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20080269599 - (19 United States US 20080269599A1(12 Patent...

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Unformatted text preview: (19) United States US 20080269599A1 (12) Patent Application Publication (10) Pub. No.: US 2008/0269599 A1 Csavoy et al. (43) Pub. Date: Oct. 30, 2008 (54) METHOD FOR PERFORMING MULTIPLE (21) Appl. No.: 11/739,401 REGISTRATIONS IN A NAVIGATED PROCEDURE (22) Filed: Apr. 24, 2007 (75) Inventors: Andrew N. Csavoy, Minneapolis, Publication Classification MN (US); Matthew S. Solar, lndialantic, FL (US); Jeffrey M. Waynik, Nederland, CO (US); Mark S. Freas, Palm Bay, FL (US) Correspondence Address: HARNESS, DICKEY & PIERCE, P.L.C. P.0. BOX 828 BLOOMFIELD HILLS, MI 48303 (US) (51) Int. Cl. A6IB 5/05 (2006.01) (52) U.S.Cl. ........................................................ 600/426 (57) ABSTRACT A system can be used to navigate or guide an instrument or device into an anatomy of a patient. The navigation can occur with the use of image data acquired of the patient. The image data can be registered to the patient space for navigation. (73) Assignee: MEDTRONIC, INC., Minneapolis, Registration can occur more than once to increase efficiency MN (U S) and speed of the procedure. 16 34 — 22 . 46 13\ \ 30 44 24 34a 0 O o 58 56 34b 72\ 26 58 .. /14 60 3 °\ \ r) J: 5 \ _ A It: 48 0 kg T_I\_‘ l E 20 EB _ / Qua C 52 g 32 50 I 54 Patent Application Publication Oct. 30, 2008 Sheet 1 0f 5 US 2008/0269599 A1 Patent Application Publication Oct. 30, 2008 Sheet 2 0f 5 US 2008/0269599 A1 Patent Application Publication Oct. 30, 2008 Sheet 3 0f 5 US 2008/0269599 A1 Patent Application Publication 152 154 ACQUIRE IMAGE DATA OF PATIENT 156 POSITION PATIENT FOR PROCEDURE 158 ASSOCIATE FIRST DYNAMIC REFERENCE FRAME WITH PATIENT Oct. 30, 2008 Sheet 4 of 5 ACQUIRE POSITION INFORMATION OF PATIENT REGISTER IMAGE SPACE TO PHYSICAL SPACE 174 LOCATE APPROPRIATE POSITION FOR ENTRY PORTAL INTO PATIENT IN IMAGE SPACE MARK PATIENT WITH ENTRY PORTAL [REMOVE—FIRSTDRF] ‘ 178-] [150 180 FORM ENTRY PORTAL ASSOCIATE GUIDE DEVICE WITH PATIENT NEAR PORTAL ASSOCIATE SECOND DRF WITH GUIDE DEVICE REGISTER PATIENT SPACE TO IMAGE SPACE A SECOND TIME NAVIGATE PROCEDURE 192 IS A BILATERAL PROCEDURE TO BE PERFORMED? Fig-5 US 2008/0269599 A1 Patent Application Publication Oct. 30, 2008 Sheet 5 0f 5 US 2008/0269599 A1 US 2008/0269599 A1 METHOD FOR PERFORMING MULTIPLE REGISTRATIONS IN A NAVIGATED PROCEDURE CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is filed concurrently with US. patent application Ser. No. 11/ (Attorney Docket No. 5074N-0000011), entitled “FLEXIBLE ARRAY FOR USE IN NAVIGATED SURGERY.” The disclosure of the above application is incorporated herein by reference. FIELD [0002] The present disclosure relates to a surgical naviga- tion system, and particularly to a method for navigated deliv- ery of deep brain instruments. BACKGROUND [0003] The statements in this section merely provide back- ground information related to the present disclosure and may not constitute prior art. [0004] In an anatomy, such as a human anatomy, various anatomical portions and functions maybe damaged or require repair after a period of time. The anatomical portion or func- tion maybe injured due to wear, aging, disease, or exterior trauma. To assist the patient, a procedure may be performed that may require access to an internal region of the patient through an incision. Due to exterior soft tissue, visualization of portions of the interior of the anatomy maybe difficult or require a large opening in the patient. [0005] Image data maybe required of a patient to assist in planning, performing, and post operative analysis of a proce- dure. For example, magnetic resonance image data can be acquired of the patient to assist in diagnosing and planning a procedure. The image data acquired of the patient can also be used to assist in navigating various instruments relative to the patient while performing a procedure. [0006] It is known to fixedly interconnect fiducial markers with a patient while imaging the patient and substantially using the fiducial markers that are imaged in the image data to correlate or register the image data to patient space. The fiducial markers, to ensure maximum reliability, however, are generally fixed directly to a bone of the patient. It is desirable, in various procedures, to substantially minimize or eliminate the invasiveness of inserting the fiducial markers into the bone through the skin of the patient. It is also desirable to provide an efficient mechanism to allow for registration of the image space to the physical space without requiring a separate procedure to implant one or more fiducial markers. It is also desirable to provide a system that allows for registration of the image space to the patient space without requiring a user to touch or contact one or more fiducial markers on a patient. SUMMARY [0007] During a surgical procedure on an anatomy, such as a human anatomy, instruments, implants, prosthesis, leads, electrodes and the like can be positioned in the anatomy. The various instruments or devices are generally positioned through incisions formed in soft tissue and/or hard tissue, such as the dermis and the cranium, of the anatomy. There- fore, anatomy of the patient can obscure or limit visualization of the devices in the anatomy during the procedure. It may be Oct. 30, 2008 desirable, therefore, to provide a mechanism to determine a position of the devices within the anatomy. [0008] According to various embodiments, a system to reg- ister image space to physical space of a patient for a surgical navigation procedure is disclosed. The system can include a first dynamic reference frame that can be attached relative to the patient in a first manner and a second dynamic reference frame that can be attached to the patient in a second manner. A tracked device can be used to determine a fiducial point on the patient. A processor can correlate the fiducial point on the patient to an image fiducial point in the image data. A tracking system can track at least one of the tracked devices, the first dynamic reference frame, the second dynamic reference frame, or combinations thereof. The processor can register the image space and physical space with the first dynamic reference frame with a first accuracy and can register the image space and physical space with the second dynamic reference frame with a second accuracy. [0009] According to various embodiments, a method to register image space to physical space of a patient for a surgical navigation procedure is taught. The method can include acquiring image data of the patient defining the image space and including an image fiducial point and identifying the image fiducial point in the image data. A first dynamic reference frame can be attached to the patient in a first manner and a first registration of the image space to the physical space having a first accuracy can be performed with the attached first dynamic reference frame. A second dynamic reference frame can be attached to the patient in a second manner and a second registration of the image space to the physical space having a second accuracy can be performed with the attached second dynamic reference frame. [0010] According to various embodiments, a method to register image space to physical space of a patient for a surgical navigation procedure is disclosed. The method can include attaching a fiducial marker with the patient and acquiring image data of the patient including an image fidu- cial point produced by the fiducial marker. The method can also include non-invasively attaching a first dynamic refer- ence frame to the patient in a first manner, performing a first registration of the image data to the physical space having a first accuracy with the attached first dynamic reference frame, and navigating a first procedure with the performed first reg- istration. The method can further include invasively attaching a second dynamic reference frame to the patient in a second manner, performing a second registration of the image data to the physical space having a second accuracy with the con- nected second dynamic reference frame, and navigating a second procedure with the performed second registration. [0011] Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. DRAWINGS [0012] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. [0013] FIG. 1 is an environmental view of a surgical navi- gation system or computer aided surgical system, according to various embodiments; [0014] FIG. 2 is a detailed environmental view of a skin penetrating laser system; US 2008/0269599 A1 [0015] FIG. 3 is a detailed view of a flexible member including tracking devices, according to various embodi- ments; [0016] FIG. 4 is a detailed view of a flexible member including tracking devices, according to various embodi- ments; [0017] FIG. 5 is a detailed environmental view of a flexible member including a plurality of tracking devices; [0018] FIG. 6 is a flow chart ofa process for performing a selected procedure; and [0019] FIG. 7 is an environmental view of a patient includ- ing various elements associated therewith. DETAILED DESCRIPTION [0020] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. Although the following description illus- trates and describes a procedure relative to a cranium of a patient, the current disclosure is not to be understood to be limited to such a procedure. For example, a procedure can also be performed relative to a spinal column, heart, vascular system, etc. Therefore, discussion herein relating to a specific region of the anatomy will be understood to be applicable to all regions of the anatomy, unless specifically described oth- erwise. [0021] As discussed herein various systems and elements can be used to assist in a surgical procedure. For example, image data can be acquired of a patient to assist in illustrating the location of an instrument relative to a patient. Generally, image space can be registered to patient space to assist in this display and navigation. Fiducial markers can be aflixed to the patient during imaging and registration or fiducial marker- less systems can be used. Fiducial marker-less systems can use other techniques, including surface or contour matching, as discussed herein. Various techniques canbe used in fiducial marker-less systems, including, but not limited to, soft tissue penetrating laser systems, flexible members including track- ing devices, etc.Also, procedures can include two registration procedures, including a course and a fine registration. The two registrations can allow for lessoning invasiveness of the procedure and increasing efliciency of the procedure. [0022] With reference to FIG. 1, a navigation system 10 that can be used for various procedures is illustrated. The naviga- tion system 10 can be used to track the location of a device 12, such as a pointer probe, relative to a patient 14 to assist in the implementation or performance of a surgical procedure. It should be further noted that the navigation system 10 may be used to navigate or track other devices including: catheters, probes, needles, leads, electrodes implants, etc. According to various embodiments, examples include ablation catheters, deep brain stimulation (DBS) leads or electrodes, micro- electrode (ME) leads or electrodes for recording, etc. More- over, the navigated device may be used in any region of the body. The navigation system 10 and the various devices may be used in any appropriate procedure, such as one that is generally minimally invasive, arthroscopic, percutaneous, stereotactic, or an open procedure. Although an exemplary navigation system 10 including an imaging system 16 are discussed herein, one skilled in the art will understand that the disclosure is merely for clarity of the present discussion and any appropriate imaging system, navigation system, patient specific data, and non-patient specific data can be used. For example, the intraoperative imaging system can include an MRI imaging system, such as the PoleStar® MRI sold by Oct. 30, 2008 Medtronic, Inc. or an O-armTM imaging system sold by Breakaway Imaging, LLC. having a place of business in Massachusetts, USA. It will be understood that the navigation system 10 can incorporate or be used with any appropriate preoperatively or intraoperatively acquired image data. [0023] The navigation system 10 can include the optional imaging device 16 that is used to acquire pre-, intra-, or post-operative, including real-time, image data of the patient 14. In addition, data from atlas models can be used to produce images for navigation, though they may not be patient images. Although, atlas models can be morphed or changed based upon patient specific information. Also, substantially imageless systems can be used, such as those disclosed in US. patent application Ser. No. 10/687,539, filed Oct. 16, 2003, now US. Pat. App. Pub. No. 2005/0085714, entitled “METHOD AND APPARATUS FOR SURGICAL NAVI- GATION OF A MULTIPLE PIECE CONSTRUCT FOR IMPLANTATION”, incorporated herein by reference. Vari- ous systems can use data based on determination of the posi- tion of various elements represented by geometric shapes. [0024] The optional imaging device 16 is, for example, a fluoroscopic X-ray imaging device that may be configured as a C-arm 18 having an X-ray source 20, an X-ray receiving section 22, an optional calibration and tracking target 24 and optional radiation sensors. The calibration and tracking target 24 includes calibration markers (not illustrated). Image data may also be acquired using other imaging devices, such as those discussed above and herein. [0025] An optional imaging device controller 26 may con- trol the imaging device 16, such as the C-arm 18, which can capture the X-ray images received at the receiving section 22 and store the images for later use. The controller 26 may also be separate from the C-arm 18 and can be part of or incorpo- rated into a work station 28. The controller 26 can control the rotation of the C-arm 18. For example, the C-arm 18 can move in the direction of arrow 30 or rotate about a longitudinal axis 14a of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged. Each of these movements involves rotation about a mechanical axis 32 of the C-arm 18. The movements of the imaging device 16, such as the C-arm 18 can be tracked with a tracking device 34. As discussed herein, the tracking device, according to various embodiments, can be any appropriate tracking device to work with any appro- priate tracking system (e.g. optical, electromagnetic, acous- tic, etc.). Therefore, unless specifically discussed otherwise, the tracking device can be any appropriate tracking device. [0026] In the example of FIG. 1, the longitudinal axis 14a of the patient 14 is substantially in line with the mechanical axis 32 of the C-arm 18. This enables the C-arm 18 to be rotated relative to the patient 14, allowing images of the patient 14 to be taken from multiple directions or in multiple planes.An example of a fluoroscopic C-arm X-ray device that may be used as the optional imaging device 16 is the “Series 9600 Mobile Digital Imaging System,” from GE Healthcare, (formerly OEC Medical Systems, Inc.) of Salt Lake City, Utah. Other exemplary fluoroscopes include bi-plane fluoro- scopic systems, ceiling mounted fluoroscopic systems, cath- lab fluoroscopic systems, fixed C-arm fluoroscopic systems, isocentric C-arm fluoroscopic systems, three-dimensional (3D) fluoroscopic systems, intraoperative O-armTM imaging systems, etc. [0027] The C-arm imaging system 18 can be any appropri- ate system, such as a digital or CCD camera, which are well understood in the art. Two dimensional fluoroscopic images US 2008/0269599 A1 that may be taken by the imaging device 16 are captured and stored in the C-arm controller 26. Multiple two-dimensional images taken by the imaging device 16 may also be captured and assembled to provide a larger view or image of a whole region of the patient 14, as opposed to being directed to only a portion of a region of the patient. For example, multiple image data or sets of data of a patient’s leg, cranium, and brain may be appended together to provide a full view or complete set of image data of the leg or brain that can be later used to follow contrast agent, such as bolus or therapy tracking. The multiple image data can include multiple two-dimensional (2D) slices that are assembled into a 3D model or image. [0028] The image data can then be forwarded from the C-arm controller 26 to the navigation computer and/or pro- cessor controller or work station 28 having a display device 36 to display image data 38 and a user interface 40. The work station 28 can also include or be connected to an image processor, a navigation processor, and a memory to hold instruction and data. The work station 28 can also include an optimization processor that assists in a navigated procedure. It will also be understood that the image data is not necessar- ily first retained in the controller 26, but may also be directly transmitted to the workstation 28. Moreover, processing for the navigation system and optimization can all be done with a single or multiple processors all of which may or may not be included in the workstation 28. [0029] The work station 28 provides facilities for display- ing the image data 38 as an image on the display device 36, saving, digitally manipulating, or printing a hard copy image of the received image data. The user interface 40, which may be a keyboard, mouse, touch pen, touch screen or other suit- able device, allows a physician or user 42 to provide inputs to control the imaging device 16, via the C-arm controller 26, or adjust the display settings of the display 36. The work station 28 may also direct the C-arm controller 26 to adjust the rotational axis 32 of the C-arm 18 to obtain various two- dimensional images in different planes in order to generate representative two-dimensional and three-dimensional images. [0030] While the optional imaging device 16 is shown in FIG. 1, any other alternative 2D, 3D or 4D imaging modality may also be used. For example, any 2D, 3D or 4D imaging device, such as isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography (CT), multi-slice com- puted tomography (MSCT), magnetic resonance imaging (MRI), positron emission tomography (PET), optical coher- ence tomography (OCT) (a more detailed discussion on opti- cal coherence tomography (OCT), is set forth in US. Pat. No. 5,740,808, issued Apr. 21, 1998, entitled “Systems And Methods For Guiding Diagnostic Or Therapeutic Devices In Interior Tissue Regions” which is hereby incorporated by reference). Intra-vascular ultrasound (IVUS), intra-operative CT, single photo emission computed tomography (SPECT), planar gamma scintigraphy (PGS). Addition imaging systems include intraoperative MRI systems such as the PoleStar® MRI system sold by Medtronic, Inc. Further systems include the O-ArmTM imaging system sold by Breakaway Imaging, LLC. The images may also be obtained and displayed in two, three or four dimensions. In more advanced forms, four- dimensional surface rendering regions of the body may also be achieved by incorporating patient data or other data from an atlas or anatomical model map or from pre-operative image data captured by MRI, CT, or echocardiography modalities. Oct. 30, 2008 [0031] Image datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computer tomography (SPECT) com- bined with CT, could also provide functional image data superimposed onto anatomical data to be used to confidently reach targe...
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