Patent Application
20220133291
The present invention relates generally to the field of surgical tools for use during planning and preparation of a joint replacement procedure, and more particularly to a force measuring lever for use during joint distraction.
Over time, as a result of disease, injury, or longevity of use, bones of a joint may degenerate, resulting in pain and diminished functionality. To reduce pain and restore functionality, a joint replacement procedure may be necessary. Examples of such procedures may be total or partial knee arthroplasty, total hip arthroplasty, or knee or hip resurfacing. In these procedures, portions of a patient's joint are replaced with artificial components. Particularly, a surgeon uses a surgical cutting tool to remove portions of bone to prepare the bone to receive a prosthetic device. Prior to resection of the bone, the surgeon plans bone preparation specific to the patient's anatomy, size, current state of the target joint, and several other factors in order to determine the portions of the bone that will be removed and replaced by one or more prosthetic components, as well as to determine proper positioning of the one or more prosthetic components.
One step of surgical planning for a partial knee resurfacing procedure involves a knee joint distraction, that is, forced separation of the distal femur from the proximal tibia. For partial knee resurfacing, this is intended to correct knee joint deformity and cause proper re-tensioning of the ligaments of the knee to determine a desired, post-procedure joint construction. In one exemplary method, prior to resection and prior to a creating a final implant plan, the knee joint deformity is corrected at multiple flexion positions or flexion angles by distracting the joint. An instantaneous six degree-of-freedom (DOF) position (i.e. the pose) of the femur with respect to the six DOF position of the tibia is captured at each of the multiple flexion positions. For example, a common flexion position is near full extension where the surgeon applies a valgus torque to the tibia when the leg is at approximately 5-10 degrees of flexion. The valgus torque corrects the limb alignment deformity and returns the ligaments to a proper tension state. Another common flexion position is 90 degrees flexion. With these two poses, the knee joint is in the desired post-resection final position. After collection of poses, bone resection, implant positioning, and implant characteristics are planned so as to maintain this relative alignment by making the femoral and tibial components contact (or be slightly gapped to allow for some laxity). Once the bone is resected at this desired plan and the trials and/or implants are secured to the bone, the leg will then be in the pre-resected posed positions.
A first technique currently used to apply a joint distraction force includes manually applying a valgus torque (for a varus knee) to the tibia portion of a patient's leg to pivot the knee joint about the contralateral compartment (lateral compartment for a varus knee). Another technique includes applying a distraction force using a common surgical osteotome by levering the osteotome off the front of the tibia and lifting the femur vertically. Similarly, joint distraction may be performed by placing shim-like spoons or gap sticks between the femur and tibia, or by using laminar spreaders to create the distance between the femur and the tibia.
However, for each of these techniques, the “proper” joint distraction force is subjective, varies from surgeon-to-surgeon, and is difficult for surgeons to learn. In addition, for the first technique described above, applying a valgus torque to the tibia for any pose after 30 degrees flexion is extremely difficult because the femur tends to rotate about the femoral head.
Other types of distractors include spring-based, electromechanical, or hydraulic opposing plate spreaders. However, these tend to be large and complex, and due to their size generally require at least some bone to be removed first (provisional resection) to accommodate the device's opposing plates. Yet another device is a force sensing shim. However, like the shim-like spoons or gap sticks, this device generally requires iteratively inserting the device into the joint with various thicknesses until the desired force is achieved, making it time consuming and cumbersome.
According to one aspect, the present disclosure is directed to a joint distraction lever having a lever body having a handle portion and a working portion. The joint distraction lever includes a fulcrum extending from a bottom surface of the working portion of the lever body, and a distal tip, where the distal tip is raised above a top surface of the working portion of the lever body. The joint distraction lever also includes a force measurement device for measuring a distraction force applied at the distal tip during a distraction procedure for a joint, during which a torque is applied at the handle portion of the lever body. In addition, the joint distraction lever includes a force value output that indicates the distraction force applied at the distal tip.
According to another aspect, the present disclosure is directed to a method for applying a distraction force during a distraction procedure. The method includes providing a joint distraction lever comprising. The joint distraction lever has a lever body with a handle portion coupled to a working portion, a fulcrum extending from a bottom surface of the working portion of the lever body, and a distal tip that is raised above a top surface of the working portion of the lever body. The joint distraction lever also includes a force measurement device that measures the distraction force, and a force value output that indicates the distraction force applied at the distal tip. Further, the method includes inserting the joint distraction lever into a space between a first bone and a second bone of a joint, and applying a force to the handle portion of the joint distraction lever. In addition, the method includes measuring the distraction force via the force measurement device, and outputting the measured distraction force by the force value output.
The invention is capable of other embodiments and of being practiced or being carried out in various ways. Alternative exemplary embodiments relate to other features and combinations of features as may be generally recited in the claims.
The invention will become more fully understood from the following detailed description, taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like elements, in which:
Before turning to the figures, which illustrate the exemplary embodiments in detail, it should be understood that the application is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology is for the purpose of description only and should not be regarded as limiting.
Referring to
The osteotome 10 preferably has a thin, narrow lever body 12 sized to be inserted into a pre-resection narrow joint space. The lever body 12 may be between 1-3 mm thick at the working portion 16, and in a preferred embodiment is no more than 2 mm thick. In some preferred embodiments, the thickness of the working portion 16 tapers towards the distal tip 20 to no more than 1 mm thick at the distal tip 20. The width of the working portion 16 may be between 10-22 mm wide to accommodate compartments of various sizes, and in a preferred embodiment is approximately 15 mm wide.
Referring to
The joint distraction device according to various embodiments is dependent on the force being applied at two known locations: the fulcrum 18 and the distal tip 20. To ensure that forces are being applied only at these two locations, the fulcrum 18 and the distal tip 20 project from the bottom face 12b and the top face 12a, respectively, of lever body 12 such that the lever body 12 does not inadvertently contact either bone of the joint.
As such, the fulcrum 18 is designed to project from the bottom face 12b to a distance sufficient to prevent contact of the bottom face 12b with the tibia 30 during use. In a preferred embodiment, the fulcrum 18 extends proud of the lever body 12 by at least 2 mm, but may be anywhere between 1-3 mm proud of the lever body 12, or more. In certain embodiments, the widest portion of the fulcrum 18 is between 4-8 mm, and the thickest portion is between 1-2 mm. The fulcrum may be instrumented such that the fulcrum itself is configured to measure the load being applied at the fulcrum. In such an embodiment, an instrumented fulcrum can be attached to a standard osteotome to achieve certain features of the disclosed embodiments without further modification to force measuring aspects of the osteotome. As shown in the embodiment of
In the embodiment shown in
The distraction force, and thus the measurement of the distraction force applied through the distal tip 20 (to be discussed in detail below), is sensitive to fulcrum 18 to lift point (distal tip 20) distance. When the distance from the fulcrum 18 to the raised distal tip 20 is known or selected, which it will be when the joint distraction lever is used, the applied distraction force can be calculated. The fulcrum 18 to distal tip 20 distance may be fixed or may be variable and/or adjustable. In a fixed fulcrum to tip embodiment, the spacing may be between 10-25 mm. An adjustable distance embodiment may allow for a greater range of the fulcrum to tip distance.
Referring to
The profile of the lever body 12, particularly the distal tip 20, may take on various profiles, not limited to the pointed distal tip shown in the previous embodiments. In one exemplary configuration, such as that shown in
The joint distraction lever may have a rotatable handle portion 14. The rotatable handle portion 14 may allow for a reduction in the amount of torque working laterally during joint distraction. For example, when distracting the knee joint, it is intended to provide the distraction force substantially parallel with the mechanical axis of the joint. However, the surgeon may not be able to achieve exact access and grip on the tool such that all forces are being applied in this direction. Some torque, instead, may be applied sideways on the joint while also being applied in parallel with the mechanical axis. The rotatable handle portion 14 may counteract some of the sideways torque applied by cooperating with the twisting that may occur on the handle when the force is applied at the handle portion 14.
The joint distraction lever, such as osteotome 10, is configured to measure and provide output related to the distraction force applied to the bone of the joint, such as the femur 40, by the distal tip 20 during a distraction procedure. The distraction force is measured by a force measurement device. The embodiment of
Another non-electronic configuration for determining the distraction force applied at the distal tip 20 is an analog torque wrench that is configured to apply a set specific torque to the wrench body or, particularly, lever body 12. Analog graduations of torque settings may be available, and once determined and set, the lever body 12 will be configured to apply a torque and thus cause a distraction force at the distal tip 20 until a predetermined, desired force is applied. When the preset torque has been met, the wrench, or lever, is configured to indicate that the preset torque has been reached, or otherwise prevent further torque from being applied through the lever body.
In another exemplary embodiment, the force measurement device is a strain gauge. One or more strain gauges may be coupled with the lever body 12 and configured to receive an input voltage provided by a power source. In certain embodiments, the power source is a battery. The battery may be disposable, rechargeable, or take the form of a chargeable capacitor. As the electrical conductor of the strain gauge deforms, as the joint distraction lever deforms as the torque is applied to distract the bones of the joint, the electrical resistance of the electrical conductor of the strain gauge changes. Thus, from the measured electrical resistance of the strain gauge(s), computed using the known or measured input voltage and measured output voltage, the amount of applied stress to the joint distraction lever can be measured and the distraction force computed. A plurality of strain gauges may be arranged and included in the joint distraction lever to form a load cell. The output of the load cell transducer can then be used to convert the force or stress determined by the strain gauges into an electrical signal.
Other mechanisms or tools for measuring the distraction force applied by the joint distraction lever at the distal tip 20 include piezoelectric pressure sensors wherein a charge is generated when a piezoelectric crystal, or other suitable material, of the pressure sensor is stressed. The charge output, or the charge output converted to a voltage signal, for example, may be used to compute and indicate the distraction force being applied by the distraction lever. Similarly, stress to the lever body 12 to compute the distraction force applied at the distal tip 20 can be determined using optical sensors in a cantilever beam configuration. The optical sensors may include an array of optical fibers capable of providing computation of stress and strain by way of wavelength variations between the light source and a detector caused by modifications in the optical fiber body. Finally, a magnetic contact switch may be used to indicate the presence of a load being applied, or can be configured to indicate how much load is being applied.
Referring to
Some embodiments may use a plurality of LEDs. For example, when any force is applied, a first LED may illuminate. Additional LEDs may illuminate successively as the force increases, each illuminating once the force meets a predetermined value. The desired distraction force may be indicated when all of the LEDs on the lever are illuminated.
Similarly, instead of an LED 24, the indicator 22 may provide feedback in the form of a sound emitted from the osteotome, such as a beep or click, or arrangement thereof indicating, for example, a first, second, and third state. Alternatively, the osteotome 10 may provide a single beep, click, or other sound only when the desired, predetermined force value has been reached. Likewise, the indicator 22 may provide feedback in the form of haptic vibration of the joint distraction lever. As with the LED 24 and the sound indicator, the haptic vibration may indicate to a user various of ranges of distraction force being achieved, or provide feedback only at the desired, predetermined distraction force value.
In the mechanical embodiment of
In some embodiments, the joint distraction lever may have a preset target distraction force value, and/or preset force values representing the various force stages. In such embodiments, the various indicators indicate when the preset value is reached. In other embodiments, the joint distraction lever may be adjustable. In this way, the surgeon may set the output, i.e., the feedback provided by the indicator, for a selected amount of force. In one example, the surgeon may use the joint distraction lever to first distract the joint. When the surgeon is applying the necessary and desired amount of force to cause distraction of the joint, he or she can set that as the force value that generates a certain output, for example, the force that causes the LED to illuminate. In this way, the same load can be applied consistently and repeatedly by applying a force until that output is again observed. In one exemplary embodiment, shown in
Referring now to
As shown in
The osteotome 10 has a thin, narrow lever body 12 sized to be inserted into a joint space. In various embodiments, the lever body 12 is between 1-3 mm thick at the working portion 16 and, in certain embodiments, no more than 2 mm thick. Additionally, in some embodiments, the thickness of the working portion 16 tapers towards the distal tip 20 to no more than 1 mm thick at the distal tip 20. The width of the working portion 16 may be between 10-22 mm wide to accommodate compartments of various sizes and, in some embodiments, is approximately 15 mm wide.
The handle portion 14 is configured to be gripped by a user during use of the osteotome 10. As such, the handle portion 14 may be provided with a number of grip grooves 42 on the top face 12a and the bottom face 12b of the osteotome 10. Although the handle portion 14 is static in the embodiment shown in
The working portion 16 is configured to transmit a force provided by a user at the handle portion 14 to a bone of a joint. Referring now to
Accordingly, the joint distraction device according to various embodiments is dependent on the force being applied at two known locations: the fulcrum 18 and the distal tip 20. To ensure that forces are being applied only at these two locations, the fulcrum 18 and the distal tip 20 project from the bottom face 12b and the top face 12a, respectively, of the lever body 12 such that the lever body 12 does not inadvertently contact either bone of the joint.
Referring first to the fulcrum 18, the fulcrum 18 is designed to project from the bottom face 12b to a distance sufficient to prevent contact of the bottom face 12b with the tibia 30 during use. In one embodiment, the fulcrum 18 extends proud of the lever body 12 by at least 2 mm but may be anywhere between 1-3 mm or more proud of the lever body 12. In certain embodiments, the widest portion of the fulcrum 18 is between 4-8 mm, and the thickest portion is between 1-2 mm. The fulcrum may be instrumented such that the fulcrum itself is configured to measure the load being applied at the fulcrum. In such an embodiment, an instrumented fulcrum can be attached to a standard osteotome to achieve certain features of the disclosed embodiments without further modification to force-measuring aspects of the osteotome.
The fulcrum 18 may be designed in various shapes. In one embodiment, the fulcrum 18 is shaped as two “teeth” that extend laterally across the bottom face 12b of the working portion 16. The teeth are configured to be sharp enough to “bite” (e.g., penetrate a small distance to hold the osteotome 10 in place) into the bone that the osteotome 10 rests on during the distraction of the joint but not so sharp that the teeth penetrate far into or cause damage to the bone. However, in other embodiments, the fulcrum 18 may be a flat, linear fulcrum, a triangular fulcrum, and so on. Further, in some embodiments, the fulcrum 18 may be connected to the lever body 12 at a rotatable pivot joint.
The distraction force, and thus the measurement of the distraction force applied through the distal tip 20 (to be discussed in detail below) is sensitive to the distance between the fulcrum 18 and the lift point (e.g., distal tip 20 in the embodiment shown in
As shown in
While
As shown in
In various embodiments, the joint distraction lever, such as osteotome 10, is configured to measure and provide an output related to the distraction force applied to the bone of the joint by the joint distraction lever during the distraction procedure. The distraction force is measured by a force measurement device, which may be mechanical or electronic.
The embodiment of the osteotome 10 illustrated in
In various embodiments, a plurality of strain gauges may be arranged and included in the joint distraction lever to form a load cell. The output of the load cell transducer can then be used to convert the force or stress determined by the strain gauges into an electrical signal. In the embodiment shown in
As discussed above, the hinged connection between the handle portion 14 and the working portion 16 at the connecting bar 46 allows the working portion 16 to pivot relative to the handle portion 14 during a distraction procedure. Accordingly, when a torque is applied to the handle portion 14 during a distraction procedure, the sensor indentor 54 pivots upward to contact and deform the load cell 50. The more torque that is applied at the handle portion 14 during the procedure, the more the sensor indentor 54 will deform the load cell 50. The deformation of the load cell 50 may thus be used to measure the amount of applied torque, as discussed above.
Alternatively, in other embodiments, a load cell may be provided at any location on the osteotome. For example, while the embodiment shown in
In various embodiments, the osteotome also includes a force value output. In some embodiments, the force value output is one or more indicators on the osteotome. The indicator(s) provide feedback to a user related to the distraction force being applied to a first bone of the joint, such as the femur 40, at the distal tip 20. The feedback may indicate the current value of the force being applied, or the feedback may be representative of a particular range of force values (i.e. provide feedback when a predetermined force value has been reached or exceeded). The feedback provided via the indicator allows for consistent, repeatable, trainable force application. Distinct from prior methods and systems for joint distraction where force is subjective, changes between surgeons, and is difficult to learn, the joint distraction lever according to the disclosed embodiments provides feedback to the user such that consistent force can be quantified and applied uniformly among different surgeons, between one distraction procedure and the next, and at any flexion angle. In certain embodiments, the osteotome 10 is configured to apply a force of 85 N+/−15 N. Accordingly, the indicator(s) are configured to provide feedback to the user when the distraction force achieves some predetermined relationship with this desired force value.
In
For example, in one embodiment, once a battery is inserted into the battery compartment 49 and/or the osteotome is turned on, the LED 60a blinks if no force is currently being applied to the osteotome 10. Once a torque begins to be applied at the distal tip 20, causing the sensor indentor 54 to contact the load cell 50, the LED 60a remains constantly lighted. As the torque is increased, the LEDs 60b-60e light up in succession. When the LEDs 60a-60e are all constantly lit, this indicates to the user that the desired amount of force is being applied to the osteotome 10 (e.g., the amount of force suited for successfully carrying out the distraction procedure). If additional torque is applied to the osteotome 10, the LEDs 60a-60e begin to blink, indicating that the user is applying too much torque to the osteotome 10 (e.g., the user is applying an amount of torque that may injure the patient). In this way, the LEDs 60a-60e aid a user in applying the appropriate amount of force during a distraction procedure such that each distraction procedure may be carried out safely and reliably.
However, it should be understood that this is merely an example of how LEDs 60 may be used to provide feedback to the user during a distraction procedure. Other embodiments of the osteotome 10 may include different numbers of LEDs 60 and/or light the LEDs 60 in a different manner to provide feedback. As another example, the osteotome 10 may instead include a single LED 60. When the osteotome 10 is first inserted in the joint space and no force is being applied, or only a low amount of force is being applied, the LED 60 may emit light of a certain color or remain off. When the distraction force reaches a first level (e.g., 70 N+/−5 N), the LED 60 may emit light of a second color. When the distraction force reaches a second level (e.g., 100 N+/−5 N), the LED 60 may emit light of a third color to indicate that a predetermined, desired distraction force, or a maximum safe distraction force, has been applied. Alternatively, the LED 60 may blink at a slow or a rapid flashing state to provide an indication that a predetermined force has been achieved. As a further alternative, the LED 60 may only light up when a predetermined, desired level of force has been achieved.
Additionally, it should be understood that an indicator may be provided on any part of the osteotome 10. Referring now to
It should further be understood that, while the indicator in
In some embodiments, an indicator for the joint distraction lever may have a preset target distraction force value and/or preset force values representing the various force stages (e.g., different force values associated with a green light and a red warning light). In other embodiments, the indicator for the joint distraction lever may have adjustable force values. In this way, the surgeon may set the output (e.g., the feedback provided by the indicator) for a selected amount of force. For example, a dial with value hashtags may be adjusted to set the force value and/or type of output according to the surgeon's desired load. As another example, an adjustment of the desired or predetermined values may be adjusted via software implemented in the joint distraction lever and/or via the surgical system 900 described below with reference to
In embodiments of the osteotome 10 including an electronic force measurement device, the force value output may be a signal to display a digital representation of the force value on a display window provided on the lever body 12 itself or on a display or indicator device coupled to the lever body 12. Alternatively, or additionally, the osteotome 10 may be configured to communicate the computed force wirelessly with an external system (e.g., an external computing system). As such, the osteotome 10 may include a communications device or network interface such that the osteotome 10 is able to communicate with the external system via Bluetooth, RFID, Wi-Fi, etc. The external system may display the force value on a display device, provide sound feedback, or provide another indicator to the user of the forces being applied by the joint distraction lever based on data, received from the osteotome 10, relating to the distraction force applied by the osteotome 10.
Furthermore, the external system may include software (e.g., implemented as instructions stored in a non-transitory machine-readable medium or memory, the instructions executable by a processor), such as a robotic balancing application, configured to guide the user in performing the distraction procedure or, more broadly, a joint resection. In various embodiments, the external system may communicate with the joint distraction lever to facilitate the distraction procedure. For example, in one embodiment, the external system may identify a stiffness transition point (e.g., the point where a ligament transitions from low stiffness to high stiffness) using an output from the osteotome 10, such as an output of the force measurement device, or using an output from another device or devices. In another embodiment, the osteotome 10 may include a button (e.g., provided on the lever body 12) that the user may push to collect pose data for the resection joint, as described in further detail below with reference to
In some embodiments, the joint distraction lever is implemented as a single joint distraction lever, as illustrated by the osteotome 10 shown in
Referring to
A joint distraction lever, such as the osteotome 10, is then inserted into the space between a first bone and a second bone of the joint (step 704). An external force is then applied to the handle portion 14 of the lever body 12 to cause a torque on the joint distraction lever (step 706). As a result, the user receives feedback related to the amount of distraction force being applied to the first or the second bone of the joint at the distal tip 20 of the joint distraction lever, as measured by components of the joint distraction lever (e.g., a force measurement device, such as load cell 50, etc.) (step 708). After having achieved a predetermined amount of force at the distal tip 20, and being aware of that the predetermined amount of force is being applied by the feedback, the user maintains the external force to the handle portion 14 to complete the joint distraction procedure (step 710).
Optionally, after step 710, a pose of the first and second bones of the joint is captured when the predetermined distraction force is applied and maintained at the distal tip 20 (step 712). Capturing the pose of the first and second bones in the distracted joint assists with surgical planning to ultimately attain the desired, properly aligned joint post-resection and post-prosthetic implantation. To provide for capturing the pose of the joint, the joint distraction lever may be used in conjunction with anatomy navigation systems and methods, which may further be used with a surgical system, such as those depicted in
Determining the pose of the first and second bones in step 712 may make use of the tracking system 940. The tracking (or localizing) system 940 of the surgical system 900 is configured to determine a pose (i.e., position and orientation) of one or more objects during a surgical procedure to detect movement and capture poses of the object(s). For example, the tracking system 940 may include a detection device 941 that obtains a pose of an object with respect to a coordinate frame of reference of the detection device. As the object moves in the coordinate frame of reference, the detection device 941 tracks the pose of the object to detect (or enable the surgical system 900 to determine) movement of the object. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 900. Using pose data from the tracking system 940, the surgical system 900 is also able to register, map, or associate coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). Objects in physical space may be registered to any suitable coordinate system, such as a coordinate system being used by a process running on the computer 921.
For example, utilizing pose data from the tracking system 940, the surgical system 900 is able to associate the physical anatomy with a representation of the anatomy (e.g., an image displayed on a display device 945). Based on tracked object and registration data, the surgical system 900 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy. Additionally, by tracking the relevant anatomy, the surgical system 900 can compensate for and ascertain movement of the relevant anatomy during the surgical procedure, as needed for capturing the pose of the distracted joint at the flexion position.
Registration may include any known registration technique, such as, for example, image-to-image registration (e.g., monomodal registration where images of the same type or modality, such as fluoroscopic images or MR images, are registered and/or multimodal registration where images of different types or modalities, such as MM and CT, are registered); image-to-physical space registration (e.g., image-to-patient registration where a digital data set of a patient's anatomy obtained by conventional imaging techniques is registered with the patient's actual anatomy); and/or combined image-to-image and image-to-physical-space registration (e.g., registration of preoperative CT and MRI images to an intraoperative scene).
The tracking system 940 may also be used to track the anatomy and the joint distraction lever, or osteotome 10, while applying the distraction force. By tracking the pose (i.e., position and orientation) and the movement of the osteotome 10 and the anatomy, the computing system 920 may determine the directional components of the force being produced. As described above, in addition to the forces acting along the mechanical axis of the bone being moved, the distraction force may also act in a lateral direction or other direction off-axis from the mechanical axis. Tracking of the objects used during a distraction procedure and determination of the directional components may allow for a determination of the amount of force that is off of the intended axis. This may help the surgeon adjust the application of force for more efficient load transmission and/or to reduce any injury or damage that may occur may applying distraction forces in directions that are off of the intended axis. Alternatively, the surgical system 900 may be configured to adjust the application of force automatically (e.g., by the computing system 920 or the haptic device 930 providing haptic feedback to the osteotome 10 during the distraction procedure).
The tracking system 940 may be any tracking system that enables the surgical system 900 to continually determine (or track) a pose of the relevant anatomy of the patient and a pose of the surgical tool 935 (and/or the haptic device 930). For example, the tracking system 940 may comprise a non-mechanical tracking system, a mechanical tracking system, or any combination of non-mechanical and mechanical tracking systems suitable for use in a surgical environment.
A non-mechanical tracking system may include, for example, an optical (or visual), magnetic, radio, or acoustic tracking system. Such systems may include a detection device adapted to locate, in a predefined coordinate space, specially recognizable trackable elements (“trackers”) that are detectable by the detection device and that are either configured to be attached to the object to be tracked or are an inherent part of the object to be tracked. For example, a trackable element may include an array of markers having a unique geometric arrangement and, when attached to the tracked object (e.g., the femur 40 and tibia 30 of a patient), a known geometric relationship to the tracked object. These markers may include any known marker, such as extrinsic markers (or fiducials) and/or intrinsic features of the tracked object. Extrinsic markers are artificial objects that are attached to the patient (e.g., markers affixed to skin, markers implanted in bone, stereotactic frames, etc.) and are designed to be visible to and accurately detectable by the detection device 941. Intrinsic features are salient and accurately locatable portions of the tracked object that are sufficiently defined and identifiable to function as recognizable markers for the detection device 941 on their own (e.g., landmarks, outlines of anatomical structure, shapes, colors, or any other sufficiently recognizable visual indicator).
The markers may be located using any suitable detection method, such as, for example, optical, electromagnetic, radio, or acoustic methods as are well known. For example, an optical tracking system having a detection device 941 implemented as stationary stereo camera pair sensitive to infrared radiation may be used to track markers that emit infrared radiation either actively (e.g., as LEDs) or passively (e.g., spherical markers with surfaces that reflect infrared radiation). Similarly, a magnetic tracking system may include a stationary field generator that emits a spatially-varying magnetic field sensed by small coils integrated into the tracked object.
In the embodiment shown in
As stated above, a virtual representation of the anatomy, such as the knee joint, can be displayed on display device 945. The display device 945 may also display the distraction force measurement obtained by a force measurement device of the joint distraction lever. For example, as described above, the osteotome 10 may communicate wirelessly (e.g., Bluetooth, RFID, etc.) or via a coupled connection with the surgical system 900 to provide the distraction force measurement for display on an external device, such as the display device 945. Furthermore, as also described above, the osteotome 10 may include a button in response to which the surgical system 900 captures the pose of the joint using the tracking system 940 (e.g., because pressing the button causes the osteotome 10 to transmit a command to the surgical system 900 to capture the pose of the joint). The surgical system 900 may further display pose information on the display device 945 and/or use the pose information to complete a surgical planning procedure.
Accordingly, in various embodiments, the computing system 920 may be configured to acquire and use the data obtained during a joint distraction procedure, including pose information (e.g., captured in response to the user pressing a button on the osteotome 10), to complete a surgical planning procedure. Thus, computing system 920 may capture and store the pose of the first and second bones of the joint based on information captured and provided by tracking system 940. For example, the captured pose of the joint may be used to plan bone resection and prosthetic implant placement for proper joint balance and alignment. The computing system 920 of surgical system 900 may be further configured to define a surgical plan based on the captured pose(s) of the distracted joint. The surgical system 900 may then implement the surgical plan, for example, by using the tracking system 940 to track the pose of a surgical tool relative to the patient's anatomy and providing haptic feedback through the haptic device 930 (e.g., based on a position and orientation of a surgical tool 935 relative a haptic boundary created during surgical planning). The haptic feedback provided by the haptic device 930 provides surgical guidance to a surgeon in order to keep the surgical tool 935 from deviating from the surgical plan created based on the joint distraction procedure and other aspects of surgical planning.
Moreover, the computing system 920 may provide surgical guidance to a surgeon during the joint distraction procedure. For example, the computing system 920 may identify a stiffness transition point for the joint (e.g., based on pose information captured by the tracking system 940, based on pre-operative scans of the patient anatomy, based on force information transmitted to the computing system 920 by the osteotome, etc.). The computing system 920 may then provide guidance to the surgeon by, for example, displaying the stiffness transition point on a representation of the patient anatomy via the display device 945.
U.S. Pat. No. 8,010,180, titled “Haptic Guidance System and Method,” granted Aug. 30, 2011, which is hereby incorporated by reference herein in its entirety, describes an exemplary surgical system with which the presently described joint distraction lever may be used during a joint distraction procedure and for bone resection and implant planning.
Referring back to the method depicted in
In various arrangements, these poses of the flexion position(s), with the predetermined distraction force applied, represent the desired post-resection final position of the joint (e.g., the knee joint). Accordingly, after collecting the poses, bone resection, implant positioning, and implant characteristics are planned (e.g., using the computing system 920) so as to maintain this relative alignment by making the femoral and tibial components contact or be slightly gapped to allow for some laxity. Once the bone is resected at this desired plan and the trials and/or implants are secured to the bone, the leg will be in the desired pre-resected posed positions.
Various exemplary embodiments of the invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the invention. Various changes may be made to the invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. Further, as will be appreciated by those with skill in the art that each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions. All such modifications are intended to be within the scope of claims associated with this disclosure.
The invention includes methods that may be performed using the subject devices. The methods may include the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the “providing” act merely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method. Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as in the recited order of events.
Exemplary aspects of the invention, together with details regarding material selection and manufacture have been set forth above. As for other details of the present invention, these may be appreciated in connection with the above-referenced patents and publications as well as generally known or appreciated by those with skill in the art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts as commonly or logically employed.
In addition, though the invention has been described in reference to several examples optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to each variation of the invention. Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. In addition, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention.
This application is a continuation-in-part of U.S. patent application Ser. No. 16/447,507, filed Jun. 20, 2019, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/688,151, filed Jun. 21, 2018; this application is also a continuation-in-part of U.S. patent application Ser. No. 17/132,053, filed Dec. 23, 2020, which is a divisional of U.S. patent application Ser. No. 14/724,381, filed May 28, 2015, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/004,015, filed May 28, 2014; all of which are incorporated by reference herein in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 62688151 | Jun 2018 | US | |
| 62004015 | May 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14724381 | May 2015 | US |
| Child | 17132053 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16447507 | Jun 2019 | US |
| Child | 17575188 | US | |
| Parent | 17132053 | Dec 2020 | US |
| Child | 16447507 | US |
