scan thereby to extract the set of patient specific measurement data points from the patient scan.

5. A method according to claim 4 wherein the patient scan is processed using computer imaging software.

6. A method according to any one of claims 3 to 5 wherein the liner forms a protective barrier between the template cavity and the material.

7. A method according to any one of claims 3 to 6 wherein the liner includes a texture that is transferred to the patient-personalised medical device during compression of the material in the template.

8. A method according to any one of claims 3 to 7 wherein the liner includes a coating that is transferred to the patient-personalised medical device during compression of the material in the template.

9. A method according to any one of claims 3 to 8 wherein the material and/or the liner are pre-sterilised.

10. A method according to any one of claims 3 to 9 wherein the material is pre-packaged in the liner.

1 1 . A method according to any one of claims 3 to 10 wherein the material is a non- personalised generic implant, a non-personalised generic model or raw formation material.

12. A method according to any one of claims 3 to 1 1 wherein the patient-personalised medical device is a patient specific implant.

13. A method according to any one of claims 3 to 1 1 wherein the patient-personalised medical device is a patient specific anatomical model.

14. A system for manufacturing a patient-personalised medical device including:

15. A system according to claim 14 including:

a scanning device configured to obtain a patient scan; and

imaging software configured to process the patient scan thereby to extract the set of patient specific measurement data points from the patient scan.

16. A system according to claim 14 or claim 15 wherein the liner forms a protective barrier between the template cavity and the material.

17. A system according to any one of claims 14 to 16 wherein the liner includes a texture that is transferred to the patient-personalised medical device during compression of the material in the template.

18. A system according to any one of claims 14 to 17 wherein the liner includes a coating that is transferred to the patient-personalised medical device during compression of the material in the template.

19. A system according to any one of claims 14 to 18 wherein the material and/or the liner are pre-sterilised.

20. A system according to any one of claims 14 to 19 wherein the material is prepackaged in the liner.

21 . A system according to any one of claims 14 to 20 wherein the material is a non- personalised generic implant, a non-personalised generic model or raw formation material.

22. A system according to any one of claims 14 to 21 wherein the patient-personalised medical device is a patient specific implant.

23. A system according to any one of claims 14 to 21 wherein the patient-personalised medical device is a patient specific anatomical model.