Devices and methods for free hand transperinal prostate needle guidance

Abstract

A biopsy guide for guiding biopsy needles towards a body organ includes a clasp for attaching to an ultrasound probe. The biopsy guide includes in addition a guide tower extending upwards away from the clasp that in turn includes a plurality of parallel guide channels placed one above the other and defining each a needle passage that extends through the guide tower between rear and forward open ends. Each guide channel at least along a rear section thereof opens laterally sideways along a slit that has a width sized to be generally similar to or larger than a width of the needle passage.

Description

[0001] DEVICES AND METHODS FOR FREE HAND TRANSPERINAL

[0002] PROSTATE NEEDLE GUIDANCE

[0003] TECHNICAL FIELD

[0004]

[0001] Embodiments of the invention relate to devices and methods for techniques for free hand transperinal prostate needle guidance, e.g. for biopsies and / or treatments, and in particular to such techniques that rely on real-time imaging.

[0005] BACKGROUND

[0006]

[0002] Prostate biopsies are used for diagnosing prostate cancer by obtaining tissue samples from the prostate gland. A Freehand transperineal biopsy accesses the prostate through the perineum (area between the scrotum and anus) by manually guiding an ultrasonic probe and a biopsy needle without use of a stepper stabilizer or other means to mechanically control the position of the US probe.

[0007]

[0003] By relying on real-time imaging, such as ultrasound, location sensors (e.g. EM sensors) and a fusion software which defines the suspicious targets imported from an MRI scan, the needle is guided to the precise location within the prostate where samples are needed. A typical example of imaging using ultrasound for such biopsy procedures involves inserting an ultrasound probe into the rectum to obtain detailed images.

[0008]

[0004] Several treatment options carried via insertion of treatment needles / applicators typically through the perineum are available (e.g. cryoablation, laser, PDT-photo dynamic therapy). One of the common methods is Cryoablation, also known as cryotherapy or cryosurgery, which is a treatment option for prostate cancer that involves freezing the cancerous tissues to destroy them.

[0009]

[0005] A transperineal ultrasound probe is typically used to guide the placement of cryoprobes, which are thin needles inserted into the prostate through the perineum. Multiple cryoprobes may be placed in and around the tumor within the prostate, and a freezing cycle e.g. utilizing argon gas that is circulated through the cryoprobes, can be used to create extremely low temperatures that freeze the prostate tissue.

[0010] SUMMARY

[0011]

[0006] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

[0012]

[0007] In an embodiment there is provided a biopsy guide for guiding biopsy needles towards a body organ, the biopsy guide comprising: a clasp for attaching to an ultrasound probe, and a guide tower extending upwards away from the clasp, wherein the guide tower comprising a plurality of parallel guide channels placed one above the other and defining each a needle passage extending through the guide tower between rear and forward open ends, and wherein each guide channel at least along a rear section thereof opens laterally sideways along a slit having a width that is sized to be generally similar to or larger than a width of the needle passage.

[0013]

[0008] In another embodiment there is provided a sampling device for guiding biopsy needles towards a body organ, the sampling device comprising: a base comprising a grip for attaching to an ultrasound probe, and biopsy guide comprising a clasp for attaching to an ultrasound probe and a guide tower extending upwards away from the clasp, the guide tower comprising a plurality of parallel guide channels placed one above the other and defining each a needle passage extending through the guide tower between rear and forward open ends, and wherein each guide channel at least along a rear section thereof opens laterally sideways along a slit having a width that is sized to be generally similar to or larger than a width of the needle passage.

[0014]

[0009] In yet a further embodiment there is provided a therapeutic guide for guiding therapeutic needles towards a body organ, the therapeutic guide comprising: a clasp for attaching to an ultrasound probe, a core extending upwards away from the clasp, and a removable shield, the core comprising a plurality of parallel guide channels placed one above the other and define each a needle passage that opens laterally sideways, wherein the removable shield when attached to the core is adapted to enclose and bound the guide channels at their open lateral sides.

[0015]

[0010] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the figures and by study of the following detailed descriptions.

[0016] BRIEF DESCRIPTION OF THE FIGURES

[0017] [Oi l] Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative, rather than restrictive. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

[0018]

[0012] Fig. 1 schematically shows an ultrasound probe and an embodiment of a sampling device mounted upon the probe;

[0019]

[0013] Fig. 2 schematically shows a partial exploded view of Fig. 1, showing a base and a biopsy guide of the sampling device being detached one from the other and from the probe;

[0020]

[0014] Fig. 3 schematically shows a closer view of the base;

[0021]

[0015] Fig. 4 schematically shows a closer view of the biopsy guide;

[0022]

[0016] Fig. 5A schematically shows a portion of the biopsy guide seen within the dashed-ellipse marked as IV in Fig. 4;

[0017] Fig. 5B schematically shows a partial cross sectional view the biopsy guide as seen in plane B-B that is marked in Fig. 5A;

[0023]

[0018] Fig. 6 schematically shows an ultrasound probe and an embodiment of a therapeutic device mounted upon the probe;

[0024]

[0019] Figs. 7A and 7B schematically show a treatment guide of the therapeutic device of Fig. 6 in respective non-operating and operative states; and

[0025]

[0020] Figs. 8A and 8B schematically show, respectively, perspective views of a removable shield and a base structure of the treatment guide.

[0026]

[0021] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated within the figures to indicate like elements.

[0027] DETAILED DESCRIPTION

[0028]

[0022] Attention is first drawn to Fig. 1 schematically showing an ultrasound probe 10 having a longitudinal axis Y and an embodiment of a sampling device 12 mounted upon the probe 10. Axis Y defines opposing forward are rear directions of the probe. The forward direction defines a distal side of the probe, which is designed to lead and enter first into a body organ to be scanned. An ultrasound probe used for sampling and obtaining biopsies within the prostate, such as the one seen in Fig. 1, may be of various types such as typically a transrectal or a transperineal ultrasound probe.

[0029]

[0023] Typically, such a probe includes buttons 1 that allow a user to perform various functions such as capturing images (and the like). These buttons 1 are located on a handle 2 of the probe often along an upper side of the handle where the thumb naturally rests when holding the probe.

[0030]

[0024] In Fig. 1 an image plane P of the probe 10 is displayed, which is the cross-sectional slice of a scanned object that is captured during the probe’s ultrasound examination. The probe’s longitudinal axis Y is typically included within image plane P.

[0031]

[0025] As seen, the sampling device 12 is adapted to guide a biopsy needle 14 along an axis G that is included within image plane P towards a targeted site within a body, such as a target site within a prostate of a patient undergoing ultrasound examination by probe 10.

[0032]

[0026] Axis G may be generally parallel or inclined with respect to the probe’s axis Y. As seen and discussed e.g. with respect to Fig. 5A, the sampling device includes a plurality of guide channels typically parallel one to the other and each being suitable for advancing a biopsy needle in a forward direction along a respective axis G.

[0033]

[0027] Attention is drawn to the partial exploded view of Fig. 2 showing a base 121 and a biopsy guide 122 of the sampling device 12.

[0034]

[0028] The base 121 includes a grip 1211 that has a hollow passage 1212 formed therein along an axis C of the base. The base 121 via its grip 121 can securely fit onto and grip the probe’s handle, which in turn is placed within passage 1212 resulting in axes C and Y being generally collinearly aligned.

[0035]

[0029] The base 121 also includes a housing 1213 here formed on an outer side of its grip 1211 for securing therein a sensor 16. The sensor 16 may be of any form, such as a magnetic sensor, and may be used for tracking the location of the sampling device 12 during use when coupled to the probe 10. The base 121 as seen may also include a guide slot 1214 on an outer side of its grip 1211.

[0036]

[0030] Attention is drawn to Fig. 3 showing a rear perspective of the base as viewed generally along axis C.

[0037]

[0031] It is noted that the up and down directional terms seen in Fig. 3 correspond and align with the up and down directional terms of the assembly of the sampling device 12 and probe 10 seen in Fig. 1.

[0038]

[0032] In addition it is noted that the directional terms "down", "below" and "bottom" (and derivatives thereof) define identical directions; as well as "up", "above" and "top" (and derivatives thereof) define identical directions.

[0033] The base can here be seen including an axially extending slit 1215 that is formed along a lower side of its grip 1211 to impart flexibility to the base as it is fitted onto the probe’s handle 2.

[0039]

[0034] Also seen in Fig. 3 is that the housing 1213 and guide slot 1214 - are generally positioned at upper opposing lateral sides of its grip. Such relative positioning may be defined by the housing 1213 and guide slot 1214 being spaced apart one from the other by an obtuse angle a about the base’s axis C. In the example seen, angle a is about 120 degrees.

[0040]

[0035] Spacing apart the housing 1213 and guide slot 1214 facilitates in leaving the upper side of the probe’s handle free of obstructions that may interfere with a user’s ability to access the buttons 1 of the probe.

[0041]

[0036] Attention is drawn to Fig. 4 schematically showing a closer view of the biopsy guide 122. The biopsy guide as seen includes a clasp 1221 and a guide tower 1222 that extends upwards from an upper side of the clasp. Also in this figure, the biopsy guide can be seen including a locating rod 1223 that extends rearward from an outer lateral side of the clasp 1221.

[0042]

[0037] As seen in Fig. 1, the biopsy guide is assembled to the probe by fitting its clasp 1221 over the probe and placing its locating rod 1223 through the guide slot 1214 of the base 121. The locating rod may include scale markings along its length to assist in locating the biopsy guide 122 at an adjustable distance from the base 121.

[0043]

[0038] Attention is drawn to Figs. 5 A and 5B providing closer views of the guide tower 1222. The guide tower 1222 as seen includes a plurality of spaced apart guide channels 5 placed one above the other, each defining a respective axis G along which a biopsy needle may be advanced in the forward direction. The guide channels 5 typically extend parallel to each other.

[0044]

[0039] Each guide channel 5 opens out to a given lateral side of the guide tower and includes a forward section SI and a rear section S2. The forward section SI opens out via a slit having a first width Al and the rear section S2 opens out via a slit having a second width A2, which is larger than the first width Al. In this example the guide tower includes a pair of slanted faces 9 converging inwards towards the slit leading into each guide channel 5 at its rear section S2.

[0045]

[0040] In this example each guide channel 5 includes a generally cylindrical formation having a diameter D and the first width Al is smaller than D (as best seen in Fig. 5B) and the second width A2 is generally similar to D (as best seen in Fig. 5A).

[0046]

[0041] By forming the slits leading into each guide channel 5 to be wider at the rear section S2 and at least equal to D, a physician using sampling device 12 may easily manually manipulate and place a tip region of a biopsy needle 14 laterally sideways into the guide channel’s rear section S2.

[0047]

[0042] By then urging the biopsy needle 14 forwardly, increasingly larger sections of the biopsy needle 14 will enter the forward section S2 where they are laterally bound and secured within the guide channel 5, and hence the biopsy needle 14 can be easily urged further to protrude in the forward direction out of the guide tower to obtain a sample from a body organ.

[0048]

[0043] Attention is drawn to Fig. 6 schematically showing an ultrasound probe 10 and an embodiment of a therapeutic device 22 mounted upon the probe. An ultrasound probe used for treating a body organ such as the prostate, may be of various types such as typically a transperineal ultrasound probe.

[0049]

[0044] Similar to the discussion with respect to Fig. 1, an image plane P of the probe 10 is displayed, which is a cross-sectional slice of a scanned object that is captured during the probe’s ultrasound examination.

[0050]

[0045] The therapeutic device 22 includes a base 121 and a therapeutic guide 222. The base 121 and probe 10 seen and discussed in the former figures may be the same as those used during a diagnostic stage, and hence after completing a diagnostic stage - the biopsy guide 122 in certain cases may be replaced by the therapeutic guide 222, and while using the same probe 10 and base 121 a therapeutic procedure may be performed.

[0046] Attention is drawn to Figs. 7A and 7B. The therapeutic guide 222 may include a clasp 2221 and a locating rod 2223 that may be generally similar to the clasp 1221 and a locating rod 1223 of the biopsy guide 122.

[0051]

[0047] A tower assembly 2222 of the therapeutic guide 222 includes a core 2222a and a removable shield 2222b that can be assembled over the core. The clasp 1221, locating rod 1223 and core 2222a may be formed as a unitary one piece base structure 777 of the treatment guide, while the removable shield 2222b may be formed as a separate part that is attachable to or detachable from the core 2222a. The core includes a plurality of spaced apart guide channels 55 placed one on top of the other and typically parallel one to the other.

[0052]

[0048] Each guide channel 55 defines an axis T along which a therapeutic needle (not shown) may be advanced towards a body organ to be treated. Axis T may be included within image plane P and may be generally parallel to or inclined with respect to axis Y of the probe.

[0053]

[0049] Each guide channel 55 as seen in the enlarged section in Fig. 7 A, also opens sideways to a first lateral side of the core 2222a along an axially extending slit 2215. A width of the slit 2215 in this example is generally similar to a diameter D of the guide channel 55, which is located more inwards relative to the slit towards an opposing second lateral side of the core.

[0054]

[0050] Placing the removable shield 2222b over the core 2222a is adapted to enclose and bound the guide channels 55 at their slits 2215, and by that form a barrier structured that ensures that therapeutic needles advanced through the guide channels remain securely within the guide channels, while preventing them from unintentionally slipping out through the open lateral sides of the guide channels.

[0055]

[0051] Placing the removable shield 2222b over the core 2222a may include snap fitting a snap arm 2216 of the removable shield into an anchor 2217 formed within the base structure 777 - in this example adjacent to where the clasp 2221 and locating rod 2223 meet. Such a snap arm 2216 may be formed at a lower side of a grip zone 2218 that is designed to be easily held and manipulated by two fingers of a user operating the treatment guide.

[0052] With attention additionally drawn to Figs. 8A and 8B it can be seen that the removable shield 2222b includes two generally parallel lateral legs 991, 992 that meet at an upper apex 993. The grip zone 2218 with its snap arm 2216 are formed in this example at a lower side of leg 991 on it outer lateral side. A cavity 8 formed in between the legs 991, 992 defines an area where the core 2222a is adapted to be placed when the removable shield is attached to the core.

[0056]

[0053] The removable shield can also be seen including a pin 999 that projects downwards into the cavity 8 from apex 993. This pin as seen is adapted to be received within an aperture 2219 formed at the upper side of the core, in the assembled state of the removable shield upon the core. Also seen is a rib 995 that projects along leg 992 on its side that faces into cavity 8. Rib 995 is adapted to be received within a key-way 996 formed on the outer side of the core, which is the cores lateral side that is opposite to its side where the guide channels 55 are formed.

[0054] In a therapeutic procedure, one or more therapeutic needles may be advanced via tower assembly 2222 towards a body organ. In one example, the therapeutic needle may be a cryoprobe suitable for freezing cancerous tissues.

[0057]

[0055] 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.

[0058]

[0056] 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.

[0059]

[0057] 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.

[0060]

[0058] 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.

[0059] 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.

Claims

CLAIMS:

1. A biopsy guide for guiding biopsy needles towards a body organ, the biopsy guide comprising: a clasp for attaching to an ultrasound probe, and a guide tower extending upwards away from the clasp, wherein the guide tower comprising a plurality of parallel guide channels placed one above the other and defining each a needle passage extending through the guide tower between rear and forward open ends, and wherein each guide channel at least along a rear section thereof opens laterally sideways along a slit having a width that is sized to be generally similar to or larger than a width of the needle passage.

2. The biopsy guide of claim 1, wherein each guide chaimel’s rear section extends forwardly from its rear open end.

3. The biopsy guide of claim 2, wherein each guide channel at least along a forward section thereof opens laterally sideways also along a slit having a width that is sized to be smaller than the width of the needle passage.

4. The biopsy guide of claim 3, wherein each guide chaimel’s forward section extends rearward from its forward open end.

5. The biopsy guide of claim 4, wherein the sideways direction is along an axis that is perpendicular to a plane including the axes of the guide channels.

6. The biopsy guide of claim 5, wherein the needle passages are generally cylindrical and the width of the each guide channel is its diameter.

7. The biopsy guide of claim 6 and comprising a pair of slanted faces converging inwards towards the slit leading into each guide channel at its rear section.

8. A sampling device for guiding biopsy needles towards a body organ, the sampling device comprising: a base comprising a grip for attaching to an ultrasound probe, and biopsy guide comprising a clasp for attaching to an ultrasound probe and a guide tower extending upwards away from the clasp, the guide tower comprising a plurality of parallel guide channels placed one above the other and defining each a needle passage extending through the guide tower between rear and forward open ends, and wherein each guide channel at least along a rear section thereof opens laterally sideways along a slit having a width that is sized to be generally similar to or larger than a width of the needle passage.

9. The sampling device of claim 8, wherein each guide channeTs rear section extends forwardly from its rear open end.

10. The sampling device of claims 8, wherein each guide channel at least along a forward section thereof opens laterally sideways also along a slit having a width that is sized to be smaller than the width of the needle passage.

11. The sampling device of claim 10, wherein each guide channel’s forward section extends rearward from its forward open end.

12. The sampling device of claim 8, wherein the sideways direction is along an axis that is perpendicular to a plane including the axes of the guide channels.

13. The sampling device of claim 8, wherein the needle passages are cylindrical and the width of the each guide channel is its diameter.

14. The sampling device of claim 8 and comprising a pair of slanted faces converging inwards towards the slit leading into each guide channel at its rear section.

15. The sampling device of claim 8, wherein the base comprises a housing and a guide slot each being formed on an outer side of the grip.

16. The sampling device of claim 15, wherein the grip defining a hollow passage formed about an axis C and the housing and guide slot being spaced apart one from the other by an obtuse angle a about axis C.

17. The sampling device of claim 16, wherein the biopsy guide comprising a locating rod that extends rearward from an outer side of the clasp and the biopsy guide is coupled to the base by locating a portion of its locating rod within base’s guide slot.

18. The sampling device of claim 16, wherein the housing is configured to secure therein a sensor, e.g. a magnetic sensor, for tracking the location of the sampling device.

19. A therapeutic guide for guiding therapeutic needles towards a body organ, the therapeutic guide comprising: a clasp for attaching to an ultrasound probe, a core extending upwards away from the clasp, and a removable shield, the core comprising a plurality of parallel guide channels placed one above the other and define each a needle passage that opens laterally sideways, whereinthe removable shield when attached to the core is adapted to enclose and bound the guide channels at their open lateral sides.

20. The therapeutic guide of claim 19, wherein each guide channel extends through the core between rear and forward open ends.

21. The therapeutic guide of claim 20, wherein the removable shield comprises two lateral legs that meet at an upper apex and define therebetween a cavity into which the core is adapted to be placed when the removable shield is attached to the core.

22. The therapeutic guide of claim 21, wherein the removable shield comprises a pin that projects into the cavity from the upper apex and a rib that extends along an inner side of one of the legs that faces into the cavity.

23. The therapeutic guide of claim 22, wherein in the attached state of the removable shield upon the core the pin and rib are adapted to be received, respectively, within an aperture and a key-way formed upon the core.

24. The therapeutic guide of claim 23, wherein the aperture is formed at an upper side of the core and the key-way is formed at an outer lateral side of the core that is opposite to the lateral side where the guide channels are located.

25. The therapeutic guide of any one of claims 22, wherein each one of the guide channels extends along a respective axis that is slanted relative to a longitudinal axis of the ultrasound probe.

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