WO2011160686A1 - Guide d'alignement pour biopsie - Google Patents

Guide d'alignement pour biopsie Download PDF

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Publication number
WO2011160686A1
WO2011160686A1 PCT/EP2010/058888 EP2010058888W WO2011160686A1 WO 2011160686 A1 WO2011160686 A1 WO 2011160686A1 EP 2010058888 W EP2010058888 W EP 2010058888W WO 2011160686 A1 WO2011160686 A1 WO 2011160686A1
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WO
WIPO (PCT)
Prior art keywords
lesion
breast
holding tool
probe
surgical
Prior art date
Application number
PCT/EP2010/058888
Other languages
English (en)
Inventor
Renzo Marco Giovanni Brun Del Re
Original Assignee
Renzo Marco Giovanni Brun Del Re
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Renzo Marco Giovanni Brun Del Re filed Critical Renzo Marco Giovanni Brun Del Re
Priority to PCT/EP2010/058888 priority Critical patent/WO2011160686A1/fr
Priority to PCT/EP2011/060565 priority patent/WO2011161218A1/fr
Priority to EP11727977.8A priority patent/EP2584973A1/fr
Publication of WO2011160686A1 publication Critical patent/WO2011160686A1/fr

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B10/0041—Detection of breast cancer
    • 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
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00796—Breast surgery
    • A61B2017/008—Removal of tumors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0237—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery
    • A61B2017/0243—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery for immobilizing local areas of the heart, e.g. while it beats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms

Definitions

  • the present invention relates to the field of minimally invasive surgery and particularly, but not exclusively, to the excision for analysis of tissue structures such as lesions or tumors within the human breast or other parts of the body.
  • a human breast will be used in this description, although it should be understood that this is by way of example only, and that the device and method of the invention are intended for use on any part of the human body where a predetermined region is to be located, sampled and/or removed from within a surrounding (often relatively soft) tissue mass, and in which the lesion or other target biopsy region is sufficiently near the surface of the body that it can be located or manipulated by applying pressure on the outer surface of the body - by the surgeon's pressing his or her fingers pressing the outer surface of the breast, for example.
  • the application of the invention should also be understood to include veterinary interventions on animals.
  • ultrasound scanning also known as sonography
  • sonography for monitoring the biopsy procedure.
  • other scanning techniques such as X-ray or magnetic resonance imaging, may be used in place of ultrasound.
  • Biopsy needles conventionally include a sharp pointed portion for introducing through the surrounding tissue of the breast, and a sampling knife mechanism located near the sharp tip of the needle.
  • the sampling knife mechanism cuts away a small volume of the target lesion, and the excised portion can then be withdrawn, for example by suction through the tubular body of the needle.
  • Multiple tissue portions can be excised in this way during one operation, or in repeated operations.
  • the target lesion tissue and the surrounding tissue often have significantly different consistencies.
  • a cancerous lesion may, for example, be significantly firmer than the surrounding soft tissue of the breast.
  • the lesion can be located and/or manipulated by applying pressure at one or more locations on the surface of the body.
  • minimally invasive biopsies can be performed with the surgeon using his or her fingers to find and manipulate the lesion from outside the breast, for example with the aid of a scanner probe.
  • the surgeon may apply pressure on the soft mammary tissue, using the patient's rib-cage as a firm basis against which to press. In other parts of the body, this pressing basis would be provided by other firm or rigid structures, for example muscle or bone mass, beneath the tissue surrounding the target lesion.
  • the biopsy needle may be steered to a point to one side of the target lesion, whereupon the tissue to be excised will be taken from that side of the lesion.
  • the distal end of the biopsy needle is provided with a drawer-like opening into which neighboring tissue can be drawn by applying a vacuum to the proximal end of the needle, before actuating a knife mechanism to slice off the material within the drawer-like cavity, whence the excised material can be withdrawn by suction, for example, or mechanically, through the body of the needle as described above.
  • the outer sleeve is first guided to the sampling region, whereupon the needle core is advanced into the lesion area and then withdrawn through the sleeve with the sample. This process may be repeated as required, with the needle sleeve remaining in position.
  • the biopsy needle needs to be inserted directly into the tissue of the lesion, which can be significantly harder or firmer than the surrounding tissue, and can therefore present greater resistance to penetration by the needle. It can thus be difficult to push the needle into the lesion tissue without pushing the lesion out of the way and slipping past and damaging the adjacent tissue.
  • needles have been developed which incorporate a tip which can be actuated to shoot forward quickly, into the lesion, thereby reducing the risk of slipping past and damaging good tissue.
  • Such needles can also include a drawer-like knife mechanism as mentioned above.
  • a needle When a needle is used to penetrate the centre of a lesion, it can also be arranged to rotate, so that multiple tissue samples can be taking from different parts of the lesion.
  • Other biopsy instruments used in such operations may equally include electrical, harmonic or ultrasonic instruments, which cut the tissue using electric current, heat or vibration.
  • a recent development is an electric biopsy instrument which is introduced as a narrow needle through the breast tissue, then opens up into an umbrella or scoop shaped tool when the tool is in position. The tool is then rotated or otherwise actuated to cut around the target lesion, whereupon the excised tissue is withdrawn whole or in sections through the surrounding tissue.
  • the term "needle” as used in this text should be understood to include all such biopsy instruments.
  • the minimally invasive biopsy process is conventionally monitored by the operator using a scanning device such as an ultrasonic scanner probe held against the outside of the breast.
  • the scanner probe is commonly held by the surgeon or an assistant, or it may be positioned and held in place by other means, such as a static mount or a robotic arm.
  • a sonographic image (or its equivalent, if other scanning techniques are used) is displayed to the operator as he or she carries out the biopsy, and the operator uses the visual information to locate the target lesion, to steer the needle towards it, and then to monitor the progress of the biopsy as it is performed.
  • the ultrasound scanner probe, or sonde conventionally has a well- defined scanning aperture, or zone, within which a tissue structure can be scanned and visually portrayed on a display device.
  • the scanning aperture of a scanner probe used for minimally invasive breast biopsies may have a substantially planar, fan-shaped profile, for example.
  • Minimally invasive biopsy techniques as described above can be performed comparatively quickly and cheaply, but nevertheless effectively and with relatively uncomplicated equipment.
  • Minimally invasive techniques also significantly reduce the amount of discomfort experienced by the patient, as well as minimizing the subsequently visible outward signs of the procedure, such as scarring or misshaping. For these reasons, minimally invasive breast biopsies are often preferred where possible.
  • the lesion and the biopsy needle must both be kept within the aperture of the scanner probe and remain so while the biopsy proceeds. Since the human breast is a relatively large, flaccid structure when compared with the small, firm lesion within it, great dexterity can be required to bring the needle and the lesion together. In addition, if a mobile or hand-held scanner probe is used, then the probe must also be kept in an orientation which allows the operator to view both the lesion and the needle on the sonography image. The scanner probe must be in close contact with the surface of the breast in order to achieve good ultrasound imaging of the tissue, and the scanner probe is therefore pressed against the outer surface of the breast after coating the skin with lubricating jelly to improve the contact between the scanner probe and the breast.
  • Pressing the probe on to the breast in this way can have the effect of displacing the tissue inside the breast, including the lesion to be detected.
  • the scanning probe can thus cause the lesion to be displaced out of the scanning plane and therefore out of the view of the operator.
  • the operator must therefore exercise great skill in judging how much pressure to exert on the scanning probe in order to achieve good scanning contact, but without pushing the lesion sideways out of view.
  • the object of the present invention is therefore to overcome the above and other problems by providing a holding tool, and a method of using the tool, which enables an operator to restrain a target lesion while he or she guides a biopsy needle to the target lesion, with reduced risk of injury to the patient and to the operator.
  • the invention envisages a surgical holding tool for limiting movement of a predetermined target tissue structure, hereafter referred to as the lesion, within a body of soft, mobile tissue, hereafter referred to as the breast, such that the lesion is restrained in a holding region for inspection of the lesion or removal of at least a portion of the lesion using a minimally invasive biopsy needle,
  • the surgical holding tool being characterized by a pressure point assembly for pressing against the outer surface of the breast in the vicinity of the lesion, the pressure point assembly comprising: a holding part with which the pressure point assembly can be held pressed against the surface of the breast, a first lateral pressing element and a second lateral pressing element, a needle-insertion aperture through which a biopsy needle can be inserted into the tissue of the breast in the vicinity of the lesion while the pressure-point assembly is pressed against the surface of the breast, the first and second lateral pressing elements being fixed in a mutually cooperating configuration such that, when the pressure point assembly is pressed against the surface of
  • the surgical holding tool comprises support means for securing a scanner probe to the pressure point assembly such that the scanning zone of the scanner probe is at least partially coincident with the holding region.
  • the holding part and the support means may be combined into one.
  • the scanner probe may be a sonography sensor.
  • the pressure point assembly comprises a terminal pressing element fixed in a substantially rigid, mutually cooperating configuration with the first and second lateral pressing elements such that, when the pressure point assembly is pressed against the surface of the breast over the lesion the terminal pressing element depresses the tissue of the breast on a distal side of the lesion, away from the needle- insertion aperture so as to urge the lesion to resist an axial force exerted on the lesion by the insertion of the biopsy needle.
  • the pressure point assembly may have a substantially U-shaped or V-shaped form.
  • the first and second lateral pressing elements may be formed as the sides of the U-shape or V-shape and the terminal pressing element is formed as the arc of the U-shape or the vertex of the V-shape.
  • one or more of the first, second lateral pressing elements or the terminal pressing element may be shaped so as to present a substantially concave pressing face towards the breast, the or each said concave-faced pressing element thereby having two end portions which exert greater pressure when pressed on to the breast than the pressure exerted by a middle portion, located between the two end portions.
  • one or more of the first and second lateral pressing elements or the terminal pressing element is shaped so as to present a substantially convex pressing face towards the breast, the or each said convex-faced pressing element thereby having a middle portion, located between two end portions, which exerts greater pressure when pressed on to the breast than the pressure exerted by the two end portions.
  • the surgical holding tool comprises one or more alignment guides for cooperating with a biopsy needle inserted into said insertion aperture to keep the inserted biopsy needle aligned with the holding region and/or the scanning zone of the scanner probe.
  • the scanner probe and the surgical holding tool are integrated into one construction.
  • the support means being adapted to receive more than one type of scanner probe.
  • the support means and/or the holding part comprises adjustment means for adjusting the position and/or orientation of the scanner probe with respect to the pressure point assembly.
  • the invention also envisages a minimally invasive method of removing a portion of a predetermined target tissue structure, hereafter referred to as the lesion, within a body of soft tissue, hereafter referred to as the breast, the method comprising: a first step to locating the lesion in the breast, a second step of inserting a biopsy needle into the breast, a third step of guiding the biopsy needle towards the lesion, a fourth step of using the biopsy needle to remove at least a portion of the lesion, the method being characterized by a fifth step, performed during the third and/or fourth steps, of, using a surgical holding tool as described above, pressing the pressure point assembly of the surgical holding tool against the outer surface of the breast so as to limit movement of the lesion in a holding region within the breast.
  • the first step includes using a scanning probe to locate the lesion
  • the third step includes using scanning information provided by the scanning probe to guide the biopsy needle towards the lesion
  • the fifth step includes aligning the scanning zone of the scanning probe with the holding region.
  • the method includes a setup step of adjusting the support means of the surgical holding tool such that the target zone of the scanner probe is aligned with the holding region of the holding tool so as to permit the holding tool and the scanner probe to be manipulated as one unit while the target zone and the holding region are held in a fixed orientation to each other by the support means of the surgical holding tool.
  • Figure 1 illustrates in perspective view an example of a surgical holding device according to the invention.
  • Figure 2 shows how the surgical holding device of figure 1 can be used during a minimally invasive biopsy procedure.
  • Figures 3a to 3d show an example handle-adjustment mechanism.
  • Figure 4 show in perspective view another example surgical holding tool according to the invention.
  • Figures 5 to 8 show perspective views (figures 5 and 6) and cross- sectional views (figures 7 and 8) illustrating how the surgical holding tool of figure 4 can be used in a minimally invasive biopsy procedure.
  • FIG. 1 shows an example of a device according to the invention.
  • the device comprises a U-shaped pressure point assembly 3, 4, 5 having two side arms (lateral pressing elements) 3 and 4 and an end part (terminal pressing element) 5.
  • the U-shaped assembly 3, 4, 5 of the example has the shape of a two-pronged fork. It can be made, for example, of a single piece of steel bar, bent or otherwise shaped into the shape shown. Alternatively, the assembly can be made as three separate pressing elements joined by a substantially rigid structure.
  • a handle, or holding part, 9 is attached to the holding tool 3, 4, 5 and is designed such that the handle 9 can be held by the hand of an operator and used to manipulate the holding tool into position and press the holding tool against the breast or other relatively soft part of the patient's body.
  • the handle 9 can also be shaped and arranged such that it can be held or connected to a robot arm for robot-assisted surgery.
  • Figure 2 shows how the holding tool 1 of figure 1 can be pressed against the breast 10 of a patient containing a lesion 2.
  • the target lesion contained within the breast is urged by the three pressing elements into a holding region defined by the combined shape of the pressing elements 3, 4 and 5.
  • the biopsy needle is inserted through an aperture A left open for the purpose.
  • the aperture A is merely a space between the ends of the two lateral pressing elements 3 and 4.
  • the terminal element 5 acts on the lesion to urge it against the axial force of the
  • the combined urging forces on the lesion of the three pressing elements 3, 4 and 5 have the effect of trapping the lesion 2 in a holding region from which it cannot move when the needle 1 1 , 12 is inserted.
  • the needle 1 1 , 12 can be accurately inserted into or near to the lesion 2 without fear of the lesion moving. This reduces the risks of accidental damage to the surrounding tissue structures, as discussed above, and the operator's hand is kept well clear of the region where the needle is being inserted.
  • Figures 3a to 3d show an adjustable handle 9, 9' for the holding tool 1 , and illustrate how the angle and/or orientation of the handle 9 can be changed relative to the pressure point assembly 3, 4, 5.
  • An example is shown in figures 3c and 3d of how the adjustment of the angle of the handle 9 can be carried out, with the handle pivoting around axis 30 and adjusted by threaded screw 32 turning against static part 31 .
  • Figure 4 shows how the pressure point assembly 3, 4, 5 can be provided with a stable mount for attaching a scanning probe holder 7 using an attaching means such as a butterfly nut 8.
  • the scanning probe holder 7 is shown shaped to accept a particular type of ultrasonic scanning probe having an oval cross-section.
  • other scanning probes have different forms and would require differently-shaped holders 7.
  • a holder 7 could be attached which is designed to accept multiple types of scanning probe.
  • the attaching means 8, illustrated as a butterfly nut could equally be a magnetic a fastener, a Velcro® type fastener or any other kind of suitable means of fastening the probe to the holding tool such that the probe is kept steady relative to the various elements of the holding tool.
  • FIGs 5 to 8 show different views of the same scene, in which the holding device 1 is used to limit the movement of a lesion 2 while a biopsy is performed using scanner probe 20 and biopsy needle 1 1 .
  • Scanner probe 20 is connected via cable 21 to a sonographic display system (not shown).
  • Biopsy needle 1 1 is shown inserted into the breast and located near to the lesion 2.
  • the needle 1 1 is illustrated with a cavity 12 for collection of the biopsy sample(s) as described above. Note that in some operations, the needle would be inserted into the target lesion 2 itself.
  • the holding tool 3, 4, 5 is shaped such that, when pressed into the soft tissue of the breast 10 over the lesion 2 within, the lateral parts 3 and 4 limit the lateral movement of the lesion 2 between the two lateral parts 3 and 4 in a direction substantially orthogonal to the two lateral parts 3 and 4.
  • the end part 5 limits the movement of the lesion 2 in the axial direction (ie a direction parallel to the lateral parts 3 and 4, to a principal axis of the holding tool 3, 4, 5 and/or in the plane of insertion of the biopsy needle 1 1 ).
  • the lateral pressing elements 3 and 4 are shaped so that they present a concave profile to the breast 10. Each lateral part 3, 4 thus
  • the holding tool 3, 4, 5 has been illustrated as a U-shape, but it could also be a V-shape, or a circle, or an ellipse, or any shape which provides sufficient pressure points to urge the lesion 2 into a holding region when the holding tool 3, 4, 5 is pressed against the breast 10 over the lesion 2.
  • the holding tool 3, 4, 5 may comprise a number of discrete pressure elements, for example, arranged to define a holding region between them. The exact number, shape and construction of the holding tool 3,
  • the side elements 3 and 4 and/or the end element 5 may be constructed of lightweight tubular material such as an aluminium alloy, or of any suitable material such as or carbon-reinforced polymer, or stainless steel, or even a resilient plastics material such as high-density polyethylene.
  • the holding tool 3, 4, 5 may be manufactured in a particular predetermined shape, or it may alternatively be made from a material whose shape can be plastically or mechanically altered by the operator to suit different types of operation, or to take account of the softness or otherwise of the breast tissue of a particular patient, or of the size or depth of the lesion 2, as described above.
  • the device illustrated in the figures is also shown with an attached support member 6, in this example case a roughly square planar piece, to which a probe holder 7 is attached by means of attaching means 8, such as a nut and bolt.
  • the probe holder 7 is shaped to receive a scanning probe 20 and to hold the probe 20 stationary relative to the holding tool 3, 4, 5.
  • the probe holder 7 is illustrated without any separate locking or tightening means for fastening the probe 20 in the holder 7.
  • the probe holder 7 is designed to receive the scanning probe 20 and hold it using the elasticity of the probe body (for example a resilient moulded body or covering material), or the elasticity of the holder 7 itself (the probe holder 7 may be fabricated with a slight elasticity to clamp the probe 20, for example).
  • any conventional clamping or fastening means may be provided.
  • the probe holding arrangement can be designed with interchangeable holders 7 for different shapes of scanning probe 20, or one or more holders 7 can be provided which each accept a number of different shapes of scanning probe 20.
  • the attachment means 8 may also be constructed to provide adjustment in one or more rotational and/or linear degrees of freedom. It is useful, for example, to be able to adjust the distance of the probe from the holding tool 3, 4, 5.
  • Figure 6 shows how such an adjustment can be provided with a longitudinal slit allowing adjustment of the height of the holder 7, and therefore of the scanning probe 20 above the pressure point assembly 3, 4, 5, although it will be understood that there are many other ways of constructing this adjustment/fixing mechanism.
  • Such a variable height adjustment allows the operator to balance the requirements of a) ensuring a good contact between the probe 7 and the breast 10, and therefore a good quality sonographic image, and b) exerting the minimum force on the breast 10 necessary to sufficiently restrain the lesion 2 for biopsy (and thus also minimizing the discomfort for the patient).
  • the adjustable attachment means 8 shown in figure 6 also allows the scanning probe 20 to be rotated in the plane of the support plate 6. This may be useful in cases where, for example, the distance between the insertion point of the biopsy needle and the lesion is large, such that the fan angle of the scanner probe 20 cannot display an image of the needle and the lesion at the same time. By rotating the probe holder 7 using the attachment means 8, it is possible to increase the effective viewable scanning angle of the probe 20.
  • the device illustrated in the figures allows the operator to hold the lesion still, with one hand, for biopsy, without risk of injuring that hand with the biopsy needle, and with reduced risk of injuring the patient by pushing the biopsy needle 1 1 to the wrong location. Furthermore, the device allows the operator to set and maintain and alignment of the scanning probe and the lesion with one hand, thus leaving the other hand free for manipulating the biopsy needle 1 1 . The operator is also free to move the device during the operation if necessary, with one hand, while still maintaining the alignment of the probe and the lesion.
  • the operator can change the viewing angle of the scanning probe 20 with one hand, without risking the lesion 2 moving outside the scanning zone, and can thereby easily and quickly gain more spatial information about the lesion 2, the surrounding tissue and the location and/or orientation of the biopsy needle 1 1 .
  • the holding device 1 may also be provided with a needle alignment means (not illustrated) which may be used by the operator to guide the biopsy needle 1 1 along a predetermined path, or in a predetermined plane, as required for the operation being performed, relative to the holding tool 3, 4, 5 and/or relative to the scanning probe 20.
  • the needle alignment means can be implemented as a fixed mechanical guide, for example attached to the holding tool 3, 4, 5, which restricts the needle 12 to following a preset path or plane, or alignment means may be adjustable so that the operator can specify the path or plane at the time of the operation.
  • the scanning probe 20, and/or the ultrasound system to which the probe 20 is attached is provided with sighting means (not illustrated), such as one or more indication marks displayed on the ultrasound display, and representing one or more particular spatial points in the scanning region of the probe 20, which are calibrated with the needle alignment means such that the needle 1 1 is guided towards a location in the breast 10 which coincides with an indication mark shown on the display.
  • sighting means such as one or more indication marks displayed on the ultrasound display, and representing one or more particular spatial points in the scanning region of the probe 20, which are calibrated with the needle alignment means such that the needle 1 1 is guided towards a location in the breast 10 which coincides with an indication mark shown on the display.
  • the surgical holding device has been described in relation to minimally invasive surgical procedures carried out manually by a surgeon. However, it will be understood that the holding device can also be used in a computer-controlled operation using one or more robot arms or actuators to manipulate the surgical holding device, the scanning head and/or the biopsy needle, either under full computer control, following a predetermined operation sequence, or under the live control of a human operator.

Abstract

L'invention concerne un dispositif (1) et un procédé permettant à un opérateur de limiter le mouvement d'une structure (2) de tissus fermes, telle qu'une lésion, à l'intérieur d'un corps de tissus mous (10), tel qu'un sein humain, lors du prélèvement d'un échantillon biopsique employant une technique chirurgicale peu invasive. Le dispositif (1) et le procédé de l'invention permettent à l'opérateur d'utiliser une main pour manipuler une aiguille (11) de biopsie se tenant dans une main, alors qu'il se sert de l'autre main pour empêcher la lésion cible (2) de bouger, pour maintenir la lésion cible (2) positionnée dans l'ouverture de balayage de la sonde (20) à balayage et pour manipuler la sonde (20) à balayage afin de modifier l'angle de visualisation tout en maintenant la lésion cible (2) et l'ouverture de balayage alignées. Selon l'invention, le dispositif (1) peut être conçu pour accepter différents types de sondes (20) à balayage, ou il peut être intégré pour former une seule pièce avec la sonde (20) à balayage.
PCT/EP2010/058888 2010-06-23 2010-06-23 Guide d'alignement pour biopsie WO2011160686A1 (fr)

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PCT/EP2010/058888 WO2011160686A1 (fr) 2010-06-23 2010-06-23 Guide d'alignement pour biopsie
PCT/EP2011/060565 WO2011161218A1 (fr) 2010-06-23 2011-06-23 Outil de support de biopsie portatif
EP11727977.8A EP2584973A1 (fr) 2010-06-23 2011-06-23 Outil de support de biopsie portatif

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WO2022133084A1 (fr) * 2020-12-17 2022-06-23 The Trustees Of Indiana University Guide d'aiguille pour biopsie guidée par ultrasons

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