In the field of image-guided cranial surgery, a localizing camera in the operating room tracks the positions of surgical tools in three-dimensional space. This positional information is transmitted from the localizing camera to a computer. The computer's monitor displays multiplanar, three-dimensional radiographic images of the patient's head and brain that have been uploaded into the computer. The patient's cranial anatomy as positioned in the operating room is registered to the radiographic image data using a probe that is tracked by the localizing camera. In image-guided surgery, registration is the process that transforms the three-dimensional radiographic data set (image space) so that it correlates with the three-dimensional coordinates of the corresponding patient anatomy (surgical space). Following registration of the cranial anatomy, the navigation system can display the positions of the tracked surgical tools relative to the displayed radiographic anatomy. In order for this process to be accurate, the three-dimensional spatial relationship between the localizing camera and the patient's head must be known and maintained. If the localizing camera moves or if the patient's head moves during surgery, the navigation system's accuracy deteriorates. In order to compensate for this issue, a tracked tool known as a dynamic reference frame is fixed in relationship to the patient's head. If the patient's head and the localizing camera move relative to one another, their three-dimensional relationship is recalculated by the navigation system computer and the registration solution is updated. Typically, the dynamic reference frame is fixed to the clamp that holds the patient's head in a stationary position for surgery.
While the above measures can serve to maintain the accuracy of image-guided cranial surgery, they have limitations. In order to track the dynamic reference frame, the localizing camera measures the spatial coordinates of markers on the reference frame in the x-axis, y-axis, and z-axis. The accuracy of these measurements changes as the viewing angle changes between the camera and the markers. It is a common practice to move the camera to maintain its line of sight for localizing the dynamic reference frame to accommodate such things as microscopes, various instruments, and additional operating room personnel entering the surgical field. As well, the patient's head is often repositioned during brain surgery, such as occurs when elevating the head of the operating room table, rotating the table, and raising or lowering the table. In these instances, navigational error is inadvertently induced when the camera moves relative to the markers on the dynamic reference frame.
Conventional head clamps include loose fittings that allow the patient's head to move in the head clamp. When the localizing camera is tracking the dynamic reference frame, the navigation system assumes that there is no movement of the head relative to the reference frame. However, in actual use there may be as much as 4 mm of head movement relative to the head clamp (and thus to the dynamic reference frame fixed to the head clamp). The error introduced by this relative movement is not detected by the navigation system and does not provide the optimal accuracy needed in cranial surgery.
Additionally, the head clamp is nonsterile and requires a sterile drape to maintain a sterile field during cranial surgery. In typical image-guided cranial surgery, the registration process is carried out prior to the application of the sterile drape because the drape obscures portions of the patient's cranial anatomy that need to be visible and accessible during registration. A nonsterile dynamic reference frame is used during this process. Following registration, the nonsterile dynamic reference frame is removed, the patient's head is prepared and draped in sterile fashion, and a sterile dynamic reference frame is attached to the head clamp through the drapes. Errors are inadvertently introduced when the nonsterile dynamic reference frame is removed and replaced with a sterile dynamic reference frame.
There remains a need for instruments and techniques that minimize or eliminate relative motion between the localizing camera and the dynamic reference frame during image-guided cranial surgery. There further remains a need to minimize line of sight issues during these surgeries.
Devices, systems, and methods are provided that are designed to minimize relative motion between a localizing camera and a patient's head during cranial surgery. An improved head clamp is provided that minimizes the relative motion between the clamp and the patient's head. A small localizing camera is provided that is rigidly mountable to the improved head clamp such that relative motion between the clamp and the localizing camera is eliminated, the need for a dynamic reference frame is eliminated, and line of sight issues are minimized during image-guided surgery. A camera mount system is provided that is designed to be secured directly to a patient's head. Methods for improving the accuracy of image-guided surgery by utilizing the improved head clamp and the rigidly mountable localizing camera, and by using the camera mount system, are provided.
Disclosed herein is an apparatus, system, and method for providing a rigid connection between a localizing camera and a patient's head to facilitate image-guided surgery. A fixed camera head clamp includes a camera mount rigidly connected to a head clamp. The camera mount includes a camera receptacle configured to rigidly secure a localizing camera thereto such that the localizing camera is in a fixed position near the patient's head. The localizing camera may have a close view range, e.g., 1 cm to 75 cm, and a wide field of view, e.g., at least 120 degrees. The joints of the fixed camera head clamp provide rigid connections to reduce movement or backlash when the patient's head or body is moved or when the head clamp is adjusted. The fixed camera system eliminates the need to move the localizing camera around the operating room. The fixed camera system also eliminates the need for a dynamic reference frame. The fixed camera head clamp system also includes a drape configured to fit over the localizing camera such that the camera does not need to be removed and replaced after registering the patient with the localizing camera. Thus, the fixed camera system minimizes the error in conventional systems by reducing the relative motion between the camera and the patient, eliminating the dynamic reference frame, and improving the draping process. This results in improved navigation system accuracy. A camera mount system includes a camera mount secured to a patient's head and a localizing camera secured to a camera receptacle on the camera mount. The camera mount may be secured to the patient's head using a pin assembly. The camera mount system may be used to facilitate image-guided surgery in which the patient's head is mobile.
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First pin assembly 28 is secured to first upper end 18, and second pin assembly 30 is secured to second upper end 22 of frame 14. Second pin assembly 30 may include one or more pins extending into central space 26. For example, second pin assembly 30 may include one pin 32. First pin assembly 28 may include one or more pins extending into central space 26.
For example, first pin assembly 28 may include two pins 34. First pin assembly 28 and pins 34 are separated from second pin assembly 30 and pin 32 by central space 26.
First pin assembly 28 may include rotating base 36 and rotational lock 38. Pins 34 may be secured to rotating base 36 to selectively rotate pins 34. When in an engaged position, rotational lock 38 may prevent rotation of rotating base 36 thereby locking the position of each pin 34. In one embodiment, rotational lock 38 completely prevents rotation of rotating base 36 in the engaged position. In another embodiment, rotational lock 38 prevents rotation of pins 34 with zero backlash.
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Camera 102 may be a localizing camera. In one embodiment, camera 102 may have an integrated accelerometer and gravitometer. Camera 102 may have a wide field of view. For example, camera 102 may have a field of view of at least approximately 120 degrees. Camera 102 may also have a close range. For example, camera 102 may have a range of approximately 1 cm-75 cm. In one embodiment, camera 102 may be a Mini Optical 3D, USB camera sold by Intellijoint Surgical.
In one embodiment, camera mount 16 may be formed of an I-shaped beam to eliminate or reduce deflection of camera mount 16 when camera 102 is attached to camera receptacle 80. Because camera 102 is rigidly secured to camera mount 16, which is in turn rigidly secured to fixed frame portion 20, there is reduced relative movement between camera 102 and a patient's head positioned in central space 26 between pin 32 and pins 34. In some embodiments, the rigid connections of fixed camera head clamp system 100 results in no relative movement between camera 102 and a patient's head positioned in central space 26.
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Camera mount 16 may then be connected to receptacle 40 at a desired angle relative to fixed frame portion 20. Lock projections 66 (shown in
Camera 102 may then be attached to camera mount 16. Camera base 104 may be secured to camera receptacle 80 on camera mount 16 as described above. Camera 102 may be positioned such that a lens of camera 102 faces a direction that approximately parallel to camera mount 16. Drape 108 may then be positioned over camera 102 and camera mount 16. The patient's anatomy may then be registered by camera 102 using standard registration methods employed by surgical navigation systems. The patient may then be draped and the surgery may be performed.
During the surgery, camera 102 may transmit information to a surgical navigation system that generates and displays multiplanar, three-dimensional images of the patient's anatomy and the position of the surgeon's instruments on a monitor in the operating room. This system enables cranial surgical navigation without dynamic referencing because it provides a rigid connection between the patient's head 112 and camera 102. Error and inaccuracies are reduced or eliminated by system 100 because there is no need to move camera 102 around the operating room and camera 102 remains in a fixed position relative to the patient's head.
Because the sterile drape 108 is applied over the camera 102 while camera 102 remains rigidly fixed to the head clamp instead of removing and reattaching the dynamic referencing frame in conventional systems, fixed camera head clamp system 100 eliminates this additional step that introduces error or inaccuracies in conventional systems. The patient can be registered before or after the sterile drape is applied over camera 102.
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In an alternate embodiment, camera mount 16 may be attached to any existing head clamp. In this embodiment, proximal end 60 of camera mount 16 may be configured to be secured to a fitting on the existing head clamp. For example, the fitting of the existing head clamp may include the same projections and recesses as the upper surface of receptacle 40 described herein. In another example, proximal end 60 may include a plurality of ridges, such as a starburst configuration, that is configured to be secured to a receptacle of the existing head clamp. In other embodiments, a small localizing camera may be directly attached to any immobilizing device, such as a head frame (including existing head frames), using any affixation mechanism, including but not limited to a clamp, a vice grip, adhesive, tape. In yet another embodiment, a localizing camera may be fixed directly to the patient's head.
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Except as otherwise described or illustrated, each of the components in this device may be formed of aluminum, steel, another metal, plastic, or any other durable material. Each device described in this disclosure may include any combination of the described components, features, and/or functions of each of the individual device embodiments. Each method described in this disclosure may include any combination of the described steps in any order, including the absence of certain described steps and combinations of steps used in separate embodiments. Any range of numeric values disclosed herein includes any subrange therein. Plurality means two or more.
While preferred embodiments have been described, it is to be understood that the embodiments are illustrative only and that the scope of the invention is to be defined solely by the appended claims when accorded a full range of equivalents, many variations and modifications naturally occurring to those skilled in the art from a review hereof.
This application is a non-provisional, and claims the benefit, of U.S. Provisional Patent Application No. 62/985,673, filed on Mar. 5, 2020, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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62985673 | Mar 2020 | US |