The present invention generally relates to loadable modules usable in a surgical procedure. In particular, the present invention relates to a system and method for the utilization of plug-ins in a surgical workflow.
Medical practitioners, such as doctors, surgeons, and other medical professionals, often rely upon technology when performing a medical procedure, such as image-guided surgery or examination. A tracking system may provide positioning information for the medical instrument with respect to the patient or a reference coordinate system, for example. A medical practitioner may refer to the tracking system to ascertain the position of the medical instrument when the instrument is not within the practitioner's line of sight. A tracking system may also aid in pre-surgical planning.
The tracking or navigation system allows the medical practitioner to visualize the patient's anatomy and track the position and orientation of the instrument. The medical practitioner may use the tracking system to determine when the instrument is positioned in a desired location. The medical practitioner may locate and operate on a desired or injured area while avoiding other structures. Increased precision in locating medical instruments within a patient may provide for a less invasive medical procedure by facilitating improved control over smaller instruments having less impact on the patient. Improved control and precision with smaller, more refined instruments may also reduce risks associated with more invasive procedures such as open surgery.
In medical and surgical imaging, such as intraoperative or perioperative imaging, images are formed of a region of a patient's body. The images are used to aid in an ongoing procedure with a surgical tool or instrument applied to the patient and tracked in relation to a reference coordinate system formed from the images. Image-guided surgery is of a special utility in surgical procedures such as brain surgery and arthroscopic procedures on the knee, wrist, shoulder or spine, as well as certain types of angiography, cardiac procedures, interventional radiology and biopsies in which x-ray images may be taken to display, correct the position of, or otherwise navigate a tool or instrument involved in the procedure.
Several areas of surgery involve very precise planning and control for placement of an elongated probe or other article in tissue or bone that is internal or difficult to view directly. In particular, for brain surgery, stereotactic frames that define an entry point, probe angle and probe depth are used to access a site in the brain, generally in conjunction with previously compiled three-dimensional diagnostic images, such as MRI, PET or CT scan images, which provide accurate tissue images. For placement of pedicle screws in the spine, where visual and fluoroscopic imaging directions may not capture an axial view to center a profile of an insertion path in bone, such systems have also been useful.
Current image-guided surgery or examination systems operate with modules that present a surgical workflow to doctor(s) or surgeon(s) performing a medical surgery, procedure or examination. The modules present relevant information to doctors and surgeons necessary for a successful surgery, procedure or examination. The modules are loaded onto the image display within the doctor or surgeon's view. The modules then provide a series of instructions and guides to assist the doctor or surgeon through the procedure. Typically, the modules consist of a series of images and text.
Current modules are created through a very costly and time-consuming process. For example, a third party vendor may desire to create a new module providing for image guidance during surgery for a new hip implant created and sold by the vendor. The vendor must first meet and confer with the party that creates and provides the image guidance modules. The two parties must establish a project plan for the design, implementation and certification of the image guidance module. Typically, the vendor presents its requirements for the image guidance module for the new hip implant to the module creator. Once the module creator receives the vendor's requirements, the module creator creates a software prototype for the image guidance module.
The module prototype is generally created from the ground up. That is, modules for new applications are currently created with no established software platform on which to build new modules. Therefore, the module creator must expend a considerable amount of time and effort building the new prototype module from the ground-up.
In addition, current modules are not easily modified or combined to adapt to changes in any one of procedures or devices. For example, current modules are not easily modified to include an improved medical device. Instead, the entire module must be re-created to account for relatively minor changes in the improved medical device.
Once the prototype is created, the vendor and creator work with doctors and surgeons to work out any errors or “bugs” with both the procedure contained in the module, or with the actual software employed by the module. Both the vendor and module creator must ensure that the module not only employs the proper procedure for inserting the new hip implant into patients of varying ages, sizes and genders, for example, but that the module also functions on varying platforms. The creator hands the prototype off to various doctors and surgeons. The doctors and surgeons then, according to their own time constraints and schedules, evaluate the prototype. The various doctors and surgeons, again on their own schedules, hand the evaluated prototype back to the creator with their feedback. The creator and vendor then again work to eliminate any errors or bugs present in the module before handing the improved prototype back off to doctors and surgeons for their review and feedback. This cycle can involve considerable time and resources, with a limited ability to monitor and “push” the progress of the prototype evaluation. Moreover, during the evaluation of the prototype, the vendor and creator are unable to make any additional fixes or improvements to the module until the doctors and surgeons have completed their evaluations.
After repeated doctor and surgeon evaluations and fixes by the vendor and creator, the creator releases a clinical version of the module software. The vendor submits the module to clinical evaluation by additional doctors and surgeons. Typically the module is used on human cadavers to evaluate the “real world” application of the module. Again, during the clinical evaluation, the vendor, creator, doctors and surgeons work together to remove any errors or bugs contained within the module, both in the procedures employed by the module and in actual programming errors. However, after the module is submitted for clinical evaluation, the vendor and creator are unable to make any additional fixes or improvements to the module until the clinical evaluation has completed.
After clinical evaluation, the module is again handed back to the creator and vendor to remedy any errors or problems encountered during clinical evaluation. Once the module is corrected, the module is again handed to doctors and surgeons for additional clinical evaluation. Again, during the clinical evaluation, the vendor and creator are unable to make any additional fixes or improvements to the module until the clinical evaluation has completed. Eventually, the cycle of clinical evaluation terminates and the module is ready for commercial release.
However, even before the module is ready for commercial release, the vendor and module creator must balance and manage several application schedules into a single release. For example, for the vendor's new hip implant, several modules may apply to the procedure of implanting the hip, tracking the location of the hip during the procedure and aligning the hip once it is implanted. Each application and its associated modules must be built from the ground up, as described above. The vendor and module creator must balance all of these application schedules (including all of their respective prototype and clinical evaluation schedules) in order to schedule a single release of the product. Typically, due to scheduling difficulties occurring during prototype and clinical evaluations, the vendor and module creator are unable to release the product along with the associated modules at their preferred time. For example, the vendor and module creator can miss a preferred trade show.
Thus, current procedures for creating and implementing modules for new applications are wasteful, both in cost and time. The many hand-offs during prototype and clinical evaluations result in delayed releases of new products and modules. In the highly competitive medical products and services industries, a delayed release in a new application can be extremely costly to the late-coming vendor.
Moreover, the handing-off of module prototypes and clinical module versions from the vendor/creator to doctors/surgeons makes the incorporation of changes requested by doctors and surgeons considerably more time-consuming. For example, currently doctors and surgeons can request changes to a developing module, but must make these requests through the proxy of the module developers. Such a process is inherently time-consuming.
Thus, a need exists for a system and method for an improved surgical workflow development. Such a system and method can provide for the utilization of a plug-ins in a surgical workflow module to decrease the amount of time and cost required for module creation, evaluation and validation. Moreover, such a system and method can provide for open and ready access to modules for a plurality of users from remote locations. Such open access can reduce the amount of time required for module scripting and evaluation, as multiple hand-offs are not required.
USPTO Backgrounds
USPTO Backgrounds