EP1180963A1 - Systemes et procedes permettant de cibler une lesion du sein - Google Patents

Systemes et procedes permettant de cibler une lesion du sein

Info

Publication number
EP1180963A1
EP1180963A1 EP00928767A EP00928767A EP1180963A1 EP 1180963 A1 EP1180963 A1 EP 1180963A1 EP 00928767 A EP00928767 A EP 00928767A EP 00928767 A EP00928767 A EP 00928767A EP 1180963 A1 EP1180963 A1 EP 1180963A1
Authority
EP
European Patent Office
Prior art keywords
lesion
breast
representation
surgical
mammograms
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP00928767A
Other languages
German (de)
English (en)
Inventor
Zachary S. Spigelman
Richard H. Theriault
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotrack Inc
Original Assignee
Biotrack Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotrack Inc filed Critical Biotrack Inc
Publication of EP1180963A1 publication Critical patent/EP1180963A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61B6/50—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications
    • A61B6/502—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications for diagnosis of breast, i.e. mammography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0825—Detecting organic movements or changes, e.g. tumours, cysts, swellings for diagnosis of the breast, e.g. mammography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • 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
    • 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
    • A61B6/04—Positioning of patients; Tiltable beds or the like
    • A61B6/0407—Supports, e.g. tables or beds, for the body or parts of the body
    • A61B6/0414—Supports, e.g. tables or beds, for the body or parts of the body with compression means

Definitions

  • the present invention relates generally to systems and methods for directing a surgical instrument into a position relative to a tissue area whose position has been preselected. More specifically, the present invention relates to systems and methods adapted for directing a surgical instrument into a position relative to a lesion in the breast.
  • Palpable lesions are accessible by techniques commonly available in the medical arts, including the use of percutaneous techniques and the use of open surgical techniques.
  • Percutaneous techniques involve the use of a medical device to reach a tissue area located beneath the skin surface without incising the tissues to approach the tissue area directly.
  • Percutaneous techniques in surgery can include the formation of a skin incision through the epidermis and the dermis for the purpose of facilitating the introduction of the medical device through the skin, though the remainder of the delivery of the device to the tissue area takes place without further incisional exposure.
  • Percutaneous techniques as applied to the breast include core needle biopsy and fine needle aspiration biopsy.
  • Open surgical techniques are understood to involve the use of surgical methods to approach the tissue area directly. Surgical methods include incising the skin, and further include carrying the approach beneath the skin level to the area of tissue to be removed. Surgical methods include dissection, either sharp or dull, through an area of tissue. When a tissue area is palpable, the operator identifies the pertinent tissue area by palpation and uses this identification to guide the medical instrument to the desired area relative to the palpable tissue area.
  • tissue area When a tissue area is not palpable, other methods must be employed to identify its location and guide the medical instrument thereto.
  • non-palpable tissue areas can be identified through mammography and ultrasound.
  • Other modalities available in the medical arts for the identification of tissue areas include CT scan and MRI, each with applicabilities well known in the medical arts.
  • mammography is commonly employed to diagnose tissue areas that may contain possible foci of pathological changes that are cancerous or precancerous. Mammography permits the recognition of pathological tissue areas before they develop into palpable masses that may indicate more advanced cancers.
  • an abnormal area is identified by mammography, further diagnosis may be required. Such diagnosis may include a biopsy.
  • a biopsy may be performed percutaneously or through an open surgical procedure. Either type of biopsy typically includes a way to localize the tissue area to be targeted with the biopsy device.
  • a tissue area of concern for a biopsy is termed a lesion.
  • a palpable lesion can be localized by palpation.
  • a non-palpable lesion that has been identified by mammography may be approached percutaneously for biopsy using mammography methods for guidance. If a percutaneous technique is used, the breast can be held in an apparatus that compresses it and that permits its radiological examination as a biopsy needle is directed towards the lesion. Mathematical methods to determine the location of the tissue area within the compressed breast allow more precision in directing the needle to the tissue area.
  • a preliminary procedure such as a needle localization in which a needle tip is placed by the radiologist in the tissue area that has been identified mammographically.
  • the patient is taken to the mammography suite before the surgical biopsy for the placement of a guiding needle.
  • the patient is placed in a mammography machine, with her breast in mammographic compression.
  • An upper compression plate containing an opening with a superimposed localizing grid is centered over the breast lesion.
  • a mammography is performed in two perpendicular directions with the suspicious lesion placed in the opening of the grid.
  • a radiologist uses the grid seen on the mammograms to guide the placement of the prelocalization needle.
  • a prelocalization needle is directed to the tissue area.
  • the position of the needle is verified relative to the area requiring biopsy. Multiple needle positionings and mammographic confirmations may be required.
  • a small wire with a hook at its end called a wire
  • the needle is removed and the wire remains in place.
  • the wire is secured so it will not become dislodged.
  • the patient is transferred to the surgical suite, where she is prepared for the surgical biopsy. The surgeon uses the wire as a guide towards the area requiring biopsy.
  • a tissue sample is taken, corresponding with the amount of suspicious tissue seen on mammogram surrounding the needle tip. This excised tissue sample is mammogrammed after excision, and the film obtained from the specimen is compared with the original mammogram to confirm that the tissue area identified on the original mammogram has been adequately excised.
  • a surgical biopsy can be performed to remove a segment of tissue from a larger tissue mass that is abnormal-looking on mammography. The segment of tissue can then yield a diagnosis that then guides further therapy.
  • a surgical procedure can be performed that excises the entire abnormal area for definitive therapy. This procedure is termed a wide excision, because the abnormal area is excised widely, that is with a rim of normal tissue around it.
  • the term biopsy can be applied to a wide surgical excision. Wide surgical excisions are currently commonly performed using needle localization techniques as described above, so the surgeon can identify the area within the breast to be excised.
  • the term wide surgical excision, as used herein, includes what is commonly termed a lumpectomy.
  • Needle localization techniques have limitations. First, multiple positioning attempts and mammographic confirmations may be required. Second, when used as a preliminary procedure, the patient must usually be transported from the mammography suite to the operating suite, potentially increasing patient stress, time delay and procedure cost. Further, the surgical procedure cannot be carried out until the localization is complete, so if there is difficulty placing the localization wire, the surgical team and operating room remain in a state of readiness, wasting time and personnel resources. Third, there are inaccuracies that affect the accuracy of the J-wire in guiding the surgeon. For example, the wire may become dislodged, or its tip may not accurately reflect the best tissue area to be removed.
  • the present invention includes systems for placing a surgical instrument into a spatial relationship with a lesion.
  • the system may include a data translation system that translates a set of data points that identify the lesion in at least two two- dimensional planes into a set of three-dimensional coordinates that identify the position of the lesion in three-dimensional space.
  • the system may also include a tracking system that is related to the surgical instrument that generates tracking signals for identifying the position of the surgical instrument in three-dimensional space.
  • the system may also include a representation system that produces a representation of the positions of the surgical instrument and the lesion in three-dimensional space relative to each other, based on the signals generated by the tracking system and the set of three-dimensional coordinates produced by the data translation system, wherein the placement of the surgical instrument into spatial relationship with the lesion is guided by reference to the aforesaid representation.
  • the present invention includes a system for guiding the placement of a surgical instrument into spatial relationship with a lesion including a data translation system, a positioning system, a tracking system and a representation system.
  • the data translation system may translate a set of data points identifying the lesion in at least two two-dimensional planes into a set of three-dimensional coordinates that identify the lesion in three-dimensional space.
  • the positioning system may identify the position of the lesion in three-dimensional space relative to a three- dimensional position of at least one anatomic landmark.
  • the tracking system may be disposed in relation to the surgical instrument to generate tracking signals identifying the position of the surgical instrument in three dimensional space.
  • the representation system may produce at least one representation of the position of the surgical instrument in three-dimensional space related to the position of the lesion or the spatial landmark, so that the placement of the surgical instrument into spatial relationship with the lesion is guided by reference to the representation.
  • the invention includes a mammography system for orienting a breast to facilitate the biopsy of a breast lesion.
  • the mammography system includes a mammography device that may obtain mammograms in at least two different planes and that may obtain mammograms in a plurality of planes relative to a defined axis of the breast, a first set of mammograms that identify the position of the lesion within the breast, a first set of two-dimensional coordinates corresponding to the first set of mammograms, an adjustment system that generates a set of positional instructions that direct the positioning of the mammography device relative to the breast for obtaining a second set of mammograms that show the lesion centrally located on at least one film, and a compression system for securing the breast so that the position of the lesion within the breast corresponds to the position of the lesion located on the second set of mammograms.
  • the invention includes a method for obtaining a tissue sample from the breast.
  • This practice of the invention includes identifying the position of the target tissue on at least two mammograms, digitizing data correlated with the mammograms, determining the position of the target tissue in three dimensional space using the digitized data, providing a surgical instrument suitable for obtaining a sample of the target tissue, electronically tracking the position of the surgical instrument relative to the target tissue, creating a two-dimensional representation of the position of the surgical instrument, directing the surgical instrument to the target tissue by referring to the two-dimensional representation, and using the instrument to obtain a sample of the target tissue.
  • Figure 1 shows a schematic perspective view of an operator directing a surgical instrument towards an identified lesion in a breast in accordance with the systems and methods of the present invention.
  • Figure 2 shows a perspective view of an embodiment of a lesion tracking system applied to a patient.
  • Figures 3A-C show embodiments of components of a needle holder assembly.
  • Figure 4 shows an embodiment of a needle holder assembly held by an operator.
  • Figure 5 shows a schematic perspective view of an operator identifying anatomic landmarks in a compressed breast.
  • Figure 6 shows a schematic perspective view of an operator identifying anatomic landmarks in a free-form breast in a sterile setting.
  • Figure 7 provides a flow chart summarizing steps of a practice of the present invention.
  • the present invention provides improvements in the targeting of tissue areas for biopsies and related procedures.
  • the systems and methods of the present invention will be applied to the targeting of tissue areas within the breast.
  • biopsy includes the removal of a body tissue of any size or amount that includes the examination of its gross or microscopic; biopsies can be directed, for example, towards grossly identifiable tissues, microscopic tissues not visible to the naked eye, or individual cells that may be suspended in a body fluid.
  • biopsy would include those surgical procedures where tissues are removed for definitive therapy of an abnormality insofar as those procedures result in the removal of a body tissue that is grossly and/or microscopically examined.
  • biopsy further includes those diagnostic modalities involving contact with a tissue area to determine tissue abnormalities by employing techniques permitting tissue evaluation without tissue removal.
  • this type of biopsy can include the optical evaluation of the tissues, for example by fluorescence, the thermal evaluation of the tissue, electromagnetic evaluation of the tissue, the chemical evaluation of the tissue, the biochemical evaluation of the tissue or the immunological evaluation of the tissue.
  • This type of biopsy technique includes, without restriction, diagnostic modalities developed through the genetic or biotechnology arts that can be adapted for the local diagnosis of in vivo tissue abnormalities.
  • a surgical instrument can include any tool adapted for performing a biopsy.
  • a surgical instrument can include any device adapted for positioning a diagnostic modality into contact with or biological juxtaposition to an in vivo tissue to evaluate an abnormality of said tissue.
  • Examples of surgical instruments can include excisional devices such as needles or scalpels, as well as probes, catheters or other tools that can bear a biopsy device to a specified tissue area.
  • a surgical instrument further can include any tool adapted for treating or extirpating a lesion, including those tools or systems that can direct a therapeutic modality into proximity with a lesion.
  • a therapeutic modality may include any intervention that treats a pathological process.
  • a therapeutic modality may include chemotherapy or other drug therapy, phototherapy, radiotherapy or the application of electromagnetic energy to treat a pathological process.
  • a surgical instrument may refer to any tool adapted for directly or indirectly directing a therapeutic modality towards an area of pathology.
  • a surgical tool may directly impart therapy, as in a tool that provides for delivery of heat energy or other electromagnetic energy to an area of pathology.
  • a surgical tool may indirectly direct a therapeutic modality, for example, by positioning a drug delivery system, a radiotherapeutic implant or a source of electromagnetic energy in proximity to an area of pathology.
  • Other types of surgical tools that directly or indirectly treat pathological processes will be readily envisioned by those of ordinary skill in the art.
  • a spatial relationship with a lesion includes any position preselected by the operator as the desired location of the surgical instrument with respect to the lesion.
  • a spatial relationship can include the placement of a surgical tool at a preselected distance from the lesion so that the surgical tool can perform a wide excision thereof with a preselected amount of normal tissue surrounding the lesion.
  • a spatial relationship with a lesion can include placing a biopsy device in certain preselected positions with reference to the lesion so as to evaluate the health of the tissues in those locations.
  • a data translation system may include any device that translates a set of data points identifying the position of the lesion in at least two two-dimensional planes into a set of three-dimensional co-ordinates, wherein said set of three-dimensional coordinates identifies the position of the lesion in three- dimensional space.
  • Software can be provided to effect this translation.
  • the set of data points can be obtained from any source. These data points, for example, can be obtained from a prior or a concurrent digital mammogram. These data points, as another example, can be obtained by digitizing a set of film mammograms.
  • These data points can be obtained from any other system capable of evaluating the position of the lesion, such systems not being limited to mammography.
  • the data points can be obtained from ultrasonography of a breast, from MRI, from thermography or from any other system adapted for providing such information. Data points can also be derived from other modalities as appropriate for specific tissue areas.
  • a tracking system includes any device that is adapted for identifying the position of the surgical instrument being placed in spatial relationship to the lesion.
  • a tracking system may be disposed in a selected relation to the surgical instrument, generating tracking signals for identifying the position of the surgical instrument in three-dimensional space.
  • the tracking system includes a sensor affixed to the proximal end of the surgical instrument that permits tracking of the distal tip of the instrument, any other positional relationship can be constructed without departing with the scope of the invention disclosed herein.
  • a tracking system can include a positional probe affixed to the distal tip, or a sensor system surrounding the surgical instrument that relays signals regarding the three-dimensional position of the surgical instrument.
  • Other arrangements of a tracking system can be envisioned by those of ordinary skill in these arts without departing from the scope of the systems and methods of the present invention.
  • a representation system may include any system that produces a representation of the position of the surgical instrument and the position of lesion in three-dimensional space relative to each other.
  • This representation can take any form that conveys the desired information. For example, a three-dimensional holographic simulation can be formed. Alternatively, a set of two-dimensional images can be formed. A single two-dimensional image can be formed that uses additional indicia of three-dimensional relationality. Such indicia can include brightness, intensity, color, sound or any other indicia that can be devised by skilled artisans in this field.
  • a representation can convey information in a graphical or non-graphical form.
  • a representation can convey information as a set of data points to be received by a device adapted for the reception or processing of such data points. Since a plurality of representational forms can be envisioned by those of skill in the relevant arts, the scope of the claims below are not to be restricted to the specific embodiments disclosed herein.
  • an anatomic landmark may include any anatomic feature of the body.
  • An anatomic landmark may be identified as a feature existing within another anatomic structure.
  • An anatomic landmark can include an area of skin or bone.
  • an anatomic landmark can include a structure within the body such as a lymph node, a duct, a blood vessel or a cyst.
  • the anatomic landmark provides a landmark relative to which the positioning system can identify the position of the lesion.
  • the anatomic landmark may be securely fixed in a particular position, like a bone.
  • An anatomic landmark may be capable of mobility, like a cyst or a duct.
  • the positioning system disclosed herein is capable of determining the three dimensional position of the anatomic landmark at a particular point in time and correlating the position of the lesion thereto.
  • an introduction system may include any system for directing the surgical instrument in a selected direction relative to the selected tissue area.
  • An introduction system can include either human or non-human agents to direct the surgical instrument.
  • a machine or a robotic mechanism can direct the surgical instrument.
  • a human operator can direct the surgical instrument, or can direct the machine inserting the surgical instrument.
  • mammography system refers any mammography system familiar to practitioners of ordinary skill in the art.
  • the mammography system as the term is used in the present invention, comprises the features of the mammography system further disclosed as part of these systems and methods.
  • Such a mammography system includes a mammography device for obtaining mammograms in at least two different planes and capable of obtaining mammograms in a plurality of planes relative to a defined axis of a breast, a first set of mammograms, wherein said first set of mammograms identifies a position of the breast lesion within the breast, a first set of two-dimensional coordinates that corresponds to the first set of mammograms, an adjustment system that generates a set of positional instructions for the mammography device, wherein the set of positional instructions directs the positioning of the mammography device relative to the breast to obtain a second set of mammograms wherein the breast lesion is located centrally on at least one mammogram, and a compression system for securing the breast in relation to the mammography system so that the position of the lesion within the breast relative to the mammography system corresponds to the position of the lesion located on the second set of mammograms, thereby orienting the
  • the mammography system of the present invention can direct a mammography device for reorientation so that the target lesion is located in the center of a mammographic field. When compressed in that position, the lesion is amenable for biopsy. Lesions located in the center of a mammographic field can be easier to biopsy than lesions more peripherally located.
  • the systems and methods of the present invention permit biopsies to be taken from a plurality of approaches relative to the lesion.
  • the mammography system as described herein is interfaced with the other components of a system for obtaining a tissue sample from a selected area of the breast.
  • a tracking system is available for tracking the three dimensional position of a surgical instrument relative to the selected areas of the breast.
  • the position of the surgical instrument relative to the lesion can be identified in part by touching the tip of the surgical instrument to the skin at the location where the needle is to be inserted into the skin.
  • the positional representation system adjusts for the needle position relative to the lesion and creates a representation to guide the needle to the lesion even if the angle of needle insertion is varied from 90 degrees, and even if the direction of needle insertion relative to the breast is an atypical one.
  • the mammography system may be adapted for permitting biopsies to be taken from a plurality of angles.
  • FIG. 1 shows a representative embodiment of the systems and methods of the present invention.
  • a surgical instrument 212 may be inserted into a patient's breast 224 by an operator 210 in order to biopsy a lesion 234.
  • the lesion 234 is shown in this figure in a partial cut-away view of the breast 224, where the skin is schematically excised along the line 238, to reveal schematically the breast parenchyma 232 with the lesion 234 buried therein.
  • a surgical instrument 212 may include any surgical instrument, as discussed above.
  • the surgical instrument 212 may be a pre-localization needle that can be used to place a facilitate the placement of a J- wire or comparable device for needle localization.
  • the surgical instrument 212 bears at its distal end a needle holder assembly 214 that contains a position sensor (not shown) integrated with a tracking system (not shown) that tracks the position of the surgical instrument 212, here a needle.
  • the sensor on the needle holder assembly 214 is in electrical communication through a cable 218 that carries signals to the tracking system, described in more detail below.
  • the surgical instrument 212 is being directed towards a breast lesion 234 by the operator 210 who is able to view a representational image 242 on a user interface 240.
  • the patient's breast 224 in the illustrated embodiment is compressed between an upper compression plate 220 and a lower compression plate 222.
  • the angle by which the mammography apparatus is adjusted is represented at 226 as the angle between the craniocaudal angle plane 230 shown at b-b' and the selected plane 228 a-a' or the plane shown at a"-a'" which is parallel to the selected plane 228.
  • the systems and methods of the embodiment depicted in Figure 1 can use two dimensional mammographic views to obtain a three dimensional position of the lesion within the patient's breast, further providing mathematical corrections to compensate for the movement of the lesion due to mammographic compression, as well as to adjust for the parallax error introduced by the radial splaying of x-rays away from the vertical line.
  • An example of these methods is provided below as Example 1.
  • the systems and methods of the depicted embodiment further can provide three- dimensional information about the location of a surgical instrument 212.
  • Figure 1 shows displayed on a user interface 240 an image 242 of the relationship between the surgical instrument 212 and the lesion 234.
  • the image 242 depicted here includes a non- representational image 244 of the position of the surgical instrument and a non- representational image 248 of the position of the lesion.
  • the depicted embodiment provides a visual image that depicts the relationship of the image to the lesion as a two-dimensional image.
  • a visual image may be created that represents three-dimensionally the relationship of the instrument to the lesion, or it can produce a two dimensional image that simulates three dimensionality.
  • the representation system can depict a changing relationship of these structures in three-dimensional space, where the changing is depicted in real time.
  • the visual image produced can furthermore be representational or non- representational, where the term "representational" is understood to mean that the image attempts to display with pictorial accuracy the components it represents.
  • the visual image 242 shown in Figure 1 is a non-representational in that it presents symbols that stand for the relationship between the imaged components. Combinations of representational and nonrepresentational images can also be used together as part of a single or a plurality of visual images.
  • a representational image of a needle approaching the lesion would look like a needle as it approached an image that looked in some way "like" the breast lesion.
  • a non-representational visual image is understood to comprise the universe of abstractions in which a symbol or a set of symbols are used to convey the desired information about the proximity of the surgical instrument to the lesion. For example, a t symbol can be chosen to represent the needle, the lesion and their proximity.
  • the target symbol can symbolize proximity between the position of the surgical instrument and the position of the lesion, with the surgical instrument's position being shown as an image 244 moving relative to the image symbolizing the lesion 248.
  • horizontal and vertical lines can be drawn intersecting at their midpoints, with the surgical instrument's position showing up as a point on the screen being directed towards the point of intersection of the lines.
  • Such a set of symbols may indicate the position of the needle relative to the lesion in the craniocaudal and the mediolateral planes, while an additional symbol may be employed to demarcate the position of the needle in the anterior-posterior plane.
  • color changes can indicate anterior-posterior proximity to the lesion, or an additional graphic symbol, for example a thermometer symbol, can show the needle's closeness in this plane.
  • an additional graphic symbol for example a thermometer symbol
  • the visual representation can be an abstract one. It can be a single integrated view that provides information regarding the plane of the lesion as well as its depth.
  • the representation can be of a circle with a crosshair inside it.
  • the circle can be distinct from the crosshair, allowing the user to line up the needle precisely with the lesion before even penetrating the breast.
  • the user As the needle approaches the lesion, there can be a representation of concentric circles with the lesion at the center; according to this embodiment, the user must keep the circle and the crosshair aligned at all times while entering the breast and proceeding to the lesion.
  • the lesion can appear magnified as it is approached.
  • the color of the circle and crosshair can change when the needle has reached the center of the lesion.
  • FIG. 2 shows in more detail an embodiment of the present invention as applied to a patient's breast 2.
  • the patient's breast 2 (shown in dotted lines) is compressed in a mammography system between an upper mammogram plate 8 and a lower mammogram plate 4.
  • the breast 2 is shown to be compressed craniocaudally to prepare it for the insertion of a surgical instrument, here a needle 14.
  • the needle 14 is affixed to a detachable needle holder assembly 12 at its distal end. Included in the needle holder assembly 12 is a position sensor (not shown) that gathers signals related to the position of the needle.
  • the position sensor is integrated with the tracking system of the present invention, as described herein.
  • the position sensor is in electrical communication through a cable 20 with the fixed part 18 of the tracking system, shown here as related to the upper mammogram plate 8 and lower mammogram plate 4.
  • the fixed part 18 of the tracking system may be adjusted so that it can be affixed to both mammogram plates after the breast has been compressed between them. Other affixations also may be suitable, so that the fixed part 18 remains in a stable stationary relationship to the mammogram plates or to the compressed breast during the biopsy procedure.
  • a radio-opaque reference marker 24 is shown situated on the lower mammogram plate 4 to aid in the calibration and orientation of the tracking system.
  • the fixed part 18 of the tracking system is located at the lateral aspect of the mammogram plates, so that in this figure the fixed part 18 is situated lateral to the lateral aspect of the patient's compressed right breast.
  • This arrangement is for convenience only, and other arrangements may be set up to position the fixed part 18 that accommodate the needs of the operator.
  • a calibration cross 22 is integrated with the fixed part 18 of the tracking system to allow its calibration, as described in the present application.
  • the fixed part 18 of the tracking system also bears a platform 30 for holding the needle holder assembly 12 when it is not in active use directing a surgical instnce.
  • a cable 32 or set of cables may connect the fixed part 18 of the tracking system with the other components of the guidance system.
  • a transmitter may be attached to the fixed part 18 to transmit signals to the other components of the system.
  • the access window 10 is dimensionally adapted for permitting access to a breast lesion for biopsy while still maintaining compression of the breast in a preselected position.
  • the access window 10 may comprise a grid or a screen, or may contain a plurality of removable segments, or may comprise multiple insertion pores.
  • the access window 10 may be fabricated partially or entirely from a structurally stable material that is readily penetrable by the needle 14.
  • the access window 10 may be adapted for use on a single patient and may be disposable. Other configurations of the access window 10 may be known or devised with no more than routine experimentation by ordinary skilled practitioners.
  • Figures 3a, 3b and 3c show in more detail features of the system depicted in Figure 2.
  • Figure 3a shows a perspective view generally of a needle holder assembly 40 adapted for attachment to a needle using a saddle assembly 42 depicted generally in Figure 3b.
  • the needle holder assembly 40 is attached to the saddle assembly 42 through a coupler 44.
  • the attachment of the needle holder assembly 40 to the saddle assembly 42 is released through a disengagement mechanism 56.
  • the disengagement mechanism 56 is adapted for releasing the connection between the needle holder assembly 40 and the saddle assembly 42 so as to avoid transmitting force to the saddle assembly that might dislodge or move the needle after it is positioned.
  • a tracking sensor (not shown) can be included as part of the saddle assembly 42 or as part of the needle holder assembly 40. Signals from the tracking sensor are conveyed to the other components of the tracking system through a cable 50. The cable terminates in a male plug end 52 that can be inserted in a female socket 54.
  • An ejector mechanism 58 for example a mini-Bird ejector, triggers the release of the male plug end 52 from the female socket 54 in such a way as to minimize any force being transmitted through the needle holder assembly 40 to the needle (not shown).
  • a protective sheath 60 can be deployed over the plug end 52 within the socket 54 to cover the cable 50 and ensure its sterility.
  • Figure 3b shows generally perspective view of a saddle assembly 42 adapted for attachment to a biopsy needle, a prelocalization needle for needle localization or any surgical instnce (not shown).
  • a platform 62 can be seen providing a stable base for a needle hub or another similarly shaped surgical instmment.
  • a belt 64 is available to affix the needle firmly to the platform 62.
  • the belt 64 is locked by insertion into a locking slot 68.
  • a cradle 70 is shown adapted to hold the proximal end of the needle hub.
  • the saddle assembly 42 is connected with the needle holder assembly 40 of Figure 3a by way of a coupling end 48.
  • Figure 3c shows a perspective view of a calibration device 72 incorporated into a bed 74 for the needle holder assembly.
  • Figure 4 shows a perspective view of an embodiment of the needle holder assembly 100 as grasped by an operator's hand 102.
  • a grasping surface 104 provides a place where the needle holder assembly 100 can be manipulated by the operator.
  • a textured surface at the grasping surface 104 can indicate the precise location for grasping to optimize control.
  • a push button 108 can be available for releasing the saddle assembly 110 upon which is mounted a needle hub 112, here shown in continuity with a prelocalization needle apparatus
  • a coupler 124 is shown in continuity with the grasping surface 104. The coupler 124, when coupled to the coupling end 128 of the saddle assembly I 10, allows transmission of information regarding the position of the needle hub 112 and needle apparatus 114 to the remaining components of the tracking system.
  • Figure 5 shows an embodiment of the systems of the present invention, wherein an operator 153 uses an ultrasound apparatus 152 to identify set of anatomic landmarks 162 in a breast 154, here shown compressed between an upper mammographic plate 160 and a lower mammographic plate 158.
  • the ultrasound apparatus 152 is capable of being used through the upper mammographic plate 160.
  • the ultrasound apparatus 152 may also be used to identify a lesion 150. According to the systems and methods of the present invention, however, the lesion 150 need not be visible to the ultrasound apparatus 152. Rather, the position of the lesion 150 can be determined using the systems and methods as previously described.
  • FIG. 5 shows a schematic of a data map 156 being displayed on a user interface 151. As described previously, a variety of images can be formed to indicate the positional data of the data map 156. A representative illustration of a data map 156 is shown in this figure, but it is understood that alternate types and formats for data display may be readily envisioned by practitioners of ordinary skill in the relevant arts.
  • FIG. 6 shows an embodiment of the systems of the present invention as they may be used in the operating room.
  • an ultrasound apparatus 180 is employed by an operator 181 to identify a set of anatomic landmarks 182 in a breast 194 of a patient who is shown here covered with surgical drapes 198 undergoing a sterile procedure.
  • the ultrasound apparatus 180 may be provided to the operator 181 sterilely, or may be draped sterilely.
  • the cable 188 for the ultrasound apparatus 180 may be enclosed in a sterile covering as shown here.
  • the signals obtained from the ultrasound apparatus 180 may then be processed within the systems of the present invention.
  • These systems may refer to a data map (not shown) previously created by ultrasound, as described in Figure 5, to produce a graphic representation 190 that shows the position of the breast lesion in relation to the landmarks.
  • the graphic representation 190 of the three-dimensional position of the lesion relative to the landmarks may be produced even though the breast lesion 184 itself is not discernible by the ultrasound apparatus 180.
  • the graphic representation 190 is visible on a display monitor 192.
  • the graphic representation 190 obtained on the free-form unconfined and uncompressed breast 194 in the operating room may further be used to direct a surgical procedure that may be performed at the same time. After it has been captured and displayed, the graphic representation 190 may be used to guide a surgical instnce towards the lesion 184 in real time.
  • a periareolar incision 186 has been designed on the surface of the breast 194.
  • a surgical instmment (not shown) bearing a tracking system according to the present invention may be directed towards the lesion by reliance upon the graphic representation 190 and any subsequent graphic representation on the display 192 of the position of the surgical instmment relative to the lesion.
  • Systems and methods for directing a surgical instmment towards a lesion have been previously described and have been depicted in certain of the preceding figures.
  • a surgical instrument bearing a tracking system may be introduced sterilely onto the surgical field and it may be dimensionally calibrated so that its position is coordinated with the positional coordinates previously entered into the system via ultrasound relating the position of the anatomic landmarks to the position of the lesion.
  • the surgical instmment's position may be represented on the display screen by a preselected type of representation.
  • he position of the surgical instmment may appear on the display screen against a backdrop of the graphic representation 190 previously portrayed.
  • the graphic representation 190 may be altered or replaced by a different representation that indicates the position of the surgical instmment relative to the lesion.
  • the surgical instmment may be used for any diagnostic or therapeutic purpose.
  • the periareolar incision 186 may be used to provide the surgical instmment with access to the breast parenchyma.
  • the exti ⁇ ation of the lesion 184 may then be guided by the positional guidance that is provided to the surgeon by the representation systems of the present invention.
  • the combination of the tracking system, the representation system and the input from the ultrasound apparatus 180 in delineating the anatomic landmarks 182 according to the systems .and methods of the present invention permits a guided biopsy or a wide excision to be performed on a breast lesion 184 in a free-form non-compressed breast 194.
  • the systems and methods described herein permit the practice of a method for guiding the placement of a surgical instnce into a positional relationship with a lesion.
  • the position of the lesion in three-dimensional space can be determined and correlated with the position of an anatomic landmark.
  • the anatomic landmark will comprise a set of stmctures identified by a diagnostic modality, for example, ultrasound. Ultrasound can provide data regarding the position of an anatomic landmark through which a three dimensional position of the landmark can be determined. These positional data can be processed by the representation system to yield a map of the lesion's location with respect to the anatomic landmark. The biopsy procedure can then take place in a different setting.
  • Intraoperative ultrasound can be used to re-identify the relevant anatomic landmark relative to which the lesion's position has been mapped.
  • the tracking system can guide a surgical instmment towards the lesion by reference to the anatomic landmark the ultrasound identifies, locating the lesion even though there is no direct data produced during the procedure pertaining to the location of the lesion itself. Since the intraoperative ultrasound is being used only to identify the anatomic landmark and not to find the lesion, this method can be used to target a lesion that is itself invisible to ultrasound.
  • An analogous method would be employed to use other diagnostic modalities besides ultrasound that allow for the identification of an anatomic landmark relative to which the lesion can be positioned, even if the diagnostic modality itself cannot locate the lesion but can only identify the anatomic landmark.
  • the placement of the surgical instrument is guided towards a lesion by using ultrasound.
  • a lesion of the breast is to be biopsied.
  • the systems and methods of the present invention can be applied similarly to lesions in other locations, however, and should not be confined to the diagnosis and treatment of breast disorders.
  • these systems and methods can be used to biopsy a lesion of the axilla or of the inguinal area, for example a lymph node.
  • a lymph node for example a lymph node.
  • the location of the lesion in three- dimensional space is identified using a data translation system that produces from a set of two-dimensional coordinates a set of three-dimensional coordinates that correlate with the lesion's position.
  • a positioning system is then used to identify the position of at least one anatomic landmark.
  • the positioning system in this embodiment is an ultrasound system, capable of resolving the shape of small stmctures within the breast such as ductal stmctures, vascular stmctures or lymphatic stmctures.
  • the shape of a single stmcture or the architectural array of a plurality of stmctures comprises an anatomic landmark.
  • the tracking system identifies the positioning of the surgical instmment in space, as previously described.
  • the representation system can produce a representation indicating the position of the instmment relative to either the landmark or the lesion.
  • the representation can take place in real time.
  • a map that locates the position of the lesion relative to the anatomic landmark can be stored within the representation system so that the instrument can be directed towards the lesion by reference to the position of the instmment with respect to the anatomic landmark. Knowing the coordinates of the lesion with respect to the landmark allows these systems to calculate the position of the surgical instmment with respect to the lesion from data indicating the position of the surgical instnce with respect to the landmark.
  • data points may be derived from any modality capable of providing digital positional information, or any modality whose data output may be converted into digital positional information, for example by scanning.
  • Modalities that may provide such information include, but are not limited to, MRI, CT scan, PET scan, thermoscan, radionuclide scan and conventional X-rays.
  • Other modalities may be identified by skilled practitioners using current technologies or as technologies evolve to provide other mechanisms for obtaining positional data regarding the location of lesions or anatomic landmarks.
  • FIG. 7 shows a flow chart depicting the procedural steps of one practice of a method according to the present invention.
  • a needle can be placed as a needle localization for a subsequent biopsy. Similar procedural steps may be followed according to the method of the present invention to effect the positioning of a surgical instmment relative to a breast lesion.
  • the tracking system is calibrated by the technician. This can be effected by placing the transmitter block and sleeve of the tracking system on a radio-opaque crosshair and activating the calibration system of the tracking system. Calibration is automatically performed through the activation of a software-driven sequence.
  • data from the patient's screening mammograms are entered into the system.
  • the screening lateral film is placed on the screen of the data translation system.
  • the technician can use a stylus that is part of the data translation system to touch the lesion, then the left edge of the breast at the line that has appeared on the screen, followed by the right edge of the breast on the same line. Guidelines and instmctions for data input can be produced on the screen by appropriate software.
  • the technician places the screening craniocaudal mammogram. film on the screen and uses the stylus in the same manner.
  • the data translation device can interface with the mammography system to produce a set of instmctions for reorienting the mammography device.
  • a set of instmctions may be provided, comprising an angle and a direction (left or right) for placement of the mammography machine arm for the lateral mammographic film and for the craniocaudal. mammography film.
  • the sum of the two angles in this embodiment is about 90 degrees.
  • the arm of the machine can be rotated to achieve the appropriate angle for the lateral mammogram using this method.
  • a lateral mammogram is taken with the mammogram. device oriented in this position.
  • compression is released and the machine arm can be moved to the next appropriate angle, here determined to be 90 degrees minus the previous angle.
  • a different top plate with a hole and a grid can be used for this film.
  • the patient's breast may again be compressed after being placed on the mammography plate.
  • a craniocaudal film can be taken. Both films may be developed while the breast remains compressed in' the craniocaudal position.
  • data can be input into the data translation system from these two films.
  • the lateral film can be placed on the data translation system screen and the stylus can be used to touch the lesion, the left edge of the breast along the line and the right edge of the breast along the same line, all instmctions and guidelines being generated by the software within the data translation system.
  • the craniocaudal film data can be input in a similar manner.
  • data thus input can be processed by the representation system to generate an image of the three dimensional position of the lesion. This image can be seen on the user interface of the representation system.
  • the tracker system can be applied to the patient and the surgical instmment.
  • the technician may apply a sterile pad on the base plate and may apply a tracking sensor to the surgical instmment, for example a needle.
  • the technician may then hand the needle to the radiologist.
  • the radiologist uses the tracking system to target the lesion for approach with the needle.
  • the needle can be calibrated by touching it to the sterile pad. As the radiologist looks at the image with the needle and the lesion on the screen, she can position the needle so that the circle and cross hair on the screen are aligned. She then can enter the breast with the needle.
  • the needle can be oriented towards the lesion by a pattern of concentric circles.
  • a set of concentric circles can appear and disappear on the screen as the lesion is approached.
  • the radiologist can refer to these circles to guide the needle towards the lesions.
  • a dotted line may appear to guide the approach to the lesion.
  • the color of the pattern may change as an indicator.
  • the radiologist can then detach the tracking sensor from the needle, leaving the needle in the breast.
  • a confirmatory set of mammograms can be taken with the needle in place. First a craniocaudal film may be taken in the compressed position.
  • the compression plates can be released and reapplied at an angle for generating a lateral mammogram.
  • These films can be examined to determine the accuracy of placement. Further steps taken depend upon the decision at Step 11. If placement is satisfactory, the "yes" path at Step 11 can be followed and the needle can be secured in place. If placement is not satisfactory, the "no" path at Step II can be followed, and the procedure can return to Step 6, where the films obtained at Step 10 are used to provide the data for the data entry step of Step 6.
  • a Tower with the transmitter is affixed to the biopsy plate absolutely. This establishes 0,0,0 relative to the surgical biopsy tool.
  • Biopsy Plate Indicator locations (A, B, C, .... And 1,2,3 %) relative to Ref Indicator are known and absolute.

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Abstract

La présente invention concerne des systèmes et des procédés qui permettent de guider un instrument (212) chirurgical dans une relation spatiale présélectionnée avec une lésion (234), en particulier une lésion du sein. Dans un mode de réalisation exemplaire, le système de l'invention comprend : un système de traduction de données qui traduit un ensemble de points de données représentant la position de la lésion en un ensemble de coordonnées tridimensionnelles; un système de localisation qui localise la position d'un instrument chirurgical dans un espace tridimensionnel; et un système de représentation qui produit une représentation (242, 244) de la position de l'instrument chirurgical par rapport à la lésion. Les systèmes de l'invention sont associés à des procédés permettant d'effectuer la biopsie d'une lésion et d'enlever celle-ci par chirurgie.
EP00928767A 1999-05-03 2000-05-03 Systemes et procedes permettant de cibler une lesion du sein Withdrawn EP1180963A1 (fr)

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US13229699P 1999-05-03 1999-05-03
US132296P 1999-05-03
PCT/US2000/012022 WO2000065989A1 (fr) 1999-05-03 2000-05-03 Systemes et procedes permettant de cibler une lesion du sein

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AU2001217746A1 (en) * 1998-05-14 2002-05-27 Calypso Medical, Inc. Systems and methods for locating and defining a target location within a human body
FR2816822B1 (fr) 2000-11-23 2003-05-09 Ge Med Sys Global Tech Co Llc Procede et dispositif de galactographie en radiologie mammographique par soustraction
US9623208B2 (en) 2004-01-12 2017-04-18 Varian Medical Systems, Inc. Instruments with location markers and methods for tracking instruments through anatomical passageways
US10195464B2 (en) 2004-06-24 2019-02-05 Varian Medical Systems, Inc. Systems and methods for treating a lung of a patient using guided radiation therapy or surgery
EP1778357A2 (fr) 2004-07-23 2007-05-02 Calypso Medical Technologies, Inc. Systemes de radiotherapie integres et procedes de traitement d'une cible chez un patient
US8437449B2 (en) 2004-07-23 2013-05-07 Varian Medical Systems, Inc. Dynamic/adaptive treatment planning for radiation therapy
US9283053B2 (en) 2005-09-19 2016-03-15 Varian Medical Systems, Inc. Apparatus and methods for implanting objects, such as bronchoscopically implanting markers in the lung of patients
EP2293720B1 (fr) 2008-06-05 2021-02-24 Varian Medical Systems, Inc. Compensation de mouvements pour imagerie médicale et systèmes et procédés associés
CN103347454B (zh) 2010-10-01 2016-10-12 瓦里安医疗系统公司 用于递送植入物，例如在肺中经支气管镜植入标记物的递送导管和方法
US9919165B2 (en) 2014-05-07 2018-03-20 Varian Medical Systems, Inc. Systems and methods for fiducial to plan association
US10043284B2 (en) 2014-05-07 2018-08-07 Varian Medical Systems, Inc. Systems and methods for real-time tumor tracking
US20200000442A1 (en) * 2018-06-28 2020-01-02 General Electric Company System and method for selecting a patient position and an equipment configuration for a medical procedure

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