SYSTEMS AND METHODS FOR NAVIGATION AND CONTROL OF AN IMPLANT POSITIONING DEVICE
An implant positioning device and a method of using the device are described. The positioning device includes an end effector configured to contact an implant component during a surgical procedure, the end effector connected to an actuator for imparting an impact force to the implant component during the surgical procedure, a motor mechanically connected to the actuator and configured to move the actuator to produce one or more impacts on the end effector, thereby imparting the impact force to the implant component, and a control circuit coupled to the motor. The control circuit is configured to generate at least one motor control signal, transfer the at least one motor control signal to the motor, and, as a result of the at least one motor control signal, cause the motor to move the actuator to produce one or more impacts on the end effector.
The present application is a continuation application of U.S. patent application Ser. No. 14/073,999, filed on Nov. 7, 2013, and titled “Systems and Methods for Navigation and Control of an Implant Positioning Device,” which claims the benefit of U.S. Provisional Application No. 61/724,601, filed on Nov. 9, 2012, and titled “Systems and Method for Navigation and Control of an Implant Positioning Device.” The contents of each of these applications are hereby incorporated by reference herein in their entireties.
TECHNICAL FIELDThis present disclosure relates generally to semi-active surgical robotics, and more specifically to systems and methods to provide computer-aided navigation and control of an implant positioning device.
BACKGROUNDThe use of computers, robotics, and imaging to aid orthopedic surgery is well known in the art. There has been a great deal of study and development of computer-aided navigation and robotics systems used to guide surgical procedures. Two general types of semi-active surgical robotics have emerged and have been applied to orthopedic procedures, such as joint arthroplasty. The first type of semi-active robotics attach the surgical tool to a robotic arm that resists movements by the surgeon that deviate from a planned procedure, such as a bone resection. This first type often goes by the term haptic or haptics, which is derived from the Greek word for touch. The second type of semi-active robotics is focused on controlling aspects of the surgical tool, such as speed of a cutting bit. This second type of semi-active robotics is sometimes referred to as free-hand robotics, as a robotic arm does not restrict the surgeon.
Both types of surgical robotics utilize navigation or tracking systems to closely monitor the surgical tool and the patient during a procedure. The navigation system can be used to establish a virtual three dimensional (3-D) coordinate system, within which both the patient and the surgical device will be tracked.
Hip replacement is an area where the use of surgical robotics, advanced imaging, and computer-aided navigation are gaining acceptance. Total hip replacement (THR) or arthroplasty (THA) operations have been performed since the early 1960s to repair the acetabulum and the region surrounding it and to replace the hip components, such as the femoral head, that have degenerated. Currently, approximately 200,000 THR operations are performed annually in the United States alone, of which approximately 40,000 are redo procedures, otherwise known as revisions. The revisions become necessary due to a number of problems that may arise during the lifetime of the implanted components, such as dislocation, component wear and degradation, and loosening of the implant from the bone.
Dislocation of the femoral head from the acetabular component, or cup, is considered one of the most frequent early problems associated with THR, because of the sudden physical and emotional hardship brought on by the dislocation. The incidence of dislocation following the primary THR surgery is approximately 2-6% and the percentage is even higher for revisions. While dislocations can result from a variety of causes, such as soft tissue laxity and loosening of the implant, the most common cause is impingement of the femoral neck with either the rim of an acetabular cup implant, or the soft tissue or bone surrounding the implant. Impingement most frequently occurs as a result of mis-positioning of the acetabular cup component within the pelvis.
Some clinicians and researchers have found incidence of impingement and dislocations can be lessened if the cup is oriented specifically to provide for approximately 15° of anteversion and 45° of abduction; however, this incidence is also related to the surgical approach. For example, McCollum et al. cited a comparison of THAs reported in the orthopaedic literature that revealed a much higher incidence of dislocation in patients who had THAs with a posterolateral approach. McCollum, D. E. and W. J. Gray, “Dislocation after total hip arthroplasty (causes and prevention)”, Clinical Orthopaedics and Related Research, Vol. 261, p. 159-170 (1990). McCollum's data showed that when the patient is placed in the lateral position for a posterolateral THA approach, the lumbar lordotic curve is flattened and the pelvis may be flexed as much as 35°. If the cup was oriented at 15°-20° of flexion with respect to the longitudinal axis of the body, when the patient stood up and the postoperative lumbar lordosis was regained, the cup could be retroverted as much as 10°-15° resulting in an unstable cup placement. Lewinnek et al. performed a study taking into account the surgical approach utilized and found that the cases falling in the zone of 15°±10° of anteversion and 40°±10° of abduction have an instability rate of 1.5%, compared with a 6% instability rate for the cases falling outside this zone. Lewinnek G. E., et al., “Dislocation after total hip-replacement arthroplasties”, Journal of Bone and Joint Surgery, Vol. 60-A, No. 2, p. 217-220 (March 1978). The Lewinnek work essentially verifies that dislocations can be correlated with the extent of malpositioning, as would be expected. The study does not address other variables, such as implant design and the anatomy of the individual, both of which are known to greatly affect the performance of the implant.
The design of the implant significantly affects stability as well. A number of researchers have found that the head-to-neck ratio of the femoral component is the key factor of the implant impingement, see Amstutz H. C., et al., “Range of Motion Studies for Total Hip Replacements”, Clinical Orthopaedics and Related Research Vol. 111, p. 124-130 (September 1975). Krushell et al. additionally found that certain long and extra-long neck designs of modular implants can have an adverse effect on the range of motion. Krushell, R. J., Burke D. W., and Harris W. H., “Range of motion in contemporary total hip arthroplasty (the impact of modular head-neck components)”, The Journal of Arthroplasty, Vol. 6, p. 97-101 (February 1991). Krushell et al. also found that an optimally oriented elevated-rim liner in an acetabular cup implant may improve the joint stability with respect to implant impingement. Krushell, R. J., Burke D. W., and Harris W. H., “Elevated-rim acetabular components: Effect on range of motion and stability in total hip arthroplasty”, The Journal of Arthroplasty, Vol. 6 Supplement, p. 1-6, (October 1991). Cobb et al. have shown a statistically significant reduction of dislocations in the case of elevated-rim liners, compared to standard liners. Cobb T. K., Money B. F., Ilstrup D. M., “The elevated-rim acetabular liner in total hip arthroplasty: Relationship to postoperative dislocation”, Journal of Bone and Joint Surgery, Vol 78-A, No. 1, p. 80-86, (January 1996). The two-year probability of dislocation was 2.19% for the elevated liner, compared with 3.85% for standard liner. Initial studies by Maxian et al. using a finite element model indicate that the contact stresses and therefore the polyethylene wear are not significantly increased for elevated rim liners; however, points of impingement and subsequent angles of dislocation for different liner designs are different, as would be expected. Maxian T. A., et al. “Femoral head containment in total hip arthroplasty: Standard vs. extended lip liners”, 42nd Annual meeting, Orthopaedic Research society, p. 420, Atlanta, Ga. (Feb. 19-22, 1996); and Maxian T. A., et al. “Finite element modeling of dislocation propensity in total hip arthroplasty”, 42nd Annual meeting, Orthopaedic Research society, p. 259-64, Atlanta, Ga. (Feb. 19-22, 1996).
An equally important concern in evaluating the dislocation propensity of an implant is variations in individual anatomies. As a result of anatomical variations, there is no single optimal design and orientation of hip replacement components and surgical procedure to minimize the dislocation propensity of the implant. For example, the pelvis can assume different positions and orientations depending on whether an individual is lying supine (as during a CT-scan or routine X-rays), in the lateral decubitis position (as during surgery) or in critical positions during activities of normal daily living (like bending over to tie shoes or during normal gait). The relative position of the pelvis and leg when defining a “neutral” plane from which the angles of movement, anteversion, abduction, etc., are calculated will significantly influence the measured amount of motion permitted before impingement and dislocation occurs. Therefore, it is necessary to uniquely define both the neutral orientation of the femur relative to the pelvis for relevant positions and activities, and the relationship of the femur with respect to the pelvis of the patient during each segment of leg motion.
Currently, most planning for acetabular implant placement and size selection is performed using acetate templates and a single anterior-posterior x-ray of the pelvis. Acetabular templating is most useful for determining the approximate size of the acetabular component; however, it is only of limited utility for positioning of the implant because the x-rays provide only a two dimensional image of the pelvis. Also, the variations in pelvic orientation cannot be more fully considered as discussed above.
Intra-operative positioning devices currently used by surgeons attempt to align the acetabular component with respect to the sagittal and coronal planes of the patient. B. F. Money, editor, “Reconstructive Surgery of the Joints”, chapter Joint Replacement Arthroplasty, pages 605-608, Churchill Livingston, 1996. These devices assume that the patient's pelvis and trunk are aligned in a known orientation, and do not take into account individual variations in a patient's anatomy or pelvic position on the operating room table. These types of positioners can lead to a wide discrepancy between the desired and actual implant placement, possibly resulting in reduced range of motion, impingement and subsequent dislocation.
Several attempts have been made to more precisely prepare the acetabular region for the implant components. U.S. Pat. No. 5,007,936 issued to Woolson is directed to establishing a reference plane through which the acetabulum can be reamed and generally prepared to receive the acetabular cup implant. The method provides for establishing the reference plane based on selecting three reference points, preferably the 12 o'clock position on the superior rim of the acetabulum and two other reference points, such as a point in the posterior rim and the inner wall, which are known distances from the superior rim. The location of the superior rim is determined by performing a series of computed tomography (CT) scans that are concentrated near the superior rim and other reference locations in the acetabular region.
In the Woolson method, calculations are then performed to determine a plane in which the rim of the acetabular cup should be positioned to allow for a predetermined rotation of the femoral head in the cup. The distances between the points and the plane are calculated and an orientation jig is calibrated to define the plane when the jig is mounted on the reference points. During the surgical procedure, the surgeon must identify the 12 o'clock orientation of the superior rim and the reference points. In the preferred mode, the jig is fixed to the acetabulum by drilling a hole through the reference point on the inner wall of the acetabulum and affixing the jig to the acetabulum. The jig incorporates a drill guide to provide for reaming of the acetabulum in the selected plane.
A number of difficulties exist with the Woolson method. For example, the preferred method requires drilling a hole in the acetabulum. Also, visual recognition of the reference points must be required and precision placement of the jig on reference points is performed in a surgical setting. In addition, proper alignment of the reaming device does not ensure that the implant will be properly positioned, thereby establishing a more lengthy and costly procedure with no guarantee of better results. These problems may be a reason why the Woolson method has not gained widespread acceptance in the medical community.
In U.S. Pat. Nos. 5,251,127 and 5,305,203 issued to Raab, a computer-aided surgery apparatus is disclosed in which a reference jig is attached to a double self-indexing screw, previously attached to the patient, to provide for a more consistent alignment of the cutting instruments similar to that of Woolson. However, unlike Woolson, Raab et al. employ a digitizer and a computer to determine and relate the orientation of the reference jig and the patient during surgery with the skeletal shapes determined by tomography.
Similarly, U.S. Pat. Nos. 5,086,401, 5,299,288 and 5,408,409 issued to Glassman et al. disclose an image directed surgical robotic system for reaming a human femur to accept a femoral stem and head implant using a robot cutter system. In the system, at least three locating pins are inserted in the femur and CT scans of the femur in the region containing the locating pins are performed. During the implanting procedure, the locating pins are identified on the patient, as discussed in col. 9, lines 19-68 of Glassman's '401 patent. The location of the pins during the surgery are used by a computer to transform CT scan coordinates into the robot cutter coordinates, which are used to guide the robot cutter during reaming operations.
While the Woolson, Raab and Glassman patents provide methods and apparatuses that further offer the potential for increased accuracy and consistency in the preparation of the acetabular region to receive implant components, none of these references provide minimally invasive assistance during the implant procedure.
In addition, both the Raab and Glassman methods and apparatuses require that fiducial markers be attached to the patient prior to performing tomography of the patients. Following the tomography, the markers must either remain attached to the patient until the surgical procedure is performed or the markers must be reattached at the precise locations to allow the transformation of the tomographic data to the robotic coordinate system, either of which is undesirable and/or difficult in practice.
Thus, in addition to a continued need to provide improved systems and methods to provide proper placement plans and joint preparation techniques to ensure optimal outcomes in terms of range of motion and usage, there exists a need for improved intra-operative implant placement systems and methods.
SUMMARYAn implant positioning device is described. The positioning device includes an end effector configured to contact an implant component during a surgical procedure, the end effector operably connected to at least one actuator for imparting an impact force to the implant component during the surgical procedure, a motor mechanically connected to the at least one actuator and configured to move the at least one actuator to produce one or more impacts on the end effector, thereby imparting the impact force to the implant component, and a control circuit coupled to the motor. The control circuit is configured to generate at least one motor control signal, transfer the at least one motor control signal to the motor, and as a result of the at least one motor control signal, cause the motor to move the at least one actuator to produce one or more impacts on the end effector.
A method for inserting an implant component during a surgical procedure using an implant positioning device is also described. The method includes generating, at a control circuit, at least one motor control signal; receiving, at a motor operably connected to the control circuit, the at least one motor control signal; moving, by the motor, at least one actuator mechanically connected to the motor as a result of the at least one motor control signal; and imparting, by an end effector coupled to the at least one actuator, an impact force to an implant component.
Some embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings in which:
Implant—For the purposes of this specification and the associated claims, the term “implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure a prosthetic acetabular cup (implant) is used to replace or enhance a patients worn or damaged acetabulum. While the term “implant” is generally considered to denote a man-made structure (as contrasted with a transplant), for the purposes of this specification an implant can include a biological tissue or material transplanted to replace or enhance a biological structure.
Implant host—For the purposes of this specification and the associated claims, the term “implant host” is used to refer to a patient. In certain instances the term implant host may also be used to refer, more specifically, to a particular joint or location of the intended implant within a particular patient's anatomy. For example, in a total hip replacement procedure the implant host may refer to the hip joint of the patient being replaced or repaired.
Real-time—For the purposes of this specification and the associated claims, the term “real-time” is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system. However, the use of the term “real-time” is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine.
DETAILED DESCRIPTIONExample systems and methods for providing and using a navigated and computer controlled implant positioning device are described. In some example embodiments, the systems and methods for computer-aided navigation and control of an implant positioning device can involve a computer-controllable powered impactor. In an example, the computer-controllable powered impactor can be used by a surgeon to insert a prosthetic acetabular cup into the acetabulum of an implant host (e.g., a patient). In other examples, an alternative implant positioning device can be used to assist in a similar arthroplasty procedure, such as a total knee replacement. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of example embodiments. It will be evident, however, to one skilled in the art, that the present invention may be practiced without these specific details. It will also be evident that a computer controlled implant positioning system is not limited to the examples provided and may include other scenarios not specifically discussed.
In an example, the discussed system includes an acetabular positioning device outfitted with additional impaction devices. The positioning device can be tracked in at least 2 degrees of rotation by a tracking system connected to a computer. Programs running on a control system can communicate with the tracking system to monitor the orientation and optionally the position of the acetabular implant as the user orients it relative to the patient's body (which is also tracked by the tracking system) in order to achieve an intended preoperative plan, which is stored in the control system's memory. The control system also can include a display that gives the user (e.g., surgeon) information regarding the current position and/or orientation relative to the body position, and/or relative to the preoperative plan. The control system can also communicate with the impaction device(s). A variety of algorithms may be used to calculate which and how impact devices should be activated. The simplest algorithm could be that the impact devices activate when the user aligns the acetabular implant coincident to the preoperative plan. Furthermore, this actuation could be dependent on secondary input from the user, like a trigger, foot pedal signal, or voice command.
The impaction devices may be mounted to the acetabular positioner such that the impactions apply forces or torques to the implant in a known way, and the computer algorithms may use robotic path planning techniques to optimize a sequence of impactions to push the acetabular component in an optimized pattern toward the final preoperative plan.
Additional sensors can be deployed on the positioning tool in order to give feedback on forces and torques applied to the positioning tool, or to measure the force and torque applied to a partially or fully fixed acetabular implant by the positioning device, which could affect the result of the impaction patterns that are employed.
Example SystemThe control system 110 can include one or more computing devices configured to coordinate information received from the tracking system 120 and provide control to the implant positioning device 130. In an example, the control system 110 can include a planning module 112, a navigation module 114, a control module 116, and a communication interface 118. The planning module 112 can provide pre-operative planning services that allow clinicians the ability to virtually plan a procedure prior to entering the operating room. The background discusses a variety of pre-operative planning procedures used in total hip replacement (total hip arthroplasty (THA)) that may be used in surgical robotic assisted joint replacement procedures. Additionally, U.S. Pat. No. 6,205,411 titled “Computer-assisted Surgery Planner and Intra-Operative Guidance System,” to Digioia et al., discusses yet another approach to pre-operative planning U.S. Pat. No. 6,205,411 is hereby incorporated by reference in its entirety.
In an example, such as THA, the planning module 112 can be used to manipulate a virtual model of the implant in reference to a virtual implant host model. The implant host model can be constructed from actual scans of the target patient, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomographic (PET), or ultrasound scanning of the joint and surround structure. Alternatively, the pre-operative planning can be performed by selecting a predefined implant host model from a group of models based on patient measurements or other clinician selected inputs. In certain examples, pre-operative planning is refined intra-operatively by measuring the patient's (target implant host's) actual anatomy. In an example, a point probe connected to the tracking system 120 can be used to measure the target implant host's actual anatomy.
In an example, the navigation module 114 can coordinate tracking the location and orientation of the implant, the implant host, and the implant positioning device 130. In certain examples, the navigation module 114 may also coordinate tracking of the virtual models used during pre-operative planning within the planning module 112. Tracking the virtual models can include operations such as alignment of the virtual models with the implant host through data obtained via the tracking system 120. In these examples, the navigation module 114 receives input from the tracking system 120 regarding the physical location and orientation of the implant positioning device 130 and an implant host. Tracking of the implant host may include tracking multiple individual bone structures. For example, during a total knee replacement procedure the tracking system 120 may individually track the femur and the tibia using tracking devices anchored to the individual bones.
In an example, the control module 116 can process information provided by the navigation module 114 to generate control signals for controlling the implant positioning device 130. In certain examples, the control module 116 can also work with the navigation module 114 to produce visual animations to assist the surgeon during an operative procedure. Visual animations can be displayed via a display device, such as display device 140. In an example, the visual animations can include real-time 3-D representations of the implant, the implant host, and the implant positioning device 130, among other things. In certain examples, the visual animations are color-coded to further assist the surgeon with positioning and orientation of the implant.
In an example, the communication interface 118 facilitates communication between the control system 110 and external systems and devices. The communication interface 118 can include both wired and wireless communication interfaces, such as Ethernet, IEEE 802.11 wireless, or Bluetooth, among others. As illustrated in
In an example, the tracking system 120 provides location and orientation information for surgical devices and parts of an implant host's anatomy to assist in navigation and control of semi-active robotic surgical devices. The tracking system 120 can include a tracker that includes or otherwise provides tracking data based on at least three positions and at least three angles. The tracker can include one or more first tracking markers associated with the implant host, and one or more second markers associated with the surgical device (e.g., an implant positioning device 130). The markers or some of the markers can be one or more of infrared sources, Radio Frequency (RF) sources, ultrasound sources, and/or transmitters. The tracking system 120 can thus be an infrared tracking system, an optical tracking system, an ultrasound tracking system, an inertial tracking system, a wired system, and/or a RF tracking system. One illustrative tracking system can be the OPTOTRAK® 3-D motion and position measurement and tracking system described herein, although those of ordinary skill in the art will recognize that other tracking systems of other accuracies and/or resolutions can be used.
U.S. Pat. No. 6,757,582, titled “Methods and Systems to Control a Shaping Tool,” to Brisson et al., provides additional detail regarding the use of tracking systems, such as tracking system 120, within a surgical environment. U.S. Pat. No. 6,757,582 (the '582 patent) is hereby incorporated by reference in it's entirely.
In an example, a surgeon can use the implant positioning device 130 to assist in inserting an implant within an implant host during a surgical procedure. For example, within THA a surgeon will often insert a prosthetic acetabular cup into the implant host's acetabulum. Inserting a prosthetic acetabular cup often involves a manual or powered impaction device. When a manual impactor is used, the surgeon will hammer on the end of the impactor with a mallet to seat the artificial acetabular cup (e.g., implant) into the proper position. While some manual impaction devices have been coupled with tracking systems, such as tracking system 120, the assistance provided to the surgeon is limited to alignment of the manual impaction device. The systems currently available lack the ability to provide navigated control of an impaction device to assist the surgeon in getting the implant into the ideal implant location (as determined via pre-operative and intra-operative planning) Additional details on an example navigated implant positioning device, such as implant positioning device 130, are provided below in reference to
In an example, the tracking markers 160, 162, and 164 can be used by the tracking system 120 to track location and orientation of the implant host 10, the implant positioning device 130, and a reference, such as an operating table (tracking marker 164). In this example, the tracking system 120 uses optical tracking to monitor the location and orientation of tracking markers 160, 162, and 164. Each of the tracking markers 160, 162, and 164) includes three or more tracking spheres that provide easily processed targets to determine location and orientation in up to six degrees of freedom. The tracking system 120 can be calibrated to provide a localized 3-D coordinate system within which the implant host 10 and the implant positioning device 130 (and by reference the implant) can be spatially tracked. For example, as long as the tracking system 120 can image three of the tracking spheres on a tracking marker, such as tracking marker 160, the tracking system 120 can utilize image processing algorithms to generate points within the 3-D coordinate system. Subsequently, the tracking system 120 (or the navigation module 114 (
Operations and capabilities of the systems 100 (
In an example, the method 300 can optionally begin at 305 with the planning module 112 (
At 310, the method 300 can continue with the control system 110 (
At 315, the method 300 can optionally continue with the control system 110, via the communication interface 118, initializing a communication link with the implant positioning device 130 and/or the tracking system 120 (
At 320, the method 300 can continue with the control system 110 establishing a 3-D coordinate system to track the surgical instruments and implant host 10 (
At 330, the method 300 can continue with the control system 110 receiving tracking information from the tracking system 120 (
In an example, at 335, the method 300 can continue with the navigation module 114 (
At 340, the method 300 can continue with the control system 110 determining whether the implant has reached the planned (e.g., ideal) location in reference to the implant host 10 (
At 350, the method 300 continues with the control module 116 transmitting, over the communication interface 118, the control signals to the implant positioning device 130 (
At 355, the method can optionally continue with the control system 110 (
As noted above, the method 300 can loop through operations 330-355 until it is determined, at operation 340, that the implant has reached the ideal location and orientation. In an example, the method 300 can also be halted or paused by a clinician during the implant procedure. If paused, the control system 110 (
The following methods provide additional detail regarding operations introduced above in reference to
The method 320 can begin at operation 410 with the control system 110 and the tracking system 120 (
At 420, the method 320 can continue with the control system 110 facilitating registration of the implant host 10 with the tracking system 120 (
At 430, the method 320 can continue with the control system 110 and/or tracking system 120 facilitating registration of the implant positioning device 130 within the 3-D coordinate system established by the tracking system 120 (
At 440, the method 320 can continue with the control system 110 aligning a virtual implant host model with the implant host 10 (
At 450, the method 320 can continue with the control system 110 aligning a virtual implant model with the implant host 10 (
In this example, the method 345 can begin at 510 with the control module 116 (
At 530, the method 345 can continue with the control module 116 (
In certain examples, the implant positioning device 130 (
At 550, the method 345 can continue with the control module 116 determining orientation parameters to be sent to the implant positioning device 130 (
Finally, at 560, the method 345 can conclude with the control module 116 (
In an example, the method 350 can begin at 610 with the navigation module 114 determining location and orientation of the implant positioning device 130 (
At 620, the method 350 can continue with the control system 110 generating 3-D representations of components such as the implant and the implant positioning device 130 as well as the implant host 10 (
At 625, the method 350 can continue with the control system 110 displaying 3-D representations on a display device, such as display device 140 (
At 645, the method 350 can continue with the control system 110 (
In this example, the primary components of the implant positioning device 130 include a main body 705, a handle 710, a battery (e.g., power supply) 715, a chuck 720, and a trigger 750. The main body 705 contains a motor and other control circuitry required to produce the desired impacts on the end effector 740. The chuck 720 can be configured to allow for inter-changeable positioning arms, such as telescoping positioning arm 730. In certain examples, the trigger 750 provides a manual override allowing the clinician to control the implantation process even while the implant positioning device 130 is receiving control signals from the control system 110.
In this example, the implant positioning device 130 includes a telescoping positioning arm 730. The telescoping positioning arm 730 includes a proximal fixed portion 732 and a distal moveable portion 734. In some examples, a stabilizing handle 735 can be affixed to the proximal fixed portion 732 of the telescoping positioning arm 730. The distal moveable portion 734 includes an end effector 740 affixed to the distal end. The end effector 740 can be configured to mate with an implant to reduce any potential damage to the implant during insertion. The end effector 740 can include a retention device 745 that can be configured to retain the implant in a fixed position relative to the end effector 740 during insertion.
The implant positioning device 130 can include a tracking marker 760 that allows the location and orientation of the implant positioning device 130 to be tracked by the tracking system 120 (
In this example, the implant positioning device 130 can include a manual impact surface 770. The manual impact surface 770 enables a surgeon to revert to manual impaction in situations where the computer-aided navigation and control is not functioning properly.
Finally, the implant positioning device 130 can include a communication link 780. In this example, the communication link 780 is illustrated as a wired connection. However, in other examples, the communication link 780 can be implemented over any suitable wireless protocol, such as IEEE 802.11 or Bluetooth, among others.
Certain embodiments of the computer systems described herein may include logic or a number of components, modules, or mechanisms. Modules may constitute either software modules (e.g., code embodied on a machine-readable medium or in a transmission signal) or hardware modules. A hardware module is a tangible unit capable of performing certain operations and may be configured or arranged in a certain manner. In example embodiments, one or more computer systems (e.g., a standalone, client or server computer system) or one or more hardware modules of a computer system (e.g., a processor or a group of processors) may be configured by software (e.g., an application or application portion) as a hardware module that operates to perform certain operations as described herein.
In various embodiments, a hardware module may be implemented mechanically or electronically. For example, a hardware module may comprise dedicated circuitry or logic that is permanently configured (e.g., as a special-purpose processor, such as a field programmable gate array (FPGA) or an application-specific integrated circuit (ASIC)) to perform certain operations. A hardware module may also comprise programmable logic or circuitry (e.g., as encompassed within a general-purpose processor or other programmable processor) that is temporarily configured by software to perform certain operations. It will be appreciated that the decision to implement a hardware module mechanically, in dedicated and permanently configured circuitry, or in temporarily configured circuitry (e.g., configured by software) may be driven by cost and time considerations.
Accordingly, the term “hardware module” should be understood to encompass a tangible entity, be that an entity that is physically constructed, permanently configured (e.g., hardwired) or temporarily configured (e.g., programmed) to operate in a certain manner and/or to perform certain operations described herein. Considering embodiments in which hardware modules are temporarily configured (e.g., programmed), each of the hardware modules need not be configured or instantiated at any one instance in time. For example, where the hardware modules comprise a general-purpose processor configured using software, the general-purpose processor may be configured as respective different hardware modules at different times. Software may accordingly configure a processor, for example, to constitute a particular hardware module at one instance of time and to constitute a different hardware module at a different instance of time.
Hardware modules can provide information to, and receive information from, other hardware modules. Accordingly, the described hardware modules may be regarded as being communicatively coupled. Where multiple such hardware modules exist contemporaneously, communications may be achieved through signal transmission (e.g., over appropriate circuits and buses) that connect the hardware modules. In embodiments in which multiple hardware modules are configured or instantiated at different times, communications between such hardware modules may be achieved, for example, through the storage and retrieval of information in memory structures to which the multiple hardware modules have access. For example, one hardware module may perform an operation and store the output of that operation in a memory device to which it is communicatively coupled. A further hardware module may then, at a later time, access the memory device to retrieve and process the stored output. Hardware modules may also initiate communications with input or output devices, and can operate on a resource (e.g., a collection of information).
The various operations of example methods described herein may be performed, at least partially, by one or more processors that are temporarily configured (e.g., by software) or permanently configured to perform the relevant operations. Whether temporarily or permanently configured, such processors may constitute processor-implemented modules that operate to perform one or more operations or functions. The modules referred to herein may, in some example embodiments, comprise processor-implemented modules.
Similarly, the methods described herein may be at least partially processor-implemented. For example, at least some of the operations of a method may be performed by one or processors or processor-implemented modules. The performance of certain of the operations may be distributed among the one or more processors, not only residing within a single machine, but deployed across a number of machines. In some example embodiments, the processor or processors may be located in a single location (e.g., within a home environment, an office environment or as a server farm), while in other embodiments the processors may be distributed across a number of locations.
The one or more processors may also operate to support performance of the relevant operations in a “cloud computing” environment or as a “software as a service” (SaaS). For example, at least some of the operations may be performed by a group of computers (as examples of machines including processors), with these operations being accessible via a network (e.g., the Internet) and via one or more appropriate interfaces (e.g., APIs).
Electronic Apparatus and SystemExample embodiments may be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them. Example embodiments may be implemented using a computer program product, for example, a computer program tangibly embodied in an information carrier, for example, in a machine-readable medium for execution by, or to control the operation of, data processing apparatus, for example, a programmable processor, a computer, or multiple computers. Certain example embodiments of an implant positioning device 130 (
A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, subroutine, or other unit suitable for use in a computing environment. A computer program can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by a communication network.
In example embodiments, operations may be performed by one or more programmable processors executing a computer program to perform functions by operating on input data and generating output. Method operations can also be performed by, and apparatus of example embodiments may be implemented as, special purpose logic circuitry (e.g., a FPGA or an ASIC).
The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In embodiments deploying a programmable computing system, it will be appreciated that both hardware and software architectures require consideration. Specifically, it will be appreciated that the choice of whether to implement certain functionality in permanently configured hardware (e.g., an ASIC), in temporarily configured hardware (e.g., a combination of software and a programmable processor), or a combination of permanently and temporarily configured hardware may be a design choice. Below are set out hardware (e.g., machine) and software architectures that may be deployed, in various example embodiments.
Example Machine Architecture and Machine-Readable MediumThe example computer system 1100 includes a processor 1102 (e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both), a main memory 1104 and a static memory 1106, which communicate with each other via a bus 1108. The computer system 1100 may further include a video display unit 1110 (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)). The computer system 1100 also includes an alphanumeric input device 1112 (e.g., a keyboard), a user interface (UI) navigation device (or cursor control device) 1114 (e.g., a mouse), a disk drive unit 1116, a signal generation device 1118 (e.g., a speaker) and a network interface device 1120.
Machine-Readable MediumThe disk drive unit 1116 includes a machine-readable medium 1122 on which is stored one or more sets of instructions and data structures (e.g., software) 1124 embodying or used by any one or more of the methodologies or functions described herein. The instructions 1124 may also reside, completely or at least partially, within the main memory 1104, static memory 1106, and/or within the processor 1102 during execution thereof by the computer system 1100, the main memory 1104 and the processor 1102 also constituting machine-readable media.
While the machine-readable medium 1122 is shown in an example embodiment to be a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more instructions or data structures. The term “machine-readable medium” shall also be taken to include any tangible medium that is capable of storing, encoding or carrying instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the present invention, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. The term “machine-readable medium” shall accordingly be taken to include, but not be limited to, solid-state memories, and optical and magnetic media. Specific examples of machine-readable media include non-volatile memory, including by way of example, semiconductor memory devices (e.g., erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. A “machine-readable storage medium” shall also include devices that may be interpreted as transitory, such as register memory, processor cache, and RAM, among others. The definitions provided herein of machine-readable medium and machine-readable storage medium are applicable even if the machine-readable medium is further characterized as being “non-transitory.” For example, any addition of “non-transitory,” such as non-transitory machine-readable storage medium, is intended to continue to encompass register memory, processor cache and RAM, among other memory devices.
Transmission MediumThe instructions 1124 may further be transmitted or received over a communications network 1126 using a transmission medium. The instructions 1124 may be transmitted using the network interface device 1120 and any one of a number of well-known transfer protocols (e.g., HTTP). Examples of communication networks include a LAN, a WAN, the Internet, mobile telephone networks, plain old telephone (POTS) networks, and wireless data networks (e.g., WiFi and WiMax networks). The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine, and includes digital or analog communications signals or other intangible media to facilitate communication of such software.
Thus, methods and systems for navigation and control of an implant positioning device have been described. Although the present invention has been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense.
Although an embodiment has been described with reference to specific example embodiments, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be used and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. This Detailed Description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.
Such embodiments of the inventive subject matter may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept if more than one is in fact disclosed. Thus, although specific embodiments or examples have been illustrated and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended; that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” “third,” and so forth are used merely as labels, and are not intended to impose numerical requirements on their objects.
The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b), requiring an abstract that will allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.
Claims
1-19. (canceled)
20. An implant positioning system, comprising:
- an implant positioning device comprising one or more actuators and a positioning arm having a proximal fixed portion and a distal moveable portion coupled to an end effector;
- a tracking device configured to identify a first location of a first tracking marker attached to anatomy of an implant host and a second location of a second tracking marker attached to the implant positioning device; and
- a control device coupled to the tracking device via a communication interface and comprising one or more processors coupled to a memory, the memory including instructions that, when executed by the one or more processors, cause the control device to: obtain an implant plan for positioning a prosthetic acetabular cup attached to the end effector into an acetabulum of the implant host, wherein the implant plan comprises a virtual implant host model and a planned location and orientation of the prosthetic acetabular cup within the implant host, register the implant host and the implant positioning device within a coordinate system based on the identified first and second locations, align the virtual implant host model with the registered implant host, generate a visualization based on the registration and alignment, wherein the visualization comprises the virtual implant host model, an indication of the planned location and orientation, and a representation of the prosthetic acetabular cup, wherein the representation of the prosthetic acetabular cup is located in the visualization based on the identified second location, and output the visualization to a display device to facilitate implantation of the prosthetic acetabular cup via linear motion imparted by the one or more actuators on the distal moveable portion or the end effector.
21. The implant positioning system of claim 20, wherein the visualization further comprises a cross-hair alignment guide and the one or more processors are further configured to execute the instructions to cause the control device to generate the cross-hair alignment guide based on one or more of a current location of the prosthetic acetabular cup, the planned location and orientation, a location and orientation of the implant positioning device, or a location and orientation of the implant host.
22. The implant positioning system of claim 20, wherein the visualization further comprises a three-dimensional representation of the implant host, the implant positioning device, and the prosthetic acetabular cup, wherein the three-dimensional representation provides real-time feedback to assist with alignment of the prosthetic acetabular cup with the implant host.
23. The implant positioning system of claim 20, wherein the control device is coupled to the implant positioning device via another communication interface, wherein the implant positioning device further comprises control circuitry electrically connected to the one or more actuators, and wherein the one or more processors are further configured to execute the instructions to cause the control device to:
- determine that the planned location and orientation has not been reached based on the identified first and second locations, and
- transmit one or more control signals to the control circuitry to move one or more of the one or more actuators to thereby induce a movement of the prosthetic acetabular cup.
24. The implant positioning system of claim 23, wherein the one or more of the control signals further comprise an impact frequency or an impact amplitude and the one or more processors are further configured to execute the instructions to cause the control device to generate the one or more control signals based on the identified first and second locations and the planned location and orientation.
25. The implant positioning system of claim 23, wherein the one or more actuators comprise a plurality of actuators coupled to the:
- distal moveable portion and the end effector; or
- the distal moveable portion and the proximal fixed portion.
26. The implant positioning system of claim 25, wherein the one or more control signals are further configured to cause the control circuitry to move one or more of the plurality of actuators to impart one or more impact forces to induce, during insertion, a rotational motion on the prosthetic acetabular cup.
27. The implant positioning system of claim 23, wherein the proximal fixed portion and the distal moveable portion collectively comprise a telescoping arm and wherein the one or more control signals are further configured to control extension of the telescoping arm.
28. An implant positioning system, comprising:
- an implant positioning device comprising: a positioning arm having a proximal fixed portion and a distal moveable portion coupled to an end effector, and control circuitry electrically connected to one or more actuators;
- a tracking device configured to identify a first location of a first tracking marker attached to anatomy of an implant host and a second location of a second tracking marker attached to the implant positioning device; and
- a control device coupled to the implant positioning device and the tracking device via one or more communication interfaces and comprising one or more processors coupled to a memory, the memory including instructions that, when executed by the one or more processors, cause the control device to: obtain an implant plan for positioning a prosthetic acetabular cup attached to the end effector into an acetabulum of the implant host, wherein the implant plan comprises a planned location and orientation of the prosthetic acetabular cup within the implant host, receive the first and second locations from the tracking device, determine that the planned location and orientation of the prosthetic acetabular cup has not been reached based on the received first and second locations, and transmit one or more control signals to the control circuitry to move the one or more actuators to thereby induce a movement of the prosthetic acetabular cup toward the planned location and orientation.
29. The implant positioning system of claim 28, wherein the one or more control signals comprise an impact frequency or an impact amplitude and the one or more processors are further configured to execute the instructions to cause the control device to generate the one or more control signals based on the received first and second locations and the planned location and orientation.
30. The implant positioning system of claim 28, wherein the one or more actuators comprise a plurality of actuators coupled to the:
- distal moveable portion and the end effector; or
- the distal moveable portion and the proximal fixed portion.
31. The implant positioning system of claim 30, wherein the one or more control signals are configured to cause the control circuitry to move one or more of the plurality of actuators to impart one or more impact forces to induce, during insertion, a rotational motion on the prosthetic acetabular cup.
32. The implant positioning system of claim 28, wherein the proximal fixed portion and the distal moveable portion collectively comprise a telescoping arm and wherein the one or more control signals are configured to control extension of the telescoping arm.
33. The implant positioning system of claim 28, wherein the obtained implant plan further comprises a virtual implant host model and wherein the one or more processors are further configured to execute the instructions to cause the control device to:
- register the implant host and the implant positioning device within a coordinate system based on the first and second locations,
- align the virtual implant host model with the registered implant host,
- generate a visualization based on the registration and alignment, wherein the visualization comprises the virtual implant host model, an indication of the planned location and orientation, and a representation of the prosthetic acetabular cup, wherein the representation of the prosthetic acetabular cup is located in the visualization based on the second location, and
- output the visualization to a display device to facilitate implantation of the prosthetic acetabular cup.
34. The implant positioning system of claim 33, wherein the visualization further comprises a cross-hair alignment guide and the one or more processors are further configured to execute the instructions to cause the control device to generate the cross-hair alignment guide based on one or more of a current location of the prosthetic acetabular cup, the planned location and orientation, a location and orientation of the implant positioning device, or a location and orientation of the implant host.
35. The implant positioning system of claim 33, wherein the visualization further comprises a three-dimensional representation of the implant host, the implant positioning device, and the prosthetic acetabular cup, wherein the three-dimensional representation provides real-time feedback to assist with alignment of the prosthetic acetabular cup with the implant host.
36. An implant positioning system, comprising:
- an implant positioning device comprising: a positioning arm having a proximal fixed portion and a distal moveable portion coupled to an end effector, and control circuitry electrically connected to one or more actuators;
- a tracking device configured to track a first location of an implant host and a second location of the implant positioning device; and
- a control device coupled to the implant positioning device and the tracking device via one or more communication interfaces and comprising one or more processors coupled to a memory, the memory including instructions that, when executed by the one or more processors, cause the control device to: obtain an implant plan for positioning a prosthetic acetabular cup attached to the end effector into an acetabulum of the implant host, wherein the implant plan comprises a planned location and orientation of the prosthetic acetabular cup within the implant host, receive the tracked first and second locations from the tracking device, generate one or more control signals comprising an impact frequency or an impact amplitude based on the tracked first and second locations and the planned location and orientation, and transmit the one or more control signals to the control circuitry to move the one or more actuators to thereby induce a movement of the prosthetic acetabular cup.
37. The implant positioning system of claim 36, wherein the one or more processors are further configured to execute the instructions to cause the control device to determine prior to generating the one or more control signals that the planned location and orientation of the prosthetic acetabular cup has not been reached based on the tracked first and second locations.
38. The implant positioning system of claim 36, wherein the one or more actuators comprise a plurality of actuators coupled to the:
- distal moveable portion and the end effector; or
- the distal moveable portion and the proximal fixed portion.
39. The implant positioning system of claim 38, wherein the one or more control signals are configured to cause the control circuitry to move one or more of the plurality of actuators to impart one or more impact forces to induce, during insertion, a rotational motion on the prosthetic acetabular cup.
40. The implant positioning system of claim 36, wherein the proximal fixed portion and the distal moveable portion collectively comprise a telescoping arm and wherein the one or more control signals are configured to control extension of the telescoping arm.
41. The implant positioning system of claim 36, wherein the obtained implant plan further comprises a virtual implant host model and wherein the one or more processors are further configured to execute the instructions to cause the control device to:
- register the implant host and the implant positioning device within a coordinate system based on the first and second locations,
- align the virtual implant host model with the registered implant host,
- generate a visualization based on the registration and alignment, wherein the visualization comprises the virtual implant host model, an indication of the planned location and orientation, and a representation of the prosthetic acetabular cup, wherein the representation of the prosthetic acetabular cup is located in the visualization based on the second location, and
- output the visualization to a display device to facilitate implantation of the prosthetic acetabular cup.
42. The implant positioning system of claim 41, wherein the visualization further comprises a cross-hair alignment guide and the one or more processors are further configured to execute the instructions to cause the control device to generate the cross-hair alignment guide based on one or more of a current location of the prosthetic acetabular cup, the planned location and orientation, a location and orientation of the implant positioning device, or a location and orientation of the implant host.
43. The implant positioning system of claim 41, wherein the visualization further comprises a three-dimensional representation of the implant host, the implant positioning device, and the prosthetic acetabular cup, wherein the three-dimensional representation provides real-time feedback to assist with alignment of the prosthetic acetabular cup with the implant host.
Type: Application
Filed: Jan 21, 2022
Publication Date: Jul 7, 2022
Inventors: Constantinos NIKOU (Monroeville, PA), Branislav JARAMAZ (Pittsburgh, PA), Benjamin Oliver MCCANDLESS (Pittsburgh, PA)
Application Number: 17/581,488