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Publication Number
US-12274631-B2
Publication Date
2025-04-15
Expiration Date
Abstract
A system and method may be used to evaluate soft tissue. A knee arthroplasty soft tissue evaluation may use an adjustable spacer, such as varying sized physical spacers or an inflatable bladder, along with a sensor to measure force, pressure, gap distance, or the like during a range of motion test. A method may include maintaining an equal pressure or gap distance for a medial component and a lateral component of an adjustable spacer during a range of motion test. Information, including, for example a maximum or minimum gap distance or pressure may be determined during the range of motion test. The determined information may be output for display or used to update a surgical plan.
Core Innovation
The invention relates to robotic knee arthroplasty soft-tissue balancing using an adjustable spacer having one or more integral pumps. The method generates a preoperative plan for a knee arthroplasty, prepares a first bone to produce a resected surface, and inserts the adjustable spacer between the resected surface and a surface of a second bone.
A first adjustable component of the adjustable spacer is inflated using the one or more integral pumps to separate the first bone and the second bone on a medial side, and a second adjustable component is inflated using the one or more integral pumps to separate the first bone and the second bone on a lateral side. The second adjustable component is independently adjustable from the first adjustable component, and the method maintains either an equal gap distance or an equal pressure between the medial side and the lateral side by increasing or decreasing pressure or by increasing or decreasing gap distance with the integral pumps.
Throughout a range of motion test with the adjustable spacer in place, the method measures force on the adjustable spacer using a force sensor device and tracks a position of bones using an optical tracking system operatively coupled to the surgical system. The method determines a maximum force or a maximum gap distance during the range of motion test and outputs the maximum value for display on a user interface of a computer system, with the maxima used to update a preoperative plan including implant sizing and implant heights.
Claims Coverage
Two independent method claims are identified: clm-00001 and clm-00011. Each claim centers on generating a preoperative plan, using an adjustable spacer with one or more integral pumps for medial and lateral balance during a range of motion test, measuring with sensors, determining a maximum value, and outputting the maximum for display on a user interface.
Preoperative plan for knee arthroplasty with adjustable spacer and integral pumps
Generating a preoperative plan for a knee arthroplasty; providing a surgical system including a computer system and an adjustable spacer having one or more integral pumps.
Medial and lateral separation using independently adjustable spacer components
Inflating a first adjustable component using the one or more integral pumps to separate the first bone and the second bone on a medial side; inflating a second adjustable component using the one or more integral pumps to separate the first bone and the second bone on a lateral side, the second adjustable component independently adjustable from the first adjustable component.
Maintaining equal gap distance or equal pressure during range-of-motion test
Maintaining an equal gap distance between a medial gap and a lateral gap by increasing or decreasing pressure in the first or second adjustable component with the one or more integral pumps; measuring force throughout a range of motion test with the adjustable spacer in place and the equal gap distance maintained.
Force measurement and determination of maximum force with optical tracking
Measuring force throughout the range of motion test using a force sensor device; tracking a position of bones utilizing an optical tracking system throughout the range of motion test; determining a maximum force measured by the force sensor device during the range of motion test; outputting the maximum force for display on a user interface.
Equal pressure maintained by adjusting gap distance and determination of maximum gap distance
Maintaining an equal pressure between a medial pressure and a lateral pressure by increasing or decreasing gap distance in the first or second adjustable component with the one or more integral pumps; measuring force throughout a range of motion test with the adjustable spacer in place and the equal gap distance maintained.
Medial and lateral gap distance measurement and determination of maximum gap distance
Measuring a medial gap distance and a lateral gap distance utilizing an optical tracking system throughout the range of motion test; determining a maximum gap distance during the range of motion test; outputting the maximum gap distance for display on a user interface.
Across both independent claims, the inventive concept is to perform knee arthroplasty with an adjustable spacer having one or more integral pumps, keep medial and lateral balance during a range of motion test (equal gap distance or equal pressure), measure with a force sensor device and optical tracking, determine a maximum value (maximum force or maximum gap distance), and output that maximum value for display.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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