(19) United States (12) Patent Application Publication (10) Pub

US 20040122446A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0122446 A1 Solar (43) Pub. Date: Jun. 24, 2004

(54) ORGAN ACCESS DEVICE AND METHOD (57) ABSTRACT

(76) Inventor' Matthew 8' Solar’ Indlalannc’ FL (Us) An insertion guide is shown that includes at least one Correspondence Address: insertion point adjustment device. Auser such as a surgeon SCHWEGMAN’ LUNDBERG’ WOESSNER & is able to adjust a lateral position of an insertion point to KLUTH P_A_ more precisely center the insertion point Within an opening P_0_ BO’X 2938 in a subject, such as a burr hole. Selected insertion guide MINNEAPOLIS MN 55 402 (Us) devices further include a centering guide that easily indi ’ cates to a user When the insertion point is substantially (21) APPL NO. 10/325,615 centered Within the opening in the subject. Selected insertion guide devices include adjustability of multiple degrees of (22) Filed; Dec_ 20, 2002 rotational freedom of an insertion axis. Selected insertion guide devices further permit a user to ?x multiple degrees of Publication Classi?cation rotational freedom of an insertion axis using a single locking device. Tissue damage due to an attachment procedure of an (51) Int. Cl.7 ...... A61B 19/00 insertion guide device is reduced using selected con?gura (52) US. Cl...... 606/129 tions described herein. Patent Application Publication Jun. 24, 2004 Sheet 1 0f 10 US 2004/0122446 A1 Patent Application Publication Jun. 24, 2004 Sheet 2 0f 10 US 2004/0122446 A1

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INSTALL FIDUCIAL MARKERS ON A SUBJECT I IMAGE: THE SUBJECT IN RELATION TO THE FIDUCIAL MARKERS I IDENTIFY TARGET LOCATION AND COMPUTE TRAJECTORY IN RELATION TO THE EIDUCIAL MARKERS I ADJUST DEGREES OE FREEDOM ON INSERTION GUIDE TO SUBSTANTIALLY COINCIDE WITH THE COMPUTED TRAJECTORY I MOUNT INSERTION GUIDE TO THE EIDUCIAL MARKERS I IE NECESSARY, ON-SUBJECT ADJUSTMENT OE THE'DEGREES ‘OF FREEDOM OF THE INSERTION GUIDE I TRAJECTORY ALIGNMENT COMPLETE US 2004/0122446 A1 Jun. 24, 2004

ORGAN ACCESS DEVICE AND METHOD subject. In neurosurgery, the insertion guide device is fre quently attached to the subject’s skull using bone screWs. FIELD OF THE INVENTION The screWs may not center in their ideal location, making precise alignment of the insertion guide device dif?cult. [0001] The present invention relates to guiding devices. Speci?cally, the invention relates to trajectory guidance of Further, in neurosurgery, a cranial drill is used to open a burr hole in the subject’s skull. Variations in skull material, as medical devices for procedures such as catheter or lead Well as limitations of the drilling operation can cause the insertion. burr hole location to deviate from it’s ideal location, and the burr hole is not alWays perfectly round. BACKGROUND OF THE INVENTION [0008] What is needed is a method and device that can be [0002] A desire to reduce the disturbance of tissue during adjusted to compensate for location errors of an insertion surgical procedures drives methods and devices for surgical guide device. What is also needed is a method and device insertion such as catheter insertion. The term “catheter” as that can be adjusted to compensate for location errors in used in this document is a broad term that generally forming an opening in a subject. What is also needed is a describes an elongated tube for insertion into a region of a method and device that in other Ways, improves accuracy subject. Catheters include, but are not limited to, drug and ease of use of an insertion guide device. delivery catheters, optical catheters, micro-catheters, host catheters, etc. A small diameter catheter can be inserted into SUMMARY OF THE INVENTION a subject along an insertion trajectory toWards a target location Within the subject With a minimal disturbance to [0009] The above mentioned problems of adjustability are surrounding tissue. addressed by the present invention and Will be understood [0003] A draWback to catheter insertion procedures is that by reading and studying the folloWing speci?cation. Devices the target location is hidden Within the subject. Only a small and methods are provided for adjusting an insertion guide opening in the subject alloWs insertion of the catheter. device. The devices, and methods of the present invention Imaging techniques such as computed tomography (CT), further offer improved accuracy and ease of use. magnetic resonance imaging (MRI) ultrasonic imaging, etc. [0010] An insertion guide device is provided. The inser are helpful in guiding a surgeon or other operator to insert tion guide device includes a base unit and an insertion guide the catheter toWards the target location Within the subject. portion coupled to the base unit. The insertion guide portion Insertion guide devices are also useful in guiding the sur includes a guide aXis that intersects a subject surface at an geon. insertion point. The insertion guide device also includes at [0004] Local mounted insertion guide devices are desir least one attachment device coupled to the base unit, the able, in contrast to other guide devices such as head frames attachment device being adapted for attachment to a subject. as used in neurosurgery. Local mounted insertion guide The insertion guide device also includes an insertion point devices are not as cumbersome as head frames due to their adjustment device coupled betWeen the base unit and the light Weight and smaller siZe. The subject does not need to attachment device, Wherein a location of the insertion point be immobiliZed after imaging as is the case With head frame is adjustable Within the subject surface. technology. Local mounted insertion guide devices are also [0011] A method of aligning an insertion guide device is less expensive to manufacture. In many instances they are also provided. The method includes providing a base unit, fabricated from plastic materials, and may be disposable. and coupling an insertion guide portion to the base unit. The Further, in contrast to head frame technology, local mounted insertion guide portion includes a guide aXis that intersects insertion guide devices alloW a subject to break up a surgical a subject surface at an insertion point. The method also procedure into at least tWo different visits to the hospital. includes coupling at least one attachment device to the base [0005] One visit may include imaging, Where a number of unit Where the attachment device adapted for attachment to reference points called ?ducial markers are attached to a a subject. The method also includes adjusting an insertion subject. A target location tissue is imaged along With the point adjustment device coupled betWeen the base unit and ?ducial markers, thus giving the surgeon a reference loca the attachment device, to select a location of the insertion tion of the target location in relation to the ?ducial markers. point Within the subject surface. If the ?ducial markers are left secured to the subject, the [0012] A method of aligning an insertion guide device is subject may noW return home and complete a surgical also provided including providing a base unit and coupling procedure at a second visit because the ?ducial markers an insertion guide portion to the base unit, the insertion preserve a reference frame for the surgeon to target and Work guide portion having a guide aXis that intersects a subject With. This Was not possible using head frame technology, surface at an insertion point. The method also includes Where a subject needed to remain secured inside a head coupling at least one attachment device to the base unit, the frame until after completion of the surgical procedure. attachment device adapted for attachment to a subject. The [0006] Using a local mounting technique, an insertion method also includes adjusting the guide aXis With respect to guide device is also attached to the subject. The function of the base unit prior to attaching the insertion guide device to the insertion guide device is to guide a catheter along an aXis the subject. The method also includes adjusting an insertion into the subject to the target location Where a selected point adjustment device coupled betWeen the base unit and operation such as drug delivery, tissue removal, etc. is the subject, to select a location of the insertion point Within performed. the subject surface. [0007] A dif?culty With this procedure arises in location [0013] A method of manufacturing an insertion guide tolerance When the insertion guide device is attached to the device is also provided. The method includes forming a base US 2004/0122446 A1 Jun. 24, 2004

unit and coupling an insertion guide portion to the base unit. [0028] FIG. 6B shoWs a cross section vieW of a portion of The insertion guide portion includes a guide axis that a ?ducial marker according to one embodiment of the intersects a subject surface at an insertion point. The method invention. also includes coupling at least one attachment device to the base unit, the attachment device being adapted for attach [0029] FIG. 6C shoWs a portion of a ?ducial marker according to one embodiment of the invention. ment to a subject. The method also includes coupling an insertion point adjustment device betWeen the base unit and [0030] FIG. 6D shoWs a portion of a ?ducial marker the attachment device, Wherein a location of the insertion according to one embodiment of the invention. point is adjustable Within the subject surface. [0031] FIG. 7 shoWs an isometric vieW of an insertion [0014] These and other embodiments, aspects, advan guide device according to one embodiment of the invention. tages, and features of the present invention Will be set forth [0032] FIG. 8 shoWs an isometric vieW of an insertion in part in the description Which folloWs, and in part Will guide device according to one embodiment of the invention. become apparent to those skilled in the art by reference to the folloWing description of the invention and referenced [0033] FIG. 9 shoWs a How diagram of one method of draWings or by practice of the invention. The aspects, operating an embodiment of the invention. advantages, and features of the invention are realiZed and attained by means of the instrumentalities, procedures, and DETAILED DESCRIPTION OF THE combinations particularly pointed out in the appended PREFERRED EMBODIMENTS claims. [0034] In the folloWing detailed description of the inven tion, reference is made to the accompanying draWings Which BRIEF DESCRIPTION OF THE DRAWINGS form a part hereof, and in Which is shoWn, by Way of illustration, speci?c embodiments in Which the invention [0015] FIG. 1 shoWs a coordinate system in one embodi may be practiced. In the draWings, like numerals describe ment of a neurosurgical procedure. substantially similar components throughout the several [0016] FIG. 2 shoWs an isometric vieW of an insertion vieWs. These embodiments are described in suf?cient detail guide device according to one embodiment of the invention. to enable those skilled in the art to practice the invention. Other embodiments may be utiliZed and structural changes, [0017] FIG. 3A shoWs a side vieW of a portion of an logical changes, etc. may be made Without departing from insertion guide device according to one embodiment of the the scope of the present invention. invention. [0035] FIG. 1 shoWs a subject surface 100 along With one [0018] FIG. 3B shoWs a cross section vieW of a portion of possible coordinate system for de?ning locations and ori an insertion guide device according to one embodiment of entations With respect to the subject. In one embodiment, the the invention. subject surface 100 includes a skull of a subject. An opening [0019] FIG. 3C shoWs an isometric vieW of a part of an 102 in the subject surface is shoWn, along With a target insertion guide device according to one embodiment of the location 104 Within the subject. In one embodiment, the invention. opening 102 includes a burr hole. An insertion aXis 110 is shoWn that begins outside the subject surface 100 and ends [0020] FIG. 4 shoWs a side vieW of a centering guide at the target location 104. The insertion aXis 110 further according to one embodiment of the invention. passes through an insertion point 112 on its Way to the target [0021] FIG. 5A shoWs an isometric vieW of a portion of location 104. The insertion point 112 is shoWn substantially an insertion guide device according to one embodiment of Within the center of the opening 102. the invention. [0036] In three dimensional space, using the chosen coor [0022] FIG. 5B shoWs a top vieW of a portion of an dinate system shoWn in FIG. 1, the insertion aXis 110 can be insertion guide device according to one embodiment of the rotated about the insertion point 112 and further about any invention. of three orthogonal aXes that pass through the insertion point 112. In this Way, any orientation of the insertion aXis 110 can [0023] FIG. 5C shoWs a cross section vieW along line be selected, While still passing through the insertion point 5C-5C of a portion of an insertion guide device according to 112. In one embodiment, rotation about at least tWo of the one embodiment of the invention. three orthogonal aXes is used to select an orientation of the [0024] FIG. 5D shoWs a top vieW of a portion of an insertion aXis 110. Although orthogonal aXes are shoWn, insertion guide device according to one embodiment of the non-orthogonal aXes passing through the insertion point are invention. also possible Within the scope of the invention. [0025] FIG. 5E shoWs a cross section vieW along line [0037] In one embodiment, a ?rst rotational degree of 5E-5E of a portion of an insertion guide device according to freedom shoWn by arroW 122 is included. The ?rst rotational one embodiment of the invention. degree of freedom is used for orienting the insertion aXis 110. As shoWn, the ?rst rotational degree of freedom rotates [0026] FIG. 5F shoWs a cross section vieW along line about a ?rst rotational aXis 120 that passes through the 5F-5F of a portion of an insertion guide device according to insertion point 112. In the embodiment shoWn, the ?rst one embodiment of the invention. rotational aXis 120 is normal to the subject surface 100 at the insertion point 112. [0027] FIG. 6A shoWs a cross section vieW of a portion of a ?ducial marker according to one embodiment of the [0038] In one embodiment, a second rotational degree of invention. freedom shoWn by arroW 132 is included. The second US 2004/0122446 A1 Jun. 24, 2004

rotational degree of freedom is used for orienting the inser insertion aXis 222 in the ?rst rotational degree of freedom as tion axis 110. As shoWn, the second rotational degree of selected. In one embodiment, the locking device includes a freedom rotates about a second rotational aXis 130 that threaded lock ring. passes through the insertion point 112. In the embodiment [0044] Also shoWn in FIG. 2 is a second angular adjust shoWn, the second rotational aXis 130 is tangent to the ment device 260 for adjusting a second rotational degree of subject surface 100 at the insertion point 112. freedom. The second angular adjustment device 260 permits [0039] In one embodiment, a third rotational degree of rotation of the insertion aXis 222 about the insertion point freedom shoWn by arroW 142 is included. The third rota and further about a second rotational aXis. In one embodi tional degree of freedom is used for orienting the insertion ment, the second rotational aXis is substantially tangent to aXis 110. As shoWn, the third rotational degree of freedom the subject surface at the insertion point. In one embodi rotates about a third rotational aXis 140 that passes through ment, the second angular adjustment device 260 includes a the insertion point 112. In the embodiment shoWn, the third rail 262 that guides the adjustment of the second angular rotational aXis 140 is tangent to the subject surface 100 at the adjustment device 260. In one embodiment, a pair of rails insertion point 112. 262 are used. In one embodiment, a locking device 264 is used to secure an orientation of the insertion aXis 222 in the [0040] The ?rst degree of rotational freedom, the second second rotational degree of freedom as selected. In one degree of rotational freedom, and the third degree of rota embodiment, the locking device 264 includes one or more tional freedom all leave the location of the insertion point set screWs. 112 ?xed. The degrees of rotational freedom rotate about the insertion point 112 because the location of the opening in the [0045] A centering guide 270 is further shoWn in FIG. 2. subject 102 remains ?xed during a surgical procedure. In In one embodiment, the centering guide is ?Xed Within the insertion guide portion 220 using a locking device 224. In one embodiment, a ?rst degree of translational freedom is one embodiment, the locking device 224 includes one or also included. In one embodiment a ?rst degree of transla tional freedom is de?ned by the adjustability of the location more set screWs. Embodiments of the centering guide are discussed in more detail later in the speci?cation. of the insertion point 112 along direction 114. In one embodiment, a second degree of translational freedom is [0046] In one embodiment, selected elements of an inser also included Where the location of the insertion point 112 is tion guide device such as insertion guide device 200 are adjustable along direction 116. fabricated from a substantially transparent material. Examples of transparent materials include, but are not [0041] FIG. 2 shoWs one embodiment of an insertion limited to, polycarbonate, crystalline polymers, glasses, etc. guide device 200. The insertion guide device 200 includes a An advantage of at least some of the elements of an insertion base unit 210, and an insertion guide portion 220 coupled to guide device being transparent is that it alloWs a user or the base unit 210. The insertion guide portion 220 deter surgeon to better vieW the opening in the subject, and to mines an insertion aXis 222. Anumber of attachment devices vieW Within the opening into the subject. In many proce 230 are also shoWn coupled to the base unit 210. In one dures, it is important to be able to vieW the opening in the embodiment, the attachment devices include a bone screW subject, and further to vieW locations Within the opening. 232. The attachment devices 230 are coupled to the base unit Embodiments of insertion guide devices as described in this 210 through a number of insertion point adjustment devices document are mounted to the subject at locations that are 240. In one embodiment, the insertion point adjustment spaced laterally apart from the opening, thus providing a devices 240 include a split clamping portion 241 and a screW user or surgeon a better vieW of the opening. By further 242. The insertion point adjustment devices 240 alloW the designing elements of an insertion guide device With sub base unit to be adjusted With respect to the attachment stantially transparent material, a surgeon’s ability to see the devices 230 substantially along direction 244. In one opening and inside the opening is increased. embodiment an insertion point adjustment device 240 is included for each attachment device 230. In one embodi [0047] FIG. 3A shoWs an embodiment of an attachment ment, the insertion guide device 200 includes three attach device 330 and an insertion point adjustment devices 340 ment devices 230 and three insertion point adjustment attached to a subject surface 300. In one embodiment, the devices 240. attachment device 330 includes a truncated cone portion 334 and a securing device 332 such as a bone screW. In one [0042] By adjusting at least one insertion point adjustment embodiment, the insertion point adjustment devices 340 devices 240, an insertion point (not shoWn) of the insertion includes a threaded portion 341 coupled to a gripping aXis 222 is translated through at least one degree of trans portion 342. In one embodiment, the gripping portion 342 lational freedom to a selected location Within the subject includes a knurled knob portion. In one embodiment, the surface. Three attachment devices are convenient because threaded portion 341 engages a portion of a base 310 to they provide the most stable platform With a minimum provide motion of the base 310 substantially along direc number of contact points on the subject. tional arroWs 344 With respect to the attachment device 330. [0043] FIG. 2 also shoWs a ?rst angular adjustment device [0048] FIG. 3B shoWs a cross section of the attachment 250 for adjusting a ?rst rotational degree of freedom. The device 330 and an insertion point adjustment devices 340 of ?rst angular adjustment device 250 permits rotation of a FIG. 3A. In one embodiment, the threaded portion 341 and component of the insertion aXis 222 about a ?rst rotational the gripping portion 342 are separately fabricated from the aXis that is substantially normal to the subject surface at the attachment device 330. In one embodiment, the threaded insertion point. The rotation of the insertion aXis 222 in the portion is rotatably coupled to the attachment device 330 by ?rst rotational degree of freedom is shoWn by arroWs 254. A a retaining device 338. In one embodiment, the retaining locking device 252 is shoWn to secure an orientation of the device 338 includes a barb. Arotatably coupled arrangement US 2004/0122446 A1 Jun. 24, 2004

allows the attachment device 330 to remain substantially ment, the translational location of the insertion point can be ?xed While adjustments are made to the threaded portion adjusted using insertion point adjustment devices as 341. described above. In one embodiment, a centering guide can be further utiliZed to indicate to a user When the insertion [0049] FIG. 3C shoWs one embodiment of an embodi point is aligned With the center of the opening in the subject. ment of an attachment device 350 including a substantially In one embodiment, When the insertion point has been linear contact surface 352. In one embodiment, features such moved such that the second diameter portion 476 ?ts at least as the substantially linear contact surface 352 and the partially Within the opening in the subject, the insertion point truncated cone portion 334 help to reduce tissue damage due is aligned With the opening in the subject. to attachment of the insertion guide device to a subject. [0050] During many surgical procedures utiliZing attached [0054] In one embodiment, a centering device is used to devices such as an insertion guide device, tissue damage as center an insertion point of an insertion guide device over an a result of attachment is an issue. In one embodiment, tissue opening in a subject prior to attachment of the insertion damage is reduced by utiliZing a minimum number of guide device on the subject. The centering device alloWs a attachment devices. In one embodiment, three attachment fast and ef?cient location of attachment points for the devices are used to maintain a stable platform for the insertion guide device in embodiments Where the location of insertion guide device While minimiZing a number of attach attachment points has not already been determined. ment locations. In one embodiment, the attachment devices [0055] FIG. 5A shoWs a portion of an insertion guide are located apart from the opening in the subject, such as a device 500. In one embodiment, attachment devices and burr hole. The more remote location of attachment devices insertion point adjustment devices as described above are reduces tissue damage at the opening or burr hole location. used in conjunction With embodiments described in FIGS. In one embodiment, the attachment devices raise a substan 5A-5C. An insertion guide portion 520 is shoWn coupled to tial portion of the insertion guide device above the subject a ?rst portion 522. The insertion guide portion 520 is further surface. By raising the insertion guide device above the coupled to a second portion 530. The insertion guide portion subject surface, tissue damage due to pinching large 520 is further coupled to a base portion 510. A ?rst angular amounts of tissue under the insertion guide device is adjustment device is shoWn in FIG. 5A that permits rotation avoided. adjustment of an insertion aXis 502 along direction 524. A [0051] In one embodiment, the shape of the attachment second angular adjustment device is shoWn in FIG. 5B that device or devices further reduces tissue damage. In one permits rotation adjustment of an insertion aXis 502 along embodiment the truncated cone shape reduces a subject direction 526. contact surface to a minimum area Where suf?cient support [0056] In one embodiment, the portion of an insertion for the securing device such as a bone screW is provided, guide device 500 includes a locking device 540 that ?Xes While reducing the contact area. In one embodiment, a cone both the ?rst angular adjustment device and the second shape is desirable due to the use of a round cutting device to angular adjustment device concurrently When actuated. In pierce tissue on a subject’s scalp prior to attachment. In one one embodiment, the locking device 540 includes a gripping embodiment, a modi?ed hypodermic needle is used to pierce device 542 such as a knob. In one embodiment, the locking the scalp, thus making a round attachment device conve device 540 includes a threaded member 544 coupled to the nient. In one embodiment, a substantially linear contact gripping device 542. In one embodiment, the threaded surface is desirable due to the use of a linear cutting member 544 passes through a slot 548 in the ?rst portion instrument to pierce tissue on a subject’s scalp prior to 522, alloWing the ?rst portion to move along direction 524 attachment. In one embodiment, a scalpel is used to pierce With respect to the body portion 510. In one embodiment, the the scalp, thus making a substantially linear contact surface locking device 540 includes a base contacting portion 546. of an attachment device convenient. [0057] In operation, the embodiment shoWn in FIGS. [0052] FIG. 4 shoWs one embodiment of a centering 5A-5C ?Xes an orientation of the insertion aXis 502 in device 470 similar to the embodiment illustrated in FIG. 2. multiple degrees of freedom concurrently by tightening the The device con?guration and use of a centering device is threaded member 544 With the gripping portion 542. The not, hoWever, limited to the embodiment illustrated in FIG. threaded member in turn tightens the base contacting portion 2. The centering device 470 includes an insertion aXis 472, 546 against the base 510. This tightening motion pulls the a ?rst diameter portion 474 and a second diameter portion base 510; the ?rst portion 522, and the second portion 530 476. In one embodiment, the ?rst diameter portion 474 together, substantially ?Xing their respective locations. forms a close tolerance ?t Within an insertion guide portion so that the insertion aXis 472 can be adjusted using adjust [0058] Using one locking device 540 to ?X multiple able features of the insertion guide device embodiments as adjustment devices is desirable in one embodiment because described above. In one embodiment, the second diameter it alloWs a surgeon to quickly and easily secure all move portion 476 forms a close tolerance ?t Within an opening in ment of an insertion aXis 502 in a single locking operation a subject such as a burr hole. In one embodiment, the second once a desired orientation is found. Atradeoff is also present, diameter portion 476 ?ts inside an irregular opening in a in that during some operations, precise adjustment requires subject such as a burr hole to effectively ?nd an approximate that each degree of freedom, or angular adjustment is center of an irregular opening. focused on independently. When independent focus on each degree of freedom is necessary, individual angular adjust [0053] In a surgical procedure, such as neurosurgery, after ment and individual locking devices are desirable. installation of an insertion guide device, an insertion point may not be aligned over the center of a round burr hole, or [0059] An additional embodiment is shoWn in FIGS. the effective center of an irregular burr hole. In one embodi 5D-F. FIG. 5D shoWs a portion of an insertion guide device US 2004/0122446 A1 Jun. 24, 2004

550. In one embodiment, attachment devices and insertion includes a mating portion 622 that engages the upper secur point adjustment devices as described above are used in ing portion 616 of the securing device 610. In one embodi conjunction With embodiments described in FIGS. 5D-5F. ment, the mating portion 622 includes a mating threaded An insertion guide portion 551 is shoWn coupled to a ?rst portion. Also shoWn is a holding region 624 such as a portion 552. The insertion guide portion 551 is further groove. coupled to a second portion 560. The insertion guide portion [0066] FIG. 6B shoWs an embodiment of a portion of a 551 is further coupled to a base portion 570. A ?rst angular ?ducial marker 650. A subject securing device 652, such as adjustment device is shoWn in FIG. 5D that permits rotation adjustment of an insertion aXis 503 along direction 554. A a more conventional bone screW, is shoWn attaching an interchange portion 654 to a subject surface. Similar to FIG. second angular adjustment device is shoWn in FIG. 5D that permits rotation adjustment of an insertion aXis 503 along 6A, a holding region 656 such as a groove is shoWn coupled to the interchange portion 654. In one embodiment, the use direction 556. of a more conventional bone screW is more cost effective in [0060] In one embodiment, the portion of an insertion manufacturing of the portion of the ?ducial marker 650. guide device 551 includes a locking device 580 that ?xes both the ?rst angular adjustment device and the second [0067] FIG. 6C shoWs an interchangeable indicator 630. angular adjustment device concurrently When actuated. In The interchangeable indicator 630 includes an upper portion one embodiment, the locking device 580 includes a gripping 634 that functions to indicate a point location in a medical device 582 such as a knob. In one embodiment, the locking imaging device such as a CT or MRI device, etc. In one device 580 includes a threaded member 584 coupled to the embodiment, the upper portion re?ects a selected Wave gripping device 582. In one embodiment, the threaded length of light that in turn indicates a position of a portion member 584 passes through a slot 588 in the ?rst portion of a subject, using a detection device. A mating portion 632 552, alloWing the ?rst portion 552 to move along direction is further shoWn attached to the upper portion 634. The 554 With respect to the body portion 570. In one embodi mating portion 632 is adapted to be removably positioned ment, the locking device 580 includes a base contacting Within a holding region such as the holding regions 624 and portion 586. 656 described above. [0061] In operation, the embodiment shoWn in FIGS. [0068] FIG. 6D shoWs an adaptor device 640 for use With 5D-5F ?Xes an orientation of the insertion aXis 503 in embodiments of the insertion guide device as described multiple degrees of freedom concurrently by tightening the above. In one embodiment, the interchangeable indicator threaded member 584 With the gripping portion 582. The 630 is adapted to be removed after initial subject imaging is threaded member in turn tightens the base contacting portion complete. The adaptor device 640 may then be inserted into 586 against the base 570. This tightening motion pulls the an embodiment of the ?ducial markers or portions of ?ducial base 570; the ?rst portion 552, and the second portion 560 markers as described above. In one embodiment, the inser together, substantially ?xing their respective locations. tion guide device is then directly mountable to the ?ducial [0062] In one embodiment, the portion of an insertion markers or portions of ?ducial markers Without additional guide device 551 includes a second locking device 590 that attachments needed. Tissue damage, as discussed above, is ?Xes both the ?rst angular adjustment device and the second reduced using this con?guration, as Well as increased tar angular adjustment device concurrently When actuated. In geting accuracy due to the use of the eXact ?ducial locations one embodiment, the locking device 590 includes a gripping to mount the insertion guide device. device 592 such as a knob. In one embodiment, the locking [0069] In one embodiment, the adaptor device 640 device 590 includes a threaded member 594 coupled to the includes an upper portion 644 With a receiving portion 646. gripping device 592. In one embodiment, the threaded The receiving portion is adapted to couple With attachment member 594 passes through a slot 598 in the ?rst portion devices of insertion guide devices as described above. In one 552, alloWing the ?rst portion 552 to move along direction embodiment, the receiving portion includes a groove, 554 With respect to the body portion 570. In one embodi although the invention is not so limited. Although an adaptor ment, the locking device 590 includes a base contacting device is shoWn in FIG. 6D for use in coupling an insertion portion 596. guide device to a number of ?ducial markers or portions of [0063] One advantage of designs shoWn in FIGS. 5D-F a number of ?ducial markers, the invention is not so limited. includes the ability to quickly and easily secure all move The insertion guide device may also be directly attached to ment of an insertion aXis 503 in a single locking operation a number of ?ducial markers or portions of a number of once a desired orientation is found. An additional locking ?ducial markers directly Without use of an adaptor device. device, such as locking device 590 provides eXtra security that the degrees of freedom of the insertion guide device 551 [0070] FIG. 7 shoWs an embodiment of an insertion guide device 700. The insertion guide device 700 includes a base Will not accidentally move out of the selected alignment. unit 710, and an insertion guide portion 720 coupled to the [0064] FIGS. 6A-6D shoW a number of embodiments of base unit 710. The insertion guide portion 720 determines an ?ducial markers and portions of ?ducial markers according insertion aXis similar to embodiments shoWn above. A to embodiments of the invention. In FIG. 6A, a securing number of attachment devices 730 are also shoWn coupled device 610 is shoWn With a subject securing portion 612, a to the base unit 710. The attachment devices 730 are coupled transition portion 614, and an upper securing portion 616. In to the base unit 710 through a number of insertion point one embodiment, the subject securing portion includes a adjustment devices 740. In one embodiment, the insertion bone screW portion. In one embodiment, the upper securing point adjustment devices 740 include a split clamping por portion includes a threaded portion. tion 741 and a screW 742. The insertion point adjustment [0065] An interchange portion 620 is also shoWn in FIG. devices 740 alloW the base unit 710 to be adjusted With 6A. In one embodiment, the interchange portion 620 respect to the attachment devices 730 similar to embodi US 2004/0122446 A1 Jun. 24, 2004

ments discussed above. In one embodiment an insertion mines an insertion aXis 802 similar to embodiments shoWn point adjustment device 740 is included for each attachment above. A number of attachment devices 830 are also shoWn device 730. In one embodiment, the insertion guide device coupled to the base unit 810. In one embodiment, the 700 includes three attachment devices 730 and three inser attachment devices 830 include a bone screW 832. The tion point adjustment devices 740. By adjusting at least one attachment devices 830 are coupled to the base unit 810 insertion point adjustment devices 740, an insertion point through a number of insertion point adjustment devices 840. (not shoWn) is translated through at least one degree of In one embodiment, the insertion point adjustment devices translational freedom to a selected location Within the sub 840 include a split clamping portion and a screW 842. ject surface. [0076] The insertion point adjustment devices 840 alloW [0071] FIG. 7 also shoWs a ?rst angular adjustment device the base unit 810 to be adjusted With respect to the attach 750 for adjusting a ?rst rotational degree of freedom. The ment devices 830 similar to embodiments discussed above. ?rst angular adjustment device 750 permits rotation of a In one embodiment, the insertion point adjustment devices component of the insertion aXis about a ?rst rotational aXis. 840 alloW the base unit 810 to be adjusted With respect to the In one embodiment, the ?rst rotational aXis is substantially attachment devices 830 substantially along direction 844. In tangent to the subject surface at the insertion point. In one one embodiment an insertion point adjustment device 840 is embodiment, at least one rail 752 guides the insertion guide included for each attachment device 830. In one embodi portion 720 along the ?rst rotational degree of freedom. A ment, the insertion guide device 800 includes three attach locking device 754 is shoWn to secure an orientation of the ment devices 830 and three insertion point adjustment insertion aXis in the ?rst rotational degree of freedom as devices 840. selected. In one embodiment, the locking device includes at least one set screW. [0077] By adjusting at least one insertion point adjustment device 840, an insertion point 804 is translated through at [0072] FIG. 7 also shoWs a second angular adjustment least one degree of translational freedom to a selected device 760 for adjusting a second rotational degree of location Within the subject surface. In one embodiment, the freedom. The second angular adjustment device 760 permits insertion point 804 is adjustable in both an X-aXis and a rotation of a component of the insertion aXis about a second Y-aXis as shoWn by coordinate aXes 806. rotational aXis. In one embodiment, the second rotational aXis is substantially tangent to the subject surface at the [0078] In one embodiment, the insertion guide device 800 insertion point. In one embodiment, at least one rail 762 does not include any adjustment about rotational degrees of guides the insertion guide portion 720 along the second freedom as described above. In one embodiment, an orien rotational degree of freedom. A locking device 764 is shoWn tation of the insertion aXis 802 is pre-determined upon to secure an orientation of the insertion aXis in the ?rst fabrication of the body 810 and the insertion guide portion rotational degree of freedom as selected. In one embodi 820. In one embodiment, the insertion guide device 800 is ment, the locking device includes at least one set screW. custom fabricated using stereolithography rapid prototyping or other suitable custom fabrication techniques. [0073] FIG. 7 also shoWs a third angular adjustment device 716 for adjusting a third rotational degree of freedom. [0079] FIG. 9 shoWs a How diagram of one method of The third angular adjustment device 716 permits rotation of aligning an insertion guide using embodiments of the inven a component of the insertion aXis about a third rotational tion as described above. As shoWn in FIG. 9, ?ducial aXis. In one embodiment, the third rotational aXis is sub markers are ?rst installed on a subject, such as a surgical stantially normal to the subject surface at the insertion point. patient. The subject is then imaged using imaging techniques In one embodiment, a rotating body portion 712 is alloWed as described above, such as CT or MRI techniques, etc. An to rotate With respect to the body 710. A locking device 714 image is generated of the subject With tissue shoWn in is shoWn to secure an orientation of the insertion aXis in the relation to the ?ducial markers, Which are concurrently third rotational degree of freedom as selected. In one imaged using the selected imaging technique. The target embodiment, the locking device includes at least one set location Within the subject is determined, and a trajectory is screW. computed betWeen a location external to the subject, to the target location. [0074] In one embodiment, the insertion guide portion 720 includes a locking device 722. In one embodiment the [0080] An embodiment of an insertion guide device is then locking device 722 includes a knob attached to a threaded adjusted using degrees of freedom as described in embodi portion that bears doWn against a back plate 724. In one ments above, to substantially coincide With the computed embodiment at least tWo of the rotational degrees of freedom trajectory in relation to the ?ducial markers. In one embodi of the insertion guide device 700 can be concurrently ?Xed ment, attachment devices and corresponding insertion point using the locking device 722. In one embodiment, the ?rst adjustment devices are asymmetrically spaced about a cir rotational degree of freedom and the second rotational cumference of the base unit of the insertion guide device to degree of freedom can be concurrently ?Xed using the provide easy orientation of the insertion guide on the ?ducial locking device 722. FIG. 7 shoWs an embodiment Where the markers. rails 752 and rails 762 are ?Xed betWeen the locking device 722 and the back plate 724 upon actuation of the locking [0081] The insertion guide device is then attached to the device 722. ?ducial markers in a state of substantial alignment With the desired trajectory as determined by imaging. One advantage [0075] FIG. 8 shoWs one embodiment of an insertion of a method as described above, is that substantial alignment guide device 800. The insertion guide device 800 includes a of the insertion guide is possible Without the subject being base unit 810, and an insertion guide portion 820 coupled to present. This alloWs time in the operating room to be the base unit 810. The insertion guide portion 820 deter reduced. Optionally, alignment of the insertion guide can be US 2004/0122446 A1 Jun. 24, 2004

performed on the subject. Although substantial alignment of should be determined With reference to the appended claims, the insertion guide device can be accomplished Without the along With the full scope of equivalents to Which such claims subject being present, it is sometimes necessary to perform are entitled. ?ne adjustment With the insertion guide device attached on the subject. As described previously, variations in mounting What is claimed is: an insertion guide device or opening a burr hole can make 1. An insertion guide device, comprising: ?ne adjustments necessary. a base unit; [0082] Although particular orders of operations in the an insertion guide portion coupled to the base unit, the method described above are discussed, one of ordinary skill insertion guide portion having a guide aXis that inter in the art, With the bene?t of the present speci?cation Will sects a subject surface at an insertion point; recogniZe that other orders of operation are possible Without departing from the invention. at least one attachment device coupled to the base unit, the attachment device adapted for attachment to a subject; CONCLUSION and an insertion point adjustment device coupled betWeen the [0083] Thus, an insertion guide has been shoWn that includes at least one insertion point adjustment device. base unit and the subject, Wherein a location of the Using embodiments of an insertion guide device as insertion point is adjustable Within the subject surface. 2. The insertion guide device of claim 1, Wherein a ?rst described above, a user such as a surgeon is able to adjust a angle of the guide aXis is adjustable about a ?rst aXis that lateral position of an insertion point to more precisely center the insertion point Within an opening in a subject, such as a passes through the insertion point. burr hole. Selected embodiments described above further 3. The insertion guide device of claim 2, Wherein a second angle of the guide aXis is adjustable about a second aXis that include a centering guide that easily indicates to a user When the insertion point is substantially centered Within the open passes through the insertion point. ing in the subject. 4. The insertion guide device of claim 3, Wherein the ?rst aXis is substantially normal to the subject surface at the [0084] Selected embodiments described above further insertion point. include adjustments of rotational degrees of freedom of an 5. The insertion guide device of claim 4, Wherein the insertion aXis. These adjustments alloW a user to align the second aXis is substantially tangent to the ?rst aXis at the insertion aXis With a target location Within a subject, Without insertion point. changing the lateral (translational) location of the insertion 6. The insertion guide device of claim 5, further including point. Selected embodiments described above permit a user a locking device that ?Xes an orientation of the guide aXis to ?X multiple degrees of rotational freedom using a single about both the ?rst aXis and the second aXis concurrently. locking device. 7. The insertion guide device of claim 3, Wherein the ?rst [0085] Selected embodiments described above further aXis is substantially tangent to the subject surface at the include the ability to attach an insertion guide device to at insertion point. least one eXisting ?ducial marker. The ability to attach to a 8. The insertion guide device of claim 7, Wherein the ?ducial marker improves accuracy of the insertion guide second aXis is substantially normal to the ?rst aXis at the device by aligning more precisely With imaged locations on insertion point, and substantially tangent to the subject a subject, and tissue damage or other attachment surface surface at the insertion point. damage is reduced by eliminating a separate attachment 9. The insertion guide device of claim 8, Wherein an procedure for the insertion guide device, apart from the orientation of the ?rst aXis and second aXis is further attachment of the ?ducial markers. adjustable about a third aXis normal to the subject surface at the insertion point. [0086] Selected embodiments described above further 10. The insertion guide device of claim 1, Wherein the at include attachment of a large percentage of an insertion least one attachment device is adapted to attach to a ?ducial guide device at a distance above a subject surface. Reducing marker support. a contact surface area reduces tissue damage or other attach 11. The insertion guide device of claim 1, Wherein the at ment surface damage due to an attachment procedure. least one attachment device spaces a majority of the inser Embodiments utiliZing substantially transparent materials tion guide device a distance above the subject surface. increase vieWability of an opening in a subject. 12. The insertion guide device of claim 11, Wherein the at [0087] Although speci?c embodiments have been illus least one attachment device contacts the subject along a line. trated and described herein, it Will be appreciated by those 13. The insertion guide device of claim 11, Wherein the at of ordinary skill in the art that any arrangement Which is least one attachment device contacts the subject at a trun calculated to achieve the same purpose may be substituted cated cone portion. for the speci?c embodiment shoWn. This application is 14. The insertion guide device of claim 1, Wherein at least intended to cover any adaptations or variations of the present a portion of the insertion guide device includes a substan invention. It is to be understood that the above description tially transparent material. is intended to be illustrative, and not restrictive. Combina 15. An insertion guide device, comprising: tions of the above embodiments, and other embodiments a base unit; Will be apparent to those of skill in the art upon revieWing the above description. The scope of the invention includes an insertion guide portion coupled to the base unit, the any other applications in Which the above structures and insertion guide portion having a guide aXis that inter fabrication methods are used. The scope of the invention sects a subject surface at an insertion point; US 2004/0122446 A1 Jun. 24, 2004

at least one attachment device coupled to the base unit, the adjusting an insertion point adjustment device coupled attachment device adapted for attachment to a subject; betWeen the base unit and the subject, to select a and location of the insertion point Within the subject sur face. an insertion point adjustment device coupled betWeen the 24. The method of claim 23, further including: base unit and the subject, Wherein a location of the insertion point is adjustable Within the subject surface; adjusting a ?rst angle of the guide aXis about a ?rst aXis and that passes through the insertion point; and a centering guide that indicates When the insertion point adjusting a second angle of the guide aXis about a second is substantially centered Within an opening in a subject. aXis that passes through the insertion point. 16. The insertion guide device of claim 15, Wherein the 25. The method of claim 24, further including ?xing the centering guide includes: ?rst angle of the guide aXis and the second angle of the guide aXis concurrently. a ?rst diameter portion having a close tolerance ?t With 26. The method of claim 23, further including centering the insertion guide portion; and the insertion guide portion using a centering guide Wherein a second diameter portion having a close tolerance ?t With the centering guide indicates When the insertion point is a dimension of the opening in the subject. substantially centered Within an opening in a subject. 17. The insertion guide device of claim 15, further includ 27. The method of claim 26, Wherein centering the ing: insertion guide portion includes: a ?rst adjustment device Wherein a ?rst angle of the guide coupling a ?rst diameter portion of the centering guide to aXis is adjustable about a ?rst aXis that passes through the insertion guide, the ?rst diameter portion having a the insertion point; and close tolerance ?t With the insertion guide portion; a second adjustment device Wherein a second angle of the adjusting the insertion point adjustment device to an guide aXis is adjustable about a second aXis that passes orientation Where a ?rst diameter portion of the cen through the insertion point. tering guide ?ts at least partially Within the opening in the subject, the ?rst diameter portion having a close 18. The insertion guide device of claim 15, Wherein the at tolerance ?t With a dimension of the opening in the least one attachment device spaces a majority of the inser tion guide device a distance above the subject surface. subject. 28. Amethod of manufacturing an insertion guide device, 19. The insertion guide device of claim 18, Wherein the at comprising: least one attachment device contacts the subject along a line. 20. The insertion guide device of claim 18, Wherein the at forming a base unit; least one attachment device contacts the subject at a trun coupling an insertion guide portion to the base unit, the cated cone portion. insertion guide portion having a guide aXis that inter 21. An insertion guide device, comprising: sects a subject surface at an insertion point; a base unit; coupling at least one attachment device to the base unit, an insertion guide portion coupled to the base unit, the the attachment device adapted for attachment to a insertion guide portion having a guide aXis that inter subject; and sects a subject surface at an insertion point; coupling an insertion point adjustment device betWeen the base unit and the subject, Wherein a location of the at least one attachment device coupled to the base unit, the insertion point is adjustable Within the subject surface. attachment device adapted for attachment to a subject; 29. The method of claim 28, further including: and forming a ?rst angle adjustment device, Wherein a ?rst a centering guide that indicates When the insertion point angle of the guide aXis is adjustable about a ?rst aXis is substantially centered Within an opening in a subject. that passes through the insertion point; and 22. The insertion guide device of claim 21, Wherein the centering guide includes: forming a second angle adjustment device, Wherein a second angle of the guide aXis is adjustable about a a ?rst diameter portion having a close tolerance ?t With second aXis that passes through the insertion point. the insertion guide portion; and 30. The method of claim 29, further including coupling a a second diameter portion having a close tolerance ?t With locking device to the ?rst angle adjustment device and to the a dimension of the opening in the subject. second angle adjustment device, Wherein the locking device 23. A method of aligning an insertion guide device, ?Xes the ?rst angle of the guide aXis and the second angle of comprising: the guide aXis concurrently. 31. The method of claim 28, further including coupling a providing a base unit; centering guide to insertion guide device Wherein the cen coupling an insertion guide portion to the base unit, the tering guide indicates When the insertion point is substan insertion guide portion having a guide aXis that inter tially centered Within an opening in a subject. 32. The method of claim 28, Wherein coupling at least one sects a subject surface at an insertion point; attachment device to the base unit includes coupling at least coupling at least one attachment device to the base unit, one attachment device to the base unit that spaces a majority the attachment device adapted for attachment to a of the insertion guide device a distance above the subject subject; and surface. US 2004/0122446 A1 Jun. 24, 2004

33. The method of claim 32, wherein coupling at least one coupling at least one attachment device to the base unit, attachment device to the base unit includes coupling at least the attachment device adapted for attachment to a one attachment device to the base unit that contacts the subject; subject along a line. 34. The method of claim 32, Wherein coupling at least one adjusting the guide aXis With respect to the base unit prior attachment device to the base unit includes coupling at least one attachment device to the base unit that contacts the to attaching the insertion guide device to the subject; subject at a truncated cone portion. and 35. A method of aligning an insertion guide device, comprising: adjusting an insertion point adjustment device coupled betWeen the base unit and the subject, to select a providing a base unit; location of the insertion point Within the subject sur coupling an insertion guide portion to the base unit, the face. insertion guide portion having a guide aXis that inter sects a subject surface at an insertion point;