WO2016135595A1 - Indirect visualization-assisted apparatus and method for positioning medical instruments - Google Patents

Indirect visualization-assisted apparatus and method for positioning medical instruments Download PDF

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Publication number
WO2016135595A1
WO2016135595A1 PCT/IB2016/050878 IB2016050878W WO2016135595A1 WO 2016135595 A1 WO2016135595 A1 WO 2016135595A1 IB 2016050878 W IB2016050878 W IB 2016050878W WO 2016135595 A1 WO2016135595 A1 WO 2016135595A1
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WIPO (PCT)
Prior art keywords
target tissue
medical instrument
visualization device
target
visualization
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PCT/IB2016/050878
Other languages
French (fr)
Inventor
Gian Luigi Cola
Raffaele Di Sarno
Fabio ZATTONI
Andrea GUTTILLA
Original Assignee
Faber Industrie S.P.A.
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.)
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Publication date
Application filed by Faber Industrie S.P.A. filed Critical Faber Industrie S.P.A.
Priority to EP16718447.2A priority Critical patent/EP3261552A1/en
Publication of WO2016135595A1 publication Critical patent/WO2016135595A1/en

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    • 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
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0241—Pointed or sharp biopsy instruments for prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
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    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
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    • 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
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    • A61B2017/00119—Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
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    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
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    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
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    • A61B2017/3411—Needle locating or guiding means using mechanical guide means with a plurality of holes, e.g. holes in matrix arrangement
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    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
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    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Definitions

  • the present invention relates to the medical field of percutaneous devices and procedures, in particular to an apparatus and method for facilitating the guide of medical instruments with percutaneous access when using remote visualization techniques, such as ultrasound scanning or other visualization techniques.
  • Minimally invasive surgery is an alternative surgical technique in which the undesired tissue is removed or destroyed in situ without resorting to open surgery, but rather by means of a localized percutaneous access assisted by indirect or remote visualization systems, in particular ultrasound visualization, endoscopy, etc.
  • prostate cancer is a common type of cancer which can be diagnosed and monitored using minimally invasive percutaneous biopsy, and treated for example with a percutaneous cryosurgery technique in which the destruction of the tumor is accomplished by localized freezing (hypothermia).
  • the prostate biopsy is a procedure which consists in removing small fragments of the prostate gland using a biopsy needle, guided with the aid of a visualization of the prostate gland and of the needle itself by an ultrasound probe introduced into the patient's rectum.
  • the needle may reach the prostate from within the rectum (trans-rectal route) or from the outside through the skin of the perineum between the testicles and the anus (trans-perineal route).
  • the therapeutic treatments such as cryosurgery, localized radiation therapy or laser therapy, are carried out using similar access and visualization procedures.
  • the visual quality of the two-dimensional ultrasound scanning does not always show vital organs adjacent to the target tissue clearly enough, especially when they are positioned behind the target tissue.
  • DE4010573 and US6206832 describe needle guides mountable to an ultrasound scanning visualization device, wherein the guide comprises a flat plate with through openings arranged in a grid for guiding puncture needles in predetermined positions of the grid.
  • These known guides allow the needle or a medical instrument in general to be guided along the holes of the plate.
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and are sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
  • - visual signaling means which generate a visual signaling on said distal surface of the reference means as a function of the spatial relationship between the reference means and the selected target position to assist in the positioning of the medical instrument with respect to the target tissue through a selected opening of said inlet openings.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
  • the visual signalling of aiding information for positioning the medical instrument on the distal surface of the reference means helps the physician to associate the images produced by the indirect visualization device with the patient's position and with the position of the reference means. This saves time, increases accuracy, facilitates repeatability and reduces the risk of error of minimally invasive percutaneous surgery.
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction
  • a depth reference the distance or position of which with respect to the guide channels may be adjusted in the guide direction and fixatable so as to provide an insertion end-of-stroke position of the medical instrument in a selected channel of the guide channels.
  • the apparatus comprises:
  • - processing means which determine the end-of-stroke position of the medical instrument as a function of a geometric parameter of the medical instrument and of the spatial relationship between the reference means and the image of the target tissue
  • - depth adjusting means which adjust and fix the position of the depth reference as a function of the determined end-of-stroke position.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • an apparatus for positioning a medical instrument with respect to a target tissue comprises:
  • - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction
  • transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for the misalignment between the guide channel and the selected target position.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • an apparatus for positioning a medical instrument with respect to a target tissue employed in combination with an indirect or remote visualization device, comprises:
  • - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction
  • transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for said deviation.
  • the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect visualization device, and comprises the steps of:
  • - positioning reference means with respect to the indirect visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
  • the apparatus comprises:
  • the alignment errors of the guide channel with respect to the target positions may be eliminated, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to the apparatus between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions of the first surgery must be located (such as in prostate biopsies or in percutaneous treatments of prostate cancer).
  • figure 1 shows an apparatus for positioning a medical instrument according to the invention
  • figures 2, 3, 4 are perspective views of details of the apparatus in figure 1 .
  • figures 5 and 6 show further details of the apparatus according to embodiments
  • figure 7 shows position adapters for adjusting the position of reference means of the apparatus according to an embodiment
  • figure 8 shows a use of the apparatus in a percutaneous prostate biopsy procedure
  • figures 9 and 10 show screens on a display of the apparatus in a step of visualizing and mapping a target tissue in a transversal visualization plane (fig. 9) and in a longitudinal visualization plane (fig. 10)
  • figure 1 1 shows a screen generated by the apparatus in a step of generating a 3D wire-frame model of a target tissue
  • figure 12 shows a screen generated by the apparatus in a step of selecting a target position in the image of the target tissue, where the medical instrument is intended to be positioned,
  • figure 13 shows a screen generated by the apparatus in a step of inserting a biopsy needle guided by the apparatus in a target tissue
  • figure 14 shows a screen generated by the apparatus in a step of determining a deviation magnitude between the current position of the target tissue and a position thereof during a previous percutaneous surgery
  • figure 15 shows a screen generated by the apparatus in a step of adjusting the position of a reference plate for guiding a medical instrument.
  • an apparatus 1 for positioning a medical instrument 2, such as a biopsy needle, with respect to a target tissue 3 comprises a support structure 4, such as a carriage or frame which can rest on or be secured to a floor and preferably adjustable in height, or a light and portable support structure (figure 1).
  • the support structure 4 is adapted to be positioned and held in place with respect to a support structure for a patient, such as an operating table, a chair or a bed.
  • the support structure 4 itself may comprise a support structure for the patient.
  • Apparatus 1 further comprises a first seat or mounting portion 6 for mounting an indirect or remote visualization device 5, such as an ultrasound visualization device, in a predetermined position to the support structure 4, as well as a signal connection 7, such as an outlet, an electrical or optical cable or a wireless link, for a signal connection between the visualization device 5 and an electronic control unit 8 arranged in the support structure 4.
  • an indirect or remote visualization device 5 such as an ultrasound visualization device
  • a signal connection 7 such as an outlet, an electrical or optical cable or a wireless link
  • Apparatus 1 further comprises reference means 9 having a distal surface 10 (facing away from the patient), a proximal side 13 (facing towards the patient) and a plurality of guide channels 1 1 with inlet openings 12 in the distal surface 10.
  • the guide channels 1 1 are arranged in a predetermined manner and sized so as to allow the medical instrument 2, such as a biopsy needle, to pass therethrough in a guided manner (figures 5, 6).
  • the reference means 9 have a flat reference plate with said guide channels 11 being mutually equidistant in the form of a Cartesian grid 41.
  • the plurality of guide channels 1 1 passes through the reference plate 9 in a guide direction 14 orthogonal to a plane of the reference plate 9.
  • the Cartesian grid 41 formed by the inlet openings 12 may be provided with indexing 15 which facilitates the identification of a selected opening 31 and the positioning of the biopsy needle 2.
  • Indexing 15 may typically comprise alphanumeric markings on the distal surface 10 which indicate the rows and columns of the input inlet openings 12 forming the Cartesian grid 41.
  • the Cartesian grid 41 may be replaced by a polar coordinate grid.
  • Apparatus 1 comprises a second portion or mounting seat 16 for mounting the reference means 9 to the support structure 4 in a predetermined position with respect to the indirect visualization device 5 (figures 2, 3, 4).
  • Apparatus 1 may comprise means 18, 19 for moving and adjusting the position of the indirect visualization device 5 with respect to the support structure 4 and, therefore, with respect to the reference means 9.
  • apparatus 1 may comprise translation means 18 for displacing ecograph 5 along the longitudinal axis 17 and rotation means 19 for rotating ecograph 5 about the longitudinal axis 17.
  • the translation means 18 and rotation ; 19 means may comprise electrical translation motors 22 and rotation motors 23 driven by the control unit 8 as a function of manual positioning commands, such as by means of a translation driving member or knob 20 and a rotation driving member or knob 21 in signal connection with the control unit 8.
  • the electrical translation 22 and rotation 23 motors may be arranged so as to move the mounting portion 6 which holds the visualization device 5 along suitable translation guides 24 and rotation guides 25 of the support structure 4 (figures 2, 4).
  • Apparatus 1 further comprises means for detecting the translational and rotational position of ecograph 5 with respect to a predetermined reference position (rest position) thereof.
  • the position detection means may comprise linear 26 and angular 27 position sensors or processing means which determine the position of ecograph 5 in dependency of electrical control signals of the electrical motors 22, 23.
  • the control unit 8 may be configured to displace the visualization device 5 with pitches of a predetermined magnitude and to automatically acquire an image generated by the visualization device 5 for each displacement pitch which is obtained. [00103] Based on the linear and angular position signals of the visualization device 5 with respect to the support structure 4 and to the (known) position of the reference means 9 with respect to the support structure 2, as well as on the images acquired and associated with the respective positions of the visualization device 5, the control unit 8 calculates a spatial relationship between the reference means 9 and (the position to which relate) an image of the target tissue 3 generated by the visualization device 5.
  • control unit 8 can determine a combined or overlapped visualization of an image of the target tissue 3 and of the positions of the guide channels 1 1 of the reference means 9 (Cartesian grid 41 , figures 1 1 , 14) on a display 28 in signal connection with the control unit 8 and preferably (but not necessarily) mounted to the support structure 4.
  • reference means 9 Cartesian grid 41 , figures 1 1 , 14
  • apparatus 1 further comprises visual signaling means 29 which generate a visual signaling 32 on the distal surface 10 of the reference means 9 as a function of the calculated spatial relationship between (the anatomical position to which relate) the image of the target tissue 3 and the reference means 9.
  • the control unit 8 may be configured to allow and possibly prompt the user to select (for example via a keyboard or touch screen) a target position 30 in the image of the target tissue 3 generated by the visualization device 5, with respect to which or in which the medical instrument 2 must be arranged (such as an insertion position of a biopsy needle), and to determine a spatial relationship between the reference means 9 and the selected target position 30 (figure 12).
  • the visual signaling means 29 In dependency of the spatial relationship between the reference means 9 and the selected target position 30, the visual signaling means 29 generate a visual signaling 32 on the distal surface 10 which assists the physician in the positioning of the medical instrument 2 with respect to the selected target position 30, using a selected opening 31 of the inlet openings 12.
  • the visual signaling 32 on the distal surface 10 may comprise one or more of:
  • the visual signaling means 29 may comprise a projector, such as a laser projector, mounted to the support structure 4 and in signal connection with the electronic control unit 8 (figure 1 ).
  • the visual signaling 32 of helpful information on the distal surface 10 of the reference plate 9 prevents long and tedious searches of the correct guide channel 1 1 and reduces the risk of incorrect positioning of the medical instrument 2. Moreover, the visual signaling 32 directly on the reference means 9 helps the physician to associate the images- produced by the visualization device 5 with the patient's position and with the position of the reference means 9. This saves time, increases accuracy, facilitates repeatability and reduces the risk of error of minimally invasive percutaneous surgery.
  • apparatus 1 comprises a depth reference 33, the distance (or position) of which with respect to the guide channels 1 1 may be adjusted in the guide direction 14 and fixed so as to provide an insertion end-of-stroke position of the medical instrument 2 in a selected channel 31 of the guide channels 1 1 to assist in the positioning of the medical instrument 2 with respect to the target tissue 3 (figures 2, 8).
  • control unit 8 is configured to determine the end-of- stroke position of the medical instrument 2 in dependency of a geometric parameter of the medical instrument 2 (such as a distance between a tip and a counter-abutment surface 36 of a biopsy needle) and of the spatial relationship between the reference means 9 and the position to which the image of the target tissue 3 or the selected target position 30 refers.
  • the geometric parameter may be selected by the user according to the type of medical instrument used and it serves for determining with certainty the spatial relationship between the reference means 9 and a handling portion of the medical instrument 2 (such as the proximal tip of a biopsy needle).
  • the control unit 8 drives depth adjusting means 34 connected to the support structure 2 which adjust and/or fixate the position of the depth reference 33 as a function of the determined end-of-stroke position.
  • the depth reference 33 may comprise an abutment surface 35 adapted to engage a corresponding counter-abutment surface 36 of the medical instrument 2 in the end-of-stroke position.
  • the abutment surface 35 may be formed in a small frame connected to the support structure 4 in a distal position (physician's side) with respect to the reference means 9 and translatable in the guide direction 14 by an electric motor 37 controlled by the control unit 8.
  • the depth reference 33 may comprise an end-of- stroke indicator adapted to interact with a corresponding reference device of the medical instrument 2 so as to provide a visual or acoustic warning which signals when the medical instrument 2 is in the end-of-stroke position.
  • apparatus 1 assists the physician in positioning the medical instrument 2 along the guide direction which in the prior art was totally delegated to the physician's experience and skill. This greatly reduces the risk of positioning error and damage to anatomical structures arranged behind the target position 30.
  • the depth reference further reduces the time required for a precise positioning of the medical instrument 2 and facilitates the repetition of percutaneous surgery and the re-finding of the same target positions 30. This is particularly advantageous for monitoring prostate tumors by periodical percutaneous biopsy.
  • apparatus 1 comprises transversal adjusting means 38 which allow the position of the reference means 9 to be adjusted with respect to the visualization device 5 in a transversal direction, preferably in a plane orthogonal to the guide direction 14 so as to compensate for misalignments between the selected target position 30 and a corresponding selected guide channel 31.
  • the adjusting means 38 may comprise manual adjusting means or automatic adjusting means, such as motorized and driven by the control unit 8 as a function of a misalignment magnitude calculated by the control unit or which can be entered by the user.
  • the adjusting means 38 have two degrees of adjustment freedom, e.g. two translations along perpendicular axes or a translation and a rotation in the plane orthogonal to the guide direction 14.
  • apparatus 1 may comprise processing means, for example implemented by the control unit 8, which determine a misalignment magnitude between the target position 30 selected in the image of the target tissue 3 and at least one of the guide channels 1 1 .
  • the misalignment magnitude may comprise a distance vector, e.g. in Cartesian coordinates (offset x, offset y) or in polar coordinates (offset a, offset r) between the selected target position 30 and an orthogonal projection of a guide channel selected in the plane of the image of the target tissue 3.
  • the processing means may:
  • [00128]- determine a spatial relationship between the reference means 9 and the selected target position 30 as a function of the spatial relationship between the "initial position" of the reference means 9 and the “image acquisition position” of the visualization device 5 and of the coordinates of the selected target position 30 in the acquired image, and
  • the processing means may:
  • [0013 1 ] - determine a deviation magnitude between the spatial relationship between the reference means 9 in the "initial position” and the selected target position 30 and a reference spatial relationship (referred to a previous use of apparatus 1 with the same patient) between the reference means 9 in the "initial position” and the same target position 30 in a previously acquired reference image of the same target tissue 3.
  • apparatus 1 or the user may compensate for the calculated deviation using the above said adjustment of the position of the reference means 9 with respect to the visualization device 5 in at least two dimensions in a direction transversal to the guide direction 29.
  • a further compensation adjustment of the position of the depth reference 33 is possible and included, depending on a deviation value in guide direction 9.
  • Such further compensation adjustment may be carried manually or automatically by the adjusting means 34 and the control unit 8, as already described above.
  • apparatus 1 may comprise a plurality of position adapter 39 (figure 7) of different sizes corresponding to different misalignment or deviation values.
  • the position adapters 39 may be mounted with a certain mutual positioning between the reference means 9 and the visualization device 5 (or more precisely: between the reference plate 9 and the second mounting seat or portion 16 of the support structure 4) and they have unique identification means for each size.
  • Apparatus 1 further comprises selection means which select one of the position adapters 39 as a function of the determined deviation or misalignment magnitude, and indication means which indicate the selected position adapter 39 to the user.
  • the electronic control unit 8 may be configured to automatically select the most suitable position adapter 39 for the deviation compensation and to indicate the selected position adapter on display 28 or by the visual signaling means 29 (figures 14,
  • the alignment errors of the guide channel 1 1 with respect to the target positions 30 may be eliminate, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to apparatus 1 between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions 30 of the first surgery must be located again.
  • This accurate location of target position is crucial in prostate biopsies and in percutaneous treatments for prostate cancer.
  • apparatus 1 may comprise processing means, such as the control unit 8, adapted to calculate an error value, such as a distance or a vector of distances in a system of coordinates in two or three dimensions, between a target position 30 and a position actually reached a point/portion of interest of the medical instrument 2 (e.g. by the tip of a biopsy needle), for one or more target positions 30 selected or for all the target positions 30 with respect to which the medical instrument 2 is positioned.
  • processing means such as the control unit 8
  • an error value such as a distance or a vector of distances in a system of coordinates in two or three dimensions
  • the calculation of the error value may be made based on, and by automatic analysis of, the images acquired by the visualization system 5.
  • the calculation of the error value may further take account of:
  • [00142] the spatial relationship between the reference means 9 or a general reference system of apparatus 1 and the selected target position or positions 30, such as by carrying out a comparison or a vectorial subtraction between the position of the point of interest of the medical instrument 2 and the target position 30.
  • the calculation and/or a visualization, e.g. by means of a display 28, of the error value may be carried out in real time.
  • the processing means together with warning or signaling means such as visual and/or acoustic means, e.g. display 28 and/or a warning horn, provide a permanent warning of the achievement and/or non-achievement of the target position 30, taking into account a predetermined accuracy value (e.g. a maximum acceptable distance of 0.5 mm or 1 .0 mm), so as to provide the physician with continuous information as to whether he/she is already in the "green" zone, where the medical instrument may be operated, or if he/she is still in the "red zone" too far from the target position 30.
  • a predetermined accuracy value e.g. a maximum acceptable distance of 0.5 mm or 1 .0 mm
  • the error values also understood as accuracy values actually achieved, may be entered in a report, e.g. together with images or inserted in the images of the target tissue 3 and of the selected target positions 30.
  • Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
  • apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to compare (shape and/or position of) outer edges of the target tissue 3, such as a prostate, identified in images generated by the visualization means 5 with (shape and/or position of) outer edges of the same target tissue 3 identified in corresponding images previously acquired and stored, such as graphical model, vector graph, 3D wireframe model or other type of model of the target tissue 30.
  • processing means e.g. the control unit 8 adapted to compare (shape and/or position of) outer edges of the target tissue 3, such as a prostate, identified in images generated by the visualization means 5 with (shape and/or position of) outer edges of the same target tissue 3 identified in corresponding images previously acquired and stored, such as graphical model, vector graph, 3D wireframe model or other type of model of the target tissue 30.
  • the processing means are adapted to identify areas of the target tissue with an evidence of shape and/or volume change. In many clinical conditions, such as prostate cancer, these identified areas are of considerable interest in the examinations and in subsequent surgeries.
  • Such identified areas may be reported in a report, e.g. together with images or highlighted in the images of the target tissue 3, along with values of shape, size or volume change.
  • Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
  • the processing means may further be adapted to prepare and store in a memory, in particular a portable data medium, a collection of images of the target tissue 3 acquired in first acquisition planes (e.g. transversal planes) mutually spaced at predetermined pitches, and second acquisition planes (e.g. longitudinal planes) mutually spaced at predetermined pitches and transversal to the first acquisition planes.
  • a database of images (such as of the "dicom” type) is thus obtained, referred to a plurality of "slices" of the target tissue 3 similar to an MRI, but with the addition that the target tissue 3 is here shown both in transversal "slices" and in longitudinal "slices”.
  • apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to:
  • [00154]- generate a combined visualization of one or more images generated by the visualization system 5 and said additional data and/or images.
  • the current position of the medical instrument 2 may be displayed, such as on display 28, by means of an image of the medical instrument generated in real time by the visualization system 5 and overlap the image of the medical instrument 2 with the additional data or images of the target tissue 3, which could for example reveal some details or features of the tissue which are not easily visible in ultrasound scanning images but very useful to the physician when positioning the medical instrument 2.
  • apparatus 1 may comprise simulation means, e.g. the control unit 8, adapted to display, for predetermined positions of the visualization system 5, images of the target tissue 3 previously acquired by the visualization system in the same predetermined positions.
  • simulation means e.g. the control unit 8, adapted to display, for predetermined positions of the visualization system 5, images of the target tissue 3 previously acquired by the visualization system in the same predetermined positions.
  • the physician can simulate and carry out, through an analysis of the images of the previous surgery or examination, a pre-selection of target points 30 that he/she wants to reach in the subsequent examination or surgery, and experiment or verify by simulation without patient, positioning paths of the medical instrument 2 (such as a biopsy needle) and any critical issues of the target positions 30, particularly in the peripheral areas of the target tissue 3.
  • the medical instrument 2 such as a biopsy needle
  • apparatus 1 comprises a signal interface for connecting a remote user interface, such as a computer, which allows data and/or images stored in a memory of apparatus 1 to be accessed, which memory could be an internal memory or a remote or external memory, used by apparatus 1.
  • a remote user interface such as a computer
  • the 2D or 3D visualization of the target tissue e.g. a prostate gland, and of the corresponding target points of intervention or sampling is thus also enabled remotely for authorized medical staff, e.g. the anatomopathologist, who can directly associate the acquired images with the results of examinations on the collected tissues.
  • authorized medical staff e.g. the anatomopathologist
  • processing means e.g. the control unit 8, of apparatus 1 can generate a combined visualization, e.g. on display 28, of images of the target tissue 3 together with features identified by the examination of samples taken, e.g. histological examination results, of the target tissue 3 in the target positions 30.
  • processing means e.g. the control unit 8, of apparatus 1 can generate a combined visualization, e.g. on display 28, of images of the target tissue 3 together with features identified by the examination of samples taken, e.g. histological examination results, of the target tissue 3 in the target positions 30.
  • apparatus 1 After or before the apparatus-patient positioning, apparatus 1 is put into operation, using a start control, after which the control unit 8 with the aid of the touch screen 28 prompts for the input of identification data of the intervention (i.e. the physician's name, the patient's name, identification data and interfacing data of the ultrasound probe 5 used, etc.).
  • identification data of the intervention i.e. the physician's name, the patient's name, identification data and interfacing data of the ultrasound probe 5 used, etc.
  • Apparatus 1 then assists the physician in an initial step of mapping the patient's prostate (figures 9, 10), guided by the touch screen 28 controlled by the control unit 8, in which the translation means 18 position the ultrasound probe 5 from a rest position relatively far from the patient to a starting position close to the patient and in the vicinity or in alignment with the plane of the reference plate 9. From the starting position, any further movement of the ultrasound probe 5 requires a manual control of the physician using the translation 20 and rotation 21 control knobs.
  • the control unit 8 drives the translation 18 and rotation 19 means so that they move ecograph 5 by a single linear or rotational pitch of predetermined magnitude for each actuation of knobs 20, 21 , and acquires the corresponding transversal , ultrasound scanning image transmitted by ecograph 5 for each linear pitch and the corresponding longitudinal ultrasound scanning image transmitted by ecograph 5 for each angular pitch.
  • control unit 8 determines a three-dimensional model of the external profile of the prostate (initial mapping).
  • the control unit 8 via the touch screen 28 displays selected ultrasound scanning images acquired and prompts the physician to outline the prostate margins in said selected images using a contour line (figure 11). Using the set of contour lines confirmed by the physician, the control unit 8 calculates and possibly displays a 3D wire-frame model 40 of the patient's prostate and calculates the spatial relationship (relative vectorial position) between the 3D model of the prostate and the reference plate 9 in "initial position".
  • the mapping step is followed by a step of selecting one or more target positions 30 for carrying out the biopsies and then the biopsy itself.
  • the translation means 18 position the ultrasound probe 5 in a translational "image acquisition" position so that the longitudinal ultrasound transducer of the probe substantially covers the entire distal-proximal length of the prostatic tissue of interest (target tissue 3).
  • the control unit 8 By displaying on display 28 the transversal ultrasound scanning images acquired and longitudinal ultrasound scanning images generated in the current longitudinal visualization plane of the ecograph, the control unit 8 prompts the physician to select the target positions 30 (figure 12) and stores them in a database of a memory on board of apparatus 1 or of a remote memory.
  • the laser projector 29 projects a line indicative of the current longitudinal visualization plane of ecograph 5 on the distal surface 10 of the reference plate 9, which line allows the physician to associate the ultrasound scanning image shown on display 28 with the actual anatomical situation of the patient (figure 5).
  • the control unit 8 generates and displays on display 28 or through the laser projector 29 a unique indication of the guide channel 1 1 to be used to guide the biopsy needle 2 to the selected target position 30.
  • the laser projector 29 projects a light indication of the corresponding inlet opening 31 directly on the distal surface 10 of the reference plate 9, for example with a circle around the opening.
  • control unit 8 displays on display 28 the longitudinal ultrasound scanning image in the visualization plane which includes the target position 30 and in which the progress of the biopsy needle into the target tissue 3 may be seen (figure 13).
  • control unit 8 controls the depth adjusting means 34 to position the small frame with the abutment surface 35 in an end-of-stroke position for the biopsy needle 2 in which the tip of the biopsy needle 2 reaches the selected target position 30.
  • the scheduled biopsies may be carried out in sequence.
  • the control unit 8 determines a deviation magnitude between the position of the prostate during the current biopsy session and the first biopsy session. To this end, the control unit 8 determines the visualization on display 28 of ultrasound scanning images acquired during the second session (current session) in two visualization planes not parallel to each other, and precisely a transversal ultrasound scanning image and a longitudinal ultrasound scanning image, as well as the portions of the 3D wire-frame model 40 of the prostate generated in the first session (previous session) for the same "image acquisition" positions of ecograph 5, thus highlighting a deviation of the position of the 3D model with respect to the current anatomical situation (figure 14).
  • control unit 8 prompts the user to overlap the portions of the 3D wireframe model 40 of the prostate as precisely as possible on the ultrasound scanning images of the prostate displayed, in particular through a "displacement" of the wire-frame model 40 along three orthogonal axes, e.g. by means of special functions available on the touch screen 28 (figure 14).
  • control unit 8 quantitatively determines the deviation magnitude of the prostate position with respect to the initial position thereof, and selects and displays the unique identification code of the position adapter 39 on display 28 which is suitable for compensating for such a deviation (figure 15).
  • the user inserts the position adapter 39 suggested by apparatus 1 between the reference plate 9 and the second mounting portion 16 and fixates the connection between them, resulting in the adjustment of the position of the guide channels 1 1 in a direction transversal to the guide direction and a compensation of the patient positioning in the two dimensions of the plane of the reference plate 9.

Abstract

An apparatus (1) for positioning a medical instrument (2) with respect to a target tissue (3) comprises reference means (9) with a plurality of guide channels (11) to allow the medical instrument (2) to pass in a guided manner, processing means (8) which determine a misalignment magnitude between at least one of the guide channels (11) and a target position (30) in the target tissue (3), transversal adjusting means (38) which allow the position of the reference means (9) to be adjusted so as to compensate for the misalignment between the target position (30) and the guide channel (31).

Description

DESCRIPTION
"INDIRECT VISUALIZATION-ASSISTED APPARATUS AND METHOD FOR
POSITIONING MEDICAL INSTRUMENTS"
[0001] The present invention relates to the medical field of percutaneous devices and procedures, in particular to an apparatus and method for facilitating the guide of medical instruments with percutaneous access when using remote visualization techniques, such as ultrasound scanning or other visualization techniques.
[0002] One of the widespread practices of clinical surgery is the localized and targeted resection of body tissues aimed at removing undesirable tissues, such as lesions, and/or at taking tissue samples (biopsy) for histological examination.
[0003] The traditional surgical resection involves an incision in the patient's skin to directly expose the undesirable tissue for a visual and tactile examination thereof. While open surgery entails a remarkable trauma for the patient, in the past it was considered the preferred choice of surgeons for its effectiveness, the direct visibility and the related ease of being able to verify, during the resection, the exact position and the complete removal of the undesirable tissue.
[0004] Minimally invasive surgery is an alternative surgical technique in which the undesired tissue is removed or destroyed in situ without resorting to open surgery, but rather by means of a localized percutaneous access assisted by indirect or remote visualization systems, in particular ultrasound visualization, endoscopy, etc.
[0005] For example, prostate cancer is a common type of cancer which can be diagnosed and monitored using minimally invasive percutaneous biopsy, and treated for example with a percutaneous cryosurgery technique in which the destruction of the tumor is accomplished by localized freezing (hypothermia).
[0006] The prostate biopsy is a procedure which consists in removing small fragments of the prostate gland using a biopsy needle, guided with the aid of a visualization of the prostate gland and of the needle itself by an ultrasound probe introduced into the patient's rectum. The needle may reach the prostate from within the rectum (trans-rectal route) or from the outside through the skin of the perineum between the testicles and the anus (trans-perineal route).
[0007] The therapeutic treatments, such as cryosurgery, localized radiation therapy or laser therapy, are carried out using similar access and visualization procedures.
[0008] Other known surgical procedures which can be carried out in a minimally invasive percutaneous manner include hyperthermia, ablation by means of alcohol, radiation seed implantation, photodynamic therapy and brachytherapy.
[0009] In patients with localized prostate cancer, there are several therapeutic options: active surveillance, surgery or radiotherapy.
[0010] Active surveillance of the disease course involves a PSA monitoring program by blood test, digital exploration and additional biopsies at predetermined time intervals, aimed at promptly intervening but only in case of real invasive tumor progression. Obviously, minimally invasive procedures would be the preferable choice to limit the trauma and shorten the patient's postoperative course.
[001 1] However, in procedures without direct visibility, the physician must guess the depth of the needle position in the patient's body without being able to directly see the penetration depth, the position and size of the suspect lesion.
[0012] Moreover, in many situations, the visual quality of the two-dimensional ultrasound scanning does not always show vital organs adjacent to the target tissue clearly enough, especially when they are positioned behind the target tissue.
[0013] Therefore, the effective use of such instruments for these types of procedures requires a great experience and skill of the physician.
[0014] In the case of prostate biopsy or cryosurgical prostatectomy, the prostate being located close to the anal sphincter muscle, to. the colon, bladder and urethra, an inaccurate freezing or resection of a tumor in these regions may cause irreversible damage to these organs nearby, such as incontinence and impotence.
[0015] Therefore, the need is felt to reach the target positions identified for biopsy or for treatment with greater accuracy and certainty and to repeat the same operations in the points previously identified in order to verify the disease course and/or repeat the treatment.
[0016] DE4010573 and US6206832 describe needle guides mountable to an ultrasound scanning visualization device, wherein the guide comprises a flat plate with through openings arranged in a grid for guiding puncture needles in predetermined positions of the grid. These known guides allow the needle or a medical instrument in general to be guided along the holes of the plate. However, the solutions suggested in DE4010573 and US6206832 do not allow a sure positioning of the medical instrument in three dimensions and are subject to positioning errors due to use of a wrong hole of the guide plate, to the uncertainty of the needle penetration depth, to the counter-intuitive visualization of the anatomical situation and of the positioning of the puncture needle, as well as to the uncertainty of the patient's positioning with respect to the apparatus as well as to the uncertainty of the positioning of the anatomical structure in the patient's body. [0017] Therefore, it is object of the invention to provide an apparatus and method for positioning medical instruments in percutaneous procedures assisted by indirect visualization, e.g. ultrasound scanning, having such features as to obviate at least some of the drawbacks of the prior art.
[0018] These and other objects are achieved by an apparatus according to claim 1 and by a method according to claim 10. The dependent claims describe advantageous embodiments.
[0019] According to an aspect of the invention, an apparatus for positioning a medical instrument with respect to a target tissue, employed in combination with an indirect or remote visualization device, comprises:
[0020] - reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and are sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
[0021] - mounting means for mounting the reference means in a determined position with respect to the indirect visualization device which is suitable to generate an image of the target tissue,
[0022] - processing means which determine a spatial relationship between the reference means and an image of the target tissue generated by the indirect visualization device,
[0023] - visual signaling means which generate a visual signaling on said distal surface of the reference means as a function of the spatial relationship between the reference means and the selected target position to assist in the positioning of the medical instrument with respect to the target tissue through a selected opening of said inlet openings.
[0024] Likewise, the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
[0025] - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a distal surface and a plurality of guide channels with inlet openings in the distal surface, wherein the guide channels are arranged in a predetermined manner and sized so as to allow the medical instrument to pass through said guide channels in a guided manner,
[0026] - determining a spatial relationship between the reference means and the indirect visualization device,
[0027] - obtaining an image of the target tissue by means of the indirect visualization device, [0028] - selecting, in the obtained image of the target tissue, a target position with respect to which the medical instrument must be arranged;
[0029] - determining a spatial relationship between the reference means and the selected target position,
[0030] - as a function of the spatial relationship between the reference means and the selected target position, generating a visual signaling on said distal surface to assist in the positioning of the medical instrument with respect to the selected target position through a selected opening of said inlet openings.
[0031] Due to the visual signalling of aiding information for positioning the medical instrument on the distal surface of the reference means, long and tedious searches of the correct guide channel are prevented and the risk of incorrect positioning of the medical instrument is reduced. Moreover, the visual signaling on the reference means helps the physician to associate the images produced by the indirect visualization device with the patient's position and with the position of the reference means. This saves time, increases accuracy, facilitates repeatability and reduces the risk of error of minimally invasive percutaneous surgery.
[0032] According to a further aspect of the invention, an apparatus for positioning a medical instrument with respect to a target tissue, employed in combination with an indirect or remote visualization device, comprises:
[0033] - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0034] - mounting means for mounting the reference means in a determined position with respect to the indirect visualization device which is adapted to generate an image of the target tissue,
[0035] - processing means which determine a spatial relationship between the reference means and an image of the target tissue generated by the indirect visualization device,
[0036] - a depth reference, the distance or position of which with respect to the guide channels may be adjusted in the guide direction and fixatable so as to provide an insertion end-of-stroke position of the medical instrument in a selected channel of the guide channels.
[0037] According to an aspect of the invention, the apparatus comprises:
[0038] - processing means which determine the end-of-stroke position of the medical instrument as a function of a geometric parameter of the medical instrument and of the spatial relationship between the reference means and the image of the target tissue, [0039] - depth adjusting means which adjust and fix the position of the depth reference as a function of the determined end-of-stroke position.
[0040] Likewise, the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
[0041] - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0042] - positioning a depth reference with respect to the guide channels so as to provide an insertion end-of-stroke position of the medical instrument in a selected channel of the guide channels,
[0043] - determining a spatial relationship between the reference means and the indirect visualization device,
[0044] - obtaining an image of the target tissue by means of the indirect visualization device, [0045] - selecting, in the obtained image of the target tissue, a target position with respect to which the medical instrument must be arranged;
[0046] - determining a spatial relationship between the reference means and the selected target position,
[0047] - determining the end-of-stroke position of the medical instrument as a function of a geometric parameter of the medical instrument and of the spatial relationship between the reference means and the selected target position,
[0048] - adjusting and fixating the position of the depth reference in the guide direction as a function of the determined end-of-stroke position, to assist in the positioning of the medical instrument with respect to the selected target position.
[0049] Due to the depth reference and to its positioning which can be adjusted as a function of the selected target position, the apparatus assists the physician in positioning the medical instrument in the third dimension (the insertion dimension) which in the prior art was totally delegated to the physician's experience and skill. This greatly reduces the risk of positioning error and damage to anatomical structures arranged behind the target position. The depth reference further reduces the time required for a precise positioning of the medical instrument and facilitates a repetition of percutaneous surgery and the re-finding of the same target positions. [0050] According to a still further aspect of the invention, an apparatus for positioning a medical instrument with respect to a target tissue, employed in combination with an indirect or remote visualization device, comprises:
[0051] - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0052] - mounting means for mounting the reference means in a determined position with respect to the indirect visualization device which is suitable to generate an image of the target tissue,
[0053] - processing means which determine:
- a spatial relationship between the reference means and an image of the target tissue generated by the indirect visualization device,
- a misalignment magnitude between at least one of the guide channels and a target position selected in the image of the target tissue,
[0054] - transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for the misalignment between the guide channel and the selected target position.
[0055] Likewise, the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect or remote visualization device, and comprises the steps of:
[0056] - positioning reference means with respect to the indirect or remote visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0057] - determining a spatial relationship between the reference means and the indirect visualization device,
[0058] - obtaining an image of the target tissue by means of the indirect visualization device, [0059] - selecting, in the obtained image of the target tissue, a target position with respect to which the medical instrument must be arranged;
[0060] - determining a spatial relationship between the reference means and the selected target position,
[0061] - determining a misalignment magnitude between the selected target position and at least one of the guide channels,
[0062] - adjusting the position of the reference means with respect to the visualization device in a direction transversal to the guide direction so as to compensate for the misalignment between the selected target position and the guide channel.
[0063] According to a still further aspect of the invention, an apparatus for positioning a medical instrument with respect to a target tissue, employed in combination with an indirect or remote visualization device, comprises:
[0064] - reference means having guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0065] - mounting means for mounting the reference means in a determined position with respect to the indirect visualization device which is suitable to generate an image of the target tissue,
[0066] - processing means which determine:
- a spatial relationship between the reference means and an image of the target tissue generated by the indirect visualization device,
- a spatial relationship between the reference means and a selected target position in the generated image of the target tissue,
- a deviation magnitude between the spatial relationship between the reference means and the selected target position, and a reference spatial relationship between the reference means and the same target position in a previously acquired reference image of the same target tissue,
[0067] - transversal adjusting means which allow the position of the reference means to be adjusted with respect to the visualization device in a direction transversal to the guide direction, so as to compensate for said deviation.
[0068] Likewise, the invention provides a method for positioning a medical instrument with respect to a target tissue, said method being employed in combination with an indirect visualization device, and comprises the steps of:
[0069] - positioning reference means with respect to the indirect visualization device in a region which is near but external to a patient, which facilitates the access to the target tissue, said reference means having a plurality of guide channels arranged in a predetermined manner and sized so as to allow the medical instrument to pass in a guided manner through said guide channels in a guide direction,
[0070] - determining a spatial relationship between the reference means and the indirect visualization device,
[0071] - obtaining an image of the target tissue by means of the indirect visualization device, [0072] - selecting, in the obtained image of the target tissue, a target position with respect to which the medical instrument must be arranged;
[0073] - determining a spatial relationship between the reference means and the selected target position,
[0074] - determining a deviation magnitude between the spatial relationship between the reference means and the selected target position, and a reference spatial relationship between the reference means and the same target position in a previously acquired reference image of the same target tissue,
[0075] - compensating for said deviation by adjusting the position of the reference means with respect to the visualization device in a direction transversal to the guide direction.
[0076] According to an aspect of the invention, the apparatus comprises:
[0077] - a plurality of position adapters of different sizes, mountable between the reference means and the visualization device, said position adapters having unique identification means for each size,
[0078] - selecting means which select one of the position adapters as a function of the determined deviation magnitude,
[0079] - indication means which indicate the selected position adapter to the user.
[0080] Thereby, the alignment errors of the guide channel with respect to the target positions may be eliminated, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to the apparatus between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions of the first surgery must be located (such as in prostate biopsies or in percutaneous treatments of prostate cancer).
[0081] In order to better understand the invention and appreciate the benefits thereof, some exemplary non-limiting embodiments thereof are described hereinafter with reference to the accompanying drawings, in which:
[0082] figure 1 shows an apparatus for positioning a medical instrument according to the invention,
[0083] figures 2, 3, 4 are perspective views of details of the apparatus in figure 1 ,
[0084] figures 5 and 6 show further details of the apparatus according to embodiments, [0085] figure 7 shows position adapters for adjusting the position of reference means of the apparatus according to an embodiment, [0086] figure 8 shows a use of the apparatus in a percutaneous prostate biopsy procedure, [0087] figures 9 and 10 show screens on a display of the apparatus in a step of visualizing and mapping a target tissue in a transversal visualization plane (fig. 9) and in a longitudinal visualization plane (fig. 10),
[0088] figure 1 1 shows a screen generated by the apparatus in a step of generating a 3D wire-frame model of a target tissue,
[0089] figure 12 shows a screen generated by the apparatus in a step of selecting a target position in the image of the target tissue, where the medical instrument is intended to be positioned,
[0090] figure 13 shows a screen generated by the apparatus in a step of inserting a biopsy needle guided by the apparatus in a target tissue,
[0091] figure 14 shows a screen generated by the apparatus in a step of determining a deviation magnitude between the current position of the target tissue and a position thereof during a previous percutaneous surgery,
[0092] figure 15 shows a screen generated by the apparatus in a step of adjusting the position of a reference plate for guiding a medical instrument.
[0093] With reference to the figures, an apparatus 1 for positioning a medical instrument 2, such as a biopsy needle, with respect to a target tissue 3 comprises a support structure 4, such as a carriage or frame which can rest on or be secured to a floor and preferably adjustable in height, or a light and portable support structure (figure 1). The support structure 4 is adapted to be positioned and held in place with respect to a support structure for a patient, such as an operating table, a chair or a bed. Alternatively, the support structure 4 itself may comprise a support structure for the patient.
[0094] Apparatus 1 further comprises a first seat or mounting portion 6 for mounting an indirect or remote visualization device 5, such as an ultrasound visualization device, in a predetermined position to the support structure 4, as well as a signal connection 7, such as an outlet, an electrical or optical cable or a wireless link, for a signal connection between the visualization device 5 and an electronic control unit 8 arranged in the support structure 4.
[0095] Apparatus 1 further comprises reference means 9 having a distal surface 10 (facing away from the patient), a proximal side 13 (facing towards the patient) and a plurality of guide channels 1 1 with inlet openings 12 in the distal surface 10. The guide channels 1 1 are arranged in a predetermined manner and sized so as to allow the medical instrument 2, such as a biopsy needle, to pass therethrough in a guided manner (figures 5, 6).
[0096] In the embodiment shown, the reference means 9 have a flat reference plate with said guide channels 11 being mutually equidistant in the form of a Cartesian grid 41. The plurality of guide channels 1 1 passes through the reference plate 9 in a guide direction 14 orthogonal to a plane of the reference plate 9.
[0097] The Cartesian grid 41 formed by the inlet openings 12 may be provided with indexing 15 which facilitates the identification of a selected opening 31 and the positioning of the biopsy needle 2. Indexing 15 may typically comprise alphanumeric markings on the distal surface 10 which indicate the rows and columns of the input inlet openings 12 forming the Cartesian grid 41. The Cartesian grid 41 may be replaced by a polar coordinate grid.
[0098] Apparatus 1 comprises a second portion or mounting seat 16 for mounting the reference means 9 to the support structure 4 in a predetermined position with respect to the indirect visualization device 5 (figures 2, 3, 4).
[0099] Apparatus 1 may comprise means 18, 19 for moving and adjusting the position of the indirect visualization device 5 with respect to the support structure 4 and, therefore, with respect to the reference means 9. In the example of a rectal ecograph (or prostascope) of elongated shape along a longitudinal axis 17 with an ultrasound transducer in a longitudinal visualization plane radial to the longitudinal axis 17 and an ultrasound transducer in a visualization plane orthogonal to the longitudinal axis 17, apparatus 1 may comprise translation means 18 for displacing ecograph 5 along the longitudinal axis 17 and rotation means 19 for rotating ecograph 5 about the longitudinal axis 17.
[00100] The translation means 18 and rotation ;19 means may comprise electrical translation motors 22 and rotation motors 23 driven by the control unit 8 as a function of manual positioning commands, such as by means of a translation driving member or knob 20 and a rotation driving member or knob 21 in signal connection with the control unit 8. The electrical translation 22 and rotation 23 motors may be arranged so as to move the mounting portion 6 which holds the visualization device 5 along suitable translation guides 24 and rotation guides 25 of the support structure 4 (figures 2, 4).
[00101] Apparatus 1 further comprises means for detecting the translational and rotational position of ecograph 5 with respect to a predetermined reference position (rest position) thereof. The position detection means may comprise linear 26 and angular 27 position sensors or processing means which determine the position of ecograph 5 in dependency of electrical control signals of the electrical motors 22, 23.
[00102] The control unit 8 may be configured to displace the visualization device 5 with pitches of a predetermined magnitude and to automatically acquire an image generated by the visualization device 5 for each displacement pitch which is obtained. [00103] Based on the linear and angular position signals of the visualization device 5 with respect to the support structure 4 and to the (known) position of the reference means 9 with respect to the support structure 2, as well as on the images acquired and associated with the respective positions of the visualization device 5, the control unit 8 calculates a spatial relationship between the reference means 9 and (the position to which relate) an image of the target tissue 3 generated by the visualization device 5.
[00104] Using this spatial relationship, the control unit 8 can determine a combined or overlapped visualization of an image of the target tissue 3 and of the positions of the guide channels 1 1 of the reference means 9 (Cartesian grid 41 , figures 1 1 , 14) on a display 28 in signal connection with the control unit 8 and preferably (but not necessarily) mounted to the support structure 4.
[00105] According to an aspect of the invention (figures 1 , 5, 6), apparatus 1 further comprises visual signaling means 29 which generate a visual signaling 32 on the distal surface 10 of the reference means 9 as a function of the calculated spatial relationship between (the anatomical position to which relate) the image of the target tissue 3 and the reference means 9.
[00106]The control unit 8 may be configured to allow and possibly prompt the user to select (for example via a keyboard or touch screen) a target position 30 in the image of the target tissue 3 generated by the visualization device 5, with respect to which or in which the medical instrument 2 must be arranged (such as an insertion position of a biopsy needle), and to determine a spatial relationship between the reference means 9 and the selected target position 30 (figure 12).
[00107] In dependency of the spatial relationship between the reference means 9 and the selected target position 30, the visual signaling means 29 generate a visual signaling 32 on the distal surface 10 which assists the physician in the positioning of the medical instrument 2 with respect to the selected target position 30, using a selected opening 31 of the inlet openings 12.
[00108]According to embodiments (figures 5, 6), the visual signaling 32 on the distal surface 10 may comprise one or more of:
[00109]- an indication of the position of a visualization plane of the visualization device 5 containing the target tissue 3 or the target position 30,
[00110] - an indication of the position of a current image plane of the visualization device, [0011 1]- an indication or illumination of the selected inlet opening 31 ,
[00112]- an image representing the target tissue 3 or the target position 30, [001 13]- an image of the target tissue 3 in a current visualization plane of the visualization device 5,
for example by a laser or light projection on the distal surface 10.
[00114]The visual signaling means 29 may comprise a projector, such as a laser projector, mounted to the support structure 4 and in signal connection with the electronic control unit 8 (figure 1 ).
[00115]The visual signaling 32 of helpful information on the distal surface 10 of the reference plate 9 prevents long and tedious searches of the correct guide channel 1 1 and reduces the risk of incorrect positioning of the medical instrument 2. Moreover, the visual signaling 32 directly on the reference means 9 helps the physician to associate the images- produced by the visualization device 5 with the patient's position and with the position of the reference means 9. This saves time, increases accuracy, facilitates repeatability and reduces the risk of error of minimally invasive percutaneous surgery.
[00116] According to a further aspect of the invention, apparatus 1 comprises a depth reference 33, the distance (or position) of which with respect to the guide channels 1 1 may be adjusted in the guide direction 14 and fixed so as to provide an insertion end-of-stroke position of the medical instrument 2 in a selected channel 31 of the guide channels 1 1 to assist in the positioning of the medical instrument 2 with respect to the target tissue 3 (figures 2, 8).
[00117] According to an embodiment, the control unit 8 is configured to determine the end-of- stroke position of the medical instrument 2 in dependency of a geometric parameter of the medical instrument 2 (such as a distance between a tip and a counter-abutment surface 36 of a biopsy needle) and of the spatial relationship between the reference means 9 and the position to which the image of the target tissue 3 or the selected target position 30 refers. The geometric parameter may be selected by the user according to the type of medical instrument used and it serves for determining with certainty the spatial relationship between the reference means 9 and a handling portion of the medical instrument 2 (such as the proximal tip of a biopsy needle).
[001 18] The control unit 8 drives depth adjusting means 34 connected to the support structure 2 which adjust and/or fixate the position of the depth reference 33 as a function of the determined end-of-stroke position.
[00119] According to an embodiment, the depth reference 33 may comprise an abutment surface 35 adapted to engage a corresponding counter-abutment surface 36 of the medical instrument 2 in the end-of-stroke position. The abutment surface 35 may be formed in a small frame connected to the support structure 4 in a distal position (physician's side) with respect to the reference means 9 and translatable in the guide direction 14 by an electric motor 37 controlled by the control unit 8.
[00120]According to a further embodiment, the depth reference 33 may comprise an end-of- stroke indicator adapted to interact with a corresponding reference device of the medical instrument 2 so as to provide a visual or acoustic warning which signals when the medical instrument 2 is in the end-of-stroke position.
[00121] Due to the depth reference 33 and to its positioning which is adjustable as a function of the selected targeted position, apparatus 1 assists the physician in positioning the medical instrument 2 along the guide direction which in the prior art was totally delegated to the physician's experience and skill. This greatly reduces the risk of positioning error and damage to anatomical structures arranged behind the target position 30. The depth reference further reduces the time required for a precise positioning of the medical instrument 2 and facilitates the repetition of percutaneous surgery and the re-finding of the same target positions 30. This is particularly advantageous for monitoring prostate tumors by periodical percutaneous biopsy.
[00122] According to a further aspect of the invention, apparatus 1 comprises transversal adjusting means 38 which allow the position of the reference means 9 to be adjusted with respect to the visualization device 5 in a transversal direction, preferably in a plane orthogonal to the guide direction 14 so as to compensate for misalignments between the selected target position 30 and a corresponding selected guide channel 31.
[00123] The adjusting means 38 may comprise manual adjusting means or automatic adjusting means, such as motorized and driven by the control unit 8 as a function of a misalignment magnitude calculated by the control unit or which can be entered by the user. Preferably, the adjusting means 38 have two degrees of adjustment freedom, e.g. two translations along perpendicular axes or a translation and a rotation in the plane orthogonal to the guide direction 14.
[00124] In order to determine the possible misalignment, apparatus 1 may comprise processing means, for example implemented by the control unit 8, which determine a misalignment magnitude between the target position 30 selected in the image of the target tissue 3 and at least one of the guide channels 1 1 . For example, the misalignment magnitude may comprise a distance vector, e.g. in Cartesian coordinates (offset x, offset y) or in polar coordinates (offset a, offset r) between the selected target position 30 and an orthogonal projection of a guide channel selected in the plane of the image of the target tissue 3. [00125] To this end, the processing means may:
[00126] - determine a spatial relationship between the reference means 9, in particular the guide channels 1 1 , in an "initial position" thereof (i.e., a position which is not adjusted) and the visualization device 5 in an "image acquisition" position thereof (i.e., a position in which the acquisition of the image of the target tissue 3 takes place),
[00127] - select or prompt the user to select, in the acquired image of the target tissue 3, the target position 30 with respect to which or in which the medical instrument 2 must be arranged;
[00128]- determine a spatial relationship between the reference means 9 and the selected target position 30 as a function of the spatial relationship between the "initial position" of the reference means 9 and the "image acquisition position" of the visualization device 5 and of the coordinates of the selected target position 30 in the acquired image, and
[00129]- depending on the spatial relationship between the reference means 9 and the selected target position 30, determine the misalignment magnitude between the selected target position 30 and a selected guide channel 31 .
[00130] Alternatively or in addition, the processing means may:
[0013 1 ] - determine a deviation magnitude between the spatial relationship between the reference means 9 in the "initial position" and the selected target position 30 and a reference spatial relationship (referred to a previous use of apparatus 1 with the same patient) between the reference means 9 in the "initial position" and the same target position 30 in a previously acquired reference image of the same target tissue 3.
[00132]Also in this case, apparatus 1 or the user may compensate for the calculated deviation using the above said adjustment of the position of the reference means 9 with respect to the visualization device 5 in at least two dimensions in a direction transversal to the guide direction 29.
[00133] In order to compensate for the deviation of the target anatomical structure in three dimensions, a further compensation adjustment of the position of the depth reference 33 is possible and included, depending on a deviation value in guide direction 9. Such further compensation adjustment may be carried manually or automatically by the adjusting means 34 and the control unit 8, as already described above.
[00134] For a manual adjustment of the position of the reference means 9, apparatus 1 may comprise a plurality of position adapter 39 (figure 7) of different sizes corresponding to different misalignment or deviation values. The position adapters 39 may be mounted with a certain mutual positioning between the reference means 9 and the visualization device 5 (or more precisely: between the reference plate 9 and the second mounting seat or portion 16 of the support structure 4) and they have unique identification means for each size.
[00135] Apparatus 1 further comprises selection means which select one of the position adapters 39 as a function of the determined deviation or misalignment magnitude, and indication means which indicate the selected position adapter 39 to the user.
[00136] In an embodiment, the electronic control unit 8 may be configured to automatically select the most suitable position adapter 39 for the deviation compensation and to indicate the selected position adapter on display 28 or by the visual signaling means 29 (figures 14,
15).
[00137] Thereby, the alignment errors of the guide channel 1 1 with respect to the target positions 30 may be eliminate, which errors are due to differences in the patient's positioning and/or his/her anatomical structures with respect to apparatus 1 between a first percutaneous surgery and subsequent percutaneous surgeries in which exactly the same target positions 30 of the first surgery must be located again. This accurate location of target position is crucial in prostate biopsies and in percutaneous treatments for prostate cancer.
[00138] According to an embodiment, apparatus 1 may comprise processing means, such as the control unit 8, adapted to calculate an error value, such as a distance or a vector of distances in a system of coordinates in two or three dimensions, between a target position 30 and a position actually reached a point/portion of interest of the medical instrument 2 (e.g. by the tip of a biopsy needle), for one or more target positions 30 selected or for all the target positions 30 with respect to which the medical instrument 2 is positioned.
[00139] The calculation of the error value may be made based on, and by automatic analysis of, the images acquired by the visualization system 5.
[00140] The calculation of the error value may further take account of:
[00141] - the spatial relationship between the reference means 9 or a general reference system of apparatus 1 and the position of a point of interest of the medical instrument 2 identified in the acquired images, and
[00142] - the spatial relationship between the reference means 9 or a general reference system of apparatus 1 and the selected target position or positions 30, such as by carrying out a comparison or a vectorial subtraction between the position of the point of interest of the medical instrument 2 and the target position 30.
[00143] The calculation and/or a visualization, e.g. by means of a display 28, of the error value may be carried out in real time.
[00144] In an embodiment, the processing means together with warning or signaling means, such as visual and/or acoustic means, e.g. display 28 and/or a warning horn, provide a permanent warning of the achievement and/or non-achievement of the target position 30, taking into account a predetermined accuracy value (e.g. a maximum acceptable distance of 0.5 mm or 1 .0 mm), so as to provide the physician with continuous information as to whether he/she is already in the "green" zone, where the medical instrument may be operated, or if he/she is still in the "red zone" too far from the target position 30.
[00145] The error values, also understood as accuracy values actually achieved, may be entered in a report, e.g. together with images or inserted in the images of the target tissue 3 and of the selected target positions 30.
[00146] Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
[00147] In a further embodiment, apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to compare (shape and/or position of) outer edges of the target tissue 3, such as a prostate, identified in images generated by the visualization means 5 with (shape and/or position of) outer edges of the same target tissue 3 identified in corresponding images previously acquired and stored, such as graphical model, vector graph, 3D wireframe model or other type of model of the target tissue 30.
[00148] Based on said comparison, the processing means are adapted to identify areas of the target tissue with an evidence of shape and/or volume change. In many clinical conditions, such as prostate cancer, these identified areas are of considerable interest in the examinations and in subsequent surgeries.
[00149] Such identified areas may be reported in a report, e.g. together with images or highlighted in the images of the target tissue 3, along with values of shape, size or volume change.
[00150] Such a report may be generated automatically or at the user's request, e.g. through the control unit 8.
[00151] The processing means, e.g. the control unit 8, may further be adapted to prepare and store in a memory, in particular a portable data medium, a collection of images of the target tissue 3 acquired in first acquisition planes (e.g. transversal planes) mutually spaced at predetermined pitches, and second acquisition planes (e.g. longitudinal planes) mutually spaced at predetermined pitches and transversal to the first acquisition planes. A database of images (such as of the "dicom" type) is thus obtained, referred to a plurality of "slices" of the target tissue 3 similar to an MRI, but with the addition that the target tissue 3 is here shown both in transversal "slices" and in longitudinal "slices". [00152] According to an embodiment, apparatus 1 may comprise processing means, e.g. the control unit 8, adapted to:
[00153]- access a memory containing additional data or images previously acquired by direct or indirect visualization and diagnosis means, different from the visualization system 5, such as magnetic resonance imaging,
[00154]- generate a combined visualization of one or more images generated by the visualization system 5 and said additional data and/or images.
[00155] For example, the current position of the medical instrument 2 may be displayed, such as on display 28, by means of an image of the medical instrument generated in real time by the visualization system 5 and overlap the image of the medical instrument 2 with the additional data or images of the target tissue 3, which could for example reveal some details or features of the tissue which are not easily visible in ultrasound scanning images but very useful to the physician when positioning the medical instrument 2.
[00156] In a further embodiment, apparatus 1 may comprise simulation means, e.g. the control unit 8, adapted to display, for predetermined positions of the visualization system 5, images of the target tissue 3 previously acquired by the visualization system in the same predetermined positions. Thereby, before the actual surgery on the patient, the physician can simulate and carry out, through an analysis of the images of the previous surgery or examination, a pre-selection of target points 30 that he/she wants to reach in the subsequent examination or surgery, and experiment or verify by simulation without patient, positioning paths of the medical instrument 2 (such as a biopsy needle) and any critical issues of the target positions 30, particularly in the peripheral areas of the target tissue 3.
[00157] In an embodiment, apparatus 1 comprises a signal interface for connecting a remote user interface, such as a computer, which allows data and/or images stored in a memory of apparatus 1 to be accessed, which memory could be an internal memory or a remote or external memory, used by apparatus 1.
[00158]The 2D or 3D visualization of the target tissue, e.g. a prostate gland, and of the corresponding target points of intervention or sampling is thus also enabled remotely for authorized medical staff, e.g. the anatomopathologist, who can directly associate the acquired images with the results of examinations on the collected tissues.
[00159] In return, processing means, e.g. the control unit 8, of apparatus 1 can generate a combined visualization, e.g. on display 28, of images of the target tissue 3 together with features identified by the examination of samples taken, e.g. histological examination results, of the target tissue 3 in the target positions 30. [00160]Those skilled in the art will certainly appreciate that some data storage and processing features and functions may be assigned to one or more computers placed directly on board of apparatus 1 or remotely in a wired or wireless computer network.
[00161] By way of non-limiting example, an operating mode of apparatus 1 and the corresponding method for positioning a biopsy needle 2 in a trans-perineal prostate biopsy are described hereinafter.
[00162] In a first biopsy session, the patient is positioned with respect to apparatus 1 so that the reference plate 9 in "initial position" is located externally to the patient very close to the perineum.
[00163]After or before the apparatus-patient positioning, apparatus 1 is put into operation, using a start control, after which the control unit 8 with the aid of the touch screen 28 prompts for the input of identification data of the intervention (i.e. the physician's name, the patient's name, identification data and interfacing data of the ultrasound probe 5 used, etc.).
[00164] Apparatus 1 then assists the physician in an initial step of mapping the patient's prostate (figures 9, 10), guided by the touch screen 28 controlled by the control unit 8, in which the translation means 18 position the ultrasound probe 5 from a rest position relatively far from the patient to a starting position close to the patient and in the vicinity or in alignment with the plane of the reference plate 9. From the starting position, any further movement of the ultrasound probe 5 requires a manual control of the physician using the translation 20 and rotation 21 control knobs. Irrespective of the amplitude of rotation of the control knobs 20, 21 , the control unit 8 drives the translation 18 and rotation 19 means so that they move ecograph 5 by a single linear or rotational pitch of predetermined magnitude for each actuation of knobs 20, 21 , and acquires the corresponding transversal , ultrasound scanning image transmitted by ecograph 5 for each linear pitch and the corresponding longitudinal ultrasound scanning image transmitted by ecograph 5 for each angular pitch.
[00165] By entering a "start" command and an "end" command via the touch screen 28, corresponding to translation positions of ecograph 5, the transversal image planes of which define the extension of the prostate in distal-proximal direction, the physician communicates the position of the prostate in the guide direction 14 of apparatus 1 to the control unit 8.
[00166] Using the transversal ultrasound scanning images acquired during the translation of ecograph 5, the control unit 8 determines a three-dimensional model of the external profile of the prostate (initial mapping).
[00167] In order to increase the mapping accuracy, the control unit 8 via the touch screen 28 displays selected ultrasound scanning images acquired and prompts the physician to outline the prostate margins in said selected images using a contour line (figure 11). Using the set of contour lines confirmed by the physician, the control unit 8 calculates and possibly displays a 3D wire-frame model 40 of the patient's prostate and calculates the spatial relationship (relative vectorial position) between the 3D model of the prostate and the reference plate 9 in "initial position".
[00168] The mapping step is followed by a step of selecting one or more target positions 30 for carrying out the biopsies and then the biopsy itself. To this end, and depending on the proximal-distal extension of the prostate, the translation means 18 position the ultrasound probe 5 in a translational "image acquisition" position so that the longitudinal ultrasound transducer of the probe substantially covers the entire distal-proximal length of the prostatic tissue of interest (target tissue 3).
[00169] By displaying on display 28 the transversal ultrasound scanning images acquired and longitudinal ultrasound scanning images generated in the current longitudinal visualization plane of the ecograph, the control unit 8 prompts the physician to select the target positions 30 (figure 12) and stores them in a database of a memory on board of apparatus 1 or of a remote memory.
[00170] Already at this stage, but particularly during the positioning of the biopsy needle 2, the laser projector 29 projects a line indicative of the current longitudinal visualization plane of ecograph 5 on the distal surface 10 of the reference plate 9, which line allows the physician to associate the ultrasound scanning image shown on display 28 with the actual anatomical situation of the patient (figure 5).
[00171] The control unit 8 generates and displays on display 28 or through the laser projector 29 a unique indication of the guide channel 1 1 to be used to guide the biopsy needle 2 to the selected target position 30.
[00172] In order to speed up the identification of the correct guide channel, the laser projector 29 projects a light indication of the corresponding inlet opening 31 directly on the distal surface 10 of the reference plate 9, for example with a circle around the opening.
[00173] In order to assist the physician in the decision about the insertion depth of the biopsy needle 2 guided by the guide channel of the reference plate 9, the control unit 8 displays on display 28 the longitudinal ultrasound scanning image in the visualization plane which includes the target position 30 and in which the progress of the biopsy needle into the target tissue 3 may be seen (figure 13).
[00174] In order to reduce the error margin, the control unit 8 controls the depth adjusting means 34 to position the small frame with the abutment surface 35 in an end-of-stroke position for the biopsy needle 2 in which the tip of the biopsy needle 2 reaches the selected target position 30.
[00175] Thereby, the scheduled biopsies may be carried out in sequence.
[00176] In a subsequent prostate biopsy session of the same patient, the same process steps as the first session are substantially carried out, but without the 3D wire-frame model 40 generation of the prostate which was stored during the first session and which is also reused for subsequent sessions.
[00177] In order to compensate for possible errors or changes in the patient's positioning with respect to apparatus 1 , the control unit 8 determines a deviation magnitude between the position of the prostate during the current biopsy session and the first biopsy session. To this end, the control unit 8 determines the visualization on display 28 of ultrasound scanning images acquired during the second session (current session) in two visualization planes not parallel to each other, and precisely a transversal ultrasound scanning image and a longitudinal ultrasound scanning image, as well as the portions of the 3D wire-frame model 40 of the prostate generated in the first session (previous session) for the same "image acquisition" positions of ecograph 5, thus highlighting a deviation of the position of the 3D model with respect to the current anatomical situation (figure 14).
[00178] At this point, the control unit 8 prompts the user to overlap the portions of the 3D wireframe model 40 of the prostate as precisely as possible on the ultrasound scanning images of the prostate displayed, in particular through a "displacement" of the wire-frame model 40 along three orthogonal axes, e.g. by means of special functions available on the touch screen 28 (figure 14).
[00179] Based on this overlap displacement, the control unit 8 quantitatively determines the deviation magnitude of the prostate position with respect to the initial position thereof, and selects and displays the unique identification code of the position adapter 39 on display 28 which is suitable for compensating for such a deviation (figure 15).
[00180] The user inserts the position adapter 39 suggested by apparatus 1 between the reference plate 9 and the second mounting portion 16 and fixates the connection between them, resulting in the adjustment of the position of the guide channels 1 1 in a direction transversal to the guide direction and a compensation of the patient positioning in the two dimensions of the plane of the reference plate 9.
[00181]The compensation of the patient positioning error in the third dimension is carried out by an additional adjustment of the depth reference 33.

Claims

1. An apparatus (1) for positioning a medical instrument (2) with respect to a target tissue (3), employed in combination with an indirect or remote visualization device, comprising:
- reference means (9) having a plurality of guide channels (11) arranged in a predetermined manner and sized so as to allow the guided passage of the medical instrument (2) through said guide channels (11),
- mounting means (6, 39) for mounting the reference means (9) in a determined position with respect to the visualization device (5) suitable to generate an image of the target tissue (3),
- processing means (8) which determine:
- a spatial relationship between the reference means (9) and an image of the target tissue (3) generated by the visualization device (5),
- a misalignment magnitude between at least one of the guide channels (11) and a target position (30) selected in the image of the target tissue (3),
- transversal adjusting means (38) which allow an adjustment of the position of the reference means (9) with respect to the visualization device (5) in an adjustment plane orthogonal to the guide direction (14) so as to compensate for the misalignment between the selected target position (30) and the corresponding guide channel (31).
2. The apparatus (1) according to claim 1 , comprising:
- translation means (18) for a displacement of the visualization device (5) along a longitudinal axis (17) and rotation means (19) for a rotation of the visualization device (5) about the longitudinal axis (17),
- detection means (26, 27) for the detection of the translational and rotational position of the visualization device (5) with respect to a predetermined rest position,
- control means (8) in signal connection with the visualization device (5) and with the position detection means (26, 27) and configured to control the translation means (18) and the rotation means (19) in dependency of manual positioning commands of a user and to displace the visualization device (5) with pitches of a predetermined magnitude and to automatically acquire an image generated by the visualization device (5) for each displacement pitch which is carried out.
3. The apparatus (1) according to claim 1 or 2, comprising processing means (8) which determine a misalignment magnitude between a target position (30) selected in the generated image of the target tissue (3) and one of the guide channels (11).
4. The apparatus (1 ) according to claim 3, wherein the processing means (8):
- determine a spatial relationship between the reference means (9) in an initial position thereof and the visualization device (5) in an image acquisition position thereof,
- determine a selection or a selection request of the target position (30) in the acquired image of the target tissue (3), with respect to which the medical instrument (2) has to be arranged,
- determine a spatial relationship between the reference means (9) and the selected target position (30) as a function of the spatial relationship between the initial position of the reference means (9) and the image acquisition position of the visualization device (5) and of the coordinates of the selected target position (30) in the acquired image of the target tissue, and
- determine the misalignment magnitude between the selected target position (30) and a selected guide channel (31) in dependency of the spatial relationship between the reference means (9) and the selected target position (30),
wherein said transversal adjusting means (38) are adapted to at least partially compensate for said determined misalignment.
5. The apparatus (1) according to claim 3, comprising processing means (8) for:
- determining a deviation magnitude between:
A) the spatial relationship between the reference means (9) in the initial position and the selected target position (30), and
B) a reference spatial relationship between the reference means (9) in the initial position and the same target position (30) in a previously acquired reference image of the same target tissue (3),
wherein said transversal adjusting means (38) are adapted to at least partially compensate for said determined deviation.
6. The apparatus (1) according to one of the claims 3 to 5, comprising a plurality of position adapters (39) of different sizes corresponding to different deviation values between the guide means (9) and the selected target position (30), said position adapters (39) being able to be mounted with a certain mutual positioning between the reference means (9) and the visualization device (5) and having unique identification means for each size.
7. The apparatus (1) according to claim 6, comprising processing means (8) which select one of the position adapters (39) as a function of a determined deviation magnitude, and indication means (28) which indicate to the user the selected position adapter (39).
8. The apparatus (1) according to one of the preceding claims, wherein the reference means (9) form a distal surface (10) and said plurality of guide channels (11) forms inlet openings (12) in the distal surface (10), said apparatus (1) further comprising:
- visual signaling means (29) generating on said distal surface (10) of the reference means (9) a visual signaling as a function of the spatial relationship between the reference means (9) and the target tissue (3) to aid in the positioning of the medical instrument (2) with respect to the target tissue (3) through a selected opening (31) of the inlet openings (12).
9. The apparatus (1) according to claim 8, comprising:
- means (8) for determining a combined displaying of the generated image of the target tissue (3) and of the positions of the guide channels (11) of the reference means (9) on a display (28) of the apparatus (1),
- means (8, 28) for allowing the user to select, in the generated image of the target tissue (3), at least one target position (30) with respect to which the medical instrument (2) has to be arranged,
- means (8) for determining a spatial relationship between the reference means (9) and the selected target position (30),
wherein the visual signaling means (29) generate said visual signaling (32) on the distal surface (10) as a function of the spatial relationship between the reference means (9) and the selected target position (30).
10. The apparatus (1) according to claim 8 or 9, wherein the visual signaling (32) on the distal surface (10) comprises at least one of:
- an indication of the position of a visualization plane of the visualization device (5) containing the target tissue (3) or a target position (30),
- an indication of the position of a current image plane of the visualization device (5),
- an indication of the selected inlet opening (31),
- an image representing the target tissue (3) or a target position (30),
- an image of the target tissue (3) in a current visualization plane of the visualization device (5).
11. The apparatus (1) according to one of the claims 8 a 10, wherein the visual signaling means (29) comprise a laser projector mounted to a support structure (4) of the apparatus (1)·
12. The apparatus (1) according to one of the preceding claims, comprising a depth reference (33) the position of which with respect to the guide channels (11) is adjustable in the guide direction (14) and fixatable so as to provide an insertion end-of-stroke position of the medical instrument (2) in a selected channel (31) of the guide channels (11).
13. The apparatus (1) according to claim 12, comprising: - processing means (8) for determining the end-of-stroke position of the medical instrument (2) as a function of a geometric parameter of the medical instrument (2) and of the spatial relationship between the reference means (9) and a target position (30) selected in the image of the target tissue (3),
- depth adjusting means (34) which adjust and fixate the position of the depth reference (33) as a function of the determined end-of-stroke position.
14. The apparatus (1) according to claim 12 or 13, wherein the depth reference (33) comprises an abutment surface (35) adapted to engage a corresponding counter-abutment surface (36) of the medical instrument (2) in the end-of-stroke position.
15. The apparatus (1) according to claim 14, wherein the abutment surface (35) is formed in a small frame arranged in a distal position with respect to the reference means (9) and translatable in the guide direction (14) by an electric motor (37) of the depth adjusting means (34).
16. The apparatus (1 ) according to one of the claims 6 a 9, wherein the depth reference (33) comprises an end-of-stroke indicator adapted to interact with a corresponding reference device of the medical instrument (2) so as to provide a visual or acoustic warning which signals when the medical instrument (2) is in the end-of-stroke position.
17. The apparatus (1) according to one of the preceding claims, wherein the reference means (9) comprise a planar reference plate (9) forming the guide channels (11) mutually equidistant in a Cartesian grid and oriented in a guide direction (14) orthogonal to a plane (15) of the reference plate (9).
18. The apparatus (1) according to one of the preceding claims, wherein the visualization device is an ecograph (5) elongated along a longitudinal axis (17) with an ultrasound transducer in a longitudinal visualization plane radial to the longitudinal axis (17) and an ultrasound transducer in a visualization plane orthogonal to the longitudinal axis (17).
19. The apparatus (1) according to one of the preceding claims, comprising processing means which calculate an error value between a target position (30) and a position actually reached by an interested portion of the medical instrument (2) for one or more selected target positions (30).
20. The apparatus (1) according to one of the preceding claims, comprising processing means which:
- compare characteristics of shape or position of outer edges of a target tissue (3) identified in images generated by the visualization means (5) with characteristics of shape or position of outer edges of the same target tissue (3) identified in previously acquired and stored images, and
- based on said comparison, identify areas of the target tissue (3) with an evidence of shape and/or volume change.
21. The apparatus (1) according to one of the preceding claims, comprising processing means which:
- access a memory containing additional data or images previously acquired by additional visualization or diagnosis means, different from the visualization system (5),
- generate a combined visualization of one or more images generated by the visualization system (5) and said additional data or images.
22. The apparatus (1) according to one of the preceding claims, comprising simulation means adapted to display, for determined positions of the visualization system (5) and in the absence of a patient, images of the target tissue (3) previously acquired by the visualization system (5) in the same determined positions, so as to allow a selection of target positions (30) in the previously acquired images of the target tissue (3) and a recording of the selected target positions (30) or a positioning simulation of the medical instrument (2) in the absence of a patient.
23. A method for positioning a medical instrument (2) with respect to a target tissue (3), said method being employed in combination with an indirect visualization device (5), and comprising the steps of:
- positioning reference means (9) with respect to the visualization device (5), in a region which is near but external to a patient, which facilitates the access to the target tissue (3), said reference means (9) having a plurality of guide channels (11) arranged in a predefined manner and dimensioned so as to allow the guided passage of the medical instrument (2) through said guide channels (11) in a guide direction,
- determining a spatial relationship between the reference means (9) and the visualization device (5),
- obtaining an image of the target tissue (3) by the visualization device (5),
- selecting, in the obtained image of the target tissue (3), a target position (30) with respect to which the medical instrument (2) has to be arranged;
- determining a spatial relationship between the reference means (9) and the selected target position (30),
- determining a misalignment magnitude between the selected target position (30) and at least one of the guide channels (11),
- adjusting the position of the reference means (9) with respect to the visualization device (5) in a direction transversal to the guide direction so as to compensate for the misalignment between the selected target position (30) and the guide channel.
PCT/IB2016/050878 2015-02-27 2016-02-18 Indirect visualization-assisted apparatus and method for positioning medical instruments WO2016135595A1 (en)

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