Definition

Patient-specific surgical planning software is a type of medical technology that allows surgeons to create detailed, customized surgical plans for individual patients. This software leverages patient-specific data, often from medical imaging such as Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans, to develop a precise 3D model of the patient's anatomy.

3D imaging such as Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) enables insights into patient-specific anatomies and can be used to plan surgeries. There are many types of patient-specific surgical planning software, from tools that allow cutting guides and implants to be designed, to augmented reality, measurement, and many other options for reproducing an anatomy, and carrying out virtual tests for planned procedures.

In areas such as orthopaedic surgery, for example, patient-specific image data provides the starting point for workflows to obtain 3D models, and test different implant designs to simulate best fit and potential complications, assisting in surgical planning, intraoperative decision-making, and postoperative review of outcomes. For software that is intended to have a diagnostic impact on a patient, such as for helping to decide on implant position, some form of medical device regulatory clearance is typically required.


What are the Benefits of Patient-Specific Surgical Planning Software?

The key benefits of patient-specific surgical planning software include the ability to explore a unique 3D anatomy without having to rely on standardized models, which helps to better understand the best approach for that individual. This method is particularly useful for complex individual cases, but can also be used with implant design software to virtually evaluate entire populations made up of patient image data without requiring physical testing. Virtual testing can therefore be a significant complement to traditional methods, by allowing for review and simulation of procedures without as much need for invasive, costly or time-intensive workflows.

In addition, patient-specific surgical planning can improve the efficiency of going from a diagnosis to a surgical plan by providing clinicians with more information and ways of visualizing and simulating potential outcomes. Confidence in decisions can thus be increased, while the ability to design and test personalized devices or implants, which can be further supported by 3D printing, means that more options can be explored for each patient.

Improved implant fit, assisted by simulation of movement and stresses, means that patients could potentially experience better long-term surgical outcomes. Similarly, for complex cases whereby visualizing abnormalities that need removing, 3D visualization, surgical simulation, and 3D printing, all help surgeons to measure and reduce risk ahead of a procedure, potentially saving time and reducing reliance on intraoperative imaging.

Patient-specific surgical planning software also has the benefit of improving communications with patients by visualizing their anatomy and talking them through a procedure, and for enhancing traditional surgical education through being able to test techniques with realistic anatomies. Depending on the particular surgical planning software, models and simulation outputs may be combined with other techniques in the operating room such as augmented reality, 3D printed cutting guides, and robotics, to help improve precision for better surgical outcomes, and reduce the risk of complications and the need for revision surgeries.


How Does Patient-Specific Surgical Planning Software Work?

Patient-specific surgical planning software can work in many ways, but generally they receive 3D imaging of a patient’s anatomy, which is then processed to segment (extract regions of interest), generate measurements and statistics, and subject to filters and other image-based tools. The result is a 3D model that realistically captures the patient’s anatomy to the level of detail required for the workflow; for example, it may be necessary to capture the finer features of the cardiovascular system.

At this point, the 3D patient model may be combined with a CAD-designed implant or other device, to virtually experiment in placement and interaction ahead of surgery. Other simulation methods may involve determining the best route to remove a tumour or other foreign body, or to explore adjustments to bone or tissue to correct for injury, or for cosmetic reasons. The applications of patient-specific surgical planning can therefore vary considerably.

Models can then be used in different contexts, for example to 3D print a physical anatomical structure with or without a device to better visualize patient details before a procedure, or as an input for augmented or extended reality to achieve similar aims. These methods might also be applied to help surgeons within the operating room, for example to overlay a 3D model over an anatomy, or to create a 3D printed surgical guide that can help with making incisions.


Patient-Specific Surgical Planning Software and Synopsys

Synopsys Simpleware Medical software is the FDA 510(k) cleared and CE marked product that can be used as part of patient-specific surgical planning workflows. For this application, Simpleware Medical generates 3D models from patient data that may be used to inform clinical decision-making, for example to better understand the patient’s anatomy, and for pre-surgical planning through visualization and measurements. Clinicians can improve future clinical procedures by using 3D image data to compare pre-surgical plans to post-surgical outcomes, while models can be used to improve clinical training and patient communication. In addition, virtual models can be exported as files for point of care 3D printing to further explore anatomies.

Going beyond Patient-Specific Surgical Planning Software

Synopsys Simpleware Medical is used within various clinical applications and workflows, from providing initial segmentation and measurements, to assisting in more comprehensive automated design and testing processes. Depending on the particular use of the software or the regulatory requirements of a country, this contribution may involve informing clinical decision-making, or assisting in medical research, for example into improving surgical planning knowledge without affecting patient care.

Putting Patient-Specific Surgical Planning Software into Practice

One application of Synopsys patient-specific surgical planning software involves 360 Med Care’s work in delivering innovative solutions for total knee replacement procedures. In this case, 360 Med Care develop patient-specific preoperative plans from 3D imaging data to help design guides for surgeons to familiarize themselves with prior to operations, therefore helping to increase confidence in choosing optimal cutting positions.

Knee Replacement

Knee segmentation using Simpleware software.

Steps:

  1. CT scans of the hip, legs, and ankle bones of patients are obtained.
  2. Images are imported to Simpleware software to segment regions of interest, and to position implants within the patient geometries.
  3. Scripts are used to assist in repeating segmentation and adding landmarking references to the geometries.
  4. 360 Med Care then design patient-specific guides for surgeons that are tailored to the individual bone geometry of the patient, to help make appropriate cuts for surgery.

Other examples of Synopsys patient-specific surgical planning software in use include contributing to a system by the Corin Group for planning patient-specific total hip arthroplasties. Automation of certain parts of this workflow have helped Corin deliver a pre-operative planning system that already been applied to over 20,000 hip procedures worldwide. In addition, research using Simpleware software is contributing to the development of in silico clinical trials for virtually testing high tibial knee osteotomy techniques, and for using 3D printed models to aid in oncological pre-surgical planning.

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