Patent Application
20230414295
The invention in general relates to surgery and in particular to tools for installing a tracking member on a bone.
Tracking systems are commonly used in computer-assisted surgical procedures to track various objects in the operating room (OR). These tracked objects may include surgical devices, instruments, and the patient's anatomy. Examples of tracking systems include optical tracking systems and electromagnetic tracking systems. Optical tracking systems generally include a tracking computer that receives data from two or more optical sensors (e.g., cameras) to detect the POSE of three or more fiducial markers (e.g., active markers (e.g., LEDs), passive markers (e.g., retroreflective spheres)) coupled to the tracked object. Three or more fiducial markers arranged in a known geometry may be referred to herein as a tracking array. The optical tracking system is capable of defining a tracking array coordinate system and track movement of the object in six degrees-of-freedom (6-DoF). Electromagnetics tracking systems generally include an electromagnetic field generator for detecting the POSE of electromagnetic sensors coupled to the tracked object, which also enables 6-DoF tracking.
A particular computer-assisted surgical procedure that may utilize an optical tracking system is total knee arthroplasty (TKA). In TKA, the worn articular surfaces of the femur and tibia are removed and replaced with implants to restore the function of the knee so as to alleviate discomfort associated with the worn joint. A TKA begins with the generation of a surgical plan defining one or more locations for a surgical device to perform an action (e.g., removing bone, inserting pins) on the femur and tibia. A femoral tracking array is installed on the femur and the surgical plan is registered to the femur with respect to the coordinate system of the femoral tracking array. A tibial tracking array is installed on the tibia and the surgical plan is registered to the tibia with respect to the coordinate system of the tibial tracking array. This allows the optical tracking system to track movement of the femur and tibia and their respective surgical plans to accurately execute the surgical plan with the surgical device.
Installing a tracking array on a bone generally includes the following. A user identifies a location to install the tracking array on the bone that will not interfere with the removal of the bone or the operation of a surgical device or any other instruments during the procedure. Two fixation elements (e.g., pins, screws) are inserted into the bone at the identified location with the aid of an alignment guide, and a bracket is then fixed onto the fixation elements. The alignment guide includes two guide holes for guiding the fixation elements into the bone, where the guides holes are spaced a distance apart corresponding to a distance between two receiving elements (e.g., holes) of the bracket. After the fixation elements are inserted in the bone, the alignment guide is removed from the bone and discarded. The tracking array is then fixed onto the bracket.
Several problems are associated with this process. First, multiple tools (i.e., alignment guide and bracket) are required to install the tracking array in the bone. This increases the cost of the procedure and increases the overall surgical time. Second, the final location of the tracking array when fixed to the bracket may be sub-optimal (e.g., sub-optimal line-of-sight to the optical detectors, a location which may interfere with the operation of a surgical device). This may require the user to re-insert the fixation elements at a new location on the bone, which requires additional time and additional holes drilled in the bone. Additionally, conventional brackets may have insufficient fixation mechanisms that can cause the bracket to move relative to the fixation elements, or the tracking array to move relative to the bracket. Any movement of the tracking array relative to the bone after registration causes a corresponding movement of the surgical plan relative to the bone, in which event the surgical plan needs to be re-registered to the bone/tracking array before the procedure can resume.
Thus, there exists a need for an installation tool for a tracking member that overcomes the aforementioned limitations.
An installation tool for installing a tracking member on a substrate is provided that includes a body with at least one guide hole located at a first end of the body for guiding a fixation element into the substrate. A holding mechanism is provided for holding the body to the fixation element. A coupler located at an opposing end of the body is provided for coupling the tracking member to the body. A removable handle has an opening for receiving at least portion of the coupler inside the removable handle.
A system is also provided that includes the installation tool and a tracking member.
The present invention is further detailed with respect to the following drawings that are intended to show certain aspects of the present of invention, but should not be construed as limit on the practice of the invention, wherein:
The present invention has utility as a tool and system to efficiently install a tracking array in a substrate. This is especially beneficial during a computer-assisted surgical procedure that utilizes a tracking system. The present invention will now be described with reference to the following embodiments. As is apparent by these descriptions, this invention can be embodied in different forms and should not be construed as limited to the embodiments set forth herein. For example, features illustrated with respect to one embodiment can be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from the embodiment. In addition, numerous variations and additions to the embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the instant invention. Hence, the following specification is intended to illustrate some particular embodiments of the invention, and not to exhaustively specify all permutations, combinations, and variations thereof.
Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference in their entirety.
It is to be understood that in instances where a range of values are provided that the range is intended to encompass not only the end point values of the range but also intermediate values of the range as explicitly being included within the range and varying by the last significant figure of the range. By way of example, a recited range of from 1 to 4 is intended to include 1-2, 1-3, 2-4, 3-4, and 1-4.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
Unless indicated otherwise, explicitly or by context, the following terms are used herein as set forth below.
As used in the description of the invention and the appended claims, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
Also as used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations when interpreted in the alternative (“or”).
As used herein, the terms “computer-assisted surgical device” and “CAS device” refer to devices used in surgical procedures that are at least in part assisted by one or more computers. Examples of CAS devices illustratively include tracked/navigated instruments and surgical robots. Examples of a surgical robot illustratively include robotic hand-held devices, serial-chain robots, bone mounted robots, parallel robots, or master-slave robots, as described in U.S. Pat. Nos. 6,757,582; 7,206,626; 8,876,830; and 8,961,536; U.S. Patent Publication No. 2013/0060278; and PCT Patent Publication Nos.: PCT/US2021/031703; and PCT/US2020/062686; which patents and patent application are incorporated herein by reference. The surgical robot may be active (e.g., automatic/autonomous control), semi-active (e.g. a combination of automatic and manual control), haptic (e.g., tactile, force, and/or auditory feedback), and/or provide power control (e.g., turning a robot or a part thereof on and off). The terms “computer-assisted surgical system” and “CAS system” refer to systems utilizing a computer or software to assist in planning a position for one or more bone cuts to be formed on a bone for mounting contact surfaces of an implant thereon, and/or systems that assist in forming one or more bone cuts on a bone. An example of a CAS system may include: i) a CAS device and software used by the CAS device (e.g., cutting instructions); ii) one or more CAS devices (e.g., a surgical robot); and iii) any of the aforementioned with additional devices or software (e.g., a tracking system, tracked/navigated instruments, tracking arrays, bone pins, a rongeur, an oscillating saw, a rotary drill, manual cutting guides, manual cutting blocks, manual cutting jigs, etc.).
Embodiments of the present invention describe a tool and system to efficiently install a tracking member in a substrate. Surgical substrates that commonly require installation of a tracking array include bones and implants. While the present invention is further detailed with respect to a TKA procedure in the accompanying drawings, it is to be understood that the present invention is applicable to computer-assisted surgical procedures in general and regardless of anatomy, as well as manufacturing processes. Examples of such surgical procedures include total and partial joint replacement (e.g., hip, shoulder, ankle, and knee joints); unicompartmental arthroplasty; bone fracture repair; osteotomies; craniotomies; spinal reconstruction; and pedicle screw placement. Exemplary manufacturing processes that benefit from the present invention include composite material part adhesive bead line application and cutting of composite materials. Composite materials are routinely used in the aerospace, vehicle, and sporting goods manufacturing sectors.
The present invention also affords an additional advantage in allowing a surgeon or a biomechanical engineer to simulate operation of a replaced joint through the relative movement of tracking arrays. As a result, refinements of the TKA can occur through ligament adjustment or soft tissue adjustments.
Referring now to the drawings,
The installation tool 10 provides several advantages relative to conventional tools, these advantages include the fact that the installation tool 10 is an all-in-one tool for installing a tracking member to the bone. The installation tool 10 guides the fixation elements into the bone or other substrate and directly couples to the fixation elements, where a tracking member can be coupled to the body 12 of the installation tool 12 via the coupler 20 upon removal of the removable handle 22. Further, the removable handle 22 provides the user with feedback as to the final location of the tracking member because the location of the user's hand on the removable handle 22 during the installation process can approximate the final location of the tracking array when coupled to the coupler 20. This feedback is depicted in
The body 12 may include a first portion 24 and a second portion 26. The first portion 24 may be angled relative to the second portion 26 to position the tracking member at an optimal view to the tracking system. The first portion 24 may be elongated. The second portion 26 may be part of the holding mechanism 18 and located at the first end of the body 12. The second portion 26 may be substantially planar relative to the first portion 24, with the first portion 24 angled “a” anywhere from 1 to 90 degrees from the second portion 26, but preferably in the range of 20 to 70 degrees. In some inventive embodiments, a lockable hinge 27 is provided to allow the first portion to pivot relative to the second portion 26 to adjust the angle “a”. As a result, a tracking array mounted thereto can be repositioned for reasons that illustratively include alignment with other tracking system components or better access to the surgical field.
The holding mechanism 18 may include a stationary jaw 28 and a movable jaw 30 to clamp the body 12 to the fixation elements inserted in the bone. The movable jaw 30 may be moved relative to the stationary jaw 28 with a tightening element (e.g., by rotating a knob 32 coupled to a screw 34 (as shown in
The guide hole(s) (14, 16) are positioned between the stationary jaw 29 and the movable jaw 30. The guide hole(s) (14, 16) may be bored through a portion of the body 12 such as the second portion 16 of the body 12. Guide tubes (36, 38) may extend beyond the guide holes (14, 16) for further guidance and stabilization of the fixation elements during installation. In other embodiments, the guide tubes (36, 38) having guide holes (14, 16) are coupled to the body 12 (rather than bored through a portion of the body 12), and more particularly coupled to the second portion 26 of the body 12 between the stationary jaw 28 and the movable jaw 30. It should be appreciated that the term “couple” or “coupled” as used herein refers to a connection, an attachment, a link, a join, or an integration of one component to another, either directly or indirectly.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the described embodiments in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient roadmap for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes may be made in the function and arrangement of elements without departing from the scope as set forth in the appended claims and the legal equivalents thereof.
This application is a non-provisional application that claims priority of U.S. Provisional Application Ser. No. 63/354,758 filed Jun. 23, 2022; the contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63354758 | Jun 2022 | US |
