Periodic Reporting for period 2 - Optics-MISS (Optical Real-Time Anatomical Tracking- Minimally Invasive Spine Surgery)
Periodo di rendicontazione: 2021-03-01 al 2022-08-31
The problem – back pain and ‘freehand’ back surgery
Back pain is a highly prevalent condition that can have a tremendous social, financial, and psychological impact on a patient’s life. Low back pain is a worldwide problem, with an estimated 9.4% global incidence, creating more disability than any other condition in the world. The prevalence of low back pain increases with age, so it is understandable that there is an increasing rate of surgeries to treat back pain in accordance with an aging population demographic.
Degenerative disc disorders are among the most commonly diagnosed condition and are the leading causes of back and neck pain. According to the American Chiropractic Association, approximately 31 million people in the U.S. suffer from low back pain at any given time. It is estimated that over 90% of the 5 million spine surgeries are performed manually worldwide (also known as ”freehand”). When using the freehand technique, approximately 30% of the pedicle screws are misplaced, resulting in inferior clinical outcomes.
PathKeeper's Solution
PathKeeper's “Optical Real-Time Anatomical Tracking- Minimally Invasive Spine Surgery” (Optic-MISS) is planned to implement a Spine Navigation System using machine vision 3D cameras and AI-based algorithms to automatically match patients’ preoperative spine CT or MRI scans to images taken in the OR, a process called registration. Once the patient is registered, the surgeon can see the exact location of their surgical tools relative to the anatomy. Using the computer, the surgeon can see exactly where the target anatomy is, like using GPS to navigate while driving a car. Image-guided surgery allows surgeons to avoid damaging critical anatomy like the spinal cord and major blood vessels. Image guidance from machine vision results in safer surgery for patients. Navigation accuracy is crucial in spine surgeries, where a few millimeters can be the difference between a good outcome and major surgical complications.
PathKeeper developed the first Machine-Vision Image Guided Surgery system that allows spine surgeons to perform fast, cost-effective, radiation-free spinal navigation. Our Spine Navigation System provides real-time 3D images using machine-vision, camera-based technology. The system performs real-time tracking of the anatomy of the spine and the surgery tools, thus giving the surgeon accurate and timely feedback on the position S/he are in. The use of machine-vision image-guided surgery systems in the operating room (“OR”) instead of X-ray-based guidance is the only way to eliminate all radiation associated with navigation in the OR while facilitating a fast, efficient, and extremely accurate surgical experience.
Back pain is a highly prevalent condition that can have a tremendous social, financial, and psychological impact on a patient’s life. Low back pain is a worldwide problem, with an estimated 9.4% global incidence, creating more disability than any other condition in the world. The prevalence of low back pain increases with age, so it is understandable that there is an increasing rate of surgeries to treat back pain in accordance with an aging population demographic.
Degenerative disc disorders are among the most commonly diagnosed condition and are the leading causes of back and neck pain. According to the American Chiropractic Association, approximately 31 million people in the U.S. suffer from low back pain at any given time. It is estimated that over 90% of the 5 million spine surgeries are performed manually worldwide (also known as ”freehand”). When using the freehand technique, approximately 30% of the pedicle screws are misplaced, resulting in inferior clinical outcomes.
PathKeeper's Solution
PathKeeper's “Optical Real-Time Anatomical Tracking- Minimally Invasive Spine Surgery” (Optic-MISS) is planned to implement a Spine Navigation System using machine vision 3D cameras and AI-based algorithms to automatically match patients’ preoperative spine CT or MRI scans to images taken in the OR, a process called registration. Once the patient is registered, the surgeon can see the exact location of their surgical tools relative to the anatomy. Using the computer, the surgeon can see exactly where the target anatomy is, like using GPS to navigate while driving a car. Image-guided surgery allows surgeons to avoid damaging critical anatomy like the spinal cord and major blood vessels. Image guidance from machine vision results in safer surgery for patients. Navigation accuracy is crucial in spine surgeries, where a few millimeters can be the difference between a good outcome and major surgical complications.
PathKeeper developed the first Machine-Vision Image Guided Surgery system that allows spine surgeons to perform fast, cost-effective, radiation-free spinal navigation. Our Spine Navigation System provides real-time 3D images using machine-vision, camera-based technology. The system performs real-time tracking of the anatomy of the spine and the surgery tools, thus giving the surgeon accurate and timely feedback on the position S/he are in. The use of machine-vision image-guided surgery systems in the operating room (“OR”) instead of X-ray-based guidance is the only way to eliminate all radiation associated with navigation in the OR while facilitating a fast, efficient, and extremely accurate surgical experience.
The PathKeeper's system includes the following main innovative components:
• 3D camera - A high-resolution 3D camera that provides three-dimensional images of the operation area and specifically the exposed spine vertebrae. The 3D camera images are used by the software to register the location of each spine vertebra by matching exposed bone structure to pre-operative CT images. The continuous image acquisition by the camera enables also continuous non-radiative tracking of the location of each tracked vertebra.
• An articulated rigid metallic holding arm, connecting the camera to the operating table through a standard operating table rail, and sustaining it in place – roughly 1 meter over the operated anatomy – for the duration of the procedure.
• DRFs – Dynamic Reference Frames – reusable, steam-sterilized accessories serving as spatial markers for the OTI camera to track the spine and the surgical accessories intra-operatively.
• Standard navigation reflective spheres – single-use sterile reflective spheres that attach to the DRFs.
• TTU – a single-use sterile electronic Tool Tracking Unit (TTU) that provides additional highly accurate feedback on the position and the angle of the surgical tool it is attached to.
• M3D camera – a single-use Miniature 3D camera that is inserted into retractor tubes used in MISS. The M3D camera enables imaging of deep bone structures exposed thru the retractor tube opening. The software connects the M3D camera input to the 3D camera inputs to provide registration and tracking in MISS operations.
During the project the team worked on the following:
Market analysis:
• Revisiting the competitor's offering and value propositions.
• Interviewing and talking to key stakeholders: Surgeons, Hospital administrators, Distributors, and executives of large med-tech companies in the field from the EU, US, and APAC.
System design and development: Based on our plans and with details received from the market survey, the team has been designing the system, building prototypes, and testing them in the lab facility.
The main goals of the first year of the project were to reach the alpha version of the Optics-MISS environmental perception platform.
The software development team follows the plan for – Architecture design, Software design, and demonstration unit implementation.
As part of the first-year development, PathKeeper developed a demonstration unit, a system that can be easily moved
• 3D camera - A high-resolution 3D camera that provides three-dimensional images of the operation area and specifically the exposed spine vertebrae. The 3D camera images are used by the software to register the location of each spine vertebra by matching exposed bone structure to pre-operative CT images. The continuous image acquisition by the camera enables also continuous non-radiative tracking of the location of each tracked vertebra.
• An articulated rigid metallic holding arm, connecting the camera to the operating table through a standard operating table rail, and sustaining it in place – roughly 1 meter over the operated anatomy – for the duration of the procedure.
• DRFs – Dynamic Reference Frames – reusable, steam-sterilized accessories serving as spatial markers for the OTI camera to track the spine and the surgical accessories intra-operatively.
• Standard navigation reflective spheres – single-use sterile reflective spheres that attach to the DRFs.
• TTU – a single-use sterile electronic Tool Tracking Unit (TTU) that provides additional highly accurate feedback on the position and the angle of the surgical tool it is attached to.
• M3D camera – a single-use Miniature 3D camera that is inserted into retractor tubes used in MISS. The M3D camera enables imaging of deep bone structures exposed thru the retractor tube opening. The software connects the M3D camera input to the 3D camera inputs to provide registration and tracking in MISS operations.
During the project the team worked on the following:
Market analysis:
• Revisiting the competitor's offering and value propositions.
• Interviewing and talking to key stakeholders: Surgeons, Hospital administrators, Distributors, and executives of large med-tech companies in the field from the EU, US, and APAC.
System design and development: Based on our plans and with details received from the market survey, the team has been designing the system, building prototypes, and testing them in the lab facility.
The main goals of the first year of the project were to reach the alpha version of the Optics-MISS environmental perception platform.
The software development team follows the plan for – Architecture design, Software design, and demonstration unit implementation.
As part of the first-year development, PathKeeper developed a demonstration unit, a system that can be easily moved
Current Navigation systems in the market, create the anatomical map only once at the first stage of the operation and track the movement of only the surgery tool. PathKeeper solution, in open and MIS procedures, is the first and only system that tracks the patient anatomy in real-time throughout the surgery. Real-time tracking not only ensures higher precision and better safety, but it also enables new clinical applications which require higher accuracy (e.g. cervical spine procedures), and real-time anatomical correction (e.g. tumor removal). Minimally invasive spine surgery (MISS) is a type of surgery that uses smaller incisions than standard surgery. This often causes less harm to nearby muscles and other tissues. For MISS procedures, PathKeeper is developing a miniature 3D camera attached to the retractor tube, which uses the smaller opening to keep registration functioning. This enables real-time tracking of the anatomy even through the very small incisions of MISS, as well as real-time tracking of bone removal MIS procedures.
The real-time feedback allows the surgeon to be 5X more accurate in screw placement versus the best robotic navigation system today. Moreover, PathKeeper has reduced the entire workflow time to less than 15 seconds for patient registration out of the 30 minutes it takes competitor systems for the process of registration. PathKeeper's system leverages machine vision to segmentally register individual vertebrae in seconds, accounting for intersegmental motion and maintaining accuracy throughout the entire procedure. We are now able to show the operation of a full navigation system in MISS procedures –on phantoms and in cadaver testing. The impact will be safer back surgeries for the patients and staff.
The real-time feedback allows the surgeon to be 5X more accurate in screw placement versus the best robotic navigation system today. Moreover, PathKeeper has reduced the entire workflow time to less than 15 seconds for patient registration out of the 30 minutes it takes competitor systems for the process of registration. PathKeeper's system leverages machine vision to segmentally register individual vertebrae in seconds, accounting for intersegmental motion and maintaining accuracy throughout the entire procedure. We are now able to show the operation of a full navigation system in MISS procedures –on phantoms and in cadaver testing. The impact will be safer back surgeries for the patients and staff.