Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
  • G01R33/00—Arrangements or instruments for measuring magnetic variables
  • G01R33/20—Arrangements or instruments for measuring magnetic variables involving magnetic resonance
  • G01R33/44—Arrangements or instruments for measuring magnetic variables involving magnetic resonance using nuclear magnetic resonance [NMR]
  • G01R33/48—NMR imaging systems
  • G01R33/58—Calibration of imaging systems, e.g. using test probes, Phantoms; Calibration objects or fiducial markers such as active or passive RF coils surrounding an MR active material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3403—Needle locating or guiding means
• • 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
• • 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
  • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
  • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01R—MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
  • G01R33/00—Arrangements or instruments for measuring magnetic variables
  • G01R33/20—Arrangements or instruments for measuring magnetic variables involving magnetic resonance
  • G01R33/28—Details of apparatus provided for in groups G01R33/44 - G01R33/64
  • G01R33/285—Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00831—Material properties
  • A61B2017/00902—Material properties transparent or translucent
  • A61B2017/00911—Material properties transparent or translucent for fields applied by a magnetic resonance imaging system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3403—Needle locating or guiding means
  • A61B2017/3405—Needle locating or guiding means using mechanical guide means
  • A61B2017/3411—Needle locating or guiding means using mechanical guide means with a plurality of holes, e.g. holes in matrix arrangement
• • 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
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
• • 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

Definitions

• the present invention relates generally to breast imaging modalities and more particularly to localizers for use therewith.
• Breast cancer is the leading cause of death from cancer among women in the western world and the leading cause of death in general among persons 35 to 55 years of age.
• Imaging modalities for detection of breast lesions include X-ray mammography, sonography, thermography, computed tomography, angiography and magnetic resonance imaging (MRI) which are copiously described in the literature.
• MRI literature references include Kaiser, Werner A. , MR Mammocfraphy, Springer-Verlag, Berlin Heidelberg, 1993; Kaiser, Werner A. , "MRM promises earlier breast cancer diagnosis," Diagnostic Imaging. September 1992, pp.
• Stereotaxic localization literature references include Cosman, Eric, et al., "Combined Use of a New Target- Centered Arc System with the BRW Floor Stand and Phantom Base for a Wider Range of Approaches and Applications in Stereotaxy of the Head and Neck," Proceedings of the Meeting of the American Society for Stereotactic and Functional Neurosurgery. Montreal 1987. Applied Neurophysiology. 1987, 50:119-126; and, Giorgi, C. , et al. , “Three-dimensional Reconstruction of Neuroradiological Data within a Stereotactic Frame of Reference for Surgery of Visible Targets," Proceedings of the Meeting of the American Society for Stereotactic and Functional Neurosurgery. Applied Neurophysiology. 1987, 50:77-80; and, Derosier, C. , “MR and Stereotaxis, " Journal Neuroradiologie. 1991, 18, 333-339.
• Interstitial laser photocoagulation literature references include Castro, Dan, “Metastatic Head and Neck Malignancy Treated Using MRI Guided Interstitial Laser Phototherapy: An Initial Case Report," Laryngoscope 102. January 1992, 26-32; Steger, A.C., et al., "Interstitial laser hyperthermia: a new approach to local destruction of tumours," British Medical Journal. 1989, 299:362-5; and, Bown, S.G., “Minimally Invasive Therapy in Breast Cancer,” (abstract), JMRI, 1993, p. 27.
• Drill biopsy literature references include Ahlstrom, K. Hakan, et al., "CT-guided Bone Biopsy Performed by Means of a Coaxial Biopsy System with an Eccentric Drill," Radiology. 1993, 188:549-552; and, Meyerowitz, B.R., "Drill Biopsy Confirmation of Breast Cancer", Archives of Surgery, July 1976, Vol. Ill, 826-827.
• Literature references more specifically pertaining to MRI breast localization techniques include Hussman, Karl, et al., "MR Mammographic Localization Work in Progress," Radiology. 1993, 189 (p) : 915; Heywang-Kobrunner, S.H., "MRI of Breast Disease,” presented at the Twelfth Annual Scientific Meeting of the Society of Magnetic Imaging in Medicine, 1993, and Schnall, M.D., et al., "A System for MR Guided Stereotactic Breast Biopsies and Interventions," Proceedings of the Twelfth Annual Scientific Meeting of the Society of Magnetic Resonance in Medicine. 1993, 1:163.
• a pertinent reference pertaining to X-ray mammographic localization utilizing a bore array is Prejean, J.
• MRI can be realized because atoms with an odd number of protons or neutrons possess an intrinsic rotation or "spin" that, for clarity may be likened to the spinning of a top.
• the atomic nucleus also carries an electric charge, and the combination of spin and charge leads to the generation of a magnetic field around the particle.
• the nucleus represents a magnetic dipole whose axis is directed parallel to the axis of spin.
• the orientations of the proton spin axes are distributed statistically in space, so the magnetic dipoles cancel out in terms of their external effect.
• the magnetic moments become oriented either parallel or antiparallel to the external field.
• Each state has a different energy level, the parallel alignment being the more favorable state in terms of energy.
• the energy difference must either be added to or absorbed from the system from the outside. This can be accomplished by the application of an electromagnetic pulse at the magnetic resonance (MR) frequency or "Larmor frequency".
• MR magnetic resonance
• Larmor frequency In a magnetic field of 1 Tesla, for example, the Larmor frequency is 42 MHz.
• the applied radio frequency pulse tilts the spin axis of the protons out of alignment by an angle that depends on the amplitude and duration of the transmitted electromagnetic pulse.
• a 90° pulse is one that tilts the magnetization vector from the z axis to the xy plane, while a 180° pulse causes a complete inversion of the magnetization vector.
• relaxation commences as the nuclei return to their original states.
• This realignment process is characterized by a relaxation time Tl and corresponds to the motion of an electric charge in a magnetic field.
• the relaxation process causes the emission of an electromagnetic signal (the MR signal) from the nuclei that can be detected with special antennas (coils) .
• the pulse When the resonance frequency is applied to the sample as a 90° pulse, the pulse not only tilts the magnetic moment 90° but also tends to align the spin axes in the direction of the rf pulse.
• the angle of the spin axes is called the "phase”.
• the individual spins When the rf pulse ceases, the individual spins immediately begin to go out of phase.
• This "dephasing" process is called spin-spin relaxation and is characterize by a T2 relaxation time.
• the spin-lattice or Tl relaxation time describes the return of the magnetic moment to alignment with the external magnetic field. Both processes occur simultaneously in the same nucleus. Characteristic Tl values in biologic tissues range from 0.5 to 2 seconds and T2 values from 10 to 200 milliseconds.
• the MR signals generated by the tissue relaxation process vary greatly depending on the type of excitation pulses that are applied.
• the basic pulse sequences in clinical use include spin-echo, inversion recovery, gradient echo, and fat suppression. Specialized pulse sequences under these general types include FLASH, FISP, RODEO, and SNOMAN.
• Image plane selection is accomplished by superimposing a linear gradient field upon a static magnetic field. Because the gradient field increases linearly in one direction, e.g., along the z axis, there is only one site at which the resonance or Larmor frequency condition is met. The bandwidth of an applied rf pulse and the steepness of the gradient determine the thickness of the tissue slice from which MR signals emanate. When two additional gradient fields are applied in the x and y directions, frequency or phase information can be assigned to different points within the selected plane.
• a complete pulse sequence yields a raw-data image called a hologram.
• a 2- imensional Fourier transform is applied to the raw data to construct the final image.
• sectional images can be constructed on a coronal, axial or sagittal plane or in any oblique orientation desired (coronal, axial and sagittal planes are respectively those dividing the frame into front and back portions, those dividing the frame into right and left portions and those dividing the frame into upper and lower portions) .
• Components of an MR unit include a primary magnet, shim coils whose current supply is computer controlled to produce the desired field homogeneity, gradient coils to generate linear gradient fields, an rf coil for transmitting the rf pulses and receiving the MR signals (the signals may b-- received through the transmitting coil or a separate receiving coil) , a comr r for control of data acquisition, imaging parameters , ⁇ analysis and data storage media.
• the rf excitation signal and the MR signal emitted by relaxing nuclear spins are respectively transmitted and received with rf coil types that include surface coils, whole-volume coils (in solenoid, saddle and birdcage configurations) , partial-volume coils, intracavitary coils, and coil arrays.
• Breast coils are typically whole-volume solenoids used both for transmission and receiving. Such coils are especially suited for imaging frame regions that are perpendicular to the magnet aperture, e.g., breasts, fingers. They include square 4 pole resonators that can be inserted over the breast during imaging and Helmholtz pair resonators.
• Pairs of breast coils are often coupled to allow imaging of both breasts, e.g., see Model QBC-17 Phased Array Breast Coil, MRI Devices Corporation, 1900 Pewaukee Road, Waukesha, Wisconsin.
• the MR signal intensity varies exponentially with Tl and T2.
• a substance that alters the tissue relaxation times can be a potent image contrast enhancer.
• Gadolinium - diethylene triamine - pentaacetic acid (Gd - DTPA) is particularly suitable for producing contrast enhancement. Enhancement following injection seems to correlate with the vascularization of the lesion and the intense MR signal enhancement in carcinomas may be due to their increased vascular density.
• Dynamic imaging involves repetitive imaging of the same slices before and after injection of Gd - DPTA.
• MR signal increases can help differentiate carcinoma from benign breast lesions such as fibroadenoma, proliferative mastopathy, cysts, scars and mastopathies.
• Numerous investigations and tests have demonstrated the high sensitivity (proportion of people having a disease that are so identified by a test) and specificity (proportion of people free of a disease that are so identified by a test) of MR imaging and its ability to detect even small cancers, e.g., 3 - 5 millimeters.
• successful imaging of breast lesions must be accompanied by effective guidance of medical instruments to the lesion site to facilitate diagnosis and treatment.
• FIGS. IA, IB, and 1C are respectively front, top, and side views of a breast 20 and illustrate how the location of a breast lesion 21 is typically described in relation to a coordinate system centered on the breast nipple 22.
• the lesion 21 exhibits cranial spacing 24, medial spacing 26, and posterior spacing 28 from the nipple 22.
• FIGS. 1C it is apparent that if the breast 20 were allowed to assume a configuration different from that of FIGS. 1, these spacings would no longer accurately describe the lesion location.
• imaging and localization procedures are preferably completed without disturbing the breast position therebetween so that the imaging spacings used for localization are not corrupted.
• Non-invasive localization or guidance techniques include measurement of the spacing between the lesion and the nipple and between the lesion and the overlying skin surface and transposition of the measurements to the breast surface where the calculated site is marked as a guide for a surgeon. Because of the considerations described above, non-invasive techniques generally permit only approximate guidance.
• Invasive localization techniques often include apparatus for reducing breast movement.
• perforated compression plates are described in Svane, Schnall, Heywang-Kobrunner and Prejean in the above incorporated references.
• Localization using an MR visible coordinate systems is described by Hussman, Heywang- Kobrunner, and Schnall in the above mentioned references.
• Localization using bores which guide and stabilize the needle tip is described by Prejean and Hussman in the above mentioned references.
• Instructions (including a video tape) for constructing a needle guide-hole grid for localization of nonpalpable mammographic lesions have been prepared by Prejean, J. , et al.
• Invasive treatment techniques include the insertion of a carbon trail leading to the lesion vicinity with a carbon trail injector as described in Svane and Langlois in the above incorporated references.
• the carbon trail serves as a marker to guide a surgeon to the lesion.
• Hook-wires are inserted to the lesion vicinity for the same purpose. They are typically removed during surgery.
• Introducing a fiber optic to the lesion vicinity for treatment with laser energy is described in Bown and Steger in the above incorporated references (interstitial laser photocoagulation or ILP in Bown; interstitial laser hyperthermia in Steger) .
• the laser fiber is typically passed through a thin needle to the lesion site.
• laser therapy is performed with the breast in a relaxed position to avoid forcing (as in compression techniques) a lesion proximate to the skin surface rendering it inaccessible to laser therapy because of the risk of skin necrosis.
• invasive procedures include the introduction of a needle for aspiration biopsy, a rotex screw biopsy needle within a cannula, and a trocar within a cannula.
• Meyerowitz describes the use of a high speed drill for drill biopsy of breast lesions. Hussman suggests its use for approaching breast lesions without substantial breast compression prior to drill biopsy of the lesion itself.
• the goal of successful localization is the guidance of a medical instrument tip to the lesion site determined by imaging.
• MR transparent Materials that do not cause imaging artifacts nor appear on the MR image shall hereinafter be called MR signal-producing.
• An example of an MR transparent material is polycarbonate.
• An example of an MR signal-producing material is Gd-DTPA contained in an MR transparent material. Similar terminology will be employed when discussing other imaging modalities, e.g., nuclear medicine, ultrasound, and X-ray mammography (including computed tomography) .
• the present invention is directed to a localizer for guidance of the tip of a medical instrument to a breast lesion identified by magnetic resonance (MR) imaging.
• the localizer enables breast imaging and medical instrument guidance relative to an MR visible coordinate system.
• Apparatus in accordance with the invention are characterized by an imaging visible coordinate system representing points within an imaging space, apparatus positioned within that imaging space to receive and/or support an substantially noncompressed breast, and at least one array of bores operatively arranged with the coordinate system for guiding a medical instrument along selected paths that traverse the imaging space to place the instrument tip proximate to an imaged lesion.
• the breast supporting and stabilizing apparatus includes a breast shaped cup.
• a plurality of detachable breast shaped cups of different sizes are provided.
• the breast positioning device includes an inflatable bladder to position the breast within a frame.
• a bore array is rotatable to direct the bores along different paths traversing the imaging space.
• a plurality of array members are provided, each removably mounted on the frame and configured to direct its bores at the imaging space along paths having a different spatial angle.
• array members are pivotably carried by the localizer to offer different paths traversing the imaging space.
• array members are configured to conformingly support body portions, e.g., the breast, the axillary tail.
• bore arrays are spatially interleaved to increase their resolution capability.
• array members are slidably carried by a frame to support and stabilize a breast therebetween.
• the MR visible coordinate system includes lumens defined within a frame and an MR signal-producing material contained in the lumens.
• different imaging visible coordinate systems carry Gd-DTPA, a solution including a radioisotope, and a radio-opaque material to be visible when imaged respectively with magnetic resonance imaging, imaging with radioisotope emissions, and X-ray imaging.
• FIGS. IA, IB, and 1C illustrate medical coordinates relative to a breast
• FIG. 2 is an isometric view of a preferred localizer embodiment, in accordance with the present invention
• FIG. 3A is an isometric view of the frame in the localizer of FIG. 2;
• FIG. 3B is a sectional view illustrating removable lumens in the frame of FIG. 3A;
• FIG. 4A is a bottom plan view of the localizer of FIG. 2 including removable walls;
• FIG. 4B is a view of structure the structure within the curved line 4B - 4B of FIG. 4A;
• FIG. 4C is a view similar to FIG. 4B;
• FIG. 5A is an isometric view of the cup in the localizer of FIG. 2;
• FIG. 5B is a reduced view of FIG. 5A including suction structure
• FIG. 6 is a schematic view of a breast volume measurement method
• FIG. 7A is an MR computer display of an imaged lesion and coordinate system
• FIG. 7B is another MR computer display of an imaged lesion and coordinate system
• FIG. 8 is a top plan view of the localizer of FIG. 2 including removable walls and an inflatable bladder;
• FIG. 9 is an isometric view of another preferred localizer embodiment
• FIG. 10 is an isometric view of another preferred localizer embodiment
• FIG. 11 is an isometric view of another preferred localizer embodiment
• FIG. 12A is a side view of a preferred trocar embodiment for use with the preferred localizer embodiments
• FIG. 12B is an end view of the trocar of FIG. 12A;
• FIG. 13A is a side view of a preferred cannula embodiment for use with the trocar embodiment of FIGS. 12;
• FIG. 13B is an end view of the cannula of FIG. 13A;
• FIG. 14A is a side view of the trocar of FIGS. 12 received within the cannula of FIGS. 13;
• FIG. 14B is an end view of the structure of FIG. 14A;
• FIG. 15A is a side view of another preferred trocar embodiment
• FIG. 15B is an end view of the trocar of FIG. 15A;
• FIG. 15C is a side view of another preferred cannula embodiment for use with the trocar of FIGS. 15;
• FIG. 15D is an end view of the cannula of FIG. 16A;
• FIG. 16 is a side view of another preferred tocar/cannula embodiment
• FIG. 17 is an isometric view of another preferred localizer embodiment with a rotatable bore array
• FIG. 18 is a view along the plane 18 - 18 of FIG. 17;
• FIG. 19 is a view along the plane 19 - 19 of FIG. 17 illustrating a polar coordinate guide
• FIG. 20 is a view similar to FIG. 19 illustrating another polar coordinate guide
• FIG. 21 is a view along the plane 21 - 21 of FIG. 17 illustrating a selectable bore array in place of the rotatable bore array of FIG. 17;
• FIG. 22 is a side view of the structure of FIG. 21;
• FIG. 23A is a side elevation view of the selectable bore array of FIG. 21;
• FIG. 23B is a front elevation view of the selectable bore array of FIG. 23A;
• FIG. 24 is a view similar to FIG. 8 illustrating a slidable compression plate
• FIG. 25A is a view similar to FIG. 24 illustrating a slidable bore array and compression plate
• FIG. 25B is a side view of the structure of FIG. 25A;
• FIG. 26A is an isometric view of another preferred localizer embodiment having a slidable floor member
• FIG. 26B is a view along the plane 26B - 26B of FIG. 26A;
• FIG. 27A is a top plan view of a localizer having a conformable bore array
• FIG. 27B is a bottom elevation view of the localizer of FIG. 27A;
• FIG. 27C is a side elevation view of the localizer of FIG. 27A;
• FIG. 28 is a view of the localizer of FIGS. 27 installed on a patient for imaging and localization;
• FIG. 29A is a side elevation view of a preferred localizer embodiment incorporating structure of the embodiment of FIGS. 27;
• FIG. 29B is a top plan view of the localizer of FIG. 29A;
• FIG. 30 is an isometric view of another preferred localizer embodiment illustrating a rotatable arm carrying a bore array
• FIG. 31 is an isometric view of another preferred localizer embodiment illustrating a rotatable arm carrying a bore array
• FIG. 32A is a side view of a drill-biopsy needle embodi ent
• FIG. 32B is an end view of the drill-biopsy needle of FIG. 32A;
• FIG. 33A is an enlarged view of structure within the curved line 33 of FIG. 32A illustrating a sampling end embodiment
• FIG. 33B is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33C FIG. 33B is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33D is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33E is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33F is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33G is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 33H is an enlarged view similar to FIG. 33A illustrating another sampling end embodiment
• FIG. 34A is an enlarged view of structure within the curved line 34 of FIG. 32A illustrating a driven end embodiment
• FIG. 34B is an enlarged view similar to FIG. 33A illustrating another driven end embodiment
• FIG. 35 is a side view of a vacuum syringe embodiment for use with the drill-biopsy needles of FIGS. 32 - 34;
• FIG. 36 is a view similar to FIG. 3A illustrating incorporation of MRI transmit/receive coils in the frame of FIG. 3A.
• Embodiments of the present invention may be directed to a plurality of specific imaging modalities, e.g., MRI, nuclear medicine, and X-ray mammography.
• imaging modalities e.g., MRI, nuclear medicine, and X-ray mammography.
• FIG. 2 is an isometric view of a preferred localizer embodiment 40, in accordance with the present invention, having a frame 42 and a cup 44 carried by the frame.
• FIGS. 3A and 4 are respectively isometric and bottom plan views of the frame 42 and
• FIG. 5 is an isometric view of the cup 44.
• the frame 42 includes an MR signal-producing Cartesian coordinate system 46 and bore arrays 50, 52, and 54 aligned therewith (the array 54 is only partially shown in FIGS. 2 and 3A for clarity of illustration) .
• Each of the bore arrays includes a plurality of bores 60 defined by the frame 42.
• the localizer includes an MR signal-producing reference axis 61 and coordinate axes identifying indicia 62 in the form of x, y, z markers.
• the cup 44 has an inner surface 63 which is shaped and configured to closely receive a breast therein.
• the cup 44 defines a flange 64 extending from the cup rim 66 and a plurality of apertures 68 in the cup wall 69.
• a limited number of apertures are shown but the apertures 68 may extend over the entire cup wall 69.
• the cup 44 is formed of a thin nonferromagnetic, MR transparent material (i.e., one that is nonmetallic and does not produce an MR signal nor an MR artifact as defined in the background section) which is configured and positioned to stabilize the breast therein but which permits free transgression of a needle tip at any point by utilization of a high speed drill for needle insertion, e.g., rigid or pliable materials such as vinyl or plastic. Sterile fabric, paper, foam or a variety of conceivable materials may also be used by those skilled in the art.
• a plurality of cups 44 are provided, each having a different volume defined between the inner surface 63 and the plane of the cup rim 66.
• the volume of a breast 70 to be MR imaged within the localizer 40 would be measured by insertion up to the chest wall 71 in a liquid 72 as shown in the schematic view of FIG. 6.
• the liquid 73 displaced from the container 74 is an accurate measure of volume of the breast 70.
• a cup 44 would then be selected from the plurality of cups in accordance with the measured breast volume.
• the fit between the breast and the selected cup is further enhanced by the contour of the inner surface 63 which is generally breast shaped to define a conforming surface.
• the inner surface may be formed in accordance with molds of actual breasts or formed to define a parabolic shape.
• a surgical grade adhesive 75 e.g., dimethylpolysiloxane
• the adhesive could be applied by an applicator 76 as illustrated in FIG. 5A.
• Other effective application methods may be used, e.g., spraying through a thin tube or coating the interior of the cup.
• suction through an aperture near the cup's inferior surface further enhances a close fit.
• a variety of methods to support the base of the cup relative to the localizer frame can be envisioned including a pillar 77 situated or attached between the inferior surface of the cup 44 and the localizer base as shown in the reduced view of FIG. 5B.
• FIG. 5B also shows the above mentioned suction applied by means of a syringe 78.
• the adhesive can be removed later with medical grade solvents, e.g., trichlorotrifluoroethane.
• the breast and cup 44 are then arranged to have the cup 44 carried by the frame 42 as shown in FIG. 2 with, preferably, the medical grade adhesive 75 also applied between the flange 64 and a lip 77 defined by the frame 42 and between the flange 64 and the chest wall surrounding the breast.
• the localizer 40 and patient are then situated appropriately within an MR unit for imaging of the breast. Typically in this process, the patient lies in a prone position within the MR unit.
• MR breast imaging would then be conducted as briefly described above in the background section and as well known to those skilled in the art.
• This imaging typically includes a fat suppressed 3D contrast-enhanced pulse sequence followed by maximum-intensity-projection (MIP) and rotational reconstruction of lesion coordinates.
• MIP maximum-intensity-projection
• the imaged lesion 79 would appear on the MR computer display along with the MR visible coordinate system 46 of FIG. 2 which serves to define points in an imaging space within the coordinate system. This is illustrated in FIGS. 7A and 7B.
• FIG. 7A represents a zero degree MIP projection of the contrast enhanced lesion 79 within the MR visible coordinate system (46 of FIG. 2) as viewed from above; the x and y coordinate axes 82, 84 are displayed en-face while the reference rod 61 and z coordinate axis 80 appear as points confirming exact zero degree rotation of the MIP projection.
• the x and y lesion coordinates 88, 86 are determined by measurement of perpendiculars to the y and x axes respectively.
• FIG. 7B represents a 90° rotation of the MIP projection of FIG. 7A towards the right, corresponding to a left-lateral view of the coordinate system (46 of FIG. 2) .
• This projection displays the x and z coordinate axes 82, 80 and the reference rod 61 en-face; the y axis rod 84 appears as a point confirming exact 90° rotation.
• the z lesion coordinate 90 is determined by measurement of a perpendicular to the x axis.
• an MR visible marker may be placed proximate to either the x or y axes.
• the reference rod 61 in conjunction with the z axis rod 80, defines the position of the lesion on individual coronal images of the contrast-enhanced fat-suppression MR study, and aids the MR technologist in positioning of slices.
• the nearest corresponding bore 60 can be chosen from any of the bore arrays 50, 52, 54. For example, if bore 60A in the bore array 50 meets this criteria, a medical instrument, schematically indicated by broken line 100, would then be guided through bore 60A until its tip 104 reaches the point represented by the coordinates 88, 86, 90.
• the instrument tip 104 has been guided to the lesion site.
• the localization described above is preferably completed directly after imaging and without movement of the patient and localizer 40.
• the lesion 79 therefore, has not been moved relative to the coordinate system 46 during imaging and subsequent guidance of the medical instrument tip 104 to the lesion site.
• the cup wall 69 is preferably formed as thin as possible to allow easy instrument penetration to minimize disturbance (i.e., maximize stabilization) of the breast subsequent to establishing lesion spacings. If desired, application of adhesive between the breast and cup wall 69 described above may effectively be restricted to those wall apertures 68 surrounding the bore selected in accordance with the imaged lesions spacings.
• Suitable materials to form the cup 44 include plastic, vinyl, paper, particulate matter, foam, mesh and fabric or a variety of other materials conceivable by those skilled in the art.
• the apertures 68 may be omitted. Portions of the cup wall 69 may be omitted to lessen the tendency of the cup material to fold or wrinkle as it follows the breast contour and so that the breast may be seen if non- transparent cup materials are used. For example, quadrants could be removed from the wall 69 so that the remaining material forms an X shaped pattern.
• Means to secure the cup material to permit secure placement of the of the breast include straps placed around the torso of the patient, fasteners of numerous conceivable configurations on the localizer itself, or adhesive.
• the orthogonal Cartesian coordinate axes 80, 82, and 84 (which may be considered to be respectively z, x, and y axes) are lumens (with the same reference number) defined by the frame 42 and filled with an MR visible material 85, e.g., Gd - DPTA liquid or other MR signal-producing material (which may be semisolid) .
• the material in the lumens should be one that will produce an MR signal in all anticipated pulse sequences of the MR imaging.
• the reference lumen 61 is diametrically opposed to (relative to the cup 44) and parallel with the lumen 80 to define another coordinate axis as an aid in identifying the cup area on the MR computer display.
• the frame 42 is formed of a nonferromagnetic, MR transparent material and defines a recess 112 to receive the cup 44.
• the bore arrays 50, 52, and 54 are arranged orthogonally and aligned in operative association with the coordinate axes 80, 82, and 84, i.e. arranged to be directed at an imaging space represented by the coordinate axes.
• Each bore axis defines a selected path that traverses the imaging space.
• the diameter of the bores 60 is selected to closely receive the instrument therethrough without excessive binding.
• Bore diameter and bore length are chosen to minimize deviation of the instrument tip 104 from the selected path of the bore axis as the instrument passes through the bore (it should be apparent that in all embodiment figures, only a few bores of each array have been shown completely for clarity of illustration) .
• the bores of the array 52 in FIG. 4A have a space 141 between their axes.
• Each of these bores can guide the tip 104 of a medical instrument 100 (schematically indicated by the broken line 100) to an imaged location within the imaging space defined by the coordinate system 46.
• the tip 104 is positioned substantially at the far side of this imaging space relative to the bore array 52, i.e., proximate to the wall 138.
• the bores of the array 52 would be configured in diameter and length to guide the tip 104 without any deviation from the bore axis as it traverses the imaging space.
• FIG. 4B is a view of the structure within the curved line 4B - 4B of FIG. 4A and FIG. 4C is a similar view.
• an instrument 100 e.g., a cannula
• FIG. 4C the instrument 100 has been rotated in the opposite direction until the instrument abuts the diametrically opposite bore edges 145, 146. Obviously, this rotation results in deviation of the instrument tip 104 from the bore axis 142.
• the bore diameter can be reduced and/or the bore length extended sufficiently to gui the instrument tip 100 within any selected maximum deviation from the bore axis as it traverses the imaging space. For example, if the selected maximum deviation were one half of the interbore spacing 141, the bore diameter would be reduced and/or the bore lengthened accordingly.
• array indicia 113 are provided on the frame faces 114, 116, and 118. These indicia indicate spacings of array rows and columns from the coordinate axes 80, 82, and 84 compatible with the spacing units used by the computer display.
• the frame 42 is shown in FIGS. 2 - 4 to be integral, it preferably has removable lumens so that in cleaning of the localizer, the MR signal-producing material in the lumens is not subjected to excessive temperatures or other cleaning conditions that might degrade it performance.
• the frame may include removable lumens as shown, for example, in the partial sectional view of FIG. 3B where the frame is relieved along the frame faces 114, 118 and parallel to the lumen 82 to slidingly receive a conformingly shaped strip 119 which defines the lumen 82.
• the spacing between the bores 60 in each array is selected to be as narrow as is practicable with the material and fabrication technique available.
• the arrays 50, 52, and 54 are arranged to be spatially interleaved, e.g., to each have elements such as rows and columns spatially interleaved with elements of other arrays.
• row 120 of the array 54 is interleaved between columns 122 and 124 of the array 50 and column 126 is interleaved between columns 128 and 130 of the array 52.
• row 132 of array 52 is interleaved with rows 134, 136 of the array 50 as shown in FIG. 2.
• the imaging displays shown in FIGS. 7 may provide lesion spacings from all pairs of coordinates, i.e., from pair 80, 82, pair 80, 84, and pair 82, 84.
• An appropriate set of these spacings that most closely guides the instrument tip 104 to the lesion site can be selected.
• the array interleaving described above presents a greater resolution to this selection than would otherwise be available.
• medical instruments e.g., a biopsy needle
• the instrument can be withdrawn from the breast through the selected bore 60.
• some instruments can not, e.g., a hook-wire.
• FIG. 4 illustrates an embodiment variation in which the frame walls 137, 138 that respectively oppose the faces 114, 116 are separate and removable from the remainder of the frame.
• FIG. 8 illustrates another preferred localizer embodiment 150.
• the localizer 150 is similar to the localizer 40 of FIG. 2 but replaces the selected cup 44 with a combination of the interior frame faces 151, 152 and an inflatable bladder 153 disposed adjacent the respectively opposite interior faces 154, 155.
• the embodiment 140 shows removable walls 162, 164 similar to the removable walls of FIG. 4A.
• FIG. 9 Another preferred localizer embodiment 180 is illustrated in the isometric view of FIG. 9.
• the localizer 180 is similar to the localizer 40 but replaces the selected cup 44 with an interior breast receiving surface 182 defined by the frame 184.
• all bores 186 are from the faces 190, 192, and 194 to the interior surface 182.
• the embodiment 180 permits the use of a simple frame to perform localization.
• the teachings of the invention can be extended to another preferred localizer embodiment 240 illustrated in FIG. 10.
• the embodiment 240 includes a housing 242 configured to present an inclined surface 244 against which a patient may comfortably be supported in a prone position within the MR unit.
• the housing 242 is configured to receive a pair of spaced localizers 40 (as shown in FIG. 2) so as to present them along the plane of the inclined surface 244.
• the patient's breasts are received in the localizers 40 as described above. Imaging and guidance of medical instruments is then conducted as described above relative to other embodiments.
• FIG. 11 Another preferred localizer embodiment 280 is shown in FIG. 11.
• the embodiment 280 is similar to the embodiment 240 but its housing 282 incorporates the localizers 40 of the embodiment 240 into a single unit, i.e., the localizers are not removable.
• the cranial and lateral grid faces 284, 286 may be slidingly removed, however, to permit sterilization. Additionally, the lateral edges 288 of the housing 282 and thus, the height of the lateral grid faces 286, may be increased as shown so that lesions closer to the chest wall may be approached laterally.
• the housing 282 also indicates exemplary reliefs 289 that may be designed thereinto by those skilled in the imaging art to accommodate breast imaging coils.
• FIGS. 14A, 14B a preferred trocar/cannula embodiment 300, for use with the localizers disclosed herein, is shown in FIGS. 14A, 14B to have a trocar 302 and a cannula 320.
• the trocar 302 is shown in the side and end views respectively of FIGS. 12A, 12B.
• the trocar 302 has a cylindrical stem 304 that enlarges proximate a driving end 306 to an enlarged portion 303 which defines a stop 308 and, within the stop, a notch 310.
• This driven end and notch may be made of materials that include metal and plastic.
• the end 312 of the trocar terminates in a tip 332 which is preferably coaxial with the stem 304. It may be shaped with axially symmetric facets to minimize cutting forces that would force the trocar away from a penetration axis such as the axis of the bores of the localizer.
• the embodiment 302 defines three cutting facets 314.
• the embodiment 300 also includes a cannula 320 shown in the side and end views respectively of FIGS. 13A, 13B to have a passage 322 dimensioned to closely receive the trocar 302 for rotation therein.
• the cannula defines a tab 326 which is dimensioned to be received in the notch 310 of the trocar 302.
• the cannula defines an annular bevel 330 to minimize penetration resistance.
• Both trocar and cannula are formed from a nonferromagnetic and non artifact- producing material, e.g., titanium or stainless steel with a high nickel content, to be substantially MR transparent.
• the enlarged portion 303 and cannula driven end 324 can be received together in the chuck of a driving apparatus, e.g., an MR-compatible compressed air drill. Engagement between the tab 326 and notch 310 further insures rotation of the trocar and cannula as one unit.
• the trocar/cannula 300 is suitable for guidance through localizer bores (60 in FIG.
• the trocar/cannula 300 outer diameter is selected to be closely and rotatably received within the localizer bores (60 in FIG. 2) .
• Indicia marks 338 may be added along the cannula to serve as indications of insertion depth within the localizer bores. These marks may also include numbers to indicate, for example, millimeter distances from the tip 332. To decrease penetration resistance, it may be preferable to create cutting edges by scooping the trocar facets 314.
• the enlarged portion 303 and cannula driven end 324 may define other shapes well known in the art for maximizing torque transfer thereto from the drill chuck, e.g., it could define a square cross section.
• the trocar can be removed and the cannula 320 is suitably positioned for insertion of other instruments, e.g., a biopsy needle, a hook-wire or a laser fiber.
• other instruments e.g., a biopsy needle, a hook-wire or a laser fiber.
• the passage 322 of the positioned cannula is then substantially free of obstructing tissue.
• a locking mechanism is optional, various equivalent structures can be used to lock the trocar and cannula together for penetration and yet allow subsequent withdrawal of the cannula. For example, in FIGS.
• FIGS. 15A, 15B another trocar embodiment 350 has a constant diameter and defines a tab 352 which is dimensioned to be received in a notch 354 defined in the driven end 356 of the cannula 360 of FIGS. 15C, 15D.
• the tab and notch structures can be equivalently interchanged between cannulas and trocars.
• FIG. 16 illustrates another trocar/cannula embodiment 370 having a cannula 372 with an enlarged head 374.
• the trocar 376 has a similar enlarged head 377 which abuts the head 374 when the trocar is fully received into the cannula 372.
• the heads 374, 377 may be formed of the same material as the shafts or of plastic secured therein. The plastic heads facilitate connection as a single unit and enhance securement in a drill chuck.
• the cannula nd trocar may be locked together by a male or female thread 380 in the head 374 which receives a male or female thread 382 which may be located on the metal shaft 384 itself or on a sleeve extending forward from the head 377 which encloses the trocar shaft 384.
• the sleeve may be locked on the head 374, with female threads located within the head 377.
• Other equivalent locking arrangements between the trocar and cannula may be devised by those skilled in the art.
• the annular faces 386, 387 may define surfaces that rotationally grip each other. Exemplary surfaces would include ones that are undulating, zigzag and roughened.
• FIG. 17 illustrates a preferred localizer embodiment 400 in which the upper row of the bore array 401 has been replaced by a rotatable array 402.
• the bore array 402 (consisting, in this embodiment, of a single row) is defined in a rotatable frame member in the form of a pivot bar 404 and the frame 406 is relieved along contour 410 to receive the pivot bar 14 therein.
• the pivot bar 404 particularly facilitates insertion of a medical instrument to lesions that are deeper than the chest wall which is typically abutted by the frame lip 412 during imaging and localization (it should be understood from the disclosure above that the imaging space defined by the frame's coordinate system extends past the frame lip 412) .
• FIG. 18 is an enlarged view along the plane 18 - 18 of FIG. 17.
• FIGS. 17 and 18 show a medical instrument, schematic- ly indicated by the broken line 414, inserted through a bore 416 to where the instrument tip 420 has been guided to the coordinates of a lesion site determined during breast imaging with the embodiment 400.
• FIG. 18 also indicates a pivot pin 422 for mounting of the pivot bar 404 to the frame wall 424.
• the x lesion coordinate determined during imaging would be used in selecting the bore of the pivot rod 404 for insertion of the medical instrument 414.
• the y, z coordinates would be transformed by standard trigonometric relations to polar coordinates r, theta. With these coordinates, the pivot bar 404 is then set at the angle theta (reference number 432 in FIG. 18) and the medical instrument inserted through the selected bore by a distance r.
• the transformation to polar coordinates is performed by obtaining a dimension z' which is the imaged coordinate z less the vertical distance from the lumen 82 to the pivot pin 422.
• rotatable array embodiments may be formed in which the pivot bar 404 and frame 406 are modified to convert any row or partial row or any column or partial column of the arrays 401, 428, and 430 to a rotatable array.
• FIG. 19 is a view along the plane 19 - 19 of FIG. 17 illustrating a protractor 440 that includes pins 442 which can be inserted into a selected column of the bore array 401 shown in FIG. 17.
• Rotational indicia 444 on the protractor 440 facilitate alignment of the pivot bar 404 and an inserted medical instrument 414 in accordance with the derived lesion angle theta.
• FIG. 20 is a view similar to FIG. 19 showing a laser 450 installed in a bore of the pivot bar 404 so that it directs a laser beam 451 onto a reference rod 452 extending from the frame 406.
• Knowledge of y, z and the structural distance 453 are sufficient to determine distance 454 along the reference rod so that there is no need to directly calculate the angle theta.
• the pivot bar 404 may simply be rotated until the laser beam 451 strikes an indicia 460 at the distance 454 along the reference rod 452.
• the laser beam 451 may be directed to the pivot bar 404 from a remotely located laser via an optical fiber.
• a laser source is often associated with MR units so that a laser beam could be provided therefrom rather than from a separate laser source as shown in FIG. 20. Therefore, a structure equivalent to that shown in FIG.
• 20 could be an optical fiber routed from a remote laser to have its termination mounted in the pivot bar 404 in place of the laser 450. It should also be understood that various equivalent distance indicating structures may be substituted for the reference rod 452, e.g., a plate or sheet extending from the frame 406 or even any structure separate from the frame having indication of known distance therefrom.
• FIG. 21 is a view along the plane 21 - 21 of FIG. 17 illustrating the pivot bar 404 replaced by a frame member in the form of a selectable array block 480 while FIG. 22 is a side elevation view of the structure of FIG. 21.
• FIGS. 23A and 23B are respectively side and front views of the array block 480.
• the array block is shown to define an array consisting of a single row 484 of bores at an angle 486 to the mounting surface 488. This angle is the angle theta derived above from the imaging coordinates y, z'.
• the array block defines a pair of tenons 490, extending downward from the mounting surface 488, which are slidingly received in a matching pair of mortises 492 cut in the frame 494 to end short of the frame face 496.
• the array block 480 is thus automatically positioned when it is inserted to where the tenons 490 abut the end of the mortises 492.
• a series of array blocks 480 would be provided, each having bores directed along a different spatial angle theta, e.g., in steps of one degree.
• a given array block would then be selected in accordance with the derived angle theta.
• Mortises would then be selected to receive the array block so that one of the bores of the array 484 is positioned as close as the bore resolution permits to the x coordinate found during imaging.
• a medical instrument 414 can then be inserted through the selected bore by a distance r (or a compensated distance calculated from the face 498 of the array member) .
• Various structures functionally equivalent to the mortises 492 and tenons 490 may be easily devised by those skilled in the art to facilitate insertion of array blocks into the frame.
• selectable alignment bore array embodiments may be formed that convert any row or partial row or any column or partial column of the arrays 401, 428, and 430 (see FIG. 17) to a selectable alignment array.
• FIG. 24 is a view similar to FIG. 8 in which an inflatable bladder 499 (similar to the bladder 150 of FIG. 8) is combined with a plate 500 sliding within the bore frame 502.
• a breast may be stabilized for imaging and localization by compression between the plate 500 and the frame face 512 when the bladder 499 is expanded as indicated by the broken line 513.
• These embodiments may be used without entrapment of the breast since, if adhesive is not used, the breast may be freely removed without causing pain to the patient.
• the degree of breast compression is minimal and serves only to eliminate free space within the frame recess and to locate the grid face proximate to the skin surface.
• the localizer 520 includes a slidable plate 522 and a slidable frame member 524 within a U shaped frame 526 in which the frame member defines a bore array 525. Movement of the plate 522 and frame member 524 may be stabilized by vanes 528 extending therefrom to be slidably received in slots 530 and 532 cut respectively in frame inner faces 534, 536, and floor 538. Alternatively, the elements 528 may be rollers which are rotatably received in arcuate grooves 530, 532. Similar movement structure may be provided for the plate 500 of FIG. 24. Movement of plates may be accomplished by inflatable inserts or mechanically by a number of methods known to those skilled v.! the art.
• the patient's breast would be minimally compressed between the slidable bore array 525 and the plate 522 (or between the plate 500 and frame face 512 of the localizer 510) after which imaging and localization would proceed as disclosed above.
• the positions of the bore array 525 and plate 522 relative to the frame 526 may be locked by any conventional means, e.g. thumb screws, latches.
• FIG. 26A Another preferred localizer embodiment 560 that includes apparatus directed to breast stabilization is illustrated in FIG. 26A.
• the localizer 560 is similar to the localizer frame 42 of FIG. 3 but carries a compression plate 562 within the recess 564.
• An inflatable bladder 566 is disposed between the compression plate 562 and the floor 568. Inflation of the bladder 566 can cause the compression plate 562 to move vertically as indicated by the double headed arrow 570 to vary the spaced relationship between the plate 562 and the floor 568.
• a variety of mechanism may be used to cause vertical movement of the compression plate.
• the patient's chest wall would abut the upper lip or face 572 allowing the breast to depend within the recess 564.
• the bladder 566 is then inflated to push the compression plate 562 upward to support and stabilize the breast.
• an MRI volume imaging coil is disposed about the localizer 560.
• a surface coil may be adjacent the lower face 574 of the compression plate 562. Thus, the surface coil would remain adjacent the breast as the compression plate 562 rises.
• the x, y coordinate system lumens 576, 578 may be snapped into selected ones of a plurality of vertically spaces grooves. Thus, the lumens may be placed adjacent the upper face 579 of the compression plate 562. This is illustrated in FIG. 26B which is a view along the plane 26B - 26B of FIG. 26A.
• the x coordinate lumen 576 is received into a selected one of the vertically spaced grooves 580 defined in the face 581. If desired, the grooves 580 can be undercut to further enhance retention of the lumens.
• the lumen 576 (and lumen 578) may be carried in the movable compression plate 562 as shown in FIG. 26B.
• the compression plate 562 may be closely fitted to the walls of the recess 564 and have sufficient vertical thickness to be guided and restrained by the recess walls to be orthogonal thereto.
• Nonmetallic ball or roller bearings 582 may be carried in the sides of the compression plate 562 to reduce friction between the plate and the recess walls.
• the bladder 566 may carry stiffening plates 584, 585 on each side thereof. These plates ensure that the upper surface of the bladder defines a plane to thereby exert a uniform pressure along the lower face 574.
• a medical instrument can be guided to an imaged lesion through bores 586 in bore arrays 588, 589 while movement of the breast is limited by the compression plate 562 and the inner walls of the recess 564.
• FIGS. 24, 25, and 26 are especially suited for use where breast compression techniques are considered necessary.
• Other movable array embodiments may be formed in equivalent ways to convert any bore array (e.g., bore arrays 50, 52, and 52 of FIG. 3A) to a linearly movable array.
• Preferred embodiments of the invention include localizers having bore arrays conformed to body portions associated with the breast. Such an embodiment is shown in FIG. 27 and shown installed over a body portion in FIG. 28.
• the localizer 600 illustrated in plan, bottom elevation, and side elevation views respectively of FIGS. 27A, 27B, and 27C, has an MR visible coordinate system formed by lumens 602, 604, and 606.
• lumens are filled with an MR visible material to create an imaging coordinate system functionally similar to that of the lumens 80, 82, and 84 of the frame 42 of FIG. 3A.
• the lumens are defined within a frame member 608 which also defines a bore array 610 arranged in operative association with the coordinate system.
• the lower face 612 of the frame member 608 is shaped to conform to the axilla and the adjacent pectoralis muscle. Specifically, a face portion 614 is shaped and spaced from the frame upper face 616 to conform to the axilla and a face portion 618 is shaped and spaced more narrowly from the face 616 to conform to the pectoralis muscle.
• the lower face 612 descends along one side of- he frame member 608 to form a side plate 619 that contains the lumen 606. • • • • In use, the localizer 600 would be placed on a patient 620 as shown in FIG. 28.
• the lower face 612 abuts the patient with the face portion 614 received in the axilla hollow and the side plate 619 extending downward along the side of the patient 620.
• a medical adhesive may be placed between the patient and the lower face 612 to reduce movement therebetween.
• straps 622 may extend from the localizer to enclose the patient's body.
• a flat rf imaging coil may be located above the localizer.
• the localizer 600 is particularly intended to image and localize nodes within the axilla for needle biopsy sampling and lesions within the "Tail of Spence" (axillary tail) .
• Other embodiments may have bore arrays shaped to conform with other specific body regions, e.g., the neck, the abdomen.
• Conformable structures and bore arrays therein similar to the localizer face 612 of FIGS. 27 may be combined with structures similar to the localizer 180 of FIG. 9 to form the localizer 640 illustrated in the side and top views respectively of FIGS. 29A, 29B.
• the frame 642 of the localizer 640 defines, in its upper surface, an arcuate, e.g., parabolic, breast receiving depression 644 similar to the surface 182 of FIG. 9.
• the frame 642 also defines an arm 646 extending cranially and laterally relative to the remainder of the frame body.
• the floor 647 of the frame rises to define the floor 648 of the arm 646.
• the arm 646 defines an upper surface 650 shaped similar to the face 612 of the FIGS. 27A, 27B, i.e., to conform with the axilla and the adjacent pectoralis muscle.
• the surface 650 includes a downward extending trough 651 shaped to received a pectoralis muscle and the overlying axillary tail (tail of Spence) therein.
• the trough 651 transitions laterally and caudally into an upward swelling mound 652 shaped to fill the axilla region.
• the surfaces 644, 651, and 652 smoothly transition into each other.
• the side wall 654 rises to an upper margin 657 that is higher than the remainder of the frame 642 (indicated by broken line 658) . This upper margin 657 transitions smoothly laterally and cranially into the mound 652.
• the side wall 654 defines a horizontally directed bore array 655 therein (the array is only partially shown in FIG. 29B for illustration clarity) .
• the bores of this array open into the lateral side of the depression 644.
• the side wall 654 transitions at an angel into the side wall 656 of the arm 646.
• the arm 646 defines a vertically directed bore array 659 which opens into the anterior surfaces of the mound 652 and trough 651 (the array is only partially shown in FIG. 29B for illustration clarity) .
• Lumens 662 and 663 in the side wall 654 respectively define coordinate axes z and y while a lumen 664 extends orthogonally away from the side wall 654 to define an x axis coordinate.
• Another lumen 666 in the side wall 656 defines y' coordinate axis while a lumen 668 extending orthogonal to the side wall 656 defines an x' coordinate axis
• the lumens 666, 668 are contained above the raised arm floor 648.
• the localizer 640 would be arranged so that the arm 646 extends cranially and laterally relative to a patient.
• the patient's breast would be received into the depression 644 and the axially tail (tail of Spence) and underlying pectoralis muscle received in t e trough 651.
• the upward extending mound 652 would fill -che axilla region.
• medical instruments can be inserted to reach lesion sites through bores selected in accordance with the imaging. Lesion sites within the breast would generally be located relative the lumens 662, 663 and 664 and reached through the bore array 655 while lesions in the tail of Spence would generally be located relative to the lumens 662, 666 and 668 and reached via the bore array 659.
• the upward extending side wall 654 facilitates the approach of lesion sites above the chest wall with the bore array 655.
• the surfaces 644, 651 and 652 may also be defined in an insert that is formed of a thin nonferromagnetic, MR transparent material and the insert removably mounted within a frame in a manner similar to the cup 40 and frame 42 of the localizer 40 of FIG. 2.
• FIGS. 26 may be incorporated with the localizer 640 of FIGS. 29. That is, a compression plate and bladder similar to the compression plate 562 and bladder 566 of FIGS. 26 may be used. The compression plate would be shaped to conform to the surfaces 644, 651 and 652.
• FIG. 30 is an isometric view of a localizer 680.
• the localizer 680 has a frame 682 similar to the frame 42 of FIG. 3A but with two opposing walls removed to leave a U-shaped frame that defines a recess 683 therebetween.
• Bore arrays 684, 686 are defines in the two remaining spaced and opposed walls 688, 690. Each bore 691 in one of these arrays is coaxial with a bore of the opposed bore arrays.
• the walls 688, 690 are connected by the 5 orthogonally arranged floor 692 and a pin 694 pivotally attaches the floor 692 to a supporting housing.
• the supporting housing is not shown for clarity of illustration but could be similar to the housing 242 of FIG. 10. Such a housing could also carry a protractor 695 for measuring the
• (coordinate axes) 696, 697, 698 and 699 are defined by the frame 682 similar respectively to the lumens 80, 82, 84 and 61 of the frame 42 of FIG. 3A.
• a U-shaped arm 700 includes a bar 702 carried between
• Each inner end of the legs 704 has a pin 706 and the pins 706 are each coaxial with an imaginary axis 708 therebetween.
• a transversely arranged bore array 710 is defined in the bar 702. Each bore 712 of the bore array 710 is directed radially away from the axis
• the pins 706 can be removably inserted into selected coaxial bores of the opposed bore arrays 684, 686. To facilitate this
• the pins 706 can, for example, be spring loaded in the legs 704 and moved axially in and out by means of a knob 718.
• Arm 700 may employ several rows of bores, each directed towards the pivot axis. Although the bores are preferably directed at the pivot axis 708, the
• 30 arm 700 may carry bores with other alignments.
• a breast is positioned within the recess 683.
• the breast may be stabilized with the aid of structures disclosed above, e.g., a cup similar to the cup 40 of FIG.
• 35 2 could be carried from the lips 720.
• Bores would be selected in bore arrays 684, 686 in accordance with the imaging data relative to the 696, 697 coordinates (i.e., the opposed bores whose axis 708 most nearly intersects the imaged lesion are selected) and the pins 706 inserted therein.
• a bore of the bore array 710 is selected in accordance with imaging data relative to the 698 coordinate (i.e., the bore nearest the y axis location of the lesion is selected) .
• a medical instrument is placed in the selected bore in the bore array 710 and inserted, from the face 714 a distance equal to the distance 716. This will place the tip of the medical instrument proximate to the center of the lesion.
• the arm 700 can be rotated about its mounting pins 706, as indicated by the arrow 721, to select a specific path from the selected bore to the lesion, e.g., a path that allows sampling of the lesion at a different angle by drill-needle biopsy. Because the pin axis 708 has been aligned with the lesion, the arm 700 can be placed at any angle and an insertion depth of distance 716 will still place the medical instrument tip proximate to the lesion.
• Each of the opposed bores, selected in the bore arrays 684, 686 in accordance with the imaging data, can also be used directly for guidance of a medical instrument to the imaged lesion site.
• the instrument is inserted a depth selected in accordance with the imaging data relative to the 698 coordinate.
• the frame 682 can also be pivoted about the pin 694 to select a specific path from any of the bore arrays 684, 686 or 710 to the imaged lesion. If the frame 682 is pivoted at an angle 0 between imaging and localization, the imaged lesion coordinates must be converted accordingly. To simplify this conversion, the zero indicia indications on the coordinate axes 697, 698 are aligned with the pivot pin 694 as indicated by broken lines 722, 724.
• the localizer 680 may also include an upward directed bore array in the floor 692 similar to the bore array 54 of FIG. 2. Additionally, other embodiments of the invention may have bore array carrying arms that are pivotably mounted in selected bores of this floor array rather than in the wall arrays as illustrated in FIG. 30.
• FIG. 31 shows a plate 740 similar to the 5 floor 692 which defines a bore array 742.
• the plate 740 may be a separate plate or may represent the floor 692 of the localizer 680 of FIG. 30.
• An arm 744 has a downward extending pin 746 at its inner end and defines a pair of horizontally spaced upward extending guides 748, 750 at its
• Each of the guides 748, 750 defines a vertically oriented recessed track 752.
• Slidably mounted in the tracks 752 is an array block 754 which carries a bore array 756 oriented in a horizontal plane.
• Each bore 758 in the bore array 756 is directed inward and rotated
• the face 762 of the array block is curved so that any point in the face is a horizontal distance 763 from the pin axis 760.
• the array block 754 slides up and down in the tracks 752 as indicated by the
• the plate carries lumens 697, 698, and 699 similar to the identically numbered lumens of FIG. 30.
• the upward extending lumen 699 would be in the localizer 680 if the plate 740 is the floor 692 thereof. Otherwise, the plate
• 25 740 may define an upward extending portion 766, shown in broken lines, to carry the lumen 699.
• a bore can be selected in bore array 742 in accordance with the lesion imaging data relative to the 697, 698 coordinates and the
• the array block 754 is adjusted to vertically align each bore 758 with the imaged lesion in accordance with imaging data relative to lumen 699. Indicia such as the marks 768 may be provided to aid this alignment.
• the array block 754 may carry bores either
• the array block 754 may carry bores with other alignments. Several rows of bores may also be employed.
• a medical instrument may then be placed in any bore of the bore array 756 and inserted, from the face 762 a distance equal to the distance 763. This will place the tip of the medical instrument proximate to the center of the lesion.
• Different bores of the bore array 756 may be selected and/or arm 744 can be rotated about its mounting pin 746, as indicated by arrow 765, to select a specific path from the selected bore to the lesion, e.g., a path that intersects a different part of the lesion. Because the pin axis 760 has been vertically aligned with the lesion, the arm 744 can be placed at any angle and an insertion depth of distance 763 will still place the medical instrument tip proximate to the lesion.
• the inner end of the arm 744 is shown to lie above the plate 740. As indicated by broken liens 770, the arm 744 could also be mounted below the plate 740 with the pivot pin 746 directed upward into the bore array 756. This arrangement would avoid interference with the breast or breast supporting structures above the plate 740.
• a thin membrane 772 (shown in broken lines) may be carried above the plate 744 to space the breast from the arm 744.
• the bore selected in the bore array 742 (or arrays 684, 686 in the localizer 680 of FIG. 30) in accordance with the imaging data can also be used directly for guidance of a medical instrument to the imaged lesion site.
• the instrument is inserted a depth selected in accordance with the imaging data relative to the 699 coordinate when using the array 742 and relative to the coordinate 698 when using the arrays 684, 686.
• the arm 744 and plate 740 form part of the localizer 680 of FIG. 30, i.e., the plate 740 represents the floor 692 of the localizer, the opposed open ends of the U-shaped frame 682 allow passage of medical instruments from the array block 754 to imaged lesion sites.
• Other equivalent localizer frames may be visualized to provide access between the array block 754 and imaged lesion sites, e.g., an L-shaped localizer frame including the floor 692 and one of the walls 688, 690 of the frame 682.
• the arms 700, 744 can be installed subsequent to imaging, they do not necessarily have to be made of MR transparent material.
• Trocar/cannula embodiments associated with the invention were disclosed above and illustrated in FIGS. 12 - 16. As stated above relative to those figures, after the tip of a trocar, e.g., trocar 350 of FIG. 15A, has been positioned proximate to the lesion site, the trocar can be removed and its associated cannula, e.g., cannula 360 of FIG. 16A, is suitably positioned for insertion of other instruments.
• a trocar e.g., trocar 350 of FIG. 15A
• an insertable medical instrument is an emulsifier (morecelator) .
• Another example of an insertable instrument is the hollow drill-biopsy needle 780 illustrated in side and end views respectively of FIGS. 32A and 32B.
• the biopsy needle 780 is similar to the trocar embodiment 350 of FIGS. 15. Accordingly, the needle 780 defines a driven end 820 (having a tab 782) which is dimensioned to be received in the chuck of a high-speed drill.
• the driven end 820 may be augmented by metal or plastic (similar to the cannula/trocar 370 of FIG. 16) and may have various dimensions all of which permit optimal stabilization of the needle by the drill chuck.
• the needle 780 can be inserted into the cannula 360 with the needle sampling end 784 extending out of the cutting end of the cannula and into the imaged lesion.
• the length of the biopsy needle should be longer than that of the cannula/trocar.
• FIGS. 33A - 33H are enlarged views of the sampling end 784 (structure within the curved line 33 of FIG. 32A) that illustrate irregularities directed to retention of lesion tissue.
• FIG. 33A shows a beveled cutting edge 786 at the sampling end 784.
• FIG. 33B shows a roughened surface comprising random irregularities 788 defined in the interior of the sampling end 784. The irregularities may extend radially inward from the interior surface 790 to ⁇ form tiny bumps or extend radially outward to form small pits.
• FIG. 33C shows 5 random scroll lines 792. Similar to FIG.
• FIG. 33B illustrates these lines may extend radially inward to form ridges or radially outward to form grooves in the interior surface 750.
• FIG. 33D illustrates a slanted hole 794 defined in the wall of the sampling end 744.
• FIG. 33E illustrates annular barbs
• FIG. 33F illustrates annular grooves 798.
• FIG. 33G shows focal, i.e., local in nature, steps 800 and barbs 802.
• FIG. 33H illustrates cutting tabs 804 extending axially from the sampling end 784 to form a trephine.
• the irregularities may be formed of either metal or plastic and
• the needles themselves, as well as the trocar/cannula, may be made entirely of synthetic material such as reinforced plastic.
• the biopsy needle 780 is driven by a high-speed drill
• sampling end 784 is extended past the cannula (preferably positioned at the margin of the lesion) and into the lesion tissue.
• the sampling end 784 thus cuts a core sample of the lesion. Retention of this sample is enhanced by the irregularities. Since withdrawal of the needle may permit
• aspiration is preferably employed to pull the sample into the needle shaft prior to needle removal from the breast.
• a vacuum syringe 810 which facilitates retention of
• the syringe 810 has a plunger 812 within a cylinder 814 which terminates in a reduced end 816. When the plunger 812 is withdrawn from the cylinder end 816, a partial vacuum is created inside the cylinder 814.
• FIGS. 34A, 34B are enlarged views of the structure within the curved line 34 of FIG. 32A.
• FIG. 34A illustrates the same driven end shape of FIG. 32A while FIG. 34B illustrates that the driven end terminates in a beveled tip 822 which facilitates penetration of the diaphragm 818.
• the localizer structures taught in the present invention may incorporate therein transmit/receive coils well known in the MRI imaging art for generating rf excitation signals and receiving the tissue emitted response signals.
• these coils typically include surface coils, whole-volume coils (in solenoid, saddle and birdcage configurations) , partial-volume coils, intracavitary coils and coil arrays.
• FIG. 36 illustrates a frame 840 similar to the frame coil 42 of FIG. 3A with transmit/receive quadrature coil set 842 contained therein.
• the frame 840 has medial and lateral walls 846, 848 and cranial and caudal walls 850, 852 extending upwards from a floor 854. These directions are also indicated by the medially directed arrow 860, the laterally directed arrow 862, the cranially directed arrow 864 and the caudally directed arrow 866.
• the coil set 842 includes a single turn coil 870 of copper wire or band which has sides 876, 878 respectively disposed within walls 846,848 and ends 880, 882 respectively disposed within walls 850, 852.
• One microfarad capacitors are typically located at several points along the coil to enhance RF signal characteristics.
• a similar coil 884 is disposed within the frame walls but rotated to have its sides 886, 888 vertically spaced from the sides of the turn 870.
• Isolated leads 890, 892 provide independent connection to the coils (typically through a diode) .
• the coils 870, 884 carry currents in quadrature, i.e., 90 degrees out of phase and are controlled with quadrature circuit boards within or external to the frame 840.
• the coils 870, 884 are shown integrally molded into the frame 840, they may be carried by the frame in other equivalent ways, e.g., mounted with spacers to the external wall faces.
• the crossed coils 870, 884 are each shown in FIG. 36 to have a rectangular shape. In other embodiments, the coils may be of the crossed ellipse type in which each coil defines an elliptical shape.
• the preferred embodiments have been illustrated with reference to the specific imaging modality of magnetic resonance imaging.
• the inventive concept is generally directed to a variety of imaging modalities.
• the coordinate systems are configured to carry an MR signal-producing material but they generally would be configured to be visible in the selected imaging modality.
• a first example of another selected imaging modality is nuclear medicine in which emissions of radioactive substances are typically used to interrogate a patient's tissues.
• the coordinate systems of the invention are accordingly modified to carry a radioisotope that is visible to nuclear medicine detectors, e.g., a scintillation camera.
• a dilute solution of the radioisotope injected in the patient would be used because the detectors would generally be compatible with that radioisotope.
• the breast would then be imaged using techniques well known in the nuclear medicine art (described, for example, in Introductory Physics of Nuclear Medicine. Chandra, R. , Lea & Febiger, Philadelphia, 1987, the disclosure of which is hereby incorporated by reference) .
• a first exemplary use of the invention in nuclear medicine imaging would include placing a small rectangular parallel hole collimator and detector positioned parallel to the grid faces (e.g., the faces 114 and 116 of FIG. 1) sequentially or placing two such collimators and detectors on the x, z and y, z grid faces simultaneously.
• Radioisotopes currently known to be breast-cancer-avid include Tc99m Sestamibi and Thallium-201 (as reported, for example, by R. J. Campeau, et al., "Concordant Uptake of Tc-99m Sestamibi and TI-201 in Unsuspected Breast Tumor," Clinical Nuclear Medicine. 1992(12): p 936, 937, the disclosure of which is hereby incorporated by reference) .
• Detectors providing high spatial resolution such as solid-state designs may be employed.
• SPECT single photon emission computed tomography
• MIP maximum-intensity- projection
• the teachings of the invention may be extended to X-ray mammography or CT scanning by configuring the coordinate system to be visible therein.
• the coordinate system could include radio-opaque rods such as rods that carry an iodinated contrast material.
• corrections for parallax must be corrected to align the imaged lesion in reference with the central ray, e.g., using trigonometric calculations from a plurality of angled views.
• ultrasound may be used to determine a lesion's coordinates from three grid faces defining x,z; y,z; and x,y planes.
• the location of the ultrasound transducers comprises the visible coordinate system, i.e., distances to an imaged lesion are referenced to each transducer face which defines one of the above mentioned planes. Needle insertion may then proceed as described herein.
• the frame would be of a material transparent to the ultrasound.
• the transducers may be positioned, e.g., hand held, adjoining the frame array faces.
• the frame was formed of lucite with 2 millimeter diameter mineral oil filled lumens (mineral oil was used because no fat suppression sequences were anticipated) .
• the array bores were .040 inch (1.016 millimeters) in diameter, 4 millimeters long, and spaced 5 millimeters apart.
• a phantom target cube of adipose tissue having 5 millimeter sides was held within a larger (11 x 11 x 6 cm) foam phantom disposed within the frame.
• the prototype was imaged within the head coil of a 1.5 Tesla system (Signa; GE Medical Systems, Milwaukee, Wisconsin) and spacings from the coordinate system rounded to the nearest 5 millimeters. Using these coordinates, a 19.5 gauge (.983 millimeter) core-biopsy gun (Argon
• localizer embodiments have been disclosed herein especially suited for guidance of medical instrument tips to a breast lesion site in accordance with lesion spacings derived with the aid of imaging visible coordinate systems.
• trocar/cannula embodiments suitable for use with the localizer embodiments have been disclosed.
• Preferred embodiments also include bore arrays configured to be rotated, linearly moved, selected for alignment, conformed to patient body regions, and carried on pivotable arms.
• Embodiments of the invention directed to the use of substantially noncompressed breast techniques offer several potential advantages.
• the cup 44 is selected to closely receive and support the patient's breast during both imaging and instrument guidance.
• the breast is not subjected to discomfort resulting from pressure or distortion as in some present stabilization techniques which use more than minimal compression between plates. Possible rupture or other damage to a breast implant is also avoided.
• the breast is supported while in the localizer, the breast tissue may be presented without compression to minimize interference with contrast dynamics and subsequent diagnostic interpretation.
• relative movement between the breast and inserted markers e.g. , hook-wires, carbon trails
• access to breast lesions may be obtained through each bore array.
• this feature also offers instrument guidance perpendicular to the chest wall, e.g., through bore array 54 of FIG. 2, which may be advantageous in reaching lesions near the chest wall.
• bore arrays may range from a single row or column each consisting of at least one bore to a plurality of rows and/or columns of bores, i.e., the term array, in general, is defined to be a systematic arrangement of elements.
• useful arrays may also include arrangements other than distinct rows and columns.
• embodiment lumens have generally been shown to be elongated, it should be understood that the teachings of the invention (and the definition herein of the term lumen) extend to lumens of other shapes and sizes that define a coordinate system, e.g., an elongated lumen between two end points could equivalently be replaced with small cylindrical lumens defining only the end points.
• frame refers to an integral frame that defines elements such as lumens and bores as well as frames made up of a plurality of parts, some of which define these same elements.
• the preferred embodiments have shown Cartesian coordinate systems with orthogonal bore arrays arranged orthogonally with these systems. It should be apparent, however, that the teachings of the invention extend to any coordinate system, e.g., cartesian or polar, and any bore arrays that are arranged in operative association therewith, i.e., arranged to be directed at an imaging space represented by the coordinate system. Preferably the bore arrays are arranged to make it easy for operators to use the imaging determined lesion spacings in selecting appropriate guide bores.
• the preferred embodiments of the invention described herein are exemplary and numerous modifications, rearrangements, and combinations thereof can be readily envisioned to achieve an equivalent result, all of which are intended to be embraced within the scope of the appended claims.

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Cited By (7)

• 1994
  • 1994-09-19 AU AU77320/94A patent/AU7732094A/en not_active Abandoned
  • 1994-09-19 WO PCT/US1994/010651 patent/WO1995008293A2/fr active Application Filing

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