Abstract: The present invention relates to novel tools and systems that provide a precision platform for professional health-related (PHR) communication where clinical relevance is standardized for the achievement of clinical precision. In particular, the present invention provides methods, tools, and systems using precision architecture control structure (PACS) comprising professional health-related (PHR) structured dialogs suitable for precise clinical diagnosis, in combination with encrypted transmission which is capable of HIPAA compliant communication of a healthcare information system with a credentialed user. The increased clinical precision of these tools, systems, and related methods affords greater efficiency in clinical treatment that is translated into increased safety in patient care, which extends far beyond simple communication of clinically relevant information.

Abstract: A system and method for intra-operatively measuring or verifying the placement of an implant within a bone in joint arthroplasty procedures are described herein. Pre-operative bone data of the patient is collected. A user plans the position of one or more implants relative to the pre-operative bone data. Intra-operatively, the patients bone is registered to the pre-operative bone data and to a computer-assist device. The bone is prepared and a physical implant is installed with the bone. A plurality of points are digitized on at least one of the physical implant or an apparatus associated with the physical implant. The computer-assist device calculates any errors between the planned position and orientation (POSE) of the implant relative to the actual POSE of the physical implant using the digitized points. The system may further notify a user of any errors and provide instructions to minimize the errors.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

Abstract: Described herein are systems and methods for creating a custom registration guide. In general, the methods may include receiving scan data of a patient's bone; creating instructions based on the scan data for creating a three-dimensional surface model of the patient's bone; and moving a plurality of moveable elements, coupled to the adjustable model, based on the instructions. The method may further include the steps of placing a malleable registration guide onto the adjustable model and shaping the registration guide to fit to the adjustable model. The method may further include the step of intraoperatively determining the location of a patient's bone using the custom registration guide. The step of determining the location of the patient's bone may include the steps of coupling the registration guide and fiducial markers to the patient's bone.

Abstract: Systems and methods for monitoring an operative site during a surgical procedure using a computer controlled surgical device. In general, the methods include the steps of processing one or more defined cutting paths having one or more cut regions; determining a correlation between the cut region and one or more critical regions to generate an alert, wherein the alert indicates a movable end-effector is within a defined proximity of the critical region; and requiring a user acknowledgment of the alert to allow processing of the cutting path to continue. Also described herein are systems and methods for minimizing user fatigue during a semi-computer controlled surgical procedure. In general, the methods includes the step of requiring a user generated acknowledgment in response to a computer generated alert, wherein the user acknowledgment is generated using a user controller, the user controller being minimally intrusive to the user experience.

Abstract: A system and method for intra-operatively measuring or verifying the placement of an implant within a bone in joint arthroplasty procedures are described herein. Pre-operative bone data of the patient is collected. A user plans the position of one or more implants relative to the pre-operative bone data. Intra-operatively, the patients bone is registered to the pre-operative bone data and to a computer-assist device. The bone is prepared and a physical implant is installed with the bone. A plurality of points are digitized on at least one of the physical implant or an apparatus associated with the physical implant. The computer-assist device calculates any errors between the planned position and orientation (POSE) of the implant relative to the actual POSE of the physical implant using the digitized points. The system may further notify a user of any errors and provide instructions to minimize the errors.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of ±1.0 mm and ±1.0°, or better in patient tissue.

Abstract: A system and method are provided that permits a mentor to remotely observe, train, or mentor an end-user of a medical device. The remote mentor is able to observe and take control, if necessary, of a medical device during a surgical procedure from a remote location using a network connection. New end-users, or end-users requiring assistance, may obtain feedback directly from the mentor in real-time. The remote mentor may remove power from the medical device at any time to provide assistance or recommendations to the end-user. The remote mentor can then re-activate the power, or allow the device to re-power, after assessing the situation.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of 1.0 mm and 1.0?, or better in patient tissue.

Abstract: A process for creating a curved contour on or within a bone is provided, where the process includes positioning a bone of a patient in a fixed position in a coordinate system, generating scan data of the bone, creating a three-dimensional surface model of the bone based on the scan data, generating a cutting program to modify a surface of the bone based on the three-dimensional surface model and a prosthesis having a bone interface shape that is complementary to the curved contour, and modifying the bone with one or more curved blades or a curved drill bit that is robotically driven and positioned with the cutting program to form the curved contour. A system for creating a curved congruent contour on or within a bone for mounting a prosthesis is also described.

Abstract: A method of creating an augmented implant for a subject's bone or joint is provided. A virtual bone or joint model of the subject's bone or joint is obtained, the bone or joint model inclusive of bone property data for the subject's bone or joint including at least topology, density, and microarchitecture data. At least one of a size, a type, a geometry and a position for a virtual implant model is determined with respect to the bone or joint model to replace the region for removal using a processor. A stability region in the bone or joint surrounding the position of the implant model is located based on the bone or joint property data. The implant model is augmented with one or more stability features to interact with the stability region to improve implant stability using said processor or another processor. The augmented implant is so created.

Abstract: A process and system for performing orthopedic surgery with the use of computer systems and robotic assistance to remove bone, bone cement, and a bone prosthesis, typically a bone prosthesis used in hip replacement surgery, knee replacement surgery, and the like. The process for replacing one or more bone prostheses using a robotic system includes receiving image data comprising an image of each bone, including at least one prosthesis implanted within each bone; creating three-dimensional models of the prosthesis, and the bone; creating a plan for positioning new prostheses within the bone; determining the location and amount of bone and any non-bone material to be removed for the new prostheses; and removing the bone prosthesis from the bone. The inventive process may be used for the replacement of hip joints, shoulder joints, ankle joints, wrist joints, finger joints, toe joints, or other joints.

Abstract: The present invention relates to novel tools and systems that provide a precision platform for professional health-related (PHR) communication where clinical relevance is standardized for the achievement of clinical precision. In particular, the present invention provides methods, tools, and systems using precision architecture control structure (PACS) comprising professional health-related (PHR) structured dialogs suitable for precise clinical diagnosis, in combination with encrypted transmission which is capable of HIPAA compliant communication of a healthcare information system with a credentialed user. The increased clinical precision of these tools, systems, and related methods affords greater efficiency in clinical treatment that is translated into increased safety in patient care, which extends far beyond simple communication of clinically relevant information.

Abstract: Described herein are systems and methods for creating a custom registration guide. In general, the methods may include receiving scan data of a patient's bone; creating instructions based on the scan data for creating a three-dimensional surface model of the patient's bone; and moving a plurality of moveable elements, coupled to the adjustable model, based on the instructions. The method may further include the steps of placing a malleable registration guide onto the adjustable model and shaping the registration guide to fit to the adjustable model. The method may further include the step of intraoperatively determining the location of a patient's bone using the custom registration guide. The step of determining the location of the patient's bone may include the steps of coupling the registration guide and fiducial markers to the patient's bone.

Abstract: Systems and methods for monitoring an operative site during a surgical procedure using a computer controlled surgical device. In general, the methods include the steps of processing one or more defined cutting paths having one or more cut regions; determining a correlation between the cut region and one or more critical regions to generate an alert, wherein the alert indicates a movable end-effector is within a defined proximity of the critical region; and requiring a user acknowledgment of the alert to allow processing of the cutting path to continue. Also described herein are systems and methods for minimizing user fatigue during a semi-computer controlled surgical procedure. In general, the methods includes the step of requiring a user generated acknowledgment in response to a computer generated alert, wherein the user acknowledgment is generated using a user controller, the user controller being minimally intrusive to the user experience.

Abstract: Described herein are systems and methods for creating a custom registration guide. In general, the methods may include receiving scan data of a patient's bone; creating instructions based on the scan data for creating a three-dimensional surface model of the patient's bone; and moving a plurality of moveable elements, coupled to the adjustable model, based on the instructions. The method may further include the steps of placing a malleable registration guide onto the adjustable model and shaping the registration guide to fit to the adjustable model. The method may further include the step of intraoperatively determining the location of a patient's bone using the custom registration guide. The step of determining the location of the patient's bone may include the steps of coupling the registration guide and fiducial markers to the patient's bone.

Abstract: Systems and methods for monitoring an operative site during a surgical procedure using a computer controlled surgical device. In general the methods include the steps of processing one or more defined cutting paths having one or more cut regions; determining a correlation between the cut region and one or more critical regions to generate an alert, wherein the alert indicates a movable end-effector is within a defined proximity of the critical region; and requiring a user acknowledgment of the alert to allow processing of the cutting path to continue. Also described herein are systems and methods for minimizing user fatigue during a semi-computer controlled surgical procedure. In general the methods includes the step of requiring a user generated acknowledgment in response to a computer generated alert, wherein the user acknowledgment is generated using a user controller, the user controller being minimally intrusive to the user experience.

Abstract: A process and system for performing orthopedic surgery to create a series of channels with a subject's bone to allow a reduced pressure system to be applied directly to the bone-implant interface to enhance bone healing is provided. The process for to promote healing of a bone of a subject includes creating a three-dimensional model of the bone; preoperatively planning a location of an implant relative to the model; creating a plan for the location of precision channels that reach the bone-implant interface based on the model and the implant; resurfacing the bone to fit the implant into or onto the bone based on the preoperative plan; and milling the precision channels into the bone in the location to promote healing of the bone and/or bone implant interface; and applying a pressure reduction system at the bone-implant interface to promote bone healing.

Abstract: An articulating drill system is provided that includes a hand-held portion and a drill portion. At least two actuators are provided for controlling at least two axes of the drill portion. A navigation system is provided to control the at least two actuators. In some embodiments, a tool is provided with the drill portion and adapted to interact with patient tissue. The drill portion can be modified to include at least two rigid objects in communication with the actuators and attached to the drill portion. The system can be used to make any linear cut within a deviation of 1.0 mm and 1.0?, or better in patient tissue.