WO2011161218A1

WO2011161218A1 - Hand-held biopsy support tool

Info

Publication number: WO2011161218A1
Application number: PCT/EP2011/060565
Authority: WO
Inventors: Renzo Marco Giovanni Brun Del Re
Original assignee: Renzo Marco Giovanni Brun Del Re
Priority date: 2010-06-23
Filing date: 2011-06-23
Publication date: 2011-12-29
Also published as: WO2011160686A1

Abstract

Device (1) and method allowing an operator to limit the movement of a firm tissue structure (2), such as a lesion, within a body of soft tissue (10), such as a human breast, during taking of a biopsy sample using a minimally invasive surgical technique. The device (1) and method permit the operator to use one hand to manipulate a hand-held biopsy needle (11, 12), while using the other hand to prevent the target lesion (2) from moving, to keep the target lesion (2) located in the scanning aperture of the scanner probe (20) and to manipulate the scanner probe (20) to change the viewing angle while keeping the target lesion (2) and the scanning aperture aligned. The device (1) can be adapted to accept various different types of scanner probe (20), or it can be integrated into one construction with the scanner probe (20).

Description

Hand-held Biopsy Support Tool

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.

The example of 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 against the outer surface of the breast, for example. The application of the invention should also be understood to include veterinary interventions on animals.

The term "breast" is used in this application to denote mammary tissue, as distinct from the terms "chest", "thorax" and "thoracic cage", which refer to the musculature and rib structure underlying the breasts. Similarly, reference is made in this application to the use of ultrasound scanning, also known as sonography, for monitoring the biopsy procedure. However, this is by way of example only, and other scanning techniques, such as X-ray or magnetic resonance imaging, may be used in place of ultrasound.

Modern techniques for detecting potentially cancerous structures such as suspicious lesions in human breasts have improved significantly in recent years. These, combined with widespread cancer screening programmes and an increasing awareness of self-diagnostic techniques among at-risk patients, mean that it is now common for patients to present with suspected tissue abnormalities at an early stage, when the suspect tissue structures are still small. Whereas a walnut-sized lesion would in the past have been sampled or excised by means of invasive surgery, it is now not unusual for patients to present with lesions the size of an olive, or smaller, which can be sampled, and even completely removed, using a biopsy needle inserted into the breast and directed to the target region. 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. If the lesion is located in a relatively soft body of tissue, and relatively close to the surface of the body (within four or five centimeters, for example), the lesion can be located and/or manipulated by applying pressure at one or more locations on the surface of the body. In such instances, 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. In the case of a breast biopsy, the surgeon may apply pressure on the soft mammary tissue, using the patient's thoracic 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.

Depending on the technique required, 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. According to a known technique, 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. If a biopsy gun is used, in which the needle comprises an inner core which moves in an outer sleeve, 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. In some cases, 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. For such cases, 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. 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. By moving the scanner probe on the surface of the breast, and therefore the scanning zone within the breast, the operator can select a planar, fan-shaped region of the breast tissue to view on the sonographic display.

These and other prior art techniques are described in the book Minimally Invasive Breast Biopsies, edited by Prof. Renzo Brun del Re and published in 2009 as volume no. 173 of a series entitled "Recent Results in Cancer Research" by Springer- Verlag, ISBN 978-3-540-31403-5.

Such 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.

However, it takes great skill on the part of the medical practitioner to be able to manipulate with two hands the breast tissue, the lesion area and the biopsy needle, all while viewing the progress on a scanning imaging display, such that the tip of the needle is brought accurately to the target region and kept in the region while the biopsy sample is taken.

In situations where a target lesion is located near a substantial blood vessel, it is important that the needle be kept away from the vessel to avoid damaging it and potentially causing a haemorrhage within the breast. It is thus all the more important to keep the lesion (and, if possible, the blood vessel) within the scanning aperture while performing the biopsy.

In many cases the operator is obliged to exert pressure on the outside of the breast, using his or her fingers, to restrain the lesion within, while the needle is inserted and guided towards it. Such manipulation requires great dexterity, as well as a great deal of practice, on dummy material for example. However, even when they have acquired the necessary skills, operators still expose themselves and their patients to risk of injury when they attempt to push with one hand a sharp biopsy needle to or through a lesion which is being held by the fingers of the other hand, especially when trying to hold the scanner probe with the other hand at the same time. When using the "shoot-forward" type of biopsy needle mentioned above, the danger of injury is greater still.

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.

Because of the difficulty of navigating the biopsy needle to the correct location and then performing the biopsy while maintaining the needle, the lesion and the scanning probe in the required positions and orientations, significant operating time may be taken up simply by the manual manipulations required. Each movement of the needle inside the breast can potentially cause tissue damage, and some operators find that they have to abandon a biopsy earlier than desired in order to minimize the amount of tissue damage or to reduce the risk of haemorrhage. This may lead to incomplete diagnosis or incomplete removal of a suspect lesion. The object of the present invention is therefore to overcome the above and other problems by providing a hand-held tool, and a method of using the tool, which enables an operator to simultaneously, with one hand, hold a scanner probe in position and restrain a target lesion, while he or she guides a biopsy needle to the target lesion with the other hand, thereby reducing risk of injury to the patient and to the operator.

It is thus an object of the invention to provide a tool, and a method of using the tool, enabling an operator to manipulate the scanner probe, the lesion and the needle simultaneously, without the assistance of another person.

In order to solve the above and other problems, the invention envisages a hand-held biopsy support 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, overlying a firm substructure, hereafter referred to as the thoracic cage, such that the lesion is restrained for sampling by a biopsy needle while using a scanning probe to locate the lesion and monitor the sampling, the hand-held biopsy support tool being continuously manipulatable using one hand to interactively scan, locate and restrain the lesion during a biopsy operation, the hand-held biopsy support tool comprising: a substantially rigid pressure frame shaped for pressing on to the breast, in continuously manipulatable fashion using the one hand, so as to interactively restrain the lesion between the pressure frame and the thoracic cage during the biopsy operation, a needle-insertion aperture through which a biopsy needle can be inserted into a needle entry point of the breast while the pressure frame is pressed on to the breast over the lesion, scanner probe securing means for securing the scanner probe to the pressure frame such that orientation and/or position of the scanner probe relative to the breast can be continuously manipulated, using the same one hand, during the biopsy operation, the pressure frame comprising two lateral pressing elements for pressing against the breast on opposite sides of the lesion such that, when the pressing frame is pressed against the breast, each of the lateral pressing elements urges the lesion towards the other, thereby urging the lesion into a holding region in a scanning plane substantially equidistant between the two lateral pressing elements, the pressure frame further comprising a backstop 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.

According to a variant of the invention, the hand-held biopsy support tool may comprise a needle alignment guide for cooperating with a biopsy needle, for guiding the biopsy needle in alignment with the holding region and/or the scanning plane.

According to a variant of the invention, the pressing frame and the needle-insertion aperture and/or the needle alignment guide are formed such that the pressing frame can be removed from contact from the breast while the biopsy needle remains inserted in the breast.

According to a variant of the invention, the needle alignment guide is detachably mounted on the pressing frame.

According to a variant of the invention, the scanner probe securing means comprises a rotatable mounting arranged such that, when a scanner probe is secured in the rotatable mounting, the scanner probe is rotatable about an axis substantially perpendicular to the scanning plane.

According to a variant of the invention, the scanner probe securing means comprises probe height adjustment means for enabling adjustment of the distance between the scanner probe and the pressing frame.

According to a variant of the invention the pressure frame has a substantially U-shaped or V-shaped form. The lateral pressing elements can be formed as the sides of the U-shape or V-shape, and the backstop pressing element is formed as the arc of the U-shape or the vertex of the V-shape.

According to a variant of the invention, one or more of the lateral pressing elements or the backstop pressing element is 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.

According to a variant of the invention, one or more of the lateral pressing elements or the backstop 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.

According to a variant of the invention, the scanner probe and the support tool are integrated into one construction.

According to a variant of the invention, the scanner probe securing means comprise adjustable and/or elastic probe clamping means.

According to a variant of the invention, the probe clamping means comprise two or more opposed friction pads configured to be urged adjustably or elastically towards each other on either side of the scanner probe. According to a variant of the invention, the probe securing means and/or the pressing frame comprise adjustment means for adjusting the position and/or orientation of the scanner probe with respect to the pressure frame.

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, overlying a firm body substructure, hereafter referred to as the thoracic cage, the method comprising: a first step of 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, a fifth step, performed during the third and/or fourth steps, of, using a hand-held biopsy support tool as described above, manipulating the pressure frame of the hand-held biopsy support tool against the outer surface of the breast so as to restrain the lesion in a holding region of breast tissue between the pressure frame and the thoracic cage, whereby the pressing frame is pressed against the breast such that lateral pressing elements of the pressing frame press the breast on opposite sides of the lesion such that each of the lateral pressing elements urges the lesion towards the other, thereby urging the lesion into a holding region in a scanning plane substantially equidistant between the two lateral pressing elements.

According to a further variant of the method of the invention, 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, and the fifth step includes aligning the scanning zone of the scanning probe with the holding region. According to a further variant of the method of the invention, the method includes a setup step of adjusting the probe securing means of the hand-held biopsy support tool such that the target zone of the scanner probe is aligned with the holding region of the pressing frame so as to permit the pressing frame 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 probe securing means of the hand-held biopsy support tool.

The invention will now be described with reference to the attached drawings, in which:

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 hand-held biopsy support 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 hand-held biopsy support tool of figure 4 can be used in a minimally invasive biopsy procedure.

Figures 9 and 10 show an example of a scanner probe clamping device according to a variant of the invention.

Figures 1 1 and 12 show the scanner probe clamping variant of figures 9 and 10, with a detachable needle alignment guide.

Figure 13 shows a second type of needle alignment guide.

Figure 14 shows a third type of needle alignment guide. Note that the drawings are provided for explanatory purposes only, and are intended merely to indicate an example of how the invention can be realized. The drawings should not be taken as limiting the scope of protection, which is set out in the accompanying claims. The use of the same reference numbers in different drawings is intended to indicate that the references refer to the same features.

Figure 1 shows an example of a device according to an embodiment of the invention. The device comprises a U-shaped pressure frame 3, 4, 5 having two side arms (lateral pressing elements) 3 and 4 and an end part (distal, or backstop 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 or tube, 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 pressing frame 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 pressing frame into position and press the pressing frame 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 pressing frame 1 of figure 1 can be pressed against the breast 10 of a patient containing a lesion 2. By pressing the (in this case three) pressing elements 3, 4 and 5 against the breast, 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 14 left open for the purpose. Note that, in the example shown, the aperture 14 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

approaching needle. The combined urging forces on the lesion of the three pressing elements 3, 4 and 5 (and the reactive force of the body structures, such as the rib-cage, below the breast), 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. Thus 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 hand-held biopsy support 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. In the illustrated example, the scanning probe holder 7 is shown shaped to accept a particular type of ultrasonic scanning probe 20 having an oval cross section. However, other scanning probes have different forms and would require differently-shaped holders 7. Alternatively, a holder 7 could be attached which is designed to accept multiple types of scanning probe. Similarly, 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 pressing frame such that the probe is kept steady relative to the various elements of the pressing frame.

Figures 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 pressing frame 3, 4, 5 is shaped such that, when pressed into the soft tissue of the breast 10 over the lesion 2 within, the lateral pressing arms 3 and 4 limit the lateral movement of the lesion 2 between the two lateral arms 3 and 4 in a direction substantially orthogonal to the two lateral arms 3 and 4. The end, or backstop, element 5 limits the movement of the lesion 2 in the axial direction (i.e. a direction parallel to the lateral arms 3 and 4, to a principal axis of the pressing frame 3, 4, 5 and/or in the plane of insertion of the biopsy needle 1 1 ). In the example shown in figures 4 to 8, 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 comprises a mid-portion, which is raised slightly and therefore exerts less pressure on the breast 10, and two end portions, which are lower than the mid portion and therefore exert a relatively larger pressure on the breast when the pressing frame 1 is pressed on to the breast 10. This curvature of the lateral parts 3, 4 also helps to exert unequal forces on the lesion such that the lesion is urged approximately into the middle of a holding region defined by the four end points of the side elements 3, 4. Side elements 3 and 4 are shown approximately parallel, but they could also be arranged at an angle to each other and still achieve the objective of the invention. The pressing frame 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 pressing frame 3, 4, 5 is pressed against the breast 10 over the lesion 2. The pressing frame 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 pressing frame 3, 4, 5 can be varied to meet various requirements including patient comfort, the size or softness of the breast 10, the size or firmness of the lesion 2, the depth of the lesion 2 below the surface of the skin, or the individual preferences of the operator. 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 pressing frame 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 figures 4-8 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 pressing frame 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. In this case, 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). Alternatively, any conventional clamping or fastening means may be provided. In particular, 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 pressing frame 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.

Figures 9 and 10 show an example of an alternative embodiment of the hand-held biopsy support tool, which comprises an adjustable clamping arrangement for holding the scanner probe 20. Adjusting arms 42 operate with a scissor action to bring clamping pads 41 into pressure contact with the scanner probe 20. Pads 41 may advantageously be lined with, or made from, an elastomeric material to give an improved grip on the scanner probe 20. The scissor action of arms 42 can be actuated by an urging means such as a knurled wheel 43, or a spring, which urges the lower ends of the arms 42 apart, thereby exerting a closing force on the upper ends of the scissor arms 42, thus bringing the pads 41 into firm frictional contact with the scanner probe 20.

The hand-held biopsy support device may also be provided with a needle alignment means 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 pressing frame 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 pressing frame 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.

Figure 1 1 , for example, illustrates the same arrangement depicted in figures 8 and 9, with the addition of detachable needle alignment guide 50. The example needle alignment guide 50 is shown with fitting attachments - in this example the fitting attachments are implemented as tubular sections 51 which fit over the ends of pressing arms 3 and 4, and hold the needle guide 52 in the central scanning plane, which is equidistant from the arms 3 and 4. Alignment guide 52 is rotatable about cross-member 53, thereby making it possible to adjust the angle of needle 1 1 in the scanning plane. The alignment guide 52 comprises a rotatable element with an aperture through which the needle 1 1 can pass. Figure 12 shows the same arrangement as figure 10, but with the needle alignment guide fitted to the ends of the pressing frame arms 3 and 4.

Figure 13 shows a second variant of the needle alignment guide, 55, comprising two alignment openings through which the needle 1 1 can pass, and which keep the needle aligned with the scanning plane. A first alignment opening is formed from first guide side members 58, which are connected by first bridging member 54. A second alignment opening is formed from second guide side members 57. The first and second alignement openings are mutually aligned with the scanning plane such that needle 1 1 is retained in the scanning plane, while remaining mobile vertically, horizontally and rotationally within the scanning plane.

Figure 14 shows a third variant of the needle alignment guide which is essentially the same as the variant depicted in figure 13, but in which the first alignment opening does not have bridging member 54. The advantage of this embodiment is that the pressing frame 3, 4, 5, and the needle alignment guide 51 , 57, 58 can be removed from contact with the breast while the needle 1 1 remains inserted in the breast.

The devices illustrated in the figures allow 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. By moving the surgical holding device 1 , 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 . In a further variant, the scanning probe 20, and/or the ultrasound system to which the probe 20 is attached, may be 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.

The particular examples and embodiments in this description are given for the purposes of explanation, and are not intended to limit the scope of the definition of the invention, which is set out in the following claims.

Claims

1 . Hand-held biopsy support tool (1 ) for limiting movement of a predetermined target tissue structure (2), hereafter referred to as the lesion, within a body of soft, mobile tissue (10), hereafter referred to as the breast, overlying a firm substructure, hereafter referred to as the thoracic cage, such that the lesion (2) is restrained for sampling by a biopsy needle (1 1 , 12) while using a scanning probe to locate the lesion and monitor the sampling, the hand-held biopsy support tool (1 ) being continuously manipulatable using one hand to interactively scan, locate and restrain the lesion (2) during a biopsy operation, the hand-held biopsy support tool (1 ) comprising: a substantially rigid pressure frame (3, 4, 5) shaped for pressing the breast tissue (10) against the thoracic cage, in continuously manipulatable fashion using the one hand, so as to interactively manually restrain the lesion (2) between the pressure frame and the thoracic cage during the biopsy operation, a needle-insertion aperture (14, 52, 57, 58) through which a biopsy needle (1 1 , 12) can be inserted into a needle entry point of the breast (10) while the pressure frame (3, 4, 5) is pressed on to the breast (10) over the lesion (2), scanner probe securing means (6, 7, 8, 41 , 42, 43) for securing the scanner probe (20) to the pressure frame (3, 4, 5) such that orientation and/or position of the scanner probe (20) relative to the breast tissue (10) can be continuously manipulated, using the same one hand, during the biopsy operation, the pressure frame (3, 4, 5) comprising two lateral pressing elements (3, 4) for pressing against the breast (10) on opposite sides of the lesion (2) such that, when the pressing frame (3, 4, 5) is pressed on to the breast tissue (10) against the thoracic cage, each of the lateral pressing elements (3, 4) urges the lesion (2) towards the other (3, 4), thereby urging the lesion (2) into a holding region in a scanning plane substantially equidistant between the two lateral pressing elements (3, 4), the pressure frame (3, 4, 5) further comprising a backstop pressing element (5) fixed in a substantially rigid, mutually cooperating configuration with the lateral pressing elements (3, 4) such that, when the pressure frame (3, 4, 5) is pressed on to the breast tissue (10) over the lesion (2), the terminal pressing element (5) compresses the tissue of the breast (10) against the thoracic cage on a distal side of the lesion (2), away from the needle-insertion aperture (14), so as to urge the lesion (2) to resist an axial force exerted on the lesion (2) by the insertion of the biopsy needle (1 1 , 12).

2. Hand-held biopsy support tool (1 ) according to claim 1 , comprising a needle alignment guide (51 , 52, 54, 57, 58) for cooperating with a biopsy needle (1 1 , 12), for guiding the biopsy needle (1 1 ) in alignment with the holding region and/or the scanning plane.

3. Hand-held biopsy support tool (1 ) according to claim 1 or 2, wherein the pressing frame (3, 4, 5) and the needle-insertion aperture (14) and/or the needle alignment guide (54, 57, 58) are formed such that the pressing frame (3, 4, 5) can be removed from contact from the breast (10) while the biopsy needle (1 1 , 12) remains inserted in the breast (10).

4. Hand-held biopsy support tool (1 ) according to claim 2 or claim 3, wherein the needle alignment guide (51 , 52, 54, 57, 58) is detachably mounted on the pressing frame (3, 4, 5).

5. Hand-held biopsy support tool (1 ) according to one of claims 1 to 4, wherein the scanner probe securing means (6, 7, 8, 41 , 42, 43) comprises a rotatable mounting arranged such that, when a scanner probe (20) is secured by the rotatable mounting, the scanner probe (20) is rotatable about an axis substantially perpendicular to the scanning plane.

6. Hand-held biopsy support tool (1 ) according to one of claims 1 to 4, wherein the scanner probe securing means (6, 7, 8, 41 , 42, 43) comprises probe height adjustment means (8) for enabling adjustment of the distance between the scanner probe (20) and the pressing frame (3, 4, 5).

7. Hand-held biopsy support tool (1 ) according to one of the preceding claims, in which the pressure frame (3, 4, 5) has a substantially U- shaped or V-shaped form, such that the lateral pressing elements (3, 4) are formed as the sides of the U-shape or V-shape and the backstop pressing element (5) is formed as the arc of the U-shape or the vertex of the V-shape.

8. Hand-held biopsy support tool (1 ) according to one of the preceding claims, in which one or more of the lateral pressing elements (3, 4) or the backstop pressing element (5) is shaped so as to present a substantially concave pressing face towards the thoracic cage, the or each said concave- faced pressing element (3, 4, 5) thereby having two end portions which exert greater pressure when pressing breast tissue (10) on to the thoracic cage (10) than the pressure exerted by a middle portion, located between the two end portions.

9. Hand-held biopsy support tool (1 ) according to one of the preceding claims, in which one or more of the lateral pressing elements (3, 4) or the backstop pressing element (5) is shaped so as to present a substantially convex pressing face towards the thoracic cage, the or each said convex-faced pressing element (3, 4, 5) thereby having a middle portion, located between two end portions, which exerts greater pressure when pressing breast tissue (10) on to the thoracic cage than the pressure exerted by the two end portions.

10. Hand-held biopsy support tool (1 ) according to one of the preceding claims, in which the scanner probe (20) and the hand-held biopsy support tool (3, 4, 5) are integrated into one construction.

1 1 . Hand-held biopsy support tool (1 ) according to one of the preceding claims, the scanner probe securing means (6, 7, 8, 41 , 42, 43) comprising adjustable and/or elastic probe clamping means (41 , 42, 43).

12. Hand-held biopsy support tool (1 ) according to claim 1 1 , the probe clamping means (6, 7, 8) comprising two or more opposed friction pads (41 ) configured to be urged adjustably or elastically towards each other on either side of the scanner probe (20).

13. Hand-held biopsy support tool according to one of claims 2 to 12, in which the probe securing means (6, 7, 8) and/or the holding part comprises adjustment means (8) for adjusting the position and/or orientation of the scanner probe (20) with respect to the pressure frame (3, 4, 5).

14. Minimally invasive method of removing a portion of a

predetermined target tissue structure (2), hereafter referred to as the lesion, within a body of soft tissue (10), hereafter referred to as the breast, overlying a firm body substructure, hereafter referred to as the thoracic cage, the method comprising: a first step of locating the lesion in the breast (10), a second step of inserting a biopsy needle (1 1 , 12) into the breast

(10), a third step of guiding the biopsy needle (1 1 , 12) towards the lesion

(2), a fourth step of using the biopsy needle (1 1 , 12) to remove at least a portion of the lesion (2), the method being characterized by a fifth step, performed during the third and/or fourth steps, of, using a hand-held biopsy support tool (1 ) according to one of claims 1 to 13,

manipulating the pressure frame (3, 4, 5) of the hand-held biopsy support tool (1 ) against the outer surface of the breast (10) so as to restrain the lesion (2) in a holding region of breast tissue between the pressure frame (3, 4, 5) and the thoracic cage, whereby the pressing frame is pressed against the breast (10) such that lateral pressing elements (3, 4) of the pressing frame (3, 4, 5) press the breast on opposite sides of the lesion (2) such that each of the lateral pressing elements (3, 4) urges the lesion (2) towards the other (3, 4), thereby urging the lesion (2) into a holding region in a scanning plane substantially equidistant between the two lateral pressing elements (3, 4).

15. Method according to claim 14, in which: the first step includes using a scanning probe (20) to locate the lesion (2), the scanning probe (20) being secured to the pressing frame (3, 4, 5), and manipulating the scanning probe (20) and the pressing frame (3, 4, 5) together with one hand, the third step includes using scanning information provided by the scanning probe (20) to guide the biopsy needle (1 1 , 12) towards the lesion (2), the fifth step includes aligning the scanning zone of the scanning probe (20) with the holding region at the same time as restraining the lesion (2).