Systems and methods for patient-based computer assisted surgical procedures
Inventors
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Assignees
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Smith+NephewSmith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.
Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.
Publication Number
US-12268452-B2
Publication Date
2025-04-08
Expiration Date
2031-04-14
Abstract
Surgical systems and methods are disclosed for creating a 3D model of a patient's affected area using an imaging device, using the model to determine an implant orientation and position, creating patient-matched instrumentation, placing the patient-matched instrumentation on the patient's anatomy, registering a computer-assisted surgical tool, and acquiring registration information. The methods and systems also include associating the surgical tool with a computer to perform a computer assisted surgery. Also disclosed are embodiments of patient-matched instrumentation to acquire registration information.
Core Innovation
The invention provides systems and methods for computer-assisted surgical procedures that use a patient-specific approach, beginning with imaging a patient's affected area and creating a 3D model of the bone or joint. This model is used to determine an optimal implant, its positioning, and to plan surgical modifications virtually. Patient-matched instrumentation, such as alignment or registration blocks, is created to precisely fit the patient’s anatomy and incorporate features that allow reliable registration during surgery.
The core issue addressed is the inefficiency, inaccuracy, and potential for error in traditional registration processes for orthopedic surgery. These conventional methods are tedious and time-consuming, often requiring assistants and leading to possible misalignment if patient or reference arrays are moved. Furthermore, matching preoperative models to actual patient bones can be difficult, resulting in sub-optimal fit or inaccurate surgical execution.
To solve this, the disclosed systems employ registration blocks or guides with surfaces contoured to the patient’s anatomy and registration sites derived from the virtual surgical plan. These registration sites correspond to known marker positions in the patient’s virtual model, enabling precise intraoperative alignment and tool tracking using computer software and tracking arrays. The process can store and utilize surgical plans and registration data, and enables re-registration if needed, thus ensuring accurate, repeatable, and efficient computer-assisted surgeries.
Claims Coverage
There is one independent claim outlining the core inventive features of the system.
Patient-matched components with single spatial orientation for bone coupling
The system comprises a first component and a second component that can be selectively coupled in a predetermined spatial orientation, with at least one component having a patient-matched surface configured to couple to the bone in a single spatial orientation. This ensures precise and repeatable alignment on the patient's bone.
Tracking markers and selective retention/removal of components
At least one of the first or second components includes one or more tracking markers joined thereto. The system is configured such that one component can be removed from the bone while the other is retained, maintaining the predetermined spatial relationship necessary for accurate registration.
Tracking device and processor with registration instructions
The system includes a tracking device with sensors to detect the location of the tracking markers, a processor, and a non-transitory computer-readable medium storing instructions. These instructions, when executed, receive marker location data and register the position of the bone based on the locations of the tracking markers, the single spatial orientation, and the predetermined spatial orientation of the components.
The inventive features provide a system enabling precise, single-orientation coupling of patient-matched components to bone, with tracking markers and registration, supported by computer-implemented instructions for accurate and repeatable surgical navigation.
Stated Advantages
Provides a more accurate and repeatable registration process for a patient’s bone during computer-assisted surgery.
Speeds up the registration process compared to manual methods.
Enables precise and consistent alignment of virtual surgical plans with actual patient anatomy using patient-matched blocks.
Eliminates tedious, time-consuming, and error-prone manual registration techniques.
Facilitates easier re-registration if the registration device must be removed and remounted during surgery.
Improves the accuracy of implant placement and bone modification according to pre-surgical planning.
Allows the surgical block to fit in only one spatial orientation, ensuring reliable anatomical registration.
Documented Applications
Computer-assisted orthopedic surgeries such as knee, hip, shoulder, ankle, and elbow joint replacements or reconstructions.
Arthroplasty or reconstruction of hip, foot, arm, elbow, shoulder, neck, spine, cranio-maxillofacial (CMF) regions, and extremities.
Use with automated robotic surgery systems for registration and controlled surgical bone modification.
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