NEEDLE GUIDANCE

FIELD OF THE INVENTION

The invention, in some embodiments, relates to the field of guided biopsy, aided by an imaging modality and sensors which in some embodiments facilitates the registration of imaging data and trans-perineal needle guide position.

BACKGROUND OF THE INVENTION

Prostate biopsy is currently the only method to confirm prostate cancer. Prostate biopsy is more frequently done in a trans-rectal approach due to the simplicity and lower costs of this procedure. However, prostate biopsy in a trans-perineal approach has several important advantages over the trans-rectal approach. First, the trans-rectal approach is associated with significantly higher risk of urinary tract infection and sepsis compared with the trans -perineal biopsy. Secondly, Trans-perineal approach enables easier access to the prostate apex and anterior zone, hence detects higher percentage of prostate cancer in these regions. And lastly, focal treatment has become a real option for prostate cancer in the last few years. The majority of focal treatments are done via the perineum; hence it is an advantage to plan the treatment on diagnostic data collected in the same approach.

Despite these clear advantages, trans-perineal approach is not commonly used, due to the costly equipment and general anesthesia it requires. Currently, trans perineal equipment is based on stepper stabilizer which fix the location of the template grid in respect to the US probe. In at least certain embodiments of the present invention, it is suggested to use separate locations data of the US probe and the template grid or any other needle guide under electro-magnetic field and create the registration via software and not via bulky and expensive mechanical solutions.

SUMMARY OF THE INVENTION

In recent years there is continuous trend towards more localized treatment. A localized diagnosis enables a localized intervention, leading to reducing collateral damage during and after treatment, decreasing patient suffering and inconvenience, reducing healing time and increasing healing likelihood and reducing overall treatment cost. Trans-perineal is the common approach for prostate treatment and specifically for focal treatment, hens it is an advantage to perform the diagnostic biopsies in the same approach, in addition to the risk of infection from a biopsy taken in a trans-rectal approach. Currently trans-perineal biopsy relays on a stepper stabilizer equipment, which holds the US probe in a fixed location relative to the template grid, the stepper allows to fix the needle optional paths on the US image. The disclosed method, according to some embodiments thereof, allows to follow the location of the needle's path in respect to the US image based on EM sensors without the need for expensive and bulky equipment.

According to an aspect of the invention there is provided a method for using sensor based trans-perineal needle guidance, comprising:

Providing an imaging modality comprising at least one imaging probe designed to collect data from different positions in reference to the organ imaged, wherein the probes are configured for collecting image data of physical objects, and the image data represents a region in space corresponding to the location of the probe at the time the image data is collected;

Providing a tracking modality configured for providing data on the location of an object along pre-selected coordinates as a function of time;

Configuring the tracking modality to provide data on the location of at least one probe of the imaging modality as a function of time;

Configuring the tracking modality to provide data on the location of a trans-perineal needle guide, single needle guide or any fixed formation of needle entries; using the imaging modality and the probe thereof, collecting image data of an organ in a body;

Providing a registration modality, to register the needle paths data with the image data of the organ. Further aspects of the present invention are exemplified in the following:

1. A system comprising of at least two tracking sensors, with at least one of them fixed on the imaging probe and a second sensor fixed on a trans-perineal needle guide.

2. A method to register trans-perineal needle guide location with the image data in real-time.

3. A method to stabilize trans-perineal needle guide to the perineum.

4. A method that enables monitoring of the trans-perineal needles inserted to the prostate based on the registration of image data collected and the location data collected form at least two tracking sensors, on the needle guide and on the imaging probe.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, takes precedence. As used herein, the terms "comprising", "including", "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. These terms encompass the terms "consisting of" and "consisting essentially of".

As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

Embodiments of methods and/or systems of the invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. Some embodiments of the invention are implemented with the use of components that comprise hardware, software, firmware or combinations thereof. In some embodiments, some components are general-purpose components such as general-purpose computers or oscilloscopes. In some embodiments, some components are dedicated or custom components such as circuits, integrated circuits or software.

For example, in some embodiments, part of an embodiment is implemented as a plurality of software instructions executed by a data processor, for example which is part of a general-purpose or custom computer. In some embodiments, the data processor or computer comprises volatile memory for storing instructions and/or data and/or a non volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. In some embodiments, implementation includes a network connection. In some embodiments, implementation includes a user interface, generally comprising one or more of input devices (e.g. allowing input of commands and/or parameters) and output devices (e.g. allowing reporting parameters of operation and results).

BRIEF DESCRIPTION OF THE FIGURES

Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments of the invention may be practiced. The figures are for the purpose of illustrative discussion and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the Figures:

FIG. 1 schematically depicts a flow chart of a method for sensor based trans-perineal needle guidance, in accordance with some embodiments of the disclosure;

FIG. 2 schematically depicts an embodiment of a system configured to carry out the method of FIG. 1; FIG. 3 schematically depicts another embodiment of a system configured to carry out the method of FIG. 1; and

FIGS. 4 and 5 schematically depicts an embodiment of a template grip that can be used in any one of the methods and systems described herein.

DESCRIPTION OF SOME EMBODIMENTS OF THE INVENTION

The principles, uses, and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art is able to implement the invention without undue effort or experimentation.

Before explaining at least one embodiment in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. The invention is capable of other embodiments or of being practiced or carried out in various ways. The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting.

Figure 1 schematically illustrates a flow chart of a method according to an aspect of the invention.

The method may comprise step 102 of providing an imaging modality comprising at least one probe, wherein the at least one probe is configured for collecting image data of physical objects, and the image data represents a region in space corresponding to the location of the probe at the time the image data is collected.

The method may further comprise step 104 of providing a tracking modality configured for providing data on the location of an object along pre-selected coordinates as a function of time.

The method may further comprise step 106 of configuring the tracking modality to provide data on the location of the at least one probe of the imaging modality as a function of time.

The method may further comprise step 108 of configuring the tracking modality to provide data on the location of at least one needle guide or any fixed formation of needle entries.

The method may further comprise step 110 of using the imaging modality and the at least one probe for collecting image data during the procedure process;

The method may further comprise step 112 of providing a registration modality to register the needle paths data with the image data of the organ. A male patient in lithotomic position is sketched in figure 2, and a template grid (optional needle guide) 202 is illustrated being fixed to the male's perineum, in this example via possible adhesive tape 204. In this example one imaging modality in form of an ultrasound scanner 210 is seen in use with a probe, here being embodied as a trans-rectal ultrasound (TRUS) transducer 212 placed in the rectum. It is noted that the probe being used may be of other types, such as a trans-perineal probe, an abdominal probe (and the like). It is noted in addition that more than one probe may be used for scanning objects, possibly the same scanned object, in accordance with the various embodiments of the present disclosure.

Ultrasound scanner 210, may be configured to provide an ultrasound image obtained from ultrasound image data collected by the TRUS transducer 212. In the example shown of ultrasound scanner 210, TRUS transducer 212 may be positioned at a series of sequential positions along rectum 208 to collect a series of two-dimensional (2D) images. In case the obtained 2D images contain a target area of interest, such as in this example the prostate transverse sections, the images may be segmented and arranged together to obtain a resulting scan, such as a 3D surface of the prostate. A spatial location may then be assigned to the resulting scan via a tracking modality, in this exampled embodied by a tracking system 220.

Tracking system 220 may be of an electro-magnetic or electro-optic type that is configured to obtain, substantially in real time, a spatial location of suitable sensors relative to the origin of a pre-selected coordinates system. Tracking system 220 in its electro-magnetic form seen in these images, includes a transmitter 222 that produces a local electromagnetic field. Tracking system 220 further includes or is arranged to track sensors 224 such as sensor 224a, sensor 224b. Each sensor 224 that is suitable for being tracked by an electro-magnetic, may be configured to sense the EM field generated by transmitter 222 at the location of the sensor, and to obtain a signal corresponding to the sensed EM field. Upon receiving such signals from each sensor, tracking system 220 calculates the spatial location and angular orientation of the sensor, relative to the location of transmitter 222.

It is noted that in embodiments that make use of tracking systems of other types, such as electro-optic type tracking systems, other arrangements may be suitably envisioned. For example, the sensors being used may be suitable for detection by an electro-optic tracking system, and may be suitably formed to allow calculation of their spatial location.

Sensor 224a in the shown example may be firmly attached to TRUS transducer 212 in order to enable tracking system 220 to obtain the spatial location of TRUS transducer 212, along the selected coordinates that are attached to the body. Consequently, image data collected by TRUS transducer 212, having a known spatial relation with TRUS transducer 212, may be assigned location data, as is further detailed below. Likewise, Sensor 224b may be firmly attached to the template grid 202 and by that enable tracking system 220 to obtain the spatial location of the needle entries in grid 202. A main controller 240 may be configured to receive ultrasound images from ultrasound scanner 210, possibly using an image grabber 242, and to receive location and orientation data of sensors 224 from tracking system 220. Using the correspondence of the image data to the location of TRUS transducer 212 and template grid 202 at the time the image data was collected, main controller may be further configured to assign location data to the received ultrasound images, so that e.g. substantially each pixel in an ultrasound image obtained from the image data, is assigned a location in a coordinate system attached to the body under treatment.

Such transformation into a similar common coordinate system of the scanned data obtained by the ultrasound scanner 210 and of the needle entries in grid 202, may assist a physician treating a patient such as that shown in Fig. 2, in choosing a suitable needle entry through which to approach a desired location within the resulting scan of the target area of interest of the patient. Such a desired location may be identified by the physician within the scan as an area where a biopsy is required or any other suitable treatment or surgical procedure may be chosen.

Figure 3 generally differs from the arrangement seen in figure 2, by illustrating use of a slightly differently shaped and/or arranged template grid 202. As suggested by this illustration, the template grid may assume various formations. For example, needle entries within the template grid may be sized differently e.g. to accommodate passage of differently sized tools/needles towards a desired location within the resulting scan. Needle entries may be formed along paths through the template grid that have varying angles one to the other. For example, needle entries at edges of the template grid may be formed along slated paths relative to needle entries located closer to a center of the template grid that may be formed along paths that are generally orthogonal to an outer face of the grid.

Attention is drawn to Figs. 4 and 5 schematically illustrating an embodiment of a template grid 202 that includes an integrally formed sensor pocket 2022 suitable for detachably receiving therein a sensor 224b to enable tracking system 220 to obtain the spatial location of the needle entries in grid 202.

Preferably, sensor pocket 2022 is suited to ensure that the sensor is inserted therein in a pre-defined orientation in order to ensure a pre-defined calibrating of the location and orientation of the needle entries relative to the local coordinate system of the sensor. Ensuring that the sensor is inserted into the sensor pocket in such a pre-defined orientation may assist in calculating the location and orientation of such needle entries in the common coordinate system in which also the coordinate system of the body under treatment is computed.

Ensuring insertion of the sensor into the insert pocket in such a pre-defined orientation may be accomplished in various ways, such as by providing a tactile indication that the insertion was suitably accomplished, or any other indication. In the example shown in Fig. 5, the sensor pocket is shown being provided with a window 20221 through which a marker 7 of the sensor may be viewed when the sensor is fully and correctly inserted into the sensor pocket in its pre-defined orientation.

Also shown in this view is that the sensor pocket may be formed in order to securely resiliently clamp the sensor therein. For this purpose, the sensor pocket may be provided with clamping jaws 20223 (here two) that may each be forced away from a base jaw 20225 of the sensor pocket giving rise to a resilient force which clamps the sensor in the sensor pocket. Resiliency of each clamping jaw 20223 may be obtained by resiliently connecting it via a recess 20224 to the base jaw 20225 forming a single integral piece therewith. A sensor clamped within the sensor pocket may engage abutment faces 20222 formed on an innerface of the pocket in between pairs of adjacent recesses 20224.

The template grid in Figs. 4 and 5 is also seen being provided with lateral wings 2021 that extend along opposing lateral sides of the grid. Such wings may be provided with an adhesive tape that is placed on lower sides 20211 of each wing (see lower side indicated in Fig. 5), which is suited to adhesively engage the perineum of the patient during use.

In the description and claims of the present application, each of the verbs, "comprise" "include" and "have", and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of members, components, elements or parts of the subject or subjects of the verb.

Further more, while the present application or technology has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and non-restrictive; the technology is thus not limited to the disclosed embodiments. Variations to the disclosed embodiments can be understood and effected by those skilled in the art and practicing the claimed technology, from a study of the drawings, the technology, and the appended claims.

In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single processor or other unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures can not be used to advantage.

The present technology is also understood to encompass the exact terms, features, numerical values or ranges etc., if in here such terms, features, numerical values or ranges etc. are referred to in connection with terms such as "about, ca., substantially, generally, at least" etc. In other words, "about 3" shall also comprise "3" or "substantially perpendicular" shall also comprise "perpendicular". Any reference signs in the claims should not be considered as limiting the scope. Although the present embodiments have been described to a certain degree of particularity, it should be understood that various alterations and modifications could be made without departing from the scope of the invention as hereinafter claimed.