# US 12,599,333 B2 · Multi-axial joint laxity testing apparatus and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,599,333 B2 - Document ID: US12599333B2 - Status: Granted - Kind: B2 - Application number: 17/238,786 - Filed: 2021-04-23 - Published: 2021-08-19 - Granted: 2026-04-14 - Earliest claimed: 2018-11-05 - Assignees: The University of North Carolina at Greensboro - Applicants: University of North Carolina at Greensboro - Inventors: Sandra Janine Shultz; Randy Joe Schmitz; James Avery Coppock; Sam Seyedin - Web page: https://patentgrep.com/patent/US12599333B2 ## CPC - A61B 5/4528: {Joints (A61B5/4533, A61B5/4538 take precedence)} - A61B 5/4585: {Evaluating the knee} - A61B 5/0048: {Detecting, measuring or recording by applying mechanical forces or stimuli (A61B5/021, A61B5/4884 and A61B9/00 take precedence)} - A61B 5/1121: {Determining geometric values, e.g. centre of rotation or angular range of movement} - A61B 5/6828: {Leg} - A61B 5/6829: {Foot or ankle} - A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)} - A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet} - A61B 2560/0487: Special user inputs or interfaces - A61B 2562/0252: Load cells - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Knee joint laxity testing apparatus includes a thigh cradle assembly, a shank cradle assembly, and a heel cradle assembly. The apparatus is configured to measure knee laxity in three planes of motion: anterior-posterior translations; varus-valgus rotations; and internal-external rotations. The thigh cradle assembly, shank cradle assembly, and heel cradle assembly are mounted on a common base. A thigh fixation system is attached to the thigh cradle assembly both at the proximal and distal ends to firmly stabilize the thigh in the thigh cradle. The patella pad and distal thigh fixation system are mounted on a U-bar assembly. The distal thigh fixation system includes two condyle pad adjustment arms upon which a respective condyle pad is mounted, and a patella pad mounted to a linear track on an underside of the U-bar assembly. ## Claims ### Claim 1 A knee joint laxity testing apparatus comprising: a base comprising a proximal end and a distal end opposed to the proximal end; a thigh cradle assembly mounted to the base adjacent the proximal end; a U-bar assembly mounted to the base distally to the thigh cradle assembly, wherein the U-bar assembly comprises two vertical bars each having a first end affixed to the base in a stationary position and a second end extending away from the base, a base member configured to span the two vertical bars, and two height adjustment clamps, wherein each of the two height adjustment clamps are disposed adjacent one of opposed lateral ends of the base member and configured to slidably engage one of the two vertical bars such that the base member can slidably move relative to and along a length of the two vertical bars between the first end and second end thereof; a shank cradle assembly disposed distally to the U-bar assembly along the base, wherein the shank cradle assembly comprises a contoured shank cradle having a concave top surface configured to contact a calf of a leg, and an opposed bottom surface, and wherein the shank cradle assembly further comprises a linear actuator having a selectively movable action end attached to the bottom surface of the shank cradle and a bottom end, opposite to the action end, affixed to the base such that the linear actuator is vertically aligned between a portion of the base and a portion of the shank cradle and a line perpendicular to the base extends through the concave top surface and bottom surface of the shank cradle and selectively movable action end of the linear actuator; and a heel cradle assembly mounted to the base distally to and separately from the shank cradle assembly, wherein the apparatus is configured to measure knee laxity in three planes of motion. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the three planes of motion comprise anterior-posterior translations; varus-valgus rotations; and internal-external rotations. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the thigh cradle assembly further comprises a thigh cradle having a concave shaped curvature and at least two clamping arms coupled to the thigh cradle on a proximal end thereof opposite a distal end thereof, which is closest to the U-bar assembly, and wherein the clamping arms are configured for securing a thigh positioned against the concave shaped curvature of the thigh cradle. ### Claim 4 (depends on 3) The apparatus of claim 3, further comprising a patella pad mounted along and extending away from a bottom surface of the base member of the U-bar assembly and a distal thigh fixation system mounted to the base member and having at least a portion extending away from the bottom surface thereof, wherein the bottom surface of the base member is disposed closest to the base of the apparatus. ### Claim 5 (depends on 4) The apparatus of claim 4, wherein the distal thigh fixation system comprises two condyle pads, wherein each of the two condyle pads is attached to and guided by a respective condyle pad adjustment arm, wherein the respective condyle pad adjustment arm is disposed through the base member and a respective condyle pad is affixed to a downward extending end of the respective condyle pad adjustment arm, wherein the downward extending end is disposed furthest away from the bottom surface of the base member relative to other portions of the respective condyle pad adjustment arm. ### Claim 6 (depends on 5) The apparatus of claim 5, wherein the two condyle pads are configured to be adjustable along a first line perpendicular to the bottom surface the base member and along a second line parallel to the bottom surface of the base member. ### Claim 7 (depends on 5) The apparatus of claim 5, wherein the U-bar assembly further comprises a linear track disposed adjacent to and along the bottom surface, extending between the lateral ends, wherein the patella pad is slidably affixed to the linear track and wherein the linear track is configured to allow the patella pad to move between the lateral ends. ### Claim 8 (depends on 4) The apparatus of claim 4, wherein the patella pad has a contact surface configured to be moved along a line perpendicular to the bottom surface of the base member and selectively locked at various points along the line at various distances away from the bottom surface. ### Claim 9 (depends on 3) The apparatus of claim 3, wherein a diameter of the concave shaped curvature of the thigh cradle narrows diametrically from the proximal end thereof to the distal end thereof. ### Claim 10 (depends on 8) The apparatus of claim 8, wherein the contact surface of the patella pad is at least one of cushioned, deformable, and resilient. ### Claim 11 (depends on 1) The apparatus of claim 1, wherein the linear actuator is affixed to the base between the U-bar assembly and a heel cradle of the heel cradle assembly. ### Claim 12 (depends on 1) The apparatus of claim 1, wherein the heel cradle assembly further comprises an internal-external (IE) rotational fixture mounted on a carriage, and a heel cradle mounted on the IE rotational fixture. ### Claim 13 (depends on 12) The apparatus of claim 12, wherein the carriage has a bottom surface mounted to a first linear track extending in a direction perpendicular to a line extending through the proximal end and distal end of the base to facilitate varus-valgus laxity testing. ### Claim 14 (depends on 13) The apparatus of claim 13, wherein the heel cradle is mounted on the IE rotational fixture via a rotary shaft and further comprising a second linear track affixed to a top surface of the carriage, wherein the top surface of the carriage is opposite the bottom surface and the second linear track is shorter in length than the first linear track and extends in a direction perpendicular to the first linear track and parallel to the line extending through the proximal end and distal end of the base. ### Claim 15 A system for knee joint laxity testing, the system comprising: a knee joint laxity testing apparatus engageable with a person's knee, the knee joint laxity testing apparatus comprising a base comprising a proximal end and a distal end opposed to the proximal end, a thigh cradle assembly mounted to the base adjacent the proximal end, a U-bar assembly mounted to the base distally to the thigh cradle assembly, wherein the U-bar assembly comprises two vertical bars each having a first end affixed to the base in a stationary position and a second end extending away from the base, a base member configured to span the two vertical bars, and two height adjustment clamps, wherein each of the two height adjustment clamps are disposed adjacent one of opposed lateral ends of the base member and configured to slidably engage one of the two vertical bars such that the base member can slidably move relative to and along a length of the two vertical bars between the first end and second end thereof, a shank cradle assembly disposed distally to the U-bar assembly along the base, wherein the shank cradle assembly comprises a contoured shank cradle having a concave top surface configured to contact a calf of a leg, and an opposed bottom surface, and wherein the shank cradle assembly further comprises a linear actuator having a selectively movable action end attached to the bottom surface of the shank cradle and a bottom end, opposite to the action end, affixed to the base such that the linear actuator is vertically aligned between a portion of the base and a portion of the shank cradle and a line perpendicular to the base extends through the concave top surface and bottom surface of the shank cradle and selectively movable action end of the linear actuator, and a heel cradle assembly mounted to the base distally to and separately from the shank cradle assembly, wherein the knee joint laxity testing apparatus is configured to measure knee laxity values in three planes of motion; a controller coupled to the knee joint laxity testing apparatus, the controller configured to receive the measured knee laxity values in three planes of motion; and the controller further configured to display, on a user interface of a computing device, the measured knee laxity values in three planes of motion. ### Claim 16 (depends on 15) The system of claim 15, wherein the computing device comprises a processor communicably coupled to at least one memory; and program instructions which when executed by the processor cause the processor to: receive, from the controller, the measured knee laxity values in three planes of motion; and display, on the user interface of the computing device, a level of deviation of a measured knee laxity value from a predetermined value. ### Claim 17 (depends on 15) The system of claim 15, wherein the three planes of motion comprise anterior-posterior translations; varus-valgus rotations; and internal-external rotations. ### Claim 18 (depends on 17) The system of claim 17, wherein the controller is in communication with at least one motor configured to perform one of: the anterior-posterior translations; the varus-valgus rotations; and the internal-external rotations. ### Claim 19 (depends on 18) The system of claim 18, wherein the controller is in communication with at least one sensor configured to sense one or more of a force and a displacement resulting from one of: the anterior-posterior translations; the varus-valgus rotations; and the internal-external rotations. ### Claim 20 (depends on 15) The system of claim 15, wherein the thigh cradle assembly further comprises a thigh cradle having a concave shaped curvature and at least two clamping arms coupled to thigh cradle on a proximal end thereof opposite a distal end thereof, which is closest to the U-bar assembly, and wherein the clamping arms are configured for securing a thigh positioned against the concave shaped curvature of the thigh cradle. ### Claim 21 (depends on 20) The system of claim 20, further comprising a patella pad mounted along and extending away from a bottom surface of the base member of the U-bar assembly and a distal thigh fixation system mounted to the base member and having at least a portion extending away from the bottom surface thereof, wherein the bottom surface of the base member is disposed closest to the base of the apparatus. ### Claim 22 (depends on 21) The system of claim 21, wherein the distal thigh fixation system comprises two condyle pads, wherein each of the two condyle pads is attached to and guided by a respective condyle pad adjustment arm, wherein the respective condyle pad adjustment arm is disposed through the base member and a respective condyle pad is affixed to a downward extending end of the respective condyle pad adjustment arm, wherein the downward extending end is disposed furthest away from the bottom surface of the base member relative to other portions of the respective condyle pad adjustment arm. ### Claim 23 (depends on 22) The system of claim 22, wherein the two condyle pads are configured to be adjustable along a first line perpendicular to the bottom surface the base member and along a second line parallel to the bottom surface of the base member. ### Claim 24 (depends on 22) The system of claim 22, wherein the U-bar assembly further comprises a linear track disposed adjacent to and along the bottom surface, extending between the lateral ends, wherein the patella pad is slidably affixed to the linear track and wherein the linear track is configured to allow the patella pad to move between the lateral ends. ### Claim 25 (depends on 21) The system of claim 21, wherein the patella pad has a contact surface configured to be moved along a line perpendicular to the bottom surface of the base member and selectively locked at various points along the line at various distances away from the bottom surface. ### Claim 26 (depends on 20) The system of claim 20, wherein a diameter of the concave shaped curvature of the thigh cradle narrows diametrically from the proximal end thereof to the distal end thereof. ### Claim 27 (depends on 25) The system of claim 25, wherein the contact surface of the patella pad is at least one of cushioned, deformable, and resilient. ### Claim 28 (depends on 15) The system of claim 15, wherein the linear actuator is affixed to the base between the U-bar assembly and a heel cradle of the heel cradle assembly. ### Claim 29 (depends on 15) The system of claim 15, wherein the heel cradle assembly further comprises an internal-external (IE) rotational fixture mounted on a carriage, and a heel cradle mounted on the IE rotational fixture. ### Claim 30 (depends on 29) The system of claim 29, wherein the carriage has a bottom surface mounted to a first linear track extending in a direction perpendicular to a line extending through the proximal end and distal end of the base to facilitate varus-valgus laxity testing. ### Claim 31 (depends on 30) The system of claim 30, wherein the heel cradle is mounted on the IE rotational fixture via a rotary shaft and further comprising a second linear track affixed to a top surface of the carriage, wherein the top surface of the carriage is opposite the bottom surface and the second linear track is shorter in length than the first linear track and extends in a direction perpendicular to the first linear track and parallel to the line extending through the proximal end and distal end of the base.