US-12616486-B2 - Systems, methods, and apparatuses for tibial mechanical axis digitization

US12616486B2US 12616486 B2US12616486 B2US 12616486B2US-12616486-B2

Abstract

A system may include an implantable device having at least a first sensor configured to collect first data regarding one or more characteristics of a bone of a patient, wherein the implantable device is configured for implantation in a medullary canal of the tibia. The system may include an attachment member configured to couple with the implantable device when the implantable device is implanted in the medullary canal of the tibia. The system may further include a targeting device moveably coupled to the attachment member, wherein the targeting device is configured to reference a distal anatomy of a leg, and wherein the targeting device has at least a second sensor configured to collect second data regarding at least a position of the targeting device.

Inventors

Manon GAUTIER
Elaine HUANG
Martine BLOUIN
Joseph MADIER VIGNEUX

Assignees

ORTHOSOFT ULC

Dates

Publication Date: 20260505
Application Date: 20231114

Claims (14)

1 . A system for determining an orientation of a mechanical axis of a tibia, the system comprising: an implantable device having at least a first sensor configured to collect first data regarding one or more characteristics of a bone of a patient, wherein the implantable device is configured for implantation in a medullary canal of the tibia; an attachment member configured to couple with the implantable device when the implantable device is implanted in the medullary canal of the tibia; a targeting device moveably coupled to the attachment member, wherein the targeting device is configured to reference a distal anatomy of a leg, and wherein the targeting device has at least a second sensor configured to collect second data regarding a position and/or orientation of the targeting device; and at least one target element configured to be placed at or adjacent the distal anatomy of the leg, wherein the targeting device includes or can produce a visual alignment guide configured to reference indicia of the at least one target element, the visual alignment guide being a laser emitting element configured to produce a laser beam operable to project onto one or more indicia of the at least one target element, the at least one target element including a first target element configured to reference a lateral side of a malleoli and a second target element configured to reference a medial side of a malleoli, the targeting device being configured to pivot about two or more axes to orient the targeting device to have the laser emitting element project the laser beam onto the indicia of the first target element and is configured to pivot about the two or more axes to orient the targeting device to have the laser emitting element project the laser beam onto the indicia of the second target element; and a controller, communicatively coupled to the first sensor of the implantable device and the second sensor of the targeting device, the controller configured to: determine a first position from the first data, determine an angle of the targeting device, determine a position corresponding to a middle of the malleoli from the second data collected when the laser beam is on the indicia of the first target element and when the laser beam is on the indicia of the second target element, and determine, from the first position, the angle and the position corresponding to the middle of the malleoli, the orientation of the mechanical axis of the tibia.
2 . The system of claim 1 , wherein the controller is configured to determine the position corresponding to the middle of the malleoli from the second data as a function of: compare a position and/or orientation of the laser emitting element of the targeting device relative to the first position to determine the angle of the targeting device; and a time of flight of the laser beam to reach the indicia of the first target element and the indicia of the second target element.
3 . A method of digitizing a mechanical axis of a tibia for a computer-assisted knee arthroplasty, the method comprising: implanting a device within a medullary canal of the tibia; recording a first position of the device within the medullary canal; coupling a targeting device to the device when implanted within the medullary canal; orienting the targeting device to reference a distal anatomy of a leg; sensing a second position of the targeting device when referencing the distal anatomy of the leg; and determining from the first position, the second position and a position of the distal anatomy of the leg, an orientation of the mechanical axis of the tibia, and outputting a tracking of the orientation of the mechanical axis.
4 . The method of claim 3 , wherein the position of the distal anatomy of the leg is a middle of a malleoli.
5 . The method of claim 3 , further comprising: positioning a first target element at or adjacent a lateral side of a malleoli; positioning a second target element at or adjacent a medial side of the malleoli; targeting the first target element with a laser beam while sensing the second position of the targeting device; and targeting the second target element with the laser beam while sensing the second position of the targeting device.
6 . The method of claim 5 , wherein the laser beam is emitted from the targeting device.
7 . The method of claim 5 , wherein at least one of targeting the first target element with the laser beam while sensing the second position of the targeting device and targeting the second target element with the laser beam while sensing the second position of the targeting device includes pivoting the targeting device about two or more axes.
8 . The method of claim 6 , wherein sensing the second position of the targeting device when referencing the distal anatomy of the leg includes determining a position of a laser emitting element.
9 . The method of claim 8 , wherein the determining from the first position, the second position and the position of the distal anatomy of the leg the orientation of the mechanical axis of the tibia includes: determining a time of flight of the laser beam to reach a first target element and a second target element; and determining the position corresponding to a middle of the malleoli based upon the position of the laser emitting element of the targeting device relative to the device in the medullary canal and the time of flight of the laser beam.
10 . A system for determining an orientation of a mechanical axis of a tibia, the system comprising: an implantable device having at least a first sensor configured to collect first data regarding one or more characteristics of a bone of a patient, wherein the implantable device is configured for implantation in a medullary canal of the tibia; a targeting device configured to moveably relative to the implantable device, wherein the targeting device is configured to reference a distal anatomy of a leg, and wherein the targeting device has at least a second sensor configured to collect second data regarding at least a position of the targeting device; at least one target element configured to be placed at or adjacent the distal anatomy of the leg, wherein the targeting device includes a visual alignment guide configured to reference the at least one target element; and a controller communicatively coupled to the first sensor of the implantable device and the second sensor of the targeting device, the controller configured to: intraoperatively receive first data regarding the position of the implantable device within the medullary canal of the tibia, intraoperatively receive the second data regarding the position of the targeting device while referencing the at least one target element, determine based upon at least the second data a position of the distal anatomy of the leg, determine based upon the first data and the position of the distal anatomy of the leg the orientation of the mechanical axis of the tibia, and output the orientation of the mechanical axis for use during a computer-assisted knee arthroplasty.
11 . The system of claim 10 , further comprising an attachment member configured to couple with the implantable device when the implantable device is implanted in the medullary canal of the tibia, and wherein the targeting device is moveably coupled to the targeting device.
12 . The system of claim 10 , wherein the controller is configured to determine the orientation of the distal anatomy of the leg based upon: comparing the second data, which corresponds to an angle of a laser emitting element that emits a laser beam, relative to the first position; and measuring a time of flight of the laser beam to reach the first target element and the second target element.
13 . The system of claim 12 , wherein the targeting device is configured to pivot about two or more axes to orient the targeting device to have the laser emitting element project the laser beam as desired.
14 . The system of claim 13 , wherein the distal anatomy of the leg is a lateral side and a malleoli and a medial side of the malleoli, wherein the at least one target element includes a first target element configured to reference the lateral side of the malleoli and a second target element configured to reference the medial side of the malleoli, and wherein targeting device is moveable to have the laser emitting device project the laser beam onto the first target element and is moveable to have the laser emitting device project the laser beam onto the second target element.

Description

CROSS-REFERENCE TO RELATED APPLICATION The present application claims the priority of U.S. patent application No. 63/425,002, filed on Nov. 14, 2022 and incorporated herein by reference. TECHNICAL FIELD The present disclosure is directed to systems, devices and methods for computer-assisted surgery, such as in arthroplasty procedures. BACKGROUND Arthroplasty procedures involve the use of specialized tools and the implantation of medical devices such as orthopedic implants, into a patient. These orthopedic implants can replicate one or more portions of a joint from which bone has been removed. Typically, once the orthopedic implant is implanted into the patient, or even while it is being implanted, it is difficult to obtain feedback regarding the effectiveness of the implant or the implant procedure. Attempts have been made to obtain data from orthopedic implants using sensors. Efforts in this area are still being actively pursued and refined. However, such “smart” orthopedic implants can be costly, may require redesigns, and can suffer from incomplete sensor data, short battery life, and infrequent data collection. Computer-assisted surgery (CAS) systems such as those that employ inertial-based or microelectro-mechanical sensor (MEMS), trackable members have been developed. One of the principal steps in navigating a bone with inertial sensors is to determine a coordinate system of the bone relative to the sensors, so as to be able to track the orientation of the bone. However, bone axis digitizer devices that support MEMS typically must have multi-point attachments to eliminate movement, may be bulky, and can experience accidental displacement during surgery. OVERVIEW The present subject matter can provide a solution to these and other problems, such as by providing a CAS system that can better accommodate and track orientation and any movement of a bone such as the tibia. This CAS system can utilize a dedicated smart implant (called an implantable device herein) with sensing capability in combination with other system components including a second one or more sensors and a laser assembly to more accurately digitize a mechanical axis of the tibia. The present CAS system also reduces a likelihood of human error, which could result from accidental displacement of sensor(s) during surgery. The disclosed CAS system contemplates that the implantable device can be configured to be coupled to the anatomy and further can be coupled to one or more of the tool(s) to provide a reference from which the tool(s) can be oriented. It is advantageous that the implantable device can be configured to be inserted into the medullary canal, which approximates a position of the mechanical axis of the tibia. Thus, various other tools of the CAS system can reference the implantable device and other anatomy of the patient as discussed further herein. One contemplated use of the CAS systems, methods and apparatuses disclosed herein is during trialing. During a surgical arthroplasty procedure to implant a prosthetic knee joint, trialing involves performing range of motion and other determinations, use of tools such as cut guides to remove diseased bone from the joint and the use of one or more provisional components to obtain proper sizing for permanent orthopedic implants. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates knee joint structures providing suitable environments in which the CAS system in accordance with an example of the present application can be utilized. FIG. 2 shows a method and system of digitizing a mechanical axis of a tibia using a targeting device producing a laser beam and an implantable device having a sensor positioned in a medullary canal of the tibia in accordance with an example of the present application. FIGS. 3-3B are different perspective views illustrating an example system including the targeting device, an attachment member and the implantable device in accordance with an example of the present application. FIGS. 4A and 4B are perspective views of further components of the system of FIGS. 3-3B including target elements being targeted by a laser beam in accordance with an example of the present application. FIG. 5 is a flow diagram of a method of registering a mechanical axis of a tibia for a computer-assisted knee arthroplasty according to an example of the present application. FIG. 6 illustrates a block diagram of an example machine upon which any one or more of the techniques discussed herein may perform in accordance with an example of the present application. DETAILED DESCRIPTION CAS has been developed in order to help a surgeon to alter bones, and to position or orient implants to a desired location. CAS may encompass a wide range of devices, including surgical navigation, pre-operative planning, trialing and various robotic devices. Many conventional techniques of joint arthroplasties do not use a robot, which can result in errors or can lack precision. CAS systems can help to reduce error