Local Doctor's Work Brings Cheers to the O-R

Posted: 8:56 PM Dec 15, 2007
Last Updated: 9:05 PM Dec 15, 2007
http://www.wjhg.com/home/headlines/12537016.html

About a million and a half people in the U.S. suffer from Parkinson's disease. Former Attorney General Janet Reno and actor Michael J. Fox are just two examples of who can be affected. Now, a new device developed by a local physician Dr. Joel Franck is changing lives of the disease’s victims.

Parkinson's is a disorder that affects nerve cells, or neurons, in a part of the brain that controls muscle movement. In Parkinson's, neurons that make a chemical called dopamine die or do not work properly.

Dopamine normally sends signals that help coordinate your movements. No one knows what damages these cells.

Therapies can help ease the debilitating symptoms of Parkinson's disease, but a new device is actually giving Parkinson's patients their lives back.

Parkinson's is common in the elderly and we have an ever-increasing elderly population. So, Dr. Joel Franck notes it's becoming more and more prevalent.

"At least 100-thousand of these patients with Parkinson’s disease are relatively immobile and bed ridden and life is miserable. They are considered candidates for surgery."

Surgery for Parkinson's has come a long way. Now there's a new technique that Dr. Franck has designed to help Parkinson's patients live a more normal life. It's called “Starfix” and it uses deep brain stimulation.

“The goal of deep brain stimulation is to find the areas of the brain that are malfunctioning. So we're not taking anything out, we're not taking brain tumors away, what we're doing is getting the wiring of the brain to work properly again.”

Deep brain stimulation has been around since the 70's but getting it to the precise part of the brain affected was the tricky part. That's where “Starfix” comes in. Patients get dramatic results in minutes, especially since they are awake during the procedure.

"Let's say he has Parkinson's and is violently tremoring and a neurologist will ask the patient to do a certain task, take a cup and bring it to his or her mouth and it will look like this because of the inaccuracy caused by the tremor.

“The electrode is put in the brain. We connect it to a battery pack, basically and press a button and this all of the sudden becomes a normal action.

“There's cheering in the O-R. Literally in moments they become a new person."

There are hundreds of thousands of candidates for this type of surgery. The problem is there are only 32-hundred neurosurgeons in the country, and only about a hundred to a hundred fifty of them can perform this type of surgery.

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Guidance System and Intra-Operative Placement
http://www.patentstorm.us/patents/71...scription.html

Traditional methodology for carrying out this stepwise target localization and implantation procedure has been based on an externally fixed, rigid fixture, called a stereotactic frame that encompasses the patient's head and upon which the micro-manipulating equipment can be mounted and maneuvered with sub-millimetric precision. These various stereotactic frames have been optimized to obtain accurate images used to create the initial target trajectory and plan and then to reduce erroneous movement associated with passage of the test electrodes and the final implantation [5]. These frames typically require mounting the day of surgery, subsequent imaging with either CT and/or MRI axial slices, and target planning prior to starting the actual procedure of intra-operative mapping and ultimate placement of the electrode implantation into the final target.

Recently, a FDA approved miniature stereotactic frame, called a Starfix platform (microTargeting.RTM., FHC Corporation; Bowdoinham, Me.), has become clinically available. This device, also referred as a platform hereafter, allows for more versatility with elective stereotactic procedures, such as DBS implantation. Referring to FIGS. 2A and 2B, the platform 200 has a platform body 210, an adjustor 220 attached to the platform body 210 and a plurality of legs 230 outwardly and equal-angularly extending from the platform body 210. Each of the plurality of legs 230 has a hole 280 at an end portion for receiving a corresponding fiducial marker post 240 implanted into the outer table of the skull of a patient so as to secure the platform 210. The platform 210 also has a guiding member 250. The guiding member 250 has a plurality of guiding tubes 260 including a center guiding tube 270. The positions of the guiding tubes 260 including the central tube 270 can be adjusted by the adjustor 220. The platform 210 is currently manufactured as a customized tripod that can be mounted onto bone-based fiducial marker posts 240. Each platform is uniquely manufactured based on a stereotactically planned trajectory using software designed to mathematically relate the location of such bone markers with respect to brain structures [6]. The bone-based fiducial markers having a fluid-filled cylinder that is visible on both CT and MR images is detachably attached to a post that is implanted into the outer table of the skull. These images can then be used in the stereotactic software to designate a trajectory in relation to the bone-based marker posts. The plan is sent to the manufacturer who then translates the stereotactic plan into a customized platform for a given trajectory through a rapid prototyping facility. The resultant platform is shipped to the hospital within a certain time frame and is used for mounting the same types of micromanipulators that are used on traditional stereotactic frames. The remaining portion of the procedure is the same with respect to intra-operative localization of the final target of implantation with the patient awake.

Each patient undergoing surgery receives either one (for unilateral DBS implantation) or two (for bilateral DBS implantation) platforms. Each leg of the platform is attached to a corresponding bone-implanted post. For each patient, the acquisition of data proceeds in three stages. First, under anesthesia, the fiducial marker posts are implanted onto predetermined positions on the skull of the patient, Acustar™ (Z-Kat, Inc., Hollywood, Fla.) fiducial markers are attached to the posts. The use of this marker and post in open craniotomies has been reported on earlier [6]. Other fiducial markers and posts can also be used to practice the present invention. CT and MR image volumes are acquired with the patient anesthetized and head taped to the table to minimize motion. For examples, CT images acquired at kvp=120 V, exposure=350 mas, 512×512 pixels ranging in size from 0.49 to 0.62 mm, slice thickness=2 mm for one patient, 1.3 mm for 2 patients, 1 mm for all others. MR images are 3D SPGR volumes, TR: 12.2, TE: 2.4, voxel dimensions 0.85×0.85×1.3 mm3 except for subject S7 for which the voxel dimensions are 1×1×1.3 mm3. After image acquisition, the fiducial markers are removed. With the help of MR-CT registration software, for instance, VoXim.RTM. (FHC Corporation, Bowdoinham, Me.), the surgeon selects the initial target points based on AC-PC coordinates and associated entry points on the surface of the skull. In addition, the centroids of the markers and the directions of their posts are determined from the acquired images. These data are sent electronically to a fabrication plant where a customized platform is manufactured to fit the posts and provide an opening positioned over the entry point and oriented toward the target.

Second, surgery begins with the drilling of a burr hole, for instance, have 14 mm in diameter. Referring to FIG. 3, an adaptor (not shown here) is attached to each post 352, the platform 350 is attached to the adaptors, and a micropositioning drive 310 is attached to the platform 350. In one embodiment, microTargeting.RTM. (FHC Corporation, Bowdoinham, Me.) is employed as the micropositioning drive. A microelectrode recording lead is placed into the patient at the selected initial target position through the central tube of the guide member attached to the platform. The position of the microelectrode recording lead, thus the selected initial target position, is adjusted so that resting firing frequencies are noted or detected. The adjustment involves three-dimensional adjustment. In addition to changes in depth, it is possible to re-insert a probe 320 along parallel tracks distributed within a 10 mm circle around the initial track. The microelectrode lead is removed and a unipolar macrostimulation lead is inserted to the adjusted position as determined by the microelectrode recordings. With the patient awake, response to stimulation generated from the macrostimulation lead is monitored as the position of the macrostimulation lead is further adjusted until optimal stimulation to the deep brain target is detected. When the final positions are selected, the macrostimulation lead is removed and a deep brain stimulator lead is inserted at the final position. In one embodiment, the DBS lead includes at least one of Medtronic #3387 and #3389 quadripolar lead.RTM. (Medtronic, Inc., Minneapolis, Minn.), as shown in FIG. 1 as described supra. Other types of DBS lead can also be utilized to practice the present invention. The lead is inserted to a deep such that the centroid 160 of the four electrodes 110 140 of the DBS lead 100 is coincident with the final position of the electrode on the unipolar macrostimulation lead. The proximal end of the DBS lead is then anchored to the skull and buried beneath the scalp. The platform is then removed. Within twenty-four hours of surgery, the imaging markers are re-attached to the posts and a post-operative CT scan is acquired. If no complications occur, the patient is discharged home within a day of the surgery. During the entire procedure coordinates are read on the mircodrive. These physical coordinates can be transformed into pre-operative CT coordinates using the software used for pre-operative planning.

Third, within about two weeks the patient is brought back to the operating room and the DBS lead is attached to an internal pulse generator, for example, Soletra (Medtronic, Inc., Minneapolis, Minn.), under general anesthesia. This is usually done as an outpatient procedure. Programming of the generators is performed typically as an outpatient one month later by a neurologist.

To assess the final position of the DBS in the post-operative CT scans, the centroid of the DBS contact-electrodes needs to be detected in the CT images. Referring back to FIG. 1, the DBS lead 100 includes four exposed platinum/iridium contact-electrodes 110, 120, 130 and 140. The centroid 160 of the DBS contact-electrodes is at midway between the inner two contact-electrodes 120 and 130, which is the target point to which the surgeon attempts to deliver stimulation. Referring to FIG. 4, a post-operative CT image 400 of a patient after the bilateral DBS implantation having two DBS leads 410 is shown. The wire leads 420 are running under skin from the DBS leads 410 to the internal pulse generator.