DK176453B1 - Ultrasound probe is for cavity scanning of object and comprises rectangular bar-shaped component with first longitudinal axis which at one end houses first transducer - Google Patents

Abstract

The ultrasound probe is for cavity scanning of an object and comprises a rectangular bar-shaped component with a first longitudinal axis which at one end houses a first transducer. The first transducer has a view field, which is established with the creation of an image along radial scanning lines in a first image plane, which coincides with the first longitudinal axis. The view field covers more than 15 degrees of scanning lines to each side where they cut the longitudinal axis and more than 15 degrees of scanning lines to each side where they cut the cross axis, which is located in the first image plane and at right-anvles to the longitudinal alxis. The probe can incorporate a first and second needle guide, which leads the instrument to a path which intersectsd the first view field.

Description

DK 176453 B1

ultrasound probe

The present invention relates to an ultrasonic probe.

5 Wallpaper

Various ultrasound techniques and devices have been developed for imaging the body's interior, e.g. the human body. One use of ultrasound imaging is in the medical field, and in particular endocavitary probes 10 (e.g., endocavitary probes for biopsy control). Such probes may e.g. used for endovaginal examination (eg for examination of uterus, ovaries, etc.), endorectal examination (eg for examination of wall of rectum, prostate, etc.) and / or other medical related uses . It should be noted that e.g. endorectal examination is quite uncomfortable and biopsy is quite painful and therefore typically requires local anesthesia. Typically, endocavitary probes comprise a linear array transducer disposed at the distal end or anterior end of the probe to be inserted into a body cavity. The transducer provides an image plane for displaying structures / features of the body and / or other instrument (e.g., a biopsy needle) such as e.g. can be introduced into the body via the probe. The image plane can be provided at one side of a probe (corresponding to a "side-four" transducer) or at the front of the probe (corresponding to an "end-four" transducer).

Endocavitary probes typically have an elongated rod-like shape with a handle extending as part of the elongated rod-like shape, but at the opposite end of the distal end. Unlike endocavitary probes, other ultrasound probes are designed to place the probe on the skin of the body to provide imaging of the body's interior which is beneath the skin. Still other probes (e.g., intraoperative probes) are designed to have the probe placed directly on organs within the body during surgical procedures.

2 DK 176453 B1 When ultrasonic probes are used for imaging purposes, they are connected to an image processor, e.g. in the form of a computer specifically for the purpose. The image processor is designed to provide the probe with stimulation signals for transmitting ultrasonic pulses and to record reflected ultrasound signals in response. Recorded ultrasound signals are processed to provide a presentation of the reflected ultrasound signals in the form of an ultrasound image on a screen display screen, e.g. a computer monitor.

10 Using an ultrasound probe for imaging purposes is also referred to as ultrasound scanning or simply scanning. Scanning is commonly understood as the act of systematically emitting a (finely focused) beam of e.g. ultrasound in a medium at various locations above the medium to produce an image of structures contained within the medium. The rays are emitted systematically, e.g. of transducer elements arranged in linear or curved linear transducer array. An image is formed from reflections received in response to emitted ultrasound rays.

The probe's transducer (s) has a so-called field of view, which is the section (usually in the form of a circular section) from which reflections are recorded and displayed as an image. The field of view is also called the plane of view, as the field of view can be perceived as a very thin section of a slice. A very thin section is desired to provide accurate spatial location (eg, organs or tumors). This is achieved by focusing the emitted ultrasonic waves in a direction across the linear array. Thus, the slice can be described as a circle plane or slice, but it will have a given thickness. The width of the field of view is determined by the length of the linear array and the shape of the array. Typically, the array is shaped to extend along an arc or circle. The depth of the field of view is determined, among other things. of the length of a time window that reflected 30 ultrasound signals is recorded within.

3 DK 176453 B1

Typically, the focusing required to achieve the desired field of vision across the length of the array is achieved by giving each of the transducer elements a concave surface shape (in the direction across the length of the array).

It is also desired to provide fine focusing in the image plane, i.e. in a direction 5 along the length of the array. This is typically accomplished by giving each of the transducer elements a flat surface shape (across the length of the array) and then achieving a desired focusing electronically. The focused image obtained from the field of view comprises a number of radial lines. The number of radial lines in the image corresponds to radial scan lines (in the scanned tissue) along which the focusing is provided. Thus, the field of view includes a number of scan lines.

The probe typically provides either signals from a single transducer array for display as a single image or, rather, sequences of images representing the ultrasound imaging from the field of view of the single transducer array. Some ultrasound probes include two arrays perpendicular to each other to provide biplane imaging, which are two separate images derived from the two different arrays. Thereby, a so-called sagittal image plane and transverse image plane can be provided for simultaneous viewing. The biplan-20 imaging provides more spatial information as a result of obtaining two images from two transducers with different fields of view.

For the vast majority of applications for endocavitary probes, the probe is used to monitor the safe control of an instrument, e.g. a biopsy.

This monitoring is typically performed by means of a probe formed with a guide which guides the instrument along a predefined path. The probe transducer) and the guide are positioned relative to each other so that they remain firmly positioned relative to each other and so as to obtain a field of view covering at least a portion of the predefined path which the instrument is guided. ad. This enables safe control of an instrument.

4 DK 176453 B1

The observations and techniques described above are well known in the art related to ultrasound probes. Reference is made to various endocavitary probes below.

5 Related Prior Art JP 02071732-A discloses an oblong ultrasound probe for biplane ultrasound imaging of a prostate. The elongate probe comprises an end portion with a longitudinal transducer array for sagittal imaging and a transversely transverse imaging transducer array where the longitudinally arranged array is perpendicular to the transverse array but at the more distal end of the end portion so that the image planes of the two transducers intersect orthogonally. The arrays are formed in a convex arc shape, thereby providing image guide planes from radial scan lines. The arc shapes have a relatively smooth shape.

The ultrasonic probe is described as being associated with a guide for a biopsy needle designed to guide a longitudinal biopsy needle relative to the elongated ultrasound probe, but displaced a distance from the probe. The guide for the biopsy needle is designed such that the biopsy needle is passed through the aperture in the body cavity and penetrates the body from the interior of the body cavity.

US 6,443,902-B1 discloses an ultrasonic probe with a removable needle guide for collecting tissue samples. The ultrasonic probe is designed to be inserted into a body cavity and comprises two transducer arrays and a needle control unit to guide a biopsy needle. The transducer arrays are arranged at right angles to each other as described above so as to provide biplane imaging.

30 The needle control unit is separate from, but may be connected to, the ultrasonic probe. The ultrasonic probe may be covered with a soft sleeve, and the needle guide may then be attached to the probe, but in such a manner that the sleeve prevents contact between the probe and the device. Thus, the needle guide is placed outside the sheath in such a way that a needle in the needle guide does not necessarily penetrate the sheath. Thus, only the device, but not the 5 probe, must be sterilized after use. The needle guide is arranged to guide the needle in a direction transverse to a longitudinal axis of the elongated ultrasound probe. The biop sinus guide is designed such that the biopsy needle is passed through the aperture in the body cavity and penetrates the body from within the body cavity.

US 6,261,234-B1 discloses a probe for providing simultaneous display of an instrument in two ultrasonic imaging plans (biplane instrument control). The probe is designed as an elongate member with an end portion designed to accommodate two transducer arrays. The two transducer arrays are in the form of a "side-four" transducer array and "end-four" transducer array disposed along a respective convex arc shape to provide two image planes. The two picture planes intersect at a line that coincides with an instrument path. A needle guide in the form of a groove in the probe is arranged to guide the needle along the instrument path as it is pulled from the groove.

In view of the end portion, the transducer arrays are arranged in L-shaped arrangement, with the groove having an opening from which the needle is pulled, at the corner of the L-shape.

Although the above documents describe important improvements, the retrieved documents describing the prior art do not fully utilize the patient comfort and efficacy / performance capabilities in medical diagnostic situations.

BRIEF DESCRIPTION OF THE INVENTION An ultrasonic probe for cavity scanning of a body is provided which comprises: an elongate member having a longitudinal axis and an end portion formed to accommodate a first transducer. The first transducer has a field of view established by obtaining an image along radial scan lines in a first image plane coinciding with the longitudinal axis. The field of view covers more than 15 degrees of scanning lines on each side of its intersection of the 5 longitudinal axis and more than 15 degrees of scanning lines on each side of its intersection on a cross axis located in the first image plane perpendicular to the longitudinal axis.

Accordingly, the probe can be used for two different scanning principles in a sagittal image plane: "end-four" scanning and "side-four" scanning. This greatly increases the use of the probe, with each of these scanning principles having its own advantages. Because one and the same probe can be used for the two different scanning principles, the probe operator can use the same probe for both types of scans. The operator does not need to switch between two different probes.

In doing so, the patient is subjected to less complicated endocavitic examination and the discomfort experienced by the patient is thereby reduced. In addition, the efficiency and performance of medical examination situations are significantly increased as a result of the less complicated endo-cavitary examination.

20

The probe also provides improvements to instrument control. When used in combination with instrument control, the two above-mentioned scanning principles allow biopsies to be taken and monitored along two different paths, while the probe remains in the body cavity. The two different paths will run through different locations in the body, thus allowing monitored biopsies to be taken at multiple sites in the same operating cycle, ie. the operating cycle in which the probe is and remains in the body cavity.

Conveniently, the first transducer and / or the second transducer has a field of view which is centered around the respective longitudinal axis and / or transverse axis. In this way, the field of vision provided by the probe is placed more intuitively approx. zero degrees and / or ninety degrees relative to the longitudinal axis of the often rod-shaped probe.

The field of view on each side of its intersection on the longitudinal axis or transverse axis preferably covers a radial section larger than an angle selected from the group consisting of 20, 25, 30, 35, 40, 45, 50 and 55 degrees.

The maximum size of the angular coverage of the field of view is determined by the shape and length of the transducer array. With the size of the field of view 10 providing image data can be reduced electronically as desired. For larger radial sections around the longitudinal and transverse axes, the radial sections may overlap.

When the field of view established around the longitudinal axis and the field of view established around the transverse axis are of substantially the same size, the respective images obtained may conveniently occupy the same field on a screen display. Thereby, switching between the two images intuitively will cause less confusion.

According to a preferred embodiment, the ultrasonic transducer further comprises a second transducer array which provides a field of view in a second image plane transverse to the longitudinal axis of the elongate element. This results in a great improvement in the spatial imaging capacity as the second image plane proceeds in a further (third) dimension relative to the two dimensions of the first image plane. This biplane imaging capability is conveniently used to provide image data from the second transducer and a portion of the first transducer which covers a section around the transverse axis.

Conveniently, the second transducer array is inclined to provide 30 of the second image plane at an angle of less than 90 ° relative to the longitudinal direction towards one end of the elongate member. Thereby, a section of the first image plane about the transverse axis and the second image plane can be arranged to coincide. Thereby, e.g. an instrument is placed in both picture planes to provide improved spatial placement.

Preferably, the second transducer is inclined to provide the first image plane at an angle within the range of 40 to 110 degrees with respect to the longitudinal axis towards one end of the elongate member. A slope of approx. 70-80 °, e.g. 85 °, has been found to be particularly convenient.

10

Conveniently, the first transducer is disposed on the more distal portion of the end than the second transducer array. Thereby, the first transducer can provide "end-four" imaging without the "end-four" field of view colliding with the structure of the second transducer.

15

In one embodiment, the ultrasonic transducer is configured to allow selection of: a first mode, where an end view image is obtained from a first portion of the first transducer array, with a field of view covering scan lines at each side of the longitudinal axis, and a second mode , where a side view image is obtained from an end portion of the first transducer array with a field of view covering scan lines at each side of the transverse axis.

The first and second portions of the first transducer array have a field of view which covers a first and a second section of beam scan lines; and wherein the first and second slices are arranged to cover a common slice of scan lines. Thereby, the first transducer is used more efficiently in that the elements of the first transducer forming the common or overlapping sections are used in both images corresponding to both sectors. Accordingly, the same transducer line array can be used to obtain both images.

30 9 DK 176453 B1 In addition, when a transverse image is obtained in a different mode, but from the second transducer array, two different and recognized principles for prostate scanning are provided: biplane scanning in the second mode and "end-of-four" scanning in the first mode. The bi-plane scan includes the “page-four” -5 scan and the scan in the transverse image plane.

When the first transducer array covers an output of e.g. more than 160 degrees, there will typically be more transducer elements in the linear array present than pins on a sensible electrical connector. Thus, on the one hand, pure parallel reading of the individual transducer elements is excluded. On the other hand, very few pins would not provide readout for all transducer elements within a reasonable time frame. Therefore, the probe is conveniently designed with a multiplexer for combined parallel and time-multiplexed output of image data.

15

Preferably, the probe is configured with coupling means for coupling with a biopsy unit with complementary coupling means. Thereby, the probe can be independently protected by a cover to prevent sterilization of the probe between each use of the probe. The coupling agents and the probe biopsy unit should allow sufficient illumination to allow the cover to protect the probe without being punctured or damaged.

The probe or biopsy unit comprises a first needle guide which is designed to guide a needle along a path intersecting the first field of view, and a second needle guide 25 which is designed to guide a needle along a path intersecting the first field of view and transverse axis. This allows the instrument (eg a needle) to be guided safely as it can be monitored along its path.

A known configuration comprises a biopsy needle guide for guiding a needle along a web 30 toward, but displaced relative to, a rod-shaped probe, and a "side-four" monitoring of the web (cf. US 6,443,902). B1, Fig. 1) This configuration, however, presents problems when used to extract biopsies from a prostate, for example a biopsy procedure may comprise at least two biopsies from the apical region of the prostate (closest to the pelvic floor muscle). In that situation, the biopsy needle will first penetrate the human tissue a short, but sometimes 5, significant distance behind the sagittal imaging projected from the first transducer. Examining the anatomy slightly below the apex identifies the various pelvic floor muscles more clearly. Any attempt to insert a biopsy needle along, but displaced relative to the probe, will bring the needle close to - or even pass through - through portions of the muscle.

Therefore, the first needle guide is conveniently arranged to guide a needle in a direction across the longitudinal axis, and the second needle guide is arranged to guide the needle towards the elongate member.

15

The biopsy needle guided in the transverse direction is thus passed through the aperture in the body cavity and penetrates the body from within the body cavity. Thus, the basal area (opposite to the apical region) of the prostate may be subjected to biopsy capture while simultaneously monitoring the "side-four" -20 imaging. The longitudinally directed biopsy needle is also passed through the aperture in the body cavity (very close to the periphery of the probe) and penetrates the body from inside the body cavity. Similarly, but rotated approx. 90 degrees and introduced into the body at a more acute angle, biopsies can be taken from the apical region of the prostate while simultaneously monitoring 25 "end-four" imaging. This allows biopsies of both apex and the base of the prostate to be made in the same cycle operation while simultaneously monitoring either "side-four" or "end-four" imaging.

The combination of the transversely directed biopsy needle and the longitudinally directed biopsy needle provides an excellent probe for taking biopsies of a prostate in a single cycle of operations.

11 DK 176453 B1

Preferably, the first needle guide is adapted to provide an angle between the needle as it is inserted into the needle guide and the longitudinal axis of the elongate member which is within the range of 10 to 50 degrees. The needle guide can be designed as a substantially straight tubular member or curved tubular member.

Preferably, the first needle guide provides an angle between a needle when inserted into the first needle guide, by its projection from the first needle guide and the longitudinal axis of the elongate member within the range of 10 to 50 degrees. The projection of the needle can be controlled with the needle guide to obtain the desired drawing angle.

Conveniently, the needle guides are arranged relative to the elongate member so that when inserted into the needle guides, the needles are pulled in opposite positions relative to a cross-section of the biopsy unit. Thereby, it is possible to address the sites of tissue sampling during the biopsy needle pathway study by first using the first needle guide to take first biopsies (remove the biopsy needle) and then simply rotate the probe to take other biopsies. This is more appropriate than actually changing the probe.

According to a preferred embodiment, the second needle guide extends along the periphery of the elongate member, but displaced relative to the periphery in the direction 25 away from the center of gravity seen in cross-section of the elongate member.

According to a preferred embodiment, the elongate member has a mold which is designed to be mechanically connected to a probe and to fit with a recess in a probe, thereby providing a combination of the unit and the probe as they are connected to the bar which may is surrounded by a cylinder covering 12 at least a portion of the length of the elongate member and having a diameter within the range of 12 to 30 millimeters.

The needle guides may be designed as a tubular member with an input end 5 designed for penetration of a needle and an output end designed for the needle to project from the needle guide. The smooth shape of the tubular member gives less tendency to collect dirt and tissue debris as there are fewer projections.

10 To reduce the risk of blending the obtained images together, biopsy needle guide markings may correspond to respective markings on obtained biplane images when displayed on a screen display.

Brief Description of the Drawing 15

Preferred embodiments will be described in more detail with reference to the drawings, in which:

FIG. 1 is a cross-sectional view of an ultrasonic probe comprising a transducer array having a field of view;

FIG. 2 is a cross-sectional view of an ultrasonic probe comprising a longitudinal needle guide and a longitudinal needle guide; FIG. 3 is a cross-sectional view of an ultrasonic probe comprising a needle guide arranged along the ultrasonic transducer but inclined;

FIG. 4 is a cross-sectional view of an ultrasound probe in a mode providing sagittal "side-four" imaging and transverse imaging; 30 13 DK 176453 B1

FIG. 5 is a cross-sectional view of an ultrasound probe in a mode providing sagittal "end-four" imaging;

FIG. 6 is a cross-sectional view of an ultrasound probe shown with different fields of view;

FIG. 7a-b show a side view and a top view of an ultrasound probe with a recess for recording a biopsy unit; FIG. 7c-d show a top view and side view of a biopsy unit;

Figure 7e shows coupled ultrasound probe and biopsy unit;

Fig. 7f shows an ultrasonic probe protected by a cover; 15

FIG. 7g shows a biopsy unit with a curved needle guide;

FIG. 8a and 9b show a side view and a 3D image of an ultrasonic probe in a biplane mode; 20

FIG. 9a and 9b show a side view and a 3D image of an ultrasonic probe in an "end-four" mode; and

FIG. 10a and 10b show a side view and a 3D image of a biopsy unit.

25

Description of a Preferred Embodiment In FIG. 1, an ultrasonic probe comprising a transducer array having a field of view is shown in cross section. The ultrasonic probe 100 is designed for cavity scanning of a body, in that it has an oblong or rod-like shape which can be inserted into the cavity. In general, such an ultrasound probe has a handle, a shaft! And a distal end configured to accommodate an ultrasonic transducer 104a; 104b.

Only the part of the shaft facing the distal end is shown - the handle does not appear. The distal end of the probe may also be termed a scanning head or the scanning end of the probe. The probe or rather the distal end thereof 5 can also be viewed as a housing, holding the transducer array. In general, the probe has the shape of an elongated element.

A longitudinal axis 102 of the probe or elongate member is shown as a dotted line. A transverse axis 103 perpendicular to the longitudinal axis 102 is also shown 10 as a dotted line.

In one aspect, the probe 100 is designed to accommodate at its distal end a first transducer in the form of two separate arrays 104a; 104b of ultrasonic transducer elements. The two arrays 104a, 104b are spaced apart, but spaced apart in the extension direction. However, the offset distance may be so small that the arrays provide imaging equivalent to a single array. According to a further aspect, as further described below, the first transducer is in the form of a single array. The arrays or array provide an image plane that coincides with the longitudinal axis 102 and the transverse axis 103, that is, the axes lie in the image plane. For medical purposes, this imaging plane is also referred to as a sagittal imaging plane.

The transducer arrays 104a, 104b are designed to provide a desired field of view in the sagittal image plane. It is generally desired to use small (i.e.

Accordingly, the arrays are formed along a convex arc shape in order to emit and receive ultrasonic wave energy along radial scanning lines. The radial structure of the scan lines provides a circular section which widens with the distance to the transducer. The smaller the radius of the convex arc shape, the wider the circle section. The above is based on a circular arc shape. However, other arc shapes can be used which provide radial scan lines. Such other forms may comprise slices of straight linear arrays, each comprising a plurality of transducer elements. Complex arc shapes comprising slices with different radii can also be used to achieve a desired field of view.

While it is generally desired to achieve small illumination or close contact between the transducer and the housing at the distal end, the shape of the transducer dictates the shape of the housing around the transducer. In the configuration shown, the housing and transducer are shaped as part of a circular arc. As it is an object to provide a design of the probe suitable for cavity scanning and thus convenient for insertion into the cavity, the probe is provided with a recess 106 behind the housing housing the transducer arrays 104a, 104b. Thereby, the field of view 105a around the transverse axis 103 can extend further towards the end of the probe in which the handle is located without assuming a larger diameter of the housing.

15

The arrays 104a and 104b of the first transducer provide partial fields of view 105a and 105b, respectively. The field of view 105a, 105b provided by the first transducer 104a, 104b covers more than 15 degrees of scan lines on each side of where it intersects longitudinal axis 102, and more than 15 20 degrees of scan lines on each side of where it intersects a transverse axis 103. Thus the angles a1, a2, a3 and a4 look greater than 15 degrees. The angles need not be the same. According to preferred embodiments, a1 plus a2 is approximately equal to a3 plus a4.

25 For most practical purposes, a partial field of view of more than 30 degrees is desired. Thus, the field of view on each side of where it intersects the longitudinal axis or the transverse axis covers a radial section larger than an angle selected from the group consisting of 20, 25, 30, 35, 40, 45, 50 and 55 degrees.

It is also shown that the first transducer has partial fields of view centered around the longitudinal axis 102 and the transverse axis 103. It is also shown that the visual field 105b established around the longitudinal axis 102 and the visual field 105b established around the transverse axis 103, is of approximately the same size.

5 In FIG. 2 is a cross-sectional view of an ultrasound probe comprising a longitudinal needle guide and a needle guide located in the transverse direction. This placement of the needle guides improves the use of the ultrasound probe to be used to take biopsy specimens along two different biopsy pathways while providing safe monitoring of both pathways.

10

The transverse needle guide 203 and longitudinal needle guide 204 may, as shown, be integrated with probe body 101. Alternatively and as further described below, the probe may be configured with coupling means for coupling with a biopsy unit with complementary coupling means.

15

The probe body 101 comprises a first transverse needle guide 203 which is designed to guide a needle along a path 202 which intersects the field of view 105a established about the transverse axis 103. It further comprises a second longitudinal needle guide 204 which is configured to guiding a needle along a path 201 which intersects the field of view 105b established about the longitudinal axis 102. Thus, a needle or other instrument guided by the needle guide along one of the paths will cut at least some of the scan lines of the respective fields of view. and thus could be seen during the ultrasound scan. Thereby, secure monitoring of both lanes is provided.

25

The transverse needle guide 203 guides a needle along the path 202. This path intersects the scanning lines of the field of view 105a established about the transverse axis 103 at angles of e.g. between approx. 25 to 90 degrees. Thus, the path 202 can be seen over the entire field of view.

30 17 DK 176453 B1

The transverse needle guide is adapted to provide an angle between the needle when inserted into the needle guide and the longitudinal axis of the elongate member within the range of 10 to 50 degrees, preferably at about 10 degrees. 15 to 20 degrees, e.g. at 17 degrees.

In the case of a straight transverse needle guide, the same angle is provided along the entire web 202. However, a needle guide designed to provide a curved web can also be used. Such a curved guide may provide an angle between a needle when inserted into the first needle guide, by its projection from the first needle guide and the longitudinal axis of the elongate member which is within the range of 10 to 50 degrees.

The longitudinal needle guide 204 guides a needle along the path 201. This path intersects the scan lines of the field of view 105b established about the longitudinal axis 15 102 at angles of e.g. between 5 and 25 degrees. Thus, the web 201 can only be seen in a partial section of the field of view.

Viewed along the longitudinal axis 102 at a point which is more distal than the housing of the probe and towards the housing of the probe, the needle guides are positioned relative to the elongate member so that when inserted into the needle guides, the needles are pulled in opposite positions relative to a probe. cross section of the biopsy unit. Thus, e.g. a prostate is addressed by either of the lanes 201, 202 by rotating the probe 180 degrees about its longitudinal axis.

According to this embodiment, the first transducer is designed as a single array 104. Thereby, the signals to and from the elements of the transducer array can be selected electronically so as to provide different size or placement of images from the transducer array. This will be described in more detail later.

30 18 DK 176453 B1 In FIG. 3 is a cross-sectional view of an ultrasonic probe comprising a needle guide arranged along the ultrasonic transducer, but obliquely. In this embodiment, one of the needle guides 303 extends in a direction along the elongate member 101. This direction may be parallel to a longitudinal axis of the elongate probe or, as shown, oblique to a longitudinal axis of the elongate probe. This inclination is preferably arranged such that the web 302 crosses the longitudinal axis in front of the transducer 104. The needle guide 303 can be configured as a straight channel or a curved channel. Thus, the slope need not be present - or be the same - along the entire extent of the guide 303.

10 In FIG. 4 is a cross-sectional view of an ultrasound probe in a mode providing biplane imaging. Biplane imaging is provided by sagittal "side-four" imaging and transverse imaging. The transverse imaging is provided with a second transducer array 405 to provide a second imaging plane 406 across the longitudinal axis of the elongate element. Preferably, the second imaging plane is 406. orthogonal to the first image plane 407. The second image plane is also called the transverse image plane.

The transverse image plane 406 may be arranged so as to coincide with the axis 103 transversely of (perpendicular to) the longitudinal axis 102, i. at right angles or approximately at right angles. However, as shown, it is preferred that the second transducer array be inclined to provide the transverse image plane at an angle of less than 90 degrees with respect to the longitudinal axis in direction 25 towards the distal end of the elongate member. The transverse image plane 406 is shown at an angle of approx. (180 degrees minus 107 degrees equals) 73 degrees relative to longitudinal axis 102. Preferably, the second transducer is inclined to provide the second image plane at an angle which is within the range of 40 to 85 degrees relative to the longitudinal axis towards it. one end of the 30-long element.

19 DK 176453 B1

As the second transducer 405 is positioned at an oblique position with respect to the first transducer 104, the image plane 406 provided by the second transducer will intersect the field of view provided by the first transducer.

As there are certain spatial locations in both image planes, the ability provided by the second image plane 406 to scan outside the sagittal image pan 407 can thereby improve spatial location determination. As will be seen, the transverse field of view will only cut scan lines in a section of the first field of view, ie. a partial section of the first field of view.

As will be seen, the first transducer 104 is disposed at one end of the elongate member 101 but at the more distal portion of the end relative to the second transducer array 405.

It is also shown that only a portion (i.e., a 131.7 degree cut closest to the transverse array 405) of the first transducer 104 is used to provide the sagittal field of view, i.e. the portion enclosed by the field of view 407. The remaining portion of the first transducer 104 may or may not be used when the probe is in a mode in which biplane imaging is provided.

20

According to this embodiment, the transverse needle guide comprises a channel 203 extending at its distal end into a projection 404. The longitudinal needle guide comprises a channel 401 extending at its distal end into a projection 402. An instrument, e.g. needle, follows path 403.

25

Preferably, the distal opening of the channel 203 is positioned relative to (the left side boundary of) field of view 407. Thus, the web 202 can be monitored / scanned as the needle begins to pull from the opening of the channel 203 and potentially cause tissue or organ damage. a body.

30 20 DK 176453 B1

The angle b indicates the slope of the transverse field of view 406 relative to the left border of the (sagittal) image plane (407). The angle c indicates the coverage of the (sagittal) field of view 407. The angle d indicates the angle between the longitudinal axis and the left border of the (sagittal) image plane (407).

5 In FIG. Figure 5 is a cross-sectional view of an ultrasonic probe in a mode providing sagittal "end-four" imaging. In this mode, a second portion of the first transducer array is used to obtain the image (image signals). " The four "image is provided from a field of view corresponding to a circular section of about 140 degrees. The field of view 501 is substantially centered about a longitudinal axis 102 of the probe 101. However, this centering may differ by about +4 degrees, with the elements of the array may be arranged so that perfect centering is inappropriate The angle e indicates the coverage of the sagittal "end-four" view 501.

15

The probe can be operated in one of two modes: a mode providing "side-four" imaging or bi-planar imaging comprising "side-four" imaging, and another mode providing "end-four" imaging. Preferably, the probe is designed to allow selection of a first mode in which an end display image is obtained from a first portion of the first transducer array with a field of view covering scan lines on each side of the longitudinal axis. It is possible to switch to a different mode, where a side view image is obtained from a second part of the first transducer array, with a field of view covering scan lines on each side of the transverse axis. In the second mode 25, the transverse image is also obtained. The modes can be selected either by operating one or more buttons on the probe or by the imaging console.

In FIG. 6, an ultrasonic transducer shown with different fields of vision is shown in cross section. Four different visual fields are shown in the sagittal image plane, which can be reached by the first transducer. Two “end-four” fields of view and two “side-fours” fields of view are displayed.

A first "end-four" view 601 has a wider angular coverage than a second 5 "end-four" view 602. The first "end-four" view 601 covers a circular section of approx. 132 degrees. The second "end-four" view 602 covers a circular section of approx. 84 degrees.

A first "side-four" view 604 has a wider angle coverage than a second 10 "side-four" view 603. The first "side-four" view 604 covers a circular section of about 90 degrees. The second "than "four" view 602 covers a circular section of about 132 degrees.

The second "end-four" view 602 and the second "side-four" view 603 are juxtaposed and in combination have non-overlapping coverage. If these "side-four" and "end-four" views constitute the desired views for all uses of the probe, the first array 104 need not cover a larger field of view. However, these "side-four" and "end" -fire 'displays also represent electronically selected fields of view - larger -20 field of view provided by the first transducer.

The first "end-four" view 601 and the second "side-four" view 604 are arranged to establish a common field of view or overlap, which may be desirable in all cases because the common field of view improves the ability to maintain a reference location when switching from the side view to the end view, and vice versa, however, this may also be the case because the field of view provided by the first transducer array is of limited length. of scan lines.

30 22 DK 176453 B1

The angle f indicates the angle between the longitudinal axis and the left lateral boundary of the (sagittate) field of view 602, and the angle g indicates the angle between the longitudinal axis on the left in view 601. The angle h indicates the coverage rejection 601.

The probe will typically comprise electronic circuits designed with a multiplexer for a combined parallel and time-multiplexed output of image data.

Figures 7a-b show a side view and a top view of an ultrasound probe with a recess for recording a biopsy unit. In this embodiment, the biopsy unit comprises the needle guides and can be released from the ultrasonic probe 700. The probe comprises an elongated shaft 702 with a recess 703 and a distal end with a housing 701 for receiving the transducer arrays (not shown). The housing 701 (or the scanner head) forms part of the probe 700. As shown, the housing 701 has a cross-section that matches the cross-section of the shaft so that a probe is formed without sharp projections. The housing 701 has parts or windows 704, 705, behind which the transducer arrays are mounted. The windows are optimized for transmitting ultrasound between the transducers and the medium to be scanned surrounding the probe in use.

20 A recess or groove 715 provides an attachment opening for the unit.

In FIG. 7c-d, a top view and one side view of a biopsy unit are shown. The biopsy unit 706 comprises the needle guides and can be released from the ultrasound probe 25 700.

The biopsy unit 705 has an elongated member 707 having a cross section in the form of a half tube section (e.g., a semi-cylindrical member). This cross-section of the elongate member matches the recess 703 of the probe so that the unit is interconnected with the probe and a one interconnected probe and unit are formed which is relatively smooth and relatively closely interconnected so that larger slots or gaps between the probe and the device are avoided.

With a collar 708, attachment of the unit to the handle end 5 of the probe is provided. At the opposite end of the elongate member, a knob or pin 716, when engaged with the groove 715, provides locking of the unit at the distal end of the probe. Retention is further enhanced with an upper lip 709 and a lower lip 711 which engage with a portion of the periphery of the probe.

10

The upper lip 709 and lower lip 711 are formed with openings 710 and 718, from which instruments inserted into channels 717 and 712 can be pulled to follow the biopsy webs into the tissue being examined.

The needle guide 712 extends along the periphery of the elongate member 707, but displaced relative to the periphery in the direction away from the center of gravity seen in cross-section of the elongate member. This offset distance is only approx. a few millimeters or a fraction of a millimeter. As shown, this offset distance may vary along the length of the elongate member 707.

20

The ducts are made of a material that is resistant to sterilization and which is robust to damage caused by the introduction of a sharp instrument into the handle, e.g. High quality stainless steel. Channel 712 is held in position relative to the elongate member by means of a bracket 714.

25

The elongated member is made of a material that can withstand autoclaving.

The channels 717 and 712 end at the handle end of respective end pieces 719 and 720, which are shaped like a convex cylinder, so that the probe operator can place two fingers and safely (with one hand) hold the finger grip when the instrument or needle is to be inserted into the guide. . The end pieces may optionally have a tactile surface on a portion of the surface to make it easier to handle safely. Preferably, marking on the end pieces is similar to marking on the biplane images obtained by the first transducer in "side-four" or "end-four" modes, respectively, when displayed on a screen display.

5

FIG. Fig. 7e shows coupled ultrasonic probe and biopsy unit. It will be seen that collar 708 and upper lip 709 and lower lip 711 engage with the probe.

It will further be seen that the knob or pin 716 engages with the groove 715 to form a locking mechanism.

10 In FIG. Figure 7f shows an ultrasonic probe protected by a cover. The device is separate from the probe but appears next to the probe. The probe is covered by a cover 720 so that the probe is protected from direct contact with the patient when inserted into a body cavity. Thus, disinfection of the 15 probe after use becomes unnecessary. The probe is ready to be used next time after regular cleaning thereof (when the cover 720 is removed). Thus, the device 706 does not need to come into direct contact with the probe. This arrangement of the device is particularly advantageous in that a needle will not penetrate through the cover 720. As a result, the probe is not contaminated unnecessarily and thus does not need to be disinfected after each use.

In FIG. 7g shows a biopsy unit with a curved needle guide. In this embodiment, the transverse guide 721 is shown as a curved channel guide. In this way, the angle of drawing can be arranged with fewer restrictions than a straight channel. In particular, the handle end of the handlebars can be placed with fewer restrictions, allowing for a more ergonomic or operator-friendly design.

FIG. Figures 8a and 9b show a side view and a 3D image of an ultrasonic probe in a biplane mode. The probe comprises a handle 801 and a shaft 802 with a scan head 803. The handle has two knobs 805 for switching between the probe modes, e.g. can be selected with one of the buttons "end-four" mode and with the other biplane mode 25 DK 176453 B1. A cable connection 804 is provided at the handle end.

The probe is coupled to a biopsy unit by means of an elongate member 5 815 held together with the probe by a clamp 806. An upper lip 811, a lower lip 810, a longitudinal guide channel 809 and end pieces 808 thereof are also shown. In addition, an end piece 807 of a transverse guide is shown and the biopsy web 812 established by the transverse guide is also shown.

10

The probe is shown in a mode which provides bi-plane imaging with a so-called field of view 813 and a transverse field of view 814. The sagittal field of view 813 is adapted to provide primarily a "side-four" view.

FIG. 9a and 9b show a side view and a 3D image of an ultrasound probe in an "end-four" mode. The sagittal field of view 816 is designed to provide primarily an "end-four" view. The biopsy web 817 established by the transverse guide is also shown.

FIG. 10a and 10b show a side view and a 3D image of a biopsy unit. This unit is the biopsy unit shown coupled to the probe shown in FIG. 8 and 9, but shown here in more detail.

The biopsy unit 1000 has an elongated member 815. A collar 818 provides retention or retention of the device at the probe end handle.

At the opposite end of the elongate member, a knob or pin 817 provides for holding or holding the device at the distal end of the probe. The restraint is further enhanced by an upper lip 811 and a lower lip 810 which engage with a portion of the periphery of the probe.

30 26 DK 176453 B1

The upper lip 811 and lower lip 810 are formed with openings (not shown) from which instruments inserted into channels 816 and 809 can be drawn to follow the biopsy webs into the tissue under examination.

The needle guide 809 extends along the periphery of the elongate member 815 and is held in a fixed position at the handle end by a fastening projection 819. The needle guide 816 extends transverse to the longitudinal axis of the elongate member 815 and held in a fixed position at the handle end by a channel 820 in the elongate element 815. The channel 820 retains the guide by friction. At the opposite ends of the guides 816, 809, the guides are retained by the upper lip 811 and the lower lip 810.

The channels 816 and 809 terminate at the handle end of respective end pieces 807 and 808 which are configured as a convex cylinder so that the probe operator can place two fingers and safely (with one hand) hold the finger grip when the instrument or needle is to be inserted into the guide. . Preferably, the markings on the end pieces correspond to the markings on obtained biplane images, respectively, when displayed on a screen display. As shown, the end pieces may have different shapes externally, e.g. have an outside shape such as a concave cylinder (807) or an outside shape such as a combined cylinder and cone.

As indicated above, the field of view includes a number of scan lines. The image is focused along these scan lines, either by the physical shape of the transducer elements or electronically or by a combination of the two. When a combination of the two is used, the elements of the array may have a surface shape which is convex in a direction transverse to the length of the linear array and which is substantially equal in a direction longitudinal to the length of the array. .

30 As the array is curved, its transducer elements must have surface normals which extend mutually radially from the surfaces of the array elements or in it.

TEN

at least some of the elements must have surface normals that extend mutually radially from the surfaces of the array elements. It should be remembered that a surface normal to a flat surface is a three-dimensional vector perpendicular to the surface. A normal to a non-flat surface at a point on the surface is a vector perpendicular to the tangent plane with respect to surface at the point. The radial surface normals (not considering their length) of the transducer elements may coincide with the scanning lines, thus defining the field of view provided by the transducer array.

Although linear curved array embodiments have been described primarily, alternative embodiments may include curved multiline arrays (curved arrays of transducer elements). Other alternative embodiments may include element transducers, e.g. single element transducers arranged in mechanically moving configurations.

Claims (22)

An ultrasonic probe for cavity scanning of a body, comprising: an elongated member (101) having a longitudinal axis (102) configured to accommodate, at one end, a first transducer (104); wherein the first transducer (104) has a field of view (105) established by obtaining an image along radial lines (107) in a first image plane coincident with the longitudinal axis (102); wherein the field of view (105) covers more than 15 degrees to each side of where it intersects the longitudinal axis (102) and more than 15 degrees to each side of where it intersects the transverse axis (103) located in the first image plane and is the bell on the longitudinal axis (102), An ultrasonic transducer according to claim 1, wherein the first transducer (104) has a field of view centered around the longitudinal axis (102) and / or the transverse axis (103). 20 An ultrasonic transducer according to claim 1, wherein the field of view on each side of where it intersects the longitudinal axis (102) or the transverse axis (103) covers a radial section larger than an angle selected from the group consisting of 20, 25, 30, 35 , 40, 45, 50 and 55 degrees. 25 An ultrasonic transducer according to claim 1, wherein the field of view established about the longitudinal axis (102) and the field of view established around the transverse axis (103) are of approximately the same size. DK 176453 B1 29 The ultrasonic transducer of claim 1, further comprising a second transducer array (405) for providing a second image plane (406) transverse to a longitudinal axis of the elongate member (101). An ultrasonic transducer according to claim 1, wherein the second transducer array (405) is inclined to provide the second image plane (406) at an angle less than 90 degrees with respect to the longitudinal axis towards one end of the elongate element. An ultrasonic transducer according to claim 1, wherein the second transducer (405) is inclined to provide the second image plane at an angle which is within the range of 40 to 110 degrees relative to the longitudinal axis towards one end of the elongate element. The ultrasonic transducer of claim 1, wherein the first transducer (104) is disposed at one end of the elongate member (101) but at the more distal portion of the end than the second transducer (405). An ultrasonic transducer according to claim 1, wherein the ultrasonic transducer is designed to allow selection of: - a first mode, wherein an end display image is obtained from a first portion of the first transducer array (104) with a field of view (501) covering scan lines at each side of the longitudinal axis (102), and - a second mode obtaining a side view from a second portion () of the first transducer array (104) with a field of view (407) covering scan lines at each side of the transverse axis (103) ). An ultrasonic transducer according to claim 9, wherein the first and second portions of the first transducer array (104) have a field of view (601, 604) which covers a first 30 and a second portion of scan lines; and wherein the first and second slices are arranged to cover a common slice of scan lines. 30 DK 176453 B1 The ultrasonic transducer of claim 1, wherein a transverse image is also obtained in the second mode but from the second transducer (405). An ultrasonic transducer according to claim 1, configured with a multiplexer for a combined parallel and time multiplexed output of image data. An ultrasonic transducer according to claim 1, configured with coupling means (806; 810; 811,716, 715) for coupling with a biopsy unit (706). 10 An ultrasonic transducer according to claim 1, comprising: - a first needle guide (203) configured to guide a needle along a path (202) which intersects the first field of view (105) and the transverse axis (103); and - a second needle guide (303) configured to guide a needle along a path 15 (201,302) that intersects the first field of view (105). The biopsy unit of claim 14, wherein the first needle guide (203) is arranged to guide a needle in a direction transverse to the longitudinal axis; and 20. wherein said second needle guide (204; 303) is adapted to guide said needle longitudinally of said elongate member (101). The biopsy unit of claim 14, when the first needle guide is positioned such that an angle is provided between the needle as it is inserted into the needle guide and the longitudinal axis of the elongate member which is within the range of 10 to 50 degrees. The biopsy unit of claim 14, wherein the first needle guide provides an angle between a needle when inserted into the first needle guide, at its projection from the first needle guide, and the longitudinal axis of the elongate member which is within the range 10 to 50 degrees. DK 176453 B1 31 The biopsy unit of claim 14, wherein the needle guides (203, 204, 303) are positioned relative to the elongate member (101) so that when inserted into the needle guides, the needles extend at opposite positions relative to a cross-section of 5 biopsy unit. The biopsy unit of claim 14, wherein the second needle guide (401) extends along the periphery of the elongate member but displaced relative to the periphery in a direction away from the center of gravity in cross-sectional view of the elongate member. 10 The biopsy unit of claim 14, wherein the elongate member has a shape which is designed for mechanical coupling with a probe (700) and which must match with a recess (703) of a probe so as to provide a combination of the unit and the probe when coupled together which can be surrounded by a cylinder covering at least a portion of the elongate member length and having a diameter within the range of 12 to 30 millimeters. The biopsy unit of claim 14, wherein at least one of the needle guides is configured as a tubular member with an entrance end configured for a needle to penetrate and an exit end configured for the needle to project from the needle guide. A biopsy unit according to claim 14, wherein markings on the biopsy needle guide correspond to 25 respective markings on obtained biplane images when displayed on a screen display.