This short PowerPoint presentation explores patient-specific implants (PSIs), a game-changing innovation in healthcare. PSIs are personalized medical devices tailored to individual patients, offering precision and improved outcomes in surgeries. This presentation will delve into the technology, benefits, applications, and future prospects of PSIs, showcasing their potential to transform the way we approach medical treatments and improve patients' lives.
2. Introduction
• Patient-specific implants (PSIs) are medical devices that are designed and
produced to match the unique anatomy of an individual patient.
• These implants are typically used in surgical procedures where off-the-shelf
devices may not provide the best fit or function.
3. How PSI are different from Conventional Implants?
1. Personalization
2. Surgical fit and planning
3. Design and manufacturing process
4. Materials
5. Cost and availability
6. Lead time
4. Application of PSI in oral and maxillofacial surgery
1. Reconstruction
2. Maxillofacial prosthetics
3. Dental implants
4. Orthognathic surgery
5. Cranioplasty
6. Temporomandibular joint surgery
5. Steps involved in fabrication of PSI
1.Patient
assessment
and imaging
Image
processing
Virtual
planning
Implant
design
Manufacturing
Quality
control
Sterilization
11. Disadvantages
• Cost
• Time
• Need for advanced imaging
• Regulatory and reimbursement challenges
• Limitation in complex anatomy
• Risk of design or manufacturing errors
• Limited room for adjustment
12. Future direction
• Use of bioactive and smart materials
• Intra-operative 3D printing
• Regenerative medicine and tissue
engineering
• Use of artificial intelligence in precise
designing
13. References
• Patient-specific implants in maxillofacial surgery: Role, techniques and future directions by S. S.
Kheur, et al., in the International Journal of Oral and Maxillofacial Surgery, 2020.
• Applications of patient specific 3D printed models in oral and maxillofacial surgery by G. J. Hatch
and A. A. Shaikh in the Journal of Oral and Maxillofacial Surgery, 2020.
• The use of patient-specific implants in oral and maxillofacial surgery by T. J. J. Maal and A. G.
Becking, in Oral and Maxillofacial Surgery Clinics of North America, 2016.
• Designing patient-specific 3D printed devices for rare craniofacial disorders by D. Wang, et al., in
Journal of Oral and Maxillofacial Surgery, 2018.
Hinweis der Redaktion
Personalization: PSIs are designed and manufactured specifically to fit an individual patient's anatomy, using detailed imaging data such as CT or MRI scans. In contrast, stock implants are mass-produced in a range of standard sizes and shapes.
Surgical Fit and Planning: Because PSIs are tailored to the patient's anatomy, they often provide a better fit during surgery and require fewer intraoperative adjustments. This can lead to more accurate placement and potentially better surgical outcomes. Stock implants may require more adjustments during surgery to achieve an adequate fit.
Design and Manufacturing Process: The process of designing and manufacturing PSIs involves advanced technologies such as 3D imaging, computer-aided design (CAD) software, and additive manufacturing (3D printing). Stock implants are typically made using traditional manufacturing techniques.
Materials: Both PSIs and stock implants can be made from a variety of materials, including metals, ceramics, and polymers. However, due to the manufacturing techniques used for PSIs, there may be more flexibility in material choice.
Cost and Availability: Stock implants are typically less expensive and more readily available due to mass production. PSIs, on the other hand, can be more costly and require more time to produce due to the custom design and manufacturing process. However, the potential for improved fit and reduced operation time can offset these costs.
Lead Time: Because PSIs are custom-made, they require a lead time between when the imaging is done and when the implant is ready for surgery. Conventional implants are typically available immediately.
Reconstruction: Patient-specific implants are extensively used for the reconstruction of hard tissue defects resulting from trauma, tumor resection, or congenital defects. They are particularly useful in complex or large-scale reconstructions where off-the-shelf implants may not provide an optimal fit.
Maxillofacial Prosthetics: Implants can be designed to replace missing maxillofacial structures, such as the eye, ear, or nose. These prosthetics can be designed to match the patient's unique anatomy for a more natural appearance.
Dental Implants: In cases of tooth loss, patient-specific dental implants can be designed to fit precisely into the patient's jawbone and match the shape and size of the missing tooth.
Orthognathic Surgery: In surgeries aimed at correcting conditions that affect the jaw and face, patient-specific implants can be used to move the jawbones to the correct position and hold them in place.
Cranioplasty: For patients who have undergone cranial surgery or suffered cranial trauma, patient-specific implants can be designed to replace missing or damaged parts of the skull.
Temporomandibular Joint (TMJ) Surgery: If a patient requires TMJ replacement, a patient-specific implant can be designed to replace the joint and restore its function.
Patient Assessment and Imaging: The process starts with a thorough assessment of the patient's condition. This typically involves imaging techniques such as computed tomography (CT) or cone-beam computed tomography (CBCT) to provide detailed 3D images of the patient's anatomy.
Image Processing: The imaging data is processed and analyzed using specialized software. The aim is to create a precise 3D model of the affected area that can serve as the basis for the implant design.
Virtual Planning: Surgeons use the 3D model to create a virtual treatment plan. This involves determining the optimal placement and specifications for the implant. The plan can also include the design of surgical guides to assist in the accurate placement of the implant during surgery.
Implant Design: Using the treatment plan as a guide, the implant is designed to fit the patient's specific anatomy. This involves selecting the appropriate shape, size, and material for the implant to ensure the best possible fit and function.
Manufacturing: Once the implant design is finalized, it is manufactured using additive manufacturing techniques such as electron beam melting (EBM). This involves building the implant layer by layer based on the digital 3D model.
Quality Control: The finished implant undergoes quality control checks to ensure it meets all necessary specifications and standards. This may include checks for dimensional accuracy, material properties, and surface finish.
Sterilization: Prior to surgery, the implant is sterilized to ensure it is safe to use. This typically involves cleaning the implant and then using a method such as autoclaving to kill any potential contaminants.
High Resolution: The CT scan must be of high resolution to capture all necessary details of the patient's anatomy. This is typically achieved with slice thicknesses of less than 1mm, which allows for detailed 3D reconstruction.
Contrast Resolution: CT scans must provide high contrast resolution to differentiate between different types of tissues. This is particularly important when designing implants to interface with different tissue types.
Standardized Acquisition Protocols: to ensure consistency in image quality and accuracy. This includes patient positioning, scan parameters (e.g., voltage, current), and the use of contrast agents if necessary.
Image Acquisition: The first step in the process is the acquisition of medical images from the patient. This is typically done using high-resolution imaging modalities like computed tomography (CT) or magnetic resonance imaging (MRI). These images provide detailed information about the patient's unique anatomy.
Conversion to DICOM: The medical images are usually stored and transmitted in the DICOM (Digital Imaging and Communications in Medicine) format, which preserves the detailed data contained in the images.
Segmentation: This is the process of identifying and isolating the areas of interest within the images. For instance, if a PSI is being made for a bone defect, the software would be used to identify and isolate the images of the bone structures.
3D Reconstruction: The 2D DICOM images are then used to create a 3D model of the patient's anatomy. This 3D model serves as the basis for the design of the PSI.
Design of PSI: Using specialized software, the 3D model is used to design the PSI. The software allows for the manipulation of the model to create an implant that fits perfectly within the patient's anatomy.
Verification and Validation: The design of the PSI is then verified and validated, often with input from the surgeon. Any necessary adjustments to the design are made at this stage.
Export for Manufacturing: Once the design has been finalized and approved, it is exported from the software in a format suitable for the chosen manufacturing process, often 3D printing. The exported file guides the manufacturing equipment to create the PSI.
The specific image processing techniques and software used can vary depending on the type of PSI being manufactured, the imaging modality used, and other factors. The goal, however, is always to create a PSI that is perfectly tailored to the patient's unique anatomy.
Additive Manufacturing: Also known as 3D printing, this is a common method for creating patient-specific implants. It involves building up the implant layer by layer from a digital 3D model. Various 3D printing techniques can be used, including Fused Deposition Modeling (FDM), Stereolithography (SLA), Digital Light Processing (DLP), Selective Laser Sintering (SLS), Selective Laser Melting (SLM), and Electron Beam Melting (EBM).
Subtractive Manufacturing: This method starts with a block of material that is then carved or milled down to create the implant. While it can be used to create patient-specific implants, it's generally less efficient than additive manufacturing for this purpose.
Injection Molding: This process involves injecting molten material into a mold of the implant shape. While this process is typically used for mass-produced items, it can be used for patient-specific implants if a unique mold is created for each patient.
Titanium and Titanium Alloys: Titanium is a common material for PSIs due to its excellent biocompatibility, strength, and resistance to corrosion. It's often used for dental implants, bone plates, and other load-bearing implants.
Stainless Steel: Stainless steel is used in some implants due to its strength and durability. However, it's less commonly used for PSIs due to concerns about its biocompatibility compared to other materials like titanium.
PEEK (Polyether Ether Ketone): PEEK is a type of thermoplastic that's biocompatible and has mechanical properties similar to bone. It's often used for cranial and maxillofacial implants, and its radiolucent properties make it an attractive choice for implants that need to be evaluated using radiographic imaging postoperatively.
Ceramics: Biocompatible ceramics, such as zirconia and hydroxyapatite, are sometimes used for dental and facial implants. They can be colored to match the patient's natural teeth or bone, providing better aesthetic outcomes.
Polymeric Materials: Various biocompatible polymers, such as polyethylene or polypropylene, may be used for certain types of implants. These materials are lightweight and can be molded into complex shapes.
Composites: Combinations of different materials can be used to create composite implants that combine the desirable properties of each component. For example, a composite of PEEK and carbon fiber can provide increased strength.
Improved Fit: PSIs are designed to fit the unique anatomy of the individual patient, which can provide a superior fit compared to standard implants. This can lead to better integration with the patient's own tissues and potentially improved function of the implant.
Reduced Operation Time: With traditional implants, significant time during surgery may be spent making adjustments to achieve the best fit. Because PSIs are designed to fit precisely, they can potentially reduce operation time.
Enhanced Aesthetic Outcomes: Particularly in surgeries where aesthetics are important (such as craniofacial surgeries), PSIs can provide better aesthetic results because they are designed to replicate the patient's own anatomy.
Decreased Complications: The precise fit of PSIs may reduce the likelihood of complications associated with poor implant fit, such as loosening or displacement of the implant, and the potential for additional surgeries.
Improved Patient Satisfaction: The improved fit, function, and aesthetics of PSIs can lead to increased patient satisfaction.
Better Functional Outcomes: PSIs, due to their precise fit and customization, may lead to better functional outcomes, especially in cases of complex anatomical reconstructions.
Increased Surgeon Confidence: Surgeons may feel more confident going into surgery knowing that the implant has been specifically designed for their patient, potentially improving surgical outcomes.
Cost: PSIs can be significantly more expensive than off-the-shelf implants due to the individualized design and manufacturing process.
Time: The process of designing and manufacturing a PSI is time-consuming. It requires acquiring precise patient imaging, creating a digital model, designing the implant, and then fabricating it, often using 3D printing or other advanced manufacturing techniques.
Need for Advanced Imaging: PSIs require high-quality, detailed imaging (such as CT or MRI scans) to accurately model the patient's anatomy. This may not be readily available in all healthcare settings.
Regulatory and Reimbursement Challenges: PSIs can face regulatory challenges because they don't fit the standard models for device approval. Similarly, insurance reimbursement for PSIs may not be straightforward because they're not standard devices.
Limitations of Current Technology: While 3D printing and other technologies used to create PSIs are continually improving, there can still be issues with achieving the necessary precision, particularly for complex anatomical structures.
Risk of Design or Manufacturing Errors: While rare, there is a risk of errors in the design or manufacturing process which could result in an implant that does not fit correctly.
Bioactive and Smart Materials: The development of new materials that can interact with the body in beneficial ways, such as materials that promote tissue growth or that can deliver drugs locally, will open up new possibilities for PSIs.
Intraoperative 3D Printing: With advancements in 3D printing technology, it may be possible to print PSIs directly in the operating room based on real-time imaging data. This could allow for even greater customization and potentially reduce the time between imaging and surgery.
Regenerative Medicine and Tissue Engineering: In the future, it may be possible to use PSIs as scaffolds for growing patient's own cells, leading to implants that are even more biocompatible and that can grow and change with the patient.