This application claims priority from AU2021902330 entitled Surgical training model filed on 29 Jul. 2021 the contents of which are hereby incorporated by reference in their entirety.
The present invention relates to a surgical training model which can be used by surgeons, educators, trainers and or students in the healthcare and human sciences fields for the purpose of surgical training, teaching and learning.
Surgical training models are fast becoming an adjunct to, and in some cases a replacement for cadavers and wet specimens in a wide range of demonstration and training environments.
Anatomy is considered the cornerstone of medicine. Cadavers and wet specimens have been an important gross anatomy teaching tool for many sciences and healthcare professions since the 15th Century. In addition to teaching anatomy, in recent years, cadavers have replaced live patients in surgical training. However, ethical issues, harmful bacteria and availability as well as improved technology have seen a decline in the use of cadaveric materials in training, teaching and demonstrating environments.
In 2012, the International Federation of Associations of Anatomists (IFAA) made a recommendation that only cadavers acquired through voluntary donation be used for teaching, training and research. Considering a large number of countries rely on unclaimed bodies for these purposes, as well as the high cost of acquiring and storing cadavers, the development of effective teaching and learning alternatives are an important emerging industry. Anatomy models and virtual dissection software have supplemented and, in some instances, replaced cadavers and wet specimens in gross anatomy teaching labs all over the world. One study has found that anatomy models are the most effective gross anatomy teaching tool compared with virtual dissection software and even cadaveric material pro-section as stand-alone learning aids.
With the advent and advancement of 3-D printing (3Dp) or Additive Manufacturing (AM) technology, 3D printed models are being used to teach, plan and practice surgical procedures as well as provide better patient education. Unlike other manufacturing techniques, AM can utilise Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) in the design process and/or CAD engineering programmes can be utilised to create anatomical shapes and test motional rotation and forces which results in detailed and anatomically correct replication of the anatomy, and in some cases, the production of functioning anatomical models. It has also led to the advent of tailored patient 3D models for surgical planning and rehearsal which decreases patient risk of iatrogenic injury, reduces surgical times and improves surgical outcomes for patients. In addition to tailored anatomical models, 3Dp enables manufacturers to produce custom pathologies within anatomy models including aneurysms, tumours and a variety of fracture patterns. These can be custom designed and manufactured to the client's specifications and needs.
A rapidly growing demand for surgical training models has emerged within the field of orthopaedic surgery, particularly for lower limb and upper limb fracture repair surgeries. Fracture patterns are diverse and occur on multiple sites. Depending on the location and severity of the fracture, unique surgical approaches are often required, thus the demand for anatomically correct models containing a variety of pathologies. Additionally, with the advancement of orthopaedic technologies, surgeons are frequently required to train on new technologies and products. The ability for surgeons to train on models up-skills surgeons without the need for them to learn and practice on live patients while still following the traditional tenet of surgical training, ‘see one, do one, teach one’.
In addition to 3D models producing better anatomy teaching outcomes, they can be easily obtained, transported, stored and reused. However, concerning the reuse of 3D models for teaching, this is not always the case for 3D models used for surgical planning or surgical teaching and practice. Once the models have been used, they are disposed of and need to be replaced. This is a very costly and wasteful exercise, particularly with larger anatomical models such as the lower limb. It also makes the routine use of large anatomically correct 3D models financially inaccessible to most healthcare and educational institutions. Not only does the expensive, disposable nature of the products limit the accessibility of invaluable, life-saving surgical practice aids, it also has an undesirable environmental impact.
Accordingly, there exists a need for improved surgical training model that reduces or at least ameliorates some of the problems of the prior art.
In a first aspect there is provided a surgical training model comprising a plurality of removable spacer cassettes that when arranged together simulate a limb or joint, each spacer cassette being removable and replaceable with an anatomy cassette that simulates anatomy and or pathology in the limb or joint.
The interchangeable parts of the surgical training model will be referred to herein as “cassettes”. Cassettes containing detailed anatomy and or pathologies will be referred to herein as “anatomy cassettes”, and the cassettes optionally without detailed anatomy and without pathologies will be referred to herein as “spacer cassettes”.
The limb that is simulated can be a lower limb. The limb that is simulated can be an upper limb. In an embodiment, the limb is a leg. In an embodiment, the limb is selected from one or more of a leg, a hip, an arm or a shoulder. The limb or joint can be an animal limb or joint. The limb or joint can be a human limb or joint. In the following description a human limb is referred to since the surgeons training on the model are typically human surgeons that will operate on other humans. However, there is no reason that the invention described herein could not be applicable to veterinary surgeons who operate on animals.
The surgical training model can be a lightweight 3D printed replica of the human lower limb consisting of multiple lightweight spacer cassettes on multiple positions on the leg. These cassettes can be removed and replaced with anatomy cassettes of various sizes containing various anatomies or pathologies. When the anatomy cassettes have been used and removed, the lightweight spacer cassettes can be returned.
A few simulator training models with replaceable parts are available to purchase, i.e. parts that can be replaced after use. These include breast examination, catheterisation, arthroscopy, episiotomy and vasectomy simulators. At the time of writing and to the best of our knowledge, no anatomy or training model on the market has been designing with interchangeable parts, i.e., parts containing different anatomies or pathologies on the same model. Existing training or simulator models are made and sold, but only cater for the practice of one procedure, i.e., each procedure simulation requires a separate model.
At the time of writing and to the best of our knowledge, no 3Dp anatomy model manufacturers produce models with either replaceable or interchangeable parts. Limb and joint models are typically large, heavy, and costly to produce. Once the model has been used, it is disposed of. At the time of writing and to the best of our knowledge, a solution to reduce the cost and waste of limb/joint surgical training models does not exist.
The present surgical training model may, in embodiments, increase the versatility of the 3D training model, may reduce costs and in embodiments minimises the environmental impact by decreasing the volume of disposable parts. The reduction in production costs and the versatility provided by the model may make the surgical model more affordable and thus more accessible to healthcare industries, healthcare providers, surgeons, educators and students.
The surgical training model can be light weight. By light weight it is meant that the model can be readily carried by one person. Because the surgical training model is lightweight, in embodiments, it is easier to transport and store, and less expensive to ship than a full surgical model would be. The surgical training model once fully assembled can weigh less than about 20, 26, 14 or 12 kg. Each cassette can weigh at most about 5 kg, 4 kg, 3 kg, 2 kg, 1 kg or 500 g. A larger surgical training model of e.g. the full lower leg will weigh more than a smaller surgical training model of e.g. the human arm.
The surgical model can be 3D printed using advanced 3D printing techniques. The surgical model can be made using a combination of manufacturing technologies. The model is not necessarily made wholly using 3D printing techniques. The model can be prepared in standard sizes. The standard sizes can be based on a typical limb or joint size using average dimensions sourced from data gathered from a human population. For example, the average human arm is 25 inches, with male arms tending to be longer and heavier than female arms due to increased bone size and larger muscles. Every human is different. With this in mind, there can be various standard sizes of the limbs and joints prepared such as small, medium, large, X-large. The small limb may have a length of about 15 inches, the medium limb may have a length of about 18 inches, the large limb may have a length of about 20 inches and so on. The standard sizes can be varied according to design preferences and customer requirements as would be understood by the person skilled in the technical area. Alternatively, the limb or joint can be 3D printed or otherwise manufactured as a tailored model based on data taken from a subject patient. A tailored anatomical model may be preferred where the model is intended to be used in training for a specific surgical procedure on the subject patient.
The cassettes can be self-supporting once connected to one another. The cassettes can be arranged adjacent one another to complete the limb or joint. Each cassette can be coloured and shaped to simulate the inside and or outside of a human body. The cassette pieces can appear as a puzzle that have to be fitted together in the correct order so as to provide the overall realistic appearance of the limb or joint once assembled.
The spacer cassettes can be arranged to provide a complete looking limb or joint with simulation of the outside shape of the limb. The anatomy cassette is more detailed and can replace a spacer to simulate that the outside of the limb part or joint has been taken away so that an operation can be performed on the material underneath. The anatomy cassettes may appear like the inside of the human body with muscle fibres and arteries/veins, ligaments and bone as if a slice had been taken out of the limb or joint and replicated. With this in mind, the spacer cassettes are not necessarily 3D printed since they need only provide the underlying limb or joint structure for supporting the anatomy cassette. The anatomy cassettes are preferably 3D printed because of the level of detail and realism required during any surgical training procedures undertaken on the model.
The cassettes can each be marked e.g. by numbers to assist in their assembly together with one another. The markings on the cassettes can be sequential so as to make it clear in which order the cassettes should be joined with one another. The markings can also assist the user to determine which way up an anatomy cassette should be inserted relative to the spacer cassettes provided.
Once the cassettes are located into position relative to one another, in embodiments, the limb or joint can be moved about any joint(s) present so as to simulate natural limb movement. The limb can be provided together with a joint. Each limb might have multiple joints e.g., lower limb has hip, knee and or ankle. Each spacer cassette can be securely attached to an adjacent cassette once in position. The removable attachment of spacer cassettes to one another can be by complementary attachment locations. The complementary attachment locations can be one or more of clips, magnets, adhesive or other. In an embodiment, each spacer cassette has an attachment location at each of its ends. The attachment location can be a strong, rigid plate on either end of the cassette that can comprise protrusions which can be inserted into a vacant position on a strong, rigid plate of an adjacent cassette. The protrusions and vacant positions can be dove-tail joints or similar engaging fasteners which holds each cassette in the limb or joint into position relative to one another. The rigid plate can be formed integrally with the cassette. The rigid plate can be formed separably to the cassette and joined with it afterwards to provide an integral piece.
Each spacer cassette is removable independently of the other cassettes. Each spacer cassette can be replaceable by an anatomy cassette. The anatomy cassettes can each represent a particular anatomy or a pathology. Replacement and interchangeable cassettes can be customised or tailored and made to order according to the needs of the client without the need for additional parts. The present surgical model, in embodiments, allows anatomies including bone structure, ligament structures, any unusual healing, shaping or congenital defects to be inserted into the model without the need for a new model to be produced. The present surgical model, in embodiments, allows pathologies including multiple fracture patterns to be inserted at multiple locations at the appropriate placement on the model without the need for an entirely new model to be produced for every fracture location or other pathology.
The anatomy cassette can simulate a pathology, disease, deformity, dislocation, fracture or injury of any kind including a lodged foreign body, or any alignment that can cause limb/joint pain. The pathologies can include any maladaptation of the limb or joint that requires a surgical procedure to correct. The pathology can be selected from one or more of a fracture, an aneurysm, a tumour, and a lodged foreign body. Before the advent of sterile surgical conditions and techniques, physicians stabilised fractures using external casts and splints. Now, internal fixation using implants such as plates, screws, and wires is common practice. Each fracture type and classification requires its own unique approach. Fracture locations in the lower limbs include distal femur, femoral head, femoral shaft, proximal tibia, distal tibia and tibial shaft, as well as different locations on the fibula, or a combination of fracture sites. Fracture locations in the upper limbs include humerus, radius and ulna fractures or a combination of fracture sites. Each aneurysm type and classification requires its own unique approach. Aneurysm locations can be at any location along the limb where arteries and veins travel.
Each tumour type and classification requires its own unique approach. Tumour locations can be at any location in the limb where there is tissue. Foreign bodies can become lodged in the limb for any reason. Foreign bodies include bullets and nails that sometimes become lodged in the limb by accident. In addition to pathologies, as noted above, various anatomies can be simulated be they commonplace or unusual.
Cassettes can be developed for revision surgery, where an original surgical operations needs to reworked due to complication or wear and tear. A number of the same cassette can be produced for more than one approach to the surgery to be tried and tested. Cassettes can also be developed to provide training for new tools or implants that are constantly evolving.
The anatomy cassette can fit into the location of the removed spacer cassette and be firmly locked into position. In an embodiment, the anatomy cassette can be attached to the spacer cassettes using the same attachment location means as described above. Optionally, a different attachment is provided so long as iti s engageable with the spacer cassette in some way that allows it to co-exist with the spacer cassette during use. Anatomy cassettes can be inserted at the joints of the limb (elbow, wrist, ankle, knee), at various positions along the shafts of the limb bones, at the proximal and distal ends of each of the limb bones or a combination of cassettes can be inserted at different locations at the same time. The anatomy cassette and remaining spacer cassettes do not move relative to one another once in position so that any surgical procedure performed on the simulated limb is not hampered by unrealistic movement of sections or parts. However, the anatomy cassette, once inserted, may allow the limp or joint that it forms to have a full range of normal motion representing human limb or joint motion.
In an embodiment a large anatomy cassette can be manufactured as one cassette piece to provide a larger surgical dissection region. The larger single anatomy cassette may replace two or more of the spacer cassettes in any combination.
Once the anatomy cassette has been used (i.e. dissected, operated upon, otherwise irreversibly destroyed), it can be removed and stored or disposed of. A spacer cassette with the same plates on either end can be inserted back in its place or it can be replaced by another anatomy cassette for another use. The limb is infinitely reusable as spacer cassettes and anatomy cassettes are switched into and out of position as required.
Also provided is a system providing training of a surgical procedure, the system comprising
In an embodiment, a surgical training procedure is related to an unusual knee structure. The details about this knee structure may originate from an actual patient, but the details for creation of the present surgical model are simulated using off the shelf software that can generate a limb of an average person. A plurality of spacer cassettes can be manufactured to provide a limb. The limb can be made up from a plurality of spacer cassettes but once they are all fitted together, it looks like one whole limb. The unusual knee anatomy can be 3D printed as a knee joint cassette. The spacer cassette of the limb that is at the location of the knee joint can be removed. The anatomy cassette 3D printed with the knee anomaly can be inserted into the limb. More than one limb that is identical to the one described in this paragraph can be prepared. This means that multiple surgical models could be provided for a surgical training day or an exam in the knowledge that each limb is the same as the other so no one person is disadvantaged or has an advantage.
In another embodiment, a surgical training procedure is related to a tumour in a shoulder joint. The details about this tumour may originate from an actual patient, but the details for creation of the present surgical model can be simulated using off the shelf software that can generate a shoulder joint of an average person. A plurality of spacer cassettes can be manufactured to provide a joint attached to the limb. The joint and limb can be made up from a plurality of spacer cassettes but once they are all fitted together, it looks like one whole shoulder and arm limb. The pathology can be 3D printed as a shoulder joint cassette. The spacer cassette of that is at the location of the shoulder joint can be removed. The anatomy cassette 3D printed with the shoulder anomaly can be inserted into the model. More than one model that is identical to the one described in this paragraph can be prepared. This means that multiple surgical models could be provided for a surgical training day or an exam in the knowledge that each limb is the same as the other so no one person is disadvantaged or has an advantage.
Furthermore, once each of the models described above has been used, the anatomy cassette of interest can be removed. The spacer cassette can be placed back into the model. The model can then be stored until it is required for use again. The next time the model is used, it may have a different anatomy cassette simulating a different anatomy or pathology.
Embodiments of the invention will now be described with reference to the accompanying drawings which are not drawn to scale and which are exemplary only and in which:
In
The surgical training model 10 of the embodiment of
In
Each of the anatomy cassettes 14 has a different location of pathology or anatomical issue of interest. The choice of location of the anatomy cassette can depend on where the pathology is on an actual patient or where a simulated anatomy or pathology is desirable. For example, a patient with a pathology or anatomical issue of interest relating to the femur could use the anatomy cassette 14 of
The health practitioner could work on the anatomy cassette 14 by e.g. undertaking a procedure. The practice on the cassette 14 might allow the practitioner to become familiar with the way in which to approach the pathology. Alternatively, or in addition, it might allow them to try various approaches to see what would work best. The practice on the cassette 14 might allow them to show another practitioner or train another practitioner on how to work on the particular pathology. When the anatomy cassette 14 has been used, it can be removed and the relevant spacer cassettes 12 can be returned. Alternatively, a new anatomy cassette 14 can be inserted ready for the next procedure.
In order to increase the realism of the model 10, the cassettes 12, 13, 14 and 15 of the model can be 3D printed or a combination of manufacturing technologies can be employed. Each cassette can be manufactured according to a required set of dimensions so that the overall limb once assembled is the required size. A small female limb might have cassettes that are relatively smaller in all dimensions when compared to a large male limb. The lower most cassette 13 can include additional features such as a foot (as shown in e.g.
In
In
As can be seen in e.g.
The attachment of the uppermost cassette 15 to the spacer cassette 12e is shown as two dove-tailed joints 16, 18. This is shown in close up in
Each spacer cassette can have a first end A and a second end B as shown in
It can be advantageous to have the arrangement shown in
Each spacer cassette 12 is removable independently of the other cassettes 12-15. Each spacer cassette 12 can be replaceable by an anatomy cassette 14. The spacer cassette 12 in e.g.
In one embodiment, the model 10 can comprises a base 20 that is used to support the plurality of cassettes 12-15. The base 20 can be a housing, platform, support or container into which the cassettes can be fitted. The base 20 can comprise a shelf onto which the cassettes can be arranged adjacent one another. In
In an embodiment, the upper part of a limb and lower part of a limb may be mounted e.g. via a ball joint to a metal, wood, plastic or composite base to allow free range of motion from a fixed position around the ball joints rotational axis. As can be seen in
While dovetails are shown in e.g.
The tongue part 26 of the attachment means can be provided on a plate 14a 14b which can be best seen in
It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.
In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.
Any promises made in the present description should be understood to relate to some embodiments of the invention and are not intended to be promises made about the invention as a whole. Where there are promises that are deemed to apply to all embodiments of the invention, the applicant/patentee reserves the right to later delete them from the description and does not rely on these promises for the acceptance or subsequent grant of a patent in any country.
Number | Date | Country | Kind |
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2021902330 | Jul 2021 | AU | national |
Filing Document | Filing Date | Country | Kind |
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PCT/AU2022/050803 | 7/29/2022 | WO |