The present disclosure relates generally to orthopedic devices and procedures and, more particularly, to a total hip replacement procedure which includes systems and methods for assisting the surgeon to visualize and select the best position of the implant to optimize the tradeoff between range-of-motion and stability and for visualizing the effects of and selecting the optimal placement of the lipped portion of the cup liner of the implant.
Orthopedic implants are well known and commonplace in today's society. Orthopedic implants may be used, for example, to stabilize an injury, to support a bone fracture, to fuse a joint, and/or to correct a deformity. Orthopedic implants may be attached permanently or temporarily and may be attached to the bone at various locations, including being implanted within a canal or other cavity of the bone, implanted beneath soft tissue and attached to an exterior surface of the bone, or disposed externally and attached by fasteners such as screws, pins, and/or wires. Some orthopedic implants allow the position and/or orientation of two or more bone pieces, or two or more bones, to be adjusted relative to one another.
One such orthopedic implant is used during a total hip replacement procedure to replace a hip joint. The hip joint is a frequent place for joint damage and/or injury. Implants used in total hip replacement surgeries may include an elongated insertion portion, referred to herein as the “stem portion”, which can be at least partially inserted into the intramedullary canal of the patient's proximal femur, and a “cup” portion, which is embedded into the pelvis of the patient. The cup portion of the implant accepts the head of the stem portion to allow rotation of the stem portion with respect to the hip bone.
In some instances, excess rotation of the stem portion of the implant with respect to the hip bone and the cup portion of the implant can cause a dislocation. This often occurs, for example, when the stem portion contacts the lip of the cup portion, causing a lateral translation of the center of the femoral head. The lateral translation of the femoral head in excess of a particular distance, based on the geometry of the implant, may result in a dislocation. This distance is known as the “jump distance” and is defined as the distance the femoral head needs to travel to dislocate. The jump distance is illustrated in
During the total hip replacement procedure, the surgeon must cut various muscles and ligaments of the hip capsule, which tends to weaken those muscles and ligaments, limiting their ability to contain the hip joint in the hip capsule post-surgery. The weaker muscles and ligaments in the hip capsule often allow for an easier dislocation. To address this, the cup portion of the implant may be provided with a liner which may have a lipped portion to enhance stability of the joint and to reduce the probability of a dislocation.
When the cup is implanted into the hip bone, the lipped portion of the implant is oriented toward the direction of potential dislocation. For example, the lipped portion may be placed posteriorly for a total hip replacement implanted using a posterior surgical approach to reduce posterior dislocation risk, or anteriorly for anterior or lateral surgical approaches, to reduce anterior dislocation risk. Cups having lipped liners increase the jump distance, and therefore the stability of the implant, in the direction of the orientation of the lipped portion of the liner. However, the lipped liners also decrease the range-of-motion of the implant, because the stem may contact the lipped portion of the liner earlier in the rotation than with a non-lipped liner.
One goal of the surgeon during the total hip replacement surgery is to maximize both the range-of-motion and the jump distance. As such, there is a trade-off between range-of-motion and the probability of a dislocation, as dictated by the jump distance.
In certain surgeries, the hip implant may be provided with a cup liner having a lipped portion. One variable having an effect on the range-of-motion and the jump distance is the positioning of the lipped portion of the liner. For example, as shown in
Currently, pre-operative planning applications and tools do not provide a way for the surgeon to visualize the effect of the positioning of the implant on the range of motion and the jump distance. Further, there is currently no application or tool to visualize the effect of the positioning of the lipped portion of the cup on either the range-of-motion or the jump distance. As such, there is no way for the surgeon, other than through an intuitive positioning of the implant and the lipped portion of the cup, to be able to optimize the tradeoff between the range-of-motion and the jump distance. Therefore, it would be desirable to provide to the surgeon a means of visualizing the effect of the positioning of the implant and the lipped portion of the cup liner on both the range-of-motion and the jump distance, and, in some instances, to provide recommendations as to the optimal placement.
Disclosed herein is a system and method providing a tool for use by a surgeon, either pre-operatively or intra-operatively, to visualize the effect of the orientation of the lipped portion of the cup liner on both the range-of-motion and the jump distance and identify the lip orientation that provides optimal tradeoff between jump distance and range-of-motion when other modifiable or non-modifiable parameters of the entire episode of care (e.g., patient's spinopelvic mobility, pre-selected cup placement, native femoral version) are taken into consideration. This will assist the surgeon in determining the optimal placement of the lipped portion of the cup liner to provide the best outcome for the patient.
In a first example, range-of-motion profiles and jump distance profiles for various orientations of the implant are visualized using a 2D or 3D visual representation of profiles of the implant's range-of-motion and jump distance for possible directions of impingement (of the stem portion of the implant on the edge of the cup portion of the implant). For example, in some examples, the range-of-motion can be visualized on diagrams including a coordinate system showing rotation of the leg of the patient around the X-axis, which approximates flexion/extension of the leg, and the Y-axis, which approximates abduction/adduction of the leg, as shown in
Alternatively, an optimization algorithm can be utilized to minimize a cost function and determine optimal lip orientation, given non-modifiable pre-operative and intra-operative parameters. For example, the cost function might penalize lip orientations that prevent selected hip range-of-motion rotations by more than 10 degrees, and/or maximize jump distance for a given rotation deemed most dangerous for the patient (e.g., combined flexion and internal rotation of the femur for patients operated with a posterior approach).
In a first example, a method includes visualizing a range-of-motion for a plurality of orientations of a hip implant based on various combinations of placement options for a cup portion and a stem portion of the implant and visualizing a jump distance for a plurality of orientations of the implant. (In this example, placement of the cup portion and stem portion are also modifiable factors together with lip orientation and an optimization algorithm can be utilized to find optimal position of the three components (i.e., cup, stem, and liner lip) that maximizes a pre-selected relationship between range-of-motion and jump distance (i.e., cost function)).
In any preceding or subsequent example, the method further includes providing 2D or 3D visualizations of the implant's range-of-motion and jump distance profiles for various possible directions of impingement.
In any preceding or subsequent example, the method further includes providing a visualization of a desired range-of motion of the patient's leg as an overlay on the range-of-motion.
In any preceding or subsequent example, the method further includes visualizing the range-of-motion by plotting one or more profiles representing one or more ranges-of-motion on a coordinate system having a vertical axis defining rotation of the patient's leg around an X-axis and a horizontal axis defining rotation of the patient's leg around a Y-axis.
In any preceding or subsequent example, the method further includes wherein the ranges-of-motion of a patient's leg are visualized as a polygon overlaid on the coordinate system showing the kinematics of a hip based on a positioning of the implant, wherein the plurality of profiles represent different orientations of the implant.
In any preceding or subsequent example, the method further includes determining acceptable orientations of the implant by determining whether the visualization of the ranges-of-motion of the patient's leg representing the kinematics of the hip extends outside of one or more of the profiles representing the range-of-motion.
In any preceding or subsequent example, the method further includes determining the positioning of the cup portion and stem portion of the implant for various cup inclinations, cup anteversions and stem anteversions.
In any preceding or subsequent example, the method further includes plotting a plurality of profiles representing the jump distance on a coordinate system having a vertical axis corresponding to rotations of the patient's leg about an anterior-posterior axis of a cup portion of the implant and a horizontal axis corresponding to rotations of the patient's leg about a medial-lateral axis of the cup axis of the cup portion of the implant.
In any preceding or subsequent example, the method further includes selecting, for each quadrant of the coordinate system, a preferred range-of-motion and jump distance profile such that the range-of-motion and jump distance are maximized for possible directions of impingement.
In any preceding or subsequent example, the method further includes receiving an input of a positioning of the implant.
In any preceding or subsequent example, the method further includes receiving an indication of a cup anteversion, a stem anteversion and a cup inclination and providing a visualization of effect of the placement of a lipped portion of the cup liner on the range-of-motion and jump distance based on the received indications.
In a second example, a system includes a processor and software that, when execute by the processor, causes the system to implement any preceding or subsequent example.
In a third example, the method of any preceding or subsequent example further includes providing a plurality of surgical recommendations based on various possible positionings of the implant.
In any preceding or subsequent example, the method further includes providing a recommendation, based on the received input, for orientation of the lipped portion of the cup liner.
In any preceding or subsequent example, the method further includes analyzing the indicated implant positioning and providing a recommendation of the orientation of the lipped portion of the cup liner via a mathematical algorithm or a machine learning model.
In a fourth example, a system includes a processor and software that, when execute by the processor, causes the system to implement any preceding or subsequent example.
Examples of the present disclosure provide numerous advantages. For example, the described system and method provides a surgeon performing total hip replacement procedures with a tool for visualizing the orientation of the implant and the effect of various orientations on the patient's range-of-motion. Additionally, the system and method provide the further advantage of showing the effect of the orientation of the lipped portion of the cup liner on the jump distance of the implant and its effect on range-of-motion. A further advantage is provided by a pre-operative portion of the system and method which shows the surgeon different options for orientation of the cup and stem components of the implant and the resulting impact on jump distance and the patient's range-of-motion. In a second example, the system and method provide the additional advantage of providing recommendations as to the orientation of the implant based given desired range-of-motion.
Further features and advantages of at least some of the examples of the present disclosure, as well as the structure and operation of various examples of the present disclosure, are described in detail below with reference to the accompanying drawings.
As used herein, the term “visualize” or “visualization” shall be construed to include any means of conveying the required information on a display device, including, for example, a text description, a chart, a graph (for example, on a coordinate system), an illustration, a figure, a drawing, a model, an image, an animation, a video, or any combination thereof.
As used herein, the term “optimize” or “optimization” in the context of providing a recommendation, means selection of parameters that are optimal based on certain specified criteria. In an extreme case, optimization can refer to selecting optimal parameter(s) based on data from the entire episode of care, including any pre-operative data, the state of CASS data at a given point in time, and post-operative goals. Optimization may be performed using historical data, such as data generated during past surgeries involving, for example, the same surgeon, past patients with physical characteristics similar to the current patient, or the like.
By way of example, specific exemplary examples of the disclosed system and method will now be described, with reference to the accompanying drawings, in which:
The system and method disclosed herein provides information to a surgeon during the pre-operative and intra-operative phases of a joint replacement surgery which will assist the surgeon in determining the optimal positioning of the implant. Note that, although the disclosure is explained in terms of a total hip replacement procedure, all or portions of the present disclosure may be applicable to any joint replacement procedure using a ball and socket type of implant.
The system and method visualizes the effects of the placement of the implant on the range-of-motion and jump distance. The system may be used either pre-operatively, to advise the surgeon of the optimal placement given various combinations of cup inclination, cup anteversion and stem anteversion, or intra-operatively after the surgeon has determined an acceptable positioning of the implant based on the patient's anatomy.
Polygon 408 represents the kinematics of a hip showing the desired range-of-motion. The positioning of polygon 308 will vary based on the specific position in which the implant is placed (i.e., cup inclination, cup anteversion and stem anteversion). When polygon 408 is completely within one of profiles 402, 404, 406, there will be no impingement of the stem on the lip of the cup. However, if the polygon 408 touches a profile or extends outside of the profile, impingement will occur, thus limiting the range-of-motion.
The quadrants may be colored to indicate what lip orientation is better (for either range-of-motion or jump distance) for the impingement directions covered by that area. Other indicia (e.g., hatching) may be used to indicate that two orientations are equivalent in that region. So, for example, in the top right quadrant of the range-of-motion plot in
Jump distance is a geometrical property, so it does not change with cup inclination and cup anteversion. However, its relationship with hip physiological ranges of motion will change when changing cup inclination and anteversion. Therefore, the range-of-motion profiles (
In a first example, the plots for range-of-motion and jump distance may be presented to the surgeon, in a format, such as shown in
In the second example, the system may analyze all available data and may recommend an orientation of the implant and the lipped portion of the cup liner. In some features of this example, the recommendation can be provided by a mathematical algorithm, such as a cost optimization algorithm, or by a machine learning model which has been trained on a data set of previous surgical procedures containing data points indicating the placement of the cup and stem portions of the implant as well as the orientation of the lip portion of the cup liner. Alternatively, in other features of the disclosure, the recommendation of one or more possible orientations can be made based on an analysis of the diagrams provided for range-of-motion and jump distance.
In various alternative examples, the range-of-motion and jump distance may be visualized in any convenient way. The visualizations described above and shown in
The systems and methods described herein may be implemented as software application running on a computing system interfaced with a navigated or robotic-assisted surgical platform or, alternatively, as part of the software of the navigated or robotic-assisted surgical platform.
An effector platform 1505 positions surgical tools relative to a patient during surgery. The exact components of the effector platform 1505 will vary, depending on the example employed. For example, for a knee surgery, the effector platform 1505 may include an end effector 1505B that holds surgical tools or instruments during their use. The end effector 1505B may be a handheld device or instrument used by the surgeon (e.g., a NAVIO® hand piece or a cutting guide or jig) or, alternatively, the end effector 1505B can include a device or instrument held or positioned by a robotic arm 1505A.
The effector platform 1505 can include a limb positioner 1505C for positioning the patient's limbs during surgery. One example of a limb positioner 1505C is the SMITH & NEPHEW SPIDER2 system. The limb positioner 1505C may be operated manually by the surgeon or alternatively change limb positions based on instructions received from the surgical computer 1550 (described below).
Resection equipment (not shown in
The effector platform 1505 can also include a cutting guide or jig 1505D that is used to guide saws or drills used to resect tissue during surgery. Such cutting guides 1505D can be formed integrally as part of the effector platform 1505 or robotic arm 1505A or cutting guides can be separate structures that can be removably attached to the effector platform 1505 or robotic arm 1505A. The effector platform 1505 or robotic arm 1505A can be controlled by the system 1500 to position a cutting guide or jig 1505D adjacent to the patient's anatomy in accordance with a pre-operatively or intra-operatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.
The tracking system 1515 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the tracking system 1551 may provide a location and orientation of the end effector 1505B during the procedure. In addition to positional data, data from the tracking system 1515 can also be used to infer velocity/acceleration of anatomy/instrumentation, which can be used for tool control. In some examples, the tracking system 1515 may use a tracker array attached to the end effector 1505B to determine the location and orientation of the end effector 1505B. The position of the end effector 1505B may be inferred based on the position and orientation of the tracking system 1515 and a known relationship in three-dimensional space between the tracking system 1515 and the end effector 1505B. Various types of tracking systems may be used in various examples of the present disclosure including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems.
The display 1525 provides graphical user interfaces (GUIs) that display images the user interface of the navigated surgical platform, as well as a user interface used to display the plots shown in
Surgical computer 1550 provides control instructions to various components of system 1500, collects data from those components, and provides general processing for various data needed during surgery. In some examples, the surgical computer 1550 is a general purpose computer. In other examples, the surgical computer 1550 may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPU) to perform processing. In some examples, the surgical computer 1550 is connected to a remote server over one or more computer networks (e.g., the Internet). The remote server can be used, for example, for storage of data or execution of computationally intensive processing tasks.
In various examples, the systems and methods of the present disclosure may be implemented as a software application executing on surgical computer 1550 integrated with or separate from the software controlling the navigated surgical platform. Also, in various examples, systems and methods of the present disclosure may be implemented as a software application executing on a computing platform other than surgical computer 1550, such as a laptop or tablet computing device. The computing device executing systems and methods of the present disclosure may be in communication with surgical computer 1550.
Various examples of a system and method have been described herein to provide a surgeon performing total hip replacement procedures with a tool for visualizing the orientation of the lipped portion of the cup liner based on the positioning of the cup and stem portions of the implant. In some examples a pre-operative portion may be shown to provide the surgeon with different options as far as cup and stem placement and their impact on various orientations of the lipped portion of the cup liner. In a second example, the system provides an optimal recommendation as to the orientation of the cup liner based on indicated positions of the cup and stem portions of the implant.
As would be realized by one of skill in the art, the present disclosure has been explained in terms of a posterior surgical approach. However, the system is equally applicable to surgeries utilizing anterior or lateral surgical approaches, which would result in different stability provided by the soft tissues surrounding the hip.
Previous methods for selecting the orientation of the cup range from educated guessing to intuitive conclusions based on previous experience of the surgeon and the surgical approach. The system and method disclosed herein provides a heretofore unavailable tool for the surgeon to improve and inform the selection of the orientation of the lipped portion of the cup liner.
This application claims the benefit of U.S. Provisional Patent Application No. 63/291,783, filed Dec. 20, 2021, the contents of which are incorporated herein in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/048821 | 11/3/2022 | WO |
Number | Date | Country | |
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63291783 | Dec 2021 | US |