US20230081692A1 - Flexible circuit sheet - Google Patents

Abstract

A surgical instrument is disclosed having an elongated body portion having a proximal end and a distal end. The body portion is formed from a plastically deformable material such that the body portion can be bent between the proximal and distal ends from a first configuration to a second bent configuration and maintains the bent configuration. A flexible circuit having at least a pair of lead wires disposed around the body portion. The pair of lead wires are configured to conform to the bent configuration of the body portion such that they do not break during bending of the body portion. A tracking device adapted to cooperate with a navigation system to track the distal end of the instrument is coupled to the flexible circuit.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. application Ser. No. 14/987,033 filed on Jan. 4, 2016, which is a continuation of U.S. application Ser. No. 13/751,032 filed on Jan. 25, 2013, which is a continuation-in-part of U.S. application Ser. No. 13/748,150 filed on Jan. 23, 2013, which is continuation-in-part of U.S. application Ser. No. 13/097,243 filed on Apr. 29, 2011, which claims the benefit of U.S. Provisional Patent Application No. 61/330,024 filed on Apr. 30, 2010. This application is a continuation of U.S. application Ser. No. 14/987,033 filed on Jan. 4, 2016, which is a continuation of U.S. application Ser. No. 13/751,032 filed on Jan. 25, 2013, which is also a continuation-in-part of U.S. application Ser. No. 12/400,951 filed on Mar. 10, 2009. The disclosures of the above applications are incorporated herein by reference.
FIELD
• The present disclosure relates generally to a flexible circuit sheet and, more particularly, a flexible circuit sheet for a surgical instrument.
BACKGROUND
• The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
• Surgical procedures can be performed on anatomies such as the human anatomy for providing a therapy to the anatomy. One area of surgery includes procedures performed on facial cavities of a patient such as on the ear, nose or throat (ENT). In such a procedure, a surgical instrument such as a suction device may be inserted into such a cavity to perform a procedure for example. Because the viewing angle of a surgeon at the area of interest can be obscured by the surrounding tissue of the cavity, the ability of a surgeon to effectively apply a therapy, such as a suction procedure, can be reduced. In some procedures, it may also be difficult to effectively guide the surgical instrument through various shaped cavities of the anatomy. In an effort to address this difficulty, instruments have been developed that include flexible elongated portions configured to be permanently flexible. While these flexible instruments can conform to internal cavities of the anatomy, they do not retain any specific configuration, such that they are generally not suitable for certain procedures, such as an ENT suction procedure.
• In navigation systems, instruments are provided with tracking devices. Sometimes, however, such tracking devices can be difficult to manipulate or cumbersome to couple to the instrument, especially instruments with the flexible elongated portions. For example, it can be difficult to electrically couple the tracking devices to associated lead wires relative to the flexible elongated portion. In other instances, the tracking devices can be positioned in a handle or proximal region of the instrument such that if the distal tip moves or is moved relative to the handle, the distal tip can no longer be accurately tracked.
SUMMARY
• This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
• A surgical instrument, according to the present teaching has an elongated body portion having a proximal end and a distal end. The body portion has an inner diameter defining a first internal flow passage between the proximal and distal ends, and is formed from a malleable metallic material such that the body portion can be bent between the proximal and distal ends from a first configuration to a second bent configuration and maintain the bent configuration. A handle portion coupled to the proximal end of the body portion and including a second internal passage in fluid communication with the first internal flow passage. A tracking device positioned adjacent the distal end and adapted to cooperate with a navigation system to track the location of a distal tip of the instrument, and including. A flexible circuit is disposed around the body portion from the tracking device to the handle portion, the flexible circuit configured to conform to the bent configuration of the body portion such that they do not strain or break during bending of the body portion.
• Further according to the present teachings, a surgical instrument is provided having of an elongated body portion having a proximal end and a distal end. A tracking device is coupled to the elongated tubular body portion adjacent to the distal end. The tracking device is adapted to cooperate with a navigation system and includes a flexible circuit disposed about the tubular body portion between the proximal and distal ends.
• 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 teachings.
DRAWINGS
• The present teachings will become more fully understood from the detailed description, the appended claims and the following drawings. The drawings are for illustrative purposes only of selected embodiments and not all possible limitations, and are not intended to limit the scope of the present disclosure.
• FIG.1 is a perspective view of an exemplary navigation system according to the principles of the present disclosure;
• FIG.2 is a top plan view of an exemplary malleable suction instrument for use with the navigation system according to the principles of the present disclosure;
• FIG.3 is a side view of the exemplary suction instrument according to the principles of the present disclosure;
• FIG.4 is a partial perspective view of a distal region of the exemplary suction instrument having an exemplary flexible circuit sheet according to the principles of the present disclosure;
• FIG.5 is a partial side view of the distal region of the exemplary suction instrument associated with the exemplary flexible circuit sheet according to the principles of the present disclosure;
• FIG.5A is an exploded view of an exemplary wire routing configuration according to the principles of the present disclosure;
• FIG.6 is a partial sectional view of the exemplary suction instrument ofFIG.5 according to the principles of the present disclosure;
• FIG.7 is a partial view of a handle portion of the exemplary suction instrument according to the principles of the present disclosure;
• FIGS.8 and9 illustrate views of exemplary alternative tracking sensor configurations according to the principles of the present disclosure;
• FIG.10 is a view of exemplary bent or formed configurations of the exemplary malleable suction instrument according to the principles of the present disclosure;
• FIG.11 is a partial perspective view of the distal region of the exemplary suction instrument illustrating an exemplary alternative tracking arrangement associated with the exemplary flexible circuit sheet according to the principles of the present disclosure;
• FIG.12 is a partial perspective view of the distal region of the exemplary suction instrument illustrating another exemplary alternative tracking arrangement according to the principles of the present disclosure;
• FIG.13A is an exploded perspective view of an exemplary configuration of the flexible printed circuit sheet according to the principles of the present disclosure;
• FIG.13B is a perspective view of the flexible printed circuit sheet ofFIG.13A in an exemplary assembled configuration according to the principles of the present disclosure;
• FIG.14 is a perspective view of another exemplary flexible printed circuit sheet according to the principles of the present disclosure;
• FIG.15 is a perspective view illustrating the flexible printed circuit sheet ofFIG.14 in a bent or flexed condition according to the principles of the present disclosure;
• FIG.16 is a perspective view of the flexible printed circuit sheet ofFIGS.14 and15 in a flexed condition conforming to an outer surface of an exemplary instrument according to the principles of the present disclosure;
• FIG.17 is a partial side view of the distal region of the exemplary suction instrument ofFIG.5 associated with the exemplary flexible circuit sheet and having wire management channels according to the principles of the present disclosure;
• FIG.18 is a perspective view of a patient tracking device having an exemplary flexible printed circuit sheet and associated coils according to the principles of the present disclosure;
• FIG.19 is a top view of another exemplary flexible printed sheet according to the principles of the present disclosure;
• FIGS.20A-20C are side views representing various exemplary configurations of the flexible printed circuit sheet ofFIG.19 according to the principles of the present disclosure;
• FIG.21 is a top plane view of an exemplary surgical instrument for use with a navigation system according to the principles of the present disclosure;
• FIG.22 represents a top view of traces associated with the flexible circuit sheet ofFIG.23B;
• FIG.23A represents a malleable suction tube shown inFIG.21;
• FIG.23B represents a conformed flexible circuit shown inFIG.22A;
• FIGS.24A-240 represent perspective views of these exemplary configurations of a flexible circuit sheet according to the present disclosure; and
• FIGS.25 and26 represent cross-sectional views of the flexible circuit sheet shown inFIGS.24A through240.
DESCRIPTION OF THE VARIOUS EMBODIMENTS
• The following description is merely exemplary in nature and is not intended to limit the present disclosure, its application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features with the various elements in each view being drawn to scale. Although the following description is related generally to a flexible circuit sheet operatively associated with an exemplary flexible or malleable suction instrument, it will be appreciated that the flexible circuit sheet can be associated with various devices and/or instruments, including various other surgical instruments.
• Various exemplary embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, systems and/or methods, to provide a thorough understanding of exemplary embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that exemplary embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
• FIG.1 is a diagram schematically illustrating an overview of an image-guidednavigation system10 for use in the non-line-of-site navigating of asurgical instrument100, such as a navigable malleable suction device or suction instrument, according to various exemplary embodiments of the present disclosure. Exemplary navigation systems include those disclosed in U.S. Pat. No. 7,366,562, issued on Apr. 29, 2008 to John H. Dukesherer et al. and U.S. Pat. App. Pub No. 2008/0132909, published Jun. 5, 2008, to Bradley A. Jascob et al., both incorporated herein by reference. Commercial navigation systems include the StealthStation® AxiEM™ Surgical Navigation System sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colo., USA. It should be appreciated that while thenavigation system10 andsuction instrument100 are generally described in connection with an ear, nose and throat (ENT) procedure,navigation system10 andsuction instrument100 can be used in various other appropriate procedures.
• Generally, thenavigation system10 can be used to track a location of anexemplary suction instrument100, including a distal tip or end thereof, that includes an exemplary flexible printedcircuit sheet232 associated therewith, as will be described herein.Navigation system10 can generally include anoptional imaging system20, such as a fluoroscopic X-ray imaging device configured as a C-arm24 and animage device controller28. The C-arm imaging system20 can be any appropriate imaging system, such as a digital or CCD camera, which are well understood in the art. Image data obtained can be stored in the C-arm controller28 and sent to a navigation computer and/or processor controller orwork station32 having adisplay device36 to displayimage data40 and auser interface44. Thework station32 can also include or be connected to an image processor, navigation processor, and a memory to hold instruction and data. Thework station32 can include an optimization processor that assists in a navigated procedure. It will also be understood that the image data is not necessarily first retained in thecontroller28, but may also be directly transmitted to theworkstation32. 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 thework station32.
• Thework station32 provides facilities for displaying theimage data40 as an image on thedisplay device36, saving, digitally manipulating, or printing a hard copy image of the received image data. Theuser interface44, which may be a keyboard, mouse, touch pen, touch screen or other suitable device, allows a physician oruser50 to provide inputs to control theimaging device20, via the C-arm controller28, or adjust the display settings of thedisplay device36.
• With continuing reference toFIG.1, thenavigation system10 can further include a tracking system, such as an electromagnetic (EM) trackingsystem60. The discussion of theEM tracking system60 can be understood to relate to any appropriate tracking system. TheEM tracking system60 can include a localizer, such as acoil array64 and/orsecond coil array68, acoil array controller72, anavigation probe interface80, and thetrackable suction instrument100.Instrument100 can include an instrument tracking device ordevices84, as will be discussed herein. Briefly, thetracking device84 can include an electromagnetic coil to sense a field produced by the localizingcoil arrays64,68 and provide information to thenavigation system10 to determine a location of thetracking device84. Thenavigation system10 can then determine a position of a distal tip of thesuction instrument100 to allow for navigation relative to thepatient34 and patient space.
• TheEM tracking system60 can use thecoil arrays64,68 to create an electromagnetic field used for navigation. Thecoil arrays64,68 can include a plurality of coils that are each operable to generate distinct electromagnetic fields into the navigation region of thepatient34, which is sometimes referred to as patient space. Representative electromagnetic systems are set forth in U.S. Pat. No. 5,913,820, entitled “Position Location System,” issued Jun. 22, 1999 and U.S. Pat. No. 5,592,939, entitled “Method and System for Navigating a Catheter Probe,” issued Jan. 14, 1997, each of which are hereby incorporated by reference.
• Thecoil arrays64,68 can be controlled or driven by thecoil array controller72. Thecoil array controller72 can drive each coil in thecoil arrays64,68 in a time division multiplex or a frequency division multiplex manner. In this regard, each coil may be driven separately at a distinct time or all of the coils may be driven simultaneously with each being driven by a different frequency.
• Upon driving the coils in thecoil arrays64,68 with thecoil array controller72, electromagnetic fields are generated within thepatient34 in the area where the medical procedure is being performed, which is again sometimes referred to as patient space. The electromagnetic fields generated in the patient space induce currents in thetracking device84 positioned on or in thesuction instrument100. These induced signals from thetracking device84 can be delivered to thenavigation probe interface80 and subsequently forwarded to theprocessor32. Thenavigation probe interface80 can also include amplifiers, filters and buffers to directly interface with thetracking device84 in theinstrument100. Alternatively, thetracking device84, or any other appropriate portion, may employ a wireless communications channel, such as that disclosed in U.S. Pat. No. 6,474,341, entitled “Surgical Communication Power System,” issued Nov. 5, 2002, herein incorporated by reference, as opposed to being coupled directly to thenavigation probe interface80.
• Thetracking system60, if it is using an electromagnetic tracking assembly, essentially works by positioning thecoil arrays64,68 adjacent to the patient32 to generate an electromagnetic field, which can be low energy, and generally referred to as a navigation field. Because every point in the navigation field or patient space is associated with a unique field strength and directions, theelectromagnetic tracking system60 can determine the position of theinstrument100 by measuring the field strength and directions or components thereof at thetracking device84 location. Thecoil array controller72 can receive the induced signals from thetracking device84 and transmit information regarding a location, where location information can include both x, y, and z position and roll, pitch, and yaw orientation information, of thetracking device84 associated with the trackedsuction instrument100. Accordingly, six degree of freedom (6 DOF) information can be determined with thenavigation system10.
• Referring now toFIGS.2-10, the navigated malleablesurgical instrument100 will be described in greater detail. In one exemplary configuration, the malleablesurgical instrument100 can be used for suction, including fluid and tissue removal in ENT procedures. It should be appreciated, however, that the navigated malleablesurgical instrument100 can be used in various other surgical procedures as may be desired and can be provided in the form of a malleable or flexible endoscope, a malleable or flexible catheter, and/or a malleable cannula. Thus, while the following description continues with reference to a navigatedmalleable suction instrument100, the discussion is also applicable to the surgical instruments discussed above.
• Suction instrument100 can include atube assembly110, ahandle assembly114 and atracking sensor arrangement118.Suction instrument100 can be configured for a single use such that it would be disposed after such use. Thetube assembly110 can include a malleable elongatedtubular body126 and aninsert portion130. Thetubular body126 can include anouter diameter134 and aninner diameter138 and can have afirst end142 coupled to thehandle assembly114 and a secondopposite end148 configured to receiveinsert portion130, as shown inFIG.6. Thesecond end148 can include an internalannular recess152 having aninner diameter156 greater than theinner diameter138 of the remaining portion ofbody126, as also shown inFIG.6. The malleableelongated body126 can be formed from various aluminum alloys, such as AL 3003-O, various stainless steel alloys, such as 304 annealed, as well as various other materials including titanium, niobium, molybdenum, tantalum, nitinol, vinyl, and multi-lumen materials, such that it is malleable to facilitate being bent or formed into various configurations and retaining the bent or formed configuration, as will be discussed herein. Thebody126 can also be provided in various lengths and diameters, including 7, 9 and 12 French diameters.
• Theinsert portion130 can be configured to provide non-malleable support for at least the trackingsensor84.Insert portion130 can include anouter diameter160 substantially equal to theinner diameter156 ofannular recess152, and aninner diameter164 substantially equal to theinner diameter138 of malleableelongated body126, as also shown inFIG.6. In this manner, the substantially equalinner diameters138,164 can provide for a substantiallyconstant flow path166 for suction. It should be appreciated, however, that theinner diameters138,164 can also be provided with varying dimensions. Theinsert portion130 can also include an exemplary axial length of 10 to 15 mm, including 14 mm.Insert portion130 can include afirst end172 and a secondopposite end176. Thefirst end172 of theinsert portion130 can be received inannular recess152, as shown inFIG.6. Insert portion can include a rigid construction to facilitate receiving andhousing tracking device84, as will be described herein. In this manner,insert portion130 can be formed or manufactured from stainless steel or other biocompatible rigid materials such thatinsert portion130 is not malleable likeelongated body126. The insert portion can also include an exemplary axial length of approximately 10 mm.
• Insert portion130 can include asleeve190 received on an exterior thereof, as shown inFIGS.5 and6.Sleeve190 can include aninner diameter194 substantially equal to the outer diameter ofinsert portion130, and anouter diameter198 substantially equal to theouter diameter134 ofbody126. It should be appreciated thatsleeve190 can also be configured with different diameters relative tobody126.Sleeve190 can extend over a portion ofinsert130 from thefirst end172 of theinsert portion130 towards the second end, as shown inFIG.6. In one exemplary configuration,sleeve190 can extend from thefirst end172 and contact thefirst end142 ofbody126 when theinsert portion130 is coupled toannular recess152 ofbody126. In another exemplary configuration,sleeve190 can extend from thefirst end172 ofbody portion130 in a similar manner as discussed above, but can stop short of thefirst end142 ofbody126, as shown inFIG.6.Sleeve190 can be fixed to insertportion130, and insertportion130 can be fixed toannular recess152 with an appropriate adhesive.Sleeve190 can be formed of a polymeric material or other suitable materials.Sleeve190 can also include afirst end220 configured to substantially align with thesecond end176 ofinsert130. Thefirst end220 can include a rounded or chamfered blunt distal tip or endpart222 such that it can be placed against surrounding tissue during a suction procedure without cutting or damaging such tissue. In one exemplary configuration,end part222 can extend overinsert portion130 so as to prevent cutting or damaging tissue.
• With particular reference toFIGS.4 and5,sleeve190 can include a plurality of flattenedsections206 configured to facilitate receiving and supporting thetracking sensor arrangement118, as will be described herein. In one exemplary configuration,sleeve190 can include at least three flattenedsections206 configured to attachably receivetracking device84. In this configuration, thetracking device84 can include threecoil assemblies214, as will be described herein. Briefly, in one exemplary configuration, the threecoil assemblies214 can each include a cylindrical configuration as shown inFIGS.4 and5, having an overall axial length of approximately 1.5 mm to 2.7 mm, an overall diameter of approximately 0.3 to 0.6 mm, and a plurality of wire windings wound along a cylindrical base to form the cylindrical configuration. The plurality of windings can form thecoil assembly214 having the generally uniform cylindrical configuration, as generally shown inFIG.5. Each flattenedsection206 can include a slot ordepression218 formed therein and configured to receive acorresponding coil assembly214, as shown for example inFIGS.5 and6. Eachslot218 can be formed in the corresponding flattenedsection206 at a 35 to 75 degree angle, including a 55 degree angle, to alongitudinal axis208 of thetube assembly110. In one exemplary configuration, eachslot218 can be formed at a 55 degree angle tolongitudinal axis208, as shown inFIG.5. Each of the three flattenedsections206 can be positioned equidistantly or 120 degrees around a circumference ofsleeve190 so that the threecoil assemblies214 are therefore likewise positioned equidistantly around the circumference of sleeve90, as also generally shown inFIGS.4-6. It should be appreciated that the coil assemblies can also be coupled to the sleeve without the flattenedsections206, and can be aligned at different orientations relative to the longitudinal axis, including parallel thereto. In this regard, thesleeve190 can include an outer surface with a circular shape in cross-section configured to receive thecoil assemblies214.
• Thecoil assemblies214 can include three coil assemblies as described above that cooperate with thenavigation system10 such that 6 DOF tracking information can be determined. It should be appreciated, however, that twocoil assemblies214 could also be used in conjunction withnavigation system10 such that 6 DOF tracking information can also be determined. In a configuration where threecoil assemblies214 are utilized, two of the three coil assemblies can be positioned at an angle relative to thelongitudinal axis208 with the third coil assembly being positioned at an angle relative to thelongitudinal axis208 or parallel thereto. The threecoil assemblies214 can also each be positioned at an angle relative to each other. As discussed above, an exemplary angle of the threecoil assemblies214 relative to thelongitudinal axis208 can be 55 degrees, which also provides for optimal packaging and spacing of the coil assemblies circumferentially aroundsleeve190. It should be appreciated that while an angle of 55 degrees has been discussed, other angles could be utilized withcoil assemblies214 andinstrument100 as may be required. It should also be appreciated, as discussed above, that the coil assemblies could be positioned parallel or perpendicular to thelongitudinal axis208.
• In a configuration where trackingdevice84 includes twocoil assemblies214, the two coil assemblies can similarly be positioned equidistant or 180 degrees spaced around an outer perimeter ofsleeve190, as well as can each be positioned at an angle relative to each other and at an angle relative to thelongitudinal axis208 of thetube assembly110. In this configuration, the two coil assemblies can also cooperate withnavigation system10 such that 6 DOF tracking information can be determined. In one exemplary configuration, the twocoil assemblies214 can be positioned at an angle of about 35 to 75 degrees, including about 55 degrees relative tolongitudinal axis208 of the tube assembly210.
• With additional reference toFIGS.8 and9, twoexemplary coil assemblies214A and214B having alternative winding configurations are illustrated operatively associated with an exemplarytubular structure223 of an exemplary instrument.Coil assemblies214A and214B can each include an overall non-linear shape as compared to the overall cylindrical configuration ofcoils assemblies214 shown inFIG.5.Coil assembly214A can include a central arcuate depression orconcavity224 such that thedepression224 has a smaller outer diameter than opposed ends225 of the plurality of windings, as generally shown inFIG.8. The winding configuration ofcoil assembly214A can provide an ability to maximize an amount of coil windings on a base wire while working towards minimizing an overall outer dimension or size of an instrument. In this regard,coil assembly214A is shown inFIG.8 with thearcuate depression224 substantially conforming to anouter surface226 of thetubular structure223 such that the coil assembly orassemblies214A essentially nest around theouter surface226 of the tubular structure. In this regard, because of the general clearance provided by a cylindrical coil assembly positioned adjacent to an outer diameter of thetubular structure223, a gap or space221 on either end of the coil can include additional windings without effectively increasing the overall outer diameter of the entire assembly. This can allow for greater or stronger sensitivity in the navigated space.
• With particular reference toFIG.9,coil assembly214B can include an overall arcuateconvex shape227 configured to conform to and nest within aninner diameter229 of the exemplary tubular structure. Similar tocoil assembly214A, such a configuration can provide for maximizing an amount of windings on the base wire while also working towards minimizing theinner diameter229 of thetubular structure223 that would be required to receive one ormore coil assemblies214B.
• With particular reference toFIGS.5 and5A, the trackingsensor arrangement118 will now be described in detail.Tracking sensor arrangement118 can include thetracking device84 having the two or threecoil assemblies214, as well as a first set oflead wires228, the flexible printed circuit board orsheet232 and a second set oflead wires236. The first set oflead wires228 can include a pair oflead wires228A and228B for eachcoil assembly214, as generally shown inFIG.5. Each respective pair oflead wires228A and228B can be routed to a first end of a respective pair ofcircuit connections240 on flexible printedcircuit sheet232. As will be discussed in greater detail below, theflexible circuit sheet232 can facilitate improving the time and cost associating with terminating fine wires utilized in medical and other instruments while also providing the flexibility necessitated for such instruments. It should be appreciated that while trackingdevice84 is described as having three coil assemblies, more or less coil assemblies can be utilized as may be desired or required depending on, for example, characteristics of the navigation system being utilized as well as the number of degrees of freedom desired.
• The flexible printedcircuit sheet232 can include a flexible backing orbase layer244 such that it can readily conform to the contour of an outer surface of thebody126, as shown for example inFIG.4. The flexible printedcircuit sheet232 can wrap entirely or partially around a perimeter of thebody126 and can be positioned adjacent thesecond end148 ofbody126, as generally shown inFIGS.5 and6. In this manner, theinsert portion130, in its inserted position shown inFIG.6, can be under all or substantially all of the flexible printedcircuit sheet232. Therigid insert portion130 can thus prevent themalleable body126 from bending or flexing in a region of the flexible printedcircuit sheet232. In one exemplary configuration, the flexible printedcircuit sheet232 can be an integral part ofsleeve190. In another exemplary configuration, flexible printedcircuit sheet232 can be positioned in a similar manner onsleeve190. In this configuration, flexible printedcircuit sheet232 can be positioned onsleeve190 betweencoil assemblies214 and the end ofsleeve190 adjacent thesecond end148 ofbody126.
• The second set of lead wires can include three respective pairs ofwires236A,236B,236C, as generally shown inFIG.5 with reference to the partial exploded view inFIG.5A. It should be appreciated that whileFIGS.2-5,6-7 and10 show the second set oflead wires236 as one element, this is for illustration purposes only and it should be understood that the second set of lead wires shown inFIGS.2-5,6-7 and10 include the three respective pairs oflead wires236A-C, as shown inFIG.5A. Each pair oflead wires236A-C can be twisted together and positioned adjacent each other, as also shown inFIG.5A. Thetwisted pairs236A-C of wires can reduce electrical interference or cross-talk between each pair of adjacent lead wires as well as minimize pickup from an associated electromagnetic navigation system. Each pair of lead wires can be connected to asingle coil assembly214 via the flexible printedcircuit sheet232. The lead wires can also include a Teflon coating or other appropriate lubricous or friction reducing coating on an outer surface thereof. Each pair oflead wires236A-C can be coupled to an opposite end ofrespective circuit pads240 on the flexible printedcircuit sheet232. It should be appreciated that thelead wires228 could alternatively extend up thebody126 as a twisted pair of lead wires without the use of the flexible printedcircuit sheet232, or could extend up to and be terminated directly to the respective twisted pair oflead wires236.
• The second set oflead wires236, which includes the three pairs oftwisted wires236A-C, can be helically wound aroundelongated body126 from the flexible printedcircuit sheet232 to thesecond end148, as generally shown for example inFIGS.3-5A. Thewires236 can be wound around the outside ofbody126 at an angle α relative to thelongitudinal axis208 of approximately 0 to 85 degrees, including about 30 degrees, as generally shown inFIGS.5 and5A. Each revolution of thewires236 aroundbody126 can be spaced apart from each other by a distance D of approximately 2 to 45 mm, including about 5 mm, as shown with reference toFIG.5. In one exemplary configuration, the range can include from about 15-45 mm. The helical winding of thewires236 at an acute angle relative to the longitudinal axis along with the relatively close spacing of the wires and the Teflon coating facilitate being able to bend themalleable body126 at significant angles, including beyond ninety degrees, without breaking or otherwise damaging thewires236, as will be discussed herein. It should be appreciated that thewires236 can also be positioned alongbody126 in a single revolution from the flexible printedcircuit sheet232 or thetracking device84 to thesecond end148. In this regard, the revolution spacing can be from about 2 mm to a length of thebody126. Thewires236 can also be positioned alongbody126 from the flexible printedcircuit sheet232 to thesecond end148 without being wound aroundbody126.
• Once the second set ofwires236 has been helically wound around the outside oftubular body126 to thefirst end142, the wires can be routed intoslots254 inhandle assembly114 and connected to respective lead wires of acable connector assembly258, as generally shown inFIG.7. Thecable connector assembly258 can be connected to thenavigation probe interface80, as generally shown inFIG.1. The handle assemble114 can include twohalf sections264, with one half section being shown inFIG.7 for illustration purposes.
• With particular reference toFIG.6 and continued reference toFIGS.2-5A,7 and10, thetube assembly110 can include a polymeric outer heat shrink272 covering the entire assembly, as shown in the cross-sectional view ofFIG.6. Thus, the heat shrink272 can cover theelongated body126, theinsert portion130, and thesensor arrangement118 including the wires helically wound along thebody126. The heat shrink272 can provide an outer covering or shell over thetube assembly110 andsensor arrangement118 while providing sufficient flexibility for both bending of thebody126 and slight relative movement of thehelically wound wires236 as a result of the bending. In this regard, the wires can be moveably captured between the heat shrink and the tubular body. The heat shrink covering can also serve as an electric isolation barrier. It should be appreciated that while the heat shrink covering is only shown inFIG.6, it has not been shown in the other various views for clarification purposes only to better illustrate thesensor arrangement118 and routing ofwires236. In this regard, it should be understood that the heat shrink272 can cover thetube assembly110 andsensor arrangement118 shown inFIGS.2-10.
• As discussed above, thehandle assembly114 can include multiple components, such as for example two halves, with one of the halves shown inFIG.7 receiving the first end of thesuction tube assembly110 in fluid communication with asuction passage280 formed therein. Thesuction passage280 can terminate at aconnector284 protruding from a proximal end of the handle (FIGS.2 and3) and can be configured to receive a suction hose or other arrangement in fluid communication with a suction source (not shown). Once the wires are connected to the cable assembly and routed in theslots254 as discussed above, the other half ofhandle assembly114 can connected and an adhesive can be used to bond the handle halves together to form the handle as shown inFIGS.2 and3.
• With particular reference toFIG.2, handleassembly114 can include asuction adjustment feature290 which can be in the form of abore292 extending from anouter surface294 of thehandle assembly114 and into fluid communication with thesuction passage280. In operation, a surgeon oruser50 of theinstrument100 can place their thumb or another object over thebore292 to vary an opening of thebore292 and thus vary an amount of suction pressure realized in the flow path orpassage166. For example, if thebore292 is left completely open or uncovered, a majority if not all of the suction will be through thebore292 and not thefirst end172 ofinsert portion130. On the other hand, if the bore192 is completely covered or closed off, a maximum amount of suction will be realized atend172. Varying the opening ofbore292 between fully closed and fully opened can therefore correspondingly vary an amount of realized suction atend172.
• In operation and with additional reference toFIG.10, the malleableelongated body126 can be bent into various configurations, as generally shown by the exemplary configurations300A-D. The malleable nature ofbody126 can provide the ability forbody126 to be bent into such various configurations without kinking and can maintain the various configurations until bent or shaped into another configuration. Further,malleable body126 can be bent or shaped as discussed above without require additional tools, such as a mandrel to facilitate the bending. This is advantageous, for example, in that a surgeon can bendbody126 multiple times by hand during a procedure in close proximity to the patient without having to resort to additional tools or other equipment to facilitate the bending while performing the procedure.
• Moreover, the helically wound configuration ofwires236 along with the Teflon coating provides for the ability to bendmalleable body126 at various angles including through ninety degrees without breaking the wires. More specifically, by windingwires236 helically aroundbody126 at an angle relative to the longitudinal axis and at a close proximity to each other, the wound wires can conform to the bent shape and move or flex axially with the bent tube such that they do not strain and/or break during the bending. In addition, the Teflon coating provides added lubricity for the wires to have relative motion between the tube and theouter shrink coating272 during bending.
• Further, by providing thetracking device84 near thedistal tip222, thedistal tip222 of the suction instrument can be tracked to provide substantially accurate position data for the distal tip ofsuction instrument100 when out of a line of sight in a body cavity ofpatient34. This is particularly useful for themalleable suction instrument100 because, for example, the tip can be bent or moved relative to the handle and still be tracked. On the other hand, if the tracking device was in the handle (such as in a hind tracked system) and thebody126 was subsequently bent or shaped, the navigation system would no longer be able to accurately track the position of the distal tip. In this regard, the present teaching provide a tip tracked malleable suction instrument that can be bent or shaped into various configurations as may be required during a procedure, and the distal tip can be accurately tracked in any of the various bent positions.
• In use, the patient34 can be positioned on an operating table or other appropriate structure and appropriate image data of a patient or navigation space can be obtained, such as an ENT area. The image data can be registered to the navigation space as is known in the art. Thesurgeon50 can determine a shape of themalleable suction instrument100 to reach a target site and bend thesuction instrument100 to the determined shape whereinstrument100 retains the bent shape, as discussed above. The bent or shapedsurgical instrument100 can then be guided to the target site with crosshairs representing the position of the distal tip ofinstrument100 being superimposed on the image data. The crosshairs can show the tracked relative position of the distal tip asinstrument100 is navigated to the target site. In addition, if during navigation of the shapedinstrument100 to the target site, the surgeon determines that the shaped configuration will need to be altered, the surgeon can bend and/or reshape theinstrument100 to a newly shaped configuration and proceed again as discussed above.
• With additional reference toFIG.11, an alternativetracking device arrangement84′ will now be discussed. As can be seen inFIG.11, trackingdevice84′ can include two or three wrappedcoil assemblies214′ that can be used in place of thecoil assemblies214.Coil assemblies214′ can be wrapped aroundsleeve190 proximate thedistal tip222. In one exemplary configuration, thecoil assemblies214′ can be individually wrapped aroundsleeve190 in an overlapping manner with a wrap axis having a non-normal and non-parallel angle tolongitudinal axis208. In the exemplary configuration illustrated,coil assemblies214′ can be wrapped aroundsleeve190 at an angle relative to each other andlongitudinal axis208. In another exemplary configuration,coil assemblies214′ can be wrapped aroundsleeve190 and spaced axially apart from each other. A further discussion of thecoil assemblies214′ can be found in U.S. application Ser. No. 12/770,181, filed on Apr. 29, 2010 and entitled “Method and Apparatus for Surgical Navigation”, the disclosure of which is incorporated by reference herein in its entirety.
• With additional reference toFIG.12, another alternativetracking device arrangement84″ is shown associated withinstrument100.Tracking device84″ can also be used in place of trackingdevice84 and can include a plurality ofoval coil assemblies214″ positioned aboutsleeve190 proximatedistal tip222. In one exemplary configuration, two to fourcoil assemblies214″ can be positioned aboutsleeve190 proximatedistal tip222. In the exemplary configuration illustrated, fourcoil assemblies214″ can be circumferentially spaced aroundsleeve190 proximatedistal tip222, and anaxial coil304 can be positioned proximally ofcoil assemblies214″, as shown inFIG.12. In one exemplary configuration, twooval coil assemblies214″ can be provided with theaxial coil304. The twocoil assemblies214″ can also include two pair ofcoil assemblies214″ provided with theaxial coil304.
• Thecoil assemblies214″ can be formed in various selected shapes, such as elliptical, circular, or oval. In one exemplary configuration, theaxial coil304 can be concentric with and wrapped around an outer surface ofsleeve190 orbody126, as shown inFIG.12. A further discussion ofcoil assemblies214″ andaxial coil304 can be found in U.S. application Ser. No. 13/016,740, filed on Jan. 28, 2011 and entitled “Method and Apparatus for Image-Based Navigation”, the disclosure of which is incorporated by reference herein in its entirety.
• Turning now toFIGS.13A-18, the flexible printedcircuit sheet232, including various exemplary configurations thereof, will now be discussed in greater detail. With particular reference toFIGS.13A-13B, one exemplary configuration of the flexible printedcircuit sheet232 is shown in both an exploded view (FIG.13A) and an assembled view (FIG.13B). Flexible printedcircuit sheet232 can include the flexible backing orbase layer244, one or more circuit or conductive traces, such as copper traces350, positioned on a first orupper side354 ofbase layer244,coupling pads358 associated withtraces350, and aninsulative layer362 formed over at least the copper traces350 and coupled tobase layer244. It will be appreciated that while copper traces350 are shown positioned onupper side354, the copper traces350 can also be positioned on an opposite lower side ofbase layer244. While the discussion will continue with reference to the conductive traces being copper traces350, the conductive traces can also be formed from metal, nickel, gold, or copper with nickel/gold plating.
• The flexible printedcircuit sheet232 can provide a mechanism for facilitating fine gauge wire termination of associated sensors or coils and lead wires, such aswires228 and236 ofexemplary suction instrument100. The flexible printedcircuit sheet232 can also enable manufacturing and design flexibility in connection with use ofcircuit sheet232 on instruments and other devices that are flexible and/or conformable. For example, conventional techniques for electrically terminating sensor wires to lead wires can include directly connecting the sensor wires to the lead wires via soldering. As can be appreciated, such a technique is very time and labor intensive considering that the sensor and lead wires can include 58 AWG wire with an outer diameter of approximately 0.01 mm. Indeed, such conventional techniques for soldering the sensor wires to the lead wires often require performing the process under a microscope or other magnifying apparatus, which can further drive cost and expense into the manufacturing process.
• As will also be discussed in greater detail below, the exemplary flexible circuit sheets discussed herein can provide for improved efficiency and cost reduction in terminating such fine gauge sensor and lead wires, especially for medical instruments having size or volume constraints and that also require flexibility or conformability. In this regard, thecoupling358 on theflexible circuit sheet232 can be orders of magnitude bigger than the outer diameter of the wires to be terminated, such as a 0.1 mm to 0.5 mm square pad, for example. In an exemplary configuration, thecoupling pads358 can have a large surface area for the wires to be terminated such that, for example, a primary linear dimension of thecoupling pads358 can be orders of magnitude bigger than the outer diameter of the wires to be terminated. In one exemplary configuration, the wires to be terminated can include an outer diameter of between approximately 0.03 mm to 0.05 mm. In an exemplary configuration, the wires to be terminated can include 58 AWG wire having an outer diameter of approximately 0.01 mm. This can, among other things, facilitate easier and more efficient termination of the fine gauge wire due to the larger size ofcoupling pads358.
• Thebase layer244 can be formed form various materials having appropriate insulative properties and appropriate material properties such thatbase layer244 is flexible and can conform to various surface geometries. For example, the base layer244 (as well as the assembled printed circuit sheet232) can conform to the outer tubular surface of themalleable suction instrument100. In one exemplary configuration, the flexible nature offlexible circuit sheet232 can facilitate movement withtube assembly110 of malleable instrument100 (e.g.,FIG.10) once adhered thereto. In one exemplary configuration, thebase layer244 can be formed from a polymeric material, including but not limited to, a polyimide. In the exemplary configuration illustrated inFIGS.13A-13B, thebase layer244 can include alength366 of approximately 7 mm and awidth370 of approximately 3 mm. It should be appreciated, however, that the size and shape ofbase layer244 can vary depending on a particular application.
• The copper traces350 can be positioned or printed in any desired orientation onbase layer244, including substantially perpendicular to alongitudinal axis374 ofbase layer244. The copper traces350 can similarly include varying lengths and widths depending on the particular configuration of flexible printedcircuit sheet232. In the exemplary configuration illustrated inFIGS.13A-13B, the copper traces350 can include a length of approximately 1.25-3.0 mm and a width of approximately 0.15 mm. The copper traces350 can include a thickness of approximately 0.01-0.04 mm.
• Thecoupling pads358 can be positioned or printed at ends of the copper traces350, as can be seen inFIGS.13A-13B. Thecoupling pads358 can be formed in any desired shape, including the square or substantiallysquare shape378 shown, for example, inFIGS.13A-13B. Thecoupling pads358 can also be formed to have varying dimensions, including a dimension or dimensions that is/are larger than a typical outer diameter of the wires that are to be coupled to the pads. As discussed above, such a greater dimension of thecoupling pads358 relative to the size of the wire can provide for easier soldering of the wires to thepads358 and thus reduce time and manufacturing complexity associated with building an instrument requiring termination of fine gauge wires.
• For example, theexemplary coupling pads358 shown inFIGS.13A-13B are square in shape and include a length and width of approximately 0.5 mm. Again, it should be appreciated that the length and width ofcoupling pads358 can vary depending on the particular application of flexible printedcircuit sheet232. Thecoupling pads358 can also be formed from copper and include a tinning material, such as tin/lead, nickel/gold and/or gold.
• Theinsulative layer362 can be positioned over the copper traces350 and coupled to thebase layer244 in any suitable manner that allows or does not inhibit the flexibility and conformability of theflexible circuit sheet232. In one exemplary configuration, theinsulative layer362 can be adhered to thebase layer244 and copper traces350 with an adhesive. Theinsulative layer362 can include a shape and/or width so as to cover or substantially cover the copper traces350 between thecoupling pads358 to insulate thetraces350 from external contact. Similar to thebase layer244, theinsulative layer362 can also be formed from a polymeric material, such as polyimide. In one exemplary configuration, theinsulative layer362 can be a photoimageable coverlay. As will be discussed in greater detail below, theinsulative layer362 can include a thickness that is less than a thickness of thebase layer244. In the exemplary configuration shown inFIGS.13A-13B, theinsulative layer362 can include a rectangular shape corresponding to the exemplary symmetrical positioning of the copper traces350 andcorresponding coupling pads358.
• To couple the flexible printedcircuit sheet232 to a structure, such as theexemplary instrument100, an adhesive364 can be used. It should be appreciated, however, that other means for securing theflexible circuit sheet232 to a structure can be used, so long as the means used does not inhibit the flexible nature of printedcircuit sheet232. In one exemplary configuration, the adhesive364 can be applied to a lower orsecond side384 ofbase layer244. In this regard, the second side ofbase layer244 can be substantially smooth. It should also be appreciated that the adhesive364 can also be applied to the structure in addition to or in lieu of being applied tobase layer244. In one exemplary configuration, the adhesive364 can include a medical grade pressure sensitive adhesive. In another exemplary configuration, the adhesive364 can include a medical grade liquid or gel adhesive.
• The exemplary flexible printedcircuit sheet232, in the exemplary assembled configuration shown inFIG.13B, can include a bound together oroverall thickness388 of between approximately 0.04-0.07 mm. In some exemplary embodiments, theoverall thickness388 can be only approximately 0.04 mm. Stated another way, the assembledbase layer244, circuit traces andpads350,358 and insulative layer263 can include anoverall thickness388 of approximately 0.05 mm. It should be appreciated, however, that such a thickness can vary to be smaller or larger depending on the particular application of the flexible printedcircuit sheet232. Use of the pressuresensitive adhesive364 can increase theoverall thickness388 by approximately 0.025 mm to 0.05 mm. Similarly, use of the gel or liquid adhesive can increase thethickness388 by only 0.01 mm. Thus, theoverall thickness388 of the flexible printedcircuit sheet232, in various different configurations, can vary from 0.04 mm (without adhesive364) to approximately 0.11 mm (with adhesive364). As discussed above, such aminimal thickness388 offlexible circuit sheet232 provides for not only flexibility and conformability of thecircuit sheet232, but also applicability of the flexible circuit sheets to medical and other devices and/or instruments that have very tight volume and/or packaging constraints.
• For example, one of ordinary skill in the art will appreciate that conventional printed circuit boards considered thin in the industry can include a thickness of 0.8 mm or greater and can be made from dielectric layers laminated together with epoxy resin prepreg. Such materials combined with such a thickness do not provide for the conventional circuit boards being flexible and thus they cannot conform to non-planar surfaces and/or flex such that they cannot be used with a flexible or malleable medical instrument. Further, such a thickness of 0.8 mm or greater can preclude use of conventional printed circuit boards in medical instruments or devices where maintaining a minimum thickness or overall height is a critical parameter.
• The verythin thickness388 of the exemplaryflexible circuit sheet232, together with the polyimide material construction, can provide for significant flexibility and/or conformability ofcircuit sheet232. In this regard, the exemplaryflexible circuit sheet232 having theoverall thickness388 and polyimide material construction can include a bend radius of approximately ten times thethickness388. Thus, for the exemplary configuration offlexible circuit sheet232 discussed herein, the bend radius can be approximately 0.4 mm to 0.7 mm depending on theoverall thickness388 of the flexible printedcircuit sheet232. Such a bend radius can provide for significant flexibility in conforming the flexible printed circuit sheet to or around tight radii associated with compact or low profile medical instruments or devices.
• With additional reference toFIGS.14-16, another exemplary flexible printedcircuit sheet232 will now be discussed and designated withreference numeral232A. Flexible printedcircuit sheet232A can include similar properties and thickness dimensions as discussed above forflexible circuit sheet232 such that like reference numerals refer to like features or components. Flexible printedcircuit sheet232A is shown having anexemplary custom shape392 configured for a particular medical instrument or device. In the exemplary configuration illustrated inFIGS.14-16, flexible printedcircuit sheet232A can include one ormore apertures396 configured to be positioned around and/or provide access tocorresponding coil assemblies214. The copper circuit traces350 can be printed in various patterns to accommodate theapertures396 andcustom shape392, as shown for example inFIG.14. It should be appreciated that while not shown for clarity purposes, theinsulative layer362 can be custom shaped to include appropriate cutouts and an appropriate shape to cover the copper traces350 while leaving thecoupling pads358 offlexible circuit sheet232A exposed.
• As can be seen inFIGS.15-16, the flexible printedcircuit sheet232A can be bent or flexed in various configurations to conform to various instrument or device shapes, such as the distal end of amalleable instrument100. In one exemplary configuration, the flexible printedcircuit sheet232A can wrap around or substantially around themalleable suction instrument100. The flexible printedcircuit sheet232A can also bend, flex or twist with themalleable suction instrument100 during use thereof. In this regard, the flexible printedcircuit sheet232A can flex three-dimensionally. In the exemplary configuration shown inFIG.16,flexible circuit sheet232A can be adhered to the outer surface of a component ofmalleable suction instrument100 using, for example, adhesive364. As discussed above, thelead wires236A can be electrically coupled, such as via soldering, to theappropriate coupling pads358 and thecoil assembly wires228 can be soldered to thecorresponding pads358, as also shown inFIG.16.
• Turning now toFIG.17, flexible printedcircuit sheet232 is shown adhered tomalleable suction instrument100A, which is substantially similar tomalleable suction instrument100 shown inFIG.5, except forchannels402 formed insleeve190.Channels402 can receive sensor orcoil wires228 and provide a predetermined routing placement forwires228 relative toinstrument100A, as well asposition wires228 below anouter surface406 ofsleeve190. Flexible printedcircuit sheet232 can conform to an outer surface ofmalleable suction instrument100A and can provide for efficient and cost effective termination ofcoil assembly wires228 andlead wires236, as shown for example inFIG.17. For example,flexible circuit sheet232 can be flexed to correspond to a radius of the outer surface of the instrument so as to lay substantially flush or coplanar to the outer surface.
• With particular reference toFIG.18, flexible printedcircuit sheet232 is shown associated with an electromagneticpatient tracker device410. In the exemplary configuration illustrated,tracker device410 can include the threecoil assemblies214 positioned equidistant circumferentially around a longitudinal axis414 oftracker device410 and can be configured to communicate with and be tracked byEM tracking system60 ofnavigation system10. Thecoils assemblies214 can also be positioned, in the exemplary configuration illustrated, at an angle, such as between forty-five degrees and fifty-five degrees relative to axis414 in a similar manner ascoil assemblies214 are positioned relative toinstrument100 shown inFIG.5. It will be appreciated, however, that variousother coil assembly214 configurations and/or orientations can be utilized withpatient tracker410.
• The flexible printedcircuit sheet232 can be positioned inside of or within abody418 oftracker410 as shown inFIG.18, or could alternatively be positioned on anouter surface422 oftracker410. In one exemplary configuration, flexible printedcircuit sheet232 can be bent or flexed to conform to the shape or contour of the surface it will be adhered to, as shown inFIG.18. Sensor and lead wires (not shown for clarity) can be soldered to the respective circuit pads in the manner discussed above.
• Turning now toFIGS.19 and20A-20C, another exemplary configuration of a flexible printed circuit sheet is shown at232B. Flexible printedcircuit sheet232B can be similar to flexible printedcircuit sheet232A such that like reference numerals refer to like components or features and only differences will be discussed in detail. Similar to flexible printedcircuit sheet232A, the flexible printedcircuit sheet232B can includebase layer244 havingupper surface354,conductive traces350, solder orcoupling pads358 andtop insulative layer362.
• The flexible printedcircuit sheet232B can include one or more paired circuit traces where the pairs of circuit traces are closely spaced together, as shown for example inFIG.19. By positioning the circuit traces in such a manner along thelongitudinal axis374, any electromagnetic interference and/or pickup from an associated electromagnetic navigation system can be minimized. In this exemplary configuration, theconductive traces350 can be parallel or substantially parallel to each other and spaced apart by less than 0.3 mm, including 0.23 mm, in each pair of circuit traces. However, it should be appreciated that other spacing may be utilized depending on design and other variables.
• With particular reference toFIGS.20A-20C, three exemplary configurations (shown in side views) of the flexible printedcircuit sheet232B are shown. In these exemplary configurations, various different thicknesses of the flexible printedcircuit sheet232B are shown with and without adhesive, as will be discussed in greater detail below.
• Referring toFIG.20A, flexible printedcircuit sheet232B is shown in aconfiguration utilizing adhesive364. In this configuration, thebase layer244 can include a thickness of approximately 0.01 mm, the conductive traces andpads350,358 can include a thickness of approximately 0.04 mm and theinsulative layer362 can include a thickness of approximately 0.02 mm. In the assembled configuration, the flexible printedcircuit sheet232B shown inFIG.20A can include anoverall thickness388 of approximately 0.07 mm withoutadhesive364 and anoverall thickness388A of 0.11 mm withadhesive364.
• With reference toFIG.20B, the flexible printedcircuit sheet232B is shown having a smalleroverall thickness388 of approximately 0.05 mm withoutadhesive364 and anoverall thickness388A of 0.07 mm withadhesive364. In this configuration, thebase layer244 can similarly have a thickness of approximately 0.01 mm, the conductive traces andpads350,358 can include a thickness of approximately 0.02-0.03 mm and the insulative layer can include a thickness of approximately 0.01 mm.
• Referring now toFIG.20C, the flexible printedcircuit sheet232B is shown in another exemplary configuration having anoverall thickness388 of approximately 0.04 mm. In this configuration, adhesive364 may not be utilized. In such a configuration where adhesive364 is not utilized, a heat shrink layer over the flexible printedcircuit sheet232B can optionally be utilized to couple flexible printedcircuit sheet232B to an instrument, such as thesuction instrument100 discussed above. In this configuration of flexible printedcircuit sheet232B, thebase layer244 can also include a thickness of approximately 0.01 mm, the conductive traces andpads350,358 can include a thickness of approximately 0.01-0.02 mm, and theinsulative layer364 can include a thickness of approximately 0.01 mm.
• Referring now toFIG.21, an alternatesurgical instrument100 will be described in greater detail. Similar reference numerals will be used to describe similar structures shown inFIGS.2-4. In one exemplary configuration, thesurgical instrument100 can be a malleable tool used for suction, including fluid and tissue removal in ENT procedures. Associated with thesurgical instrument100 is aflexible circuit430 to transport electrical signals between thenavigation probe interface80 and a plurality of navigation coils214. Theflexible circuit430 provides termination pads (not shown) for fine coil wires as well as cable wires andconductive traces350 to bring electric connectivity to portions of thesurgical instrument100. As described further below, theconductive traces350 are configured to minimize the pickup of stray electromagnetic noise.
• Theflexible circuit430 described in detail below can be usable in other tracked medical devices or any other devices where tracking or navigating a distal tip of a device is desired. Thus, while the following description continues with reference to a navigatedsurgical instrument100, the discussion is also applicable to the surgical instruments discussed above and any other appropriate instruments that require tracking or navigation of instruments that require substantially smooth exterior surfaces so as to not adversely interact with patient tissue. This is in contrast to existing instruments that have discrete wires wrapped around the outside of the instrument causing a ribbed effect. For example, the flexible circuit can be used in a micro coil based core tracker assembly, slanted coil based cranial stylets, biopsy needles, or other navigated instruments requiring challenging volumetric packaging constraints.
• Surgical instrument100 can include atube assembly110, ahandle assembly114, and atracking sensor arrangement118.Surgical instrument100 or portions thereof can be configured for a single use such that it would be disposed of after such use. Thetube assembly110 can include a malleable elongatedtubular body126 and aninsert portion130. The malleabletubular body126 can be formed from a malleable metallic material such that thetubular body126 body portion can be bent between the proximal and distal ends from a first configuration to a second bent configuration and maintain the bent configuration.
• Thetubular body126 can include anouter diameter134 and aninner diameter138 and can have a first orproximal end142 coupled to thehandle assembly114 and a second opposite ordistal end148 configured to receiveinsert portion130. As best seen inFIG.4, thesecond end148 can include an internalannular recess152 having aninner diameter156 greater than theinner diameter138 of the remaining portion ofbody126. Thebody126 can also be provided in various lengths and diameters including, by way of example, lengths from 50 mm-500 mm and including 7, 9 and 12 French diameters. Theinsert portion130 can be configured to provide non-malleable support for at least the trackingsensor84.
• Insert portion130 can include asleeve190 received on an exterior thereof.Sleeve190 can include aninner diameter194 substantially equal to the outer diameter ofinsert portion130, and anouter diameter198 substantially equal to theouter diameter134 ofbody126. The insertion of thesleeve190 into thefirst end148 of the body can facilitate the electronic coupling of tracking coils with the navigation system. Alternatively, electronic coupling can be accomplished using soldering techniques. It should be appreciated thatsleeve190 can also be configured with different diameters relative tobody126.
• FIG.22 represents a top view ofconductive traces436,438 associated with theflexible circuit430 ofFIG.21. The conductive traces436,438 are twisted to form loops configured to have opposite handedness from its nearest neighbors. The alternative handedness effectively cancels electromagnetic noise. In this regard, the twisted pairs minimize electromagnetic pickup that would degrade navigation performance. The twisted pair configuration is formed using through-substrate orbase layer434 connections, as is illustrated exemplarily inFIG.24D on theflexible base layer434, and provides the needed form factor. In this regard, theflexible circuit430 protrudes from the nominal surface radius of thebody portion126 by less than about 0.05 mm, thus minimizing interaction of the device with patient tissue. In other words, the thickness of the flex circuit is 0.08 mm which is less than the thickness of the twisted wires 0.4 to 0.5 mm. The conductive traces436,438 have first andsecond coupling pads350 and358 disposed at a firstproximal end142 and a second set ofcoupling pads350 and358 disposed at the seconddistal end148, wherein the length of theflexible circuit430 extending from the firstproximal end142 to the seconddistal end148 is of theelongated body126. Furthermore, the profile of the construction utilizing theflexible circuit430 is substantially smoother and more uniform than the ribbed profile of the twisted wire configuration.
• With particular reference toFIGS.23A and23B, theflexible circuit430 having one or more, including three pairs ofconductive traces436,438 as illustrated inFIG.22 is shown. Theflexible circuit430 is generally disposed around thebody portion126 and extends from thetracking device84 from the seconddistal end148 to the firstproximal end142 and handleassembly114. The flexible circuit is configured to conform to the bent configuration of thebody portion126 such that it does not strain or break during bending of thebody portion126. Theflexible circuit430 can be longitudinally or helically disposed around a portion of thebody portion126 from thetracking device84 to thehandle assembly114. If longitudinally disposed, the flexible circuit is curved transverse to the longitudinal axis of theflexible circuit430 to conform to the curvature of the instrument shaft, as shown inFIG.23A. Theflexible circuit430 can have a sinusoidal periphery or have a periphery formed of a plurality of curved line segments. If helically disposed, theflexible circuit430 is wrapped helically around the longitudinal axis as is shown inFIG.21. To allow thebody portion126 to curve when theflexible circuit430 is wound around thebody portion126, the flexible circuit can definegaps433 which allow and accommodate for compression and tension of an external surface of thebody portion126. When the outer portion of thebody portion126 is in tension, thegaps433 can expand, while the inner portion during the bending of thebody portion126.
• FIG.23A represents themalleable tube110 shown inFIG.21. As shown, theflexible circuit430 extends from the firstproximal end142 of thebody portion126 to the seconddistal end148 of thebody portion126. A serpentine shapedflexible circuit430 is laid longitudinally wrapped around thebody portion126. As described below, the conductors in theflexible circuit430 can be generally parallel (seeFIG.24F) or form twisted pairs (SeeFIG.24A) to allow the navigation system to properly account for electromagnetic noise. Each twist in the twisted pair produces a small loop to reduce electromagnetic coupling noise.
• FIG.23B represents theflexible circuit430 in a planar manner before it has been conformed as is shown inFIG.23A. The serpentine shaped flexedcircuit430, when wrapped around thebody portion126, defines thegaps433 along edges of the flexible circuit. It is envisioned the maximum radius of curvature of thebody portion126 may be regulated by the size and positions of the definedgaps433.
• FIGS.24A-240 represent perspective views of exemplary configurations of theflexible circuit430 according to the present teachings. Generally, theflexible circuit430 has the first and secondconductive traces436,438 which are parallel or are twisted to reduce the influence of electromagnetic noise on the tracking system. Theflexible circuit430 can have abase layer434 formed of a thin insulative material such as polyimide, polyethylene, terephthalate, latex, nitrile rubber, polysiloxanes, silicone, polyurethane, polyether block amide (trade name PEBAX), afirst circuit trace436 having a firstupper portion460 of the trace formed on a firstupper side441 of thebase layer434, and asecond circuit trace438 having a secondlower portion462 formed on an secondlower side442 of thebase layer434. Theflexible circuit430 can take any number of shapes which allow theflexible circuit430 and medical device to bend.
• Thebase layer434 and insulative layers include material properties and a thickness configured to facilitate theflexible circuit430 being flexible such that theflexible circuit430 is adapted to conform to an exterior surface of theelongated body126, as well as allow theelongated body126 to bend along the longitudinal axis of thebody portion126. Theflexible circuit430 can have various components disposed between the proximal anddistal ends143,149. In this regard, various electrical components such as amplifier or tracking coils can be attached. For example,coil assemblies214 can be coupled to theflexible circuit430 at predetermined locations between the proximal anddistal end143,149. In other words, a single coil assembly can be located at the seconddistal end149, multiple coils can be located along the length of theflexible circuit430.
• As shown inFIG.24A, the conductive traces436,438 can form a twisted pair configuration. Thefirst trace436 runs along the firstupper side441 and crosses over asecond trace438 positioned on an oppositesecond side442 at an acute angle A. Thefirst trace436 then passes through the insulator orbase layer434 and runs along the secondlower side442. A second trace runs along the secondlower side442 and crosses over afirst trace436 positioned on the firstupper side441 at the acute angle A. The first and secondconductive traces436,438 cross from over to under atelectrical vias439. Thevias439 extend transversely through thebase layer434 to connect the conductive trace from the firstupper side441 to the secondlower side442.
• FIGS.24B and24C represent aflexible circuit430 having three twisted pair configurations as shown inFIG.24A as they would be wrapped around anelongated body126. As shown,coupling pads358 are provided for coupling to the leads of three coils at the seconddistal end149 or to the coupling cable wires at the firstproximal end143. Thevias439 are disposed between the overlapping conductive traces436,438 were the traces are located on opposite sides of thebase layer434. Generally, the conductive traces436,438 are positioned adjacent and parallel to each other to minimize conductor loop size.
• As shown inFIG.24D, the loop area446 can be reduced by placing thefirst trace436 directly over thesecond trace438 on thebase layer434 for a majority of the length of the trace except where the conductive traces separate to form vias439 in passingareas448. In other words, for short distances, the conductive traces separate enough to allow the traces to pass through thebase layer434 to the other side. At this point, the traces return to a position where they are parallel to each other. The loop area can further be reduced by reducing the thickness of theinsulative base layer434. It is envisioned thebase layer434 can have a thickness of about 0.025 mm. Thebase layer434 can be formed of polyimide, polyethylene, terephthalate, as well as a thin elasticinsulative base layer434. The base layers434 can be latex, nitrile rubber, polysiloxanes, silicone, polyurethane, polyether block amide or PEBAX.
• As shown inFIG.24E, by using multiple base or insulative layers, and placing oppositely handed twisted pairs intertwisted with an adjacent pair of conductors, further noise cancellation can be accomplished. The oppositely handed twisted pairs connect in parallel, adding redundancy to this canceled double twisted pair configuration. As previously discussed,conductive traces436,438 are periodically passed through from a firstupper side441 of thebase layer434 to a secondlower side442 of thebase layer434 to form the twisted configuration. As can be see, up to fourconductive traces436,438 can be separated by insulative layers and run in parallel with the second pair being a twisted pair with opposite handedness to the first pair of conductive traces. These conductive traces are shuttled through various basedlayers434 to form the twisted pair constructions.
• As shown inFIGS.24F and24G, the pair conductive traces436,438 need not be in a twisted pair configuration.FIG.24F depicts a noise minimizing parallel pair set. The configuration uses the thinness of the base layer to minimize noise.FIG.24G depicts a double oppositely oriented parallel pair with the second pair being a twisted pair with opposite handedness to the first pair of conductive traces. Theproximal end143 of theflexible circuit430 has a pair ofcoupling pads358. Thecoupling pads358 are coupled to a pair of parallelconductive traces436,438 which are directly over one another, each disposed on opposingsides441,442 of thebase layer434. At thedistal end149 of thebase layer434, another pair ofcoupling pads358 are provided to couple the flexible circuit to the tracking coils or trackingdevice84. In situations where there are numerous conductive traces on thesame base layer434, coupling pads can be found on first and second (top or bottom) sides of thebase layer434. This allows for the convenient coupling of tracking devices to thebase layer434 using soldering or connectors.
• As shown inFIGS.24H-24N, the flexible circuits can have a sinusoidal form. Eachconductive trace436,438 can be defined on a single side of thebase layer434 and can have radius of curvature R which is between the outer and inner radiuses of curvature of thebase layer434. Alternatively, as shown inFIGS.24I and24J, the pairs of conductive traces can be formed in twisted pairs by alternating position on opposite sides of the flexible circuit as described above. The pair crossovers or vias349 occur at locations along the curve. Generally, the vias349 are positioned transverse to the longitudinal axis of thebody portion126 orbase layer434. As shown inFIG.24J, the vias occur at sinusoidal midpoints wherein atFIG.24I the vias occur at sinusoidal minimums or maximums. The vias349 are between peaks and valleys in the sinusoidal substrate in order to minimize the mechanical stresses on the electrical vias349. Generally, the through paths or vias349 will be formed perpendicular to the longitudinal axis of the tool.
• As shown inFIGS.24K and24L, three pair of conductive traces can be formed on a single serpentine or sinusoidal shapedbase layer434. In other words, the conductor traces436,438 can be three pairs of conductive traces in a single serpentineflexible circuit430. As can be seen, the position of thevias439 can be staggered along the length of the flexible circuit so each new curvature represents a new location for thevia439. Alternatively, thevias439 can be staggered adjacent to the centerline of the flexible circuit.
• As shown inFIGS.24M-24N, a pair of serpentineflexible circuits430 can be braided together to form a flat twisted pair by combining two individual sinusoidal patterned base layers434, each with three sinusoidally patterned traces explicitly braided into three flat pairs. The base layers434 can be joined at theproximal end142 to facilitate the coupling of thetracking device84. The use of severalflexible circuits430 in this configuration can provide a proper level of rigidity of thebody portion126.
• FIG.240 represents an alternateflexible circuit430 having a braided pair configuration. The leads436,438 are disposed through the base layer and wrapped aroundapertures440 defined in the base layer344. As shown, the base layers434 form the braided pair configuration and can alternate sides of theflexible circuit430 as described above.
• Referring toFIG.25, a cross-sectional view of theflexible circuit430 is shown in a configuration utilizing a pressuresensitive adhesive364. In this configuration, thebase layer434 can include a thickness of approximately 0.01 mm, the conductive traces436,438 andpads350,358 can include a thickness of approximately 0.04 mm, and theinsulative layer362 can include a thickness of approximately 0.02 mm. In the assembled configuration, the flexible printed circuit sheet can include anoverall thickness388 of approximately 0.07 mm withoutadhesive364 and anoverall thickness388 of 0.11 mm withadhesive364.
• With reference toFIG.26, theflexible circuit430 is shown having a smalleroverall thickness388 of approximately 0.05 mm withoutadhesive364, and anoverall thickness388 of 0.07 mm withadhesive364. In this configuration, thebase layer244 can similarly have a thickness of approximately 0.01 mm, the conductive traces436,438 andpads350,358 can include a thickness of approximately 0.02-0.03 mm, and the insulative layer can include a thickness of approximately 0.01 mm.
• It will be appreciated that while various configurations of flexible printed circuit sheets have been discussed herein, other configurations can be utilized taking advantage of the thin, compact and conformable features of such flexible printed circuit sheets. In this exemplary configuration, such a flexible printed circuit sheet could include a length configured to be helically wound from thedistal end148 to thehandle assembly114.
• While one or more specific examples have been described and illustrated, it will be understood by those skilled in the art that various changes may be made and equivalence may be substituted for elements thereof without departing from the scope of the present teachings as defined in the claims. Furthermore, the mixing and matching of features, elements and/or functions between various examples may be expressly contemplated herein so that one skilled in the art would appreciate from the present teachings that features, elements and/or functions of one example may be incorporated into another example as appropriate, unless described otherwise above. Moreover, many modifications may be made to adapt a particular situation or material to the present teachings without departing from the essential scope thereof.

Claims (20)

What is claimed is:

1. A surgical instrument, comprising:

an elongated body extending from a proximal end to a distal end,

the elongated body is tubular-shaped and has a first internal passage extending between the proximal end and the distal end;

a handle coupled to the proximal end of the elongated body, the handle having a second internal passage in fluid communication with the first internal passage; and

a first tracking coil positioned adjacent to the distal end of the elongated body, the first tracking coil extending between a first end and a second end and having an overall non-linear shape to conform to a surface of the elongated body, wherein a diameter of the first tracking coil between the first and second ends is different from a diameter at the first and second ends to maximize an amount of coil windings while minimizing a dimension of the elongated body.

2. The surgical instrument ofclaim 1, wherein the dimension is an outer diameter of the elongated body or an inner diameter of the elongated body.

3. The surgical instrument ofclaim 1, wherein:

the first tracking coil is disposed on an exterior surface of the elongated body;

the first tracking coil has a first side and a second side, which extend between the first and second ends of the first tracking coil;

the first side opposes the second side;

the first side has a concave shape that matches a convex shape of the exterior surface of the elongated body;

the second side has a planar shape; and

the first tracking coil includes more windings at the first and second ends of the first tracking coil than at a center of the first tracking coil.

4. The surgical instrument ofclaim 1, wherein:

the first tracking coil is disposed on an interior surface of the elongated body;

the first tracking coil has a first side and a second side, which extend between the first and second ends of the first coil;

the first side opposes the second side;

the first side has a convex shape that matches a concave shape of the interior surface of the elongated body;

the second side has a planar shape; and

the first tracking coil has more windings at a center of the first tracking coil than at the first and second ends of the first tracking coil.

5. The surgical instrument ofclaim 1, wherein the elongated body includes a tubular insert at the distal end and a sleeve configured to be received over the insert, wherein the first tracking coil is coupled to the sleeve adjacent to the distal end thereof.

6. The surgical instrument ofclaim 1, further comprising a pair of lead wires helically wound around the elongated body from the first tracking coil to the handle.

7. The surgical instrument ofclaim 6, further comprising a printed circuit board positioned adjacent the first tracking coil, wherein the printed circuit board is configured to couple the pair of lead wires to the first tracking coil.

8. The surgical instrument ofclaim 1, further comprising a second tracking coil positioned adjacent the distal end of the elongated body, the second tracking coil extending between a first end and a second end and having an overall non-linear shape to conform to a surface of the elongated body, wherein a diameter of the second tracking coil between the first and second ends is different from a diameter at the first and second ends of the second tracking coil to maximize an amount of coil windings while minimizing the dimension of the elongated body.

9. The surgical instrument ofclaim 1, wherein the first tracking coil is wrapped around a core and mounted adjacent to the distal end of the elongated body.

10. A surgical instrument, comprising:

a body having a proximal end and a distal end, wherein the body is tubular-shaped and has an internal passage extending between the proximal end and the distal end;

an insert received in the distal end of the body;

a sleeve received over the insert at the distal end of the body; and

a tracking coil positioned on an exterior surface of the sleeve, the tracking coil extending between a first end and a second end and having a first side and a second side, the first side opposes the second side and the first side has a concave shape that matches a convex shape of the exterior surface of the sleeve, the second side has a planar shape, wherein the tracking coil has more windings at the first and second ends of the tracking coil than at the center of the tracking coil.

11. The surgical instrument ofclaim 10, wherein the body is formed from a malleable material such that the body can be bent between the proximal and distal ends from a first configuration to a second bent configuration.

12. The surgical instrument ofclaim 11, wherein the insert prevents bending or flexing in a region where the insert is received in the distal end of the body and wherein the insert provides rigid support for the sleeve to prevent bending of the sleeve.

13. The surgical instrument ofclaim 10, wherein the distal end of the body includes an annular recess defining an internal shoulder and the insert is partially received within the distal end in the annular recess engaging the internal shoulder.

14. The surgical instrument ofclaim 13, wherein the sleeve is adjacent to and not in contact with the distal end of the body when positioned on the insert.

15. The surgical instrument ofclaim 12, further comprising a printed circuit board positioned at the distal end where the insert is received in the body to prevent bending or flexing of the printed circuit board.

16. A surgical instrument, comprising:

a body having a proximal end and a distal end, wherein the body is tubular-shaped and has a first internal passage extending between the proximal end and the distal end;

an insert received in the distal end of the body;

a sleeve received over the insert at the distal end of the body; and

a tracking coil positioned on an interior surface of the sleeve, the tracking coil extending between a first end and a second end and having a first side and a second side, the first side opposing the second side and the first side has a convex shape that matches a concave shape of the interior surface of the sleeve, the second side has a planar shape, wherein the tracking coil has more windings at a center of the tracking coil than at the first and second ends of the tracking coil.

17. The surgical instrument ofclaim 16, wherein the insert prevents bending or flexing in a region where the insert is received in the distal end of the body and wherein the insert provides rigid support for the sleeve to prevent bending of the sleeve, wherein the distal end of the body includes an annular recess defining an internal shoulder and the insert is partially received within the distal end in the annular recess engaging the internal shoulder.

18. The surgical instrument ofclaim 16, further comprising a handle coupled to the proximal end of the body, wherein the handle includes a second internal passage extending through the handle and in fluid communication with the first internal passage.

19. The surgical instrument ofclaim 18, further comprising a pair of lead wires wound around the body from the tracking coil to the handle.

20. The surgical instrument ofclaim 16, wherein the tracking coil is wrapped around a core.

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