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Patient-matched surgical component and methods of use

Patient-matched surgical component and methods of use description/claims

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/944,817, filed Jun. 19, 2007, the complete disclosure of which is expressly incorporated herein by this reference.

The present teachings relate generally to surgical navigation, and more particularly to patient-matched surgical components that are adapted to conform to a patient's anatomy, as well as to methods for using such surgical components during a surgical navigation procedure.

Surgical navigation systems, also known as computer assisted surgery systems and image guided surgery systems, aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation has been compared to a global positioning system that aids vehicle operators to navigate the earth. A surgical navigation system typically includes a computer, a tracking system, and patient anatomical information. The patient anatomical information can be obtained by using an imaging mode such as fluoroscopy, magnetic resonance imaging (MRI), computer tomography (CT) or by simply defining the location of patient anatomy with the surgical navigation system. Surgical navigation systems can be used for a wide variety of surgeries to improve patient outcomes.

To successfully implant a medical device, surgical navigation systems often employ various forms of computing technology, as well as utilize intelligent instruments, digital touch devices, and advanced 3-D visualization software programs. All of these components enable surgeons to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to a patient's body, as well as conduct preoperative and intra-operative body imaging.

To accomplish the accurate planning, tracking and navigation of surgical instruments, tools and/or medical devices during a surgical procedure utilizing surgical navigation, surgeons often couple “tracking arrays” to the surgical components. These tracking arrays allow the surgeons to track the physical location of these surgical components, as well as the patient's bones during the surgery. By knowing the physical location of the tracking array, software associated with the tracking system can accurately calculate the position of the tracked component relative to a surgical plan image.

It is known to use surgical navigation instruments to measure the size and general contour of a bone before selecting and/or manufacturing a prosthetic implant. This process allows the surgeon to choose a prosthetic component that generally resembles the shape and size of the patient's anatomy, thereby achieving a more customized fit during the implantation process. Despite such customization efforts, most orthopaedic procedures still require the use of adjustable components or guides during the surgical procedure, particularly as such instruments are needed to fit the prosthetic components to the patient's anatomy. However, this process is time consuming, as well as subject to error during the placement and registration of the surgical components. As such, it would be desirable to improve this process to reduce surgery time and improve prosthetic fit and/or function.

The present teachings provide a patient matched surgical component that is custom manufactured to fit a patient's anatomy in a precise manner. To achieve such customization, the patient's anatomy is preoperatively scanned and uploaded to a software program, which then recreates a three-dimensional model of the patient's anatomy from the scanned image. The three-dimensional model is then used by the software program to identify and locate on the image specific known anatomical landmarks of the patient's anatomy. Planning software then analyzes the identified anatomical landmarks together with any specific surgical instructions needed to develop and plan a surgical protocol for the patient. Once the surgical protocol has been approved by the surgeon, the protocol is presented to a software program, which then uses the protocol, as well as the preoperative scan images, to create a virtual patient matched surgical component. The virtual component is then sent to a rapid prototyping machine or a standard machining process, which in turn manufactures the surgical component for use during the surgical procedure. Because the surgical component is custom manufactured to fit the patient's anatomy relative to specific anatomical landmarks, it can be manufactured with a reference array positioned on its surface in a predefined spatial relationship with respect to the patient's anatomy. By having a predefined spatial relationship between the reference array and the patient's anatomy, the need for intra-operative registration during the surgical procedure is minimized or even eliminated altogether. Furthermore, since the patient matched component is fixable to the patient's anatomy with pins, the reference array can act as an automatically registered rigid bone reference marker that can be used throughout the surgical navigation procedure.

According to one aspect of the present teachings, a method of automatically registering a surgical navigation system to a patient's anatomy is provided. The method comprises programming a surgical navigation system with a first spatial relationship between a surgical component and a reference array connected to the surgical component, programming the surgical navigation system with a second spatial relationship between an anatomical feature of a patient and the surgical component, installing the surgical component on the patient such that the surgical component engages the anatomical feature in the second spatial relationship, and locating the reference array with the surgical navigation system. The navigation system automatically recognizes the position of the reference array relative to the patient's anatomy.

According to another exemplary embodiment herein, a method of performing a surgical procedure aided by a surgical navigation system is provided. The method comprises generating a representative model of an anatomical feature from an image of a patient's anatomy, using the model to make a surgical component, installing the surgical component on the anatomical feature by mating the surface of the component with the anatomical feature in the predefined spatial relationship, and tracking movement of the anatomical feature with a tracking system when the installed surgical component is moved within a measurement field of the tracking system. According to this embodiment, the surgical component has a surface that is shaped to substantially mate with the anatomical feature in a predefined spatial relationship.

According to yet another exemplary embodiment herein, a patient matched surgical component is provided. The surgical component comprises a body having a surface that is shaped to substantially mate with the shape of an anatomical feature of a patient in a predefined spatial relationship, and a reference array connected to the body, the reference array being trackable by a tracking system when exposed to a measurement field of the tracking system.

In still another exemplary embodiment, a method of performing a surgical procedure aided by a surgical navigation system is provided. According to this exemplary embodiment, the method comprises generating a representative model of an anatomical feature from an image of a patient's anatomy, using the model to make a surgical component, the surgical component having a reference array associated therewith and a surface that is shaped to substantially mate with an anatomical feature in a predefined spatial relationship, installing the surgical component on the anatomical feature by mating the surface of the component with the anatomical feature in the predefined spatial relationship, tracking movement of the anatomical feature with the tracking system when the installed surgical component is moved within a measurement field of the tracking system, removing a portion of the anatomical feature, the removed portion also including a portion of the installed surgical component, and tracking a remaining portion of the anatomical feature with the tracking system, the remaining portion of the anatomical feature including a portion of the installed surgical component, the remaining portion of the installed surgical component including the reference array.

The above-mentioned aspects of the present teachings and the manner of obtaining them will become more apparent and the invention itself will be better understood by reference to the following description of the embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an exemplary operating room setup in a surgical navigation embodiment in accordance with the present teachings;

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