Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/08—Auxiliary means for directing the radiation beam to a particular spot, e.g. using light beams
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
  • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
  • A61B90/13—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints guided by light, e.g. laser pointers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations

Definitions

• This invention pertains to a system (method and
• the system is especially suitable for use in surgery for locating specific sub-surface regions of the anatomy and providing a light beam for sighting an incision so that the specific region can be reached and exposed for surgical
• the invention will also be found useful for precisely locating other internal structures, such as a region of an encased electronic circuit board or integrated circuit
• Another use for the invention is to allow for the accurate location and positioning on the surface anatomy
• radioactive sites within the patient produced by radionuclides examples include tumor marking, by means of injected radioactive
• the above mentioned cylindrical central ray locating device and the substitution of a Cylinder containing a laser with the attendant possibility of a change in the mounting alignment and therefore an error in the representation of the central ray by the laser. From a surgical perspective, the above mentioned laser can not be used while imaging internal structures because its placement in the path of the X-ray beam obstructs the image forming rays.
• British Patent No. GB 2175778A published December 3, 1986 discloses a device for aligning a patient at the proper distance from a fixed X-ray source so as to allow for a properly focused image to be formed on a photographic plate.
• a beam splitter and a mirror are used to create converging primary and a secondary laser beams which intersect at a predetermined distance from the X-ray source.
• the device aligns the patient at the proper film to focus distance. There are deviations in the central X-ray beam due to normal anode wear on the X-ray source and concomitant deviation of the X-ray path from the source.
• a deep depth imaged by an external radiation source provides a true access of approach to, a subsurface or deep structure imaged by an external radiation source.
• structure is, for example, a portion of the internal anatomy of a patient which is identifiable from surrounding structures by its differential radiotranslucency and which is medically of
• interest e.g. a tumor, or a locking screw hole in femoral rod or metal plate.
• An ancillary object of the invention is to provide an improved laser surgery system which reduces the inherent error in surgery using hand held lasers, by deep structure targeting.
• the invention enables the use of operative high power lasers to increase the accuracy, and provide direct access of approach to subsurface structures which need to be cauterized, vaporized, excised or coagulated, without the attendant surgical trauma, which is the result of current use of hand held surgical lasers.
• a still further object of the invention is to provide an improved system for surgical operations which allows for automation of such operations, which involve the use of a
• surgical laser scalpel surgical through computer controlled positioning of the surgical laser and is especially adapted for use in microsurgery on deep structures as in the inner ear or on photosensitive tumors.
• a system in accordance with the invention provides accurate access of approach to a desired deep structure visualized with a medical or other imaging system.
• a fixture is mounted in the path of the first radiation source, for example the X-ray source of a fluoroscope.
• the fixture removably mounts a calibration tube.
• a second radiation source for example, a laser providing a light beam, is also mounted in the fixture.
• the light beam is directed by means of a mirror which is transparent to the first radiation, for example, an X-ray transparent mirror, along the axis of the calibrating tube. This beam is in general, any reflected portion of the second radiation source, for example the X-ray source of a fluoroscope.
• the fixture removably mounts a calibration tube.
• a second radiation source for example, a laser providing a light beam
• the light beam is directed by means of a mirror which is transparent to the first radiation, for example, an X-ray transparent mirror, along the axis of the calibrating tube. This beam
• Radio opaque cross hairs at opposite ends of the calibrating tube are visualized on the fluoroscope ⁇ s TV monitor, which has a detector sensitive to the radiation from the first source (X-rays) and provides an image which is illuminated by that radiation.
• the fixture has means for adjusting the X, Y coordinates of the light beam with respect to a central ray of the first radiation (X-rays) so that the ray and beam are aligned along a line through the intersections of the cross hairs of the calibration tube. Then, the cross hairs are, when viewed on the TV monitor, superimposed on one another, which indicates that the line running from the intersections of the cross hairs is
• the ray is preferably the central ray, but may be another ray and is hereafter called an identifiable ray. Due to the precise alignment of the reflected portion of the secondary radiation with the cross hairs of the calibration tube the reflected portion of the secondary radiation is collinear with the calibration tube and with the identifiable ray from the X-ray source. At the point indicated by the
• a radio-opaque target symbol is affixed.
• the target symbol is now collinear with the
• the fixture does not obstruct the first radiation and the secondary radiation can, therefore, operate concurrently with the first radiation for locating the deep structure and providing the visible line of sight thereto.
• any object placed in the path of the identifiable ray will be imaged by the first and second radiation source both internally and externally in a manner which allows superposition of the images .
• the target symbol is mounted in the fixture, behind the mirror. With the target symbol in the fixture, the system is easier and more convenient to use without any loss in accuracy.
• FIG. 1 is a diagrammatic, exploded, perspective view showing generally the light and X ⁇ -ray radiation sources, the calibration tube and the target of an exemplary system in
• FIG. 2 is an exploded view of an X-Y-Z positioner and calibration tube of the exemplary system
• FIG. 3 is a perspective view of the X-Y-Z positioner without calibration tube
• FIG. 4 is a perspective view of the X-Y-Z positioner with calibration tube in place, the view being rotated 90° counter-clockwise from the view of FIG. 3;
• FIG. 5 is a sectional view along the line A-A in
• FIG. 4
• FIG. 6 is a sectional view taken along the line B-B in FIG. 4;
• FIG. 7 is a perspective view of the system including an X-ray fluoroscope
• FIG. 8 is a perspective view of the system in operation in locating a deep structure
• FIG. 9 is a perspective view similar to FIG. 4 showing a surgical laser and means for the automatic positioning thereof;
• FIG. 10 is a diagrammatic, exploded, perspective view showing the light and x-ray radiation sources, the calibration tube and the target of an exemplary system in accordance with an alternative embodiment of the invention.
• FIG. 11 is a perspective view of the X-Y-Z positioner with calibration tube in place for the alternative embodiment shown in Fig. 10;
• FIG. 12 is a sectional view taken along the line A-A in Fig. 11;
• FIG. 13 is a sectional view taken along the line B-B in Fig. 11;
• FIG. 14 is an exploded view of the X-Y-Z positions and calibration tube for the alternative embodiment shown in FIG. 10;
• FIG. 15 is a perspective view of the system including an X-ray fluoroscope in accordance with the alternative
• FIG. 16 is a perspective view of the system shown in FIG. 15 in operation in locating a deep structure.
• the illustrative dual radiation targeting apparatus in FIG. 4 comprises a framework which consists of a base 30 and a clamping mechanism, 18, 19, 20, and 25 which are mounted, as shown in FIG. 7 on the X-ray source 46 of a fluoroscope 51 consisting of X-ray source 46, held in fixed relation to an image intensifier 49, within housing 50, by generally C shaped yoke or arm 48. Mounting is performed by turning clamping screws 18, 19 having reverse threaded portions 44 thereon, shown in Fig. 5, such that clamp arms 20, 25 are drawn together to affix the above mentioned assembly to the X-ray source 46. Adjustment screws 21, 22, 23, 24 are turned to make the base 30 orthogonal to the axis between the X-ray source 46 and the image intensifier 49, which provides a detector of the image formed by X-ray illumination from the source 46.
• the fluoroscope 51 is energized and an image is viewed on screen 55 of monitor 53 on stand 54.
• the image consists of cross hairs 56, 57 which represent the
• radio-opaque opaque to X-rays, radiation from a radioactive source or the like
• cross hairs 12, 13 shown in Fig. 1 which lie generally in the path of radiation sources 1 or 46 in Fig. 7.
• These cross hairs 12, 13 are contained in radiolucent disks 11, 13 which are in turn mounted in the bore of calibration tube 15 which is permanently fixed to calibration tube base 10, which is removably affixed by means of locking screws 8, 9, 43, 45 as shown in Fig. 1 and Fig. 4, to the radiolucent X stage 38.
• the laser source is a laser diode which emits a visible beam 42 shown in Fig. 7.
• radiolucent X stage 38 is slidably affixed within the Y stage 34 and is positioned therein by means of the cooperative
• X axis screw 41 and its receptacle 31 and return springs 32, 35 and their respective receptacles 33, 36 The slidable relationship of the Y stage 34 with respect to base 30 is facilitated by slot 63 shown in Fig. 3.
• Receptacles 31, 33, 36 are permanently affixed to Y stage 34.
• the Y stage 34 is in turn slidably affixed within base 30 and is positioned therein by means of the cooperative relationship of Y axis screw 26 and its receptacle 27 and return spring 28 and its receptacle 29 which receptacles 27, 29 are permanently affixed to base 30.
• a calibration procedure is then performed, the object of which is to adjust the position of the X , Y stages 38, 34 to move the calibration tube 15 and cross hairs 12, 13 so as to align the cross hair images 56, 57 on screen 55 in Fig. 7 such that they are superimposed.
• This will indicate that the center axis of the calibration tube cross hairs is collinear with an axis of radiation and hence an identifiable ray.
• laser 6 is mounted in radiolucent X stage 38 so as not to occlude the radiation from the X-ray sources 1 or 46, in Fig. 7.
• Laser 6 is mounted in radiolucent X stage 38 so as to direct its beam at radiolucent mirror 7 mounted in slot 37 in radiolucent X stage 38.
• the cooperative relation of laser 6 and mirror 7 is such that the reflected laser beam, the beam reflected off the mirror 7, follows a path which is collinear with the axis that passes through the centers of calibration tube cross hairs 12, 13.
• Power is supplied to the laser by means of a rechargeable power pack 3 which power pack has a control switch 2, a recharging receptacle 39, and a laser power output receptacle 40.
• Laser power plug 4 transmits power to the laser via wire bundle 5.
• the next procedural step is to adhesively place translucent target disk 16 on image intensifier screen 49 so that the target symbol, or in this case the radio-opaque cross hairs 17, is positioned so that the target symbol center intersects the laser beam 42.
• the calibration cross hairs 12, 13, and the target symbol cross hair 17 will when viewed on TV screen 55 appear as a single cross hair. This indicates that the laser beam and the target symbol are collinear with the identifiable ray and that the calibration tube can be removed if desired to increase the operating distance between the dual radiation targeting apparatus mounted on the X-ray source 46 and the image intensifier 49.
• a deep structure for example: a hole in a
• radio-opaque intramedullary rod reinforcing a fractured femur, and requiring a screw to be placed through the surrounding femur and into the hole in said intramedullary rod in order to
• Hemisphere 60 on surgical platform 47, represents the surrounding bone and tissues all of which have varying degrees of radiolucency .
• the image of the radio-opaque intramedullary rod and the locking screw hole represented as the star ⁇ ss center 62, and the target symbol 61 are viewed on the TV screen 55. Fluoroscope 51 position adjustments are made so as to place the center of the target symbol 61 over the center of the hole in the
• the fluoroscope may be de-energized if desired, since the laser beam provides a visible line of sight and indicates the axis of approach to and the location of the deep structure of interest, in this case the intramedullary rod hole.
• the surgeon may now surgically approach the femur and drill through it with full confidence that, as long as the tip of the drill follows the line of sight provided by the laser beam 42, the drill will directly access the hole.
• the calibration controls are automatic and a surgical laser, for example, a CO 2 laser is used in place of the laser diode, in order to cut, cauterize, coagulate, or vaporize, an imaged structure.
• a surgical laser for example, a CO 2 laser is used in place of the laser diode, in order to cut, cauterize, coagulate, or vaporize, an imaged structure.
• servo-motors 64, 69 position the X and Y stages during calibration and programmed operation.
• X servo-motor 64 is attached to shaft 58, which corresponds in function to shaft 41 in Fig. 2,3,4,5.
• X servo-motor 64 is
• frame 67 is slidably mounted in slide rail 80, which slide rail is permanently affixed to base 30, so as to also allow for displacement of frame 67 and motor 64 corresponding to displacement of Y stage 34.
• Y servo-motor 69 is attached to shaft 68, which corresponds in function to shaft 26 in FIGS. 2, 3, 4, 5.
• Y servo-motor 69 is slidably mounted in frame 72 by means of slides 70, 71 so as to allow for motor displacement corresponding to 7-stage 34 displacement during calibration and programmed operation.
• the calibration tube 15 and attached base 10 shown in Fig. 4 will be removed as shown in Fig. 3.
• a CO 2 laser is substituted for the laser diode 6 and a mirror suitable for reflecting the CO 2 laser beam is installed so as to direct the CO 2 laser beam along the same path as the reflected beam from the laser diode.
• an autofocus system with Z axis drive 73 is mounted in the same manner and in the same location as the calibration tube base.
• Autofocus system with Z axis drive may notably be an apparatus such as that sold under the trademark ACCUFOCUS by the Laser Mech Company, Southfield
• the autofocus system contains a Z-axis servomotor drive in housing 73, a focusing tip 79, a high
• the autofocus system is attached to X stage 38 by means of base plate 74 and associated mounting screws, of which two are shown, 75 and 76.
• the control wires for energizing the laser 6 as well as the three servomotors 64, 69, 73 are attached to a control box 81.
• the programming and control of the servo-motors 73, 69, 64 can be accomplished by many means ranging from manual to automatic. In the manual mode each axis of motion of the CO 2 laser would be under human control by means of switches and associated control circuitry which is well known in the prior art. In the automatic mode, the X, Y, Z coordinates of a deep structure imaged on screen 55 are
• FIG. 10-16 Targeting System is shown in Figs. 10-16.
• Corresponding elements in Figs. 10-16 have numeral designations which correspond to those in Figs. 1, 4, 5 and 6, respectively, and will not be described again.
• the target symbol 16 with cross-hairs 17 is located between radiolucent mirror 7 and the radiation source 1.
• the target symbol 16 is attached to the X-stage 38 and is adjacent the radiolucent mirror 7, as shown in Figs. 12 and 13, although other locations for the target symbol 16 could be used.
• the target symbol 16 in no longer attached to on the screen 49, as illustrated in Figs. 15 and 16.
• the target symbol 16 is integrally formed with the X-stage 38, although the target symbol 16 may be connected to the X-stage 38 with other types of
• the target symbol 16 is preferably connected to the system so that the center of the cross-hairs 17 rests on the same axis as the path of the laser beam. When the system is calibrated, the axis also passes through the centers of cross-hairs 12 and 13 in calibration tube 15.
• the image on the screen 55 comprises the cross-hairs 17, 12 and 13 which generally lie in the path of the radiation. If more than one set of cross-hairs appears on the screen 55, then the system needs to be calibrated.
• the X-axis screw 41 and Y-axis screw 26 are used to adjust the X-stage 38 and the Y-stage 33, respectively, to align the cross-hairs 17, 12 and 13 so they are superimposed. Superimposing the cross-hairs 17, 12 and 13 indicates that the axis is passing through the center of the cross-hairs 12 and 13 and the cross-hairs 17 and the axis is collinear with an identifiable ray.
• a beam locator (not shown) can be placed at the intersection point of the laser beam 42 with the image intensifier 49. If the center of the beam locator rests on the center of the superimposed cross-hairs, then the laser beam 42 is collinear with the identifiable ray.
• the calibration tube 15 may be removed to increase the operating distance from the dual radiation target apparatus mounted on the x-ray source 46 and the image intensifier 49.

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• Surgery (AREA)
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• Engineering & Computer Science (AREA)
• Heart & Thoracic Surgery (AREA)
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• 1992
  • 1992-01-29 US US07/827,672 patent/US5212720A/en not_active Expired - Lifetime
• 1993
  • 1993-04-12 US US08/535,023 patent/US5644616A/en not_active Expired - Fee Related
  • 1993-04-12 WO PCT/US1993/003440 patent/WO1994023651A1/en not_active Application Discontinuation
  • 1993-04-12 CA CA002160237A patent/CA2160237C/en not_active Expired - Fee Related
  • 1993-04-12 JP JP06523070A patent/JP3014454B2/ja not_active Expired - Fee Related
  • 1993-04-12 EP EP93910587A patent/EP0696177A4/en not_active Ceased

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